Item 9A. Controls and Procedures
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, 2021. 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, 2021, 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, 2021, 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, 2021, 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, 2021, 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, 2021, of the Company and our report dated February 24, 2022, 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
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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 24, 2022
Changes in Internal Controls Over Financial Reporting
There were no changes in our internal control over financial reporting for the quarter ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
We are continually monitoring and assessing the status of the COVID-19 pandemic to determine any potential impact on the design and operating effectiveness of our internal controls over financial reporting.
Item 9B. Other Information
JHS Manufacturing and Supply Agreement
On February 23, 2022, our wholly-owned subsidiary, LMI, entered into a Manufacturing and Supply Agreement (the “MSA”) with JHS, effective as of February 23, 2022, pursuant to which JHS will manufacture, and LMI will purchase, our DEFINITY, NEUROLITE, Cardiolite and evacuation vial products. The new MSA supersedes all of the prior agreements of the parties. The initial term of the MSA runs through December 31, 2027 and can be further extended by mutual agreement of the parties. The MSA requires LMI to purchase from JHS specified percentages of its total requirements for DEFINITY, as well as specified quantities of NEUROLITE, Cardiolite and evacuation vial products, each year during the contract term. Either party can terminate the MSA upon the occurrence of certain events, including, but not limited to, the material breach or bankruptcy of the other party.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not Applicable.
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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 of Directors. 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 2022 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, 2021.
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 2022 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, 2021.
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 2022 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, 2021.
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 2022 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, 2021.
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 2022 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, 2021.
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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:
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 34)
77
Consolidated Balance Sheets
79
Consolidated Statements of Operations
80
Consolidated Statements of Comprehensive Income
81
Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
82
Consolidated Statements of Cash Flows
83
Notes to Consolidated Financial Statements
85
(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
2.1 Agreement and Plan of Merger, dated as of October 1, 2019, among Lantheus Holdings, Inc., Plato Merger Sub, Inc. and Progenics Pharmaceuticals, Inc.
8-K 001-36569 10.1 October 2, 2019
3.1 Amended and Restated Certificate of Incorporation of Lantheus Holdings, Inc.
8-K 001-36569 3.1 April 27, 2018
3.2 Amended and Restated Bylaws of Lantheus Holdings, Inc.
8-K 001-36569 3.2 December 27, 2021
4.1 Common Stock Certificate.
8-K 001-36569 4.1 June 30, 2015
4.2* Description of Registrant’s Securities
10.4+ Lantheus Holdings, Inc. 2008 Equity Incentive Plan.
S-4 333-169785 10.18 October 6, 2010
10.5+ Amendment No. 1 to Lantheus Holdings, Inc. 2008 Equity Incentive Plan.
S-4 333-169785 10.19 October 6, 2010
10.6+ Amendment No. 2 to Lantheus Holdings, Inc. 2008 Equity Incentive Plan.
S-4 333-169785 10.20 October 6, 2010
10.7+ Form of Option Grant Award Agreement.
S-4 333-169785 10.21 October 6, 2010
10.9† Manufacturing and Supply Agreement, dated as of February 1, 2012, for the manufacture of DEFINITY® by and between Lantheus Medical Imaging, Inc. and Jubilant HollisterStier LLC.
10-Q 333-169785 10.2 May 15, 2012
10.10† First Amendment to Manufacturing and Supply Agreement, dated as of May 3, 2012, for the manufacture of DEFINITY® by and between Lantheus Medical Imaging, Inc. and Jubilant HollisterStier LLC.
10-Q 333-169785 10.1 August 14, 2012
10.12+ Lantheus Holdings, Inc. 2013 Equity Incentive Plan.
8-K 333-169785 10.1 May 6, 2013
10.13+ Form of Employee Option Grant Award Agreement.
8-K 333-169785 10.2 May 6, 2013
10.14+ Form of Non-Employee Director Option Grant Award Agreement.
8-K 333-169785 10.3 May 6, 2013
10.15+ 2015 Equity Incentive Plan of Lantheus Holdings, Inc.
S-1 333-196998 10.37 June 24, 2015
10.16+ Form of 2015 Restricted Stock Agreement of Lantheus Holdings, Inc.
S-1 333-196998 10.38 June 24, 2015
10.17+ Form of 2015 Option Award Agreement of Lantheus Holdings, Inc.
S-1 333-196998 10.39 June 24, 2015
10.18+ Form of Amendment to the Lantheus Holdings, Inc. 2013 Equity Incentive Plan.
S-1 333-196998 10.40 June 24, 2015
10.19+ Form of Amendment to the Lantheus Holdings, Inc. 2008 Equity Incentive Plan.
S-1 333-196998 10.41 June 24, 2015
10.20+ Amendment to Lantheus Holdings, Inc. 2015 Equity Incentive Plan.
8-K 001-36569 10.1 April 28, 2016
10.21† Second Amendment, effective September 2, 2016, to the Manufacturing and Supply Agreement, dated as of February 1, 2012 and amended on May 3, 2012, by and between Lantheus Medical Imaging, Inc. and Jubilant HollisterStier LLC.
10-Q 001-36569 10.2 November 1, 2016
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Incorporated by Reference
Exhibit
Number Description of Exhibits Form File Number Exhibit Filing Date
10.22+ Second Amendment to Lantheus Holdings, Inc. 2015 Equity Incentive Plan
8-K 001-36569 10.1 April 28, 2017
10.23+ Lantheus Holdings, Inc. 2017 Employee Stock Purchase Plan
8-K 001-36569 10.2 April 28, 2017
10.24† Collaboration and License Agreement by and between Lantheus Medical Imaging, Inc. and GE Healthcare Limited dated April 25, 2017.
10-Q 001-36569 10.1 August 1, 2017
10.25+ Second Amended and Restated Employment Agreement, effective January 25, 2019, by and between Lantheus Medical Imaging, Inc. and Mary Anne Heino.
10-K 001-36569 10.68 February 20, 2019
10.26+ Employment Agreement dated as of November 22, 2013, by and between Lantheus Medical Imaging, Inc. and Michael Duffy.
10-K 001-36569 10.69 February 20, 2019
10.27+ Form of Severance Agreement (executives with existing employment agreements).
10-K 001-36569 10.70 February 20, 2019
10.28+ Form of Severance Agreement (executives without existing employment agreements).
10-K 001-36569 10.71 February 20, 2019
10.29+ Third Amendment to Lantheus Holdings, Inc. 2015 Equity Incentive Plan
10-Q 001-36569 10.1 April 30, 2019
10.30+ Fourth Amendment to Lantheus Holdings, Inc. 2015 Equity Incentive Plan
10-Q 001-36569 10.2 July 25, 2019
10.31 Credit Agreement dated as of June 27, 2019 by and among Wells Fargo Bank, N.A., as administrative agent and collateral agent, each of the lenders from time to time party thereto, Lantheus Medical Imaging, Inc., as borrower, and Lantheus Holdings, Inc.
10-Q 001-36569 10.3 July 25, 2019
10.32 Amendment No. 1 to Credit Agreement, dated as of June 19, 2020, among Lantheus Medical Imaging, Inc., as borrower, Lantheus Holdings, Inc. and Wells Fargo Bank, N.A., as administrative agent and collateral agent*
10-Q 001-36539 10.2 July 31, 2020
10.33 Contingent Value Rights Agreement dated as of June 19, 2020, by and between Lantheus Holdings, Inc. and Computershare Trust Company, N.A., as rights agent.
8-K 001-36569 10.1 June 22, 2020
10.34+ Lantheus Holdings, Inc. 2005 Stock Incentive Plan (f/k/a Progenics Pharmaceuticals, Inc. 2005 Stock Incentive Plan).
S-8 333-239491 4.4 June 26, 2020
10.35+ Lantheus Holdings, Inc. 2018 Performance Incentive Plan (f/k/a Progenics Pharmaceuticals, Inc. 2018 Performance Incentive Plan).
S-8 333-239491 4.5 June 26, 2020
10.36 License Agreement, dated February 3, 2011, by and between Salix Pharmaceuticals, Inc., the Registrant, Progenics Pharmaceuticals Nevada, Inc. and Excelsior Life Sciences Ireland Limited.
10-Q 000-23143 10.37(16) May 10, 2011
10.37 Lease, dated December 31, 2015, between the Registrant and WTC TOWER 1 LLC.
8-K 000-23143 10.46 (21) January 5, 2016
10.38+ Consulting Agreement by and between Lantheus Medical Imaging, Inc. and Michael P. Duffy, dated as of March 31, 2021
8-K 001-36569 10.1 April 1, 2021
10.39+ Fifth Amendment to Lantheus Holdings, Inc. 2015 Equity Incentive Plan
8-K 001-36569 10 April 29, 2021
21.1* Subsidiaries of Lantheus Holdings, Inc.
23.1* Consent of Independent Registered Public Accounting Firm.
24.1* Power of Attorney (included as part of the signature page hereto).
31.1* Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a).
31.2* Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).
32.1** Certification pursuant to 18 U.S.C. Section 1350.
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
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Item 16. Form 10-K Summary
None.
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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: President and Chief Executive Officer
Date: February 24, 2022
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, President and Director
(Principal Executive Officer) February 24, 2022
Mary Anne Heino
/S/ ROBERT J. MARSHALL, JR. Chief Financial Officer and Treasurer
(Principal Financial Officer) February 24, 2022
Robert J. Marshall, Jr.
/S/ ANDREA SABENS Chief Accounting Officer
(Principal Accounting Officer) February 24, 2022
Andrea Sabens
/S/ BRIAN MARKISON Chairman of the Board of Directors February 24, 2022
Brian Markison
/S/ GÉRARD BER
Director February 24, 2022
Gérard Ber
/S/ SAMUEL R. LENO Director February 24, 2022
Samuel R. Leno
/S/ HEINZ MÄUSLI
Director February 24, 2022
Heinz Mäusli
/S/ JULIE H. MCHUGH Director February 24, 2022
Julie H. McHugh
/S/ GARY J. PRUDEN Director February 24, 2022
Gary J. Pruden
/S/ DR. JAMES H. THRALL Director February 24, 2022
Dr. James H. Thrall
127