Lantheus Holdings, Inc.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Some of the statements contained in this Annual Report on Form 10-K (“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,” “commitment,” “could,” “designed,” “ensuring,” “estimates,” “expects,” “generate,” “impact,” “increasing,” “hopes,” “intends,” “launch,” “likely,” “long-term,” “maintain,” “may,” “pipeline,” “plans,” “potential,” “predict,” “remain,” “seek,” “should,” “sustain,” “target,” “will,” “would” and similar expressions, or by express or implied discussions regarding potential acquisitions, dispositions, collaborations, development and commercialization plans described in this Form 10-K, or regarding potential future revenues and expenses related to such acquisitions, collaborations, development and commercialization plans. Examples of forward-looking statements include statements we make relating to our outlook and expectations including, without limitation, in connection with:

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Continued market expansion, penetration and reimbursement for our established commercial products, particularly PYLARIFY, DEFINITY and Neuraceq, in a competitive environment, and our ability to clinically and commercially differentiate our products;

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Our ability to obtain U.S. Food and Drug Administration (“FDA”) approval for our new formulation of our F-18 prostate-specific membrane antigen (“PSMA”) positron emission tomography (“ PET”) imaging agent, to complete the technology transfer across our PET manufacturing facilities (“PMF”) network for such new formulation, to obtain FDA approval for each PET manufacturing facility to manufacture the new formulation, to obtain adequate coding, coverage and payment, including transitional pass-through payment status (“TPT Status”), for such new formulation and to have customers adopt such new formulation;

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The availability of raw materials, key components, equipment, manufacturing time slots, either used in the production of our products and product candidates, or by customers of our products and product candidates, including, but not limited to PET scanners for PYLARIFY, Neuraceq, MK-6240, LNTH-2501 and NAV-4694;

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Our ability to have third parties manufacture our products and product candidates and our ability to manufacture DEFINITY in our in-house manufacturing facility, in amounts and at the times needed;

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Our ability to satisfy our obligations under our existing clinical development partnerships using Neuraceq, MK-6240 or NAV-4694 as a research tool and under the license agreements through which we have rights to those assets, and to further develop and commercialize MK-6240 and NAV-4694 as approved products;

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Our ability to continue to successfully integrate acquisitions, including of Life Molecular Imaging Limited (“Life Molecular”) and Evergreen Theragnostics, Inc. (“Evergreen”), which could be impacted by unforeseen expenses related to integration activities, the accuracy of our financial models, the potential for unforeseen liabilities within those businesses, the ability to integrate disparate information technology systems, retain key talent and create a merged corporate culture that successfully realizes the full potential of the combined organization;

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Our ability to obtain FDA approval for LNTH-2501, our investigational kit for the preparation of Gallium-68 edotreotide injection, which has been studied for use in conjunction with a PET scan to stage and localize neuroendocrine tumors in adult and pediatric patients, and approval for PNT2003, and to be successful in the patent litigation associated with PNT2003;

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The cost, efforts and timing for clinical development, manufacturing, regulatory approval, adequate coding, coverage and payment, 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, including those investigational assets for which FDA approval is anticipated this year;

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Our ability to identify opportunities to collaborate with strategic partners and to acquire or in-license additional diagnostic and therapeutic product opportunities in oncology, neurology and other strategic areas and continue to grow and advance our pipeline of products; and

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The effect that changes to management, including the recent turnover in our leadership and senior management team, could have on our business.

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 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" of this Form 10-K.

Any forward-looking statement made by us in this 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 Our Portfolio of Commercial Products

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The continued substantial revenue contribution from PYLARIFY is dependent on (A) the ability of PMFs to manufacture PYLARIFY to meet product demand, including ensuring that PYLARIFY is available at the specific time of day preferred by the end-user, (B) our ability to ensure adequate coding, coverage, and payment for PYLARIFY, (C) our ability to promote PYLARIFY to customers and to maintain PYLARIFY as a widely utilized PSMA PET imaging agent, which has been impacted by the expiration of TPT Status on December 31, 2024, (D) whether and when a potential generic version of PYLARIFY may enter the market and (E) our ability to clinically and commercially differentiate PYLARIFY from competitive products.

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Our ability to continue to (A) grow the appropriate use of DEFINITY in suboptimal echocardiograms in a competitive environment, (B) mitigate the risk of generic competition as a result of patent and regulatory exclusivity expirations, (C) maintain DEFINITY as the most utilized ultrasound enhancing agent, and (D) have third parties manufacture our products and our ability to manufacture DEFINITY in our in-house manufacturing facility.

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Our ability to grow Neuraceq is dependent on (A) our ability to engage our existing PYLARIFY customers to introduce Neuraceq to those customers, (B) expanded geographical access to Neuraceq, which in turn depends on our ability to increase Neuraceq manufacturing capacity at existing manufacturing sites and add additional sites, (C) increased adoption and utilization of beta-amyloid PET and anti-amyloid therapeutics, (D) increased utilization based on the updated Neuraceq prescribing information indicating that Neuraceq can be used for patient selection for anti-amyloid therapies where the prescribing information for the therapy so states, (E)our ability to educate customers on the approved uses of Neuraceq, including its ability to quantify the degree of amyloid burden in the brain and (F) our ability to clinically differentiate Neuraceq from competitive products so that customers choose Neuraceq for appropriate patients because of its clinical attributes and despite the disparity in MUC payment rates for Neuraceq compared to other products used for traditional Medicare patients in the hospital outpatient setting.

Risks Related to Reimbursement and Regulation

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

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Uncertainties regarding the impact of federal 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.

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The extensive government regulation and oversight we and our business partners, suppliers and contract manufacturers are subject to, the ability to comply with those regulations and the costs of compliance, including costs to comply with new regulations or changes to the interpretation of existing regulations.

Risks Related to Our Business Operations and Financial Results

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Changes to management, including the recent turnover in our leadership and senior management team, could have an adverse effect on our business.

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

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Our ability, and our business partners’ abilities, to defend against any claims that we, or our partners, have infringed, misappropriated or otherwise violated the patent or other intellectual property rights of a third party.

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Our ability to continue to generate substantial revenue from PYLARIFY and to successfully launch new products, including our PET diagnostic products, such as the new formulation of our PSMA PET imaging agent, MK-6240,

LNTH-2501 and NAV-4694, is and will be dependent upon the availability of staff at imaging centers and hospitals and PET scanners generally.

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Our ability to continue to successfully integrate acquisitions, including of Life Molecular and Evergreen, which could be impacted by unforeseen expenses related to integration activities, the accuracy of our financial models, the potential for unforeseen liabilities within those businesses, the ability to integrate disparate information technology systems, retain key talent and create a merged corporate culture that successfully realizes the full potential of the combined organization.

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

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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 our own.

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Our use of artificial intelligence or other emerging technologies could adversely affect our business, results of operations, financial condition and cash flows.

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

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Risks associated with the commercialization of the new formulation of our PSMA PET imaging agent, including (A) our ability to obtain regulatory approval for the new formulation; (B) our ability to gain post-approval market acceptance and adequate coding, coverage, and payment for the new formulation, including TPT Status; (C) our manufacturer’s ability to successfully develop and scale the manufacturing capabilities to support the launch of the new formulation and to obtain FDA approval for each manufacturing site; (D) our ability to launch the new formulation to our customers on the timeline and under the terms and conditions currently anticipated; and (E) that we will be able to realize the anticipated increase in batch size or other expected improvements associated with the design of the new formulation or that such improvements will be viewed in the market as differentiating factors.

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Risks associated with the commercialization of our diagnostic product candidates, MK-6240, NAV-4694 and LNTH-2620, to be used in diagnosing, staging and monitoring Alzheimer’s disease, including (A) our ability to satisfy our obligations under our existing clinical development partnerships using those product candidates as a research tool; (B) disagreements with the counterparties to our license agreements for MK-6240, NAV-4694 or LNTH-2620 or the former stockholders of the companies we acquired who could receive future milestone and royalty-based payments, including disagreements that could arise over proprietary rights, contract interpretation or the preferred course of product research, development or marketing; and (C) our ability to further develop and commercialize MK-6240, NAV-4694 or LNTH-2620 as approved products, including obtaining regulatory approval and gaining post-approval market acceptance and adequate coding, coverage, and payment.

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Risks associated with the commercialization of LNTH-2501, including (A) our ability to obtain regulatory approval for LNTH-2501; (B) our ability to gain post-approval market acceptance and adequate coding, coverage, and payment for LNTH-2501; and (C) our manufacturer’s ability to successfully develop and scale the manufacturing capabilities to support the launch of LNTH-2501.

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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; (B) our ability to obtain regulatory approval for PNT2003; (C) our ability to gain post-approval market acceptance and adequate coding, coverage, and payment for PNT2003; and (D) POINT Biopharma Global Inc.’s ability to successfully develop and scale the manufacturing capabilities to support the launch of PNT2003.

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Risks associated with our agreements with Perspective Therapeutics, Inc. (“Perspective”), including finalizing the license agreements in the event we exercise our options to do so, 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.

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Risks associated with the development of our pipeline assets, including (A) under agreements with third parties such as the license and collaboration agreement for LNTH-2401 and LNTH-2402 relating to RM2, (B) the development of LNTH-2403 and LNTH-2404, the associated investment in Radiopharm Theranostics Limited (“Radiopharm”) and our co-development partnership with Radiopharm relating to the clinical development of our innovative products and product candidates in Australia.

Risks Related to Our Capital Structure

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Repurchases by us of our common stock may affect the value of our common stock and reduce cash available for other purposes.

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Risks related to our outstanding indebtedness and our ability to satisfy those obligations, including the 2.625% Convertible Senior Notes due December 2027.

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Risks related to the ownership of our common stock.

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Risks related to pending or future securities litigation or claims that we have otherwise engaged in wrongdoing.

NOTE REGARDING COMPANY REFERENCES

Unless the context otherwise requires, references to the “Company,” “our Company,” “Lantheus,” “we,” “us” and “our” 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 “Lantheus Medical” refer to Lantheus Medical Imaging, Inc., the wholly-owned subsidiary of Lantheus Holdings; references to “Aphelion,” “Lantheus Alpha” and “Meilleur” refer to Aphelion LLC, Lantheus Alpha Therapy, LLC and Meilleur Technologies, Inc., respectively, each a wholly-owned subsidiary of Lantheus Holdings; references to “Cerveau,” “Lantheus Real Estate,” “Progenics,” “Evergreen,” “Lantheus Radiopharm UK”, and “Lantheus Switzerland,” refer to Cerveau Technologies, Inc.; Lantheus MI Real Estate, LLC; Progenics Pharmaceuticals, Inc.; Evergreen Theragnostics, Inc.; Lantheus Radiopharmaceuticals UK Limited and Lantheus Switzerland GmbH, respectively, each a wholly-owned subsidiary of Lantheus Medical, references to “EXINI” refer to EXINI Diagnostics AB, a wholly-owned subsidiary of Progenics, and references to “Life Molecular” refer to Life Molecular Imaging Limited (now renamed as Lantheus Biosciences Ltd.), a wholly-owned subsidiary of Lantheus Radiopharm UK.

NOTE REGARDING TRADEMARKS

We own or have the rights to various trademarks, service marks and trade names, including, among others, the following: PYLARIFY®, DEFINITY®, Neuraceq® and Find Fight and Follow® referred to in this Form 10-K. Solely for convenience, we refer to trademarks and service marks in this 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 Form 10-K is, to our knowledge, owned by that other company.