-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VFShPM+60n6ye3adwQL6+ZSaGXToOrQks2yvsnbpYqxMLJVTTBB7MqavGPjf13Q6 1YNxdxFigkOB1rAheP3Fdw== 0001169232-04-000862.txt : 20040212 0001169232-04-000862.hdr.sgml : 20040212 20040211194737 ACCESSION NUMBER: 0001169232-04-000862 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040211 ITEM INFORMATION: FILED AS OF DATE: 20040212 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPLIGEN CORP CENTRAL INDEX KEY: 0000730272 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 042729386 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14656 FILM NUMBER: 04588027 BUSINESS ADDRESS: STREET 1: 41 SEYON STREET STREET 2: BUILDING 1, SUITE 100 CITY: WALTHAM STATE: MA ZIP: 02453 BUSINESS PHONE: 7814499560 MAIL ADDRESS: STREET 1: 41 SEYON STREET STREET 2: BUILDING 1, SUITE 100 CITY: WALTHAM STATE: MA ZIP: 02453 8-K 1 d58321_8k.txt CURRENT REPORT SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ---------------------------- FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) February 11, 2004 REPLIGEN CORPORATION (Exact name of registration as specified in charter) Delaware 0-14656 04-2729386 (State or other (Commission (IRS Employer jurisdiction of File Number) Identification No.) incorporation) 41 Seyon Street, Bldg. 1, Suite 100, Waltham, MA 02453 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (781) 250-0111 --------------------------------------------------------------------- (Former name or former address, if changed since last report.) Item 12. Results of Operations and Financial Condition. On February 11, 2004, Repligen Corporation announced its financial results for the quarter ended December 31, 2003. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Form 8-K and the exhibit attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Repligen Corporation Dated: February 11, 2004 By: /s/ Walter C. Herlihy --------------------- Walter C. Herlihy President and Chief Executive Officer EXHIBIT INDEX Exhibit No. Exhibit 99.1 Press Release, dated February 11, 2004 EX-99.1 3 d58321_ex99-1.txt PRESS RELEASE EXHIBIT 99.1 RepliGen Repligen Corporation 41 Seyon Street, Building #1, Suite 100 Waltham, Massachusetts 02453 Telephone: 781-250-0111 Telefax: 781-250-0115 FOR IMMEDIATE RELEASE - -------------------------------------------------------------------------------- CONTACT: Walter C. Herlihy, Ph.D. David A. Walsey President and Chief Executive Officer The Ruth Group (781) 250-0111, ext. 2000 (646) 536-7029 Repligen Reports Third Quarter 2004 Financial Results WALTHAM, MA - February 11, 2004 - Repligen Corporation (NASDAQ: RGEN) today reported results for the third quarter of fiscal year 2004 ended December 31, 2003. Total revenue for the quarter was $1,321,000 compared to total revenue of $2,417,000 for the third quarter of fiscal year 2003. Gross profit for the quarter was $539,000, or 41% of revenue compared to $1,276,000, or 53% of revenue for the third quarter of fiscal year 2003. Operating expenses for the third quarter of fiscal year 2004 were $2,766,000 compared to $2,182,000, for the third quarter in fiscal year 2003. The net loss for the third quarter of fiscal year 2004 was $2,127,000 or $.07 per share, compared to a net loss of $766,000 or $.03 per share for the third quarter of fiscal year 2003. Cash and investments as of December 31, 2003 were $25,659,000. For the nine-month period ended December 31, 2003, total revenues were $4,801,000 compared to $5,724,000 for the same period in fiscal 2003. For the nine-month period ended December 31, 2003, gross profit was $2,423,000, or 50% of revenue compared to $3,252,000, or 57% of revenue for the same period in fiscal year 2003. Operating expenses for the nine-month period ended December 31, 2003 were $9,011,000 compared to $6,556,000 for the same period in fiscal year 2003. For the nine-month period ended December 31, 2003, the net loss was $6,295,000 or $.21 per share compared to $2,839,000 or $.11 per share for the same period in fiscal year 2003. Update on Product Development Programs CTLA4-Ig o The United States Patent and Trademark Office issued U.S. patent # 6,685,941 covering the use of CTLA4-Ig for the treatment of rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis and scleroderma. Repligen owns the exclusive rights to this patent through license agreements with The University of Michigan (the University) and the United States Navy. This patent will remain in force until 2021 and is independent from the patents on CTLA4-Ig that are the subject of the lawsuit that Repligen and the University are prosecuting against Bristol-Myers Squibb (Bristol). o Repligen and the University are prosecuting a lawsuit against Bristol for correction of inventorship of certain CTLA4 patents issued to Bristol. We are currently appealing the September 2003 finding of the District Court that Repligen and the University had not proven that a University scientist is an inventor of the patents in suit. In December 2003, we filed our written brief with the United States Court of Appeals for the Federal Circuit concerning the ruling of the District Court and anticipate that Bristol will file its brief this quarter which will be followed by oral arguments. -more- Repligen Reports Third Quarter 2004 Financial Results, February 11, 2004 Page 7 of 8 Secretin o We are currently enrolling patients in a placebo-controlled Phase 2 clinical trial of secretin in schizophrenia. The objective of this study is to determine if secretin can improve the deficits in social cognition common in patients with schizophrenia. This trial will compare the effect of twice weekly dosing of 2 different dose levels of secretin to a placebo over two weeks. There are approximately 2 million people in the United States with schizophrenia. o In January we announced that our Phase 3 clinical trial of secretin for autism failed to meet its primary endpoints. We are continuing to analyze the data and we expect to submit a report to the Food and Drug Administration (FDA) this quarter for feedback. o We plan to initiate an open-label Phase 1/2 clinical trial of secretin in Obsessive-Compulsive Disorder (OCD) in the second half of this year. Pending approval by the FDA, we plan to dose patients twice a week using subcutaneous administration. There are 3.3 million people in the United States with OCD. Uridine and Therapeutic Protein A o In 2003 we initiated an open-label Phase 1/2 clinical trial of uridine in 20 patients with bipolar disorder or major depression to assess the impact of uridine on the depressive symptoms associated with these disorders, neither of which is adequately treated with existing drugs. We expect to complete enrollment in this study in the next 3 months and plan to announce the results in mid-2004. o We own a U.S. composition of matter patent on recombinant Protein A and have licensed a patent application from the University of California, San Diego for therapeutic uses of Protein A. The patent application is based on the discovery that Protein A targets specific B-cells and claims the use of Protein A in the treatment of various autoimmune diseases and B-cell cancers. We plan to submit an Investigational New Drug application to the FDA to conduct a clinical trial with Protein A later this year. Specialty Pharmaceuticals o In May 2003, we announced the results of a large clinical trial of SecreFlo(TM) in which the use of SecreFlo(TM) significantly reduced the incidence of pancreatitis following a gastrointestinal procedure called ERCP. In February 2004, we terminated the September 1999 Licensing Agreement with ChiRhoClin, based on ChiRhoClin's failure to meet its obligations including to use best efforts to obtain FDA approval of secretin for post-ERCP pancreatitis. According to the terms of the Licensing Agreement, Repligen has the right to recover certain payments made to ChiRhoClin, totaling approximately $5 million, from ChiRhoClin's share of royalties on future sales of SecreFlo(TM). Repligen retains the right to sell SecreFlo(TM) until such payments have been recovered. About Repligen Corporation Repligen Corporation is a biopharmaceutical company committed to being the leader in the development of novel therapeutics for profound neuropsychiatric disorders with particular emphasis on applications for children. Repligen has a Specialty Pharmaceuticals business comprised of rProtein A(TM) and SecreFlo(TM), 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 www.repligen.com. -more- Repligen Reports Third Quarter 2004 Financial Results, February 11, 2004 Page 8 of 8 SELECTED FINANCIAL DATA Operating Statement Data:
Three Months Ended Nine Months Ended December 31, December 31, 2003 2002 2003 2002 -------------------------------------------------------- Total revenue $ 1,321,000 $ 2,417,000 $ 4,801,000 $ 5,724,000 Cost of revenue 782,000 1,141,000 2,378,000 2,472,000 ----------- ----------- ----------- ----------- Gross profit 539,000 1,276,000 2,423,000 3,252,000 Operating expenses: Research and development 1,850,000 1,363,000 5,181,000 3,845,000 Selling, general and administrative 916,000 819,000 3,830,000 2,711,000 ----------- ----------- ----------- ----------- Total operating expenses 2,766,000 2,182,000 9,011,000 6,556,000 ----------- ----------- ----------- ----------- Loss from operations (2,227,000) (906,000) (6,588,000) (3,304,000) Investment income 100,000 140,000 293,000 465,000 ----------- ----------- ----------- ----------- Net loss $(2,127,000) $ (766,000) $(6,295,000) $(2,839,000) =========== =========== =========== =========== Basic and diluted net loss per share outstanding $ (.07) $ (.03) $ (.21) $ (.11) =========== =========== =========== =========== Weighted average number of basic and diluted shares outstanding 29,878,000 27,316,000 29,575,000 26,979,000 =========== =========== =========== ===========
Balance Sheet Data: December 31, 2003 March 31, 2003 ----------------- -------------- Cash and investments $25,659,000 $18,909,000 Total assets $33,150,000 $26,793,000 Stockholders' equity $30,343,000 $24,550,000 This 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, management's strategy, plans and objectives for future operations, clinical trials and results, litigation strategy, product research, intellectual property, development and manufacturing plans and performance such as the anticipated growth in target markets, including, without limitation, the market for autoimmune disease treatment and the monoclonal antibody market 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 success of our clinical trials and 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 current and future litigation regarding our patent and other intellectual property rights, the risk of litigation with collaborative partners, our limited sales and marketing experience and capabilities, our limited manufacturing capabilities and our dependence on third-party manufacturers and value-added resellers, our ability to hire and retain skilled personnel, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies that may develop new approaches to the treatment of our targeted diseases, our history of losses and expectation of incurring continued losses, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, our volatile stock price, the effects of our anti-takeover provisions, 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. ### -----END PRIVACY-ENHANCED MESSAGE-----