-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VGnC5mupVgLd4Wq9WKOapavVN+aiKcnzwPYNrNSlGP3C/LEv9zVUCjJWUyvxJI3Y C8eOFjMZZwGW8l/YCKzATw== 0000950134-07-010886.txt : 20070509 0000950134-07-010886.hdr.sgml : 20070509 20070509162107 ACCESSION NUMBER: 0000950134-07-010886 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070509 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070509 DATE AS OF CHANGE: 20070509 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ONYX PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001012140 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 943154463 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-28298 FILM NUMBER: 07832769 BUSINESS ADDRESS: STREET 1: 2100 POWELL STREET CITY: EMERYVILLE STATE: CA ZIP: 94608 BUSINESS PHONE: 5105976500 MAIL ADDRESS: STREET 1: 2100 POWELL STREET CITY: EMERYVILLE STATE: CA ZIP: 94608 8-K 1 f30145e8vk.htm FORM 8-K e8vk
 

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 9, 2007
ONYX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
         
DELAWARE   0-28298   94-3154463
         
(State of incorporation)   (Commission File No.)   (IRS Employer Identification No.)
2100 Powell Street
Emeryville, California 94608
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (510) 597-6500
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

ITEM 2.02   RESULTS OF OPERATIONS AND FINANCIAL CONDITION
On May 9, 2007, Onyx Pharmaceuticals, Inc. issued a press release announcing financial results for the three months ending March 31, 2007. A copy of the earnings press release is furnished as Exhibit 99.1 to this report.
This information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in Exhibit 99.1 shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Onyx Pharmaceuticals, Inc., whether made before or after the date here of, regardless of any general incorporation language in such filing.
ITEM 9.01   FINANCIAL STATEMENTS AND EXHIBITS
(d)      Exhibits
     
Exhibit Number   Description
 
   
99.1
  Press Release titled “Onyx Pharmaceuticals Reports First Quarter 2007 Financial Results,” dated May 9, 2007

 


 

Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: May 9, 2007
         
  ONYX PHARMACEUTICALS, INC.
 
 
  By:   /s/ Gregory W. Schafer    
    Gregory W. Schafer   
    Vice President and Chief Financial Officer   

 


 

         
EXHIBIT INDEX
     
Number   Description
 
   
99.1
  Press Release titled “Onyx Pharmaceuticals Reports First Quarter 2007 Financial Results,” dated May 9, 2007

 

EX-99.1 2 f30145exv99w1.htm EXHIBIT 99.1 exv99w1
 

EXHIBIT 99.1
     
Contacts:
   
Julie Wood
  Greg W. Schafer
Vice President, Investor Relations
  Chief Financial Officer
510-597-6505
  510-597-6684
ONYX PHARMACEUTICALS REPORTS FIRST QUARTER 2007 FINANCIAL RESULTS
 
 
EMERYVILLE, CALIF. — May 9, 2007 — Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today reported its financial results for the first quarter ended March 31, 2007. Onyx, with its collaborator, Bayer Pharmaceuticals Corporation, or Bayer, is marketing and developing Nexavar® (sorafenib) tablets, an anticancer drug currently approved for the treatment of advanced kidney cancer in the U.S., European Union, and other territories internationally. Nexavar net revenue, as recorded by Bayer, was $60.9 million for the quarter ended March 31, 2007 compared to $23.7 million in the same period last year.
“We are pleased with the growing number of kidney cancer patients benefiting from Nexavar,” said Hollings C. Renton, President and CEO of Onyx. “In liver cancer, we look forward to the presentation of our pivotal Phase 3 SHARP data at ASCO next month, which showed that Nexavar significantly extends survival in this devastating disease versus placebo. Based on these data, Bayer is preparing regulatory filings for a supplemental indication that we believe could lead to substantial commercial upside in 2008 and beyond.”
Renton continued, “As a monotherapy, Nexavar has proven efficacy in kidney cancer and now has demonstrated superior overall survival in liver cancer, a second tough-to-treat tumor. Nexavar’s favorable product profile, including its activity in combination with chemotherapy, strengthens our belief that Nexavar may also be a successful treatment for additional types of cancers.”
Onyx reported a net loss of $12.2 million, or $0.26 per share, for the first quarter of 2007 compared to a net loss of $20.4 million, or $0.49 per share, in the same period in the prior year. The net loss for the quarter ended March 31, 2007, includes employee stock-based compensation expense of $3.0 million, or $0.06 per share. The net loss for the quarter ended March 31, 2006, included employee stock-based compensation expense of $3.6 million, or $0.09 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 each company for its 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 summary financial information. In the first quarter of 2007, Onyx reported a net amount due from Bayer of $3.0 million compared to a net amount due to Bayer of $4.1 million for the first quarter of 2006. This change is primarily due to an increase in Nexavar revenue recognized by Bayer which is partially offset by increases in the combined commercial and development expenses for Nexavar.
Operating Expenses
In the first quarter of 2007, research and development expenses, including stock-based compensation expense of $0.5 million, was $5.5 million, a decrease of $2.3 million as compared to the first quarter of 2006. This decrease is due to a reduction in activities in the melanoma program subsequent to the release of results in the Phase 2 and Phase 3 metastatic melanoma trials in December 2006.
In the first quarter of 2007, selling, general and administrative expenses, including stock-based compensation expense of $2.5 million, were $13.2 million, an increase of $1.6 million over the first quarter of 2006. This increase is due to an increase in employees in commercial and administrative functions to support our planned growth.

 


 

Cash, Cash Equivalents and Marketable Securities
As of March 31, 2007, the company had cash, cash equivalents, short and long-term marketable securities of $261.8 million compared to $271.4 million at December 31, 2006.
Conference Call with Management Today
Onyx’s management will host a teleconference and web cast to discuss first quarter 2007 financial results and provide a general business overview. The event will begin at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) on May 9, 2007. Interested parties may access a live web cast of the presentation at:
http://events.streamlogics.net/conferenceplus/onyx/may09-07/index.asp
or by dialing 847-413-3235 and using the passcode 17605023. A replay of the presentation will be available on the Onyx website or by dialing 630-652-3044 and using the passcode 17605023 approximately one hour after the teleconference concludes. The replay will be available through June 9, 2007.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative therapies that target the molecular mechanisms that cause cancer. The company is developing Nexavar®, a small molecule drug, with Bayer Pharmaceuticals Corporation. Nexavar has been approved for the treatment of advanced kidney cancer. For more information about Onyx’s pipeline and activities, visit the company’s website at: www.onyx-pharm.com.
Nexavar® (sorafenib) tablets is a registered trademark of Bayer Pharmaceuticals Corporation.
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 the timing, progress and results of the clinical development, regulatory processes, potential clinical trial initiations, potential NDA filings, commercialization efforts and competitors of Nexavar. 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 March 31,  
    2007     2006  
Operating expenses:
               
Net expense due (from) to unconsolidated joint business
  $ (3,025 )   $ 4,102  
Research and development (1)
    5,534       7,800  
Selling, general and administrative (1)
    13,183       11,623  
 
           
Total operating expenses
    15,692       23,525  
 
           
Loss from operations
    (15,692 )     (23,525 )
Interest income
    3,497       3,173  
 
           
Net loss
  $ (12,195 )   $ (20,352 )
 
           
Basic and diluted net loss per share
  $ (0.26 )   $ (0.49 )
 
           
Shares used in computing basic and diluted net loss per share
    46,278       41,292  
 
           
CONDENSED BALANCE SHEETS
(In thousands)
                 
    Mar. 31,     Dec. 31,  
    2007     2006  
    (unaudited)     (2)  
Assets
               
Cash, cash equivalents and marketable securities
  $ 261,751     $ 266,958  
Other current assets
    12,933       12,940  
 
           
Total current assets
    274,684       279,898  
Property and equipment, net
    1,873       1,478  
Other assets
    506       4,870  
 
           
Total assets
  $ 277,063     $ 286,246  
 
           
Liabilities and stockholders’ equity
               
Current liabilities
    17,933       23,466  
Advance from collaboration partner
    40,000       40,000  
Stockholders’ equity
    219,130       222,780  
 
           
Total liabilities and stockholders’ equity
  $ 277,063     $ 286,246  
 
           

 

(1)   Includes employee stock-based compensation expense of $0.5 million and $2.5 million, and $0.7 million and $2.9 million in research and development expense and selling, general and administrative expenses, respectively, in the condensed, unaudited statement of operations for the three months ended March 31, 2007 and 2006, respectively.
 
(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.

 


 

ONYX PHARMACEUTICALS, INC.
CALCULATION OF NET EXPENSE DUE TO (FROM) UNCONSOLIDATED JOINT BUSINESS

(In thousands)
(unaudited)
                 
    Three Months Ended March 31,  
    2007     2006  
 
               
Product revenue, net (as recorded by Bayer)
  $ 60,881     $ 23,747  
Combined cost of goods sold, distribution, selling, general
and administrative expenses
    36,450       17,708  
Combined research and development expenses
    33,290       30,031  
 
           
Combined collaboration loss
  $ 8,859     $ 23,992  
 
           
 
               
Onyx’s share of collaboration loss
  $ 4,430     $ 11,996  
 
               
Reimbursement of Onyx’s direct development and marketing expenses
    (7,455 )     (7,894 )
 
           
 
               
Onyx net expense due (from) to unconsolidated joint business
  $ (3,025 )   $ 4,102  
 
           

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