For the six-month period ended September 30, 2011, total revenue was $16,285,000 compared to $14,317,000 for the same period in fiscal year 2011. Operating expenses for the six-month period ended September 30, 2011 were $15,854,000 compared to $12,901,000 for the same period in fiscal year 2011. Net income for the six-month period ended September 30, 2011 was $549,000 or $0.02 per diluted share compared to $1,611,000 or $0.05 per diluted share for the same period in fiscal year 2011.Corporate Update Expanding and Diversifying the Bioprocessing Business Today we announced that we have acquired the business of Novozymes Biopharma Sweden AB which creates a world-leading supplier of products for manufacturing biologic drugs. This acquisition delivers on our goal of transitioning the company into a commercially focused organization by significantly augmenting our product portfolio and providing a path to sustainable profitability. See separate press release for details. RG1068 (SecreFlo™) for Pancreatic Imaging We are developing SecreFlo™ (RG1068) to improve detection of pancreatic duct abnormalities in combination with magnetic resonance imaging (MRI) in patients with pancreatitis. SecreFlo™ has been shown in a Phase 3 clinical trial to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis. This quarter we announced that we have received approval from the European Medicines Agency’s Pediatric Committee (PDCO) on the design of the Pediatric Investigation Plan for SecreFlo™ (RG1068). This positive action taken by the PDCO will enable us to file a marketing application for SecreFlo™ in Europe by the end of the year. We are currently preparing a New Drug Application (NDA) for SecreFlo™ for submission to the FDA next month. SecreFlo™ has been granted Fast Track and Orphan Designation, and we intend to request that the FDA grant our application priority review when we file our NDA.
There are approximately 300,000 MRI procedures conducted in patients with pancreatitis in the U.S. and Europe each year that could directly benefit from the addition of SecreFlo™. In addition, a pilot study is currently being conducted to evaluate the ability of SecreFlo™ to improve detection and characterization of pancreatic cancer in combination with contrast-enhanced MRI and computed tomography. Early detection of pancreatic cancer will increase the identification of patients who are candidates for surgery and may improve patient outcomes. There are approximately 250,000 people worldwide diagnosed with pancreatic cancer each year.Orphan CNS Drugs We are developing RG3039 for Spinal Muscular Atrophy (SMA) and RG2833 for Friedreich’s ataxia (FA) which are serious and debilitating neurodegenerative diseases typically diagnosed in childhood. SMA and FA are characterized by a defect in a single gene which results in diminished production of a key protein. During the quarter we enrolled 24 subjects in a Phase 1 clinical study of RG3039 in healthy volunteers. To date there have been no serious adverse events in any subject. We also filed an application in Italy to initiate a Phase 1 study of RG2833 in patients with Friedreich’s ataxia from which we expect a response this quarter. We are currently engaged in discussions with numerous companies to explore whether a partnership would accelerate the global development and ultimately maximize the commercial potential of these programs. There are approximately 20,000 patients in the U.S. and Europe with SMA and 15,000 patients with FA worldwide, a combined market opportunity greater than $1 billion. Conference Call Dr. Walter, C. Herlihy, President and Chief Executive Officer of Repligen will host a conference call and webcast on Friday October 28, 2011 at 8:30 am EDT to discuss the details of the acquisition, the prospects of the combined businesses and other business matters including our Q2 FY2012 financial results.
This call is being webcast by Thomson/CCBN and can be accessed via Repligen’s website at www.repligen.com. If you are unable to access the webcast, you may listen live by calling (866) 831-6267 for domestic calls and (617) 213-8857 for international calls. Participants must provide the following passcode: 27485966. For those who cannot participate in the live conference call, an archive of the audio webcast will be available shortly after the call on Repligen’s website www.repligen.com. You may also access the audio archive by dialing (888) 286-8010 for domestic calls and (617) 801-6888 for international calls and provide the following passcode: 14900928.About Repligen Corporation Repligen Corporation is a leading supplier of critical technologies and ingredients used to manufacture biologic drugs. Repligen also applies its expertise in biologic development to Secreflo™, a novel imaging candidate for the diagnosis of a variety of pancreatic diseases. In addition, we have two early stage CNS rare disease programs which are advancing into Phase 1 clinical trials. Repligen’s corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested at www.repligen.com.
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three months ended September 30,||Six months ended September 30,|
|Royalty and other revenue||2,889,458||2,891,192||6,184,791||5,632,252|
|Cost of product revenue||2,092,815||1,471,561||3,645,624||2,737,311|
|Cost of royalty and other revenue||418,419||376,991||834,289||748,733|
|Research and development||3,074,625||3,119,279||6,592,086||5,814,327|
|Selling, general and administrative||2,493,093||1,812,617||4,782,210||3,600,854|
|Total operating expenses||8,078,952||6,780,448||15,854,209||12,901,225|
|Income from operations||552,426||526,530||430,894||1,415,625|
|Income before income taxes||604,673||623,209||549,077||1,611,262|
|Income tax provision||-||-||-||-|
|Earnings per share:|
|Weighted average shares outstanding:|
|Balance Sheet Data:||September 30, 2011||March 31, 2011|
|Cash, cash equivalents and marketable securities*||$||58,273,972||$||61,503,265|
|*does not include restricted cash|