-- Replagal Sales Increase 43% Over First Quarter of 2003 --
CAMBRIDGE, Mass., April 27 /PRNewswire-FirstCall/ -- Transkaryotic
Therapies, Inc. (Nasdaq: TKTX) announced today its consolidated financial
results for the three months ending March 31, 2004. For the first quarter,
sales of Replagal(TM) (agalsidase alfa), TKT's enzyme replacement therapy for
the treatment of Fabry disease, were approximately $17.4 million. Sales
increased by approximately 43% over the $12.2 million in sales the company
recognized in the first quarter of 2003. Foreign currency fluctuations
contributed $2.4 million to first quarter 2004 product sales as compared to
the first quarter of 2003. Sales in the first quarter of 2004 increased 12%
compared with the fourth quarter of 2003. A reversal of a 2003 price discount
accrual during the first quarter of 2004 contributed approximately $0.5
million to first quarter 2004 product sales as the company determined it was
no longer probable that this amount would be paid to customers.
Total operating expenses were $31.9 million for the first quarter of 2004
and decreased by 17% from the first quarter of 2003. The decrease was due
primarily to the company's restructuring, initiated in the first quarter of
2003, which reduced costs and narrowed the scope of its research initiatives.
As a result of the restructuring, TKT recorded a restructuring charge of
approximately $3.6 million for the quarter ended March 31, 2003. In the first
quarter of 2004, the company recorded $861,000 in ongoing restructuring
charges primarily related to ongoing facility lease commitments.
The net loss for the first quarter was approximately $14.2 million, or
$0.41 per share, compared to a net loss of approximately $25.9 million, or
$0.75 per share, for the corresponding period in 2003. As of March 31, 2004,
TKT had approximately $164.6 million in cash and marketable securities.
Commenting on the first quarter of 2004, Michael J. Astrue, President and
Chief Executive Officer of TKT said, "2004 has been a year of significant
progress for TKT. We have regained rights to Dynepo outside the United
States, completed patient enrollment in the Hunter syndrome pivotal trial,
initiated enrollment for the GA-GCB trial, received Canadian approval of
Replagal, and continued to increase Replagal sales in Europe. Our goal is to
generate revenue from three products in 2006."
Conference Call and Webcast:
TKT invites the public to participate on a conference call and live
webcast with investment analysts beginning today, April 27, 2004 at 10:00 a.m.
Eastern Time to discuss its first quarter 2004 financial results and its
outlook for the balance of 2004. To participate by telephone, dial (973) 317-
5319. A live audio webcast can be accessed on the TKT web site at
http://www.tktx.com within the Investor Information section. A replay of the call
will be available for two weeks beginning at 1:00 p.m. Eastern Time on April
27, 2004 by dialing (973) 709-2089 and using the access code: 350896. A
replay of the webcast will be archived on the TKT web site under Events in the
Investor Information section for one year.
Product Development and Business Activities:
The following is a summary of selected highlights during the period
January 1, 2004 through April 27, 2004.
Replagal for Fabry Disease
-- TKT made the decision in January 2004 to discontinue its efforts to
seek U.S. approval of Replagal (agalsidase alfa), TKT's enzyme
replacement therapy for Fabry disease, where orphan drug exclusivity
excludes it from the market until April 2010.
-- Health Canada approved Replagal in February 2004. Canada became the
twenty-eighth country to approve Replagal.
-- TKT hired a country manager, based in Toronto, to support Canadian
launch activities with overall responsibility for Replagal sales and
marketing initiatives. The company also signed an exclusive
agreement with Paladin Labs of Montreal for distribution of Replagal
in Canada and certain post-marketing activities, such as medical
information support and reimbursement.
Dynepo(TM) for Anemia Associated with Kidney Disease
-- TKT announced in March 2004 that it had regained exclusive rights to
its Dynepo (epoetin delta) product outside the United States.
Dynepo received marketing approval in the European Union in March
2002. Subject to the establishment of manufacturing and commercial
capabilities for Dynepo in the European Union, TKT expects to offer
Dynepo for commercial sale in the Europe Union in late 2005 or early
2006.
Iduronate-2-Sulfatase for Hunter Syndrome
-- TKT completed enrollment in its pivotal trial evaluating its enzyme
replacement therapy, Iduronate-2-sulfatase (I2S), for the treatment
of Hunter syndrome in early March 2004. A total of ninety-six
patients enrolled in the study, exceeding the company's target of
ninety patients. TKT expects top-line results from this twelve-
month study in the second quarter of 2005 and that if the results
are positive, the company expects to submit applications for
marketing approval in the United States and the European Union
during the second half of 2005.
GA-GCB for Gaucher Disease
-- TKT initiated a Phase I/II clinical trial in April 2004 to evaluate its
GA-GCB enzyme replacement therapy for Gaucher disease. The study is
designed to evaluate safety and clinical activity of GA-GCB in twelve
patients with Gaucher disease with completion of the trial
anticipated in 2005.
Upcoming Health Care Conference Participation
-- TKT is scheduled to present at three health care conferences during the
second quarter of 2004. A live audio webcast and replay of these
presentations will be available through TKT's Investor Information
website at http://www.tktx.com:
* On May 5, 2004 at the Deutsche Bank Securities 29th Annual Health
Care Conference in Baltimore, Maryland.
* On May 19-21 at the Banc of America Securities LLC, 2004 Health
Care Conference in Las Vegas, Nevada.
* On June 9, 2004 at the Pacific Growth Equities Life Sciences
Growth Conference in San Francisco, California.
About TKT
Transkaryotic Therapies, Inc. is a biopharmaceutical company primarily
focused on researching, developing and commercializing treatments for rare
diseases caused by protein deficiencies. Within this focus, the company
markets Replagal(TM), an enzyme replacement therapy for Fabry disease, and is
developing treatments for Hunter syndrome and Gaucher disease. Outside its
focus on rare diseases, TKT intends to commercialize Dynepo(TM), its Gene-
Activated(R) erythropoietin product for anemia related to kidney disease,
outside of the United States. TKT was founded in 1988 and is headquartered in
Cambridge, Massachusetts, with additional operations in Europe, Canada and
Latin America. Additional information about TKT is available on the
company's website at http://www.tktx.com.
This press release contains forward-looking statements regarding TKT's
development of certain products, including Replagal, I2S, GA-GCB, Dynepo, and
the timing of clinical trials, clinical trial results and regulatory filings,
and statements regarding TKT's financial outlook, 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 any of the company's products
will achieve the commercial success anticipated by the company; whether
competing products will reduce the market opportunity for such products;
whether I2S will be safe and effective as a treatment for Hunter syndrome;
whether GA-GCB will be safe and effective as a treatment for Gaucher disease;
whether TKT will be able to successfully complete clinical trials of its
products; enrollment rates for clinical trials; whether the results of
clinical trials, will be indicative of results obtained in later clinical
trials; whether future clinical trials will be conducted and conducted on a
timely basis; the ability of TKT and its collaborators to successfully
complete development of its products; the ability to manufacture sufficient
quantities of its products to satisfy both clinical trial requirements and
commercial demand, if approved; the timing of submissions to and decisions by
regulatory authorities in the United States, Europe, Japan and other countries
regarding clinical trials and marketing and other applications; whether the
FDA and equivalent regulatory authorities grant marketing approval for the
company's products on a timeline consistent with TKT's expectations, or at
all; the availability and extent of coverage from third party payors and the
receipt of reimbursement approvals for the company's products; whether
competing products will reduce any market opportunity that may exist; whether
TKT will be successful in finding a collaborator for GA-GCB; results of
litigation; whether the company will be successful in establishing European
manufacturing for Dynepo; 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, 2003, 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.
Gene-Activated(R) is a registered trademark and Replagal(TM) is a
trademark of Transkaryotic Therapies, Inc. Dynepo(TM) is a trademark of
Aventis.
CONTACTS
Justine E. Koenigsberg Daniella M. Lutz
Director, Corporate Communications Corporate Communications Specialist
(617) 349-0271 (617) 349-0205
- Consolidated Financial Table To Follow -
Condensed Consolidated Statements of Operations (unaudited)
Three Months Ended March 31,
(In thousands, except per share
amounts) 2004 2003
Product sales $17,372 $12,169
License and research revenues 62 14
17,434 12,183
Operating expenses:
Cost of goods sold 2,236 3,501
Research and development 19,837 20,982
Intellectual property license
expense - 1,350
Selling, general and
administrative 8,958 9,166
Restructuring charges 861 3,602
31,892 38,601
Loss from operations before minority
interest (14,458) (26,418)
Minority interest in net income of
consolidated subsidiary (1) (303)
Loss from operations after minority
interest (14,459) (26,721)
Interest income 308 776
Net loss $(14,151) $(25,945)
Basic and diluted net loss per share $(0.41) $(0.75)
Shares used to compute basic and
diluted net loss per share 34,612 34,550
Condensed Consolidated Balance Sheets (unaudited)
March 31, December 31,
(In thousands) 2004 2003
Cash and marketable securities $164,634 $180,947
Other current assets 44,381 44,392
Property and equipment, net 64,644 61,908
Other assets 1,972 1,922
Total assets $275,631 $289,169
Total liabilities $33,336 $30,434
Minority interest 414 413
Total stockholders' equity 241,881 258,322
Total liabilities and
stockholders' equity $275,631 $289,169
SOURCE Transkaryotic Therapies, Inc.
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CONTACT:
Justine E. Koenigsberg, Director, Corporate
Communications, +1-617-349-0271, or Daniella M. Lutz, Corporate
Communications Specialist, +1-617-349-0205, both of Transkaryotic
Therapies, Inc.
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