U.S. SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________ FORM 10-Q ( X ) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 1997 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: 0-28298 ------- ONYX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 94-3154463 - ------------------------------- ------------------------ (State or other jurisdiction of (IRS Employer ID Number) incorporation or organization) 3031 Research Drive Richmond, California 94806 (Address of principal executive offices) (510) 222-9700 (Registrant's telephone number including area code) Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 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. (XX) Yes ( ) No The number of outstanding shares of the registrant's Common Stock, $0.001 par value, was 9,809,057 as of July 31, 1997. ONYX PHARMACEUTICALS, INC. INDEX PART I: FINANCIAL INFORMATION PAGE ITEM 1. Financial Statements Condensed balance sheets - June 30, 1997 and December 31, 1996 3 Condensed statements of operations - three and six months ended June 30, 1997 and 1996 4 Condensed statements of cash flows - six months ended June 30, 1997 and 1996 5 Notes to condensed financial statements 6 ITEM 2. Management's discussion and analysis of financial condition and results of operations 9 PART II: OTHER INFORMATION ITEM 2. Changes in Securities 13 ITEM 4. Submission of Matters to a Vote of Security Holders 13 ITEM 6. Exhibits and Reports on Form 8-K 13 SIGNATURES 14 EXHIBIT INDEX 15 2 ONYX PHARMACEUTICALS, INC. PART I: FINANCIAL INFORMATION ITEM 1: FINANCIAL STATEMENTS CONDENSED BALANCE SHEETS (In thousands, except share data) June 30, December 31, 1997 1996 ----------- ------------ (unaudited) ASSETS Current assets: Cash and cash equivalents $ 7,152 $ 36,258 Short-term investments 30,370 4,071 Other current assets 618 638 -------- -------- Total current assets 38,140 40,967 Property and equipment, net 4,061 4,196 Notes receivable from related parties 800 396 Other assets 209 220 -------- -------- TOTAL ASSETS $ 43,210 $ 45,779 -------- -------- -------- -------- LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 786 $ 693 Accrued liabilities 2,346 1,277 Accrued compensation 476 439 Deferred revenue 846 1,631 Long-term debt, current portion 270 444 -------- -------- Total current liabilities 4,724 4,484 Long-term debt, noncurrent portion - 99 Deferred rent 154 273 Stockholders' equity: Preferred stock, $0.001 par value; 5,000,000 shares authorized, none issued and outstanding - - Common stock, $0.001 par value: 25,000,000 shares authorized, 9,805,395 and 9,514,285 shares issued and outstanding as of June 30, 1997 and December 31, 1996, respectively 10 10 Additional paid-in capital 74,682 71,132 Deferred compensation (522) (632) Accumulated deficit (35,838) (29,587) -------- -------- Total stockholders' equity 38,332 40,923 -------- -------- TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 43,210 $ 45,779 -------- -------- -------- -------- See accompanying notes. 3 ONYX PHARMACEUTICALS, INC. CONDENSED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (unaudited) Three Months Ended Six Months Ended June 30, June 30, ------------------ ----------------- 1997 1996 1997 1996 -------- ------- ------- ------- Revenue: Contract and other revenue $ 303 $ 88 $ 610 $ 250 Contract revenue from related parties 1,845 1,812 3,690 3,624 -------- ------- ------- ------- Total revenue 2,148 1,900 4,300 3,874 Operating expenses: Research and development 5,103 3,541 8,980 7,083 General and administrative 1,327 1,058 2,593 1,913 -------- ------- ------- ------- Total operating expenses 6,430 4,599 11,573 8,996 -------- ------- ------- ------- Loss from operations (4,282) (2,699) (7,273) (5,122) Interest income, net 524 332 1,022 462 -------- ------- ------- ------- Net loss $ (3,758) $(2,367) $(6,251) $(4,660) -------- ------- ------- ------- -------- ------- ------- ------- Net loss per share $ (0.39) $ (0.65) -------- ------- -------- ------- Shares used in computing net loss per share 9,680 9,602 -------- ------- -------- ------- Pro forma net loss per share $ (0.29) $ (0.63) ------- ------- ------- ------- Shares used in computing pro forma net loss per share 8,074 7,358 ------- ------- ------- ------- See accompanying notes. 4 ONYX PHARMACEUTICALS, INC. CONDENSED STATEMENTS OF CASH FLOW (In thousands) (unaudited) Six months ended June 30, --------------------- 1997 1996 --------- --------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ (6,251) $ (4,660) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 865 731 Forgiveness of note receivable - 25 Amortization of deferred compensation 110 137 Changes in assets and liabilities: Other current assets 20 73 Other assets 11 (77) Accounts payable 93 63 Accrued liabilities 1,069 457 Accrued compensation 37 90 Deferred revenue (785) (26) Deferred rent (119) (1,271) --------- --------- Net cash used in operating activities (4,950) (4,458) --------- --------- CASH FLOWS FROM INVESTING ACTIVITIES: Purchases of short-term investments (30,370) (11,407) Sales and maturities of short-term investments 4,071 8,704 Capital expenditures (730) (784) Notes receivable from related parties (404) - Proceeds from sale of fixed assets - - --------- --------- Net cash used in investing activities (27,433) (3,487) --------- --------- CASH FLOWS FROM FINANCING ACTIVITIES: Payments on long-term debt (273) (220) Net proceeds from issuance of common stock 3,550 35,311 Repurchase of common stock - - --------- --------- Net cash provided by financing activities 3,277 35,091 --------- --------- Net increase (decrease) in cash and cash equivalents (29,106) 27,146 Cash and cash equivalents at beginning of the period 36,258 3,779 --------- --------- Cash and cash equivalents at end of the period $ 7,152 $ 30,925 --------- --------- --------- --------- See accompanying notes. 5 ONYX PHARMACEUTICALS, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS JUNE 30, 1997 (unaudited) NOTE 1. BASIS OF PRESENTATION The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q. 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 of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 1997 are not necessarily indicative of the results that may be expected for the year ending December 31, 1997. For further information, refer to the financial statements and footnotes thereto for the year ended December 31, 1996 included in the ONYX Pharmaceuticals, Inc. (the "Company" or "ONYX") Annual Report on Form 10-K. NOTE 2. NET LOSS PER SHARE Net loss per share is computed using the weighted average number of common shares outstanding. Common equivalent shares are excluded from the computation as their effect is antidilutive, except that, pursuant to the Securities and Exchange Commission ("SEC") Staff Accounting Bulletins, common and common equivalent shares issued during the 12-month period prior to the filing of a registration statement in connection with the Company's initial public offering at prices below the public offering price of $12.00 have been included in the calculation as if they were outstanding for all periods presented through March 31, 1996 (using the treasury stock method for stock options at the estimated public offering price). Pro forma net loss per share for the three and six months ended June 30, 1996 has been computed as described above and also gives effect to the conversion of convertible preferred shares not included above that automatically converted upon completion of the Company's initial public offering (using the if converted method) from original date of issuance. Historical net loss per share for 1996 is as follows: Three months ended Six months ended June 30, 1996 June 30, 1996 ------------------ ---------------- Net loss per share $ (0.41) $ (1.29) --------- --------- --------- --------- Shares used in computing net loss per share 5,814 3,608 --------- --------- --------- --------- In February 1997, the Financial Accounting Standards Board issued Statement No. 128, Earnings per share, which is required to be adopted on December 31, 1997. At that time, the Company will be required to change the method currently used to compute earnings per share and to restate all prior periods. The impact on earnings per share for the three and six months ended June 30, 1997 and 1996 will not be material. 6 ONYX PHARMACEUTICALS, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS JUNE 30, 1997 (unaudited) NOTE 3. COLLABORATIVE AGREEMENTS In accordance with the terms of the agreement dated May 4, 1995, Warner-Lambert Company ("Warner-Lambert") purchased 192,941 shares of common stock of the Company on May 2, 1997 at an aggregate purchase price of approximately $3,333,000. NOTE 4. MARKETABLE SECURITIES - AVAILABLE-FOR-SALE The following is a summary of available-for-sale securities as of June 30, 1997: Available-for-sale Securities Estimated fair value (in thousands) -------------------- Cash equivalents: U.S. corporate securities $ 2,490 Money market funds 4,662 -------- Total cash equivalents: 7,152 -------- Short-term investments: U.S. corporate securities 12,823 Foreign corporate securities 9,896 U.S. government securities 2,037 -------- Total short-term investments 24,756 -------- Total available-for-sale securities $ 31,908 -------- -------- As of June 30, 1997, the difference between the fair value and the amortized cost of available-for-sale securities was insignificant. The average portfolio duration is approximately five months, and the contractual maturity of each of the investments does not exceed two years. Held at June 30, 1997, and excluded from short-term investments above, is $5,614,000 of certificates of deposits. NOTE 5. LINE OF CREDIT In March 1997, the Company entered into a $7 million line of credit arrangement with a bank. The line bears interest at prime plus 1% and expires October 15, 1997. The line is secured by certain assets of the Company and contains covenants related to maintaining debt-to-equity ratios, tangible net worth minimums, cash and investment balances, as well as a restriction on paying dividends or repurchasing stock. As of June 30, 1997, no balance was outstanding on the line of credit. 7 ONYX PHARMACEUTICALS, INC. NOTES TO CONDENSED FINANCIAL STATEMENTS JUNE 30, 1997 (unaudited) NOTE 6. SUBSEQUENT EVENT On July 31, 1997, the Company signed a three-year research and development agreement with Warner-Lambert aimed at discovering new therapeutics to regulate inflammation and autoimmunity. Terms of the agreement provide for receipt by the Company of an up-front licensing fee payable in three stages, as well as milestone payments and royalties on eventual product sales. In return, Warner-Lambert receives exclusive worldwide marketing rights to products emerging from the collaboration. Total payments to the Company prior to commercialization could total nearly $30 million. Warner-Lambert has the right to terminate the agreement at its discretion on January 31, 1999 upon written notice and provided that research payments to the Company are continued through July 31, 1999. In addition, Warner-Lambert may terminate the research portion of the agreement, and associated research funding and milestone payments, at its discretion if a project director acceptable to Warner-Lambert has not been hired by ONYX prior to January 31, 1998. 8 ONYX PHARMACEUTICALS, INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS EXCEPT FOR THE HISTORICAL INFORMATION CONTAINED HEREIN, THIS OVERVIEW AND THE FOLLOWING DISCUSSION CONTAIN FORWARD-LOOKING STATEMENTS THAT INVOLVE RISKS AND UNCERTAINTIES. THE COMPANY'S ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE DISCUSSED HERE. FACTORS THAT COULD CAUSE OR CONTRIBUTE TO SUCH DIFFERENCES INCLUDE, BUT ARE NOT LIMITED TO, THOSE DISCUSSED IN THE ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 1996. OVERVIEW Since its inception, ONYX Pharmaceuticals, Inc. (the "Company" or "ONYX") has been engaged in the discovery and development of novel therapeutics based upon the genetics of human disease, with an emphasis on cancer. Currently, the Company has five therapeutic discovery programs focused on the following cancer mutations: p53, ras, cell cycle, BRCA1 and APC. The Company intends to pursue its therapeutic discovery programs independently and in collaboration with pharmaceutical companies, and to collaborate with such companies on the development and commercialization of any products which may result from the Company's discovery programs. The Company has entered into collaborative agreements with Bayer Corporation ("Bayer") in the area of ras oncogenes, Warner-Lambert Company ("Warner-Lambert") in the cell cycle area and Eli Lilly and Company ("Eli Lilly") on the function of the BRCA1 gene in breast cancer. During the quarter ended June 30, 1997, the Company completed initial Phase I safety studies of ONYX-015 in patients with recurrent and refractory head and neck cancer. ONYX-015 was found to be safe and well-tolerated, as well as biologically active. Based on the results of this first Phase I study, the Company initiated a Phase II efficacy trial of ONYX-015 in the same patient population. Three Phase I trials are also now underway, including pancreatic and ovarian cancers, and gastrointestinal cancers that have metastasized to the liver. In addition, a lead compound was identified in the ras collaboration with Bayer Corporation. On July 31, 1997, the Company signed a three-year research and development agreement with Warner-Lambert aimed at discovering new therapeutics to regulate inflammation and autoimmunity. The Company believes that expanding into the area of inflammation is a natural step for the Company because some of the same biochemical pathways that lead to cancer also play an important role in the development of inflammatory disorders. Terms of the agreement provide for receipt by the Company of an up-front licensing fee payable in three stages, as well as milestone payments and royalties on eventual product sales. In return, Warner-Lambert receives exclusive worldwide marketing rights to products emerging from the collaboration. Total payments to the Company prior to commercialization could total nearly $30,000,000. Warner-Lambert has the right to terminate the agreement at its discretion on January 31, 1999 upon written notice and provided that research payments to the Company are continued through July 31, 1999. In addition, Warner-Lambert may terminate the research portion of the agreement, and associated research funding and milestone payments, at its discretion if a project director acceptable to Warner-Lambert has not been hired by ONYX prior to January 31, 1998. The Company has not been profitable since inception and expects to incur substantial and increasing losses for the foreseeable future, primarily due to the expansion of its research and development programs, including clinical trials in the p53 program. The Company expects that losses will fluctuate from quarter to quarter and that such fluctuations may be substantial. As of June 30, 1997, the Company's accumulated deficit was approximately $35,800,000. The Company's business is subject to significant risks, including the risks inherent in its research and development efforts, uncertainties associated with obtaining and enforcing patents, the lengthy and expensive regulatory approval process and competition from other products. The Company does not expect to generate revenues from the sale of proposed products in the foreseeable future. 9 ONYX PHARMACEUTICALS, INC. RESULTS OF OPERATIONS THREE AND SIX MONTHS ENDED JUNE 30, 1997 AND 1996. REVENUES The Company's revenues increased 13% to $2,148,000 and 11% to $4,300,000 for the three and six months ended June 30, 1997, respectively, as compared to the same periods in 1996. Revenues for the 1996 periods were $1,900,000 and $3,874,000, respectively. Revenues for the three and six months ended June 30, 1997 and 1996 were attributable to amounts earned for research performed under the Company's collaborations with Bayer, Warner-Lambert and Eli Lilly. The increase in revenues for the three and six months ended June 30, 1997 is primarily due to an expanded agreement with Eli Lilly which increased the funding levels under the agreement as compared to the funding levels in 1996. RESEARCH AND DEVELOPMENT EXPENSES Research and development expenses increased 44% to $5,103,000 and 27% to $8,980,000 for the three and six months ended June 30, 1997, respectively, as compared to the same periods in 1996. The increase was primarily due to additional clinical costs associated with current and planned Phase I and Phase II clinical trials of ONYX-015, the lead product in the Company's p53 program. The Company expects that research and development expenses will continue to grow significantly during future periods due to the hiring of personnel and the expansion of ONYX-015 clinical studies. GENERAL AND ADMINISTRATIVE EXPENSES General and administrative expenses increased 25% to $1,327,000 and 36% to $2,593,000 for the three and six months ended June 30, 1997, respectively, as compared to the same periods in 1996. The increase was primarily due to increased administrative staffing, additional costs incurred in connection with corporate development activities and higher expenses associated with the Company's reporting and other requirements associated with operating as a publicly held company. General and administrative expenses are expected to increase to support the Company's research and development efforts. NET INTEREST INCOME The Company had net interest income of $524,000 and $1,022,000 for the three and six months ended June 30, 1997 and 1996, respectively, as compared with $332,000 and $462,000 for the same periods in 1996. The increase in net interest income reflects the Company's higher average balance of cash, cash equivalents and short-term investments resulting primarily from its initial public offering of common stock in May 1996. LIQUIDITY AND CAPITAL RESOURCES Since inception, the Company's cash expenditures have substantially exceeded its revenues. The Company has relied primarily on the proceeds from the sale of equity securities and revenue from collaborative research and development agreements to fund its operations. The Company's cash, cash equivalents and short-term investments were $37,522,000 at June 30, 1997, compared with $40,329,000 at December 31, 1996. Increasing levels of clinical research and product development associated with ONYX-015, the lead product in the p53 Program, and the higher levels of general and administrative expenses resulted in approximately $4,950,000 of cash used in operations for the six months ended June 30, 1997. This cash decline was partially offset by Warner-Lambert's $3,333,000 purchase of 192,941 shares of common stock in May 1997. The Company expects cash used in operations will continue to increase as additional clinical trials for ONYX-015 commence. 10 ONYX PHARMACEUTICALS, INC. Total capital expenditures for equipment and leasehold improvements for the six months ended June 30, 1997 were $730,000. The Company expects to make expenditures of approximately $1,900,000 for the remainder of 1997 for capital equipment and improvements to its existing facility. The Company anticipates that its existing capital resources and interest thereon, and anticipated revenues from its existing collaborations will be sufficient to fund its current and planned operations through the end of 1998. There can be no assurance, however, that changes in the Company's operating expenses will not result in the expenditure of such resources before such time, and in any event, the Company will need to raise substantial additional capital to fund its operations in future periods. As of June 30, 1997, the Company had $7,000,000 available through a line of credit which expires on October 15, 1997. BUSINESS RISKS The Company is at an early stage of development. The development of the Company's technology and proposed products will require a commitment of substantial funds to conduct these costly and time-consuming activities. All of the Company's potential products are in research or development and will require significant additional research and development efforts prior to any commercial use, including extensive preclinical and clinical testing as well as lengthy regulatory approval. The development of new products is subject to a number of significant risks. Potential products that appear to be promising at an early stage of development may not reach the market for a number of reasons. Such risks include the possibilities that the potential products will be found ineffective or unduly toxic during clinical trials, fail to receive necessary regulatory approvals, be difficult to manufacture on a large scale, be uneconomical to market or be precluded from commercialization by proprietary rights of third parties. In addition, many of the Company's potential products are subject to development and licensing arrangements with the Company's collaborators. Therefore, the Company is dependent on the research and development efforts of these collaborators. Moreover, the Company is entitled to only a portion of the revenues, if any, realized from the commercial sale of any of the potential products covered by the collaborations. Should the Company or its collaborators fail to perform in accordance with the terms of any of their agreements or terminate such agreements without cause, any consequent loss of revenue under the agreements could have a material adverse effect on the Company's results of operations. There can be no assurance that the Company will be able to maintain existing collaborative agreements, negotiate collaborative arrangements in the future on acceptable terms, if at all, or that any such collaborative arrangements will be successful. To the extent that the Company is not able to maintain or establish such arrangements, the Company would be required to undertake such activities at its own expense. The proposed products under development by the Company have never been manufactured on a commercial scale, and there can be no assurance that such products can be manufactured at a cost or in quantities necessary to make them commercially viable. The Company has no sales, marketing or distribution capability. If any of its products subject to collaborative agreements are successfully developed, the Company must rely on its collaborators to market such products. If the Company develops any products which are not subject to collaborative agreements, it must either rely on other large pharmaceutical companies to market such products or must develop a marketing and sales force with technical expertise and supporting distribution capability in order to market such products directly. The Company intends to seek additional funding through collaborative arrangements, public or private equity or debt financings, capital lease transactions or other financing sources that may be available. However, there can be no assurance that additional financing will be available on acceptable terms or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing stockholders may result. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its research or development programs or to obtain funds through collaborative arrangements with others that are on unfavorable terms or that may require the Company to relinquish 11 ONYX PHARMACEUTICALS, INC. rights to certain of its technologies, product candidates or products that the Company would otherwise seek to develop itself. The foregoing risks reflect the Company's early stage of development and the nature of its industry and proposed product. Also inherent in the Company's stage of development is a range of additional risks, including competition, uncertainties regarding protection of patents and proprietary rights, government regulation and uncertainties regarding health care reform. 12 ONYX PHARMACEUTICALS, INC. PART II: OTHER INFORMATION ITEM 2. CHANGES IN SECURITIES On May 2, 1997, the Company sold 192,941 shares of Common Stock to Warner-Lambert Company for an aggregate purchase price of $3,333,000. The sale of such shares to Warner-Lambert Company was deemed to be exempt from registration under the Securities Act of 1933, as amended, pursuant to Rule 4(2) thereof, as a transaction not involving a public offering. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS (a) The Annual Meeting of Stockholders of ONYX Pharmaceuticals, Inc., a Delaware corporation ("ONYX") was held on May 22, 1997. (b) Each of management's nominees to the Board of Directors was elected to serve until the Company's annual meeting of stockholders in 2000. The nominees were: Paul Goddard, Ph.D., 8,556,498 common shares for, 15,657 withheld; Randy Thurman, 8,556,398 common shares for and 15,757 withheld; and Wendell Wierenga, Ph.D., 8,555,177 common shares for and 16,978 withheld. (c) (i) The other matter presented to the stockholders at the Annual Meeting was the ratification of selection of Ernst & Young LLP as independent auditors of ONYX for the fiscal year ending December 31, 1997: 8,553,048 common shares for, 9,883 against, 9,224 abstain and 0 non-votes. (ii) ONYX also solicited the approval of the stockholders on the following matters: A. An increase of 600,000 shares to the aggregate number of shares of Common Stock authorized for issuance under the 1996 Equity Incentive Plan, as amended, and to add provisions to such plan with respect to Section 162(m) of the Internal Revenue Code of 1986, as amended: 5,934,740 common shares for, 697,630 against, 15,931 abstain and 1,923,854 non-votes B. An amendment to the 1996 Non-Employee Directors' Plan, as amended, to allow non-employee directors who are also consultants to receive option grants under the plan: 8,031,352 common shares for, 357,805 against, 28,417 abstain and 154,581 non-votes ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K a) Exhibits Exhibit 11.1 Statement Regarding Computation of Net Loss Per Share Exhibit 27.1 Financial Data Schedule b) Form 8-K No reports on Form 8-K were filed during the period covered by this report. 13 ONYX PHARMACEUTICALS, INC. 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. ONYX PHARMACEUTICALS, INC. Date: August 14, 1997 By: /s/ Hollings C. Renton ----------------------------------- Hollings C. Renton President, Chief Executive Officer and Director (Principal Executive Officer) Date: August 14, 1997 By: /s/ Douglas L. Blankenship ----------------------------------- Douglas L. Blankenship Treasurer (Principal Financial and Accounting Officer) 14 ONYX PHARMACEUTICALS, INC. EXHIBIT INDEX Sequentially Numbered Exhibit Number Description of Exhibits Page - -------------- ----------------------- ------------ 11.1 Statement Regarding Computation of Net Loss per Share 27.1 Financial Data Schedule 15