0001140361-14-019846.txt : 20140509 0001140361-14-019846.hdr.sgml : 20140509 20140509144549 ACCESSION NUMBER: 0001140361-14-019846 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 9 CONFORMED PERIOD OF REPORT: 20140331 FILED AS OF DATE: 20140509 DATE AS OF CHANGE: 20140509 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: 14828527 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 10-Q 3-31-2014
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 March 31, 2014

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
 
(I.R.S. Employer
 of Incorporation or Organization)   Identification No.)
 
35 Wilbur Street Lynbrook, NY 11563
 (Address of Principal Executive Offices) (Zip Code)

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

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

Yes x No o

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

Large accelerated filer o
Accelerated filer                   x
Non-accelerated filer   o (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 May 6, 2014
Common Stock ($.001 par value)
6,395,312
 
BIOSPECIFICS TECHNOLOGIES CORP.

TABLE OF CONTENTS

 
PART II – OTHER INFORMATION
 
ITEM 1.
20
ITEM 1A.
20
ITEM 2.
20
ITEM 3.
20
ITEM 4.
21
ITEM 5.
21
ITEM 6.
21
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 – Bingham to Update

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, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, expected revenue growth, and the assumptions underlying or relating to such statements, are “forward-looking statements”. The forward-looking statements in this Report include statements concerning, among other things, the size of the market for Peyronie’s disease; and the projected receipt of payments from Auxilium. 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 timing of regulatory filings and action; the ability of BioSpecifics’ partner, Auxilium Pharmaceuticals, Inc., and its partners, Asahi Kasei Pharma Corporation, Actelion Pharmaceuticals Ltd. and Swedish Orphan Biovitrum AB, to achieve their objectives for XIAFLEX in their applicable territories; the market for XIAFLEX in, and timing, initiation and outcome of clinical trials for, additional indications including frozen shoulder, cellulite, human lipoma and canine lipoma and uterine fibroids, all of which will determine the amount of milestone, royalty, mark-up on cost of goods sold and sublicense income BioSpecifics may receive; the potential of CCH to be used in additional indications; and other risk factors identified in BioSpecifics’ Annual Report on Form 10-K for the year ended December 31, 2013, 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 we assume no obligation to update these forward-looking statements.
PART I – FINANCIAL INFORMATION

Item 1: Consolidated Financial Statements

BioSpecifics Technologies Corp.
Consolidated Balance Sheets

 
  
March 31,
    
December 31,
  
 
  
2014
    
2013
  
 
  
(unaudited)
    
(audited)
  
Assets
  
   
 
Current assets:
  
   
 
Cash and cash equivalents
  
$
8,934,794
    
$
5,624,860
  
Short-term investments
    
7,973,002
      
6,966,964
  
Accounts receivable, net
    
1,921,810
      
5,004,418
  
Income tax receivable
    
293,976
      
255,708
  
Deferred tax assets
    
97,537
      
94,992
  
Prepaid expenses and other current assets
    
327,947
      
326,519
  
Total current assets
    
19,549,066
      
18,273,461
  
 
                
Deferred royalty buy-down
    
3,350,000
      
3,350,000
  
Deferred tax assets - long term
    
1,405,219
      
1,412,784
  
Patent costs, net
    
322,607
      
215,999
  
 
                
Total assets
    
24,626,892
      
23,252,244
  
 
                
Liabilities and Stockholders' Equity
                
Current liabilities:
                
Accounts payable and accrued expenses
    
877,084
      
634,277
  
Deferred revenue
    
69,130
      
69,130
  
Accrued liabilities of discontinued operations
    
78,138
      
78,138
  
Total current liabilities
    
1,024,352
      
781,545
  
 
                
Long-term deferred revenue
    
120,978
      
138,260
  
 
                
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 ; 6,706,167 and 6,655,168 shares issued at March 31, 2014 and December 31, 2013, respectively
    
6,706
      
6,655
  
Additional paid-in capital
    
21,427,849
      
20,951,796
  
Retained earnings
    
5,729,008
      
4,975,018
  
Treasury stock, 303,964 and 300,739 shares at cost at March 31, 2014 and December 31, 2013, respectively
    
(3,682,001
)
    
(3,601,030
)
Total stockholders' equity
    
23,481,562
      
22,332,439
  
 
                
Total liabilities and stockholders’ equity
  
$
24,626,892
    
$
23,252,244
  

See accompanying notes to consolidated financial statements
BioSpecifics Technologies Corp.
Consolidated Statements of Operations
(unaudited)

 
  
Three Months Ended
March 31,
  
 
  
2014
    
2013
  
Revenues:
  
   
 
Net sales
  
$
3,678
    
$
2,243
  
Royalties
    
2,740,318
      
3,432,900
  
Licensing revenues
    
17,283
      
544,881
  
Total Revenues
    
2,761,279
      
3,980,024
  
 
                
Costs and expenses:
                
Research and development
    
382,704
      
294,874
  
General and administrative
    
1,246,305
      
1,618,482
  
Total Cost and Expenses
    
1,629,009
      
1,913,356
  
 
                
Operating income
    
1,132,270
      
2,066,668
  
 
                
Other income (expense):
                
Interest income
    
6,971
      
5,866
  
Other income
    
1,150
      
-
  
 
    
8,121
      
5,866
  
 
                
Income before expense for income tax
    
1,140,391
      
2,072,534
  
Income tax benefit (expense)
    
(386,402
)
    
(719,450
)
 
                
Net income
  
$
753,989
    
$
1,353,084
  
 
                
 
                
Basic net income per share
  
$
0.12
    
$
0.21
  
Diluted net income per share
  
$
0.11
    
$
0.19
  
 
                
Shares used in computation of basic net income per share
    
6,378,859
      
6,356,954
  
Shares used in computation of diluted net income per share
    
7,022,172
      
6,955,452
  

Consolidated Statements of Comprehensive Income

(unaudited)

 
  
Three Months Ended
March 31,
  
 
  
2014
    
2013
  
Net income
  
$
753,989
    
$
1,353,084
  
Other comprehensive income (loss)
    
-
      
-
  
Comprehensive income
  
$
753,989
    
$
1,353,084
  

See accompanying notes to consolidated financial statements
BioSpecifics Technologies Corp.
Consolidated Statements of Cash Flows
(unaudited)

 
  
Three Months Ended
March 31,
  
Cash flows from operating activities:
  
2014
    
2013
  
Net income
  
$
753,989
    
$
1,353,084
  
Adjustments to reconcile net income to net cash provided By operating activities:
                
Depreciation and amortization
    
44,845
      
16,081
  
Stock-based compensation expense
    
5,354
      
26,400
  
Deferred tax assets
    
5,020
      
18,831
  
Gain on the sale of fixed assets
    
(1,150
)
    
-
  
Changes in operating assets and liabilities:
                
Accounts receivable
    
3,082,608
      
2,172,214
  
Prepaid expenses and other current assets
    
(39,696
)
    
(214,129
)
Accounts payable and accrued expenses
    
91,356
      
253,070
  
Accrued taxes payable
    
-
      
332,924
  
Deferred revenue
    
(17,283
)
    
(44,881
)
Net cash provided by operating activities
    
3,925,043
      
3,913,594
  
 
                
Cash flows from investing activities:
                
Maturity of marketable investments
    
2,206,964
      
3,200,000
  
Purchases of marketable investments
    
(3,213,002
)
    
(3,042,964
)
Proceeds from sale of fixed asset
    
1,150
      
-
  
Net cash provided by (used in) investing activities
    
(1,004,888
)
    
157,036
  
 
                
Cash flows from financing activities:
                
Proceeds from stock option exercises
    
66,100
      
-
  
Payments for repurchase of common stock
    
(80,971
)
    
(205,949
)
Excess tax benefits from share-based payment arrangements
    
404,650
          
Net cash used in in financing activities
    
389,779
      
(205,949
)
 
                
Increase in cash and cash equivalents
    
3,309,934
      
3,864,681
  
Cash and cash equivalents at beginning of year
    
5,624,860
      
3,383,737
  
Cash and cash equivalents at end of period
  
$
8,934,794
    
$
7,248,418
  
 
                
Supplemental disclosures of cash flow information:
                
Cash paid during the year for:
                
Interest
  
$
-
    
$
-
  
Taxes
  
$
15,000
    
$
378,500
  

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 three month period ended March 31, 2014, we accrued approximately $151,000 related to certain patent costs of which we amortized approximately $45,000 in the 2014 period. For the three months ended March 31, 2013, we accrued approximately $10,000 related to these costs of which approximately $16,000 was amortized in the 2013 period.

See accompanying notes to consolidated financial statements
BIOSPECIFICS TECHNOLOGIES CORP.
 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2014
(Unaudited)

1. ORGANIZATION AND DESCRIPTION OF BUSINESS

We are a biopharmaceutical company involved in the development of an injectable collagenase for multiple indications. We have a development and license agreement with Auxilium Pharmaceuticals, Inc. (“Auxilium”) for injectable collagenase (which Auxilium has named XIAFLEX®) for marketed indications and collagenase clostridium histolyticum (“CCH”) for indications in development. Auxilium has an option to acquire additional indications that we may pursue, including human and canine lipoma. Auxilium is currently selling XIAFLEX in the U.S. for the treatment of Dupuytren’s contracture and Peyronie’s disease. Following the termination of the agreement between Auxilium and Pfizer, Inc. (“Pfizer”),  Auxilium entered into an agreement with Swedish Orphan Biovitrum AB (“Sobi”) pursuant to which Sobi has marketing rights for XIAPEX® (the EU trade name for collagenase clostridium histolyticum) for Dupuytren’s contracture and Peyronie’s disease in Europe and certain Eurasian countries. Sobi is currently selling XIAPEX in Europe for the treatment of Dupuytren’s contracture. 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 Dupuytren’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 Dupuytren’s contracture and Peyronie’s disease in Canada, Australia, Brazil and Mexico.

Operational Highlights

On January 8, 2014, we announced top-line data from the phase II dose escalation clinical trial of CCH for the treatment of human lipoma. The primary efficacy outcome of active reduction of the visible surface area of the lipoma as measured by caliper was met, combining all patients (p<0.0001). There were no serious adverse events reported during the trial.

In January 2014, our partner Auxilium launched XIAFLEX, the first and only proven safe and effective FDA-approved treatment for Peyronie’s disease in men with a palpable plaque and a curvature deformity of >30° at the start of therapy. Peyronie’s disease can be a devastating disease for patients and their partners and is estimated to be prevalent in 3-9% of adult men.

On February 24, 2014, Auxilium announced that the FDA accepted their submission of a supplemental Biologics License Application (“sBLA”) requesting approval of XIAFLEX for the treatment of two Dupuytren’s contracture cords concurrently. The PDUFA date for the sBLA filing is October 20, 2014.

On April 7, 2014, our partner Auxilium and Sobi announced that Sobi became the Market Authorisation Holder (MAH) for XIAPEX in 28 EU member countries, Norway, and Iceland on April 3, 2014. As the MAH, Sobi has now elected to file for market authorization for XIAPEX for the treatment of Peyronie’s disease and work is on-going for that filing in the EU.

On April 14, 2014, our partner Auxilium and Sobi announced that encore data were presented from multiple clinical trials evaluating the use of XIAFLEX /XIAPEX in adult patients with Peyronie’s disease. These data were presented at the 29th Annual European Association of Urology (EAU) Congress held April 11-15, 2014 in Stockholm, Sweden.

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 Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC.

Principles of Consolidation
 
The audited consolidated financial statements include the accounts of the Company and its subsidiary, Advance Biofactures Corp. (“ABC-NY”).

Critical Accounting Policies, Estimates and Assumptions

The preparation of consolidated financial statements in conformity with U.S. GAAP requires the use of management’s estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. 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, and U.S. government securities.

Fair Value Measurements

Management believes that the carrying amounts of the Company’s financial instruments, including cash, cash equivalents, short-term investments, accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of those instruments.

Concentration of Credit Risk and Major Customers

The Company maintains bank account balances, which, at times, may exceed insured limits. The Company has not experienced any losses with these accounts and believes that it is not exposed to any significant credit risk on cash.

The Company maintains its investment in FDIC insured certificates of deposits with several banks.

At March 31, 2014, the accounts receivable balance of $1.9 million was from one customer, Auxilium.

The Company is dependent on one customer who generates almost all its revenues. In the quarter ended March 31, 2014, the licensing and royalty revenues from Auxilium were $2.7 million.

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 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 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 on 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 had the right to receive earn-out payments based on sales of certain products. This right to receive payments on Santyl sales expired in August 2013. 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 had sold the royalty-bearing product. DFB provided us earn-out reports on a quarterly basis. In 2013, BioSpecifics recognized all income from the Santyl sales under the DFB agreement, and in March 2014 we received the corresponding cash payment for the income recognized in 2013.

Licensing 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 FDA or other regulatory agencies require additional data or information, we would adjust our development period estimates accordingly. The impact on revenue of changes in our estimates and the timing thereof is recognized prospectively over the remaining estimated product development period.
Treasury Stock
 
The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders’ equity.
 
Receivables, Deferred Revenue 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 our one large pharmaceutical customer.  This company has historically paid timely and has been a financially stable organization.  Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.  If the financial condition of our customer were to deteriorate, adversely affecting its 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.
 
At March 31, 2014, the accounts receivable balance of $1.9 million was from one customer, Auxilium.
 
Deferred revenue of $0.2 million consists 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.
 
We recorded no material bad debt expense for the period ended March 31, 2014.  The allowance for doubtful accounts balance was approximately $30,000 at March 31, 2014 and 2013.
 
Reimbursable Third Party Development Costs

We estimate our accrual for patent expenses for research and development that are reimbursable by us under the Auxilium Agreement.  We increased our reimbursable third party patent cost based on the most recent information provided to us by Auxilium for the period ended March 31, 2014. We capitalize certain patent costs related to estimated third party development costs that are reimbursable under the Auxilium Agreement. As of March 31, 2014, our net reimbursable third party patent cost was approximately $192,000.

Third Party Royalties

We have entered into licensing and royalty agreements with third parties and agreed to pay certain royalties on net sales of products for specific indications.  We accrue third party royalty expenses on net sales reported to us by Auxilium. Third party royalty expense is generally expensed in the quarter that Auxilium provides the written reports and related information to us, that is, generally one quarter following the quarter in which the underlying sales by Auxilium occurred. We expect our third party royalty expense under General and Administrative expenses will continue to increase as net sales by Auxilium for XIAFLEX increase and potential new indications for CCH are approved.

Royalty Buy-Down

On March 31, 2012, we entered into an amendment to our existing agreement with Dr. Martin K. Gelbard, 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, one of which was paid in December 2013.
As of March 31, 2014, we have capitalized $3.35 million related to this agreement which will be amortized over approximately five years, beginning in the second quarter of 2014, 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. We perform an evaluation of the recoverability of the carrying value of our intangible assets to determine if facts and circumstances indicate that the carrying value of intangible assets may be impaired and if any adjustment is warranted. Based on our evaluation as of March 31, 2014, no impairment existed for intangible assets.
 
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. No stock options were granted during the three month period ended March 31, 2014.

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.
Stock-based compensation expense recognized under ASC 718 was as follows:

 
  
Three Months Ended
March 31,
  
 
  
2014
    
2013
  
Research and development
  
$
-
    
$
13,200
  
General and administrative
    
5,354
      
13,200
  
Total stock-based compensation expense
  
$
5,354
    
$
26,400
  

Stock Option Activity

A summary of our stock option activity during the three months ended March 31, 2014 is presented below:

Options
  
Total Number
of Shares
    
Weighted-Average
Exercise Price
  
Outstanding as of December 31, 2013
    
1,167,000
    
$
9.03
  
Granted
    
-
      
-
  
Forfeited
    
-
      
-
  
Exercised
    
(51,000
)
    
1.30
  
Expired
    
-
      
-
  
Outstanding as of March 31, 2014
    
1,116,000
    
$
9.38
  
 
                
Exercisable as of March 31, 2014
    
1,081,000
    
$
8.90
  

During the three months ended March 31, 2014 and 2013, $66,100 and zero, respectively, were received from stock options exercised by option holders.

The aggregate intrinsic value of options outstanding and exercisable as of March 31, 2014 was approximately $18.4 million. Aggregate intrinsic value represents the total pre-tax intrinsic value based on the closing price of our common stock of $25.92 on March 31, 2014, which would have been received by the option holders had all option holders exercised their options as of that date. We have approximately $74,000 in unrecognized compensation cost related to stock options outstanding as of March 31, 2014.

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.

Provision for 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.
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
March 31,
  
 
  
2014
    
2013
  
Stock options
    
643,313
      
598,498
  

4. COMPREHENSIVE INCOME (LOSS)

For the three months ended March 31, 2014 and 2013, 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:

 
  
March 31,
    
December 31,
  
 
  
2014
    
2013
  
Trade accounts payable and accrued expenses
  
$
551,189
    
$
$ 409,617
  
Accrued legal and other professional fees
    
145,531
      
61,538
  
Accrued payroll and related costs
    
180,365
      
163,122
  
 
                
Total
  
$
877,085
    
$
634,277
  

6. PATENT COSTS

We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, ranging from 1 to 13 years, and review for impairment on a quarterly basis and when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable.

For the three months ended March 31, 2014, we increased our capitalized patent costs by $151,000 based on the most current information reported to us by Auxilium. As of March 31, 2014, the Company’s estimated capitalized costs related to certain patent costs paid by Auxilium on behalf of the Company are approximately $192,000, which are reimbursable to Auxilium under the Auxilium Agreement.  These patent costs are creditable against future royalty revenues. For each period presented below net patent costs consisted of:

 
  
March 31,
    
December 31,
  
 
  
2014
    
2013
  
Patents
  
$
623,828
    
$
472,375
  
Accumulated Amortization
    
(301,221
)
    
(256,376
)
 
  
$
322,607
    
$
215,999
  

The amortization expense for patents for the three months ended March 31, 2014 was approximately $45,000. In the comparable period of 2013, the amortization expense for patents was approximately $16,000. The estimated aggregate amortization expense for each of the next five years is approximately as follows:

2015
  
$
38,000
  
2016
    
32,000
  
2017
    
32,000
  
2018
    
32,000
  
2019
    
32,000
  

7. PROVISION FOR INCOME TAXES

In determining our provision for income taxes, we consider all available information, including operating results, ongoing tax planning, and forecasts of future taxable income. The significant components of the Company's deferred tax assets pursuant to Accounting Standards Codification 740-10-50 consist of stock-based compensation and deferred revenues. For the three month period ended March 31, 2014, the provision for income taxes was $0.4 million.  For the three month period ended March 31, 2014, the valuation allowance with respect to the Company’s net deferred tax assets remained unchanged.  As of March 31, 2014, our remaining deferred tax assets were approximately $1.5 million.

For the three month period ended March 31, 2013, the provision for income taxes was $0.7 million.  For the three month period ended March 31, 2013, the valuation allowance with respect to the Company’s net deferred tax assets remained unchanged.  As of March 31, 2013, our remaining deferred tax assets were approximately $1.6 million.

8. SUBSEQUENT EVENTS

We have evaluated subsequent events for recognition or disclosure through the time of filing these consolidated financial statements on Form 10-Q with the SEC on May 9, 2014.

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 have a development and license agreement with Auxilium Pharmaceuticals, Inc. (“Auxilium”) for injectable collagenase (which Auxilium has named XIAFLEX®) for marketed indications and collagenase clostridium histolyticum (“CCH”) for indications in development. Auxilium has an option to acquire additional indications that we may pursue, including human and canine lipoma. Auxilium is currently selling XIAFLEX in the U.S. for the treatment of Dupuytren’s contracture and Peyronie’s disease. Following the termination of the agreement between Auxilium and Pfizer, Inc. (“Pfizer”),  Auxilium entered into an agreement with Swedish Orphan Biovitrum AB (“Sobi”) pursuant to which Sobi has marketing rights for XIAPEX® (the EU trade name for collagenase clostridium histolyticum) for Dupuytren’s contracture and Peyronie’s disease in Europe and certain Eurasian countries. Sobi is currently selling XIAPEX in Europe for the treatment of Dupuytren’s contracture. 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 Dupuytren’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 Dupuytren’s contracture and Peyronie’s disease in Canada, Australia, Brazil and Mexico.

Operational Highlights
 
On January 8, 2014, we announced top-line data from the phase II dose escalation clinical trial of CCH for the treatment of human lipoma. The primary efficacy outcome of active reduction of the visible surface area of the lipoma as measured by caliper was met, combining all patients (p<0.0001). There were no serious adverse events reported during the trial.
In January 2014, our partner Auxilium launched XIAFLEX, the first and only proven safe and effective FDA-approved treatment for Peyronie’s disease in men with a palpable plaque and a curvature deformity of >30° at the start of therapy. Peyronie’s disease can be a devastating disease for patients and their partners and is estimated to be prevalent in 3-9% of adult men.

On February 24, 2014, Auxilium announced that the FDA accepted their submission of a supplemental Biologics License Application (“sBLA”) requesting approval of XIAFLEX for the treatment of two Dupuytren’s contracture cords concurrently. The PDUFA date for the sBLA filing is October 20, 2014.

On April 7, 2014, our partner Auxilium and Sobi announced that Sobi became the Market Authorisation Holder (MAH) for XIAPEX in 28 EU member countries, Norway, and Iceland on April 3, 2014. As the MAH, Sobi has now elected to file for market authorization for XIAPEX for the treatment of Peyronie’s disease and work is on-going for that filing in the EU.

On April 14, 2014, our partner Auxilium and Sobi announced that encore data were presented from multiple clinical trials evaluating the use of XIAFLEX /XIAPEX in adult patients with Peyronie’s disease. These data were presented at the 29th Annual European Association of Urology (EAU) Congress held April 11-15, 2014 in Stockholm, Sweden.

Outlook

For the quarter ended March 31, 2014, we generated revenue from one primary source: in connection with the Auxilium Agreement.  Under the Auxilium Agreement, we receive license, sublicense income, royalties, milestones and mark-up on cost of goods sold payments related to the sale and approval of XIAFLEX 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 and Peyronie’s disease, successfully develop CCH 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 March 31, 2014 and for the three months ended March 31, 2014 and 2013 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, 2013 balance sheet amounts and disclosures included herein have been derived from the Company’s December 31, 2013 audited consolidated financial statements. The interim results are not necessarily indicative of results to be expected for the full fiscal year. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2013 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 7, 2014. 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 on 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 had the right to receive earn-out payments based on sales of certain products. This right to receive payments on Santyl sales expired in August 2013. 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 had sold the royalty-bearing product. DFB provided us earn-out reports on a quarterly basis. In 2013, BioSpecifics recognized all income from the Santyl sales under the DFB agreement, and, in March 2014 we received the corresponding cash payment for the income recognized in 2013.

Reimbursable Third Party Development Costs. We accrue 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. As of March 31, 2014 our estimated net reimbursable third party patent costs accrual was approximately $192,000.

Receivables and Deferred Revenue. Accounts receivable as of March 31, 2014 is approximately $1.9 million, which consists of royalties and mark-up on costs of goods sold due from Auxilium in accordance with the terms of the Auxilium Agreement. Deferred revenue of $0.2 million consists 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 with Dr. Martin K. Gelbard, 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, one of which was paid in December 2013.

As of March 31, 2014, we have capitalized $3.35 million related to this agreement which will be amortized over approximately five years, beginning in the second quarter of 2014, 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. We perform an evaluation of the recoverability of the carrying value of our intangible assets to determine if facts and circumstances indicate that the carrying value of intangible assets may be impaired and if any adjustment is warranted. Based on our evaluation as of March 31, 2014, no impairment existed for intangible assets.

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 MARCH 31, 2014 AND 2013

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 March 31, 2014 and 2013 product revenues were $3,678 and $2,243, respectively. This decrease 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 and mark-up on cost of goods sold for the three month period ended March 31, 2014 were $2.7 million as compared to royalty, mark-up on cost of goods sold and earn-out revenues of $3.4 million in the 2013 period, a decrease of $0.7 million or 20%. Royalty and the mark-up on cost of goods sold revenues recognized under the Auxilium Agreement were $2.7 million for the 2014 period compared to $2.4 million in the 2013 period. The increase of $0.3 million was due to increased net sales of XIAFLEX during 2014 period reported to us by Auxilium.
 
Under the earn-out payment provision of the DFB Agreement, we had the right to receive earn-out revenues from DFB after certain net sales levels were achieved. This right to receive payments on Santyl sales expired in August 2013. Revenues recognized under the DFB Agreement were zero for the three months ended March 31, 2014 as compared to $1.0 million in the 2013 period. The change in revenue was entirely due to the August 2013 expiration of the right to receive payments on Santyl.
Licensing Revenue
 
Licensing revenue consists of licensing fees, sublicensing fees and milestones. For the three months ended March 31, 2014 and 2013, we recognized total licensing and milestone revenue of approximately $17,283 and $544,881, respectively. Certain licensing fees recognized are related to the cash payments received under the Auxilium Agreement in prior years and amortized over the expected development period. For the three months ended March 31, 2014, we recognized licensing revenue related to the development of XIAFLEX of approximately $17,283 as compared to $44,881 in the 2013 period. In the 2013 period, licensing fees recognized of $0.5 million were related to the exercise by Auxilium of its exclusive option to expand the field of its license for injectable collagenase to include the potential treatment of adult patients with edematous fibrosclerotic panniculopathy, commonly known as cellulite.

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 $382,704 and $294,874, respectively, for the three months ended March 31, 2014 and 2013, representing an increase in 2014 of $87,830, or 30%. This increase in research and development expenses was primarily due to expenses related to our clinical development and research programs.
 
We are currently working to develop CCH for the treatment of human and canine lipoma and have begun a pre-clinical study in uterine fibroids.
 
The following table summarizes our research and development expenses related to our clinical development programs.
 
 
  
Three Months Ended
March 31, 2014
    
Three Months Ended
March 31, 2013
  
Program
  
   
 
Canine Lipoma
  
$
116,864
    
$
90,071
  
Human Lipoma
    
76,315
      
43,837
  
Uterine Fibroids
    
50,959
      
1,640
  

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 and CCH, 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 $1.2 million and $1.6 million for the three months ended March 31, 2014 and 2013, respectively, a decrease of approximately $0.4 million, or 23%, from 2013. The decrease in general and administrative expenses was due to lower third party licensing fees, legal, consulting services and investor relations partially offset by third party royalty fees.

Other Income and expense

Other income for the three months ended March 31, 2014 was $8,121 compared to $5,866 in the 2013 period. Other income in both periods consisted mostly of interest earned on our investments.

Provision for 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 March 31, 2014 our provision for income taxes was $0.4 million. The provision for income taxes for the three month period ended March 31, 2014 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 2013. For the three month period ended March 31, 2014, the valuation allowance with respect to our net deferred tax assets remained unchanged.  As of March 31, 2014, our remaining deferred tax assets were approximately $1.5 million.

For the three month period ended March 31, 2013 our provision for income taxes was $0.7 million. The provision for income taxes for the three month period ended March 31, 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 2013. For the three month period ended March 31, 2013, the valuation allowance with respect to our net deferred tax assets remained unchanged.  As of March 31, 2013, our remaining deferred tax assets were approximately $1.6 million.

Net Income

For the three months ended March 31, 2014 we recorded net income of $0.8 million, or $0.12 per basic common share and $0.11 per diluted common share, compared to net income of $1.4 million, or $0.21 per basic common share and $0.19 per diluted common share for the same period in 2013.
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 March 31, 2014 and December 31, 2013, we had cash and cash equivalents and investments in the aggregate of approximately $16.9 million and $12.6 million, respectively.

Net cash provided by operating activities for the three months ended March 31, 2014 and 2013 was $3.9 million. Cash provided by operations in the 2014 period resulted primarily from our operating income for the period, a payment of earn-out royalties due under the DFB Agreement on an annual basis and royalties and mark-up on cost goods sold revenues under the Auxilium Agreement. Cash provided by operations in the 2013 period resulted primarily from our operating income for the period, a payment of earn-out royalties due under the DFB Agreement on an annual basis and licensing fees, milestones, royalties and mark-up on cost goods sold revenues under the Auxilium Agreement.

Net cash used in investing activities for the three months ended March 31, 2014 was $1.0 million as compared to net cash provided by investing activities of $157,000 for the 2013 period. The net cash used in investing activities in the 2014 reflects the maturing of $2.2 million and reinvestment of $3.2 million in marketable securities. The net cash provided by investing activities in the 2013 period reflects the maturing of $3.2 and reinvestment of $3.0 million in marketable securities.

Net cash provided by financing activities for the three months ended March 31, 2014 was $0.4 million as compared to net cash used in financing activities of $0.2 million in the compared period of 2013. In the 2014 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 of $81,000. In the 2013 period, net cash used in financing activities was mainly due to the repurchase of our common stock under our stock repurchase program.

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.

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 March 31, 2014, amounting to approximately $16.9 million, were maintained in bank demand accounts, money market accounts, and certificates of deposit. 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, 2013.

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 nine month period ended March 31, 2014 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 7, 2014.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
 
During the three month period ended March 31, 2014, we did not issue any unregistered shares of securities.

Issuer Purchases of Equity Securities (1)

Period
  
Total Number of
Shares
Purchased (2)
    
Average
Price Paid
Per Share (3)
    
Total Number of
Shares
Purchased as
Part of Publicly
Announced Plan
    
Maximum
Number (or
Dollar Value) of
Shares that may
yet be Purchased
under the Plan
  
         
 
          
$
2,000,000
(5) 
January 1, 2014 – January 31, 2014
    
-
      
-
      
-
    
$
2,000,000
  
February 1, 2014 – February 28, 2014
    
960
    
$
20.77
      
170,432
    
$
1,980,058
  
March 1, 2014 – March 31, 2014
    
2,265
    
$
26.94
      
172,697
    
$
1,919,028
  

(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. On November 15, 2012, 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) On November 15, 2012, we announced that our Board of Directors had reauthorized the repurchase of up to $2.0 million of our common stock under the stock repurchase program.
(5) On December 10, 2013, we announced that our Board of Directors had 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. Mine Safety Disclosures
 
Not applicable.

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 Commission on March 2, 2007)
3.2
Registrant’s Amended and Restated By-laws as amended February 25, 2014 (incorporated by reference to Exhibit 3.2 of the Registrant’s Form 10-K filed with the Commission on March 7, 2014)
3.3
Amendment to Amended and Restated By-laws (incorporated by reference to Exhibit 3.1 of the Registrant’s Form 8-K filed with the Commission on February 26, 2014)
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.
 
 * 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: May 9, 2014
/s/ Thomas L. Wegman
 
Thomas L. Wegman
 
President, Principal Executive Officer and
  Principal Financial Officer
 
 
22
 EX-31 2 ex31.htm EXHIBIT 31
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 March 31, 2014 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: May 9, 2014
 
 
 
/s/ Thomas L. Wegman
 
Thomas L. Wegman
President, Principal Executive Officer and Principal Financial Officer
 

 EX-32 3 ex32.htm EXHIBIT 32
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 March 31, 2014 (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 May, 2014.

/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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ORGANIZATION AND DESCRIPTION OF BUSINESS</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">We are a biopharmaceutical company involved in the development of an injectable collagenase for multiple indications. We have a development and license agreement with Auxilium Pharmaceuticals, Inc. (&#8220;Auxilium&#8221;) for injectable collagenase (which Auxilium has named XIAFLEX<sup>&#174;</sup>) for marketed indications and collagenase clostridium histolyticum (&#8220;CCH&#8221;) for indications in development. Auxilium has an option to acquire additional indications that we may pursue, including human and canine lipoma. Auxilium is currently selling XIAFLEX in the U.S. for the treatment of Dupuytren&#8217;s contracture and Peyronie&#8217;s disease. Following the termination of the agreement between Auxilium and Pfizer, Inc. (&#8220;Pfizer&#8221;),&#160; Auxilium entered into an agreement with Swedish Orphan Biovitrum AB (&#8220;Sobi&#8221;) pursuant to which Sobi has marketing rights for XIAPEX<sup>&#174;</sup> (the EU trade name for collagenase clostridium histolyticum) for Dupuytren&#8217;s contracture and Peyronie&#8217;s disease in Europe and certain Eurasian countries. Sobi is currently selling XIAPEX in Europe for the treatment of Dupuytren&#8217;s contracture. In addition, Auxilium has an agreement with Asahi Kasei Pharma Corporation (&#8220;Asahi&#8221;) pursuant to which Asahi has the right to commercialize XIAFLEX for the treatment of Dupuytren&#8217;s contracture and Peyronie&#8217;s disease in Japan. Auxilium also has an agreement with Actelion Pharmaceuticals Ltd. (&#8220;Actelion&#8221;) pursuant to which Actelion has the right to commercialize XIAFLEX for the treatment of Dupuytren&#8217;s contracture and Peyronie&#8217;s disease in Canada, Australia, Brazil and Mexico.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">Operational Highlights</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">On January 8, 2014, we announced <font style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">top-line data from the phase II dose escalation clinical trial of CCH for the treatment of human lipoma. The primary efficacy outcome of active reduction of the visible surface area of the lipoma as measured by caliper was met, combining all patients (p&lt;0.0001). 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Leasehold improvements are amortized over the lesser of their estimated useful lives or the remaining life of the lease.</div></div> <div style="font-family: 'Times New Roman', Times, serif; font-size: 10pt;"><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">8. RELATED PARTY TRANSACTIONS</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Our corporate headquarters are currently located at 35 Wilbur St., Lynbrook, NY 11563.&#160; On November 21, 2013, the Company entered into an Agreement of Lease (the &#8220;New Lease&#8221;) with 35 Wilbur Street Associates, LLC (&#8220;New Landlord&#8221;) for the Company&#8217;s corporate headquarters located at 35 Wilbur Street, <font style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Lynbrook, New York 11563 (the &#8220;Premises&#8221;). 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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">Basis of Presentation</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; 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 (&#8220;U.S. GAAP&#8221;) has been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the &#8220;SEC&#8221;) for quarterly reporting.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The information included in this Report should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC.</div><div><br /></div><div style="text-align: left; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">Principles of Consolidation</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The audited consolidated financial statements include the accounts of the Company and its subsidiary, Advance Biofactures Corp. 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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, and U.S. government securities.</div><div><br /></div><div style="text-align: left; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">Fair Value Measurements</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Management believes that the carrying amounts of the Company&#8217;s financial instruments, including cash, cash equivalents, short-term investments, accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of those instruments.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">Concentration of Credit Risk and Major Customers</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The Company maintains bank account balances, which, at times, may exceed insured limits. The Company has not experienced any losses with these accounts and believes that it is not exposed to any significant credit risk on cash.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The Company maintains its investment in FDIC insured certificates of deposits with several banks.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">At March 31, 2014, the accounts receivable balance of $1.9 million was from one customer, Auxilium.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The Company is dependent on one customer who generates almost all its revenues. 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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'', Times, 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'', Times, 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'', Times, 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 or earn-out payment revenues are generally recognized in the quarter that the applicable licensee provides the written report and related information to us.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">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 on the cost of goods sold revenues. 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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. DFB has provided us earn-out reports on a quarterly basis. 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As product candidates move through the development process, it is necessary to revise these estimates to consider changes to the product development cycle, such as changes in the clinical development plan, regulatory requirements, or various other factors, many of which may be outside of our control. Should the FDA or other regulatory agencies require additional data or information, we would adjust our development period estimates accordingly. 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revenue Deferred revenue Deferred Revenue, Current Deferred tax assets - long term Depreciation and amortization Accrued liabilities of discontinued operations Diluted net income per share (in dollars per share) Basic net income per share (in dollars per share) NET INCOME (LOSS) PER SHARE Earnings Per Share [Text Block] NET INCOME (LOSS) PER SHARE [Abstract] Accrued payroll and related costs Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] Employee Service Share-based Compensation, Allocation of Recognized Period Costs, Report Line [Domain] Unrecognized compensation cost related to non-vested stock options outstanding Excess tax benefits from share-based payment arrangements Excess Tax Benefit (Tax Deficiency) from Share-based Compensation, Financing Activities Fair Value Measurements Estimated useful lives Finite-Lived Intangible Asset, Useful Life Finite-Lived Intangible Assets, Major Class Name [Domain] Increase in capitalized patent costs Finite-Lived Intangible Assets, Period Increase (Decrease) 2019 Finite-Lived Intangible Assets, Amortization Expense, Year Five Finite-Lived Intangible Assets [Line Items] 2017 Estimated amortization expense [Abstract] Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract] Finite-Lived Intangible Assets by Major Class [Axis] Accumulated Amortization Finite-Lived Intangible Assets, Accumulated Amortization Net Patent Costs [Abstract] Finite-Lived Intangible Assets, Net [Abstract] Patents 2015 2018 2016 Finite-Lived Intangible Assets, Amortization Expense, Year Two Gain on the sale of fixed assets Gain (Loss) on Sale of Property Plant Equipment General and administrative General and Administrative [Member] PATENT COSTS [Abstract] Income before expense for income tax Income (Loss) from Continuing Operations before Income Taxes, Extraordinary Items, Noncontrolling Interest Consolidated Statements of Operations (unaudited) [Abstract] PROVISION FOR INCOME TAXES Income Tax Disclosure [Text Block] PROVISION FOR INCOME TAXES [Abstract] Net income tax expense (benefit) Income tax benefit (expense) Income Tax Expense (Benefit) Income tax receivable Provision for Income Taxes Taxes Deferred tax assets Increase (Decrease) in Deferred Income Taxes Accrued taxes payable Deferred revenue Increase (Decrease) in Deferred Revenue Accounts receivable Increase (Decrease) in Accounts Receivable Accounts payable and accrued expenses Prepaid expenses and other current assets Increase (Decrease) in Prepaid Expense and Other Assets Changes in operating assets and liabilities: Stock options (in shares) PATENT COSTS Intangible Assets Disclosure [Text Block] Patent costs, net Net patent costs Interest Interest income Investment Income, Interest Total current liabilities Liabilities, Current Current liabilities: Liabilities and Stockholders' Equity Total liabilities and stockholders' equity Liabilities and Equity Licensing revenues Major Customers [Axis] Maximum [Member] Minimum [Member] Name of Major Customer [Domain] Cash flows from financing activities: Net cash provided by (used in) investing activities Net Cash Provided by (Used in) Investing Activities Net cash used in financing activities Net Cash Provided by (Used in) Financing Activities Cash flows from investing activities: Cash flows from operating activities: Net Cash Provided by (Used in) Operating Activities [Abstract] Net income Net income Net cash provided by operating activities Net Cash Provided by (Used in) Operating Activities Supplemental disclosures of non-cash transactions: Total other income (expense) Nonoperating Income (Expense) Other income (expense): Operating income Operating Income (Loss) Monthly rental price ORGANIZATION AND DESCRIPTION OF BUSINESS [Abstract] ORGANIZATION AND DESCRIPTION OF BUSINESS Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] Other comprehensive income (loss) Other income Other Nonoperating Income (Expense) Patents [Member] ACCOUNTS PAYABLE AND ACCRUED EXPENSES [Abstract] Payments for repurchase of common stock Payments for Repurchase of Common Stock Purchases of marketable investments Payments to Acquire Marketable Securities Series A Preferred stock, $.50 par value, 700,000 shares authorized; none outstanding Series A Preferred stock, authorized (in shares) Series A Preferred stock, par value (in dollars per share) Series A Preferred stock, outstanding (in shares) Prepaid expenses and other current assets Maturity of marketable investments Proceeds from sale of fixed asset Proceeds from stock option exercises Estimated useful life of property, plant and equipment Property, Plant and Equipment [Abstract] Property, Plant and Equipment [Abstract] Property, Plant and Equipment Property, Plant and Equipment [Line Items] Range [Axis] Range [Domain] RELATED PARTY TRANSACTIONS Related Party Transactions Disclosure [Text Block] RELATED PARTY TRANSACTIONS [Abstract] Research and development Research and Development [Member] Research and Development Expenses Retained earnings Revenue Recognition Royalties Royalty revenue Aggregate intrinsic value of options outstanding and exercisable Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value Estimated Aggregate Future Amortization Expense Schedule of Finite-Lived Intangible Assets, Future Amortization Expense [Table Text Block] Net sales Total Revenues Revenue, Net Revenues: Summary of Stock Option Activity Schedule of Finite-Lived Intangible Assets [Table] Accounts Payable and Accrued Expenses Schedule of Accounts Payable and Accrued Liabilities [Table Text Block] Net Patent Costs Schedule of Finite-Lived Intangible Assets [Table Text Block] Number of Common Equivalent Shares Included for the Calculation of Diluted Net Income Schedule of Weighted Average Number of Shares [Table Text Block] Schedule of Collaborative Arrangements and Non-collaborative Arrangement Transactions [Table] Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs, by Report Line [Axis] Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table] Stock-Based Compensation Expense Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] Schedule of Property, Plant and Equipment [Table] Stock-based compensation expense Forfeited (in dollars per share) Weighted-Average Exercise Price Granted (in shares) Closing price of Company stock (in dollars per share) Share Price Granted (in dollars per share) Expired (in dollars per share) Exercised (in dollars per share) Exercisable, end of period (in dollars per share) Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price Expired (in shares) Share-based Compensation Arrangement by Share-based Payment Award, Options, Expirations in Period Exercisable, end of period (in shares) Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number Total number of shares Forfeited (in shares) Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures and Expirations in Period Outstanding, beginning of period (in dollars per share) Outstanding, end of period (in dollars per share) Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price Outstanding, beginning of period (in shares) Outstanding, end of period (in shares) Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number Stock-Based Compensation Short-term investments SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Significant Accounting Policies [Text Block] Consolidated Statements of Cash Flows (unaudited) [Abstract] Consolidated Balance Sheets (unaudited) [Abstract] Consolidated Statements of Comprehensive Income (unaudited) [Abstract] Exercised (in shares) Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period Stockholders' equity: Total stockholders' equity Stockholders' Equity Attributable to Parent SUBSEQUENT EVENTS Subsequent Events [Text Block] SUBSEQUENT EVENTS [Abstract] Subsequent Event Type [Domain] Subsequent Event Type [Axis] Subsequent Event [Member] Supplemental disclosures of cash flow information: Receivables, Deferred Revenue and Allowance for Doubtful Accounts Treasury stock, 303,964 and 300,739 shares at cost at March 31, 2014 and December 31, 2013, respectively Treasury Stock, Value Treasury stock, shares (in shares) Critical Accounting Policies, Estimates and Assumptions Use of Estimates, Policy [Policy Text Block] 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) Represents the period of notice that can given before the expiration of first year of lease rental. Period of notice that can given before the expiration of first year of lease rental Represents the term of lease rental. Term of lease rental 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 Patent costs accrued from Auxilium 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 Disclosure of accounting policy for third party royalties. Third Party Royalties [Policy Text Block] Third-Party Royalties Disclosure of accounting policy for clinical trial expenses. Clinical Trial Expenses [Policy Text Block] Clinical Trial Expenses Disclosure of accounting policy for royalty buy down. Royalty Buy Down [Policy Text Block] Royalty Buy-Down 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 treasury stock. Treasury Stock [Policy Text Block] Treasury Stock Number of stock based compensation plans in effect for employees and directors. Number of stock based compensation plans in effect Royalty Buy Down [Abstract] Royalty Buy-Down [Abstract] The cash outflow from initial payment related to the purchase of royalty interests. Payment for royalty buy down Initial payment for royalty buy down The duration period related to the amortization of deferred cost. Deferred Costs Amortization Period Deferred costs, amortization period Royalty Mark up on Cost of Goods Sold Earn Out Revenue [Abstract] Royalty / Mark-up on Cost of Goods Sold / Earn-Out Revenue [Abstract] Reimbursable Third Party Development Costs [Abstract] Reimbursable Third Party Development Costs [Abstract] Share based compensation stock options activity [Abstract] 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 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 Accrued patent costs The number of additional cash payments for royalty buy-down. Number of additional cash payments for royalty buy down This line item represents one of the major pharmaceutical customer of the entity from which a large part of revenue is generated. Auxilium [Member] Concentration of Credit Risk and Major Customers [Abstract] Number of Customers from which Company is getting revenue is being generated. Number of Customers Number of customers 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) Represents the capitalized patents costs reimbursable to customer. Capitalized patents costs reimbursable to customer Represents the number of DC cords that can used concurrently for treatment. Number of DC cords that can used concurrently for treatment Refers to Percentage of estimation of PD being prevalent in adult men. Percentage of estimation of PD being prevalent in adult men Percentage prevalent of adults for divesting deceased patients (in hundredths) Represents number of EU countries in which marketing rights of XIAPEX held by Swedish Orphan Biovitrum AB ("Sobi"). 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ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) (USD $)
Mar. 31, 2014
Dec. 31, 2013
Accounts payable and accrued expenses [Abstract]    
Trade accounts payable and accrued expenses $ 551,189 $ 409,617
Accrued legal and other professional fees 145,531 61,538
Accrued payroll and related costs 180,365 163,122
Total $ 877,084 $ 634,277
XML 13 R9.htm IDEA: XBRL DOCUMENT v2.4.0.8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 3 Months Ended
Mar. 31, 2014
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 Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC.

Principles of Consolidation
The audited consolidated financial statements include the accounts of the Company and its subsidiary, Advance Biofactures Corp. (“ABC-NY”).

Critical Accounting Policies, Estimates and Assumptions

The preparation of consolidated financial statements in conformity with U.S. GAAP requires the use of management’s estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. 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, and U.S. government securities.

Fair Value Measurements

Management believes that the carrying amounts of the Company’s financial instruments, including cash, cash equivalents, short-term investments, accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of those instruments.

Concentration of Credit Risk and Major Customers

The Company maintains bank account balances, which, at times, may exceed insured limits. The Company has not experienced any losses with these accounts and believes that it is not exposed to any significant credit risk on cash.

The Company maintains its investment in FDIC insured certificates of deposits with several banks.

At March 31, 2014, the accounts receivable balance of $1.9 million was from one customer, Auxilium.

The Company is dependent on one customer who generates almost all its revenues. In the quarter ended March 31, 2014, the licensing and royalty revenues from Auxilium were $2.7 million.

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 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 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 on 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 had the right to receive earn-out payments based on sales of certain products. This right to receive payments on Santyl sales expired in August 2013. 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. DFB has provided us earn-out reports on a quarterly basis. In 2013, BioSpecifics recognized all income from the Santyl sales under the DFB agreement, and in March 2014 we received the corresponding cash payment, for the income recognized in 2013.

Licensing 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 FDA or other regulatory agencies require additional data or information, we would adjust our development period estimates accordingly. The impact on revenue of changes in our estimates and the timing thereof is recognized prospectively over the remaining estimated product development period.
 
Treasury Stock
 
The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders’ equity.
 
Receivables, Deferred Revenue 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 our one large pharmaceutical customer.  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.
At March 31, 2014, the accounts receivable balance of $1.9 million was from one customer, Auxilium.
 
Deferred revenue of $0.2 million consists 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.
 
We recorded no material bad debt expense for the period ended March 31, 2014.  The allowance for doubtful accounts balance was approximately $30,000 at March 31, 2014 and 2013.
 
Reimbursable Third Party Development Costs

We estimate our accrual for patent expenses for research and development that are reimbursable by us under the Auxilium Agreement.  We increased our reimbursable third party patent cost based on the most recent information provided to us by Auxilium for the period ended March 31, 2014. We capitalize certain patent costs related to estimated third party development costs that are reimbursable under the Auxilium Agreement. As of March 31, 2014, our net reimbursable third party patent cost was approximately $192,000.

Third-Party Royalties

We have entered into licensing and royalty agreements with third parties and agreed to pay certain royalties on net sales of products for specific indications.  We accrue third-party royalty expenses on net sales reported to us by Auxilium. Third-party royalty expense is generally expensed in the quarter that Auxilium provides the written reports and related information to us, that is, generally one quarter following the quarter in which the underlying sales by Auxilium occurred. We expect our third party royalty expense under General and Administrative expenses will continue to increase as net sales by Auxilium for XIAFLEX increase and potential new indications for CCH are approved.

Royalty Buy-Down

On March 31, 2012, we entered into an amendment to our existing agreement with Dr. Martin K. Gelbard, 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, one of which was paid in December 2013.

As of March 31, 2014, we have capitalized $3.35 million related to this agreement which will be amortized over approximately five years, beginning in the second quarter of 2014, 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. We perform an evaluation of the recoverability of the carrying value of our intangible assets to determine if facts and circumstances indicate that the carrying value of intangible assets may be impaired and if any adjustment is warranted. Based on our evaluation as of March 31, 2014, no impairment existed for intangible assets.
 
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. No stock options were granted during the three month period ended March 31, 2014.

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.

Stock-based compensation expense recognized under ASC 718 was as follows:

 
 
Three Months Ended
March 31,
 
 
 
2014
  
2013
 
Research and development
 
$
-
  
$
13,200
 
General and administrative
  
5,354
   
13,200
 
Total stock-based compensation expense
 
$
5,354
  
$
26,400
 

Stock Option Activity

A summary of our stock option activity during the three months ended March 31, 2014 is presented below:

 
 
Total
Number
  
Weighted-Average
 
Options
 
of Shares
  
Exercise Price
 
Outstanding as of December 31, 2013
  
1,167,000
  
$
9.03
 
Granted
  
-
   
-
 
Forfeited
  
-
   
-
 
Exercised
  
(51,000
)
  
1.30
 
Expired
  
-
   
-
 
Outstanding as of March 31, 2014
  
1,116,000
  
$
9.38
 
 
Exercisable as of March 31, 2014
 
1,081,000
$
8.90
 
During the three months ended March 31, 2014 and 2013, $66,100 and zero, respectively, were received from stock options exercised by option holders.

The aggregate intrinsic value of options outstanding and exercisable as of March 31, 2014 was approximately $18.4 million. Aggregate intrinsic value represents the total pre-tax intrinsic value based on the closing price of our common stock of $25.92 on March 31, 2014, which would have been received by the option holders had all option holders exercised their options as of that date. We have approximately $74,000 in unrecognized compensation cost related to stock options outstanding as of March 31, 2014.

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.

Provision for 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.
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 3 Months Ended
Mar. 31, 2014
RELATED PARTY TRANSACTIONS [Abstract]  
Term of lease rental 24 months
Period of notice that can given before the expiration of first year of lease rental 3 months
Monthly rental price $ 12,000
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ORGANIZATION AND DESCRIPTION OF BUSINESS
 3 Months Ended
Mar. 31, 2014
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 have a development and license agreement with Auxilium Pharmaceuticals, Inc. (“Auxilium”) for injectable collagenase (which Auxilium has named XIAFLEX®) for marketed indications and collagenase clostridium histolyticum (“CCH”) for indications in development. Auxilium has an option to acquire additional indications that we may pursue, including human and canine lipoma. Auxilium is currently selling XIAFLEX in the U.S. for the treatment of Dupuytren’s contracture and Peyronie’s disease. Following the termination of the agreement between Auxilium and Pfizer, Inc. (“Pfizer”),  Auxilium entered into an agreement with Swedish Orphan Biovitrum AB (“Sobi”) pursuant to which Sobi has marketing rights for XIAPEX® (the EU trade name for collagenase clostridium histolyticum) for Dupuytren’s contracture and Peyronie’s disease in Europe and certain Eurasian countries. Sobi is currently selling XIAPEX in Europe for the treatment of Dupuytren’s contracture. 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 Dupuytren’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 Dupuytren’s contracture and Peyronie’s disease in Canada, Australia, Brazil and Mexico.

Operational Highlights

On January 8, 2014, we announced top-line data from the phase II dose escalation clinical trial of CCH for the treatment of human lipoma. The primary efficacy outcome of active reduction of the visible surface area of the lipoma as measured by caliper was met, combining all patients (p<0.0001). There were no serious adverse events reported during the trial.
On February 24, 2014, Auxilium announced that the FDA accepted their submission of an sBLA requesting approval of XIAFLEX for the treatment of two DC cords concurrently. The PDUFA date for the sBLA filing is October 20, 2014.

In January 2014, our partner Auxilium launched XIAFLEX, the first and only proven safe and effective FDA-approved treatment for PD in men with a palpable plaque and a curvature deformity of >30° at the start of therapy. PD can be a devastating disease for patients and their partners and is estimated to be prevalent in 3-9% of adult men.

On April 7, 2014, our partner Auxilium and Sobi announced that Sobi became the Market Authorisation Holder (MAH) for XIAPEX in 28 EU member countries, Norway, and Iceland on April 3, 2014. As the MAH, Sobi has now elected to file for market authorization for XIAPEX for the treatment of PD and work is on-going for that filing in the EU.

On April 14, 2014, our partner Auxilium and Sobi announced that encore data were presented from multiple clinical trials evaluating the use of XIAFLEX /Xiapex in adult patients with PD. These data were presented at the 29th Annual European Association of Urology (EAU) Congress held April 11-15, 2014 in Stockholm, Sweden.
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Consolidated Balance Sheets (unaudited) (USD $)
Mar. 31, 2014
Dec. 31, 2013
Current assets:    
Cash and cash equivalents $ 8,934,794 $ 5,624,860
Short-term investments 7,973,002 6,966,964
Accounts receivable, net 1,921,810 5,004,418
Income tax receivable 293,976 255,708
Deferred tax assets 97,537 94,992
Prepaid expenses and other current assets 327,947 326,519
Total current assets 19,549,066 18,273,461
Deferred royalty buy-down 3,350,000 3,350,000
Deferred tax assets - long term 1,405,219 1,412,784
Patent costs, net 322,607 215,999
Total assets 24,626,892 23,252,244
Current liabilities:    
Accounts payable and accrued expenses 877,084 634,277
Deferred revenue 69,130 69,130
Accrued liabilities of discontinued operations 78,138 78,138
Total current liabilities 1,024,352 781,545
Long-term deferred revenue 120,978 138,260
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 ; 6,706,167 and 6,655,168 shares issued at March 31, 2014 and December 31, 2013, respectively 6,706 6,655
Additional paid-in capital 21,427,849 20,951,796
Retained earnings 5,729,008 4,975,018
Treasury stock, 303,964 and 300,739 shares at cost at March 31, 2014 and December 31, 2013, respectively (3,682,001) (3,601,030)
Total stockholders' equity 23,481,562 22,332,439
Total liabilities and stockholders' equity $ 24,626,892 $ 23,252,244
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Consolidated Statements of Cash Flows (unaudited) (USD $)
 3 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Cash flows from operating activities:    
Net income $ 753,989 $ 1,353,084
Adjustments to reconcile net income to net cash provided By operating activities:    
Depreciation and amortization 44,845 16,081
Stock-based compensation expense 5,354 26,400
Deferred tax assets 5,020 18,831
Gain on the sale of fixed assets (1,150) 0
Changes in operating assets and liabilities:    
Accounts receivable 3,082,608 2,172,214
Prepaid expenses and other current assets (39,696) (214,129)
Accounts payable and accrued expenses 91,356 253,070
Accrued taxes payable 0 332,924
Deferred revenue (17,283) (44,881)
Net cash provided by operating activities 3,925,043 3,913,594
Cash flows from investing activities:    
Maturity of marketable investments 2,206,964 3,200,000
Purchases of marketable investments (3,213,002) (3,042,964)
Proceeds from sale of fixed asset 1,150 0
Net cash provided by (used in) investing activities (1,004,888) 157,036
Cash flows from financing activities:    
Proceeds from stock option exercises 66,100 0
Payments for repurchase of common stock (80,971) (205,949)
Excess tax benefits from share-based payment arrangements 404,650  
Net cash used in financing activities 389,779 (205,949)
Increase in cash and cash equivalents 3,309,934 3,864,681
Cash and cash equivalents at beginning of year 5,624,860 3,383,737
Cash and cash equivalents at end of period 8,934,794 7,248,418
Cash paid during the year for:    
Interest 0 0
Taxes $ 15,000 $ 378,500
XML 19 R22.htm IDEA: XBRL DOCUMENT v2.4.0.8
ORGANIZATION AND DESCRIPTION OF BUSINESS (Details)
 3 Months Ended 3 Months Ended
Mar. 31, 2014
Cord
Apr. 07, 2014
Subsequent Event [Member]
Country
Mar. 31, 2014
Minimum [Member]
Mar. 31, 2014
Maximum [Member]
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]        
Number of DC cords that can used concurrently for treatment 2      
Percentage prevalent of adults for divesting deceased patients (in hundredths)     3.00% 9.00%
Number of EU countries in which marketing rights of XIAPEX held   28    
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NET INCOME (LOSS) PER SHARE (Details)
 3 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Number of common equivalent shares included for the calculation of diluted net income [Abstract]    
Stock options (in shares) 643,313 598,498
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Consolidated Statements of Cash Flows (unaudited) (Parenthetical) (USD $)
 3 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Supplemental disclosures of non-cash transactions:    
Patent costs accrued from Auxilium $ 151,000 $ 10,000
Patent amortization expenses $ 45,000 $ 16,000
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Consolidated Balance Sheets (unaudited) (Parenthetical) (USD $)
Mar. 31, 2014
Dec. 31, 2013
Stockholders' equity:    
Series A Preferred stock, par value (in dollars per share) $ 0.50 $ 0.50
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) 6,706,167 6,655,168
Treasury stock, shares (in shares) 303,964 300,739
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
 3 Months Ended
Mar. 31, 2014
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 Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC.
Principles of Consolidation
Principles of Consolidation
The audited consolidated financial statements include the accounts of the Company and its subsidiary, Advance Biofactures Corp. (“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 the use of management’s estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. 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, and U.S. government securities.
Fair Value Measurements
Fair Value Measurements

Management believes that the carrying amounts of the Company’s financial instruments, including cash, cash equivalents, short-term investments, accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of those instruments.
Concentration of Credit Risk and Major Customers
Concentration of Credit Risk and Major Customers

The Company maintains bank account balances, which, at times, may exceed insured limits. The Company has not experienced any losses with these accounts and believes that it is not exposed to any significant credit risk on cash.

The Company maintains its investment in FDIC insured certificates of deposits with several banks.

At March 31, 2014, the accounts receivable balance of $1.9 million was from one customer, Auxilium.

The Company is dependent on one customer who generates almost all its revenues. In the quarter ended March 31, 2014, the licensing and royalty revenues from Auxilium were $2.7 million.
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 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 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 on 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 had the right to receive earn-out payments based on sales of certain products. This right to receive payments on Santyl sales expired in August 2013. 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. DFB has provided us earn-out reports on a quarterly basis. In 2013, BioSpecifics recognized all income from the Santyl sales under the DFB agreement, and in March 2014 we received the corresponding cash payment, for the income recognized in 2013.

Licensing 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 FDA or other regulatory agencies require additional data or information, we would adjust our development period estimates accordingly. The impact on revenue of changes in our estimates and the timing thereof is recognized prospectively over the remaining estimated product development period.
Treasury Stock
Treasury Stock
 
The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders’ equity.
Receivables, Deferred Revenue and Allowance for Doubtful Accounts
Receivables, Deferred Revenue 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 our one large pharmaceutical customer.  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.
At March 31, 2014, the accounts receivable balance of $1.9 million was from one customer, Auxilium.
 
Deferred revenue of $0.2 million consists 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.
 
We recorded no material bad debt expense for the period ended March 31, 2014.  The allowance for doubtful accounts balance was approximately $30,000 at March 31, 2014 and 2013.
Reimbursable Third Party Development Costs
Reimbursable Third Party Development Costs

We estimate our accrual for patent expenses for research and development that are reimbursable by us under the Auxilium Agreement.  We increased our reimbursable third party patent cost based on the most recent information provided to us by Auxilium for the period ended March 31, 2014. We capitalize certain patent costs related to estimated third party development costs that are reimbursable under the Auxilium Agreement. As of March 31, 2014, our net reimbursable third party patent cost was approximately $192,000.
Third-Party Royalties
Third-Party Royalties

We have entered into licensing and royalty agreements with third parties and agreed to pay certain royalties on net sales of products for specific indications.  We accrue third-party royalty expenses on net sales reported to us by Auxilium. Third-party royalty expense is generally expensed in the quarter that Auxilium provides the written reports and related information to us, that is, generally one quarter following the quarter in which the underlying sales by Auxilium occurred. We expect our third party royalty expense under General and Administrative expenses will continue to increase as net sales by Auxilium for XIAFLEX increase and potential new indications for CCH are approved.
Royalty Buy-Down
Royalty Buy-Down

On March 31, 2012, we entered into an amendment to our existing agreement with Dr. Martin K. Gelbard, 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, one of which was paid in December 2013.

As of March 31, 2014, we have capitalized $3.35 million related to this agreement which will be amortized over approximately five years, beginning in the second quarter of 2014, 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. We perform an evaluation of the recoverability of the carrying value of our intangible assets to determine if facts and circumstances indicate that the carrying value of intangible assets may be impaired and if any adjustment is warranted. Based on our evaluation as of March 31, 2014, no impairment existed for intangible assets.
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. No stock options were granted during the three month period ended March 31, 2014.

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.

Stock-based compensation expense recognized under ASC 718 was as follows:

 
 
Three Months Ended
March 31,
 
 
 
2014
  
2013
 
Research and development
 
$
-
  
$
13,200
 
General and administrative
  
5,354
   
13,200
 
Total stock-based compensation expense
 
$
5,354
  
$
26,400
 

Stock Option Activity

A summary of our stock option activity during the three months ended March 31, 2014 is presented below:

 
 
Total
Number
  
Weighted-Average
 
Options
 
of Shares
  
Exercise Price
 
Outstanding as of December 31, 2013
  
1,167,000
  
$
9.03
 
Granted
  
-
   
-
 
Forfeited
  
-
   
-
 
Exercised
  
(51,000
)
  
1.30
 
Expired
  
-
   
-
 
Outstanding as of March 31, 2014
  
1,116,000
  
$
9.38
 
 
Exercisable as of March 31, 2014
 
1,081,000
$
8.90
 
During the three months ended March 31, 2014 and 2013, $66,100 and zero, respectively, were received from stock options exercised by option holders.

The aggregate intrinsic value of options outstanding and exercisable as of March 31, 2014 was approximately $18.4 million. Aggregate intrinsic value represents the total pre-tax intrinsic value based on the closing price of our common stock of $25.92 on March 31, 2014, which would have been received by the option holders had all option holders exercised their options as of that date. We have approximately $74,000 in unrecognized compensation cost related to stock options outstanding as of March 31, 2014.
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.
Provision for Income Taxes
Provision for 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.
XML 25 R1.htm IDEA: XBRL DOCUMENT v2.4.0.8
Document and Entity Information
 3 Months Ended
Mar. 31, 2014
May 06, 2014
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   0
Document Fiscal Year Focus 2014  
Document Fiscal Period Focus Q1  
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Mar. 31, 2014  
XML 26 R18.htm IDEA: XBRL DOCUMENT v2.4.0.8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
 3 Months Ended
Mar. 31, 2014
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
Stock-Based Compensation Expense
Stock-based compensation expense recognized under ASC 718 was as follows:

 
 
Three Months Ended
March 31,
 
 
 
2014
  
2013
 
Research and development
 
$
-
  
$
13,200
 
General and administrative
  
5,354
   
13,200
 
Total stock-based compensation expense
 
$
5,354
  
$
26,400
 
Summary of Stock Option Activity
A summary of our stock option activity during the three months ended March 31, 2014 is presented below:

 
 
Total
Number
  
Weighted-Average
 
Options
 
of Shares
  
Exercise Price
 
Outstanding as of December 31, 2013
  
1,167,000
  
$
9.03
 
Granted
  
-
   
-
 
Forfeited
  
-
   
-
 
Exercised
  
(51,000
)
  
1.30
 
Expired
  
-
   
-
 
Outstanding as of March 31, 2014
  
1,116,000
  
$
9.38
 
 
Exercisable as of March 31, 2014
 
1,081,000
$
8.90
XML 27 R4.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statements of Operations (unaudited) (USD $)
 3 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Revenues:    
Net sales $ 3,678 $ 2,243
Royalties 2,740,318 3,432,900
Licensing revenues 17,283 544,881
Total Revenues 2,761,279 3,980,024
Costs and expenses:    
Research and development 382,704 294,874
General and administrative 1,246,305 1,618,482
Total Cost and Expenses 1,629,009 1,913,356
Operating income 1,132,270 2,066,668
Other income (expense):    
Interest income 6,971 5,866
Other income 1,150 0
Total other income (expense) 8,121 5,866
Income before expense for income tax 1,140,391 2,072,534
Income tax benefit (expense) (386,402) (719,450)
Net income $ 753,989 $ 1,353,084
Basic net income per share (in dollars per share) $ 0.12 $ 0.21
Diluted net income per share (in dollars per share) $ 0.11 $ 0.19
Shares used in computation of basic net income per share (in shares) 6,378,859 6,356,954
Shares used in computation of diluted net income per share (in shares) 7,022,172 6,955,452
XML 28 R12.htm IDEA: XBRL DOCUMENT v2.4.0.8
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
 3 Months Ended
Mar. 31, 2014
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:

 
 
March 31,
  
December 31,
 
 
 
2014
  
2013
 
Trade accounts payable and accrued expenses
 
$
551,189
  
$
$ 409,617
 
Accrued legal and other professional fees
  
145,531
   
61,538
 
Accrued payroll and related costs
  
180,365
   
163,122
 
 
Total
$
877,085
$
634,277
XML 29 R11.htm IDEA: XBRL DOCUMENT v2.4.0.8
COMPREHENSIVE INCOME (LOSS)
 3 Months Ended
Mar. 31, 2014
COMPREHENSIVE INCOME (LOSS) [Abstract]  
COMPREHENSIVE INCOME (LOSS)
4. COMPREHENSIVE INCOME (LOSS)

For the three months ended March 31, 2014 and 2013, we had no components of other comprehensive income or loss other than net income itself.
XML 30 R23.htm IDEA: XBRL DOCUMENT v2.4.0.8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) (USD $)
 3 Months Ended
Mar. 31, 2014
Quarter
Plan
Customer
Mar. 31, 2013
Mar. 31, 2012
Payment
Dec. 31, 2013
Concentration of Credit Risk and Major Customers [Abstract]        
Accounts receivable $ 1,921,810     $ 5,004,418
Number of customers 1      
Royalty revenue 2,740,318 3,432,900    
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 90 days      
Allowance for doubtful accounts 30,000 30,000    
Reimbursable Third Party Development Costs [Abstract]        
Accrued patent costs 192,000      
Royalty Buy-Down [Abstract]        
Initial payment for royalty buy down     1,500,000  
Number of additional cash payments for royalty buy down     5  
Deferred royalty buy-down 3,350,000     3,350,000
Deferred costs, amortization period 5 years      
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]        
Number of stock based compensation plans in effect 2      
Stock-based compensation expense 5,354 26,400    
Total number of shares        
Outstanding, beginning of period (in shares) 1,167,000      
Granted (in shares) 0      
Forfeited (in shares) 0      
Exercised (in shares) (51,000)      
Expired (in shares) 0      
Outstanding, end of period (in shares) 1,116,000      
Exercisable, end of period (in shares) 1,081,000      
Weighted-Average Exercise Price        
Outstanding, beginning of period (in dollars per share) $ 9.03      
Granted (in dollars per share) $ 0      
Forfeited (in dollars per share) $ 0      
Exercised (in dollars per share) $ 1.30      
Expired (in dollars per share) $ 0      
Outstanding, end of period (in dollars per share) $ 9.38      
Exercisable, end of period (in dollars per share) $ 8.90      
Proceeds from stock option exercises 66,100 0    
Aggregate intrinsic value of options outstanding and exercisable 18,400,000      
Closing price of Company stock (in dollars per share) $ 25.92      
Unrecognized compensation cost related to non-vested stock options outstanding 74,000      
Minimum [Member]
        
Property, Plant and Equipment [Line Items]        
Estimated useful life of property, plant and equipment 5 years      
Maximum [Member]
        
Property, Plant and Equipment [Line Items]        
Estimated useful life of property, plant and equipment 10 years      
Research and Development [Member]
        
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]        
Stock-based compensation expense 0 13,200    
General and Administrative [Member]
        
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]        
Stock-based compensation expense 5,354 13,200    
Auxilium [Member]
        
Concentration of Credit Risk and Major Customers [Abstract]        
Accounts receivable 1,900,000      
Royalty revenue 2,700,000      
Deferred revenue $ 200,000      
XML 31 R19.htm IDEA: XBRL DOCUMENT v2.4.0.8
NET INCOME (LOSS) PER SHARE (Tables)
 3 Months Ended
Mar. 31, 2014
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
March 31,
 
 
 
2014
  
2013
 
Stock options
  
643,313
   
598,498
 
XML 32 R15.htm IDEA: XBRL DOCUMENT v2.4.0.8
RELATED PARTY TRANSACTIONS
 3 Months Ended
Mar. 31, 2014
RELATED PARTY TRANSACTIONS [Abstract]  
RELATED PARTY TRANSACTIONS
8. RELATED PARTY TRANSACTIONS

Our corporate headquarters are currently located at 35 Wilbur St., Lynbrook, NY 11563.  On November 21, 2013, the Company entered into an Agreement of Lease (the “New Lease”) with 35 Wilbur Street Associates, LLC (“New Landlord”) for the Company’s corporate headquarters located at 35 Wilbur Street, Lynbrook, New York 11563 (the “Premises”). Neither the Company nor its affiliates have a material relationship or affiliation with the New Landlord. As previously reported, the Company formerly leased the Premises from Wilbur St. Corp. (“WSC”). On November 21, 2013, WSC sold the Premises to the New Landlord, and the Company entered into the New Lease with the New Landlord and simultaneously terminated the lease with WSC. The term of the New Lease is twenty-four months, provided, however, that the Company has the option to cancel the New Lease after the first year by giving three months’ notice, which may be given before the expiration of the first year. Pursuant to the New Lease, the Company’s monthly base rent is $12,000. The Company is required to pay as additional rent an amount equal to the increase in taxes over a specified base year.
XML 33 R13.htm IDEA: XBRL DOCUMENT v2.4.0.8
PATENT COSTS
 3 Months Ended
Mar. 31, 2014
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 13 years, and review for impairment on a quarterly basis and when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable.

For the three months ended March 31, 2014, we increased our capitalized patent costs by $151,000 based on the most current information reported to us by Auxilium. As of March 31, 2014, the Company’s estimated capitalized costs related to certain patent costs paid by Auxilium on behalf of the Company are approximately $192,000, which are reimbursable to Auxilium under the Auxilium Agreement.  These patent costs are creditable against future royalty revenues. For each period presented below net patent costs consisted of:

 
 
March 31,
  
December 31,
 
 
 
2014
  
2013
 
Patents
 
$
623,828
  
$
472,375
 
Accumulated Amortization
  
(301,221
)
  
(256,376
)
 
 
$
322,607
  
$
215,999
 

The amortization expense for patents for the three months ended March 31, 2014 was approximately $45,000. In the comparable period of 2013, the amortization expense for patents was approximately $16,000. The estimated aggregate amortization expense for each of the next five years is approximately as follows:

2015
 
$
38,000
 
2016
  
32,000
 
2017
  
32,000
 
2018
  
32,000
 
2019
  
32,000
 
XML 34 R14.htm IDEA: XBRL DOCUMENT v2.4.0.8
PROVISION FOR INCOME TAXES
 3 Months Ended
Mar. 31, 2014
PROVISION FOR INCOME TAXES [Abstract]  
PROVISION FOR INCOME TAXES
7. PROVISION FOR INCOME TAXES

In determining our provision for income taxes, we consider all available information, including operating results, ongoing tax planning, and forecasts of future taxable income. The significant components of the Company's deferred tax assets pursuant to Accounting Standards Codification 740-10-50 consist of stock-based compensation and deferred revenues. For the three month period ended March 31, 2014, the provision for income taxes was $0.4 million.  For the three month period ended March 31, 2014, the valuation allowance with respect to the Company’s net deferred tax assets remained unchanged.  As of March 31, 2014, our remaining deferred tax assets were approximately $1.5 million.

For the three month period ended March 31, 2013, the provision for income taxes was $0.7 million.  For the three month period ended March 31, 2013, the valuation allowance with respect to the Company’s net deferred tax assets remained unchanged.  As of March 31, 2013, our remaining deferred tax assets were approximately $1.6 million.
XML 35 R16.htm IDEA: XBRL DOCUMENT v2.4.0.8
SUBSEQUENT EVENTS
 3 Months Ended
Mar. 31, 2014
SUBSEQUENT EVENTS [Abstract]  
SUBSEQUENT EVENTS
9. SUBSEQUENT EVENTS

We have evaluated subsequent events for recognition or disclosure through the time of filing these consolidated financial statements on Form 10-Q with the SEC on May 9, 2014.
XML 36 R21.htm IDEA: XBRL DOCUMENT v2.4.0.8
PATENT COSTS (Tables)
 3 Months Ended
Mar. 31, 2014
PATENT COSTS [Abstract]  
Net Patent Costs
For each period presented below net patent costs consisted of:

 
 
March 31,
  
December 31,
 
 
 
2014
  
2013
 
Patents
 
$
623,828
  
$
472,375
 
Accumulated Amortization
  
(301,221
)
  
(256,376
)
 
 
$
322,607
  
$
215,999
 
Estimated Aggregate Future Amortization Expense
The amortization expense for patents for the three months ended March 31, 2014 was approximately $45,000. In the comparable period of 2013, the amortization expense for patents was approximately $16,000. The estimated aggregate amortization expense for each of the next five years is approximately as follows:

2015
 
$
38,000
 
2016
  
32,000
 
2017
  
32,000
 
2018
  
32,000
 
2019
  
32,000
 
XML 37 R26.htm IDEA: XBRL DOCUMENT v2.4.0.8
PATENT COSTS (Details) (USD $)
 3 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Dec. 31, 2013
Net Patent Costs [Abstract]      
Net patent costs $ 322,607   $ 215,999
Amortization expense for patents 45,000 16,000  
Estimated amortization expense [Abstract]      
2015 38,000    
2016 32,000    
2017 32,000    
2018 32,000    
2019 32,000    
Patents [Member]
      
Finite-Lived Intangible Assets [Line Items]      
Increase in capitalized patent costs 151,000    
Capitalized patents costs reimbursable to customer 192,000    
Net Patent Costs [Abstract]      
Patents 623,828   472,375
Accumulated Amortization (301,221)   (256,376)
Net patent costs 322,607   215,999
Amortization expense for patents $ 45,000 $ 16,000  
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 13 years    
XML 38 R5.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statements of Comprehensive Income (unaudited) (USD $)
 3 Months Ended
Mar. 31, 2014
Mar. 31, 2013
Consolidated Statements of Comprehensive Income (unaudited) [Abstract]    
Net income $ 753,989 $ 1,353,084
Other comprehensive income (loss) 0 0
Comprehensive income $ 753,989 $ 1,353,084
XML 39 R10.htm IDEA: XBRL DOCUMENT v2.4.0.8
NET INCOME (LOSS) PER SHARE
 3 Months Ended
Mar. 31, 2014
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
March 31,
 
 
 
2014
  
2013
 
Stock options
  
643,313
   
598,498
 
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PROVISION FOR INCOME TAXES (Details) (USD $)
 3 Months Ended
Mar. 31, 2014
Mar. 31, 2013
PROVISION FOR INCOME TAXES [Abstract]    
Net income tax expense (benefit) $ 386,402 $ 719,450
Deferred tax assets $ 1,500,000 $ 1,600,000
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ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables)
 3 Months Ended
Mar. 31, 2014
ACCOUNTS PAYABLE AND ACCRUED EXPENSES [Abstract]  
Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following:

 
 
March 31,
  
December 31,
 
 
 
2014
  
2013
 
Trade accounts payable and accrued expenses
 
$
551,189
  
$
$ 409,617
 
Accrued legal and other professional fees
  
145,531
   
61,538
 
Accrued payroll and related costs
  
180,365
   
163,122
 
 
Total
$
877,085
$
634,277