ONXX Onyx Pharmaceuticals, Inc. (MM)

Onyx Pharmaceuticals Reports Second Quarter and Six Month 2004 Financial Results RICHMOND, Calif., Aug. 9 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) reported a net loss of $13.1 million, or $0.38 per share, for the second quarter ended June 30, 2004 compared with a net loss of $11.4 million, or $0.48 per share, for the same quarter in 2003. The second quarter 2004 results reflect increased clinical development and marketing expenditures for Onyx's lead product candidate, BAY 43-9006. An orally active small molecule anticancer compound, BAY 43-9006, is being codeveloped with Bayer Pharmaceuticals Corporation. "The anticipated growth in operating expenses reflects the increased expenditures from our Phase III trial and the initiation of other clinical trials evaluating BAY 43-9006 in a number of different tumor types," said Hollings C. Renton, Onyx's president and chief executive officer. "Though we expect some quarter-to-quarter variability, the net loss for 2004 is estimated to be in the range of $50 to $55 million as we continue these clinical trials and incur premarketing expenses." Renton added, "Our financial performance for the first half of 2004 is consistent with previously provided company guidance and reflects our commitment to expediting the development of BAY 43- 9006." For the quarters ended June 30, 2004 and 2003, Onyx reported no revenue. Total operating expenses of $13.8 million increased by $2.5 million in the second quarter as compared to the same period in the prior year. This change reflects increased clinical development and marketing expenses for BAY 43- 9006. Research and development costs were $9.8 million in the second quarter of 2004 compared to $6.7 million in the second quarter of 2003, an increase of $3.1 million over the comparable period last year. BAY 43-9006 development expenses increased by $6.2 million while therapeutic virus expenses decreased by $3.1 million due to the termination of the program in 2003. Marketing costs increased to $1.5 million in the second quarter of 2004 compared to $0.2 million in the second quarter of 2003 due to an increase in internal and external resources allocated to BAY 43-9006. General and administrative costs increased to $2.2 million in the second quarter of 2004 compared to $1.6 million in the second quarter of 2003. Restructuring charges related to the 2003 discontinuation of the therapeutic virus program decreased to $0.3 million in the second quarter of 2004 as compared to $2.8 million in the same period in the prior year. As of June 30, 2004, the company had cash, cash equivalents, and marketable securities of $237.2 million compared to $105.4 million at December 31, 2003. The increase was due to a public offering completed in February 2004 which resulted in net proceeds of $148.3 million to Onyx. Six-month Results For the six months ended June 30, 2004, the company reported a net loss of $21.3 million, or $0.63 per share, compared with a net loss of $22.1 million, or $0.95 per share, for the same period in 2003. There were no revenues recorded in the first six months of 2004 and 2003. Operating expenses increased by $0.4 million during the six-month period ended June 30, 2004 as compared to the same period in the prior year. Onyx's management will host a teleconference and webcast discussing the company's second quarter and six-month 2004 financial results. The event will be held today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Interested parties may access the live webcast at: http://audioevent.mshow.com/179451 or by dialing 706-679-4614 and using the passcode 9143944. A replay of the presentation will be available on the Onyx website, or by dialing 706-645-9291, approximately three hours after the teleconference concludes. The replay will be available through September 9, 2004. Onyx Pharmaceuticals is engaged in the development of novel cancer therapies that target the molecular basis of cancer. With its collaborators, the company is developing small molecule drugs, including BAY 43-9006 with Bayer Pharmaceuticals Corporation. For more information about Onyx's pipeline and activities, visit the company's website at http://www.onyx-pharm.com/. This press release contains forward-looking statements regarding expectations about the development of BAY 43-9006 and anticipated 2004 losses. These forward-looking statements involve a number of risks and uncertainties that could cause actual events to differ from the company's expectations. These risks are addressed in the company's periodic reports filed with the Securities and Exchange Commission, including but not limited to its Annual Report on Form 10-K filed on March 15, 2004 and its Quarterly Reports on Form 10-Q. ONYX PHARMACEUTICALS, INC. SUMMARY FINANCIAL INFORMATION CONDENSED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (unaudited) Three Months Ended Six Months Ended June 30, June 30, 2004 2003 2004 2003 Total revenue $-- $-- $-- $-- Operating expenses: Research and development 9,844 6,715 16,574 15,752 Marketing 1,471 229 1,760 309 General and administrative 2,229 1,563 3,915 2,865 Restructuring 258 2,759 258 3,201 Total operating expenses 13,802 11,266 22,507 22,127 Loss from operations (13,802) (11,266) (22,507) (22,127) Interest income, net 696 135 1,220 308 Other income (expense) -- (275) -- (275) Net loss $(13,106) $(11,406) $(21,287) $(22,094) Basic and diluted net loss per share $(0.38) $(0.48) $(0.63) $(0.95) Shares used in computing basic and diluted net loss per share 34,723 23,820 33,639 23,274 CONDENSED BALANCE SHEETS (In thousands) June 30, Dec. 31, 2004 2003 (unaudited) (1) Assets Cash, cash equivalents and marketable securities $237,245 $105,400 Other current assets 4,411 3,045 Total current assets 241,656 108,445 Property and equipment, net 268 285 Other assets 411 408 Total assets $242,335 $109,138 Liabilities and stockholders' equity Current liabilities $17,237 $15,619 Advance from collaboration partner 20,000 20,000 Stockholders' equity 205,098 73,519 Total liabilities and stockholders' equity $242,335 $109,138 (1) Derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2003. DATASOURCE: Onyx Pharmaceuticals, Inc. CONTACT: Julie Wood of Onyx Pharmaceuticals, Inc., +1-510-262-8757 Web site: http://www.onyx-pharm.com/

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