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8-K - FORM 8-K - ONYX PHARMACEUTICALS INCf59716e8vk.htm
Exhibit 99.1
(ONYX PHARMACEUTICALS LOGO)
Contact:
Traci McCarty
Senior Director, Investor Relations
650-266-2398
Onyx Pharmaceuticals Reports Second Quarter 2011 Financial Results
Global Nexavar Sales Increase to $245.7 Million
SOUTH SAN FRANCISCO, CA — August 3, 2011 — Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today reported its financial results for the second quarter 2011. Onyx reported a non-GAAP net loss of $27.2 million, or $0.43 per diluted share, for the second quarter 2011 compared to a non-GAAP net income of $2.9 million, or $0.05 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; lease termination exit costs, 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.
“The quarter was marked by continued progress across our product portfolio,” said N. Anthony Coles, M.D., president and chief executive officer of Onyx. “Approved for the treatment of liver cancer and kidney cancer, Nexavar delivered another quarter of solid operating performance driven by strong growth in the Asia Pacific region. With five late-stage clinical trials expected to read-out by the end of 2012, Nexavar is poised to penetrate existing and new markets.” Dr Coles continued, “Our Phase 3 confirmatory trials with carfilzomib, ASPIRE and FOCUS, are well underway. Importantly, we are ramping up preparation for the commercialization of carfilzomib, in anticipation of a potential U.S. approval next year.”
On a GAAP basis, Onyx reported a net loss of $54.5 million, or $0.86 per diluted share, for the second quarter 2011 compared to a net loss of $97.2 million, or $1.55 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 Income (Loss).”
Revenue from Collaboration Agreement
Global Nexavar net sales, which are recorded by Onyx’s collaborator, Bayer HealthCare Pharmaceuticals Inc., or Bayer, were $245.7 million for the second quarter 2011, an increase of $9.6 million, or 4%, compared to $236.1 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 second quarter 2011, Onyx reported total revenue from collaboration agreement of $68.0 million compared to $68.8 million for the same period in 2010.

 


 

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Operating Expenses
Onyx recorded research and development expenses of $63.0 million in the second quarter 2011 compared to $43.3 million for the same period in 2010. The 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 $38.2 million in the second quarter 2011, compared to $26.6 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, and selected pre-launch spending for carfilzomib.
Onyx recorded $5.8 million of non-cash contingent consideration expense in the second 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.
As a result of consolidation of its facilities, Onyx ceased the use of facilities it previously occupied in Emeryville and in South San Francisco, California. In connection with the exits of these facilities, the Company recorded $10.7 million of non-cash lease termination exit costs.
Interest Expense
Interest expense of $5.0 million for the second 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 $4.9 million as a result of the application of ASC 470-20.
Cash, Cash Equivalents and Marketable Securities
On June 30, 2011, cash, cash equivalents, and current and non-current marketable securities were $550.6 million compared to $577.9 million at December 31, 2010. This excludes restricted cash of $31.9 million at December 31, 2010.
Six-Month Results
Nexavar net sales, as recorded by Bayer, were $481.1 million and $450.5 million for the six months ended June 30, 2011 and 2010, respectively. Non-GAAP net loss for the six months ended June 30, 2011 was $41.4 million, or $0.66 per diluted share, compared to non-GAAP net income of $1.4 million, or $0.02 per diluted share for the same period in 2010. Non-GAAP net income excludes employee stock-based compensation expense, non-cash imputed interest expense related to the application of ASC Subtopic 470-20, non-cash items related to the advance funding and impairment of equity investment in S*BIO, lease termination exit costs and adjustments to contingent consideration expense in connection with our acquisition of Proteolix. 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, 2011, on a GAAP basis Onyx recorded a net loss of $103.7 million, or $1.64 per diluted share, compared with a net loss of $109.2 million, or $1.75 per diluted share, for the same period in 2010.
Management Conference Call Today
Onyx will host a webcast and teleconference with management to discuss second quarter 2011 financial results, as well as provide a general business, overview on Wednesday, August 3, 2011, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Financial results for the second quarter ended June 30, 2011 will be released earlier that day.
Interested parties may access a live webcast of the presentation on the company’s website at:
http://www.onyx-pharm.com/investors/event-calendar

 


 

ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS
August 3, 2011
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or by dialing 847-585-4405 and using the passcode 30130102#. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3042 and using the passcode 30130102# approximately one hour after the teleconference concludes. The replay will be available through August 17, 2011.
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer and other serious diseases. The company is focused on developing novel medicines that target key molecular pathways. 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, 2010 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.
(See attached tables)

 


 

ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS
August 3, 2011
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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,  
    2011     2010     2011     2010  
Revenue:
                               
Revenue from collaboration agreement
  $ 67,956     $ 68,773     $ 135,101     $ 131,676  
 
                       
Total revenue
    67,956       68,773       135,101       131,676  
Operating expenses:
                               
Research and development (1) (2)
    63,045       43,251       125,538       86,826  
Selling, general and administrative (1)
    38,236       26,647       72,707       51,368  
Contingent consideration
    5,755       92,037       17,250       95,485  
Lease termination exit costs
    10,727             10,727        
 
                       
Total operating expenses
    117,763       161,935       226,222       233,679  
 
                       
Loss from operations
    (49,807 )     (93,162 )     (91,121 )     (102,003 )
Investment income
    645       780       1,293       1,569  
Interest expense
    (5,041 )     (4,800 )     (10,042 )     (9,525 )
Other expense (3)
    (340 )           (3,801 )      
 
                       
Loss before provision (benefit) for income taxes
    (54,543 )     (97,182 )     (103,671 )     (109,959 )
Provision (benefit) for income taxes
                32       (732 )
 
                       
Net loss
  $ (54,543 )   $ (97,182 )   $ (103,703 )   $ (109,227 )
 
                       
 
                               
Net loss per share:
                               
Basic
  $ (0.86 )   $ (1.55 )   $ (1.64 )   $ (1.75 )
 
                       
Diluted (4)
  $ (0.86 )   $ (1.55 )   $ (1.64 )   $ (1.75 )
 
                       
 
                               
Computation of diluted shares:
                               
Basic
    63,415       62,627       63,212       62,491  
Dilutive effect of options
                       
 
                       
Diluted (4)
    63,415       62,627       63,212       62,491  
 
                       
 
                               
(1) Includes employee stock-based compensation charges of:
                               
Research and development
  $ 1,893     $ 1,104     $ 2,819     $ 2,016  
Selling, general, and administrative
    6,451       4,672       10,880       8,702  
 
                       
Total employee stock-based compensation
  $ 8,344     $ 5,776     $ 13,699     $ 10,718  
 
                       
 
(2)   Includes a $12.7 million non-cash expense related to the unamortized balance of funding provided to S*BIO which was recorded in the first quarter of 2011.
 
(3)   Includes a $3.0 million impairment charge which reflects the reassessment of the fair value of Onyx’s equity investment in S*BIO during the first quarter of 2011.
 
(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 the computation of diluted per share amounts for the three and six months ended June 30, 2011 and 2010 because their effect would be anti-dilutive.

 


 

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August 3, 2011
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ONYX PHARMACEUTICALS, INC.
CALCULATION OF REVENUE FROM COLLABORATION AGREEMENT
(In thousands, unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2011     2010     2011     2010  
Nexavar product revenue, net (as recorded by Bayer)
  $ 245,665     $ 236,122     $ 481,132     $ 450,483  
 
                       
 
                               
Nexavar revenue subject to profit sharing (as recorded by Bayer)
  $ 206,600     $ 202,979     $ 399,770     $ 388,846  
Combined cost of goods sold, distribution, selling, general and administrative expenses
    89,530       83,022       163,540       158,720  
 
                       
Combined collaboration commercial profit
  $ 117,070     $ 119,957     $ 236,230     $ 230,126  
 
                       
Onyx’s share of collaboration commercial profit
  $ 58,535     $ 59,978     $ 118,115     $ 115,063  
Reimbursement of Onyx’s shared marketing expenses
    6,687       6,475       11,291       12,299  
Royalty revenue
    2,734       2,320       5,695       4,314  
 
                       
Revenue from collaboration agreement
  $ 67,956     $ 68,773     $ 135,101     $ 131,676  
 
                       

 


 

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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,  
    2011     2010     2011     2010  
 
                               
GAAP net (loss)
  $ (54,543 )   $ (97,182 )   $ (103,703 )   $ (109,227 )
Non-GAAP adjustments:
                               
Contingent consideration
    5,755       92,037       17,250       95,485  
Employee stock-based compensation
    8,344       5,776       13,699       10,718  
Imputed interest related to the convertible senior notes due 2016
    2,509       2,222       4,944       4,379  
Advance funding to S*BIO
                12,666        
Impairment of equity investment in S*BIO
                3,000        
Lease termination exit costs
    10,727             10,727        
 
                       
Non-GAAP net (loss) / income (5)
  $ (27,208 )   $ 2,853     $ (41,417 )   $ 1,355  
 
                       
 
                               
Computation of non-GAAP diluted net (loss) / income
                               
 
                       
Non-GAAP net (loss) / income (5)
  $ (27,208 )   $ 2,853     $ (41,417 )   $ 1,355  
 
                       
Add:
                               
Interest and issuance costs related to dilutive convertible senior notes (6)
                       
 
                       
Non-GAAP net (loss) / income — diluted (5)
  $ (27,208 )   $ 2,853     $ (41,417 )   $ 1,355  
 
                       
 
                               
Computation of non-GAAP diluted shares
                               
Basic shares
    63,415       62,627       63,212       62,491  
Dilutive effect of convertible senior notes (6)
          173             222  
 
                       
Non-GAAP diluted shares (5)
    63,415       62,800       63,212       62,713  
 
                       
 
                               
Non-GAAP net (loss) / income per share (5)
  $ (0.43 )   $ 0.05     $ (0.66 )   $ 0.02  
Non-GAAP net (loss) / income per share — diluted (5)
  $ (0.43 )   $ 0.05     $ (0.66 )   $ 0.02  
 
(5)   This press release includes the following non-GAAP financial measures: non-GAAP net loss, non-GAAP net loss — diluted, non-GAAP net loss per share, and non-GAAP net loss per share — diluted. 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 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.
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

 


 

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comparisons of Onyx’s cash operating results to peer companies.
Advance funding to S*BIO and impairment of equity investment in S*BIO: The effects of the termination of the S*BIO collaboration agreement are excluded because they do not relate to the normal and recurring transactions of Onyx’s business; such exclusion allows for a better representation of the ongoing economics of the business, facilitates comparison to peer companies and is reflective of how Onyx management internally manages the business.
Lease termination exit costs: The effects of lease termination exit costs are excluded because they represent non-cash items that relate to Onyx’s exit from facilities it previously occupied in Emeryville and in South San Francisco, California.
 
(6)   Under the “if-converted” method, interest and issuance costs and potential common shares related to the Company’s convertible senior notes were excluded from non-GAAP diluted per share amounts for the three and six months ended June 30, 2011 and 2010 because their effect would be anti-dilutive.

 


 

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August 3, 2011
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ONYX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
                 
    June 30,     December 31,  
    2011     2010  
    (unaudited)     (7)  
Assets
               
Cash, cash equivalents and current marketable securities
  $ 522,542     $ 549,313  
Other current assets
    65,776       95,871  
 
           
Total current assets
    588,318       645,184  
Marketable securities, non-current
    28,053       28,555  
Property and equipment, net
    18,570       10,822  
Intangible assets — in-process research and development
    438,800       438,800  
Goodwill
    193,675       193,675  
Other assets
    18,026       35,599  
 
           
Total assets
  $ 1,285,442     $ 1,352,635  
 
           
 
               
Liabilities and stockholders’ equity
               
Current liabilities
  $ 47,850     $ 72,860  
Convertible senior notes due 2016
    157,645       152,701  
Liability for contingent consideration, non-current
    270,708       253,458  
Deferred tax liability
    157,090       157,090  
Other long-term liabilities
    24,561       18,952  
Lease termination exit costs, non-current
    7,622        
Stockholders’ equity
    619,966       697,574  
 
           
Total liabilities and stockholders’ equity
  $ 1,285,442     $ 1,352,635  
 
           
 
(7)   Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year-ended December 31, 2010.