35% Increase in Annual Revenue
WALTHAM, Mass., May 25 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the fourth quarter and fiscal year
ended March 31, 2005. Total revenue for the fiscal year was $9,360,000
compared to total revenue of $6,914,000 for the fiscal year ended March 31,
2004, an increase of $2,446,000 or 35%. Total revenue for the year consisted
primarily of rProtein A(TM) sales and SecreFlo(TM) sales. Gross profit for
the fiscal year 2005 was $5,472,000 (58%) compared to $3,666,000 (53%) for the
fiscal year 2004.
Operating expenses for the fiscal year ended March 31, 2005 were
$9,634,000 compared to $13,607,000 for the same period in fiscal year 2004.
This decrease in operating expenses of $3,973,000 was primarily the result of
decreased research and development costs related to the discontinuation of our
Phase 3 clinical trials in autism as well as a one time non-cash charge of
$2,413,000 in fiscal year 2004 related to the write off of the goodwill
associated with the termination of the SecreFlo(TM) license agreement. The
net loss for fiscal year 2005 was $2,984,000 or $.10 per share, compared to
$9,551,000 or $.32 per share for fiscal year 2004. Cash and investments as of
March 31, 2005 were $24,041,000 compared to $24,863,000 as of March 31, 2004.
Total revenue for the fourth quarter of fiscal year 2005 was $2,995,000
compared to $2,113,000 for the same period in fiscal year 2004, an increase of
42%. Gross profit for the fourth quarter of fiscal year 2005 was $1,972,000
(66%) compared to $1,243,000 (59%) for the fourth quarter of fiscal year 2004.
Operating expenses for the fourth quarter of fiscal year 2005 were $2,521,000
compared to $4,597,000, for the fourth quarter of fiscal year 2004. The net
loss for the fourth quarter of fiscal year 2005 was $427,000 or $.01 per
share, compared to a net loss of $3,257,000 or $.11 per share for the fourth
quarter of fiscal year 2004, including a non-cash charge in fiscal year 2004
of $2,413,000 related to the write off of the goodwill associated with the
termination of the SecreFlo(TM) license.
"During this year we have achieved record product sales," stated Walter C.
Herlihy, President and Chief Executive Officer of Repligen Corporation. "We
are committed to building shareholder value through a prudent business
strategy in which the growing profits from current product sales enable us to
develop our intellectual property and our pipeline of neurology drugs without
the financial risks typically associated with an emerging biotech company."
Update on Product Development Programs
Secretin
In February we reported initial data from our Phase 2 study of secretin in
patients with refractory schizophrenia. This study produced mixed results
with a trend toward improvement in a physician's assessment, however this
trend was not statistically significant. Several patients in this study
participated in a cognitive testing paradigm, which suggested further
investigation. We are designing a follow-up study to determine if this
observation is reproducible and related to drug treatment. We anticipate that
this study will be complete by the end of the year. In addition, we are
currently enrolling patients in a Phase 1 open-label study of secretin in an
anxiety disorder called Obsessive-Compulsive Disorder. We anticipate that
enrollment will be complete by the end of this year.
Uridine
In March we announced that we have entered into a development agreement
with the Stanley Medical Research Institute under which Repligen has received
funding for our Phase 1 clinical trial to assess the oral bioavailability of
our proprietary formulation of uridine. This Phase 1 study is currently
enrolling patients and assuming adequate bioavailability, may be followed by a
placebo controlled trial in bipolar disorder in the second half of 2005. The
Stanley Medical Research Institute is the largest nonprofit provider of
funding for research on schizophrenia and bipolar disorder in the United
States.
Commercial Products
In February we announced the amendment of our 1999 Supply Agreement with
GE Healthcare governing the manufacture of GE Healthcare's recombinant Protein
A. The amendment extends the term of the agreement through 2010, expands the
manufacturing to include an additional GE Healthcare protein and anticipates a
mechanism for the manufacturing of future proteins. The protein separations
business of GE Healthcare is a leader in the development, production and
marketing of protein separations products, which are used in the manufacture
of over 90 percent of all marketed biopharmaceutical drugs, including
monoclonal antibodies.
In May we announced that we resolved a dispute with our supplier of
SecreFlo(TM), a diagnostic form of secretin, by entering into a Settlement
Agreement. Under the terms of the Settlement Agreement, we received a payment
of $750,000 and will continue to market SecreFlo(TM) for the next several
years under a favorable royalty structure.
Quarterly Conference Call
Walter C. Herlihy, Ph.D., will host a conference call and webcast on
Wednesday May 25th at 11:30 a.m. EDT, to report fourth quarter and fiscal year
2005 financial results and to provide a quarterly update of the Company. This
call can be accessed via Repligen's website at http://www.repligen.com. If
you are unable to access the webcast via the internet, you may also listen to
the live broadcast by calling (866) 800-8649 for domestic calls and (617) 614-
2703 for international calls. Participants must provide the following
passcode: 76699297.
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. 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 requested from
http://www.repligen.com.
SELECTED FINANCIAL DATA
Operating Statement Data:
Three-months ended Years ended
March 31, March 31,
2005 2004 2005 2004
Revenue:
Product revenue $2,995,000 $2,113,000 $9,360,000 $6,843,000
Grant revenue -- -- -- 71,000
Total revenue 2,995,000 2,113,000 9,360,000 6,914,000
Cost of revenue 1,023,000 870,000 3,888,000 3,248,000
Gross profit 1,972,000 1,243,000 5,472,000 3,666,000
Operating expenses:
Research and
development 1,334,000 1,304,000 5,037,000 6,484,000
Selling, general
and administrative 1,187,000 880,000 4,597,000 4,710,000
Impairment of long
term asset -- 2,413,000 -- 2,413,000
Total operating
expenses 2,521,000 4,597,000 9,634,000 13,607,000
Loss from operations (549,000) (3,354,000) (4,162,000) (9,941,000)
Investment income 122,000 97,000 428,000 390,000
Other income -- -- 750,000 --
Net loss $(427,000) $(3,257,000) $(2,984,000) $(9,551,000)
Basic and diluted net
loss per share $(.01) $(.11) $(.10) $(.32)
Basic and diluted
weighted average
shares outstanding 30,080,000 30,020,000 30,062,000 29,686,000
Balance Sheet Data:
March 31, 2005 March 31, 2004
Cash and investments $24,041,000 $24,863,000
Total assets 27,607,000 29,615,000
Stockholders' equity 24,290,000 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.
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, VP Market Development, +1-781-250-0111, ext. 2306,
both of Repligen Corporation
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