WALTHAM, Mass., Feb. 8 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the third quarter of fiscal year
2007, ended December 31, 2006. Total revenue for the third quarter,
consisting primarily of Protein A and SecreFlo(R) sales, was $3,882,000
compared to total revenue of $2,988,000 for the third quarter of fiscal
year 2006, an increase of $894,000 or 30%. Gross profit on product revenue
for the third quarter of fiscal year 2007 was $2,828,000 compared to
$2,141,000 for the third quarter of fiscal year 2006.
Operating expenses for the third quarter of fiscal year 2007 were
$4,139,000 compared to $3,394,000 for the same period in fiscal year 2006.
This increase in operating expenses of $745,000 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 stock compensation expense
recorded for the quarter ended December 31, 2006 was $137,000. There was no
stock compensation expense recorded for the comparable quarter ended
December 31, 2005.
The net loss for the third quarter of fiscal year 2007 was $20,000 or
$0.00 per share, compared to a net loss of $202,000 or $0.01 per share for
the same period in fiscal year 2006. Cash, cash equivalents and marketable
securities as of December 31, 2006 were $21,924,000 compared to $23,408,000
as of March 31, 2006.
"We are pleased to have recorded our second highest level of 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 CNS drugs without the financial
risks typically associated with an emerging biotech company."
For the nine-month period ended December 31, 2006, total revenue was
$10,375,000 compared to $10,026,000 for the same period in fiscal year
2006, an increase of $349,000 or 3%. Gross profit on product revenue for
the nine- month period was $6,964,000 compared to $7,023,000 for the same
period in fiscal year 2006. Operating expenses for the nine-month period
were $11,849,000 compared to $10,232,000 for the same period in fiscal year
2006. The Company recorded approximately $641,000 in stock-based
compensation expense in the nine-month period ending December 31, 2006,
with no comparable expense in fiscal year 2006. The net loss for the
nine-month period was $782,000 or $0.03 per share compared to a net income
of $1,517,000 or $0.05 per share in the same period in fiscal year 2006.
Update on Product Development Programs
Protein A
* This quarter, we initiated the qualification of our recently completed
multi-thousand liter E. coli fermentation suite, which enables us to
fully manufacture recombinant biologics, such as recombinant Protein A,
including fermentation, recovery, purification, packaging, quality
control and quality assurance at our facility in Waltham, Massachusetts.
Last year, we completed the construction of a third large-scale
purification suite, which increased our manufacturing throughput in
excess of 200 kilograms of recombinant protein each year.
Secretin
* This quarter we completed enrollment in a clinical trial to evaluate the
use of RG1068, synthetic human secretin, to aid in the detection of
structural abnormalities of the pancreas. In October, we reported the
initiation of a second 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 November we announced that the Office of Orphan
Products Development of the U.S. Food and Drug Administration granted
orphan drug designation to RG1068 for use with MRI of the pancreas.
Orphan drug designation qualifies Repligen for seven years of exclusive
marketing rights in the U.S. if Repligen is first to receive marketing
approval for this indication.
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 65% of the patients in the study.
Intellectual Property
* Repligen and The Massachusetts Institute of Technology (MIT) previously
filed suit against ImClone Systems, Inc. (ImClone) 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. 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 waiting for a trial date
from the court. In addition, in March of 2006, 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 the judge's decision in this matter. We also are
seeking patent term extension for this patent until May 2009, which if
granted could significantly increase the potential value of our
infringement claim against ImClone.
* Previously, Repligen and The University of Michigan jointly filed a
complaint against Bristol-Myers Squibb Company (Bristol) 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. In November, the judge held a scheduling
conference, which established the initial timeline for the case. We
plan to complete the discovery phase of the case during 2007.
Quarterly Conference Call
Repligen will host a conference call and webcast on Thursday, February
8th at 11:00 a.m. EST, to report third 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 (866) 362-5158 for domestic calls and (617) 597-5397 for
international calls. Participants must provide the following passcode:
48737268.
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:
Three months ended Nine months ended
December 31, December 31,
2006 2005 2006 2005
Revenue:
Product revenue $3,633,000 $2,958,000 $9,677,000 $9,686,000
Other revenue 249,000 30,000 698,000 340,000
Total revenue 3,882,000 2,988,000 10,375,000 10,026,000
Operating expenses:
Cost of product
revenue 805,000 817,000 2,713,000 2,663,000
Research and
development 1,674,000 1,236,000 4,472,000 3,750,000
Selling, general
and administrative 1,660,000 1,341,000 4,664,000 3,819,000
Total
operating
expenses 4,139,000 3,394,000 11,849,000 10,232,000
Loss from operations (257,000) (406,000) (1,474,000) (206,000)
Interest expense (3,000) - (9,000) -
Investment income 240,000 204,000 701,000 553,000
Other income - - - 1,170,000
Net income (loss) $(20,000) $(202,000) $(782,000) $1,517,000
Earnings Per Share:
Basic and
diluted $(0.00) $(0.01) $(0.03) $0.05
Weighted average shares
outstanding:
Basic 30,376,000 30,105,000 30,361,000 30,099,000
Diluted 30,376,000 30,105,000 30,361,000 30,667,000
December 31, March 31,
2006 2006
Balance Sheet Data:
Cash, cash equivalents
and marketable
securities* $21,924,000 $23,408,000
Total assets 28,892,000 28,599,000
Stockholders' equity 25,310,000 25,433,000
*does not include restricted cash
Operating Statement Data:
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
 back to top
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
Corporation
|
