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Onyx Pharmaceuticals Reports Record Full Year and Fourth Quarter 2009 Financial Results

Global Nexavar Sales Increases 24% Over 2008
Company Achieves Second Year of Profitability and Non-GAAP Net Income of $54.4 Million in 2009


Emeryville, CA. — Feb. 23, 2010

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today reported its financial results for the full year and fourth quarter 2009. Global Nexavar net sales as recorded by Onyx’s collaborator, Bayer HealthCare Pharmaceuticals, Inc., or Bayer, were $843.5 million for the full year 2009 and $235.2 million for the fourth quarter 2009 compared to $677.8 million and $176.5 million for the same periods 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, Japan and other territories.

“2009 was a transformational year for Onyx as we continued to grow Nexavar sales, increased cash flow from operations, augmented our cash reserves, delivered promising clinical data in breast cancer, and created a broad and balanced portfolio of compelling compounds,” said N. Anthony Coles, M.D., president and chief executive officer of Onyx. “As a result, Onyx has successfully established its position as an emerging oncology leader. With a 24% increase in annual Nexavar sales and growing commercial margins, it is this outstanding performance that has enabled us to invest in our future with an expanding number of pipeline products to improve the lives of patients and create additional value for shareholders.”

Onyx reported GAAP net income of $16.2 million, or $0.27 per diluted share, for the full year 2009 compared with net income of $1.9 million, or $0.03 per diluted share, for the same period in 2008. For the fourth quarter 2009 Onyx reported a GAAP net loss of $5.5 million, or $0.09 per diluted share, compared to a net loss of $30.2 million, or $0.53 per diluted share, in the same period in 2008. Onyx reported non-GAAP net income of $54.4 million, or $0.89 per diluted share, for the full year 2009 compared to non-GAAP net income of $54.8 million, or $0.97 per diluted share, for the same period in 2008. For the fourth quarter 2009, Onyx reported non-GAAP net income of $8.8 million, or $0.14 per diluted share, compared to $8.9 million, or $0.16 per diluted share for the same period in 2008. Non-GAAP net income excludes, among other things, employee stock-based compensation expense, transaction costs related to Onyx’s acquisition of Proteolix, Inc. in November 2009 and upfront and milestone payments. For a complete description of the items excluded to arrive at non-GAAP net income and a reconciliation to comparable GAAP measures, refer to the accompanying Reconciliation of GAAP to Non-GAAP Net Income (Loss) provided below.

Revenue from Collaboration Agreement
For the full year and fourth quarter 2009, Onyx reported revenue from its Nexavar collaboration agreement of $250.4 million and $67.3 million, respectively, compared to $194.3 million and $49.7 million for the same periods in 2008. The increase in revenue from collaboration agreement between periods is due to an increase in Nexavar revenue recognized by Bayer and higher royalty revenue, partially offset by an increase in commercial expenses related to Nexavar.

Operating Expenses
Onyx recorded research and development expenses of $128.5 million for the full year 2009 and $36.0 million for the fourth quarter 2009, compared to $123.7 million and $59.9 million for the same periods in 2008. Research and development expenses for the full year 2009 increased compared to 2008 primarily due to increases in the development program for Nexavar across additional tumor types, such as thyroid, breast, colorectal and adjuvant liver cancer; expenses related to the development of carfilzomib following the acquisition of Proteolix; and Onyx’s costs to further develop ONX 0801, including a milestone payment of $7.0 million to BTG International Limited (BTG). In 2008, research and development expenses included payments totaling $33.8 million made to S*BIO Pte Ltd (S*BIO) under a development collaboration, option and license agreement and to BTG under a development and license agreement.

Onyx recorded selling, general and administrative expenses of $101.1 million in the full year 2009 and $32.2 million in the fourth quarter 2009, compared to $81.0 million and $22.0 million for the same periods in 2008. Higher selling, general and administrative expenses were primarily due to headcount-related expenses to support Onyx’s growth and to legal and acquisition-related costs.

Onyx recorded $1.5 million of non-cash expense in the fourth quarter of 2009 associated with the increase in the fair value of the liability for contingent consideration related to the acquisition of Proteolix.

Investment Income
For the full year and fourth quarter 2009, investment income was $4.0 million and $0.9 million, respectively, compared to $12.7 million and $2.0 million for the same periods 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 Onyx’s investment portfolio.

Interest Expense
Onyx recorded interest expense of $6.9 million and $4.6 million for the full year and fourth quarter 2009, related to the 4.0% convertible senior notes due 2016 issued in August 2009, which includes non-cash imputed interest expense of $3.1 million and $2.1 million for the same periods.

Cash, Cash Equivalents and Marketable Securities
At December 31, 2009, cash, cash equivalents, and current and noncurrent marketable securities were $587.3 million, compared to $458.0 million at December 31, 2008. This increase was primarily due to net proceeds of debt and equity financings in August 2009 and cash generated from operations, offset by cash paid in connection with the Proteolix acquisition.

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 February 23, 2010. The live webcast will be available at:

http://www.onyx-pharm.com/view.cfm/32/Event-Calendar

or by dialing 847-619-6547 and using the passcode 26379728. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3044 and using the passcode 26379728 approximately one hour after the teleconference concludes. The replay will be available through March 9, 2010.

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, Inc., is developing and marketing Nexavar ® (sorafenib) tablets, a small molecule drug that 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. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a next-generation proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors, and ONX 0801, a targeted alpha-folate inhibitor, currently in Phase 1 testing. 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, the timing, progress and results of clinical development, regulatory filings and actions, the creation of opportunities for value creation and the integration of the operations and assets of Proteolix. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: Nexavar being our only approved product; competition; failures or delays in our clinical trials; dependence on our collaborative relationship with Bayer; market acceptance and the rate of adoption of our products; pharmaceutical pricing and reimbursement pressures; serious adverse side effects, if they are associated with Nexavar; government regulation; possible failure to realize the anticipated benefits of business acquisitions or strategic investments; protection of our intellectual property; the indebtedness incurred through the sale of our 4.0% convertible senior notes due 2016; product liability risks; and the anticipated benefits of the acquisition of Proteolix. Reference should be made to Onyx’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission, under the heading “Risk Factors” for a more detailed description of these and other risks, 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.

 

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