BioMimetic Therapeutics, Inc. reported its financial results as of and for the three and nine months ended September 30, 2010. For the three months ended September 30, 2010, the Company reported a net loss of $7.8 million, or $0.29 per diluted share, compared to a net loss of $7.9 million, or $0.36 per diluted share, for the same period in 2009. For the nine months ended September 30, 2010, the Company reported a net loss of $23.9 million, or $1.02 per diluted share, compared to a net loss of $22.3 million, or $1.11 per diluted share, for the same period in 2009. The Company ended the quarter with $99.4 million of cash and cash equivalents and investments.
“We remain focused on obtaining marketing approval and preparing for the anticipated commercial launch of Augment Bone Graft in the United States and other parts of the world. We believe we remain on track for a FDA Advisory Panel meeting in early 2011, and approval shortly thereafter,” said Samuel Lynch, president and CEO of BioMimetic Therapeutics. “Successfully meeting these objectives will help position us as a premier high growth orthobiologics company in the musculoskeletal space.”
Recent Product Development and Corporate Highlights
During the third quarter of 2010, the Company made advancements in its product development programs and other critical business areas:
Augment™ Bone Graft
In September 2010, the Company announced that it completed its 100-day Premarket Approval (PMA) application meeting with the Food & Drug Administration (FDA) regarding the review of Augment for the treatment of foot and ankle fusions in the United States. To date, the FDA has raised no unexpected issues that would impact the timing for an upcoming Orthopedic Advisory Panel meeting or potential approval of Augment. The Company anticipates that the panel meeting will be held in early 2011. If the panel determines the product to be safe and effective and if the FDA finds the PMA information satisfactory, the Company expects approval of Augment will occur within six months after the panel meeting.
The Company remains focused on preparing for the commercialization of Augment. During the third quarter, the Company completed a detailed analysis of commercialization infrastructure required for the U.S. launch of Augment and began to implement the necessary systems and capabilities. In Canada, seventeen institutions have either used or have approved the use of Augment, and the Company remains on track to meet the goal of 20 to 25 unique institutions approved to use the product by year-end. In addition, the Company is changing its distribution strategy in Canada and is currently transitioning from a single exclusive distributor to a network of independent sales agents who will be more closely managed by the Company’s Canadian national sales manager. Currently, the Company anticipates it will have approximately 25 sales representatives covering all of Canada by the end of 2010.
Augment Injectable™ Bone Graft
In September 2010, the Company received a determination letter from the FDA regarding its request for designation (RFD) for Augment Injectable Bone Graft, the Company’s second generation bone grafting product. The letter indicated that Augment Injectable review will follow a medical device pathway, and the Company’s previously filed Investigational Device Exemptions (IDE) for the use of Augment Injectable in treating foot and ankle fusions continues to be assigned to the FDA’s Center for Devices and Radiologic Health’s (CDRH), Division of Surgical, Orthopedic and Restorative Devices for lead review. The device will be reviewed through the premarket approval process to confirm reasonable assurance of safety and effectiveness. The Company expects to initiate patient enrollment in a U.S. pivotal trial shortly after the anticipated FDA approval of the IDE. IDE approval is expected to occur around year-end 2010.
About BioMimetic Therapeutics
BioMimetic Therapeutics (NASDAQ: BMTI) is a biotechnology company utilizing purified recombinant human platelet-derived growth factor (rhPDGF-BB) in combination with tissue specific matrices as its primary technology platform for promotion of tissue healing and regeneration. rhPDGF-BB is a synthetic form of one of the body’s principal agents to stimulate and direct healing and regeneration. The mechanism of action of this platform technology suggests it may be effective in a broad array of musculoskeletal applications, including the repair of bone, ligament, tendon and cartilage. Through the commercialization of this technology, BioMimetic seeks to become the leading company in the field of orthopedic regenerative medicine.
In 2005, BioMimetic received marketing approval from the FDA for its first product, GEM 21S®, as a grafting material for bone and periodontal regeneration. Additionally, BioMimetic Therapeutics has completed and continues to sponsor clinical trials with its two lead product candidates Augment™ Bone Graft and Augment™ Injectable Bone Graft in multiple orthopedic bone healing indications including the treatment of foot and ankle fusions and the stimulation of healing of fractures of the wrist. In November 2009, BioMimetic received approval from Health Canada to begin marketing Augment as an alternative to the use of autograft, the current gold standard in bone grafting, in foot and ankle fusion indications in Canada. In May 2010, the Company’s Pre-Marketing Approval (PMA) application for the approval of Augment Bone Graft was filed with the FDA, and the Company anticipates approval for this product in the United States in 2011.
GEM 21S is a trademark of Luitpold Pharmaceuticals, Inc., who now owns this dental related product and markets it through its Osteohealth Company in the United States and Canada.