WALTHAM, Mass., Nov. 8 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the second quarter of fiscal year
2008, ended September 30, 2007. Total revenue for the quarter was
$5,352,000 compared to $2,865,000 for the second quarter of fiscal year
2007 ended September 30, 2006, an increase of $2,487,000 or 87%. Total
revenue for the quarter consisted primarily of Protein A product revenue.
Gross profit on product revenue for the second quarter of fiscal year 2008
was $3,744,000 (73%) compared to $1,765,000 (66%) for the same period in
fiscal year 2007, an increase of $1,979,000 or 112%.
During the second quarter of fiscal year 2008, the Company reached a
settlement with ImClone Systems in the patent infringement lawsuit against
ImClone related to the manufacture and sale of Erbitux(R). As a result of
the Settlement Agreement, the Company recorded a net gain from litigation
settlement of $40,170,000 as a separate component of operating expenses.
Operating expenses, exclusive of the net gain from litigation
settlement, were $4,752,000 for the second quarter of fiscal year 2008
compared to $3,961,000 for the same period in fiscal year 2007. This
increase in operating expenses of $791,000 was primarily the result of
other litigation expenses as well as increased external research and direct
material expenses, which were partially offset by lower clinical operations
costs.
Net income for the second quarter of fiscal year 2008 was $40,306,000
or $1.29 per diluted share, compared to a net loss for the second quarter
of fiscal year 2007 of $863,000 or $.03 per share. Cash, cash equivalents
and marketable securities as of September 30, 2007 were $62,696,000
compared to $22,627,000 as of March 31, 2007.
"We are very pleased to have monetized one of our intellectual property
assets and that our Protein A business continues to provide a growing
stream of revenue and profits," stated Walter C. Herlihy, President and
Chief Executive Officer of Repligen Corporation. "Our financial strength
will allow us to vigorously invest in our CTLA4 intellectual property, our
Protein A business and our product pipeline without the financial risks
normally associated with a clinical stage biotechnology company."
For the six-month period ended September 30, 2007, total revenue was
$11,331,000 compared to $6,493,000 for the same period in fiscal year 2007.
Gross profit on product revenue for the six-month period ended September
30, 2007 was $7,761,000 (71%) compared to $4,135,000 (68%) for the same
period in fiscal year 2007. Net gain from litigation settlement for the
six-month period ended September 30, 2007 was $40,170,000. Operating
expenses, exclusive of the net gain from litigation settlement, were
$10,746,000 for the six-month period ended September 30, 2007 compared to
$7,710,000 for the same period in fiscal year 2007. Net income for the
six-month period ended September 30, 2007 was $40,546,000 or $1.30 per
diluted share compared to a net loss of $763,000 or $.03 per share in the
same period in fiscal year 2007.
Corporate Update
Secretin for Imaging of the Pancreas
In September, we had a meeting with the FDA to discuss the positive
results of our Phase 2 clinical study of RG1068, synthetic human secretin,
for MRI imaging of the pancreas as well as the FDA's requirements for
registration. Based on our discussion with the FDA, we believe that a
single, well-controlled Phase 3 clinical trial which reproduces the Phase 2
study will be sufficient for product registration. We are currently
finalizing the Phase 3 protocol and related documents and plan to initiate
the Phase 3 study in the first quarter of 2008. 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 Disorder
Today we reported the results from our Phase 2 clinical trial of
RG2417, an oral formulation of uridine, in bipolar disorder. This was a
multi-center study in which 84 patients received RG2417 or a placebo over a
6-week period. The objective of the study was to assess the safety and
efficacy of RG2417 on the symptoms of bipolar depression as measured by the
co-primary endpoints, the Montgomery-Asberg Depression Rating Scale (MADRS)
and the Clinical Global Impression of Change in Bipolar Disorder scale
(CGI-BP-C). Patients were evaluated at baseline and then weekly using these
standardized tools to assess change in their symptoms. Over the six-week
treatment period, the study demonstrated a statistically significant
improvement in the symptoms of depression in the patients receiving RG2417
when compared to placebo on the MADRS (p=0.03) and a strong trend toward
improvement on the CGI-BP-C (p=0.06). This study was conducted under a
development agreement with the Stanley Medical Research Institute.
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. We have
synthesized and evaluated more than 100 compounds for their activity and
have identified several with improved potency and specificity. We are
continuing to evaluate this family of compounds for activity in animal
models of Friedreich's ataxia and other neurodegenerative diseases. In
September, we received a $100,000 research grant from the Friedreich's
Ataxia Research Alliance (FARA) to support some of the research activities.
FARA is a non- profit organization dedicated to the pursuit of scientific
research leading to treatments and a cure for Friedreich's ataxia.
Intellectual Property
ImClone Litigation Settlement
In September, we announced settlement with ImClone Systems,
Incorporated (ImClone) in the lawsuit against ImClone for infringement of
U.S. Patent No. 4,663,281 based on ImClone's manufacture and sale of
Erbitux(R). The settlement provided for ImClone to pay $65 million to
co-plaintiffs Repligen and The Massachusetts Institute of Technology (MIT)
which resulted in net proceeds to Repligen of approximately $40 million
after payment of obligations to MIT and legal expenses.
CTLA4-Ig Patent
In 2006, Repligen and The University of Michigan filed a lawsuit
against Bristol-Myers Squibb (Bristol) for infringement of a U.S. patent
that covers a method of treating rheumatoid arthritis with CTLA4-Ig.
Bristol markets CTLA4- Ig for treatment of rheumatoid arthritis, under the
brand name Orencia(R). Recently, the Court held a Markman hearing in order
to interpret the meaning of the claims in the patent. In its ruling on
claims construction, the Court rejected Bristol's attempt to insert a
mechanistic limitation on the use of CTLA4-Ig for the treatment of
rheumatoid arthritis and accepted our straightforward reading of the claim.
We anticipate that Summary Judgment briefing will be complete in February
and a trial will occur in April.
Quarterly Conference Call
Walter C. Herlihy, Ph.D., will host a conference call and webcast on
Thursday, November 8th at 11:00 a.m. EST, to review second quarter fiscal
year 2008 financial results and expectations and 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 (800) 591-6945 for domestic calls and (617)
614-4911 for international calls. Participants must provide the following
passcode: 91810104. For those who cannot participate in the live conference
call, an archive of the audio webcast will be available shortly after the
call and may be accessed at http://www.repligen.com.
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
Operating Statement Data:
Three months ended Six months ended
September 30, September 30,
2007 2006 2007 2006
Revenue:
Product revenue $5,156,000 $2,680,000 $10,888,000 $6,043,000
Other revenue 196,000 185,000 443,000 450,000
Total revenue 5,352,000 2,865,000 11,331,000 6,493,000
Operating expenses:
Cost of product
revenue 1,412,000 915,000 3,127,000 1,908,000
Research and
development 1,154,000 1,583,000 3,291,000 2,798,000
Selling, general
and administrative 2,186,000 1,463,000 4,328,000 3,004,000
Net gain from
litigation
settlement (40,170,000) - (40,170,000) -
Total operating
expenses (35,418,000) 3,961,000 (29,424,000) 7,710,000
Income (loss)
from operations 40,770,000 (1,096,000) 40,755,000 (1,217,000)
Investment income 366,000 236,000 623,000 460,000
Interest expense (3,000) (3,000) (5,000) (6,000)
Income (loss)
before taxes 41,133,000 (863,000) 41,373,000 (763,000)
Income tax provision 827,000 - 827,000 -
Net income (loss) $40,306,000 $(863,000) $40,546,000 $(763,000)
Earnings (loss) per share:
Basic $1.31 $(0.03) $1.32 $(0.03)
Diluted $1.29 $(0.03) $1.30 $(0.03)
Weighted average
shares outstanding:
Basic 30,767,000 30,364,000 30,667,000 30,361,000
Diluted 31,224,000 30,364,000 31,150,000 30,361,000
Balance Sheet Data:
Cash and marketable
securities * $62,696,000 $22,627,000
Total assets 70,803,000 29,076,000
Total stockholders'
equity 68,821,000 25,538,000
* does not include restricted cash
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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