-----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, FHV5qsqO1sgYeCUHDAXJVFtl4QTH9P7UjBctU4RjBPGTZ+io9AVpOXX8icBx7SUQ 5ha7xaaO2UTDpyrMoCjSNQ== 0001193125-04-070826.txt : 20040427 0001193125-04-070826.hdr.sgml : 20040427 20040427152239 ACCESSION NUMBER: 0001193125-04-070826 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040427 ITEM INFORMATION: ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040427 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SEATTLE GENETICS INC /WA CENTRAL INDEX KEY: 0001060736 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 911874389 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 333-50266 FILM NUMBER: 04756889 BUSINESS ADDRESS: STREET 1: 21823 30TH DRIVE SE STREET 2: SUITE CITY: BOTHELL STATE: WA ZIP: 98021 BUSINESS PHONE: 4255274000 MAIL ADDRESS: STREET 1: 21823 30TH DRIVE SE STREET 2: SUITE CITY: BOTHELL STATE: WA ZIP: 98021 8-K 1 d8k.htm FORM 8-K Form 8-K

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): April 27, 2004

 

Date of Filing: April 27, 2004

 


 

Seattle Genetics, Inc.

(Exact name of Registrant as specified in its charter)

 


 

Delaware   0-32405   91-1874389

(State or other jurisdiction of

incorporation or organization)

  (Commission File Number)  

(I.R.S. Employer

Identification No.)

 

21823 30th Drive SE

Bothell, Washington 98021

(Address of principal executive offices, including zip code)

 

(425) 527-4000

(Registrant’s telephone number, including area code)

 



Item 7. Financial Statements and Exhibits

 

(c) Exhibits

 

99.1   Press Release of Seattle Genetics, Inc. dated April 27, 2004.

 

Item 12. Results of Operations and Financial Conditions

 

On April 27, 2004, Seattle Genetics, Inc. issued a press release announcing financial results for its first quarter ended March 31, 2004. A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated into this Form 8-K by reference.

 

The information in this Form 8-K, including the attached Exhibit, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.


SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

   

SEATTLE GENETICS, INC.

(Registrant)

Date: April 27, 2004

 

By:

 

/s/ Tim Carroll


       

Tim Carroll

       

Chief Financial Officer


INDEX TO EXHIBITS

 

Exhibit No.

 

Description


99.1   Press Release of Seattle Genetics, Inc. dated April 27, 2004.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

Seattle Genetics Reports First Quarter 2004 Results

 

Company ends first quarter with three product candidates in clinical trials and

$131.7 million in cash and investments

 

Bothell, WA — April 27, 2003— Seattle Genetics, Inc. (Nasdaq: SGEN) today reported results for its first quarter ended March 31, 2004.

 

Revenues for the first quarter of 2004 were $2.0 million, compared to $710,000 in the first quarter of 2003. The increase is attributable to fees earned from the company’s ongoing collaborations with Genentech, Protein Design Labs, Celltech and Genencor International.

 

Total operating expenses for the first quarter of 2004 were $9.2 million, compared to $7.0 million for the first quarter of 2003. Research and development expenses increased to $7.6 million in the first quarter of 2004, compared to $5.5 million in the first quarter of 2003. This growth was primarily driven by an increase in manufacturing activities for clinical grade materials and growth of the company’s workforce. General and administrative expenses were $1.5 million in the first quarter of 2004, compared to $1.1 million in the first quarter of 2003. As of March 31, 2004, Seattle Genetics had 113 employees, up 18 percent from 96 as of March 31, 2003.

 

Seattle Genetics recorded a non-cash charge for a preferred stock deemed dividend of $2.2 million for the first quarter of 2004. The non-cash preferred stock deemed dividend is associated with the company’s $41 million private placement of Series A convertible preferred stock that closed in July 2003. Seattle Genetics will record non-cash charges for the preferred stock deemed dividend of $27.1 million and $7.2 million, respectively, in the second and third quarters of 2004.

 

Net loss attributable to common stockholders for the first quarter of 2004 was $8.9 million, or $0.24 per share, compared to $6.0 million, or $0.20 per share, for the same period in 2003.

 

As of March 31, 2004, Seattle Genetics had $131.7 million in cash, cash equivalents, short-term and long-term investments, compared to $73.7 million as of December 31, 2003. The increase is primarily due to Seattle Genetics’ follow-on public offering in February 2004 that resulted in net proceeds to the company of $62.1 million.

 

“We achieved significant milestones during the first quarter, including initiating phase II clinical trials of SGN-30, commencing a phase I clinical trial of SGN-40 and reporting progress with SGN-35, SGN-75 and our industry-leading antibody-drug conjugate technology at the American Association for Cancer Research annual meeting,” commented Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We also completed a follow-on public offering that places us in a strong financial position to continue advancing our pipeline of clinical and preclinical product candidates.”


Recent highlights include:

 

On March 25, 2004, Seattle Genetics announced that it had initiated a phase I clinical trial of SGN-40, a humanized monoclonal antibody that targets the CD40 antigen, for patients with multiple myeloma. The single-agent, open label study of SGN-40 is being conducted at four leading cancer centers in the United States. The company plans to initiate another clinical trial of SGN-40 in patients with refractory non-Hodgkin’s lymphoma in the second half of 2004.

 

On March 24, 2004, Seattle Genetics reported advances in its preclinical research, including its industry-leading antibody-drug conjugate (ADC) technology, during five poster presentations at the 2004 Annual Meeting of the American Association for Cancer Research (AACR) held in March. The data describe the significant advances the company is making toward the optimization of the stability, potency and safety of ADCs such as SGN-35 as well as novel findings on SGN-75, an anti-CD70 ADC in development in renal cancer. In addition, the company presented preclinical data showing synergistic activity of SGN-30 in combination with chemotherapy.

 

On February 26, 2004, Seattle Genetics announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to its product candidate SGN-30 for T-cell lymphomas, a category of non-Hodgkin’s lymphoma that includes anaplastic and cutaneous lymphoma. SGN-30 is a monoclonal antibody currently in phase II clinical trials for the treatment of anaplastic large cell lymphoma and Hodgkin’s disease. The FDA previously granted SGN-30 orphan drug designation for Hodgkin’s disease in July 2003. Seattle Genetics plans to initiate a phase II study of SGN-30 in cutaneous lymphoma later in 2004.

 

On February 24, 2004, Seattle Genetics announced that it had entered into an agreement with Abbott Laboratories for manufacturing of SGN-30. This antibody is also used in Seattle Genetics’ SGN-35 ADC product candidate. Under the terms of the agreement, Abbott will perform scale-up and GMP manufacturing for clinical trials, as well as supply commercial-grade material to support potential regulatory approval and commercial launch.

 

On February 10, 2004, Seattle Genetics announced the completion of its follow-on public offering of 8,050,000 shares of common stock, which includes the over-allotment option exercised by the underwriters of the public offering. Total net proceeds from the offering were approximately $62.1 million.

 

On January 22, 2004, Seattle Genetics announced that it had initiated phase II clinical trials of SGN-30 in patients with Hodgkin’s disease or anaplastic large cell lymphoma. The studies are designed to assess the tolerability and antitumor activity of SGN-30 in patients who have relapsed or are refractory to prior therapies.

 

On January 12, 2004, Seattle Genetics announced that it had expanded its existing ADC collaboration with Protein Design Labs (PDL). Under the amended agreement, Seattle Genetics is providing additional research and development support to PDL for products combining PDL’s therapeutic antibodies and Seattle Genetics’ proprietary ADC technology. In exchange, PDL will pay Seattle Genetics increased fees, milestones and royalties under the modified ADC collaboration. PDL has also granted Seattle Genetics a license and options for two additional licenses under PDL’s antibody humanization patents.


About Seattle Genetics

 

Seattle Genetics discovers and develops monoclonal antibody-based therapeutics to treat cancer and other human diseases. The company has built a diverse portfolio of product candidates targeted to many types of cancer, including three being tested in multiple ongoing clinical trials, SGN-30, SGN-15 and SGN-40, and three in preclinical development, SGN-35, SGN-75 and SGN-17/19. The product candidates encompass three platform technologies: genetically engineered monoclonal antibodies, antibody-drug conjugates (ADCs) and antibody-directed enzyme prodrug therapy (ADEPT). Seattle Genetics has developed leading ADC technology comprised of highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. The company currently has license agreements for its ADC technology with Genentech, Celltech Group and Protein Design Labs and for its ADEPT technology with Genencor International. More information about Seattle Genetics can be found at www.seattlegenetics.com.

 

Certain of the statements made in this press release are forward-looking, such as those, among others, relating to ongoing and planned clinical trials and preclinical development activities. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks related to adverse clinical results as our product candidates move into and advance in clinical trials, risks inherent in early stage development and failure by Seattle Genetics to secure collaborators. More information about the risks and uncertainties faced by Seattle Genetics is contained in the Company’s filings with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

CONTACTS:

Tim Carroll, Chief Financial Officer

(425) 527-4150

tcarroll@seagen.com

 

Peggy Pinkston, Investor Relations

(425) 527-4160

ppinkston@seagen.com


Seattle Genetics, Inc.

Statements of Operations

(Unaudited)

(In thousands except shares and per share amounts)

    

Three months ended

March 31


 
     2004

    2003

 

Revenues

   $ 1,972     $ 710  

Expenses

                

Research and development

     7,572       5,528  

General and administrative

     1,455       1,138  

Noncash stock-based compensation expense

     153       344  
    


 


Total operating expenses

     9,180       7,010  
    


 


Loss from operations

     (7,208 )     (6,300 )

Investment income, net

     543       338  
    


 


Net loss

     (6,665 )     (5,962 )

Noncash preferred stock deemed dividend

     (2,244 )     —    
    


 


Net loss attributable to common stockholders

   $ (8,909 )   $ (5,962 )
    


 


Basic and diluted net loss per share

   $ (0.24 )   $ (0.20 )
    


 


Weighted-average shares used in computing basic and diluted net loss per share

     36,548,127       30,549,829  
    


 



Seattle Genetics, Inc.

Balance Sheets

(Unaudited)

(In thousands)

 

    

March 31,

2004


  

December 31,

2003


Assets

             

Current assets

             

Cash, cash equivalents and short-term investments

   $ 50,650    $ 40,830

Other current assets

     2,869      1,841
    

  

Total current assets

     53,519      42,671

Property and equipment, net

     6,720      5,500

Long-term investments

     81,021      32,852

Restricted investments

     980      976

Other assets

     —        —  
    

  

Total assets

   $ 142,240    $ 81,999
    

  

Liabilities and Stockholders’ Equity

             

Accounts payable and accrued liabilities

   $ 3,679    $ 1,726

Deferred revenue

     4,041      2,106
    

  

Total current liabilities

     7,720      3,832
    

  

Deferred rent

     416      390

Deferred revenue, net of current portion

     3,308      2,899
    

  

Total long-term liabilities

     3,724      3,289
    

  

Stockholders’ equity

     130,796      74,878
    

  

Total liabilities and stockholders’ equity

   $ 142,240    $ 81,999
    

  

-----END PRIVACY-ENHANCED MESSAGE-----