-----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, Ci/wwAM9/RGDc+FJuJono/2IEY7T6fAJs74H3MDydW1fyUZwdgONNgSKDwdEwDCu aU6tdevlYsgAuc3hcSv1Yg== 0001157523-04-004583.txt : 20040507 0001157523-04-004583.hdr.sgml : 20040507 20040507170038 ACCESSION NUMBER: 0001157523-04-004583 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040506 ITEM INFORMATION: ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040507 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: 04789895 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 a4635310.txt ZYMOGENETICS 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, 2004 Date of Report (Date of earliest event reported) -------------- ZymoGenetics, Inc. (Exact name of registrant as specified in its charter) Washington 0-33489 91-1144498 (State or other Jurisdiction (Commission (IRS Employer of Incorporation) File Number) Identification Number) 1201 Eastlake Avenue East Seattle, Washington 98102-3702 (Address of principal executive offices) (Zip Code) 206-442-6600 (Registrant's telephone number, including area code) N/A (Former Name or Former Address, if Changed Since Last Report) Item 7. Financial Statements, Pro Forma Financial Information And Exhibits. (c) Exhibits. Exhibit 99.1 - Press Release dated May 6, 2004 of ZymoGenetics, Inc. Item 12. Results of Operations and Financial Condition On May 6, 2004, the Registrant issued a press release announcing its results of operations and financial condition for the three months ended March 31, 2004. 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. 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 hereunto duly authorized. ZYMOGENETICS, INC. Date: May 6, 2004 By: /s/ JAMES A. JOHNSON ------------------------------ Name: James A. Johnson Title: Senior Vice President and Chief Financial Officer EXHIBIT INDEX Exhibit Document Description Number - ------- -------------------- 99.1 Press release dated May 6, 2004 of ZymoGenetics, Inc. EX-99 2 a4635310ex991.txt PRESS RELEASE EXHIBIT 99.1 ZymoGenetics Reports First Quarter 2004 Financial Results SEATTLE--(BUSINESS WIRE)--May 6, 2004--ZymoGenetics, Inc. (Nasdaq:ZGEN) today reported its financial results for the first quarter ended March 31, 2004. The company reported a net loss for the quarter of $18.9 million, or $0.36 per share, reflecting continuing investment in its pipeline of product candidates. For the first quarter of 2003, ZymoGenetics had a net loss of $13.5 million, or $0.29 per share. The company ended the quarter in a strong financial position, with $285.0 million of cash and investments. "ZymoGenetics is off to a good start in 2004," stated Bruce L.A. Carter, president and CEO. "We have made significant progress with the start of rhThrombin Phase 2 clinical trials, completion of a Phase 1 trial of TACI-Ig in healthy volunteers, the filing and clearance of our IND application for IL-21, and the completion of an important licensing agreement for IL-20," added Dr. Carter. Revenues for the quarter decreased by 9% to $5.7 million, compared to $6.2 million for the same period in the prior year. The decrease resulted from lower license fees and milestone payments. Revenues recorded in the 2003 quarter included a milestone payment from Novo Nordisk related to development of IL-21 outside North America. In the 2004 quarter, the company received a $4 million upfront payment related to an IL-20 license, but $3.6 million of this amount has been deferred and will be recognized as revenue over the remainder of 2004. Operating expenses for the quarter increased, as expected. Expenses increased by 20% to $24.6 million, compared to $20.5 million for the first quarter of 2003. The increase largely resulted from higher costs related to the company's product development programs. ZymoGenetics is developing a broad pipeline of proprietary therapeutic protein product candidates and expects shortly to begin clinical trials of its fourth product candidate, IL-21. The company has ramped up its development efforts significantly over the past year, both through the addition of experienced personnel and the expansion of outsourced development work, such as process development, manufacturing and preclinical testing. Company Highlights To date in 2004, ZymoGenetics has taken a number of important steps in support of its business plan, including the following: -- Completed patient treatment in a Phase 1 rhThrombin clinical trial and began Phase 2 clinical studies of rhThrombin, which will address the control of bleeding in four different surgical settings: liver resection, lumbar spine surgery, lower extremity peripheral artery bypass surgery, and formation of vascular access grafts for dialysis. -- Together with its collaborator Serono, completed treatment of subjects in a Phase 1 clinical trial of TACI-Ig, examining the effects of treatment in healthy volunteers. -- Filed an IND application for Interleukin 21 (IL-21) and received agreement from the Food and Drug Administration to begin a Phase 1 clinical study examining the effects of IL-21 in treating metastatic melanoma and renal cell carcinoma patients. -- Completed a license agreement with Novo Nordisk A/S, granting exclusive rights in North America to ZymoGenetics' patents covering Interleukin 20 (IL-20) for which the company received a $4 million initial license fee, along with potential milestone and royalty payments. About ZymoGenetics ZymoGenetics is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic proteins for the prevention or treatment of human diseases. The Company is developing a diverse pipeline of potential proprietary product candidates that are moving into and through clinical development. These span a wide array of clinical opportunities that include bleeding, autoimmune 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 discovery strategy, preclinical and clinical development, 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 Annual Report on Form 10-K for the year ended December 31, 2003. 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. ZYMOGENETICS, INC. STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (Unaudited) Three Months Ended March 31, ------------------ 2004 2003 ------------------ Revenues: Royalty revenue $2,410 $2,396 Option fee 1,875 1,875 License fees and milestone payments 1,404 1,962 ------------------ Total revenues 5,689 6,233 Operating expenses: Research and development, excluding noncash stock-based compensation 20,033 15,675 General and administrative, excluding noncash stock-based compensation 2,965 3,094 Noncash stock-based compensation expense 1,572 1,766 ------------------ Total operating expenses 24,570 20,535 ------------------ Loss from operations (18,881) (14,302) Other income (expense), net (15) 831 ------------------ Net loss $(18,896)$(13,471) ================== Basic and diluted net loss per share $(0.36) $(0.29) ================== Weighted-average number of shares used in computing net loss per share 52,701 45,871 ================== BALANCE SHEETS (in thousands) (Unaudited) March 31, December 31, 2004 2003 -------------- ------------- Cash, cash equivalents and short-term investments $284,998 $299,892 Other current assets 8,834 8,652 Property and equipment, net 65,756 62,341 Other assets 5,218 5,024 -------------- ------------- Total assets $364,806 $375,909 ============== ============= Current liabilities $22,212 $21,131 Lease obligation 50,666 50,570 Construction advance from landlord 11,793 7,918 Other non-current liabilities 8,405 8,375 Shareholders' equity 271,730 287,915 -------------- ------------- Total liabilities and shareholders' equity $364,806 $375,909 ============== ============= CONTACT: ZymoGenetics, Inc. Susan W. Specht, 206-442-6592 -----END PRIVACY-ENHANCED MESSAGE-----