WALTHAM, Mass., Nov. 6 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) today reported results for the second quarter of fiscal year
2009, ended September 30, 2008. Total revenue for the quarter was $5,090,000
compared to total revenue of $5,352,000 for the second quarter of fiscal year
2008 ended September 30, 2007. Total revenue was comprised of product revenue
and royalty and research revenue. Product revenue, comprised of Protein A
revenue, for the second quarter of fiscal year 2009 was $2,984,000 and royalty
and research revenue was $2,106,000, comprised primarily of royalty payments
from Bristol-Myers Squibb on the U.S. sales of Orencia(R).
Operating expenses for the second quarter of fiscal year 2009 were
$5,414,000 compared to $4,752,000 for the same time period in fiscal year
2008. This increase in operating expenses of $662,000 was primarily the
result of increased spending associated with our Phase 3 clinical trial of
RG1068 for pancreatic imaging, and preparations for our Phase 2b clinical
trial of RG2417 for bipolar depression, as well as increased research and
development costs associated with our efforts to identify a clinical candidate
for Friedreich's ataxia. These increases in spending were partially offset by
reductions in selling, general and administrative expenses, most notably a
decrease in legal expenses.
The net income for the second quarter of fiscal year 2009 was $142,000 or
$0.00 per diluted share, compared to net income for the second quarter of
fiscal year 2008 of $40,306,000 or $1.29 per diluted share. The prior year
results were favorably impacted by a $40,170,000 gain from the settlement in
the litigation with ImClone Systems, Inc. during fiscal year 2008. Cash, cash
equivalents and marketable securities as of September 30, 2008 were
$65,606,000 compared to $60,589,000 as of March 31, 2008.
"We are in a strong position to execute our product development plan
despite the recent turmoil in the financial markets," stated Walter C.
Herlihy, President and Chief Executive Officer of Repligen Corporation. "As
of September 30th, we had $65 million or $2.10 per share in cash and
investments, no debt and we project that on an operating basis we will be cash
flow positive in fiscal year 2009 with $28 to $30 million in revenue. We
believe our stock is undervalued, and we intend to continue to repurchase our
shares under the previously announced 1.25 million share buyback."
For the six-month period ended September 30, 2008, total revenue was
$18,750,000. Royalty and other revenue for the six-month period ended
September 30, 2008 was $10,073,000. Operating expenses for the six-month
period ended September 30, 2008 were $11,117,000, compared to $10,746,000,
exclusive of the net gain of $40,170,000 from litigation settlement, for the
same period in fiscal year 2007. Net income for the six-month period ended
September 30, 2008 was $8,421,000 or $0.27 per diluted share compared to a net
gain of $40,546,000 or $1.30 per diluted share in the same period in fiscal
year 2008.
Corporate Update
RG1068 for Imaging of the Pancreas
We are currently enrolling patients in a Phase 3 clinical trial of RG1068,
synthetic human secretin, designed to assess the ability of RG1068 enhanced
magnetic resonance imaging (MRI) to improve the detection of 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 25 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 300,000 procedures
conducted in the United States and Europe each year that may benefit from
enhancement with RG1068.
RG2417 for Bipolar Disorder
We have initiated 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. This study is designed to assess
the efficacy and safety 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). This study is
based on the positive results of a 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 CGI-BP-C (p=0.04).
HDAC Inhibitors for Friedreich's Ataxia and Huntington's Disease
We are currently developing inhibitors of histone deacetylases (HDACs)
which may have utility in treating progressive, inherited neurodegenerative
diseases such as Friedreich's ataxia and Huntington's disease. We have
identified several potential clinical candidates and are further
characterizing these leads in animal models for their pharmacologic,
toxicologic and pharmacodynamic profiles. Repligen announced receipt of a $1
million research grant from the Muscular Dystrophy Association and a $125,000
grant from the Friedreich's Ataxia Research Alliance and the National Ataxia
Foundation. The grants will further the development, characterization and
selection of a drug candidate for human clinical trials as well as support the
development of tools ("biomarkers") to monitor the desired biological impact
of the drugs in clinical trials.
Repligen is also studying this class of compounds in order to identify a
potential treatment for Huntington's disease. Scientists at the Scripps
Research Institute recently published results of a preclinical study
demonstrating that HDAC inhibitors improved disease symptoms in a transgenic
animal model of the disease. The study, entitled "The HDAC Inhibitor 4b
Ameliorates the Disease Phenotype and Transcriptional Abnormalities in
Huntington's Disease Transgenic Mice" was published in the Proceedings of the
National Academy of Sciences.
Stock Repurchase Program
In June 2008, Repligen announced that its Board of Directors authorized
the repurchase of up to 1.25 million shares of its common stock. To date, the
Company has repurchased more than 350,000 shares for an aggregate cost of
approximately $1.4 million.
Quarterly Conference Call
Walter C. Herlihy, Ph.D., will host a conference call and webcast on
Thursday, November 6th at 10:00 a.m. EST, to review second 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 www.repligen.com or you may also listen to the live broadcast by
calling (866) 825-3209 for domestic calls and (617) 213-8061 for international
calls. Participants must provide the following passcode: 62476438. 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
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 www.repligen.com.
REPLIGEN CORPORATION
STATEMENTS OF OPERATIONS
(Unaudited)
Three months ended Six months ended
September 30, September 30,
2008 2007 2008 2007
Revenue:
Product revenue $2,984,304 $5,156,348 $8,677,647 $10,887,824
Royalty and other
revenue 2,105,620 195,973 10,072,522 443,315
Total revenue 5,089,924 5,352,321 18,750,169 11,331,139
Operating expenses:
Cost of product
revenue 1,210,644 1,412,428 3,057,045 3,126,727
Cost of royalty and
other revenue 210,612 - 535,612 -
Research and
development 2,463,419 1,153,994 4,547,544 3,291,320
Selling, general and
administrative 1,529,767 2,185,799 2,976,338 4,327,930
Net gain from
litigation
settlement - (40,170,000) - (40,170,000)
Total operating
expenses 5,414,442 (35,417,779) 11,116,539 (29,424,023)
Income (loss) from
operations (324,518) 40,770,100 7,633,630 40,755,162
Investment income 515,235 365,900 1,047,820 623,267
Interest income
(expense) 884 (2,451) (1,021) (4,902)
Income (loss) before
income taxes 191,601 41,133,549 8,680,429 41,373,527
Provision for income
taxes (49,545) (827,471) (259,545) (827,471)
Net income (loss) 142,056 40,306,078 8,420,884 40,546,056
Earnings (loss) per
share:
Basic $- $1.31 $0.27 $1.32
Diluted $- $1.29 $0.27 $1.30
Weighted average shares
outstanding:
Basic 31,172,706 30,767,384 31,160,555 30,667,249
Diluted 31,555,896 31,224,386 31,568,948 31,150,073
Balance Sheet Data: September 30, 2008 March 31, 2008
Cash and marketable securities* $65,605,949 $60,589,054
Working capital 53,762,900 49,831,378
Total assets 76,020,837 68,839,707
Long-term obligations 130,365 143,043
Accumulated deficit (112,068,850) (120,576,819)
Stockholders' equity 72,784,029 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.
