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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event Reported): August 6, 2010
BIOSPECIFICS TECHNOLOGIES CORP.
Delaware | 001-34236 | 11-3054851 |
(State or Other Jurisdiction | (Commission File Number) | (I.R.S. Employer |
Of Incorporation) | Identification No.) |
35 Wilbur Street
Lynbrook, NY 11563
(Address of Principal Executive Office) (Zip Code)
516.593.7000
(Registrants telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
INTRODUCTORY COMMENT
Throughout this Current Report on Form 8-K, the terms "we," "us," "our" and "Company" refer to BioSpecifics Technologies Corp.ITEM 2.02. | RESULTS OF OPERATIONS AND FINANCIAL CONDITION |
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
ITEM 9.01. | FINANCIAL STATEMENTS AND EXHIBITS |
(d) | Exhibits |
99.1 | Press release dated August 6, 2010 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Date: August 6, 2010 | BIOSPECIFICS TECHNOLOGIES CORP. |
| |
(Registrant) | |
/s/ Thomas L. Wegman | |
| |
Thomas L. Wegman | |
President |
EXHIBIT INDEX
Exhibit No. | Description | |
99.1 | Press release dated August 6, 2010 |
Exhibit 99.1
BioSpecifics Technologies Corp. Reports
Second Quarter 2010 Financial Results
LYNBROOK, NY August 6, 2010 BioSpecifics Technologies Corp. (NASDAQ: BSTC; the Company), a biopharmaceutical company developing first in class collagenase-based products, today announced its financial results for the second quarter ended June 30, 2010. The Companys partner, Auxilium Pharmaceuticals, Inc. (Auxilium) markets XIAFLEX® (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord.
We are very pleased with the efficacy and safety of XIAFLEX seen in clinical practice based on reports from the early stages of the launch by our partner Auxilium, commented Thomas L. Wegman, President of BioSpecifics. In the future, we see significant growth potential for the product. Auxilium has announced a positive outcome of its end of Phase 2 meeting with the FDA for XIAFLEX for Peyronies disease, and we look forward to the initiation of the Phase 3 pivotal trials by the end of the year. In addition, Pfizer continues its efforts to achieve registration of XIAFLEX for Dupuytrens contracture in Europe.
Financial Results
The Company reported a net loss of $0.9 million for the second quarter ended June 30, 2010, or $0.15 per basic and diluted common share, compared to a net loss of $0.1 million, or $0.01 per basic and diluted common share, for the same period in 2009. As of June 17, 2010, the Company revised its compensation policy and determined that, absent special circumstances, no new options will be granted to directors, officers, employees or consultants.
Total revenues for the second quarter ended June 30, 2010 were $0.9 million as compared to $1.2 million for the same period in 2009. The decrease in revenues was mainly attributable to the recognition of less milestone and licensing revenue during the second quarter ended June 30, 2010. For the second quarter ended June 30, 2010 the Company recognized the remaining portion, $0.15 million, of a $1.0 million milestone related to the approval by the U.S. Food and Drug Administration (FDA) of XIAFLEX for Dupuytrens contracture in February 2010. This remaining portion was recognized in connection with the Companys notification to Auxilium of its election not to commercially manufacture XIAFLEX. In addition, licensing revenues recognized are related to the cash payments received in prior years and amortized over the expected development period under the Companys agreement with Auxilium. The decrease in licensing revenues recognized during the second quarter of 2010 was primarily due to the completed recognition in the first quarter of 2010 of licensing revenues associated with the Dupuytrens contracture indication. The revenue for the second quarter ended June 30, 2010 does not include royalties or markup on cost of goods sold for XIAFLEX sales.
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Research and development expenses for the second quarter ended June 30, 2010 were $0.1 million, compared to $0.1 million for the same period in 2009. Research and development expenses include employee related expenses, preclinical expenses, costs of materials, lab expense, facility costs and overhead.
General and administrative expenses for the second quarter ended June 30, 2010 totaled $1.6 million, compared to $1.1 million for the same period in 2009. The increase in general and administrative expenses was primarily due to outside legal fees, stock-based compensation, and consulting and outside services related to investor relations partially offset by lower patent expenses.
As of June 30, 2010, BioSpecifics held cash, cash equivalents and short-term investments of $9.9 million, compared to $11.3 million on March 31, 2010.
XIAFLEX for Dupuytrens Contracture Update
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On August 5, 2010, Auxilium provided net revenue guidance for third quarter sales of XIAFLEX. Auxilium stated that net revenues from sales of XIAFLEX are expected to be in the range of $4.4 million to $5.4 million. | |
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As of July 31, 2010, Auxilium reported the following leading indicators of the XIAFLEX launch: | |
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1,747 physicians and 1,216 sites have completed the training and enrollment process; | |
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2,042 insurance verification requests and 1,052 referrals to specialty pharmacies have been received by the Auxilium call center; | |
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348 sites in the U.S. have prescribed XIAFLEX and approximately 241 sites (69%) have treated two or fewer patients, 89 sites (26%) have treated 3-10 patients and 16 sites (5%) have treated more than 10 patients; |
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8 of the 10 Medicare Administrative Contractors (MAC) that manage claims processing across the 15 MAC jurisdictions in the U.S. have issued final guidelines on covering XIAFLEX; |
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Auxilium believes that approximately 91% of insured lives have access to XIAFLEX. |
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On June 8, 2010, Auxilium announced results from its ongoing long-term extension study, which demonstrated a two year nominal recurrence rate of 19.3% for joints previously treated successfully with XIAFLEX. For Metacarpal Phalangeal joints the two year nominal rate was 13.6%, while Proximal Intra-Phalangeal joints showed a 34.1% nominal recurrence. Auxilium believes that these rates compare favorably to recurrence rates from current surgical treatments, including open fasciectomy and needle aponeurotomy. |
Corporate and Pipeline Update
On July 12, 2010, Auxilium announced that it held its end of Phase 2 meeting with the FDA in late June 2010 regarding development of XIAFLEX for the treatment of Peyronie's disease and that, as a result, Auxilium was reaffirming its plan to commence pivotal Phase 3 trials by the end of 2010.
On June 4, 2010, the Company announced that its Board of Directors authorized the repurchase of up to $2 million of its outstanding common stock. This decision reflected the Company's continued commitment to increasing value for its stockholders and its confidence that it will achieve its goals.
Upcoming Milestones
Following are the Company's upcoming milestones:
There will be a presentation at the American Society for Surgery of the Hand (ASSH) 2010 Annual Meeting on October 8, 2010 entitled New Advances in the Treatment of Dupuytrens.
Auxilium plans to commence Phase 3 pivotal trials in Peyronies disease by the end of 2010.
Pfizer continues its efforts to achieve registration of XIAFLEX for Dupuytrens contracture in Europe and is preparing for launch.
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BioSpecifics expects to initiate a trial for injectable collagenase in lipoma by the end of 2010.
Auxilium plans to prioritize new pipeline indication(s) for XIAFLEX by year end 2010.
Webcast and Conference Call
The Company will host a conference call today at 8:30 am EDT to discuss its second quarter 2010 results and to 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: http://www.videonewswire.com/event.asp?id=70830.
A replay of the call will be available one hour after the conference ends on August 6, 2010 until 9:00 am EDT on August 13, 2010. To access the replay, please dial 877-344-7529 (domestic) or 412-317-0088 (international) and reference the access code 442720. The archived webcast will be available for 90 days in the Investor Relations section of the BioSpecifics 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 contracture, Peyronie's disease, and frozen shoulder (adhesive capsulitis). Its strategic partner Auxilium has announced the approval of XIAFLEX by the FDA in the U.S. for the treatment of Dupuytren's contracture. Pfizer, Inc. is responsible for marketing XIAFLEX in Europe. More information about BioSpecifics may be found on its website at http://www.biospecifics.com.
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Forward-Looking Statements
This 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 BioSpecifics 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 BioSpecifics and by its partner Auxilium regarding progress toward achievement of Auxiliums objectives for the U.S. launch of XIAFLEX for Dupuytrens contracture in 2010; the ability of Pfizer to achieve its objectives for XIAFLEX in Europe; the percentage of insured lives in the U.S. with access to XIAFLEX; the effect of the identified leading indicators on the success of the XIAFLEX launch and future net revenues; the timing of initiation of Phase III trials for XIAFLEX for the treatment of Peyronies disease, which will determine the amount of milestone, royalty and sublicense income payments BioSpecifics may receive; the Companys 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 filed with the SEC. There may be additional risks that BioSpecifics does not currently know or that BioSpecifics currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect; therefore, any such factors or forward-looking statements should not be relied upon. BioSpecifics disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Contact:
BioSpecifics Technologies Corp.
Thomas L. Wegman, President
(516) 593-7000
thomas_wegman@biospecifics.com
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BioSpecifics Technologies
Corp.
Consolidated Statements of Operations
(Unaudited)
Three months ended | Six months ended | |||||||||||
June 30, | June 30, | |||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||
Revenues: | ||||||||||||
Net sales | $ | 18,209 | $ | 9,914 | $ | 27,145 | $ | 17,105 | ||||
Royalties | 507,322 | 375,400 | 539,134 | 375,400 | ||||||||
Licensing fees | 259,276 | 766,281 | 2,807,560 | 1,032,562 | ||||||||
Consulting fees | 70,000 | 70,000 | 140,000 | 140,000 | ||||||||
Total Revenues | 854,807 | 1,221,595 | 3,513,839 | 1,565,067 | ||||||||
Costs and expenses: | ||||||||||||
Research and development | 144,799 | 124,192 | 1,041,616 | 240,063 | ||||||||
General and administrative | 1,646,165 | 1,140,485 | 3,680,343 | 2,307,456 | ||||||||
Total costs and expenses | 1,790,964 | 1,264,677 | 4,721,959 | 2,547,519 | ||||||||
Operating loss | (936,157 | ) | (43,082 | ) | (1,208,120 | ) | (982,452 | ) | ||||
Other income (expense): | ||||||||||||
Investment Income | 25,925 | 1,688 | 51,775 | 4,545 | ||||||||
Interest income (expense) | - | (39 | ) | - | (39 | ) | ||||||
Other income (expense) | - | - | - | (9,463 | ) | |||||||
25,925 | 1,649 | 51,775 | (4,957 | ) | ||||||||
Loss before income tax | (910,232 | ) | (41,433 | ) | (1,156,345 | ) | (987,409 | ) | ||||
Income tax expense | - | (46,376 | ) | (8,067 | ) | (46,376 | ) | |||||
Net loss | $ | (910,232 | ) | $ | (87,809 | ) | $ | (1,164,412 | ) | $ | (1,033,785 | ) |
Basic and diluted net loss per share | $ | (0.15 | ) | $ | (0.01 | ) | $ | (0.19 | ) | $ | (0.17 | ) |
Shares used in computation of basic and diluted net loss per share | 6,273,945 | 6,014,312 | 6,244,136 | 6,011,588 |
BioSpecifics Technologies
Corp.
Selected Consolidated Balance Sheet Data
(Unaudited)
June 30, | December 31, | |||||
2010 | 2009 | |||||
Cash and cash equivalents | $ | 5,304,216 | $ | 3,950,389 | ||
Short term investments | 4,548,541 | 4,548,541 | ||||
Accounts and income tax receivable, net | 1,027,787 | 1,712,220 | ||||
Working capital | 5,983,286 | 5,768,760 | ||||
Total assets | 12,483,363 | 11,748,478 | ||||
Long-term liabilities | 932,170 | 1,150,721 | ||||
Total stockholders' equity | 6,484,085 | 6,092,107 |
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