LYNBROOK, N.Y., March 12, 2013 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S., today announced its financial results for the fourth quarter and full year ended December 31, 2012 and provided a corporate update.
"We are looking forward to the potential FDA approval of XIAFLEX for the treatment of Peyronie's disease followed by the anticipated commercial launch in the fourth quarter of this year, and believe in the strong commercial opportunity for XIAFLEX for this devastating disease," reflected Thomas L. Wegman, President of BioSpecifics. "We are also very pleased to announce today that we have completed enrollment in our Phase II clinical trial for XIAFLEX for human lipoma ahead of schedule, and that we remain on track to complete enrollment in our canine lipoma Phase II trial in the first half of 2013. We plan to report top-line data for both trials in the second half of 2013. We are also encouraged by the clinical progress Auxilium is making for XIAFLEX in Dupuytren's contracture patients with multiple palpable cords, cellulite and frozen shoulder. We anticipate reporting development progress for all of these indications beginning later this year."
Fourth Quarter & Full Year 2012 Financial ResultsBioSpecifics reported net income of $1.1 million for the fourth quarter ended December 31, 2012, or $0.17 per basic share and $0.16 per share on a fully diluted basis, compared to net income of $71,326, or $0.01 per basic and diluted common share for the same period in 2011. For the full year ended December 31, 2012, the Company reported net income of $3.0 million, or $0.47 per share on a basic and $0.43 per share on a fully diluted basis, compared to net income of $6.6 million, or $1.04 per share on a basic and $0.95 on a fully diluted basis in the same period in 2011.
Total revenue for the fourth quarter of 2012 was $3.5 million, compared to $2.6 million for the same period in 2011. For the full year ended December 31, 2012, total revenue was $11.1 million, compared to $11.4 million in the same period in 2011.
Royalty, mark-up on cost of goods sold, and earn-out revenues for the fourth quarter of 2012 were $2.5 million, compared to $1.9 million for the same period in 2011. Royalty and mark-up on cost of goods sold revenues recognized under BioSpecifics' agreement with Auxilium Pharmaceuticals, Inc. (Auxilium) for the fourth quarter of 2012 were $1.6 million, compared to $1.1 million for the same period in 2011. Royalty revenues recognized from DFB Biotech, Inc. for the fourth quarter of 2012 were $0.8 million compared to $0.7 million for the same period in 2011. Total royalty, mark-up on cost of goods sold and earn-out revenues for the year ended December 31, 2012 increased to $9.2 million as compared to $6.3 million in the same period in 2011.
Total licensing fees consisting of licensing and sublicensing fees and milestones for the year ended December 31, 2012 were $2.0 million, compared to $5.0 million in the same period in 2011. Licensing fees recognized from Auxilium for the full year 2012 and 2011 were $0.4 million in each period. These licensing fees related to cash payments received in prior years and amortized over the expected development period. Sublicensing fees recognized for the full year ended December 31, 2012 were $570,000 compared to $750,000 in the same period in 2011. 2012 sublicensing fees were related to the $10.0 million paid to Auxilium by Actelion Pharmaceuticals Ltd. (Actelion) for the rights to develop and commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico. 2011 sublicensing fees were related to the $15.0 million paid to Auxilium by Asahi Kasei Pharma Corporation for the rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Japan.
Milestone revenue recognized for the years ended December 31, 2012 and 2011 were $1.0 million and $3.8 million, respectively. In 2012, BioSpecifics recognized a $1.0 million milestone related to the U.S. Food and Drug Administration's (FDA) December 2012 acceptance of Auxilium's supplemental Biologics License Application (sBLA) for XIAFLEX for the potential treatment of Peyronie's disease. BioSpecifics also recognized a milestone of $28,500 related to the Notice of Compliance (approval) granted by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture for adult patients with a palpable cord in Canada to Auxilium. In 2011, BioSpecifics recognized a $2.6 million milestone related to the first sale of XIAFLEX in Europe, a $637,500 milestone related to the first sale of XIAFLEX in Germany, and a $637,500 milestone related to the first sale of XIAFLEX in Spain.
Research and development expenses for the fourth quarters of 2012 and 2011 were $0.3 million in each period. For the year ended December 31, 2012, research and development expenses were $1.2 million, compared to $1.0 million in the same period in 2011. This increase in research and development expenses was primarily due to expenses related to BioSpecifics' internally-managed human and canine lipoma XIAFLEX clinical development programs.
General and administrative expenses for the fourth quarter of 2012 were $1.2 million, compared to $1.1 million for the same period in 2011. For the year ended December 31, 2012, general and administrative expenses were $4.8 million, compared to $5.2 million in the same period in 2011. The decrease in general and administrative expenses was due to lower stock based compensation and general legal fees partially offset by third party royalty fees and consulting fees.
Income tax expenses for the fourth quarter of 2012 were $1.0 million as compared to $1.2 million for the same period in 2011. For the year ended December 31, 2012, income tax expense was $2.2 million as compared to an income tax benefit of $1.3 million in the same period of 2011. In the 2011 period, the $1.3 million in income tax benefit consisted of an income tax expense of $2.3 million which was offset by a one-time $3.6 million tax benefit related to the Company's deferred tax asset valuation allowance and the recording of the Company's deferred tax assets as BioSpecifics believes that its tax assets are more likely than not to be realized as it achieved sustained profitability on an on-going annual basis. In making such determination, the Company considered all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent financial operations.
As of December 31, 2012, BioSpecifics had cash and cash equivalents and investments of $8.5 million, compared to $9.0 million on September 30, 2012.
Recent Corporate Highlights:
Upcoming Anticipated Events:
Upcoming Annual Meeting:
Webcast and Conference CallBioSpecifics will host a conference call today at 4:30 p.m. EDT to discuss these fourth quarter and full year 2012 results.
In order to participate in the conference call, please dial 1-800-860-2442 (domestic) or 1-412-858-4600 (international). The live webcast can be accessed under "Calendar of Events" in the Investor Relations section of the Company's website at www.biospecifics.com or you may use the link: http://www.videonewswire.com/event.asp?id=92436.
A replay of the call will be available one hour after the end of the conference on March 12, 2013 until 9:00 a.m. EDT on March 27, 2013. To access the replay, please dial 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and reference the access code 10025434. The archived webcast will be available for 90 days in the Investor Relations section of BioSpecifics' website at www.biospecifics.com.
About BioSpecifics Technologies Corp.BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications. Injectable collagenase is currently marketed as XIAFLEX® in the U.S. for the treatment of adult Dupuytren's contracture patients with a palpable cord by Auxilium Pharmaceuticals, Inc. (Auxilium) and is approved for Dupuytren's contracture in the European Union, Switzerland and Canada. XIAFLEX is also in clinical development for the treatment of several additional promising indications. A supplemental Biologics License Application is currently under standard review at the U.S. Food and Drug Administration for XIAFLEX for the treatment of Peyronie's disease. Auxilium is also testing XIAFLEX for frozen shoulder syndrome (adhesive capsulitis) and cellulite in Phase IIa and Phase Ib clinical trials, respectively. BioSpecifics is currently managing the development of XIAFLEX for two indications, human lipoma and canine lipoma (Chien-804), both of which are in Phase Il clinical trials. Auxilium is currently partnered with Asahi Kasei Pharma Corporation for the development and commercialization of injectable collagenase for Dupuytren's contracture and Peyronie's disease in Japan and with Actelion Pharmaceuticals Ltd. for the same indications in Canada, Australia, Brazil and Mexico. Pfizer Inc. has marketing rights to XIAPEX® (the EU trade name for XIAFLEX) for Dupuytren's contracture in 46 countries in Eurasia through April 24, 2013. For more information, please visit www.biospecifics.com.
Forward-Looking StatementsThis release includes "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are "forward-looking statements." The forward-looking statements include statements concerning, among other things, the timing of the review and potential approval by the FDA of XIAFLEX as a treatment for Peyronie's disease; the timing of the potential US commercial launch and submission of the MAA to the EMA with respect to the use of XIAFLEX for the treatment of Peyronie's disease and its commercial potential; the development progress of various indications and the extent to which these indications are promising; the expectation of XIAFLEX to be the first and only biologic therapy indicated for the treatment of Peyronie's disease; the timing of completing enrollment in BioSpecifics' Phase II trial of XIAFLEX for the treatment of canine lipoma; the timing of reporting top-line data from BioSpecifics' Phase II trials of XIAFLEX for the treatment of human and canine lipoma; the anticipated net revenues of XIAFLEX in respect of Dupuytren's contracture-related sales; the timing of making XIAFLEX available in Canada as a treatment for Dupuytren's contracture; the timing of results from Auxilium's clinical trials for Dupuytren's contracture (release of top-line data for contracture retreatment clinical trial and multi-cord trial) and frozen shoulder; the potential for Auxilium to seek from the FDA a XIAFLEX label expansion for the concurrent treatment of multiple palpable cords in adult Dupuytren's contracture patients; the timing for Auxilium to initiate a phase II trial of XIAFLEX as a treatment for cellulite; the timing for Auxilium to initiate a Phase II trial of XIAFLEX as a treatment for frozen shoulder; and the potential market for XIAFLEX as a treatment for various indications. In some cases, these statements can be identified by forward-looking words such as "believe," "expect," "anticipate," "plan," "estimate," "likely," "may," "will," "could," "continue," "project," "predict," "goal," the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on BioSpecifics' current expectations and its projections about future events. There are a number of important factors that could cause BioSpecifics' actual results to differ materially from those indicated by such forward-looking statements, including the timing of regulatory filings and action; the ability of BioSpecifics' partner, Auxilium, and its partners, Asahi Kasei Pharma Corporation and Actelion Pharmaceuticals Ltd., to achieve their objectives for XIAFLEX in their applicable territories; the market for XIAFLEX in, and initiation and outcome of clinical trials for, additional indications including frozen shoulder, cellulite, human lipoma and canine lipoma, all of which will determine the amount of milestone, royalty and sublicense income BioSpecifics may receive; the potential of XIAFLEX to be used in additional indications; the timing of results of any clinical trials; the receipt of any applicable milestone payments from Auxilium; whether royalty payments BioSpecifics is entitled to receive will exceed set-offs; and other risk factors identified in BioSpecifics' Annual Report on Form 10-K for the year ended December 31, 2011, its Quarterly Reports on Form 10-Q for the first, second and third quarters of 2012 and its Current Reports on Form 8-K filed with the Securities and Exchange Commission. All forward-looking statements included in this release are made as of the date hereof, and BioSpecifics assumes no obligation to update these forward-looking statements.
BioSpecifics Technologies Corp.Consolidated Statements of OperationsThree months endedTwelve months endedDecember 31December 312012201120122011Revenues:(Unaudited)(Audited)Net sales$
21,998Royalties2,457,2991,853,2769,155,6546,314,959Licensing revenue1,044,881746,7751,971,2055,012,102Consulting fees---46,667Total Revenues3,508,2712,608,59211,145,07811,395,726Costs and expenses:Research and development302,636265,0631,249,755972,078General and administrative1,160,7031,059,1944,774,8285,231,881Total costs and expenses1,463,3391,324,2576,024,5836,203,959Operating income2,044,9321,284,3355,120,4955,191,767Other income (expense):Interest Income7,07814,71934,63455,780Other, net-1,344-15,8237,07816,06334,63471,603Income before income tax2,052,0101,300,3985,155,1295,263,370Income tax benefit (expense)(951,054)(1,229,072)(2,174,054)1,338,256Net income$ 1,100,956$
2,981,075$ 6,601,626Basic net income per share$
.04Diluted net income per share$
.95Shares used in computation of basicnet income per share6,381,6656,350,7706,351,2456,340,648Shares used in computation of dilutednet income per share6,971,4536,857,9666,981,5276,952,386BioSpecifics Technologies Corp.Selected Consolidated Balance Sheet Data (Unaudited)December 3120122011Cash and cash equivalents$ 3,383,737$
3,196,831Short term investments5,120,0005,000,000Accounts and income tax receivable, net5,133,4303,481,637Deferred tax assets1,573,0513,047,955Working capital13,151,27311,970,264Total assets18,390,26416,265,073Long-term liabilities207,390276,520Total stockholders' equity17,458,34614,872,314
|SOURCE BioSpecifics Technologies Corp.|
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