Lantheus Holdings Inc

LANTHEUS HOLDINGS, INC.

ANNUAL REPORT ON FORM 10-K

TABLE OF CONTENTS

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Some of the statements contained in this Annual Report on Form 10-K are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements, including, in particular, statements about our plans, strategies, prospects and industry estimates, are subject to risks and uncertainties. These statements identify prospective information and can generally be identified by words such as “anticipates,” “believes,” “can,” “could,” “designed,” “estimates,” “expects,” “hopes,” “intends,” “launch,” “may,” “pipeline,” “plans,” “potential,” “predicts,” “seeks,” “should,” “target,” “will,” “would” and similar expressions, or by express or implied discussions regarding potential marketing approvals or new indications for the product candidates or approved products described in this Annual Report on Form 10-K, or regarding potential future revenues from such product candidates and products. Examples of forward-looking statements include statements we make relating to our outlook and expectations including, without limitation, in connection with:

•Continued market expansion and penetration for our established commercial products, particularly PYLARIFY and DEFINITY, in a competitive environment in which other imaging agents have been approved and are being commercialized, and our ability to clinically and commercially differentiate our products;

•Our ability to have third parties manufacture our products and our ability to manufacture DEFINITY in our in-house manufacturing facility;

•The global availability of Molybdenum-99 (“Mo-99”) and other raw materials and key components;

•Our strategies, future prospects, and projected growth, including revenue related to our collaboration agreements with POINT Biopharma Global Inc. (“POINT”), including our ability to obtain FDA approval for PNT2002 and PNT2003;

•Our ability to satisfy our obligations under our existing clinical development partnerships using MK-6240 as a research tool and under the license agreement through which we have rights to MK-6240, and to further develop and commercialize it as an approved product;

•Our ability to successfully execute on our agreements with Perspective Therapeutics, Inc. (“Perspective”), including finalizing the license agreements in the event we exercise our options to do so, and satisfying the closing conditions for the sale of the Somerset, NJ manufacturing facility and related assets, the value of our current and any future equity interest in Perspective, and Perspective’s ability to successfully develop its alpha-particle therapy and innovative platform technology;

•The efforts and timing for clinical development, regulatory approval and successful commercialization of our product candidates and new clinical applications and territories for our products, in each case, that we or our strategic partners may undertake; and

•Our ability to identify and acquire or in-license additional radiopharmaceutical therapeutic and diagnostic product opportunities in oncology and other strategic areas to grow our pipeline of products.

Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, such statements are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. These statements are neither statements of historical fact nor guarantees or assurances of future performance. The matters referred to in the forward-looking statements contained in this Annual Report on Form 10-K may not in fact occur. We caution you, therefore, against relying on any of these forward-looking statements. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part I, Item 1A, "Risk Factors" in this Annual Report on Form 10-K.

Any forward-looking statement made by us in this Annual Report on Form 10-K speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

SUMMARY OF MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS

Our business is subject to a number of risks, including risks that may adversely affect our business, results of operations, cash flows, and prospects. These risks are discussed more fully below and include, but are not limited to, risks related to:

Risks Related to Our Portfolio of Commercial Products

•Our ability to continue to grow PYLARIFY including (A) the ability of positron emission tomography (“PET”) manufacturing facilities (“PMFs”) to manufacture PYLARIFY to meet product demand, (B) our ability to promote

PYLARIFY to customers, (C) our ability to obtain and maintain adequate coding, coverage, and payment for PYLARIFY, (D) our ability to maintain PYLARIFY as the leading prostate-specific membrane antigen (“PSMA”) PET imaging agent, including after the potential expiration of Transitional Pass-Through Payment Status (“TPT Status”) at the end of 2024, and (E) our ability to clinically and commercially differentiate PYLARIFY from other products.

•Our ability to continue to (A) grow the appropriate use of DEFINITY in suboptimal echocardiograms in a competitive environment and in the face of potential generic competition as a result of patent and regulatory exclusivity expirations, (B) maintain DEFINITY as the leading ultrasound enhancing agent, and (C) have third parties manufacture our products and our ability to manufacture the formulation of DEFINITY that requires refrigerated storage in our in-house manufacturing facility.

•Our dependence on a limited number of third party suppliers for Mo-99, which is a critical ingredient of TechneLite.

•Risks related to PYLCLARI, commercialized by Curium, including that the revenues generated for us thereby may not meet expectations.

Risks Related to Reimbursement and Regulation

•The dependence of many of our customers upon third party healthcare payors and the uncertainty of third party coverage and reimbursement rates.

•Uncertainties regarding the impact of U.S. and state healthcare reform measures and proposals on our business, including measures and proposals related to reimbursement for our current and potential future products, controls over drug pricing, drug pricing transparency, generic drug competition and the potential that efforts to extend or secure separate or otherwise adequate payment for radiopharmaceutical diagnostics are unsuccessful.

•Our being subject to extensive government regulation and oversight, our ability to comply with those regulations and the costs of compliance.

Risks Related to our Business Operations and Financial Results

•Our ability to hire or retain the number of qualified personnel, particularly scientific, medical and sales personnel, required for our business.

•Our ability to introduce new products and adapt to an evolving technology and medical practice landscape.

•Our ability to influence and manage the decision-making process with our collaboration partners, in particular where our partners are responsible for the performance of certain key tasks or functions, for example related to manufacturing or regulatory strategy, or where decisions may be controlled by, or subject to the approval of our collaboration partners, who may have views that differ from ours

Risks Related to Our and our Strategic Partners’ Portfolios of Clinical Development Candidates

•Risks associated with the development and commercialization of PNT2002, including (A) the outcome of the Phase 3 registrational clinical trial for PNT2002, which we refer to as SPLASH, after full data becomes available, (B) our ability to obtain regulatory approval for PNT2002; (C) the additional costs and risks associated with our ability to successfully launch PNT2002 as a commercial product; (D) the market and patient receptivity to PNT2002 as a radiopharmaceutical therapy; (E) the existence, availability and profile of competing products and therapies; (F) our ability to gain post-approval market acceptance and adequate coding, coverage and payment for PNT2002; and (G) POINT’s ability to successfully develop and scale the manufacturing capabilities to support the launch of PNT2002.

•Risks associated with the commercialization of PNT2003, including (A) the outcome of the patent infringement claim by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA, each a Novartis entity, in response to our filing of our Abbreviated New Drug Application (“ANDA”); (B) our ability to obtain regulatory approval for PNT2003, including the 180-day period of generic marketing exclusivity in the U.S. market as the “first applicant”, as provided under the Hatch-Waxman Act; (C) our ability to gain post-approval market acceptance and adequate coding, coverage and payment for PNT2003; and (D) POINT’s ability to successfully develop and scale the manufacturing capabilities to support the launch of PNT2003.

•Risks associated with MK-6240, including (A) our ability to satisfy our obligations under our existing clinical development partnerships using MK-6240 as a research tool and under the license agreement through which we have rights to MK-6240, and (B) our ability to further develop and commercialize it as an approved product, including obtaining regulatory approval and gaining post-approval market acceptance and adequate coding, coverage and payment.

•Risks associated with [18F] flurpiridaz (“flurpiridaz”), which we out-licensed to GE Healthcare Limited (“GE Healthcare”) in 2017, including GE Healthcare’s ability to (A) obtain regulatory approval, and (B) gain post-approval market acceptance and adequate coding, coverage and payment.

•Risks associated with our agreements with Perspective, including finalizing the license agreements in the event we exercise our options to do so, and satisfying the closing conditions for the sale of the Somerset, NJ manufacturing facility and related assets, the value of our current and any future equity interest in Perspective, and Perspective’s ability to successfully develop its alpha-particle therapy and innovative platform technology.

Risks Related to our Capital Structure

•Risks related to our outstanding indebtedness and our ability to satisfy those obligations, including the 2.625% Convertible Senior Notes due 2027 (the “Notes”).

•Risks related to the ownership of our common stock.

NOTE REGARDING COMPANY REFERENCES

Unless the context requires otherwise, references to “Lantheus,” “the Company,” “our company,” “we,” “us” and “our” refer to Lantheus Holdings, Inc. and, as the context requires, its direct and indirect subsidiaries; references to “Lantheus Holdings” refer to Lantheus Holdings, Inc.; references to “LMI” refer to Lantheus Medical Imaging, Inc., a wholly-owned subsidiary; references to “Cerveau,” “Lantheus Alpha,” “Lantheus Two,” “Lantheus Three” and “Progenics” refer to Cerveau Technologies, Inc.; Lantheus Alpha Therapy, 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.

NOTE REGARDING TRADEMARKS

We own or have the rights to various trademarks, service marks and trade names, including, among others, the following: PYLARIFY®, DEFINITY®, and Find Fight and Follow® referred to in this Annual Report on Form 10-K. Solely for convenience, we refer to trademarks and service marks in this Annual Report on Form 10-K without the TM, SM and ® symbols. Those references are not intended to indicate, in any way, that we will not assert, to the fullest extent permitted under applicable law, our rights to our trademarks and service marks. Each trademark, trade name or service mark of any other company appearing in this Annual Report on Form 10-K is, to our knowledge, owned by that other company.