Company Reports 31% Increase in Product Revenue
WALTHAM, Mass., Feb. 9 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the third quarter of fiscal year
2006 ended December 31, 2005. Total revenue for the quarter was $2,988,000
compared to total revenue of $2,260,000 for the third quarter of fiscal year
2005. Product revenue for the third quarter was $2,958,000 compared to
product revenue of $2,260,000 for the third quarter of fiscal year 2005, an
increase of 31%. Gross profit on product revenue for the third quarter of
fiscal year 2006 was $2,141,000 (72%), compared to $1,231,000 (54%) for the
same period in fiscal year 2005. The increase in product revenue was
primarily due to higher customer demand, while profit margin on product
revenue was impacted favorably by 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 third quarter of fiscal year 2006 ended
December 31, 2005 were $3,394,000 compared to $3,310,000 for the third quarter
of fiscal year 2005. The net loss for the third quarter of fiscal year 2006
was $202,000 or $.01 per share, compared to a net loss of $193,000 or $.01 per
share for the third quarter of fiscal year 2005. Cash and investments as of
December 31, 2005 were $23,076,000 compared to $23,523,000 on March 31, 2005.
"Our financial results are consistent with our business strategy 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 maintenance and
enforcement of our intellectual property rights, development of our product
pipeline and expansion of our manufacturing capacity."
For the nine-month period ended December 31, 2005, total revenue was
$10,026,000 compared to $6,366,000 for the same period in fiscal year 2005, an
increase of $3,660,000 or 57%. Gross profit on product revenue for the nine-
month period was $7,023,000 (73%) compared to $3,501,000 (55%) for the same
period in fiscal year 2005. Operating expenses for the nine-month period were
$10,232,000 compared to $9,978,000 for the same period in fiscal year 2005.
Net income for the nine-month period was $1,517,000 or $.05 per share compared
to a net loss of $2,557,000 or $.09 per share in the same period in fiscal
year 2005.
Update on Commercial Products, Intellectual Property and Product
Development
Protein A
* This quarter, we completed the construction of a new purification suite,
which will allow us to increase our annual manufacturing throughput in
excess of 100kg of Protein A per year. We are currently in the early
stages of building a new fermentation suite, which will decrease our
reliance on external fermentation contractors and increase our ability
to control costs.
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 which has been documented in the EU literature
to improve MRI imaging of the pancreas. Secretin is not currently
approved for this use in the U.S., which hinders wide-spread use and
reimbursement. We are currently in 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 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 are currently conducting a pilot study to assess the impact of
secretin on a surrogate marker for a cognitive deficit characteristic of
patients with schizophrenia. This study is being conducted to determine
if the preliminary finding that secretin may have had an impact on a
cognitive deficit is reproducible and related to drug treatment.
* We have evaluated 12 patients in a Phase 1 clinical study of secretin in
an anxiety disorder called Obsessive-Compulsive Disorder in which the
patients received a subcutaneous dose form of secretin three times a
week for 4 weeks. One of eight patients in the low dose group (105g/kg)
showed a clinically significant improvement that was correlated with
drug treatment; however, none of the four patients treated at a higher
dose level (205g/kg) have shown a similar response. We are currently
evaluating additional data to determine whether or not to enroll more
patients in this trial. No serious adverse events have been reported
and the drug has been well-tolerated.
Uridine
* We have received FDA approval to initiate a multi-center, placebo-
controlled, proof of principle study for a Phase 2 clinical trial of
uridine in bipolar depression. Pending IRB approval from the clinical
sites, we plan to start enrolling patients in the next 2 months. This
study is being supported in part by approximately $1,000,000 of funding
from the Stanley Medical Research Institute.
Intellectual Property
* On December 23, 2005, the FDA approved Bristol-Myers Squibb Company's
(Bristol) (NYSE: BMY) application to market CTLA4-Ig, under the brand
name Orencia(R), for treatment of rheumatoid arthritis. In January,
Repligen and The University of Michigan jointly filed a complaint
against Bristol in the U.S. District Court for the Eastern District of
Texas for infringement of U.S. Patent No. 6,685,941. The patent covers
methods of using CTLA4-Ig to treat rheumatoid arthritis, as well as
other autoimmune diseases. Repligen has exclusive rights to this patent
from the University of Michigan and the United States Navy and we intend
to seek a royalty bearing license agreement with Bristol whether through
litigation or negotiation.
* 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 arguments 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.
Quarterly Conference Call
Repligen will hold its quarterly conference call and webcast on Thursday,
February 9th at 11:00 a.m. EST. This call can be accessed either via
Repligen's website at http://www.repligen.com or you may listen to the live
broadcast by calling (888) 396-2356 for domestic calls and (617) 847-8709 for
international calls, passcode: 77214078.
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:
REPLIGEN CORPORATION
STATEMENTS OF OPERATIONS
Three months ended Nine months ended
December 31, December 31,
2005 2004 2005 2004
Revenue:
Product revenue $2,958,000 $2,260,000 $9,686,000 $6,366,000
Other revenue 30,000 - 340,000 -
Total revenue 2,988,000 2,260,000 10,026,000 6,366,000
Operating expenses:
Cost of product
revenue 817,000 1,029,000 2,663,000 2,865,000
Research and
development 1,236,000 1,039,000 3,750,000 3,703,000
Selling, general and
administrative 1,341,000 1,242,000 3,819,000 3,410,000
Total
operating
expenses 3,394,000 3,310,000 10,232,000 9,978,000
Loss from operations (406,000) (1,050,000) (206,000) (3,612,000)
Investment income 204,000 107,000 553,000 305,000
Other income - 750,000 1,170,000 750,000
Net income (loss) $(202,000) $(193,000) $1,517,000 $(2,557,000)
Earnings (loss) per
share:
Basic $(0.01) $(0.01) $0.05 $(0.09)
Diluted $(0.01) $(0.01) $0.05 $(0.09)
Weighted average shares
outstanding:
Basic 30,105,000 30,065,000 30,099,000 30,056,000
Diluted 30,105,000 30,065,000 30,667,000 30,056,000
Balance Sheet Data:
December 31, March 31,
2005 2005
Cash and investments $23,076,000 $23,523,000
Total assets 29,227,000 27,607,000
Stockholders' equity 25,860,000 24,290,000
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, Vice
President, Market Development, +1-781-419-1812 both of Repligen
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