FORM 10-Q SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark one) [x] QUARTERLY REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 1996 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________________to _____________ Commission File Number 0-16132 CELGENE CORPORATION ------------------------------------------------------------- (Exact name of registrant as specified in its charter) Delaware 22-2711928 -------------------------------------------------- ---------------------- (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) 7 Powder Horn Drive, Warren, New Jersey 07059 --------------------------------------- ----- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: 908-271-1001. Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No _______ _______ At October 31, 1996, 9,933,943 shares of Common Stock, and 377 shares of Series A Convertible Preferred Stock, par value $.01 per share, were outstanding. CELGENE CORPORATION INDEX TO FORM 10-Q Page No. -------- PART I - FINANCIAL INFORMATION Item I Unaudited Condensed Financial Statements Condensed Balance Sheets as of September 30, 1996 (unaudited) and December 31, 1995 3 Unaudited Condensed Statements of Operations - Nine-Month Periods Ended September 30, 1996 and 1995 4 Unaudited Condensed Statements of Operations - Three-Month Periods Ended September 30, 1996 and 1995 5 Unaudited Condensed Statements of Cash Flows - Nine-Month Periods Ended September 30, 1996 and 1995 6 Notes to Unaudited Condensed Financial Statements 8 Item 2 Management's Discussion and Analysis of Financial Condition and Results of Operations 11 PART II - OTHER INFORMATION 15 Signatures 16 2 PART I - FINANCIAL INFORMATION Item 1 - Condensed Financial Statements CELGENE CORPORATION CONDENSED BALANCE SHEETS ASSETS (Unaudited) Sept 30, 1996 Dec 31, 1995 ------------- ------------ Current assets: Cash and cash equivalents $ 3,106,470 $ 337,165 Marketable securities available for sale 20,602,589 11,375,740 Accounts receivable 250,271 397,241 Other current assets 721,581 404,011 ------------ ------------ Total current assets 24,680,911 12,514,157 Plant and equipment, net 1,889,400 1,207,805 Deferred costs 180,823 448,006 Other assets 41,250 41,250 ------------ ------------ $ 26,792,384 $ 14,211,218 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,429,104 $ 607,206 Accrued expenses 1,000,147 1,610,846 ------------ ------------ Total current liabilities 2,429,251 2,218,052 Convertible debentures 2,026,043 4,592,366 Convertible debentures - accrued interest 344,153 258,299 ------------ ------------ Total liabilities 4,799,447 7,068,717 ------------ ------------ Stockholders' equity: Preferred stock, par value $.01 per share. Authorized 5,000,000 shares Series A convertible, redeemable, cumulative preferred; issued and outstanding 428 shares at September 30, 1996 includes $590,511 accretion of premium 21,990,511 -- Common stock, par value $.01 per share Authorized 20,000,000 shares; issued 9,674,582 and 8,807,863 shares at September 30, 1996 and December 31, 1995, respectively 96,746 88,079 Additional paid-in capital 83,645,930 78,064,288 Unamortized deferred compensation - restricted stock (2,267) (7,085) Accumulated deficit (83,638,397) (70,989,400) Net unrealized gain (loss) on marketable securities available for sale 653 (13,138) Common stock in treasury, at cost 29,985 and 24,271 shares at September 30, 1996 and December 31, 1995, respectively (100,239) (243) ------------ ------------ Total stockholders' equity 21,992,937 7,142,501 ------------ ------------ $ 26,792,384 $ 14,211,218 ============ ============ See accompanying notes to financial statements 3 CELGENE CORPORATION UNAUDITED CONDENSED STATEMENTS OF OPERATIONS Nine-Month Period Ended Sept 30, -------------------------------- 1996 1995 ---- ---- Revenues: Sales of chemical intermediates $ 1,096,605 $ 389,153 Research contracts 711,666 385,000 Investment income 989,751 309,066 ------------ ------------ 2,798,022 1,083,219 ------------ ------------ Expenses: Cost of goods sold 683,005 529,444 Research and development 10,981,813 5,048,998 Selling, general and administrative 2,762,528 2,038,550 Interest expense and other financing charges 360,535 232,185 ------------ ------------ 14,787,881 7,849,177 ------------ ------------ Net loss ($11,989,859) ($ 6,765,958) Accretion of premium payable on preferred stock (659,138) -- ------------ ------------ Net loss applicable to common shareholders ($12,648,997) ($ 6,765,958) ============ ============ Net loss applicable to common shareholders per share of common stock ($ 1.37) ($ .86) ------------ ------------ Weighted average number of shares of common stock outstanding 9,227,000 7,881,000 ============ ============ See accompanying notes to financial statements 4 CELGENE CORPORATION UNAUDITED CONDENSED STATEMENTS OF OPERATIONS Three Month Period Ended Sept 30, ---------------------------------- 1996 1995 ---- ---- Revenues: Sales of chemical intermediates $ 77,800 $ 147,015 Research contracts 376,666 145,000 Investment income 359,086 120,326 ----------- ----------- 813,552 412,341 ----------- ----------- Expenses: Cost of goods sold 234,390 165,518 Research and development 4,661,390 1,702,704 Selling, general and administrative 1,274,289 674,296 Interest expense and other financing charges 173,379 232,185 ----------- ----------- 6,343,448 2,774,703 ----------- ----------- Net loss ($5,529,896) ($2,362,362) Accretion of premium payable on preferred stock (276,938) -- ------------ ------------- Net loss applicable to common shareholders ($ 5,806,834) ($2,362,362) ============ ============ Net loss applicable to common shareholders per share of common stock ($ .62) ($ .30) ----------- ----------- Weighted average number of shares of common stock outstanding 9,520,000 7,918,000 =========== =========== See accompanying notes to financial statements. 5 CELGENE CORPORATION UNAUDITED CONDENSED STATEMENTS OF CASH FLOW Nine-Month Period Ended Sept 30, --------------------------------- 1996 1995 ---- ---- Operating activities: Net loss applicable to common shareholders ($ 12,648,997) ($ 6,765,958) Non-cash items: Depreciation and amortization 684,983 669,659 Amortization of deferred compensation 4,818 9,539 Interest on convertible debentures and other financing charges 360,535 232,185 Accretion of premium payable on preferred stock 659,138 -- Change in current assets and liabilities: Increase in accounts payable and accrued expenses 211,199 131,737 Decrease in accounts receivable 146,969 363,281 Increase in other current assets (317,570) (208,463) ------------- ------------- Net cash used in operating activities ($ 10,898,925) ($ 5,568,020) Investment activities: Capital expenditures (1,186,284) (15,533) Proceeds from sales and maturities of marketable securities available for sale 117,485,212 7,576,076 Purchase of marketable securities available for sale (126,698,269) (13,006,734) ------------- ------------- Net cash used in investment activities (10,399,341) (5,446,191) Financing activities: Net proceeds from the issuance of convertible debentures -- 11,022,570 Net proceeds from exercise of common stock options 237,946 147,245 Net proceeds from sale of preferred stock 23,829,625 -- ------------- ------------- Net cash provided by financing activities 24,067,571 11,169,815 Net change in cash and cash equivalents $ 2,769,305 $ 155,604 Cash and cash equivalents at beginning of period 337,165 292,925 ------------- ------------- Cash and cash equivalents at end of period $ 3,106,470 $ 448,529 ============= ============= Non-cash investing activities: Net change in net, unrealized gain(loss) on securities available for sale $ 13,791 $ 145,886 ============= ============= See accompanying notes to financial statements. 6 CELGENE CORPORATION UNAUDITED CONDENSED STATEMENTS OF CASH FLOW (Continued) Nine-Month Period Ended Sept 30, -------------------------------- 1996 1995 ---- ---- Non-cash financing activities: Issuance of common stock upon the conversion of convertible debentures and accrued interest thereon, net $2,649,115 $1,796,436 ========== ========== Issuance of warrants for services rendered in connection with the issuance of convertible debentures $ -- $ 94,500 ========== ========== Issuance of common stock upon the conversion of convertible preferred stock and accrued accretion thereon, net $3,818,627 -- ========== ========== Issuance of common stock upon issuance of options through the return of previously common stock outstanding $ 99,996 -- =========== ========== See accompanying notes to financial statements 7 CELGENE CORPORATION Notes to Unaudited Condensed Financial Statements September 30, 1996 1. Basis of Presentation The unaudited condensed financial statements have been prepared from the books and records of Celgene Corporation (the "Company") in accordance with generally accepted accounting principles for interim financial information pursuant to Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. Interim results may not be indicative of the results that may be expected for the year. The interim condensed financial statements should be read in conjunction with the financial statements and notes thereto included in the Company's latest annual report on Form 10K. 2. Series A Convertible Preferred Stock On March 13, 1996, in a private placement, the Company completed the sale of 503 shares of Series A Convertible Preferred Stock, par value $.01 per share (the "Preferred Stock"), at an issue price of $50,000 per share. The Company received net proceeds, after offering costs, of $23,829,625. The Preferred Stock, plus dividends at a rate of 4.9% per year, is convertible into common stock of the Company at the option of the holders thereof at a conversion price per share of common stock equal, generally, to the lesser of (i) $18.81 or (ii) 90% of the average closing price per share of the common stock for the seven trading days immediately prior to the date of conversion. The average closing price per share of common stock for the seven trading days immediately prior to September 30, 1996 was $10.96. The Company may redeem the shares in increments of no less than $1.5 million commencing December 13, 1996, on thirty business days written notice to the stockholders, at a price that equals a specified premium, ranging from 120% to 130%, of the purchase price plus dividends. Under certain conditions, upon receipt of a conversion notice from the holder, the Company has the right (i) to redeem shares presented for conversion, or (ii) to defer conversion for 90 days in exchange for warrants to purchase additional shares of common stock as specified in the Certificate of Designation of Series A Preferred Stock. Any shares of Series A Convertible Preferred Stock outstanding on March 13, 1998 shall be converted automatically into common stock on such date at the conversion price then in effect. The holders of Preferred Stock have no voting rights. The Company granted registration rights to the subscribers in the private placement that require the Company to file a registration statement covering the shares of Common Stock of the Company underlying the Preferred Stock. A registration statement with respect to investors resales of common shares underlying the convertible preferred stock was filed and declared effective on June 10, 1996. Through September 30, 1996 the Company had accrued $659,138 representing accretion of premium on the Preferred Stock of which $590,511 relates to preferred shares not yet tendered for conversion. 8 As of September 30, 1996, 75 shares (as of October 31, 1996, 126 shares) of the Series A Preferred Stock, with their respective accrued accretion, had been converted into 451,969 (741,315 at October 31, 1996) shares of common stock. As of September 30, 1996 the Company had issued warrants that entitle certain stockholders of the Series A Preferred Stock to purchase 116,981 (123,071 at October 31, 1996)shares of common stock at an exercise price of $11.50. The warrants were issued in exchange for the deferral of conversion for 90 days. These warrants are exercisable for a period of two years from the date of issuance. In connection with the private placement, the Company granted to certain executives and affiliates of the placement agent warrants, valued at $60,168, to purchase an aggregate of 66,853 shares of Common Stock at an exercise price of $20.52, subject to proportional adjustment in the event that the Company undertakes a stock split, stock dividend, recapitalization or similar event. These warrants are exercisable for a period of five years from the date of issuance. 3. Convertible Debentures In the quarter ended September 30, 1995, the Company sold in a private placement offering, 8% convertible debentures due July 31, 1997 in the aggregate principal amount of $12,000,000, and received net proceeds, after offering costs, of $11,022,570. Such debentures are convertible into common stock of the Company at the option of either the holders thereof or the Company. The holders of the convertible debentures may convert the debentures into common stock of the Company at a conversion price that varies and is based upon the market price (as defined) of the common stock on the date of conversion. The Company may require the conversion of the convertible debentures commencing October 15, 1995 through July 30, 1997 at a conversion price of the common stock on the date of conversion. The Company also has the right to redeem any convertible debenture after it has received a notice of conversion with respect to such debenture. The redemption price is the greater of 115% of the principal and the accrued interest on the redeemed debenture or an amount which is based on the appreciation of the common stock from the date of issuance of the debentures. The conversion price of the convertible debentures is subject to adjustment under certain circumstances. During the quarter ended September 30, 1996, there were no conversions of convertible debentures. As of September 30, 1996, convertible debentures in the aggregate principal amount of $9,750,000, plus accrued interest, had been converted into a total of 1,268,597 shares of common stock. No interest was paid in cash. 9 4. Marketable Securities Available for Sale Marketable securities available for sale at September 30, 1996 include debt securities with maturities ranging from October, 1996 to October, 1997. A summary of marketable securities at September 30, 1996 is as follows: Gross Gross Estimated Unrealized Unrealized Fair Cost Gain Loss Value ------------------ ---------------- ------------------ ---------------- US Government and agency obligations $2,473,133 $31 - $2,473,164 Certificates of deposit $1,000,035 - ($83) $999,952 Asset backed security $1,000,665 $84 - $1,000,749 Corporate bonds $4,029,340 - ($521) $4,028,819 Commercial paper $12,098,763 $1,142 - $12,099,905 ------------------ ---------------- ------------------ ---------------- Total $20,601,936 $1,257 ($604) $20,602,589 ================== ================ ================== ================ The net change in the gross unrealized gain for the quarter ended September 30, 1996 was a decrease of approximately $5,400. The proceeds from sales for the quarter ended September 30, 1996 included gross realized gains and losses of approximately $92,000 and $100 respectively. The assets that back the asset backed security are credit card receivables held in an irrevocable trust. The trust has received the highest possible rating from Moodys, Standard & Poors and Fitch. The corporate bonds are A rated or better and the commercial paper rating is A1P1. 10 PART I - FINANCIAL INFORMATION Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations Liquidity and Capital Resources On September 30, 1996 the Company had available working capital of approximately $22,252,000, consisting principally of cash, cash equivalents and marketable securities available for sale, which represents an increase of approximately $11,957,000 from December 31, 1995 primarily due to the private placement of Series A Convertible Preferred Stock in March, 1996. On March 13, 1996, in a private placement, the Company completed a sale of 503 shares of Series A convertible Preferred Stock, par value $0.01 per share, at an issue price of $50,000 per share, for total gross proceeds of $25,150,000. The Company received net proceeds, after offering costs, of approximately $23,800,000. The Company has entered into certain technology agreements with various parties which require payments of approximately $380,000 within the next eighteen months. In December, 1995 the Company entered into an agreement with Penn Pharmaceutical, Ltd. to build a special facility devoted exclusively to the production of SYNOVIR(R), the Company's experimental drug, which has been approved by the FDA for expanded distribution, prior to final evaluation by that agency. Under the terms of the agreement, based on certain milestones with respect to commencing production and FDA inspection, the Company is responsible for $320,000 of start-up and validation costs. In addition, the Company will lease the dedicated facility for a three year period. Annual facility payments are $268,000, which commence in the month the first milestone is completed. It is expected that monthly rent payments will commence before the end of 1996. Penn will manufacture SYNOVIR and sell it to the Company at a price to be agreed upon. In August 1992, the Company entered into a two-year research and development agreement with the Rockefeller University. In July 1994 this agreement was extended for an additional two years. This agreement was extended for another two years in March 1996. Under the terms of the contract extension, the Company is committed to an annual fee to Rockefeller University of $504,000 paid semi-annually in April and October. Nine-month period ended September 30, 1996 vs Nine-month period ended September 30, 1995 Revenues for the nine-month period ended September 30, 1996 were approximately $2,798,000, which was an increase of approximately $1,715,000, or 158%, over the comparable period in 1995. Chiral intermediate revenues increased approximately $707,000 to $1,097,000 for the nine-month period ended September 30, 1996 as compared to the comparable 1995 period. This increase in chiral intermediate revenues was due primarily to repeat orders reflecting customers' increased requirements as their products advance through clinical trials. Chiral intermediate revenues are derived from developmental projects that may or may not move forward in development or to commercialization. 11 Therefore, these revenues are sporadic in nature. Chiral research contract revenues for the first nine months were approximately $712,000 which was an increase of approximately $327,000 over the first nine months of 1995. This increase in contract revenues was due to the Company entering into new research contracts for developmental compounds and for expanding development of existing compounds. Revenue backlog at September 30, 1996, for chiral intermediates and research contracts increased approximately $575,000, or 34%, to $1,013,000 as compared to the September 30, 1995 backlog. The Company is negotiating with new and existing customers for additional chiral intermediate and research contract orders; however, there is no assurance that these efforts will be successful. Investment income increased approximately $681,000 to $990,000 in the nine months of 1996 as compared to the nine months of 1995 due to the increase in funds available for investment. Investment income is expected to decline as the Company continues to utilize its funds towards the commercialization of SYNOVIR. For the nine months ended September 30, 1996, cost of goods sold increased approximately $154,000, or 29%, to $683,000 (which includes certain fixed manufacturing costs) as compared to the nine months of 1995, due to the higher volume of chiral intermediate revenues. Research and development expenses for the nine month period ended September 30, 1996 increased by approximately $5,933,000, or 118%, to $10,982,000 as compared to the same period in 1995. This increase was due to an increase of approximately $4.9 million in expenses associated with the immunotherapeutic program and approximately $1.0 million in expenses for the chiral research group. The increase in expenses associated with immunotherapeutic programs was the result of an increase in pre-clinical and clinical trial expenses, which increased by approximately $2.4 million; regulatory and compliance expenses, which increased approximately $ 1.1 million; manufacturing of developmental quantities of SYNOVIR, which increased expenses approximately $508,000; research and development personnel costs which increased by approximately $353,000; and other research and development expenses, which rose approximately $539,000. Research and development expenses associated with the immunotherapeutic programs are anticipated to increase to an even greater degree as the Company expects to incur substantial regulatory and clinical trial related expenses related to the filing of an NDA for SYNOVIR. Selling, general and administrative expenses for the nine-month period ended September 30, 1996 increased approximately $724,000, to $2,763,000 as compared to the 1995 comparable period, primarily due to the amortization of the convertible debenture offering cost, the addition of product liability insurance and the initial costs associated with market development activities leading to the commercialization of SYNOVIR. Net loss, applicable to common shareholders for the nine-month period ended September 30, 1996 was approximately $12,649,000, an increase of approximately $5,883,000, or 87%, over the comparable period in 1995, due primarily to the increase in research and development spending as the Company moves toward the filing of its first NDA. 12 Three-month period ended September 30, 1996 vs Three-month period ended September 30, 1995 Revenues for the three-month period ended September 30, 1996 were approximately $814,000, which was an increase of approximately $401,000, over the comparable period in 1995. Chiral intermediate revenues decreased $69,000 to $78,000 for the three-month period of 1996, as compared to the comparable 1995 period. The decrease in chiral intermediate revenues was due primarily to the sporadic nature of orders. Chiral research contract revenues for the third quarter were $377,000, which was an increase of approximately $232,000 over the third quarter of 1995. The increase in chiral contract revenue was due primarily to the expansion of an ongoing project with a major multi-national agrochemical company. Revenue backlog at September 30, 1996, for chiral intermediates and research contracts, was approximately $1,013,000. Investment income increased $239,000, compared to the third quarter of 1995, due to the increase in funds invested. Investment income is expected to decline as the Company continues to utilize its funds towards the commercialization of SYNOVIR. For the third quarter ended September 30, 1996, cost of goods sold increased $69,000, or 42%, to $234,000 (which includes certain fixed manufacturing costs) as compared to the third quarter of 1995, due to an increase in fixed manufacturing expenses. Research and development expenses for the three-month period ended September 30, 1996 increased by $2,958,000, or 174%, to $4,661,000 as compared to the same period in 1995. This increase was due primarily to approximately $2.3 million in higher expenses associated with the immunotherapeutic program and approximately $623,000 in expenses for the chiral research group. The increase in expenses associated with immunotherapeutic programs reflected growing preclinical and clinical trials expenses, which increased approximately $1.4 million; regulatory and compliance expenses, which increased approximately $500,000, research and development personnel costs which increased by approximately $255,000; manufacturing of developmental quantities of SYNOVIR which increased approximately $33,000; and other research and development expenses, which increased approximately $112,000. Research and development expenses associated with the immunotherapeutic programs are anticipated to increase to an even greater degree as the Company expects to incur substantial regulatory and clinical trial related expenses relating to filing an NDA for SYNOVIR. Selling, general and administrative expenses for the three-month period ended September 30, 1996 increased $600,000, or 89%, to $1,274,000 as compared to the 1995 comparable period due primarily to the addition of product liability insurance and the initial costs associated with market development activities leading to the commercialization of SYNOVIR. Net loss, applicable to common shareholders, for the three-month period ended September 30, 1996 was approximately $5,807,000 which was an increase of approximately $3,444,000, or 146%, over the comparable period in 1995, due to the increase in R&D expenditures for the immunotherapeutic program. Other Matters A New Drug Application (NDA) for SYNOVIR for the treatment of ENL (erythema nodosum leprosum), a severe leprosy-related inflammatory condition, will be submitted to the Food and Drug Administration (FDA) prior to year-end. The Company has completed the pivotal clinical trial for SYNOVIR for severe weight loss (cachexia) associated with AIDS, and anticipates the announcement of results early in the first quarter of 1997. This will be followed shortly thereafter by a submission of an NDA, assuming satisfactory safety and efficacy data. In addition, SYNOVIR Phase II clinical trials for the 13 treatment of chronic intractable diarrhea in HIV positive patients are progressing. Cautionary Statements For Forward Looking Information The Management Discussion and Analysis of Financial Condition and Results of Operations provided above contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward looking statements. These factors include results of current or pending clinical trials, actions by the FDA and those factors detailed in the company's filings with the Securities and Exchange Commission. 14 PART II - OTHER INFORMATION Item 1.- None Item 2.- None Item 3.- None Item 4.- None Item 5.- None Item 6.- Exhibits (a) 3.2 Celgene Corporation By-laws as amended and restated as of September 16, 1996 (incorporated by reference to the Company's Current Report on Form 8-K filed on September 16, 1996). 10.28 Rights Agreement dated as of September 16, 1996 between Celgene Corporation and American Stock Transfer & Trust Company (incorporated by reference to the Company's Registration Statement on Form 8-A filed on September 16, 1996). 27 Financial Data Schedule - Article 5 for third quarter Form 10-Q. (b) A Current Report on Form 8-K with respect to Item 5 of Form 8-K was filed on September 16, 1996. 15 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. CELGENE CORPORATION DATE November 14, 1996 BY /s/ John W. Jackson ------------------------------ -------------------------------------- John W. Jackson Chairman of the Board Chief Executive Officer DATE November 14, 1996 BY /s/ Sanford Kaston ------------------------------ ------------------------------------- Sanford Kaston Controller (Chief Accounting Officer) 16 STATEMENT OF DIFFERENCES The registered symbol shall be expressed as (R)