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![]() ![]() ![]() ![]() ![]() | GTC BIOTHERAPEUTICS REPORTS FOURTH QUARTER AND YEAR END 2008 FINANCIAL RESULTS
FRAMINGHAM, MA – February 27, 2009 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) reported today its financial results for the fourth quarter and year ended December 28, 2008. Revenues were $1.0 million for the fourth quarter of 2008, compared with $3.1 million for the fourth quarter of 2007. Revenues for 2008 increased to $16.7 million from $13.9 million for 2007. Revenues for the full year increased primarily due to the increase in services provided to PharmAthene for development of their recombinant human butyrlcholinesterase program, Protexia®. The reduction in revenues for the fourth quarter was primarily a result of the timing of completion of work on external programs and completion of shipments of ATryn® to LEO Pharma A/S in earlier quarters during 2008. The net loss for the fourth quarter of 2008 was $6.2 million, or $0.06 per share, compared to $9.8 million, or $0.13 per share for the fourth quarter of 2007. The net loss for the 2008 financial year was $22.7 million, or $0.23 per share, compared to $36.3 million, or $0.47 per share, for the 2007 financial year. “The recent approval of ATryn® in the US is an historic milestone for GTC, marking the FDA’s first approval of a transgenically produced therapeutic protein after rigorous review of both the product and our animals,” stated Geoffrey F. Cox, Ph.D., GTC’s Chairman of the Board and Chief Executive Officer. “We look forward to building on this success as ATryn® is commercialized and developed further with our partner OVATION Pharmaceuticals and in expanding our partnering relationships in our recombinant plasma protein and monoclonal antibody portfolio.” Significant product development events for the year and outlook for 2009: ATryn® (recombinant human antithrombin)
GTC ended 2008 with approximately $11.6 million of cash and marketable securities. GTC used $20 million of cash and marketable securities in 2008, net of the $5.4 million of financing proceeds received from a financing transaction in February 2008 and the $10.4 million in net proceeds from the convertible debt financing with LFB in December 2008. GTC expects a similar cash use for fiscal 2009, within a range of $18 to 22 million, including projected receipts from new or expanded partnerships not currently contracted. The financial report on Form 10-K for the financial year ended December 28, 2008 to be filed with the Securities and Exchange Commission will include an audit opinion from GTC’s auditors, PricewaterhouseCoopers LLP, which will refer to substantial doubt regarding GTC’s ability to continue as a going concern based on the amount of cash and marketable securities on its balance sheet at December 28, 2008 and its expected cash use in 2009. Inclusion of this information in this release satisfies Nasdaq Marketplace Rule 4350 (b) (1) (B) for public announcement of the auditors’ statement of uncertainty and in no way alters GTC’s plans for addressing the underlying circumstances. Other Financial ResultsCosts of revenue and operating expenses were $39.9 million for 2008, approximately 21% lower than the $50.3 million in 2007. The year-to-year decrease was primarily due to the completion of activities in the ATryn® development program and $5.1 million of funding received from LFB for GTC’s expenses in programs under the joint venture. The weighted average number of shares outstanding increased from 78.1 million shares for the fourth quarter of 2007 to 102.9 million shares in the fourth quarter of 2008. The weighted average number of shares outstanding increased from 77.9 million shares for 2007 to 98.2 million shares for 2008. The increases in the weighted average shares outstanding primarily reflect the issuance of common stock in financing transactions. Conference Call InformationGTC Biotherapeutics will discuss these results and its business outlook in a web cast conference call at 10:00 a.m. (Eastern) today. The dial-in number from inside the United States is 1-888-713-4215. The dial-in number from outside the United States is 1-617-213-4867. The participant passcode is 57945237. The webcast may be found at www.gtc-bio.com. About GTC Biotherapeutics, Inc.GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. ATryn®, GTC’s recombinant human antithrombin, has been approved for use in the United States and Europe. ATryn® is the first and only transgenically produced product to be approved for therapeutic use anywhere in the world. In addition to ATryn®, GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factors VIIa, VIII, and IX, which are being developed for the treatment of hemophilia, and alpha-1 antitrypsin. GTC also has a monoclonal antibody portfolio that includes a monoclonal antibody to CD20 and a monoclonal antibody to CD137. GTC’s intellectual property includes a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC’s transgenic production platform is particularly well suited to enabling cost effective development of proteins that are difficult to express in traditional recombinant production systems as well as proteins that are required in large volumes. Additional information is available on the GTC web site, http://www.gtc-bio.com. This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding prospects for development of the portfolios of recombinant plasma proteins and monoclonal antibodies, the expected net utilization of cash and marketable securities in 2009, the prospects market launch of ATryn® in the US and for development in additional indications, the prospects for establishing new partnering relationships, including for ATryn® in Europe and for follow-on biologics,, the planned clinical development of GTC’s other programs, and plans for entering into additional collaborations, including for additional products. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K and its other periodic reports filed with the Securities and Exchange Commission, including the uncertainties associated with conducting clinical studies, and the risks and uncertainties associated with dependence upon the actions of partners and regulatory agencies. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law. CLICK HERE TO VIEW FOURTH QUARTER AND YEAR END 2008 FINANCIAL RESULTS CONTACT:GTC Biotherapeutics, Inc. Thomas E. Newberry Vice President, Corporate Communications and Government Relations (508) 370-5374 or tom.newberry@gtc-bio.com |
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