Annual Nexavar Net Sales Increased 125% to $372 million in 2007; Fourth
Quarter Sales up 96% over same period last year
EMERYVILLE, Calif., Feb. 19 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today reported its financial results for the three and twelve months ended December 31, 2007. Onyx reported a net loss of $11.7 million, or $0.21 per share, for the fourth quarter of 2007 compared to a net loss of $20.7 million, or $0.47 per share, in the same period in the prior year. For the twelve months ended December 31, 2007, Onyx recorded a net loss of $34.2 million, or $0.67 per share, compared with a net loss of $92.7 million, or $2.20 per share, for the same period in 2006.
Nexavar net sales were $124.9 million for the quarter ended December 31, 2007, which represents a 96% increase over the $63.7 million reported in the same period in 2006 and a 19% increase over the $104.6 million reported in the quarter ended September 30, 2007. Nexavar net sales were $371.7 million in 2007, a 125% increase over the $165.0 million reported in 2006. Onyx, with its collaborator, Bayer HealthCare Pharmaceuticals Inc., or Bayer, is marketing and developing Nexavar(R) (sorafenib) tablets, an anticancer therapy currently approved for the treatment of advanced kidney cancer and liver cancer in the U.S., European Union, and other territories internationally. In accordance with Onyx's collaboration agreement with Bayer, Bayer recognizes all revenue from the sale of Nexavar.
"We are pleased with Nexavar's continued commercial growth, generating worldwide net sales of $124.9 million for the fourth quarter and $371.7 million for 2007," said Hollings C. Renton, president, chief executive officer, and chairman of Onyx. "The approvals of Nexavar in liver cancer and advanced kidney cancer reinforce our commitment to invest in Nexavar, both commercially and clinically, to maximize the full value of this proven anticancer agent."
The net loss for the quarter ended December 31, 2007, included employee stock-based compensation expense of $3.9 million, or $0.07 per share. The net loss for the quarter ended December 31, 2006, included employee stock-based compensation expense of $3.2 million, or $0.07 per share.
Net Expense due to (from) Unconsolidated Joint Business
Onyx reports the net expense due to (from) unconsolidated joint business for Nexavar as a single line item within the Statement of Operations. This item consists of Nexavar product revenue and the reimbursement of Onyx and Bayer for each company's shared expenses under the collaboration and is, in effect, the net amount due to or from Bayer to balance the companies' economics under the Nexavar collaboration. According to the terms of the collaboration, the companies share all research and development, marketing, and non-U.S. sales expenses. Onyx and Bayer each bears its own U.S. sales force and medical science liaison expenses. Bayer recognizes all revenue under the Nexavar collaboration and incurs the majority of expenses relating to the development and marketing of Nexavar. The calculation of the net expense due to (from) unconsolidated joint business is shown in the table following the Condensed Statement of Operations. In the fourth quarter of 2007, Onyx reported a net amount due from Bayer of $4.4 million compared to a net amount due to Bayer of $3.8 million for the fourth quarter of 2006. This change was primarily due to an increase in Nexavar revenue recognized by Bayer partially offset by an increase in the combined commercial and research and development expenses for Nexavar.
In the fourth quarter of 2007, Onyx recorded research and development expenses of $5.5 million, a decrease of $1.3 million compared to the fourth quarter of 2006. The decrease in expenses incurred in the fourth quarter of 2007 was primarily due to a reduction in study costs associated with the melanoma program offset by higher costs incurred for the breast cancer program. Research and development expenses included $0.9 million of employee stock-based compensation for the fourth quarter of 2007 and $0.5 million for the fourth quarter of 2006.
In the fourth quarter of 2007, selling, general and administrative expenses were $16.4 million, an increase of $3.3 million as compared to the fourth quarter of 2006. The increase in selling, general and administrative expenses was primarily related to a planned increase in personnel in the commercial and administrative functions to support Nexavar. Selling, general and administrative expenses included $3.0 million of employee stock-based compensation for the fourth quarter of 2007 and $2.7 million for the fourth quarter of 2006.
Cash, Cash Equivalents and Marketable Securities
As of December 31, 2007, the company had cash, cash equivalents, and short and long-term marketable securities of $469.7 million compared to $271.4 million at December 31, 2006. This increase was primarily due to net proceeds from financing activities offset by cash used in operations for the twelve months ended December 31, 2007.
Conference Call with Management Today
Onyx's management will host a teleconference and web cast to provide an update on Nexavar and discuss fourth quarter and full year 2007 financial results. The event will begin at 10:00 a.m. Eastern Time (7:00 a.m. Pacific Time) on February 19, 2008. Interested parties may access a live web cast of the presentation on our website at:
or by dialing 847-413-3238 and using the passcode 20751832. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3044 and using the passcode 20751832 approximately one hour after the teleconference concludes. The replay will be available through March 19, 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 advanced kidney cancer and for the treatment of liver cancer. Additionally, Nexavar is being investigated in several ongoing trials in non-small cell lung cancer, melanoma, breast cancer and other tumor types. 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, 2006,
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
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
Three Months Ended Twelve Months Ended
Dec. 31, Dec. 31,
2007 2006 2007 2006
Total revenue $ - $ - $ - $ 250
Net expense due to (from)
unconsolidated joint business (4,406) 3,768 (32,536) 23,915
Research and development (1) 5,531 6,856 25,413 30,980
Selling, general and
administrative (1) 16,406 13,075 60,546 50,019
Total operating expenses 17,531 23,699 53,423 104,914
Loss from operations (17,531) (23,699) (53,423) (104,664)
Interest income 5,829 2,992 19,256 11,983
Net loss $(11,702) $(20,707) $(34,167) $(92,681)
Net loss per basic share: $ (0.21) $ (0.47) $ (0.67) $ (2.20)
Shares used in computing basic
net loss per share: 55,212 44,441 51,177 42,170
(1) Includes employee stock-based
compensation charges of:
Research and development $ 851 $ 535 $ 2,897 $ 2,545
Selling, general, and
administrative $ 3,010 $ 2,666 $ 11,230 $ 11,496
$ 3,861 $ 3,201 $ 14,127 $ 14,041
ONYX PHARMACEUTICALS, INC.
CALCULATION OF NET EXPENSE DUE (FROM) TO UNCONSOLIDATED JOINT BUSINESS
Three Months Ended Twelve Months Ended
Dec. 31, Dec. 31,
2007 2006 2007 2006
Product revenue, net $124,919 $ 63,652 $371,736 $164,994
Combined cost of goods sold,
distributed, selling, general
and administrative expenses 81,998 49,226 223,682 123,004
Combined research and
development expenses 51,676 41,076 157,383 161,180
Combined collaboration loss $ 8,755 $ 26,650 $ 9,329 $119,190
Onyx's share of collaboration
loss $ 4,377 $ 13,325 $ 4,665 $ 59,595
Reimbursement of Onyx's direct
development and marketing
expenses 8,783 9,557 37,201 35,680
Onyx net expense due to (from)
unconsolidated joint business $ (4,406) $ 3,768 $(32,536) $ 23,915
CONDENSED BALANCE SHEETS
Dec. 31, Dec. 31,
Cash, cash equivalents and marketable
securities $ 469,650 $ 266,958
Other current assets 11,006 12,940
Total current assets 480,656 279,898
Property and equipment, net 3,146 1,478
Other assets 281 4,870
Total assets $ 484,083 $ 286,246
Liabilities and stockholders' equity
Current liabilities 11,441 23,199
Advance from collaboration partner 39,234 40,000
Other long term liabilities 1,171 267
Stockholders' equity 432,237 222,780
Total liabilities and stockholders'
equity $ 484,083 $ 286,246
(2) Derived from the audited financial statements included in the
Company's Annual Report on Form 10-K for the year-ended December 31,
|SOURCE Onyx Pharmaceuticals, Inc.|
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