WALTHAM, Mass., Aug. 8 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the first quarter of fiscal year
2008, ended June 30, 2007. Total revenue for the quarter was $5,978,000
compared to total revenue of $3,628,000 for the first quarter of fiscal
year 2007 ended June 30, 2006, an increase of $2,350,000 or 65%. Total
revenue for the quarter consisted primarily of Protein A product revenue.
Gross profit on product revenue for the first quarter of fiscal year 2008
was $4,017,000 (70%) compared to $2,371,000 (70%) for the same time period
in fiscal year 2007, an increase of $1,646,000 or 69%.
Operating expenses for the first quarter of fiscal year 2008 were
$5,993,000 compared to $3,750,000 in the same time period in fiscal year
2007. This increase in operating expenses of $2,243,000 was primarily the
result of increased external research, licensing, litigation, and direct
material expenses.
The net profit for the first quarter of fiscal year 2008 was $240,000
or $.01 per share, compared to a net profit for the first quarter of fiscal
year 2007 of $100,000 or $.00 per share. Cash, cash equivalents and
marketable securities as of June 30, 2007 were $21,816,000 compared to
$22,627,000 as of March 31, 2007.
"We are pleased to have achieved our highest level of quarterly product
sales to date," stated Walter C. Herlihy, President and Chief Executive
Officer of Repligen Corporation. "We continue to execute on our strategy to
build shareholder value through prudent business management in which the
growing profits from current product sales enable us to develop our
intellectual property and our pipeline of drug candidates without many of
the financial risks typically associated with an emerging biotech company."
Corporate Update
Secretin for Imaging of the Pancreas
In May, we reported positive results from a Phase 2 clinical trial to
evaluate the use of RG1068, synthetic human secretin, as an agent to
improve the assessment of the pancreatic ducts by magnetic resonance
imaging (MRI). Detailed visual assessment of the pancreatic ducts and
identification of structural abnormalities is important in the assessment,
diagnosis and treatment of diseases such as acute and chronic pancreatitis.
We have prepared a detailed statistical report of the study for review by
the FDA. We plan to meet with the FDA in the fall to discuss the Phase 2
results, the Phase 3 trial design and the requirements for registration. We
believe there may be more than 100,000 pancreatic MRI imaging procedures
conducted in the U.S. each year that could benefit from the use of
secretin.
Uridine for Bipolar Depression
We have completed enrollment in our Phase 2 clinical trial of RG2417,
an oral formulation of uridine, in bipolar depression and expect to have
results in the fall. This is a multi-center study in which 84 patients
received an oral formulation of uridine or a placebo for 6 weeks.
Transcription Activators for Friedreich's Ataxia
In April, we acquired the rights to intellectual property covering
compounds which may have utility in treating Friedreich's ataxia.
Friedreich's ataxia is an inherited neurodegenerative disease in which low
levels of the protein frataxin result in progressive damage to the nervous
system and loss of muscle function. We are currently screening selected
compounds to determine if any have the appropriate pharmacologic and
toxicologic profile to be designated as a clinical candidate. In addition,
we are evaluating the compounds in several other animal models of
neurodegenerative disease.
Intellectual Property
Enhancer Patent
Repligen and MIT own rights to a U.S. patent, which covers certain
genetic elements that increase protein production in a mammalian cell.
Repligen and MIT filed an action against ImClone for infringement of this
patent based on ImClone's manufacture and sale of Erbitux(R). In the
complaint we allege that the cell line that ImClone uses to produce
Erbitux(R) employs a key technology that is claimed in the patent.
Recently, the Court imposed sanctions on ImClone for misconduct by its
attorneys. A jury trial is scheduled for September 10, 2007 in Boston.
ImClone has reported approximately $1.5 billion in sales to date of
Erbitux(R) in the U.S.
CTLA4-Ig Patent
Repligen licensed the exclusive rights to a U.S. patent owned by The
University of Michigan that covers a method of treating rheumatoid
arthritis with CTLA4-Ig that will remain in force until 2021. In 2005,
Bristol-Myers Squibb received FDA approval to market CTLA4-Ig for treatment
of rheumatoid arthritis, under the brand name Orencia(R). Subsequently,
Repligen and The University of Michigan filed a lawsuit against Bristol for
infringement of this patent. Our goal is to license patent rights to
Bristol in exchange for royalties whether through a court action or a
negotiated settlement. Analysts expect the annual sales of Orencia(R) to
reach $1 billion within five years. A trial is currently scheduled for
April 2008.
Quarterly Conference Call
Walter C. Herlihy, Ph.D., will host a conference call and webcast on
Wednesday August 8th at 11:00 a.m. EDT, to review first quarter of fiscal
year 2008 financial results and expectations to provide a quarterly update
of the Company. This call is being webcast and can be accessed via
Repligen's website at http://www.repligen.com or you may also listen to the
live broadcast by calling (866) 713-8395 for domestic calls and (617)
597-5309 for international calls, using passcode: 73944093.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the
development of novel therapeutics for diseases that affect the central nervous
system. In addition, we are the world's leading supplier of recombinant
Protein A, the sales of which partially fund the advancement of our
development pipeline while supporting our financial stability. 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
Three Months ended
June 30,
2007 2006
Revenue
Product revenue $5,731,000 $3,364,000
Other revenue 247,000 264,000
Total revenue 5,978,000 3,628,000
Operating expenses:
Cost of product revenue 1,714,000 993,000
Research and development 2,137,000 1,215,000
Selling, general and administrative 2,142,000 1,542,000
Total operating expenses 5,993,000 3,750,000
Income (loss) from operations (15,000) (122,000)
Investment income 257,000 225,000
Interest expense (2,000) (3,000)
Net income $240,000 $100,000
Earnings per share:
Basic and diluted $0.01 $0.00
Weighted average shares outstanding:
Basic 30,565,000 30,358,000
Diluted 31,128,000 30,826,000
As of June 30, As of March 31,
Balance Sheet Data: 2007 2007
Cash, cash equivalents and marketable
securities* $21,816,000 $22,627,000
Working capital 21,552,000 22,394,000
Total assets 29,911,000 29,076,000
Long-term obligations 195,000 200,000
Accumulated deficit (157,443,000) (157,683,000)
Stockholders' equity 26,386,000 25,538,000
*does not include restricted cash of $200,000
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, +1-781-419-1900, or Laura Whitehouse, VP
Market Development, +1-781-419-1812, both of Repligen Corporation
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