-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, QfJ6mr0k7omRn10brq///oTeBaMbmkbLb7iS8W6ZztsM4tpBbKz18Mkuon23P7h6 fqzIxKSxyJ47DwWnGg/cWg== 0001204459-09-001440.txt : 20090813 0001204459-09-001440.hdr.sgml : 20090813 20090812181607 ACCESSION NUMBER: 0001204459-09-001440 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20090630 FILED AS OF DATE: 20090813 DATE AS OF CHANGE: 20090812 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOSPECIFICS TECHNOLOGIES CORP CENTRAL INDEX KEY: 0000875622 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 113054851 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-34236 FILM NUMBER: 091008048 BUSINESS ADDRESS: STREET 1: 35 WILBUR ST CITY: LYNBROOK STATE: NY ZIP: 11563 BUSINESS PHONE: 5165937000 MAIL ADDRESS: STREET 1: 35 WILBUR STREET CITY: LYNBROOK STATE: NY ZIP: 11563 10-Q 1 btc10q.htm FORM 10-Q BioSpecifics Technologies Corp.: Form 10-Q - Prepared by TNT FIlings Inc.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2009

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________________ to __________________

0-19879
(Commission file number)

BIOSPECIFICS TECHNOLOGIES CORP.
(Exact Name of Registrant as Specified in Its Charter)

Delaware 11-3054851
(State or Other Jurisdiction (I.R.S. Employer
of Incorporation or Organization) Identification No.)

35 Wilbur Street Lynbrook, NY 11563
(Address of Principal Executive Offices) (Zip Code)

516.593.7000
(Registrant’s Telephone Number, Including Area Code)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes x             No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer o Accelerated filer o
       
Non-accelerated filer o (Do not check if a smaller reporting company) Smaller reporting company x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes o             No x

Indicate the number of shares outstanding of the issuer's classes of common stock, as of the latest practicable date:

Class of Stock Outstanding August 7, 2009
Common Stock ($.001 par value) 6,081,551


BIOSPECIFICS TECHNOLOGIES CORP.

TABLE OF CONTENTS

    Page
  PART I – FINANCIAL INFORMATION  
ITEM 1. Consolidated Financial Statements 3
  Consolidated Balance Sheet as of June 30, 2009 and December 31, 2008 3
Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2009 and 2008 4
Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2009 and 2008 5
  Notes to Consolidated Financial Statements 6
ITEM 2. Management’s Discussion and Analysis 15
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk 22
ITEM 4T. Controls and Procedures 22


PART II – OTHER INFORMATION

ITEM 1. Legal Proceedings 23
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 23
ITEM 3. Defaults Upon Senior Securities 23
ITEM 4. Submission of Matters to a Vote of Security Holders 23
ITEM 5. Other Information 24
ITEM 6. Exhibits 24


Introductory Comments – Terminology

Throughout this quarterly report on Form 10-Q (this “Report”), the terms “BioSpecifics,” “Company,” “we,” “our,” and “us” refer to BioSpecifics Technologies Corp. and its subsidiary, Advance Biofactures Corporation (“ABC-NY”).

Introductory Comments – Forward-Looking Statements

This Report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward-looking statements” for purposes of these provisions, including any projections of earnings, revenues or other financial items, any statements of the plans and objectives of management for future operations, any statements concerning proposed new products or licensing or collaborative arrangements, any statements regarding future economic conditions or performance, and any statement of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” estimates,” “potential,” or “continue” or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained in this Report are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including but not limited to the risk factors set forth below, and for the reasons described elsewhere in this Report. All forward-looking statements and reasons why results may differ included in this Report are made as of the date hereof, and we assume no obligation to update these forward-looking statements or reasons why actual results might differ.


PART I – FINANCIAL INFORMATION

Item 1: Consolidated Financial Statements

BIOSPECIFICS TECHNOLOGIES CORP.
Consolidated Balance Sheets

    June 30,     December 31,  
             
    2009     2008  
    (unaudited)     (audited)  
Assets            
Current assets:            
   Cash and cash equivalents $  9,324,499   $  3,494,150  
   Short-term investments   499,379     900,000  
   Accounts receivable, net   874,673     6,952,781  
   Prepaid expenses and other current assets   135,263     67,709  
Total current assets   10,833,814     11,414,640  

   Deferred royalty buy-down


1,250,000



1,250,000

   Property, plant and equipment, net   1,453     2,297  
   Patent costs, net   201,976     164,424  

Total assets


12,287,243



12,831,361


Liabilities and Stockholders' Equity






Current liabilities:            
   Accounts payable and accrued expenses   505,501     642,465  
   Deferred revenue   1,174,785     1,271,792  
   Accrued liabilities of discontinued operations   78,138     78,138  
Total current liabilities   1,758,424     1,992,395  

   Accrued third-party development expenses


2,842,262



2,758,595

   Long-term deferred revenue   1,526,277     1,901,832  

Stockholders' equity:






   Series A Preferred stock, $.50 par value, 700,000 shares authorized; none outstanding   -     -  
   Common stock, $.001 par value; 10,000,000 shares authorized; 6,168,518 shares and
      6,140,068 shares issued and outstanding at June 30, 2009 and December 31, 2008,
      respectively




6,169






6,140


   Additional paid-in capital   14,310,300     13,294,803  
   Accumulated deficit   (7,462,232 )   (6,428,447 )
   Treasury stock, 131,267 shares at cost at June 30, 2009 and December 31, 2008   (693,957 )   (693,957 )
Total stockholders' equity   6,160,280     6,178,539  

Total liabilities and stockholders’ equity

$

12,287,243


$

12,831,361

See accompanying notes to consolidated financial statements


BIOSPECIFICS TECHNOLOGIES CORP.
Consolidated Statements of Operations
(unaudited)

    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2009     2008     2009     2008  
Revenues:                        
   Net sales $  9,914   $  4,046   $  17,105   $  16,799  
   Royalties   375,400     2,028     375,400     2,028  
   Licensing fees   766,281     266,282     1,032,562     532,563  
   Consulting fees   70,000     162,000     140,000     284,185  
         Total Revenues   1,221,595     434,356     1,565,067     835,575  

Costs and expenses:












   Research and development   124,192     94,432     240,063     188,703  
   General and administrative   1,140,485     1,173,316     2,307,456     1,973,772  
         Total Cost and Expenses   1,264,677     1,267,748     2,547,519     2,162,475  

Operating loss


(43,082

)


(833,392

)


(982,452

)


(1,326,900

)

Other income (expense):












   Interest income   1,688     27,528     4,545     57,803  
   Interest expense   (39 )   -     (39 )   (451 )
   Other, net   -     4,527     (9,463 )   4,527  
    1,649     32,055     (4,957 )   61,879  

Loss before benefit (expense) for income tax


(41,433

)


(801,337

)


(987,409

)


(1,265,021

)
   Income tax benefit (expense)   (46,376 )   -     (46,376 )   -  

Net loss

$

(87,809

)

$

(801,337

)

$

(1,033,785

)

$

(1,265,021

)


Basic and diluted net loss per share


$


(0.01


)


$


(0.14


)


$


(0.17


)


$


(0.22


)

Shares used in computation of basic and diluted net loss per share


6,014,312



5,796,764



6,011,588



5,715,825

See accompanying notes to consolidated financial statements

4


BioSpecifics Technologies Corp.
Consolidated Statements of Cash Flows

    Six Months Ended  
    June 30,  
Cash flows from operating activities:   2009     2008  
   Net loss $  (1,033,785 ) $  (1,265,021 )
   Adjustments to reconcile net loss to net cash used
     in operating activities:






         Gain on disposal of fixed asset   -     (4,527 )
         Depreciation and amortization   16,312     16,074  
         Stock-based compensation expense   882,891     737,791  
   Changes in operating assets and liabilities:            
         Accounts receivable   6,078,109     6,629  
         Prepaid expenses and other current assets   (67,554 )   (28,788 )
         Accounts payable and accrued expenses   (59,942 )   (153,837 )
         Deferred revenue   (472,563 )   (472,562 )
Net provided by (used in) operating activities   5,343,468     (1,164,241 )

Cash flows from investing activities:






   Maturities of marketable securities   900,000     350,000  
   Purchases of marketable securities   (499,379 )   (750,000 )
   Proceeds from sale of fixed asset   -     7,000  
Net cash provided by (used in) investing activities   400,621     (393,000 )

Cash flows from financing activities:






   Proceeds from issuance of capital stock   -     4,882,679  
   Proceeds from stock option exercises   86,260     230,825  
   Proceeds from pay-off of notes receivable from former CEO and Chairman   -     1,116,558  
Net cash provided by financing activities   86,260     6,230,062  

Increase in cash and cash equivalents


5,830,349



4,672,821

Cash and cash equivalents at beginning of year   3,494,150     68,564  
Cash and cash equivalents at end of year $  9,324,499   $  4,741,385  

Supplemental disclosures of cash flow information:






Cash paid during the year for:            
Interest $  -   $  451  
Taxes $  361,228   $  -  

Supplemental disclosures of non-cash transactions:

Under our agreement with Auxilium certain patent costs paid by Auxilium on behalf of the Company are creditable against future royalties. As of June 30, 2009 we accrued $242,301 related to this issue of which $40,325 was amortized in the 2009 period and zero in the 2008 comparable period.

See accompanying notes to consolidated financial statements

5


BIOSPECIFICS TECHNOLOGIES CORP.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2009
(Unaudited)

1. ORGANIZATION AND DESCRIPTION OF BUSINESS

We are a biopharmaceutical company involved in the development of an injectable collagenase for multiple indications. We have a development and license agreement with Auxilium Pharmaceuticals, Inc. (“Auxilium”) for injectable collagenase (which Auxilium has named “XIAFLEX TM” (formerly known as “AA4500”)) for clinical indications in Dupuytren’s disease, Peyronie’s disease and frozen shoulder (adhesive capsulitis), and Auxilium has an option to acquire additional indications that we may pursue, including cellulite and lipomas.

The most advanced indications are for the treatment of Dupuytren’s disease, Peyronie’s disease and frozen shoulder. On June 3, 2004, we entered into a development and license agreement with Auxilium, as amended on May 10, 2005 and December 15, 2005, respectively (the “Prior Auxilium Agreement”), pursuant to which we granted to Auxilium an exclusive worldwide license to develop products containing our injectable collagenase for the treatment of Dupuytren’s disease, Peyronie's disease and frozen shoulder, as well as an exclusive option to develop and license the technology for use in additional indications other than dermal formulations labeled for topical administration.

On December 11, 2008, the parties amended and restated the development and license agreement (the “Auxilium Agreement”), which became effective on December 17, 2008 upon the execution and effectiveness of the Development, Commercialization and Supply Agreement, dated December 17, 2008 (the “Pfizer Agreement”) between Auxilium International Holdings, Inc., a wholly owned subsidiary of Auxilium, and Pfizer, Inc. (“Pfizer”), pursuant to which Pfizer will market XIAFLEX for the treatment of Dupuytren’s disease and Peyronie’s disease in Europe and various other territories. The Auxilium Agreement amends and restates in its entirety the Prior Auxilium Agreement.

On April 28, 2009, Auxilium announced that the U.S. Food and Drug Administration (the “FDA”) has accepted for filing and granted priority review status to its Biologics License Application (“BLA”) for XIAFLEX. On June 18, 2009, Auxilium announced that the FDA Arthritis Advisory Committee will review XIAFLEX during an advisory committee hearing, tentatively scheduled to take place on September 16, 2009 and that the FDA has not updated the Prescription Drug User Fee Act date of August 28, 2009. On July 31, 2009 Auxilium announced that the FDA Arthritis Advisory Committee confirmed it will review XIAFLEX during an advisory committee hearing in Gaithersburg, MD on September 16, 2009. A notice announcing the meeting was published in the Federal Register on July 31, 2009.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying consolidated financial statements are unaudited, but include all adjustments (consisting only of normal, recurring adjustments) which we consider necessary for a fair presentation of our financial position at such dates and the operating results and cash flows for those periods. Although we believe that the disclosures in our financial statements are adequate to make the information presented not misleading, certain information normally included in financial statements prepared in accordance with accounting principles generally accepted (“GAAP”) in the United States (the “U.S.”) has been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for quarterly reporting.

6


The information included in this Report should be read in conjunction with our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2009 filed with the SEC on May 12, 2009 and our Annual Report on Form 10-K for the year ended December 31, 2008 filed with the SEC on March 31, 2009.

Principles of Consolidation

The unaudited consolidated financial statements include the accounts of the Company and its subsidiary, ABC-NY.

Management Estimates

The preparation of unaudited consolidated financial statements in conformity with accounting principles generally accepted in the U.S. requires the use of management’s estimates and assumptions that affect the amounts reported in the unaudited consolidated financial statements and accompanying notes. Actual results could differ from those estimates.

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities are stated at market value. Cash equivalents include only securities having a maturity of three months or less at the time of purchase. The Company limits its credit risk associated with cash, cash equivalents and marketable securities by placing its investments with banks it believes are highly creditworthy.

Fair Value Measurements

SFAS 157 requires expanded disclosures about fair value measurements. SFAS 157 applies to other accounting pronouncements that require or permit fair value measurements, but does not require any new fair value measurements. We adopted the provisions of SFAS 157 relating to assets and liabilities recognized or disclosed in the financial statements at fair value on a recurring basis on January 1, 2008. The adoption of these provisions did not have a material effect on our consolidated financial statements.

SFAS 157 clarifies that fair value is an exit price, representing the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants based on the highest and best use of the asset or liability. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. SFAS 157 requires us to use valuation techniques to measure fair value that maximize the use of observable inputs and minimize the use of unobservable inputs. These inputs are prioritized as follows:

  • Level 1: Observable inputs such as quoted prices for identical assets or liabilities in active markets
  • Level 2: Other inputs that are observable directly or indirectly, such as quoted prices for similar assets or liabilities or market-corroborated inputs
  • Level 3: Unobservable inputs for which there is little or no market data and which require us to develop our own assumptions about how market participants would price the assets or liabilities

The following table sets forth the fair value of our financial assets that were measured on a recurring basis as of June 30, 2009:

7



    Level 1     Level 2     Level 3  
Cash and cash equivalents $  9,324,499     -     -  
U.S Treasuries   499,379     -     -  

Auction Rate Securities

As of June 30, 2009 we held no taxable auction rate securities, or ARS. As of December 31, 2008, we held $0.9 million of ARS, which were classified as short-term investments. On January 5, 2009, we received the remaining principal balance of our investment in auction rate securities of $0.9 million.

Revenue Recognition

We recognize revenues resulting from product sales, royalties, from licensing and use of our technology, and from other services we sometimes perform in connection with the licensed technology under the guidance of Staff Accounting Bulletin (SAB) No. 104, “Revenue Recognition.”

If we determine that separate elements exist in a revenue arrangement under Emerging Issues Task Force Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables” (EITF 00-21), we recognize revenue for delivered elements only when the fair values of undelivered elements are known, when the associated earnings process is complete, when payment is reasonably assured and, to the extent the milestone amount relates to our performance obligation, when our customer confirms that we have met the requirements under the terms of the agreement.

Revenues, and their respective treatment for financial reporting purposes, are as follows:

Product Sales

We recognize revenue from product sales when there is persuasive evidence that an arrangement exists, title passes, the price is fixed or determinable and collectability is reasonably assured. No right of return exists for our products except in the case of damaged goods. To date, we have not experienced any significant returns of our products.

Net sales include the sales of the API Enzyme that are recognized at the time the product is shipped to customers for laboratory use.

Royalty/Earn-Out Revenue

We recognize royalties under the earn-out provision of the Asset Purchase Agreement with DFB. We have the right to receive earn out payments in the future based on sales of certain products. Generally, under this agreement we would receive royalty payments and a report within ninety (90) days from the end of each calendar year after the licensee has sold the royalty-bearing product. Our right to receive earn out payments under our agreement with DFB will expire in 2013. We recognize royalty revenues when we can reliably estimate such amounts and collectability is reasonably assured.

8


License and Sublicense Fees

We include revenue recognized from upfront licensing, sublicensing and milestone payments in “License Fees” in our consolidated statements of operations in this Report.

Upfront License and Sublicensing Fees

We generally recognize revenue from upfront licensing and sublicensing fees when the agreement is signed, we have completed the earnings process and we have no ongoing performance obligation with respect to the arrangement. Nonrefundable upfront technology license for product candidates for which we are providing continuing services related to product development are deferred and recognized as revenue over the development period.

Milestones

Milestones, in the form of additional license fees, typically represent nonrefundable payments to be received in conjunction with the achievement of a specific event identified in the contract, such as completion of specified development activities and/or regulatory submissions and/or approvals. We believe that a milestone represents the culmination of a distinct earnings process when it is not associated with ongoing research, development or other performance on our part. We recognize such milestones as revenue when they become due and collection is reasonably assured. When a milestone does not represent the culmination of a distinct earnings process, we recognize revenue in a manner similar to that of an upfront license fee.

The timing and amount of revenue that we recognize from licenses of technology, either from upfront fees or milestones where we are providing continuing services related to product development, is primarily dependent upon our estimates of the development period. We define the development period as the point from which research activities commence up to regulatory approval of either our, or our partners’ submission assuming no further research is necessary. As product candidates move through the development process, it is necessary to revise these estimates to consider changes to the product development cycle, such as changes in the clinical development plan, regulatory requirements, or various other factors, many of which may be outside of our control. Should the FDA or other regulatory agencies require additional data or information, we would adjust our development period estimates accordingly. The impact on revenue of changes in our estimates and the timing thereof is recognized prospectively over the remaining estimated product development period.

Consulting and Technical Assistance Services

We recognize revenues from a consulting and technical assistance contracts primarily as a result of our agreements with DFB and Auxilium. Consulting revenues are recognized ratably over the term of the contract. The consulting obligations to DFB generally expire during March 2011.

Reimbursable Third Party Development Costs

We accrue expenses to research and development for estimated third party development costs and capitalize certain patent costs that are reimbursable under our agreement with Auxilium. Estimates are based on contractual terms, historical development costs, reviewing third party data and expectations regarding future development for certain products. Further, we monitor the activities and clinical trials of our development partners.

If conditions or other circumstances change, we may take actions to revise our reimbursable third party development cost estimates. These revisions could result in an incremental increase in research and development costs. For example, the Auxilium Agreement provides that Auxilium and BioSpecifics will share equally in third party costs for the development of the lyophilization of the injection formulation and certain patent fees.

9


On July 13, 2009, we received an updated invoice from Auxilium for approximately $37,000 increasing the total amount due that Auxilium believes is owed by us to approximately $2.84 million through June 30, 2009 under this provision. The increase in the second quarter was primarily due to patent and related legal fees. Based upon the updated invoice, we recorded an additional liability of $37,000 for reimbursable third party patent expenditures.

Based on our preliminary review, we believe that only a portion of the amount charged actually relates to the development of the lyophilization of the injection formulation as well as for patent and related legal fees and, therefore, reserve all rights related to this matter, including but not limited to our right to contest the amount charged by Auxilium.

Actual results have differed in the past, and may differ in the future, from our estimates and could impact our earnings in any period during which an adjustment is made.

Research and Development Expenses

Our research and development (“R&D”) costs are expensed as incurred. R&D includes, but is not limited to, internal costs, such as salaries and benefits, costs of materials, lab expense, facility costs and overhead. R&D also consists of third-party costs, such as medical professional fees, contract manufacturing costs for material used in clinical trials, consulting fees and costs associated with clinical study R&D arrangements. We may fund R&D at medical research institutions under agreements that are generally cancelable. All of these costs are charged to R&D as incurred, which may be measured by percentage of completion, contract milestones, patient enrollment, or the passage of time.

Clinical Trial Expenses

Our cost accruals for clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with various clinical trial centers and clinical research organizations. In the normal course of business we contract with third parties to perform various clinical trial activities in the ongoing development of potential drugs. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients, the completion of portions of the clinical trial, or similar conditions. The objective of our accrual policy is to match the recording of expenses in our financial statements to the actual cost of services received and efforts expended. As such, expenses related to each patient enrolled in a clinical trial are recognized ratably beginning upon entry into the trial and over the course of the patient’s continued participation in the trial. In the event of early termination of a clinical trial, we accrue an amount based on our estimate of the remaining non-cancelable obligations associated with the winding down of the clinical trial. Our estimates and assumptions could differ significantly from the amounts that may actually be incurred.

Stock-Based Compensation

Under the provisions of Statement of Financial Accounting Standards (SFAS) No. 123(R), we estimate the fair value of our employee stock awards at the date of grant using the Black-Scholes option-pricing model, which requires the use of certain subjective assumptions. The most significant of these assumptions are our estimates of the expected volatility of the market price of our stock and the expected term of the award. When establishing an estimate of the expected term of an award, we consider the vesting period for the award, our recent historical experience of employee stock option exercises (including forfeitures) and the expected volatility. When there is uncertainty in the factors used to determine expected term, we use the simplified method in accordance with SEC Staff Accounting Bulletin 107. As required under the accounting rules, we review our valuation assumptions at each grant date and, as a result, our valuation assumptions used to value employee stock-based awards granted in future periods may change. The weighted-average assumptions used were as follows:

10



  Six Months Ended
  June 30,
  2009
Stock Option Plans  
Expected life, in years 5.0
Risk free interest rate 2.4%
Volatility 59%
Dividend yield

Further, SFAS 123(R) requires that employee stock-based compensation costs to be recognized over the requisite service period, or the vesting period, in a manner similar to all other forms of compensation paid to employees. The allocation of employee stock-based compensation costs to each operating expense line are estimated based on specific employee headcount information at each grant date and estimated stock option forfeiture rates and revised, if necessary, in future periods if actual employee headcount information or forfeitures differ materially from those estimates. As a result, the amount of employee stock-based compensation costs we recognize in each operating expense category in future periods may differ significantly from what we have recorded in the current period.

Stock-based compensation expense recognized under SFAS 123(R) was as follows:

    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2009     2008     2009     2008  
Research and development $  29,728   $  4,979   $  43,644   $  9,957  
General and administrative   423,576     574,234     839,247     727,834  
   Total stock-based
      compensation expense

$

453,304


$

579,213


$

882,891


$

737,791

Stock Option Activity

A summary of our stock option and warrant activity during the six months ended June 30, 2009 is presented below:

    Total Number     Weighted-Average  
Option   of Shares     Exercise Price  
Outstanding as of December 31, 2008   1,477,100   $ 4.82  
Granted   55,000     18.96  
Forfeited   -     -  
Exercised   (28,450 ) $ 3.12  
Expired   -     -  
Outstanding as of June 30, 2009   1,503,650   $ 5.37  

Exercisable as of June 30, 2009


1,282,400


$

4.02

During the second quarter of 2009, the Company granted 40,000 stock options to its employees with a four year vesting period at an exercise price of $18.21 and 15,000 stock options to a director with a one year vesting period at an exercise price of $20.95. The total number of outstanding options as of June 30, 2009 was 1,503,650.

11


The weighted-average grant-date fair value for options granted during the six months ended June 30, 2009 and 2008 was $18.96 and $14.19 per share respectively. During the six months ended June 30, 2009 and 2008, $86,260 and $230,825 were received from stock options exercised by option holders, respectively.

The aggregate intrinsic value of options outstanding and exercisable as of June 30, 2009 was approximately $25.4 million. Aggregate intrinsic value represents the total pre-tax intrinsic value, based on the closing price of our common stock of $23.83 on June 30, 2009, which would have been received by the option holders had all option holders exercised their options as of that date. Total unrecognized compensation cost related to non-vested stock options outstanding as of June 30, 2009 was approximately $1.5 million which we expect to recognize over a weighted-average period of 1.5 years.

Property, Plant and Equipment

Property, plant and equipment are stated at cost, less accumulated depreciation. Machinery and equipment, furniture and fixtures, and autos are depreciated on the straight-line basis over their estimated useful lives of 5 to 10 years. Leasehold improvements are being amortized over the lesser of their estimated useful lives or the remaining life of the lease, which is approximately 1 year.

Recent Accounting Pronouncements

We adopted Financial Accounting Standards No. 165, Subsequent Events (FAS 165), in the second quarter of 2009. FAS 165 establishes the accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued or are available to be issued. It requires the disclosure of the date through which an entity has evaluated subsequent events and the basis for that date, that is, whether that date represents the date the financial statements were issued or were available to be issued. The adoption of FAS 165 did not have a material impact on our consolidated financial statements.

In June 2009, the FASB issued Statement of Financial Accounting Standard (SFAS) No. 168, The FASB Accounting Standard Codification and the Hierarchy of the Generally Accepted Accounting Principles — a replacement of SFAS No. 162 (SFAS 168), to become the source of authoritative U.S. generally accepted accounting principles (“GAAP”) recognized by the FASB to be applied by nongovernmental entities. SFAS 168 is effective for financial statements issued for interim and annual periods ending after September 15, 2009. We do not believe the adoption of SFAS 168 will have a material impact on our consolidated financial statements.

3. NET LOSS PER SHARE

In accordance with SFAS No. 128, “Earnings Per Share” (SFAS 128), basic net loss per share amount is computed using the weighted-average number of shares of common stock outstanding during the periods presented, while diluted net loss per share is computed using the sum of the weighted-average number of common and common equivalent shares outstanding. Common equivalent shares used in the computation of diluted earnings per share result from the assumed exercise of stock options using the converted method. For the three and six months ended June 30, 2009 and 2008, we incurred a net loss from continuing operations and, as such, we did not include the effect of outstanding stock options in the diluted net loss per share calculations, as their effect would have been anti-dilutive.

The following table summarizes the number of common equivalent shares excluded from the calculation of diluted net loss per share from continuing operations reported in the consolidated statement of operations as their effect would have been anti-dilutive:

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    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2009     2008     2009     2008  
Stock options   1,014,917     1,260,813     1,017,570     1,248,372  

4. TOTAL COMPREHENSIVE INCOME (LOSS)

Comprehensive loss is comprised of net loss and other comprehensive income. Specifically, we include in other comprehensive income the changes in unrealized gains and losses on our holdings of available-for-sale securities, which are excluded from our net loss. The following table presents the calculation of our comprehensive income (loss):

    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2009     2008     2009     2008  
   Net loss $  87,809   $  801,337   $  1,033,785   $  1,265,021  
Other comprehensive loss:                        
   Change in unrealized losses on marketable securities   -     142,184     -     354,572  
         Total Comprehensive Loss $  87,809   $  943,521   $  1,033,785   $  1,619,593  

5. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consisted of the following:

    June 30,     December 31,  
    2009     2008  
Trade accounts payable and accrued expenses $  329,837   $  409,433  
Accrued legal and other professional fees   46,385     117,837  
Accrued payroll and related costs   129,279     115,195  

         Total

$

505,501


$

642,465

6. PATENT COSTS

We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, ranging from 5 to 13 years, and review for impairment on a quarterly basis and when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable.

As of June 30, 2009, the Company capitalized certain patent costs, paid by Auxilium on behalf of the Company. These costs are reimbursable to Auxilium under our agreement and are creditable against future royalty revenues. Net patent costs consisted of:

    June 30,     December 31,  
    2009     2008  
Patents $  201,976   $  164,424  

The amortization expense for patents was $15,469, for the six months ended June 30, 2009 and zero for the 2008 period. The estimated aggregate amortization expense for each of the next five years is approximately as follows:

2010 $31,000
2011 31,000
2012 29,000
2013 27,000
2014 27,000

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7. INCOME TAXES

Deferred tax assets and liabilities are recognized based on the expected future tax consequences, using current tax rates, of temporary differences between the financial statement carrying amounts and the income tax basis of assets and liabilities. A valuation allowance is applied against any net deferred tax asset if, based on the weighted available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

We account for uncertain tax positions that meet “a more likely than not” threshold in accordance with FASB Interpretation No. 48, Accounting for Uncertain Tax Positions, which requires us to recognize the benefit of uncertain tax positions in our financial statements.

8. RELATED PARTY TRANSACTIONS

On February 1, 2008, the Estate of Edwin H. Wegman (the “Estate”) sold an aggregate of 344,114 shares of the Company's common stock, par value $0.001, at a purchase price of $12.00 per share to certain private investors. The Estate used certain of the proceeds of the transaction to repay the loan owed to the Company by Edwin H. Wegman, our former Chairman and CEO. The total loan repayment amount was $1,116,558, which represents the principal amount of $625,774 owed to the Company and accrued interest through January 31, 2008 of $490,784.

As previously reported, Advance Biofactures Corp. (“ABC”, and together, with the Company, the “Tenant”), a wholly owned subsidiary of the Company, and Wilbur St. Corp. (the “Landlord”), entered into a Commercial Lease Agreement on January 30, 1998 (the “Commercial Lease Agreement”), pursuant to which the Landlord leased to ABC the premises located at 35 Wilbur Street, Lynbrook, NY 11563 (the “Premises”) for a term of 7 years or until January 31, 2005 and for an annual rental price of $125,000.

As previously reported, the Tenant, without the approval of the board of directors of the Company, and the Landlord entered into an Extension and Modification Agreement on July 1, 2005 (the “Modification Agreement” and together with the Commercial Lease Agreement, the “Lease Agreement”), pursuant to which the term of the Commercial Lease Agreement was extended for an additional 5 years or until June 30, 2010 and the annual rental price for the Premises increased to $150,000.

In connection with the settlement of the previously reported dispute between the Tenant and the Landlord regarding payments of amounts due under the Modification Agreement, the parties entered into a Lease Modification Agreement dated June 22, 2009 and effective as of June 24, 2009 (the “LMA”). Pursuant to the LMA, the Tenant ratified the Lease Agreement, including the Modification Agreement, subject to the terms thereof, and agreed to a $15,000 reduction in the annual rental price of the Premises to $135,000.

The foregoing description of the LMA does not purport to be complete and is qualified in its entirety by reference to the full text of the agreement, which was filed as Exhibit 10.1 to our Current Report on Form 8-K on June 29, 2009.

9. SUBSEQUENT EVENTS

None

Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion should be read in conjunction with the consolidated financial statements and related notes thereto included elsewhere in this Report.

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Overview

We are a biopharmaceutical company involved in the development of an injectable collagenase for multiple indications. We have a development and license agreement with Auxilium Pharmaceuticals, Inc. (“Auxilium”) for injectable collagenase (which Auxilium has named “XIAFLEX TM” (formerly known as “AA4500”)) for clinical indications in Dupuytren’s disease, Peyronie’s disease and frozen shoulder (adhesive capsulitis), and Auxilium has an option to acquire additional indications that we may pursue, including cellulite and lipomas.

The most advanced indications are for the treatment of Dupuytren’s disease, Peyronie’s disease and frozen shoulder. On June 3, 2004, we entered into a development and license agreement with Auxilium, as amended on May 10, 2005 and December 15, 2005, respectively (the “Prior Auxilium Agreement”), pursuant to which we granted to Auxilium an exclusive worldwide license to develop products containing our injectable collagenase for the treatment of Dupuytren’s disease, Peyronie's disease and frozen shoulder, as well as an exclusive option to develop and license the technology for use in additional indications other than dermal formulations labeled for topical administration.

On December 11, 2008, the parties amended and restated the development and license agreement (the “Auxilium Agreement”), which became effective on December 17, 2008 upon the execution and effectiveness of the Development, Commercialization and Supply Agreement, dated December 17, 2008 (the “Pfizer Agreement”) between Auxilium International Holdings, Inc., a wholly owned subsidiary of Auxilium, and Pfizer, Inc. (“Pfizer”), pursuant to which Pfizer will market XIAFLEX for the treatment of Dupuytren’s disease and Peyronie’s disease in Europe and various other territories. The Auxilium Agreement amends and restates in its entirety the Prior Auxilium Agreement.

On April 28, 2009, Auxilium announced that the U.S. Food and Drug Administration (the “FDA”) has accepted for filing and granted priority review status to its Biologics License Application (“BLA”) for XIAFLEX. On June 18, 2009, Auxilium announced that the FDA Arthritis Advisory Committee will review XIAFLEX during an advisory committee hearing, tentatively scheduled to take place on September 16, 2009 and that the FDA has not updated the Prescription Drug User Fee Act date of August 28, 2009. On July 31, 2009 Auxilium announced that the FDA Arthritis Advisory Committee confirmed it will review XIAFLEX during an advisory committee hearing in Gaithersburg, MD on September 16, 2009. A notice announcing the meeting was published in the Federal Register on July 31, 2009.

Outlook

We foresee the potential to generate income from limited sources in the next several years. Under the terms of our agreement with DFB, we are scheduled to receive certain contractual anniversary payments and, if DFB exceeds a certain sales target, we would be entitled to an earn out on sales. Under the terms of our agreement with Auxilium, we may receive milestone payments upon their achieving certain regulatory progress and if Auxilium elects to pursue additional indications for injectable collagenase (“Additional Indications”) as well as 8.5% of all sublicense income that Auxilium may receive from Pfizer under the Pfizer Agreement.

Based on our current business model, we expect to have adequate cash reserves until at least the first half of 2012 depending on the amount actually owed to Auxilium, as discussed in Item 1A, “Risk Factors”, included in our Annual Report on Form 10-K for the year ended December 31, 2008. As a significant portion of our revenues is tied directly to the success of Auxilium in commercializing XIAFLEX, we cannot reasonably forecast our financial condition beyond this time.

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Significant Risks

In recent history we have had operating losses and may not achieve sustained profitability. As of June 30, 2009 we had an accumulated deficit from continuing operations of $7,462,232.

We are dependent to a significant extent on third parties, and our principal licensee, Auxilium, may not be able to successfully develop products, obtain required regulatory approvals, manufacture products at an acceptable cost, in a timely manner and with appropriate quality, or successfully market products or maintain desired margins for products sold, and as a result we may not achieve sustained profitable operations.

As of June 30, 2009 we held no taxable auction rate securities, or ARS. As of December 31, 2008, we held $0.9 million of ARS, which were classified as short-term investments. On January 6, 2009, we received the remaining principal balance of our investment in auction rate securities of $0.9 million.

Critical Accounting Policies, Estimates and Assumptions

The preparation of unaudited consolidated financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. These estimates are based on historical experience and on various other assumptions that we believe are reasonable under the circumstances. The information at June 30, 2009 and for the three and six months ended June 30, 2009 and 2008 is unaudited but includes all adjustments (consisting only of normal recurring adjustments) which, in the opinion of management, are necessary to state fairly the financial information set forth herein. The December 31, 2008 balance sheet amounts and disclosures included herein have been derived from the Company’s December 31, 2008 audited consolidated financial statements. The interim results are not necessarily indicative of results to be expected for the full fiscal year. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2008 included in the Company’s Form 10-K filed with the SEC on March 31, 2009 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2009. While our significant accounting policies are described in more detail in the notes to our unaudited consolidated financial statements, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our unaudited consolidated financial statements.

Revenue Recognition. We recognize revenues from product sales when there is persuasive evidence that an arrangement exists, title passes, the price is fixed and determinable, and payment is reasonably assured. We currently recognize revenues resulting from the licensing, sublicensing and use of our technology and from services we sometimes perform in connection with the licensed technology.

We enter into product development licenses, and collaboration agreements that may contain multiple elements, such as upfront license and sublicense fees, and milestones related to the achievement of particular stages in product development and royalties. As a result, significant contract interpretation is sometimes required to determine the appropriate accounting, including whether the deliverables specified in a multiple-element arrangement should be treated as separate units of accounting for revenue recognition purposes, and if so, how the aggregate contract value should be allocated among the deliverable elements and when to recognize revenue for each element.

We recognize revenue for delivered elements only when the fair values of undelivered elements are known, when the associated earnings process is complete and, to the extent the milestone amount relates to our performance obligation, when our licensee confirms that we have met the requirements under the terms of the agreement, and when payment is reasonably assured. Changes in the allocation of the contract value between various deliverable elements might impact the timing of revenue recognition, but in any event, would not change the total revenue recognized on the contract. For example, nonrefundable upfront product license fees, for product candidates where we are providing continuing services related to product development, are deferred and recognized as revenue over the development period.

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Milestones, in the form of additional license fees, typically represent nonrefundable payments to be received in conjunction with the achievement of a specific event identified in the contract, such as completion of specified clinical development activities and/or regulatory submissions and/or approvals. We believe that a milestone represents the culmination of a distinct earnings process when it is not associated with ongoing research, development or other performance on our part. We recognize such milestones as revenue when they become due and payment is reasonably assured. When a milestone does not represent the culmination of a distinct earnings process, we recognize revenue in a manner similar to that of an upfront product license fee.

Royalty/Earn-Out Revenue. We recognize royalties under the earn-out provision of the Asset Purchase Agreement with DFB BioTech, Inc. (“DFB”). We have the right to receive earn out payments in the future based on sales of certain products. Generally, under this agreement we would receive royalty payments and a report within ninety (90) days from the end of each calendar year after the licensee has sold the royalty-bearing product. Our right to receive earn out payments under our agreement with DFB will expire in 2013. We recognize royalty revenues when we can reliably estimate such amounts and collectibility is reasonably assured.

Consulting and Technical Assistance Services. We recognize revenues from a consulting and technical assistance contracts primarily as a result of our agreements with DFB and Auxilium. Consulting revenues are recognized ratably over the term of the contract. The consulting obligations to DFB generally expire during March 2011.

Inventory and Warranty Provisions. Inventories are stated at the lower of cost or realizable market value. In assessing the ultimate realization of inventories, we are required to make judgments as to future demand requirements and compare that with the current inventory levels. In March 2006 we sold our topical collagenase business to DFB, including certain product inventory. As of a result of this sale our product inventory as of June 30, 2009 and 2008 was zero.

Reimbursable Third Party Development Costs. We accrue expenses to research and development and capitalize certain patent costs for estimated third party development costs that are reimbursable under our agreement with Auxilium. Estimates are based on contractual terms, historical development costs, reviewing third party data and expectations regarding future development for certain products. Further, we monitor the activities and clinical trials of our development partners.

If conditions or other circumstances change, we may take actions to revise our reimbursable third party development cost estimates. These revisions could result in an incremental increase in research and development costs. For example, the Auxilium Agreement provides that Auxilium and BioSpecifics will share equally in third party costs for the development of the lyophilization of the injection formulation and patent expenses.

On July 13, 2009, we received an updated invoice from Auxilium for approximately $37,000 increasing the total amount due that Auxilium believes is owed by us to approximately $2.84 million through June 30, 2009 under this provision. The increase in the second quarter was primarily due to patent and related legal fees. Based upon the updated invoice, we recorded an additional liability of $37,000 for reimbursable third party patent expenditures.

Based on our preliminary review, we believe that only a portion of the amounts invoiced actually relates to the development of the lyophilization of the injection formulation as well as for patent and related legal fees, and therefore, reserve all rights related to this matter, including but not limited to our right to contest the amount charged by Auxilium.

17


Actual results have differed in the past, and may differ in the future, from our estimates and could impact our earnings in any period during which an adjustment is made.

Receivables and Deferred Revenue. Under our agreement with DFB, we agreed to provide certain technical assistance and transitional services in consideration of fees and costs totaling over $1.4 million. At the closing, DFB paid to us a partial payment of $400,000 in respect of the technical assistance to be provided by us. To date, we have received a total of $1,200,000 in payments from DFB. The consulting obligations generally expire during March 2011. As of June 30, 2009 the remaining accounts receivable balance due was $200,000 for future services and was offset by the associated deferred revenues to be recognized in future periods of $200,000.

Royalty Buy-Down. In August 2008, we signed an agreement to significantly improve the deal terms related to our future royalty obligations for Peyronie's disease by buying down our future royalty obligations with a one-time cash payment. We modified our agreement to lower future royalties payable on net sales of injectable collagenase, XIAFLEX, for Peyronie's disease. In addition, we agreed to pay certain development milestones, if achieved.

As of June 30, 2009, we capitalized $1,250,000 which will be amortized over approximately five years beginning on the date of the first commercial sale of XIAFLEX, for Peyronie's disease, which represents the period estimated to be benefited, using the straight-line method. In accordance with SFAS No. 142, Goodwill and Other Intangibles, the Company amortizes intangible assets with finite lives in a manner that reflects the pattern in which the economic benefits of the assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the assets are amortized using the straight-line method.

Stock Based Compensation. Under the provisions of SFAS 123(R), we estimate the fair value of our employee stock awards at the date of grant using the Black-Scholes option-pricing model, which requires the use of certain subjective assumptions. The most significant assumptions are our estimates of the expected volatility of the market price of our stock and the expected term of the award. Expected volatility is based on the historical volatility of our common stock. When establishing an estimate of the expected term of an award, we consider the vesting period for the award, our historical experience of employee stock option exercises (including forfeitures) and the expected volatility. As required under the accounting rules, we review our valuation assumptions at each grant date and, as a result, we are likely to change our valuation assumptions used to value employee stock-based awards granted in future periods.

Further, SFAS 123(R) requires that employee stock-based compensation costs to be recognized over the requisite service period, or the vesting period, in a manner similar to all other forms of compensation paid to employees. The allocation of employee stock-based compensation costs to each operating expense line are estimated based on specific employee headcount information at each grant date and estimated stock option forfeiture rates and revised, if necessary, in future periods if actual employee headcount information or forfeitures differ materially from those estimates. As a result, the amount of employee stock-based compensation costs we recognize in each operating expense category in future periods may differ significantly from what we have recorded in the current period.

RESULTS OF OPERATIONS

THREE-MONTHS ENDED JUNE 30, 2009 and 2008

Revenues

Product Revenues, net

Product revenues include the sales of the API Enzyme recognized at the time it is shipped to customers. We recognized a small amount of revenue from the sale of collagenase for laboratory use. For the three months ended June 30, 2009 and 2008 product revenues were $9,914 and $4,046, respectively. This increase of $5,868 or 145% was primarily related to the amount of material required to perform testing by our customers.

18


Royalties

We received all of our royalty revenues from DFB under the earn out payment provision of the Asset Purchase Agreement after certain net sales levels are achieved. Royalty revenues recognized under our agreement with DFB for the three months ended June 30, 2009 were $375,400 and $2,028 in the 2008 period. This increase is mainly related to the increase in net sales during the period reported to us by DFB.

Licensing and Milestone Revenues

For the three months ended June 30, 2009 and 2008, we recognized licensing and milestone revenue of $766,281 and $266,282, respectively. Licensing revenues recognized are related to the cash payments received under the Auxilium Agreement in prior years and amortized over the expected development period. This increase of $500,000 was related to a milestone received and recognized in the second quarter under our agreement with Auxilium.

Under current accounting guidance, nonrefundable upfront license fees for product candidates where we are providing continuing services related to product development, are deferred and recognized as revenue over the development period. The remaining balance will be recognized over the respective development periods or when we determine that we have no ongoing performance obligations.

Consulting Services

We recognize revenues from consulting and technical assistance contracts primarily as a result of the Asset Purchase Agreement and an Auxilium consulting agreement signed in October 2007 which terminated during the second quarter of 2008. Consulting revenues are recognized ratably over the term of the contract. The consulting obligations under the Asset Purchase Agreement generally expire during March 2011. For the three months ended June 30, 2009 and 2008 consulting revenues were $70,000 and $162,000, respectively. This decrease of $92,000 or 57% in was primarily due to the recognition in 2008 of revenues earned in connection with the October 2007 consulting agreement with Auxilium.

Costs and Expenses

Research and Development Activities

Research and development expenses were $124,192 and $94,432 respectively, for the three months ended March 31, 2009 and 2008. This increase of $29,760 or 32% in research and development expenses was primarily due to certain employee costs which were reimbursable under our agreement with DFB which expired in October 2008 partially offset by decreases in external study development costs.

General and Administrative Expenses

General and administrative expenses were $1,140,485 and $1,173,316 for the three months ended June 30, 2009 and 2008, respectively. The decrease in general and administrative expenses of $32,831 or 3% was primarily due to lower stock-based compensation expense and legal fees partially offset by increases in outside consulting expense and certain facility costs which were reimbursable under our agreement with DFB which expired in October 2008.

19


Other Income (expense), net

Other income, net, was $1,649 for the three months ended June 30, 2009 as compared to other income, net of $32,055 for the 2008 period. Components of other income, net, consist of investment income, interest expense and other, net. Investment income for the three months ended June 30, 2009 was $1,688 as compared to $27,528 in the comparable period of 2008. This decrease of $25,840 or 94% was primarily due to lower interest rates and invested balances during the 2009 period. Interest expense for the three months ended June 30, 2009 was minimal in both periods. Other expense, net for the three months ended June 30, 2009 was zero as compared to $4,527 in the 2008 period. The decrease in other expense, net was primarily due to the sale of a company owned vehicle in the 2008 period.

Income Taxes

The expense for income taxes for the three months ended June 30, 2009 was $46,376 and zero in the comparable period of 2008. The increase was due to tax allowance reserve in connection with the recognition of a deferred tax asset arising from the exercise and sale of employee stock options during the second quarter of 2009.

SIX-MONTHS ENDED JUNE 30, 2009 and 2008

Revenues

Product Revenues, net

Product revenues include the sales of the API Enzyme recognized at the time it is shipped to customers. We recognized a small amount of revenue from the sale of collagenase for laboratory use. For the six months ended June 30, 2009 and 2008 product revenues were $17,105 and $16,799, respectively. This increase of $306 or 2% was primarily related to the amount of material required to perform testing by our customers.

Royalties

We received all of our royalty revenues from DFB under the earn out payment provision of the Asset Purchase Agreement after certain net sales levels are achieved. Royalty revenues recognized under our agreement with DFB for the six months ended June 30, 2009 were $375,400 and $2,028 in the 2008 period. This increase is mainly related to the increase in net sales during the period reported to us by DFB.

Licensing and Milestone Revenues

For the six months ended June 30, 2009 and 2008, we recognized licensing and milestone revenue of $1,032,562 and $532,563, respectively. Licensing revenues recognized are related to the cash payments received under the Auxilium Agreement in prior years and amortized over the expected development period. This increase of $500,000 was related to a milestone received and recognized in the second quarter under our agreement with Auxilium.

Under current accounting guidance, nonrefundable upfront license fees for product candidates where we are providing continuing services related to product development, are deferred and recognized as revenue over the development period. The remaining balance will be recognized over the respective development periods or when we determine that we have no ongoing performance obligations.

20


Consulting Services

We recognize revenues from consulting and technical assistance contracts primarily as a result of the Asset Purchase Agreement and an Auxilium consulting agreement signed in October 2007 which terminated during the second quarter of 2008. Consulting revenues are recognized ratably over the term of the contract. The consulting obligations under the Asset Purchase Agreement generally expire during March 2011. For the six months ended June 30, 2009 and 2008 consulting revenues were $140,000 and $284,185, respectively. This decrease of $144,185 or 51% in was primarily due to the recognition in 2008 of revenues earned in connection with the October 2007 consulting agreement with Auxilium.

Costs and Expenses

Research and Development Activities

Research and development expenses were $240,063 and $188,703 respectively, for the six months ended March 31, 2009 and 2008. This increase of $51,360 or 27% in research and development expenses was primarily due to certain employee costs which were reimbursable under our agreement with DFB which expired in October 2008 and stock-based compensation expense partially offset by decreases in external study development costs.

General and Administrative Expenses

General and administrative expenses were $2,307,456 and $1,973,772 for the six months ended June 30, 2009 and 2008, respectively. The increase in general and administrative expenses of $333,684 or 17% was primarily due to outside consulting services, stock-based compensation expense, certain facility costs which were reimbursable under our agreement with DFB which expired in October 2008, employee costs and patent related fees partially offset by a decrease in legal fees.

Other Income (expense), net

Other expense, net, was $4,957 for the six months ended June 30, 2009 as compared to other income, net of $61,879 for the 2008 period. Components of other income, net, consist of investment income, interest expense and other, net. Investment income for the six months ended June 30, 2009 was $4,545 as compared to $57,803 in the comparable period of 2008. This decrease of $53,258 was primarily due to lower interest rates and invested balances during the 2009 period. Interest expense for the six months ended June 30, 2009 was minimal in both periods. Other expense, net for the six months ended June 30, 2009 was $9,463 as compared to other income, net of $4,527 in the 2008 period. The change in other income and expense, net was primarily due to a penalty related to our delinquent tax filings from previous periods partially offset by the sale of a company owned vehicle in the 2008 period.

Income Taxes

The expense for income taxes for the six months ended June 30, 2009 was $46,376 and zero in the comparable period of 2008. The increase was due to tax allowance reserve in connection with the recognition of a deferred tax asset arising from the exercise and sale of employee stock options during the second quarter of 2009.

Liquidity and Capital Resources

To date, we have financed our operations primarily through product sales, debt instruments, licensing revenues, royalties under agreements with third parties and sales of our common stock. At June 30, 2009 and December 31, 2008, we had cash and cash equivalents in the aggregate of $9,324,499 and $3,494,150, respectively.

21


Continuing Operations

Net cash provided by operating activities for the six months ended June 30, 2009 was $5,343,468 as compared to net cash used in operating activities in the 2008 period of $1,164,241. In the 2009 period, as compared to the 2008 period, the changes in net cash provided by operating activities was primarily attributable to a the reduction in accounts receivable due to the receipt of a payment for a sublicense fee of $6.4 million and non-cash stock compensation expense partially offset by increased expenses during the period 2009 period.

Net cash provided by investing activities for the six months ended June 30, 2009 was $400,621 as compared to net cash used in investing activities in the 2008 period of $393,000. The change in net cash provided by investing activities for the 2009 period reflect redemption of our investment in marketable securities compared to cashed used in investing activities related to purchases of marketable securities in the 2008 period.

Net cash provided by financing activities for the six months ended June 30, 2009 was $86,260 as compared to the 2008 period of $6,230,062. The change in net cash provided by financing activities for the 2009 consisted of proceeds received from stock option exercises and excess tax benefits related to the sale by employees of certain stock options. Net cash provided by financing activities in the 2008 period consisted of proceeds from the sale of our common stock of $4,882,679, repayment of an outstanding loan from our former Chairman and CEO of $1,116,558 and proceeds received from stock option exercises of $230,825.

Item 3: Quantitative and Qualitative Disclosures About Market Risk.

Not applicable.

Item 4T. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

The Company, under the supervision and with the participation of Thomas L. Wegman, the Company’s President, Principal Executive Officer and Principal Financial Officer, evaluated the effectiveness of its disclosure controls and procedures as of the end of the period covered by this Report. Based on that evaluation, management has concluded that the Company’s disclosure controls and procedures are effective to ensure that information required to be disclosed in reports filed under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to the Company’s management to allow timely decisions regarding required disclosure. Because of the inherent limitations in all control systems, any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Furthermore, our controls and procedures can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the control, and misstatements due to error or fraud may occur and not be detected on a timely basis.

Changes in Internal Controls

There were no changes in our internal controls over financial reporting during the three and six month periods ended June 30, 2009 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

22


PART II: OTHER INFORMATION

Item 1. Legal Proceedings

None.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Submission of Matters to a Vote of Security Holders

Our 2009 Annual Meeting of Stockholders was held on June 17, 2009 at the offices of Bingham McCutchen LLP in New York, New York, in accordance with the Notice of Annual Meeting of Stockholders sent on or about April 30, 2009. The tables below present the voting results of the matters voted upon by our stockholders at the meeting:

Proposal 1: Election of Directors

At the meeting, each of the nominees listed below was elected to our Board of Directors to serve as director until the end of his or her respective term and received the number votes set forth after their respective names below.

Nominee* Number of Shares
  For Withheld
Thomas L. Wegman 5,480,342 158,335
Dr. Paul Gitman 3,955,424 1,683,253
Dr. Matthew Geller 5,463,026 175,651

_____________
* The Board is divided into three classes, each of which serves for a term of three years, with only one class of directors being elected in each year. Each director holds office for the term for which elected and until his or her successor shall be elected and shall qualify and be subject to such director’s earlier death, resignation or removal. The term of office of the first class of directors, presently consisting of Thomas L. Wegman, Dr. Paul A. Gitman and Dr. Matthew Geller, is scheduled to expire at the annual meeting for the year 2012; the term of office of the second class of directors, presently consisting of Henry Morgan and Michael Schamroth is scheduled to expire on the date of the annual meeting for the year 2010; and the third class of directors, consisting of Toby Wegman and Dr. Mark Wegman is scheduled to expire at the 2011 Annual Meeting.

Proposal 2: Approval of Amended and Restated BioSpecifics Technologies Corp. 2001 Stock Option Plan

At the meeting, our stockholders ratified by the vote set forth below the approval of the Amended and Restated BioSpecifics Technologies Corp. 2001 Stock Option Plan to extend the term of the 2001 Plan from April 6, 2011 to April 23, 2019 and to authorize an additional 300,000 shares of our common stock for issuance under the 2001 Plan from 1,750,000 shares reserved for issuance under the Original 2001 Plan to 2,050,000.

Number of Shares
For Against Abstain
4,089,921 287,588 48,755

23



The number of shares of our common stock eligible to vote as of the record date of April 23, 2009 was 6,014,801 shares.

Item 5. Other Information

On June 15, 2009, Hapoalim Securities USA, Inc. initiated analyst coverage on the Company.

On June 17, 2009, as disclosed on our Form 8-K filed with the SEC on June 19, 2009 that upon the recommendation of the Compensation Committee, the Board of Directors of the Company approved an increase in the base salary of the Company’s President, Thomas Wegman, from $250,000 to $300,000 per year, effective June 17, 2009.

On June 29, 2009, the Company announced that it was added to the Russell 3000 and Russell 2000 Indexes effective at the close of the U.S. markets on June 29, 2009. The Russell 3000 Index measures the performance of the largest 3000 U.S. companies representing approximately 98% of the investable U.S. equity market. The Russell 2000 Index measures the performance of the small-cap segment of the U.S. equity universe. The Russell 2000 Index is a subset of the Russell 3000® Index representing approximately 8% of the total market capitalization of that index. It includes approximately 2,000 of the smallest securities based on a combination of their market cap and current index membership.

Item 6. Exhibits

  3.1 Articles of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant's Annual Report on Form 10-KSB for the fiscal years ended December 31, 2005, 2004 and 2003).
  3.2 Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Annual Report on Form 10-KSB for the fiscal years ended December 31, 2005, 2004 and 2003).
  4 Amended and Restated BioSpecifics Technologies Corp. 2001 Stock Option Plan (and incorporated by reference to Appendix D to the Registrant’s Definitive Proxy Statement filed with the SEC on April 30, 2009).
  10 Lease Modification Agreement dated June 22, 2009 and effective June 24, 2009 (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8- K filed with the SEC on June 29, 2009).
  31* Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule13a-14(a)/15d-14(a).
  32* Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of Sarbanes-Oxley Act of 2002.
  99.1* Audit Committee Charter (revised June 17, 2009)
  99.2* Compensation Committee Charter (revised June 17, 2009)
  99.3* Nominating and Corporate Governance Committee Charter (revised June 17, 2009)

_________
* filed herewith

24


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.

BIOSPECIFICS TECHNOLOGIES CORP.                       
(Registrant)

Date: August 12, 2009 /s/ Thomas L. Wegman                                       
  Thomas L. Wegman
  President
  (Principal Executive and Financial Officer)

25


EX-31 2 exh31.htm EXHIBIT 31 BioSpecifics Technologies Corp.: Exhibit 31 - Prepared by TNT FIlings Inc.

Exhibit 31

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO RULES 13a-14(a) AND 15d-14(a) OF
THE SECURITIES EXCHANGE ACT OF 1934

I, Thomas L. Wegman, certify that:

1.

I have reviewed this report on Form 10-Q for the quarterly period ended June 30, 2009 of BioSpecifics Technologies Corp.;

     
2.

Based on my knowledge, the report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

     
3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

     
4.

The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

     
(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

     
(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

     
(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

     
(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

     
5.

The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and to the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

     

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting.

Date: August 12, 2009

/s/ Thomas L. Wegman                                  
Thomas L. Wegman
President, Principal Executive Officer and Principal Financial Officer


EX-32 3 exh32.htm EXHIBIT 32 BioSpecifics Technologies Corp.: Exhibit 32 - Prepared by TNT FIlings Inc.

Exhibit 32

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO RULES 13a-14(b) AND 15d-14(b) OF
THE SECURITIES EXCHANGE ACT OF 1934 AND
18 U.S.C. SECTION 1350

The undersigned, Thomas L. Wegman, the President, Principal Executive Officer and Principal Financial Officer of BioSpecifics Technologies Corp. (the “Company”), DOES HEREBY CERTIFY that:

  1.

The Company’s report on Form 10-Q for the quarterly period ended June 30, 2009 (the “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and

     
  2.

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company.

IN WITNESS WHEREOF, the undersigned has executed this certification this 12th day of August, 2009.

/s/ Thomas L. Wegman                                   
Thomas L. Wegman
President, Principal Executive Officer and Principal Financial Officer

This certification shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange of 1934, or otherwise subject to liability pursuant to that section. Such certification shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except to the extent that the Company specifically incorporates it by reference.

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.


EX-99.1 4 exh991.htm EXHIBIT 99.1 BioSoecifics Technologies Corp.: Exhbit 99.1 - Prepared by TNT Filings Inc.

BIOSPECIFICS TECHNOLOGIES CORP.

AMENDED AND RESTATED
AUDIT COMMITTEE CHARTER

Adopted on December 4, 2006
Revised June 17, 2009

1.

Purpose of the Audit Committee

     
1.1.

The purpose of the Audit Committee (the “Committee”) of BioSpecifics Technologies Corp. (the “Company”) is to represent and assist the board of directors (the “Board”) in overseeing and monitoring (1) the integrity of the financial statements of the Company; (2) the Company’s compliance with legal and regulatory requirements, (3) the qualifications and independence of the Company’s registered public accounting firm (the “Independent Auditors”); (4) the performance of the Company’s Independent Auditors and any internal audit functions and (5) the business practices and ethical standards of the Company.

     
1.2.

The Committee is also responsible for (a) the appointment, compensation, retention and oversight of the work of the Company’s Independent Auditors and (b) the preparation of the report required by the rules of the Securities and Exchange Commission (the “Commission”) to be included in the Company’s annual proxy statement.

     
1.3.

It is not the duty of the Committee to plan or conduct audits or to determine that the Company’s financial statements and disclosures are presented fairly in all material respects in accordance with generally accepted accounting principles. The Audit Committee members are not professional accountants or auditors and their functions are not intended to duplicate or to certify the activities of management and the Independent Auditor.

     
1.4.

The Audit Committee serves a board level oversight role where it oversees the relationship with the Independent Auditor, as set forth in this charter, receives information and provides advice, counsel and general direction, as it deems appropriate, to management and the Independent Auditors, taking into account the information it receives, discussions with the Independent Auditor, and the experience of the Audit Committee's members in business, financial and accounting matters.

     
2.

Committee Membership

     

The Committee shall be comprised of at least three directors determined by the Board. All members of the Committee must each be independent. To be considered independent, each Committee member must meet the independence requirements of the Sarbanes-Oxley Act of 2002 (SOX) and the rules and regulations of the Commission as well as any applicable securities exchange or market requirements. Each member shall be financially literate, as defined by the Commission, or must become financially literate within a reasonable period of time after their appointment to the Committee.




3.

Committee Composition/Compensation

     
3.1.

The members of the Committee shall be nominated and elected by the Board and shall serve until their successors shall be duly elected and qualified. Unless a Chairman is elected by the full Board, the members of the Committee shall designate a Chair by majority vote of all of the Committee members.

     
3.2.

Unless otherwise determined by the Board (in which case disclosure of such determination shall be made in the Company’s annual proxy statement), no member of the Committee may serve on the audit committee of more than two other public companies.

     
3.3.

No member of the Committee may receive, directly or indirectly, any consulting, advisory or other compensatory fee from the Company or any of its subsidiaries, other than fees paid in his or her capacity as a member of the Board or a committee of the Board.

     
4.

Meetings

     
4.1.

The Committee shall meet at least four times annually or more frequently as circumstances dictate or as the Committee or its Chair deem advisable. Attendance by at least two of the three members of the Committee at any meeting shall constitute a quorum and shall be sufficient for the taking of any action before the Committee.

     
4.2.

The Committee shall meet in executive session with the Independent Auditor, the principal financial officer and management at least annually and at the time the Company reviews the financial statements with the Independent Auditor.

     
4.3.

The Committee will cause adequate minutes of all its proceedings to be kept, and will report on its actions and activities at the next quarterly meeting of the Board. Committee members will be furnished with copies of the minutes of each meeting and any action taken by unanimous consent. The Committee is governed by the same rules regarding meetings (including meetings by conference telephone or similar communications equipment), action without meetings, notice, waiver of notice, and quorum and voting requirements as are applicable to the Board.




4.4.

The Committee is authorized to adopt its own rules of procedure not inconsistent with (a) any provision of this Charter, (b) any provision of the Bylaws of the Company, or (c) the laws of the State of Delaware.

     
4.5.

The Chairman of the Committee is to be notified directly by the principal financial officer and the Independent Auditor (1) to review items of a sensitive nature that can impact the accuracy of financial reporting or (2) to discuss significant issues relative to the overall Board responsibility that have been communicated to management but, in their judgment, may warrant follow-up by the Committee.

     
5.

Authority

     
5.1.

The Committee will have the resources and authority necessary to discharge its duties and responsibilities. The Committee shall have the authority to engage independent legal, accounting and other advisers, as it determines necessary to carry out its duties. The Committee shall have sole authority to approve related fees and retention terms. Any communications between the Committee and legal counsel in the course of obtaining legal advice will be considered privileged communications of the Company and the Committee will take all necessary steps to preserve the privileged nature of those communications.

     
5.2.

The Committee may form and delegate authority to subcommittees and may delegate authority to one or more designated members of the Committee.

     
6.

Responsibilities

     

The Audit Committee:

     
6.1.

is directly responsible for the appointment, replacement, compensation, and oversight of the work of the Independent Auditor. The Independent Auditor shall report directly to the Committee.

     
6.2.

obtains and reviews annually a report by the Independent Auditor describing the firm's internal quality-control procedures; any material issues raised by the most recent internal quality-control review or peer review or by any inquiry or investigation by governmental or professional authorities, within the preceding five years, respecting one or more independent audits carried out by the firm, and any steps taken to deal with any such issues.




  6.3.

reviews and discusses with the Independent Auditor the written statement from the Independent Auditor concerning any relationship between the auditor and the Company or any other relationships that may adversely affect the independence of the auditor, and, based on such review, assesses the independence of the auditor.

     
  6.4.

establishes policies and procedures for the review and pre-approval by the Committee of all auditing services and permissible non-audit services (including the fees and terms thereof) to be performed by the Independent Auditor.

     
  6.5.

reviews and discusses with the Independent Auditor: (a) its audit plans, and audit procedures, including the scope, fees and timing of the audit; (b) the results of the annual audit examination and accompanying management letters; and (c) the results of the Independent Auditor's procedures with respect to interim periods.

     
  6.6.

reviews and discusses reports from the Independent Auditors on (a) all critical accounting policies and practices used by the Company, (b) alternative accounting treatments within GAAP related to material items that have been discussed with management, including the ramifications of the use of the alternative treatments and the treatment preferred by the Independent Auditor, and (c) other material written communications between the Independent Auditor and management.

     
  6.7.

reviews and discusses with the Independent Auditor the Independent Auditor's judgments as to the quality, not just the acceptability, of the Company's accounting principles and such further matters as the Independent Auditors present the Committee under generally accepted auditing standards.

     
  6.8.

discusses with management and the Independent Auditor quarterly earnings press releases, including the interim financial information and Business Outlook included therein, reviews the year-end audited financial statements and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and, if deemed appropriate, recommends to the Board that the audited financial statements be included in the Annual Report on Form 10-KSB for the year.

     
  6.9.

reviews and discusses with management and the Independent Auditor various topics and events that may have significant financial impact on the Company or that are the subject of discussions between management and the Independent Auditors.




  6.10.

reviews and discusses with management the Company's major financial risk exposures and the steps management has taken to monitor and control such exposures.

     
  6.11.

reviews and approves or disapproves related-party transactions.

     
  6.12.

reviews and discusses with management, the Independent Auditor, and the Company's principal financial officer: (a) the adequacy and effectiveness of the Company's internal controls (including any significant deficiencies and significant changes in internal controls reported to the Committee by the Independent Auditor or management); (b) the Company's internal audit procedures; and (c) the adequacy and effectiveness of the Company's disclosures controls and procedures, and management reports thereon.

     
  6.13.

reviews annually with the principal financial officer the scope of the internal audit program, and reviews annually the performance of both the internal audit staff and the Independent Auditor in executing their plans and meeting their objectives.

     
  6.14.

reviews matters related to the corporate compliance activities of the Company.

     
  6.15.

establishes procedures for the receipt, retention and treatment of complaints received by the Company regarding accounting, internal accounting controls, or auditing matters, and the confidential, anonymous submission by employees of concerns regarding questionable accounting or auditing matters.

     
  6.16.

establishes policies for the hiring of employees and former employees of the Independent Auditor.

     
  6.17.

publishes the report of the Committee required by the rules of the Commission to be included in the Company's annual proxy statement.

     
  6.18.

when appropriate, designates one or more of its members to perform certain of its duties on its behalf, subject to such reporting to or ratification by the Committee as the Committee shall direct.

     
  6.19.

will engage in an annual self-assessment with the goal of continuing improvement, and will annually review and reassess the adequacy of its charter, and recommends any changes to the full Board.



EX-99.2 5 exh992.htm EXHIBIT 99.2 BioSpecifics Technologies Corp.: Exhibit 99.2 - Prepared by TNT Filings Inc.

BIOSPECIFICS TECHNOLOGIES CORP.

COMPENSATION COMMITTEE CHARTER

Adopted on December 4, 2006
Revised June 17, 2009

A.

Purpose

The purpose of the Compensation Committee of the Board of Directors (the "Board") of BioSpecifics Technologies Corp. (the "Company") is to oversee the discharge of the responsibilities of the Board relating to compensation of the Company's executive officers.

B.

Structure and Membership

1.

Number. The Compensation Committee shall consist of at least two members of the Board, two of whom are independent directors, as defined in any applicable exchange listing requirements, non-employee directors, as defined in SEC Rule 16b-3, and outside directors, as defined in Treasury Regulations 1.162-27.

2.

Chair. Unless the Board elects a Chair of the Compensation Committee, the Compensation Committee shall elect a Chair by majority vote; for the avoidance of doubt, if there are only two members on the Compensation Committee then such Chair of the Compensation Committee, if elected by the members, shall be elected by the affirmative vote of both members.

3.

Compensation. The compensation of Compensation Committee members shall be as determined by the Board.

4.

Selection and Removal. Members of the Compensation Committee shall be appointed by the Board. The Board may remove members of the Compensation Committee from such committee, with or without cause.

C.

Authority and Responsibilities

General

The Compensation Committee shall discharge its responsibilities in compliance with the "Delaware Business Judgment Rule."

Compensation Matters

1.

CEO Compensation. The Compensation Committee shall annually review and approve corporate goals and objectives relevant to the compensation of the Company's Chief Executive Officer (the "CEO"), evaluate the CEO's performance in light of those goals and objectives, and, either as a committee or together with other independent directors (as determined from time to time by the Committee), establish and approve the CEO's compensation.


2.

Compensation of Other Executive Officers. The Compensation Committee, following the guidelines set forth in C.1 above, shall periodically review and approve, or make recommendations to the Board with respect to, compensation of the Company's executive officers (other than the CEO).

3.

Evaluation of Senior Executives. The Compensation Committee shall be responsible for overseeing the evaluation of the Company's senior executives. The Compensation Committee shall determine the nature and frequency of the evaluation and the persons subject to the evaluation, supervise the conduct of the evaluation and prepare assessments of the performance of the Company's senior executives, to be discussed periodically with the Board.

4.

Plan Recommendations and Approvals. The Compensation Committee shall periodically review and make recommendations to the Board with respect to such incentive-compensation and other plans that have been approved by the Board.

5.

Administration of Plans. The Compensation Committee shall exercise all rights, authority and functions of the Board under all of the Company's incentive compensation plans, including both annual plans and long-term plans, and both cash and equity-based plans, including without limitation, the authority to interpret the terms thereof, to grant awards, and to establish and confirm satisfaction of performance goals; provided, however, that, except as otherwise expressly authorized to do so by this charter or a plan or resolution of the Board, the Compensation Committee shall not be authorized to amend any such plan. To the extent permitted by applicable law and the provisions of a given equity-based plan, and consistent with the requirements of applicable law and such equity-based plan, the Compensation Committee may delegate to one or more executive officers of the Company the power to grant options or other stock awards pursuant to such equity-based plan to employees of the Company or any subsidiary of the Company who are not directors or executive officers of the Company.

6.

Additional Powers. The Compensation Committee shall have such other duties and responsibilities as may be delegated from time to time by the Board.

D.

Procedures and Administration

1.

Meetings. The Compensation Committee shall meet as often as it deems necessary in order to perform its responsibilities but in no event less than once a year. The Compensation Committee may also act by unanimous written consent in lieu of a meeting. The Compensation Committee shall keep such records of its meetings as it shall deem appropriate.

2.

Subcommittees. The Compensation Committee may form and delegate authority to one or more subcommittees as it deems appropriate from time to time under the circumstances.

3.

Reports to Board. The Compensation Committee shall report regularly to the Board.

2


4.

Charter. The Compensation Committee shall periodically review and reassess the adequacy of this Charter and recommend any proposed changes to the Directors for approval.

5.

Consulting Arrangements. The Compensation Committee shall have the sole authority to retain and/or terminate any compensation consultant used to assist in the evaluation of executive officer compensation and shall have sole authority to approve the consultant's fees and other retention terms. The Compensation Committee shall also have authority to commission compensation surveys or studies as the need arises. The Compensation Committee is empowered, without further action by the Board, to cause the Company to pay the compensation of such consultants as established by the Compensation Committee.

6.

Independent Advisors. The Compensation Committee is authorized, without further action by the Board, to engage such independent legal, accounting or other advisors as it deems necessary or appropriate to carry out its responsibilities. Such independent advisors may be regular advisors to the Company. The Compensation Committee is empowered, without further action by the Board, to cause the Company to pay the compensation of such advisors as established by the Compensation Committee.

7.

Investigations. The Compensation Committee shall have the authority to conduct and/or authorize investigations into any matters within the scope of its responsibilities as it shall deem appropriate. The Committee shall have the authority to request any officer, employee or advisor of the Company to meet with it or any advisors engaged by the Compensation Committee.

8.

Annual Self-Evaluation. At least annually, the Compensation Committee shall evaluate its own performance.

3


EX-99.3 6 exh993.htm EXHIBIT 99.3 BioSpecifics Technologies Corp.: Exhibit 99.3 - Prepared by TNT Filings Inc.

BIOSPECIFICS TECHNOLOGIES CORP.

NOMINATING AND CORPORATE GOVERNANCE COMMITTEE CHARTER

ADOPTED APRIL 7, 2008
REVISED JUNE 17, 2009

Purposes of Committee

The purposes of the Nominating and Corporate Governance Committee (the “Committee”) of the Board of Directors (the “Board”) of BioSpecifics Technologies Corp. (the “Company”) are: (1) to identify individuals qualified to become Board members, and to recommend to the Board, the nominees for Director at the next Annual Meeting of stockholders; (2) to recommend to the Board nominees for each committee of the Board; (3) to develop and recommend to the Board corporate governance principles applicable to the Company; and (4) to lead the Board in its annual review of the Board’s performance.

Committee Membership

The Committee shall have two or more members, each of whom satisfies the requirements for independence under applicable law and in accordance with the Marketplace Rules of NASDAQ. Committee members shall serve at the pleasure of the Board and for such term or terms as the Board may determine.

Committee Structure and Operations

The Board shall designate one member of the Committee as its Chair. The Committee shall meet at a time and place determined by the Board or the Committee Chair. Additional meetings shall be held when deemed necessary or desirable by a majority of the Committee or its Chair. The Committee will meet periodically in executive session without management present.

A majority of the Committee members currently holding office constitutes a quorum for the transaction of business. The Committee may take action only upon the affirmative vote of a majority of the Committee members present at a duly held meeting. The Committee may meet in person or telephonically and may act by unanimous written consent. The Committee may invite such members of management to its meetings as it may deem desirable or appropriate.

Committee Duties

The duties of the Committee are to:

1.

Receive from stockholders and others recommendations for nominees for election to the Board, and recommend to the Board candidates for Board membership for consideration by the stockholders at the Annual Meeting of Stockholders and candidates for election to the board at intervals between Annual Meetings. In recommending candidates to the Board, the Committee shall take into consideration the Board’s criteria for selecting new directors, including but not limited to integrity, past achievements, judgment, intelligence, relevant experience and the ability of the candidate to devote adequate time to Board duties.




2.

Recommend to the Board the committee structure of the Board and the composition and membership of such committees and the designation of the Chairman of each such committee.

   
3.

Review and make recommendations to the Board concerning the composition, organization and processes of the Board, including the function, size and membership, including qualification therefor, of Board committees; and policies relating to director tenure and retirement.

   
4.

Develop and recommend to the Board procedures for the performance evaluation of the Board and its committees.

   
5.

Review the corporate governance principles of the Company and recommend to the Board any proposed changes it may deem appropriate.

   
6.

Review and assess the adequacy of this Charter, and recommend any amendments it deems appropriate.

   
7.

Perform such other activities consistent with this Charter as the Committee deems necessary or appropriate.

Committee Reports

The Committee shall:

1.

Report to the Board on a regular basis on the activities of the Committee and make such recommendations with respect to the above matters as the Committee may deem necessary or appropriate.

   
2.

Annually assess the performance of the Committee with respect to the duties and responsibilities of the Committee as set forth in this Charter.

Resources and Authority of the Committee

The Committee shall have the resources and funding necessary or appropriate for the Committee to discharge its duties and responsibilities as set forth in this Charter and as required by law or regulation. The Committee shall have the authority to retain and terminate any search firm to be used to identify director candidates and shall have the authority to approve the search firm’s fees and other retention terms. The Committee shall also have the authority to retain, discharge and approve fees and other terms for advice and assistance from legal counsel and other independent experts or advisors. The Committee may request any officer, director or employee of the Company or the Company’s outside search firm, consultants or advisors to attend a Committee meeting or meet with any Committee members.

2


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