, Inc. (NASDAQ: BMTI) today reported its corporate highlights and financial results as of and for the three months ended March 31, 2012. For the three months ended March 31, 2012, the Company reported a net loss of $6.1 million, or $0.22 per diluted share, compared to a net loss of $8.0 million, or $0.28 per diluted share, for the same period in 2011. The Company ended the quarter with $54.5 million of cash and cash equivalents and investments.
Corporate Development Highlights
The following were some of the key Company highlights during the first quarter of 2012:
- In January 2012, the Company announced receipt of a comprehensive post-panel response letter from the FDA related to the Pre-Market Approval (PMA) application for Augment® Bone Graft. The letter detailed the information the Company needs to submit for the FDA to complete its review of the Company’s PMA application. The Company continues to work toward completion of the requested additional analyses and expects to submit the information in the form of an amendment to its PMA application by the middle of 2012. Although the timing and nature of the FDA’s response cannot be predicted with certainty, by statute the FDA has six months from the date of submission to respond to a PMA amendment.
- The Company is also pursuing regulatory approvals for Augment Bone Graft in several OUS (outside U.S.) markets. In addition, the Company is awaiting reimbursement decisions in Australia and New Zealand where Augment has already received approval.
- In April, the Company shipped its first orders of Augmatrix™ Biocomposite Bone Graft to its distributors who have begun the process of getting Augmatrix stocked in hospitals and surgical centers, while educating surgeons on the attributes of the product line. Augmatrix is a family of grafting materials that has been FDA cleared for use in orthopedic indications for which Augment will not initially be indicated. Augmatrix is comprised of carbonate-apatite and bovine Type I collagen and is designed to be combined with bone marrow aspirate (BMA).
- The Company continues to work with European Union (EU) regulatory authorities toward a final CE Mark decision for GEM 21S ®. Luitpold Pharmaceuticals, a subsidiary of Daiichi Sankyo, Inc., which bought the rights to the dental and cranio-maxillofacial applications for BioMimetic’s rhPDGF-BB technology, has notified the Company that it is evaluating whether the conditions for the $10M milestone payment it owes the Company upon approval of GEM 21S in the EU have been satisfied. Earlier this year, at the request of Luitpold, the EU regulatory authorities indicated they would be re-evaluating the CE Mark recently granted for the product to determine if the product was properly classified as a medical device rather than a medicinal. The Company is considering its options in the event Luitpold does not make the payment.
- The Annual Meeting of Stockholders has been scheduled for Thursday, June 7, 2012, at 8:00 a.m. CDT at the Company’s corporate headquarters south of Nashville, Tennessee. The holders of the Company’s common stock of record at the close of business on April 12, 2012 are entitled to vote at the annual meeting.
“We continue to be focused on gaining FDA marketing approval of Augment. Accordingly, we remain on schedule to complete collecting, analyzing and reporting the additional information the FDA has requested by mid-year,” said Dr.
, president and CEO of
. “We are gratified by the ongoing support of the surgeons who have used the product, and we anticipate that substantial additional clinical information relating to the Augment family of products will be presented at the American Orthopedic Foot and Ankle Society annual summer meeting in June.”
Additional Financial Results
As of March 31, 2012, the Company had approximately $20.4 million in cash and cash equivalents and $34.1 million in short-term investments.