Repligen Reports Second Quarter Fiscal Year 2010 Financial Results

WALTHAM, Mass., Nov. 5 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq:
RGEN) today reported results for the second quarter of fiscal year 2010, ended
September 30, 2009. Total revenue for the quarter was $5,421,000 compared to
total revenue of $5,090,000 for the second quarter of fiscal year 2009 ended
September 30, 2008. Total revenue for the second quarter of fiscal year 2010
was comprised of Protein A product revenue of $2,742,000 and royalty and
research revenue of $2,679,000, consisting primarily of royalty payments from
Bristol-Myers Squibb on the U.S. sales of Orencia(®).

Operating expenses for the second quarter of fiscal year 2010 were $6,627,000
compared to $5,414,000 for the same time period in fiscal year 2009. This
increase in operating expenses of $1,213,000 was primarily the result of
increased spending associated with our Phase 3 clinical trial of RG1068 for
pancreatic imaging, our Phase 2b clinical trial of RG2417 for bipolar
depression, and increased research and development costs associated with our
efforts to identify a clinical candidate for Friedreich's ataxia. Selling,
general and administrative expenses have also increased $359,000 due to
expanded business development activities compared to the prior year.

Net loss for the second quarter of fiscal year 2010 was $980,000 or $0.03 per
diluted share, compared to a net gain for the second quarter of fiscal year
2009 of $142,000 or $0.00 per diluted share. Cash, cash equivalents and
marketable securities as of September 30, 2009 were $60,224,000 compared to
$63,961,000 as of March 31, 2009.

"This quarter we have made significant progress on achieving both the clinical
development and business development objectives we established for this year,"
stated Walter C. Herlihy, President and Chief Executive Officer of Repligen
Corporation. "We are on track to announce the results of our Phase 3 clinical
trial of RG1068 in MRI imaging of the pancreas before the end of the year."

For the six-month period ended September 30, 2009, total revenue was
$10,481,000 compared to $18,750,000 for the same period in fiscal year 2009.
The prior year results were favorably impacted by a one-time payment of
$6,330,000 by Bristol Myers Squibb Company for royalties on the U.S. sales of
Orencia(®) prior to the April 2008 patent licensing agreement. Operating
expenses for the six-month period ended September 30, 2009 were $13,116,000
compared to $11,117,000 for the same period in fiscal year 2009. Net loss for
the six-month period ended September 30, 2009 was $2,086,000 or $0.07 per
diluted share compared to a net gain of $8,421,000 or $0.27 per diluted share
for the same period in fiscal year 2009.

Corporate Update

RG1068 for Imaging of the Pancreas
In October, we completed patient treatment in our Phase 3 clinical trial of
RG1068, synthetic human secretin, in magnetic resonance imaging (MRI) of the
pancreas. The study is designed to assess the sensitivity and specificity of
RG1068 in conjunction with MRI for the detection of pancreatic duct
abnormalities compared to MRI alone. Additional assessments include safety,
physician confidence in the identification of structural abnormalities, the
number of pancreatic duct segments visualized and the improvement in the
quality of the MRI images. The study enrolled 258 patients at 23 clinical
sites within the United States and Canada, and we expect to release top-line
results for the study later this year. Detailed visual assessment of the
pancreatic ducts is important in the diagnosis and treatment of diseases such
as acute and chronic pancreatitis. The FDA has granted this program Fast
Track Designation, 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 currently more than 300,000 MRI procedures conducted
in the U.S. and Europe each year that could benefit from the use of RG1068.

RG2417 for Bipolar Disorder
We are currently enrolling a Phase 2b clinical trial of RG2417, an oral
formulation of uridine, in patients with bipolar depression. This is a
multi-center, randomized, double-blind, placebo-controlled clinical trial in
which approximately 150 patients with bipolar depression will receive either
RG2417 or a placebo twice a day for eight weeks. The study is designed to
assess the safety and efficacy of RG2417 on the symptoms of depression as
measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and the
Clinical Global Impression of Change in Bipolar Disorder scale (CGI-BP-C).
There are more than five million adults worldwide with bipolar disorder.

HDAC Inhibitors for Friedreich's Ataxia
We are currently developing inhibitors of histone deacetylase enzymes (HDACs)
for the treatment of inherited neurodegenerative diseases such as Friedreich's
ataxia. Preclinical studies have shown that specific HDAC inhibitors increase
production of the protein frataxin which may have the potential to arrest
disease progression in patients with Friedreich's ataxia. We have identified
a potential clinical candidate which is being characterized in preclinical
models to fully assess its pharmacologic, toxicologic and pharmacodynamic
profile. In September we reported publication of research that identifies
histone deacetylase 3 (HDAC 3) as an important enzyme target for therapeutic
intervention in Friedreich's ataxia. These research findings confirm the drug
target of the HDAC inhibitors that we are currently developing for the
treatment of Friedreich's ataxia. The study, entitled "Chemical Probes
Identify a Role for Histone Deacetylase 3 in Friedreich's Ataxia Gene
Silencing" published in the journal Chemistry & Biology (volume 16, 980-989,
September 25, 2009) was conducted in collaboration with scientists at The
Scripps Research Institute.

Promoter of Gene Expression for Spinal Muscular Atrophy
In October, we entered into an exclusive license agreement with Families of
Spinal Muscular Atrophy (FSMA) for intellectual property covering compounds
which may have utility in treating Spinal Muscular Atrophy (SMA). SMA is an
inherited neurodegenerative disease in which a defect in the SMN1 ("survival
motor neuron") gene results in low levels of the protein SMN and leads to
progressive damage to motor neurons, loss of muscle function and, in many
patients, early death. The licensed compounds increase the production of SMN
in cells derived from patients. Further testing of these compounds in two
transgenic mouse models of SMA demonstrated significantly increased survival
suggesting potential clinical utility. SMA is diagnosed in approximately one
in every 6,000 births in the United States and Europe where the estimated
prevalence is approximately 20,000 patients. There is currently no treatment
or cure for SMA.

Quarterly Conference Call
Repligen will host a conference call and webcast on Thursday, November 5th at
10:00 a.m. EST, to review financial results. This call can be accessed via
Repligen's website at www.repligen.com or by calling (866) 804-6924 for
domestic calls and (857) 350-1670 for international calls. Participants must
provide the following passcode: 79134378.

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 www.repligen.com.

REPLIGEN CORPORATION
STATEMENTS OF OPERATIONS
(Unaudited)

Three months ended Six months ended
September 30, September 30,
------------------ -----------------
2009 2008 2009 2008
---- ---- ---- ----
Revenue:
Product revenue $2,741,578 $2,984,304 $5,214,168 $8,677,647
Royalty and
other
revenue 2,679,016 2,105,620 5,267,279 10,072,522
--------- --------- --------- ----------
Total revenue 5,420,594 5,089,924 10,481,447 18,750,169

Operating expenses:
Cost of product
revenue 918,464 1,210,644 2,188,938 3,057,045
Cost of royalty
and other
revenue 341,057 210,612 658,803 535,612
Research and
development 3,478,845 2,463,419 6,861,845 4,547,544
Selling,
general and
administrative 1,888,619 1,529,767 3,405,975 2,976,338
--------- --------- ---------- ----------
Total
operating
expenses 6,626,985 5,414,442 13,115,561 11,116,539
--------- --------- ---------- ----------

Income (loss)
from operations (1,206,391) (324,518) (2,634,114) 7,633,630
Investment income 227,364 515,235 549,783 1,047,820
Interest expense (676) 884 (1,352) (1,021)
---- --- ------ ------
Income (loss)
before
income taxes (979,703) 191,601 (2,085,683) 8,680,429
Income tax
(benefit)
provision - 49,545 - 259,545
- ------ - -------
Net income (loss) $(979,703) $142,056 $(2,085,683) $8,420,884
========= ======== =========== ==========
Earnings (loss)
per share:
Basic $(0.03) $- $(0.07) $0.27
====== == ====== =====
Diluted $(0.03) $- $(0.07) $0.27
====== == ====== =====

Weighted average
shares outstanding:
Basic 30,745,691 31,172,706 30,743,961 31,160,555
========== ========== ========== ==========
Diluted 30,745,691 31,555,896 30,743,961 31,568,948
========== ========== ========== ==========

Balance Sheet
Data: September 30, 2009 March 31, 2009
------------------ --------------
Cash, cash
equivalents
and marketable
securities* $60,223,534 $63,960,564
Working capital 46,672,506 50,234,803
Total assets 71,643,758 73,754,742
Long-term
obligations 64,100 82,398
Accumulated
deficit (115,942,944)(113,857,261)
Stockholders'
equity 67,559,130 69,123,431

*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

Laura Whitehouse, VP, Market Development of Repligen Corporation,
+1-781-419-1812