0001023024-21-000021 | 10-Q | XBRL Viewer

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Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2021	Oct. 25, 2021
Document Information [Line Items]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2021
Document Transition Report	false
Entity File Number	001-31812
Entity Registrant Name	ANI PHARMACEUTICALS, INC
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	58-2301143
Entity Address, Address Line One	210 Main Street West
Entity Address, City or Town	Baudette
Entity Address, State or Province	MN
Entity Address, Postal Zip Code	56623
City Area Code	218
Local Phone Number	634-3500
Title of 12(b) Security	Common Stock
Trading Symbol	ANIP
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Central Index Key	0001023024
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q3
Amendment Flag	false
Common Stock [Member]
Document Information [Line Items]
Entity Common Stock, Shares Outstanding		12,740,853
Class C Special Stock [Member]
Document Information [Line Items]
Entity Common Stock, Shares Outstanding		10,864

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Current Assets
Cash and cash equivalents	$ 15,254	$ 7,864
Accounts receivable, net of $108,456 and $100,328 of adjustments for chargebacks and other allowances at September 30, 2021 and December 31, 2020, respectively	106,714	95,793
Inventories, net	61,684	60,803
Prepaid income taxes	3,030
Prepaid expenses and other current assets	4,702	5,861
Total Current Assets	191,384	170,321
Property and equipment	60,816	58,797
Accumulated depreciation	(21,290)	(17,528)
Property and equipment, net	39,526	41,269
Restricted cash	5,001	5,003
Deferred tax assets, net of deferred tax liabilities and valuation allowance	60,196	51,704
Intangible assets, net	170,141	188,511
Goodwill	3,580	3,580
Other non-current assets	626	802
Total Assets	470,454	461,190
Current Liabilities
Current debt, net of deferred financing costs	15,927	13,243
Accounts payable	11,513	11,261
Accrued royalties	3,996	6,407
Accrued compensation and related expenses	4,539	6,231
Current income taxes payable, net		3,906
Accrued government rebates	11,713	7,826
Returned goods reserve	32,229	27,155
Deferred revenue	62	80
Accrued expenses and other	4,893	2,456
Total Current Liabilities	84,872	78,565
Non-current Liabilities
Non-current debt, net of deferred financing costs and current component	186,063	172,443
Derivatives and other non-current liabilities	8,116	14,482
Total Liabilities	279,051	265,490
Commitments and Contingencies (Note 11)
Stockholders' Equity
Common Stock, $0.0001 par value, 33,333,334 shares authorized; 12,823,515 shares issued and 12,740,853 outstanding at September 30, 2021; 12,429,916 shares issued and 12,354,398 shares outstanding at December 31, 2020	1	1
Class C Special Stock, $0.0001 par value, 781,281 shares authorized; 10,864 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively
Preferred Stock, $0.0001 par value, 1,666,667 shares authorized; 0 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively
Treasury stock, 82,662 shares of common stock, at cost, at September 30, 2021 and 75,518 shares of common stock, at cost, at December 31, 2020	(3,135)	(2,246)
Additional paid-in capital	222,211	214,354
Accumulated deficit	(23,439)	(4,972)
Accumulated other comprehensive loss, net of tax	(4,235)	(11,437)
Total Stockholders' Equity	191,403	195,700
Total Liabilities and Stockholders' Equity	$ 470,454	$ 461,190

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Adjustments for chargebacks and other allowances	$ 108,456	$ 100,328
Preferred Stock, Par or Stated Value Per Share (in dollars per share)	$ 0.0001	$ 0.0001
Preferred Stock, Shares Authorized	1,666,667	1,666,667
Preferred Stock, Shares Issued	0	0
Preferred Stock, Shares Outstanding	0	0
Treasury Stock, Common, Shares	82,662	75,518
Common Stock [Member]
Common Stock, Par Value (in dollars per share)	$ 0.0001	$ 0.0001
Common Stock, Authorized Shares	33,333,334	33,333,334
Common Stock, Issued Shares	12,823,515	12,429,916
Common Stock, Outstanding Shares	12,740,853	12,354,398
Class C Special Stock [Member]
Common Stock, Par Value (in dollars per share)	$ 0.0001	$ 0.0001
Common Stock, Authorized Shares	781,281	781,281
Common Stock, Issued Shares	10,864	10,864
Common Stock, Outstanding Shares	10,864	10,864

Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Condensed Consolidated Statements of Operations
Net Revenues	$ 52,061	$ 52,979	$ 155,207	$ 151,223
Operating Expenses
Cost of sales (excluding depreciation and amortization)	24,413	20,118	66,712	62,617
Research and development	2,456	2,939	8,229	12,318
Selling, general, and administrative	17,181	15,725	53,588	50,621
Depreciation and amortization	11,346	11,358	33,568	33,739
Legal settlement expense			8,400	0
Purified Cortrophin Gel pre-launch charges	227	37	780	8,275
Total Operating Expenses	55,623	50,177	171,277	167,570
Operating (Loss)/Income	(3,562)	2,802	(16,070)	(16,347)
Other Expense, net
Interest expense, net	(2,497)	(2,510)	(7,482)	(6,898)
Other expense, net	(1,071)	(229)	(1,653)	(335)
(Loss)/Income Before Benefit for Income Taxes	(7,130)	63	(25,205)	(23,580)
Benefit for income taxes	2,683	371	6,738	4,667
Net (Loss)/Income	$ (4,447)	$ 434	$ (18,467)	$ (18,913)
Basic and Diluted (Loss)/Earnings Per Share:
Basic (Loss)/Earnings Per Share	$ (0.37)	$ 0.04	$ (1.53)	$ (1.58)
Diluted (Loss)/Earnings Per Share	$ (0.37)	$ 0.04	$ (1.53)	$ (1.58)
Basic Weighted-Average Shares Outstanding	12,107	11,991	12,066	11,953
Diluted Weighted-Average Shares Outstanding	12,107	12,003	12,066	11,953

Condensed Consolidated Statements of Comprehensive Income/(Loss) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Condensed Consolidated Statements of Comprehensive (Loss)/Income
Net (loss)/income	$ (4,447)	$ 434	$ (18,467)	$ (18,913)
Other comprehensive income/(loss), net of tax:
Gains/(losses) on interest rate swap, net of tax	1,198	939	7,202	(8,239)
Total other comprehensive income/(loss), net of tax	1,198	939	7,202	(8,239)
Total comprehensive (loss)/income, net of tax	$ (3,249)	$ 1,373	$ (11,265)	$ (27,152)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

- Definition

Amount after tax and reclassification adjustments of other comprehensive income (loss).

+ References

+ Details

Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands	Common Stock [Member]	Additional Paid-in Capital [Member]	Treasury Stock [Member]	Accumulated Other Comprehensive Gain/(Loss), Net of Tax [Member]	Retained Earnings/(Accumulated Deficit) [Member] Cumulative Effect, Period of Adoption, Adjustment [Member]	Retained Earnings/(Accumulated Deficit) [Member]	Cumulative Effect, Period of Adoption, Adjustment [Member]	Total
Balance at Dec. 31, 2019	$ 1	$ 200,800	$ (723)	$ (4,871)	$ (8)	$ 17,584	$ (8)	$ 212,791
Balance (in shares) at Dec. 31, 2019	12,105		15
Stock-based Compensation Expense		10,543						10,543
Treasury Stock Purchases for Restricted Stock Vests			$ (1,523)					(1,523)
Treasury Stock Purchases for Restricted Stock Vests (in shares)			61
Issuance of Common Shares upon Stock Option and ESPP Exercise		449						449
Issuance of Common Shares upon Stock Option and ESPP Exercise (in shares)	14
Issuance of Restricted Stock Awards (in shares)	304
Gains/(losses) on interest rate swap, net of tax				(8,239)				(8,239)
Net (loss)/income						(18,913)		(18,913)
Balance at Sep. 30, 2020	$ 1	211,792	$ (2,246)	(13,110)		(1,337)		195,100
Balance (in shares) at Sep. 30, 2020	12,423		76
Balance at Jun. 30, 2020	$ 1	209,409	$ (2,246)	(14,049)		(1,771)		191,344
Balance (in shares) at Jun. 30, 2020	12,380		58
Stock-based Compensation Expense		2,383						2,383
Treasury Stock Purchases for Restricted Stock Vests (in shares)			18
Issuance of Restricted Stock Awards (in shares)	43
Gains/(losses) on interest rate swap, net of tax				939				939
Net (loss)/income						434		434
Balance at Sep. 30, 2020	$ 1	211,792	$ (2,246)	(13,110)		(1,337)		195,100
Balance (in shares) at Sep. 30, 2020	12,423		76
Balance at Dec. 31, 2020	$ 1	214,354	$ (2,246)	(11,437)		(4,972)		195,700
Balance (in shares) at Dec. 31, 2020	12,430		76
Stock-based Compensation Expense		7,521						7,521
Treasury Stock Purchases for Restricted Stock Vests			$ (889)					(889)
Treasury Stock Purchases for Restricted Stock Vests (in shares)			28
Issuance of Common Shares upon Stock Option and ESPP Exercise		336						336
Issuance of Common Shares upon Stock Option and ESPP Exercise (in shares)	12
Issuance of Restricted Stock Awards (in shares)	463
Restricted Stock Awards Forfeitures (in shares)	(81)		(21)
Gains/(losses) on interest rate swap, net of tax				7,202				7,202
Net (loss)/income						(18,467)		(18,467)
Balance at Sep. 30, 2021	$ 1	222,211	$ (3,135)	(4,235)		(23,439)		191,403
Balance (in shares) at Sep. 30, 2021	12,824		83
Balance at Jun. 30, 2021	$ 1	219,403	$ (3,062)	(5,433)		(18,992)		191,917
Balance (in shares) at Jun. 30, 2021	12,826		80
Stock-based Compensation Expense		2,808						2,808
Treasury Stock Purchases for Restricted Stock Vests			$ (73)					(73)
Treasury Stock Purchases for Restricted Stock Vests (in shares)			3
Issuance of Restricted Stock Awards (in shares)	6
Restricted Stock Awards Forfeitures (in shares)	(8)
Gains/(losses) on interest rate swap, net of tax				1,198				1,198
Net (loss)/income						(4,447)		(4,447)
Balance at Sep. 30, 2021	$ 1	$ 222,211	$ (3,135)	$ (4,235)		$ (23,439)		$ 191,403
Balance (in shares) at Sep. 30, 2021	12,824		83

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Cash Flows From Operating Activities
Net Loss	$ (18,467)	$ (18,913)
Adjustments to reconcile net loss to net cash and cash equivalents provided by operating activities:
Stock-based compensation	7,521	10,543
Deferred taxes	(8,665)	(9,032)
Depreciation and amortization	33,568	33,739
Acquired in-process research and development ("IPR&D")	0	3,753
Non-cash interest	1,718	1,288
Asset impairment charge	0	104
Changes in operating assets and liabilities, net of acquisitions:
Accounts receivable, net	(10,921)	(11,616)
Inventories, net	8,773	(1,151)
Prepaid expenses and other current assets	1,421	637
Accounts payable	396	(146)
Accrued royalties	(2,411)	1,004
Current income taxes payable, net	(6,936)	(545)
Accrued government rebates	3,887	2,777
Returned goods reserve	5,091	6,456
Accrued expenses, accrued compensation, and other	532	2,078
Net Cash and Cash Equivalents Provided by Operating Activities	15,507	20,976
Cash Flows From Investing Activities
Acquisition of product rights, IPR&D, and other related assets	(21,069)	(62,178)
Acquisition of property and equipment, net	(2,201)	(4,025)
Net Cash and Cash Equivalents Used in Investing Activities	(23,270)	(66,203)
Cash Flows From Financing Activities
Payments on Term Loan and Delayed Draw Term Loan agreements	(8,034)	(5,657)
Borrowings under Revolver agreement	24,000	15,000
Payments on Revolver agreement	0	(7,500)
Proceeds from stock option exercises and ESPP purchases	336	449
Payments of debt issuance costs	(262)	0
Treasury stock purchases for restricted stock vests	(889)	(1,523)
Net Cash and Cash Equivalents Provided by Financing Activities	15,151	769
Net Change in Cash and Cash Equivalents	7,388	(44,458)
Cash and cash equivalents, and restricted cash, beginning of period	12,867	67,361
Cash and cash equivalents, and restricted cash, end of period	20,255	22,903
Reconciliation of cash, cash equivalents, and restricted cash, beginning of period
Cash and cash equivalents	7,864	62,332
Restricted cash	5,003	5,029
Cash and cash equivalents, and restricted cash, beginning of period	12,867	67,361
Reconciliation of cash, cash equivalents, and restricted cash, end of period
Cash and cash equivalents	15,254	17,900
Restricted cash	5,001	5,003
Cash and cash equivalents, and restricted cash, end of period	20,255	22,903
Supplemental disclosure for cash flow information:
Cash paid for interest, net of amounts capitalized	5,922	5,080
Cash paid for income taxes	8,360	4,878
Supplemental non-cash investing and financing activities:
Acquisition of product rights, IPR&D, and other related assets included in returned goods reserve and derivatives and other non-current liabilities	0	399
Property and equipment purchased and included in accounts payable	$ 28	$ 223

BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS

9 Months Ended

Sep. 30, 2021

BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS

BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS

1.	BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS

Overview

ANI Pharmaceuticals, Inc. and its consolidated subsidiaries, ANIP Acquisition Company and ANI Pharmaceuticals Canada Inc. (together, “ANI,” the “Company,” “we,” “us,” or “our”), is an integrated specialty pharmaceutical company focused on delivering value to our customers by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals, including for diseases with high unmet medical need. We focus on niche and high barrier to entry opportunities, including controlled substances, oncology products (anti-cancer), hormones and steroids, and complex formulations. Our three pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota and one is located in Oakville, Ontario, are together capable of producing oral solid dose products, as well as semi-solids, liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment.

Basis of Presentation

The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). In our opinion, the accompanying unaudited interim condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations, comprehensive income, and cash flows. The consolidated balance sheet at December 31, 2020 has been derived from audited financial statements as of that date. The unaudited interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the U.S. Securities and Exchange Commission (the “SEC”). We believe that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim condensed consolidated financial statements are read in conjunction with the audited financial statements and notes previously distributed in our Annual Report on Form 10-K for the year ended December 31, 2020.

Principles of Consolidation

The unaudited interim condensed consolidated financial statements include the accounts of ANI Pharmaceuticals, Inc. and its subsidiaries. All intercompany accounts and transactions are eliminated in consolidation.

Foreign Currency

We have a subsidiary located in Canada. The subsidiary conducts its transactions in U.S. dollars and Canadian dollars, but its functional currency is the U.S. dollar. The results of any non-U.S. dollar transactions are remeasured in U.S. dollars at the applicable exchange rates during the period and resulting foreign currency transaction gains and losses are included in the determination of net income. Our gain or loss on transactions denominated in foreign currencies was immaterial for the three and nine months ended September 30, 2021 and 2020. Unless otherwise noted, all references to “$” or “dollar” refer to the U.S. dollar.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires us 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 financial statements and the reported amount of revenues and expenses during the reporting period. In the accompanying unaudited interim condensed consolidated financial statements, estimates are

used for, but not limited to, stock-based compensation, revenue recognition, allowance for credit losses, variable consideration determined based on accruals for chargebacks, administrative fees and rebates, government rebates, returns and other allowances, allowance for inventory obsolescence, valuation of financial instruments and intangible assets, accruals for contingent liabilities, fair value of long-lived assets, income tax provision or benefit, deferred taxes and valuation allowance, determination of right-of-use assets and lease liabilities, purchase price allocations, and the depreciable lives of long-lived assets. Because of the uncertainties inherent in such estimates, actual results may differ from those estimates. Management periodically evaluates estimates used in the preparation of the financial statements for reasonableness.

We are subject to risks and uncertainties as a result of the novel coronavirus (“COVID-19”) pandemic. We are unable to predict the impact that the COVID-19 pandemic will continue to have on our future business, financial condition, and results of operations due to numerous uncertainties. These uncertainties include the occurrence of recurring outbreaks and their severity and the duration of the pandemic, the actions taken to contain the pandemic or mitigate its impact and the direct and indirect economic effects of the pandemic and containment measures, among others. We remain unable to predict the future impact on our estimates and assumptions. There was no material impact to these estimates or assumptions in our consolidated financial statements as of and for the three and nine months ended September 30, 2021 and 2020. Actual results could differ from those estimates, which may change our estimates in future periods. We continue to closely monitor the impact of the COVID-19 pandemic on our business.

Geographic Information

Based on the distinct nature of our operations, our internal management structure, and the financial information that is evaluated regularly by our Chief Operating Decision Maker, we determined that we operate in one reportable segment. Our operations are located in the United States and Canada. The majority of the assets of the Company are located in the United States.

The following table depicts the Company’s revenue by geographic operations during the following periods:


(in thousands)	Three Months Ended September 30,				Nine Months Ended September 30,
Location of Operations	2021		2020		2021		2020
United States	$	51,100	$	52,094	$	152,007	$	146,602
Canada		961		885		3,200		4,621
Total Revenue	$	52,061	$	52,979	$	155,207	$	151,223

The following table depicts the Company’s property and equipment, net according to geographic location as of:


(in thousands)	September 30, 2021		December 31, 2020
United States	$	25,512	$	26,960
Canada		14,014		14,309
Total property and equipment, net	$	39,526	$	41,269

Recent Accounting Pronouncements

Recent Accounting Pronouncements Not Yet Adopted

We have evaluated all issued and unadopted Accounting Standards Updates and believe the adoption of these standards will not have a material impact on our condensed consolidated statements of operations, comprehensive income, balance sheets, or cash flows.

Recently Adopted Accounting Pronouncements

In August 2020, the Financial Accounting Standards Board (“FASB”) issued guidance simplifying the accounting for certain financial instruments with characteristics of liabilities and equity, including certain convertible instruments and contracts on an entity’s own equity. The new standard removes the separation models required for convertible debt with cash conversion features and convertible instruments with beneficial conversion features. It also removes certain settlement conditions that are currently required for equity contracts to qualify for the derivative scope exception and simplifies the diluted earnings per share calculation for convertible instruments. We early adopted this guidance as of January 1, 2021. The adoption of this guidance did not have a material impact on our consolidated financial statements but will impact how we account for newly issued convertible instruments in future periods.

In November 2019, the FASB issued guidance simplifying the accounting for income taxes by removing the following exceptions: 1) exception to the incremental approach for intraperiod tax allocation when there is a loss from continuing operations and income or a gain from other items, 2) exception requirement to recognize a deferred tax liability for equity method investments when a foreign subsidiary becomes an equity method investment, 3) exception to the ability not to recognize a deferred tax liability for a foreign subsidiary when a foreign equity method investment becomes a subsidiary, and 4) exception to the general methodology for calculating income taxes in an interim period when a year-to-date loss exceeds the anticipated loss for the year. The amendments also simplify accounting for income taxes by doing the following: 1) requiring that an entity recognize a franchise tax or similar tax that is partially based on income as an income-based tax and account for any incremental amount incurred as a non-income-based tax, 2) requiring that an entity evaluate when a step up in the tax basis of goodwill should be considered part of the business combination in which the book goodwill was originally recognized and when it should be considered a separate transaction, 3) specifying that an entity is not required to allocate the consolidated amount of current and deferred tax expense to a legal entity that is not subject to tax in its separate financial statements, 4) requiring that an entity reflect the effect of an enacted change in tax laws or rates in the annual effective tax rate computation in the interim period that includes the enactment date, and 5) making minor Codification improvements for income taxes related to employee stock ownership plans and investments in qualified affordable housing projects accounted for using the equity method. Most of the provisions of this guidance were to be adopted on a prospective basis. Items 2) and 3) of the “removal” provisions were to be adopted on either a full or modified retrospective basis and item 4) of the “simplifying” provisions was to be adopted on a full retrospective basis. The guidance was effective for reporting periods beginning after December 15, 2020, including interim periods within that fiscal year. We adopted this guidance as of January 1, 2021. The adoption of this guidance did not have a material impact on our consolidated financial statements.

REVENUE RECOGNITION AND RELATED ALLOWANCES

9 Months Ended

Sep. 30, 2021

REVENUE RECOGNITION AND RELATED ALLOWANCES

REVENUE RECOGNITION AND RELATED ALLOWANCES

2.	REVENUE RECOGNITION AND RELATED ALLOWANCES

Revenue Recognition

We recognize revenue using the following steps:

●

Identification of the contract, or contracts, with a customer;

●

Identification of the performance obligations in the contract;

●

Determination of the transaction price, including the identification and estimation of variable consideration;

●

Allocation of the transaction price to the performance obligations in the contract; and

●

Recognition of revenue when we satisfy a performance obligation.

We derive our revenues primarily from sales of generic and branded pharmaceutical products. Revenue is recognized when our obligations under the terms of our contracts with customers are satisfied, which generally occurs when control of the products we sell is transferred to the customer. We estimate variable consideration after considering applicable information that is reasonably available. We generally do not have incremental costs to

obtain contracts that would otherwise not have been incurred. We do not adjust revenue for the promised amount of consideration for the effects of a significant financing component because our customers generally pay us within 100 days.

All revenue recognized in the accompanying unaudited interim condensed consolidated statements of operations is considered to be revenue from contracts with customers. The following table depicts the disaggregation of revenue:


	Three Months Ended				Nine Months Ended
Products and Services	September 30,		September 30,		September 30,		September 30,
(in thousands)	2021		2020		2021		2020
Sales of generic pharmaceutical products	$	35,140	$	37,712	$	101,952	$	108,607
Sales of branded pharmaceutical products		14,313		12,411		32,868		32,201
Sales of contract manufactured products		2,382		2,152		7,277		7,026
Royalties from licensing agreements		—		339		11,210		1,120
Product development services		77		289		332		1,751
Other		149		76		1,568		518
Total net revenues	$	52,061	$	52,979	$	155,207	$	151,223


	Three Months Ended				Nine Months Ended
Timing of Revenue Recognition	September 30,		September 30,		September 30,		September 30,
(in thousands)	2021		2020		2021		2020
Performance obligations transferred at a point in time	$	51,984	$	52,690	$	154,875	$	149,472
Performance obligations transferred over time		77		289		332		1,751
Total	$	52,061	$	52,979	$	155,207	$	151,223

In the three and nine months ended September 30, 2021 and 2020, we did not incur, and therefore did not defer, any material incremental costs to fulfill contracts. We recognized an increase of $11.0 million to net revenue from performance obligations satisfied in prior periods during the nine months ended September 30, 2021, consisting primarily of a final $11.2 million royalty revenue related to the Kite license agreement pursuant to the Tripartite Agreement as defined and described herein in Royalties from Licensing Agreements, which was partially offset by a decrease related to revised estimates for variable consideration, including chargebacks, rebates, returns, and other allowances, related to prior period sales. We recognized a decrease of $8.7 million of net revenue from performance obligations satisfied in prior periods during the nine months ended September 30, 2020, consisting primarily of revised estimates for variable consideration, including chargebacks, rebates, returns, and other allowances, related to prior period sales. We provide technical transfer services to customers, for which services are transferred over time. As of September 30, 2021 and December 31, 2020, we did not have any contract assets related to revenue recognized based on percentage of completion but not yet billed. We had $0.1 million of deferred revenue at September 30, 2021 and December 31, 2020. For the three and nine months ended September 30, 2021, we recognized less than $0.1 million of revenue that was included in deferred revenue as of December 31, 2020. For the three and nine months ended September 30, 2020, we recognized $0.1 million and $0.3 million, respectively, of revenue that was included in deferred revenue as of December 31, 2019.

Revenue from Sales of Generic and Branded Pharmaceutical Products

Product sales consists of sales of our generic and brand pharmaceutical products. Our sole performance obligation in our contracts is to provide pharmaceutical products to customers. Our products are sold at pre-determined

standalone selling prices and our performance obligation is considered to be satisfied when control of the product is transferred to the customer. Control is generally transferred to the customer upon delivery of the product to the customer, as our pharmaceutical products are generally sold on an FOB destination basis and because inventory risk and risk of ownership passes to the customer upon delivery. Payment terms for these sales are generally less than 100 days.

Sales of our pharmaceutical products are subject to variable consideration due to chargebacks, government rebates, returns, administrative and other rebates, and cash discounts. Estimates for these elements of variable consideration require significant judgment. A comprehensive discussion of variable consideration is included in Part II, Item 8. Consolidated Financial Statements, Note 1, Description of Business and Summary of Significant Accounting Policies, in our Annual Report on Form 10-K for the year ended December 31, 2020.

The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the nine months ended September 30, 2021 and 2020, respectively:


	Accruals for Chargebacks, Returns, and Other Allowances
							Administrative		Prompt
			Government				Fees and Other		Payment
(in thousands)	Chargebacks		Rebates		Returns		Rebates		Discounts
Balance at December 31, 2019 (1)	$	49,882	$	8,901	$	16,595	$	8,281	$	2,549
Accruals/Adjustments		288,538		14,288		22,744		27,383		10,248
Credits Taken Against Reserve		(262,531)		(11,511)		(16,089)		(27,287)		(9,442)
Balance at September 30, 2020 (1)	$	75,889	$	11,678	$	23,250	$	8,377	$	3,355

Balance at December 31, 2020 (1)	$	88,746	$	7,826	$	27,155	$	8,906	$	3,839
Accruals/Adjustments		343,117		31,515		16,043		74,594		31,138
Credits Taken Against Reserve		(333,867)		(27,628)		(10,969)		(75,877)		(30,876)
Balance at September 30, 2021 (1)	$	97,996	$	11,713	$	32,229	$	7,623	$	4,101

(1)

Chargebacks are included as an offset to accounts receivable in the unaudited condensed consolidated balance sheets. Administrative Fees and Other Rebates and Prompt Payment Discounts are included as an offset to accounts receivable or as accrued expenses and other in the unaudited condensed consolidated balance sheets. Returns are included in returned goods reserve in the unaudited condensed consolidated balance sheets. Government Rebates are included in accrued government rebates in the unaudited condensed consolidated balance sheets.

Contract Manufacturing Product Sales Revenue

Contract manufacturing arrangements consist of agreements in which we manufacture a pharmaceutical product on behalf of a third party. Our performance obligation is to manufacture and provide pharmaceutical products to customers, typically pharmaceutical companies. The contract manufactured products are sold at pre-determined standalone selling prices and our performance obligations are considered to be satisfied when control of the product is transferred to the customer. Control is transferred to the customer when the product leaves our dock to be shipped to the customer, as our contract manufactured pharmaceutical products are sold on an FOB shipping point basis and the inventory risk and risk of ownership passes to the customer at that time. Payment terms for these sales are generally fewer than two months. We estimate returns based on historical experience. Historically, we have not had material returns for contract manufactured products.

As of September 30, 2021, the aggregate amount of the transaction price allocated to the remaining performance obligations for all open contract manufacturing customer contracts was $3.0 million, which consists of firm orders

for contract manufactured products. We will recognize revenue for these performance obligations as they are satisfied, which is anticipated within six months.

Royalties from Licensing Agreements

From time to time, we enter into transition agreements with the sellers of products we acquire, under which we license to the seller the right to sell the acquired products. Therefore, we recognize the revenue associated with sales of the underlying products as royalties. Because these royalties are sales-based, we recognize the revenue when the underlying sales occur, based on sales and gross profit information received from the sellers. Upon full transition of the products and upon launching the products under our own labels, we recognize revenue for the products as sales of generic or branded pharmaceutical products, as described above. From time to time, we enter into supply and distribution agreements with contract manufacturing customers, under which we license to the contract manufacturing customer the right to sell our products, and we are entitled to a royalty on sales made by the contract manufacturing customer under these arrangements. Therefore, we recognize the revenue associated with sales of the underlying products as royalties. Because these royalties are sales-based, we recognize the revenue when the underlying sales occur, based on sales and gross profit information received from the contract manufacturing customers.

Pursuant to a 2012 Tripartite Agreement (the “Tripartite Agreement”) between the Company, The Regents of the University of California (“The Regents”), and Cabaret Biotech Ltd., an Israeli corporation (“Cabaret”) (as assignee of Dr. Zelig Eshhar’s rights under the Tripartite Agreement), and subsequent amendments thereto and assignments thereof, we were entitled to receive a percentage of the milestone and sales royalty payments paid to Cabaret by Kite Pharma, Inc. (“Kite”), a subsidiary of Gilead Sciences, Inc., under a license agreement. Under such license agreement, Kite licensed from Dr. Eshhar and Cabaret the patent rights covered by the Tripartite Agreement and agreed to make certain payments to Cabaret based on, among other things, Kite’s sales of Yescarta®. Under the Tripartite Agreement, portions of these payments were to be distributed to The Regents and to us.

Historically, we recorded royalty income related to Yescarta® on an accrual basis utilizing our best estimate of royalties earned based upon information available in the public domain, our understanding of the various agreements governing the royalty, and other information received from time to time from the relevant parties. Generally, cash was received directly from Cabaret once a year. The agreements governing this royalty were subject to multiple actions in multiple jurisdictions, including litigation between Cabaret and Kite, and separately, ANI and Cabaret. In the first quarter of 2021, we became aware that the litigation between Cabaret and Kite was dismissed. In April 2021, Cabaret and the Company settled all amounts due for amounts actually received by Cabaret or Eshhar for the licensing or use of the patent rights governed by the Kite license agreement. As a result, we recognized $11.2 million as royalties from licensing agreements in our net revenues during the three month period ended March 31, 2021. In addition, we agreed to reimburse Cabaret $0.4 million, which has been recorded as other expense, net in the accompanying unaudited interim condensed consolidated statement of operations, related to certain legal expenditures incurred. We received final payment from Cabaret in May 2021. Based upon the events that led to the dismissal of the litigation between Cabaret and Kite, the Company does not expect to receive any future royalty income related to the Kite license agreement. In conjunction with payment of amounts due to us, all outstanding litigation between the Company and Cabaret were dismissed.

Product Development Services Revenue

We provide product development services to customers, which are performed over time. These services primarily relate to the technical transfer of product development to our facility in Oakville, Ontario. The duration of these technical transfer projects can be up to three years. Deposits received from these customers are recorded as deferred revenue until revenue is recognized. For contracts with no deposits and for the remainder of contracts with deposits, we invoice customers as our performance obligations are satisfied. We recognize revenue on a percentage of completion basis, which results in contract assets on our balance sheet. As of September 30, 2021, the aggregate

amount of the transaction price allocated to the remaining performance obligations for all open product development services contracts was $0.4 million. We expect to satisfy these performance obligations within the next six months.

Credit Concentration

Our customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and pharmaceutical companies.

During the three and nine months ended September 30, 2021 and 2020 we had three customers that accounted for 10% or more of net revenues. As of September 30, 2021, accounts receivable from these customers totaled 85% of accounts receivable, net.

The three customers represent the total percentage of net revenues as follows:


	Three Months Ended				Nine Months Ended
	September 30,		September 30,		September 30,		September 30,
	2021		2020		2021		2020
Customer 1	31	%	30	%	29	%	31	%
Customer 2	23	%	25	%	22	%	24	%
Customer 3	17	%	19	%	15	%	19	%

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
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-Name Accounting Standards Codification
-Topic 606
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130558-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
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-Section 50
-Paragraph 12
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130554-203045

+ Details

PENDING BUSINESS COMBINATION

9 Months Ended

Sep. 30, 2021

PENDING BUSINESS COMBINATION

PENDING BUSINESS COMBINATION

3. PENDING BUSINESS COMBINATION

On March 8, 2021, we entered into a definitive agreement to acquire Novitium Pharma LLC (“Novitium”), a privately held New Jersey-based pharmaceutical company with development, manufacturing, and commercial capabilities (the “Acquisition”). The closing of the Acquisition will occur (a) within five business days after all of the conditions to the closing set forth in the merger agreement are satisfied or waived or (b) at such other time, date and place as may be agreed by us and Novitium, subject to the completion of a minimum period. The closing is subject to the satisfaction of customary closing conditions and necessary regulatory approvals.

Consideration will consist of a combination of (i) an estimated cash amount of $89.5 million, subject to various adjustments and expected to be financed by a $25.0 million private placement of preferred stock (the “PIPE Investment”) and by new debt financing, both described below, (ii) an aggregate of 2,466,667 shares of ANI common stock, and (iii) up to $46.5 million in contingent future earn-out payments.

We will finance the transaction with a new $340.0 million Senior Secured Credit Facility (the “New Facility”), consisting of a $300.0 million term loan and a $40.0 million revolving credit facility, the issuance of 2,466,667 shares of ANI common stock (approximately $74.0 million in value based on a $30.00 stock price) (the “Stock Consideration”), and a $25.0 million PIPE Investment by Ampersand 2020 Limited Partnership (“Ampersand”), an affiliate of Ampersand Capital Partners of which ANI’s Chairman of the Board is an operating partner and as such Ampersand is a related party. At closing, we intend to use the proceeds from the New Facility to fund a portion of the Acquisition and repay all of the outstanding debt under the existing senior secured credit facility discussed in Note 4.

The New Facility will be secured by substantially all the assets of ANI and its subsidiaries and used for the cash portion of the acquisition and to refinance ANI’s existing senior credit facilities. The term loan portion of the New Facility, which was successfully syndicated on May 24, 2021, represents fully committed capital and, as such, carries a customary ticking fee that commences 45 days and 90 days post allocation. During the three and nine months ended September 30, 2021, we incurred $2.4 million in expense related to the ticking fee, all of which was recognized as other expense, net, on the unaudited interim condensed consolidated statement of operations. Amounts drawn on the

$300.0 million term loan will bear an interest rate equal to 1-month LIBOR rate plus an applicable margin of 6.00% per annum, or an alternative base rate plus an applicable base rate margin of 5.00% per annum. Amounts drawn on the $40.0 million revolving credit facility will bear an interest rate equal to 1-month LIBOR rate plus an applicable margin of 4.75% per annum, or an alternative base rate plus an applicable base rate margin of 3.75% per annum. On the revolving credit facility, we will incur a commitment fee on any unused portion at a rate of 0.50% per annum.

As discussed in Note 5, we currently have an interest rate swap to manage our exposure to changes in LIBOR-based interest rates underlying total borrowings under our Term Loan and DDTL. We intend to retain an interest rate swap with similar structure and terms in order to manage our exposure to changes in LIBOR-based interest rates underlying a portion of borrowings under the New Facility.

Concurrently with the execution of the definitive agreement, on March 8, 2021, we entered into an Equity Commitment and Investment Agreement with Ampersand (the “PIPE Investor”), pursuant to which we agreed to issue and sell to the PIPE Investor, and the PIPE Investor agreed to purchase, 25,000 shares of our Series A Convertible Preferred Stock (the “PIPE Shares”), for a purchase price of $1,000 per share and an aggregate purchase price of $25.0 million PIPE Investment. The issuance of shares of ANI common stock into which PIPE Shares will be convertible and the Stock Consideration for the Acquisition were approved by the ANI stockholders in June 2021.

During the three and nine months ended September 30, 2021, we incurred $0.5 million and $5.1 million, respectively, in transaction costs related to this pending Acquisition, all of which were expensed and recognized as selling, general, and administrative expenses on the unaudited interim condensed consolidated statements of operations.

INDEBTEDNESS

9 Months Ended

Sep. 30, 2021

INDEBTEDNESS

INDEBTEDNESS

4.	INDEBTEDNESS

Credit Facility

Our five-year Senior Secured Credit Facility (the “Credit Facility”) is comprised of a $72.2 million term loan (the “Term Loan”), a $118.0 million delayed draw term loan (“DDTL”), and a $75.0 million revolving credit facility (the “Revolver”), all of which mature in December 2023. The Credit Facility has a subjective acceleration clause in case of a material adverse event. The Term Loan includes a repayment schedule, pursuant to which $6.8 million of the loan will be paid in quarterly installments during the 12 months ending September 30, 2022. As of September 30, 2021, $6.8 million of the Term Loan is recorded as current borrowings in the consolidated balance sheets. The DDTL includes a repayment schedule, pursuant to which $9.6 million will be paid in quarterly installments during the 12 months ending September 30, 2022. As of September 30, 2021, $9.6 million of the DDTL is recorded as current borrowings in the consolidated balance sheets. As of September 30, 2021, there is $31.5 million outstanding and payable on our Revolver, all of which is recorded as a long-term borrowing on the consolidated balance sheets. As of September 30, 2021, $43.5 million remained available for borrowing under the Revolver. Amounts drawn on the Term Loan, DDTL, and Revolver bear an interest rate equal to, at our option, either a 1-month LIBOR rate plus 1.50% to 2.75% per annum, depending on our total leverage ratio or an alternative base rate plus an applicable base rate margin, which varies within a range of 0.50% to 1.75%, depending on our total leverage ratio. On the Revolver, we incur a commitment fee at a rate per annum that varies within a range of 0.25% to 0.50%, depending on our leverage ratio. As of September 30, 2021, our interest rate on outstanding borrowings was 1-month LIBOR plus 2.00% and our commitment fee rate was 0.4%.

The Credit Facility is secured by a lien on substantially all of ANI Pharmaceuticals, Inc.’s and its principal domestic subsidiary’s assets and any future domestic subsidiary guarantors’ assets. The Credit Facility is subject to customary financial and nonfinancial covenants.

The carrying value of the current and non-current components of the Term Loan and DDTL as of September 30, 2021 and December 31, 2020 are:


	Current
	September 30,		December 31,
(in thousands)	2021		2020
Current borrowing on debt	$	16,355	$	13,691
Deferred financing costs		(428)		(448)
Current debt, net of deferred financing costs	$	15,927	$	13,243


	Non-Current
	September 30,		December 31,
(in thousands)	2021		2020
Non-current borrowing on debt	$	155,057	$	165,755
Deferred financing costs		(494)		(812)
Non-current debt, net of deferred financing costs and current component	$	154,563	$	164,943

As of September 30, 2021, we had a $62.3 million balance on the Term Loan, $109.2 million balance on the DDTL, and $31.5 million balance on the Revolver. Of the $0.6 million of deferred debt issuance costs allocated to the Revolver, $0.3 million is included in other non-current assets in the accompanying unaudited interim condensed consolidated balance sheets and $0.3 million is included in prepaid expenses and other current assets in the accompanying unaudited interim condensed consolidated balance sheets.

The contractual maturity of our Term Loan, DDTL, and Revolver is as follows for the years ending December 31:


(in thousands)	Term Loan		DDTL		Revolver
2021	$	2,707	$	2,950	$	—
2022		5,414		8,850		—
2023		54,141		97,350		31,500
Total	$	62,262	$	109,150	$	31,500

The following table sets forth the components of total interest expense related to the Term Loan, DDTL, and Revolver recognized in the accompanying unaudited interim condensed consolidated statements of operations for the three and nine months ended September 30, 2021 and 2020:


	Three Months Ended				Nine Months Ended
	September 30,		September 30,		September 30,		September 30,
(in thousands)	2021		2020		2021		2020
Contractual coupon	$	2,342	$	2,351	$	7,032	$	6,450
Amortization of finance fees		175		180		527		542
Capitalized interest		(17)		(18)		(74)		(67)
	$	2,500	$	2,513	$	7,485	$	6,925

DERIVATIVE FINANCIAL INSTRUMENT AND HEDGING ACTIVITY

9 Months Ended

Sep. 30, 2021

DERIVATIVE FINANCIAL INSTRUMENT AND HEDGING ACTIVITY

DERIVATIVE FINANCIAL INSTRUMENT AND HEDGING ACTIVITY

5.	DERIVATIVE FINANCIAL INSTRUMENT AND HEDGING ACTIVITY

At times we use derivative financial instruments to hedge our exposure to interest rate risks. All derivative financial instruments are recognized as either assets or liabilities at fair value on the consolidated balance sheet and are classified as current or non-current based on the scheduled maturity of the instrument.

When we enter into a hedge arrangement and intend to apply hedge accounting, we formally document the hedge relationship and designate the instrument for financial reporting purposes as a fair value hedge, a cash flow hedge,

or a net investment hedge. When we determine that a derivative financial instrument qualifies as a cash flow hedge and is effective, the changes in fair value of the instrument are recorded in accumulated other comprehensive loss, net of tax in our consolidated balance sheets and will be reclassified to earnings when the hedged item affects earnings.

In December 2018, we refinanced our previous credit agreement and, at the same time, entered into an interest rate swap, which was considered a derivative financial instrument, with Citizens Bank, N.A. to manage our exposure to changes in LIBOR-based interest rates underlying our Term Loan. In February 2019, we entered into an interest rate swap, which was considered a derivative financial instrument, with Citizens Bank, N.A. to manage our exposure to changes in LIBOR-based interest rates underlying our DDTL. The hedges had been designated as effective cash flow hedges and qualified for hedge accounting. The interest rate swaps related to the Term Loan and DDTL had a weighted average fixed rate of 2.60% and 2.47%, respectively, with a maturity in December 2023. In April 2020, we terminated the remaining $184.2 million notional value of these interest rate swaps and are recognizing the net loss in accumulated other comprehensive loss at the time of the termination to interest expense over the remaining terms through December 2023.

At the same time in April 2020, we entered into an interest rate swap with Citizens Bank, N.A. to manage our exposure to changes in LIBOR-based interest rates underlying total borrowings under our Term Loan and DDTL. The interest rate swap matures in December 2026. As of September 30, 2021, the notional amount of the interest rate swap was $171.4 million and decreases in line with maturities of our Term Loan and DDTL until December 2023, after which it remains static until maturity in 2026. The interest rate swap provides an effective fixed rate of 1.99% and has been designated as an effective cash flow hedge and therefore qualifies for hedge accounting. The interest rate swap effectively provides a fixed rate of interest throughout the life of our Term Loan and DDTL. As of September 30, 2021, the fair value of the interest rate swap liability was valued at $7.9 million and was recorded in derivatives and other non-current liabilities in the accompanying unaudited interim condensed consolidated balance sheets. As of September 30, 2021, $4.2 million was recorded in accumulated other comprehensive loss, net of tax in the accompanying unaudited interim condensed consolidated balance sheets.

During the three and nine months ended September 30, 2021, the change in the fair value of the interest rate swap of $0.6 million, net of $0.3 million of tax and $4.7 million, net of $0.2 million of tax, was recorded in accumulated other comprehensive income, net of tax in our unaudited interim condensed consolidated statements of comprehensive income/(loss). Differences between the hedged 1-month LIBOR rate and the fixed rate are recorded as interest expense in the same period that the related interest is recorded for the Term Loan and DDTL based on the 1-month LIBOR rate. In the three and nine months ended September 30, 2021, $1.3 million and $3.7 million of interest expense was recognized in relation to the interest rate swap, respectively.

EARNINGS (LOSS) PER SHARE

9 Months Ended

Sep. 30, 2021

EARNINGS (LOSS) PER SHARE

EARNINGS (LOSS) PER SHARE

6.	EARNINGS (LOSS) PER SHARE

Basic earnings (loss) per share is computed by dividing net income (loss) available to common shareholders by the weighted-average number of shares of common stock outstanding during the period.

For periods of net income, and when the effects are not anti-dilutive, we calculate diluted earnings (loss) per share by dividing net income available to common shareholders by the weighted-average number of shares outstanding plus the impact of all potential dilutive common shares, consisting primarily of common stock options, shares to be purchased under our Employee Stock Purchase Plan (“ESPP”), unvested restricted stock awards, and stock purchase warrants, using the treasury stock method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share.

Our unvested restricted shares contain non-forfeitable rights to dividends, and therefore are considered to be participating securities; in periods of net income, the calculation of basic and diluted earnings (loss) per share excludes from the numerator net income (but not net loss) attributable to the unvested restricted shares, and excludes the impact of those shares from the denominator.

Earnings (loss) per share for the three and nine months ended September 30, 2021 and 2020 are calculated for basic and diluted earnings (loss) per share as follows:


	Basic				Diluted				Basic				Diluted
(in thousands, except per share amounts)	Three Months Ended September 30,				Three Months Ended September 30,				Nine Months Ended September 30,				Nine Months Ended September 30,
	2021		2020		2021		2020		2021		2020		2021		2020
Net (loss)/income	$	(4,447)	$	434	$	(4,447)	$	434	$	(18,467)	$	(18,913)	$	(18,467)	$	(18,913)
Net income allocated to restricted stock		—		(12)		—		(13)		—		—		—		—
Net (loss)/income allocated to common shares	$	(4,447)	$	422	$	(4,447)	$	421	$	(18,467)	$	(18,913)	$	(18,467)	$	(18,913)
Basic Weighted-Average Shares Outstanding		12,107		11,991		12,107		11,991		12,066		11,953		12,066		11,953
Dilutive effect of stock options and ESPP						—		12						—		—
Diluted Weighted-Average Shares Outstanding						12,107		12,003						12,066		11,953

(Loss)/Income per share	$	(0.37)	$	0.04	$	(0.37)	$	0.04	$	(1.53)	$	(1.58)	$	(1.53)	$	(1.58)

The number of anti-dilutive shares, which have been excluded from the computation of diluted earnings (loss) per share, was 1.6 million and 1.1 million for the three months ended September 30, 2021 and 2020, and was 1.7 million and 1.3 million for the nine months ended September 30, 2021 and 2020, respectively. For the three months ended September 30, 2021 and the nine months ended September 30, 2021 and 2020, all potentially dilutive shares were anti-dilutive and excluded from the calculation of diluted loss per share because we recognized a net loss. For the three months ended September 30, 2020, anti-dilutive shares consist of out-of-the-money Class C Special stock, out-of-the-money common stock options, and unvested restricted stock awards and common stock options that are anti-dilutive when calculating the impact of the potential dilutive common shares using the two-class or treasury stock method.

INVENTORIES

9 Months Ended

Sep. 30, 2021

INVENTORIES

INVENTORIES

7.	INVENTORIES

Inventories consist of the following as of:


	September 30,		December 31,
(in thousands)	2021		2020
Raw materials	$	33,995	$	41,591
Packaging materials		3,631		3,194
Work-in-progress		814		886
Finished goods		28,460		20,363
		66,900		66,034
Reserve for excess/obsolete inventories		(5,216)		(5,231)
Inventories, net	$	61,684	$	60,803

Vendor Concentration

We source the raw materials for our products, including active pharmaceutical ingredients (“API”), from both domestic and international suppliers. Generally, only a single source of API is qualified for use in each product due to the cost and time required to validate a second source of supply. As a result, we are dependent upon our current vendors to reliably supply the API required for on-going product manufacturing. During the three and nine months ended September 30, 2021, no single vendor represented at least 10% of inventory purchases. During the three months ended September 30, 2020, we purchased approximately 14% of our inventory from one supplier. During the nine months ended September 30, 2020, we purchased approximately 12% of our inventory from one supplier. purchases.

GOODWILL AND INTANGIBLE ASSETS

9 Months Ended

Sep. 30, 2021

GOODWILL AND INTANGIBLE ASSETS

GOODWILL AND INTANGIBLE ASSETS

8.	GOODWILL AND INTANGIBLE ASSETS

Goodwill

As a result of our 2013 merger with BioSante Pharmaceuticals, Inc. (“BioSante”), we recorded goodwill of $1.8 million. As a result of our acquisition of WellSpring Pharma Services Inc., we recorded additional goodwill of $1.7 million in 2018. We assess the recoverability of the carrying value of goodwill as of October 31^st of each year, and whenever events occur or circumstances change that would, more likely than not, reduce the fair value of our reporting unit below its carrying value. There have been no events or changes in circumstances that would have reduced the fair value of our reporting unit below its carrying value during the nine months ended September 30, 2021. No impairment losses were recognized during the three and nine months ended September 30, 2021 and 2020.

Definite-lived Intangible Assets

The components of net definite-lived intangible assets are as follows:


	September 30, 2021				December 31, 2020				Weighted Average
	Gross Carrying		Accumulated		Gross Carrying		Accumulated		Amortization
(in thousands)	Amount		Amortization		Amount		Amortization		Period
Acquired ANDA intangible assets	$	106,415	$	(51,684)	$	106,415	$	(42,367)	8.8	years
NDAs and product rights		242,372		(132,146)		230,974		(112,483)	9.9	years
Marketing and distribution rights		17,157		(12,107)		17,157		(11,386)	5.7	years
Non-compete agreement		624		(490)		624		(423)	7.0	years
	$	366,568	$	(196,427)	$	355,170	$	(166,659)	9.4	years

Definite-lived intangible assets are stated at cost, net of amortization, generally using the straight-line method over the expected useful lives of the intangible assets. In the case of certain New Drug Application (“NDA”) and product rights assets, we use an accelerated amortization method to better match the anticipated economic benefits expected to be provided. Amortization expense was $10.1 million for the three months ended September 30, 2021 and 2020. Amortization expense was $29.8 million and $30.2 million for the nine months ended September 30, 2021 and 2020, respectively. Refer to Note 12 for more details on acquired definite-lived intangible assets.

We test for impairment of definite-lived intangible assets when events or circumstances indicate that the carrying value of the assets may not be recoverable. No such triggering events were identified during the three and nine months ended September 30, 2021 and 2020 and therefore no impairment loss was recognized in the three and nine months ended September 30, 2021 and 2020.

Expected future amortization expense is as follows:


(in thousands)
2021	$	10,057
2022		36,828
2023		36,080
2024		33,103
2025		29,755
2026 and thereafter		24,318
Total	$	170,141

STOCK-BASED COMPENSATION

9 Months Ended

Sep. 30, 2021

STOCK-BASED COMPENSATION

STOCK-BASED COMPENSATION

9.	STOCK-BASED COMPENSATION

Employee Stock Purchase Plan

In July 2016, we commenced administration of the ANI Pharmaceuticals, Inc. 2016 Employee Stock Purchase Plan. As of September 30, 2021, we had 0.2 million shares of common stock available under the ESPP. Under the ESPP, participants can purchase shares of our stock at a 15% discount.

The following table summarizes ESPP expense incurred under the 2016 Employee Stock Purchase Plan and included in our accompanying unaudited interim condensed consolidated statements of operations:


(in thousands)	Three Months Ended September 30,				Nine Months Ended September 30,
	2021		2020		2021		2020
Cost of sales	$	3	$	3	$	11	$	14
Research and development		5		6		16		25
Selling, general, and administrative		20		23		66		79
	$	28	$	32	$	93	$	118

Stock Incentive Plan

Equity-based service awards are granted under the ANI Pharmaceuticals, Inc. Amended and Restated 2008 Stock Incentive Plan (the “2008 Plan”). As of September 30, 2021, 0.6 million shares of our common stock were available for issuance under the 2008 Plan.

From time to time, we may grant stock options to employees through an inducement grant outside of our 2008 Plan to induce prospective employees to accept employment with us (the “Inducement Grants”). The options are granted at an exercise price equal to the fair market value of a share of our common stock on the respective grant date and are generally exercisable in four equal annual installments beginning on the first anniversary of the respective grant date. The grants are made pursuant to inducement grants outside of our stockholder approved equity plan as permitted under the Nasdaq Stock Market listing rules.

The following table summarizes stock-based compensation expense incurred under the 2008 Plan and Inducement Grants included in our accompanying unaudited interim condensed consolidated statements of operations:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2021		2020		2021		2020
Cost of sales	$	2	$	34	$	4	$	93
Research and development		144		117		407		450
Selling, general, and administrative		2,634		2,200		7,017		9,882
	$	2,780	$	2,351	$	7,428	$	10,425

A summary of stock option and restricted stock activity under the 2008 Plan and Inducement Grants during the nine months ended September 30, 2021 and 2020 is presented below:


(in thousands)	Options	Inducement Grants	RSAs
Outstanding at December 31, 2019	757	—	192
Granted	42	180	305
Options Exercised/RSAs Vested	(8)	—	(128)	⁽¹⁾
Forfeited	(44)	—	(17)
Expired	—	—	—
Outstanding at September 30, 2020	747	180	352

Outstanding at December 31, 2020	756	180	352
Granted	97	61	463
Options Exercised/RSAs Vested	(5)	—	(126)	⁽²⁾
Forfeited	(74)	—	(61)
Expired	—	—	—
Outstanding at September 30, 2021	774	241	628

(1)

Includes 43 thousand shares purchased from employees to cover employee income taxes related to income earned upon vesting of restricted stock. The shares purchased are held in treasury and the $1.5 million total purchase price for the shares is included in Treasury stock in our accompanying unaudited interim condensed consolidated balance sheets.

(2)

Includes 28 thousand shares purchased from employees to cover employee income taxes related to income earned upon vesting of restricted stock. The shares purchased are held in treasury and the $0.9 million total purchase price for the shares is included in Treasury stock in our accompanying unaudited interim condensed consolidated balance sheets.

INCOME TAXES

9 Months Ended

Sep. 30, 2021

INCOME TAXES

INCOME TAXES

10.	INCOME TAXES

We use the asset and liability method of accounting for income taxes. Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted.

The measurement of a deferred tax asset is reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized. As of September 30, 2021, we have

provided a valuation allowance against consolidated net deferred tax assets of $0.4 million, related solely to deferred tax assets for net operating loss carryforwards in certain U.S. state jurisdictions.

We use a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. We have not identified any uncertain income tax positions that could have a material impact on the consolidated financial statements. We recognize interest and penalties accrued on any unrecognized tax exposures as a component of income tax expense; we did not have any such amounts accrued as of September 30, 2021 and December 31, 2020. We are subject to taxation in various U.S. jurisdictions and all of our income tax returns remain subject to examination by tax authorities due to the availability of NOL carryforwards.

For interim periods, we recognize an income tax provision/(benefit) based on our estimated annual effective tax rate, calculated on a worldwide consolidated basis, expected for the entire year. The interim annual estimated effective tax rate is based on the statutory tax rates then in effect, as adjusted for estimated changes in temporary and estimated permanent differences, and excludes certain discrete items whose tax effect, when material, is recognized in the interim period in which they occur. These changes in temporary differences, permanent differences, and discrete items result in variances to the effective tax rate from period to period. We also have elected to exclude the impacts from significant pre-tax non-recognized subsequent events from our interim estimated annual effective rate until the period in which they occur. Prior to the adoption of new accounting guidance that we adopted on a prospective basis on January 1, 2021, during periods when we incurred net losses before income taxes, our annual estimated effective tax rate was at times adjusted based on the “loss limitation” requirements applicable to interim tax provisions, resulting in a limited income tax benefit recognized in that period. Under these provisions, our income tax benefit for the three months ended March 31, 2020 (but not for the three and nine month periods ended September 30, 2020) was limited. The “loss limitation” requirements were removed by the new accounting guidance and, therefore, we were not required to assess any such limitation for 2021. Our estimated annual effective tax rate changes throughout the year as our on-going estimates of pre-tax income, changes in temporary differences, and permanent differences are revised, and as discrete items occur. Global Intangible Low-Taxed Income (“GILTI”), as defined in the Tax Cuts and Jobs Act of 2017, generated from our Canadian operations is subject to U.S. taxes, with certain defined exemptions, thresholds and credits. For financial reporting purposes we have elected to treat GILTI inclusions as a period cost.

For the three months ended September 30, 2021, we recognized an income tax benefit of $2.7 million. The income tax benefit resulted from applying an estimated annual worldwide effective tax benefit rate of 37.6% to pre-tax consolidated loss of $7.1 million reported during the period, as well as the net effects of certain discrete items occurring which impact our income tax provision in the period in which they occur. There were no material discrete items occurring during the three months ended September 30, 2021.

For the three months ended September 30, 2020, we recognized an income tax benefit of $0.4 million. The income tax benefit for this period is the incremental benefit generated from applying the estimated annual worldwide effective tax benefit rate of 19.8% to consolidated pre-tax losses for the nine months ended September 30, 2020 as compared to the consolidated income tax benefit as of June 30, 2020. The estimated annual effective rate varies from the statutory rate as a result of permanent differences as well as the net effects of certain discrete items

occurring which impact our income tax provision in the period in which they occur. There were no material discrete items during the three months ended September 30, 2020.

For the nine months ended September 30, 2021, we recognized an income tax benefit of $6.7 million. The income tax benefit resulted from applying an estimated annual worldwide effective tax benefit rate of 26.7% to pre-tax consolidated loss of $25.2 million reported during the period, as well as the net effects of certain discrete items occurring which impact our income tax provision in the period in which they occur. There were no material discrete items occurring during the nine months ended September 30, 2021.

For the nine months ended September 30, 2020, we recognized an income tax benefit of $4.7 million. The income tax benefit resulted from applying an estimated annual worldwide effective tax benefit rate of 19.8% to pre-tax consolidated loss of $23.6 million reported during the period, as well as the net effects of certain discrete items occurring which impact our income tax provision in the period in which they occur. There were no material discrete items during the nine months ended September 30, 2020.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References + Details

COMMITMENTS AND CONTINGENCIES

9 Months Ended

Sep. 30, 2021

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES

11.	COMMITMENTS AND CONTINGENCIES

Operating Leases

All our existing leases as of September 30, 2021 are classified as operating leases. As of September 30, 2021, we have nine material operating leases for facilities and office equipment with remaining terms expiring from 2022 through 2026 and a weighted average remaining lease term of 2.5 years. Many of our existing leases have fair value renewal options, none of which are considered certain of being exercised or included in the minimum lease term. Discount rates used in the calculation of our lease liability ranged between 3.99% and 8.95%.

Rent expense for the three and nine months ended September 30, 2021 and 2020 consisted of the following:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2021		2020		2021		2020
Operating lease costs	$	40	$	57	$	132	$	166
Variable lease costs		9		15		30		44
Total lease costs	$	49	$	72	$	162	$	210

A maturity analysis of our operating leases follows:


(in thousands)
Future payments:
2021	$	35
2022		127
2023		82
2024		56
2025 and thereafter		42
Total	$	342

Discount		(22)
Lease liability		320
Current lease liability		(130)
Non-current lease liability	$	190

Government Regulation

Our products and facilities are subject to regulation by a number of federal and state governmental agencies, such as the Drug Enforcement Administration (“DEA”), the U.S. Food and Drug Administration (“FDA”), the Centers for Medicare and Medicaid Services (“CMS”), and Health Canada. The FDA, in particular, maintains oversight of the formulation, manufacture, distribution, packaging, and labeling of all of our products. The DEA and Health Canada maintain oversight over our products that are considered controlled substances.

Unapproved Products

Two of our products, Esterified Estrogen with Methyltestosterone (“EEMT”) and Opium Tincture, are marketed without approved NDAs or Abbreviated New Drug Applications (“ANDAs”). During the three months ended September 30, 2021 and 2020, net revenues for these products totaled $4.2 million and $4.3 million, respectively. During the nine months ended September 30, 2021 and 2020, net revenues for these products totaled $12.2 million and $12.4 million, respectively.

In addition, one group of products that we manufacture on behalf of a contract customer is marketed by that customer without an approved NDA. If the FDA took enforcement action against such customer, the customer may be required to seek FDA approval for the group of products or withdraw them from the market. Our contract manufacturing revenues for the group of unapproved products for the three months ended September 30, 2021 and 2020 were $0.7 million. Our contract manufacturing revenues for the group of unapproved products for the nine months ended September 30, 2021 and 2020 were $2.1 million and $2.3 million, respectively.

Legal Proceedings

We are involved, and from time to time may become involved, in various disputes, governmental and/or regulatory inquiries, investigations, government reimbursement related actions and litigation. These matters are complex and subject to significant uncertainties. As such, we cannot accurately predict the outcome, or the effects of the legal proceedings described below. While we believe that we have valid claims and/or defenses in the litigation and other matters described below, litigation is inherently unpredictable, and the outcome of the proceedings could result in losses, including substantial damages, fines, civil or criminal penalties and injunctive or administrative remedies. We intend to vigorously prosecute and/or defend these matters, as appropriate, however, from time to time, we may settle or otherwise resolve these matters on terms and conditions that we believe are in our best interests. Resolution of any or all claims, investigations, and legal proceedings, individually or in the aggregate, could have a material adverse effect on our results of operations and/or cash flows in any given accounting period or on our overall financial condition.

Some of these matters with which we are involved are described below, and unless otherwise disclosed, we are unable to predict the outcome of the matter or to provide an estimate of the range of reasonably possible material losses. We record accruals for loss contingencies to the extent we conclude it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated.

From time to time, we are also involved in other pending proceedings for which, in our opinion based upon facts and circumstances known at the time, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to our results, and therefore remain undisclosed. If and when any reasonably possible losses associated with the resolution of such other pending proceedings, in our opinion, become material, we will disclose such matters.

Furthermore, like all pharmaceutical manufacturers, we are periodically exposed to product liability claims. The prevalence of these claims could limit our coverage under future insurance policies or cause those policies to become more expensive, which could harm our business, financial condition, and operating results. Recent trends in the product liability and director and officer insurance markets is to exclude matters related to certain classes of drugs. Our policies have been subject to such exclusions which place further potential risk of financial loss on us.

Legal fees for litigation-related matters are expensed as incurred and included in the consolidated statements of operations under the selling, general, and administrative expense line item.

Commercial Litigation

In November of 2017, we were served with a complaint filed by Arbor Pharmaceuticals, LLC, in the United States District Court for the District of Minnesota. The complaint alleged false advertising and unfair competition in violation of Section 43(a) of the Lanham Act, Section 1125(a) of Title 15 of the United States Code, and Minnesota State law, under the premise that we sold an unapproved Erythromycin Ethylsuccinate (“EES”) product during the period between September 27, 2016 and November 2, 2018. The complaint sought a trial by jury and monetary damages (inclusive of actual and consequential damages, treble damages, disgorgement of ANI profits, and legal fees) of an unspecified amount. Discovery in this action closed on March 31, 2019 and trial was scheduled to commence on August 25, 2021. On August 3, 2021, the Company entered into a Settlement Agreement with Arbor Pharmaceuticals, LLC to resolve all claims related to Civil Action 17-4910, Arbor Pharmaceuticals, LLC (“Arbor”) v. ANI Pharmaceuticals, Inc., which was pending trial in the United States District Court for the District of Minnesota. Under the terms of the agreement, ANI paid Arbor $8.4 million and Arbor dismissed the action with prejudice. Neither party admitted wrongdoing in reaching this settlement. The Company paid the settlement from cash on the balance sheet.

On December 3, 2020, class action complaints were filed against the Company on behalf of putative classes of direct and indirect purchasers of the drug Bystolic. On December 23, 2020, six individual purchasers of Bystolic, CVS, Rite Aid, Walgreen, Kroger, Albertsons, and H-E-B, filed complaints against the Company. On March 15, 2021, the plaintiffs in these actions filed amended complaints. All amended complaints are substantively identical. The plaintiffs in these actions allege that, beginning in 2012, Forest Laboratories, the manufacturer of Bystolic, entered into anticompetitive agreements when settling patent litigation related to Bystolic with seven potential manufacturers of a generic version of Bystolic: Hetero, Torrent, Alkem/Indchemie, Glenmark, Amerigen, Watson, and various of their corporate parents, successors, subsidiaries, and affiliates. ANI itself was not a party to patent litigation with Forest concerning Bystolic and did not settle patent litigation with Forest. The plaintiffs named the Company as a defendant based on the Company’s January 8, 2020 Asset Purchase Agreement with Amerigen. The complaints allege that the 2013 patent litigation settlement agreement between Forest and Amerigen violates federal and state antitrust laws and state consumer protection laws by delaying the market entry of generic versions of Bystolic. Plaintiffs allege they paid higher prices as a result of delayed generic competition. Plaintiffs seek damages, trebled or otherwise multiplied under applicable law, injunctive relief, litigation costs and attorneys’ fees. The complaints do not specify the amount of damages sought from the Company or other defendants and the Company at this early stage of the litigation cannot reasonably estimate the potential damages that the plaintiffs will seek. The cases have been consolidated in the United States District Court for the Southern District of New York as In re Bystolic Antitrust Litigation, Case No. 20-cv-005735 (LJL). On April 23, 2021, the Company and other defendants filed motions to dismiss the amended complaints, which are pending before the court for decision. The Company disputes any liability in these matters.

On March 24, 2021, Azurity Pharmaceuticals, Inc. (“Azurity”) filed a complaint in the United States District Court for the District of Minnesota against ANI Pharmaceuticals, Inc., asserting that ANI’s vancomycin hydrochloride oral solution drug product infringes U.S. Patent No. 10,688,046. The complaint seeks injunctive relief, damages, including lost profits and/or royalty, treble damages, and attorneys’ fee and costs. ANI filed its answer on August 31, 2021, and is currently engaged in discovery. ANI intends to dispute any and all liability in this case.

On April 1, 2021, United Therapeutics Corp. and Supernus Pharmaceuticals, Inc. (“UTC/Supernus”) filed a complaint in the United States District Court for the District of Delaware against ANI Pharmaceuticals, Inc., asserting that ANI's proposed Treprostinil extended release drug product, which is subject to ANI’s Abbreviated New Drug Application No. 215667, infringes U.S. Patent Nos. 7,417,070, 7,544,713, 8,252,839, 8,349,892, 8,410,169, 8,747,897, 9,050,311, 9,278,901, 9,393,203, 9,422,223, 9,593,066 and 9,604,901 (“the Asserted Patents”). The complaint seeks injunctive relief, attorneys' fee and costs. ANI filed its answer and counterclaims on May 28, 2021, denying UTC/Supernus’ allegations and seeking declaratory judgment that ANI has not infringed any valid and enforceable claim of the Asserted Patents, that the Asserted Patents are invalid, and an award of attorneys’ fees and costs. Trial is set for May 8, 2023.

Industry Related Litigation

In July 2020, we were served with a complaint brought by the Office of the Attorney General of the State of New Mexico against manufacturers and sellers of ranitidine products. The complaint asserts a public nuisance claim and a negligence claim against the generic ranitidine manufacturer defendants, including the Company. The public nuisance claim asserts that the widespread sale of ranitidine products in the state created a public nuisance that requires a state-wide medical monitoring program of New Mexico residents for the development of colorectal cancer, stomach cancer, gastrointestinal disorders and liver disease. As damages, New Mexico asks that the defendants fund this medical monitoring program. The negligence claims assert that the defendants were negligent in selling the product, essentially alleging that it was unreasonable to have the product on the market. With respect to that claim, New Mexico asserts that it paid for ranitidine products through state-funded insurance and health-care programs. On December 15, 2020, the case was removed to federal court and transferred to the In re Zantac multidistrict litigation (“MDL”) pending in the United States District Court for the Southern District of Florida. New Mexico moved for remand to state court. The MDL court granted the remand motion on February 25, 2021. On April 16, 2021, New Mexico filed an amended complaint in the New Mexico First Judicial District Court in Santa Fe County. It did not name ANI in the amended complaint, effectively voluntarily dismissing ANI from the action. In December 2020, the City of Baltimore served ANI with a complaint against manufacturers and sellers of ranitidine products. The City of Baltimore complaint tracks the allegations of the New Mexico complaint. The Baltimore action was removed to federal court and transferred to the In re Zantac MDL on February 1, 2021. The City of Baltimore moved for remand, which was granted on April 1, 2021. The parties stipulated to allow the City of Baltimore to file an amended complaint in the Circuit Court of Maryland for Baltimore City in “due course,” without a specific filing deadline. On June 23, 2021, the City of Baltimore filed an amended complaint. The City of Baltimore did not name ANI in its amended complaint, effectively voluntarily dismissing ANI from the action. We dispute any liability in these matters.

Product Liability Related Litigation

All manufacturers of the drug Reglan and its generic equivalent metoclopramide, including ANI, have faced allegations from plaintiffs in various states claiming bodily injuries as a result of ingestion of metoclopramide or its brand name, Reglan, prior to the FDA’s February 2009 Black Box warning requirement (“legacy claims”). All these original legacy claims were settled or closed out, including a series of claims in California that were resolved by coordinated proceeding and settlement. Our insurance company assumed the defense of the legacy claims and paid all losses in settlement of the California legacy claims. In March 2019, we were served with a lawsuit in the Superior Court of California, County of Riverside, adding us as a defendant in a complaint filed in July 2017 that is alleged not to have been part of the original settled legacy claims. This new claim was dismissed with prejudice in July 2021 and the matter is now closed.

In June 2020, we were served with a personal injury complaint in the case of Koepsel v. Boehringer Ingelheim Pharmaceuticals, et al., MDL No. 20-MD-2924, Case No. 9:20-cv-80882-RLR, filed in the United States District Court for Southern District of Florida, in which the plaintiff alleges that he developed kidney cancer in 2018 as a result of taking over the counter medication containing ranitidine. The Koepsel action was filed within an existing multidistrict litigation concerning ranitidine-containing drugs pending in the Southern District of Florida before Judge Robin L. Rosenberg, In re Zantac MDL, 20 MDL 2924. A Master Personal Injury Complaint (“MPIC”) in that MDL that was filed on June 22, 2020 also named the Company as a defendant. The Company was dismissed from the Koepsel case on August 21, 2020 and was dismissed from the MPIC on September 8, 2020. On December 31, 2020, after ANI was dismissed, the district court dismissed the MPIC claims against generic manufacturer defendants partially with prejudice and partially with leave to replead. The failure to warn and design defect claims were dismissed with prejudice on preemption grounds. An Amended Master Personal Injury Complaint was filed on February 8, 2021, which does not name ANI. The Company has been named in other individual personal injury complaints filed in MDL 20 MD 2924 in which plaintiffs allege that they developed cancer after taking prescription and over the counter medication containing ranitidine. To date, the Company has been served with complaints in

five of those additional cases: Cooper v. Boehringer Ingelheim Pharmaceuticals, et al., MDL No. 20-MD-2924, Case No. 9:20-cv-81130-RLR (served September 30, 2020), Lineberry v. Amneal Pharmaceuticals, LLC, et al., MDL No. 20-MD-2924, Case No. 9:20-cv-81079-RLR (served August 20, 2020), Lovette v. Amneal Pharmaceuticals, LLC, et al., MDL No. 20-MD-2924, Case No. 9:20-cv-81040-RLR (served August 26, 2020), Hightower v. Pfizer, et al, MDL No. 20-MD-2924, Case No. 9-20-cv-82214-RLR (served December 16, 2020) and Bird v. Boehringer Ingelheim Pharmaceuticals, et al., MDL No. 20-MD-2924, Case No. 9-20-cv-80837-RLR (served December 30, 2020). We have informed counsel for the plaintiffs that we did not sell an over the counter ranitidine product and sold a generic prescription ranitidine product for a limited two-month period of time, from July 2019 to September 2019. Our product was voluntarily recalled in January 2020. Each of the plaintiffs in the five pending cases alleges a cancer diagnosis prior to the time that ANI sold ranitidine, and we have informally sought dismissal from these cases on that basis. ANI was voluntarily dismissed from the Cooper, Lineberry and Lovette actions on November 20, 2020. ANI was voluntarily dismissed from the Bird action on March 15, 2021 and from the Hightower action on March 29, 2021. After ANI had been voluntarily dismissed from all complaints served on it in the MDL, the district court dismissed all claims against the generic manufacturer defendants with prejudice on preemption grounds by opinion dated July 8, 2021. We dispute any liability in these MDL matters.

Other Industry Related Matters

On or about September 20, 2017, the Company and certain of its employees were served with search warrants and/or grand jury subpoenas to produce documents and possibly testify relating to a federal investigation of the

generic pharmaceutical industry. We have been cooperating and intend to continue cooperating with the investigation. However, no assurance can be given as to the timing or outcome of the investigation.

FAIR VALUE DISCLOSURES

9 Months Ended

Sep. 30, 2021

FAIR VALUE DISCLOSURES

FAIR VALUE DISCLOSURES

12.	FAIR VALUE DISCLOSURES

Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value.

The inputs used in measuring the fair value of cash and cash equivalents are considered to be Level 1 in accordance with the three-tier fair value hierarchy. The fair market values are based on period-end statements supplied by the various banks and brokers that held the majority of our funds. The fair value of short-term financial instruments (primarily accounts receivable, prepaid expenses, accounts payable, accrued expenses, and other current liabilities) approximate their carrying values because of their short-term nature. The Term Loan, DDTL, and Revolver bear an interest rate that fluctuates with the changes in LIBOR and, because the variable interest rates approximate market borrowing rates available to us, we believe the carrying values of these borrowings approximated their fair values at September 30, 2021.

Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis

Our contingent value rights (“CVRs”), which were granted coincident with our merger with BioSante and expire in June 2023, are considered contingent consideration and are classified as liabilities. As such, the CVRs were recorded as purchase consideration at their estimated fair value, using level 3 inputs, and are marked to market each reporting period until settlement. The fair value of CVRs is estimated using the present value of our projection of the expected payments pursuant to the terms of the CVR agreement, which is the primary unobservable input. If our projection or expected payments were to increase substantially, the value of the CVRs could increase as a result. The present value of the liability was calculated using a discount rate of 15%. We determined that the fair value of the CVRs was immaterial as of September 30, 2021 and December 31, 2020. We also determined that the changes in such fair value were immaterial in the three and nine months ended September 30, 2021 and 2020.

The fair value of our interest rate swap is estimated based on the present value of projected future cash flows using the LIBOR forward rate curve. The model used to value the interest rate swap includes inputs of readily observable market data, a Level 2 input. As described in detail in Note 5, the fair value of the interest rate swap was a $7.9 million liability at September 30, 2021.

The following table presents our financial assets and liabilities accounted for at fair value on a recurring basis as of September 30, 2021 and December 31, 2020, by level within the fair value hierarchy:


(in thousands)	Fair Value at
Description	September 30, 2021		Level 1		Level 2		Level 3
Liabilities
Interest rate swaps	$	7,926	$	—	$	7,926	$	—
CVRs	$	—	$	—	$	—	$	—


	Fair Value at
Description	December 31, 2020		Level 1		Level 2		Level 3
Liabilities
Interest rate swaps	$	14,109	$	—	$	14,109	$	—
CVRs	$	—	$	—	$	—	$	—

Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis

We do not have any financial assets and liabilities that are measured at fair value on a non-recurring basis.

Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis

We do not have any non-financial assets and liabilities that are measured at fair value on a recurring basis.

Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis

We measure our long-lived assets, including property, plant, and equipment, ROU assets, intangible assets, and goodwill, at fair value on a non-recurring basis. These assets are recognized at fair value when they are deemed to be other-than-temporarily impaired. No such fair value impairment was recognized in the three and nine months ended September 30, 2021 and 2020.

Acquired Non-Financial Assets Measured at Fair Value

In April 2021, we acquired three NDAs and an ANDA and certain related inventories from Sandoz, Inc. for total consideration of $20.7 million. We also incurred and paid $0.4 million in transaction costs directly related to the acquisition. The acquisition was funded via borrowings under our Revolver. We accounted for this transaction as an asset acquisition and capitalized the transaction costs directly related to the acquisition. We recognized $11.4 million as acquired intangible assets and $9.7 million of inventory at fair value, including $0.6 million of API, $1.0 million of sample inventory, and $8.1 million in finished goods inventory. In order to determine the fair value of the intangible assets, we used the present value of the estimated cash flows related to the product rights using a discount rate of 10%, which are level 3 unobservable inputs. The fair value of the inventory was determined based on the estimated selling price to be generated from the finished goods, less costs to sell, including a reasonable margin, which are level 3 unobservable inputs. The intangible assets are being amortized in full over a useful life of seven years and will be tested for impairment when events or circumstances indicate that the carrying value of the asset may not be recoverable. No such triggering events were identified during the period from the date of acquisition to September 30, 2021 and therefore no impairment loss was recognized for the nine months ended September 30, 2021.

In July 2020, we acquired an ANDA and certain related inventories from a private company for total consideration of $4.3 million. We also incurred and paid $0.1 million in transaction costs directly related to the acquisition. We accounted for this transaction as an asset acquisition and capitalized the transaction costs directly related to the acquisition. We recognized $3.0 million as an acquired ANDA intangible asset and $1.4 million in inventory at fair value. The fair value of the inventory was determined based on the estimated selling price to be generated from the finished goods, less costs to sell, including a reasonable margin, which are level 3 unobservable inputs. The ANDA is being amortized in full over its useful life of seven years and will be tested for impairment when events or circumstances indicate that the carrying value of the asset may not be recoverable. No such triggering events were identified during the period from the date of acquisition to June 30, 2021 and therefore no impairment loss was recognized for the nine months ended September 30, 2021.

In January 2020, we completed the acquisition of the U.S. portfolio of 23 generic products and API and finished goods related to certain of those products from Amerigen Pharmaceuticals, Ltd. (“Amerigen”) for a purchase consideration of $56.8 million and up to $25.0 million in contingent payments over the next four years. Payments were made using cash on hand and through borrowings of $15.0 million under our Revolver. We also incurred and paid $0.7 million in transaction costs directly related to the acquisition. We accounted for the transaction as an asset acquisition and capitalized the transactions costs directly related to the acquisition. We recognized $38.5 million as acquired ANDA intangible assets and $6.7 million as acquired marketing and distribution rights related to the licensed products, which are being amortized over their useful lives of seven years. We also recognized $3.8 million of the purchase price as research and development expense because certain of the generic products had significant remaining work required in order to be commercialized and the products did not have an alternative future use. The payment was allocated to the two asset categories and in-process research and development based on relative fair value, which was determined using Level 3 unobservable inputs. To determine the fair value of the acquired intangible assets and in-process research and development, we used the present value of the estimated cash flows related to the products, using a discount rate of 8%. We also recognized $8.4 million in inventory at fair value, including $1.7 million of API and $6.7 million of finished goods. The fair value of the inventory was determined based on the estimated selling price to be generated from the finished goods, less costs to sell, including a reasonable margin, which are level 3 unobservable inputs. Contingent liabilities will be accrued when they are both estimable and probable. The intangible assets will be tested for impairment when events or circumstances indicate that the carrying value of the asset may not be recoverable. No such triggering events were identified during the period from the date of acquisition to September 30, 2021 and therefore no impairment loss was recognized for the nine months ended September 30, 2021.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

PURIFIED CORTROPHIN GEL PRE-LAUNCH CHARGES

9 Months Ended

Sep. 30, 2021

PURIFIED CORTROPHIN GEL PRE-LAUNCH CHARGES

PURIFIED CORTROPHIN GEL PRE-LAUNCH CHARGES

13.PURIFIED CORTROPHIN GEL PRE-LAUNCH CHARGES

In January 2016, we acquired the right, title and interest in the NDAs for Cortrophin Gel and Cortrophin-Zinc. Subsequently, we have assembled a Cortrophin Gel re-commercialization team of scientists, executed a long-term supply agreement with a supplier of pig pituitary glands, our primary raw material for corticotrophin API, executed a long-term supply agreement with an API manufacturer, with whom we have advanced the manufacture of corticotropin API via manufacture of commercial-scale batches, and executed a long-term commercial supply agreement with a current good manufacturing practice (“cGMP”) aseptic fill contract manufacturer.

Prior to the third quarter 2019, all purchases of material, including pig pituitary glands and API, related to the re-commercialization efforts were consumed in research and development activities and recognized as research and development expense in the period in which they were incurred. In the third quarter of 2019, we began purchasing materials that are intended to be used commercially in anticipation of FDA approval of Cortrophin Gel and the resultant product launch. The FDA granted approval of the sNDA of this product on October 29, 2021. Prior to FDA approval, under U.S. GAAP, we were prohibited from capitalizing these pre-launch purchases of materials as inventory, and accordingly, they were charged to expense in the period in which they were incurred. Subsequent to approval, these purchases will be recorded as inventory at net realizable value. During the three and nine months ended September 30, 2021, we incurred $0.2 million and $0.8 million, respectively, of charges for the purchase of materials. During the three and nine months ended September 30, 2020, we incurred $0.1 million and $8.3 million,

respectively in charges for the purchase of materials. We also incurred other charges directly related to the Cortrophin pre-launch commercialization efforts, including, but not limited to, sales and marketing and consulting expenses. During the three and nine months ended September 30, 2021, we incurred $2.1 million and $4.7 million, respectively, of these charges, which are included on the unaudited interim condensed consolidated statements of operations as a selling, general, and administrative expense. There were no comparable expenses in 2020.

SUBSEQUENT EVENT

9 Months Ended

Sep. 30, 2021

SUBSEQUENT EVENT

SUBSEQUENT EVENT

14. SUBSEQUENT EVENT

On October 29, 2021, the FDA approved the Company’s Supplemental New Drug Application (“sNDA”) for Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) (Cortrophin Gel) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (“MS”) and rheumatoid arthritis (“RA”), in addition to excess urinary protein due to nephrotic syndrome. Cortrophin Gel is an adrenocorticotropic hormone (“ACTH”), also known as purified corticotropin.

BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS (Policies)

9 Months Ended

Sep. 30, 2021

BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS

Organization and Business

Overview

Basis of Presentation

Principles of Consolidation

Foreign Currency

Use of Estimates

Geographic Information

The following table depicts the Company’s revenue by geographic operations during the following periods:


(in thousands)	Three Months Ended September 30,				Nine Months Ended September 30,
Location of Operations	2021		2020		2021		2020
United States	$	51,100	$	52,094	$	152,007	$	146,602
Canada		961		885		3,200		4,621
Total Revenue	$	52,061	$	52,979	$	155,207	$	151,223

The following table depicts the Company’s property and equipment, net according to geographic location as of:


(in thousands)	September 30, 2021		December 31, 2020
United States	$	25,512	$	26,960
Canada		14,014		14,309
Total property and equipment, net	$	39,526	$	41,269

Recent Accounting Pronouncements

Recent Accounting Pronouncements Not Yet Adopted

Recently Adopted Accounting Pronouncements

- Definition

Disclosure of accounting policy for segment reporting.

+ References + Details

BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS (Tables)

9 Months Ended

Sep. 30, 2021

BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS

Schedule of revenue from company's revenue by geographic operations

The following table depicts the Company’s revenue by geographic operations during the following periods:


(in thousands)	Three Months Ended September 30,				Nine Months Ended September 30,
Location of Operations	2021		2020		2021		2020
United States	$	51,100	$	52,094	$	152,007	$	146,602
Canada		961		885		3,200		4,621
Total Revenue	$	52,061	$	52,979	$	155,207	$	151,223

Schedule of company's property and equipment, net according to geographic location

The following table depicts the Company’s property and equipment, net according to geographic location as of:


(in thousands)	September 30, 2021		December 31, 2020
United States	$	25,512	$	26,960
Canada		14,014		14,309
Total property and equipment, net	$	39,526	$	41,269

REVENUE RECOGNITION AND RELATED ALLOWANCES (Tables)

9 Months Ended

Sep. 30, 2021

REVENUE RECOGNITION AND RELATED ALLOWANCES

Schedule of disaggregation of revenue and revenue recognized


	Three Months Ended				Nine Months Ended
Products and Services	September 30,		September 30,		September 30,		September 30,
(in thousands)	2021		2020		2021		2020
Sales of generic pharmaceutical products	$	35,140	$	37,712	$	101,952	$	108,607
Sales of branded pharmaceutical products		14,313		12,411		32,868		32,201
Sales of contract manufactured products		2,382		2,152		7,277		7,026
Royalties from licensing agreements		—		339		11,210		1,120
Product development services		77		289		332		1,751
Other		149		76		1,568		518
Total net revenues	$	52,061	$	52,979	$	155,207	$	151,223


	Three Months Ended				Nine Months Ended
Timing of Revenue Recognition	September 30,		September 30,		September 30,		September 30,
(in thousands)	2021		2020		2021		2020
Performance obligations transferred at a point in time	$	51,984	$	52,690	$	154,875	$	149,472
Performance obligations transferred over time		77		289		332		1,751
Total	$	52,061	$	52,979	$	155,207	$	151,223

Schedule of accruals and allowances

The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the nine months ended September 30, 2021 and 2020, respectively:


	Accruals for Chargebacks, Returns, and Other Allowances
							Administrative		Prompt
			Government				Fees and Other		Payment
(in thousands)	Chargebacks		Rebates		Returns		Rebates		Discounts
Balance at December 31, 2019 (1)	$	49,882	$	8,901	$	16,595	$	8,281	$	2,549
Accruals/Adjustments		288,538		14,288		22,744		27,383		10,248
Credits Taken Against Reserve		(262,531)		(11,511)		(16,089)		(27,287)		(9,442)
Balance at September 30, 2020 (1)	$	75,889	$	11,678	$	23,250	$	8,377	$	3,355

Balance at December 31, 2020 (1)	$	88,746	$	7,826	$	27,155	$	8,906	$	3,839
Accruals/Adjustments		343,117		31,515		16,043		74,594		31,138
Credits Taken Against Reserve		(333,867)		(27,628)		(10,969)		(75,877)		(30,876)
Balance at September 30, 2021 (1)	$	97,996	$	11,713	$	32,229	$	7,623	$	4,101

(1)

Schedule of customer concentration


	Three Months Ended				Nine Months Ended
	September 30,		September 30,		September 30,		September 30,
	2021		2020		2021		2020
Customer 1	31	%	30	%	29	%	31	%
Customer 2	23	%	25	%	22	%	24	%
Customer 3	17	%	19	%	15	%	19	%

INDEBTEDNESS (Tables)

9 Months Ended

Sep. 30, 2021

INDEBTEDNESS

Schedule of carrying value of the current and non-current components of the term loan

The carrying value of the current and non-current components of the Term Loan and DDTL as of September 30, 2021 and December 31, 2020 are:


	Current
	September 30,		December 31,
(in thousands)	2021		2020
Current borrowing on debt	$	16,355	$	13,691
Deferred financing costs		(428)		(448)
Current debt, net of deferred financing costs	$	15,927	$	13,243


	Non-Current
	September 30,		December 31,
(in thousands)	2021		2020
Non-current borrowing on debt	$	155,057	$	165,755
Deferred financing costs		(494)		(812)
Non-current debt, net of deferred financing costs and current component	$	154,563	$	164,943

Schedule of contractual maturity of term loan and DDTL

The contractual maturity of our Term Loan, DDTL, and Revolver is as follows for the years ending December 31:


(in thousands)	Term Loan		DDTL		Revolver
2021	$	2,707	$	2,950	$	—
2022		5,414		8,850		—
2023		54,141		97,350		31,500
Total	$	62,262	$	109,150	$	31,500

Schedule of components of total interest expense related to the notes and term loan


	Three Months Ended				Nine Months Ended
	September 30,		September 30,		September 30,		September 30,
(in thousands)	2021		2020		2021		2020
Contractual coupon	$	2,342	$	2,351	$	7,032	$	6,450
Amortization of finance fees		175		180		527		542
Capitalized interest		(17)		(18)		(74)		(67)
	$	2,500	$	2,513	$	7,485	$	6,925

- Definition

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

+ References

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+ Details

EARNINGS (LOSS) PER SHARE (Tables)

9 Months Ended

Sep. 30, 2021

EARNINGS (LOSS) PER SHARE

Schedule of Earnings per share, basic and diluted

Earnings (loss) per share for the three and nine months ended September 30, 2021 and 2020 are calculated for basic and diluted earnings (loss) per share as follows:


	Basic				Diluted				Basic				Diluted
(in thousands, except per share amounts)	Three Months Ended September 30,				Three Months Ended September 30,				Nine Months Ended September 30,				Nine Months Ended September 30,
	2021		2020		2021		2020		2021		2020		2021		2020
Net (loss)/income	$	(4,447)	$	434	$	(4,447)	$	434	$	(18,467)	$	(18,913)	$	(18,467)	$	(18,913)
Net income allocated to restricted stock		—		(12)		—		(13)		—		—		—		—
Net (loss)/income allocated to common shares	$	(4,447)	$	422	$	(4,447)	$	421	$	(18,467)	$	(18,913)	$	(18,467)	$	(18,913)
Basic Weighted-Average Shares Outstanding		12,107		11,991		12,107		11,991		12,066		11,953		12,066		11,953
Dilutive effect of stock options and ESPP						—		12						—		—
Diluted Weighted-Average Shares Outstanding						12,107		12,003						12,066		11,953

(Loss)/Income per share	$	(0.37)	$	0.04	$	(0.37)	$	0.04	$	(1.53)	$	(1.58)	$	(1.53)	$	(1.58)

INVENTORIES (Tables)

9 Months Ended

Sep. 30, 2021

INVENTORIES

Schedule of Inventories

Inventories consist of the following as of:


	September 30,		December 31,
(in thousands)	2021		2020
Raw materials	$	33,995	$	41,591
Packaging materials		3,631		3,194
Work-in-progress		814		886
Finished goods		28,460		20,363
		66,900		66,034
Reserve for excess/obsolete inventories		(5,216)		(5,231)
Inventories, net	$	61,684	$	60,803

GOODWILL AND INTANGIBLE ASSETS (Tables)

9 Months Ended

Sep. 30, 2021

GOODWILL AND INTANGIBLE ASSETS

Schedule of components of net definite-lived intangible assets

The components of net definite-lived intangible assets are as follows:


	September 30, 2021				December 31, 2020				Weighted Average
	Gross Carrying		Accumulated		Gross Carrying		Accumulated		Amortization
(in thousands)	Amount		Amortization		Amount		Amortization		Period
Acquired ANDA intangible assets	$	106,415	$	(51,684)	$	106,415	$	(42,367)	8.8	years
NDAs and product rights		242,372		(132,146)		230,974		(112,483)	9.9	years
Marketing and distribution rights		17,157		(12,107)		17,157		(11,386)	5.7	years
Non-compete agreement		624		(490)		624		(423)	7.0	years
	$	366,568	$	(196,427)	$	355,170	$	(166,659)	9.4	years

Schedule of expected future amortization expense

Expected future amortization expense is as follows:


(in thousands)
2021	$	10,057
2022		36,828
2023		36,080
2024		33,103
2025		29,755
2026 and thereafter		24,318
Total	$	170,141

STOCK-BASED COMPENSATION (Tables)

9 Months Ended

Sep. 30, 2021

Summary of Stock option and restricted stock activity

A summary of stock option and restricted stock activity under the 2008 Plan and Inducement Grants during the nine months ended September 30, 2021 and 2020 is presented below:


(in thousands)	Options	Inducement Grants	RSAs
Outstanding at December 31, 2019	757	—	192
Granted	42	180	305
Options Exercised/RSAs Vested	(8)	—	(128)	⁽¹⁾
Forfeited	(44)	—	(17)
Expired	—	—	—
Outstanding at September 30, 2020	747	180	352

Outstanding at December 31, 2020	756	180	352
Granted	97	61	463
Options Exercised/RSAs Vested	(5)	—	(126)	⁽²⁾
Forfeited	(74)	—	(61)
Expired	—	—	—
Outstanding at September 30, 2021	774	241	628

(1)

(2)

Employee Stock Purchase Plan 2016 [Member]

Summary of allocated expense


(in thousands)	Three Months Ended September 30,				Nine Months Ended September 30,
	2021		2020		2021		2020
Cost of sales	$	3	$	3	$	11	$	14
Research and development		5		6		16		25
Selling, general, and administrative		20		23		66		79
	$	28	$	32	$	93	$	118

Stock Incentive Plan 2008 [Member]

Summary of allocated expense


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2021		2020		2021		2020
Cost of sales	$	2	$	34	$	4	$	93
Research and development		144		117		407		450
Selling, general, and administrative		2,634		2,200		7,017		9,882
	$	2,780	$	2,351	$	7,428	$	10,425

COMMITMENTS AND CONTINGENCIES (Tables)

9 Months Ended

Sep. 30, 2021

COMMITMENTS AND CONTINGENCIES

Schedule of rent expense


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2021		2020		2021		2020
Operating lease costs	$	40	$	57	$	132	$	166
Variable lease costs		9		15		30		44
Total lease costs	$	49	$	72	$	162	$	210

Schedule of maturity analysis of operating leases


(in thousands)
Future payments:
2021	$	35
2022		127
2023		82
2024		56
2025 and thereafter		42
Total	$	342

Discount		(22)
Lease liability		320
Current lease liability		(130)
Non-current lease liability	$	190

FAIR VALUE DISCLOSURES (Tables)

9 Months Ended

Sep. 30, 2021

FAIR VALUE DISCLOSURES

Schedule of financial assets and liabilities accounted for at fair value on a recurring basis


(in thousands)	Fair Value at
Description	September 30, 2021		Level 1		Level 2		Level 3
Liabilities
Interest rate swaps	$	7,926	$	—	$	7,926	$	—
CVRs	$	—	$	—	$	—	$	—


	Fair Value at
Description	December 31, 2020		Level 1		Level 2		Level 3
Liabilities
Interest rate swaps	$	14,109	$	—	$	14,109	$	—
CVRs	$	—	$	—	$	—	$	—

BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS - Geographic (Details) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021 USD ($)	Sep. 30, 2020 USD ($)	Sep. 30, 2021 USD ($) segment	Sep. 30, 2020 USD ($)	Dec. 31, 2020 USD ($)
Number of segments \| segment			1
Revenue recognition	$ 52,061	$ 52,979	$ 155,207	$ 151,223
Property and equipment, net	39,526		39,526		$ 41,269
United States [Member]
Revenue recognition	51,100	52,094	152,007	146,602
Property and equipment, net	25,512		25,512		26,960
Canada [Member]
Revenue recognition	961	$ 885	3,200	$ 4,621
Property and equipment, net	$ 14,014		$ 14,014		$ 14,309

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8906-108599

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 40
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9031-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 41
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9038-108599

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 4
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130543-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 42
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e9054-108599

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 5
-URI http://asc.fasb.org/extlink&oid=121604090&loc=SL49130545-203045

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 924
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-URI http://asc.fasb.org/extlink&oid=6472922&loc=d3e499488-122856

+ Details

REVENUE RECOGNITION AND RELATED ALLOWANCES - Disaggregation (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Revenue recognition	$ 52,061	$ 52,979	$ 155,207	$ 151,223
Sales of generic pharmaceutical products [Member]
Revenue recognition	35,140	37,712	101,952	108,607
Sales of branded pharmaceutical products [Member]
Revenue recognition	14,313	12,411	32,868	32,201
Sales of contract manufactured products [Member]
Revenue recognition	2,382	2,152	7,277	7,026
Royalties from licensing agreements [Member]
Revenue recognition		339	11,210	1,120
Product development services [Member]
Revenue recognition	77	289	332	1,751
Other [Member]
Revenue recognition	$ 149	$ 76	$ 1,568	$ 518

- Definition

+ References

+ Details

REVENUE RECOGNITION AND RELATED ALLOWANCES - Timing (Details) - USD ($) $ in Thousands	3 Months Ended			9 Months Ended
	Sep. 30, 2021	Mar. 31, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Revenue recognition	$ 52,061		$ 52,979	$ 155,207	$ 151,223
Performance obligations satisfied in prior periods				11,000	(8,700)
Deferred revenue	62			62		$ 80
Revenue recognized			100		300
Performance obligations transferred at a point in time [Member]
Revenue recognition	51,984		52,690	154,875	149,472
Performance obligations transferred over time [Member]
Revenue recognition	77		$ 289	332	$ 1,751
Maximum
Revenue recognized	$ 100			100
Tripartite Agreement-Yescart
Revenue recognition		$ 11,200		$ 11,200

- Definition

+ References

+ Details

REVENUE RECOGNITION AND RELATED ALLOWANCES - Allowances (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Accruals and allowances
Beginning balance	$ 100,328
Ending balance	108,456
Chargebacks
Accruals and allowances
Beginning balance	88,746	$ 49,882
Accruals/Adjustments	343,117	288,538
Credits Taken Against Reserve	(333,867)	(262,531)
Ending balance	97,996	75,889
Government Rebates
Accruals and allowances
Beginning balance	7,826	8,901
Accruals/Adjustments	31,515	14,288
Credits Taken Against Reserve	(27,628)	(11,511)
Ending balance	11,713	11,678
Returns
Accruals and allowances
Beginning balance	27,155	16,595
Accruals/Adjustments	16,043	22,744
Credits Taken Against Reserve	(10,969)	(16,089)
Ending balance	32,229	23,250
Administrative Fees and Other Rebates
Accruals and allowances
Beginning balance	8,906	8,281
Accruals/Adjustments	74,594	27,383
Credits Taken Against Reserve	(75,877)	(27,287)
Ending balance	7,623	8,377
Prompt Payment Discounts
Accruals and allowances
Beginning balance	3,839	2,549
Accruals/Adjustments	31,138	10,248
Credits Taken Against Reserve	(30,876)	(9,442)
Ending balance	$ 4,101	$ 3,355

REVENUE RECOGNITION AND RELATED ALLOWANCES - Concentration (Details) $ in Thousands	3 Months Ended			9 Months Ended
	Sep. 30, 2021 USD ($) customer	Mar. 31, 2021 USD ($)	Sep. 30, 2020 USD ($) customer	Sep. 30, 2021 USD ($) customer	Sep. 30, 2020 USD ($) customer
Revenue recognition	$ 52,061		$ 52,979	$ 155,207	$ 151,223
Tripartite Agreement-Yescart
Revenue recognition		$ 11,200		11,200
Payment for legal expenditures		$ 400
Sales of contract manufactured products [Member]
Revenue, Remaining Performance Obligation, Amount	$ 3,000			$ 3,000
Revenue, Remaining Performance Obligation, Remaining Period	6 months			6 months
Revenue recognition	$ 2,382		$ 2,152	$ 7,277	$ 7,026
Product Development Services [Member]
Revenue, Remaining Performance Obligation, Amount	$ 400			$ 400
Revenue, Remaining Performance Obligation, Remaining Period	6 months			6 months
Customer concentration \| Revenue \| Customer One [Member]
Concentration Risk, Percentage	0.31%		0.30%	0.29%	0.31%
Customer concentration \| Revenue \| Customer Two [Member]
Concentration Risk, Percentage	0.23%		0.25%	0.22%	0.24%
Customer concentration \| Revenue \| Customer Three [Member]
Concentration Risk, Percentage	0.17%		0.19%	0.15%	0.19%
Customer concentration \| Accounts receivable \| Three Customers [Member]
Number of major customers \| customer	3		3	3	3
Concentration Risk, Percentage				85.00%

PENDING BUSINESS COMBINATION (Details) - USD ($) $ / shares in Units, $ in Millions			3 Months Ended	9 Months Ended
	May 24, 2021	Mar. 08, 2021	Sep. 30, 2021	Sep. 30, 2021
PIPE Investment [Member]
Business Acquisition [Line Items]
Share price (in dollars per share)		$ 1,000
Stock issued, value		$ 25.0
Stock issued (in shares)		25,000
Senior Secured Credit Facility 2021 [Member] \| Term Loan [Member]
Business Acquisition [Line Items]
Maximum borrowing capacity	$ 300.0
Senior Secured Credit Facility 2021 [Member] \| Term Loan [Member] \| LIBOR [Member]
Business Acquisition [Line Items]
Basis spread (as a percent)	6.00%
Senior Secured Credit Facility 2021 [Member] \| Term Loan [Member] \| Alternative Base Rate [Member]
Business Acquisition [Line Items]
Basis spread (as a percent)	5.00%
Senior Secured Credit Facility 2021 [Member] \| Revolver [Member]
Business Acquisition [Line Items]
Maximum borrowing capacity	$ 40.0
Commitment fee (as a percent)	0.50%
Senior Secured Credit Facility 2021 [Member] \| Revolver [Member] \| LIBOR [Member]
Business Acquisition [Line Items]
Basis spread (as a percent)	4.75%
Senior Secured Credit Facility 2021 [Member] \| Revolver [Member] \| Alternative Base Rate [Member]
Business Acquisition [Line Items]
Basis spread (as a percent)	3.75%
Novitium Pharma [Member]
Business Acquisition [Line Items]
Cash outflow in merger		$ 89.5
Equity issued in merger, value		$ 74.0
Equity issued in merger (in shares)		2,466,667
Contingent consideration		$ 46.5
Share price (in dollars per share)		$ 30.00
Transaction costs			$ 0.5	$ 5.1
Novitium Pharma [Member] \| Senior Secured Credit Facility 2021 [Member]
Business Acquisition [Line Items]
Acquisition debt incurred		$ 340.0
Ticking fees			$ 2.4	$ 2.4
Novitium Pharma [Member] \| Senior Secured Credit Facility 2021 [Member] \| Term Loan [Member]
Business Acquisition [Line Items]
Acquisition debt incurred		300.0
Novitium Pharma [Member] \| Senior Secured Credit Facility 2021 [Member] \| Revolver [Member]
Business Acquisition [Line Items]
Acquisition debt incurred		$ 40.0

INDEBTEDNESS - Credit facility (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Current debt	$ 15,927		$ 13,243
Borrowing repayment	$ 0	$ 7,500
Senior Secured Credit Facility [Member]
Debt Instrument, Term	5 years
Commitment fee (as a percent)	0.40%
Senior Secured Credit Facility [Member] \| LIBOR [Member]
Basis spread (as a percent)	2.00%
Senior Secured Credit Facility [Member] \| LIBOR [Member] \| Minimum
Basis spread (as a percent)	1.50%
Senior Secured Credit Facility [Member] \| LIBOR [Member] \| Maximum
Basis spread (as a percent)	2.75%
Senior Secured Credit Facility [Member] \| Alternative Base Rate [Member] \| Minimum
Basis spread (as a percent)	0.50%
Senior Secured Credit Facility [Member] \| Alternative Base Rate [Member] \| Maximum
Basis spread (as a percent)	1.75%
Senior Secured Credit Facility [Member] \| Term Loan [Member]
Maximum borrowing capacity	$ 72,200
Quarterly payment	6,800
Current debt	6,800
Senior Secured Credit Facility [Member] \| Delayed Draw Term Loan [Member]
Maximum borrowing capacity	118,000
Quarterly payment	9,600
Current debt	9,600
Senior Secured Credit Facility [Member] \| Revolver [Member]
Maximum borrowing capacity	75,000
Amount borrowed	31,500
Remaining borrowing capacity	$ 43,500
Senior Secured Credit Facility [Member] \| Revolver [Member] \| Minimum
Commitment fee (as a percent)	0.25%
Senior Secured Credit Facility [Member] \| Revolver [Member] \| Maximum
Commitment fee (as a percent)	0.50%

INDEBTEDNESS - Facility components (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Current debt, net of deferred financing costs	$ 15,927	$ 13,243
Non-current debt, net of deferred financing costs and current component	186,063	172,443
Term Loan and DDTL [Member]
Current borrowing on debt	16,355	13,691
Deferred financing costs	(428)	(448)
Current debt, net of deferred financing costs	15,927	13,243
Non-current borrowing on debt	155,057	165,755
Deferred financing costs	(494)	(812)
Non-current debt, net of deferred financing costs and current component	$ 154,563	$ 164,943

INDEBTEDNESS - Outstanding (Details) - Senior Secured Credit Facility [Member] $ in Millions	Sep. 30, 2021 USD ($)
Term Loan [Member]
Borrowing on debt	$ 62.3
Delayed Draw Term Loan [Member]
Borrowing on debt	109.2
Revolver [Member]
Borrowing on debt	31.5
Total debt issuance costs, net	0.6
Debt issuance costs, noncurrent	0.3
Debt issuance costs, current	$ 0.3

INDEBTEDNESS - Credit facility - Maturity (Details) $ in Thousands	Sep. 30, 2021 USD ($)
Term Loan [Member]
2021	$ 2,707
2022	5,414
2023	54,141
Total	62,262
Delayed Draw Term Loan [Member]
2021	2,950
2022	8,850
2023	97,350
Total	109,150
Revolver [Member]
2023	31,500
Total	$ 31,500

INDEBTEDNESS - Interest (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
INDEBTEDNESS - Interest (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
INDEBTEDNESS
Contractual coupon	$ 2,342	$ 2,351	$ 7,032	$ 6,450
Amortization of finance fees	175	180	527	542
Capitalized interest	(17)	(18)	(74)	(67)
Interest Expense, Debt	$ 2,500	$ 2,513	$ 7,485	$ 6,925

DERIVATIVE FINANCIAL INSTRUMENT AND HEDGING ACTIVITY (Details) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2021	Dec. 31, 2020	Apr. 30, 2020	Feb. 28, 2019
Accumulated other comprehensive loss, net of tax	$ 4,235	$ 4,235	$ 11,437
Fair value interest rate derivative liabilities	7,926	7,926	$ 14,109
Interest rate swap [Member]
Derivative liability, notional amount				$ 184,200
Accumulated other comprehensive loss, net of tax	4,200	4,200
Fair value interest rate derivative liabilities	7,900	7,900
Unrealized gain (loss)	600	4,700
Change in the derivative fair value, tax	300	200
Interest expense	1,300	3,700
Interest rate swap [Member] \| Term Loan [Member]
Weighted average fixed rate (as a percent)					2.60%
Interest rate swap [Member] \| Delayed Draw Term Loan [Member]
Weighted average fixed rate (as a percent)					2.47%
Interest rate swap [Member] \| Senior Secured Credit Facility [Member]
Derivative liability, notional amount	$ 171,400	$ 171,400
Debt effective interest rate (as a percent)	1.99%	1.99%
Fair value interest rate derivative liabilities	$ 7,900	$ 7,900

EARNINGS (LOSS) PER SHARE (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
EARNINGS (LOSS) PER SHARE
Net (loss)/income	$ (4,447)	$ 434	$ (18,467)	$ (18,913)
Net income allocated to restricted stock, Basic		(12)
Net income allocated to restricted stock, Diluted		(13)
Net (loss)/income allocated to common shares, Basic	(4,447)	422	(18,467)	(18,913)
Net (loss)/income allocated to common shares, Diluted	$ (4,447)	$ 421	$ (18,467)	$ (18,913)
Basic Weighted-Average Shares Outstanding	12,107	11,991	12,066	11,953
Dilutive effect of stock options and ESPP		12
Diluted Weighted-Average Shares Outstanding	12,107	12,003	12,066	11,953
(Loss)/Income per share, Basic	$ (0.37)	$ 0.04	$ (1.53)	$ (1.58)
(Loss)/Income per share, Diluted	$ (0.37)	$ 0.04	$ (1.53)	$ (1.58)

EARNINGS (LOSS) PER SHARE - Additional information (Details) - shares shares in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
EARNINGS (LOSS) PER SHARE
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	1.6	1.1	1.7	1.3

INVENTORIES (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
INVENTORIES
Raw materials	$ 33,995	$ 41,591
Packaging materials	3,631	3,194
Work-in-progress	814	886
Finished goods	28,460	20,363
Inventory, Gross, Total	66,900	66,034
Reserve for excess/obsolete inventories	(5,216)	(5,231)
Inventories, net	$ 61,684	$ 60,803

INVENTORIES - Concentration (Details) - Supplier concentration - Cost of goods sold - One supplier - item	3 Months Ended	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2020
Concentration Risk, Percentage	14.00%	12.00%
Number of major suppliers	1	1

GOODWILL AND INTANGIBLE ASSETS - Goodwill (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2018	Dec. 31, 2020	Dec. 31, 2013
Goodwill	$ 3,580		$ 3,580			$ 3,580
Goodwill, impairment loss	$ 0	$ 0	$ 0	$ 0
BioSante Pharmaceuticals Inc [Member]
Goodwill							$ 1,800
WellSpring Pharma Services [Member]
Acquisition of WellSpring					$ 1,700

GOODWILL AND INTANGIBLE ASSETS - Components (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
INTANGIBLE ASSETS
Gross Carrying Amount	$ 366,568		$ 366,568		$ 355,170
Accumulated Amortization	(196,427)		(196,427)		$ (166,659)
Weighted Average Amortization Period					9 years 4 months 24 days
Amortization of intangible assets	10,100	$ 10,100	29,800	$ 30,200
Intangible asset impairment charge	0	$ 0	0	$ 0
Acquired ANDA intangible assets
INTANGIBLE ASSETS
Gross Carrying Amount	106,415		106,415		$ 106,415
Accumulated Amortization	(51,684)		$ (51,684)		(42,367)
Weighted Average Amortization Period			8 years 9 months 18 days
NDAs and product rights
INTANGIBLE ASSETS
Gross Carrying Amount	242,372		$ 242,372		230,974
Accumulated Amortization	(132,146)		$ (132,146)		(112,483)
Weighted Average Amortization Period			9 years 10 months 24 days
Marketing and distribution rights
INTANGIBLE ASSETS
Gross Carrying Amount	17,157		$ 17,157		17,157
Accumulated Amortization	(12,107)		$ (12,107)		(11,386)
Weighted Average Amortization Period			5 years 8 months 12 days
Non-compete agreement
INTANGIBLE ASSETS
Gross Carrying Amount	624		$ 624		624
Accumulated Amortization	$ (490)		$ (490)		$ (423)
Weighted Average Amortization Period			7 years

GOODWILL AND INTANGIBLE ASSETS - Amortization (Details) $ in Thousands	Sep. 30, 2021 USD ($)
GOODWILL AND INTANGIBLE ASSETS
2021	$ 10,057
2022	36,828
2023	36,080
2024	33,103
2025	29,755
2026 and thereafter	24,318
Total	$ 170,141

STOCK-BASED COMPENSATION - Expense (Details) - USD ($) $ in Thousands, shares in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Employee Stock Purchase Plan 2016 [Member]
Discount from market price (as a percent)			15.00%
Allocated share-based compensation expense	$ 28	$ 32	$ 93	$ 118
Stock-based compensation shares available	0.2		0.2
Stock Incentive Plan 2008 [Member]
Allocated share-based compensation expense	$ 2,780	2,351	$ 7,428	10,425
Stock-based compensation shares available	0.6		0.6
Cost of sales [Member] \| Employee Stock Purchase Plan 2016 [Member]
Allocated share-based compensation expense	$ 3	3	$ 11	14
Cost of sales [Member] \| Stock Incentive Plan 2008 [Member]
Allocated share-based compensation expense	2	34	4	93
Research and development Expense [Member] \| Employee Stock Purchase Plan 2016 [Member]
Allocated share-based compensation expense	5	6	16	25
Research and development Expense [Member] \| Stock Incentive Plan 2008 [Member]
Allocated share-based compensation expense	144	117	407	450
Selling, general and administrative Expenses [Member] \| Employee Stock Purchase Plan 2016 [Member]
Allocated share-based compensation expense	20	23	66	79
Selling, general and administrative Expenses [Member] \| Stock Incentive Plan 2008 [Member]
Allocated share-based compensation expense	$ 2,634	$ 2,200	$ 7,017	$ 9,882

STOCK-BASED COMPENSATION - Stock option activity (Details) - shares shares in Thousands	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Options [Member]
Option Shares
Outstanding at the beginning of the period (in shares)	756	757
Granted (in shares)	97	42
Exercised (in shares)	(5)	(8)
Forfeited (in shares)	(74)	(44)
Outstanding at the end of the period (in shares)	774	747
Inducement Grants [Member]
Option Shares
Outstanding at the beginning of the period (in shares)	180
Granted (in shares)	61	180
Outstanding at the end of the period (in shares)	241	180

STOCK-BASED COMPENSATION - RSA activity (Details) - Restricted Stock [Member] - shares shares in Thousands	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Unvested, Shares, Outstanding, Beginning of period	352	192
Unvested Shares, Granted	463	305
Unvested Shares, Vested	(126)	(128)
Unvested Shares, Forfeited	(61)	(17)
Unvested Shares, Outstanding, End of period	628	352

STOCK-BASED COMPENSATION - Additional information (Details) - USD ($) shares in Thousands, $ in Thousands	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Treasury stock value	$ 3,135		$ 2,246
Restricted Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares purchased from employees	28	43
Treasury stock value	$ 900	$ 1,500

INCOME TAXES - Quarter (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
INCOME TAXES - Quarter (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
INCOME TAXES
Valuation allowance	$ 400		$ 400
Provision (benefit) for income taxes	$ (2,683)	$ (371)	$ (6,738)	$ (4,667)
Effective income tax rate (as a percent)	37.60%	19.80%	26.70%	19.80%
Pre-tax consolidated loss	$ (7,130)	$ 63	$ (25,205)	$ (23,580)

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
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-Subparagraph (c)
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 30
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8906-108599

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 32
-Subparagraph (f)
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8933-108599

Reference 4: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 940
-SubTopic 20
-Section 25
-Paragraph 1
-URI http://asc.fasb.org/extlink&oid=68072869&loc=d3e41242-110953

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
-Paragraph 22
-URI http://asc.fasb.org/extlink&oid=120311839&loc=d3e8736-108599

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(10))
-URI http://asc.fasb.org/extlink&oid=120395209&loc=SL114868664-224227

Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 944
-SubTopic 220
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(8))
-URI http://asc.fasb.org/extlink&oid=120400993&loc=SL114874131-224263

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 235
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-05(b)(2))
-URI http://asc.fasb.org/extlink&oid=120399901&loc=d3e537907-122884

Reference 9: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
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-Section 50
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Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
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-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(15))
-URI http://asc.fasb.org/extlink&oid=120399700&loc=SL114874048-224260

+ Details

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

COMMITMENTS AND CONTINGENCIES - Leases expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Operating lease, weighted average remaining lease term	2 years 6 months		2 years 6 months
Operating lease costs	$ 40	$ 57	$ 132	$ 166
Variable lease costs	9	15	30	44
Total lease costs	$ 49	$ 72	$ 162	$ 210
Minimum
Operating lease liability discount rates (in percent)	3.99%		3.99%
Maximum
Operating lease liability discount rates (in percent)	8.95%		8.95%

COMMITMENTS AND CONTINGENCIES - Lease maturity (Details) $ in Thousands	Sep. 30, 2021 USD ($)
COMMITMENTS AND CONTINGENCIES
2021	$ 35
2022	127
2023	82
2024	56
2025 and thereafter	42
Total	342
Discount	(22)
Lease liability	320
Current lease liability	$ (130)
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Accrued Liabilities, Current
Non-current lease liability	$ 190
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List]	Other Liabilities, Noncurrent

COMMITMENTS AND CONTINGENCIES (Details) - USD ($) $ in Thousands		3 Months Ended		9 Months Ended
	Aug. 03, 2021	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
COMMITMENTS AND CONTINGENCIES
Revenue recognition		$ 52,061	$ 52,979	$ 155,207	$ 151,223
Settlement amount awarded to other party	$ 8,400
Unapproved Products [Member]
COMMITMENTS AND CONTINGENCIES
Revenue recognition		4,200	4,300	12,200	12,400
Unapproved Products [Member] \| Contract Customer [Member]
COMMITMENTS AND CONTINGENCIES
Revenue recognition		$ 700	$ 700	$ 2,100	$ 2,300

- Definition

+ References

+ Details

FAIR VALUE DISCLOSURES (Details) - USD ($) $ in Thousands	9 Months Ended
FAIR VALUE DISCLOSURES (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020	Apr. 30, 2020
Interest rate swaps	$ 7,926		$ 14,109
Asset impairment charge	0	$ 104
Fair Value, Inputs, Level 2 [Member]
Interest rate swaps	7,926		$ 14,109
Senior Secured Credit Facility [Member] \| Term Loan [Member]
Long-term debt, gross	62,300
Senior Secured Credit Facility [Member] \| Delayed Draw Term Loan [Member]
Long-term debt, gross	$ 109,200
Contingent Value Rights [Member] \| Discount rate
Fair values inputs discount rate	15.00%
Interest rate swap [Member]
Interest rate swaps	$ 7,900
Derivative liability, notional amount				$ 184,200
Interest rate swap [Member] \| Senior Secured Credit Facility [Member]
Interest rate swaps	7,900
Derivative liability, notional amount	$ 171,400

FAIR VALUE DISCLOSURES - Acquired (Details) $ in Thousands	1 Months Ended			3 Months Ended			9 Months Ended		12 Months Ended
FAIR VALUE DISCLOSURES - Acquired (Details) $ in Thousands	Apr. 30, 2021 USD ($)	Jul. 31, 2020 USD ($)	Jan. 31, 2020 USD ($) product	Sep. 30, 2021 USD ($)	Sep. 30, 2020 USD ($)	Mar. 31, 2020 USD ($)	Sep. 30, 2021 USD ($)	Sep. 30, 2020 USD ($)	Dec. 31, 2020 USD ($)
Payments to acquire intangible assets							$ 21,069	$ 62,178
Gross carrying amount				$ 366,568			366,568		$ 355,170
Useful life of intangible assets									9 years 4 months 24 days
Research and development				2,456	$ 2,939		8,229	12,318
Intangible asset impairment charge				0	0		0	0
Amortization of intangible assets				10,100	$ 10,100		29,800	30,200
Inventories, net				61,684			61,684		$ 60,803
Raw materials				33,995			33,995		41,591
Finished goods				28,460			28,460		20,363
Acquired in-process research and development ("IPR&D")							0	$ 3,753
Acquired ANDA intangible assets
Gross carrying amount				106,415			$ 106,415		106,415
Useful life of intangible assets							8 years 9 months 18 days
Marketing and distribution rights
Gross carrying amount				$ 17,157			$ 17,157		$ 17,157
Useful life of intangible assets							5 years 8 months 12 days
Sandoz Inc [Member]
Total asset purchase	$ 20,700
Transaction costs	400
Gross carrying amount	$ 11,400
Useful life of intangible assets	7 years
Intangible asset impairment charge							$ 0
Inventories, net	$ 9,700
Raw materials	600
Sample inventory	1,000
Finished goods	$ 8,100
Sandoz Inc [Member] \| Discount rate
Fair values inputs discount rate	10.00%
Private Company [Member]
Total asset purchase		$ 4,300
Transaction costs		100
Gross carrying amount		$ 3,000
Useful life of intangible assets		7 years
Intangible asset impairment charge							0
Inventories, net		$ 1,400
Amerigen Pharmaceuticals, Ltd.
Number of generic products \| product			23
Total asset purchase			$ 56,800
Transaction costs			700
Contingent liability not recognized			$ 25,000
Period of contingent payments			4 years
Useful life of intangible assets			7 years
Research and development			$ 3,800
Intangible asset impairment charge							$ 0
Inventories, net			8,400
Raw materials			1,700
Finished goods			$ 6,700
Amerigen Pharmaceuticals, Ltd. \| Revolver [Member]
Proceeds from borrowing						$ 15,000
Amerigen Pharmaceuticals, Ltd. \| Discount rate
Fair values inputs discount rate			8.00%
Amerigen Pharmaceuticals, Ltd. \| Acquired ANDA intangible assets
Gross carrying amount			$ 38,500
Amerigen Pharmaceuticals, Ltd. \| Marketing and distribution rights
Gross carrying amount			$ 6,700

CORTROPHIN PRE-LAUNCH CHARGES (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Purified Cortrophin Gel pre-launch charges	$ 227	$ 37	$ 780	$ 8,275
Operating Expense [Member]
Purified Cortrophin Gel pre-launch charges	200	100	800	8,300
Selling, general and administrative Expenses [Member]
Purified Cortrophin Gel pre-launch charges	$ 2,100	$ 0	$ 4,700	$ 0