Item 8. Financial Statements and Supplementary Data
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 )
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Consolidated Balance Sheets
79
Consolidated Statements of Operations
80
Consolidated Statements of Comprehensive Income (Loss)
81
Consolidated Statements of Changes in Stockholders’ Equity
82
Consolidated Statements of Cash Flows
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Notes to Consolidated Financial Statements
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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, 2023 and 2022, the related consolidated statements of operations, comprehensive income (loss), changes in stockholders’ equity, and cash flows, for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, 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, 2023, 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 22, 2024, 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.
Intangible Assets — Non-Cash Impairment Charge for AZEDRA Intangible Asset Group — Refer to Note 10 to the financial statements
Critical Audit Matter Description
In March 2023, the Company stopped all development activities in relation to a future indication associated with AZEDRA, which was classified as an in-process research and development (“IPR&D”) intangible asset. The asset group, which consisted of the IPR&D asset and a currently marketed product (the “AZEDRA intangible asset group”), was assessed for impairment. The Company considered several factors in estimating the future projections of revenues and cash flows of the AZEDRA intangible asset group as part of the impairment testing. The Company concluded that the carrying amount exceeded the fair value of the AZEDRA intangible asset group, which had no value. As a result of such assessment, the Company recorded a non-cash impairment charge in research and development expenses relating to the IPR&D asset and a non-cash impairment charge in cost of goods sold relating to the currently marketed indication of AZEDRA in the consolidated statement of operations for the year ended December 31, 2023.
We identified management’s estimates of future projections of revenue and cash flows used to determine the fair value of the AZEDRA intangible asset group used to record the non-cash impairment charge as a critical audit matter because of the significant estimates made by management. This required a high degree of auditor judgment and an increased extent of effort when performing audit procedures to evaluate the reasonableness of management’s estimates of future projections of revenues and cash flows.
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How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to management’s estimates of future revenues and cash flows used to record the non-cash impairment charge for the AZEDRA intangible asset group included the following, among others:
• We tested the effectiveness of controls over management’s review of the estimates of future projections of revenue and cash flows used to record the non-cash impairment charge for the AZEDRA intangible asset group.
• We assessed the reasonableness of management’s estimates of future projections of revenues and cash flows for the AZEDRA intangible asset group by:
◦ Comparing historical results to the Company’s strategic plans.
◦ Making inquiries of management and corroborating inquiries with the Company’s strategic planning group.
◦ Reading internal communications to management and the Board of Directors.
• We evaluated whether the estimates of future projections of revenues and cash flows for AZEDRA were consistent with evidence obtained in other areas of the audit.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
February 22, 2024
We have served as the Company’s auditor since 2007.
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Lantheus Holdings, Inc.
Consolidated Balance Sheets
(in thousands, except par value)
December 31,
2023 2022
Assets
Current assets
Cash and cash equivalents $ 713,656 $ 415,652
Accounts receivable, net 284,292 213,397
Inventory 64,029 35,475
Other current assets 16,683 13,092
Assets held for sale 7,159 —
Total current assets 1,085,819 677,616
Property, plant and equipment, net 146,697 122,166
Intangibles, net 151,985 315,285
Goodwill 61,189 61,189
Deferred tax assets, net 150,198 110,647
Other long-term assets 55,261 34,355
Total assets $ 1,651,149 $ 1,321,258
Liabilities and stockholders’ equity
Current liabilities
Current portion of long-term debt and other borrowings $ 823 $ 354
Accounts payable 41,189 20,563
Short-term contingent liability — 99,700
Accrued expenses and other liabilities 145,338 127,084
Total current liabilities 187,350 247,701
Asset retirement obligations 22,916 22,543
Long-term debt, net and other borrowings 561,670 557,712
Other long-term liabilities 63,321 46,155
Total liabilities 835,257 874,111
Commitments and contingencies (see Note 19)
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; 69,863 and 68,851 shares issued as of December 31, 2023 and 2022, respectively)
699 689
Additional paid-in capital 757,727 715,875
Treasury Stock at cost - 1,339 shares as of December 31, 2023 and 2022
( 75,000 ) ( 75,000 )
Retained earnings (accumulated deficit) 133,503 ( 193,158 )
Accumulated other comprehensive loss ( 1,037 ) ( 1,259 )
Total stockholders’ equity 815,892 447,147
Total liabilities and stockholders’ equity $ 1,651,149 $ 1,321,258
The accompanying notes are an integral part of these consolidated financial statements.
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Lantheus Holdings, Inc.
Consolidated Statements of Operations
(in thousands, except per share data)
Year Ended
December 31,
2023 2022 2021
Revenues $ 1,296,429 $ 935,061 $ 425,208
Cost of goods sold 586,886 353,358 237,513
Gross profit 709,543 581,703 187,695
Operating expenses
Sales and marketing 141,736 100,243 68,422
General and administrative 125,458 133,584 150,395
Research and development 77,707 311,681 44,966
Total operating expenses 344,901 545,508 263,783
Gain on sales of assets — — 15,263
Operating income (loss) 364,642 36,195 ( 60,825 )
Interest expense 20,019 7,185 7,752
Loss (gain) on extinguishment of debt — 588 ( 889 )
Other (income) loss, net ( 66,320 ) 1,703 7,350
Income (loss) before income taxes 410,943 26,719 ( 75,038 )
Income tax expense (benefit) 84,282 ( 1,348 ) ( 3,759 )
Net income (loss) $ 326,661 $ 28,067 $ ( 71,279 )
Net income (loss) per common share:
Basic $ 4.79 $ 0.41 $ ( 1.06 )
Diluted $ 4.65 $ 0.40 $ ( 1.06 )
Weighted-average common shares outstanding:
Basic 68,266 68,487 67,486
Diluted 70,239 70,671 67,486
The accompanying notes are an integral part of these consolidated financial statements.
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Lantheus Holdings, Inc.
Consolidated Statements of Comprehensive Income (Loss)
(in thousands)
Year Ended
December 31,
2023 2022 2021
Net income (loss) $ 326,661 $ 28,067 $ ( 71,279 )
Other comprehensive income:
Foreign currency translation 222 ( 505 ) ( 124 )
Realized loss on cash flow hedges, net of tax — ( 269 ) —
Unrealized gain on cash flow hedges, net of tax — — 1,687
Total other comprehensive income (loss) 222 ( 774 ) 1,563
Comprehensive income (loss) $ 326,883 $ 27,293 $ ( 69,716 )
The accompanying notes are an integral part of these consolidated financial statements.
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Lantheus Holdings, Inc.
Consolidated Statements of Changes in Stockholders’ Equity
(in thousands)
Common Stock Treasury Stock Additional
Paid-In
Capital Retained Earnings Accumulated
Other
Comprehensive
Loss Total
Stockholders’
Equity
Shares Amount Shares Amount
Balance, January 1, 2021 66,875 $ 669 — $ — $ 665,530 $ ( 149,946 ) $ ( 2,048 ) $ 514,205
Net loss — — — — — ( 71,279 ) — ( 71,279 )
Other comprehensive loss — — — — — — 1,563 1,563
Stock option exercises and employee stock plan purchases 360 3 — — 6,059 — — 6,062
Vesting of restricted stock awards 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
Net income — — — — — 28,067 — 28,067
Other comprehensive income — — — — — — ( 774 ) ( 774 )
Stock option exercises and employee stock plan purchases 411 4 — — 8,908 — — 8,912
Vesting of restricted stock awards 845 9 — — ( 9 ) — — —
Shares withheld to cover taxes ( 144 ) ( 1 ) — — ( 7,758 ) — — ( 7,759 )
Repurchase of common stock — — 1,339 ( 75,000 ) — — — ( 75,000 )
Stock-based compensation — — — — 29,262 — — 29,262
Balance, December 31, 2022 68,851 689 1,339 ( 75,000 ) 715,875 ( 193,158 ) ( 1,259 ) 447,147
Net income — — — — — 326,661 — 326,661
Other comprehensive loss — — — — — — 222 222
Stock option exercises and employee stock plan purchases 245 2 — — 5,747 — — 5,749
Vesting of restricted stock awards and units 962 10 — — ( 10 ) — — —
Shares withheld to cover taxes ( 195 ) ( 2 ) — — ( 14,392 ) — — ( 14,394 )
Stock-based compensation — — — — 50,507 — — 50,507
Balance, December 31, 2023 69,863 $ 699 1,339 $ ( 75,000 ) $ 757,727 $ 133,503 $ ( 1,037 ) $ 815,892
The accompanying notes are an integral part of these consolidated financial statements.
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Lantheus Holdings, Inc.
Consolidated Statements of Cash Flows
(in thousands)
Year Ended December 31,
2023 2022 2021
Operating activities
Net income (loss) $ 326,661 $ 28,067 $ ( 71,279 )
Adjustments to reconcile net income (loss) to net cash flows from operating activities:
Depreciation, amortization and accretion 60,043 47,929 42,288
Impairment of long-lived assets 138,050 — 9,729
Asset retirement obligation acceleration — 280 5,259
Gain on interest rate swap termination — ( 5,494 ) —
Amortization of debt related costs 4,300 1,249 676
Changes in fair value of contingent assets and liabilities ( 9,275 ) 34,700 72,400
Charges incurred in connection with acquired IPR&D — 260,000 —
Loss (gain) on extinguishment of debt — 588 ( 889 )
Provision for excess and obsolete inventory 7,914 7,145 4,057
Stock-based compensation 50,507 29,262 15,934
Gain on disposal of assets ( 51,789 ) — ( 15,263 )
Deferred taxes ( 55,632 ) ( 48,016 ) 4,437
Long-term indemnification receivable 3,929 9,554 7,121
Long-term income tax payable and other long-term liabilities ( 3,103 ) ( 12,477 ) ( 7,912 )
Other 4,855 4,059 2,512
Changes in assets and liabilities which provided (used) cash:
Accounts receivable ( 68,637 ) ( 128,460 ) ( 33,102 )
Inventory ( 36,220 ) ( 7,508 ) ( 3,549 )
Other current assets ( 2,418 ) ( 2,440 ) ( 73 )
Other long-term assets — ( 533 ) —
Accounts payable 17,189 301 5,425
Accrued expenses and other liabilities ( 81,114 ) 63,575 16,145
Net cash provided by operating activities 305,260 281,781 53,916
Investing activities
Capital expenditures ( 46,555 ) ( 18,347 ) ( 12,140 )
Proceeds from sale of assets, net 97,839 1,800 15,823
Acquisition of assets ( 45,345 ) ( 260,000 ) —
Net cash provided by (used in) investing activities 5,939 ( 276,547 ) 3,683
Financing activities
Proceeds from issuance of common stock 1,933 1,375 767
Debt issuance costs — ( 95 ) —
Proceeds from issuance of long-term debt, net — 557,750 —
Contingent value rights settlement ( 3,700 ) — —
Payments on long-term debt and other borrowings ( 717 ) ( 175,385 ) ( 43,348 )
Deferred financing costs — ( 2,315 ) —
Proceeds from interest rate swap termination — 5,583 —
Proceeds from stock option exercises 3,816 7,537 5,295
Payments for minimum statutory tax withholding related to net share settlement of equity awards ( 14,394 ) ( 7,759 ) ( 2,046 )
Repurchase of common stock — ( 75,000 ) —
Net cash (used in) provided by financing activities ( 13,062 ) 311,691 ( 39,332 )
Effect of foreign exchange rates on cash and cash equivalents ( 93 ) ( 335 ) ( 310 )
Net increase in cash and cash equivalents and restricted cash 298,044 316,590 17,957
Cash and cash equivalents and restricted cash, beginning of year 417,241 100,651 82,694
Cash and cash equivalents and restricted cash, end of year $ 715,285 $ 417,241 $ 100,651
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Lantheus Holdings, Inc.
Consolidated Statements of Cash Flows (Continued)
(in thousands)
Year Ended December 31,
2023 2022 2021
Reconciliation to amounts within the consolidated balance sheets
Cash and cash equivalents $ 713,656 $ 415,652 $ 98,508
Restricted cash included in other long-term assets 1,629 1,589 2,143
Cash, cash equivalents and restricted cash at end of period $ 715,285 $ 417,241 $ 100,651
Year Ended December 31,
2023 2022 2021
Supplemental disclosure of cash flow information
Cash paid during the period for:
Interest $ 15,387 $ 5,064 $ 6,284
Income taxes, net of refunds of $ 25 , $ 50 and $ 315 , respectively
$ 151,579 $ 54,049 $ 215
Schedule of non-cash investing and financing activities
Additions of property, plant and equipment included in liabilities $ 6,978 $ 2,370 $ 1,262
Right-of-use asset obtained in exchange for operating lease liabilities $ 29,396 $ 11,019 $ 683
The accompanying notes are an integral part of these consolidated financial statements.
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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 LMI is the parent company of Progenics Pharmaceuticals, Inc., a Delaware corporation (“Progenics”), and Cerveau Technologies, Inc. (“Cerveau”). See “Progenics Acquisition” and “Acquisition of Assets”, respectively.
The Company develops, manufactures and commercializes innovative diagnostic and therapeutic products that assist clinicians in the diagnosis and treatment of cancer, heart disease 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 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 hospitals, independent diagnostic testing facilities, 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 prostate cancer diagnostic imaging agent, PYLARIFY (as defined below), are generated in the U.S. through an internal PYLARIFY sales team, as well as a sales team at some of the Company’s positron emission tomography (“PET”) manufacturing facilities (“PMF”) partners. Sales of the Company’s ultrasound enhancing agent, DEFINITY, are generated in the U.S. through an internal DEFINITY sales team. 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 PharmaLogic, Cardinal, RLS, UPPI, and Jubilant Radiopharma. Research revenue is derived from existing partnerships with pharmaceutical companies that use our products and product candidates in clinical trials and includes milestone and dose-related payments. A small portion of the Company’s nuclear imaging product sales in the U.S. are generated through the Company’s internal sales force to hospitals and clinics that maintain their own in-house radiopharmaceutical preparation capabilities.
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 executive offices are located in Bedford, MA, with additional offices in North Billerica, MA, 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 connection with the Progenics Acquisition, Lantheus Holdings issued 26,844,877 shares of Lantheus Holdings common stock and 86,630,633 contingent value rights (each a “CVR”) tied to the financial performance of PYLARIFY to former Progenics stockholders and option holders. Each CVR entitled its holder to receive a pro rata share of aggregate cash payments equal to 40 % of United States (“U.S.”) net sales generated by PYLARIFY in 2022 and 2023 in excess of $ 100.0 million and $ 150.0 million, respectively. 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, was capped at 19.9 % of the total consideration the Company paid in the Progenics Acquisition. Based on the Company’s 2022 PYLARIFY net sales, the Company determined that the aggregate payment obligation under the CVRs was $ 99.6 million, which was the maximum amount payable. The Company paid out this amount in May 2023 in full satisfaction of the CVRs.
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.
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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 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 doubtful accounts is necessary. Allowance for doubtful accounts has been immaterial for all years presented.
Income Taxes
The Company accounts for income taxes using an asset and liability approach. Income tax (benefit) expense 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.
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
The Company computes earnings per share using the two-class method. 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. The Company’s potentially dilutive shares, which could include shares issuable upon conversion of the 2.625 % Convertible Senior Notes due 2027 (the “Notes”), are considered to be common stock equivalents and are only included in the calculation of diluted net income per share when their effect is dilutive. The Company has the option to settle the Notes through cash settlement or a combination of cash and share settlement provided that the principal is settled in cash and the conversion spread is settled in cash or shares as elected by the Company. The Company applies the if-converted method for diluted earnings in order to reflect the conversion spread. 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.
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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, 2023 and 2022, 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 hospitals, independent diagnostic testing facilities, and radiopharmacies.
As of December 31, 2023 and 2022, 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, 2023, 2022 and 2021.
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 currently relies on JHS as its significant manufacturer of DEFINITY and its sole source manufacturer of NEUROLITE, CARDIOLITE and evacuation vials for TechneLite. The Company relies on Samsung Biologics Co., Ltd. (“SBL”) as its sole source manufacturer of DEFINITY RT. The Company has Mo-99 supply agreements with IRE of Belgium, running through December 31, 2024, with auto-renewal provisions and terminable upon notice of non-renewal, and with NTP and its subcontractor ANSTO, running through December 31, 2024.
The following table sets forth revenues for each of the Company’s products representing 10% or more of revenues:
Year Ended
December 31,
2023 2022 2021
PYLARIFY
65.7 % 56.4 % 10.2 %
DEFINITY 21.6 % 26.2 % 54.7 %
TechneLite 6.7 % 9.5 % 21.5 %
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.
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. The Company had no inventory pending regulatory approval as of December 31, 2023.
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 are computed on a straight-line basis over the estimated useful lives of the related assets and recorded
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in 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 and equipment 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.
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 it 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 performed a qualitative assessment and did no t recognize any goodwill impairment charges during the years ended December 31, 2023, 2022 or 2021.
Intangible and Long-Lived Assets
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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.
Costs of IPR&D intangible assets acquired as part of an asset acquisition that have no alternative future use are expensed when incurred. Milestone payments made after regulatory approval are capitalized as an intangible asset and amortized over an estimated useful life of the product. Cash payments related to acquired IPR&D intangible assets are reflected as an investing cash flow in the Company's consolidated statement of cash flows.
The Company’s IPR&D intangible assets includes 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 intangible assets 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 intangible 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 10, “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.
Convertible Notes
The Company evaluates convertible notes to determine if those contracts or embedded components of those contracts qualify as derivatives to be separately accounted for. The change in fair value of any separately recognized derivative is recorded in the consolidated statement of operations as other income or expense. Upon conversion, exercise or cancellation of a derivative instrument, the instrument is marked to fair value at the date of conversion, exercise or cancellation.
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 Company’s long-term debt has triggering events that would impact the fair value of the instruments. The Company determined that no triggering event has occurred during the years ended December 31, 2023 and December 31, 2022. As of December 31, 2023, the fair value of the Company’s convertible debt was estimated to be approximately $ 644.3 million based on external pricing data, including quoted market prices of these instruments and was classified as a Level 1 measurement within the fair value hierarchy. As of December 31, 2022, the carrying value of the Company’s convertible debt approximated fair value and was classified as a Level 1 measurement within the fair value hierarchy. The fair value See Note 4, “Fair Value of Financial Instruments”.
Contingent Consideration Liabilities
The estimated fair value of contingent consideration liabilities are 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 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.
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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.
The Company's acquisitions accounted for as asset acquisitions may also include contingent consideration payments to be made for sales-based milestones, development and regulatory milestones. The Company assesses whether such contingent consideration meets the definition of a derivative. Contingent consideration payments in an asset acquisition not required to be accounted for as derivatives are recognized when the contingency is resolved, and the consideration is paid or becomes payable. Contingent consideration payments required to be accounted for as derivatives are recorded at fair value on the date of the acquisition and are subsequently remeasured to fair value at each reporting date. Upon recognition of the contingent consideration payment, the amount is included in the cost of the acquired asset or group of assets.
Derivative Instruments
The Company has used 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, 2023, 2022 and 2021, the Company incurred $ 26.0 million, $ 26.0 million and $ 17.5 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 loss (income) 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.
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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).
Other Loss (Income)
Other loss (income) consisted of the following:
Year Ended
December 31,
(in thousands) 2023 2022 2021
Foreign currency losses $ 21 $ 256 $ 274
Tax indemnification expense, net 4,943 9,554 7,121
Interest income ( 19,638 ) ( 2,613 ) ( 45 )
Interest rate swap termination — ( 5,494 ) —
Gain on sale of RELISTOR licensed intangible asset associated with net sales royalties ( 51,789 )
Other 143 — —
Total other (income) loss $ ( 66,320 ) $ 1,703 $ 7,350
Comprehensive Income (Loss)
Comprehensive income (loss) consists of net income (loss) and other gains and losses affecting stockholders’ equity that, under U.S. GAAP, are excluded from net income. For the Company, other comprehensive income (loss) consists of foreign currency translation gains and losses as well as realized and unrealized gains and losses on cash flow hedges related to the Company’s interest rate swaps. The accumulated other comprehensive income (loss) balance consists entirely of foreign currency translation gains and losses and realized and unrealized gains and losses on outstanding 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 campus and its Somerset, New Jersey 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, 2023 and 2022, 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, 2023 and 2022.
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Self-Insurance Reserves
The Company’s consolidated balance sheets at December 31, 2023 and 2022 include $ 1.0 million and $ 0.9 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).
Recent Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. The guidance in this update is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024. The Company is currently in the process of evaluating the effects of this pronouncement on our related disclosures.
In December 2023, the FASB also issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires enhanced income tax disclosures, including specific categories and disaggregation of information in the effective tax rate reconciliation, disaggregated information related to income taxes paid, income or loss from continuing operations before income tax expense or benefit, and income tax expense or benefit from continuing operations. The requirements of the ASU are effective for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently in the process of evaluating the impact of this pronouncement on our related disclosures.
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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) 2023 2022 2021
Product revenue, net (1)
$ 1,263,068 $ 887,038 $ 400,356
License and royalty revenues (2)
33,361 48,023 24,852
Total revenues $ 1,296,429 $ 935,061 $ 425,208
______________________________
(1) The Company’s product revenue includes PYLARIFY and DEFINITY, among other products. This category represents the delivery of physical goods. The Company applies the same revenue recognition policies and judgments for all of its principal products.
(2) The Company recognized $ 24.0 million license revenue in the first quarter of 2022 related to an agreement with Novartis Pharma AG.
The Company classifies its revenues into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. Radiopharmaceutical Oncology includes PYLARIFY and AZEDRA. In 2023, the Company announced its decision to discontinue the production and promotion of AZEDRA and it does not expect AZEDRA to contribute to the business after the first quarter of 2024. Precision Diagnostics includes DEFINITY, TechneLite and other diagnostic imaging products. Strategic Partnerships and Other Revenue includes strategic partnerships and other arrangements related to other products of the Company, including our royalty revenue from our license of RELISTOR. On August 2, 2023, the Company sold the RELISTOR royalty asset under its license agreement with Bausch; the Company retained the rights to future sales-based milestone payments. During the fourth quarter of 2023, the Company earned a $ 15.0 million sales-based milestone payment.
On January 31, 2022, the Company entered into a global settlement agreement with Novartis Pharma AG (“Novartis”), Advanced Accelerator Applications USA, Inc., Endocyte, Inc. and their affiliates (the “Novartis Agreement”) to settle certain disputes between the parties. Under the Novartis Agreement, Novartis agreed to make a lump sum payment to the Company, as well as to reimburse the Company for certain fees and expenses in connection with certain German litigation, and the Company agreed to license certain intellectual property to Novartis. In addition, the Company agreed to supply PYLARIFY for clinical purposes at an arms-length value which will be recorded revenue in the future as product is provided. In accordance with the Company's ASC 606, Revenue from Contracts with Customers , assessment, Novartis is considered to be a customer. The Company determined that the $ 24.0 million constituted a single element which was satisfied on the date of the execution of the Novartis Agreement. The Company determined that the license of intellectual property carried a fair value of $ 24.0 million. As such, the Company assigned the value to the fair value of the license, which constitutes the entire transaction price and does not require further allocation. The Company determined that the $ 24.0 million represented the point at which the licensee was able to use and benefit from the license and recognized revenue when the license was granted to Novartis upon execution of the Novartis Agreement. The Company recognized the $ 24.0 million fee as revenue on its consolidated statement of operations for the quarter ended March 31, 2022. The Company received the $ 24.0 million payment in April 2022.
Revenue by product category on a net basis is as follows:
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Year Ended December 31,
(in thousands) 2023 2022 2021
PYLARIFY $ 851,303 $ 527,405 $ 43,414
Other radiopharmaceutical oncology 3,130 4,102 5,473
Total radiopharmaceutical oncology 854,433 531,507 48,887
DEFINITY 279,768 244,993 232,759
TechneLite 87,370 88,864 91,293
Other precision diagnostics 22,980 22,825 26,973
Total precision diagnostics 390,118 356,682 351,025
Strategic Partnerships and other revenue 51,878 46,872 25,296
Total revenues $ 1,296,429 $ 935,061 $ 425,208
Product Revenue, Net
The Company sells its products principally to hospitals, independent diagnostic testing facilities, 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.
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
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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.
An analysis of the amount of, and change in, reserves is summarized as follows:
(in thousands) Rebates and
Allowances
Balance, January 1, 2022 $ 10,977
Provision related to current period revenues 26,683
Adjustments relating to prior period revenues 70
Payments or credits made during the period ( 24,331 )
Balance, December 31, 2022 13,399
Provision related to current period revenues 32,308
Adjustments relating to prior period revenues ( 453 )
Payments or credits made during the period ( 29,184 )
Balance, December 31, 2023 $ 16,070
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.
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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, 2023, the variable consideration for the milestone payments is constrained and is excluded from contract price until the milestone is achieved by the customer.
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).
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) 2023 2022
Amounts included in the contract liability at the beginning of the period $ 682 $ 244
The Company did not record any revenue related to performance obligations satisfied (or partially satisfied) in previous periods during the years ended December 31, 2023 and 2022.
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.
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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 13, “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.
The tables below present information about the Company’s assets and liabilities measured at fair value on a recurring basis:
December 31, 2023
(in thousands) Total Fair
Value Level 1 Level 2 Level 3
Assets:
Money market funds $ 574,131 $ 574,131 $ — $ —
Total assets $ 574,131 $ 574,131 $ — $ —
Liabilities:
Contingent consideration liabilities $ 2,700 $ — $ — $ 2,700
Total liabilities $ 2,700 $ — $ — $ 2,700
December 31, 2022
(in thousands) Total Fair
Value Level 1 Level 2 Level 3
Assets:
Money market funds $ 342,646 $ 342,646 $ — $ —
Total assets $ 342,646 $ 342,646 $ — $ —
Liabilities:
Contingent consideration liabilities $ 111,600 $ — $ — $ 111,600
Total liabilities $ 111,600 $ — $ — $ 111,600
During the years ended December 31, 2023 and 2022, there were no transfers into or out of Level 3. On December 2, 2022, the Company voluntarily terminated the interest rate swap contracts in connection with the refinancing of debt.
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. (“CytoDyn”) 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
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pertaining to regulatory events and sales targets. During the fourth quarter of 2022, the Company reduced the probability to zero as CytoDyn withdrew their regulatory application. 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 entitled 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, subject to a maximum cap. Refer to Note 1, “Basis of Presentation” for further details on the CVRs. The Company paid out the maximum amount payable under the CVRs from available cash in May 2023 in full satisfaction of the CVR obligation.
The Company also 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 (also known as 131 I-MIP-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 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 with respect to 1095 and 1404 are the probabilities of achieving regulatory approval of those 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 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 liabilities using Level 3 inputs as of December 31, 2023.
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Fair Value as of Assumptions
(in thousands) December 31, 2023 December 31, 2022 Valuation Technique Unobservable Input December 31, 2023 December 31, 2022
Contingent consideration liability:
Net sales targets – PYLARIFY (CVRs) N/A $ 99,700 Probability adjusted discounted cash flow model Period of expected milestone achievement and sales targets N/A 2022 – 2023
Probability of success N/A 100 %
1095 commercialization milestone 1,800 1,700 Probability adjusted discounted cash flow model
Period of expected milestone achievement 2026 2026
Probability of success 40 % 40 %
Discount rate 4.1 % 3.8 %
Net sales targets – AZEDRA and 1095 900 10,200 Monte Carlo simulation
Probability of success and sales targets 0 % - 40 %
20 % - 100 %
Discount rate 15 %
16 % - 17 %
Total $ 2,700 $ 111,600
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,
2023 2022 2023 2022
Fair value, beginning of period $ — $ 9,300 $ 111,600 $ 86,200
Changes in fair value included in net income (loss) — ( 9,300 ) ( 9,275 ) 25,400
Cash Payments — — ( 99,625 ) —
Fair value, end of period $ — $ — $ 2,700 $ 111,600
The change in fair value of the contingent financial asset and contingent financial liabilities, including the CVRs, resulted in a general and administrative expense of $ 9.3 million for the year ended December 31, 2023 and was primarily due to changes in revenue forecasts, changes in market conditions, an increase in discount rates (excluding the CVRs) and the passage of time. The Company made the applicable cash payment related to the CVRs in May 2023.
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5. Income Taxes
The components of income (loss) before provision (benefit) for income taxes consists of the following:
Year Ended
December 31,
(in thousands) 2023 2022 2021
U.S. $ 410,326 $ 29,012 $ ( 76,389 )
International 617 ( 2,293 ) 1,351
Income (loss) before income taxes $ 410,943 $ 26,719 $ ( 75,038 )
The Company’s provision (benefit) for income taxes consists of the following:
Year Ended
December 31,
(in thousands) 2023 2022 2021
Current
Federal $ 110,108 $ 42,532 $ —
State 29,806 4,302 ( 8,166 )
International — ( 166 ) ( 30 )
139,914 46,668 ( 8,196 )
Deferred
Federal ( 45,252 ) ( 39,920 ) 1,048
State ( 10,739 ) ( 8,315 ) 3,058
International 359 219 331
( 55,632 ) ( 48,016 ) 4,437
Income tax expense (benefit) $ 84,282 $ ( 1,348 ) $ ( 3,759 )
The reconciliation of income taxes at the U.S. federal statutory rate to the income tax expense (benefit) is as follows:
Year Ended
December 31,
(in thousands) 2023 2022 2021
U.S. statutory rate $ 86,298 $ 5,611 $ ( 15,758 )
Permanent items 1,042 2,309 1,764
Sale of RELISTOR licensed intangible asset associated with net sales royalties ( 10,817 ) — —
Section 162(m) 307 247 1,028
Uncertain tax positions ( 5,045 ) ( 12,629 ) ( 8,952 )
Tax credits ( 2,118 ) ( 4,085 ) ( 990 )
State and local taxes 18,726 67 656
Impact on deferred taxes of change in tax rate ( 330 ) 4,169 3,049
Changes in fair value of contingent assets and liabilities ( 1,948 ) 5,422 15,015
Foreign tax rate differential 128 68 23
Valuation allowance ( 4 ) ( 30 ) ( 400 )
Stock compensation ( 3,941 ) ( 4,612 ) ( 1,164 )
Change in indemnification deferred tax asset 1,240 2,343 1,786
Other 744 ( 228 ) 184
Income tax expense (benefit) $ 84,282 $ ( 1,348 ) $ ( 3,759 )
The components of deferred income tax assets (liabilities) are as follows:
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December 31,
(in thousands) 2023 2022
Deferred Tax Assets
Federal benefit of state taxes payable $ 263 $ 1,739
Reserves, accruals and other 18,923 31,532
Inventory obsolescence — 919
Capitalized research and development 17,142 79,946
Stock compensation 9,266 —
Intangible assets 25,214 —
Net operating loss carryforwards 80,184 88,014
Lease liability 14,365 —
Deferred tax assets 165,357 202,150
Deferred Tax Liabilities
Reserves, accruals and other — ( 5,354 )
Right-of-use asset ( 11,543 ) —
Intangible assets — ( 80,770 )
Amortization of intangibles other than goodwill — ( 385 )
Depreciation — ( 1,469 )
Deferred tax liability ( 11,543 ) ( 87,978 )
Less: valuation allowance ( 3,616 ) ( 3,525 )
$ 150,198 $ 110,647
Recorded in the accompanying consolidated balance sheets as:
Noncurrent deferred tax assets, net $ 150,198 $ 110,647
The Tax Cuts and Jobs Act (the “Act”) was enacted on December 22, 2017. Under the Act, research and experimental expenditures incurred for tax years beginning after December 31, 2021, must be capitalized and amortized ratably over five or fifteen years for tax purposes, depending on where the research activities are conducted. If the requirement to capitalize Section 174 expenditures is not modified, it may impact our cash tax liability in future years. The increase in worldwide net deferred tax assets is primarily due to the tax capitalization of the Company’s current year research and development expenses that are not currently deductible in 2023 and the decrease in deferred tax liabilities related to the AZEDRA and RELISTOR royalty intangible assets, partially offset by utilization of net operating losses.
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. As of December 31, 2023 and 2022, the Company maintains a valuation allowance of $ 3.6 million and $ 3.5 million, respectively, primarily related to net deferred tax assets of certain of its foreign subsidiaries.
Utilization of net operating loss carryforwards and research and development credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that could occur in the future in accordance with Section 382 of the Internal Revenue Code of 1986 (“IRC Section 382”) and with Section 383 of the Internal Revenue Code of 1986, as well as similar state provisions. These ownership changes may limit the amount of net operating loss carryforwards and research and development credit carryforwards that can be utilized annually to offset future taxable income and taxes, respectively. In general, an ownership change, as defined by IRC Section 382, results from transactions which impact the ownership of certain stockholders or public groups in the stock of a corporation by more than 50 percentage points over a three-year period.
At December 31, 2023, the Company had U.S. federal net operating loss carryforwards of approximately $ 297.6 million, $ 157.9 million of which will expire between 2027 and 2037, and $ 139.6 million of which can be carried forward indefinitely. The Company’s state net operating losses are $ 12.5 million on a tax-effected basis, which will expire between 2024 and 2040. The Company has state research credit carryforwards of $ 2.1 million, which will expire between 2026 and 2038. The Company has state investment tax credit carryforwards of $ 0.8 million which have no expiration date.
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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 jurisdiction’s statutes of limitation, and in the case of Sweden, up to six years after the end of the financial year.
A reconciliation of the Company’s changes in uncertain tax positions for 2023 and 2022 is as follows:
(in thousands) Amount
Balance of uncertain tax positions as of January 1, 2021 $ 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
Additions related to current year tax positions —
Reductions related to prior year tax positions ( 1,180 )
Settlements ( 306 )
Lapse of statute of limitations ( 692 )
Balance of uncertain tax positions as of December 31, 2022 1,480
Additions related to current year tax positions 3,749
Reductions related to prior year tax positions ( 688 )
Settlements ( 442 )
Lapse of statute of limitations —
Balance of uncertain tax positions as of December 31, 2023 $ 4,099
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 an indemnification agreement with BMS for any payments made to settle those uncertain tax positions with the taxing authorities.
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. Included in other (income) loss for the years ended December 31, 2023, 2022 and 2021, is tax indemnification expense (income), net of $ 4.9 million, $ 9.6 million and $ 7.1 million, respectively.
As of December 31, 2023 and 2022, total liabilities for uncertain tax positions including interest and penalties were $ 5.4 million and $ 8.3 million, respectively, consisting of uncertain tax positions of $ 4.1 million and $ 1.5 million, respectively, interest accruals of $ 1.3 million and $ 6.4 million, respectively, and no penalty accruals as of December 31, 2023 and $ 0.4 million of penalty accruals as of December 31, 2022. The increase in uncertain tax positions during the year ended December 31, 2023 was primarily related to certain acquired tax attributes. As of December 31, 2023, $ 1.3 million, $ 3.2 million, and $ 0.9 million of these liabilities were recorded in current liabilities, other long-term liabilities, and as a reduction of deferred tax assets, respectively. As of December 31, 2022 these liabilities were included in other long-term liabilities. Included in the 2023, 2022 and 2021 tax provisions are benefits of $ 5.0 million, $ 12.6 million and $ 9.0 million, respectively, relating to reversals of uncertain tax positions recognized upon settlements, effective settlements, or lapses of relevant statutes of limitation, partially offset by interest accruals.
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6. Inventory
Inventory consisted of the following:
December 31,
(in thousands) 2023 2022
Raw materials $ 31,259 $ 19,987
Work in process 13,807 8,234
Finished goods 18,963 7,254
Total inventory $ 64,029 $ 35,475
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. The Company has no inventory pending regulatory approval as of December 31, 2023.
7. Property, Plant and Equipment, Net
Property, plant and equipment, net, consisted of the following:
December 31,
(in thousands) 2023 2022
Land $ 9,480 $ 13,450
Buildings 73,441 76,329
Machinery, equipment and fixtures 102,576 92,604
Computer software 27,259 25,864
Construction in progress 40,964 14,047
253,720 222,294
Less: accumulated depreciation and amortization ( 107,023 ) ( 100,128 )
Total property, plant and equipment, net $ 146,697 $ 122,166
Depreciation and amortization expense related to property, plant & equipment, net, was $ 13.2 million, $ 13.7 million and $ 13.2 million for the years ended December 31, 2023, 2022 and 2021, 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 16, “Leases” for further details.
During the three months ended June 30, 2023, as a result of a decline in expected future cash flows related to a certain asset group, the Company determined certain impairment triggers had occurred. The Company reviewed revised undiscounted cash flows that were estimated to be generated by the asset group as of June 30, 2023. Based on the undiscounted cash flow analysis, the Company determined that the asset group 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 their discounted cash flows. The carrying value exceeded the fair value and as a result, the Company recorded a noncash impairment of $ 6.0 million for the six months ended June 30, 2023 in cost of goods sold in the consolidated statements of operations.
Long-Lived Assets Held for Sale
During the first quarter of 2023, the Company committed to a plan to sell a portion of its land and buildings associated with its Billerica, Massachusetts campus. Effective March 16, 2023, the Company entered into a purchase and sale agreement (the “P&S”) with a prospective buyer. The assets were classified as held for sale and comprised entirely of property, plant and equipment, net. The Company determined that the fair value of the net assets being sold exceeded the carrying value as of September 30, 2023. The purchase price for the campus sale is $ 10.0 million in cash. The transaction is expected to close in the second or third quarter of 2024.
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8. 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.
The Company determined that this sale of certain net assets did not constitute a strategic shift that had a major effect on the Company’s operations or financial results. As a result, this transaction was not classified as discontinued operations in the Company’s accompanying consolidated financial statements.
The sale resulted in a pre-tax book gain of $ 15.3 million, which was recorded within operating income (loss) in the consolidated statements of operations for the year ended December 31, 2021.
9. 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, 2023, the liability is measured at the present value of the obligation expected to be incurred, of approximately $ 25.1 million.
The following table provides a summary of the changes in the Company’s asset retirement obligations:
(in thousands) Amount
Balance, January 1, 2022 $ 20,833
Change in useful life estimate 280
Accretion expense 1,430
Balance, December 31, 2022 22,543
Accretion expense 373
Balance, December 31, 2023 $ 22,916
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, respectively, upon closure. The Company has provided this financial assurance in the form of a $ 30.3 million surety bond.
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10. Intangibles, Net and Goodwill
Intangibles, net, consisted of the following:
December 31, 2023
(in thousands) Useful Lives (in years) Amortization
Method Cost Accumulated Amortization Net
Trademarks 15 – 25
Straight-Line $ 13,540 $ ( 12,216 ) $ 1,324
Customer relationships 15 – 25
Accelerated 157,995 ( 117,574 ) 40,421
Currently marketed product 9 – 15
Straight-Line 132,800 ( 38,277 ) 94,523
Licenses 11 – 16
Straight-Line 22,233 ( 7,972 ) 14,261
Developed technology 9 Straight-Line 2,400 ( 944 ) 1,456
Total $ 328,968 $ ( 176,983 ) $ 151,985
December 31, 2022
(in thousands) Useful Lives (in years) Amortization
Method Cost Accumulated Amortization Net
Trademarks 15 – 25
Straight-Line $ 13,540 $ ( 12,061 ) $ 1,479
Customer relationships 15 – 25
Accelerated 96,681 ( 95,009 ) 1,672
Currently marketed product 9 – 15
Straight-Line 275,700 ( 47,628 ) 228,072
Licenses 11 – 16
Straight-Line 85,800 ( 19,101 ) 66,699
Developed technology 9 Straight-Line 2,400 ( 677 ) 1,723
IPR&D N/A N/A 15,640 — 15,640
Total $ 489,761 $ ( 174,476 ) $ 315,285
The Company recorded amortization expense for its intangible assets of $ 46.4 million, $ 33.2 million and $ 27.5 million for the years ended December 31, 2023, 2022 and 2021, 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.
On August 2, 2023, the Company sold the right to its RELISTOR royalty asset under its license agreement with Bausch; the Company retained the rights to future sales-based milestone payments. The Company received an initial payment of approximately $ 98.0 million in connection with the sale and has the right to receive an additional payment from the buyer of $ 5.0 million if worldwide net sales of RELISTOR in 2025 exceed a specified threshold. The additional payment would be recognized upon achievement of the specified threshold. Decreases of $ 63.6 million of license assets and $ 17.5 million of associated accumulated amortization, as well as a gain of $ 51.8 million were recorded as a result of the sale. During the fourth quarter of 2023, the Company earned a $ 15.0 million sales-based milestone payment.
In March 2023, the Company stopped all development activities in relation to a future indication associated with AZEDRA, which was classified as an IPR&D intangible asset. The asset group, which consisted of the IPR&D asset and a currently marketed product (the “AZEDRA intangible asset group”), was assessed for impairment. The Company considered several factors in estimating the future projections of revenues and cash flows of the AZEDRA intangible asset group as part of the impairment testing. The Company concluded that the carrying amount exceeded the fair value of the AZEDRA intangible asset group, which had no value. The Company recorded a non-cash impairment charge of $ 15.6 million in research and development expenses relating to the IPR&D asset and $ 116.4 million in cost of goods sold relating to the currently marketed indication of AZEDRA in the consolidated statement of operations for the year ended December 31, 2023.
On August 15, 2023, the Company announced that it had made the decision to discontinue the production and promotion of AZEDRA and would be winding down its Somerset, New Jersey manufacturing site. The Company will continue manufacturing AZEDRA into the first quarter of 2024, to the extent feasible, with the goal of providing doses of AZEDRA to current patients so they can complete their treatment regimen. See Note 7, “Property, Plant and Equipment, Net” for impairment analysis.
In February 2023, the Company entered into an agreement with the stockholders of Cerveau to purchase all of the outstanding capital stock of Cerveau for approximately $ 35.3 million. In May 2023, upon successful completion of a technology transfer, the Company paid $ 10.0 million to the selling stockholders of Cerveau. This additional contingent payment was capitalized as part of the
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asset cost and increased the Company’s customer relationship intangible assets. See Note 21, “Acquisition of Assets” for further discussion of the Cerveau acquisition.
The below table summarizes the estimated aggregate amortization expense expected to be recognized on the above intangible assets:
(in thousands) Amount
2024 $ 39,726
2025 24,409
2026 25,206
2027 19,680
2028 16,195
2029 and thereafter 26,769
Total $ 151,985
11. 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) 2023 2022
Compensation and benefits $ 36,331 $ 30,425
Freight, distribution and operations 67,529 49,067
Accrued rebates, discounts and chargebacks 16,070 13,399
Accrued professional fees 10,244 8,668
Other 15,164 25,525
Total accrued expenses and other liabilities $ 145,338 $ 127,084
Operating lease liabilities (Note 16) $ 54,453 $ 25,442
Long-term contingent liability (Note 4) 2,700 11,900
Other long-term liabilities 6,168 8,813
Total other long-term liabilities $ 63,321 $ 46,155
12. Long-Term Debt, Net, and Other Borrowings
As of December 31, 2023, the Company’s maturities of principal obligations under its long-term debt and other borrowings are as follows:
(in thousands) Amount
2024 $ —
2025 —
2026 —
2027 575,000
2028 —
Total principal outstanding 575,000
Unamortized debt issuance costs ( 13,955 )
Finance lease liabilities 1,448
Total 562,493
Less: current portion ( 823 )
Total long-term debt, net, and other borrowings $ 561,670
In December 2022, the Company refinanced its existing credit facility, consisting of (i) a $ 200.0 million five-year term loan facility (the “2019 Term Facility”) and (ii) a $ 200.0 million five-year revolving credit facility (the “2019 Revolving Facility” and, together with the 2019 Term Facility, the “2019 Facility”), with a new $ 100.0 million delayed draw term loan facility (the “2022 Term
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Facility” and, the loans thereunder, the “Term Loans”) and a new $ 350.0 million five-year revolving credit facility (the “2022 Revolving Facility” and, together with the 2022 Term Facility, the “2022 Facility”).
The Company used approximately $ 7.8 million of cash on hand to primarily repay the principal amount of the loans outstanding related to the 2019 Facility through the nine months ended September 30, 2022. In addition, in December 2022, the Company used approximately $ 167.6 million of cash on hand to repay in full the aggregate remaining principal amount of the loans outstanding under the 2019 Facility and to pay related interest, transaction fees and expenses.
The Company paid off the 2019 Term Facility using available cash and did not utilize another term loan to fund the payoff. While the 2022 Term Facility allowed for a delayed draw term loan, the loan was not drawn upon. The Company recorded a loss on extinguishment of debt of $ 0.6 million related to the write-off of unamortized debt issuance costs and debt discounts associated with the 2019 Term Facility. In addition, the Company incurred and capitalized $ 2.7 million of new deferred financing costs related to the refinancing.
2022 Revolving Facility
Under the terms of the 2022 Revolving Facility, the lenders are committed to extending credit to the Company from time to time until December 2, 2027 consisting of revolving loans (the “Revolving Loans”) in an aggregate principal amount not to exceed $ 350.0 million (the “Revolving Commitment”) at any time, including a $ 20.0 million sub-facility for the issuance of letters of credit (the “Letters of Credit”) and a $ 10.0 million sub-facility for swingline loans (the “Swingline Loans”). The Letters of Credit, Swingline Loans and the Revolving Loans, if used, are expected to be used for working capital and for other general corporate purposes.
The Revolving Loans bear interest, with pricing based from time to time at the Company’s election, at (i) the secured overnight financing rate as published by the Federal Reserve Bank of New York on its website plus an applicable margin that ranges from 1.50 % to 2.50 % based on the Company’s total net leverage ratio or (ii) the alternative base rate plus an applicable margin that ranges from 0.50 % to 1.50 % based on the Company’s total net leverage ratio. The 2022 Revolving Facility also includes an unused commitment fee at a rate ranging from 0.15 % to 0.35 % per annum based on the Company’s total net leverage ratio.
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, Letters of Credit and Swingline Loans exceeds the total Revolving Commitment, the Company must prepay the Revolving Loans in an amount equal to such excess. The Company is not required to make mandatory prepayments under the 2022 Revolving Facility. As of December 31, 2023, there were no outstanding borrowings under the 2022 Revolving Facility.
The Company has the right to request an increase to the Revolving Commitment in an aggregate principal amount of up to the sum of $ 335.0 million or consolidated EBITDA for the four consecutive fiscal quarters most recently ended, plus additional amounts in certain circumstances (collectively, the “Incremental Cap”), minus certain incremental term loans made pursuant to specified incremental term loan commitments (“Incremental Term Loans”). The Company has the right to request Incremental Term Loans in an aggregate principal amount of up to the Incremental Cap less any incremental increases to the Revolving Commitment. Proceeds of Incremental Term Loans may be used for working capital and for other general corporate purposes and will bear interest at rates agreed between the Company and the lenders providing the Incremental Term Loans.
2022 Facility Covenants
The 2022 Facility contains a number of affirmative, negative and reporting covenants, as well as financial maintenance covenants pursuant to which the Company is required 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 December 31, 2022, must be at least 3.00 to 1.00. The maximum total net leverage ratio permitted by the financial covenant, commencing with the fiscal quarter ending March 31, 2024, is 3.50 to 1.00.
The 2022 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 will have the right to declare the loans and other obligations outstanding under the 2022 Facility immediately due and payable and all commitments immediately terminated.
The 2022 Facility is guaranteed by Holdings, and certain subsidiaries of LMI, including Progenics and Lantheus MI Real Estate, LLC, and obligations under the 2022 Facility are generally secured by first priority liens over substantially all of the assets of each of
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LMI, Holdings, and certain subsidiaries of LMI, including Progenics and Lantheus MI Real Estate, LLC (subject to customary exclusions set forth in the transaction documents) owned as of December 2, 2022 or thereafter acquired.
Convertible Notes
On December 8, 2022, the Company issued $ 575.0 million in aggregate principal amount of 2.625 % Convertible Senior Notes due 2027 (the “Notes”), which includes $ 75.0 million in aggregate principal amount of Notes sold pursuant to the full exercise of the initial purchasers’ option to purchase additional Notes. The Notes were issued under an indenture, dated as of December 8, 2022 (the “Indenture”), among the Company, LMI (the “Guarantor”), a wholly owned subsidiary of the Company, as Guarantor, and U.S. Bank Trust Company, National Association, as Trustee. The net proceeds from the issuance of the Notes were approximately $ 557.8 million after deducting the initial purchasers’ discounts and offering expenses payable by the Company.
The Notes are senior unsecured obligations of the Company. The Notes are fully and unconditionally guaranteed on a senior unsecured basis by the Guarantor. The Notes bear interest at a rate of 2.625 % per year, payable semi-annually in arrears on June 15 and December 15 of each year, beginning on June 15, 2023, and will mature on December 15, 2027 unless earlier redeemed, repurchased or converted in accordance with their terms. The initial conversion rate for the Notes is 12.5291 shares of the Company’s common stock per $1,000 in principal amount of Notes (which is equivalent to an initial conversion price of approximately $ 79.81 per share of the Company’s common stock, representing an initial conversion premium of approximately 42.5 % above the closing price of $ 56.01 per share of the Company’s common stock on December 5, 2022). In no event shall the conversation rate per $1,000 in principal amount of notes exceed 17.8539 shares of the Company’s common stock. Prior to the close of business on the business day immediately preceding September 15, 2027, the Notes may be converted at the option of the holders only upon occurrence of specified events and during certain periods, and thereafter until the close of business on the business day immediately preceding the maturity date, the Notes may be converted at any time. The Company will satisfy any conversion by paying cash up to the aggregate principal amount of the Notes to be converted and by paying or delivering, as the case may be, cash, shares of the Company’s common stock, or a combination of cash and shares of the Company’s common stock, at its election, in respect of the remainder, if any, of its conversion obligation in excess of the aggregate principal amount of the Notes being converted. The Company may redeem for cash all or any portion of the Notes, at its option, on or after December 22, 2025 if the closing sale price per share of the Company’s common stock exceeds 130 % of the conversion price of the Notes for a specified period of time. The redemption price will be equal to 100 % of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date.
The Company evaluated the Notes upon completion of the sale and concluded on the following features:
• Conversion Feature: The Company determined that the conversion feature qualifies for the classification of equity. As a result, the conversion feature should not be bifurcated as a derivative instrument and the Notes were accounted for as a single liability.
• Redemption Features: The redemption features were reviewed within the Notes and the Company determined that the redemption features are closely related to the Notes and as such should not be separately accounted for as a bifurcated derivative instrument.
• Additional Interest Features: The Notes may result in additional interest if the Company fails to timely file any document or report that the Company is required to file with the SEC pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. The Company will pay additional interest on the notes at a rate equal to 0.25 % to 0.50 % per annum based on the principal amount of notes outstanding for each day the Company failure to file has occurred or the notes are not otherwise freely tradable. Further, if the notes are assigned a restricted CUSIP number or the notes are not otherwise freely tradable pursuant to Rule 144 under the Securities Act by holders other than our affiliates or holders that were our affiliates at any time during the three months immediately preceding as of the 385 th day after the last date of original issuance of the notes offered hereby, the Company will pay additional interest on the notes at a rate equal to (i) 0.25 % to 0.50 % per annum based on the principal amount of notes outstanding for each day until the restrictive legend has been removed from the notes, the notes are assigned an unrestricted CUSIP and the notes are freely tradable. The Company concluded that the interest feature is unrelated to the credit risk and should be bifurcated from the Notes, however, the Company assessed the probabilities of triggering events occurring under these features and does not expect to trigger the aforementioned events. These events will continue to be monitored to determine whether the interest feature will be bifurcated if it has value.
As of December 31, 2023, the carrying value of the Notes was $ 575.0 million, had an unamortized discount of zero , and the fair value of the liability was $ 575.0 million. The Company recorded interest expense of approximately $ 15.1 million related to the Notes for the year ended December 31, 2023.
13. Derivative Instruments
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The Company has used 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 was approximately 0.82 %. This agreement involved 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 were 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.
On December 2, 2022, the Company voluntarily terminated the interest rate swap contracts in connection with the refinancing of debt. Upon termination, the Company received approximately $ 5.6 million in cash and the remaining balance of approximately $ 5.5 million in accumulated other comprehensive income (loss) related to the interest rate swap contracts were reclassified into earnings.
14. Accumulated Other Comprehensive Loss
The components of Accumulated Other Comprehensive Loss, net of tax of zero and zero for the year ended December 31, 2023 and 2022, respectively, consisted of the following:
(in thousands) Foreign currency translation Unrealized loss on cash flow hedges Accumulated other comprehensive loss
Balance at January 1, 2023 $ ( 1,259 ) $ — $ ( 1,259 )
Other comprehensive income (loss) before reclassifications 222 — 222
Balance at December 31, 2023 $ ( 1,037 ) $ — $ ( 1,037 )
Balance at January 1, 2022 $ ( 754 ) $ 269 $ ( 485 )
Other comprehensive income (loss) before reclassifications ( 505 ) 5,838 5,333
Amounts reclassified to earnings — ( 6,107 ) ( 6,107 )
Balance at December 31, 2022 $ ( 1,259 ) $ — $ ( 1,259 )
15. Stock-Based Compensation
Equity Incentive Plans
As of December 31, 2023, 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, 2021 and 2022 which increased the common stock reserved for issuance under the plan to an aggregate 10,930,277 shares. The Company assumed Progenics equity plans due to the acquisition as discussed in Note 1, “Description of Business”. The Company no longer grants new equity awards under the Progenics equity plans.
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Stock-based compensation expense recognized in the consolidated statements of operations is summarized below:
Year Ended
December 31,
(in thousands) 2023 2022 2021
Cost of goods sold $ 9,126 $ 4,422 $ 2,370
Sales and marketing 9,500 6,185 2,472
General and administrative 24,807 14,876 9,092
Research and development 7,074 3,779 2,000
Total stock-based compensation expense $ 50,507 $ 29,262 $ 15,934
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 2023 is presented below:
Total
Stock
Options Weighted-
Average
Exercise
Price Weighted-
Average
Remaining
Contractual
Term
(Years) Aggregate
Intrinsic
Value
Balance at January 1, 2023 874,749 $ 30.37 5.8 19,058,224
Options granted 332,368 $ 76.41
Options exercised ( 214,619 ) $ 19.02
Options cancelled and forfeited ( 35,326 ) $ 51.30
Outstanding at December 31, 2023 957,172 $ 48.13 6.7 18,283,464
Vested and expected to vest at December 31, 2023 957,172 $ 48.13 6.7 18,283,464
Exercisable at December 31, 2023 466,039 $ 26.99 4.4 16,462,767
The table below summarizes the key weighted-average assumptions used in valuing stock options granted:
Year Ended December 31,
2023 2022 2021
Expected volatility 56.1 % 62.1 % — %
Risk-free interest rate 4.0 % 2.0 % — %
Expected life (in years) 6.0 6.0 —
Expected dividend yield — — —
During the years ended December 31, 2023, 2022 and 2021, 214,619 , 397,822 and 318,662 options were exercised having aggregate intrinsic values of $ 12.9 million, $ 13.1 million and $ 1.6 million, respectively.
As of December 31, 2023, there was $ 13.2 million of unrecognized compensation expense related to outstanding stock options, which is expected to be recognized over a weighted-average period of 2.0 years.
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Restricted Stock
A summary of restricted stock awards and restricted stock units activity for 2023 is presented below:
Shares Weighted-
Average Grant
Date Fair Value Per Share
Nonvested balance at January 1, 2023 1,249,992 $ 34.65
Granted 710,985 $ 74.38
Vested ( 612,912 ) $ 29.78
Forfeited ( 137,806 ) $ 50.36
Nonvested balance at December 31, 2023 1,210,259 $ 58.71
Restricted stock generally vest over 3 years. As of December 31, 2023, there was $ 48.4 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, 2023, 2022 and 2021 was $ 74.38 , $ 51.51 and $ 20.14 per share, respectively. The total fair value of restricted stock vested in fiscal years 2023, 2022 and 2021 was $ 18.3 million, $ 11.9 million and $ 8.8 million, respectively.
Total Stockholder Return Restricted Stock Awards (“TSR Awards”)
During the years ended December 31, 2023, 2022 and 2021, 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,
2023 2022 2021
Expected volatility 52.8 % 56.6 % 54.0 %
Risk-free interest rate 4.6 % 1.7 % 30.0 %
Expected life (in years) 2.8 2.8 2.8
Expected dividend yield — — —
A summary of TSR Award activity for 2023 is presented below:
Shares Weighted-
Average Grant
Date Fair Value Per Share
Nonvested balance at January 1, 2023 658,875 $ 48.58
Granted 365,478 $ 127.75
Vested ( 348,302 ) $ 23.43
Forfeited ( 45,997 ) $ 57.77
Nonvested balance at December 31, 2023 630,054 $ 78.91
As of December 31, 2023, there was $ 26.2 million of unrecognized compensation expense related to outstanding performance 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 TSR Awards granted during the fiscal years ended December 31, 2023, 2022 and 2021 was $ 127.75 , $ 95.31 and $ 31.25 per share, respectively. The total fair value of TSR Awards vested in fiscal years 2023, 2022 and 2021 was $ 8.2 million, $ 8.8 million and $ 2.0 million, respectively.
Common Stock Repurchases
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In December 2022, the Company’s Board of Directors authorized the repurchase of up to $ 150.0 million in aggregate amount of the Company’s common stock under certain circumstances. The Company used approximately $ 75.0 million of the net proceeds from the Notes to repurchase shares of their common stock from purchasers of the Notes in privately negotiated transactions effected with or through one of the initial purchasers or its affiliate. The purchase price per share of the common stock repurchased in such transactions was equal to the closing sale price per share of the Company’s common stock on the date of the offering memorandum used for the Notes, which was $ 56.01 per share. Following this initial repurchase, the Company may from time to time repurchase additional shares of their common stock. In the year ended December 31, 2022, the Company purchased approximately 1.3 million shares of their outstanding common stock for $ 75.0 million as part of the program. The Company did no t purchase any shares of its outstanding common stock in the year ended December 31, 2023.
16. 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.
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 entered into an operating lease agreement in February 2022 to lease office space in Bedford, Massachusetts, under a lease agreement expiring in June 2031, which commenced and was recorded in December 2022 for $ 11.0 million.
On May 4, 2023, the Company entered into a modification to the operating lease for office space in Bedford, Massachusetts, (the “Existing Premises”) that was executed in February 2022. The lease commenced and was recorded in December 2022 for $ 11.0 million and the initial term was set to expire in June 2031. The lease modification includes a lease of additional office and laboratory space at the Bedford location (the “Additional Premises”) for a term of 15 years and 4 months and extends the term of the lease for the Existing Premises to be coterminous with the term of the lease for the Additional Premises. As a result of the extended term for the Existing Premises, the Company recorded an additional right-of-use asset and liability of $ 6.0 million in May 2023. The modification also contains a provision to convert the rent schedule of the Existing Premises from gross to triple net in 2024, which may result in an additional adjustment to the right-of-use asset and liability. In September 2023, the landlord provided notice to the Company that its renovations of the Additional Premises were completed. As a result of the notice, the Company recorded an additional right-of-use asset and liability of $ 23.5 million as of September 1, 2023. To determine the value of the additional right-of-use asset and liability, the Company was required to calculate the discount rate of the lease modification. The discount rate was determined based on the expected lease term and by comparing interest rates in the market for similar borrowings with comparable credit quality of the Company. The lease for the Additional Premises allows for the extension of five years to begin immediately upon the expiration of the original term.
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:
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(in thousands) Classification December 31, 2023 December 31, 2022
Assets
Operating Other long-term assets $ 45,325 $ 19,033
Finance Property, plant and equipment, net 1,438 582
Total leased assets $ 46,763 $ 19,615
Liabilities
Current
Operating Accrued expenses and other liabilities $ 1,904 $ 2,177
Finance Current portion of long-term debt and other borrowings 823 354
Noncurrent
Operating Other long-term liabilities 54,453 25,442
Finance Long-term debt, net and other borrowings 625 231
Total leased liabilities $ 57,805 $ 28,204
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, 2023 Year Ended
December 31, 2022
Operating lease expense $ 4,627 $ 1,797
Finance lease expense
Amortization of ROU assets 795 426
Interest on lease liabilities 81 28
Total lease expense $ 5,503 $ 2,251
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Other information related to leases were as follows:
December 31, 2023 December 31, 2022
Weighted-average remaining lease term (Years):
Operating leases 13.5 7.9
Finance leases 2.3 1.9
Weighted-average discount rate:
Operating leases 7.3 % 4.8 %
Finance leases 6.2 % 4.4 %
(in thousands) Year Ended
December 31, 2023 Year Ended
December 31, 2022
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases $ 3,462 $ 2,440
Operating cash flows from finance leases 81 28
Financing cash flows from finance leases 504 384
ROU assets obtained in exchange for lease obligations:
Operating leases 29,396 11,019
Finance leases 1,437 582
Future minimum lease payments under non-cancellable leases as of December 31, 2023 were as follows:
(in thousands) Operating Leases
Finance Leases
2024 $ 4,624 $ 846
2025 5,413 664
2026 7,090 151
2027 7,312 —
2028 7,453 —
Thereafter 67,642 —
Total future minimum lease payments 99,534 1,661
Less: interest 43,177 213
Total $ 56,357 $ 1,448
17. Other Assets
Other assets are comprised of the following:
December 31,
(in thousands) 2023 2022
Prepaid Expenses $ 16,437 $ 12,887
Other Current Assets 246 205
Total other current assets $ 16,683 $ 13,092
ROU Asset (Note 16) $ 45,325 $ 19,033
Other Long-Term Assets 9,936 15,322
Total other long-term assets $ 55,261 $ 34,355
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18. Net Income (Loss) Per Common Share
A summary of net income (loss) per common share is presented below:
Year Ended
December 31,
(in thousands, except per share amounts) 2023 2022 2021
Net income (loss) $ 326,661 $ 28,067 $ ( 71,279 )
Basic weighted-average common shares outstanding 68,266 68,487 67,486
Effect of dilutive stock options 346 439 —
Effect of dilutive restricted stock 1,428 1,745 —
Effect of convertible debt instrument 199 — —
Diluted weighted-average common shares outstanding 70,239 70,671 67,486
Basic income (loss) per common share $ 4.79 $ 0.41 $ ( 1.06 )
Diluted income (loss) per common share $ 4.65 $ 0.40 $ ( 1.06 )
Antidilutive securities excluded from diluted net income (loss) per common share 421 358 2,893
Impact of the Convertible Notes
The Company considered whether the notes are participating securities through the two-class method. The Company determined that if a cash dividend is paid that is greater than the then stock price, the holder of Notes will receive cash on an if-converted basis. While this feature is considered to be a participating right; basic earnings per share is only impacted if the Company’s earning exceeds the current share price, regardless of whether such dividend is declared. During the year ended December 31, 2023, no such dividend was declared. In addition, the Company is required to settle the principal amount of the Notes in cash upon conversion, and therefore, the Company uses the if-converted method for calculating any potential dilutive effect of the conversion option on diluted net income per share, if applicable, unless the application of the two-class method is dilutive. The conversion option will have a dilutive impact on net income per share of Common Stock when the average price per share of the Company’s Common Stock for a given period exceeds the conversion price of the Notes of $ 79.81 per share.
19. 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, 2023, future payments required under purchase commitments are as follows:
(in thousands) Amount
2024 2,716
2025 2,716
2026 2,716
2027 2,716
2028 and thereafter —
Total $ 10,864
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, 2023, no future fixed payments are required under license agreements. The Company may be required to pay additional amounts up to approximately $ 264.4 million in contingent payments under the Company’s license agreements. These
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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.
As of December 31, 2023, the Company did not have any material ongoing litigation to which the Company was a party. On January 26, 2024, the Company was sued in the United States District Court for the District of Delaware by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA, each a Novartis entity, for patent infringement in response to the filing of our ANDA and Paragraph IV certification, consistent with the process established by the Hatch-Waxman Act. Because the outcome of litigation is uncertain, the Company cannot predict how or when this matter will ultimately be resolved.
20. 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 $ 4.1 million, $ 3.1 million and $ 2.6 million for the years ended December 31, 2023, 2022 and 2021, respectively.
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21. Acquisition of Assets
On February 6, 2023, the Company acquired Cerveau. Cerveau holds the rights under a license agreement to develop and commercialize MK-6240, an investigational second-generation F 18-labeled positron emission tomography (“PET”) imaging agent that targets Tau tangles in Alzheimer’s disease. The Company determined that upon review of the Cerveau acquisition, the transaction did not meet the definition of a business combination and is therefore treated as an asset acquisition.
In February 2023, the Company made an upfront payment of approximately $ 35.3 million to the stockholders of Cerveau (the “Selling Stockholders”) and paid the Selling Stockholders an additional $ 10.0 million in May 2023 upon the successful completion of a technology transfer. The Company could pay up to an additional $ 51.0 million in milestone payments upon achievement of specified U.S. regulatory milestones related to MK-6240. The Selling Stockholders are also eligible to receive up to $ 1.2 billion in sales milestone payments upon the achievement of specified annual commercial sales thresholds of MK-6240 in the event the Company pursues commercialization, as well as up to $ 13.5 million in research revenue milestones upon achievement of specified annual research revenue thresholds. Additionally, the Company will pay to the Selling Stockholders up to double-digit royalty payments for research revenue and commercial sales. Research revenue is derived from existing partnerships with pharmaceutical companies that use MK-6240 in clinical trials and includes milestone and dose-related payments. The purchase agreement pursuant to which the Company purchased Cerveau specifies, among other things, that certain members of the Selling Stockholders will also provide transition and clinical development services for a prescribed time following the closing of the transaction.
In December 2022, the Company made upfront payments of $ 260.0 million to POINT as a part of an asset acquisition with the potential for additional milestone payments of approximately $ 1.8 billion between the two licensed assets based on U.S. Food and Drug Administration (“FDA”) approval and net sales and commercial milestones.
Under the terms of the PNT2002 License Agreement, Lantheus Two paid POINT an upfront cash payment of $ 250.0 million, and could pay up to an additional $ 281.0 million in milestone payments upon the achievement of specified U.S. and ex-U.S. regulatory milestones related to PNT2002. POINT is also eligible to receive up to $ 1.3 billion in sales milestone payments upon the achievement of specified annual sales thresholds of PNT2002.
Under the terms of the PNT2003 License Agreement, Lantheus Three paid POINT an upfront cash payment of $ 10.0 million, and could pay up to an additional $ 34.5 million in milestone payments upon the achievement of specified U.S. and ex-U.S. regulatory milestones related to PNT2003. POINT is also eligible to receive up to $ 275.0 million in sales milestone payments upon the achievement of specified annual sales thresholds of PNT2003.
Additionally, the Company will pay POINT royalties on net sales, beyond certain financial thresholds and subject to conditions, of 20 % for PNT2002 and 15 % for PNT2003. Costs of IPR&D projects acquired as part of an asset acquisition that have no alternative future use are expensed when incurred, and therefore, a charge of $ 260.0 million was recognized in research and development expenses during the year ended December 31, 2022.
22. Segment Information
The Company operates as one business segment. The results of this operating segment are regularly reviewed by the Company’s chief operating decision maker, the 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 Event
On January 9, 2024, the Company entered into multiple strategic agreements with Perspective Therapeutics, Inc. (“Perspective”), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. Under the agreements:
• The Company obtained an option to exclusively license Perspective’s Pb212-VMT-⍺-NET, a clinical stage alpha therapy in development for the treatment of neuroendocrine tumors, and an option to co-develop certain early stage therapeutic candidates targeting prostate cancer using Perspective’s innovative platform technology, for an aggregate upfront payment of $ 28 million in cash;
• Lantheus agreed to purchase up to 19.9 % of Perspective’s outstanding shares of common stock for up to approximately $ 33 million, subject to completion of a qualified third party financing transaction and certain other closing conditions; and
• Perspective agreed to acquire the assets and associated lease of Lantheus’ radiopharmaceutical manufacturing facility in Somerset, New Jersey for an undisclosed price, subject to customary closing conditions including regulatory approval.
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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Not applicable.