Item 1. Financial Statements
Item 1. Financial Statements
Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except par value)
September 30,
2024 December 31,
2023
Assets
Current assets
Cash and cash equivalents $ 866,386 $ 713,656
Accounts receivable, net 329,336 284,292
Inventory 70,835 64,029
Other current assets 21,998 16,683
Assets held for sale 7,159 7,159
Total current assets 1,295,714 1,085,819
Investment in equity securities 158,791 —
Property, plant and equipment, net 169,512 146,697
Intangibles, net 173,606 151,985
Goodwill 61,189 61,189
Deferred tax assets, net 144,641 150,198
Other long-term assets 46,177 55,261
Total assets $ 2,049,630 $ 1,651,149
Liabilities and stockholders’ equity
Current liabilities
Current portion of long-term debt and other borrowings $ 564,713 $ 823
Accounts payable 44,914 41,189
Accrued expenses and other liabilities 174,452 145,338
Total current liabilities 784,079 187,350
Asset retirement obligations 23,237 22,916
Long-term debt, net and other borrowings 613 561,670
Other long-term liabilities 61,993 63,321
Total liabilities 869,922 835,257
Commitments and contingencies (See Note 18)
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; 70,854 and 69,863 shares issued as of September 30, 2024 and December 31, 2023, respectively)
709 699
Additional paid-in capital 797,430 757,727
Treasury Stock at cost - 1,339 shares as of September 30, 2024 and December 31, 2023
( 75,000 ) ( 75,000 )
Retained earnings 457,735 133,503
Accumulated other comprehensive loss ( 1,166 ) ( 1,037 )
Total stockholders’ equity 1,179,708 815,892
Total liabilities and stockholders’ equity $ 2,049,630 $ 1,651,149
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Lantheus Holdings, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
Three Months Ended
September 30, Nine Months Ended
September 30,
2024 2023 2024 2023
Revenues $ 378,734 $ 319,946 $ 1,142,800 $ 942,430
Cost of goods sold 136,608 119,995 403,054 462,756
Gross profit 242,126 199,951 739,746 479,674
Operating expenses
Sales and marketing 43,719 37,399 134,300 106,472
General and administrative 40,516 35,741 135,820 85,163
Research and development 24,148 14,450 132,773 60,883
Total operating expenses 108,383 87,590 402,893 252,518
Gain on sale of assets — — 6,254 —
Operating income 133,743 112,361 343,107 227,156
Interest expense 4,903 5,054 14,624 14,978
Investment in equity securities - unrealized gain ( 37,325 ) — ( 75,492 ) —
Other income ( 9,953 ) ( 52,649 ) ( 27,785 ) ( 60,362 )
Income before income taxes 176,118 159,956 431,760 272,540
Income tax expense 45,025 27,999 107,528 49,259
Net income $ 131,093 $ 131,957 $ 324,232 $ 223,281
Net income per common share:
Basic $ 1.89 $ 1.93 $ 4.69 $ 3.27
Diluted $ 1.79 $ 1.88 $ 4.55 $ 3.18
Weighted-average common shares outstanding:
Basic 69,464 68,436 69,193 68,188
Diluted 73,065 70,046 71,331 70,268
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Lantheus Holdings, Inc.
Condensed Consolidated Statements of Comprehensive Income
(Unaudited)
(in thousands)
Three Months Ended
September 30, Nine Months Ended
September 30,
2024 2023 2024 2023
Net income $ 131,093 $ 131,957 $ 324,232 $ 223,281
Other comprehensive income (loss):
Foreign currency translation 44 ( 83 ) ( 129 ) 224
Comprehensive income $ 131,137 $ 131,874 $ 324,103 $ 223,505
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Lantheus Holdings, Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
(Unaudited)
(in thousands)
Nine Months Ended September 30, 2024
Common Stock Treasury Stock Additional
Paid-In
Capital Retained earnings Accumulated
Other
Comprehensive
(Loss) Income Total
Stockholders’
Equity
Shares Amount Shares Amount
Balance, January 1, 2024
69,863 $ 699 1,339 $ ( 75,000 ) $ 757,727 $ 133,503 $ ( 1,037 ) $ 815,892
Net income — — — — — 131,066 — 131,066
Other comprehensive loss — — — — — — ( 141 ) ( 141 )
Stock option exercises and employee stock plan purchases 86 1 — — 2,756 — — 2,757
Vesting of restricted stock awards and units 988 9 — — ( 9 ) — — —
Shares withheld to cover taxes ( 302 ) ( 3 ) — — ( 19,415 ) — — ( 19,418 )
Stock-based compensation — — — — 15,384 — — 15,384
Balance, March 31, 2024
70,635 $ 706 1,339 $ ( 75,000 ) $ 756,443 $ 264,569 $ ( 1,178 ) $ 945,540
Net income — — — — — 62,073 — 62,073
Other comprehensive loss — — — — — — ( 32 ) ( 32 )
Stock option exercises and employee stock plan purchases 68 1 — — 1,548 — — 1,549
Vesting of restricted stock awards and units 58 1 — — ( 1 ) — — —
Shares withheld to cover taxes ( 11 ) — — — ( 924 ) — — ( 924 )
Stock-based compensation — — — — 18,479 — — 18,479
Balance, June 30, 2024
70,750 $ 708 1,339 ( 75,000 ) $ 775,545 $ 326,642 $ ( 1,210 ) $ 1,026,685
Net income — — — — — — 131,093 — 131,093
Other comprehensive income — — — — — — 44 44
Stock option exercises and employee stock plan purchases 76 1 — — 2,831 — — 2,832
Vesting of restricted stock awards and units 40 — — — — — — —
Shares withheld to cover taxes ( 12 ) — — — ( 1,312 ) — — ( 1,312 )
Stock-based compensation — — — — 20,366 — — 20,366
Balance, September 30, 2024
70,854 $ 709 1,339 $ ( 75,000 ) $ 797,430 $ 457,735 $ ( 1,166 ) $ 1,179,708
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Nine Months Ended September 30, 2023
Common Stock Treasury Stock Additional
Paid-In
Capital Accumulated
Deficit Accumulated
Other
Comprehensive
(Loss) Income Total
Stockholders’
Equity
Shares Amount Shares Amount
Balance, January 1, 2023
68,851 $ 689 1,339 $ ( 75,000 ) $ 715,875 $ ( 193,158 ) $ ( 1,259 ) $ 447,147
Net loss — — — — — ( 2,807 ) — ( 2,807 )
Other comprehensive loss — — — — — — ( 119 ) ( 119 )
Stock option exercises and employee stock plan purchases 120 1 — — 2,781 — — 2,782
Vesting of restricted stock awards and units 813 8 — — ( 8 ) — — —
Shares withheld to cover taxes ( 154 ) ( 2 ) — — ( 11,152 ) — — ( 11,154 )
Stock-based compensation — — — — 9,667 — — 9,667
Balance, March 31, 2023
69,630 $ 696 1,339 $ ( 75,000 ) $ 717,163 $ ( 195,965 ) $ ( 1,378 ) $ 445,516
Net income — — — — — 94,131 — 94,131
Other comprehensive income — — — — — — 426 426
Stock option exercises and employee stock plan purchases 73 1 — — 1,346 — — 1,347
Vesting of restricted stock awards and units 68 1 — — ( 1 ) — — —
Shares withheld to cover taxes ( 16 ) — — — ( 1,467 ) — — ( 1,467 )
Stock-based compensation — — — — 12,692 — — 12,692
Balance, June 30, 2023
69,755 $ 698 1,339 $ ( 75,000 ) $ 729,733 $ ( 101,834 ) $ ( 952 ) $ 552,645
Net income — — — — — 131,957 — 131,957
Other comprehensive loss — — — — — — ( 83 ) ( 83 )
Stock option exercises and employee stock plan purchases 25 — — — 1,265 — — 1,265
Vesting of restricted stock awards and units 39 — — — ( 1 ) — — ( 1 )
Shares withheld to cover taxes ( 11 ) — — — ( 1,000 ) — — ( 1,000 )
Stock-based compensation — — — — 13,976 — — 13,976
Balance, September 30, 2023
69,808 $ 698 1,339 $ ( 75,000 ) $ 743,973 $ 30,123 $ ( 1,035 ) $ 698,759
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Lantheus Holdings, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
Nine Months Ended
September 30,
2024 2023
Cash flows from operating activities:
Net income $ 324,232 $ 223,281
Adjustments to reconcile net income to net cash flows from operating activities:
Depreciation, amortization and accretion 47,339 45,028
Impairment of long-lived assets — 138,050
Amortization of debt related costs 3,217 3,227
Changes in fair value of contingent assets and liabilities ( 1,405 ) ( 9,475 )
Inventory adjustments 738 5,251
Stock-based compensation 54,229 36,335
Gain on disposal of assets ( 6,254 ) —
Gain on sale of RELISTOR licensed intangible asset associated with net sales royalties — ( 51,789 )
Unrealized gain on investment in equity securities ( 75,492 ) —
Charges incurred in connection with acquired IPR&D 66,000 —
Deferred taxes ( 4,402 ) ( 57,649 )
Long-term indemnification receivable — 3,929
Long-term income tax payable and other long-term liabilities 2,619 ( 2,744 )
Other 7,172 3,118
Changes in assets and liabilities which provided (used) cash:
Accounts receivable ( 44,887 ) ( 43,044 )
Inventory ( 7,101 ) ( 25,995 )
Other current assets 1,335 2,496
Accounts payable 1,151 12,150
Accrued expenses and other liabilities 18,529 ( 89,196 )
Net cash provided by operating activities 387,020 192,973
Cash flows from investing activities:
Capital expenditures ( 35,256 ) ( 34,486 )
Acquisition of assets, net ( 80,911 ) ( 45,345 )
Proceeds from sale of assets 8,000 97,839
Purchases of investment in equity securities ( 83,246 ) —
Acquisition of exclusive license option ( 28,000 ) —
Net cash (used in) provided by investing activities ( 219,413 ) 18,008
Cash flows from financing activities:
Payments on long-term debt and other borrowings ( 376 ) ( 685 )
Contingent value rights settlement — ( 3,700 )
Proceeds from stock option exercises 3,772 3,462
Proceeds from issuance of common stock 3,450 1,933
Payments for minimum statutory tax withholding related to net share settlement of equity awards ( 21,723 ) ( 13,621 )
Net cash used in financing activities ( 14,877 ) ( 12,612 )
Effect of foreign exchange rates on cash, cash equivalents and restricted cash 34 139
Net increase in cash, cash equivalents and restricted cash 152,764 198,508
Cash, cash equivalents and restricted cash, beginning of period 715,285 417,241
Cash, cash equivalents and restricted cash, end of period $ 868,049 $ 615,749
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Lantheus Holdings, Inc.
Condensed Consolidated Statements of Cash Flows (Continued)
(Unaudited)
(in thousands)
Nine Months Ended
September 30,
2024 2023
Reconciliation to amounts within the condensed consolidated balance sheets
Cash and cash equivalents $ 866,386 $ 614,131
Restricted cash included in other long-term assets 1,663 1,618
Cash, cash equivalents and restricted cash at end of period $ 868,049 $ 615,749
Nine Months Ended
September 30,
2024 2023
Schedule of non-cash investing and financing activities
Additions of property, plant and equipment included in liabilities $ 8,502 $ 8,573
Lease liability settled through transfer of lease $ 762 $ —
Right-of-use asset obtained in exchange for operating lease liabilities $ 63 $ 29,625
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Lantheus Holdings, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note Regarding Company References and Trademarks
Unless the context otherwise requires, references to the “Company” and “Lantheus” refer to Lantheus Holdings, Inc. and its direct and indirect wholly-owned subsidiaries; references to “Lantheus Holdings” refer to Lantheus Holdings, Inc. and not to any of its subsidiaries; references to “LMI” refer to Lantheus Medical Imaging, Inc., the direct subsidiary of Lantheus Holdings; references to “Lantheus Alpha” and “Meilleur” refer to Lantheus Alpha Therapy, LLC and Meilleur Technologies, Inc., respectively, each a direct subsidiary of Lantheus Holdings; references to “Cerveau,” “Lantheus Real Estate,” “Lantheus Two,” “Lantheus Three” and “Progenics” refer to Cerveau Technologies, Inc.; Lantheus MI Real Estate, LLC; Lantheus Two, LLC; Lantheus Three, LLC; and Progenics Pharmaceuticals, Inc., respectively, each a wholly-owned subsidiary of LMI, and references to “EXINI” refer to EXINI Diagnostics AB, a wholly-owned subsidiary of Progenics. Solely for convenience, the Company refers to trademarks, service marks and trade names without the TM, SM and ® symbols. Those references are not intended to indicate, in any way, that the Company will not assert, to the fullest extent permitted under applicable law, its rights to its trademarks, service marks and trade names.
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include the accounts of Lantheus and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) for interim financial information and with the instructions for Quarterly Reports on Form 10-Q and Article 10 of Regulation S-X. Accordingly, these condensed consolidated financial statements do not include all of the information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal and recurring adjustments) considered necessary for a fair statement have been included. The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for any future period.
The condensed consolidated balance sheet at December 31, 2023 has been derived from the audited consolidated financial statements at that date but does not include all the information and notes required by U.S. GAAP for complete financial statements. These condensed consolidated financial statements and accompanying notes should be read in conjunction with the consolidated financial statements and notes thereto included in Item 8 of the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities Exchange Commission (“SEC”) on February 22, 2024.
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 Lantheus Holdings, Plato Merger Sub, Inc., a wholly-owned subsidiary of Lantheus Holdings (“Merger Sub”), and Progenics, Lantheus Holdings completed the acquisition of Progenics by means of a merger of Merger Sub with and into Progenics, with Progenics becoming an indirect subsidiary of Lantheus Holdings following the completion of such merger (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
Investments
Equity investments with readily determinable fair values for which the Company does not have significant influence over the investee are measured at fair value on a recurring basis. Equity investments without readily determinable fair values for which the Company does not have significant influence over the investee are measured at cost with adjustments for observable changes in price or impairments (referred to as the measurement alternative). For equity investments for which the Company does not have significant influence over the investee, changes in the value of unsold equity investments are recorded in investment in equity securities – unrealized gain. Equity investments for which the Company has significant influence over the investee are measured using the equity method unless the Company elects to apply the fair value option to account for the investment.
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Recent Accounting Pronouncements
The Company has considered all new accounting standards issued by the Financial Accounting Standards Board (“FASB”). The Company has not yet adopted the following standards:
In December 2023, the FASB issued Accounting Standards Update (“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.
3. Revenue from Contracts with Customers
The following table summarizes revenue by source as follows:
Three Months Ended
September 30, Nine Months Ended
September 30,
Major Products/Service Lines (in thousands) 2024 2023 2024 2023
Product revenue, net (1)
$ 374,601 $ 319,508 $ 1,136,670 $ 925,848
License and royalty revenues 4,133 438 6,130 16,582
Total revenues $ 378,734 $ 319,946 $ 1,142,800 $ 942,430
________________________________
(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 its principal products.
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 the first quarter of 2024, the Company discontinued the production of AZEDRA. Precision Diagnostics includes DEFINITY, TechneLite and other diagnostic imaging products. Strategic Partnerships and Other Revenue primarily includes out-licensing arrangements and partnerships for the Company’s biomarker solutions, digital solutions, and radiotherapeutic platforms, inclusive of two investigational stage diagnostic agents, MK-6240 and NAV-4694. On August 2, 2023, the Company sold its rights to the RELISTOR net sales royalty asset (the “RELISTOR royalty asset”) under its license agreement with Bausch Health Companies, Inc. (“Bausch”); the Company retained the rights to future sales-based milestone payments.
Revenue by product category on a net basis is as follows:
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Three Months Ended
September 30, Nine Months Ended
September 30,
(in thousands) 2024 2023 2024 2023
PYLARIFY $ 259,756 $ 215,428 $ 791,881 $ 621,419
Other radiopharmaceutical oncology — 848 384 2,383
Total radiopharmaceutical oncology 259,756 216,276 792,265 623,802
DEFINITY 76,965 67,336 231,629 206,688
TechneLite 20,480 23,272 70,380 65,853
Other precision diagnostics 6,282 5,740 18,039 17,002
Total precision diagnostics 103,727 96,348 320,048 289,543
Strategic partnerships and other revenue 15,251 7,322 30,487 29,085
Total revenues $ 378,734 $ 319,946 $ 1,142,800 $ 942,430
The Company is required to allocate a portion of its revenue received from commercial contracts to future reporting periods to the extent the Company had performance obligations that extended beyond one year. However, 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.
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.
Financial assets and liabilities measured at fair value on a recurring basis consist of money market funds, contingent consideration liabilities, and equity investments. The Company invests excess cash from its operating cash accounts in overnight investments and reflects these amounts in cash and cash equivalents in the condensed consolidated balance sheets at fair value using quoted prices in active markets for identical assets. Investment in equity securities resulting from the Perspective Therapeutics, Inc. (“Perspective”) strategic agreements were recorded at fair value by the Company and are adjusted for price changes observable in the market each quarter. The Company recorded the contingent consideration liabilities resulting from the Progenics Acquisition at fair value based on inputs that are not observable in the market.
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The tables below present information about the Company’s assets and liabilities measured at fair value on a recurring basis:
September 30, 2024
(in thousands) Total Fair
Value Level 1 Level 2 Level 3
Assets:
Money market funds $ 669,158 $ 669,158 $ — $ —
Investment securities 158,791 158,791 — —
Total assets $ 827,949 $ 827,949 $ — $ —
Liabilities:
Contingent consideration liabilities $ 1,294 $ — $ — $ 1,294
Total liabilities $ 1,294 $ — $ — $ 1,294
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
During the three and nine months ended September 30, 2024, there were no transfers into or out of Level 3.
Perspective Therapeutics Inc. Equity Securities
At September 30, 2024, the Company held 11,677,339 shares of Perspective common stock (“Perspective Shares”). The Company accounts for its investment in Perspective Shares as an equity investment with a readily determinable fair value, as the securities are publicly traded on the New York Stock Exchange (“NYSE”). The fair value of the equity securities is based on its closing price on the NYSE at the end of the fiscal period and is classified within Level 1 of the fair value hierarchy because the equity securities are valued using quoted market prices. The fair value of the Perspective Shares as of September 30, 2024 was approximately $ 155.9 million based on a closing market price of $ 13.35 per share on September 30, 2024, resulting in an unrealized gain of $ 39.5 million and $ 77.6 million for the three and nine months ended September 30, 2024, respectively. See Note 19, "Acquisition of Assets" for further discussion of the Perspective transaction.
Radiopharm Theranostics Limited Equity Securities
At September 30, 2024, the Company held 149,625,180 shares of Radiopharm Theranostics Limited (“Radiopharm”) common stock (“Radiopharm Shares”). The Company accounts for its investment in Radiopharm Shares as an equity investment with a readily determinable fair value, as the securities are publicly traded on the Australian Stock Exchange (“ASX”). The fair value of the equity securities is based on the closing price on the ASX at the end of the fiscal period and is classified within Level 1 of the fair value hierarchy because the equity securities are valued using quoted market prices. The fair value of the Radiopharm Shares as of September 30, 2024 was approximately $ 2.9 million based on the converted closing market price of approximately $ 0.02 per share on September 30, 2024, resulting in an unrealized loss on equity securities of $ 2.1 million for the three and nine months ended September 30, 2024. See Note 19, "Acquisition of Assets" for further discussion of the Radiopharm transaction.
Contingent Consideration
The Company assumed contingent consideration liabilities related to a previous acquisition completed by Progenics in 2013 (“2013 Acquisition”). These contingent consideration liabilities include potential payments of up to $ 70.0 million if the Company attains certain net sales targets primarily for AZEDRA and 1095 (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 for a commercialization milestone related to a prostate cancer product candidate the Company refers to as “1404” that was out-licensed to ROTOP Pharmaka GmbH. 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
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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 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 condensed 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 at September 30, 2024.
Fair Value at Assumptions
(in thousands) September 30, 2024 December 31,
2023 Valuation Technique Unobservable Input September 30, 2024 December 31,
2023
Contingent consideration liability:
1095 commercialization milestone 1,800 1,800 Probability adjusted discounted cash flow model
Period of expected milestone achievement 2026 2026
Probability of success 40 % 40 %
Discount rate 3.5 % 4.1 %
Net sales targets - AZEDRA and 1095 1,000 900 Monte Carlo simulation
Probability of success and sales targets 0 % - 40 %
0 % - 40 %
Discount rate 15 %
15 %
Reduction due to partial settlement of 2013 Milestone Rights ( 1,506 ) —
Total $ 1,294 $ 2,700
For those financial instruments with significant Level 3 inputs, the following table summarizes the activities for the periods indicated:
Financial Liabilities
(in thousands) Nine Months Ended
September 30,
2024 2023
Fair value, beginning of period $ 2,700 $ 111,600
Changes in fair value included in net income 100 ( 9,475 )
Gain on partial buyout of 2013 Milestone Rights ( 1,505 ) —
Cash payments ( 1 ) ( 99,625 )
Fair value, end of period $ 1,294 $ 2,500
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The change in fair value of the contingent financial liabilities resulted in an increase of general and administrative expense of $ 0.1 million for the nine months ended September 30, 2024 and was primarily due to the passage of time. In August 2024, the Company entered into a bill of sale with the holder of a significant portion of the contingent milestone rights related to the 2013 Acquisition (the “2013 Milestone Rights”) to transfer their portion of the 2013 Milestone Rights back to the Company for $ 1,000 . This buyout resulted in a $ 1.5 million decrease in general and administrative expense during the three months ended September 30, 2024 due to the reduction in outstanding 2013 Milestone Rights.
As of September 30, 2024, the carrying value of the Company’s convertible debt was $ 575.0 million and the fair value of the Company’s convertible debt was estimated to be approximately $ 892.4 million based on quoted market prices of the instrument and was classified as a Level 1 measurement within the fair value hierarchy.
5. Income Taxes
The Company calculates income taxes at the end of each reporting period based on the estimated effective tax rate for the full year, adjusted for any discrete events which are recorded in the period they occur. Cumulative adjustments to the tax provision are recorded in the reporting period in which a change in the estimated annual effective tax rate is determined. The Company’s income tax expense and effective tax rate are presented below:
Three Months Ended
September 30, Nine Months Ended
September 30,
(in thousands) 2024 2023 2024 2023
Income tax expense $ 45,025 $ 27,999 $ 107,528 $ 49,259
Effective tax rate 25.6 % 17.5 % 24.9 % 18.1 %
The increase in the effective income tax rate for the three and nine months ended September 30, 2024 is primarily due to a benefit recorded in the third quarter of 2023 related to the sale of the Company’s RELISTOR royalty asset, which resulted in additional net operating losses becoming available for utilization under Internal Revenue Code Section 382. There was no such comparable amount recorded in 2024.
6. Inventory
Inventory consisted of the following:
(in thousands) September 30,
2024 December 31,
2023
Raw materials $ 28,729 $ 31,259
Work in process 21,178 13,807
Finished goods 20,928 18,963
Total inventory $ 70,835 $ 64,029
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 September 30, 2024. The majority of inventory on hand relates to in-house manufacturing of DEFINITY at the Company’s North Billerica campus. With respect to the Company’s products that are radiopharmaceuticals, due to the limited shelf life of such products, they are generally not held as finished goods.
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7. Property, Plant and Equipment, Net
Property, plant and equipment, net, consisted of the following:
(in thousands) September 30,
2024 December 31,
2023
Land $ 9,480 $ 9,480
Buildings 81,940 73,441
Machinery, equipment and fixtures 105,900 102,576
Computer software 54,182 27,259
Construction in progress 35,177 40,964
286,679 253,720
Less: accumulated depreciation and amortization ( 117,167 ) ( 107,023 )
Total property, plant and equipment, net $ 169,512 $ 146,697
Depreciation and amortization expense related to property, plant and equipment, net, was $ 5.1 million and $ 2.9 million for the three months ended September 30, 2024 and 2023, respectively, and $ 15.1 million and $ 9.6 million for the nine months ended September 30, 2024 and 2023, respectively.
During the nine months ended September 30, 2023, as a result of a decline in expected future cash flows related to the AZEDRA marketed intangible asset, 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 nine months ended September 30, 2023 in cost of goods sold in the condensed consolidated statements of operations.
On January 8, 2024, the Company entered into an agreement with Perspective to transfer the sublease for the property at 110 Clyde Rd, Somerset, New Jersey (the “Somerset Facility”) and sell the associated assets at the Somerset Facility for $ 8.0 million. The transfer of the sublease and completion of the asset sale occurred on March 1, 2024. The sale of assets resulted in a derecognition to the right-of-use asset of $ 0.4 million, the lease liability of $ 0.4 million and remaining property, plant and equipment of $ 0.8 million. The Company also incurred commission expense of $ 1.0 million related to the transaction. The Company recorded a gain of $ 6.3 million for the nine months ended September 30, 2024 within operating income.
See Note 19, "Acquisition of Assets" for further discussion of the Perspective transaction.
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 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, 2024. The purchase price for the campus sale is $ 10.0 million in cash. The transaction is expected to close in 2024.
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8. Accrued Expenses, Other Liabilities and Other Long-Term Liabilities
Accrued expenses, other liabilities and other long-term liabilities are comprised of the following:
(in thousands) September 30,
2024 December 31,
2023
Compensation and benefits $ 35,740 $ 36,331
Freight, distribution and operations 83,735 67,529
Accrued rebates, discounts and chargebacks 21,924 16,070
Accrued professional fees 11,177 10,244
Accrued research and development expenses 7,048 3,258
Other 14,828 11,906
Total accrued expenses and other liabilities $ 174,452 $ 145,338
Operating lease liabilities (Note 15)
$ 53,915 $ 54,453
Long-term contingent liabilities (Note 4)
1,294 2,700
Other long-term liabilities 6,784 6,168
Total other long-term liabilities $ 61,993 $ 63,321
9. Asset Retirement Obligations
The Company considers its legal obligation to remediate its facilities upon a potential decommissioning of its radioactive-related operations as an asset retirement obligation. The Company has a production facility that manufactures and processes radioactive materials at its North Billerica, Massachusetts site. As of September 30, 2024, the asset retirement liability is measured at the present value of the asset retirement liability expected to be incurred and is approximately $ 25.1 million.
The following table provides a summary of the changes in the Company’s carrying value of asset retirement obligations:
(in thousands) Amount
Balance at January 1, 2024
$ 22,916
Accretion expense 321
Balance at September 30, 2024
$ 23,237
The Company is required to provide the Massachusetts Department of Public Health financial assurance demonstrating the Company’s ability to fund any decommissioning of its North Billerica, Massachusetts production facility in the event of any closure. The Company has provided this financial assurance in the form of a $ 30.3 million surety bond.
10. Intangibles, Net
Intangibles, net, consisted of the following:
September 30, 2024
(in thousands) Useful Lives
(in years) Amortization Method Cost Accumulated Amortization Net
Trademarks 15 - 25
Straight-Line $ 13,540 $ ( 12,326 ) $ 1,214
Customer relationships 15 - 25
Accelerated 157,950 ( 132,025 ) 25,925
Currently marketed products 9 - 15
Straight-Line 132,800 ( 49,344 ) 83,456
Licenses 11 - 16
Straight-Line 22,233 ( 11,895 ) 10,338
Developed technology 7 - 9
Straight-Line 55,982 ( 3,309 ) 52,673
Total $ 382,505 $ ( 208,899 ) $ 173,606
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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 products 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
The Company recorded amortization expense for its intangible assets of $ 11.9 million and $ 11.7 million for the three months ended September 30, 2024 and 2023, respectively and $ 32.0 million and $ 35.1 million for the nine months ended September 30, 2024 and 2023, respectively.
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. 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 quarter ended March 31, 2023.
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.
On August 15, 2023, the Company announced that it would discontinue the production and promotion of AZEDRA and would be winding down its Somerset Facility. The Company continued manufacturing AZEDRA until the first quarter of 2024 to provide doses of AZEDRA to then-current patients so they could complete their treatment regimen. No AZEDRA was manufactured after March 1, 2024, when the Company transferred the tangible assets and associated lease of its Somerset Facility to Perspective. 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 (the “Cerveau Stockholders”) to purchase all of the outstanding capital stock of Cerveau (which holds the rights under a license agreement to develop and commercialize MK-6240) for approximately $ 35.3 million. In May 2023, upon successful completion of a technology transfer, the Company paid $ 10.0 million to the Cerveau Stockholders. This additional contingent payment was capitalized as part of the asset cost and increased the total value of the Company’s customer relationship intangible assets. See Note 19, "Acquisition of Assets" for further discussion of the Cerveau acquisition.
In June 2024, the Company entered into an agreement with the stockholders of Meilleur (“Meilleur Stockholders”) to purchase all of the outstanding capital stock of Meilleur (which holds the rights under a license agreement to develop and commercialize NAV-4694) for approximately $ 32.9 million. The Company recorded a developed technology intangible asset of $ 40.3 million as a result of the purchase price and the specific assets and liabilities of Meilleur that were acquired as part of the asset acquisition based on their value at the agreed upon closing date. In August 2024, upon successful completion of a technology transfer, the Company paid $ 10.0 million to the Meilleur Stockholders. This additional contingent payment was capitalized as part of the asset cost and
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increased the total value of the Company’s developed technology intangible assets. See Note 19, "Acquisition of Assets" for further discussion of the Meilleur acquisition.
The below table summarizes the estimated aggregate amortization expense expected to be recognized on the above intangible assets:
(in thousands) Amount
Remainder of 2024 $ 11,843
2025 32,064
2026 32,861
2027 27,335
2028 23,850
2029 and thereafter
45,653
Total $ 173,606
11. Long-Term Debt, Net, and Other Borrowings
The carrying value of the Company’s long-term debt, net and other borrowings is as follows:
(in thousands) September 30, 2024 December 31, 2023
Principal amount 2.625 % Convertible Senior Notes due 2027
$ 575,000 $ 575,000
Unamortized debt issuance costs ( 11,283 ) ( 13,955 )
Finance lease liabilities 1,609 1,448
Total 565,326 562,493
Less: current portion of long-term debt and other borrowings (1)
( 564,713 ) ( 823 )
Total long-term debt, net and other borrowings $ 613 $ 561,670
(1) During the three months ended September 30, 2024, as discussed below, criteria were met for conversion of the 2.625 % Convertible Senior Notes due 2027 (the “Notes”) at the option of the holders of the Notes. As a result, under ASC 470, “Debt”, the Company is required to classify the carrying value as current on the Company’s condensed consolidated balance sheet at September 30, 2024. The maturity date of the Notes remains December 15, 2027.
2022 Revolving Facility
In December 2022, the Company entered into a $ 350.0 million five-year revolving credit facility (the “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 Revolving Loans, Letters of Credit, and the Swingline 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. Interest associated with the unused commitment is recorded to accrued expenses and other liabilities on the condensed consolidated balance sheet and paid out on a quarterly basis.
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 September 30, 2024, 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 earnings before interest, taxes, depreciation and amortization for the four consecutive fiscal
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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 Revolving 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 must be at least 3.00 to 1.00. The maximum total net leverage ratio permitted by the financial covenant is 3.50 to 1.00.
The 2022 Revolving 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 Revolving Facility immediately due and payable and all commitments immediately terminated.
The 2022 Revolving Facility is guaranteed by Lantheus Holdings, and certain subsidiaries of LMI, including Progenics and Lantheus Real Estate, and obligations under the 2022 Revolving Facility are generally secured by first priority liens over substantially all of the assets of each of LMI, Lantheus Holdings, and certain subsidiaries of LMI, including Progenics and Lantheus Real Estate (subject to customary exclusions set forth in the transaction documents) owned as of December 2, 2022 or thereafter acquired.
2.625 % Convertible Senior Notes due 2027
On December 8, 2022, the Company issued $ 575.0 million in aggregate principal amount of 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 conversion rate per $1,000 in principal amount of the 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.
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• 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 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 Company affiliates or holders that were Company affiliates at any time during the three months immediately preceding as of the 385th day after the last date of original issuance of the Notes, 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.
Holders of the Notes may require the Company to repurchase their Notes upon the occurrence of a fundamental change prior to the maturity at a repurchase price equal to 100 % of the principal amount thereof, plus accrued and unpaid interest to, but excluding, the date of repurchase. In connection with certain triggering events, the Company will, under certain circumstances, increase the conversion rate for holders of the Notes who elect to convert their Notes in connection with such corporate events.
During the third quarter of 2024, the closing price of the Company’s common stock exceeded 130 % of the conversion price of the Notes for more than 20 trading days of the last 30 consecutive trading days of the quarter. As a result, the Notes are convertible at the option of the holders of the Notes during the fourth quarter of 2024, the quarter immediately following the quarter when the conditions are met, as stated in the terms of the Notes. In accordance with ASC 470-10, because the Notes are convertible, the Company reclassified the carrying value of the Notes from long-term debt, net and other borrowings to current portion of long-term debt, net and other borrowings on the Company’s condensed consolidated balance sheet as of September 30, 2024.
As of September 30, 2024, the carrying value of the Notes was $ 575.0 million, the Notes had an unamortized discount of zero , and the fair value of the liability was $ 892.4 million. The Company recorded interest expense of approximately $ 3.8 million and $ 11.3 million related to the Notes for the three and nine months ended September 30, 2024, respectively. There were no conversions of Notes during the nine months ended September 30, 2024.
12. Derivative Instruments
The Company has used, but does not currently use, interest rate swaps to reduce the variability in cash flows associated with portions of the Company’s interest payments on variable rate debt.
13. Accumulated Other Comprehensive Loss
The components of accumulated other comprehensive loss, net of tax of zero for the nine months ended September 30, 2024 and 2023 consisted of the following:
(in thousands) Foreign Currency Translation Accumulated Other Comprehensive (Loss) Income
Balance at January 1, 2024
$ ( 1,037 ) $ ( 1,037 )
Other comprehensive loss before reclassifications ( 129 ) ( 129 )
Balance at September 30, 2024
$ ( 1,166 ) $ ( 1,166 )
Balance at January 1, 2023
$ ( 1,259 ) $ ( 1,259 )
Other comprehensive income before reclassifications 224 224
Balance at September 30, 2023
$ ( 1,035 ) $ ( 1,035 )
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14. Stock-Based Compensation
The following table presents stock-based compensation expense recognized in the Company’s accompanying condensed consolidated statements of operations:
Three Months Ended
September 30, Nine Months Ended
September 30,
(in thousands) 2024 2023 2024 2023
Cost of goods sold $ 3,614 $ 2,508 $ 9,116 $ 6,381
Sales and marketing 3,813 2,823 9,681 7,044
General and administrative 9,926 6,741 27,457 17,813
Research and development 3,013 1,904 7,975 5,097
Total stock-based compensation expense $ 20,366 $ 13,976 $ 54,229 $ 36,335
15. Leases
Operating and finance lease assets and liabilities are as follows:
(in thousands) Classification September 30,
2024 December 31,
2023
Assets
Operating Other long-term assets $ 39,346 $ 45,325
Finance Property, plant and equipment, net 1,235 1,438
Total leased assets $ 40,581 $ 46,763
Liabilities
Current
Operating Accrued expenses and other liabilities $ 2,062 $ 1,904
Finance Current portion of long-term debt and other borrowings 996 823
Noncurrent
Operating Other long-term liabilities 53,915 54,453
Finance Long-term debt, net and other borrowings 613 625
Total leased liabilities $ 57,586 $ 57,805
On May 4, 2023, the Company entered into a modification to the operating lease (the “Bedford Lease”) for office space in Bedford, Massachusetts (the “Existing Premises”) that was executed in February 2022. The Bedford 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 included 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. On October 7, 2024, the Company executed a second amendment to the Bedford Lease for additional space.
On March 1, 2024, the Company transferred the sublease and completed the asset sale of the Somerset Facility. See Note 7, "Property, Plant and Equipment, Net" for further discussion on the sublease transfer.
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Other information related to leases were as follows:
September 30,
2024 December 31,
2023
Weighted-average remaining lease term (Years):
Operating leases 13.0 13.5
Finance leases 2.4 2.3
Weighted-average discount rate:
Operating leases 7.5 % 7.3 %
Finance leases 7.4 % 6.2 %
16. Net Income Per Common Share
A summary of net income per common share is presented below:
Three Months Ended
September 30, Nine Months Ended
September 30,
(in thousands, except per share amounts) 2024 2023 2024 2023
Net income $ 131,093 $ 131,957 $ 324,232 $ 223,281
Basic weighted-average common shares outstanding 69,464 68,436 69,193 68,188
Effect of dilutive stock options 352 320 273 366
Effect of dilutive restricted stock 1,580 1,290 1,309 1,449
Effect of convertible notes 1,669 — 556 265
Diluted weighted-average common shares outstanding 73,065 70,046 71,331 70,268
Basic income per common share $ 1.89 $ 1.93 $ 4.69 $ 3.27
Diluted income per common share $ 1.79 $ 1.88 $ 4.55 $ 3.18
Antidilutive securities excluded from diluted net income per common share 144 435 855 422
Impact of the Convertible Notes
The Company considered whether the Notes are participating securities through the two-class method. Per the terms of the Notes’ agreement, 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 earnings exceeds the current share price, regardless of whether such dividend is declared. During the three and nine months ended September 30, 2024 and 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 has 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. See Note 11, "Long-Term Debt, Net, and Other Borrowings" for further discussion on the Notes.
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17. Other Income
Other income consisted of the following:
Three Months Ended
September 30, Nine Months Ended
September 30,
(in thousands) 2024 2023 2024 2023
Foreign currency (gain) loss $ ( 46 ) $ 9 $ 192 $ 31
Tax indemnification income, net — 3,672 — 3,344
Interest income ( 9,801 ) ( 4,540 ) ( 27,273 ) ( 12,090 )
Gain on sale of RELISTOR licensed intangible asset associated with net sales royalties — ( 51,789 ) — ( 51,789 )
Other ( 106 ) ( 1 ) ( 704 ) 142
Total other income, net $ ( 9,953 ) $ ( 52,649 ) $ ( 27,785 ) $ ( 60,362 )
18. Commitments and Contingencies
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 condensed consolidated financial statements.
As of September 30, 2024, 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 the Company’s Abbreviated New Drug Application and Paragraph IV certification in connection with PNT2003, 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.
19. 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 was therefore treated as an asset acquisition.
In February 2023, the Company made an upfront payment of approximately $ 35.3 million to the Cerveau Stockholders and paid the Cerveau 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 Cerveau 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 Cerveau 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. The purchase agreement pursuant to which the Company purchased Cerveau specified, among other things, that certain Cerveau Stockholders provide transition and clinical development services for a prescribed time following the closing of the transaction.
On January 8, 2024, the Company entered into an agreement with Perspective to participate in the next qualified financing to purchase the Perspective Shares. On January 22, 2024, the Company purchased 56,342,355 Perspective Shares, representing 11.39 % of the outstanding Perspective Shares, at the fair market offering price of $ 0.37 per share. Included within the agreement is a covenant which allows for the Company to designate one observer to Perspective’s board of directors. The observer has the option to attend any or all board meetings in a nonvoting capacity and the right to receive any board materials, except under certain instances where
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attorney-client privilege is necessary, where the material relates to a business or contractual relationship with the Company, to avoid bona fide conflict of interest, exposure of trade secrets or relating to a change of control transaction. The Company also purchased 60,431,039 Perspective Shares at a fair market purchase price of $ 0.95 per share as an investor in a private placement transaction on March 6, 2024, which resulted in the Company holding a cumulative 19.90 % of the outstanding Perspective Shares (or 17.35 % on a fully diluted basis) after giving effect to the closing of the private placement transaction. The Company does not have the ability to exercise significant influence over operating and financial policies of Perspective because the Company’s board observer has no voting rights and there is otherwise no participation in policy-making processes, no interchange of managerial personnel, and no sharing of technology between the Company and Perspective.
Also effective January 8, 2024, the Company obtained the following options and rights from Perspective for an aggregate upfront payment of $ 28.0 million in cash:
• An exclusive option from Perspective to negotiate for an exclusive license under the rights of Perspective and its affiliates to Perspective’s Pb212-VMT-⍺-NET, a clinical stage alpha therapy developed for the treatment of neuroendocrine tumors, to develop, manufacture, commercialize and otherwise exploit the VMT-α-NET Product.
• A right to co-fund the investigational new drug application (“IND”) enabling studies for early-stage therapeutic candidates targeting prostate-specific membrane antigen and gastrin releasing peptide receptor and, prior to IND filing, a right to negotiate for an exclusive license to such candidates.
• A right of first offer and last look protections for any third party merger and acquisition transactions involving Perspective for a twelve-month period.
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 $ 28.0 million was recognized in research and development expenses during the three months ended March 31, 2024.
Also effective January 8, 2024, the Company entered into an agreement with Perspective to transfer the Somerset Facility and the associated assets at the Somerset Facility for $ 8.0 million. The transfer of the sublease and completion of the asset sale occurred on March 1, 2024 at which time the Company had no further continuing legal obligations related to the lease. See Note 7, "Property, Plant and Equipment, Net" for additional details.
On June 14, 2024 Perspective effected a 1-for-10 reverse stock split, after which the Company held 11,677,339 shares of Perspective’s common stock.
On June 15, 2024, the Company entered into an agreement with Radiopharm Theranostics Limited (“Radiopharm”) to acquire all of Radiopharm’s rights to two licensed preclinical assets for an upfront payment of $ 2.0 million. The Company acquired global exclusive rights to both an LRRC15-targeted monoclonal antibody referred to as DUNP19 and to a Trophoblast cell surface antigen 2 (“TROP2”)-targeted nanobody. LRRC15 is a potential first-in-class, highly specific monoclonal antibody radio-conjugate with both Orphan Drug and Rare Pediatric Disease designations from the FDA for the treatment of osteosarcoma. The agent is designed to target the surrounding tumor micro-environment cells expressing the protein potentially treating a broad range of cancers. The TROP2-targeted nanobody radio-conjugate is designed to target TROP2, an intracellular calcium signal transducer that is overexpressed in various types of adenocarcinomas with minimal expression in normal tissues and is associated with tumor aggressiveness, poor prognosis and drug resistance.
In connection with this acquisition, the Company assumed the underlying license agreements related to the two preclinical assets, together with their respective milestone and royalty payment obligations. The Company could pay up to an additional $ 20.0 million in milestone payments upon achievement of specified regulatory milestones. The Company could also pay up to an additional $ 6.5 million in sales milestone payments upon the achievement of specified annual commercial sales thresholds in the event the Company pursues commercialization as well as royalty payments for commercial sales. 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 $ 2.0 million was recognized in research and development expenses during the nine months ended September 30, 2024 related to the Radiopharm transaction.
The Company also entered an agreement with Radiopharm to make an initial equity investment of approximately $ 5.0 million to purchase 149,625,180 Radiopharm shares (the “Initial Shares”) at the fair market offering price of $ 0.03 per share upon the receipt of required approvals from Radiopharm’s shareholders, which were obtained during the third quarter of 2024. Included within the agreement is an option for the Company to invest an additional $ 5.0 million within six months of the issuance date of the Initial Shares on the same terms as the Company’s initial purchase, which would result in the Company purchasing approximately an additional 149,925,040 Radiopharm shares. No additional shares were purchased under the option during the three months ended September 30, 2024.
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On June 18, 2024, the Company acquired Meilleur, including its asset NAV-4694, an investigational F 18-labeled PET imaging agent that targets beta amyloids in Alzheimer’s disease. The Company determined that upon review of the Meilleur acquisition, the transaction did not meet the definition of a business combination and is therefore treated as an asset acquisition.
The Company made an upfront payment of approximately $ 32.9 million to the Meilleur Stockholders on June 18, 2024 and paid an additional $ 10.0 million in August 2024 after the successful completion of a technology transfer. The Company could pay up to an additional $ 43.0 million in milestone payments upon achievement of specified U.S. regulatory milestones related to NAV-4694. The Meilleur Stockholders are also eligible to receive up to $ 830.0 million in sales milestone payments upon the achievement of specified annual commercial sales thresholds of NAV-4694 in the event the Company pursues commercialization as well as up to $ 5.0 million in research milestones upon achievement of specified clinical studies at academic institutions thresholds. Research revenue is derived from existing partnerships with pharmaceutical companies and academic institutions that use NAV-4694 in clinical trials. Additionally, the Company could pay the Meilleur Stockholders up to double-digit royalty payments for research revenue and, in the event the Company pursues commercialization, commercial sales. Certain Meilleur Stockholders are providing transition and clinical development services for a prescribed time following the closing of the transaction for a fair market value fee.
On June 27, 2024, the Company announced it had acquired from Life Molecular Imaging Ltd. (“Life Molecular Imaging”) the global rights to RM2, a gastrin-releasing peptide receptor (“GRPR”)-targeting agent, including the associated novel, clinical-stage radiotherapeutic and radiodiagnostic pair, referred to as 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2, for an upfront payment of $ 35.0 million plus a $ 1.0 million payment made prior to the acquisition. The Company could pay up to an additional 132.5 million Euros in regulatory milestone payments upon achievement of clinical trial thresholds and approvals in different regions. The Company could pay up to 280.0 million Euros in sales milestone payments upon the achievement of specified annual commercial sales threshold of RM2 in the event the Company pursues commercialization. Additionally, the Company could pay up to 25.0 million Euros for collaboration payments inclusive of all costs including employee costs, payments due to certain universities, out-of-pocket expenses and services costs, as well as up to 5.0 million Euros for any additional development services performed by Life Molecular Imaging through July 3, 2026. 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 $ 36.0 million was recognized in research and development expenses during the nine months ended September 30, 2024 related to the Life Molecular Imaging acquisition. Global rights are exclusive for therapeutic fields in all countries and diagnostic fields in the Americas and co-exclusive with Life Molecular Imaging for diagnostic fields outside of the Americas.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.