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IA: Sales of Onyx Pharmaceuticals' (ONXX) Nexevar.

Nexavar Global Sales Reach Blockbuster Status; Increasing 8% to $1.008 Billion for 2011

South San Francisco, CA. — Feb. 22, 2012

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today reported its financial results for the full year and fourth quarter 2011. Onyx reported non-GAAP net income of $42.0 million, or $0.66 per diluted share, for the full year 2011 compared to non-GAAP net income of $39.2 million, or $0.63 per diluted share, for the same period in 2010. Onyx reported a non-GAAP net income of $102.8 million, or $1.50 per diluted share, for the fourth quarter 2011 compared to non-GAAP net loss of $17.4 million, or $0.28 per diluted share, for the same period in 2010.

2011 was a remarkable year, with Nexavar sales growth driven by continued leadership in liver cancer, expansion of our portfolio with regorafenib, and a New Drug Application filing acceptance for carfilzomib,” said N. Anthony Coles, M.D., president and chief executive officer of Onyx. “We begin 2012 well-positioned to advance multiple therapies that could serve even greater numbers of patients with cancer. By the end of this year, we hope to transform Onyx from a company with one product in two types of cancer to as many as three products in seven types of cancer with either Phase 3 data or regulatory approval. Our cash position and the cash flow from Nexavar sales further enable strategic investment in our proteasome inhibitor franchise as we advance our carfilzomib development program across a variety of treatment landscapes for patients with multiple myeloma.”

On a GAAP basis, Onyx reported a net income of $76.1 million, or $1.19 per diluted share, for the full year 2011 compared to net loss of $84.8 million, or $1.35 per diluted share, in the same period in 2010. On a GAAP basis, Onyx reported a net income of $216.7 million, or $3.16 per diluted share, for the fourth quarter 2011 compared to net loss of $17.1 million, or $0.27 per diluted share, in the same period in 2010. A description of the non-GAAP calculations and reconciliation to comparable GAAP measures is provided in the accompanying table entitled “Reconciliation of GAAP to Non-GAAP Net Income (Loss).”

Operating Revenue

Global Nexavar net sales which are recorded by Onyx’s collaborator, Bayer, were $1.008 billion and $276.8 million for the full year and fourth quarter 2011, respectively, an increase of 8% in both periods, compared to $934.0 million and $257.4 million in the same periods in 2010. Onyx and Bayer are marketing and developing Nexavar® (sorafenib) tablets, an anticancer therapy currently approved for the treatment of unresectable liver cancer and advanced kidney cancer in over 100 countries worldwide.


For the full year and fourth quarter 2011, Onyx reported total operating revenue of $447.2 million and $237.0 million, respectively, compared to $324.5 million and $70.0 million for the same periods in 2010. Total operating revenue is comprised of revenue under the Nexavar collaboration agreement and contract revenue from collaborations. Revenue under the Nexavar collaboration agreement was $287.0 million and $76.8 million for the full year and fourth quarter 2011, respectively, compared to $265.4 million primarily and $70.0 million for the same periods in 2010. Contract revenue from collaboration agreement in the fourth quarter 2011 related to the sale of the Nexavar royalty rights in Japan for $160.0 million.

In the third quarter 2010 Onyx recorded license revenue of $59.2 million, reflecting a fee earned as a part of the consideration under the September 2010 exclusive license agreement with Ono Pharmaceutical Co., Ltd.

http://www.onyx.com/view.cfm/588/onyx-pharmaceuticals-reports-full-...

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