PRESS RELEASE: Repligen Reports Second Quarter 2005 Financial Results
Tuesday November 9, 4:10 pm ET
Conference Call on Thursday November 11th at 11:00 A.M. EST
WALTHAM, Mass., Nov. 9 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN - News) 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
SOURCE: Yahoo News (press release)
http://biz.yahoo.com/prnews/041109/netu048_1.html
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