Company Reports 110% Increase in Total Product Revenue
WALTHAM, Mass., Nov. 3 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the second quarter of fiscal year
2006 ended September 30, 2005. Total revenue for the quarter was $2,800,000
compared to total revenue of $1,296,000 for the second quarter of fiscal year
2005. Product revenue for the second quarter was $2,716,000 compared to
product revenue of $1,296,000 for the second quarter of fiscal year 2005, an
increase of 110%. Gross profit for the second quarter of fiscal year 2006 was
$1,844,000 (68%), compared to $593,000 (46%) for the same period in fiscal
year 2005. This increase in product revenue and profit margin was primarily
due to increased customer demand, change in product mix and decreased royalty
obligation for SecreFlo(R).
Operating expenses for the second quarter of fiscal year 2006 ended
September 30, 2005 were $3,480,000 compared to $3,116,000 for the second
quarter of fiscal year 2005. The net loss for the second quarter of fiscal
year 2006 was $468,000 or $.02 per share, compared to a net loss of
$1,719,000 or $.06 per share for the second quarter of fiscal year 2005. Cash
and investments as of September 30, 2005 were $24,875,000 compared to
$23,841,000 on March 31, 2005.
For the six-month period ended September 30, 2005, total revenue was
$7,038,000 compared to $4,106,000 for the same period in fiscal year 2005, an
increase of $2,932,000 or 71%. Gross profit for the six-month period was
$4,882,000 (73%) compared to $2,270,000 (55%) for the same period in fiscal
year 2005. Operating expenses for the six-month period were $6,838,000
compared to $6,668,000 for the same period in fiscal year 2005. Net profit
for the six-month period was $1,719,000 or $.06 per share compared to a net
loss of $2,364,000 or $.08 per share in the same period in fiscal year 2005.
In the first quarter of fiscal year 2006, the Company recorded as other income
$1,170,000 of a previously expensed but disputed royalty obligation that was
reversed as a result of the SecreFlo(R) settlement in May 2005.
"The continued growth of the monoclonal antibody market and strong demand
for our Protein A products, has resulted in increased product sales and gross
profit," stated Walter C. Herlihy, President and Chief Executive Officer of
Repligen Corporation. "We continue to advance the development of our
proprietary clinical products while preserving financial stability."
Update on Product Development Programs
Secretin
-- In October we announced the initiation of a follow-on 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 are currently conducting a Phase 1 clinical study of secretin in an
anxiety disorder called obsessive-compulsive disorder in which the
patients receive a subcutaneous dose of secretin three times a week.
We expect to complete patient enrollment by the end of the year and to
report results of the study in the first quarter of 2006.
Uridine
-- In October we announced that we have entered an expanded agreement with
the Stanley Medical Research Institute under which Repligen will
receive approximately $1,000,000 of funding for a Phase 2 clinical
trial of uridine in bipolar depression. Pending approval by the FDA,
we plan to initiate a multi-center, placebo-controlled, proof of
principle study in the first quarter of 2006.
Intellectual Property
-- As previously disclosed, Repligen and MIT filed suit against ImClone,
alleging that ImClone has infringed U.S. Patent No. 4,663,281 in its
production of Erbitux(R). Our patent infringement lawsuit is
progressing steadily; the discovery phase of the case is nearly
complete and the deadline for summary judgment motions is November
30th. Unless there is a settlement or a summary judgment, we expect
this case will come to trial in 2006.
-- Bristol-Myers Squibb Corporation announced in September that the FDA
Arthritis Advisory Committee unanimously (7-0) recommended approval of
Orencia(R) (CTLA4-Ig), for the treatment of rheumatoid arthritis. The
FDA has informed Bristol that it will complete the review of the
CTLA4-Ig filing by the end of this year. Bristol stated last week that
pending FDA approval, they are evaluating a range of options for the
launch of Orencia(R) in early 2006. We own the rights to a United
States patent for the use of CTLA4-Ig for the treatment of various
autoimmune diseases, including rheumatoid arthritis, which will remain
in force until 2021.
Quarterly Conference Call
Repligen's President and Chief Executive Officer, Walter C. Herlihy,
Ph.D., will host a conference call and webcast on Thursday, November 3rd at
11:00 a.m. EST, to report second quarter fiscal year 2006 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) 831-6224 for domestic calls and (617) 213-8853 for
international calls, passcode: 20784622. 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 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 Six months ended
September 30, September 30,
2005 2004 2005 2004
Revenue:
Product revenue $2,716,000 $1,296,000 $6,728,000 $4,106,000
Research revenue 84,000 - 310,000 -
Total revenue 2,800,000 1,296,000 7,038,000 4,106,000
Operating expenses:
Cost of product
revenue 872,000 703,000 1,846,000 1,836,000
Research and
development 1,325,000 1,274,000 2,514,000 2,663,000
Selling, general
and administrative 1,283,000 1,139,000 2,478,000 2,169,000
Total
operating
expenses 3,480,000 3,116,000 6,838,000 6,668,000
Income (loss) from
operations (680,000) (1,820,000) 200,000 (2,562,000)
Investment income 212,000 101,000 349,000 198,000
Other income - - 1,170,000 -
Net income (loss) $(468,000) $(1,719,000) $1,719,000 $(2,364,000)
Earnings Per Share:
Basic $(0.02) $(0.06) $0.06 $(0.08)
Diluted $(0.02) $(0.06) $0.06 $(0.08)
Weighted average shares
outstanding:
Basic 30,098,000 30,058,000 30,096,000 30,051,000
Diluted 30,098,000 30,058,000 30,607,000 30,051,000
Balance Sheet Data:
September 30, March 31,
2005 2005
Cash and investments $24,875,000 $23,841,000
Total assets 29,090,000 27,607,000
Stockholders' equity 26,038,000 24,290,000
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 and product development and
manufacturing plans and performance such as the anticipated growth in the
monoclonal antibody market 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, +1-781-250-0111, ext. 2000, or Laura
Whitehouse, Vice President, Market Development, +1-781-250-0111,
ext. 2306 both of Repligen
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