ANI PHARMACEUTICALS INC 10-K

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Stockholders of ANI Pharmaceuticals, Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of ANI Pharmaceuticals, Inc. and Subsidiaries (the “Company”) as of December 31, 2023 and 2022, and the related consolidated statements of operations, comprehensive income (loss), mezzanine equity and stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2023 and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2023 and 2022, and the consolidated results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the Company’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control - Integrated Framework ( 2013 ) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”), and our report dated February 29, 2024 expressed an unqualified opinion. Basis for Opinion These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matter The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates. Evaluation of Certain Assumptions impacting the Chargeback Accrual As described in Note 2 to the consolidated financial statements, the Company records certain variable consideration including discounts, which are estimated at the time of sale generally using the expected value method. Amounts accrued for chargebacks as of December 31, 2023, are approximately $84.2 million and are evaluated on a quarterly basis. Management’s estimate of chargebacks is based on the inventory levels in the distribution channel as provided by wholesalers, as well as the actual average selling price for each product which is impacted by changes in customer mix, changes in negotiated terms with customers, changes in the volume of off-contract purchases, and changes in the wholesaler acquisition cost, in order to estimate the expected provision. 62 Table of Contents The principal consideration for our determination that performing procedures relating to the chargeback reserve is a critical audit matter is that there was a significant judgment required by management with respect to measure uncertainty, as the calculation of the chargeback reserve includes assumptions such as average selling price, purchasing trends of distributors and historical product sales used to predict future sales. This in turn led to a high degree of auditor judgment, subjectivity and effort in applying the procedures related to those assumption. Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included assessing the design and testing the effectiveness of controls relating to the chargeback reserve, including management’s control over the assumptions used to estimate the corresponding accruals. We recalculated the chargeback accrual for a selection of products, based on a combination of Company internal data, historical accrual by recalculating the accrual using our independent assumptions. We evaluated the Company’s ability to accurately estimate the accrual for chargebacks by comparing historically recorded accruals to the actual amount that was ultimately claimed by the wholesalers. We analyzed year over year trends in the reserve in comparison with revenue trends to further evaluate reasonableness of the estimate and consistency with expectations. /s/ EisnerAmper LLP We have served as the Company’s auditor since 2013. EISNERAMPER LLP Philadelphia, Pennsylvania February 29, 2024 63 Table of Contents REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Stockholders of ANI Pharmaceuticals, Inc. Opinion on the Internal Control over Financial Reporting We have audited ANI Pharmaceuticals, Inc. and Subsidiaries (the “Company”) internal control over financial reporting as of December 31, 2023 based on criteria established in the Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as December 31, 2023, based on criteria established in the Internal Control - Integrated Framework ( 2013 ) issued by COSO. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the consolidated balance sheets of ANI Pharmaceuticals, Inc. and Subsidiaries as of December 31, 2023 and 2022, and the related consolidated statements of operations, comprehensive income (loss), mezzanine equity and stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2023 and the related notes and our report dated February 29, 2024 expressed an unqualified opinion. Basis for Opinion The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion. Definition and Limitations of Internal Control over Financial Reporting An entity’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. An entity’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the entity; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the entity are being made only in accordance with authorizations of management and directors of the entity; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the entity’s assets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. /s/ EisnerAmper LLP EISNERAMPER LLP Philadelphia, Pennsylvania February 29, 2024 64 Table of Contents ANI PHARMACEUTICALS, INC. AND SUBSIDIARIES Consolidated Balance Sheets (in thousands, except share and per share amounts) December 31, 2023 December 31, 2022 Assets Current Assets Cash and cash equivalents $ 221,121 $ 48,228 Current restricted cash — 5,006 Accounts receivable, net of $ 97,262 and $ 161,052 of adjustments for chargebacks and other allowances at December 31, 2023 and 2022, respectively 162,079 165,438 Inventories 111,196 105,355 Prepaid income taxes — 3,827 Assets held for sale 8,020 8,020 Prepaid expenses and other current assets 17,400 8,387 Total Current Assets 519,816 344,261 Non-current Assets Property and equipment, net 44,593 43,246 Deferred tax assets, net of deferred tax liabilities and valuation allowance 90,711 81,363 Intangible assets, net 209,009 251,635 Goodwill 28,221 28,221 Derivatives and other non-current assets 12,072 11,361 Total Assets $ 904,422 $ 760,087 Liabilities, Mezzanine Equity, and Stockholders’ Equity Current Liabilities Current debt, net of deferred financing costs $ 850 $ 850 Accounts payable 36,683 29,305 Accrued royalties 16,276 9,307 Accrued compensation and related expenses 23,786 10,312 Accrued government rebates 12,168 10,872 Income taxes payable 8,164 — Returned goods reserve 29,678 33,399 Current contingent consideration 12,266 — Accrued expenses and other 5,606 5,394 Total Current Liabilities 145,477 99,439 Non-current Liabilities Non-current debt, net of deferred financing costs and current component 284,819 285,669 Non-current contingent consideration, net of current 11,718 35,058 Other non-current liabilities 4,809 1,381 Total Liabilities $ 446,823 $ 421,547 Commitments and Contingencies (Note 15) Mezzanine Equity Convertible Preferred Stock, Series A, $ 0.0001 par value, 1,666,667 shares authorized; 25,000 shares issued and outstanding at December 31, 2023 and 2022 24,850 24,850 Stockholders’ Equity Common Stock, $ 0.0001 par value, 33,333,334 shares authorized; 20,730,896 shares issued and 20,466,953 outstanding at December 31, 2023; 17,643,497 shares issued and 17,494,466 shares outstanding at December 31, 2022 2 1 Class C Special Stock, $ 0.0001 par value, 781,281 shares authorized; 10,864 shares issued and outstanding at December 31, 2023 and 2022 respectively — — Preferred Stock, $ 0.0001 par value, 1,666,667 shares authorized; 0 shares issued and outstanding at December 31, 2023 and 2022, respectively — — Treasury stock, 263,943 shares of common stock, at cost, at December 31, 2023 and 149,031 shares of common stock, at cost, at December 31, 2022 ( 10,081 ) ( 5,094 ) Additional paid-in capital 514,103 403,901 Accumulated deficit ( 80,132 ) ( 97,286 ) Accumulated other comprehensive income, net of tax 8,857 12,168 Total Stockholders’ Equity 432,749 313,690 Total Liabilities, Mezzanine Equity, and Stockholders’ Equity $ 904,422 $ 760,087 The accompanying notes are an integral part of these consolidated financial statements. 65 Table of Contents ANI PHARMACEUTICALS, INC. AND SUBSIDIARIES Consolidated Statements of Operations (in thousands, except per share amounts) Years Ended December 31, 2023 2022 2021 Net Revenues $ 486,816 $ 316,385 $ 216,136 Operating Expenses Cost of sales (excluding depreciation and amortization) 181,513 138,785 100,610 Research and development 34,286 22,318 11,369 Selling, general, and administrative 161,697 124,044 84,294 Depreciation and amortization 59,791 56,972 47,252 Contingent consideration fair value adjustment 1,426 3,758 500 Legal settlement expense — — 8,750 Purified Cortrophin Gel pre-launch charges — — 780 Restructuring activities 1,132 5,679 — Intangible asset impairment charge — 112 2,374 Total Operating Expenses 439,845 351,668 255,929 Operating Income (Loss) 46,971 ( 35,283 ) ( 39,793 ) Other Expense, net Interest expense, net ( 26,940 ) ( 28,052 ) ( 11,922 ) Other (expense) income, net ( 159 ) 670 ( 4,343 ) Income (Loss) Before Expense (Benefit) for Income Taxes 19,872 ( 62,665 ) ( 56,058 ) Income tax expense (benefit) 1,093 ( 14,769 ) ( 13,455 ) Net Income (Loss) $ 18,779 $ ( 47,896 ) $ ( 42,603 ) Dividends on Series A Convertible Preferred Stock $ ( 1,625 ) $ ( 1,625 ) $ ( 190 ) Net Income (Loss) Available to Common Shareholders $ 17,154 $ ( 49,521 ) $ ( 42,793 ) Basic and Diluted Income (Loss) Per Share: Basic Income (Loss) Per Share $ 0.86 $ ( 3.05 ) $ ( 3.40 ) Diluted Income (Loss) Per Share $ 0.85 $ ( 3.05 ) $ ( 3.40 ) Basic Weighted-Average Shares Outstanding 18,001 16,260 12,596 Diluted Weighted-Average Shares Outstanding 18,194 16,260 12,596 The accompanying notes are an integral part of these consolidated financial statements. 66 Table of Contents ANI PHARMACEUTICALS, INC. AND SUBSIDIARIES Consolidated Statements of Comprehensive Income (Loss) (in thousands) Years Ended December 31, 2023 2022 2021 Net income (loss) $ 18,779 $ ( 47,896 ) $ ( 42,603 ) Other comprehensive (loss) income, net of tax: Foreign currency translation adjustment 44 ( 112 ) 12 (Loss) gain on interest rate swap ( 3,355 ) 15,335 8,370 Total other comprehensive (loss) income, net of tax ( 3,311 ) 15,223 8,382 Total comprehensive income (loss), net of tax $ 15,468 $ ( 32,673 ) $ ( 34,221 ) The accompanying notes are an integral part of these consolidated financial statements. 67 Table of Contents ANI PHARMACEUTICALS, INC. AND SUBSIDIARIES Consolidated Statements of Changes in Mezzanine Equity and Stockholders’ Equity For the Years Ended December 31, 2023, 2022, and 2021 (in thousands) Mezzanine Equity Series A Convertible Preferred Stock Mezzanine Equity Series A Convertible Preferred Stock Shares Common Stock Par Value Common Stock Shares Class C Special Stock Additional Paid-in Capital Treasury Stock Shares Treasury Stock Accumulated Other Comprehensive (Loss) Gain Net of Tax Accumulated Deficit Total Mezzanine Equity and Stockholders' Equity Balance, December 31, 2020 $ — — $ 1 12,430 $ — $ 214,354 76 $ ( 2,246 ) $ ( 11,437 ) $ ( 4,972 ) $ 195,700 Stock-based Compensation Expense — — — — — 10,489 — — — — 10,489 Treasury Stock Purchases for Restricted Stock Vests — — — — — — 28 ( 889 ) — — ( 889 ) Issuance of Common Shares upon Stock Option and ESPP Exercise — — — 56 — 2,069 — — — — 2,069 Issuance of Restricted Stock Awards — — — 541 — — — — — — — Restricted Stock Awards Forfeitures — — — ( 81 ) — ( 1 ) ( 21 ) — — — ( 1 ) Issuance of Common Stock for Novitium Acquisition — — — 2,467 — 91,199 — — — 91,199 Issuance of Common Stock in Public Offering — — — 1,500 — 69,734 — — — — 69,734 Dividends on Convertible Preferred Stock — — — — — — — — — ( 190 ) ( 190 ) Issuance of Series A Convertible Preferred Stock from Mezzanine Equity 24,850 25 — — — — — — — — 24,850 Other comprehensive income — — — — — — — — 8,382 — 8,382 Net Loss — — — — — — — — — ( 42,603 ) ( 42,603 ) Balance, December 31, 2021 $ 24,850 25 $ 1 16,913 $ — $ 387,844 83 $ ( 3,135 ) $ ( 3,055 ) $ ( 47,765 ) $ 358,740 Stock-based Compensation Expense — — — — — 14,599 — — — — 14,599 Treasury Stock Purchases for Restricted Stock Vests — — — — — — 66 ( 1,959 ) — — ( 1,959 ) Issuance of Common Shares upon Stock Option and ESPP Exercise — — — 52 — 1,458 — — — — 1,458 Issuance of Restricted Stock Awards — — — 748 — — — — — — — Restricted Stock Awards Forfeitures — — — ( 69 ) — — — — — — — Dividends on Convertible Preferred Stock — — — — — — — — — ( 1,625 ) ( 1,625 ) Other comprehensive income — — — — — — — — 15,223 — 15,223 Net Loss — — — — — — — — — ( 47,896 ) ( 47,896 ) Balance, December 31, 2022 $ 24,850 25 $ 1 17,644 $ — $ 403,901 149 $ ( 5,094 ) $ 12,168 $ ( 97,286 ) $ 338,540 Stock-based Compensation Expense — — — — — 20,652 — — — — 20,652 Treasury Stock Purchases for Restricted Stock Vests — — — — — — 115 ( 4,987 ) — — ( 4,987 ) Issuance of Common Shares upon Stock Option and ESPP Exercise — — — 227 — 8,996 — — — — 8,996 Issuance of Restricted Stock Awards — — — 674 — — — — — — — Issuance of Performance Stock Units — — — 85 — — — — — — — 68 Table of Contents Restricted Stock Awards and Performance Stock Units Forfeitures — — — ( 83 ) — ( 1 ) — — — — ( 1 ) Issuance of Common Stock in Public Offering, net of offering costs — — 1 2,184 — 80,555 — — — — 80,556 Dividends on Convertible Preferred Stock — — — — — — — — — ( 1,625 ) ( 1,625 ) Other comprehensive loss — — — — — — — — ( 3,311 ) — ( 3,311 ) Net Income — — — — — — — — — 18,779 18,779 Balance, December 31, 2023 $ 24,850 25 $ 2 20,731 $ — $ 514,103 264 $ ( 10,081 ) $ 8,857 $ ( 80,132 ) $ 457,599 The accompanying notes are an integral part of these consolidated financial statements. 69 Table of Contents ANI PHARMACEUTICALS, INC. AND SUBSIDIARIES Consolidated Statements of Cash Flows (in thousands) Year Ended December 31, 2023 2022 2021 Cash Flows From Operating Activities Net income (loss) $ 18,779 $ ( 47,896 ) $ ( 42,603 ) Adjustments to reconcile net income (loss) to net cash and cash equivalents provided by (used in) operating activities: Stock-based compensation 20,652 14,599 10,489 Deferred taxes ( 11,740 ) ( 15,253 ) ( 16,754 ) Depreciation and amortization 59,791 59,653 47,252 Acquired in-process research and development ("IPR&D") — 1,151 — Non-cash operating lease expense 1,269 — — Non-cash interest 3,922 3,961 2,512 Contingent consideration fair value adjustment 1,426 4,058 500 Loss on extinguishment of debt — — 1,458 Asset impairment charges — 574 2,374 Gain on sale of ANDAs — ( 750 ) ( 1,822 ) Changes in operating assets and liabilities, net of acquisition (2021): Accounts receivable, net 3,359 ( 36,912 ) ( 5,548 ) Inventories ( 5,841 ) ( 23,626 ) 3,224 Prepaid expenses and other current assets ( 9,015 ) ( 798 ) 127 Accounts payable 7,552 5,038 10,166 Accrued royalties 6,969 3,082 ( 267 ) Current income taxes payable, net 11,991 ( 160 ) ( 7,573 ) Accrued government rebates 1,296 5,380 ( 3,078 ) Returned goods reserve ( 3,722 ) ( 2,399 ) 6,503 Accrued expenses, accrued compensation, and other 12,271 ( 905 ) ( 3,638 ) Net Cash and Cash Equivalents Provided by (Used in) Operating Activities 118,959 ( 31,203 ) 3,322 Cash Flows From Investing Activities Acquisition of Novitium Pharma LLC, net of cash acquired — ( 33 ) ( 84,494 ) Acquisition of product rights, IPR&D, and other related assets ( 9,643 ) ( 7,579 ) ( 21,081 ) Acquisition of property and equipment, net ( 8,868 ) ( 8,876 ) ( 2,557 ) Proceeds from the sale of long-lived assets — 750 2,649 Net Cash and Cash Equivalents Used in Investing Activities ( 18,511 ) ( 15,738 ) ( 105,483 ) Cash Flows From Financing Activities Proceeds from public offering, net of transaction expenses 80,555 — 69,584 Payments on contingent consideration ( 12,500 ) — — Payments on Term Loan and Delayed Draw Term Loan agreements — — ( 10,862 ) Payments on borrowings under credit agreements ( 3,000 ) ( 3,000 ) — Borrowings under Prior Revolver agreement — — 24,000 Repayment of Prior Credit Facility — — ( 200,148 ) Borrowings under the Credit Facility, net of issuance costs — — 286,032 Proceeds from issuance of convertible preferred stock — — 25,000 Series A convertible preferred stock dividends paid ( 1,625 ) ( 1,625 ) ( 190 ) Proceeds from stock option exercises and ESPP purchases 8,996 1,458 2,069 Treasury stock purchases for restricted stock vests ( 4,987 ) ( 1,959 ) ( 890 ) Net Cash and Cash Equivalents Provided by (Used in) Financing Activities 67,439 ( 5,126 ) 194,595 Net Change in Cash and Cash Equivalents 167,887 ( 52,067 ) 92,434 Cash and cash equivalents, beginning of year 53,234 105,301 12,867 Cash and cash equivalents, end of year $ 221,121 $ 53,234 $ 105,301 70 Table of Contents Year Ended December 31, 2023 2022 2021 Reconciliation of cash, cash equivalents, and restricted cash, beginning of year Cash and cash equivalents 48,228 100,300 7,864 Restricted cash 5,006 5,001 5,003 Cash, cash equivalents, and restricted cash, beginning of year $ 53,234 $ 105,301 $ 12,867 Reconciliation of cash, cash equivalents, and restricted cash, end of year Cash and cash equivalents 221,121 48,228 100,300 Restricted cash — 5,006 5,001 Cash, cash equivalents, and restricted cash, end of year $ 221,121 $ 53,234 $ 105,301 Supplemental disclosure for cash flow information: Cash paid for interest, net of amounts capitalized $ 31,431 $ 21,477 $ 9,705 Cash paid for income taxes $ 1,228 $ 288 $ 10,371 Right-of-use assets obtained in exchange for lease obligations $ 4,715 $ — $ — Supplemental non-cash investing and financing activities: Fair value of contingent consideration in a business combination $ — $ — $ 30,500 Fair value of equity issued as consideration in a business combination $ — $ — $ 91,199 Acquisition of product rights included in accounts payable $ — $ 1,000 $ — Property and equipment purchased and included in accounts payable $ 328 $ 452 $ 152 The accompanying notes are an integral part of these consolidated financial statements. 71 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 1. DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Organization and Business 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. The team is focused on delivering growth by scaling up the Rare Disease business through the successful launch of its lead asset, Cortrophin Gel, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. The Company owns and operates three pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota, and one is located in East Windsor, New Jersey, 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. The Company has ceased operations at the Oakville, Ontario, manufacturing facility as of March 31, 2023. This action was part of ongoing initiatives to capture operational synergies following the acquisition of Novitium Pharma LLC (“Novitium”) in November 2021. The Company has fully completed the transition of the products manufactured or packaged at Oakville to one of the three U.S.-based manufacturing sites. On November 6, 2023, ANI Pharmaceuticals Canada Inc., a wholly owned subsidiary of the Company, entered into an agreement for the sale of the Oakville, Ontario manufacturing facility, however, the agreement was subsequently terminated in December 2023 by mutual agreement. In February 2024, the Company entered into an agreement for the purchase and sale of the Oakville site, for a purchase price of 19.2 million Canadian Dollars, or approximately $ 14.2 million US Dollars, based on the current exchange rate. The sale is expected to close in March 2024 (Note 19). Basis of Presentation The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Principles of Consolidation The consolidated financial statements include the accounts of ANI Pharmaceuticals, Inc. and its subsidiaries. All intercompany accounts and transactions are eliminated in consolidation. Foreign Currency The Company has ceased operations at our subsidiary in Oakville, Ontario, Canada as of March 31, 2023. The Company currently has a subsidiary located in India. The Canada-based subsidiary conducted its transactions in U.S. dollars and Canadian dollars, but its functional currency was 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. The gain or loss on transactions denominated in foreign currencies and the translation impact of local currencies to U.S. dollars was immaterial for the years ended December 31, 2023, 2022, and 2021. Unless otherwise noted, all references to “$” or “dollar” refer to the U.S. dollar. The Company’s asset and liability accounts are translated using the current exchange rate as of the balance sheet date, except for shareholders’ equity accounts, intercompany, and fixed assets, which are translated using historical rates. Net revenues and expense accounts are translated using an average exchange rate over the period ended on the balance sheet date. Adjustments resulting from the translation of the financial statements of the Company’s foreign subsidiaries into U.S. dollars are accumulated as a separate component of shareholders’ equity within accumulated other comprehensive income (loss), net of tax. 72 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Use of Estimates The preparation of the Company’s financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. In the 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 potential adjustments, income tax expense or benefit, deferred taxes and valuation allowance, stock-based compensation, 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, and the depreciable lives of long-lived assets. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from such estimates. Because of the uncertainties inherent in such estimates, actual results may differ from those estimates. Restructuring Activities The Company defines restructuring activities to include costs directly associated with exit or disposal activities. Such costs include cash employee contractual severance and other termination benefits, one-time employee termination severance and benefits, contract termination charges, impairment and acceleration of depreciation associated with long-lived assets, and other exit or disposal costs. In general, we record involuntary employee- related exit and disposal costs when there is a substantive plan for employee severance and related payments are probable and estimable. For one-time termination benefits, including those with a service requirement, expense is recorded when the employees are entitled to receive such benefits and the amount can be reasonably estimated. Expense related to one-time termination benefits with a service requirement is recorded over time, as the service is completed. Contract termination fees and penalties, and other exit and disposal costs are generally recorded as incurred. Restructuring activities are recognized as an operating expense in the consolidated statements of operations. Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers . Revenue is recognized 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. The Company derives its revenues primarily from sales of generic, rare disease, and established brand pharmaceutical products, royalties, and other pharmaceutical services. Revenue is recognized when obligations under the terms of contracts with customers are satisfied, which generally occurs when control of the products sold is transferred to the customer. Generally, the Company does not incur incremental costs to obtain contracts that would otherwise not have been incurred. The Company has not identified any agreements or arrangement that would qualify as a significant financing component. Sales of 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. 73 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Revenue from Distribution Agreements From time to time, the Company may enter into marketing and distribution agreements with third parties in which products are sold under Abbreviated New Drug Applications (“ANDAs”) or New Drug Applications (“NDAs”) owned or licensed by third parties. These products are sold under the ANI label. The Company controls the products sold under these marketing and distribution agreements and therefore are the principal for sales under each of these marketing and distribution agreements. As a result, revenue is recognized on a gross basis when control has passed to the customer and the performance obligation has been satisfied. Under these agreements, the Company pays third parties a specified percentage of the gross profit earned on sales of the products. These profit-sharing percentages are recognized in cost of sales in the consolidated statements of operations and are accrued in accrued royalties in the consolidated balance sheets until payment has occurred. Contract Manufacturing Product Sales Revenue Contract manufacturing arrangements consist of agreements in which pharmaceutical products are manufactured by the Company on behalf of a third party. The performance obligation is to manufacture and provide pharmaceutical products to customers, typically pharmaceutical companies. The products are sold at predetermined standalone selling prices and the performance obligation is considered to be satisfied when control of the product is transferred to the customer. Control is transferred to the customer when the product leaves the shipping dock to be shipped to the customer, as 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. Typically, there are no material returns for contract manufactured products. Royalties from Licensing Agreements From time to time, the Company enters into licensing agreements, under which the Company licenses to the seller the right to sell the acquired products. Because these royalties are sales-based, the Company recognizes the revenue when the underlying sales occur, based on sales and gross profit information received from the sellers. The Company may enter into agreements which include profit-sharing percentages on gross profits. The profit-sharing percentages are recorded in cost of sales in the consolidated statements of operations when the associated revenue is recognized and are recorded in accrued royalties in the consolidated balance sheets when the associated revenue is recognized and until payment has occurred. Cash, Cash Equivalents, and Restricted Cash All highly liquid investments with original maturities of three months or less from the date of purchase are classified as cash equivalents. Cash and cash equivalents consist of cash deposited in checking accounts, time deposits with maturities of less than three months, and money market accounts with maturities of three months or less at the date of purchase. Cash and cash equivalents include cash on-hand and money market funds which invest exclusively in high-quality, short-term securities that are issued or guaranteed by the U.S. government. Due to the short-term maturity of the funds invested in the money market accounts, the carrying amounts are a reasonable estimate of fair value. All interest bearing and non-interest bearing accounts are guaranteed by the Federal Deposit Insurance Corporation (“FDIC”) up to $ 250 thousand. The majority of the Company's cash balances are in excess of FDIC coverage, which the Company considers to be a normal business risk. Restricted cash at December 31, 2022, represented $ 5.0 million of funds held in a bank account owned by the Company to be used to pay for future milestones related to the purchase of the rights, title, and interest in the NDA for Inderal LA, as well as certain documentation, trademark rights, and finished goods from Cranford Pharmaceuticals, LLC in April 2016. This amount was was released from restricted cash during the first quarter of the year ended December 31, 2023. 74 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Accounts Receivable The Company extends credit to customers on an unsecured basis. Expected credit losses are measured at amortized cost, including trade and unbilled receivables, on a collective basis, based on their similar risk characteristics. Expected credits losses are based on historical credit loss experience, review of the current aging or status of accounts receivable and current and forward-looking views from an economic and industry perspective. Receivables are written off when it is determined that amounts are uncollectible. The allowance for credit losses was immaterial as of December 31, 2023 and 2022. Inventories Inventories consist of raw materials, packaging materials, work-in-progress, and finished goods. Inventories are stated at the lower of standard cost or net realizable value. The Company periodically reviews and adjusts standard costs, which generally approximate weighted average cost. Property and Equipment Property and equipment are recorded at cost. Expenditures for repairs and maintenance are charged to expense as incurred. Depreciation is recorded on a straight-line basis over estimated useful lives as follows: Classification Years Buildings and improvements 20 - 40 years Leasehold improvements Shorter of asset's useful life or remaining life of lease Machinery, furniture, and equipment 3 - 10 years Construction in progress consists of multiple projects, primarily related to new equipment and expansion of laboratory and manufacturing facilities to expand manufacturing capability as product lines grow. Construction in progress includes the cost of construction and other direct costs attributable to the construction, along with capitalized interest. Depreciation is not recorded on construction in progress until such time as the assets are placed in service. The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. No impairment loss related to property and equipment was recognized during the years ended December 31, 2023, 2022, and 2021. Assets Held-for-Sale The Company classifies assets held-for-sale if all held-for-sale criteria is met pursuant to ASC 360-10, Property, Plant and Equipment . Criteria include management commitment to sell the disposal group in its present condition and the sale being deemed probable of being completed within one year. Assets classified as held-for-sale are not depreciated and are measured at the lower of their carrying amount or fair value less cost to sell. The Company assesses the fair value of a disposal group, less any costs to sell, each reporting period it remains classified as held-for-sale and reports any subsequent changes as an adjustment to the carrying value of the disposal group, as long as the new carrying value does not exceed the initial carrying value of the disposal group. The Company determined that the Oakville, Ontario, Canada property met the held-for-sale criteria. As of December 31, 2023 and 2022, approximately $ 8.0 million of assets held for sale were recorded on the consolidated balance sheets. See Note 4 to the consolidated financial statements for additional information. 75 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Leases Operating lease right-of-use ("ROU") assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term. Leases with an initial term of twelve months or less are not recorded on the consolidated balance sheet, and the Company does not separate lease and non-lease components of contracts. There are no material residual guarantees associated with any of the Company’s leases, and there are no significant restrictions or covenants included in the Company’s lease agreements. Operating lease ROU assets are included in other non-current assets and operating lease liabilities are included in accrued expenses and other and other non-current liabilities in the consolidated balance sheets. As of December 31, 2023 and 2022, the Company did not have any finance leases. Intangible Assets Intangible assets with definite lives are amortized based on their pattern of economic benefit over their estimated useful lives and reviewed periodically for impairment. The definite-lived ANDAs, 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 ten years , based on the straight-line amortization method. In the case of certain NDA and product rights, an accelerated amortization method is used to better match the anticipated economic benefits expected to be provided. Management reviews definite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable, in a manner similar to that for property and equipment. During the year ended December 31, 2023, no impairment charges were recognized on intangible assets.. During the year ended December 31, 2022, the Company recognized a full impairment of a definite-lived ANDA asset with a remaining carrying value of $ 0.1 million. During the year ended December 31, 2021, the Company recognized an impairment charge of $ 2.4 million related to a definite-lived ANDA intangible asset. No events or circumstances arose in 2023, 2022, or 2021 that indicated that the carrying value of any of the other definite-lived intangible assets may not be recoverable. 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. Indefinite-lived intangibles are tested for impairment at least annually, as of October 31, and whenever events or changes in circumstances indicate that the carrying amount of the asset might not be recoverable. Judgment is used in determining when these events and circumstances arise. No events or circumstances arose in 2023 that indicated that the carrying value of any of the indefinite-lived intangible assets may not be recoverable. Goodwill Goodwill, which represents the excess of purchase price over the fair value of net assets acquired, is carried at cost, using the purchase method of accounting, and is related to past business combinations with BioSante Pharmaceuticals, Inc., WellSpring, and Novitium. Goodwill is not amortized, but is subject to periodic review for impairment. The Company is organized in two operating segments, and two reporting units, and has determined that goodwill resides in one reporting unit, Generics, Established Brands, and Other. 76 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 The Company reviews goodwill for impairment on a reporting unit basis annually, on October 31, and whenever events or changes in circumstances indicate the carrying value of goodwill might not be recoverable. Under the authoritative guidance issued by the FASB, the Company has the option to first assess the qualitative factors to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform a quantitative goodwill impairment test. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than its carrying amount, then the goodwill impairment test is performed. The goodwill impairment test requires the Company to estimate the fair value of the reporting unit and to compare the fair value of the reporting unit with its carrying amount. If the fair value exceeds the carrying amount, then no impairment is recognized. If the carrying amount recorded exceeds the fair value calculated, then an impairment charge is recognized for the difference. The judgments made in determining the projected cash flows used to estimate the fair value can materially impact the Company’s financial condition and results of operations. The Company assessed the assets qualitatively, and concluded it was more likely than not that the fair value of the Generics, Established Brands, and Other reporting unit is greater than its carrying value as of October 31, 2023 and 2022, and therefore no quantitative testing for impairment was required. No impairment loss related to goodwill was recognized in the years ended December 31, 2023, 2022, and 2021. Collaborative Arrangements The Company may enter into collaborative arrangements with various commercial partners to further business opportunities. In collaborative arrangements revenues and costs generated by collaborative arrangements may be presented on a gross or net basis depending on the specific facts of the collaborative arrangement. Research and Development Expenses Research and development ("R&D") activities are expensed as incurred. R&D expenses primarily consist of direct and allocated expenses incurred with the process of formulation, clinical research, and validation associated with new product development. Stock-Based Compensation The Company issues stock options and restricted stock awards, which are awarded in exchange for employee and non-employee director services. From time to time, the Company may grant awards through an inducement grant outside of the incentive plan to induce prospective employees to accept employment with the Company. These grants are made pursuant to inducement grants outside of the shareholder approved equity plan as permitted under the Nasdaq Stock Market listing rules. Stock-based compensation cost for stock options is determined at the grant date using an option pricing model and stock-based compensation cost for restricted stock awards is based on the closing market price of the stock at the grant date. The value of the award is recognized as expense on a straight-line basis over the employee’s requisite service period and classified where the underlying salaries are classified. Forfeitures are accounted for as they occur. Excess tax benefits or tax deficiencies are recognized as a component of the current period provision for income taxes. Awards may also be issued in the form of Performance Stock Units (“PSUs”) to certain employees of the Company. PSUs represent the right to receive a number of shares of Company common stock, contingent upon the achievement of specified performance objectives during a specified performance period. PSUs granted vest over a three-year performance period. Currently, the PSU’s vesting is contingent upon the Company meeting certain total shareholder return (“TSR”) levels as compared to a select peer group over the over three years , and contingent upon the Company meeting certain adjusted non-GAAP year-on-year earnings before interest, income taxes, depreciation, and amortization (“EBITDA”) growth rates over the vesting term. The related share-based compensation expense is determined based on the estimated fair value of the underlying shares on the date of grant and is recognized straight-line over the vesting term. 77 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 The Company also administers an Employee Stock Purchase Plan (“ESPP”). The estimated fair value of stock-based compensation awards are recognized and classified in the expense where the underlying salaries are classified. Valuation of stock awards requires us to make assumptions and to apply judgment to determine the fair value of the awards. These assumptions and judgments include estimating the future volatility of the Company's stock price and dividend yields. Changes in these assumptions can affect the fair value estimate. Income Taxes The Company uses 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. The Company is subject to taxation in various U.S. jurisdictions, Canada, and India, and all of our income tax returns remain subject to examination by tax authorities due to the availability of net operating loss carryforwards. 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. The Company has previously entered into an interest rate swap agreement (Note 6) designated as a cash flow hedge designed to manage exposure to changes in SOFR-interest rate underlying our variable rate debt. Due to the effective nature of the hedge, the initial fair value of the hedge and subsequent changes in the fair value of the hedge are recognized in other comprehensive income (loss) in the consolidated balance sheets. Income taxes are allocated to the hedge component of other comprehensive income (loss) based on appropriate intra-period tax allocations when those effects are deemed material. Derivative Instruments and Hedge Accounting The Company uses interest rate swaps to hedge exposure to interest rate risk, as well as benefit from favorable conditions. The Company recognizes all derivative instruments as either assets or liabilities at fair value. For all of the Company’s derivative positions that are designated and qualify as part of a cash flow hedging relationship, the effective portion of the gain or loss on the derivatives is reported as a component of other comprehensive income (loss) and reclassified into earnings in the same period or periods during which the hedged transactions affect earnings. Gains and losses on derivatives representing any ineffective component of the hedge are recognized in current earnings. All of the Company’s cash flow hedges have been deemed effective as of December 31, 2023 for both accounting and tax purposes. The Company has elected hedge accounting for both U.S. GAAP and tax purposes. The Company maintains formal documentation through a periodic memo and accounting analysis that cover what is being hedged, how it is being hedged, hedge effectiveness, the nature of the risk being hedged, among other required analyses. Company policy further includes a quarterly probability analysis covering hedge effectiveness. 78 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Contingent Consideration The terms of the acquisition agreement between ANI and Novitium Pharma LLC include the potential payment of future consideration that is contingent upon the achievement of certain regulatory and financial performance milestones. At the acquisition date, contingent consideration is recorded at fair value based on the additional consideration expected to be transferred, which is based on the estimate of probability-weighted future cash flows as discounted to present value. Significant inputs used in the measurement of the fair value include discount rates, probabilities of achievement of regulatory-based milestones and payments, and projected revenues and gross profits. The discount rates are derived using accepted valuation methodologies. The probability of achievement of regulatory milestones is based on historical and projected success rates. The projected revenues and gross profits are based on internal forecasts and long-term plans. The contingent consideration is remeasured each reporting period using Level 3 inputs. Changes in fair value, which incorporate changes in assumptions and the passage of time, are recognized as an operating expense in the consolidated statements of operations. As payments are not expected to be made shortly after the acquisition, any future payment of contingent consideration will be reported as a financing cash flow for amounts paid up to the acquisition-date fair value of the consideration, and as an operating cash outflow for any amounts in excess of the acquisition-date fair value in our consolidated statement of cash flows. Fair Value Measurements Fair value is defined as 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 which prioritizes and ranks the level of observability of inputs used in measuring fair value. These tiers include: • Level 1—Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. • Level 2—Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities. • Level 3—Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. The consolidated balance sheets include certain financial instruments (primarily cash and cash equivalents, prepaid expenses, accounts receivable, accounts payable, accrued expenses, and other current liabilities) that are carried at cost and that approximate fair values as of December 31, 2023, 2022 due to their short term nature. See Note 10 for additional information regarding fair value. Recent Accounting Pronouncements Recent Accounting Pronouncements Not Yet Adopted From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. In November 2023, the FASB issued Accounting Standards Update ("ASU") 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which improves reportable segment disclosure requirements, primarily through enhanced disclosures related to significant segment expenses. The guidance in this ASU is effective for all public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The guidance is applied retrospectively to all periods presented in the financial statements, unless it is impracticable. The Company is currently evaluating the effect the adoption of this ASU may have on its disclosures in the notes to the consolidated financial statements. 79 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which includes guidance to expand the disclosure requirements for income taxes, specifically related to the rate reconciliation and income taxes paid. These amendments are effective for all public entities for fiscal periods beginning after December 15, 2024, with early adoption permitted. These amendments apply on a prospective basis, but entities have an option to apply it retrospectively for all periods presented. The Company does not expect that the adoption of this guidance will have a material impact on the consolidated financial statements. Recent Accounting Pronouncements Adopted In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting . This ASU provides optional expedients and exceptions, that may be elected over time as reference rate reform activities occur, for applying GAAP to contracts, hedging relationships and other transactions that reference the London Interbank Offered Rate ("LIBOR") or another reference rate expected to be discontinued because of reference rate reform. The guidance in this ASU was extended in December 2022 when the FASB issued ASU 2022-06, Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848 , extending the sunset date under Topic 848 to December 31, 2024 to align the temporary accounting relief guidance with the expected LIBOR cessation. In August 2023, the Company completed the transition of its debt and derivative instruments from LIBOR to Adjusted Term Secured Overnight Financing Rate ("SOFR") and applied the optional expedients in ASC 848 related to contract modifications and changing critical terms of the Company’s hedging relationships. Application of these expedients allowed the Company to preserve presentation of derivatives as qualifying cash flow hedges and to account for the debt modification as a continuation of the existing contract. The adoption of this guidance did not have a material impact on the consolidated financial statements. 2. REVENUE RECOGNITION AND RELATED ALLOWANCES Revenue Recognition Revenues are primarily derived from sales of generic, rare disease, and established brand pharmaceutical products, royalties, and other pharmaceutical services. Revenue is recognized when obligations under the terms of contracts with customers are satisfied, which generally occurs when control of the products we sell is transferred to the customer. Variable consideration is estimated after the consideration of applicable information that is reasonably available. The Company generally does not have incremental costs to obtain contracts that would otherwise not have been incurred. The Company does 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 consolidated statements of operations is considered to be revenue from contracts with customers. The following table depicts the disaggregation of revenue: Products and Services Years Ended December 31, (in thousands) 2023 2022 2021 Sales of generic pharmaceutical products $ 269,449 $ 210,121 $ 143,571 Sales of established brand pharmaceutical products, royalties, and other pharmaceutical services 105,250 64,578 72,565 Sales of rare disease pharmaceutical products 112,117 41,686 — Total net revenues $ 486,816 $ 316,385 $ 216,136 80 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Timing of Revenue Recognition Years Ended December 31, (in thousands) 2023 2022 2021 Performance obligations transferred at a point in time $ 486,441 $ 313,436 $ 214,826 Performance obligations transferred over time 375 2,949 1,310 Total $ 486,816 $ 316,385 $ 216,136 In the years ended December 31, 2023 or 2022, the Company did not incur, and therefore did not defer, any material incremental costs to obtain or fulfill contracts. As of December 31, 2023, there were no contract assets recorded which were related to revenue recognized based on percentage of completion but not yet billed. The Company recognized an increase of $ 4.1 million of net revenue from performance obligations satisfied in prior periods during the year ended December 31, 2023, consisting primarily of revised estimates for variable consideration, including chargebacks, rebates, returns, and other allowances, related to prior period sales. For the years ended December 31, 2023 and 2022, the Company recognized less than $ 0.1 million of revenue that was included in deferred revenue as of December 31, 2022 and 2021. As of December 31, 2023, the aggregate amount of the transaction price allocated to the remaining performance obligations for all open contract manufacturing customer contracts was $ 6.3 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 . Variable Consideration Sales of 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. Chargebacks Chargebacks, primarily from wholesalers, result from arrangements with indirect customers establishing prices for products which the indirect customer purchases through a wholesaler. Alternatively, the Company may pre-authorize wholesalers to offer specified contract pricing to other indirect customers. Under either arrangement, the Company provides a chargeback credit to the wholesaler for any difference between the contracted price with the indirect customer and the wholesaler’s invoice price, typically Wholesale Acquisition Cost (“WAC”). Prior period chargebacks claimed by wholesalers are analyzed to determine the actual average selling price (“ASP”) for each product. This calculation is performed by product by wholesaler. ASPs can be affected by several factors such as: • A change in customer mix • A change in negotiated terms with customers • A change in the volume of off-contract purchases • Changes in WAC As necessary, ASPs are adjusted based on anticipated changes in the factors above. The difference between ASP and WAC is recorded as a reduction in both gross revenues in the consolidated statements of operations and accounts receivable in the consolidated balance sheets, at the time revenue is recognized from the product sale. The Company continually monitors chargeback activity and adjusts ASPs when the Company believes that actual selling prices will differ from current ASPs. 81 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Government Rebates Government rebates reserve consists of estimated payments due to governmental agencies for utilization of our products by beneficiaries under such governmental programs. The two largest government programs are Medicaid and Medicare. The Company participates in the Medicaid Drug Rebate Program and pays rebates to the states related on Medicaid beneficiary utilization of the Company's products. Medicaid rebates are billed 60-90 days of the end of the quarter in which the product was dispensed to a Medicaid beneficiary. Medicaid rebate amounts per product unit are established by law, based on the Average Manufacturer Price (“AMP”), which is reported on a monthly and quarterly basis, and, in the case of branded products, best price, which is reported on a quarterly basis. Medicaid reserves are based on expected claims from state Medicaid programs. Estimates for expected claims are driven by patient usage, sales mix, calculated AMP or best price, as well as inventory in the distribution channel that will be subject to a Medicaid rebate. As a result of the delay between selling the products, dispensing the products and rebate billing, the Medicaid rebate reserve includes both an estimate of outstanding claims for end-customer sales that have occurred but for which the related claim has not been billed, as well as an estimate for future claims that will be made when inventory in the distribution channel is sold through to plan participants. Many of the products are also covered under Medicare. ANI participates in the Coverage Gap Discount Program in order for its branded drugs to be covered by Medicare Part D and must provide a rebate for any products sold under NDAs dispensed to Medicare Part D beneficiaries while the beneficiaries are in the Coverage Gap phase of the benefit. This applies to all products sold under NDAs, regardless of whether the products are marketed as branded or generic. Estimates for these discounts are based on historical experience with Medicare rebates for products. Medicare rebates are billed quarterly for drugs dispensed to Medicare beneficiaries in the prior quarter, which is typically 120 days after the product is shipped. As a result of the delay between selling the products, dispensing the products and rebate billing, Medicare rebate reserve includes both an estimate of outstanding claims for end-customer sales that have occurred but for which the related claim has not been billed, as well as an estimate for future claims that will be made when inventory in the distribution channel is sold through to Medicare Part D participants. To evaluate the adequacy of the government rebate reserves, reserves are reviewed on a quarterly basis against actual claims data to ensure the liability is fairly stated. The Company continually monitors the government rebate reserve and adjusts estimates if it is expected that actual government rebates may differ from established accruals. Accruals for government rebates are recorded as a reduction to gross revenues in the consolidated statements of operations and as an increase to accrued government rebates in the consolidated balance sheets. Returns A returns policy is in place that allows customers to return product within a specified period prior to and subsequent to the expiration date. Generally, product may be returned for a period beginning six months prior to its expiration date to up to one year after its expiration date. Product returns are settled through the issuance of a credit to the customer. The estimate for returns is based upon historical experience with actual returns. While such experience has allowed for reasonable estimation in the past, history may not always be an accurate indicator of future returns. We continually monitor estimates for returns and make adjustments when it is expected that actual product returns may differ from the established accruals. Accruals for returns are recorded as a reduction to gross revenues in the consolidated statements of operations and as an increase to the return goods reserve in the consolidated balance sheets. 82 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Administrative Fees and Other Rebates Administrative fees or rebates are offered to wholesalers, group purchasing organizations, and indirect customers. Fees and rebates are accrued, by product by wholesaler, at the time of sale based on contracted rates and ASPs. To evaluate the adequacy of the administrative fee accruals, on-hand inventory counts are obtained from the wholesalers. The Company continually monitors administrative fee activity and adjust accruals when it is expected that actual administrative fees may differ from the accruals. Accruals for administrative fees and other rebates are recorded as a reduction in both gross revenues in the consolidated statements of operations and accounts receivable in the consolidated balance sheets. Prompt Payment Discounts Sales discounts may be granted to customers for prompt payment. The reserve for prompt payment discounts is based on invoices outstanding. Based on past experience, it is assumed that all available discounts will be taken. Accruals for prompt payment discounts are recorded as a reduction in both gross revenues in the consolidated statements of operations and accounts receivable in the consolidated balance sheets. The following table summarizes activity in the consolidated balance sheets for accruals and allowances for the years ended December 31, 2023, 2022, and 2021: Accruals for Chargebacks, Returns, and Other Allowances (in thousands) Chargebacks Government Rebates Returns Administrative Fees and Other Rebates Prompt Payment Discounts Balance at December 31, 2021 (1) $ 94,066 $ 5,492 $ 35,831 $ 13,100 $ 4,642 Accruals/Adjustments 642,409 20,657 23,252 42,044 21,302 Credits Taken Against Reserve ( 587,913 ) ( 15,277 ) ( 25,684 ) ( 45,702 ) ( 19,456 ) Balance at December 31, 2022 (1) $ 148,562 $ 10,872 $ 33,399 $ 9,442 $ 6,488 Accruals/Adjustments 586,511 23,915 18,360 55,798 22,932 Credits Taken Against Reserve ( 650,865 ) ( 22,619 ) ( 22,081 ) ( 53,828 ) ( 24,555 ) Balance at December 31, 2023 (1) $ 84,208 $ 12,168 $ 29,678 $ 11,412 $ 4,865 ____________________ (1) Chargebacks are included as an offset to accounts receivable, net of chargebacks and other allowances in the consolidated balance sheets. Administrative Fees and Other Rebates and Prompt Payment Discounts are included as a reduction to accounts receivable, net of chargebacks and other allowances or accrued expenses and other in the consolidated balance sheets. Returns are included in returned goods reserve in the consolidated balance sheets. Government Rebates are included in accrued government rebates in the consolidated balance sheets. Credit Concentration Customers are primarily wholesale distributors, chain drug stores, group purchasing organizations, and other pharmaceutical companies. During the year ended December 31, 2023 four customers accounted for 10% or more of net revenues. During the years ended December 31, 2022 and 2021 , three customers accounted for 10% or more of net revenues. As of December 31, 2023, accounts receivable from these customers totaled 81 % of accounts receivable, net. 83 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 The four customers represent the total percentage of net revenues as follows: Years Ended December 31, 2023 2022 2021 Customer 1 31 % 26 % 29 % Customer 2 13 % 18 % 23 % Customer 3 13 % 15 % 16 % Customer 4 12 % 6 % — % 3. BUSINESS COMBINATION On November 19, 2021, the Company acquired all of the interests of Novitium pursuant to the terms of the Agreement and Plan of Merger, dated as of March 8, 2021. This acquisition was accounted for as a business combination. The total consideration consisted of cash of approximately $ 88.1 million, 2,466,654 restricted shares of common stock valued at $ 91.2 million, and up to $ 46.5 million in additional contingent consideration. Additionally, the Company agreed to pay certain debts of Novitium in the amount of $ 8.5 million. 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 acquisition date, the contingent consideration had a fair value of $ 30.8 million. Total consideration including cash, restricted shares and contingent consideration, net of cash acquired of $ 12.1 million was $ 206.5 million at the date of purchase. The fair value of the contingent consideration was $ 24.0 million and $ 35.1 million as of December 31, 2023 and 2022, respectively. Refer to Note 10 for changes in contingent consideration and changes in fair value. The cash consideration was funded in part by borrowings under the cr edit facility (Note 5) and through issuance of convertible preferred stock sha res. Concurrently with the execution of the Merger Agreement, the Company entered into an Equity Commitment and Investment Agreement with Ampersand 2020 Limited Partnership (the “PIPE Investor”), pursuant to which the PIPE Investor agreed to purchase, 25,000 shares of the Company's 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 on November 19, 2021 (Note 11) . T he acquisition of Novitium was completed due to its proven track record of being a research and development growth engine capable of fueling sustainable growth, to expand the research and development pipeline via niche opportunities, to enhance the contract development and manufacturing organization (“CDMO”) business and U.S. based manufacturing capacity, and to diversify the Company's revenue base. 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, $ 46.9 million of indefinite-lived in-process research and development intangible assets, $ 67.4 million of acquired ANDA intangible assets, $ 24.9 million of customer relationship intangible assets, and goodwill of $ 24.6 million was recognized. 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 $ 149.9 million and $ 90.3 million of revenue during the years ended December 31, 2023 and 2022, respectively. Transaction Costs In conjunction with the acquisition, approximately $ 9.4 million in transaction costs were expensed during the year ended 2022 as selling, general, and administrative expense in the consolidated statement of operations. 84 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Restricted Shares The Novitium acquisition consideration included 2,466,654 restricted shares, which were valued at $ 91.2 million. These shares contained restrictions on their transfer for periods from three to twenty-four 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 % to 71 %, and the discounted lack of marketability with a range of 7.5 % to 21.5 % depending on the length of restriction. Pro Forma Consolidated Financial Information (unaudited) The following unaudited pro forma consolidated financial information summarizes the results of operations for the periods indicated as if the Novitium acquisition had been completed as of January 1, 2020. Year Ended December 31, (in thousands) 2021 Net revenues $ 272,888 Net loss $ ( 31,740 ) 4. RESTRUCTURING On March 31, 2023 the Compan y ceased operations at the Oakville, Ontario, Canada manufacturing plant. This action was part of ongoing initiatives to capture operational synergies following the acquisition of Novitium in November 2021. ANI has fully completed the transition of the products manufactured or packaged in Oakville to one of the Company's three U.S.-based manufacturing sites. For the year ended December 31, 2023, restructuring activities resulted in expenses of $ 1.1 million. This included $ 0.2 million of severance and other employee benefit costs and $ 0.7 million of asset-related impairment and accelerated depreciation costs, and $ 0.2 million for other miscellaneous other costs. As of December 31, 2023, $ 0.1 million of the severance and other employee benefits are unpaid and accrued. For the year ended December 31, 2022, restructuring activities resulted in expenses of $ 5.7 million. This included $ 2.1 million of severance and other employee benefit costs and $ 3.1 million of asset-related impairment and accelerated depreciation costs, and $ 0.4 million for other miscellaneous other costs. There were no restructuring expenses incurred for the year ended December 31, 2021. These costs are recorded as restructuring activities, an operating item, in the accompanying consolidated statements of operations. Certain of the severance and other employee benefit costs contain a service requirement, and as such, are being accrued over time as they are earned. In conjunction with the exit of the Canadian facility, the Company has determined that the land and building at the Oakville, Ontario, Canada plant will be sold together and met the criteria to be classified as held for sale as of March 31, 2023. The land and building have a net carrying value of $ 8.0 million, which is presented as assets held for sale on the accompanying consolidated balance sheets as of December 31, 2023. These assets are part of the Generics, Established Brands, and Other segment. On November 6, 2023, ANI Pharmaceuticals Canada Inc., a wholly owned subsidiary of the Company, entered into an agreement with a potential buyer for the sale of the Oakville, Ontario manufacturing facility, however, the agreement was subsequently terminated in December 2023 by mutual agreement. In February 2024, the Company entered into an agreement for the purchase and sale of the Oakville site, for a purchase price of 19.2 million Canadian Dollars, or approximately $ 14.2 million US Dollars, based on the current exchange rate. The sale is expected to close in March 2024 (Note 19). 85 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 5. 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, repay the existing credit facility, and pay fees, costs and expenses incurred in connection with the merger. The Term Facility matures in November 2027 and the Revolving Facility in November 2026. The Credit Facility has a subjective acceleration clause in case of a material adverse effect. In July 2023, the Company amended its Credit Agreement to transition from LIBOR to SOFR due to the cessation of LIBOR pursuant to the terms of Amendment No.1 to the Credit Agreement (“Amendment No. 1”). SOFR will be applied to the Credit Facility for the interest period (as defined in the Credit Agreement) beginning on August 1, 2023 and replaced all LIBOR terms. The Credit Facility 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 SOFR Rate (or alternate benchmark rate as defined in the Credit Agreement) in the case of SOFR 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 SOFR Rate (as defined in the Credit Facility) in the case of loans under the Revolving Facility. Amendment No. 1 also includes the addition of a credit spread adjustment of 0.11448 % for an interest period of one-month duration, 0.26161 % for a three-month duration, and 0.42826 % for a six-month duration, in addition to SOFR and the applicable margin, as noted above. There were no other changes or modifications to the Credit Agreement. The Company has applied the optional expedients in ASC 848, Reference Rate Reform , and elected to treat the change in the benchmark interest rate to SOFR as a continuation of the existing Credit Agreement and account for the change prospectively. The interest rate under the Term Facility was 11.46 % at December 31, 2023. As of December 31, 2023, there was $ 0 drawn on the Revolving Facility and $ 40.0 million remained available for borrowing subject to certain conditions. The Company 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. A commitment fee of 0.5 % per annum on any unused portion of the Revolving Facility. 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 the years ended December 31: Current (in thousands) 2023 2022 Current borrowing on debt $ 3,000 $ 3,000 Deferred financing costs ( 2,150 ) ( 2,150 ) Current debt, net of deferred financing costs $ 850 $ 850 86 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Non-Current (in thousands) 2023 2022 Non-current borrowing on debt $ 291,000 $ 294,000 Deferred financing costs ( 6,181 ) ( 8,331 ) Non-current debt, net of deferred financing costs and current component $ 284,819 $ 285,669 As of December 31, 2023, outstanding principal was $ 294.0 million on the Term Facility. Of the $ 0.6 million of unamortized deferred debt issuance costs allocated to the Revolving Facility, $ 0.4 million is included in other non-current assets in the consolidated balance sheets, and $ 0.2 million is included in prepaid expenses and other current assets in the consolidated balance sheets. The contractual maturity of the Term Facility is as follows for the years ending December 31: (in thousands) Term Facility 2024 $ 3,000 2025 3,000 2026 3,000 2027 285,000 Total $ 294,000 The following table sets forth the components of total interest expense related to the Term Facility recognized in the accompanying consolidated statements of operations for the years ended December 31: (in thousands) 2023 2022 2021 Contractual coupon $ 30,692 $ 26,150 $ 11,129 Amortization of finance fees 2,364 2,363 914 Capitalized interest ( 587 ) ( 95 ) ( 98 ) $ 32,469 $ 28,418 $ 11,945 6. DERIVATIVE FINANCIAL INSTRUMENT AND HEDGING ACTIVITY In April 2020, the Company entered into an interest rate swap with Citizens Bank, N.A. to manage exposure to changes in LIBOR-based interest rates (or alternate benchmark rate as defined in the Credit Agreement) underlying total borrowings under term facilities related to the 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 at origin on November 19, 2021 was novated and Truist Bank became the new counterparty. As described further below, the Company amended its Credit Agreement to transition from LIBOR to SOFR due to the cessation of LIBOR, and accordingly, the interest rate swap transitioned from LIBOR to SOFR. The swap is used to manage changes in SOFR-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. The notional amount of the interest rate swap was $ 139.4 million and $ 151.5 million as of December 31, 2023 and 2022, respectively, and decreased quarterly by approximately $ 4.0 million until December 2023, after which it remains static until maturity in December 2026. As of December 31, 2023, the fair value of the interest rate swap asset was recorded in other non-current assets in the consolidated balance sheets was $ 6.2 million. As of December 31, 2023, $ 8.9 million was recorded in accumulated other comprehensive income (loss) in the consolidated balance sheets. 87 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 During the year ended December 31, 2023, the change in fair value of the interest rate swaps was a loss of $ 3.7 million. During the year ended December 31, 2023, losses on the interest rate swap of $ 3.4 million were recorded in other comprehensive income (loss) , net of tax. Di fferences between the hedged SOFR 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 SOFR rate. In the years ended December 31, 2023 and 2022, $ 2.6 million and $ 2.3 million, respectively, of interest expense was recognized in relation to the interest rate swaps. Included in these amounts for the years ended December 31, 2023 and 2022 are reclassifications out of accumulated other comprehensive income (loss) of $ 2.8 million in expense, related to terminated and de-designated cash flow hedges. In conjunction with the amendment of the Credit Agreement (Note 5), the Company’s derivative positions automatically transitioned to SOFR, the designated fallback terms, as determined by the International Swaps and Derivatives Association on August 1, 2023. Concurrently, the Company updated its hedge documentation to reflect the change of the benchmark index, which changed solely as a result of reference rate reform. Under ASC 848, Reference Rate Reform, hedge accounting may continue without de-designation if certain criteria are met. For cash flow hedges in which the designated hedged risk is LIBOR (or another rate that is expected to be discontinued), the guidance allows an entity to assert that it remains probable that the hedged forecasted transaction will occur. The Company applied the optional expedient within ASC 848 to conclude the updates to the hedge relationship due to reference rate reform did not have a material impact on the Company's consolidated financial statements. 7. INVENTORIES The following table shows the Company's inventory by asset class as of the years ended December 31: (in thousands) 2023 2022 Raw materials $ 62,237 $ 67,726 Packaging materials 9,617 7,720 Work-in-progress 3,144 1,889 Finished goods 36,198 28,020 Inventories $ 111,196 $ 105,355 Vendor Concentration Raw materials are sourced for products, including API, from both domestic and international suppliers. Generally, only a single source of API is qualified for use in each product due to the costs and time required to validate a second source of supply. As a result, we are dependent upon current vendors to supply reliably the API required for on-going product manufacturing. During the year ended December 31, 2023, no single vendor represented at least 10% of invent ory purchases. During th e year ended December 31, 2022, the Company purchased approximately 19 % of inventory from one supplier. During the year ended December 31, 2021, no single vendor represented at least 10% of inventory purchases. 88 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 8. PROPERTY AND EQUIPMENT, NET The following tables show the Company’s gross property and equipment by major asset class and accumulated depreciation as of the years ended December 31: (in thousands) 2023 2022 Land $ 1,549 $ 1,549 Buildings 17,875 16,659 Machinery, furniture, and equipment 50,412 53,146 Construction in progress 7,692 4,604 77,528 75,958 Less: accumulated depreciation ( 32,935 ) ( 32,712 ) Property and equipment, net $ 44,593 $ 43,246 Depreciation expense for the years ended December 31, 2023, 2022, and 2021 totaled $ 7.5 million, $ 7.4 million, and $ 5.5 million, respectively. During the years ended December 31, 2023, 2022, and 2021 there was $ 0.6 million, $ 0.1 million, and $ 0.1 million, respectively, of interest capitalized into construction in progress, respectively. 9. GOODWILL AND INTANGIBLE ASSETS Goodwill As a result of the 2013 merger with BioSante Pharmaceuticals, Inc. (“BioSante”), the Company recorded goodwill of $ 1.8 million. As a result of the acquisition of WellSpring Pharma Services Inc., the Company recorded goodwill of $ 1.7 million in 2018. From the acquisition of Novitium in 2021, the Company recorded goodwill of $ 24.6 million. As of December 31, 2023, the Company had two operating segments, which were also deemed the Company's two reporting units, Generics, Established Brands, and Other reporting unit and the Rare Disease reporting unit. All of the goodwill is recorded in the Generics, Established Brands, and Other reporting unit.reporting unit. Goodwill is reviewed for impairment at least annually, at October 31st, or more frequently if a triggering event occurs between impairment testing dates. The Company’s impairment assessment begins with a qualitative assessment to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying value. Qualitative factors may include, macroeconomic conditions, industry and market considerations, cost factors, and other relevant entity and Company specific events. If, based on the qualitative test, the Company determines that it is “more likely than not” that the fair value of a reporting unit is less than its carrying value, then we evaluate goodwill for impairment by comparing the fair value of the reporting unit to its respective carrying value, including its goodwill. If it is determined that it is “not likely” that the fair value of the reporting unit is less than its carrying value, then no further testing is required. Based on the qualitative assessments performed by the Company, it was determined that it was more likely than not that the fair value of the Generics, Established Brands, and Other reporting unit was greater than its carrying value as of October 31, 2023, and therefore no impairment charges have been recognized, and no quantitative testing was required. In addition to the qualitative impairment analysis performed at October 31, 2023, there were no events or changes in circumstances that would have reduced the fair value of the reporting unit below its carrying value from October 31, 2023 to December 31, 2023. No impairment loss was recognized during the years ended December 31, 2023, 2022, and 2021, and the balance of goodwill was $ 28.2 million as of December 31, 2023 and 2022. 89 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 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: December 31, 2023 December 31, 2022 Weighted Average Amortization Period(1) (in thousands) Gross Carrying Amount Accumulated Amortization Net Carrying Amount Gross Carrying Amount Accumulated Amortization Net Carrying Amount Definite-Lived Intangible Assets: Acquired ANDA intangible assets $ 209,780 $ ( 100,660 ) $ 109,120 $ 195,862 $ ( 75,606 ) $ 120,256 5.2 years NDAs and product rights 244,871 ( 184,861 ) 60,010 242,372 ( 162,188 ) 80,184 3.1 years Marketing and distribution rights 17,157 ( 14,271 ) 2,886 17,157 ( 13,309 ) 3,848 3.0 years Non-compete agreement 624 ( 624 ) — 624 ( 602 ) 22 - years Customer relationships 24,900 ( 7,707 ) 17,193 24,900 ( 4,150 ) 20,750 4.8 years Total Definite-Lived Intangible Assets 497,332 ( 308,123 ) 189,209 480,915 ( 255,855 ) 225,060 4.5 years Indefinite-Lived Intangible Assets: In process research and development 19,800 — 19,800 26,575 — 26,575 Indefinite Total Intangible Assets, net $ 517,132 $ ( 308,123 ) $ 209,009 $ 507,490 $ ( 255,855 ) $ 251,635 (1) Weighted average amortization period as of December 31, 2023. Definite-lived intangible assets arising from business combinations and other asset acquisitions include intangibles such as Abbreviated New Drug Applications (“ANDAs”), New Drug Applications (“NDAs”) and product rights, marketing and distribution rights, customer relationships, and non-compete agreements. Definite-lived intangible assets are amortized over the estimated period during which the asset is expected to contribute directly or indirectly to future cash flows. Definite-lived intangible assets are stated at cost, net of amortization, and generally amortized over their remaining estimated useful lives, ranging from seven to ten years years, based on the straight-line amortization method. In the case of certain NDAs and product rights assets, an accelerated amortization method is used to better match the anticipated economic benefits expected to be provided. Definite-lived intangible assets are tested for impairment annually, or when events or changes in circumstances indicate that these asset might be impaired. Indefinite-lived intangible assets other than goodwill include primarily IPR&D projects. IPR&D intangible assets represent the fair value of technology acquired in a business combination or asset acquisition for which the technology projects are incomplete but have substance or alternative future use. When an IPR&D project is completed (generally upon receipt of regulatory approval), then the IPR&D will be accounted for as a definite-lived intangible asset. During 2023, definite-lived intangibles increased approximately $ 16.4 million, which includes $ 6.8 million which was reclassified from indefinite-lived IPR&D to acquired ANDA intangible assets upon completion of projects and launch of related products, and the Company added approximately $ 9.6 million of intangible assets, comprised of $ 7.1 million of ANDA intangible assets related to asset acquisitions with Slayback Pharma Limited Liability Company and Akorn Holding Company, $ 2.0 million in product rights related to the transaction with Alvogen, Inc., and other asset acquisitions. During 2022, approximately $ 20.3 million was reclassified from indefinite-lived IPR&D to acquired ANDA intangible assets upon completion of projects and launch of related products. The Company added $ 7.2 million in ANDA intangible assets related to the July 21, 2022 transaction with Oakrum Pharma, LLC (Note 10). These assets will be amortized over a seven -year useful life. 90 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Amortization expense for definite-lived intangible assets was $ 52.3 million, $ 49.5 million, and $ 41.8 million for the years ended December 31, 2023, 2022, and 2021, respectively. Refer to Note 10 for more details on acquired definite-lived and indefinite-lived intangible assets. Expected future amortization expense is as follows for the years ending December 31: (in thousands) 2024 $ 50,364 2025 47,128 2026 33,643 2027 24,677 2028 17,895 2029 and thereafter 15,502 Total $ 189,209 Expected amortization expense is an estimate. Actual amounts of amortization expense may differ due to timing of regulatory approvals related to IPR&D assets, additional intangible assets acquired, impairment of intangible assets, and other events. Indefinite-lived intangible assets are not amortized, and the Company tests for impairment of indefinite-lived intangible assets and definite-lived intangibles when events or circumstances indicate that the carrying value of the assets may not be recoverable, and the Company performs an asset impairment analysis annually, as of October 31, 2023. The Company performed qualitative assessments to determine whether it was more likely than not that the assets were impaired in order to determine the necessity of performing a quantitative impairment test, under which management would calculate the asset’s fair value. When performing the qualitative assessments, the Company evaluated events and circumstances that would affect the significant inputs used to determine the fair value of the assets. Based on the assessments of the aforementioned factors, it was determined that it was more likely than not that the fair value of assets are greater than their carrying amount as of October 31, 2023, and therefore no quantitative testing for impairment was required. In addition to the qualitative impairment analysis performed at October 31, 2023, there were no events or changes in circumstances that would have reduced the fair value of the indefinite or definite-lived intangible assets below their carrying values from October 31, 2023 to December 31, 2023. No impairment loss was recognized during the year ended December 31, 2023. During the years ended December 31, 2022 and 2021, impairment losses of approximately $ 0.1 million and $ 2.4 million, respectively, were recognized in relation to ANDA assets. 10. FAIR VALUE 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 which 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 the funds. The Term Facility bears an interest rate that fluctuates with the changes in SOFR and, because the variable interest rates approximate market borrowing rates available to the Company, the carrying values of these borrowings approximated their fair values at December 31, 2023 and 2022. 91 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis Money Market Funds Money market funds are readily convertible into cash and the net asset value of each fund on the last day of the reporting period is used to determine its fair value. Money market funds are included in Cash and cash equivalents within the Consolidated Balance Sheet, and is classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices. The Company does not adjust the quoted market price for such financial instruments. The fair value of the money market funds as of December 31, 2023 was approximately $ 191.8 million. Interest Rate Swap The fair value of the interest rate swap is estimated based on the present value of projected future cash flows using the SOFR 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 $ 6.2 million and $ 8.8 million at December 31, 2023 and 2022, respectively, and was classified as a non-current asset. Contingent Consideration In connection with the acquisition of Novitium, the Company 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. As of the November 19, 2021 acquisition date, the contingent consideration had a fair value of $ 30.8 million. Pursuant to the terms of the Agreement and Plan of Merger, dated as of March 8, 2021, on December 12, 2023, the Company paid $ 12.5 million of cash consideration to the Company Members, defined as the holders of Novitium ownership interests in the Agreement and Plan of Merger, as the holders of Novitium ownership interests, for the achievement of the "ANDA Filing Earn-Out," as defined in the Agreement (Note 17). Furthermore, on February 22, 2024, the Company paid $ 12.5 million to Company Members of Novitium upon the achievement of the "Gross Profit Earn-Out," as defined in the Agreement (Note 19). The fair value of the contingent consideration was approximately $ 24.0 million and $ 35.1 million as of December 31, 2023 and 2022, respectively, and is reflected as a current and non-current accrued contingent consideration liability in the consolidated balance sheets. 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 Assumptions Profit-based milestone payments Probability-weighted discounted cash flow Discount rate 12 % Projected fiscal year of payment 2025-2035 Product development-based milestone payments Probability-weighted discounted cash flow Discount rate 12.0 % Probability of payment 100 % Projected fiscal year of payment 2024 92 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 The following table presents the changes in contingent consideration balances classified as Level 3 balances for the years ended December 31, 2023 and 2022: Years Ended December 31, (in thousands) 2023 2022 Beginning balance $ 35,058 $ 31,000 Measurement period adjustment — 300 Payment of ANDA filing earn-out ( 12,500 ) — Change in fair value 1,426 3,758 Ending balance $ 23,984 $ 35,058 Contingent Value Rights The contingent value rights (“CVRs”), which were granted coincident with the merger with BioSante expired during June 2023, were considered contingent consideration and were classified as liabilities, and there were no payments made pursuant to the terms of the CVR agreement. The Company determined that the fair value of the CVRs was immaterial as of December 31, 2022, and also determined that the changes in such fair value were immaterial for the years ended December 31, 2022, and 2021. The following table presents financial assets and liabilities accounted for at fair value on a recurring basis as of December 31, 2023 and December 31, 2022, by level within the fair value hierarchy: (in thousands) Description Fair Value at December 31, 2023 Level 1 Level 2 Level 3 Assets Money Market Fund $ 191,841 $ 191,841 $ — $ — Interest rate swap $ 6,236 $ — $ 6,236 $ — Liabilities Contingent consideration $ 23,984 $ — $ — $ 23,984 Description Fair Value at December 31, 2022 Level 1 Level 2 Level 3 Assets Interest rate swaps $ 8,759 $ — $ 8,759 $ — Liabilities Contingent consideration $ 35,058 $ — $ — $ 35,058 Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis There are no 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 There are no non-financial assets and liabilities that are measured at fair value on a recurring basis. 93 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis Long-lived assets, including property and equipment, ROU assets, intangible assets, and goodwill, are measured at fair value on a non-recurring basis. During the year ended December 31, 2023, there were no impairment charges recognized related to non-financial assets and liabilities measured at fair value on a non-recurring basis. During the year ended December 31, 2022, the Company recognized an impairment charge of $ 0.1 million related to a definite-lived ANDA intangible asset. There were no other fair value impairments recognized in the years ended December 31, 2023 and 2022. Acquired Non-Financial Assets Measured at Fair Value On December 27, 2023, the Company acquired from Alvogen, Inc. the rights to certain pharmaceutical products for total cash consideration of $ 2.0 million (Note 8), which we plan to launch commercially in early 2024. The transaction was accounted for as an asset acquisition and there were no transaction costs directly related to the acquisition. Intangible assets amounted to $ 2.0 million as NDAs and product rights. The payment was allocated to the acquired intangible assets based on relative fair value, which was determined using Level 3 unobservable inputs. The intangible asset will be amortized in full over its useful life of seven years and will be tested for impairment when events or circumstances indicate that the carrying value of the asset may not be recoverable. No such triggering events were identified during the period from the date of acquisition to December 31, 2023. August 14, 2023, the Company acquired one ANDA and registered patents and pending patent applications from Slayback Pharma Limited Liability Company for total consideration of $ 3.0 million (Note 9). The Company also acquired an NDA which has yet to be filed. The transaction was funded from cash on hand. The transaction was accounted for as an asset acquisition and the transaction costs directly related to the acquisition were capitalized. Intangible assets amounted to $ 2.8 million as acquired ANDA intangible assets. The payment was allocated to the acquired intangible assets based on relative fair value, which was determined using Level 3 unobservable inputs. The ANDA will be amortized in full over its useful life of seven years and will be tested for impairment when events or circumstances indicate that the carrying value of the asset may not be recoverable. No such triggering events were identified during the period from the date of acquisition to December 31, 2023 , and therefore no impairment loss was recognized for the year ended December 31, 2023 . During the second quarter of fiscal 2023, the Company acquired two ANDAs and one pipeline product from the Chapter 7 Trustee for the estates of Akorn Holding Company and certain of its affiliates for total consideration of $ 4.8 million. The transaction was funded from cash on hand. This transaction was accounted for as an asset acquisition and the transaction costs directly related to the acquisition were capitalized. The product portfolio included two commercial products and one pipeline product. The Company recognized $ 4.3 million as acquired ANDA intangible assets. The payment was allocated to the acquired intangible assets and in-process research and development based on relative fair value, which was determined using Level 3 unobservable inputs. The ANDAs will be amortized in full over its useful life of seven years and will be tested for impairment when events or circumstances indicate that the carrying value of the asset may not be recoverable. No such triggering events were identified during the period from the date of acquisition to December 31, 2023, and therefore no impairment loss was recognized for the year ended December 31, 2023. 94 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 On July 21, 2022, we acquired four ANDAs from Oakrum Pharma, LLC for total consideration of $ 8.0 million plus an immaterial amount for the purchase of finished goods inventory. The transaction was funded from cash on hand. We accounted for this transaction as an asset acquisition and capitalized the transaction costs directly related to the acquisition. The product portfolio included one commercial product, one approved product with a launch completed in September and two filed products, with approval pending. We recognized $ 7.2 million as acquired ANDA intangible assets and $ 1.2 million as research and development expense because certain of the generic products have significant remaining work required in order to be commercialized and the products do not have an alternative future use. The payment was allocated to the acquired intangible assets and in-process research and development based on relative fair value, which was determined using Level 3 unobservable inputs. We used the present value of the estimated cash flows related to the products, using a discount rate of 13 % to determine the fair value of the acquired intangible assets and in-process research and development. The inventory acquired was immaterial. Contingent liabilities are accrued when they are both estimable and probable. We accrued $ 0.2 million in contingent payments due to a third party upon the launch of a product completed in September. This was accrued and recorded in the fair value of acquired intangible assets as it was probable at the acquisition date and has been paid in 2022. The ANDAs will be amortized in full over its useful life of seven years and will be tested for impairment when events or circumstances indicate that the carrying value of the asset may not be recoverable. No such triggering events were identified during the period from the date of acquisition to December 31, 2023, and therefore no impairment loss was recognized for the year ended December 31, 2023. In April 2021, we acquired three NDAs and an ANDA and certain related inventories from Sandoz, Inc. for total consideration of $ 20.7 million. We also incurred and paid $ 0.4 million in transaction costs directly related to the acquisition. The acquisition was funded via borrowings under our Revolver. We accounted for this transaction as an asset acquisition and capitalized the transaction costs directly related to the acquisition. We recognized $ 11.4 million as acquired intangible assets and $ 9.7 million of inventory at fair value, including $ 0.6 million of API, $ 1.0 million of sample inventory, and $ 8.1 million in finished goods inventory. In order to determine the fair value of the intangible assets, we used the present value of the estimated cash flows related to the product rights using a discount rate of 10 %, which are level 3 unobservable inputs. The fair value of the inventory was determined based on the estimated selling price to be generated from the finished goods, less costs to sell, including a reasonable margin, which are level 3 unobservable inputs. The intangible assets are being amortized in full over a useful life of seven years and are 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 December 31, 2023 and therefore no impairment loss was recognized for the years ended December 31, 2022 and 2023. 11. MEZZANINE AND STOCKHOLDERS’ EQUITY Stockholders’ Equity Authorized shares The Company is 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 December 31, 2023 and 2022. There were 20.7 million and 20.5 million shares of common stock issued and outstanding as of December 31, 2023, respectively, and 17.6 million and 17.5 million shares of common stock issued and outstanding as of December 31, 2022, respectively. Public Offering In May 2023, through a public offering, the Company completed the issuance and sale of 2,183,545 shares of ANI common stock, resulting in net proceeds after issuance costs of $ 80.6 million. During 2021, the Company issued 1.5 million shares related to a public offering of the Company's common stock and 2.5 million shares as consideration for the acquisition of Novitium. 95 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Class C Special Stock There were 11 thousand shares of class C special stock issued and outstanding as of December 31, 2023 and 2022. 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 the Company's 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 the Company's assets upon liquidation, dissolution, or winding-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, the Company entered into an Equity Commitment and Investment Agreement with Ampersand 2020 Limited Partnership (the “PIPE Investor”), pursuant to which the PIPE Investor agreed to purchase, 25,000 shares of the Company's 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 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 the Company's control. The Company 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 the Company's common stock. The PIPE Shares are convertible into the Company's common shares at the conversion price of $ 41.47 (i) beginning two years 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 the Company's 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 December 31, 2023, the PIPE shares are currently convertible into a maximum of 602,901 shares of the Company's common stock. In case of a liquidation event, the holder of the PIPE Shares will be entitled to receive, in preference to holders of the Company's 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 the Company's common stock. The PIPE Shares will have voting rights, voting as one series with the Company's 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 the Company , 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 the Company's common stock. There were 25,000 shares of Series A convertible preferred stock outstanding as of December 31, 2023 and 2022. 96 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 12. 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 ESPP, and performance stock units, using the more dilutive of the treasury stock or the two-class method. For periods of net loss, diluted loss per share is calculated similarly to basic loss per share. 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 years ended December 31, 2023, 2022, and 2021 are calculated for basic and diluted earnings (loss) per share as follows: Basic Diluted (in thousands, except per share amounts) Years Ended December 31, Years Ended December 31, 2023 2022 2021 2023 2022 2021 Net income (loss) available to common shareholders $ 17,154 $ ( 49,521 ) $ ( 42,793 ) $ 17,154 $ ( 49,521 ) $ ( 42,793 ) Earnings allocated to participating securities ( 1,679 ) — — ( 1,663 ) — — Net income (loss) available to common shareholders $ 15,475 $ ( 49,521 ) $ ( 42,793 ) $ 15,491 $ ( 49,521 ) $ ( 42,793 ) Basic Weighted-Average Shares Outstanding 18,001 16,260 12,596 18,001 16,260 12,596 Dilutive effect of stock options, ESPP, and performance stock units 193 — — Diluted Weighted-Average Shares Outstanding 18,194 16,260 12,596 Earnings (loss) per share $ 0.86 $ ( 3.05 ) $ ( 3.40 ) $ 0.85 $ ( 3.05 ) $ ( 3.40 ) The number of anti-dilutive shares, which have been excluded from the computation of diluted earnings (loss) per share, were 2.4 million, 2.6 million, and 1.7 million for the years ended December 31, 2023, 2022, and 2021, respectively. For the years ended December 31, 2022 and 2021, all potentially dilutive shares were anti-dilutive and excluded from the calculation of diluted loss per share because the Company reported a net loss . 97 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 13. STOCK-BASED COMPENSATION Employee Stock Purchase Plan In July 2016, the Company commenced administration of the ANI Pharmaceuticals, Inc. 2016 ESPP. As of December 31, 2023 there are 0.1 million shares of common stock available for issuance under the ESPP. Under the ESPP, participants can purchase shares of common stock at a 15 % discount. The Company issued 38 thousand, 29 thousand, and 14 thousand shares in the years ended December 31, 2023, 2022, and 2021, respectively. The following table summarizes ESPP expense incurred under the 2016 Employee Stock Purchase Plan and included in the consolidated statements of operations: (in thousands) Years Ended December 31, 2023 2022 2021 Selling, general, and administrative $ 360 $ 222 $ 87 Cost of sales 60 50 15 Research and development 47 41 21 $ 467 $ 313 $ 123 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 the Company's stockholders at the 2022 Annual Meeting of Stockholders (the “Annual Meeting”) held on April 27, 2022. Prior to this approval, the Company granted equity-based incentive awards under the Sixth Amended and Restated 2008 Stock Incentive Plan (the “2008 Plan”), which was renamed, amended and restated to the 2022 Plan. The 2022 Plan, among other things, increased the number of shares reserved for issuance thereunder by 1,150,000 shares. As of December 31, 2023, 1.1 million shares of common stock were available for issuance under the 2022 Plan. On May 23, 2023, the Company’s stockholders approved an amendment to the 2022 Plan (such amendment, the “2023 Stock Plan Amendment”). Subject to adjustment, the 2023 Stock Plan Amendment increased the number of shares reserved for issuance under the 2022 Plan by 750,000 shares. From time to time, the Company may grant stock options to employees through an inducement grant outside of the 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 the 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 the stockholder approved equity plan as permitted under the Nasdaq Stock Market listing rules. The cost of equity-based service awards are measured based on the grant-date fair value of the award. The cost is recognized ratably over the period during which an employee is required to provide service in exchange for the award or the requisite service period. Stock-based compensation expense is recognized ratably over the vesting periods of the awards. The following table summarizes stock-based compensation expense incurred for stock options, restricted stock awards, performance-based restricted stock units, and Inducement Grants and included in the consolidated statements of operations: (in thousands) Years Ended December 31, 2023 2022 2021 Selling, general, and administrative $ 18,676 $ 13,094 $ 9,818 Research and development 863 710 543 Cost of sales 646 482 5 $ 20,185 $ 14,286 $ 10,366 98 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Income tax benefits of approximately $ 3.3 million, $ 1.7 million, and $ 1.0 million were recognized for stock-based compensation-related tax deductions in the 2023, 2022, and 2021 consolidated statements of operations, respectively. Stock Options Outstanding stock options granted to employees and consultants generally vest over a period of four years and have 10-year contractual terms. Outstanding stock options granted to non-employee directors generally vest over a period of one to four years and have 10-year contractual terms. For 2023, 2022, and 2021, the fair value of each option grant was estimated using the Black-Scholes option-pricing model, using the following assumptions: Years Ended December 31, 2023 2022 2021 Expected option life (years) 6.25 5.50 - 6.25 5.50 - 6.25 Risk-free interest rate 4.1 % 1.71 % - 2.83 % 0.68 % - 1.39 % Expected stock price volatility 49.0 % 48.4 % - 50.0 % 48.2 % - 49.5 % Dividend yield — — — The Company uses the simplified method to estimate the expected option life of options. The risk-free interest rate used is the yield on a U.S. Treasury note as of the grant date with a maturity equal to the estimated life of the option. The calculated estimated volatility rate is based on ANI's historical stock price. The Company has not issued a cash dividend on the common shares in the past nor does the Company have any current plans to do so in the future; therefore, an expected dividend yield of zero was used. 99 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 A summary of stock option activity under the 2022 Plan and Inducement Grants during the years ended December 31, 2023, 2022, and 2021 is presented below: (in thousands, except per share and remaining term data) Option Shares Weighted Average Exercise Price Fair Value Weighted Average Remaining Term (years) Aggregate Intrinsic Value Outstanding December 31, 2020 936 $ 48.44 7.1 $ 372 Granted 168 33.09 $ 15.71 Exercised ( 42 ) 40.25 552 Forfeited ( 19 ) 59.84 Expired ( 55 ) 55.59 Outstanding December 31, 2021 988 $ 45.56 6.6 $ 6,786 Granted 36 34.52 $ 16.82 Exercised ( 23 ) 30.03 153 Forfeited ( 47 ) 36.91 Expired ( 47 ) 55.07 Outstanding at December 31, 2022 907 $ 45.47 5.6 $ 3,868 Granted 3 41.84 $ 22.12 Exercised ( 189 ) 44.09 2,894 Forfeited ( 21 ) 33.45 Expired ( 11 ) 55.15 Outstanding at December 31, 2023 689 $ 46.05 4.9 $ 8,370 Exercisable at December 31, 2023 580 $ 48.75 4.5 $ 5,815 As of December 31, 2023, there was $ 1.6 million of total unrecognized compensation cost related to non-vested stock options granted under the 2022 Plan and Inducement Grant. The cost is expected to be recognized over a weighted-average period of 1.1 years. During the year ended December 31, 2023, ANI received $ 8.3 million in cash from the exercise of stock options and recorded approximately $ 0.2 million tax provision related to these exercises. During the year ended December 31, 2022, ANI received $ 0.7 million in cash from the exercise of stock options and recorded a $ 0.1 million tax provision related to these exercises. During the year ended December 31, 2021, ANI received $ 1.7 million in cash from the exercise of stock options and recorded a $ 0.1 million tax provision related to these exercises. Restricted Stock Awards Restricted stock awards (“RSAs”) granted to employees generally vest over a period of four years . RSAs granted to non-officer directors generally vest over a period of one year . Shares of common stock delivered to employees and directors will be unrestricted upon vesting. During the vesting period, the recipient of the restricted stock has full voting rights as a stockholder and would receive dividends, if declared, even though the restricted stock remains subject to transfer restrictions and will generally be forfeited upon termination of the officer prior to vesting. The fair value of each RSA is based on the market value of the Company's stock on the date of grant. 100 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 A summary of RSA activity under the Plan during the years ended December 31, 2023, 2022, and 2021 is presented below: (in thousands, except per share and remaining term data) Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Term (years) Unvested at December 31, 2020 352 $ 48.14 2.7 Granted 541 33.02 Vested ( 125 ) 48.32 Forfeited ( 61 ) 48.16 Unvested at December 31, 2021 707 $ 36.52 2.8 Granted 748 32.76 Vested ( 245 ) 36.99 Forfeited ( 69 ) 38.08 Unvested at December 31, 2022 1,141 $ 33.86 2.6 Granted 674 43.30 Vested ( 383 ) 34.59 Forfeited ( 81 ) 38.10 Unvested at December 31, 2023 1,351 $ 38.11 2.4 As of December 31, 2023, there was $ 41.5 million of total unrecognized compensation cost related to non-vested RSAs granted under the Plan, which is expected to be recognized over a weighted-average period of 2.4 years. Performance-Based Restricted Stock Units Awards may also be issued in the form of PSUs. PSUs represent the right to receive a number of shares of Company common stock, contingent upon the achievement of specified performance objectives during a specified performance period. PSUs granted to date vest over a three -year performance period. On February 28, 2023, as part of the Company's equity compensation program, PSUs were granted to certain executives. Of these PSUs, 50 % were market performance-based restricted stock units (“MPRSUs”), vesting of which is contingent upon the Company meeting certain total shareholder return (“TSR”) levels as compared to a select peer group over the over three years starting January 1, 2023. The MPRSUs are also subject to the recipient’s continued employment or service through December 31, 2025. The MPRSUs cliff vest at the end of the three -year period and have a maximum potential to vest at 200 % ( 85,099 shares) based on TSR performance. The related share-based compensation expense is determined based on the estimated fair value of the underlying shares on the date of grant and is recognized straight-line over the vesting term. The estimated grant date fair value per share of the MPRSUs was $ 68.65 and was calculated using a Monte Carlo simulation model. These MPRSUs are included at 100 % of the estimate number of shares at the end of the three -year performance period and are reflected under “Granted” in the table below. The other 50 % of the PSUs were performance based restricted stock units (“PRSUs”), vesting of which is contingent upon the Company meeting certain adjusted non-GAAP year-on-year EBITDA growth rates over the over three years starting January 1, 2023. The PRSUs are also subject to the recipient’s continued employment or service through December 31, 2025. The PRSUs cliff vest at the end of the three-year period and have a maximum potential to vest at 200 % ( 85,099 shares) based on adjusted non-GAAP year-on-year EBITDA growth rates. The related share-based compensation expense is determined based on the estimated fair value of the underlying shares on the date of grant and is recognized straight-line over the vesting term. The Company analyzed progress on the performance goals to assess the likelihood of achievement. The estimated grant date fair value per share of the PRSUs was $ 41.84 based on the closing price of the stock on the date of grant. These PRSUs are included at 100 % of the estimated number of shares at the end of the three -year performance period and are reflected under “Granted” in the table below. 101 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 A summary of PSU activity under the Plan during the years ended December 31, 2023 and 2022 is presented below: (in thousands, except per share and remaining term data) Shares Weighted Average Grant Date Fair Value Weighted Average Remaining Term (years) Unvested at December 31, 2022 — $ — — Granted 85 41.84 Vested — — Forfeited ( 1 ) 41.84 Unvested at December 31, 2023 84 $ 41.84 2.0 As of December 31, 2023, there was $ 2.5 million of total unrecognized compensation cost related to non-vested PSUs granted under the Plan, which is expected to be recognized over a weighted-average period of 2.0 years. 14. INCOME TAXES On August 6, 2018, ANI Pharmaceuticals Canada Inc. (“ANI Canada”) acquired all the issued and outstanding equity interests of WellSpring in a non-taxable transaction. Following the consummation of the transaction, WellSpring was merged into ANI Canada. For U.S. Federal and state income tax purposes, ANI Canada is not part of ANI’s consolidated group; rather, ANI Canada is subject to income taxes only in Canada and solely based on its stand-alone operations. The foreign current and foreign deferred provisions (benefits) below represent the Company's tax provision (benefit) from the Canadian and Indian taxing jurisdictions. The Company is required to establish a valuation allowance is required to be established for deferred tax assets if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Projected future taxable income and tax planning strategies in making this assessment. As of December 31, 2023 and 2022, the consolidated valuation allowance was $ 0.4 million and $ 0.4 million, respectively, related solely to deferred tax assets for net operating loss carryforwards in certain U.S. state jurisdictions. Total income tax expense (benefit) for income taxes consists of the following for the years ended December 31: (in thousands) 2023 2022 2021 Current income tax provision Federal $ 9,117 $ 152 $ 1,296 State 3,534 249 1,320 Foreign 26 66 691 Total 12,677 467 3,307 Deferred income tax benefit Federal ( 7,601 ) ( 13,382 ) ( 12,163 ) State ( 3,946 ) ( 1,722 ) ( 5,122 ) Foreign ( 29 ) ( 128 ) 336 Total ( 11,576 ) ( 15,232 ) ( 16,949 ) Change in valuation allowance ( 8 ) ( 4 ) 187 Total expense (benefit) for income taxes $ 1,093 $ ( 14,769 ) $ ( 13,455 ) 102 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 The difference between expected income tax expense (benefit) from applying U.S. Federal statutory tax rates to the pre-tax income (loss) and actual income tax expense (benefit) relates primarily to the effect of the following: As of December 31, 2023 2022 2021 US Federal statutory rate 21.0 % 21.0 % 21.0 % State taxes, net of Federal benefit 4.8 % 3.2 % 3.3 % Foreign taxes 0.0 % 0.1 % ( 1.0 ) % Change in valuation allowance 0.0 % — % ( 0.3 ) % Stock-based compensation 10.8 % ( 1.4 ) % ( 1.7 ) % Non-deductible costs 2.1 % ( 0.5 ) % ( 0.8 ) % Change in state apportionment factors, state and foreign rates ( 11.8 ) % ( 0.1 ) % 5.5 % Research and experimentation and charitable credits ( 19.0 ) % 1.4 % 0.9 % Transfer pricing and other ( 2.4 ) % ( 0.1 ) % ( 2.9 ) % Effective income tax rate 5.5 % 23.6 % 24.0 % Deferred income taxes reflect the net tax effects of differences between the bases of assets and liabilities for financial reporting and income tax purposes. Deferred income tax assets and liabilities consisted of the following: As of December 31, (in thousands) 2023 2022 Deferred tax assets: Accruals and advances $ 12,470 $ 9,233 Stock-based compensation 6,013 6,041 Accruals for chargebacks and returns 17,358 15,344 Inventories 4,569 5,292 Intangible assets 40,193 33,431 Net operating loss carryforwards 2,900 5,994 Capitalized research expenditures 11,294 4,708 Other 7,450 11,840 Total deferred tax assets $ 102,247 $ 91,883 Deferred tax liabilities: Depreciation $ ( 5,658 ) $ ( 5,776 ) Other liabilities ( 5,440 ) ( 4,298 ) Total deferred tax liabilities $ ( 11,098 ) $ ( 10,074 ) Valuation allowance ( 438 ) ( 446 ) Deferred tax assets, net of deferred tax liabilities and valuation allowance $ 90,711 $ 81,363 As of December 31, 2023, U.S. federal net operating loss carryforwards were approximately $ 8.0 million, all of which arose as a result of the 2013 merger with BioSante Pharmaceuticals, Inc. Net operating loss carryforwards related to the 2013 merger, if not used, expire in annual increments through 2033 and are limited on an annual basis as prescribed by Section 382 of the U.S. Internal Revenue Code; and the current annual limitation is approximately $ 0.8 million per year. Additionally, as of December 31, 2023, there were total net operating losses in various states of approximately $ 13.0 million which begin to expire through 2042, and in Canada of $ 1.0 million that expire through 2038. 103 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 The Company is subject to income taxes in numerous jurisdictions in the U.S., Canada, and India. Significant judgment is required in evaluating the tax positions and determining the provision for income taxes. Liabilities are established for tax-related uncertainties based on estimates of whether, and the extent to which, additional taxes will be due. These liabilities are established when it is believed that certain positions might be challenged despite the belief that our tax return positions are fully supportable. These liabilities are adjusted in light of changing facts and circumstances, such as the outcome of a tax audit. The provision for income taxes includes the impact of changes to the liability that is considered appropriate. There were no material uncertain income tax positions identified as of December 31, 2023 and 2022. The Company is subject to income tax audits in all jurisdictions for which tax returns are filed. Tax audits by their nature are often complex and can require several years to complete. All of the Company's income tax returns remain subject to examination by tax authorities due to the availability of net operating loss carryforwards. 15. COMMITMENTS AND CONTINGENCIES Operating Leases All existing leases as of December 31, 2023 are classified as operating leases. As of December 31, 2023, there are 14 operating leases for facilities and office equipment with remaining terms expiring from 2025 through 2028 and a weighted average remaining lease terms of 3.9 years and 2.6 years, as of December 31, 2023 and 2022, respectively. During April 2023, the Company entered into a lease agreement for additional warehouse space in East Windsor, New Jersey. Additionally, during October 2023, the Company entered into an amendment for the Middleton, Wisconsin location which expanded the Company's square footage and also extended the termination date to December 2028. Many of the operating leases have fair value renewal options, none of which are considered certain of being exercised or included in the minimum lease term. Leases with an initial term of twelve months or less are not recorded on the balance sheet, and the Company does not separate lease and non-lease components of contracts. The Company’s lease agreements do not provide for determination of the interest rate implicit in the lease. Therefore, the Company used a benchmark approach to derive an appropriate incremental borrowing rate. The Company’s incremental borrowing rate is the rate of interest that the lessee would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. The Company benchmarked itself against other companies of similar credit ratings and comparable quality and derived an incremental borrowing rate, which was used to discount its lease liabilities. The weighted average incremental borrowing rates as of December 31, 2023 and 2022 is 8.12 % and 3.99 %, respectively. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. In addition, the Company does not have any finance leases, any sublease arrangements, or any leases where the Company is considered the lessor. Lease expense consisted of the following for the years ended December 31: (in thousands) 2023 2022 2021 Operating lease costs $ 2,031 $ 701 $ 240 Variable lease costs 221 236 48 Total lease costs $ 2,252 $ 937 $ 288 104 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 The table below reconciles the fixed component of the undiscounted cash flows for each of the first five years and the total remaining years to the lease liabilities recorded on the Consolidated Balance Sheet as of December 31, 2023: (in thousands) 2024 $ 1,967 2025 1,610 2026 1,290 2027 1,289 2028 506 Thereafter — Total minimum lease payments 6,662 Less: effects of discounting ( 990 ) Present value of future minimum lease payments 5,672 Less: current lease liability, included in accrued expenses and other ( 1,561 ) Non-current lease liability, included in other non-current liabilities $ 4,111 Government Regulation The Company's 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”), 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 ANI's products. The DEA and NCB maintain oversight over products that are considered controlled substances. Unapproved Products Three products, Esterified Estrogen with Methyltestosterone (“EEMT”), Opium Tincture, Thyroid Tablets, and are marketed without approved NDAs or ANDAs. During the years ended December 31, 2023, 2022, and 2021, net revenues for Esterified Estrogen with Methyltestosterone (“EEMT”), Opium Tincture and Thyroid Tablets products totaled $ 22.4 million, $ 14.2 million, and $ 16.2 million, respectively. The Company obtained the rights to Hyoscyamine, a product without an approved NDA as of December 27, 2023, which we plan to launch commercially in early 2024 (see further discussion below). The FDA's policy with respect to the continued marketing of unapproved products appears in the FDA's September 2011 Compliance Policy Guide Sec. 440.100 titled “Marketed New Drugs without Approved NDAs or ANDAs.” Under this policy, the FDA has stated that it will follow a risk-based approach with regard to enforcement against marketing of unapproved products. The FDA evaluates whether to initiate enforcement action on a case-by-case basis, but gives higher priority to enforcement action against products in certain categories, such as those with potential safety risks or that lack evidence of effectiveness. We continue to believe that, so long as we comply with applicable manufacturing standards, the FDA will continue to operate on a risk-based approach and will not take action against us. However, we can offer no assurance that the FDA will continue to follow this approach or that it will not take a contrary position with any individual product or group of products. If the FDA were to move away from the risk-based approach to enforcement against marketing of unapproved products, we may be required to seek FDA approval for these products or withdraw such products from the market. If we decide to withdraw the products from the market, net revenues for generic pharmaceutical products would decline materially, and if we decide to seek FDA approval, we would face increased expenses and might need to suspend sales of the products until such approval was obtained, and there are no assurances that we would receive such approval. 105 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 One group of products that the Company manufactured on behalf of a contract customer, Hyoscyamine, was marketed by that customer without an approved NDA. Contract manufacturing revenues for Hyoscyamine, for the years ended December 31, 2023, 2022, and 2021 were $ 1.9 million, $ 2.6 million, and $ 2.4 million , respectively. On December 27, 2023 the Company purchased the intellectual property and product rights to Hyoscamine from Alvogen, Inc. (Note 10). Legal proceedings The Company is 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. While we believe that we have valid claims and/or defenses in the litigation and other matters described below, litigation is inherently unpredictable, particularly where the damages sought are substantial or indeterminate or when the proceedings, investigations or inquiries are in the early stages, 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. 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 many 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. 106 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Commercial Litigation 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 were substantively identical. The plaintiffs in these actions alleged 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. Under the terms of the 2020 Asset Purchase Agreement, Amerigen agreed to indemnify ANI for certain liabilities relating to Bystolic, including liabilities that arose prior to closing of the asset purchase. 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. The cases were 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 in federal court in the Southern District of New York, on that date. The newly amended complaints contained substantially similar claims. On April 19, 2022, the Company and other defendants filed motions to dismiss the newly amended complaints. After full briefing and oral argument, on February 21, 2023, the court granted the Company and the defendants’ motion to dismiss all actions with prejudice. Plaintiffs filed an appeal in the Second Circuit. Oral arguments were held on December 6, 2023 and a decision from the court is pending. ANI continues to dispute any liability in this matter. On March 24, 2021, Azurity Pharmaceuticals, Inc. (“Azurity”) filed a complaint in the United States District Court for the District of Minnesota against ANI, 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, ANI paid Azurity $ 1.9 million of royalties from past sales and will pay Azurity a royalty equal to 20 % of gross margin of sales of the ANI product for a contractually defined term. 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, 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 sought injunctive relief , attorneys' fee and costs. On May 26, 2022, the parties’ respective claims and counterclaims were dismissed pursuant to a confidential settlement agreement. 107 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 On October 3, 2022, Azurity filed a complaint in the United States District Court for the District of New Jersey against Novitium, seeking a declaratory judgment that Novitium’s manufacture, use, sale, importation and/or offer to sell Bionpharma Inc.’s (“Bionpharma”) enalapril maleate oral solution drug product (the “Product”) would infringe U.S. Patents Nos. 11,040,023 and 11,141,405 (the “Novitium Action”). The complaint sought injunctive relief, and an award of Azurity’s costs and expenses. On October 12, 2022, Bionpharma filed a motion in the New Jersey court to intervene on Novitium’s behalf in the litigation and on October 14, 2022, Novitium and Bionpharma jointly moved to transfer venue to the District of Delaware. Transfer was granted on January 20, 2023. On March 27, 2023, the transferred Novitium Action (assigned Delaware Civil Action No. 23-163-MSG) was consolidated with the Delaware Third Wave Suits against Bionpharma (Civil Action Nos. 21-1286-MSG, 21-1455-MSG), which include Azurity’s infringement claims against Bionpharma involving the same patents asserted in the Novitium Action, as well as Bionpharma’s antitrust claims against Azurity. On August 3, 2023, Azurity filed an amended complaint against Novitium seeking damages for supplying Bionpharma's ANDA product. On November 14, 2023, the court dismissed all of Azurity's claims against Novitium with prejudice and dismissed Novitium as a party from the Delaware Third Wave Suits. Bionpharma has agreed to indemnify Novitium under the terms of its manufacturing and supply agreement for any damages, costs, and expenses relating to actual or alleged infringement of intellectual property rights or sale of the Product by Bionpharma. On September 29, 2023, Orphalan SA ("Orphalan") filed a complaint in the United States District Court for the District of Delaware against Novitium, asserting that Novitium's proposed triethylenetetramine tetrachloride drug product, which is subject to Novitium's Abbreviated New Drug Application No. 218493, infringes U.S. Patent Nos. 10,988,436 and 11,072,577. The complaint seeks damages, injunctive relief, attorneys' fees and costs. On December 1, 2023, Orphalan voluntarily dismissed the action without prejudice. Novitium disputes any liability in this matter. On November 21, 2023, Harmony Biosciences, LLC, Bioprojet Societe Civile de Recherche and Bioprojet Pharma SAS filed a compliant in the United States District Court for the District of Delaware against Novitium and certain other defendants named in the complaint, asserting, among other things, that Novitium's proposed pitolisant hydrochloride drug product, which is subject to Novitium's Abbreviated New Drug Application No. 218495, infringes U.S. Patent Nos 8,207,197, 8,354,430 and 8,486,947. The complaint seeks damages, injunctive relief, attorneys' fees and costs. Novitium disputes any liability in this matter. Ranitidine Related Litigation State of New Mexico Litigation . In July 2020, ANI and Novitium were served with a complaint brought in the First Judicial Court, County of Santa Fe, State of New Mexico by the Office of the Attorney General of the State of New Mexico against manufacturers and sellers of ranitidine products. The complaint asserted a public nuisance claim and a negligence claim against the generic ranitidine manufacturer defendants, including ANI and Novitium. As damages for the nuisance claim, New Mexico asked that the defendants fund this medical monitoring program. With respect to the nuisance claim, New Mexico asserted that it paid for ranitidine products through state-funded insurance and health-care programs. 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 was named as a defendant in the amended complaint. On September 1, 2023, the court entered an order dismissing Novitium without prejudice. 108 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Federal Court Personal Injury Litigation . 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 the existing multi-district litigation concerning ranitidine-containing drugs pending in the Southern District of Florida, In re Zantac MDL , 20 MDL 2924 (the "MDL"). 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 MPIC 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. In addition, by opinion and order dated December 6, 2022, the district court granted the brand manufacturer defendants’ Daubert motion to exclude the plaintiffs’ expert testimony on general causation for the “designated cancers” that the plaintiffs’ leadership team claimed to be caused by ranitidine. The district court also granted the brand manufacturer defendants’ motion for summary judgment because the plaintiffs had failed to produce admissible primary evidence of general causation. The plaintiffs have appealed to the Eleventh Circuit Court of Appeals. ANI and Novitium were named in other individual personal injury complaints filed in the MDL 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). Each of the plaintiffs in the five pending cases alleges a cancer diagnosis prior to the time that ANI sold ranitidine, and ANI informally sought dismissal from these cases on that basis. ANI was voluntarily dismissed from the Cooper , Lineberry and Lovette actions on November 20, 2020, from the Bird action on March 15, 2021, and from the Hightower action on March 29, 2021. Prior to the district court’s July 8, 2021 preemption decision, Novitium had been named in 158 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 and Novitium’s product was voluntarily recalled in October 2019. Out of the 158 short form complaints, approximately 114 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. Two of those 114 plaintiffs dismissed Novitium from their short form complaints. 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. Following the district court’s Daubert decision, plaintiffs began filing additional short form complaints in the MDL. Novitium currently is named as a defendant in more than 700 short form complaints. The plaintiffs have taken multiple appeals from decisions issued by the district court in the MDL to the Eleventh Circuit. On September 8, 2023, the Eleventh Circuit remanded a subset of the MDL appeals back to the district court for entry of final judgments pursuant to Rule 58. The defendants filed a motion with the Eleventh Circuit to remand a similarly situated appeal for similar entry of a final judgment. In addition, the defendants are seeking a stay from the Eleventh Circuit of all non-remanded related appeals in order to have all of the related appeals decided together. The district court has entered final judgments and the appeals are now pending before the Eleventh Circuit. ANI and Novitium dispute any liability in these matters. 109 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 State Court Personal Injury Litigation Illinois. 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 to 2019. At this point, the allegations show that the plaintiff’s alleged cancer injury could not have come from a Novitium product. The Ross action was consolidated with the coordinated proceedings in Illinois, which have been dismissed, as discussed below. In August 2022, the Keller Postman law firm commenced six multi-plaintiff actions in Illinois state court naming generic ranitidine manufacturers, including ANI and/or Novitium, as defendants. Those cases are: (1) Jodee Gillespie v. Walgreen Co., et. al., Circuit Court of the Third Judicial Circuit, Madison County, Illinois, Case No. 2022LA001007 (naming both Novitium and ANI); (2) John Jackson v. Walgreen Co., et. al., Circuit Court of the Third Judicial Circuit, Madison County, Illinois, Case No. 2022LA001012 (naming Novitium); (3) Ayesha Salahuddin v. Walgreen Co., et. al., Circuit Court of the Twentieth Judicial Circuit, St. Clair County, Illinois, Case No. 22LA0709 (naming Novitium); (4) Lashanda McGruder v. Walgreen Co., et. al., Circuit Court of the Third Judicial Circuit, Madison County, Illinois, Case No. 22LA0710 (naming both Novitium and ANI); (5) Richard Devriendt v. Walgreen Co., et. al., Circuit Court of Cook County, Illinois, Case No. 2022L007429 (naming Novitium); (6) Anthony Stigger v. Walgreen Co., et. al., Circuit Court of Cook County, Illinois, Case No. 2022L007396 (naming both Novitium and ANI). The complaints allege causes of action for failure to warn, design defect, general negligence, loss of consortium and wrongful death. Pursuant to an Order of the Illinois Supreme Court dated October 25, 2022, the pending ranitidine personal injury actions in Illinois have been consolidated in Cook County for coordinated pre-trial proceedings. Plaintiffs filed a master long-form complaint on March 9, 2023 naming Novitium as a defendant. ANI is not named as a defendant. The Keller Postman firm has confirmed that its clients are no longer pursuing claims against ANI. When the court ruled the cases needed to be re-filed as single-plaintiff cases, Novitium was never served. The counts in the master complaint include strict liability for failure to warn/design defects, general negligence, negligent misrepresentation, negligent storage and transport, apparent manufacturer liability, common law fraud, unjust enrichment, civil conspiracy, and breach of express and implied warranties. The complaint further alleges violations of the Illinois Consumer Fraud Act. Pursuant to the court’s standing order, the generic defendants filed a motion to dismiss pursuant to IL 2-615 (failure to state a claim on the face of the complaint) on April 13, 2023, claiming preemption by federal law. On August 10, 2023, the court dismissed all claims against the generic defendants, including Novitium, with prejudice on preemption grounds. 110 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 California. In August and September 2022, the Keller Postman law firm commenced seven multi-plaintiff actions in California state court, Alameda County, naming generic ranitidine manufacturers, including ANI and/or Novitium, as defendants. Those cases are: (1) Carlos Ascencio v. ANI Pharmaceuticals, et. al., Superior Court of California, County of Alameda, Case. No. 22CV016230 (naming both Novitium and ANI); (2) Andre Lebeau v. Actavis Mid Atlantic, LLC et. al., Superior Court of California, County of Alameda, Case No. 22CV016448 (naming Novitium); (3) Roque Torres v. ANI Pharmaceuticals, Inc., et. al., Superior Court of California, County of Alameda, Case No. 22CV016338 (naming both Novitium and ANI); (4) Deborah Hinds v. ANI Pharmaceuticals, Inc., et. al., Superior Court of California, County of Alameda, Case No. 22CV016123 (naming both Novitium and ANI); (5) Mark Cruz v. ANI Pharmaceuticals, Inc., et. al., Superior Court of California, County of Alameda, Case No. 22CV016338 (naming both Novitium and ANI); (6) Bent Olsen v. ANI Pharmaceuticals, Inc., et. al., Superior Court of California, County of Alameda, Case No. 22CV016402 (naming both Novitium and ANI); (7) John Norman v. Actavis Mid Atlantic, LLC, et. al., Superior Court of California, County of Alameda, Case No. 22CV018334 (naming Novitium). The complaints allege causes of action for failure to warn, design defect, general negligence, loss of consortium and wrongful death. By stipulation and order dated December 28, 2022, the cases were transferred to an existing civil case coordination docket for pretrial proceedings (JCCP) pending in Alameda County. On January 19, 2023, the court ordered that counsel for the plaintiffs must dismiss the individual plaintiffs (other than the first-named plaintiff) from each of the multi-plaintiff complaints and that each of the dismissed plaintiffs must re-file their claims in a single plaintiff complaint. On September 21, 2023, the plaintiff leadership filed a master complaint in the JCCP. The master complaint does not name any generic defendants. However, the short form complaints allow individual plaintiffs to name "other defendants," leaving open the option for individual plaintiffs to name generic manufacturers as defendants. The master complaint alleges strict liability (design defect and failure to warn), negligent failure to warn, and general negligence. In December 2023, the Keller Postman firm filed approximately 200 individual plaintiff short form complaints in the JCCP that name generic defendants. Novitium is named in 28 of the short form complaints which reference the allegations for the master complaint. ANI is not named. Pennsylvania. In September 2022, two single-plaintiff complaints were filed in Pennsylvania state court, Philadelphia County, naming Novitium as a defendant: (1) William Titus v. Glaxo SmithKline LLC, et. al., Court of Common Pleas, Philadelphia County, Pennsylvania, Case No. 220902548; and (2) Jodi Woodard v. Ajanta Pharma USA, Inc., et. al., Court of Common Pleas, Philadelphia County, Pennsylvania, Case No. 220902329. These complaints allege causes of action for negligence, failure to warn, negligent storage and transportation, breach of express and implied warranties, negligent misrepresentation, and fraud. On February 16, 2023, the Pennsylvania plaintiffs filed a consolidated long-form complaint against the generic defendants, Plaintiffs v. Actavis, et. al. Civil Action No. 1364. The long-form complaint names Novitium as a defendant. The long form complaint asserts causes of action for negligence, failure to warn, negligent storage and transportation, breach of express warranties, breach of implied warranties, negligent misrepresentation, fraud, strict products liability, wrongful death and survivor actions, and loss of consortium. The complaint includes a prayer for punitive damages. The generic defendants filed their preliminary objections to Plaintiffs’ consolidated long-form generic complaint on March 20, 2023. The court sustained the generics’ objection that plaintiffs’ failure to warn/design defect claims were preempted by federal law; therefore, all allegations related to failure to warn/design defects are dismissed. The court also sustained the generics’ preliminary objections relating to the counts of strict liability-design defect and breach of implied warranty to the extent Pennsylvania substantive law applies. The court noted the substantive law of another state may not conflict with federal law, and, further, strict liability and breach of implied warranty causes of action of another state may apply in individual cases. This is a determination that can only be made after short form complaints are filed. It is the generics’ position that the court’s ruling on the preliminary orders effectively dismissed the generics from the case unless and until a non-resident plaintiff names a generic in a short form complaint. Out of an abundance of caution, however, the generics, including Novitium, all filed answers to the long form complaint in June 2023. In January 2024, plaintiffs filed short form complaints naming generic defendants, including Novitium in one complaint, Titus . ANI and Novitium dispute any liability in these 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. 111 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 16. PURIFIED CORTROPHIN GEL PRE-LAUNCH CHARGES In January 2016, the Company acquired the right, title and interest in the NDAs for Cortrophin Gel and Cortrophin-Zinc. Subsequently, the Company 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 ANI has 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, the purchase of materials commenced that were 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, the Company was 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. During the year ended December 31, 2021, the Company recognized $ 0.8 million of charges for the purchase of materials. Other charges were incurred directly related to the Cortrophin pre-launch commercialization efforts, including, but not limited to, sales and marketing and consulting expenses. During the year ended December 31, 2021, the Company incurred $ 14.0 million of these charges, which are included on the consolidated statements of operations as a selling, general, and administrative expense. There were no comparable expenses in 2023 and 2022 . 17. RELATED PARTY TRANSACTIONS On March 8, 2021, the Company entered into an Equity Commitment and Investment Agreement with the PIPE Investor, pursuant to which 25,000 shares were purchased for $ 1,000 per share and an aggregate purchase price of $ 25.0 million on November 19, 2021. The Chairman of the Company's board of directors is an operating partner of Ampersand Capital Partners, an affiliate of the PIPE Investor. In connection with the acquisition of Novitium, the Company entered into employment agreements with the two executives and founders of Novitium, Muthusamy Shanmugam, Head of R&D and COO of NJ Operations of ANI, and Chad Gassert, Sr. Vice President, Corporate Development and Strategy of ANI. Both serve as executive officers of the Company and Mr. Shanmugam also serves on the Company's board of directors. Mr. Shanmugam holds a minority interest in Scitus Pharma Services (“Scitus”), which provides clinical research services to Novitium, a majority interest in SS Pharma LLC (“SS Pharma”), which acquires and supplies API to Novitium, a minority interest in Nuray Chemical Private Limited (“Nuray”), which manufactures and supplies API to Novitium, and a majority interest in Esjay Pharma LLC (“Esjay”), which provided research and development and facilities consulting services through September 30, 2022. Mr. Gassert holds a minority interest in Scitus. A summary of payments to related parties is presented below: Years Ended December 31, (in thousands) 2023 2022 2021 (1) Scitus Pharma Services $ 3,646 $ 2,075 $ — SS Pharma LLC 8,235 3,669 — Esjay Pharma LLC — 101 25 Nuray Chemical Private Limited — 1,110 365 $ 11,881 $ 6,955 $ 390 ____________________ (1) Includes payments during the period from November 19, 2021 to December 31, 2021, subsequent to the acquisition of Novitium. 112 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 As of December 31, 2023, the outstanding balances due to Scitus and SS Pharma were $ 0.7 million and $ 0.6 million, respectively. There was no outstanding balance due to Nuray or Esjay at December 31, 2023. On December 12, 2023, the Company paid $ 12.5 million of cash consideration to the Company Members of Novitium for the achievement of the "ANDA Filing Earn-Out," as defined in the Novitium acquisition agreement, as discussed in Note 2. The Company paid Mr. Shanmugam and Esjay, and Mr. Gassert's company Chali Properties LLC, approximately $ 6.7 million and $ 1.9 million, respectively, for their portion of the cash consideration due to them as part of the Novitium acquisition. On February 22, 2024, the Company paid $ 12.5 million of cash consideration to the Company Members of Novitium for the achievement of the "Gross Profit Earn-Out," as defined in the Novitium acquisition agreement, as discussed in Note 2. The Company paid Mr. Shanmugam and Esjay, and Mr. Gassert's company Chali Properties LLC, approximately $ 6.7 million and $ 1.9 million, respectively, for their portion of the cash consideration due to them as part of the Novitium acquisition. 18. 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, the Company was organized as one operating and reporting segment. Prior period segment disclosures have been recast for the new segment presentation. Effective in the first quarter of 2022 and prospectively, in conjunction with the principal completion of the buildout of infrastructure in the areas of commercialization of rare disease therapies and the launch of Cortrophin Gel, it was determined that the Company has 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 Cortrophin Gel. The CODM evaluates the performance of the Company as two operating segments based on revenues and 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. The Company does not manage assets of the Company by operating segment and the CODM does not review asset information by operating segment. Accordingly, the Company does not present total assets by operating segment. 113 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 Financial information by reportable segment, including historical information that has been retroactively re-cast to reflect two reporting segments, is as follows: Year Ended December 31, (in thousands) 2023 2022 2021 Net Revenues Generics, Established Brands, and Other $ 374,699 $ 274,699 $ 216,136 Rare Disease 112,117 41,686 — Total net revenues $ 486,816 $ 316,385 $ 216,136 Segment earnings (loss) before interest, taxes, depreciation and amortization (“EBITDA”) and reconciliation to income (loss) before income taxes Generics, Established Brands, and Other $ 152,990 $ 78,958 $ 63,418 Rare Disease 12,498 ( 18,348 ) ( 18,571 ) Depreciation and amortization ( 59,791 ) ( 56,973 ) ( 47,252 ) Corporate and other unallocated expenses (1) ( 58,726 ) ( 38,920 ) ( 37,388 ) Total operating income (loss) $ 46,971 $ ( 35,283 ) $ ( 39,793 ) Interest expense, net ( 26,940 ) ( 28,052 ) ( 11,922 ) Other income (expense), net ( 159 ) 670 ( 4,343 ) Income (loss) before expense (benefit) for income taxes $ 19,872 $ ( 62,665 ) $ ( 56,058 ) ____________________ (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 consolidated statement of operations. Geographic Information Operations are located in the United States and India. The Company has ceased operations at the Oakville, Ontario, Canada location as of March 31, 2023. 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) Years Ended December 31, Location of Operations 2023 2022 2021 United States $ 486,251 $ 312,427 $ 211,893 Canada 565 3,958 4,243 Total Revenue $ 486,816 $ 316,385 $ 216,136 114 Table of Contents ANI Pharmaceuticals, Inc. and Subsidiaries Notes to the Consolidated Financial Statements For the years ended December 31, 2023, 2022, and 2021 The following table depicts the Company’s property and equipment, net according to geographic location as of: (in thousands) December 31, 2023 December 31, 2022 United States $ 43,163 $ 40,343 Canada (1) — 1,856 India 1,430 1,047 Total property and equipment, net $ 44,593 $ 43,246 ____________________ (1) Amounts as of December 31, 2023 and 2022 exclude the land and building at the Canada facility, which are classified as held for sale as of December 31, 2023 and 2022. These assets have a carrying value of $ 8.0 million. 19. SUBSEQUENT EVENTS On February 14, 2024, the Company granted RSA and PSU awards to officers and employees of the Company under the 2022 Plan. The Company granted 525,729 RSAs to employees and officers of the Company. These RSAs vest over four years . The Company granted 73,588 PSUs to employees and officers of the Company ( 66,433 to officers of the Company). PSU performance will be measured over three years from January 1, 2024 through December 31, 2026 and will cliff-vest contingent upon the achievement of specified performance objectives. PSUs granted to date vest over a three-year performance period. Additionally, on February 15, 2024, the Company granted 13,054 RSAs to new employees of the Company, which will vest over four years . On February 16, 2024, ANI Pharmaceuticals Canada, Inc. and 1540700 Ontario Limited entered into an agreement of purchase and sale for the Oakville, Ontario manufacturing facility for a purchase price of 19.2 million Canadian Dollars, or approximately $ 14.2 million US Dollars, based on the current exchange rate. The first and second deposits, each amounting to approximately 1.0 million Canadian Dollars or approximately $ 0.7 million US Dollars, based on the current exchange rate, were received on February 20, 2024, and February 27, 2024, respectively. The remaining balance of the purchase price, less deposits, will be paid upon closing, which is expected to occur by the end of March 2024. The closing of the transaction is subject to customary termination conditions, including the buyer’s right to terminate the agreement if the property is materially damaged prior to the closing. On February 22, 2024, the Company paid $ 12.5 million to the Company Members of Novitium for the achievement of the "Gross Profit Earn-Out," as defined in the Novitium acquisition agreement, as discussed in Note 2. On November 15, 2010, ANI, formerly Biosante, entered into an assignment and technology transfer agreement and stock subscription agreement (collectively the "CG Agreement") with CG Oncology, Inc. formerly, Cold Genesys, Inc. (“CG Oncology”), pursuant to which the Company sold to CG Oncology exclusive, worldwide rights to develop and commercialize BioSante’s oncolytic virus technology. The technology includes a replication-competent adenovirus that has completed clinical trials for treatment of superficial bladder cancer. Under the terms of the CG Agreement, the Company receive d an equity investment in CG Oncology, an upfront cash payment and the right to receive future royalty payments. Historically, this equity investment was recorded at cost and as of December 31, 2023, this equity investment was valued at zero . On January 24, 2024, CG Oncology completed their Initial Public Offering, at an offering price of $ 19.00 per share. The Company currently holds 219,925 shares of common stock in CG Oncology. As of February 27, 2024 these shares are valued at approximately $ 10.2 million. On February 28, 2024, CG Oncology disputed the Company's rights to receive royalties. The dispute is unresolved at this time. 115 Table of Contents Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.