-- 2002 Replagal(TM) Sales Total $35 Million --
CAMBRIDGE, Mass., March 31 /PRNewswire-FirstCall/--
Transkaryotic Therapies, Inc. (Nasdaq: TKTX) reported today financial results
for the fourth quarter and year ended December 31, 2002.
Replagal(TM) (agalsidase alfa) sales for the fourth quarter of 2002
increased to $11,969,000, a 52% increase over third quarter 2002 sales of
$7,873,000. For the year ended December 31, 2002, Replagal sales totaled
$34,682,000, an increase of $31,147,000 over 2001 sales of $3,535,000.
Net loss for the three months ended December 31, 2002 was $47,512,000, or
$1.36 per share, compared to a net loss of $19,278,000, or $0.67 per share,
for the fourth quarter of 2001. Included in the net loss for the fourth
quarter is an expense of $8,660,000, or $0.25 per share, relating to an
intellectual property agreement with Cell Genesys, Inc. In addition, TKT
recorded an asset impairment charge of $16,069,000, or $0.46 per share, in
connection with one of the company's manufacturing facilities.
Net loss for the year ended 2002 was $129,762,000, or $3.75 per share,
compared to a net loss of $70,243,000, or $2.78 per share for 2001. Included
in the net loss for the full year are charges totaling $50,729,000, or $1.47
per share, related to an intellectual property agreement with Cell Genesys and
an asset impairment charge.
At December 31, 2002, TKT had $256,708,000 in cash and marketable
securities.
"As we expected, sales for the fourth quarter of 2002 were back on track
after a slower than expected third quarter. The progress we made this past
year is a strong endorsement of Replagal by patients and physicians, which we
expect will allow us to generate continued growth and to maintain our leading
position in Europe," said Michael J. Astrue, President and Chief Executive
Officer of TKT.
Mr. Astrue continued, "We executed important changes necessary for our
long-term success, including a consolidation of our resources and refocus of
our product pipeline. We plan to build upon our experience with rare
diseases and concentrate our efforts in this area, with a near-term emphasis
on our Fabry disease and Hunter syndrome programs. We are hopeful that
several of our promising programs that fall outside of our core focus will
yield significant value through partnering, and we are aggressively looking
for out-licensing opportunities."
Conference Call and Webcast
TKT management will host a conference call today, Monday, March 31, 2003,
at 11:00 a.m. E.T. to discuss 2002 financial results. Participants may access
the call by dialing (973) 317-5319. The call will also be broadcast live over
the Internet at http://www.tktx.com under the Investor Information section.
A replay of this conference call will be available for two weeks,
beginning today, March 31, 2003, at 2:00 p.m. E.T., by dialing (973) 709-2089
and using the passcode 288510. The replay will also be available on the
Internet at http://www.tktx.com under the Investor Information section.
Selected 2002 Highlights and Recent Events
Replagal(TM) Enzyme Replacement Therapy
-- On January 14, 2003, the Endocrinologic and Metabolic Drugs Advisory
Committee concluded by a vote of 8 to 7 that the Replagal renal
pathology data were not adequate to serve as a surrogate marker to
predict clinical benefit in patients with Fabry disease. By a
unanimous vote, the Advisory Committee also concluded that the Replagal
clinical data did not provide substantial evidence of efficacy. TKT
continues to seek U.S. approval and intends to conduct a re-read of its
pathology data.
-- Following an annual assessment of Replagal in Europe, the Committee for
Proprietary Medicinal Products (CPMP) issued a positive opinion
reaffirming the favorable risk/benefit profile of Replagal.
-- The European Commission expanded Replagal's Summary of Product
Characteristics (SPC) to support its use in women with Fabry disease.
The expansion is effective in the 15 countries of the European Union,
and is the only product label to include women.
-- TKT commenced an open-label study in Germany to evaluate the safety and
efficacy of Replagal in pediatric patients.
-- TKT's partner, Sumitomo Pharmaceutical Co., Ltd., filed a New Drug
Application with the Japanese Ministry of Health, Welfare, and Labor
seeking marketing authorization of Replagal in Japan.
-- In January 2003, Replagal received an honorary award for therapeutic
progress in France by the magazine, La Revue Prescrire. This was the
highest award given in 2002 and is reserved for products that have
demonstrated therapeutic innovation in Europe.
Iduronate-2-Sulfatase Enzyme Replacement Therapy
-- At the 52nd Annual Meeting of the American Society of Human Genetics,
TKT's investigator reported Phase I/II results of iduronate-2-sulfatase
(I2S) for the treatment of Hunter syndrome showing that I2S
administration was generally well-tolerated and demonstrated evidence
of clinical activity in patients with Hunter syndrome. TKT expects to
commence pivotal testing of I2S during the second half of 2003.
Dynepo(TM) Gene-Activated(R) Erythropoietin
-- Dynepo received marketing authorization in the 15 countries of the
European Union. Aventis has not yet launched Dynepo in Europe.
Litigation News
-- In July 2002, the Court of Appeal in the United Kingdom issued a ruling
in favor of TKT and Aventis, reversing a lower Court's initial ruling
and finding that activities relating to Dynepo do not infringe Kirin-
Amgen's European patent. In February 2003, the House of Lords in the
United Kingdom agreed to review the case.
-- The United States Court of Appeals for the Federal Circuit remanded a
patent infringement suit brought by Amgen against Aventis and TKT
claiming that Dynepo infringed several U.S. patents to the District
Court for further consideration of certain validity and infringement
issues.
-- Applied Research Systems, ARS Holdings, N.V., a wholly owned subsidiary
of Serono International S.A., brought suit against TKT in the District
Court at The Hague in the Netherlands claiming that TKT's activities
relating to Replagal infringe European Patent No. 0 505 500, a patent
that has been revoked by the European Patent Office.
-- Several purported class action lawsuits were brought against TKT. The
complaints generally claim TKT made false and misleading statements
relating to Replagal.
Intellectual Property
-- TKT purchased a royalty-free exclusive license from Cell Genesys to
certain intellectual property relating to Cell Genesys' approach to
gene activation, covering up to 15 proteins.
-- TKT signed a royalty-free license agreement with Orphan Medical, Inc.
relating to variants of alpha-galactosidase A, the protein deficient in
patients with Fabry disease.
-- The company strengthened its intellectual property position with the
issuance of seven patents in 2002, relating primarily to TKT's approach
to gene activation and gene therapy. In February 2003, TKT expanded its
intellectual property estate in the area of lysosomal storage disorders
with the issuance of a third U.S. patent relating to alpha-L-
iduronidase for the treatment of Hurler syndrome.
Upcoming Events
-- TKT will provide investors with an update on the company's business
activities at two upcoming health care conferences:
-- Deutsche Bank's 28th Annual Health Care Conference, May 6-7, 2003 in
Baltimore, Maryland; and
-- Robert W. Baird's 2003 Growth Stock Conference on Wednesday, May 14,
2003 in Chicago, Illinois.
About TKT
TKT is a biotechnology company developing and commercializing human
proteins for a broad range of diseases, with a major focus on rare genetic
diseases. TKT currently markets one product, Replagal (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 for Replagal. Additional
information on TKT is available on the company's website at http://www.tktx.com.
This press release contains forward-looking information that involve a
number of risks and uncertainties, including statements regarding Replagal,
iduronate-2-sulfatase, and Dynepo, as well as statements containing the words
"believes," "anticipates," "plans," "expects," "will," 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 re-read of the Replagal
pathology data will yield results that satisfy the FDA's requirements for
accelerated approval; whether the FDA and other equivalent regulatory agencies
will approve Replagal on a timely basis, or at all; whether Replagal will
achieve commercial success; whether a competitive product for the treatment of
Fabry disease obtains orphan drug status in the United States; whether
iduronate-2-sulfatase will be safe and effective as a treatment for Hunter
syndrome; whether future trials of iduronate-2-sulfatase will be conducted;
whether the FDA and equivalent regulatory authorities will approve
iduronate-2-sulfatase on a timely basis, or at all; whether TKT will prevail
in the patent litigation relating to Dynepo and Replagal; whether TKT will be
able to successfully defend any lawsuit against it; whether the company will
enter into collaborative arrangements on favorable terms, or at all; and other
factors set forth under the caption "Risk Factors" in the company's Quarterly
Report on Form 10-Q for the quarter ended September 30, 2002, which factors
are on file with the Securities and Exchange Commission and are incorporated
herein by reference. The company does not undertake any obligation to update
any forward-looking statements.
Gene-Activated(R) is a registered trademark and Replagal(TM) is a
trademark of Transkaryotic Therapies, Inc. Dynepo(TM) is a trademark of
Aventis Pharma.
- Financial Charts Follow -
Transkaryotic Therapies, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
Three Months Ended Year Ended
December 31, December 31,
(in thousands, except 2002 2001 2002 2001
per share amounts)
Revenues:
Product sales $11,969 $2,701 $34,682 $3,535
License and research
revenues 1,166 731 1,818 2,653
13,135 3,432 36,500 6,188
Operating expenses:
Cost of goods sold 5,570 185 10,511 185
Research and
development 21,582 16,471 81,309 65,921
Intellectual property
license expense 8,660 - 34,660 -
Selling, general and
administrative 10,026 8,526 31,229 24,823
Impairment charge 16,069 - 16,069 -
61,907 25,182 173,778 90,929
Operating loss (48,772) (21,750) (137,278) (84,741)
Interest income, net 1,260 2,033 7,516 11,274
Gain on sale of
investment - 439 - 3,224
Net loss ($47,512) ($19,278) ($129,762) ($70,243)
Basic and diluted
net loss per share ($1.36) ($0.67) ($3.75) ($2.78)
Shares used to compute
basic and diluted net
loss per share 34,843 28,848 34,616 25,228
Condensed Consolidated Balance Sheets
(unaudited)
December 31, December 31,
(in thousands) 2002 2001
Cash and marketable securities $256,708 $399,754
Other current assets 41,784 14,141
Property and equipment, net 59,372 41,587
Other assets 1,942 2,225
Total assets $359,806 $457,707
Total current liabilities 35,939 21,544
Total stockholders' equity 323,867 436,163
Total liabilities and stockholders' equity $359,806 $457,707
CONTACT:
Justine E. Koenigsberg
Director, Corporate Communications
(617) 349-0271
SOURCE Transkaryotic Therapies, Inc.
 back to top
Related links:
http://www.tktx.com
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/19990913/TKTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
Company News On-Call:
http://www.prnewswire.com/comp/120657.html
CONTACT:
Justine E. Koenigsberg, Director, Corporate
Communications of Transkaryotic Therapies, Inc., +1-617-349-0271
|
