-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, GEbbZsADtAs12AeFoyROmWwqL6TXG3BDvy0hj+yk2yUgcFLIzYNrptx16wJgfqZF eAeXoxjRD1remHb3nsI4Ag== 0000891618-97-004372.txt : 19971107 0000891618-97-004372.hdr.sgml : 19971107 ACCESSION NUMBER: 0000891618-97-004372 CONFORMED SUBMISSION TYPE: S-1/A PUBLIC DOCUMENT COUNT: 4 FILED AS OF DATE: 19971106 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: CELLEGY PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000887247 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 820429727 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: S-1/A SEC ACT: SEC FILE NUMBER: 333-38179 FILM NUMBER: 97708652 BUSINESS ADDRESS: STREET 1: 1065 E HILLSDALE BLVD STREET 2: SUITE 418 CITY: FORSTER CITY STATE: CA ZIP: 94404 BUSINESS PHONE: 4153826770 MAIL ADDRESS: STREET 1: 1065 E HILLSDALE BLVD STREET 2: SUITE 418 CITY: FORSTER CITY STATE: CA ZIP: 94404 S-1/A 1 AMENDMENT NO. 1 TO FORM S-1 1 AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON NOVEMBER 5, 1997 REGISTRATION NO. 333-38179 ================================================================================ SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ------------------------ AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ------------------------ CELLEGY PHARMACEUTICALS, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER) CALIFORNIA 2834 82-0429727 (STATE OR OTHER JURISDICTION OF (PRIMARY STANDARD INDUSTRIAL (I.R.S. EMPLOYER IDENTIFICATION INCORPORATION OR ORGANIZATION) CLASSIFICATION CODE NUMBER) NO.)
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: 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
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 - -------------------------------------------------------------------------------- - ------------------------------------------------------------------------------------------------------------ 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(3) - ------------------------------------------------------------------------------------------------------------ Common Stock, no par value per share................. 2,587,500 shares $8.625 $22,317,188 $6,763 ============================================================================================================
(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. (3) Previously paid. 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. ================================================================================ 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 NOVEMBER 5, 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 November 4, 1997, the last reported sale price of the Common Stock was $7.375 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 7. ------------------------ 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.
================================================================================================= PRICE TO PROCEEDS TO PUBLIC UNDERWRITING COMPANY(2) DISCOUNT(1) - ------------------------------------------------------------------------------------------------- Per Share......................... $ $ $ Total(3).......................... $ $ $ ============================================================================================
(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 four years commencing one year following the closing of this Offering, 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. 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" and "Recent Developments." - --------------------------------------------------------------------------------
DEVELOPMENT TECHNOLOGIES PRODUCTS INDICATIONS STATUS UTILIZED ------------------------ ------------------------ ------------------------ ------------ PRESCRIPTION TOPICAL THERAPEUTICS Glylorin Non-bullous congenital Phase III trials in Proprietary ichthyosiform progress erythroderma Ichthyosis vulgaris Phase II trials planned Proprietary Anogesic* Anal fissures Phase III trials planned CELLEDIRM Hemorrhoids Phase III trials planned CELLEDIRM 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 Photodamaged and aging In human testing CELLEDIRM products** 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
- -------------------------------------------------------------------------------- * The Company has signed a legally binding letter of intent to acquire the Anogesic product. See "Recent Developments." ** 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 that, 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." 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 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. RECENT DEVELOPMENTS On November 3, 1997, the Company signed a legally binding letter of intent (the "Anogesic Agreement") with Neptune Pharmaceutical Corporation ("Neptune") to acquire all patent and other intellectual property rights relating to "Anogesic" (the "Anogesic Acquisition"), a topical product candidate for the treatment of anal fissures and hemorrhoids. Unlike currently available drugs, which provide only partial symptomatic relief, based on clinical studies to date Anogesic appears to heal anal fissures and hemorrhoids. As a result, Anogesic represents a potential alternative to surgical intervention. Clinical studies of Anogesic have been completed on over 400 patients to date, and the Company plans to commence Phase III trials during 1998. The closing of the Anogesic Acquisition is subject to the satisfaction of certain conditions, and there can be no assurance that the Company will conclude the Anogesic Acquisition. See "Recent Developments." 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 6 THE OFFERING 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)
SUMMARY FINANCIAL INFORMATION (IN THOUSANDS, EXCEPT PER SHARE DATA)
NINE MONTHS ENDED YEARS ENDED DECEMBER 31, SEPTEMBER 30, --------------------------- ----------------- 1994 1995 1996 1996 1997 ------- ------- ------- ------- ------- 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
SEPTEMBER 30, 1997 -------------------------- ACTUAL AS ADJUSTED(4) ------- -------------- BALANCE SHEET DATA: Cash, cash equivalents and investments............................... $ 9,377 $ 24,509 Total assets......................................................... 9,841 24,973 Long-term obligations................................................ -- -- Deficit accumulated during the development stage..................... (17,431) (17,431) Total shareholders' equity........................................... 9,114 24,246
- --------------- (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 shares of Common Stock issuable upon the exercise of other outstanding warrants at a weighted average exercise price of $7.79 per share, up to 125,000 shares of Common Stock issuable upon exercise of the Underwriter Warrant, 33,057 shares of Common Stock that were issued in connection with the Anogesic Acquisition and 429,752 shares of Common Stock that are issuable at the closing of the Anogesic Acquisition. See "Description of Capital Stock" and "Recent Developments." (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 $7.375 per share. See "Use of Proceeds" and "Capitalization." 5 7 RECENT DEVELOPMENTS On November 3, 1997, the Company signed the Anogesic Agreement with Neptune to acquire all patent and other intellectual property rights relating to "Anogesic," a topical product candidate for the treatment of anal fissures and hemorrhoids, and certain other related intellectual property of Neptune. Unlike currently available drugs, which provide only partial symptomatic relief, based on clinical studies to date Anogesic appears to heal anal fissures and hemorrhoids. As a result, Anogesic represents a potential alternative to surgical intervention. Clinical studies of Anogesic have been completed on over 400 patients to date, and the Company plans to commence Phase III trials during 1998. Anal fissures are painful tears or slits in the tissue of the anus and are common conditions affecting men and women of all age groups. Of the approximately 200,000 new cases of anal fissures each year, more than half require painful and expensive surgical intervention to treat these conditions. A thrombosed external hemorrhoid is a dilated, swollen vein at the margin of the anus, resulting from clotting blood formed within the dilated external hemorrhoidal veins. In the United States alone, approximately nine million patients seek treatment from physicians for hemorrhoids each year, and the Company believes that a significant number of additional people suffering from this condition do not seek medical treatment. Current drug therapies include anesthetics and anti-inflammatory agents that only partially relieve the symptoms of the conditions. Even though current treatments are only partially effective, sales of products currently used to treat anal fissures and hemorrhoids are estimated to be more than $500 million in the United States, Europe and Japan. Surgical procedures represent substantial additional expenditures related to these conditions. The patented Anogesic product will be administered intra-anally in a proprietary formulation that includes nitroglycerin, a drug that has been used for many years in the treatment of certain heart diseases. Once administered, nitroglycerin results in relaxation of the sphincter muscles, which rapidly relieves pain and promotes the healing of the anal fissure or hemorrhoid. Anogesic will incorporate the Company's proprietary CELLEDIRM technology to assist in mitigating the inflammation present in these conditions. Clinical studies published in the New England Journal of Medicine and The Lancet have shown that nitroglycerin promotes healing and is capable of rapidly relieving intense anal pain. In the study published in The Lancet, 80 patients with anal fissures were randomized to receive treatments with topical 0.2 percent nitroglycerin ointment or placebo. After eight weeks, healing was observed in 26 out of 38 (68%) of the patients treated with nitroglycerin and in 3 out of 39 (8%) of the patients treated with placebo (p < 0.0001). The Company issued 33,057 shares of Common Stock to Neptune upon signing the Anogesic Agreement. At the closing, the Company will deliver to Neptune an additional 429,752 shares of Common Stock. In addition, the Anogesic Agreement calls for a series of additional payments, aggregating up to $5.5 million and payable in shares of Common Stock. The additional payments are subject to successful completion of certain late stage clinical trials and regulatory milestones which, if achieved, would occur over the next several years. An additional payment of $5 million, also payable in shares of Common Stock, will be made if in the future the Company applies for and receives FDA approval for the sale of Anogesic in the over-the-counter (non-prescription) market for the treatment of hemorrhoids. The Anogesic Agreement does not provide for the payment by Cellegy of any future product royalties in connection with sales of Anogesic. The Company currently expects to conclude the Anogesic Acquisition by December 31, 1997. The Anogesic Agreement includes several representations, warranties and covenants of Neptune and Cellegy, indemnification of the Company by Neptune and its shareholders for, among other things, breaches of Neptune's representations, warranties and covenants, and indemnification of Neptune and its shareholders by Cellegy for breaches of Cellegy's representations, warranties and covenants or claims based solely on Cellegy's conduct after the closing date. The closing of the Anogesic Acquisition is subject to a number of closing conditions, including the satisfactory completion of Cellegy's due diligence of Neptune, the absence of material adverse changes in Neptune's or Cellegy's business between the date of the Anogesic Agreement and the closing date, the approval of the transaction by Neptune's shareholders and the absence of litigation or claims relating to the transaction or Anogesic. There can be no assurance that the Company will complete the Anogesic Acquisition. Failure to complete the Anogesic Acquisition may have a material adverse effect on the market price of the Common Stock but would not, the Company believes, have a material adverse effect on its business or financial condition. 6 8 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 and the planned Phase III clinical trials relating to Anogesic. 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 7 9 for Glylorin, that the FDA will approve Glylorin for marketing or that current or future clinical trials of any of the Company's other product candidates, including Anogesic, 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 8 10 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 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 9 11 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. 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 Drug 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 increased product 10 12 liability exposure. Sales of the Company's products outside the United States will be subject to regulatory 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. 11 13 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 12 14 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. 13 15 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 $15.1 million (approximately $17.5 million if the Underwriter's over-allotment option is exercised in full), at an assumed public offering price of $7.375 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. Other than the Anogesic Agreement, 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.
1995 HIGH LOW - ----------------------------------------------------------------------------- ----- ----- 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 November 4, 1997).................................... 9.44 6.31
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. 14 16 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 $7.375 per share, and the receipt of the estimated net proceeds therefrom.
SEPTEMBER 30, 1997 ------------------------ ACTUAL AS ADJUSTED -------- ----------- (IN THOUSANDS) 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 41,629 Unrealized gain on investments...................................... 48 48 Deficit accumulated during the development stage.................... (17,431) (17,431) -------- -------- Total shareholders' equity..................................... 9,114 26,246 -------- -------- Total capitalization........................................ $ 9,114 $ 24,246 ======== ========
- --------------- (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 shares of Common Stock issuable upon the exercise of other outstanding warrants at a weighted average exercise price of $7.79 per share, up to 125,000 shares of Common Stock issuable upon exercise of the Underwriter Warrant, 33,057 shares of Common Stock that were issued in connection with the Anogesic Acquisition and 429,752 shares of Common Stock that are issuable at the closing of the Anogesic Acquisition. See "Description of Capital Stock" and "Recent Developments." 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. 15 17 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 $24,246,000, or $2.46 per share of Common Stock. This represents an immediate increase in pro forma net tangible book value of $1.26 per share to existing holders of Common Stock and an immediate dilution per share of $4.91 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. Public offering price per share(1).......................... $7.375 Pro forma net tangible book value per share before offering............................................... $1.20 Increase per share attributable to new investors.......... 1.26 ----- Pro forma net tangible book value per share after offering.................................................. 2.46 ------ 4.91 Dilution per share to new investors............... ======
- --------------- (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 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. 16 18 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.
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) 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
DECEMBER 31, ----------------------------------------------- SEPTEMBER 30, 1992 1993 1994 1995 1996 1997 ------- ------- ------- ------- ------- ------------- (IN THOUSANDS) 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
- --------------- (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. 17 19 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," "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. 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. On November 3, 1997, the Company signed the Anogesic Agreement with Neptune to acquire all patent and other intellectual property rights relating to Anogesic, a topical product candidate for the treatment of anal fissures and hemorrhoids. The closing of the Anogesic Acquisition is subject to the satisfaction or waiver of certain conditions, and there can be no assurance that the Company will conclude the Anogesic Acquisition. See "Recent Developments." If the Company completes the Anogesic Acquisition, the Company's expenses relating to product development and clinical trials are expected to increase during 1998 and thereafter as a result of expenses relating to Anogesic. The Company expects to record a material charge to operations for in-process technology upon completion of the Anogesic Acquisition. 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 18 20 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. 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 19 21 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 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 20 22 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. 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. 21 23 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. RECENT DEVELOPMENTS On November 3, 1997, the Company signed the Anogesic Agreement with Neptune to acquire all patent and other intellectual property rights relating to Anogesic, a topical product candidate for the treatment of anal fissures and hemorrhoids. Unlike currently available drugs which provide only partial symptomatic relief, based on clinical studies to date Anogesic appears to heal anal fissures and hemorrhoids. As a result, Anogesic represents a potential alternative to surgical intervention. Clinical studies of Anogesic have been completed on over 400 patients to date, and the Company plans to commence Phase III trials during 1998. The closing of the Anogesic Acquisition is subject to the satisfaction or waiver of certain conditions, and there can be no assurance that the Company will conclude the Anogesic Acquisition. See "Recent Developments." 22 24 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 (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. 23 25 (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. 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 24 26 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.
INCIDENCE OF ADVERSE TRANSDERMAL DRUG SKIN REACTIONS* PRINCIPAL SKIN REACTIONS - ---------------- -------------------- --------------------------------- 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
- --------------- * Ranges reflect differing results achieved when more than one study was conducted. 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 25 27 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 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. 26 28 PRODUCTS UNDER DEVELOPMENT The following table summarizes certain information concerning Cellegy's clinical and preclinical prescription product candidates.
PROPRIETARY DEVELOPMENT TECHNOLOGIES PRODUCTS INDICATIONS STATUS UTILIZED - ----------------------- ----------------------- ----------------------- ------------ 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
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 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 27 29 (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 (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 28 30 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 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 29 31 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. The following table summarizes certain information concerning Cellegy's cosmeceutical product candidates.
DEVELOPMENT TECHNOLOGIES PRODUCTS INDICATIONS STATUS UTILIZED - ----------------------- ----------------------- ----------------------- ------------ 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
- --------------- * 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 that, 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 30 32 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. 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. 31 33 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 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 32 34 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 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 pursuant to which the Company has exclusive license rights to certain barrier repair and drug delivery and other technology contain certain development and 33 35 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 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 34 36 material adverse effect on the Company. If the Company fails to comply with applicable regulatory requirements for marketing drugs, or if the Company's cosmeceutical products are deemed to be drugs by the FDA, the Company could be subject 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 the 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 practice ("GCP") requirements 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 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 35 37 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. 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 36 38 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 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 37 39 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 requirements (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 cGMP 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 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 38 40 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. 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 39 41 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. 40 42 MANAGEMENT The executive officers, directors, and other significant employees of the Company are as follows:
NAME AGE POSITION - ----------------------------- --- --------------------------------------------------- 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
- --------------- (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. 41 43 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 42 44 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 43 45 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. 44 46 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 $100,000 (together, the "Named Officers"). SUMMARY COMPENSATION TABLE
LONG TERM ANNUAL COMPENSATION COMPENSATION -------------------------------------------- SECURITIES OTHER ANNUAL UNDERLYING ALL OTHER NAME AND PRINCIPAL SALARY BONUS COMPENSATION OPTIONS COMPENSATION POSITION YEAR ($) ($) ($) (#) ($) - --------------------------- ---- ------- ------ ------------ ------------ ------------ 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 -- -- -- -- --
- --------------- (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. 45 47 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
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 - --------------------------------- ----------- -------------------- ----------- ------------------ K. Michael Forrest(1)............ 245,000 47.2% $4.56 November 20, 2006 Carl R. Thornfeldt, M.D.(2)...... 45,000 8.7% $5.64 January 2, 2006 Carl R. Thornfeldt, M.D.......... 9,000 1.7% $4.56 November 20, 2006 Michael L. Francoeur, Ph.D.(3)... 75,000 14.4% $7.25 May 22, 2006 Michael L. Francoeur, Ph.D....... 6,000 1.2% $4.56 November 20, 2006 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
- --------------- (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. 46 48 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
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) - ---------------------------------------------- ------------------------- ----------------------------- 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 --
- --------------- (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, 47 49 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." 48 50 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.
PERCENTAGE OWNERSHIP SHARES ------------------------ NAME OF BENEFICIAL OWNER OR GROUP BENEFICIALLY BEFORE THE AFTER THE AND NATURE OF BENEFICIAL OWNERSHIP OWNED(1) OFFERING OFFERING - ------------------------------------------------------------ ------------ ---------- --------- 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%
- --------------- * 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. 49 51 (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 50 52 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. 51 53 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 an Underwriter Warrant for nominal consideration, entitling the Underwriter to purchase up to 125,000 shares of the Company's Common Stock at a price per share equal to 130% of the public offering price. The Underwriter Warrant is exercisable for a period of four years, commencing one year following the date 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. The Underwriter Warrant is not transferable for a period of one year from the date of this Offering, except as to officers of the Underwriter. The exercise price and the number of shares issuable upon exercise 52 54 may, under certain circumstances, be subject to adjustment pursuant to antidilution provisions. See "Underwriting." 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 53 55 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. See "Underwriting." Pursuant to the Anogesic Agreement, the Company has agreed to register for resale shares of Common Stock that may be issued to Neptune or its shareholders in connection with the Anogesic Acquisition, and to keep such registration effective until such shares are sold or until the shares may be publicly resold without restriction pursuant to Rule 144. 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, 54 56 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 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. 55 57 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, a warrant (the "Underwriter Warrant") to purchase up to 125,000 shares of Common Stock at a price per share equal to 130% of the public offering price. 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. Such demand and piggyback registration rights will expire five years from the date of the Offering. The Underwriter Warrant will be restricted from sale, transfer, assignment or hypothecation for a period of one year from the date of this Offering, except as to officers 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 56 58 securities of the Company) 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 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. 57 59 INDEX TO FINANCIAL STATEMENTS
PAGE ----- 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
F-1 60 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, except for note 10, as to which the date is November 5, 1997 F-2 61 CELLEGY PHARMACEUTICALS, INC. (A DEVELOPMENT-STAGE COMPANY) BALANCE SHEETS ASSETS
DECEMBER 31, SEPTEMBER --------------------------- 30, 1995 1996 1997 ----------- ----------- ----------- (UNAUDITED) 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 -- 2,161,271 -- 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)............................. Common stock, no par value; 20,000,000 shares 13,803,793 20,141,370 26,495,852 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)............ Unrealized gain on investments.................... -- 22,167 48,398 Deficit accumulated during the development (10,155,456) (14,937,317) (17,430,745) stage.......................................... ---------- ---------- ---------- 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 ========== ========== ==========
See accompanying notes. F-3 62 CELLEGY PHARMACEUTICALS, INC. (A DEVELOPMENT-STAGE COMPANY) STATEMENTS OF OPERATIONS
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) 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 =========== =========== =========== =========== ===========
See accompanying notes F-4 63 CELLEGY PHARMACEUTICALS, INC. (A DEVELOPMENT-STAGE COMPANY) STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT)
SERIES A SERIES B SERIES C CONVERTIBLE CONVERTIBLE CONVERTIBLE PREFERRED STOCK PREFERRED STOCK PREFERRED STOCK COMMON STOCK ----------------- ------------------ --------------------- ------------------ SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT ------- ------- ------- -------- -------- ---------- -------- ------- Issuance of common stock for cash through December 31, 1993.......................... -- $ -- -- $ -- -- $ -- 834,893 $81,725 Issuance of common stock for services rendered through December 31, 1993......... -- -- -- -- -- -- 269,116 24,261 Issuance of common stock in connection with merger with Pacific Pharmaceuticals, Inc. in April 1992.............................. -- -- -- -- -- -- 97,062 8,750 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) (324) 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 1,197,485 114,412 Exercise of options to purchase common stock...................................... -- -- -- -- -- -- 964 1,739 Net loss in 1994............................ -- -- -- -- -- -- -- -- ------ ------- ------ -------- ------- ---------- ------- ------- Balance at December 31, 1994................ 702,854 1,421,234 12,750 114,000 477,081 4,978,505 1,198,449 116,151 DEFICIT ACCUMULATED TOTAL UNREALIZED DURING THE SHAREHOLDERS' GAIN ON DEVELOPMENT EQUITY INVESTMENTS STAGE (DEFICIT) ----------- ----------- ------------- < Issuance of common stock for cash through December 31, 1993.......................... $ -- $ -- $ 81,725 Issuance of common stock for services rendered through December 31, 1993......... -- -- 24,261 Issuance of common stock in connection with merger with Pacific Pharmaceuticals, Inc. in April 1992.............................. -- -- 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) 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................ -- (5,460,080) 1,168,071 Exercise of options to purchase common stock...................................... -- -- 1,739 Net loss in 1994............................ -- (2,543,499) (2,543,499) ------- ------- ---------- Balance at December 31, 1994................ -- (8,003,579) (1,373,689)
See accompanying notes. F-5 64 CELLEGY PHARMACEUTICALS, INC. (A DEVELOPMENT-STAGE COMPANY) STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT) (CONTINUED)
SERIES B SERIES C CONVERTIBLE SERIES A CONVERTIBLE CONVERTIBLE COMMON PREFERRED STOCK PREFERRED STOCK PREFERRED STOCK STOCK ----------------------- ----------------- --------------------- ---------- SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT SHARES --------- ----------- ------- -------- --------- ---------- ---------- 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 ======== ========== ======= ======== ========= ========== ========= DEFICIT ACCUMULATED TOTAL UNREALIZED DURING THE SHAREHOLDERS' GAIN ON DEVELOPMENT EQUITY AMOUNT INVESTMENTS STAGE (DEFICIT) ----------- ----------- ------------ ------------- 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 ========== ======= =========== ===========
See accompanying notes F-6 65 CELLEGY PHARMACEUTICALS, INC. (A DEVELOPMENT-STAGE COMPANY) STATEMENTS OF CASH FLOWS
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) 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)
See accompanying notes. F-7 66 CELLEGY PHARMACEUTICALS, INC. (A DEVELOPMENT-STAGE COMPANY) STATEMENTS OF CASH FLOWS (CONTINUED)
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) 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 ============ ============ ============ ============= ============ ============ =============
See accompanying notes. F-8 67 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 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) 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 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) 2. INVESTMENTS At December 31, 1996, investments consist of the following:
UNREALIZED UNREALIZED COST GAINS LOSSES FAIR VALUE ---------- ------- ------- ---------- 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 ========== ======= ======= ==========
The cost and estimated fair market value of investments in debt securities at December 31, 1996, by contractual maturity, were as follows:
FAIR MARKET COST VALUE ---------- ---------- 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 ========== ==========
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:
DECEMBER 31, ---------------------- 1995 1996 -------- --------- 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 ======== ========
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 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) 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: 1997............................................................. $ 331,803 1998............................................................. 238,480 1999............................................................. 243,285 2000............................................................. 198,826 2001............................................................. 77,051 ---------- $1,089,445 ==========
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 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) 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 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) Warrants The Company has the following warrants outstanding to purchase common stock at September 30, 1997:
NUMBER OF EXERCISE PRICE EXPIRATION SHARES PER SHARE DATE ISSUED DATE - ---------- -------------- -------------- ------------------ 35,496 $ 4.51 October 1994.. December 31, 1999 52,768 February $ 0.01 1995.......... December 31, 1999 365,728 February $ 7.81 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 ==========
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 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) Activity under the Plan is summarized as follows:
SHARES UNDER PRICE RANGE WEIGHTED AVERAGE OPTION PER SHARE EXERCISE PRICE ------------ ------------- ---------------- 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 ========
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:
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 - --------------------------------------- -------------- ----------- -------- -------------- -------- $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 ======= =======
F-15 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) 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:
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 - --------------------------------- ------------ ------------ -------- ------------ --------- $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 ====== ======
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 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) 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:
YEARS ENDED DECEMBER 31, ------------------ 1995 1996 ------ ------ 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
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:
1995 1996 ----------- ----------- 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)
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 76 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 77 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:
DECEMBER 31, --------------------------- 1995 1996 ----------- ----------- 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................................... $ -- $ -- =========== ===========
10. SUBSEQUENT EVENT On November 3, 1997, the Company signed a legally binding letter of intent with Neptune Pharmaceutical Corporation ("Neptune"), to acquire all patent and other intellectual property rights relating to "Anogesic" (the "Anogesic Acquisition"), a topical product candidate for the treatment of anal fissures and hemorrhoids. The closing of the Anogesic Acquisition is subject to the satisfaction of certain conditions, and there can be no assurance that the Company will conclude the Anogesic Acquisition. The Company expects to record a material charge to operations for in-process technology upon completion of the Anogesic Acquisition. F-19 78 ====================================================== 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
PAGE ---- Prospectus Summary.................... 3 Recent Developments................... 6 Risk Factors.......................... 7 Use of Proceeds....................... 14 Price Range of Common Stock........... 14 Capitalization........................ 15 Dividend Policy....................... 15 Dilution.............................. 16 Selected Financial Data............... 17 Management's Discussion and Analysis of Financial Condition and Results of Operations....................... 18 Business.............................. 22 Management............................ 41 Certain Transactions.................. 48 Principal Shareholders................ 49 Description of Capital Stock.......... 52 Shares Eligible for Future Sale....... 54 Underwriting.......................... 56 Legal Matters......................... 57 Experts............................... 57 Available Information................. 57 Index to Consolidated Financial Statements.......................... F-1
====================================================== ====================================================== 2,250,000 SHARES LOGO COMMON STOCK ------------------------ PROSPECTUS ------------------------ (LOGO) , 1997 ====================================================== 79 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. 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 ========
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 80 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 81 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. 5. In November 1997, the Company issued 33,057 shares of Common Stock to Neptune Pharmaceutical Corporation pursuant to the Anogesic Agreement, in connection with the proposed acquisition by the Company of the Anogesic product candidate by the Company. The forgoing securities 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. 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.
EXHIBIT NUMBER EXHIBIT TITLE - ------ ----------------------------------------------------------------------------------- 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).*
II-3 82
EXHIBIT NUMBER EXHIBIT TITLE - ------ ----------------------------------------------------------------------------------- 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).* 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).* 10.14 Binding Letter of Intent dated November 3, 1997 between the Company and Neptune Pharmaceutical Corporation. (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). 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).*
- --------------- * Previously filed. ** 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-4 83 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 Amendment No. 1 to the Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Foster City, State of California, on November 5, 1997. CELLEGY PHARMACEUTICALS, INC. By: /s/ K. MICHAEL FORREST ------------------------------------ K. Michael Forrest President and Chief Executive Officer In accordance with the requirements of the Securities Act of 1933, this Amendment No. 1 to the Registration Statement has been signed by the following persons in the capacities and on the dates stated.
NAME TITLE DATE - --------------------------------------------- ----------------------------- ----------------- PRINCIPAL EXECUTIVE OFFICER: /s/ K. MICHAEL FORREST President, Chief Executive November 5, 1997 - --------------------------------------------- Officer and Director K. Michael Forrest PRINCIPAL FINANCIAL OFFICER AND PRINCIPAL ACCOUNTING OFFICER: /s/ A. RICHARD JUELIS Vice President, Finance, November 5, 1997 - --------------------------------------------- Chief Financial Officer and A. Richard Juelis Secretary DIRECTORS: /s/ CARL R. THORNFELDT, M.D.* Chairman of the Board of November 5, 1997 - --------------------------------------------- Directors Carl R. Thornfeldt, M.D. /s/ JACK L. BOWMAN* Director November 5, 1997 - --------------------------------------------- Jack L. Bowman /s/ DENIS R. BURGER, PH.D.* Director November 5, 1997 - --------------------------------------------- Denis R. Burger, Ph.D. /s/ TOBI B. KLAR, M.D.* Director November 5, 1997 - --------------------------------------------- Tobi B. Klar, M.D. /s/ ALAN A. STEIGROD* Director November 5, 1997 - --------------------------------------------- Alan A. Steigrod /s/ LARRY J. WELLS* Director November 5, 1997 - --------------------------------------------- Larry J. Wells *By: /s/ K. MICHAEL FORREST ---------------------------------------- K. Michael Forrest Attorney-in-Fact
II-5 84 EXHIBIT INDEX
EXHIBIT SEQUENTIALLY NUMBER DESCRIPTION OF DOCUMENT NUMBERED PAGE - ------ -------------------------------------------------------------------- ------------- 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).*
85
EXHIBIT SEQUENTIALLY NUMBER DESCRIPTION OF DOCUMENT NUMBERED PAGE - ------ -------------------------------------------------------------------- ------------- 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).* 10.14 Binding Letter of Intent dated November 3, 1997 between the Company and Neptune Pharmaceutical Corporation. (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). 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).*
- --------------- * Previously filed. ** Represents a management contract or compensatory plan or arrangement. EX-4.3 2 FORM OF UNDERWRITER WARRANT 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 the date one year from the date of this Warrant, and before 5:00 P.M., New York time, on the Expiration Date (as defined below), 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. 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 the date five years from the effective date of the Company's S-1 Registration Statement, no. 333-38179, as amended, 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 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 the date one year from the date of this Warrant, 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 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 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 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 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 7 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 8 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, 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 10 11 the date of this Warrant 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 11 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 the date of this Warrant 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. 12 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 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 14 15 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. 15 16 (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. 16 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 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 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 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 EX-10.14 3 BINDING LETTER OF INTENT 1 Exhibit 10.14 Cellegy Pharmaceuticals - Neptune Pharmaceuticals Binding Letter of Intent This binding letter of intent (the "Letter") is dated as of November 3, 1997 and is entered into by and between Cellegy Pharmaceuticals, Inc. ("Cellegy") and Neptune Pharmaceutical Corporation ("Neptune"). BACKGROUND Cellegy desires to acquire all of the intellectual property and certain other assets of Neptune and to undertake development and commercialization of Neptune's product candidate, "Anogesic." Neptune desires to sell all of its assets relating to Anogesic and all other intellectual property of Neptune to Cellegy on terms consistent with those outlined in this agreement. AGREEMENT DEFINITIONS: Acquired Product: U.S. Patent no. _____________, which relates in part to Neptune's nitroglycerin product candidate currently named "Anogesic," for the treatment of anal fissures, hemorrhoids, and all other conditions. Acquired Assets : The Acquired Product and any Intellectual Property Field : All uses, prescription and non prescription Territory : Worldwide Intellectual Property: All patents, patent applications, registered and unregistered copyrights, registered and unregistered trademarks, trade names, service marks or service names, licenses or license agreements, clinical and pre-clinical data and information, FDA applications and all other materials relating to FDA or other regulatory matters, know-how, contracts, agreements or other instruments, relating to the Acquired Product, or any other intellectual property of Neptune. Excluded Assets: All accounts receivable and cash of Neptune as of the Closing Date (including prepaid expenses and deposits), all liabilities and 2 obligations of Neptune arising out of the conduct of Neptune's business or the Acquired Assets before the Closing Date, and any other assets that Cellegy designates as Excluded Assets before the Closing Date. Cellegy does not assume and shall not become obligated to pay any liabilities, debts or obligations of Neptune, except for those contractual obligations under agreements assigned to Cellegy that Cellegy agrees to assume. Excluded Assets also includes all leases of real property to which Neptune is a party or is otherwise bound, and Cellegy shall not assume any liabilities or obligations under any such leases. In addition, Neptune will be responsible for any amounts owing to its employees that accrue before the closing and for any amounts owing to employees who do not receive an offer or who do not accept an offer of employment with Cellegy. Transaction: The transactions contemplated by this Letter and the Agreement. This Letter confirms the legally binding agreement of Cellegy and Neptune to enter into a business transaction upon the terms and conditions described herein. The parties intend to enter into a more comprehensive agreement (the "Agreement") incorporating the material terms and conditions described in this Letter. Unless and until the Agreement becomes effective, however, the parties agree to be bound by all of the terms and conditions of this Letter. The parties hereby agree to use their best efforts to negotiate in good faith, as soon as possible, but in any event within 30 days from the effective date hereof, a more comprehensive Agreement on terms consistent in all material respects with the terms set forth in this Letter. If the parties have not executed the agreement by the end of such 30 day period, and such failure is not a result of bad faith on Cellegy's part, then Cellegy may at its option require Neptune to enter into a more comprehensive Agreement containing the terms of this Letter and other customary and reasonable terms for transactions of this type (including indemnification for losses resulting from breaches or inaccuracies of representations and warranties of Neptune). The comprehensive Agreement will contain customary representations of Neptune (including those set forth on Exhibit A attached hereto and other customary matters), customary representations of Cellegy (including those set forth on Exhibit A attached hereto and other customary matters), customary closing conditions, and indemnification provisions, all of which provisions may be more expansive and comprehensive than the representations, warranties and other provisions set forth in this Letter. The parties further agree that this Letter will be binding on both parties, provided that the results of scientific, commercial and intellectual property due diligence to be conducted by Cellegy are satisfactory to Cellegy. Prior to execution of the Agreement, Cellegy will be given the opportunity to fully investigate Neptune's business, technology and financial condition. If the results of such due diligence are not satisfactory to Cellegy, then Cellegy may decline to complete the Transaction without penalty, except for the retention by Neptune in certain circumstances of the payment of [*] on the signing hereof in accordance with footnote 1 under "Payment Terms" below. * 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. 2 3 The parties intend that the transaction be structured in a way so as to constitute a "reorganization" under Section 368(a)(1)(C) (or another applicable provision of Section 368) of the Internal Revenue Code of 1986, as amended (the "IRC"), and to the extent that any provisions of this Letter are inconsistent with that intention, the intent of the parties shall, to the extent possible, prevail over such provisions and result in a reformation, to the extent practicable, of such provisions. Neptune and its shareholders agree to make such representations and warranties, and to execute such instruments, as Cellegy or its counsel may request in order to carry out such intention, including without limitation the adoption of a plan of liquidation by Neptune. Upon signing of this binding Letter, Neptune agrees that until December 31, 1997 or the earlier mutual abandonment of the transaction contemplated hereby, Neptune will not, and will not allow any officer or director of Neptune or any other person on its behalf, to negotiate or accept any offer from any party concerning the possible disposition of all or any substantial portion of Neptune's assets, equity or business. Neptune will promptly notify Cellegy of any such inquiries or proposals. Neptune makes the representation and warranties to Cellegy that are set forth on Exhibit A attached to this Letter. Cellegy makes the representations and warranties to Neptune that are set forth on Exhibit A attached to this Letter. Covenants: Cellegy and Neptune will cooperate and use their good faith efforts to satisfy the conditions to closing described below and, upon satisfaction of such conditions, to consummate the transactions contemplated hereby. After the execution of this Letter, Neptune will: (i) use its best efforts to operate its business in the ordinary course thereof and consistently with its past practices; (ii) use its best efforts to protect the Acquired Assets, cooperate with Cellegy concerning protection of intellectual property rights relating to the Acquired Assets and take such actions as Cellegy may reasonably request (at Cellegy's expense) relating to protection of such assets, and effect no transfer, sale, assignment, lease, license or encumbrance of or on any of its Acquired Assets; (iii) engage in no transactions materially inconsistent with its representations and warranties in this Letter; (iv) provide Cellegy with all information and supporting documents concerning the Acquired Assets and Neptune's business that Cellegy requests in connection with its due diligence; (v) use its best efforts to obtain, before the Closing, the written consent of all third parties necessary for Neptune to consummate the Transaction and to transfer and assign the Acquired Assets to Cellegy; (vi) notify Cellegy promptly upon receipt of any communication or legal process which commences or threatens litigation against Neptune, its business, or any of the Acquired Assets; (vii) provide Cellegy, whether before or after the Closing, with any further documents which Cellegy reasonably requests to investigate the Acquired Assets or the business of Neptune or to carry into effect the Transaction; (viii) pay any sales, use or other taxes (other than capital gain or income taxes imposed on the individual Neptune shareholders) as a result of the Transaction; and (ix) upon the Closing, cease use of the Intellectual Property without Cellegy's prior written consent. 3 4 Neptune covenants and agrees that if Neptune or its shareholders receive any shares of Cellegy Common Stock, then they will agree to a lock-up restriction similar to those executed by Cellegy directors with respect to the current proposed public offering of common stock by Cellegy, which restriction currently prevents sale of shares they hold until 90 days after the effective date of the registration statement relating to that offering, except for private resale of such shares to persons who agree to be subject to such lock-up restrictions. Cellegy agrees that from the date of this Letter until the Closing, subject to its rights described herein not to consummate the Transaction, it will (i) use all reasonable efforts to conduct its business in such a manner so as to not be in material breach of the representations and warranties made to Neptune herein, (ii) use its best efforts to obtain before the Closing the written consent of all third parties necessary for Cellegy to consummate the Transaction, and (iii) notify Neptune promptly upon receipt of any communication or legal process which commences or threatens litigation relating to the Acquired Assets or the transactions contemplated hereby. From the date hereof until the closing, Neptune will preserve and operate its business in the ordinary course and will not enter into any transaction or agreement or take any action out of the ordinary course or enter into any transaction or make any commitment involving an expense or capital expenditure by Neptune relating to the Acquired Assets, in excess of $5,000, without Cellegy's prior written consent. Cellegy agrees that after the Closing, it will undertake commercially reasonable efforts for a product of similar commercial potential as the Acquired Assets, consistent with Cellegy's other business opportunities, financial condition, prospects and commercial business judgment, to develop and commercialize the Acquired Product in a reasonably timely manner. The foregoing shall not require Cellegy to undertake development or commercialization efforts that are inconsistent with the foregoing standard. If Neptune believes that Cellegy is not so developing or commercializing the Acquired Product, it may notify Cellegy, and the parties shall promptly meet and confer regarding Cellegy's development and commercialization efforts. If after such meeting Neptune continues to believe that Cellegy is not so developing or commercializing the Acquired Product, it may initiate arbitration proceedings, in the manner provided herein, regarding Cellegy's efforts. The closing of the transactions contemplated by this Letter and the Agreement will occur promptly upon satisfaction of all closing conditions, but within all events not later than December 31, 1997, unless one or more regulatory or governmental consents or approvals that is required to be obtained before the Closing has not been obtained through no fault of either party, in which case the Closing shall occur as soon as reasonably possible after such consent or approval has been obtained. Cellegy's Closing Conditions: Cellegy's obligations under this Agreement are subject to the satisfaction of each of the following conditions, except as Cellegy may waive in writing: (i) Cellegy shall have completed such investigation of the Acquired Assets and of Neptune's business as it deems appropriate and shall be satisfied with its due diligence, including with respect to Neptune's ownership of its intellectual property and any other matter affecting 4 5 Cellegy's ownership of the Acquired Assets or liabilities or obligations with respect to the Acquired Assets; (ii) no material adverse change shall have occurred in Neptune's business or in the Assets since the execution of this Letter; (iii) on the Closing Date, all actions, proceedings, instruments and documents required by Neptune to effect the Transaction and all other related matters shall have been completed to the reasonable satisfaction of Cellegy's counsel; (iv) Neptune's representations and warranties shall remain true in all material respects as if made on the Closing Date; (v) all third-party consents which are required to assign and transfer the Acquired Assets shall have been obtained; (vi) Neptune shall have performed in all material respects all of the terms and obligations of this Letter that are required to be performed by Neptune before the Closing; and (vii) no action, claim or proceeding shall have been brought or threatened against any party seeking to challenge or prohibit the transactions contemplated hereby or claims any rights to any of the Acquired Assets. Neptune's Closing Conditions: Neptune's obligations under this Letter are subject to the satisfaction of each of the following conditions, except as Neptune may waive in writing: (i) Cellegy's representations and warranties made in this Letter shall remain true in all material respects as if made on the Closing Date; (ii) Cellegy shall have performed in material respects and be in material compliance with all of the terms and obligations of this Letter that are required to be performed by Cellegy at or before the Closing Date; (iii) Cellegy shall have delivered the purchase price; and (iv) there shall not have been a material adverse change in Cellegy's business since the date of this Letter (provided, however, that neither a claim brought by a third party related to the Acquired Assets, nor a decline in the market price of Cellegy's Common Stock, shall be deemed to be a material adverse change in Cellegy's business). Indemnity: (i) "LOSS" shall mean any liability, injury, damage, expense, cost, fine or penalty resulting from any action, proceeding, demand, assessment, judgment or award (including without limitation costs of investigation, prosecution, defense or settlement), including attorneys fees, costs and expenses related thereto. (ii) Neptune and its shareholders shall jointly and severally indemnify and hold harmless Cellegy, its directors, officers, shareholders, employees and agents from any Loss arising from (A) breach of a covenant or inaccuracy or untruth of a representation or warranty of Neptune in this Letter, (B) taxes, assessments or other governmental charges arising from Neptune's business through the Closing Date, (C) any claim alleging liability against Neptune or Cellegy for any act, omission of Neptune or its directors, officers or employees or circumstance relating to Neptune's business arising before the Closing Date, (D) any claim of infringement or violation of the intellectual property rights of a third party or failure of Neptune to be the owner of the intellectual property included in the Acquired Assets or otherwise to have good title to the Acquired Assets, (E) any claim or cause of action alleging liability related to any past agreement with any of Neptune's employees or independent contractors, any agreement between Neptune and any third party relating to the Acquired Assets, or any claim by a third party arising out of or relating to the matters set forth in the Disclosure Letter, (F) any claim or cause of action by or on behalf of a creditor of Neptune asserting liability against Cellegy, as purchaser of the Acquired Assets, or seeking to impose any lien or any other encumbrance upon any of the Acquired Assets, for obligations of Neptune, (G) any Loss arising out of or relating to any pilot, 5 6 preclinical, clinical or other studies or trials or other use by any person of the Acquired Assets authorized by or conducted by, for or at the request of Neptune relating to any of the Acquired Assets, and (H) any expenses in excess of $5,000 that are incurred by Cellegy to obtain consents of third parties to assignment or transfer of the Acquired Assets. The indemnity obligations of the Neptune shareholders hereunder shall in no event exceed the amounts paid to Neptune hereunder (with respect to shares, valued based on the market price on the date received by Neptune), plus any amounts that may be withheld pursuant to the first sentence of subparagraph (v) below. (iii) Cellegy shall indemnify and hold harmless Neptune, its directors, officers, shareholders, employees and agents from or relating to any Loss arising from any of the following: (A) breach of a covenant or inaccuracy or untruth of any representation or warranty of Cellegy in this Letter; and (B) any claim against Neptune or its shareholders relating to the Acquired Assets and based solely on acts or omissions of Cellegy or its directors, officers or employees after the Closing Date relating to the Acquired Assets. (iv) The obligation of the parties under this Paragraph shall survive the Closing. (v) Cellegy may recover the amount of any Loss from the portion of the purchase price that is withheld or from amounts otherwise payable pursuant to the provisions of this Letter. If an indemnified party intends to assert a claim for indemnification, it must first notify the indemnifying parties; no claim for indemnification may, however, be paid until the aggregate of such claims exceeds $20,000. If the indemnifying parties dispute the claim, they shall deliver a notice of dispute within thirty days of the date on which the notice of Loss was delivered, and the dispute shall be resolved by binding arbitration in San Francisco, California under the Commercial Arbitration Rules of the American Arbitration Association. Each party shall select one arbitrator, and the two arbitrators so selected shall appoint the third arbitrator. The parties shall each pay one-half of the costs of the arbitrators. The arbitration shall be resolved as soon as reasonably possible. The parties have separately executed a confidentiality agreement, which shall remain in full force and effect. Notwithstanding that agreement, the parties understand that Cellegy may issue a press release upon the execution of this Letter and/or the closing of the transactions contemplated by this Letter and the Agreement, and intends to include information concerning Neptune, the "acquired product" and related matters in the registration statement. Neptune and its officers, directors and shareholders agree to cooperate with Cellegy to provide such information (including without limitation any financial information) that may be required for inclusion in the registration statement. Each company will be responsible for its own fees and expenses in connection with the proposed transaction. Neptune acknowledges that it has not entered into, and will not enter into, any agreement that would result in a broker's or finder's fee pertaining to the proposed transaction. 6 7 This Letter and any disputes arising out of or relating to this Letter, shall be governed by the laws of the State of California (excluding its choice of law rules). The parties agree that the exclusive means for resolving any dispute arising out of or relating to this Letter shall be binding arbitration to be held in San Francisco, California, pursuant to the Commercial Arbitration Rules of the American Arbitration Association.
PAYMENT TERMS: AMOUNT Upon signing of Letter of Intent (1) $ Upon closing of the Agreement (1) [*] Upon FDA approval for OTC treatment of hemorrhoids: (2) 5,000,000
The purchase price shall be allocated in the manner set forth on an exhibit to be prepared by Cellegy before the Closing, which allocation must be reasonably satisfactory to Neptune. The allocation shall be consistent in all material respects with applicable regulations of the Internal Revenue Service. Notes: (1) The initial payment to Neptune and the payment to be made to Neptune at the Closing will be made in shares of Cellegy Common Stock, valued at the closing price of the Common Stock on the date this Letter is signed by both Cellegy and Neptune or, if this Letter is not signed by both parties on a business day, then on the most recent preceding business day (e.g., if the Letter is signed on a Saturday, then the preceding Friday) (in either case, the "Agreement Date FMV"). If the parties do not consummate the transaction because of Neptune's bad faith or intentional misconduct or because in the course of Cellegy's due diligence Cellegy discovers facts or - ------- * 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. 7 8 circumstances that are inconsistent in material respects with the representations and warranties of Neptune relating to the Acquired Assets and that can reasonably be expected to have a material adverse effect on the value of the Acquired Assets, then without limiting Cellegy's other remedies, the $250,000 will be promptly refunded to Cellegy. The foregoing shall not be deemed to reduce or modify Neptune's obligations hereunder to consummate the transactions contemplated hereby. (2) All subsequent payments will be made in a form of consideration that will be intended to preserve the tax-free treatment of the acquisition to Neptune. Subsequent payments will be made in Cellegy's Common Stock. All payments in stock will be made in such quantities which result by dividing the relevant payment amount by the actual closing market price of the Common Stock on the date the relevant payment (the "Payment Date FMV") or milestone is due or achieved; provided, however, that the Payment Date FMV shall in all events be deemed to be no higher than $15 per share even if the actual closing market price of the Common Stock is higher than such amount. Cellegy will have a "call right, " exercisable within two business days, to redeem any such shares that are issued at a purchase price equal to the dollar amount of the milestone payment due. All of the above milestone payments, except for the final payment following OTC approval, shall become due and payable in connection with any sale by Cellegy of all or substantially all of its assets to a third party, or any merger or similar transaction in which Cellegy is acquired and in which Cellegy's shareholders do not, immediately after the closing of such transaction, have at least a majority of the voting power and equity interest of the surviving company. Cellegy will agree to file a registration statement on Form S-3 (or other suitable form) after the closing in order to register for resale the shares of Common Stock issued to Neptune or its shareholders at or after the closing of the transaction, and to use all reasonable efforts to cause the registration statement to become effective before expiration of 90 days from the effective date of the registration statement relating to the Company's current underwritten public offering (or, if the closing of such offering is not consummated before December 31, 1997, then before March 31, 1998, and to keep such registration effective until all registered shares have been sold or until, with respect to any particular shareholder, such shares may be sold without volume limitations pursuant to Rule 144, and/or file subsequent registrations to cover shares that may be issued after the closing date. In order to effect an orderly and expeditious transfer of intellectual property, and a rapid initiation of the formulation development and clinical programs, Neptune covenants that Dr. Stephen Gorfine will dedicate a portion of his time to the oversight of the clinical program. In the capacity of Clinical Consultant, Dr. Gorfine will work closely with Cellegy's CEO, Mr. K. Michael Forrest, Dr. Dan Azarnoff, VP of Clinical and Regulatory Affairs, Dr. Michael Francoeur, VP of Research and Development, Dr. Carl Thornfeldt, Chairman and Medical Director, and other Cellegy or CRO personnel, as required. Dr. Gorfine will serve in this role for a period of approximately two years or until the clinical program is complete. While acting in this capacity, Dr. Gorfine will receive compensation in the amount of $2,000 per day in return for up to four days of his time, exclusive of travel, per month. Dr. Gorfine will also be reimbursed for normal and customary business expenses carried out at the request of Cellegy. It 8 9 would be a condition to Cellegy's obligation to close the transactions contemplated by the Agreement that Dr. Gorfine have entered into a consulting agreement on terms consistent in all material respects with those described above. [Remainder of this page intentionally left blank] 9 10 IN WITNESS WHEREOF, the parties have executed this Binding Letter of Intent as of the date first written above. CELLEGY PHARMACEUTICALS, INC. NEPTUNE PHARMACEUTICAL CORPORATION By:________________________________ By:_________________________________ Its:_______________________________ Its:________________________________ 10 11 EXHIBIT A NEPTUNE'S REPRESENTATIONS AND WARRANTIES. Neptune represents and warrants to Cellegy that, except as set forth in a schedule of exceptions dated the date hereof and separately delivered by Neptune to Cellegy (the "Disclosure Letter"), each of the following is a true and complete statement: (i) Neptune is a corporation duly organized under the laws of the State of Missouri and is qualified or licensed to do business in all states where Neptune is required to be so qualified or licensed; (ii) Neptune before the Closing Date Neptune will have taken all corporate and shareholder action necessary to authorize its consummation of the Transaction and the performance of its obligations under this Agreement; (iii) the execution of this Agreement and the performance of Neptune's obligations hereunder will not (A) cause a violation of Neptune's articles of incorporation or bylaws, (B) cause a breach under, or allow any party to terminate, or require the consent of any third party under, any agreement to which Neptune is a party or by which the business or property of Neptune is bound (other than the requirement to obtain the consent of the other party to certain agreements to the assignment of such agreements to Cellegy, which consents Neptune will obtain before the Closing), or (C) cause any violation of law or of a judgment or order of any court or governmental body; (iv) Neptune holds good and merchantable title to all Acquired Assets, free and clear of any liens, encumbrances or claims, and no other party has any right or interest whatsoever in any of the Acquired Assets, including without limitation any license, option, right of first refusal or right to acquire, or development, manufacturing, marketing or distribution rights, relating to any of the Acquired Assets; (v) Neptune has made all filings with governmental agencies and obtained all assignments (including invention assignments from its employees) necessary to claim and protect its rights in all intellectual property included in the Acquired Assets, and none of the Acquired Assets (including the Intellectual Property) infringes upon or violates any patent, copyright, trademark, trade secret or other intellectual property rights of any other person or entity; (vi) the financial statements of Neptune delivered to Cellegy fairly present the financial condition of Neptune and its business as of their respective dates; (vii) Neptune has timely filed all tax returns and timely paid all taxes due; (viii) except as set forth on Exhibit A hereto, there is no litigation, arbitration, proceeding or governmental investigation (each an "ACTION") pending against any of Neptune, its properties, business, directors, officers or employees, nor to the best of Neptune's knowledge is there any factual or legal basis for any Action; (ix) Neptune has not agreed to pay a brokerage or finder's fee in connection with the Transaction or the Agreement; and (x) there are no liabilities, obligations, or claims (whether contingent or otherwise) relating to the Acquired Assets that are not disclosed in the Disclosure Letter. CELLEGY'S REPRESENTATIONS AND WARRANTIES. Cellegy represents and warrants to Neptune that each of the following is a true and complete statement: (i) Cellegy is a corporation duly organized under the laws of the State of California; (ii) before the Closing Date Cellegy will have taken all corporate and shareholder action necessary to authorize its consummation of the Transaction and the performance of its obligations under this Agreement; (iii) the execution of this Agreement and the performance of Cellegy's obligations hereunder will not (A) cause a violation of Cellegy's articles of incorporation or bylaws, (B) cause a breach under, or allow any party to terminate, or require the consent of any third party under, any agreement to which the Cellegy is a party or by which the business or property of Cellegy is bound (other than such 11 12 consents, if any, as Cellegy will obtain before the Closing), or (C) cause any violation of law or of a judgment or order of any court or governmental body; and (iv) to Cellegy's knowledge, Cellegy's registration statement on Form S-1 filed with the Securities and Exchange Commission in October 1997 does not, as of the date of such registration statement, contain an omission of material fact or omit to state a material fact required to be stated therein in order to make the statements contained therein not misleading. Cellegy expressly does not make any representation or warranty concerning the tax consequences of the transactions contemplated by this Letter to Neptune and its shareholders. 12 EX-23.1 4 CONSENT OF ERNST & YOUNG LLP 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, except note 10, as to which the date is November 5, 1997, in the Registration Statement (Form S-1) No. 333-38179 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 November 5, 1997 -----END PRIVACY-ENHANCED MESSAGE-----