-----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, WKXSH2RiDDJ93fb20AMn26hV0mf3jml5KkY3O6MCP3pPE+6yMvDa0NUnbFaTyzF/ DjKor9tov+NU+HEblpDHdg== 0001193125-07-161755.txt : 20070725 0001193125-07-161755.hdr.sgml : 20070725 20070725163133 ACCESSION NUMBER: 0001193125-07-161755 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070725 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070725 DATE AS OF CHANGE: 20070725 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: 07999653 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): July 25, 2007

 


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 July 25, 2007, Seattle Genetics, Inc. issued a press release announcing financial results for its second quarter ended June 30, 2007. 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 July 25, 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.

 

    SEATTLE GENETICS, INC.
Date: July 25, 2007   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 July 25, 2007
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

Seattle Genetics Reports Second Quarter 2007 Financial Results and

Highlights Pipeline Progress

— Company in Strong Financial Position to Continue Advancing Its Diverse Pipeline of Antibody-Based Product Candidates for Unmet Needs in Cancer —

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

Bothell, WA—July 25, 2007—Seattle Genetics, Inc. (Nasdaq: SGEN) today reported financial results for the second quarter and six months ended June 30, 2007. In addition, the company provided an update on its broad pipeline of antibody-based therapies for the treatment of unmet needs in cancer.

“Our strong financial position and collaboration with Genentech on SGN-40 enable us to aggressively invest in developing our diverse pipeline of therapeutic antibodies for cancer,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are advancing four product candidates in multiple ongoing clinical trials, and along with our collaborators plan to initiate eight additional clinical trials across our portfolio over the next nine months, focused particularly on SGN-40, SGN-33 and SGN-35. We also intend to file an IND for a fifth antibody product, SGN-70, in the first half of 2008. We look forward to sharing our progress, notably on our SGN-33 and SGN-35 programs, through planned data presentations at the American Society of Hematology (ASH) annual meeting in December 2007.”

About the Pipeline

 

 

SGN-40 is being developed in collaboration with Genentech. During 2007, the companies plan to advance SGN-40 in multiple single agent and combination clinical trials for the treatment of non-Hodgkin’s lymphoma and multiple myeloma.

 

 

SGN-33 is in a phase I dose-escalation clinical trial for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Additional trials, including a phase I clinical trial in combination with Revlimid® for MDS and a phase II trial in combination with low-dose cytarabine for AML, are expected to begin in 2007.

 

 

SGN-35, an antibody-drug conjugate (ADC), is in a phase I dose-escalation clinical trial for Hodgkin’s disease and other CD30-positive hematologic malignancies.

 

 

SGN-30 is in several phase II clinical trials sponsored by the National Cancer Institute in combination with chemotherapy as a treatment for Hodgkin’s disease and anaplastic large cell lymphoma.

 

 

SGN-70 is in preclinical development for a 2008 clinical trial in hematologic malignancies.


Second Quarter Financial Results

Revenues in the second quarter of 2007 increased to $5.6 million, from $2.8 million in the second quarter of 2006. For the first six months of 2007, revenues were $9.9 million, compared to $5.0 million for the same period in 2006. Revenues nearly doubled in both periods of 2007 compared to 2006 primarily due to amounts earned under the company’s SGN-40 collaboration with Genentech established in January 2007. In addition, 2007 revenues include preclinical milestones achieved under the company’s ADC collaborations with Genentech and Progenics.

Total operating expenses for the second quarter of 2007 were $18.0 million, compared to $12.4 million for the second quarter of 2006. For the first six months of 2007, total operating expenses were $32.6 million, compared to $24.0 million in the first six months of 2006. The planned increases in 2007 expenses were primarily driven by SGN-33 manufacturing activities and clinical trial expenses for SGN-40, SGN-33 and SGN-35. Expenses in 2007 also reflect higher employee costs, principally from growth in the company’s clinical and development staff to support expansion and acceleration of clinical trial activities.

Net loss for the second quarter of 2007 was $10.6 million, or $0.18 per share, compared to $8.6 million, or $0.17 per share, for the same period in 2006. For the six months ended June 30, 2007, net loss was $19.4 million, or $0.35 per share, compared to $17.3 million, or $0.37 per share, for the same period in 2006.

As of June 30, 2007, Seattle Genetics had $132.2 million in cash and investments, compared to $140.3 million as of March 31, 2007. The company projects that it will end 2007 with more than $120 million in cash and investments.

Recent accomplishments include:

 

 

Achieving two preclinical milestones under the ADC collaboration agreement with Genentech, triggering undisclosed payments to Seattle Genetics. The milestones are based on Genentech’s continued progress in preclinical development with ADCs utilizing Seattle Genetics’ technology.

 

 

Exercising the company’s right to convert all of its outstanding preferred stock into common stock in early July. This conversion simplifies the company’s capital structure and was enabled by the company’s stock price performance. After the conversion, Seattle Genetics has approximately 66 million shares of common stock outstanding.

 

 

Receiving orphan drug designation from the FDA for SGN-33 in MDS.

 

 

Adding industry veterans John P. McLaughlin and Daniel G. Welch to its Board of Directors, together bringing over 50 years of commercial and operational leadership to the company, and promoting Eric L. Dobmeier to the position of Chief Business Officer.


 

Reporting preclinical data in 15 presentations at the American Association for Cancer Research annual meeting, highlighting progress with the company’s product pipeline and proprietary ADC technology.

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 the Seattle Genetics website at www.seattlegenetics.com, under the News and Investor Information section, or by calling (800) 366-7640 (domestic) or (303) 262-2211. 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, using passcode 11093230. The telephone replay will be available until 5:00 p.m. PT on July 27, 2007.

About Seattle Genetics

Seattle Genetics is a biotechnology company developing monoclonal antibody-based therapies for the treatment of multiple types of cancer, including lymphoma, multiple myeloma, leukemia and solid tumors. The company has an exclusive worldwide collaboration agreement with Genentech to develop and commercialize SGN-40. Seattle Genetics also has three other proprietary programs in ongoing clinical trials: SGN-33, SGN-35 and SGN-30. In addition, the company has developed proprietary antibody-drug conjugate (ADC) technology comprised of 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 and MedImmune, as well as an ADC co-development agreement with Agensys. 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, 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 and the risks inherent in early stage development of drug products. 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, Corporate Communications

(425) 527-4160

ppinkston@seagen.com


Seattle Genetics, Inc.

Condensed Balance Sheets

(Unaudited)

(In thousands)

 

    

June 30,

2007

  

December 31,

2006

Assets

     

Current assets

     

Cash, cash equivalents and short-term investments

   $ 93,501    $ 82,587

Other current assets

     8,083      2,842
             

Total current assets

     101,584      85,429

Property and equipment, net

     7,984      7,794

Long-term investments

     38,713      3,986

Other non-current assets

     486      486
             

Total assets

   $ 148,767    $ 97,695
             

Liabilities and Stockholders’ Equity

     

Accounts payable and accrued liabilities

   $ 6,658    $ 5,389

Deferred revenue

     14,174      3,160
             

Total current liabilities

     20,832      8,549
             

Deferred rent, net of current portion

     437      513

Deferred revenue, net of current portion

     53,039      399
             

Total long-term liabilities

     53,476      912
             

Stockholders’ equity

     74,459      88,234
             

Total liabilities and stockholders’ equity

   $ 148,767    $ 97,695
             


Seattle Genetics, Inc.

Condensed Statements of Operations

(Unaudited)

(In thousands except per share amounts)

 

     Three months ended
June 30
    Six months ended
June 30,
 
     2007     2006     2007     2006  

Revenues

   $ 5,611     $ 2,840     $ 9,947     $ 4,981  

Expenses

        

Research and development

     15,179       10,007       26,984       19,258  

General and administrative

     2,814       2,402       5,634       4,709  
                                

Total operating expenses

     17,993       12,409       32,618       23,967  
                                

Loss from operations

     (12,382 )     (9,569 )     (22,671 )     (18,986 )

Investment income, net

     1,832       926       3,293       1,640  
                                

Net loss

   $ (10,550 )   $ (8,643 )   $ (19,378 )   $ (17,346 )
                                

Basic and diluted net loss per share

   $ (0.18 )   $ (0.17 )   $ (0.35 )   $ (0.37 )
                                

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

     57,064       50,077       55,808       46,269  
                                
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