Conference Call on Thursday November 11th at 11:00 A.M. EST
WALTHAM, Mass., Nov. 9 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the second quarter of fiscal year
2005 ended September 30, 2004. Total revenue for the quarter was $1,296,000
compared to total revenue of $1,419,000 for the second quarter of fiscal year
2004, a decrease of $123,000 or 9%. Gross profit for the second quarter of
fiscal year 2005 was $593,000 (46%) compared to $678,000 (48%) for the second
quarter of fiscal year 2004.
Operating expenses for the second quarter of fiscal year 2005 were
$2,413,000 compared to $2,912,000 for the second quarter of fiscal year 2004.
The net loss for the second quarter of fiscal year 2005 was $1,719,000 or $.06
per share, compared to $2,140,000 or $.07 per share for the second quarter of
fiscal year 2004. Cash and investments as of September 30, 2004 were
$24,004,000.
For the six-month period ended September 30, 2004 total revenue was
$4,106,000 compared to $3,480,000 for the same period in fiscal 2004, an
increase of $626,000 or 18%. Gross profit for the six-month period was
$2,270,000 (55%) compared to $1,884,000 (54%) for the same period in fiscal
year 2004. Operating expenses for the six-month period of fiscal year 2005
were $4,832,000 compared to $6,244,000 for the same period in fiscal year
2004. The net loss for the six-month period of fiscal year 2005 ended
September 30, 2004 was $2,364,000 or $.08 per share, compared to $4,168,000 or
$.14 per share for the same period of fiscal year 2004.
"Product sales for the first half of the year showed solid growth as
demand increased for our Protein A products used in the production of
monoclonal antibodies, consistent with the growth of the monoclonal antibody
market," stated Walter C. Herlihy, President and CEO of Repligen. "We intend
to continue to leverage the profits from our product sales, our intellectual
property assets and internal capabilities to develop our emerging CNS
pipeline."
Update on Product Development Programs
Secretin
* We have completed patient enrollment in a multi-dose, placebo-
controlled, Phase 2a clinical trial of secretin in schizophrenia. This
trial is designed to assess the impact of twice weekly dosing of two
different dose levels of secretin over two weeks to improve the
symptoms of schizophrenia when compared to placebo. We expect to
complete this trial by the end of the year.
* We initiated a Phase 1, open-label clinical trial of secretin in
Obsessive-Compulsive Disorder (OCD) in September. This open-label,
dose escalation study will enroll up to sixteen patients and will
evaluate the safety, tolerability and preliminary evidence of efficacy
of secretin on the symptoms of OCD including obsessive thoughts and
compulsive behaviors.
Uridine
We reported positive activity of uridine in validated animal models of
anxiety at the annual meeting of the Society for Neuroscience in October.
Published literature indicates that uridine is also active in animal models of
neurodegenerative diseases including Parkinson's and Huntington's disease. We
plan to submit an IND for a Phase 2a clinical trial of uridine in patients
with bipolar disorder in 2005.
Intellectual Property
CTLA4-Ig
Bristol-Myers Squibb Corporation presented the results of two positive
Phase 3 clinical trials of its form of CTLA4-Ig at the annual meeting of
the American College of Rheumatology in October. Bristol-Myers Squibb
has previously stated that it intends to file a New Drug Application for
CTLA4-Ig by the end of the year. We own the rights to a United States
patent for the use of CTLA4-Ig for the treatment of rheumatoid arthritis,
multiple sclerosis and lupus and a patent in Europe for the use of CTLA4-
Ig for the treatment of autoimmune disease including rheumatoid
arthritis, as well as organ transplant. These patents will remain in
force until 2021 and 2013 respectively.
Bioprocessing Technology
As previously disclosed, Repligen and MIT filed suit against ImClone on
May 4th alleging that ImClone has infringed one of our U.S. patents in
its production of Erbitux(R), also known as C225. In August, the judge
set the preliminary schedule for the suit, and we currently anticipate
that exchange of documents and deposition of fact witnesses will be
completed by the middle of 2005.
Quarterly Conference Call
Repligen's President and Chief Executive Officer, Walter C. Herlihy,
Ph.D., will host a conference call and webcast on Thursday November 11th at 11
a.m. EST, to provide a quarterly update of the Company's clinical development
programs and Specialty Pharmaceuticals business. This call can be accessed
via Repligen's website at http://www.repligen.com or you may listen to the
live broadcast by calling (800) 299-7635 for domestic calls and (617) 786-2901
for international calls and entering the passcode: 90559203.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company committed to being the
leader in the development of novel therapeutics for profound neuropsychiatric
disorders and autoimmune disease with particular emphasis on applications for
children. Repligen has a Specialty Pharmaceuticals business comprised of
rProtein A(TM) and SecreFlo(TM), the profits from which will be used to
partially support the development of our proprietary products. Repligen's
corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100,
Waltham, MA 02453. Additional information may be obtained from
http://www.repligen.com.
SELECTED FINANCIAL DATA
Operating Statement Data:
Three-months ended Six-months ended
September 30, September 30,
2004 2003 2004 2003
Revenue:
Product revenue $ 1,296,000 $ 1,383,000 $4,106,000 $3,426,000
Research revenue -- 36,000 -- 54,000
Total revenue 1,296,000 1,419,000 4,106,000 3,480,000
Cost of revenue 703,000 741,000 1,836,000 1,596,000
Gross profit 593,000 678,000 2,270,000 1,884,000
Operating expenses:
Research and
development 1,274,000 1,901,000 2,663,000 3,330,000
Selling, general
and administrative 1,139,000 1,011,000 2,169,000 2,914,000
Total operating
expenses 2,413,000 2,912,000 4,832,000 6,244,000
Loss from operations (1,820,000) (2,234,000) (2,562,000) (4,360,000)
Investment income 101,000 94,000 198,000 192,000
Net loss $(1,719,000) $(2,140,000)$(2,364,000)$(4,168,000)
Basic and diluted
net loss per share $(.06) $(.07) $(.08) $(.14)
Basic and diluted
weighted average
shares outstanding 30,058,000 28,860,000 30,051,000 29,423,000
Balance Sheet Data:
September 30, March 31,
2004 2004
Cash and investments $24,004,000 $24,863,000
Total assets 27,364,000 29,615,000
Stockholders' equity 24,878,000 27,164,000
This press release contains forward-looking statements which are made
pursuant to the safe harbor provisions of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. The forward-looking statements in this release do not constitute
guarantees of future performance. Investors are cautioned that statements in
this press release which are not strictly historical statements, including,
without limitation, statements regarding current or future financial
performance and position, management's strategy, plans and objectives for
future operations, plans and objectives for product development, plans and
objectives for present and future clinical trials and results of such trials,
plans and objectives for regulatory approval, litigation, intellectual
property, product development, manufacturing plans and performance such as the
anticipated growth in the monoclonal antibody market and our other target
markets and projected growth in product sales, constitute forward-looking
statements. Such forward-looking statements are subject to a number of risks
and uncertainties that could cause actual results to differ materially from
those anticipated, including, without limitation, risks associated with: the
success of current and future collaborative relationships, the market
acceptance of our products, our ability to compete with larger, better
financed pharmaceutical and biotechnology companies, new approaches to the
treatment of our targeted diseases, our expectation of incurring continued
losses, our uncertainty of product revenues and profits, our ability to
generate future revenues, our ability to raise additional capital to continue
our drug development programs, the success of our clinical trials, our ability
to develop and commercialize products, our ability to obtain required
regulatory approvals, our compliance with all Food and Drug Administration
regulations, our ability to obtain, maintain and protect intellectual property
rights for our products, the risk of litigation regarding our intellectual
property rights, our limited sales and manufacturing capabilities, our
dependence on third-party manufacturers and value added resellers, our ability
to hire and retain skilled personnel, our volatile stock price, and other
risks detailed in Repligen's filings with the Securities and Exchange
Commission. Repligen assumes no obligation to update any forward-looking
information contained in this press release or with respect to the
announcements described herein.
CONTACT:
Walter C. Herlihy, Ph.D.
President and Chief Executive Officer
(781) 250-0111, ext. 2000
Laura Whitehouse
Vice President, Market Development
(781) 250-0111, ext. 2306
SOURCE Repligen Corporation
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Related links:
http://www.repligen.com
CONTACT:
Walter C. Herlihy, Ph.D., President and Chief
Executive Officer, +1-781-250-0111, ext. 2000; or Laura
Whitehouse, Vice President, Market Development, +1-781-250-0111,
ext. 2306 both of Repligen Corporation
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