-----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, O+D26hLqAGyeLdHsBKx7HbdFzILQcbpKGyZ9wjHnYNQz54pORFoPamlMAVjSiLG+ eLwBP9oex8vjRy9/XMNyQg== 0001193125-08-215241.txt : 20081023 0001193125-08-215241.hdr.sgml : 20081023 20081023163034 ACCESSION NUMBER: 0001193125-08-215241 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20081023 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081023 DATE AS OF CHANGE: 20081023 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: 000-32405 FILM NUMBER: 081137594 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): October 23, 2008

 

 

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)

 

 

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):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ 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 October 23, 2008, Seattle Genetics, Inc. issued a press release announcing financial results for its third quarter ended September 30, 2008. A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated into this Form 8-K by reference.

The information included under Item 2.02 of this report is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

99.1    Press Release of Seattle Genetics, Inc. dated October 23, 2008


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.

 

    SEATTLE GENETICS, INC.
Date: October 23, 2008     By:   /s/ Clay B. Siegall
       

Clay B. Siegall

President and Chief Executive Officer


INDEX TO EXHIBITS

 

Exhibit No.

  

Description

99.1    Press Release of Seattle Genetics, Inc. dated October 23, 2008
EX-99.1 2 dex991.htm PRESS RELEASE OF SEATTLE GENETICS, INC. DATED OCTOBER 23, 2008 Press Release of Seattle Genetics, Inc. dated October 23, 2008

Exhibit 99.1

Seattle Genetics Reports Development Progress and

Third Quarter 2008 Financial Results

— Company advancing broad pipeline of cancer therapies and planning

for pivotal trials of SGN-35 in 2009 —

— Conference call today at 5:00 p.m. ET —

Bothell, WA — October 23, 2008 — Seattle Genetics, Inc. (Nasdaq: SGEN) today reported financial results for the third quarter and nine months ended September 30, 2008.

“We are making strong progress across our product portfolio, including advancing twelve clinical trials of four product candidates and finalizing our SGN-35 registration strategy to position the program for pivotal trials to begin in the first half of 2009,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are planning several presentations at the ASH annual meeting in December highlighting data from our dacetuzumab (SGN-40) and SGN-35 programs. In addition, two of our ADC collaborators, Progenics and Genentech, recently initiated clinical trials with their own ADC programs, bringing the total number of clinical-stage ADCs that utilize our technology to four.”

Pipeline and ADC Collaborator Highlights

Dacetuzumab (SGN-40)

 

   

Under a worldwide collaboration with Genentech, the companies are conducting six phase Ib-IIb clinical trials to evaluate dacetuzumab in non-Hodgkin lymphoma and multiple myeloma

 

   

Phase II single-agent data in diffuse large B-cell lymphoma, as well as preclinical research findings, are planned for presentation at the American Society of Hematology (ASH) annual meeting in December 2008

Lintuzumab (SGN-33)

 

   

Three clinical trials are underway, including a phase IIb randomized trial evaluating overall survival of acute myeloid leukemia patients receiving low-dose cytarabine plus or minus lintuzumab

 

   

The company expects to complete enrollment and report data from the phase Ib single-agent trial of lintuzumab in the first half of 2009

 

   

Data from the phase IIb trial are expected in the first half of 2010

SGN-35

 

   

Accrual is completed and data are planned at ASH from the every three week dosing phase I clinical trial in Hodgkin lymphoma and other CD30-positive malignancies

 

   

Data from the weekly dosing phase I clinical trial are planned in 2009

 

   

The company has submitted two special protocol assessments (SPAs) for parallel pivotal clinical trials in patients with relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma

 

   

Seattle Genetics expects to finalize its U.S. registration pathway during 2008 and initiate pivotal trials in the first half of 2009

SGN-70

 

   

During the third quarter, Seattle Genetics initiated a phase I clinical trial in healthy volunteers as part of a development plan for SGN-70 in autoimmune diseases

ADC Collaborations

 

   

Progenics initiated a phase I clinical trial of its PSMA ADC program, triggering a milestone payment to Seattle Genetics

 

   

Genentech initiated a phase I clinical trial of an ADC for cancer utilizing Seattle Genetics’ technology


   

Seattle Genetics achieved a preclinical milestone under its ADC collaboration with Genentech, triggering an undisclosed payment to Seattle Genetics

Third Quarter and Nine Month Financial Results

Revenues in the third quarter of 2008 were $8.1 million, up from $4.6 million in the third quarter of 2007. For the first nine months of 2008, revenues were $25.2 million, compared to $14.6 million for the same period in 2007. Revenues increased in 2008 primarily as a result of the earned portion of reimbursements, upfront and milestone payments received under the company’s dacetuzumab collaboration with Genentech. In addition, 2008 revenues include the earned portion of milestone and other payments received under the company’s ADC collaborations.

Total operating expenses for the third quarter of 2008 were $31.4 million, compared to $21.0 million for the third quarter of 2007. For the first nine months of 2008, total operating expenses were $85.1 million, compared to $53.7 million in the first nine months of 2007. The planned increases in 2008 were primarily driven by clinical development activities and manufacturing campaigns for dacetuzumab, lintuzumab and SGN-35 and higher employee costs, principally related to growth in the company’s clinical and development staff. Dacetuzumab development costs incurred by Seattle Genetics are included in research and development expense, but are fully reimbursed by Genentech under the collaboration. Non-cash, share-based compensation expense for the first nine months of 2008 was $7.4 million, compared to $5.4 million for the same period in 2007.

Net loss for the third quarter of 2008 was $21.8 million, or $0.27 per share, compared to $14.6 million, or $0.22 per share, for the third quarter of 2007. For the nine months ended September 30, 2008, net loss was $54.9 million, or $0.70 per share, compared to $34.0 million, or $0.57 per share, for the same period in 2007.

As of September 30, 2008, Seattle Genetics had $187.1 million in cash and investments, compared to $197.9 million as of June 30, 2008. Based on higher than expected cash received during the year from ADC collaborators and proceeds from stock option exercises, the company now expects that its cash used in operating activities will be at or below the low end of its $75 million to $85 million guidance range, and that it will end 2008 with approximately $150 million in cash and investments.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to discuss the financial results and provide an update on business activities. The event will be held today at 2:00 p.m. Pacific Time (PT); 5:00 p.m. Eastern Time (ET). The live event will be available from Seattle Genetics’ website at www.seattlegenetics.com, under the News and Investor Information section, or by calling (800) 257-3401 (domestic) or (303) 242-0001 (international). A replay of the discussion will be available beginning at approximately 5:00 p.m. PT today from Seattle Genetics’ website or by calling (800) 405-2236 (domestic) or (303) 590-3000 (international), using passcode 11120729. The telephone replay will be available until 5:00 p.m. PT on October 28, 2008.

About Seattle Genetics

Seattle Genetics is a clinical stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The company has four product candidates in ongoing clinical trials: dacetuzumab (SGN-40), lintuzumab (SGN-33), SGN-35 and SGN-70. Dacetuzumab is being developed under a worldwide


collaboration with Genentech. In addition, the company has developed proprietary antibody-drug conjugate (ADC) technology comprising highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen, Progenics, Daiichi Sankyo and MedImmune, a subsidiary of AstraZeneca, as well as an ADC co-development agreement with Agensys, a subsidiary of Astellas Pharma. More information 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 the company’s expectations for initiation of future clinical trials, including the planned pivotal trials of SGN-35, generation of clinical data and future pipeline growth. 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, failure to achieve milestones under our collaborations and unforeseen increased expenses or unexpected reductions in revenues. In addition, we may be delayed in the initiation of our planned pivotal trials of SGN-35 due to regulatory delays or other circumstances beyond the control of the Company. 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.

CONTACT:

Peggy Pinkston

(425) 527-4160

ppinkston@seagen.com


Seattle Genetics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands)

 

     September 30,
2008
   December 31,
2007

Assets

     

Current assets

     

Cash, cash equivalents and short-term investments

   $ 104,526    $ 111,361

Other current assets

     15,417      7,990
             

Total current assets

     119,943      119,351

Property and equipment, net

     11,013      10,294

Long-term investments

     82,568      18,223

Other non-current assets

     476      662
             

Total assets

   $ 214,000    $ 148,530
             

Liabilities and Stockholders’ Equity

     

Accounts payable and accrued liabilities

   $ 14,917    $ 10,475

Deferred revenue

     23,126      18,873
             

Total current liabilities

     38,043      29,348
             

Deferred revenue, net of current portion

     68,771      64,786

Deferred rent and other long-term liabilities

     1,378      410
             

Total long-term liabilities

     70,149      65,196
             

Stockholders’ equity

     105,808      53,986
             

Total liabilities and stockholders’ equity

   $ 214,000    $ 148,530
             

Summary Balance Sheet Information:

     

Cash, cash equivalents and investment securities

   $ 187,094    $ 129,584

Working Capital

   $ 81,900    $ 90,003

 


Seattle Genetics, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except per share amounts)

 

     Three months ended
September 30,
    Nine months ended
September 30,
 
     2008     2007     2008     2007  

Revenues

   $ 8,079     $ 4,637     $ 25,168     $ 14,584  

Operating expenses

        

Research and development

     27,711       17,735       73,362       44,719  

General and administrative

     3,687       3,297       11,716       8,931  
                                

Total operating expenses

     31,398       21,032       85,078       53,650  
                                

Loss from operations

     (23,319 )     (16,395 )     (59,910 )     (39,066 )

Investment income, net

     1,555       1,782       5,006       5,075  
                                

Net loss

   $ (21,764 )   $ (14,613 )   $ (54,904 )   $ (33,991 )
                                

Basic and diluted net loss per share

   $ (0.27 )   $ (0.22 )   $ (0.70 )   $ (0.57 )
                                

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

     79,559       65,957       78,369       59,228  
                                
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