Third Quarter 2003 Revenue Increased 93% Over Last Year's Third Quarter
CAMBRIDGE, Mass., Oct. 29 /PRNewswire-FirstCall/ -- Transkaryotic
Therapies, Inc. (Nasdaq: TKTX) today reported consolidated financial results
for the three and nine months ended September 30, 2003.
Total revenues for the three and nine months ended September 30, 2003 were
$16.7 million and $43.3 million, respectively. Sales of Replagal(TM)
(agalsidase alfa) for the third quarter totaled $15.2 million, as compared to
$7.9 million for the same period in 2002. For the nine months ended September
30, 2003 and 2002, Replagal sales totaled $41.8 million and $22.7 million,
respectively.
For the quarter ended September 30, 2003, TKT's net loss was $13.6
million, or $0.39 per share, compared to a net loss of $20.9 million, or $0.60
per share, for the same period in 2002. For the nine months ended September
30, 2003 and 2002, the company's net loss was $60.5 million, or $1.75 per
share, and $82.3 million, or $2.38 per share, respectively.
As a result of the company's restructuring efforts announced in February
2003, TKT recorded charges of $2.8 million and $11.3 million during the three
and nine months ended September 30, 2003, respectively. The charges related
to employee severance and outplacement services, as well as charges relating
to facility consolidation. The restructuring charges contributed $0.08 and
$0.33 to net loss per share for the three and nine months ended September 30,
2003, respectively. For the nine months ended September 30, 2003 and 2002,
TKT also recorded an expense of approximately $1.4 million and $26.0 million,
respectively, relating to an intellectual property license agreement with Cell
Genesys, Inc. These charges contributed $0.04 and $0.75 to net loss per share
for the nine months ended September 30, 2003 and 2002, respectively.
TKT ended the quarter with approximately $188 million in cash and
marketable securities. During the quarter, the company used $10 million of
cash, primarily for its ongoing operating activities.
"I am very proud of what this company has accomplished," said Michael J.
Astrue, President and Chief Executive Officer of TKT. "In the past six months
we have cut expenses and increased Replagal revenues while maintaining our
focus on key programs."
Pipeline Update
TKT continues to advance its I2S, Replagal and GA-GCB products. Below is
an update on the status of its development programs and upcoming events.
I2S for Hunter Syndrome
* In September 2003, TKT began enrolling patients in its AIM study
(Assessment of I2S in MPS II) of I2S for Hunter syndrome, or MPS II.
TKT expects enrollment in the AIM study, previously anticipated by year-
end 2003, will be complete by February 2004.
* On October 8, 2003, Genzyme and TKT formed a collaboration under which
Genzyme will commercialize I2S in certain Asia/Pacific territories. As
part of the collaboration, TKT received a $1.5 million upfront payment
and has the potential to receive an additional $8 million in regulatory
and commercial milestones.
* At the Ninth International Congress of Inborn Errors of Metabolism in
Australia, TKT's lead clinical investigator presented long-term data
from TKT's Phase I/II I2S clinical trial which showed improvements in a
variety of clinical measures, including joint range of motion and the
six-minute walk test, and demonstrated a favorable safety profile.
Additional long-term data will be presented at the American Society of
Human Genetics Annual Meeting on November 6, 2003.
Replagal for Fabry Disease
* On October 8, 2003, Genzyme and TKT also signed a global legal
settlement in which the companies exchanged three non-suits and Genzyme
agreed to withdraw from its patent suit against TKT relating to
Replagal. On October 9, 2003, the Federal Circuit affirmed a finding of
non-infringement by TKT in the U.S. patent suit relating to Replagal.
TKT believes it is possible, but unlikely that the other plaintiff in
the suit will obtain further appellate review of this decision.
* On October 10, 2003, The Technical Board of Appeals of the European
Patent Office upheld the revocation of a Serono European patent. TKT
expects that dismissal of Serono's suit regarding such patent against
TKT in the Netherlands will be dismissed as a matter of course.
* Replagal received marketing authorization in Poland during the quarter
and is now approved for commercial use in 27 countries.
* In September 2003, the Pharmaceutical Benefits Advisory Committee in
Australia recommended that the Federal Minister of Health include
Replagal under the Life Saving Drug Category, which is an important step
toward receiving government reimbursement in Australia for Replagal. A
final decision on reimbursement approval in Australia is expected in the
first half of next year.
* TKT plans to submit a request for special protocol assessment to the FDA
next month in order to identify a regulatory approach that could lead to
approval of Replagal in the United States.
GA-GCB for Gaucher Disease
* TKT commenced discussions with potential partners to license its Gene-
Activated(R) glucocerebrosidase (GA-GCB) enzyme replacement therapy for
the treatment of Gaucher disease. The FDA has scheduled a pre-IND
meeting for mid-November 2003. TKT expects clinical testing to begin in
the second quarter of 2004.
Upcoming Events
* In conjunction with the American Society of Human Genetics Annual
Meeting in Los Angeles, California, TKT will host an investor event with
Dr. Joseph Muenzer, lead investigator of the I2S AIM Study, to discuss
I2S and Hunter syndrome, on Friday, November 7, 2003 from 8:30 am - 9:30
am Pacific Time. The meeting will be held at the Omni Los Angeles
Hotel. A live audio webcast may be accessed in the Investor Information
section of TKT's website at http://www.tktx.com.
* TKT will provide investors with an update on the company's product
pipeline and business activities at the Harris Nesbitt Gerard Healthcare
Conference on Thursday, December 11, 2003 in New York City. A live
audio webcast of this presentation may also be accessed in the Investor
Information section of TKT's website at http://www.tktx.com.
Conference Call and Webcast Information
In connection with this announcement, TKT will host a conference call and
live webcast today, Wednesday, October 29, 2003, at 10:00 a.m. Eastern Time to
discuss these financial results and the financial outlook for TKT.
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
http://www.tktx.com.
A replay of this conference call will be available for two weeks beginning
today, October 29, 2003, at 1:00 p.m. Eastern Time, by dialing (973) 709-2089
and using the access code 300864. The replay of the webcast will be archived
on the TKT website in the Investor Information section within the Events
category.
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 http://www.tktx.com.
This press release contains forward-looking statements regarding TKT's
development of certain products, including Replagal, I2S, and GCB, 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 Replagal will receive regulatory approval in Japan and other
countries; whether I2S will be safe and effective as a treatment for Hunter
syndrome; whether GCB will be safe and effective as a treatment for Gaucher
disease; whether TKT is 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 partners 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 partner for GCB; results of litigation; and other
factors set forth under the caption "Certain Factors That May Affect Future
Results" in the company's Quarterly Report on Form 10-Q for the quarter ended
June 30, 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.
- Financial Table Follows -
Transkaryotic Therapies, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2003 2002 2003 2002
(in thousands, except per share amounts)
Revenues:
Product sales $15,199 $7,873 $41,782 $22,713
License and research
revenues 1,519 17 1,533 652
16,718 7,890 43,315 23,365
Operating expenses:
Cost of goods sold 2,769 2,743 11,045 4,941
Research and
development 17,895 20,450 55,730 59,727
Intellectual property
license expense - - 1,350 26,000
Selling, general and
administrative 7,285 7,304 25,863 21,203
Restructuring charges 2,765 - 11,324 -
30,714 30,497 105,312 111,871
Operating loss (13,996) (22,607) (61,997) (88,506)
Interest income, net 412 1,705 1,784 6,256
Minority interest 31 - (305) -
Net loss $(13,553) $(20,902) $(60,518) $(82,250)
Basic and diluted
net loss per share $(0.39) $(0.60) $(1.75) $(2.38)
Shares used to
compute basic and
diluted net loss
per share 34,567 34,819 34,551 34,539
Condensed Consolidated Balance Sheets
(unaudited)
September 30, December 31,
2003 2002
(in thousands)
Cash and marketable securities $187,947 $256,708
Other current assets 42,578 41,784
Property and equipment, net 58,784 59,372
Other assets 1,818 1,942
Total assets $291,127 $359,806
Total current liabilities $25,615 $35,939
Minority interest 305 -
Total stockholders' equity 265,207 323,867
Total liabilities and stockholders' equity $291,127 $359,806
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
|
