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 ~~September~~June 30, ~~2018~~2019

☐ 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.~~CORP.

(Exact Name of Registrant as Specified in Its Charter)

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

35 Wilbur Street Lynbrook, NY 11563

~~(Address~~(Address of Principal Executive Offices) (Zip Code)

516.593.7000

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

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 par value per share	BSTC	The Nasdaq Capital Market

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 every Interactive Data File required to be submitted 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 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 ☐	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~~As of August 9, 2019, there were 7,330,349 shares ~~outstanding~~ of ~~the issuer’s classes of common stock, as of the latest practicable date:~~Common Stock, par value $0.001 per share, outstanding.

~~Class of Stock~~	~~Outstanding November 8, 2018~~
~~Common Stock ($.001 par value)~~	~~7,278,139~~

BIOSPECIFICS TECHNOLOGIES CORP.

TABLE OF CONTENTS

		Page
	PART I – FINANCIAL INFORMATION
ITEM 1.	Financial Statements
	Unaudited Condensed Consolidated Financial Statements	4
	Condensed Consolidated Balance Sheets	4
	Condensed Consolidated Income Statements	5
	Condensed Consolidated Statements of ~~Cash Flows~~Stockholders’ Equity	6
	Condensed Consolidated Statements of Cash Flows	7
	Notes to Condensed Consolidated Financial Statements	78
ITEM 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2018
ITEM 3.	Quantitative and Qualitative Disclosures About Market Risk	2826
ITEM 4.	Controls and Procedures	2927

	PART II – OTHER INFORMATION
ITEM 1.	Legal Proceedings	2927
ITEM 1A.	Risk Factors	2927
ITEM 2.	Unregistered Sales of Equity Securities and Use of Proceeds	3027
ITEM 6.	Exhibits	3129
	Signatures	3230

Table of Contents

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 Quarterly Report on Form 10-Q 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 Quarterly Report on Form 10-Q include statements concerning, among other things, (i) the ~~continued commercialization of XIAFLEX to treat Dupuytren’s contracture~~opportunity for minimally invasive non-surgical treatment XIAFLEX® in several potential pipeline indications; (ii) whether 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; whether Endo will provide us with the interim data necessary for us to calculate our royalty revenue estimate in accordance with our revenue recognition policy; 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; whetherwhen the Company will ~~choose to cancel the lease prior to the expiration of the term; whether and when we will hear~~receive from Endo the results of their ~~ongoing~~full commercial ~~review~~assessment and analysis regarding XIAFLEX® research and development (R&D) pipeline; (iii) the ~~XIAFLEX pipeline;~~Company’s ability to achieve its future growth initiatives with regard to Dupuytren’s Contracture and Peyronie’s disease; (iv) the ~~timing~~expansion of the market for XIAFLEX® through future growth initiatives; (v) whether treating uterine fibroids with XIAFLEX® will achieve the advantages over major surgery identified by the Company; (vi) Endo’s ~~determination~~interest in currently unlicensed indications, including capsular contracture of ~~clinical trial timelines~~the breast, Dercum’s disease, knee arthrofibrosis, urethral strictures, hypertrophic scars and keloids; (vii) whether XIAFLEX® will be the only U.S. Food and Drug Administration (FDA) approved nonsurgical therapy for ~~additional indications;~~frozen shoulder (adhesive capsulitis); (viii) the ~~nature~~projected receipt of ~~our accounts receivable balance.~~ payments from Endo and sublicense income payments based on Endo’s partnerships; and (ix) and the strength of the Company’s IP portfolio.

In some cases, these statements can be identified by forward-looking words such as ~~“believe,~~“expect,” ~~“expect,~~“plan,” “anticipate,” “potential,” “estimate,” ~~“likely,” “may,~~“can,” “will,” ~~“can,” and “could,~~“continue,” 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~~XIAFLEX® in their applicable territories; the market for ~~XIAFLEX~~XIAFLEX® in, and timing, initiation and outcome of clinical trials for, additional indications, ~~that~~which will determine the amount of milestone, royalty, mark-up on cost of goods sold, license and sublicense income that BioSpecifics may receive; the potential of ~~XIAFLEX~~XIAFLEX® to be used in additional indications; Endo modifying its objectives or allocating resources other than to ~~XIAFLEX~~XIAFLEX®; and other risk factors identified in ~~BioSpecifics’,~~the Company’s Annual Report on Form 10-K for the year ended December 31, ~~2017, its~~2018 (2018 Annual Report) and our Quarterly ~~Reports~~Report on Form 10-Q for the quarter ended March 31, ~~2018~~ 2019, specifically in Part I, Item IA under the heading “Risk Factors” and ~~June 30, 2018~~under the section “Management’s Discussion and ~~its Current Reports on Form 8-K filed with the Securities and Exchange Commission.~~ Analysis.” All forward-looking statements included in this Quarterly Report on Form 10-Q for the fiscal period ended June 30, 2019 are made as of the date hereof, are expressly qualified in their entirety by the cautionary statements included in this Quarterly Report on Form 10-Q and, except as may be required by law, we assume no obligation to update these forward-looking statements.

Table of Contents

PART I – FINANCIAL INFORMATION

Item 1:

Condensed Consolidated Financial Statements

BioSpecifics Technologies Corp.

Condensed Consolidated Balance Sheets

	September 30, 2018⁽¹⁾			December 31, 2017			June 30, 2019			December 31, 2018
	(unaudited)			(audited)			(unaudited)			(audited)
Assets
Current assets:
Cash and cash equivalents	$	13,381,013		$	7,333,810		$	13,972,558		$	13,176,452
Short term investments		58,429,211			51,973,971			71,304,188			67,707,143
Accounts receivable		14,455,354			4,655,105			16,729,636			16,518,687
Deferred royalty buy-down		601,660			1,794,126			-			184,931
Prepaid expenses and other current assets		801,956			623,503			1,012,172			646,749
Total current assets		87,669,194			66,380,515			103,018,554			98,233,962

Long-term investments		5,168,322			5,745,974			8,233,138			1,099,834
Deferred royalty buy-down – long term, net		-			732,206
Deferred tax assets, net		275,526			1,739,706			154,309			313,768
Patent costs, net		439,892			397,993			493,856			444,478

Total assets	$	93,552,934		$	74,996,394		$	111,899,857		$	100,092,042

Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses	$	1,116,463		$	933,998		$	710,812		$	1,798,588
Income tax payable		694,050			68,733			878,624			704,934
Deferred revenue		-			1,057,979
Accrued liabilities of discontinued operations		-			78,138
Total current liabilities		1,810,513			2,138,848			1,589,436			2,503,522

Long-term deferred revenue		-			5,340,708

Commitments and Contingencies
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; 7,738,167 and 7,600,167 shares issued, 7,283,528 and 7,189,233 shares outstanding as of September 30, 2018 and December 31, 2017, respectively		7,738			7,600
Common stock, $.001 par value; 10,000,000 shares authorized 7,796,230 and 7,738,167 shares issued, 7,331,917 and 7,275,902 shares outstanding as of June 30, 2019 and December 31, 2018, respectively								7,796			7,738
Additional paid-in capital		36,198,898			33,468,323			38,299,800			36,302,446
Retained earnings		65,993,035			41,939,115			83,019,774			72,176,719
Treasury stock, 454,639 and 410,934 shares at cost as of September 30, 2018 and December 31, 2017, respectively		(10,457,250	)		(7,898,200	)
Treasury stock, 464,313 and 462,265 shares at cost as of June 30, 2019 and December 31, 2018, respectively								(11,016,949	)		(10,898,383	)
Total stockholders’ equity		91,742,421			67,516,838			110,310,421			97,588,520

Total liabilities and stockholders’ equity	$	93,552,934		$	74,996,394		$	111,899,857		$	100,092,042

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 3-~~Summary of Significant Accounting Policies~~ ~~for additional discussion.~~

Table of Contents

BioSpecifics Technologies Corp.

Condensed Consolidated Income Statements

(unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,						Three Months Ended June 30,						Six Months Ended June 30,
	2018⁽¹⁾			2017			2018⁽¹⁾			2017			2019			2018			2019			2018
Revenues:
Royalties	$	8,168,081		$	6,511,700		$	23,068,585		$	20,729,017		$	8,852,986		$	7,815,504		$	16,982,127		$	14,900,504
Licensing revenues		-			4,408			39,679			13,226			-			35,270			-			39,679
Total Revenues		8,168,081			6,516,108			23,108,264			20,742,243			8,852,986			7,850,774			16,982,127			14,940,183

Costs and expenses:
Research and development		162,625			356,847			569,648			949,359			161,321			211,796			310,857			407,023
General and administrative		2,232,077			2,175,501			6,345,662			6,916,501			1,728,125			2,043,952			4,635,284			4,113,585
Total Cost and Expenses		2,394,702			2,532,348			6,915,310			7,865,860			1,889,446			2,255,748			4,946,141			4,520,608

Operating income		5,773,379			3,983,760			16,192,954			12,876,383			6,963,540			5,595,026			12,035,986			10,419,575

Other income:
Interest income		359,637			193,462			851,334			436,210			517,156			273,746			966,580			491,697
Other income		-			14,667			96,663			40,651
Other income (expense)														-			81,985			-			96,663
		359,637			208,129			947,997			476,861			517,156			355,731			966,580			588,360

Income before income tax expense		6,133,016			4,191,889			17,140,951			13,353,244			7,480,696			5,950,757			13,002,566			11,007,935
Provision for income tax expense		(1,089,966	)		(1,477,057	)		(3,271,366	)		(4,669,569	)		(1,054,236	)		(1,102,826	)		(2,159,511	)		(2,181,400	)

Net income	$	5,043,050		$	2,714,832		$	13,869,585		$	8,683,675		$	6,426,460		$	4,847,931		$	10,843,055		$	8,826,535


Basic net income per share	$	0.69		$	0.38		$	1.92		$	1.21		$	0.88		$	0.67		$	1.49		$	1.23
Diluted net income per share	$	0.69		$	0.37		$	1.89		$	1.19		$	0.87		$	0.66		$	1.48		$	1.21

Shares used in computation of basic net income per share		7,281,388			7,164,934			7,230,106			7,166,470			7,308,268			7,215,057			7,292,663			7,204,040
Shares used in computation of diluted net income per share		7,356,885			7,314,609			7,327,029			7,325,602			7,349,696			7,315,276			7,344,008			7,309,325

See accompanying notes to condensed consolidated financial statements.

Table of Contents

BioSpecifics Technologies Corp.

Condensed Consolidated Statements of Stockholders' Equity

	Common Stock
	Shares		Amount		Additional Paid in Capital		Retained Earnings		Treasury Stock			Stockholders’ Equity Total
Balances - December 31, 2018		7,738,167	$	7,738	$	36,302,446	$	72,176,719	$	(10,898,383	)	$	97,588,520
Issuance of common stock upon stock option exercise		58,063		58		1,736,888		-		-			1,736,946
Stock compensation expense		-		-		260,466		-		-			260,466
Repurchases of common stock		-		-		-		-		(118,566	)		(118,566	)
Net income		-		-		-		10,843,055		-			10,843,055
Balances – June 30, 2019		7,796,230	$	7,796	$	38,299,800	$	83,019,774	$	(11,016,949	)	$	110,310,421

	Common Stock
	Shares		Amount		Additional Paid in Capital		Retained Earnings		Treasury Stock			Stockholders’ Equity Total
Balances – March 31, 2019		7,740,167	$	7,740	$	36,502,652	$	76,593,314	$	(10,898,383	)	$	102,205,323
Issuance of common stock upon stock option exercise		56,063		56		1,678,470		-		-			1,678,526
Stock compensation expense		-		-		118,678		-		-			118,678
Repurchases of common stock		-		-		-		-		(118,566	)		(118,566	)
Net income		-		-		-		6,426,460		-			6,426,460
Balances – June 30, 2019		7,796,230	$	7,796	$	38,299,800	$	83,019,774	$	(11,016,949	)	$	110,310,421

	Common Stock
	Shares		Amount		Additional Paid in Capital		Retained Earnings		Treasury Stock			Stockholders’ Equity Total
Balances - December 31, 2017		7,600,167	$	7,600	$	33,468,323	$	41,939,115	$	(7,898,200	)	$	67,516,838
Adjustment due to adoption of ASC606		-		-		-		10,184,335		-			10,184,335
Issuance of common stock upon stock option exercise		55,000		55		859,995		-		-			860,050
Stock compensation expense		-		-		96,314		-		-			96,314
Net income		-		-		-		8,826,535		-			8,826,535
Balances – June 30, 2018		7,655,167	$	7,655	$	34,424,632	$	60,949,985	$	(7,898,200	)	$	87,484,072

	Common Stock
	Shares		Amount		Additional Paid in Capital		Retained Earnings		Treasury Stock			Stockholders’ Equity Total
Balances – March 31, 2018		7,610,167	$	7,610	$	33,633,225	$	56,102,054	$	(7,898,200	)	$	81,844,689
Issuance of common stock upon stock option exercise		45,000		45		727,605		-		-			727,650
Stock compensation expense		-		-		63,802		-		-			63,802
Net income		-		-		-		4,847,931		-			4,847,931
Balances – June 30, 2018		7,655,167	$	7,655	$	34,424,632	$	60,949,985	$	(7,898,200	)	$	87,484,072

See accompanying notes to condensed consolidated financial statements.

Table of Contents

BioSpecifics Technologies Corp.

Condensed Consolidated Statements of Cash Flows

(unaudited)

Nine Months Ended
September 30,

Cash flows from operating activities:
2018⁽¹⁾
2017
Net income $ 13,869,585 $ 8,683,675
Adjustments to reconcile net income to net cash provided by operating activities:

Amortization 1,984,577 1,632,823
Stock-based compensation expense 159,883 100,428
Deferred tax expense 128,418 298,121
Extinguishment of accrued liabilities (78,138 ) -
Changes in operating assets and liabilities:
Accounts receivable (2,245,522 ) (871,093 )
Income tax receivable (774,624 ) 437,781
Prepaid expenses and other current assets (178,453 ) (48,719 )
Patent costs (95,399 ) -
Accounts payable and accrued expenses (356,548 ) 46,626
Deferred revenue (139,680 ) (907,776 )
Net cash provided by operating activities 12,274,099 9,371,866

Cash flows from investing activities:
Maturity of marketable investments 58,380,000 43,579,082
Purchases of marketable investments (64,618,676 ) (50,933,705 )
Net cash used in investing activities (6,238,676 ) (7,354,623 )

Cash flows from financing activities:
Proceeds from stock option exercises 2,570,830 258,250
Payments for repurchase of common stock (2,559,050 ) (616,499 )
Net cash provided by (used in) financing activities 11,780 (358,249 )

Increase in cash and cash equivalents 6,047,203 1,658,994
Cash and cash equivalents at beginning of year 7,333,810 4,763,364
Cash and cash equivalents at end of period $ 13,381,013 $ 6,422,358

Supplemental disclosures of cash flow information:
Cash paid during the period for:
Interest - -
Taxes $ 3,917,572 $ 4,410,000

	Six Months Ended June 30,
Cash flows from operating activities:	2019			2018
Net income	$	10,843,055		$	8,826,535
Adjustments to reconcile net income to net cash provided by operating activities:
Amortization		150,636			1,369,227
Stock-based compensation expense		260,466			96,314
Deferred tax expense		159,459			82,341
Extinguishment of accrued liabilities		-			(78,138	)
Changes in operating assets and liabilities:
Accounts receivable		(210,949	)		(1,438,426	)
Income tax payable		173,690			(518,513	)
Prepaid expenses and other current assets		(365,423	)		(213,476	)
Patent costs		(92,582	)		(79,485	)
Accounts payable and accrued expenses		(1,087,775	)		177,436
Deferred revenue		-			(139,680	)
Net cash provided by operating activities		9,830,577			8,084,135

Cash flows from investing activities:
Maturity of marketable investments		42,451,229			37,279,000
Purchases of marketable investments		(53,104,080	)		(40,596,520	)
Net cash used in investing activities		(10,652,851	)		(3,317,520	)

Cash flows from financing activities:
Proceeds from stock option exercises		1,736,946			860,050
Payments for repurchase of common stock		(118,566	)		-
Net cash provided by financing activities		1,618,380			860,050

Increase in cash and cash equivalents		796,106			5,626,665
Cash and cash equivalents at beginning of year		13,176,452			7,333,810
Cash and cash equivalents at end of period	$	13,972,558		$	12,960,475

Supplemental disclosures of cash flow information:
Cash paid during the period for:
Interest		-			-
Taxes	$	1,826,362		$	2,617,572

See accompanying notes to condensed consolidated financial statements.

Table of Contents

BIOSPECIFICS TECHNOLOGIES CORP.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

~~September~~June 30, ~~2018~~2019

(Unaudited)

1.	~~RESTATEMENT OF PREVIOUSLY REPORTED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS~~

1. ORGANIZATION AND DESCRIPTION OF BUSINESS

In our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 filed with the Securities and Exchange Commission on August 9, 2018, we underestimated the amount of royalty revenue from Endo by approximately $750,000 because we did not have sufficient controls in place and Endo’s sales materially exceeded our estimates based on available historical data for the relevant period. Consequently, we have corrected that amount for the relevant period in this Quarterly Report on Form 10-Q. We have requested that Endo provide this interim data consistently going forward and, they have provided it to us for this quarter ~~ended September 30, 2018. As we continue to refine our estimation process and controls around that process, we will need this data to make reasonable estimates.~~

~~The “As Reported” amounts in the tables below represent the amounts reported in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2018.~~

~~The nature of the restatement adjustments and the impact of the adjustments to June 30, 2018 are shown in the following tables:~~

June 30, 2018
Condensed Consolidated Balance Sheet

As Reported Adjustments Restated
Assets
Accounts Receivable $ 12,893,893 $ 754,365 $ 13,648,258
Total Current Assets 81,402,261 754,365 82,156,626
Total Assets 89,330,315 754,365 90,084,680

Liabilities
AP and Accrued Liabilities 1,591,707 58,740 1,650,447
Income Tax Payable 801,800 148,361 950,161
Total Current Liabilities 2,393,507 207,101 2,600,608

Stockholders' Equity
Retained Earnings 60,402,721 547,264 60,949,985
Total Stockholders' Equity 86,936,808 547,264 87,484,072
Total Liabilities and Stockholders' Equity $ 89,330,315 $ 754,365 $ 90,084,680

Condensed Consolidated Income Statements
Three months ended June 30, 2018 Six months ended June 30, 2018

As
Reported
Adjustments Restated
As
Reported
Adjustments Restated
Revenues
Royalties $ 7,061,139 $ 754,365 $ 7,815,504 $ 14,146,139 $ 754,365 $ 14,900,504
Total Revenues 7,096,409 754,365 7,850,774 14,185,818 754,365 14,940,183

Cost and expenses
General and administrative 1,985,212 58,740 2,043,952 4,054,845 58,740 4,113,585
Total cost and expenses 2,197,008 58,740 2,255,748 4,461,868 58,740 4,520,608

Operating income 4,899,401 695,625 5,595,026 9,723,950 695,625 10,419,575

Income before income tax expense 5,255,132 695,625 5,950,757 10,312,310 695,625 11,007,935
Provision for income tax expense (954,465 ) (148,361 ) (1,102,826 ) (2,033,039 ) (148,361 ) (2,181,400 )
Net income $ 4,300,667 $ 547,264 $ 4,847,931 $ 8,279,271 $ 547,264 $ 8,826,535

Basic net income per share $ 0.60 $ 0.67 $ 1.15 $ 1.23
Diluted net income per share $ 0.59 $ 0.66 $ 1.13 $ 1.21

~~Table of Contents~~

Condensed Consolidated Statement of Cash Flow
Six months ended June 30, 2018

As Reported Adjustments Restated
Cash Flows from Operating Activities
Net Income $ 8,279,271 $ 547,264 $ 8,826,535
Changes in Operating Assets and Liabilities:
Accounts Receivable (684,061 ) (754,365 ) (1,438,426 )
Income tax receivable (666,874 ) 148,361 (518,513 )
Accounts payable and accrued expenses 118,696 58,740 177,436

2.	~~ORGANIZATION AND DESCRIPTION OF BUSINESS~~

We are a biopharmaceutical company involved in the development of an injectable collagenase clostridium histolyticum (CCH) for multiple indications. We maintain intellectual property with respect to injectable CCH that treats, among other indications, Dupuytren’s contracture (DC), Peyronie’s disease (PD), frozen shoulder syndrome, and removal of adipose tissue. Injectable CCH currently ~~have a development~~is approved and marketed in the U.S. under the trademark XIAFLEX^® for the treatment of both DC and PD. XIAFLEX® also is commercialized in Japan, Europe (where it is marketed as Xiapex®), Canada, and Australia for DC, and for PD in Canada, Europe and Australia. We generate revenue primarily from our license agreement with Endo, ~~Global Ventures, a Bermuda unlimited liability company (~~“~~Endo Global Ventures~~”~~), an affiliate~~under which we receive license, sublicense income, royalties, milestones and mark-up on cost of ~~Endo International plc (~~“~~Endo~~”~~), for injectable collagenase for marketed indications~~goods sold payments related to the sale, regulatory submissions and ~~indications in development. Endo assumed this agreement when Endo acquired~~approval of XIAFLEX®.

On August 31, 2011, we entered into the Second Amended and Restated Development and License Agreement (as amended, the “License Agreement”) with Auxilium Pharmaceuticals, Inc. (“~~Auxilium~~”(“Auxilium”) ~~on January 29, 2015 (the~~ “~~Acquisition~~”), an entity that was acquired by Endo in 2015. The License Agreement originally was entered into in June 2004 to obtain exclusive worldwide rights to develop, market, and sell certain products containing our enzyme CCH, which Endo markets for approved indications under the trademark XIAFLEX®. ~~Injectable collagenase clostridium histolyticum is marketed~~Endo’s licensed rights concern the development and commercialization of products, other than dermal formulations labeled for topical administration. Currently, Endo’s licensed rights cover the indications of DC, Dupuytren’s nodules, PD, frozen shoulder, cellulite, canine and human lipomas, plantar fibromatosis, lateral hip fat, and other potential aesthetic indications. We and Endo may further expand the License Agreement to cover other indications as ~~XIAFLEX~~® ~~(or Xiapex~~® ~~in Europe).~~they are developed.

Pursuant to the License Agreement, Endo currently is selling XIAFLEX® in the U.S. for the treatment of DC and PD and is distributing XIAFLEX® in Canada through its operating company, Paladin Labs Inc. Additionally, Endo has entered into several non-affiliated sublicensee agreements (as permitted by the License Agreement), including the following:

An agreement with Swedish Orphan Biovitrum AB (“Sobi”), pursuant to which Sobi has marketing rights for Xiapex® for the treatment of DC and PD in Europe and certain Eurasian countries;

An agreement with Asahi Kasei Pharma Corporation (“Asahi”), pursuant to which Asahi has the right to commercialize XIAFLEX® for the treatment of DC and PD in Japan; and

An agreement with Actelion Pharmaceuticals Ltd. (“Actelion”), pursuant to which Actelion obtained marketing and commercial rights for XIAFLEX® in Australia and New Zealand.

On February 1, 2016, we entered into ~~with Endo~~ the First Amendment (the “~~First Amendment~~”“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.~~Agreement. Pursuant to the First Amendment, wethe Company and Endo Global Ventures 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~~“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. We received this $8.25 million lump sum payment in February 2016 and began recognizing this income over time based on sales by non-affiliated sublicensees of Endo outside of the U.S. according to our revenue recognition policy in the second quarter of 2016.

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. Endo has opted-in to the following indications: frozen shoulder, cellulite, canine lipoma, lateral hip fat, plantar fibromatosis and human lipoma.

Table of Contents

On February 26, 2019, we and Endo entered into the Second Amendment to the License Agreement (the “Second Amendment”) to amend certain provisions of the License Agreement. The Second Amendment has an effective date of January 1, 2019. Pursuant to the terms of the Second Amendment, we have consented to the assignment of the License Agreement by Endo Global Ventures to Endo Global Aesthetics Limited, an Irish private company and an affiliate of Endo Global Ventures that is indirectly wholly-owned by Endo. In addition, the Second Amendment amends certain provisions of the License Agreement to require Endo to provide timely estimates of royalties to assist us in complying with our financial reporting obligations.

The two marketed indications involving our injectable collagenase are ~~Dupuytren~~’~~s contracture~~DC and ~~Peyronie~~’~~s disease. Prior to the Acquisition, Auxilium had, and after the Acquisition,~~PD. 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~~XIAFLEX® for uterine fibroids and initiate the development of ~~XIAFLEX~~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~~presented positive results from two ~~identical~~ Phase 3 ~~RELEASE clinical trials~~studies, RELEASE-1 and RELEASE-2, of ~~XIAFLEX~~CCH for the treatment of cellulite. ~~On November 7, 2018, Endo released positive results from the multicenter, randomized, double-blind, placebo-controlled RELEASE studies, which evaluated the safety and efficacy~~Subjects receiving CCH showed highly statistically significant levels of ~~XIAFLEX~~improvement in ~~reducing~~ the appearance of ~~cellulite.~~ (~~For more~~cellulite with treatment, as measured by the trial's primary endpoint (RELEASE-1, p=0.006 & RELEASE-2, p=0.002), which was at least a ~~more detailed discussion~~2-level composite improvement in cellulite severity at Day 71 as compared to subjects receiving placebo. Statistically significant improvements with CCH versus placebo were observed for 8 of ~~the results see~~ ~~Note~~8 (RELEASE-1) and 7 – ~~Subsequent Events.~~)

~~Table~~ of ~~Contents~~

8 (RELEASE-2) secondary endpoints, in addition to patient-centric endpoints. These data were presented at 2019 American Academy of Dermatology Annual Meeting on March 2, 2019. On May 17, 2019, Endo ~~is currently selling XIAFLEX in the U.S.~~announced that clinical data from a Phase 3 investigational study of CCH for the treatment of ~~Dupuytren~~’~~s contracture~~cellulite was presented at the annual meeting of the American Society for Aesthetic Plastic Surgery. Endo expects to file its Biologics License Application (BLA) with the U.S. Food and ~~Peyronie~~’~~s disease and has an agreement with Swedish Orphan Biovitrum AB (~~“~~Sobi~~”~~), pursuant to which Sobi has marketing rights~~Drug Administration (FDA) for ~~Xiapex for Dupuytren~~’~~s contracture and Peyronie~~’~~s disease in Europe and certain Eurasian countries. Sobi is currently selling Xiapex in Europe and certain Eurasian countries~~CCH for the treatment of ~~Dupuytren~~’~~s contracture and Peyronie~~’~~s disease. In addition, Endo has~~cellulite in the second half of 2019 with an ~~agreement with Asahi Kasei Pharma Corporation (~~“~~Asahi~~”~~) pursuant to which Asahi has~~expected commercial launch in the ~~right to commercialize XIAFLEX~~second half of 2020 upon approval.

We presented data from the Phase 1 clinical trial of CCH for the treatment of ~~Dupuytren~~uterine fibroids at the 66^{’ths contracture} Annual Meeting of the Society of Reproductive Investigation (SRI) on March 14, 2019 in Paris, France. This presentation follows positive top-line results announced in October 2018 demonstrating that CCH significantly reduced collagen content in uterine fibroids. BioSpecifics and ~~Peyronie~~’~~s disease in Japan. Asahi is selling XIAFLEX~~its clinical partners continue to analyze the full Phase 1 data to guide the design of a Phase 2 study of CCH for the treatment of ~~Dupuytren~~’~~s 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.uterine fibroids.

3.	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 ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, as compared to the significant accounting policies disclosed in Note 2 of the Consolidated Financial Statements in the Company’s 2018 Annual ~~Report on Form 10-K for the year ended December 31, 2017.~~Report.

Basis of Presentation

The accompanying condensed consolidated financial statements are unaudited, but include all adjustments (consisting only of normal, recurring adjustments) ~~which~~that 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 ~~SEC~~Securities and Exchange Commission (“SEC”) for quarterly reporting.

The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the risk factors discussed in Part I, Item 1A. Risk Factors in our 2018 Annual Report, ~~on Form 10-K for the year ended December 31, 2017~~ filed with the SEC on ~~March 14, 2018~~April 2, 2019 and in Item 1A of Part 2 of our Quarterly ~~Reports~~Report on Form 10-Q for the quarter end March 31, ~~2018 and June 30, 2018~~2019, filed with the SEC on May 10, ~~2018 and August 9, 2018, respectively.~~2019.

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.

Table of Contents

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 other relevant data including interim data provided by Endo 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”~~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 Accounting Standards Codification (“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).

~~Table of Contents~~

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 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.~~known. 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.

Table of Contents

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 3 – ~~Significant Accounting Policies~~ – ~~Revenue Recognition.~~

In February 2016, FASB issued Accounting Standards Update (“ASU”) No. 2016-02, ~~The adoption~~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 ~~ASC 606 as~~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, ~~January 1, 2018, applying~~a specified asset for the ~~modified-retrospective method, changed~~lease term. Under 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~~new guidance, lessor accounting is largely unchanged. Certain targeted improvements were ~~not recognized until they were fixed and determinable. In addition, deferred revenue associated~~made to align, where necessary, lessor accounting with the ~~prepayment of foreign mark-up on cost of goods sold~~ ~~revenue~~lessee accounting model and ASC 606. 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 r~~ecognized over time based on sales by non-affiliated sublicensees~~provided with a source of ~~Endo outside~~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). 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 ~~U.S. and, under ASC 606,~~ ~~would have been recognized when~~earliest comparative period presented in the ~~transaction occurred in 2016.~~

financial statements. 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:~~

~~Table of Contents~~

~~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 September 30, 2018, contract assets of $8.2 million for which there’s an unconditional right to receive payment were 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)~~:

September 30, 2018
As Reported
Balances Without
Adoption of New
Revenue Standard

Effect of Change
Higher / (Lower)

Assets
Accounts receivable $ 14.5 $ 6.3 $ 8.2
Deferred royalty buy-down 0.6 0.7
(0.1 )
Deferred tax assets 0.3 1.5 (1.2 )
Liabilities
Accounts payable and accrued expenses 1.1 0.5 0.6
Deferred revenue - 1.0 (1.0 )
Income tax payable 0.7 (0.6 )

1.3

Deferred revenue, long term - 4.5 (4.5 )
Equity
Retained earnings 66.0 55.5 10.5

In accordance with the new revenue standard requirements, the impact of adoption on our condensed consolidated statement of operations for the three and nine months ended September 30, 2018 was as follows (in millions):

Three Months Ended September 30, 2018

As Reported

Balances Without
Adoption of New
Revenue Standard

Effect of Change
Higher / (Lower)

Revenues

Royalties

$
8.2

$
8.1

$
0.1

Costs and expenses

General and administrative

$
2.2

$
2.2

$
-

Provision for income taxes

1.1

1.1

-

Net income

5.0

4.9

0.1

~~Table of Contents~~

Nine Months Ended September 30, 2018

As Reported

Balances Without
Adoption of New
Revenue Standard

Effect of Change
Higher / (Lower)

Revenues

Royalties

$
23.1

$
23.1

$
-

Costs and expenses

General and administrative

$
6.3

$
6.3

$
-

Provision for income taxes

3.3

3.5

(0.2
)
Net income

13.9

13.7

0.2

~~In January 2016, the FASB issued new guidance on recognition and measurement of financial assets and financial liabilities. The new guidance will impact the~~approach would not require any transition accounting for ~~equity investments, financial liabilities under~~leases that expired before the ~~fair value option,~~earliest comparative period presented. Lessees 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 forlessors may not apply 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~~full retrospective ~~application to all outstanding instruments, with a cumulative effect adjustment recorded to opening retained earnings.~~transition approach. The adoption of the new standard as of January 1, ~~2018 had no~~2019 did not have a material impact on our consolidated financial statements ~~and related disclosure as we do not currently have any available-for-sale equity investments.~~due to the short term nature of our leases.

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 ASC 606. 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 do not expect the standard will have a material impact on our consolidated financial statements due to the short term nature of our leases.~~

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.

Table of Contents

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, U.S. government agency bonds, municipal bonds and corporate bonds. All investments are classified as held to maturity. As of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, the amortized cost of these investments was ~~$63.6~~$79.5 million and ~~$57.7~~$68.8 million, respectively. No unrealized gains or losses were recorded in either period.

~~Table of Contents~~

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~~duration of those instruments. As of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, there were no recorded unrealized gains or losses on our investments as they are classified as held to maturity. As of ~~September~~June 30, 2019 ~~, 2018~~ and December 31, ~~2017,~~2018, amortized cost basis of the investments approximated their fair value. Interest income for the three and six months ended June 30, 2019 was $0.5 million and $1.0 million, respectively as compared to $0.3 million and $0.5 million in the 2018 periods. At ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, the amortized ~~premium~~net discount / (net premium) included in interest income was ~~$361,000~~approximately $77,000 and ~~$673,000,~~($372,000), respectively. At June 30, 2019 and December 31, 2018, the remaining unamortized net premium / (net discount) was approximately $82,000 and ($121,000), respectively.

The following table presents the Company’s schedule of maturities at ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017:~~2018:

	Maturities as of September 30, 2018				Maturities as of December 31, 2017				Maturities as of June 30, 2019				Maturities as of December 31, 2018
	1 Year or Less		Greater than 1 Year		1 Year or Less		Greater than 1 Year		1 Year or Less		Greater than 1 Year		1 Year or Less		Greater than 1 Year
U.S Government agency									$	1,993,638	$	2,235,124	$	-	$	-
Municipal bonds	$	4,285,175	$	100,000	$	1,002,650	$	100,000		10,821,680	$	-		1,295,350		-
Corporate bonds		49,052,966		4,819,306		48,143,495		3,155,573		53,392,333		5,749,303		61,321,162		1,099,834
Certificates of deposit		5,091,070		249,016		2,827,826		2,490,401		5,096,537		248,711		5,090,631
Total	$	58,429,211	$	5,168,322	$	51,973,971	$	5,745,974	$	71,304,188	$	8,233,138	$	67,707,143	$	1,099,834

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 ~~September~~June 30, ~~2018,~~2019, 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 ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017:~~2018:

September 30, 2018	Type of Instrument	Fair Value		Level 1		Level 2		Level 3

June 30, 2019										Type of Instrument	Fair Value		Level 1		Level 2		Level 3
Cash equivalents	Institutional Money Market	$	9,491,019	$	9,491,019	$	-	$	-	Institutional Money Market	$	1,267,261	$	1,267,261	$	-	$	-

Cash equivalents	Corporate Bonds		1,300,000		1,300,000		-		-

Investments	Municipal Bonds		4,385,175		-		4,385,175		-	U.S. Government Agency		4,228,762		-		4,228,762		-

Investments	Corporate Bonds		53,872,272		-		53,872,272		-	Municipal Bonds		10,821,680		-		10,821,680		-

Investments	Certificates of Deposit		5,340,086		5,340,086		-		-	Corporate Bonds		59,141,636		-		59,141,636		-
Investments										Certificates of Deposit		5,345,248		5,345,248		-		-

December 31, 2017	Type of Instrument	Fair Value		Level 1		Level 2		Level 3

December 31, 2018										Type of Instrument	Fair Value		Level 1		Level 2		Level 3
Cash equivalents	Institutional Money Market	$	3,108,549	$	3,108,549	$	-	$	-	Institutional Money Market	$	6,078,025	$	6,078,025	$	-	$	-

Cash equivalents	Municipal Bonds		800,000		-		800,000		-

Investments	Municipal Bonds		1,102,650		-		1,102,650		-	Municipal Bonds		1,295,350		-		1,295,350		-

Investments	Corporate Bonds		51,299,068		-		51,299,068		-	Corporate Bonds		62,420,996		-		62,420,996		-

Investments	Certificates of Deposit		5,318,227		5,318,227		-		-	Certificates of Deposit		5,090,631		5,090,631		-		-

1412

Table of Contents

Concentration of Credit Risk and Major Customers

The Company maintains investments in FDIC insured certificates of deposits, U.S. government agency bonds, municipal bonds and corporate bonds.

The Company is currently dependent on one customer, Endo, ~~who~~which generates almost all ~~its~~of the Company’s revenues. For the three and ~~nine~~six months ended ~~September~~June 30, 2019, licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately $8.9 million and $17.0 million, respectively and for the three and six months ended June 30, 2018, licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately ~~$8.2~~$7.9 million and $23.1 million, respectively, and for the three and nine months ended September 30, 2017, the licensing, sublicensing, milestones and royalty revenues under the License Agreement with Endo were approximately $6.5 million and $20.7$14.9 million, respectively.

At ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, our accounts receivable balances from Endo were ~~$14.5~~$16.7 million and ~~$4.7~~$16.5 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 ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019 ~~, we~~there were 2,048 shares repurchased ~~43,705 shares~~ at an average price of ~~$58.55 as~~$57.89 compared to no repurchases in the 2018 comparable period.

Stock Repurchase Plan

On May 23, 2019, the Company announced the authorization of a new stock repurchase program under which we can repurchase up to $4 million of our outstanding common stock. Pursuant to the repurchase ~~of 12,048 shares at an average price of $51.17~~program, we plan to repurchase stock through a broker in the ~~corresponding 2017 period.~~open market, provided that the timing, actual number and price per share of the common stock to be purchased will be subject to market conditions, applicable legal requirements, including Rule 10b-18 of the Securities Exchange Act of 1934, as amended, and various other factors.

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 and therefore no allowance is recorded. 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 ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017~~ 2018 our accounts receivable balance was ~~$14.5~~$16.7 million and ~~$4.7~~$16.5 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 3~~- ~~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 September 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 3~~- ~~Summary of Significant Accounting Policies – Recent Accounting Pronouncements~~ - ~~Accounting Pronouncements Adopted.~~)

1513

Table of Contents

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 ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, our net reimbursable third party patent expense was $67,000 and $40,000, respectively, and ~~zero, respectively.~~recorded as a reduction to our accounts receivable balance.

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 ~~nine~~six month periods ended ~~September~~June 30, 2019 and 2018, third-party royalty expenses were $0.2 million and $0.6 million, respectively. For the three and six month periods ended June 30, 2018, third-party royalty expenses were $0.6 million and ~~$1.7~~$1.0 million, respectively. ~~For the three and nine month periods ended September~~As of June 30, ~~2017, third-party royalty expenses were $0.4 million and $1.4 million, respectively. With the adoption of ASC 606 as of January 1, 2018~~ ~~using the modified-retrospective adoption method~~, 2019, we ~~recorded an adjustment to our retained earnings for~~have no further third party royalties ~~expense of $0.5 million associated~~in connection with PD as 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 3~~- ~~Summary of Significant Accounting Policies – Recent Accounting Pronouncements~~ - ~~Accounting Pronouncements Adopted.~~)agreement expired in February 2019.

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.~~PD. 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 January 1, 2018. ~~Royalty~~In March 2019, royalty obligations ~~terminate~~were terminated, which was 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~~XIAFLEX® and ~~Xiapex~~Xiapex® for ~~Peyronie’s disease~~PD on an annual basis as measured by the proportion of the total estimated sales over the five year period. For the three and ~~nine~~six months ended ~~September~~June 30, 2019, we amortized zero and approximately $0.2 million related to this agreement, respectively. For the three and six months ended June 30, 2018 we amortized approximately ~~$0.6~~$0.5 million and ~~$1.6~~$1.0 million, respectively, related to this ~~agreement~~agreement. Royalty buy-down expenses are recorded as part of general and ~~$0.4 million and $1.1 million for the three and nine months ended September 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.administrative expenses. As of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, the remaining capitalized balances were ~~approximately $0.6~~zero and $0.2 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 September 30, 2018, there was no indicator that an impairment existed. (~~For more a more detailed discussion regarding ASC 606 see~~ ~~Note 3~~- ~~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.

1614

Table of Contents

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 and 2019 Omnibus Incentive Compensation Plan

On June 13, 2019, at the Company’s annual meeting, the Company’s stockholders approved the 2019 Omnibus Incentive Compensation Plan (the “2019 Plan”). Upon the 2019 Plan’s approval, approximately 1,248,848 shares of Company common stock were available for issuance thereunder, consisting of 1,100,000 shares authorized for issuance under the 2019 Plan and 148,848 shares then remaining available for issuance under the Company’s 2001 Stock Option Plan (the “2001 Plan”). The ~~Company has~~2019 Plan replaced the 2001 Plan. No new awards will be granted under the 2001 Plan; however, awards outstanding under the 2001 Plan upon approval of the 2019 Plan remain subject to and will be settled under the applicable 2001 Plan.

Grants under the 2019 Plan may consist of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units, other stock-based awards, or cash awards. Employees, key advisors or non-employee directors are eligible to participate in the 2019 Plan. Grants under the 2019 Plan vest over periods ranging from one ~~stock-based compensation plan in effect.~~ to four years and expire ten years from date of grant.

ASC 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 ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, we granted a total of ~~31,500~~10,000 stock options from the 2001 Plan with a weighted average grant date fair value of ~~$18.00~~$66.40 per share.

The assumptions used in the valuation of stock options granted during the ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019 were as follows:

	Nine Months Ended September 30, 2018		Six Months Ended June 30, 2019
Risk-free interest rate	2.62% to 2.81%			2.18	%
Expected term of option	6.25 years			6.25 years
Expected stock price volatility	39.6% to 39.7%			39.5	%
Expected dividend yield	$	0.0	$	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.

Table of Contents

Stock-based compensation expense recognized in general and administrative expenses was approximately ~~$64,000~~$119,000 and ~~$160,000~~$260,000 for the three and ~~nine~~six month periods ended ~~September~~June 30, ~~2018~~2019 and ~~approximately $33,000~~$63,000 and ~~$100,000~~$96,000 for the three and ~~nine months~~six month periods ended ~~September~~June 30, ~~2017,~~2018, respectively.

~~Table of Contents~~

Stock Option Activity

A summary of our stock option activity during the ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019 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 (138,000 ) 18.63 - 3,720,149
Forfeitures or expirations - - - -
Outstanding at September 30, 2018 125,500 $ 29.86 5.16 $ 3,593,430
Exercisable at September 30, 2018 86,500 $ 24.84 3.47 $ 2,910,945

	Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term		Aggregate Intrinsic Value
Outstanding at December 31, 2018		175,500		$	37.73		6.33	$	4,014,235
Grants		10,000			66.40		-		-
Exercised		(58,063	)		29.91		-		1,729,995
Forfeitures		(11,250	)		41.82		-		-
Outstanding at June 30, 2019		116,187		$	43.70		6.89	$	1,926,782
Exercisable at June 30, 2019		92,000		$	23.35		2.84	$	1,593,140

During the ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019 and ~~2017,~~2018, the Company received approximately ~~$2.6~~$1.7 million and ~~$258,000,~~$0.9 million, 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 ~~$58.49~~$59.71 on ~~September 28, 2018,~~June 30, 2019, which would have been received by the option holders had all option holders exercised their options as of that date. We have approximately ~~$548,000~~$1.5 million in unrecognized compensation cost related to stock options outstanding as of ~~September~~June 30, ~~2018,~~2019, which we expect to recognize over the next ~~3.17~~3.38 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 ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, property and equipment were fully depreciated.

Comprehensive Income

For each of the three and ~~nine~~six month periods ended ~~September~~June 30, ~~2018~~2019 and ~~2017,~~2018, 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 ASC 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~~ ~~ASC~~ ~~740-10-45-25,~~ ~~Income Statement Classification~~periods when the differences are expected to reverse. 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 ~~Interest and Penalties, we classify interest associated with income taxes under interest expense and~~the deferred tax ~~penalties under other.~~assets will not be realized.

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 ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, the Company has not recorded any unrecognized tax benefits. We classify interest associated with income taxes under interest expense and tax penalties under other.

Table of Contents

Commitments and Contingencies

On ~~September~~August 14, 2018, the Company entered into an agreement with ~~the Landlord, dated August 14, 2018,~~35 Wilbur Street Associates, LLC (the “Landlord”) to extend the term of the lease to ~~the Headquarters~~our corporate headquarters, which are currently located at 35 Wilbur St., Lynbrook, NY 11563, for an additional one year period (the “Extended Lease Agreement”). The one year extension will end on November 30, 2019. Pursuant to the Extended Lease Agreement, the base rent is $11,500 per month and the Company may cancel the lease with three months’ prior written notice to the Landlord at any time during the term.

18Our rent expense amounted to approximately $34,000 and $67,000 for the three and six months ended June 30, 2019, respectively, and $32,000 and $65,000 for the three and six months in the 2018 periods, respectively.

~~Table of Contents~~

4.	3. NET INCOME PER SHARE

In accordance with ASC 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~~ For the ~~number~~three and six month periods ended June 30, 2019 there were 41,428 and 51,345, respectively, of common equivalent shares attributable to stock options that were included in the calculation of diluted net income per share. There were 63,750 stock options to purchase shares excluded ~~for~~from the calculation of diluted net income per share ~~reported in~~for the ~~condensed consolidated statement of operations.~~three and six month periods ended June 30, 2019, because their effects are anti-dilutive.

Three Months Ended
September 30,

Nine Months Ended
September 30,

2018 2017 2018 2017
Stock options - 20,000 - 20,000

For the three and ~~nine months~~six month periods ended ~~September~~June 30, ~~2017,~~2018 there were 100,219 and 105,285, respectively, of common equivalent shares attributable to stock options that were included in the ~~Company had 20,000~~calculation of diluted net income per share. There were zero stock options ~~which have an exercise price~~to purchase shares excluded from the calculation of ~~$29.21,~~diluted net income per share for the three 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.six month periods ended June 30, 2018, respectively, because their effects are anti-dilutive.

5.	4. ACCOUNTS PAYABLE AND ACCRUED EXPENSES

Accounts payable and accrued expenses consisted of the following:

	September 30, 2018		December 31, 2017		June 30, 2019		December 31, 2018
Trade accounts payable	$	122,485	$	152,542	$	84,617	$	122,199
Accrued legal and other professional fees		200,116		150,691		228,548		308,725
Accrued payroll and related costs		183,435		215,322		105,787		173,123
Third party royalties		589,274		329,211		170,005		1,168,837
Other accruals		21,153		86,232		121,855		25,704
Total	$	1,116,463	$	933,998	$	710,812	$	1,798,588

6.	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. As of June 30, 2019 and December 31, 2018, no impairment existed and no adjustments were warranted.

~~For~~We capitalized approximately $93,000 of patent costs for the ~~nine~~three and six months ended ~~September~~June 30, 2019 as compared to approximately $35,000 and $79,000 for three and six months ended June 30, 2018, ~~we increased our capitalized patent costs based on reports provided to us by Endo.~~respectively. Patent costs may be creditable against future royalty revenues. For each period presented below, net patent costs consisted of:

	September 30, 2018			December 31, 2017			June 30, 2019			December 31, 2018
Patents		1,020,416		$	925,016		$	1,138,797		$	1,046,216
Accumulated amortization		(580,524	)		(527,023	)		(644,941	)		(601,738	)
	$	439,892		$	397,993
Total							$	493,856		$	444,478

1917

Table of Contents

The amortization expense for patents for the three and ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019 was approximately ~~$19,000~~$24,000 and ~~$54,000,~~$43,000, respectively, and for the three and ~~nine~~six months ended ~~September~~June 30, ~~2017~~2018 was approximately ~~$10,000~~$18,000 and ~~$31,000,~~$35,000, respectively. The estimated aggregate amortization expense for the remaining ~~three~~six months of ~~2018~~2019 and each of the years below is approximately as follows:

October 1, 2018 - December 31, 2018	$	19,400
2019		72,700
July 1, 2019 – December 31, 2019			$	43,000
2020		55,800		68,000
2021		38,900		51,000
2022		38,900		51,000
2023				51,000
Thereafter		214,200		230,000
Total			$	494,000

7.	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 nine~~ months ended ~~September~~June 30, 2019 and 2018, the provision for income taxes was $1.1 million and ~~$3.3~~$1.0 million, respectively. As of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, our remaining deferred tax assets were approximately ~~$0.3~~$0.2 million and ~~$1.7~~$0.3 million, respectively.

~~For the three and nine months ended September 30, 2017, the provision for income taxes was $1.5 million and $4.7 million, respectively.~~

The estimated effective tax rate for the three and ~~nine~~six months ended ~~September~~June 30, 2019 was approximately 14% and 17%, respectively, of pre-tax income reported in the period, calculated based on the estimated annual effective rate anticipated for the year ending December 31, 2019 plus the effects, if any, of certain discrete items occurring in 2019.

The estimated effective tax rate for the three and six months ended June 30, 2018 was ~~18.1%~~approximately 18% and ~~19.1%~~20%, 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 nine months ended September 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 nine months ended September 30, 2017 was 35% 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 September 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.

7.	~~SUBSEQUENT EVENTS~~

~~On November 7, 2018, Endo announced positive results from two identical Phase 3~~ R~~andomized~~ EvaL~~uation of C~~E~~llulite Reduction by Coll~~A~~gena~~SE Clostridium Histolyticum (“RELEASE”) studies of CCH for the treatment of cellulite in the buttocks. Subjects receiving CCH showed highly statistically significant levels of improvement in the appearance of cellulite with treatment, as measured by the trial's primary endpoint (RELEASE-1, p=0.006 & RELEASE-2, p=0.002), which was at least a 2-level composite improvement in cellulite severity in the target buttock at Day 71 as compared to subjects receiving placebo. In addition, RELEASE-1 passed 8 out of 8 key secondary endpoints and RELEASE-2 passed 7 out of 8 key secondary endpoints. CCH was well-tolerated in the actively-treated subjects with most adverse events (AEs) being mild to moderate in severity and primarily limited to the local injection area.

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~~ ~~(CCH)~~ CCH for multiple indications. We maintain intellectual property with respect to injectable CCH that treats, among other indications, Dupuytren’s contracture (DC), Peyronie’s disease (PD), frozen shoulder syndrome, and removal of adipose tissue. Injectable CCH currently ~~have a development~~is approved and marketed in the U.S. under the trademark XIAFLEX^® for the treatment of both DC and PD. XIAFLEX® also is commercialized in Japan, Europe (where it is marketed as Xiapex®), Canada, and Australia for DC, and for PD in Canada, Europe and Australia. We generate revenue primarily from our license agreement with Endo, ~~Global Ventures, a Bermuda unlimited liability company (~~“~~Endo Global Ventures~~”~~), an affiliate~~under which we receive license, sublicense income, royalties, milestones and mark-up on cost of ~~Endo International plc (~~“~~Endo~~”~~), for injectable collagenase for marketed indications~~goods sold payments related to the sale, regulatory submissions and ~~indications in development. Endo assumed this agreement when Endo acquired~~approval of XIAFLEX®.

Table of Contents

An agreement with Swedish Orphan Biovitrum AB (“Sobi”), pursuant to which Sobi has marketing rights for Xiapex® for the treatment of DC and PD in Europe and certain Eurasian countries;

An agreement with Asahi Kasei Pharma Corporation (“Asahi”), pursuant to which Asahi has the right to commercialize XIAFLEX® for the treatment of DC and PD in Japan; and

An agreement with Actelion Pharmaceuticals Ltd. (“Actelion”), pursuant to which Actelion obtained marketing and commercial rights for XIAFLEX® in Australia and New Zealand.

~~Table of Contents~~

The two marketed indications involving our injectable collagenase are ~~Dupuytren~~’~~s contracture~~DC and ~~Peyronie~~’~~s disease. Prior to the Acquisition, Auxilium had, and after the Acquisition,~~PD. 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~~XIAFLEX® for uterine fibroids and initiate the development of ~~XIAFLEX~~XIAFLEX® in new potential indications, not licensed by Endo.

patient-centric endpoints. These data were presented at 2019 American Academy of Dermatology Annual Meeting on March 2, 2019. On May 17, 2019, Endo ~~is currently selling XIAFLEX in the U.S.~~announced that clinical data from a Phase 3 investigational study of CCH for the treatment of ~~Dupuytren~~’~~s contracture~~cellulite was presented at the annual meeting of the American Society for Aesthetic Plastic Surgery. Endo expects to file its Biologics License Application (BLA) with the U.S. Food and ~~Peyronie~~’~~s disease and has an agreement with Swedish Orphan Biovitrum AB (~~“~~Sobi~~”~~), pursuant to which Sobi has marketing rights~~Drug Administration (FDA) for ~~Xiapex for Dupuytren~~’~~s contracture and Peyronie~~’~~s disease in Europe and certain Eurasian countries. Sobi is currently selling Xiapex in Europe and certain Eurasian countries~~CCH for the treatment of ~~Dupuytren~~’~~s contracture and Peyronie~~’~~s disease. In addition, Endo has~~cellulite in the second half of 2019 with an ~~agreement with Asahi Kasei Pharma Corporation (~~“~~Asahi~~”~~) pursuant to which Asahi has~~expected commercial launch in the ~~right to commercialize XIAFLEX~~second half of 2020 upon approval.

Table of Contents

We presented data from the Phase 1 clinical trial of CCH for the treatment of ~~Dupuytren~~uterine fibroids at the 66^{’ths contracture} Annual Meeting of the Society of Reproductive Investigation (SRI) on March 14, 2019 in Paris, France. This presentation follows positive top-line results announced in October 2018 demonstrating that CCH significantly reduced collagen content in uterine fibroids. We intend to use the Phase 1 data to inform the development of future clinical studies. BioSpecifics and ~~Peyronie~~’~~s disease in Japan. Asahi is selling XIAFLEX~~its clinical partners continue to analyze the full Phase 1 data to guide the design of a Phase 2 study of CCH for the treatment of ~~Dupuytren~~’~~s 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.uterine fibroids.

Operational Highlights

On ~~October 31, 2018, we announced positive topline data from our Phase~~April 1, ~~trial~~2019, the Company appointed Dr. Ronald Law to the role of Collagenase Clostridium Histolyticum (“CCH”) for the treatment of uterine fibroids. The study met the primary endpoint of safety and tolerability of a single injection of XIAFLEX directly into the uterine fibroids under transvaginal ultrasound guidance with no observed clinically significant adverse reactions. Pharmacodynamic changes were noted in all secondary endpoints, which included assessment of 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 contentPrincipal Executive Officer of the ~~treated fibroids, with~~Company and Mr. Pat Caldwell to the ~~exception~~role of ~~apoptosis.~~Principal Financial Officer, assuming both the principal financial officer and principal accounting officer functions on an interim basis pending an executive search being conducted by the Company.

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~~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~~XIAFLEX® for ~~Dupuytren’s contracture~~DC and ~~Peyronie’s disease,~~PD, successfully develop ~~XIAFLEX~~XIAFLEX® for additional indications, obtain required regulatory approvals, manufacture ~~XIAFLEX~~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.

~~Table of Contents~~

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, U.S. government agency bonds, 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~~Item 1A of Part 1 of our 2018 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 Reports on Form 10Q for the quarter ended March 31, 2018 and June 30, 2018 filed with the SEC on May 10, 2018 and August 9, 2018, respectively.

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, interim data provided by Endo and on various other assumptions that we believe are reasonable under the circumstances. The financial information at ~~September~~June 30, ~~2018~~2019 and for the three and ~~nine~~six months ended ~~September~~June 30, ~~2018~~2019 and ~~2017~~2018 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~~2018 balance sheet amounts and disclosures included herein have been derived from the Company’s December 31, ~~2017~~2018 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~~2018 included in the Company’s 2018 Annual Report ~~on Form 10-Kfiled~~ and with the unaudited condensed consolidated financial statements included in our Quarterly ~~Reports~~Report on Form 10-Q for the first ~~and second quarters~~quarter of ~~2018~~2019 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.

As described in Note 32 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 for the three and ~~nine~~six months ended ~~September~~June 30, ~~2018,~~2019, compared to the critical accounting policies disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our 2018 Annual Report ~~on Form 10-K for the year ended December 31, 2017~~ and ~~our Quarterly Reports on Form 10-Q for the quarter ended March 31, 2018 and June 30, 2018.~~

~~As described in Note 1, in~~ our Quarterly Report on Form 10-Q for the quarter ended ~~June 30, 2018, we underestimated the amount~~March 31, 2019.

Table of ~~royalty revenue from Endo by approximately $750,000 because~~ ~~we did not have sufficient controls in place and~~ Endo’s sales materially exceeded our estimates based on available historical data for the relevant period. Consequently, we have corrected that amount for the relevant period in this Quarterly Report on Form 10-Q. We have requested that Endo provide this interim data consistently going forward and, while they have provided it to us for this quarter ended September 30, 2018, there is no guarantee that they will do so in the future and we may need to make further corrections or adjustments in the future if there are differences between actual and estimated royalties.

Contents

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 ~~nine~~six month periods ended ~~September~~June 30, 2019 and 2018, third-party royalty expenses were $0.2 million and $0.6 million, respectively. For the three and six month periods ended June 30, 2018, third-party royalty expenses were ~~$0.7~~$0.6 million and ~~$1.7~~$1.1 million, respectively. ~~For~~As of June 30, 2019, we have no further third party royalties in connection with PD as the three and nine month periods ended September 30, 2017, third-party royalty expenses were $0.4 million and $1.4 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.agreement expired in February 2019.

Royalty Buy-Down

~~Table of Contents~~

~~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.~~PD. 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 ~~September 30,~~January 1, 2018. ~~Royalty~~In March 2019, royalty obligations ~~terminate~~were terminated, which was 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~~XIAFLEX® and ~~Xiapex~~Xiapex® for ~~Peyronie’s disease~~PD on an annual basis as measured by the proportion of the total estimated sales over the five year period. For the three and ~~nine~~six months ended ~~September~~June 30, ~~2018 and 2017,~~2019, we amortized zero and approximately ~~$0.6 million and $1.6~~$0.2 million related to this agreement, ~~and $0.4 million and $1.1 million for~~respectively. For the three and ~~nine~~six months ended ~~September~~June 30, ~~2017.~~2018 we amortized approximately $0.5 million and $1.0 million, respectively, related to this agreement. Royalty buy-down expenses are recorded as part of general and administrative expenses. As of ~~September~~June 30, ~~2018~~2019 and December 31, ~~2017,~~2018, the remaining capitalized balances were ~~approximately $0.6~~zero and $0.2 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 September 30, 2018, there was no indicator that an impairment existed.

Stock Based Compensation

Under ASC 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 ~~SEPTEMBER~~JUNE 30, ~~2018~~2019 COMPARED TO THREE MONTHS ENDED ~~SEPTEMBER~~JUNE 30, ~~2017~~2018

Revenues

We generate revenue primarily from royalties under the License Agreement and, to a lesser degree, licensing fees, sublicensing fees, and milestones.

Table of Contents

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 ~~September~~June 30, ~~2018~~2019 were ~~$8.2~~$8.9 million as compared to ~~$6.5~~$7.8 million in the corresponding ~~2017~~2018 period, an increase of ~~$1.7~~$1.1 million or ~~26%~~13%. The increase in total revenues for the quarterly period was primarily due to royalties associated with higher net sales of ~~XIAFLEX~~XIAFLEX® in ~~Dupuytren's contracture~~DC and ~~Peyronie’s disease partially offset by lower~~PD, and slightly higher 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.~~revenue.

~~Table of Contents~~

Licensing Revenue

Licensing revenue consists of licensing fees, sublicensing fees and milestones. For the three month ~~periods~~period ended ~~September~~June 30, ~~2018,~~2019, we recognized zero revenue related to nonrefundable upfront product license fees for product candidates as compared to ~~$4,408~~approximately $35,000 in the ~~2017~~2018 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 ~~September~~June 30, ~~2018~~2019 and ~~2017,~~2018, R&D expenses were approximately ~~$0.2 million~~$161,000 and ~~$0.4 million,~~$212,000, 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~~2019 period as compared to the ~~2017~~2018 period was mainly due to ~~lower consulting fees~~reduced cost associated with ~~clinical, clinical costs and~~ other R&D ~~programs.~~

programs and lower clinical costs.

We manage the development of ~~XIAFLEX~~XIAFLEX® for uterine fibroids and initiate the development of ~~XIAFLEX~~XIAFLEX® in new potential indications, not licensed by Endo. ~~On October 31, 2018, we announced positive topline~~We presented data from ~~our~~the Phase 1 clinical trial of CCH for the treatment of uterine fibroids at the 66^th Annual Meeting of the Society of Reproductive Investigation on March 14, 2019 in Paris, France. This presentation follows positive top-line results announced in October 2018 demonstrating that CCH significantly reduced collagen content in uterine fibroids. We intend to use the Phase 1 data to inform the development of future clinical studies. BioSpecifics and its clinical partners continue to analyze the full Phase 1 data to guide the design of a Phase 2 study of CCH for the treatment of uterine fibroids.

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

	Three Months Ended September 30, 2018		Three Months Ended September 30, 2017		Three Months Ended June 30, 2019		Three Months Ended June 30, 2018
Program
Uterine Fibroids	$	82,716	$	129,276	$	66,127	$	104,596
Pre-clinical/other research projects		79,909		227,571		95,194		107,200
Total R&D expenses					$	161,321	$	211,796

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~~XIAFLEX® and ~~Xiapex,~~Xiapex®, to continue to commercialize these drug candidates.

Table of Contents

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 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 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 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;~~

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;~~

clinical trial results for our drug candidate projects;

~~Table of Contents~~

~~the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights relating to 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 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 and timing of regulatory approvals with respect to our drug candidate projects; and

the cost of establishing clinical supplies for our drug candidate projects.

~~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 ~~September~~June 30, 2019 and 2018 were $1.7 million and ~~2017 were $2.2~~$2.0 million, ~~in each period. Changes~~respectively. The decrease in general and administrative expenses was mainly due to lower third party royalties associated with XIAFLEX® and the ~~higher~~ amortization associated with deferred royalty buy-down ~~third party royalties associated with XIAFLEX, patent fees and professional fees~~related to PD, partially offset by ~~lower consulting~~legal fees, personnel expenses and ~~general legal fees.~~stock compensation expense.

Other Income

Other income for the three months ended ~~September~~June 30, ~~2018~~2019 was approximately ~~$360,000~~$517,000 compared to ~~$208,000~~$356,000 in the corresponding ~~2017~~2018 period. Other income consists of interest earned on our investments and, in the 2018 period, limited 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 ~~September~~June 30, 2019, our provision for income taxes was $1.1 million. Our deferred tax assets as of June 30, 2019 were $0.2 million. The estimated effective tax rate for the three months ended June 30, 2019 was approximately 14% of pre-tax income reported in the period, calculated based on the estimated annual effective tax rate anticipated for the year ending December 31, 2019 plus the effects of certain discrete items occurring in 2019 including the impact of U.S. Treasury guidance issued in 2019 on the application of certain provisions in the Tax Cuts and Jobs Act of 2017 (“TCJA”) allowing the Company to refine its calculations and current period stock option exercises.

For the three month period ended June 30, 2018, our provision for income taxes was $1.1 million. Our deferred tax assets as of ~~September~~June 30, 2018 were $0.3 million. The estimated effective tax rate for the three months ended ~~September~~June 30, 2018 was ~~18.1%~~approximately 18% 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 ~~September~~June 30, 2018 was impacted primarily by the ~~Tax Cuts and Jobs Act of 2017,~~TCJA, 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 September 30, 2017, our provision for income taxes was $1.5 million. Our deferred tax assets as~~

Table of September 30, 2017 were $3.0 million. The effective tax rate for the three months ended September 30, 2017 was 35% 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.Contents

Net Income

For the three months ended ~~September~~June 30, ~~2018,~~2019, we recorded net income of ~~$5.0~~$6.4 million, or ~~$0.69~~$0.88 per basic common share and ~~$0.69~~ per diluted common share, compared to a net income of ~~$2.7~~$4.8 million, or ~~$0.38~~$0.67 per basic common share and ~~$0.37~~$0.66 per diluted common share, for the same period in ~~2017.~~2018.

~~NINE~~SIX MONTHS ENDED ~~SEPTEMBER~~JUNE 30, ~~2018~~2019 COMPARED TO ~~NINE~~SIX MONTHS ENDED ~~SEPTEMBER~~JUNE 30, ~~2017~~2018

Revenues

25We generate revenue primarily from royalties under the License Agreement and, to a lesser degree, licensing fees, sublicensing fees, and milestones.

~~Table of Contents~~

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 ~~nine~~six month period ended ~~September~~June 30, ~~2018~~2019 were ~~$23.1~~$17.0 million as compared to ~~$20.7~~$14.9 million in the corresponding ~~2017~~2018 period, an increase of ~~$2.4~~$2.1 million, or ~~12%~~14%. The increase in total revenues for the ~~nine month~~quarterly period was primarily due to royalties associated with higher net sales of ~~XIAFLEX~~XIAFLEX® in ~~Dupuytren’s contracture~~DC and ~~Peyronie’s disease partially offset by lower~~PD, and higher 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.~~

revenue.

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 ~~nine~~six month periods ended ~~September~~June 30, ~~2018,~~2019, we recognized ~~the remaining $39,679~~zero revenue related to nonrefundable upfront product license fees for product candidates as ~~there were no remaining~~ ~~performance obligations~~ as compared to ~~$13,226~~approximately $40,000 in the ~~2017~~2018 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 ~~nine~~six month periods ended ~~September~~June 30, ~~2018~~2019 and ~~2017,~~2018, R&D expenses were approximately ~~$0.6~~$0.3 million and ~~$0.9~~$0.4 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~~2019 period as compared to the ~~2017~~2018 period was mainly due to ~~lower consulting fees~~reduced cost associated with ~~clinical, clinical costs and~~ other R&D ~~programs.~~

programs and lower clinical costs.

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

	Nine Months Ended September 30, 2018		Nine Months Ended September 30, 2017		Six Months Ended June 30, 2019		Six Months Ended June 30, 2018
Program
Uterine Fibroids	$	210,250	$	357,409	$	126,412	$	127,534
Pre-clinical/other research projects		359,398		591,950		184,445		279,489
Total R&D expenses					$	310,857	$	407,023