0001140361-18-036043.txt : 20180809 0001140361-18-036043.hdr.sgml : 20180809 20180809134805 ACCESSION NUMBER: 0001140361-18-036043 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 45 CONFORMED PERIOD OF REPORT: 20180630 FILED AS OF DATE: 20180809 DATE AS OF CHANGE: 20180809 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: 181004385 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 10-Q

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

FORM 10-Q

(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
 EXCHANGE ACT OF 1934
 For the quarterly period ended June 30, 2018
OR

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 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 No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes No

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
Accelerated filer                  
Non-accelerated filer   (Do not check if a smaller reporting company)
Smaller reporting company
  Emerging growth company
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for comply with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

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

Yes No

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 8, 2018
Common Stock ($.001 par value)
7,294,888
 


BIOSPECIFICS TECHNOLOGIES CORP.

TABLE OF CONTENTS
 
Page
PART I – FINANCIAL INFORMATION
 
ITEM 1.
Financial Statements
4
5
6
7
ITEM 2.
19
ITEM 3.
26
ITEM 4.
27

PART II – OTHER INFORMATION
 
ITEM 1.
27
ITEM 1A.
27
ITEM 2.
27
ITEM 6.
28
29
 
Introductory Comments – Terminology

Throughout this Quarterly Report on Form 10-Q, the terms “BioSpecifics,” “Company,” “we,” “our,” and “us” refer to BioSpecifics Technologies Corp. and its subsidiary, Advance Biofactures Corp.

Throughout this Quarterly Report on Form 10-Q, Endo Global Ventures, a Bermuda unlimited liability company, an affiliate of Endo International plc, and Endo International plc are referred to collectively as “Endo”.
 
Introductory Comments – Forward-Looking Statements

This Report includes “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, expected revenue growth, and the assumptions underlying or relating to such statements, are “forward-looking statements.” The forward-looking statements in this Report include statements concerning, among other things, the continued commercialization of XIAFLEX to treat Dupuytren’s contracture and Peyronie’s disease; the continued marketing and commercialization of XIAFLEX to treat Dupuytren’s contracture and Peyronie’s disease in Europe, Eurasia, Japan, Canada, Australia and New Zealand; Endo’s ability to obtain required regulatory approvals; Endo’s ability to manufacture XIAFLEX at an acceptable cost, in a timely manner and with appropriate quality; successful development of XIAFLEX for additional indications; the ability to successfully develop, market and commercialize our drug candidates; the funding of research and development at medical institutions under agreements that are generally cancellable; the future receipt of payments from Endo, including milestone and royalty payments, in connection with the License Agreement; the plans for the repurchase of stock and reacquired stock; the suspension or discontinuation of the stock repurchase plan; the risk of doubtful accounts and how we provide for estimates of uncollectable accounts; the adoption of new accounting pronouncements and their impact; which accounting policies we consider to be critical to the estimates and judgments used to prepare the unaudited condensed consolidated financial statements; the effect of changes in interest rates on the Company’s results of operations, financial position and cash flow; changes in internal controls; the ability of internal controls and procedures to achieve desired control objectives; the existence of significant uncertain tax positions and provision for income taxes; the sufficiency of the Company’s available funds and cash flow from operations to meet our operational cash needs; whether the carrying amounts of the Company’s financial instruments approximate fair value due to the nature of the instruments; the changes in the Company’s exposure to market risk; the fair value of the Company’s stock option awards; whether the Company’s bank account balances will exceed insured limits; whether the Company is exposed to any significant credit risk on our cash; our milestone achievements and payments; whether we will continue to make payments to buy down our future royalty obligations; whether we will experience uneven payment flows due to the variance in financial terms in contracts with third parties to perform clinical trial activities and ongoing development of potential drugs; estimates concerning our development period; our interpretation of the definition of milestone; whether the Company will choose to cancel the lease prior to the expiration of the term; whether and when we will hear from Endo the results of their ongoing commercial review regarding the XIAFLEX pipeline; the timing of Endo’s determination of clinical trial timelines for additional indications; the nature of our accounts receivable balance and the timing of the Company’s release of top-line data in connection with its Phase 1 clinical trial of XIAFLEX for the treatment of uterine fibroids. In some cases, these statements can be identified by forward-looking words such as “believe,” “expect,” “anticipate,” “estimate,” “likely,” “may,” “will,” “can,” and “could,” the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on our current expectations and our projections about future events and various assumptions.  There can be no assurance that we will realize our expectations or that our beliefs will prove correct. 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 Endo and its partners, Asahi Kasei Pharma Corporation, Actelion Ltd. and Swedish Orphan Biovitrum AB, to achieve their objectives for XIAFLEX in their applicable territories; the market for XIAFLEX in, and timing, initiation and outcome of clinical trials for, additional indications that will determine the amount of milestone, royalty, mark-up on cost of goods sold, license and sublicense income BioSpecifics may receive; the potential of XIAFLEX to be used in additional indications; Endo modifying its objectives or allocating resources other than to XIAFLEX; and other risk factors identified in BioSpecifics’, Annual Report on Form 10-K for the year ended December 31, 2017, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 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, are expressly qualified in their entirety by the cautionary statements included in this Report and, except as may be required by law, we assume no obligation to update these forward-looking statements.
 
PART I – FINANCIAL INFORMATION

Item 1:
Condensed Consolidated Financial Statements

BioSpecifics Technologies Corp.
Condensed Consolidated Balance Sheets

  
June 30,
2018(1)
     
December 31,
2017
  
   
(unaudited)
   
(audited)
 
Assets
           
Current assets:
           
Cash and cash equivalents
 
$
12,960,475
   
$
7,333,810
 
Short term investments
   
53,585,924
     
51,973,971
 
Accounts receivable
   
12,893,893
     
4,655,105
 
Deferred royalty buy-down
   
1,124,990
     
1,794,126
 
Prepaid expenses and other current assets
   
836,979
     
623,503
 
Total current assets
   
81,402,261
     
66,380,515
 
                 
Long-term investments
   
7,163,483
     
5,745,974
 
Deferred royalty buy-down – long term, net
   
-
     
732,206
 
Deferred tax assets, net
   
321,603
     
1,739,706
 
Patent costs, net
   
442,968
     
397,993
 
                 
Total assets
 
$
89,330,315
   
$
74,996,394
 
                 
Liabilities and stockholders’ equity
               
Current liabilities:
               
Accounts payable and accrued expenses
 
$
1,591,707
   
$
933,998
 
Income tax payable
   
801,800
     
68,733
 
Deferred revenue
   
-
     
1,057,979
 
Accrued liabilities of discontinued operations
   
-
     
78,138
 
Total current liabilities
   
2,393,507
     
2,138,848
 
                 
Long-term deferred revenue
   
-
     
5,340,708
 
                 
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; 7,655,167 and 7,600,167 shares issued, 7,244,233 and 7,189,233 shares outstanding as of June 30, 2018 and December 31, 2017, respectively
   
7,655
     
7,600
 
Additional paid-in capital
   
34,424,632
     
33,468,323
 
Retained earnings
   
60,402,721
     
41,939,115
 
Treasury stock, 410,934 shares at cost as of June 30, 2018 and December 31, 2017
   
(7,898,200
)
   
(7,898,200
)
Total stockholders’ equity
   
86,936,808
     
67,516,838
 
                 
Total liabilities and stockholders’ equity
 
$
89,330,315
   
$
74,996,394
 

See accompanying notes to condensed consolidated financial statements.

(1)As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
 
BioSpecifics Technologies Corp.
Condensed Consolidated Income Statements
(unaudited)

   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2018(1)
   
2017
   
2018(1)
   
2017
 
Revenues:
                       
Royalties
 
$
7,061,139
   
$
6,531,107
   
$
14,146,139
   
$
14,217,317
 
Licensing revenues
   
35,270
     
4,409
     
39,679
     
8,818
 
Total Revenues
   
7,096,409
     
6,535,516
     
14,185,818
     
14,226,135
 
                                 
Costs and expenses:
                               
Research and development
   
211,796
     
337,731
     
407,023
     
592,512
 
General and administrative
   
1,985,212
     
2,315,283
     
4,054,845
     
4,741,000
 
Total Cost and Expenses
   
2,197,008
     
2,653,014
     
4,461,868
     
5,333,512
 
                                 
Operating income
   
4,899,401
     
3,882,502
     
9,723,950
     
8,892,623
 
                                 
Other income:
                               
Interest income
   
273,746
     
140,995
     
491,697
     
242,748
 
Other income
   
81,985
     
23,423
     
96,663
     
25,985
 
     
355,731
     
164,418
     
588,360
     
268,733
 
                                 
Income before income tax expense
   
5,255,132
     
4,046,920
     
10,312,310
     
9,161,356
 
Provision for income tax expense
   
(954,465
)
   
(1,422,829
)
   
(2,033,039
)
   
(3,192,512
)
                                 
Net income
 
$
4,300,667
   
$
2,624,091
   
$
8,279,271
   
$
5,968,844
 
                                 
                                 
Basic net income per share
 
$
0.60
   
$
0.37
   
$
1.15
   
$
0.83
 
Diluted net income per share
 
$
0.59
   
$
0.36
   
$
1.13
   
$
0.81
 
                                 
Shares used in computation of basic net income per share
   
7,215,057
     
7,170,223
     
7,204,040
     
7,167,251
 
Shares used in computation of diluted net income per share
   
7,315,276
     
7,329,118
     
7,309,325
     
7,330,875
 
 
See accompanying notes to condensed consolidated financial statements.
 
(1) As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
 
BioSpecifics Technologies Corp.
Condensed Consolidated Statements of Cash Flows
(unaudited)

   
Six Months Ended
June 30,
 
Cash flows from operating activities:
 
2018(1)
   
2017
 
Net income
 
$
8,279,271
   
$
5,968,844
 
Adjustments to reconcile net income to net cash provided by operating activities:
               
Amortization
   
1,369,227
     
1,084,614
 
Stock-based compensation expense
   
96,314
     
66,952
 
Deferred tax expense
   
82,341
     
218,006
 
Extinguishment of accrued liabilities
   
(78,138
)
   
-
 
Changes in operating assets and liabilities:
               
Accounts receivable
   
(684,061
)
   
(852,490
)
Income tax receivable
   
(666,874
)
   
204,506
 
Prepaid expenses and other current assets
   
(213,476
)
   
(176,202
)
Patent costs
   
(79,485
)
   
-
 
Accounts payable and accrued expenses
   
118,696
     
423,848
 
Deferred revenue
   
(139,680
)
   
(637,459
)
Net cash provided by operating activities
   
8,084,135
     
6,300,619
 
                 
Cash flows from investing activities:
               
Maturity of marketable investments
   
37,279,000
     
32,855,741
 
Purchases of marketable investments
   
(40,596,520
)
   
(37,669,248
)
Net cash used in investing activities
   
(3,317,520
)
   
(4,813,507
)
                 
Cash flows from financing activities:
               
Proceeds from stock option exercises
   
860,050
     
258,250
 
Payments for repurchase of common stock
   
-
     
(478,762
)
Net cash provided by (used in) financing activities
   
860,050
     
(220,512
)
                 
Increase in cash and cash equivalents
   
5,626,665
 
   
1,266,600
 
Cash and cash equivalents at beginning of year
   
7,333,810
     
4,763,364
 
Cash and cash equivalents at end of period
 
$
12,960,475
   
$
6,029,964
 
                 
Supplemental disclosures of cash flow information:
               
Cash paid during the period for:
               
Interest
   
-
     
-
 
Taxes
 
$
2,617,572
   
$
2,770,000
 
 
(1)As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.

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

June 30, 2018
(Unaudited)

1. ORGANIZATION AND DESCRIPTION OF BUSINESS

We are a biopharmaceutical company involved in the development of an injectable collagenase clostridium histolyticum for multiple indications. We currently have a development and license agreement with Endo Global Ventures, a Bermuda unlimited liability company (Endo Global Ventures), an affiliate of Endo International plc (Endo), for injectable collagenase for marketed indications and indications in development. Endo assumed this agreement when Endo acquired Auxilium Pharmaceuticals, Inc. (Auxilium) on January 29, 2015 (the Acquisition). Injectable collagenase clostridium histolyticum is marketed as XIAFLEX® (or Xiapex® in Europe).

On February 1, 2016, we entered into with Endo the First Amendment (the First Amendment) to the Second Amended and Restated Development and Licensing Agreement (the Auxilium Agreement), by and between us and Auxilium, now a wholly-owned subsidiary of Endo, to amend certain provisions of the Auxilium Agreement (as amended by the First Amendment, the License Agreement). The effective date of the First Amendment was January 1, 2016. Pursuant to the First Amendment, we and Endo mutually agreed that in exchange for a $8.25 million lump sum payment, we will not receive future additional mark-up on cost of goods sold for sales by non-affiliated sublicensees of Endo outside of the U.S.; provided, however, that Endo will still be required to pay a mark-up on cost of goods sold for sales made in the Endo Territory, which includes sales made in the U.S. and sales made in any other country where Endo sells the product directly or through affiliated sublicensees.

Additionally, we agreed that Endo may opt-in early to indications, prior to our submission of a clinical trial report, with our consent, such consent not to be unreasonably withheld. For early opt-ins, Endo will be required to make an opt-in payment of $0.5 million on a per indication basis. For regular opt-ins, following our submission of a clinical trial report, Endo will be required to make an opt-in payment of $0.75 million on a per indication basis.

The two marketed indications involving our injectable collagenase are Dupuytrens contracture and Peyronies disease. Prior to the Acquisition, Auxilium had, and after the Acquisition, Endo has, opted-in to the following indications: frozen shoulder, cellulite, canine lipoma, lateral hip fat, plantar fibromatosis and human lipoma. Endo exercised, with our consent, an early opt-in for lateral hip fat and plantar fibromatosis in November 2015. Endo opted-in for human lipoma in July 2016. We manage the development of XIAFLEX for uterine fibroids and initiate the development of XIAFLEX in new potential indications, not licensed by Endo.

On November 8, 2016, following a change in Endo management, Endo announced that a commercial review is ongoing of the XIAFLEX exercised but non-marketed indications, including frozen shoulder, cellulite, lateral hip fat, plantar fibromatosis and human lipoma, so that Endo can best prioritize its R&D efforts and determine clinical trial timelines moving forward. On February 6, 2018, Endo initiated two identical Phase 3 RELEASE clinical trials of XIAFLEX for the treatment of cellulite. The multicenter, randomized, double-blind, placebo-controlled RELEASE studies will evaluate the safety and efficacy of XIAFLEX in reducing the appearance of cellulite.

Endo is currently selling XIAFLEX in the U.S. for the treatment of Dupuytrens contracture and Peyronies disease and has an agreement with Swedish Orphan Biovitrum AB (Sobi), pursuant to which Sobi has marketing rights for Xiapex for Dupuytrens contracture and Peyronies disease in Europe and certain Eurasian countries. Sobi is currently selling Xiapex in Europe and certain Eurasian countries for the treatment of Dupuytrens contracture and Peyronies disease. In addition, Endo has an agreement with Asahi Kasei Pharma Corporation (Asahi) pursuant to which Asahi has the right to commercialize XIAFLEX for the treatment of Dupuytrens contracture and Peyronies disease in Japan. Asahi is selling XIAFLEX for the treatment of Dupuytrens contracture in Japan. Endo is currently distributing XIAFLEX in Canada through Paladin Labs Inc., an operating company of Endo. In December 2016, Endo entered into a new out-licensing agreement with Actelion Pharmaceuticals Ltd. (“Actelion”), pursuant to which Actelion obtained marketing and commercial rights for XIAFLEX in Australia and New Zealand.
 
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Except as detailed below, there have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2018, as compared to the significant accounting policies disclosed in Note 2 of the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.
 
Basis of Presentation

The accompanying condensed 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 the risk factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on March 14, 2018 and in Item 1A of Part 2 of our Quarterly Report on Form 10-Q for the quarter end March 31, 2018 filed with the SEC on May 10, 2018.
 
Principles of Consolidation

The condensed consolidated financial statements include the accounts of the Company and its subsidiary, Advance Biofactures Corp. All intercompany balances and transactions have been eliminated.

Critical Accounting Policies, Estimates and Assumptions

The preparation of condensed 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 condensed consolidated financial statements and accompanying notes. The Company makes certain assumptions and estimates for its revenues, deferred tax assets, third party royalties and deferred royalty buy-down. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and the amount of revenues and expenses. Actual results may differ from these estimates under different assumptions or conditions. For further details, see notes “Revenue Recognition”, “Provision for Income Taxes” and “Third-Party Royalties and Royalty Buy-Down.” Actual results may differ from those estimates.
 
Revenue Recognition

Beginning in 2014, Financial Accounting Standards Board (“FASB”) issued several Accounting Standards Updates establishing ASC Topic 606, “Revenue from Contracts with Customers” (“ASC 606”).  ASC 606 requires retrospective implementation, and replaces most industry-specific revenue recognition guidance in U.S. GAAP with a new principles-based, five-step revenue recognition model.  The Company adopted ASC 606 effective January 1, 2018. Under ASC 606, we recognize revenues when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. We recognize revenues following the five step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligation(s).

Revenues, and their respective treatment for financial reporting purposes under ASC 606 and our license agreement with Endo, are as follows:

Royalty / Mark-Up on Cost of Goods Sold
 
We receive royalty revenues on net sales and mark-up on cost of goods sold revenue in the U.S. under our License Agreement with Endo. These are presented in “Royalties” in our condensed consolidated statements of income.  We do not have future performance obligations under this revenue stream. In accordance with ASC 606, we record these revenues based on estimates of the net sales that occurred during the relevant period. The relevant period estimates of these royalties are based on interim data provided by Endo (when available) and analysis of historical royalties and mark-up on cost of goods sold revenue that have been paid to us, adjusted for any changes in facts and circumstances, as appropriate. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known, typically the following quarter. The royalties payable by Endo to us are subject to set-off for certain patent costs.
 
Licensing Revenue

We include revenue recognized from upfront licensing, sublicensing and milestone payments in “License Revenues” in our condensed consolidated statements of income.

The Company recognizes licensing revenues generated through development and/or commercialization agreements. The terms of these agreements typically include payment to the Company of one or more of the following: nonrefundable, upfront license fees; sublicensing; development and commercial milestone payments; development activities; and royalties on net sales of licensed products. Each of these types of payments results in licensing revenues except for revenues from royalties on net sales of licensed products and the mark-up of cost of goods sold revenues which are classified as royalty revenues. Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the customer.

For each development and/or commercialization agreement that result in revenues, the Company identifies all performance obligations, aside from those that are immaterial which may include a license to intellectual property and know-how, development activities and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.

If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, upfront license fees based on the relative standalone selling price prescribed to the license compared to the total value of the arrangement. The revenue is recognized when the license is transferred to the collaborator and the collaborator is able to use and benefit from the license.  For licenses that are not distinct from other obligations identified in the arrangement, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, the Company applies an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees.  The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

Development and Regulatory Milestone Payments

Depending on facts and circumstances, the Company may conclude that it is appropriate to include the milestone, representing variable consideration, in the estimated total transaction price, or that it is appropriate to fully constrain the milestone. The Company may include revenues from certain milestones in the total transaction price in a reporting period before the milestone is achieved if the Company concludes that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods. The Company records a corresponding contract asset when this conclusion is reached. Milestone payments that have not been included in the transaction price to date are fully constrained. The Company re-evaluates the probability of achievement of such development milestones and any related constraint each reporting period. The Company adjusts its estimate of the total transaction price, including the amount of revenue that it has recorded, if necessary.
 
RECENT ACCOUNTING PRONOUNCEMENTS

Accounting Pronouncements Adopted
 
Effective January 1, 2018, the Company adopted ASC 606, which provides principles for recognizing revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company adopted ASC 606 on a modified retrospective basis through a cumulative adjustment to equity. See Note 2 – Significant Accounting PoliciesRevenue Recognition.

The adoption of ASC 606 as of January 1, 2018, applying the modified-retrospective method, changed the timing of our recognition of royalty and mark-up cost of goods sold revenue. Beginning in 2018, we recorded these royalty revenues based on estimates of the net sales and mark-up cost of goods sold that occurred during the relevant period thereby eliminating the one quarter lag. Previously, these amounts were not recognized until they were fixed and determinable. In addition, deferred revenue associated with the prepayment of foreign mark-up on cost of goods sold revenue will no longer be recognized over time based on sales by non-affiliated sublicensees of Endo outside of the U.S. and, under ASC 606, would have been recognized when the transaction occurred in 2016.

The cumulative effect of applying the new guidance of ASC 606 to our License Agreement with Endo as of January 1, 2018 was recorded as an adjustment to retained earnings as of the adoption date. As a result of applying the modified retrospective method to adopt the new revenue guidance, the following adjustments were made to accounts on the Condensed Consolidated Balance Sheet as of January 1, 2018:

The Company recorded the following cumulative effect as of January 1, 2018, itemized here (in millions):
 
   
As reported
December 31, 2017
   
Adjustments
   
Adjusted
January 1, 2018
 
Accounts receivable
 
$
4.7
   
$
7.6
(1) 
 
$
12.3
 
Deferred revenue
   
(6.4
)
   
6.3
(2) 
   
(0.1
)
Deferred royalty buy-down
   
(2.5
)
   
(0.4
)(3)
   
(2.9
)
Accounts payable and accrued expenses -third party royalties
   
(0.4
)
   
(0.5
)(3)
   
(0.9
)
Deferred tax assets, net
   
1.7
     
(1.3
)(4)
   
0.4
 
Income tax payable
   
-
     
(1.4
)(5)
   
(1.4
)
                         
Retained earnings adjustment
 
$
(2.9
)
 
$
10.3
   
$
7.4
 
 
(1)
This adjustment represents the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017.
(2)
Represents the remaining deferred revenue balance of the prepaid mark-up on cost of goods sold based on sales by non-affiliated sublicensees of Endo outside of the U.S.
(3)
Represents the amortization of the royalty buy-down and third party royalties expense associated royalty revenues based on XIALFLEX net sales reported to us by Endo for the fourth quarter of 2017.
(4)
To reverse a deferred tax asset associated with the deferred revenue balance of the prepaid mark-up on cost of goods sold by non-affiliated sublicensees of Endo outside of the U.S.
(5)
To create a tax liability associated the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017.

At June 30, 2018, contract assets of $7.1 million for which there’s an unconditional right to receive payment was included in accounts receivable on the condensed consolidated balance sheet.
 
In accordance with the new revenue standard requirements, the impact of adoption on our condensed consolidated balance sheet was as follows (in millions):

   
June 30, 2018
 
   
As Reported
   
Balances Without
Adoption of New
Revenue Standard
   
Effect of Change
Higher / (Lower)
 
Assets
                 
Accounts receivable
 
$
12.9
   
$
5.8
   
$
7.1
 
Deferred royalty buy-down
   
1.1
     
1.3
     
(0.2
)
Deferred tax assets
   
0.3
     
1.5
     
(1.2
)
Liabilities
                       
Accounts payable and accrued expenses
   
1.6
     
1.1
     
0.5
 
Deferred revenue
   
-
     
0.9
     
(0.9
)
Income tax payable
   
0.8
     
0.5
     
(1.3
)
Deferred revenue, long term
   
-
     
4.9
     
(4.9
)
Equity
                       
Retained earnings
   
60.4
     
50.7
     
9.7
 
 
In accordance with the new revenue standard requirements, the impact of adoption on our condensed consolidated statement of operations for the three and six months ended June 30, 2018 was as follows (in millions):

   
Three Months Ended June 30, 2018
 
   
As Reported
   
Balances Without
Adoption of New
Revenue Standard
   
Effect of Change
Higher / (Lower)
 
Revenues
                 
Royalties
 
$
7.1
   
$
7.3
   
$
(0.2
)
Costs and expenses
                       
General and administrative
 
$
2.0
   
$
2.0
   
$
-
 
Provision for income taxes
   
1.0
     
1.0
     
-
 
Net income
   
4.3
     
4.5
     
(0.2
)

   
Six Months Ended June 30, 2018
 
   
As Reported
   
Balances Without
Adoption of New
Revenue Standard
   
Effect of Change
Higher / (Lower)
 
Revenues
                 
Royalties
 
$
14.2
   
$
15.0
   
$
(0.8
)
Costs and expenses
                       
General and administrative
 
$
4.1
   
$
4.1
   
$
-
 
Provision for income taxes
   
2.0
     
2.2
     
(0.2
)
Net income
   
8.3
     
8.9
     
(0.6
)

In January 2016, the FASB issued new guidance on recognition and measurement of financial assets and financial liabilities. The new guidance will impact the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. All equity investments in unconsolidated entities (other than those accounted for under the equity method of accounting) will generally be measured at fair value with changes in fair value recognized through earnings. There will no longer be an available-for-sale classification (changes in fair value reported in other comprehensive income (loss) for equity securities with readily determinable fair values). In addition, the FASB clarified the need for a valuation allowance on deferred tax assets resulting from unrealized losses on available-for-sale debt securities. In general, the new guidance will require modified retrospective application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings. The adoption of the new standard as of January 1, 2018 had no impact on our consolidated financial statements and related disclosure as we do not currently have any available-for-sale equity investments.
 
Accounting Pronouncements Not Yet Adopted

In February 2016, FASB issued Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842) (“ASU 2016-02”)Under the new guidance, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the lease commencement date: a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. Under the new guidance, lessor accounting is largely unchanged. Certain targeted improvements were made to align, where necessary, lessor accounting with the lessee accounting model and Topic 606, Revenue from Contracts with Customers. The new lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. Lessees will no longer be provided with a source of off-balance sheet financing. Public business entities should apply the amendments in ASU 2016-02 for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years (i.e., January 1, 2019, for a calendar year entity). Early application is permitted.  Lessees (for capital and operating leases) and lessors (for sales-type, direct financing, and operating leases) must apply a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. Lessees and lessors may not apply a full retrospective transition approach. We are currently evaluating the impact that the standard could have on our consolidated financial statements and related disclosures.
 
In June 2016, FASB issued ASU 2016-13, Financial Instruments - Credit Losses. The amendment revises the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in more timely recognition of losses on financial instruments, including, but not limited to, available for sale debt securities and accounts receivable. The Company is required to adopt this standard starting in the first quarter of fiscal year 2021. Early adoption is permitted. We are currently evaluating the impact of the adoption of this standard on our consolidated financial statements and related disclosures.

Cash, Cash Equivalents and Investments

Cash equivalents include only securities having a maturity of 90 days or less at the time of purchase.  Investments are stated on an amortized cost basis. The Company limits its credit risk associated with cash, cash equivalents and investments by placing its investments with banks it believes are highly creditworthy and with highly rated money market funds, certificates of deposit, municipal bonds and corporate bonds. All investments are classified as held to maturity. As of June 30, 2018 and December 31, 2017, the amortized cost of these investments was $60.7 million and $57.7 million, respectively. No unrealized gains or losses were recorded in either period.

Fair Value Measurements

Management believes that the carrying amounts of the Company’s financial instruments, including cash, cash equivalents, held to maturity investments, accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of those instruments. As of June 30, 2018 and December 31, 2017, there were no recorded unrealized gains or losses on our investments as they are classified as held to maturity. As of June 30, 2018 and December 31, 2017, amortized cost basis of the investments approximated their fair value. At June 30, 2018 and December 31, 2017, the amortized premium included in interest income was $288,000 and $673,000, respectively.

The following table presents the Company’s schedule of maturities at June 30, 2018 and December 31, 2017:
 
   
Maturities as of
June 30, 2018
   
Maturities as of
December 31, 2017
 
   
1 Year or
Less
   
Greater than 1
Year
   
1 Year or
Less
   
Greater than
1 Year
 
Municipal bonds
 
$
4,870,100
   
$
-
   
$
1,002,650
   
$
100,000
 
Corporate bonds
   
45,120,776
     
5,417,988
     
48,143,495
     
3,155,573
 
Certificates of deposit
   
3,595,048
     
1,745,495
     
2,827,826
     
2,490,401
 
Total
 
$
53,585,924
   
$
7,163,483
   
$
51,973,971
   
$
5,745,974
 
 
The authoritative literature for fair value measurements established a three-tier fair value hierarchy, which prioritizes the inputs in measuring fair value. These tiers are as follows: Level 1, defined as observable inputs such as quoted market prices in active markets; Level 2, defined as inputs other than the quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as significant unobservable inputs (entity developed assumptions) in which little or no market data exists.
 
As of June 30, 2018, the Company held certain investments that are required to be measured at fair value on a recurring basis. The following tables present the Company’s fair value hierarchy for these financial assets as of June 30, 2018 and December 31, 2017:
 
June 30, 2018
 
Type of Instrument
 
Fair Value
   
Level 1
   
Level 2
   
Level 3
 
                             
Cash equivalents
 
Institutional Money Market
 
$
4,928,319
   
$
4,928,319
   
$
-
   
$
-
 
                                     
Cash equivalents
 
Municipal Bonds
   
2,520,000
     
2,520,000
     
-
     
-
 
                                     
Cash equivalents
 
Corporate Bonds
   
1,862,000
     
1,862,000
     
-
     
-
 
                                     
Investments
 
Municipal Bonds
   
4,870,100
     
-
     
4,870,100
     
-
 
                                     
Investments
 
Corporate Bonds
   
50,538,764
     
-
     
50,538,764
     
-
 
                                     
Investments
 
Certificates of Deposit
   
5,340,543
     
5,340,543
     
-
     
-
 

December 31, 2017
 
Type of Instrument
 
Fair Value
   
Level 1
   
Level 2
   
Level 3
 
                             
Cash equivalents
 
Institutional Money Market
 
$
3,108,549
   
$
3,108,549
   
$
-
   
$
-
 
                                     
Cash equivalents
 
Municipal Bonds
   
800,000
     
-
     
800,000
     
-
 
                                     
Investments
 
Municipal Bonds
   
1,102,650
     
-
     
1,102,650
     
-
 
                                     
Investments
 
Corporate Bonds
   
51,299,068
     
-
     
51,299,068
     
-
 
                                     
Investments
 
Certificates of Deposit
   
5,318,227
     
5,318,227
     
-
     
-
 

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 investments in FDIC insured certificates of deposits, municipal bonds and corporate bonds.

The Company is currently dependent on one customer, Endo, who generates almost all its revenues. For the three and six months ended June 30, 2018, licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately $7.1 million and $14.2 million, respectively, and for the three and six months ended June 30, 2017, the licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately $6.5 million and $14.2 million, respectively.

At June 30, 2018 and December 31, 2017, our accounts receivable balances from Endo were $12.9 million and $4.7 million, respectively.

Treasury Stock
 
The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders’ equity. For the six months ended June 30, 2018, there were no shares repurchased as compared to the repurchase of 9,283 shares at an average price of $51.57 in the corresponding 2017 period.
 
Receivables and Doubtful Accounts
 
Trade accounts receivable are stated at the amount the Company expects to collect. We may maintain allowances for doubtful accounts for estimated losses resulting from the inability of our 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 Endo, our one large specialty pharmaceutical customer.  Endo has historically paid timely and has been a financially stable organization.  Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.  If the financial condition of our customer were to deteriorate, adversely affecting its ability to make payments, additional allowances would be required.  We may 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, 2018 and December 31, 2017 our accounts receivable balance was $12.9 million and $4.7 million, respectively, and was from one customer, Endo. With the adoption of ASC 606 as of January 1, 2018, using the modified-retrospective adoption method, we recorded an adjustment to our accounts receivable balance of $7.6 million related to royalties associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)

Deferred Revenue

With the adoption of ASC 606 using the modified retrospective adoption method as of January 1, 2018, the remaining deferred revenue balance associated with the mark-up on cost of goods sold for sales by non-affiliated sublicensees of Endo outside of the U.S. as of December 31, 2017 of $6.3 million was recorded as an adjustment to our retained earnings. Additionally, approximately $35,000 related to nonrefundable upfront product license fees for product candidates for which we have no remaining performance obligations was recognized during the second quarter of 2018. Finally, during the second quarter of 2018 we determined that the $100,000 related to a milestone payment withheld by Endo due to a foreign tax withholding was uncollectable and have reduced this amount to zero. As of June 30, 2018 and December 31, 2017, deferred revenue was zero and $6.4 million, respectively. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)

Reimbursable Third-Party Patent Costs

We accrue patent costs that are reimbursable to Endo by us under the License Agreement. We capitalize certain patent costs related to patent prosecution and maintenance and expense others. As of June 30, 2018 and December 31, 2017, our net reimbursable third party patent expense was $49,000 and zero, respectively.

Third-Party Royalties

We have entered into licensing and royalty agreements with third parties and agreed to pay certain royalties on net sales of products for specific indications. The royalty rates differ from agreement to agreement and, in certain cases, have been redacted with the permission of the SEC.  No assumptions should be made that any disclosed royalty rate payable to a particular third party is the same or similar with respect to any royalty rate payable to any other third parties. We accrue third-party royalty expenses on net sales reported to us by Endo. Third-party royalty costs are generally expensed under general and administrative in the quarter that the net sales have occurred. For the three and six month periods ended June 30, 2018, third-party royalty expenses were $0.5 million and $1.0 million, respectively. For the three and six month periods ended June 30, 2017, third-party royalty expenses were $0.4 million and $0.9 million, respectively. With the adoption of ASC 606 as of January 1, 2018 using the modified-retrospective adoption method, we recorded an adjustment to our retained earnings for third party royalties expense of $0.5 million associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag. Our third-party royalty expense under general and administrative expenses may increase if net sales by Endo and its partners for XIAFLEX and Xiapex increase and potential new indications for XIAFLEX and Xiapex are approved, marketed and sold. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)
 
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 in connection with 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 of $600,000, all of which have been paid as of June 30, 2018.  Royalty obligations terminate five years after first commercial sale which occurred in January 2014. The Company amortizes long-term contracts with finite lives in a manner that reflects the pattern in which the economic benefits of the assets are consumed or otherwise used up. Dr. Gelbard’s agreement is amortized based on an income forecast method by estimating sales of XIAFLEX and Xiapex for Peyronie’s disease on an annual basis as measured by the proportion of the total estimated sales over the five year period. For the three and six months ended June 30, 2018 and 2017, we amortized approximately $0.5 million and $1.0 million related to this agreement, respectively and $0.4 million and $0.7 million for the three and six months ended June 30, 2017. With the adoption of ASC 606 as of January 1, 2018 using the modified-retrospective adoption method, we recorded an adjustment to our capitalized balance of $0.4 million related to royalties associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag. As of June 30, 2018 and December 31, 2017, the remaining capitalized balances were approximately $1.1 million and $2.5 million, respectively. We perform an evaluation of the recoverability of the carrying value to determine if facts and circumstances indicate that the carrying value of the assets may be impaired and if any adjustment is warranted.  As of June 30, 2018, there was no indicator that an impairment existed. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)

Research and Development Expenses

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 consultants. 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 one stock-based compensation plan 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 stock options including stock options and common stock issued to our employees and directors under our stock plans. ASC 718 requires companies to estimate the fair value of stock option 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 condensed consolidated statements of operations.
 
Under ASC 718, we estimate the fair value of our employee stock option 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 option award, we consider the vesting period for the award, our recent historical experience of employee stock option exercises (including forfeitures) and the expected volatility of our common stock.  As required under the accounting rules, we review our estimates at each grant date and, as a result, the valuation assumptions that we use to value employee stock-based awards granted in future periods may change. For the six months ended June 30, 2018, we granted a total of 31,500 stock options with a weighted average grant date fair value of $18.00 per share.
 
The assumptions used in the valuation of stock options granted during the six months ended June 30, 2018 were as follows:

 
Six Months Ended
June 30, 2018
 
Risk-free interest rate
 
2.62% to 2.81
%
Expected term of option
 
6.25 years
 
Expected stock price volatility
 
39.6% to 39.7
%
Expected dividend yield
 
$
0.0
 
 
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 in general and administrative expenses was approximately $63,000 and $96,000 for the three and six month periods ended June 30, 2018 and approximately $33,000 and $67,000 for the three and six months ended June 30, 2017, respectively.

Stock Option Activity

A summary of our stock option activity during the six months ended June 30, 2018 is presented below:
 
   
Shares
   
Weighted
Average
Exercise
Price
   
Weighted
Average
Remaining
Contractual
Term
   
Aggregate
Intrinsic
Value
 
Outstanding at December 31, 2017
   
232,000
   
$
21.56
     
2.52
   
$
5,050,990
 
Grants
   
31,500
     
41.79
     
-
     
-
 
Exercised
   
(55,000
)
   
15.64
     
-
     
1,454,650
 
Forfeitures or expirations
   
-
     
-
     
-
     
-
 
Outstanding at June 30, 2018
   
208,500
   
$
26.18
     
3.37
   
$
3,895,465
 
Exercisable at June 30, 2018
   
169,500
   
$
22.77
     
2.04
   
$
3,744,550
 

During the six months ended June 30, 2018 and 2017, the Company received approximately $860,000 and $258,000, respectively, from stock options exercised by option holders.

Aggregate intrinsic value represents the total pre-tax intrinsic value based on the closing price of our common stock of $44.86 on June 29, 2018, which would have been received by the option holders had all option holders exercised their options as of that date. We have approximately $611,000 in unrecognized compensation cost related to stock options outstanding as of June 30, 2018, which we expect to recognize over the next 3.31 years.
 
Property and Equipment

Property and equipment are stated at cost, less accumulated depreciation. Machinery and equipment, furniture and fixtures, and autos are depreciated on a straight-line basis over their estimated useful lives of five to ten years. Leasehold improvements are amortized over the lesser of their estimated useful lives or the remaining life of the lease. At each of June 30, 2018 and December 31, 2017, property and equipment were fully depreciated.

Comprehensive Income

For each of the three and six month periods ended June 30, 2018 and 2017, we had no components of other comprehensive income other than net income itself.

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.

The Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon the ultimate settlement. As of June 30, 2018 and December 31, 2017, the Company has not recorded any unrecognized tax benefits.

Commitments and Contingencies

On November 6, 2017, the Company entered into an agreement with the Landlord to extend the term of the lease to the Headquarters for an additional one year period (the “Extended Lease Agreement”). The one year extension will end on November 30, 2018. Pursuant to the Extended Lease Agreement, the base rent is $11,165 per month and the Company may cancel the lease with three months’ prior written notice to the Landlord at any time during the term.

3. NET INCOME PER SHARE

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

The following table summarizes the number of common equivalent shares that were excluded for the calculation of diluted net income per share reported in the condensed consolidated statement of operations.

   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2018
   
2017
   
2018
   
2017
 
Stock options
   
-
     
20,000
     
-
     
20,000
 

For the three and six months ended June 30, 2017, the Company had 20,000 options, which have an exercise price of $29.21, and would have vested upon the achievement of certain performance criteria, which were not met.  These options would have expired on December 2, 2019.  On October 25, 2017, these 20,000 options were cancelled due to a change in status of a certain consultant.
 
4. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consisted of the following:

   
June 30,
2018
   
December 31,
2017
 
Trade accounts payable
 
$
34,553
   
$
152,542
 
Accrued legal and other professional fees
   
219,223
     
150,691
 
Accrued payroll and related costs
   
182,746
     
215,322
 
Third party royalties
   
1,018,308
     
329,211
 
Other accruals
   
136,877
     
86,232
 
Total
 
$
1,591,707
   
$
933,998
 

5. PATENT COSTS

We amortize intangible assets with definite lives on a straight-line basis over their remaining estimated useful lives, ranging from two to ten 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.  We analyze our intangible assets, specifically, capitalized patent costs, on an annual basis for any indicator that an impairment exists.

For the six months ended June 30, 2018, we increased our capitalized patent costs based on reports provided to us by Endo. Patent costs may be creditable against future royalty revenues. For each period presented below, net patent costs consisted of:

   
June 30,
2018
   
December 31,
2017
 
Patents
   
1,004,502
   
$
925,016
 
Accumulated amortization
   
(561,534
)
   
(527,023
)
   
$
442,968
   
$
397,993
 

The amortization expense for patents for the three and six months ended June 30, 2018 was approximately $18,000 and $35,000, respectively and for the three and six months ended June 30, 2017 was approximately $10,000 and $20,000, respectively. The estimated aggregate amortization expense for the remaining six months of 2018 and each of the years below is approximately as follows:
 
July 1, 2018 - December 31, 2018
 
$
36,000
 
2019
   
69,700
 
2020
   
53,700
 
2021
   
37,800
 
2022
   
37,800
 
Thereafter
   
208,000
 

6. PROVISION FOR INCOME TAXES

Our deferred tax liabilities and deferred tax assets are impacted by events and transactions arising in the ordinary course of business, R&D activities, vesting of nonqualified options and other items. The provision for income taxes is based on an estimated effective tax rate derived from our consolidated earnings before taxes, adjusted for nondeductible expenses and other permanent differences for the fiscal year. For the three and six months ended June 30, 2018, the provision for income taxes was $1.0 million and $2.0 million, respectively. As of June 30, 2018 and December 31, 2017, our remaining deferred tax assets were approximately $0.3 million and $1.7 million, respectively.

For the three and six months ended June 30, 2017, the provision for income taxes was $1.4 million and $3.2 million, respectively.
 
The estimated effective tax rate for the three and six months ended June 30, 2018 was 18.2% and 19.7%, respectively, of pre-tax income reported in the period, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2018 plus the effects of certain discrete items occurring in 2018. Our effective tax rate for the six months ended June 30, 2018 was impacted primarily by the Tax Cuts and Jobs Act of 2017, which was enacted on December 22, 2017 and lowered the U.S. corporate tax rate from 35% to 21%, beginning in 2018. Our effective tax rate was also impacted by the discrete impact of current period stock option exercises which impacts the effective rate in the period in which it occurs. The effective tax rate for the six months ended June 30, 2017 was 34.8% of pre-tax income reported in the period, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2017 plus the effects of certain material discrete items that occurred in 2017.
 
As of June 30, 2018, the Company has no unrecognized tax benefits or related interest and penalties. Management does not believe that there is any tax position which it is reasonably possible that will result in unrecognized tax benefit within the next 12 months.
 
Item 2:
Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion should be read in conjunction with the condensed 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 clostridium histolyticum for multiple indications. We currently have a development and license agreement with Endo Global Ventures, a Bermuda unlimited liability company (Endo Global Ventures), an affiliate of Endo International plc (Endo), for injectable collagenase for marketed indications and indications in development. Endo assumed this agreement when Endo acquired Auxilium Pharmaceuticals, Inc. (Auxilium) on January 29, 2015 (the Acquisition). Injectable collagenase clostridium histolyticum is marketed as XIAFLEX® (or Xiapex® in Europe).

On February 1, 2016, we entered into with Endo the First Amendment (the First Amendment) to the Second Amended and Restated Development and Licensing Agreement (the Auxilium Agreement), by and between us and Auxilium, now a wholly-owned subsidiary of Endo, to amend certain provisions of the Auxilium Agreement (as amended by the First Amendment, the License Agreement). The effective date of the First Amendment was January 1, 2016. Pursuant to the First Amendment, we and Endo mutually agreed that in exchange for a $8.25 million lump sum payment, we will not receive future additional mark-up on cost of goods sold for sales by non-affiliated sublicensees of Endo outside of the U.S.; provided, however, that Endo will still be required to pay a mark-up on cost of goods sold for sales made in the Endo Territory, which includes sales made in the U.S. and sales made in any other country where Endo sells the product directly or through affiliated sublicensees.

Additionally, we agreed that Endo may opt-in early to indications, prior to our submission of a clinical trial report, with our consent, such consent not to be unreasonably withheld. For early opt-ins, Endo will be required to make an opt-in payment of $0.5 million on a per indication basis. For regular opt-ins, following our submission of a clinical trial report, Endo will be required to make an opt-in payment of $0.75 million on a per indication basis.

The two marketed indications involving our injectable collagenase are Dupuytrens contracture and Peyronies disease. Prior to the Acquisition, Auxilium had, and after the Acquisition, Endo has, opted-in to the following indications: frozen shoulder, cellulite, canine lipoma, lateral hip fat, plantar fibromatosis and human lipoma. Endo exercised, with our consent, an early opt-in for lateral hip fat and plantar fibromatosis in November 2015. Endo opted-in for human lipoma in July 2016. We manage the development of XIAFLEX for uterine fibroids and initiate the development of XIAFLEX in new potential indications, not licensed by Endo.

On November 8, 2016, following a change in Endo management, Endo announced that a commercial review is ongoing of the XIAFLEX exercised but non-marketed indications, including frozen shoulder, cellulite, lateral hip fat, plantar fibromatosis and human lipoma, so that Endo can best prioritize its R&D efforts and determine clinical trial timelines moving forward. On February 6, 2018, Endo initiated two identical Phase 3 RELEASE clinical trials of XIAFLEX for the treatment of cellulite. The multicenter, randomized, double-blind, placebo-controlled RELEASE studies will evaluate the safety and efficacy of XIAFLEX in reducing the appearance of cellulite.

Endo is currently selling XIAFLEX in the U.S. for the treatment of Dupuytrens contracture and Peyronies disease and has an agreement with Swedish Orphan Biovitrum AB (Sobi), pursuant to which Sobi has marketing rights for Xiapex for Dupuytrens contracture and Peyronies disease in Europe and certain Eurasian countries. Sobi is currently selling Xiapex in Europe and certain Eurasian countries for the treatment of Dupuytrens contracture and Peyronies disease. In addition, Endo has an agreement with Asahi Kasei Pharma Corporation (Asahi) pursuant to which Asahi has the right to commercialize XIAFLEX for the treatment of Dupuytrens contracture and Peyronies disease in Japan. Asahi is selling XIAFLEX for the treatment of Dupuytrens contracture in Japan. Endo is currently distributing XIAFLEX in Canada through Paladin Labs Inc., an operating company of Endo. In December 2016, Endo entered into a new out-licensing agreement with Actelion Pharmaceuticals Ltd. (“Actelion”), pursuant to which Actelion obtained marketing and commercial rights for XIAFLEX in Australia and New Zealand.
 
Operational Highlights

Our Phase 1 clinical trial of Collagenase Clostridium Histolyticum (CCH) for the treatment of uterine fibroids is ongoing and we plan to announce the results in 2018. The study, being conducted at the Department of Gynecology & Obstetrics at Johns Hopkins University, is designed to enroll 15 female subjects treated prior to hysterectomy. The primary endpoint of the study will assess the safety and tolerability of a single injection of XIAFLEX directly into the uterine fibroids under transvaginal ultrasound guidance. The secondary endpoints will assess symptoms of pain and bleeding, quality of life throughout the study, shrinkage of XIAFLEX treated fibroids in size, increased rates of apoptosis in treated fibroids and a decrease in the collagen content of the treated fibroids. On March 12, 2018, we announced the presentation of interim data from our ongoing Phase 1 clinical trial of XIALEX for the treatment of uterine fibroids at the 65th Annual Scientific Meeting of the Society for Reproductive Investigation on Friday, March 9, 2018 in San Diego, CA. The data showed the safety and effectiveness of the XIALFEX injection method in five patients.

Outlook

We generated revenue from primarily one source, the License Agreement.  Under the License Agreement, we receive license, sublicense income, royalties, milestones and mark-up on cost of goods sold payments related to the sale, regulatory submissions and approval of XIAFLEX as described above.

Significant Risks

We are dependent to a significant extent on third parties, and our principal licensee, Endo, may not be able to continue successfully commercializing XIAFLEX for Dupuytren’s contracture and Peyronie’s disease, 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.

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, municipal bonds and corporate bonds.

For more information regarding the risks facing the Company, please see the risk factors discussed under the heading “Risk Factors” under item 1A of Part 1 of our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on March 14, 2018 and under Item 1A of Part 2 of our Quarterly Report on Form 10Q for the quarter ended March 31, 2018 filed with the SEC on May 10, 2018.

Critical Accounting Policies, Estimates and Assumptions

The preparation of condensed 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 condensed 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 financial information at June 30, 2018 and for the three and six months ended June 30, 2018 and 2017 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, 2017 balance sheet amounts and disclosures included herein have been derived from the Company’s December 31, 2017 audited consolidated financial statements. The interim results are not necessarily indicative of results to be expected for the full fiscal year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2017 included in the Company’s Annual Report on Form 10-K filed and with the unaudited condensed consolidated financial statements included in our Quarterly Report on Form 10-Q for the first quarter of 2018 filed with the SEC. While our significant accounting policies are described in more detail in the notes to our unaudited condensed consolidated financial statements, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our unaudited condensed 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.
 
Except as described in Note 2 to our accompanying Condensed Consolidated Financial Statements with respect to changes in our revenue recognition policy related to our adoption of the requirements of ASC 606, there have been no significant changes to our critical accounting policies and estimates during the three and six months ended June 30, 2018, compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2017 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018.
 
Reimbursable Third-Party Patent Costs

We accrue patent costs that are reimbursable to Endo by us under the License Agreement. We capitalize certain patent costs related to patent prosecution and maintenance and expense others. As of June 30, 2018 and December 31, 2017, our net reimbursable third party patent expense was $49,000 and zero, respectively.
 
Receivables

At June 30, 2018 and December 31, 2017 our accounts receivable balance which consists of royalties and a mark-up on costs of goods sold, was $12.9 million and $4.7 million, respectively, and was from one customer, Endo.

Deferred Revenue

We recognized the remaining $35,000 related to nonrefundable upfront product license fees for product candidates as there were no remaining performance obligations. In addition, we determined that the $100,000 related to a milestone payment withheld by Endo due to a foreign tax withholding was uncollectable and have reduced this amount to zero. As of June 30, 2018 and December 31, 2017, deferred revenue was zero and $6.4 million, respectively.

Third-Party Royalties

We have entered into licensing and royalty agreements with third parties and agreed to pay certain royalties on net sales of products for specific indications. The royalty rates differ from agreement to agreement and, in certain cases, have been redacted with the permission of the SEC.  No assumptions should be made that any disclosed royalty rate payable to a particular third party is the same or similar with respect to any royalty rate payable to any other third parties.  We accrue third-party royalty expenses on net sales reported to us by Endo. Third-party royalty costs are generally expensed under general and administrative in the quarter that the net sales have occurred. For the three and six month periods ended June 30, 2018, third-party royalty expenses were $0.5 million and $1.0 million, respectively. For the three and six month periods ended June 30, 2017, third-party royalty expenses were $0.4 million and $0.9 million, respectively. Our third-party royalty expense under general and administrative expenses may increase if net sales by Endo and its partners for XIAFLEX and Xiapex increase and potential new indications for XIAFLEX and Xiapex are approved, marketed and sold.

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 in connection with 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 of $600,000, all of which have been paid as of June 30, 2018.  Royalty obligations terminate five years after first commercial sale which occurred in January 2014. The Company amortizes long-term contracts with finite lives in a manner that reflects the pattern in which the economic benefits of the assets are consumed or otherwise used up. Dr. Gelbard’s agreement is amortized based on an income forecast method by estimating sales of XIAFLEX and Xiapex for Peyronie’s disease on an annual basis as measured by the proportion of the total estimated sales over the five year period. For the three and six months ended June 30, 2018 and 2017, we amortized approximately $0.5 million and $1.0 million related to this agreement, respectively and $0.4 million and $0.7 million for the three and six months ended June 30, 2017. As of June 30, 2018 and December 31, 2017, the remaining capitalized balances were approximately $1.1 million and $2.5 million, respectively. We perform an evaluation of the recoverability of the carrying value to determine if facts and circumstances indicate that the carrying value of the assets may be impaired and if any adjustment is warranted.  As of June 30, 2018, there was no indicator that an impairment existed.
 
Stock Based Compensation

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

RESULTS OF OPERATIONS

THREE MONTHS ENDED JUNE 30, 2018 COMPARED TO THREE MONTHS ENDED JUNE 30, 2017

Revenues

Royalties

Royalties consist of royalties and the mark-up on cost of goods sold under the License Agreement. Total royalty and mark-up on cost of goods sold for the three month period ended June 30, 2018 were $7.1 million as compared to $6.5 million in the corresponding 2017 period, an increase of $0.6 million or 9%. The increase in total revenues for the quarterly period was primarily due to royalties associated with higher net sales of XIAFLEX in Peyronies disease partially offset by lower mark-up on cost of goods sold revenue in prepaid foreign mark-up on cost of goods sold revenue recognized under new revenue standard ASC 606, as of January 1, 2018.

Licensing Revenue
 
Licensing revenue consists of licensing fees, sublicensing fees and milestones. For the three month periods ended June 30, 2018, we recognized the remaining $35,270 related to nonrefundable upfront product license fees for product candidates as there were no remaining performance obligations as compared to $4,409 in the 2017 period.
 
Milestone revenue recognized for the three months ended June 30, 2018 and 2017 was zero in each period.
 
Research and Development Activities and Expenses
 
R&D expenses include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expenses, 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. For the three month periods ended June 30, 2018 and 2017, R&D expenses were approximately $0.2 million and $0.3 million, respectively and in each case, are primarily related to the development work associated with our clinical, preclinical and other R&D programs. The decrease in the 2018 period as compare to the 2017 period was mainly due to lower consulting fees associated with clinical, preclinical and other R&D programs.

We manage the development of XIAFLEX for uterine fibroids and initiate the development of XIAFLEX in new potential indications, not licensed by Endo. On April 18, 2017, we announced the initiation of an open-label, dose escalation Phase 1 clinical trial of XIAFLEX for the treatment of uterine fibroids. On March 12, 2018, we announced the presentation of data that shows the safety and effectiveness of the XIALFELX injection method in five patients.
 
The following table summarizes our R&D expenses related to our development programs:

   
Three Months Ended
June 30, 2018
   
Three Months Ended
June 30, 2017
 
Program
           
Uterine Fibroids
 
$
104,596
   
$
107,746
 
Pre-clinical/other research projects
   
107,200
     
229,985
 

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

We believe that our current resources and liquidity are sufficient to advance our current clinical and R&D projects.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and other related costs for personnel, third-party royalty fees, amortization of deferred royalty buy-down, consultant costs, legal fees, investor relations, professional fees and overhead costs. General and administrative expenses for the three months ended June 30, 2018 and 2017 were $2.0 million and $2.3 million, respectively. The decrease in general and administrative expenses was mainly due to the lower consulting and patent fees partially offset by higher amortization associated with deferred royalty buy-down and third party royalties associated with XIAFLEX.
 
Other Income

Other income for the three months ended June 30, 2018 was approximately $356,000 compared to $164,000 in the corresponding 2017 period. Other income consists of interest earned on our investments and product sales of collagenase for laboratory use.
 
Provision for Income Taxes
 
Our deferred tax liabilities and deferred tax assets are impacted by events and transactions arising in the ordinary course of business, R&D activities, vesting of nonqualified options, deferred revenues and other items. For the three month period ended June 30, 2018, our provision for income taxes was $1.0 million. Our deferred tax assets as of June 30, 2018 were $0.3 million. The estimated effective tax rate for the three months ended June 30, 2018 was 18.2% of pre-tax income reported in the period, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2018 plus the effects of certain discrete items occurring in 2018. Our effective tax rate for the three months ended June 30, 2018 was impacted primarily by the Tax Cuts and Jobs Act of 2017, which was enacted on December 22, 2017 and lowered the U.S. corporate tax rate from 35% to 21%, beginning in 2018. Our effective tax rate was also impacted by the discrete impact of current period stock option exercises which impacts the effective rate in the period in which it occurs.
 
For the three month period ended June 30, 2017, the provision for income taxes was $1.4 million. The effective tax rate for the three months ended June 30, 2017 was 34.8% of pre-tax income reported in the period, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2017 plus the effects of certain material discrete items that occurred in 2017.
 
Net Income

For the three months ended June 30, 2018, we recorded net income of $4.3 million, or $0.60 per basic common share and $0.59 per diluted common share, compared to a net income of $2.6 million, or $0.37 per basic common share and $0.36 per diluted common share, for the same period in 2017.
 
SIX MONTHS ENDED JUNE 30, 2018 COMPARED TO SIX MONTHS ENDED JUNE 30, 2017

Revenues

Royalties

Royalties consist of royalties and the mark-up on cost of goods sold under the License Agreement. Total royalty and mark-up on cost of goods sold for the six month period ended June 30, 2018 were $14.1 million as compared to $14.2 million in the corresponding 2017 period, a decrease of $0.1 million or 1%. The decrease in total revenues for the quarterly period was primarily due to lower mark-up on cost of goods sold revenue in the U.S and prepaid foreign mark-up on cost of goods sold revenue recognized under new revenue standard ASC 606, as of January 1, 2018, which was mostly offset by an increase in royalties associated with higher overall net sales of XIAFLEX in Peyronies disease.

Licensing Revenue
 
Licensing revenue consists of licensing fees, sublicensing fees and milestones. We recognized certain licensing fees related to the cash payments received under the License Agreement in prior years and amortized them over the expected development period. For the six month periods ended June 30, 2018, we recognized the remaining $39,679 related to nonrefundable upfront product license fees for product candidates as there were no remaining performance obligations as compared to $8,818 in the 2017 period.
 
Milestone revenue recognized for the six months ended June 30, 2018 and 2017 was zero in each period.
 
Research and Development Activities and Expenses
 
R&D expenses include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expenses, 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. For the three month periods ended June 30, 2018 and 2017, R&D expenses were approximately $0.4 million and $0.6 million, respectively and in each case, are primarily related to the development work associated with our clinical, preclinical and other R&D programs. The decrease in the 2018 period as compare to the 2017 period was mainly due to lower consulting fees associated with clinical, preclinical and other R&D programs.

We manage the development of XIAFLEX for uterine fibroids and initiate the development of XIAFLEX in new potential indications, not licensed by Endo. On April 18, 2017, we announced the initiation of an open-label, dose escalation Phase 1 clinical trial of XIAFLEX for the treatment of uterine fibroids. On March 12, 2018, we announced the presentation of data that shows the safety and effectiveness of the XIALFELX injection method in five patients.

The following table summarizes our R&D expenses related to our development programs:

   
Six Months Ended
June 30, 2018
   
Six Months Ended
June 30, 2017
 
Program
           
Uterine Fibroids
 
$
127,534
   
$
228,132
 
Pre-clinical/other research projects
   
279,489
     
364,380
 
 
The successful development of drugs is inherently difficult and uncertain.  Our business requires investments in R&D over many years, often for drug candidates that may fail during the R&D process. Even if the Company is able to successfully complete the development of our drug candidates, our long-term prospects depend upon our ability and the ability of our partners, particularly with respect to XIAFLEX and Xiapex, to continue to 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 R&D 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.

We believe that our current resources and liquidity are sufficient to advance our current clinical and R&D projects.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and other related costs for personnel, third-party royalty fees, amortization of deferred royalty buy-down, consultant costs, legal fees, investor relations, professional fees and overhead costs. General and administrative expenses for the six months ended June 30, 2018 and 2017 were $4.1 million and $4.7 million, respectively. The decrease in general and administrative expenses was mainly due to the lower consulting and patent fees partially offset by higher amortization associated with deferred royalty buy-down and third party royalties associated with XIAFLEX.

Other Income

Other income for the six months ended June 30, 2018 was approximately $0.6 million compared to $0.3 million in the corresponding 2017 period. Other income consists of interest earned on our investments and product sales of collagenase for laboratory use.

Provision for Income Taxes

Our deferred tax liabilities and deferred tax assets are impacted by events and transactions arising in the ordinary course of business, R&D activities, vesting of nonqualified options, deferred revenues and other items. For the six month period ended June 30, 2018, our provision for income taxes was $2.0 million. Our deferred tax assets as of June 30, 2018 were $0.3 million. The estimated effective tax rate for the six months ended June 30, 2018 was 19.7% of pre-tax income reported in the period, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2018 plus the effects of certain discrete items occurring in 2018. Our effective tax rate for the six months ended June 30, 2018 was impacted primarily by the Tax Cuts and Jobs Act of 2017, which was enacted on December 22, 2017 and lowered the U.S. corporate tax rate from 35% to 21%, beginning in 2018. Our effective tax rate was also impacted by the discrete impact of current period stock option exercises which impacts the effective rate in the period in which it occurs.

For the six month period ended June 30, 2017, the provision for income taxes was $3.2 million. The effective tax rate for the six months ended June 30, 2017 was 34.8% of pre-tax income reported in the period, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2017 plus the effects of certain material discrete items that occurred in 2017.
 
Net Income

For the six months ended June 30, 2018, we recorded net income of $8.3 million, or $1.15 per basic common share and $1.13 per diluted common share, compared to a net income of $6.0 million, or $0.83 per basic common share and $0.81 per diluted common share, for the same period in 2017.

Liquidity and Capital Resources

To date, we have financed our operations primarily through product sales, licensing revenues and royalties under agreements with third parties and sales of our common stock. At June 30, 2018 and December 31, 2017, we had cash and cash equivalents and investments in the aggregate of approximately $73.7 million and $65.1 million, respectively. We currently anticipate that our available funds and cash flow from operations will be sufficient to meet our operational cash needs for at least the next 12 months from the date of this filing.

Net cash provided by operating activities for the six months ended June 30, 2018 was $8.1 million as compared to net cash provided by operating activities of $6.3 million in the 2017 period. Net cash provided by operating activities in the 2018 period was primarily attributable to our net income partially offset by an increase in accounts receivable of $0.7 million due to the timing of Endo’s payment of our quarterly XIAFLEX royalties and accrued tax liability of $0.6 million.  Non-cash items included amortization, stock-based compensation expense, and deferred taxes which was reduced by adjustments to reconcile net income to net cash provided by operating activities of $1.5 million. Net cash provided by operating activities in the 2017 period was primarily attributable to our net income of $6.0 million, an increase in operating assets and liabilities of $1.0 million of which $0.9 million was related to an increase in accounts receivable due to sales of XIAFLEX. Non-cash items included amortization, stock-based compensation expense, and deferred taxes which was reduced by adjustments to reconcile net income to net cash provided by operating activities of $1.4 million.
 
Net cash used in investing activities for the six months ended June 30, 2018 was $3.3 million as compared to $4.8 million for the corresponding 2017 period. The net cash used in investing activities in the 2018 period reflects the investment of $40.6 million and the maturing of $37.3 million in marketable securities. The net cash used in investing activities in the 2017 period reflects the investment of $37.7 million and the maturing of $32.9 million marketable securities.

Net cash provided by financing activities for the six months ended June 30, 2018 was approximately $0.9 million as compared to net cash used in financing activities of approximately $0.2 million in the corresponding 2017 period. In the 2018 period, net cash provided by financing activities was due to proceeds received from stock option exercises. In the 2017 period, net cash used in financing activities was mainly due to the repurchase of approximately $0.5 million of our common stock under our stock repurchase program partially offset by the proceeds received from stock option exercises of approximately $0.3 million.

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, investments, trade accounts receivable, accounts payable and long-term obligations. We consider investments that, when purchased, have a remaining maturity of three months or less to be cash equivalents.

Our investment portfolio is subject to interest rate risk, although limited given the short term nature of the investments, and will fall in value in the event market interest rates increase. All of our cash and cash equivalents and investments at June 30, 2018, amounting to approximately $73.7 million, were maintained in bank demand accounts, money market accounts, certificates of deposit, corporate bonds and municipal bonds. 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 June 30, 2018.

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 Quarterly Report on Form 10-Q. Based on that evaluation, Thomas L. Wegman, in his capacity as the sole named executive officer of the Company, the Company’s Principal Executive Officer and the Company’s Principal Financial Officer, concluded that the Company’s disclosure controls and procedures are effective to ensure that information required to be disclosed by it in reports the Company files or submits 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 material information is accumulated and communicated to the Company’s management, including its Principal Executive Officer and Principal Financial Officer, 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, the Company’s 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 such 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 control over financial reporting (as defined in Rules 13a–15(f) and 15d–15(f) under the Exchange Act) that occurred during the three months ended June 30, 2018 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

In addition to the other information contained elsewhere in this Report, you should carefully consider the risk factors discussed in “Part I, Item 1A. Risk Factors” our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on March 14, 2018 and our Quarterly Report on Form 10-Q for the first quarter of 2018 filed with the SEC on May 10, 2018, which could materially affect our business, financial condition or future results.

Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
 
During the six month period ended June 30, 2018, we did not issue any unregistered shares of securities.

Issuer Purchases of Equity Securities

During the six month period ended June 30, 2018, we did not repurchase any of our securities.
 
Item 6.
Exhibits
 
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule13a-14(a)/15d-14(a).
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of Sarbanes-Oxley Act of 2002.
101*
The following materials from BioSpecifics Technologies Corp.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, (i) the Condensed Consolidated Statements of Operations, (ii) the Condensed Consolidated Statements of Cash Flows, and (iii) the Notes to the Condensed Consolidated Financial Statements.
 

* filed herewith
** furnished 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, 2018
/s/ Thomas L. Wegman
 
Thomas L. Wegman
 
President, Principal Executive Officer and
Principal Financial Officer
 
 
29

EX-31 2 ex31.htm EXHIBIT 31

Exhibit 31

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

I, Thomas L. Wegman, certify that:

1.
I have reviewed this report on Form 10-Q for the quarterly period ended June 30, 2018 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 officer(s) 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 officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and 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, 2018

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

EX-32 3 ex32.htm EXHIBIT 32

Exhibit 32

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER
 PURSUANT TO RULES 13a-14(b) AND 15d-14(b) OF
 THE SECURITIES EXCHANGE ACT OF 1934 AND
 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

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

1.
The Company’s report on Form 10-Q for the quarterly period ended June 30, 2018 (the “Report”), fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”); 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 2018.

/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 Exchange Act or otherwise subject to liability pursuant to that section. Such certification shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent that the Company specifically incorporates it by reference.

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

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font-family: 'Times New Roman'; font-weight: bold; text-align: right;">53,585,924</div></td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; padding-bottom: 4px; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; padding-bottom: 4px; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; border-bottom: #000000 4px double; text-align: left; background-color: #ffffff;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;">$</div></td><td valign="bottom" style="width: 9%; vertical-align: bottom; border-bottom: #000000 4px double; text-align: right; background-color: #ffffff;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: right;">7,163,483</div></td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; padding-bottom: 4px; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; 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font-family: 'Times New Roman'; font-weight: bold;">$</div></td><td valign="bottom" style="width: 9%; vertical-align: bottom; border-bottom: #000000 4px double; text-align: right; background-color: #ffffff;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;">5,745,974</div></td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; padding-bottom: 4px; text-align: left; background-color: #ffffff;">&#160;</td></tr></table><div>&#160;</div></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">The authoritative literature for fair value measurements established a three-tier fair value hierarchy, which prioritizes the inputs in measuring fair value. 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vertical-align: top; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 20%; vertical-align: top; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 9%; vertical-align: bottom; text-align: right; background-color: #ffffff;">&#160;</td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 9%; vertical-align: bottom; text-align: right; background-color: #ffffff;">&#160;</td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 9%; vertical-align: bottom; text-align: right; background-color: #ffffff;">&#160;</td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td><td valign="bottom" style="width: 9%; vertical-align: bottom; text-align: right; background-color: #ffffff;">&#160;</td><td nowrap="nowrap" valign="bottom" style="width: 1%; vertical-align: bottom; text-align: left; background-color: #ffffff;">&#160;</td></tr><tr><td valign="bottom" style="width: 21%; 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The new guidance will impact the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. All equity investments in unconsolidated entities (other than those accounted for under the equity method of accounting) will generally be measured at fair value with changes in fair value recognized through earnings. There will no longer be an available-for-sale classification (changes in fair value reported in other comprehensive income (loss) for equity securities with readily determinable fair values). In addition, the FASB clarified the need for a valuation allowance on deferred tax assets resulting from unrealized losses on available-for-sale debt securities. In general, the new guidance will require modified retrospective application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings. The adoption of the new standard as of January 1, 2018 had no impact on our consolidated financial statements and related disclosure as we do not currently have any available-for-sale equity investments.</div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">&#160;</div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; text-align: justify; text-indent: 36pt;">Accounting Pronouncements Not Yet Adopted</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;"><font style="font-size: 10pt; font-family: 'Times New Roman'; background-color: #ffffff;">In February 2016, FASB issued Accounting Standards Update (ASU) No. 2016-02, </font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; background-color: #ffffff;">Leases (Topic 842)</font><font style="font-size: 10pt; font-family: 'Times New Roman'; background-color: #ffffff;"> (&#8220;ASU 2016-02&#8221;)</font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; background-color: #ffffff;">. </font><font style="font-size: 10pt; font-family: 'Times New Roman'; background-color: #ffffff;">Under the new guidance, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the lease commencement date: a lease liability, which is a lessee&#8217;s obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee&#8217;s right to use, or control the use of, a specified asset for the lease term. Under the new guidance, lessor accounting is largely unchanged. Certain targeted improvements were made to align, where necessary, lessor accounting with the lessee accounting model and Topic 606, </font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; background-color: #ffffff;">Revenue from Contracts with Customers</font><font style="font-size: 10pt; font-family: 'Times New Roman'; background-color: #ffffff;">. The new lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. Lessees will no longer be provided with a source of off-balance sheet financing. Public business entities should apply the amendments in ASU 2016-02 for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years (i.e., January 1, 2019, for a calendar year entity). Early application is permitted.&#160; Lessees (for capital and operating leases) and lessors (for sales-type, direct financing, and operating leases) must apply a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. Lessees and lessors may not apply a full retrospective transition approach.</font> We are currently evaluating the&#160;impact that the standard could have on our consolidated financial statements and related disclosures.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">In June 2016, FASB issued ASU 2016-13, <font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic;">Financial Instruments - Credit Losses</font>. The amendment revises the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in more timely recognition of losses on financial instruments, including, but not limited to, available for sale debt securities and accounts receivable. The Company is required to adopt this standard starting in the first quarter of fiscal year 2021. Early adoption is permitted. We are currently evaluating the impact of the adoption of this standard on our consolidated financial statements and related disclosures.</div></div> 164418 355731 268733 588360 3882502 9723950 8892623 4899401 <div style="font-family: 'Times New Roman'; font-size: 10pt;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: justify;">1. ORGANIZATION AND DESCRIPTION OF BUSINESS</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">We are a biopharmaceutical company involved in the development of an injectable collagenase clostridium histolyticum for multiple indications. We currently have a development and license agreement with Endo Global Ventures, a Bermuda unlimited liability company (<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8220;</font>Endo Global Ventures<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8221;</font>), an affiliate of Endo International plc (<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8220;</font>Endo<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8221;</font>), for injectable collagenase for marketed indications and indications in development. Endo assumed this agreement when Endo acquired Auxilium Pharmaceuticals, Inc. (<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8220;</font>Auxilium<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8221;</font>) on January 29, 2015 (the <font style="font-size: 10pt; font-family: 'Times New Roman';">&#8220;</font>Acquisition<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8221;</font>). Injectable collagenase clostridium histolyticum is marketed as XIAFLEX<font style="font-size: 10pt; font-family: 'Times New Roman';">&#174;</font> (or Xiapex<font style="font-size: 10pt; font-family: 'Times New Roman';">&#174;</font> in Europe).</div><div style="text-align: justify;"><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">On February 1, 2016, we entered into with Endo the First Amendment (the <font style="font-size: 10pt; font-family: 'Times New Roman';">&#8220;</font>First Amendment<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8221;</font>) to the Second Amended and Restated Development and Licensing Agreement (the <font style="font-size: 10pt; font-family: 'Times New Roman';">&#8220;</font>Auxilium Agreement<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8221;</font>), by and between us and Auxilium, now a wholly-owned subsidiary of Endo, to amend certain provisions of the Auxilium Agreement (as amended by the First Amendment, the <font style="font-size: 10pt; font-family: 'Times New Roman';">&#8220;</font>License Agreement<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8221;</font>). The effective date of the First Amendment was January 1, 2016. Pursuant to the First Amendment, we and Endo mutually agreed that in exchange for a $8.25 million lump sum payment, we will not receive future additional mark-up on cost of goods sold for sales by non-affiliated sublicensees of Endo outside of the U.S.; provided, however, that Endo will still be required to pay a mark-up on cost of goods sold for sales made in the <font style="font-size: 10pt; font-family: 'Times New Roman';">&#8220;</font>Endo Territory,<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8221;</font> which includes sales made in the U.S. and sales made in any other country where Endo sells the product directly or through affiliated sublicensees.</div><div style="text-align: justify;"><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">Additionally, we agreed that Endo may opt-in early to indications, prior to our submission of a clinical trial report, with our consent, such consent not to be unreasonably withheld. For early opt-ins, Endo will be required to make an opt-in payment of $0.5 million on a per indication basis. For regular opt-ins, following our submission of a clinical trial report, Endo will be required to make an opt-in payment of $0.75 million on a per indication basis.</div><div style="text-align: justify;"><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">The two marketed indications involving our injectable collagenase are Dupuytren<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8217;</font>s contracture and Peyronie<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8217;</font>s disease. Prior to the Acquisition, Auxilium had, and after the Acquisition, Endo has, opted-in to the following indications: frozen shoulder, cellulite, canine lipoma, lateral hip fat, plantar fibromatosis and human lipoma. Endo exercised, with our consent, an early opt-in for lateral hip fat and plantar fibromatosis in November 2015. Endo opted-in for human lipoma in July 2016. We manage the development of XIAFLEX for uterine fibroids and initiate the development of XIAFLEX in new potential indications, not licensed by Endo.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;"><font style="font-size: 10pt; font-family: 'Times New Roman';">On November 8, 2016, following a change in Endo management, Endo announced that a commercial review is ongoing of the XIAFLEX exercised but non-marketed indications, including frozen shoulder, cellulite, lateral hip fat, plantar fibromatosis and human lipoma, so that Endo can best prioritize its R&amp;D efforts and determine clinical trial timelines moving forward. </font>On February 6, 2018, Endo initiated two identical Phase 3 RELEASE clinical trials of XIAFLEX for the treatment of cellulite. The multicenter, randomized, double-blind, placebo-controlled RELEASE studies will evaluate the safety and efficacy of XIAFLEX in reducing the appearance of cellulite.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">Endo is currently selling XIAFLEX in the U.S. for the treatment of Dupuytren<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8217;</font>s contracture and Peyronie<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8217;</font>s disease and has an agreement with Swedish Orphan Biovitrum AB (<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8220;</font>Sobi<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8221;</font>), pursuant to which Sobi has marketing rights for Xiapex for Dupuytren<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8217;</font>s contracture and Peyronie<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8217;</font>s disease in Europe and certain Eurasian countries. Sobi is currently selling Xiapex in Europe and certain Eurasian countries for the treatment of Dupuytren<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8217;</font>s contracture and Peyronie<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8217;</font>s disease. In addition, Endo has an agreement with Asahi Kasei Pharma Corporation (<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8220;</font>Asahi<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8221;</font>) pursuant to which Asahi has the right to commercialize XIAFLEX for the treatment of Dupuytren<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8217;</font>s contracture and Peyronie<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8217;</font>s disease in Japan. Asahi is selling XIAFLEX for the treatment of Dupuytren<font style="font-size: 10pt; font-family: 'Times New Roman';">&#8217;</font>s contracture in Japan. <font style="font-size: 10pt; font-family: 'Times New Roman';">Endo is currently distributing XIAFLEX in Canada through Paladin Labs Inc., </font><font style="font-size: 10pt; font-family: 'Times New Roman'; background-color: #ffffff;">an operating company of Endo</font><font style="font-size: 10pt; font-family: 'Times New Roman';">. In December 2016, Endo entered into a new out-licensing agreement with Actelion Pharmaceuticals Ltd. (&#8220;Actelion&#8221;), pursuant to which Actelion obtained marketing and commercial rights for XIAFLEX in Australia and New Zealand.</font></div></div> 23423 96663 25985 81985 86232 136877 0 0 0 0 478762 0 40596520 37669248 0.50 0.50 700000 700000 0 0 0 0 623503 836979 37279000 32855741 258250 860050 258000 860000 P10Y P5Y <div style="font-family: 'Times New Roman'; font-size: 10pt;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: justify;">Property and Equipment</div><div style="text-align: justify;"><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">Property and equipment are stated at cost, less accumulated depreciation. Machinery and equipment, furniture and fixtures, and autos are depreciated on a straight-line basis over their estimated useful lives of five to ten years. Leasehold improvements are amortized over the lesser of their estimated useful lives or the remaining life of the lease. At each of June 30, 2018 and December 31, 2017, property and equipment were fully depreciated.</div></div> 100000 <div style="font-family: 'Times New Roman'; font-size: 10pt;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: justify;">Research and Development Expenses</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;"><font style="font-size: 10pt; font-family: 'Times New Roman';">R&amp;D expenses </font>include, but are not limited to, internal costs, such as salaries and benefits, costs of materials, lab expense, facility costs and overhead. R&amp;D expenses also consist of third party costs, such as medical professional fees, product costs used in clinical trials, consulting fees and costs associated with clinical study arrangements. We may fund R&amp;D at medical research institutions under agreements that are generally cancelable. All of these costs are charged to R&amp;D as incurred, which may be measured by percentage of completion, contract milestones, patient enrollment, or the passage of time.</div></div> 592512 337731 407023 211796 60402721 41939115 7400000 -2900000 10300000 9700000 50700000 14226135 7061139 14146139 39679 6535516 14217317 35270 8818 6531107 14185818 7096409 4409 -200000 -800000 15000000 7300000 14146139 14217317 7061139 6531107 <div style="font-family: 'Times New Roman'; font-size: 10pt;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: justify;">Revenue Recognition</div><div style="background-color: #ffffff;"><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">Beginning in 2014, Financial Accounting Standards Board (&#8220;FASB&#8221;) issued several Accounting Standards Updates establishing ASC Topic 606, &#8220;Revenue from Contracts with Customers&#8221; (&#8220;ASC 606&#8221;).&#160; ASC 606 requires retrospective implementation, and replaces most industry-specific revenue recognition guidance in U.S. GAAP with a new principles-based, five-step revenue recognition model.&#160; The Company adopted ASC 606 effective January 1, 2018. Under ASC 606, we recognize revenues when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. We recognize revenues following the five step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligation(s).</div><div style="text-align: justify;"><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">Revenues, and their respective treatment for financial reporting purposes under ASC 606 and our license agreement with Endo, are as follows:</div><div style="text-align: justify;"><br /></div></div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; text-align: justify; background-color: #ffffff; text-indent: 36pt;">Royalty / Mark-Up on Cost of Goods Sold</div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; text-align: justify; background-color: #ffffff;">&#160;</div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-style: normal; text-align: justify; background-color: #ffffff;">We receive royalty revenues on net sales and mark-up on cost of goods sold revenue in the U.S. under our License Agreement with Endo. These are presented in &#8220;Royalties&#8221; in our condensed consolidated statements of income.&#160; We do not have future performance obligations under this revenue stream. In accordance with ASC 606, we record these revenues based on estimates of the net sales that occurred during the relevant period. The relevant period estimates of these royalties are based on interim data provided by Endo (when available) and analysis of historical royalties and mark-up on cost of goods sold revenue that have been paid to us, adjusted for any changes in facts and circumstances, as appropriate. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known, typically the following quarter. The royalties payable by Endo to us are subject to set-off for certain patent costs.</div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; text-align: justify; background-color: #ffffff;">&#160;</div><div style="background-color: #ffffff;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; text-align: justify; margin-left: 36pt;">Licensing Revenue</div><div style="text-align: justify;"><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">We include revenue recognized from upfront licensing, sublicensing and milestone payments in &#8220;License Revenues&#8221; in our condensed consolidated statements of income.</div></div><div style="text-align: left; background-color: #ffffff;"><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify; background-color: #ffffff;">The Company recognizes licensing revenues generated through development and/or commercialization agreements. The terms of these agreements typically include payment to the Company of one or more of the following: nonrefundable, upfront license fees; sublicensing; development and commercial milestone payments; development activities; and royalties on net sales of licensed products. Each of these types of payments results in licensing revenues except for revenues from royalties on net sales of licensed products and the mark-up of cost of goods sold revenues which are classified as royalty revenues. Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the customer.</div><div style="text-align: left; background-color: #ffffff; text-indent: 18pt;"><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify; background-color: #ffffff;">For each development and/or commercialization agreement that result in revenues, the Company identifies all performance obligations, aside from those that are immaterial which may include a license to intellectual property and know-how, development activities and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company&#8217;s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.</div><div style="text-align: left; background-color: #ffffff;"><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify; background-color: #ffffff;">If a license to the Company&#8217;s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, upfront license fees based on the relative standalone selling price prescribed to the license compared to the total value of the arrangement. The revenue is recognized when the license is transferred to the collaborator and the collaborator is able to use and benefit from the license.&#160; For licenses that are not distinct from other obligations identified in the arrangement, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, the Company applies an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees.&#160; The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.</div><div style="text-align: left; background-color: #ffffff;"><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; text-align: left; background-color: #ffffff; text-indent: 36pt;">Development and Regulatory Milestone Payments</div><div style="text-align: left; background-color: #ffffff;"><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify; background-color: #ffffff;">Depending on facts and circumstances, the Company may conclude that it is appropriate to include the milestone, representing variable consideration, in the estimated total transaction price, or that it is appropriate to fully constrain the milestone. The Company may include revenues from certain milestones in the total transaction price in a reporting period before the milestone is achieved if the Company concludes that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods. The Company records a corresponding contract asset when this conclusion is reached. Milestone payments that have not been included in the transaction price to date are fully constrained. The Company re-evaluates the probability of achievement of such development milestones and any related constraint each reporting period. 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Accounting Standards Codification 718, <font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic;">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 stock options including stock options and common stock issued to our employees and directors under our stock plans. ASC 718 requires companies to estimate the fair value of stock option awards on the date of grant using an option-pricing model. 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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="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">The information included in this Report should be read in conjunction with the risk factors discussed in Part I, Item 1A. 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The new guidance will impact the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. All equity investments in unconsolidated entities (other than those accounted for under the equity method of accounting) will generally be measured at fair value with changes in fair value recognized through earnings. There will no longer be an available-for-sale classification (changes in fair value reported in other comprehensive income (loss) for equity securities with readily determinable fair values). In addition, the FASB clarified the need for a valuation allowance on deferred tax assets resulting from unrealized losses on available-for-sale debt securities. In general, the new guidance will require modified retrospective application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings. The adoption of the new standard as of January 1, 2018 had no impact on our consolidated financial statements and related disclosure as we do not currently have any available-for-sale equity investments.</div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">&#160;</div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; text-align: justify; text-indent: 36pt;">Accounting Pronouncements Not Yet Adopted</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;"><font style="font-size: 10pt; font-family: 'Times New Roman'; background-color: #ffffff;">In February 2016, FASB issued Accounting Standards Update (ASU) No. 2016-02, </font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; background-color: #ffffff;">Leases (Topic 842)</font><font style="font-size: 10pt; font-family: 'Times New Roman'; background-color: #ffffff;"> (&#8220;ASU 2016-02&#8221;)</font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; background-color: #ffffff;">. </font><font style="font-size: 10pt; font-family: 'Times New Roman'; background-color: #ffffff;">Under the new guidance, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the lease commencement date: a lease liability, which is a lessee&#8217;s obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee&#8217;s right to use, or control the use of, a specified asset for the lease term. Under the new guidance, lessor accounting is largely unchanged. Certain targeted improvements were made to align, where necessary, lessor accounting with the lessee accounting model and Topic 606, </font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic; background-color: #ffffff;">Revenue from Contracts with Customers</font><font style="font-size: 10pt; font-family: 'Times New Roman'; background-color: #ffffff;">. The new lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. Lessees will no longer be provided with a source of off-balance sheet financing. Public business entities should apply the amendments in ASU 2016-02 for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years (i.e., January 1, 2019, for a calendar year entity). Early application is permitted.&#160; Lessees (for capital and operating leases) and lessors (for sales-type, direct financing, and operating leases) must apply a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. Lessees and lessors may not apply a full retrospective transition approach.</font> We are currently evaluating the&#160;impact that the standard could have on our consolidated financial statements and related disclosures.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">In June 2016, FASB issued ASU 2016-13, <font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic;">Financial Instruments - Credit Losses</font>. The amendment revises the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in more timely recognition of losses on financial instruments, including, but not limited to, available for sale debt securities and accounts receivable. The Company is required to adopt this standard starting in the first quarter of fiscal year 2021. Early adoption is permitted. 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As of June 30, 2018 and December 31, 2017, the amortized cost of these investments was $60.7 million and $57.7 million, respectively. No unrealized gains or losses were recorded in either period.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: left;">Fair Value Measurements</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">Management believes that the carrying amounts of the Company&#8217;s financial instruments, including cash, cash equivalents, held to maturity investments, accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of those instruments. 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For the three and six months ended June 30, 2018, licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately $7.1 million and $14.2 million, respectively, and for the three and six months ended June 30, 2017, the licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately $6.5 million and $14.2 million, respectively.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">At June 30, 2018 and December 31, 2017, our accounts receivable balances from Endo were $12.9 million and $4.7 million, respectively.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: justify;">Treasury Stock</div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: justify;">&#160;</div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders&#8217; equity. 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As of June 30, 2018 and December 31, 2017, deferred revenue was zero and $6.4 million, respectively. <font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;">(</font>For more a more detailed discussion regarding ASC 606 see <font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;">Note 2</font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;">- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES</font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;"> - RECENT ACCOUNTING PRONOUNCEMENTS</font> - <font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic;">Accounting Pronouncements Adopted.</font><font style="font-size: 10pt; font-family: 'Times New Roman';">)</font></div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: justify;">Reimbursable Third-Party Patent Costs</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">We accrue patent costs that are reimbursable to Endo by us under the License Agreement. 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The royalty rates differ from agreement to agreement and, in certain cases, have been redacted with the permission of the SEC.&#160; No assumptions should be made that any disclosed royalty rate payable to a particular third party is the same or similar with respect to any royalty rate payable to any other third parties. We accrue third-party royalty expenses on net sales reported to us by Endo. Third-party royalty costs are generally expensed under general and administrative in the quarter that the net sales have occurred. For the three and six month periods ended June 30, 2018, third-party royalty expenses were $0.5 million and $1.0 million, respectively. For the three and six month periods ended June 30, 2017, third-party royalty expenses were $0.4 million and $0.9 million, respectively. 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For the three and six months ended June 30, 2018 and 2017, we amortized approximately $0.5 million and $1.0 million related to this agreement, respectively and $0.4 million and $0.7 million for the three and six months ended June 30, 2017. With the adoption of ASC 606 as of January 1, 2018 <font style="font-size: 10pt; font-family: 'Times New Roman';">using the modified-retrospective adoption method</font>, <font style="font-size: 10pt; font-family: 'Times New Roman';">we recorded an adjustment to our capitalized balance of $0.4 million related to royalties associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag</font>. As of June 30, 2018 and December 31, 2017, the remaining capitalized balances were approximately $1.1 million and $2.5 million, respectively. 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Accounting Standards Codification 718, <font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic;">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 stock options including stock options and common stock issued to our employees and directors under our stock plans. ASC 718 requires companies to estimate the fair value of stock option awards on the date of grant using an option-pricing model. 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The allocation of employee stock-based compensation costs to each operating expense line are estimated based on specific employee headcount information at each grant date and estimated stock option forfeiture rates and revised, if necessary, in future periods if actual employee headcount information or forfeitures differ materially from those estimates. 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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. </font>In accordance with Accounting Standards Codification 740-10-45-25, <font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic;">Income Statement Classification of Interest and Penalties</font>, we classify interest associated with income taxes under interest expense and tax penalties under other.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">The Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon the ultimate settlement. As of June 30, 2018 and December 31, 2017, the Company has not recorded any unrecognized tax benefits.</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: left;">Commitments and Contingencies</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">On November 6, 2017, the Company entered into an agreement with the Landlord to extend the term of the lease to the Headquarters for an additional one year period (the &#8220;Extended Lease Agreement&#8221;). The one year extension will end on November 30, 2018. 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We consider the following factors when determining the collectability of specific customer accounts: customer credit-worthiness, past transaction history with the customer, current economic industry trends, and changes in customer payment terms.&#160; Our accounts receivable balance is typically due from Endo, our one large specialty pharmaceutical customer.&#160; Endo has historically paid timely and has been a financially stable organization.&#160; Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.&#160; If the financial condition of our customer were to deteriorate, adversely affecting its ability to make payments, additional allowances would be required.&#160; We may provide for estimated uncollectible amounts through a charge to earnings and a credit to a valuation allowance. 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The Company makes certain assumptions and estimates for its revenues, deferred tax assets, third party royalties and deferred royalty buy-down. <font style="font-size: 10pt; font-family: 'Times New Roman';">We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and the amount of revenues and expenses. Actual results may differ from these estimates under different assumptions or conditions. </font>For further details, see notes &#8220;Revenue Recognition&#8221;, &#8220;Provision for Income Taxes&#8221; and &#8220;Third-Party Royalties and Royalty Buy-Down.&#8221; Actual results may differ from those estimates.</div></div> 7170223 7204040 7215057 7167251 7330875 7315276 7309325 7329118 500000 750000 0 78138 1 1 0 0 P0Y P0Y P0Y P3M 11165 1500000 600000 5 49000 0 P5Y 5 <div style="font-family: 'Times New Roman'; font-size: 10pt;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: justify;">Reimbursable Third-Party Patent Costs</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">We accrue patent costs that are reimbursable to Endo by us under the License Agreement. We capitalize certain patent costs related to patent prosecution and maintenance and expense others. As of June 30, 2018<font style="font-size: 10pt; font-family: 'Times New Roman';"> and December 31, 2017,</font> our net reimbursable third party patent expense was $49,000 and zero, respectively.</div></div> <div style="font-family: 'Times New Roman'; font-size: 10pt;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: justify;">Third-Party Royalties</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify; background-color: #ffffff;">We have entered into licensing and royalty agreements with third parties and agreed to pay certain royalties on net sales of products for specific indications. The royalty rates differ from agreement to agreement and, in certain cases, have been redacted with the permission of the SEC.&#160; No assumptions should be made that any disclosed royalty rate payable to a particular third party is the same or similar with respect to any royalty rate payable to any other third parties. We accrue third-party royalty expenses on net sales reported to us by Endo. Third-party royalty costs are generally expensed under general and administrative in the quarter that the net sales have occurred. For the three and six month periods ended June 30, 2018, third-party royalty expenses were $0.5 million and $1.0 million, respectively. For the three and six month periods ended June 30, 2017, third-party royalty expenses were $0.4 million and $0.9 million, respectively. With the adoption of ASC 606 as of January 1, 2018 <font style="font-size: 10pt; font-family: 'Times New Roman';">using the modified-retrospective adoption method</font>, <font style="font-size: 10pt; font-family: 'Times New Roman';">we recorded an adjustment to our retained earnings for third party royalties expense of $0.5 million associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag</font>. Our third-party royalty expense under general and administrative expenses may increase if net sales by Endo and its partners for XIAFLEX and Xiapex increase and potential new indications for XIAFLEX and Xiapex are approved, marketed and sold.<font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;"> (</font>For more a more detailed discussion regarding ASC 606 see <font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;">Note 2</font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;">- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES</font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;"> - RECENT ACCOUNTING PRONOUNCEMENTS</font> - <font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic;">Accounting Pronouncements Adopted.</font><font style="font-size: 10pt; font-family: 'Times New Roman';">)</font></div></div> <div style="font-family: 'Times New Roman'; font-size: 10pt;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: justify; background-color: #ffffff;">Royalty Buy-Down</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">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 in connection with Peyronie&#8217;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 of $600,000, all of which have been paid as of June 30, 2018.&#160; Royalty obligations terminate five years after first commercial sale which occurred in January 2014. The Company amortizes long-term contracts with finite lives in a manner that reflects the pattern in which the economic benefits of the assets are consumed or otherwise used up. Dr. Gelbard&#8217;s agreement is amortized based on an income forecast method by estimating sales of XIAFLEX and Xiapex for Peyronie&#8217;s disease on an annual basis as measured by the proportion of the total estimated sales over the five year period. For the three and six months ended June 30, 2018 and 2017, we amortized approximately $0.5 million and $1.0 million related to this agreement, respectively and $0.4 million and $0.7 million for the three and six months ended June 30, 2017. With the adoption of ASC 606 as of January 1, 2018 <font style="font-size: 10pt; font-family: 'Times New Roman';">using the modified-retrospective adoption method</font>, <font style="font-size: 10pt; font-family: 'Times New Roman';">we recorded an adjustment to our capitalized balance of $0.4 million related to royalties associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag</font>. As of June 30, 2018 and December 31, 2017, the remaining capitalized balances were approximately $1.1 million and $2.5 million, respectively. We perform an evaluation of the recoverability of the carrying value to determine if facts and circumstances indicate that the carrying value of the assets may be impaired and if any adjustment is warranted.&#160; As of June 30, 2018, there was no indicator that an impairment existed. <font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;">(</font>For more a more detailed discussion regarding ASC 606 see <font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;">Note 2</font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;">- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES</font><font style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold;"> - RECENT ACCOUNTING PRONOUNCEMENTS</font> - <font style="font-size: 10pt; font-family: 'Times New Roman'; font-style: italic;">Accounting Pronouncements Adopted.</font><font style="font-size: 10pt; font-family: 'Times New Roman';">)</font></div></div> <div style="font-family: 'Times New Roman'; font-size: 10pt;"><div style="font-size: 10pt; font-family: 'Times New Roman'; font-weight: bold; text-align: left;">Clinical Trial Expenses</div><div><br /></div><div style="font-size: 10pt; font-family: 'Times New Roman'; text-align: justify;">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 consultants. 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&#8217;s continued participation in the trial. In the event of early termination of a clinical trial, we accrue an amount based on our estimate of the remaining non-cancelable obligations associated with the winding down of the clinical trial. Our estimates and assumptions could differ significantly from the amounts that may actually be incurred.</div></div> -900000 -500000 -400000 As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion. This adjustment represents the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017. Represents the remaining deferred revenue balance of the prepaid mark-up on cost of goods sold based on sales by non-affiliated sublicensees of Endo outside of the U.S. Represents the amortization of the royalty buy-down and third party royalties expense associated royalty revenues based on XIALFLEX net sales reported to us by Endo for the fourth quarter of 2017. To reverse a deferred tax asset associated with the deferred revenue balance of the prepaid mark-up on cost of goods sold by non-affiliated sublicensees of Endo outside of the U.S. To create a tax liability associated the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017. 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POLICIES Significant Accounting Policies [Text Block] Condensed Consolidated Balance Sheets (unaudited) [Abstract] Balance Sheets [Abstract] Class of Stock [Axis] Statement [Line Items] Statement [Table] Condensed Consolidated Statements of Cash Flows (unaudited) [Abstract] Exercised (in shares) Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period Stock Options [Member] Equity Option [Member] Treasury Stock Stockholders' Equity, Policy [Policy Text Block] Total stockholders' equity Stockholders' Equity Attributable to Parent Stockholders' equity: Equity [Abstract] Supplemental disclosures of cash flow information: Income tax payable Receivables and Doubtful Accounts Treasury stock purchased (in shares) Treasury Stock, Shares, Acquired Treasury Stock [Abstract] Average price of share (in dollars per share) Treasury stock, 410,934 shares at cost as of June 30, 2018 and December 31, 2017 Treasury Stock, Value Treasury stock, shares (in shares) Type of Adoption [Domain] Unrecognized tax benefits Unrecognized Tax Benefits Interest and penalties Critical Accounting Policies, Estimates and Assumptions Use of Estimates, Policy [Policy Text Block] Shares used in computation of basic net income per share (in shares) Shares used in computation of diluted net income per share (in shares) Number of common equivalent shares included for the calculation of diluted net income [Abstract] Customers [Axis] Customer [Axis] Maximum [Member] Minimum [Member] Customer [Domain] Products and Services [Domain] Product and Service [Domain] Products and Services [Axis] Range [Domain] Range [Axis] Represents one of the major pharmaceutical customer of the entity from which a large part of revenue is generated. Endo [Member] The opt in fee receivable for each indication during the period. Opt in fee receivable for each indication Opt-in fee receivable for each indication The regular opt in fee receivable for each indication during the period. Regular Opt in Fee Receivable for Each Indication Regular opt-in fee receivable for each indication Revenue recognized from upfront licensing, sublicensing and milestone payments in "License Revenues". Licensing Revenues [Member] Royalty revenues earned on net sales and mark-up on cost of goods sold revenue in the U.S. under our License Agreement with Endo. Royalties [Member] Royalties [Member] Organization and Description of Entity [Abstract] Organization and Description of Business [Abstract] Patent Cost [Abstract] Patent Cost [Abstract] Cash paid during the year for [Abstract] Cash paid during the period for: The amount of accrued liabilities extinguished. Extinguishment of Accrued Liabilities Extinguishment of accrued liabilities Income Per Share, Net [Abstract] Net Income Per Share [Abstract] Refers to exercise price of option outstanding. Exercise Price Two [Member] Exercise Price of $29.21 [Member] Number of Customers from which Company is getting revenue is being generated. Number of Customers Number of customers Document and Entity Information [Abstract] Number of stock based compensation plans in effect for employees and directors. Number of stock based compensation plans in effect Number of stock based compensation plans A roll forward is a reconciliation of a concept from the beginning of a period to the end of a period. Share-based Compensation Arrangement by Share-based Payment Award, Options, Intrinsic Value [Roll Forward] Aggregate Intrinsic Value [Roll Forward] Aggregate intrinsic value of grant-date options granted during the reporting period as calculated by applying the disclosed option pricing methodology. Share-based Compensation Arrangement by Share-based Payment Award, Options, Grant in Period, Intrinsic Value Grants Aggregate intrinsic value of forfeitures or expirations option during the reporting period as calculated by applying the disclosed option pricing methodology. Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures or Expirations in Period, Intrinsic Value Forfeitures or expirations A roll forward is a reconciliation of a concept from the beginning of a period to the end of a period. Share-based Compensation Arrangement By Share-based Payment Award Weighted Average Remaining Contractual [Roll Forward] Weighted Average Remaining Contractual Term [Roll Forward] Weighted average remaining contractual term of exercisable stock options, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Sharebased Compensation Shares Exercised Under Stock Option Plans Exercise Price Range Exercisable Options Weighted Average Remaining Contractual Term2 Exercised Weighted average remaining contractual term of outstanding stock options, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Outstanding Options, Expired or Forfeited Weighted Average Remaining Contractual Term Forfeitures or expirations Weighted average remaining contractual term of exercisable stock options, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Share-based Compensation, Shares Granted under Stock Option Plans, Exercise Price Range, Exercisable Options, Weighted Average Remaining Contractual Term Grants Revenue recognized from nonrefundable upfront product license fees. Nonrefundable Upfront Product License Fees [Member] Nonrefundable Upfront Product License Fees [Member] Deferred revenue relating to foreign tax withholding. Milestone Payment Due Foreign Tax Withholding [Member] Milestone Payment Due Foreign Tax Withholding [Member] Accounts Receivables and Allowance For Doubtful Accounts [Abstract] Receivables and Doubtful Accounts [Abstract] Commitments and Contingencies [Abstract] Commitments and Contingencies [Abstract] Refers to the term of notice period for cancellation of lease agreement in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Notice Period To Cancel Lease Agreements Notice period to cancel lease agreements The amount of monthly rent of leased premises during the period. Monthly rent of leased premises Monthly base rent Royalty Buy Down [Abstract] Royalty Buy-Down [Abstract] The cash outflow from initial payment related to the purchase of royalty interests. Payment for royalty buy down Initial payment for royalty buy down Third Party Royalties [Abstract] Third-Party Royalties [Abstract] Number of cash payments made to reduce royalty obligation. Number of cash payments made for royalty obligation Reimbursable Third Party Patent Costs [Abstract] Reimbursable Third-Party Patent Costs [Abstract] Carrying value as of the balance sheet date of obligations incurred through that date and payable for patents. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Accrued patent costs Accrued patent costs The duration period related to the amortization of deferred cost. Deferred Costs Amortization Period Deferred costs, amortization period The number of additional cash payments for royalty buy-down. Number of additional cash payments for royalty buy down Number of additional cash payments for royalty buy-down Disclosure of accounting policy for reimbursable third party patent costs. Reimbursable Third Party Patent Costs [Policy Text Block] Reimbursable Third-Party Patent Costs Disclosure of accounting policy for third party royalties and royalty buy-down. Third Party Royalties and Royalty Buy-Down [Policy Text Block] Third-Party Royalties Disclosure of accounting policy for royalty buy down. Royalty Buy Down [Policy Text Block] Royalty Buy-Down Disclosure of accounting policy for clinical trial expenses. Clinical Trial Expenses [Policy Text Block] Clinical Trial Expenses Sum of the carrying values as of the balance sheet date of obligations incurred through that date and due within one year (or the operating cycle, if longer), including liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received, taxes, interest, rent and utilities, accrued salaries and bonuses, payroll taxes and fringe benefits. Accounts Payable and Accrued Expenses -Third Party Royalties Accounts payable and accrued expenses -third party royalties EX-101.PRE 9 bstc-20180630_pre.xml XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE XML 10 R1.htm IDEA: XBRL DOCUMENT v3.10.0.1
Document and Entity Information - shares
6 Months Ended
Jun. 30, 2018
Aug. 08, 2018
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   7,294,888
Document Fiscal Year Focus 2018  
Document Fiscal Period Focus Q2  
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Jun. 30, 2018  
XML 11 R2.htm IDEA: XBRL DOCUMENT v3.10.0.1
Condensed Consolidated Balance Sheets (unaudited) - USD ($)
Jun. 30, 2018
Dec. 31, 2017
Current assets:    
Cash and cash equivalents [1] $ 12,960,475 $ 7,333,810
Short term investments 53,585,924 [1] 51,973,971
Accounts receivable 12,893,893 [1] 4,655,105
Deferred royalty buy-down 1,124,990 [1] 1,794,126
Prepaid expenses and other current assets 836,979 [1] 623,503
Total current assets 81,402,261 [1] 66,380,515
Long-term investments 7,163,483 [1] 5,745,974
Deferred royalty buy-down - long term, net 0 [1] 732,206
Deferred tax assets, net 321,603 [1] 1,739,706
Patent costs, net 442,968 [1] 397,993
Total assets 89,330,315 [1] 74,996,394
Current liabilities:    
Accounts payable and accrued expenses 1,591,707 [1] 933,998
Income tax payable 801,800 [1] 68,733
Deferred revenue 0 [1] 1,057,979
Accrued liabilities of discontinued operations 0 [1] 78,138
Total current liabilities 2,393,507 [1] 2,138,848
Long-term deferred revenue 0 [1] 5,340,708
Stockholders' equity:    
Series A Preferred stock, $.50 par value, 700,000 shares authorized; none outstanding 0 [1] 0
Common stock, $.001 par value; 10,000,000 shares authorized; 7,655,167 and 7,600,167 shares issued, 7,244,233 and 7,189,233 shares outstanding as of June 30, 2018 and December 31, 2017, respectively 7,655 [1] 7,600
Additional paid-in capital 34,424,632 [1] 33,468,323
Retained earnings 60,402,721 [1] 41,939,115
Treasury stock, 410,934 shares at cost as of June 30, 2018 and December 31, 2017 (7,898,200) [1] (7,898,200)
Total stockholders' equity 86,936,808 [1] 67,516,838
Total liabilities and stockholders' equity $ 89,330,315 [1] $ 74,996,394
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
XML 12 R3.htm IDEA: XBRL DOCUMENT v3.10.0.1
Condensed Consolidated Balance Sheets (unaudited) (Parenthetical) - $ / shares
Jun. 30, 2018
Dec. 31, 2017
Stockholders' equity:    
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, authorized (in shares) 10,000,000 10,000,000
Common stock, issued (in shares) 7,655,167 7,600,167
Common stock, outstanding (in shares) 7,244,233 7,189,233
Treasury stock, shares (in shares) 410,934 410,934
Series A Preferred Stock [Member]    
Stockholders' equity:    
Preferred stock, par value (in dollars per share) $ 0.50 $ 0.50
Preferred stock, authorized (in shares) 700,000 700,000
Preferred stock, outstanding (in shares) 0 0
XML 13 R4.htm IDEA: XBRL DOCUMENT v3.10.0.1
Condensed Consolidated Income Statements (unaudited) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2018
[1]
Jun. 30, 2017
Jun. 30, 2018
[1]
Jun. 30, 2017
Revenue:        
Total Revenues $ 7,096,409 $ 6,535,516 $ 14,185,818 $ 14,226,135
Costs and expenses:        
Research and development 211,796 337,731 407,023 592,512
General and administrative 1,985,212 2,315,283 4,054,845 4,741,000
Total Cost and Expenses 2,197,008 2,653,014 4,461,868 5,333,512
Operating income 4,899,401 3,882,502 9,723,950 8,892,623
Other income:        
Interest income 273,746 140,995 491,697 242,748
Other income 81,985 23,423 96,663 25,985
Total other income 355,731 164,418 588,360 268,733
Income before income tax expense 5,255,132 4,046,920 10,312,310 9,161,356
Provision for income tax expense (954,465) (1,422,829) (2,033,039) (3,192,512)
Net income $ 4,300,667 $ 2,624,091 $ 8,279,271 $ 5,968,844
Basic net income per share (in dollars per share) $ 0.60 $ 0.37 $ 1.15 $ 0.83
Diluted net income per share (in dollars per share) $ 0.59 $ 0.36 $ 1.13 $ 0.81
Shares used in computation of basic net income per share (in shares) 7,215,057 7,170,223 7,204,040 7,167,251
Shares used in computation of diluted net income per share (in shares) 7,315,276 7,329,118 7,309,325 7,330,875
Royalties [Member]        
Revenue:        
Total Revenues $ 7,061,139 $ 6,531,107 $ 14,146,139 $ 14,217,317
Licensing Revenues [Member]        
Revenue:        
Total Revenues $ 35,270 $ 4,409 $ 39,679 $ 8,818
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
XML 14 R5.htm IDEA: XBRL DOCUMENT v3.10.0.1
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($)
6 Months Ended
Jun. 30, 2018
[1]
Jun. 30, 2017
Cash flows from operating activities:    
Net income $ 8,279,271 $ 5,968,844
Adjustments to reconcile net income to net cash provided by operating activities:    
Amortization 1,369,227 1,084,614
Stock-based compensation expense 96,314 66,952
Deferred tax expense 82,341 218,006
Extinguishment of accrued liabilities (78,138) 0
Changes in operating assets and liabilities:    
Accounts receivable (684,061) (852,490)
Income tax receivable (666,874) 204,506
Prepaid expenses and other current assets (213,476) (176,202)
Patent costs (79,485) 0
Accounts payable and accrued expenses 118,696 423,848
Deferred revenue (139,680) (637,459)
Net cash provided by operating activities 8,084,135 6,300,619
Cash flows from investing activities:    
Maturity of marketable investments 37,279,000 32,855,741
Purchases of marketable investments (40,596,520) (37,669,248)
Net cash used in investing activities (3,317,520) (4,813,507)
Cash flows from financing activities:    
Proceeds from stock option exercises 860,050 258,250
Payments for repurchase of common stock 0 (478,762)
Net cash provided by (used in) financing activities 860,050 (220,512)
Increase in cash and cash equivalents 5,626,665 1,266,600
Cash and cash equivalents at beginning of year 7,333,810 4,763,364
Cash and cash equivalents at end of period 12,960,475 6,029,964
Cash paid during the period for:    
Interest 0 0
Taxes $ 2,617,572 $ 2,770,000
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
XML 15 R6.htm IDEA: XBRL DOCUMENT v3.10.0.1
ORGANIZATION AND DESCRIPTION OF BUSINESS
6 Months Ended
Jun. 30, 2018
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 clostridium histolyticum for multiple indications. We currently have a development and license agreement with Endo Global Ventures, a Bermuda unlimited liability company (Endo Global Ventures), an affiliate of Endo International plc (Endo), for injectable collagenase for marketed indications and indications in development. Endo assumed this agreement when Endo acquired Auxilium Pharmaceuticals, Inc. (Auxilium) on January 29, 2015 (the Acquisition). Injectable collagenase clostridium histolyticum is marketed as XIAFLEX® (or Xiapex® in Europe).

On February 1, 2016, we entered into with Endo the First Amendment (the First Amendment) to the Second Amended and Restated Development and Licensing Agreement (the Auxilium Agreement), by and between us and Auxilium, now a wholly-owned subsidiary of Endo, to amend certain provisions of the Auxilium Agreement (as amended by the First Amendment, the License Agreement). The effective date of the First Amendment was January 1, 2016. Pursuant to the First Amendment, we and Endo mutually agreed that in exchange for a $8.25 million lump sum payment, we will not receive future additional mark-up on cost of goods sold for sales by non-affiliated sublicensees of Endo outside of the U.S.; provided, however, that Endo will still be required to pay a mark-up on cost of goods sold for sales made in the Endo Territory, which includes sales made in the U.S. and sales made in any other country where Endo sells the product directly or through affiliated sublicensees.

Additionally, we agreed that Endo may opt-in early to indications, prior to our submission of a clinical trial report, with our consent, such consent not to be unreasonably withheld. For early opt-ins, Endo will be required to make an opt-in payment of $0.5 million on a per indication basis. For regular opt-ins, following our submission of a clinical trial report, Endo will be required to make an opt-in payment of $0.75 million on a per indication basis.

The two marketed indications involving our injectable collagenase are Dupuytrens contracture and Peyronies disease. Prior to the Acquisition, Auxilium had, and after the Acquisition, Endo has, opted-in to the following indications: frozen shoulder, cellulite, canine lipoma, lateral hip fat, plantar fibromatosis and human lipoma. Endo exercised, with our consent, an early opt-in for lateral hip fat and plantar fibromatosis in November 2015. Endo opted-in for human lipoma in July 2016. We manage the development of XIAFLEX for uterine fibroids and initiate the development of XIAFLEX in new potential indications, not licensed by Endo.

On November 8, 2016, following a change in Endo management, Endo announced that a commercial review is ongoing of the XIAFLEX exercised but non-marketed indications, including frozen shoulder, cellulite, lateral hip fat, plantar fibromatosis and human lipoma, so that Endo can best prioritize its R&D efforts and determine clinical trial timelines moving forward. On February 6, 2018, Endo initiated two identical Phase 3 RELEASE clinical trials of XIAFLEX for the treatment of cellulite. The multicenter, randomized, double-blind, placebo-controlled RELEASE studies will evaluate the safety and efficacy of XIAFLEX in reducing the appearance of cellulite.

Endo is currently selling XIAFLEX in the U.S. for the treatment of Dupuytrens contracture and Peyronies disease and has an agreement with Swedish Orphan Biovitrum AB (Sobi), pursuant to which Sobi has marketing rights for Xiapex for Dupuytrens contracture and Peyronies disease in Europe and certain Eurasian countries. Sobi is currently selling Xiapex in Europe and certain Eurasian countries for the treatment of Dupuytrens contracture and Peyronies disease. In addition, Endo has an agreement with Asahi Kasei Pharma Corporation (Asahi) pursuant to which Asahi has the right to commercialize XIAFLEX for the treatment of Dupuytrens contracture and Peyronies disease in Japan. Asahi is selling XIAFLEX for the treatment of Dupuytrens contracture in Japan. Endo is currently distributing XIAFLEX in Canada through Paladin Labs Inc., an operating company of Endo. In December 2016, Endo entered into a new out-licensing agreement with Actelion Pharmaceuticals Ltd. (“Actelion”), pursuant to which Actelion obtained marketing and commercial rights for XIAFLEX in Australia and New Zealand.
XML 16 R7.htm IDEA: XBRL DOCUMENT v3.10.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
6 Months Ended
Jun. 30, 2018
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Except as detailed below, there have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2018, as compared to the significant accounting policies disclosed in Note 2 of the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.
 
Basis of Presentation

The accompanying condensed 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 the risk factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on March 14, 2018 and in Item 1A of Part 2 of our Quarterly Report on Form 10-Q for the quarter end March 31, 2018 filed with the SEC on May 10, 2018.
 
Principles of Consolidation

The condensed consolidated financial statements include the accounts of the Company and its subsidiary, Advance Biofactures Corp. All intercompany balances and transactions have been eliminated.

Critical Accounting Policies, Estimates and Assumptions

The preparation of condensed 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 condensed consolidated financial statements and accompanying notes. The Company makes certain assumptions and estimates for its revenues, deferred tax assets, third party royalties and deferred royalty buy-down. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and the amount of revenues and expenses. Actual results may differ from these estimates under different assumptions or conditions. For further details, see notes “Revenue Recognition”, “Provision for Income Taxes” and “Third-Party Royalties and Royalty Buy-Down.” Actual results may differ from those estimates.
 
Revenue Recognition

Beginning in 2014, Financial Accounting Standards Board (“FASB”) issued several Accounting Standards Updates establishing ASC Topic 606, “Revenue from Contracts with Customers” (“ASC 606”).  ASC 606 requires retrospective implementation, and replaces most industry-specific revenue recognition guidance in U.S. GAAP with a new principles-based, five-step revenue recognition model.  The Company adopted ASC 606 effective January 1, 2018. Under ASC 606, we recognize revenues when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. We recognize revenues following the five step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligation(s).

Revenues, and their respective treatment for financial reporting purposes under ASC 606 and our license agreement with Endo, are as follows:

Royalty / Mark-Up on Cost of Goods Sold
 
We receive royalty revenues on net sales and mark-up on cost of goods sold revenue in the U.S. under our License Agreement with Endo. These are presented in “Royalties” in our condensed consolidated statements of income.  We do not have future performance obligations under this revenue stream. In accordance with ASC 606, we record these revenues based on estimates of the net sales that occurred during the relevant period. The relevant period estimates of these royalties are based on interim data provided by Endo (when available) and analysis of historical royalties and mark-up on cost of goods sold revenue that have been paid to us, adjusted for any changes in facts and circumstances, as appropriate. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known, typically the following quarter. The royalties payable by Endo to us are subject to set-off for certain patent costs.
 
Licensing Revenue

We include revenue recognized from upfront licensing, sublicensing and milestone payments in “License Revenues” in our condensed consolidated statements of income.

The Company recognizes licensing revenues generated through development and/or commercialization agreements. The terms of these agreements typically include payment to the Company of one or more of the following: nonrefundable, upfront license fees; sublicensing; development and commercial milestone payments; development activities; and royalties on net sales of licensed products. Each of these types of payments results in licensing revenues except for revenues from royalties on net sales of licensed products and the mark-up of cost of goods sold revenues which are classified as royalty revenues. Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the customer.

For each development and/or commercialization agreement that result in revenues, the Company identifies all performance obligations, aside from those that are immaterial which may include a license to intellectual property and know-how, development activities and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.

If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, upfront license fees based on the relative standalone selling price prescribed to the license compared to the total value of the arrangement. The revenue is recognized when the license is transferred to the collaborator and the collaborator is able to use and benefit from the license.  For licenses that are not distinct from other obligations identified in the arrangement, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, the Company applies an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees.  The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

Development and Regulatory Milestone Payments

Depending on facts and circumstances, the Company may conclude that it is appropriate to include the milestone, representing variable consideration, in the estimated total transaction price, or that it is appropriate to fully constrain the milestone. The Company may include revenues from certain milestones in the total transaction price in a reporting period before the milestone is achieved if the Company concludes that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods. The Company records a corresponding contract asset when this conclusion is reached. Milestone payments that have not been included in the transaction price to date are fully constrained. The Company re-evaluates the probability of achievement of such development milestones and any related constraint each reporting period. The Company adjusts its estimate of the total transaction price, including the amount of revenue that it has recorded, if necessary.
 
RECENT ACCOUNTING PRONOUNCEMENTS

Accounting Pronouncements Adopted
 
Effective January 1, 2018, the Company adopted ASC 606, which provides principles for recognizing revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company adopted ASC 606 on a modified retrospective basis through a cumulative adjustment to equity. See Note 2 – Significant Accounting PoliciesRevenue Recognition.

The adoption of ASC 606 as of January 1, 2018, applying the modified-retrospective method, changed the timing of our recognition of royalty and mark-up cost of goods sold revenue. Beginning in 2018, we recorded these royalty revenues based on estimates of the net sales and mark-up cost of goods sold that occurred during the relevant period thereby eliminating the one quarter lag. Previously, these amounts were not recognized until they were fixed and determinable. In addition, deferred revenue associated with the prepayment of foreign mark-up on cost of goods sold revenue will no longer be recognized over time based on sales by non-affiliated sublicensees of Endo outside of the U.S. and, under ASC 606, would have been recognized when the transaction occurred in 2016.

The cumulative effect of applying the new guidance of ASC 606 to our License Agreement with Endo as of January 1, 2018 was recorded as an adjustment to retained earnings as of the adoption date. As a result of applying the modified retrospective method to adopt the new revenue guidance, the following adjustments were made to accounts on the Condensed Consolidated Balance Sheet as of January 1, 2018:

The Company recorded the following cumulative effect as of January 1, 2018, itemized here (in millions):
 
  
As reported
December 31, 2017
  
Adjustments
  
Adjusted
January 1, 2018
 
Accounts receivable
 
$
4.7
  
$
7.6
(1) 
 
$
12.3
 
Deferred revenue
  
(6.4
)
  
6.3
(2) 
  
(0.1
)
Deferred royalty buy-down
  
(2.5
)
  
(0.4
)(3)
  
(2.9
)
Accounts payable and accrued expenses -third party royalties
  
(0.4
)
  
(0.5
)(3)
  
(0.9
)
Deferred tax assets, net
  
1.7
   
(1.3
)(4)
  
0.4
 
Income tax payable
  
-
   
(1.4
)(5)
  
(1.4
)
             
Retained earnings adjustment
 
$
(2.9
)
 
$
10.3
  
$
7.4
 
 
(1)
This adjustment represents the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017.
(2)
Represents the remaining deferred revenue balance of the prepaid mark-up on cost of goods sold based on sales by non-affiliated sublicensees of Endo outside of the U.S.
(3)
Represents the amortization of the royalty buy-down and third party royalties expense associated royalty revenues based on XIALFLEX net sales reported to us by Endo for the fourth quarter of 2017.
(4)
To reverse a deferred tax asset associated with the deferred revenue balance of the prepaid mark-up on cost of goods sold by non-affiliated sublicensees of Endo outside of the U.S.
(5)
To create a tax liability associated the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017.

At June 30, 2018, contract assets of $7.1 million for which there’s an unconditional right to receive payment was included in accounts receivable on the condensed consolidated balance sheet.
 
In accordance with the new revenue standard requirements, the impact of adoption on our condensed consolidated balance sheet was as follows (in millions):

  
June 30, 2018
 
  
As Reported
  
Balances Without
Adoption of New
Revenue Standard
  
Effect of Change
Higher / (Lower)
 
Assets
         
Accounts receivable
 
$
12.9
  
$
5.8
  
$
7.1
 
Deferred royalty buy-down
  
1.1
   
1.3
   
(0.2
)
Deferred tax assets
  
0.3
   
1.5
   
(1.2
)
Liabilities
            
Accounts payable and accrued expenses
  
1.6
   
1.1
   
0.5
 
Deferred revenue
  
-
   
0.9
   
(0.9
)
Income tax payable
  
0.8
   
0.5
   
(1.3
)
Deferred revenue, long term
  
-
   
4.9
   
(4.9
)
Equity
            
Retained earnings
  
60.4
   
50.7
   
9.7
 
 
In accordance with the new revenue standard requirements, the impact of adoption on our condensed consolidated statement of operations for the three and six months ended June 30, 2018 was as follows (in millions):

  
Three Months Ended June 30, 2018
 
  
As Reported
  
Balances Without
Adoption of New
Revenue Standard
  
Effect of Change
Higher / (Lower)
 
Revenues
         
Royalties
 
$
7.1
  
$
7.3
  
$
(0.2
)
Costs and expenses
            
General and administrative
 
$
2.0
  
$
2.0
  
$
-
 
Provision for income taxes
  
1.0
   
1.0
   
-
 
Net income
  
4.3
   
4.5
   
(0.2
)

  
Six Months Ended June 30, 2018
 
  
As Reported
  
Balances Without
Adoption of New
Revenue Standard
  
Effect of Change
Higher / (Lower)
 
Revenues
         
Royalties
 
$
14.2
  
$
15.0
  
$
(0.8
)
Costs and expenses
            
General and administrative
 
$
4.1
  
$
4.1
  
$
-
 
Provision for income taxes
  
2.0
   
2.2
   
(0.2
)
Net income
  
8.3
   
8.9
   
(0.6
)

In January 2016, the FASB issued new guidance on recognition and measurement of financial assets and financial liabilities. The new guidance will impact the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. All equity investments in unconsolidated entities (other than those accounted for under the equity method of accounting) will generally be measured at fair value with changes in fair value recognized through earnings. There will no longer be an available-for-sale classification (changes in fair value reported in other comprehensive income (loss) for equity securities with readily determinable fair values). In addition, the FASB clarified the need for a valuation allowance on deferred tax assets resulting from unrealized losses on available-for-sale debt securities. In general, the new guidance will require modified retrospective application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings. The adoption of the new standard as of January 1, 2018 had no impact on our consolidated financial statements and related disclosure as we do not currently have any available-for-sale equity investments.
 
Accounting Pronouncements Not Yet Adopted

In February 2016, FASB issued Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). Under the new guidance, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the lease commencement date: a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. Under the new guidance, lessor accounting is largely unchanged. Certain targeted improvements were made to align, where necessary, lessor accounting with the lessee accounting model and Topic 606, Revenue from Contracts with Customers. The new lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. Lessees will no longer be provided with a source of off-balance sheet financing. Public business entities should apply the amendments in ASU 2016-02 for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years (i.e., January 1, 2019, for a calendar year entity). Early application is permitted.  Lessees (for capital and operating leases) and lessors (for sales-type, direct financing, and operating leases) must apply a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. Lessees and lessors may not apply a full retrospective transition approach. We are currently evaluating the impact that the standard could have on our consolidated financial statements and related disclosures.

In June 2016, FASB issued ASU 2016-13, Financial Instruments - Credit Losses. The amendment revises the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in more timely recognition of losses on financial instruments, including, but not limited to, available for sale debt securities and accounts receivable. The Company is required to adopt this standard starting in the first quarter of fiscal year 2021. Early adoption is permitted. We are currently evaluating the impact of the adoption of this standard on our consolidated financial statements and related disclosures.

Cash, Cash Equivalents and Investments

Cash equivalents include only securities having a maturity of 90 days or less at the time of purchase.  Investments are stated on an amortized cost basis. The Company limits its credit risk associated with cash, cash equivalents and investments by placing its investments with banks it believes are highly creditworthy and with highly rated money market funds, certificates of deposit, municipal bonds and corporate bonds. All investments are classified as held to maturity. As of June 30, 2018 and December 31, 2017, the amortized cost of these investments was $60.7 million and $57.7 million, respectively. No unrealized gains or losses were recorded in either period.

Fair Value Measurements

Management believes that the carrying amounts of the Company’s financial instruments, including cash, cash equivalents, held to maturity investments, accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of those instruments. As of June 30, 2018 and December 31, 2017, there were no recorded unrealized gains or losses on our investments as they are classified as held to maturity. As of June 30, 2018 and December 31, 2017, amortized cost basis of the investments approximated their fair value. At June 30, 2018 and December 31, 2017, the amortized premium included in interest income was $288,000 and $673,000, respectively.

The following table presents the Company’s schedule of maturities at June 30, 2018 and December 31, 2017:
 
  
Maturities as of
June 30, 2018
  
Maturities as of
December 31, 2017
 
  
1 Year or
Less
  
Greater than 1
Year
  
1 Year or
Less
  
Greater than
1 Year
 
Municipal bonds
 
$
4,870,100
  
$
-
  
$
1,002,650
  
$
100,000
 
Corporate bonds
  
45,120,776
   
5,417,988
   
48,143,495
   
3,155,573
 
Certificates of deposit
  
3,595,048
   
1,745,495
   
2,827,826
   
2,490,401
 
Total
 
$
53,585,924
  
$
7,163,483
  
$
51,973,971
  
$
5,745,974
 
 
The authoritative literature for fair value measurements established a three-tier fair value hierarchy, which prioritizes the inputs in measuring fair value. These tiers are as follows: Level 1, defined as observable inputs such as quoted market prices in active markets; Level 2, defined as inputs other than the quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as significant unobservable inputs (entity developed assumptions) in which little or no market data exists.
 
As of June 30, 2018, the Company held certain investments that are required to be measured at fair value on a recurring basis. The following tables present the Company’s fair value hierarchy for these financial assets as of June 30, 2018 and December 31, 2017:
 
June 30, 2018
 
Type of Instrument
 
Fair Value
  
Level 1
  
Level 2
  
Level 3
 
               
Cash equivalents
 
Institutional Money Market
 
$
4,928,319
  
$
4,928,319
  
$
-
  
$
-
 
                   
Cash equivalents
 
Municipal Bonds
  
2,520,000
   
2,520,000
   
-
   
-
 
                   
Cash equivalents
 
Corporate Bonds
  
1,862,000
   
1,862,000
   
-
   
-
 
                   
Investments
 
Municipal Bonds
  
4,870,100
   
-
   
4,870,100
   
-
 
                   
Investments
 
Corporate Bonds
  
50,538,764
   
-
   
50,538,764
   
-
 
                   
Investments
 
Certificates of Deposit
  
5,340,543
   
5,340,543
   
-
   
-
 

December 31, 2017
 
Type of Instrument
 
Fair Value
  
Level 1
  
Level 2
  
Level 3
 
               
Cash equivalents
 
Institutional Money Market
 
$
3,108,549
  
$
3,108,549
  
$
-
  
$
-
 
                   
Cash equivalents
 
Municipal Bonds
  
800,000
   
-
   
800,000
   
-
 
                   
Investments
 
Municipal Bonds
  
1,102,650
   
-
   
1,102,650
   
-
 
                   
Investments
 
Corporate Bonds
  
51,299,068
   
-
   
51,299,068
   
-
 
                   
Investments
 
Certificates of Deposit
  
5,318,227
   
5,318,227
   
-
   
-
 

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 investments in FDIC insured certificates of deposits, municipal bonds and corporate bonds.

The Company is currently dependent on one customer, Endo, who generates almost all its revenues. For the three and six months ended June 30, 2018, licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately $7.1 million and $14.2 million, respectively, and for the three and six months ended June 30, 2017, the licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately $6.5 million and $14.2 million, respectively.

At June 30, 2018 and December 31, 2017, our accounts receivable balances from Endo were $12.9 million and $4.7 million, respectively.

Treasury Stock
 
The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders’ equity. For the six months ended June 30, 2018, there were no shares repurchased as compared to the repurchase of 9,283 shares at an average price of $51.57 in the corresponding 2017 period.
 
Receivables and Doubtful Accounts
 
Trade accounts receivable are stated at the amount the Company expects to collect. We may maintain allowances for doubtful accounts for estimated losses resulting from the inability of our 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 Endo, our one large specialty pharmaceutical customer.  Endo has historically paid timely and has been a financially stable organization.  Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.  If the financial condition of our customer were to deteriorate, adversely affecting its ability to make payments, additional allowances would be required.  We may 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, 2018 and December 31, 2017 our accounts receivable balance was $12.9 million and $4.7 million, respectively, and was from one customer, Endo. With the adoption of ASC 606 as of January 1, 2018, using the modified-retrospective adoption method, we recorded an adjustment to our accounts receivable balance of $7.6 million related to royalties associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)

Deferred Revenue

With the adoption of ASC 606 using the modified retrospective adoption method as of January 1, 2018, the remaining deferred revenue balance associated with the mark-up on cost of goods sold for sales by non-affiliated sublicensees of Endo outside of the U.S. as of December 31, 2017 of $6.3 million was recorded as an adjustment to our retained earnings. Additionally, approximately $35,000 related to nonrefundable upfront product license fees for product candidates for which we have no remaining performance obligations was recognized during the second quarter of 2018. Finally, during the second quarter of 2018 we determined that the $100,000 related to a milestone payment withheld by Endo due to a foreign tax withholding was uncollectable and have reduced this amount to zero. As of June 30, 2018 and December 31, 2017, deferred revenue was zero and $6.4 million, respectively. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)

Reimbursable Third-Party Patent Costs

We accrue patent costs that are reimbursable to Endo by us under the License Agreement. We capitalize certain patent costs related to patent prosecution and maintenance and expense others. As of June 30, 2018 and December 31, 2017, our net reimbursable third party patent expense was $49,000 and zero, respectively.

Third-Party Royalties

We have entered into licensing and royalty agreements with third parties and agreed to pay certain royalties on net sales of products for specific indications. The royalty rates differ from agreement to agreement and, in certain cases, have been redacted with the permission of the SEC.  No assumptions should be made that any disclosed royalty rate payable to a particular third party is the same or similar with respect to any royalty rate payable to any other third parties. We accrue third-party royalty expenses on net sales reported to us by Endo. Third-party royalty costs are generally expensed under general and administrative in the quarter that the net sales have occurred. For the three and six month periods ended June 30, 2018, third-party royalty expenses were $0.5 million and $1.0 million, respectively. For the three and six month periods ended June 30, 2017, third-party royalty expenses were $0.4 million and $0.9 million, respectively. With the adoption of ASC 606 as of January 1, 2018 using the modified-retrospective adoption method, we recorded an adjustment to our retained earnings for third party royalties expense of $0.5 million associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag. Our third-party royalty expense under general and administrative expenses may increase if net sales by Endo and its partners for XIAFLEX and Xiapex increase and potential new indications for XIAFLEX and Xiapex are approved, marketed and sold. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)
 
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 in connection with 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 of $600,000, all of which have been paid as of June 30, 2018.  Royalty obligations terminate five years after first commercial sale which occurred in January 2014. The Company amortizes long-term contracts with finite lives in a manner that reflects the pattern in which the economic benefits of the assets are consumed or otherwise used up. Dr. Gelbard’s agreement is amortized based on an income forecast method by estimating sales of XIAFLEX and Xiapex for Peyronie’s disease on an annual basis as measured by the proportion of the total estimated sales over the five year period. For the three and six months ended June 30, 2018 and 2017, we amortized approximately $0.5 million and $1.0 million related to this agreement, respectively and $0.4 million and $0.7 million for the three and six months ended June 30, 2017. With the adoption of ASC 606 as of January 1, 2018 using the modified-retrospective adoption method, we recorded an adjustment to our capitalized balance of $0.4 million related to royalties associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag. As of June 30, 2018 and December 31, 2017, the remaining capitalized balances were approximately $1.1 million and $2.5 million, respectively. We perform an evaluation of the recoverability of the carrying value to determine if facts and circumstances indicate that the carrying value of the assets may be impaired and if any adjustment is warranted.  As of June 30, 2018, there was no indicator that an impairment existed. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)

Research and Development Expenses

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 consultants. 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 one stock-based compensation plan 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 stock options including stock options and common stock issued to our employees and directors under our stock plans. ASC 718 requires companies to estimate the fair value of stock option 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 condensed consolidated statements of operations.
 
Under ASC 718, we estimate the fair value of our employee stock option 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 option award, we consider the vesting period for the award, our recent historical experience of employee stock option exercises (including forfeitures) and the expected volatility of our common stock.  As required under the accounting rules, we review our estimates at each grant date and, as a result, the valuation assumptions that we use to value employee stock-based awards granted in future periods may change. For the six months ended June 30, 2018, we granted a total of 31,500 stock options with a weighted average grant date fair value of $18.00 per share.
 
The assumptions used in the valuation of stock options granted during the six months ended June 30, 2018 were as follows:

 
Six Months Ended
June 30, 2018
 
Risk-free interest rate
 
2.62% to 2.81
%
Expected term of option
 
6.25 years
 
Expected stock price volatility
 
39.6% to 39.7
%
Expected dividend yield
 
$
0.0
 
 
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 in general and administrative expenses was approximately $63,000 and $96,000 for the three and six month periods ended June 30, 2018 and approximately $33,000 and $67,000 for the three and six months ended June 30, 2017, respectively.

Stock Option Activity

A summary of our stock option activity during the six months ended June 30, 2018 is presented below:
 
  
Shares
  
Weighted
Average
Exercise
Price
  
Weighted
Average
Remaining
Contractual
Term
  
Aggregate
Intrinsic
Value
 
Outstanding at December 31, 2017
  
232,000
  
$
21.56
   
2.52
  
$
5,050,990
 
Grants
  
31,500
   
41.79
   
-
   
-
 
Exercised
  
(55,000
)
  
15.64
   
-
   
1,454,650
 
Forfeitures or expirations
  
-
   
-
   
-
   
-
 
Outstanding at June 30, 2018
  
208,500
  
$
26.18
   
3.37
  
$
3,895,465
 
Exercisable at June 30, 2018
  
169,500
  
$
22.77
   
2.04
  
$
3,744,550
 

During the six months ended June 30, 2018 and 2017, the Company received approximately $860,000 and $258,000, respectively, from stock options exercised by option holders.

Aggregate intrinsic value represents the total pre-tax intrinsic value based on the closing price of our common stock of $44.86 on June 29, 2018, which would have been received by the option holders had all option holders exercised their options as of that date. We have approximately $611,000 in unrecognized compensation cost related to stock options outstanding as of June 30, 2018, which we expect to recognize over the next 3.31 years.
 
Property and Equipment

Property and equipment are stated at cost, less accumulated depreciation. Machinery and equipment, furniture and fixtures, and autos are depreciated on a straight-line basis over their estimated useful lives of five to ten years. Leasehold improvements are amortized over the lesser of their estimated useful lives or the remaining life of the lease. At each of June 30, 2018 and December 31, 2017, property and equipment were fully depreciated.

Comprehensive Income

For each of the three and six month periods ended June 30, 2018 and 2017, we had no components of other comprehensive income other than net income itself.

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.

The Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon the ultimate settlement. As of June 30, 2018 and December 31, 2017, the Company has not recorded any unrecognized tax benefits.

Commitments and Contingencies

On November 6, 2017, the Company entered into an agreement with the Landlord to extend the term of the lease to the Headquarters for an additional one year period (the “Extended Lease Agreement”). The one year extension will end on November 30, 2018. Pursuant to the Extended Lease Agreement, the base rent is $11,165 per month and the Company may cancel the lease with three months’ prior written notice to the Landlord at any time during the term.
XML 17 R8.htm IDEA: XBRL DOCUMENT v3.10.0.1
NET INCOME PER SHARE
6 Months Ended
Jun. 30, 2018
NET INCOME PER SHARE [Abstract]  
NET INCOME PER SHARE
3. NET INCOME PER SHARE

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

The following table summarizes the number of common equivalent shares that were excluded for the calculation of diluted net income per share reported in the condensed consolidated statement of operations.

  
Three Months Ended
June 30,
  
Six Months Ended
June 30,
 
  
2018
  
2017
  
2018
  
2017
 
Stock options
  
-
   
20,000
   
-
   
20,000
 

For the three and six months ended June 30, 2017, the Company had 20,000 options, which have an exercise price of $29.21, and would have vested upon the achievement of certain performance criteria, which were not met.  These options would have expired on December 2, 2019.  On October 25, 2017, these 20,000 options were cancelled due to a change in status of a certain consultant.
XML 18 R9.htm IDEA: XBRL DOCUMENT v3.10.0.1
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
6 Months Ended
Jun. 30, 2018
ACCOUNTS PAYABLE AND ACCRUED EXPENSES [Abstract]  
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
4. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consisted of the following:

  
June 30,
2018
  
December 31,
2017
 
Trade accounts payable
 
$
34,553
  
$
152,542
 
Accrued legal and other professional fees
  
219,223
   
150,691
 
Accrued payroll and related costs
  
182,746
   
215,322
 
Third party royalties
  
1,018,308
   
329,211
 
Other accruals
  
136,877
   
86,232
 
Total
 
$
1,591,707
  
$
933,998
 
XML 19 R10.htm IDEA: XBRL DOCUMENT v3.10.0.1
PATENT COSTS
6 Months Ended
Jun. 30, 2018
PATENT COSTS [Abstract]  
PATENT COSTS
5. PATENT COSTS

We amortize intangible assets with definite lives on a straight-line basis over their remaining estimated useful lives, ranging from two to ten 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.  We analyze our intangible assets, specifically, capitalized patent costs, on an annual basis for any indicator that an impairment exists.

For the six months ended June 30, 2018, we increased our capitalized patent costs based on reports provided to us by Endo. Patent costs may be creditable against future royalty revenues. For each period presented below, net patent costs consisted of:

  
June 30,
2018
  
December 31,
2017
 
Patents
  
1,004,502
  
$
925,016
 
Accumulated amortization
  
(561,534
)
  
(527,023
)
  
$
442,968
  
$
397,993
 

The amortization expense for patents for the three and six months ended June 30, 2018 was approximately $18,000 and $35,000, respectively and for the three and six months ended June 30, 2017 was approximately $10,000 and $20,000, respectively. The estimated aggregate amortization expense for the remaining six months of 2018 and each of the years below is approximately as follows:
 
July 1, 2018 - December 31, 2018
 
$
36,000
 
2019
  
69,700
 
2020
  
53,700
 
2021
  
37,800
 
2022
  
37,800
 
Thereafter
  
208,000
 
XML 20 R11.htm IDEA: XBRL DOCUMENT v3.10.0.1
PROVISION FOR INCOME TAXES
6 Months Ended
Jun. 30, 2018
PROVISION FOR INCOME TAXES [Abstract]  
PROVISION FOR INCOME TAXES
6. PROVISION FOR INCOME TAXES

Our deferred tax liabilities and deferred tax assets are impacted by events and transactions arising in the ordinary course of business, R&D activities, vesting of nonqualified options and other items. The provision for income taxes is based on an estimated effective tax rate derived from our consolidated earnings before taxes, adjusted for nondeductible expenses and other permanent differences for the fiscal year. For the three and six months ended June 30, 2018, the provision for income taxes was $1.0 million and $2.0 million, respectively. As of June 30, 2018 and December 31, 2017, our remaining deferred tax assets were approximately $0.3 million and $1.7 million, respectively.

For the three and six months ended June 30, 2017, the provision for income taxes was $1.4 million and $3.2 million, respectively.
 
The estimated effective tax rate for the three and six months ended June 30, 2018 was 18.2% and 19.7%, respectively, of pre-tax income reported in the period, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2018 plus the effects of certain discrete items occurring in 2018. Our effective tax rate for the six months ended June 30, 2018 was impacted primarily by the Tax Cuts and Jobs Act of 2017, which was enacted on December 22, 2017 and lowered the U.S. corporate tax rate from 35% to 21%, beginning in 2018. Our effective tax rate was also impacted by the discrete impact of current period stock option exercises which impacts the effective rate in the period in which it occurs. The effective tax rate for the six months ended June 30, 2017 was 34.8% of pre-tax income reported in the period, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2017 plus the effects of certain material discrete items that occurred in 2017.
As of June 30, 2018, the Company has no unrecognized tax benefits or related interest and penalties. Management does not believe that there is any tax position which it is reasonably possible that will result in unrecognized tax benefit within the next 12 months.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
6 Months Ended
Jun. 30, 2018
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
Basis of Presentation
Basis of Presentation

The accompanying condensed 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 the risk factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the SEC on March 14, 2018 and in Item 1A of Part 2 of our Quarterly Report on Form 10-Q for the quarter end March 31, 2018 filed with the SEC on May 10, 2018.
Principles of Consolidation
Principles of Consolidation

The condensed consolidated financial statements include the accounts of the Company and its subsidiary, Advance Biofactures Corp. All intercompany balances and transactions have been eliminated.
Critical Accounting Policies, Estimates and Assumptions
Critical Accounting Policies, Estimates and Assumptions

The preparation of condensed 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 condensed consolidated financial statements and accompanying notes. The Company makes certain assumptions and estimates for its revenues, deferred tax assets, third party royalties and deferred royalty buy-down. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and the amount of revenues and expenses. Actual results may differ from these estimates under different assumptions or conditions. For further details, see notes “Revenue Recognition”, “Provision for Income Taxes” and “Third-Party Royalties and Royalty Buy-Down.” Actual results may differ from those estimates.
Revenue Recognition
Revenue Recognition

Beginning in 2014, Financial Accounting Standards Board (“FASB”) issued several Accounting Standards Updates establishing ASC Topic 606, “Revenue from Contracts with Customers” (“ASC 606”).  ASC 606 requires retrospective implementation, and replaces most industry-specific revenue recognition guidance in U.S. GAAP with a new principles-based, five-step revenue recognition model.  The Company adopted ASC 606 effective January 1, 2018. Under ASC 606, we recognize revenues when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. We recognize revenues following the five step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligation(s).

Revenues, and their respective treatment for financial reporting purposes under ASC 606 and our license agreement with Endo, are as follows:

Royalty / Mark-Up on Cost of Goods Sold
 
We receive royalty revenues on net sales and mark-up on cost of goods sold revenue in the U.S. under our License Agreement with Endo. These are presented in “Royalties” in our condensed consolidated statements of income.  We do not have future performance obligations under this revenue stream. In accordance with ASC 606, we record these revenues based on estimates of the net sales that occurred during the relevant period. The relevant period estimates of these royalties are based on interim data provided by Endo (when available) and analysis of historical royalties and mark-up on cost of goods sold revenue that have been paid to us, adjusted for any changes in facts and circumstances, as appropriate. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known, typically the following quarter. The royalties payable by Endo to us are subject to set-off for certain patent costs.
 
Licensing Revenue

We include revenue recognized from upfront licensing, sublicensing and milestone payments in “License Revenues” in our condensed consolidated statements of income.

The Company recognizes licensing revenues generated through development and/or commercialization agreements. The terms of these agreements typically include payment to the Company of one or more of the following: nonrefundable, upfront license fees; sublicensing; development and commercial milestone payments; development activities; and royalties on net sales of licensed products. Each of these types of payments results in licensing revenues except for revenues from royalties on net sales of licensed products and the mark-up of cost of goods sold revenues which are classified as royalty revenues. Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the customer.

For each development and/or commercialization agreement that result in revenues, the Company identifies all performance obligations, aside from those that are immaterial which may include a license to intellectual property and know-how, development activities and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.

If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, upfront license fees based on the relative standalone selling price prescribed to the license compared to the total value of the arrangement. The revenue is recognized when the license is transferred to the collaborator and the collaborator is able to use and benefit from the license.  For licenses that are not distinct from other obligations identified in the arrangement, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, the Company applies an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees.  The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

Development and Regulatory Milestone Payments

Depending on facts and circumstances, the Company may conclude that it is appropriate to include the milestone, representing variable consideration, in the estimated total transaction price, or that it is appropriate to fully constrain the milestone. The Company may include revenues from certain milestones in the total transaction price in a reporting period before the milestone is achieved if the Company concludes that achievement of the milestone is probable and that recognition of revenue related to the milestone will not result in a significant reversal in amounts recognized in future periods. The Company records a corresponding contract asset when this conclusion is reached. Milestone payments that have not been included in the transaction price to date are fully constrained. The Company re-evaluates the probability of achievement of such development milestones and any related constraint each reporting period. The Company adjusts its estimate of the total transaction price, including the amount of revenue that it has recorded, if necessary.
Recent Accounting Pronouncements
RECENT ACCOUNTING PRONOUNCEMENTS

Accounting Pronouncements Adopted
 
Effective January 1, 2018, the Company adopted ASC 606, which provides principles for recognizing revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The Company adopted ASC 606 on a modified retrospective basis through a cumulative adjustment to equity. See Note 2 – Significant Accounting PoliciesRevenue Recognition.

The adoption of ASC 606 as of January 1, 2018, applying the modified-retrospective method, changed the timing of our recognition of royalty and mark-up cost of goods sold revenue. Beginning in 2018, we recorded these royalty revenues based on estimates of the net sales and mark-up cost of goods sold that occurred during the relevant period thereby eliminating the one quarter lag. Previously, these amounts were not recognized until they were fixed and determinable. In addition, deferred revenue associated with the prepayment of foreign mark-up on cost of goods sold revenue will no longer be recognized over time based on sales by non-affiliated sublicensees of Endo outside of the U.S. and, under ASC 606, would have been recognized when the transaction occurred in 2016.

The cumulative effect of applying the new guidance of ASC 606 to our License Agreement with Endo as of January 1, 2018 was recorded as an adjustment to retained earnings as of the adoption date. As a result of applying the modified retrospective method to adopt the new revenue guidance, the following adjustments were made to accounts on the Condensed Consolidated Balance Sheet as of January 1, 2018:

The Company recorded the following cumulative effect as of January 1, 2018, itemized here (in millions):
 
  
As reported
December 31, 2017
  
Adjustments
  
Adjusted
January 1, 2018
 
Accounts receivable
 
$
4.7
  
$
7.6
(1) 
 
$
12.3
 
Deferred revenue
  
(6.4
)
  
6.3
(2) 
  
(0.1
)
Deferred royalty buy-down
  
(2.5
)
  
(0.4
)(3)
  
(2.9
)
Accounts payable and accrued expenses -third party royalties
  
(0.4
)
  
(0.5
)(3)
  
(0.9
)
Deferred tax assets, net
  
1.7
   
(1.3
)(4)
  
0.4
 
Income tax payable
  
-
   
(1.4
)(5)
  
(1.4
)
             
Retained earnings adjustment
 
$
(2.9
)
 
$
10.3
  
$
7.4
 
 
(1)
This adjustment represents the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017.
(2)
Represents the remaining deferred revenue balance of the prepaid mark-up on cost of goods sold based on sales by non-affiliated sublicensees of Endo outside of the U.S.
(3)
Represents the amortization of the royalty buy-down and third party royalties expense associated royalty revenues based on XIALFLEX net sales reported to us by Endo for the fourth quarter of 2017.
(4)
To reverse a deferred tax asset associated with the deferred revenue balance of the prepaid mark-up on cost of goods sold by non-affiliated sublicensees of Endo outside of the U.S.
(5)
To create a tax liability associated the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017.

At June 30, 2018, contract assets of $7.1 million for which there’s an unconditional right to receive payment was included in accounts receivable on the condensed consolidated balance sheet.
 
In accordance with the new revenue standard requirements, the impact of adoption on our condensed consolidated balance sheet was as follows (in millions):

  
June 30, 2018
 
  
As Reported
  
Balances Without
Adoption of New
Revenue Standard
  
Effect of Change
Higher / (Lower)
 
Assets
         
Accounts receivable
 
$
12.9
  
$
5.8
  
$
7.1
 
Deferred royalty buy-down
  
1.1
   
1.3
   
(0.2
)
Deferred tax assets
  
0.3
   
1.5
   
(1.2
)
Liabilities
            
Accounts payable and accrued expenses
  
1.6
   
1.1
   
0.5
 
Deferred revenue
  
-
   
0.9
   
(0.9
)
Income tax payable
  
0.8
   
0.5
   
(1.3
)
Deferred revenue, long term
  
-
   
4.9
   
(4.9
)
Equity
            
Retained earnings
  
60.4
   
50.7
   
9.7
 
 
In accordance with the new revenue standard requirements, the impact of adoption on our condensed consolidated statement of operations for the three and six months ended June 30, 2018 was as follows (in millions):

  
Three Months Ended June 30, 2018
 
  
As Reported
  
Balances Without
Adoption of New
Revenue Standard
  
Effect of Change
Higher / (Lower)
 
Revenues
         
Royalties
 
$
7.1
  
$
7.3
  
$
(0.2
)
Costs and expenses
            
General and administrative
 
$
2.0
  
$
2.0
  
$
-
 
Provision for income taxes
  
1.0
   
1.0
   
-
 
Net income
  
4.3
   
4.5
   
(0.2
)

  
Six Months Ended June 30, 2018
 
  
As Reported
  
Balances Without
Adoption of New
Revenue Standard
  
Effect of Change
Higher / (Lower)
 
Revenues
         
Royalties
 
$
14.2
  
$
15.0
  
$
(0.8
)
Costs and expenses
            
General and administrative
 
$
4.1
  
$
4.1
  
$
-
 
Provision for income taxes
  
2.0
   
2.2
   
(0.2
)
Net income
  
8.3
   
8.9
   
(0.6
)

In January 2016, the FASB issued new guidance on recognition and measurement of financial assets and financial liabilities. The new guidance will impact the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. All equity investments in unconsolidated entities (other than those accounted for under the equity method of accounting) will generally be measured at fair value with changes in fair value recognized through earnings. There will no longer be an available-for-sale classification (changes in fair value reported in other comprehensive income (loss) for equity securities with readily determinable fair values). In addition, the FASB clarified the need for a valuation allowance on deferred tax assets resulting from unrealized losses on available-for-sale debt securities. In general, the new guidance will require modified retrospective application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings. The adoption of the new standard as of January 1, 2018 had no impact on our consolidated financial statements and related disclosure as we do not currently have any available-for-sale equity investments.
 
Accounting Pronouncements Not Yet Adopted

In February 2016, FASB issued Accounting Standards Update (ASU) No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). Under the new guidance, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the lease commencement date: a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. Under the new guidance, lessor accounting is largely unchanged. Certain targeted improvements were made to align, where necessary, lessor accounting with the lessee accounting model and Topic 606, Revenue from Contracts with Customers. The new lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. Lessees will no longer be provided with a source of off-balance sheet financing. Public business entities should apply the amendments in ASU 2016-02 for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years (i.e., January 1, 2019, for a calendar year entity). Early application is permitted.  Lessees (for capital and operating leases) and lessors (for sales-type, direct financing, and operating leases) must apply a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. Lessees and lessors may not apply a full retrospective transition approach. We are currently evaluating the impact that the standard could have on our consolidated financial statements and related disclosures.

In June 2016, FASB issued ASU 2016-13, Financial Instruments - Credit Losses. The amendment revises the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in more timely recognition of losses on financial instruments, including, but not limited to, available for sale debt securities and accounts receivable. The Company is required to adopt this standard starting in the first quarter of fiscal year 2021. Early adoption is permitted. We are currently evaluating the impact of the adoption of this standard on our consolidated financial statements and related disclosures.
Cash, Cash Equivalents and Investments
Cash, Cash Equivalents and Investments

Cash equivalents include only securities having a maturity of 90 days or less at the time of purchase.  Investments are stated on an amortized cost basis. The Company limits its credit risk associated with cash, cash equivalents and investments by placing its investments with banks it believes are highly creditworthy and with highly rated money market funds, certificates of deposit, municipal bonds and corporate bonds. All investments are classified as held to maturity. As of June 30, 2018 and December 31, 2017, the amortized cost of these investments was $60.7 million and $57.7 million, respectively. No unrealized gains or losses were recorded in either period.
Fair Value Measurements
Fair Value Measurements

Management believes that the carrying amounts of the Company’s financial instruments, including cash, cash equivalents, held to maturity investments, accounts receivable, accounts payable and accrued expenses approximate fair value due to the short-term nature of those instruments. As of June 30, 2018 and December 31, 2017, there were no recorded unrealized gains or losses on our investments as they are classified as held to maturity. As of June 30, 2018 and December 31, 2017, amortized cost basis of the investments approximated their fair value. At June 30, 2018 and December 31, 2017, the amortized premium included in interest income was $288,000 and $673,000, respectively.

The following table presents the Company’s schedule of maturities at June 30, 2018 and December 31, 2017:
 
  
Maturities as of
June 30, 2018
  
Maturities as of
December 31, 2017
 
  
1 Year or
Less
  
Greater than 1
Year
  
1 Year or
Less
  
Greater than
1 Year
 
Municipal bonds
 
$
4,870,100
  
$
-
  
$
1,002,650
  
$
100,000
 
Corporate bonds
  
45,120,776
   
5,417,988
   
48,143,495
   
3,155,573
 
Certificates of deposit
  
3,595,048
   
1,745,495
   
2,827,826
   
2,490,401
 
Total
 
$
53,585,924
  
$
7,163,483
  
$
51,973,971
  
$
5,745,974
 
 
The authoritative literature for fair value measurements established a three-tier fair value hierarchy, which prioritizes the inputs in measuring fair value. These tiers are as follows: Level 1, defined as observable inputs such as quoted market prices in active markets; Level 2, defined as inputs other than the quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as significant unobservable inputs (entity developed assumptions) in which little or no market data exists.
 
As of June 30, 2018, the Company held certain investments that are required to be measured at fair value on a recurring basis. The following tables present the Company’s fair value hierarchy for these financial assets as of June 30, 2018 and December 31, 2017:
 
June 30, 2018
 
Type of Instrument
 
Fair Value
  
Level 1
  
Level 2
  
Level 3
 
               
Cash equivalents
 
Institutional Money Market
 
$
4,928,319
  
$
4,928,319
  
$
-
  
$
-
 
                   
Cash equivalents
 
Municipal Bonds
  
2,520,000
   
2,520,000
   
-
   
-
 
                   
Cash equivalents
 
Corporate Bonds
  
1,862,000
   
1,862,000
   
-
   
-
 
                   
Investments
 
Municipal Bonds
  
4,870,100
   
-
   
4,870,100
   
-
 
                   
Investments
 
Corporate Bonds
  
50,538,764
   
-
   
50,538,764
   
-
 
                   
Investments
 
Certificates of Deposit
  
5,340,543
   
5,340,543
   
-
   
-
 

December 31, 2017
 
Type of Instrument
 
Fair Value
  
Level 1
  
Level 2
  
Level 3
 
               
Cash equivalents
 
Institutional Money Market
 
$
3,108,549
  
$
3,108,549
  
$
-
  
$
-
 
                   
Cash equivalents
 
Municipal Bonds
  
800,000
   
-
   
800,000
   
-
 
                   
Investments
 
Municipal Bonds
  
1,102,650
   
-
   
1,102,650
   
-
 
                   
Investments
 
Corporate Bonds
  
51,299,068
   
-
   
51,299,068
   
-
 
                   
Investments
 
Certificates of Deposit
  
5,318,227
   
5,318,227
   
-
   
-
 
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 investments in FDIC insured certificates of deposits, municipal bonds and corporate bonds.

The Company is currently dependent on one customer, Endo, who generates almost all its revenues. For the three and six months ended June 30, 2018, licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately $7.1 million and $14.2 million, respectively, and for the three and six months ended June 30, 2017, the licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately $6.5 million and $14.2 million, respectively.

At June 30, 2018 and December 31, 2017, our accounts receivable balances from Endo were $12.9 million and $4.7 million, respectively.
Treasury Stock
Treasury Stock
 
The Company accounts for treasury stock under the cost method and includes treasury stock as a component of stockholders’ equity. For the six months ended June 30, 2018, there were no shares repurchased as compared to the repurchase of 9,283 shares at an average price of $51.57 in the corresponding 2017 period.
Receivables and Doubtful Accounts
Receivables and Doubtful Accounts
 
Trade accounts receivable are stated at the amount the Company expects to collect. We may maintain allowances for doubtful accounts for estimated losses resulting from the inability of our 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 Endo, our one large specialty pharmaceutical customer.  Endo has historically paid timely and has been a financially stable organization.  Due to the nature of the accounts receivable balance, we believe the risk of doubtful accounts is minimal.  If the financial condition of our customer were to deteriorate, adversely affecting its ability to make payments, additional allowances would be required.  We may 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, 2018 and December 31, 2017 our accounts receivable balance was $12.9 million and $4.7 million, respectively, and was from one customer, Endo. With the adoption of ASC 606 as of January 1, 2018, using the modified-retrospective adoption method, we recorded an adjustment to our accounts receivable balance of $7.6 million related to royalties associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)
Deferred Revenue
Deferred Revenue

With the adoption of ASC 606 using the modified retrospective adoption method as of January 1, 2018, the remaining deferred revenue balance associated with the mark-up on cost of goods sold for sales by non-affiliated sublicensees of Endo outside of the U.S. as of December 31, 2017 of $6.3 million was recorded as an adjustment to our retained earnings. Additionally, approximately $35,000 related to nonrefundable upfront product license fees for product candidates for which we have no remaining performance obligations was recognized during the second quarter of 2018. Finally, during the second quarter of 2018 we determined that the $100,000 related to a milestone payment withheld by Endo due to a foreign tax withholding was uncollectable and have reduced this amount to zero. As of June 30, 2018 and December 31, 2017, deferred revenue was zero and $6.4 million, respectively. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)
Reimbursable Third-Party Patent Costs
Reimbursable Third-Party Patent Costs

We accrue patent costs that are reimbursable to Endo by us under the License Agreement. We capitalize certain patent costs related to patent prosecution and maintenance and expense others. As of June 30, 2018 and December 31, 2017, our net reimbursable third party patent expense was $49,000 and zero, respectively.
Third-Party Royalties
Third-Party Royalties

We have entered into licensing and royalty agreements with third parties and agreed to pay certain royalties on net sales of products for specific indications. The royalty rates differ from agreement to agreement and, in certain cases, have been redacted with the permission of the SEC.  No assumptions should be made that any disclosed royalty rate payable to a particular third party is the same or similar with respect to any royalty rate payable to any other third parties. We accrue third-party royalty expenses on net sales reported to us by Endo. Third-party royalty costs are generally expensed under general and administrative in the quarter that the net sales have occurred. For the three and six month periods ended June 30, 2018, third-party royalty expenses were $0.5 million and $1.0 million, respectively. For the three and six month periods ended June 30, 2017, third-party royalty expenses were $0.4 million and $0.9 million, respectively. With the adoption of ASC 606 as of January 1, 2018 using the modified-retrospective adoption method, we recorded an adjustment to our retained earnings for third party royalties expense of $0.5 million associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag. Our third-party royalty expense under general and administrative expenses may increase if net sales by Endo and its partners for XIAFLEX and Xiapex increase and potential new indications for XIAFLEX and Xiapex are approved, marketed and sold. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)
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 in connection with 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 of $600,000, all of which have been paid as of June 30, 2018.  Royalty obligations terminate five years after first commercial sale which occurred in January 2014. The Company amortizes long-term contracts with finite lives in a manner that reflects the pattern in which the economic benefits of the assets are consumed or otherwise used up. Dr. Gelbard’s agreement is amortized based on an income forecast method by estimating sales of XIAFLEX and Xiapex for Peyronie’s disease on an annual basis as measured by the proportion of the total estimated sales over the five year period. For the three and six months ended June 30, 2018 and 2017, we amortized approximately $0.5 million and $1.0 million related to this agreement, respectively and $0.4 million and $0.7 million for the three and six months ended June 30, 2017. With the adoption of ASC 606 as of January 1, 2018 using the modified-retrospective adoption method, we recorded an adjustment to our capitalized balance of $0.4 million related to royalties associated with the net sales of XIAFLEX that occurred during the fourth quarter of 2017 thereby eliminating the one quarter lag. As of June 30, 2018 and December 31, 2017, the remaining capitalized balances were approximately $1.1 million and $2.5 million, respectively. We perform an evaluation of the recoverability of the carrying value to determine if facts and circumstances indicate that the carrying value of the assets may be impaired and if any adjustment is warranted.  As of June 30, 2018, there was no indicator that an impairment existed. (For more a more detailed discussion regarding ASC 606 see Note 2- SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - RECENT ACCOUNTING PRONOUNCEMENTS - Accounting Pronouncements Adopted.)
Research and Development Expenses
Research and Development Expenses

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 consultants. 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 one stock-based compensation plan 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 stock options including stock options and common stock issued to our employees and directors under our stock plans. ASC 718 requires companies to estimate the fair value of stock option 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 condensed consolidated statements of operations.
 
Under ASC 718, we estimate the fair value of our employee stock option 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 option award, we consider the vesting period for the award, our recent historical experience of employee stock option exercises (including forfeitures) and the expected volatility of our common stock.  As required under the accounting rules, we review our estimates at each grant date and, as a result, the valuation assumptions that we use to value employee stock-based awards granted in future periods may change. For the six months ended June 30, 2018, we granted a total of 31,500 stock options with a weighted average grant date fair value of $18.00 per share.
 
The assumptions used in the valuation of stock options granted during the six months ended June 30, 2018 were as follows:

 
Six Months Ended
June 30, 2018
 
Risk-free interest rate
 
2.62% to 2.81
%
Expected term of option
 
6.25 years
 
Expected stock price volatility
 
39.6% to 39.7
%
Expected dividend yield
 
$
0.0
 
 
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 in general and administrative expenses was approximately $63,000 and $96,000 for the three and six month periods ended June 30, 2018 and approximately $33,000 and $67,000 for the three and six months ended June 30, 2017, respectively.

Stock Option Activity

A summary of our stock option activity during the six months ended June 30, 2018 is presented below:
 
  
Shares
  
Weighted
Average
Exercise
Price
  
Weighted
Average
Remaining
Contractual
Term
  
Aggregate
Intrinsic
Value
 
Outstanding at December 31, 2017
  
232,000
  
$
21.56
   
2.52
  
$
5,050,990
 
Grants
  
31,500
   
41.79
   
-
   
-
 
Exercised
  
(55,000
)
  
15.64
   
-
   
1,454,650
 
Forfeitures or expirations
  
-
   
-
   
-
   
-
 
Outstanding at June 30, 2018
  
208,500
  
$
26.18
   
3.37
  
$
3,895,465
 
Exercisable at June 30, 2018
  
169,500
  
$
22.77
   
2.04
  
$
3,744,550
 

During the six months ended June 30, 2018 and 2017, the Company received approximately $860,000 and $258,000, respectively, from stock options exercised by option holders.

Aggregate intrinsic value represents the total pre-tax intrinsic value based on the closing price of our common stock of $44.86 on June 29, 2018, which would have been received by the option holders had all option holders exercised their options as of that date. We have approximately $611,000 in unrecognized compensation cost related to stock options outstanding as of June 30, 2018, which we expect to recognize over the next 3.31 years.
Property and Equipment
Property and Equipment

Property and equipment are stated at cost, less accumulated depreciation. Machinery and equipment, furniture and fixtures, and autos are depreciated on a straight-line basis over their estimated useful lives of five to ten years. Leasehold improvements are amortized over the lesser of their estimated useful lives or the remaining life of the lease. At each of June 30, 2018 and December 31, 2017, property and equipment were fully depreciated.
Comprehensive Income
Comprehensive Income

For each of the three and six month periods ended June 30, 2018 and 2017, we had no components of other comprehensive income other than net income itself.
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.

The Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such position are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon the ultimate settlement. As of June 30, 2018 and December 31, 2017, the Company has not recorded any unrecognized tax benefits.
Commitments and Contingencies
Commitments and Contingencies

On November 6, 2017, the Company entered into an agreement with the Landlord to extend the term of the lease to the Headquarters for an additional one year period (the “Extended Lease Agreement”). The one year extension will end on November 30, 2018. Pursuant to the Extended Lease Agreement, the base rent is $11,165 per month and the Company may cancel the lease with three months’ prior written notice to the Landlord at any time during the term.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
6 Months Ended
Jun. 30, 2018
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
New Accounting Pronouncements and Impact of Adoption on Financial Statements
The Company recorded the following cumulative effect as of January 1, 2018, itemized here (in millions):
 
  
As reported
December 31, 2017
  
Adjustments
  
Adjusted
January 1, 2018
 
Accounts receivable
 
$
4.7
  
$
7.6
(1) 
 
$
12.3
 
Deferred revenue
  
(6.4
)
  
6.3
(2) 
  
(0.1
)
Deferred royalty buy-down
  
(2.5
)
  
(0.4
)(3)
  
(2.9
)
Accounts payable and accrued expenses -third party royalties
  
(0.4
)
  
(0.5
)(3)
  
(0.9
)
Deferred tax assets, net
  
1.7
   
(1.3
)(4)
  
0.4
 
Income tax payable
  
-
   
(1.4
)(5)
  
(1.4
)
             
Retained earnings adjustment
 
$
(2.9
)
 
$
10.3
  
$
7.4
 
 
(1)
This adjustment represents the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017.
(2)
Represents the remaining deferred revenue balance of the prepaid mark-up on cost of goods sold based on sales by non-affiliated sublicensees of Endo outside of the U.S.
(3)
Represents the amortization of the royalty buy-down and third party royalties expense associated royalty revenues based on XIALFLEX net sales reported to us by Endo for the fourth quarter of 2017.
(4)
To reverse a deferred tax asset associated with the deferred revenue balance of the prepaid mark-up on cost of goods sold by non-affiliated sublicensees of Endo outside of the U.S.
(5)
To create a tax liability associated the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017.

At June 30, 2018, contract assets of $7.1 million for which there’s an unconditional right to receive payment was included in accounts receivable on the condensed consolidated balance sheet.
 
In accordance with the new revenue standard requirements, the impact of adoption on our condensed consolidated balance sheet was as follows (in millions):

  
June 30, 2018
 
  
As Reported
  
Balances Without
Adoption of New
Revenue Standard
  
Effect of Change
Higher / (Lower)
 
Assets
         
Accounts receivable
 
$
12.9
  
$
5.8
  
$
7.1
 
Deferred royalty buy-down
  
1.1
   
1.3
   
(0.2
)
Deferred tax assets
  
0.3
   
1.5
   
(1.2
)
Liabilities
            
Accounts payable and accrued expenses
  
1.6
   
1.1
   
0.5
 
Deferred revenue
  
-
   
0.9
   
(0.9
)
Income tax payable
  
0.8
   
0.5
   
(1.3
)
Deferred revenue, long term
  
-
   
4.9
   
(4.9
)
Equity
            
Retained earnings
  
60.4
   
50.7
   
9.7
 
 
In accordance with the new revenue standard requirements, the impact of adoption on our condensed consolidated statement of operations for the three and six months ended June 30, 2018 was as follows (in millions):

  
Three Months Ended June 30, 2018
 
  
As Reported
  
Balances Without
Adoption of New
Revenue Standard
  
Effect of Change
Higher / (Lower)
 
Revenues
         
Royalties
 
$
7.1
  
$
7.3
  
$
(0.2
)
Costs and expenses
            
General and administrative
 
$
2.0
  
$
2.0
  
$
-
 
Provision for income taxes
  
1.0
   
1.0
   
-
 
Net income
  
4.3
   
4.5
   
(0.2
)

  
Six Months Ended June 30, 2018
 
  
As Reported
  
Balances Without
Adoption of New
Revenue Standard
  
Effect of Change
Higher / (Lower)
 
Revenues
         
Royalties
 
$
14.2
  
$
15.0
  
$
(0.8
)
Costs and expenses
            
General and administrative
 
$
4.1
  
$
4.1
  
$
-
 
Provision for income taxes
  
2.0
   
2.2
   
(0.2
)
Net income
  
8.3
   
8.9
   
(0.6
)
Maturities
The following table presents the Company’s schedule of maturities at June 30, 2018 and December 31, 2017:
 
  
Maturities as of
June 30, 2018
  
Maturities as of
December 31, 2017
 
  
1 Year or
Less
  
Greater than 1
Year
  
1 Year or
Less
  
Greater than
1 Year
 
Municipal bonds
 
$
4,870,100
  
$
-
  
$
1,002,650
  
$
100,000
 
Corporate bonds
  
45,120,776
   
5,417,988
   
48,143,495
   
3,155,573
 
Certificates of deposit
  
3,595,048
   
1,745,495
   
2,827,826
   
2,490,401
 
Total
 
$
53,585,924
  
$
7,163,483
  
$
51,973,971
  
$
5,745,974
 
Fair Value Assets Measured on Recurring Basis
As of June 30, 2018, the Company held certain investments that are required to be measured at fair value on a recurring basis. The following tables present the Company’s fair value hierarchy for these financial assets as of June 30, 2018 and December 31, 2017:
 
June 30, 2018
 
Type of Instrument
 
Fair Value
  
Level 1
  
Level 2
  
Level 3
 
               
Cash equivalents
 
Institutional Money Market
 
$
4,928,319
  
$
4,928,319
  
$
-
  
$
-
 
                   
Cash equivalents
 
Municipal Bonds
  
2,520,000
   
2,520,000
   
-
   
-
 
                   
Cash equivalents
 
Corporate Bonds
  
1,862,000
   
1,862,000
   
-
   
-
 
                   
Investments
 
Municipal Bonds
  
4,870,100
   
-
   
4,870,100
   
-
 
                   
Investments
 
Corporate Bonds
  
50,538,764
   
-
   
50,538,764
   
-
 
                   
Investments
 
Certificates of Deposit
  
5,340,543
   
5,340,543
   
-
   
-
 

December 31, 2017
 
Type of Instrument
 
Fair Value
  
Level 1
  
Level 2
  
Level 3
 
               
Cash equivalents
 
Institutional Money Market
 
$
3,108,549
  
$
3,108,549
  
$
-
  
$
-
 
                   
Cash equivalents
 
Municipal Bonds
  
800,000
   
-
   
800,000
   
-
 
                   
Investments
 
Municipal Bonds
  
1,102,650
   
-
   
1,102,650
   
-
 
                   
Investments
 
Corporate Bonds
  
51,299,068
   
-
   
51,299,068
   
-
 
                   
Investments
 
Certificates of Deposit
  
5,318,227
   
5,318,227
   
-
   
-
 
Assumptions Used in Valuation of Stock Options Granted
The assumptions used in the valuation of stock options granted during the six months ended June 30, 2018 were as follows:

 
Six Months Ended
June 30, 2018
 
Risk-free interest rate
 
2.62% to 2.81
%
Expected term of option
 
6.25 years
 
Expected stock price volatility
 
39.6% to 39.7
%
Expected dividend yield
 
$
0.0
 
Stock Option Activity
A summary of our stock option activity during the six months ended June 30, 2018 is presented below:
 
  
Shares
  
Weighted
Average
Exercise
Price
  
Weighted
Average
Remaining
Contractual
Term
  
Aggregate
Intrinsic
Value
 
Outstanding at December 31, 2017
  
232,000
  
$
21.56
   
2.52
  
$
5,050,990
 
Grants
  
31,500
   
41.79
   
-
   
-
 
Exercised
  
(55,000
)
  
15.64
   
-
   
1,454,650
 
Forfeitures or expirations
  
-
   
-
   
-
   
-
 
Outstanding at June 30, 2018
  
208,500
  
$
26.18
   
3.37
  
$
3,895,465
 
Exercisable at June 30, 2018
  
169,500
  
$
22.77
   
2.04
  
$
3,744,550
 
XML 23 R14.htm IDEA: XBRL DOCUMENT v3.10.0.1
NET INCOME PER SHARE (Tables)
6 Months Ended
Jun. 30, 2018
NET INCOME PER SHARE [Abstract]  
Number of Common Equivalent Shares Excluded from the Calculation of Diluted Net Income Per Share
The following table summarizes the number of common equivalent shares that were excluded for the calculation of diluted net income per share reported in the condensed consolidated statement of operations.

  
Three Months Ended
June 30,
  
Six Months Ended
June 30,
 
  
2018
  
2017
  
2018
  
2017
 
Stock options
  
-
   
20,000
   
-
   
20,000
 
XML 24 R15.htm IDEA: XBRL DOCUMENT v3.10.0.1
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables)
6 Months Ended
Jun. 30, 2018
ACCOUNTS PAYABLE AND ACCRUED EXPENSES [Abstract]  
Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following:

  
June 30,
2018
  
December 31,
2017
 
Trade accounts payable
 
$
34,553
  
$
152,542
 
Accrued legal and other professional fees
  
219,223
   
150,691
 
Accrued payroll and related costs
  
182,746
   
215,322
 
Third party royalties
  
1,018,308
   
329,211
 
Other accruals
  
136,877
   
86,232
 
Total
 
$
1,591,707
  
$
933,998
 
XML 25 R16.htm IDEA: XBRL DOCUMENT v3.10.0.1
PATENT COSTS (Tables)
6 Months Ended
Jun. 30, 2018
PATENT COSTS [Abstract]  
Net Patent Costs
For each period presented below, net patent costs consisted of:

  
June 30,
2018
  
December 31,
2017
 
Patents
  
1,004,502
  
$
925,016
 
Accumulated amortization
  
(561,534
)
  
(527,023
)
  
$
442,968
  
$
397,993
 
Estimated Aggregate Future Amortization Expense
The estimated aggregate amortization expense for the remaining six months of 2018 and each of the years below is approximately as follows:
 
July 1, 2018 - December 31, 2018
 
$
36,000
 
2019
  
69,700
 
2020
  
53,700
 
2021
  
37,800
 
2022
  
37,800
 
Thereafter
  
208,000
 
XML 26 R17.htm IDEA: XBRL DOCUMENT v3.10.0.1
ORGANIZATION AND DESCRIPTION OF BUSINESS (Details) - USD ($)
$ in Thousands
Jun. 30, 2018
Dec. 31, 2017
Dec. 31, 2015
Organization and Description of Business [Abstract]      
Deferred revenue $ 0 $ 6,400  
Endo [Member]      
Organization and Description of Business [Abstract]      
Deferred revenue   $ (6,400)  
Endo [Member] | Licensing Revenues [Member]      
Organization and Description of Business [Abstract]      
Deferred revenue     $ 8,250
Opt-in fee receivable for each indication 500    
Regular opt-in fee receivable for each indication $ 750    
XML 27 R18.htm IDEA: XBRL DOCUMENT v3.10.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Revenue Recognition, Cumulative Effect (Details) - USD ($)
Jun. 30, 2018
Dec. 31, 2017
Balance Sheets [Abstract]    
Contract assets $ 7,100,000  
Accounts receivable 12,893,893 [1] $ 4,655,105
Deferred revenue 0 6,400,000
Deferred royalty buy-down (1,100,000) (2,500,000)
Deferred tax assets, net 321,603 [1] 1,739,706
Income tax payable 801,800 [1] 68,733
Retained earnings adjustment 60,402,721 [1] 41,939,115
Endo [Member]    
Balance Sheets [Abstract]    
Accounts receivable 12,893,893 4,655,105
Deferred revenue   (6,400,000)
Deferred royalty buy-down   (2,500,000)
Accounts payable and accrued expenses -third party royalties   (400,000)
Deferred tax assets, net   1,739,706
Income tax payable   0
Retained earnings adjustment   (2,900,000)
ASU 2014-09 [Member] | Endo [Member]    
Balance Sheets [Abstract]    
Accounts receivable   12,300,000
Deferred revenue   (100,000)
Deferred royalty buy-down   (2,900,000)
Accounts payable and accrued expenses -third party royalties   (900,000)
Deferred tax assets, net   400,000
Income tax payable   (1,400,000)
Retained earnings adjustment   7,400,000
Adjustments / Effect of Change Higher / (Lower) [Member] | ASU 2014-09 [Member]    
Balance Sheets [Abstract]    
Accounts receivable 7,100,000  
Deferred tax assets, net (1,200,000)  
Income tax payable (1,300,000)  
Retained earnings adjustment $ 9,700,000  
Adjustments / Effect of Change Higher / (Lower) [Member] | ASU 2014-09 [Member] | Endo [Member]    
Balance Sheets [Abstract]    
Accounts receivable [2]   7,600,000
Deferred revenue [3]   6,300,000
Deferred royalty buy-down [4]   (400,000)
Accounts payable and accrued expenses -third party royalties [4]   (500,000)
Deferred tax assets, net [5]   (1,300,000)
Income tax payable [6]   (1,400,000)
Retained earnings adjustment   $ 10,300,000
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
[2] This adjustment represents the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017.
[3] Represents the remaining deferred revenue balance of the prepaid mark-up on cost of goods sold based on sales by non-affiliated sublicensees of Endo outside of the U.S.
[4] Represents the amortization of the royalty buy-down and third party royalties expense associated royalty revenues based on XIALFLEX net sales reported to us by Endo for the fourth quarter of 2017.
[5] To reverse a deferred tax asset associated with the deferred revenue balance of the prepaid mark-up on cost of goods sold by non-affiliated sublicensees of Endo outside of the U.S.
[6] To create a tax liability associated the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017.
XML 28 R19.htm IDEA: XBRL DOCUMENT v3.10.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Revenue Recognition, Impact on Condensed Consolidated Balance Sheet (Details) - USD ($)
Jun. 30, 2018
Dec. 31, 2017
Assets [Abstract]    
Accounts receivable $ 12,893,893 [1] $ 4,655,105
Deferred royalty buy-down 1,124,990 [1] 1,794,126
Deferred tax assets, net 321,603 [1] 1,739,706
Liabilities [Abstract]    
Accounts payable and accrued expenses 1,591,707 [1] 933,998
Deferred revenue 0 [1] 1,057,979
Income tax payable 801,800 [1] 68,733
Deferred revenue, long term 0 [1] 5,340,708
Equity [Abstract]    
Retained earnings 60,402,721 [1] $ 41,939,115
Adjusted / Balances Without Adoption of New Revenue Standard [Member] | ASU 2014-09 [Member]    
Assets [Abstract]    
Accounts receivable 5,800,000  
Deferred royalty buy-down 1,300,000  
Deferred tax assets, net 1,500,000  
Liabilities [Abstract]    
Accounts payable and accrued expenses 1,100,000  
Deferred revenue 900,000  
Income tax payable 500,000  
Deferred revenue, long term 4,900,000  
Equity [Abstract]    
Retained earnings 50,700,000  
Adjustments / Effect of Change Higher / (Lower) [Member] | ASU 2014-09 [Member]    
Assets [Abstract]    
Accounts receivable 7,100,000  
Deferred royalty buy-down (200,000)  
Deferred tax assets, net (1,200,000)  
Liabilities [Abstract]    
Accounts payable and accrued expenses 500,000  
Deferred revenue (900,000)  
Income tax payable (1,300,000)  
Deferred revenue, long term (4,900,000)  
Equity [Abstract]    
Retained earnings $ 9,700,000  
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
XML 29 R20.htm IDEA: XBRL DOCUMENT v3.10.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Revenue Recognition, Impact on Condensed Consolidated Statement of Operations (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2018
Jun. 30, 2017
Jun. 30, 2018
Jun. 30, 2017
Revenues [Abstract]        
Total revenues $ 7,096,409 [1] $ 6,535,516 $ 14,185,818 [1] $ 14,226,135
Costs and expenses [Abstract]        
General and administrative 1,985,212 [1] 2,315,283 4,054,845 [1] 4,741,000
Provision for income taxes 954,465 [1] 1,422,829 2,033,039 [1] 3,192,512
Net income 4,300,667 [1] 2,624,091 8,279,271 [1] 5,968,844
Royalties [Member]        
Revenues [Abstract]        
Total revenues 7,061,139 [1] $ 6,531,107 14,146,139 [1] $ 14,217,317
Adjusted / Balances Without Adoption of New Revenue Standard [Member] | ASU 2014-09 [Member]        
Revenues [Abstract]        
Total revenues 7,300,000   15,000,000  
Costs and expenses [Abstract]        
General and administrative 2,000,000   4,100,000  
Provision for income taxes 1,000,000   2,200,000  
Net income 4,500,000   8,900,000  
Adjustments / Effect of Change Higher / (Lower) [Member] | ASU 2014-09 [Member]        
Revenues [Abstract]        
Total revenues (200,000)   (800,000)  
Costs and expenses [Abstract]        
General and administrative 0   0  
Provision for income taxes 0   (200,000)  
Net income $ (200,000)   $ (600,000)  
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
XML 30 R21.htm IDEA: XBRL DOCUMENT v3.10.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Cash, Cash Equivalents and Investments (Details) - USD ($)
Jun. 30, 2018
Dec. 31, 2017
Cash, Cash Equivalents and Investments [Abstract]    
Aggregate fair value of investments $ 60,700,000 $ 57,700,000
Held-to-maturity securities, unrecognized gain 0 0
Held-to-maturity securities, unrecognized loss $ 0 $ 0
XML 31 R22.htm IDEA: XBRL DOCUMENT v3.10.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Fair Value Measurements (Details) - USD ($)
6 Months Ended 12 Months Ended
Jun. 30, 2018
Dec. 31, 2017
Fair Value Measurements [Abstract]    
Held-to-maturity securities, unrecognized loss $ 0 $ 0
Amortized premium included in interest income (288,000) (673,000)
Schedule of Held-to-maturity Securities [Line Items]    
Held-to-maturity securities, current 53,585,924 51,973,971
Held-to-maturity securities, noncurrent 7,163,483 5,745,974
Recurring [Member] | Institutional Money Market [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 4,928,319 3,108,549
Recurring [Member] | Municipal Bonds [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 2,520,000 800,000
Investments 4,870,100 1,102,650
Recurring [Member] | Corporate Bonds [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 1,862,000  
Investments 50,538,764 51,299,068
Recurring [Member] | Certificates of Deposit [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Investments 5,340,543 5,318,227
Recurring [Member] | Level 1 [Member] | Institutional Money Market [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 4,928,319 3,108,549
Recurring [Member] | Level 1 [Member] | Municipal Bonds [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 2,520,000 0
Investments 0 0
Recurring [Member] | Level 1 [Member] | Corporate Bonds [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 1,862,000  
Investments 0 0
Recurring [Member] | Level 1 [Member] | Certificates of Deposit [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Investments 5,340,543 5,318,227
Recurring [Member] | Level 2 [Member] | Institutional Money Market [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 0 0
Recurring [Member] | Level 2 [Member] | Municipal Bonds [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 0 800,000
Investments 4,870,100 1,102,650
Recurring [Member] | Level 2 [Member] | Corporate Bonds [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 0  
Investments 50,538,764 51,299,068
Recurring [Member] | Level 2 [Member] | Certificates of Deposit [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Investments 0 0
Recurring [Member] | Level 3 [Member] | Institutional Money Market [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 0 0
Recurring [Member] | Level 3 [Member] | Municipal Bonds [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 0 0
Investments 0 0
Recurring [Member] | Level 3 [Member] | Corporate Bonds [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Cash equivalents 0  
Investments 0 0
Recurring [Member] | Level 3 [Member] | Certificates of Deposit [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Investments 0 0
Municipal Bonds [Member]    
Schedule of Held-to-maturity Securities [Line Items]    
Held-to-maturity securities, current 4,870,100 1,002,650
Held-to-maturity securities, noncurrent 0 100,000
Corporate Bonds [Member]    
Schedule of Held-to-maturity Securities [Line Items]    
Held-to-maturity securities, current 45,120,776 48,143,495
Held-to-maturity securities, noncurrent 5,417,988 3,155,573
Certificates of Deposit [Member]    
Schedule of Held-to-maturity Securities [Line Items]    
Held-to-maturity securities, current 3,595,048 2,827,826
Held-to-maturity securities, noncurrent $ 1,745,495 $ 2,490,401
XML 32 R23.htm IDEA: XBRL DOCUMENT v3.10.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Concentration of Credit Risk and Major Customers and Revenue Recognition (Details)
3 Months Ended 6 Months Ended
Jun. 30, 2018
USD ($)
Customer
Jun. 30, 2017
USD ($)
Jun. 30, 2018
USD ($)
Customer
Jun. 30, 2017
USD ($)
Dec. 31, 2017
USD ($)
Concentration Risk [Line Items]          
Total revenues $ 7,096,409 [1] $ 6,535,516 $ 14,185,818 [1] $ 14,226,135  
Accounts receivable 12,893,893 [1]   12,893,893 [1]   $ 4,655,105
Royalties [Member]          
Concentration Risk [Line Items]          
Total revenues 7,061,139 [1] 6,531,107 14,146,139 [1] 14,217,317  
Licensing Revenues [Member]          
Concentration Risk [Line Items]          
Total revenues $ 35,270 [1] 4,409 $ 39,679 [1] 8,818  
Endo [Member]          
Concentration Risk [Line Items]          
Number of customers | Customer 1   1    
Total revenues $ 7,061,139 $ 6,531,107 $ 14,146,139 $ 14,217,317  
Accounts receivable $ 12,893,893   $ 12,893,893   $ 4,655,105
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
XML 33 R24.htm IDEA: XBRL DOCUMENT v3.10.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Treasury Stock, Receivables and Doubtful Accounts and Deferred Revenue (Details) - USD ($)
6 Months Ended
Jun. 30, 2018
Jun. 30, 2017
Dec. 31, 2017
Dec. 31, 2015
Treasury Stock [Abstract]        
Treasury stock purchased (in shares) 0 9,283    
Average price of share (in dollars per share)   $ 51.57    
Receivables and Doubtful Accounts [Abstract]        
Accounts receivable $ 12,893,893 [1]   $ 4,655,105  
Deferred Revenue [Abstract]        
Deferred revenue 0   6,400,000  
Adjustments / Effect of Change Higher / (Lower) [Member] | ASU 2014-09 [Member]        
Receivables and Doubtful Accounts [Abstract]        
Accounts receivable 7,100,000      
Nonrefundable Upfront Product License Fees [Member]        
Deferred Revenue [Abstract]        
Deferred revenue 35,000      
Milestone Payment Due Foreign Tax Withholding [Member]        
Deferred Revenue [Abstract]        
Deferred revenue 0      
Provision for receivable uncollectable 100,000      
Endo [Member]        
Receivables and Doubtful Accounts [Abstract]        
Accounts receivable $ 12,893,893   4,655,105  
Deferred Revenue [Abstract]        
Deferred revenue     (6,400,000)  
Endo [Member] | ASU 2014-09 [Member]        
Receivables and Doubtful Accounts [Abstract]        
Accounts receivable     12,300,000  
Deferred Revenue [Abstract]        
Deferred revenue     (100,000)  
Endo [Member] | Adjustments / Effect of Change Higher / (Lower) [Member] | ASU 2014-09 [Member]        
Receivables and Doubtful Accounts [Abstract]        
Accounts receivable [2]     7,600,000  
Deferred Revenue [Abstract]        
Deferred revenue [3]     $ 6,300,000  
Endo [Member] | Licensing Revenues [Member]        
Deferred Revenue [Abstract]        
Deferred revenue       $ 8,250,000
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
[2] This adjustment represents the elimination of the one quarter lag by recognizing royalty revenues based on of XIALFLEX net sales and mark-up on cost of goods sold revenues reported to us by Endo for the fourth quarter of 2017.
[3] Represents the remaining deferred revenue balance of the prepaid mark-up on cost of goods sold based on sales by non-affiliated sublicensees of Endo outside of the U.S.
XML 34 R25.htm IDEA: XBRL DOCUMENT v3.10.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Reimbursable Third-Party Patent Costs, Third party Royalties and Royalty Buy-Down (Details)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2018
USD ($)
Jun. 30, 2017
USD ($)
Mar. 31, 2012
USD ($)
Payment
Jun. 30, 2018
USD ($)
Payment
Jun. 30, 2017
USD ($)
Dec. 31, 2017
USD ($)
Reimbursable Third-Party Patent Costs [Abstract]            
Accrued patent costs $ 49     $ 49   $ 0
Third-Party Royalties [Abstract]            
Royalty expenses 500 $ 400   1,000 $ 900  
Royalty Buy-Down [Abstract]            
Initial payment for royalty buy down     $ 1,500 $ 600    
Number of additional cash payments for royalty buy-down | Payment     5      
Number of cash payments made for royalty obligation | Payment       5    
Deferred costs, amortization period       5 years    
Amount amortized related to agreement 500 $ 400   $ 1,000 $ 700  
Deferred royalty buy-down $ 1,100     $ 1,100   $ 2,500
XML 35 R26.htm IDEA: XBRL DOCUMENT v3.10.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Stock-Based Compensation (Details)
3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2018
USD ($)
$ / shares
shares
Jun. 30, 2017
USD ($)
Jun. 30, 2018
USD ($)
Plan
$ / shares
shares
Jun. 30, 2017
USD ($)
Dec. 31, 2017
USD ($)
$ / shares
shares
Jun. 29, 2018
$ / shares
Share-Based Compensation [Abstract]            
Number of stock based compensation plans | Plan     1      
Additional Disclosures [Abstract]            
Proceeds from stock option exercises     $ 860,050 [1] $ 258,250    
Closing price of common stock (in dollars per share) | $ / shares           $ 44.86
General and Administrative [Member]            
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]            
Stock-based compensation expense $ 63,000 $ 33,000 $ 96,000 67,000    
Stock Options [Member]            
Weighted Average Grant Date Fair Value [Abstract]            
Weighted average grant date fair value (in dollars per share) | $ / shares     $ 18.00      
Assumptions Used in Valuation of Stock Options Granted [Abstract]            
Risk-free interest rate, minimum     2.62%      
Risk-free interest rate, maximum     2.81%      
Expected term of option     6 years 3 months      
Expected stock price volatility, minimum     39.60%      
Expected stock price volatility, maximum     39.70%      
Expected dividend yield     0.00%      
Stock Options Activity [Roll Forward]            
Outstanding, beginning of period (in shares) | shares     232,000      
Grants (in shares) | shares     31,500      
Exercised (in shares) | shares     (55,000)      
Forfeitures or expirations (in shares) | shares     0      
Outstanding, end of period (in shares) | shares 208,500   208,500   232,000  
Exercisable, end of period (in shares) | shares 169,500   169,500      
Weighted Average Exercise Price [Roll Forward]            
Outstanding, beginning of period (in dollars per share) | $ / shares     $ 21.56      
Grants (in dollars per share) | $ / shares     41.79      
Exercised (in dollars per share) | $ / shares     15.64      
Forfeitures or expirations (in dollars per share) | $ / shares     0      
Outstanding, end of period (in dollars per share) | $ / shares $ 26.18   26.18   $ 21.56  
Exercisable, end of period (in dollars per share) | $ / shares $ 22.77   $ 22.77      
Weighted Average Remaining Contractual Term [Roll Forward]            
Outstanding     3 years 4 months 13 days   2 years 6 months 7 days  
Grants     0 years      
Exercised     0 years      
Forfeitures or expirations     0 years      
Exercisable     2 years 14 days      
Aggregate Intrinsic Value [Roll Forward]            
Outstanding, beginning of period     $ 5,050,990      
Grants     0      
Exercised     1,454,650      
Forfeitures or expirations     0      
Outstanding, end of period $ 3,895,465   3,895,465   $ 5,050,990  
Exercisable, end of period 3,744,550   3,744,550      
Additional Disclosures [Abstract]            
Proceeds from stock option exercises     860,000 $ 258,000    
Unrecognized compensation cost $ 611,000   $ 611,000      
Recognized compensation period     3 years 3 months 22 days      
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
XML 36 R27.htm IDEA: XBRL DOCUMENT v3.10.0.1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES, Property and Equipment, Comprehensive Income, Provision for Income Taxes and Commitments and Contingencies (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2018
Jun. 30, 2017
Jun. 30, 2018
Jun. 30, 2017
Dec. 31, 2017
Comprehensive Income [Abstract]          
Other comprehensive income $ 0 $ 0 $ 0 $ 0  
Income Taxes [Abstract]          
Unrecognized tax benefits $ 0   $ 0   $ 0
Commitments and Contingencies [Abstract]          
Additional lease term extension period 1 year   1 year    
Monthly base rent     $ 11,165    
Notice period to cancel lease agreements     3 months    
Minimum [Member]          
Property, Plant and Equipment [Line Items]          
Estimated useful life     5 years    
Maximum [Member]          
Property, Plant and Equipment [Line Items]          
Estimated useful life     10 years    
XML 37 R28.htm IDEA: XBRL DOCUMENT v3.10.0.1
NET INCOME PER SHARE (Details) - Stock Options [Member] - $ / shares
3 Months Ended 6 Months Ended
Oct. 25, 2017
Jun. 30, 2018
Jun. 30, 2017
Jun. 30, 2018
Jun. 30, 2017
Net Income Per Share [Abstract]          
Antidilutive securities excluded from earnings per share calculation (in shares)   0 20,000 0 20,000
Exercise Price of $29.21 [Member]          
Net Income Per Share [Abstract]          
Exercise price (in dollars per share)     $ 29.21   $ 29.21
Options cancelled (in shares) (20,000)        
XML 38 R29.htm IDEA: XBRL DOCUMENT v3.10.0.1
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($)
Jun. 30, 2018
Dec. 31, 2017
Accounts payable and accrued expenses [Abstract]    
Trade accounts payable $ 34,553 $ 152,542
Accrued legal and other professional fees 219,223 150,691
Accrued payroll and related costs 182,746 215,322
Third party royalties 1,018,308 329,211
Other accruals 136,877 86,232
Total $ 1,591,707 [1] $ 933,998
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
XML 39 R30.htm IDEA: XBRL DOCUMENT v3.10.0.1
PATENT COSTS (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2018
Jun. 30, 2017
Jun. 30, 2018
Jun. 30, 2017
Dec. 31, 2017
Net Patent Costs [Abstract]          
Net patent costs $ 442,968 [1]   $ 442,968 [1]   $ 397,993
Patents [Member]          
Net Patent Costs [Abstract]          
Patents 1,004,502   1,004,502   925,016
Accumulated amortization (561,534)   (561,534)   (527,023)
Net patent costs 442,968   442,968   $ 397,993
Amortization expense for patents 18,000 $ 10,000 35,000 $ 20,000  
Estimated aggregate amortization expense [Abstract]          
July 1, 2018 - December 31, 2018 36,000   36,000    
2019 69,700   69,700    
2020 53,700   53,700    
2021 37,800   37,800    
2022 37,800   37,800    
Thereafter $ 208,000   $ 208,000    
Patents [Member] | Minimum [Member]          
Patent Cost [Abstract]          
Estimated useful lives     2 years    
Patents [Member] | Maximum [Member]          
Patent Cost [Abstract]          
Estimated useful lives     10 years    
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
XML 40 R31.htm IDEA: XBRL DOCUMENT v3.10.0.1
PROVISION FOR INCOME TAXES (Details) - USD ($)
3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2018
Jun. 30, 2017
Jun. 30, 2018
Jun. 30, 2017
Dec. 31, 2017
PROVISION FOR INCOME TAXES [Abstract]          
Provision for income taxes $ 954,465 [1] $ 1,422,829 $ 2,033,039 [1] $ 3,192,512  
Deferred tax assets 300,000   300,000   $ 1,700,000
Unrecognized tax benefits $ 0   0   $ 0
Interest and penalties     $ 0    
Estimated effective tax rate 18.20%   19.70% 34.80%  
U.S. corporate tax rate     21.00%   35.00%
[1] As of January 1, 2018, the Company adopted the requirements of ASC 606 using the modified retrospective adoption method, and as a result, there is a lack of comparability of certain amounts to the prior periods presented. See Note 2 for additional discussion.
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