-----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, Js4xmVvd4DmdQLQ9KHIs8eut/Jprrc1e7JzPpoNSJ/07rWO/xi1os4ZXBzC8H9Jh jZVw8WjPQCmTggG5IcYqVw== 0001193125-10-242662.txt : 20101101 0001193125-10-242662.hdr.sgml : 20101101 20101101163115 ACCESSION NUMBER: 0001193125-10-242662 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20101101 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101101 DATE AS OF CHANGE: 20101101 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: 101155280 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): November 1, 2010

 

 

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 November 1, 2010, Seattle Genetics, Inc. issued a press release announcing financial results for its third quarter ended September 30, 2010. 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 November 1, 2010


 

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: November 1, 2010     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 November 1, 2010
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

 

Exhibit 99.1

Seattle Genetics Reports Third Quarter 2010 Financial Results

-Positive top-line data reported from pivotal Hodgkin lymphoma and phase II ALCL brentuximab

vedotin trials position company for first half 2011 BLA submission-

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

Bothell, WA — November 1, 2010 — Seattle Genetics, Inc. (Nasdaq: SGEN) today reported financial results for the third quarter and nine months ended September 30, 2010. The company also highlighted recent product development activities and upcoming milestones.

“The remarkable data we recently reported from two clinical trials with our lead program, brentuximab vedotin, support our strategy to advance the program towards a planned Biologics License Application (BLA) submission in the first half of 2011,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “These trials also illustrate the broader potential opportunity for brentuximab vedotin in CD30-positive hematologic malignancies, which we are pursuing through our ongoing and planned clinical development activities. During the third quarter, we also made significant progress with our pipeline of proprietary antibody-drug conjugates (ADCs), including SGN-75 and ASG-5ME, and received multiple upfront and milestone payments under our ADC collaborations. There are now nine ADCs using our technology in clinical development.”

Recent Highlights and Upcoming Milestones

Brentuximab Vedotin (SGN-35)

 

   

Reported that 75 percent of relapsed or refractory Hodgkin lymphoma patients in a pivotal clinical trial achieved an objective response; median duration of response was greater than six months

 

   

Reported that 86 percent of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) patients in a phase II clinical trial achieved an objective response; the median duration of response has not yet been reached at a median follow up on study of approximately six months

 

   

Reported that the safety profile in the pivotal Hodgkin lymphoma and phase II ALCL trials was generally consistent with prior clinical trial experience

 

   

Plan to present more complete data from the pivotal Hodgkin lymphoma and phase II ALCL trials in two oral sessions at the American Society of Hematology (ASH) Annual Meeting in December 2010

 

   

Expect to discuss regulatory next steps with the U.S. Food and Drug Administration (FDA) later in 2010 with the goal of including both Hodgkin lymphoma and ALCL indications in a BLA submission planned for the first half of 2011

 

   

Featured brentuximab vedotin at the 8th International Symposium on Hodgkin Lymphoma describing ongoing clinical trials, including a phase II retreatment trial and the phase III AETHERA trial, and presented preclinical data on the combination of brentuximab vedotin with other anticancer agents

 

   

Continued life cycle management planning with Millennium: The Takeda Oncology Company, including clinical trials to expand the potential for brentuximab vedotin in both earlier lines of lymphoma therapy and other CD30-positive malignancies

SGN-75

 

   

Reported interim results at the European Society for Medical Oncology Congress from a dose-escalation phase I clinical trial in patients with relapsed or refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma demonstrating tolerability and antitumor activity, including two objective responses in the first 16 patients treated; dose-escalation is continuing


 

ASG-5ME (co-development program with Agensys, an affiliate of Astellas Pharma)

 

   

Announced initiation of a phase I clinical trial for the treatment of castration-resistant prostate cancer

 

   

Continued dose escalation in a phase I clinical trial for patients with metastatic pancreatic cancer

SGN-70

 

   

Data from a phase I trial in healthy volunteers and patients with mild to moderate plaque psoriasis will be presented in a poster session at the American College of Rheumatology Annual Scientific Meeting in November 2010

Lintuzumab (SGN-33)

 

   

Discontinued development based on data from a phase IIb clinical trial in older patients with acute myeloid leukemia demonstrating that the study did not meet its primary endpoint of extending overall survival

ADC Collaborations

 

   

Entered into an ADC research collaboration with Genmab A/S under which Seattle Genetics’ ADC technology will be utilized with Genmab’s HuMax-TF antibody targeting the Tissue Factor antigen, which is expressed on numerous types of solid tumors; Seattle Genetics received an upfront payment and has the right to exercise a co-development option for any resulting ADC products based on phase I clinical data

 

   

Achieved a milestone under an ADC collaboration with Agensys, an affiliate of Astellas Pharma, triggered by Agensys’ initiation of a phase I trial for AGS-16M8F, an ADC for the treatment of cancer utilizing Seattle Genetics’ technology

 

   

Received an upfront payment of $12 million through expansion of an ADC collaboration with Genentech, a member of the Roche Group; under the initial and expanded collaboration, Seattle Genetics is eligible to receive greater than $1.4 billion in fees and milestones if all ADCs are commercialized under this collaboration, as well as mid-single digit royalties on worldwide net sales of any resulting ADC products

 

   

Achieved milestones under ADC collaboration with Genentech, including a milestone triggered by Genentech’s submission of an Investigational New Drug (IND) application to the FDA for an ADC utilizing Seattle Genetics’ technology for the treatment of cancer

 

   

Achieved a preclinical milestone under ADC collaboration with Millennium

Third Quarter 2010 Financial Results

Revenues in the third quarter of 2010 were $16.0 million, up from $11.6 million in the third quarter of 2009. The increase was driven by amounts earned under the company’s ADC collaborations. For the first nine months of 2010, revenues were $99.3 million, up from $30.2 million in the first nine months of 2009. The increase in year-to-date 2010 revenues was driven primarily by the earned portion of payments received under the company’s dacetuzumab (SGN-40) collaboration with Genentech, which ended in June 2010.

Total operating expenses for the third quarter of 2010 were $51.3 million, compared to $32.2 million for the third quarter of 2009. For the first nine months of 2010, total operating expenses were $132.6 million, compared to $102.4 million in the first nine months of 2009. The planned increases in 2010 were primarily driven by clinical development and manufacturing activities for brentuximab vedotin,


technology access fees and lintuzumab manufacturing costs, partially offset by lower spending on dacetuzumab and lintuzumab clinical trials. Under the collaboration with Millennium, brentuximab vedotin development costs incurred by Seattle Genetics are included in research and development expense. Joint development costs are co-funded by Millennium on a 50:50 basis. Reimbursement payments are recognized as revenue over the development period of the collaboration along with other payments received. Non-cash, share-based compensation expense for the first nine months of 2010 was $10.1 million, compared to $8.5 million for the same period in 2009.

Net loss for the third quarter of 2010 was $34.9 million, or $0.34 per share, compared to a net loss of $19.8 million, or $0.21 per share, for the third quarter of 2009. For the nine months ended September 30, 2010, net loss was $31.7 million, or $0.31 per share, compared to a net loss of $69.6 million, or $0.79 per share, for the same period in 2009.

As of September 30, 2010, Seattle Genetics had $315.6 million in cash and investments, compared to $287.7 million as of December 31, 2009. The year-to-date increase includes a $60 million upfront payment received in the first quarter of 2010 under the company’s brentuximab vedotin collaboration with Millennium, and approximately $40 million in upfront payments, milestones and renewal fees received under the company’s ADC collaborations.

As a result of expanded ADC licensing activities, Seattle Genetics is updating its financial guidance for 2010. Revenues are expected to exceed the top end of previous guidance of $105 million for 2010 and the company expects to end 2010 with more than $280 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 Investors and News section, or by calling (877) 941-8632 (domestic) or (480) 629-9820 (international). The access code is 4373835. A replay of the discussion will be available beginning at approximately 4:00 p.m. PT today from Seattle Genetics’ website or by calling (800) 406-7325 (domestic) or (303) 590-3030 (international), using access code 4373835. The telephone replay will be available until 4:00 p.m. PT on Wednesday, November 3, 2010.

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 recently reported positive top-line data from both a pivotal Hodgkin lymphoma trial and phase II anaplastic large cell lymphoma trial with its lead product candidate, brentuximab vedotin, and plans to submit a BLA to the FDA in the first half of 2011. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has four other clinical-stage programs: SGN-75, ASG-5ME, dacetuzumab (SGN-40) and SGN-70. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium: The Takeda Oncology Company and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. 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 regulatory approval and commercial launch of brentuximab vedotin, initiation of future clinical trials, data availability from ongoing clinical trials, and the company’s expectations for its 2010 financial outlook. 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 that the company may experience delays in the completion of its clinical trials, whether caused by competition, adverse events, patient enrollment rates, regulatory issues or other factors; that data from our phase I and phase II clinical trials of brentuximab vedotin may not necessarily be indicative of subsequent clinical trial results; and that the safety and/or efficacy results of these trials, including the brentuximab vedotin pivotal clinical trial for relapsed and refractory Hodgkin lymphoma and the phase II trial for relapsed and refractory ALCL, will not support marketing approval for the submitted indications. In addition, we may not obtain priority review of our marketing application and consequently may be delayed in the planned U.S. commercial launch of brentuximab vedotin. We may also fail to achieve milestones under our collaborations and experience unforeseen increased expenses or unexpected reductions in revenues. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company’s 10-Q for the quarter ended June 30, 2010 filed 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,
2010
     December 31,
2009
 

Assets

     

Cash, cash equivalents, short and long term investments

   $ 315,649       $ 287,730   

Other assets

     33,067         100,603   
                 

Total assets

   $ 348,716       $ 388,333   
                 

Liabilities and Stockholders’ Equity

     

Accounts payable and accrued liabilities

   $ 26,980       $ 19,496   

Deferred revenue and long-term liabilities

     131,949         162,637   

Stockholders’ equity

     189,787         206,200   
                 

Total liabilities and stockholders’ equity

   $ 348,716       $ 388,333   
                 


 

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,
 
     2010     2009     2010     2009  

Revenues

   $ 15,991      $ 11,646      $ 99,324      $ 30,196   

Expenses

        

Research and development

     44,287        28,263        113,890        90,221   

General and administrative

     7,038        3,956        18,736        12,131   
                                

Total operating expenses

     51,325        32,219        132,626        102,352   
                                

Loss from operations

     (35,334     (20,573     (33,302     (72,156

Investment income, net

     478        746        1,583        2,590   
                                

Net loss

   $ (34,856   $ (19,827   $ (31,719   $ (69,566
                                

Basic and diluted net loss per share

   $ (0.34   $ (0.21   $ (0.31   $ (0.79
                                

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

     101,221        93,460        100,922        87,771   
                                
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