SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 02/21/13 -- Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today reported its financial results for the full year and fourth quarter 2012 and provided a business update.
"This past year was transformational, as Onyx grew from a company with one therapy in two indications to one with three therapies approved in four indications and positive Phase 3 data for another two potential indications," said N. Anthony Coles, M.D., chairman and chief executive officer of Onyx. "We enter 2013 with the architecture for near-term momentum in our business and sustained growth. The successful launch of Kyprolis, Onyx's first wholly-owned product, serves as the foundation of our emerging proteasome inhibitor franchise, and we are committed to investing in a broad Phase 3 clinical development program across all lines of therapy to reach more patients globally. 2013 will be an important year for commercial execution in the United States, while developing select capabilities to expand our business internationally."
Dr. Coles continued, "The second launch of 2012 was Bayer's Stivarga with additional regulatory actions expected this year in the United States, Europe and Japan. Contributions from worldwide sales of Nexavar and royalty revenue from Stivarga provide increasing cash flow to enable the strategic investment in Kyprolis and oprozomib."
Onyx reported total revenue of $362.2 million for the full year 2012 and $127.9 million for the fourth quarter 2012. Onyx reported non-GAAP net loss of $162.9 million, or $2.50 per diluted share, for the full year 2012 and $24.0 million, or $0.36 per diluted share, for the fourth quarter 2012. On a GAAP basis, Onyx reported net loss of $187.8 million, or $2.88 per diluted share, for the full year 2012 and $42.9 million, or $0.64 per diluted share, for the fourth quarter 2012. A description of the non-GAAP calculations and reconciliation to comparable GAAP financial measures is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Financial Measures."
For the full year and fourth quarter of 2012, Onyx reported total revenue of $362.2 million and $127.9 million, respectively, as compared to total revenue of $447.2 million and $237.0 million for the comparable periods in 2011. For the full year and fourth quarter of 2011, total revenue included $160.0 million in contract revenue from collaboration received from the sale of the Japan royalty rights of Nexavar® (sorafenib) tablets.
•Revenue from the Nexavar collaboration agreement for the full year and fourth quarter of 2012 was $288.4 million and $72.9 million, respectively, as compared to $287.0 million and $76.8 million for the comparable periods in 2011. The increase in full year revenue from collaboration is primarily a result of increased Nexavar net sales as recorded by Bayer, excluding Japan, of $861.4 million and $229.1 million for the full year and fourth quarter of 2012, respectively, as compared to $839.9 million and $231.5 million for the full year and fourth quarter of 2011. The increase in full year Nexavar sales was driven by increased sales in the U.S. and demand driven growth in emerging markets including Asia Pacific and Latin America. •Kyprolis® (carfilzomib) for Injection net sales for the full year and fourth quarter of 2012 were $64.0 million and $45.3 million, respectively, representing orders shipped to and received by end customers such as physician offices and hospitals post-approval. The U.S. Food and Drug Administration (FDA) granted accelerated approval of Kyprolis on July 20, 2012. In addition, Onyx recorded deferred revenue of $9.8 million as of December 31, 2012, representing Kyprolis inventory at distributors which has not yet shipped to physician offices and hospitals. •Stivarga® (regorafenib) tablets royalty revenue was $8.3 million and $8.2 million for the full year and fourth quarter of 2012, respectively, following marketing approval by the U.S. FDA on September 27, 2012. Onyx receives a 20% royalty on Bayer's global net sales of Stivarga in human oncology.
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