TKT Reports First Quarter 2001 Financial Results

Apr 30, 2001, 01:00 ET from Transkaryotic Therapies, Inc.

    CAMBRIDGE, Mass., April 30 /PRNewswire/ -- Transkaryotic Therapies, Inc.
 (Nasdaq:   TKTX) reported today financial results for the quarter ended March
 31, 2001.  For the first quarter of 2001, the Company had a net loss of
 $14,032,000, or $0.62 per share, compared to a net loss of $13,099,000, or
 $0.58 per share, for the first quarter of 2000.  License and research revenues
 in the first quarter of 2001 totaled $1,218,000; there were no license and
 research revenues in the first quarter of 2000. Operating expenses for the
 first quarter of 2001 were $21,465,000, compared to operating expenses of
 $15,721,000 for the corresponding period in 2000. Included in the increase in
 operating expenses is an increase of $1,123,000 in sales and marketing
 expenses related to the anticipated launch of the Company's first product,
 Replagal(TM), for the treatment of Fabry disease.  During the first quarter of
 2001, TKT sold substantially all of its investment in a European biotechnology
 company resulting in a gain of $2,785,000.  At the quarter end, March 31,
 2001, TKT had approximately $220,708,000 in cash and marketable securities.
     "During the first quarter, we made excellent progress toward the European
 approval of Replagal for the treatment of Fabry disease.  In March, the
 Committee for Proprietary Medicinal Products (CPMP) issued a positive opinion
 recommending approval in Europe.  Following approval by the European
 Commission, which is expected mid-year, we believe Replagal will be the
 product of choice among patients and physicians," said Richard F Selden, M.D.,
 Ph.D., President and Chief Executive Officer of TKT.
 
     Upcoming Events
     Health Care Conference Participation: TKT will provide shareholders with
 an update on the Company's research and development and business activities at
 Deutsche Banc Alex. Brown's 26th Annual Health Care Conference being held May
 8 - 10, 2001 in Baltimore, Maryland.  The TKT presentation will be webcast
 live over the Internet on Wednesday, May 9, 2001 from 4:30 p.m. to 5:00 p.m.
 EDT.  For a live and on-demand webcast of TKT's presentation go to the
 Deutsche Banc Alex. Brown website at http://www.db.com/conferences.  The
 presentation webcast will be archived on the Deutsche Banc Alex. Brown website
 for those who were unable to hear it live.
     Clinical Data Presentation: Clinical results of Replagal, TKT's
 investigational enzyme replacement therapy for the treatment of Fabry disease
 will be presented at the 10th International Congress of Human Genetics  (ICHG)
 being held May 15-19, 2001 in Vienna, Austria. These results were generated
 from a trial, which focused on cardiac improvement in patients with Fabry
 disease, conducted at Royal Free Hospital in the United Kingdom. Copies of the
 abstract will be available on the ICHG website beginning on or about May 10,
 2001 at www.ichg2001.org.
     Annual Shareholder Meeting: TKT's 2001 Annual Shareholders Meeting will be
 held on Thursday, June 14, 2001 at 10:00 a.m. EDT at the offices of Hale and
 Dorr LLP, 60 State Street, Boston, Massachusetts.
 
     About TKT
     Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company
 dedicated to the development and commercialization of products based on its
 three proprietary development platforms: Gene-Activated(R) proteins, Niche
 Protein(TM) products, and Gene Therapy.  The Company's gene activation
 technology is a proprietary approach to the large-scale production of
 therapeutic proteins, which does not require the cloning of genes and their
 subsequent insertion into non-human cell lines. TKT's Niche Protein product
 platform is based on protein replacement for the treatment of rare genetic
 diseases, a group of disorders characterized by the absence of certain
 metabolic enzymes.  The Company's Gene Therapy technology, known as
 Transkaryotic Therapy(TM), is focused on the commercialization of non-viral,
 ex vivo gene therapy products for the long-term treatment of chronic protein
 deficiency states.
     This press release contains forward-looking statements that involve a
 number of risks and uncertainties.  For this purpose, any statements contained
 herein that are not statements of historical fact may be deemed to be forward-
 looking statements.  Without limiting the foregoing, the words, "believes,"
 "anticipates," "plans," "expects,"  "estimates," "intends," "should," "could,"
 "will," "may," and similar expressions are intended to identify forward-
 looking statements. 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 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, 2000 which is on file with the Securities and Exchange
 Commission and incorporated herein by reference.   These include, without
 limitation, the following: (1) whether any of the Company's Gene-Activated
 protein, Niche Protein or gene therapy product candidates will advance in the
 clinical trial process, (2) whether such clinical trials will proceed in a
 timely manner, (3) whether the clinical trial results will warrant continued
 product development, (4) whether the required regulatory filings, such as
 Investigational New Drug applications and Biologics License Applications, are
 made in a timely manner, (5) whether the Company's products will receive
 approval from the U.S. Food and Drug Administration or equivalent foreign
 regulatory agencies, (6) if such products receive approval, whether they will
 be successfully distributed and marketed, (7) whether patent litigation in
 which the Company is involved or may become involved are resolved in a manner
 adverse to the Company, (8) the effects of competitive products on the
 Company's proposed products, and (9) the Company's dependence on third
 parties, including collaborators, manufacturers and distributors.
     These selected financial data should be read in conjunction with the
 consolidated financial statements and notes thereto included in the Company's
 Annual Report on Form 10-K for the year ended December 31, 2000.
 The Company's financial results may fluctuate from quarter to quarter based on
 changes in the progress of research and development efforts, the receipt, if
 any, of additional license fees and milestone payments, the timing of certain
 expenses, and the establishment of additional collaborative research
 agreements.
 
 
 - Financial Exhibit Follows -
 
                         Transkaryotic Therapies, Inc.
                Condensed Consolidated Statements of Operations
                    (in thousands, except per share amounts)
 
                                                          Three Months Ended
                                                              March 31,
                                                         2001           2000
 
     License and research revenues                     $1,218             $0
     Operating expenses:
     Research and development                          16,506         12,684
     Selling, general and administrative                4,959          3,037
 
                                                       21,465         15,721
 
     Operating loss                                  (20,247)       (15,721)
 
 
     Investment income                                  2,785              -
     Interest income, net                               3,430          2,622
 
     Net loss                                       ($14,032)      ($13,099)
 
     Basic and diluted net loss per share             ($0.62)        ($0.58)
     Shares used to compute basic
      and diluted net loss per share                   22,718         22,630
 
                       Condensed Consolidated Balance Sheets
                                   (in thousands)
 
                                                    March 31,   December 31,
                                                         2001           2000
 
     Cash and marketable securities                  $220,708       $245,456
     Other current assets                               2,527          1,842
     Property and equipment, net                       32,797         23,597
     Other assets                                       1,524          1,498
 
     Total assets                                    $257,556       $272,393
 
 
     Total current liabilities                        $13,601        $15,036
     Long-term debt, less current maturities            9,000          9,500
     Total stockholders' equity                       234,955        247,857
 
     Total liabilities and stockholders' equity      $257,556       $272,393
 
     Gene-Activated(R) is a registered trademark and Niche Protein(TM),
 Replagal(TM), TKT(TM), and Transkaryotic Therapy(TM) are trademarks of
 Transkaryotic Therapies, Inc.
         Please visit our web site at www.tktx.com for additional information
     about Transkaryotic Therapies, Inc.
 
     CONTACT:
     Justine E. Koenigsberg
     Director, Corporate Communications
     (617) 349-0271
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X12624747
 
 

SOURCE Transkaryotic Therapies, Inc.
    CAMBRIDGE, Mass., April 30 /PRNewswire/ -- Transkaryotic Therapies, Inc.
 (Nasdaq:   TKTX) reported today financial results for the quarter ended March
 31, 2001.  For the first quarter of 2001, the Company had a net loss of
 $14,032,000, or $0.62 per share, compared to a net loss of $13,099,000, or
 $0.58 per share, for the first quarter of 2000.  License and research revenues
 in the first quarter of 2001 totaled $1,218,000; there were no license and
 research revenues in the first quarter of 2000. Operating expenses for the
 first quarter of 2001 were $21,465,000, compared to operating expenses of
 $15,721,000 for the corresponding period in 2000. Included in the increase in
 operating expenses is an increase of $1,123,000 in sales and marketing
 expenses related to the anticipated launch of the Company's first product,
 Replagal(TM), for the treatment of Fabry disease.  During the first quarter of
 2001, TKT sold substantially all of its investment in a European biotechnology
 company resulting in a gain of $2,785,000.  At the quarter end, March 31,
 2001, TKT had approximately $220,708,000 in cash and marketable securities.
     "During the first quarter, we made excellent progress toward the European
 approval of Replagal for the treatment of Fabry disease.  In March, the
 Committee for Proprietary Medicinal Products (CPMP) issued a positive opinion
 recommending approval in Europe.  Following approval by the European
 Commission, which is expected mid-year, we believe Replagal will be the
 product of choice among patients and physicians," said Richard F Selden, M.D.,
 Ph.D., President and Chief Executive Officer of TKT.
 
     Upcoming Events
     Health Care Conference Participation: TKT will provide shareholders with
 an update on the Company's research and development and business activities at
 Deutsche Banc Alex. Brown's 26th Annual Health Care Conference being held May
 8 - 10, 2001 in Baltimore, Maryland.  The TKT presentation will be webcast
 live over the Internet on Wednesday, May 9, 2001 from 4:30 p.m. to 5:00 p.m.
 EDT.  For a live and on-demand webcast of TKT's presentation go to the
 Deutsche Banc Alex. Brown website at http://www.db.com/conferences.  The
 presentation webcast will be archived on the Deutsche Banc Alex. Brown website
 for those who were unable to hear it live.
     Clinical Data Presentation: Clinical results of Replagal, TKT's
 investigational enzyme replacement therapy for the treatment of Fabry disease
 will be presented at the 10th International Congress of Human Genetics  (ICHG)
 being held May 15-19, 2001 in Vienna, Austria. These results were generated
 from a trial, which focused on cardiac improvement in patients with Fabry
 disease, conducted at Royal Free Hospital in the United Kingdom. Copies of the
 abstract will be available on the ICHG website beginning on or about May 10,
 2001 at www.ichg2001.org.
     Annual Shareholder Meeting: TKT's 2001 Annual Shareholders Meeting will be
 held on Thursday, June 14, 2001 at 10:00 a.m. EDT at the offices of Hale and
 Dorr LLP, 60 State Street, Boston, Massachusetts.
 
     About TKT
     Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company
 dedicated to the development and commercialization of products based on its
 three proprietary development platforms: Gene-Activated(R) proteins, Niche
 Protein(TM) products, and Gene Therapy.  The Company's gene activation
 technology is a proprietary approach to the large-scale production of
 therapeutic proteins, which does not require the cloning of genes and their
 subsequent insertion into non-human cell lines. TKT's Niche Protein product
 platform is based on protein replacement for the treatment of rare genetic
 diseases, a group of disorders characterized by the absence of certain
 metabolic enzymes.  The Company's Gene Therapy technology, known as
 Transkaryotic Therapy(TM), is focused on the commercialization of non-viral,
 ex vivo gene therapy products for the long-term treatment of chronic protein
 deficiency states.
     This press release contains forward-looking statements that involve a
 number of risks and uncertainties.  For this purpose, any statements contained
 herein that are not statements of historical fact may be deemed to be forward-
 looking statements.  Without limiting the foregoing, the words, "believes,"
 "anticipates," "plans," "expects,"  "estimates," "intends," "should," "could,"
 "will," "may," and similar expressions are intended to identify forward-
 looking statements. 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 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, 2000 which is on file with the Securities and Exchange
 Commission and incorporated herein by reference.   These include, without
 limitation, the following: (1) whether any of the Company's Gene-Activated
 protein, Niche Protein or gene therapy product candidates will advance in the
 clinical trial process, (2) whether such clinical trials will proceed in a
 timely manner, (3) whether the clinical trial results will warrant continued
 product development, (4) whether the required regulatory filings, such as
 Investigational New Drug applications and Biologics License Applications, are
 made in a timely manner, (5) whether the Company's products will receive
 approval from the U.S. Food and Drug Administration or equivalent foreign
 regulatory agencies, (6) if such products receive approval, whether they will
 be successfully distributed and marketed, (7) whether patent litigation in
 which the Company is involved or may become involved are resolved in a manner
 adverse to the Company, (8) the effects of competitive products on the
 Company's proposed products, and (9) the Company's dependence on third
 parties, including collaborators, manufacturers and distributors.
     These selected financial data should be read in conjunction with the
 consolidated financial statements and notes thereto included in the Company's
 Annual Report on Form 10-K for the year ended December 31, 2000.
 The Company's financial results may fluctuate from quarter to quarter based on
 changes in the progress of research and development efforts, the receipt, if
 any, of additional license fees and milestone payments, the timing of certain
 expenses, and the establishment of additional collaborative research
 agreements.
 
 
 - Financial Exhibit Follows -
 
                         Transkaryotic Therapies, Inc.
                Condensed Consolidated Statements of Operations
                    (in thousands, except per share amounts)
 
                                                          Three Months Ended
                                                              March 31,
                                                         2001           2000
 
     License and research revenues                     $1,218             $0
     Operating expenses:
     Research and development                          16,506         12,684
     Selling, general and administrative                4,959          3,037
 
                                                       21,465         15,721
 
     Operating loss                                  (20,247)       (15,721)
 
 
     Investment income                                  2,785              -
     Interest income, net                               3,430          2,622
 
     Net loss                                       ($14,032)      ($13,099)
 
     Basic and diluted net loss per share             ($0.62)        ($0.58)
     Shares used to compute basic
      and diluted net loss per share                   22,718         22,630
 
                       Condensed Consolidated Balance Sheets
                                   (in thousands)
 
                                                    March 31,   December 31,
                                                         2001           2000
 
     Cash and marketable securities                  $220,708       $245,456
     Other current assets                               2,527          1,842
     Property and equipment, net                       32,797         23,597
     Other assets                                       1,524          1,498
 
     Total assets                                    $257,556       $272,393
 
 
     Total current liabilities                        $13,601        $15,036
     Long-term debt, less current maturities            9,000          9,500
     Total stockholders' equity                       234,955        247,857
 
     Total liabilities and stockholders' equity      $257,556       $272,393
 
     Gene-Activated(R) is a registered trademark and Niche Protein(TM),
 Replagal(TM), TKT(TM), and Transkaryotic Therapy(TM) are trademarks of
 Transkaryotic Therapies, Inc.
         Please visit our web site at www.tktx.com for additional information
     about Transkaryotic Therapies, Inc.
 
     CONTACT:
     Justine E. Koenigsberg
     Director, Corporate Communications
     (617) 349-0271
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X12624747
 
 SOURCE  Transkaryotic Therapies, Inc.