Onyx Pharmaceuticals Reports First Quarter 2011 Financial Results

Global Nexavar Sales Increase 10% to $235.5 Million

SOUTH SAN FRANCISCO, CA — May 4, 2021 — Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today reported its financial results for the first quarter 2011. Onyx reported a non-GAAP net loss of $14.2 million, or $0.23 per diluted share, for the first quarter 2011 compared to a non-GAAP net loss of $1.5 million, or $0.02 per diluted share, for the same period in 2010. Non-GAAP net loss excludes, among other items, adjustments to contingent consideration expense in connection with Onyx’s acquisition of Proteolix Inc., or Proteolix; employee stock-based compensation expense; non-cash imputed interest expense related to the application of Accounting Standards Codification (“ASC”) 470-20 and charges associated with the restructuring of Onyx’s development, collaboration, option and license agreement with S*BIO Pte Ltd., or S*BIO.

“2011 is a pivotal year of execution and growth for Onyx as we prepare to deliver a number of significant near-term milestones,” said N. Anthony Coles, M.D., president and chief executive officer of Onyx. “The NDA for carfilzomib in relapsed and refractory multiple myeloma is on track for filing; our Phase 3 confirmatory trials, ASPIRE and FOCUS, are enrolling patients; and ONX 0912, our next generation proteasome inhibitor, is expected to advance to Phase 2. Importantly, we are ramping up our preparation for the commercialization of carfilzomib, in anticipation of a potential U.S. launch next year.”

On a GAAP basis, Onyx reported a net loss of $49.2 million, or $0.78 per diluted share, for the first quarter 2011 compared to a net loss of $12.0 million, or $0.19 per diluted share, for 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 Loss.”

Revenue from Collaboration Agreement

Global Nexavar net sales, which are recorded by Onyx’s collaborator, Bayer HealthCare Pharmaceuticals Inc., or Bayer, were $235.5 million for the first quarter 2011, an increase of $21.1 million, or 10%, compared to $214.4 million for the same period 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 first quarter 2011, Onyx reported total revenue from collaboration agreement of $67.1 million compared to $62.9 million for the same period in 2010. The increase in revenue from collaboration agreement between periods resulted primarily from higher net sales of Nexavar.

Operating Expenses

Onyx recorded research and development expenses of $62.5 million in the first quarter 2011 compared to $43.6 million for the same period in 2010. Research and development expense includes a $12.7 million non-cash expense related to the remaining balance of the funding provided to S*BIO in May 2010. The remaining increase in research and development expense was primarily due to investments in the development of carfilzomib, particularly the Phase 3 ASPIRE and FOCUS trials.

Selling, general and administrative expenses were $34.5 million in the first quarter 2011, compared to $24.7 million for the same period in 2010. Higher selling, general and administrative expenses between periods were primarily due to planned increases in employee headcount and related costs, legal costs, pre-launch costs for carfilzomib and increased facilities-related costs.

Onyx recorded $11.5 million of non-cash contingent consideration expense in the first quarter 2011 associated with changes in the fair value of the liability for contingent consideration recorded for the potential milestone payments under the Proteolix acquisition. The increase in the fair value for the first quarter 2011 consisted of $6.1 million due to an increase in the assessed probability of technical and regulatory success (PTRS) and $5.4 million due to the passage of time. The increase in the PTRS was due to the expanded size and change in endpoint of the Phase 3 European clinical trial, referred to as FOCUS or the “011” trial, announced in March 2011.

Interest Expense

Interest expense of $5.0 million for the first quarter 2011 primarily relates to the 4.0% convertible senior notes due 2016 issued in August 2009 and includes non-cash imputed interest expense of $2.4 million as a result of the application of ASC 470-20.

Other Expense

Other expense for the first quarter 2011 primarily consists of a $3.0 million impairment charge which reflects the reassessment of the fair value of Onyx’s equity investment in S*BIO.

Cash, Cash Equivalents and Marketable Securities

On March 31, 2011, cash, cash equivalents, and current and non-current marketable securities were $561.7 million compared to $577.9 million at December 31, 2010. This excludes restricted cash of $31.9 million at December 31, 2010.

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 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) on May 4, 2011. Interested parties may access a live webcast of the presentation on the company’s website at:


or by dialing 888-771-4371 within the U.S. or 847-585-4405 outside the U.S., and using the passcode 29609004#. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3042 and using the passcode 29609004# approximately one hour after the teleconference concludes for both US and ROW. The replay will be available through May 18, 2011.

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 selective 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. ONX 0801, an alpha-folate receptor targeted inhibitor of the thymidylate synthase, and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing. For more information about Onyx, visit the company’s website at www.onyx-pharm.com.

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

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, and the potential expansion of Onyx’s product portfolio. 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; we may never receive marketing approval for carfilzomib; competition; failures or delays in our clinical trials; dependence on our collaborative relationship with Bayer; if approved, we may be unsuccessful in launching, maintaining adequate supply of or obtaining reimbursement for carfilzomib; 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 or carfilzomib; 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 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. 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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