FORM 10-Q/A
AMENDMENT NO. 1
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2000
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 0-26372
CELLEGY PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
California 82-0429727
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification Number)
349 Oyster Point Boulevard, Suite 200, South San Francisco, California 94080
(Address of principal executive offices, including zip code)
(650) 616-2200
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Sections 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes X No
----- -----
The number of shares outstanding of the registrant's common stock at July 31,
2000 was 12,255,864.
<PAGE>
CELLEGY PHARMACEUTICALS, INC.
INDEX TO FORM 10-Q/A
Page
----
PART I FINANCIAL INFORMATION
Item 1. Financial Statements ( Unaudited )
Consolidated Balance Sheets as of June 30, 2000 and
December 31, 1999 ............................................... 3
Consolidated Statements of Operations for three and six
months ended June 30, 2000 and 1999, and the period from
June 26, 1989 (inception) through June 30, 2000 ................. 4
Consolidated Statements of Cash Flows for the six months
ended June 30, 2000 and 1999, and the period from June 26,
1989 (inception) through June 30, 2000 .......................... 5
Notes to Consolidated Financial Statements ...................... 6
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations........................................ 7
Item 3. Quantitative and Qualitative Disclosure of Market Risk........... 10
Signature(s) ............................................................... 11
*** Financial information is being refiled with this amendment to correct a
transposition of the "short-term investments" figures in June 30, 2000 and
December 31, 1999, on the balance sheet as originally filed.
<PAGE>
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
<TABLE>
Cellegy Pharmaceuticals, Inc.
(a development stage company)
Consolidated Balance Sheets
(Amounts in thousands)
<CAPTION>
June 30, 2000 December 31, 1999
------------- -----------------
(Unaudited) ( Note 1 )
<S> <C> <C>
Assets
Current assets:
Cash and cash equivalents .................................................. $ 433 $ 804
Short-term investments ..................................................... 10,284 10,971
Prepaid expenses and other current assets .................................. 956 1,026
-------- --------
Total current assets ............................................................ 11,673 12,801
Long-term investments ........................................................... 989 4,963
Property and equipment, net ..................................................... 2,951 3,149
Intangible assets related to acquisition, net of accumulated amortization ....... 1,800 --
-------- --------
Total assets .................................................................... $ 17,413 $ 20,913
======== ========
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable and accrued liabilities ................................... $ 458 $ 475
Accrued research fees ...................................................... 540 239
Accrued compensation and related expenses .................................. 119 106
Current portion of note payable ............................................ 1,013 1,153
-------- --------
Total current liabilities ....................................................... 2,130 1,973
Long-term portion of note payable ............................................... 2,045 2,882
Other long-term liabilities ..................................................... 283 219
Shareholders' equity:
Common stock, no par value; 20,000,000 shares authorized: 12,249,264 shares
issued and outstanding at June 30, 2000 and 12,010,242 shares issued and
outstanding at December 31, 1999 ....................................... 57,077 55,368
Accumulated other comprehensive income/(loss) .............................. (23) (35)
Deficit accumulated during the development stage ........................... (44,099) (39,494)
-------- --------
Total shareholders' equity ................................................. 12,955 15,839
-------- --------
Total liabilities and shareholders' equity ...................................... $ 17,413 $ 20,913
======== ========
<FN>
The accompanying notes are an integral part of these consolidated financial statements.
</FN>
</TABLE>
3
<PAGE>
Cellegy Pharmaceuticals, Inc.
(a development stage company)
<TABLE>
Consolidated Statements of Operations
(Unaudited)
(Amounts in thousands, except per share amounts)
<CAPTION>
Period from
June 26, 1989
(inception)
Three Months Ended Six Months Ended through
June 30, June 30, June 30,
2000 1999 2000 1999 2000
-------- -------- -------- -------- --------
<S> <C> <C> <C> <C> <C>
Revenues:
Licensing, milestone, and development
funding .......................... $ -- $ -- $ -- $ 42 $ 2,697
Government grants .................... 20 -- 72 -- 502
Product sales ........................ 112 394 590 712 1,946
-------- -------- -------- -------- --------
Total revenues ............................ 132 394 662 754 5,145
Operating expenses:
Cost of product sales ................ 31 99 136 194 519
Research and development ............. 2,293 1,966 4,153 4,290 31,695
General and administrative ........... 672 686 1,218 1,413 14,106
Acquired in-process technology ....... -- -- -- -- 3,843
-------- -------- -------- -------- --------
Total costs and expenses .................. 2,996 2,751 5,507 5,897 50,163
-------- -------- -------- --------
Operating loss ............................ (2,864) (2,357) (4,845) (5,143) (45,018)
Interest income (expense),
and other income, net ............... 174 77 240 193 2,368
-------- -------- -------- -------- --------
Net loss .................................. (2,690) (2,280) (4,605) (4,950) (42,650)
Non-cash preferred dividends .............. -- -- -- -- 1,449
-------- -------- -------- -------- --------
Net loss applicable to common shareholders $ (2,690) $ (2,280) $ (4,605) $ (4,950) $(44,099)
======== ======== ======== ======== ========
Basic and diluted net loss per common share $ (0.22) $ (0.22) $ (0.38) $ (0.49)
======== ======== ======== ========
Weighted average common shares outstanding 12,110 10,176 12,072 10,175
======== ======== ======== ========
<FN>
The accompanying notes are an integral part of these consolidated financial statements.
</FN>
</TABLE>
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<PAGE>
Cellegy Pharmaceuticals, Inc.
(a development stage company)
<TABLE>
Consolidated Statements of Cash Flows
(Unaudited)
(Amounts in thousands)
<CAPTION>
Period from
June 26, 1989
(inception)
Six Months Ended June 30, through
-------------------------- June 30,
2000 1999 2000
-------- -------- -----------
<S> <C> <C> <C>
Operating activities
Net cash used in operating activities ........................ $ (4,080) $ (5,107) $(36,606)
Investing activities
Purchase of property and equipment ........................... (38) (703) (3,791)
Purchases of investments ..................................... -- (1,500) (60,525)
Sales and maturities of investments .......................... 4,661 6,565 49,218
Purchase of Quay, net of cash acquired ....................... (368) -- (368)
-------- -------- --------
Net cash provided by (used in) investing activities .......... 4,255 4,362 (15,466)
Financing activities
Proceeds from notes payable .................................. $ -- $ 1,280 $ 8,047
Repayment of notes payable ................................... (806) -- (3,382)
Other long-term liabilities .................................. -- 31 219
Net proceeds from issuance of common stock ................... 260 1 35,943
Issuance of convertible preferred stock, net of issuance costs -- -- 11,758
Deferred financing costs ..................................... -- -- (80)
-------- -------- --------
Net cash provided by financing activities .................... (546) 1,312 52,505
-------- -------- --------
Net increase (decrease) in cash and cash equivalents ......... (371) 567 433
Cash and cash equivalents, beginning of period ............... $ 804 $ 1,611 $ --
-------- -------- --------
Cash and cash equivalents, end of period ..................... $ 433 $ 2,178 $ 433
======== ======== ========
<FN>
The accompanying notes are an integral part of these consolidated financial statements.
</FN>
</TABLE>
5
<PAGE>
Cellegy Pharmaceuticals, Inc.
(a development stage company)
Notes to Consolidated Financial Statements
Note 1. - Basis of Presentation
The accompanying interim consolidated financial statements have been
prepared by Cellegy in accordance with generally accepted accounting principles
for interim financial information and with the instructions to Form 10-Q and
Article 10 of Regulation S-X. Accordingly, they do not include all of the
information and footnote disclosures required by generally accepted accounting
principles for complete financial statements. In the opinion of management, the
accompanying consolidated financial statements include all adjustments
(consisting of only normal recurring adjustments) considered necessary for a
fair presentation of operating results for the six and three months ended June
30, 2000 and may not necessarily be indicative of the results to be expected for
any other interim period or for the full year.
The balance sheet at December 31, 1999 has been derived from the
audited financial statements at that date but does not include all of the
information and footnotes required by generally accepted accounting principles
for complete financial statements.
For further information, refer to the financial statements and
footnotes thereto included in Cellegy's Annual Report on Form 10-K for the year
ended December 31, 1999.
Note 2. - Principles of Consolidation
Our consolidated financial statements include the accounts of Cellegy
Australia Pty Ltd ("Cellegy Australia") from June 14, 2000, the date of
acquisition, which are immaterial.
Note 3. - Basic and Diluted Net Loss per Share
The financial statements are presented in accordance with Statement of
Financial Accounting Standards No. 128, "Earnings per Share." Basic net loss per
common share is computed using the weighted average number of common shares
outstanding during the period. Diluted earnings per share incorporate the
incremental shares issued upon the assumed exercise of stock options and
warrants, when dilutive. There is no difference between basic and diluted net
loss per share, as presented in the statement of operations, because all options
and warrants are anti-dilutive.
Note 4. - Comprehensive Income
Accumulated other comprehensive income (loss) presented on the
accompanying balance sheet consists of the accumulated net unrealized gain
(loss) on available-for-sale investments. It has no impact on net loss or on
stockholder's equity. Total comprehensive loss for six months ended June 30,
2000 was $4,617,000 compared with $4,994,000 for the same six months ended June
30, 1999. Total comprehensive loss for three months ended June 30, 2000 and June
30, 1999 was $2,693,000 and $2,353,000, respectively.
Note 5. - Segment Reporting
Cellegy has two business segments: pharmaceuticals and cosmeceuticals.
Pharmaceuticals include primarily research and development expenses for
potential prescription products to be marketed directly by us or through
corporate partners.
The cosmeceutical business segment primarily includes development
expenses for non-prescription skin care products. Using related technologies,
Cellegy is currently incurring development expenses and receiving all of
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<PAGE>
its product sales from one customer, Gryphon Development, Inc., which is selling
products exclusively in the United States through a major specialty store chain.
The following table contains information (amount in thousands)
regarding revenues and loss from operating each business segment for the three
months ended June 30, 2000 and 1999.
Three months ended June 30, Six months ended June 30,
2000 1999 2000 1999
Revenues:
Pharmaceuticals $ 32 $ -- $ 84 $ 42
Cosmeceuticals 100 394 578 712
------- ------- ------- -------
$ 132 $ 394 $ 662 $ 754
======= ======= ======= =======
Loss from Operations:
Pharmaceuticals $ (2914) $(2,536) $(5,191) $(5,295)
Cosmeceuticals 50 179 346 152
------- ------- ------- -------
$(2,864) $(2,357) $(4,845) $(5,143)
======= ======= ======= =======
================================================================================
Note 6. - Acquisition Activity
In June 2000, we acquired all assets of the Australian company, Quay
Pharmaceuticals Pty Ltd ("Quay"), an Australian pharmaceutical company producing
Rectogesic(TM), a drug similar to Anogesic. The acquired assets consisted of the
company's inventory, other tangible assets, and purchased technology. The
aggregate value of the 169,224 shares of our unregistered common stock paid to
Quay with an estimated value of $977,000, the 171,146 warrants to purchase
common stock with an estimated value of $484,000, and cash payments of $369,000
were allocated to the tangible assets, purchased technology, and goodwill based
on their estimated fair values on the acquisition date. The recorded intangible
assets will be amortized over three to ten years.
Note 7. - Intangible Assets
Intangible assets, including purchased technology associated with the
Quay acquisition, are stated at cost and amortized on a straight-line basis over
their estimated useful lives of three years. Goodwill, which represents the
excess of acquisition cost over the net assets acquired, is being amortized on a
straight-line basis over ten years. As of June 30, 2000 accumulated amortization
was $30,000.
Item 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations
This Quarterly Report on Form 10-Q includes forward-looking statements.
Words such as "believes," "anticipates," "expects," "intends" and similar
expressions are intended to identify forward-looking statements, but are not the
exclusive means of identifying such statements. These statements concern matters
that involve risks and uncertainties that could cause actual results to differ
materially from those in the forward-looking statements. Further, we undertake
no obligation to revise any statements in order to reflect events or
circumstances that may arise after the date of this report. Actual events or
results may differ materially from those discussed in this Quarterly Report.
Cellegy Pharmaceuticals, Inc., a specialty biopharmaceutical company
incorporated in California in 1989, is engaged in the development of
prescription drugs and high performance skin care products. We are developing
several prescription drugs, including Anogesic(R), a nitroglycerin-based product
for the treatment of anal fissures and hemorrhoids and two transdermal
testosterone gel products, Tostrex(TM), for the treatment of male hypogonadism,
a
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condition that affects men, generally above the age of forty, and Tostrelle(TM),
for the treatment of diminished sexual energy in menopausal women. We have
developed a line of anti-wrinkling cosmeceutical products which we believe will
address the skin care needs of an aging population.
General
In December 1997, we completed an asset purchase agreement with Neptune
Pharmaceutical Corporation ("Neptune") to acquire patent and other intellectual
property rights relating to Anogesic. Our expenses relating to Anogesic product
development and clinical trials are expected to increase during the remainder of
2000 as a result of a second Phase III clinical trial initiated in the first
quarter 2000 for pain reduction in chronic anal fissures and two Phase II trials
for the treatment of hemorrhoids.
In September 1998, we began initial shipments and product sales of our
Intensive Moisturizing formulation to Gryphon Development Inc. ("Gryphon"), the
product development arm of a major specialty retailer. This formulation is a key
ingredient in a line of healing hand creams sold at the specialty retailer's
chain of stores in the United States.
In July 1999, we completed a $10.1 million private placement of 1.6 million
shares of common stock. Participants in the offering included three
institutional investors and our President and Chief Executive Officer.
In October 1999, Cellegy and Glaxo Welcome ("Glaxo") terminated a license
agreement with the return to us of all Glylorin(TM) product rights and with no
further financial obligations by either party. We do not currently intend to
develop Glylorin on our own, but will seek an appropriate partner for certain
geographic territories to develop the product in exchange for possible contract
payments and royalties on future sales.
In March 2000, Cellegy terminated the License Agreement with the Regents of
the University of California ("Regents") for Optimal Lipid Formulations
("Invention"). Cellegy has no further interest in the Invention and is
re-assigning its rights to the Invention to the Regents. Cellegy believes that
the termination of the license will have no material impact.
On June 14, 2000, Cellegy acquired all the assets of Quay Pharmaceuticals
Pty Ltd, an Australian company producing Rectogesic(TM) (nitroglycerin
ointment), a product similar to Anogesic, for a combination of Cellegy stock,
warrants and cash. The operations in Australia are incorporated in a wholly
owned subsidiary, Cellegy Australia Pty Ltd. The amortization of technology and
goodwill associated with the acquisition was $30,000 for the second quarter and
will be approximately $103,000 per quarter for the next two quarters.
Results of Operations
Revenues. Cellegy had revenues of $662,000 and $754,000 for the six months
ended June 30, 2000 and 1999, respectively. During the six months ended June 30,
2000, revenues consisted of $578,000 in product sales to Gryphon Development
("Gryphon") , the development subsidiary of a specialty retailer, $12,000 in
Rectogesic sales, and $72,000 in development funding associated with a Small
Business Innovation Research ("SBIR") grant from the National Institutes of
Health. During the first six months of 1999, revenues consisted of $712,000 in
product sales to Gryphon and $42,000 for development funding associated with the
Glaxo license agreement.
Cellegy had revenues of $132,000 and $394,000 for the three months ended
June 30, 2000 and 1999, respectively. During the three months ended June 30,
2000, revenues consisted of $112,000 in product sales to Gryphon and to various
distributors in Australia, and $20,000 in development funding associated with
the SBIR grant. During the three months ended June 30, 1999, revenues of
$394,000 consisted exclusively of product sales to Gryphon. Based on purchase
orders received, product sales from Gryphon are expected to be approximately
$400,000 during the third quarter of 2000. No orders have yet been received for
the fourth quarter of 2000.
Research and Development Expenses. Research and development expenses were
$4,153,000 for the six months ended June 30, 2000, compared with $4,290,000 for
the same period last year. During the three months ended June
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30, 2000 and 1999, research and development spending was $2,293,000 and
$1,966,000, respectively. Higher expenses for the second quarter of 2000 were
due primarily to costs associated with Cellegy's Phase III clinical trial
studying Anogesic for the treatment of anal fissures. Research expenses are
expected to increase during the remainder of 2000 due primarily to peak activity
associated with the Anogesic Phase III clinical trial, Phase II trials with
Anogesic for the treatment of hemorrhoids and pain following hemorrhoidectomy
surgery, as well as testosterone gel clinical studies for both men and women.
General and Administrative Expenses. General and administrative expenses
were $1,218,000 for the six months ended June 30, 2000, compared with $1,413,000
for the same period last year. We incurred general and administrative expenses
of $672,000 and $686,000 for the three months ended June 30, 2000 and 1999,
respectively. The decreases for both periods in 2000 were primarily due to
one-time staffing and relocation expenses, as well as higher lease expenses in
1999 associated with our new facility. General and administrative expenses are
expected to increase in the future resulting from our corporate development
programs and in support of marketing and promotional programs for Rectogesic in
Australia.
Interest Income (Expense), and Other Income, Net. Cellegy earned net
interest income of $240,000 and $193,000 for the six months ended June 30, 2000
and 1999, respectively. For the three months ended June 30, 2000 and 1999, we
earned net interest income of $174,000 and $77,000, respectively.
Net Loss. The net loss applicable to common shareholders was $4,605,000 or
$0.38 per share for the six months ended June 30, 2000 based on 12,072,000
weighted average shares outstanding, compared with a net loss of $4,950,000 or
$0.49 per share for the six months ended June 30, 1999 based on 10,175,000
weighted average shares outstanding. For the three months ended June 30, 2000,
the net loss applicable to common shareholders was $2,690,000 or $0.22 per share
based on 12,110,000 average shares outstanding compared with a net loss
applicable to common shareholders of $2,280,000 or $0.22 per share during the
same period in 1999 when 10,176,000 weighted average shares were outstanding.
Liquidity and Capital Resources
Cellegy has experienced net losses and negative cash flow from operations
each year since its inception. Through June 30, 2000, we have incurred an
accumulated deficit of $44.1 million and have consumed cash from operations of
$36.6 million. Our equity financing included $6.4 million in net proceeds from
our initial public offering in August 1995, $6.8 million in net proceeds from a
preferred stock financing in April 1996, $3.8 million in net proceeds from a
private placement of common stock in July 1997, $13.8 million in net proceeds
from a secondary public offering of common stock in November 1997 and $10.0
million in net proceeds from a private placement of common stock in July 1999.
Our cash and investments were $11.7 million at June 30, 2000, compared with
$16.7 million at December 31, 1999. The decrease in cash and investments was
principally due to net cash used in operating activities.
Cellegy's operations have and will continue to use substantial amounts of
cash. We have no current source of significant ongoing revenues or capital
beyond existing cash and investments, current product sales to Gryphon
Development and revenues from Cellegy Australia. We have an existing $5.0
million credit line with our bank with a current available balance of $2.0
million. In order to complete the research and development and other activities
necessary to commercialize our products, additional financing will be required.
Our future expenditures and capital requirements depend on numerous factors
including, without limitation, the progress and focus of our research and
development programs, the progress and results of pre-clinical and clinical
testing, 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 to our existing research relationships, our ability to
establish collaborative arrangements, the initiation of commercialization
activities, the purchase of capital equipment and the availability of other
financing.
In the course of our development activities, we have incurred significant
losses and expect to incur substantial additional development costs. As a
result, we 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.
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There is no assurance that such funding will be available for us to finance our
operations on acceptable terms, if at all. Insufficient funding may require us
to delay, reduce or eliminate some or all of our research and development
activities, planned clinical trials and administrative programs. We believe that
available cash resources and the interest thereon will be adequate to satisfy
our capital needs through at least March 31, 2001.
Factors That May Affect Future Operating Results
This Quarterly Report on Form 10-Q/A contains forward-looking statements
which involve risks and uncertainties, including, but not limited to, statements
concerning the completion of clinical trials, particularly our ongoing Phase III
trials using Anogesic and Tostrex, the timing of planned regulatory filings, the
applicability of drug and cosmetic laws and regulations to Cellegy's products,
the validity of our patent coverage, the issuance of future patents pending or
patents applied for, and the need for additional funds. The factors discussed in
Cellegy's reports filed with the Securities and Exchange Commission, including
our Annual Report on Form 10-K for the year ended December 31, 1999, in
particular under the caption "Factors That May Affect Future Operating Results,"
should be carefully considered when evaluating our business and prospects.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We invest our excess cash in short-term, investment grade, fixed income
securities under an investment policy. All of our investments are classified as
available-for-sale. Over 90% of our securities will mature by the end of 2000.
We believe that potential near-term losses in future earnings, fair values or
cash flows related to their investment portfolio would not be significant.
Cellegy has a long-term note payable outstanding with an interest rate that
currently varies with the lender's prime rate.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
CELLEGY PHARMACEUTICALS, INC.
Date: August 9, 2000 /s/ A. Richard Juelis
--------------------------------------
A. Richard Juelis
Vice President, Finance and
Chief Financial Officer
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