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 9, 2012
BIOSPECIFICS TECHNOLOGIES
CORP.
(Exact name of registrant as specified in its
charter)
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
On August 9, 2012, the Company announced its financial and operating results for the fiscal quarter ended June 30, 2012. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.
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 9, 2012 |
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 hereunto duly authorized.
Date: August 9, 2012 | BIOSPECIFICS TECHNOLOGIES CORP. |
| |
(Registrant) | |
/s/ Thomas L. Wegman | |
| |
Thomas L. Wegman | |
President |
EXHIBIT INDEX
Exhibit No. | Description |
99.1 | Press release dated August 9, 2012 |
BioSpecifics Technologies Corp. Reports Second
Quarter
2012 Financial Results
LYNBROOK, NY August 9, 2012 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in Europe and Eurasia, today announced its financial results for the second quarter ended June 30, 2012 and provided a corporate update.
We are very pleased with the clinical and regulatory progress of XIAFLEX in recent months and are excited about the upcoming anticipated milestones for the remainder of this year, reflected Thomas L. Wegman, President of BioSpecifics. We announced positive top-line results from Auxiliums two IMPRESS Phase III clinical trials of XIAFLEX for Peyronies disease in June and expect Auxilium to submit a sBLA filing by the end of the year. BioSpecifics also initiated two Phase II clinical trials in canine and human lipomas and we anticipate we will complete enrollment for both of these studies in the first half of 2013. Additionally, XIAFLEX was recently approved in Canada for Dupuytrens contracture and Auxiliums partner Actelion expects to file for approval in Australia, Brazil and Mexico by the end of 2012.
Second Quarter 2012 Financial Results
BioSpecifics reported a net income of $0.7 million for the second quarter ended June 30, 2012, or $0.11 per basic and $0.10 per diluted share, compared to a net income of $2.6 million, or $0.40 per basic and $0.36 per diluted share, for the same period in 2011.
Total revenue for the second quarter of 2012 was $2.6 million, compared to $5.0 million for the same period in 2011.
Royalty, mark-up on cost of goods sold, and earn-out revenues for the second quarter ended June 30, 2012 were $2.5 million, compared to $1.7 million for the same period in 2011. Royalty and mark-up on cost of goods sold revenues recognized under the Companys agreement with Auxilium Pharmaceuticals, Inc. (Auxilium) for the second quarter of 2012 were $1.5 million, compared to $1.1 million for the same period in 2011. Royalty revenues recognized from DFB Biotech, Inc. for the second quarter of 2012 were $0.9 million, compared to $0.6 million for the same period in 2011.
Total licensing revenue consisting of licensing, sublicensing fees and milestones for the second quarter ended June 30, 2012 was $0.1 million, compared to $3.3 million for the same period in 2011. Licensing fees recognized from Auxilium for the second quarters of 2012 and 2011 were $0.1 million in each period. These licensing fees related to cash payments received in prior years and amortized over the expected development period. Milestones recognized in the second quarter of 2012 were zero, compared to $3.2 million in the same period in 2011. In the second quarter of 2011, milestones recognized related to the $30 million regulatory milestone paid to Auxilium by its licensee Pfizer Inc. (Pfizer) following the first sale of XIAPEX in a major European Union market for Dupuytrens contracture and the $7.5 million paid to Auxilium by Pfizer for the launch of XIAPEX in Germany in the second quarter of 2011.
1
Research and development expenses for the second quarter ended June 30, 2012 were $0.4 million, compared to $0.3 million for the same period in 2011. The increase in research and development expenses was primarily due to expenses related to BioSpecifics clinical development programs.
General and administrative expenses for the second quarter ended June 30, 2012 were $1.1 million, compared to $1.4 million for the same period in 2011. The decrease in general and administrative expenses was due to lower general legal fees, stock based compensation and consulting services partially offset by third party royalty fees.
As of June 30, 2012, BioSpecifics had cash and cash equivalents and investments of $8.8 million, compared to $10.8 million on March 31, 2012.
Recent XIAFLEX Highlights for Dupuytrens Contracture:
Recent XIAFLEX Development Highlights for Peyronies Disease:
Recent XIAFLEX Proprietary Pipeline Development Highlights:
Upcoming Anticipated Milestones:
BioSpecifics Proprietary Indications for XIAFLEX: | |||
- |
BioSpecifics anticipates that it will complete enrollment for its 14 patient dose escalation Phase II trial for the treatment of human lipoma in the first half of 2013. | ||
- |
BioSpecifics anticipates that it will complete enrollment for Chien-804, its Phase II clinical trial evaluating 32 canines with benign subcutaneous lipomas randomized 1:1 XIAFLEX to placebo, in the first half of 2013. | ||
XIAFLEX for Dupuytrens Contracture: | |||
- |
Auxilium expects to initiate an open-label clinical trial evaluating XIAFLEX for the concurrent treatment of multiple palpable cords in approximately 600 adult patients with Dupuytrens contracture in the third quarter of 2012. Top-line data from this study are expected in the first half of 2014 and, if successful, this study may allow Auxilium to seek approval and label expansion for Dupuytren's contracture from the U.S. Food and Drug Administration (FDA). According to Auxilium, SDI Health, LLC estimates that 35 to 40% of annual Dupuytrens surgeries in the U.S. are performed to treat two or more cords concurrently. | ||
- |
Actelion expects to make XIAFLEX available to patients in Canada in the first half of 2013. In addition, Actelion expects to file for approval of XIAFLEX for the treatment of Dupuytren's contracture in Australia, Brazil and Mexico by the end of the 2012. | ||
Additional Clinical Indications for XIAFLEX: | |||
- |
Auxilium expects to submit a supplemental Biologics License Application (sBLA) filing to the FDA for XIAFLEX as a treatment for Peyronies disease by the end of 2012. If approved by the FDA, Auxilium expects to launch XIAFLEX as a treatment for Peyronies disease in the U.S. in late 2013. | ||
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Top-line results from the Phase Ib single site, open-label dose escalation study of XIAFLEX for the treatment of cellulite are expected in the fourth quarter of 2012. | ||
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Top-line results from the Phase IIa study of XIAFLEX for the treatment of frozen shoulder are expected in the first quarter of 2013. |
Webcast and Conference Call
The Company will host a conference call today at 8:30 a.m. EDT to discuss these second quarter 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 Companys website at www.biospecifics.com or you may use the link: http://www.videonewswire.com/event.asp?id=88477.
A replay of the call will be available one hour after the end of the conference on August 9, 2012 until 9:00 a.m. EDT on August 20, 2012. To access the replay, please dial 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and reference the access code 10016679. 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 (XIAFLEX®) for twelve clinical indications. Currently, XIAFLEX is marketed in the U.S. for the treatment of adult Dupuytren's contracture patients with a palpable cord by Auxilium Pharmaceuticals, Inc. (Auxilium) and is also in clinical development for the treatment of five additional promising indications. Auxilium has reported positive top-line results from two recently completed Phase III clinical trials for Peyronie's disease and is also evaluating XIAFLEX for frozen shoulder syndrome (adhesive capsulitis) and cellulite in Phase IIa and Phase Ib clinical trials, respectively. BioSpecifics is developing XIAFLEX internally for the treatment of human lipoma and canine lipoma, which are both in Phase II clinical trials. Auxilium has entered into three strategic partnerships for the ex-U.S. development and commercialization of injectable collagenase for Dupuytrens contracture and Peyronies disease. Pfizer Inc. has rights in Europe and Eurasia and injectable collagenase is currently marketed as XIAPEX® for Dupuytrens contracture in select European countries. Asahi Kasei Pharma Corporation has rights in Japan and Actelion Pharmaceuticals Canada Inc. has rights in Canada, Australia, Brazil and Mexico. For more information, please visit www.biospecifics.com.
Forward-Looking Statements
This 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 submission of a sBLA filing to the FDA for XIAFLEX as a treatment for Peyronies disease and subsequent launch in that indication; the potential market for XIAFLEX in human lipoma and canine lipoma; the timing for completing clinical trials for the use of XIAFLEX in the treatment of human lipoma, canine lipoma, cellulite and frozen shoulder; the potential for Auxilium to receive approval to expand the label for Dupuytrens contracture; and the timing of making XIAFLEX available to patients in Canada. 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 ability of BioSpecifics partner, Auxilium, and its partners, Pfizer Inc., Asahi Kasei Pharma Corporation and Actelion Pharmaceuticals Canada Inc., to achieve their objectives for XIAFLEX in their applicable territories; the potential market for XIAFLEX in a given indication, the potential of XIAFLEX to be used in additional indications, and the initiation, timing and outcome of clinical trials of XIAFLEX for additional indications; the timing of regulatory filings and action; the receipt of any applicable milestone payments from Auxilium; 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 and second 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.
Contact:
BioSpecifics Technologies Corp.
Thomas L. Wegman, President
(516) 593-7000
thomas_wegman@biospecifics.com
-Tables to Follow-
BioSpecifics Technologies Corp.
Consolidated Statements of
Operations
(Unaudited)
Three months ended | Six months ended | |||||||||||
June 30, | June 30, | |||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||
Revenues: | ||||||||||||
Net sales | $ | 1,246 | $ | 5,882 | $ | 8,750 | $ | 11,774 | ||||
Royalties | 2,491,313 | 1,706,166 | 4,391,282 | 2,651,247 | ||||||||
Licensing revenues | 109,275 | 3,296,776 | 788,550 | 4,156,051 | ||||||||
Consulting fees | - | - | - | 46,667 | ||||||||
Total Revenues | 2,601,834 | 5,008,824 | 5,188,582 | 6,865,739 | ||||||||
Costs and expenses: | ||||||||||||
Research and development | 404,346 | 270,799 | 653,898 | 482,865 | ||||||||
General and administrative | 1,149,926 | 1,418,016 | 2,238,648 | 2,927,542 | ||||||||
Total costs and expenses | 1,554,272 | 1,688,815 | 2,892,546 | 3,410,407 | ||||||||
Operating income | 1,047,562 | 3,320,009 | 2,296,036 | 3,455,332 | ||||||||
Other income: | ||||||||||||
Interest and other income | 9,771 | 31,167 | 19,264 | 47,727 | ||||||||
Income before income tax | 1,057,333 | 3,351,176 | 2,315,300 | 3,503,059 | ||||||||
Income tax benefit (expense) | (390,651 | ) | (781,835 | ) | (906,228 | ) | 2,757,405 | |||||
Net income | $ | 666,682 | $ | 2,569,341 | $ | 1,409,072 | $ | 6,260,464 | ||||
Basic net income per share | $ | 0.11 | $ | 0.40 | $ | 0.22 | $ | 0.99 | ||||
Diluted net income per share | $ | 0.10 | $ | 0.36 | $ | 0.20 | $ | 0.87 | ||||
Shares used in computation of basic net income per share | 6,343,356 | 6,354,135 | 6,339,930 | 6,324,168 | ||||||||
Shares used in computation of diluted net income per share | 6,971,687 | 7,174,568 | 6,984,258 | 7,158,024 |
BioSpecifics Technologies Corp.
Selected Consolidated
Balance Sheet Data
(Unaudited)
June 30, | December 31, | |||||
2012 | 2011 | |||||
Cash and cash equivalents | $ | 3,788,173 | $ | 3,196,831 | ||
Short term investments | 5,000,000 | 5,000,000 | ||||
Accounts and income tax receivable, net | 2,871,915 | 3,481,637 | ||||
Deferred tax assets (short and long-term) | 2,631,900 | 3,047,955 | ||||
Deferred royalty buydown | 2,750,000 | 1,250,000 | ||||
Working capital | 11,612,615 | 11,970,264 | ||||
Total assets | 17,486,662 | 16,265,073 | ||||
Long-term liabilities | 241,955 | 276,520 | ||||
Total stockholders' equity | 16,151,219 | 14,872,314 |