- 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.
For the three months ended March 31, 2012, the Company reported total revenues of $0.5 million consisting of sublicense fee income, royalty income and product sales. This compares to total revenues of $0.4 million recorded for the same period in 2011.Research and development expenses totaled $2.8 million for the three months ended March 31, 2012, compared to $4.1 million for the same period in 2011. Research and development expenses include outside professional services expenses, as well as salaries, wages, benefits, payroll taxes and stock-based compensation expense for internal research and development personnel, and relate to clinical trials of our product candidates in the United States, Canada, Australia and the European Union, as well as continuing expenses associated with pre-clinical studies and regulatory filings. The 2012 expenses for professional services and manufacturing activities decreased by $0.5 million, as costs associated with the Company’s Augment Injectable clinical trial have decreased since the Company voluntarily suspended additional screening and enrollment of patients to conserve resources and focus its attention on addressing the Augment PMA. Salaries, benefits, payroll taxes and stock-based compensation expense in the research and development function decreased in 2012 by a combined $0.7 million due to a reduction in staffing. In addition, expenses for general business activities in the research and development function, such as travel, recruiting and relocation, lab supplies, and freight, decreased in 2012 by $0.1 million. Selling, general and administrative expenses totaled $3.4 million for the three months ended March 31, 2012, compared to $4.0 million for the same period in 2011. The 2012 expenses for selling, general and administrative activities decreased primarily from the Company’s efforts to carefully manage expenses and conserve resources given the uncertainty surrounding the FDA review process of its PMA application for Augment, offset partially by the Company’s sales, marketing and customer service efforts, particularly in connection with activities surrounding the preparation for commercial launch of Augment and Augmatrix. Expenses for professional services decreased in 2012 by $0.4 million, and expenses for general business activities in the selling, general and administrative function, such as travel, conferences and seminars, recruiting and relocation, dues and subscriptions, office supplies, rent and utilities, decreased in 2012 by $0.2 million.
2012 Financial GuidanceBased on current operating plans, forecasted timing and costs of clinical trials and other product development programs, the Company anticipates its 2012 year-end balance of cash, cash equivalents and investments to range from $32 to $39 million, and anticipates its net cash use will be between $22 and $29 million. Net loss for the year ending December 31, 2012 is forecasted to be in the range of $23 to $30 million. Conference Call and Webcast As previously announced, BioMimetic will be hosting a conference call and webcast on Wednesday, May 9, 2012 at 4:30 p.m. EDT to discuss the first quarter financial results. A live webcast of the conference call will be available on the Investor Relations section of BioMimetic’s website at www.biomimetics.com. The webcast will be archived on the website for at least 30 days. The conference call may be accessed on May 9, 2012 by dialing (877) 224 - 4059 for U.S. and Canadian callers (passcode: 78229094). The international dial in number is (706) 902 - 2069, and the same passcode applies. Participants should dial in 10 minutes prior to the call. About BioMimetic Therapeutics BioMimetic Therapeutics (NASDAQ: BMTI) is a biotechnology company specializing in the development and commercialization of clinically proven products to promote the healing of musculoskeletal injuries and diseases, including therapies for orthopedics, sports medicine and spine applications. All Augment ® branded products are based upon recombinant human platelet-derived growth factor (rhPDGF-BB), which is an engineered form of PDGF, one of the body's principal agents to stimulate and direct healing and regeneration. Through the commercialization of this patented technology, BioMimetic seeks to become the leading company in the field of regenerative medicine by providing new treatment options for the repair of bone, cartilage, tendons and ligaments. BioMimetic has received regulatory approvals to market Augment ® Bone Graft in Canada, Australia and New Zealand for use in hindfoot and ankle fusion indications. Augment is pending regulatory decisions in the U.S. and European Union for similar indications. The Company also markets a bone graft substitute line of products for orthopedic indications called Augmatrix™ Biocomposite Bone Graft. For further information contact Kearstin Patterson, senior director of corporate communications, at 615-236-4419.
Forward-looking StatementsThis press release contains forward-looking statements about our future results of operations and financial position, product development programs, business strategy, budgets, projected costs, plans and objectives of management for future operations that are not historical facts. The words “may,” “continue,” “estimate,” “intend,” “plan,” “will,” “believe,” “project,” “expect,” “anticipate,” “optimistic” and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. There are many important factors that could cause actual results to differ materially from those indicated in the forward-looking statements, including factors related to: (i) the FDA may not be satisfied with the Company’s amendment to its PMA and may determine such PMA is not approvable or require additional clinical trials; (ii) despite the Company’s future marketing and commercialization efforts, Augment and Augmatrix may not achieve broad market acceptance; and (iii) the EU regulatory authorities may determine that the CE Mark for GEM 21S was improperly granted and may not approve the CE Mark for Augment as a medical device. Further, 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 detailed in BioMimetic’s recent annual and quarterly reports filed with the Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2012, which are incorporated in this press release by this reference. 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, and has no policy of doing so.
|BIOMIMETIC THERAPEUTICS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$||20,448,444||$||18,503,061|
|Investments - short term||34,060,487||42,950,397|
|Receivables - trade, net||88,472||85,759|
|Receivables - other||470,372||1,121,596|
|Total current assets||59,012,162||66,674,969|
|Receivables - long term||73,664||73,801|
|Prepaid expenses - long term||3,197||4,577|
|Property and equipment, net||4,948,982||5,304,565|
|Capitalized patent license fees, net||2,517,089||2,443,590|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued payroll, employee benefits and payroll taxes||1,626,784||2,430,701|
|Other accrued expenses||599,165||634,216|
|Current portion of capital lease obligations||87,827||83,921|
|Total current liabilities||4,026,268||6,515,597|
|Accrued rent - related party||630,110||622,950|
|Capital lease obligations||110,472||131,724|
|Preferred stock, $0.001 par value; 15,000,000 shares authorized; no shares issued and outstanding as of March 31, 2012 and December 31, 2011||-||-|
|Common stock, $0.001 par value; 100,000,000 shares authorized; 28,199,501 shares issued and outstanding as of March 31, 2012; 28,128,280 shares issued and outstanding as of December 31, 2011||28,200||28,128|
|Additional paid-in capital||215,535,331||214,626,320|
|Accumulated other comprehensive loss||9,808||4,490|
|Total stockholders’ equity||48,808,735||54,011,590|
|Total liabilities and stockholders’ equity||$||66,940,094||$||74,886,502|
|BIOMIMETIC THERAPEUTICS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME|
|Three months ended|
|Sublicense fee income||242,132||239,471|
|Costs and expenses:|
|Cost of sales (exclusive of depreciation and amortization shown separately below)||15,468||12,698|
|Research and development||2,767,624||4,084,832|
|Selling, general and administrative||3,448,038||4,022,257|
|Depreciation and capital lease amortization||364,916||264,248|
|Patent license fee amortization||10,503||8,058|
|Total costs and expenses||6,606,549||8,392,093|
|Loss from operations||(6,140,171||)||(7,993,408||)|
|Interest expense, net||(714||)||(615||)|
|Investment income, net||22,638||39,677|
|Gain on foreign currency translation and other transactions||991||1,032|
|Loss before income taxes||(6,117,256||)||(7,953,314||)|
|Basic and diluted net loss per share||$||(0.22||)||$||(0.28||)|
|Weighted average shares used to compute basic and diluted net loss per share||28,145,241||27,931,388|