WALTHAM, Mass., Feb. 7 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the third quarter of fiscal year
2008, ended December 31, 2007. Total revenue for the quarter was $4,664,000
compared to $3,882,000 for the third quarter of fiscal year 2007 ended
December 31, 2006, an increase of $782,000 or 20.1%. Total revenue for the
quarter consisted primarily of Protein A product revenue. Gross profit on
product revenue for the third quarter of fiscal year 2008 was $2,832,000
(62.1%) compared to $2,828,000 (77.8%) for the same period in fiscal year
2007. The change in gross profit margin is primarily due to a change in
product mix and expenses associated with quality systems.
Operating expenses were $5,663,000 for the third quarter of fiscal year
2008 compared to $4,139,000 for the same period in fiscal year 2007. This
increase in operating expenses of $1,524,000 was primarily the result of
litigation expenses incurred in conjunction with our ongoing patent
infringement lawsuit against Bristol-Myers Squibb and direct material
expenses, which were partially offset by lower clinical operations costs.
Net loss for the third quarter of fiscal year 2008 was $241,000 or
$0.01 per diluted share, compared to a net loss for the third quarter of
fiscal year 2007 of $20,000 or $0.00 per diluted share. Cash, cash
equivalents and marketable securities as of December 31, 2007 were
$61,343,000 compared to $22,627,000 as of March 31, 2007.
"We are very pleased to have advanced our product pipeline and achieved
continued strong product sales during the quarter," stated Walter C.
Herlihy, President and Chief Executive Officer of Repligen Corporation.
"Our financial stability and cash reserves will allow us to continue to
invest in the development of our pipeline candidates, aggressively defend
our CTLA4 intellectual property and be opportunistic in the acquisition of
new product candidates for our pipeline."
For the nine-month period ended December 31, 2007, total revenue was
$15,994,000 compared to $10,375,000 for the same period in fiscal year
2007. Gross profit on product revenue for the nine-month period ended
December 31, 2007 was $10,593,000 (68.6%) compared to $6,964,000 (72%) for
the same period in fiscal year 2007. The Company recorded a net gain of
$40,170,000 from litigation settlement with ImClone during the second
quarter of fiscal 2008. Operating expenses, exclusive of the net gain from
litigation settlement, were $16,409,000 for the nine-month period ended
December 31, 2007 compared to $11,849,000 for the same period in fiscal
year 2007. Net income for the nine- month period ended December 31, 2007
was $40,304,000 or $1.29 per diluted share compared to a net loss of
$782,000 or $0.03 per share in the same period in fiscal year 2007.
Corporate Update
Secretin (RG1068) for Imaging of the Pancreas
We have previously met with the FDA to discuss the results of our Phase
2 clinical study of RG1068, synthetic human secretin, for MRI imaging of
the pancreas and we believe that a single positive Phase 3 clinical trial
of similar design to the Phase 2 study will be sufficient for an NDA
filing. We have finalized the Phase 3 protocol and we plan to initiate the
study later this quarter. We believe there may be more than 150,000
pancreatic MRI imaging procedures conducted in the U.S. each year that
could benefit from the use of secretin.
Uridine (RG2417) for Bipolar Disorder
In November, we reported positive results from our Phase 2a clinical
trial of RG2417, an oral formulation of uridine, in bipolar disorder. This
was a multi-center study in which 83 patients received RG2417 or a placebo
over a 6- week period. Over the six-week treatment period, the study
demonstrated a statistically significant improvement in the symptoms of
depression in the patients receiving RG2417 when compared to placebo on the
Montgomery Asberg Depression Rating Scale (MADRS) (p=0.03) and a strong
trend toward improvement on the Clinical Global Impression of Change in
Bipolar Disorder Scale (CGI-BP- C) (p=0.06). In addition, RG2417 did not
appear to induce mania, a side affect that has been associated with the use
of a class of antidepressants known as SSRI's in this patient population.
This quarter, we plan to submit a detailed report of the results of this
study to the FDA along with a proposal to initiate a larger Phase 2b
clinical trial of RG2417 in patients with bipolar disorder.
HDAC Inhibitors for Friedreich's Ataxia
We own the rights from The Scripps Research Institute to intellectual
property covering compounds which may have utility in treating Friedreich's
ataxia. We have synthesized and evaluated more than 100 second-generation
compounds and have identified several with improved specificity and
toxicity profiles. We are currently assessing the detailed pharmacology and
toxicology profiles of active lead compounds to identify an appropriate
candidate for the clinic. In addition, we are continuing to evaluate this
family of compounds for activity in animal models of Friedreich's ataxia
and other neurodegenerative diseases such as Huntington's disease and
spinal muscular atrophy.
Intellectual Property
CTLA4-Ig Patent
Repligen and The University of Michigan previously filed a lawsuit
against Bristol-Myers Squibb (Bristol) for infringement of U.S. Patent No.
6,685,941 that covers a method of treating rheumatoid arthritis with
CTLA4-Ig. Bristol markets CTLA4-Ig for treatment of rheumatoid arthritis,
under the brand name Orencia(R). Repligen has exclusive rights to this
patent from its owners, the University of Michigan and the United States
Navy. We anticipate that Summary Judgment briefing in this case will be
completed in February and a trial will occur in the United States District
Court for the Eastern District of Texas in April.
Quarterly Conference Call
Walter C. Herlihy, Ph.D., will host a conference call and webcast on
Thursday, February 7th at 11:00 a.m. EST, to review third quarter fiscal
year 2008 financial results and expectations and provide a quarterly update
of the Company. This call is being webcast and can be accessed via
Repligen's website at http://www.repligen.com or you may also listen to the
live broadcast by calling (888) 713-4216 for domestic calls and (617)
213-4868 for international calls. Participants must provide the following
passcode: 98169734. 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 focused on the
development of novel therapeutics for neurological disorders. In addition,
we are the world's leading supplier of recombinant Protein A, the sales of
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 (Unaudited)
Operating Statement Data:
Three months ended Nine months ended
December 31, December 31,
2007 2006 2007 2006
Revenue:
Product revenue $4,563,000 $3,633,000 $15,450,000 $9,677,000
Other revenue 101,000 249,000 544,000 698,000
Total revenue 4,664,000 3,882,000 15,994,000 10,375,000
Operating expenses:
Cost of product revenue 1,731,000 805,000 4,857,000 2,713,000
Research and development 1,591,000 1,674,000 4,883,000 4,472,000
Selling, general and
administrative 2,341,000 1,660,000 6,669,000 4,664,000
Net gain from litigation
settlement - - (40,170,000) -
Total operating
expenses 5,663,000 4,139,000 (23,761,000) 11,849,000
Income (loss) from
operations (999,000) (257,000) 39,755,000 (1,474,000)
Investment income 760,000 240,000 1,383,000 701,000
Interest expense (2,000) (3,000) (7,000) (9,000)
Income (loss) before
taxes (241,000) (20,000) 41,131,000 (782,000)
Income tax provision - - (827,000) -
Net income (loss) $(241,000) $(20,000) $40,304,000 $(782,000)
Earnings (loss) per
share:
Basic $(0.01) $- $1.31 $(0.03)
Diluted $(0.01) $- $1.29 $(0.03)
Weighted average shares
outstanding:
Basic 30,954,000 30,376,000 30,763,000 30,366,000
Diluted 30,954,000 30,376,000 31,238,000 30,366,000
December 31, March 31,
2007 2007
Balance Sheet Data:
Cash, cash equivalents
and marketable
securities * $61,343,000 $22,627,000
Total assets 70,459,000 29,076,000
Total stockholders'
equity 67,123,000 25,538,000
* 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, VP,
Market Development, +1-781-419-1812, both of Repligen Corporation
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