WALTHAM, Mass., Aug. 7 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the first quarter of fiscal year
2009, ended June 30, 2008. Total revenue for the quarter was $13,660,000
compared to total revenue of $5,979,000 for the first quarter of fiscal
year 2008 ended June 30, 2007, an increase of $7,681,000 or 128%. Total
revenue was comprised of product revenue and royalty and other revenue.
Product revenue for the first quarter of fiscal year 2009 was $5,693,000
and was comprised primarily of Protein A product revenue. Royalty and other
revenue for the first quarter of fiscal year 2009 was $7,966,000 and was
comprised primarily of royalty payments from Bristol-Myers Squibb Company
on the U.S. sales of Orencia(R) related to the April patent licensing
agreement, and includes $6,330,000 of royalties from February 2006 to March
31, 2008 as well as $1,566,000 of royalties for the first quarter of fiscal
year 2009.
Operating expenses for the first quarter of fiscal year 2008 were
$5,702,000 compared to $5,994,000 for the same time period in fiscal year
2007. This decrease in operating expenses of $292,000 was primarily the
result of decreased litigation expenses and in-licensing expenses partially
offset by increased external research, clinical and direct material
expenses.
The net income for the first quarter of fiscal year 2009 was $8,279,000
or $.26 per diluted share, compared to net income for the first quarter of
fiscal year 2008 of $240,000 or $.01 per diluted share. Cash, cash
equivalents and marketable securities as of June 30, 2008 were $66,126,000
compared to $60,589,000 as of March 31, 2008.
"We are very pleased that the licensing of our CTLA4-Ig patent to
Bristol and our Protein A business continue to provide a growing stream of
revenue and profits for Repligen," stated Walter C. Herlihy, President and
Chief Executive Officer of Repligen Corporation. "Our financial strength
will allow us to expand our pipeline, advance our candidates through
proof-of-principle clinical trials, complete our late stage clinical
development programs, and capture value through partnering or our own
commercial efforts."
Corporate Update
Secretin (RG1068) for Imaging of the Pancreas
We are currently enrolling patients in our Phase 3 clinical trial of
RG1068, synthetic human secretin, to improve the assessment of pancreatic
duct structures by magnetic resonance imaging (MRI). This 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. This study is being conducted at approximately 30
clinical sites within the United States and Canada and will enroll
approximately 250 patients. This program has been granted Fast Track
Designation by the FDA, a process designed to facilitate the development
and expedite the review of drugs that treat serious diseases and fill an
unmet medical need. There are more than 150,000 procedures conducted in the
United States each year that could benefit from enhancement with RG1068.
Uridine (RG2417) for Bipolar Disorder
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 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 will be designed to assess the efficacy and
safety of RG2417 on the symptom of depression as measured by the
Montgomery-Asberg Depression Rating Scale (MADRS).
This study is based on the results of a positive Phase 2a study in
which 83 patients received either RG2417 or a placebo twice a day for
six-weeks. 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 MADRS (p=0.01)
and the Clinical Global Impression of Change (p=.04).
HDAC Inhibitors for Friedreich's Ataxia
We are currently developing compounds which may have utility in
treating Friedreich's ataxia. Friedreich's ataxia is a progressive,
inherited neurodegenerative disease which leads to incapacitation or loss
of life in early adulthood. We have identified advanced leads through
multiple rounds of novel compound library synthesis and screening for
potency, specificity, metabolism and pharmacology. These advanced leads are
being further characterized in animal models for their pharmacologic,
toxicologic and pharmacodynamic profiles to identify an appropriate
candidate for the clinic. There is currently no treatment approved by the
FDA for treatment of Friedreich's ataxia.
Protein A Business
In July, we were the first company in North America to receive
certification to BS25999, the new standard for business continuity
management. Business continuity management systems are designed to build
resiliency within an organization and to ensure continued operations in the
event of a business disruption, whether due to a major disaster or a minor
incident. Repligen developed and implemented a business continuity
management system to ensure an uninterrupted supply of its recombinant
Protein A products, a key consumable used by the biopharmaceutical industry
to manufacture drugs called monoclonal antibodies. Certification of
Repligen's business continuity management system to BS25999 demonstrates
that our program meets globally accepted best practices for business
continuity.
CTLA4-Ig Patent
In April, we reached a settlement with Bristol-Myers Squibb Company 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, August 7th at 11:00 a.m. EDT, to review first quarter fiscal year
2009 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 (866) 761-0748 for domestic calls and (617) 614-2706 for
international calls. Participants must provide the following passcode:
62772305. 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
SELECTED FINANCIAL DATA
Unaudited
Three months ended June 30,
2008 2007
Revenue:
Product revenue $5,693,343 $5,731,476
Royalty and other revenue 7,966,902 247,342
Total revenue 13,660,245 5,978,818
Operating expenses:
Cost of product revenue 1,846,401 1,714,299
Cost of royalty and other revenue 325,000 -
Research and development 2,084,125 2,137,326
Selling, general and administrative 1,446,571 2,142,131
Total operating expenses 5,702,097 5,993,756
Income (loss) from operations 7,958,148 (14,938)
Investment income 532,585 257,367
Interest expense (1,905) (2,451)
Income before income taxes 8,488,828 239,978
Provision for income taxes 210,000 -
Net income $8,278,828 $239,978
Earnings per share:
Basic $0.27 $0.01
Diluted $0.26 $0.01
Weighted average shares outstanding:
Basic 31,152,566 30,564,494
Diluted 31,585,112 31,127,099
Balance Sheet Data: As of June 30, As of March 31,
2008 2008
Cash, cash equivalents, and
marketable securities* $66,126,165 $60,589,054
Working capital 51,476,498 49,831,378
Total assets 75,609,331 68,839,707
Long-term obligations 136,735 143,043
Accumulated deficit (112,297,992) (120,576,819)
Stockholders' equity 72,780,569 64,106,855
*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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