EX-99.1 2 f38221exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1
ONYX PHARMACEUTICALS REPORTS FOURTH QUARTER
AND TWELVE-MONTH 2007 FINANCIAL RESULTS
Annual Nexavar Net Sales Increased 125% to $372 million in 2007;
Fourth Quarter Sales up 96% over same period last year
EMERYVILLE, CALIF. — February 19, 2008 — 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® (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.
Operating Expenses
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:
http://www.onyx-pharm.com/wt/page/event_calendar
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™. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar® (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: 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 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 by law.
(See attached tables.)

 

 

ONYX PHARMACEUTICALS, INC.
SUMMARY FINANCIAL INFORMATION
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(unaudited)
                                 
    Three Months Ended Dec. 31,     Twelve Months Ended Dec. 31,  
    2007     2006     2007     2006  
Total revenue
   $ —     $ —     $ —     $ 250  
Operating expenses:
                                
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
(In thousands, unaudited)
                                 
    Three Months Ended Dec. 31,     Twelve Months Ended 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  
 
                        

 

 

ONYX PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(In thousands)
                 
    Dec. 31,     Dec. 31,  
    2007     2006  
    (unaudited)     (2)  
Assets
                
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, 2006.

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