EMERYVILLE, Calif., Aug. 5 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. today reported its financial results for the three and six months ended June 30, 2008. Onyx reported net income of $4.5 million, or $0.08 per diluted share, for the second quarter of 2008 compared to a net loss of $10.8 million, or $0.22 per diluted share, in the same period in 2007. Excluding employee stock-based compensation expense, non-GAAP net income for the second quarter of 2008 was $8.7 million, or $0.15 per diluted share, compared to a non-GAAP net loss of $7.2 million, or $0.15 per diluted share, in the same period in 2007. A description of the non-GAAP calculations is provided below in the accompanying Reconciliation of GAAP to Non-GAAP Net Income.
Global Nexavar net sales as reported by Bayer HealthCare Pharmaceuticals, Inc., or Bayer, were $168.5 million for the quarter ended June 30, 2008, a 107% increase over the $81.3 million reported in the same period in 2007. Onyx with its collaborator, Bayer, is marketing and developing Nexavar(R) (sorafenib) tablets, an anticancer therapy currently approved for the treatment of liver cancer and advanced kidney cancer in the U.S., European Union, and other territories internationally.
“We are pleased with the strong revenues and continued momentum for Nexavar globally with net sales reaching $168.5 million in the second quarter, indicating expanding global demand for the brand. Based on a series of rolling launches worldwide, we expect to see additional growth opportunities for Nexavar, particularly for the treatment of liver cancer,” said Tony Coles, M.D., president and chief executive officer of Onyx. “With the recent approval in China, Nexavar now has the opportunity to help patients in a country where liver cancer claims hundreds of thousands of lives annually. Additionally, last month we were pleased to have the results of the pivotal Phase 3 liver cancer study for Nexavar published in The New England Journal of Medicine, reaching an unprecedented number of new physicians around the world.”
Dr. Coles added, “Simultaneous with our sales achievements this quarter, we continue to make focused investments aimed at maximizing both the near-term and long-term value of this important oncology agent. This includes investing in expanded commercial capabilities to support the liver cancer indication, as well as, continuing to support a robust development program to identify new opportunities for the use of Nexavar and to drive our growth strategy for the brand.”
Net Revenue from Unconsolidated Joint Business
For the quarter ended June 30, 2008, Onyx reported net revenue from unconsolidated joint business of $30.2 million compared to $7.5 million for the same period in 2007. The increase in net revenue from unconsolidated joint business over prior year is due to increases in Nexavar revenue recognized by Bayer and royalty revenue offset by the increase in combined commercial and research and development expenses for Nexavar. The calculation of this line item is shown in the table following the Condensed Statement of Operations.
Operating Expenses
In the second quarter of 2008, Onyx recorded research and development expenses of $8.6 million, an increase of $2.2 million over the second quarter of 2007. The increase in expenses incurred in the second quarter of 2008 was primarily due to higher costs incurred for the breast cancer program. Research and development expenses included $0.8 million of employee stock-based compensation for the second quarter of 2008 compared to $0.7 million for the second quarter of 2007.
In the second quarter of 2008, selling, general and administrative expenses were $19.8 million, an increase of $4.1 million over the second quarter of 2007. The increase in selling, general and administrative expenses was primarily due to increased marketing and employee-related expenses to support Nexavar. Selling, general and administrative expenses included $3.4 million of employee stock-based compensation in the second quarter of 2008 compared to $2.9 million for the second quarter of 2007.
Cash, Cash Equivalents and Marketable Securities
As of June 30, 2008, the company had cash, cash equivalents, and current and non-current marketable securities of $471.2 million compared to $469.7 million at December 31, 2007. This increase was primarily due to cash provided by operations in the first half of 2008.
Six-Month Results
For the six months ended June 30, 2008, Onyx recorded net income of $19.9 million, or $0.35 per diluted share, compared with a net loss of $23.0 million, or $0.49 per diluted share, for the same period in 2007. Nexavar net sales, as recorded by Bayer, were $320.4 million and $142.2 million for the six months ended June 30, 2008 and 2007, respectively. Excluding employee stock-based compensation expense, non-GAAP net income for the six months ended June 30, 2008 was $29.4 million, or $0.52 per diluted share, compared to a non-GAAP net loss of $16.4 million, or $0.35 per diluted share for the same period in 2007. A description of the non-GAAP calculations is provided below in the accompanying Reconciliation of GAAP to Non-GAAP Net Income.
Conference Call with Management Today
Onyx’s management will host a teleconference and web cast to provide a general business overview and discuss second quarter 2008 financial results. The event will begin at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) on August 5, 2008. Interested parties may access a live web cast of the presentation on our website at:
http://www.onyx-pharm.com/wt/page/event_calendar
or by dialing 847-413-3235 and using the passcode 22274059. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3044 and using the passcode 22274059 approximately one hour after the teleconference concludes. The replay will be available through September 4, 2008.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer by changing the way cancer is treated(TM). The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar(R) (sorafenib) tablets, a small molecule drug. Nexavar is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in non-small cell lung cancer, melanoma, breast cancer and other cancers. For more information about Onyx, visit the company’s website at: http://www.onyx-pharm.com.
Nexavar(R) (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 and the timing, progress and results of clinical development, regulatory filings and actions. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx’s Annual Report on Form 10-K for the year ended December 31, 2007, filed with the Securities and Exchange Commission under the heading “Risk Factors” for a more detailed description of such factors, 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.
CONTACT: Julie Wood, Vice President, Investor Relations, +1-510-597-6505,
or Greg W. Schafer, Chief Financial Officer, +1-510-597-6684, both of Onyx
Pharmaceuticals, Inc.
Web site: http://www.onyx-pharm.com/
