GTC Biotherapeutics Reports Fourth Quarter and Year End 2006 Financial Results.FRAMINGHAM, Mass. -- GTC GTC See: Good 'til cancelled order GTC See good-till-canceled order (GTC). Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB GTCB Gulf Tax Credit Bond (Alabama, Louisiana, Mississippi, USA) ) reported today its financial results for the fourth quarter and year ended December 31, 2006. The net loss for the fourth quarter of 2006 was $7.4 million, or $0.10 per share, compared to $8.3 million, or $0.15 per share in the fourth quarter of 2005. The net loss for the 2006 financial year was $35.3 million, or $0.53 per share, compared to $30.1 million, or $0.62 per share, for the 2005 financial year. "GTC went through a transformation in 2006, catalyzed by the approval of ATryn([R]) in Europe, the first approval of a transgenically produced therapeutic product anywhere in the world," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer. "We have two important partner relationships with LEO Pharma A/S and LFB LFB Legislative Fiscal Bureau LFB London Fire Brigade LFB Linear Frame Buffer LFB Left Fullback (soccer) LFB Lyman Frank Baum (The Wizard of Oz author) LFB Liquid Factor Boiling LFB Low-Frequency Beacon Biotechnologies which enable us to further develop ATryn([R]) and expand our portfolio of recombinant plasma proteins. We now have a portfolio of proprietary products that are capable of driving significant future value and we have strengthened our balance sheet. As we move forward through 2007, we intend to increase our strategic focus on partnering activities to provide additional resources and momentum to our product development programs." ATryn([R]), our recombinant form of human antithrombin, was approved by the European Commission European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community for the prophylactic treatment prophylactic treatment n. The institution of measures to protect a person from a disease to which he or she has been, or may be, exposed. Also called preventive treatment. of deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. in patients with hereditary antithrombin deficiencies that are undergoing surgical procedures Surgical procedures have long and possibly daunting names. The meaning of many surgical procedure names can often be understood if the name is broken into parts. For example in splenectomy, "ectomy" is a suffix meaning the removal of a part of the body. "Splene-" means spleen. . Our partner LEO is planning to introduce the ATryn([R]) product at the International Society of Thrombosis and Haemostasis hemostasis, haemostasis the stoppage of bleeding or cessation of the circulation of the blood; stagnation of the blood in a part of the body. Also hemostasia, haemostasia. See also: Blood and Blood Vessels Noun 1. conference in July 2007. In addition, LEO has obtained Scientific Advice from the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products. Roughly parallel to the U.S. on the design of a Phase II dose ranging study for the treatment of disseminated intravascular coagulation disseminated intravascular coagulation n. Abbr. DIC A hemorrhagic disorder that occurs following the uncontrolled activation of clotting factors and fibrinolytic enzymes throughout small blood vessels, resulting in tissue necrosis and , or DIC DIC diffuse intravascular coagulation; disseminated intravascular coagulation. DIC abbr. disseminated intravascular coagulation Disseminated intravascular coagulation (DIC) , associated with severe sepsis severe sepsis A condition defined clinically as 'Sepsis associated with organ dysfunction, hypotension, or hypoperfusion abnormalities (which include) …lactic acidosis, oliguria, or an acute alteration in mental status . Clinical sites to initiate patient enrollment for this Phase II study are being opened. We have rights to use the Phase II data outside the LEO territories of Europe, Canada, and the Middle East, and we will receive payment from LEO for the product used in its clinical studies. In the United States, we are continuing our pivotal Phase III active and historical comparison trials of ATryn([R]) in the hereditary deficiency indication and we expect to file for approval with the Food and Drug Administration around the end of 2007. We intend to develop ATryn([R])in Japan through further partnering and have begun initial discussions with potential interested partners. We believe that the worldwide market potential of ATryn([R]) is $500 million to $700 million, primarily in acquired antithrombin deficiency indications such as DIC. Antithrombin is a plasma protein with anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting). and anti-inflammatory properties. We have developed goats that have the human antithrombin gene linked to a milk-protein promoting gene so that they express this protein in their milk. This transgenic approach provides the opportunity to produce recombinant forms of proteins, such as antithrombin, that are difficult to express in economically viable quantities in conventional production systems. We entered a strategic collaboration with LFB Biotechnologies, or LFB, in late 2006 that includes development of recombinant human factor VIIa, or rhFVIIa, a clotting factor clot·ting factor n. Any of various plasma components involved in the clotting of blood, including fibrinogen, prothrombin, thromboplastin, and calcium ion. Also called coagulation factor. in coagulation coagulation (kōăg'y lā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or . The first indication
planned for this program is in the treatment of type A and type B
hemophilia where patients have developed inhibitors to clotting factors Clotting factorsSubstances in the blood that act in sequence to stop bleeding by forming a clot. Mentioned in: Partial Thromboplastin Time clotting factors, n. VIII or IX. An independent analyst report estimates the total worldwide market for rhFVIIa will be $2 billion by 2012, which is the year when the patents on the current marketed product, NovoSeven([R]), expire. The strategic collaboration with LFB includes potential development of additional recombinant human plasma proteins and monoclonal antibodies. An evaluation of these opportunities is in process. Our portfolio of recombinant plasma proteins includes recombinant human alpha-1 antitrypsin, for which we have already established a production herd and which is in preclinical development. Last week, we entered into an agreement with PharmAthene under which we will provide process development and clinical supply manufacturing services for Protexia([R]), a recombinant form of human butyrylcholinesterase produced in the milk of transgenic goats. Protexia([R]) is being developed by PharmAthene as a pre- and post-exposure therapy for military or civilian victims of a chemical nerve agent attack. The Protexia([R]) program, similar to the continuing supply relationship for Merrimack Pharmaceuticals' MM-093 product, will use our transgenic production technology to enable development of the partner's protein that does not express in economically viable quantities in traditional bioreactor-based methods. We also intend to develop through a partnering relationship our monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing to the CD137 receptor in the human immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. . This antibody has been reported to demonstrate potential therapeutic value in preclinical models of solid tumors and autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . We have established production animals and are proceeding to preclinical development to support clinical studies. Cash Position We ended 2006 with approximately $43.8 million of cash and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has . The third and final equity investment by LFB on January 3, 2007, as well as payments from LEO for delivery in January 2007 of Phase II clinical material that was manufactured in late 2006, provided us with additional cash and marketable securities totaling about $7 million, which on a pro forma As a matter of form or for the sake of form. Used to describe accounting, financial, and other statements or conclusions based upon assumed or anticipated facts. The phrase pro forma basis would put our year-end cash and marketable securities at approximately $51 million. During 2006, we had a net increase of $7.6 million in cash and marketable securities including financing activities. We used $24.6 million of cash in operations. For 2007, we expect our net cash use to be in the range of $26 to 29 million. The net cash use includes forecasted sales of ATryn([R]) in the approved indication approved indication, n 1. reliable signs that a certain remedy should be used. Not synonymous with “authorized.” 2. FDA-approved condition for a drug or other treatment that allows labeling. and to LEO for the DIC study, as well as receipts from new and existing contracts and planned research and development activities in support of ATryn([R]) and our other programs. The Phase II DIC clinical study activities in 2007 will be conducted and funded by LEO. In December 2006, we completed a re-financing of our senior debt facility with GE Capital. This refinancing provided an additional $2.8 million of proceeds while extending the amortization period for $8 million of the debt facility, which reduces our annual debt service. After the refinancing, we had a total of $10 million of debt outstanding with GE. Financial Results Revenues were $2.8 million for the fourth quarter of 2006, compared with $0.6 million in the fourth quarter of 2005. Revenues for 2006 were $6.1 million, a 48% increase from $4.2 million in 2005. Revenues increased primarily due to shipment of initial clinical supply material to LEO for the DIC Phase II study as well as amortization of the milestone payments previously received. Costs of revenue and operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. were $41.8 million for 2006, 23% higher than the $33.9 million in 2005, primarily due to increased research and development expenses, which totaled $25.4 million for 2006, an increase of 20% over the $21.1 million in 2005. The increase was driven primarily by validation costs and costs associated with manufacturing ATryn([R]) from the current process that were in excess of the maximum selling price to LEO and with process development activities for increasing the scale of ATryn([R]) manufacturing. Total selling, general and administrative expenses in 2006 were $9.7 million, a 15% increase over the $8.4 million of 2005. This increase was primarily due to increased patent and legal costs, the expense associated with the special shareholder vote in the fourth quarter of 2006, and the non-cash expense associated with equity-based compensation. The weighted average number of shares outstanding increased from 53.6 million shares for the fourth quarter of 2005 to 73.6 million shares in the fourth quarter of 2006. The weighted average number of shares outstanding increased from 48.7 million shares in 2005 to 66.9 million shares in 2006. The increases in the weighted average shares outstanding primarily reflect the issuance of common stock in financing transactions. However, the shares of preferred stock Stock shares that have preferential rights to dividends or to amounts distributable on liquidation, or to both, ahead of common shareholders. Preferred stock is given preference over common stock. Holders of preferred stock receive dividends at a fixed annual rate. issued to LFB are not included in the weighted average number of shares outstanding. Our total outstanding equity capital, including the common share equivalents issuable upon conversion of LFB's preferred stock, at the end of 2006 were approximately 88.2 million and were approximately 91.8 million upon completion of the common stock installment of LFB's equity investment in January 2007. Conference Call Information GTC 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 1-866-312-4865. The dial-in number from outside the United States is 1-617-213-8050. The participant passcode is 63614331. The webcast may be found at www.gtc-bio.com. About GTC Biotherapeutics, Inc. GTC Biotherapeutics develops, produces, and commercializes therapeutic proteins through transgenic animal Transgenic animal Animals that have had genes from other species inserted into their genetic code. Mentioned in: Glycogen Storage Diseases technology. In August 2006, ATryn([R]), GTC's recombinant form of human antithrombin, was approved by the European Commission for use in patients with hereditary antithrombin deficiency undergoing surgical procedures. This was the first approval anywhere in the world of a therapeutic protein produced from a transgenic animal. ATryn([R])is in phase III studies to support a filing in the United States requesting approval in the hereditary deficiency indication. In addition, GTC has established a strategic collaboration with LFB Biotechnologies of France to jointly develop recombinant forms of human plasma proteins and monoclonal antibodies. The first program of the collaboration will be to develop recombinant human factor VIIa as a potential treatment for hemophilia in patients with antibodies to other coagulation factors. GTC has also recently been granted 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 those 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, including without limitation statements regarding prospects for portfolio of proprietary products, the expected net utilization of cash and marketable securities in 2007, the anticipated commercial launch of ATryn([R]), the anticipated clinical development of the DIC indication with LEO and the potential market for ATryn([R]), the timing for the filing of a BLA BLA abbr. Bachelor of Liberal Arts for ATryn([R]) in the US, planned development of our other programs, and plans for entering into additional partnerships, 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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. [TABLE OMITTED] |
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