WALTHAM, Mass., Aug. 7 MA-Repligen-Q1-earns
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 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
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
SELECTED FINANCIAL DATA
Unaudited
Three months ended June 30,
2008 2007
Revenue:
Product revenue $5,693,343 $5,731,476
Royalty and other revenue7,966,902 247,342
Total revenue 13,660,2455,978,818
Operating expenses:
Cost of product revenue 1,846,4011,714,299
Cost of royalty and other revenue 325,000-
Research and development 2,084,1252,137,326
Selling, general and administrative 1,446,5712,142,131
Total operating expenses 5,702,0975,993,756
Income (loss) from operations 7,958,148 (14,938)
Investment income532,585 257,367
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,
20082008
Cash, cash equivalents, and
marketable securities* $66,126,165 $60,589,054
Working capital51,476,498 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
