0001023024-22-000008 | 10-Q | XBRL Viewer

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Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2022	May 03, 2022
Document Information [Line Items]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2022
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	2022
Document Fiscal Period Focus	Q1
Amendment Flag	false
Common Stock
Document Information [Line Items]
Entity Common Stock, Shares Outstanding		17,235,965
Class C Special Stock
Document Information [Line Items]
Entity Common Stock, Shares Outstanding		10,864

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Current Assets
Cash and cash equivalents	$ 76,911	$ 100,300
Accounts receivable, net of $113,970 and $105,260 of adjustments for chargebacks and other allowances at March 31, 2022 and December 31, 2021, respectively	131,625	128,526
Inventories, net	83,155	81,693
Prepaid income taxes	1,982	3,667
Prepaid expenses and other current assets	7,726	7,589
Total Current Assets	301,399	321,775
Property and equipment	77,677	75,627
Accumulated depreciation	(24,964)	(22,956)
Property and equipment, net	52,713	52,671
Restricted cash	5,000	5,001
Deferred tax assets, net of deferred tax liabilities and valuation allowance	73,539	67,936
Intangible assets, net	281,573	294,122
Goodwill	28,188	27,888
Derivatives and other non-current assets	2,434	2,205
Total Assets	744,846	771,598
Current Liabilities
Current debt, net of deferred financing costs	850	850
Accounts payable	22,059	22,967
Accrued royalties	4,998	6,225
Accrued compensation and related expenses	3,265	8,522
Accrued government rebates	4,557	5,492
Returned goods reserve	35,554	35,831
Deferred revenue	116	87
Accrued expenses and other	8,133	7,563
Total Current Liabilities	79,532	87,537
Non-current Liabilities
Non-current debt, net of deferred financing costs and current component	286,307	286,520
Non-current contingent consideration	32,053	31,000
Derivatives and other non-current liabilities	860	7,801
Total Liabilities	398,752	412,858
Commitments and Contingencies (Note 12)
Mezzanine Equity
Convertible Preferred Stock, Series A, $0.0001 par value, 1,666,667 shares authorized; 25,000 shares issued and outstanding at March 31, 2022 and December 31, 2021	24,850	24,850
Stockholders' Equity
Common Stock, $0.0001 par value, 33,333,334 shares authorized; 17,373,730 shares issued and 17,251,022 outstanding at March 31, 2022; 16,912,401 shares issued and 16,829,739 shares outstanding at December 31, 2021	1	1
Class C Special Stock, $0.0001 par value, 781,281 shares authorized; 10,864 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively
Preferred Stock, $0.0001 par value, 1,666,667 shares authorized; 0 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively
Treasury stock, 122,708 shares of common stock, at cost, at March 31, 2022 and 82,662 shares of common stock, at cost, at December 31, 2021	(4,253)	(3,135)
Additional paid-in capital	391,084	387,844
Accumulated deficit	(68,300)	(47,765)
Accumulated other comprehensive income/(loss), net of tax	2,712	(3,055)
Total Stockholders' Equity	321,244	333,890
Total Liabilities, Mezzanine Equity, and Stockholders' Equity	$ 744,846	$ 771,598

Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Adjustments for chargebacks and other allowances	$ 113,970	$ 105,260
Preferred Stock, Par or Stated Value Per Share (in dollars per share)	$ 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	122,708	82,662
Convertible Preferred Stock
Convertible Preferred Stock, Par Value (in dollars per share)	$ 0.0001	$ 0.0001
Convertible Preferred Stock, Shares Authorized	1,666,667	1,666,667
Convertible Preferred Stock, Shares Issued	25,000	25,000
Convertible Preferred Stock, Shares Outstanding	25,000	25,000
Common Stock
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	17,373,730	16,912,401
Common Stock, Outstanding Shares	17,251,022	16,829,739
Class C Special Stock
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
	Mar. 31, 2022	Mar. 31, 2021
Condensed Consolidated Statements of Operations
Net Revenues	$ 64,477	$ 54,521
Operating Expenses
Cost of sales (excluding depreciation and amortization)	34,271	19,985
Research and development	5,274	2,968
Selling, general, and administrative	28,817	17,587
Depreciation and amortization	14,557	10,898
Contingent consideration fair value adjustment	753	0
Purified Cortrophin Gel pre-launch charges	0	38
Total Operating Expenses	83,672	51,476
Operating (Loss)/Income	(19,195)	3,045
Other Expense, net
Interest expense, net	(6,613)	(2,454)
Other expense, net	(89)	(515)
(Loss)/Income Before Benefit for Income Taxes	(25,897)	76
Benefit for income taxes	5,767	10
Net (Loss)/Income	(20,130)	86
Dividends on Series A convertible preferred stock	(405)	0
Net (Loss)/Income Available to Common Shareholders	$ (20,535)	$ 81
Basic and Diluted (Loss)/Earnings Per Share:
Basic (Loss)/Earnings Per Share	$ (1.27)	$ 0.01
Diluted (Loss)/Earnings Per Share	$ (1.27)	$ 0.01
Basic Weighted-Average Shares Outstanding	16,137	12,004
Diluted Weighted-Average Shares Outstanding	16,137	12,017

Condensed Consolidated Statements of Comprehensive Income(Loss) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Condensed Consolidated Statements of Comprehensive Income/(Loss)
Net (loss)/income	$ (20,130)	$ 86
Other comprehensive income/(loss), net of tax:
Gains on interest rate swap, net of tax	5,767	6,405
Total other comprehensive income/(loss), net of tax	5,767	6,405
Total comprehensive (loss)/income, net of tax	$ (14,363)	$ 6,491

- Definition

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

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- Definition

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

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Condensed Consolidated Statements of Changes in Mezzanine Equity and Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands	Common Stock	Class C Special Stock	Additional Paid-in Capital	Treasury Stock	Accumulated Other Comprehensive Gain/(Loss), Net of Tax	Accumulated Deficit	Total
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
Increase (decrease) in Stockholders' Equity
Stock-based Compensation Expense			1,869				1,869
Treasury Stock Purchases for Restricted Stock Vests				$ (348)			(348)
Treasury Stock Purchases for Restricted Stock Vests (in shares)				10
Issuance of Restricted Stock Awards (in shares)	438
Restricted Stock Awards Forfeitures (in shares)	(38)
Other Comprehensive Income					6,405		6,405
Net Loss (Income)						86	86
Balance at Mar. 31, 2021	$ 1		216,223	$ (2,594)	(5,032)	(4,886)	203,712
Balance (in shares) at Mar. 31, 2021	12,830			86
Increase (decrease) in Stockholders' Equity
Balance, permanent and temporary equity							358,740
Balance at Dec. 31, 2021	$ 1		387,844	$ (3,135)	(3,055)	(47,765)	333,890
Balance (in shares) at Dec. 31, 2021	16,913			83
Increase (decrease) in Stockholders' Equity
Stock-based Compensation Expense			3,237				3,237
Treasury Stock Purchases for Restricted Stock Vests				$ (1,118)			(1,118)
Treasury Stock Purchases for Restricted Stock Vests (in shares)				40
Issuance of Restricted Stock Awards	$ 0	$ 0	0	$ 0	0	0	0
Issuance of Restricted Stock Awards (in shares)	461
Issuance of Common Shares upon Stock Option and ESPP Exercise			3				3
Dividends on Series A Convertible Preferred Stock						(405)	(405)
Other Comprehensive Income					5,767		5,767
Net Loss (Income)						(20,130)	(20,130)
Balance at Mar. 31, 2022	$ 1		$ 391,084	$ (4,253)	$ 2,712	$ (68,300)	321,244
Balance (in shares) at Mar. 31, 2022	17,374			123
Increase (decrease) in Stockholders' Equity
Balance, permanent and temporary equity							$ 346,094

Consolidated Statements of Changes in Mezzanine Equity and Stockholders' Equity-Mezzanine - 3 months ended Mar. 31, 2022 - USD ($) $ in Thousands	Convertible Preferred Stock	Total
Balance at Dec. 31, 2021	$ 24,850	$ 24,850
Balance (in shares) at Dec. 31, 2021	25,000
Increase (decrease) in temporary equity
Issuance of Restricted Stock Awards	$ 0	0
Issuance of Restricted Stock Awards (in shares)	0
Balance at Mar. 31, 2022	$ 24,850	$ 24,850
Balance (in shares) at Mar. 31, 2022	25,000

- Definition

Carrying amount, attributable to parent, of an entity's issued and outstanding stock which is not included within permanent equity. Temporary equity is a security with redemption features that are outside the control of the issuer, is not classified as an asset or liability in conformity with GAAP, and is not mandatorily redeemable. Includes any type of security that is redeemable at a fixed or determinable price or on a fixed or determinable date or dates, is redeemable at the option of the holder, or has conditions for redemption which are not solely within the control of the issuer. Includes stock with a put option held by an ESOP and stock redeemable by a holder only in the event of a change in control of the issuer.

+ References + Details

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Cash Flows From Operating Activities
Net (loss)/income	$ (20,130)	$ 86
Adjustments to reconcile net (loss)/income to net cash and cash equivalents (used in)/provided by operating activities
Stock-based compensation	3,237	1,869
Deferred taxes	(7,464)	(279)
Depreciation and amortization	14,557	10,898
Non-cash interest	982	572
Contingent consideration fair value adjustment	753	0
Changes in operating assets and liabilities
Accounts receivable, net	(3,099)	3,917
Inventories, net	(1,462)	876
Prepaid expenses and other current assets	(137)	379
Accounts payable	(1,009)	2,462
Accrued royalties	(1,227)	(1,097)
Current income taxes payable, net	1,685	(247)
Accrued government rebates	(935)	846
Returned goods reserve	(248)	1,792
Accrued expenses, accrued compensation, and other	(4,445)	(1,406)
Net Cash and Cash Equivalents (Used in)/Provided by Operating Activities	(18,942)	20,668
Cash Flows From Investing Activities
Acquisition of product rights, IPR&D, and other related assets	(229)	(39)
Acquisition of property and equipment, net	(1,949)	(698)
Net Cash and Cash Equivalents Used in Investing Activities	(2,178)	(737)
Cash Flows From Financing Activities
Payments on borrowings under credit agreements	(750)	(2,377)
Series A convertible preferred stock dividends paid	(405)	0
Proceeds from stock option exercises and ESPP purchases	3	0
Treasury stock purchases for restricted stock vests	(1,118)	(348)
Net Cash and Cash Equivalents Used in by Financing Activities	(2,270)	(2,725)
Net Change in Cash and Cash Equivalents	(23,390)	17,206
Cash, cash equivalents, and restricted cash, beginning of period	105,301	12,867
Cash, cash equivalents, and restricted cash, end of period	81,911	30,073
Reconciliation of cash, cash equivalents, and restricted cash, beginning of period
Cash and cash equivalents	100,300	7,864
Restricted cash	5,001	5,003
Cash, cash equivalents, and restricted cash, beginning of period	105,301	12,867
Reconciliation of cash, cash equivalents, and restricted cash, end of period
Cash and cash equivalents	76,911	25,073
Restricted cash	5,000	5,000
Cash, cash equivalents, and restricted cash, end of period	81,911	30,073
Supplemental disclosure for cash flow information:
Cash paid for interest, net of amounts capitalized	5,637	1,983
Cash paid for income taxes	0	112
Supplemental non-cash investing and financing activities:
Debt issuance costs in accrued expenses	0	115
Acquisition of product rights, IPR&D, and other related assets included in returned goods reserve and derivatives and other non-current liabilities	0	388
Property and equipment purchased and included in accounts payable	$ 253	$ 218

BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS

3 Months Ended

Mar. 31, 2022

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 (together, “ANI,” the “Company,” “we,” “us,” or “our”) is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. Our four pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota, one is located in East Windsor, New Jersey, 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, 2021 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, 2021.

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 subsidiaries located in Canada and India. The Canada-based subsidiary conducts its transactions in U.S. dollars and Canadian dollars, but its functional currency is the U.S. dollar. The Indian-based subsidiary generally conducts its transactions in Indian rupees, which is also its functional currency. The results of any non-U.S. dollar transactions and balances 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 and the translation impact of local currencies to U.S. dollars was immaterial for the three months ended March 31, 2022 and 2021. 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 condensed consolidated financial statements, estimates are used for, but not limited to,

variable consideration determined based on accruals for chargebacks, administrative fees and rebates, government rebates, returns and other allowances, income tax provision or benefit, deferred taxes and valuation allowance, stock-based compensation, revenue recognition, allowance for inventory obsolescence, valuation of financial instruments and intangible assets, accruals for contingent liabilities, including contingent consideration in acquisitions, fair value of long-lived assets, determination of right-of-use assets and lease liabilities, allowance for credit losses 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.

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.

REVENUE RECOGNITION AND RELATED ALLOWANCES

3 Months Ended

Mar. 31, 2022

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
Products and Services	March 31,		March 31,
(in thousands)	2022		2021
Sales of generic pharmaceutical products	$	49,107	$	32,988
Sales of established brand pharmaceutical products		8,452		7,517
Sales of rare disease pharmaceutical products		1,292		—
Sales of contract manufactured products		2,904		2,573
Royalties from licensing agreements		1,903		11,210
Product development services		566		158
Other		253		75
Total net revenues	$	64,477	$	54,521


		Three Months Ended

Timing of Revenue Recognition	March 31,		March 31,
(in thousands)	2022		2021
Performance obligations transferred at a point in time	$	63,911	$	54,363
Performance obligations transferred over time		566		158
Total	$	64,477	$	54,521

In the three months ended March 31, 2022 and 2021, we did not incur, and therefore did not defer, any material incremental costs to fulfill contracts. We recognized a decrease of $1.3 million to net revenue from performance obligations satisfied in prior periods during the three months ended March 31, 2022, consisting primarily of revised estimates for variable consideration, including chargebacks, rebates, returns, and other allowances, related to prior period sales. We recognized an increase of $10.7 million to net revenue from performance obligations satisfied in prior periods during the three months ended March 31, 2021, consisting primarily of a final royalty revenue related to the Kite license agreement pursuant to the Tripartite Agreement as described herein in Royalties from Licensing Agreements. We provide technical transfer services to customers, for which services are transferred over time. As of March 31, 2022 and December 31, 2021, 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 March 31, 2022 and December 31, 2021. For the three months ended March 31, 2022, we recognized less than $0.1 million of revenue that was included in deferred revenue as of December 31, 2021. For the three months ended March 31, 2021, we recognized less than $0.1 million of revenue that was included in deferred revenue as of December 31, 2020.

Revenue from Sales of Generic and Branded Pharmaceutical Products

Product sales consists of sales of our generic and branded pharmaceutical products, including rare disease 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.

The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the three months ended March 31, 2022 and 2021, 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, 2020 (1)	$	88,746	$	7,826	$	27,155	$	8,906	$	3,839
Accruals/Adjustments		96,701		4,656		4,811		7,634		3,196
Credits Taken Against Reserve		(114,114)		(3,810)		(3,022)		(9,184)		(3,959)
Balance at March 31, 2021 (1)	$	71,333	$	8,672	$	28,944	$	7,356	$	3,076

Balance at December 31, 2021 (1)	$	94,066	$	5,492	$	35,831	$	13,100	$	4,642
Accruals/Adjustments		152,566		2,810		6,942		9,785		5,060
Credits Taken Against Reserve		(142,991)		(3,745)		(7,219)		(10,915)		(4,539)
Balance at March 31, 2022 (1)	$	103,641	$	4,557	$	35,554	$	11,970	$	5,163

(1)

Chargebacks are included as an offset to accounts receivable in the unaudited interim 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 interim condensed consolidated balance sheets. Returns are included in returned goods reserve in the unaudited interim condensed consolidated balance sheets. Government Rebates are included in accrued government rebates in the unaudited interim 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 March 31, 2022, the aggregate amount of the transaction price allocated to the remaining performance obligations for all open contract manufacturing customer contracts was $6.2 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, during the three month period ended March 31, 2021, 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, we do 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 are services primarily performed at our facilities in East Windsor, New Jersey and Oakville, Ontario. The duration of these development 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 March 31, 2022, the aggregate amount of the transaction price allocated to the remaining performance obligations for all open product development services contracts was $0.1 million. We expect to satisfy these performance obligations within the next 12 months.

Credit Concentration

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

During the three months ended March 31, 2022 and 2021 we had three customers that accounted for 10% or more of net revenues. As of March 31, 2022, accounts receivable from these customers totaled 84% of accounts receivable, net.

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


	Three Months Ended
	March 31,		March 31,
	2022		2021
Customer 1	31	%	28	%
Customer 2	19	%	24	%
Customer 3	14	%	16	%

- 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
-URI http://asc.fasb.org/topic&trid=49130388

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 10
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130551-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130556-203045

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130554-203045

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
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-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130550-203045

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-Paragraph 12
-Subparagraph (e)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130554-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130554-203045

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (d)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130554-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 15
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130558-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=123351226&loc=SL49130554-203045

+ Details

BUSINESS COMBINATION

3 Months Ended

Mar. 31, 2022

BUSINESS COMBINATION

BUSINESS COMBINATION

3.	BUSINESS COMBINATION

Summary

On November 19, 2021, we completed our previously announced acquisition of all of the interests of Novitium pursuant to the terms of the Agreement and Plan of Merger (the “Merger Agreement”), dated as of March 8, 2021, for cash consideration, 2,466,654 restricted shares of our common stock valued at $91.2 million based on our closing stock price of $43.54 on the date of closing and discounted for lack of marketability due to restrictions on shares, and up to $46.5 million in additional contingent consideration. Additionally, we agreed to pay certain debts of Novitium in the amount of $8.5 million, which we deemed to be paid in consummation of the transaction closing, and not assumed liabilities, and thus were included as additional cash consideration. This acquisition was accounted for as a business combination. The contingent consideration is based on the achievement of certain milestones, including milestones on gross profit of Novitium portfolio products over a 24-month period, regulatory filings completed during this 24-month period, and a percentage of net profits on certain products that are launched in the future. As of the closing of the acquisition, the contingent consideration had a fair value of $30.8 million. Total consideration including cash, restricted shares and contingent consideration was valued at $206.5 million.

Purchase consideration consisted of the following:


	(in thousands)
Cash consideration	$	88,076
Repayment of Novitium debts		8,493
Fair value of restricted shares		91,199
Fair value of contingent consideration		30,800
Gross consideration	$	218,568
Cash acquired		12,076
Net consideration	$	206,492

The cash consideration was funded in part by borrowings under our new credit facility (Note 4) and through issuance of shares of Series A convertible preferred stock (Note 9). We acquired Novitium due to its proven track record of being a research and development growth engine capable of fueling sustainable growth, to expand our research and development pipeline via niche opportunities, to enhance our contract development and manufacturing organization (“CDMO”) business and U.S. based manufacturing capacity, and to diversify our revenue base.

The preliminary allocation of the fair value of the Novitium acquisition, reflective of certain immaterial measurement period adjustments during the three months ended March 31, 2022, is shown in the table below. The allocation of the fair value will be finalized when the valuation is completed and the differences will be trued up for the final allocated amounts.


	(in thousands)
Total Purchase Consideration	$	218,568
Cash and cash equivalents		12,076
Accounts receivable		27,185
Inventories		14,460
Prepaid expenses and other current assets		1,891
Property and equipment		14,331
Intangible assets		139,200
Goodwill		24,608
Other non-current assets		1,413
Total assets acquired		235,164
Accounts payable		1,560
Accrued expense and other current liabilities		6,035
Accrued compensation and other related expenses		4,909
Accrued government rebates		744
Returned goods reserve		2,202
Other non-current liabilities		1,146
Total liabilities assumed		16,596
Net assets acquired	$	218,568

The net assets were recorded at their estimated fair value. In valuing acquired assets and liabilities, fair value estimates were based primarily on future expected cash flows, market rate assumptions for contractual obligations, and appropriate discount rates. In connection with the acquisition, we recognized $46.9 million of indefinite-lived in-process research and development intangible assets, $67.4 million of acquired ANDA intangible assets, and $24.9 million of customer relationship intangible assets.

Goodwill is considered an indefinite-lived asset and relates primarily to intangible assets that do not qualify for separate recognition, such as the assembled workforce and synergies between the entities. Goodwill established as a result of the acquisition is tax deductible in the U.S.

Novitium operations generated $19.2 million of revenue and recorded a net loss of $0.2 million during the three months ended March 31, 2022.

Restricted Shares

The Novitium acquisition consideration included 2,466,654 restricted shares, which were valued at $91.2 million. These shares contain restrictions on their transfer for periods from three to 24 months following the completion of the acquisition. A Finnerty model was used to value the restricted shares. It includes inputs of not readily observable market data, which are Level 3 inputs. These unobservable inputs include ANI stock volatility with a range of 65% - 71%, and the discounted lack of marketability with a range of 7.5% - 21.5% depending on the length of restriction.

INDEBTEDNESS

3 Months Ended

Mar. 31, 2022

INDEBTEDNESS

INDEBTEDNESS

4.	INDEBTEDNESS

Credit Facility

On November 19, 2021, the Company, as borrower, entered into a credit agreement (the “Credit Agreement”) with Truist Bank and other lenders, which provides for credit facilities consisting of (i) a senior secured term loan facility in an aggregate principal amount of $300.0 million (the “Term Facility”) and (ii) a senior secured revolving credit facility in an aggregate commitment amount of $40.0 million, which may be used for revolving credit loans, swingline loans and letters of credit (the “Revolving Facility,” and together with the Term Facility, the “Credit Facility”).

The Term Facility proceeds were used to finance the cash portion of the consideration under the merger agreement between ANI and Novitium, repay our existing credit facility, and pay fees, costs and expenses incurred in connection with the merger. Proceeds of the Revolving Facility are expected to be used, subject to certain limitations, for working capital and other general corporate purposes.

The Term Facility matures in November 2027 and the Revolving Facility in November 2026. Each permits both base rate borrowings (“ABR Loans”) and Eurodollar rate borrowings (“Eurodollar Loans”), plus a spread of (a) 5.00% above the base rate in the case of ABR Loans under the Term Facility and 6.00% above the LIBOR Rate (as defined in the Credit Agreement) in the case of LIBOR loans under the Term Facility and (b) 3.75% above the base rate in the case of ABR Loans under the Revolving Facility and 4.75% above the LIBOR Rate (as defined in the Credit Facility) in the case of loans under the Revolving Facility. The interest rate under the Term Facility was 6.75% at March 31, 2022. The Credit Facility has a subjective acceleration clause in case of a material adverse effect. The Term Facility includes a repayment schedule, pursuant to which $750 thousand of the loan will be paid in quarterly installments during the twelve months ended March 31, 2023. As of March 31, 2022, $3.0 million of the loan is recorded as current borrowings in the unaudited interim condensed consolidated balance sheets. As of March 31, 2022, we have not drawn on the Revolving Facility and $40.0 million remained available for borrowing.

We incurred $14.0 million in deferred debt issuance costs associated with the Credit Facility. Costs allocated to the Term Facility are classified as a direct reduction to the current and non-current portion of the borrowings, depending on their nature. Costs allocated to the Revolving Facility are classified as other current and other non-current assets, depending on their nature. We incur a commitment fee of 0.5% per annum on any unused portion of the Revolving Facility.

In connection with entry into the Credit Facility, on November 19, 2021, we terminated our existing Amended and Restated Credit Agreement, dated as of December 27, 2018 (the “Prior Credit Agreement”), among the Company, as borrower, and Citizens Bank with other lenders.

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 Facility as of March 31, 2022 and December 31, 2021 are:


	Current
	March 31,		December 31,
(in thousands)	2022		2021
Current borrowing on debt	$	3,000	$	3,000
Deferred financing costs		(2,150)		(2,150)
Current debt, net of deferred financing costs	$	850	$	850


	Non-Current
	March 31,		December 31,
(in thousands)	2022		2021
Non-current borrowing on debt	$	296,250	$	297,000
Deferred financing costs		(9,943)		(10,480)
Non-current debt, net of deferred financing costs and current component	$	286,307	$	286,520

As of March 31, 2022, we had a $299.3 million balance on the Term Facility. Of the $1.0 million of deferred debt issuance costs allocated to the Revolving Facility, $0.8 million is included in other non-current assets in the unaudited interim condensed consolidated balance sheets, and $0.2 million is included in prepaid expenses and other current assets in the unaudited interim condensed consolidated balance sheets.

The contractual maturity of our Term Facility is as follows for the years ending December 31:


(in thousands)	Term Facility
2022	$	2,250
2023		3,000
2024		3,000
2025		3,000
2026		3,000
2027 and thereafter		285,000
Total	$	299,250

The following table sets forth the components of total interest expense related to the Term Facility during the three months ended March 21, 2022 and interest expense under the Prior Credit Agreement during the three months ended March 31, 2021, as recognized in the accompanying unaudited interim condensed consolidated statements of operations for the three months ended March 31, 2022 and 2021:


	Three Months Ended
	March 31,		March 31,
(in thousands)	2022		2021
Contractual coupon	$	6,058	$	2,304
Amortization of finance fees		591		177
Capitalized interest		(30)		(26)
	$	6,619	$	2,455

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

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+ Details

DERIVATIVE FINANCIAL INSTRUMENT AND HEDGING ACTIVITY

3 Months Ended

Mar. 31, 2022

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 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 term facilities related to our Prior Credit Agreement. The interest rate swap matures in December 2026. Concurrent with the termination of the Prior Credit Agreement and entry into the Credit Agreement with Truist Bank, the interest rate swap with a notional value of $168.6 million was novated and Truist Bank is the new counterparty. The swap is used to manage changes in LIBOR-based interest rates underlying a portion of the borrowing under the Term Facility. The interest rate swap provides an effective fixed interest rate of 2.26% and has been designated as an effective cash flow hedge and therefore qualifies for hedge accounting. As of March 31, 2022, the notional amount of the interest rate swap was $162.2 million and decreases quarterly by approximately $4.0 million until December 2023, after which it remains static until maturity in December 2026. As of March 31, 2022, the fair value of the interest rate swap asset recorded in derivatives and other non-current assets in the unaudited interim condensed consolidated balance sheets was $0.4 million. As of March 31, 2022, $2.7 million was recorded in accumulated other comprehensive loss, net of tax in the unaudited interim condensed consolidated balance sheets.

During the three months ended March 31, 2022, the change in fair value of the interest rate swaps was a gain of $6.9 million. During the three months ended March 31, 2022, gains on the interest rate swap of $5.8 million were recorded in accumulated other comprehensive loss, net of tax in our unaudited interim condensed consolidated statements of comprehensive (loss)/income. Differences between the hedged LIBOR rate and the fixed rate are recorded as interest expense in the same period that the related interest is recorded for the Term Facility based on the LIBOR rate. In the three months ended March 31, 2022, $1.0 million of interest expense was recognized in relation to the interest rate swaps. Included in this amount for the three months ended March 31, 2022 and 2021 are reclassifications out of accumulated other comprehensive income/loss of $0.7 million and $0.9 million in expense, respectively, related to terminated and de-designated cash flow hedges.

EARNINGS (LOSS) PER SHARE

3 Months Ended

Mar. 31, 2022

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 stockholders 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 stockholders 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 and Series A convertible preferred stock 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 the common shares assumed converted from the preferred shares and excludes the impact of those shares from the denominator.

Earnings (loss) per share for the three months ended March 31, 2022 and 2021 are calculated for basic and diluted earnings (loss) per share as follows:


	Basic				Diluted
(in thousands, except per share amounts)	Three Months Ended March 31,				Three Months Ended March 31,
	2022		2021		2022		2021
Net (loss)/income	$	(20,130)	$	86	$	(20,130)	$	86
Net income allocated to participating securities		—		(5)		—		(5)
Dividends on Series A convertible preferred stock		(405)		—		(405)		—
Net (loss)/income available to common shareholders	$	(20,535)	$	81	$	(20,535)	$	81
Basic Weighted-Average Shares Outstanding		16,137		12,004		16,137		12,004
Dilutive effect of stock options and ESPP						—		13
Diluted Weighted-Average Shares Outstanding						16,137		12,017

(Loss)/Income per share	$	(1.27)	$	0.01	$	(1.27)	$	0.01

The number of anti-dilutive shares, which have been excluded from the computation of diluted earnings (loss) per share, was 2.5 million and 1.7 million for the three months ended March 31, 2022 and 2021, respectively. For the three months ended March 31, 2022, 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 March 31, 2021, 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

3 Months Ended

Mar. 31, 2022

INVENTORIES

INVENTORIES

7.	INVENTORIES

Inventories consist of the following as of:


	March 31,		December 31,
(in thousands)	2022		2021
Raw materials	$	52,816	$	51,350
Packaging materials		5,560		5,475
Work-in-progress		615		652
Finished goods		31,363		31,969
		90,354		89,446
Reserve for excess/obsolete inventories		(7,199)		(7,753)
Inventories, net	$	83,155	$	81,693

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 months ended March 31, 2022, one vendor represented 16% of inventory purchases. As of March 31, 2022, our accounts payable to this supplier was zero. During the three months ended March 31, 2021, we purchased approximately 11% of our inventory from one supplier.

GOODWILL AND INTANGIBLE ASSETS

3 Months Ended

Mar. 31, 2022

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. From our acquisition of Novitium in 2021, we recorded goodwill of $24.6 million. 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 three months ended March 31, 2022. No impairment losses were recognized during the three months ended March 31, 2022 and 2021.

Intangible Assets

The components of net definite-lived intangible assets and net indefinite-lived intangible assets other than goodwill are as follows:


	March 31, 2022				December 31, 2021				Weighted Average
	Gross Carrying		Accumulated		Gross Carrying		Accumulated		Amortization
(in thousands)	Amount		Amortization		Amount		Amortization		Period
Definite-Lived Intangible Assets:
Acquired ANDA intangible assets	$	168,536	$	(59,127)	$	168,536	$	(54,079)	8.5	years
NDAs and product rights		242,372		(145,184)		242,372		(138,835)	9.9	years
Marketing and distribution rights		17,157		(12,588)		17,157		(12,347)	5.5	years
Non-compete agreement		624		(535)		624		(513)	7.0	years
Customer relationships		24,900		(1,482)		24,900		(593)	7.0	years
Indefinite-Lived Intangible Assets:
In process research and development		46,900		—		46,900		—	Indefinite
Total Intangible Assets, net	$	500,489	$	(218,916)	$	500,489	$	(206,367)	9.0	years

The definite-lived Abbreviated New Drug Applications (“ANDAs”), New Drug Applications (“NDAs”) and product rights, marketing and distribution rights, customer relationships, and non-compete agreement are stated at cost, net of amortization, and generally amortized over their remaining estimated useful lives, ranging from seven to 10 years, based on the straight-line method. In the case of certain NDA and product rights assets, we use an accelerated amortization method to better match the anticipated economic benefits expected to be provided. Our indefinite-lived intangible assets other than goodwill include in-process research and development (“IPR&D”) projects. IPR&D intangible assets represent the fair value of technology acquired in a business combination for which the technology projects are incomplete but have substance. When an IPR&D project is completed (generally upon receipt of regulatory approval), the asset is then accounted for as a definite-lived intangible asset.

Amortization expense was $12.5 million and $9.7 million for the three months ended March 31, 2022 and 2021, respectively. Refer to Note 13 for more details on acquired definite-lived intangible assets.

We test for impairment of definite-lived intangible assets and indefinite-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 months ended March 31, 2022 and 2021 and therefore no impairment loss was recognized in the three months ended March 31, 2022 and 2021.

Expected future amortization expense is as follows:


(in thousands)
2022 (remainder of the year)	$	36,572
2023		50,792
2024		49,997
2025		47,893
2026		34,574
2027 and thereafter		61,745
Total	$	281,573

MEZZANINE AND STOCKHOLDERS' EQUITY

3 Months Ended

Mar. 31, 2022

MEZZANINE AND STOCKHOLDERS' EQUITY

MEZZANINE AND STOCKHOLDERS' EQUITY

9.	MEZZANINE AND STOCKHOLDERS’ EQUITY

Stockholders’ Equity

Authorized shares

We are authorized to issue up to 33.3 million shares of common stock with a par value of $0.0001 per share, 0.8 million shares of class C special stock with a par value of $0.0001 per share, and 1.7 million shares of undesignated preferred stock with a par value of $0.0001 per share at March 31, 2022.

There were 17.4 million and 17.3 million shares of common stock issued and outstanding as of March 31, 2022 and 16.9 million shares of common stock issued and outstanding as of December 31, 2021. During 2021, we issued 1.5 million shares related to a public offering of our common stock and 2.5 million shares as consideration in connection with the acquisition of Novitium.

There were 11 thousand shares of class C special stock issued and outstanding as of March 31, 2022 and December 31, 2021. Each share of class C special stock entitles its holder to one vote per share. Each share of class C special stock is exchangeable, at the option of the holder, for one share of our common stock, at an exchange price of $90.00 per share, subject to adjustment upon certain capitalization events. Holders of class C special stock are not entitled to receive dividends or to participate in the distribution of our assets if we were to liquidate, dissolve, or wind-up the company. The holders of class C special stock have no cumulative voting, preemptive, subscription, redemption, or sinking fund rights.

Mezzanine Equity

PIPE Shares

Concurrently with the execution of the Merger Agreement, and as financing for a portion of the acquisition, 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. This agreement closed and the 25,000 PIPE Shares were sold and issued for $25.0 million on November 19, 2021. The PIPE Shares are classified as mezzanine equity because the shares are mandatorily redeemable for cash upon a change in control, an event that is not solely in our control. We incurred $0.2 million in issuance costs associated with the transaction.

The PIPE Shares accrue dividends at 6.50% per year on a cumulative basis, payable in cash or in-kind, and will also participate, on a pro-rata basis, in any dividends that may be declared with respect to our common stock. The PIPE

Shares are convertible into our common shares at the conversion price of $41.47 (i) beginning two years after their issuance date, at the election of ANI (in which case the PIPE Investor must convert all of the PIPE Shares), if the volume-weighted average price of our common stock for any 20 trading days out of 30 consecutive trading days exceeds 170% of the conversion price, and (ii) at any time after issuance, at the election of the PIPE Investor. As of March 31, 2022, the PIPE shares are currently convertible into a maximum of 602,901 shares of our common stock.

In case of a liquidation event, the holder of the PIPE Shares will be entitled to receive, in preference to holders of our common stock, the greater of (i) the PIPE Shares’ purchase price plus any accrued and unpaid dividends thereon and (ii) the amount the holder of the PIPE Shares would have received in the liquidation event if it had converted its PIPE Shares into our common stock. The PIPE Shares will have voting rights, voting as one series with our common stock, on as-converted basis, and will have separate voting rights on any (i) amendment to the Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (the “Certificate”) that adversely amends and relates solely to the terms of the PIPE Shares and (ii) issuance of additional Series A convertible preferred stock. In case of a change of control of ANI, the PIPE Shares will be redeemed at the greater of (i) the PIPE Shares’ purchase price plus any accrued and unpaid dividends thereon and (ii) the change of control transaction consideration that the holder of the PIPE Shares would have received if it had converted into our common stock.

There were 25,000 shares of Series A convertible preferred stock outstanding as of March 31, 2022.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

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+ Details

STOCK-BASED COMPENSATION

3 Months Ended

Mar. 31, 2022

STOCK-BASED COMPENSATION

STOCK-BASED COMPENSATION

10.	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 March 31, 2022, 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 March 31,
	2022		2021
Cost of sales	$	10	$	4
Research and development		7		5
Selling, general, and administrative		21		23
	$	38	$	32

Stock Incentive Plan

Equity-based service awards are granted under the ANI Pharmaceuticals, Inc. Amended and Restated 2022 Stock Incentive Plan (the “2022 Plan”), which was approved by our stockholders at the 2022 Annual Meeting of Stockholders (the “Annual Meeting”) held on April 27, 2022. Prior to this approval, we had been granting equity-based incentive awards under our Sixth Amended and Restated 2008 Stock Incentive Plan (the “the Existing Plan”). As of March 31, 2022, 0.1 million shares of our common stock were available for issuance under the Existing Plan. The approved 2022 Plan was amended to, among other things, increase the number of shares reserved for issuance thereunder by 1,150,000 shares.

From time to time, we may grant stock options to employees through an inducement grant outside of our 2022 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 2022 Plan and Inducement Grants included in our accompanying unaudited interim condensed consolidated statements of operations:


(in thousands)	Three Months Ended March 31,
	2022		2021
Cost of sales	$	135	$	—
Research and development		246		114
Selling, general, and administrative		2,818		1,723
	$	3,199	$	1,837

A summary of stock option and restricted stock activity under the 2022 Plan and Inducement Grants during the three months ended March 31, 2022 and 2021 is presented below:


(in thousands)	Options	Inducement Grants	RSAs
Outstanding at December 31, 2020	756	180	352
Granted	42	61	438
Options Exercised/RSAs Vested	—	—	(34)	⁽¹⁾
Forfeited	(10)	—	(38)
Expired	—	—	—
Outstanding at March 31, 2021	788	241	718

Outstanding at December 31, 2021	747	241	707
Granted	27	—	460
Options Exercised/RSAs Vested	—	—	(161)	⁽²⁾
Forfeited	—	—	—
Expired	—	—	—
Outstanding at March 31, 2022	774	241	1,006

(1)

Includes 10 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 $348 thousand total purchase price for the shares is included in Treasury stock in our accompanying unaudited interim condensed consolidated balance sheets.

(2)

Includes 40 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 $1.1 million total purchase price for the shares is included in Treasury stock in our accompanying unaudited interim condensed consolidated balance sheets.

INCOME TAXES

3 Months Ended

Mar. 31, 2022

INCOME TAXES

INCOME TAXES

11.	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 March 31, 2022, 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 March 31, 2022 and December 31, 2021. 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. 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 and Indian 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 March 31, 2022, we recognized an income tax benefit of $5.8 million. The income tax benefit resulted from applying an estimated annual worldwide effective tax benefit rate of 22.3% to pre-tax consolidated loss of $25.9 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 March 31, 2022.

For the three months ended March 31, 2021, we recognized an income tax benefit of less than $0.1 million. The income tax benefit resulted from applying an estimated annual worldwide effective tax benefit rate of 27.7% to pre-tax consolidated income of $0.1 million reported during the period, reduced by 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 March 31, 2021.

- 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

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI http://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI http://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 14
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI http://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI http://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI http://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI http://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

COMMITMENTS AND CONTINGENCIES

3 Months Ended

Mar. 31, 2022

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES

12.	COMMITMENTS AND CONTINGENCIES

Operating Leases

All our existing leases as of March 31, 2022 are classified as operating leases. As of March 31, 2022, we have twelve material operating leases for facilities and office equipment with remaining terms expiring from 2022 through 2026 and a weighted average remaining lease term of 2.9 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%. Current lease liability is included in accrued expenses and other in the accompanying unaudited interim condensed consolidated balance sheets. Non-current lease liability is included in derivatives and other non-current liabilities in the accompanying unaudited interim condensed consolidated balance sheets.

Rent expense for the three months ended March 31, 2022 and 2021 consisted of the following:


	Three Months Ended March 31,
(in thousands)	2022		2021
Operating lease costs	$	126	$	49
Variable lease costs		66		7
Total lease costs	$	192	$	56

A maturity analysis of our operating leases follows:


(in thousands)
Future payments:
2022	$	344
2023		428
2024		412
2025		190
2026 and thereafter		51
Total	$	1,425

Discount		(143)
Lease liability		1,282
Current lease liability		(380)
Non-current lease liability	$	902

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 Food and Drug Administration (“FDA”), the Centers for Medicare and Medicaid Services (“CMS”), Health Canada, the Central Drugs Standard Control Organization (“CDSCO”), The Narcotics Control Bureau (“NCB”), and India’s Ministry of Health and Family Welfare (“MoHFW”). The FDA, in particular, maintains oversight of the formulation, manufacture, distribution, packaging, and labeling of all of our products. The DEA, Health Canada, and NCB 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 ANDAs. During the three months ended March 31, 2022 and 2021, net revenues for these products totaled $4.0 million and $3.8 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 March 31, 2022 and 2021 were $0.6 million and $0.8 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 alleged that the 2013 patent litigation settlement agreement between Forest and Amerigen violated federal and state antitrust laws and state consumer protection laws by delaying the market entry

of generic versions of Bystolic. Plaintiffs alleged they paid higher prices as a result of delayed generic competition. Plaintiffs sought damages, trebled or otherwise multiplied under applicable law, injunctive relief, litigation costs and attorneys’ fees. The complaints did 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. On January 24, 2022, the court dismissed all claims brought by the plaintiffs without prejudice. The court granted the plaintiffs until February 22, 2022 to file amended complaints, which were filed on that date. The newly amended complaints contain substantially similar claims. On April 19, 2022, the Company and other defendants filed motions to dismiss the newly amended complaints. 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 sought injunctive relief, damages, including lost profits and/or royalty, treble damages, and attorneys’ fee and costs. On February 15, 2022, the Company entered into a settlement agreement with Azurity to resolve all claims related to this action. Under the terms of the agreement, Azurity granted ANI a non-exclusive, non-transferable, non-sublicensable, royalty-bearing license under its Patents to sell ANI product in the United States and dismissed the action with prejudice. In exchange, we paid Azurity $1.9 million of royalties from past sales and we will pay Azurity a royalty equal to 20% of gross margin of sales of the ANI product for a contractually defined term. We paid the settlement from cash on hand and the $1.9 million charge was recorded as cost of sales (excluding depreciation and amortization) on the consolidated statement of operations for the year ended December 31, 2021.

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, ANI and Novitium 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 ANI and Novitium. 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. Novitium is named as a Defendant in the amended complaint. According to Novitium’s records, Novitium sold approximately 42 bottles of ranitidine indirectly into New Mexico, and received no funds from any state funded health care plan or Medicaid. The Defendants filed a motion to dismiss the claims asserted in the New Mexico litigation based primarily on preemption. The motion was denied in August 2021.

In December 2020, the City of Baltimore served ANI and Novitium 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. Novitium was named as a defendant in the amended complaint. Defendants in the Baltimore action filed a motion to dismiss on based primarily on preemption to which Novitium joined. The motion was granted as to all generic manufacturer defendants on January 28, 2022, and all claims against Novitium were dismissed with prejudice. The deadline for the City to file an appeal was February 28, 2022.

ANI and Novitium 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, ANI was 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 ANI and Novitium as defendants. ANI 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 did not name ANI but did name Novitium. By opinion dated July 8, 2021, the district court dismissed all claims against the generic manufacturer defendants with prejudice on preemption grounds. That decision is on appeal to the Eleventh Circuit Court of Appeals.

ANI and Novitium were 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. ANI was 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 ANI 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. ANI’s 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.

Novitium has been named in 155 short form complaints filed by claimants in the MDL. Those complaints were effectively dismissed with prejudice with the MPIC on July 8, 2021. Counsel for the plaintiffs have been notified that Novitium did not sell an over the counter ranitidine product and sold a generic prescription ranitidine product for a limited period of time, from December 2018 until September 2019. Novitium’s product was voluntarily recalled in October 2019. Out of the 155 short form complaints, approximately 111 plaintiffs either were diagnosed with cancer before Novitium began manufacturing the product, only took over the counter ranitidine, or took ranitidine before Novitium began manufacturing it. In light of the Court’s dismissal of all claims with prejudice, Novitium has not pursued dismissal of the short form complaints against it at this time.

On February 3, 2022, a complaint was filed in Cook County, Illinois, naming Novitium as a Defendant. The complaint incorrectly identifies Novitium as a “repackager.” The case is styled Ross v. Boehringer Ingelheim Pharmaceuticals, Inc., et. al. The complaint asserts claims of strict liability/failure to warn, strict liability/design defect, negligent failure to warn, negligent product design, general negligence, negligent misrepresentation, breach of express and implied warranties, and unjust enrichment. The Plaintiff alleges that he was diagnosed with prostate cancer in 2017 – before Novitium began selling generic ranitidine products -- and that he took over the counter ranitidine that he purchased at Walgreens from 2008-2019. At this point, the allegations show that the Plaintiff’s alleged cancer injury could not have come from a Novitium product. The generic manufacturer defendants filed a motion to dismiss on preemption grounds, which has not been fully briefed, and is still pending.

ANI and Novitium 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

3 Months Ended

Mar. 31, 2022

FAIR VALUE DISCLOSURES

FAIR VALUE DISCLOSURES

13.	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 Facility bears 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 March 31, 2022.

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

Contingent Value Rights

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 March 31, 2022 and December 31, 2021. We also determined that the changes in such fair value were immaterial in the three months ended March 31, 2022 and 2021.

Interest Rate Swap

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 $0.4 million asset at March 31, 2022.

Contingent Consideration

In connection with the acquisition of Novitium, we may pay up to $46.5 million in additional consideration related to the achievement of certain milestones, including milestones on gross profit of Novitium portfolio products over a 24-month period, regulatory filings completed during this 24-month period, and a percentage of net profits on certain products that are launched in the future.

The discounted cash flow method used to value this contingent consideration includes inputs of not readily observable market data, which are Level 3 inputs. The recurring Level 3 fair value measurements of contingent consideration for which a liability is recorded include the following significant unobservable inputs:


Payment Type	Valuation Technique	Unobservable Input	Range
Profit-based milestone payments	Probability-weighted discounted cash flow	Discount rate	12.3%
		Projected fiscal year of payment	2023-2029


Product development-based milestone payments	Probability-weighted discounted cash flow	Discount rate	10.0%
		Probability of payment	90.0%
		Projected fiscal year of payment	2023-2024

The following table presents the changes in contingent consideration balances classified as Level 3 balances for the three months ended March 31, 2022 and 2021:


	Three Months Ended March 31,
(in thousands)	2022		2021
Beginning balance	$	31,000	$	—
Measurement period adjustment		300		—
Change in fair value		753		—
Ending balance	$	32,053	$	—

The following table presents our financial assets and liabilities accounted for at fair value on a recurring basis as of March 31, 2022 and December 31, 2021, by level within the fair value hierarchy:


(in thousands)	Fair Value at
Description	March 31, 2022		Level 1		Level 2		Level 3
Assets
Interest rate swap	$	431	$	—	$	431	$	—
Liabilities
Contingent consideration	$	32,053	$	—	$	—	$	32,053
CVRs	$	—	$	—	$	—	$	—


	Fair Value at
Description	December 31, 2021		Level 1		Level 2		Level 3
Liabilities
Contingent consideration	$	31,000	$	—	$	—	$	31,000
Interest rate swaps	$	6,790	$	—	$	6,790	$	—
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 months ended March 31, 2022 and 2021.

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 Prior 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 March 31, 2022 and therefore no impairment loss was recognized for the three months ended March 31, 2022.

- 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

3 Months Ended

Mar. 31, 2022

PURIFIED CORTROPHIN GEL PRE-LAUNCH CHARGES

PURIFIED CORTROPHIN GEL PRE-LAUNCH CHARGES

14.	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 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 are recorded as inventory at net realizable value.

RELATED PARTY TRANSACTIONS

3 Months Ended

Mar. 31, 2022

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS

15. RELATED PARTY TRANSACTIONS

On March 8, 2021, we entered into an Equity Commitment and Investment Agreement with Ampersand 2020 Limited Partnership, pursuant to which we agreed to issue and sell 25,000 shares of our PIPE Shares for a purchase price of $1,000 per share and an aggregate purchase price of $25.0 million. This agreement closed and the shares were sold and issued for $25.0 million on November 19, 2021. The Chairman of our board of directors is an operating partner of Ampersand Capital Partners, an affiliate of the PIPE Investor.

In connection with our acquisition of Novitium, we entered into employment agreements with the two executives and founders of Novitium, Muthusamy Shanmugam and Chad Gassert. Both will serve as executive officers of the Company and Mr. Shanmugam was also appointed to the board of directors. Mr. Shanmugam holds a minority interest in Scitus Pharma Services (“Scitus”), which provides clinical research services to Novitium, majority interest in SS Pharma LLC (“SS Pharma”), which acquires and supplies API to Novitium, majority interest in Esjay Pharma LLC (“Esjay”), which provides research and development and facilities consulting services, and a minority interest in Nuray Chemical Private Limited (“Nuray”), which manufactures and supplies API to Novitium. Mr. Gassert holds a minority interest in Scitus. During the three months ended March 31, 2022, we paid Esjay an immaterial amount, paid SS Pharma $1.0 million, paid Nuray $0.9 million, and paid Scitus $0.6 million. As of March 31, 2022, the outstanding balance due to Scitus was $0.1 million. As of March 31, 2022, there were no outstanding balances due to SS Pharma, Esjay, and Nuray.

SEGMENT REPORTING

3 Months Ended

Mar. 31, 2022

SEGMENT REPORTING

SEGMENT REPORTING

16. SEGMENT REPORTING

An operating segment is defined as a component of an entity that engages in business activities from which it may recognize revenues and incur expense, its operating results are regularly reviewed by the entity’s chief operating decision maker (“CODM”) to make decisions about resources to be allocated to the segment and assess its performance, and its discrete financial information is available. Prior to 2022, based on this definition, we had concluded that we had one operating segment. Effective in the first quarter of 2022 and prospectively, in conjunction with the principal completion of our buildout of infrastructure in the areas of commercialization of rare disease therapies and the launch of Purified Cortrophin Gel, we determined that we have two operating segments as follows:

●

Generics, Established Brands, and Other – Consists of operations related to the development, manufacturing, and marketing of generic and established brand pharmaceuticals, including those sold through traditional channels, contract manufactured products, product development services, royalties, and other.

●

Rare Disease – Consists of operations related to the development, manufacturing and marketing of pharmaceuticals used in the treatment of patients with rare conditions. The rare disease segment currently consists of operations related to Purified Cortrophin Gel.

Our CODM evaluates our two operating segments based on revenues and earnings before interest, income taxes, depreciation, and amortization (“EBITDA”), exclusive of corporate expenses and other expenses not directly allocated or attributable to an operating segment. These expenses include but are not limited to certain management, legal, accounting, human resources, insurance, and information technology expenses.

We do not manage assets of the company by operating segment and our CODM does not review asset information by operating segment. Accordingly, we do not present total assets by operating segment.

Financial information by reportable segment is as follows:


	Three Months Ended
(in thousands)	March 31, 2022		March 31, 2021
Net Revenues
Generics, Established Brands, and Other	$	63,185	$	54,521
Rare Disease		1,292		—
Total net revenues	$	64,477	$	54,521

Segment earnings/(loss) before interest, taxes, depreciation and amortization ("EBITDA") and reconciliation to (loss)/income before income taxes
Generics, Established Brands, and Other		14,531		21,839
Rare Disease		(10,448)		(1,278)
Depreciation and amortization		(14,557)		(10,898)
Corporate and other unallocated expenses⁽¹⁾		(8,721)		(6,618)
Total operating (loss)/income	$	(19,195)	$	3,045

Interest expense, net		(6,613)		(2,454)
Other expense, net		(89)		(515)
(Loss)/income before benefit for income taxes	$	(25,897)	$	76

^{(1) Includes expenses not directly allocated or attributable to a reporting segment, including certain management, legal, accounting, human resources, insurance, and information technology expenses, and are included in selling, general, and administrative expenses in our unaudited interim consolidated statement of operations}^.

Geographic Information

Our operations are located in the United States, Canada, and India. 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 March 31,
Location of Operations	2022		2021
United States	$	63,760	$	53,327
Canada		717		1,194
Total Revenue	$	64,477	$	54,521

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


(in thousands)	March 31, 2022		December 31, 2021
United States	$	38,770	$	38,564
Canada		13,685		13,831
India		258		276
Total property and equipment, net	$	52,713	$	52,671

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

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+ Details

BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS (Policies)	3 Months Ended
	Mar. 31, 2022
BUSINESS, PRESENTATION, AND RECENT ACCOUNTING PRONOUNCEMENTS
Organization and Business	Overview ANI Pharmaceuticals, Inc. and its consolidated subsidiaries (together, “ANI,” the “Company,” “we,” “us,” or “our”) is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. Our four pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota, one is located in East Windsor, New Jersey, 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	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, 2021 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, 2021.
Principles of Consolidation	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	Foreign Currency We have subsidiaries located in Canada and India. The Canada-based subsidiary conducts its transactions in U.S. dollars and Canadian dollars, but its functional currency is the U.S. dollar. The Indian-based subsidiary generally conducts its transactions in Indian rupees, which is also its functional currency. The results of any non-U.S. dollar transactions and balances 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 and the translation impact of local currencies to U.S. dollars was immaterial for the three months ended March 31, 2022 and 2021. Unless otherwise noted, all references to “$” or “dollar” refer to the U.S. dollar.
Use of Estimates	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 condensed consolidated financial statements, estimates are used for, but not limited to, variable consideration determined based on accruals for chargebacks, administrative fees and rebates, government rebates, returns and other allowances, income tax provision or benefit, deferred taxes and valuation allowance, stock-based compensation, revenue recognition, allowance for inventory obsolescence, valuation of financial instruments and intangible assets, accruals for contingent liabilities, including contingent consideration in acquisitions, fair value of long-lived assets, determination of right-of-use assets and lease liabilities, allowance for credit losses 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.
Recent Accounting Pronouncements	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.

REVENUE RECOGNITION AND RELATED ALLOWANCES (Tables)

3 Months Ended

Mar. 31, 2022

REVENUE RECOGNITION AND RELATED ALLOWANCES

Schedule of disaggregation of revenue and revenue recognized


	Three Months Ended
Products and Services	March 31,		March 31,
(in thousands)	2022		2021
Sales of generic pharmaceutical products	$	49,107	$	32,988
Sales of established brand pharmaceutical products		8,452		7,517
Sales of rare disease pharmaceutical products		1,292		—
Sales of contract manufactured products		2,904		2,573
Royalties from licensing agreements		1,903		11,210
Product development services		566		158
Other		253		75
Total net revenues	$	64,477	$	54,521


		Three Months Ended

Timing of Revenue Recognition	March 31,		March 31,
(in thousands)	2022		2021
Performance obligations transferred at a point in time	$	63,911	$	54,363
Performance obligations transferred over time		566		158
Total	$	64,477	$	54,521

Schedule of accruals and allowances

The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the three months ended March 31, 2022 and 2021, 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, 2020 (1)	$	88,746	$	7,826	$	27,155	$	8,906	$	3,839
Accruals/Adjustments		96,701		4,656		4,811		7,634		3,196
Credits Taken Against Reserve		(114,114)		(3,810)		(3,022)		(9,184)		(3,959)
Balance at March 31, 2021 (1)	$	71,333	$	8,672	$	28,944	$	7,356	$	3,076

Balance at December 31, 2021 (1)	$	94,066	$	5,492	$	35,831	$	13,100	$	4,642
Accruals/Adjustments		152,566		2,810		6,942		9,785		5,060
Credits Taken Against Reserve		(142,991)		(3,745)		(7,219)		(10,915)		(4,539)
Balance at March 31, 2022 (1)	$	103,641	$	4,557	$	35,554	$	11,970	$	5,163

(1)

Schedule of customer concentration


	Three Months Ended
	March 31,		March 31,
	2022		2021
Customer 1	31	%	28	%
Customer 2	19	%	24	%
Customer 3	14	%	16	%

BUSINESS COMBINATION (Tables)

3 Months Ended

Mar. 31, 2022

BUSINESS COMBINATION

Schedule of purchase consideration


	(in thousands)
Cash consideration	$	88,076
Repayment of Novitium debts		8,493
Fair value of restricted shares		91,199
Fair value of contingent consideration		30,800
Gross consideration	$	218,568
Cash acquired		12,076
Net consideration	$	206,492

Schedule of purchase price allocation


	(in thousands)
Total Purchase Consideration	$	218,568
Cash and cash equivalents		12,076
Accounts receivable		27,185
Inventories		14,460
Prepaid expenses and other current assets		1,891
Property and equipment		14,331
Intangible assets		139,200
Goodwill		24,608
Other non-current assets		1,413
Total assets acquired		235,164
Accounts payable		1,560
Accrued expense and other current liabilities		6,035
Accrued compensation and other related expenses		4,909
Accrued government rebates		744
Returned goods reserve		2,202
Other non-current liabilities		1,146
Total liabilities assumed		16,596
Net assets acquired	$	218,568

INDEBTEDNESS (Tables)

3 Months Ended

Mar. 31, 2022

INDEBTEDNESS

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


	Current
	March 31,		December 31,
(in thousands)	2022		2021
Current borrowing on debt	$	3,000	$	3,000
Deferred financing costs		(2,150)		(2,150)
Current debt, net of deferred financing costs	$	850	$	850


	Non-Current
	March 31,		December 31,
(in thousands)	2022		2021
Non-current borrowing on debt	$	296,250	$	297,000
Deferred financing costs		(9,943)		(10,480)
Non-current debt, net of deferred financing costs and current component	$	286,307	$	286,520

Schedule of contractual maturity of term loan and DDTL

The contractual maturity of our Term Facility is as follows for the years ending December 31:


(in thousands)	Term Facility
2022	$	2,250
2023		3,000
2024		3,000
2025		3,000
2026		3,000
2027 and thereafter		285,000
Total	$	299,250

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


	Three Months Ended
	March 31,		March 31,
(in thousands)	2022		2021
Contractual coupon	$	6,058	$	2,304
Amortization of finance fees		591		177
Capitalized interest		(30)		(26)
	$	6,619	$	2,455

- 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.

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-URI http://asc.fasb.org/extlink&oid=123467817&loc=d3e21475-112644

+ Details

EARNINGS (LOSS) PER SHARE (Tables)

3 Months Ended

Mar. 31, 2022

EARNINGS (LOSS) PER SHARE

Schedule of earnings per share, basic and diluted

Earnings (loss) per share for the three months ended March 31, 2022 and 2021 are calculated for basic and diluted earnings (loss) per share as follows:


	Basic				Diluted
(in thousands, except per share amounts)	Three Months Ended March 31,				Three Months Ended March 31,
	2022		2021		2022		2021
Net (loss)/income	$	(20,130)	$	86	$	(20,130)	$	86
Net income allocated to participating securities		—		(5)		—		(5)
Dividends on Series A convertible preferred stock		(405)		—		(405)		—
Net (loss)/income available to common shareholders	$	(20,535)	$	81	$	(20,535)	$	81
Basic Weighted-Average Shares Outstanding		16,137		12,004		16,137		12,004
Dilutive effect of stock options and ESPP						—		13
Diluted Weighted-Average Shares Outstanding						16,137		12,017

(Loss)/Income per share	$	(1.27)	$	0.01	$	(1.27)	$	0.01

INVENTORIES (Tables)

3 Months Ended

Mar. 31, 2022

INVENTORIES

Schedule of Inventories


	March 31,		December 31,
(in thousands)	2022		2021
Raw materials	$	52,816	$	51,350
Packaging materials		5,560		5,475
Work-in-progress		615		652
Finished goods		31,363		31,969
		90,354		89,446
Reserve for excess/obsolete inventories		(7,199)		(7,753)
Inventories, net	$	83,155	$	81,693

GOODWILL AND INTANGIBLE ASSETS (Tables)

3 Months Ended

Mar. 31, 2022

GOODWILL AND INTANGIBLE ASSETS

Schedule of components of intangible assets


	March 31, 2022				December 31, 2021				Weighted Average
	Gross Carrying		Accumulated		Gross Carrying		Accumulated		Amortization
(in thousands)	Amount		Amortization		Amount		Amortization		Period
Definite-Lived Intangible Assets:
Acquired ANDA intangible assets	$	168,536	$	(59,127)	$	168,536	$	(54,079)	8.5	years
NDAs and product rights		242,372		(145,184)		242,372		(138,835)	9.9	years
Marketing and distribution rights		17,157		(12,588)		17,157		(12,347)	5.5	years
Non-compete agreement		624		(535)		624		(513)	7.0	years
Customer relationships		24,900		(1,482)		24,900		(593)	7.0	years
Indefinite-Lived Intangible Assets:
In process research and development		46,900		—		46,900		—	Indefinite
Total Intangible Assets, net	$	500,489	$	(218,916)	$	500,489	$	(206,367)	9.0	years

Schedule of expected future amortization expense

Expected future amortization expense is as follows:


(in thousands)
2022 (remainder of the year)	$	36,572
2023		50,792
2024		49,997
2025		47,893
2026		34,574
2027 and thereafter		61,745
Total	$	281,573

STOCK-BASED COMPENSATION (Tables)

3 Months Ended

Mar. 31, 2022

Summary of Stock option and restricted stock activity

A summary of stock option and restricted stock activity under the 2022 Plan and Inducement Grants during the three months ended March 31, 2022 and 2021 is presented below:


(in thousands)	Options	Inducement Grants	RSAs
Outstanding at December 31, 2020	756	180	352
Granted	42	61	438
Options Exercised/RSAs Vested	—	—	(34)	⁽¹⁾
Forfeited	(10)	—	(38)
Expired	—	—	—
Outstanding at March 31, 2021	788	241	718

Outstanding at December 31, 2021	747	241	707
Granted	27	—	460
Options Exercised/RSAs Vested	—	—	(161)	⁽²⁾
Forfeited	—	—	—
Expired	—	—	—
Outstanding at March 31, 2022	774	241	1,006

(1)

(2)

Employee Stock Purchase Plan 2016 [Member]

Summary of allocated expense


(in thousands)	Three Months Ended March 31,
	2022		2021
Cost of sales	$	10	$	4
Research and development		7		5
Selling, general, and administrative		21		23
	$	38	$	32

Stock Incentive Plan

Summary of allocated expense


(in thousands)	Three Months Ended March 31,
	2022		2021
Cost of sales	$	135	$	—
Research and development		246		114
Selling, general, and administrative		2,818		1,723
	$	3,199	$	1,837

COMMITMENTS AND CONTINGENCIES (Tables)

3 Months Ended

Mar. 31, 2022

COMMITMENTS AND CONTINGENCIES

Schedule of rent expense


	Three Months Ended March 31,
(in thousands)	2022		2021
Operating lease costs	$	126	$	49
Variable lease costs		66		7
Total lease costs	$	192	$	56

Schedule of maturity analysis of operating leases


(in thousands)
Future payments:
2022	$	344
2023		428
2024		412
2025		190
2026 and thereafter		51
Total	$	1,425

Discount		(143)
Lease liability		1,282
Current lease liability		(380)
Non-current lease liability	$	902

FAIR VALUE DISCLOSURES (Tables)

3 Months Ended

Mar. 31, 2022

FAIR VALUE DISCLOSURES

Schedule of recurring Level 3 fair value measurements of contingent consideration


Payment Type	Valuation Technique	Unobservable Input	Range
Profit-based milestone payments	Probability-weighted discounted cash flow	Discount rate	12.3%
		Projected fiscal year of payment	2023-2029


Product development-based milestone payments	Probability-weighted discounted cash flow	Discount rate	10.0%
		Probability of payment	90.0%
		Projected fiscal year of payment	2023-2024

Schedule of changes in contingent consideration


	Three Months Ended March 31,
(in thousands)	2022		2021
Beginning balance	$	31,000	$	—
Measurement period adjustment		300		—
Change in fair value		753		—
Ending balance	$	32,053	$	—

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


(in thousands)	Fair Value at
Description	March 31, 2022		Level 1		Level 2		Level 3
Assets
Interest rate swap	$	431	$	—	$	431	$	—
Liabilities
Contingent consideration	$	32,053	$	—	$	—	$	32,053
CVRs	$	—	$	—	$	—	$	—


	Fair Value at
Description	December 31, 2021		Level 1		Level 2		Level 3
Liabilities
Contingent consideration	$	31,000	$	—	$	—	$	31,000
Interest rate swaps	$	6,790	$	—	$	6,790	$	—
CVRs	$	—	$	—	$	—	$	—

SEGMENT REPORTING (Tables)

3 Months Ended

Mar. 31, 2022

SEGMENT REPORTING

Schedule of revenue by reportable segments


	Three Months Ended
(in thousands)	March 31, 2022		March 31, 2021
Net Revenues
Generics, Established Brands, and Other	$	63,185	$	54,521
Rare Disease		1,292		—
Total net revenues	$	64,477	$	54,521

Segment earnings/(loss) before interest, taxes, depreciation and amortization ("EBITDA") and reconciliation to (loss)/income before income taxes
Generics, Established Brands, and Other		14,531		21,839
Rare Disease		(10,448)		(1,278)
Depreciation and amortization		(14,557)		(10,898)
Corporate and other unallocated expenses⁽¹⁾		(8,721)		(6,618)
Total operating (loss)/income	$	(19,195)	$	3,045

Interest expense, net		(6,613)		(2,454)
Other expense, net		(89)		(515)
(Loss)/income before benefit for income taxes	$	(25,897)	$	76

Schedule of revenue by geographic operations


(in thousands)	Three Months Ended March 31,
Location of Operations	2022		2021
United States	$	63,760	$	53,327
Canada		717		1,194
Total Revenue	$	64,477	$	54,521

Schedule of property and equipment by geographic location


(in thousands)	March 31, 2022		December 31, 2021
United States	$	38,770	$	38,564
Canada		13,685		13,831
India		258		276
Total property and equipment, net	$	52,713	$	52,671

REVENUE RECOGNITION AND RELATED ALLOWANCES - Disaggregation (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Revenue recognition	$ 64,477	$ 54,521
Sales of generic pharmaceutical products
Revenue recognition	49,107	32,988
Sales of established brand pharmaceutical products
Revenue recognition	8,452	7,517
Sales of rare disease pharmaceutical products
Revenue recognition	1,292
Sales of contract manufactured products
Revenue recognition	2,904	2,573
Royalties from licensing agreements
Revenue recognition	1,903	11,210
Product development services
Revenue recognition	566	158
Other
Revenue recognition	$ 253	$ 75

- 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=123359005&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=123359005&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=123359005&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=123359005&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=123359005&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=123351226&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=123359005&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=123359005&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=123359005&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=123351226&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 - Timing (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Revenue recognition	$ 64,477	$ 54,521
Performance obligations satisfied in prior periods	1,300	10,700
Deferred revenue	116		$ 87
Revenue recognized		100
Performance obligations transferred at a point in time
Revenue recognition	63,911	54,363
Performance obligations transferred over time
Revenue recognition	566	158
Maximum
Revenue recognized	$ 100
Tripartite Agreement-Yescart
Revenue recognition		$ 11,200

- Definition

+ References

+ Details

REVENUE RECOGNITION AND RELATED ALLOWANCES - Allowances (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Accruals and allowances
Beginning balance	$ 105,260
Ending balance	113,970
Chargebacks
Accruals and allowances
Beginning balance	94,066	$ 88,746
Accruals/Adjustments	152,566	96,701
Credits Taken Against Reserve	(142,991)	(114,114)
Ending balance	103,641	71,333
Government Rebates
Accruals and allowances
Beginning balance	5,492	7,826
Accruals/Adjustments	2,810	4,656
Credits Taken Against Reserve	(3,745)	(3,810)
Ending balance	4,557	8,672
Returns
Accruals and allowances
Beginning balance	35,831	27,155
Accruals/Adjustments	6,942	4,811
Credits Taken Against Reserve	(7,219)	(3,022)
Ending balance	35,554	28,944
Administrative Fees and Other Rebates
Accruals and allowances
Beginning balance	13,100	8,906
Accruals/Adjustments	9,785	7,634
Credits Taken Against Reserve	(10,915)	(9,184)
Ending balance	11,970	7,356
Prompt Payment Discounts
Accruals and allowances
Beginning balance	4,642	3,839
Accruals/Adjustments	5,060	3,196
Credits Taken Against Reserve	(4,539)	(3,959)
Ending balance	$ 5,163	$ 3,076

REVENUE RECOGNITION AND RELATED ALLOWANCES - Concentration (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Revenue recognition	$ 64,477	$ 54,521
Tripartite Agreement-Yescart
Revenue recognition		11,200
Payment for legal expenditures		400
Sales of contract manufactured products
Revenue, Remaining Performance Obligation, Amount	$ 6,200
Revenue, Remaining Performance Obligation, Remaining Period	6 months
Revenue recognition	$ 2,904	$ 2,573
Product Development Services
Revenue, Remaining Performance Obligation, Amount	$ 100
Revenue, Remaining Performance Obligation, Remaining Period	12 months
Customer concentration \| Revenue \| Customer one
Concentration Risk, Percentage	0.31%	0.28%
Customer concentration \| Revenue \| Customer two
Concentration Risk, Percentage	0.19%	0.24%
Customer concentration \| Revenue \| Customer three
Concentration Risk, Percentage	0.14%	0.16%

BUSINESS COMBINATION (Details) - Novitium $ / shares in Units, $ in Thousands		12 Months Ended
	Nov. 19, 2021 USD ($) $ / shares shares	Dec. 31, 2021 USD ($) shares	Mar. 31, 2022 USD ($)
Business acquisition
Shares issued in acquisition (in shares) \| shares	2,466,654	2,500,000
Closing stock price \| $ / shares	$ 43.54
Additional contingent consideration	$ 46,500		$ 46,500
Restriction period for shares issued	24 months
Business acquisition purchase consideration
Cash consideration	$ 88,076
Repayment of Novitium debts	8,493
Fair value of restricted shares	91,199
Fair value of contingent consideration in a business combination	30,800	$ 31,000	$ 32,053
Gross consideration	218,568
Cash acquired	12,076
Net consideration	$ 206,492
Minimum
Business acquisition
Restriction period for shares issued	3 months
Maximum
Business acquisition
Restriction period for shares issued	24 months
Measurement Input, Stock Volatility \| Minimum
Business acquisition purchase consideration
Unobservable inputs	65
Measurement Input, Stock Volatility \| Maximum
Business acquisition purchase consideration
Unobservable inputs	71
Measurement Input, Discounted Lack of Marketability \| Minimum
Business acquisition purchase consideration
Unobservable inputs	7.5
Measurement Input, Discounted Lack of Marketability \| Maximum
Business acquisition purchase consideration
Unobservable inputs	21.5

BUSINESS COMBINATION - Acquired (Details) - USD ($) $ in Thousands	Nov. 19, 2021	Mar. 31, 2022	Dec. 31, 2021
Goodwill		$ 28,188	$ 27,888
Novitium
Total Purchase Consideration	$ 218,568
Total purchase consideration	206,492
Cash and cash equivalents	12,076
Accounts receivable	27,185
Inventories	14,460
Prepaid expenses and other current assets	1,891
Property and equipment	14,331
Intangible assets	139,200
Goodwill	24,608
Other non-current assets	1,413
Total assets acquired	235,164
Accounts payable	1,560
Accrued expense and other current liabilities	6,035
Accrued compensation and other related expenses	4,909
Accrued government rebates	744
Returned goods reserve	2,202
Other non-current liabilities	1,146
Total liabilities assumed	16,596
Net assets acquired	218,568
Novitium \| Acquired ANDA intangible assets
Intangible assets	67,400
Novitium \| Customer relationships
Intangible assets	24,900
Novitium \| In process research and development
Intangible assets	$ 46,900

BUSINESS COMBINATION - Pro Forma (Details) - Novitium $ in Millions	3 Months Ended
	Mar. 31, 2022 USD ($)
Revenue since acquisition date	$ 19.2
Earnings (loss) since acquisition date	$ (0.2)

INDEBTEDNESS - Credit facility (Details) - USD ($) $ in Thousands	Nov. 19, 2021	Mar. 31, 2022	Dec. 31, 2021
Debt
Current debt		$ 850	$ 850
Term Facility
Debt
Debt, net of issuance costs		299,250
Credit Facility - 2021
Debt
Current debt		$ 3,000
Payments of debt issuance costs	$ 14,000
Credit Facility - 2021 \| Term Facility
Debt
Maximum borrowing capacity	300,000
Debt effective interest rate (as a percent)		6.75%
Quarterly payment	$ 750
Principal amount		$ 299,300
Credit Facility - 2021 \| Term Facility \| Alternative Base Rate
Debt
Basis spread (as a percent)	5.00%
Credit Facility - 2021 \| Term Facility \| LIBOR
Debt
Basis spread (as a percent)	6.00%
Credit Facility - 2021 \| Revolving Facility
Debt
Maximum borrowing capacity	$ 40,000
Remaining borrowing capacity		40,000
Commitment fee (as a percent)	0.50%
Deferred debt issuance costs		$ 1,000
Credit Facility - 2021 \| Revolving Facility \| Alternative Base Rate
Debt
Basis spread (as a percent)	3.75%
Credit Facility - 2021 \| Revolving Facility \| LIBOR
Debt
Basis spread (as a percent)	4.75%

INDEBTEDNESS - Facility components (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Current debt, net of deferred financing costs	$ 850	$ 850
Non-current debt, net of deferred financing costs and current component	286,307	286,520
Term Loan and DDTL
Current borrowing on debt	3,000	3,000
Deferred financing costs	(2,150)	(2,150)
Current debt, net of deferred financing costs	850	850
Non-current borrowing on debt	296,250	297,000
Deferred financing costs	(9,943)	(10,480)
Non-current debt, net of deferred financing costs and current component	286,307	$ 286,520
Credit Facility - 2021
Current debt, net of deferred financing costs	$ 3,000

INDEBTEDNESS - Outstanding (Details) - Credit Facility - 2021 $ in Millions	Mar. 31, 2022 USD ($)
Term Facility
Borrowing on debt	$ 299.3
Revolving Facility
Total debt issuance costs, net	1.0
Debt issuance costs, noncurrent	0.8
Debt issuance costs, current	$ 0.2

INDEBTEDNESS - Credit facility - Maturity (Details) - Term Facility $ in Thousands	Mar. 31, 2022 USD ($)
2022	$ 2,250
2023	3,000
2024	3,000
2025	3,000
2026	3,000
2027 and thereafter	285,000
Total	$ 299,250

- Definition

Amount, after unamortized (discount) premium and debt issuance costs, of long-term debt. Includes, but not limited to, notes payable, bonds payable, debentures, mortgage loans and commercial paper. Excludes capital lease obligations.

+ References + Details

INDEBTEDNESS - Interest (Details) - USD ($) $ in Thousands	3 Months Ended
INDEBTEDNESS - Interest (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Mar. 31, 2021
INDEBTEDNESS
Contractual coupon	$ 6,058	$ 2,304
Amortization of finance fees	591	177
Capitalized interest	(30)	(26)
Interest Expense, Debt	$ 6,619	$ 2,455

DERIVATIVE FINANCIAL INSTRUMENT AND HEDGING ACTIVITY (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021	Apr. 30, 2020
Fair value interest rate derivative assets	$ 431
Fair value interest rate derivative liabilities			$ 6,790
Accumulated other comprehensive loss, net of tax	(2,712)		$ 3,055
Derivative unrealized gain (loss) recorded in OCI	$ 5,767	$ 6,405
Credit Facility - 2021 \| Term Facility
Debt effective interest rate (as a percent)	6.75%
Interest rate swap
Derivative liability, notional amount	$ 162,200			$ 168,600
Debt effective interest rate (as a percent)				2.26%
Decrease in notional amount	4,000
Fair value interest rate derivative assets	400
Accumulated other comprehensive loss, net of tax	2,700
Derivative unrealized gain (loss)	6,900
Derivative unrealized gain (loss) recorded in OCI	5,800
Interest expense	1,000
Reclassifications out of accumulated other comprehensive income/loss	700	$ 900
Interest rate swap \| Credit Facility - 2021
Derivative liability, notional amount	$ 162,200

EARNINGS (LOSS) PER SHARE (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
EARNINGS (LOSS) PER SHARE
Net Loss (Income)	$ (20,130)	$ 86
Net income allocated to participating securities, basic		(5)
Net income allocated to participating securities, diluted		(5)
Dividends on Series A convertible preferred stock	(405)	0
Net (loss)/income available to common shareholders, Basic	(20,535)	81
Net (loss)/income available to common shareholders, Diluted	$ (20,535)	$ 81
Basic Weighted-Average Shares Outstanding	16,137	12,004
Dilutive effect of stock options and ESPP		13
Diluted Weighted-Average Shares Outstanding	16,137	12,017
(Loss)/Income per share, Basic	$ (1.27)	$ 0.01
(Loss)/Income per share, Diluted	$ (1.27)	$ 0.01

EARNINGS (LOSS) PER SHARE - Additional information (Details) - shares shares in Millions	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
EARNINGS (LOSS) PER SHARE
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	2.5	1.7

INVENTORIES (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
INVENTORIES
Raw materials	$ 52,816	$ 51,350
Packaging materials	5,560	5,475
Work-in-progress	615	652
Finished goods	31,363	31,969
Inventory, Gross, Total	90,354	89,446
Reserve for excess/obsolete inventories	(7,199)	(7,753)
Inventories, net	$ 83,155	$ 81,693

INVENTORIES - Concentration (Details) - Supplier concentration - One supplier	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Cost of goods sold
Concentration Risk, Percentage	16.00%	11.00%
Accounts payable
Concentration Risk, Percentage	0.00%

GOODWILL AND INTANGIBLE ASSETS - Goodwill (Details) - USD ($) $ in Thousands	3 Months Ended		12 Months Ended
	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021	Dec. 31, 2018	Dec. 31, 2013
Goodwill, impairment loss	$ 0	$ 0
BioSante Pharmaceuticals
Acquisition of goodwill					$ 1,800
WellSpring
Acquisition of goodwill				$ 1,700
Novitium
Acquisition of goodwill			$ 24,600

GOODWILL AND INTANGIBLE ASSETS - Components (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Definite-Lived Intangible Assets:
Accumulated Amortization	$ (218,916)		$ (206,367)
Weighted Average Amortization Period	9 years
Indefinite-Lived Intangible Assets:
Gross Carrying Amount, total	$ 500,489		500,489
Amortization of intangible assets	12,500	$ 9,700
Intangible asset impairment charge	$ 0	$ 0
Minimum
Definite-Lived Intangible Assets:
Weighted Average Amortization Period	7 years
Maximum
Definite-Lived Intangible Assets:
Weighted Average Amortization Period	10 years
In process research and development
Indefinite-Lived Intangible Assets:
Gross Carrying Amount	$ 46,900		46,900
Acquired ANDA intangible assets
Definite-Lived Intangible Assets:
Gross Carrying Amount	168,536		168,536
Accumulated Amortization	$ (59,127)		(54,079)
Weighted Average Amortization Period	8 years 6 months
NDAs and product rights
Definite-Lived Intangible Assets:
Gross Carrying Amount	$ 242,372		242,372
Accumulated Amortization	$ (145,184)		(138,835)
Weighted Average Amortization Period	9 years 10 months 24 days
Marketing and distribution rights
Definite-Lived Intangible Assets:
Gross Carrying Amount	$ 17,157		17,157
Accumulated Amortization	$ (12,588)		(12,347)
Weighted Average Amortization Period	5 years 6 months
Non-compete agreement
Definite-Lived Intangible Assets:
Gross Carrying Amount	$ 624		624
Accumulated Amortization	$ (535)		(513)
Weighted Average Amortization Period	7 years
Customer relationships
Definite-Lived Intangible Assets:
Gross Carrying Amount	$ 24,900		24,900
Accumulated Amortization	$ (1,482)		$ (593)
Weighted Average Amortization Period	7 years

GOODWILL AND INTANGIBLE ASSETS - Amortization (Details) $ in Thousands	Mar. 31, 2022 USD ($)
GOODWILL AND INTANGIBLE ASSETS
2022 (remainder of the year)	$ 36,572
2023	50,792
2024	49,997
2025	47,893
2026	34,574
2027 and thereafter	61,745
Total	$ 281,573

MEZZANINE AND STOCKHOLDERS' EQUITY (Details) $ / shares in Units, $ in Millions			12 Months Ended
	Nov. 19, 2021 USD ($) D $ / shares shares	Mar. 08, 2021 USD ($) $ / shares shares	Dec. 31, 2021 shares	Mar. 31, 2022 $ / shares shares	Mar. 31, 2021 $ / shares
Preferred Stock, Shares Authorized			1,666,667	1,666,667
Preferred Stock, Par or Stated Value Per Share (in dollars per share) \| $ / shares				$ 0.0001	$ 0.0001
Convertible Preferred Stock
Convertible preferred stock outstanding (shares)			25,000	25,000
PIPE Shares [Member] \| Convertible Preferred Stock
Temporary stock issued (in shares)	25,000	25,000
Temporary stock issued (in dollars per share) \| $ / shares	$ 1,000	$ 1,000
Temporary stock issued, value \| $	$ 25.0	$ 25.0
Cash paid for costs of share issuances \| $	$ 0.2
Shares accrue dividends rate	6.50%
Shares conversion price \| $ / shares	$ 41.47
Threshold number of trading days \| D	20
Number of consecutive trading days \| D	30
Maximum percentage of conversion price	1.70%
Convertible, shares issuable				602,901
Common Stock
Common Stock, Authorized Shares				33,300,000
Common Stock, Par Value (in dollars per share) \| $ / shares				$ 0.0001
Common Stock, Shares, Issued			16,900,000	17,400,000
Common Stock, Shares, Outstanding			16,900,000	17,300,000
Issuance of Common Stock in Public Offering (in shares)			1,500,000
Class C Special Stock
Common Stock, Authorized Shares				800,000
Common Stock, Par Value (in dollars per share) \| $ / shares				$ 0.0001
Common Stock, Shares, Issued				11,000
Common Stock, Shares, Outstanding				11,000
Common Stock Conversion Price \| $ / shares				$ 90.00
Novitium
Shares issued in acquisition (in shares)	2,466,654		2,500,000

STOCK-BASED COMPENSATION - Expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Employee Stock Purchase Plan 2016 [Member]
Stock-based compensation shares available	200,000
Discount from market price (as a percent)	15.00%
Allocated share-based compensation expense	$ 38	$ 32
Stock Incentive Plan
Stock-based compensation shares available	100,000
Stock-based compensation additional shares authorized	1,150,000
Allocated share-based compensation expense	$ 3,199	1,837
Cost of sales [Member] \| Employee Stock Purchase Plan 2016 [Member]
Allocated share-based compensation expense	10	4
Cost of sales [Member] \| Stock Incentive Plan
Allocated share-based compensation expense	135
Research and development Expense [Member] \| Employee Stock Purchase Plan 2016 [Member]
Allocated share-based compensation expense	7	5
Research and development Expense [Member] \| Stock Incentive Plan
Allocated share-based compensation expense	246	114
Selling, general and administrative Expenses [Member] \| Employee Stock Purchase Plan 2016 [Member]
Allocated share-based compensation expense	21	23
Selling, general and administrative Expenses [Member] \| Stock Incentive Plan
Allocated share-based compensation expense	$ 2,818	$ 1,723

STOCK-BASED COMPENSATION - Stock option activity (Details) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Option Shares
Proceeds from stock option exercises and ESPP purchases	$ 3	$ 0
Options [Member]
Option Shares
Outstanding at the beginning of the period (in shares)	747	756
Granted (in shares)	27	42
Forfeited (in shares)		(10)
Outstanding at the end of the period (in shares)	774	788
Inducement Grants [Member]
Option Shares
Outstanding at the beginning of the period (in shares)	241	180
Granted (in shares)		61
Outstanding at the end of the period (in shares)	241	241

STOCK-BASED COMPENSATION - RSA activity (Details) - Restricted Stock [Member] - shares shares in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Unvested, Shares, Outstanding, Beginning of period	707	352
Unvested Shares, Granted	460	438
Unvested Shares, Vested	(161)	(34)
Unvested Shares, Forfeited		(38)
Unvested Shares, Outstanding, End of period	1,006	718

STOCK-BASED COMPENSATION - Additional information (Details) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Treasury stock value	$ 4,253		$ 3,135
Restricted Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares purchased from employees	40	10
Treasury stock value	$ 1,100	$ 348

INCOME TAXES - Quarter (Details) - USD ($) $ in Thousands	3 Months Ended
INCOME TAXES - Quarter (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Mar. 31, 2021
Valuation allowance	$ 400
Provision (benefit) for income taxes	$ (5,767)	$ (10)
Effective income tax rate (as a percent)	22.30%	27.70%
Pre-tax consolidated loss	$ (25,897)	$ 76
Maximum
Provision (benefit) for income taxes		$ (100)

- 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
-Paragraph 32
-Subparagraph (c)
-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8933-108599

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=123359005&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=123359005&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=123384075&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=123359005&loc=d3e8736-108599

Reference 6: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 220
-SubTopic 10
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Reference 7: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
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-Topic 944
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-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(8))
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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))
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Reference 9: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 280
-SubTopic 10
-Section 50
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-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e8924-108599

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 942
-SubTopic 220
-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
	Mar. 31, 2022	Mar. 31, 2021
Operating lease, weighted average remaining lease term	2 years 10 months 24 days
Operating lease costs	$ 126	$ 49
Variable lease costs	66	7
Total lease costs	$ 192	$ 56
Minimum
Operating lease liability discount rates (in percent)	3.99%
Maximum
Operating lease liability discount rates (in percent)	8.95%

COMMITMENTS AND CONTINGENCIES - Lease maturity (Details) $ in Thousands	Mar. 31, 2022 USD ($)
COMMITMENTS AND CONTINGENCIES
2022	$ 344
2023	428
2024	412
2025	190
2026 and thereafter	51
Total	1,425
Discount	(143)
Lease liability	1,282
Current lease liability	$ (380)
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Accrued Liabilities, Current
Non-current lease liability	$ 902

COMMITMENTS AND CONTINGENCIES (Details) - USD ($) $ in Thousands			3 Months Ended
	Feb. 15, 2022	Aug. 03, 2021	Mar. 31, 2022	Mar. 31, 2021
COMMITMENTS AND CONTINGENCIES
Revenue recognition			$ 64,477	$ 54,521
Arbor Pharmaceuticals [Member]
COMMITMENTS AND CONTINGENCIES
Settlement amount awarded to other party		$ 8,400
Azurity Pharmaceuticals [Member]
COMMITMENTS AND CONTINGENCIES
Settlement amount awarded to other party	$ 1,900
Unapproved Products [Member]
COMMITMENTS AND CONTINGENCIES
Revenue recognition			4,000	3,800
Unapproved Products [Member] \| Contract Customer [Member]
COMMITMENTS AND CONTINGENCIES
Revenue recognition			$ 600	$ 800

- Definition

+ References

+ Details

FAIR VALUE DISCLOSURES - Level 3 (Details) $ in Thousands	3 Months Ended
FAIR VALUE DISCLOSURES - Level 3 (Details) $ in Thousands	Mar. 31, 2022 USD ($)	Nov. 19, 2021 USD ($)
Changes in contingent consideration
Level 3 liability, beginning balance	$ 31,000
Measurement period adjustment	300
Change in fair value	753
Level 3 liability, ending balance	$ 32,053
Discount rate \| Profit-based milestone payments
Unobservable inputs	12.3
Discount rate \| Product development-based milestone payments
Unobservable inputs	10.0
Probability of payment \| Product development-based milestone payments
Unobservable inputs	90.0
Contingent Value Rights \| Discount rate
Unobservable inputs	15
Novitium
Additional contingent consideration	$ 46,500	$ 46,500

FAIR VALUE DISCLOSURES - Hierarchy (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021	Nov. 19, 2021
Interest rate swaps, asset	$ 431
Interest rate swaps, liability		$ 6,790
Fair Value, Inputs, Level 2 [Member]
Interest rate swaps, asset	431
Interest rate swaps, liability		6,790
Novitium
Contingent consideration	32,053	31,000	$ 30,800
Novitium \| Fair Value, Inputs, Level 3 [Member]
Contingent consideration	$ 32,053	$ 31,000

FAIR VALUE DISCLOSURES - Acquired (Details) $ in Thousands	1 Months Ended	3 Months Ended
FAIR VALUE DISCLOSURES - Acquired (Details) $ in Thousands	Apr. 30, 2021 USD ($)	Mar. 31, 2022 USD ($)	Mar. 31, 2021 USD ($)	Dec. 31, 2021 USD ($)
Intangible asset impairment charge		$ 0	$ 0
Payments to acquire intangible assets		$ 229	39
Useful life of intangible assets		9 years
Research and development		$ 5,274	2,968
Amortization of intangible assets		12,500	$ 9,700
Inventories, net		83,155		$ 81,693
Raw materials		52,816		51,350
Finished goods		$ 31,363		31,969
Minimum
Useful life of intangible assets		7 years
Maximum
Useful life of intangible assets		10 years
Acquired ANDA intangible assets
Finite-lived intangible gross carrying amount		$ 168,536		168,536
Useful life of intangible assets		8 years 6 months
Marketing and distribution rights
Finite-lived intangible gross carrying amount		$ 17,157		$ 17,157
Useful life of intangible assets		5 years 6 months
Sandoz Inc [Member]
Intangible asset impairment charge		$ 0
Total asset purchase	$ 20,700
Transaction costs	400
Finite-lived intangible gross carrying amount	$ 11,400
Useful life of intangible assets	7 years
Inventories, net	$ 9,700
Raw materials	600
Sample inventory	1,000
Finished goods	$ 8,100
Sandoz Inc [Member] \| Discount rate
Intangible asset measurement input	10

PURIFIED CORTROPHIN GEL PRE-LAUNCH CHARGES (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
PURIFIED CORTROPHIN GEL PRE-LAUNCH CHARGES
Purified Cortrophin Gel pre-launch charges	$ 0	$ 38

RELATED PARTY TRANSACTIONS (Details) - USD ($) $ / shares in Units, $ in Millions			3 Months Ended
	Nov. 19, 2021	Mar. 08, 2021	Mar. 31, 2022
Related Party Transaction [Line Items]
Due to related parties			$ 0.1
Convertible Preferred Stock \| PIPE Shares [Member]
Related Party Transaction [Line Items]
Temporary stock issued (in shares)	25,000	25,000
Temporary stock issued (in dollars per share)	$ 1,000	$ 1,000
Temporary stock issued, value	$ 25.0	$ 25.0
Esjay
Related Party Transaction [Line Items]
Due to related parties			0.0
SS Pharma
Related Party Transaction [Line Items]
Payments to related party			1.0
Due to related parties			0.0
Nuray
Related Party Transaction [Line Items]
Payments to related party			0.9
Due to related parties			0.0
Scitus
Related Party Transaction [Line Items]
Payments to related party			$ 0.6

SEGMENT REPORTING - Revenue (Details) $ in Thousands	3 Months Ended		12 Months Ended
SEGMENT REPORTING - Revenue (Details) $ in Thousands	Mar. 31, 2022 USD ($) segment	Mar. 31, 2021 USD ($)	Dec. 31, 2021 segment
Segment reporting
Number of segments \| segment	2		1
Revenue recognition	$ 64,477	$ 54,521
Depreciation and amortization	14,557	10,898
Selling, general, and administrative	28,817	17,587
Operating (Loss)/Income	(19,195)	3,045
Interest expense, net	(6,613)	(2,454)
Other expense, net	(89)	(515)
(Loss)/Income Before Benefit for Income Taxes	(25,897)	76
Operating segments \| Generics, Established Brands and Other
Segment reporting
Revenue recognition	63,185	54,521
EBITDA	14,531	21,839
Operating segments \| Rare Disease
Segment reporting
Revenue recognition	1,292
EBITDA	(10,448)	(1,278)
Unallocated expenses
Segment reporting
Depreciation and amortization	(14,557)	(10,898)
Selling, general, and administrative	(8,721)	(6,618)
Operating (Loss)/Income	(19,195)	3,045
Interest expense, net	(6,613)	(2,454)
Other expense, net	$ (89)	$ (515)

SEGMENT REPORTING - Geographic (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Segment reporting
Revenue recognition	$ 64,477	$ 54,521
Property and equipment, net	52,713		$ 52,671
United States
Segment reporting
Revenue recognition	63,760	53,327
Property and equipment, net	38,770		38,564
Canada
Segment reporting
Revenue recognition	717	$ 1,194
Property and equipment, net	13,685		13,831
India
Segment reporting
Property and equipment, net	$ 258		$ 276

- Definition

+ References

+ Details