BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today reported its financial results as of and for the three and twelve months ended December 31, 2011. For the three months ended December 31, 2011, the Company reported a net loss of $9.9 million, or $0.35 per diluted share, compared to a net loss of $10.0 million, or $0.36 per diluted share, for the same period in 2010. For the twelve months ended December 31, 2011, the Company reported a net loss of $33.2 million, or $1.19 per diluted share, compared to a net loss of $33.9 million, or $1.38 per diluted share, for the same period in 2010. The Company ended the year with $61.5 million of cash and cash equivalents and investments.
Recent and 2011 Product and Corporate Development Highlights
The Company made the following advancements in its product development programs and other critical business areas:
Augment® Bone Graft PMA Updates
“We continue to believe in the safety and effectiveness of Augment and remain optimistic about obtaining FDA approval of the product candidate,” said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. “The Company is diligently working through the action items listed in the post-panel letter, and we expect to have the PMA amendment submitted by the middle of 2012.”
Other Product Development Updates
“The submission of the PMA amendment for Augment remains our highest priority,” continued Dr. Lynch. “Additionally, we are preparing for entry into the large U.S. bone graft market with the launch of Augment outside the U.S. as well as the launch of Augmatrix in the U.S., and we continue to work towards additional marketing approvals for these products worldwide.”
Additional Financial Results
As of December 31, 2011, the Company had approximately $61.5 million in cash, equivalents and investments.
The net loss for the twelve months ended December 31, 2011 was $33.2 million, or $1.19 per diluted share, and included an impairment loss on equipment of $2.9 million. Excluding the impairment loss on equipment, the Company’s net loss for the twelve months ended December 31, 2011 would have been $30.3 million, or $1.08 per diluted share. Comparatively, the net loss for the same period in 2010 was $33.9 million, or $1.38 per diluted share.
For the three and twelve months ended December 31, 2011, the Company reported total revenues of $0.5 million and $1.7 million, respectively, consisting of product sales, royalty income and sublicense fee income. This compares to total revenues of $0.4 million and $1.5 million, respectively, recorded for the three and twelve months ended December 31, 2010.
Research and development expenses totaled $3.2 million for the three months ended December 31, 2011, compared to $5.4 million for the same period in 2010. For the twelve months ended December 31, 2011, research and development expenses totaled $14.7 million, compared to $18.0 million for the same period in 2010. Research and development expenses include outside professional services expenses, as well as salaries, wages and related benefits, payroll taxes and stock compensation expense, and result primarily from clinical trials of the Company’s orthopedic product candidates in the United States, Canada and the European Union, as well as continuing expenses associated with new and ongoing pre-clinical studies and regulatory filings. The 2011 expenses for professional services and manufacturing costs associated with clinical trials, which decreased by a combined $2.0 million for the twelve months ended December 31, 2011, were lower primarily due to the completion of the Augment foot and ankle clinical trials in the United States in 2010, and offset slightly by the Augment Injectable and Augment Rotator Cuff Graft clinical trials in Canada in 2011. Salaries, benefits, payroll taxes and stock compensation expense in the research and development function decreased in 2011 by a combined $1.0 million due to a reduction in staffing. In addition, expenses for general business activities in the research and development function, such as travel, insurance, lab supplies and telephone, decreased in 2011 by $0.3 million.
General and administrative expenses totaled $3.8 million for the three months ended December 31, 2011, compared to $5.2 million for the same period in 2010. For the twelve months ended December 31, 2011, general and administrative expenses totaled $16.0 million, compared to $15.2 million for the same period in 2010. The increase in general and administrative expenses for the twelve months ended December 31, 2011 resulted primarily from an increase of $0.8 million in salaries, benefits, payroll taxes, stock-based compensation expense, travel and advertising (primarily driven by the sales department’s net increase of five employees and its efforts to establish a sales network in anticipation of product commercialization), an increase of $0.4 million in rent and utilities, and a decrease of $0.4 million in royalty expense.
2012 Financial Guidance
Based 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 Tuesday, March 13, 2012 at 4:30 p.m. EDT to discuss the fourth quarter and year-end 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 March 13, 2012 by dialing (877) 224-4059 for U.S. and Canadian callers. The pass code for the call is 57985649. The international dial in number is (706) 902-2069 and the same pass code 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 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 AugmatrixTM Biocomposite Bone Graft.
For further information contact Kearstin Patterson, director of corporate communications, at 615-236-4419.
This 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) the Augment Rotator Cuff pilot clinical results may not be representative of results that may be achieved in a larger study; (iii) despite the Company’s future marketing and commercialization efforts, Augment and Augmatrix may not achieve broad market acceptance; and (iv) 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 Quarterly Report on Form 10-Q, filed with the SEC on November 8, 2011, 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.|
|CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||18,503,061||$||11,628,329|
|Investments - short term||42,950,397||65,751,039|
|Receivables - trade||85,759||8,050|
|Receivables - other||1,121,596||468,380|
|Total current assets||66,674,969||80,702,054|
|Investments - long term||-||15,001,765|
|Receivables - long term||73,801||-|
|Prepaid expenses - long term||4,577||5,252|
|Property and equipment, net||5,304,565||7,592,820|
|Capitalized patent license fees, net||2,443,590||1,867,937|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued payroll, employee benefits and payroll taxes||2,430,701||2,590,126|
|Other accrued expenses||634,216||1,908,680|
|Current portion of capital lease obligations||83,921||78,665|
|Total current liabilities||6,515,597||7,219,489|
|Accrued rent - related party||622,950||419,465|
|Capital lease obligations||131,724||215,644|
Preferred stock, $0.001 par value; 15,000,000 shares authorized; no shares issued and outstanding as of December 31, 2011 and 2010
Common stock, $0.001 par value; 100,000,000 shares authorized and 28,128,280 shares issued and outstanding as of December 31, 2011; 37,500,000 shares authorized and 27,925,984 shares issued and
|outstanding as of December 31, 2010|
|Additional paid-in capital||214,626,320||210,553,647|
|Accumulated other comprehensive income||4,490||(2,462||)|
|Total stockholders’ equity||54,011,590||83,121,740|
|Total liabilities and stockholders’ equity||$||74,886,502||$||105,554,828|
|BIOMIMETIC THERAPEUTICS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three months ended||Twelve months ended|
|December 31,||December 31,|
|Sublicense fee income||244,792||244,792||971,188||971,188|
|Costs and expenses:|
Cost of sales (exclusive of depreciation and amortization shown separately below)
|Research and development||3,241,574||5,417,040||14,694,803||17,966,916|
|General and administrative||3,772,894||5,192,214||16,033,714||15,160,468|
|Depreciation and capital lease amortization||362,570||291,568||1,256,552||1,234,335|
|Patent license fee amortization||9,558||18,386||36,793||1,658,104|
|Total costs and expenses||7,405,831||10,936,458||32,075,293||36,037,073|
|Loss from operations||(6,947,478||)||(10,542,965||)||(30,350,347||)||(34,563,548||)|
|Interest expense, net||(925||)||(656||)||(4,321||)||(3,602||)|
|Investment income, net||21,289||46,197||112,859||143,720|
|Impairment loss on equipment||(2,939,601||)||-||(2,939,601||)||-|
|Other income from governmental grants||-||488,959||-||513,959|
|Loss on foreign currency translation and other||(6,512||)||-||(8,567||)||(27,680||)|
|Loss before income taxes||(9,873,227||)||(10,008,465||)||(33,189,977||)||(33,937,151||)|
|Basic and diluted net loss per share||$||(0.35||)||$||(0.36||)||$||(1.19||)||$||(1.38||)|
Weighted average shares used to compute basic and diluted net loss per share