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Repligen Reports Fourth Quarter and Fiscal Year 2006 Financial Results -- Fiscal Year Operating Loss of $1,220,000 and Net Income of $697,000

11 June 2006

Repligen Corporation (Nasdaq: RGEN) today reported results for the fourth quarter and fiscal year ended March 31, 2006. Total revenue for fiscal year 2006 was $12,911,000 compared to total revenue of $9,360,000 for the fiscal year ended March 31, 2005, an increase of $3,551,000. Product revenue for fiscal year 2006 consisting of Protein A and SecreFlo(R) sales, was $12,529,000 compared to $9,360,000 for fiscal year 2005, an increase of 34%. Gross profit on product revenue for fiscal year 2006 was $8,978,000 (72%) compared to $5,472,000 (58%) for fiscal year 2005. The increase in product revenue was primarily due to higher customer demand. Profit margin was impacted favorably by higher revenue and the decreased royalty owed for SecreFlo(R), our secretin product which is marketed to gastroenterologists for diagnosis of pancreatitis and gastrinoma, a rare form of cancer.


Operating expenses for the fiscal year ended March 31, 2006 were $14,131,000 compared to $13,522,000 for the same period in fiscal year 2005. Operating loss for the fiscal year ended March 31, 2006 was $1,220,000 compared to $4,162,000 for the same period in fiscal year 2005. Net income for fiscal year 2006 was $697,000 or $.02 per share, compared to a net loss of $2,984,000 or $.10 per share for fiscal year 2005. Cash and investments as of March 31, 2006 were $23,408,000 compared to $23,523,000 on March 31, 2005.


"We are pleased to report that we have achieved our financial guidance, and our operational performance is consistent with our objective to build a self-sustaining, integrated biopharmaceutical company," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "Profits from our product sales are being reinvested in the development of our product pipeline, the expansion of our manufacturing capacity and in the maintenance and enforcement of our intellectual property rights."


Total revenue for the fourth quarter of fiscal year 2006 was $2,885,000 compared to $2,995,000 for the same period in fiscal year 2005, a decrease of 4%. Gross profit on product revenue for the fourth quarter of fiscal year 2006 was $1,955,000 (69%) compared to $1,972,000 (66%) for the fourth quarter of fiscal year 2005. Operating expenses for the fourth quarter of fiscal year 2006 were $3,899,000 compared to $3,544,000, for the fourth quarter of fiscal year 2005. The net loss for the fourth quarter of fiscal year 2006 was $820,000 or $.03 per share, compared to a net loss of $427,000 or $.01 per share for the fourth quarter of fiscal year 2005.


Update on Product Development Programs


Secretin


* Secretin is a gastrointestinal hormone involved in the process of


digestion, which has also been shown to have activity in the central


nervous system. Secretin signals the release of fluids into the ducts


of the pancreas, a result that has been documented in the literature to


improve MRI imaging of the pancreas. Following discussions with the


FDA on the criteria for approval to market our synthetic human secretin


product (RG1068) for improvement of MRI imaging of the pancreas, we


have initiated a clinical study to evaluate the use of secretin to aid


in the detection of structural abnormalities of the pancreas. We


believe there may be more than 100,000 potential MRI images of the


pancreas in the U.S. each year that could benefit from the use of


secretin.


* We have completed enrollment in a pilot study to assess the impact of


secretin on a surrogate marker for a cognitive deficit characteristic


of patients with schizophrenia. A preliminary review of the blinded


data suggests that while there may be an effect of drug treatment,


further analysis of the data will be necessary to understand the


potential impact of secretin on this patient population.


Uridine


* In February, we announced that we had initiated a Phase 2 clinical trial


of uridine in bipolar depression. This is a multi-center, dose


escalating study in which 80 patients will receive either an oral


formulation of uridine or a placebo for 6 weeks. Patients will be


evaluated for the safety and effectiveness of uridine in treating the


symptoms of bipolar depression. This study is being conducted under a


development agreement with the Stanley Medical Research Institute under


which Repligen will receive approximately $1,000,000 in funding. The


Stanley Medical Research Institute is the largest nonprofit provider of


funding for research on schizophrenia and bipolar disorder in the


United States.


Intellectual Property


* In January, Repligen and The University of Michigan jointly filed a


complaint against Bristol-Myers Squibb Company (Bristol) (NYSE: BMY) in


the United States District Court for the Eastern District of Texas for


infringement of U.S. Patent No. 6,685,941 for the commercial sale of


Orencia(R). The patent, entitled "Methods of Treating Autoimmune


Disease via CTLA4-Ig," covers methods of using CTLA4-Ig to treat


rheumatoid arthritis, as well as other therapeutic methods. Repligen


has exclusive rights to this patent from its owners, the University of


Michigan and the U.S. Navy and we intend to seek a royalty bearing


license agreement with Bristol whether through litigation or


negotiation. In February, Bristol answered the complaint and


counterclaimed seeking a judgment that the patent is invalid and


unenforceable and that Bristol does not infringe the patent.


* Repligen and MIT previously filed suit against ImClone, alleging that


ImClone has infringed U.S. patent No. 4,663,281 in its production of


Erbitux(R). In February, the Court heard oral argument on summary


judgment motions brought by plaintiffs Repligen and MIT and defendant


ImClone on the issue of exhaustion of patent rights. The Court may: 1)


rule in Repligen's favor, dismissing ImClone's patent exhaustion


defense and send the case to trial, 2) deny both parties motions and


send the case to trial, or 3) rule in ImClone's favor and dismiss


Repligen's suit, subject to appeal. We hope for a ruling soon on the


summary judgment motions but there is no deadline by which the Court


must act.


Quarterly Conference Call


Walter C. Herlihy, Ph.D., will host a conference call and webcast on Thursday, June 8th at 11:00 a.m. EDT, to report fourth quarter and fiscal year 2006 financial results. This call may be accessed via Repligen's website at http://www.repligen.com or you may listen to the live broadcast by dialing (866) 356-3095 for domestic calls and (617) 597-5391 for international calls, enter passcode: 95035956.


About Repligen Corporation


Repligen Corporation is a biopharmaceutical company committed to being the leader in the development of novel therapeutics for profound neuropsychiatric disorders and autoimmune disease. Repligen has a Specialty Pharmaceuticals business comprised of rProtein A(TM) and SecreFlo(R), the profits from which will be used to partially support the development of our proprietary products. 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.


SELECTED FINANCIAL DATA


Operating Statement Data:


Three months ended Years ended


March 31, March 31,


2006 2005 2006 2005


____________________________________________________


Revenue:


Product revenue $2,843,000 $2,995,000 $12,529,000 $9,360,000


Other revenue 42,000 - 382,000 -


___________ ___________ ___________ ___________


Total revenue 2,885,000 2,995,000 12,911,000 9,360,000


Operating expenses:


Cost of product


revenue 888,000 1,023,000 3,551,000 3,888,000


Research and


development 1,413,000 1,334,000 5,163,000 5,037,000


Selling, general


and


administrative 1,598,000 1,187,000 5,417,000 4,597,000


___________ ___________ ___________ ___________


Total operating


expenses 3,899,000 3,544,000 14,131,000 13,522,000


Income (loss)


from operations (1,014,000) (549,000) (1,220,000) (4,162,000)


Interest expense (3,000) - (3,000) -


Investment income 197,000 122,000 750,000 428,000


Other income - - 1,170,000 750,000


___________ ___________ ___________ __________


Net income (loss) $(820,000) $(427,000) $697,000 $(2,984,000)


=========== =========== =========== ===========


Earnings Per Share:


Basic and diluted $(0.03) $(0.01) $0.02 $(0.10)


=========== =========== =========== ===========


Weighted average


shares outstanding:


Basic 30,202,000 30,080,000 30,125,000 30,062,000


========== =========== =========== ===========


Diluted 30,202,000 30,080,000 30,691,000 30,062,000


========== =========== =========== ===========


Balance Sheet Data:


As of March 31,


2006 2005


__________________________


Cash and marketable securities* $23,408,000 $23,523,000


Total assets 28,599,000 27,607,000


Stockholders' equity 25,433,000 24,290,000


*does not include restricted cash


This release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934. 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, management's strategy, plans and objectives for future operations, clinical trials and results, product development and manufacturing plans and performance such as the anticipated growth in the monoclonal antibody market, projected growth in product sales, opportunities for collaboration and licensing, and our intellectual property portfolio 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.


CONTACT:


Walter C. Herlihy, Ph.D.


President and Chief Executive Officer


(781) 419-1900


Laura Whitehouse


Vice President, Market Development


(781) 419-1812

Source: prnewswire


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