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| Provision for excess and obsolete inventory | | | | | | | | |
| Stock-based compensation | | | | | | | | |
| Gain on disposal of assets | () | | | | | | () | |
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| Deferred taxes | () | | | () | | | | |
| Long-term indemnification receivable | | | | | | | | |
| Long-term income tax payable and other long-term liabilities | () | | | () | | | () | |
| Other | | | | | | | | |
| Changes in assets and liabilities which provided (used) cash: | | | | | |
| Accounts receivable | () | | | () | | | () | |
| Inventory | () | | | () | | | () | |
| Other current assets | () | | | () | | | () | |
| Other long-term assets | | | | () | | | | |
| Accounts payable | | | | | | | | |
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| Accrued expenses and other liabilities | () | | | | | | | |
| Net cash provided by operating activities | | | | | | | | |
| Investing activities | | | | | |
| Capital expenditures | () | | | () | | | () | |
| Proceeds from sale of assets, net | | | | | | | | |
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| Acquisition of assets | () | | | () | | | | |
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| Net cash provided by (used in) investing activities | | | | () | | | | |
| Financing activities | | | | | |
| Proceeds from issuance of common stock | | | | | | | | |
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| Debt issuance costs | | | | () | | | | |
| Proceeds from issuance of long-term debt, net | | | | | | | | |
| Contingent value rights settlement | () | | | | | | | |
| Payments on long-term debt and other borrowings | () | | | () | | | () | |
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| Deferred financing costs | | | | () | | | | |
| Proceeds from interest rate swap termination | | | | | | | | |
| Proceeds from stock option exercises | | | | | | | | |
| Payments for minimum statutory tax withholding related to net share settlement of equity awards | () | | | () | | | () | |
| Repurchase of common stock | | | | () | | | | |
| Net cash (used in) provided by financing activities | () | | | | | | () | |
| Effect of foreign exchange rates on cash and cash equivalents | () | | | () | | | () | |
| Net increase in cash and cash equivalents and restricted cash | | | | | | | | |
| Cash and cash equivalents and restricted cash, beginning of year | | | | | | | | |
| Cash and cash equivalents and restricted cash, end of year | $ | | | | $ | | | | $ | | |
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 | $ | | | | $ | | | | $ | | |
|
| Restricted cash included in other long-term assets | | | | | | | | |
| Cash, cash equivalents and restricted cash at end of period | $ | | | | $ | | | | $ | | |
| | | | | | | | | | | | | | | | | |
| Year Ended December 31, |
| 2023 | | 2022 | | 2021 |
| Supplemental disclosure of cash flow information | | | | | |
| Cash paid during the period for: | | | | | |
| Interest | $ | | | | $ | | | | $ | | |
Income taxes, net of refunds of $, $ and $, respectively | $ | | | | $ | | | | $ | | |
| Schedule of non-cash investing and financing activities | | | | | |
| Additions of property, plant and equipment included in liabilities | $ | | | | $ | | | | $ | | |
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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.
4.
| | $ | | | | $ | | | | $ | | | | |
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| Total assets | $ | | | | $ | | | | $ | | | | $ | | |
| Liabilities: | | | | | | | |
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| Contingent consideration liabilities | $ | | | | $ | | | | $ | | | | $ | | |
| Total liabilities | $ | | | | $ | | | | $ | | | | $ | | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | December 31, 2022 |
| (in thousands) | Total Fair Value | | Level 1 | | Level 2 | | Level 3 |
| Assets: | | | | | | | |
| Money market funds | $ | | | | $ | | | | $ | | | | $ | | |
| |
| |
| Total assets | $ | | | | $ | | | | $ | | | | $ | | |
| Liabilities: | | | | | | | |
| |
| Contingent consideration liabilities | $ | | | | $ | | | | $ | | | | $ | | |
| Total liabilities | $ | | | | $ | | | | $ | | | | $ | | |
| | | | | | | |
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 $ million upon regulatory approval and a % 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
% of U.S. net sales generated by PYLARIFY in 2022 and 2023 in excess of $ million and $ 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 $ million if the Company attains certain net sales targets primarily for AZEDRA and 1095 (also known as 131 I-MIP-1095) and a $ million 1095 commercialization milestone. Additionally, there is a potential payment of up to $ million related to a 1404 commercialization milestone. The Company’s total potential payments related to the 2013 Acquisition are approximately $ 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.
| | Probability adjusted discounted cash flow model | | Period of expected milestone achievement and sales targets | | N/A | | 2022 – 2023 | | | | | | | | Probability of success | | N/A | | | % |
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| 1095 commercialization milestone | | | | | | | Probability adjusted discounted cash flow model | | | | | | |
| | | | | | | Period of expected milestone achievement | | 2026 | | 2026 |
| | | | | | | Probability of success | | | % | | | % |
| | | | | | | Discount rate | | | % | | | % |
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| Net sales targets – AZEDRA and 1095 | | | | | | | Monte Carlo simulation | | | | | | |
| | | | | | | Probability of success and sales targets | | % - % | | % - % |
| | | | | | | Discount rate | | % | | % - % |
| Total | $ | | | | $ | | | | | | | | | | |
| | $ | | | | $ | | | | $ | | | | |
| Changes in fair value included in net income (loss) | | | | () | | | () | | | | |
| Cash Payments | | | | | | | () | | | | |
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| Fair value, end of period | $ | | | | $ | | | | $ | | | | $ | | |
| |
| | 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.
5.
| | $ | | | | $ | () | |
| International | | | | () | | | | |
| Income (loss) before income taxes | $ | | | | $ | | | | $ | () | |
| | $ | | | | $ | | | | State | | | | | | | () | |
| International | | | | () | | | () | |
| | | | | | | () | |
| Deferred | | | | | |
| Federal | () | | | () | | | | |
| State | () | | | () | | | | |
| International | | | | | | | | |
| () | | | () | | | | |
| Income tax expense (benefit) | $ | | | | $ | () | | | $ | () | |
| | $ | | | | $ | () | | | Permanent items | | | | | | | | |
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| Accretion expense | | |
| Balance, December 31, 2023 | $ | | |
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 $ million surety bond.
10.
– | Straight-Line | | $ | | | | $ | () | | | $ | | | | Customer relationships | – | | Accelerated | | | | | () | | | | |
| Currently marketed product | – | | Straight-Line | | | | | () | | | | |
| Licenses | – | | Straight-Line | | | | | () | | | | |
| Developed technology | | | Straight-Line | | | | | () | | | | |
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| Unamortized debt issuance costs | () | |
| Finance lease liabilities | | |
| Total | | |
| Less: current portion | () | |
| Total long-term debt, net, and other borrowings | $ | | |
In December 2022, the Company refinanced its existing credit facility, consisting of (i) a $ million term loan facility (the “2019 Term Facility”) and (ii) a $ million revolving credit facility (the “2019 Revolving Facility” and, together with the 2019 Term Facility, the “2019 Facility”), with a new $ million delayed draw term loan facility (the “2022 Term
million revolving credit facility (the “2022 Revolving Facility” and, together with the 2022 Term Facility, the “2022 Facility”).The Company used approximately $ 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 $ 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 $ 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 $ 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 $ million (the “Revolving Commitment”) at any time, including a $ million sub-facility for the issuance of letters of credit (the “Letters of Credit”) and a $ 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 % to % based on the Company’s total net leverage ratio or (ii) the alternative base rate plus an applicable margin that ranges from % to % based on the Company’s total net leverage ratio. The 2022 Revolving Facility also includes an unused commitment fee at a rate ranging from % to % 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 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 $ 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 financial covenants. The minimum interest coverage ratio, commencing with the fiscal quarter ended December 31, 2022, must be at least to 1.00. The maximum total net leverage ratio permitted by the financial covenant, commencing with the fiscal quarter ending March 31, 2024, is 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
million in aggregate principal amount of % Convertible Senior Notes due 2027 (the “Notes”), which includes $ 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 $ 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 % 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 $ per share of the Company’s common stock, representing an initial conversion premium of approximately % above the closing price of $ 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 % of the conversion price of the Notes for a specified period of time. The redemption price will be equal to % 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 % to % 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 385th 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) % to % 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 $ million, had an unamortized discount of , and the fair value of the liability was $ million. The Company recorded interest expense of approximately $ million related to the Notes for the year ended December 31, 2023.
13.
million through May 31, 2024. The average fixed LIBOR rate on the interest rate swaps was approximately %. 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 $ million in cash and the remaining balance of approximately $ million in accumulated other comprehensive income (loss) related to the interest rate swap contracts were reclassified into earnings.
14.
and 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 | $ | () | | | $ | | | | $ | () | |
| Other comprehensive income (loss) before reclassifications | | | | | | | | |
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))
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| Other Long-Term Assets | | | | | |
| Total other long-term assets | $ | | | | $ | | |
18.
| | $ | | | | $ | () | | | | | | | |
| Basic weighted-average common shares outstanding | | | | | | | | |
| Effect of dilutive stock options | | | | | | | | |
|
| Effect of dilutive restricted stock | | | | | | | | |
| Effect of convertible debt instrument | | | | | | | | |
| Diluted weighted-average common shares outstanding | | | | | | | | |
| | | | | |
| Basic income (loss) per common share | $ | | | | $ | | | | $ | () | |
| Diluted income (loss) per common share | $ | | | | $ | | | | $ | () | |
| | | | | |
| Antidilutive securities excluded from diluted net income (loss) per common share | | | | | | | | |
Impact of the Convertible Notes
per share.
19.
| | 2025 | | |
| 2026 | | |
| 2027 | | |
| 2028 and thereafter | | |
| Total | $ | | |
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 $ million in contingent payments under the Company’s license agreements. These
20.
million, $ million and $ million for the years ended December 31, 2023, 2022 and 2021, respectively.
21.
million to the stockholders of Cerveau (the “Selling Stockholders”) and paid the Selling Stockholders an additional $ million in May 2023 upon the successful completion of a technology transfer. The Company could pay up to an additional $ 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 $ 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 $ 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 $ million to POINT as a part of an asset acquisition with the potential for additional milestone payments of approximately $ 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 $ million, and could pay up to an additional $ 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 $ 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 $ million, and could pay up to an additional $ 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 $ 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 % for PNT2002 and % 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 $ million was recognized in research and development expenses during the year ended December 31, 2022.
22.
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.
million in cash; •Lantheus agreed to purchase up to % of Perspective’s outstanding shares of common stock for up to approximately $ 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.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Not applicable.
Item 9A. Controls and Procedures
Disclosure Controls and Procedures
The Company’s management, with the participation of the Company’s Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), its principal executive officer and principal financial officer, respectively, has evaluated the effectiveness of the Company’s disclosure controls and procedures as defined in Rule 13a-15(e) and 15d-15(e) of the Exchange Act. Based on that evaluation, the Company’s CEO and CFO concluded that the Company’s disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) were effective as of the period covered by this report.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management, with the participation of our CEO and CFO, is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our internal control system is designed to provide reasonable assurance to our management and Board of Directors regarding the preparation and fair presentation of published financial statements.
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2023. In making its assessment of internal control over financial reporting, our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework (2013). Based on this assessment, management concluded that, as of December 31, 2023, our internal control over financial reporting was effective.
Deloitte & Touche LLP, an independent registered public accounting firm that audited our financial statements for the fiscal year ended December 31, 2023, included in this report, has issued an attestation report on the effectiveness of our internal control over financial reporting. This report is set forth below:
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and the Board of Directors of Lantheus Holdings, Inc.
Opinion on Internal Control over Financial Reporting
We have audited the internal control over financial reporting of Lantheus Holdings, Inc. and subsidiaries (the “Company”) as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2023, of the Company and our report dated February 22, 2024, expressed an unqualified opinion on those financial statements.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Deloitte & Touche LLP
Boston, Massachusetts
February 22, 2024
Changes in Internal Controls Over Financial Reporting
There were no changes in our internal control over financial reporting for the quarter ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
We are continually monitoring and assessing the pandemic status and geopolitical environment to determine any potential impact on the design and operating effectiveness of our internal controls over financial reporting.
Item 9B.
, , a , into a trading plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act (a “10b5-1 Plan”), providing for the potential sale of up to shares of our common stock obtained from the exercise of vested stock options covered by the 10b5-1 Plan, between March 4, 2024 and May 15, 2024. On , Mr. Leno his 10b5-1 Plan to add the potential sale of up to additional shares of our common stock obtained from the exercise of vested stock options covered by the 10b5-1 Plan, between March 4, 2024 and May 15, 2024.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not Applicable.
PART III
Item 10. Directors, Executive Officers and Corporate Governance
Pursuant to Section 406 of the Sarbanes-Oxley Act of 2002, we have adopted a code of conduct and ethics (our “Code of Conduct”) for all of our employees, including our CEO, CFO and other senior financial officers, or persons performing similar functions, and each of the non-employee directors on our Board. Our Code of Conduct is currently available on our website, www.lantheus.com. The information on our web site is not part of, and is not incorporated into, this Annual Report on Form 10-K. We intend to provide any required disclosure of any amendment to or waiver from such code that applies to our CEO, CFO and other senior financial officers, or persons performing similar functions, in a Current Report on Form 8-K filed with the SEC.
The additional information required with respect to this item will be incorporated herein by reference to our Definitive Proxy Statement for our 2023 Annual Meeting of Stockholders or an amendment of this report to be filed with the SEC no later than 120 days after the close of our year ended December 31, 2023.
Item 11. Executive Compensation
The information required with respect to this item will be incorporated herein by reference to our Definitive Proxy Statement for our 2024 Annual Meeting of Stockholders or an amendment of this report to be filed with the SEC no later than 120 days after the close of our year ended December 31, 2023.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required with respect to this item will be incorporated herein by reference to our Definitive Proxy Statement for our 2024 Annual Meeting of Stockholders or an amendment of this report to be filed with the SEC no later than 120 days after the close of our year ended December 31, 2023.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required with respect to this item will be incorporated herein by reference to our Definitive Proxy Statement for our 2024 Annual Meeting of Stockholders or an amendment of this report to be filed with the SEC no later than 120 days after the close of our year ended December 31, 2023.
Item 14. Principal Accountant Fees and Services
The information required with respect to this item will be incorporated herein by reference to our Definitive Proxy Statement for our 2024 Annual Meeting of Stockholders or an amendment of this report to be filed with the SEC no later than 120 days after the close of our year ended December 31, 2023.
PART IV
Item 15. Exhibits and Financial Statement Schedules
(a)(1) Financial Statements
The following consolidated financial statements of Lantheus Holdings, Inc. are filed as part of this Annual Report on Form 10-K under Part II, Item 8. Financial Statements and Supplementary Data: (a)(2) Schedules
All schedules are omitted because they are not applicable, not required, or because the required information is included in the consolidated financial statements or notes thereto.
(a)(3) Exhibits
EXHIBIT INDEX | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Incorporated by Reference |
Exhibit Number | | Description of Exhibits | | Form | | File Number | | Exhibit | | Filing Date |
| | | | |
| | | | |
| 3.1 | | | | 8-K | | 001-36569 | | 3.1 | | April 27, 2018 |
| 3.2 | | | | 8-K | | 001-36569 | | 3.2 | | December 28, 2022 |
| 4.1 | | | | 8-K | | 001-36569 | | 4.1 | | June 30, 2015 |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| 4.2* | | | | | | | | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| 4.3 | | Indenture, dated as of December 8, 2022, between Lantheus Holdings, Inc., as Issuer, Lantheus Medical Imaging, Inc., as Guarantor, and U.S. Bank Trust Company, National Association, as Trustee | | 8-K | | 001-36569 | | 4.1 | | December 8, 2022 |
| 10.1+ | | | | S-4 | | 333-169785 | | 10.18 | | October 6, 2010 |
| 10.2+ | | | | S-4 | | 333-169785 | | 10.19 | | October 6, 2010 |
| 10.3+ | | | | S-4 | | 333-169785 | | 10.20 | | October 6, 2010 |
| 10.4+ | | | | S-4 | | 333-169785 | | 10.21 | | October 6, 2010 |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| 10.5+ | | | | 8-K | | 333-169785 | | 10.1 | | May 6, 2013 |
| 10.6+ | | | | 8-K | | 333-169785 | | 10.2 | | May 6, 2013 |
| 10.7+ | | | | 8-K | | 333-169785 | | 10.3 | | May 6, 2013 |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| 10.8+ | | | | S-1 | | 333-196998 | | 10.37 | | June 24, 2015 |
| 10.9+ | | | | S-1 | | 333-196998 | | 10.38 | | June 24, 2015 |
| 10.10+ | | | | S-1 | | 333-196998 | | 10.39 | | June 24, 2015 |
| 10.11+ | | | | S-1 | | 333-196998 | | 10.40 | | June 24, 2015 |
| 10.12+ | | | | S-1 | | 333-196998 | | 10.41 | | June 24, 2015 |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| 10.13+ | | | | 8-K | | 001-36569 | | 10.1 | | April 28, 2016 |
| 10.14+ | | | | 8-K | | 001-36569 | | 10.1 | | April 28, 2017 |
| 10.15+ | | | | 8-K | | 001-36569 | | 10.2 | | April 28, 2017 |
| | | | |
| 10.16† | | | | 10-Q | | 001-36569 | | 10.1 | | August 1, 2017 |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| 10.17+ | | | | 10-K | | 001-36569 | | 10.68 | | February 20, 2019 |
| 10.18+ | | | | 10-K | | 001-36569 | | 10.70 | | February 20, 2019 |
| 10.19+ | | | | 10-K | | 001-36569 | | 10.71 | | February 20, 2019 |
| 10.20+ | | | | 10-Q | | 001-36569 | | 10.1 | | April 30, 2019 |
| | | | |
| 10.21+ | | | | 10-Q | | 001-36569 | | 10.2 | | July 25, 2019 |
| | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Incorporated by Reference |
Exhibit Number | | Description of Exhibits | | Form | | File Number | | Exhibit | | Filing Date |
| 10.22+ | | | | S-8 | | 333-239491 | | 4.4 | | June 26, 2020 |
| 10.23+ | | | | S-8 | | 333-239491 | | 4.5 | | June 26, 2020 |
| 10.24 | | | | 8-K | | 000-23143 | | 10.46 (21) | | January 5, 2016 |
| 10.25+ | | | | 8-K | | 001-36569 | | 10 | | April 29, 2021 |
| 10.26†† | | | | 10-Q | | 001-36569 | | 10.1 | | April 29, 2022 |
| 10.27 | | | | 10-Q | | 001-36569 | | 10.2 | | April 29, 2022 |
| 10.28 | | | | 10-Q | | 001-36569 | | 10.3 | | April 29, 2022 |
| 10.29 | | | | 10-Q | | 001-36569 | | 10.4 | | April 29, 2022 |
| 10.30 | | | | 8-K | | 001-36569 | | 10.1 | | May 2, 2022 |
| 10.31†† | | | | 8-K | | 000-36569 | | 10.1 | | November 14, 2022 |
| 10.32 | | | | 8-K | | 001-36569 | | 10.1 | | December 5, 2022 |
| 10.33+ | | | | 8-K | | 001-36569 | | 10.1 | | May 1, 2023 |
| 10.34†† | | | | 10-Q | | 001-36569 | | 10.1 | | August 3, 2023 |
| 19.1* | |
| | | | | | | | |
| 21.1* | | | | | | | | | | |
| 23.1* | | | | | | | | | | |
| 24.1* | | | | | | | | | | |
| 31.1* | | | | | | | | | | |
| 31.2* | | | | | | | | | | |
| 32.1** | | | | | | | | | | |
| 97.1* | | | | | | | | | | |
| 101.INS* | | Inline XBRL Instance Document | | | | | | | | |
| 101.SCH* | | Inline XBRL Taxonomy Extension Schema Document | | | | | | | | |
| 101.CAL* | | Inline XBRL Taxonomy Extension Calculation Linkbase Document | | | | | | | | |
| 101.DEF* | | Inline XBRL Taxonomy Extension Definition Linkbase Document | | | | | | | | |
| 101.LAB* | | Inline XBRL Taxonomy Extension Labels Linkbase Document | | | | | | | | |
| 101.PRE* | | Inline XBRL Taxonomy Extension Presentation Linkbase Document | | | | | | | | |
| 104* | | Cover Page Interactive Data File (embedded within the Inline XBRL document) | | | | | | | | |
________________________________
* Filed herewith.
** Furnished herewith.
†† Portions of this exhibit have been omitted for confidential treatment pursuant to Item 601(b)(10)(iv) of Regulation S-K.
+ Indicates management contract or compensatory plan or arrangement.
† Confidential treatment requested as to certain portions, which portions have been filed separately with the Securities and Exchange Commission
Item 16. Form 10-K Summary
None.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| | | | | |
| LANTHEUS HOLDINGS, INC. |
| |
| By: | /S/ MARY ANNE HEINO |
| Name: | Mary Anne Heino |
| Title: | Chief Executive Officer |
| Date: | February 22, 2024 |
We, the undersigned directors and officers of Lantheus Holdings, Inc., hereby severally constitute and appoint Mary Anne Heino, Robert J. Marshall, Jr. and Daniel Niedzwiecki, and each of them individually, with full powers of substitution and resubstitution, our true and lawful attorneys, with full powers to them and each of them to sign for us, in our names and in the capacities indicated below, any and all amendments to this Annual Report on Form 10-K filed with the SEC, granting unto said attorneys-in-fact and agents, each acting alone, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming that any such attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. | | | | | | | | | | | | | | |
| Signature | | Title | | Date |
| | | | |
| /S/ MARY ANNE HEINO | | Chief Executive Officer and Director (Principal Executive Officer) | | February 22, 2024 |
| Mary Anne Heino | | | |
| | | | |
| /S/ ROBERT J. MARSHALL, JR. | | Chief Financial Officer and Treasurer (Principal Financial Officer) | | February 22, 2024 |
| Robert J. Marshall, Jr. | | | |
| | | | |
| /S/ ANDREA SABENS | | Chief Accounting Officer (Principal Accounting Officer) | | February 22, 2024 |
| Andrea Sabens | | | |
| | | | |
| /S/ BRIAN MARKISON | | Executive Chair of the Board of Directors | | February 22, 2024 |
| Brian Markison | | | |
| | | | |
| /S/ MINNIE BAYLOR-HENRY | | Director | | February 22, 2024 |
| Minnie Baylor-Henry | | | |
| | | | |
/S/ GÉRARD BER | | Director | | February 22, 2024 |
Gérard Ber | | | |
| | | | |
| /S/ SAMUEL R. LENO | | Director | | February 22, 2024 |
| Samuel R. Leno | | | |
| | | | |
/S/ HEINZ MÄUSLI | | Director | | February 22, 2024 |
Heinz Mäusli | | | |
| | | | |
| /S/ JULIE H. MCHUGH | | Director | | February 22, 2024 |
| Julie H. McHugh | | | |
| | | | |
| /S/ GARY J. PRUDEN | | Director | | February 22, 2024 |
| Gary J. Pruden | | | |
| | | | |
| /S/ DR. JAMES H. THRALL | | Director | | February 22, 2024 |
| Dr. James H. Thrall | | | |
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