WALTHAM, Mass., June 12 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the fourth quarter and fiscal
year 2008, ended March 31, 2008. Total revenue for fiscal year 2008 was
$19,296,000 compared to total revenue of $14,074,000 for fiscal year 2007
ended March 31, 2007, an increase of $5,222,000 or 37%. Total revenue for
the year consisted primarily of Protein A and SecreFlo(R) product revenue.
Operating expenses for fiscal year 2008, excluding the $40,170,000 net
gain from litigation previously reported in our second quarter as a result
of our settlement with ImClone Systems, Inc., were $23,574,000 compared to
$15,900,000 in fiscal year 2007. The increase in operating expenses of
$7,674,000 was primarily the result of legal expenses incurred in
conjunction with both the ImClone Systems, Inc. and Bristol-Myers Squibb
litigations, direct material expenses associated with the increase in
revenue, and increased research and development spending.
Net income for the year was $37,107,000 or $1.18 per diluted share,
compared to a net loss for fiscal 2007 of $889,000 or $0.03 per diluted
share. Net income includes a net gain of $40,170,000 from the litigation
settlement with ImClone during the second quarter of fiscal year 2008. Cash
and marketable securities as of March 31, 2008 were $60,589,000 compared to
$22,627,000 as of March 31, 2007.
"During the past year, we have successfully advanced our product
pipeline, achieved strong revenue growth and settled our outstanding
litigations with ImClone Systems, Inc. and Bristol-Myers Squibb, resulting
in substantial new resources for the company," stated Walter C. Herlihy,
President and Chief Executive Officer of Repligen Corporation. "Our
financial resources will allow us to continue to execute on our strategy to
acquire rights to patented, development stage drug candidates, advance the
candidates through proof-of-principle clinical trials and generate value
through partnering or our own commercial efforts."
Total revenue for the fourth quarter of fiscal year 2008 was $3,301,000
compared to $3,699,000 for the same period in fiscal year 2007, a decrease
of 11%. Operating expenses for the fourth quarter of fiscal year 2008 were
$7,165,000 compared to $4,050,000. Net loss for the fourth quarter of
fiscal year 2008 was $3,198,000 or $0.10 per diluted share, compared to a
net loss for the fourth quarter of fiscal year 2007 of $107,000 or $0.00
per diluted share.
Corporate Update
Secretin (RG1068) for Imaging of the Pancreas
In March, we initiated a Phase 3 clinical trial to evaluate the use of
RG1068, synthetic human secretin, to improve the assessment of pancreatic
duct structures by magnetic resonance imaging (MRI). The Phase 3 study is a
multi-center, baseline-controlled, single dose study in which approximately
250 patients will receive an unenhanced MRI followed by a secretin-enhanced
MRI of the pancreas. The study is designed to assess the sensitivity and
specificity of secretin-enhanced MRI to improve the ability to detect
pancreatic duct abnormalities relative to MRI alone. Detailed visual
assessment of the pancreatic ducts is important in the assessment,
diagnosis and treatment of diseases such as acute and chronic pancreatitis.
The study is being conducted at approximately 30 clinical sites within the
United States and Canada. In April, the U.S. Food and Drug Administration
granted Fast Track Designation to our development program. Fast Track is a
process designed to facilitate the development and expedite the review of
drugs that treat serious diseases and fill an unmet medical need.
Uridine (RG2417) for Bipolar Disorder
Today, we announced that based on feedback from the Food and Drug
Administration (FDA) we plan to initiate a Phase 2b clinical trial of
RG2417, an oral formulation of uridine in patients with bipolar disorder in
the fall. This will be a multi-center, parallel arm placebo-controlled,
clinical trial in which approximately 150 patients with bipolar disorder
will receive either RG2417 or a placebo twice a day for eight-weeks. This
study is designed to assess the efficacy and safety of RG2417 on the
symptom of depression as measured by the Montgomery-Asberg Depression
Rating Scale (MADRS). Gary S. Sachs, M.D., founder and director of the
Bipolar Clinic and Research Program at the Massachusetts General Hospital
and an Associate Professor of Psychiatry at the Harvard Medical School will
be the Principal Investigator of this study.
In addition, we announced today that we have completed our assessment
of the data from the previous Phase 2a study and have found that patients
with a history of more frequent symptoms demonstrated greater improvements
when treated with RG2417 than patients without a history of frequent
symptoms. For example, patients with more than 5 episodes of depression
over their entire life (n=50) demonstrated greater improvements in their
symptoms of depression compared to patients with 5 or fewer lifetime
episodes of depression. From weeks 2-6 of treatment, the patients with more
than 5 lifetime episodes of depression who received RG2417 had an average
improvement on MADRS of 5.5 points over placebo (p<0.001), compared to all
patients in the study receiving RG2417 who had an average improvement on
MADRS of 3.0 points over placebo (p=0.01) as previously reported. This
result may reflect the difficulty in accurately diagnosing bipolar disorder
in the absence of frequent symptomatology and will be used in the design
and execution of the next study.
HDAC Inhibitors for Friedreich's Ataxia
We are currently developing compounds which may have utility in
treating Friedreich's ataxia. Over the past year, we made significant
progress in identifying advanced leads through multiple rounds of novel
compound library synthesis and screening for potency, specificity,
metabolism and pharmacology. Over the next year these advanced leads will
be further characterized in animal models for their pharmacologic,
toxicologic and pharmacodynamic profiles to identify an appropriate
candidate for the clinic. We have also received a grant from Go FAR to
develop a biomarker tool which may be useful in monitoring the biochemical
activity and guiding the dosing frequency of a clinical candidate in
patients. Go FAR (Friedreich's Ataxia Research) is a fundraising
organization headquartered in Turin, Italy formed by the non-profit group
RUDI Onlus Committee, dedicated to raising donations to fund research and
development of treatments for Friedreich's ataxia.
Intellectual Property
CTLA4-Ig Patent
In April, we reached a settlement with Bristol-Myers Squibb Company
(Bristol) in our lawsuit alleging infringement of U.S. Patent No.
6,685,941, based on Bristol's sale of Orencia(R) for the treatment of
rheumatoid arthritis. The settlement provided for Bristol to make an
initial payment of $5,000,000 and to pay royalties on the U.S. net sales of
Orencia(R) for any clinical indication at a rate of 1.8% for the first
$500,000,000 of annual net sales, 2.0% for the next $500,000,000 of annual
net sales and 4% of annual net sales in excess of $1 billion for each year
until December 31, 2013. Based on analysts' estimates for the future U.S.
sales of Orencia(R), we anticipate cash receipts in excess of $100 million
over the term of the license.
Quarterly Conference Call
Walter C. Herlihy, Ph.D., will host a conference call and webcast on
Thursday, June 12th at 11:00 a.m. EDT, to review fourth quarter and fiscal
year 2008 financial results and expectations and provide a quarterly update
of the Company. Dr. Herlihy will be joined on the call by Dr. Gary Sachs,
the founder and director of the Bipolar Clinic and Research Program at
Massachusetts General Hospital and an Associate Professor of Psychiatry at
the Harvard Medical School to discuss Repligen's RG2417 program for bipolar
disorder. 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 (800) 261-3417 for domestic calls and (617) 614-3673
for international calls. Participants must provide the following passcode:
34058699. 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.
REPLIGEN CORPORATION
STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended Year ended
March 31, March 31,
2008 2007 2008 2007
Revenue:
Product revenue $3,136,577 $3,396,737 $18,587,376 $13,073,894
Other revenue 164,200 302,075 708,905 1,000,345
Total revenue 3,300,777 3,698,812 19,296,281 14,074,239
Operating expenses:
Cost of product
revenue 1,303,054 901,952 6,160,245 3,614,837
Research and
development 2,357,696 1,452,215 7,240,812 5,924,439
Selling,
general and
administrative 3,504,362 1,695,945 10,173,400 6,360,292
Net gain from
litigation
settlement - - (40,170,000) -
Total operating
expenses 7,165,112 4,050,112 (16,595,543) 15,899,568
Income (loss) from
operations (3,864,335) (351,300) 35,891,824 (1,825,329)
Investment income 668,480 246,782 2,051,258 947,547
Interest expense (1,744) (2,451) (9,097) (11,481)
Income (loss) before
income taxes (3,197,599) (106,969) 37,933,985 (889,263)
Provision for
income taxes - - (827,471) -
Net income (loss) $(3,197,599) $(106,969) $37,106,514 $(889,263)
Earnings (loss)
per share:
Basic $(0.10) $- $1.20 $(0.03)
Diluted $(0.10) $- $1.18 $(0.03)
Weighted average
shares outstanding:
Basic 31,064,483 30,419,879 30,834,491 30,379,350
Diluted 31,064,483 30,419,879 31,320,997 30,379,350
As of March 31,
(In thousands)
Unaudited
Balance Sheet Data: 2008 2007
Cash and marketable securities* $60,589 $22,627
Working capital 49,831 22,394
Total assets 68,840 29,076
Long-term obligations 143 200
Accumulated deficit (120,577) (157,683)
Stockholders' equity 64,107 25,538
*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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