For full prescribing information, including BOXED WARNINGS, visit www.stivarga-us.com.
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The Company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the Company's website at www.onyx.com.
Forward-Looking Statements
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 our expected financial results for 2013, the anticipated growth of our business, investments in and launch of Kyprolis, development of our oral proteasome inhibitor oprozomib, global expansion, generation of cash flows from sales of Nexavar, commercial, regulatory, and clinical results and milestones, royalties on Bayer's global net sales and development of Stivarga, promotion of Stivarga in the U.S., overall costs from sales of Kyprolis and our future clinical trials. 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® (sorafenib) tablets, Kyprolis® (carfilzomib) for Injection and Stivarga® (regorafenib) tablets being the only approved products from which we may obtain revenue; competition; failures or delays in our clinical trials or the regulatory process; dependence on our collaborative relationship with Bayer; supply of Nexavar, Stivarga or Kyprolis; market acceptance and the rate of adoption of Nexavar, Stivarga and Kyprolis; pharmaceutical pricing and reimbursement pressures; serious adverse side effects, if they are associated with Nexavar, Stivarga or Kyprolis; 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; and product liability risks. Reference should be made to Onyx's Prospectus Supplement dated January 16, 2013 to Prospectus dated January 15, 2013 filed with the Securities and Exchange Commission (the "Commission") on January 17, 2013, as updated by Onyx's subsequent filings with the Commission, under the heading "Risk Factors" for a more detailed description of these and other risks. 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.
Kyprolis® (carfilzomib) for Injection
Nexavar® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.
Stivarga® (regorafenib) is a Bayer compound being developed by Bayer. Onyx receives a 20% royalty on global net sales in human oncology. Bayer and Onyx are jointly promoting Stivarga in the U.S.
ONYX PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (unaudited) Three Months Ended Year Ended December 31, December 31, -------------------- -------------------- 2012 2011 2012 2011 --------- --------- --------- ---------Revenue:Revenue from collaboration agreement $ 72,936 $ 76,821 $ 288,416 $ 286,963Product revenue 45,319 - 63,955 -Royalty revenue 8,163 - 8,294 -Contract revenue from collaborations 1,500 160,211 1,500 160,211 --------- --------- --------- ---------Total revenue 127,918 237,032 362,165 447,174 --------- --------- --------- ---------Operating expenses:Cost of goods sold (excludes amortization of certain acquired intangible assets) (1) 832 - 1,328 -Research and development (1)(2) 82,572 83,990 325,256 268,060Selling, general and administrative (1) 74,566 52,611 224,164 167,959Contingent consideration expense (benefit) 2,937 (116,663) 69,173 (93,468)Lease termination exit costs - (4,540) - 6,317Intangible asset amortization 5,221 - 9,331 - --------- --------- --------- ---------Total operating expenses 166,128 15,398 629,252 348,868 --------- --------- --------- ---------Income (loss) from operations (38,210) 221,634 (267,087) 98,306Investment income 675 678 2,678 2,405Interest expense (3) (5,659) (5,069) (21,785) (20,224)Other income (expense) (4) (728) (326) 1,638 (4,103) --------- --------- --------- ---------Income (loss) before provision (benefit) for income taxes (43,922) 216,917 (284,556) 76,384Provision (benefit) for income taxes (5) (1,000) 242 (96,769) 274 --------- --------- --------- ---------Net income (loss) $ (42,922) $ 216,675 $(187,787) $ 76,110 ========= ========= ========= =========Net income (loss) per share:Basic $ (0.64) $ 3.40 $ (2.88) $ 1.20 ========= ========= ========= =========Diluted (6) $ (0.64) $ 3.16 $ (2.88) $ 1.19 ========= ========= ========= =========Computation of diluted shares:Basic 67,028 63,700 65,148 63,422Dilutive effect of convertible senior notes - 5,801 - -Dilutive effect of options - 629 - 588 --------- --------- --------- ---------Diluted (6) 67,028 70,130 65,148 64,010 ========= ========= ========= =========
