As filed with the Securities and Exchange Commission on June 28, 1996
Registration No. 33-6877
================================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
-------------------------------
Post Effective Amendment No. 9
to
Form S-1
on
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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UNIGENE LABORATORIES, INC.
(Exact name of Registrant as specified in its charter)
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Delaware 22-2328609
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification Number)
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110 Little Falls Road
Fairfield, New Jersey 07004
(201) 882-0860
(Address, including zip code, and telephone number, including
area code, of Registrant's principal executive offices)
-------------------------------
Warren P. Levy, President
Unigene Laboratories, Inc.
110 Little Falls Road
Fairfield, New Jersey 07004
(201) 882-0860
(Name, address, including zip code, telephone number, including
area code, of agent for service)
-------------------------------
Copy to:
Jesse Margolin, Esq.
Becker Ross Stone DeStefano & Klein
317 Madison Avenue, Suite 1410
New York, NY 10017-5372
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Approximate date of commencement of proposed sale to public:
From time to time after this Registration Statement becomes effective.
<PAGE>
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. [ ]
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, other than securities offered only in connection with
dividend or interest reinvestment plans, check the following box. [ X ]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offer. [ ]
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 on 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. [ ]
<PAGE>
Prospectus
UNIGENE LABORATORIES, INC.
7,982,177 -Shares of Common Stock
(par value $.01 per share)
The 7,982,177 shares of common stock, $.01 par value per share
("Common Stock") offered hereby are issuable upon the exercise of outstanding
Redeemable Class B Common Stock Purchase Warrants ("Class B Warrants"). The
registered holder of each Class B Warrant is entitled to purchase 1.4269 shares
of Common Stock at $3.504 per share on or prior to August 11, 1996. The exercise
price of the Class B Warrants is subject to adjustment in certain circumstances.
The Class B Warrants are subject to redemption at $.035 per warrant on thirty
days' written notice, provided the closing bid price of the Common Stock as
reported by NASDAQ (or the last sale price listed on a national securities
exchange), for thirty consecutive business days ending within fifteen days of
the notice of redemption averages in excess of $4.9056 per share. See
"Description of Securities".
Each Class B Warrant was issued upon exercise of previously outstanding
Redeemable Class A Common Stock Purchase Warrants ("Class A Warrants"). The
Class A Warrants were included in units ("Units"). Each Unit, consisting of
three shares of Common Stock and three Class A Warrants, was sold by the Company
in its initial public offering pursuant to a Prospectus dated August 12, 1987.
The registered holder of each Class A Warrant was entitled to purchase for $3.25
one share of Common Stock and to receive one Class B Warrant on or prior to
August 11, 1992. In May 1991, the Company announced that it would call for
redemption on July 3, 1991 at a redemption price of $.05 per Warrant, all of the
then outstanding Class A Warrants. A total of 5,594,069 Class A Warrants were
exercised resulting in the issuance of 5,594,069 shares of Common Stock,
5,594,069 Class B Warrants and the receipt by the Company of net proceeds of
$17,434,000. The balance of the outstanding Class A Warrants were redeemed.
In December 1994, November 1995, and June 1996 as a result of private
placements of Common Stock and issuance of warrants to purchase Common Stock at
prices below the exercise price of the Class B Warrants, issuance of convertible
debentures convertible at prices below the exercise price of the Class B
Warrants and pursuant to the requirements of the Warrant Agreement, Unigene
adjusted the exercise price of its Redeemable Class B Common Stock Purchase
Warrants from $5.00 to $3.504 per share and adjusted the number of shares of
Common Stock thereby exercisable for each Class B Warrant from 1 share of Common
Stock to 1.4269 shares of Common Stock. As a consequence of the adjustment of
the price of the Class B Warrants, the Redemption Price of the Class B Warrants
was adjusted from $0.05 per Warrant to $.035 per Warrant, the market price of
the Common Stock required to be exceeded in order for the Company to exercise
its right of redemption was adjusted from $7.00 per share to $4.9056 per share
and the number of shares issuable was adjusted from 5,594,069 to 7,982,177.
The Company's Common Stock and Class B Warrants have traded in the
over-the-counter market since August 12, 1987 and May 28, 1991, respectively.
The Common Stock is traded on the NASDAQ National Market System under the market
symbol "UGNE" and the Warrants under the symbol "UGNEZ". On June 25, 1996, the
closing price for a share of Common Stock was $3.31 and the closing price for a
Class B Warrant was $1.03 according to NASDAQ.
<PAGE>
INVESTMENT IN THE SECURITIES OFFERED HEREBY INVOLVES A HIGH
DEGREE OF RISK. SEE "RISK FACTORS" ON PAGE 3.
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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.
The date of this Prospectus is June 28, 1996.
NO DEALER, SALESMAN OR OTHER PERSON IS AUTHORIZED TO GIVE ANY INFORMATION OR TO
MAKE ANY REPRESENTATIONS NOT CONTAINED IN THIS PROSPECTUS IN CONNECTION WITH THE
OFFER MADE HEREBY, AND, IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATIONS
MUST NOT BE RELIED UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY, ANY SELLING
SHAREHOLDER OR ANY UNDERWRITER. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO
SELL OR A SOLICITATION OF AN OFFER TO BUY THE SECURITIES OFFERED HEREBY TO ANY
PERSON IN ANY STATE OR OTHER JURISDICTION IN WHICH SUCH OFFER OR SOLICITATION
WOULD BE UNLAWFUL. THE DELIVERY OF THIS PROSPECTUS AT ANY TIME DOES NOT IMPLY
THAT THE INFORMATION CONTAINED HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENT TO
ITS DATE.
<PAGE>
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the
Securities Exchange Act of 1934, as amended (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 maintained by the Commission at 450
Fifth Street, N.W., Washington, D.C. 20549; and the public reference facilities
located at the regional offices of the Commission at the following addresses:
New York Regional Office, 7 World Trade Center, Suite 1300, New York, New York
10048 and Chicago Regional Office, Citicorp Center, 500 West Madison Street,
Chicago, Illinois 60661-2511. Copies of such material also can be obtained from
the Public Reference Section of the Commission at 450 Fifth Street, N.W.,
Washington, D.C. 20549, at prescribed rates.
This Prospectus constitutes a part of a Registration Statement on Form
S-3 filed by the Company with the Commission under the Securities Act with
respect to the Common Stock being offered by this Prospectus. This Prospectus
does not contain all of the information set forth in the Registration Statement,
certain portions of which have been omitted as permitted by the rules and
regulations of the Commission. For further information, reference is made to the
Registration Statement, and to the exhibits incorporated therein by reference or
filed as a part thereof. Any statements contained herein concerning the
provisions of any such exhibits are not necessarily complete and, in each
instance, reference is made to the copy of such exhibit filed as an exhibit to
the Registration Statement or otherwise filed with the Commission. Each such
statement is qualified in its entirety by such reference.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The following documents filed by the Company with the Commission are
hereby incorporated by reference in this Prospectus:
1. The Annual Report of the Company on Form 10-K for the
year ended December 31, 1995 (the "1995 10-K").
2. The Annual Report of the Company on Form 10-K/A filed
April 29, 1996 amending the 1995 10-K.
3. The Quarterly Report of the Company on Form 10-Q for
the quarter ended March 31, 1996.
4. The description of the Company's Common Stock set
forth in the Company's Registration Statement on Form
8-A, filed with the Commission on August 4, 1987.
All documents filed by the Company pursuant to section 13(a), 13(c), 14
or 15(d) of the Exchange Act, subsequent to the date of this Prospectus and
prior to the termination of the offerings to which this Prospectus relates shall
be deemed to be incorporated by reference in this Prospectus and to be a part
hereof from the date of filing of such documents. Any statement in a document
incorporated or deemed to be incorporated by reference herein shall be deemed to
be modified or superseded by this Prospectus to the extent that a statement
contained herein or in any other subsequently filed document which also is or is
deemed to be incorporated by reference herein modifies or supersedes such
statement. Any such statement so modified or superseded shall not be deemed,
except as so modified or superseded, to constitute a part of this Prospectus.
<PAGE>
The Company hereby undertakes to provide without charge copies of all
documents incorporated herein by reference (other than exhibits to such
documents unless such exhibits are specifically incorporated by reference in
such documents) to each person, including any beneficial owner, to whom a copy
of this Prospectus has been delivered on the written or oral request of such
person to: William Steinhauer, Controller, 110 Little Falls Road, Fairfield, New
Jersey 07004 (telephone number (201)882-0860).
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements in this Prospectus under the captions "Risk Factors"
and "The Company" constitute "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995 (the "Reform Act"). Such
forward-looking statements involve known and unknown risks, uncertainties and
other factors that may cause the actual results, performance or activities of
the Company, or industry results, to be materially different from any future
results, performance or activities expressed or implied by such forward-looking
statements. Such factors include: general economic and business conditions, the
financial condition of the Company, competition, the Company's dependence on
other companies to commercialize, manufacture and sell products using the
Company's technologies, the uncertainty of results of preclinical and clinical
testing, the risk of product liability and liability for human clinical trials,
the Company's dependence on patents and other proprietary rights, dependence on
key management officials, the availability and cost of capital, the availability
of qualified personnel, changes in, or the failure to comply with, governmental
regulations, the failure to obtain regulatory approvals of the Company's
products and other factors discussed in this Prospectus. See "Risk Factors".
RISK FACTORS
Prospective investors should consider carefully the following factors
concerning the Company and its business before purchasing securities offered by
this Prospectus. Certain statements under this caption constitute
"forward-looking statements" under the Reform Act. See "Special Note Regarding
Forward-Looking Statements."
Absence of Operating Revenues and Liquidity; History of Losses;
Auditors' Report - Going Concern Considerations. The Company has incurred annual
operating losses since its inception and, as a result, at March 31, 1996, had an
accumulated deficit of $35,700,000. The Company has not received any significant
operating revenues during the last five years.
In addition to operating its production facility and seeking approval
for its Calcitonin for human use, the Company intends to continue certain
internally funded research activities such as the development of a Calcitonin
pill, all of which will contribute to continuing losses from operations. All of
the Company's contracts to perform sponsored research have been completed or
cancelled and, at present, it has almost no operating revenues. It is unlikely
that the Company's operating results will improve unless it is able to license
its technology, obtain new projects, or successfully produce and sell its
products. The Company may continue to incur losses over the next several years.
The auditors' report for the fiscal year ended December 31, 1995 contains an
explanatory paragraph indicating there is substantial doubt about the Company's
ability to continue as a going concern.
<PAGE>
The Company has sufficient financial resources to sustain its
operations at the current level through approximately the third quarter of 1996.
To continue its operations beyond that time will require that the Company enter
into additional financing transactions or marketing, joint venture or licensing
agreements. There can be no assurance that any such financings will occur or
that any such agreements will be entered into by the Company.
Transition to Production; Possibility of Delays or Inability to
Manufacture and Market Products. The Company is currently undergoing a
transition from its historical research orientation toward a business with a
pharmaceutical production focus. Accordingly, the Company is likely to incur the
problems, delays, expenses and difficulties typically encountered by enterprises
in the Company's stage of transition, many of which may be beyond the Company's
control.
No product of the Company has been commercialized for human
pharmaceutical use. The commercial manufacture and sale of any such product will
require the approval of the U.S. Food and Drug Administration ("FDA") and by
comparable regulatory authorities outside of the United States. See "Risk
Factors - Government Regulation." There can be no assurance that clinical
testing will be successful or that the clinical results will be adequate to
support regulatory submissions. Furthermore, there can be no assurance that the
Company's products will be demonstrated to be safe and effective or that they
will be approved by the appropriate regulatory authorities. Even if any such
products are approved, there is no assurance that they can be manufactured in
commercial quantities at reasonable costs. Due to the Company's limited
clinical, manufacturing and regulatory experience and the absence of a marketing
organization, it may be necessary for the Company to rely on sponsors or other
parties to perform such tasks for the commercialization of pharmaceutical-grade
products. See "Risk Factors - Dependence on Large Pharmaceutical Companies."
Expanded consumer acceptance of pharmaceutical-grade Calcitonin may be
dependent on development of a consumer acceptable delivery system. The Company
and others are conducting research on new delivery systems for Calcitonin
including oral technology. There can be no assurance that the Company will
develop suitable oral delivery systems or that governmental approval of any such
delivery system will be obtained. There can also be no assurance that others
will not develop oral or other delivery systems that could compete with or
surpass any oral delivery system developed by the Company. Moreover, there are
non-Calcitonin products currently being marketed for osteoporosis treatment and
other non-Calcitonin products in development that will compete with Calcitonin
products. See "Risk Factors - Technological Change and Competition."
There can be no assurance that the Company will have sufficient
financial resources to fund its operations until such time as it is able to
generate revenues that are sufficient to sustain its operations. See "Risk
Factors - Absence of Operating Revenues and Liquidity; History of Losses;
Auditors' Report - Going Concern Considerations."
New Production Facility. During 1994, the Company completed
construction of a facility for the production of pharmaceutical-grade Calcitonin
and other peptide hormones. The Company is leasing the facility under a 10-year
agreement which began in February 1994. The Company has two 10-year renewal
options as well as an option to purchase the facility. The Company is
undertaking steps to secure FDA validation of the facility which would allow it
to manufacture Calcitonin for human pharmaceutical use. The facility has begun
producing Calcitonin in accordance with current Good Manufacturing Practice
("cGMP") regulations, but there is no assurance that the facility will be
approved by the FDA. Furthermore, there can be no assurance that the facility
<PAGE>
will be able to achieve its production goals, that production at this facility
will be profitable to the Company, that others will not develop processes and
products superior to, or otherwise precluding the Company from commercial
utilization of this facility, that there will be a market for the Company's
products produced by the facility, or that sufficient funds will be available
for the Company to complete the pre-production process or to produce and market
its products from the facility.
Dependence on Large Pharmaceutical Companies. The Company has been and
expects to continue to be dependent on large pharmaceutical companies for
revenues from sales of product, research sponsorship, joint ventures and
licensing arrangements. During the 1987 to 1990 period, the Company's operating
revenues resulted primarily from research which was totally or substantially
funded by pharmaceutical companies. The Company currently has no sponsored
research projects. There is no assurance that the Company will be successful in
its efforts to enter into new research or licensing agreements or other revenue
producing arrangements.
The Company's past contracts with certain pharmaceutical company
sponsors provide for payment of royalties to the Company on commercial sales of
the products of sponsored research projects. However, there can be no assurance
that such sponsors will successfully commercialize any product based on the
Company's technology. It currently is unlikely that the Company will receive any
material royalties under such past agreements.
In June 1995, the Company entered into a joint venture agreement with
the Qingdao General Pharmaceutical Company and its Huanghai factory for the
production and marketing of Calcitonin in China. Under the agreement, the
Chinese partners will finance the project, including the construction and
operation of a dedicated manufacturing facility in China which will utilize the
Company's propriety production technology. The Company will provide the joint
venture with technology and training as well as the Company's proprietary enzyme
at a discounted price. The Company will receive a combination of fixed fees and
minimum annual royalties based upon sales of the end product. There is no
assurance that this joint venture will be successful or that the Company will
receive significant income from the joint venture.
Risks of International Operations. The Company's potential major
customers, partners and licensees include foreign companies or companies with
significant international business. The business operations of such companies
and their ability to pay license fees, royalties and other amounts due and
otherwise to perform their obligations to the Company under agreements with the
Company may be subject to approval or regulation by foreign governments. There
can be no assurance that required approvals will be received. The failure to
receive required approvals, governmental regulations and other risks, including
political and foreign currency risks, could affect the ability of the Company to
earn or receive payments pursuant to such agreements and, in such event, may
have a material adverse effect on the Company's future operations.
<PAGE>
Technological Change and Competition. The Company has concentrated most
of its efforts on one product - the use of Calcitonin for the treatment of
osteoporosis. The market for this treatment of osteoporosis is subject to rapid,
unpredictable and significant technological change. Competition from specialized
biotechnology companies, major pharmaceutical and chemical companies and
universities and research institutions is intense. Most of the competitors of
the Company have substantially greater financial and other resources than does
the Company. There can be no assurance that developments by others, including
alternative chemical means of amidation, alternative processes which eliminate
the need for amidation, and new delivery systems and other osteoporosis
treatments, will not render the Company's technologies and products derived
therefrom obsolete or noncompetitive.
Product Liability. Product liability claims relating to the Company's
technology or products may be asserted against the Company. There can be no
assurance that the Company will have sufficient resources to defend against or
satisfy any such liability. Although the Company has recently obtained product
liability insurance coverage, product liability or other judgments against the
Company in excess of insurance limits could have a material adverse effect upon
the Company's business and financial condition.
Patents and Proprietary Technology. The Company has filed applications
for U.S. patents relating to the proprietary amidation and immunization
processes and Calcitonin pill invented in the course of its research. To date,
the following two patents have issued: Immunization By Immunogenic Implant, a
process patent, and Alpha-Amidation Enzyme, a process and product patent. Other
applications are pending. Filings related to the amidation process have also
been made in selected foreign countries and nine such foreign patents have
issued. There can be no assurance that any of the Company's pending applications
will issue as patents or that the Company's issued patents will provide the
Company with significant competitive advantages. Furthermore, there can be no
assurance that competitors will not independently develop or obtain similar or
superior technologies. Although the Company believes its patents and patent
applications are valid, the invalidation of its Alpha-Amidation Enzyme patent or
the failure of certain of its pending Alpha-Amidation Enzyme-related
applications to issue as patents could have a material adverse effect upon the
Company's business. Difficulties in detecting and proving infringement are
generally greater with process patents than with product patents. In addition,
the value of a process patent may be reduced if the products that can be
produced using such process have been patented by others. Under such
circumstances, the cooperation of these patent holders or their sublicensees
would be needed for the commercialization of the aforementioned patented
products in countries where these companies hold valid patents.
In some cases, the Company relies on trade secrets to protect its
inventions. It is the policy of the Company to include in all research
contracts, joint development agreements and consulting relationships that
provide access to the Company's trade secrets and other know-how confidentiality
obligations binding on the parties involved. However, there can be no assurance
that these secrecy obligations will not be breached to the detriment of the
Company. To the extent sponsors, consultants or other third parties apply
technological information independently developed by them or by others to
Company projects, disputes may arise as to the proprietary rights to such
information which may not be resolved in favor of the Company.
<PAGE>
Government Regulation. The laboratory research activities of the
Company and its sponsors, collaborators and licensees, and the processes and
products which may be developed by them and the new production facility, are
subject to significant regulation by numerous federal, state, local and foreign
governmental authorities. In addition to obtaining the FDA's validation of the
new facility, it is necessary to obtain FDA approval for human use of the
Calcitonin to be produced in the facility. This will require various human and
animal studies. The Company will then apply to the FDA for approval of the
Company's Calcitonin for human use. The regulatory process for a pharmaceutical
product may take a number of years and requires substantial resources. In the
case of the regulatory process for the Company's Calcitonin products, the
Company believes that it may be possible to abbreviate the process. However,
there can be no assurance that regulatory approval will be obtained for the new
facility or any of the Company's products. The inability to obtain, or delays in
obtaining, such approvals would adversely affect the Company's ability to
continue to fund its programs, produce marketable products, or to receive
revenue from product sales or royalties. Furthermore, the extent of any adverse
governmental regulation that may arise from future legislative and
administrative action cannot be predicted.
Dependence on Key Executives. Drs. Warren and Ronald Levy have been the
principal executive officers of the Company since its inception. The Company
relies on them for their leadership and scientific direction. Neither Dr. Warren
P. Levy nor Dr. Ronald S. Levy has an employment agreement with the Company.
Each of them has entered into an agreement with the Company providing that he
shall not engage in any other employment or business for the period of his
employment with the Company. At the present time, the loss of the services of
either of these individuals could have a material adverse impact on the
Company's business.
Attraction and Retention of Key Personnel. The Company's ability to
obtain required governmental approvals, produce its products, obtain research
contracts and develop new technologies will depend in part on its ability to
attract and retain highly qualified scientific personnel. Competition for such
personnel is intense. There can be no assurance that the Company will be able to
attract and retain such personnel.
<PAGE>
Shares Eligible For Future Sale; Outstanding Convertible Securities,
Warrants And Options. Other than the 7,982,177 shares of Common Stock to be
issued to which this Prospectus relates, there are 7,702,201 shares of Common
Stock that are registered under the Securities Act and were issued or are
issuable as follows:
2,869,565 shares of Common Stock were issued or are issuable by the
Company to holders of $3,300,000 aggregate principal amount of the Company's
9.5% Senior Secured Convertible Debentures (the "Debentures") upon conversion of
the Debentures; the Debentures were issued by the Company in a private
transaction on March 6, 1996 and initially are convertible into Common Stock at
a conversion rate of $1.15 per share. 3,681,536 shares of Common Stock were
issued or are issuable by the Company to holders upon exercise of warrants of
the Company (the "Warrants"); the Warrants were issued by the Company between
October 1994 and April 1996 in consideration of certain financial and consulting
services performed for the Company or in connection with loans to the Company
and initially are exercisable at prices ranging from $1.375 to $3 per share.
115,000 shares of Common Stock were issued or are issuable by the Company to
holders upon exercise of options granted by the Company (the "Options"); the
Options were granted by the Company between January 1993 and April 1996 in
consideration of certain consulting services performed for the Company by the
holders thereof and are exercisable at prices ranging from $1.4375 to $4.5625
per share. 826,000 shares of Common Stock were issued by the Company to certain
stockholders in a private placement completed February 1996. 10,000 shares of
Common Stock were issued by the Company in a private placement covered by a
separate registration statement. 200,100 shares of Common Stock were or will be
issued by the Company to certain other holders. 10,000 of such shares of Common
Stock will be issued in consideration for services performed for the Company.
190,100 of such shares of Common Stock were issued upon the exercise of options
in connection with certain loans made to the Company in 1985. One of the
holders, Jay Levy, is one of the founders of the Company and currently serves as
the Chairman of the Board of Directors and Treasurer of the Company. Mr. Levy
acquired 109,350 shares of Common Stock on June 21, 1994 for $150,000 upon the
exercise of such a stock option.
In addition, as of June 25, 1996, approximately 2,700,000 shares of
Common Stock are issuable upon conversion of the balance of the Company's 10%
convertible debentures; and 1,603,265 shares are issuable under purchase options
exercisable at prices ranging from $1.00 to $3.00 per share. In addition,
4,138,350 outstanding shares of Common Stock are "restricted securities" as that
term is defined by Rule 144 promulgated under the Securities Act. Such
restricted securities may be sold only in compliance with Rule 144, or pursuant
to registration under the Securities Act or pursuant to another exemption
therefrom. The Company may issue additional convertible securities, options,
warrants and shares in the future. Transactions by the Company, or the
occurrence of certain other future events, may require adjustment of the
exercise or conversion price and other terms of the Company's convertible
securities, options and warrants including, in some circumstances, an increase
in the number of shares issuable thereunder.
The Company cannot predict the adverse effect that market sales of
Common Stock, the conversion of such convertible securities, the exercise of
such options or warrants, or the availability of Common Stock for sale will have
on the market price of the Common Stock prevailing from time to time, although
it is likely that sales of a large number of securities would depress such
market price. The Company also cannot predict the adverse effect, if any, that
such convertible securities, options, warrants and shares available for sale
will have on the ability of the Company to obtain additional capital or the
terms and conditions thereof.
<PAGE>
Possible Volatility of Securities Prices. The market prices of the
Company's securities may be highly volatile. Factors such as announcements by
the Company or others of technological innovations, regulatory matters, new
products or procedures, proposed government regulations, developments or
disputes relating to patents or proprietary rights, and public concern over the
safety of activities or products may have a significant impact on the market
price of the Company's securities. In addition, future sales of shares of Common
Stock by shareholders and by the holders of convertible securities, warrants and
options could have an adverse effect on the prices of the Company's securities.
See "Risk Factors - Shares Eligible for Future Sale; Outstanding Convertible
Securities, Warrants and Options."
Voting Control. Warren P. Levy, Ronald S. Levy and Jay Levy, founders
of the Company, beneficially own, approximately 16% of the outstanding Common
Stock (assuming that outstanding convertible securities, warrants and options
held by others are not converted or exercised) and, thus, effectively may have
the ability to elect the entire Board of Directors and control the affairs of
the Company.
Dividends. The Company has not paid any cash dividends on its Common
Stock since its inception and anticipates that, for the foreseeable future, it
will not pay any cash dividends.
Limitation of Marketability of Company Securities. The Common Stock
currently is traded on the Nasdaq National Market. In order for the Common Stock
to continue to qualify for inclusion on the Nasdaq National Market, among other
requirements, the Company must have net tangible assets of at least $4.0
million. As of March 31, 1996 the amount of the Company's net tangible assets
was approximately $3.0 million. See "Risk Factors - Absence of Operating
Revenues and Liquidity; History of Losses; Auditors' Report - Going Concern
Considerations." The Company has been advised by the National Association of
Securities Dealers, Inc. (the "NASD") that due to a deficiency in its net
tangible assets, at March 31, the Company currently does not qualify for the
listing of its Common Stock on the Nasdaq National Market. The Company is
appealing this determination. If the Company is unable to develop a plan
satisfactory to the NASD by which it will be able to restore and maintain
compliance with the Nasdaq National Market listing requirements, the Common
Stock will be removed from trading on the Nasdaq National Market. There is no
assurance, however, that the Company will be successful in preventing the
removal of the Common Stock from trading on the Nasdaq National Market. If the
Common Stock is removed from trading on the Nasdaq National Market, the Company
intends to make an application for the listing of the Common Stock on the Nasdaq
SmallCap Market. If the Company fails to meet the requirements for trading on
the Nasdaq National Market and does not qualify for listing in the Nasdaq
SmallCap Market, the holders of Common Stock may find it difficult to obtain
accurate quotations as to the market value of the Common Stock and may
experience greater difficulties in attempting to sell the Common Stock than if
it were listed on a stock exchange or quoted on the Nasdaq National Market or
the Nasdaq SmallCap Market.
If the Common Stock is not traded on the Nasdaq National Market or the
Nasdaq SmallCap Market, and the market price of the Common Stock is less than
$5.00 per share, the Common Stock would be classified as a "penny stock." As
such the Common Stock would be subject to Rule 15g-9 under the Exchange Act,
which imposes additional sales practice requirements on broker-dealers that
recommend the purchase or sale of such securities to persons other than a person
who qualifies as an "established customer" or an "accredited investor." Among
these requirements is that a broker-dealer must make a determination that
investments in penny stocks are suitable for the customer and must make certain
<PAGE>
special disclosures to the customer concerning the risks of penny stocks.
Application of the penny stock rules to the Common Stock could adversely affect
the market liquidity of such securities, which in turn may affect the ability of
the holders of the Common Stock to resell the securities.
THE COMPANY
Unigene Laboratories, Inc. is a health-care oriented biotechnology
company which is engaged in research and production of cGMP Calcitonin and is
planning to engage in the production and marketing in bulk of pharmaceutical
grade Calcitonin. Certain statements under this caption constitute
"forward-looking statements" under the Reform Act. See "Special Note Regarding
Forward-Looking Statements". The Company's current business focus has shifted
toward pharmaceutical production from its historical research orientation. The
Company has succeeded in combining its proprietary amidation process with
bacterial recombinant DNA technology to develop a peptide hormone production
process. The Company believes that its proprietary amidation process will be a
key step in the more efficient and economical commercial production of certain
peptide hormones with diverse therapeutic applications. Many of these hormones
cannot be produced at a reasonable cost in sufficient quantities for clinical
testing or commercial use by currently available production processes. Using its
proprietary process, the Company has produced laboratory-scale quantities of
seven such peptide hormones: human Calcitonin, salmon Calcitonin, human Growth
Hormone Releasing Factor, human Calcitonin Gene-Related Peptide, human
Corticotropin Releasing Factor, human Amylin and a human Magainin. During 1991,
a study commissioned by the Company was prepared by a professor of chemical
engineering at the Massachusetts Institute of Technology. The study evaluated
the economics for producing multi-kilogram quantities of Calcitonin and
indicated that the Company's process for producing Calcitonin should reduce the
cost and time required for commercial production by up to 95%.
The Company's strategy is to develop proprietary products and processes
with applications in human health-care, independently or in conjunction with
pharmaceutical and chemical companies, in order to generate revenues from
license fees, royalties and product sales in bulk. Generally, the Company seeks
sponsors and licensees to provide research funding and assume responsibility for
obtaining appropriate regulatory approvals, clinical testing, production and
marketing of products derived from the Company's research activities. It has
concentrated most of its efforts on one product - Calcitonin for the treatment
of osteoporosis. The Company has built a production facility and plans to
undertake production of pharmaceutical grade Calcitonin and will assume
responsibility for the clinical testing and/or applying for regulatory approval
for certain Calcitonin products.
Since 1992, the Company has been producing and from time to time
selling small quantities of research-grade salmon Calcitonin. During 1993, the
Company began construction of a cGMP facility for the production of
pharmaceutical-grade Calcitonin in leased premises located in Boonton, New
Jersey which was mechanically completed during the fourth quarter of 1994. The
facility will also produce the Company's proprietary amidating enzyme for use in
producing Calcitonin. The initial production capacity of the facility is
expected to be between 0.5-1.0 kilogram of bulk Calcitonin per year,
representing approximately 10% of the current estimated world supply for this
leading osteoporosis drug.
<PAGE>
The Company is following conventional procedures in order to secure the
validation of the facility by the FDA in order to allow the Company to provide
its Calcitonin for human use. Although the facility was inspected by an
independent consultant and found to be in compliance with cGMP guidelines, there
can be no assurance that FDA validation will occur. In addition there is no
assurance that the facility production goals will be achieved, that there will
be a market for the Company's products, that such production will be profitable
to the Company, that others will not develop processes and products superior to,
or otherwise precluding the commercial utilization of, the processes or products
developed by the Company. The design of the facility is intended to allow for
substantial increases in Calcitonin production utilizing the existing equipment
with no additional capital expenditures or personnel. Although the facility will
initially be exclusively devoted to Calcitonin production, it would be suitable
for producing other peptide hormone products in the future. There can be no
assurance that there will be sufficient acceptance of the Company's products in
the marketplace for successful commercialization. See "Risk Factors - New
Production Facility."
In addition to obtaining the FDA's validation of the new facility, it
is necessary to obtain regulatory approval in each country for human use of the
salmon Calcitonin to be produced in the facility. This will require various
human and animal studies. The Company will then apply to the appropriate
regulatory agencies for approval of the Company's Calcitonin for human use. The
Company requested in May 1996 that the regulatory authority for drugs in the
United Kingdom authorize the Company to conduct pivotal clinical Phase III
trials of its injectable form of Calcitonin, which request was granted in June
1996. The Company expects the trial to be completed during the fourth quarter of
1996. The Company plans to apply for marketing authorization throughout the
European Union soon after completion of the clinical trial. In addition, the
Company recently filed an Investigational New Drug (IND) application for its
injectable form of Calcitonin with the FDA. However, there can be no assurance
that the studies will produce satisfactory results or that the necessary
governmental approvals will be obtained as projected.
Expanded consumer acceptance of pharmaceutical-grade Calcitonin may
be dependent on development of a consumer acceptable delivery system. A major
pharmaceutical company received FDA approval during 1995 for the marketing of a
nasal spray delivery system for Calcitonin, which could enlarge the market for
Calcitonin. The Company and others are conducting research on oral delivery
systems for Calcitonin. There can be no assurance that suitable delivery systems
will be developed or that governmental approval of such delivery systems will be
obtained.
The Company is continuing its efforts to develop a Calcitonin pill. In
December, 1995 and the first half of 1996, the Company successfully tested its
proprietary Calcitonin pill in Phase I clinical trials in the United Kingdom.
The latest of these studies indicated that all of the subjects who received the
pill showed levels of the hormone in blood samples taken during the trial which
are greater than levels generally regarded as required for maximal therapeutic
benefit. The Company believes that this is the first time significant blood
levels of Calcitonin have been observed in humans following oral administration
of the hormone. However, there is no assurance that these results will be
replicated in further studies. The Company has recently filed a patent
application for its oral formulation with the U.S. Patent and Trademark Office
and plans to file an Investigational New Drug (IND) application with the FDA.
There can be no assurance that applications will be approved as projected or
that the Company will be successful in marketing its products.
<PAGE>
The planned activities of the Company are all subject to obtaining
adequate financing. There can be no assurance that the Company will have
sufficient resources to complete the preproduction process, to produce and
market its products and to carry on its other projects. See "Risk Factors -
Absence of Operating Revenues and Liquidity; History of Losses; Auditors' Report
- - - - Going Concern Considerations."
The Company is currently engaged in two collaborative research
programs. One, with Rutgers University College of Pharmacy, seeks to develop an
oral drug delivery system for Calcitonin. The second collaboration, performed in
conjunction with Yale University, is investigating novel applications for
certain amidated peptide hormones, including CGRP, Calcitonin gene-related
peptide.
At present, the Company has no third party sponsored research
agreements in effect. The Company is currently conducting discussions with major
pharmaceutical companies regarding licensing and/or research agreements. There
can be no assurance that such discussions will result in new research or
licensing agreements or that the Company will be able to obtain adequate funding
for its current or new projects. The Company is dependent on large
pharmaceutical companies, having much greater resources than the Company, for
revenues from sales of product, research sponsorship, joint ventures and
licensing arrangements. See "Risk Factors - Dependence on Large Pharmaceutical
Companies" and "Risk Factors - Risks of International Operations."
The Company has established a multi-disciplinary research team to adapt
current genetic engineering technologies to the development of proprietary
products and processes. The Company, at June 1, 1996, had 60 full-time
employees, including 25 research and development personnel and 24 pre-production
personnel. 10 employees have Ph.D. degrees in the fields of molecular biology,
microbiology, biochemistry, pharmacology or organic chemistry. The Company's
employees have expertise in molecular biology, including DNA cloning, synthesis,
sequencing and expression; protein chemistry, including purification, amino acid
analysis, synthesis and sequencing proteins; immunology, including tissue
culture, monoclonal and polyclonal antibody production and immunoassay
development; chemical engineering; pharmaceutical production; quality assurance;
and quality control. None of the Company's employees is covered by a collective
bargaining agreement.
The Company was incorporated under the laws of the State of Delaware in
November 1980. Its executive offices and laboratory facilities are located at
110 Little Falls Road, Fairfield, New Jersey, 07004, and its telephone number is
(201)882-0860.
PLAN OF DISTRIBUTION
The securities covered by this Prospectus were registered as part of
the Company's initial public offering and are issuable upon exercise of Class B
Warrants which were obtained upon exercise of Class A Warrants during 1991.
<PAGE>
Upon the exercise of the Class B Warrants, the Company will pay D.H.
Blair & Co., Inc. ("Blair"), the underwriter of the Company's initial public
offering in 1987, a fee of 4% of the aggregate exercise price, of which 1% may
be reallowed to any dealer who solicited the exercise (which may also be Blair)
if (i) the market price of the Company's Common Stock on the date the Class B
Warrant is exercised is greater than the then exercise price of the Class B
Warrants; (ii) the exercise of the Class B Warrant was solicited by a member of
the NASD; (iii) the Class B Warrant is not held in a discretionary account; (iv)
disclosure of compensation arrangements was made both at the time of the
offering and at the time of exercise of the Class B Warrants; and (v) the
solicitation of exercise of the Class B Warrant was not in violation of Rule
10b-6 promulgated under the Securities Exchange Act of 1934. Unless granted an
exemption by the Securities and Exchange Commission from its Rule 10b-6, Blair
and any soliciting broker-dealers will be prohibited from engaging in any market
making activities with regard to the issuer's securities for the period from
(two or nine) business days prior to any solicitation of the exercise of Class B
Warrants until the later of the termination of such solicitation activity or the
termination (by waiver or otherwise) of any right that Blair and soliciting
broker-dealers may have to receive a fee for the exercise of Class B Warrants
following such solicitation. As a result, Blair and soliciting broker-dealers
may be unable to continue to provide a market for the issuer's securities during
certain periods while the Warrants are exercisable.
DESCRIPTION OF SECURITIES
The Securities issuable upon exercise of the Class B Warrants are
shares of Common Stock. The Common Stock obtained upon exercise of the Class B
Warrants will be transferable immediately.
The Company has listed the Common Stock and Class B Warrants on the
automated quotation system of the National Association of Securities Dealers,
Inc. ("NASDAQ"). The Company's Common Stock and Class B Warrants are listed on
the NASDAQ National Market System under the market symbols "UGNE" and "UGNEZ",
respectively.
Common Stock
The authorized capital stock of the Company consists of 48,000,000
shares of Common Stock, $.01 par value per share. On June 20, 1996, 26,268,676
shares of Common Stock held by 603 stockholders of record were outstanding and
10,985,366 additional shares of Common Stock were issuable upon exercise of
outstanding stock options, warrants and conversion of convertible debentures.
See "Risk Factors -- Shares Eligible for Future Sales; Outstanding Convertible
Securities, Warrants and Options".
The holders of validly issued and outstanding shares of Common Stock
are entitled to one vote per share on all matters to be voted upon by
stockholders including the election of directors. There is no cumulative voting
with respect to the election of directors, which means that the holders of a
majority of the shares can elect all the directors if they choose to do so, and
in such event, the holders of the remaining shares would not be able to elect
any directors.
<PAGE>
The holders of Common Stock have no preemptive or conversion rights,
nor are there any redemption rights provisions with respect to Common Stock. The
outstanding shares are, and the shares subject to issuance pursuant to options
and warrants when issued and paid for, will be fully paid and nonassessable and
not subject to further call or assessment by the Company. The holders of Common
Stock are entitled to such dividends, if any, as may be declared by the Board of
Directors in its discretion out of funds legally available for that purpose and
to participate pro rata in any distribution of the Company's assets upon
liquidation.
Class B Warrants
On June 20, 1996, 5,594,069 Class B Warrants held by 56 warrant
holders of record were outstanding. Each Class B Warrant entitles the registered
holder to purchase 1.4269 shares of Common Stock at an exercise price of $3.504
at any time prior to 5:00 P.M., New York City Time, on the earlier of August 11,
1996 or the business day immediately preceding the date fixed by the Company for
redemption of the Class B Warrants. The Class B Warrants are redeemable by the
Company on thirty days written notice at a redemption price of $.035 per Class B
Warrant, provided the average of the closing prices of the Company's Common
Stock (or the closing bid prices if closing prices are not reported or
available) for the thirty consecutive business days ending within fifteen days
of the notice of redemption exceeds $4.9056 per share. All Class B Warrants must
be redeemed if any are redeemed.
The issuance of Class B Warrants is governed by a warrant agreement
(the "Warrant Agreement") among the Company, Blair and Registrar and Transfer
Company, Cranford, New Jersey, as warrant agent, and are evidenced by Class B
Warrant certificates in registered form. The Class B Warrants provide for
adjustment of the exercise price and for a change in the number of shares
issuable upon exercise to protect holders against dilution in the event of a
stock dividend, stock split, combination or reclassification of the Common Stock
or upon issuance of shares of Common Stock at prices lower than the Class B
Warrant exercise price then in effect other than issuances upon exercise of
existing options and options granted to employees, directors and consultants to
the Company.
The Class B Warrants may be exercised upon surrender of the Class B
Warrant certificate on or prior to the expiration date (or earlier redemption
date) of such Class B Warrants at the offices of Registrar and Transfer Company,
the warrant agent, with the form of "Election to Purchase" on the reverse side
of the Class B Warrant certificate completed and executed as indicated,
accompanied by payment of the full exercise price (by certified or bank check
payable to the order of the Company) for the number of shares with respect to
which the Class B Warrants are being exercised. The right to exercise Class B
Warrants will be forfeited if not effected prior to the aforesaid expiration
dates or earlier redemption dates. Shares issued upon exercise of Class B
Warrants and payment in accordance with the terms of the Class B Warrants will
upon issuance be fully paid and nonassessable.
The Class B Warrants do not confer upon the warrantholder any voting or
other rights of a stockholder of the Company. Upon notice to the warrantholders,
the Company has the right to reduce the exercise price or extend the expiration
date of Class B Warrants.
<PAGE>
LEGAL MATTERS
Certain legal matters in connection with the securities offered hereby
are being passed upon for the Company Becker Ross Stone DeStefano & Klein, New
York, N.Y. The wife of James J. Ross, an attorney who is of counsel to Becker
Ross Stone DeStefano & Klein, holds a one-third interest in a family partnership
which is the beneficial owner of 18,225 shares of the Company's Common Stock.
EXPERTS
The audited financial statements of Unigene Laboratories, Inc. as of
December 31, 1995 and 1994 and for each of the years in the three year period
ended December 31, 1995 incorporated by reference in this Prospectus have been
incorporated by reference herein in reliance upon the report of KPMG Peat
Marwick LLP, independent certified public accountants, incorporated by reference
herein, and upon the authority of said firm as experts in accounting and
auditing.
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution*
The expenses payable by the Registrant in connection with the issuance
and distribution of the securities being registered hereby (other than
underwriting discounts and commissions) are set forth below:
Accounting Fees and Expenses........................ 2,500
Legal Fees and Expenses............................. 10,000
Miscellaneous Expenses................................. 0
Printing Costs....................................... 0
------
Total 12,500
- - - ----------------------------------
* All expenses are estimated.
Item 15. Indemnification of Directors and Officers
Article VI of the Company's By-Laws requires the Company to indemnify
each of its directors and officers to the extent permitted by the Delaware
General Corporation Law (the "DGCL"). Section 145 of the DGCL provides that a
corporation may indemnify any person, including any officer or director, who was
or is a party or who is threatened to be made a party to any threatened, pending
or completed action, suit or proceeding, whether civil, criminal, administrative
or investigative (other than an action by or in the right of the corporation),
by reason of the fact that he is or was a director, officer, employee or agent
of the corporation or is or was serving at the request of the corporation as a
director, officer, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise, against expenses (including attorneys'
fees), judgments, fines and amounts paid in settlement, actually and reasonably
incurred by such person, if he acted in good faith and in a manner he reasonably
believed to be in or not opposed to the best interests of the corporation and,
with respect to any criminal action or proceeding, had no reasonable cause to
believe his conduct was unlawful. In any threatened pending or completed action
by or in the right of the corporation, a corporation also may indemnify any
director, officer, employee or agent for costs actually and reasonably incurred
by him in connection with the defense or settlement of the action, if he acted
in good faith and in a manner reasonably believed to be in or not opposed to the
best interests of the corporation; however, no indemnification may be made with
respect to any claim, issue or matter as to which such person shall have been
adjudged to be liable to the corporation, unless and only to the extent that a
court shall determine that such indemnity is proper. Where a director, officer,
employee or agent is successful on the merits or otherwise in the defense of any
action referred to above, the corporation is required to indemnify such person
against the expenses (including attorneys' fees) actually and reasonably
incurred.
The Company's Certificate of Incorporation provides that its directors
shall not be liable for monetary damages to the Company or its stockholders for
breach of the directors' fiduciary duty as directors. However, each director is
<PAGE>
subject to liability for breach of the director's duty of loyalty to the Company
or its stockholders, for acts or omissions not in good faith or involving
intentional misconduct or knowing violations of law, for actions leading to
improper personal benefit to the director, and for payment of dividends or
approval of stock repurchases or redemptions that are unlawful under Delaware
law.
<PAGE>
Item 16. Exhibits*
3.1 Certificate of Incorporation
3.1.1 Amendments to Certificate of Incorporation
3.2 By-Laws^ (incorporated by reference to Exhibit 4.2 to Company's
Registration Statement No. 333-04557 on Form S-3).
4.1.1 Amended Form of Warrant Agreement.
5.1 Opinion of Becker Ross Stone DeStefano & Klein as to the legality of
certain of the shares being registered.
23.1 Consent of Independent Certified Public Accountants.
23.2 Consent of Becker Ross Stone DeStefano & Klein (included in opinion
filed as Exhibit 5.1).
24.1 Powers of Attorney of Directors of Unigene Laboratories, Inc.
(included on page II-4).
Item 17. Undertakings
The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to the Registration
Statement:
(i) To include any prospectus required by section
10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events
arising after the effective date of the registration
statement (or the most recent post-effective
amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the
information set forth in the registration statement.
Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the
total dollar value of securities offered would not
exceed that which was registered) and any deviation
from the low or high end of the estimated maximum
offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule
424(b) if, in the aggregate, the changes in volume
and price represent no more than a 20% change in the
maximum aggregate offering price set forth in the
"Calculation of Registration Fee" table in the
effective registration statement.
(iii) To include any material information with respect to
the plan of distribution not previously disclosed in
the registration statement or any material change to
such information in the registration statement;
Provided, however, That paragraphs (a)(1)(i) and (a)(1)(ii) of
this section do not apply if the information required to be
included in a post-effective amendment by those paragraphs is
contained in periodic reports filed with or furnished to the
Commission by the Registrant pursuant to section 13 or section
15(d) of the Securities Exchange Act of 1934 that are
incorporated by reference in the registration statement.
<PAGE>
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment
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.
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered which remain
unsold at the termination of the offering.
The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
Registrant's annual report pursuant to section 13(a) or section 15(d) of the
Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to Section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
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.
Insofar as indemnification for liabilities arising under the Securities
Act of 1933 ("Act") may be permitted to directors, officers or controlling
persons of the Registrant by charter, by-law, contract, statute 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 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 Act and will
be governed by the final adjudication of such issue.
- - - --------
*Except as otherwise noted, these exhibits have been filed.
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933 certifies
that it has reasonable grounds to believe that it meets all of the requirements
for filing on Form S-3 and the Registrant has duly caused this Registration
Statement to be signed on its behalf by the undersigned thereunto duly
authorized, in Fairfield, New Jersey, on the 28th day of June, 1996.
UNIGENE LABORATORIES, INC.
By /s/ WARREN P. LEVY
Warren P. Levy, President
Pursuant to the requirements of the Securities Act of 1933, as amended,
this Registration Statement has been signed below by the following persons in
the capacities and on the dates indicated:
Signature Title Date
- - - --------- ----- ----
/s/ WARREN P. LEVY Director, President (principal June 28, 1996
Warren P. Levy executive officer)
/s/ RONALD S. LEVY Director, Vice President June 28, 1996
Ronald S. Levy
/s/ JAY LEVY Chairman of the Board of Directors, June 28, 1996
Jay Levy Treasurer (principal financial and
accounting officer)
*
Robert Ruark Director June 28, 1996
*
George M. Weimer Director June 28, 1996
*By /s/ RONALD S. LEVY
(Ronald S. Levy)
Attorney-in-Fact
June 28, 1996
EXHIBIT 23.1
CONSENT OF INDEPENDENT AUDITORS
The Board of Directors
Unigene Laboratories, Inc.:
We consent to the incorporation by reference in this Registration Statement on
Form S-3 of Unigene Laboratories, Inc. of our report dated March 22, 1996,
relating to the balance sheets of Unigene Laboratories, Inc. as of December 31,
1995 and 1994 and the related statements of operations, stockholders' equity,
and cash flows for each of the years in the three-year period ended December 31,
1995 which report appears in the December 31, 1995 annual report on Form 10-K of
Unigene Laboratories, Inc. which is incorporated herein by reference and to the
reference to our firm under the heading "Experts" in the Prospectus.
Our report dated March 22, 1996 contains an explanatory paragraph that states
that the Company has suffered recurring losses from operations and has a net
working capital deficiency, which raise substantial doubt about its ability to
continue as a going concern. The financial statements do not include any
adjustment that might result from the outcome of this uncertainty.
KPMG PEAT MARWICK LLP
New York, New York
June 28, 1996
