BioMimetic Therapeutics Reports 2007 First Quarter Results.Company Added to NASDAQ Biotechnology Index The NASDAQ Biotechnology Index includes securities of NASDAQ-listed companies classified according to the Industry Classification Benchmark as either Biotechnology or Pharmaceuticals which also meet other eligibility criteria. 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 for the three months ended March 31, 2007. For this quarter, the Company reported a net loss of $5.7 million or $(0.34) per share, compared to a net loss of $3.8 million, or $(2.22) per share, for the same period in 2006. The Company ended the quarter in a strong financial position with $84.2 million of cash, cash equivalents and investments in 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 . Additionally, NASDAQ announced on Friday May 11, 2007 that BioMimetic Therapeutics has been selected for addition to the NASDAQ Biotechnology Index, which will be effective at the market's open on Monday, May 21, 2007. The NASDAQ Biotechnology Index was launched in 1993 and includes securities of NASDAQ-listed companies that meet certain requirements, including market value, average daily share volume, and seasoning as a public company, among other criteria. The index is ranked on a semi-annual basis in May and November and serves as the basis for the iShares NASDAQ Biotechnology Index Fund (Amex: IBB IBB International Broadcasting Bureau (US government) IBB Institute of Biochemistry and Biophysics IBB Islamic Bank of Britain IBB I'll Be Back IBB Intentional Base on Balls ). For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit www.nasdaq.com. The Company also announced today that Dr. Russ Pagano will be joining the Company effective May 23, 2007 in the position of vice president of regulatory and clinical affairs. Dr. Pagano received his Ph.D. from Duke University and joined the US 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. ") as a scientific reviewer in the Office of Device Evaluation in 1994. He served as FDA chief of the Restorative Devices Branch, which included a portion of the organization's orthopedic products from 1997 to 2000 and FDA chief of the Pacing, Defibrillators and Leads Branch from October 2000 to May 2001. Since that time, he has been executive vice president and regulatory advisor at M Squared Associates, a consulting firm in Washington D.C. In that capacity, Dr. Pagano has served as a regulatory consultant to BioMimetic and numerous other companies. Dr. Pagano will take over responsibilities for regulatory affairs from Mr. Mark Citron citron (sĭt`rən), name for a tree (Citrus medica) of the family Rutaceae (orange family), and for its fruit, the earliest of the citrus fruits to be introduced to Europe from Asia. who previously announced that he is resigning from the Company effective May 29, 2007. "We are pleased with the advancements we've made in our orthopedic programs during the first part of 2007," 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. "We initiated patient enrollment in a U.S. pivotal study assessing the safety and efficacy of GEM OS1 in foot and ankle fusions and remain on track to file for product registration for GEM OS1 in Canada by the end of this year. Additionally, we have moved our second orthopedic product candidate, GEM OS2, into clinical studies. GEM OS2, which allows for a minimally invasive, percutaneous delivery technique, has the potential to open up entirely new markets for the Company. We also feel very privileged to be included in the NASDAQ Biotechnology Index." Recent Company Highlights During the first part of 2007, the Company made significant advancements in its product development programs and other critical business areas: * Reported preliminary results from the Swedish distal radius fracture Distal radius fractures are a very common injury of the radius that occur at the distal end, where the wrist joint lies. Definition A fracture affecting the distal end of the radius and often the ulnar styloid. pilot clinical study indicating faster bone healing at the fracture site as measured by CT scans in patients treated with GEM OS[R]1 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. 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. * Received clearance from the FDA and initiated patient enrollment in a U.S. pivotal trial to compare GEM OS1 to autograft autograft: see transplantation, medical. for the treatment of foot and ankle fusions. * Initiated a pilot clinical study in Sweden to evaluate GEM OS[R]2 Injectable Bone Graft for the treatment of distal radius fractures using minimally invasive administration of the product candidate into the fracture site. * 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 the 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 ). * Selected for addition to the NASDAQ Biotechnology Index effective May 21, 2007. * Completed secondary public offering in February 2007, selling approximately 2.5 million primary shares of common stock with 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). to the Company of approximately $39.8 million. * Hired Dr. Russ Pagano as vice president of regulatory and clinical affairs effective May 23, 2007. Additional Financial Results For the three months ended March 31, 2007, the Company reported total revenues of $0.4 million, which includes approximately $25,000 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.), $0.2 million of sublicense fee income and $0.2 million of royalty income. This compares to total revenues of $0.4 million for the three months ended March 31, 2006. Research and development expenses totaled $3.9 million for the three months ended March 31, 2007, compared to $2.5 million for the three months ended March 31, 2006. Research and development expenses primarily relate to activities associated with clinical trials and related employee costs, 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 . General and administrative expenses were $2.0 million for the three months ended March 31, 2007, compared to $1.1 million for the three months ended March 31, 2006. The increase in first quarter 2007 general and administrative expenses was primarily attributable to an increase in salaries and wages, professional services, costs of operating as a public company and facilities costs. Facilities costs are primarily comprised of rent, utilities, and common area maintenance. 2007 Financial Guidance 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 $64 to $68 million, or an annual net cash burn of $20 to $24 million, including $5 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 of $24 to $28 million. Conference Call and Webcast As previously announced, BioMimetic will be hosting a conference call and webcast today, May 14, 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 2007 first quarter 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 800-638-5439 (passcode 78501559). The international dial in number is 617-614-3945. 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 orthopedic, periodontal, spine and sports injury 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 candidates GEM OS([R])1 and GEM OS([R])2 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 approval, 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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