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.
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 http://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 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.
STATEMENTS OF OPERATIONS
Three months ended Six months ended
September 30, September 30,
2008 2007 2008 2007
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
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 -
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
settlement - (40,170,000) - (40,170,000)
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
(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
Basic $- $1.31 $0.27 $1.32
Diluted $- $1.29 $0.27 $1.30
Weighted average shares
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.
|SOURCE Repligen Corporation|
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