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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: INTRODUCTORY COMMENT Throughout this Current Report on
Form 8-K, the terms "we," "us," "our" and "Company" refer to BioSpecifics
Technologies Corp. On May 7, 2010,
the Company announced its financial and operating results for the fiscal quarter
ended March 31, 2010. 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. 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. EXHIBIT INDEX Exhibit 99.1 BioSpecifics Technologies Corp. Reports First Quarter 2010
Financial Results LYNBROOK, N.Y., May 7 -- BioSpecifics Technologies Corp. (Nasdaq:
BSTC; the "Company"), a biopharmaceutical company developing first in class
collagenase-based products, today announced its financial results for the first
quarter ended March 31, 2010. The Company also highlighted key commercial and
regulatory progress during the quarter, and provided its expected milestones for
the remainder of 2010. "The first quarter of 2010 was a very exciting time here at
BioSpecifics. The approval of XIAFLEX by the U.S. FDA for the treatment of
Dupuytren's contracture was truly game changing for us," stated Thomas Wegman,
President of BioSpecifics. "We look forward to the execution of a successful
marketing and sales effort for this novel treatment option for Dupuytren's
patients and we are also excited to support the further clinical development of
XIAFLEX for additional indications, in particular, the anticipated commencement
of a U.S. Phase 3 Peyronie's disease trial in the second half of this year." Financial Results The Company reported a net loss of $0.3 million for the
quarter ended March 31, 2010, or $0.04 per basic and diluted common share,
compared to a net loss of $0.9 million, or $0.16 per basic and diluted common
share, for the same period in 2009. Total revenues for the quarter ended March 31, 2010 were $2.7
million as compared to $0.3 million for the same period in 2009. The increase in
revenues was mainly attributable to the recognition of two milestone payments
received: $1.3 million from the Company's partner Auxilium Pharmaceuticals, Inc.
("Auxilium") in respect to the commencement of the scientific/technical review
procedure of the Marketing and Authorization Application ("MAA") for XIAFLEX
for Dupuytren's contracture in Europe; and $0.85 million related to the approval
by the U.S. Food and Drug Administration ("FDA") of XIAFLEX for Dupuytren's
contracture in February 2010. In addition, due to the U.S. approval of XIAFLEX
for Dupuytren's contracture, the Company recognized the remaining portion of the
original licensing fee allocated to this indication. For clarification, the
amounts recognized under royalties represent the estimated earn-out revenue
under the Company's agreement with DFB Biotech, Inc. and its affiliates. Research and development expenses for the quarter ended March
31, 2010 were $0.9 million, compared to $0.1 million for the same period in
2009. This increase in research and development expenses was primarily due to
third party development costs that were reimbursable under the Company's
agreement with Auxilium. General and administrative expenses for the quarter ended
March 31, 2010 totaled $2.0 million, compared to $1.2 million for the same
period in 2009. The increase in general and administrative expenses was
primarily due to outside legal fees, stock-based compensation, consulting and
outside services related to investor relations. As of March 31, 2010, BioSpecifics held cash, cash
equivalents and short-term investments of $11.3 million, compared to $8.5
million on December 31, 2009. First Quarter and Recent 2010 Highlights In January 2010,
Auxilium announced that Pfizer, Inc., its European licensee for XIAFLEX,
received notification from the European Medicines Agency that the MAA for
XIAFLEX for the treatment of Dupuytren's contracture completed the validation
phase successfully and the scientific/technical review procedure had
commenced. BioSpecifics received a $1.3 million milestone payment. In February
2010, XIAFLEX received U.S. marketing approval from the FDA for the treatment
of Dupuytren's contracture in adult patients with a palpable cord.
BioSpecifics received an $850,000 milestone payment with an additional
$150,000 still pending. With that approval, XIAFLEX became the first and only
FDA-approved nonsurgical treatment for Dupuytren's contracture. In March 2010,
XIAFLEX became available by prescription in the U.S. for the treatment of
adult Dupuytren's contracture patients with a palpable cord. In March 2010, the Company announced that
its Board of Directors had scheduled its Annual Meeting of Stockholders to be
held on Thursday, June 17, 2010 to consider among other items a proposal to
increase the number of authorized shares of common stock in order to
effectuate a two-for-one forward stock split to allow for additional
liquidity. In its quarterly financial results press
release issued on May 3, 2010, the Company's partner Auxilium reported that as
of the end of April 2010, over 1,100 physicians had attested to completing the
required training through XIAFLEX Xperience and were eligible to use XIAFLEX
for the treatment of Dupuytren's contracture. Additionally, three of the ten
Medicare Administrative Contractors ("MAC") that manage claims processing
across the MAC jurisdictions in the U.S. had issued final guidelines on
covering XIAFLEX and two large commercial insurers, Aetna and HealthNet, had
issued guidelines on covering XIAFLEX. 2010 Upcoming Milestones Following are the Company's
upcoming milestones for 2010: Auxilium plans
to meet with the FDA in the second quarter of 2010 to discuss the Phase 2b
results of XIAFLEX to treat Peyronie's disease. Assuming a successful meeting,
Auxilium expects a U.S. Phase 3 study of XIAFLEX in Peyronie's disease to
begin in the second half of 2010. There will be a
presentation at the American Urological Association (AUA) 2010 Annual Meeting
on June 1, 2010 on the Phase 2b results entitled: Improvement in Penile
Curvature and a Patient Reported Outcome Endpoint in Patients with Peyronie's
Disease: Results from a Phase II Study of Collagenase Clostridium Histolyticum.
BioSpecifics
expects to initiate a clinical trial for injectable collagenase in a new
indication in the second half of 2010. Auxilium stated that it plans to "prioritize
the development of additional pipeline indications for XIAFLEX" in the
remainder of 2010. Conference Call The Company will be hosting a conference call to discuss
these financial results and provide a corporate update today, May 7, 2010, at
8:30 am EDT. In order to participate, please dial 800-860-2442 (domestic) or
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
http://www.biospecifics.com, or use the link:
http://www.videonewswire.com/event.asp?id=68879.
A replay of the call will be available one hour after the
conference call ends on May 7, 2010 until 9:00 am EDT on May 15, 2010. To access
the replay, please dial 877-344-7529 (domestic) or 412-317-0088 (international)
and reference the access code 440390. 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 gained 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 the Company may be found on its website at
www.biospecifics.com. 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 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
BioSpecifics and by its partner Auxilium regarding XIAFLEX as a major
breakthrough for patients with Dupuytren's contracture; the distribution network
for XIAFLEX; the number of patients with Dupuytren's contracture in the U.S.;
the ability to obtain regulatory approval of XIAFLEX in the U.S. for Peyronie's
disease and the ability of Pfizer to obtain regulatory approval of XIAFLEX in
its territory for Dupuytren's contracture and Peyronie's disease, which will
determine the amount of milestone, royalty and sublicense income payments it may
receive; the amount of earn out payments it may receive from DFB Biotech, Inc.
and its affiliates; whether Auxilium exercises its option under the Company's
license and development agreement for additional indications; the potential
benefits of its existing license and development agreements; its estimates
regarding expenses, future revenue, capital requirements and needs for
additional financing; 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. 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 Corp.
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): May 7, 2010
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)
[ ]
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))
ITEM 2.02
RESULTS OF OPERATIONS AND
FINANCIAL CONDITION
ITEM 9.01.
FINANCIAL STATEMENTS AND EXHIBITS
(d)
Exhibits
99.1
Press release dated May 7, 2010
Date: May 7, 2010
BIOSPECIFICS TECHNOLOGIES CORP.
(Registrant)
/s/ Thomas L. Wegman
Thomas L. Wegman
President
Exhibit No.
Description
99.1
Press
release dated May 7, 2010
Consolidated Statements of Operations
Three months ended | ||||
March 31, | ||||
2010 | 2009 | |||
Revenues: | ||||
Net sales | $ |
8,936 |
$ |
7,191 |
Royalties |
31,812 |
- |
||
Licensing fees |
2,548,284 |
266,281 |
||
Consulting fees |
70,000 |
70,000 |
||
Total Revenues |
2,659,032 |
343,472 |
||
|
|
|||
Costs and expenses: |
|
|
||
Research and development |
896,817 |
115,871 |
||
General and administrative |
2,034,178 |
1,166,971 |
||
Total costs and expenses |
2,930,995 |
1,282,842 |
||
Operating loss | (271,963) | (939,370) | ||
Other income (expense): | ||||
Interest Income |
25,850 |
2,857 |
||
Other, net |
- |
(9,463) | ||
25,850 |
(6,606) | |||
Loss before income tax | (246,113) | (945,976) | ||
Income tax expense | (8,067) | - |
Net loss | $ | (254,180) | $ | (945,976) |
Basic and diluted net loss per share | $ | (0.04) | $ | (0.16) |
Shares used in computation of basic and diluted net loss per share |
6,213,995 |
6,008,834 |
||
BioSpecifics Technologies Corp.
Selected Consolidated Balance Sheet Data
(Unaudited)
March 31, | December 31, | |||
2010 | 2009 | |||
Cash and cash equivalents | $ | 6,733,620 | $ | 3,950,389 |
Short term investments | 4,548,541 | 4,548,541 | ||
Accounts and income tax receivable, net | 646,157 | 1,712,220 | ||
Working capital | 6,227,088 | 5,768,760 | ||
Total assets | 13,466,053 | 11,748,478 | ||
Long-term liabilities | 1,041,447 | 1,150,721 | ||
Total stockholders' equity | 6,649,795 | 6,092,107 | ||
CONTACT: Thomas Wegman, President, +1-516-593-7000