Thursday November 26 2009 | Biotechnology feed | All feeds
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BioSpecifics Technologies Corp.http://www.biospecifics.com Biospecifics Technologies Corporation, Lynbrook NY, United States of America. A pharmaceutical company with a major focus on wound healing and tissue remodeling. Reissue with Tables: BioSpecifics Technologies Corp. Reports Third Quarter 2009 Financial ResultsFriday 6th of November 2009 13:00
-- In its September 3, 2009 edition, The New England Journal of Medicine
published data from the pivotal CORD I Phase III clinical trial of
XIAFLEX for the treatment of Dupuytren's disease, a debilitating
disorder resulting from excessive collagen deposition that causes
contractures of the fingers, in an article entitled "Injectable
Collagenase Clostridium Histolyticum for Dupuytren's Contracture." The
article describes the positive results observed in the largest,
prospective, double blind, placebo controlled clinical trial ever
conducted in the field of Dupuytren's contracture.
-- On September 16, 2009, the Arthritis Advisory Committee of the U.S. Food
and Drug Administration (FDA) unanimously recommended, by a vote of 12
to 0, that the FDA approve XIAFLEX for the treatment of Dupuytren's
disease.
Webcast and Conference Call A replay of the call is available until 9:00am ET on November 12, 2009. To access the replay, please dial 877-344-7529 (domestic) or 412-317-0088 (international) and reference the access code 435394. The archived webcast will be available for 90 days in the Investor Relations section of the Company's website at http://www.biospecifics.com. About BioSpecifics Technologies Corp. BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for eleven clinical indications, three of which include: Dupuytren's disease, Peyronie's disease, and frozen shoulder (adhesive capsulitis). Its strategic partner Auxilium has announced the acceptance of the Biologic License Application and Priority Review by the FDA's Arthritis Advisory Committee for injectable collagenase XIAFLEX in the treatment of Dupuytren's disease, and on September 16, 2009, the Arthritis Advisory Committee unanimously recommended, by a vote of 12 to 0, that the FDA approve XIAFLEX for the treatment of Dupuytren's disease. Pfizer, Inc. is responsible for marketing XIAFLEX product in Europe. Forward Looking Statements This press release includes 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 the Company's actual results to differ materially from those indicated by such forward-looking statements, including the ability of its partner Auxilium to obtain regulatory approval of XIAFLEX in the United States for Dupuytren's disease and Peyronie's disease, the preparedness of Auxilium for the commercial launch of XIAFLEX for the treatment of Dupuytren's disease and the ability of Pfizer, Inc. to obtain regulatory approval of XIAFLEX in its territory for the same indications, which will determine the amount of milestone, royalty and sublicense income payments the Company may receive; the amount of earn-out payments the Company may receive from DFB Biotech and its affiliates; whether Auxilium exercises its option under the license agreement between Auxilium and the Company for additional indications; the potential benefits of the Company's existing license and development agreements; the Company's estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the Company's Form 10-K for the year ended December 31, 2008, the Form 10-Q for the quarter ended June 30, 2009 and any subsequent reports filed with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
BioSpecifics Technologies Corporation
Consolidated Statements of Operations
(Unaudited)
Three months ended Nine months ended
September 30, September 30,
2009 2008 2009 2008
---- ---- ---- ----
Revenues:
Net sales $19,089 $13,042 $36,194 $29,841
Royalties 481,197 - 856,597 2,028
Licensing fees 266,282 266,281 1,298,844 798,844
Consulting fees 70,000 70,000 210,000 354,185
--------- --------- --------- ---------
Total
Revenues 836,568 349,323 2,401,635 1,184,898
Costs and expenses:
Research and
development 112,920 71,737 352,983 260,440
General and
administrative 1,176,885 866,574 3,484,341 2,840,346
--------- --------- --------- ---------
Total costs and
expenses 1,289,805 938,311 3,837,324 3,100,786
--------- --------- --------- ---------
Operating loss (453,237) (588,988) (1,435,689) (1,915,888)
Other income (expense):
Interest Income 24,140 31,511 28,685 89,314
Interest expense - 46,979 (39) 46,528
Other, net 600 104,203 (8,863) 108,730
--------- --------- --------- ---------
24,740 182,693 19,783 244,572
------- ------- ------- -------
Loss before benefit
for income tax (428,497) (406,295) (1,415,906) (1,671,316)
Income tax benefit 46,376 192,287 - 192,287
--------- --------- --------- ---------
Net (loss) $(382,121) $(214,008) $(1,415,906) $(1,479,029)
========= ========= =========== ===========
Basic and diluted
net loss per share $(0.06) $(0.04) $(0.23) $(0.25)
====== ====== ====== ======
Shares used in computation
of basic and diluted
net loss per share 6,075,758 5,976,937 6,034,301 5,803,497
========= ========= ========= =========
BioSpecifics Technologies Corporation
Selected Consolidated Balance Sheet Data
(Unaudited)
September 30, December 31,
2009 2008
---- ----
Cash and cash equivalents $4,267,591 $3,494,150
Short term investments 5,022,854 900,000
Accounts and income
tax receivable, net 1,482,616 6,952,781
Working capital 9,157,129 9,422,245
Total assets 12,337,717 12,831,361
Long-term liabilities 4,321,154 4,660,427
Total stockholders' equity 6,394,870 6,178,539
SOURCE BioSpecifics Technologies Corp. Browse other news from this organisation: BioSpecifics Technologies Corp. Source PR Newswire  |
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