-----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, BWeDfgliZ9tVR4GvZ6j5xfYoDyurjIFNJ5H1oI72MVGk2ziJvfr8ogFjBuWAX2DM KIe/NDohKyAn2PAXUa0YcQ== 0001157523-08-003803.txt : 20080506 0001157523-08-003803.hdr.sgml : 20080506 20080506161323 ACCESSION NUMBER: 0001157523-08-003803 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080506 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080506 DATE AS OF CHANGE: 20080506 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ZYMOGENETICS INC CENTRAL INDEX KEY: 0001129425 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 911144498 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-33489 FILM NUMBER: 08806543 BUSINESS ADDRESS: STREET 1: 1201 EASTLAKE AVENUE E CITY: SEATTLE STATE: WA ZIP: 98102 BUSINESS PHONE: 206-442-6600 MAIL ADDRESS: STREET 1: 1201 EASTLAKE AVENUE E CITY: SEATTLE STATE: WA ZIP: 98102 8-K 1 a5678023.htm ZYMOGENETICS, INC. 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

May 6, 2008
____________________________

Date of Report:
(Date of earliest event reported)

ZYMOGENETICS, INC.


(Exact Name of Registrant as Specified in Charter)

Washington  

000-33489

91-1144498

(State or Other Jurisdiction

of Incorporation)

(Commission File No.)

 

(IRS Employer

Identification No.)

1201 Eastlake Avenue East, Seattle, Washington 98102-3702

(Address of Principal Executive Offices, including Zip Code)

(206) 442-6600


(Registrant’s Telephone Number, Including Area Code)


(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 (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 May 6, 2008, ZymoGenetics, Inc. (the "Company") issued a press release announcing its financial results for the first quarter and year ended March 31, 2008. The full text of the press release is set forth in Exhibit 99.1 attached hereto. The press release should be read in conjunction with the note regarding forward-looking statements, which is included in the text of the press release.

The information in this Current Report on Form 8-K, including the exhibits, will not be treated as "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section. This information will not be incorporated by reference into any filing under the Securities Act of 1933, or into another filing under the Exchange Act, unless that filing expressly incorporates this information by reference.

Item 9.01     Financial Statements and Exhibits.

      (d)    99.1        Press Release dated May 6, 2008


SIGNATURE

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.

ZYMOGENETICS, INC.

 

 

Dated:

May 6, 2008 By:

/s/ James A. Johnson

 

James A. Johnson

 

Executive Vice President and
Chief Financial Officer


Exhibit Index

 99.1     Press Release issued May 6, 2008

EX-99.1 2 a5678023ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

ZymoGenetics Reports First Quarter 2008 Financial Results

January FDA Approval of RECOTHROM and Launch Highlights

SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN), today reported its financial results for the first quarter ended March 31, 2008. The company reported a net loss of $40.9 million, or $0.60 per share, compared to a net loss of $33.3 million, or $0.49 per share, for the first quarter of 2007. The 2008 net loss increased according to the company’s plan, reflecting initial sales and increased sales and marketing efforts associated with the U.S. launch of RECOTHROM™ Thrombin, topical (Recombinant), the company’s first commercial product, which was approved by the FDA in January 2008.

“The approval of RECOTHROM was a major accomplishment. We’re now a commercial company focused on sales growth as well as on driving development of our novel protein therapeutics,” stated Bruce L.A. Carter, Ph.D., chief executive officer of ZymoGenetics. “We believe the launch is going well, and we’re seeing strong interest in the marketplace, reflecting an appreciation for the advantages of a recombinant topical hemostat.”

ZymoGenetics reported significantly higher revenues in the first quarter of 2008. Revenues for the quarter were $13.5 million, compared to $5.2 million for the first quarter of 2007. The increase resulted from revenues related to the RECOTHROM collaboration with Bayer Healthcare, milestone payments related to IL-20 and rFactor XIII, and initial RECOTHROM sales of $1.0 million.

Costs of product sales were approximately 11 percent of product sales and include only the costs of manufacturing and distributing RECOTHROM that were incurred subsequent to FDA approval. All manufacturing related costs for RECOTHROM prior to FDA approval were expensed to research and development as incurred.

Research and development expenses were $39.2 million in the first quarter of 2008, compared to $29.8 million in the first quarter of 2007. The primary increases were due to expansion of the atacicept clinical program to include multiple disease indications and registrational studies in lupus, and $2.0 million of severance costs related to the company’s February 2008 restructuring.

Selling, general and administrative expenses were $14.6 million in the first quarter of 2008, a $4.9 million increase from the first quarter of 2007. The increase was primarily due to the deployment of the RECOTHROM sales force and marketing costs associated with the first quarter 2008 U.S. launch of RECOTHROM.


Net other expense in the first quarter of 2008 was $0.4 million, compared to $1.0 million net other income for the first quarter of 2007. The decrease reflects lower investment income, which was driven by lower cash balances to invest and decreased interest rates.

Business Highlights

ZymoGenetics' product development and commercialization programs have advanced this year, including the following highlights:

RECOTHROM

  • Received FDA approval for RECOTHROM Thrombin, topical (Recombinant) 5,000 IU vial size.
  • Submitted a Prior Approval Supplement application to FDA for approval of a 20,000 IU vial size to be sold both separately and co-packaged with a spray kit.
  • Shipped initial inventories of RECOTHROM to wholesale distributors.
  • Began selling RECOTHROM to hospitals.
  • Began contract negotiations with group purchasing organizations, the federal government and large hospital networks.

Atacicept

  • Completed a Special Protocol Assessment agreement with the FDA for a Phase 2/3 clinical trial in general systemic lupus erythematosus.
  • Began screening patients with general systemic lupus erythematosus for enrollment in the Phase 2/3 study.
  • Continued enrolling patients in the Phase 2/3 lupus nephritis clinical trial and in two Phase 2 rheumatoid arthritis clinical trials.
  • Began a Phase 2 clinical trial to evaluate the safety and efficacy of atacicept in patients with relapsing multiple sclerosis.
  • Initiated a Phase 2 clinical trial evaluating the safety and efficacy of atacicept and Rituxan® in rheumatoid arthritis patients receiving re-treatment with Rituxan.

IL-21

  • Began treating patients in a Phase 2 study in combination with Nexavar® (sorafenib) tablets in renal cell carcinoma patients.
  • Continued enrolling patients with metastatic melanoma in a Phase 2 study in collaboration with the National Cancer Institute of Canada.

PEG-Interferon lambda

  • Completed enrollment of the first cohort in a Phase 1b study evaluating the safety and antiviral activity in chronic genotype-1 hepatitis C patients who have relapsed after prior therapy.

Conference Call and Webcast Information

ZymoGenetics Q1 2008 Financial Results Conference Call will be held on May 6, 2008, at 4:30 p.m. Eastern Time and may be accessed at www.zymogenetics.com or by dialing 877-407-0782 (International: 201-689-8567). Participants should dial in to the call approximately 10 minutes prior to the scheduled start time to register. A live webcast of the presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 30 days.

For replay, please visit www.zymogenetics.com or use the following information:

  • U.S. callers: 877-660-6853
  • International callers: 201-612-7415

Replay passcode account #: 286

Conference ID #: 281899


About ZymoGenetics

ZymoGenetics creates novel protein drugs with the potential to significantly help patients fight their diseases. The company is developing a diverse pipeline of potential proprietary product candidates that are moving into and through clinical development. These candidates span a wide array of clinical opportunities that include bleeding, autoimmune and viral diseases and cancer. ZymoGenetics intends to commercialize these product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit www.zymogenetics.com.

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. ZymoGenetics' actual results and the timing and outcome of events may differ materially from those expressed in, or implied by, the forward-looking statements because of risks associated with our unproven product sales and marketing capabilities, manufacturing and commercialization capabilities, product safety, regulatory oversight, intellectual property claims and litigation and other risks detailed in the company's public filings with the Securities and Exchange Commission, including the company's most recent Annual Report on Form 10-K for the year ended December 31, 2007. Except as required by law, ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.

Nexavar® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.

Rituxan® (rituximab) is a registered trademark of Genentech, Inc., and Biogen Idec Inc.


ZYMOGENETICS, INC.

STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(Unaudited)
 
Three Months Ended
March 31,
  2008       2007  
Revenues:
Product sales, net $ 986 $
Royalties 1,534 1,950
Collaborations   10,992     3,232  
Total revenues 13,512 5,182
Costs and expenses:
Costs of product sales 106
Research and development 39,248 29,768
General and administrative   14,627     9,695  
Total costs and expenses   53,981     39,463  
Loss from operations (40,469 ) (34,281 )
Other (loss) income, net   (427 )   972  
Net loss $ (40,896 ) $ (33,309 )
Basic and diluted net loss per share $ (0.60 ) $ (0.49 )
Weighted-average number of shares used in
computing net loss per share   68,619     67,718  
BALANCE SHEETS
(in thousands)
 
March 31, December 31,
2008 2007
(unaudited)

Cash, cash equivalents and short-term investments

$ 155,066 $ 170,941
Inventory 3,292
Other current assets

20,403

11,841
Property and equipment, net 65,006 70,701
Other assets   7,812   9,598
Total assets $ 251,579 $ 263,081
 
Current liabilities $ 52,903 $ 63,960
Lease obligations 67,122 67,044
Other non-current liabilities

52,837

17,247
Shareholders’ equity  

78,717

  114,830
Total liabilities and shareholders’ equity $ 251,579 $ 263,081

CONTACT:
ZymoGenetics, Inc.
Investor & Media Relations:
Susan W. Specht, MBA, 206-442-6592
Director, Corporate Communications

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