-----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, NQ36OuhrDuJKpSRFgc4/NJVZulDR8DC3N5F6mmXJ0/8VDbFlQfpGouvFBHf6zDo4 GXenw9/gtJsl6stQYXHTBA== 0001047469-03-016558.txt : 20030505 0001047469-03-016558.hdr.sgml : 20030505 20030505081755 ACCESSION NUMBER: 0001047469-03-016558 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030505 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030505 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TRANSKARYOTIC THERAPIES INC CENTRAL INDEX KEY: 0000885259 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 043027191 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21481 FILM NUMBER: 03680992 BUSINESS ADDRESS: STREET 1: 195 ALBANY ST CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6173490200 8-K 1 a2110061z8-k.txt 8-K 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): May 5, 2003 Transkaryotic Therapies, Inc. - -------------------------------------------------------------------------------- (Exact name of registrant as specified in charter) Delaware 000-21481 04-3027191 - -------------------------------------------------------------------------------- (State or other juris- (Commission (IRS Employer diction of incorporation File Number) Identification No.) 700 Main Street 02139 Cambridge, MA - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (617) 349-0200 - -------------------------------------------------------------------------------- (Former name or former address, if changed since last report) ITEM 9. REGULATION FD DISCLOSURE (INFORMATION FURNISHED PURSUANT TO ITEM 12, "DISCLOSURE OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION"). On May 5, 2003, Transkaryotic Therapies, Inc. announced its financial results for the quarter ended March 31, 2003. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K. In accordance with the procedural guidance in SEC Release No. 33-8216, the information in this Form 8-K and the Exhibit attached hereto is being furnished under "Item 9. Regulation FD Disclosure" rather than under "Item 12. Disclosure of Results of Operations and Financial Condition." The information shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in any such filing. 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. Date: May 5, 2003 TRANSKARYOTIC THERAPIES, INC. By: /s/Michael J. Astrue ----------------------------------------- Michael J. Astrue President and Chief Executive Officer EXHIBIT INDEX
Exhibit No. Description - ----------- ----------- 99.1 Press release dated May 5, 2003
EX-99.1 3 a2110061zex-99_1.txt EXHIBIT 99.1 Exhibit 99.1 CONTACT: Justine E. Koenigsberg Director, Corporate Communications (617) 349-0271 FOR IMMEDIATE RELEASE TKT ANNOUNCES FIRST QUARTER 2003 FINANCIAL RESULTS CAMBRIDGE, MA, MAY 5, 2003 -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX) reported today consolidated financial results for the three months ended March 31, 2003. For the first quarter of 2003, Replagal(TM) (agalsidase alfa) sales were approximately $12.2 million. Sales increased by approximately 101% over the first quarter of 2002, which totaled approximately $6.1 million. The net loss for the first quarter was approximately $25.9 million, or $0.75 per share, compared to a net loss of approximately $18.5 million, or $0.54 per share, for the corresponding period in 2002. Included in the net loss for the first quarter of 2003 is an expense of approximately $1.4 million, or $0.04 per share, relating to an intellectual property agreement with Cell Genesys, Inc. During the quarter, TKT also announced a major reorganization in an effort to reduce costs and narrow the scope of its research initiatives. As a result, TKT recorded an initial restructuring charge of approximately $3.6 million, or $0.10 per share, consisting primarily of employee related severance costs as well as charges related to facility consolidation. The company expects to record additional restructuring charges during the remaining quarters of 2003, relating primarily to facility consolidation. At March 31, 2003, TKT had approximately $212 million in cash and marketable securities. "To date, Replagal has been the product of choice in Europe for Fabry disease, and we believe that clinical experience continues to confirm the benefits described in its European product label," said Michael J. Astrue, President and Chief Executive Officer of TKT. "We regret that patients in the United States do not have access to this important treatment option, and we will be consulting with the FDA in the coming months to determine our best opportunity for making Replagal available in the United States." CONFERENCE CALL AND WEBCAST In connection with this announcement, TKT will host a conference call and live webcast today, Monday, May 5, 2003, at 10:00 a.m. Eastern Time. Participants may access the call by dialing (973) 317-5319. The live webcast may be accessed in the Investor Information section of TKT's website at www.tktx.com. A replay of this conference call will be available beginning today, May 5, 2003, at 1:00 p.m. Eastern Time, by dialing (973) 709-2089 and using the access code 291927. A replay of the webcast will be archived on the TKT website in the Investor Information section. - more - Transkaryotic Therapies, Inc. TKT Announces First Quarter 2003 Results May 5, 2003 Page 2 ABOUT TKT TKT is a biopharmaceutical company developing therapeutics for the treatment of rare genetic diseases caused by protein deficiencies. The company currently markets one product, Replagal(TM) (agalsidase alfa) for the treatment of Fabry disease in the European Union and certain other countries. TKT is headquartered in Cambridge, Massachusetts and has a majority-owned subsidiary in Sweden, TKT Europe-5S AB, which is responsible for European sales and marketing activities of Replagal. Additional information on TKT is available on the Company's website at www.tktx.com. This press release contains forward-looking statements that involve a number of risks and uncertainties, including statements regarding Replagal, as well as statements containing the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions. There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including whether the FDA and other equivalent regulatory agencies will approve Replagal on a timely basis, or at all; whether Replagal will achieve commercial success; and other factors set forth under the caption "Certain Factors That May Affect Future Results" in the company's Annual Report on Form 10-K for the year ended December 31, 2002, which is on file with the Securities and Exchange Commission and which factors are incorporated herein by reference. While the company may elect to update forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so, even if its expectations change. REPLAGAL(TM) IS A TRADEMARK OF TRANSKARYOTIC THERAPIES, INC. - Financial Charts Follow - Transkaryotic Therapies, Inc. TKT Announces First Quarter 2003 Results May 5, 2003 Page 3
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) Three Months Ended March 31, ---------------------------------------------- (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) 2003 2002 --------------------- --------------------- Revenues: Product sales $12,183 $6,058 License and research revenues -- 552 --------------------- --------------------- 12,183 6,610 --------------------- --------------------- Operating expenses: Cost of goods sold 3,501 548 Research and development 20,982 20,409 Intellectual property license expense 1,350 -- Selling, general and administrative 9,166 6,423 Restructuring charge 3,602 -- --------------------- --------------------- 38,601 27,380 --------------------- --------------------- Operating loss (26,418) (20,770) Interest income 776 2,303 Minority interest in net income of consolidated subsidiary (303) -- --------------------- --------------------- Net loss ($25,945) ($18,467) ===================== ===================== Basic and diluted net loss per share ($0.75) ($0.54) ===================== ===================== Shares used to compute basic and diluted net loss per share 34,550 34,331 ===================== =====================
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) March 31, December 31, (IN THOUSANDS) -------------------- --------------------- 2003 2002 -------------------- --------------------- Cash and marketable securities $212,079 $256,708 Other current assets 43,064 41,784 Property and equipment, net 61,807 59,372 Other assets 1,863 1,942 -------------------- --------------------- Total assets $318,813 $359,806 ==================== ===================== Total current liabilities 22,262 35,939 Minority interest 303 -- Total stockholders' equity 296,248 323,867 -------------------- --------------------- Total liabilities and stockholders' equity $318,813 $359,806 ==================== =====================
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