BioMimetic Therapeutics Reports 2006 Fourth Quarter and Year-end Results.Company Receives Clearance to Initiate Enrollment in GEM OS1 US Pivotal Trial FRANKLIN, Tenn. -- BioMimetic Therapeutics, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :BMTI BMTI Block Mode Terminal Interface ) today reported its financial results as of and for the three and twelve months ended December 31, 2006. For the three months ended December 31, 2006, the Company reported a net loss of $5.3 million or $(0.34) per share, compared to a net loss of $9.2 million, or $(5.82) per share, for the same period in 2005. For the full year, the Company reported a net loss of $17.2 million, or $(1.62) per share, compared to a net loss of $12.0 million, or $(7.59) per share, for 2005. The Company ended the year in a strong financial position, with $48.1 million of cash and cash equivalents. In February 2007, the Company completed a secondary public offering which provided net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of an additional $40.0 million of cash. Today the Company also announced that it received clearance from the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to initiate enrollment in its US pivotal trial with GEM OS([R])1 for foot and ankle fusions. The randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. controlled US pivotal trial is expected to include enrollment of up to 280 patients. The study's objective is to determine the safety and effectiveness of GEM OS1 for bone regeneration in foot and ankle fusion procedures requiring open surgery. The Company previously reported data from US and Canadian clinical trials which demonstrated that fusion rates for GEM OS1 treated patients appeared to be at least comparable to patients treated with autograft autograft: see transplantation, medical. . Autograft is bone harvested from elsewhere in the patient's own body and is currently considered the standard of care for bone grafting Bone Grafting Definition Bone grafting is a surgical procedure by which new bone or a replacement material is placed into spaces between or around broken bone (fractures) or holes in bone (defects) to aid in healing. materials, despite having several limitations including increased pain for the patient and increased procedure time for the surgeon. Recent Company Highlights During 2006 and the first part of 2007, the Company made significant advancements in its product development programs and other critical business areas: GEM OS1 & GEM OS([R])2: * Completed enrollment in three pilot clinical studies with lead orthopedic product candidate GEM OS1 Bone Graft bone graft Orthopedic surgery Sterilized bony tissue, often of cadaveric origin, used to fill and/or 'sculpt' bone defects Indications Spinal fusion, revision of failed articular prostheses, filling traumatic or malignant bone defects, or periodontal defects. for the treatment of foot and ankle fusions (US and Canadian studies Canadian Studies is a Collegiate study of Canadian culture, Canadian languages, literature, Quebec, agriculture, history, and their government and politics. Most universities recommend that students take a double major (i.e. ) and distal radius fractures (Swedish study). Expanded the Canadian study from the original 20 patients to 60 patients, providing the potential to file for product registration in Canada in 2007. * Reported interim results as presented by lead Canadian investigator, Timothy R. Daniels, M.D., suggesting that treatment with GEM OS1 for foot and ankle fusion indications is comparable to autograft, without the pain and morbidity associated with harvesting the autograft from patients. * Reported interim results of the randomized US pilot study on foot and ankle fusions comparing GEM OS1 to autograft indicating that patients treated with GEM OS1 had results comparable to patients treated with autograft. * Reported preliminary results from the Swedish distal radius fracture pilot study demonstrating accelerated bone regeneration at earlier time points in patients treated with GEM OS1 combined with external fixation external fixation n. The fixation of a fractured bone by a splint or plastic dressing. external fixation Orthopedics Open reduction, stabilization and use of external fixators to manage fracture bone fragments compared to patients treated with external fixation alone. * Initiated a clinical study in Sweden to evaluate GEM OS2 Injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. Bone Graft for the treatment of distal radius fractures using percutaneous administration of the product candidate into the fracture site. * Received clearance from the FDA to initiate patient enrollment in the US pivotal trial to compare GEM OS1 to autograft in foot and ankle fusions. The Company expects to initiate patient enrollment in April 2007 and is concurrently working to address questions raised by the FDA in its clearance. GEM 21S[R]: * Received market approval from Health Canada for GEM 21S Growth-factor Enhanced Matrix for the treatment of periodontally-related bone defects and gingival gingival (jin´j * Obtained removal of all post-marketing restrictions on use of certain rhPDGF-BB produced by Novartis (Chiron) for inclusion in the Company's GEM 21S product. * Presented results at the American Academy of Periodontology American Academy of Periodontology (AAP), n.pr a nonprofit professional association of dental professionals specializing in the prevention, diagnosis, and treatment of diseases affecting the periodontium and in the placement and maintenance of dental implants. Annual Meeting demonstrating continued long-term efficacy up to 24 months after treatment with GEM 21S. Other: * Received orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation from the FDA for the use of rhPDGF-BB for the treatment of Osteonecrosis of the Jaw Osteonecrosis of the jaws (ONj) is a severe bone disease that affects the jaws, including the maxilla and the mandible. Jaw bone (osteo-) damage and death (-necrosis) occurs as a result of reduced local blood supply (ischaemia). (ONJ ONJ Osteonecrosis of the Jaw ONJ Olivia Newton-John ONJ Orchestre National de Jazz (France) ONJ Odate Noshiro Airport (Akita, Japan airport code) ONJ Observatoire National de la Jeunesse ). * Completed initial public offering in May 2006, selling 4.6 million shares of common stock with net proceeds of $32 million. * Completed secondary public offering in February 2007, selling 2.5 million primary shares of common stock with net proceeds of $40 million. "We have made significant advancements over the past year in our product development and finance activities," said Dr. Samuel E. Lynch, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of BioMimetic Therapeutics. "GEM 21S continues to be well received by dental surgeons and has laid the ground work for our significant progress in our orthopedic and sports medicine sports medicine, branch of medicine concerned with physical fitness and with the treatment and prevention of injuries and other disorders related to sports. Knee, leg, back, and shoulder injuries; stiffness and pain in joints; tendinitis; "tennis elbow"; and programs. The data from all three of our initial clinical trials in orthopedic indications were positive, showing increased bone regeneration with GEM OS1 treatment. We expect to begin patient enrollment in our US pivotal clinical trial in foot and ankle fusions with GEM OS1 within the next few weeks. Moreover, as evidenced by initiation of our clinical trial on GEM OS2 Injectable Bone Graft for treatment of closed fractures, we are concurrently advancing our pipeline of recombinant protein recombinant protein Molecular biology A protein encoded by recombinant DNA or generated from a recombinant gene. See Recombinant pharmacology. based therapeutic product candidates for multiple orthopedic indications." Additional Financial Results For the three months ended December 31, 2006, the Company reported revenues of $1.9 million, which includes $1.4 million of product sales of GEM 21S to its marketing partner Osteohealth Company (a division of Luitpold Pharmaceuticals, Inc., which is a group company of Daiichi-Sankyo, Inc.) and $0.2 million of sublicense fee income. This compares to revenues of $0.6 million for the three months ended December 31, 2005. For the twelve months ended December 31, 2006, total revenues were $4.1 million, including $2.6 million of product revenue from the sale of GEM 21S to Osteohealth, compared to total revenue of $4.5 million for the twelve months ended December 31, 2005. The decrease in 2006 revenue can be attributed to the recognition in 2005 of $4.3 million of collaborative research and development revenue and milestone payments, all of which were paid by the Company's marketing partner to compensate the Company for the cost of research and development related to FDA approval of the Company's periodontal periodontal /peri·odon·tal/ (per?e-o-don´t'l) 1. pertaining to the periodontal ligament or periodontium. 2. near or around a tooth. per·i·o·don·tal adj. 1. product. During the twelve months ended December 31, 2006, the Company recognized collaborative research and development revenue of $0.2 million. Research and development expenses totaled $3.9 million for the three months ended December 31, 2006, compared to $8.0 million for the three months ended December 31, 2005. Research and development expenses primarily relate to activities associated with pilot clinical trials for GEM OS1, as well as continuing expenses associated with pursuing GEM 21S marketing approval in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community , and included a one time supplier milestone expense of $5.0 million in 2005. For the twelve months ended December 31, 2006, research and development expenses were $11.7 million compared to $12.6 million for the twelve months ended December 31, 2005. General and administrative expenses were $2.0 million for the three months ended December 31, 2006, compared to $1.4 million for the three months ended December 31, 2005. For the twelve months ended December 31, 2006, general and administrative expenses totaled $6.5 million compared to $3.4 million for the twelve months ended December 31, 2005. The increase in 2006 general and administrative expenses was primarily attributable to an increase in salaries and wages, professional fees, costs of operating as a public company, stock based compensation expenses and facilities costs. Facilities costs are primarily comprised of rent, utilities, and common area maintenance. 2007 Financial Guidance The Company ended 2006 with approximately $48.1 million of cash and cash equivalents. Based on current operating plans, expected timing and cost of clinical trials and other product development programs, the Company expects its 2007 year-end cash balance to range from $74 to $78 million, or an annual net cash burn of $10 to $14 million, including $15 million in additional milestone payments that the Company expects to receive in the fourth quarter of 2007 from its GEM 21S marketing partner. Total product revenue for the year ending December 31, 2007 is projected to be approximately $5.0 million, excluding milestone and royalty payments, with a year-end net loss attributable to common shareholders to range from $24 to $28 million. Conference Call and Webcast As previously announced, BioMimetic will be hosting a conference call and webcast today, March 28, 2007, at 4:30 p.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT to discuss the 2006 fourth quarter and year-end financial results. A live webcast of the conference call will be available on the Investor Relations Investor relations The process by which the corporation communicates with its investors. section of BioMimetic's website at www.biomimetics bi·o·mi·met·ics n. (used with a sing. verb) The study of the structure and function of biological systems as models for the design and engineering of materials. .com. The webcast will be archived on the website for at least 30 days. The conference call can be accessed by dialing 800-299-7928 (passcode 12523233). The international dial in number is 617-614-3926. The same passcode applies. Participants should dial in 10 minutes prior to the call. About BioMimetic Therapeutics BioMimetic Therapeutics, Inc. is developing and commercializing bio-active recombinant protein-device combination products for the healing of musculoskeletal musculoskeletal /mus·cu·lo·skel·e·tal/ (-skel´e-t'l) pertaining to or comprising the skeleton and muscles. mus·cu·lo·skel·e·tal adj. Relating to or involving the muscles and the skeleton. injuries and disease, including periodontal, orthopedic, spine and sports injury sports injury A injury sustained practicing or competing in a sport Sites Thigh, foot, knee, lower leg, ankle, hip, finger Types Contusion, strain, sprain, heat exhaustion, lacerations, etc Sports with most Martial arts–judo, tae kwon do, wrestling, applications. BioMimetic received marketing approval from the FDA for its first product, GEM 21S([R]), as a grafting material for bone and periodontal regeneration following completion of human clinical trials, which demonstrated the safety and efficacy of its platform technology in this indication. Additionally, the Company has clinical trials ongoing with its product candidate GEM OS[R]1 in multiple orthopedic bone healing indications including the treatment of foot and ankle fusions and the stimulation of healing of fractures of the arm. The Company's product and lead product candidates all combine recombinant protein therapeutics with tissue specific scaffolds to actively stimulate tissue healing and regeneration. Forward-looking Statements This press release contains "forward-looking statements" within the meaning of 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. These forward-looking statements are based on the current intent and expectations of the management of BioMimetic. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. There are many important factors that could cause actual results to differ materially from those indicated in the forward-looking statements. BioMimetic's actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with the marketing of BioMimetic's product and product candidates, unproven preclinical and clinical development activities, regulatory oversight, and other risks detailed in the company's filings with the Securities and Exchange Commission. Except as required by law, BioMimetic undertakes no responsibility for updating the information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise, or for changes made to this document by wire services or Internet services. For further information, visit www.biomimetics.com or contact Kearstin Patterson, corporate communications, at 615-236-4419. [TABLE OMITTED] [TABLE OMITTED] |
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