<PAGE> 1
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON OCTOBER 17, 1997
REGISTRATION NO. 333-
================================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
------------------------
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
------------------------
CELLEGY PHARMACEUTICALS, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
<TABLE>
<S> <C> <C>
CALIFORNIA 2834 82-0429727
(STATE OR OTHER JURISDICTION OF (PRIMARY STANDARD INDUSTRIAL (I.R.S. EMPLOYER IDENTIFICATION
INCORPORATION OR ORGANIZATION) CLASSIFICATION CODE NUMBER) NO.)
</TABLE>
1065 E. HILLSDALE BLVD., SUITE 418
FOSTER CITY, CALIFORNIA 94404
(650) 524-1600
(ADDRESS AND TELEPHONE NUMBER OF REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES)
K. MICHAEL FORREST
PRESIDENT AND CHIEF EXECUTIVE OFFICER
CELLEGY PHARMACEUTICALS, INC.
1065 E. HILLSDALE BLVD., SUITE 418
FOSTER CITY, CALIFORNIA 94404
(650) 524-1600
(NAME, ADDRESS AND TELEPHONE NUMBER OF AGENT FOR SERVICE)
COPIES TO:
<TABLE>
<S> <C>
C. KEVIN KELSO, ESQ. BRIAN C. CUNNINGHAM, ESQ.
FENWICK & WEST LLP LANA K. HAWKINS, ESQ.
TWO PALO ALTO SQUARE COOLEY GODWARD LLP
PALO ALTO, CALIFORNIA 94306 5 PALO ALTO SQUARE
(650) 494-0600 PALO ALTO, CALIFORNIA 94304-2155
(650) 843-5000
</TABLE>
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
As soon as practicable after the effective date of this Registration Statement.
If any of the securities being registered on this Form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box. [ ]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, check the following box and
list the Securities Act registration statement number of the earlier effective
registration statement for the same offering. [ ]
- ---------
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ]
- ---------
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. [ ]
CALCULATION OF REGISTRATION FEE
- --------------------------------------------------------------------------------
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<S> <C> <C> <C> <C>
- ------------------------------------------------------------------------------------------------------------
PROPOSED MAXIMUM PROPOSED MAXIMUM
TITLE OF EACH CLASS OF AMOUNT TO BE OFFERING PRICE AGGREGATE AMOUNT OF
SECURITIES TO BE REGISTERED REGISTERED(1) PER SHARE(2) OFFERING PRICE(2) REGISTRATION FEE
- ------------------------------------------------------------------------------------------------------------
Common Stock, no par value
per share................. 2,587,500 shares $8.625 $22,317,188 $6,763
============================================================================================================
</TABLE>
(1) Includes 337,500 shares that the Underwriter has the option to purchase to
cover over-allotments, if any.
(2) Estimated pursuant to Rule 457(c) solely for the purpose of calculating the
amount of the registration fee.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A),
MAY DETERMINE.
================================================================================
<PAGE> 2
Information contained herein is subject to completion or amendment. A
registration statement relating to these securities has been filed with the
Securities and Exchange Commission. These securities may
not be sold nor may offers to buy be accepted prior to the time the
registration statement becomes effective. This prospectus shall not
constitute an offer to sell or the solicitation of an offer
to buy nor shall there be any sale of these securities in any State in
which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such State.
SUBJECT TO COMPLETION, DATED OCTOBER 17, 1997
2,250,000 SHARES
LOGO
COMMON STOCK
------------------------
All of the shares of Common Stock offered hereby are being sold by Cellegy
Pharmaceuticals, Inc. ("Cellegy" or the "Company"). The Company's Common Stock
is listed on the Nasdaq SmallCap Market under the symbol "CLGY." On October 16,
1997, the last reported sale price of
the Common Stock was $8.50 per share. The Company has applied to have the Common
Stock approved for quotation on the Nasdaq National Market under the symbol
"CLGY."
THE COMMON STOCK OFFERED HEREBY INVOLVES A HIGH DEGREE OF RISK.
SEE "RISK FACTORS" BEGINNING ON PAGE 6.
------------------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION, NOR HAS THE SECURITIES
AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
<TABLE>
<CAPTION>
=================================================================================================
PRICE TO PROCEEDS TO
PUBLIC UNDERWRITING COMPANY(2)
DISCOUNT(1)
- -------------------------------------------------------------------------------------------------
<S> <C> <C> <C>
Per Share......................... $ $ $
Total(3).......................... $ $ $
============================================================================================
</TABLE>
(1) Excludes the issuance of a warrant to the Underwriter (the "Underwriter
Warrant") to purchase up to 125,000 shares of Common Stock, exercisable for
a period of five years commencing on the first anniversary of the date of
this Prospectus, at an exercise price of 130% of the public offering price
set forth above. The Underwriter has been granted certain registration
rights under the Securities Act of 1933, as amended, with respect to the
Common Stock issuable upon exercise of the Underwriter Warrant. The Company
has agreed to indemnify the Underwriter against certain liabilities,
including liabilities under the Securities Act of 1933, as amended. See
"Underwriting."
(2) Before deducting expenses of the offering payable by the Company estimated
at $466,000.
(3) The Company has granted the Underwriter an option, exercisable within 30
days of the date hereof, to purchase up to 337,500 additional shares of
Common Stock at the Price to Public per share, less the Underwriting
Discount, for the purpose of covering over-allotments, if any. If the
Underwriter exercises such option in full, the total Price to Public,
Underwriting Discount, and Proceeds to Company will be $ ,
$ and $ , respectively. See "Underwriting."
------------------------
The shares of Common Stock are offered by the Underwriter when, as and if
delivered to and accepted by it, subject to its right to withdraw, cancel or
reject orders in whole or in part and subject to certain other conditions. It is
expected that delivery of the certificates representing the shares will be made
against payment on or about , 1997 at the office of Oppenheimer &
Co., Inc., Oppenheimer Tower, One World Financial Center, New York, New York
10281.
------------------------
(LOGO)
The date of this Prospectus is , 1997.
<PAGE> 3
PRODUCTS UNDER DEVELOPMENT
The following table summarizes certain information concerning Cellegy's
clinical and preclinical product candidates and is qualified in its entirety by
the more detailed information appearing elsewhere in this Prospectus. The
development and commercialization of the Company's product development
candidates are subject to numerous risks and uncertainties. See "Risk Factors."
- --------------------------------------------------------------------------------
<TABLE>
<CAPTION>
DEVELOPMENT TECHNOLOGIES
PRODUCTS INDICATIONS STATUS UTILIZED
------------------------ ------------------------ ------------------------ ------------
<S> <C> <C> <C>
PRESCRIPTION TOPICAL THERAPEUTICS
Glylorin Non-bullous congenital Phase III trials in Proprietary
ichthyosiform progress
erythroderma
Ichthyosis vulgaris Phase II trials planned Proprietary
PRESCRIPTION PRODUCTS USING TRANSDERMAL DRUG DELIVERY TECHNOLOGY
Testosterone gel Hypogonadism (hormone Pilot studies in humans CELLEDIRM
therapy for male planned for late 1997
andropause)
Testosterone gel Female hormone therapy Preclinical evaluation CELLEDIRM
Estrogen-testosterone Female hormone therapy Research PERMEATE
gel
CELLEDIRM
Immunosuppressive drug Psoriasis Research PERMEATE
CELLEDIRM
COSMECEUTICAL PRODUCTS
Anti-wrinkling products* Photodamaged and aging In human testing CELLEDIRM
skin
Anti-irritant cream Irritated, red, itchy Formulation development CELLEDIRM
skin
Other skin care products Dry and disrupted skin Formulations complete; CELLEDIRM
ready for marketing
</TABLE>
- --------------------------------------------------------------------------------
* References in this Prospectus to "anti-wrinkling," "anti-wrinkling products"
or the "anti-wrinkling market" are intended to refer to a cosmeceutical
product category that the Company believes is generally understood in the
marketplace, and are not intended to describe any claims that the Company's
cosmeceutical products act in any way other than as cosmetics as defined under
applicable laws. The term "cosmeceuticals" refers to products which, if they
satisfy the definition of a cosmetic under applicable federal laws and if they
are not also drugs under those laws, are not subject to the same requirements
as drug products. See "Risk Factors -- Possible FDA Regulation of
Cosmeceutical Products as Drugs" and "Business -- Government Regulation."
IN CONNECTION WITH THIS OFFERING, THE UNDERWRITER MAY OVER-ALLOT OR EFFECT
TRANSACTIONS WHICH STABILIZE OR MAINTAIN THE MARKET PRICE OF THE COMPANY'S
COMMON STOCK AT A LEVEL ABOVE THAT WHICH MIGHT OTHERWISE PREVAIL IN THE OPEN
MARKET. SUCH TRANSACTIONS MAY BE EFFECTED ON THE NASDAQ NATIONAL MARKET, OR
OTHERWISE. SUCH STABILIZING, IF COMMENCED, MAY BE DISCONTINUED AT ANY TIME.
IN CONNECTION WITH THIS OFFERING, THE UNDERWRITER MAY ENGAGE IN PASSIVE
MARKET MAKING TRANSACTIONS IN THE COMPANY'S COMMON STOCK ON THE NASDAQ NATIONAL
MARKET IN ACCORDANCE WITH RULE 103 OF REGULATION M. SEE "UNDERWRITING."
<PAGE> 4
PROSPECTUS SUMMARY
The following summary is qualified in its entirety by the more detailed
information and the financial statements (and notes thereto) appearing elsewhere
in this Prospectus. Except as otherwise noted herein, information in this
Prospectus assumes no exercise of the Underwriter's over-allotment option. An
investment in the shares of Common Stock offered hereby involves a high degree
of risk. Prospective investors should consider carefully the information
provided under "Risk Factors."
The term "Cosmeceuticals" is not defined by the U.S. Food and Drug
Administration (the "FDA") but refers to products that, depending on several
factors, may not be subject to the same requirements as drug products. See "Risk
Factors -- Possible FDA Regulation of Cosmeceutical Products as Drugs" and
"Business -- Government Regulation."
Cellegy is a biopharmaceutical company engaged in the development of
prescription drugs and cosmeceuticals to address a variety of diseases and
conditions utilizing its patented transdermal and topical delivery technologies.
Cellegy's first prescription drug, Glylorin, is a novel treatment for certain
forms of ichthyosis, a family of incurable skin diseases. Glylorin has been
licensed by Cellegy to Glaxo Wellcome, Inc. ("Glaxo") and is currently in Phase
III clinical trials in the United States. Cellegy is also evaluating several
prescription drugs including a transdermal testosterone gel for the treatment of
hypogonadism, a condition that frequently results in lethargy and reduced libido
in men above the age of 40. In addition to its prescription drugs, Cellegy is
testing and developing a line of anti-wrinkling cosmeceutical products which the
Company believes will address the skin care needs of an affluent and aging
population.
The Company's principal technologies consist of PERMEATE and CELLEDIRM.
PERMEATE is a patented topical drug delivery system which has been found in
preclinical evaluations to permit delivery of larger or insoluble drugs into the
blood stream or into the skin itself. These drugs include peptides that to the
Company's knowledge are not deliverable using methods employed in currently
approved transdermal products. CELLEDIRM (Cellegy's Dermal Inflammatory Response
Modulators) is a group of compounds identified by Cellegy's scientists that have
been found in preclinical evaluations to reduce or eliminate irritation caused
by many substances that come into contact with the skin. The Company's CELLEDIRM
technology is being developed as an adjunct to the PERMEATE technology to
mitigate the skin irritation problems associated with transdermal drug delivery,
and to improve existing prescription drugs and cosmeceutical products.
Glylorin, the Company's most advanced topical prescription candidate, is
currently in Phase III clinical trials for non-bullous congenital ichthyosiform
erythroderma ("n-CIE"). n-CIE is a severe form of congenital primary ichthyosis
("CPI"), a group of incurable skin conditions for which there is currently no
satisfactory treatment. Ichthyosis is a family of related skin diseases
characterized by a severe scaling of the skin that frequently affects large
areas of the body. In all forms of ichthyosis, skin cells form a rigid, thick
surface layer of scales that often discolor and crack. Many of the most severely
afflicted infants die shortly after birth from dehydration, hypothermia and
microbes, which enter through the damaged epidermis. Approximately 100,000
people in the United States, and at least an equal number of persons outside the
United States, are afflicted with CPI.
Based on Phase I and II clinical studies conducted by the Company, Glylorin
appears to be safe and effective in the treatment of n-CIE. The results from the
Company's Phase II clinical studies produced statistically significant
improvements in scaling, induration (swelling) and erythema (redness). After
developing the product through early Phase III clinical trials, Cellegy licensed
Glylorin to Glaxo in November 1996. Glaxo has completed patient enrollment for
the Phase III trial.
The Company's most advanced transdermal drug delivery candidate is a
testosterone gel. Based on preclinical studies to date, the Company believes its
proprietary gel product will be capable of providing therapeutic levels of
testosterone in a once-a-day topical application to a small area of the body.
Furthermore, by using CELLEDIRM, the Company believes its testosterone gel will
have a lower incidence of local skin irritation and other adverse skin reactions
than current patch products.
3
<PAGE> 5
The Company's most advanced cosmeceutical is an anti-wrinkling product
designed to mitigate the visible effects of photoaging and skin wrinkling.
Cellegy's anti-wrinkling product will be included in a line of products that the
Company expects to produce greater improvement to the skin's appearance and
cause less irritation than current market leading products. Cellegy commenced
human evaluation of this product line during the second quarter of 1997 and
expects to begin commercial sales during 1998.
Cellegy intends to utilize its delivery technologies (i) to produce
transdermal versions of existing FDA approved drugs, (ii) to develop topical or
transdermal formulations of new chemical entities in partnership with innovator
pharmaceutical or biotechnology companies and (iii) to develop high performance
cosmeceuticals. The Company plans to establish corporate partnerships to support
development and marketing of many of these products. Whenever possible, the
Company plans to retain certain marketing rights to products it develops for the
dermatology market, and Cellegy intends ultimately to build or acquire a sales
force to serve this market. Although Cellegy is focusing primarily on the
development of its own products and technologies, the Company may acquire
products, technologies or businesses consistent with its commercial objectives.
Cellegy's principal executive offices are located at 1065 E. Hillsdale
Blvd., Suite 418, Foster City, California 94404, and its telephone number is
(650) 524-1600. In this Prospectus, the term "Cellegy" or the "Company" refers
to Cellegy Pharmaceuticals, Inc., a California corporation, unless the context
otherwise requires.
Cellegy is a registered trademark of the Company. Glylorin is a registered
trademark that the Company has transferred to Glaxo. CELLEDIRM and PERMEATE are
trademarks of the Company. This Prospectus also includes trademarks of companies
other than the Company.
4
<PAGE> 6
THE OFFERING
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<S> <C>
Common Stock offered by the Company....... 2,250,000 shares
Common Stock to be outstanding after the
offering................................ 9,844,959 shares(1)
Use of proceeds........................... To fund clinical trials and research and
development expenses, and for general corporate
purposes, including working capital. See "Use of
Proceeds."
Proposed Nasdaq National Market
symbol.................................. CLGY(2)
</TABLE>
SUMMARY FINANCIAL INFORMATION
(IN THOUSANDS, EXCEPT PER SHARE DATA)
<TABLE>
<CAPTION>
NINE MONTHS
ENDED
YEARS ENDED DECEMBER 31, SEPTEMBER 30,
--------------------------- -----------------
1994 1995 1996 1996 1997
------- ------- ------- ------- -------
<S> <C> <C> <C> <C> <C>
STATEMENT OF OPERATIONS DATA:
Revenues.......................................... $ -- $ 1,000 $ 648 $ 15 $ 643
Total operating expenses.......................... 2,542 2,535 4,346 3,037 3,455
------- ------- ------- ------- -------
Operating loss.................................... (2,542) (1,535) (3,698) (3,022) (2,812)
Net loss applicable to common shareholders........ (2,543) (2,152) (4,782) (4,119) (2,493)
======= ======= ======= ======= =======
Pro forma net loss per share applicable to common
shareholders(3)................................. $ (0.76) $ (0.67) $ (1.11) $ (1.02) $ (0.41)
======= ======= ======= ======= =======
Shares used in computing pro forma net loss per
share(3)........................................ 3,344 3,206 4,307 4,050 6,076
</TABLE>
<TABLE>
<CAPTION>
SEPTEMBER 30, 1997
--------------------------
ACTUAL AS ADJUSTED(4)
------- --------------
<S> <C> <C>
BALANCE SHEET DATA:
Cash, cash equivalents and investments............................... $ 9,377 $ 26,889
Total assets......................................................... 9,841 27,353
Long-term obligations................................................ -- --
Deficit accumulated during the development stage..................... (17,431) (17,431)
Total shareholders' equity........................................... 9,114 26,626
</TABLE>
- ---------------
(1) Based on the number of shares outstanding as of September 30, 1997. Excludes
1,061,447 shares of Common Stock issuable upon the exercise of outstanding
stock options at a weighted average exercise price of $4.19 per share,
661,250 shares of Common Stock issuable upon the exercise of publicly traded
warrants issued in the Company's initial public offering (the "IPO
Warrants") at an exercise price of $9.375 per share, 832,061 other shares of
Common Stock issuable upon the exercise of other outstanding warrants at a
weighted average exercise price of $7.79 per share, and up to 125,000 shares
of Common Stock issuable upon exercise of the Underwriter Warrant. See
"Description of Capital Stock."
(2) The Common Stock and IPO Warrants are currently traded on the Nasdaq
SmallCap Market under the symbols "CLGY" and "CLGYW," respectively. The
Company has applied to have the Common Stock and the IPO Warrants quoted on
the Nasdaq National Market under the symbols "CLGY" and "CLGYW,"
respectively.
(3) See Note 1 of Notes to the financial statements of the Company appearing
elsewhere herein (the "Financial Statements") for an explanation of the
determination of the number of pro forma shares used in per share
calculations.
(4) Adjusted to reflect the sale of 2,250,000 shares of Common Stock offered
hereby and the application of the net proceeds therefrom at an assumed
public offering price of $8.50 per share. See "Use of Proceeds" and
"Capitalization."
5
<PAGE> 7
RISK FACTORS
An investment in the shares of Common Stock offered hereby is speculative
in nature and involves a high degree of risk. In addition to the information
contained in this Prospectus, the following factors should be considered
carefully in evaluating the Company and its business before purchasing the
shares of Common Stock offered hereby. This Prospectus contains forward-looking
statements which involve risks and uncertainties, including but not limited to
statements concerning the commencement and completion of clinical trials, the
commencement of commercial sales of the Company's products, the timing of
planned regulatory filings, the applicability to the Company's products of drug
and cosmetic laws and regulations, the Company's intent to enter into
collaborative arrangements and the planned activities of collaborative partners,
the Company's strategic plans, the scope of the Company's patent coverage,
anticipated expenditures and the need for additional funds. Discussions
containing such forward-looking statements may be found in the material set
forth under "Risk Factors," "Management's Discussion and Analysis of Financial
Condition and Results of Operations" and "Business" as well as in the Prospectus
generally. Actual events or results may differ materially from those discussed
in this Prospectus.
History of Losses; Future Profitability Uncertain. The Company has a
history of operating losses and expects to incur substantial additional expenses
with resulting quarterly losses over at least the next several years as it
continues to develop its potential products and to devote significant resources
to preclinical studies, clinical trials and manufacturing. As of September 30,
1997, the Company had accumulated net losses of approximately $17.4 million. To
date, the Company has not sought regulatory approval to distribute any products.
The time and resource commitment required to achieve market success for any
individual product is extensive and uncertain. No assurance can be given that
the Company's product development efforts will be successful, that required
regulatory approvals can be obtained, that potential products can be
manufactured at an acceptable cost and with appropriate quality or that any
approved products can be successfully marketed.
The Company has not generated any significant revenues from product sales
or royalties from licenses of the Company's technology, and most of the
potential products that may be marketed by the Company, if any, are not expected
to be marketed or approved for marketing for at least the next several years.
Moreover, the Company anticipates that its operating expenses will continue to
increase significantly as the Company increases its research and development,
preclinical, clinical, administrative and patent activities. Accordingly, in the
absence of substantial revenues from new corporate collaborations, royalties on
product sales or other sources, the Company expects to incur substantial and
increased operating losses in the foreseeable future as certain of its earlier
stage potential products move into clinical development, as additional potential
products are selected as clinical candidates for further development, as the
Company invests in additional facilities or capacity, and as the Company invests
in research or acquires additional technologies, product candidates or
businesses. The amount of net losses and the time required to reach sustained
profitability are highly uncertain. To achieve sustained profitable operations,
the Company, alone or with its collaborative partners, must successfully
discover, develop, obtain regulatory approvals for and market its potential
pharmaceutical products. No assurances can be given that the Company will be
able to achieve or sustain profitability, and results are expected to fluctuate
from quarter to quarter.
Uncertainty of Clinical Trial Results. Before obtaining regulatory approval
for the commercial sale of many of its potential drug products, the Company must
demonstrate through preclinical studies and clinical trials that the product is
safe and efficacious for use in the clinical indication for which approval is
sought. There can be no assurance that the Company will be permitted to
undertake or continue clinical trials for any of its potential products or, if
such trials are permitted, that such products will be demonstrated to be safe
and efficacious. Moreover, the results from preclinical studies and early
clinical trials may not be predictive of results that will be obtained in
later-stage clinical trials, such as the Phase III trials being conducted by
Glaxo relating to Glylorin. Thus, there can be no assurance that the Company's
present or future clinical trials will demonstrate the safety and efficacy of
any potential products or will result in approval to market products.
The Company's most advanced topical prescription candidate, Glylorin, has
been licensed by Cellegy to Glaxo and is currently in Phase III clinical trials
in the United States. There can be no assurance that the outcome of the current
Phase III clinical trial will be favorable, that further clinical studies will
not be needed for Glylorin, that the FDA will approve Glylorin for marketing or
that current or future clinical trials of any of
6
<PAGE> 8
the Company's other product candidates will be successfully completed or lead to
FDA approval. The failure of Glylorin to successfully complete its current Phase
III or any future clinical testing, including toxicology studies, could have a
material adverse effect on the Company.
The evaluation of animal and human clinical test results involves making
judgments about data and other information that often are not conclusive. Later
testing may show those judgments to have been erroneous. For example, the
Company's beliefs regarding the potential comparative therapeutic benefits of
its products compared to currently marketed products may be erroneous, or the
FDA may not agree with the Company's conclusions regarding such matters.
Furthermore, due to the independent and blind nature of certain human clinical
testing, there will be extended periods during the testing process when the
Company will have only limited, or no, access to information about the status or
results of the tests. Other pharmaceutical companies have believed that their
products performed satisfactorily in early tests, only to find their performance
in later tests, including Phase III clinical trials, to be inadequate or
unsatisfactory, or that FDA Advisory Committees have declined to recommend
approval of the drugs, or that the FDA itself refused approval, with the result
that such companies' stock prices have fallen precipitously.
Early Stage of Product Development. With the exception of certain skin care
cosmeceutical products, Cellegy has not yet completed the development of its
proposed products or sought regulatory approval for the marketing of drug
products and has not begun to market or generate revenues from the
commercialization of products. Development of most of the Company's products
will require significant additional research and development. All of the
Company's product development efforts are based upon technologies and
therapeutic approaches that have not been widely tested or used. Moreover, the
Company's beliefs regarding the therapeutic and commercial potential for its
products are based on studies conducted to date, and later studies may not
support the Company's current beliefs. In addition, results of the Company's
studies have not been published in medical journals or reviewed by independent
third parties, and as a result have not been subjected to the same degree of
scrutiny as results that have been published or subjected to review by
independent parties.
The Company's potential products are subject to the risks of failure
inherent in the development of products based on new technologies. These risks
include the possibilities that the Company's therapeutic approaches will not be
successful; that the results from future clinical trials may not correlate with
any safety or effectiveness results from prior clinical studies conducted by the
Company or others; that some or all of the Company's potential products will not
be successfully developed or will not be found to be safe and effective by the
FDA, or otherwise will fail to meet applicable regulatory standards or receive
necessary regulatory clearances; that the products, if safe and effective, will
be difficult to manufacture in commercial quantities at reasonable costs or will
be uneconomical to market; that proprietary rights of third parties will
preclude the Company from commercializing such products; or that third parties
will market superior or equivalent products. There can be no assurance the
Company's research and development activities will result in any commercially
viable products.
Possible FDA Regulation of Cosmeceutical Products as Drugs. The Company
intends to introduce products that will compete in the cosmeceutical market.
"Cosmeceuticals" are not defined in the federal Food, Drug and Cosmetic Act (the
"FD&C Act"). The FDA has not defined the term by regulation and may consider use
of the term to imply drug-like qualities. Cosmeceuticals (a hybrid of the words
"cosmetics" and "pharmaceuticals") are products that contain active ingredients
which, when applied to the skin, will enhance appearance. Cosmeceuticals which
satisfy the definition of a cosmetic under the FD&C Act and which are not also
drugs under that statute are not subject to the same FDA requirements as drug
products. For example, cosmeceutical products that constitute cosmetics (but not
drugs as well) as defined by applicable federal laws may be marketed to
consumers without prior approval by the FDA, and without requiring a
prescription from a physician. The Company intends to develop a number of
cosmeceutical products, including a product that will compete in what is
generally referred to as the "anti-wrinkling" market.
The FDA has at times in the past contended, and may in the future contend,
that one or more cosmeceutical products, including the Company's or competitors'
anti-wrinkling products that are currently marketed or may in the future be
marketed, are not cosmetics but instead are subject to regulation as drugs.
7
<PAGE> 9
Even if the FDA were not ultimately to prevail with regard to such a contention,
such a claim by the FDA could have a material adverse effect on the Company's
ability to market its proposed cosmeceutical products and could significantly
delay or prohibit marketing of such products. The extent to which different
kinds of current or future cosmeceutical products of the Company or its
competitors are subject to FDA regulation as drugs, and the extent to which the
FDA will seek to become more active in regulating cosmeceutical products, such
as products that compete in the "anti-wrinkling" market, is uncertain, but will
depend in part on the claims made for the cosmeceuticals by their manufacturers
and marketers. See "Business -- Government Regulation." The inability of the
Company to market its proposed cosmeceutical products as cosmetics without prior
FDA approval could have a material adverse effect on the Company's business and
financial condition.
Competition and Technological Change. The pharmaceutical industry is
subject to rapid and significant technological change. In the development and
marketing of topical prescription drugs, skin care and other cosmeceutical
products and drug delivery systems, Cellegy faces intense competition.
Competitors of the Company in the United States and abroad are numerous and
include, among others, major pharmaceutical, chemical, cosmetic, consumer
product, and biotechnology companies, specialized firms, universities and other
research institutions. There can be no assurance that the Company's competitors
will not succeed in developing technologies and products that are more effective
than any which are being developed by the Company or that would render the
Company's technology and potential products obsolete and noncompetitive. Many of
these competitors have substantially greater financial and technical resources,
production and marketing capabilities and regulatory experience than the
Company. In addition, many of the Company's competitors have significantly
greater experience than the Company in preclinical testing and human clinical
trials of pharmaceutical products and in obtaining FDA and other regulatory
approvals of products for use in health care. There can be no assurance that the
Company's products under development will be able to compete successfully with
existing products or products under development by other companies, universities
and other institutions or that they will obtain regulatory approval in the
United States or elsewhere. The Company also competes with universities
developing drug delivery technologies and with several companies which have been
formed to develop unique delivery systems. In addition, these companies and
academic and research institutions compete with Cellegy in recruiting and
retaining highly qualified scientific and management personnel.
Patents and Proprietary Technology. The Company's success depends, in part,
on its ability to obtain patent protection for its products and methods, both in
the United States and in other countries. Several of the Company's products are
based on existing compounds with a history of use in humans but which are being
developed by the Company for new therapeutic use in skin diseases unrelated to
the systemic diseases for which the compounds were previously approved. The
Company cannot obtain composition patent claims on the compound itself, and will
instead need to rely on patent claims, if any, directed to use of the compound
to treat certain conditions or to specific formulations. The Company may not be
able to prevent a competitor from using that formulation or compound for a
different purpose. No assurance can be given that any additional patents will be
issued to the Company, that the protection of any patents issued in the future
will be significant or that current or future patents will be held valid if
subsequently challenged.
The patent position of companies engaged in businesses such as the
Company's business generally is uncertain and involves complex legal and factual
questions. There is a substantial backlog of patent applications at the United
States Patent and Trademark Office ( "USPTO"). Further, issued patents can later
be held invalid by the patent office issuing the patent or by a court. There can
be no assurance that any patent applications relating to the Company's products
or methods will issue as patents, or, if issued, that the patents will not be
challenged, invalidated or circumvented or that the rights granted thereunder
will provide a competitive advantage to the Company. In addition, many other
entities are engaged in research and product development efforts in drug
delivery, skin biology and cosmeceutical fields that may overlap with the
Company's currently anticipated and future products, and such other entities may
currently have, or may obtain in the future, legally blocking proprietary
rights, including patent rights, in one or more products or methods under
development or consideration by the Company. These rights may prevent the
Company from commercializing technology, or may require the Company to obtain a
license from the entity to practice the technology. There can be no assurance
that the Company will be able to obtain any such licenses that may be
8
<PAGE> 10
required on commercially reasonable terms, if at all, or that the patents
underlying any such licenses will be valid or enforceable. Moreover, the laws of
certain foreign countries do not protect intellectual property rights relating
to United States patents as extensively as those rights are protected in the
United States. As with other companies in the pharmaceutical industry, the
Company is subject to the risk that persons located in such countries will
engage in development, marketing or sales activities of products that would
infringe the Company's patent rights if such activities were in the United
States.
The agreements with the University of California pursuant to which the
Company has exclusive license rights to certain drug delivery and other
technology contain certain development and performance milestones which the
Company must satisfy in order to retain such rights. While the Company currently
believes it will be able to satisfy the milestone dates, a loss of rights to
these technologies could have a material adverse effect on the Company.
Dependence on Collaborative Partners. In view of the early stage of the
Company and its research and development programs, the Company has restricted
hiring to research and development scientists and a small administrative staff
and has made limited or no investment in marketing, product sales and regulatory
compliance resources. The Company has granted to Glaxo certain exclusive rights
to commercialize Glylorin for the indications covered by the Company's agreement
with Glaxo, and may in the future enter into agreements with certain of its
collaborative partners granting similar rights with respect to other products.
The Company has other collaborative agreements with certain third party
companies or academic institutions, and intends to enter into other
collaborative agreements in the future, relating to the research, development,
manufacture and marketing of certain potential products. In some cases, the
Company is relying, and in the future will rely, on its collaborative partners
to conduct clinical trials, to compile and analyze the data received from such
trials, to obtain regulatory approvals and, if approved, to manufacture and
market these products. As a result, the Company may have little or no control
over the development of these potential products and little or no opportunity to
review clinical data before or after public announcement. There can be no
assurance that the Company will be able to establish any such collaborative
arrangements or that they will be successful. Failure to enter into any such
arrangements that in the future might be necessary could have a material adverse
effect on the Company's business and financial condition.
Government Regulation and Product Approvals. The research, development,
testing, manufacture, labeling, distribution, marketing and advertising of
products such as the Company's products and its ongoing research and development
activities are subject to extensive regulation by governmental regulatory
authorities in the United States and other countries. The extensive preclinical
and clinical testing requirements and regulatory approval process of the FDA in
the United States and of certain foreign regulatory authorities require a number
of years and the expenditure of substantial resources. There can be no assurance
that the Company will be able to obtain the necessary approvals for clinical
testing or for the marketing of products on a timely basis or at all. Moreover,
additional government regulations may be established that could prevent or delay
regulatory approval of the Company's products. Delays in obtaining regulatory
approvals could have a material adverse effect on the Company's business and
results of operations. Even if regulatory approval of a product is granted, such
approval may include significant limitations on the indicated uses of the
product or the manner in which or conditions under which the product may be
marketed. For example, even if the Company seeks FDA approval of a product for
non-prescription consumer sales, the FDA could instead require that the product
be distributed by means of a prescription before considering approval for
distribution as a non-prescription product. Prescription only approval, which
the Company believes is common where a company seeks approval for a product
involving a new compound or a compound previously approved for other uses, could
delay for several years, or indefinitely, distribution through the
non-prescription channel of the Company's products which are subject to
premarket review and approval by the FDA. Moreover, failure to comply with
regulatory requirements for marketing drugs, or if the Company's cosmeceutical
products are deemed to be drugs by the FDA, could subject the Company to
regulatory or judicial enforcement actions, including, but not limited to,
product recalls or seizures, injunctions against production, distribution, sales
and marketing, civil penalties, criminal prosecution of the Company, its
officers or employees, refusals to approve new products and suspensions and
withdrawals of existing approvals, as well as potentially enhanced product
liability exposure. Sales of the Company's products outside the United States
will be subject to regulatory
9
<PAGE> 11
requirements governing clinical trials and marketing approval. These
requirements vary widely from country to country and could delay introduction of
the Company's products in those countries. See "Business -- Government
Regulation."
Limited Experience with Clinical Trials. The Company has conducted only a
limited number of clinical trials to date. There can be no assurance that the
Company will be able to successfully commence and complete all of its planned
clinical trials without significant additional resources and expertise. In
addition, there can be no assurance that the Company will meet its contemplated
development schedule for any of its potential products. The inability of the
Company or its existing or any future collaborative partners to commence or
continue clinical trials as currently planned, to complete the clinical trials
on a timely basis or to demonstrate the safety and efficacy or its potential
products, would have a material adverse effect on the business and the financial
condition of the Company.
Future Capital Needs; Uncertainty of Additional Funding. The Company's
operations to date have consumed substantial amounts of cash. The Company's cash
needs are expected to continue to increase significantly over at least the next
several years in order to fund the additional expenses the Company will incur as
it expands its current research and development programs, particularly in the
drug delivery, prescription pharmaceutical and cosmeceutical product areas. The
Company has no current source of significant ongoing revenues or capital beyond
existing cash, the net proceeds of this Offering and payments, if any, that may
be received pursuant to the existing licensing agreements with Glaxo. In order
to complete the research and development and other activities necessary to
commercialize its products, additional financing may be required. The Company's
future expenditures and capital requirements depend on numerous factors,
including without limitation the progress of its research and development
programs, the progress of preclinical and clinical testing, the time and costs
involved in obtaining regulatory approvals and complying with pre- and
post-regulatory approval requirements, the costs of filing, prosecuting,
defending and enforcing any patent claims and other intellectual property
rights, competing technological and market developments, changes in the
Company's existing research relationships, the ability of the Company to
establish collaborative arrangements, the development of commercialization
activities and arrangements, the purchase of capital equipment and any funding
that may be received from third parties pursuant to license, development or
other agreements that the Company may enter into in the future and the level of
royalties or revenues, if any, from commercial product sales.
As a result, the Company may seek private or public equity investments and
future collaborative arrangements with third parties to help fund its future
cash needs. There is no assurance that such funding will be available on
acceptable terms, if at all. Insufficient funding may require the Company to
delay, reduce or eliminate some or all of its research and development
activities, planned clinical trials and administrative programs. The Company
believes that available cash resources, the net proceeds of this Offering and
the interest thereon will be adequate to satisfy its capital needs through at
least December 31, 1999. See "Management's Discussion and Analysis of Financial
Condition and Results of Operations."
Limited Sales and Marketing Experience. The Company may market certain of
its products, if successfully developed and approved, through a direct sales
force in the United States and through sales and marketing partnership
arrangements or distribution arrangements outside the United States. The Company
has no history or experience in sales, marketing or distribution. To market its
products directly, the Company must either establish a marketing group and
direct sales force or obtain the assistance of one or more third parties. There
can be no assurance that the Company will be able to establish sales and
distribution capabilities or succeed in gaining market acceptance for its
products. If the Company enters into marketing or licensing arrangements with
established pharmaceutical companies, the Company's revenues will be subject to
the payment provisions of such arrangements and will be dependent on the efforts
of third parties. There can be no assurance that the Company will be able to
successfully establish a direct sales force or that its collaborators will
effectively market any of the Company's potential products, and the inability of
the Company or its collaborators to do so could have a material adverse effect
on the business and financial condition of the Company.
10
<PAGE> 12
Manufacturing Limitations; Suppliers. The Company has no experience in
manufacturing commercial quantities of its potential products and currently does
not have any capacity to manufacture potential products on a commercial scale
itself. The Company currently relies on a third party to manufacture unprocessed
compounds into therapeutic products. Although the Company believes that there
will be adequate third party manufacturers, there can be no assurance that the
Company will be able to enter into acceptable agreements with third party
manufacturers, and the Company is and will be dependent upon third party
contract manufacturers for such production. There can be no assurance that the
Company will continue to be able to obtain contract manufacturing on
commercially acceptable terms for compounds or products and quantities currently
obtainable. There can be no assurance that manufacturing or quality control
problems will not arise at the manufacturing plants of the Company's contract
manufacturers or that such manufacturers will be able to maintain the compliance
with the FDA's current good manufacturing practice requirements necessary to
continue manufacturing the Company's products.
Broad Management Discretion Over Use of Proceeds. The primary purposes of
the Offering are to increase the Company's working capital and funds available
for general corporate purposes, preclinical and clinical development, research
activities, including investigation of new technologies and potential
acquisition of complementary technologies, product candidates or businesses. The
Company has not designated specific amounts of the net proceeds for particular
purposes. Management of the Company will have broad discretion with respect to
the use of proceeds derived from the Offering.
Uncertainty Related to Health Care Industry. The health care industry is
subject to changing political, economic and regulatory influences that may
significantly affect the purchasing practices and pricing of human therapeutics.
Cost containment measures, whether instituted by health care providers or
enacted as a result of government health administration regulators or new
regulations, such as pricing limitations or formulating eligibility for
dispensation by medical providers, could result in greater selectivity in the
availability of treatments. Such selectivity could have an adverse effect on the
Company's ability to sell its prescription products and there can be no
assurance that adequate third party coverage will be available for the Company
to maintain price levels sufficient to generate an appropriate return on its
investment in product development. Third-party payors are increasingly focusing
on the cost-benefit profile of alternative therapies and prescription drugs and
challenging the prices charged for such products and services. Also, the trend
towards managed health care in the United States and the concurrent growth of
organizations such as health maintenance organizations which could control or
significantly influence the purchase of health care services and products, as
well as legislative proposals to reform health care or reduce government
insurance programs, may all result in lower prices or proposals to reform health
care or reduce government insurance programs or result in lower prices or
reduced markets for the Company's products. The cost containment measures and
reforms that government institutions and third party payors are considering
instituting could result in significant and unpredictable changes to the
marketing, pricing and reimbursement practices of prescription drugs marketed by
bio-pharmaceutical companies such as the Company. The adoption of any such
measures or reforms could have a material adverse effect on the business and
financial condition of the Company. However, cosmeceutical products generally
are not reimbursed by third party payors.
Dependence Upon Key Employees. The success of the Company is dependent upon
the efforts of its senior management team, including Dr. Carl R. Thornfeldt,
Chairman of the Board of Directors and Medical Director of the Company, and K.
Michael Forrest, Chief Executive Officer of the Company. A change in the
association of these individuals or other officers and directors of the Company
could adversely affect the Company if suitable replacement personnel could not
be employed. The success of the Company also depends upon its ability to
continue to attract and retain qualified scientific and technical personnel.
There is intense competition for qualified personnel in the areas of the
Company's activities, and there can be no assurance that the Company will be
able to continue to attract and retain the qualified personnel necessary for the
development or expansion of its business.
Environmental Regulation. The Company is subject to federal, state and
local laws and regulations governing the use, generation, manufacture, storage,
discharge, handling and disposal of certain materials and wastes used in its
operations, some of which are classified as "hazardous." There can be no
assurance that the Company will not be required to incur significant costs to
comply with environmental laws, the Occupational
11
<PAGE> 13
Safety and Health Act, and state, local and foreign counterparts to such laws,
rules and regulations as its activities are increased or that the operations,
business and future profitability of the Company will not be adversely affected
by current or future laws, rules and regulations. The risk of accidental
contamination or injury from hazardous materials cannot be eliminated. In the
event of such an accident, the Company could be held liable for any damages that
result and any such liability could exceed the resources of the Company. In any
event, the cost of defending claims arising from such contamination or injury
could be substantial. In addition, the Company cannot predict the extent of the
adverse effect on its business or the financial and other costs that might
result from any new government requirements arising out of future legislative,
administrative or judicial actions.
Risk of Product Liability; Limited Product Liability Insurance. The
testing, marketing and sale of human health care products entails an inherent
risk of allegations of product liability. There can be no assurance that
substantial product liability claims will not be asserted against the Company.
The Company has obtained limited amounts of insurance relating to its clinical
trials. There can be no assurance that the Company will be able to obtain or
maintain insurance on acceptable terms for its clinical and commercial
activities or that any insurance obtained will provide adequate protection
against potential liabilities.
Anti-Takeover Provisions. Certain provisions of the Company's Amended and
Restated Articles of Incorporation, as well as the California General
Corporation Law, could discourage a third party from attempting to acquire, or
make it more difficult for a third party to acquire, control of the Company
without approval of the Company's Board of Directors. Such provisions could also
limit the price that certain investors might be willing to pay in the future for
shares of the Common Stock. Certain of such provisions allow the Board of
Directors to authorize the issuance of preferred stock with rights superior to
those of the Common Stock. The rights of the holders of Common Stock will be
subject to, and may be adversely affected by, the rights of the holders of any
preferred stock that may be issued in the future. The issuance of preferred
stock could adversely affect the voting power of holders of Common Stock and the
likelihood that such holders will receive dividend payments and payments upon
liquidation. The Company has no current plans to issue shares of preferred
stock. The Company is also subject to the provisions of Section 1203 of the
California General Corporation Law which requires that a fairness opinion be
provided to the Company's shareholders in connection with their consideration of
any proposed "interested party" reorganization transaction.
Volatility of Stock Price. The stock market has from time to time
experienced significant price and volume fluctuations that may be unrelated to
the operating performance of particular companies. In addition, the market price
of the Common Stock, like the stock prices of many publicly-traded
pharmaceutical, chemical, consumer, and biotechnology companies, may prove to be
highly volatile. Announcements of technological innovations or new commercial
products by the Company or its competitors, developments or disputes concerning
patent or proprietary rights, publicity regarding actual or potential medical
results relating to products under development by the Company or its
competitors, regulatory developments in both the United States and foreign
countries, public concern as to the safety of pharmaceutical products, sales of
a large number of shares of Common Stock in the market and economic and other
external factors, as well as period-to-period fluctuations in financial results,
among other factors, may have a significant impact on the market price of the
Common Stock.
12
<PAGE> 14
USE OF PROCEEDS
The net proceeds to be received by the Company from the sale of the
2,250,000 shares of Common Stock offered hereby are estimated to be
approximately $17.5 million (approximately $20.2 million if the Underwriter's
overallotment option is exercised in full), at an assumed public offering price
of $8.50 per share and after deducting estimated underwriting discounts and
commissions and estimated offering expenses.
The Company intends to use a substantial portion of the net proceeds to
conduct clinical trials and fund its research and development programs and
research facilities and for general corporate purposes, including working
capital. Although Cellegy is focusing primarily on the development of its own
products, a portion of the net proceeds may also be used to acquire products,
technologies or businesses consistent with its commercial objectives. The
Company is not currently a party to any agreements with respect to such
acquisitions or investments.
The amounts and timing of expenditures for each purpose may vary
significantly depending on numerous factors including, without limitation, the
progress of the Company's research and development programs, the progress and
results of the Company's clinical trials and preclinical studies, the time and
costs involved in obtaining regulatory approvals, the costs of filing,
prosecuting, defending and enforcing any patent claims and other intellectual
property rights, competing technological and market developments, changes in the
Company's existing research relationships, the ability of the Company to
establish collaborative arrangements, the initiation of commercialization
activities, the purchase of capital equipment and the availability of other
financing. The Company believes that its available cash resources, the net
proceeds from this offering and the interest thereon will be adequate to satisfy
its capital needs at least through December 31, 1999.
Pending such uses, the net proceeds of this Offering will be invested in
short-term, interest-bearing, investment grade securities.
PRICE RANGE OF COMMON STOCK
Cellegy's Common Stock has been traded on the Nasdaq SmallCap Market under
the symbol "CLGY" since the Company's initial public offering in August 1995.
The Company has applied to have its Common Stock approved for quotation on the
Nasdaq National Market under the symbol "CLGY." The following table sets forth
the range of high and low sale prices for the Common Stock as reported on the
Nasdaq SmallCap Market for the periods indicated below.
<TABLE>
<CAPTION>
1995 HIGH LOW
- ----------------------------------------------------------------------------- ----- -----
<S> <C> <C>
Third Quarter................................................................ $7.25 $4.88
Fourth Quarter............................................................... 6.25 4.00
1996
- -----------------------------------------------------------------------------
First Quarter................................................................ 7.13 5.00
Second Quarter............................................................... 10.13 5.50
Third Quarter................................................................ 9.38 4.75
Fourth Quarter............................................................... 6.00 4.38
1997
- -----------------------------------------------------------------------------
First Quarter................................................................ 5.13 4.13
Second Quarter............................................................... 4.50 2.38
Third Quarter................................................................ 6.56 2.44
Fourth Quarter (through October 16, 1997).................................... 9.44 6.31
</TABLE>
As of October 10, 1997, there were approximately 96 shareholders of record.
The Company believes that the actual number of shareholders of the Common Stock
substantially exceeds this number.
13
<PAGE> 15
CAPITALIZATION
The following table sets forth the actual capitalization of the Company as
of September 30, 1997, and as adjusted to reflect the sale of the 2,250,000
shares of Common Stock offered hereby at an assumed offering price of $8.50 per
share, and the receipt of the estimated net proceeds therefrom.
<TABLE>
<CAPTION>
SEPTEMBER 30, 1997
------------------------
ACTUAL AS ADJUSTED
-------- -----------
(IN THOUSANDS)
<S> <C> <C>
Shareholders' equity:
Preferred Stock, no par value: 5,000,000 shares authorized; no
shares issued and outstanding.................................... $ -- $ --
Common Stock, no par value: 20,000,000 shares authorized; 7,594,959
shares issued and outstanding actual, 9,844,959 shares issued and
outstanding as adjusted(1)....................................... 26,497 44,009
Unrealized gain on investments...................................... 48 48
Deficit accumulated during the development stage.................... (17,431) (17,431)
--------
Total shareholders' equity..................................... 9,114 26,626
-------- --------
Total capitalization........................................ $ 9,114 $ 26,626
======== ========
</TABLE>
- ---------------
(1) Based on the number of shares outstanding as of September 30, 1997. Excludes
1,061,447 shares of Common Stock issuable upon the exercise of outstanding
stock options at a weighted average exercise price of $4.19 per share,
661,250 shares of Common Stock issuable upon the exercise of the IPO
Warrants at an exercise price of $9.375 per share, 832,061 other shares of
Common Stock issuable upon the exercise of other outstanding warrants at a
weighted average exercise price of $7.79 per share, and up to 125,000 shares
of Common Stock issuable upon the exercise of the Underwriter Warrant. See
"Description of Capital Stock."
DIVIDEND POLICY
The Company has never paid dividends on its Common Stock and does not
anticipate paying dividends on its Common Stock in the foreseeable future.
14
<PAGE> 16
DILUTION
As of September 30, 1997, the net tangible book value of the Company's
Common Stock was $9,114,000 or $1.20 per share of Common Stock. "Net tangible
book value" per share represents the amount of total tangible assets of the
Company reduced by the total liabilities and divided by the number of shares of
Common Stock outstanding. After giving effect to the sale by the Company of
2,250,000 shares of Common Stock offered hereby, less underwriting discount and
estimated offering expenses payable by the Company, the Company's pro forma net
tangible book value as of September 30, 1997 would have been $26,626,000, or
$2.70 per share of Common Stock. This represents an immediate increase in pro
forma net tangible book value of $1.50 per share to existing holders of Common
Stock and an immediate dilution per share of $5.80 to new investors purchasing
shares of Common Stock in this Offering. "Dilution per share to new investors"
represents the difference between the price per share of Common Stock paid for
the shares issued in this Offering and the pro forma net tangible book value per
share at September 30, 1997, as adjusted to give effect to this Offering.
<TABLE>
<S> <C> <C>
Public offering price per share(1)........................... $8.50
Pro forma net tangible book value per share before
offering................................................ $1.20
Increase per share attributable to new investors........... 1.50
-----
Pro forma net tangible book value per share after offering... 2.70
-----
5.80
Dilution per share to new investors................ =====
</TABLE>
- ---------------
(1) Before deduction of underwriting discount and estimated offering expenses
payable by the Company.
The above computations assume no exercise of outstanding options and
warrants. At September 30, 1997, a total of 1,061,447 shares of Common Stock
were subject to outstanding options at a weighted average exercise price of
$4.19 per share, 661,250 shares of Common Stock issuable upon the exercise of
the IPO Warrants at an exercise price of $9.375 per share, 832,061 other shares
of Common Stock issuable upon the exercise of other outstanding warrants at a
weighted average exercise price of $7.79 per share and up to 125,000 shares of
Common Stock issuable upon the exercise of the Underwriter Warrant. Any exercise
of such options or warrants may result in further dilution to new investors.
15
<PAGE> 17
SELECTED FINANCIAL DATA
The following balance sheet data as of December 31, 1995 and 1996 and the
statement of operations data for the three years ended December 31, 1996 are
derived from the Company's audited financial statements that are included
elsewhere in this Prospectus. The balance sheet data set forth below as of
December 31, 1992, 1993 and 1994 and the statement of operations data for the
years ended December 31, 1992 and 1993, are derived from the Company's audited
financial statements which are not included herein. The balance sheet data at
September 30, 1997 and the statement of operations data for the nine months
ended September 30, 1996 and 1997, are derived from the Company's unaudited
financial statements. In the opinion of management of the Company, the unaudited
financial statements have been prepared on the same basis as the audited
financial statements and include all adjustments, consisting only of normal
recurring adjustments, necessary for a fair presentation of the Company's
financial position and results of operations for these periods. Operating
results for the nine months ended September 30, 1997 are not necessarily
indicative of the results that may be expected for the entire year ending
December 31, 1997. The data set forth below should be read in conjunction with
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" and the Financial Statements.
<TABLE>
<CAPTION>
PERIOD FROM
NINE MONTHS ENDED JUNE 26, 1989
(INCEPTION)
YEARS ENDED DECEMBER 31, SEPTEMBER 30, THROUGH
----------------------------------------------- ----------------- SEPTEMBER 30,
1992 1993 1994 1995 1996 1996 1997 1997
------- ------- ------- ------- ------- ------- ------- --------------
(IN THOUSANDS, EXCEPT PER SHARE DATA)
<S> <C> <C> <C> <C> <C> <C> <C> <C>
STATEMENT OF OPERATIONS DATA:
Revenues................................. $ 44 $ 86 $ -- $ 1,000 $ 648 $ 15 $ 643 $ 2,422
Expenses:
Research and development............... 828 1,798 1,510 1,225 2,712 1,866 2,389 11,511
General and administrative............. 1,069 723 1,032 1,310 1,634 1,171 1,066 7,248
------- ------- ------- ------- ------- ------- ------- --------------
Total expenses................... 1,897 2,521 2,542 2,535 4,346 3,037 3,455 18,759
Loss from operations..................... (1,853) (2,435) (2,542) (1,535) (3,698) (3,022) (2,812) (16,337)
Interest expense....................... -- -- (5) (752) -- -- -- (864)
Interest income and other, net......... 178 156 4 135 330 271 354 1,219
------- ------- ------- ------- ------- ------- ------- --------------
Net loss................................. (1,675) (2,279) (2,543) (2,152) (3,368) (2,751) (2,458) (15,982)
Non-cash preferred dividends............. -- -- -- -- 1,414 1,368 35 1,449
------- ------- ------- ------- ------- ------- ------- --------------
Net loss applicable to common
shareholders........................... $(1,675) $(2,279) $(2,543) $(2,152) $(4,782) $(4,119) $(2,493) $(17,431)
======= ======= ======= ======= ======= ======= ======= =============
Pro forma net loss per share(1).......... $ (0.76) $ (0.67) $ (1.11) $ (1.02) $ (0.41)
======= ======= ======= ======= =======
Shares used in computing pro forma net
loss per share(1)...................... 3,344 3,206 4,307 4,050 6,076
</TABLE>
<TABLE>
<CAPTION>
DECEMBER 31,
----------------------------------------------- SEPTEMBER 30,
1992 1993 1994 1995 1996 1997
------- ------- ------- ------- ------- -------------
(IN THOUSANDS)
<S> <C> <C> <C> <C> <C> <C>
BALANCE SHEET DATA:
Cash, cash equivalents and investments.................... $ 3,276 $ 1,099 $ 402 $ 3,820 $ 7,315 $ 9,377
Total assets.............................................. 3,558 1,280 555 4,028 7,696 9,841
Deficit accumulated during the development stage.......... (3,181) (5,460) (8,004) (10,155) (14,937) (17,431)
Total shareholders' equity (deficit)...................... 3,325 1,168 (1,374) 3,648 7,387 9,114
</TABLE>
- ---------------
(1) See Note 1 of Notes to the Financial Statements for an explanation of the
determination of the number of pro forma shares used in per share
calculations.
16
<PAGE> 18
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
This Prospectus contains forward-looking statements which involve risks and
uncertainties, including but not limited to statements concerning the
commencement and completion of clinical trials, the timing of planned regulatory
filings, the applicability of drug and cosmetic laws and regulations to the
Company's products, planned activities of collaborative partners, the Company's
strategic plans, the scope of the Company's patent coverage, anticipated
expenditures and the need for additional funds. Discussions containing such
forward-looking statements may be found in the material set forth under "Risk
Factors" and "Business" as well as in the Prospectus generally. Actual events or
results may differ materially from those discussed in this Prospectus.
Cellegy is a biopharmaceutical company engaged in the development of
prescription drugs and cosmeceuticals to address a variety of diseases and
conditions utilizing its patented transdermal and topical delivery technologies.
Cellegy's first prescription drug, Glylorin, is a novel treatment for certain
forms of ichthyosis, a family of incurable skin diseases. Glylorin has been
licensed by Cellegy to Glaxo and is currently in Phase III clinical trials in
the United States. Cellegy is also evaluating several prescription drugs
including a transdermal testosterone gel for the treatment of hypogonadism, a
condition that frequently results in lethargy and reduced libido in men above
the age of 40. In addition to its prescription drugs, Cellegy is testing and
developing a line of anti-wrinkling cosmeceutical products which the Company
believes will address the skin care needs of an affluent and aging population.
Since its inception in 1989, the Company has engaged only in research and
development activities, and intends to continue research, development and
testing of its drug delivery systems and pharmaceutical and cosmeceutical
products.
In July 1997, the Company reacquired rights to skin repair technology that
had been licensed in April 1992 to Neutrogena Corporation ("Neutrogena"), a
subsidiary of Johnson & Johnson. Pursuant to this licensing agreement, Cellegy
has received development funding and other amounts from Neutrogena over the last
several years. The Company will not receive additional development funding under
this agreement.
In November 1996, the Company entered into a licensing agreement with Glaxo
for Cellegy's most advanced topical prescription drug candidate, Glylorin. The
license agreement provides for milestone payments, certain development funding
and royalty payments on net sales assuming successful completion of product
development and market launch.
In September 1996, the Company received an Orphan Drug grant from the FDA
to cover certain of the Company's Phase III study costs for Glylorin over a two
year period.
RESULTS OF OPERATIONS
NINE MONTHS ENDED SEPTEMBER 30, 1997 AND 1996
Revenues. The Company had revenues of $643,000 for the nine months ended
September 30, 1997, compared with revenues of $15,000 for the same period last
year. Revenues for the nine months ended September 30, 1997, consisted of
$442,000 for development funding associated with the Glaxo license agreement,
$126,000 from an FDA Orphan Drug grant relating to Glylorin and $75,000 from
Neutrogena for the reimbursement of patent expenses incurred by Cellegy related
to a license agreement with Neutrogena. Revenues of $15,000 for the nine months
ended September 30, 1996, were associated with the Neutrogena licensing
agreement. The Company expects to receive additional development funding and
milestones from Glaxo over the next several quarters and is pursuing other
licensing and product supply agreements which, if entered into, may result in
additional contract revenues or product sales. There can be no assurances
regarding when, or if, such revenues will occur.
17
<PAGE> 19
Research and Development Expenses. Research and development expenses were
$2,389,000 for the nine months ended September 30, 1997, compared with
$1,866,000 for the same period last year. This increase was primarily due to
salary costs associated with the addition of scientific personnel, as well as
increased contract research expenses. Cellegy's research expenses are expected
to increase during the fourth quarter of 1997 and throughout 1998 as preclinical
and clinical trial activity associated with its testosterone and anti-wrinkling
programs increases and as it continues to focus on the identification and
testing of compounds using the Company's drug delivery technologies. The Company
plans to selectively add personnel in research and development in order to
accomplish its goals.
General and Administrative Expenses. General and administrative expenses
were $1,066,000 for the nine months ended September 30, 1997, compared with
$1,171,000 for the same period last year. Higher expenses during the 1996 period
resulted primarily from administrative costs associated with a Series A
Preferred Stock financing and subsequent preparation and filing of registration
statements. The Company's general and administrative expenses are expected to
increase in the future in support of its research and product commercialization
efforts. However, the rate of increase in general and administrative expenses is
expected to be lower than the growth rate of research and development spending.
Interest Income and Expense. Interest income was $354,000 for the nine
months ended September 30, 1997, compared with $271,000 for the same period last
year. The additional interest income earned during 1997 was due to higher
average investment balances during that period.
Net Loss. The net loss applicable to common shareholders was $2,493,000 or
$0.41 per share for the nine months ended September 30, 1997, compared with
$4,119,000 or $1.02 per share for the same period last year. The Company's net
loss during 1996 was impacted by significant non-cash preferred dividend charges
reflecting primarily a 15% discount to the common stock variable conversion
price of the Series A Preferred Stock issued in April 1996. The impact of these
dividends was $35,000 and $1,368,000, for the nine months ended September 30,
1997 and 1996, respectively.
YEARS ENDED DECEMBER 31, 1996, 1995 AND 1994
Revenues. The Company had revenues of $648,000 and $1,000,000 in 1996 and
1995, respectively. No revenues were recorded for 1994. In 1996, revenues
consisted primarily of approximately $560,000 associated with the Glaxo license
agreement and approximately $74,000 from FDA Orphan Drug grant payments.
Revenues in 1995 of $1,000,000 were associated with the expiration in May 1995
of Cellegy's option to reacquire rights to a prescription product that was
originally purchased by Neutrogena in 1994.
Research and Development Expenses. Research and development expenses were
$2,712,000 in 1996, compared with $1,225,000 in 1995 and $1,510,000 in 1994. The
increase of $1,487,000 in 1996 was primarily due to clinical trial expenses
related to Glylorin. Other factors contributing to the increase in expenses were
personnel costs associated with the hiring of additional scientists, and costs
of contract research work related to the Company's drug delivery technology.
Additionally, the Company occupied and equipped a new laboratory in San Carlos,
California during the first half of 1996. The decrease of $285,000 in 1995 was
primarily due to a reduction in formulation activity associated with products
entering the clinical phase.
Although the Company's expenses related to Glylorin are expected to
decrease significantly as Glaxo is obligated to pay for product development
costs under the Company's agreement with Glaxo, Cellegy's total research
expenses are expected to increase in the future as preclinical and clinical
trial activity associated with other research programs increase. The Company has
increased its research spending in 1997 and expects to increase its research
spending again during 1998 as a result of its efforts to identify, develop and
test compounds using the Company's PERMEATE and CELLEDIRM technologies.
General and Administrative Expenses. General and administrative expenses
were $1,634,000 in 1996, compared with $1,310,000 in 1995 and $1,032,000 in
1994. The increase of $324,000 in 1996 was primarily due to increased
professional fees, as well as increases in personnel and related expenses. The
increase of $278,000 in 1995 was primarily due to increased salaries. The
Company's general and administrative expenses
18
<PAGE> 20
are expected to continue to increase in the future in support of its research
and product commercialization efforts.
Interest Income and Expense. The Company recognized $330,000 in interest
income for 1996, compared with $135,000 for 1995. Interest income in 1994 was
not significant. The additional interest income earned in 1996 was due to a
higher investment balance during the 1996 period resulting from proceeds
associated with the Series A Preferred Stock financing transaction completed in
April 1996. The Company incurred no interest expense during 1996. In 1995,
interest expense was $752,000 which reflected the interest and amortization of
the discount on the notes issued in connection with a bridge financing
transaction, which were repaid in August 1995. Interest expense in 1994 was not
significant.
Net Loss. The net loss applicable to common shareholders was $4,782,000 or
$1.11 per share in 1996, compared with a net loss of $2,152,000 or $0.67 per
share in 1995 and a net loss of $2,543,000 or $0.76 per share in 1994. The net
loss applicable to common shareholders in 1996 was impacted by two significant
non-cash items. Total operating expenses in 1996 included a total of $268,000
associated with the extension of certain stock option exercise periods. In
addition, there was a non-cash preferred dividend charge of $1,414,000 due to a
one-time conversion discount of 15% and an ongoing dividend rate of 8%
associated with the issuance of Series A Preferred Stock.
LIQUIDITY AND CAPITAL RESOURCES
The Company has experienced net losses and negative cash flow from
operations each year since its inception. Through September 30, 1997, the
Company had incurred an accumulated deficit of $17.4 million and had consumed
cash from operations of $14.3 million. The Company raised approximately $6.4
million in net proceeds from its initial public offering in August 1995 and
approximately $6.8 million in net proceeds from a preferred stock financing in
April 1996. An additional approximately $3.8 million was raised in a private
placement of Common Stock in July 1997.
The Company's cash and investments were $9.4 million at September 30, 1997,
compared with $7.3 million at December 31, 1996. The increase of $2.1 million
during the first nine months of 1997 was principally due to additional funds
received in the private placement completed in July 1997, offset by net cash
used in operating activities.
The Company's operations to date have consumed substantial amounts of cash.
The Company has no current source of significant ongoing revenues or capital
beyond existing cash and investments, the net proceeds of this Offering and
payments if any, that may be received pursuant to existing licensing agreements
with third parties. In order to complete the research and development and other
activities necessary to commercialize its products, additional financing may be
required. The Company's future expenditures and capital requirements depend on
numerous factors including, without limitation, the progress and focus of its
research and development programs, the progress and results of preclinical and
clinical testing, the time and costs involved in obtaining regulatory approvals
and complying with pre- and post-approval regulatory requirements, the costs of
filing, prosecuting, defending and enforcing any patent claims and other
intellectual property rights, competing technological and market developments,
changes in the Company's existing research relationships, the ability of the
Company to establish collaborative arrangements, the initiation of
commercialization activities, the purchase of capital equipment and the
availability of other financing.
In the course of its development activities, the Company has incurred
significant losses and expects to incur substantial additional development
costs. As a result, the Company will require additional funds to finance
operations and may seek private or public equity investments and future
collaborative arrangements with third parties to meet such needs. There is no
assurance that such funding will be available for the Company to finance its
operations on acceptable terms, if at all. Insufficient funding may require the
Company to delay, reduce or eliminate some or all of its research and
development activities, planned clinical trials and administrative programs. The
Company believes that available cash resources, the net proceeds of this
Offering and the interest thereon will be adequate to satisfy its capital needs
through at least December 31, 1999.
19
<PAGE> 21
As of December 31, 1996, the Company had federal and state income tax net
operating loss carryforwards of approximately $12.8 million and $4.7 million,
respectively, which expire between 2004-2011 and 1997-2001, respectively. The
Company also had federal and state research tax credit carryforwards of
approximately $262,000 and $95,000, respectively. The federal credits expire
between 2006 and 2011; the state credits have no expiration date.
20
<PAGE> 22
BUSINESS
OVERVIEW
Cellegy is a biopharmaceutical company engaged in the development of
prescription drugs and cosmeceuticals to address a variety of diseases and
conditions utilizing its patented transdermal and topical delivery technologies.
Cellegy's first prescription drug, Glylorin, is a novel treatment for certain
forms of ichthyosis, a family of incurable skin diseases. Glylorin has been
licensed by Cellegy to Glaxo and is currently in Phase III clinical trials in
the United States. Cellegy is also evaluating several prescription drugs
including a transdermal testosterone gel for the treatment of hypogonadism, a
condition that frequently results in lethargy and reduced libido in men above
the age of 40. In addition to its prescription drugs, Cellegy is testing and
developing a line of anti-wrinkling cosmeceutical products which the Company
believes will address the skin care needs of an affluent and aging population.
The Company's principal technologies consist of PERMEATE and CELLEDIRM.
PERMEATE is a patented topical drug delivery system which has been found in
preclinical evaluations to permit delivery of larger or insoluble drugs into the
blood stream or into the skin itself. These drugs include peptides that to the
Company's knowledge are not deliverable using methods employed in currently
approved transdermal products. CELLEDIRM is a group of compounds identified by
Cellegy's scientists which have been found in preclinical evaluations to reduce
or eliminate irritation caused by many substances that come into contact with
the skin. The Company's CELLEDIRM technology is being developed as an adjunct to
the PERMEATE technology to mitigate skin irritation problems associated with
transdermal drug delivery, and to improve existing prescription drugs and
cosmeceutical products.
Glylorin, the Company's most advanced topical prescription candidate, is
currently in Phase III clinical trials for non-bullous congenital ichthyosiform
erythroderma ("n-CIE"). n-CIE is a severe form of congenital primary ichthyosis
("CPI"), a group of incurable skin conditions for which there is currently no
satisfactory treatment. Ichthyosis is a family of related skin diseases
characterized by a severe scaling of the skin that frequently affects large
areas of the body. In all forms of ichthyosis, skin cells form a rigid, thick
surface layer of scales that often discolor and crack. Many of the most severely
afflicted infants die shortly after birth from dehydration, hypothermia and
microbes, which enter through the damaged epidermis. Approximately 100,000
people in the United States, and at least an equal number of persons outside the
United States, are afflicted with CPI.
Based on Phase I and II clinical trials conducted by the Company, Glylorin
appears to be safe and effective in the treatment of n-CIE. The results from the
Company's Phase II clinical trials showed statistically significant improvements
in scaling, induration (swelling) and erythema (redness). After developing the
product through early Phase III clinical trials, Cellegy licensed Glylorin to
Glaxo in November 1996. Glaxo has completed patient enrollment for the Phase III
trial.
STRATEGY
Cellegy intends to become a leader in the field of transdermal drug
delivery and in the development and marketing of specialty pharmaceutical and
cosmeceutical products that are applied to the skin. Key elements of its
business and commercialization strategy include the following:
Lower Risk Strategy for Selecting Product Candidates for Development. The
Company does not intend to focus its product development efforts on development
of new chemical entities. Instead, the Company will focus on applying its
proprietary technologies in the following three areas:
(1) development of improved topical and transdermal formulations of
FDA approved pharmaceutical compounds for which marketing exclusivity or
patent rights have expired or are near expiration;
(2) development of topical or transdermal formulations of new
chemical entities in partnership with innovator pharmaceutical or
biotechnology companies; and
21
<PAGE> 23
(3) development of new, high performance cosmeceutical products
that address the skin care needs of an increasing number of affluent
middle-aged and older people.
Leveraging of Corporate Alliances. Cellegy plans to enter into strategic
alliances with established pharmaceutical companies for the development of
certain products. These alliances generally will provide research or clinical
funding and other support during the product development process. Cellegy's
partners generally will provide established and trained marketing and sales
forces to sell the products.
Internal Focus on the Dermatology Market. Cellegy plans to retain exclusive
or co-marketing/co-promotion rights in the United States to dermatological and
related uses of the products it develops, while out-licensing rights for other
uses. Similarly, whenever possible, it will attempt to retain commercial rights
to dermatological and other specialty pharmaceutical uses of products developed
under partner sponsored research collaborations. The Company ultimately plans to
market the dermatologic and cosmeceutical products it develops, either through
the utilization of contract sales representatives or through the establishment
of its own sales force.
Acquisition of Complementary Products, Technologies or Businesses. Although
Cellegy is focusing primarily on the development of its own products and
technologies, the Company may opportunistically acquire products, technologies
or companies with products and distribution capabilities consistent with its
commercial objectives.
BACKGROUND
Skin Biology
Cellegy's technologies and products have been developed based on an expert
knowledge of the biology and physical function of the skin, particularly the
epidermis. The epidermis is comprised mainly of cells known as keratinocytes
which are continually regenerated and move toward the skin surface where they
flatten, loose their nucleus and become the outermost layer of the epidermis,
the stratum corneum. The stratum corneum acts as a protective barrier against
physical injuries and disease, and regulates the loss of moisture from the body.
It consists of an array of flattened cells suspended in highly organized lipid
structures, similar conceptually to a brick and mortar arrangement. Most
importantly, these lipids regulate the permeability properties of the skin and,
therefore, the movement of topically applied drugs into the body.
(Figure depicts the epidermis showing the various layers thereof, including the
stratum corneum.)
In addition to its physical role as barrier, the epidermis is biologically
active, capable of initiating a full inflammatory reaction (characterized by
redness and swelling). Normally, this process is a protective reaction in
response to various noxious stimuli such as sunlight, poison ivy or cuts and
bruises. The same reaction, however, can result following the topical
application of many drugs.
22
<PAGE> 24
Similarly, certain dermatologic diseases can also be linked to
environmental influences. Psoriasis, for example, which is characterized by
inflammation and accelerated growth of the epidermis, can sometimes be triggered
by a simple cut or abrasion to the skin. Nonetheless, despite material
differences in appearance and symptoms, this disease and the other inflammatory
reactions described above all share fundamental similarities in the underlying
biological processes mediated by the epidermis.
Transdermal Drug Delivery
Transdermal delivery involves the topical administration of drugs to the
skin for the treatment of systemic diseases or localized skin conditions,
generally using patches. This method of drug delivery is well suited for drugs
that are targeted to the skin itself, or for drugs that are degraded either in
the intestinal tract or the liver if taken orally, such that only a small
fraction of the total administered dose is actually absorbed into the
bloodstream. Attempts to overcome this problem by increasing the dosage can
result in harmful side effects.
Transdermal delivery systems may offer significant advantages over many
conventional oral dosage forms and most parenteral (injectable) dosage forms.
Those advantages include increased convenience, less pain (compared to
injections), improved patient compliance and potentially reduced side effects.
Transdermal delivery systems can also offer certain advantages to pharmaceutical
companies, including brand extension, further product differentiation and
additional patent protection.
Transdermal delivery has historically been limited to those drugs which are
small in size, highly potent and can easily penetrate the skin due to their
physical and chemical characteristics. Specifically, the Company believes that
drugs with molecular weights larger than 400, or drugs that require daily doses
greater than five milligrams or that are too lipid soluble, will be difficult to
deliver transdermally. Although many companies have experimented with different
methods of facilitating the delivery of drugs through the skin barrier, to date
they have enjoyed only limited success. Of all the prescription drugs in the
United States, less than ten systemically-active drugs are currently approved by
the FDA for transdermal administration. Although this reflects a reasonably
successful history relative to other non-oral routes of novel drug
administration (for example, nasal, implants or liposomal-based systems),
transdermal delivery has proved more difficult than initially anticipated.
There are many reasons for the limited number of transdermal product
offerings. The principal reason relates to irritation caused by solvents and
other conventional permeation enhancers designed to ease the passage of drugs
through the skin. These solvents dissolve the lipid-rich stratum corneum,
permitting the passage of the therapeutic agent into the lower levels of the
skin, where it can be absorbed into the bloodstream. However, the interaction of
the solvents with the metabolically active stratum corneum and the resulting
inflammatory responses have been greater than anticipated. Several of the
currently marketed transdermal patches utilize these solvents, often in
concentrations exceeding the drug itself. The table below summarizes the
incidence of skin irritation, as determined in certain clinical studies,
associated with certain FDA approved transdermal products.
<TABLE>
<CAPTION>
INCIDENCE OF ADVERSE
TRANSDERMAL DRUG SKIN REACTIONS* PRINCIPAL SKIN REACTIONS
- ---------------- -------------------- ---------------------------------
<S> <C> <C>
Scopolamine 10% Allergic contact dermatitis
Clonidine 5 - 30% Irritant and allergic contact
dermatitis
Estradiol 17% Erythema (redness)
Nitroglycerin 5 - 16% Erythema
Fentanyl 39% Erythema
9% Pruritis (itching)
Nicotine 38% Pruritis
Testosterone 37% Pruritis
12% Blistering
7% Erythema
</TABLE>
- ---------------
* Ranges reflect differing results achieved when more than one study was
conducted.
23
<PAGE> 25
Recent efforts to expand the number and type of drugs delivered
transdermally include the use of iontophoresis (mild electrical charges) or
ultrasound waves in order to help drive the drug through the stratum corneum.
While these approaches may prove successful for a few drugs, the Company
believes that the resulting inflammatory skin reactions and higher product costs
are likely to limit the use of these techniques.
With the advent of biotechnology, the discovery and development of larger
molecular size drugs (including proteins, peptides and oligonucleotides) has
increased significantly. As many of these potentially breakthrough new drugs are
amenable only to injectable administration, the Company believes that
transdermal methods to deliver these products represent an increasingly large
commercial opportunity. Thus, the need to find new methods to expand the type
and number of therapeutic agents deliverable by transdermal methods, while at
the same time minimizing the incidence of adverse skin reactions, has assumed
greater importance. Cellegy's approach to this challenge has been to develop
novel technologies which (i) do not rely on solvent permeation enhancers, (ii)
increase the size of molecules deliverable through the skin and (iii)
significantly mitigate skin irritation.
CELLEGY'S PROPRIETARY TECHNOLOGIES
Cellegy's focus on the biological functioning of the skin has permitted
development of two novel technologies: (i) PERMEATE, which appears to be capable
of enhancing the delivery of drugs applied to the skin for systemic delivery or
for the treatment of local skin conditions, and (ii) CELLEDIRM, which appears to
be capable of mitigating the irritation and inflammation caused when drugs,
solvents and other substances come into contact with the skin.
PERMEATE Drug Delivery Technology
PERMEATE is a patented technology which employs bioactive permeation
enhancers to permit the passage of larger molecule drugs into or through the
skin. This technology represents a variety of methods to manipulate the three
primary lipids which dictate the barrier properties of the stratum corneum:
cholesterol, ceramides and free fatty acids. Normal barrier function requires a
specific critical ratio of these three lipids. The Company has shown that its
newly identified enhancers can alter these lipid ratios to increase the
permeability of the skin by inhibiting specific enzymes responsible for the
synthesis or processing of these lipids, or by inducing defects in the rigid
lipid structures of the stratum corneum.
Cellegy's PERMEATE system has the potential of being able to open the
stratum corneum barrier wider than believed possible before, and to keep it open
longer than conventional solvent approaches. This has been found in preclinical
studies to facilitate the permeation of larger or more insoluble drugs into the
skin or into the bloodstream. Further, Cellegy's PERMEATE technology potentially
enables transdermal delivery of such drugs without using energy dependent
systems, such as iontophoresis, electroporation, ultrasound or laser. Cellegy's
studies to date have also shown that these enhancers can exert their effect when
formulated as topical creams or gels or in conventional transdermal patches.
The Company's research findings include the evaluation of selected PERMEATE
systems in conjunction with the following drugs: testosterone, vasopressin,
luteinizing hormone releasing hormone ("LHRH"), lidocaine, cimetidine,
hydrocortisone and caffeine. Experimental findings with these drugs indicated
that PERMEATE was capable in animal models of delivering up to ten times more
drug than attainable using conventional solvent approaches. Further, two of
these compounds (LHRH and vasopressin) delivered using the Company's PERMEATE
technology are peptides which, to the Company's knowledge, have never before
been delivered transdermally using conventional solvent technologies. The
molecular weights of LHRH and vasopressin (approximately 1000 and 1200,
respectively) are significantly greater than the molecular weights of drugs
delivered using currently approved transdermal patches (no more than
approximately 400 molecular weight).
CELLEDIRM Technology
CELLEDIRM is a group of compounds identified by Cellegy's scientists which
have in preclinical evaluations been found to be capable of reducing the
inflammation associated with the topical application of
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<PAGE> 26
drugs, solvents or other physiologically active substances. These compounds
consist of specially processed or purified excipients that have been shown in
preclinical studies to significantly reduce skin inflammation following
challenge with a number of irritating or allergenic substances.
The Company has conducted a number of research studies investigating the
utility of CELLEDIRM in mitigating the symptoms of skin inflammation. These
compounds have been shown to reduce inflammation by up to 40% in animal models
challenged with either a potent irritant or an allergen. These effects are
comparable to those achieved with topical corticosteroids. The ability of
CELLEDIRM to reduce the inflammation caused by irritants also has been confirmed
in humans using a standard soap chamber test.
The Company expects its proprietary CELLEDIRM technology to complement its
PERMEATE drug delivery system and to provide a unique platform for the
development of novel topical products which could benefit from the
anti-inflammatory or anti-allergic activities of CELLEDIRM. Since the active
ingredients within CELLEDIRM are either GRAS (generally regarded as safe) or
used as excipients in various pharmaceutical or cosmetic products, the Company
believes the use of these compounds will not lengthen the FDA review process of
therapeutic drug products in which they are used. Accordingly, the Company plans
to utilize these compounds in the near-term development of its testosterone and
other prescription products.
PRODUCTS UNDER DEVELOPMENT
The following table summarizes certain information concerning Cellegy's
clinical and preclinical prescription product candidates.
<TABLE>
<CAPTION>
PROPRIETARY
DEVELOPMENT TECHNOLOGIES
PRODUCTS INDICATIONS STATUS UTILIZED
- ----------------------- ----------------------- ----------------------- ------------
<S> <C> <C> <C>
PRESCRIPTION TOPICAL THERAPEUTICS
Glylorin n-CIE Phase III trials in Proprietary
progress
Ichthyosis vulgaris Phase II trials planned Proprietary
PRESCRIPTION PRODUCTS USING TRANSDERMAL DRUG DELIVERY TECHNOLOGY
Testosterone gel Hypogonadism (hormone Pilot studies in humans CELLEDIRM
therapy for male planned for late 1997
andropause)
Testosterone gel Female hormone therapy Preclinical evaluation CELLEDIRM
Estrogen-testosterone Female hormone therapy Research PERMEATE
gel CELLEDIRM
Immunosuppressive drug Psoriasis Research PERMEATE
CELLEDIRM
</TABLE>
PRESCRIPTION TOPICAL THERAPEUTICS
Glylorin (congenital primary ichthyosis: n-CIE)
Glylorin, the Company's most advanced topical prescription candidate, is
currently in Phase III clinical trials for the treatment of n-CIE. n-CIE is a
severe form of CPI, a group of incurable skin conditions for which there is
currently no satisfactory treatment. After successfully completing Phase II
clinical trials and commencing Phase III clinical trials in January 1996,
Cellegy licensed Glylorin to Glaxo in November 1996. Glaxo is one of the world's
largest pharmaceutical companies and a leader in the field of dermatology.
Ichthyosis is a family of related incurable skin diseases characterized by
a severe scaling of the skin that frequently affects large areas of the body. In
all forms of ichthyoses, skin cells form a rigid, thick surface layer of scales
that often discolor and crack. CPI is a group of the most severe and
debilitating forms of ichthyosis, affecting all age and ethnic groups. Many of
the most severely afflicted infants die shortly after birth from
25
<PAGE> 27
dehydration, hypothermia and microbes, which enter through the damaged
epidermis. Victims of the disease are currently treated with greases, emollients
and Lac-Hydrin (not indicated for treatment of CPI), which provide only limited
benefits, or with oral and topical retinoids, which have a risk of significant
toxicity. Approximately 100,000 people in the United States and at least an
equal number of persons outside the United States are afflicted with CPI.
Data from preclinical and clinical studies conducted to date have indicated
that Glylorin inhibits the scaling, as well as itching and other symptoms of
ichthyosis. It is a single medication with apparent multiple mechanisms of
action having the potential to:
- reverse skin barrier disruption and scaling by replenishing key barrier
membrane lipids;
- inhibit functioning of the white blood cells which invade the skin,
causing inflammation;
- kill a wide spectrum of bacteria, yeasts and fungi that are present in
scaling skin; and
- relieve itching and burning by reforming the barrier over exposed nerves.
In three Company-sponsored double-blind Phase II clinical studies on a
total of 27 patients, Glylorin appeared to effectively treat the two types of
CPI studied, n-CIE and neutral lipid storage disease. The studies showed that
Glylorin reduced the debilitating symptoms of the disease, including scaling,
induration (swelling) and erythema (redness) to a significantly greater degree
than the placebo. In the Phase II dose ranging study, which was conducted at
University of California, San Francisco and Yale University, different
formulation concentrations of Glylorin were tested twice daily over a six week
period to defined localized areas. Results with 15% Glylorin produced
statistically significant improvement in scaling (p=0.016), induration (p=0.006)
and erythema (p=0.047).
In January 1996, the Company commenced a double-blind, placebo controlled
Phase III clinical trial to evaluate the effectiveness of Glylorin in n-CIE,
which is one of the most severe forms of CPI. The study is being conducted at 23
clinical sites in the United States. The study protocol includes a four week
wash out followed by a twelve week blinded application of 15% Glylorin or
placebo to the entire body. After completion of the blinded phase of the study,
there is a nine month whole body open label application of 15% Glylorin for
safety analysis. After an interim safety analysis of the first ten patients, the
FDA permitted the subsequent enrollment of pediatric patients into the study. In
June 1997, Glaxo enrolled the last of 80 patients in the study.
Glylorin (other indications)
Glaxo, the Company's corporate partner for Glylorin, intends to conduct
clinical trials for the potential commercialization of Glylorin for other
disease indications. The second disease target is ichthyosis vulgaris, a milder
form of ichthyosis, affecting approximately one million people in the United
States. The disease is characterized by severe dry skin and scaling (although
not as thick as the scaling present in CPI). Lac-Hydrin, the only currently
approved prescription product for the treatment of ichthyosis vulgaris, has
certain side effects including irritation and stinging on thinner skin areas
such as the face. In addition, the product is not indicated for pediatric use.
The third disease to be targeted is seborrheic dermatitis. This condition,
characterized by skin redness, flaking and itching, is most commonly found on
the scalp. Seborrheic dermatitis afflicts approximately seven million people in
the United States, primarily among the very young and the elderly.
PRESCRIPTION PRODUCTS USING TRANSDERMAL DRUG DELIVERY TECHNOLOGIES
Testosterone Gel (male hormone replacement therapy)
The Company's most advanced transdermal drug delivery candidate is a
transdermal testosterone gel. The product will address a condition increasingly
referred to as "male andropause" which results from an age-related decline in
the body's production of the sex hormone testosterone. Low levels of
testosterone can result in such clinical symptoms as lethargy, depression and a
decline in libido. In severely deficient cases, loss of muscle and bone mass can
occur. Approximately 5 million men in the United States, primarily in the aging
26
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(over 40) male population group, have lower than normal levels of testosterone,
a condition known as hypogonadism.
There are a number of companies currently marketing testosterone in several
different product forms in domestic and certain international markets. Cellegy
believes that a major market opportunity exists for an improved product as the
side effects and patient inconveniences associated with the currently marketed
products has limited their use to less than 5% of potential patients. Major
current product forms include:
Orals. Oral testosterone products are inconvenient since they must be
taken three to four times per day. Prolonged use can cause liver toxicity
due to interference with hepatic enzyme activity.
Injectables. The large volume, oil-based testosterone injections that
are currently marketed can cause pain and inflammation at the injection
site. In addition, frequent doctor visits are inconvenient, and injections
can produce fluctuations in blood testosterone levels which can result in
unwanted mood and energy swings.
Transdermal Patches. Two companies have FDA approved patch products
which have captured a large portion of the existing United States market
since their introduction in 1995. Although the patches alleviated a number
of the shortcomings of the orals and injectables, solvents used to enhance
delivery of testosterone across the skin frequently cause skin irritation.
In addition, one of the patches marketed is applied to the scrotum, which
has proved to be highly inconvenient for the patient.
Cellegy is developing a patchless testosterone gel which will incorporate
the Company's CELLEDIRM technology. The gel product is expected to permit a
once-a-day application of a metered dose to a small area of the skin without the
irritation associated with current patch products. The gel is expected to be
transparent, rapid drying and non-staining. Based on preclinical studies to
date, the Company believes its proprietary transdermal gel formulation is
capable of delivering therapeutic levels of testosterone with reduced side
effects and in a more convenient dosage form compared with other currently
marketed products. The preclinical studies demonstrated transdermal testosterone
delivery into the blood stream at levels comparable to a leading patch product.
The Company plans to commence a human safety and pharmacokinetic study
using various testosterone gel formulations before the end of 1997. If the study
is successful, additional human trials are planned for 1998. The Company
believes that due to well documented toxicology and efficacy data regarding the
use of testosterone, regulatory approval of its transdermal testosterone gel may
be achieved more quickly than would normally be associated with a new chemical
entity.
Testosterone Gel (female hormone replacement therapy)
In women, the ovaries and adrenal glands continue to synthesize
testosterone after menopause, although the rate of production may diminished by
as much as 50%. Normal blood concentrations of testosterone in women range from
10 to 20 times less than that of men. Nevertheless, in both sexes, testosterone
plays a key role in building muscle or bone tissue, and the maintenance of
sexual drive.
Cellegy's testosterone gel product (for the treatment of hypogonadism) has
been designed so that the dose can be readily reduced and customized to restore
normal testosterone levels in women. The Company believes that this change may
be accomplished by reducing the amount of gel delivered via a metered dose
without a significant change in the product formulation. Thus, the Company
believes that the same formulation can be developed and tested for use in both
hypogonadism and menopause. Clinical studies for this indication are planned to
commence once the initial studies in hypogonadal males are completed. This study
will focus on the evaluation of oophorectomized women, or women with clinically
deficient testosterone levels. The study will also consider the effects on
sexual function or bone loss.
Estrogen-Testosterone Gel (female hormone replacement therapy)
Currently, there are more than 20 million postmenopausal or menopausal
women in the United States suffering from low hormone levels, which number is
expected to increase given the aging trend of the female
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population. The current market size for female hormone replacement products
exceeds $2 billion in sales on a worldwide basis. These products include natural
and synthetic estrogen and progestin therapies.
Cellegy's third planned product in the area of hormone replacement therapy
will be a combination estrogentestosterone gel utilizing the Company's
proprietary PERMEATE and CELLEDIRM technologies, designed to simultaneously
restore the natural levels of both hormones in elderly or menopausal women. The
Company believes that this product will offer significant advantages over the
patches under development in terms of reduced side effects and patient
convenience. It will provide women with an easy to use, transparent alternative
for topical hormone replacement. The combination formulation is in the research
stage with clinical trials planned following development of the mono-therapy
testosterone products.
Immunosuppressive Drug (psoriasis)
Cellegy is developing a product for the treatment of psoriasis that is
expected to employ an FDA approved immunosuppressive drug in a topical
formulation designed specifically for local delivery into psoriatic lesions.
This product will utilize the Company's proprietary PERMEATE technology to keep
the barrier of psoriatic lesions open for delivery of the therapeutic agent,
potentially leading to a final normalization of epidermis function. If
successfully developed, healing will be accomplished with minimal systemic
effect and without the toxicities generally associated with immunosuppressive
drugs.
Psoriasis is a relatively common disease affecting approximately four
million individuals in the United States. This intractable condition is
characterized by inflammation and accelerated growth of the epidermis resulting
in dull red, scaly plaques distributed on the scalp, knees, elbows, hands, feet
and buttocks. The disease can be activated by infection and barrier damage. The
total annual cost to the health care system for this disease is estimated to be
greater than $3 billion. A large percentage of patients on extant therapies are
not satisfactorily relieved of psoriatic symptoms and are constantly seeking
more effective therapy.
COSMECEUTICAL PRODUCTS
Cosmeceuticals (a hybrid of the words cosmetics and pharmaceuticals) are
products that contain active ingredients which when applied to the skin will
enhance appearance. Cosmeceuticals that satisfy the legal definition of a
cosmetic under the FD&C Act, and that are not also drugs under that statute, are
not subject to the same FDA regulations as drug products. Such cosmeceuticals
may be marketed to consumers without prior approval by the FDA and without
requiring a prescription from a physician.
The anti-wrinkling segment of the cosmeceutical market in the United States
is split approximately equally among mass merchandisers, department and
specialty stores and professional groups. Sales through professional groups are
currently made predominantly by dermatologists, plastic surgeons and medical
aestheticians, who frequently see patients with specific or special skin care
needs. Dermatologists and plastic surgeons are increasingly purchasing
cosmeceutical products for resale to their patients from their own clinics to
supplement their revenue.
The total cosmeceutical market in the United States was estimated to be
approximately $2.5 billion in annual sales for 1996 and is expected to increase
to approximately $3.3 billion by the year 2000. Cellegy expects that the demand
for cosmeceutical products will continue to increase because of the aging of the
American population.
Cellegy intends to develop high performance cosmeceutical products
incorporating its CELLEDIRM technology. Based on studies conducted to date,
CELLEDIRM appears to have the ability to prevent or reduce the irritation
frequently caused by the active ingredients that are included in certain
cosmetic products. The Company intends to market its cosmeceutical products to
physicians and other professionals, including dermatologists, plastic surgeons
and medical aestheticians. Cellegy plans to demonstrate the quality and
superiority of its cosmeceutical products over competitive offerings through a
rigorous scientific and human testing program.
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The following table summarizes certain information concerning Cellegy's
cosmeceutical product candidates.
<TABLE>
<CAPTION>
DEVELOPMENT TECHNOLOGIES
PRODUCTS INDICATIONS STATUS UTILIZED
- ----------------------- ----------------------- ----------------------- ------------
<S> <C> <C> <C>
Anti-wrinkling Photodamaged and aging In human testing CELLEDIRM
products* skin
Anti-irritant cream Irritated, red, itchy Formulation development CELLEDIRM
skin
Other skin care Dry and disrupted skin Formulations complete; CELLEDIRM
products............. ready for marketing
</TABLE>
- ---------------
* References in this Prospectus to "anti-wrinkling," "anti-wrinkling products"
or the "anti-wrinkling market" are intended to refer to a product category
that the Company believes is generally understood in the marketplace or to
products in that category, and are not intended to describe any claims that
the Company's cosmeceutical products act in any way other than as cosmetics as
defined under applicable laws. The term "cosmeceuticals" refers to products
which, if they satisfy the definition of a cosmetic under applicable federal
laws and if they are not also drugs under those laws, are not subject to the
same requirements as drug products. See "Risk Factors -- Possible FDA
Regulation of Cosmeceutical Products as Drugs" and "Business -- Government
Regulation."
Anti-Wrinkling Products
The Company's most advanced cosmeceutical is an anti-wrinkling product
designed to mitigate the visible effects of photoaging and skin wrinkling.
Cellegy's anti-wrinkling product will be included in a line of products that the
Company expects to produce greater improvement to the skin's appearance and
cause less irritation than current market leading products. Cellegy commenced
human evaluation of this product line during the second quarter of 1997 and
expects to begin commercial sales during 1998.
Cellegy's high performance anti-wrinkling line will consist of six to nine
complementary products, which together will constitute a complete system. The
system is expected to include facial creams and lotions, eye creams, a cleanser
and a moisturizer. The Company anticipates that subsequent line extensions will
be designed for specific ages, skin sites and skin types.
Signs of aging and photoaging usually become visible when people reach
their early thirties, with fine wrinkling, loss of suppleness and elasticity of
the skin becoming apparent. In subsequent decades, there is further
deterioration marked by coarse wrinkles, irregular increased pigmentation, and
thinning and fragility of the skin. Many of the skin changes associated with
aging are due to ultraviolet light exposure, referred to as "photoaging." At the
retail level, the non-prescription market for products which are used to
mitigate the effects of aging and photodamage upon the skin is estimated to be
in excess of $1 billion in annual sales in the United States and growing at
approximately 14% per year.
The current high performance cosmeceutical anti-wrinkling market in the
United States consists of four broad categories of products:
Retinoids are derived from vitamin A and related compounds and include
both prescription and cosmeceutical products. Retinoids increase the rate
of cell turnover and thereby reduce the appearance of wrinkles.
Alpha Hydroxy Acids ("AHAs") are a class of compounds which have been
used by professionals for years in chemical peels and were introduced at
the consumer level in lower concentrations in the early 1990s. AHAs promote
exfoliation and thereby reduce the appearance of wrinkles. Glycolic Acid is
the most widely used of the AHAs.
Beta Hydroxy Acids were recently introduced, with salicylic acid being
the first such compound. As with the AHAs, beta hydroxy acids promote
exfoliation and thereby reduce the appearance of wrinkles.
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Anti-Oxidants such as Vitamin C and E (and their derivatives) applied
directly to the skin are believed to mitigate the effects of oxidative
stress, or damage caused by ultraviolet light exposure, ozone and other
damaging environmental factors.
Many of the currently marketed cosmeceutical products contain low
concentrations of one or more of the above active ingredients, and, to the
Company's knowledge, their efficacy has not generally been supported by clinical
studies. Low concentrations of the active ingredients are employed in order to
avoid side effects which can include stinging, redness and skin irritation, and
which generally increase with the concentration of active ingredient used.
However, the low concentrations of the active ingredient generally limit the
efficacy of the products.
Cellegy's high-performance anti-wrinkling products incorporate CELLEDIRM,
together with an active ingredient having multi-action capability exhibiting
many of the attributes of the cosmeceutical products in the categories listed
above. Human studies planned for next year will provide comparative data versus
certain leading cosmeceutical products. If successfully developed, the Company
believes the product line could be available for launch during 1998. Cellegy
will focus its marketing efforts on the professional market segment,
capitalizing on the Company's research and human studies and its expertise in
skin biology.
Anti-Irritant Cream
Non-specific skin conditions, including various forms of dry, irritated,
itchy skin, have a significant economic impact. Dermatologists as a group rely
heavily on topical products. Cellegy's anti-irritant cream will be designed to
restore and soothe irritated, itchy skin. This product will incorporate natural
substances from the Company's CELLEDIRM technology with a proven use and safety
record. The product will be made available to dermatologists as a high
performance cosmeceutical alternative to skin care products or lotions which are
frequently used by these physicians to restore irritated and itchy skin.
Other Skin Care Products
The Company has completed development of certain other consumer skin care
products, including moisturizers and body creams and is continuing to develop
formulations in other related skin care consumer product categories. These
products utilize certain of the Company's proprietary formulations. These
formulations were tested for their moisturizing properties in humans compared
with a leading commercial product. Results showed that the Cellegy formulations
had more than a 50% higher moisturization effect on untreated skin 12 hours
after application than the leading product tested. The Company expects to sell
these products to consumer products companies who will market them under their
own brand names through traditional, non-physician channels.
LICENSE AGREEMENTS
Glaxo. In November 1996, the Company entered into an agreement with Glaxo
for licensing rights to Glylorin, Cellegy's lipid compound for the treatment of
ichthyosis. Under the terms of the agreement, Cellegy provided Glaxo with an
exclusive license of patent rights and know-how covering Glylorin in most of the
world's major markets. In exchange for this license, Cellegy received from Glaxo
an initial license fee payment and could potentially receive future milestone
payments (upon achievement of the specified milestones) totaling, including the
initial payment, over $8.0 million, as well as a royalty on net sales assuming
successful completion of product development and market launch. There can be no
assurances, however, that the Company will receive any additional payments from
Glaxo. The agreement provides that Glaxo will assume responsibility for and the
associated costs of all future development and commercialization, including
certain development costs incurred prior to the date of the agreement. Through
September 30, 1997, the Company had recognized total revenues of approximately
$1.0 million relating to licensing fees and development funding under the
agreement.
University of California. In October 1993, the Company entered into a
license agreement with the University of California (the "Licensor") providing
for an exclusive, worldwide, royalty bearing license, subject to customary
government rights, for patent rights relating to barrier repair formulations
jointly held by
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<PAGE> 32
the Licensor and the Company, in consideration of the issuance to the Licensor
of certain shares of preferred stock (which subsequently converted into shares
of Common Stock) and the payment by the Company of a licensing fee. In March
1994, the Company entered into a second exclusive, worldwide, royalty bearing
license agreement with the Licensor for patent rights, jointly held by the
Licensor and Cellegy, relating to drug delivery technologies, in consideration
of the payment by the Company of a licensing fee, and an annual maintenance fee
payable each year until the Company is commercially selling a licensed product.
Both agreements require the Company to pay the Licensor royalties based on net
sales of consumer and prescription products (with minimum annual royalty
payment). The Company has the right to grant sublicenses to third parties under
both agreements. In May and October 1997, the Licensor and the Company amended
these agreements. The amendments, among other things, modified and extended
certain development and commercialization milestones contained in the original
agreements. The revised milestones are tied to the achievement of certain
clinical, regulatory or product commercialization goals over the next several
years. Although there can be no assurance that such goals will be achieved, the
Company believes its development programs in place will result in the
satisfaction of such milestones.
Neutrogena. In April 1992, the Company entered into the License Option
Agreement (the "License Option Agreement"), the Azelaic Acid OTC License
Agreement (the "Azelaic Acid Agreement") and the Metabolic Moisturizer OTC
License Agreement (the "Metabolic Moisturizer Agreement"), with Neutrogena. The
Azelaic Acid Agreement was terminated and replaced by the Patent License
Agreement effective June 1, 1994 (the "Patent License Agreement"). Pursuant to
the Patent License Agreement, Neutrogena paid the Company $1.0 million for an
exclusive, royalty-free license for certain azelaic acid uses for both
prescription and consumer products in most major markets of the world. In July
1997, Neutrogena and the Company terminated the Metabolic Moisturizer Agreement
and the License Option Agreement (except as it related to azelaic acid), and the
metabolic moisturizer technology that had been licensed to Neutrogena was
returned to the Company. The Company agreed to continue prosecution of patents
related to azelaic acid on behalf of Neutrogena and will be reimbursed by
Neutrogena for legal costs, up to a certain limit.
PATENTS AND TRADE SECRETS
The Company's success depends, in part, on its ability to obtain patent
protection for its products and methods, both in the United States and in other
countries. The patent position of companies engaged in businesses such as the
Company's business generally is uncertain and involves complex legal and factual
questions. There is a substantial backlog of patent applications at the USPTO.
Patents in the United States are issued to the party that is first to invent the
claimed invention. Since patent applications in the United States are maintained
in secrecy until patents issue, the Company cannot be certain that it was the
first inventor of the invention covered by its pending patent applications or
patents or that it was the first to file patent applications for such
inventions. Further, issued patents can later be held invalid by the patent
office issuing the patent or by a court. There can be no assurance that any
patent applications relating to the Company's products or methods will issue as
patents, or, if issued, that the patents will not be challenged, invalidated, or
circumvented or that the rights granted thereunder will provide a competitive
advantage to the Company. In addition, many other entities are engaged in
research and product development efforts in drug delivery, skin biology and
cosmeceutical fields that may overlap with the Company's currently anticipated
and future products. A substantial number of patents have been issued to such
companies, and such companies may have filed applications for, or may have been
issued patents or may obtain additional patents and proprietary rights relating
to, products or processes competitive with those of the Company. Such entities
may currently have, or may obtain in the future, legally blocking proprietary
rights, including patent rights, in one or more products or methods under
development or consideration by the Company. These rights may prevent the
Company from commercializing technology, or may require the Company to obtain a
license from the entity to practice the technology. There can be no assurance
that the Company will be able to obtain any such licenses that may be required
on commercially reasonable terms, if at all, or that the patents underlying any
such licenses will be valid or enforceable. Moreover, the laws of certain
foreign countries do not protect intellectual property rights relating to United
States patents as extensively as those rights are protected in the United
States. The issuance of a patent in one country does not assure the issuance of
a patent with similar
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<PAGE> 33
claims in another country, and claim interpretation and infringement laws vary
among countries, so the extent of any patent protection is uncertain and may
vary in different countries. As with other companies in the pharmaceutical
industry, the Company is subject to the risk that persons located in such
countries will engage in development, marketing or sales activities of products
that would infringe the Company's patent rights if such activities were in the
United States.
Several of the Company's products are based on existing compounds with a
history of use in humans but which are being developed by the Company for new
therapeutic use in skin diseases unrelated to the systemic diseases for which
the compounds were previously approved. The Company cannot obtain composition
patent claims on the compound itself, and will instead need to rely on patent
claims, if any, directed to use of the compound to treat certain conditions or
to specific formulations. The Company will not be able to prevent a competitor
from using that formulation or compound for a different purpose. No assurance
can be given that any additional patents will be issued to the Company, that the
protection of any patents that may be issued in the future will be significant,
or that current or future patents will be held valid if subsequently challenged.
The agreements with the University of California, San Francisco, pursuant
to which the Company has exclusive license rights to certain barrier repair and
drug delivery and other technology contain certain development and performance
milestones which the Company must satisfy in order to retain such rights. While
the Company currently believes it will be able to satisfy the revised milestone
dates, a loss of rights to these technologies could have a material adverse
effect on the Company.
The Company has 10 issued and one allowed United States patents, many
issued foreign patents and pending patent applications for the use of certain
compounds to treat common or severe inflammatory dermatologic diseases including
dermatitis, psoriasis, rosacea and acne, as well as disorders such as various
ichthyoses, signs and symptoms of skin aging and premalignant actinic keratoses.
Three issued United States patents and more than 20 patent applications relate
to the Company's Glylorin product for the treatment of ichthyosis and certain
other skin diseases and conditions. One allowed United States patent and more
than 10 patent applications relate to the drug delivery technology licensed from
the University of California, and one issued United States patent and at least
10 patent applications relate to the barrier repair technology licensed from the
University of California. Additional patent applications are being prepared for
filing that will cover methods or products currently under development.
Corresponding patent applications for most of the Company's issued United States
patents have been filed in countries of importance to the Company located in
major world markets, including certain countries in Europe, Australia, South
Korea, Japan, Mexico and Canada.
Federal patent law provides that for any inventions that have been
developed with government funding that are the subject of a license, the
government has the right to require the assignor or the licensee to grant a
license to third parties upon the occurrence of certain events, such as if the
government determines that no effective steps have been taken to achieve
practical application of the invention, or if health or safety needs or
requirements for public use are not reasonably satisfied.
The Company's policy is to protect its technology by, among other things,
filing patent applications for technology that it considers important to the
development of its business. The Company intends to file additional patent
applications, when appropriate, relating to its technology, improvements to its
technology and to specific products that it develops. It is impossible to
anticipate the breadth or degree of protection that any such patents will
afford, or whether the Company can meaningfully protect its rights to its
unpatented trade secrets. The Company also relies upon unpatented trade secrets
and know-how, and no assurance can be given that others will not independently
develop substantially equivalent proprietary information and techniques, or
otherwise gain access to the Company's trade secrets or disclose such
technology, or that the Company can meaningfully protect its rights to its
unpatented trade secrets. It is the Company's policy to require its employees to
execute an invention assignment and confidentiality agreement upon employment.
Cellegy's consultants are required to execute a confidentiality agreement upon
the commencement of their consultancy to the Company. Each agreement provides
that all confidential information developed or made known to the employee or
consultant during the course of employment or consultancy will be kept
confidential and not disclosed to third parties except in specific
circumstances. The invention assignment generally
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<PAGE> 34
provides that all inventions conceived by the employee shall be the exclusive
property of the Company. In addition, it is the Company's policy to require the
collaborators and potential collaborators to enter into confidentiality
agreements. There can be no assurance, however, that these agreements will
provide meaningful protection for the Company's trade secrets.
GOVERNMENT REGULATION
FDA Requirements for Human Drugs. The research, testing, manufacturing,
labeling, distribution, and marketing of drug products are extensively regulated
by numerous governmental authorities in the United States and other countries.
In the United States, drugs are subject to rigorous FDA regulation. The FD&C Act
and the regulations promulgated thereunder, and other federal and state
regulations govern, among other things, the research, development, testing,
manufacture, distribution, storage, record keeping, labeling, advertising,
promotion and marketing of pharmaceutical products. The process of developing
and obtaining approval for a new pharmaceutical product within this regulatory
framework requires a number of years and the expenditure of substantial
resources. There can be no assurance that necessary approvals will be obtained
on a timely basis, if at all. Moreover, additional government regulations may be
established that could prevent or delay regulatory approval of the Company's
products. Delays in obtaining regulatory approvals could have a material adverse
effect on the Company. Failure to comply with applicable regulatory requirements
for marketing drugs or the proper labeling claims for cosmetics may subject a
company to administrative or judicially imposed sanctions such as warning
letters, fines, products recalls or seizures, injunctions against production,
distribution, sales, or marketing, delays in obtaining marketing authorizations
or the refusal of the government to grant such approvals, suspensions and
withdrawals of previously granted approvals, civil penalties and criminal
prosecution of a company, its officers or its employees.
The steps ordinarily required before a new pharmaceutical product may be
marketed in the United States include: (i) preclinical laboratory tests, animal
studies and formulation studies; (ii) the submission to the FDA of an
Investigational New Drug Application ("IND") , which must become effective
before clinical testing may commence; (iii) adequate and well-controlled
clinical trials to establish the safety and efficacy of the product for its
proposed indication; (iv) the submission of a New Drug Application ("NDA") to
the FDA; and (v) FDA review and approval of the NDA prior to any commercial sale
or shipment of the drug. Preclinical tests include laboratory evaluation of
product chemistry and formulation, as well as animal studies to assess the
potential safety and functionality of the product. Compounds must be produced
according to the FDA's current Good Manufacturing Practice ("cGMP")
requirements, and preclinical tests must be conducted in compliance with the
FDA's Good Laboratory Practice regulations. The results of preclinical testing
are submitted to the FDA as part of an IND. A 30-day waiting period after the
filing of each IND is required prior to the commencement of clinical testing in
humans. If the FDA has not commented upon or questioned the IND within this
30-day period, clinical studies may begin. If the FDA has comments or questions,
the questions must be answered to the satisfaction of the FDA before initial
clinical testing can begin. In addition, the FDA may, at any time, impose a
clinical hold on ongoing clinical trials. If the FDA imposes a clinical hold,
clinical trials may not commence or recommence without FDA authorization and
then only under terms authorized by the FDA. In some instances, the IND
application process can result in substantial delay and expense.
Clinical trials involve the administration of the investigational product
to healthy volunteers or patients under the supervision of a qualified
investigator. Clinical trials must be conducted in accordance with good clinical
practices ("GCP") under protocols detailing the objectives of the study, the
parameters to be used in monitoring safety and the effectiveness criteria to be
evaluated. Each protocol must be submitted to the FDA as part of the IND.
Further, each clinical study must be conducted under the auspices of an
independent Institutional Review Board ("IRB") at the institution at which the
study will be conducted. The IRB will consider, among other things, ethical
issues, the safety of human subjects and the possible liability of the
institution. Clinical trials to support NDAs are typically conducted in three
sequential phases, which may overlap. In Phase I, the initial introduction of
the drug into healthy human subjects or patients, the drug generally is tested
to assess metabolism, pharmacokinetics, pharmacological action and safety,
including side effects associated with increasing doses, and if possible, to
gain early evidence on effectiveness. Phase II
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usually involves studies in a limited patient population to (i) determine the
efficacy of the drug for a specific indication, (ii) determine dosage tolerance
and optimal dosage and (iii) identify possible short-term adverse effects and
safety risks. If a compound is found to be effective and to have an acceptable
safety profile in Phase II evaluations, Phase III trials are undertaken to
further evaluate clinical efficacy, usually (although not necessarily) in
comparison with a placebo or approved treatment and to further test for safety
within an expanded patient population at geographically dispersed clinical study
sites. A clinical trial may combine the elements of more than one phase, and
typically two or more Phase III studies are required. The designation of a
clinical trial as being in a particular phase is not necessarily indicative that
such a trial will be sufficient to satisfy the requirements of a particular
phase. For example, no assurance can be given that a Phase III clinical trial
will be sufficient to support an NDA without further clinical trials. There can
be no assurance that Phase I, Phase II or Phase III testing will be completed
within any specific time period, if at all, with respect to any of the Company's
products subject to such testing.
New and Abbreviated New Drug Applications. After completion of the
required clinical testing, generally an NDA is submitted. FDA approval of the
NDA (or, in the alternative, an Abbreviated New Drug Application ("ANDA"), as
described below) is required before marketing may begin in the United States.
The NDA must include the results of extensive clinical and other testing and the
compilation of data relating to the product's chemistry, pharmacology and
manufacture, the cost of all of which is substantial. The FDA reviews all NDAs
submitted before it accepts them for filing and may request additional
information rather than filing an NDA. In such an event, the NDA must be
resubmitted with the additional information and, again, is subject to review
before filing. Once the submission is accepted for filing, the FDA begins an
in-depth review of the NDA. Under the FD&C Act, the FDA has 180 days in which to
review the NDA and respond to the applicant, although in practice the process
generally takes longer. The review process is often extended significantly by
FDA requests for additional information or clarification. The FDA may refer the
application to the appropriate advisory committee, typically a panel of
clinicians, for review, evaluation and a recommendation as to whether the
application should be approved. The FDA is not bound by the recommendation of an
advisory committee. During the review process, the FDA generally will conduct an
inspection of the relevant drug manufacturing facilities and clinical sites to
ensure that the facilities are in compliance with applicable cGMP and GCP
requirements. If FDA evaluations of the NDA application, manufacturing
facilities, and clinical sites are favorable, the FDA may issue either an
approval letter or an approvable letter, which contains a number of conditions
that must be met in order to secure approval of the NDA. When and if those
conditions have been met to the FDA's satisfaction, the FDA will issue an
approval letter, authorizing commercial marketing of the drug for certain
specific indications. If the FDA's evaluation of the NDA submission or
manufacturing facilities is not favorable, the FDA may refuse to approve the NDA
or issue a not approvable letter, outlining the deficiencies in the submission
and often requiring additional testing or information. Notwithstanding the
submission of any requested additional data or information in response to an
approvable or not approvable letter, the FDA ultimately may decide that the
application does not satisfy the regulatory criteria for approval. Even if FDA
approval is obtained, a marketed drug product and its manufacturer are subject
to continual review and inspection, and later discovery of previously unknown
problems with the product or manufacturer may result in restrictions or
sanctions on such product or manufacturer, including withdrawal of the product
from the market, and other enforcement actions. The FDA may also require
postmarketing testing and surveillance programs to continuously monitor the
drug's usage and effects. Side effects resulting from the use of drug products
may prevent or limit the further marketing of products.
Certain of the Company's mid and late term products utilize its drug
delivery technology formulated with an active ingredient that is included in a
drug product that is already the subject of an NDA approved by the FDA. In
connection with obtaining FDA approval of such Company products which require an
NDA, it is possible in certain instances that clinical and preclinical testing
requirements may not be as extensive. Limited additional data about the safety
or effectiveness of the proposed new drug formulation, along with chemistry and
manufacturing information and public information about the active ingredient,
may be satisfactory for product approval. Consequently, the new product
formulation may receive marketing approval more rapidly than a traditional full
NDA, although there can be no assurance that a product will be granted such
treatment by the FDA.
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<PAGE> 36
Once patent and other statutory protections covering a drug approved under
an NDA have expired or have been demonstrated not to apply, a generic equivalent
to that drug may be approved under an ANDA. An ANDA is ordinarily based upon
bioequivalence data that demonstrate that the rate and extent of absorption of
the active drug ingredient of the generic drug, usually measured in the blood
stream, is equivalent to that of the drug approved under an NDA. The
demonstration of bioequivalence and, therefore, ANDA approval, generally
requires less time than safety and efficacy studies and NDA approval.
Until an NDA or ANDA is actually approved, there can be no assurance that
the information requested and submitted will be considered adequate by the FDA
to justify approval. It is impossible to anticipate the amount of time that will
be required to obtain approval from the FDA to market any product.
Orphan Drug Designation. Under the Orphan Drug Act, the FDA may grant
orphan drug designation to drugs intended to treat a "rare disease or
condition," which generally is a disease or condition that affects populations
of fewer than 200,000 individuals in the United States. Orphan drug designation
must be requested before submitting an NDA. After the FDA grants orphan drug
designation, the generic identity of the therapeutic agent and its potential
orphan use are publicized by the FDA. Under current law, orphan drug designation
confers upon the first company to receive FDA approval to market such designated
drug United States marketing exclusivity for the designated drug and indication
for a period of seven years following approval of the NDA, subject to certain
limitations.
Orphan drug designation does not convey any advantage in, or shorten the
duration of, the regulatory approval process. Although obtaining FDA approval to
market a product with an orphan drug designation can be advantageous, there can
be no assurance that the scope of protection or the seven years of market
exclusivity that is currently afforded by orphan drug designation and marketing
approval will remain in effect in the future.
Possible Regulation of Cosmeceutical Products as Drugs. "Cosmeceuticals"
are not defined in the FD&C Act. The FDA has not defined the term by regulation
and may consider use of the term to imply drug-like qualities. The FDA will
regulate a particular cosmeceutical product as a drug or a cosmetic (or both a
drug and a cosmetic) depending primarily upon the manufacturer's intended use
for such product. Such intent may be determined from labeling, advertising,
promotional and marketing materials, and any other source attributable to the
manufacturer or its employees, representatives or agents. Under the FD&C Act,
drugs are articles intended for use in the diagnosis, cure, mitigation,
treatment or prevention of disease or to affect the structure or function of the
body. By comparison, cosmetic products are defined as articles intended to be
rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to
the body for cleansing, beautifying, promoting attractiveness or altering its
appearance. Some products, however, may satisfy the definition of a drug and a
cosmetic, and the FDA has generally regulated as drugs products that are
intended to have a physiological effect on the body, for example, to alter the
skin in more than a temporary way. Unlike drugs, products that constitute
cosmetics (but not drugs as well) under the FD&C Act do not require premarket
review or approval of the FDA, but cosmetics must be safe under normal
conditions of use, and comply with FDA labeling and manufacturing requirements.
Furthermore, the Federal Trade Commission ("FTC"), as well as state and local
authorities, oversees the advertising of cosmetic products and prohibits false,
misleading, deceptive or unsubstantiated advertising. The FTC has the authority
to seek a number of remedies against a company that it believes fails to comply
with its requirements, including, but not limited to, preliminary injunctive
relief.
The Company plans to label, market, promote, advertise and distribute its
cosmeceutical products with claims intended to be within the statutory
definition of cosmetic. There can be no assurance, however, that the FDA will
not determine that some or all of the Company's cosmeceutical products are
drugs, and are therefore subject to more stringent regulatory oversight,
including premarket approval, based on their intended use or ingredients.
The FDA has at times in the past contended, and may in the future contend,
that one or more cosmeceutical products, including the Company's or competitors'
anti-wrinkling products that are currently marketed or may in the future be
marketed, are not cosmetics but instead are subject to regulation as drugs. Even
if the FDA were not ultimately to prevail with regard to such a contention, such
a claim by the FDA
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<PAGE> 37
could have a material adverse effect on the Company's ability to market its
proposed cosmeceutical products and could significantly delay or prohibit
marketing of such products. The extent to which different kinds of current or
future cosmeceutical products of the Company or its competitors are subject to
FDA regulation as drugs, and the extent to which the FDA will seek to become
more active in regulating cosmeceutical products, such as products that compete
in the anti-wrinkling market, is uncertain, but will depend in part on the
claims made for the cosmeceuticals by their manufacturers and marketers. See
"Business -- Government Regulation." The inability of the Company to market its
proposed cosmeceutical products as cosmetics without prior FDA approval could
have a material adverse effect on the Company's business and financial
condition.
OTC Monograph. Most over the counter ("OTC") drug products marketed in the
United States are not subjected to the FD&C Act's premarket approval
requirements. In 1972, the FDA instituted the ongoing OTC Drug Review to
evaluate the safety and effectiveness of OTC drugs then on the market. Through
this process, the FDA issues monographs that set forth the specific active
ingredients, dosages, indications and labeling statements for OTC drugs that the
FDA will consider generally recognized as safe and effective and therefore not
subject to premarket approval. For certain categories of OTC drugs not yet
subject to a final monograph, the FDA usually will not take regulatory action
against such a product unless failure to do so poses a potential health hazard
to consumers. OTC drugs not covered by pending or final OTC monographs, however,
are subject to premarket review and approval by the FDA through the NDA/ANDA
mechanism. Even if the Company seeks FDA approval of a product for OTC consumer
sales, the FDA could instead require that the product be distributed by
prescription only. Such a requirement could delay for several years, or
indefinitely, distribution of the Company's products directly to consumers.
Manufacturing. Each domestic drug manufacturing facility must be
registered with the FDA. Domestic drug and, to a lesser extent, cosmetic
manufacturing establishments are subject to routine inspection by the FDA and
other regulatory authorities and must comply with cGMP (albeit less extensive
ones for cosmetics than for drugs). Drug manufacturing facilities located in
California must be licensed by the State of California in compliance with local
regulatory requirements. The Company intends to use contract manufacturers that
operate in conformance with these requirements to produce its compounds and
finished products in commercial quantities. There can be no assurance that
manufacturing or quality control problems will not arise at the manufacturing
plants of the Company's contract manufacturers or that such manufacturers will
be able to maintain the compliance with the FDA's current good manufacturing
practice requirements necessary to continue manufacturing the Company's
products.
Foreign Regulation of Drugs. Whether or not FDA approval has been
obtained, approval of a product by comparable regulatory authorities may be
necessary in foreign countries before the commencement of marketing of the
product in such countries. The approval procedure varies among countries, can
involve additional testing, and the time required may differ from that required
for FDA approval. Although there are some procedures for unified filings for
certain European countries, in general each country has its own procedures and
requirements, many of which are time consuming and expensive. Thus, there can be
substantial delays in obtaining required approvals from both the FDA and foreign
regulatory authorities after the relevant applications are filed. The Company
expects to rely principally on corporate partners, licensees and contract
research organizations, along with Company expertise, to obtain foreign
governmental approval in foreign countries of drug formulations utilizing its
compounds.
Other Government Regulation. In addition to regulations enforced by the
FDA, the Company also is subject to regulation under the Occupational Safety and
Health Act, the Environmental Protection Act, the Toxic Substances Control Act,
the Resource Conservation and Recovery Act and other similar federal and state
laws regarding, among other things, occupational safety, the use and handling of
radioisotopes, environmental protection and hazardous substance control. In
connection with its research and development activities and any manufacturing of
clinical trial materials in which the Company may engage, the Company is subject
to federal, state and local laws, rules, regulations and policies governing the
use, generation, manufacture, storage, air emission, effluent discharge,
handling and disposal of certain materials and wastes. Although the Company
believes that it has complied with these laws and regulations in all material
respects and has not been required to take any action to correct any
noncompliance, there can be no assurance that the Company will not be required
to incur significant costs to comply with environmental and health and safety
36
<PAGE> 38
regulations in the future. The Company's research and development involves the
controlled use of hazardous materials, chemicals, and various radioactive
compounds. Although the Company believes that its safety procedures for handling
and disposing of such materials comply with the standards prescribed by state
and federal regulations, the risk of accidental contamination or injury from
these materials cannot be completely eliminated. In the event of such an
accident, the Company could be held liable for any damages that result and any
such liability could exceed the resources of the Company.
Health Care Reform. In the United States, there have been, and the Company
expects there will continue to be, a number of federal and state proposals to
implement cost controls and other health care regulatory measures. Future
legislation could result in a substantial restructuring of the health care
delivery system. Nevertheless, the Company believes that employer-driven reform
with managed care and capitation will continue even without government
intervention and may significantly affect health care delivery and costs. While
the Company cannot predict whether any legislative or regulatory proposals will
be adopted or the effect such proposals may have on its business, the
uncertainty of such proposals could have an adverse effect on the Company's
ability to raise capital and to identify and reach agreements with potential
partners, and the adoption of such proposals could have an adverse effect on the
Company. For example, such changes could have the effect of reducing the number
of independent practicing dermatologists, which might reduce the number of
prescriptions written for products such as some of the Company's potential
products. In addition, the Company believes that many high-volume purchasers and
consumers of health care are demanding changes in the pricing and delivery of
products and services. The effect of any such changes on the Company's business
are unpredictable. One of the Company's potential products, such as its drug
delivery products, might have the effect of reducing the overall cost of
delivering therapeutic compounds compared to existing delivery techniques, and
sales of such products might benefit from regulatory changes focusing on
controlling health care costs. Nevertheless, any such reform, if adopted, and
ongoing changes in the industry, could adversely affect the pricing of
therapeutic products in the United States or the amount of reimbursement
available from governmental agencies or third-party insurers, and consequently
could have a material adverse effect upon the Company. In both domestic and
foreign markets, sales of the Company's therapeutic products, if any, will
depend in part on the availability of reimbursement from third-party payors,
such as government and private insurance plans and other organizations.
Third-party payors and others increasingly are challenging the prices charged
for medical products and services. There can be no assurance that the Company's
products will be considered cost effective, that reimbursement will be available
or, if available, that the payor's reimbursement policies will not adversely
affect the Company's ability to sell its products on a profitable basis. Other
aspects of the business in which the Company is engaged could also be affected.
The Company cannot predict the outcome of any government or industry reform
initiatives or the impact thereof on the Company's financial position or results
of operations.
COMPETITION
The pharmaceutical industry is subject to rapid and significant
technological change. In the development and marketing of topical prescription
drugs, cosmeceutical and skin care products, and drug delivery systems, Cellegy
faces intense competition. Competitors of the Company in the United States and
abroad are numerous and include, among others, major pharmaceutical, cosmetic,
chemical, consumer product, and biotechnology companies, specialized firms,
universities and other research institutions. There can be no assurance that the
Company's competitors will not succeed in developing technologies and products
that are more effective than any which are being developed by the Company or
that would render the Company's technology and potential products obsolete and
noncompetitive. Many of these competitors have substantially greater financial
and technical resources, production and marketing capabilities and regulatory
experience than the Company. In addition, many of the Company's competitors have
significantly greater experience than the Company in preclinical testing and
human clinical trials of pharmaceutical products and in obtaining FDA and other
regulatory approvals of products for use in health care. The Company also
competes with universities developing drug delivery technologies and with
several companies which have been formed to develop unique delivery systems. In
addition, these companies and academic and research institutions compete with
Cellegy in recruiting and retaining highly qualified scientific and management
personnel.
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<PAGE> 39
Competition in the markets in which the Company expects to compete is
generally based on performance characteristics and, to a lesser extent, price.
There can be no assurance that the Company's products under development will be
able to compete successfully with existing or new commercial products.
EMPLOYEES
As of October 10, 1997, the Company had 13 full-time and three part-time
employees. Eleven of these employees, of whom three are M.D.s and another three
are Ph.D.s, are engaged in research and development. In addition, the Company
utilizes the services of several professional consultants, as well as contract
manufacturing and research organizations to supplement its internal staff's
activities. None of the Company's employees is represented by a labor union. The
Company has experienced no work stoppages and believes that its employee
relations are good.
PROPERTIES
The Company occupies approximately 4,300 square feet at its executive
offices in Foster City, California, located near San Francisco, California. The
Company's lease has a term expiring July 31, 2001. The Company also occupies
approximately 5,600 square feet of research and laboratory facilities in San
Carlos, California under a lease with a term expiring May 31, 1998. The Company
may extend the term for up to a six month period. The Company believes its
current facilities will be adequate for at least the next year, although if
acceptable space becomes available, the Company may attempt to consolidate its
laboratory and administrative operations into a single location.
LEGAL PROCEEDINGS
The Company is not a party to any legal proceedings.
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<PAGE> 40
MANAGEMENT
The executive officers, directors, and other significant employees of the
Company are as follows:
<TABLE>
<CAPTION>
NAME AGE POSITION
- ----------------------------- --- ---------------------------------------------------
<S> <C> <C>
K. Michael Forrest 54 President, Chief Executive Officer, and Director
Carl R. Thornfeldt, M.D. 45 Medical Director and Chairman of the Board
Daniel L. Azarnoff, M.D. 71 Vice President, Clinical and Regulatory Affairs
Michael L. Francoeur, Ph.D. 46 Vice President, Research and Development
A. Richard Juelis 49 Vice President, Finance and Chief Financial Officer
Vivien H.W. Mak, Ph.D. 40 Vice President, Cutaneous Research
Jack L. Bowman(1) 65 Director
Denis R. Burger, Ph.D.(2) 54 Director
Tobi B. Klar, M.D. 42 Director
Alan A. Steigrod(1) 60 Director
Larry J. Wells(2) 54 Director
</TABLE>
- ---------------
(1) Member of the Compensation Committee.
(2) Member of the Audit Committee.
K. Michael Forrest. Mr. Forrest became President, CEO, and a director in
December 1996. From January 1996 to November 1996, he served as a biotechnology
consultant. From November 1994 to December 1995, he served as President and CEO
of Mercator Genetics, a public biotechnology company. From March 1991 to June
1994, he served as President and CEO of Transkaryotic Therapies, Inc., a public
biotechnology company. From 1968 to 1991, Mr. Forrest held a series of positions
with Pfizer, Inc. and senior management positions with American Cyanamid,
including Vice President of the Lederle International Group. He is a director of
AlphaGene Inc.
Carl R. Thornfeldt, M.D. Dr. Thornfeldt is the Chairman of the Board of
Directors and a co-founder of the Company, as well as a physician, board
certified in dermatology. He has been Medical Director of the Company since its
inception. Dr. Thornfeldt served as acting CEO from July 1996 to December 1996.
In addition, Dr. Thornfeldt served as Vice President, Research and Development
from October 1994 until May 1996. Since 1983, Dr. Thornfeldt has maintained a
private dermatology practice and is an Assistant Clinical Professor in
Dermatology at the University of Oregon Health Sciences Center. Dr. Thornfeldt
received his M.D. from the University of Oregon.
Daniel L. Azarnoff, M.D. Dr. Azarnoff became Vice President, Clinical and
Regulatory Affairs in October 1997. Since January 1986, Dr. Azarnoff has been
President of D.L. Azarnoff Associates and will continue consulting to the
industry on a part-time basis. From August 1978 to December 1985, he served as
President of Research and Development at G.D. Searle and Co. From July 1967 to
August 1978, he was KUMC Distinguished Professor of Medicine and Pharmacology,
as well as the Director of the Clinical Pharmacology-Toxicology Center at the
University of Kansas Medical Center. Dr. Azarnoff has also served as a member of
advisory and expert committees within the Food and Drug Administration, World
Health Organization, American Medical Association, National Academy of Sciences
and National Institutes of Health. He received his M.D. from the University of
Kansas Medical School.
Michael L. Francoeur, Ph.D. Dr. Francoeur became Vice President, Research
and Development in June 1996. From March 1994 to May 1996, he was founder,
Chairman and Chief Technical Officer of De Novo, Inc., a dermal therapeutics
company. From September 1992 to March 1994, Dr. Francoeur held senior executive
positions with Pharmetrix, Inc., a drug delivery company, where he led research
and development. From February 1983 to August 1992, he was employed by Pfizer,
Inc., where he held various research and management positions in product
development, drug delivery, and drug discovery. Dr. Francoeur holds a Ph.D. in
pharmaceutical chemistry and a B.S. in pharmacy from the University of Kansas.
39
<PAGE> 41
A. Richard Juelis. Mr. Juelis became Vice President, Finance and Chief
Financial Officer in March 1996. From November 1994 until March 1996, he worked
as a financial consultant to the Company, as well as to other companies. From
January 1993 to September 1994 he served as Vice President, Finance and Chief
Financial Officer for VIVUS, Inc., a publicly traded drug delivery company. From
October 1990 to December 1992, he served as Vice President, Finance and Chief
Financial Officer at XOMA Corporation, a public biotechnology company. Mr.
Juelis has also held domestic and international financial and general management
positions with Hoffmann-LaRoche from 1976 to 1982, and Schering-Plough from 1983
to 1990.
Vivien H.W. Mak, Ph.D. Dr. Mak became Vice President, Cutaneous Research
in January 1996, after joining the Company as a research consultant in October
1995. From January 1994 to September 1995, she served as Vice President,
Research for De Novo, Inc. From October 1992 to December 1993, she was Director
of Biopharmaceutical Sciences at Pharmetrix Corporation, a developer of drug
delivery systems. From January 1989 to September 1992 she held research
scientist positions in the Dermal Therapeutics Group of Pfizer, Inc. Dr. Mak
holds a Ph.D. in medicinal chemistry from Purdue University.
Jack L. Bowman. Mr. Bowman became a director in December 1996. He is
currently a consultant to various pharmaceutical and biotechnology industry
groups. From August 1987 to January 1994, he was Group Chairman at Johnson &
Johnson, where he managed its global pharmaceutical business. Before then, Mr.
Bowman held executive positions with CIBA-Geigy and American Cyanamid, where he
had responsibility for worldwide pharmaceutical, medical device, and consumer
product divisions. He is currently a director of NeoRx Corp., CytRx Corp., Cell
Therapeutics, Inc., Targeted Genetics, Inc. and Osiris Pharmaceuticals, Inc.
Denis R. Burger, Ph.D. Dr. Burger became a director in October 1995.
Currently, he serves as Chief Executive Officer of AntiVirals Inc., a
biotechnology company, and is a general partner of Sovereign Partners LLC, a
biotechnology consulting and merchant banking partnership. He is a director of
SuperGen, Inc. and Trinity Biotech, plc. He was a co-founder of Epitope, Inc.
and served as Chairman from 1981 to 1990. Dr. Burger has also served as a
research scientist and professor of microbiology and immunology at the Oregon
Health Sciences University. He holds an M.S. and Ph.D. degrees in microbiology
and immunology.
Tobi B. Klar, M.D. Dr. Klar became a director of the Company in June 1995.
She is a physician, board certified in dermatology. Since 1986, Dr. Klar has
maintained a private dermatology practice and has served as Co-Chairperson of
the Department of Dermatology at New Rochelle Hospital Medical Center, New
Rochelle, New York, and Associate Clinical Professor in dermatology at Albert
Einstein Medical Center in New York City. Dr. Klar holds an M.D. from the State
University of New York.
Alan A. Steigrod. Mr. Steigrod became a director in July 1996, and has
been a biotechnology industry consultant since December 1995. From March 1993 to
November 1995, he served as President and CEO of Cortex Pharmaceuticals, Inc.
From February 1991 to February 1993, he worked as a biotechnology consultant.
From March 1981 through February 1991, Mr. Steigrod held a series of executive
positions with Glaxo, Inc., serving as Chairman of Glaxo's operating committee,
as well as on its board of directors. As Executive Vice President, he managed
five divisions, including Glaxo Pharmaceuticals and Glaxo Dermatology Products.
Prior to Glaxo, Mr. Steigrod held a number of senior management positions with
Boehringer Ingelheim, Ltd. and Eli Lilly & Co. He is a director of Sepracor Inc.
Larry J. Wells. Mr. Wells became a director of the Company in 1989. For
the past five years, he has been a venture capitalist. He is the founder of
Sundance Venture Partners, L.P. ("Sundance"), a venture capital fund, and is the
Chairman of the managing entity of Sundance. Mr. Wells is a director of Identix,
Inc., Gateway Data Sciences and Telegen Corp.
Directors hold office until the next annual meeting of shareholders and
until their respective successors have been elected and qualified. Executive
officers are chosen by and serve at the discretion of the Board of Directors,
subject to any written employment agreements with the Company.
Standing committees of the Board include an Audit Committee and a
Compensation Committee. Dr. Burger and Mr. Wells are the current members of the
Audit Committee. The Audit Committee reviews the Company's accounting practices,
internal control systems and meets with the Company's outside auditors
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<PAGE> 42
concerning the scope and terms of their engagement and the results of their
audits. Messrs. Bowman and Steigrod are the current members of the Compensation
Committee. The Compensation Committee recommends compensation for officers and
employees of the Company, and grants options and stock awards under the
Company's employee benefit plans.
SCIENTIFIC ADVISORY BOARD
The Company has established relationships with a group of scientific
advisors with expertise in the fields of dermatology, drug delivery and skin
care. The Company's scientific advisors consult with management and key
scientific employees of the Company to assist the Company in identifying
scientific and product development opportunities, to review the progress of the
Company's specific projects, and to recruit and evaluate the Company's
scientific staff. The nature, scope and frequency of consultations between the
Company and each scientific advisor vary depending upon the Company's current
activities, the need for specific assistance and the individual scientific
advisor.
The Company's scientific advisors and consultants include:
Carl R. Thornfeldt, M.D. Dr. Thornfeldt is Co-Chairman of the Scientific
Advisory Board. See "Executive Officers and Directors."
Peter M. Elias, M.D. Dr. Elias is Co-Chairman of the Scientific Advisory
Board. Dr. Elias is a board certified dermatologist and served as a director of
the Company from April 1995 until October 1997. He is an expert in the stratum
corneum barrier, as well as epidermal structure, function and lipid metabolism.
Dr. Elias is currently the Vice-Chairman, Department of Dermatology, University
of California, San Francisco. He received his M.D. from University of
California, San Francisco, and performed his dermatology residency at Harvard
University Medical Center.
Bruce A. Beutler, M.D. Dr. Beutler is a Professor of Internal Medicine and
an Associate Investigator at the Howard Hughes Medical Institute at the
University of Texas Southwestern Medical Center in Dallas. He is best known for
his work related to tumor necrosis factor alpha (TNF) which he originally
isolated and demonstrated to be an essential mediator in shock and other
inflammatory diseases. Dr. Beutler has published numerous articles related to
these subjects, and has lectured extensively on TNF and the role of cytokines in
inflammation. He is an elected member of the American Society for Clinical
Research and the American Society for Hematology. He is also a member of the New
York Academy of Sciences and the American Federation for Clinical Research. He
has received numerous awards and honors including the Young Investigator Award
(American Society for Clinical Research) and the Alexander von Humboldt -
Stiftung Award. Dr. Beutler is also a Consulting and Advisory Editor for the
Journal of Experimental Medicine and the Journal of Clinical Investigation.
Kenneth R. Feingold, M.D. Dr. Feingold is a physician at the VAMC, San
Francisco and is also a professor of Medicine and Dermatology at the University
of California, San Francisco, School of Medicine. Dr. Feingold has performed
extensive research in metabolism, endocrinology and dermatology.
Richard H. Guy, Ph.D. Dr. Guy is the Directeur Scientifique of the Centre
Interuniversitaire de Recherche et d'enseignement (Pharmapeptides), and
Professeur Associe in the Faculte des Sciences at the Universite de Geneve. Dr.
Guy was formerly Professor of Biopharmaceutical Sciences and Pharmaceutical
Chemistry at the University of California, San Francisco, where he continues to
hold a position as Adjunct Professor. Dr. Guy is an elected fellow of the Royal
Society of Chemistry, the American Association of Pharmaceutical Scientists and
the American Association for the Advancement of Science, and serves on the
editorial advisory boards of Advanced Drug Delivery Reviews, the Journal of
Controlled Release, the Journal of Pharmacy & Pharmacology and the European
Journal of Pharmaceutics and Biopharmaceutics.
Kenneth L. Melmon, M.D. Dr. Melmon serves as the Professor of Medicine and
Pharmacology and Associate Dean for Postgraduate Medical Education at Stanford
University School of Medicine. He joined Stanford Medical School in 1978 where
he served as Chairman of the Department of Medicine. Dr. Melmon's work in
Clinical Pharmacology has resulted in the training of numerous fellows at the
University of California, San Francisco and Stanford University School of
Medicine. Dr. Melmon's area of research is directed at the
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<PAGE> 43
pharmacology of the immune response, and in particular he has focused on the
molecular and cellular mechanisms by which mediators of inflammation modulate
and suppress the immune response.
Lester Mitscher, Ph.D. Dr. Mitscher is the University Distinguished
Professor, Department Medicinal Chemistry, University of Kansas, where he
previously served as Chairman. He also currently holds the positions of Adjunct
Professor of Medicinal Chemistry, University of Missouri (Kansas City) and
Adjunct Professor of Microbiology, University of Kansas. Dr. Mitscher is a
member of numerous organizations including the American Chemical Society, where
he served as Chairman of the Medical Chemistry Division, and the American
Society for Pharmacognosy, where he served as Chairman. Dr. Mitscher has
received several awards and honors, such as the Edward E. Smissman Award in the
Biomedical Sciences and is an Elected Fellow for the American Association for
the Advancement of Science. He has published or presented numerous research
papers, authored several books on drug synthesis, and holds twelve U.S. patents
and several foreign patents. His current research interests relate to the
chemistry and mechanisms of medicinals, including anti-oxidants, antibiotics and
anti-inflammatory drugs.
Jim E. Riviere, D.V.M., Ph.D. Dr. Riviere is the Burroughs Wellcome Fund
Distinguished Professor of Pharmacology and Director, Cutaneous Pharmacology and
Toxicology Center, College of Veterinary Medicine, North Carolina State
University. Dr. Riviere is a member of numerous organizations including the U.S.
Pharmacopeia General Committee of Revision, Society of Toxicology, American
Board of Forensic Examiners and the American Veterinary Medical Association. Dr.
Riviere has received the American Pharmaceutical Association's Ebert Prize, the
Harvey W. Wiley Medal and FDA Commissioner's Special Citation in 1997. He has
published or presented numerous research papers and is the holder of four U.S.
patents. His current research interests relate to pharmacokinetics, transdermal
drug delivery and pesticide dermal absorption and metabolism.
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EXECUTIVE COMPENSATION
The following table sets forth all compensation awarded, earned or paid for
services rendered in all capacities to the Company during fiscal years 1994,
1995 and 1996 to (i) each person who served as the Company's chief executive
officer during 1996, (ii) any other executive officers who were serving as
executive officers at the end of 1996 and whose total annual salary and bonus in
such year exceeded $100,000 and (iii) any person who was an executive officer
during a portion of 1996 whose total annual salary and bonus exceeded $100,000,
(together, the "Named Officers").
SUMMARY COMPENSATION TABLE
<TABLE>
<CAPTION>
LONG TERM
ANNUAL COMPENSATION COMPENSATION
-------------------------------------------- SECURITIES
OTHER ANNUAL UNDERLYING ALL OTHER
NAME AND PRINCIPAL SALARY BONUS COMPENSATION OPTIONS COMPENSATION
POSITION YEAR ($) ($) ($) (#) ($)
- --------------------------- ---- ------- ------ ------------ ------------ ------------
<S> <C> <C> <C> <C> <C> <C>
K. Michael Forrest......... 1996 23,103 50,000(2) -- 245,000 --
President and Chief 1995 -- -- -- -- --
Executive Officer(1) 1994 -- -- -- -- --
William E. Bliss........... 1996 154,583 -- -- -- --
President and Chief 1995 21,242 -- 89,512(4) 226,333 --
Executive Officer(3) 1994 -- -- -- -- --
Carl R. Thornfeldt, M.D.... 1996 107,962 -- -- 54,000 --
Medical Director and 1995 97,500 -- -- 70,422 --
Chairman of the Board 1994 76,098 -- -- 4,920 --
Michael L. Francoeur, 1996 147,042 -- -- 81,000 --
Ph.D.....................
VP, Research and 1995 -- -- -- -- --
Development 1994 -- -- -- -- --
A. Richard Juelis.......... 1996 131,830 -- -- 28,500 --
VP, Finance and 1995 103,670 -- -- 55,502 --
Chief Financial Officer 1994 11,108 --
Vivien H.W. Mak, Ph.D...... 1996 115,187 -- -- 40,000 --
VP, Cutaneous Research 1995 22,100 -- -- 7,810 --
1994 -- -- -- -- --
</TABLE>
- ---------------
(1) Mr. Forrest became President and Chief Executive Officer of the Company in
November 1996, following the death of William E. Bliss, President and Chief
Executive Officer.
(2) Consists of a bonus paid on January 31, 1997, in accordance with his
employment agreement. The bonus is being expensed during the period starting
December 1, 1996, and ending December 31, 1997.
(3) Mr. Bliss was President and Chief Executive Officer of the Company from
December 1995 until his death in July 1996.
(4) Consists of Mr. Bliss' relocation compensation accrued when he joined the
Company in December 1995 and paid during 1996.
43
<PAGE> 45
The following table sets forth information regarding individual grants of
options to acquire Common Stock during fiscal 1996 to each Named Officer.
OPTION GRANTS IN LAST FISCAL YEAR
<TABLE>
<CAPTION>
INDIVIDUAL GRANTS
---------------------------------------------------------------------------
NUMBER OF
SECURITIES
UNDERLYING % OF TOTAL OPTIONS EXERCISE OR
OPTIONS GRANTED TO EMPLOYEES BASE PRICE
NAME GRANTED (#) IN FISCAL YEAR ($/SH) EXPIRATION DATE
- ----------------------------- ----------- -------------------- ----------- ------------------
<S> <C> <C> <C> <C>
K. Michael Forrest(1)........ 245,000 47.2% $4.56 November 20, 2006
Carl R. Thornfeldt, 45,000 8.7% $5.64 January 2, 2006
M.D.(2)....................
Carl R. Thornfeldt, M.D...... 9,000 1.7% $4.56 November 20, 2006
Michael L. Francoeur, 75,000 14.4% $7.25 May 22, 2006
Ph.D.(3)...................
Michael L. Francoeur, 6,000 1.2% $4.56 November 20, 2006
Ph.D.......................
A. Richard Juelis(4)......... 19,500 3.8% $5.50 March 26, 2006
A. Richard Juelis............ 9,000 1.7% $4.56 November 20, 2006
Vivien H.W. Mak, Ph.D........ 18,000 3.5% $5.75 March 15, 2006
Vivien H.W. Mak, Ph.D.(5).... 16,000 3.1% $7.25 May 22, 2006
Vivien H.W. Mak, Ph.D........ 6,000 1.2% $4.56 November 20, 2006
</TABLE>
- ---------------
(1) Of the shares subject to this option, 25,000 shares were exercisable at
grant, and 25,000 shares are exercisable after six months following the
grant date. An additional 150,000 shares become exercisable over four years
from the grant date vesting in four equal annual installments, if there has
been no employment termination. The remaining 45,000 shares will become
exercisable at the earlier of the accomplishment of certain milestones or
after five years from the date of grant. The option becomes exercisable in
full upon acquisition of the Company.
(2) Of the shares subject to this option, 22,500 shares were exercisable at
grant. The remaining 22,500 shares are exercisable over a four year period
at a rate of 1/48 per month.
(3) Of the shares subject to this option, 12,750 shares were exercisable at
grant. An additional 37,500 shares become exercisable over four years from
the grant date vesting in four equal annual installments, if there has been
no employment termination. The remaining 24,750 shares will become
exercisable at the earlier of the accomplishment of certain milestones or
after five years from the date of grant.
(4) Of the shares subject to this option, 4,875 shares were exercisable at
grant. The remaining 14,625 shares will become exercisable at the earlier of
the accomplishment of certain milestones or after five years from the date
of grant.
(5) Of the shares subject to this option, 4,000 shares were exercisable at
grant. The remaining 12,000 shares will become exercisable at the earlier of
the accomplishment of certain milestones or after five years from the date
of grant.
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<PAGE> 46
The following table sets forth information with respect to the options
exercised during fiscal 1996 by the Named Officers during fiscal 1996.
AGGREGATED OPTION/SAR EXERCISES IN LAST FISCAL YEAR AND
FY-END OPTION/SAR VALUES
<TABLE>
<CAPTION>
NUMBER OF SECURITIES
UNDERLYING UNEXERCISED VALUE OF UNEXERCISED IN-THE-
OPTIONS/SARS AT MONEY OPTIONS AT
DECEMBER 31, 1996 (#) DECEMBER 31, 1996 ($)
NAME EXERCISABLE/UNEXERCISABLE EXERCISABLE/UNEXERCISABLE(1)
- ---------------------------------------------- ------------------------- -----------------------------
<S> <C> <C>
K. Michael Forrest............................ 25,000/220,000 --
Carl R. Thornfeldt, M.D....................... 27,656/17,344 --
Carl R. Thornfeldt, M.D....................... 0/9,000 --
Michael L. Francoeur, Ph.D.................... 12,750/75,000 --
Michael L. Francoeur, Ph.D.................... 0/6,000 --
A. Richard Juelis............................. 9,750/9,750 --
A. Richard Juelis............................. 0/9,000 --
Vivien H.W. Mak, Ph.D......................... 0/18,000 --
Vivien H.W. Mak, Ph.D......................... 4,000/12,000 --
Vivien H.W. Mak, Ph.D......................... 0/6,000 --
</TABLE>
- ---------------
(1) Based on the difference between the fair market value of the Common Stock at
December 31, 1996 ($4.50 per share) and the exercise price of options shown
in the table. The exercise prices of the options are higher than the fair
market value of the shares at December 31, 1996.
DIRECTOR COMPENSATION
Directors employed by the Company did not receive any monetary fees for
services performed for the Company during 1996. Outside directors are reimbursed
for their travel expenses related to Board meetings and receive a fee of $1,000
for each Board meeting attended in person.
Non-employee directors of the Company are eligible to participate in the
1995 Directors' Stock Option Plan (the "Directors Plan"). A total of 150,000
shares of Common Stock are reserved for issuance to eligible directors pursuant
to the Directors Plan. The Plan is currently administered by the Compensation
Committee of the Board and is intended to qualify for the exemption provided by
Rule 16b-3 under the Exchange Act. On the date on which an eligible director is
elected, the director is granted a non-qualified stock option (normally with a
term of ten years) (an "Initial Option") to acquire 20,000 shares. Thereafter,
on the first business day after the Company's annual meeting of shareholders, an
eligible director will be granted a ten year option (an "Annual Option") to
acquire 1,000 shares. The exercise price of all such options is the fair market
value of the shares on the grant date. Initial Options generally are exercisable
immediately with respect to 25% of the shares subject to the option, and become
exercisable with respect to the remaining shares subject to the option upon the
first, second, third and fourth anniversaries of the grant date. Annual Options
become exercisable with respect to 25% of the shares subject to the option on
each of the first, second, third and fourth anniversaries of the grant date. At
September 30, 1997, options to purchase 76,000 shares of Common Stock were
outstanding under the Directors Plan, 23,750 of which were then currently
exercisable.
EMPLOYMENT AGREEMENTS
Mr. Forrest, President and Chief Executive Officer, and the Company entered
into an employment agreement dated November 20, 1996. The base term of the
agreement is through December 1, 2000. The agreement provides for a base
compensation of $265,000 per year. Either the Company or Mr. Forrest may
terminate the agreement at any time upon notice to the other party. The
agreement provides that, upon termination without cause, Mr. Forrest will be
paid twelve months severance and continuation of benefits during the period
severance payments are made. The agreement provides for the payment of a $50,000
bonus,
45
<PAGE> 47
which was paid to Mr. Forrest upon the effectiveness of the agreement. The
agreement provides for the granting of an option to purchase 245,000 shares of
Common Stock, of which 25,000 shares are fully vested at the date of grant, and
of which 25,000 shares are vested six months after the date of grant. An
additional 45,000 shares issuable upon exercise of the option will vest at the
earlier of the accomplishment of certain milestones or after five years from
date of grant. The remaining 150,000 shares of Common Stock vest over four years
from the grant date (in four equal annual installments) if there has been no
Employment Termination.
Dr. Thornfeldt and the Company entered into an employment agreement dated
January 21, 1996. The base term of the agreement is through December 31, 1999.
The agreement provides for payments of $9,000 per month as long as Dr.
Thornfeldt is devoting at least five business days per month to the affairs of
the Company. If, at any time, Dr. Thornfeldt devotes less than five business
days per month to the Company for two consecutive months, then commencing with
the next month his salary would be reduced to $6,000 per month. Reinstatement of
the $9,000 per month salary will then occur only after Dr. Thornfeldt has
recommenced devoting five business days per month to the affairs of the Company.
The agreement provides for the assignment to the Company, subject to certain
exclusions, of inventions of Dr. Thornfeldt during the term of the agreement.
Under the agreement, he may not engage in any activity that is competitive with
the business of the Company, including, without limitation, acting as a
consultant to any business that competes, directly or indirectly, with the
business of the Company. The agreement may be terminated before expiration of
its term upon certain events, including Dr. Thornfeldt's death, a material
breach of the agreement by the other party or by either party upon prior notice
to the other party.
Mr. Juelis became Vice President, Finance, Chief Financial Officer and
Secretary in March 1996 after consulting with the Company on a part time basis
since November 1994. His agreement with the Company dated May 10, 1996 provides
for a base compensation of $150,000 and for certain stock option grants.
Dr. Francoeur became Vice President, Research and Development in May 1996.
His agreement with the Company dated May 22, 1996 provides for a base
compensation of $150,000 and an initial stock option grant to purchase 75,000
shares, subject to certain vesting provisions.
Dr. Mak became Vice President, Cutaneous Research in January 1996 after
joining the Company initially as a consultant in October 1995. Her agreement
with the Company dated January 1, 1996 provides for a base compensation of
$100,000 per year and for certain stock option grants.
Dr. Azarnoff became Vice President, Clinical and Regulatory Affairs in
October 1997. His agreement with the Company provides that he will devote
approximately 20 hours per week to the affairs of the Company, and provides for
a base compensation of $115,000 per year and for certain stock option grants.
Dr. Elias, who was a director until September 1997 and is Co-Chairman of
the Scientific Advisory Board, entered into a consulting agreement with the
Company dated May 1, 1996, pursuant to which Dr. Elias agreed to provide
consulting services in the fields of dermatology, skin pharmacology and drug
development not less than two days per month. The agreement provides for
consulting fees of approximately $3,500 per month.
CERTAIN TRANSACTIONS
In August 1997, the Company agreed with Dr. Francoeur and Dr. Mak to cancel
a portion of certain stock options they held to acquire 60,000 and 12,000 shares
at an exercise price of $7.25 per share, in consideration of the grant of new
stock options to acquire 60,000 and 12,000 shares at an exercise price of $3.75
per share. This price represented the fair market value of the Common Stock on
the date of grant. The new options were exercisable with respect to the same
number of shares of Common Stock that were exercisable under the old options,
but vesting with respect to the remainder of the new options began on the grant
date of the new options.
See "Employment Agreements."
46
<PAGE> 48
PRINCIPAL SHAREHOLDERS
The following table sets forth, as of October 10, 1997, certain information
known to the Company regarding the ownership of shares of Common Stock by (i)
each person known to the Company to be a beneficial owner of more that 5% of the
outstanding shares of Common Stock, (ii) each director, (iii) each Named Officer
(see "Executive Compensation"), and (iv) all directors and executive officers as
a group. Except as set forth below, the address of each named individual is the
address of the Company.
<TABLE>
<CAPTION>
PERCENTAGE OWNERSHIP
SHARES ------------------------
NAME OF BENEFICIAL OWNER OR GROUP BENEFICIALLY BEFORE THE AFTER THE
AND NATURE OF BENEFICIAL OWNERSHIP OWNED(1) OFFERING OFFERING
- ------------------------------------------------------------ ------------ ---------- ---------
<S> <C> <C> <C>
Four Partners............................................... 1,053,500 13.9% 10.7%
667 Madison Avenue
New York, New York 10021
Sundance Venture Partners, L.P.............................. 583,482 7.7% 5.9%
10600 N. DeAnza Boulevard, Suite 215
Cupertino, California 95014
Biotechnology Value Fund.................................... 490,560 6.5% 5.0%
333 W. Wacker Drive, Suite 1600
Chicago, Illinois 60606
Larry J. Wells(2)........................................... 597,794 7.9% 6.1%
10600 N. DeAnza Boulevard, Suite 215
Cupertino, California 95014
K. Michael Forrest(3)....................................... 463,327 6.0% 4.7%
Carl R. Thornfeldt, M.D.(4)................................. 460,618 6.0% 4.6%
A. Richard Juelis(5)........................................ 53,627 * *
Michael L. Francoeur, Ph.D.(6).............................. 23,625 * *
Vivien H.W. Mak, Ph.D.(7)................................... 21,810 * *
Denis R. Burger, Ph.D.(8)................................... 13,375 * *
Alan A. Steigrod(9)......................................... 11,375) * *
Tobi B. Klar, M.D.(10)...................................... 7,710 * *
Jack L. Bowman(11).......................................... 7,500 * *
All directors and executive officers as a group
(11 persons)(12).......................................... 1,660,761 21.0% 16.4%
</TABLE>
- ---------------
* Less than one percent.
(1) Based upon information supplied by officers, directors and principal
shareholders. Beneficial ownership is determined in accordance with rules
of the Securities and Exchange Commission that deem shares to be
beneficially owned by any person who has or shares voting or investment
power with respect to such shares. Unless otherwise indicated, the persons
named in this table have sole voting and sole investing power with respect
to all shares shown as beneficially owned, subject to community property
laws where applicable. Shares of Common Stock subject to an option that is
currently exercisable or exercisable within 60 days of October 10, 1997 are
deemed to be outstanding and to be beneficially owned by the person holding
such option for the purpose of computing the percentage ownership of such
person but are not treated as outstanding for the purpose of computing the
percentage ownership of any other person.
(2) Includes 583,482 shares held by Sundance Venture Partners, L.P., of which
Mr. Wells may be deemed a beneficial owner. Includes 4,736 shares issuable
upon exercise of presently exercisable common stock purchase warrants.
Includes 9,576 shares subject to stock options exercisable before December
10, 1997.
(3) Includes 87,500 shares subject to stock options exercisable before December
10, 1997.
47
<PAGE> 49
(4) Excludes 38,223 and 38,126 shares, respectively, held in trust for two
relatives of Dr. Thornfeldt and a total of 14,174 shares held by other
relatives with respect to which Dr. Thornfeldt has no voting control.
Includes 75,663 shares subject to stock options exercisable before December
10, 1997. Includes 190,463 shares held by Dr. Thornfeldt's spouse.
(5) Includes 53,627 shares subject to stock options exercisable before December
10, 1997.
(6) Includes 23,625 shares subject to stock options exercisable before December
10, 1997.
(7) Includes 21,810 shares subject to stock options exercisable before December
10, 1997.
(8) Includes 13,375 shares subject to stock options exercisable before December
10, 1997.
(9) Includes 9,375 shares subject to stock options exercisable before December
10, 1997.
(10) Includes 7,710 shares subject to stock options exercisable before December
10, 1997.
(11) Includes 5,000 shares subject to stock options exercisable before December
10, 1997.
(12) Includes 307,261 shares subject to stock options exercisable before
December 10, 1997. Includes 583,482 shares held by Sundance Venture
Partners, L.P., of which Mr. Wells may be deemed a beneficial owner.
Includes 4,736 shares issuable upon exercise of presently exercisable
common stock purchase warrants.
EMPLOYEE BENEFIT PLANS
The Company's 1995 Equity Incentive Plan (the "Incentive Plan") was
approved by the Board and the Company's shareholders effective August 1995. A
total of 1,450,000 shares of Common Stock are reserved for issuance under the
Incentive Plan. The Incentive Plan provides for the award of options, which may
either be incentive stock options ("ISOs") within the meaning of Section 422A of
the Internal Revenue Code of 1986 (the "Code") or non-qualified options ("NQOs")
which are not subject to special tax treatment under the Code. The Incentive
Plan also provides for the award of stock bonuses and restricted stock. The
Incentive Plan is administered by the Board or a committee appointed by the
Board (the "Administrator"). Directors, officers and employees of, and
consultants to, the Company or any parent or subsidiary corporation selected by
the Administrator are eligible to receive options under the Incentive Plan.
Subject to certain restrictions, the Administrator is authorized to designate
the number of shares to be covered by each award, the terms of the award, the
dates on which and the rates at which options or other awards may be exercised,
the method of payment and other terms.
ISOs cannot be less than the fair market value of the stock subject to the
option on the grant date and the exercise price of a NQO may not be less than
85% of such value. Unless the Administrator determines otherwise, options
generally have a 10-year term (or five years in the case of ISOs granted to a
participant owning more than 10% of the total voting power of the Company's
stock). Unless the Administrator provides otherwise, options terminate upon the
termination of a participant's employment, except that the participant may
exercise an option for a certain period of time after termination.
Generally, awards must be exercised by cash payment to the Company of the
exercise price. However, the Administrator may allow a participant to pay all or
a portion of the exercise price by means of a promissory note, stock or other
lawful consideration. The Incentive Plan also allows the Administrator to
provide for withholding and employment taxes payable by a participant to the
Company upon exercise of an award by delivery of a promissory note or
already-owned Common Stock, or by withholding shares acquired upon exercise of
the award. Additionally, the Company may make cash grants or loans to
participants relating to the participant's withholding and employment tax
obligations and the income tax liability incurred by a participant upon exercise
of an award.
See "Director Compensation" For a description of the Directors Plan.
INDEMNIFICATION OF DIRECTORS AND EXECUTIVE OFFICERS AND LIMITATION OF LIABILITY
The Company's Amended and Restated Articles of Incorporation (the "Restated
Articles") include a provision that eliminates the personal liability of its
directors to the Company and its shareholders for monetary damages for breach of
the directors' fiduciary duties to the maximum extent permitted under California
law. This limitation has no effect on a director's liability (i) for acts or
omissions that involve
48
<PAGE> 50
intentional misconduct or a knowing and culpable violation of law, (ii) for acts
or omissions that a director believes to be contrary to the best interests of
the Company or its shareholders or that involve the absence of good faith on the
part of the director, (iii) for any transaction from which a director derived an
improper personal benefit, (iv) for acts or omissions that show a reckless
disregard for the director's duty to the Company or its shareholders in
circumstances in which the director was aware, or should have been aware, in the
ordinary course of performing a director's duties, of a risk of a serious injury
to the Company or its shareholders, (v) for acts or omissions that constitute an
unexcused pattern of inattention that amounts to an abdication of the director's
duty to the Company or its shareholders, (vi) under Section 310 of the
California Corporations Code (the "California Code") (concerning contracts or
transactions between the Company and a director) or (vii) under Section 316 of
the California Code (concerning directors' liability for improper dividends,
loans and guarantees). The provision does not extend to acts or omissions of a
director in his capacity as an officer. Further, the provision has no effect on
claims arising under federal or state securities laws and will not affect the
availability of injunctions and other equitable remedies available to the
Company's shareholders for any violation of a director's fiduciary duty to the
Company or its shareholders.
The Restated Articles also include an authorization for the Company to
indemnify its agents (as defined in Section 317 of the California Code), through
bylaw provisions, by agreement or otherwise, to the fullest extent permitted by
law. Pursuant to this latter provision, the Company's Bylaws provide for
indemnification of the Company's directors, officers and employees.
Indemnification may only be authorized by a majority of Company's directors or
shareholders or by order of a court, unless the agent has been successful on the
merits. In addition, the Company's policy is to enter into indemnification
agreements with each of its officers and directors. These indemnification
agreements provide that directors and officers will be indemnified and held
harmless to the fullest extent permitted by law. These agreements, together with
the Restated Articles, may require the Company, among other things, to indemnify
such directors, officers and employees against certain liabilities that may
arise by reason of their status or service as directors or officers (other than
liabilities resulting from willful misconduct of a culpable nature), to advance
expenses to them as they are incurred, provided that they undertake to repay the
amount advanced if it is ultimately determined by a court that they are not
entitled to indemnification, and to obtain directors' and officers' insurance if
available on reasonable terms.
Section 317 of the California Code makes provisions for the indemnification
of officers, directors and other corporate agents in terms sufficiently broad to
indemnify such persons, under certain circumstances, for liabilities (including
reimbursement of expenses incurred) arising under the Securities Act.
The Underwriting Agreement referred to below sets forth certain provisions
with respect to the indemnification of the Company and certain directors,
officers, and controlling persons against certain losses and liabilities,
including certain liabilities under the Securities Act.
Certain of the registration rights agreements that the Company has entered
into with certain of its security holders provide for cross indemnification of
certain holders of the Company's securities with respect to registration
statements filed under the Securities Act with respect to securities held by
such holders, and of the Company and its officers and directors for certain
liabilities existing under the Securities Act and otherwise.
The Company also maintains a director and officer liability policy.
49
<PAGE> 51
DESCRIPTION OF CAPITAL STOCK
The authorized capital stock of the Company consists of 20,000,000 shares
of Common Stock and 5,000,000 shares of Preferred Stock. As of October 10, 1997,
there were 7,594,959 shares of Common Stock outstanding held of record by
approximately 96 shareholders, and no outstanding shares of Preferred Stock. In
the Company's initial public offering in August 1995, the Company sold 661,250
units ("Units"), each Unit consisting of two shares of Common Stock and one
warrant to purchase one share of Common Stock (the "IPO Warrants"). The Units
separated immediately and only the Common Stock and IPO Warrants trade on the
Nasdaq SmallCap Market. If the Company's Common Stock and IPO Warrants are
approved for quotation on the Nasdaq National Market, the Common Stock and IPO
Warrants will trade on the Nasdaq National Market after the completion of this
Offering.
COMMON STOCK
Subject to preferences that may be applicable to any outstanding Preferred
Stock, the holders of outstanding shares of Common Stock are entitled to receive
dividends out of assets legally available therefor at such times and in such
amounts as the Board may, from time to time, determine. Each shareholder is
entitled to one vote for each share of Common Stock held of record on all
matters submitted to a vote of shareholders. The Company's bylaws provide that
so long as the Company is a "listed company" as defined by applicable California
law, there will not be cumulative voting in connection with the election of
directors. If the Company's Common Stock is approved for trading on the Nasdaq
National Market after completion of this Offering, the Company will be a listed
company as so defined, and therefore cumulative voting will no longer apply in
connection with the election of directors. Holders of Common Stock have no
preemptive rights or rights to convert their Common Stock into any other
securities under the Company's charter documents. There are no redemption or
sinking fund provisions applicable to the Common Stock. Upon liquidation,
dissolution or winding up of the Company, the assets legally available for
distribution to shareholders are distributable ratably among the holders of the
Common Stock outstanding at that time after payment of liquidation preferences,
if any, on any outstanding Preferred Stock and payment of claims of creditors.
All outstanding shares of Common Stock are fully paid and nonassessable.
PREFERRED STOCK
General
The Company's Restated Articles provide that the Company may issue shares
of Preferred Stock in one or more series. The Board of Directors is authorized
to establish from time to time the number of shares to be included in, and the
designation of, any such series, to determine or alter the rights, preferences,
privileges and restrictions granted to or imposed upon any wholly unissued
series of Preferred Stock, and to increase or decrease the number of shares of
any such series (but not below the number of shares of such series then
outstanding) without any further vote or action by the shareholders. The
issuance of Preferred Stock may have the effect of delaying, deferring or
preventing a change in control of the Company without further action by the
shareholders. The issuance of Preferred Stock with voting and conversion rights
may adversely affect the voting power or other rights of the holders of Common
Stock. The Company has no present plans as of the date of this Prospectus to
issue any shares of Preferred Stock.
WARRANTS
Underwriter Warrant
In connection with the Offering, the Company has issued to the Underwriter
Warrant for nominal consideration, entitling the Underwriter to purchase shares
of Common Stock equal to five percent (5%) of the shares of Common Stock sold in
the Offering subject to a maximum of 125,000 warrants at a price per share equal
to 130% of the average closing price of the Common Stock for the five trading
days before the pricing of the shares offered hereby. The Underwriter Warrant is
exercisable for a period of four years, commencing one year following the
closing of this Offering and contains certain demand and piggyback registration
rights with respect to the Common Stock issuable upon the exercise of the
Underwriter Warrant.
50
<PAGE> 52
The Underwriter Warrant is not transferable (except to certain employees and
affiliates of the Underwriter). The exercise price and the number of shares
issuable upon exercise may, under certain circumstances, be subject to
adjustment pursuant to antidilution provisions.
Representatives' Warrants
In connection with the Company's initial public offering, the Company
issued 57,500 Representatives' Warrants and has reserved 172,500 shares of
Common Stock for issuance upon exercise of such warrants (including the warrants
issuable upon exercise of the Representatives' Warrants). Each Representatives'
Warrant entitles the holder to acquire, at an exercise price of $20.63 per Unit,
two shares of Common Stock and a warrant to acquire one share of Common Stock at
an exercise price equal to $10.31. The other terms of the Representatives'
Warrants are substantially similar to the IPO Warrants, except that the
Representatives' Warrants (and the warrants included therein) are not publicly
tradeable and are not redeemable by the Company. The Representatives' Warrants
are exercisable until August 11, 2000.
The IPO Warrants
Each IPO Warrant entitles the holder to purchase one share of Common Stock
at a price of $9.375 per share. The IPO Warrants are, subject to certain
conditions, exercisable at any time from August 11, 1996 until August 11, 2000,
unless earlier redeemed. The IPO Warrants are redeemable by the Company, at $.05
per IPO Warrant, upon 30 days' notice at any time after August 11, 1996 (and
sooner with the consent of either Paulson Investment Company, Inc. or National
Securities Corporation, the underwriters of the Company's initial public
offering) if the closing price per share of the Common Stock for 10 consecutive
trading days ending on a date within 30 business days preceding the date notice
of redemption is given equals or exceeds $12.50. If the Company gives notice of
its intention to redeem, a holder would be forced either to exercise his or her
IPO Warrant before the date specified in the redemption notice or accept the
redemption price. The IPO Warrants were issued in registered form under a
Warrant Agreement (the "Warrant Agreement") between the Company and First
Interstate Bank of California, San Francisco, California, as warrant agent (the
"Warrant Agent").
Other Warrants
At various times before the date of this Prospectus, the Company has issued
warrants to acquire a total of 659,561 shares of Common Stock at various
exercise prices ranging from $0.01 to $9.02 per share, with a weighted average
exercise price of $6.68 per share.
As long as the above warrants are exercisable, the holders thereof have the
opportunity to profit from a rise in the market price of the Common Stock
without assuming the risk of ownership of the shares of Common Stock issuable
upon the exercise of the warrants, with a resulting dilution in the interests of
the Company's shareholders by reason of exercise of warrants at a time when the
exercise price is less than the market price for the Common Stock. Further, the
terms on which the Company could obtain additional capital during the life of
the warrants may be adversely affected. The warrant holders may be expected to
exercise their warrants at a time when the Company would, in all likelihood, be
able to obtain any needed capital by an offering of Common Stock on terms more
favorable than those provided for by the warrants.
REGISTRATION RIGHTS
The Company has granted registration rights at various times in the past in
connection with certain prior issuances of Common Stock and warrants. Pursuant
to the Company's Amended and Restated Registration Rights Agreement dated as of
April 16, 1992, as amended (the "1992 Registration Agreement"), the Company
filed a registration statement on Form S-3 to register the sale, from time to
time, of approximately 6,800,000 shares of Common Stock, including 5,966,250
outstanding shares and 833,750 shares issuable upon the exercise of certain
warrants. Holders of registration rights under the 1992 Registration Agreement
also have piggyback registration rights, subject to certain marketing and other
limitations. The Company is required to bear all registration expenses, other
than underwriting discounts and selling commissions, incurred
51
<PAGE> 53
in connection with the registration of Registrable Shares in one demand
registration, one Form S-3 registration and all Company registrations.
Pursuant to a registration rights agreement with the holders of certain
warrants (the "Bridge Registration Rights Agreement"), the Company has filed a
registration statement on Form S-3 covering the issuance of shares of common
stock (the "Bridge Warrant Shares") issuable upon exercise of the warrants or
the resale of Bridge Warrant Shares that are "Registrable Securities" as defined
in the Bridge Registration Rights Agreement, to cause such registration
statement to become effective, and to keep the registration statement effective
until the earlier to occur of (i) the resale of Warrant Shares, (ii) two years
after the effective date of such registration statement, or (iii) with respect
to any particular holder, at such time as all of the registered Warrant Shares
held by such holder may be publicly resold pursuant to Rule 144 or otherwise
under the Securities Act within the succeeding six months without regard to the
volume of trading in the Company's securities.
The Representatives' Warrants provide certain rights with respect to the
registration under the Securities Act of the 172,500 shares issuable upon
exercise thereof (including the warrants included therein). The Company has
registered the issuance of such shares upon the exercise of the Representatives'
Warrants (and, if necessary, their resale) so as to permit their public resale
without restriction.
In connection with the issuance of 1,547,827 shares of Common Stock in a
private placement transaction in July 1997, the Company agreed to file a
registration statement covering the resale from time to time of the purchased
shares, as well as certain other shares of Common Stock held by such purchasers.
Such a registration statement has been filed and declared effective.
Pursuant to the Underwriter Warrant, the Company has granted to the
Underwriter certain demand and piggyback registration rights with respect to the
Common Stock issuable upon exercise of the Underwriter's Warrants.
TRANSFER AGENT AND REGISTRAR
The Transfer Agent and Registrar for the Company's Common Stock and the IPO
Warrants is ChaseMellon Shareholder Services.
LISTING
The Company has applied to list its Common Stock and the IPO Warrants on
the Nasdaq National Market under the trading symbols "CLGY" and "CLGYW,"
respectively.
SHARES ELIGIBLE FOR FUTURE SALE
Upon completion of this offering, the Company will have outstanding an
aggregate of 9,844,959 shares of Common Stock (based upon shares outstanding at
September 30, 1997), assuming no exercise of the Underwriter's over-allotment
option and no exercise of outstanding options or warrants. Of these shares, the
1,150,000 shares sold in the Company's initial public offering, and all of the
2,250,000 shares sold in this Offering, will be freely tradable without
restriction or further registration under the Securities Act, unless such shares
are held by "affiliates" of the Company as that term is defined in Rule 144
under the Securities Act (the "Affiliates"). The remaining 2,892,824 shares of
Common Stock held by existing shareholders are "restricted securities" as that
term is defined in Rule 144 under the Securities Act ("Restricted Shares").
Restricted Shares may be sold in the public market only if registered or if they
qualify for an exemption from registration under Rule 144 or 701 promulgated
under the Securities Act, which rules are summarized below. Except for the
1,547,827 shares of Common Stock sold in a July 1997 private placement
transaction, substantially all of the outstanding Restricted Securities
satisfied the one-year holding period of Rule 144 and thus may be publicly sold
in compliance with the provisions of Rule 144. A substantial majority of such
outstanding securities have also satisfied the two-year holding period of Rule
144(k) and thus may be sold by persons who are not affiliates of the Company
pursuant to the provisions of Rule 144(k) without regarding to the volume and
other limitations of Rule 144. In addition, the Company has filed registration
statements
52
<PAGE> 54
registering the sale from time to time of certain of such Restricted Securities,
as well as other shares of Common Stock that are issuable upon the exercise of
certain options and warrants. The Company's directors, executive officers and
certain other shareholders who in the aggregate hold approximately 2,362,344
shares of Common Stock have agreed not to offer, pledge, sell, contract to sell,
sell any option or contract to purchase, purchase any option or contract to
sell, grant any option, right or warrant to purchase, or otherwise transfer or
dispose of, directly or indirectly (or enter into any swap or other arrangement
that transfers to another, in whole or in part, any of the economic consequences
of ownership of), any shares of Common Stock or any securities convertible into
or exercisable or exchangeable for shares of Common Stock, for a period of 90
days after the date of this Prospectus, without the prior written consent of the
Underwriter.
In general, under Rule 144 as currently in effect, a person (or persons
whose shares are aggregated) who has beneficially owned Restricted Shares for at
least one year (including the holding period of any prior owner except an
Affiliate) would be entitled to sell within any three-month period a number of
shares that does not exceed the greater of: (i) 1% of the number of shares of
Common Stock then outstanding (which will equal approximately 9,844,959 shares
immediately after this Offering); or (ii) the average weekly trading volume of
the Common Stock on the Nasdaq National Market during the four calendar weeks
preceding the filing of a notice on Form 144 with respect to such sale. Sales
under Rule 144 are also subject to certain manner of sale provisions and notice
requirements and to the availability of current public information about the
Company. Under Rule 144(k), a person who is not deemed to have been an Affiliate
of the Company at any time during the 90 days preceding a sale, and who has
beneficially owned the shares proposed to be sold for at least two years
(including the holding period of any prior owner except an Affiliate), is
entitled to sell such shares without complying with the manner of sale, public
information, volume limitation or notice provisions of Rule 144; therefore,
unless otherwise restricted, "144(k) shares" may be sold immediately upon the
completion of this Offering. In general, under Rule 701 of the Securities Act as
currently in effect, any employee, consultant or advisor of the Company who
purchases shares from the Company before the Company's initial public offering
in connection with a compensatory stock or option plan or other written
agreement may resell such shares in reliance on Rule 144, but without compliance
with certain restrictions, including the holding period, contained in Rule 144.
53
<PAGE> 55
UNDERWRITING
Subject to the terms and conditions of an underwriting agreement (the
"Underwriting Agreement"), the Company has agreed to sell to Oppenheimer & Co.,
Inc. (the "Underwriter"), and the Underwriter has agreed to purchase from the
Company, 2,250,000 shares of Common Stock.
The Underwriter proposes to offer the shares of Common Stock directly to
the public at the public offering price set forth on the cover page of this
Prospectus. The Underwriting Agreement provides that the obligations of the
Underwriter thereunder are subject to approval of certain legal matters by
counsel and of various other conditions. The Underwriter is obligated to take
and pay for all of the shares of Common Stock offered hereby (other than those
covered by the over-allotment option described below) if any are taken.
The Company has granted to the Underwriter a 30-day over-allotment option
to purchase up to 337,500 additional shares of Common Stock at the public
offering price less the underwriting discount. The Underwriter may exercise such
option only to cover over-allotments made in connection with the sale of the
shares of Common Stock offered hereby.
The Company has also agreed to sell to the Underwriter, for nominal
consideration, warrants (the "Underwriter Warrant") to purchase Common Stock
equal to five percent (5%) of the shares of Common Stock sold in the Offering,
subject to a maximum of 125,000 warrants at a price per share equal to 130% of
the average closing price of the Common Stock for the five trading days before
the pricing of the shares of Common Stock offered hereby. The Underwriter
Warrant will be exercisable for a period of four years, commencing one year
following the closing of this offering and will contain certain demand and
piggyback registration rights with respect to the Common Stock issuable upon the
exercise of the Underwriter Warrant. The Underwriter Warrant is not transferable
except to certain employees and affiliates of the Underwriter. The exercise
price and the number of shares issuable upon exercise may, under certain
circumstances, be subject to adjustment pursuant to antidilution provisions.
The Company has agreed to indemnify the Underwriter against certain
liabilities, including, without limitation, liabilities under the Securities
Act, and to contribute to payments that the Underwriter may be required to make
in respect thereof. The Company has also agreed to reimburse the Underwriter for
certain out-of-pocket expenses incurred in connection with the Offering.
In connection with the Offering, the Underwriter and its affiliates may
engage in transactions that stabilize, maintain or otherwise affect the market
price of the Common Stock. Such transactions may include stabilization
transactions effected in accordance with Rule 104 of Regulation M, pursuant to
which such persons may bid for or purchase Common Stock for the purpose of
stabilizing its market price. The Underwriter also may create a short position
for its account by selling more shares of Common Stock in connection with the
Offering than it is committed to purchase from the Company, and in such case may
purchase Common Stock in the open market following completion of the Offering to
cover all or a portion of such short position. The Underwriter may also cover
all or a portion of such short position, up to 337,500 shares of Common Stock,
by exercising the Underwriter's over-allotment option referred to above. Any of
the transactions described in this paragraph may result in the maintenance of
the price of the Common Stock at a level above that which might otherwise
prevail in the open market. None of the transactions described in this paragraph
is required, and, if they are undertaken, they may be discontinued at any time.
The Company's executive officers, directors and certain shareholders who,
after giving effect to the Offering, will collectively own an aggregate of
approximately 2,362,344 shares of Common Stock, have agreed that they will not
directly or indirectly, sell, offer, contract to sell, make a short sale, pledge
or otherwise dispose of any shares of Common Stock (or any securities
convertible into or exchangeable or exercisable for any other rights to purchase
or acquire shares of Common Stock other than shares of Common Stock issuable
upon exercise of outstanding options) owned by them, for a period of 90 days
after the date of this Prospectus, without the prior written consent of the
Underwriter, subject to certain limited exceptions. The Company has also agreed
not to issue, sell or register with the Commission, or otherwise dispose of,
directly or indirectly, any equity securities of the Company (or any securities
convertible into or exercisable or exchangeable for equity securities of the
Company) for a period of 90 days after the date of this Prospectus, without the
prior written
54
<PAGE> 56
consent of the Underwriter, subject to certain limited exceptions. The
Underwriter may, in its sole discretion, and at any time without notice, release
all or any portion of the securities subject to the lock-up agreements.
The Underwriter has advised the Company that it does not intend to make
sales to discretionary accounts.
LEGAL MATTERS
The validity of the issuance of the shares of Common Stock offered hereby
will be passed upon for the Company by Fenwick & West LLP, Palo Alto,
California. Certain matters will be passed upon for the Underwriter by Cooley
Godward LLP, Palo Alto, California.
EXPERTS
The financial statements of Cellegy Pharmaceuticals, Inc. as of December
31, 1995 and 1996 and for each of the three years in the period ended December
31, 1996 and for the period from June 26, 1989 (inception) through December 31,
1996 appearing in the Prospectus and Registration Statement have been audited by
Ernst & Young LLP, independent auditors, as set forth in their report thereon
appearing elsewhere herein and in the Registration Statement and are included in
reliance upon such report given upon the authority of such firm as experts in
accounting and auditing.
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the Exchange
Act, and, in accordance therewith, files reports, proxy statements and other
information with the Securities and Exchange Commission (the "Commission"). Such
reports, proxy statements and other information filed by the Company can be
inspected and copied at the public reference facilities of the Commission
located at Room 1024, Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C.
20549, and at the Commission's regional offices at Seven World Trade Center,
13th Floor, New York, New York 10048; and Northwestern Atrium Center, 500 West
Madison Street, Suite 1400, Chicago, Illinois 60661-2511. Copies of such
material can also be obtained from the Public Reference Section of the
Commission at Room 1024, Judiciary Plaza, 450 Fifth Street, N.W., Washington,
D.C. 20549 at prescribed rates. The Commission also maintains a World Wide Web
site (located at http://www.sec.gov) that contains reports, proxy and
information statements and other information regarding the Company. The
Company's Common Stock is listed on the Nasdaq SmallCap Market and reports,
proxy statements and other information concerning the Company may be inspected
at the offices of the Nasdaq Stock Market, 1735 K Street, N.W., Washington, D.C.
20006-1500.
The Company has filed with the Commission a Registration Statement on Form
S-1 under the Securities Act with respect to the Shares offered hereby. This
Prospectus does not contain all of the information set forth in the Registration
Statement and the exhibits thereto. For further information with respect to the
Company and the Common Stock offered hereby, reference is made to the
Registration Statement and the exhibits filed therewith or incorporated therein
by reference. Statements contained in this Prospectus as to the contents of any
contract or any other document referred to herein are not necessarily complete,
and in each instance reference is made to the copy of such contract or other
document filed as an exhibit to the Registration Statement or incorporated
therein by reference, each such statement being qualified in all respects by
such reference. A copy of the Registration Statement may be inspected, without
charge, at the offices of the Commission in Washington, D.C. and copies of all
or any part of the Registration Statement may be obtained from the Public
Reference Section of the Commission at Room 1024, Judiciary Plaza, 450 Fifth
Street, N.W., Washington, D.C. 20549, upon the payment of the fees prescribed by
the Commission.
55
<PAGE> 57
INDEX TO FINANCIAL STATEMENTS
<TABLE>
<CAPTION>
PAGE
-----
<S> <C>
Report of Ernst & Young LLP, Independent Auditors.................................... F-2
Balance Sheets....................................................................... F-3
Statements of Operations............................................................. F-4
Statements of Shareholders' Equity (Deficit)......................................... F-5
Statements of Cash Flows............................................................. F-7
Notes to Financial Statements........................................................ F-9
</TABLE>
F-1
<PAGE> 58
REPORT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
The Board of Directors and Shareholders
Cellegy Pharmaceuticals, Inc.
We have audited the accompanying balance sheets of Cellegy Pharmaceuticals, Inc.
(a development-stage company) as of December 31, 1995 and 1996, and the related
statements of operations, shareholders' equity (deficit), and cash flows for
each of the three years in the period ended December 31, 1996, and for the
period from June 26, 1989 (inception) through December 31, 1996. These financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Cellegy Pharmaceuticals, Inc.
at December 31, 1995 and 1996, and the results of its operations and its cash
flows for each of the three years in the period ended December 31, 1996, and for
the period from June 26, 1989 (inception) through December 31, 1996, in
conformity with generally accepted accounting principles.
ERNST & YOUNG LLP
San Jose, California
February 5, 1997
F-2
<PAGE> 59
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
BALANCE SHEETS
ASSETS
<TABLE>
<CAPTION>
DECEMBER 31, SEPTEMBER
--------------------------- 30,
1995 1996 1997
----------- ----------- -----------
(UNAUDITED)
<S> <C> <C> <C>
Current assets:
Cash and cash equivalents......................... $ 2,320,130 $ 36,453 $ 1,338,344
Short-term investments............................ 1,500,000 5,255,668 4,974,533
Other current assets.............................. 149,040 350,561 448,130
---------- ---------- ----------
Total current assets................................ 3,969,170 5,642,682 6,761,007
Property and equipment, net......................... 58,665 31,281 16,025
Long-term investments............................... -- 2,022,499 3,063,864
---------- ---------- ----------
Total assets........................................ $ 4,027,835 $ 7,696,462 $ 9,840,896
========== ========== ==========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities.......... $ 192,232 $ 270,013 $ 181,978
Deferred revenue.................................. -- -- 500,000
Accrued research fees............................. -- 21,000 21,000
Accrued compensation and related expenses......... 187,266 17,958 24,413
---------- ---------- ----------
Total current liabilities........................... 379,498 308,971 727,391
Shareholders' equity:
Preferred stock, no par value; 5,000,000 shares
authorized:
Series A convertible preferred stock; 1,100
shares designated; no shares issued or
outstanding at December 31, 1995 and 195 shares
issued and outstanding at December 31, 1996 (no
shares issued and outstanding at September 30,
1997 -- unaudited)............................. -- 2,161,271 --
Common stock, no par value; 20,000,000 shares
authorized: 3,777,075 shares issued and
outstanding at December 31, 1995 and 5,152,752
shares issued and outstanding at December 31,
1996 (7,594,959 shares issued and outstanding
at September 30, 1997 -- unaudited)............ 13,803,793 20,141,370 26,495,852
Unrealized gain on investments.................... -- 22,167 48,398
Deficit accumulated during the development
stage.......................................... (10,155,456) (14,937,317) (17,430,745)
---------- ---------- ----------
Total shareholders' equity........................ 3,648,337 7,387,491 9,113,505
---------- ---------- ----------
Total liabilities and shareholders' equity.......... $ 4,027,835 $ 7,696,462 $ 9,840,896
========== ========== ==========
</TABLE>
See accompanying notes.
F-3
<PAGE> 60
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
STATEMENTS OF OPERATIONS
<TABLE>
<CAPTION>
PERIOD FROM PERIOD FROM
JUNE 26, 1989 JUNE 26, 1989
(INCEPTION) NINE MONTHS ENDED (INCEPTION)
YEARS ENDED DECEMBER 31, THROUGH SEPTEMBER 30, THROUGH
--------------------------------------- DECEMBER 31, ------------------------- SEPTEMBER 30,
1994 1995 1996 1996 1996 1997 1997
----------- ----------- ----------- ------------- ----------- ----------- -------------
(UNAUDITED) (UNAUDITED)
<S> <C> <C> <C> <C> <C> <C> <C>
Revenues:
Licensing and contract
revenue from affiliate... $ -- $ 1,000,000 $ 15,000 $ 1,145,373 $ 15,000 $ -- $ 1,145,373
Licensing, milestone, and
development funding...... -- -- 559,157 559,157 -- 516,656 1,075,813
Government grants.......... -- -- 73,503 73,503 -- 126,498 200,001
----------- ----------- ----------- ----------- ----------- ----------- -----------
Total revenues............... -- 1,000,000 647,660 1,778,033 15,000 643,154 2,421,187
Operating expenses:
Research and development... 1,510,478 1,224,841 2,712,008 9,122,229 1,865,673 2,389,522 11,511,751
General and
administrative........... 1,031,599 1,310,144 1,633,917 6,182,230 1,170,790 1,065,757 7,247,987
----------- ----------- ----------- ----------- ----------- ----------- -----------
Total operating expenses..... 2,542,077 2,534,985 4,345,925 15,304,459 3,036,463 3,455,279 18,759,738
----------- ----------- ----------- ----------- ----------- ----------- -----------
Operating loss............... (2,542,077) (1,534,985) (3,698,265) (13,526,426) (3,021,463) (2,812,125) (16,338,551)
Interest expense............. (4,755) (752,391) -- (863,740) -- -- (863,740)
Interest income and other,
net........................ 3,333 135,499 330,169 866,614 271,017 353,437 1,220,051
----------- ----------- ----------- ----------- ----------- ----------- -----------
Net loss..................... (2,543,499) (2,151,877) (3,368,096) (13,523,552) (2,750,446) (2,458,688) (15,982,240)
Non-cash preferred
dividends.................. -- -- 1,413,765 1,413,765 1,368,538 34,740 1,448,505
----------- ----------- ----------- ----------- ----------- ----------- -----------
Net loss applicable to common
shareholders............... $(2,543,499) $(2,151,877) $(4,781,861) $(14,937,317) $(4,118,984) $(2,493,428) $(17,430,745)
=========== =========== =========== =========== =========== =========== ===========
Pro forma net loss per share
applicable to common
shareholders............... $ (0.76) $ (0.67) $ (1.11) $ (1.02) $ (0.41)
=========== =========== =========== =========== ===========
Shares used in calculation of
pro forma net loss per
share...................... 3,344,328 3,205,696 4,306,550 4,050,303 6,076,482
=========== =========== =========== =========== ===========
</TABLE>
See accompanying notes
F-4
<PAGE> 61
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT)
<TABLE>
<CAPTION>
SERIES A SERIES B SERIES C
CONVERTIBLE CONVERTIBLE CONVERTIBLE COMMON
PREFERRED STOCK PREFERRED STOCK PREFERRED STOCK STOCK
----------------- ------------------ --------------------- --------
SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES
------- ------- ------- -------- -------- ---------- --------
<S> <C> <C> <C> <C> <C> <C> <C>
Issuance of common stock for cash through
December 31, 1993............................. -- $ -- -- $ -- -- $ -- 834,893
Issuance of common stock for services rendered
through December 31, 1993..................... -- -- -- -- -- -- 269,116
Issuance of common stock in connection with
merger with Pacific Pharmaceuticals, Inc. in
April 1992.................................... -- -- -- -- -- -- 97,062
Issuance of Series B convertible preferred stock
in exchange for convertible promissory notes
in 1992....................................... -- -- 12,750 114,000 -- -- --
Issuance of Series C convertible preferred stock
for cash, net of issuance costs, through
December 31, 1993............................. -- -- -- -- 477,081 4,978,505 --
Repurchase of common shares in 1992............. -- -- -- -- -- -- (3,586)
Issuance of Series A convertible preferred stock
for cash through December 31, 1993............ 26,899 48,500 -- -- -- -- --
Issuance of Series A convertible preferred stock
and warrants to purchase 14,191 shares of
Series A convertible preferred stock in
exchange for convertible promissory notes and
accrued interest through December 31, 1993.... 625,845 1,199,536 -- -- -- -- --
Issuance of Series A convertible preferred stock
for services rendered through December 31,
1993.......................................... 40,597 73,198 -- -- -- -- --
Issuance of Series A convertible preferred stock
in exchange for license agreement through
December 31, 1993............................. 9,513 100,000 -- -- -- -- --
Net loss for the period from June 26, 1989
(inception) through December 31, 1993......... -- -- -- -- -- -- --
------ ------- ------ -------- ------- ---------- -------
Balance at December 31, 1993.................... 702,854 1,421,234 12,750 114,000 477,081 4,978,505 1,197,485
Exercise of options to purchase common stock.... -- -- -- -- -- -- 964
Net loss in 1994................................ -- -- -- -- -- -- --
------ ------- ------ -------- ------- ---------- -------
Balance at December 31, 1994.................... 702,854 1,421,234 12,750 114,000 477,081 4,978,505 1,198,449
<CAPTION>
DEFICIT
ACCUMULATED TOTAL
UNREALIZED DURING THE SHAREHOLDERS'
------- GAIN ON DEVELOPMENT EQUITY
AMOUNT INVESTMENTS STAGE (DEFICIT)
------- ----------- ----------- -------------
<S> <<C> <C> <C> <C>
Issuance of common stock for cash through
December 31, 1993............................. $81,725 $ -- $ -- $ 81,725
Issuance of common stock for services rendered
through December 31, 1993..................... 24,261 -- -- 24,261
Issuance of common stock in connection with
merger with Pacific Pharmaceuticals, Inc. in
April 1992.................................... 8,750 -- -- 8,750
Issuance of Series B convertible preferred stock
in exchange for convertible promissory notes
in 1992....................................... -- -- -- 114,000
Issuance of Series C convertible preferred stock
for cash, net of issuance costs, through
December 31, 1993............................. -- -- -- 4,978,505
Repurchase of common shares in 1992............. (324) -- -- (324)
Issuance of Series A convertible preferred stock
for cash through December 31, 1993............ -- -- -- 48,500
Issuance of Series A convertible preferred stock
and warrants to purchase 14,191 shares of
Series A convertible preferred stock in
exchange for convertible promissory notes and
accrued interest through December 31, 1993.... -- -- -- 1,199,536
Issuance of Series A convertible preferred stock
for services rendered through December 31,
1993.......................................... -- -- -- 73,198
Issuance of Series A convertible preferred stock
in exchange for license agreement through
December 31, 1993............................. -- -- -- 100,000
Net loss for the period from June 26, 1989
(inception) through December 31, 1993......... -- -- (5,460,080) (5,460,080)
------- ------- ------- ----------
Balance at December 31, 1993.................... 114,412 -- (5,460,080) 1,168,071
Exercise of options to purchase common stock.... 1,739 -- -- 1,739
Net loss in 1994................................ -- -- (2,543,499) (2,543,499)
------- ------- ------- ----------
Balance at December 31, 1994.................... 116,151 -- (8,003,579) (1,373,689)
</TABLE>
See accompanying notes.
F-5
<PAGE> 62
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT) (CONTINUED)
<TABLE>
<CAPTION>
SERIES B
SERIES A CONVERTIBLE CONVERTIBLE SERIES C CONVERTIBLE COMMON
PREFERRED STOCK PREFERRED STOCK PREFERRED STOCK STOCK
----------------------- ----------------- --------------------- ----------
SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES
--------- ----------- ------- -------- --------- ---------- ----------
<S> <C> <C> <C> <C> <C> <C> <C>
Exercise of options to purchase common
stock...................................... -- -- -- -- -- -- 20,481
Issuance of warrants in connection with notes
payable financing.......................... -- -- -- -- -- -- --
Conversion of preferred stock to common stock
in connection with IPO..................... (702,854) (1,421,234) (12,750) (114,000) (477,081) (4,978,505) 1,192,685
Issuance of common stock in connection with
IPO........................................ -- -- -- -- -- -- 1,322,500
Issuance of common stock in exchange for
notes payable.............................. -- -- -- -- -- -- 42,960
Net loss in 1995............................. -- -- -- -- -- -- --
-------- ---------- ------- -------- --------- ---------- ---------
Balance at December 31, 1995................. -- -- -- -- -- -- 3,777,075
Issuance of Series A convertible preferred
stock, net of issuance costs............... 750 6,753,230 -- -- -- -- --
Conversion of preferred stock, including
dividends, to common stock................. (555) (6,005,724) -- -- -- -- 1,234,077
Exercise of warrants to purchase common
stock...................................... -- -- -- -- -- -- 135,256
Exercise of options to purchase common
stock...................................... -- -- -- -- -- -- 6,344
Compensation expense related to the extension
of
option exercise periods.................... -- -- -- -- -- -- --
Unrealized gain on investments............... -- -- -- -- -- -- --
Non-cash preferred dividends................. -- 1,413,765 -- -- -- -- --
Net loss in 1996............................. -- -- -- -- -- -- --
-------- ---------- ------- -------- --------- ---------- ---------
Balance at December 31, 1996................. 195 2,161,271 -- -- -- -- 5,152,752
Exercise of warrants to purchase common stock
(unaudited)................................ -- -- -- -- -- -- 205,474
Non-cash preferred dividends (unaudited)..... -- 34,740 -- -- -- -- --
Conversion of preferred stock, including
dividends, to common stock (unaudited)..... (195) (2,196,011) -- -- -- -- 587,879
Exercise of options to purchase common stock
(unaudited)................................ -- -- -- -- -- -- 101,027
Compensation expense related to the extension
of option exercise periods (unaudited)..... -- -- -- -- -- -- --
Issuance of common stock, net of issuance
costs (unaudited).......................... -- -- -- -- -- -- 1,547,827
Unrealized gain on investments (unaudited)... -- -- -- -- -- -- --
Net loss for the nine months ended September
30, 1997 (unaudited)....................... -- -- -- -- -- -- --
-------- ---------- ------- -------- --------- ---------- ---------
Balance at September 30, 1997 (unaudited).... -- $ -- -- $ -- -- $ -- 7,594,959
======== ========== ======= ======== ========= ========== =========
<CAPTION>
DEFICIT
ACCUMULATED TOTAL
UNREALIZED DURING THE SHAREHOLDERS'
----------- GAIN ON DEVELOPMENT EQUITY
AMOUNT INVESTMENTS STAGE (DEFICIT)
----------- ----------- ------------ -------------
<S> <C> <C> <C> <C>
Exercise of options to purchase common
stock...................................... 34,285 -- -- 34,285
Issuance of warrants in connection with notes
payable financing.......................... 487,333 -- -- 487,333
Conversion of preferred stock to common stock
in connection with IPO..................... 6,513,739 -- -- --
Issuance of common stock in connection with
IPO........................................ 6,383,785 -- -- 6,383,785
Issuance of common stock in exchange for
notes payable.............................. 268,500 -- -- 268,500
Net loss in 1995............................. -- -- (2,151,877) (2,151,877)
---------- ------- ----------- -----------
Balance at December 31, 1995................. 13,803,793 -- (10,155,456) 3,648,337
Issuance of Series A convertible preferred
stock, net of issuance costs............... -- -- -- 6,753,230
Conversion of preferred stock, including
dividends, to common stock................. 6,005,724 -- -- --
Exercise of warrants to purchase common
stock...................................... 51,814 -- -- 51,814
Exercise of options to purchase common
stock...................................... 11,553 -- -- 11,553
Compensation expense related to the extension
of
option exercise periods.................... 268,486 -- -- 268,486
Unrealized gain on investments............... -- 22,167 -- 22,167
Non-cash preferred dividends................. -- -- (1,413,765) --
Net loss in 1996............................. -- -- (3,368,096) (3,368,096)
---------- ------- ----------- -----------
Balance at December 31, 1996................. 20,141,370 22,167 (14,937,317) 7,387,491
Exercise of warrants to purchase common stock
(unaudited)................................ 930 -- -- 930
Non-cash preferred dividends (unaudited)..... -- -- (34,740) --
Conversion of preferred stock, including
dividends, to common stock (unaudited)..... 2,196,011 -- -- --
Exercise of options to purchase common stock
(unaudited)................................ 268,807 -- -- 268,807
Compensation expense related to the extension
of option exercise periods (unaudited)..... 69,995 -- -- 69,995
Issuance of common stock, net of issuance
costs (unaudited).......................... 3,818,739 -- -- 3,818,739
Unrealized gain on investments (unaudited)... -- 26,231 -- 26,321
Net loss for the nine months ended September
30, 1997 (unaudited)....................... -- -- (2,458,688) (2,458,688)
---------- ------- ----------- -----------
Balance at September 30, 1997 (unaudited).... $26,495,852 $ 48,398 $(17,430,745) 9,113,505
========== ======= =========== ===========
</TABLE>
See accompanying notes
F-6
<PAGE> 63
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
STATEMENTS OF CASH FLOWS
<TABLE>
<CAPTION>
PERIOD FROM
PERIOD FROM JUNE 26,
JUNE 26, 1989
1989 (INCEPTION)
(INCEPTION) NINE MONTHS ENDED THROUGH
YEARS ENDED DECEMBER 31, THROUGH SEPTEMBER 30, SEPTEMBER
--------------------------------------- DECEMBER 31, ------------------------- 30,
1994 1995 1996 1996 1996 1997 1997
----------- ----------- ----------- ------------ ----------- ----------- ------------
(UNAUDITED) (UNAUDITED)
<S> <C> <C> <C> <C> <C> <C> <C>
OPERATING ACTIVITIES
Net loss...................... $(2,543,499) $(2,151,877) $(3,368,096) $(13,523,552) $(2,750,446) $(2,458,688) $(15,982,240)
Adjustments to reconcile net
loss to net cash used in
operating activities:
Depreciation and
amortization.............. 28,418 27,726 35,384 246,638 28,560 15,256 261,894
Compensation expense related
to the extension of option
exercise periods.......... -- -- 268,486 268,486 34,062 69,995 338,481
Loss on sale of property and
equipment................. -- 3,724 -- 3,724 -- -- 3,724
Amortization of discount on
notes payable and deferred
financing costs........... 4,755 562,748 -- 567,503 -- -- 567,503
Issuance of common shares
for services.............. -- -- -- 24,261 -- -- 24,261
Issuance of Series A
convertible preferred
stock for services
rendered.................. -- -- -- 73,198 -- -- 73,198
Issuance of Series A
convertible preferred
stock for interest........ -- -- -- 67,720 -- -- 67,720
Issuance of Series A
convertible preferred
stock for license
agreement................. -- -- -- 100,000 -- -- 100,000
Changes in operating assets
and liabilities:
Affiliate receivable........ 29,264 -- -- -- -- -- --
Other current assets........ 45,401 (138,811) (201,521) (350,561) (169,383) (97,569) (448,130)
Accounts payable and accrued
liabilities............... 245,136 (149,813) 77,781 270,013 (61,427) (88,035) 181,978
Accrued research fees....... -- -- 21,000 21,000 -- -- 21,000
Accrued compensation and
related expenses.......... 36,039 136,554 (169,308) 17,958 (157,574) 6,455 24,413
Deferred revenue............ 1,000,000 (1,000,000) -- -- -- 500,000 500,000
----------- ----------- ----------- ------------ ----------- ----------- ------------
Net cash used in operating
activities.................. (1,154,486) (2,709,749) (3,336,274) (12,213,612) (3,076,208) (2,052,586) (14,266,198)
INVESTING ACTIVITIES
Purchase of property and
equipment................... -- (22,794) (8,000) (172,893) (8,000) -- (172,893)
Purchases of investments...... -- (1,500,000) (9,576,000) (16,622,520) (5,625,505) (6,990,000) (23,612,520)
Sales and maturities of
investments................. 1,049,861 21,681 3,820,000 9,366,520 220,000 6,256,001 15,622,521
----------- ----------- ----------- ------------ ----------- ----------- ------------
Net cash provided by (used in)
investing activities........ 1,049,861 (1,501,113) (5,764,000) (7,428,893) (5,413,505) (733,999) (8,162,892)
</TABLE>
See accompanying notes.
F-7
<PAGE> 64
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
STATEMENTS OF CASH FLOWS (CONTINUED)
<TABLE>
<CAPTION>
PERIOD FROM
PERIOD FROM JUNE 26,
JUNE 26, 1989
1989 (INCEPTION)
(INCEPTION) NINE MONTHS ENDED THROUGH
YEARS ENDED DECEMBER 31, THROUGH SEPTEMBER 30, SEPTEMBER
--------------------------------------- DECEMBER 31, ------------------------- 30,
1994 1995 1996 1996 1996 1997 1997
----------- ----------- ----------- ------------ ----------- ----------- ------------
(UNAUDITED) (UNAUDITED)
<S> <C> <C> <C> <C> <C> <C> <C>
FINANCING ACTIVITIES
Proceeds from notes payable... $ 536,000 $ 1,749,800 $ -- $ 3,547,424 $ -- $ -- $ 3,547,424
Repayment of notes payable.... -- (2,017,300) -- (2,110,608) -- -- (2,110,608)
Net proceeds from issuance of
common stock................ 1,739 6,418,070 63,367 6,564,901 15,746 4,088,476 10,653,377
Repurchase of common stock.... -- -- -- (324) -- -- (324)
Issuance of convertible
preferred stock, net of
issuance costs.............. -- -- 6,753,230 11,757,735 6,753,230 -- 11,757,735
Deferred financing costs...... (80,170) -- -- (80,170) -- -- (80,170)
----------- ----------- ----------- ------------ ----------- ----------- ------------
Net cash provided by financing
activities.................. 457,569 6,150,570 6,816,597 19,678,958 6,768,976 4,088,476 23,767,434
----------- ----------- ----------- ------------ ----------- ----------- ------------
Net increase (decrease) in
cash........................ 352,944 1,939,708 (2,283,677) 36,453 (1,720,737) 1,301,891 1,338,344
Cash at beginning of period... 27,478 380,422 2,320,130 -- 2,320,130 36,453 --
----------- ----------- ----------- ------------ ----------- ----------- ------------
Cash at end of period......... $ 380,422 $ 2,320,130 $ 36,453 $ 36,453 $ 599,393 $ 1,338,344 $ 1,338,344
============ ============ ============ ============= ============ ============ =============
SUPPLEMENTAL DISCLOSURE OF
NON-CASH TRANSACTIONS
Conversion of preferred stock
and dividends to common
stock....................... $ -- $ 6,513,739 $ 6,005,724 $ 12,519,463 $ 5,498,000 $ 2,196,011 $ 14,715,474
============ ============ ============ ============= ============ ============ =============
Issuance of common stock for
notes payable............... $ -- $ 268,500 $ -- $ 268,500 $ -- $ -- $ 268,500
============ ============ ============ ============= ============ ============ =============
Issuance of warrants in
connection with notes
payable financing........... $ -- $ 487,333 $ -- $ 487,333 $ -- $ -- $ 487,333
============ ============ ============ ============= ============ ============ =============
Issuance of Series A
convertible preferred stock
for notes payable $ -- $ -- $ -- $ 1,153,316 $ -- $ -- $ 1,153,316
============ ============ ============ ============= ============ ============ =============
Issuance of Series B
convertible preferred stock
for notes payable........... $ -- $ -- $ -- $ 115,000 $ -- $ -- $ 115,000
============ ============ ============ ============= ============ ============ =============
Issuance of common stock for
Pacific Pharmaceuticals,
Inc......................... $ -- $ -- $ -- $ 8,750 $ -- $ -- $ 8,750
============ ============ ============ ============= ============ ============ =============
</TABLE>
See accompanying notes.
F-8
<PAGE> 65
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS
(INFORMATION AT SEPTEMBER 30, 1997
AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1997 IS UNAUDITED)
1. ACCOUNTING POLICIES
Description of Business
The Company is engaged in the development of prescription drugs and
cosmeceutical products based upon its patented transdermal and topical drug
delivery technologies and its expertise in skin biology. The Company is in the
development stage.
Basis of Presentation
In the course of its development, the Company has incurred significant
losses and will continue to incur additional losses during its development
phase. As a result, the Company will require substantial additional funds for
its operational activities and may seek private or public equity financings and
future collaborative arrangements with third parties to meet its cash needs.
There is no assurance that such additional funds will be available on acceptable
terms or available at all. Insufficient funding may require the Company to
delay, reduce, or eliminate some or all of its research and development, planned
clinical trials, and administrative programs.
Interim Financial Statements
In the opinion of management, the unaudited financial statements include
all adjustments (consisting of normal recurring accruals) necessary to present
fairly the Company's results of operations and cash flows for the nine months
ended September 30, 1996 and 1997. Results for the nine months ended September
30, 1997 are not necessarily indicative of the results to be expected for the
year ended December 31, 1997.
Use of Estimates
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those estimates.
Revenues and Research and Development Expenses
Revenues related to cost reimbursement provisions under development
contracts are recognized as the costs associated with the projects are incurred.
Revenues related to milestones specified under development contracts are
recognized as the milestones are achieved. Research and development costs are
expensed as incurred.
The Company receives certain United States government grants that support
the Company's research effort in defined research projects. These grants
generally provide for reimbursement of approved costs incurred as defined in the
various grants. Revenues associated with these grants are recognized as costs
under each grant are incurred.
Cash, Cash Equivalents, and Investments
Cash equivalents consist of highly liquid financial instruments with
original maturities of three months or less.
The Company accounts for its investments in accordance with Statement of
Financial Accounting Standards No. 115, "Accounting for Certain Investments in
Debt and Equity Securities" (FAS 115). Under
F-9
<PAGE> 66
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
(INFORMATION AT SEPTEMBER 30, 1997
AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1997 IS UNAUDITED)
FAS 115, management classifies investments as available-for-sale or
held-to-maturity at the time of purchase and periodically reevaluates such
designations. Investments in marketable equity securities and debt securities
are classified as held-to-maturity when the Company has the positive intent and
ability to hold the securities to maturity. Held-to-maturity securities are
stated at amortized cost with corresponding premiums or discounts amortized to
interest income over the life of the investment. Debt securities, not classified
as held-to-maturity, are classified as available-for-sale and are reported at
fair market value. Unrealized gains or losses on available-for-sale securities
are included in shareholders' equity until their disposition. Realized gains or
losses and declines in value judged to be other than temporary on
available-for-sale securities are included in other income or expense.
While the Company's intent is to hold debt securities to maturity, they are
classified as available-for-sale because the sale of such securities may be
required prior to maturity.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation.
Depreciation is provided over the estimated useful life of five years using the
straight-line method.
Stock-Based Compensation
The Company accounts for its stock option grants in accordance with
Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to
Employees" (APB Opinion No. 25) and has elected to follow the disclosure-only
alternative prescribed by Statement of Financial Accounting Standards No. 123,
"Accounting for Stock-Based Compensation" (FAS 123).
Pro forma Net Loss Per Share Applicable to Common Shareholders
Net loss per share applicable to common shareholders is computed using the
weighted average number of shares of common stock outstanding. Common equivalent
shares are excluded from the computation as their effect is antidilutive, except
that, pursuant to Securities and Exchange Commission Staff Accounting Bulletins,
common and common equivalent shares issued (stock options and warrant grants) at
prices below the public offering price during the twelve-month period prior to
the initial public offering have been included in the calculation as if they
were outstanding for all periods through March 31, 1995 using the treasury stock
method. The net loss per share applicable to common shareholders, computed on
this basis, was $(1.18), $(0.86), and $(1.11) for the years ended December 31,
1994, 1995, and 1996, respectively. Shares used in the net loss per share
calculation were 2,151,643, 2,509,963, and 4,306,550 for the years ended
December 31, 1994, 1995, and 1996, respectively.
The pro forma net loss per share applicable to common shareholders
presented in the statements of operations is computed as described above and
also gives effect for all periods presented to the conversion of all outstanding
shares of convertible preferred stock into common stock that took place upon the
closing of the Company's initial public offering in August 1995.
F-10
<PAGE> 67
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
(INFORMATION AT SEPTEMBER 30, 1997
AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1997 IS UNAUDITED)
2. INVESTMENTS
At December 31, 1996, investments consist of the following:
<TABLE>
<CAPTION>
UNREALIZED UNREALIZED
COST GAINS LOSSES FAIR VALUE
---------- ------- ------- ----------
<S> <C> <C> <C> <C>
Short-term:
Corporate notes............ $2,000,000 $ 8,280 $ -- $2,008,280
U.S. Government notes...... 2,400,000 310 (1,886) 2,398,424
Time Deposits.............. 500,000 -- -- 500,000
Commercial paper........... 356,000 -- (7,036) 348,964
---------- ------- ------- ----------
5,256,000 8,590 (8,922) 5,255,668
Long-term:
U.S. Government notes.... 2,000,000 22,499 -- 2,022,499
---------- ------- ------- ----------
Total...................... $7,256,000 $31,089 $(8,922) $7,278,167
========== ======= ======= ==========
</TABLE>
The cost and estimated fair market value of investments in debt securities
at December 31, 1996, by contractual maturity, were as follows:
<TABLE>
<CAPTION>
FAIR
MARKET
COST VALUE
---------- ----------
<S> <C> <C>
Due in 1 year or less........................... $5,256,000 $5,255,668
Due in 1-3 years................................ 2,000,000 2,022,499
---------- ----------
Total investments............................... $7,256,000 $7,278,167
========== ==========
</TABLE>
At December 31, 1995, short-term investments consisted of a U.S. government
obligation that matured in May 1996. There have been no net realized gains or
losses on the sale of securities for the years ended December 31, 1994, 1995 and
1996.
3. PROPERTY AND EQUIPMENT
Property and equipment consist of the following:
<TABLE>
<CAPTION>
DECEMBER 31,
----------------------
1995 1996
-------- ---------
<S> <C> <C>
Furniture and fixtures................................ $ 41,702 $ 49,702
Office equipment...................................... 39,142 39,142
Laboratory equipment.................................. 65,310 65,310
Leasehold improvements................................ 3,610 3,610
-------- --------
149,764 157,764
(91,099) (126,483)
-------- --------
Less accumulated depreciation......................... $ 58,665 $ 31,281
======== ========
</TABLE>
4. NOTES PAYABLE
In a December 1994 private placement, the Company issued $536,000 principal
amount of 10% convertible subordinated debentures and warrants to acquire
107,200 shares of common stock at an exercise price of $7.81. The value ascribed
to the warrants for financial statement purposes was not material.
F-11
<PAGE> 68
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
(INFORMATION AT SEPTEMBER 30, 1997
AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1997 IS UNAUDITED)
In February 1995 and June 1995 private placements, the Company issued
$1,749,800 principal amount of 10% convertible secured debentures (Notes) and
warrants (Warrants) to acquire units (Units), each Unit consisting of one share
of common stock and one common stock purchase warrant (Unit Warrant). In
connection with the February 1995 transaction, all investors who acquired notes
and warrants in December 1994 exchanged the securities acquired in December 1994
for an equal principal amount of Notes and Warrants on the same terms as the
other investors. The Warrants were valued by an outside valuation firm for
financial statement purposes at approximately $487,000, which amount was
recorded as an addition to common stock with a corresponding discount on the
notes payable. The discount was amortized using the interest method. The Notes
were convertible at the option of the noteholder into Units consisting of one
share of common stock and one warrant (Conversion Warrant) to purchase one share
of common stock. The exercise price of the Warrants is $0.01 per unit. The
exercise price of the Unit Warrants is $7.81 per share.
In August 1995, in connection with the close of its initial public
offering, the Company repaid Notes totaling approximately $2,017,000 and accrued
interest totaling approximately $100,000. Notes totaling $268,500 were converted
into 42,960 shares of common stock and warrants to acquire 42,960 shares of
common stock. The warrants were exercisable beginning in February 1996 at an
exercise price of $5.19 per share and will expire December 31, 1999.
5. LEASE COMMITMENTS
The Company leases its facilities and equipment under non-cancelable
operating leases. Future minimum lease payments at December 31, 1996 are as
follows:
<TABLE>
<S> <C>
1997............................................................. $ 331,803
1998............................................................. 238,480
1999............................................................. 243,285
2000............................................................. 198,826
2001............................................................. 77,051
----------
$1,089,445
==========
</TABLE>
Lease expense was $72,764, $67,959, and $209,715 for the years ended
December 31, 1994, 1995, and 1996, respectively. For the year ended December 31,
1996, such lease expense included $63,836 of equipment lease expense.
6. SHAREHOLDERS' EQUITY
Initial Public Offering
In August 1995, the Company completed an initial public offering of 661,250
units with each unit consisting of two shares of common stock and one common
stock purchase warrant with an exercise price of $9.375 per share. The Company
received net proceeds of approximately $6.4 million. In connection with the
initial public offering, Series A, B, and C preferred stock, then outstanding,
converted into 1,192,685 shares of common stock.
In July 1995, the Company's Board of Directors also approved a
0.746-for-one reverse stock split of issued and outstanding common and preferred
shares and commensurate adjustments of outstanding options and warrants
(including purchase prices and exercise prices). All share amounts in the
accompanying financial statements have been retroactively adjusted to reflect
this reverse stock split.
F-12
<PAGE> 69
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
(INFORMATION AT SEPTEMBER 30, 1997
AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1997 IS UNAUDITED)
Convertible Series A Preferred Stock Offering
On April 19, 1996, the Company completed a $7,500,000 private placement of
750 shares of convertible Series A preferred stock (Series A Preferred) or
(Preferred Stock Financing). Net proceeds were $6,753,230. The shares were
convertible, at the option of the holder, into common stock. The number of
shares of common stock issuable on conversion of a share of Series A Preferred
was calculated based on the lower of $6.6275 or a variable conversion price of
85% of the average market price of the common stock on the five trading days
proceeding the conversion date. At September 30, 1997, all Series A Preferred
have been converted to common stock.
Two years after issuance of Series A Preferred, if there were any remaining
unconverted preferred shares, such shares would have automatically been
converted into common stock. A conversion premium accrued at the rate of 8
percent per annum and was payable upon conversion in shares of common stock. As
of September 30, 1997, 1,821,956 shares of common stock have been issued in
conjunction with the conversion of Series A Preferred. The holders of the Series
A Preferred had no voting rights except as required by applicable California
law.
For the year ended December 31, 1996, the Company accrued noncash preferred
dividends of $1,125,000 reflecting the 15% discount in conjunction with the
common stock variable conversion price of the Series A preferred stock, and
noncash preferred dividends of $288,765 ($34,740 for the nine months ended
September 30, 1997) reflecting the 8% per annum mandatory preferred dividends of
the Series A preferred stock.
In the event of any liquidation, the Series A Preferred shareholders were
entitled to receive a preferential amount equal to $10,000 per share plus the 8%
per annum accrued dividends.
Common Stock Private Placement
On July 23, 1997, the Company completed a $3,850,000 private placement of
1,547,827 shares of common stock. The purchase price for all investors, except
the Company's chief executive officer, was $2.375 per share. The purchase price
for the shares purchased by the Company's chief executive officer in the private
placement was $2.875 per share, which is equal to the closing price of the
common stock on the Nasdaq SmallCap Market on the date immediately preceding the
closing date.
Preferred Stock
The Company's Articles of Incorporation provide that the Company may issue
shares of preferred stock in one or more series. The Board of Directors is
authorized to establish from time to time the numbers of shares to be included
in, and the designation of, any such shares to determine or alter the rights,
preferences, privileges, and restrictions granted to or imposed upon any wholly
unissued series of preferred stock and to increase or decrease the number of
shares of any such series without any further vote or action by the
shareholders.
F-13
<PAGE> 70
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
(INFORMATION AT SEPTEMBER 30, 1997
AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1997 IS UNAUDITED)
Warrants
The Company has the following warrants outstanding to purchase common stock
at September 30, 1997:
<TABLE>
<CAPTION>
NUMBER OF EXERCISE PRICE EXPIRATION
SHARES PER SHARE DATE ISSUED DATE
- ---------- -------------- -------------- ------------------
<S> <C> <C> <C>
35,496 $ 4.51 October 1994.. December 31, 1999
$ 0.01 February 1995. December 31, 1999
$ 7.81 February 1995. December 31, 1999
44,604 $ 9.02 March 1995.... December 31, 1999
42,960 $ 5.19 August 1995... December 31, 1999
115,000 $ 10.31 August 1995... August 11, 2000
57,500 $ 15.47 August 1995... August 11, 2000
661,250 $ 9.375 August 1995... August 11, 2000
86,005 $ 7.23 April 1996.... April 18, 2001
7,000 $ 6.25 April 1996.... April 24, 1998
25,000 $ 4.00 July 1997..... July 22, 1998
- ----------
1,493,311
==========
</TABLE>
Included in the table above are warrants to acquire 661,250 shares of
common stock at a price of $9.375 per share that were issued in connection with
the Company's initial public offering. The warrants are exercisable at any time
unless previously redeemed until August 11, 2000. The Company may redeem the
warrants, in whole or in part, at any time upon at least thirty days prior
written notice to the warrant holders at a price of $0.05 per warrant provided
that the closing price of the common stock has been at least $12.50 for at least
ten consecutive trading days ending on a date within 30 days before the date of
the notice of redemption. No warrants have been redeemed through September 30,
1997.
Stock Option Plans
In 1995, the Company adopted the Equity Incentive Plan (the Plan) to
provide for the issuance of incentive stock options and nonstatutory stock
options. When the Plan was established, the Company reserved 700,000 shares for
issuance. In 1996, an additional 300,000 shares were reserved for issuance under
the Plan. In June 1997, an additional 450,000 shares were reserved for issuance
under the Plan. Under the Plan, incentive stock options may be granted at a
price per share of not less than the fair market value of common stock on the
date of grant. Nonqualified options may be granted at a price per share of not
less than 85% of fair market value on the date of grant. Options are exercisable
to the extent vested. Vesting is established by the Compensation Committee.
F-14
<PAGE> 71
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
(INFORMATION AT SEPTEMBER 30, 1997
AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1997 IS UNAUDITED)
Activity under the Plan is summarized as follows:
<TABLE>
<CAPTION>
SHARES UNDER PRICE RANGE WEIGHTED AVERAGE
OPTION PER SHARE EXERCISE PRICE
------------ ------------- ----------------
<S> <C> <C> <C>
Balance at December 31, 1993........... 131,942 $ 1.81 $ 1.81
Granted.............................. 66,743 $0.45 - $1.81 $ 1.42
Canceled............................. (61,426) $ 1.81 $ 1.81
Exercised............................ (964) $ 1.81 $ 1.81
--------
Balance at December 31, 1994........... 136,295 $0.45 - $4.50 $ 1.64
Granted.............................. 619,382 $2.09 - $6.66 $ 3.48
Canceled............................. (84,511) $1.81 - $4.50 $ 1.92
Exercised............................ (20,481) $0.50 - $1.81 $ 1.67
--------
Balance at December 31, 1995........... 650,685 $0.45 - $6.66 $ 3.35
Granted.............................. 605,447 $4.56 - $8.25 $ 5.43
Canceled............................. (253,443) $1.39 - $6.38 $ 4.49
Exercised............................ (6,344) $1.81 - $2.09 $ 1.82
--------
Balance at December 31, 1996........... 996,345 $0.45 - $8.25 $ 4.34
Granted.............................. 303,500 $3.00 - $6.06 $ 3.96
Canceled............................. (213,371) $3.07 - $8.25 $ 5.58
Exercised............................ (101,027) $0.50 - $4.38 $ 2.66
--------
Balance at September 30, 1997.......... 985,447 $0.45 - $8.25 $ 4.12
========
</TABLE>
At December 31, 1996, options to purchase 441,840 shares of common stock
were vested and exercisable at exercise prices ranging from $0.45 to $8.25 per
share. At December 31, 1996, options to purchase 91,500 shares of common stock
at exercise prices ranging from $4.56 to $7.25 per share vest in the year of
2001 but are subject to earlier vesting if certain performance criteria are met.
At December 31, 1996, no options to purchase shares of common stock were
available for future option grants under the Plan.
As of September 30, 1997, options to purchase 347,481 shares of common
stock were vested and exercisable at exercise prices ranging from $0.45 to $6.66
per share. At September 30, 1997, 335,737 options to purchase shares of common
stock were available for future option grants under the Plan.
The following table summarizes information about stock options outstanding
and exercisable at December 31, 1996:
<TABLE>
<CAPTION>
OPTIONS OUTSTANDING
--------------------------------------- OPTIONS EXERCISABLE
WEIGHTED -------------------------
NUMBER AVERAGE WEIGHTED NUMBER WEIGHTED
OUTSTANDING AT REMAINING AVERAGE EXERCISABLE AT AVERAGE
DECEMBER 31, CONTRACTUAL EXERCISE DECEMBER 31, EXERCISE
RANGE OF EXERCISE PRICE 1996 LIFE PRICE 1996 PRICE
- --------------------------------------- -------------- ----------- -------- -------------- --------
<S> <C> <C> <C> <C> <C>
$0.45 - $3.07.......................... 277,170 5.4 years $ 2.10 183,643 $ 2.00
$4.38 - $5.75.......................... 579,975 8.2 years $ 4.76 218,447 $ 4.68
$6.25 - $8.25.......................... 139,200 8.0 years $ 7.02 39,750 $ 6.78
------- -------
Total.................................. 996,345 7.4 years $ 4.34 441,840 $ 3.76
======= =======
</TABLE>
F-15
<PAGE> 72
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
(INFORMATION AT SEPTEMBER 30, 1997
AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1997 IS UNAUDITED)
In February 1995, the Company adopted the Directors' Stock Option Plan. The
Company reserved 100,000 shares of common stock for issuance under the Plan. In
June 1997, an additional 50,000 shares were reserved for issuance under the
Plan. The Plan provides for the automatic annual grant of an option to acquire
1,000 shares of common stock to each nonemployee then serving as a director at
an exercise price equal to the fair value of the common stock on the date of
grant. The Plan also provides for an initial option grant (Initial Option) to
acquire 20,000 shares of common stock to each current and future nonemployee
director of the Company at an exercise price equal to the fair value of the
common stock on the date of grant. Vesting generally occurs over four years from
the date of grant except that 25% of the shares subject to the Initial Option
generally become exercisable on the grant date. Pursuant to the Plan, one option
to purchase 20,000 shares of common stock at an exercise price of $5.00 per
share was granted during the year ended December 31, 1995. During the year ended
December 31, 1996, options were granted to purchase a total of 50,000 shares of
common stock at exercise prices ranging from $4.50 to $8.50. Options to purchase
18,750 shares of common stock at exercise prices ranging from $4.50 to $5.50
were vested and exercisable at December 31, 1996. At December 31, 1996, options
to purchase 30,000 shares of common stock were available for future option
grants under the Plan. For the nine months ended September 30, 1997, the Company
granted 6,000 options under the Plan at an exercise price of $3.25.
The following table summarizes information about stock options outstanding
and exercisable related to the Directors' Stock Option Plan at December 31,
1996:
<TABLE>
<CAPTION>
OPTIONS OUTSTANDING OPTIONS EXERCISABLE
------------------------------------------ --------------------------
NUMBER WEIGHTED NUMBER
OUTSTANDING AVERAGE WEIGHTED EXERCISABLE WEIGHTED
AT REMAINING AVERAGE AT AVERAGE
RANGE OF DECEMBER 31, CONTRACTUAL EXERCISE DECEMBER 31, EXERCISE
EXERCISE PRICE 1996 LIFE PRICE 1996 PRICE
- --------------------------------- ------------ ------------ -------- ------------ ---------
<S> <C> <C> <C> <C> <C>
$4.50 - $5.50.................... 65,000 9.5 years $ 4.97 18,750 $5.00
$8.50............................ 5,000 9.4 years $ 8.50 -- $ --
------ ------
Total............................ 70,000 9.5 years $ 5.22 18,750 $5.00
====== ======
</TABLE>
The Company has elected to follow APB Opinion No. 25 and related
interpretations in accounting for its stock options since, as discussed below,
the alternative fair market value accounting provided for under FAS 123 requires
use of option valuation models that were not developed for use in valuing stock
options. Under APB Opinion No. 25, if the exercise price of the Company's stock
options is equal to the market price of the underlying stock on the date of
grant, no compensation expense is recognized.
F-16
<PAGE> 73
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
(INFORMATION AT SEPTEMBER 30, 1997
AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1997 IS UNAUDITED)
Pro forma information regarding net loss and net loss per share is required
by FAS 123, which also requires that the information be determined as if the
Company has accounted for its stock options granted subsequent to December 31,
1994 under the fair market value method. The fair market value for options
granted in 1995 prior to the IPO was estimated at the date of the grant using
the Minimum Value Method. The fair market value for options granted in 1995
after the IPO, as well as in 1996, was estimated at the date of the grant using
a Black-Scholes option pricing model. The Company valued its options using the
following weighted average assumptions for the years ended December 31, 1995 and
1996:
<TABLE>
<CAPTION>
YEARS ENDED
DECEMBER 31,
------------------
1995 1996
------ ------
<S> <C> <C>
Risk-free interest rate................................... 6.37% 6.23%
Dividend yield............................................ 0% 0%
Volatility................................................ 0.235 0.517
Expected life of options in years......................... 4.0 4.8
</TABLE>
The Black-Scholes option valuation model was developed for use in
estimating the fair market value of traded options that have no vesting
restrictions and are fully transferable. In addition, option valuation models
require the input of highly subjective assumptions, including the expected stock
price volatility. Because the Company's stock options have characteristics
significantly different from those of traded options, and because changes in the
subjective input assumptions can materially affect the fair market value
estimate, in management's opinion, the existing models do not necessarily
provide a reliable single measure of the fair market value of its stock options.
For purposes of pro forma disclosures, the estimated fair value of the
options is amortized to expense over the options' vesting period. The Company's
pro forma information follows:
<TABLE>
<CAPTION>
1995 1996
----------- -----------
<S> <C> <C>
Pro forma net loss applicable to common
shareholders.................................... $(5,494,675) $(2,235,129)
Pro forma net loss per share applicable to common
shareholders.................................... $ (1.29) $ (0.70)
</TABLE>
The weighted average grant date fair value of options granted during the
years ended December 31, 1995 and 1996 was $1.17 and $2.79, respectively.
As a result of FAS 123 only being applicable to options granted subsequent
to December 31, 1994, its pro forma effect will not be fully reflected until the
year ending December 31, 1999.
7. LICENSE AGREEMENTS
In November 1996, the Company entered into an agreement with Glaxo Wellcome
Inc. (Glaxo) for licensing rights to Glylorin, Cellegy's lipid compound for the
treatment of ichthyoses. Under the terms of the agreement, Cellegy provided
Glaxo with an exclusive license of patent rights and know-how covering Glylorin
in most of the world's major markets. In exchange for this license, the Company
received from Glaxo an initial license fee payment and could potentially receive
future milestone payments (upon achievement of the specified milestones)
totaling, including the initial payment, over $8.0 million, as well as a royalty
on net sales assuming successful completion of product development and market
launch. There can be no assurances, however, that the Company will receive any
additional payments from Glaxo. The agreement provides that
F-17
<PAGE> 74
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
(INFORMATION AT SEPTEMBER 30, 1997
AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1997 IS UNAUDITED)
Glaxo will assume responsibility for and the associated costs of all future
development and commercialization, including certain development costs incurred
prior to the date of the agreement.
In October 1993, the Company entered into a license agreement with the
University of California (the "Licensor") providing for an exclusive, worldwide,
royalty-bearing license, subject to customary government rights, for patent
rights relating to barrier repair formulations, jointly held by the Licensor and
the Company, in consideration of the issuance to the Licensor of certain shares
of preferred stock (which subsequently converted into shares of common stock)
and the payment by the Company of a licensing fee. In March 1994, the Company
entered into a second exclusive, worldwide, royalty-bearing license agreement
with the Licensor for patent rights jointly held by the Licensor and the
Company, relating to drug delivery technologies, in consideration of the payment
by the Company of a licensing fee, and an annual maintenance fee payable each
year until the Company is commercially selling a licensed product. Both
agreements require the Company to pay the Licensor royalties based on net sales
of consumer and prescription products (with minimum annual royalty payments).
The Company has the right to grant sublicenses to third parties under both
agreements. In May and October 1997, the Licensor and the Company amended these
agreements. The amendments modified and extended certain development and
commercialization milestones contained in the original agreements. The revised
milestones are tied to the achievement of certain clinical, regulatory, or
product commercialization goals over the next several years. Although there can
be no assurance that such goals will be achieved, the Company believes its
development programs in place will result in the satisfaction of such
milestones.
In April 1992, the Company entered into the License Option Agreement (the
"License Option Agreement"), the Azelaic Acid OTC License Agreement (the
"Azelaic Acid Agreement") and the Metabolic Moisturizer OTC License Agreement
(the "Metabolic Moisturizer Agreement"), with Neutrogena Corporation. The
Azelaic Acid Agreement was terminated and replaced by the Patent License
Agreement effective June 1, 1994 (the "Patent License Agreement"). Pursuant to
the Patent License Agreement, Neutrogena paid the Company $1.0 million for an
exclusive, royalty-free license for certain azelaic acid uses for both
prescription and consumer products in most major markets of the world. In July
1997, Neutrogena and the Company terminated the Metabolic Moisturizer Agreement
and the License Option Agreement (except as it relates to azelaic acid), and the
metabolic moisturizer technology that had been licensed to Neutrogena was
returned to the Company. The Company agreed to continue prosecution of patents
related to azelaic acid on behalf of Neutrogena and will be reimbursed by
Neutrogena for legal costs, up to a certain limit.
8. RELATED PARTY TRANSACTIONS
The Company has entered into consulting agreements with certain
shareholders of the Company. The total consulting fees paid to these
shareholders was $201,000, $129,000, and $52,250 for the years ended December
31, 1994, 1995, and 1996, respectively. One of these consulting agreements
requires a shareholder to provide consulting services through May 1999 in
exchange for monthly payments of approximately $3,500.
9. INCOME TAXES
At December 31, 1996, the Company has net operating loss carryforwards of
approximately $12,805,000 and $4,666,000 for federal and state purposes,
respectively. The federal net operating loss carryforwards expire between the
years 2004 and 2011. The state net operating loss carryforwards expire between
the years 1997 and 2001. At December 31, 1996, the Company also has research and
development credit carryforwards of
F-18
<PAGE> 75
CELLEGY PHARMACEUTICALS, INC.
(A DEVELOPMENT-STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS (CONTINUED)
(INFORMATION AT SEPTEMBER 30, 1997
AND FOR THE NINE MONTHS ENDED SEPTEMBER 30, 1996 AND 1997 IS UNAUDITED)
approximately $262,000 and $95,000 for federal and state purposes, respectively.
The federal credits expire between the years 2006 and 2011. The state credits
have no expiration date.
Pursuant to the "change in ownership" provisions of the Tax Reform Act of
1986, utilization of the Company's net operating loss and research and
development tax credit carryforwards may be limited if a cumulative change of
ownership of more than 50% occurs within any three-year period.
Deferred income taxes reflect the net tax effects of temporary differences
between the carrying amounts of assets and liabilities for financial reporting
purposes and the amounts used for income tax purposes. Significant components of
the Company's deferred tax liabilities and assets are as follows:
<TABLE>
<CAPTION>
DECEMBER 31,
---------------------------
1995 1996
----------- -----------
<S> <C> <C>
Deferred tax assets:
Net operating loss carryforwards........................ $ 3,500,000 $ 4,634,000
Credit carryforwards.................................... 258,000 357,000
Capitalized research and development costs.............. 139,000 251,000
Capital loss carryforwards.............................. 39,000 39,000
Capitalized license fee................................. 50,000 50,000
Other................................................... 33,000 17,000
----------- -----------
Total deferred tax assets................................. 4,019,000 5,348,000
Valuation allowance....................................... (3,980,000) (5,315,000)
----------- -----------
Net deferred tax assets................................... 39,000 33,000
Deferred tax liabilities.................................. (39,000) (33,000)
----------- -----------
Net deferred tax assets................................... $ -- $ --
=========== ===========
</TABLE>
F-19
<PAGE> 76
======================================================
NO DEALER, SALESPERSON OR ANY OTHER PERSON HAS BEEN AUTHORIZED TO GIVE ANY
INFORMATION OR TO MAKE ANY REPRESENTATIONS IN CONNECTION WITH THIS OFFERING
OTHER THAN THOSE CONTAINED IN THIS PROSPECTUS, AND, IF GIVEN OR MADE, SUCH
INFORMATION OR REPRESENTATIONS MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED
BY THE COMPANY OR THE UNDERWRITER. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER
TO SELL OR A SOLICITATION OF AN OFFER TO BUY ANY OF THE SECURITIES OFFERED
HEREBY IN ANY JURISDICTION TO ANY PERSON TO WHOM IT IS UNLAWFUL TO MAKE SUCH
OFFER OR SOLICITATION IN SUCH JURISDICTION. NEITHER THE DELIVERY OF THIS
PROSPECTUS NOR ANY SALE MADE HEREUNDER SHALL, UNDER ANY CIRCUMSTANCES, CREATE
ANY IMPLICATION THAT THERE HAS BEEN NO CHANGE IN THE AFFAIRS OF THE COMPANY
SINCE THE DATE AS OF WHICH INFORMATION IS FURNISHED.
---------------------
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
Prospectus Summary.................... 3
Risk Factors.......................... 6
Use of Proceeds....................... 13
Price Range of Common Stock........... 13
Capitalization........................ 14
Dividend Policy....................... 14
Dilution.............................. 15
Selected Financial Data............... 16
Management's Discussion and Analysis
of Financial Condition and Results
of Operations....................... 17
Business.............................. 21
Management............................ 39
Certain Transactions.................. 46
Principal Stockholders................ 47
Description of Capital Stock.......... 50
Shares Eligible for Future Sale....... 52
Underwriting.......................... 54
Legal Matters......................... 55
Experts............................... 55
Available Information................. 55
Index to Consolidated Financial
Statements.......................... F-1
</TABLE>
======================================================
======================================================
2,250,000 SHARES
LOGO
COMMON STOCK
------------------------
PROSPECTUS
------------------------
(LOGO)
, 1997
======================================================
<PAGE> 77
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
The following table sets forth the costs and expenses to be paid in
connection with the sale of the shares of Common Stock being registered hereby,
all of which will be paid by the Company. All amounts are estimates except for
the Securities and Exchange Commission registration fee.
<TABLE>
<S> <C>
Securities and Exchange Commission registration fee............ $ 6,763
NASD fee....................................................... 2,700
Nasdaq National Market listing fee............................. 15,000
Blue sky fees and expenses..................................... --
Accounting fees and expenses................................... 60,000
Legal fees and expenses........................................ 200,000
Transfer Agent and Registrar Fees.............................. 6,537
Printing and miscellaneous..................................... 175,000
--------
Total................................................ $466,000
========
</TABLE>
ITEM 14. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
The Registrant's Amended and Restated Articles of Incorporation (the
"Restated Articles") include a provision that eliminates the personal liability
of its directors to the Registrant and its shareholders for monetary damages for
breach of the directors' fiduciary duties to the maximum extent permitted under
California law. This limitation has no effect on a director's liability (i) for
acts or omissions that involve intentional misconduct or a knowing and culpable
violation of law, (ii) for acts or omissions that a director believes to be
contrary to the best interests of the Registrant or its shareholders or that
involve the absence of good faith on the part of the director, (iii) for any
transaction from which a director derived an improper personal benefit, (iv) for
acts or omissions that show a reckless disregard for the director's duty to the
Registrant or its shareholders in circumstances in which the director was aware,
or should have been aware, in the ordinary course of performing a director's
duties, of a risk of a serious injury to the Registrant or its shareholders, (v)
for acts or omissions that constitute an unexcused pattern of inattention that
amounts to an abdication of the director's duty to the Registrant or its
shareholders, (vi) under Section 310 of the California Corporations Code (the
"California Code") (concerning contracts or transactions between the Registrant
and a director) or (vii) under Section 316 of the California Code (concerning
directors' liability for improper dividends, loans and guarantees). The
provision does not extend to acts or omissions of a director in his capacity as
an officer. Further, the provision has no effect on claims arising under federal
or state securities laws and will not affect the availability of injunctions and
other equitable remedies available to the Registrant's shareholders for any
violation of a director's fiduciary duty to the Registrant or its shareholders.
The Restated Articles also include an authorization for the Registrant to
indemnify its agents (as defined in Section 317 of the California Code), through
bylaws provisions, by agreement or otherwise, to the fullest extent permitted by
law. Pursuant to this latter provision, the Registrant's Bylaws provide for
indemnification of the Registrant's directors, officers and employees.
Indemnification may only be authorized by a majority of Registrant's directors
or shareholders or by order of a court, unless the agent has been successful on
the merits. In addition, the Registrant's policy is to enter into
indemnification agreements with each of its officers and directors. These
indemnification agreements provide that directors and officers will be
indemnified and held harmless to the fullest extent permitted by law. These
agreements, together with the Restated Articles, may require the Registrant,
among other things, to indemnify such directors, officers and employees against
certain liabilities that may arise by reason of their status or service as
directors or officers (other than liabilities resulting from willful misconduct
of a culpable nature), to advance expenses to them as they are incurred,
provided that they undertake to repay the amount advanced if it is ultimately
determined by a court that they
II-1
<PAGE> 78
are not entitled to indemnification, and to obtain directors' and officers'
insurance if available on reasonable terms.
Section 317 of the California Code makes provisions for the indemnification
of officers, directors and other corporate agents in terms sufficiently broad to
indemnify such persons, under certain circumstances, for liabilities (including
reimbursement of expenses incurred) arising under the Securities Act.
The Underwriting Agreement referred to below sets forth certain provisions
with respect to the indemnification of the Registrant and certain directors,
officers, and controlling persons against certain losses and liabilities,
including certain liabilities under the Securities Act.
The Amended and Restated Registration Rights Agreement dated April 10,
1992, entered into by and among the Registrant and various investors, and the
Amended and Restated Registration Rights Agreement dated February 10, 1995,
entered into by and among the Registrant and various investors provide for cross
indemnification of certain holders of Registrant's securities, and of Registrant
and its officers and directors for certain liabilities existing under the
Securities Act and otherwise.
The Registrant also maintains a director and officer liability policy.
ITEM 15. RECENT SALES OF UNREGISTERED SECURITIES.
1. Bridge Financing. On December 7, 1994, the Company issued $536,000
principal amount of Bridge Notes and Bridge Warrants to acquire 76,571 shares of
Common Stock in a private placement transaction 21. Net proceeds were
approximately $455,000. The foregoing securities were issued in reliance upon
Section 4(2) of the Securities Act, based primarily upon the fact that the
holders were small in number, were sophisticated and were familiar with the
business of the Company.
In February 1995, the Company issued an additional $1,679,800 principal
amount of Bridge Notes and Bridge Warrants to acquire 239,971 shares of Common
Stock in a private placement transaction to 15 investors. Net proceeds were
approximately $1,537,000. The foregoing securities were issued in reliance upon
Section 4(2) of the Securities Act, based primarily upon the fact that the
holders were small in number, were sophisticated and were familiar with the
business of the Company.
In June 1995, the Company issued an additional $70,000 principal amount of
Bridge Notes and Bridge Warrants in a private placement transaction to three
investors. Net proceeds were approximately $64,400. The foregoing securities
were issued in reliance upon Section 4(2) of the Securities Act, based primarily
upon the fact that the holders were small in number, were sophisticated and were
familiar with the business of the Company.
2. Series A Convertible Preferred Stock. In April 1996, the Company issued
750,000 shares of Convertible Series A Preferred Stock ("Series A Preferred") in
a private placement transaction to 18 investors. Net proceeds were approximately
$6.8 million. This Series A Preferred was convertible into shares of Common
Stock based on a formula. As of the date of this Registration Statement, all
750,000 shares of Series A Preferred had converted into Common Stock. The
foregoing securities were issued in reliance upon Section 4(2) of the Securities
Act, based primarily upon the fact that the holders were smaller in number, were
sophisticated and were familiar with the business of the Company, and in
reliance upon Regulation S promulgated under the Securities Act.
3. In July 1997, the Company issued 1,547,827 shares of Common Stock in a
private placement transaction. Net proceeds were approximately $3,800,000. The
foregoing securities were issued in reliance upon Section 4(2) of the Securities
Act, based primarily upon the fact that the holders were small in number, were
sophisticated and were familiar with the business of the Company.
4. Before the Company's initial public offering in August 1995, the Company
issued certain options to require shares of Common Stock to a limited number of
employees and consultants. All of such issuances were under the Company's stock
option plan. No consideration was paid to the Company by any recipient of any of
the foregoing options for the grant of any such options. The options were
granted, and shares were issued upon exercise of such options, in reliance on
Section 4(2) of the Securities Act and Section 3(b) of the
II-2
<PAGE> 79
Securities Act and Rule 701 promulgated thereunder. The Company has also issued
common stock purchase warrants to a limited number of investor relations firms
and other consultants. No consideration was paid to the Company by any recipient
of any such warrants for the grant of such warrants. The warrants were issued in
reliance on Section 4(2) of the Securities Act, based primarily upon the fact
that the holders were small in number, were sophisticated and were familiar with
the business of the Company.
II-3
<PAGE> 80
ITEM 16. EXHIBITS.
The following exhibits are filed herewith or incorporated by reference
herein:
I. EXHIBITS
(a) The following exhibits are attached hereto or incorporated herein by
reference.
<TABLE>
<CAPTION>
EXHIBIT
NUMBER EXHIBIT TITLE
- ------ -----------------------------------------------------------------------------------
<C> <S>
1.1 Form of Underwriting Agreement.
3.1 Amended and Restated Articles of Incorporation of the Company. (Incorporated by
reference to Exhibit 3.2 to the Company's Registration Statement on Form SB-2
(Registration No. 33-93288 LA) declared effective on August 11, 1995 (the "SB-2")).
3.2 Bylaws of the Company. (Incorporated by reference to Exhibit 3.3 to the SB-2).
4.1 Specimen Common Stock Certificate. (Incorporated by reference to Exhibit 4.1 to the
SB-2).
4.2 Specimen Warrant Certificate. (Incorporated by reference to Exhibit 4.2 to the
SB-2).
4.3 Form of Underwriter Warrant.
5.1 Opinion of Fenwick & West LLP.
10.1 Barrier Repair Formulations License Agreement, dated October 26, 1993 between the
Company and the University of California. (Incorporated by reference to Exhibit
10.5 to the SB-2).
10.2 License Agreement, dated March 4, 1994, regarding Drug Delivery by Skin Barrier
Disruption, between the Company and University of California. (Incorporated by
reference to Exhibit 10.6 to the SB-2).
10.3 Agreement dated May 14, 1997, between the Company and the University of California.
(Confidential treatment has been requested with respect to the information
contained within the ["**"] markings. Such marked portions have been omitted from
this filing and have been filed separately with the Securities and Exchange
Commission).
10.4 Agreement dated October 6, 1997, between the Company and the University of
California. (Confidential treatment has been requested with respect to the
information contained within the ["**"] markings. Such marked portions have been
omitted from this filing and have been filed separately with the Securities and
Exchange Commission).
*10.5 Employment Agreement, dated as of January 21, 1996, between the Company and Dr.
Carl Thornfeldt. (Incorporated by reference to Exhibit 10.7 to the Company's Form
10-KSB for fiscal year ended December 31, 1995 (the "1995 Form 10-KSB").
10.6 Employment Agreement dated November 20, 1996, between the Company and K. Michael
Forrest. (Incorporated by reference to Exhibit 10.19 to the Company's Form 10-KSB
for the fiscal year ended December 31, 1996 (the "1996 Form 10-KSB").
10.7 Amended and Restated Registration Rights Agreement dated April 10, 1992.
(Incorporated by reference to Exhibit 10.11 to the SB-2).
10.8 Amended and Restated Registration Rights Agreement dated as of February 10, 1995.
(Incorporated by reference to Exhibit 10.14 to the SB-2).
10.9 1995 Equity Incentive Plan (Incorporated by reference to Exhibit 10.17 to the 1995
Form 10-KSB).
*10.10 1995 Directors' Stock Option Plan (Incorporated by reference to Exhibit 10.18 to
the 1995 Form 10-KSB).
10.11 Standard Industrial Lease dated April 6, 1992, between the Company and H&H
Management. (Incorporated by reference to Exhibit 10.20 to the 1995 Form 10-KSB).
</TABLE>
II-4
<PAGE> 81
<TABLE>
<CAPTION>
EXHIBIT
NUMBER EXHIBIT TITLE
- ------ -----------------------------------------------------------------------------------
<C> <S>
10.12 Exclusive Licensing Agreement for Glylorin between the Company and Glaxo Wellcome,
Inc. dated November 11, 1996. (Incorporated by reference to Exhibit 10.20 to the
1996 Form 10-KSB). (Confidential treatment has been requested with respect to the
information contained within the ["**"] markings. Such marked portions have been
omitted from this filing and have been filed separately with the Securities and
Exchange Commission).
*10.13 Consulting Agreement between the Company and Dr. Peter M. Elias dated May 1, 1996.
(Incorporated by reference to Exhibit 10.21 to the Form 10-KSB).
23.1 Consent of Ernst & Young LLP, Independent Auditors.
23.2 Consent of Fenwick & West LLP (contained in Exhibit 5.1).
24.1 Power of Attorney (See signature page).
</TABLE>
- ---------------
* Represents a management contract or compensatory plan or arrangement.
ITEM 17. UNDERTAKINGS.
Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of the
Registrant pursuant to the provisions described under Item 14 above, or
otherwise, the Registrant has been advised that in the opinion of the Securities
and Exchange Commission such indemnification is against public policy as
expressed in the Securities Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other than the
payment by the Registrant of expenses incurred or paid by a director, officer or
controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person
in connection with the securities being registered, the Registrant will, unless
in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in the
Securities Act and will be governed by the final adjudication of such issue.
The undersigned Registrant hereby undertakes:
(1) That, for the purpose of determining any liability under the
Securities Act, each post-effective amendment shall be deemed a
new registration statement relating to the securities offered
therein, and the offering of the securities at that time shall be
deemed to be the initial bona fide offering thereof.
(2) That, for purposes of determining any liability under the
Securities Act, each filing of the Registrant's annual report
pursuant to Section 13(a) or Section 15(d) of the Exchange Act
that is incorporated by reference in this Registration Statement
shall be deemed to be a new Registration Statement relating to the
securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering
thereof.
II-5
<PAGE> 82
SIGNATURES
In accordance with the requirements of the Securities Act of 1933, the
registrant certifies that it has reasonable grounds to believe that it meets all
of the requirements for filing on Form S-1 and authorized this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Foster City, State of California, on October 17,
1997.
CELLEGY PHARMACEUTICALS, INC.
By: /s/ K. MICHAEL FORREST
------------------------------------
K. Michael Forrest
President and Chief Executive
Officer
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS that each individual whose signature appears
below constitutes and appoints K. Michael Forrest and A. Richard Juelis, and
each of them, his true and lawful attorneys-in-fact and agents with full power
of substitution, for him and in his name, place and stead, in any and all
capacities, to sign any and all amendments (including post-effective amendments)
to this Registration Statement on Form S-1, and to file the same with all
exhibits thereto and all documents in connection therewith, with the Securities
and Exchange Commission, granting unto said attorneys-in-fact and agents, and
each of them, full power and authority to do and perform each and every act and
thing requisite and necessary to be done in and about the premises, as fully to
all intents and purposes as he might or could do in person, hereby ratifying and
confirming all of said attorneys-in-fact and agents, or any of them, or his or
their substitute or substitutes, may lawfully do or cause to be done by virtue
hereof.
In accordance with the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates stated.
<TABLE>
<CAPTION>
NAME TITLE DATE
- --------------------------------------------- ------------------------------ ------------------
<C> <S> <C>
PRINCIPAL EXECUTIVE OFFICER:
/s/ K. MICHAEL FORREST President, Chief Executive October 17, 1997
- --------------------------------------------- Officer and Director
K. Michael Forrest
PRINCIPAL FINANCIAL OFFICER AND PRINCIPAL
ACCOUNTING OFFICER:
/s/ A. RICHARD JUELIS Vice President, Finance, Chief October 17, 1997
- --------------------------------------------- Financial Officer and
A. Richard Juelis Secretary
DIRECTORS:
/s/ CARL R. THORNFELDT, M.D. Chairman of the Board of October 17, 1997
- --------------------------------------------- Directors
Carl R. Thornfeldt, M.D.
/s/ JACK L. BOWMAN Director October 17, 1997
- ---------------------------------------------
Jack L. Bowman
/s/ DENIS R. BURGER, PH.D. Director October 17, 1997
- ---------------------------------------------
Denis R. Burger, Ph.D.
/s/ TOBI B. KLAR, M.D. Director October 17, 1997
- ---------------------------------------------
Tobi B. Klar, M.D.
/s/ ALAN A. STEIGROD Director October 17, 1997
- ---------------------------------------------
Alan A. Steigrod
/s/ LARRY J. WELLS Director October 17, 1997
- ---------------------------------------------
Larry J. Wells
</TABLE>
II-6
<PAGE> 83
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT SEQUENTIALLY
NUMBER DESCRIPTION OF DOCUMENT NUMBERED PAGE
- ------ -------------------------------------------------------------------- -------------
<C> <S> <C>
1.1 Form of Underwriting Agreement.
3.1 Amended and Restated Articles of Incorporation of the Company.
(Incorporated by reference to Exhibit 3.2 to the Company's
Registration Statement on Form SB-2 (Registration No. 33-93288 LA)
declared effective on August 11, 1995 (the "SB-2")).
3.2 Bylaws of the Company. (Incorporated by reference to Exhibit 3.3 to
the SB-2).
4.1 Specimen Common Stock Certificate. (Incorporated by reference to
Exhibit 4.1 to the SB-2).
4.2 Specimen Warrant Certificate. (Incorporated by reference to Exhibit
4.2 to the SB-2).
4.3 Form of Underwriter Warrant.
5.1 Opinion of Fenwick & West LLP.
10.1 Barrier Repair Formulations License Agreement, dated October 26,
1993 between the Company and the University of California.
(Incorporated by reference to Exhibit 10.5 to the SB-2).
10.2 License Agreement, dated March 4, 1994, regarding Drug Delivery by
Skin Barrier Disruption, between the Company and University of
California. (Incorporated by reference to Exhibit 10.6 to the SB-2).
10.3 Agreement dated May 14, 1997, between the Company and the University
of California. (Confidential treatment has been requested with
respect to the information contained within the ["**"] markings.
Such marked portions have been omitted from this filing and have
been filed separately with the Securities and Exchange Commission).
10.4 Agreement dated October 6, 1997, between the Company and the
University of California. (Confidential treatment has been requested
with respect to the information contained within the ["**"]
markings. Such marked portions have been omitted from this filing
and have been filed separately with the Securities and Exchange
Commission).
*10.5 Employment Agreement, dated as of January 21, 1996, between the
Company and Dr. Carl Thornfeldt. (Incorporated by reference to
Exhibit 10.7 to the Company's Form 10-KSB for fiscal year ended
December 31, 1995 (the "1995 Form 10-KSB").
10.6 Employment Agreement dated November 20, 1996, between the Company
and K. Michael Forrest. (Incorporated by reference to Exhibit 10.19
to the Company's Form 10-KSB for the fiscal year ended December 31,
1996 (the "1996 Form 10-KSB").
10.7 Amended and Restated Registration Rights Agreement dated April 10,
1992. (Incorporated by reference to Exhibit 10.11 to the SB-2).
10.8 Amended and Restated Registration Rights Agreement dated as of
February 10, 1995. (Incorporated by reference to Exhibit 10.14 to
the SB-2).
10.9 1995 Equity Incentive Plan (Incorporated by reference to Exhibit
10.17 to the 1995 Form 10-KSB).
*10.10 1995 Directors' Stock Option Plan (Incorporated by reference to
Exhibit 10.18 to the 1995 Form 10-KSB).
10.11 Standard Industrial Lease dated April 6, 1992, between the Company
and H&H Management. (Incorporated by reference to Exhibit 10.20 to
the 1995 Form 10-KSB).
</TABLE>
<PAGE> 84
<TABLE>
<CAPTION>
EXHIBIT SEQUENTIALLY
NUMBER DESCRIPTION OF DOCUMENT NUMBERED PAGE
- ------ -------------------------------------------------------------------- -------------
<C> <S> <C>
10.12 Exclusive Licensing Agreement for Glylorin between the Company and
Glaxo Wellcome, Inc. dated November 11, 1996. (Incorporated by
reference to Exhibit 10.20 to the 1996 Form 10-KSB). (Confidential
treatment has been requested with respect to the information
contained within the ["**"] markings. Such marked portions have been
omitted from this filing and have been filed separately with the
Securities and Exchange Commission).
*10.13 Consulting Agreement between the Company and Dr. Peter M. Elias
dated May 1, 1996. (Incorporated by reference to Exhibit 10.21 to
the Form 10-KSB).
23.1 Consent of Ernst & Young LLP, Independent Auditors.
23.2 Consent of Fenwick & West LLP (contained in Exhibit 5.1).
24.1 Power of Attorney (See signature page).
</TABLE>
- ---------------
* Represents a management contract or compensatory plan or arrangement.
<PAGE> 1
EXHIBIT 1.1
2,250,000 Shares
CELLEGY PHARMACEUTICALS, INC.
Common Stock
[FORM OF]
UNDERWRITING AGREEMENT
_______ __, 1997
Oppenheimer & Co., Inc.
Oppenheimer Tower
World Financial Center
New York, New York 10281
Ladies and Gentlemen:
Cellegy Pharmaceuticals, Inc., a California corporation
(the "Company"), proposes to sell to you (the "Underwriter") an aggregate of
2,250,000 shares (the "Firm Shares") of the Company's Common Stock, no par
value (the "Common Stock"). In addition, the Company proposes to grant to the
Underwriters an option to purchase up to an additional 337,500 shares (the
"Option Shares") of Common Stock from it for the purpose of covering
over-allotments in connection with the sale of the Firm Shares. The Firm
Shares and the Option Shares are together called the "Shares."
The Company also proposes to issue to the Underwriter, the
warrants referred to in Section 1(c) to purchase up to an aggregate of 125,000
shares of Common Stock.
1. Sale and Purchase of the Shares. On the basis of
the representations, warranties and agreements contained in, and subject to the
terms and conditions of, this Agreement:
(a) The Company agrees to sell to the Underwriter, and
the Underwriter agrees to purchase from the Company, at $_____ per
share (the "Initial Price"), 2,250,000 Firm Shares.
(b) The Company grants to the Underwriter an option to
purchase all or any part of the Option Shares at the Initial Price.
Such option may be exercised only to cover over-allotments in the
sales of the Firm Shares by the Underwriter and may be exercised in
whole or in part at any time on or before 12:00 noon, New York City
time, on the business day before the Firm Shares Closing Date (as
defined below), and only once thereafter within 30 days after the
date of this Agreement, in each case upon written or telegraphic
notice, or verbal or telephonic notice confirmed by written or
telegraphic notice, by the Underwriter no later than 4:30 p.m., New
York City
<PAGE> 2
time, on the business day before the Firm Shares Closing Date or at
least two business days before the Option Shares Closing Date (as
defined below), as the case may be, setting forth the number of
Option Shares to be purchased and the time and date (if other than
the Firm Shares Closing Date) of such purchase.
(c) On the Firm Shares Closing Date, the Company agrees
to issue to the Underwriter a warrant (the "Warrant") to purchase
shares of Common Stock in an amount equal to 5% of the Firm Shares,
up to a maximum of 125,000 shares (the "Warrant Shares"). The
Warrant will have a five-year term and will be exercisable one year
from the Firm Shares Closing Date at an exercise price equal to 130%
of the Initial Price. The Warrant will be substantially identical to
the form of Warrant filed as an exhibit to the Registration
Statement (as defined below).
2. Delivery and Payment. Delivery by the Company of
the Firm Shares to the Underwriter and payment of the purchase price by wire
transfer, certified or official bank check or checks payable in New York
Clearing House (same day) funds to the Company, shall take place at the offices
of Oppenheimer & Co., Inc., at Oppenheimer Tower, World Financial Center, New
York, New York 10281, at 10:00 a.m., New York City time (a) on the third full
business day following the first day that the Shares are traded, (b) if this
Agreement is executed and delivered after 4:30 p.m. New York City time, on the
fourth business day following the date of this Agreement, or (c) at such other
time or date, but not later than the fourth full business day following the
Effective Date (as hereinafter defined), as shall be agreed upon by the Company
and the Underwriter (such time and date of delivery and payment are called the
"Firm Shares Closing Date").
In the event the option with respect to the Option Shares
is exercised, delivery by the Company of the Option Shares to the Underwriter
and payment of the purchase price by certified or official bank check or checks
payable in New York Clearing House (same day) funds to the Company shall take
place at the offices of Oppenheimer & Co., Inc. specified above at the time and
on the date (which may be the same date as, but in no event shall be earlier
than, the Firm Shares Closing Date) specified in the notice referred to in
Section 1(b) (such time and date of delivery and payment are called the "Option
Shares Closing Date"). The Firm Shares Closing Date and the Option Shares
Closing Date are called, individually, a "Closing Date" and, together, the
"Closing Dates."
Certificates evidencing the Shares shall be registered in
such names and shall be in such denominations as the Underwriter shall request
at least two full business days before the Firm Shares Closing Date or, in the
case of Option Shares, on the day of notice of exercise of the option as
described in Section l(b) and shall be made available to the Underwriter for
checking and packaging, at such place as is designated by the Underwriter, on
the full business
2.
<PAGE> 3
day before the Firm Shares Closing Date (or the Option Shares Closing Date in
the case of the Option Shares).
3. Registration Statement, Prospectus and Offering
Memorandum; Public Offering. The Company has prepared in conformity with the
requirements of the Securities Act of 1933, as amended (the "Securities Act"),
and the published rules and regulations thereunder (the "Rules") adopted by the
Securities and Exchange Commission (the "Commission") a registration statement
on Form S-1 (No. 333-_____), including a preliminary prospectus relating to the
Shares, and has filed with the Commission the Registration Statement (as
hereinafter defined) and such amendments thereof as may have been required to
the date of this Agreement. The number of executed copies requested by the
Underwriter of such Registration Statement (including all amendments thereof)
and of the related preliminary prospectus have heretofore been delivered by the
Company to the Underwriter. The term "preliminary prospectus" means any
preliminary prospectus (as described in Rule 430 of the Rules), including the
documents incorporated by reference therein, concluded at any time as a part of
the Registration Statement. The Registration Statement, as amended at the time
and on the date it became effective (the "Effective Date"), including all
documents incorporated by reference therein and all exhibits and information, if
any, deemed to be part of the Registration Statement pursuant to Rule 424(b),
Rule 430A, Rule 434 and Rule 462(b) of the Rules, is called the "Registration
Statement." The term "Prospectus" means the prospectus, including the documents
incorporated by reference therein, in the form first used to confirm sales of
the Shares (whether such prospectus was included in the Registration Statement
at the time of effectiveness or was subsequently filed with the Commission
pursuant to Rule 424(b) of the Rules).
The Company understands that the Underwriter proposes to
make a public offering of the Shares, as set forth in and pursuant to the
Prospectus, as soon after the Effective Date and the date of this Agreement as
the Underwriter deems advisable. The Company hereby confirms that the
Underwriter and dealers have been authorized to distribute or cause to be
distributed each preliminary prospectus and are authorized to distribute the
Prospectus (as from time to time amended or supplemented if the Company
furnishes amendments or supplements thereto to the Underwriter).
4. Representations and Warranties of the Company.
The Company hereby represents and warrants to the Underwriter as follows:
(a) On the Effective Date the Registration Statement
complied, and on the date of the Prospectus, on the date any
post-effective amendment to the Registration Statement shall become
effective, on the date any supplement or amendment to the
Prospectus is filed with the Commission and on each Closing Date,
the Registration Statement and the Prospectus (and any amendment
thereof or supplement thereto) will comply, in all material
respects, with the applicable provisions of the Securities Act and
the Rules and the Securities Exchange Act of 1934, as amended (the
"Exchange Act"), and the rules and regulations of the Commission
thereunder; the Registration Statement did not, as of the Effective
Date, contain any untrue statement of a material fact or omit to
state any material fact required to be stated therein or necessary
in order to make the
3.
<PAGE> 4
statements therein not misleading; and on the other dates referred
to above neither the Registration Statement nor the Prospectus, nor
any amendment thereof or supplement thereto, will contain any
untrue statement of a material fact or will omit to state any
material fact required to be stated therein or necessary in order
to make the statements therein not misleading. When any related
preliminary prospectus was first filed with the Commission (whether
filed as part of the Registration Statement or any amendment
thereto or pursuant to Rule 424(a) of the Rules) and when any
amendment thereof or supplement thereto was first filed with the
Commission, such preliminary prospectus as amended or supplemented
complied in all material respects with the applicable provisions of
the Securities Act and the Rules and did not contain any untrue
statement of a material fact or omit to state any material fact
required to be stated therein or necessary in order to make the
statements therein not misleading. Notwithstanding the foregoing,
the Company makes no representation or warranty as to the paragraph
with respect to stabilization on the inside front cover page of the
Prospectus and the statements contained under the caption
"Underwriting" in the Prospectus. The Company acknowledges that
the statements referred to in the previous sentence constitute the
only information furnished in writing by the Underwriter
specifically for inclusion in the Registration Statement, any
preliminary prospectus or the Prospectus.
(b) All contracts and other documents required to be
filed as exhibits to the Registration Statement have been filed
with the Commission as exhibits to the Registration Statement.
(c) The financial statements of the Company (including
all notes and schedules thereto) included in the Registration
Statement and Prospectus present fairly the financial position, the
results of operations and cash flows and the shareholders' equity
and the other information purported to be shown therein of the
Company at the respective dates and for the respective periods to
which they apply; and such financial statements have been prepared
in conformity with generally accepted accounting principles,
consistently applied throughout the periods involved, and all
adjustments necessary for a fair presentation of the results for
such periods have been made.
(d) Ernst & Young LLP, whose reports are filed with
the Commission as a part of the Registration Statement, are and,
during the periods covered by their reports, were independent
public accountants as required by the Securities Act and the Rules.
(e) The Company is a corporation duly organized,
validly existing and in good standing under the laws of the State
of California. The Company has no subsidiary or subsidiaries and
does not control, directly or indirectly, any corporation,
partnership, joint venture, association or other business
organization. The Company is duly qualified and in good standing
as a foreign corporation in each jurisdiction in which the
character or location of its assets or properties (owned, leased or
licensed)
4.
<PAGE> 5
or the nature of its business makes such qualification necessary
except for such jurisdictions where the failure to so qualify would
not have a material adverse effect on the assets or properties,
business, results of operations or financial condition of the
Company. Except as disclosed in the Registration Statement and the
Prospectus, the Company does not own, lease or license any asset or
property or conduct any business outside the United States of
America. The Company has all requisite corporate power and
authority, and all necessary authorizations, approvals, consents,
orders, licenses, certificates and permits of and from all
governmental or regulatory bodies or any other person or entity, to
own, lease and license its assets and properties and conduct its
businesses as now being conducted and as described in the
Registration Statement and the Prospectus except for such
authorizations, approvals, consents, orders, material licenses,
certificates and permits the failure to so obtain would not have a
material adverse effect upon the assets or properties, business,
results of operations, prospects or condition (financial or
otherwise) of the Company; no such authorization, approval,
consent, order, license, certificate or permit contains a
materially burdensome restriction other than as disclosed in the
Registration Statement and the Prospectus; and the Company has all
such corporate power and authority, and such authorizations,
approvals, consents, orders, licenses, certificates and permits to
enter into, deliver and perform this Agreement and to issue and
sell the Shares (except as may be required under the Securities Act
and state and foreign Blue Sky laws).
(f) The Company owns or possesses adequate and
enforceable rights to use all trademarks, trademark applications,
trade names, service marks, copyrights, copyright applications,
licenses, know-how and other similar rights and proprietary
knowledge (collectively, "Intangibles") necessary for the conduct
of its business as described in the Registration Statement and the
Prospectus. The Company has not received any notice of, or to its
best knowledge is not aware of, any infringement of or conflict
with asserted rights of others with respect to any Intangibles
which, singly or in the aggregate, if the subject of an unfavorable
decision, ruling or finding, would have a material adverse effect
upon the assets or properties, business, results of operations,
prospects or condition (financial or otherwise) of the Company.
(g) The Company has good and marketable title to each
of the items of personal property which are reflected in the
financial statements referred to in Section 4(c) or are referred to
in the Registration Statement and the Prospectus as being owned by
it and valid and enforceable leasehold interests in each of the
items of real and personal property which are referred to in the
Registration Statement and the Prospectus as being leased by it, in
each case free and clear of all liens, encumbrances, claims,
security interests and defects, other than those described in the
Registration Statement and the Prospectus and those which do not
and will not have a material adverse effect upon the assets or
properties, business, results of operations or financial condition
of the Company.
5.
<PAGE> 6
(h) There is no litigation or governmental or other
proceeding or investigation before any court or before or by any
public body or board pending or, to the Company's best knowledge,
threatened (and the Company does not know of any basis therefor)
against, or involving the assets, properties or business of, the
Company which would materially adversely affect the value or the
operation of any such assets or properties or the business, results
of operations, prospects or condition (financial or otherwise) of
the Company.
(i) Subsequent to the respective dates as of which
information is given in the Registration Statement and the
Prospectus, except as described therein, (i) there has not been
any material adverse change in the assets or properties, business,
results of operations, prospects or condition (financial or
otherwise), of the Company, whether or not arising from
transactions in the ordinary course of business; (ii) the Company
has not sustained any material loss or interference with its
assets, businesses or properties (whether owned or leased) from
fire, explosion, earthquake, flood or other calamity, whether or
not covered by insurance, or from any labor dispute or any court or
legislative or other governmental action, order or decree; and
(iii) and since the date of the latest balance sheet included in
the Registration Statement and the Prospectus, except as reflected
therein, the Company has not (a) issued any securities or incurred
any liability or obligation, direct or contingent, for borrowed
money, except such liabilities or obligations incurred in the
ordinary course of business, (b) entered into any transaction not
in the ordinary course of business or (c) declared or paid any
dividend or made any distribution on any shares of its stock or
redeemed, purchased or otherwise acquired or agreed to redeem,
purchase or otherwise acquire any shares of its stock.
(j) There is no document or contract of a character
required to be described in the Registration Statement or
Prospectus or to be filed as an exhibit to the Registration
Statement which is not described or filed as required. Each
agreement listed in the Exhibits to the Registration Statement is
in full force and effect and is valid and enforceable by and
against the Company in accordance with its terms, assuming the due
authorization, execution and delivery thereof by each of the other
parties thereto. Neither the Company, nor to the best of the
Company's knowledge, any other party is in default in the
observance or performance of any term or obligation to be performed
by it under any such agreement, and no event has occurred which
with notice or lapse of time or both would constitute such a
default, in any such case which default or event would have a
material adverse effect on the assets or properties, business,
results of operations, prospects or condition (financial or
otherwise) of the Company. No default exists, and no event has
occurred which with notice or lapse of time or both would
constitute a default, in the due performance and observance of any
term, covenant or condition, by the Company of any other agreement
or instrument to which the Company is a party or by which it or its
properties or business may be bound or affected which default or
event would have a material adverse effect on the assets or
6.
<PAGE> 7
properties, business, results of operations, prospects or condition
(financial or otherwise) of the Company.
(k) The Company is not in violation of any term or
provision of its charter or by-laws or of any franchise, license,
permit, judgment, decree, order, statute, rule or regulation, where
the consequences of such violation would have a material adverse
effect on the assets or properties, business, results of
operations, prospects or condition (financial or otherwise) of the
Company.
(l) Neither the execution, delivery and performance of
this Agreement and the Warrants by the Company nor the consummation
of any of the transactions contemplated hereby (including, without
limitation, the issuance and sale by the Company of the Shares and
the Warrants) will give rise to a right to terminate or accelerate
the due date of any payment due under, or conflict with or result
in the breach of any term or provision of, or constitute a default
(or an event which with notice or lapse of time or both would
constitute a default) under, or require any consent or waiver
under, or result in the execution or imposition of any lien, charge
or encumbrance upon any properties or assets of the Company
pursuant to the terms of, any indenture, mortgage, deed of trust or
other agreement or instrument to which the Company is a party or by
which it or any of its properties or businesses is bound, or any
franchise, license, permit, judgment, decree, order, statute, rule
or regulation applicable to the Company or violate any provision of
the charter or bylaws of the Company, except for such consents or
waivers which have already been obtained and are in full force and
effect.
(m) The Company has an authorized and outstanding
capital stock as set forth under the caption "Capitalization" in
the Prospectus. All of the outstanding shares of Common Stock have
been duly and validly issued and are fully paid and nonassessable
and none of them was issued in violation of any preemptive or other
similar right. The Company has reserved and kept available for the
exercise of the Warrants such number of authorized but unissued
shares as are sufficient to permit the exercise in full of the
Warrants. The Shares, when issued and sold pursuant to this
Agreement, and the Warrant shares, when issued and sold pursuant to
the Warrants, will be duly and validly issued, fully paid and
nonassessable and none of them will be issued in violation of any
preemptive or other similar right. Except as disclosed in the
Registration Statement and the Prospectus, there is no outstanding
option, warrant or other right calling for the issuance of, and
there is no commitment, plan or arrangement to issue, any share of
stock of the Company or any security convertible into, or
exercisable or exchangeable for, such stock. The Common Stock, the
Shares and the Warrants conform in all material respects to all
statements in relation thereto contained in the Registration
Statement and the Prospectus.
7.
<PAGE> 8
(n) No holder of any security of the Company has the
right to have any security owned by such holder included in the
Registration Statement or to demand registration of any security
owned by such holder during the period ending 120 days after the
date of this Agreement. Each shareholder, director and executive
officer of the Company has delivered to the Underwriter his or her
enforceable written agreement that he or she will not, for a period
of 120 days after the date of this Agreement, offer for sale, sell,
distribute, grant any option for the sale of, or otherwise dispose
of, directly or indirectly, or exercise any registration rights with
respect to, any shares of Common Stock (or any securities
convertible into, exercisable for, or exchangeable for any shares of
Common Stock) owned by him or her, without the prior written consent
of the Underwriter.
(o) All necessary corporate action has been duly and
validly taken by the Company to authorize the execution, delivery
and performance of this Agreement and the Warrants and the issuance
and sale of the Shares, the Warrants and the Warrant Shares by the
Company. This Agreement has been, and the Warrants on the Firm
Shares Closing Date will be, duly and validly authorized, executed
and delivered by the Company and will constitute legal, valid and
binding obligations of the Company enforceable against the Company
in accordance with their respective terms, except (A) as the
enforceability thereof may be limited by bankruptcy, insolvency,
reorganization, moratorium or other similar laws affecting the
enforcement of creditors' rights generally and by general equitable
principles and (B) to the extent that rights to indemnity or
contribution under this Agreement may be limited by federal and
state securities laws or the public policy underlying such laws.
(p) The Company is not involved in any labor dispute
nor, to the knowledge of the Company, is any such dispute
threatened, which dispute would have a material adverse effect on
the assets or properties, business, results of operations,
prospects or condition (financial or otherwise) of the Company.
(q) No transaction has occurred between or among the
Company and any of its officers or directors or any affiliate or
affiliates of any such officer or director that is required to be
described in and is not described in the Registration Statement and
the Prospectus.
(r) The Company has not taken, nor will it take,
directly or indirectly, any action designed to or which might
reasonably be expected to cause or result in, or which has
constituted or which might reasonably be expected to constitute,
the stabilization or manipulation of the price of the Common Stock
to facilitate the sale or resale of any of the Shares.
8.
<PAGE> 9
(s) The Company has filed all federal, state, local
and foreign tax returns which are required to be filed through the
date hereof, or has received extensions thereof, and has paid all
taxes shown on such returns and all assessments received by it to
the extent that the same are material and have become due.
(t) The books, records and accounts of the Company
accurately and fairly reflect, in reasonable detail, the
transactions in, and dispositions of, the assets of, and the
results of operations of, the Company. The Company maintains a
system of internal accounting controls sufficient to provide
reasonable assurances that (i) transactions are executed in
accordance with management's general or specific authorizations,
(ii) transactions are recorded as necessary to permit preparation
of financial statements in accordance with generally accepted
accounting principles and to maintain asset accountability, (iii)
access to assets is permitted only in accordance with management's
general or specific authorization and (iv) the recorded
accountability for assets is compared with the existing assets at
reasonable intervals and appropriate action is taken with respect
to any differences.
(u) Neither the Company nor any director, officer or
employee of the Company has, in the course of such person's actions
for, or on behalf of, the Company, used any corporate funds for any
unlawful contribution, gift, entertainment or other unlawful
expense relating to political activity or made any direct or
indirect unlawful payment to any foreign or domestic government
official or employee from corporate funds; and neither the Company,
nor to the Company's knowledge, any director, officer, employee,
agent or other person acting on behalf of the Company, has, in the
course of his actions for, or on behalf of, the Company violated or
is in violation of any provision of the Foreign Corrupt Practices
Act of 1977 or made any bribe, rebate, payoff, influence payment,
kickback or other unlawful payment.
(v) Each approval, consent, order, authorization,
designation, declaration or filing of, by or with any regulatory,
administrative or other governmental body necessary in connection
with the execution and delivery by the Company of this Agreement
and the consummation of the transactions herein contemplated
required to be obtained or performed by the Company (except such
additional steps as may be required by the National Association of
Securities Dealers, Inc. (the "NASD") or may be necessary to
qualify the Shares for public offering by the Underwriters under
the Securities Act or state securities or Blue Sky laws has been
obtained or made and is in full force and effect.
(w) The Shares have been duly authorized for quotation
on Nasdaq.
(x) There are no affiliations with the NASD among the
Company's officers, directors or, to the best of the knowledge of
the
9.
<PAGE> 10
Company, any shareholders of the Company, except as set forth in
the Registration Statement or otherwise disclosed to the
Representatives of the Underwriters.
(y) (i) The Company is in compliance in all material
respects with all rules, laws and regulation relating to the use,
treatment, storage and disposal of toxic substances and protection
of health or the environment ("Environmental Laws") which are
applicable to its business, (ii) the Company has not received any
notice from any governmental authority or third party of an
asserted claim under Environmental Laws, (iii) to the Company's
knowledge, no facts currently exist that will require the Company
to make future material capital expenditures to comply with
Environmental Laws, and (iv) no property which is or has been
owned, leased or occupied by the Company has been designated as a
Superfund site pursuant to the Comprehensive Environmental
Response, Compensation and Liability Act of 1980, as amended (42
U.S.C. Section 9601, et seq.), or otherwise designated as a
contaminated site under applicable state or local law.
(z) The Company is not an "investment company" within
the meaning of the Investment Company Act of 1940, as amended (the
"Investment Company Act").
5. Conditions of the Underwriter's Obligations. The
obligations of the Underwriter to purchase the Shares are subject
to each of the following terms and conditions:
(a) Notification that the Registration Statement has
become effective shall have been received by the Underwriter, and
the Prospectus shall have been timely filed with the Commission in
accordance with Section 6(a)(i) of this Agreement.
(b) No order preventing or suspending the use of any
preliminary prospectus or the Prospectus shall have been or shall
be in effect and no order suspending the effectiveness of the
Registration Statement shall be in effect and no proceedings for
such purpose shall be pending before or threatened by the
Commission, and any requests for additional information on the part
of the Commission (to be included in the Registration Statement or
the Prospectus or otherwise) shall have been complied with to the
satisfaction of the Underwriter.
(c) The representations and warranties of the Company
contained in this Agreement and in the certificates delivered
pursuant to Section 5(d) shall be true and correct when made and on
and as of each Closing Date as if made on such date and the Company
shall have performed all covenants and agreements and satisfied all
the conditions contained in this Agreement required to be performed
or satisfied by it at or before such Closing Date.
10.
<PAGE> 11
(d) The Underwriter shall have received on each
Closing Date a certificate, addressed to the Underwriter and dated
such Closing Date, of the chief executive or chief operating
officer of the Company to the effect that the signers of such
certificate have carefully examined the Registration Statement, the
Prospectus and this Agreement and that the representations and
warranties of the Company in this Agreement are true and correct on
and as of such Closing Date with the same effect as if made on such
Closing Date and the Company has performed all covenants and
agreements and satisfied all conditions contained in this Agreement
required to be performed or satisfied by it at or prior to such
Closing Date.
(e) The Underwriter shall have received on the
Effective Date, at the time this Agreement is executed and on each
Closing Date a signed letter from Ernst & Young LLP addressed to
the Underwriter and dated, respectively, the Effective Date, the
date of this Agreement and each such Closing Date, in form and
substance reasonably satisfactory to the Underwriter, confirming
that they are independent accountants within the meaning of the
Securities Act and the Rules, that the response to Item 10 of the
Registration Statement is correct insofar as it relates to them and
stating in effect that:
(i) in their opinion the audited financial
statements and financial statement schedules included in
the Registration Statement and the Prospectus and reported
on by them comply as to form in all material respects with
the applicable accounting requirements of the Securities
Act and the Rules;
(ii) on the basis of a reading of the amounts
included in the Registration Statement and the Prospectus
under the headings "Summary Financial Information" and
"Selected Financial Data," carrying out certain procedures
(but not an examination in accordance with generally
accepted auditing standards) which would not necessarily
reveal matters of significance with respect to the comments
set forth in such letter, a reading of the minutes of the
meetings of the shareholders and directors of the Company,
and inquiries of certain officials of the Company who have
responsibility for financial and accounting matters of the
Company as to transactions and events subsequent to the
date of the latest audited financial statements, except as
disclosed in the Registration Statement and the Prospectus,
nothing came to their attention which caused them to
believe that:
(A) the amounts in "Summary Financial
Information," and "Selected Financial Data"
included in the Registration Statement and the
Prospectus do not agree with the corresponding
amounts in the audited and unaudited financial
statements from which such amounts were derived;
or
11.
<PAGE> 12
(B) with respect to the Company, there
were, at a specified date not more than five
business days prior to the date of the letter, any
increases in the current liabilities and long-term
liabilities of the Company or any decreases in net
income or in working capital or the shareholders'
equity in the Company, as compared with the
amounts shown on the Company's audited balance
sheet for the fiscal year ended December 31, 1996
and the nine months ended September 30, 1997
included in the Registration Statement; and
(iii) they have performed certain other
procedures as a result of which they determined that
certain information of an accounting, financial or
statistical nature (which is limited to accounting,
financial or statistical information derived from the
general accounting records of the Company) set forth in the
Registration Statement and the Prospectus and reasonably
specified by the Underwriter agrees with the accounting
records of the Company.
References to the Registration Statement and the Prospectus
in this paragraph (e) are to such documents as amended and
supplemented at the date of the letter.
(f) The Underwriter shall have received on each
Closing Date from Fenwick & West LLP, counsel for the Company, an
opinion, addressed to the Underwriter and dated such Closing Date,
and stating in effect that:
(i) The Company has been duly organized and is
validly existing as a corporation in good standing under
the laws of the State of California. To the best of such
counsel's knowledge, the Company has no subsidiary and does
not control, directly or indirectly, any corporation,
partnership, joint venture, association or other business
organization. The Company is duly qualified and in good
standing as a foreign corporation in each jurisdiction in
which the character or location of its assets or properties
(owned, leased or licensed) or the nature of its businesses
makes such qualification necessary, except for such
jurisdictions where the failure to so qualify would not
have a material adverse effect on the assets or properties,
business, results of operations, prospects or condition
(financial or otherwise) of the Company.
(ii) The Company has all requisite corporate
power and authority to own, lease and license its assets
and properties and conduct its business as now being
conducted and as described in the Registration Statement
and the Prospectus; and the Company has all requisite
corporate power and authority and all necessary
authorizations, approvals, consents, orders, licenses,
certificates and permits to enter into, deliver and perform
this Agreement and
12.
<PAGE> 13
the Warrants and to issue and sell the Shares and the
Warrant Shares, other than those required under the
Securities Act and state and foreign Blue Sky laws.
(iii) The Company has authorized and issued
capital stock as set forth in the Registration Statement
and the Prospectus; the certificates evidencing the Shares
are in due and proper legal form and have been duly
authorized for issuance by the Company; all of the
outstanding shares of Common Stock of the Company have been
duly and validly authorized and have been duly and validly
issued and are fully paid and nonassessable and none of
them was issued in violation of any preemptive or other
similar right. The Warrant Shares have been duly
authorized and reserved by the Company. The Shares when
issued and sold pursuant to this Agreement and the Warrant
Shares, when sold and issued pursuant to the Warrants, will
be duly and validly issued, outstanding, fully paid and
nonassessable and none of them will have been issued in
violation of any preemptive or other similar right. To the
best of such counsel's knowledge, except as disclosed in
the Registration Statement and the Prospectus, there is no
outstanding option, warrant or other right calling for the
issuance of, and no commitment, plan or arrangement to
issue, any share of stock of the Company or any security
convertible into, exercisable for, or exchangeable for
stock of the Company. The Common Stock, the Shares and the
Warrants conform in all material respects to the
descriptions thereof contained in the Registration
Statement and the Prospectus.
(iv) To such counsel's knowledge, no holders of
securities of the Company have rights, which have not been
waived or complied with, to the registration of shares of
Common Stock or other securities, because of the filing of
the Registration Statement by the Company or the offering
contemplated hereby.
(v) All necessary corporate action has been duly
and validly taken by the Company to authorize the
execution, delivery and performance of this Agreement, the
execution, delivery and performance of the Warrants and the
issuance and sale of the Shares, the Warrants and the
Warrant Shares. This Agreement has been duly and validly
authorized, executed and delivered by the Company (and the
Warrants will have been duly and validly executed and
delivered by the Company when paid for on the Firm Shares
Closing Date) and this Agreement constitutes the legal,
valid and binding obligation of the Company enforceable
against the Company in accordance with their respective
terms except (A) as such enforceability may be limited by
applicable bankruptcy, insolvency, reorganization,
moratorium or other similar laws affecting the enforcement
of creditors' rights generally and by general equitable
principles and (B) to the extent that rights to indemnity
or contribution under
13.
<PAGE> 14
this Agreement may be limited by federal or state
securities laws or the public policy underlying such laws.
(vi) Neither the execution, delivery and
performance of this Agreement by the Company nor the
consummation of any of the transactions contemplated hereby
(including, without limitation, the issuance and sale by
the Company of the Shares and the Warrants) will give rise
to a right to terminate or accelerate the due date of any
payment due under, or conflict with or result in the breach
of any term or provision of, or constitute a default (or
any event which with notice or lapse of time, or both,
would constitute a default) under, or require consent or
waiver under, or result in the execution or imposition of
any lien, charge or encumbrance upon any properties or
assets of the Company pursuant to the terms of any
indenture, mortgage, deed trust, note or other agreement or
instrument of which such counsel is aware and to which the
Company is a party or by which it or any of its properties
or businesses is bound, or any franchise, license, permit,
judgment, decree, order, statute, rule or regulation of
which such counsel is aware or violate any provision of the
charter or bylaws of the Company.
(vii) To the best of such counsel's knowledge, no
default exists, and no event has occurred which with notice
or lapse of time, or both, would constitute a default, in
the due performance and observance of any term, covenant or
condition by the Company of any indenture, mortgage, deed
of trust, note or any other agreement or instrument to
which the Company is a party or by which it or any of its
assets or properties or businesses may be bound or
affected, where the consequences of such default would have
a material and adverse effect on the assets, properties,
business, results of operations, prospects or condition
(financial or otherwise) of the Company.
(viii) To the best of such counsel's knowledge,
the Company is not in violation of any term or provision of
its charter or bylaws or any franchise, license, permit,
judgment, decree, order, statute, rule or regulation, where
the consequences of such violation would have a material
and adverse effect on the assets or properties, businesses,
results of operations, prospects or condition (financial or
otherwise) of the Company.
(ix) No consent, approval, authorization or order
of any court or governmental agency or body is required for
the performance of this Agreement or the Warrants by the
Company or the consummation of the transactions
contemplated hereby or thereby, except such as have been
obtained under the Securities Act and such as may be
required under state securities or Blue Sky
14.
<PAGE> 15
laws in connection with the purchase and distribution of
the Shares by the Underwriter.
(x) To the best of such counsel's knowledge,
there is no litigation or governmental or other proceeding
or investigation, before any court or before or by any
public body or board pending or threatened against, or
involving the assets, properties or businesses of, the
Company which would have a material adverse effect upon the
assets or properties, business, results of operations,
prospects or condition (financial or otherwise) of the
Company.
(xi) The statements in the Prospectus and
Registration Statement under the captions
"_____________________" have been reviewed by such counsel
and are accurate in all material respects and fairly present
the information disclosed therein. All contracts and other
documents required to be filed as exhibits to, or described
in, the Registration Statement have been so filed with the
Commission or are fairly described in the Registration
Statement, as the case may be.
(xii) The statements in the Prospectus and
Registration Statement under the captions "Risk Factors -
Possible FDA Regulation of Cosmeceutical Products" and
"Business - Government Regulation," insofar as such
statements purport to summarize applicable provisions of
the Federal Food, Drug and Cosmetic Act, as amended, and
the regulations promulgated thereunder, are accurate
summaries in all material respects of the provisions
purported to be summarized under such captions.
(xiii) The Registration Statement has become
effective under the Securities Act, and, to such counsel's
knowledge, no stop order suspending the effectiveness of
the Registration Statement has been issued and no
proceedings for that purpose have been instituted or are
threatened, pending or contemplated; any required filing of
the Prospectus and any supplement thereto pursuant to Rule
424(b) of the Rules has been made in the manner and within
the time period required by Rule 424(b).
15.
<PAGE> 16
(xiv) The description of the capital stock of
the Company contained in the Registration Statement and the
Prospectus under the caption "Description of Capital Stock"
is accurate and complete.
(xv) The description of the Common Stock of the
Company contained in the Company's Form 8-A filed with the
Commission is accurate and complete.
(xvi) To such counsel's knowledge, the Shares
have been approved for quotation on the Nasdaq National
Market System.
To the extent deemed advisable by such counsel, they may
rely as to matters of fact on certificates of responsible officers of the
Company and public officials and on the opinions of other counsel satisfactory
to the Underwriter as to matters which are governed by laws other than the laws
of the State of New York, the General Corporation Law of the State of
California and the federal laws of the United States; provided that such
counsel shall state that in their opinion the Underwriter and they are
justified in relying on such other opinions. Copies of such certificates and
other opinions shall be furnished to the Underwriter and counsel for the
Underwriter.
In addition, such counsel shall state that such counsel has
participated in conferences with officers and other representatives of the
Company, representatives of the Underwriter and representatives of the
independent certified public accountants of the Company, at which conferences
the contents of the Registration Statement and the Prospectus and related
matters were discussed and, although such counsel is not passing upon and does
not assume any responsibility for the accuracy, completeness or fairness of the
statements contained in the Registration Statement and the Prospectus (except
as specified in the foregoing opinion), on the basis of the foregoing, no facts
have come to the attention of such counsel which lead such counsel to believe
that the Registration Statement at the time it became effective (except with
respect to the financial statements and notes and schedules thereto and other
financial data, as to which such counsel need express no belief) contained any
untrue statement of a material fact or omitted to state a material fact
required to be stated therein or necessary to make the statements therein not
misleading, or that the Prospectus as amended or supplemented (except with
respect to the financial statements and notes schedules thereto and other
financial data, as to which such counsel need make no statement) on the date
thereof contained any untrue statement of a material fact or omitted to state a
material fact necessary in order to make the statements therein, in the light
of the circumstances under which they were made, not misleading.
(g) The Underwriter shall have received on each
Closing Date from Townsend and Townsend and Crew, patent
counsel for the Company, an opinion addressed to the
Underwriter and dated such Closing Date, and stating in
effect that:
(i) The statements with respect to patent
matters in the Prospectus and Registration Statement under
the captions "Risk Factors - Patents and Proprietary
Technology" and "Business - Patents and Trade Secrets" have
been
16.
<PAGE> 17
reviewed by such patent counsel and are accurate in all
material respects and fairly present the information
disclosed therein.
(ii) To such patent counsel's knowledge, such
patent counsel believes the statements in the Registration
Statements and the Prospectus under the captions "Risk
Factors - Patents and Proprietary Technology" and "Business
- Patents and Trade Secrets" do not contain any untrue
statement of material fact, or do not omit to state any
material fact which would be required to be stated in the
Registration Statement and the Prospectus or are necessary
to make the statements therein not misleading.
(iii) Except as set forth in the Registration
Statement and the Prospectus, to such patent counsel's
knowledge, there is no claim or action by any person
pertaining to, or proceeding, pending or threatened, which
challenges the rights of the Company with respect to the
Company's patents or patent applications.
(h) All proceedings taken in connection with the sale
of the Firm Shares and the Option Shares as herein contemplated
shall be reasonably satisfactory in form and substance to the
Underwriter and its counsel and the Underwriter shall have received
from Cooley Godward LLP a favorable opinion, addressed to the
Underwriter and dated such Closing Date, with respect to the
Shares, the Registration Statement and the Prospectus, and such
other related matters, as the Underwriter may reasonably request,
and the Company shall have furnished to Cooley Godward LLP such
documents as they may reasonably request for the purpose of
enabling them to pass upon such matters.
(i) The Underwriter shall have received copies of the
Lock-up Agreements executed by each person described in Section
4(n).
(j) The Underwriter shall have received on each
Closing Date a certificate, addressed to the Underwriter, and dated
such Closing Date, of an executive officer of the Company to the
effect that the signer of such certificate has reviewed and
understands the provisions of Section 517.075 of the Florida
Statutes, and represents that the Company has complied, and at all
times will comply, with all provisions of Section 517.075 and
further, that as of such Closing Date, neither the Company nor any
of its affiliates does business with the government of Cuba or with
any person or affiliate located in Cuba.
6. Covenants of the Company.
(a) The Company covenants and agrees as follows:
17.
<PAGE> 18
(i) The Company shall prepare the Prospectus in a form
approved by the Underwriter and file such Prospectus pursuant to
Rule 424(b) under the Securities Act not later than the
Commission's close of business on the second business day following
the execution and delivery of this Agreement, or, if applicable,
such earlier time as may be required by Rule 430A(a)(3) under the
Securities Act, and shall promptly advise the Underwriter (A) when
any amendment to the Registration Statement shall have become
effective, (B) of any request by the Commission for any amendment
of the Registration Statement or the Prospectus or for any
additional information, (C) of the prevention or suspension of the
use of any preliminary prospectus or the Prospectus or of the
issuance by the Commission of any stop order suspending the
effectiveness of the Registration Statement or the institution or
threatening of any proceeding for that purpose and (D) of the
receipt by the Company of any notification with respect to the
suspension of the qualification of the Shares for sale in any
jurisdiction or the initiation or threatening of any proceeding for
such purpose. The Company shall not file any amendment of the
Registration Statement or supplement to the Prospectus unless the
Company has furnished the Underwriter a copy for its review prior
to filing and shall not file any such proposed amendment or
supplement to which the Underwriter reasonably objects. The
Company shall use its best efforts to prevent the issuance of any
such stop order and, if issued, to obtain as soon as possible the
withdrawal thereof.
(ii) If, at any time when a prospectus relating to the
Shares is required to be delivered under the Securities Act and the
Rules, any event occurs as a result of which the Prospectus as then
amended or supplemented would include any untrue statement of a
material fact or omit to state any material fact necessary to make
the statements therein in the light of the circumstances under
which they were made not misleading, or if it shall be necessary to
amend or supplement the Prospectus to comply with the Securities
Act or the Rules, the Company promptly shall prepare and file with
the Commission, subject to the second sentence of paragraph (i) of
this Section 6(a), an amendment or supplement which shall correct
such statement or omission or an amendment which shall effect such
compliance.
(iii) The Company shall make generally available to its
security holders and to the Underwriter as soon as practicable, but
not later than 45 days after the end of the 12-month period
beginning at the end of the fiscal quarter of the Company during
which the Effective Date occurs (or 90 days if such 12-month period
coincides with the Company's fiscal year), an earning statement
(which need not be audited) of the Company, covering such 12-month
period, which shall satisfy the provisions of Section 11(a) of the
Securities Act or Rule 158 of the Rules.
(iv) The Company shall furnish to the Underwriter and
counsel for the Underwriter, without charge, signed copies of the
Registration Statement (including all exhibits thereto and
amendments thereof) and, so long as delivery of a prospectus
18.
<PAGE> 19
by the Underwriter or dealer may be required by the Securities Act
or the Rules, as many copies of any preliminary prospectus and the
Prospectus and any amendments thereof and supplements thereto as
the Underwriter may reasonably request.
(v) The Company shall cooperate with the Underwriter
and its counsel in endeavoring to qualify the Shares for offer and
sale under the laws of such jurisdictions as the Underwriter may
designate and shall maintain such qualifications in effect so long
as required for the distribution of the Shares; provided, however,
that the Company shall not be required in connection therewith, as
a condition thereof, to qualify as a foreign corporation or to
execute a general consent to service of process in any jurisdiction
or subject itself to taxation as doing business in any
jurisdiction.
(vi) For a period of five years after the date of this
Agreement, the Company shall supply to the Underwriter, copies of
such financial statements and other periodic and special reports as
the Company may from time to time distribute generally to the
holders of any class of its capital stock and to furnish to the
Underwriter a copy of each annual or other report it shall be
required to file with the Commission.
(vii) Without the prior written consent of the
Underwriter, for a period of 120 days after the date of this
Agreement, the Company shall not issue, sell or register with the
Commission (other than on Form S-8 or on any successor form), or
otherwise dispose of, directly or indirectly, any equity securities
of the Company (or any securities convertible into or exercisable
or exchangeable for equity securities of the Company), except for
the issuance of the Shares pursuant to the Registration Statement
and the issuance of shares pursuant to the Company's existing stock
option plan or bonus plan. In the event that during this period,
(i) any shares are issued pursuant to the Company's existing stock
option plan or bonus plan or (ii) any registration is effected on
Form S-8 or on any successor form, the Company shall obtain the
written agreement of such grantee or purchaser or holder of such
registered securities that, for a period of 120 days after the
date of this Agreement, such person will not, without the prior
written consent of the Underwriter, offer for sale, sell,
distribute, grant any option for the sale of, or otherwise dispose
of, directly or indirectly, or exercise any registration rights
with respect to, any shares of Common Stock (or any securities
convertible into, exercisable for, or exchangeable for any shares
of Common Stock) owned by such person.
(viii) On or before completion of this offering, the
Company shall make all filings required under applicable securities
laws and by the Nasdaq National Market System (including any
required registration under the Exchange Act).
19.
<PAGE> 20
(b) The Company agrees to pay, or reimburse if paid by
the Underwriter, whether or not the transactions contemplated hereby are
consummated or this Agreement is terminated, all costs and expenses incident to
the public offering of the Shares and the performance of the obligations of the
Company under this Agreement including those relating to: (i) the preparation,
printing, filing and distribution of the Registration Statement including all
exhibits thereto, each preliminary prospectus, the Prospectus, all amendments
and supplements to the Registration Statement and the Prospectus, and the
printing, filing and distribution of this Agreement; (ii) the preparation and
delivery of certificates for the Shares to the Underwriter and the Warrants to
the Underwriter; (iii) the registration or qualification of the Shares for
offer and sale under the securities or Blue Sky laws of the various
jurisdictions referred to in Section 6(a)(v), including the reasonable fees and
disbursements of counsel for the Underwriter in connection with such
registration and qualification and the preparation, printing, distribution and
shipment of preliminary and supplementary Blue Sky memoranda; (iv) the
furnishing (including costs of shipping and mailing) to the Underwriter of
copies of each preliminary prospectus, the Prospectus and all amendments or
supplements to the Prospectus, and of the several documents required by this
Section to be so furnished, as may be reasonably requested for use in
connection with the offering and sale of the Shares by the Underwriter or by
dealers to whom Shares may be sold; (v) the filing fees of the National
Association of Securities Dealers, Inc. in connection with its review of the
terms of the public offering; (vi) the furnishing (including costs of shipping
and mailing) to the Underwriter of copies of all reports and information
required by Section 6(a)(vi); (vii) inclusion of the Shares for quotation on
the Nasdaq National Market System; and (viii) all transfer taxes, if any, with
respect to the sale and delivery of the Shares by the Company to the
Underwriters.
7. Indemnification.
(a) The Company agrees to indemnify and hold harmless
the Underwriter and each person, if any, who controls the
Underwriter within the meaning of Section 15 of the Securities Act
or Section 20 of the Exchange Act against any and all losses,
claims, damages and liabilities, joint or several (including any
reasonable investigation, legal and other expenses incurred in
connection with, and any amount paid in settlement of, any action,
suit or proceeding or any claim asserted), to which they, or any of
them, may become subject under the Securities Act, the Exchange Act
or other Federal or state law or regulation, at common law or
otherwise, insofar as such losses, claims, damages or liabilities
arise out of or are based upon any untrue statement or alleged
untrue statement of a material fact contained in any preliminary
prospectus, the Registration Statement or the Prospectus or any
amendment thereof or supplement thereto, or arise out of or are
based upon any omission or alleged omission to state
20.
<PAGE> 21
therein a material fact required to be stated therein or necessary
to make the statements therein not misleading; provided, however,
that such indemnity shall not inure to the benefit of the
Underwriter (or any person controlling such Underwriter) on account
of any losses, claims, damages or liabilities arising from the sale
of the Shares to any person by such Underwriter if such untrue
statement or omission or alleged untrue statement or omission was
made in such preliminary prospectus, the Registration Statement or
the Prospectus, or such amendment or supplement, in reliance upon
and in conformity with information furnished in writing to the
Company by the Underwriter specifically for use therein. This
indemnity agreement will be in addition to any liability which the
Company may otherwise have.
(b) The Underwriter agrees to indemnify and hold
harmless the Company, each person, if any, who controls the Company
within the meaning of Section 15 of the Securities Act or Section
20 of the Exchange Act, each director of the Company, and each
officer of the Company who signs the Registration Statement, to the
same extent as the foregoing indemnity from the Company to the
Underwriter, but only insofar as such losses, claims, damages or
liabilities arise out of or are based upon any untrue statement or
omission or alleged untrue statement or omission which was made in
any preliminary prospectus, the Registration Statement or the
Prospectus, or any amendment thereof or supplement thereto,
contained in the last paragraph of the cover page, in the paragraph
relating to stabilization on the inside front cover page of the
Prospectus and the statements contained under the caption
"Underwriting" in the Prospectus; provided, however, that the
obligation of the Underwriter to indemnify the Company (including
any controlling person, director or officer thereof) shall be
limited to the net proceeds received by the Company from the
Underwriter.
(c) Any party that proposes to assert the right to be
indemnified under this Section will, promptly after receipt of
notice of commencement of any action, suit or proceeding against
such party in respect of which a claim is to be made against an
indemnifying party or parties under this Section, notify each such
indemnifying party of the commencement of such action, suit or
proceeding, enclosing a copy of all papers served. No
indemnification provided for in Section 7(a) or 7(b) shall be
available to any party who shall fail to give notice as provided in
this Section 7(c) if the party to whom notice was not given was
unaware of the proceeding to which such notice would have related
and was prejudiced by the failure to give such notice but the
omission so to notify such indemnifying party of any such action,
suit or proceeding shall not relieve it from any liability that it
may have to any indemnified party for contribution or otherwise
than under this Section. In case any such action, suit or
proceeding shall be brought against any indemnified party and it
shall notify the indemnifying party of the commencement thereof,
the indemnifying party shall be entitled to participate in, and, to
the extent that it shall wish, jointly with any other indemnifying
party similarly
21.
<PAGE> 22
notified, to assume the defense thereof, with counsel reasonably
satisfactory to such indemnified party, and after notice from the
indemnifying party to such indemnified party of its election so to
assume the defense thereof and the approval by the indemnified
party of such counsel, the indemnifying party shall not be liable
to such indemnified party for any legal or other expenses, except
as provided below and except for the reasonable costs of
investigation subsequently incurred by such indemnified party in
connection with the defense thereof. The indemnified party shall
have the right to employ its counsel in any such action, but the
fees and expenses of such counsel shall be at the expense of such
indemnified party unless (i) the employment of counsel by such
indemnified party has been authorized in writing by the
indemnifying parties, (ii) the indemnified party shall have
reasonably concluded that there may be a conflict of interest
between the indemnifying parties and the indemnified party in the
conduct of the defense of such action (in which case the
indemnifying parties shall not have the right to direct the defense
of such action on behalf of the indemnified party) or (iii) the
indemnifying parties shall not have employed counsel to assume the
defense of such action within a reasonable time after notice of the
commencement thereof, in each of which cases the fees and expenses
of counsel shall be at the expense of the indemnifying parties. An
indemnifying party shall not be liable for any settlement of any
action, suit, proceeding or claim effected without its written
consent.
8. Contribution. In order to provide for just and
equitable contribution in circumstances in which the indemnification provided
for in Section 7(a) is due in accordance with its terms but for any reason is
held to be unavailable from the Company, the Company and the Underwriter shall
contribute to the aggregate losses, claims, damages and liabilities (including
any investigation, legal and other expenses reasonably incurred in connection
with, and any amount paid in settlement of, any action, suit or proceeding or
any claims asserted, but after deducting any contribution received by the
Company from persons other than the Underwriter, such as persons who control
the Company within the meaning of the Securities Act, officers of the Company
who signed the Registration Statement and directors of the Company, who may
also be liable for contribution) to which the Company, and the Underwriter may
be subject in such proportion as is appropriate to reflect the relative
benefits received by the Company on the one hand and the Underwriter on the
other from the offering of the Shares or, if such allocation is not permitted
by applicable law or indemnification is not available as a result of the
indemnifying party not having received notice as provided in Section 7 hereof,
in such proportion as is appropriate to reflect not only the relative benefits
referred to above but also the relative fault of the Company on the one hand
and the Underwriter on the other in connection with the statements or omissions
which resulted in such losses, claims, damages, liabilities or expenses, as
well as any other relevant equitable considerations. The relative benefits
received by the Company and the Underwriter shall be deemed to be in the same
proportion as (x) the total proceeds from the offering (net of underwriting
discounts but before deducting expenses) received by the Company, as set forth
in the table on the cover page of the Prospectus, bear to (y) the underwriting
discounts received by the Underwriter, as set forth in the table on the cover
page of the Prospectus. The
22.
<PAGE> 23
relative fault of the Company or the Underwriter shall be determined by
reference to, among other things, whether the untrue or alleged untrue
statement of a material fact related to information supplied by the Company or
the Underwriter and the parties' relative intent, knowledge, access to
information and opportunity to correct or prevent such statement or omission.
The Company and the Underwriter agree that it would not be just and equitable
if contribution pursuant to this Section 8 were determined by pro rata
allocation or by any other method of allocation which does not take account of
the equitable considerations referred to above. Notwithstanding the provisions
of this Section 8, (i) in no case shall the Underwriter be liable or
responsible for any amount in excess of the underwriting discount applicable to
the Shares purchased by the Underwriter hereunder, and (ii) the Company shall
be liable and responsible for any amount in excess of such underwriting
discount; provided, however, that no person guilty of fraudulent
misrepresentation (within the meaning of Section 11(f) of the Securities Act)
shall be entitled to contribution from any person who was not guilty of such
fraudulent misrepresentation. For purposes of this Section 8, each person, if
any, who controls the Underwriter within the meaning of Section 15 of the
Securities Act or Section 20(a) of the Exchange Act shall have the same rights
to contribution as such Underwriter, and each person, if any, who controls the
Company within the meaning of the Section 15 of the Securities Act or Section
20(a) of the Exchange Act, each officer of the Company who shall have signed
the Registration Statement and each director of the Company shall have the same
rights to contribution as the Company, subject in each case to clauses (i) and
(ii) in the immediately preceding sentence of this Section 8. Any party
entitled to contribution will, promptly after receipt of notice of commencement
of any action, suit or proceeding against such party in respect of which a
claim for contribution may be made against another party or parties under this
Section, notify such party or parties from whom contribution may be sought, but
the omission so to notify such party or parties from whom contribution may be
sought shall not relieve the party or parties from whom contribution may be
sought from any other obligation it or they may have hereunder or otherwise
than under this Section. No party shall be liable for contribution with
respect to any action, suit, proceeding or claim settled without its written
consent.
9. Termination. This Agreement may be terminated
with respect to the Shares to be purchased on a Closing Date by the Underwriter
by notifying the Company at any time:
(a) in the absolute discretion of the Underwriter at
or before any Closing Date: (i) if on or prior to such date, any
domestic or international event or act or occurrence has materially
disrupted, or in the opinion of the Underwriter will in the future
materially disrupt, the securities markets; (ii) if there has
occurred any new outbreak or material escalation of hostilities or
other calamity or crisis the effect of which on the financial
markets of the United States is such as to make it, in the judgment
of the Underwriter, inadvisable to proceed with the offering; (iii)
if there shall be such a material adverse change in general
financial, political or economic conditions or the effect of
international conditions on the financial markets in the United
23.
<PAGE> 24
States is such as to make it, in the judgment of the Underwriter,
inadvisable or impracticable to market the Shares; (iv) if trading
in the Shares has been suspended by the Commission or trading
generally on the New York Stock Exchange, Inc. or Nasdaq has been
suspended or limited, or minimum or maximum ranges for prices for
securities shall have been fixed, or maximum ranges for prices for
securities have been required, by said exchanges or by order of the
Commission, the National Association of Securities Dealers, Inc.,
or any other governmental or regulatory authority; or (v) if a
banking moratorium has been declared by any state or federal
authority, or
(b) at or before any Closing Date, that any of the
conditions specified in Section 5 shall not have been fulfilled
when and as required by this Agreement.
If this Agreement is terminated pursuant to any of its
provisions, the Company shall not be under any liability to the Underwriter,
and the Underwriter shall not be under any liability to the Company, except
that (y) if this Agreement is terminated by the Underwriter because of any
failure, refusal or inability on the part of the Company to comply with the
terms or to fulfill any of the conditions of this Agreement, the Company will
reimburse the Underwriter for all out-of-pocket expenses (including the
reasonable fees and disbursements of their counsel) incurred by them in
connection with the proposed purchase and sale of the Shares or in
contemplation of performing their obligations hereunder and (z) no Underwriter
who shall have failed or refused to purchase the Shares agreed to be purchased
by it under this Agreement, without some reason sufficient hereunder to justify
cancellation or termination of its obligations under this Agreement, shall be
relieved of liability to the Company for damages occasioned by its failure or
refusal.
10. Miscellaneous. The respective agreements,
representations, warranties, indemnities and other statements of the Company or
its officers and of the Underwriter set forth in or made pursuant to this
Agreement shall remain in full force and effect, regardless of any
investigation made by or on behalf of the Underwriter or the Company or any of
the officers, directors or controlling persons referred to in Sections 7 and 8
hereof, and shall survive delivery of and payment for the Shares. The
provisions of Sections 6(b), 7, 8 and 9 shall survive the termination or
cancellation of this Agreement.
This Agreement has been and is made for the benefit of the
Underwriter and the Company and their respective successors and assigns, and,
to the extent expressed herein, for the benefit of persons controlling the
Underwriter, or the Company, and directors and officers of the Company, and
their respective successors and assigns, and no other person shall acquire or
have any right under or by virtue of this Agreement. The term "successors and
assigns" shall not include any purchaser of Shares from the Underwriter merely
because of such purchase.
All notices and communications hereunder shall be in
writing and mailed or delivered or by telephone or telegraph if subsequently
confirmed in writing, (a) if to the
24.
<PAGE> 25
Underwriter, c/o Oppenheimer & Co., Inc., Oppenheimer Tower, World
Financial Center, New York, New York 10281 Attention: Peter J. Crowley, with a
copy to Lana K. Hawkins, Esq., Cooley Godward LLP, Five Palo Alto Square,
3000 El Camino Real, Palo Alto, California 94306-2155 and (b) if to the
Company, to its agent for service as such agent's address appears on the cover
page of the Registration Statement with a copy to C. Kevin Kelso, Esq., Fenwick
& West LLP, Two Palo Alto Square, Palo Alto, California 94306.
This Agreement shall be governed by and construed in
accordance with the laws of the State of New York without regard to principles
of conflict of laws.
This Agreement may be signed in any number of counterparts,
each of which shall be an original, with the same effect as if the signatures
thereto and hereto were upon the same instrument.
25.
<PAGE> 26
Please confirm that the foregoing correctly sets forth the
agreement among us.
Very truly yours,
CELLEGY PHARMACEUTICALS, INC.
By:
--------------------------------
Name:
------------------------------
Title:
-----------------------------
The foregoing Underwriting Agreement is
hereby confirmed and accepted as of the
date first above written:
OPPENHEIMER & CO., INC.
By:
--------------------------------
Name:
------------------------------
Title:
----------------------------
26.
<PAGE> 1
EXHIBIT 4.3
THE SECURITIES REPRESENTED BY THIS CERTIFICATE MAY NOT BE OFFERED FOR SALE,
SOLD OR OTHERWISE DISPOSED OF EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION
STATEMENT FILED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR PURSUANT TO AN
EXEMPTION FROM REGISTRATION UNDER SUCH ACT.
VOID AFTER 5:00 P.M., NEW YORK TIME, ON _______________ OR IF NOT A BUSINESS
DAY, AS DEFINED HEREIN, AT 5:00 P.M., NEW YORK TIME, ON THE NEXT FOLLOWING
BUSINESS DAY.
WARRANT TO PURCHASE
125,000 SHARES OF COMMON STOCK
NO. 1
WARRANT TO PURCHASE
COMMON STOCK
OF
CELLEGY PHARMACEUTICALS, INC.
TRANSFER RESTRICTED -- SEE SECTION 5.02
This certifies that, for good and valuable consideration, Oppenheimer &
Co., Inc., and its registered, permitted assigns (collectively, the
"Warrantholder") is entitled to purchase from Cellegy Pharmaceuticals, Inc., a
California corporation (the "Company"), subject to the terms and conditions
hereof, at any time on or after 9:00 A.M., New York time, on _______, 1997, and
before 5:00 P.M., New York time, on ______________, (or, is such day is not a
Business Day, at or before 5:00 P.M., New York time, on the next following
Business Day), the number of fully paid and non-assessable shares of Common
Stock stated above at the Exercise Price. The Exercise Price and the number of
shares purchasable hereunder are subject to adjustment from time to time as
provided in Article III hereof.
ARTICLE I
Section 1.01: Definition of Terms. As used in this Warrant, the
following capitalized terms shall have the following respective meanings:
(a) Business Day: A day other than a Saturday, Sunday or
other day on which banks in the State of New York are authorized by law to
remain closed.
(b) Common Stock: Common Stock, no par value per share,
of the Company.
(c) Common Stock Equivalents: Securities that are
convertible into or exercisable for shares of Common Stock.
(d) Demand Registration: See Section 6.02.
(e) Exchange Act: The Securities Exchange Act of 1934, as
amended.
<PAGE> 2
(f) Exercise Price: $_________ per Warrant Share, as such
price may be adjusted from time to time pursuant to Article III hereof.
(g) Expiration Date: 5:00 P.M., New York time, on
____________ or if such day is not a Business Day, the next succeeding day which
is a Business Day.
(h) 25% Holders: At any time as to which a Demand
registration is requested, the Holder and/or the holders of any other Warrants
and/or the holders of Warrant Shares who have the right to acquire or hold, as
the case may be, not less than 25% of the combined total of Warrant Shares
issuable and Warrant Shares outstanding at the time such Demand Registration is
requested.
(i) Holder: A Holder of Registrable Securities.
(j) NASD: National Association of Securities Dealers,
Inc., and NASDAQ: NASD Automatic Quotation System.
(k) Person: An individual, partnership, joint venture,
corporation, trust, unincorporated organization or government or any department
or agency thereof.
(l) Piggyback Registration: See Section 6.01.
(m) Prospectus: Any prospectus included in any
Registration Statement, as amended or supplemented by any prospectus
supplement, with respect to the terms of the offering of any portion of the
Registrable Securities covered by such Registration Statement and all other
amendments and supplements to the Prospectus, including post-effective
amendments and all materials incorporated by reference in such Prospectus.
(n) Public Offerings: A public offering of any of the
Company's equity or debt securities pursuant to a registration statement under
the Securities Act.
(o) Registration Expenses: Any and all expenses incurred
in connection with any registration or action incident to performance of or
compliance by the Company with Article VI, including, without limitation, (i)
all SEC, national securities exchange and NASD registration and filing fees; all
listing fees and all transfer agent fees; (ii) all fees and expenses of
complying with state securities or blue sky laws (including the fees and
disbursements of counsel for the underwriters in connection with blue sky
qualifications of the Registrable Securities; (iii) all printing, mailing,
messenger and delivery expenses and (iv) all fees and disbursements of counsel
for the Company and of its accountants, including the expenses of any special
audits and/or "cold comfort" letters required by or incident to such
performance and compliance, but excluding underwriting discounts and
commissions, brokerage fees and transfer taxes, if any, and fees of counsel or
accountants retained by the holders of Registrable Securities to advise them in
their capacity as Holders of Registrable Securities.
(p) Registrable Securities. Any Warrant Shares issued to
Oppenheimer & Co., Inc. and/or its designees or transferees as permitted under
Section 5.02 and/or other securities that may be or are issued by the Company
upon exercise of this Warrant, including those which may thereafter be issued
by the Company in respect of any such securities by means of any stock splits,
stock dividends, recapitalizations, reclassifications or the like, and as
adjusted pursuant to Article III hereof.
2
<PAGE> 3
(q) Registration Statement: Any registration statement of the
Company filed or to be filed with the SEC which covers any of the Registrable
Securities pursuant to the provisions of this Agreement, including all
amendments (including post-effective amendments) and supplements thereto, all
exhibits thereto and all material incorporated therein by reference.
(r) SEC: The Securities and Exchange Commission or any other
federal agency at the time administering the Securities Act or the Exchange Act.
(s) Securities Act: The Securities Act of 1933, as amended.
(t) Transfers: See Section 5.02.
(u) Warrants: This Warrant, all other warrants issued on the
date hereof and all other warrants that may be issued in its or their place
(together evidencing the right to purchase an aggregate of [ ] shares of
Common Stock), originally issued as set forth in the definition of Registrable
Securities.
(v) Warrantholder: The person(s) or entity(ies) to whom this
Warrant is originally issued, or any successor in interest thereto, or any
assignee or transferee thereof, in whose name this Warrant is registered upon
the books to be maintained by the Company for that purpose.
(w) Warrant Shares: Common Stock, Common Stock Equivalents
and other securities purchased or purchasable upon exercise of the Warrants.
ARTICLE II
Duration and Exercise of Warrant
Section 2.01: Duration of Warrant. Subject to the limitations
specified in Section 2.02.(a)(ii) regarding a Cashless Exercise, the
Warrantholder may exercise this Warrant at any time and from time to time after
9:00 A.M., New York time, on ________, 1997, and before 5:00 P.M., New York
time, on the Expiration Date. If this Warrant is not exercised on or prior to
the Expiration Date, it shall become void, and all rights hereunder shall
thereupon cease.
Section 2.02: Exercise of Warrant.
(a) The Warrantholder may exercise this Warrant, in whole or in
part, as follows:
(i) By presentation and surrender of this Warrant to the
Company at its principal executive offices or at the office of
its stock transfer agent, if any, with the Subscription Form
annexed hereto duly executed and accompanied by payment of the
full Exercise Price for each Warrant Share to be purchased; or
(ii) By presentation and surrender of this Warrant to the
Company at its principal executive offices with a Cashless
Exercise Form annexed hereto duly executed
3
<PAGE> 4
(a "Cashless Exercise"). In the event of a Cashless Exercise,
the Warrantholder shall exchange its warrant for that number of
shares of Common Stock determined by multiplying the number of
Warrant Shares by a fraction, the numerator of which shall be
the amount by which the then current market price per share of
Common Stock exceeds the Exercise Price, and the denominator of
which shall be the then current market price per share of Common
Stock. For purposes of any computation under this Section
2.02(a)(ii), the then current market price per share of Common
Stock at any date shall be deemed to be the last sale price of
the Common Stock on the business day prior to the date of the
Cashless Exercise or, in case no such reported sales take place
on such day, the average of the last reported bid and asked
prices of the Common Stock on such day, in either case on the
principal national securities exchange on which the Common
Stock is admitted to trading or listed, or if not listed or
admitted to trading on any such exchange, the representative
closing bid price of the Common Stock as reported by NASDAQ, or
other similar organization if NASDAQ is no longer reporting such
information, or if not so available, the fair market price of
the Common Stock as determined by the Board of Directors.
(b) Upon receipt of this Warrant, in the case of Section
2.02(a)(i), with the Subscription Form duly executed and accompanied by
payment of the aggregate Exercise Price for the Warrant Shares for which this
Warrant is then being exercised, or, in the case of Section 2.02(a)(ii), with
the Cashless Exercise Form duly executed, the Company shall cause to be issued
certificates for the total number of whole shares of Common Stock for which this
Warrant is being exercised (adjusted to reflect the effect of the anti-dilution
provisions contained in Article III hereof, if any, and as provided in Section
2.04 hereof) in such denominations as are required for delivery to the
Warrantholder, and the Company shall thereupon deliver such certificates to the
Warrantholder. The Warrantholder shall be deemed to be the holder of record of
the shares of Common Stock issuable upon such exercise, notwithstanding that the
stock transfer books of the Company shall then be closed or that certificates
representing such shares of Common Stock shall not then be actually delivered to
the Warrantholder. If at the time this Warrant is exercised, a Registration
Statement is not in effect to register under the Securities Act the Warrant
Shares issuable upon exercise of this Warrant, the Company may require the
Warrantholder to make such representations, and may place such legends on
certificates representing the Warrant Shares, as may be reasonably required in
the opinion of counsel to the Company to permit the Warrant Shares to be issued
without such registration.
(c) In case the Warrantholder shall exercise this Warrant
with respect to less than all of the Warrant Shares that may be purchased under
this Warrant, the Company shall execute a new warrant in the form of this
Warrant for the balance of such Warrant Shares and deliver such new warrant to
the Warrantholder.
(d) The Company shall pay any and all stock transfer and
similar taxes which may be payable in respect of the issue of this Warrant or in
respect of the issue of any Warrant Shares.
Section 2.03: Reservation of Shares. The Company hereby agrees that
at all times there shall be reserved for issuance and delivery upon exercise of
this Warrant such number of shares of Common Stock or other shares of capital
stock of the Company from time to time issuable upon exercise of this Warrant.
All such shares shall be duly authorized, and when issued upon such exercise,
shall be validly issued, fully paid and nonassessable, free and clear of all
liens, security interests, charges and other
4
<PAGE> 5
encumbrances or restrictions on sale and free and clear of all preemptive rights
(except the restrictions imposed by the legend appearing at the top of Page 1
of this Warrant).
Section 2.04: Fractional Shares. The Company shall not be required
to issue any fraction of a share of its capital stock in connection with the
exercise of this Warrant, and in any case where the Warrantholder would, except
for the provisions of this Section 2.04, be entitled under the terms of this
Warrant to receive a fraction of a share upon the exercise of this Warrant, the
Company shall, upon the exercise of this Warrant and tender of the Exercise
Price (as adjusted to cover the balance of the share), issue the larger number
of whole shares purchasable upon exercise of this Warrant. The Company shall
not be required to make any cash or other adjustment in respect of such
fraction of a share to which the Warrantholder would otherwise be entitled.
Section 2.05: Listing. Prior to the issuance of any shares of Common
Stock upon exercise of this Warrant, the Company shall secure the listing of
such shares of Common Stock upon each national securities exchange or automated
quotation system, if any, upon which shares of Common Stock are then listed
(subject to official notice of issuance upon exercise of this Warrant) and shall
maintain, so long as any other shares of Common Stock shall so be listed, such
listing of all shares of Common Stock from time to time issuable upon the
exercise of this Warrant; and the Company shall so list on each national
securities exchange or automated quotation system, and shall maintain such
listing of, any other shares of capital stock of the Company issuable upon the
exercise of this Warrant if and so long as any shares of the same class shall be
listed on such national securities exchange or automated quotation system.
ARTICLE III
Adjustment of Shares of Common Stock
Purchasable and of Exercise Price
The Exercise Price and the number and kind of Warrant Shares shall be
subject to adjustment from time to time upon the happening of certain events as
provided in this Article III.
Section 3.01: Mechanical Adjustments. (a) If at any time prior to the
exercise of this Warrant in full, the Company shall (i) declare a dividend or
make a distribution on the Common Stock payable in shares of its capital
(whether shares of Common Stock or of capital stock of any other class); (ii)
subdivide, reclassify or recapitalize outstanding Common Stock into a greater
number of shares; (iii) combine, reclassify or recapitalize its outstanding
Common Stock into a smaller number of shares; or (iv) issue any shares of its
capital stock by reclassification of its Common Stock (including any such
reclassification in connection with a consolidation or a merger in which the
Company is the continuing corporation), the Exercise Price in effect at the time
of the record date of such dividend, distribution, subdivision, combination,
reclassification or recapitalization shall be adjusted so that the Warrantholder
shall be entitled to receive the aggregate number and kind of shares which, if
this Warrant had been exercised in full immediately prior to such event, he
would have owned upon such exercise and been entitled to receive by virtue of
such dividend, distribution, subdivision, combination, reclassification or
recapitalization. Any adjustment required by this paragraph 3.01(a) shall be
made successively immediately after the record date, in the case of a dividend
or distribution, or the effective date, in the case of a subdivision,
combination, reclassification or recapitalization to allow the purchase of such
aggregate number and kind of shares.
5
<PAGE> 6
(b) If at any time after ________, _____ and prior to the exercise
of this Warrant in full, the Company shall (i) issue or sell any Common Stock or
Common Stock Equivalents without consideration or for consideration per share
(in cash, property or other assets) less than the current market price per share
on the date of such issuance or sale as defined in Section 3.01(f) (except for
the issuance of any Common Stock or Common Stock Equivalents pursuant to any
options, warrants, rights or other agreements in effect prior to ________,
_____) or (ii) fix a record date for the issuance of subscription rights,
options or warrants to all holders of Common Stock entitling them to subscribe
for or purchase Common Stock (or Common Stock Equivalents) at a price (or having
an exercise or conversion price per share) less than the current market price of
the Common Stock (as determined pursuant to Section 3.01(f)) on the record date
described below, the Exercise Price shall be adjusted so that the Exercise Price
shall equal the price determined by multiplying the Exercise Price in effect
immediately prior to the date of such sale or issuance (which date in the event
of distribution to shareholders shall be deemed to be the record date set by the
Company to determine shareholders entitled to participate in such distribution)
by a fraction, the numerator of which shall be (i) the number of shares of
Common Stock outstanding on the date of such sale or issuance, plus (ii) the
number of additional shares of Common Stock which the aggregate consideration
received by the Company upon such issuance or sale (plus the aggregate of any
additional amount to be received by the Company upon the exercise of such
subscription rights, options or warrants) would purchase at such current market
price per share of the Common Stock; and the denominator of which shall be (i)
the number of shares of Common Stock outstanding on the date of such issuance or
sale, plus (ii) the number of additional shares of Common Stock offered for
subscription or purchase (or into which the Common Stock Equivalents so offered
are exercisable or convertible). Any adjustments required by this paragraph
3.01(b) shall be made immediately after such issuance or sale or record date, as
the case may be. Such adjustments shall be made successively whenever such event
shall occur. To the extent that shares of Common Stock (or Common Stock
Equivalents) are not delivered in connection with such subscription rights,
options or warrants, the Exercise Price shall be readjusted to the Exercise
Price which would then be in effect had the adjustments made upon the issuance
of such rights, options or warrants been made upon the basis of delivery of only
the number of shares of Common Stock (or Common Stock Equivalents) actually
delivered.
(c) If at any time prior to the exercise of this Warrant in full,
the Company shall fix a record date for the issuance or making a distribution
to all holders of Common Stock (including any such distribution to be made in
connection with a consolidation or merger in which the Company is to be the
continuing corporation) of evidences of its indebtedness, any other securities
of the Company or any cash, property or other assets (excluding a combination,
reclassification or recapitalization referred to in Section 3.01(a), regular
cash dividends or cash distributions paid out of net profits legally available
therefor and in the ordinary course of business and subscription rights,
options or warrants for Common Stock or Common Stock Equivalents (excluding
those referred to in Section 3.01(b)) (any such nonexcluded event being herein
called a "Special Dividend"), (i) the Exercise Price shall be decreased
immediately after the record date for such Special Dividend to a price
determined by multiplying the Exercise Price then in effect by a fraction, the
numerator of which shall be the then current market price of the Common Stock
(as defined in Section 3.01(f)) on such record date less the fair market value
(as determined by the Company's Board of Directors) of the evidences of
indebtedness, securities or property, or other assets issued or distributed in
such Special Dividend applicable to one share of Common Stock or of such
subscription rights, options or warrants applicable to one share of Common
Stock and the denominator of which shall be such then current market price per
share of Common Stock (as so determined) and (ii) the number of shares of
Common Stock subject to purchase upon exercise of this Warrant shall be
increased to a number determined by multiplying the number of shares of Common
Stock subject to purchase immediately before
6
<PAGE> 7
such Special Dividend by a fraction, the numerator of which shall be the
Exercise Price in effect immediately before such Special Dividend and the
denominator of which shall be the Exercise Price in effect immediately after
such Special Dividend. Any adjustment required by this paragraph 3.01(c) shall
be made successively whenever such a record date is fixed and in the event that
such distribution is not so made, the Exercise Price shall again be adjusted to
be the Exercise Price that was in effect immediately prior to such record date.
(d) If at any time prior to the exercise of this Warrant in full, the
Company shall make a distribution to all holders of the Common Stock of stock
of a subsidiary or securities convertible into or exercisable for such stock,
then in lieu of an adjustment in the Exercise Price or the number of Warrant
Shares purchasable upon the exercise of this warrant, each Warrantholder, upon
the exercise hereof at any time after such distribution, shall be entitled to
receive from the Company, such subsidiary or both, as the Company shall
determine, the stock or other securities to which such Warrantholder would have
been entitled if such Warrantholder had exercised this Warrant immediately
prior thereto, all subject to further adjustment as provided in this Article
III, and the Company shall reserve, for the life of the Warrant, such
securities of such subsidiary or other corporation; provided, however, that no
adjustment in respect of dividends or interest on such stock or other
securities shall be made during the term of this Warrant or upon its exercise.
(e) Whenever the Exercise Price payable upon exercise of each Warrant
is adjusted pursuant to one or more of paragraphs (a), (b) and (c) of this
Section 3.01, the Warrant Shares shall simultaneously be adjusted by
multiplying the number of Warrant Shares initially issuable upon exercise of
each Warrant by the Exercise Price in effect on the date of such adjustment and
dividing the product so obtained by the Exercise Price, as adjusted.
(f) For the purpose of any computation under this Section 3.01, the
current market price per share of Common Stock at any date shall be deemed to
be the average of the daily closing prices for 20 consecutive trading days
commencing 30 trading days before such date. The closing price for each day
shall be the last sale price regular way or, in case no such reported sales
take place on such day, the average of the last reported bid and asked prices
regular way, in either case on the principal national securities exchange on
which the Common Stock is admitted to trading or listed, or if not listed or
admitted to trading on any such exchange, the representative closing bid price
as reported by NASDAQ, or other similar organization if NASDAQ is no longer
reporting such information, or if not so available, the fair market price as
determined by the Board of Directors of the Company.
(g) No adjustment in the Exercise Price shall be required unless such
adjustment would require an increase or decrease of at least ten cents ($.10)
in such price; provided, however, that any adjustments which by reason of this
paragraph (g) are not required to be made shall be carried forward and taken
into account in any subsequent adjustment. All calculations under this Section
3.01 shall be made to the nearest cent or to the nearest one-hundredth of a
share, as the case may be. Notwithstanding anything in this Section 3.01 to the
contrary, the Exercise Price shall not be reduced to less than the then
existing par value of the Common Stock as a result of any adjustment made
hereunder.
(h) In the event that at any time, as a result of any adjustment made
pursuant to Section 3.01(a), the Warrantholder thereafter shall become entitled
to receive any shares of the Company other than Common Stock, thereafter the
number of such other shares so receivable upon exercise of any Warrant shall be
subject to adjustment from time to time in a manner and on terms as nearly
equivalent as
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<PAGE> 8
practicable to the provisions with respect to the Common Stock contained in
Section 3.01(a).
(i) In the case of an issue of additional Common Stock or
Common Stock Equivalents for cash, the consideration received by the Company
therefor, after deducting therefrom any discount or commission or other expenses
paid by the Company for any underwriting of, or otherwise in connection with,
the issuance thereof, shall be deemed to be the amount received by the Company
therefor. The term "issue" shall include the sale or other disposition of shares
held by or on account of the Company or in the treasury of the Company but until
so sold or otherwise disposed of such shares shall not be deemed outstanding.
Section 3.02: Notice of Adjustment. Whenever the number of Warrant
Shares or the Exercise Price is adjusted as herein provided, the Company shall
prepare and deliver forthwith to the Warrantholder a certificate signed by its
President, and by any Vice President, Treasurer or Secretary, setting forth the
adjusted number of shares purchasable upon the exercise of this Warrant and the
Exercise Price of such shares after such adjustment, a brief statement of the
facts requiring such adjustment and the computation by which adjustment was
made.
Section 3.03: No Adjustment for Dividends. Except as provided in
Section 3.01 of this Agreement, no adjustment in respect of any cash dividends
paid by the Company shall be made during the term of this Warrant or upon the
exercise of this Warrant.
Section 3.04: Preservation of Purchase Rights in Certain Transactions.
In cash of any reclassification, capital reorganization or other change of
outstanding shares of Common Stock (other than a subdivision or a combination
of the outstanding Common Stock and other than a change in the par value of the
Common Stock or in case of any consolidation or merger of the Company with or
into another corporation (other than a merger with a subsidiary in which the
Company is the continuing corporation and said merger does not result in any
reclassification, capital reorganization or other change of outstanding shares
of Common Stock of the class issuable upon exercise of this Warrant)) or in
case of any sale, lease, transfer or conveyance to another corporation of the
property and assets of the Company as an entirety or substantially as an
entirety, the Company shall, as a condition precedent to such transaction,
cause such successor or purchasing corporation, as the case may be, to execute
with the Warrantholder an agreement granting the Warrantholder the right
thereafter, upon payment of the Exercise Price in effect immediately prior to
such action, to receive upon exercise of this Warrant the kind and amount of
shares and other securities and property which he would have owned or have been
entitled to receive after the happening of such reclassification, change,
consolidation, merger, sale or conveyance had this Warrant been exercised
immediately prior to such action. Such agreement shall provide for adjustments
in respect of such shares of stock and other securities and property, which
shall be as nearly equivalent as may be practicable to the adjustments provided
for in this Article III. In the event that in connection with any such
reclassification, capital reorganizations, change, consolidation, merger, sale
or conveyance, additional shares of Common Stock shall be issued in exchange,
conversion, substitution or payment, in whole or in part, for, or of, a
security of the Company other than Common Stock, any such issue shall be
treated as an issue of Common Stock covered by the provisions of Article III.
The provisions of this Section 3.04 shall similarly apply to successive
reclassification, capital reorganization, consolidations, mergers, sales or
conveyances.
Section 3.05: Form of Warrant After Adjustments. The form of this
Warrant need not be changed because of any adjustments in the Exercise Price or
the number or kind of the Warrant Shares, and Warrants theretofore or
thereafter issued may continue to express the same price and number and kind
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<PAGE> 9
of shares as are stated in this Warrant, as initially issued.
Section 3.06: Treatment of Warrantholder. Prior to due presentment
for registration of transfer of this Warrant, the Company may deem and treat the
Warrantholder as the absolute owner of this Warrant (notwithstanding any
notation of ownership or other writing hereon) for all purposes and shall not
be affected by any notice to the contrary.
ARTICLE IV
Other Provisions Relating
to Rights of Warrantholder
Section 4.01: No Rights as Shareholders; Notice to Warrantholders.
Nothing contained in this Warrant shall be construed as conferring upon the
Warrantholder or his or its transferees the right to vote or to receive
dividends or to consent to or receive notice as a shareholder in respect of any
meeting of shareholders for the election of directors of the Company or any
other matter, or any other rights whatsoever as shareholders of the Company.
The Company shall give notice to the Warrantholder by registered mail if at any
time prior to the expiration or excise in full of the Warrants, any of the
following events shall occur:
(a) the Company shall authorize the payment of any dividend
upon shares of Common Stock payable in any securities or authorize the making
of any distribution (other than a cash dividend subject to the parenthetical set
forth in Section 3.01(c)) to all holders of Common Stock;
(b) the Company shall authorize the issuance to all holders
of Common Stock of any additional shares of Common Stock or Common Stock
Equivalents or of rights, options or warrants to subscribe for or purchase
Common Stock or Common Stock Equivalents or of any other subscription rights,
options or warrants;
(c) a dissolution, liquidation or winding up of the Company
(other than in connection with a consolidation, merger, or sale or conveyance
of the property of the Company as an entirety or substantially as an entirety);
or
(d) a capital reorganization or reclassification of the
Common Stock (other than a subdivision or combination of the outstanding Common
Stock and other than a change in the par value of the Common Stock) or any
consolidation or merger of the Company with or into another corporation (other
than a consolidation or merger in which the Company is the continuing
corporation and that does not result in any reclassification or change of Common
Stock outstanding) or in the case of any sale or conveyance to another
corporation of the property of the Company as an entirety or substantially as
an entirety.
Such giving of notice shall be initiated (i) at least 10 Business Days prior to
the date fixed as a record date or effective date or the date of closing of the
Company's stock transfer books for the determination of the shareholders
entitled to such dividend, distribution or subscription rights, or for the
determination of the shareholders entitled to vote on such proposed merger,
consolidation, sale, conveyance, dissolution, liquidation or winding up. Such
notice shall specify such record date or the date of closing the stock transfer
books, as the case may be. Failure to provide such notice shall not affect the
validity of any action taken in connection with such dividend, distribution or
subscription rights, or proposed merger,
<PAGE> 10
consolidation, sale, conveyance, dissolution, liquidation or winding up.
Section 4.02: Lost, Stolen, Mutilated or Destroyed Warrants. If this
Warrant is lost, stolen, mutilated or destroyed, the Company may, on such terms
as to indemnity or otherwise as it may in its discretion impose (which shall,
in the case of a mutilated Warrant, include the surrender thereof), issue a new
Warrant of like denomination and tenor as and in substitution for this Warrant.
ARTICLE V
Split-Up, Combination
Exchange and Transfer of Warrants
Section 5.01: Split-Up, Combination, Exchange and Transfer of Warrants.
Subject to the provisions of Section 5.02 hereof, this Warrant may be split up,
combined or exchanged for another Warrant or Warrants containing the same terms
to purchase a like aggregate number of Warrant Shares. If the Warrantholder
desires to split up, combine or exchange Warrants, he or it shall make such
request in writing delivered to the Company and shall surrender to the Company
any Warrants to be so split up, combined or exchanged. Upon any such surrender
for a split up, combination or exchange, the Company shall execute and deliver
to the person entitled thereto a Warrant or Warrants, as the case may be, as so
requested. The Company shall not be required to effect any split up,
combination or exchange which will result in the issuance of a Warrant
entitling the Warrantholder to purchase upon exercise a fraction of a share of
Common Stock or a fractional Warrant. The Company may require such
Warrantholder to pay a sum sufficient to cover any tax or governmental charge
that may be imposed in connection with any split up, combination or exchange of
Warrants.
Section 5.02: Restrictions on Transfer. Neither this Warrant nor the
Warrant Shares may be disposed of or encumbered (any such action, a
"Transfer"), except (i) to Oppenheimer & Co., Inc., any successor to the
business of such company, or any officer of such company, or (ii) to any
underwriter in connection with a Public Offering of the Common Stock provided
(as to (ii)) that this Warrant is exercised upon such Transfer and the shares
of Common Stock issued upon such exercise are sold by such underwriter as part
of such Public Offering and, as to both (i) and (ii), only in accordance with
and subject to the provisions of the Securities Act and the rules and
regulations promulgated thereunder. If at the time of a Transfer, a
Registration Statement is not in effect to register this Warrant or the Warrant
Shares, the Company may require the Warrantholder to make such representations,
and may place such legends on certificates representing this Warrant, as may be
reasonable required in the opinion of counsel to the Company to permit a
Transfer without such registration.
ARTICLE VI
Registration Under the Securities Act of 1933
Section 6.01: Piggyback Registration
(a) Right to Include Registrable Securities. If at any time
or from time to time after
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_____________ and prior to the Expiration Date, the Company proposes to
register any of its securities under the Securities Act on any form for the
registration of securities under such Act, whether or not for its own account
(other than by a registration statement on Form S-8 or other form which does
not include substantially the same information as would be required in a form
for the general registration of securities or would be available for the
Registrable Securities) (a "Piggyback Registration"), it shall as
expeditiously as possible give written notice to all Holders of its intention
to do so and of such Holders' rights under this Section 6.01. Such rights are
referred to hereinafter as "Piggyback Registration Rights." Upon the written
request of any such Holder made within 20 days after receipt of any such
notice (which request shall specify the Registrable Securities intended to be
disposed of by such Holder), the Company shall include in the Registration
Statement the Registrable Securities which the Company has been so requested to
register by the Holders thereof and the Company shall keep such registration
statement in effect and maintain compliance with each Federal and state law or
regulation for the period necessary for such Holder to effect the proposed sale
or other disposition (but in no event for a period greater than 120 days).
(b) Withdrawal of Piggyback Registration by Company. If,
at any time after giving written notice of its intention to register any
securities in a Piggyback Registration but prior to the effective date of
the related Registration Statement, the Company shall determine for any reason
not to register such securities, the Company shall give written notice of such
determination to each Holder and, thereupon, shall be relieved of its
obligation to register any Registrable Securities in connection with such
Piggyback Registration. All best efforts obligations of the Company pursuant to
Section 6.04 shall cease if the Company determines to terminate prior to such
effective date any registration where Registrable Securities are being
registered pursuant to this Section 6.01.
(c) Piggyback Registration of Underwritten Public
Offerings. If a Piggyback Registration involves an offering by or through
underwriters, then, (i) all Holders requesting to have their Registrable
Securities included in the Company's Registration Statement must sell their
Registrable Securities to the underwriters selected by the Company on the same
terms and conditions as apply to other selling shareholders and (ii) any Holder
requesting to have his or its Registrable Securities included in such
Registration Statement may elect in writing, not later than three Business Days
prior to the effectiveness of the Registration Statement filed in connection
with such registration, not to have his or its Registrable Securities so
included in connection with such registration.
(d) Payment of Registration Expenses for Piggyback
Registration. The Company shall pay all Registration Expenses in connection
with each registration of Registrable Securities requested pursuant to a
Piggyback Registration Right contained in this Section 6.01.
(e) Priority in Piggyback Registration. If a Piggyback
Registration involves an offering by or through underwriters, the Company shall
not be required to include Registrable Shares therein if and to the extent the
underwriter managing the offering reasonably believes in good faith and advises
each Holder requesting to have Registrable Securities included in the Company's
Registration Statement that such inclusion would materially adversely affect
such offering; provided that (i) if other selling shareholders who are
employees, officers, directors or other affiliates of the Company have
requested registration of securities in the proposed offering, the Company will
reduce or eliminate such other selling shareholders' securities before any
reduction or elimination of Registrable Securities; (ii) any such reduction of
elimination (after taking into account the effect of clause (i) shall be pro
rata to all other
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<PAGE> 12
holders of the securities of the Company exercising "piggyback registration
rights" similar to those set forth herein in proportion to the respective
number of shares they have requested to be registered, and (iii) in such event,
such Holders may delay any offering by them of all Registrable Shares requested
to be included (or that portion of such Registrable Shares eliminated for such
period, not to exceed 60 days, as the managing underwriter shall request) and
the Company shall file such supplements and post-effective amendments and take
such other action necessary under Federal and state law or regulation as may be
necessary to permit such Holders to make their proposed offering for a period
of 90 days following such period of delay.
Section 6.02: Demand Registration
(a) Request for Registration. If, at any time subsequent to
_______________ and prior to the Expiration Date, any 25% Holders request
that the Company file a registration statement under the Securities Act, the
Company as soon as practicable shall use its best efforts to file a
registration statement with respect to all Warrant Shares that it has been so
requested to include and to obtain the effectiveness thereof, and to take all
other action necessary under any Federal or state law or regulation to permit
the Warrant Shares that are then held and/or that may be acquired upon the
exercise of the Warrants specified in the notices of the Holders or holders
thereof to be sold or otherwise disposed of, and the Company shall maintain
such compliance with each such Federal and state law and regulation for the
period necessary for such Holders or holders to effect the proposed sale or
other disposition (but in no event for more than 120 days); provided, however,
the Company shall be entitled to defer such registration for a period of up to
60 days if and to the extent that its Board of Directors shall determine that
such registration would interfere with a pending corporate transaction. The
Company shall also promptly give written notice to the Holder and the holders
of any other Warrants and/or the holders of any Warrant Shares who or that have
not made a request to the Company pursuant to the provisions of this subsection
(a) of its intention to effect any required registration or qualification and
shall use its best efforts to effect as expeditiously as possible such
registration or qualification of all other such Warrant Shares that are then
held and/or that may be acquired upon the exercise of the Warrants, the Holder
or holders of which have requested such registration or qualification, within
15 days after such notice has been given by the Company, as provided in the
preceding sentence. The Company shall be required to effect a registration or
qualification pursuant to this subsection (a) on one occasion only.
(b) Payment of Registration Expenses for Demand Registration. The
Company shall pay all Registration Expenses in connection with the Demand
Registration.
(c) Selection of Underwriters. If any Demand Registration is
requested to be in the form of an underwritten offering, the managing
underwriter shall be Oppenheimer & Co., Inc. and the co-manager (if any) and
the independent pricer required under the rules of the NASD (if any) shall be
selected and obtained by the Holders of a majority of the Warrant Shares to be
registered. Such selection shall be subject to the Company's consent, which
consent shall not be unreasonably withheld. All fees and expenses (other than
Registration Expenses otherwise required to be paid) of any managing
underwriter, any co-manager or any independent underwriter or other independent
pricer required under the rules of the NASD shall be paid for by such
underwriters or by the Holders or holders whose shares are being registered. If
Oppenheimer & Co., Inc. should decline to serve as managing underwriter, the
Holders of a majority of the Warrant Shares to be registered may select and
obtain one or more managing underwriters. Such selection shall be subject to
the Company's consent, which consent shall not be unreasonably withheld.
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<PAGE> 13
Section 6.03: Buy-outs of Registration Demand. In lieu of carrying
out its obligations to effect a Piggyback Registration or Demand Registration
of any Registrable Securities pursuant to this Article VI, the Company may
carry out such obligation by offering to purchase and purchasing such
Registrable Securities requested to be registered at an amount in cash equal to
the difference between (a) the last sale price of the Common Stock on the day
the request for registration is made and (b) the Exercise Price in effect on
such day.
Section 6.04: Registration Procedures. If and whenever the Company is
required to use its best efforts to take action pursuant to any Federal or
state law or regulation to permit the sale or other disposition of any Warrant
Shares that are then held or that may be acquired upon exercise of the
Warrants, in order to effect or cause the registration of any Registrable
Securities under the Securities Act as provided in this Article VI, the Company
shall, as expeditiously as practicable:
(a) furnish to each selling Holder of Registrable Securities and the
underwriters, if any, without charge, as many copies of the Registration
Statement, the Prospectus or the Prospectuses (including each preliminary
prospectus) and any amendment or supplement thereto as they may reasonably
request;
(b) enter into such agreements (including an underwriting agreement)
and take all such other actions reasonably required in connection therewith in
order to expedite or facilitate the disposition of such Registrable Securities
and in such connection, if the registration is in connection with an
underwritten offering (i) make such representations and warranties to the
underwriters in such form, substance and scope as are customarily made by
issuers to underwriters in underwritten offerings and confirm the same if and
when requested; (ii) obtain opinions of counsel to the Company and updates
thereof (which counsel and opinions in form, scope and substance shall be
reasonably satisfactory to the underwriters) addressed to the underwriters and
the Holders covering the matters customarily covered in opinions requested in
underwritten offerings and such other matters as may be reasonably requested by
such underwriters; (iii) obtain "cold comfort" letters and updates thereof from
the Company's accountants addressed to the underwriters such letters to be in
customary form and to cover matters of the type customarily covered in "cold
comfort" letters to underwriters and the Holders in connection with
underwritten offerings; (iv) set forth in full, in any underwriting agreement
entered into, the indemnification provisions and procedures of Section 6.05
hereof with respect to all parties to be indemnified pursuant to said Section;
and (v) deliver such documents and certificates as may be reasonably requested
by the underwriters to evidence compliance with clause (i) above and with any
customary conditions contained in the underwriting agreement or other agreement
entered into by the Company; the above shall be done at each closing under such
underwriting or similar agreement or as and to the extent required thereunder;
(c) make available for inspection by one or more representatives of
the Holders of Registrable Securities being sold, any underwriter participating
in any disposition pursuant to such registration, and any attorney or
accountant retained by such Holders or underwriter, all financial and other
records, pertinent corporate documents and properties of the company, and cause
the company's officers, directors and employees to supply all information
reasonably requested by any such representatives in connection with such;
(d) otherwise use its best efforts to comply with all applicable
Federal and state
<PAGE> 14
regulations; and take such other action as may be reasonably necessary or
advisable to enable each such Holder and each such underwriter to consummate
the sale or disposition in such jurisdiction or jurisdiction, in which any such
Holder or underwriter shall have requested that the Registrable Securities be
sold.
Except as otherwise provided in this Agreement, the Company shall have sole
control in connection with the preparation, filing, withdrawal, amendment or
supplementing of each Registration Statement, the selection of underwriters, and
the distribution of any preliminary prospectus included in the Registration
Statement, and may include within the coverage thereof additional shares of
Common Stock or other securities for its own account or for the account of one
or more of its other security holders;
Each seller of Registrable Securities as to which any
registration is being effected shall furnish to the Company such information
regarding the distribution of such securities and such other information as may
otherwise be required by the Securities Act to be included in such Registration
Statement.
Section 6.05: Indemnification.
(a) Indemnification by Company. In connection with each
Registration Statement relating to disposition of Registrable Securities, the
Company shall indemnify and hold harmless each Holder and each underwriter of
Registrable Securities and each Person, if any, who controls such Holder or
underwriter (within the meaning of Section 15 of the Securities Act or Section
20 of the Exchange Act) against any and all losses, claims, damages and
liabilities, joint or several (including any reasonable investigation, legal
and other expenses incurred in connection with, and any amount paid in
settlement of any action, suit or proceeding or any claim asserted), to which
they, or any of them, may become subject under the Securities Act, the Exchange
Act or other Federal or state law or regulation, at common law or otherwise,
insofar as such losses, claims, damages or liabilities arise out of or are
based upon any untrue statement or alleged untrue statement of a material fact
contained in any Registration Statement, Prospectus or preliminary prospectus
or any amendment thereof or supplement thereto, or arise out of or are based
upon any omission or alleged omission to state therein a material fact required
to be stated therein or necessary to make the statements therein not
misleading; provided, however, that such indemnity shall not inure to the
benefit of any Holder or underwriter (or any Person controlling such Holder or
underwriter within the meaning of Section 15 of the Securities Act or Section
20 of the Exchange Act) on account of any losses, claims, damages or
liabilities arising from the sale of Registrable Securities if such untrue
statement or omission or alleged untrue statement or omission was made in such
Registration Statement, Prospectus or preliminary prospectus, or such amendment
or supplement, in reliance upon and in conformity with information furnished in
writing to the company by the Holder or underwriter specifically for use
therein. The Company shall also indemnify selling brokers, dealer managers and
similar securities industry professionals participating in the distribution,
their officers and directors and each Person who industry professionals
participating in the distribution, their officers and directors and each Person
who controls such Persons (within the meaning of Section 15 of the Securities
Act or Section 20 of the Exchange Act) to the same extent as provided above
with respect to the Indemnification of the Holders of Registrable Securities,
if requested. This indemnity agreement shall be in addition to any liability
which the Company may otherwise have.
(b) Indemnification by Holder. In connection with each
Registration Statement, each Holder shall indemnify, to the same extent as the
indemnification provided by the Company in Section 6.05(a), the Company, its
directors and each officer who signs the Registration Statement and each Person
who controls the Company (within the meaning of Section 15 of the Securities
Act and Section 20 of the Exchange Act) but only insofar as such losses,
claims, damages and liabilities arise out of or are based upon any untrue
statement or omission or alleged untrue statement or omission which was made in
the Registration Statement, the Prospectus or preliminary prospectus or any
amendment thereof or supplement thereto, in reliance upon and in conformity
with information furnished in writing by such Holder to the Company
specifically for use therein. In no event shall the liability of any selling
Holder of Registrable
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Securities hereunder be greater in amount than the dollar amount of the net
proceeds received by such Holder upon the sale of the Registrable Securities
giving rise to such indemnification obligation. The Company shall be entitled
to receive indemnities from underwriters, selling brokers, dealer managers and
similar securities industry professionals participating in the distribution, to
the same extent as provided above, with respect to information so furnished in
writing by such Persons specifically for inclusion in any Prospectus,
Registration Statement or preliminary prospectus or any amendment thereof or
supplement thereto.
(c) Conduct of Indemnification Procedure. Any party that
proposes to assert the right to be indemnified hereunder will, promptly after
receipt of notice of commencement of any action, suit or proceeding against
such party in respect of which a claim is to be made against an indemnifying
party or parties under this Section, notify each such indemnifying party of
the commencement of such action, suit or proceeding, enclosing a copy of all
papers served. No indemnification provided for in Section 6.05(a) or 6.05(b)
shall be available to any party who shall fail to give notice as provided in
this Section 6.05(c) if the party to whom notice was not given was unaware of
the proceeding to which such notice would have related and was prejudiced by
the failure to give such notice, but the omission so to notify such
indemnifying party of any such action, suit or proceeding shall not relieve it
from any liability that it may have to any indemnified party for contribution or
otherwise than under this Section. In case any such action, suit or proceeding
shall be brought against any indemnified party and it shall notify the
indemnifying party of the commencement thereof, the indemnifying party shall
be entitled to participate in, and, to the extent that it shall wish, jointly
with any other indemnifying party similarly notified, to assume the defense
thereof, with counsel satisfactory to such indemnified party, and after notice
from the indemnifying party to such indemnified party of its election so to
assume the defense thereof and the approval by the indemnifying party to such
indemnified party of its election so to assume the defense thereof and the
approval by the indemnified party of such counsel, the indemnifying party shall
not be liable to such indemnified party for any legal or other expenses,
except as provided below and except for the reasonable costs of investigation
subsequently incurred by such indemnified party in connection with the defense
thereof. The indemnified party shall have the right to employ its counsel in
any such action, but the fees and expenses of such counsel shall be at the
expense of such indemnified party unless (i) the employment of counsel by such
indemnified party has been authorized in writing by the indemnifying parties,
(ii) the indemnified party shall have reasonably concluded that there may be a
conflict of interest between the indemnifying parties and the indemnified
party in the conduct of the defense of such action (in which case the
indemnifying parties shall not have the right to direct the defense of such
action on behalf of the indemnified party) or (iii) the indemnifying parties
shall not have employed counsel to assume the defense of such action within a
reasonable time after notice of the commencement thereof, in each of which
cases the fees and expenses of counsel shall be at the expense of the
indemnifying parties. An indemnifying party shall not be liable for any
settlement of any action, suit, proceeding or claim effected without its written
consent.
(d) Contribution. In connection with each Registration
Statement relating to the disposition of Registrable Securities, if the
indemnification provided for in subsection (a) hereof is unavailable to an
indemnified party thereunder in respect of any losses, claims, damages or
liabilities referred to therein, then the Company shall, in lieu of
indemnifying such indemnified party, contribute to the amount paid or payable by
such indemnified party as a result of such losses, claims, damages or
liabilities. The amount to be contributed by the Company hereunder shall be an
amount which is in the same proportionate relationship to the total amount of
such losses, claims, damages or liabilities as the total net proceeds from the
offering (before deducting expenses) of the Registrable Securities bears to the
total price to the public (including underwriters' discounts) for the offering
of the Registrable Securities covered by such registration.
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(e) Specific Performance. The Company and the Holder
acknowledge that remedies at law for the enforcement of this Section 6.05 may
be inadequate and intend that this Section 6.05 shall be specifically
enforceable.
ARTICLE VII
Other Matters
Section 7.01: Amendments and Waivers. The provisions of this Warrant,
including the provisions of this sentence, may not be amended, modified or
supplemented, and waiver or consents to departures from the provisions hereof
may not be given unless the Company has obtained the written consent of holders
of at least a majority of the outstanding Registrable Securities. Holders shall
be bound by any consent authorized by this Section whether or not certificates
representing such Registrable Securities have been marked to indicate such
consent.
Section 7.02: Counterparts. This Warrant may be executed in any number
of counterparts and by the parties hereto in separate counterparts, each of
which so executed shall be deemed to be an original and all of which taken
together shall constitute one and the same agreement.
Section 7.03: Governing Law. This Warrant shall be governed by and
construed in accordance with the laws of the State of New York.
Section 7.04: Severability. In the event that any one or more of the
provisions contained herein, or the application thereof in any circumstances,
is held invalid, illegal or unenforceable, the validity, legality and
enforceability of any such provisions in every other respect and of the
remaining provisions contained herein shall not be affected or impaired thereby.
Section 7.05: Attorneys' Fees. In any action or proceeding brought to
enforce any provisions of this Warrant, or where any provisions hereof or
thereof is validly asserted as a defense, the successful party shall be entitled
to recover reasonable attorneys' fees and disbursements in addition to its
costs and expenses and any other available remedy.
Section 7.06: Computations of Consent. Whenever the consent or approval
of Holders of a specified percentage of Registrable Securities is required
hereunder, Registrable Securities held by the Company or its affiliates (other
than the Warrantholder or subsequent Holders is they are deemed to be such
affiliates solely by reason of their holdings of such Registrable Securities)
shall not be counted in determinant whether such consent or approval was given
by the Holders of such required percentage.
Section 7.07: Notice. Any notices or certificates by the Company to the
Holder and by the Holder to the Company shall be deemed delivered if in writing
and delivered in person or by registered mail (return receipt requested) to the
Holder addressed to him in care of Oppenheimer & Co., Inc., Oppenheimer Tower,
World Financial Center, New York, New York 10281 or, if the Holder has
designated, by notice in writing to the Company, any other address, to such
other address, and if to the Company, addressed to it at ___________________,
_____________________, ____________________. The Company may change its address
by written notice to the Holder and the Holder may change his or its address by
written notice to the Company.
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<PAGE> 17
IN WITNESS WHEREOF, this Warrant has been duly executed by the Company
under its corporate seal as of the ______ day of , 1997.
Cellegy Pharmaceuticals, Inc.
By:______________________________
Name:
Title:
Attest:_____________________
Secretary
17
<PAGE> 18
ASSIGNMENT
(To be executed only upon assignment of Warrant Certificate)
For value received, _______________ hereby sells, assigns and
transfers unto ____________________________ the within Warrant Certificate,
together with all right, title and interest therein, and does hereby
irrevocably constitute and appoint _______________________ attorney, to
transfer said Warrant Certificate on the books of the within-named Company with
respect to the number of Warrants set forth below, with full power of
subscription in the premises:
Name(s) of
Assignees(s) Address No. of Warrants
------------ ------- ---------------
And if said number of Warrants shall not be all the Warrants represented by the
Warrant Certificate, a new Warrant Certificate is to be issued in the name of
said undersigned for the balance remaining of the Warrants represented by said
Warrant Certificate
Dated:_____________ , 19__
___________________________________
Note: The above signature should
correspond exactly with the name on the
face of this Warrant Certificate.
18
<PAGE> 19
SUBSCRIPTION FORM
(TO BE EXECUTED UPON EXERCISE OF WARRANT
PURSUANT TO SECTION 2.02(a)(i))
The undersigned hereby irrevocably elects to exercise the right of
purchase represented by the within Warrant Certificate for, and to purchase
thereunder shares of Common Stock, as provided for therein, and tenders
herewith payment of the purchase price in full in the form of cash or a
certified or official bank check in the amount of $ .
Please issue a certificate or certificates for such Common Stock in
the name of:
Name (Please Print Name, Address
-------------------- and Social Security Number)
Signature
-------------------------------------------
NOTE: The above signature should respond exactly with the name on the first
page of this Warrant Certificate or with the name of the assignee
appearing in the assignment form below.
And if said number of shares shall not be all the shares purchasable
under the within Warrant Certificate, a new Warrant Certificate is to be issued
in the name of said undersigned for the balance remaining of the shares
purchasable thereunder rounded up to the next higher number of shares.
19
<PAGE> 20
CASHLESS EXERCISE FORM
(TO BE EXECUTED UPON EXERCISE OF WARRANT)
PURSUANT TO SECTION 2.02(a)(ii))
The undersigned hereby irrevocably elects to Exchange its Warrant for
such shares of Common Stock pursuant to the Cashless Exercise provisions of the
within Warrant Certificate, as provided for in Section 2.02(a)(ii) of such
Warrant Certificate.
Please issue a certificate or certificates for such Common Stock in the
name of:
Name _____________ Please Print Name,
address and Social Security Number)
Signature _________________________
NOTE: The above signature should correspond exactly with the name on the first
page of this Warrant Certificate or with the name of the assignee appearing in
the assignment form below.
And if said number of shares shall not be all the shares exchangeable
or purchasable under the within Warrant Certificate, a new Warrant Certificate
is to be issued in the name of the undersigned for the balance remaining of the
shares purchasable rounded up to the next higher number of shares.
20
<PAGE> 1
EXHIBIT 5.1
October 17, 1997
Cellegy Pharmaceuticals, Inc.
1065 E. Hillsdale Blvd.
Suite 418
Foster City, CA 94404
Gentlemen/Ladies:
At your request, we have examined the Registration Statement on Form S-1
(the "Registration Statement") to be filed by you with the Securities and
Exchange Commission (the "Commission") on or about October 17, 1997,in
connection with the registration under the Securities Act of 1933, as amended,
of an aggregate of 2,587,500 shares of your Common Stock (the "Stock"), all of
which will be sold by the Company.
In rendering this opinion, we have examined the following:
(1) the Registration Statement, together with the Exhibits filed as a
part thereof;
(2) your registration statement on Form 8-A filed with the Commission
in connection with the Company's initial public offering in August 1995;
(3) the Prospectus prepared in connection with the Registration
Statement;
(4) the minutes of meetings and actions by written consent of the
Board of Directors that are contained in your minute books and that are in
our possession, that relate to issuance of the Stock;
(5) the articles of incorporation of the Company as amended through
the date of this opinion and the Bylaws of the Company, both certified by
the Secretary of the Company on October 17, 1997; and
(6) a Management Certificate addressed to us and dated of even date
herewith executed by the Company containing certain factual and other
representations.
In our examination of documents for purposes of this opinion, we have
assumed, and express no opinion as to, the genuineness of all signatures on
original documents, the authenticity of all documents submitted to us as
originals, the conformity to originals of all documents submitted to us as
copies, the legal capacity of all natural persons executing the same, the lack
of any undisclosed terminations, modifications, waivers or amendments to any
documents reviewed by us and the due execution and delivery of all documents
where due execution and delivery are prerequisites to the effectiveness thereof.
As to matters of fact relevant to this opinion, we have relied solely upon
our examination of the documents referred to above and have assumed the current
accuracy and completeness of the information obtained from records included in
the documents referred to above. We have made no independent investigation or
other attempt to verify the accuracy of any of such information or to determine
the existence or non-existence of any other factual matters; however, we are not
aware of any facts that would lead us to believe that the opinion expressed
herein is not accurate.
In rendering any opinion that the shares of Stock are, or will when issued
be, "fully paid," we have assumed that such shares will be issued in accordance
with the terms of the underwriting agreement attached as an exhibit to the
Registration Statement, and that the Company will receive full consideration for
the issuance of such shares provided for in such agreement.
Based upon the foregoing, it is our opinion that the shares of Stock to be
sold by the Company pursuant to the Registration Statement are legally issued
and nonassessable and, to our knowledge, fully paid.
We consent to the use of this opinion as an exhibit to the Registration
Statement and further consent to all references to us, if any, in the
Registration Statement, the Prospectus constituting a part thereof and any
amendments thereto.
This opinion speaks only as of its date and is intended solely for your use
as an exhibit to the Registration Statement for the purpose of the above sale of
the Stock and is not to be relied upon for any other purpose.
Very truly yours,
FENWICK & WEST LLP
By: /s/ Fenwick & West LLP
<PAGE> 1
EXHIBIT 10.3
[UNIVERSITY OF CALIFORNIA LETTERHEAD]
May 14, 1997
IN DUPLICATE
Michael L. Francoeur, Ph.D.
Vice President, Research and Development
Cellegy Pharmaceuticals, Inc.
1065 E. Hillsdale Boulevard, Suite 418
Foster City, CA 94404
RE: Amendment to Exclusive License Agreement (UC Control No. 94-04-0139)
UC Case Nos. 93-252 and 93-253
Dear Dr. Francoeur:
Per our recent discussions and meetings regarding Cellegy's progress in the
development of Licensed Products under the above-referenced Exclusive License
Agreement ("Agreement"), The Regents of the University of California agrees to
amend the subject Agreement to revise and extend the due diligence milestones
recited in Paragraph 6.4. Thus, Paragraph 6.4 of the above-referenced Agreement
is hereby deleted and replaced with the following:
"6.4 The Licensee shall:
6.4a complete proof-of-concept studies in an animal
species, other than rodents, that demonstrate the feasibility of the
technology for use in the transdermal delivery of a pharmaceutical drug by
December 31, 1997; and
6.4b enter into a corporate partnership for the development
or marketing of a Licensed Product in the over-the-counter ("OTC") or
prescription markets by December 31, 1998; and
6.4c enter into a second corporate partnership for the
development or marketing of a Licensed Product in the OTC or prescription
markets by December 31, 1999; and
6.4d complete Phase I/II trials in humans for a Licensed
Product by June 30, 2000; and
<PAGE> 2
Dr. Michael Francoeur
May 14, 1997
Page 2
6.4e submit an application for regulatory approval for a Licensed
Product that is intended for sale only pursuant to a physicians prescription or
pharmacist's approval or similar limitation in the sale or use of such product
to the United States Food and Drug Administration (FDA), or the equivalent
foreign regulatory authority in any two of Germany, France or the United
Kingdom by June 30, 2002; and
6.4f obtain regulatory approval for a Licensed Product that is
intended for sale only pursuant to a physicians prescription or pharmacist's
approval or similar limitation in the sale or use of such product from the
United States Food and Drug Administration (FDA), or the equivalent foreign
regulatory authority in any two of Germany, France or the United Kingdom by
January 1, 2005; and
6.4g commence commercial marketing of a Licensed Product within
twelve (12) months of receiving approval of such Licensed Product in any
country; and
6.4h reasonably fill the market demand for the Licensed Product in
each country following commencement of marketing in such country at all times
during the term of this Agreement."
Paragraphs 6.5 and 6.6 are hereby added to the Agreement as follows:
"6.5 If the Licensee is unable to perform any of the provisions of
Paragraph 6.4, then The Regents has the right, subject to Paragraph 6.6, to
terminate this Agreement upon sixty (60) days' written notice. Should the
licensee fail to fulfill the diligence requirements within said sixty-day
period, the notice shall be effective at the end of said period. This right, if
exercised by The Regents, supersedes the rights granted in Article 2 (Grant)
and is subject to Paragraph 6.6.
6.6 If the Licensee is unable to meet any of the dates set forth in
Paragraph 6.4, Licensee shall be entitled to a one-time extension of each of the
dates (which have not been met) by one (1) additional year upon payment of [*]
to The Regents, provided that such payment is received by The Regents within
sixty (60) days of receipt of written notice by The Regents that the Licensee
has not met a due diligence date. The [*] payment has the effect of extending
the subject date and all subsequent dates by one (1) year. The Regents shall not
exercise its right to terminate this Agreement unless a re-established date is
not met."
- ------------
*Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
<PAGE> 3
Dr. Michael Francoeur
May 14, 1997
Page 3
The remaining provisions of the Agreement remain in full force and effect.
If this Amendment is acceptable to you, please sign this letter and the
duplicate original in the spaces provided and return both to this office. I will
then have both originals executed on behalf of The Regents and return one
fully-executed original to you. This Amendment will be effective upon execution
of this letter by both parties.
Sincerely,
/s/ Patricia Anderson Cotton, Ph.D.
-----------------------------------
Patricia Anderson Cotton, Ph.D.
Licensing Officer
________________________________________________________________________________
AGREED:
CELLEGY PHARMACEUTICALS THE REGENTS OF THE
INC. UNIVERSITY OF CALIFORNIA
By: /s/ Michael Francouer By:
-------------------------------- -------------------------------
(signature)
Name: /s/ Michael Francouer Name: Terence A. Feuerborn
------------------------------
(please print)
Title: VP R&D Title: Executive Director
----------------------------- Research Administration and
Technology Transfer
Date: August 1, 1997 Date:
------------------------------ -----------------------------
Approved as to legal form Sandy Schultz 5/13/97
------------- -------
Sandy S. Schultz, Attorney
Office of Technology Transfer
University of California
<PAGE> 1
[UNIVERSITY OF CALIFORNIA LETTERHEAD]
EXHIBIT 10.4
October 6, 1997
IN DUPLICATE
Michael L. Francoeur, Ph.D.
Vice President, Research and Development
Cellegy Pharmaceuticals, Inc.
1065 E. Hillsdale Boulevard, Suite 418
Foster City, CA 94404
RE: Amendment to Exclusive License Agreement (UC Control No. 93-04-0784)
UC Case Nos. 91-261 and 92-231
Dear Dr. Francoeur:
As we recently discussed, Cellegy sublicensed its rights under the
above-referenced Exclusive License Agreement ("Agreement") to Neutrogena
Corporation. Neutrogena was subsequently acquired by Johnson and Johnson.
Neither Neutrogena nor Johnson and Johnson diligently pursued the development
of a Licensed Product as required under the Agreement entered into between
Cellegy Pharmaceuticals, Inc. and The Regents of the University of California.
In as much as Cellegy is nearing completion of its negotiations with
Neutrogena/Johnson and Johnson and plans to regain control over the
technology, The Regents of the University of California agrees to amend the
Agreement to revise and extend the due diligence milestones recited in
Paragraph 6.4. Thus, Paragraph 6.4 of the above-referenced Agreement is hereby
deleted and replaced with the following:
"6.4 The Licensee shall:
6.4a On or before October 31, 1997, either terminate its
current agreement with Neutrogena/Johnson and Johnson to obtain for Licensee
exclusive control over the technology (in which case the diligence terms of
6.4b-6.4k will apply) or execute an agreement with Neutrogena/Johnson and
Johnson which recites diligence terms reasonably acceptable to The Regents for
the development of the technology; and
6.4b select a clinical candidate for evaluation in human
clinical trials by December 31, 1997; and
<PAGE> 2
Dr. Michael Francoeur
October 6, 1997
Page 2
6.4c complete proof-of-concept studies for the clinical candidate
selected in 6.4b by June 30, 1998; and
6.4d if Licensee elects not to market a non-prescription product,
enter into a corporate partnership for the marketing of a non-prescription
Licensed Product in either the cosmetic or over-the-counter drug markets by
December 31, 1998; and
6.4e commence commercial marketing of a non-prescription Licensed
Product in either the cosmetic or over-the-counter drug markets by December 31,
1999; and
6.4f submit an IND for a Licensed Product to the United States Food
and Drug Administration or the equivalent foreign regulatory authority in any
three of Japan, Germany, France or the United Kingdom by December 31, 2000;
and
6.4g complete a phase I/II and/or efficacy clinical trial for Licensed
Product by December 31, 2001; and
6.4h file for marketing approval for a Licensed Product that is
intended for sale only pursuant to a physicians prescription or pharmacist's
approval or similar limitation in the sale or use of such product to the United
States Food and Drug Administration (FDA), or the equivalent foreign regulatory
authority in any three of Japan, Germany, France or the United Kingdom by
August 30, 2002; and
6.4i obtain regulatory approval for a Licensed Product that is
intended for sale only pursuant to a physician's prescription or pharmacist's
approval or similar limitation in the sale or use of such product from the
United States Food and Drug Administration (FDA), or the equivalent foreign
regulatory authority in any three of Japan, Germany, France or the United
Kingdom by August 30, 2004; and
6.4j commence commercial marketing of a Licensed Product within twelve
(12) months of receiving approval of such Licensed Product in any country; and
6.4k reasonably fill the market demand for a Licensed Product in each
country following commencement of marketing in such country at all times during
the term of this Agreement."
<PAGE> 3
Dr. Michael Francoeur
October 6, 1997
Page 3
Paragraphs 6.5 and 6.6 are hereby added to the Agreement as follows:
"6.5 If the Licensee is unable to perform any of the provisions of
Paragraph 6.4, then The Regents has the right, subject to Paragraph 6.6, to
terminate this Agreement upon sixty (60) days' written notice. Should the
licensee fail to fulfill the diligence requirements within said sixty-day
period, the notice shall be effective at the end of said period. If such
termination is based on failure of diligence as to prescription use, such
termination shall be effective only as to such use. This right, if exercised by
The Regents, supersedes the rights granted in Article 2 (Grant) and is subject
to Paragraph 6.6.
6.6 If the Licensee is unable to meet any of the dates set forth in
Paragraphs 6.4f through 6.4k, Licensee shall be entitled to a one-time extension
of each of the dates (which have not been met) by one (1) additional year upon
payment of [*] to The Regents, provided that such payments is received by The
Regents within sixty (60) days of receipt of written notice by The Regents that
the Licensee has not met a due diligence date. The [*] payment has the effect of
extending the subject date and all subsequent dates by one (1) year. The Regents
shall not exercise its rights to terminate this Agreement unless a
re-established date is not met."
In addition, the parties wish to amend the Agreement to provide for the payment
of a license maintenance fee to The Regents. Accordingly, the following
Paragraph 5.9 is added to Article 5 (Royalties) of the Agreement.
"5.9 The Licensee shall pay to The Regents a royalty in the form of a
license maintenance fee of [*] beginning January 1, 1999, and continuing
annually on January 1 of each subsequent year. The license maintenance fee
shall not be due and payable on any January 1 if on said date the Licensee is
commercially selling a Licensed Product and paying an earned royalty to The
Regents on the sales of that Licensed Product. For the first year of commercial
sales, the Licensee's obligation to pay the license maintenance fee will be
pro-rated for the number of full months in the year up until the commencement of
commercial sales. License maintenance fees are non-refundable and not an advance
against earned royalties."
- ------------
*Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the
omitted portions.
<PAGE> 4
Dr. Michael Francoeur
October 6, 1997
Page 4
All other provisions of the Agreement remain in full force and effect.
If this Amendment is acceptable to you, please sign this letter and the
duplicate original in the spaces provided and return both to this office. I
will then have both originals executed on behalf of The Regents and return one
fully-executed original to you. This Amendment will be effective upon execution
of this letter by both parties.
Sincerely,
/s/PATRICIA ANDERSON COTTON, PH.D.
---------------------------------------
Patricia Anderson Cotton, Ph.D.
Licensing Officer
- -------------------------------------------------------------------------------
AGREED:
CELLEGY PHARMACEUTICALS THE REGENTS OF THE
INC. UNIVERSITY OF CALIFORNIA
By: /s/ K. Michael Forrest By:
---------------------------------- ---------------------------------------
(Signature)
Name: /s/ K. Michael Forrest Name: Terence A. Feuerborn
--------------------------------
(please print)
Title: President & CEO Title: Executive Director
------------------------------- Research Administration and
Technology Transfer
Date: October 10, 1997 Date:
-------------------------------- ---------------------------------
Approved as to legal form: /s/SANDY SCHULTZ 10/3/97
---------------- -------
Sandra Schultz, Notary Date
Office of Technology Transfer
University of California
<PAGE> 1
EXHIBIT 23.1
CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS
We consent to the reference to our firm under the caption "Experts" and to
the use of our report dated February 5, 1997, in the Registration Statement
(Form S-1) and related Prospectus of Cellegy Pharmaceuticals, Inc. for the
registration of 2,587,500 shares of its common Stock.
/s/ ERNST & YOUNG LLP
San Jose, California
October 17, 1997
