0001140361-12-035961.txt : 20120809 0001140361-12-035961.hdr.sgml : 20120809 20120809114428 ACCESSION NUMBER: 0001140361-12-035961 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 9 CONFORMED PERIOD OF REPORT: 20120630 FILED AS OF DATE: 20120809 DATE AS OF CHANGE: 20120809 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: 121019227 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 form10q.htm BIOSPECIFICS TECHNOLOGIES CORP 10Q 6-30-2012 form10q.htm


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, 2012

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

001-34236
(Commission file number)

BIOSPECIFICS TECHNOLOGIES CORP.
(Exact Name of Registrant as Specified in Its Charter)
 
Delaware
 
11-3054851
(State or Other Jurisdiction of Incorporation or Organization)
 
(I.R.S. Employer 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                   x
Non-accelerated filer    (Do not check if a smaller reporting company)
Smaller reporting company o

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 6, 2012
Common Stock ($.001 par value)
 
6,332,452



 
 

 
 
BIOSPECIFICS TECHNOLOGIES CORP.

TABLE OF CONTENTS
 
 
PART II – OTHER INFORMATION
 
ITEM 1.
25
ITEM 1A.
25
ITEM 2.
25
ITEM 3.
26
ITEM 4.
26
ITEM 5.
26
ITEM 6.
26


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 Corp. (“ABC-NY”).

Introductory Comments – Forward-Looking Statements

This Report includes “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are “forward-looking statements.” The forward-looking statements include statements concerning, among other things, the timing of submission of a sBLA filing to the FDA for XIAFLEX as a treatment for Peyronie’s disease and subsequent launch in that indication; the potential market for XIAFLEX in human lipoma and canine lipoma; the timing for completing clinical trials for the use of XIAFLEX in the treatment of human lipoma, canine lipoma, cellulite, and frozen shoulder; the potential for Auxilium to receive approval to expand the label for Dupuytren’s contracture; and the timing of making XIAFLEX available in Canada. In some cases, these statements can be identified by forward-looking words such as “believe,” “expect,” “anticipate,” “plan,” “estimate,” “likely,” “may,” “will,” “could,” “continue,” “project,” “predict,” “goal,” the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on BioSpecifics’ current expectations and its projections about future events. There are a number of important factors that could cause BioSpecifics’ actual results to differ materially from those indicated by such forward-looking statements, including the ability of BioSpecifics’ partner, Auxilium, and its partners, Pfizer Inc., Asahi Kasei Pharma Corporation and Actelion Pharmaceuticals Canada Inc., to achieve their objectives for XIAFLEX in their applicable territories; the potential market for XIAFLEX in a given indication, the potential of XIAFLEX to be used in additional indications, and the initiation, timing and outcome of clinical trials of XIAFLEX for additional indications; the timing of regulatory filings and action; the receipt of any applicable milestone payments from Auxilium; and other risk factors identified in BioSpecifics’ Annual Report on Form 10-K for the year ended December 31, 2011, its Quarterly Reports on Form 10-Q for the first quarter of 2012, and its Current Reports on Form 8-K filed with the Securities and Exchange Commission. All forward-looking statements included in this Report are made as of the date hereof, and BioSpecifics assumes no obligation to update these forward-looking statements.
 
 
PART I – FINANCIAL INFORMATION

Item 1:
Consolidated Financial Statements

BioSpecifics Technologies Corp.
Consolidated Balance Sheets

   
June 30,
 2012
   
December 31,2011
 
   
(unaudited)
   
(audited)
 
Assets
           
Current assets:
           
Cash and cash equivalents
  $ 3,788,173     $ 3,196,831  
Short-term investments
    5,000,000       5,000,000  
Accounts receivable, net
    2,820,845       3,236,917  
Income tax receivable
    51,070       244,720  
Deferred tax assets
    826,534       1,309,801  
Prepaid expenses and other current assets
    219,481       98,234  
Total current assets
    12,706,103       13,086,503  
                 
Deferred royalty buy-down
    2,750,000       1,250,000  
Deferred tax assets - long term
    1,805,366       1,738,154  
Patent costs, net
    225,193       190,416  
                 
Total assets
    17,486,662       16,265,073  
                 
Liabilities and Stockholders' Equity
               
Current liabilities:
               
Accounts payable and accrued expenses
    659,764       601,002  
Accrued tax liability
    102,471       -  
Deferred revenue
    253,115       437,099  
Accrued liabilities of discontinued operations
    78,138       78,138  
Total current liabilities
    1,093,488       1,116,239  
                 
Long-term deferred revenue
    241,955       276,520  
                 
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 ; 6,554,743 and 6,530,743 shares issued at June 30, 2012 and December 31, 2011, respectively
    6,555        6,531  
Additional paid-in capital
    20,404,909       20,049,196  
Accumulated deficit
    (1,882,832 )     (3,291,904 )
Treasury stock, 223,191 and 194,604 shares at cost at June 30, 2012  and December 31, 2011, respectively
    (2,377,413 )     (1,891,509 )
Total stockholders' equity
    16,151,219       14,872,314  
                 
Total liabilities and stockholders’ equity
  $ 17,486,662     $ 16,265,073  

See accompanying notes to consolidated financial statements
 
 
BioSpecifics Technologies Corp.
Consolidated Statements of Operations
(unaudited)
 
   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2012
   
2011
   
2012
   
2011
 
Revenues:
                       
Net sales
  $ 1,246     $ 5,882     $ 8,750     $ 11,774  
Royalties
    2,491,313       1,706,166       4,391,282       2,651,247  
Licensing revenues
    109,275       3,296,776       788,550       4,156,051  
Consulting fees
    -       -       -       46,667  
Total Revenues
    2,601,834       5,008,824       5,188,582       6,865,739  
                                 
Costs and expenses:
                               
Research and development
    404,346       270,799       653,898       482,865  
General and administrative
    1,149,926       1,418,016       2,238,648       2,927,542  
Total Cost and Expenses
    1,554,272       1,688,815       2,892,546       3,410,407  
                                 
Operating income
    1,047,562       3,320,009       2,296,036       3,455,332  
                                 
Other income (expense):
                               
Interest income
    9,771       16,688       19,264       33,248  
Other income (expense)
    -       14,479       -       14,479  
      9,771       31,167       19,264       47,727  
                                 
Income before expense for income tax
    1,057,333       3,351,176       2,315,300       3,503,059  
Income tax benefit (expense)
    (390,651 )     (781,835 )     (906,228 )     2,757,405  
                                 
Net income
  $ 666,682     $ 2,569,341     $ 1,409,072     $ 6,260,464  
                                 
Basic net income per share
  $ 0.11     $ 0.40     $ 0.22     $ 0.99  
Diluted net income per share
  $ 0.10     $ 0.36     $ 0.20     $ 0.87  
                                 
Shares used in computation of basic net income per share
   
6,343,356
     
6,354,135
     
6,339,930
     
6,324,168
 
Shares used in computation of diluted net income per share
   
6,971,687
     
7,174,568
     
6,984,258
     
7,158,024
 
 
Consolidated Statements of Comprehensive Income

(unaudited)

   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2012
   
2011
   
2012
   
2011
 
Net income
  $ 666,682     $ 2,569,341     $ 1,409,072     $ 6,260,464  
Other comprehensive income (loss)
    -       -       -       -  
Comprehensive income
  $ 666,682     $ 2,569,341     $ 1,409,072     $ 6,260,464  
 
See accompanying notes to consolidated financial statements
 

BioSpecifics Technologies Corp.
Consolidated Statements of Cash Flows
(unaudited)

   
Six Months Ended
June 30,
 
Cash flows from operating activities:
 
2012
   
2011
 
Net income
  $ 1,409,072     $ 6,260,464  
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
               
Depreciation and amortization
    29,019       21,220  
Stock-based compensation expense
    175,685       264,907  
Deferred tax assets
    416,055       (3,103,944 )
Changes in operating assets and liabilities:
               
Accounts receivable
    416,072       1,108,734  
Prepaid expenses and other current assets
    72,403       (59,477 )
Accounts payable and accrued expenses
    97,438       (1,889,632 )
Deferred revenue
    (218,550 )     (265,219 )
Net cash provided by operating activities
    2,397,194       2,337,053  
                 
Cash flows from investing activities:
               
Maturity of marketable investments
    2,000,000       -  
Purchases of marketable investments
    (2,000,000 )     -  
Payment for royalty buy down
    (1,500,000 )     -  
Net cash used in investing activities
    (1,500,000 )     -  
                 
Cash flows from financing activities:
               
Proceeds from stock option exercises
    78,000       72,450  
Payments for repurchase of common stock
    (485,904 )     (206,347 )
Excess tax benefits from share-based payment arrangements
    102,052       346,539  
Net cash provided by (used in) in financing activities
    (305,852 )     212,642  
                 
Increase in cash and cash equivalents
    591,342       2,549,695  
Cash and cash equivalents at beginning of year
    3,196,831       2,470,852  
Cash and cash equivalents at end of period
  $ 3,788,173     $ 5,020,547  
                 
Supplemental disclosures of cash flow information:
               
Cash paid during the year for:
               
Interest
    -       -  
Taxes
  $ 92,000       -  

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. For the six month period ended June 30, 2012, we accrued approximately $64,000 related to certain patent costs of which we amortized approximately $29,000 in the 2012 period. For the six months ended June 30, 2011, we accrued approximately $14,000 related to these costs of which approximately $21,000 was amortized in the 2011 period.

See accompanying notes to consolidated financial statements
 

BIOSPECIFICS TECHNOLOGIES CORP.
 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2012
(Unaudited)

1.
ORGANIZATION AND DESCRIPTION OF BUSINESS

We are a biopharmaceutical company involved in the development of an injectable collagenase for multiple indications. We are a party to a development and license agreement with Auxilium Pharmaceuticals, Inc. (“Auxilium”) for injectable collagenase (which Auxilium has named XIAFLEX® (collagenase clostridium histolyticum)) for clinical indications in Dupuytren’s contracture, Peyronie’s disease and frozen shoulder (adhesive capsulitis). Auxilium has an option to acquire additional indications that we may pursue, including cellulite, for which we have granted Auxilium the right to initiate early development studies at its cost, and human and canine lipoma. Auxilium is currently selling XIAFLEX in the U.S. for the treatment of Dupuytren’s contracture. Auxilium has an agreement with Pfizer, Inc. (“Pfizer”) pursuant to which Pfizer has the right to market XIAFLEX for Dupuytren’s contracture and Peyronie’s disease in Europe and certain Eurasian countries, and will do so under the registered trademark XIAPEX® (collagenase clostridium histolyticum). Pfizer received marketing authorization for Dupuytren’s contracture by the European Commission on February 28, 2011 and began sales in certain countries in the European Union in April 2011. In addition, Auxilium has an agreement with Asahi Kasei Pharma Corporation (“Asahi”) pursuant to which Asahi has the right to commercialize XIAFLEX for the treatment of Duputyren’s contracture and Peyronie’s disease in Japan. Auxilium also has an agreement with Actelion Pharmaceuticals Ltd. (“Actelion”) pursuant to which Actelion has the right to commercialize XIAFLEX for the treatment of Duputyren’s contracture and Peyronie’s disease in Canada, Australia, Brazil and Mexico. Actelion was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada.

Pursuant to a March 2006 agreement (the “DFB Agreement”) between the Company and DFB Biotech, Inc. (“DFB”), we continue to receive earn-out payments based on the sales of Santyl.  Our right to receive earn-out payments with respect to the marketed topical product sold to DFB expires in June 2013, but earn-out payments for second generation collagenase products, if any, continue indefinitely.

Operational Highlights

On May 7, 2012, we announced the initiation of a placebo controlled randomized Phase II clinical trial, Chien-804, to evaluate the efficacy of XIAFLEX for canines with benign subcutaneous lipomas. The single injection study will evaluate 32 dogs randomized 1:1 XIAFLEX to placebo. Auxilium has the option to license development and marketing rights to this canine lipoma indication. We anticipate that we will complete enrollment by the first half of 2013.

In a May 9, 2012 press release, Auxilium announced that The Journal of Urology had published on its website, Auxilium’s phase IIb clinical trial of XIAFLEX for the potential nonsurgical treatment of Peyronie’s disease.  Top line data from this trial had been previously reported by Auxilium. The study appeared in the June 2012 print version of The Journal of Urology.

On June 4, 2012, we announced positive top-line results from the IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) Phase III clinical program of XIAFLEX for the treatment of Peyronie's disease, which was conducted by our partner Auxilium. Results from the two randomized, double-blind, placebo-controlled studies at 52 weeks demonstrated statistically significant improvements in both co-primary endpoints of the trials, including percent improvement from baseline in penile curvature deformity compared to placebo and change from baseline (improvement) in the Peyronie's disease bother domain of Auxilium’s Peyronie's Disease Questionnaire (“PDQ”) compared to placebo. Auxilium expects to submit a supplemental Biologics License Application (“sBLA”) filing to the U.S. Food and Drug Administration (“FDA”) by the end of 2012.

On June 26, 2012, we announced that we initiated a Phase II trial of XIAFLEX for the treatment of human lipoma. Human lipomas are encapsulated deposits of benign fat often detected as bulges under the skin and are diagnosed in 575,000 U.S. patients annually. We anticipate that we will complete enrollment by the first half of 2013.
 

In a July 9, 2012 press release, Auxilium and Actelion announced that Auxilium was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada. Under the terms of the Collaboration Agreement between Actelion and Auxilium, Actelion received exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Pursuant to the Collaboration Agreement, Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion and Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in Canada and, upon approval, in the remainder of these countries. Actelion expects to make XIAFLEX available to patients in Canada in the first half of 2013.
 
In a July 30, 2012 press release, Auxilium announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords.  Auxilium enrolled 60 patients at eight sites throughout the U.S. and Australia.  In the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the Company to seek FDA approval and expansion of the Dupuytren's label.  Based on research by SDI Health, LLC estimating that 35 to 40% of annual Dupuytren's surgeries in the US are performed to treat two or more cords concurrently, Auxilium is conducting these studies to seek a multicord indication for XIAFLEX from the FDA. Auxilium expects topline results in the first half of 2014.
 
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 U.S. generally accepted accounting principles (“U.S. GAAP”) has been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for quarterly reporting.

The information included in this Report should be read in conjunction with our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 and our Annual Report on Form 10-K for the year ended December 31, 2011 filed with the SEC on May 10, 2012 and March 13, 2012, respectively.

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

Critical Accounting Policies, Estimates and Assumptions

The preparation of consolidated financial statements in conformity with U.S. GAAP 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 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. Actual results could differ from those estimates.

Cash, Cash Equivalents and Short-term Investments

Cash, cash equivalents and short-term investments 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 short-term investments by placing its investments with banks it believes are highly creditworthy and with highly rated money market funds, U.S. government securities, or certificates of deposit.
 

Fair Value Measurements

The Fair Value Measurements and Disclosures Topic of the Accounting Standards Codification defines fair value, establishes a framework for measuring fair value in applying generally accepted accounting principles, and expands disclosures about fair value measurements. This Codification topic identifies two kinds of inputs that are used to determine the fair value of assets and liabilities: observable and unobservable. Observable inputs are based on market data or independent sources while unobservable inputs are based on our own market assumptions. Once inputs have been characterized, this Codification topic requires us to prioritize the inputs used to measure fair value into one of three broad levels. Fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values identified by Level 2 inputs utilize observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities. Fair values identified by Level 3 inputs are unobservable data points and are used to measure fair value to the extent that observable inputs are not available. Unobservable inputs reflect our own assumptions about the assumptions that market participants would use in pricing the asset or liability.

The following table presents information about our assets and liabilities that are measured at fair value on a recurring basis for the period presented and indicates the fair value hierarchy of the valuation techniques we utilized to determine such fair value.
 
June 30, 2012
   
Fair Value
     
Quoted Prices in
Active Markets for
Identical Assets
Level 1
     
Significant
Other Observable
Inputs
Level 2
     
Significant
Unobservable
Inputs
Level 3
 
Cash and cash equivalents
  $ 3,788,173     $ 3,788,173       -       -  
Certificates of Deposit
    5,000,000       5,000,000       -       -  

Revenue Recognition

We currently recognize revenues resulting from product sales, the licensing and sublicensing of the use of our technology and from services we sometimes perform in connection with the licensed technology under the guidance of Accounting Standards Codification 605, Revenue Recognition (“ASC 605”).

If we determine that separate elements exist in a revenue arrangement under ASC 605, 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 of lab reagents 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 collagenase for laboratory use that are recognized at the time the product is shipped to customers for laboratory use.

Royalty / Mark-up on Cost of Goods Sold / Earn-Out Revenue

For those arrangements for which royalty, mark-up on cost of goods sold or earn-out payment information becomes available and collectability is reasonably assured, we recognize revenue during the applicable period earned. For interim quarterly reporting purposes, when collectability is reasonably assured but a reasonable estimate of royalty, mark-up on cost of goods sold or earn-out payment revenues cannot be made, the royalty, mark-up on cost of goods sold and earn-out payment revenues are generally recognized in the quarter that the applicable licensee provides the written report and sufficient related information to us.
 

Under our development and license agreement with Auxilium (as amended and restated on each of December 11, 2008 and August 31, 2011, the “Auxilium Agreement”), we do not participate in the selling, marketing or manufacturing of products for which we receive royalties and a mark-up of the cost of goods sold revenues. The royalty and mark-up on cost of goods sold revenues will generally be recognized in the quarter that Auxilium provides the written reports and related information to us, that is, royalty and mark up on cost of goods sold revenues are generally recognized one quarter following the quarter in which sales by Auxilium occurred. The royalties payable by Auxilium to us are subject to set-off for certain patent costs.

Under a March 2006 agreement (the “DFB Agreement”), pursuant to which we sold our topical collagenase business to DFB Biotech, Inc. and its affiliates (“DFB”), we have the right to receive earn-out payments in the future based on sales of certain products.  Generally, under the DFB Agreement we would receive payments and a report within ninety (90) days from the end of each calendar year after DFB has sold the royalty-bearing product. Currently, DFB is providing us earn-out reports on a quarterly basis.

License Revenue

We include revenue recognized from upfront licensing, sublicensing and milestone payments in “License Revenues” 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 U.S. Food and Drug Administration 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 consulting and technical assistance contracts primarily as a result of the DFB Agreement. Consulting revenues are recognized ratably over the term of the contract. The consulting and technical assistance obligations to DFB expired in March 2011.
 
Treasury Stock
 
The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders’ equity.
 

Accounts receivable and Allowance for Doubtful Accounts

Trade accounts receivable are stated at the amount the Company expects to collect. We maintain allowances for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. We consider the following factors when determining the collectability of specific customer accounts: customer credit-worthiness, past transaction history with the customer, current economic industry trends, and changes in customer payment terms.  Our accounts receivable balance is typically due from its two large pharmaceutical customers.  These companies have historically paid timely and have been financially stable organizations.  Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.  If the financial condition of our customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required.  We provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after we have used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable.  We recorded no material bad debt expense in the quarter ended June 30, 2012.  The allowance for doubtful accounts balance as of June 30, 2012 and 2011 was $30,095.
 
Accounts receivable as of June 30, 2012 is approximately $2.8 million, which consists of approximately $1.3 million due from DFB in accordance with the earn-out under the DFB Agreement and approximately $1.5 million in royalties due from Auxilium in accordance with the terms of the Auxilium Agreement.
 
Reimbursable Third Party Development Costs

We accrue expenses for research and development that are reimbursable by us under the Auxilium Agreement.  We capitalize certain patent costs related to estimated third party development costs that are reimbursable under the Auxilium Agreement. In August 2011, through the amendment and restatement of our development and license agreement with Auxilium, we have clarified the rights and responsibilities of the joint development of XIAFLEX. We resolved what had been an on-going dispute with Auxilium concerning the appropriate amount of creditable third party development expenses related to the lyophilization of the injection formulation and certain patent expenses for research and development costs that were reimbursable under the Auxilium Agreement. We do not expect any additional third party development cost related to the lyophilization of the injection formulation.  Any estimates of patent costs are based on contractual terms, historical costs, reviewing third party data and expectations regarding future development for certain products.

If conditions or other circumstances change, we may take actions to revise our reimbursable third party patent cost estimates. These revisions could result in an incremental increase or decrease in research and development costs. For example, the Auxilium Agreement provides that Auxilium and BioSpecifics will share equally certain patent expenses which are creditable against future royalty revenues.

As of June 30, 2012 our net reimbursable third party patent costs accrual was approximately $74,000.

Research and Development Expenses

Research and development (“R&D”) expenses include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expense, facility costs and overhead. R&D expenses also consist of third party costs, such as medical professional fees, product costs used in clinical trials, consulting fees and costs associated with clinical study 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

The Company has two stock-based compensation plans in effect. Accounting Standards Codification 718, Compensation - Stock Compensation (“ASC 718”) requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based awards including stock options and common stock issued to our employees and directors under our stock plans. It requires companies to estimate the fair value of share-based awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service periods in our consolidated statements of operations.

Under the ASC 718, 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 an 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 the expected term of an award, we use the simplified method. 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 Company granted 15,000 stock options, valued at approximately $109,000, during the three month period ended June 30, 2012. The Company used Black-Scholes valuation model to estimate the value of options using 54% volatility, a risk free rate of 0.69% and average exercise period of five years.
 
Further, ASC 718 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 ASC 718 was as follows:

   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2012
   
2011
   
2012
   
2011
 
Research and development
  $ 122,679     $ 25,457     $ 144,817     $ 52,573  
General and administrative
    13,200       105,752       30,868       212,334  
Total stock-based compensation expense
  $ 135,879     $ 131,209     $ 175,685     $ 264,907  
 

Stock Option Activity

A summary of our stock option activity during the six months ended June 30, 2012 is presented below:

Options
 
Total Number
of Shares
   
Weighted-Average
Exercise Price
 
Outstanding as of December 31, 2011
    1,261,425     $ 8.27  
Granted
    15,000       15.75  
Forfeited
    -       -  
Exercised
    24,000       3.25  
Expired
    -       -  
Outstanding as of June 30, 2012
    1,252,425     $ 8.46  
                 
Exercisable as of June 30, 2012
    1,172,425     $ 7.48  

During the six months ended June 30, 2012 and 2011, $78,000 and $72,450, respectively, were received from stock options exercised by option holders.

The aggregate intrinsic value of options outstanding and exercisable as of June 30, 2012 was approximately $13.2 million. Aggregate intrinsic value represents the total pre-tax intrinsic value, based on the closing price of our common stock of $18.78 on June 29, 2012, 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, 2012 was approximately $79,000 which we expect to recognize over a weighted-average period of nine months.

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 amortized over the lesser of their estimated useful lives or the remaining life of the lease.

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 use the asset and liability method of accounting for income taxes, as set forth in Accounting Standards Codification 740-10-25-2. Under this method, deferred income taxes, when required, are provided on the basis of the difference between the financial reporting and income tax basis of assets and liabilities at the statutory rates enacted for future periods. In accordance with Accounting Standards Codification 740-10-45-25, Income Statement Classification of Interest and Penalties, we classify interest associated with income taxes under interest expense and tax penalties under other.

Future Impact of Recently Issued Accounting Standards
 
In May 2011, the Financial Accounting Standards Board ("FASB") issued ASU 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and International Financial Reporting Standard ("IFRS"), to converge fair value measurement and disclosure guidance in U.S. GAAP with the guidance in the International Accounting Standards Board's concurrently issued IFRS 13, Fair Value Measurement. The amendments in ASU 2011-04 do not modify the requirements for when fair value measurements apply; rather, they generally represent clarifications on how to measure and disclose fair value under ASC 820, Fair Value Measurement. The amendments in the ASU 2011-04 are effective prospectively for interim and annual periods beginning after December 15, 2011. Early adoption is not permitted for public entities. Adoption of this standard did not have a material impact on the financial statements.
 
In June 2011, the FASB issued Accounting Standards Update No. 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income (“ASU 2011-05”) Under ASU 2011-05, an entity is required to present comprehensive income on the income statement or as a separate financial statement. ASU 2011-05 is effective January 1, 2012. ASU 2011-05 affects financial statement presentation only and has no effect on results of operations or financial position. We adopted this new guidance effective March 31, 2012 and chose to use the two separate but consecutive statements presentation approach.
 
 
3.
NET INCOME (LOSS) PER SHARE

In accordance with Accounting Standards Codification 260, Earnings Per Share, basic net income (loss) per share amount is computed using the weighted-average number of shares of common stock outstanding during the periods presented, while diluted net income (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.

The following table summarizes the number of common equivalent shares that were included for the calculation of diluted net income purposes from continuing operations reported in the consolidated statement of operations.

   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2012
   
2011
   
2012
   
2011
 
Stock options
    628,331       820,433       644,328       833,856  

4.
COMPREHENSIVE INCOME (LOSS)

For the three and six months ended June 30, 2012 and 2011, we had no components of other comprehensive income or loss other than net income itself.
 
5.
ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consisted of the following:
 
     
June 30,
2012
   
December 31,
2011
 
      448,362     407,954  
Accrued legal and other professional fees
    64,379     50,000  
Accrued payroll and related costs
    147,023     143,048  
               
Total
  $ 659,764     $ 601,002  

6.
PATENT COSTS

We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, ranging from 1 to 8 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, 2012, the Company capitalized certain patent costs, paid by Auxilium on behalf of the Company. These costs are reimbursable to Auxilium under the Auxilium Agreement and are creditable against future royalty revenues. Our net patent costs consisted of:

 
 
June 30,
2012
   
December 31,
2011
 
Patents
  $ 382,076     $ 318,280  
Accumulated Amortization
    (156,883 )     (127,863 )
    $ 225,193     $ 190,417  

The amortization expense for patents for six months ended June 30, 2012 was approximately $29,000. In the comparable period of 2011, the amortization expense for patents was approximately $21,000. The estimated aggregate amortization expense for each of the next five years is approximately as follows:

2013
 
52,000
2014
 
42,000
2015
 
17,000
2016
 
14,000
2017 through 2020
 
14,000


7.
INCOME TAXES

The significant components of the Company's deferred tax assets, pursuant to Accounting Standards Codification 740-10-50 consist of net operating losses, orphan tax credits, stock-based compensation and deferred revenues. For the six month period ended June 30, 2012 net income tax expense was $0.9 million, primarily a non-cash charge.  For the six month period ended June 30, 2012, the valuation allowance with respect to the company’s net deferred tax assets remained unchanged.  Our remaining deferred tax assets decreased by $0.4 million to approximately $2.6 million, primarily because we used our Orphan Drug Tax Credit to reduce our taxes payable, during six months ended June 30, 2012.

For the six month period ended June 30, 2011, the valuation allowance reversed by approximately $4.2 million with respect to our net deferred tax assets. We determined that it was more likely than not that these deferred tax assets would be realized based on our projected annual profitability of operations driven by our revenues under the Auxilium Agreement. The remaining balance of deferred tax assets as of June 30, 2011 was approximately $3.1 million.

8.
RELATED PARTY TRANSACTIONS

Our subsidiary, ABC-NY (together with the Company, the “Tenant”) and Wilbur St. Corp. (the “Landlord”) were parties to a lease agreement initially dated as of January 30, 1998 and modified as of June 24, 2009 (the “Lease Agreement”), pursuant to which the Landlord leased to the Tenant the premises located at 35 Wilbur Street, Lynbrook, NY 11563 (the “Premises”) until June 30, 2010 and for a monthly rental price of $11,250 plus utilities and real estate taxes.  Following the expiration of the Lease Agreement, the Tenant has continued to lease the Premises from the Landlord on a month-to-month basis.  We notified the Landlord of our termination of the Lease Agreement effective March 31, 2011, but continue to hold over in the Premises. We are currently evaluating our options with respect to remaining in or leaving the Premises.  Until that evaluation is complete, we will continue to hold over in the Premises on a month-to-month basis.

9.
SUBSEQUENT EVENTS
 
In a July 9, 2012 press release, Auxilium and Actelion announced that Auxilium was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada. Under the terms of the Collaboration Agreement between Actelion and Auxilium, Actelion received exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Pursuant to the Collaboration Agreement, Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion and Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in Canada and, upon approval, in the remainder of these countries. Actelion expects to make XIAFLEX available to patients in Canada in the first half of 2013.
 
In a July 30, 2012 press release, Auxilium announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords.  Auxilium enrolled 60 patients at eight sites throughout the U.S. and Australia.  In the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the Company to seek FDA approval and expansion of the Dupuytren's label.  Based on research by SDI Health, LLC estimating that 35 to 40% of annual Dupuytren's surgeries in the U.S. are performed to treat two or more cords concurrently, Auxilium is conducting these studies to seek a multicord indication for XIAFLEX from the FDA. Auxilium expects topline results in the first half of 2014.
 
We have evaluated subsequent events for recognition or disclosure through the time of filing these consolidated financial statements on Form 10-Q with the U.S. Securities and Exchange Commission on August 9, 2012.
 

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 the related notes thereto included elsewhere in this Report, and is qualified by reference to them.

Overview

We are a biopharmaceutical company involved in the development of an injectable collagenase for multiple indications. We are a party to the Auxilium Agreement, our development and license agreement with Auxilium for injectable collagenase (which Auxilium has named XIAFLEX® (collagenase clostridium histolyticum)) for clinical indications in Dupuytren’s contracture, Peyronie’s disease and frozen shoulder (adhesive capsulitis). Auxilium has an option to acquire additional indications that we may pursue, including cellulite, for which we have granted Auxilium the right to initiate early development studies at its cost, and human and canine lipoma. Auxilium is currently selling XIAFLEX in the U.S. for the treatment of Dupuytren’s contracture. Auxilium has an agreement with Pfizer pursuant to which Pfizer has the right to market XIAFLEX for Dupuytren’s contracture and Peyronie’s disease in Europe and certain Eurasian countries, and will do so under the registered trademark XIAPEX® (collagenase clostridium histolyticum). Pfizer received marketing authorization for Dupuytren’s contracture by the European Commission on February 28, 2011 and began sales in certain countries in the European Union in April 2011. In addition, Auxilium has an agreement with Asahi pursuant to which Asahi has the right to commercialize XIAFLEX for the treatment of Duputyren’s contracture and Peyronie’s disease in Japan. Auxilium also has an agreement with Actelion pursuant to which Actelion has the right to commercialize XIAFLEX for the treatment of Duputyren’s contracture and Peyronie’s disease in Canada, Australia, Brazil and Mexico. Actelion was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada.

Pursuant to the DFB Agreement, we continue to receive earn-out payments based on the sales of Santyl.  Our right to receive earn-out payments with respect to the marketed topical product sold to DFB expires in June 2013, but earn-out payments for second generation collagenase products, if any, continue indefinitely.

Operational Highlights

On May 7, 2012, we announced the initiation of a placebo controlled randomized Phase II clinical trial, Chien-804, to evaluate the efficacy of XIAFLEX for canines with benign subcutaneous lipomas. The single injection study will evaluate 32 dogs randomized 1:1 XIAFLEX to placebo. Auxilium has the option to license development and marketing rights to this canine lipoma indication. We anticipate that we will complete enrollment by the first half of 2013.

In a May 9, 2012 press release, Auxilium announced that The Journal of Urology had published on its website, Auxilium’s phase IIb clinical trial of XIAFLEX for the potential nonsurgical treatment of Peyronie’s disease.  Top line data from this trial had been previously reported by Auxilium. The study appeared in the June 2012 print version of The Journal of Urology.

On June 4, 2012, we announced positive top-line results from the IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) Phase III clinical program of XIAFLEX for the treatment of Peyronie's disease, which was conducted by our partner Auxilium. Results from the two randomized, double-blind, placebo-controlled studies at 52 weeks demonstrated statistically significant improvements in both co-primary endpoints of the trials, including percent improvement from baseline in penile curvature deformity compared to placebo and change from baseline (improvement) in the Peyronie's disease bother domain of Auxilium’s Peyronie's Disease Questionnaire (“PDQ”) compared to placebo. Auxilium expects to submit a supplemental Biologics License Application (“sBLA”) filing to the U.S. Food and Drug Administration (“FDA”) by the end of 2012.

On June 26, 2012, we announced that we initiated a Phase II trial of XIAFLEX for the treatment of human lipoma. Human lipomas are encapsulated deposits of benign fat often detected as bulges under the skin and are diagnosed in 575,000 U.S. patients annually. We anticipate that we will complete enrollment by the first half of 2013.

In a July 9, 2012 press release, Auxilium and Actelion announced that Auxilium was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada. Under the terms of the Collaboration Agreement between Actelion and Auxilium, Actelion received exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Pursuant to the Collaboration Agreement, Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion and Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in Canada and, upon approval, in the remainder of these countries. Actelion expects to make XIAFLEX available to patients in Canada in the first half of 2013.
 
 
In a July 30, 2012 press release, Auxilium announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords.  Auxilium enrolled 60 patients at eight sites throughout the U.S. and Australia.  In the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the Company to seek FDA approval and expansion of the Dupuytren's label.  Based on research by SDI Health, LLC estimating that 35 to 40% of annual Dupuytren's surgeries in the US are performed to treat two or more cords concurrently, Auxilium is conducting these studies to seek a multicord indication for XIAFLEX from the FDA.
 
Outlook

Currently, we generate revenue from two primary sources: in connection with the DFB Agreement and in connection with the Auxilium Agreement.  Under the DFB Agreement, our right to receive earn-out payments with respect to the marketed topical product sold to DFB expires in June 2013, but earn-out payments for second generation collagenase products, if any, continue indefinitely. Under the Auxilium Agreement, we receive sublicense income, royalties, milestones and mark-up on cost of goods sold payments related to the sale and approval of XIAFLEX/XIAPEX as described above.

Significant Risks

We are dependent to a significant extent on third parties, and our principal licensee, Auxilium, may not be able to continue successfully commercializing XIAFLEX for Dupuytren’s contracture, successfully develop XIAFLEX for additional indications, obtain required regulatory approvals, manufacture XIAFLEX 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.

Critical Accounting Policies, Estimates and Assumptions

The preparation of unaudited consolidated financial statements in conformity with U.S. GAAP 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, 2012 and for the three and six months ended June 30, 2012 and 2011 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, 2011 balance sheet amounts and disclosures included herein have been derived from the Company’s December 31, 2011 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 unaudited consolidated financial statements for the period ended March 31, 2012 included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 10, 2012 and the audited consolidated financial statements for year ended December 31, 2011 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2012. 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. 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.

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, 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 for which we are providing continuing services related to product development, are deferred and recognized as revenue over the development period.

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 a 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/ Mark-up on Cost of Goods Sold / Earn-Out Revenue

For those arrangements for which royalty, mark-up on cost of goods sold or earn-out payment information becomes available and collectability is reasonably assured, we recognize revenue during the applicable period earned. For interim quarterly reporting purposes, when collectability is reasonably assured but a reasonable estimate of royalty, mark-up on cost of goods sold or earn-out payment revenues cannot be made, the royalty, mark-up on cost of goods sold or earn-out payment revenues are generally recognized in the quarter that the applicable licensee provides the written report and related information to us.

Under the Auxilium Agreement, we do not participate in the selling, marketing or manufacturing of products for which we receive royalties and a mark-up of the cost of goods sold revenues. The royalty and mark-up on cost of goods sold revenues will generally be recognized in the quarter that Auxilium provides the written reports and related information to us, that is, royalty and mark-up on cost of goods sold revenues are generally recognized one quarter following the quarter in which the underlying sales by Auxilium occurred. The royalties payable by Auxilium to us are subject to set-off for certain patent costs.

Under the DFB Agreement, pursuant to which we sold our topical collagenase business to DFB, we have the right to receive earn-out payments in the future based on sales of certain products.  Generally, under the DFB Agreement we would receive payments and a report within ninety (90) days from the end of each calendar year after DFB has sold the royalty-bearing product. Currently, DFB is providing us earn-out reports on a quarterly basis.

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

Reimbursable Third Party Development Costs. We accrued patent expenses for research and development that are reimbursable by us under the Auxilium Agreement.  We capitalize certain patent costs related to estimated third party development costs that are reimbursable under the Auxilium Agreement. In August 2011, through the amendment and restatement of our development and license agreement with Auxilium, we have clarified the rights and responsibilities of the joint development of XIAFLEX. We resolved what had been an on-going dispute with Auxilium concerning the appropriate amount of creditable third party development expenses related to the lyophilization of the injection formulation and certain patent expenses for research and development costs that are reimbursable under the Auxilium Agreement. We agreed and have reimbursed Auxilium by offsetting future royalties payable for the amount invoiced us for third party development costs related to the development of the lyophilization of the injection formulation. We do not expect any additional third party development cost related to the lyophilization of the injection formulation.

As of June 30, 2012 our net reimbursable third party patent costs accrual was approximately $74,000.
 

Receivables and Deferred Revenue. Accounts receivable as of June 30, 2012 is approximately $2.8 million, which consists of approximately $1.3 million due from DFB in accordance with the earn-out under the DFB Agreement and approximately $1.5 million in royalties due from Auxilium in accordance with the terms of the Auxilium Agreement. Deferred revenue of $0.5 million consist of  licensing fees related to the cash payments received under the Auxilium Agreement in prior years and amortized over the expected development period of certain indications for XIAFLEX.
 
Royalty Buy-Down. On March 31, 2012, we entered into an amendment to our existing agreement, dated August 27, 2008, related to our future royalty obligations for Peyronie’s disease. The amendment enables us to buy down a portion of our future royalty obligations in exchange for an initial cash payment of $1.5 million and five additional cash payments payable upon the occurrence of a milestone event.

As of June 30, 2012, we have capitalized $2.75 million related to this agreement which will be amortized over approximately five years beginning on the date of the first commercial sale of XIAFLEX for the treatment of Peyronie’s disease, which represents the period estimated to be benefited using the straight-line method. In accordance with Accounting Standards Codification 350, Intangibles, Goodwill and Other, 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 ASC 718, 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 an 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 future employee stock-based awards granted, to the extent any such awards are granted.

Further, ASC 718 requires that employee stock-based compensation costs 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, 2012 AND 2011

Revenues

Product Revenues, net

Product revenues include the sales of the collagenase for laboratory use recognized at the time it is shipped to customers. We had a small amount of revenue from the sale of collagenase for laboratory use.  For the three months ended June 30, 2012 and 2011 product revenues were $1,246 and $5,882, respectively. This decrease of $4,636 or 79% was primarily related to the amount of material required to perform testing and additional research by our customers.

Royalties

Royalties consist of royalties and the mark-up on cost of goods sold under the Auxilium Agreement and earn-out revenues associated with the DFB Agreement. Total royalty, mark-up on cost of goods sold and earn-out revenues for the three month period ended June 30, 2012 were $2.5 million as compared to $1.7 million in the 2011 period, an increase of $0.8 million or 46%. Royalty and the mark-up on cost of goods sold revenues recognized under the Auxilium Agreement were $1.5 million for the 2012 period compared to $1.1 million in the 2011 period. The increase of $0.4 million was due to increased net sales of XIAFLEX during 2012 reported to us by Auxilium.
 
 
We receive earn-out revenues from DFB under the earn-out payment provision of the DFB Agreement after certain net sales levels are achieved. Revenues recognized under the DFB Agreement were $0.9 million for the three months ended June 30, 2012 and $0.6 million for the same period in 2011. This increase of $0.3 million was mainly related to the increase in net sales during the 2012 period reported to us by DFB.
 
Licensing Revenue
 
Licensing revenue consists of licensing fees, sublicensing fees and milestones. For the three months ended June 30, 2012 and 2011, we recognized total licensing and milestone revenue of $0.1 million and $3.3 million, respectively, a decrease of $3.2 million. Certain licensing revenues recognized are related to the cash payments received under the Auxilium Agreement in prior years and amortized over the expected development period. Licensing revenue recognized for the three months ended June 30, 2012 and 2011 was $0.1 million in each period. Milestone revenue recognized for the three months ended June 30, 2012 and 2011 was zero and $3.2 million, respectively. In the 2011 period we received and recognized $2.6 million of the $30 million regulatory milestone paid to Auxilium by Pfizer following the first sale of XIAPEX in a major EU market for Dupuytren’s contracture in Europe.  We also received and recognized a milestone of $0.6 million of the $7.5 million paid to Auxilium by Pfizer for the launch in Germany of XIAPEX in the second quarter of 2011.

Under current accounting guidance, nonrefundable upfront license fees for product candidates for which 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.
 
Research and Development Activities and Expenses

Research and development expenses include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expense, facility costs and overhead. Research and development expenses also consist of third party costs, such as medical professional fees, product costs used in clinical trials, consulting fees and costs associated with clinical study arrangements. Research and development expenses were $0.4 million and $0.3 million, respectively, for the three months ended June 30, 2012 and 2011, representing an increase in 2012 of $0.1 million or 49%. This increase in research and development expenses was primarily due to expenses related to our clinical development programs.

We are currently working to develop XIAFLEX for the treatment of human and canine lipoma. We have designed a placebo controlled randomized study to evaluate the efficacy of XIAFLEX for the treatment of subcutaneous benign lipomas in canines. This single injection study will evaluate 32 dogs randomized 1:1 XIAFLEX to placebo. We initiated this trial in the second quarter of 2012. Also, we have designed a phase II dose escalation clinical study of XIAFLEX for the treatment of human lipomas. This study is a single injection, open label trial and is planned to enroll 14 patients with four dosage groups for the treatment of benign subcutaneous lipomas. We initiated this trial in the second quarter of 2012.
 
The following table summarizes our research and development expenses related to our clinical development programs.
 
   
Three Months Ended
June 30, 2012
   
Three Months Ended
June 30, 2011
 
Program
           
Canine Lipoma
  $ 127,510     $ 72,724  
Human Lipoma
  $ 74,155     $ 24,647  

Successful development of drugs is inherently difficult and uncertain.  Our business requires investments in research and development over many years, often for drug candidates that may fail during the research and development process. Even if the Company is able to successfully complete the development of our drug candidates, our long-term prospects depend upon our ability and the ability of our partners, particularly with respect to XIAFLEX, to continue to successfully commercialize these drug candidates.

There is significant uncertainty regarding our ability to successfully develop drug candidates in other indications. These risks include the uncertainty of:
 
 
 
·
the nature, timing and estimated costs of the efforts necessary to complete the development of our drug candidate projects;
 
·
the anticipated completion dates for our drug candidate projects;
 
·
the scope, rate of progress and cost of our clinical trials that we are currently running or may commence in the future with respect to our drug candidate projects;
 
·
the scope, rate of progress of our preclinical studies and other research and development activities related to our drug candidate projects;
 
·
clinical trial results for our drug candidate projects;
 
·
the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights relating to our drug candidate projects;
 
·
the terms and timing of any strategic alliance, licensing and other arrangements that we have or may establish in the future relating to our drug candidate projects;
 
·
the cost and timing of regulatory approvals with respect to our drug candidate projects; and
 
·
the cost of establishing clinical supplies for our drug candidate projects.

Our current resources and liquidity are sufficient to advance our significant current research and development projects and, Auxilium will have the option to exclusively license the canine and human lipoma indications upon completion of the appropriate opt-in study.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and other related costs for personnel, consultant costs, legal fees, investor relations, professional fees and overhead costs. General and administrative expenses were $1.1 million and $1.4 million for the three months ended June 30, 2012 and 2011, respectively, a decrease of approximately $0.3 million, or 19%, from 2011. The decrease in general and administrative expenses was due to lower general legal fees, stock based compensation and consulting services partially offset by third party royalty fees.

Other Income and expense

Other income for the three months ended June 30, 2012 was $9,771 compared to $31,167 in the 2011 period. Other income in the 2012 period consisted of interest earned on our investments of $9,771. Other income in the 2011 period consisted of interest earned on our investments of $16,688 and a refund of tax penalties of $14,479.

Income Taxes

Our deferred tax liabilities, deferred tax assets and related valuation allowances are impacted by events and transactions arising in the ordinary course of business, research and development activities, vesting of nonqualified options, deferred revenues and other items. Deferred tax assets are affected by the valuation allowance which is dependent upon several factors, including estimates of the realization of deferred income tax assets, and the impact of estimated future taxable income. Significant judgment is required to determine the estimated amount of valuation allowance to record. Changes in the estimate of the valuation allowance could materially increase or decrease our provision for income taxes in future periods.

For the three month period ended June 30, 2012 income tax expense was $0.4 million, primarily a non-cash charge. Our income tax expense for the three month period ended June 30, 2012 is based on an estimated effective tax rate derived from an estimate of consolidated earnings before taxes, adjusted for nondeductible expenses and other permanent differences for fiscal year 2012. For the three month period ended June 30, 2012, the valuation allowance with respect to our net deferred tax assets remained unchanged.  As of June 30, 2012, our remaining deferred tax assets decreased by $0.4 million to approximately $2.6 million.

For the three month period ended June 30, 2011 income tax expense was $0.8 million, primarily a non-cash charge as compared to an income tax expense of zero in the 2010 period. In the 2011 period, we recorded an income tax expense of $1.4 partially offset by an increase in deferred tax assets of $0.6 million related to stock-based compensation and orphan drug tax credits. Our income tax expense for the three month period ended June 30, 2011 is based on an estimated effective tax rate derived from an estimate of consolidated earnings before taxes, adjusted for nondeductible expenses and other permanent differences for fiscal year 2011.
 

Net Income

For the three months ended June 30, 2012 we recorded net income of $0.7 million, or $0.11 per basic and $0.10 per diluted common share, compared to a net income of $2.6 million, or $0.40 per basic and $0.36 per diluted common share, for the same period in 2011.

SIX MONTHS ENDED JUNE 30, 2012 AND 2011

Revenues

Product Revenues, net

Product revenues include the sales of the collagenase for laboratory use recognized at the time it is shipped to customers. We had a small amount of revenue from the sale of collagenase for laboratory use.  For the six months ended June 30, 2012 and 2011 product revenues were $8,750 and $11,774, respectively. This decrease of $3,024 or 26% was primarily related to the amount of material required to perform testing and additional research by our customers.

Royalties

Royalties consist of royalties and the mark-up on cost of goods sold under the Auxilium Agreement and earn-out revenues associated with the DFB Agreement. Total royalty, mark-up on cost of goods sold and earn-out revenues for the six month period ended June 30, 2012 were $4.4 million as compared to $2.7 million in the 2011 period, an increase of $1.7 million or 66%. Royalty and the mark-up on cost of goods sold revenues recognized under the Auxilium Agreement were $3.1 million for the 2012 period compared to $1.9 million for the 2011 period. The increase of $1.2 million was due to increased net sales of XIAFLEX during 2012 reported to us by Auxilium.
 
We receive earn-out revenues from DFB under the earn-out payment provision of the DFB Agreement after certain net sales levels are achieved. Revenues recognized under the DFB Agreement were $1.3 million for the six months ended June 30, 2012 and $0.8 million for the same period in 2011. This increase of $0.5 million was mainly related to the increase in net sales during the 2012 period reported to us by DFB.

Licensing Revenue
 
Licensing revenue consists of licensing fees, sublicensing fees and milestones. For the six months ended June 30, 2012 and 2011, we recognized total licensing, sublicensing and milestone revenue of $0.8 million and $4.2 million, respectively, a decrease of $3.4 million or 81%. Certain licensing revenues recognized are related to the cash payments received under the Auxilium Agreement in prior years and amortized over the expected development period. Licensing revenue recognized for the six months ended June 30, 2012 and 2011 was $0.2 million in each period. Sublicensing fees recognized in 2012 were $0.6 million compared to $0.8 million in the same period in 2011. In the 2012 period, sublicensing fees recognized were related to the $10.0 million paid to Auxilium by Actelion for the rights to develop and commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico. In 2011, sublicensing fees recognized were related to the $15.0 million paid to Auxilium by Asahi for the rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Japan.

Milestone revenue recognized for the six months ended June 30, 2012 and 2011 was zero and $3.2 million, respectively. In the 2011 period we received and recognized $2.6 million of the $30 million regulatory milestone paid to Auxilium by Pfizer following the first sale of XIAPEX in a major EU market for Dupuytren’s contracture in Europe.  We recognized a milestone of $0.6 million of the $7.5 million paid to Auxilium by Pfizer for the launch in Germany of XIAPEX in the second quarter of 2011.

Under current accounting guidance, nonrefundable upfront license fees for product candidates for which 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 recognized revenues from consulting and technical assistance contracts primarily as a result of the DFB Agreement. Consulting revenues are recognized ratably over the term of the contract. For the six months ended June 30, 2012 and 2011 consulting fees recognized were zero and $46,667, respectively. The consulting and technical assistance obligations to DFB expired during March 2011.
 
Research and Development Activities and Expenses

Research and development expenses include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expense, facility costs and overhead. Research and development expenses also consist of third party costs, such as medical professional fees, product costs used in clinical trials, consulting fees and costs associated with clinical study arrangements. Research and development expenses were $0.7 million and $0.5 million, respectively, for the six months ended June 30, 2012 and 2011, representing an increase in 2012 of $0.2 million or 35%. This increase in research and development expenses was primarily due to expenses related to our clinical development programs.

We are currently working to develop XIAFLEX for the treatment of human and canine lipoma. We have designed a placebo controlled randomized study to evaluate the efficacy of XIAFLEX for the treatment of subcutaneous benign lipomas in canines. This single injection study will evaluate 32 dogs randomized 1:1 XIAFLEX to placebo. We initiated this trial in the second quarter of 2012. Also, we have designed a phase II dose escalation clinical study of XIAFLEX for the treatment of human lipomas. This study is a single injection, open label trial and is planned to enroll 14 patients with four dosage groups for the treatment of benign subcutaneous lipomas. We initiated this trial in the second quarter of 2012.
 
The following table summarizes our research and development expenses related to our clinical development programs.
 
   
Six Months Ended
June 30, 2012
   
Six Months Ended
June 30, 2011
   
Accumulated Expenses
Since January 1, 2010
 
Program
                 
Canine Lipoma
  $ 209,801     $ 141,141     $ 842,482  
Human Lipoma
  $ 102,433     $ 54,352     $ 650,658  

Successful development of drugs is inherently difficult and uncertain.  Our business requires investments in research and development over many years, often for drug candidates that may fail during the research and development process. Even if the Company is able to successfully complete the development of our drug candidates, our long-term prospects depend upon our ability and the ability of our partners, particularly with respect to XIAFLEX, to continue to successfully commercialize these drug candidates.

There is significant uncertainty regarding our ability to successfully develop drug candidates in other indications. These risks include the uncertainty of:

 
·
the nature, timing and estimated costs of the efforts necessary to complete the development of our drug candidate projects;
 
·
the anticipated completion dates for our drug candidate projects;
 
·
the scope, rate of progress and cost of our clinical trials that we are currently running or may commence in the future with respect to our drug candidate projects;
 
·
the scope, rate of progress of our preclinical studies and other research and development activities related to our drug candidate projects;
 
·
clinical trial results for our drug candidate projects;
 
·
the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights relating to our drug candidate projects;
 
·
the terms and timing of any strategic alliance, licensing and other arrangements that we have or may establish in the future relating to our drug candidate projects;
 
·
the cost and timing of regulatory approvals with respect to our drug candidate projects; and
 
·
the cost of establishing clinical supplies for our drug candidate projects.


Our current resources and liquidity are sufficient to advance our significant current research and development projects and, Auxilium will have the option to exclusively license the canine and human lipoma indications upon completion of the appropriate opt-in study.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and other related costs for personnel, consultant costs, legal fees, investor relations, professional fees and overhead costs. General and administrative expenses were $2.2 million and $2.9 million for the six months ended June 30, 2012 and 2011, respectively, a decrease of $0.7 million, or 24%, from 2011. The decrease in general and administrative expenses was due to lower general legal fees, stock based compensation and consulting services partially offset by third party royalty fees.

Other Income and expense

Other income for the six months ended June 30, 2012 was $19,264 compared to $47,727 in the 2011 period. Other income in the 2012 period consisted of interest earned on our investments. Other income in the 2011 period consisted of interest earned on our investments of $33,248 and a refund of tax penalties of $14,479.
 
Income Taxes

Our deferred tax liabilities, deferred tax assets and related valuation allowances are impacted by events and transactions arising in the ordinary course of business, research and development activities, vesting of nonqualified options, deferred revenues and other items. Deferred tax assets are affected by the valuation allowance which is dependent upon several factors, including estimates of the realization of deferred income tax assets, and the impact of estimated future taxable income. Significant judgment is required to determine the estimated amount of valuation allowance to record. Changes in the estimate of the valuation allowance could materially increase or decrease our provision for income taxes in future periods.

The provision for income taxes and corresponding taxes payable was $0.9 million.   The company paid $0.1 million of cash and applied $0.2 million of its tax refunds receivable to reduce its income taxes payable.  The company also used $0.4 million, of tax assets (primarily Orphan Tax Credit) and availed itself of $0.1 million tax deductible expense related to exercise of stock options to further reduce its tax liability.  Our income tax expense for the six month period ended June 30, 2012 is based on an estimated effective tax rate derived from an estimate of consolidated earnings before taxes, adjusted for nondeductible expenses and other permanent differences for fiscal year 2012. For the six month period ended June 30, 2012, the valuation allowance with respect to our net deferred tax assets remained unchanged.  As of June 30, 2012, our remaining deferred tax assets decreased by $0.4 million to approximately $2.6 million.

For the six month period ended June 30, 2011 net income tax benefit was $2.8 million, primarily a non-cash credit. In the 2011 period, we reduced our tax assets valuation allowance and recorded net deferred tax assets of $4.2 million that we believe will more likely than not be realized as we expect to achieve sustained profitability on an on-going annual basis. In making such determination, we considered all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent financial operations. Included in the valuation adjustment is an increase in the net operating loss carry-forward of approximately $1.0 million which was applied to the current period’s federal and state income taxes, $1.1 million orphan tax credit, $1.6 million stock based deferred tax asset and $0.4 million tax asset from deferred revenues.  We had $2.2 million NOL carryforwards from windfall tax benefits from stock compensation awards and used $0.4 million to reduce taxes payable for the six month period of 2011.  

Net Income

For the six months ended June 30, 2012 we recorded net income of $1.4 million, or $0.22 per basic and $0.20 per diluted common share, compared to a net income of $6.3 million, or $0.99 per basic and $0.87 per diluted common share, for the same period in 2011.

Liquidity and Capital Resources

To date, we have financed our operations primarily through product sales, debt instruments, licensing revenues and royalties under agreements with third parties and sales of our common stock. At June 30, 2012 and December 31, 2011, we had cash and cash equivalents and investments in the aggregate of approximately $8.8 million and $8.2 million, respectively.
 

Net cash provided by operating activities for the six months ended June 30, 2012 was $2.4 million as compared to $2.3 million for the same period in 2011. Cash provided by operations in the 2012 period resulted primarily from the operating income for the period and a payment of earn-out royalties due under the DFB agreement on an annual basis. Cash provided by operations in the 2011 period resulted primarily from the operating income for the period and a payment of earn-out royalties due under the DFB Agreement on an annual basis.

Net cash used in investing activities for the six months ended June 30, 2012 was $1.5 million as compared to zero for the 2011 period. The change reflects the maturing and reinvestment of $2.0 million in marketable securities and a one-time cash payment related to our future royalty obligations for Peyronie's disease of $1.5 million.

Net cash used in financing activities for the six months ended June 30, 2012 was $0.3 million as compared to net cash provided by financing activities of $0.2 million in the comparable period of 2011. In the 2012 period, net cash used in financing activities was mainly due to the repurchase of our common stock under our stock repurchase program during the period partially offset by excess tax benefits related to share-based payments and proceeds received from stock option exercises. In the 2011 period, net cash provided by financing activities was mainly due to excess tax benefits related to share-based payments and proceeds received from stock option exercises partially offset by the repurchase of our common stock under our stock repurchase program during the period.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K.
 
Item 3:
Quantitative and Qualitative Disclosures About Market Risk.

We do not use derivative financial instruments or derivative commodity instruments for trading purposes. Our financial instruments consist of cash, cash equivalents, short-term investments, trade accounts receivable, accounts payable and long-term obligations. We consider investments that, when purchased, have a remaining maturity of 90 days or less to be cash equivalents.

We invest in marketable securities in accordance with our investment policy. The primary objectives of our investment policy are to preserve principal, maintain proper liquidity to meet operating needs and maximize yields. Our investment policy specifies credit quality standards for our investments. The maximum allowable duration of a single issue is eighteen months.

Our investment portfolio is subject to interest rate risk, although limited given the nature of the investments, and will fall in value in the event market interest rates increase. All our cash and cash equivalents and short-term investments at June 30, 2012, amounting to approximately $8.8 million, were maintained in bank demand accounts, money market accounts, and certificates of deposit through the Certificate of Deposit Account Registry Service. We do not hedge our interest rate risks, as we believe reasonably possible near-term changes in interest rates would not materially affect our results of operations, financial position or cash flows.
 
 
We are subject to market risks in the normal course of our business, including changes in interest rates. There have been no significant changes in our exposure to market risks since December 31, 2011.

Item 4.
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 six month period ended June 30, 2012 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II: OTHER INFORMATION

Item 1.
Legal Proceedings

None.

Item 1A.
Risk Factors

There have been no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K filed with the SEC on March 13, 2012.

Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
 
During the six month period ended June 30, 2012, we did not issue any unregistered shares of securities.

Issuer Purchases of Equity Securities (1)

Period
 
Total Number of
Shares
Purchased
During Period(2)
   
Average
 Price Paid
 Per Share (3)
   
Total Number of
Shares
Purchased as
Part of Publicly
Announced Plan
   
Maximum Dollar
Value of Shares
that may yet be
Purchased
under the Plan
(4)
 
January 1, 2011 – March 31, 2011
    0       0       20,608     $ 1,541,999  
April 1, 2011 – June 30, 2011
    8,777     $ 23.51       29,385     $ 1,335,651  
                            $ 2,000,000 (5)
July 1, 2011 – September 30, 2011
    8,981     $ 17.18       38,366     $ 1,845,900  
October 1, 2011 – December 31, 2011
    24,971     $ 15.18       63,337     $ 1,466,796  
January 1, 2012 – March 31, 2012
    12,247     $ 16.24       75,584     $ 1,267,935  
April 1, 2012 – June 30, 2012
    16,340     $ 17.57       91,924     $ 980,841  

 
(1)
On June 4, 2010, we announced that our board of directors authorized a stock repurchase program under Rule 10b-18 of the Exchange Act of up to $2.0 million of our outstanding common stock over a period of 12 months. On June 20, 2011, we announced that our board of directors had reauthorized this stock repurchase program.
 
(2)
The purchases were made in open-market transactions.
 
(3)
Includes commissions paid, if any, related to the stock repurchase transactions.
 
(4)
Represents the difference between the original $2.0 million of stock repurchases authorized by our board of directors on June 4, 2010 less the value of the stock repurchased for the indicated period.
 
(5)
On June 20, 2011, our board of directors reauthorized the repurchase of up to $2.0 million of our common stock under the stock repurchase program.


Item 3.
Defaults Upon Senior Securities

None.

Item 4.
(Removed and Reserved).

Item 5.
Other Information

None.

Item 6.
Exhibits

 
3.1
Registrant’s Certificate of Incorporation, as amended (incorporated by reference to Exhibit 3.1 of the Registrant's Form 10-KSB filed with the SEC on March 2, 2007).
 
3.2
Registrant’s Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 of the Registrant’s Form 10-KSB filed with the SEC on March 2, 2007).
 
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule13a-14(a)/15d-14(a).
 
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of Sarbanes-Oxley Act of 2002.
 
101.INS
XBRL Instance Document
 
101.SCH
XBRL Taxonomy Extension Schema Document
 
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document
 
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document
 
101.LAB
XBRL Taxonomy Extension Label Linkbase Document
 
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document

*
filed herewith
 
 
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 9, 2012
 
/s/ Thomas L. Wegman
 
 
Thomas L. Wegman
 
 
President, Principal Executive Officer and Principal Financial Officer
 
 
27

EX-31 2 ex31.htm EXHIBIT 31 ex31.htm

Exhibit 31

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL 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, 2012 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 9, 2012
 
   
/s/ Thomas L. Wegman
 
 Thomas L. Wegman
 
 President, Principal Executive Officer and Principal Financial Officer
 

 


EX-32 3 ex32.htm EXHIBIT 32 ex32.htm

Exhibit 32

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER AND 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, 2012 (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 9th day of August, 2012.

/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, as amended (the “Exchange Act”) 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, as amended, or the Exchange Act, 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.
 
 

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Fair values identified by Level 3 inputs are unobservable data points and are used to measure fair value to the extent that observable inputs are not available. Unobservable inputs reflect our own assumptions about the assumptions that market participants would use in pricing the asset or liability.</div></div></div> P1Y P8Y 17000 156883 127863 382076 318280 52000 14000 42000 1149926 1418016 2238648 2927542 1057333 3351176 2315300 3503059 <div><div style="text-align: justify; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt; font-weight: bold;">7. INCOME TAXES</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;"><font style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">The significant components of the Company's deferred tax assets, pursuant to Accounting Standards Codification 740-10-50 consist of </font>net operating losses, orphan tax credits, stock-based compensation and deferred revenues. 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PATENT COSTS</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, ranging from 1 to 8 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.</div><div><br /></div><div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;"><font style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">As of June 30, 2012, the Company capitalized certain patent costs, paid by Auxilium on behalf of the Company. These costs are reimbursable to Auxilium under </font>the Auxilium Agreement<font style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;"> and are creditable against future royalty revenues. 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font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">&#160;</div></div></td><td valign="bottom" style="padding-bottom: 2px;"><div>&#160;</div></td><td colspan="2" valign="bottom" style="border-bottom: #000000 2px solid;"><div><div style="text-align: center; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt; font-weight: bold;">2012</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; padding-bottom: 2px;"><div>&#160;</div></td><td valign="bottom" style="padding-bottom: 2px;"><div>&#160;</div></td><td colspan="2" valign="bottom" style="border-bottom: #000000 2px solid;"><div><div style="text-align: center; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt; font-weight: bold;">2011</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; padding-bottom: 2px;"><div>&#160;</div></td></tr><tr style="background-color: #cceeff;"><td valign="bottom" style="width: 76%;"><div><div style="text-align: left; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">Patents</div></div></td><td valign="bottom" style="width: 1%;"><div>&#160;</div></td><td valign="bottom" style="text-align: left; width: 1%;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">$</div></div></td><td valign="bottom" style="text-align: right; width: 9%;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">382,076</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; width: 1%;"><div>&#160;</div></td><td valign="bottom" style="width: 1%;"><div>&#160;</div></td><td valign="bottom" style="text-align: left; width: 1%;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">$</div></div></td><td valign="bottom" style="text-align: right; width: 9%;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">318,280</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; width: 1%;"><div>&#160;</div></td></tr><tr style="background-color: #ffffff;"><td valign="bottom" style="padding-bottom: 2px; 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text-align: right; width: 9%;"><div><div style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">(127,863</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; padding-bottom: 2px; width: 1%;"><div style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">)</div></td></tr><tr style="background-color: #cceeff;"><td valign="bottom" style="padding-bottom: 4px; width: 76%;"><div><div style="text-align: left; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">&#160;</div></div></td><td valign="bottom" style="padding-bottom: 4px; width: 1%;"><div>&#160;</div></td><td valign="bottom" style="border-bottom: #000000 4px double; text-align: left; width: 1%;"><div><div style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">$</div></div></td><td valign="bottom" style="border-bottom: #000000 4px double; text-align: right; width: 9%;"><div><div style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">225,193</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; padding-bottom: 4px; width: 1%;"><div>&#160;</div></td><td valign="bottom" style="padding-bottom: 4px; width: 1%;"><div>&#160;</div></td><td valign="bottom" style="border-bottom: #000000 4px double; text-align: left; width: 1%;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">$</div></div></td><td valign="bottom" style="border-bottom: #000000 4px double; text-align: right; width: 9%;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">190,417</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; padding-bottom: 4px; width: 1%;"><div>&#160;</div></td></tr></table></div></div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;"><font style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">The amortization expense for patents for six months ended June 30, 2012 was approximately $29,000. </font>In the comparable period of 2011, <font style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">the amortization expense for patents was approximately $21,000. 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The amendments in ASU 2011-04 do not modify the requirements for when fair value measurements apply; rather, they generally represent clarifications on how to measure and disclose fair value under ASC 820, Fair Value Measurement. The amendments in the ASU 2011-04 are effective prospectively for interim and annual periods beginning after December&#160;15, 2011. Early adoption is not permitted for public entities. Adoption of this standard did not have a material impact on the financial statements.</div><div style="text-align: justify; margin-top: 12pt; font-family: 'Times New Roman', serif; margin-bottom: 12pt; font-size: 10pt;">In June 2011, the FASB issued Accounting Standards Update No. 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income ("ASU 2011-05") Under ASU 2011-05, an entity is required to present comprehensive income on the income statement or as a separate financial statement. ASU 2011-05 is effective January 1, 2012. ASU 2011-05 affects financial statement presentation only and has no effect on results of operations or financial position.&#160; We adopted this new guidance effective March 31, 2012<font style="font-family: 'Times New Roman', serif; font-size: 10pt;">&#160;and chose to use the two separate but consecutive</font> statements<font style="font-family: 'Times New Roman', serif; font-size: 10pt;"><strike>.</strike></font><font style="font-family: 'Times New Roman', serif; font-size: 10pt;"> presentation approach</font>.</div></div></div> 9771 31167 19264 47727 1047562 3320009 2296036 3455332 11250 <div><div style="text-align: justify; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt; font-weight: bold;">1. ORGANIZATION AND DESCRIPTION OF BUSINESS</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">We are a biopharmaceutical company involved in the development of an injectable collagenase for multiple indications. We are a party to a development and license agreement with Auxilium Pharmaceuticals, Inc. ("Auxilium") for injectable collagenase (which Auxilium has named XIAFLEX<sup>&#174;</sup> (collagenase clostridium histolyticum)) for clinical indications in Dupuytren's contracture, Peyronie's disease and frozen shoulder (<font style="font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt;">adhesive capsulitis</font>). Auxilium has an option to acquire additional indications that we may pursue, including cellulite, for which we have granted Auxilium the right to initiate early development studies at its cost, and human and canine lipoma. Auxilium is currently selling XIAFLEX in the U.S. for the treatment of Dupuytren's contracture. Auxilium has an agreement with Pfizer, Inc. ("Pfizer") pursuant to which Pfizer has the right to market XIAFLEX for Dupuytren's contracture and Peyronie's disease in Europe and certain Eurasian countries, and will do so under the registered trademark XIAPEX<sup>&#174;</sup> (collagenase clostridium histolyticum).&#160;Pfizer received marketing authorization for Dupuytren's contracture by the European Commission on February 28, 2011 and began sales in certain countries in the European Union in April 2011. In addition, Auxilium has an agreement with Asahi Kasei Pharma Corporation ("Asahi") pursuant to which Asahi has the right to commercialize XIAFLEX for the treatment of Duputyren's contracture and Peyronie's disease in Japan. Auxilium also has an agreement with Actelion Pharmaceuticals Ltd. ("Actelion") pursuant to which Actelion has the right to commercialize XIAFLEX for the treatment of Duputyren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico. Actelion was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Pursuant to a March 2006 agreement (the "DFB Agreement") between the Company and DFB Biotech, Inc. ("DFB"), we continue to receive earn-out payments based on the sales of Santyl. &#160;Our right to receive earn-out payments with respect to the marketed topical product sold to DFB expires in June 2013, but earn-out payments for second generation collagenase products, if any, continue indefinitely.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Operational Highlights</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">On May 7, 2012, we announced the initiation of a placebo controlled randomized Phase II clinical trial, Chien-804, to evaluate the efficacy of XIAFLEX for canines with benign subcutaneous lipomas. The single injection study will evaluate 32 dogs randomized 1:1 XIAFLEX to placebo. Auxilium has the option to license development and marketing rights to this canine lipoma indication.&#160; We anticipate that we will complete enrollment by the first half of 2013.</div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">&#160;</div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">In a May 9, 2012 press release, Auxilium announced that <font style="font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt;">The Journal of Urology</font> had published on its website, Auxilium's phase IIb clinical trial of XIAFLEX for the potential nonsurgical treatment of Peyronie's disease. &#160;Top line data from this trial had been previously reported by Auxilium. The study appeared in the June 2012 print version of <font style="font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt;">The Journal of Urology</font>.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">On June 4, 2012, we announced positive top-line results from the IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) Phase III clinical program of XIAFLEX for the treatment of Peyronie's disease, which was conducted by our partner Auxilium. Results from the two randomized, double-blind, placebo-controlled studies at 52 weeks demonstrated statistically significant improvements in both co-primary endpoints of the trials, including percent improvement from baseline in penile curvature deformity compared to placebo and change from baseline (improvement) in the Peyronie's disease bother domain of Auxilium's Peyronie's Disease Questionnaire ("PDQ") compared to placebo. Auxilium expects to submit a supplemental Biologics License Application ("sBLA") filing to the U.S. Food and Drug Administration ("FDA") by the end of 2012.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">On June 26, 2012, we announced that we initiated a Phase II trial of XIAFLEX for the treatment of human lipoma. Human lipomas are encapsulated deposits of benign fat often detected as bulges under the skin and are diagnosed in 575,000 U.S. patients annually. We anticipate that we will complete enrollment by the first half of 2013.</div><div style="text-align: justify; margin-top: 12pt; font-family: 'Times New Roman', serif; margin-bottom: 12pt; font-size: 10pt;">In a July 9, 2012 press release, Auxilium and Actelion announced that Auxilium was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada. Under the terms of the Collaboration Agreement between Actelion and Auxilium, Actelion received exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Pursuant to the Collaboration Agreement, Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion and Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in Canada and, upon approval, in the remainder of these countries. Actelion expects to make XIAFLEX available to patients in Canada in the first half of 2013.</div><div style="text-align: justify; margin-top: 12pt; font-family: 'Times New Roman', serif; margin-bottom: 12pt; font-size: 10pt;">In a July 30, 2012 press release, Auxilium announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords.&#160; Auxilium enrolled 60 patients at eight sites throughout the U.S. and Australia.&#160; In the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the Company to seek FDA approval and expansion of the Dupuytren's label.&#160; Based on research by SDI Health, LLC estimating that 35 to 40% of annual Dupuytren's surgeries in the US are performed to treat two or more cords concurrently, Auxilium is conducting these studies to seek a multicord indication for XIAFLEX from the FDA.&#160; Auxilium expects topline results in the first half of 2014.</div></div> <div><div style="text-align: justify; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt; font-weight: bold;">2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES</div><div><br /></div><div><div><div style="text-align: justify; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt; font-weight: bold;">Basis of Presentation</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">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 U.S. generally accepted accounting principles ("U.S. GAAP") has been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the "SEC") for quarterly reporting.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;"><font style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">The information included in this Report should be read in conjunction with </font>our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 and our <font style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">Annual Report on Form 10-K for the year ended December 31, 2011 filed with the SEC on May 10, 2012 and March 13, 2012, respectively.</font></div></div></div><div><br /></div><div><div><div style="text-align: left; font-family: 'Times New Roman', serif; margin-bottom: 12pt; font-size: 10pt; font-weight: bold;">Principles of Consolidation</div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">The audited consolidated financial statements include the accounts of the Company and its subsidiary, ABC-NY.</div></div></div><div><br /></div><div><div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Critical Accounting Policies, Estimates and Assumptions</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">The preparation of consolidated financial statements in conformity with U.S. GAAP 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 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. Actual results could differ from those estimates.</div></div></div><div><br /></div><div><div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Cash, Cash Equivalents and Short-term Investments</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Cash, cash equivalents and short-term investments are stated at market value. Cash equivalents include only securities having a maturity of three months or less at the time of purchase. 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This Codification topic identifies two kinds of inputs that are used to determine the fair value of assets and liabilities: observable and unobservable. Observable inputs are based on market data or independent sources while unobservable inputs are based on our own market assumptions. Once inputs have been characterized, this Codification topic requires us to prioritize the inputs used to measure fair value into one of three broad levels. Fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values identified by Level 2 inputs utilize observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities. Fair values identified by Level 3 inputs are unobservable data points and are used to measure fair value to the extent that observable inputs are not available. 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font-family: 'Times New Roman', serif; font-size: 10pt;">Revenue Recognition</font> ("ASC 605").</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">If we determine that separate elements exist in a revenue arrangement under ASC 605, 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.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Revenues, and their respective treatment for financial reporting purposes, are as follows:</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Product Sales</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">We recognize revenue from product sales of lab reagents 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.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Net sales include the sales of the collagenase for laboratory use that are recognized at the time the product is shipped to customers for laboratory use.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Royalty / Mark-up on Cost of Goods Sold / Earn-Out Revenue</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">For those arrangements for which royalty, mark-up on cost of goods sold or earn-out payment information becomes available and collectability is reasonably assured, we recognize revenue during the applicable period earned. For interim quarterly reporting purposes, when collectability is reasonably assured but a reasonable estimate of royalty, mark-up on cost of goods sold or earn-out payment revenues cannot be made, the royalty, mark-up on cost of goods sold and earn-out payment revenues are generally recognized in the quarter that the applicable licensee provides the written report and sufficient related information to us.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Under our development and license agreement with Auxilium (as amended and restated on each of December 11, 2008 and August 31, 2011, the "Auxilium Agreement"), we do not participate in the selling, marketing or manufacturing of products for which we receive royalties and a mark-up of the cost of goods sold revenues. The royalty and mark-up on cost of goods sold revenues will generally be recognized in the quarter that Auxilium provides the written reports and related information to us, that is, royalty and mark up on cost of goods sold revenues are generally recognized one quarter following the quarter in which sales by Auxilium occurred.<font style="font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">&#160;</font>The royalties payable by Auxilium to us are subject to set-off for certain patent costs.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Under a March 2006 agreement (the "DFB Agreement"), pursuant to which we sold our topical collagenase business to DFB Biotech, Inc. and its affiliates ("DFB"), we have the right to receive earn-out payments in the future based on sales of certain products. &#160;Generally, under the DFB Agreement we would receive payments and a report within ninety (90) days from the end of each calendar year after DFB has sold the royalty-bearing product. Currently, DFB is providing us earn-out reports on a quarterly basis.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">License Revenue</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">We include revenue recognized from upfront licensing, sublicensing and milestone payments in "License Revenues" in our consolidated statements of operations in this Report.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt;">Upfront License and Sublicensing Fees</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">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.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt;">Milestones</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">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.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">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 U.S. Food and Drug Administration 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.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Consulting and Technical Assistance Services</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">We recognize revenues from consulting and technical assistance contracts primarily as a result of the DFB Agreement. Consulting revenues are recognized ratably over the term of the contract. The consulting and technical assistance obligations to DFB expired in March 2011.</div></div></div><div><div><div style="text-align: left; margin-top: 9pt; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Treasury Stock</div><div style="text-align: justify; margin-top: 4.5pt; font-family: 'Times New Roman', serif; font-size: 10pt;">The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders' equity.</div></div></div><div><br /></div><div><div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Accounts receivable and Allowance for Doubtful Accounts</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Trade accounts receivable are stated at the amount the Company expects to collect. We maintain allowances for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. We consider the following factors when determining the collectability of specific customer accounts: customer credit-worthiness, past transaction history with the customer, current economic industry trends, and changes in customer payment terms.&#160;&#160;Our accounts receivable balance is typically due from its two large pharmaceutical customers.&#160;&#160;These companies have historically paid timely and have been financially stable organizations.&#160;&#160;Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.&#160;&#160;If the financial condition of our customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required.&#160;&#160;We provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after we have used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable.&#160;&#160;We recorded no material bad debt expense in the quarter ended June 30, 2012.&#160;&#160;The allowance for doubtful accounts balance as of June 30, 2012 and 2011 was $30,095.</div><div style="text-align: justify; margin-top: 12pt; font-family: 'Times New Roman', serif; margin-bottom: 12pt; font-size: 10pt;">Accounts receivable as of June 30, 2012 is approximately $2.8 million, which consists of approximately $1.3 million due from DFB in accordance with the earn-out under the DFB Agreement and approximately $1.5 million in royalties due from Auxilium in accordance with the terms of the Auxilium Agreement.</div></div></div><div><div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Reimbursable Third Party Development Costs</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">We accrue expenses for research and development that are reimbursable by us under the Auxilium Agreement. &#160;We capitalize certain patent costs related to estimated third party development costs that are reimbursable under the Auxilium Agreement. In August 2011, through the amendment and restatement of our development and license agreement with Auxilium, we have clarified the rights and responsibilities of the joint development of XIAFLEX. We resolved what had been an on-going dispute with Auxilium concerning the appropriate amount of creditable third party development expenses related to the lyophilization of the injection formulation and certain patent expenses for research and development costs that were reimbursable under the Auxilium Agreement. We do not expect any additional third party development cost related to the lyophilization of the injection formulation. &#160;Any estimates of patent costs are based on contractual terms, historical costs, reviewing third party data and expectations regarding future development for certain products.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">If conditions or other circumstances change, we may take actions to revise our reimbursable third party patent cost estimates. These revisions could result in an incremental increase or decrease in research and development costs. For example, the Auxilium Agreement provides that Auxilium and BioSpecifics will share equally certain patent expenses which <font style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">are creditable against future royalty revenues</font>.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">As of June 30, 2012 our net reimbursable third party patent costs accrual was approximately $74,000.</div></div></div><div><br /></div><div><div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Research and Development Expenses</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Research and development ("R&amp;D") <font style="font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">expenses </font>include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expense, facility costs and overhead. R&amp;D expenses also consist of third party costs, such as medical professional fees, product costs used in clinical trials, consulting fees and costs associated with clinical study arrangements. We may fund R&amp;D at medical research institutions under agreements that are generally cancelable. All of these costs are charged to R&amp;D as incurred, which may be measured by percentage of completion, contract milestones, patient enrollment, or the passage of time.</div></div></div><div><br /></div><div><div><div style="text-align: left; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Clinical Trial Expenses</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">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.</div></div></div><div><br /></div><div><div><div style="text-align: justify; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt; font-weight: bold;">Stock-Based Compensation</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">The Company has two stock-based compensation plans in effect. Accounting Standards Codification 718, <font style="font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt;">Compensation - Stock Compensation </font>("ASC 718") requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based awards including stock options and common stock issued to our employees and directors under our stock plans. It requires companies to estimate the fair value of share-based awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service periods in our consolidated statements of operations.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Under the ASC 718, 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 an award. 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padding-bottom: 2px; vertical-align: bottom;"><div>&#160;</div></td><td valign="bottom" style="padding-bottom: 2px; vertical-align: bottom;"><div>&#160;</div></td><td colspan="2" valign="bottom" style="border-bottom: #000000 2px solid; vertical-align: bottom;"><div><div style="text-align: center; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">2011</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; padding-bottom: 2px; vertical-align: bottom;"><div>&#160;</div></td></tr><tr style="background-color: #cceeff;"><td valign="bottom" style="width: 52%;"><div><div style="text-align: left; font-family: 'Times New Roman', serif; font-size: 10pt;">&#160;&#160;&#160;&#160;&#160;Research and development</div></div></td><td valign="bottom" style="width: 1%; vertical-align: bottom;"><div>&#160;</div></td><td valign="bottom" style="text-align: left; width: 1%; vertical-align: bottom;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">$</div></div></td><td valign="bottom" style="text-align: right; 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color: #000000; font-size: 10pt;">The aggregate intrinsic value of options outstanding and exercisable as of June 30, 2012 was approximately $13.2 million. 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We may fund R&amp;D at medical research institutions under agreements that are generally cancelable. 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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.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Net sales include the sales of the collagenase for laboratory use that are recognized at the time the product is shipped to customers for laboratory use.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Royalty / Mark-up on Cost of Goods Sold / Earn-Out Revenue</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">For those arrangements for which royalty, mark-up on cost of goods sold or earn-out payment information becomes available and collectability is reasonably assured, we recognize revenue during the applicable period earned. For interim quarterly reporting purposes, when collectability is reasonably assured but a reasonable estimate of royalty, mark-up on cost of goods sold or earn-out payment revenues cannot be made, the royalty, mark-up on cost of goods sold and earn-out payment revenues are generally recognized in the quarter that the applicable licensee provides the written report and sufficient related information to us.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Under our development and license agreement with Auxilium (as amended and restated on each of December 11, 2008 and August 31, 2011, the "Auxilium Agreement"), we do not participate in the selling, marketing or manufacturing of products for which we receive royalties and a mark-up of the cost of goods sold revenues. The royalty and mark-up on cost of goods sold revenues will generally be recognized in the quarter that Auxilium provides the written reports and related information to us, that is, royalty and mark up on cost of goods sold revenues are generally recognized one quarter following the quarter in which sales by Auxilium occurred.<font style="font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">&#160;</font>The royalties payable by Auxilium to us are subject to set-off for certain patent costs.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Under a March 2006 agreement (the "DFB Agreement"), pursuant to which we sold our topical collagenase business to DFB Biotech, Inc. and its affiliates ("DFB"), we have the right to receive earn-out payments in the future based on sales of certain products. &#160;Generally, under the DFB Agreement we would receive payments and a report within ninety (90) days from the end of each calendar year after DFB has sold the royalty-bearing product. 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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.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt;">Milestones</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">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.</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">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 U.S. Food and Drug Administration or other regulatory agencies require additional data or information, we would adjust our development period estimates accordingly. 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color: #000000; font-size: 10pt;">225,193</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; padding-bottom: 4px; width: 1%;"><div>&#160;</div></td><td valign="bottom" style="padding-bottom: 4px; width: 1%;"><div>&#160;</div></td><td valign="bottom" style="border-bottom: #000000 4px double; text-align: left; width: 1%;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">$</div></div></td><td valign="bottom" style="border-bottom: #000000 4px double; text-align: right; width: 9%;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">190,417</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; padding-bottom: 4px; width: 1%;"><div>&#160;</div></td></tr></table></div></div> <div><div style="text-align: justify; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt;">The following table summarizes the number of common equivalent shares that were included for the calculation of diluted net income purposes from continuing operations reported in the consolidated statement of operations.</div><div><table cellpadding="0" cellspacing="0" style="width: 100%; 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vertical-align: bottom;"><div>&#160;</div></td><td colspan="2" valign="bottom" style="border-bottom: #000000 2px solid; vertical-align: bottom;"><div><div style="text-align: center; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">2011</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; padding-bottom: 2px; vertical-align: bottom;"><div>&#160;</div></td><td valign="bottom" style="padding-bottom: 2px; vertical-align: bottom;"><div>&#160;</div></td><td colspan="2" valign="bottom" style="border-bottom: #000000 2px solid; vertical-align: bottom;"><div><div style="text-align: center; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">2012</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; padding-bottom: 2px; vertical-align: bottom;"><div>&#160;</div></td><td valign="bottom" style="padding-bottom: 2px; vertical-align: bottom;"><div>&#160;</div></td><td colspan="2" valign="bottom" style="border-bottom: #000000 2px solid; 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padding-bottom: 2px; vertical-align: bottom;"><div>&#160;</div></td></tr><tr style="background-color: #cceeff;"><td valign="bottom" style="width: 52%;"><div><div style="text-align: left; font-family: 'Times New Roman', serif; font-size: 10pt;">&#160;&#160;&#160;&#160;&#160;Research and development</div></div></td><td valign="bottom" style="width: 1%; vertical-align: bottom;"><div>&#160;</div></td><td valign="bottom" style="text-align: left; width: 1%; vertical-align: bottom;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">$</div></div></td><td valign="bottom" style="text-align: right; width: 9%; vertical-align: bottom;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">122,679</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; width: 1%; vertical-align: bottom;"><div>&#160;</div></td><td valign="bottom" style="width: 1%; vertical-align: bottom;"><div>&#160;</div></td><td valign="bottom" style="text-align: left; width: 1%; vertical-align: bottom;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">$</div></div></td><td valign="bottom" style="text-align: right; width: 9%; vertical-align: bottom;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">25,457</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; width: 1%; vertical-align: bottom;"><div>&#160;</div></td><td valign="bottom" style="width: 1%;"><div>&#160;</div></td><td valign="bottom" style="text-align: left; width: 1%;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">$</div></div></td><td valign="bottom" style="text-align: right; width: 9%;"><div><div style="font-family: 'Times New Roman', serif; font-size: 10pt;">144,817</div></div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; width: 1%;"><div>&#160;</div></td><td valign="bottom" style="width: 1%;"><div>&#160;</div></td><td valign="bottom" style="text-align: left; width: 1%;"><div><div style="font-family: 'Times New Roman', serif; 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Accounting Standards Codification 718, <font style="font-style: italic; font-family: 'Times New Roman', serif; font-size: 10pt;">Compensation - Stock Compensation </font>("ASC 718") requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based awards including stock options and common stock issued to our employees and directors under our stock plans. It requires companies to estimate the fair value of share-based awards on the date of grant using an option-pricing model. 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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.</div></div></div> 5000000 5000000 109000 24000 16151219 14872314 <div><div style="text-align: justify; font-family: 'Times New Roman', serif; color: #000000; font-size: 10pt; font-weight: bold;">9. SUBSEQUENT EVENTS</div><div style="text-align: justify; margin-top: 12pt; font-family: 'Times New Roman', serif; margin-bottom: 12pt; font-size: 10pt;">In a July 9, 2012 press release, Auxilium and Actelion announced that Auxilium was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada. Under the terms of the Collaboration Agreement between Actelion and Auxilium, Actelion received exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Pursuant to the Collaboration Agreement, Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion and Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in Canada and, upon approval, in the remainder of these countries. Actelion expects to make XIAFLEX available to patients in Canada in the first half of 2013.</div><div style="text-align: justify; margin-top: 12pt; font-family: 'Times New Roman', serif; margin-bottom: 12pt; font-size: 10pt;">In a July 30, 2012 press release, Auxilium announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords.&#160; Auxilium enrolled 60 patients at eight sites throughout the U.S. and Australia.&#160; In the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the Company to seek FDA approval and expansion of the Dupuytren's label.&#160; Based on research by SDI Health, LLC estimating that 35 to 40% of annual Dupuytren's surgeries in the U.S. are performed to treat two or more cords concurrently, Auxilium is conducting these studies to seek a multicord indication for XIAFLEX from the FDA<font style="font-family: 'Times New Roman', serif; font-size: 10pt;">. &#160;Auxilium expects topline results in the first half of 2014</font>.</div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">We have evaluated subsequent events for recognition or disclosure through the time of filing these consolidated financial statements on Form 10-Q with the U.S. Securities and Exchange Commission on August 9, 2012.</div></div> 2012-07-30 102471 0 <div><div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt; font-weight: bold;">Accounts receivable and Allowance for Doubtful Accounts</div><div><br /></div><div style="text-align: justify; font-family: 'Times New Roman', serif; font-size: 10pt;">Trade accounts receivable are stated at the amount the Company expects to collect. We maintain allowances for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. 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These estimates are based on historical experience and on various other assumptions that we believe are reasonable under the circumstances. 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In August 2011, through the amendment and restatement of our development and license agreement with Auxilium, we have clarified the rights and responsibilities of the joint development of XIAFLEX. We resolved what had been an on-going dispute with Auxilium concerning the appropriate amount of creditable third party development expenses related to the lyophilization of the injection formulation and certain patent expenses for research and development costs that were reimbursable under the Auxilium Agreement. 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Subsequent Event Type [Axis] Subsequent Event [Table] Subsequent Event [Member] Subsequent event date Supplemental disclosures of cash flow information: Accrued tax liability Accounts receivable and Allowance for Doubtful Accounts Treasury stock, 223,191 and 194,604 shares at cost at June 30, 2012 and December 31, 2011, respectively Treasury Stock, Value Treasury stock, shares (in shares) Critical Accounting Policies, Estimates and Assumptions Number of common equivalent shares included for the calculation of diluted net income [Abstract] Shares used in computation of basic net income per share (in shares) Shares used in computation of diluted net income per share (in shares) The cash outflow from the purchase of royalty interests in various agreements with investigators, universities and other entities. Payment for royalty buy down Payment for royalty buy down Cash paid during the year for [Abstract] Cash paid during the year for: Accrued patent costs creditable against future royalties during the period. Patent costs accrued from Auxilium Reflects the sum of all other revenue , income and expense recognized by the entity in the period not otherwise specified in the income statement. Other Income Expense Other income (expense) The number of countries where goods are sold. Number of countries where product is sold Number of European countries where XIAFLEX is selling Document and Entity Information [Abstract] The number of dogs on which single injection study evaluate. Number Of Dogs On Which Single Injection Study Evaluate Number of dogs on which single injection study evaluate The ratio of injectable collagenase to placebo. Ratio Of Injectable Collagenase To Placebo As Multiple Ratio of XIAFLEX to placebo Number of randomized, double-blind, placebo-controlled studies of IMPRESS Phase III clinical program of XIAFLEX conducted by Auxilium. Number of randomized, double-blind, placebo-controlled studies of IMPRESS Phase III clinical program of XIAFLEX conducted by Auxilium Period over which studies of IMPRESS Phase III clinical program of XIAFLEX were conducted by Auxilium. Period over which studies of IMPRESS Phase III clinical program of XIAFLEX were conducted by Auxilium Period over which studies of IMPRESS Phase III clinical program of XIAFLEX were conducted by Auxilium (in weeks) Number of U.S. patients diagnosed with human lipomas annually. Number of U.S. patients diagnosed with human lipomas annually Number of patients anticipated to participate in the single center dose escalation study of Phase II trial of XIAFLEX for treatment of human lipoma. Number of patients anticipated to participate in single center dose escalation study of Phase II trial of XIAFLEX for treatment of human lipoma Number of patients enrolled for open-label phase IIIb trial by Auxilium. Number of patients enrolled for open-label phase IIIb trial by Auxilium Number of sites throughout U.S. and Australia at which patients were enrolled for open-label phase IIIb trial. Number of sites throughout U.S. and Australia at which patients were enrolled for open-label phase IIIb trial Percentage of annual Dupuytren's surgeries in the US performed to treat two or more cords concurrently. Percentage of annual Dupuytren's surgeries in the US performed to treat two or more cords concurrently Percentage of annual Dupuytren's surgeries in the US performed to treat two or more cords concurrently (in hundredths) Minimum number of cords treated concurrently in Dupuytren's surgeries. Number of cords treated concurrently in Dupuytren's surgeries, minimum Disclosure of accounting policy for treasury stock. Treasury Stock [Policy Text Block] Treasury Stock Disclosure of accounting policy for reimbursable third party development costs. Reimbursable Third Party Development Costs [Policy Text Block] Reimbursable Third Party Development Costs Disclosure of accounting policy for clinical trial expenses. Clinical Trial Expenses [Policy Text Block] Clinical Trial Expenses Royalty Mark up on Cost of Goods Sold Earn Out Revenue [Abstract] Royalty / Mark-up on Cost of Goods Sold / Earn-Out Revenue [Abstract] The number of quarters after which revenue is recognized following the quarter in which sales is occurred. Number of quarters after which revenue is recognized Number of quarters after which revenue is recognized (in quarters) The number of days after calendar year after which payments and report are received. Number of days after calendar year after which payments and report are received Number of days after calendar year, after which payments and report are received (in days) This line item represents one of the major pharmaceutical customer of the entity from which a large part of revenue is generated. DFB Biotech Inc [Member] This line item represents one of the major pharmaceutical customer of the entity from which a large part of revenue is generated. Auxilium [Member] Accounts receivable and Allowance for Doubtful Accounts [Abstract] Accounts receivable and Allowance for Doubtful Accounts [Abstract] The number of major customers of the entity. Number of major customers Reimbursable Third Party Development Costs [Abstract] Reimbursable Third Party Development Costs [Abstract] Carrying value as of the balance sheet date of obligations incurred through that date and payable for patents. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Accrued patent costs The number of stock-based compensation plans that an entity have for its employees. Number of share based compensation plans Number of stock-based compensation plans in effect Share based compensation stock options activity [Abstract] The price of common stock on the balance sheet date. Closing price of common stock Closing price of common stock (in dollars per share) Carrying value as of the balance sheet date of obligations incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business and pertaining to costs that are statutory in nature, are incurred on contractual obligations, or accumulate over time and for which invoices have not yet been received or will not be rendered. Examples include taxes, interest, rent and utilities. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Trade accounts payable and accrued expenses Sum of the carrying values as of the balance sheet date of obligations incurred through that date and due within one year (or the operating cycle, if longer), including liabilities incurred (and for which invoices have typically been received) and payable, excluding accrued tax liability. Accounts Payable and Accrued Liabilities, Excluding Accrued Tax Liability, Current Total Amount of amortization expense expected to be recognized after the fourth fiscal year following the latest fiscal year for assets, excluding financial assets and goodwill, lacking physical substance with a finite life. 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ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) (USD $)
Jun. 30, 2012
Dec. 31, 2011
Accounts payable and accrued expenses [Abstract]    
Trade accounts payable and accrued expenses $ 448,362 $ 407,954
Accrued legal and other professional fees 64,379 50,000
Accrued payroll and related costs 147,023 143,048
Total $ 659,764 $ 601,002

XML 13 R9.htm IDEA: XBRL DOCUMENT v2.4.0.6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
6 Months Ended
Jun. 30, 2012
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
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 U.S. generally accepted accounting principles ("U.S. GAAP") has been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the "SEC") for quarterly reporting.

The information included in this Report should be read in conjunction with our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 and our Annual Report on Form 10-K for the year ended December 31, 2011 filed with the SEC on May 10, 2012 and March 13, 2012, respectively.

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

Critical Accounting Policies, Estimates and Assumptions

The preparation of consolidated financial statements in conformity with U.S. GAAP 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 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. Actual results could differ from those estimates.

Cash, Cash Equivalents and Short-term Investments

Cash, cash equivalents and short-term investments 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 short-term investments by placing its investments with banks it believes are highly creditworthy and with highly rated money market funds, U.S. government securities, or certificates of deposit.

Fair Value Measurements
 
 
 
The Fair Value Measurements and Disclosures Topic of the Accounting Standards Codification defines fair value, establishes a framework for measuring fair value in applying generally accepted accounting principles, and expands disclosures about fair value measurements. This Codification topic identifies two kinds of inputs that are used to determine the fair value of assets and liabilities: observable and unobservable. Observable inputs are based on market data or independent sources while unobservable inputs are based on our own market assumptions. Once inputs have been characterized, this Codification topic requires us to prioritize the inputs used to measure fair value into one of three broad levels. Fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values identified by Level 2 inputs utilize observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities. Fair values identified by Level 3 inputs are unobservable data points and are used to measure fair value to the extent that observable inputs are not available. Unobservable inputs reflect our own assumptions about the assumptions that market participants would use in pricing the asset or liability.

The following table presents information about our assets and liabilities that are measured at fair value on a recurring basis for the period presented and indicates the fair value hierarchy of the valuation techniques we utilized to determine such fair value.
 
 
 
 
June 30, 2012
 
Fair Value
 
 
Quoted Prices in
Active Markets for
Identical Assets
Level 1
 
 
Significant
Other Observable
Inputs
Level 2
 
Significant
Unobservable
Inputs
Level 3
Cash and cash equivalents
 
3,788,173
 
 
$
3,788,173
 
 
 
-
 
  
 
-
Certificates of Deposit
 
 
5,000,000
 
 
 
5,000,000
 
 
 
-
 
  
 
-

Revenue Recognition

We currently recognize revenues resulting from product sales, the licensing and sublicensing of the use of our technology and from services we sometimes perform in connection with the licensed technology under the guidance of Accounting Standards Codification 605, Revenue Recognition ("ASC 605").

If we determine that separate elements exist in a revenue arrangement under ASC 605, 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 of lab reagents 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 collagenase for laboratory use that are recognized at the time the product is shipped to customers for laboratory use.

Royalty / Mark-up on Cost of Goods Sold / Earn-Out Revenue

For those arrangements for which royalty, mark-up on cost of goods sold or earn-out payment information becomes available and collectability is reasonably assured, we recognize revenue during the applicable period earned. For interim quarterly reporting purposes, when collectability is reasonably assured but a reasonable estimate of royalty, mark-up on cost of goods sold or earn-out payment revenues cannot be made, the royalty, mark-up on cost of goods sold and earn-out payment revenues are generally recognized in the quarter that the applicable licensee provides the written report and sufficient related information to us.

Under our development and license agreement with Auxilium (as amended and restated on each of December 11, 2008 and August 31, 2011, the "Auxilium Agreement"), we do not participate in the selling, marketing or manufacturing of products for which we receive royalties and a mark-up of the cost of goods sold revenues. The royalty and mark-up on cost of goods sold revenues will generally be recognized in the quarter that Auxilium provides the written reports and related information to us, that is, royalty and mark up on cost of goods sold revenues are generally recognized one quarter following the quarter in which sales by Auxilium occurred. The royalties payable by Auxilium to us are subject to set-off for certain patent costs.

Under a March 2006 agreement (the "DFB Agreement"), pursuant to which we sold our topical collagenase business to DFB Biotech, Inc. and its affiliates ("DFB"), we have the right to receive earn-out payments in the future based on sales of certain products.  Generally, under the DFB Agreement we would receive payments and a report within ninety (90) days from the end of each calendar year after DFB has sold the royalty-bearing product. Currently, DFB is providing us earn-out reports on a quarterly basis.

License Revenue

We include revenue recognized from upfront licensing, sublicensing and milestone payments in "License Revenues" 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 U.S. Food and Drug Administration 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 consulting and technical assistance contracts primarily as a result of the DFB Agreement. Consulting revenues are recognized ratably over the term of the contract. The consulting and technical assistance obligations to DFB expired in March 2011.
Treasury Stock
The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders' equity.

Accounts receivable and Allowance for Doubtful Accounts

Trade accounts receivable are stated at the amount the Company expects to collect. We maintain allowances for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. We consider the following factors when determining the collectability of specific customer accounts: customer credit-worthiness, past transaction history with the customer, current economic industry trends, and changes in customer payment terms.  Our accounts receivable balance is typically due from its two large pharmaceutical customers.  These companies have historically paid timely and have been financially stable organizations.  Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.  If the financial condition of our customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required.  We provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after we have used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable.  We recorded no material bad debt expense in the quarter ended June 30, 2012.  The allowance for doubtful accounts balance as of June 30, 2012 and 2011 was $30,095.
Accounts receivable as of June 30, 2012 is approximately $2.8 million, which consists of approximately $1.3 million due from DFB in accordance with the earn-out under the DFB Agreement and approximately $1.5 million in royalties due from Auxilium in accordance with the terms of the Auxilium Agreement.
Reimbursable Third Party Development Costs

We accrue expenses for research and development that are reimbursable by us under the Auxilium Agreement.  We capitalize certain patent costs related to estimated third party development costs that are reimbursable under the Auxilium Agreement. In August 2011, through the amendment and restatement of our development and license agreement with Auxilium, we have clarified the rights and responsibilities of the joint development of XIAFLEX. We resolved what had been an on-going dispute with Auxilium concerning the appropriate amount of creditable third party development expenses related to the lyophilization of the injection formulation and certain patent expenses for research and development costs that were reimbursable under the Auxilium Agreement. We do not expect any additional third party development cost related to the lyophilization of the injection formulation.  Any estimates of patent costs are based on contractual terms, historical costs, reviewing third party data and expectations regarding future development for certain products.

If conditions or other circumstances change, we may take actions to revise our reimbursable third party patent cost estimates. These revisions could result in an incremental increase or decrease in research and development costs. For example, the Auxilium Agreement provides that Auxilium and BioSpecifics will share equally certain patent expenses which are creditable against future royalty revenues.

As of June 30, 2012 our net reimbursable third party patent costs accrual was approximately $74,000.

Research and Development Expenses

Research and development ("R&D") expenses include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expense, facility costs and overhead. R&D expenses also consist of third party costs, such as medical professional fees, product costs used in clinical trials, consulting fees and costs associated with clinical study 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

The Company has two stock-based compensation plans in effect. Accounting Standards Codification 718, Compensation - Stock Compensation ("ASC 718") requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based awards including stock options and common stock issued to our employees and directors under our stock plans. It requires companies to estimate the fair value of share-based awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service periods in our consolidated statements of operations.

Under the ASC 718, 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 an 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 the expected term of an award, we use the simplified method. 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 Company granted 15,000 stock options, valued at approximately $109,000, during the three month period ended June 30, 2012.  The Company used Black-Scholes valuation model to estimate the value of options using 54% volatility, a risk free rate of 0.69% and average exercise period of five years..
 
Further, ASC 718 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 ASC 718 was as follows:

 
 
Three Months Ended
June 30,
 
 
Six Months Ended
June 30,
 
 
 
2012
 
 
2011
 
 
2012
 
 
2011
 
     Research and development
 
$
122,679
 
 
$
25,457
 
 
$
144,817
 
 
$
52,573
 
     General and administrative
 
 
13,200
 
 
 
105,752
 
 
 
30,868
 
 
 
212,334
 
Total stock-based compensation expense
 
$
135,879
 
 
$
131,209
 
 
175,685
 
 
264,907
 


Stock Option Activity

A summary of our stock option activity during the six months ended June 30, 2012 is presented below:

 
 
Total Number
 
 
Weighted-Average
 
Options
 
of Shares
 
 
Exercise Price
 
Outstanding as of December 31, 2011
 
 
1,261,425
 
 
$
8.27
 
Granted
 
 
15,000
 
 
 
15.75
 
Forfeited
 
 
-
 
 
 
-
 
Exercised
 
 
24,000
 
 
 
3.25
 
Expired
 
 
-
 
 
 
-
 
Outstanding as of June 30, 2012
 
 
1,252,425
 
 
$
8.46
 

Exercisable as of June 30, 2012
 
 
 
1,172,425
$ 
7.48
 

During the six months ended June 30, 2012 and 2011, $78,000 and $72,450, respectively, were received from stock options exercised by option holders.

The aggregate intrinsic value of options outstanding and exercisable as of June 30, 2012 was approximately $13.2 million. Aggregate intrinsic value represents the total pre-tax intrinsic value, based on the closing price of our common stock of $18.78 on June 29, 2012, 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, 2012 was approximately $79,000 which we expect to recognize over a weighted-average period of nine months.

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 amortized over the lesser of their estimated useful lives or the remaining life of the lease.

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 use the asset and liability method of accounting for income taxes, as set forth in Accounting Standards Codification 740-10-25-2. Under this method, deferred income taxes, when required, are provided on the basis of the difference between the financial reporting and income tax basis of assets and liabilities at the statutory rates enacted for future periods. In accordance with Accounting Standards Codification 740-10-45-25, Income Statement Classification of Interest and Penalties, we classify interest associated with income taxes under interest expense and tax penalties under other.

Future Impact of Recently Issued Accounting Standards
In May 2011, the Financial Accounting Standards Board ("FASB") issued ASU 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and International Financial Reporting Standard ("IFRS"), to converge fair value measurement and disclosure guidance in U.S. GAAP with the guidance in the International Accounting Standards Board's concurrently issued IFRS 13, Fair Value Measurement. The amendments in ASU 2011-04 do not modify the requirements for when fair value measurements apply; rather, they generally represent clarifications on how to measure and disclose fair value under ASC 820, Fair Value Measurement. The amendments in the ASU 2011-04 are effective prospectively for interim and annual periods beginning after December 15, 2011. Early adoption is not permitted for public entities. Adoption of this standard did not have a material impact on the financial statements.
In June 2011, the FASB issued Accounting Standards Update No. 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income ("ASU 2011-05") Under ASU 2011-05, an entity is required to present comprehensive income on the income statement or as a separate financial statement. ASU 2011-05 is effective January 1, 2012. ASU 2011-05 affects financial statement presentation only and has no effect on results of operations or financial position.  We adopted this new guidance effective March 31, 2012 and chose to use the two separate but consecutive statements. presentation approach.
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SUBSEQUENT EVENTS (Details) (Subsequent Event [Member])
6 Months Ended
Jun. 30, 2012
Subsequent Event [Line Items]  
Subsequent event date Jul. 30, 2012
Number of patients enrolled for open-label phase IIIb trial by Auxilium 60
Number of sites throughout U.S. and Australia at which patients were enrolled for open-label phase IIIb trial 8
Number of cords treated concurrently in Dupuytren's surgeries, minimum 2
Minimum [Member]
 
Subsequent Event [Line Items]  
Percentage of annual Dupuytren's surgeries in the US performed to treat two or more cords concurrently 35.00%
Maximum [Member]
 
Subsequent Event [Line Items]  
Percentage of annual Dupuytren's surgeries in the US performed to treat two or more cords concurrently 40.00%
XML 16 R28.htm IDEA: XBRL DOCUMENT v2.4.0.6
RELATED PARTY TRANSACTIONS (Details) (ABC-NY [Member], USD $)
6 Months Ended
Jun. 30, 2012
ABC-NY [Member]
 
Related Party Transaction [Line Items]  
Monthly rental price $ 11,250
Termination of Lease Agreement Mar. 31, 2011
XML 17 R8.htm IDEA: XBRL DOCUMENT v2.4.0.6
ORGANIZATION AND DESCRIPTION OF BUSINESS
6 Months Ended
Jun. 30, 2012
ORGANIZATION AND DESCRIPTION OF BUSINESS [Abstract]  
ORGANIZATION AND DESCRIPTION OF BUSINESS
1. ORGANIZATION AND DESCRIPTION OF BUSINESS

We are a biopharmaceutical company involved in the development of an injectable collagenase for multiple indications. We are a party to a development and license agreement with Auxilium Pharmaceuticals, Inc. ("Auxilium") for injectable collagenase (which Auxilium has named XIAFLEX® (collagenase clostridium histolyticum)) for clinical indications in Dupuytren's contracture, Peyronie's disease and frozen shoulder (adhesive capsulitis). Auxilium has an option to acquire additional indications that we may pursue, including cellulite, for which we have granted Auxilium the right to initiate early development studies at its cost, and human and canine lipoma. Auxilium is currently selling XIAFLEX in the U.S. for the treatment of Dupuytren's contracture. Auxilium has an agreement with Pfizer, Inc. ("Pfizer") pursuant to which Pfizer has the right to market XIAFLEX for Dupuytren's contracture and Peyronie's disease in Europe and certain Eurasian countries, and will do so under the registered trademark XIAPEX® (collagenase clostridium histolyticum). Pfizer received marketing authorization for Dupuytren's contracture by the European Commission on February 28, 2011 and began sales in certain countries in the European Union in April 2011. In addition, Auxilium has an agreement with Asahi Kasei Pharma Corporation ("Asahi") pursuant to which Asahi has the right to commercialize XIAFLEX for the treatment of Duputyren's contracture and Peyronie's disease in Japan. Auxilium also has an agreement with Actelion Pharmaceuticals Ltd. ("Actelion") pursuant to which Actelion has the right to commercialize XIAFLEX for the treatment of Duputyren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico. Actelion was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada.

Pursuant to a March 2006 agreement (the "DFB Agreement") between the Company and DFB Biotech, Inc. ("DFB"), we continue to receive earn-out payments based on the sales of Santyl.  Our right to receive earn-out payments with respect to the marketed topical product sold to DFB expires in June 2013, but earn-out payments for second generation collagenase products, if any, continue indefinitely.

Operational Highlights

On May 7, 2012, we announced the initiation of a placebo controlled randomized Phase II clinical trial, Chien-804, to evaluate the efficacy of XIAFLEX for canines with benign subcutaneous lipomas. The single injection study will evaluate 32 dogs randomized 1:1 XIAFLEX to placebo. Auxilium has the option to license development and marketing rights to this canine lipoma indication.  We anticipate that we will complete enrollment by the first half of 2013.
 
In a May 9, 2012 press release, Auxilium announced that The Journal of Urology had published on its website, Auxilium's phase IIb clinical trial of XIAFLEX for the potential nonsurgical treatment of Peyronie's disease.  Top line data from this trial had been previously reported by Auxilium. The study appeared in the June 2012 print version of The Journal of Urology.

On June 4, 2012, we announced positive top-line results from the IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) Phase III clinical program of XIAFLEX for the treatment of Peyronie's disease, which was conducted by our partner Auxilium. Results from the two randomized, double-blind, placebo-controlled studies at 52 weeks demonstrated statistically significant improvements in both co-primary endpoints of the trials, including percent improvement from baseline in penile curvature deformity compared to placebo and change from baseline (improvement) in the Peyronie's disease bother domain of Auxilium's Peyronie's Disease Questionnaire ("PDQ") compared to placebo. Auxilium expects to submit a supplemental Biologics License Application ("sBLA") filing to the U.S. Food and Drug Administration ("FDA") by the end of 2012.

On June 26, 2012, we announced that we initiated a Phase II trial of XIAFLEX for the treatment of human lipoma. Human lipomas are encapsulated deposits of benign fat often detected as bulges under the skin and are diagnosed in 575,000 U.S. patients annually. We anticipate that we will complete enrollment by the first half of 2013.
In a July 9, 2012 press release, Auxilium and Actelion announced that Auxilium was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada. Under the terms of the Collaboration Agreement between Actelion and Auxilium, Actelion received exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Pursuant to the Collaboration Agreement, Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion and Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in Canada and, upon approval, in the remainder of these countries. Actelion expects to make XIAFLEX available to patients in Canada in the first half of 2013.
In a July 30, 2012 press release, Auxilium announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords.  Auxilium enrolled 60 patients at eight sites throughout the U.S. and Australia.  In the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the Company to seek FDA approval and expansion of the Dupuytren's label.  Based on research by SDI Health, LLC estimating that 35 to 40% of annual Dupuytren's surgeries in the US are performed to treat two or more cords concurrently, Auxilium is conducting these studies to seek a multicord indication for XIAFLEX from the FDA.  Auxilium expects topline results in the first half of 2014.
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Consolidated Balance Sheets (unaudited) (USD $)
Jun. 30, 2012
Dec. 31, 2011
Current assets:    
Cash and cash equivalents $ 3,788,173 $ 3,196,831
Short-term investments 5,000,000 5,000,000
Accounts receivable, net 2,820,845 3,236,917
Income tax receivable 51,070 244,720
Deferred tax assets 826,534 1,309,801
Prepaid expenses and other current assets 219,481 98,234
Total current assets 12,706,103 13,086,503
Deferred royalty buy-down 2,750,000 1,250,000
Deferred tax assets - long term 1,805,366 1,738,154
Patent costs, net 225,193 190,416
Total assets 17,486,662 16,265,073
Current liabilities:    
Accounts payable and accrued expenses 659,764 601,002
Accrued tax liability 102,471 0
Deferred revenue 253,115 437,099
Accrued liabilities of discontinued operations 78,138 78,138
Total current liabilities 1,093,488 1,116,239
Long-term deferred revenue 241,955 276,520
Stockholders' equity:    
Series A Preferred stock, $.50 par value, 700,000 shares authorized; none outstanding 0 0
Common stock, $.001 par value; 10,000,000 shares authorized ; 6,554,743 and 6,530,743 shares issued at June 30, 2012 and December 31, 2011, respectively 6,555 6,531
Additional paid-in capital 20,404,909 20,049,196
Accumulated deficit (1,882,832) (3,291,904)
Treasury stock, 223,191 and 194,604 shares at cost at June 30, 2012 and December 31, 2011, respectively (2,377,413) (1,891,509)
Total stockholders' equity 16,151,219 14,872,314
Total liabilities and stockholders' equity $ 17,486,662 $ 16,265,073
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Consolidated Statements of Cash Flows (unaudited) (USD $)
6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Cash flows from operating activities:    
Net income $ 1,409,072 $ 6,260,464
Adjustments to reconcile net income to net cash provided by (used in) operating activities:    
Depreciation and amortization 29,019 21,220
Stock-based compensation expense 175,685 264,907
Deferred tax assets 416,055 (3,103,944)
Changes in operating assets and liabilities:    
Accounts receivable 416,072 1,108,734
Prepaid expenses and other current assets 72,403 (59,477)
Accounts payable and accrued expenses 97,438 (1,889,632)
Deferred revenue (218,550) (265,219)
Net cash provided by operating activities 2,397,194 2,337,053
Cash flows from investing activities:    
Maturity of marketable investments 2,000,000 0
Purchases of marketable investments (2,000,000) 0
Payment for royalty buy down (1,500,000) 0
Net cash used in investing activities (1,500,000) 0
Cash flows from financing activities:    
Proceeds from stock option exercises 78,000 72,450
Payments for repurchase of common stock (485,904) (206,347)
Excess tax benefits from share-based payment arrangements 102,052 346,539
Net provided by (cash used) in financing activities (305,852) 212,642
Increase in cash and cash equivalents 591,342 2,549,695
Cash and cash equivalents at beginning of year 3,196,831 2,470,852
Cash and cash equivalents at end of period 3,788,173 5,020,547
Cash paid during the year for:    
Interest 0 0
Taxes $ 92,000 $ 0
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ORGANIZATION AND DESCRIPTION OF BUSINESS (Details)
6 Months Ended
Jun. 30, 2012
ORGANIZATION AND DESCRIPTION OF BUSINESS [Abstract]  
Number of European countries where XIAFLEX is selling 9
Number of dogs on which single injection study evaluate 32
Ratio of XIAFLEX to placebo 1
Number of randomized, double-blind, placebo-controlled studies of IMPRESS Phase III clinical program of XIAFLEX conducted by Auxilium 2
Period over which studies of IMPRESS Phase III clinical program of XIAFLEX were conducted by Auxilium (in weeks) 52
Number of U.S. patients diagnosed with human lipomas annually 575,000
Number of patients anticipated to participate in single center dose escalation study of Phase II trial of XIAFLEX for treatment of human lipoma 14
Subsequent Event [Member]
 
Subsequent Event [Line Items]  
Subsequent event date Jul. 30, 2012
Number of patients enrolled for open-label phase IIIb trial by Auxilium 60
Number of sites throughout U.S. and Australia at which patients were enrolled for open-label phase IIIb trial 8
Number of cords treated concurrently in Dupuytren's surgeries, minimum 2
Subsequent Event [Member] | Minimum [Member]
 
Subsequent Event [Line Items]  
Percentage of annual Dupuytren's surgeries in the US performed to treat two or more cords concurrently (in hundredths) 35.00%
Subsequent Event [Member] | Maximum [Member]
 
Subsequent Event [Line Items]  
Percentage of annual Dupuytren's surgeries in the US performed to treat two or more cords concurrently (in hundredths) 40.00%
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NET INCOME (LOSS) PER SHARE (Details)
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Number of common equivalent shares included for the calculation of diluted net income [Abstract]        
Stock options 628,331 820,433 644,328 833,856
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Consolidated Statements of Cash Flows (unaudited) (Parenthetical) (USD $)
6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Supplemental disclosures of non-cash transactions:    
Patent costs accrued from Auxilium $ 64,000 $ 14,000
Patent amortizations expenses $ 29,000 $ 21,000
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Consolidated Balance Sheets (unaudited) (Parenthetical) (USD $)
Jun. 30, 2012
Dec. 31, 2011
Stockholders' equity:    
Series A Preferred stock, par value (in dollars per share) $ 0.5 $ 0.5
Series A Preferred stock, authorized (in shares) 700,000 700,000
Series A Preferred stock, outstanding (in shares) 0 0
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, authorized (in shares) 10,000,000 10,000,000
Common stock, issued (in shares) 6,554,743 6,530,743
Treasury stock, shares (in shares) 223,191 194,604
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
6 Months Ended
Jun. 30, 2012
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
Basis of Presentation
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 U.S. generally accepted accounting principles ("U.S. GAAP") has been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the "SEC") for quarterly reporting.

The information included in this Report should be read in conjunction with our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 and our Annual Report on Form 10-K for the year ended December 31, 2011 filed with the SEC on May 10, 2012 and March 13, 2012, respectively.
Principles of Consolidation
Principles of Consolidation
The audited consolidated financial statements include the accounts of the Company and its subsidiary, ABC-NY.
Critical Accounting Policies, Estimates and Assumptions
Critical Accounting Policies, Estimates and Assumptions

The preparation of consolidated financial statements in conformity with U.S. GAAP 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 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. Actual results could differ from those estimates.
Cash, Cash Equivalents and Short-term Investments
Cash, Cash Equivalents and Short-term Investments

Cash, cash equivalents and short-term investments 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 short-term investments by placing its investments with banks it believes are highly creditworthy and with highly rated money market funds, U.S. government securities, or certificates of deposit.
Fair Value Measurements
Fair Value Measurements
 
 
 
The Fair Value Measurements and Disclosures Topic of the Accounting Standards Codification defines fair value, establishes a framework for measuring fair value in applying generally accepted accounting principles, and expands disclosures about fair value measurements. This Codification topic identifies two kinds of inputs that are used to determine the fair value of assets and liabilities: observable and unobservable. Observable inputs are based on market data or independent sources while unobservable inputs are based on our own market assumptions. Once inputs have been characterized, this Codification topic requires us to prioritize the inputs used to measure fair value into one of three broad levels. Fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values identified by Level 2 inputs utilize observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities. Fair values identified by Level 3 inputs are unobservable data points and are used to measure fair value to the extent that observable inputs are not available. Unobservable inputs reflect our own assumptions about the assumptions that market participants would use in pricing the asset or liability.
Revenue Recognition
Revenue Recognition

We currently recognize revenues resulting from product sales, the licensing and sublicensing of the use of our technology and from services we sometimes perform in connection with the licensed technology under the guidance of Accounting Standards Codification 605, Revenue Recognition ("ASC 605").

If we determine that separate elements exist in a revenue arrangement under ASC 605, 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 of lab reagents 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 collagenase for laboratory use that are recognized at the time the product is shipped to customers for laboratory use.

Royalty / Mark-up on Cost of Goods Sold / Earn-Out Revenue

For those arrangements for which royalty, mark-up on cost of goods sold or earn-out payment information becomes available and collectability is reasonably assured, we recognize revenue during the applicable period earned. For interim quarterly reporting purposes, when collectability is reasonably assured but a reasonable estimate of royalty, mark-up on cost of goods sold or earn-out payment revenues cannot be made, the royalty, mark-up on cost of goods sold and earn-out payment revenues are generally recognized in the quarter that the applicable licensee provides the written report and sufficient related information to us.

Under our development and license agreement with Auxilium (as amended and restated on each of December 11, 2008 and August 31, 2011, the "Auxilium Agreement"), we do not participate in the selling, marketing or manufacturing of products for which we receive royalties and a mark-up of the cost of goods sold revenues. The royalty and mark-up on cost of goods sold revenues will generally be recognized in the quarter that Auxilium provides the written reports and related information to us, that is, royalty and mark up on cost of goods sold revenues are generally recognized one quarter following the quarter in which sales by Auxilium occurred. The royalties payable by Auxilium to us are subject to set-off for certain patent costs.

Under a March 2006 agreement (the "DFB Agreement"), pursuant to which we sold our topical collagenase business to DFB Biotech, Inc. and its affiliates ("DFB"), we have the right to receive earn-out payments in the future based on sales of certain products.  Generally, under the DFB Agreement we would receive payments and a report within ninety (90) days from the end of each calendar year after DFB has sold the royalty-bearing product. Currently, DFB is providing us earn-out reports on a quarterly basis.

License Revenue

We include revenue recognized from upfront licensing, sublicensing and milestone payments in "License Revenues" 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 U.S. Food and Drug Administration 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 consulting and technical assistance contracts primarily as a result of the DFB Agreement. Consulting revenues are recognized ratably over the term of the contract. The consulting and technical assistance obligations to DFB expired in March 2011.
Treasury Stock
Treasury Stock
The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders' equity.
Accounts receivable and Allowance for Doubtful Accounts
Accounts receivable and Allowance for Doubtful Accounts

Trade accounts receivable are stated at the amount the Company expects to collect. We maintain allowances for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. We consider the following factors when determining the collectability of specific customer accounts: customer credit-worthiness, past transaction history with the customer, current economic industry trends, and changes in customer payment terms.  Our accounts receivable balance is typically due from its two large pharmaceutical customers.  These companies have historically paid timely and have been financially stable organizations.  Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.  If the financial condition of our customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required.  We provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after we have used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable.  We recorded no material bad debt expense in the quarter ended June 30, 2012.  The allowance for doubtful accounts balance as of June 30, 2012 and 2011 was $30,095.
Accounts receivable as of June 30, 2012 is approximately $2.8 million, which consists of approximately $1.3 million due from DFB in accordance with the earn-out under the DFB Agreement and approximately $1.5 million in royalties due from Auxilium in accordance with the terms of the Auxilium Agreement.
Reimbursable Third Party Development Costs
Reimbursable Third Party Development Costs

We accrue expenses for research and development that are reimbursable by us under the Auxilium Agreement.  We capitalize certain patent costs related to estimated third party development costs that are reimbursable under the Auxilium Agreement. In August 2011, through the amendment and restatement of our development and license agreement with Auxilium, we have clarified the rights and responsibilities of the joint development of XIAFLEX. We resolved what had been an on-going dispute with Auxilium concerning the appropriate amount of creditable third party development expenses related to the lyophilization of the injection formulation and certain patent expenses for research and development costs that were reimbursable under the Auxilium Agreement. We do not expect any additional third party development cost related to the lyophilization of the injection formulation.  Any estimates of patent costs are based on contractual terms, historical costs, reviewing third party data and expectations regarding future development for certain products.

If conditions or other circumstances change, we may take actions to revise our reimbursable third party patent cost estimates. These revisions could result in an incremental increase or decrease in research and development costs. For example, the Auxilium Agreement provides that Auxilium and BioSpecifics will share equally certain patent expenses which are creditable against future royalty revenues.

As of June 30, 2012 our net reimbursable third party patent costs accrual was approximately $74,000.
Research and Development Expenses
Research and Development Expenses

Research and development ("R&D") expenses include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expense, facility costs and overhead. R&D expenses also consist of third party costs, such as medical professional fees, product costs used in clinical trials, consulting fees and costs associated with clinical study 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
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
Stock-Based Compensation

The Company has two stock-based compensation plans in effect. Accounting Standards Codification 718, Compensation - Stock Compensation ("ASC 718") requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based awards including stock options and common stock issued to our employees and directors under our stock plans. It requires companies to estimate the fair value of share-based awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service periods in our consolidated statements of operations.

Under the ASC 718, 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 an 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 the expected term of an award, we use the simplified method. 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 Company granted 15,000 stock options, valued at approximately $109,000, during the three month period ended June 30, 2012.  The Company used Black-Scholes valuation model to estimate the value of options using 54% volatility, a risk free rate of 0.69% and average exercise period of five years..
 
Further, ASC 718 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.
Property, Plant and Equipment
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 amortized over the lesser of their estimated useful lives or the remaining life of the lease.
Income Taxes
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 use the asset and liability method of accounting for income taxes, as set forth in Accounting Standards Codification 740-10-25-2. Under this method, deferred income taxes, when required, are provided on the basis of the difference between the financial reporting and income tax basis of assets and liabilities at the statutory rates enacted for future periods. In accordance with Accounting Standards Codification 740-10-45-25, Income Statement Classification of Interest and Penalties, we classify interest associated with income taxes under interest expense and tax penalties under other.
Future Impact of Recently Issued Accounting Standards
Future Impact of Recently Issued Accounting Standards
In May 2011, the Financial Accounting Standards Board ("FASB") issued ASU 2011-04, Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and International Financial Reporting Standard ("IFRS"), to converge fair value measurement and disclosure guidance in U.S. GAAP with the guidance in the International Accounting Standards Board's concurrently issued IFRS 13, Fair Value Measurement. The amendments in ASU 2011-04 do not modify the requirements for when fair value measurements apply; rather, they generally represent clarifications on how to measure and disclose fair value under ASC 820, Fair Value Measurement. The amendments in the ASU 2011-04 are effective prospectively for interim and annual periods beginning after December 15, 2011. Early adoption is not permitted for public entities. Adoption of this standard did not have a material impact on the financial statements.
In June 2011, the FASB issued Accounting Standards Update No. 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income ("ASU 2011-05") Under ASU 2011-05, an entity is required to present comprehensive income on the income statement or as a separate financial statement. ASU 2011-05 is effective January 1, 2012. ASU 2011-05 affects financial statement presentation only and has no effect on results of operations or financial position.  We adopted this new guidance effective March 31, 2012 and chose to use the two separate but consecutive statements. presentation approach.
XML 26 R1.htm IDEA: XBRL DOCUMENT v2.4.0.6
Document and Entity Information
6 Months Ended
Jun. 30, 2012
Aug. 06, 2012
Document and Entity Information [Abstract]    
Entity Registrant Name BIOSPECIFICS TECHNOLOGIES CORP  
Entity Central Index Key 0000875622  
Current Fiscal Year End Date --12-31  
Entity Well-known Seasoned Issuer No  
Entity Voluntary Filers No  
Entity Current Reporting Status Yes  
Entity Filer Category Accelerated Filer  
Entity Common Stock, Shares Outstanding   6,332,452
Document Fiscal Year Focus 2012  
Document Fiscal Period Focus Q2  
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Jun. 30, 2012  
XML 27 R18.htm IDEA: XBRL DOCUMENT v2.4.0.6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
6 Months Ended
Jun. 30, 2012
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
Assets and liabilities measured at fair value on a recurring basis
The following table presents information about our assets and liabilities that are measured at fair value on a recurring basis for the period presented and indicates the fair value hierarchy of the valuation techniques we utilized to determine such fair value.
 
 
 
 
June 30, 2012
 
Fair Value
 
 
Quoted Prices in
Active Markets for
Identical Assets
Level 1
 
 
Significant
Other Observable
Inputs
Level 2
 
Significant
Unobservable
Inputs
Level 3
Cash and cash equivalents
 
3,788,173
 
 
$
3,788,173
 
 
 
-
 
  
 
-
Certificates of Deposit
 
 
5,000,000
 
 
 
5,000,000
 
 
 
-
 
  
 
-
Stock-based compensation expense
Stock-based compensation expense recognized under ASC 718 was as follows:

 
 
Three Months Ended
June 30,
 
 
Six Months Ended
June 30,
 
 
 
2012
 
 
2011
 
 
2012
 
 
2011
 
     Research and development
 
$
122,679
 
 
$
25,457
 
 
$
144,817
 
 
$
52,573
 
     General and administrative
 
 
13,200
 
 
 
105,752
 
 
 
30,868
 
 
 
212,334
 
Total stock-based compensation expense
 
$
135,879
 
 
$
131,209
 
 
175,685
 
 
264,907
 
Summary of stock option activity
A summary of our stock option activity during the six months ended June 30, 2012 is presented below:

 
 
Total Number
 
 
Weighted-Average
 
Options
 
of Shares
 
 
Exercise Price
 
Outstanding as of December 31, 2011
 
 
1,261,425
 
 
$
8.27
 
Granted
 
 
15,000
 
 
 
15.75
 
Forfeited
 
 
-
 
 
 
-
 
Exercised
 
 
24,000
 
 
 
3.25
 
Expired
 
 
-
 
 
 
-
 
Outstanding as of June 30, 2012
 
 
1,252,425
 
 
$
8.46
 

Exercisable as of June 30, 2012
 
 
 
1,172,425
$ 
7.48
 
XML 28 R4.htm IDEA: XBRL DOCUMENT v2.4.0.6
Consolidated Statements of Operations (unaudited) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Revenues:        
Net sales $ 1,246 $ 5,882 $ 8,750 $ 11,774
Royalties 2,491,313 1,706,166 4,391,282 2,651,247
Licensing revenues 109,275 3,296,776 788,550 4,156,051
Consulting fees 0 0 0 46,667
Total Revenues 2,601,834 5,008,824 5,188,582 6,865,739
Costs and expenses:        
Research and development 404,346 270,799 653,898 482,865
General and administrative 1,149,926 1,418,016 2,238,648 2,927,542
Total Cost and Expenses 1,554,272 1,688,815 2,892,546 3,410,407
Operating income 1,047,562 3,320,009 2,296,036 3,455,332
Other income (expense):        
Interest income 9,771 16,688 19,264 33,248
Other income (expense) 0 14,479 0 14,479
Total other income (expense) 9,771 31,167 19,264 47,727
Income before expense for income tax 1,057,333 3,351,176 2,315,300 3,503,059
Income tax benefit (expense) (390,651) (781,835) (906,228) 2,757,405
Net income $ 666,682 $ 2,569,341 $ 1,409,072 $ 6,260,464
Basic net income per share (in dollars per share) $ 0.11 $ 0.40 $ 0.22 $ 0.99
Diluted net income per share (in dollars per share) $ 0.10 $ 0.36 $ 0.20 $ 0.87
Shares used in computation of basic net income per share (in shares) 6,343,356 6,354,135 6,339,930 6,324,168
Shares used in computation of diluted net income per share (in shares) 6,971,687 7,174,568 6,984,258 7,158,024
XML 29 R12.htm IDEA: XBRL DOCUMENT v2.4.0.6
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
6 Months Ended
Jun. 30, 2012
ACCOUNTS PAYABLE AND ACCRUED EXPENSES [Abstract]  
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
5. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consisted of the following:

 
 
June 30,
  
December 31,
 
 
 
2012
  
2011
 
Trade accounts payable and accrued expenses
 
$
448,362
  
$
407,954
 
Accrued legal and other professional fees
  
64,379
   
50,000
 
Accrued payroll and related costs
  
147,023
   
143,048
 

        Total
 
 
$
659,764
 
 
 
$
601,002
 
 
XML 30 R11.htm IDEA: XBRL DOCUMENT v2.4.0.6
COMPREHENSIVE INCOME (LOSS)
6 Months Ended
Jun. 30, 2012
COMPREHENSIVE INCOME (LOSS) [Abstract]  
COMPREHENSIVE INCOME (LOSS)
4. COMPREHENSIVE INCOME (LOSS)

For the three and six months ended June 30, 2012 and 2011, we had no components of other comprehensive income or loss other than net income itself.
XML 31 R23.htm IDEA: XBRL DOCUMENT v2.4.0.6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Dec. 31, 2011
Royalty / Mark-up on Cost of Goods Sold / Earn-Out Revenue [Abstract]          
Number of quarters after which revenue is recognized (in quarters)     1    
Number of days after calendar year, after which payments and report are received (in days)     90 days    
Accounts receivable and Allowance for Doubtful Accounts [Abstract]          
Number of major customers     2    
Allowance for doubtful accounts $ 30,095 $ 30,095 $ 30,095 $ 30,095  
Accounts receivable 2,820,845   2,820,845   3,236,917
Reimbursable Third Party Development Costs [Abstract]          
Accrued patent costs 74,000   74,000    
Stock-Based Compensation [Abstract]          
Number of stock-based compensation plans in effect     2    
Value of stock options granted 109,000        
Fair value assumptions used to estimate the value options [Abstract]          
Volatility (in hundredths)     54.00%    
Risk free rate (in hundredths)     0.69%    
Average exercise period     5 years    
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]          
Stock-based compensation expense 135,879 131,209 175,685 264,907  
Total Number of Shares          
Options Outstanding, beginning of period (in shares)     1,261,425    
Granted (in shares)     15,000    
Forfeited (in shares)     0    
Exercised (in shares)     24,000    
Expired (in shares)     0    
Options Outstanding, end of period (in shares) 1,252,425   1,252,425    
Exercisable, end of period (in shares) 1,172,425   1,172,425    
Weighted Average Exercise Price          
Options Outstanding, beginning of period (in dollars per share)     $ 8.27    
Granted (in dollars per share)     $ 15.75    
Forfeited (in dollars per share)     $ 0    
Exercised (in dollars per share)     $ 3.25    
Expired (in dollars per share)     $ 0    
Options Outstanding, end of period (in dollars per share) $ 8.46   $ 8.46    
Exercisable, end of period (in dollars per share) $ 7.48   $ 7.48    
Proceeds from stock option exercises     78,000 72,450  
Aggregate intrinsic value of options outstanding and exercisable 13,200,000   13,200,000    
Closing price of common stock (in dollars per share) $ 18.78   $ 18.78    
Unrecognized compensation cost related to non-vested stock options outstanding 79,000   79,000    
Weighted-average period over which unrecognized compensation cost to be recognized     9 months    
Minimum [Member]
         
Property, Plant and Equipment [Line Items]          
Estimated useful life of property, plant and equipment (in years)     5 years    
Maximum [Member]
         
Property, Plant and Equipment [Line Items]          
Estimated useful life of property, plant and equipment (in years)     10 years    
Research and development [Member]
         
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]          
Stock-based compensation expense 122,679 25,457 144,817 52,573  
General and administrative [Member]
         
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]          
Stock-based compensation expense 13,200 105,752 30,868 212,334  
DFB Biotech Inc [Member]
         
Accounts receivable and Allowance for Doubtful Accounts [Abstract]          
Accounts receivable 1,300,000   1,300,000    
Auxilium [Member]
         
Accounts receivable and Allowance for Doubtful Accounts [Abstract]          
Accounts receivable 1,500,000   1,500,000    
Recurring [Member] | Cash and Cash Equivalents [Member]
         
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]          
Fair Value 3,788,173   3,788,173    
Recurring [Member] | Cash and Cash Equivalents [Member] | Fair Value, Inputs, Level 1 [Member]
         
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]          
Fair Value 3,788,173   3,788,173    
Recurring [Member] | Cash and Cash Equivalents [Member] | Fair Value, Inputs, Level 2 [Member]
         
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]          
Fair Value 0   0    
Recurring [Member] | Cash and Cash Equivalents [Member] | Fair Value, Inputs, Level 3 [Member]
         
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]          
Fair Value 0   0    
Recurring [Member] | Certificates of Deposit [Member]
         
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]          
Fair Value 5,000,000   5,000,000    
Recurring [Member] | Certificates of Deposit [Member] | Fair Value, Inputs, Level 1 [Member]
         
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]          
Fair Value 5,000,000   5,000,000    
Recurring [Member] | Certificates of Deposit [Member] | Fair Value, Inputs, Level 2 [Member]
         
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]          
Fair Value 0   0    
Recurring [Member] | Certificates of Deposit [Member] | Fair Value, Inputs, Level 3 [Member]
         
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]          
Fair Value $ 0   $ 0    
XML 32 R19.htm IDEA: XBRL DOCUMENT v2.4.0.6
NET INCOME (LOSS) PER SHARE (Tables)
6 Months Ended
Jun. 30, 2012
NET INCOME (LOSS) PER SHARE [Abstract]  
Number of common equivalent shares included for the calculation of diluted net income
The following table summarizes the number of common equivalent shares that were included for the calculation of diluted net income purposes from continuing operations reported in the consolidated statement of operations.
 
 
Three Months Ended
June 30,
 
 
Six Months Ended
June 30,
 
 
 
2012
 
 
2011
 
 
2012
 
 
2011
 
Stock options
 
 
628,331
 
 
 
820,433
 
 
 
644,328
 
 
 
833,856
 
XML 33 R15.htm IDEA: XBRL DOCUMENT v2.4.0.6
RELATED PARTY TRANSACTIONS
6 Months Ended
Jun. 30, 2012
RELATED PARTY TRANSACTIONS [Abstract]  
RELATED PARTY TRANSACTIONS
8. RELATED PARTY TRANSACTIONS

Our subsidiary, ABC-NY (together with the Company, the "Tenant") and Wilbur St. Corp. (the "Landlord") were parties to a lease agreement initially dated as of January 30, 1998 and modified as of June 24, 2009 (the "Lease Agreement"), pursuant to which the Landlord leased to the Tenant the premises located at 35 Wilbur Street, Lynbrook, NY 11563 (the "Premises") until June 30, 2010 and for a monthly rental price of $11,250 plus utilities and real estate taxes.  Following the expiration of the Lease Agreement, the Tenant has continued to lease the Premises from the Landlord on a month-to-month basis.  We notified the Landlord of our termination of the Lease Agreement effective March 31, 2011, but continue to hold over in the Premises. We are currently evaluating our options with respect to remaining in or leaving the Premises.  Until that evaluation is complete, we will continue to hold over in the Premises on a month-to-month basis.
XML 34 R13.htm IDEA: XBRL DOCUMENT v2.4.0.6
PATENT COSTS
6 Months Ended
Jun. 30, 2012
PATENT COSTS [Abstract]  
PATENT COSTS
6. PATENT COSTS

We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, ranging from 1 to 8 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, 2012, the Company capitalized certain patent costs, paid by Auxilium on behalf of the Company. These costs are reimbursable to Auxilium under the Auxilium Agreement and are creditable against future royalty revenues. Our net patent costs consisted of:

 
 
June 30,
 
 
December 31,
 
 
 
2012
 
 
2011
 
Patents
 
$
382,076
 
 
$
318,280
 
Accumulated Amortization
 
 
(156,883
)
 
 
(127,863
)
 
 
$
225,193
 
 
$
190,417
 

The amortization expense for patents for six months ended June 30, 2012 was approximately $29,000. In the comparable period of 2011, the amortization expense for patents was approximately $21,000. The estimated aggregate amortization expense for each of the next five years is approximately as follows:

2013
52,000
2014
42,000
2015
17,000
2016
14,000
2017 through 2020
14,000
XML 35 R14.htm IDEA: XBRL DOCUMENT v2.4.0.6
INCOME TAXES
6 Months Ended
Jun. 30, 2012
INCOME TAXES [Abstract]  
INCOME TAXES
7. INCOME TAXES

The significant components of the Company's deferred tax assets, pursuant to Accounting Standards Codification 740-10-50 consist of net operating losses, orphan tax credits, stock-based compensation and deferred revenues. For the six month period ended June 30, 2012 net income tax expense was $0.9 million, primarily a non-cash charge.  For the six month period ended June 30, 2012, the valuation allowance with respect to the company's net deferred tax assets remained unchanged.  Our remaining deferred tax assets decreased by $0.4 million to approximately $2.6 million, primarily because we used our Orphan Drug Tax Credit to reduce our taxes payable, during six months ended June 30, 2012.
 
For the six month period ended June 30, 2011, the valuation allowance reversed by approximately $4.2 million with respect to our net deferred tax assets. We determined that it was more likely than not that these deferred tax assets would be realized based on our projected annual profitability of operations driven by our revenues under the Auxilium Agreement. The remaining balance of deferred tax assets as of June 30, 2011 was approximately $3.1 million.
XML 36 R16.htm IDEA: XBRL DOCUMENT v2.4.0.6
SUBSEQUENT EVENTS
6 Months Ended
Jun. 30, 2012
SUBSEQUENT EVENTS [Abstract]  
SUBSEQUENT EVENTS
9. SUBSEQUENT EVENTS
In a July 9, 2012 press release, Auxilium and Actelion announced that Auxilium was granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada. Under the terms of the Collaboration Agreement between Actelion and Auxilium, Actelion received exclusive rights to commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico upon receipt of the respective regulatory approvals. Pursuant to the Collaboration Agreement, Auxilium intends to transfer regulatory sponsorship of the dossier to Actelion and Actelion will be primarily responsible for the applicable regulatory and commercialization activities for XIAFLEX in Canada and, upon approval, in the remainder of these countries. Actelion expects to make XIAFLEX available to patients in Canada in the first half of 2013.
In a July 30, 2012 press release, Auxilium announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords.  Auxilium enrolled 60 patients at eight sites throughout the U.S. and Australia.  In the third quarter of 2012, Auxilium expects to begin a larger study with XIAFLEX for the concurrent treatment of multiple palpable cords that, if successful, may allow the Company to seek FDA approval and expansion of the Dupuytren's label.  Based on research by SDI Health, LLC estimating that 35 to 40% of annual Dupuytren's surgeries in the U.S. are performed to treat two or more cords concurrently, Auxilium is conducting these studies to seek a multicord indication for XIAFLEX from the FDA.  Auxilium expects topline results in the first half of 2014.
We have evaluated subsequent events for recognition or disclosure through the time of filing these consolidated financial statements on Form 10-Q with the U.S. Securities and Exchange Commission on August 9, 2012.
XML 37 R21.htm IDEA: XBRL DOCUMENT v2.4.0.6
PATENT COSTS (Tables)
6 Months Ended
Jun. 30, 2012
PATENT COSTS [Abstract]  
Net patent costs
As of June 30, 2012, the Company capitalized certain patent costs, paid by Auxilium on behalf of the Company. These costs are reimbursable to Auxilium under the Auxilium Agreement and are creditable against future royalty revenues. Our net patent costs consisted of:

 
 
June 30,
 
 
December 31,
 
 
 
2012
 
 
2011
 
Patents
 
$
382,076
 
 
$
318,280
 
Accumulated Amortization
 
 
(156,883
)
 
 
(127,863
)
 
 
$
225,193
 
 
$
190,417
 
Estimated amortization expense
The amortization expense for patents for six months ended June 30, 2012 was approximately $29,000. In the comparable period of 2011, the amortization expense for patents was approximately $21,000. The estimated aggregate amortization expense for each of the next five years is approximately as follows:

2013
52,000
2014
42,000
2015
17,000
2016
14,000
2017 through 2020
14,000
XML 38 R26.htm IDEA: XBRL DOCUMENT v2.4.0.6
PATENT COSTS (Details) (USD $)
6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Dec. 31, 2011
Net patent costs [Abstract]      
Net patent costs $ 225,193   $ 190,416
Amortization expense for patents 29,000 21,000  
Estimated amortization expense [Abstract]      
2013 52,000    
2014 42,000    
2015 17,000    
2016 14,000    
2017 through 2020 14,000    
Patents [Member]
     
Net patent costs [Abstract]      
Patents 382,076   318,280
Accumulated Amortization (156,883)   (127,863)
Net patent costs $ 225,193   $ 190,417
Patents [Member] | Minimum [Member]
     
Finite-Lived Intangible Assets [Line Items]      
Estimated useful lives 1 year    
Patents [Member] | Maximum [Member]
     
Finite-Lived Intangible Assets [Line Items]      
Estimated useful lives 8 years    
XML 39 R5.htm IDEA: XBRL DOCUMENT v2.4.0.6
Consolidated Statements of Comprehensive Income (unaudited) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
Consolidated Statements of Comprehensive Income (unaudited) [Abstract]        
Net income $ 666,682 $ 2,569,341 $ 1,409,072 $ 6,260,464
Other comprehensive income (loss) 0 0 0 0
Comprehensive income $ 666,682 $ 2,569,341 $ 1,409,072 $ 6,260,464
XML 40 R10.htm IDEA: XBRL DOCUMENT v2.4.0.6
NET INCOME (LOSS) PER SHARE
6 Months Ended
Jun. 30, 2012
NET INCOME (LOSS) PER SHARE [Abstract]  
NET INCOME (LOSS) PER SHARE
3. NET INCOME (LOSS) PER SHARE

In accordance with Accounting Standards Codification 260, Earnings Per Share, basic net income (loss) per share amount is computed using the weighted-average number of shares of common stock outstanding during the periods presented, while diluted net income (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.

The following table summarizes the number of common equivalent shares that were included for the calculation of diluted net income purposes from continuing operations reported in the consolidated statement of operations.
 
 
Three Months Ended
June 30,
 
 
Six Months Ended
June 30,
 
 
 
2012
 
 
2011
 
 
2012
 
 
2011
 
Stock options
 
 
628,331
 
 
 
820,433
 
 
 
644,328
 
 
 
833,856
 
XML 41 R27.htm IDEA: XBRL DOCUMENT v2.4.0.6
INCOME TAXES (Details) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2012
Jun. 30, 2011
Jun. 30, 2012
Jun. 30, 2011
INCOME TAXES [Abstract]        
Net income tax expense $ 390,651 $ 781,835 $ 906,228 $ (2,757,405)
Decrease in deferred tax assets     416,055 (3,103,944)
Deferred revenue recognized     2,600,000  
Reversal in valuation allowance reserve       4,200,000
Deferred tax assets   $ 3,100,000   $ 3,100,000
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ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables)
6 Months Ended
Jun. 30, 2012
ACCOUNTS PAYABLE AND ACCRUED EXPENSES [Abstract]  
Accounts payable and accrued expenses
Accounts payable and accrued expenses consisted of the following:

 
 
June 30,
  
December 31,
 
 
 
2012
  
2011
 
Trade accounts payable and accrued expenses
 
$
448,362
  
$
407,954
 
Accrued legal and other professional fees
  
64,379
   
50,000
 
Accrued payroll and related costs
  
147,023
   
143,048
 

        Total
 
 
$
659,764
 
 
 
$
601,002