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Onyx Pharmaceuticals Reports 2008 First Quarter Results
Date:5/6/2008

Nexavar Net Sales increase 149% over First Quarter 2007

EMERYVILLE, Calif., May 6 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today reported its financial results for the first quarter ended March 31, 2008. Onyx reported net income of $15.4 million, or $0.27 per diluted share, for the first quarter of 2008 compared to a net loss of $12.2 million, or $0.26 per diluted share, in the same period in 2007.

Nexavar net sales as reported by Bayer HealthCare Pharmaceuticals, Inc., or Bayer, were $151.9 million for the first quarter ended March 31, 2008, a 149% increase over the $60.9 million reported in the same period in 2007. Onyx with its collaborator, Bayer, is marketing and developing Nexavar(R) (sorafenib) tablets, an anticancer therapy currently approved for the treatment of liver cancer and advanced kidney cancer in the United States, European Union, and other territories internationally.

"We are pleased with Nexavar's strong performance in the first quarter of 2008, generating worldwide net sales of $151.9 million, which we attribute to the continued successful launch of Nexavar in liver cancer in both the United States and in the rest of the world," said Tony Coles, M.D., president and chief executive officer of Onyx. "While we continue the global launch of Nexavar in liver cancer, we are focusing commercial efforts on the further development of this new market to support the long-term growth of this important opportunity. At the same time, we are investing in a broad clinical program to realize the potential benefits of Nexavar in numerous other tumor types."

The net profit for the first quarter ended March 31, 2008, included employee stock-based compensation expense of $5.2 million, or $0.09 per diluted share. The net loss for the quarter ended March 31, 2007, included employee stock-based compensation expense of $3.0 million, or $0.06 per diluted share.

Net Revenue from Unconsolidated Joint Business

In the first quarter of 2008, Onyx reported net revenue from unconsolidated joint business of $37.7 million compared to $3.0 million for the first quarter of 2007. The net revenues from unconsolidated joint business were based on total Nexavar sales of $151.9 million in the first quarter of 2008. The increase in net revenue from unconsolidated joint business over prior year is due to the increase in Nexavar revenue recognized by Bayer offset by the increase in combined commercial and research and development expenses for Nexavar. The calculation of this line item is shown in the table following the Condensed Statement of Operations.

Operating Expenses

In the first quarter of 2008, Onyx recorded research and development expenses of $7.4 million, an increase of $1.9 million over the first quarter of 2007. The increase in expenses incurred in the first quarter of 2008 was primarily due to higher costs incurred for the breast cancer program. Research and development expenses included $0.6 million of employee stock-based compensation for the first quarter of 2008 and $0.5 million for the first quarter of 2007.

In the first quarter of 2008, selling, general and administrative expenses were $19.8 million, an increase of $6.7 million over the first quarter of 2007. The increase in selling, general and administrative expenses was primarily due to increases in stock-based compensation, other employee-related expenses and increased marketing expense to support Nexavar. Selling, general and administrative expenses included $4.6 million of employee stock-based compensation in the first quarter of 2008 compared to $2.5 million for the first quarter of 2007.

Cash, Cash Equivalents and Marketable Securities

As of March 31, 2008, the company had cash, cash equivalents, and short and long-term marketable securities of $456.6 million compared to $469.7 million at December 31, 2007. This decrease was primarily due to cash used in operations for the three months ended March 31, 2008.

Conference Call with Management Today

Onyx's management will host a teleconference and webcast to provide an update on Nexavar and discuss first quarter 2008 financial results. The event will begin at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) on May 6, 2008. Interested parties may access a live webcast of the presentation on our website at:

http://www.onyx-pharm.com/wt/page/event_calendar

or by dialing 630-691-2760 and using the passcode 21488196. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3044 and using the passcode 21488196 approximately one hour after the teleconference concludes. The replay will be available through June 6, 2008.

About Onyx Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer by changing the way cancer is treated(TM). The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar(R) (sorafenib) tablets, a small molecule drug. Nexavar is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in non-small cell lung cancer, melanoma, breast cancer and other cancers. For more information about Onyx, visit the company's website at: http://www.onyx-pharm.com.

Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals Inc.

This news release contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding sales trends and commercial activities and the timing, progress and results of clinical development, regulatory filings and actions. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2007, filed with the Securities and Exchange Commission under the heading "Risk Factors" for a more detailed description of such factors, as well as the company's subsequent quarterly reports on Form 10-Q. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

(See attached tables.)

ONYX PHARMACEUTICALS, INC.

SUMMARY FINANCIAL INFORMATION

CONDENSED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(unaudited)

Three Months Ended Mar. 31,

---------------------------

2008 2007

------- -------

Net revenue from unconsolidated joint

business $37,738 $3,025

Operating expenses:

Research and development (1) 7,438 5,534

Selling, general and administrative (1) 19,844 13,183

------ ------

Total operating expenses 27,282 18,717

------ ------

Income (loss) from operations 10,456 (15,692)

Investment income 5,271 3,497

------ ------

Income (loss) before income taxes 15,727 (12,195)

Provision for income taxes 309 -

------ ------

Net income (loss) $15,418 $(12,195)

====== ======

Net income (loss) per share:

Basic $0.28 $(0.26)

====== ======

Diluted $0.27 $(0.26)

====== ======

Shares used in computing net income

(loss) per share:

Basic 55,388 46,278

====== ======

Diluted 56,566 46,278

====== ======

(1) Includes employee stock-based compensation

charges of:

Research and development $580 $525

Selling, general, and administrative 4,636 2,464

------ ------

$5,216 $2,989

====== ======

ONYX PHARMACEUTICALS, INC.

CALCULATION OF NET REVENUE (EXPENSE) FROM UNCONSOLIDATED JOINT BUSINESS

(In thousands, unaudited)

Three Months Ended Mar. 31,

---------------------------

2008 2007

------- -------

Product revenue, net $151,896 $60,881

Combined cost of goods sold,

distributed, selling, general and

administrative expenses 62,703 36,450

Combined research and development expenses 37,478 33,290

------- -------

Combined collaboration profit (loss) $51,715 $(8,859)

======= =======

Onyx's share of collaboration profit (loss) $25,858 $(4,430)

Reimbursement of Onyx's direct

development and marketing expenses 11,880 7,455

------- -------

Onyx net revenue from unconsolidated

joint business $37,738 $3,025

------- -------

ONYX PHARMACEUTICALS, INC.

CONDENSED BALANCE SHEETS

(In thousands)

Mar. 31, Dec. 31,

2008 2007

(unaudited) (2)

------- -------

Assets

Cash, cash equivalents and marketable

securities $408,286 $469,650

Other current assets 45,397 11,006

------- -------

Total current assets 453,683 480,656

Property and equipment, net 2,840 3,146

Long-term investments 48,328 -

Other assets 286 281

------- -------

Total assets $505,137 $484,083

======= =======

Liabilities and stockholders' equity

Current liabilities 21,888 11,441

Advance from collaboration partner 30,372 39,234

Other long term liabilities 1,260 1,171

Stockholders' equity 451,617 432,237

------- -------

Total liabilities and stockholders'

equity $505,137 $484,083

======= =======

(2) Derived from the audited financial statements included in the

company's Annual Report on Form 10-K for the year-ended December 31,

2007.


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SOURCE Onyx Pharmaceuticals, Inc.
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