WALTHAM, Mass., June 7 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the fourth quarter and fiscal
year 2007, ended March 31, 2007. Total revenue for fiscal year 2007 was
$14,074,000 compared to total revenue of $12,911,000 for the fiscal year
ended March 31, 2006, an increase of $1,163,000 or 9%. Total revenue for
the year consisted primarily of Protein A and SecreFlo(R) product revenue
and research revenue. Gross profit on product revenue for fiscal year 2007
was $9,459,000 (72%) compared to $8,978,000 (72%) for fiscal year 2006.
Operating expenses for the fiscal year ended March 31, 2007 were
$15,899,000 compared to $14,131,000 in fiscal year 2006. This increase in
operating expenses of $1,768,000 was primarily the result of increased
clinical trial expenses, increased personnel and stock-based compensation
expenses, which were offset by decreased external research expenses. The
Company adopted Statement of Financial Accounting Standards No. 123R as of
April 1, 2006. As a result, the Company recorded compensation expense for
stock options awarded to employees in its Statement of Operations in fiscal
year 2007. The total stock compensation expense recorded for the year ended
March 31, 2007 was $837,000.
The net loss for fiscal year 2007 was $889,000 or $.03 per share,
compared to a net profit for fiscal year 2006 of $697,000 or $.02 per
share. Cash and marketable securities as of March 31, 2007 were $22,627,000
compared to $23,408,000 as of March 31, 2006.
"Our results for fiscal year 2007 are consistent with our goal to build
a self-sustaining, integrated biopharmaceutical company," stated Walter C.
Herlihy, President and Chief Executive Officer of Repligen Corporation. "We
continue to execute on our strategy to build shareholder value through
prudent business management in which the growing profits from current
product sales enable us to develop our intellectual property and our
pipeline of drug candidates without many of the financial risks typically
associated with an emerging biotech company."
Total revenue for the fourth quarter of fiscal year 2007 was $3,699,000
compared to $2,885,000 for the same period in fiscal year 2006, an increase
of 28%. Gross profit on product revenue for the fourth quarter of fiscal
year 2007 was $2,495,000 (73%) compared to $1,955,000 (69%) for the fourth
quarter of fiscal year 2006. Operating expenses for the fourth quarter of
fiscal year 2007 were $4,050,000 compared to $3,899,000, for the fourth
quarter of fiscal year 2006. The net loss for the fourth quarter of fiscal
year 2007 was $107,000 or $.00 per share, compared to a net loss of
$820,000 or $.03 per share for the fourth quarter of fiscal year 2006.
Corporate Update
Secretin for Imaging of the Pancreas
In May, we reported positive results from a Phase 2 clinical trial to
evaluate the use of RG1068, synthetic human secretin, as an agent to
improve the assessment of pancreatic duct structures by magnetic resonance
imaging (MRI). The study showed an improvement in sensitivity of detection
of structural abnormalities of the pancreatic duct of approximately 20%
with no loss in specificity, consistent with prior data and expectations.
In addition, the study showed highly significant increases in the following
three assessments: physician confidence in their ability to identify
structural abnormalities, the number of pancreatic duct segments visualized
and improvement in the overall quality of the MRI images. Detailed visual
assessment of the pancreatic ducts and identification of structural
abnormalities is important in the assessment, diagnosis and treatment of
diseases such as acute and chronic pancreatitis.
Uridine for Bipolar Depression
We are currently conducting a Phase 2 clinical trial of RG2417, an oral
formulation of uridine, in bipolar depression. This is a multi-center study
in which approximately 80 patients will receive an oral formulation of
uridine or a placebo for 6 weeks. We have completed enrollment in this
study and we expect to have results in the fall.
Transcription Activators for Friedreich's Ataxia
In April, we entered into an exclusive commercial license with The
Scripps Research Institute for intellectual property covering compounds,
which may have utility in treating Friedreich's ataxia. Friedreich's ataxia
is an inherited neurodegenerative disease in which low levels of the
protein frataxin result in progressive damage to the nervous system and
loss of muscle function. Research in tissues derived from patients as well
as in mice indicates that the licensed compounds increase production of the
protein frataxin, which suggests potential utility of these compounds in
slowing or stopping progression of the disease. There is currently no
treatment for Friedreich's ataxia.
Commercial Products
In June, we announced that we have expanded our longstanding
relationship with Applied Biosystems by entering into a four year supply
agreement for recombinant Protein A. Repligen is the world's leading
supplier of recombinant Protein A, a consumable used in the manufacture of
monoclonal antibodies, the largest and fastest growing class of drug in the
biopharmaceutical industry.
Quarterly Conference Call
Walter C. Herlihy, Ph.D., will host a conference call and webcast on
Thursday, June 7th at 11:00 a.m. EDT, to review fourth quarter and fiscal
year 2007 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 listen to the live broadcast by calling (866) 831-6234
for domestic calls and (617) 213-8854 for international calls. Participants
must provide the following passcode: 86421181.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the
development of novel therapeutics for diseases that affect the central
nervous system. 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
Operating Statement Data:
Three months ended Years ended
March 31, March 31,
2007 2006 2007 2006
Revenue:
Product revenue $3,397,000 $2,843,000 $13,074,000 $12,529,000
Other revenue 302,000 42,000 1,000,000 382,000
Total revenue 3,699,000 2,885,000 14,074,000 12,911,000
Operating expenses:
Cost of product
revenue 902,000 888,000 3,615,000 3,551,000
Research and
development 1,452,000 1,413,000 5,924,000 5,163,000
Selling, general
and administrative 1,696,000 1,598,000 6,360,000 5,417,000
Total operating
expenses 4,050,000 3,899,000 15,899,000 14,131,000
Loss from operations (351,000) (1,014,000) (1,825,000) (1,220,000)
Interest expense (3,000) (3,000) (11,000) (3,000)
Investment income 247,000 197,000 947,000 750,000
Other income - - - 1,170,000
Net income (loss) $(107,000) $(820,000) $(889,000) $697,000
Earnings Per Share:
Basic and diluted $- $(0.03) $(0.03) $0.02
Weighted average shares
outstanding:
Basic 30,420,000 30,202,000 30,379,000 30,125,000
Diluted 30,420,000 30,202,000 30,379,000 30,691,000
As of March 31,
(In thousands)
Balance Sheet Data: 2007 2006
Cash and marketable
securities* $22,627 $23,408
Working capital 22,394 18,575
Total assets 29,076 28,599
Long-term obligations 200 231
Accumulated deficit (157,683) (156,794)
Stockholders' equity 25,538 25,433
*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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