-----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, Jz2pg8q4C/MUGZmvPAQ7aN+Fo0aeQP50Bj/bF6zHU3UXvrvqYoM27LC7cdmQK8ob t+9b8HPmqyv4M+5ImTKG2Q== 0000950123-09-058395.txt : 20091105 0000950123-09-058395.hdr.sgml : 20091105 20091105161013 ACCESSION NUMBER: 0000950123-09-058395 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20091105 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091105 DATE AS OF CHANGE: 20091105 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Trubion Pharmaceuticals, Inc CENTRAL INDEX KEY: 0001298521 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33054 FILM NUMBER: 091161290 BUSINESS ADDRESS: STREET 1: 2401 4TH AVENUE STREET 2: SUITE 1050 CITY: SEATTLE STATE: WA ZIP: 98121 BUSINESS PHONE: 2068380500 MAIL ADDRESS: STREET 1: 2401 4TH AVENUE STREET 2: SUITE 1050 CITY: SEATTLE STATE: WA ZIP: 98121 8-K 1 v53940e8vk.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
November 5, 2009 (Date of Report)
(Date of Earliest Event Reported)
Trubion Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
         
Delaware
(State or Other Jurisdiction
of Incorporation)
  001-33054
(Commission File No.)
  52-2385898
(IRS Employer
Identification No.)
2401 Fourth Avenue, Suite 1050, Seattle, WA 98121
(Address of Principal Executive Offices, including Zip Code)
(206) 838-0500
(Registrant’s Telephone Number, Including Area Code)
None
(Former Name or Former Address, if Changed Since Last Report)
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:
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 November 5, 2009, Trubion Pharmaceuticals, Inc. announced its financial results for the third quarter ended September 30, 2009. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d)   Exhibits.
  99.1   Press Release of Trubion Pharmaceuticals, Inc., dated November 5, 2009.

 


 

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.
         
  TRUBION PHARMACEUTICALS, INC.
 
 
Date: November 5, 2009  By:   /s/ Michelle G. Burris    
    Michelle G. Burris   
    Senior Vice President and
Chief Financial Officer 
 

 


 

         
INDEX TO EXHIBITS
     
Exhibit No.   Description
99.1
  Press Release of Trubion Pharmaceuticals, Inc., dated November 5, 2009.

 

EX-99.1 2 v53940exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
For Release 1 p.m. PST
Nov. 5, 2009
Trubion Pharmaceuticals, Inc. Reports Third Quarter and Nine Months 2009 Financial
Results
SEATTLE, Nov. 5, 2009 — Trubion Pharmaceuticals, Inc. (NASDAQ: TRBN) today announced financial results for its third quarter and nine months ended Sept. 30, 2009.
Third Quarter and Nine Months 2009 Financial Results
Revenue for the third quarter and nine months ended Sept. 30, 2009, was $4.5 million and $12.8 million, respectively, compared with $3.8 million and $12.2 million, respectively, in 2008. Revenues were primarily earned through Trubion’s strategic collaborations with Pfizer Inc. and Facet Biotech Corporation (announced August 28, 2009).
Of the $12.8 million in revenue Trubion recognized during the first nine months of 2009, $8.5 million was collaborative research funding from the Pfizer collaboration and $3.6 million for recognition of the $40 million upfront fee received from Wyeth prior to its acquisition by Pfizer. Revenue earned in the nine months ended Sept. 30, 2009, also included $643,000 that was earned through the Facet collaboration. This is composed of $191,000 for recognition of the $20 million upfront fee and $1.4 million equity premium, and $452,000 in collaborative research funding.
This is compared with revenue of $12.2 million recognized in the first nine months of 2008, which was composed of $8.1 million for collaboration research funding from the Pfizer collaboration and $4.1 million for recognition of the $40 million upfront fee paid by Wyeth prior to its acquisition by Pfizer.
Total operating expenses for the third quarter and first nine months of 2009 were $10.6 million and $36.5 million, respectively, compared with $10.4 million and $32.3 million in 2008.
Net loss for the third quarter and nine months ended Sept. 30, 2009, was $6.2 million, or $0.33 per diluted common share, and $23.9 million, or $1.31 per diluted common share, respectively. This is compared with a net loss of $6.6 million, or $0.37 per diluted common share, and $19.2 million, or $1.07 per diluted common share, in 2008.
Trubion had $61.7 million in cash, cash equivalents and investments as of Sept. 30, 2009, compared with $52.9 million as of Dec. 31, 2008.
“Over the past nine months, we have continued to advance our clinical programs, including TRU-015 for rheumatoid arthritis, TRU-016 for chronic lymphocytic leukemia and SBI-087 for rheumatoid arthritis and systemic lupus erythematosus,” said Peter Thompson, M.D., FACP, president, chief executive officer and chairman of Trubion. “The data we’ve collected from each study to-date suggests that these product candidates may provide differentiated, best-in-class treatments for patients with autoimmune and inflammatory diseases, or cancer. In addition, our Facet agreement has significantly extended our runway, and we continue to meter our expenses to reduce our previously anticipated cash burn rate.”
Recent milestones
  •   On Aug. 27, 2009, Trubion entered into an agreement with Facet for the worldwide development and commercialization of TRU-016, a CD37-directed product candidate in phase 1 clinical development for the treatment of chronic lymphocytic leukemia (CLL). Trubion received an upfront payment of $20 million and may receive up to $176.5 million in additional contingent payments upon the achievement of certain development, regulatory and sales milestones. In addition, Facet purchased 2,243,649 shares of Trubion common stock for an aggregate purchase of $10 million, or $4.46 per share.

 


 

  •   Trubion presented the second course of re-treatment data from a Phase 2b study (15002) of TRU-015 for rheumatoid arthritis (RA) at the American College of Rheumatology (ACR) Annual Meeting in Oct. 2009. Data continue to demonstrate that repeat administration of TRU-015 is well-tolerated and improves the signs and symptoms of RA as measured by the ACR rates. At 24 weeks after the second re-treatment course, subjects in the group that had received 800 mg of TRU-015 of the initial treatment achieved ACR 20, 50 and 70 response rates of 72%, 39% and 21%, respectively. Results were similar to the response rates seen 24 weeks after the first re-treatment of the same cohort as presented at the European League Against Rheumatism (EULAR) Annual Meeting in June 2009 (70%, 40% and 23%, respectively). Trubion has now administered more than 1,300 doses of TRU-015 over a period of four and a half years.
 
  •   In September 2009, patient enrollment was completed in the second Phase 2b study (2203) of TRU-015 for RA.
2009 Financial Guidance
The company has revised its 2009 guidance after taking into account its collaboration agreement with Facet. As a result, the company has lowered its anticipated annual burn rate from $30 million-$35 million to $0-$5 million. No changes have been made to anticipated revenues for 2009. The revised guidance is as follows:
  •   Reiterate 2009 revenues of approximately $15 million to $20 million; and
 
  •   Revised 2009 operating cash requirements are now expected to be approximately $0 to $5 million.
This guidance does not include any additional cash receipts associated with potential new partnerships.
Conference Call Details
Trubion will host a conference call and webcast to discuss its third quarter and nine months ended Sept. 30, 2009, financial results and provide an update on business activities. The call will be held Nov. 5 at 2 p.m. Pacific Time, 5 p.m. Eastern Time. The live event will be available from Trubion’s website at http://investors.trubion.com, or by calling (703) 639-1156 or (866) 238-0637. A replay of the discussion will be available beginning at 8 p.m. Eastern Time from Trubion’s website or by calling (703) 925-2533 or (888) 266-2081 and entering 1408250. The telephone replay will be available until midnight, Nov. 11, 2009.
About Trubion
Trubion is a biopharmaceutical company that is creating a pipeline of novel protein therapeutic product candidates to treat autoimmune and inflammatory diseases and cancer. The Company’s mission is to develop a variety of first-in-class and best-in-class product candidates, customized for optimal safety, efficacy and convenience that it believes may offer improved patient experiences. Trubion’s current product candidates are novel single-chain protein, or SMIP, therapeutics, and are designed using its custom drug assembly technology. Trubion’s product pipeline includes CD20-directed SMIP therapeutics such as TRU-015 and SBI-087 for autoimmune and inflammatory diseases, developed under the Company’s Pfizer collaboration. Trubion’s product pipeline also includes TRU-016, a novel CD37-targeted therapy for the treatment of B-cell malignancies developed under the company’s Facet collaboration. In addition to Trubion’s current clinical stage product pipeline, the Company is also developing its multi-specific SCORPION technology, both for targeting cell-surface molecules like CD79b and HLA-DR, as well simultaneously neutralizing soluble ligands like TNF and IL-6. More information is available in the investors section of Trubion’s website: http://investors.trubion.com/index.cfm.
Forward-Looking Statements
Certain statements in this release may constitute “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934 and Section 27A of the Securities Act of 1933. These statements include, but are not limited to, those related to the potential development and commercialization of TRU-015. These statements are based on current expectations and

 


 

assumptions regarding future events and business performance and involve certain risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited to, risks associated with the Company’s collaborations, including the risk that the Company and Pfizer with regard to TRU-015 and SBI-087, and the Company and Facet with regard to TRU-016, are unable to advance their respective clinical development programs and regulatory applications and action at the expected rate, the risk that the Company is unable to develop or commercialize its clinical-stage products, the risk that the Company does not achieve the financial results that it expects during 2010 and such other risks as are identified in the Company’s quarterly report on Form 10-Q for the period ended September 30, 2009, and from time to time in other reports filed by Trubion with the U.S. Securities and Exchange Commission. These reports are available on the Investors page of the company’s corporate website at http://www.trubion.com. Trubion undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company’s expectations.
TRBN-G
Contact:
Jim DeNike
Senior Director, Corporate Communications
Trubion Pharmaceuticals, Inc.
(206) 838-0500
jdenike@trubion.com
http://www.trubion.com
Waggener Edstrom Worldwide Healthcare
Amy Petty
Senior Account Executive
(617) 576-5788
amyp@waggeneredstrom.com
(Tables Follow)

 


 

TRUBION PHARMACEUTICALS. INC.
STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(unaudited)
                                 
    Three months ended September 30,     Nine months ended September 30,  
    2009     2008     2009     2008  
 
                               
Revenue
  $ 4,452     $ 3,766     $ 12,783     $ 12,197  
 
                               
Operating expenses:
                               
Research and development
    7,410       7,397       27,587       23,302  
General and administrative
    3,146       2,987       8,877       8,985  
 
                       
Total operating expenses
    10,556       10,384       36,464       32,287  
 
                       
Loss from operations
    (6,104 )     (6,618 )     (23,681 )     (20,090 )
Interest income
    8       370       162       1,585  
Interest expense
    (131 )     (334 )     (409 )     (677 )
 
                       
Net loss
  $ (6,227 )   $ (6,582 )   $ (23,928 )   $ (19,182 )
 
                       
 
                               
Basic and diluted net loss per share
  $ (0.33 )   $ (0.37 )   $ (1.31 )   $ (1.07 )
 
                       
 
                               
Shares used in computation of basic and diluted net loss per share
    18,868       17,859       18,267       17,847  
 
                       
                 
    September 30   December 31,
    2009   2008
 
               
Balance Sheet Data:
               
Cash and cash equivalents
  $ 31,811     $ 29,969  
Investments
    29,920       22,928  
Total assets
    72,676       67,290  
Deferred revenue
    37,054       19,493  
Total stockholders’ equity
    19,017       31,468  

 

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