Lantheus Holdings, Inc. 10-Q filed Nov 5, 2026

Modified · Cautionary Note Regarding Forward-Looking Statements

Some of the statements contained in this Quarterly Report on Form 10-Q (“Form 10-Q”) are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, 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 “anticipated,” “believes,” “can,” “commitment,” “could,” “designed,” “ensuring,” “estimates,” “expects,” “generate,” “impact,” “increasingly,” “hopes,” “intends,” “launch,” “likely,” “long-term,” “maintain,” “may,” “pending,” “pipeline,” “plans,” “potential,” “predict,” “proposed,” “remain,” “seek,” “should,” “sustain,” “target,” “will,” “would” and similar expressions, or by express or implied discussions regarding the pending Merger (as defined below), potential or pending acquisitions, dispositions, collaborations, development and commercialization plans described in this Form 10-Q, 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: (i) 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; (ii) our ability to complete the technology transfer across our positron emission tomography (“PET”) manufacturing facilities (“PMF”) network for PYLARIFY TruVu, the new formulation of our F-18 prostate-specific membrane antigen (“PSMA”) PET imaging agent approved by the U.S. Food and Drug Administration (“FDA”) on March 6, 2026, to obtain FDA approval for each PMF within our network to manufacture PYLARIFY TruVu, to obtainmaintain adequate coverage and payment for PYLARIFY TruVu, including the transitional pass-through payment status (“TPT Status”), granted by the Centers for PYLARIFY TruVuMedicare & Medicaid Services, as announced on September 30, 2026, to have payers add Healthcare Common Procedure Coding System (“HCPCS”) coding code for PYLARIFY TruVu effective October 1, 2026 to their systems on a timely basis and to have customers adopt PYLARIFY TruVu; (iii) 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, PYLARIFY TruVu, Neuraceq, MK-6240TAUKLARIFY, LNTH-2501 and NAV-4694; (iv) 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; (v) our ability to satisfy our obligations under our existing clinical development partnerships using Neuraceq, MK-6240 or NAV-4694 and other assets as a research tool and under the license agreements through which we have rights to those assets, to support TAUKLARIFY (florquinitau F-18 injection), also referred to as MK-6240, which was approved by the FDA on August 14, 2026, including through our Pharma Solutions business, and to further develop determine an appropriate path and commercialize MK-6240 timing toward its broader commercial availability, and to further develop and commercialize NAV-4694 as an approved productsproduct; (vi) our ability to continue to successfully integrate acquisitions, including of Lantheus Biosciences, which could be impacted by unforeseen expenses related to integration activities, the potential for unforeseen liabilities within that business, 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; (vii) our ability to obtain FDA approval for LNTH-2501, our investigational kit for the preparation of Gallium-68 (“Ga-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, including satisfactorily resolving certain unresolved third-party facility inspection-related conditions identified in the Complete Response Letter (“CRL”) issued by the FDA on June 26, 2026 and obtaining approval of a resubmitted New Drug Application (“NDA”), and to successfully commercialize LNTH-2501, if approved; (viii) the timing, execution and success of our ability to obtain final FDA approval for planned commercialization of BRAVNETSA (lutetium Lu 177 dotatate), previously known as PNT2003, which received final FDA tentative approval earlier this yearon September 22, 2026, including in light of competing lutetium Lu 177 dotatate products, our ability to successfully defend the favorable U.S. District Court ruling invalidating all patents asserted by ADACAPin the related Hatch-Waxman litigation, which is currently on appeal before the U.S. Court of Appeals for the Federal Circuit, and the timing, execution and success of the launch our dependence on POINT Biopharma Global Inc. to manufacture and commercialization of PNT2003, if approvedsupply BRAVNETSA; (ix) the cost, efforts and timing for clinical development, manufacturing, regulatory approval, adequate coding, coverage and payment and successful commercialization of our newly approved products, 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 has been obtained or is anticipated to be obtained this yearthe SPARROW Phase 2/3 registrational trial of LNTH-2401, and the risk of further impairment of our in-process research and development (“IPR&D”) assets; (x) the timing, execution, and success of our strategic program to simplify and streamline our operations so we can focus mainly on our radiodiagnostic business and pursue value-maximizing alternatives for our radiotherapeutic assets,; (xi) our ability to identify opportunities to collaborate with strategic partners and to acquire or in-license additional product opportunities in oncology, neurology and other strategic areas and continue to grow and advance our pipeline of products; (xii) , subject to the timing and outcome restrictions on the conduct of alleged stockholder actions filed against us; (xiii) our business under the effect that changes to managementAgreement and Plan of Merger, including the recent turnover in our leadership and senior management teamdated as of August 3, could have on our business; (xiv2026 (the “Merger Agreement”) our ability , by and the ability of among us, Curium US Holdings LLC to complete (the transactions contemplated by the “Parent”), and Coco Merger Agreement, including the parties’ ability to satisfy the closing conditions in the agreementSub Inc.; (xvxii) statements about the expected time frame for completing timing and outcome of the proposed acquisition ofactions filed against us by Curium US Holdings LLC; (xvi) our and Curium US Holdings LLC’s beliefs and expectations and statements aboutalleged stockholders, and of demands or litigation relating to the transactions contemplated by the Merger Agreement; (xiii) the benefits sought effect that changes to be achieved by the proposed acquisitionmanagement could have on our business; (xviixiv) the potential effects our ability and the ability of the proposed acquisition on us and Curium US Holdings LLC and (xviii)Parent to complete the transactions contemplated by the Merger Agreement, including the possibility of any termination of parties’ ability to satisfy the Merger Agreement.remaining closing conditions in