WALTHAM, Mass., Nov. 2 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the second quarter of fiscal year
2007, ended September 30, 2006. Total revenue for the second quarter,
consisting primarily of Protein A and SecreFlo(R) sales, was $2,865,000
compared to total revenue of $2,800,000 for the second quarter of fiscal
year 2006. Gross profit on product revenue for the second quarter of fiscal
year 2007 was $1,765,000 (66%) compared to $1,844,000 (68%) for the second
quarter of fiscal year 2006.
Operating expenses for the second quarter of fiscal year 2007 were
$3,961,000 compared to $3,480,000 for the same period in fiscal year 2006.
This increase in operating expenses of $481,000 was primarily the result of
increased personnel, stock based compensation and clinical trial expenses.
The Company adopted Statement of Financial Accounting Standards No. 123R as
of April 1, 2006. As a result, the Company is recording compensation
expense for stock options awarded to employees in its Statement of
Operations in fiscal year 2007. The total expense recorded for the quarter
ended September 30, 2006 was $255,000. There was no expense recorded for
the comparable quarter ended September 30, 2005.
The net loss for the second quarter of fiscal year 2007 was $863,000 or
$0.03 per share, compared to a net loss of $468,000 or $0.02 per share for
the same period in fiscal year 2006. Cash and marketable securities as of
September 30, 2006 were $22,034,000 compared to $23,408,000 as of March 31,
2006.
"We are pleased to have made progress this quarter in developing our
pipeline and prosecuting our intellectual property while maintaining a
relatively low burn rate," stated Walter C. Herlihy, President and Chief
Executive Officer of Repligen Corporation.
For the six-month period ended September 30, 2006, total revenue was
$6,493,000 compared to $7,038,000 for the same period in fiscal year 2006,
a decrease of $545,000 or 8%. Gross profit on product revenue for the
six-month period was $4,135,000 (68%) compared to $4,882,000 (73%) for the
same period in fiscal year 2006. Operating expenses for the six-month
period were $7,710,000 compared to $6,838,000 for the same period in fiscal
year 2006. The Company recorded approximately $504,000 in stock based
compensation expense in the six-month period ending September 30, 2006,
with no comparable expense in fiscal year 2006. The net loss for the
six-month period was $763,000 or $0.03 per share compared to a net income
of $1,719,000 or $.06 per share in the same period in fiscal year 2006.
Update on Product Development Programs
Protein A
This quarter, we completed the final phase of expansion of our
manufacturing facility with increased capabilities and capacity. The
construction of this multi-thousand liter E. coli fermentation suite
enables the complete manufacture of recombinant biologics, such as
recombinant Protein A, including fermentation, recovery, purification,
packaging, quality control and quality assurance at our facility in
Waltham, Massachusetts. Previously this year, we completed the construction
of a third large-scale purification suite, which allows us to increase our
manufacturing throughput in excess of 200 kilograms of recombinant protein
each year.
Secretin
Earlier this week we reported the initiation of a clinical study to
evaluate the diagnostic utility of RG1068, synthetic human secretin, in
functional magnetic resonance imaging (MRI) of the pancreas. This study is
designed to confirm and quantify the clinical observation that patients
with pancreatic disease have reduced pancreatic fluid production in
response to stimulation by secretin, which may be useful in early diagnosis
of chronic pancreatitis. In June we announced the initiation of a clinical
trial to evaluate the use of secretin to aid in the detection of structural
abnormalities of the pancreas. All 16 of the clinical sites in this study
have been initiated and we anticipate that patients will be enrolled by the
end of the year. We believe there may be more than 100,000 potential MRI
images of the pancreas in the U.S. each year that could benefit from the
use of secretin to detect structural abnormalities.
Uridine
We are currently conducting a Phase 2 clinical trial of RG2417, an oral
formulation of uridine in bipolar depression. This is a multi-center, dose
escalating study in which 80 patients will receive either an oral
formulation of uridine or a placebo for 6 weeks. We have enrolled
approximately 40% of the patients with 9 open sites and we expect to
complete enrollment in this study by the end of the first quarter of next
year.
Intellectual Property
Previously, Repligen and The University of Michigan jointly filed a
complaint against Bristol-Myers Squibb Company (Bristol) (NYSE: BMY) in the
United States District Court for the Eastern District of Texas for
infringement of U.S. Patent No. 6,685,941 for the commercial sale of
Orencia(R). The patent entitled "Methods of Treating Autoimmune Disease via
CTLA4-Ig," covers methods of using CTLA4-Ig to treat rheumatoid arthritis,
as well as other autoimmune diseases. The judge will hold a scheduling
conference on November 16th, which will establish the initial timeline for
the case.
Repligen and The Massachusetts Institute of Technology (MIT) previously
filed suit against ImClone Systems, Inc. (ImClone) (NASDAQ: IMCL) alleging
that ImClone's production of Erbitux(R) infringes U.S. Patent No.
4,663,281, which covers certain genetic elements that increase protein
production in a mammalian cell. On July 28, 2006, the United States
District Court for the District of Massachusetts issued a Summary Judgment
ruling in favor of Repligen and MIT and rejected ImClone's defense of
patent exhaustion, thereby eliminating ImClone's patent exhaustion argument
as a potential defense for ImClone at trial. ImClone has previously
reported that it produced approximately $1 billion worth of Erbitux(R)
prior to the expiration of the patent-in-suit in 2004. We are currently
seeking patent term extension for this patent, which if granted could
significantly increase the value of our infringement claim against ImClone.
In addition, in March, Repligen and MIT filed a motion against ImClone
seeking sanctions based on conduct that in our view constituted
intimidation of a central witness in the case. In September, the Court held
an evidentiary hearing on this motion, and we are currently waiting for the
judge's decision in this matter.
Quarterly Conference Call
Repligen will host a conference call and webcast on Thursday, November
2nd at 11:00 a.m. EST, to report second quarter 2007 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 (800) 573-4754 for domestic calls and (617) 224-4325 for
international calls. Participants must provide the following passcode:
77094999.
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 currently market two commercial products,
Protein A and SecreFlo(R), 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:
Operating Statement Data:
Three months ended Six months ended
September 30, September 30,
2006 2005 2006 2005
Revenue:
Product revenue $2,680,000 $2,716,000 $6,043,000 $6,728,000
Other revenue 185,000 84,000 450,000 310,000
Total revenue 2,865,000 2,800,000 6,493,000 7,038,000
Operating expenses:
Cost of product revenue 915,000 872,000 1,908,000 1,846,000
Research and development 1,583,000 1,325,000 2,798,000 2,514,000
Selling, general and
administrative 1,463,000 1,283,000 3,004,000 2,478,000
Total operating
expenses 3,961,000 3,480,000 7,710,000 6,838,000
Income (loss) from
operations (1,096,000) (680,000) (1,217,000) 200,000
Interest expense (3,000) - (6,000) -
Investment income 236,000 212,000 460,000 349,000
Other income - - - 1,170,000
Net income (loss) $ (863,000) $ (468,000) $(763,000) $1,719,000
Earnings Per Share:
Basic and diluted $(0.03) $(0.02) $(0.03) $0.06
Weighted average
shares outstanding:
Basic 30,364,000 30,098,000 30,361,000 30,096,000
Diluted 30,364,000 30,098,000 30,361,000 30,607,000
September 30, March 31,
2006 2006
Balance Sheet Data:
Cash and marketable
securities* $22,034,000 $23,408,000
Total assets 28,093,000 28,599,000
Stockholders' equity 25,193,000 25,433,000
*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, Vice
President, Market Development, +1-781-419-1812, both of Repligen
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