8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 6, 2009

ONYX PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

DELAWARE	0-28298	94-3154463
(State of incorporation)	(Commission File No.)	(IRS Employer Identification No.)

2100 Powell Street
Emeryville, California 94608
(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (510) 597-6500

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

ITEM 2.02 RESULTS OF OPERATIONS AND FINANCIAL CONDITION

On May 6, 2009, Onyx Pharmaceuticals, Inc. issued a press release announcing financial results for the first quarter ended March 31, 2009. A copy of the earnings press release is furnished as Exhibit 99.1 to this report.

This information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in Exhibit 99.1 shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Onyx Pharmaceuticals, Inc., whether made before or after the date here of, regardless of any general incorporation language in such filing.

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS

(d) Exhibits

Exhibit Number	Description
99.1	Press Release titled “Onyx Pharmaceuticals Reports First Quarter 2009 Financial Results,” dated May 6, 2009

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 hereunto duly authorized.

Date: May 6, 2009	ONYX PHARMACEUTICALS, INC.
	By:	/s/ Matthew K. Fust
		Matthew K. Fust
		Executive Vice President and Chief Financial Officer

EXHIBIT INDEX

Number	Description
99.1	Press Release titled “Onyx Pharmaceuticals Reports First Quarter 2009 Financial Results,” dated May 6, 2009

EX-99.1

Exhibit 99.1

Contacts:
Julie Wood	Matthew K. Fust
Vice President, Investor Relations	Executive Vice President & Chief Financial Officer
510-597-6505	510-597-6392

Onyx Pharmaceuticals Reports First Quarter 2009 Financial Results
Nexavar Net Sales Drive Continued Profitability and Support Expanded Product Development

EMERYVILLE, CA — May 6, 2009 — Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today reported its financial results for the first quarter 2009. Global Nexavar net sales as reported by Onyx’s collaborator Bayer HealthCare Pharmaceuticals, or Bayer, were $178.1 million for the first quarter 2009, a 17% increase compared to $151.9 million in the same period in 2008. Onyx and Bayer are marketing and developing Nexavar^® (sorafenib) tablets, an anticancer therapy currently approved for the treatment of liver cancer and advanced kidney cancer in the U.S., European Union and other territories.

Onyx reported non-GAAP net income, excluding employee stock-based compensation expense, of $8.1 million, or $0.14 per diluted share, for the first quarter 2009 compared to non-GAAP net income of $20.6 million, or $0.36 per diluted share for the same period in 2008. Net income for the first quarter of 2009 was primarily driven by higher Nexavar sales offset by the company’s expanded clinical development efforts, increased commercial costs to support the brand and lower investment income due to current macroeconomic conditions. On a GAAP basis Onyx reported net income of $4.1 million, or $0.07 per diluted share, for the first quarter 2009 compared to net income of $15.4 million, or $0.27 per diluted share, in the same period in 2008. A description of the non-GAAP calculations and reconciliation to comparable GAAP measures are provided in the accompanying table entitled “Reconciliation of GAAP to Non-GAAP Net Income.”

“Onyx has established a strong foundation for continued success. Our profitable sales-driven business, outstanding financial strength and broad development program differentiate the company and position us well for the future,” said N. Anthony Coles, M.D., president and chief executive officer of Onyx. “We remain focused on maximizing the opportunities we have ahead of us, which include supporting important new Nexavar clinical trials, as well as investing in our pipeline.”

Revenue from Collaboration Agreement

For the first quarter 2009, Onyx reported revenue from its Nexavar collaboration agreement of $53.7 million compared to $48.9 million for the same period in 2008. The 10% increase in revenue from collaboration agreement between periods resulted from an increase in Nexavar sales and royalty revenue, partially offset by an increase in Nexavar commercial expenses.

Operating Expenses

Onyx recorded research and development expenses of $28.8 million in the first quarter 2009, compared to $18.6 million for the same period in 2008. Higher research and development expenses in the first quarter 2009 were primarily due to planned increases in the development program for Nexavar across additional tumor types, such as colorectal cancer and adjuvant liver cancer, and Onyx’s costs to further develop ONX 0801. Research and development expenses included $0.7 million and $0.6 million of employee stock-based compensation expense for the first quarter of 2009 and 2008, respectively. Selling, general and administrative expenses were $22.0 million in the first quarter 2009, compared to $19.8 million for the same period in 2008. Higher selling, general and administrative expenses were

Onyx Reports First Quarter 2009 Financial Results
May 6, 2009
Page 2

primarily due to increased marketing and employee-related expenses to support Nexavar, as well as increased employee-related expenses to support Onyx’s growth. Selling, general and administrative expenses included $3.4 million and $4.6 million of employee stock-based compensation expense for the first quarter 2009 and 2008, respectively.

Investment Income

Investment income was $1.1 million for the first quarter of 2009, a decrease of $4.2 million from $5.3 million in the same period in 2008. The decrease was primarily due to lower effective interest rates as a result of market conditions as well as a change in the asset allocation of our investment portfolio.

Cash, Cash Equivalents and Marketable Securities

At March 31, 2009, cash, cash equivalents, and current and noncurrent marketable securities were $467.1 million, compared to $458.0 million at December 31, 2008. This increase was primarily due to cash provided by operations.

Management Conference Call Today

Onyx will host a teleconference and webcast to provide a general business overview and discuss financial results. The event will begin at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) on May 6, 2009. The live webcast will be available at:

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

or by dialing 847-413-3238 and using the passcode 24308683. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3044 and using the passcode 24308683 later in the day. The replay will be available through June 5, 2009.

About Onyx Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, is developing and marketing Nexavar^® (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 a variety of tumor types. For more information about Onyx, visit http://www.onyx-pharm.com.

Nexavar^® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals.

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, 2008, 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 Reports First Quarter 2009 Financial Results
May 6, 2009
Page 3

ONYX PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(unaudited)

	Three Months Ended
	March 31,
	2009		2008
Revenue:
Revenue from collaboration agreement	$	53,717	$	48,855
Total operating revenue	$	53,717	$	48,855
Operating expenses:
Research and development (1)		28,820		18,555
Selling, general and administrative (1)		21,953		19,844
Total operating expenses		50,773		38,399
Income from operations		2,944		10,456
Investment income, net		1,121		5,271
Provision for income taxes		—		309
Net income	$	4,065	$	15,418
Net income per share:
Basic	$	0.07	$	0.28
Diluted	$	0.07	$	0.27
Shares used in computing net income per share:
Basic		56,715		55,388
Diluted		57,197		56,566
(1) Includes employee stock-based compensation charges of:
Research and development	$	652	$	580
Selling, general, and administrative		3,351		4,636
Total employee stock-based compensation	$	4,003	$	5,216

ONYX PHARMACEUTICALS, INC.
CALCULATION OF REVENUE FROM COLLABORATION AGREEMENT
(In thousands, unaudited)

	Three Months Ended
	March 31,
	2009		2008
Nexavar product revenue, net (as recorded by Bayer)	$	178,069	$	151,896
Revenue subject to profit sharing (as recorded by Bayer)	$	166,974	$	151,896
Combined cost of goods sold, distribution, selling, general and administrative expenses		71,879		62,703
Combined commercial collaboration profit	$	95,095	$	89,193
Onyx’s share of commercial collaboration profit	$	47,547	$	44,597
Reimbursement of Onyx’s shared marketing expenses		5,393		4,258
Royalty revenue		777		—
Revenue from collaboration agreement	$	53,717	$	48,855

Onyx Reports First Quarter 2009 Financial Results
May 6, 2009
Page 4

ONYX PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(In thousands)

	Mar. 31,		Dec. 31,
	2009		2008
	(unaudited)		(2)
Assets
Cash, cash equivalents and marketable securities	$	430,653	$	418,424
Other current assets		44,729		43,635
Total current assets		475,382		462,059
Property and equipment, net		2,941		3,363
Marketable securities, non-current		36,456		39,622
Other assets		4,717		4,723
Total assets	$	519,496	$	509,767
Liabilities and stockholders’ equity
Current liabilities		27,957		33,304
Other long-term liabilities		1,190		1,263
Stockholders’ equity		490,349		475,200
Total liabilities and stockholders’ equity	$	519,496	$	509,767

(2) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year-ended December 31, 2008.

Onyx Reports First Quarter 2009 Financial Results
May 6, 2009
Page 5

ONYX PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME
(In thousands, except per share amounts)
(unaudited)

	Three Months Ended
	March 31,
	2009		2008
GAAP net income	$	4,065	$	15,418
Non-GAAP adjustments:
Employee stock-based compensation under FAS 123R (4)		4,003		5,216
Non-GAAP net income (3)	$	8,068	$	20,634
GAAP diluted net income per share	$	0.07	$	0.27
Non-GAAP adjustments:
Employee stock-based compensation under FAS 123R (4)		0.07		0.09
Non-GAAP diluted net income per share (3)	$	0.14	$	0.36
Diluted shares		57,197		56,566

(3)

This press release includes the following non-GAAP financial measures: non-GAAP net income and non-GAAP diluted net income per share. The foregoing table reconciles these non-GAAP measures to the most comparable financial measures calculated in accordance with GAAP.

Our management uses these non-GAAP financial measures to monitor and evaluate our operating results and trends on an on-going basis and internally for operating, budgeting and financial planning purposes. Our management believes the non-GAAP information is useful for investors by offering them the ability to better identify trends in our business and better understand how management evaluates our business. These non-GAAP measures have limitations, however, because they do not include all items of income and expense that affect Onyx. These non-GAAP financial measures that our management uses are not prepared in accordance with, and should not be considered in isolation of, or as an alternative to, measurements required by GAAP.

(4) Employee stock-based compensation under FAS 123R: Our management excludes the effects of employee stock-based compensation because of varying available valuation methodologies, subjective assumptions and the variety of award types; such exclusion facilitates comparisons of our operating results to our peer companies.

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