EX-99.1 2 f56515exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
(ONYX LOGO)
Contact:
Julie Wood
Vice President, Investor Relations
510-597-6505
Onyx Pharmaceuticals Reports Second Quarter 2010 Financial Results;
Nexavar Global Net Sales Increase 17% vs. Prior Year
Non-GAAP Net Income of $2.9 Million and EPS of $0.05
EMERYVILLE, CA — August 4, 2010 — Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today reported its financial results for the second quarter 2010. Global Nexavar net sales as reported by Onyx’s collaborator Bayer HealthCare Pharmaceuticals Inc., or Bayer, were $236.1 million for the second quarter 2010, a 17% increase compared to $201.0 million in the same period in 2009. 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 90 countries worldwide.
Onyx reported non-GAAP net income of $2.9 million, or $0.05 per diluted share, for the second quarter 2010 compared to non-GAAP net income of $15.3 million, or $0.27 per diluted share, for the same period in 2009. Non-GAAP net income excludes adjustments to contingent consideration expense in connection with our acquisition of Proteolix, Inc., or Proteolix; employee stock-based compensation expense and non-cash imputed interest expense related to the application of Accounting Standards Codification (“ASC”) Subtopic 470-20. Non-GAAP net income for the second quarter 2010 reflected an increase in the commercial profit from the Nexavar collaboration, offset by an increase in research and development expenses primarily due to the development efforts for carfilzomib, and by interest expense on the convertible senior notes issued in August 2009.
On a GAAP basis, Onyx reported a net loss of $97.2 million, or $1.55 per diluted share, for the second quarter 2010 compared to net income of $9.4 million, or $0.16 per diluted share, in the same period in 2009. The GAAP net loss for the second quarter 2010 includes an increase in the non-cash contingent consideration expense based on recent positive carfilzomib data. The change is associated with an increased probability of making the earn-out payments related to the Proteolix acquisition. 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 Income (Loss).”
“With year-over-year Nexavar net sales growth of 17% and healthy quarter-over-quarter growth, our commercially successful business is delivering cash flow and driving the strategic flexibility to maximize our rapidly advancing pipeline,” said N. Anthony Coles, M.D., president and chief executive officer of Onyx. “The strategy to expand our portfolio has proven successful with the recently announced impressive top-line data for carfilzomib. These exciting data have the potential to transform Onyx into a multi-product revenue-driven company with the opportunity to benefit even greater numbers of patients.”
Revenue from Collaboration Agreement
For the second quarter 2010, Onyx reported revenue from its Nexavar collaboration agreement of $68.8 million compared to $60.2 million for the same period in 2009. The increase in revenue from collaboration agreement between periods resulted from higher global net sales of Nexavar.
Operating Expenses
Onyx recorded research and development expenses of $43.3 million in the second quarter 2010, compared to $28.0 million for the same period in 2009. Higher research and development expenses in the second quarter 2010 were primarily due to planned investments to develop carfilzomib. Selling, general and administrative expenses were $26.6 million in the second quarter 2010, compared to $23.5 million for the same period in 2009. Higher selling, general and administrative expenses were primarily due to the timing of shared advertising and promotional costs related to Nexavar incurred by Onyx and due to planned expense increases as a result of the acquisition of Proteolix.

 


 

ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS
AUGUST 4, 2010
PAGE 2
Contingent Consideration Expense
Onyx recorded $92.0 million of non-cash expense in the second quarter 2010 associated with the increase in the fair value of the liability for the potential earn-out payments related to the Proteolix acquisition. The increase in the fair value of the liability consisted of $88.5 million due to an increase in the probability of success and $3.5 million due to the passage of time. The increased probability of success reflects positive preliminary results from the 003-A1 trial, a Phase 2b study of carfilzomib, and the PX-171-006 trial, a Phase 1b study of carfilzomib plus lenalidomide and low-dose dexamethasone, both of which were in patients with relapsed and refractory multiple myeloma.
Interest Expense
Interest expense of $4.8 million for the second quarter 2010 primarily relates to the 4.0% convertible senior notes due 2016 issued in August 2009, and includes non-cash imputed interest expense of $2.2 million as a result of the application of ASC Subtopic 470-20.
Cash, Cash Equivalents and Marketable Securities
On June 30, 2010, cash, cash equivalents, and current and non-current marketable securities were $527.0 million, compared to $587.3 million at December 31, 2009. This excludes restricted cash of $31.6 million and $27.6 million at June 30, 2010 and December 31, 2009, respectively. The decrease is primarily due to a $40.0 million earn-out payment made to former Proteolix stockholders as a result of the achievement of a development milestone and a $20.0 million pre-payment to S*BIO Pte Ltd for research and development expenses related to ONX 0803 and ONX 0805.
Six-Month Results
Nexavar net sales, as recorded by Bayer, were $450.5 million and $379.1 million for the six months ended June 30, 2010 and 2009, respectively. Non-GAAP net income for the six months ended June 30, 2010 was $1.4 million, or $0.02 per diluted share, compared to non-GAAP net income of $23.4 million, or $0.41 per diluted share for the same period in 2009. Non-GAAP net income excludes adjustments to contingent consideration expense in connection with our acquisition of Proteolix; employee stock-based compensation expense and non-cash imputed interest expense related to the application of ASC Subtopic 470-20. A description of the non-GAAP calculations is provided below in the accompanying table entitled “Reconciliation of GAAP to Non-GAAP Net Income (Loss).” For the six months ended June 30, 2010, on a GAAP basis Onyx recorded a net loss of $109.2 million, or $1.75 per diluted share, compared with a net income of $13.4 million, or $0.24 per diluted share, for the same period in 2009.
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 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) on August 4, 2010. The live webcast will be available at:
http://www.onyx-pharm.com/view.cfm/32/Event-Calendar
or by dialing 847-619-6547 and using the passcode 27437891. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3044 and using the passcode 27437891# approximately one hour after the teleconference concludes. The replay will be available through August 18, 2010.
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

 


 

ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS
AUGUST 4, 2010
PAGE 3
carfilzomib, a next-generation 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; competition; failures or delays in our clinical trials; dependence on our collaborative relationship with Bayer; 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; 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; product liability risks; and the anticipated benefits of the acquisition of Proteolix. Reference should be made to Onyx’s Annual Report on Form 10-K for the year ended December 31, 2009 filed with the Securities and Exchange Commission, under the heading “Risk Factors” for a more detailed description of these and other risks, as well as the company’s subsequent quarterly report 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 REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS
AUGUST 4, 2010
PAGE 4
ONYX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2010     2009     2010     2009  
Revenue:
                               
Revenue from collaboration agreement
  $ 68,773     $ 60,219     $ 131,676     $ 113,936  
 
                       
Total operating revenue
    68,773       60,219       131,676       113,936  
Operating expenses:
                               
Research and development (1)
    43,251       28,022       86,826       56,842  
Selling, general and administrative (1)
    26,647       23,507       51,368       45,459  
Contingent consideration
    92,037             95,485        
 
                       
Total operating expenses
    161,935       51,529       233,679       102,301  
 
                       
Income (loss) from operations
    (93,162 )     8,690       (102,003 )     11,635  
Investment income
    780       972       1,569       2,092  
Interest expense
    (4,800 )           (9,525 )      
 
                       
Income (loss) before provision (benefit) for income taxes
    (97,182 )     9,662       (109,959 )     13,727  
Provision (benefit) for income taxes
          288       (732 )     288  
 
                       
Net income (loss)
  $ (97,182 )   $ 9,374     $ (109,227 )   $ 13,439  
 
                       
 
                               
Net income (loss) per share:
                               
Basic
  $ (1.55 )   $ 0.16     $ (1.75 )   $ 0.24  
 
                       
Diluted (2)
  $ (1.55 )   $ 0.16     $ (1.75 )   $ 0.24  
 
                       
 
                               
Computation of diluted shares:
                               
Basic
    62,627       56,890       62,491       56,803  
Dilutive effect of options
          220             375  
 
                       
Diluted (2)
    62,627       57,110       62,491       57,178  
 
                       
 
                               
(1)     Includes employee stock-based compensation charges of:
                               
Research and development
  $ 1,104     $ 1,117     $ 2,016     $ 1,769  
Selling, general, and administrative
    4,672       4,842       8,702       8,193  
 
                       
Total employee stock-based compensation
  $ 5,776     $ 5,959     $ 10,718     $ 9,962  
 
                       
(2) Under the “if-converted” method, interest and issuance costs and potential common shares related to the Company’s convertible senior notes were excluded in the computation of diluted per share amounts for the three and six months ended June 30, 2010 because their effect would be anti-dilutive.

 


 

ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS
AUGUST 4, 2010
PAGE 5
ONYX PHARMACEUTICALS, INC.
CALCULATION OF REVENUE FROM COLLABORATION AGREEMENT
(In thousands, unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2010     2009     2010     2009  
Nexavar product revenue, net (as recorded by Bayer)
  $ 236,122     $ 200,983     $ 450,483     $ 379,052  
 
                       
 
                               
Nexavar revenue subject to profit sharing (as recorded by Bayer)
  $ 202,979     $ 181,345     $ 388,846     $ 348,319  
Combined cost of goods sold, distribution, selling, general and administrative expenses
    83,022       74,343       158,720       146,222  
 
                       
Combined collaboration commercial profit
  $ 119,957     $ 107,002     $ 230,126     $ 202,097  
 
                       
Onyx’s share of collaboration commercial profit
  $ 59,978     $ 53,501     $ 115,063     $ 101,049  
Reimbursement of Onyx’s shared marketing expenses
    6,475       5,344       12,299       10,736  
Royalty revenue
    2,320       1,374       4,314       2,151  
 
                       
Revenue from collaboration agreement
  $ 68,773     $ 60,219     $ 131,676     $ 113,936  
 
                       

 


 

ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS
AUGUST 4, 2010
PAGE 6
ONYX PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME (LOSS)
(In thousands, except per share amounts)
(unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2010     2009     2010     2009  
GAAP net income (loss)
  $ (97,182 )   $ 9,374     $ (109,227 )   $ 13,439  
Non-GAAP adjustments:
                               
Contingent consideration
    92,037             95,485        
Employee stock-based compensation
    5,776       5,959       10,718       9,962  
Imputed interest related to the convertible senior notes due 2016
    2,222             4,379        
 
                       
Non-GAAP net income (3)
  $ 2,853     $ 15,333     $ 1,355     $ 23,401  
 
                       
 
                               
Computation of non-GAAP diluted shares
                               
Basic shares
    62,627       56,890       62,491       56,803  
Dilutive effect of options
    173       220       222       375  
 
                       
Non-GAAP diluted shares (4)
    62,800       57,110       62,713       57,178  
 
                       
 
                               
Non-GAAP net income per share
  $ 0.05     $ 0.27     $ 0.02     $ 0.41  
Non-GAAP net income per share — diluted (4)
  $ 0.05     $ 0.27     $ 0.02     $ 0.41  
(3)   This press release includes the following non-GAAP financial measures: non-GAAP net income, non-GAAP diluted shares and non-GAAP net income per share. The foregoing table reconciles these non-GAAP measures to the most comparable financial measures calculated in accordance with GAAP.
 
    Onyx management uses these non-GAAP financial measures to monitor and evaluate our operating results and trends on an on-going basis and internally for operating, budgeting and financial planning purposes. Onyx management believes the non-GAAP information is useful for investors by offering them the ability to better identify trends in our business and better understand how management evaluates the business. These non-GAAP measures have limitations, however, because they do not include all items of income and expense that affect Onyx. These non-GAAP financial measures that management uses are not prepared in accordance with, and should not be considered in isolation of, or an as alternative to, measurements required by GAAP.
 
    These non-GAAP financial measures exclude the following items from GAAP net income (loss) and diluted per share amounts:
Contingent consideration expense: The effects of contingent consideration expense are excluded due to the nature of this charge, which is related to the change in fair value of the liability for contingent consideration in connection with the acquisition of Proteolix; such exclusion facilitates comparisons of Onyx’s operating results to peer companies.
Employee stock-based compensation: The effects of employee stock-based compensation are excluded because of varying available valuation methodologies, subjective assumptions and the variety of award types; such exclusion facilitates comparisons of Onyx’s operating results to peer companies.

 


 

ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS
AUGUST 4, 2010
PAGE 7
Imputed interest related to the convertible senior notes due 2016: The effects of imputed interest related to the convertible senior notes due 2016 are excluded because this expense is non-cash; such exclusion facilitates comparisons of Onyx’s cash operating results to peer companies.
(4)   Under the “if-converted” method, interest and issuance costs and potential common shares related to the Company’s convertible senior notes were excluded in non-GAAP diluted per share amounts for the three and six months ended June 30, 2010 because their effect would be anti-dilutive.
ONYX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
                 
    June 30,     December 31,  
    2010     2009  
    (unaudited)     (5)  
Assets
               
Cash, cash equivalents and current marketable securities
  $ 488,334     $ 550,108  
Other current assets
    92,592       88,615  
 
           
Total current assets
    580,926       638,723  
Marketable securities, non-current
    38,675       37,174  
Property and equipment, net
    6,416       7,473  
Intangible assets — in-process research and development
    438,800       438,800  
Goodwill
    193,675       193,675  
Other assets
    27,816       8,835  
 
           
Total assets
  $ 1,286,308     $ 1,324,680  
 
           
Liabilities and stockholders’ equity
               
Current liabilities
  $ 64,692     $ 107,778  
Convertible senior notes due 2016
    148,048       143,669  
Liability for contingent consideration, non-current
    256,013       160,528  
Deferred tax liability
    157,090       157,090  
Other long-term liabilities
    4,628       5,059  
Stockholders’ equity
    655,837       750,556  
 
           
Total liabilities and stockholders’ equity
  $ 1,286,308     $ 1,324,680  
 
           
(5)   Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year-ended December 31, 2009.