LYNBROOK, N.Y., March 11, 2011 /PRNewswire/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC; the "Company"), a biopharmaceutical company developing first in class collagenase-based products, today announced its financial results for the fourth quarter and full year ended December 31, 2010.
"2010 was an exciting year for the Company, but we are even more excited about 2011 as we look forward to sales growth of XIAFLEX® in the U.S., as well as Pfizer's launch of XIAPEX® in Europe later this year," said Thomas Wegman, the Company's President. "We are very pleased that the European Commission has granted marketing authorization of XIAPEX for the treatment of Dupuytren's contracture in adult patients with a palpable cord, and we look forward to Pfizer's launch of XIAPEX in Europe later this year."
Financial Results: The Company reported net income of $0.1 million for the quarter ended December 31, 2010, or $0.02 per share on a basic and fully diluted basis, compared to a net loss of $0.5 million or $0.09 per share on a basic and fully diluted basis, for the same period in 2009. For the full year ended December 31, 2010, the Company reported a net loss of $1.5 million, or $0.24 per share on a basic and fully diluted basis, compared to a net loss of $2.0 million, or $0.32 per share on a basic and fully diluted basis in 2009.
Revenue for the fourth quarter of 2010 was $1.1 million, compared to $0.8 million for the same period in 2009. For the full year ended December 31, 2010, revenue was $5.7 million, compared to $3.2 million for the full year 2009. Total royalty and earn-out revenues for the year ended December 31, 2010 increased by $1.0 million due to the launch of XIAFLEX in March 2010 and higher net sales of Santyl under the agreement with DFB Biotech, Inc. and its affiliates. Milestone revenue recognized for the year ended December 31, 2010 was $2.3 million, which includes $1.3 million of the $15 million paid to the Company's partner Auxilium Pharmaceuticals, Inc by Pfizer Inc. for the completion of the Marketing Authorization Application for XIAFLEX for Dupuytren's contracture in Europe. The Company also received a milestone of $1.0 million related to the FDA's approval of XIAFLEX for Dupuytren's contracture in February 2010 and in connection with the notification in June 2010 to Auxilium of the Company's election not to commercially manufacture XIAFLEX.
Research and development expenses for the fourth quarter of 2010 were a credit of $34,256 compared to $0.1 million for the same period in 2009. This credit in research and development was mainly due to an adjustment during the quarter to the amount of third party lyophilization expenses reported to us by Auxilium. For the year ended December 31, 2010, research and development expenses were $1.2 million, compared to $0.5 million in 2009. This increase in research and development expenses was primarily due to third party development costs that are reimbursable to BioSpecifics.
General and administrative expenses for the fourth quarter of 2010 were $1.5 million, compared to $1.3 million for the same period in 2009. For the year ended December 31, 2010, general and administrative expenses were $6.5 million, compared to $4.8 million in 2009. The increase in general and administrative expenses was due to legal fees, stock based compensation and services related to investor relations partially offset by lower patent costs.
As of December 31, 2010, the Company had cash, cash equivalents and investments of $7.8 million, compared to $8.5 million on December 31, 2009.
Fourth Quarter 2010 and Recent Corporate Highlights:
Webcast and Conference CallThe Company will host a conference call today at 8:30 am ET to discuss its fourth quarter and full year 2010 results and provide a corporate update.
To participate in the conference call, please dial 800-860-2442 (domestic) or 412-858-4600 (international). The presentation will be available via a live webcast at: www.videonewswire.com/event.asp?id=76839.
A replay of the call will be available one hour after the conference ends on March 11, 2011 until 9:00 am ET on March 18, 2011. To access the replay, please dial 877-344-7529 (domestic) or 412-317-0088 (international) and reference the access code 448479. The archived webcast will be available for 90 days in the Investor Relations section of the Company's 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, three of which include: Dupuytren's contracture, Peyronie's disease, and frozen shoulder (adhesive capsulitis). Its strategic partner Auxilium Pharmaceuticals, Inc. markets XIAFLEX® in the U.S. for the treatment of Dupuytren's contracture. Pfizer, Inc. is responsible for marketing XIAPEX® in Europe. More information about The Company may be found on its website at www.biospecifics.com.
Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, its expected revenue growth, and any other statements containing the words "believes," "expects," "anticipates," "plans," "estimates" and similar expressions, are forward-looking statements. There are a number of important factors that could cause its actual results to differ materially from those indicated by such forward-looking statements, including the statements made by the Company and by its partner Auxilium regarding the availability of a XIAFLEX specific CPT code; the ability of Pfizer to achieve its objectives for XIAPEX in Europe; the success of the Phase III trials for XIAFLEX for the treatment of Peyronie's disease, which will determine the amount of milestone, royalty and sublicense income payments the Company may receive; the outcome of the dispute with Auxilium; the Company's ability to restart the Chien-803 trial; the Company's ability to initiate and complete clinical trials in additional indications; and other risk factors identified in the Company's Form 10-K for the year ended December 31, 2009 and its reports on Form 8-K filed with the U.S. Securities and Exchange Commission. All forward-looking statements included in this press release are made as of the date hereof, and the Company assumes no obligation to update these forward-looking statements. BioSpecifics Technologies Corp.Consolidated Statements of OperationsThree months endedTwelve months endedDecember 31December 312010200920102009Revenues:(Unaudited)(Audited) Net sales
961,956415,0002,320,7291,271,597 Licensing revenue
109,276266,2813,026,1111,565,125 Consulting fees
70,00070,000280,000280,000Total Revenues1,143,412754,1225,661,3483,155,757Costs and expenses: Research and development
(34,256)135,6631,223,931488,646 General and administrative
1,500,7961,347,6786,470,4494,832,019Total costs and expenses1,466,5401,483,3417,694,3805,320,665Operating income (loss)(323,128)(729,219)(2,033,032)(2,164,908)Other income (expense): Interest Income
17,04827,00886,31055,693 Interest expense
---(39) Other, net
13,130-13,130(8,863) Qualifying Therapeutic Discovery Grant
426,403-426,403-456,58127,008525,84346,791Income (loss) before income tax
133,453(702,211)(1,507,189)(2,118,117) Income tax benefit (expense)
6,716161,574(1,351)161,574Net income (loss)$ 140,169$ (540,637)$ (1,508,540)$ (1,956,543)Basic net income (loss) per share$
(0.32)Diluted net income (loss) per share$
(0.32)Shares used in computation of basicnet income (loss) per share6,280,2686,159,8236,261,2146,065,939Shares used in computation of dilutednet income (loss) per share7,182,5586,159,8236,261,2146,065,939BioSpecifics Technologies Corp.Selected Consolidated Balance Sheet Data(Unaudited)December 3120102009Cash and cash equivalents$ 2,470,852$ 3,950,389Short term investments5,360,9704,548,541Accounts and income tax receivable, net2,171,5111,712,220Working capital5,990,8995,768,760Total assets11,518,70111,748,478Long-term liabilities713,6191,150,721Total stockholders' equity6,700,7236,092,107
|SOURCE BioSpecifics Technologies Corp.|
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