WALTHAM, Mass., June 8 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the fourth quarter and fiscal
year ended March 31, 2006. Total revenue for fiscal year 2006 was
$12,911,000 compared to total revenue of $9,360,000 for the fiscal year
ended March 31, 2005, an increase of $3,551,000. Product revenue for fiscal
year 2006 consisting of Protein A and SecreFlo(R) sales, was $12,529,000
compared to $9,360,000 for fiscal year 2005, an increase of 34%. Gross
profit on product revenue for fiscal year 2006 was $8,978,000 (72%)
compared to $5,472,000 (58%) for fiscal year 2005. The increase in product
revenue was primarily due to higher customer demand. Profit margin was
impacted favorably by higher revenue and the decreased royalty owed for
SecreFlo(R), our secretin product which is marketed to gastroenterologists
for diagnosis of pancreatitis and gastrinoma, a rare form of cancer.
Operating expenses for the fiscal year ended March 31, 2006 were
$14,131,000 compared to $13,522,000 for the same period in fiscal year
2005. Operating loss for the fiscal year ended March 31, 2006 was
$1,220,000 compared to $4,162,000 for the same period in fiscal year 2005.
Net income for fiscal year 2006 was $697,000 or $.02 per share, compared to
a net loss of $2,984,000 or $.10 per share for fiscal year 2005. Cash and
investments as of March 31, 2006 were $23,408,000 compared to $23,523,000
on March 31, 2005.
"We are pleased to report that we have achieved our financial guidance,
and our operational performance is consistent with our objective to build a
self-sustaining, integrated biopharmaceutical company," stated Walter C.
Herlihy, President and Chief Executive Officer of Repligen Corporation.
"Profits from our product sales are being reinvested in the development of
our product pipeline, the expansion of our manufacturing capacity and in
the maintenance and enforcement of our intellectual property rights."
Total revenue for the fourth quarter of fiscal year 2006 was $2,885,000
compared to $2,995,000 for the same period in fiscal year 2005, a decrease
of 4%. Gross profit on product revenue for the fourth quarter of fiscal
year 2006 was $1,955,000 (69%) compared to $1,972,000 (66%) for the fourth
quarter of fiscal year 2005. Operating expenses for the fourth quarter of
fiscal year 2006 were $3,899,000 compared to $3,544,000, for the fourth
quarter of fiscal year 2005. The net loss for the fourth quarter of fiscal
year 2006 was $820,000 or $.03 per share, compared to a net loss of
$427,000 or $.01 per share for the fourth quarter of fiscal year 2005.
Update on Product Development Programs
Secretin
* Secretin is a gastrointestinal hormone involved in the process of
digestion, which has also been shown to have activity in the central
nervous system. Secretin signals the release of fluids into the ducts
of the pancreas, a result that has been documented in the literature to
improve MRI imaging of the pancreas. Following discussions with the
FDA on the criteria for approval to market our synthetic human secretin
product (RG1068) for improvement of MRI imaging of the pancreas, we
have initiated a clinical study to evaluate the use of secretin to aid
in the detection of structural abnormalities of the pancreas. 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.
* We have completed enrollment in a pilot study to assess the impact of
secretin on a surrogate marker for a cognitive deficit characteristic
of patients with schizophrenia. A preliminary review of the blinded
data suggests that while there may be an effect of drug treatment,
further analysis of the data will be necessary to understand the
potential impact of secretin on this patient population.
Uridine
* In February, we announced that we had initiated a Phase 2 clinical trial
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. Patients will be
evaluated for the safety and effectiveness of uridine in treating the
symptoms of bipolar depression. This study is being conducted under a
development agreement with the Stanley Medical Research Institute under
which Repligen will receive approximately $1,000,000 in funding. The
Stanley Medical Research Institute is the largest nonprofit provider of
funding for research on schizophrenia and bipolar disorder in the
United States.
Intellectual Property
* In January, 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 therapeutic methods. Repligen
has exclusive rights to this patent from its owners, the University of
Michigan and the U.S. Navy and we intend to seek a royalty bearing
license agreement with Bristol whether through litigation or
negotiation. In February, Bristol answered the complaint and
counterclaimed seeking a judgment that the patent is invalid and
unenforceable and that Bristol does not infringe the patent.
* Repligen and MIT previously filed suit against ImClone, alleging that
ImClone has infringed U.S. patent No. 4,663,281 in its production of
Erbitux(R). In February, the Court heard oral argument on summary
judgment motions brought by plaintiffs Repligen and MIT and defendant
ImClone on the issue of exhaustion of patent rights. The Court may: 1)
rule in Repligen's favor, dismissing ImClone's patent exhaustion
defense and send the case to trial, 2) deny both parties motions and
send the case to trial, or 3) rule in ImClone's favor and dismiss
Repligen's suit, subject to appeal. We hope for a ruling soon on the
summary judgment motions but there is no deadline by which the Court
must act.
Quarterly Conference Call
Walter C. Herlihy, Ph.D., will host a conference call and webcast on
Thursday, June 8th at 11:00 a.m. EDT, to report fourth quarter and fiscal
year 2006 financial results. This call may be accessed via Repligen's
website at http://www.repligen.com or you may listen to the live broadcast
by dialing (866) 356-3095 for domestic calls and (617) 597-5391 for
international calls, enter passcode: 95035956.
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(R), 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,
2006 2005 2006 2005
____________________________________________________
Revenue:
Product revenue $2,843,000 $2,995,000 $12,529,000 $9,360,000
Other revenue 42,000 - 382,000 -
___________ ___________ ___________ ___________
Total revenue 2,885,000 2,995,000 12,911,000 9,360,000
Operating expenses:
Cost of product
revenue 888,000 1,023,000 3,551,000 3,888,000
Research and
development 1,413,000 1,334,000 5,163,000 5,037,000
Selling, general
and
administrative 1,598,000 1,187,000 5,417,000 4,597,000
___________ ___________ ___________ ___________
Total operating
expenses 3,899,000 3,544,000 14,131,000 13,522,000
Income (loss)
from operations (1,014,000) (549,000) (1,220,000) (4,162,000)
Interest expense (3,000) - (3,000) -
Investment income 197,000 122,000 750,000 428,000
Other income - - 1,170,000 750,000
___________ ___________ ___________ __________
Net income (loss) $(820,000) $(427,000) $697,000 $(2,984,000)
=========== =========== =========== ===========
Earnings Per Share:
Basic and diluted $(0.03) $(0.01) $0.02 $(0.10)
=========== =========== =========== ===========
Weighted average
shares outstanding:
Basic 30,202,000 30,080,000 30,125,000 30,062,000
========== =========== =========== ===========
Diluted 30,202,000 30,080,000 30,691,000 30,062,000
========== =========== =========== ===========
Balance Sheet Data:
As of March 31,
2006 2005
__________________________
Cash and marketable securities* $23,408,000 $23,523,000
Total assets 28,599,000 27,607,000
Stockholders' equity 25,433,000 24,290,000
*does not include restricted cash
This release contains forward-looking statements which are made
pursuant to the safe harbor provisions of Section 21E of the Securities
Exchange Act of 1934. 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, management's strategy, plans and objectives
for future operations, clinical trials and results, product development and
manufacturing plans and performance such as the anticipated growth in the
monoclonal antibody market, projected growth in product sales,
opportunities for collaboration and licensing, and our intellectual
property portfolio 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.
CONTACT:
Walter C. Herlihy, Ph.D.
President and Chief Executive Officer
(781) 419-1900
Laura Whitehouse
Vice President, Market Development
(781) 419-1812
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
Corporation
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