Lantheus Holdings, Inc. 10-K

Item 8. Financial Statements and Supplementary Data LANTHEUS HOLDINGS, INC. INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm (PCAOB ID No. 34 ) 77 Consolidated Balance Sheets 79 Consolidated Statements of Operations 80 Consolidated Statements of Comprehensive (Loss) Income 81 Consolidated Statements of Changes in Stockholders’ Equity 82 Consolidated Statements of Cash Flows 83 Notes to Consolidated Financial Statements 85 76 Table of Contents REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Stockholders and the Board of Directors of Lantheus Holdings, Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Lantheus Holdings, Inc. and subsidiaries (the "Company") as of December 31, 2021 and 2020, the related consolidated statements of operations, comprehensive (loss) income, stockholders’ equity, and cash flows, for each of the three years in the period ended December 31, 2021, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2021, in conformity with accounting principles generally accepted in the United States of America. We have also 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, 2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 24, 2022, expressed an unqualified opinion on the Company's internal control over financial reporting. 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) relates 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 matters 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 a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. Valuation of Contingent Value Rights— Refer to Notes 1 and 4 to the financial statements Critical Audit Matter Description As part of the acquisition of Progenics Pharmaceuticals, Inc. (“Progenics”) on June 19, 2020, the Company issued contingent value rights (“CVRs”) to certain stockholders of Progenics entitling them to future cash payments of 40% of U.S. net sales generated by PYLARIFY in 2022 and 2023 in excess of $100.0 million and $150.0 million, respectively. The estimated fair value of the CVRs was determined using a Monte-Carlo simulation model that included estimates and assumptions pertaining to (1) the period of expected milestone achievement and net sales targets and (2) discount rates. The fair value determination of these CVRs therefore required management to make estimates and assumptions related the periods in which net sales targets will be achieved and the selection of the discount rates. We identified the valuation of the contingent consideration liabilities related to the CVRs as a critical audit matter because of the estimates and assumptions used by management to determine the fair value of these CVRs. Auditing the estimates and assumptions related to the valuation of the CVRs required a high degree of auditor judgment and an increased extent of effort, including the involvement of our valuation specialists, when performing audit procedures to evaluate the reasonableness of management’s estimates as to the period of expected milestone achievement and net sales targets and the selection of the discount rates. 77 Table of Contents How the Critical Audit Matter Was Addressed in the Audit Our audit procedures related to the valuation of the CVRs, including assessing the periods in which net sales targets will be achieved and the selection of discount rates included the following, among others: • We agreed the calculation to determine the CVR amounts payable to the terms of the merger agreement. • We tested the effectiveness of controls over the valuation of the CVRs, including management’s controls over the determination of amounts and timing of net sales targets, and the selection of discount rates. • We evaluated the reasonableness of the periods of expected milestone achievement and net sales targets by comparing these assumptions to (1) internal communications to management and the Board of Directors, (2) information obtained from individuals outside of the finance department and (3) information included in the Company’s external communications. • We evaluated management’s ability to accurately estimate the periods in which net sales targets will be achieved and the reasonableness of such estimates by comparing management’s historical net sales estimates to subsequent results of operations, and comparing the forecasts to internal and external data, while also taking into account any changes in market conditions. • We evaluated whether the period of expected milestone achievement and net sales targets were consistent with evidence obtained in other areas of the audit. • With the assistance of our fair value specialists, we evaluated the acceptability of the (1) valuation methodology and calculation and (2) discount rate by: ◦ Evaluating the appropriateness of the valuation methodology and the calculation of the Monte-Carlo simulation model used by the Company. ◦ Testing the source information underlying the determination of the discount rate and testing the mathematical accuracy of the calculation. ◦ Developing a range of independent estimates and comparing those to the discount rate selected by management. /s/ Deloitte & Touche LLP Boston, Massachusetts February 24, 2022 We have served as the Company’s auditor since 2007. 78 Table of Contents Lantheus Holdings, Inc. Consolidated Balance Sheets (in thousands, except par value) December 31, 2021 2020 Assets Current assets Cash and cash equivalents $ 98,508 $ 79,612 Accounts receivable, net 89,336 54,002 Inventory 35,129 35,744 Other current assets 12,818 9,625 Assets held for sale — 5,242 Total current assets 235,791 184,225 Property, plant and equipment, net 116,772 120,171 Intangibles, net 348,510 376,012 Goodwill 61,189 58,632 Deferred tax assets, net 62,764 70,147 Other long-term assets 38,758 60,634 Total assets $ 863,784 $ 869,821 Liabilities and stockholders’ equity Current liabilities Current portion of long-term debt and other borrowings $ 11,642 $ 20,701 Accounts payable 20,787 16,284 Accrued expenses and other liabilities 58,068 41,726 Liabilities held for sale — 1,793 Total current liabilities 90,497 80,504 Asset retirement obligations 20,833 14,020 Long-term debt, net and other borrowings 163,121 197,699 Other long-term liabilities 124,894 63,393 Total liabilities 399,345 355,616 Commitments and contingencies (see Note 20) Stockholders’ equity Preferred stock ($ 0.01 par value, 25,000 shares authorized; no shares issued and outstanding) — — Common stock ($ 0.01 par value, 250,000 shares authorized; 67,739 and 66,875 shares issued and outstanding, respectively) 677 669 Additional paid-in capital 685,472 665,530 Accumulated deficit ( 221,225 ) ( 149,946 ) Accumulated other comprehensive loss ( 485 ) ( 2,048 ) Total stockholders’ equity 464,439 514,205 Total liabilities and stockholders’ equity $ 863,784 $ 869,821 The accompanying notes are an integral part of these consolidated financial statements. 79 Table of Contents Lantheus Holdings, Inc. Consolidated Statements of Operations (in thousands, except per share data) Year Ended December 31, 2021 2020 2019 Revenues $ 425,208 $ 339,410 $ 347,337 Cost of goods sold 237,513 200,649 172,526 Gross profit 187,695 138,761 174,811 Operating expenses Sales and marketing 68,422 40,901 41,888 General and administrative 150,395 69,270 61,244 Research and development 44,966 32,788 20,018 Total operating expenses 263,783 142,959 123,150 Gain on sales of assets 15,263 — — Operating (loss) income ( 60,825 ) ( 4,198 ) 51,661 Interest expense 7,752 9,479 13,617 (Gain) loss on extinguishment of debt ( 889 ) — 3,196 Other loss (income) 7,350 ( 2,198 ) 6,221 (Loss) income before income taxes ( 75,038 ) ( 11,479 ) 28,627 Income tax (benefit) expense ( 3,759 ) 1,994 ( 3,040 ) Net (loss) income $ ( 71,279 ) $ ( 13,473 ) $ 31,667 Net (loss) income per common share: Basic $ ( 1.06 ) $ ( 0.25 ) $ 0.81 Diluted $ ( 1.06 ) $ ( 0.25 ) $ 0.79 Weighted-average common shares outstanding: Basic 67,486 54,134 38,988 Diluted 67,486 54,134 40,113 The accompanying notes are an integral part of these consolidated financial statements. 80 Table of Contents Lantheus Holdings, Inc. Consolidated Statements of Comprehensive (Loss) Income (in thousands) Year Ended December 31, 2021 2020 2019 Net (loss) income $ ( 71,279 ) $ ( 13,473 ) $ 31,667 Other comprehensive income (loss): Foreign currency translation ( 124 ) 330 148 Unrealized gain (loss) on cash flow hedges, net of tax 1,687 ( 1,418 ) — Total other comprehensive income (loss) 1,563 ( 1,088 ) 148 Comprehensive (loss) income $ ( 69,716 ) $ ( 14,561 ) $ 31,815 The accompanying notes are an integral part of these consolidated financial statements. 81 Table of Contents Lantheus Holdings, Inc. Consolidated Statements of Changes in Stockholders’ Equity (in thousands) Common Stock Additional Paid-In Capital Accumulated Deficit Accumulated Other Comprehensive Loss Total Stockholders’ Equity Shares Amount Balance, January 1, 2019 38,466 $ 385 $ 239,865 $ ( 168,140 ) $ ( 1,108 ) $ 71,002 Net income — — — 31,667 — 31,667 Other comprehensive income — — — — 148 148 Stock option exercises and employee stock plan purchases 95 1 1,745 — — 1,746 Vesting of restricted stock awards 796 8 ( 8 ) — — — Shares withheld to cover taxes ( 106 ) ( 1 ) ( 2,453 ) — — ( 2,454 ) Stock-based compensation — — 12,492 — — 12,492 Balance, December 31, 2019 39,251 393 251,641 ( 136,473 ) ( 960 ) 114,601 Net loss — — — ( 13,473 ) — ( 13,473 ) Other comprehensive loss — — — — ( 1,088 ) ( 1,088 ) Stock option exercises and employee stock plan purchases 73 1 759 — — 760 Vesting of restricted stock awards 847 8 ( 8 ) — — — Shares withheld to cover taxes ( 141 ) ( 2 ) ( 2,127 ) — — ( 2,129 ) Issuance of common stock, net of $ 3,776 issuance costs 26,845 269 394,065 — — 394,334 Fair value of replacement stock options related to precombination services — — 7,125 — — 7,125 Stock-based compensation — — 14,075 — — 14,075 Balance, December 31, 2020 66,875 669 665,530 ( 149,946 ) ( 2,048 ) 514,205 Net loss — — — ( 71,279 ) — ( 71,279 ) Other comprehensive income — — — — 1,563 1,563 Stock option exercises and employee stock plan purchases 360 3 6,059 — — 6,062 Vesting of restricted stock awards and units 611 6 ( 6 ) — — — Shares withheld to cover taxes ( 107 ) ( 1 ) ( 2,045 ) — — ( 2,046 ) Stock-based compensation — — 15,934 — — 15,934 Balance, December 31, 2021 67,739 $ 677 $ 685,472 $ ( 221,225 ) $ ( 485 ) $ 464,439 The accompanying notes are an integral part of these consolidated financial statements. 82 Table of Contents Lantheus Holdings, Inc. Consolidated Statements of Cash Flows (in thousands) Year Ended December 31, 2021 2020 2019 Operating activities Net (loss) income $ ( 71,279 ) $ ( 13,473 ) $ 31,667 Adjustments to reconcile net (loss) income to net cash flows from operating activities: Depreciation, amortization and accretion 42,288 24,689 13,379 Impairment of long-lived assets 9,729 9,935 — ARO acceleration 5,259 — — Amortization of debt related costs 676 119 978 Changes in fair value of contingent assets and liabilities 72,400 ( 2,000 ) — (Gain) loss on extinguishment of debt ( 889 ) — 3,196 Provision for excess and obsolete inventory 4,057 2,365 1,851 Stock-based compensation 15,934 14,075 12,492 (Gain) loss on disposal of assets ( 15,263 ) 2,250 286 Deferred taxes 4,437 ( 1,334 ) 9,725 Long-term indemnification receivable 7,121 ( 2,218 ) 10,635 Long-term income tax payable and other long-term liabilities ( 7,912 ) 2,828 ( 13,156 ) Other 2,512 1,525 282 Increases (decreases) in cash from operating assets and liabilities: Accounts receivable ( 33,102 ) ( 7,462 ) 156 Inventory ( 3,549 ) ( 8,459 ) 1,994 Other current assets ( 73 ) 1,941 ( 2,411 ) Accounts payable 5,425 ( 4,224 ) 3,233 Accrued expenses and other liabilities 16,145 ( 4,161 ) 6,077 Net cash provided by operating activities 53,916 16,396 80,384 Investing activities Capital expenditures ( 12,140 ) ( 12,474 ) ( 22,061 ) Proceeds from sale of assets, net 15,823 — — Lending on bridge loan — ( 10,000 ) — Cash acquired in acquisition of business — 17,562 — Net cash provided by (used in) investing activities 3,683 ( 4,912 ) ( 22,061 ) Financing activities Proceeds from issuance of common stock 767 683 573 Equity issuance costs — ( 3,777 ) — Proceeds from issuance of long-term debt — — 199,461 Payments on long-term debt and other borrowings ( 43,348 ) ( 15,491 ) ( 275,376 ) Deferred financing costs — ( 1,224 ) ( 2,258 ) Proceeds from stock option exercises 5,295 77 1,173 Payments for minimum statutory tax withholding related to net share settlement of equity awards ( 2,046 ) ( 2,129 ) ( 2,454 ) Net cash used in financing activities ( 39,332 ) ( 21,861 ) ( 78,881 ) Effect of foreign exchange rates on cash and cash equivalents ( 310 ) 152 76 Net increase (decrease) in cash and cash equivalents and restricted cash 17,957 ( 10,225 ) ( 20,482 ) Cash and cash equivalents and restricted cash, beginning of year 82,694 92,919 113,401 Cash and cash equivalents and restricted cash, end of year $ 100,651 $ 82,694 $ 92,919 83 Table of Contents Lantheus Holdings, Inc. Consolidated Statements of Cash Flows (Continued) (in thousands) Year Ended December 31, 2021 2020 2019 Reconciliation to amounts within the consolidated balance sheets Cash and cash equivalents $ 98,508 $ 79,612 $ 92,919 Cash and cash equivalents included in assets held for sale — 941 — Restricted cash included in other long-term assets 2,143 2,141 — Cash, cash equivalents and restricted cash at end of period $ 100,651 $ 82,694 $ 92,919 Year Ended December 31, 2021 2020 2019 Supplemental disclosure of cash flow information Cash paid during the period for: Interest $ 6,284 $ 9,368 $ 12,253 Income taxes, net of refunds of $ 315 , $ 331 and $ 2 , respectively $ 215 $ 340 $ 274 Schedule of non-cash investing and financing activities Additions of property, plant and equipment included in liabilities $ 1,262 $ 2,227 $ 4,175 Consideration transferred in acquisition $ — $ 419,009 $ — The accompanying notes are an integral part of these consolidated financial statements. 84 Table of Contents Lantheus Holdings, Inc. Notes to Consolidated Financial Statements 1. Description of Business Lantheus Holdings, Inc., a Delaware corporation, is the parent company of Lantheus Medical Imaging, Inc. (“LMI”) and Progenics Pharmaceuticals, Inc., a Delaware corporation (“Progenics”). See “Progenics Acquisition”. The Company develops, manufactures and commercializes innovative diagnostic and therapeutic products that assist clinicians in the diagnosis and treatment of heart disease, cancer and other diseases. The Company believes its diagnostic products result in improved diagnostic information that enables healthcare providers to better detect and characterize, or rule out, disease, potentially achieving improved patient outcomes, reducing patient risk and limiting overall costs for payors and throughout the healthcare system. The Company’s commercial products are used by cardiologists, internal medicine physicians, nuclear medicine physicians, oncologists, radiologists, sonographers, technologists and urologists working in a variety of clinical settings. The Company produces and markets its products throughout the U.S., selling primarily to clinics, group practices, hospitals, integrated delivery networks and radiopharmacies. The Company sells its products outside the U.S. through a combination of direct distribution in Canada and third party distribution relationships in Europe, Canada, Australia, Asia-Pacific, Central America and South America. Sales of the Company’s microbubble ultrasound enhancing agent, DEFINITY, are generated in the U.S. and Canada through a DEFINITY direct sales team. Sales of the Company’s prostate cancer diagnostic imaging agent, PYLARIFY (as defined below), are generated in the U.S. through a PYLARIFY direct sales team and a sales team at some of our positron emission tomography (“PET”) manufacturing facilities (“PMF”) partners. In the U.S., the Company’s other nuclear imaging products, including TechneLite, Xenon, NEUROLITE and Cardiolite, are primarily sold to commercial radiopharmacies, the majority of which are controlled by or associated with GE Healthcare, Cardinal, UPPI, Jubilant Radiopharma and PharmaLogic. A small portion of the Company’s nuclear imaging product sales in the U.S. are generated through the Company’s direct sales force to hospitals and clinics that maintain their own in-house radiopharmaceutical preparation capabilities. AZEDRA sales are generated in the U.S. through an AZEDRA direct sales team. We have licensed RELISTOR to Bausch, and the Company collects quarterly royalties based on those sales. The Company also maintains its own direct sales force in Canada for certain of its products. In Europe, Australia, Asia-Pacific, Central America and South America, the Company generally relies on third party distributors to market, sell and distribute its nuclear imaging and ultrasound enhancing agent products, either on a country-by-country basis or on a multi-country regional basis. The Company’s headquarters are located in North Billerica, MA, with additional offices in Somerset, NJ, Montreal, Canada and Lund, Sweden. Progenics Acquisition On June 19, 2020 (the “Closing Date”), pursuant to the Amended and Restated Agreement and Plan of Merger, dated as of February 20, 2020 (the “Merger Agreement”), by and among Holdings, Plato Merger Sub, Inc., a wholly-owned subsidiary of Holdings (“Merger Sub”), and Progenics, Holdings completed the acquisition of Progenics by means of a merger of Merger Sub with and into Progenics, with Progenics surviving such merger as a wholly-owned subsidiary of Holdings (the “Progenics Acquisition”). In accordance with the Merger Agreement, at the effective time of the Progenics Acquisition (the “Effective Time”), each share of Progenics common stock, par value $ 0.0013 per share, issued and outstanding immediately prior to the Effective Time (other than shares of Progenics common stock owned by Holdings, Progenics or any of their wholly-owned subsidiaries) was automatically cancelled and converted into the right to receive (i) 0.31 (the “Exchange Ratio”) of a share of Holdings common stock, par value $ 0.01 per share, and (ii) one contingent value right (a “CVR”) tied to the financial performance of PyL (18F-DCFPyL), Progenics’ prostate-specific membrane antigen (“PSMA”) targeted imaging agent designed to visualize prostate cancer. This agent was approved by the U.S. Food and Drug Administration (“FDA”) on May 26, 2021 under the name PYLARIFY (piflufolastat F 18), and the commercial launch of this agent has begun. Each CVR will entitle its holder to receive a pro rata share of aggregate cash payments equal to 40 % of U.S. net sales generated by PYLARIFY in 2022 and 2023 in excess of $ 100.0 million and $ 150.0 million, respectively. In no event will the Company’s aggregate payments in respect of the CVRs, together with any other non-stock consideration treated as paid in connection with the Progenics Acquisition, exceed 19.9 % of the total consideration the Company pays in the Progenics Acquisition (which the Company currently estimates could be approximately $ 100.0 million). The Company will issue the aforementioned cash payments related to the CVRs during the first quarter of 2023 and the first quarter of 2024 respectively. No fractional shares of Holdings common stock were issued in the Progenics Acquisition, and Progenics’ former stockholders have received cash in lieu of any fractional shares of Holdings common stock. In addition, in accordance with the Merger Agreement, at the Effective Time, each Progenics stock option with a per share exercise price less than or equal to $ 4.42 (an “in-the-money Progenics stock option”) received in exchange for each such in-the money Progenics stock option: (i) an option to purchase Holdings common stock (each, a 85 Table of Contents “Replacement Stock Option”) converted based on the Exchange Ratio, and (ii) a vested or unvested CVR depending on whether the underlying in-the-money Progenics stock option was vested at the Effective Time. Each Progenics stock option with a per share exercise price greater than $ 4.42 (an “out-of-the-money Progenics stock option”) received in exchange for such out-of-the-money Progenics stock options a Replacement Stock Option converted at an exchange ratio determined based on the average of the volume weighted average price per share of common stock of Progenics and Lantheus Holdings prior to the Effective Time, which exchange ratio was 0.31 , the same as the Exchange Ratio. As a result of the acquisition, Holdings issued 26,844,877 shares of Holdings common stock and 86,630,633 CVRs to former Progenics stockholders. Please refer to Note 8, “Business Combinations”, for further details on the acquisition. PYLARIFY Approval and Commercial Launch On May 27, 2021, the Company announced that the FDA had approved PYLARIFY, a fluorine-18- (“F 18”) labeled PET imaging agent targeting prostate-specific membrane antigen (“PSMA”). PYLARIFY is a radioactive diagnostic agent indicated for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and with suspected recurrence based on elevated serum prostate-specific antigen (“PSA”) levels. PYLARIFY is a product in the Company’s radiopharmaceutical oncology product category. The Company commenced its commercial launch of PYLARIFY in the U.S. in June 2021. Upon commercial launch in June 2021, PYLARIFY was immediately available in select parts of the U.S. Over the course of the remainder of 2021, PYLARIFY availability expanded into additional regions and is now broadly available nationwide. The Company continues to expand its geographic coverage, customer contracting and market access coverage to serve its customers and the U.S. prostate cancer community. The commercial launch of PYLARIFY is complex and expensive. During 2021, the Company hired additional employees to assist it with the commercialization of PYLARIFY, including in sales, marketing, reimbursement, quality and medical affairs. To manufacture PYLARIFY, the Company assembled and qualified a nationwide network of PMFs with radioisotope-producing cyclotrons that make F 18, which has a 110-minute half-life, so PYLARIFY is manufactured and distributed rapidly to end-users. After being made on a cyclotron at a PMF, the F 18 is then combined with certain chemical ingredients in specially designed chemistry synthesis boxes to manufacture PYLARIFY. The finished PYLARIFY is then quality control tested and transferred to a radiopharmacist who prepares and dispenses patient-specific doses of the final product. Because each of the PMFs manufacturing these products is deemed by the FDA to be a separate manufacturing site, each has to be approved by the FDA. Although PYLARIFY is now broadly available nationwide, the Company can give no assurance that the FDA will continue to approve PMFs in accordance with the Company’s planned roll-out schedule. If FDA approval of manufacturing sites is delayed or withdrawn, the Company’s future business, results of operations, financial condition and cash flows could be adversely affected. The Company’s commercial launch also required the Company to obtain adequate coding and coverage for PYLARIFY, including not only coverage from Medicare, Medicaid and other government payors, as well as private payors, but also appropriate payment levels, which adequately cover our customers’ costs of using PYLARIFY in PET/CT imaging procedures. We received notification that our HCPCS code, which enables streamlined billing, went into effect as of January 1, 2022. In addition, effective January 1, 2022, CMS granted Transitional Pass-Through Payment Status in the hospital outpatient setting (“TPT Status”) for PYLARIFY, enabling traditional Medicare to provide an incremental payment for PET/CT scans performed with PYLARIFY in this setting. TPT Status for PYLARIFY is expected to expire December 31, 2024. After TPT Status expires, under current Medicare rules, PYLARIFY, similar to other diagnostic radiopharmaceuticals, would not be separately reimbursed in the hospital outpatient setting but rather would be included as part of the facility fee a hospital otherwise receives for a PET/CT imaging procedure, and the facility fee does not always cover the cost of a drug used in the procedure. The Company can give no assurance that any CMS reimbursement in the hospital outpatient setting that follows the expiration of TPT Status will be adequate to cover the cost of PYLARIFY used in a PET/CT imaging procedure. COVID-19 Pandemic The Company experienced operational and financial impacts from the COVID-19 pandemic beginning late in the first quarter of 2020 and through the date of this filing, including the impact of hospital staffing challenges, vaccination mandates, employee absences due to illness, and a decline in the volume of certain procedures and treatments using the Company’s products. For example, we believe that during the fourth quarter of 2021 sales of DEFINITY were impacted by hospital nursing and sonographer shortages, and sales of AZEDRA were impacted by treatment capacity constraints in hospitals, treatment deferrals and cancellations by patients, and access restrictions by hospitals. There has also been a substantial reduction in pulmonary ventilation studies in which the Company’s product, Xenon, is used. As a result of the COVID-19 pandemic, the Company undertook a thorough analysis of all its discretionary expenses. In the first quarter of 2020, the Company implemented certain cost reduction initiatives. For most of the second quarter of 2020, the Company reduced the Company’s work week from five days to four days and reduced the pay for employees by varying amounts depending on level of seniority. 86 Table of Contents During the second quarter of 2020, Progenics also implemented certain cost reduction initiatives and paused new enrollment in the ARROW Phase 2 study of 1095, a PSMA-targeted therapeutic, in metastatic castrate-resistant prostate cancer (“mCRPC”) patients to minimize the risk to subjects and healthcare providers during the pandemic. New enrollment in that study restarted in October 2020. GE Healthcare Limited (“GE Healthcare”), the Company’s development and commercialization partner for flurpiridaz fluorine-18 F 18, also delayed enrollment in the second Phase 3 clinical trial of flurpiridaz F 18 because of the pandemic and resumed enrollment in the third quarter of 2020. Although some of the restrictions, including stay-at-home mandates, imposed in response to the COVID-19 pandemic have been lifted in much of the United States (the “U.S.”), and there has been a rapid rollout and development of multiple vaccines and boosters, the resurgence of COVID-19 infections continued to impact certain aspects of the Company’s business during 2021 and the pandemic could still have a future negative impact on the Company's business, particularly if there are additional resurgences as a result of mutations or other variations to the virus that increase its communicability or its impact on certain populations, geographic regions and the healthcare system, including elective procedures and hospital access. 2. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with U.S. GAAP. The consolidated financial statements include the accounts of the Company and its direct and indirect wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. The more significant estimates reflected in the Company’s consolidated financial statements include, but are not limited to, certain judgments regarding revenue recognition, goodwill, tangible and intangible asset valuation, inventory valuation, asset retirement obligations, contingent assets and liabilities, income tax liabilities and related indemnification receivable, deferred tax assets and liabilities and accrued expenses. Actual results could materially differ from those estimates or assumptions. Revenue Recognition The Company recognizes revenue when it transfers control of promised goods or services to its customers in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for those goods and services. See Note 3, “Revenue from Contracts with Customers” for further discussion on revenues. Accounts Receivable, net Accounts receivable consist of amounts billed and currently due from customers. The Company maintains an allowance for doubtful accounts for estimated losses. In determining the allowance, consideration includes the probability of recoverability based on past experience and general economic factors. Certain accounts receivable may be fully reserved when the Company becomes aware of any specific collection issues. The Company periodically reviews the aging of receivables, payment history and customer creditworthiness to determine if adjustments to the allowance for bad debt is necessary. Allowance for bad debt has been immaterial for all years presented. Income Taxes The Company accounts for income taxes using an asset and liability approach. Income tax expense (benefit) represents income taxes paid or payable for the current year plus the change in deferred taxes during the year. Deferred taxes result from differences between the financial and tax bases of the Company’s assets and liabilities. Deferred tax assets and liabilities are measured using the currently enacted tax rates that apply to taxable income in effect for the years in which those tax attributes are expected to be recovered or paid, and are adjusted for changes in tax rates and tax laws when such changes are enacted. The Company recognizes deferred tax assets to the extent that the Company believes that these assets are more-likely-than-not to be realized. Valuation allowances are recorded to reduce deferred tax assets when it is more-likely-than-not that the future tax benefit will not be realized. The assessment of whether or not a valuation allowance is required involves weighing both positive and negative evidence, including both historical and prospective information, with greater weight given to evidence that is objectively verifiable. A history of recent losses is negative evidence that is difficult to overcome with positive evidence. In evaluating prospective information there are four sources of taxable income: reversals of taxable temporary differences, items that can be carried back to prior tax years (such as net operating losses), pre-tax income, and prudent and feasible tax planning strategies. Adjustments to the deferred tax valuation allowances are made in the period when those assessments are made. 87 Table of Contents The Company accounts for uncertain tax positions using a two-step recognition threshold and measurement analysis method to determine the financial statement impact of uncertain tax positions taken or expected to be taken in a tax return. Differences between tax positions taken in a tax return and amounts recognized in the financial statements are recorded as adjustments to other long-term assets and liabilities, or adjustments to deferred taxes, or both. The Company records the related interest and penalties to income tax (benefit) expense. Net Income (Loss) per Common Share Basic earnings per common share is computed by dividing net income by the weighted-average number of shares of common stock outstanding during the period. Diluted earnings per common share is computed by dividing net income by the weighted-average number of shares of common stock outstanding during the period, plus the potential dilutive effect of other securities as if those securities were converted or exercised. During periods in which the Company incurs net losses, both basic and diluted loss per common share is calculated by dividing the net loss by the weighted-average shares of common stock outstanding and potentially dilutive securities are excluded from the calculation because their effect would be antidilutive. Cash and Cash Equivalents Cash and cash equivalents include savings deposits, certificates of deposit and money market funds that have original maturities of three months or less when purchased. Restricted Cash Restricted cash as of December 31, 2021 and 2020, represents primarily collateral for a letter of credit securing a lease obligation and a security deposit. The Company believes the carrying value of these assets approximates fair value. Concentration of Risks and Limited Suppliers Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of trade accounts receivable. The Company periodically reviews its accounts receivable for collectability and provides for an allowance for doubtful accounts to the extent that amounts are not expected to be collected. The Company sells primarily to clinics, distributors, group practices, hospitals, integrated delivery networks and radiopharmacies. As of December 31, 2021 and 2020, no customer accounted for greater than 10% of accounts receivable, net. No customer accounted for greater than 10% of revenues for the years ended December 31, 2021, 2020 and 2019. The Company relies on certain materials used in its development and manufacturing processes, some of which are procured from only one or a few sources. The failure of one of these suppliers to deliver on schedule could delay or interrupt the manufacturing or commercialization process and would adversely affect the Company’s operating results. In addition, a disruption in the commercial supply of, or a significant increase in the cost of one of the Company’s materials from these sources could have a material adverse effect on the Company’s business, financial position and results of operations. The Company has Mo-99 supply agreements with IRE of Belgium, running through December 31, 2022, with auto-renewal provisions and terminable upon notice of non-renewal, and with NTP and its subcontractor ANSTO, running through March 31, 2022, and for which the Company is currently negotiating an extension. The Company also has a Xenon supply agreement with IRE which runs through December 31, 2023, with auto-renewal provisions and terminable upon notice of non-renewal. The Company currently relies on IRE as the sole supplier of bulk-unprocessed Xenon which the Company processes and finishes for its customers. The Company currently relies on JHS as its significant manufacturer of DEFINITY and its sole source manufacturer of NEUROLITE, Cardiolite and evacuation vials for TechneLite. The following table sets forth revenues for each of the Company’s products representing 10% or more of revenues: Year Ended December 31, 2021 2020 2019 DEFINITY 54.7 % 62.8 % 62.6 % TechneLite 21.5 % 25.4 % 24.9 % PYLARIFY 10.2 % — % — % Inventory Inventory includes material, direct labor and related manufacturing overhead and is stated at the lower of cost and net realizable value on a first-in, first-out basis. The Company records inventory when the Company takes title to the product. 88 Table of Contents The Company assesses the recoverability of inventory to determine whether adjustments for excess and obsolete inventory are required. Inventory that is in excess of future requirements is written down to its estimated net realizable value based on product shelf life, forecasted demand and other factors. Inventory costs associated with product that has not yet received regulatory approval are capitalized if the Company believes there is probable future commercial use of the product and future economic benefits of the asset. If future commercial use of the product is not probable, then inventory costs associated with such product are expensed as incurred. As of December 31, 2021 and 2020, the Company had $ 6.1 million and no capitalized inventories associated with product that did not have regulatory approval, respectively. Property, Plant and Equipment, net Property, plant & equipment are stated at cost. Replacements of major units of property are capitalized, and replaced properties are retired. Replacements of minor components of property and repair and maintenance costs are charged to expense as incurred. Certain costs to obtain or develop computer software are capitalized and amortized over the estimated useful life of the software. Depreciation and amortization is computed on a straight-line basis over the estimated useful lives of the related assets and recorded throughout costs of goods sold and operating expenses in the associated functional expense category which utilizes the associated asset. The estimated useful lives of the major classes of depreciable assets are as follows: Class Range of Estimated Useful Lives Buildings 10 - 50 years Land improvements 15 - 40 years Machinery and equipment 3 - 15 years Furniture and fixtures 15 years Leasehold improvements Lesser of lease term or 15 years Computer software 3 - 5 years Upon retirement or other disposal of property, plant & equipment, the cost and related amount of accumulated depreciation are removed from the asset and accumulated depreciation accounts, respectively. The difference, if any, between the net asset value and the proceeds is included in operating income. Included within machinery, equipment and fixtures are spare parts. Spare parts include replacement parts relating to plant & equipment and are either recognized as an expense when consumed or reclassified and capitalized as part of the related asset and depreciated over the remaining useful life of the related asset. Business Combinations The Company accounts for business combinations using the acquisition method of accounting. The Company recognizes the assets acquired and liabilities assumed in business combinations on the basis of their fair values at the date of acquisition. The Company assesses the fair value of assets acquired, including intangible assets, and liabilities assumed using a variety of methods. Each asset acquired and liability assumed is measured at fair value from the perspective of a market participant. The method used to estimate the fair values of intangible assets incorporates significant assumptions regarding the estimates a market participant would make in order to evaluate an asset, including a market participant’s use of the asset and the appropriate discount rates. Acquired IPR&D is recognized at fair value and initially characterized as an indefinite-lived intangible asset, irrespective of whether the acquired IPR&D has an alternative future use. Any excess purchase price over the fair value of the net tangible and intangible assets acquired is allocated to goodwill. Transaction costs and restructuring costs associated with a business combination are expensed as incurred. During the measurement period, which extends no later than one year from the acquisition date, the Company may record certain adjustments to the carrying value of the assets acquired and liabilities assumed with the corresponding offset to goodwill. After the measurement period, all adjustments are recorded in the consolidated statements of operations as operating expenses or income. The Company recorded a measurement period adjustment of $ 2.6 million related to deferred taxes for the three months ended March 31, 2021, which finalized all measurement period adjustments related to the Progenics Acquisition. 89 Table of Contents Goodwill Goodwill is not amortized but is instead tested for impairment at least annually and whenever events or circumstances indicate that it is more likely-than-not that they may be impaired. The Company has elected to perform the annual test for goodwill impairment as of October 31 of each year. In performing the Company’s annual assessment, the Company is permitted to first perform a qualitative test and if necessary, perform a quantitative test. If the Company is required to perform the quantitative impairment test of goodwill, the Company compares the fair value of a reporting unit to its carrying value. If the reporting unit’s carrying value exceeds its fair value, the Company would record an impairment loss to the extent that the carrying value of goodwill exceeds its implied fair value. The Company estimates the fair value of its reporting units using discounted cash flow or other valuation models, such as comparative transactions and market multiples. The Company did no t recognize any goodwill impairment charges during the years ended December 31, 2021, 2020 or 2019. Intangible and Long-Lived Assets The Company tests intangible and long-lived assets for recoverability whenever events or changes in circumstances suggest that the carrying value of an asset or group of assets may not be recoverable. The Company measures the recoverability of assets to be held and used by comparing the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset. If those assets are considered to be impaired, the impairment equals the amount by which the carrying amount of the assets exceeds the fair value of the assets. Any impairments are recorded as permanent reductions in the carrying amount of the assets. See Note 7, “Property, Plant and Equipment, Net” for further details on impairment. Long-lived assets, other than goodwill and other intangible assets that are held for sale are recorded at the lower of the carrying value or the fair market value less the estimated cost to sell. Intangible assets, consisting of patents, trademarks, customer relationships, a currently marketed product, licenses and developed technology related to the Company’s products are amortized in a method equivalent to the estimated utilization of the economic benefit of the asset. The Company’s in-process research and development (“IPR&D”) represents intangible assets acquired in a business combination that are used in research and development activities but have not yet reached technological feasibility, regardless of whether they have alternative future use. The primary basis for determining the technological feasibility or completion of these projects is obtaining regulatory approval to market the underlying products in an applicable geographic region. Because obtaining regulatory approval can include significant risks and uncertainties, the eventual realized value of the acquired IPR&D projects may vary from their fair value at the date of acquisition. The Company classifies IPR&D acquired in a business combination as an indefinite-lived intangible asset until the completion or abandonment of the associated research and development efforts. Upon completion of the associated research and development efforts, the Company will determine the useful life and begin amortizing the assets to reflect their use over their remaining lives. Upon permanent abandonment, the Company writes-off the remaining carrying amount of the associated IPR&D intangible asset. IPR&D assets are tested at least annually as of October 31 or when a triggering event occurs that could indicate a potential impairment and any impairment loss is recognized in the Company’s consolidated statements of operations. See Note 11, “Intangibles, net and Goodwill” for further details on impairment. Contingencies In the normal course of business, the Company is subject to loss contingencies, such as legal proceedings and claims arising out of its business, that cover a wide range of matters, including, among others, product and environmental liability. The Company records accruals for those loss contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. The Company does not recognize gain contingencies until realized. Fair Values of Financial Instruments The estimated fair values of the Company’s financial instruments, including its cash and cash equivalents, accounts receivable, accounts payable and accrued expenses approximate the carrying values of these instruments due to their short term nature. The estimated fair value of the Company’s long term debt approximates its carrying values as the applicable interest rates are subject to change with market interest rates. The estimated fair value of the Company’s royalty-backed long-term debt approximates its carrying value as the interest rate is in line with the market interest rates for this type of debt with the respective underlining collateral value. See Note 4, “Fair Value of Financial Instruments”. Contingent Consideration Liabilities The estimated fair value of contingent consideration liabilities, initially measured and recorded on the acquisition date, are considered to be a Level 3 instrument and are reviewed quarterly, or whenever events or circumstances occur that indicate a change in 90 Table of Contents fair value. The contingent consideration liabilities are recorded at fair value at the end of each reporting period with changes in estimated fair values recorded in general and administrative expenses in the consolidated statements of operations. The estimated fair value is determined based on probability adjusted discounted cash flows and Monte Carlo simulation models that include significant estimates and assumptions pertaining to commercialization events and sales targets. The most significant unobservable inputs are the probabilities of achieving regulatory approval of the development projects and subsequent commercial success. Significant changes in any of the probabilities of success would result in a significantly higher or lower fair value measurement. Significant changes in the probabilities as to the periods in which milestones will be achieved would result in a significantly lower or higher fair value measurement. Derivative Instruments The Company uses interest rate swaps to reduce the variability in cash flows associated with a portion of the Company’s forecasted interest payments on its variable rate debt. To qualify for hedge accounting, the hedging instrument must be highly effective at reducing the risk from the exposure being hedged. Further, the Company must formally document the hedging relationship at inception and, on at least a quarterly basis, continually reevaluate the relationship to ensure it remains highly effective throughout the life of the hedge. The Company does not enter into derivative financial instruments for speculative or trading purposes. Advertising and Promotion Costs Advertising and promotion costs are expensed as incurred. During the years ended December 31, 2021, 2020 and 2019, the Company incurred $ 17.5 million, $ 5.2 million and $ 3.8 million, respectively in advertising and promotion costs, which are included in sales and marketing in the consolidated statements of operations. Research and Development Research and development costs are expensed as incurred and relate primarily to the development of new products to add to the Company’s portfolio and costs related to its medical affairs and medical information functions. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and recognized as an expense as the goods are delivered or the related services are performed. Foreign Currency The consolidated statements of operations of the Company’s foreign subsidiaries are translated into U.S. Dollars using weighted-average exchange rates. The net assets of the Company’s foreign subsidiaries are translated into U.S. Dollars using the end of period exchange rates. The impact from translating the net assets of these subsidiaries at changing rates are recorded in the foreign currency translation adjustment account, which is included in accumulated other comprehensive loss in the consolidated balance sheets. Remeasurement of the Company’s foreign currency denominated transactions are included in net income. Transaction gains and losses are reported as a component of other (income) loss in the consolidated statements of operations. Stock-Based Compensation The Company’s stock-based compensation cost is measured at the grant date of the stock-based award based on the fair value of the award and is recognized as expense over the requisite service period, which generally represents the vesting period, and includes an estimate of the awards that will be forfeited. The Company estimates the fair value of each stock-based award on its measurement date using either the current market price of the stock, the Black-Scholes option valuation model or the Monte Carlo simulation valuation model, whichever is most appropriate. The Black-Scholes and Monte Carlo simulation valuation models incorporate assumptions such as stock price volatility, the expected life of options or awards, a risk-free interest rate and dividend yield. Expected volatility is based on the historical volatility of the Company’s stock price. The risk-free interest rates are based on quoted U.S. Treasury rates for securities with maturities approximating the awards’ expected lives. Expected lives are principally based on the Company’s historical exercise experience with previously issued awards. The expected dividend yield is zero as the Company has never paid dividends and does not currently anticipate paying any in the foreseeable future. Expense for performance restricted stock awards is recognized based upon the fair value of the awards on the date of grant and the number of shares expected to vest based on the terms of the underlying award agreement and the requisite service period(s). 91 Table of Contents Other Loss (Income) Other loss (income) consisted of the following: Year Ended December 31, (in thousands) 2021 2020 2019 Foreign currency losses (gains) $ 274 $ 260 $ ( 33 ) Tax indemnification expense (income), net 7,121 ( 2,218 ) 10,635 Interest income ( 45 ) ( 238 ) ( 686 ) Arbitration award — — ( 3,453 ) Other — ( 2 ) ( 242 ) Total other loss (income) $ 7,350 $ ( 2,198 ) $ 6,221 Comprehensive (Loss) Income Comprehensive (loss) income consists of net (loss) income and other gains and losses affecting stockholders’ equity that, under U.S. GAAP, are excluded from net income. For the Company, other comprehensive (loss) income consists of foreign currency translation gains and losses as well as unrealized gains and losses on cash flow hedges related to the Company’s interest rate swaps. The accumulated other comprehensive loss balance consists entirely of foreign currency translation gains and losses and unrealized gains and losses on cash flow hedges related to the Company’s interest rate swaps. Asset Retirement Obligations The Company’s compliance with federal, state, local and foreign environmental laws and regulations may require it to remove or mitigate the effects of the disposal or release of chemical substances in jurisdictions where it does business or maintains properties. The Company establishes accruals when those costs are legally obligated and can be reasonably estimated. Accrual amounts are estimated, which may include the assistance of third party environmental specialists, and are based on currently available information, regulatory requirements, remediation strategies, historical experience, the relative shares of the total remediation costs, a relevant discount rate, and the time periods of when estimated costs can be reasonably predicted. Changes in these assumptions could impact the Company’s future reported results. The Company has production facilities which manufacture and process radioactive materials at its North Billerica, Massachusetts site. The Company considers its legal obligation to remediate its facilities upon a decommissioning of its radioactive-related operations as an asset retirement obligation. The fair value of a liability for asset retirement obligations is recognized in the period in which the liability is incurred. The liability is measured at the present value of the obligation expected to be incurred and is adjusted in subsequent periods as accretion expense is recorded. The corresponding asset retirement costs are capitalized as part of the carrying values of the related long-lived assets and depreciated over the assets’ useful lives. The Company has identified conditional asset retirement obligations related to the future removal and disposal of asbestos contained in certain of the buildings located on the Company’s North Billerica, Massachusetts campus. The Company believes the asbestos is appropriately contained and it is compliant with all applicable environmental regulations. If these properties undergo major renovations or are demolished, certain environmental regulations are in place, which specify the manner in which asbestos must be handled and disposed. The Company is required to record the fair value of these conditional liabilities if they can be reasonably estimated. As of December 31, 2021 and 2020, sufficient information was not available to estimate a liability for such conditional asset retirement obligations as the obligations to remove the asbestos from these properties have indeterminable settlement dates. As such, no liability for conditional asset retirement obligations has been recorded in the accompanying consolidated balance sheets as of December 31, 2021 and 2020. Self-Insurance Reserves The Company’s consolidated balance sheets at December 31, 2021 and 2020 include $ 0.7 million and $ 0.6 million of accrued liabilities associated with employee medical costs that are retained by the Company, respectively. The Company estimates the required liability of those claims on an undiscounted basis based upon various assumptions which include, but are not limited to, the Company’s historical loss experience and projected loss development factors. The required liability is also subject to adjustment in the future based upon changes in claims experience, including changes in the number of incidents (frequency) and change in the ultimate cost per incident (severity). 92 Table of Contents Recent Accounting Pronouncements Standard Description Effective Date for Company Effect on the Consolidated Financial Statements Accounting Standards Adopted During the Year Ended December 31, 2021 ASU 2020-06, “Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40)” This ASU provides guidance to simplify the complexity associated with accounting for convertible instruments and derivatives. For convertible instruments, the number of major separation models required were reduced. Consequently, more convertible debt instruments will be reported as a single liability instrument with no separate accounting for embedded conversion features. This ASU further amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions. The ASU simplifies the diluted net income per share calculation in certain areas as well. January 1, 2021 The adoption of this standard did not have a material impact on the Company’s consolidated financial statements. 93 Table of Contents 3. Revenue from Contracts with Customers Revenue Recognition Revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for these goods or services. To achieve this core principle, the Company applies the following five steps: (1) identify the contracts with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the Company satisfies a performance obligation. Disaggregation of Revenue The following table summarizes revenue by revenue source as follows: Year Ended December 31, Major Products/Service Lines (in thousands) 2021 2020 2019 Product revenue, net (1) $ 400,356 $ 327,695 $ 345,276 License and royalty revenues 24,852 11,715 2,061 Total revenues $ 425,208 $ 339,410 $ 347,337 ______________________________ (1) The Company’s principal products include DEFINITY, TechneLite and PYLARIFY and are categorized within product revenue, net. The Company applies the same revenue recognition policies and judgments for all of its principal products. The Company classifies its revenues into three product categories: precision diagnostics, radiopharmaceutical oncology, and strategic partnerships and other revenue. Precision diagnostics includes DEFINITY, TechneLite and other imaging diagnostic products. Radiopharmaceutical oncology consists primarily of PYLARIFY and AZEDRA. Strategic partnerships and other revenue includes strategic partnerships and other arrangements related to other products of the Company, including RELISTOR. Revenue by product category on a net basis is as follows: Year Ended December 31, (in thousands) 2021 2020 (1) 2019 (1) DEFINITY $ 232,759 $ 195,865 $ 202,398 TechneLite 91,293 84,945 85,465 Other precision diagnostics 26,973 36,824 49,243 Total precision diagnostics 351,025 317,634 337,106 PYLARIFY 43,414 — — Other radiopharmaceutical oncology 5,473 10,022 8,655 Total radiopharmaceutical oncology 48,887 10,022 8,655 Strategic Partnerships and other revenue 25,296 11,754 1,576 Total revenues $ 425,208 $ 339,410 $ 347,337 ________________________________ (1) The Company reclassified aggregate rebates and allowances of $ 19.1 million and $ 16.6 million for the years ended December 31, 2020 and 2019, respectively, which included $ 17.5 million and $ 15.1 million for DEFINITY, $ 1.3 million and $ 1.1 million for TechneLite and $ 0.3 million for other precision diagnostics. Product Revenue, Net The Company sells its products principally to clinics, distributors, group practices, hospitals, integrated delivery networks and radiopharmacies. The Company considers customer purchase orders, which in some cases are governed by master sales or group purchasing organization agreements, to be the contracts with a customer. For each contract, the Company considers the promise to transfer products, each of which is distinct, to be the identified performance obligations. In determining the transaction price, the Company evaluates whether the price is subject to refund or adjustment to determine the net consideration to which the Company expects to be entitled. 94 Table of Contents The Company typically invoices customers upon satisfaction of identified performance obligations. As the Company’s standard payment terms are 30 to 60 days from invoicing, the Company has elected to use the significant financing component practical expedient. The Company allocates the transaction price to each distinct product based on their relative standalone selling price. The product price as specified on the purchase order is considered the standalone selling price as it is an observable input which depicts the price as if sold to a similar customer in similar circumstances. Revenue is recognized when control of the product is transferred to the customer (i.e., when the Company’s performance obligation is satisfied), which typically occurs upon delivery to the customer. Further, in determining whether control has transferred, the Company considers if there is a present right to payment and legal title, along with risks and rewards of ownership having transferred to the customer. Frequently, the Company receives orders for products to be delivered over multiple dates that may extend across several reporting periods. The Company invoices for each delivery upon shipment and recognizes revenues for each distinct product delivered, assuming transfer of control has occurred. The Company generally does not separately charge customers for shipping and handling costs, but any shipping and handling costs charged to customers are included in product revenue, net. Taxes collected from customers relating to product sales and remitted to governmental authorities are excluded from revenues. Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established for discounts, returns, rebates and allowances that are offered within contracts between the Company and its customers. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as a current liability. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect product revenue and earnings in the period such variances become known. Rebates and Allowances: The Company provides certain customers with rebates and allowances that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. The Company establishes a liability for such amounts, which is included in accrued expenses in the accompanying consolidated balance sheets. These rebates and allowances result from performance-based offers that are primarily based on attaining contractually specified sales volumes and administrative fees the Company is required to pay to group purchasing organizations. The Company estimates the amount of rebates and allowances that are explicitly stated in the Company’s contracts based on a combination of actual purchases and an estimate of the customer’s buying patterns. Product Returns: The Company generally offers customers a limited right of return due to non-conforming product. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities using its historical product return information and considers other factors that it believes could significantly impact its expected returns, including product recalls. Reserves for product returns are not significant to the Company due to the nature of its products including radiopharmaceutical products with limited half-lives. 95 Table of Contents An analysis of the amount of, and change in, reserves is summarized as follows: (in thousands) Rebates and Allowances Balance, January 1, 2020 $ 6,985 Provision related to current period revenues 19,675 Adjustments relating to prior period revenues ( 604 ) Payments or credits made during the period ( 16,706 ) Balance, December 31, 2020 9,350 Provision related to current period revenues 25,772 Adjustments relating to prior period revenues 14 Payments or credits made during the period ( 24,159 ) Balance, December 31, 2021 $ 10,977 License and Royalty Revenues The Company has entered into licensing agreements, under which it licenses certain rights to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of licensed products. The Company also has distribution licenses which are treated as combined performance obligations with the delivery of its products and are classified as product revenue, net. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the five-step approach stated earlier. The Company uses judgment in determining the number of performance obligations in a license agreement by assessing whether the license is distinct or should be combined with another performance obligation, as well as the nature of the license. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include market conditions, reimbursement rates for personnel costs, development timelines and probabilities of regulatory success. Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments: At the inception of each arrangement that includes development or sales milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are outside the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license and royalty revenues and earnings in the period of adjustment. At December 31, 2021, the Company is constraining variable consideration related to development milestone payments requiring regulatory approvals and sales milestone payments related to achievement of certain sales targets. Royalty Revenues: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). 96 Table of Contents Contract Costs The Company recognizes an asset for incremental costs of obtaining a contract with a customer if it expects to recover those costs. The Company’s sales incentive compensation plans qualify for capitalization since these plans are directly related to sales achieved during a period of time. However, the Company has elected the practical expedient to expense the costs as they are incurred, within sales and marketing expenses, since the amortization period is less than one year. The Company recognized certain revenues as follows: Year Ended December 31, (in thousands) 2021 2020 Amounts included in the contract liability at the beginning of the period $ 33 $ 33 The Company did not record any revenue related to performance obligations satisfied (or partially satisfied) in previous periods during the years ended December 31, 2021 and 2020. The Company’s performance obligations are typically part of contracts that have an original expected duration of one year or less. As such, the Company is not disclosing the aggregate amount of the transaction price allocated to performance obligations that are unsatisfied (or partially satisfied) as of the end of the reporting period. 97 Table of Contents 4. Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability of fair value measurements, financial instruments are categorized based on a hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: • Level 1 — Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. • Level 2 — Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs). • Level 3 — Unobservable inputs that reflect a Company’s estimates about the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data. The Company’s financial assets and liabilities measured at fair value on a recurring basis consist of money market funds, interest rate swaps, a contingent receivable and contingent consideration liabilities. The Company invests excess cash from its operating cash accounts in overnight investments and reflects these amounts in cash and cash equivalents in the consolidated balance sheets at fair value using quoted prices in active markets for identical assets. The fair value of the interest rate swaps is determined based on observable market-based inputs, including interest rate curves and reflects the contractual terms of these instruments, including the period to maturity. Please refer to Note 14, “Derivative Instruments”, for further details on the interest rate swaps. The Company recorded a contingent receivable and the contingent consideration liabilities resulting from the Progenics Acquisition at fair value based on inputs that are not observable in the market. Please refer to Note 8, “Business Combinations”, for further details on the acquisition. The tables below present information about the Company’s assets and liabilities measured at fair value on a recurring basis: December 31, 2021 (in thousands) Total Fair Value Level 1 Level 2 Level 3 Assets: Money market $ 40,140 $ 40,140 $ — $ — Interest rate swaps 357 — 357 — Contingent receivable 9,300 — — 9,300 Total assets $ 49,797 $ 40,140 $ 357 $ 9,300 Liabilities: Contingent consideration liabilities $ 86,200 $ — $ — $ 86,200 Total liabilities $ 86,200 $ — $ — $ 86,200 December 31, 2020 (in thousands) Total Fair Value Level 1 Level 2 Level 3 Assets: Money market $ 35,457 $ 35,457 $ — $ — Contingent receivable 11,300 — — 11,300 Total assets $ 46,757 $ 35,457 $ — $ 11,300 Liabilities: Interest rate swaps $ 1,908 $ — $ 1,908 $ — Contingent consideration liabilities 15,800 — — 15,800 Total liabilities $ 17,708 $ — $ 1,908 $ 15,800 During the years ended December 31, 2021 and 2020, there were no transfers into or out of Level 3. 98 Table of Contents As part of the Progenics Acquisition, the Company acquired the right to receive certain future milestone and royalty payments due to Progenics from CytoDyn Inc. related to a prior sale of certain intellectual property. The Company has the right to receive $ 5.0 million upon regulatory approval and a 5 % royalty on net sales of approved products. The Company considers the contingent receivable a Level 3 instrument (one with significant unobservable inputs) in the fair value hierarchy. The estimated fair value was determined based on probability adjusted discounted cash flows that included significant estimates and assumptions pertaining to regulatory events and sales targets. The most significant unobservable inputs are the probabilities of achieving regulatory approval of the development projects and subsequent commercial success. As part of the Progenics Acquisition, the Company issued CVRs and recorded the fair value as part of consideration transferred. Each CVR will entitle its holder to receive a pro rata share of aggregate cash payments equal to 40 % of U.S. net sales generated by PYLARIFY in 2022 and 2023 in excess of $ 100.0 million and $ 150.0 million, respectively. Refer to Note 1, “Description of Business” for further details on the CVRs. Additionally, the Company assumed contingent consideration liabilities related to a previous acquisition completed by Progenics in 2013 (“2013 Acquisition”). These contingent consideration liabilities include potential payments of up to $ 70.0 million if the Company attains certain net sales targets primarily for AZEDRA and 1095 and a $ 5.0 million 1095 commercialization milestone. Additionally, there is a potential payment of up to $ 10.0 million related to a 1404 commercialization milestone. The Company’s total potential payments related to the 2013 Acquisition are approximately $ 85.0 million. The Company considers the contingent consideration liabilities relating to the CVRs and the 2013 Acquisition, each a Level 3 instrument (one with significant unobservable inputs) in the fair value hierarchy. The estimated fair value of these was determined based on probability adjusted discounted cash flows and Monte Carlo simulation models that included significant estimates and assumptions pertaining to commercialization events and sales targets. The most significant unobservable inputs are the probabilities of achieving regulatory approval of the development projects and subsequent commercial success. Significant changes in any of the probabilities of success, the probabilities as to the periods in which sales targets and milestones will be achieved, discount rates or underlying revenue forecasts would result in a significantly higher or lower fair value measurement. The Company records the contingent consideration liability at fair value with changes in estimated fair values recorded in general and administrative expenses in the consolidated statements of operations. The Company can give no assurance that the actual amounts paid, if any, in connection with the contingent consideration liabilities, including the CVRs, will be consistent with any recurring fair value estimate of such contingent consideration liabilities. The following tables summarize quantitative information and assumptions pertaining to the fair value measurement of assets and liabilities using Level 3 inputs as of December 31, 2021. Fair Value as of Assumptions (in thousands) December 31, 2021 December 31, 2020 Valuation Technique Unobservable Input December 31, 2021 December 31, 2020 Contingent receivable: Regulatory milestone $ 2,500 $ 3,200 Probability adjusted discounted cash flow model Period of expected milestone achievement 2022 2021 Probability of success 70 % 90 % Discount rate 17 % 24 % Royalties 6,800 8,100 Probability adjusted discounted cash flow model Probability of success 10 % - 60 % 13 % - 77 % Discount rate 17 % 24 % Total $ 9,300 $ 11,300 99 Table of Contents Fair Value as of Assumptions (in thousands) December 31, 2021 December 31, 2020 Valuation Technique Unobservable Input December 31, 2021 December 31, 2020 Contingent consideration liability: Net sales targets - PYLARIFY (CVRs) $ 73,200 $ 4,200 Monte Carlo simulation Period of expected milestone achievement and sales targets 2022 - 2023 2022 - 2023 Discount rate 17 % 24 % 1095 commercialization milestone 1,900 2,200 Probability adjusted discounted cash flow model Period of expected milestone achievement 2026 2026 Probability of success 40 % 45 % Discount rate 1.3 % 0.5 % Net sales targets - AZEDRA and 1095 11,100 9,400 Monte Carlo simulation Probability of success and sales targets 40 % - 100 % 40 % - 100 % Discount rate 16 % - 17 % 23 % - 24 % Total $ 86,200 $ 15,800 For those financial instruments with significant Level 3 inputs, the following table summarizes the activities for the periods indicated: Financial Assets Financial Liabilities (in thousands) Years Ended December 31, Years Ended December 31, 2021 2020 2021 2020 Fair value, beginning of period $ 11,300 $ — $ 15,800 $ — Progenics acquisition — 10,100 — 16,600 Changes in fair value included in net loss ( 2,000 ) 1,200 70,400 ( 800 ) Fair value, end of period $ 9,300 $ 11,300 $ 86,200 $ 15,800 The change in fair value of the contingent financial asset and contingent financial liabilities, including the CVRs, resulted in an expense of $ 72.4 million for the year ended December 31, 2021 and was primarily due to changes in revenue forecasts, changes in market conditions, a decrease in discount rates and the passage of time. 100 Table of Contents 5. Income Taxes The components of income before income taxes is summarized as follows: Year Ended December 31, (in thousands) 2021 2020 2019 U.S. $ ( 76,389 ) $ ( 5,495 ) $ 25,432 International 1,351 ( 5,984 ) 3,195 (Loss) income before income taxes $ ( 75,038 ) $ ( 11,479 ) $ 28,627 The income tax (benefit) expense is summarized as follows: Year Ended December 31, (in thousands) 2021 2020 2019 Current Federal $ — $ — $ 287 State ( 8,166 ) 3,158 ( 13,166 ) International ( 30 ) 170 114 ( 8,196 ) 3,328 ( 12,765 ) Deferred Federal 1,048 ( 1,506 ) 8,712 State 3,058 ( 178 ) 790 International 331 350 223 4,437 ( 1,334 ) 9,725 Income tax (benefit) expense $ ( 3,759 ) $ 1,994 $ ( 3,040 ) The reconciliation of income taxes at the U.S. federal statutory rate to the actual income taxes is as follows: Year Ended December 31, (in thousands) 2021 2020 2019 U.S. statutory rate $ ( 15,758 ) $ ( 2,411 ) $ 6,012 Permanent items 1,764 1,176 3,210 Acquisition costs - Progenics — 2,723 — Recognition of deferred tax asset - assets held for sale — ( 3,000 ) — Section 162(m) 1,028 717 527 Uncertain tax positions ( 8,952 ) 2,818 ( 13,156 ) Other tax credits ( 990 ) ( 1,065 ) ( 1,685 ) State and local taxes 656 1,457 1,914 Impact on deferred taxes of change in tax rate 3,049 — — Non-deductible changes in fair value of contingent assets and liabilities 15,015 230 — Foreign tax rate differential 23 ( 254 ) ( 238 ) Valuation allowance ( 400 ) ( 318 ) ( 22 ) Benefit of windfall related to stock compensation ( 1,164 ) ( 128 ) ( 2,768 ) Change in indemnification deferred tax asset 1,786 ( 590 ) 2,531 Other 184 639 635 Income tax (benefit) expense $ ( 3,759 ) $ 1,994 $ ( 3,040 ) The components of deferred income tax assets (liabilities) are as follows: 101 Table of Contents December 31, (in thousands) 2021 2020 Deferred Tax Assets Federal benefit of state tax liabilities $ 4,292 $ 5,867 Reserves, accruals and other 27,159 32,030 Inventory obsolescence 297 404 Capitalized research and development 768 2,553 Amortization of intangibles other than goodwill 502 1,325 Net operating loss carryforwards 122,944 127,369 Depreciation 1,102 1,014 Deferred tax assets 157,064 170,562 Deferred Tax Liabilities Reserves, accruals and other ( 3,026 ) ( 5,676 ) Intangible assets ( 87,351 ) ( 91,283 ) Deferred tax liability ( 90,377 ) ( 96,959 ) Less: valuation allowance ( 3,923 ) ( 3,456 ) $ 62,764 $ 70,147 Recorded in the accompanying consolidated balance sheets as: Noncurrent deferred tax assets, net $ 62,764 $ 70,147 On June 19, 2020, the Company completed the Progenics Acquisition in a transaction that is expected to qualify as a tax-deferred reorganization under Section 368 of the Internal Revenue Code. The transaction resulted in an ownership change of Progenics under Section 382 of the Internal Revenue Code, and a limitation on the utilization of Progenics’ precombination tax attributes. All of Progenics’ precombination research credits and Orphan drug credits have been removed from the balance sheet, and the gross carrying value of the tax loss carryforwards reduced to their realizable value on the opening balance sheet, in accordance with the Section 382 limitation. Deferred tax liabilities of $ 92.3 million on acquired identified intangibles were recorded at acquisition resulting in a small net overall deferred tax liability for Progenics after the application of acquisition accounting. The Company also acquired estimated utilizable U.S. federal loss carryforwards of $ 338.7 million, tax-effected state loss carryforwards of $ 12.5 million and state tax credits of $ 2.5 million as a result of the Progenics acquisition. The utilization of these losses and credits is subject to annual limitations based on Sections 382 and 383 of the Internal Revenue Code. The Company regularly assesses its ability to realize its deferred tax assets. Assessing the realizability of deferred tax assets requires significant management judgment. In determining whether its deferred tax assets are more-likely-than-not realizable, the Company evaluated all available positive and negative evidence, and weighed the objective evidence and expected impact. The Company continues to record valuation allowances of $ 1.2 million against the net deferred tax assets of its U.K. subsidiary, $ 1.9 million against the net deferred tax assets of its Sweden subsidiary, and $ 0.8 million against certain domestic state tax credits and state loss carryforwards. The Company will continue to assess the level of the valuation allowance required. If the weight of negative evidence exists in future periods to again support the recording of a partial or full valuation allowance against the Company’s deferred tax assets, there would likely be a material negative impact on the Company’s results of operations in that future period. A summary of the changes in the Company’s valuation allowance is summarized below: 102 Table of Contents (in thousands) Amount Balance, January 1, 2020 $ 1,238 Charged to income tax (benefit) expense 311 Foreign currency 31 Increase due to Progenics acquisition 2,479 Release valuation allowance ( 603 ) Balance, December 31, 2020 3,456 Charged to income tax (benefit) expense ( 189 ) Adjustment related to Progenics acquired deferred assets 867 Foreign currency ( 211 ) Balance, December 31, 2021 $ 3,923 The Company’s U.S. federal income tax returns are subject to examination for three years after the filing date of the return. The state and foreign income tax returns are subject to examination for periods varying from three to four years after filing, depending on the specific jurisdictions’ statutes of limitation, and in the case of Sweden, up to six years after the end of the financial year. At December 31, 2021, the Company has U.S. federal net operating loss carryovers of approximately $ 476.2 million, $ 338.1 million of which will expire between 2022 and 2037, and $ 138.0 million of which can be carried forward indefinitely. The Company’s state net operating losses are $ 17.4 million on a tax-effected basis, which will expire between 2022 and 2040. The Company also has U.S. federal research credits carryforwards of $ 3.4 million which will begin to expire in 2037. The Company has state research credit carryforwards of $ 3.1 million, which will expire between 2024 and 2036. The Company has state investment tax credit carryforwards of $ 1.7 million net of federal impact, $ 0.7 million of which have no expiration date, and $ 1.0 million of which will expire between 2022 and 2024. A reconciliation of the Company’s changes in uncertain tax positions for 2021 and 2020 is as follows: (in thousands) Amount Balance of uncertain tax positions as of January 1, 2020 $ 5,292 Additions related to current year tax positions — Reductions related to prior year tax positions — Settlements — Lapse of statute of limitations — Balance of uncertain tax positions as of December 31, 2020 5,292 Additions related to current year tax positions — Reductions related to prior year tax positions ( 188 ) Settlements ( 1,446 ) Lapse of statute of limitations — Balance of uncertain tax positions as of December 31, 2021 $ 3,658 In connection with the Company’s acquisition of the medical imaging business from Bristol-Myers Squibb (“BMS”) in 2008, the Company recorded a liability for uncertain tax positions related to the acquired business and simultaneously entered into a tax indemnification agreement with BMS under which BMS agreed to indemnify the Company for any payments made to settle those uncertain tax positions with the taxing authorities. A long-term receivable is recorded within other long-term assets to account for the expected value to the Company of future indemnification payments, net of actual tax benefits received, to be paid on behalf of the Company by BMS. In accordance with the Company’s accounting policy, the change in the tax liability, penalties and interest associated with these obligations (net of any offsetting federal or state benefit) is recognized within income tax expense. As these reserves change, adjustments are included in income tax expense while the offsetting adjustment is included in other income. Assuming that the receivable from BMS continues to be considered recoverable by the Company, there will be no effect on net income and no net cash outflows related to these liabilities. As of December 31, 2021 and 2020, total liabilities for uncertain tax positions including interest and penalties were $ 20.9 million and $ 29.9 million, respectively, consisting of uncertain tax positions of $ 3.7 million and $ 5.3 million, respectively, interest accruals of 103 Table of Contents $ 16.5 million and $ 23.5 million, respectively, and penalty accruals of $ 0.8 million and $ 1.0 million, respectively. As of December 31, 2021 and 2020, these liabilities were included in other long-term liabilities. Included in the 2021, 2020 and 2019 tax provisions are a benefit of $ 9.0 million, an expense of $ 2.8 million and a benefit of $ 13.2 million, respectively, relating to accrual of interest, net of benefits for reversals of uncertain tax positions recognized upon settlements, effective settlements, or lapses of relevant statutes of limitation. The total long-term asset related to the indemnification was $ 13.5 million and $ 20.8 million at December 31, 2021 and 2020, respectively. Included in other (income) loss for the years ended December 31, 2021, 2020 and 2019, is tax indemnification expense (income), net of $ 7.1 million, $( 2.2 ) million and $ 10.6 million, respectively. The Coronavirus Aid, Relief, and Economic Security Act, also known as the CARES Act, was passed by the Congress and signed into law on March 27, 2020. The Company has reviewed the relevant measures of the Act. No material impacts of the Cares Act have been identified nor are any anticipated. On December 27, 2020, the Taxpayer Certainty and Disaster Tax Relief Act of 2020 was signed into law, modifying certain aspects of the CARES Act. The Company has analyzed the CARES Act and determined that the Act to date has had no material impact on the Company’s income taxes. 6. Inventory Inventory consisted of the following: December 31, (in thousands) 2021 2020 Raw materials $ 15,505 $ 16,000 Work in process 13,042 11,212 Finished goods 6,582 8,532 Total inventory $ 35,129 $ 35,744 Inventory costs associated with products that have not yet received regulatory approval are capitalized if the Company believes there is probable future commercial use of the product and future economic benefit of the asset. If future commercial use of the product is not probable, then inventory costs associated with such product are expensed during the period the costs are incurred. As of December 31, 2021, the Company had $ 6.1 million of such product costs included in inventories related to DEFINITY that have been manufactured through the Company’s in-house manufacturing capabilities, which is awaiting regulatory approval. 7. Property, Plant and Equipment, Net Property, plant and equipment, net, consisted of the following: December 31, (in thousands) 2021 2020 Land $ 13,450 $ 13,450 Buildings 73,559 70,381 Machinery, equipment and fixtures 83,608 77,854 Computer software 24,384 23,644 Construction in progress 10,686 11,254 205,687 196,583 Less: accumulated depreciation and amortization ( 88,915 ) ( 76,412 ) Total property, plant and equipment, net $ 116,772 $ 120,171 Depreciation and amortization expense related to property, plant & equipment, net, was $ 13.2 million, $ 12.5 million and $ 10.3 million for the years ended December 31, 2021, 2020 and 2019, respectively. The Company tests long-lived assets for recoverability whenever events or changes in circumstances suggest that the carrying value of an asset or group of assets may not be recoverable. During the year ended December 31, 2021, the Company reviewed certain facts relating to an asset group that included the right-of-use (“ROU”) asset associated with the lease of office space in the World Trade Center (the “WTC lease”) in New York City and resulted in a change to the asset group due to the negotiation of a sublease. Please refer to Note 17, “Leases” for further details. 104 Table of Contents During the three months ended March 31, 2020, as a result of a decline in expected future cash flows and the effect of the COVID-19 pandemic related to certain other nuclear legacy manufacturing assets, the Company determined certain impairment triggers had occurred. Accordingly, the Company performed an undiscounted cash flow analysis as of March 31, 2020. Based on the undiscounted cash flow analysis, the Company determined that the manufacturing assets had net carrying values that exceeded their estimated undiscounted future cash flows. The Company then estimated the fair values of the asset group based on their discounted cash flows. The carrying value exceeded the fair value and as a result, the Company recorded a non-cash impairment of $ 7.3 million for the year ended December 31, 2020 in cost of goods sold in the consolidated statement of operations. In connection with a contract termination in the fourth quarter of 2020, the Company transferred ownership of certain manufacturing assets and recorded a non-cash loss on disposal of assets of $ 1.8 million as well as paid $ 0.5 million, all of which is recorded in cost of goods sold in the consolidated statement of operations. 8. Business Combinations On June 19, 2020, the Company completed the Progenics Acquisition. The acquisition combined the commercialization, supply chain and manufacturing expertise of the Company with the currently commercialized products and research and development pipeline of Progenics. Progenics brought to the Company several commercial products and a pipeline of product candidates that further diversify the Company’s commercial and clinical development portfolios. Under the terms of the Merger Agreement, the Company acquired all the issued and outstanding shares of Progenics common stock for a purchase price of $ 419.0 million by means of an all-stock transaction, which includes options to purchase Holdings common stock (“Replacement Stock Options”) for precombination services as well as CVRs. The CVRs were accounted for as contingent consideration, the fair value of which was determined using a Monte Carlo simulation. Additionally, the fair value of the Replacement Stock Options was recorded as a component of consideration transferred. Finally, as a result of the Progenics Acquisition, Lantheus effectively settled an existing bridge loan with Progenics at the recorded amount (principal and accrued interest) of $ 10.1 million, representing the effective settlement of a preexisting relationship. This effective settlement of the bridge loan was treated as a component of consideration transferred. The Company determined that the bridge loan was at market terms and no gain or loss was recorded upon settlement. The acquisition date fair value of the consideration transferred in the acquisition consisted of the following: (in thousands) Amount Issuance of common stock $ 398,110 Fair value of replacement stock options 7,125 Fair value of bridge loan settled at close 10,074 Fair value of contingent considerations (CVRs) 3,700 Total consideration transferred $ 419,009 The transaction was accounted for as a business combination which requires that assets acquired and liabilities assumed be recognized at their fair value as of the acquisition date. While the Company uses its best estimates and assumptions as part of the purchase price allocation process to value the assets acquired and liabilities assumed on the acquisition date, its estimates and assumptions are subject to refinement. Fair value estimates are based on a complex series of judgments about future events and uncertainties and rely heavily on estimates and assumptions. The judgments used to determine the estimated fair value assigned to each class of assets acquired and liabilities assumed, as well as asset lives, can materially impact the Company’s results of operations. The Company recorded a measurement period adjustment of $ 2.6 million related to deferred taxes for the three months ended March 31, 2021, which finalized all measurement period adjustments related to the Progenics Acquisition. The following table summarizes the provisional amounts recognized for assets acquired and liabilities assumed as of the acquisition date, as well as measurement period adjustments made to the amounts initially recorded in June 2020. The measurement period adjustments primarily resulted from finalizing the fair values of certain intangible assets and liabilities, deferred taxes and other changes to certain tangible assets and liability accounts. Measurement period adjustments were recognized in the reporting period in which the adjustments were determined and calculated as if the accounting had been completed at the acquisition date. The related impact to net loss that would have been recognized in previous periods if the adjustments were recognized as of the acquisition date is immaterial to the consolidated financial statements. 105 Table of Contents (in thousands) Amounts Recognized as of Acquisition Date (as previously reported) Measurement Period Adjustments Amounts Recognized as of Acquisition Date (as adjusted) Cash and cash equivalents $ 15,421 $ — $ 15,421 Accounts receivable 5,787 — 5,787 Inventory 915 160 1,075 Other current assets 3,250 434 3,684 Property, plant and equipment 14,972 — 14,972 Identifiable intangible assets (weighted-average useful life): — — Currently marketed product ( 15 years) 142,100 800 142,900 Licenses ( 11.5 years) 87,500 ( 1,700 ) 85,800 Developed technology ( 9 years) 3,000 ( 600 ) 2,400 IPR&D 150,900 200 151,100 Other long-term assets 37,631 — 37,631 Accounts payable ( 1,616 ) — ( 1,616 ) Accrued expenses and other liabilities ( 8,207 ) ( 80 ) ( 8,287 ) Other long-term liabilities ( 30,778 ) ( 380 ) ( 31,158 ) Long-term debt and other borrowings ( 40,200 ) — ( 40,200 ) Deferred tax liabilities ( 3,717 ) ( 2,258 ) ( 5,975 ) Goodwill 42,051 3,424 45,475 Total consideration transferred $ 419,009 $ — $ 419,009 Intangible assets acquired consist of currently marketed products, licenses, developed technology and in-process research and development (“IPR&D”). The fair value of the acquired intangible assets was determined based on estimated future revenues, royalty rates and discount rates, among other variables and estimates. The acquired intangible assets subject to amortization were assigned useful lives based on the expected use of the assets and the regulatory and economic environment within which they are being used and are being amortized on a straight-line basis over the respective estimated useful lives. The estimated fair values of the IPR&D assets were determined based on the present values of the expected cash flows to be generated by the respective underlying assets. The Company used a discount rate of 23.0 % and cash flows that have been probability adjusted to reflect the risks of product commercialization, which the Company believes are appropriate and representative of market participant assumptions. As part of the Progenics Acquisition, the Company acquired the right to receive certain future milestone and royalty payments due to Progenics, related to a prior sale of certain intellectual property. The estimated fair value of the acquired contingent receivable of $ 10.1 million was determined by applying a probability adjusted discounted cash flow model based on estimated future expected payments and recorded in other long-term assets. The goodwill recognized is attributable to future technologies that are not separately identifiable that could potentially add to the currently developed and pipeline products and Progenics’ assembled workforce. Future technologies did not meet the criteria for recognition separately from goodwill because they are part of the future development and growth of the business. Goodwill of $ 45.5 million recognized in connection with the acquisition is not deductible for tax purposes. The Company recognized $ 11.9 million of acquisition-related costs, including legal, accounting, compensation arrangements and other related fees that were expensed when incurred in the year ended December 31, 2020, respectively. These costs are recorded in general and administrative expenses in the consolidated statements of operations. Progenics Pro Forma Financial Information Progenics has been included in the Company’s consolidated financial statements since the acquisition date. Progenics contributed revenues of $ 12.4 million, as well as a net loss of $ 27.1 million to the Company’s consolidated statement of operations for the year ended December 31, 2020. The following unaudited pro forma financial information presents the Company’s results as if the Progenics Acquisition had occurred on January 1, 2019: 106 Table of Contents Year Ended December 31, 2020 Year Ended December 31, 2019 (in thousands) Amount Amount Pro forma revenue $ 350,315 $ 382,323 Pro forma net loss $ 29,190 $ 42,032 The unaudited pro forma financial information for all periods presented adjusts for the effects of material business combination items, including amortization of acquired intangible assets, transaction-related costs, adjustments to interest expense related to the assumption of long-term debt, retention and severance bonuses and the corresponding income tax effects of each. These pro forma results have been prepared for comparative purposes only and do not purport to be indicative of the operating results of the Company that would have been achieved had the Progenics Acquisition actually taken place on January 1, 2019. In addition, these results are not intended to be a projection of future results and do not reflect events that may occur after the Progenics Acquisition, including, but not limited to, revenue enhancements, cost savings or operating synergies that the combined company may achieve as a result of the Progenics Acquisition. 9. Sale of Puerto Rico Subsidiary During the fourth quarter of 2020, the Company entered into a stock purchase agreement (the “SPA”) with one of its existing radiopharmacy customers to sell all the stock of its Puerto Rico radiopharmacy subsidiary. The assets were classified as held for sale and the Company determined that the fair value of the net assets being sold significantly exceeded the carrying value as of December 31, 2020. The transaction was consummated on January 29, 2021. The purchase price for the stock sale was $ 18.0 million in cash, which included a holdback amount of $ 1.8 million that was remitted to the Company as of December 31, 2021, and paid in the first quarter of 2022; the purchase price also included a working capital adjustment. The SPA contained customary representations, warranties and covenants by each of the parties. Subject to certain limitations, the buyer will be indemnified for damages resulting from breaches or inaccuracies of the Company’s representations, warranties and covenants in the SPA. As part of the transaction, the Company and the buyer also entered into a customary transition services agreement and a long-term supply contract under which the Company will supply the buyer with certain of the Company’s products on commercial terms and under which the buyer has agreed to certain product minimum purchase commitments. The Company does not believe this sale of certain net assets, reported as held for sale as of December 31, 2020, constituted a strategic shift that would have a major effect on its operations or financial results. As a result, this transaction is not classified as discontinued operations in the Company’s accompanying consolidated financial statements. The following table summarizes the major classes of assets and liabilities sold as of January 29, 2021 (date of sale) and held for sale as of December 31, 2020: 107 Table of Contents (in thousands) January 29, 2021 December 31, 2020 Current Assets: Cash and cash equivalents $ 540 $ 941 Accounts receivable, net 1,959 2,191 Inventory 530 420 Other current assets 65 43 Total current assets 3,094 3,595 Non-Current Assets: Property, plant & equipment, net 780 761 Intangibles, net 96 96 Other long-term assets 774 790 Total assets held for sale $ 4,744 $ 5,242 Current Liabilities: Accounts payable $ 185 $ 224 Accrued expense and other liabilities 369 661 Total current liabilities 554 885 Non-Current Liabilities: Asset retirement obligations 306 302 Other long-term liabilities 588 606 Total liabilities held for sale $ 1,448 $ 1,793 The sale resulted in a pre-tax book gain of $ 15.3 million, which was recorded within operating (loss) income in the consolidated statements of operations for the year ended December 31, 2021. 10. Asset Retirement Obligations The Company considers its legal obligation to remediate its facilities upon a decommissioning of its radioactive-related operations as an asset retirement obligation. The Company has production facilities which manufacture and process radioactive materials at its North Billerica, Massachusetts and Somerset, New Jersey sites. As of December 31, 2021, the liability is measured at the present value of the obligation expected to be incurred, of approximately $ 26.4 million. The Company previously operated a production facility which manufactured and processed radioactive materials at its San Juan, Puerto Rico site. As of December 31, 2020, the liability for the San Juan, Puerto Rico site was recorded in liabilities held for sale and the sale was consummated on January 29, 2021. The following table provides a summary of the changes in the Company’s asset retirement obligations: (in thousands) Amount Balance, January 1, 2021 $ 14,020 Change in useful life estimate 5,259 Accretion expense 1,554 Balance, December 31, 2021 $ 20,833 In December 2021, the Company evaluated the accretion timeline of an asset group due to a revision in the planned period of use at the North Billerica site. As a result of the accelerated timeline, the Company determined the asset group’s present value exceeded the current value recorded as of December 31, 2021. Accordingly, the Company recorded a non-cash adjustment of $ 5.3 million to anticipate a revision in the end of useful life by the end of 2022. 108 Table of Contents The Company is required to provide the Massachusetts Department of Public Health and New Jersey Department of Environmental Protection financial assurance demonstrating the Company’s ability to fund the decommissioning of its North Billerica, Massachusetts and Somerset, New Jersey production facilities upon closure, although the Company has no current plans to close the facilities. The Company has provided this financial assurance in the form of a $ 28.2 million surety bond. 11. Intangibles, Net and Goodwill Intangibles, net, consisted of the following: December 31, 2021 (in thousands) Useful Lives (in years) Amortization Method Cost Accumulated Amortization Net Trademarks 15 - 25 Straight-Line $ 13,540 $ ( 11,510 ) $ 2,030 Customer relationships 15 - 25 Accelerated 96,880 ( 94,630 ) 2,250 Currently marketed product 9 - 15 Straight-Line 275,700 ( 23,345 ) 252,355 Licenses 11 - 16 Straight-Line 85,800 ( 11,555 ) 74,245 Developed technology 9 Straight-Line 2,400 ( 410 ) 1,990 IPR&D N/A N/A 15,640 — 15,640 Total $ 489,960 $ ( 141,450 ) $ 348,510 December 31, 2020 (in thousands) Useful Lives (in years) Amortization Method Cost Accumulated Amortization Net Trademarks 15 - 25 Straight-Line $ 13,540 $ ( 10,958 ) $ 2,582 Customer relationships 15 - 25 Accelerated 96,865 ( 93,770 ) 3,095 Currently marketed product 15 Straight-Line 142,900 ( 5,053 ) 137,847 Licenses 11 - 16 Straight-Line 85,800 ( 4,008 ) 81,792 Developed technology 9 Straight-Line 2,400 ( 144 ) 2,256 IPR&D N/A N/A 148,440 — 148,440 Total $ 489,945 $ ( 113,933 ) $ 376,012 The Company recorded amortization expense for its intangible assets of $ 27.5 million, $ 10.8 million and $ 1.8 million for the years ended December 31, 2021, 2020 and 2019, respectively. In May 2021, PyL (18F-DCFPyL) was approved by the FDA under the name PYLARIFY. Accordingly, the Company reclassified the associated asset of $ 132.8 million from IPR&D to currently marketed products and commenced amortization of the asset. The Company performed its annual impairment test of its IPR&D assets as of October 31, 2020. As a result of a timing delay in the development of an AZEDRA IPR&D asset due to the impact of COVID-19, the Company determined that the carrying value of $ 18.3 million exceeded the fair value of the asset. Accordingly, the Company recorded a non-cash impairment charge of $ 2.7 million for the year ended December 31, 2020 in research and development expenses in the consolidated statements of operations. The estimated fair value of the AZEDRA IPR&D asset was determined based on the present values of the expected cash flows. The Company used a discount rate of 23.0 % and cash flows that have been probability adjusted to reflect the risks of product commercialization, which the Company believes are appropriate and representative of market participant assumptions. 109 Table of Contents The below table summarizes the estimated aggregate amortization expense expected to be recognized on the above intangible assets: (in thousands) Amount 2022 $ 33,229 2023 32,634 2024 32,563 2025 32,508 2026 32,497 2027 and thereafter 169,439 Total $ 332,870 Changes in the carrying amounts of goodwill for the years ended December 31, 2021 and 2020, were as follows: December 31, (in thousands) 2021 2020 Balance, Beginning of year $ 58,632 $ 15,714 Increase from acquisition 2,557 42,918 Balance, End of year $ 61,189 $ 58,632 12. Accrued Expenses and Other Liabilities and Other Long-Term Liabilities Accrued expenses and other liabilities and other long-term liabilities are comprised of the following: December 31, (in thousands) 2021 2020 Compensation and benefits $ 22,730 $ 17,669 Freight, distribution and operations 16,157 5,653 Accrued rebates, discounts and chargebacks 10,977 9,350 Accrued professional fees 2,850 2,925 Other 5,354 6,129 Total accrued expenses and other liabilities $ 58,068 $ 41,726 Operating lease liabilities (Note 17) $ 16,546 $ 17,501 Long-term contingent liability (Note 4) 86,200 15,800 Other long-term liabilities 22,148 30,092 Total other long-term liabilities $ 124,894 $ 63,393 13. Long-Term Debt, Net, and Other Borrowings As of December 31, 2021, the Company’s maturities of principal obligations under its long-term debt and other borrowings are as follows: 110 Table of Contents (in thousands) Amount 2022 $ 11,250 2023 15,000 2024 148,750 Total principal outstanding 175,000 Unamortized debt discount ( 498 ) Unamortized debt issuance costs ( 430 ) Finance lease liabilities 691 Total 174,763 Less: current portion ( 11,642 ) Total long-term debt, net, and other borrowings $ 163,121 In June 2019, the Company refinanced its previous $ 275.0 million five-year term loan agreement (the “2017 Term Facility”) with a new five-year $ 200.0 million term loan facility (the “2019 Term Facility” and the loans thereunder, the “2019 Term Loans”). In addition, the Company replaced its previous $ 75.0 million five-year revolving credit facility (the “2017 Revolving Facility”) with a new $ 200.0 million five-year revolving credit facility (the “2019 Revolving Facility” and, together with the 2019 Term Facility, the “2019 Facility”). The terms of the 2019 Facility are set forth in the Credit Agreement, dated as of June 27, 2019 (as amended, the “2019 Credit Agreement”), by and among Holdings, the Company, the lenders from time to time party thereto and Wells Fargo Bank, N.A., as administrative agent and collateral agent. The Company has the right to request an increase to the 2019 Term Facility or request the establishment of one or more new incremental term loan facilities, in an aggregate principal amount of up to $ 100.0 million, plus additional amounts, in certain circumstances. The net proceeds of the 2019 Term Facility, together with approximately $ 73.0 million of cash on hand, were used to refinance in full the aggregate remaining principal amount of the loans outstanding under the 2017 Term Facility and pay related interest, transaction fees and expenses. No amounts were outstanding under the 2017 Revolving Facility at that time. The Company accounted for the refinancing of the 2017 Term Facility as a debt extinguishment and the 2017 Revolving Facility as a debt modification by evaluating the refinancing on a creditor by creditor basis. The Company recorded a loss on extinguishment of debt of $ 3.2 million related to the write-off of unamortized debt issuance costs and debt discounts. In addition, the Company incurred and capitalized $ 2.8 million of new debt issuance costs and debt discounts related to the refinancing. 2019 Term Facility The 2019 Term Loans under the 2019 Term Facility bear interest, with pricing based from time to time at the Company’s election at (i) LIBOR plus a spread ranging from 1.25 % to 2.25 % as determined by the Company’s total net leverage ratio (as defined in the 2019 Credit Agreement) or (ii) the Base Rate (as defined in the 2019 Credit Agreement) plus a spread ranging from 0.25 % to 1.25 % as determined by the Company’s total net leverage ratio. The use of LIBOR, as it relates to the Company’s 2019 Term Facility, is expected to be phased out by the end of June 2023. The 2019 Credit Agreement allows for a mutually agreed replacement interest rate in the event the LIBOR is phased out. The Company is permitted to voluntarily repay the 2019 Term Loans, in whole or in part, without premium or penalty. The 2019 Term Facility requires the Company to make mandatory prepayments of the outstanding 2019 Term Loans in certain circumstances. The 2019 Term Loans mature in June 2024. At December 31, 2021, the Company’s interest rate under the 2019 Term Facility was 2.1 %. 2019 Revolving Facility Under the terms of the 2019 Revolving Facility, the lenders thereunder agreed to extend credit to the Company from time to time until June 27, 2024 consisting of revolving loans (the “Revolving Loans” and, together with the 2019 Term Loans, the “Loans”) in an aggregate principal amount not to exceed $ 200.0 million (the “Revolving Commitment”) at any time outstanding. The 2019 Revolving Facility includes a $ 20.0 million sub-facility for the issuance of Letters of Credit. The 2019 Revolving Facility includes a $ 10.0 million sub-facility for Swingline Loans. The Letters of Credit, Swingline Loans and the borrowings under the 2019 Revolving Facility are expected to be used for working capital and other general corporate purposes. The Revolving Loans under the 2019 Revolving Facility bear interest, with pricing based from time to time at the Company’s election at (i) LIBOR plus a spread ranging from 1.25 % to 2.25 % as determined by the Company’s total net leverage ratio or (ii) the Base Rate plus a spread ranging from 0.25 % to 1.25 % as determined by the Company’s total net leverage ratio. The 2019 Revolving Facility also includes a commitment fee, which ranges from 0.15 % to 0.30 % as determined by the Company’s total net leverage ratio. 111 Table of Contents The Company is permitted to voluntarily prepay the Revolving Loans, in whole or in part, or reduce or terminate the Revolving Commitment, in each case, without premium or penalty. On any business day on which the total amount of outstanding Revolving Loans and Letters of Credit exceeds the total Revolving Commitment, the Company must prepay the Revolving Loans in an amount equal to such excess. As of December 31, 2021, there were no outstanding borrowings under the 2019 Revolving Facility. 2019 Facility Covenants The 2019 Facility contains a number of affirmative, negative, reporting and financial covenants, in each case subject to certain exceptions and materiality thresholds. The 2019 Facility requires the Company to be in quarterly compliance, measured on a trailing four quarter basis, with two financial covenants. The minimum interest coverage ratio, commencing with the fiscal quarter ended September 30, 2019, must be at least 3.00 to 1.00. The Company may elect to increase the maximum total net leverage ratio by 0.50 to 1.00 (subject to a maximum of 4.25 to 1.00) up to two separate times during the term of the 2019 Facility in connection with any Material Acquisition (as defined in the Credit Agreement). The 2019 Facility contains usual and customary restrictions on the ability of the Company and its subsidiaries to: (i) incur additional indebtedness (ii) create liens; (iii) consolidate, merge, sell or otherwise dispose of all or substantially all of its assets; (iv) sell certain assets; (v) pay dividends on, repurchase or make distributions in respect of capital stock or make other restricted payments; (vi) make certain investments; (vii) repay subordinated indebtedness prior to stated maturity; and (viii) enter into certain transactions with its affiliates. Upon an event of default, the administrative agent under the Credit Agreement will have the right to declare the Loans and other obligations outstanding immediately due and payable and all commitments immediately terminated or reduced. The 2019 Facility is guaranteed by Holdings, Progenics and Lantheus MI Real Estate, LLC, and obligations under the 2019 Facility are generally secured by first priority liens over substantially all of the assets of each of LMI, Holdings, Progenics and Lantheus MI Real Estate, LLC (subject to customary exclusions set forth in the transaction documents) owned as of June 27, 2019 or thereafter acquired. 2020 Amendment On June 19, 2020, the Company amended its 2019 Credit Agreement (the “Amendment”) as a result of the impact of the COVID-19 pandemic on the business and operations of the Company and the near-term higher level of indebtedness resulting from the Company’s decision not to immediately repay the Progenics debt secured by the RELISTOR royalties following the Progenics Acquisition. The Company accounted for the Amendment as a debt modification and capitalized $ 1.2 million of associated costs. The Amendment provides for, among other things, modifications to LMI’s financial maintenance covenants. The covenant related to Total Net Leverage Ratio (as defined in the Amended Credit Agreement) was waived from the date of the Amendment through December 31, 2020. The maximum total net leverage ratio and interest coverage ratio permitted by the financial covenant is displayed in the table below: 2019 Credit Agreement Period Total Net Leverage Ratio Q3 2021 and thereafter 3.50 to 1.00 Period Interest Coverage Ratio Q2 2021 and thereafter 3.00 to 1.00 Under the 2019 Credit Agreement, loans bear interest at LIBOR plus a spread that ranges from 1.50 % to 3.00 % or the Base Rate plus a spread that ranges from 0.50 % to 2.00 %, and the commitment fee ranges from 0.15 % to 0.40 %, in each case based on LMI’s Total Net Leverage Ratio. Royalty-Backed Loan On June 19, 2020, as a result of the acquisition, the Company assumed Progenics outstanding debt as of such date in the amount of $ 40.2 million. Progenics, through a wholly-owned subsidiary MNTX Royalties Sub LLC (“MNTX Royalties”), entered into a $ 50.0 million loan agreement (the “Royalty-Backed Loan”) with a fund managed by HealthCare Royalty Partners III, L.P. (“HCRP”) on November 4, 2016. The Royalty-Backed Loan bore interest at a per annum rate of 9.5 % and was scheduled to mature on June 30, 2025. On June 22, 2020, HCRP waived the automatic acceleration of the Royalty-Backed Loan that otherwise would have been 112 Table of Contents triggered by the consummation of the Progenics Acquisition and MNTX Royalties agreed not to prepay the loan until after December 31, 2020. On March 31, 2021, the Company voluntarily repaid in full the entire outstanding principal on the Royalty-Backed Loan in the amount of $ 30.9 million, which included a prepayment amount of $ 0.5 million, and terminated the agreement governing the Royalty-Backed Loan. The Company recorded a gain on extinguishment of debt of $ 0.9 million related to the write-off of an unamortized debt premium offset by the prepayment amount. 14. Derivative Instruments The Company uses interest rate swaps to reduce the variability in cash flows associated with a portion of the Company’s forecasted interest payments on its variable rate debt. In March 2020, the Company entered into interest rate swap contracts to fix the LIBOR rate on a notional amount of $ 100.0 million through May 31, 2024. The average fixed LIBOR rate on the interest rate swaps is approximately 0.82 %. This agreement involves the receipt of floating rate amounts in exchange for fixed rate interest payments over the life of the agreement without an exchange of the underlying principal amount. The interest rate swaps were designated as cash flow hedges. In accordance with hedge accounting, the interest rate swaps are recorded on the Company’s consolidated balance sheets at fair value, and changes in the fair value of the swap agreements are recorded to other comprehensive loss and reclassified to interest expense in the period during which the hedged transaction affected earnings or it will become probable that the forecasted transaction would not occur. At December 31, 2021, accumulated other comprehensive loss included $ 0.3 million of pre-tax deferred losses that are expected to be reclassified to earnings during the next 12 months. The following table presents the location and fair value amounts of derivative instruments reported in the consolidated balance sheet: (in thousands) December 31, 2021 December 31, 2020 Derivatives type Classification Assets: Interest rate swap Other long-term assets $ 357 $ — Liabilities: Interest rate swap Accrued expenses and other liabilities $ — $ 1,908 15. Accumulated Other Comprehensive Loss The components of Accumulated Other Comprehensive Loss, net of tax of $ 0.1 million and $ 0.5 million for the year ended December 31, 2021 and 2020, respectively, consisted of the following: (in thousands) Foreign currency translation Unrealized loss on cash flow hedges Accumulated other comprehensive loss Balance at January 1, 2021 $ ( 630 ) $ ( 1,418 ) $ ( 2,048 ) Other comprehensive income (loss) before reclassifications ( 124 ) 962 838 Amounts reclassified to earnings — 725 725 Balance at December 31, 2021 $ ( 754 ) $ 269 $ ( 485 ) Balance at January 1, 2020 $ ( 960 ) $ — $ ( 960 ) Other comprehensive income (loss) before reclassifications 330 ( 1,833 ) ( 1,503 ) Amounts reclassified to earnings — 415 415 Balance at December 31, 2020 $ ( 630 ) $ ( 1,418 ) $ ( 2,048 ) 113 Table of Contents 16. Stock-Based Compensation Equity Incentive Plans As of December 31, 2021, the Company’s approved equity incentive plans included the 2015 Equity Incentive Plan (“2015 Plan”), the 2013 Equity Incentive Plan (“2013 Plan”), and the 2008 Equity Incentive Plan (“2008 Plan”). These plans are administered by the Board of Directors and permit the granting of stock options, stock appreciation rights, restricted stock, restricted stock units and dividend equivalent rights to employees, officers, directors and consultants of the Company. The Company has certain stock option and restricted stock awards outstanding under each of its equity incentive plans but, upon adoption of the 2015 Plan, no longer grants new equity awards under its 2008 and 2013 Plans. The Company adopted its 2015 Plan in June 2015 and subsequently amended the plan in April 2016, 2017, 2019 and 2021, which increased the common stock reserved for issuance under the plan to an aggregate 9,180,277 shares. The Company assumed Progenics equity plans due to the acquisition as discussed in Note 1, “Description of Business”. Stock-based compensation expense recognized in the consolidated statements of operations is summarized below: Year Ended December 31, (in thousands) 2021 2020 2019 Cost of goods sold $ 2,370 $ 2,820 $ 2,091 Sales and marketing 2,472 1,821 1,953 General and administrative 9,092 7,333 6,990 Research and development 2,000 2,101 1,458 Total stock-based compensation expense $ 15,934 $ 14,075 $ 12,492 Stock Options Stock option awards under the 2015 Plan are granted with an exercise price equal to the fair value of the Company’s common stock at the date of grant. All option awards have a ten-year contractual term. A summary of option activity for 2021 is presented below: Total Stock Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Balance at January 1, 2021 1,575,219 $ 19.03 Options granted — $ — Options exercised ( 318,662 ) $ 16.62 Options cancelled and forfeited ( 283,618 ) $ 22.74 Outstanding at December 31, 2021 972,939 $ 18.73 4.7 10,145,135 Exercisable at December 31, 2021 860,461 $ 19.12 4.3 8,672,206 No stock options were granted during the fiscal year ended December 31, 2021. During the years ended December 31, 2021, 2020 and 2019, 318,662 , 8,868 and 67,558 options were exercised having aggregate intrinsic values of $ 1.6 million, $ 0.1 million and $ 0.6 million, respectively. As of December 31, 2021, there was $ 0.6 million of unrecognized compensation expense related to outstanding stock options, which is expected to be recognized over a weighted-average period of 1.6 years. 114 Table of Contents Restricted Stock A summary of restricted stock awards and restricted stock units activity for 2021 is presented below: Shares Weighted- Average Grant Date Fair Value Per Share Nonvested balance at January 1, 2021 1,107,866 $ 16.58 Granted 1,000,259 $ 20.14 Vested ( 524,117 ) $ 16.72 Forfeited ( 253,634 ) $ 17.40 Nonvested balance at December 31, 2021 1,330,374 $ 19.04 Restricted stock generally vest over 3 years. As of December 31, 2021, there was $ 17.0 million of unrecognized compensation expense related to outstanding restricted stock, which is expected to be recognized over a weighted-average period of 2.0 years. The weighted average grant-date fair value for restricted stock granted during the fiscal years ended December 31, 2021, 2020 and 2019 was $ 20.14 , $ 15.00 and $ 23.33 per share, respectively. The total fair value of restricted stock vested in fiscal years 2021, 2020 and 2019 was $ 8.8 million, $ 7.6 million and $ 6.8 million, respectively. Total Stockholder Return Restricted Stock Awards (“TSR Awards”) During the years ended December 31, 2021, 2020 and 2019, the Company granted total stockholder return (“TSR”) Awards that include a three-year market condition where the performance measurement period is three years . Vesting of the TSR Awards is based on the Company’s level of attainment of specified TSR targets relative to the percentage appreciation of a specified index of companies for the respective three-year period and is also subject to the continued employment of the grantees. The number of shares that are earned over the performance period ranges from 0 % to 200 % of the initial award. The fair value of these awards are based on a Monte Carlo simulation valuation model with the following assumptions: Year Ended December 31, 2021 2020 2019 Expected volatility 54.0 % 53.3 % 71.7 % Risk-free interest rate 0.3 % 0.7 % 2.4 % Expected life (in years) 2.8 2.8 2.9 Expected dividend yield — — — A summary of TSR Award activity for 2021 is presented below: Shares Weighted- Average Grant Date Fair Value Per Share Nonvested balance at January 1, 2021 491,771 $ 27.58 Granted 260,748 $ 31.25 Vested ( 86,513 ) $ 22.76 Forfeited ( 75,933 ) $ 30.02 Nonvested balance at December 31, 2021 590,073 $ 30.49 As of December 31, 2021, there was $ 9.3 million of unrecognized compensation expense related to outstanding performance restricted stock which is expected to be recognized over a weighted-average period of 1.7 years. The weighted average grant-date fair value for TSR Awards granted during the fiscal years ended December 31, 2021, 2020 and 2019 was $ 31.25 , $ 23.43 and $ 39.92 per share, respectively. 17. Leases The Company determines if an arrangement is a lease at inception. The Company has operating and finance leases for vehicles, corporate offices and certain equipment. 115 Table of Contents Operating lease right-of-use (“ROU”) assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Lease agreements with lease and non-lease components are accounted for separately. As the Company’s leases do not provide an implicit rate, the Company used the incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company assumed two operating leases as a result of the Progenics acquisition related to office space at the World Trade Center in New York City, pursuant to a lease agreement expiring in September 2030 (the “WTC Lease”), and a radiopharmaceutical manufacturing facility in Somerset, New Jersey, under a sublease agreement expiring in November 2028, which were recorded as of June 19, 2020, for $ 18.6 million and $ 0.6 million, respectively. The Company entered into an operating lease related to office space in Somerset, New Jersey, under a lease agreement expiring in August 2026, which was recorded in October 2021 for $ 0.7 million. The Company excluded the Puerto Rico operating lease amounts classified as held for sale as of December 31, 2020. Leases with an initial term of 12 months or less are not recorded on the balance sheet as the Company has elected to apply the short-term lease exemption. The Company recognizes lease expense for these leases on a straight-line basis over the lease term. Operating and finance lease assets and liabilities are as follows: (in thousands) Classification December 31, 2021 December 31, 2020 Assets Operating Other long-term assets $ 8,788 $ 18,441 Finance Property, plant and equipment, net 556 525 Total leased assets $ 9,344 $ 18,966 Liabilities Current Operating Accrued expenses and other liabilities $ 1,599 $ 1,164 Finance Current portion of long-term debt and other borrowings 392 249 Noncurrent Operating Other long-term liabilities 16,546 17,501 Finance Long-term debt, net and other borrowings 299 246 Total leased liabilities $ 18,836 $ 19,160 In the third quarter of 2021, with respect to the office space in the World Trade Center, the Company negotiated a sublease agreement with an unrelated third party that was signed on October 11, 2021 (the “Sublease”) and has a term of nine years , which represents the remaining term of the WTC Lease. Both the WTC Lease and the Sublease are classified by the Company as operating leases. As a result of the negotiations of the Sublease, the Company determined that an impairment triggering event had occurred. Accordingly, the Company performed an undiscounted cash flow analysis related to the asset group as of September 30, 2021. Based on the undiscounted cash flow analysis, the Company determined that the asset group, including the ROU asset, had net carrying values that exceeded their estimated undiscounted future cash flows. The Company then estimated the fair value of the asset group based on its discounted cash flows. The carrying value exceeded the fair value and, as a result, the Company recorded a non-cash impairment of $ 9.5 million for the year ended December 31, 2021 in general and administrative expenses in the consolidated statements of operations. The components of lease expense were as follows: (in thousands) Year Ended December 31, 2021 Year Ended December 31, 2020 Operating lease expense $ 2,312 $ 1,471 Finance lease expense Amortization of ROU assets 330 196 Interest on lease liabilities 28 21 Short-term lease expense 8 70 Total lease expense $ 2,678 $ 1,758 116 Table of Contents Other information related to leases were as follows: December 31, 2021 December 31, 2020 Weighted-average remaining lease term (Years): Operating leases 8.6 9.7 Finance leases 2.2 2.4 Weighted-average discount rate: Operating leases 4.4 % 4.4 % Finance leases 4.6 % 5.3 % (in thousands) Year Ended December 31, 2021 Year Ended December 31, 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 2,071 $ 1,202 Operating cash flows from finance leases 28 21 Financing cash flows from finance leases 339 207 ROU assets obtained in exchange for lease obligations: Operating leases 683 19,210 Finance leases 556 373 Future minimum lease payments under non-cancellable leases as of December 31, 2021 were as follows: (in thousands) Operating Leases Finance Leases 2022 $ 2,359 $ 406 2023 2,404 268 2024 2,450 105 2025 2,497 — 2026 2,491 — Thereafter 9,786 — Total future minimum lease payments 21,987 779 Less: interest 3,842 88 Total $ 18,145 $ 691 18. Other Assets Other assets are comprised of the following: December 31, (in thousands) 2021 2020 Prepaid Expenses $ 10,113 $ 9,175 Current Contingent Asset (Note 4) 2,500 — Other Current Assets 205 450 Total other current assets $ 12,818 $ 9,625 ROU Asset (Note 17) $ 8,788 $ 18,441 Long-term Contingent Asset (Note 4) 6,800 11,300 Other Long-Term Assets 23,170 30,893 Total other long-term assets $ 38,758 $ 60,634 117 Table of Contents 19. Net (Loss) Income Per Common Share A summary of net (loss) income per common share is presented below: Year Ended December 31, (in thousands, except per share amounts) 2021 2020 2019 Net (loss) income $ ( 71,279 ) $ ( 13,473 ) $ 31,667 Basic weighted-average common shares outstanding 67,486 54,134 38,988 Effect of dilutive stock options — — 75 Effect of dilutive restricted stock — — 1,050 Diluted weighted-average common shares outstanding 67,486 54,134 40,113 Basic (loss) income per common share $ ( 1.06 ) $ ( 0.25 ) $ 0.81 Diluted (loss) income per common share $ ( 1.06 ) $ ( 0.25 ) $ 0.79 Antidilutive securities excluded from diluted net (loss) income per common share 2,893 3,175 50 20. Commitments and Contingencies Purchase Commitments The Company has entered into purchasing arrangements in which minimum quantities of goods or services have been committed to be purchased on an annual basis. As of December 31, 2021, future payments required under purchase commitments are as follows: (in thousands) Amount 2022 $ 3,483 2023 3,000 Total $ 6,483 The Company has entered into agreements which contain certain percentage volume purchase requirements. The Company has excluded these future purchase commitments from the table above since there are no minimum purchase commitments or payments under these agreements. License Agreements The Company has entered into license agreements in which fixed payments have been committed to be paid on an annual basis. As of December 31, 2021, future fixed payments required under license agreements are $ 0.3 million. The Company may be required to pay additional amounts up to approximately $ 170.5 million in contingent payments under the Company’s license agreements. These contingent payments include potential milestone or contractual payment obligations contingent upon the achievement or occurrence of future milestones or events and the amounts and timing of such potential obligations are unknown or uncertain. Legal Proceedings From time to time, the Company is a party to various legal proceedings arising in the ordinary course of business. In addition, the Company has in the past been, and may in the future be, subject to investigations by governmental and regulatory authorities, which expose it to greater risks associated with litigation, regulatory or other proceedings, as a result of which the Company could be required to pay significant fines or penalties. The costs and outcome of litigation, regulatory or other proceedings cannot be predicted with certainty, and some lawsuits, claims, actions or proceedings may be disposed of unfavorably to the Company and could have a material adverse effect on the Company’s results of operations or financial condition. In addition, intellectual property disputes often have a risk of injunctive relief which, if imposed against the Company, could materially and adversely affect its financial condition or results of operations. If a matter is both probable to result in material liability and the amount of loss can be reasonably estimated, the Company estimates and discloses the possible material loss or range of loss. If such loss is not probable or cannot be reasonably estimated, a liability is not recorded in its consolidated financial statements. 118 Table of Contents As of December 31, 2021, the Company had the following material ongoing litigation in which the Company was a party: On January 31, 2022, the Company entered into a global settlement agreement with Pharma AG (“Novartis”), Advanced Accelerator Applications USA, Inc. (“AAA”), Endocyte, Inc. (“Endocyte”) and certain of their affiliates (the “Novartis Agreement”) to settle certain disputes between the parties, as further described below: German PSMA-617 Litigation On November 8, 2018, Molecular Insight Pharmaceuticals, Inc., a subsidiary of Progenics (“MIP”), filed a complaint against the University of Heidelberg (the “University”) in the District Court in Mannheim, Germany (the “German District Court” and, such litigation, the “German Litigation”). In this Complaint, MIP claimed that the discovery and development of PSMA-617 was related to work performed under a research collaboration sponsored by MIP. MIP alleged that the University breached certain contracts with MIP and that MIP is the co-owner of inventions embodied in certain worldwide patent filings related to PSMA-617 that were filed by the University. On February 27, 2019, Endocyte, a wholly owned subsidiary of Novartis, filed a motion to intervene in the German Litigation. Endocyte is the exclusive licensee of the patent rights that are the subject of the German proceedings. In connection with this dispute, MIP filed a Confirmation of Ownership with the United States Patent and Trademark Office (“USPTO”) for certain U.S. patent applications filed by the University to support MIPs claim that it is the co-owner of these pending U.S. patent applications (the “Ownership Claim”). On February 27, 2019, the German District Court set € 0.4 million as the amount MIP must deposit with the German District Court as security in the event of an unfavorable final decision on the merits of the dispute. On August 24, 2020, the German District Court issued its decision dismissing MIP’s claims, stating that MIP failed to discharge its burden of proof in the matter. MIP filed a Notice of Appeal of the German District Court’s decision on September 24, 2020 and filed its appeal brief on November 26, 2020. The University and Endocyte each filed oppositions to MIP’s Notice of Appeal on March 12, 2021 and an oral hearing for the appeal was scheduled for September 28, 2022, at the Higher Regional Court Karlsruhe. Pursuant to the terms of the Novartis Agreement, the German Litigation was dismissed and the Ownership Claim withdrawn. Post-Grant Review Proceeding On February 4, 2021, AAA, a wholly-owned subsidiary of Novartis and parent of Endocyte, filed a petition for post-grant review of U.S. Patent No. 10,640,461 (the “’461 patent”) with the Patent Trial and Appeal Board (“PTAB”) of the USPTO. The ’461 patent is owned by MIP. In the petition, AAA challenged the patentability of certain claims of the ’461 patent. The PTAB instituted Post-Grant Review proceedings (the “PGR Proceeding”) on July 29, 2021. Pursuant to the terms of the Novartis Agreement, the PGR Proceeding will be terminated. Global Settlement Agreement In addition to the dismissal of the German Litigation, the withdrawal of the Ownership Claim and the termination of the PGR Proceeding, under the Novartis Agreement, the parties will, among other things, cross-license certain patent rights to one another, and Novartis will make a $ 24.0 million lump sum payment to the Company and also reimburse the Company for certain fees and expenses the Company is required to pay to the University in connection with the German Litigation. RELISTOR European Opposition Proceedings In October 2015, Progenics received notices of opposition to three European patents relating to methylnaltrexone: EP1615646, EP2368553 and EP2368554. Notices of opposition were filed separately at the European Patent Office (the “EPO”) by each of Actavis Group PTC ehf and Fresenius Kabi Deutschland GmbH. Between May 11, 2017 and July 4, 2017, the Opposition Division of the EPO (the “Opposition Division”) provided notice that the three European patents would be revoked. Each of these matters was appealed to the Appeal Board of the EPO. On November 13, 2020, Progenics withdrew the appeal for EP2368553 and EP2368554. Notices of termination of the proceedings with revocation of the patent were issued on November 23, 2020 for both patents. Progenics continued its appeal on the revocation of the third patent, EP1615646. Oral proceedings for EP1615646 were held at the Appeal Board of the EPO on September 22, 2020. The revocation decision under appeal was set aside and the case was remitted to the Opposition Division for further prosecution. An oral hearing was held before the Opposition Division on September 27, 2021. The Opposition Division issued its final written opinion on November 11, 2021, indicating that the patent will be maintained in amended form. The final written decision of the Opposition Division was appealable to the Appeal Board of the EPO by either party. Progenics appealed this decision on January 20, 2022 to hold open its option to file Grounds for Appeal. Given that neither opponent filed an Notice of Appeal, Progenics intends to withdraw its notice to allow the patent to issue in amended form. 119 Table of Contents 21. 401(k) Plan The Company maintains a qualified 401(k) plan (the “401(k) Plan”) for its U.S. employees. The 401(k) Plan covers U.S. employees who meet certain eligibility requirements. Under the terms of the 401(k) Plan, the employees may elect to make tax-deferred contributions through payroll deductions within statutory and plan limits, and the Company may elect to make non-elective discretionary contributions. The Company may also make optional contributions to the 401(k) Plan for any plan year at its discretion. Expense recognized by the Company for matching contributions made to the 401(k) Plan was $ 2.6 million, $ 0.8 million and $ 2.1 million for the years ended December 31, 2021, 2020 and 2019, respectively. 22. Segment Information In the first quarter of 2021, the Company completed the evaluation of its operating and reporting structure, including the impact on the Company’s business of the acquisition of Progenics described in Notes 1 and 8, and the sale of the Puerto Rico subsidiary in the first quarter, which resulted in a change in operating and reportable segments. The Company now operates as one business segment: the development, manufacture and sale of innovative diagnostic and therapeutic products that assist clinicians in the diagnosis and treatment of heart disease, cancer and other diseases. This conclusion reflects the Company’s focus on the performance of the business on a consolidated worldwide basis. The results of this operating segment are regularly reviewed by the Company’s chief operating decision maker, the President and Chief Executive Officer. The Company’s chief operating decision maker does not manage any part of the Company separately, and the allocation of resources and assessment of performance are based on the Company’s consolidated operating results. 23. Subsequent Events On January 31, 2022, the Company entered into a global settlement agreement with Novartis, AAA, Endocyte and their affiliates to settle certain disputes between the parties. Under the Novartis Agreement, Novartis will make a lump sum payment and reimburse the Company for certain fees and expenses in connection with the German Litigation. See Note 20, “Commitments and Contingencies”, for further details. 120 Table of Contents Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure Not applicable.