0001140361-13-031299.txt : 20130809 0001140361-13-031299.hdr.sgml : 20130809 20130809071708 ACCESSION NUMBER: 0001140361-13-031299 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 9 CONFORMED PERIOD OF REPORT: 20130630 FILED AS OF DATE: 20130809 DATE AS OF CHANGE: 20130809 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: 131024421 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 6-30-2013

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

(Mark One)
x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 For the quarterly period ended June 30, 2013

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 August 7, 2013
Common Stock ($.001 par value)
6,339,815


BIOSPECIFICS TECHNOLOGIES CORP.

TABLE OF CONTENTS
 
 
 
 
Page
 
PART I – FINANCIAL INFORMATION
 
ITEM 1.
4
 
4
 
5
 
6
 
7
ITEM 2.
13
ITEM 3.
22
ITEM 4.
22

 
PART II – OTHER INFORMATION
 
ITEM 1.
22
ITEM 1A.
22
ITEM 2.
22
ITEM 3.
23
ITEM 4.
23
ITEM 5.
23
ITEM 6.
23
 
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 include statements concerning, among other things, the timing of reporting top-line data from BioSpecifics’ phase II clinical trial of XIAFLEX for the treatment of human lipoma and its placebo controlled randomized study to evaluate the efficacy of XIAFLEX for the treatment of canine lipoma; and the timing for receiving the final earn-out payments under BioSpecifics’ agreement with DFB Biotech, Inc. and its affiliates.  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, Swedish Orphan Biovitrum AB, Asahi Kasei Pharma Corporation and Actelion Pharmaceuticals Ltd., to achieve their objectives for XIAFLEX in their applicable territories; the market for XIAFLEX in, and initiation and outcome of clinical trials for, additional indications including frozen shoulder, cellulite, human lipoma and canine lipoma, all of which will determine the amount of milestone, royalty and sublicense income BioSpecifics may receive; the potential of XIAFLEX to be used in additional indications; the timing of results of any clinical trials; the receipt of any applicable milestone payments from Auxilium Pharmaceuticals, Inc.; whether royalty payments BioSpecifics is entitled to receive will exceed set-offs; and other risk factors identified in BioSpecifics’ Annual Report on Form 10-K for the year ended December 31, 2012, its Quarterly Report on Form 10-Q for the first quarter of 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 BioSpecifics assumes no obligation to update these forward-looking statements.

PART I – FINANCIAL INFORMATION

Item 1: Consolidated Financial Statements

BioSpecifics Technologies Corp.
Consolidated Balance Sheets

 
 
June 30,
   
December 31,
 
 
 
2013
   
2012
 
 
 
(unaudited)
   
(audited)
 
Assets
 
   
 
Current assets:
 
   
 
Cash and cash equivalents
 
$
4,017,531
   
$
3,383,737
 
Short-term investments
   
7,966,964
     
5,120,000
 
Accounts receivable, net
   
3,903,942
     
5,082,360
 
Income tax receivable
   
51,070
     
51,070
 
Deferred tax assets
   
79,482
     
88,910
 
Prepaid expenses and other current assets
   
411,110
     
149,724
 
Total current assets
   
16,430,099
     
13,875,801
 
 
               
Deferred royalty buy-down
   
2,750,000
     
2,750,000
 
Deferred tax assets - long term
   
1,492,509
     
1,484,141
 
Patent costs, net
   
248,160
     
280,322
 
 
               
Total assets
   
20,920,768
     
18,390,264
 
 
               
Liabilities and Stockholders' Equity
               
Current liabilities:
               
Accounts payable and accrued expenses
   
660,560
     
512,866
 
Deferred tax liability
   
382,704
     
-
 
Deferred revenue
   
78,328
     
133,524
 
Accrued liabilities of discontinued operations
   
78,138
     
78,138
 
Total current liabilities
   
1,199,730
     
724,528
 
 
               
Long-term deferred revenue
   
172,825
     
207,390
 
 
               
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 ; 6,625,168 shares issued at June 30, 2013 and December 31, 2012, respectively
   
6,625
     
6,625
 
Additional paid-in capital
   
20,794,154
     
20,688,706
 
Retained earnings (deficit)
   
2,070,441
     
(310,829
)
Treasury stock, 285,352 and 260,632 shares at cost at June 30, 2013 and December 31, 2012, respectively
   
(3,323,007
)
   
(2,926,156
)
Total stockholders' equity
   
19,548,213
     
17,458,346
 
 
               
Total liabilities and stockholders’ equity
 
$
20,920,768
   
$
18,390,264
 

See accompanying notes to consolidated financial statements
BioSpecifics Technologies Corp.
Consolidated Statements of Operations
(unaudited)
 
 
 
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
 
 
2013
   
2012
   
2013
   
2012
 
Revenues:
 
   
   
   
 
Net sales
 
$
27,500
   
$
1,246
   
$
29,743
   
$
8,750
 
Royalties
   
3,197,603
     
2,491,313
     
6,630,503
     
4,391,282
 
Licensing revenues
   
44,880
     
109,275
     
589,761
     
788,550
 
Total Revenues
   
3,269,983
     
2,601,834
     
7,250,007
     
5,188,582
 
 
                               
Costs and expenses:
                               
Research and development
   
470,044
     
404,346
     
764,918
     
653,898
 
General and administrative
   
1,236,254
     
1,149,926
     
2,854,736
     
2,238,648
 
Total Cost and Expenses
   
1,706,298
     
1,554,272
     
3,619,654
     
2,892,546
 
 
                               
Operating income
   
1,563,685
     
1,047,562
     
3,630,353
     
2,296,036
 
 
                               
Other income (expense):
                               
Interest income
   
6,510
     
9,771
     
12,376
     
19,264
 
 
   
6,510
     
9,771
     
12,376
     
19,264
 
 
                               
Income before expense for income tax
   
1,570,195
     
1,057,333
     
3,642,729
     
2,315,300
 
Income tax benefit (expense)
   
(542,009
)
   
(390,651
)
   
(1,261,459
)
   
(906,228
)
 
                               
Net income
 
$
1,028,186
   
$
666,682
   
$
2,381,270
   
$
1,409,072
 
 
                               
Basic net income per share
 
$
0.16
   
$
0.11
   
$
0.37
   
$
0.22
 
Diluted net income per share
 
$
0.15
   
$
0.10
   
$
0.34
   
$
0.20
 
 
                               
Shares used in computation of basic net income per share
   
6,345,277
     
6,343,356
     
6,351,083
     
6,339,930
 
Shares used in computation of diluted net income per share
   
6,968,057
     
6,971,687
     
6,966,045
     
6,984,258
 
 
Consolidated Statements of Comprehensive Income

(unaudited)

 
 
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
 
 
2013
   
2012
   
2013
   
2012
 
Net income
 
$
1,028,186
   
$
666,682
   
$
2,381,270
   
$
1,409,072
 
Other comprehensive income (loss)
   
-
     
-
     
-
     
-
 
Comprehensive income
 
$
1,028,186
   
$
666,682
   
$
2,381,270
   
$
1,409,072
 

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

 
 
Six Months Ended
June 30,
 
Cash flows from operating activities:
 
2013
   
2012
 
Net income
 
$
2,381,270
   
$
1,409,072
 
Adjustments to reconcile net income to net cash provided
               
By operating activities:
               
Depreciation and amortization
   
32,162
     
29,019
 
Stock-based compensation expense
   
105,449
     
175,685
 
Deferred tax assets
   
1,060
     
416,055
 
Changes in operating assets and liabilities:
               
Accounts receivable
   
1,178,418
     
416,072
 
Prepaid expenses and other current assets
   
(261,387
)
   
72,403
 
Accounts payable and accrued expenses
   
147,694
     
(5,033
)
Accrued taxes payable
   
382,704
     
102,471
 
Deferred revenue
   
(89,761
)
   
(218,550
)
Net cash provided by operating activities
   
3,877,609
     
2,397,194
 
 
               
Cash flows from investing activities:
               
Maturity of marketable investments
   
4,430,000
     
2,000,000
 
Purchases of marketable investments
   
(7,276,964
)
   
(2,000,000
)
Payment for royalty buy down
   
-
     
(1,500,000
)
Net cash used in investing activities
   
(2,846,964
)
   
(1,500,000
)
 
               
Cash flows from financing activities:
               
Proceeds from stock option exercises
   
-
     
78,000
 
Payments for repurchase of common stock
   
(396,851
)
   
(485,904
)
Excess tax benefits from share-based payment arrangements
   
-
     
102,052
 
Net cash used in in financing activities
   
(396,851
)
   
(305,852
)
 
               
Increase in cash and cash equivalents
   
633,794
     
591,342
 
Cash and cash equivalents at beginning of year
   
3,383,737
     
3,196,831
 
Cash and cash equivalents at end of period
 
$
4,017,531
   
$
3,788,173
 
 
               
Supplemental disclosures of cash flow information:
               
Cash paid during the year for:
               
Interest
 
$
-
   
$
-
 
Taxes
 
$
888,500
   
$
92,000
 

Supplemental disclosures of non-cash transactions:
 
Under our agreement with Auxilium certain patent costs paid by Auxilium on behalf of the Company are creditable against future royalties. For the six month period ended June 30, 2013, we accrued approximately $30,000 related to certain patent costs of which we amortized approximately $16,100 in the 2013 period. For the six months ended June 30, 2012, we accrued approximately $64,000 related to these costs of which approximately $29,000 was amortized in the 2012 period.

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

June 30, 2013
(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® (collagenase clostridium histolyticum)) for clinical indications in Dupuytren’s contracture, Peyronie’s disease, frozen shoulder (adhesive capsulitis) and cellulite (edematous fibrosclerotic panniculopathy) (the “Auxilium Agreement”). 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. 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. Auxilium has been granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren’s contracture in adults with a palpable cord in Canada. In July 2013 Auxilium entered into a long-term collaboration with Swedish Orphan Biovitrum AB (“Sobi”) for the development, supply and commercialization of XIAPEX® (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture.  In addition, work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU.

Pursuant to a March 2006 agreement (the “DFB Agreement”) between the Company and DFB Biotech, Inc. (“DFB”), we continue to receive earn-out payments based on the sales of Santyl.  Our right to receive earn-out payments with respect to the marketed topical product sold to DFB expires in August 2013, and we expect to receive our final earn-out payment for Santyl by the end of the year.

Operational Highlights

On July 23, 2013 we presented a poster titled “Biomechanical Evaluation of Human Uterine Fibroids after Exposure to Purified Clostridial Collagenase” at the Society for the Study of Reproduction 46th Annual Meeting in Montreal, Quebec, Canada.  The poster provided data which showed that highly purified collagenase can reduce the stiffness of human uterine fibroid tissue in laboratory experiments. Increased tissue rigidity has been implicated as a cause of the morbidity associated with uterine fibroids. The results of this ex vivo study show that treatment of fibroids with determined doses of purified collagenase caused a statistically significant decrease in the stiffness of the tissue. This hypothesis was tested in fibroid tissue obtained after hysterectomy or myomectomy surgery from patients. Tissues were injected with collagenase and compared to control-injected tissue.

On July 16, 2013, Auxilium announced that it has entered into a long-term collaboration with Sobi for the development, supply and commercialization of XIAPEX (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture.  In addition, Auxilium stated that work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU. Under the terms of the collaboration agreement, Sobi will receive exclusive rights to commercialize XIAPEX for Dupuytren’s contracture and Peyronie’s disease, subject to applicable regulatory approvals, in 28 EU member countries, Switzerland, Norway, Iceland, 18 Central Eastern Europe/Commonwealth of Independent countries, including Russia and Turkey, and 22 Middle Eastern & North African countries.  Since 2011, XIAPEX has been approved for the treatment of Dupuytren's contracture in 28 EU member countries, Switzerland, and Norway.  Sobi, via its Partner Products business unit, will be primarily responsible for the applicable regulatory, clinical and commercialization activities for XIAPEX in Dupuytren's contracture and Peyronie's disease in these countries.

In April 2013, we completed enrollment in our placebo-controlled, randomized Phase II trial, Chien-804, to evaluate the efficacy of XIAFLEX for the treatment of subcutaneous benign lipomas in 32 canines randomized 1:1 XIAFLEX to placebo. The lipoma volume will be measured at baseline, 1 month and 3 months with the primary efficacy endpoint being the relative change in lipoma volume from baseline to 3 months, as determined by CT scan.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
Basis of Presentation

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

The information included in this Report should be read in conjunction with our Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and our Annual Report on Form 10-K for the year ended December 31, 2012 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, U.S. government securities, or short-term commercial paper.

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 June 30, 2013, the accounts receivable balance of $3.9 million was primarily from two customers, comprised of $2.5 million (64% of total) from DFB and $1.4 million (36% of total) from Auxilium.

The Company has been dependent in each year on two customers who generate almost all its revenues. In the quarter ended June 30, 2013, the licensing and royalty revenues from Auxilium were $4.7 million (65% of total) and royalty revenues from DFB were $2.5 million (35% of total).

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 of the cost of goods sold revenues. The royalty and mark-up on cost of goods sold revenues will generally be recognized in the quarter that Auxilium provides the written reports and related information to us, that is, royalty and mark-up on cost of goods sold revenues are generally recognized one quarter following the quarter in which the underlying sales by Auxilium occurred. The royalties payable by Auxilium to us are subject to set-off for certain patent costs.

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

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 U.S. Food and Drug Administration or other regulatory agencies require additional data or information, we would adjust our development period estimates accordingly. The impact on revenue of changes in our estimates and the timing thereof is recognized prospectively over the remaining estimated product development period.
 
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 two large pharmaceutical customers.  These companies have historically paid timely and have been financially stable organizations.  Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.  If the financial condition of our customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required.  We provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after we have used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable.
 
At June 30, 2013, the accounts receivable balance of $3.9 million was primarily from two customers, comprised of $2.5 million from DFB and $1.4 million from Auxilium.
 
Deferred revenue of $0.5 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 in each of the last three years.  The allowance for doubtful accounts balance was approximately $30,000 at June 30, 2013 and 2012.
 
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 June 30, 2013 our net reimbursable third party patent costs accrual was approximately $30,000.

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 payable upon the occurrence of a milestone event.

As of June 30, 2013, we have capitalized $2.75 million related to this agreement which will be amortized over approximately five years beginning on the date of the first commercial sale of XIAFLEX for the treatment of Peyronie’s disease, which represents the period estimated to be benefited using the straight-line method. In accordance with Accounting Standards Codification 350, Intangibles, Goodwill and Other, the Company amortizes intangible assets with finite lives in a manner that reflects the pattern in which the economic benefits of the assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the assets are amortized using the straight-line method.
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. We granted to one of our consultants 15,000 stock options, valued at approximately $79,000, during the three month period ended June 30, 2013. We used the Black-Scholes valuation model to estimate the value of options using 37% volatility, a risk free rate of 0.68% and average exercise period of five years.

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
June 30,
   
Six Months Ended
June 30,
 
 
 
2013
   
2012
   
2013
   
2012
 
Research and development
 
$
79,049
   
$
122,679
   
$
92,249
   
$
144,817
 
General and administrative
   
-
     
13,200
     
13,200
     
30,868
 
Total stock-based compensation expense
 
$
79,049
   
$
135,879
   
$
105,449
   
$
175,685
 

Stock Option Activity

A summary of our stock option activity during the six months ended June 30, 2013 is presented below:

 
 
Total Number
   
Weighted-Average
 
Options
 
of Shares
   
Exercise Price
 
Outstanding as of December 31, 2012
   
1,182,000
   
$
8.90
 
Granted
   
15,000
     
15.85
 
Forfeited
   
-
     
-
 
Exercised
   
-
     
-
 
Expired
   
-
     
-
 
Outstanding as of June 30, 2013
   
1,197,000
   
$
8.99
 
 
Exercisable as of June 30, 2013
1,177,000
$
8.64
 
During the six months ended June 30, 2013 and 2012, zero and $78,000, respectively, were received from stock options exercised by option holders.

The aggregate intrinsic value of options outstanding and exercisable as of June 30, 2013 was approximately $8.2 million. Aggregate intrinsic value represents the total pre-tax intrinsic value based on the closing price of our common stock of $15.60 on June 28, 2013, which would have been received by the option holders had all option holders exercised their options as of that date. We have no unrecognized compensation cost related to stock options outstanding as of June 30, 2013.

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
June 30,
   
Six Months Ended
June 30,
 
 
 
2013
   
2012
   
2013
   
2012
 
Stock options
   
622,780
     
628,331
     
614,962
     
644,328
 

4. COMPREHENSIVE INCOME (LOSS)

For the three and six months ended June 30, 2013 and 2012, we had no components of other comprehensive income or loss other than net income itself.

5. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consisted of the following:

 
 
June 30,
   
December 31,
 
 
 
2013
   
2012
 
Trade accounts payable and accrued expenses
 
$
365,054
   
$
$ 304,635
 
Accrued legal and other professional fees
   
129,822
     
61,147
 
Accrued payroll and related costs
   
165,684
     
147,084
 
                 
Total
 
$
660,560
    $ 512,866  
 
6. PATENT COSTS

We amortize intangible assets with definite lives on a straight-line basis over their estimated useful lives, ranging from 2 to 14 years, and review for impairment on a quarterly basis and when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable.

As of June 30, 2013, the Company’s capitalized costs related to certain patent costs paid by Auxilium on behalf of the Company, 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:

 
 
June 30,
   
December 31,
 
 
 
2013
   
2012
 
Patents
 
$
472,375
   
$
472,375
 
Accumulated Amortization
   
(224,215
)
   
(192,053
)
 
 
$
248,160
   
$
280,322
 

The amortization expense for patents for the six months ended June 30, 2013 was approximately $32,000. In the comparable period of 2012, the amortization expense for patents was approximately $29,000. The estimated aggregate amortization expense for each of the next five years is approximately as follows:

2014
 
$
53,000
 
2015
   
25,000
 
2016
   
20,000
 
2017
   
20,000
 
2018
   
20,000
 

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 six month period ended June 30, 2013, the provision for income taxes was $1.3 million.  For the six month period ended June 30, 2013, the valuation allowance with respect to the Company’s net deferred tax assets remained unchanged.  As of June 30, 2013, our remaining deferred tax assets were approximately $1.5 million.

For the six month period ended June 30, 2012 our provision for income taxes was $0.9 million, primarily a non-cash charge.  For the six month period ended June 30, 2012, the valuation allowance with respect to the company’s net deferred tax assets remained unchanged.  Our remaining deferred tax assets decreased by $0.4 million to approximately $2.6 million, primarily because we used our Orphan Drug Tax Credit to reduce our taxes payable, during six months ended June 30, 2012.

8. RELATED PARTY TRANSACTIONS

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

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 August 9, 2013.

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® (collagenase clostridium histolyticum)) for clinical indications in Dupuytren’s contracture, Peyronie’s disease, frozen shoulder (adhesive capsulitis) and cellulite (edematous fibrosclerotic panniculopathy) (the “Auxilium Agreement”). 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. 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. Auxilium has been granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren’s contracture in adults with a palpable cord in Canada. In July 2013 Auxilium entered into a long-term collaboration with Swedish Orphan Biovitrum AB (“Sobi”) for the development, supply and commercialization of XIAPEX® (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture.  In addition, work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU.

Pursuant to a March 2006 agreement (the “DFB Agreement”) between the Company and DFB Biotech, Inc. (“DFB”), we continue to receive earn-out payments based on the sales of Santyl.  Our right to receive earn-out payments with respect to the marketed topical product sold to DFB expires in August 2013, and we expect to receive our final earn-out payment for Santyl by the end of the year.
Operational Highlights

On July 23, 2013 we, presented a poster titled “Biomechanical Evaluation of Human Uterine Fibroids after Exposure to Purified Clostridial Collagenase” at the Society for the Study of Reproduction 46th Annual Meeting in Montreal, Quebec, Canada.  The poster provided data which showed that highly purified collagenase can reduce the stiffness of human uterine fibroid tissue in laboratory experiments. Increased tissue rigidity has been implicated as a cause of the morbidity associated with uterine fibroids. The results of this ex vivo study show that treatment of fibroids with determined doses of purified collagenase caused a statistically significant decrease in the stiffness of the tissue. This hypothesis was tested in fibroid tissue obtained after hysterectomy or myomectomy surgery from patients. Tissues were injected with collagenase and compared to control-injected tissue.

On July 16, 2013, Auxilium announced that it has entered into a long-term collaboration with Sobi for the development, supply and commercialization of XIAPEX (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture.  In addition, work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU. Under the terms of the collaboration agreement, Sobi will receive exclusive rights to commercialize XIAPEX for Dupuytren’s contracture and Peyronie’s disease, subject to applicable regulatory approvals, in 28 EU member countries, Switzerland, Norway, Iceland, 18 Central Eastern Europe/Commonwealth of Independent countries, including Russia and Turkey, and 22 Middle Eastern & North African countries.  Since 2011, XIAPEX has been approved for the treatment of Dupuytren's contracture in 28 EU member countries, Switzerland, and Norway.  Sobi, via its Partner Products business unit, will be primarily responsible for the applicable regulatory, clinical and commercialization activities for XIAPEX in Dupuytren's contracture and Peyronie's disease in these countries.

In April 2013, we completed enrollment in our placebo-controlled, randomized Phase II trial, Chien-804, to evaluate the efficacy of XIAFLEX for the treatment of subcutaneous benign lipomas in 32 canines randomized 1:1 XIAFLEX to placebo. The lipoma volume will be measured at baseline, 1 month and 3 months with the primary efficacy endpoint being the relative change in lipoma volume from baseline to 3 months, as determined by CT scan.

Outlook

Currently, we generate revenue from two primary sources: in connection with the DFB Agreement and in connection with the Auxilium Agreement.  Under the DFB Agreement, our right to receive earn-out payments with respect to the marketed topical product sold to DFB expires in August 2013, and we expect to receive our final earn-out payment for Santyl by the end of the year.  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, successfully develop XIAFLEX for additional indications, obtain required regulatory approvals, manufacture XIAFLEX at an acceptable cost, in a timely manner and with appropriate quality, or successfully market products or maintain desired margins for products sold, and as a result we may not achieve sustained profitable operations.

Critical Accounting Policies, Estimates and Assumptions

The preparation of unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the unaudited consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. These estimates are based on historical experience and on various other assumptions that we believe are reasonable under the circumstances. The information at June 30, 2013 and for the three and six months ended June 30, 2013 and 2012 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, 2012 balance sheet amounts and disclosures included herein have been derived from the Company’s December 31, 2012 audited consolidated financial statements. The interim results are not necessarily indicative of results to be expected for the full fiscal year. These unaudited consolidated financial statements should be read in conjunction with the unaudited consolidated financial statements for the period ended March 31, 2013 included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 10, 2013 and the audited consolidated financial statements for the year ended December 31, 2012 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 15, 2013. 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 have the right to receive earn-out payments in the future based on sales of certain products.  Generally, under the DFB Agreement we would receive payments and a report within ninety (90) days from the end of each calendar year after DFB has sold the royalty-bearing product. Currently, DFB is providing us earn-out reports on a quarterly basis. We expect to receive the final earn-out payment under the DFB Agreement at the end of 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 June 30, 2013 our net reimbursable third party patent costs accrual was approximately $30,000.

Receivables and Deferred Revenue. Accounts receivable as of June 30, 2013 is approximately $3.9 million, which consists of approximately $2.5 million due from DFB in accordance with the earn-out under the DFB Agreement and approximately $1.4 million in royalties and mark-up on costs of goods sold due from Auxilium in accordance with the terms of the Auxilium Agreement. Deferred revenue of $0.5 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 payable upon the occurrence of a milestone event.

As of June 30, 2013, we have capitalized $2.75 million related to this agreement which will be amortized over approximately five years beginning on the date of the first commercial sale of XIAFLEX for the treatment of Peyronie’s disease, which represents the period estimated to be benefited using the straight-line method. In accordance with Accounting Standards Codification 350, Intangibles, Goodwill and Other, the Company amortizes intangible assets with finite lives in a manner that reflects the pattern in which the economic benefits of the assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the assets are amortized using the straight-line method.

Stock Based Compensation. Under ASC 718, we estimate the fair value of our employee stock awards at the date of grant using the Black-Scholes option-pricing model, which requires the use of certain subjective assumptions. The most significant assumptions are our estimates of the expected volatility of the market price of our stock and the expected term of an award. Expected volatility is based on the historical volatility of our common stock. When establishing an estimate of the expected term of an award, we consider the vesting period for the award, our historical experience of employee stock option exercises (including forfeitures) and the expected volatility. As required under the accounting rules, we review our valuation assumptions at each grant date and, as a result, we are likely to change our valuation assumptions used to value future employee stock-based awards granted, to the extent any such awards are granted.

Further, ASC 718 requires that employee stock-based compensation costs be recognized over the requisite service period, or the vesting period, in a manner similar to all other forms of compensation paid to employees. The allocation of employee stock-based compensation costs to each operating expense line are estimated based on specific employee headcount information at each grant date and estimated stock option forfeiture rates and revised, if necessary, in future periods if actual employee headcount information or forfeitures differ materially from those estimates. As a result, the amount of employee stock-based compensation costs we recognize in each operating expense category in future periods may differ significantly from what we have recorded in the current period.

RESULTS OF OPERATIONS

THREE MONTHS ENDED JUNE 30, 2013 AND 2012

Revenues

Product Revenues, net

Product revenues include the sales of the collagenase for laboratory use recognized at the time it is shipped to customers. We had a small amount of revenue from the sale of collagenase for laboratory use.  For the three months ended June 30, 2013 and 2012 product revenues were $27,500 and $1,246, respectively. This increase was primarily related to the amount of material required to perform testing and additional research by our customers.

Royalties

Royalties consist of royalties and the mark-up on cost of goods sold under the Auxilium Agreement and earn-out revenues associated with the DFB Agreement. Total royalty, mark-up on cost of goods sold and earn-out revenues for the three month period ended June 30, 2013 were $3.2 million as compared to $2.5 million in the 2012 period, an increase of $0.7 million or 28%. Royalty and the mark-up on cost of goods sold revenues recognized under the Auxilium Agreement were $1.7 million for the 2013 period compared to $1.5 million in the 2012 period. The increase of $0.2 million was due to increased net sales of XIAFLEX during 2013 reported to us by Auxilium.
We receive earn-out revenues from DFB under the earn-out payment provision of the DFB Agreement after certain net sales levels are achieved. Revenues recognized under the DFB Agreement were $1.5 million for the three months ended June 30, 2013 as compared to $0.9 million in the 2012 period. The increase of $0.6 million was due to increased net sales of Santyl during 2013 reported to us by DFB. DFB’s Santyl assets were purchased by Smith & Nephew plc at the end of the fourth quarter of 2012.
 
Licensing Revenue
 
Licensing revenue consists of licensing fees, sublicensing fees and milestones. 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 June 30, 2013, we recognized total licensing revenue related to the development of XIAFLEX of approximately $44,881 as compared to $109,275 in the 2012 period.

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 $470,044 and $404,346, respectively, for the three months ended June 30, 2013 and 2012, representing an increase in 2013 of $65,698, or 16%. This increase in research and development expenses was primarily due to expenses related to our clinical development and research programs partially offset by lower stock based compensation expense.

We are currently working to develop XIAFLEX for the treatment of human and canine lipoma. We have initiated a placebo controlled randomized study to evaluate the efficacy of XIAFLEX for the treatment of subcutaneous benign lipomas in canines. The study will consist of 32 canines randomized at 1:1 XIAFLEX or placebo. The treatment is a single injection of XIAFLEX or placebo. The primary efficacy endpoint will be the relative change in lipoma volume from baseline to 3 months, as determined by CT scan. We have completed enrollment for this study, and top-line data is expected in the second half of 2013.

Also, we have initiated a 14-patient, single center dose escalation, phase II clinical trial of XIAFLEX for the treatment of human lipomas. The study is a single injection, open-label trial, and XIAFLEX is being administered in four ascending doses (0.058 mg to 0.44 mg). The primary efficacy endpoint will be a change in the visible surface area of the target lipoma, as determined at six months post-injection. We have completed enrollment for this study, and top-line data is expected in the second half of 2013.
 
The following table summarizes our research and development expenses related to our clinical development programs.
 
 
 
Three Months Ended
June 30, 2013
   
Three Months Ended
June 30, 2012
 
Program
 
   
 
Canine Lipoma
 
$
180,646
   
$
127,510
 
Human Lipoma
 
$
39,184
   
$
74,155
 

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

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

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

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and other related costs for personnel, consultant costs, legal fees, investor relations, professional fees and overhead costs. General and administrative expenses were $1.2 million and $1.1 million for the three months ended June 30, 2013 and 2012, respectively, an increase of approximately $0.1 million, or 8%, from 2012. The increase in general and administrative expenses was due to increased professional fees, investor relations and consulting services.

Other Income and expense

Other income for the three months ended June 30, 2013 was $6,510 compared to $9,771 in the 2012 period. Other income in both periods consisted 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 June 30, 2013 our provision for income taxes was $0.5 million. The provision for income taxes for the three month period ended June 30, 2013 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 June 30, 2013, the valuation allowance with respect to our net deferred tax assets remained unchanged.  As of June 30, 2013, our remaining deferred tax assets were approximately $1.5 million.

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

Net Income
 
For the three months ended June 30, 2013 we recorded net income of $1.0 million, or $0.16 per basic common share and $0.15 per diluted common share, compared to a net income of $0.7 million, or $0.11 per basic and $0.10 per diluted common share, for the same period in 2012.

SIX MONTHS ENDED JUNE 30, 2013 AND 2012

Revenues

Product Revenues, net

Product revenues include the sales of the collagenase for laboratory use recognized at the time it is shipped to customers. We had a small amount of revenue from the sale of collagenase for laboratory use.  For the six months ended June 30, 2013 and 2012 product revenues were $29,743 and $8,750, respectively. This increase was primarily related to the amount of material required to perform testing and additional research by our customers.

Royalties

Royalties consist of royalties and the mark-up on cost of goods sold under the Auxilium Agreement and earn-out revenues associated with the DFB Agreement. Total royalty, mark-up on cost of goods sold and earn-out revenues for the six month period ended June 30, 2013 were $6.6 million as compared to $4.4 million in the 2012 period, an increase of $2.2 million or 51%. Royalty and the mark-up on cost of goods sold revenues recognized under the Auxilium Agreement were $4.1 million for the 2013 period compared to $3.1 million in the 2012 period. The increase of $1.0 million was due to increased net sales of XIAFLEX during 2013 reported to us by Auxilium.
 
We receive earn-out revenues from DFB under the earn-out payment provision of the DFB Agreement after certain net sales levels are achieved. Revenues recognized under the DFB Agreement were $2.5 million for the six months ended June 30, 2013 as compared to $1.3 in the 2012 period. The increase of $1.2 million was due to increased net sales of Santyl during 2013 reported to us by DFB. DFB’s Santyl assets were purchased by Smith & Nephew plc at the end of the fourth quarter of 2012.
 
Licensing Revenue
 
Licensing revenue consists of licensing fees, sublicensing fees and milestones. 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 six months ended June 30, 2013, we recognized total licensing revenue of approximately $0.6 million as compared to $0.8 million in the 2012 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. License fees recognized related to development were $88,761 as compared to $218,550 in the comparable period of 2012. Sublicensing fees recognized in 2013 were zero and $570,000 in the comparable period of 2012. In the 2012 period, sublicensing fees recognized were related to the $10.0 million paid to Auxilium by Actelion for the rights to develop and commercialize XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico.

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 $764,918 and $653,898, respectively, for the six months ended June 30, 2013 and 2012, representing an increase in 2013 of $111,020, or 17%. This increase in research and development expenses was primarily due to expenses related to our clinical development and research programs partially offset by lower stock based compensation expense.
We are currently working to develop XIAFLEX for the treatment of human and canine lipoma. We have initiated a placebo controlled randomized study to evaluate the efficacy of XIAFLEX for the treatment of subcutaneous benign lipomas in canines. The study will consist of 32 canines randomized at 1:1 XIAFLEX or placebo. The treatment is a single injection of XIAFLEX or placebo. The primary efficacy endpoint will be the relative change in lipoma volume from baseline to 3 months, as determined by CT scan. We have completed enrollment for this study, and top-line data is expected in the second half of 2013.

Also, we have initiated a 14-patient, single center dose escalation, phase II clinical trial of XIAFLEX for the treatment of human lipomas. The study is a single injection, open-label trial, and XIAFLEX is being administered in four ascending doses (0.058 mg to 0.44 mg). The primary efficacy endpoint will be a change in the visible surface area of the target lipoma, as determined at six months post-injection. We have completed enrollment for this study, and top-line data is expected in the second half of 2013.
 
The following table summarizes our research and development expenses related to our clinical development programs.
 
 
 
Six Months Ended
June 30, 2013
   
Six Months Ended
June 30, 2012
   
Accumulated Expenses
Since January 1, 2010
 
Program
 
   
   
 
Canine Lipoma
 
$
270,717
   
$
209,801
   
$
1,243,705
 
Human Lipoma
 
$
83,021
   
$
102,433
   
$
487,890
 

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

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

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

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

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and other related costs for personnel, consultant costs, legal fees, investor relations, professional fees and overhead costs. General and administrative expenses were $2.9 million and $2.2 million for the six months ended June 30, 2013 and 2012, respectively, an increase of approximately $0.7 million, or 28%, from 2012. The increase in general and administrative expenses was due to increased third party licensing and royalty fees, investor relations, legal fees, consulting services and professional fees.
Other Income and expense

Other income for the six months ended June 30, 2013 was $12,376 compared to $19,264 in the 2012 period. Other income in both periods consisted 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 six month period ended June 30, 2013 our provision for income taxes was $1.3 million. The provision for income taxes for the six month period ended June 30, 2013 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 six month period ended June 30, 2013, the valuation allowance with respect to our net deferred tax assets remained unchanged.  As of June 30, 2013, our remaining deferred tax assets were approximately $1.5 million.

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

Net Income

For the six months ended June 30, 2013 we recorded net income of $2.4 million, or $0.37 per basic common share and $0.34 per diluted common share, compared to a net income of $1.4 million, or $0.22 per basic and $0.20 per diluted common share, for the same period in 2012.

Liquidity and Capital Resources

To date, we have financed our operations primarily through product sales, debt instruments, licensing revenues and royalties under agreements with third parties and sales of our common stock. At June 30, 2013 and December 31, 2012, we had cash and cash equivalents and investments in the aggregate of approximately $12.0 million and $8.5 million, respectively.

Net cash provided by operating activities for the six months ended June 30, 2013 was $3.9 million as compared to $2.4 million for the same period in 2012. 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. Cash provided by operations in the 2012 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 sublicensing fees, royalties and mark-up on cost goods sold revenues under the Auxilium Agreement.

Net cash used in investing activities for the six months ended June 30, 2013 was $2.8 million as compared to $1.5 million for the 2012 period. The net cash used in investing activities in the 2013 reflects the maturing of $4.4 million and reinvestment of $ 7.3 million in marketable securities. The net cash used in investing activities in the 2012 reflects the maturing and reinvestment of $2.0 million in marketable securities and a one-time cash payment related to our future royalty obligations for Peyronie's disease of $1.5 million.
Net cash used in financing activities for the six months ended June 30, 2013 was $0.4 million as compared $0.3 million in the compared period of 2012. 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. In 2012, net cash used in financing activities was mainly due to the repurchase of our common stock under our stock repurchase program during the period partially offset by excess tax benefits related to share-based payments and proceeds received from stock option exercises.

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 June 30, 2013, amounting to approximately $11.9 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, 2012.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

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

Changes in Internal Controls

There were no changes in our internal controls over financial reporting during the six month period ended June 30, 2013 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 15, 2013.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
 
During the six month period ended June 30, 2013, 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
 
 
       
 
         
$
1,672,146
 
January 1, 2013 – January 31, 2013
   
6,271
   
$
15.15
     
135,636
   
$
1,577,114
 
February 1, 2013 – February 28, 2013
   
3,615
   
$
15.83
     
139,251
   
$
1,519,874
 
March 1, 2013 – March 31, 2013
   
3,206
   
$
16.74
     
142,457
   
$
1,466,196
 
April 1, 2013 – April 30, 2013
   
4,081
   
$
17.08
     
146,538
   
$
1,396,488
 
May 1, 2013 – May 31, 2013
   
4,320
   
$
15.94
     
150,858
   
$
1,327,616
 
June 1, 2013 – June 30, 2013
   
3,227
   
$
16.21
     
154,085
   
$
1,275,294
 

(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.

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 (incorporated by reference to Exhibit 3.2 of the Registrant’s Form 10-KSB filed with the Commission on March 2, 2007)
 
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule13a-14(a)/15d-14(a).
 
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of Sarbanes-Oxley Act of 2002.
 

* filed herewith
SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.

 
BIOSPECIFICS TECHNOLOGIES CORP.
 
(Registrant)
 
Date: August 9, 2013
/s/ Thomas L. Wegman
 
Thomas L. Wegman
 
President, Principal Executive Officer and
Principal Financial Officer
 
 
25

EX-32 2 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, 2013 (the “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934; and

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

IN WITNESS WHEREOF, the undersigned has executed this certification this 9th day of August, 2013.

/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.
 
 


EX-31 3 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 June 30, 2013 of BioSpecifics Technologies Corp.;

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

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

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

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

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

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

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

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

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

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

Date: August 9, 2013

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

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COMPREHENSIVE INCOME (LOSS)</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">For the three and six months ended <font style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">June 30, 2013 </font>and 2012, we had no components of other comprehensive income or loss other than net income itself.</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;">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. 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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 style="line-height: 1; font-size: smaller; vertical-align: text-top;">&#174;</sup> (collagenase clostridium histolyticum)) for clinical indications in Dupuytren&#8217;s contracture, Peyronie&#8217;s disease, frozen shoulder (<font style="font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">adhesive capsulitis</font>) and cellulite (<font style="font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">edematous fibrosclerotic panniculopathy</font>) (the &#8220;Auxilium Agreement&#8221;). 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. 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. Auxilium has been granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren&#8217;s contracture in adults with a palpable cord in Canada. In July 2013 Auxilium entered into a long-term collaboration with Swedish Orphan Biovitrum AB (&#8220;Sobi&#8221;) for the development, supply and commercialization of XIAPEX<sup style="line-height: 1; font-size: smaller; vertical-align: text-top;">&#174;</sup> (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture. &#160;In addition, work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Pursuant to a March 2006 agreement (the &#8220;DFB Agreement&#8221;) between the Company and DFB Biotech, Inc. (&#8220;DFB&#8221;), we continue to receive earn-out payments based on the sales of Santyl. &#160;Our right to receive earn-out payments with respect to the marketed topical product sold to DFB expires in August 2013, and we expect to receive our final earn-out payment for Santyl by the end of the year.</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 July 23, 2013 we presented a poster titled &#8220;Biomechanical Evaluation of Human Uterine Fibroids after Exposure to Purified Clostridial Collagenase&#8221; at the Society for the Study of Reproduction 46<sup style="line-height: 1; font-size: smaller; vertical-align: text-top;">th</sup> Annual Meeting in Montreal, Quebec, Canada. &#160;The poster provided data which showed that highly purified collagenase can reduce the stiffness of human uterine fibroid tissue in laboratory experiments. Increased tissue rigidity has been implicated as a cause of the morbidity associated with uterine fibroids. The results of this <font style="font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">ex vivo</font> study show that treatment of fibroids with determined doses of purified collagenase caused a statistically significant decrease in the stiffness of the tissue. This hypothesis was tested in fibroid tissue obtained after hysterectomy or myomectomy surgery from patients. Tissues were injected with collagenase and compared to control-injected tissue.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">On July 16, 2013, Auxilium announced that it has entered into a long-term collaboration with Sobi for the development, supply and commercialization of XIAPEX (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture. &#160;In addition, Auxilium stated that work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU. Under the terms of the collaboration agreement, Sobi will receive exclusive rights to commercialize XIAPEX for Dupuytren&#8217;s contracture and Peyronie&#8217;s disease, subject to applicable regulatory approvals, in 28 EU member countries, Switzerland, Norway, Iceland, 18 Central Eastern Europe/Commonwealth of Independent countries, including Russia and Turkey, and 22 Middle Eastern &amp; North African countries. &#160;Since 2011, XIAPEX has been approved for the treatment of Dupuytren's contracture in 28 EU member countries, Switzerland, and Norway. &#160;Sobi, via its Partner Products business unit, will be primarily responsible for the applicable regulatory, clinical and commercialization activities for XIAPEX in Dupuytren's contracture and Peyronie's disease in these countries.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">In April 2013, we completed enrollment in our placebo-controlled, randomized Phase II trial, Chien-804, to evaluate the efficacy of XIAFLEX for the treatment of subcutaneous benign lipomas in 32 canines randomized 1:1 XIAFLEX to placebo. 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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 of the cost of goods sold revenues. 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Accounting Standards Codification 718, <font style="font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Compensation - Stock Compensation </font>(&#8220;ASC 718&#8221;), requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based awards including stock options and common stock issued to our employees and directors under our stock plans. It requires companies to estimate the fair value of share-based awards on the date of grant using an option-pricing model. 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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">&#160;</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;"><font style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The information included in this Report should be read in conjunction with our </font>Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and our <font style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Annual Report on Form 10-K for the year ended December 31, 2012 filed with the SEC.</font></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: left; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">&#160;</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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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 of the cost of goods sold revenues. 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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 U.S. Food and Drug Administration or other regulatory agencies require additional data or information, we would adjust our development period estimates accordingly. 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In the event of early termination of a clinical trial, we accrue an amount based on our estimate of the remaining non-cancelable obligations associated with the winding down of the clinical trial. Our estimates and assumptions could differ significantly from the amounts that may actually be incurred.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">Stock-Based Compensation</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The Company has two stock-based compensation plans in effect. 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Treasury Stock [Policy Text Block] Treasury Stock 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 This line item represents one of the major pharmaceutical customer of the entity from which a large part of revenue is generated. Auxilium [Member] Carrying value as of the balance sheet date of obligations incurred through that date and payable for patents. 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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 style="line-height: 1; font-size: smaller; vertical-align: text-top;">&#174;</sup> (collagenase clostridium histolyticum)) for clinical indications in Dupuytren&#8217;s contracture, Peyronie&#8217;s disease, frozen shoulder (<font style="font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">adhesive capsulitis</font>) and cellulite (<font style="font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">edematous fibrosclerotic panniculopathy</font>) (the &#8220;Auxilium Agreement&#8221;). 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. 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. Auxilium has been granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren&#8217;s contracture in adults with a palpable cord in Canada. In July 2013 Auxilium entered into a long-term collaboration with Swedish Orphan Biovitrum AB (&#8220;Sobi&#8221;) for the development, supply and commercialization of XIAPEX<sup style="line-height: 1; font-size: smaller; vertical-align: text-top;">&#174;</sup> (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture. &#160;In addition, work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Pursuant to a March 2006 agreement (the &#8220;DFB Agreement&#8221;) between the Company and DFB Biotech, Inc. (&#8220;DFB&#8221;), we continue to receive earn-out payments based on the sales of Santyl. &#160;Our right to receive earn-out payments with respect to the marketed topical product sold to DFB expires in August 2013, and we expect to receive our final earn-out payment for Santyl by the end of the year.</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 July 23, 2013 we presented a poster titled &#8220;Biomechanical Evaluation of Human Uterine Fibroids after Exposure to Purified Clostridial Collagenase&#8221; at the Society for the Study of Reproduction 46<sup style="line-height: 1; font-size: smaller; vertical-align: text-top;">th</sup> Annual Meeting in Montreal, Quebec, Canada. &#160;The poster provided data which showed that highly purified collagenase can reduce the stiffness of human uterine fibroid tissue in laboratory experiments. Increased tissue rigidity has been implicated as a cause of the morbidity associated with uterine fibroids. The results of this <font style="font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">ex vivo</font> study show that treatment of fibroids with determined doses of purified collagenase caused a statistically significant decrease in the stiffness of the tissue. This hypothesis was tested in fibroid tissue obtained after hysterectomy or myomectomy surgery from patients. Tissues were injected with collagenase and compared to control-injected tissue.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">On July 16, 2013, Auxilium announced that it has entered into a long-term collaboration with Sobi for the development, supply and commercialization of XIAPEX (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture. &#160;In addition, Auxilium stated that work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU. Under the terms of the collaboration agreement, Sobi will receive exclusive rights to commercialize XIAPEX for Dupuytren&#8217;s contracture and Peyronie&#8217;s disease, subject to applicable regulatory approvals, in 28 EU member countries, Switzerland, Norway, Iceland, 18 Central Eastern Europe/Commonwealth of Independent countries, including Russia and Turkey, and 22 Middle Eastern &amp; North African countries. &#160;Since 2011, XIAPEX has been approved for the treatment of Dupuytren's contracture in 28 EU member countries, Switzerland, and Norway. &#160;Sobi, via its Partner Products business unit, will be primarily responsible for the applicable regulatory, clinical and commercialization activities for XIAPEX in Dupuytren's contracture and Peyronie's disease in these countries.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">In April 2013, we completed enrollment in our placebo-controlled, randomized Phase II trial, Chien-804, to evaluate the efficacy of XIAFLEX for the treatment of subcutaneous benign lipomas in 32 canines randomized 1:1 XIAFLEX to placebo. 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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
6 Months Ended
Jun. 30, 2013
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
Basis of Presentation
Basis of Presentation

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

The information included in this Report should be read in conjunction with our Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and our Annual Report on Form 10-K for the year ended December 31, 2012 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, U.S. government securities, or short-term commercial paper.
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 June 30, 2013, the accounts receivable balance of $3.9 million was primarily from two customers, comprised of $2.5 million (64% of total) from DFB and $1.4 million (36% of total) from Auxilium.

The Company has been dependent in each year on two customers who generate almost all its revenues. In the quarter ended June 30, 2013, the licensing and royalty revenues from Auxilium were $4.7 million (65% of total) and royalty revenues from DFB were $2.5 million (35% of total).
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 of the cost of goods sold revenues. The royalty and mark-up on cost of goods sold revenues will generally be recognized in the quarter that Auxilium provides the written reports and related information to us, that is, royalty and mark-up on cost of goods sold revenues are generally recognized one quarter following the quarter in which the underlying sales by Auxilium occurred. The royalties payable by Auxilium to us are subject to set-off for certain patent costs.

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

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 U.S. Food and Drug Administration or other regulatory agencies require additional data or information, we would adjust our development period estimates accordingly. The impact on revenue of changes in our estimates and the timing thereof is recognized prospectively over the remaining estimated product development period.
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 two large pharmaceutical customers.  These companies have historically paid timely and have been financially stable organizations.  Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.  If the financial condition of our customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required.  We provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after we have used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable.
 
At June 30, 2013, the accounts receivable balance of $3.9 million was primarily from two customers, comprised of $2.5 million from DFB and $1.4 million from Auxilium.
 
Deferred revenue of $0.5 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 in each of the last three years.  The allowance for doubtful accounts balance was approximately $30,000 at June 30, 2013 and 2012.
Reimbursable Third Party Development Costs
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 June 30, 2013 our net reimbursable third party patent costs accrual was approximately $30,000.
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 payable upon the occurrence of a milestone event.

As of June 30, 2013, we have capitalized $2.75 million related to this agreement which will be amortized over approximately five years beginning on the date of the first commercial sale of XIAFLEX for the treatment of Peyronie’s disease, which represents the period estimated to be benefited using the straight-line method. In accordance with Accounting Standards Codification 350, Intangibles, Goodwill and Other, the Company amortizes intangible assets with finite lives in a manner that reflects the pattern in which the economic benefits of the assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the assets are amortized using the straight-line method.
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. We granted to one of our consultants 15,000 stock options, valued at approximately $79,000, during the three month period ended June 30, 2013. We used the Black-Scholes valuation model to estimate the value of options using 37% volatility, a risk free rate of 0.68% and average exercise period of five years.

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
June 30,
  
Six Months Ended
June 30,
 
 
 
2013
  
2012
  
2013
  
2012
 
Research and development
 
$
79,049
  
$
122,679
  
$
92,249
  
$
144,817
 
General and administrative
  
-
   
13,200
   
13,200
   
30,868
 
Total stock-based compensation expense
 
$
79,049
  
$
135,879
  
$
105,449
  
$
175,685
 

Stock Option Activity

A summary of our stock option activity during the six months ended June 30, 2013 is presented below:

 
 
Total Number
  
Weighted-Average
 
Options
 
of Shares
  
Exercise Price
 
Outstanding as of December 31, 2012
  
1,182,000
  
$
8.90
 
Granted
  
15,000
   
15.85
 
Forfeited
  
-
   
-
 
Exercised
  
-
   
-
 
Expired
  
-
   
-
 
Outstanding as of June 30, 2013
  
1,197,000
  
$
8.99
 
 
Exercisable as of June 30, 2013
1,177,000
$
8.64
 
During the six months ended June 30, 2013 and 2012, zero and $78,000, respectively, were received from stock options exercised by option holders.

The aggregate intrinsic value of options outstanding and exercisable as of June 30, 2013 was approximately $8.2 million. Aggregate intrinsic value represents the total pre-tax intrinsic value based on the closing price of our common stock of $15.60 on June 28, 2013, which would have been received by the option holders had all option holders exercised their options as of that date. We have no unrecognized compensation cost related to stock options outstanding as of June 30, 2013.
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 13 R4.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statements of Operations (unaudited) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2013
Jun. 30, 2012
Jun. 30, 2013
Jun. 30, 2012
Revenues:        
Net sales $ 27,500 $ 1,246 $ 29,743 $ 8,750
Royalties 3,197,603 2,491,313 6,630,503 4,391,282
Licensing revenues 44,880 109,275 589,761 788,550
Total Revenues 3,269,983 2,601,834 7,250,007 5,188,582
Costs and expenses:        
Research and development 470,044 404,346 764,918 653,898
General and administrative 1,236,254 1,149,926 2,854,736 2,238,648
Total Cost and Expenses 1,706,298 1,554,272 3,619,654 2,892,546
Operating income 1,563,685 1,047,562 3,630,353 2,296,036
Other income (expense):        
Interest income 6,510 9,771 12,376 19,264
Total other income 6,510 9,771 12,376 19,264
Income before expense for income tax 1,570,195 1,057,333 3,642,729 2,315,300
Income tax benefit (expense) (542,009) (390,651) (1,261,459) (906,228)
Net income $ 1,028,186 $ 666,682 $ 2,381,270 $ 1,409,072
Basic net income per share (in dollars per share) $ 0.16 $ 0.11 $ 0.37 $ 0.22
Diluted net income per share (in dollars per share) $ 0.15 $ 0.10 $ 0.34 $ 0.20
Shares used in computation of basic net income per share (in shares) 6,345,277 6,343,356 6,351,083 6,339,930
Shares used in computation of diluted net income per share (in shares) 6,968,057 6,971,687 6,966,045 6,984,258
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NET INCOME (LOSS) PER SHARE
6 Months Ended
Jun. 30, 2013
NET INCOME (LOSS) PER SHARE [Abstract]  
NET INCOME (LOSS) PER SHARE
3. NET INCOME (LOSS) PER SHARE
 
In accordance with Accounting Standards Codification 260, Earnings Per Share, basic net income (loss) per share amount is computed using the weighted-average number of shares of common stock outstanding during the periods presented, while diluted net income (loss) per share is computed using the sum of the weighted-average number of common and common equivalent shares outstanding. Common equivalent shares used in the computation of diluted earnings per share result from the assumed exercise of stock options using the converted method.

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

 
 
Three Months Ended
June 30,
  
Six Months Ended
June 30,
 
 
 
2013
  
2012
  
2013
  
2012
 
Stock options
  
622,780
   
628,331
   
614,962
   
644,328
 
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NET INCOME (LOSS) PER SHARE (Details)
3 Months Ended 6 Months Ended
Jun. 30, 2013
Jun. 30, 2012
Jun. 30, 2013
Jun. 30, 2012
Number of common equivalent shares included for the calculation of diluted net income [Abstract]        
Stock options (in shares) 622,780 628,331 614,962 644,328
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
6 Months Ended
Jun. 30, 2013
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
Stock-Based Compensation Expense
Stock-based compensation expense recognized under ASC 718 was as follows:
 
 
 
Three Months Ended
June 30,
  
Six Months Ended
June 30,
 
 
 
2013
  
2012
  
2013
  
2012
 
Research and development
 
$
79,049
  
$
122,679
  
$
92,249
  
$
144,817
 
General and administrative
  
-
   
13,200
   
13,200
   
30,868
 
Total stock-based compensation expense
 
$
79,049
  
$
135,879
  
$
105,449
  
$
175,685
 
Summary of Stock Option Activity
A summary of our stock option activity during the six months ended June 30, 2013 is presented below:

 
 
Total Number
  
Weighted-Average
 
Options
 
of Shares
  
Exercise Price
 
Outstanding as of December 31, 2012
  
1,182,000
  
$
8.90
 
Granted
  
15,000
   
15.85
 
Forfeited
  
-
   
-
 
Exercised
  
-
   
-
 
Expired
  
-
   
-
 
Outstanding as of June 30, 2013
  
1,197,000
  
$
8.99
 
 
Exercisable as of June 30, 2013
1,177,000
$
8.64
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PROVISION FOR INCOME TAXES (Details) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2013
Jun. 30, 2012
Jun. 30, 2013
Jun. 30, 2012
PROVISION FOR INCOME TAXES [Abstract]        
Net income tax expense (benefit) $ 542,009 $ 390,651 $ 1,261,459 $ 906,228
Decrease in deferred tax assets     1,060 416,055
Deferred tax assets $ 1,500,000 $ 2,600,000 $ 1,500,000 $ 2,600,000
XML 21 R26.htm IDEA: XBRL DOCUMENT v2.4.0.8
PATENT COSTS (Details) (USD $)
3 Months Ended 6 Months Ended 6 Months Ended
Jun. 30, 2013
Jun. 30, 2012
Dec. 31, 2012
Jun. 30, 2013
Patents [Member]
Jun. 30, 2012
Patents [Member]
Dec. 31, 2012
Patents [Member]
Jun. 30, 2013
Patents [Member]
Minimum [Member]
Jun. 30, 2013
Patents [Member]
Maximum [Member]
Finite-Lived Intangible Assets [Line Items]                
Estimated useful lives             2 years 14 years
Net Patent Costs [Abstract]                
Patents       $ 472,375   $ 472,375    
Accumulated Amortization       (224,215)   (192,053)    
Net patent costs 248,160   280,322 248,160   280,322    
Amortization expense for patents 16,100 29,000   32,000 29,000      
Estimated amortization expense [Abstract]                
2014 53,000              
2015 25,000              
2016 20,000              
2017 20,000              
2018 $ 20,000              
XML 22 R19.xml IDEA: NET INCOME (LOSS) PER SHARE (Tables) 2.4.0.8080300 - Disclosure - NET INCOME (LOSS) PER SHARE (Tables)truefalsefalse1false falsefalsec20130101to20130630http://www.sec.gov/CIK0000875622duration2013-01-01T00:00:002013-06-30T00:00:001true 1us-gaap_EarningsPerShareAbstractus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalse1falsefalsefalse00falsefalsefalsexbrli:stringItemTypestringfalse02false 2us-gaap_ScheduleOfWeightedAverageNumberOfSharesTableTextBlockus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalseterseLabel1falsefalsefalse00<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;">The following table summarizes the number of common equivalent shares that were included for the calculation of diluted net income purposes from continuing operations reported in the consolidated statement of operations.</div><div><br /></div><table align="center" border="0" cellpadding="0" cellspacing="0" style="width: 80%; 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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">&#160;</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;"><font style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The information included in this Report should be read in conjunction with our </font>Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and our <font style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Annual Report on Form 10-K for the year ended December 31, 2012 filed with the SEC.</font></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: left; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">&#160;</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, U.S. government securities, or short-term commercial paper.</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. 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In the quarter ended June 30, 2013, the licensing and royalty revenues from Auxilium were $4.7 million (65% of total) and royalty revenues from DFB were $2.5 million (35% of total).</div><div><br /></div><div style="text-align: left; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">Revenue Recognition</div><div style="text-align: left; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">&#160;</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">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, <font style="font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Revenue Recognition</font> (&#8220;ASC 605&#8221;).</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">&#160;</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">If we determine that separate elements exist in a revenue arrangement under ASC 605, we recognize revenue for delivered elements only when the fair values of undelivered elements are known, when the associated earnings process is complete, when payment is reasonably assured and, to the extent the milestone amount relates to our performance obligation, when our customer confirms that we have met the requirements under the terms of the agreement.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Revenues, and their respective treatment for financial reporting purposes, are as follows:</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">Product Sales</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">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. 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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 of the cost of goods sold revenues. The royalty and mark-up on cost of goods sold revenues will generally be recognized in the quarter that Auxilium provides the written reports and related information to us, that is, royalty and mark-up on cost of goods sold revenues are generally recognized one quarter following the quarter in which the underlying sales by Auxilium occurred.<font style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">&#160;</font>The royalties payable by Auxilium to us are subject to set-off for certain patent costs.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Under the DFB Agreement, pursuant to which we sold our topical collagenase business to DFB, we have the right to receive earn-out payments in the future based on sales of certain products. &#160;Generally, under the DFB Agreement we would receive payments and a report within ninety (90) days from the end of each calendar year after DFB has sold the royalty-bearing product.</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;">Licensing Revenue</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">We include revenue recognized from upfront licensing, sublicensing and milestone payments in &#8220;License Revenues&#8221; in our consolidated statements of operations in this Report.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Upfront License and Sublicensing Fees</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">We generally recognize revenue from upfront licensing and sublicensing fees when the agreement is signed, we have completed the earnings process and we have no ongoing performance obligation with respect to the arrangement. 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Accounting Standards Codification 718, <font style="font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Compensation - Stock Compensation </font>(&#8220;ASC 718&#8221;), requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based awards including stock options and common stock issued to our employees and directors under our stock plans. It requires companies to estimate the fair value of share-based awards on the date of grant using an option-pricing model. 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ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) (USD $)
Jun. 30, 2013
Dec. 31, 2012
Accounts payable and accrued expenses [Abstract]    
Trade accounts payable and accrued expenses $ 365,054 $ 304,635
Accrued legal and other professional fees 129,822 61,147
Accrued payroll and related costs 165,684 147,084
Total $ 660,560 $ 512,866
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Consolidated Statements of Cash Flows (unaudited) (USD $)
6 Months Ended
Jun. 30, 2013
Jun. 30, 2012
Cash flows from operating activities:    
Net income $ 2,381,270 $ 1,409,072
Adjustments to reconcile net income to net cash provided By operating activities:    
Depreciation and amortization 32,162 29,019
Stock-based compensation expense 105,449 175,685
Deferred tax assets 1,060 416,055
Changes in operating assets and liabilities:    
Accounts receivable 1,178,418 416,072
Prepaid expenses and other current assets (261,387) 72,403
Accounts payable and accrued expenses 147,694 (5,033)
Accrued taxes payable 382,704 102,471
Deferred revenue (89,761) (218,550)
Net cash provided by operating activities 3,877,609 2,397,194
Cash flows from investing activities:    
Maturity of marketable investments 4,430,000 2,000,000
Purchases of marketable investments (7,276,964) (2,000,000)
Payment for royalty buy down 0 (1,500,000)
Net cash used in investing activities (2,846,964) (1,500,000)
Cash flows from financing activities:    
Proceeds from stock option exercises 0 78,000
Payments for repurchase of common stock (396,851) (485,904)
Excess tax benefits from share-based payment arrangements 0 102,052
Net cash used in financing activities (396,851) (305,852)
Increase in cash and cash equivalents 633,794 591,342
Cash and cash equivalents at beginning of year 3,383,737 3,196,831
Cash and cash equivalents at end of period 4,017,531 3,788,173
Cash paid during the year for:    
Interest 0 0
Taxes $ 888,500 $ 92,000
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ORGANIZATION AND DESCRIPTION OF BUSINESS
6 Months Ended
Jun. 30, 2013
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® (collagenase clostridium histolyticum)) for clinical indications in Dupuytren’s contracture, Peyronie’s disease, frozen shoulder (adhesive capsulitis) and cellulite (edematous fibrosclerotic panniculopathy) (the “Auxilium Agreement”). 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. 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. Auxilium has been granted a Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren’s contracture in adults with a palpable cord in Canada. In July 2013 Auxilium entered into a long-term collaboration with Swedish Orphan Biovitrum AB (“Sobi”) for the development, supply and commercialization of XIAPEX® (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture.  In addition, work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU.

Pursuant to a March 2006 agreement (the “DFB Agreement”) between the Company and DFB Biotech, Inc. (“DFB”), we continue to receive earn-out payments based on the sales of Santyl.  Our right to receive earn-out payments with respect to the marketed topical product sold to DFB expires in August 2013, and we expect to receive our final earn-out payment for Santyl by the end of the year.

Operational Highlights

On July 23, 2013 we presented a poster titled “Biomechanical Evaluation of Human Uterine Fibroids after Exposure to Purified Clostridial Collagenase” at the Society for the Study of Reproduction 46th Annual Meeting in Montreal, Quebec, Canada.  The poster provided data which showed that highly purified collagenase can reduce the stiffness of human uterine fibroid tissue in laboratory experiments. Increased tissue rigidity has been implicated as a cause of the morbidity associated with uterine fibroids. The results of this ex vivo study show that treatment of fibroids with determined doses of purified collagenase caused a statistically significant decrease in the stiffness of the tissue. This hypothesis was tested in fibroid tissue obtained after hysterectomy or myomectomy surgery from patients. Tissues were injected with collagenase and compared to control-injected tissue.

On July 16, 2013, Auxilium announced that it has entered into a long-term collaboration with Sobi for the development, supply and commercialization of XIAPEX (collagenase clostridium histolyticum) for the treatment of Dupuytren's contracture.  In addition, Auxilium stated that work is on-going to file for approval of XIAPEX for the treatment of Peyronie's disease in the EU. Under the terms of the collaboration agreement, Sobi will receive exclusive rights to commercialize XIAPEX for Dupuytren’s contracture and Peyronie’s disease, subject to applicable regulatory approvals, in 28 EU member countries, Switzerland, Norway, Iceland, 18 Central Eastern Europe/Commonwealth of Independent countries, including Russia and Turkey, and 22 Middle Eastern & North African countries.  Since 2011, XIAPEX has been approved for the treatment of Dupuytren's contracture in 28 EU member countries, Switzerland, and Norway.  Sobi, via its Partner Products business unit, will be primarily responsible for the applicable regulatory, clinical and commercialization activities for XIAPEX in Dupuytren's contracture and Peyronie's disease in these countries.

In April 2013, we completed enrollment in our placebo-controlled, randomized Phase II trial, Chien-804, to evaluate the efficacy of XIAFLEX for the treatment of subcutaneous benign lipomas in 32 canines randomized 1:1 XIAFLEX to placebo. The lipoma volume will be measured at baseline, 1 month and 3 months with the primary efficacy endpoint being the relative change in lipoma volume from baseline to 3 months, as determined by CT scan.
XML 28 R11.xml IDEA: COMPREHENSIVE INCOME (LOSS) 2.4.0.8060400 - Disclosure - COMPREHENSIVE INCOME (LOSS)truefalsefalse1false falsefalsec20130101to20130630http://www.sec.gov/CIK0000875622duration2013-01-01T00:00:002013-06-30T00:00:001true 1us-gaap_ComprehensiveIncomeNetOfTaxAbstractus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalse1falsefalsefalse00falsefalsefalsexbrli:stringItemTypestringfalse02false 2us-gaap_ComprehensiveIncomeNoteTextBlockus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00<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;">4. COMPREHENSIVE INCOME (LOSS)</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">For the three and six months ended <font style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">June 30, 2013 </font>and 2012, we had no components of other comprehensive income or loss other than net income itself.</div></div>falsefalsefalsenonnum:textBlockItemTypenaThe entire disclosure for comprehensive income, which includes, but is not limited to, 1) the amount of income tax expense or benefit allocated to each component of other comprehensive income, including reclassification adjustments, 2) the reclassification adjustments for each classification of other comprehensive income and 3) the ending accumulated balances for each component of comprehensive income.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 130 -Paragraph 14-26 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 220 -SubTopic 10 -Section 45 -Paragraph 14 -URI http://asc.fasb.org/extlink&oid=20435746&loc=d3e681-108580 Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 220 -SubTopic 10 -Section 45 -Paragraph 11 -URI http://asc.fasb.org/extlink&oid=20435746&loc=d3e637-108580 Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 505 -SubTopic 10 -Section S99 -Paragraph 1 -Subparagraph (SX 210.3-04) -URI http://asc.fasb.org/extlink&oid=6959260&loc=d3e187085-122770 Reference 5: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 220 -SubTopic 10 -Section 45 -Paragraph 15 -URI http://asc.fasb.org/extlink&oid=20435746&loc=d3e689-108580 Reference 6: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 220 -SubTopic 10 -Section 45 -Paragraph 1A -URI http://asc.fasb.org/extlink&oid=20435746&loc=SL7669619-108580 Reference 7: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 220 -SubTopic 10 -Section 45 -Paragraph 17 -URI http://asc.fasb.org/extlink&oid=20435746&loc=d3e716-108580 Reference 8: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 220 -SubTopic 10 -Section 45 -Paragraph 12 -URI http://asc.fasb.org/extlink&oid=20435746&loc=d3e640-108580 Reference 9: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 220 -SubTopic 10 -Section 45 -Paragraph 16 -URI http://asc.fasb.org/extlink&oid=20435746&loc=d3e709-108580 Reference 10: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Glossary Reclassification Adjustments -URI http://asc.fasb.org/extlink&oid=6522872 false0falseCOMPREHENSIVE INCOME (LOSS)UnKnownUnKnownUnKnownUnKnowntruefalsefalseSheethttp://biospecifics.com/role/ComprehensiveIncomeLoss12 XML 29 R11.htm IDEA: XBRL DOCUMENT v2.4.0.8
COMPREHENSIVE INCOME (LOSS)
6 Months Ended
Jun. 30, 2013
COMPREHENSIVE INCOME (LOSS) [Abstract]  
COMPREHENSIVE INCOME (LOSS)
4. COMPREHENSIVE INCOME (LOSS)

For the three and six months ended June 30, 2013 and 2012, we had no components of other comprehensive income or loss other than net income itself.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
6 Months Ended
Jun. 30, 2013
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
Basis of Presentation

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

The information included in this Report should be read in conjunction with our Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 and our Annual Report on Form 10-K for the year ended December 31, 2012 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, U.S. government securities, or short-term commercial paper.

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 June 30, 2013, the accounts receivable balance of $3.9 million was primarily from two customers, comprised of $2.5 million (64% of total) from DFB and $1.4 million (36% of total) from Auxilium.

The Company has been dependent in each year on two customers who generate almost all its revenues. In the quarter ended June 30, 2013, the licensing and royalty revenues from Auxilium were $4.7 million (65% of total) and royalty revenues from DFB were $2.5 million (35% of total).

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 of the cost of goods sold revenues. The royalty and mark-up on cost of goods sold revenues will generally be recognized in the quarter that Auxilium provides the written reports and related information to us, that is, royalty and mark-up on cost of goods sold revenues are generally recognized one quarter following the quarter in which the underlying sales by Auxilium occurred. The royalties payable by Auxilium to us are subject to set-off for certain patent costs.

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

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 U.S. Food and Drug Administration or other regulatory agencies require additional data or information, we would adjust our development period estimates accordingly. The impact on revenue of changes in our estimates and the timing thereof is recognized prospectively over the remaining estimated product development period.
 
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 two large pharmaceutical customers.  These companies have historically paid timely and have been financially stable organizations.  Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.  If the financial condition of our customers were to deteriorate, adversely affecting their ability to make payments, additional allowances would be required.  We provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. Balances that remain outstanding after we have used reasonable collection efforts are written off through a charge to the valuation allowance and a credit to accounts receivable.
 
At June 30, 2013, the accounts receivable balance of $3.9 million was primarily from two customers, comprised of $2.5 million from DFB and $1.4 million from Auxilium.
 
Deferred revenue of $0.5 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 in each of the last three years.  The allowance for doubtful accounts balance was approximately $30,000 at June 30, 2013 and 2012.
 
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 June 30, 2013 our net reimbursable third party patent costs accrual was approximately $30,000.

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 payable upon the occurrence of a milestone event.

As of June 30, 2013, we have capitalized $2.75 million related to this agreement which will be amortized over approximately five years beginning on the date of the first commercial sale of XIAFLEX for the treatment of Peyronie’s disease, which represents the period estimated to be benefited using the straight-line method. In accordance with Accounting Standards Codification 350, Intangibles, Goodwill and Other, the Company amortizes intangible assets with finite lives in a manner that reflects the pattern in which the economic benefits of the assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the assets are amortized using the straight-line method.
 
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. We granted to one of our consultants 15,000 stock options, valued at approximately $79,000, during the three month period ended June 30, 2013. We used the Black-Scholes valuation model to estimate the value of options using 37% volatility, a risk free rate of 0.68% and average exercise period of five years.

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
June 30,
  
Six Months Ended
June 30,
 
 
 
2013
  
2012
  
2013
  
2012
 
Research and development
 
$
79,049
  
$
122,679
  
$
92,249
  
$
144,817
 
General and administrative
  
-
   
13,200
   
13,200
   
30,868
 
Total stock-based compensation expense
 
$
79,049
  
$
135,879
  
$
105,449
  
$
175,685
 

Stock Option Activity

A summary of our stock option activity during the six months ended June 30, 2013 is presented below:

 
 
Total Number
  
Weighted-Average
 
Options
 
of Shares
  
Exercise Price
 
Outstanding as of December 31, 2012
  
1,182,000
  
$
8.90
 
Granted
  
15,000
   
15.85
 
Forfeited
  
-
   
-
 
Exercised
  
-
   
-
 
Expired
  
-
   
-
 
Outstanding as of June 30, 2013
  
1,197,000
  
$
8.99
 
 
Exercisable as of June 30, 2013
1,177,000
$
8.64
 
During the six months ended June 30, 2013 and 2012, zero and $78,000, respectively, were received from stock options exercised by option holders.

The aggregate intrinsic value of options outstanding and exercisable as of June 30, 2013 was approximately $8.2 million. Aggregate intrinsic value represents the total pre-tax intrinsic value based on the closing price of our common stock of $15.60 on June 28, 2013, which would have been received by the option holders had all option holders exercised their options as of that date. We have no unrecognized compensation cost related to stock options outstanding as of June 30, 2013.

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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RELATED PARTY TRANSACTIONS (Details) (ABC-NY [Member], USD $)
6 Months Ended
Jun. 30, 2013
ABC-NY [Member]
 
Related Party Transaction [Line Items]  
Monthly rental price $ 11,250
Termination of Lease Agreement Mar. 31, 2011
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Dec. 31, 2012
Stockholders' equity:    
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Series A Preferred stock, authorized (in shares) 700,000 700,000
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PROVISION FOR INCOME TAXES
6 Months Ended
Jun. 30, 2013
PROVISION FOR INCOME TAXES [Abstract]  
PROVISION FOR INCOME TAXES
7. PROVISION FOR INCOME TAXES

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3 Months Ended 6 Months Ended
Jun. 30, 2013
Jun. 30, 2012
Jun. 30, 2013
Jun. 30, 2012
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Other comprehensive income (loss) 0 0 0 0
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Consolidated Balance Sheets (unaudited) (USD $)
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Dec. 31, 2012
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Short-term investments 7,966,964 5,120,000
Accounts receivable, net 3,903,942 5,082,360
Income tax receivable 51,070 51,070
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Total current assets 16,430,099 13,875,801
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Deferred tax assets - long term 1,492,509 1,484,141
Patent costs, net 248,160 280,322
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Deferred tax liability 382,704 0
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Accrued liabilities of discontinued operations 78,138 78,138
Total current liabilities 1,199,730 724,528
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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 ; 6,625,168 shares issued at June 30, 2013 and December 31, 2012, respectively 6,625 6,625
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Retained earnings (deficit) 2,070,441 (310,829)
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Total stockholders' equity 19,548,213 17,458,346
Total liabilities and stockholders' equity $ 20,920,768 $ 18,390,264
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This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Regulation S-X (SX) -Number 210 -Section 02 -Paragraph k -Article 1 Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher AICPA -Name Accounting Principles Board Opinion (APB) -Number 18 -Paragraph 5, 6, 16-19 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 5: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 140 -Paragraph 46 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 6: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name FASB Interpretation (FIN) -Number 46R -Paragraph 4 -Subparagraph d -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 7: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Regulation S-X (SX) -Number 210 -Section 02, 03 -Article 3A Reference 8: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Emerging Issues Task Force (EITF) -Number 96-16 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 9: http://www.xbrl.org/2003/role/presentationRef -Publisher AICPA -Name Accounting Principles Board Opinion (APB) -Number 18 -Paragraph 20 -Subparagraph a(2) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 10: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name FASB Interpretation (FIN) -Number 46R -Paragraph 14, 15 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 11: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 235 -SubTopic 10 -Section 50 -Paragraph 3 -URI http://asc.fasb.org/extlink&oid=6367646&loc=d3e18780-107790 Reference 12: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 810 -SubTopic 10 -URI http://asc.fasb.org/subtopic&trid=2197480 Reference 13: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 810 -SubTopic 10 -Section 50 -Paragraph 1 -URI http://asc.fasb.org/extlink&oid=18733093&loc=d3e5614-111684 Reference 14: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 810 -SubTopic 10 -Section S99 -Paragraph 2 -Subparagraph (SX 210.3A-02) -URI http://asc.fasb.org/extlink&oid=6959686&loc=d3e355033-122828 Reference 15: http://www.xbrl.org/2003/role/presentationRef -Publisher AICPA -Name Accounting Research Bulletin (ARB) -Number 51 -Paragraph 2-6 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 16: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 860 -SubTopic 40 -Section 45 -URI http://asc.fasb.org/section&trid=2197723 Reference 17: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 323 -SubTopic 10 -URI http://asc.fasb.org/subtopic&trid=2196966 Reference 18: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 325 -SubTopic 20 -URI http://asc.fasb.org/subtopic&trid=2197087 Reference 19: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 323 -SubTopic 10 -Section 45 -Paragraph 4 -URI http://asc.fasb.org/extlink&oid=16385135&loc=d3e33801-111570 false04false 2us-gaap_UseOfEstimatesus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalseterseLabel1falsefalsefalse00<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;">Critical Accounting Policies, Estimates and Assumptions</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The preparation of consolidated financial statements in conformity with U.S. GAAP requires the use of management&#8217;s estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates.</div></div>falsefalsefalsenonnum:textBlockItemTypenaDisclosure of accounting policy for the use of estimates in the preparation of financial statements in conformity with generally accepted accounting principles.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 275 -SubTopic 10 -Section 50 -Paragraph 9 -URI http://asc.fasb.org/extlink&oid=6927468&loc=d3e6143-108592 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 275 -SubTopic 10 -Section 50 -Paragraph 8 -URI http://asc.fasb.org/extlink&oid=6927468&loc=d3e6132-108592 Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 275 -SubTopic 10 -Section 50 -Paragraph 4 -URI http://asc.fasb.org/extlink&oid=6927468&loc=d3e6061-108592 Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher AICPA -Name Statement of Position (SOP) -Number 94-6 -Paragraph 11, 14 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false05false 2us-gaap_CashAndCashEquivalentsPolicyTextBlockus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00<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;">Cash, Cash Equivalents and Short-term Investments</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Cash, cash equivalents and short-term investments are stated at market value. Cash equivalents include only securities having a maturity of three months or less at the time of purchase. The Company limits its credit risk associated with cash, cash equivalents and short-term investments by placing its investments with banks it believes are highly creditworthy and with highly rated money market funds, U.S. government securities, or short-term commercial paper.</div></div>falsefalsefalsenonnum:textBlockItemTypenaDisclosure of accounting policy for cash and cash equivalents, including the policy for determining which items are treated as cash equivalents. Other information that may be disclosed includes (1) the nature of any restrictions on the entity's use of its cash and cash equivalents, (2) whether the entity's cash and cash equivalents are insured or expose the entity to credit risk, (3) the classification of any negative balance accounts (overdrafts), and (4) the carrying basis of cash equivalents (for example, at cost) and whether the carrying amount of cash equivalents approximates fair value.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 235 -SubTopic 10 -Section 50 -Paragraph 3 -URI http://asc.fasb.org/extlink&oid=6367646&loc=d3e18780-107790 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Glossary Cash -URI http://asc.fasb.org/extlink&oid=6506951 Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Glossary Cash Equivalents -URI http://asc.fasb.org/extlink&oid=6507016 Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 230 -SubTopic 10 -Section 50 -Paragraph 1 -URI http://asc.fasb.org/extlink&oid=6367179&loc=d3e4273-108586 Reference 5: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Regulation S-X (SX) -Number 210 -Section 02 -Paragraph 1 -Article 5 Reference 6: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 305 -SubTopic 10 -URI http://asc.fasb.org/subtopic&trid=2122427 Reference 7: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Financial Reporting Release (FRR) -Number 203 -Paragraph 02-03 Reference 8: http://www.xbrl.org/2003/role/presentationRef -Publisher AICPA -Name Technical Practice Aid (TPA) -Number 2110 -Paragraph 6 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 9: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 95 -Paragraph 7, 8, 9, 10 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false06false 2us-gaap_FairValueMeasurementPolicyPolicyTextBlockus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00<div style="font-family: 'Times New Roman', Times, serif; font-size: 10pt;"><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>falsefalsefalsenonnum:textBlockItemTypenaDisclosure of accounting policy for fair value measurements, which may include, but is not limited to, how an entity that manages a group of financial assets and liabilities on the basis of its net exposure measures the fair value of those assets and liabilities.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 235 -SubTopic 10 -Section 50 -Paragraph 3 -URI http://asc.fasb.org/extlink&oid=6367646&loc=d3e18780-107790 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 820 -SubTopic 10 -Section 35 -Paragraph 18G -URI http://asc.fasb.org/extlink&oid=15229074&loc=SL7494712-110257 false07false 2us-gaap_ConcentrationRiskCreditRiskus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00<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;">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 June 30, 2013, the accounts receivable balance of $3.9 million was primarily from two customers, comprised of $2.5 million (64% of total) from DFB and $1.4 million (36% of total) from Auxilium.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The Company has been dependent in each year on two customers who generate almost all its revenues. In the quarter ended June 30, 2013, the licensing and royalty revenues from Auxilium were $4.7 million (65% of total) and royalty revenues from DFB were $2.5 million (35% of total).</div></div>falsefalsefalsenonnum:textBlockItemTypenaDisclosure of accounting policy for credit risk.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 825 -SubTopic 10 -Section 55 -Paragraph 2 -URI http://asc.fasb.org/extlink&oid=6875567&loc=d3e14537-108613 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name FASB Staff Position (FSP) -Number SOP94-6-1 -Paragraph 7, 11 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 107 -Paragraph 15A -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 113 -Paragraph 28 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 5: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 944 -SubTopic 825 -Section 55 -Paragraph 1 -URI http://asc.fasb.org/extlink&oid=6487554&loc=d3e32600-158583 Reference 6: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 825 -SubTopic 10 -Section 50 -Paragraph 20 -URI http://asc.fasb.org/extlink&oid=7491637&loc=d3e13531-108611 Reference 7: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 825 -SubTopic 10 -Section 50 -Paragraph 21 -URI http://asc.fasb.org/extlink&oid=7491637&loc=d3e13537-108611 Reference 8: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 942 -SubTopic 825 -Section 50 -Paragraph 2 -URI http://asc.fasb.org/extlink&oid=6480020&loc=d3e61082-112788 Reference 9: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 942 -SubTopic 825 -Section 50 -Paragraph 1 -URI http://asc.fasb.org/extlink&oid=6480020&loc=d3e61044-112788 Reference 10: http://www.xbrl.org/2003/role/presentationRef -Publisher AICPA -Name Statement of Position (SOP) -Number 01-6 -Paragraph 14 -Subparagraph m -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 11: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 825 -SubTopic 10 -Section 55 -Paragraph 1 -URI http://asc.fasb.org/extlink&oid=6875567&loc=d3e14489-108613 false08false 2us-gaap_RevenueRecognitionPolicyTextBlockus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00<div style="font-family: 'Times New Roman', Times, serif; font-size: 10pt;"><div style="text-align: left; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">Revenue Recognition</div><div style="text-align: left; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">&#160;</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">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, <font style="font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Revenue Recognition</font> (&#8220;ASC 605&#8221;).</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">&#160;</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">If we determine that separate elements exist in a revenue arrangement under ASC 605, we recognize revenue for delivered elements only when the fair values of undelivered elements are known, when the associated earnings process is complete, when payment is reasonably assured and, to the extent the milestone amount relates to our performance obligation, when our customer confirms that we have met the requirements under the terms of the agreement.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Revenues, and their respective treatment for financial reporting purposes, are as follows:</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">Product Sales</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">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.</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 of the cost of goods sold revenues. The royalty and mark-up on cost of goods sold revenues will generally be recognized in the quarter that Auxilium provides the written reports and related information to us, that is, royalty and mark-up on cost of goods sold revenues are generally recognized one quarter following the quarter in which the underlying sales by Auxilium occurred.<font style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">&#160;</font>The royalties payable by Auxilium to us are subject to set-off for certain patent costs.</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Under the DFB Agreement, pursuant to which we sold our topical collagenase business to DFB, we have the right to receive earn-out payments in the future based on sales of certain products. &#160;Generally, under the DFB Agreement we would receive payments and a report within ninety (90) days from the end of each calendar year after DFB has sold the royalty-bearing product.</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;">Licensing Revenue</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">We include revenue recognized from upfront licensing, sublicensing and milestone payments in &#8220;License Revenues&#8221; in our consolidated statements of operations in this Report.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Upfront License and Sublicensing Fees</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">We generally recognize revenue from upfront licensing and sublicensing fees when the agreement is signed, we have completed the earnings process and we have no ongoing performance obligation with respect to the arrangement. Nonrefundable upfront technology license for product candidates for which we are providing continuing services related to product development are deferred and recognized as revenue over the development period.</div><div><br /></div><div style="text-align: justify; font-style: italic; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Milestones</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Milestones, in the form of additional license fees, typically represent nonrefundable payments to be received in conjunction with the achievement of a specific event identified in the contract, such as completion of specified development activities and/or regulatory submissions and/or approvals. We believe that a milestone represents the culmination of a distinct earnings process when it is not associated with ongoing research, development or other performance on our part. We recognize such milestones as revenue when they become due and collection is reasonably assured. When a milestone does not represent the culmination of a distinct earnings process, we recognize revenue in a manner similar to that of an upfront license fee.</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">&#160;</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The timing and amount of revenue that we recognize from licenses of technology, either from upfront fees or milestones where we are providing continuing services related to product development, is primarily dependent upon our estimates of the development period. We define the development period as the point from which research activities commence up to regulatory approval of either our, or our partners&#8217; submission assuming no further research is necessary. As product candidates move through the development process, it is necessary to revise these estimates to consider changes to the product development cycle, such as changes in the clinical development plan, regulatory requirements, or various other factors, many of which may be outside of our control. Should the U.S. Food and Drug Administration or other regulatory agencies require additional data or information, we would adjust our development period estimates accordingly. The impact on revenue of changes in our estimates and the timing thereof is recognized prospectively over the remaining estimated product development period.</div></div>falsefalsefalsenonnum:textBlockItemTypenaDisclosure of accounting policy for revenue recognition. If the entity has different policies for different types of revenue transactions, the policy for each material type of transaction is generally disclosed. If a sales transaction has multiple element arrangements (for example, delivery of multiple products, services or the rights to use assets) the disclosure may indicate the accounting policy for each unit of accounting as well as how units of accounting are determined and valued. The disclosure may encompass important judgment as to appropriateness of principles related to recognition of revenue. The disclosure also may indicate the entity's treatment of any unearned or deferred revenue that arises from the transaction.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 235 -SubTopic 10 -Section 50 -Paragraph 3 -URI http://asc.fasb.org/extlink&oid=6367646&loc=d3e18780-107790 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 235 -SubTopic 10 -Section 50 -Paragraph 1 -URI http://asc.fasb.org/extlink&oid=6367646&loc=d3e18726-107790 Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Staff Accounting Bulletin (SAB) -Number Topic 13 -Section B -Paragraph Question 1 Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 605 -SubTopic 10 -Section S99 -Paragraph 1 -Subparagraph (SAB TOPIC 13.B.Q1) -URI http://asc.fasb.org/extlink&oid=6600647&loc=d3e214044-122780 Reference 5: http://www.xbrl.org/2003/role/presentationRef -Publisher AICPA -Name Accounting Principles Board Opinion (APB) -Number 22 -Paragraph 8, 12, 13 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. 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Reference 6: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 235 -SubTopic 10 -Section 50 -Paragraph 4 -URI http://asc.fasb.org/extlink&oid=6367646&loc=d3e18823-107790 false09false 2bstc_TreasuryStockPolicyTextBlockbstc_falsenadurationfalsefalsefalsefalsefalsefalsefalsefalseterseLabel1falsefalsefalse00<div style="font-family: 'Times New Roman', Times, serif; font-size: 10pt;"><div style="text-align: left; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">Treasury Stock</div><div style="text-align: left; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">&#160;</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders&#8217; equity.</div></div>falsefalsefalsenonnum:textBlockItemTypenaDisclosure of accounting policy for treasury stock.No definition available.false010false 2us-gaap_TradeAndOtherAccountsReceivablePolicyus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00<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;"><font style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Receivables, Deferred Revenue</font> and Allowance for Doubtful Accounts</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt; font-weight: bold;">&#160;</div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">Trade accounts receivable are stated at the amount the Company expects to collect. 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Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 310 -SubTopic 10 -Section 50 -Paragraph 6 -URI http://asc.fasb.org/extlink&oid=7512638&loc=d3e5093-111524 Reference 5: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 310 -SubTopic 20 -Section 50 -Paragraph 1 -URI http://asc.fasb.org/extlink&oid=6378556&loc=d3e10133-111534 Reference 6: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 310 -SubTopic 10 -Section 50 -Paragraph 15 -Subparagraph (d) -URI http://asc.fasb.org/extlink&oid=7512638&loc=d3e5212-111524 false011false 2bstc_ReimbursableThirdPartyDevelopmentCostsPolicyTextBlockbstc_falsenadurationfalsefalsefalsefalsefalsefalsefalsefalseterseLabel1falsefalsefalse00<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;">Reimbursable Third Party Development Costs</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">We accrue patent expenses for research and development that are reimbursable by us under the Auxilium Agreement. &#160;We capitalize certain patent costs related to estimated third party development costs that are reimbursable under the Auxilium Agreement. 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This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 5: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name FASB Interpretation (FIN) -Number 6 -Paragraph 5, 6, 8 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 6: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 141 -Paragraph 42 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. 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This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false017false 2us-gaap_IncomeTaxPolicyTextBlockus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00<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;">Provision for Income Taxes</div><div><br /></div><div style="text-align: justify; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">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. 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Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 235 -SubTopic 10 -Section 50 -Paragraph 3 -URI http://asc.fasb.org/extlink&oid=6367646&loc=d3e18780-107790 Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 740 -SubTopic 10 -Section 45 -Paragraph 25 -URI http://asc.fasb.org/extlink&oid=21917399&loc=d3e32247-109318 Reference 5: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 740 -SubTopic 10 -Section 50 -Paragraph 19 -URI http://asc.fasb.org/extlink&oid=6907707&loc=d3e32840-109319 Reference 6: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 740 -SubTopic 30 -URI http://asc.fasb.org/subtopic&trid=2144749 Reference 7: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 954 -SubTopic 740 -Section 50 -Paragraph 1 -URI http://asc.fasb.org/extlink&oid=6491622&loc=d3e9504-115650 Reference 8: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 740 -SubTopic 10 -URI http://asc.fasb.org/subtopic&trid=2144681 Reference 9: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 740 -SubTopic 10 -Section 50 -Paragraph 17 -Subparagraph (b) -URI http://asc.fasb.org/extlink&oid=6907707&loc=d3e32809-109319 Reference 10: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 740 -SubTopic 10 -Section 45 -Paragraph 28 -URI http://asc.fasb.org/extlink&oid=21917399&loc=d3e32280-109318 Reference 11: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 109 -Paragraph 6-34, 43, 47, 49 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. 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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) (USD $)
3 Months Ended 6 Months Ended
Jun. 30, 2013
Customer
Jun. 30, 2012
Mar. 31, 2012
Payment
Jun. 30, 2013
Quarter
Customer
Jun. 30, 2012
Jun. 28, 2013
Dec. 31, 2012
Concentration of Credit Risk and Major Customers [Abstract]              
Accounts receivable $ 3,903,942     $ 3,903,942     $ 5,082,360
Number of customers 2     2      
Royalty revenue 3,197,603 2,491,313   6,630,503 4,391,282    
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      
Number of years for which bad debt expense not recorded       3 years      
Allowance for doubtful accounts 30,000 30,000   30,000 30,000    
Reimbursable Third Party Development Costs [Abstract]              
Accrued patent costs 30,000     30,000      
Royalty Buy-Down [Abstract]              
Initial payment for royalty buy down     1,500,000 0 1,500,000    
Number of additional cash payments for royalty buy down     5        
Deferred royalty buy-down 2,750,000     2,750,000     2,750,000
Deferred costs, amortization period       5 years      
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]              
Stock granted during period, value of stock options 79,000            
Expected volatility rate       37.00%      
Risk free interest rate       0.68%      
Average exercise period       5 years      
Stock-based compensation expense 79,049 135,879   105,449 175,685    
Total number of shares              
Outstanding, beginning of period (in shares)       1,182,000      
Granted (in shares)       15,000      
Forfeited (in shares)       0      
Exercised (in shares)       0      
Expired (in shares)       0      
Outstanding, end of period (in shares) 1,197,000     1,197,000      
Exercisable, end of period (in shares) 1,177,000     1,177,000      
Weighted-Average Exercise Price              
Outstanding, beginning of period (in dollars per share)       $ 8.90      
Granted (in dollars per share)       $ 15.85      
Forfeited (in dollars per share)       $ 0      
Exercised (in dollars per share)       $ 0      
Expired (in dollars per share)       $ 0      
Outstanding, end of period (in dollars per share) $ 8.99     $ 8.99      
Exercisable, end of period (in dollars per share) $ 8.64     $ 8.64      
Proceeds from stock option exercises       0 78,000    
Aggregate intrinsic value of options outstanding and exercisable 8,200,000     8,200,000      
Closing price of Company stock (in dollars per share)           $ 15.60  
Unrecognized compensation cost related to non-vested stock options outstanding 0     0      
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 79,049 122,679   92,249 144,817    
General and Administrative [Member]
             
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]              
Stock-based compensation expense 0 13,200   13,200 30,868    
Auxilium [Member]
             
Concentration of Credit Risk and Major Customers [Abstract]              
Accounts receivable 1,400,000     1,400,000      
Royalty revenue 4,700,000            
Deferred revenue 500,000     500,000      
Auxilium [Member] | Accounts Receivable [Member]
             
Concentration of Credit Risk and Major Customers [Abstract]              
Concentration risk percentage (in hundredths)       36.00%      
Auxilium [Member] | Licensing, Consulting And Royalty Revenue [Member]
             
Concentration of Credit Risk and Major Customers [Abstract]              
Concentration risk percentage (in hundredths) 65.00%            
DFB Biotech Inc. [Member]
             
Concentration of Credit Risk and Major Customers [Abstract]              
Accounts receivable 2,500,000     2,500,000      
Royalty revenue $ 2,500,000            
DFB Biotech Inc. [Member] | Accounts Receivable [Member]
             
Concentration of Credit Risk and Major Customers [Abstract]              
Concentration risk percentage (in hundredths)       64.00%      
DFB Biotech Inc. [Member] | Licensing, Consulting And Royalty Revenue [Member]
             
Concentration of Credit Risk and Major Customers [Abstract]              
Concentration risk percentage (in hundredths) 35.00%            
XML 52 R13.htm IDEA: XBRL DOCUMENT v2.4.0.8
PATENT COSTS
6 Months Ended
Jun. 30, 2013
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 2 to 14 years, and review for impairment on a quarterly basis and when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable.

As of June 30, 2013, the Company’s capitalized costs related to certain patent costs paid by Auxilium on behalf of the Company, 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:

 
 
June 30,
  
December 31,
 
 
 
2013
  
2012
 
Patents
 
$
472,375
  
$
472,375
 
Accumulated Amortization
  
(224,215
)
  
(192,053
)
 
 
$
248,160
  
$
280,322
 

The amortization expense for patents for the six months ended June 30, 2013 was approximately $32,000. In the comparable period of 2012, the amortization expense for patents was approximately $29,000. The estimated aggregate amortization expense for each of the next five years is approximately as follows:

2014
 
$
53,000
 
2015
  
25,000
 
2016
  
20,000
 
2017
  
20,000
 
2018
  
20,000
 
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width: 1%; vertical-align: top;">&#160;</td><td valign="bottom" style="text-align: right; background-color: #ffffff; width: 9%; vertical-align: top;"><div style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">20,000</div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; background-color: #ffffff; width: 1%; vertical-align: top;">&#160;</td></tr><tr><td valign="bottom" style="background-color: #cceeff; width: 48%; vertical-align: top;"><div style="text-align: left; font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">2018</div></td><td valign="bottom" style="background-color: #cceeff; width: 1%; vertical-align: top;">&#160;</td><td valign="bottom" style="text-align: left; background-color: #cceeff; width: 1%; vertical-align: top;">&#160;</td><td valign="bottom" style="text-align: right; background-color: #cceeff; width: 9%; vertical-align: top;"><div style="font-family: ''Times New Roman'', Times, serif; font-size: 10pt;">20,000</div></td><td nowrap="nowrap" valign="bottom" style="text-align: left; 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SUBSEQUENT EVENTS
6 Months Ended
Jun. 30, 2013
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 August 9, 2013.
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ACCOUNTS PAYABLE AND ACCRUED EXPENSES
6 Months Ended
Jun. 30, 2013
ACCOUNTS PAYABLE AND ACCRUED EXPENSES [Abstract]  
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
5. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consisted of the following:

 
 
June 30,
  
December 31,
 
 
 
2013
  
2012
 
Trade accounts payable and accrued expenses
 
$
365,054
  
$
$ 304,635
 
Accrued legal and other professional fees
  
129,822
   
61,147
 
Accrued payroll and related costs
  
165,684
   
147,084
 
         
Total
 
$
660,560
  $512,866 
XML 57 R7.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statements of Cash Flows (unaudited) (Parenthetical) (USD $)
3 Months Ended
Jun. 30, 2013
Jun. 30, 2012
Supplemental disclosures of non-cash transactions:    
Patent costs accrued from Auxilium $ 30,000 $ 64,000
Patent amortization expenses $ 16,100 $ 29,000
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4bstc_ConcentrationOfCreditRiskAndMajorCustomersAbstractbstc_falsenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4falsefalsefalse00falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:stringItemTypestringfalse02false 5us-gaap_AccountsReceivableNetCurrentus-gaap_truedebitinstantfalsefalsefalsefalsefalsefalsefalsefalseverboseLabel1truefalsefalse39039423903942USD$falsetruefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse39039423903942USD$falsetruefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7truefalsefalse50823605082360USD$falsetruefalsexbrli:monetaryItemTypemonetaryAmount due from customers or clients, within one year of the balance sheet date (or the normal operating cycle, whichever is longer), for goods or services (including trade receivables) that 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5bstc_NumberOfCustomersbstc_falsenainstantfalsefalsefalsefalsefalsefalsefalsefalseterseLabel1truefalsefalse22falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse22falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:decimalItemTypedecimalNumber of Customers from which Company is getting revenue is being generated.No definition available.false2564false 5us-gaap_RoyaltyRevenueus-gaap_truecreditdurationfalsefalsefalsefalsefalsefalsefalsefalseterseLabel1truefalsefalse31976033197603USD$falsefalsefalse2truefalsefalse24913132491313USD$falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse66305036630503USD$falsefalsefalse5truefalsefalse43912824391282USD$falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:monetaryItemTypemonetaryRevenue earned during the period from the leasing or otherwise lending to a third party the entity's rights or 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Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer).No definition available.false212true 2bstc_RoyaltyBuyDownAbstractbstc_falsenadurationfalsefalsefalsefalsefalsefalsefalsefalseterseLabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4falsefalsefalse00falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:stringItemTypestringfalse013false 3bstc_PaymentForRoyaltyBuyDownbstc_falsecreditdurationfalsefalsefalsefalsefalsefalsefalsefalseverboseLabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3truefalsefalse15000001500000USD$falsefalsefalse4truefalsefalse00USD$falsefalsefalse5truefalsefalse15000001500000USD$falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:monetaryItemTypemonetaryThe cash outflow from initial payment related to the purchase of royalty interests.No definition available.false214false 3bstc_NumberOfAdditionalCashPaymentsForRoyaltyBuyDownbstc_falsenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3truefalsefalse55falsefalsefalse4falsefalsefalse00falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:integerItemTypeintegerThe number of additional cash payments for royalty buy-down.No definition available.false25615false 3us-gaap_DeferredCostsus-gaap_truedebitinstantfalsefalsefalsefalsefalsefalsefalsefalselabel1truefalsefalse27500002750000USD$falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse27500002750000USD$falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7truefalsefalse27500002750000USD$falsefalsefalsexbrli:monetaryItemTypemonetarySum of the carrying amounts of deferred costs that are expected to be recognized as a charge against earnings in periods after one year or beyond the normal operating cycle, if longer.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Regulation S-X (SX) -Number 210 -Section 02 -Paragraph 17 -Article 5 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 942 -SubTopic 210 -Section S99 -Paragraph 1 -Subparagraph (SX 210.9-03.10) -URI http://asc.fasb.org/extlink&oid=6876686&loc=d3e534808-122878 false216false 3bstc_DeferredCostsAmortizationPeriodbstc_falsenadurationfalsefalsefalsefalsefalsefalsefalsefalseterseLabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4falsefalsefalse005 yearsfalsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:durationItemTypenaThe duration period related to the amortization of deferred cost.No definition available.false017true 3us-gaap_EmployeeServiceShareBasedCompensationAllocationOfRecognizedPeriodCostsLineItemsus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4falsefalsefalse00falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:stringItemTypestringfalse018false 4us-gaap_StockGrantedDuringPeriodValueSharebasedCompensationus-gaap_truecreditdurationfalsefalsefalsefalsefalsefalsefalsefalseterseLabel1truefalsefalse7900079000USD$falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4falsefalsefalse00falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:monetaryItemTypemonetaryValue of stock (or other type of equity) granted during the period as a result of any equity-based compensation plan other than an employee stock ownership plan (ESOP), net of any shares forfeited. 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This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph 15 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false219false 4us-gaap_ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truetruefalse0.370.37falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsenum:percentItemTypepureThe estimated measure of the percentage by which a share price is expected to fluctuate during a period. Volatility also may be defined as a probability-weighted measure of the dispersion of returns about the mean. The volatility of a share price is the standard deviation of the continuously compounded rates of return on the share over a specified period. That is the same as the standard deviation of the differences in the natural logarithms of the stock prices plus dividends, if any, over the period.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -Subparagraph (f)(2)(ii) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph A240 -Subparagraph e(2)(b) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false020false 4us-gaap_ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truetruefalse0.00680.0068falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsenum:percentItemTypepureThe risk-free interest rate assumption that is used in valuing an option on its own shares.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -Subparagraph (f)(2)(iv) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph A240 -Subparagraph e(2)(d) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false021false 4us-gaap_SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1us-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4falsefalsefalse005 yearsfalsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:durationItemTypenaExpected term of share-based compensation awards, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section S99 -Paragraph 1 -Subparagraph (SAB TOPIC 14.D.2) -URI http://asc.fasb.org/extlink&oid=6793087&loc=d3e301413-122809 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -Subparagraph (f)(2)(i) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Staff Accounting Bulletin (SAB) -Number Topic 14 -Section D -Subsection 2 false022false 4us-gaap_AllocatedShareBasedCompensationExpenseus-gaap_truedebitdurationfalsefalsefalsefalsefalsefalsefalsefalseterseLabel1truefalsefalse7904979049USD$falsefalsefalse2truefalsefalse135879135879USD$falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse105449105449USD$falsefalsefalse5truefalsefalse175685175685USD$falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:monetaryItemTypemonetaryRepresents the expense recognized during the period arising from equity-based compensation arrangements (for example, shares of stock, unit, stock options or other equity instruments) with employees, directors and certain consultants qualifying for treatment as employees.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 1 -Subparagraph (b) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5047-113901 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph 64 -Subparagraph b -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section S99 -Paragraph 1 -Subparagraph (SAB TOPIC 14.F) -URI http://asc.fasb.org/extlink&oid=6793087&loc=d3e301413-122809 Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -Subparagraph (h)(1)(i) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 5: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph A240 -Subparagraph g(1) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 6: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Staff Accounting Bulletin (SAB) -Number Topic 14 -Section F false223true 3us-gaap_ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingRollForwardus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4falsefalsefalse00falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:stringItemTypestringfalse024false 4us-gaap_ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumberus-gaap_truenainstantfalsefalsefalsefalsefalsetruefalsefalseperiodStartLabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse11820001182000falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:sharesItemTypesharesThe number of shares reserved for issuance under stock option agreements awarded under the plan that validly exist and are outstanding as of the balance sheet date, including vested options.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -Subparagraph (c)(1)(i)-(ii) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph A240 -Subparagraph b(1)(a) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph A240 -Subparagraph b(1)(b) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false125false 4us-gaap_ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGrossus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse1500015000falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:sharesItemTypesharesGross number of share options (or share units) granted during the period.No definition available.false126false 4us-gaap_ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriodus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse00falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:sharesItemTypesharesThe number of shares under options that were cancelled during the reporting period as a result of occurrence of a terminating event specified in contractual agreements pertaining to the stock option plan.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -Subparagraph (c)(1)(iv)(3) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph A240 -Subparagraph b(1)(f) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false127false 4us-gaap_StockIssuedDuringPeriodSharesStockOptionsExercisedus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse00falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:sharesItemTypesharesNumber of share options (or share units) exercised during the current period.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Regulation S-X (SX) -Number 210 -Section 04 -Article 3 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 505 -SubTopic 10 -Section 50 -Paragraph 2 -URI http://asc.fasb.org/extlink&oid=6928386&loc=d3e21463-112644 Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 505 -SubTopic 10 -Section S99 -Paragraph 1 -Subparagraph (SX 210.3-04) -URI http://asc.fasb.org/extlink&oid=6959260&loc=d3e187085-122770 Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 210 -SubTopic 10 -Section S99 -Paragraph 1 -Subparagraph (SX 210.5-02.28,29) -URI http://asc.fasb.org/extlink&oid=6877327&loc=d3e13212-122682 Reference 5: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -Subparagraph (c)(1)(iv)(2) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 6: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Regulation S-X (SX) -Number 210 -Section 02 -Paragraph 29, 30 -Article 5 false128false 4us-gaap_ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExpirationsInPeriodus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalselabel1falsefalsefalse00falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse00falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:sharesItemTypesharesNumber of options or other stock instruments for which the right to exercise has lapsed under the terms of the plan agreements.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -Subparagraph (c)(1)(iv)(4) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph A240 -Subparagraph b(1)(g) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false129false 4us-gaap_ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumberus-gaap_truenainstantfalsefalsefalsefalsefalsefalsetruefalseperiodEndLabel1truefalsefalse11970001197000falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse11970001197000falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:sharesItemTypesharesThe number of shares reserved for issuance under stock option agreements awarded under the plan that validly exist and are outstanding as of the balance sheet date, including vested options.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -Subparagraph (c)(1)(i)-(ii) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph A240 -Subparagraph b(1)(a) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph A240 -Subparagraph b(1)(b) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false130false 4us-gaap_ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumberus-gaap_truenainstantfalsefalsefalsefalsefalsefalsetruefalseperiodEndLabel1truefalsefalse11770001177000falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse11770001177000falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsexbrli:sharesItemTypesharesThe number of shares into which fully or partially vested stock options outstanding as of the balance sheet date can be currently converted under the option plan.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -Subparagraph (c)(1)(iii) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph A240 -Subparagraph b(1)(c), d(2) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. 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This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false338false 4us-gaap_ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePriceus-gaap_truenainstantfalsefalsefalsefalsefalsefalsetruefalseperiodEndLabel1truefalsefalse8.648.64USD$falsetruefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4truefalsefalse8.648.64USD$falsetruefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalsenum:perShareItemTypedecimalThe weighted-average price as of the balance sheet date at which grantees can acquire the shares reserved for issuance on vested portions of options outstanding and currently exercisable under the stock option plan.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 718 -SubTopic 10 -Section 50 -Paragraph 2 -Subparagraph (c)(1)(iii) -URI http://asc.fasb.org/extlink&oid=6415400&loc=d3e5070-113901 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 123R -Paragraph A240 -Subparagraph b(1)(c) -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. 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5us-gaap_FiniteLivedIntangibleAssetsAmortizationExpenseYearFourus-gaap_truedebitinstantfalsefalsefalsefalsefalsefalsefalsefalselabel1truefalsefalse2000020000falsefalsefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4falsefalsefalse00falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalse8falsefalsefalse00falsefalsefalsexbrli:monetaryItemTypemonetaryAmount of amortization expense expected to be recognized during the fourth fiscal year following the latest fiscal year for assets, excluding financial assets and goodwill, lacking physical substance with a finite life.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 350 -SubTopic 30 -Section 50 -Paragraph 2 -Subparagraph (a)(3) -URI http://asc.fasb.org/extlink&oid=7658586&loc=d3e16323-109275 false213false 5us-gaap_FiniteLivedIntangibleAssetsAmortizationExpenseYearFiveus-gaap_truedebitinstantfalsefalsefalsefalsefalsefalsefalsefalseterseLabel1truefalsefalse2000020000USD$falsetruefalse2falsefalsefalse00falsefalsefalse3falsefalsefalse00falsefalsefalse4falsefalsefalse00falsefalsefalse5falsefalsefalse00falsefalsefalse6falsefalsefalse00falsefalsefalse7falsefalsefalse00falsefalsefalse8falsefalsefalse00falsefalsefalsexbrli:monetaryItemTypemonetaryAmount of amortization expense expected to be recognized during the fifth fiscal year following the latest fiscal year for assets, excluding financial assets and goodwill, lacking physical substance with a finite life.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 350 -SubTopic 30 -Section 50 -Paragraph 2 -Subparagraph (a)(3) -URI http://asc.fasb.org/extlink&oid=7658586&loc=d3e16323-109275 false2falsePATENT COSTS (Details) (USD $)NoRoundingUnKnownUnKnownUnKnowntruefalsefalseSheethttp://biospecifics.com/role/PatentCostsDetails813 XML 62 R28.xml IDEA: RELATED PARTY TRANSACTIONS (Details) 2.4.0.8090800 - Disclosure - RELATED PARTY TRANSACTIONS (Details)truefalsefalse1false USDfalsefalse$c20130101to20130630_RelatedPartyTransactionsByRelatedPartyAxis_AffiliatedEntityMemberhttp://www.sec.gov/CIK0000875622duration2013-01-01T00:00:002013-06-30T00:00:00U002Standardhttp://www.xbrl.org/2003/iso4217USDiso42170USDUSD$1false 0truefalsetruefalsefalsefalsefalsefalsefalse1falsefalsefalse00falsefalsefalse1false USDtruefalse$c20130101to20130630_RelatedPartyTransactionsByRelatedPartyAxis_AffiliatedEntityMemberhttp://www.sec.gov/CIK0000875622duration2013-01-01T00:00:002013-06-30T00:00:00falsefalseABC-NY 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NET INCOME (LOSS) PER SHARE (Tables)
6 Months Ended
Jun. 30, 2013
NET INCOME (LOSS) PER SHARE [Abstract]  
Number of Common Equivalent Shares Included for the Calculation of Diluted Net Income
The following table summarizes the number of common equivalent shares that were included for the calculation of diluted net income purposes from continuing operations reported in the consolidated statement of operations.

 
 
Three Months Ended
June 30,
  
Six Months Ended
June 30,
 
 
 
2013
  
2012
  
2013
  
2012
 
Stock options
  
622,780
   
628,331
   
614,962
   
644,328
 
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RELATED PARTY TRANSACTIONS
6 Months Ended
Jun. 30, 2013
RELATED PARTY TRANSACTIONS [Abstract]  
RELATED PARTY TRANSACTIONS
8. RELATED PARTY TRANSACTIONS

Our corporate headquarters are currently located at 35 Wilbur St., Lynbrook, NY 11563.  As previously reported, our previous lease for our headquarters terminated on June 30, 2010.  Our subsidiary, ABC-NY (together with the Company, the “Tenant”) and Wilbur St. Corp. (the “Landlord”) were parties to a lease agreement initially dated as of January 30, 1998 and modified as of June 24, 2009 (the “Lease Agreement”), pursuant to which the Landlord leased to the Tenant the premises located at 35 Wilbur Street, Lynbrook, NY 11563 (the “Premises”) until June 30, 2010 and for a monthly rental price of $11,250 plus utilities and real estate taxes.  Following the expiration of the Lease Agreement, the Tenant continued to lease the Premises from the Landlord on a month-to-month basis. We notified the Landlord of our termination of the Lease Agreement effective March 31, 2011, but continue to hold over in the Premises.
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ORGANIZATION AND DESCRIPTION OF BUSINESS (Details)
6 Months Ended
Jun. 30, 2013
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]  
Number of countries under the collaboration agreement 28
Minimum [Member]
 
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]  
Baseline measurement period for Lipoma volume 1 month
Maximum [Member]
 
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]  
Baseline measurement period for Lipoma volume 3 months
Central Eastern Europe Countries [Member]
 
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]  
Number of countries under the collaboration agreement 18
Middle Eastern & North African Countries [Member]
 
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]  
Number of countries under the collaboration agreement 22
XML 66 R15.xml IDEA: RELATED PARTY TRANSACTIONS 2.4.0.8060800 - Disclosure - RELATED PARTY TRANSACTIONStruefalsefalse1false falsefalsec20130101to20130630http://www.sec.gov/CIK0000875622duration2013-01-01T00:00:002013-06-30T00:00:001true 1us-gaap_RelatedPartyTransactionsAbstractus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalse1falsefalsefalse00falsefalsefalsexbrli:stringItemTypestringfalse02false 2us-gaap_RelatedPartyTransactionsDisclosureTextBlockus-gaap_truenadurationfalsefalsefalsefalsefalsefalsefalsefalseverboseLabel1falsefalsefalse00<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;As previously reported, our previous lease for our headquarters terminated on June 30, 2010. &#160;Our subsidiary, ABC-NY (together with the Company, the &#8220;Tenant&#8221;) and Wilbur St. Corp. (the &#8220;Landlord&#8221;) were parties to a lease agreement initially dated as of January 30, 1998 and modified as of June 24, 2009 (the &#8220;Lease Agreement&#8221;), pursuant to which the Landlord leased to the Tenant the premises located at 35 Wilbur Street, Lynbrook, NY 11563 (the &#8220;Premises&#8221;) until June 30, 2010 and for a monthly rental price of $11,250 plus utilities and real estate taxes. &#160;Following the expiration of the Lease Agreement, the Tenant continued to lease the Premises from the Landlord on a month-to-month basis. We notified the Landlord of our termination of the Lease Agreement effective March 31, 2011, but continue to hold over in the Premises.</div></div>falsefalsefalsenonnum:textBlockItemTypenaThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.Reference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 850 -SubTopic 10 -Section 50 -Paragraph 3 -URI http://asc.fasb.org/extlink&oid=6457730&loc=d3e39603-107864 Reference 2: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 850 -SubTopic 10 -Section 50 -Paragraph 4 -URI http://asc.fasb.org/extlink&oid=6457730&loc=d3e39622-107864 Reference 3: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 850 -SubTopic 10 -Section 50 -Paragraph 1 -URI http://asc.fasb.org/extlink&oid=6457730&loc=d3e39549-107864 Reference 4: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Regulation S-X (SX) -Number 210 -Section 04 -Paragraph b -Article 3A Reference 5: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 235 -SubTopic 10 -Section S99 -Paragraph 1 -Subparagraph (SX 210.4-08.(k)) -URI http://asc.fasb.org/extlink&oid=6881521&loc=d3e23780-122690 Reference 6: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Regulation S-X (SX) -Number 210 -Section 08 -Paragraph k -Article 4 Reference 7: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 850 -SubTopic 10 -Section 50 -Paragraph 6 -URI http://asc.fasb.org/extlink&oid=6457730&loc=d3e39691-107864 Reference 8: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Accounting Standards Codification -Topic 850 -SubTopic 10 -Section 50 -Paragraph 5 -URI http://asc.fasb.org/extlink&oid=6457730&loc=d3e39678-107864 Reference 9: http://www.xbrl.org/2003/role/presentationRef -Publisher FASB -Name Statement of Financial Accounting Standard (FAS) -Number 57 -Paragraph 1-4 -LegacyDoc This reference is SUPERSEDED by the Accounting Standards Codification effective for interim and annual periods ending after September 15, 2009. This reference is included to help users transition from the previous accounting hierarchy and will be removed from future versions of this taxonomy. false0falseRELATED PARTY TRANSACTIONSUnKnownUnKnownUnKnownUnKnowntruefalsefalseSheethttp://biospecifics.com/role/RelatedPartyTransactions12 XML 67 R20.htm IDEA: XBRL DOCUMENT v2.4.0.8
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables)
6 Months Ended
Jun. 30, 2013
ACCOUNTS PAYABLE AND ACCRUED EXPENSES [Abstract]  
Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following:

 
 
June 30,
  
December 31,
 
 
 
2013
  
2012
 
Trade accounts payable and accrued expenses
 
$
365,054
  
$
$ 304,635
 
Accrued legal and other professional fees
  
129,822
   
61,147
 
Accrued payroll and related costs
  
165,684
   
147,084
 
         
Total
 
$
660,560
  $512,866 
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Document and Entity Information
6 Months Ended
Jun. 30, 2013
Aug. 07, 2013
Document and Entity Information [Abstract]    
Entity Registrant Name BIOSPECIFICS TECHNOLOGIES CORP  
Entity Central Index Key 0000875622  
Current Fiscal Year End Date --12-31  
Entity Well-known Seasoned Issuer No  
Entity Voluntary Filers No  
Entity Current Reporting Status Yes  
Entity Filer Category Accelerated Filer  
Entity Common Stock, Shares Outstanding   6,339,815
Document Fiscal Year Focus 2013  
Document Fiscal Period Focus Q2  
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Jun. 30, 2013  
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PATENT COSTS (Tables)
6 Months Ended
Jun. 30, 2013
PATENT COSTS [Abstract]  
Net Patent Costs
For each period presented below net patent costs consisted of:

 
 
June 30,
  
December 31,
 
 
 
2013
  
2012
 
Patents
 
$
472,375
  
$
472,375
 
Accumulated Amortization
  
(224,215
)
  
(192,053
)
 
 
$
248,160
  
$
280,322
 
Estimated Aggregate Future Amortization Expense
The estimated aggregate amortization expense for each of the next five years is approximately as follows:

2014
 
$
53,000
 
2015
  
25,000
 
2016
  
20,000
 
2017
  
20,000
 
2018
  
20,000
 
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