# Lantheus Holdings, Inc.: Form 10-Q for the period ended Jun 30, 2025 - Company: [Lantheus Holdings, Inc.](/companies/lnth.md) (CIK 1521036) - Form: 10-Q - Filed: 2025-08-06 - Accepted by EDGAR: Aug 6, 2025, 07:51 ET - Period: 2025-06-30 - Accession: 0000950170-25-103544 - Inline XBRL: yes - Main document: https://www.sec.gov/Archives/edgar/data/1521036/000095017025103544/lnth-20250630.htm - All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1521036/000095017025103544/ ## Figures reported in this filing Standardized XBRL line items for the period ended 2025-06-30. | Line item | Period | Value | XBRL concept | | --- | --- | ---: | --- | | Revenue | 3 months, 2025-04-01 to 2025-06-30 | $378.0m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax | | Revenue | 6 months, 2025-01-01 to 2025-06-30 | $750.8m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax | | Cost of revenue | 3 months, 2025-04-01 to 2025-06-30 | $137.0m | us-gaap:CostOfGoodsAndServicesSold | | Cost of revenue | 6 months, 2025-01-01 to 2025-06-30 | $272.1m | us-gaap:CostOfGoodsAndServicesSold | | Gross profit | 3 months, 2025-04-01 to 2025-06-30 | $241.0m | us-gaap:GrossProfit | | Gross profit | 6 months, 2025-01-01 to 2025-06-30 | $478.7m | us-gaap:GrossProfit | | Research and development | 3 months, 2025-04-01 to 2025-06-30 | $45.5m | us-gaap:ResearchAndDevelopmentExpense | | Research and development | 6 months, 2025-01-01 to 2025-06-30 | $81.8m | us-gaap:ResearchAndDevelopmentExpense | | Operating income | 3 months, 2025-04-01 to 2025-06-30 | $88.0m | us-gaap:OperatingIncomeLoss | | Operating income | 6 months, 2025-01-01 to 2025-06-30 | $190.0m | us-gaap:OperatingIncomeLoss | | Interest expense | 3 months, 2025-04-01 to 2025-06-30 | $4.9m | us-gaap:InterestExpenseNonoperating | | Interest expense | 6 months, 2025-01-01 to 2025-06-30 | $9.7m | us-gaap:InterestExpenseNonoperating | | Income tax | 3 months, 2025-04-01 to 2025-06-30 | $25.8m | us-gaap:IncomeTaxExpenseBenefit | | Income tax | 6 months, 2025-01-01 to 2025-06-30 | $49.3m | us-gaap:IncomeTaxExpenseBenefit | | Net income | 3 months, 2025-04-01 to 2025-06-30 | $78.8m | us-gaap:NetIncomeLoss | | Net income | 6 months, 2025-01-01 to 2025-06-30 | $151.7m | us-gaap:NetIncomeLoss | | Diluted EPS | 3 months, 2025-04-01 to 2025-06-30 | $1.12 | us-gaap:EarningsPerShareDiluted | | Diluted EPS | 6 months, 2025-01-01 to 2025-06-30 | $2.14 | us-gaap:EarningsPerShareDiluted | | Basic EPS | 3 months, 2025-04-01 to 2025-06-30 | $1.15 | us-gaap:EarningsPerShareBasic | | Basic EPS | 6 months, 2025-01-01 to 2025-06-30 | $2.21 | us-gaap:EarningsPerShareBasic | | Diluted shares (weighted) | 3 months, 2025-04-01 to 2025-06-30 | 70,312,000 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding | | Diluted shares (weighted) | 6 months, 2025-01-01 to 2025-06-30 | 70,896,000 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding | | Operating cash flow | 6 months, 2025-01-01 to 2025-06-30 | $194.7m | us-gaap:NetCashProvidedByUsedInOperatingActivities | | Share repurchases | 6 months, 2025-01-01 to 2025-06-30 | $100.0m | us-gaap:PaymentsForRepurchaseOfCommonStock | | Cash and equivalents | at 2025-06-30 | $695.6m | us-gaap:CashAndCashEquivalentsAtCarryingValue | | Current assets | at 2025-06-30 | $1.20bn | us-gaap:AssetsCurrent | | Total assets | at 2025-06-30 | $2.12bn | us-gaap:Assets | | Current liabilities | at 2025-06-30 | $280.1m | us-gaap:LiabilitiesCurrent | | Total liabilities | at 2025-06-30 | $949.3m | us-gaap:Liabilities | | Current portion of debt | at 2025-06-30 | $796.0k | us-gaap:LongTermDebtCurrent | | Shareholders' equity | at 2025-06-30 | $1.17bn | us-gaap:StockholdersEquity | ## Management's discussion and analysis As filed, 71,581 characters. ### 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 “anticipates,” “believes,” “can,” “commitment,” “could,” “designed,” “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 or pending acquisitions, dispositions, collaborations, development and commercialization plans described in this Form 10-Q, or regarding potential future revenues and expenses from 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 and penetration for our established commercial products, particularly PYLARIFY and DEFINITY, in a competitive environment and our ability to clinically and commercially differentiate our products; (ii) our ability to have third parties manufacture our products and our ability to manufacture DEFINITY in our in-house manufacturing facility, in amounts and at the times needed; (iii) the availability of raw materials, key components, and equipment, either used in the production of our products and product candidates, or in the use by healthcare professionals (“HCPs”) of our products and product candidates, including, but not limited to positron emission tomography (“PET”) scanners for PYLARIFY, MK-6240 and NAV-4694; (iv) our ability to satisfy our obligations under our existing clinical development partnerships using MK-6240 or NAV-4694 as a research tool and under the license agreements through which we have rights to MK-6240 and NAV-4694, and to further develop and commercialize MK-6240 and NAV-4694 as approved products, including the timing for any potential regulatory submissions for these investigational assets; (v) our ability to successfully integrate acquisitions, including of Life Molecular Imaging Ltd. (“Life Molecular”) and Evergreen Theragnostics, Inc. (“Evergreen”), including the potential for 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; (vi) our ability to obtain U.S. Food and Drug Administration ("FDA") approval for our new formulation of our F-18 PSMA PET imaging agent, to complete the technology transfer across our PMF network for such new formulation, and to obtain adequate coding, coverage and payment, including transitional pass-through payment status (“TPT Status”), for such new formulation; (vii) our ability to complete the sale of our single-photon emission computerized tomography ("SPECT") business to SHINE Technologies, LLC ("SHINE"), a wholly-owned subsidiary of Illuminated Holdings, Inc. on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to securing the necessary regulatory approvals and satisfaction of other closing conditions to consummate the transaction, unforeseen expenses related to the divestiture, and failure to realize the expected benefits of the transaction; (viii) our ability to obtain FDA approval for LNTH-2501, our investigational kit for the preparation of Gallium-68 DOTATOC, which may be used in conjunction with a PET scan to stage and localize gastroenteropancreatic neuroendocrine tumors in adults and children, and approval for PNT2003, and to be successful in the patent litigation associated with PNT2003; (ix) the cost, efforts and timing for clinical development, 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; and (x) 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. 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-Q 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 our Annual Report on Form 10-K (“Form 10-K”) for the year ended December 31, 2024, and in Part II, Item 1A. “*Risk Factors”* in this Form 10-Q. Any forward-looking statement made by us in this Form 10-Q 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. ### Available Information Our global Internet site is www.lantheus.com. We routinely make available important information, including copies of our Form 10-K, Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after those reports are electronically filed with, or furnished to, the Securities and Exchange Commission (“SEC”), free of charge on our website at investor.lantheus.com. We recognize our website as a key channel of distribution to reach public investors and as a means of disclosing material non-public information to comply with our disclosure obligations under SEC Regulation FD. Information contained on our website shall not be deemed incorporated into, or to be part of this Form 10-Q, and any website references are not intended to be made through active hyperlinks. Our reports filed with, or furnished to, the SEC are also available on the SEC’s website at www.sec.gov, and for Form 10-Ks and Form 10-Qs, in an Inline Extensible Business Reporting Language (“iXBRL”) format. iXBRL is an electronic coding language used to create interactive financial statement data over the Internet. The information on our website is neither part of nor incorporated by reference into this Form 10-Q. The following discussion and analysis of our financial condition and results of operations should be read together with the condensed consolidated financial statements and the related notes included in Item 1 of this Form 10-Q as well as the other factors described in Part I, Item 1A. “*Risk Factors”* in our Form 10-K for the year ended December 31, 2024, and in Part II, Item 1A. “*Risk Factors”* in this Form 10-Q. ### Overview ### Our Business We are the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes. We classify our revenues into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. Our leading Radiopharmaceutical Oncology products help HCPs Find, Fight and Follow cancer. Our leading Precision Diagnostic products assist HCPs to Find and Follow diseases, with a focus in cardiology. Our Strategic Partnerships include biomarkers and digital solutions in support of our partners’ therapeutic development, out-licensing agreements for non-core assets and optimization of our assets geographically. We are headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Switzerland and Sweden. Our commercial products are used by cardiologists, internal medicine physicians, nuclear medicine physicians, oncologists, radiologists, sonographers, technologists, and urologists working in a variety of clinical settings. We believe that our diagnostic products provide information that enables HCPs to better detect and characterize, or rule out, disease, with the potential to achieve better patient outcomes, reduce patient risk, and limit overall costs. We produce and market our products throughout the United States (the “United States” or the “U.S.”), selling primarily to hospitals, independent diagnostic testing facilities, and radiopharmacies. We sell our products outside the U.S. through a combination of direct distribution in Canada and third-party distribution relationships in Europe, Canada, Australia, Asia-Pacific, Central America, and South America. ### Recent Developments We continue to execute on our strategy to evolve into a fully integrated radiopharmaceutical company, supported by our increasingly diversified portfolio and our targeted initiatives to expand our pipeline, commercial, development and manufacturing capabilities. Over the past year, we announced multiple strategic transactions, which furthered our goal to focus on new markets and expand and diversify our capabilities and development pipeline with complementary assets. ### Share Repurchase Program On July 31, 2025, our Board of Directors (the “Board”) authorized a program to repurchase up to $400.0 million of shares of our common stock through December 31, 2027 (the “2025 Program”). The 2025 Program replaces the program authorized by the Board in November 2024 to repurchase up to $250 million of our common stock during the twelve months following the authorization (the “2024 Program”), including the remaining unused amounts under the 2024 Program, and authorizes us to purchase shares of our common stock from time to time via open market purchases at prevailing market prices, in privately negotiated transactions, block trades, or pursuant to trades intending to comply with Rule 10b5-1 under the Exchange Act or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. The timing, manner, price and amount of any repurchase will be subject to the discretion of our Management. The 2025 Program does not obligate us to acquire any particular amount of its common stock, and we may suspend or discontinue the 2025 Program at any time. ### Acceptance of NDA for PSMA PET Imaging Agent On August 6, 2025, we announced that the FDA had accepted our New Drug Application (“NDA”) for a new formulation of our F-18 PSMA PET imaging agent, filed by our affiliate Aphelion LLC (“Aphelion”), and that the FDA set an action date goal of March 6, 2026 under the Prescription Drug User Fee Act (“PDUFA”). The new formulation was designed to optimize the manufacturing process and increase the batch size of our F-18 PSMA PET imaging agent by approximately 50%. If the NDA is approved, we plan to work closely with clinicians and PMF sites to ensure a smooth rollout of the new formulation, including providing clear guidance on ordering, handling, and clinical use to support continuity of care for patients, and we plan to apply for reimbursement from the Centers for Medicare and Medicaid Services (“CMS”) for the new formulation, including obtaining three years of TPT Status. ### Acquisition of Life Molecular Imaging On July 21, 2025, we acquired Life Molecular for an upfront payment of $350.0 million in cash and up to an additional $400.0 million in potential earn-out and milestone payments, pursuant to the terms of the Sale and Purchase Agreement with Life Medical Group Limited and Life Healthcare Group Holdings Limited. Life Molecular is based in Berlin, Germany and is dedicated to advancing novel PET radiopharmaceutical diagnostics. The acquisition includes Neuraceq, an approved Alzheimer's disease diagnostic. Previously, on July 3, 2024,we acquired from Life Molecular the global rights to RM2, its clinical stage, gastrin-releasing peptide receptor (“GRPR”)-targeting agent, including the associated novel, clinical-stage radiotherapeutic and radiodiagnostic pair, previously referred to as 177Lu-DOTA-RM2 and 68Ga-DOTA-RM2 (and which we now refer to as LNTH-2402 and LNTH-2401, respectively), for an upfront payment of $35.0 million plus a $1.0 million payment made prior to the acquisition (the “RM2 Asset Purchase”). In addition, in March 2025, the Company paid a $5.4 million milestone payment related to regulatory activities. On July 21, 2025, we acquired Life Molecular pursuant to a Sale and Purchase Agreement, dated as of January 12, 2025, with Life Medical Group Limited (the “Seller”) and Life Healthcare Group Holdings Limited (the “Sale and Purchase Agreement”). In connection with the completion of this acquisition, we entered into a Deed of Amendment and Restatement (the “Amendment”) to the Sale and Purchase Agreement, pursuant to which, among other things, the parties agreed to deliver the consideration for the RM2 Asset Purchase to the Seller, rather than to Life Molecular (which was the original party to the agreement pursuant to which the Company purchased the RM2 license). We may be required to pay the Seller additional milestone payments and royalties in connection with the RM2 Asset Purchase. GRPR is a member of the bombesin G protein-coupled receptor family, which has been found to be overexpressed in multiple cancers, including prostate, breast and lung. First-in-human dosimetry showed a favorable safety and dosimetry profile and confirmed preclinical data demonstrating dose-dependent efficacy of LNTH-2402. We intend to submit investigational new drug applications in support of a Phase 1b/2 clinical trial with the LNTH-2401/LNTH-2402 theranostic pair in prostate cancer patients in the fourth quarter of 2025. For more information on the acquisition of the global rights to RM2, see Note 19, “*Acquisitions”* in our condensed consolidated financial statements herein. ### Acquisition of Evergreen Theragnostics On April 1, 2025 (the “Closing Date”), we acquired all the issued and outstanding shares of Evergreen by means of a statutory merger of a subsidiary of the Company with and into Evergreen, with Evergreen surviving as the Company’s wholly-owned subsidiary (the “Evergreen Merger”), pursuant to the terms of the Agreement and Plan of Merger (the “Evergreen Merger Agreement”) with Evergreen and Shareholder Representative Services LLC. Evergreen is a clinical-stage radiopharmaceutical company engaged in contract development and manufacturing services as well as drug discovery and commercialization of proprietary products. As consideration for the Evergreen Merger, we remitted an upfront payment of $276.4 million in cash. We may make additional potential milestone payments of up to $727.5 million in cash, which may be adjusted pursuant to the Evergreen Merger Agreement, as described therein. For more information, see Note 19, “*Acquisitions”* in our condensed consolidated financial statements herein. ### Sale of SPECT business On May 1, 2025, we entered into a definitive agreement to sell our SPECT business to SHINE, a wholly-owned subsidiary of Illuminated Holdings, Inc. Under the terms of the agreement, SHINE will acquire the assets and liabilities associated with our SPECT business, including its diagnostic agents (TechneLite, NEUROLITE, Xenon Xe-133 Gas, and Cardiolite), the portion of the North Billerica, Massachusetts campus that manufactures our SPECT products and the SPECT-related Canadian operations. The transaction allows us to focus on growing our commercial portfolio of innovative PET radiodiagnostics and microbubbles, while advancing our pipeline of radiopharmaceuticals. The transaction is subject to customary closing conditions and is expected to be completed around the end of the calendar year. ### Acquisition of NAV-4694 On June 18, 2024, we acquired Meilleur Technologies Inc. (“Meilleur”), including its asset NAV-4694, an investigational late-stage F-18-labeled PET imaging agent that targets beta amyloids in Alzheimer’s disease. Under the terms of the agreement, we paid the stockholders of Meilleur (“Meilleur Stockholders”) an upfront payment of $32.9 million and paid an additional $10.0 million in August 2024 after the successful completion of a technology transfer. We could pay additional milestone payments upon achievement of specified U.S. regulatory and commercial milestones related to NAV-4694. We could also pay a double-digit royalty on research revenue and commercial sales. Research revenue is derived from partnerships with pharmaceutical companies and academic institutions that use NAV-4694 in clinical trials. NAV-4694 is currently in Phase 3 development and is also being used in academic and industry sponsored clinical trials. We expect to submit an NDA for NAV-4694 in 2026. In May 2025, we paid AstraZeneca AB (“AstraZeneca”), a $10.0 million one-time, non-refundable upfront payment to reduce the future royalty obligations owed to AstraZeneca, pursuant to a license agreement between AstraZeneca and Meilleur related to NAV-4694. For more information, see Note 19, “*Acquisitions”* in our condensed consolidated financial statements herein. ### Exclusive License for Radiopharm Theranostics Limited On June 15, 2024, we entered into an agreement with Radiopharm to acquire all of Radiopharm’s rights to two licensed preclinical assets for an upfront payment of $2.0 million (the “Radiopharm Asset Purchase”). We acquired global, exclusive rights to both a leucine-rich repeat-containing protein 15 (“LRRC15”)-targeted monoclonal antibody, which we refer to as LNTH-2403, and a Trophoblast cell surface antigen 2 targeted nanobody, which we refer to as LNTH-2404, each of which is a preclinical therapeutic candidate. LNTH-2403 is our pre-clinical therapeutic targeting LRRC15, which is strongly expressed in multiple malignancies, including head and neck, breast, lung, and pancreatic cancers. We are initially focusing on osteosarcoma, for which the FDA has granted both Orphan Drug and Rare Pediatric Disease designations. Osteosarcoma is a malignant bone tumor that primarily develops in children and teenagers. Osteosarcoma is the most common childhood bone cancer, though it is still rare, with around 1,000 new cases diagnosed annually in the U.S. In connection with this acquisition, we assumed the underlying license agreements related to the two preclinical assets, together with their respective milestone and royalty payment obligations. During the third quarter of 2024, we purchased 149,625,180 shares of Radiopharm common stock (“Radiopharm Shares”) at the fair market offering price of approximately $0.03 per share, for an aggregate purchase price of approximately $5.0 million. In January 2025, we purchased an additional 133,333,333 Radiopharm Shares at the fair market price of approximately $0.04, for an aggregate purchase price of approximately $5.0 million. At June 30, 2025, we held 282,958,513 Radiopharm Shares. For more information, see Note 19, “*Acquisitions”* and Note 4, “*Fair Value of Financial Instruments”* in our condensed consolidated financial statements herein. ### Strategic Agreements with Perspective Therapeutics, Inc. On January 8, 2024, we entered into multiple strategic agreements with Perspective, a radiopharmaceutical company that is pursuing advanced treatment applications for cancers throughout the body. Under the agreements, we obtained an option to exclusively license Perspective’s Pb212-VMT-α-NET, a clinical stage alpha therapy in development for the treatment of neuroendocrine tumors, and an option to co-develop certain early-stage therapeutic candidates targeting prostate cancer using Perspective’s innovative platform technology for an aggregate upfront payment of $28.0 million in cash. On January 22, 2024, we purchased 56,342,355 shares of Perspective’s common stock (“Perspective Shares”) at a purchase price of $0.37 per share in a private placement transaction for approximately $20.8 million in cash. We were also granted certain pro rata participation rights to maintain our ownership position in Perspective in the event that Perspective makes any public or non-public offering of any equity or voting securities, subject to certain exceptions. On March 1, 2024, we transferred the fixed assets and associated lease for the property at 110 Clyde Rd., Somerset, New Jersey (the “Somerset Facility”) to Perspective, and the parties entered into a transition services arrangement pursuant to which we provided Perspective certain services relating to final disposal of radioactive waste and certain other related services. On March 6, 2024, we purchased an additional 60,431,039 Perspective Shares at a price of $0.95 per share. The total consideration for this additional purchase was approximately $57.4 million, resulting in Lantheus Alpha holding approximately 19.90% of the outstanding Perspective Shares (or 17.35% on a fully diluted basis) as of March 6, 2024. On June 14, 2024, Perspective effected a 1-for-10 reverse stock split, after which we held 11,677,339 Perspective Shares. For more information, see Note 19, “*Acquisitions”* in our condensed consolidated financial statements herein. ### MK-6240 In 2023, we acquired Cerveau, which holds the rights under a license agreement to develop and commercialize MK-6240, an investigational late-stage F-18-labeled PET imaging agent that targets tau tangles in Alzheimer’s disease. Under the terms of the purchase agreement, the former stockholders of Cerveau are eligible to receive certain development and commercial milestone payments, in addition to the initial payments made in 2023. We will pay double-digit royalty payments for research revenue and commercial sales. Research revenue is derived from partnerships with pharmaceutical companies and academic institutions that use MK-6240 in clinical trials and includes milestone and dose-related payments. In September 2023, MK-6240 was granted Fast Track designation by the FDA. In 2024, we held a pre-NDA meeting with the FDA, and during the second quarter of 2025, we announced that MK-6240 successfully met its co-primary endpoints in two pivotal studies assessing its sensitivity and specificity. The data from these two studies will support an NDA submission to the FDA expected to be filed in the third quarter of 2025, but we can provide no assurance that we will meet that expected timeline, that our NDA will be accepted by the FDA, that MK-6240 will be approved by the FDA or, if approved, that we will be successful in commercialization. For more information, see Note 17, “*Commitments and Contingencies”* in our condensed consolidated financial statements included herein. ### Amendment of Credit Facility In December 2024, we amended our five-year revolving credit facility (as amended, the “2022 Revolving Facility”). The amendment, among other things, extended the maturity date from December 2, 2027 to December 19, 2029, increased the 2022 Revolving Facility from $350.0 million to $750.0 million and increased the additional amount that we may request to add to the increased revolving commitment by $350.0 million. The amendment also, among other things, (i) reduces the ranges of margins based on our Total Net Leverage Ratio (as defined in the 2022 Revolving Facility) used to calculate interest for the revolving loans and (ii) reduces the maximum unused commitment fee from 0.35% per annum to 0.30% per annum. ### Key Factors Affecting Our Results Our business and financial performance have been, and continue to be, impacted by the following: ### PYLARIFY Revenue PYLARIFY, an F-18-labeled PET imaging agent targeting prostate-specific membrane antigen (“PSMA”), was approved by the FDA in May 2021 and commercially launched in the U.S. in June 2021. PYLARIFY is indicated for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and in patients with suspected recurrence based on elevated prostate-specific antigen levels. PYLARIFY is available through a diverse, multi-partner network of PET manufacturing facilities (“PMFs”), including both commercial and academic partners. The successful growth of PYLARIFY is dependent on our ability to maintain PYLARIFY as the most utilized PSMA PET imaging agent in an increasingly competitive space. PYLARIFY’s competition includes three gallium-68-based PSMA imaging agents, an F-18-based PSMA imaging agent, and other non-PSMA-based imaging agents commonly referred to as conventional imaging. The potential for future generic entrants to the market due to the expiry of PYLARIFY’s new chemical entity exclusivity period in 2026 could also generate increased competition for PYLARIFY. We will continue to make investments necessary to drive PYLARIFY awareness and adoption. Growth and revenue contribution from PYLARIFY will also depend on our ability to clinically differentiate PYLARIFY from competitive products so that customers continue to choose PSMA PET with PYLARIFY for appropriate patients because of its clinical differentiation and despite the loss of TPT Status and changes to Medicare fee-for-service (“FFS”) hospital outpatient payment. Our Healthcare Procedure Coding System code, which enables streamlined billing, went into effect as of January 1, 2022. In addition, from January 1, 2022 to December 31, 2024, PYLARIFY had TPT Status from CMS in the hospital outpatient setting, enabling traditional Medicare FFS to provide separate payment for PYLARIFY in addition to the payment for the PET/computed tomography (“CT”) procedure in that setting. In November 2024, CMS released the final rule for its calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2025 OPPS Rule”), which recognized the value and need for broad access to diagnostic radiopharmaceuticals. The CMS 2025 OPPS Rule provided separate payment for those diagnostic radiopharmaceuticals with per day costs greater than $630 based on their mean unit cost (“MUC”) for the approximately 20% of patients with traditional Medicare FFS insurance coverage who are treated in the hospital outpatient setting. Effective January 1, 2025, CMS began maintaining separate payment for PYLARIFY based on MUC in the hospital outpatient setting, which is lower than payments based on the average selling price that were made during TPT Status. Although PYLARIFY continues to be paid separately, other competitive PSMA PET imaging agents continue to have TPT Status after December 31, 2024, and hospital use of those products, for the approximately 20% of traditional Medicare FFS patients in the hospital outpatient setting, generally will be paid separately based on ASP plus six percent rather than on MUC. In July 2025, CMS released the proposed rule for its calendar year 2026 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2026 Proposed OPPS Rule”). In the CMS 2026 Proposed OPPS Rule, CMS stated that it continues to believe Average Sales Price (“ASP”) data from manufacturers generally is insufficient for payment and that it is seeking comments on how CMS can ensure more consistent, validated, and universal reporting. We have repeatedly engaged CMS on methodology for reporting ASP, and we will continue to work with coalition partners and CMS to support using ASP to calculate payment for diagnostic radiopharmaceuticals in future years similar to the way Medicare Outpatient Prospective Payment System (“OPPS”) currently pays for other drugs, biologics, and therapeutic radiopharmaceuticals. Our plan to successfully grow PYLARIFY includes conveying its commercial and clinical value, negotiating and realizing the benefits from strategic contracts with customers in the U.S., expanding PYLARIFY’s use in appropriate new patient populations, and through strategic partnerships and collaborations, including outside of the U.S. Internationally, we previously licensed exclusive rights to Curium Pharma ("Curium") to develop and commercialize piflufolastat F-18 in Europe, where it is being commercialized in the European Union under the brand name PYLCLARI. We have entered into strategic collaborations with pharmaceutical companies for the use of PYLARIFY in connection with the development of PSMA-targeted therapeutics. Additional information on these collaborations are described further under Part I, Item 1. “*Business - Strategic Partnerships and Other Revenue – Oncology”* in our Form 10-K for the year ended December 31, 2024. ### DEFINITY Revenue We believe we will be able to increase use of DEFINITY through continued education of physicians and HCPs about the benefits of ultrasound enhancing agents in suboptimal echocardiograms. The U.S. market currently has three echocardiography ultrasound enhancing agents approved by the FDA; we estimate that DEFINITY will continue to hold at least an 80% share of the U.S. segment for ultrasound enhancing agents in echocardiography procedures. As we continue to grow our microbubble platform, our activities include: - *Expansion of Label –* In March 2024, we received FDA approval for our supplemental NDA for the use of DEFINITY in pediatric patients with suboptimal echocardiograms. The FDA decision was based on usage data from three pediatric clinical trials conducted with DEFINITY. - *Patents –* We continue to actively pursue additional patents in connection with DEFINITY, both in the U.S. and internationally. In the U.S. for DEFINITY, we have Orange Book-listed method-of-use patents, as well as additional manufacturing patents that are not Orange Book-listed. ### Expansion of Strategic Partnerships and Other Revenue We continue to seek ways to further increase the overall value of our portfolio of products and product candidates. We are evaluating a number of different opportunities to collaborate, in-license or acquire additional products, product candidates, businesses and technologies to drive our future growth. In particular, with respect to our Strategic Partnerships and Other Revenue category, we are focused on radiopharmaceutical diagnostic and therapeutic product opportunities in oncology, neurology, and other strategic areas that will complement our existing portfolio. Our Strategic Partnerships and Other Revenue category includes our Strategic Partnerships, Digital Solutions, Biomarker Solutions and contract development and manufacturing organization (“CDMO”) services and is focused on enabling precision medicine with biomarkers, digital solutions and CDMO services. - *Strategic Partnerships –* We seek to monetize our assets through our Strategic Partnerships business, which includes biomarkers and digital solutions in support of our partners’ therapeutic development, out-licensing agreements for non-core assets and optimization of our assets geographically. For example, we licensed the commercialization rights for piflufolastat F-18 in Europe to Curium, where it is now commercialized under the brand name PYLCLARI, and for flurpiridaz, which received FDA approval in 2024 under the brand name Flyrcado, to GE Healthcare Limited (“GE Healthcare”) for coronary artery disease diagnosis. - *Digital Solutions –* Our Digital Solutions are designed to enhance imaging value and the throughput, reproducibility and reliability of image analysis, as well as to inform treatment selection and response to therapy. We offer our Digital Solutions to HCPs for clinical use and to pharmaceutical companies for development purposes, and in some cases, we also obtain clinical imaging data that we may use to further develop artificial intelligence solutions. Our Digital Solutions include artificial intelligence medical device software, such as aPROMISE and Automated Bone Scan Index, both of which are FDA cleared and received a European Conformity Marking. - *Biomarker Solutions –* We use our Biomarker Solutions business to offer our Biomarker and Microbubble Platforms to pharmaceutical companies to support their R&D of therapeutic drugs and devices. The strategic goal of our Biomarker Solutions business is to gain early access to innovation, de-risk the development, generate data, embed our technologies in the clinical ecosystem and establish the clinical utility of product candidates and research tools in our pipeline. Our biomarkers are intended to support patient selection and the monitoring of disease progression. MK-6240 is a widely utilized tau PET tracer in Alzheimer’s disease studies with over 100 ongoing academic and industry sponsored clinical trials, many for late-stage therapeutic candidates. NAV-4694 is also being used in academic and industry sponsored clinical trials. - *CDMO –* Through the Evergreen Merger, we acquired a Good Manufacturing Practices (“GMP”) certified radiopharmaceutical manufacturing facility that provides end-to-end manufacturing services for alpha- and beta-emitting radiopharmaceuticals, from early clinical development through commercial supply. Our CDMO offerings include process and analytical method development, technology transfer, process validation, production of clinical and commercial batches, release and stability testing, and integrated quality oversight under fully electronic Quality Management and Laboratory Information Management Systems. In addition, we coordinate raw material sourcing, just-in-time logistics, and packaging to facilitate timely delivery of finished product globally. Our CDMO’s strategic location near major transportation hubs enables reliable distribution for short half-life products and supports customers across diagnostic and therapeutic indications. ### Inventory Supply & Third Party Suppliers We obtain a substantial portion of our imaging agents from third-party suppliers. Although we manufacture DEFINITY at our facility in North Billerica, Massachusetts, Jubilant HollisterStier (“JHS”) is currently a significant supplier of DEFINITY and our sole source manufacturer of NEUROLITE, CARDIOLITE and evacuation vials, the latter being an ancillary component for our TechneLite generators. Our manufacturing and supply agreement with JHS (the “JHS MSA”) runs through December 31, 2027 and can be further extended by mutual agreement of the parties. The JHS MSA requires us to purchase from JHS specified percentages of our 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 JHS MSA upon the occurrence of certain events, including the material breach or bankruptcy of the other party. Radiopharmaceuticals are decaying radioisotopes with half-lives ranging from a few hours to several days. Radiopharmaceutical finished goods, such as doses of PYLARIFY, cannot be kept in inventory because of their limited shelf lives and are subject to just-in-time manufacturing, processing and distribution, which takes place at multiple PMF manufacturing partner sites that produce and deliver doses for us across the U.S. Our TechneLite generators and Xenon-133 are manufactured at our facilities in North Billerica, Massachusetts. ### Research and Development Expenses To ensure we remain the leading radiopharmaceutical-focused company, we have historically made and will continue to make substantial investments in new product development and lifecycle management for existing products, including: - For PYLARIFY, we are conducting a clinical trial to determine whether PYLARIFY can detect the presence or absence of additional prostate cancer lesions in patients with favorable intermediate-risk prostate cancer, as well as how it may change the patient’s intended management. We also continue to support investigator sponsored research with the potential to expand the clinical utility of PYLARIFY. - For PNT2002 and PNT2003, we were granted a license to exclusive worldwide rights (excluding certain countries) for $260.0 million in upfront payments during the fourth quarter of 2022 and, with respect to PNT2003, will potentially make additional payments as described below. We also filed an Abbreviated New Drug Application (“ANDA”) for PNT2003 as described further in the section entitled “*Exclusive License for PNT2002 and PNT2003”* in Part I, Item 1. “*Business - Other Notable Transactions”* of our Form 10-K for the year ended December 31, 2024. - For LNTH-2501, we acquired the rights to the investigational asset through our acquisition of Evergreen. We intend to submit an NDA for LNTH-2501 in 2025. - For MK-6240, we acquired the right to the investigational asset for an upfront payment of $35.3 million in February 2023 and an additional $10.0 million in May 2023 upon the successful completion of a technology transfer and will potentially make additional milestone and royalty payments. In 2024, we held a pre-NDA meeting with the FDA, and during the second quarter of 2025, we announced that MK-6240 successfully met its co-primary endpoints in two pivotal studies assessing its sensitivity and specificity. The data from these two studies will support an NDA submission to the FDA expected to be filed in the third quarter of 2025. - For NAV-4694, we acquired the rights to the investigational asset for an upfront payment of $32.9 million in June 2024 and an additional $10.0 million in August 2024 upon the successful completion of a technology transfer and will potentially make additional milestone and royalty payments. We intend to submit an NDA for NAV-4694 in 2026. In May 2025, we paid AstraZeneca a $10.0 million one-time, non-refundable upfront payment to reduce the future royalty obligations owed to AstraZeneca, pursuant to a license agreement between AstraZeneca and Meilleur related to NAV-4694. - For LNTH-1363S, in collaboration with Ratio Therapeutics LLC (previously NoriaTherapeutics Inc.), we completed a Phase 1 study to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry in adult healthy volunteers. We initiated a Phase 1/2a study in patients in 2024. - For RM2, we acquired global rights for an upfront payment of $35.0 million plus a $1.0 million payment made prior to the acquisition, paid a $5.4 million milestone payment related to regulatory activities, and could potentially make additional milestone and royalty payments in the future. We plan to initiate a Phase 1/2a study in prostate cancer patients in 2025. - For LNTH-2403 and LNTH-2404, we acquired the rights to the preclinical assets and the underlying license agreements for $2.0 million and will potentially make additional milestone and royalty payments. See Note 19, “*Acquisitions”* in our condensed consolidated financial statements herein for additional information on potential milestone and royalty payments related to the product candidates listed above. Our investments in these additional clinical activities and lifecycle management opportunities will increase our operating expenses and impact our results of operations and cash flow, and we can give no assurances as to whether any of these clinical development candidates or lifecycle management opportunities will be successful. #### PNT2002 Under the terms of the PNT2002 License Agreement, we paid POINT Biopharma Global Inc. (“POINT”) an upfront cash payment of $250.0 million. The Phase 3 registrational clinical trial for PNT2002, known as the “SPLASH” study, reached 100% of prespecified overall survival events. The results of the readout were comparable to the previously reported 46% and 75% readouts and remain confounded by the overwhelming number of patients who crossed over within the study to receive PNT2002. While we continue to work closely with our partner, Eli Lilly and Company, to review the full dataset, we do not plan to pursue an NDA or further invest in this asset. #### PNT2003 Under the terms of the PNT2003 License Agreement, we paid POINT an upfront payment of $10.0 million, and could pay up to an additional $34.5 million in milestone payments upon the achievement of specified U.S. and ex-U.S. regulatory milestones. POINT is also eligible to receive up to $275.0 million in sales milestone payments upon the achievement of specified annual sales thresholds of PNT2003. In addition, POINT is eligible to receive royalty payments of 15% of net sales of PNT2003. Our investments in these additional clinical activities and lifecycle management opportunities will increase our operating expenses and impact our results of operations and cash flow, and we can give no assurances as to whether any of these clinical development candidates or lifecycle management opportunities will be successful. ### Results of Operations The following is a summary of our consolidated results of operations: *(in thousands, except percent data)* | | Three Months Ended June 30, 2025 | 2024 | Change $ | Change % | Six Months Ended June 30, 2025 | 2024 | Change $ | Change % | | --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | | Revenues | $378,045 | $394,091 | $(16,046) | (4.1%) | $750,809 | $764,066 | $(13,257) | (1.7%) | | Cost of goods sold | 137,034 | 138,317 | (1,283) | (0.9%) | 272,098 | 266,446 | 5,652 | 2.1% | | Gross profit | 241,011 | 255,774 | (14,763) | (5.8%) | 478,711 | 497,620 | (18,909) | (3.8%) | | Operating expenses | | | | | | | | | | Sales and marketing | 41,041 | 45,035 | (3,994) | (8.9%) | 83,544 | 90,581 | (7,037) | (7.8%) | | General and administrative | 66,515 | 47,409 | 19,106 | 40.3% | 123,331 | 95,304 | 28,027 | 29.4% | | Research and development | 45,489 | 60,601 | (15,112) | (24.9%) | 81,803 | 108,625 | (26,822) | (24.7%) | | Total operating expenses | 153,045 | 153,045 | — | 0.0% | 288,678 | 294,510 | (5,832) | (2.0%) | | Gain on sale of assets | — | — | — | N/A | — | 6,254 | (6,254) | (100.0%) | | Operating income | 87,966 | 102,729 | (14,763) | (14.4%) | 190,033 | 209,364 | (19,331) | (9.2%) | | Interest expense | 4,917 | 4,862 | 55 | 1.1% | 9,721 | 9,721 | — | 0.0% | | Investment in equity securities - unrealized (gain) loss | (14,573) | 22,537 | (37,110) | (164.7%) | 289 | (38,167) | 38,456 | (100.8%) | | Other income | (6,895) | (9,044) | 2,149 | (23.8%) | (21,023) | (17,832) | (3,191) | 17.9% | | Income before income taxes | 104,517 | 84,374 | 20,143 | 23.9% | 201,046 | 255,642 | (54,596) | (21.4%) | | Income tax expense | 25,762 | 22,301 | 3,461 | 15.5% | 49,346 | 62,503 | (13,157) | (21.1%) | | Net income | $78,755 | $62,073 | $16,682 | 26.9% | $151,700 | $193,139 | $(41,439) | (21.5%) | 33 ### Comparison of the Periods Ended June 30, 2025 and 2024 ### Revenues We classify our revenues into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. Radiopharmaceutical Oncology includes PYLARIFY and historically included AZEDRA. In the first quarter of 2024, we discontinued the production of AZEDRA. Precision Diagnostics includes DEFINITY, TechneLite, and other diagnostic imaging products. Strategic Partnerships and Other Revenue primarily includes revenue derived from partnerships with pharmaceutical companies and academic institutions that use our investigational products, such as MK-6240 and NAV-4694 in clinical trials as research tools. This category of revenues also includes royalties and other milestone payments received from our strategic partners that have commercialized products pursuant to license arrangements with us as well as CDMO revenue generated by Evergreen, which we acquired on April 1, 2025. Revenues are summarized by product category on a net basis as follows: *(in thousands)* | | Three Months Ended June 30, 2025 | 2024 | Change $ | Change % | Six Months Ended June 30, 2025 | 2024 | Change $ | Change % | | --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: | | PYLARIFY | $250,642 | $273,255 | $(22,613) | (8.3)% | $508,296 | $532,125 | $(23,829) | (4.5)% | | Other radiopharmaceutical oncology | — | — | — | —% | — | 384 | (384) | (100.0)% | | Total radiopharmaceutical oncology | 250,642 | 273,255 | (22,613) | (8.3)% | 508,296 | 532,509 | (24,213) | (4.5)% | | DEFINITY | 83,939 | 78,100 | 5,839 | 7.5% | 163,150 | 154,664 | 8,486 | 5.5% | | TechneLite | 24,982 | 28,186 | (3,204) | (11.4)% | 44,693 | 49,900 | (5,207) | (10.4)% | | Other precision diagnostics | 6,892 | 5,825 | 1,067 | 18.3% | 12,333 | 11,757 | 576 | 4.9% | | Total precision diagnostics | 115,813 | 112,111 | 3,702 | 3.3% | 220,176 | 216,321 | 3,855 | 1.8% | | Strategic partnerships and other revenue | 11,590 | 8,725 | 2,865 | 32.8% | 22,337 | 15,236 | 7,101 | 46.6% | | Total revenues | $378,045 | $394,091 | $(16,046) | (4.1)% | $750,809 | $764,066 | $(13,257) | (1.7)% | The decrease in revenues for the three and six months ended June 30, 2025, as compared to the same periods of 2024, were primarily driven by a decrease in net sales price of PYLARIFY and a decrease in sales volume of TechneLite. These decreases were partially offset by an increase in DEFINITY sales volumes and contract manufacturing service revenue generated by Evergreen. In addition, for the six months ended June 30, 2025, the decreases were offset by revenue generated from sales for investigational use of NAV-4694, and milestone achievement for the first commercial sale of Flyrcado by GE Healthcare. #### Rebates and Allowances Estimates for rebates and allowances represent our estimated obligations under contractual arrangements with third parties. Rebate accruals and allowances are recorded in the same period the related revenue is recognized, resulting in a reduction to revenue and the establishment of a liability which is included in accrued expenses and other liabilities in our condensed consolidated balance sheets. These rebates and allowances result from performance-based offers that are primarily based on attaining contractually specified sales volumes and growth, Medicaid rebate programs for our products, administrative fees of group purchasing organizations, and certain distributor related commissions. The calculation of the accrual for these rebates and allowances is based on an estimate of the third-party’s expected purchases and the resulting applicable contractual rebate to be earned over a contractual period. An analysis of the amount of, and change in, reserves for rebates and allowances is summarized as follows: *(in thousands)* | | Rebates and Allowances | | --- | ---: | | Balance at January 1, 2025 | $25,248 | | Provision related to current period revenues | 68,992 | | Payments or credits made during the period | (42,507) | | Balance at June 30, 2025 | $51,733 | ### Gross Profit The decrease in gross profit for the three and six months ended June 30, 2025, as compared to the prior year periods, is primarily due to the decrease in PYLARIFY net sales price, partially offset by an increase in PYLARIFY sales volume and an increase in DEFINITY sales volume. In addition, for the three months ended June 30, 2025, the decrease in gross profit was partially offset by a reduction in vendor costs. ### Sales and Marketing Sales and marketing expenses consist primarily of salaries and other related costs for personnel in field sales, marketing, and customer service functions. Other costs in sales and marketing expenses include the development of advertising and promotional material, professional services, market research, and sales meetings. Sales and marketing expenses decreased $4.0 million and $7.0 million for the three and six months ended June 30, 2025, as compared to the prior year periods. This was primarily the result of an overall reduction in employee-related costs, as well a decrease in third party vendor and other marketing spend. In addition, the decrease for the six months ended June 30, 2025 included a one-time investment in a brand campaign launch for PYLARIFY that took place during the three months ended March 31, 2024, as well as the cessation in 2025 of launch support related to PNT2002. ### General and Administrative General and administrative expenses consist of salaries and other related costs for personnel in executive, finance, legal, information technology, and human resource functions. Other costs included in general and administrative expenses are professional fees for information technology services, external legal fees, consulting and accounting services as well as bad debt expense, certain facility and insurance costs, including director and officer liability insurance. General and administrative expenses increased $19.1 million and $28.0 million for the three and six months ended June 30, 2025, respectively, as compared to prior year periods. This was primarily driven by the impact of the acquisition of Evergreen in April 2025, including nonrecurring post-combination expenses related to the settlement of unvested Evergreen stock awards, which resulted in higher stock-based compensation expense and professional fees. In addition, with the increase in headcount from the acquisition, we incurred higher employee-related costs in the three and six months ended June 30, 2025, as compared to the same prior year periods. ### Research and Development R&D expenses relate primarily to salaries and costs related to the development of product candidates to add to our portfolio and costs related to our medical affairs, medical information and regulatory functions. R&D expenses decreased $15.1 million for the three months ended June 30, 2025, as compared to the same prior year period. This was primarily driven by an upfront option payment of $36.0 million in cash to Life Molecular to sublicense LNTH-2401 and LNTH-2402, as well as $2.0 million to Radiopharm to sublicense LNTH-2403 and LNTH-2404, in the second quarter of 2024. These decreases were partially offset by a payment to AstraZeneca of $10.0 million in May 2025 to reduce future royalty obligations for NAV-4694, expenses resulting from the acquisition of Evergreen in April 2025 and increases in project costs related to assets acquired in 2024, including LNTH-2401, LNTH-2402, LNTH-2403 and NAV-4694. R&D expenses decreased $26.8 million for the six months ended June 30, 2025, as compared to the same period of 2024. This was primarily driven by the upfront payment of $36.0 million to Life Molecular to sublicense LNTH-2401 and LNTH-2402, an upfront option payment of $28.0 million to Perspective, as well as $2.0 million to Radiopharm to sublicense LNTH-2403 and LNTH-2404, in each case during the prior year period. These decreases were partially offset by a payment to AstraZeneca of $10.0 million to reduce future royalty obligations for NAV-4694, expenses related to the acquisition of Evergreen, increases in project costs related to assets acquired in 2024 including LNTH-2401, LNTH-2402, LNTH-2403, and NAV-4694, as well as an increase in employee-related costs resulting from an increase in headcount. ### Investment in Equity Securities - Unrealized (Gain) Loss Investment in equity securities - net unrealized (gain) loss increased $37.1 million for the three months ended June 30, 2025, compared to the same period of 2024. Investment in equity securities - net unrealized (gain) loss decreased $38.5 million for the six months ended June 30, 2025, compared to the same period of 2024. Each quarter our investments in equity securities of Radiopharm and Perspective are revalued to market price. For the three months ended June 30, 2025, we recorded an unrealized loss on the investment in Radiopharm of $0.8 million and recorded an unrealized gain on the investment in Perspective of $15.3 million. For the six months ended June 30, 2025, we recorded an unrealized loss on the investment in Radiopharm of $3.3 million and recorded an unrealized gain on the investment in Perspective of $2.9 million. This is compared to unrealized gain on the investment in Perspective of $22.5 million for the three months ended June 30, 2024 and an unrealized loss on the investment in Perspective Shares of $38.2 million for the six months ended June 30, 2024. ### Other Income Other income decreased $2.1 million for the three months ended June 30, 2025 compared to the same period of 2024, primarily due to a decrease in interest income on lower average cash balances after the acquisition of Evergreen in April 2025. Other income increased $3.2 million for the six months ended June 30, 2025, compared to the same period of 2024, primarily due to a $4.7 million adjustment recorded to reduce the previous estimate of remediation costs related to the potential decommissioning of our facilities of their radioactive-related operations. See Note 10, “*Asset Retirement Obligations,”* for more information on our asset retirement obligation. This was partially offset by a decrease in interest income on lower average cash balances mentioned above. ### Income Tax Expense Our effective tax rate for each reporting period is presented as follows: | | Three Months Ended June 30, 2025 | 2024 | Six Months Ended June 30, 2025 | 2024 | | --- | ---: | ---: | ---: | ---: | | Effective tax rate | 24.6% | 26.4% | 24.5% | 24.4% | Our effective tax rate for the three months ended June 30, 2025 differs from the U.S. statutory rate of 21% primarily due to state income taxes and non-deductible stock compensation, partially offset by tax credits and the change in valuation allowance related to the fluctuation in value of our investment in equity securities balance. Our effective tax rate for six months ended June 30, 2025 differs from the U.S. statutory rate of 21% primarily due to state income taxes, partially offset by tax credits and the income tax benefits associated with stock compensation deductions. The decrease in the effective income tax rate for the three months ended June 30, 2025 is primarily due to the change in the valuation allowance related to the fluctuation in value of our investment in equity securities balance, partially offset by the increase in non-deductible stock compensation. There was no material change in the effective tax rate for the six months ended June 30, 2025, when compared to the same period of 2024. ### Liquidity and Capital Resources ### Cash Flows The following table provides information regarding our cash flows: *(in thousands)* | | Six Months Ended June 30, 2025 | 2024 | | --- | ---: | ---: | | Net cash provided by operating activities | $194,669 | $211,958 | | Net cash used in investing activities | $(296,190) | $(151,615) | | Net cash used in financing activities | $(116,632) | $(16,746) | #### Net Cash Provided by Operating Activities Net cash provided by operating activities of $194.7 million in the six months ended June 30, 2025 was primarily comprised of net income adjusted for the net effect of non-cash items such as unrealized loss (gain) on investment in equity securities, charges incurred in connection with the RM2 license, adjustments to the fair value of asset retirement obligation, depreciation, amortization and accretion expense, and stock-based compensation expense. The primary working capital sources of cash include an increase in accounts payable and accrued expenses which was attributable to the timing of payments to large vendors. The primary working capital uses of cash include an increase in trade receivables associated primarily with the timing of billings and collections and an increase in inventory related to the timing of batch processes. In addition, the Company recognized a nonrecurring post-combination expense attributed to the acceleration of historical Evergreen stock awards of $7.5 million. Net cash provided by operating activities of $212.0 million in the six months ended June 30, 2024 was primarily comprised of net income adjusted for the net effect of non-cash items such as unrealized gain on equity investment, charges incurred in connection with the Perspective IPR&D exclusive license option, charges related to Radiopharma’s licensed assets, charges related to Life Molecular’s RM2 license, depreciation, amortization and accretion expense and stock-based compensation expense. The primary working capital sources of cash were the timing of payments to large vendors. The primary working capital uses of cash were an increase in trade receivables associated primarily with the increase in PYLARIFY revenues, and an increase in inventory related to the timing of batch processes. #### Net Cash Used in Investing Activities Net cash used in investing activities during the six months ended June 30, 2025 was driven by $269.1 million paid to the former holders of Evergreen Shares for the acquisition of Evergreen, $5.0 million used to purchase equity securities, a $5.4 million milestone payment made related to RM2 and $16.7 million of capital expenditures. Net cash used in investing activities during the six months ended June 30, 2024 was driven by an upfront option payment of $28.0 million to Perspective, $1.0 million upfront payment to Life Molecular, $32.9 million upfront payment to the Meilleur Stockholders, $78.3 million for the purchase of equity securities and $19.4 million of capital expenditures, partially offset by net cash proceeds of $8.0 million from the sale of the Somerset facility sublease and associated assets. #### Net Cash Used in Financing Activities Net cash used in financing activities during the six months ended June 30, 2025 is primarily attributable to the repurchase of our common stock for approximately $100.0 million, the payments for minimum statutory tax withholding related to net share settlement of equity awards of $24.5 million, offset by proceeds of $8.3 million from stock option exercises and issuance of common stock. Net cash used in financing activities during the six months ended June 30, 2024 is primarily attributable to the payments for minimum statutory tax withholding related to net share settlement of equity awards of $20.4 million, offset by proceeds of $4.3 million from stock option exercises and issuance of common stock. ### External Sources of Liquidity In December 2024, we entered into an amendment to the 2022 Revolving Facility that, among other things, extended the maturity date from December 2, 2027 to December 19, 2029, increased the 2022 Revolving Facility from $350.0 million to $750.0 million and increased the additional amount that Lantheus Medical may request to add to the increased revolving commitment by $350.0 million. The amendment also, among other things, (i) reduces the ranges of margins based on our Total Net Leverage Ratio (as defined in the 2022 Revolving Facility) used to calculate interest for the revolving loans and (ii) reduces the maximum unused commitment fee from 0.35% per annum to 0.30% per annum. The full terms of the 2022 Revolving Facility are set forth in the Credit Agreement, dated as of December 2, 2022, by and among us, the lenders from time to time party thereto and Citizens Bank, N.A., as administrative agent and collateral agent, as amended. We have the right to request an increase to the 2022 Revolving Facility or request the establishment of one or more new incremental term loan facilities, in an aggregate principal amount of up to the greater of $685.0 million (so that the total amount available is $1.44 billion) or 100% of consolidated earnings before interest, taxes, depreciation and amortization for the four consecutive fiscal quarters most recently ended, plus additional amounts, in certain circumstances. Under the terms of the 2022 Revolving Facility, the lenders thereunder agreed to extend credit to us from time to time until December 19, 2029 consisting of revolving loans in an aggregate principal amount not to exceed $750.0 million at any time. The 2022 Revolving Facility includes a $40.0 million sub-facility for the issuance of letters of credit (the “Letters of Credit”). The 2022 Revolving Facility includes a $20.0 million sub-facility for swingline loans (the “Swingline Loans”). The Letters of Credit, Swingline Loans and the borrowings under the 2022 Revolving Facility are expected to be used for working capital and other general corporate purposes. Please refer to Note 12. “*Long-Term Debt, Net, and Other Borrowings”* to our condensed consolidated financial statements for further details on the 2022 Revolving Facility. As of June 30, 2025, we were in compliance with all financial and other covenants under the 2022 Credit Agreement. On December 8, 2022, we issued $575.0 million in aggregate principal amount of 2.625% Convertible Senior Notes due 2027 (the “Notes”), which includes $75.0 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, Lantheus Medical, as Guarantor, and U.S. Bank Trust Company, National Association, as Trustee. The net proceeds from the issuance of the Notes were approximately $557.8 million, after deducting the initial purchasers’ discounts and offering expenses payable by us. In November 2024, the Board authorized a program to repurchase up to $250 million of our common stock during the twelve months following the authorization (the “2024 Program”). During the three months ended June 30, 2025, we repurchased 1.3 million shares of our common stock for an aggregate purchase price of approximately $100.0 million. As of June 30, 2025, we have purchased approximately 2.4 million shares of our common stock under the 2024 Program for approximately $200.0 million. On July 31, 2025, the Board authorized the 2025 Program, which replaces the 2024 Program, including the remaining unused portion of the 2024 Program. Pursuant to the 2025 Program, we may repurchase up to $400.0 million in shares of our common stock through December 31, 2027, from time to time via open market purchases at prevailing market prices, in privately negotiated transactions, block trades, or pursuant to trades intending to comply with Rule 10b5-1 under the Exchange Act or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. The actual timing, number and dollar amount of repurchase transactions will be determined by our management, in its discretion and will depend on a number of factors, including but not limited to, the market price of our common stock. Our ability to fund our future capital needs will be affected by our ability to continue to generate cash from operations and may be affected by our ability to access the capital markets, money markets or other sources of funding, as well as the capacity and terms of our financing arrangements. We may from time to time repurchase or otherwise retire our debt and take other steps to reduce our debt or otherwise improve our balance sheet. These actions may include prepayments of our term loans or other retirements or refinancing of outstanding debt, privately negotiated transactions or otherwise. The amount of debt that may be retired, if any, could be material and would be decided at the sole discretion of our Board and will depend on market conditions, our cash position, and other considerations. ### Funding Requirements Our future capital requirements will depend on many factors, including: - The level of product sales and the pricing environment of our currently marketed products, particularly PYLARIFY and DEFINITY, as well as any additional products that we may market in the future; - Revenue mix shifts and associated volume and selling price changes that could result from additional competition or changes in customers’ product demand; - The continued costs of the ongoing commercialization of our products; - The costs to successfully integrate acquisitions, including of Life Molecular and Evergreen, including the potential for unforeseen expenses related to integration activities and liabilities within those businesses, costs 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; - Our investment in the further clinical development and commercialization of products and development candidates, as well as whether we exercise our option and co-development rights under the Perspective agreements; - The costs of acquiring or in-licensing, developing, obtaining regulatory approval for, and commercializing, new products, businesses or technologies, including any potential related milestone or royalty payments, together with the costs of pursuing opportunities that are not eventually consummated; - The costs of investing in our facilities, equipment and technology infrastructure; - The costs and timing of establishing or amending manufacturing and supply arrangements for commercial supplies of our products and raw materials and components; - Our ability to have products manufactured and released from manufacturing sites in a timely manner in the future, or to manufacture products at our in-house manufacturing facilities in amounts sufficient to meet our supply needs; - The costs of further commercialization of our existing products, particularly in international markets, including product marketing, sales and distribution and whether we obtain local partners to help share such commercialization costs; - The legal costs relating to maintaining, expanding and enforcing our intellectual property portfolio, pursuing insurance or other claims and defending against product liability, regulatory compliance, intellectual property or other claims, including the patent infringement claim related to the filing of our ANDA for PNT2003 and our patent infringement lawsuit against a healthcare-related imaging software developer; - The cost of interest on any additional borrowings which we may incur under our financing arrangements; and - The impact of sustained inflation on our costs of goods sold and operating expenses. Disruption in our financial performance could occur if we experience significant adverse changes in product or customer mix, significant changes in our competitive or regulatory environment, broad economic downturns, sustained inflation, adverse industry or company conditions or catastrophic external events, including pandemics, natural disasters and political or military conflict. If we experience one or more of these events in the future, we may be required to implement expense reductions, such as a delay or elimination of discretionary spending in all functional areas, as well as scaling back select operating and strategic initiatives. If our capital resources become insufficient to meet our future capital requirements, we would need to finance our cash needs through public or private equity offerings, debt financings, assets securitizations, sale-leasebacks or other financing or strategic alternatives, to the extent such transactions are permissible under the covenants of our 2022 Credit Agreement. Additional equity or debt financing, or other transactions, may not be available on acceptable terms, if at all. If any of these transactions require an amendment or waiver under the covenants in our 2022 Credit Agreement, which could result in additional expenses associated with obtaining the amendment or waiver, we will seek to obtain such an amendment or waiver to remain in compliance with those covenants. However, we cannot provide assurance that such an amendment or waiver would be granted, or that additional capital will be available on acceptable terms, if at all. At June 30, 2025, our only current committed external source of funds is our borrowing availability under our 2022 Revolving Facility. We had $695.6 million of cash and cash equivalents as of June 30, 2025. Our 2022 Revolving Facility contains a number of affirmative, negative, reporting and financial covenants, in each case subject to certain exceptions and materiality thresholds. Incremental borrowings under the 2022 Revolving Facility may affect our ability to comply with the covenants including the financial covenants restricting consolidated net leverage and interest coverage. Accordingly, we may be limited in utilizing the full amount of our 2022 Revolving Facility as a source of liquidity. Based on our current operating plans, we believe our balance of cash and cash equivalents, along with cash generated by ongoing operations and continued access to our 2022 Revolving Facility, will be sufficient to satisfy our cash requirements over the next twelve months and beyond. ### Critical Accounting Policies and Estimates The discussion and analysis of our financial condition and results of operations are based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect our reported assets and liabilities, revenues and expenses, and other financial information. Actual results may differ materially from these estimates under different assumptions and conditions. In addition, our reported financial condition and results of operations could vary due to a change in the application of a particular accounting standard. There have been no significant changes to our critical accounting policies or in the underlying accounting assumptions and estimates used in such policies in the six months ended June 30, 2025. For further information, refer to our summary of significant accounting policies and estimates in our Form 10-K for the year ended December 31, 2024. ### Off-Balance Sheet Arrangements We are required to provide the Massachusetts Department of Public Health financial assurance demonstrating our ability to fund any decommissioning of our North Billerica, Massachusetts production facility in the event of any closure. We have provided this financial assurance in the form of a $30.3 million surety bond. We have not engaged in any other off-balance sheet arrangements, including structured finance, special purpose entities or variable interest entities. ## Market risk As filed, 836 characters. For quantitative and qualitative disclosures about market risk, see Part II, Item 7A. “*Quantitative and Qualitative Disclosures About Market Risk,”* of our Form 10-K for the year ended December 31, 2024. Our exposures to market risk have not changed materially since December 31, 2024. ### Equity Investment Risk As of June 30, 2025, our recorded carrying value of investments in equity securities was $44.2 million, comprised of our equity investments in Perspective and Radiopharm, and is recorded at fair value, subject to market price volatility. We record our equity investments in public companies at fair value and adjust our equity investments in public companies for observable price changes or impairments. Valuations of public companies are variable and subject to change in share price at the applicable measurement period. ## Controls and procedures As filed, 928 characters. ### 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. ### Changes in Internal Controls Over Financial Reporting There were no changes in our internal control over financial reporting during the three months ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. ## Risk factors As filed, 30,855 characters. There have been no material changes to the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024, except as set forth below: ### Risks Related to Our Portfolio of Commercial Products ***Our ability to grow PYLARIFY as a commercial product is dependent on (A) the ability of positron emission tomography (“PET”) manufacturing facilities (“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 maintain adequate coding, coverage and payment for PYLARIFY, (C) our ability to promote PYLARIFY to customers and to maintain PYLARIFY as the most utilized prostate-specific membrane antigen (“PSMA”) PET imaging agent, which has been impacted by the expiration of transitional pass-through payment status (“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 an increasing number of potentially competitive products.*** To manufacture PYLARIFY, we assembled and qualified a nationwide network of PMFs with radioisotope-producing cyclotrons that make F-18, which has a 110-minute half-life, so PYLARIFY is manufactured and distributed rapidly to end-users. Because each of the PMFs manufacturing these products is deemed by the U.S. Food and Drug Administration (“FDA”) to be a separate manufacturing site, each has to be separately approved by the FDA. Although PYLARIFY is broadly available across the U.S., we continue to seek qualification for additional PMFs in 2025 and can give no assurance that the FDA will continue to approve PMFs in accordance with our expansion plans to meet product demand or that PYLARIFY will be available at the specific time of day preferred by the end-users or that our expansion plans accurately predict demand growth. To the extent that PYLARIFY is not available at preferred times, end users have, in some instances, switched to available competitive products. If FDA approval of manufacturing sites is delayed or withdrawn or if FDA requirements relating to site approval change impacting our ability to meet demand for PYLARIFY or end users scheduling needs or if we invest to extend our PMF network and demand does not grow to meet the expanded capacity, our business, results of operations, financial condition and cash flows would be adversely affected. Obtaining adequate coding, coverage, and payment for PYLARIFY is critical, including not only coverage from Medicare, Medicaid and other government payors, as well as private payors, but also appropriate payment levels to adequately cover our customers’ costs of using PYLARIFY in PET/computed tomography (“CT”) imaging procedures. The Healthcare Procedure Coding System code for PYLARIFY, which enables streamlined billing, went into effect as of January 1, 2022. PYLARIFY also had TPT Status from January 1, 2022 until December 31, 2024, which enabled traditional Medicare to provide an incremental payment for PET/CT scans performed with PYLARIFY in the hospital outpatient setting. After expiry of TPT Status, diagnostic radiopharmaceuticals, such as, PYLARIFY, historically would not have been separately reimbursed in the hospital outpatient setting but rather would be bundled into the facility payment a hospital receives for a PET/CT imaging procedure, and the facility payment may not have adequately covered the total cost of the procedure with the diagnostic radiopharmaceutical for all hospitals. In November 2024, the Centers for Medicare and Medicaid Services (“CMS”) released the final rule for its calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2025 OPPS Rule”). The CMS 2025 OPPS Rule became effective on January 1, 2025, pursuant to which previously packaged diagnostic radiopharmaceuticals are now “unbundled” with payments being made separately for any diagnostic radiopharmaceutical with a per day cost greater than $630 based on their mean unit cost (“MUC”). For approximately 20% of traditional Medicare fee-for-service (“FFS”) patients in the hospital outpatient setting, these changes enable hospitals that use innovative diagnostic radiopharmaceuticals, including PYLARIFY, to continue to be paid separately by CMS following the expiry of TPT Status at a rate that reflects MUC. The calendar year 2025 payment rate for PYLARIFY is based on MUC and is less than the Average Sales Price (“ASP”)-based amount that was paid during TPT Status. Although PYLARIFY continues to be paid separately, other competitive PSMA PET imaging agents continue to have TPT Status after December 31, 2024 and hospital use of those products, for the approximately 20% of traditional Medicare FFS patients in the hospital outpatient setting, generally will be paid separately based on ASP plus six percent rather than on MUC. In July 2025, CMS released the proposed rule for its calendar year 2026 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2026 Proposed OPPS Rule”). In the CMS 2026 Proposed OPPS Rule, CMS stated that it continues to believe ASP data available from manufacturers generally is insufficient as a basis for determining payment and that it is seeking comments on how CMS can ensure more consistent, validated, and universal reporting. We have reported and continue to report ASP for PYLARIFY, have engaged with CMS on the methodology for reporting ASP, and we will continue to work with coalition partners and CMS to support using ASP to calculate payment for diagnostic radiopharmaceuticals in future years similar to the way Medicare Outpatient Prospective Payment System (“OPPS”) currently pays for other drugs, biologics, and therapeutic radiopharmaceuticals. However, we can give no assurances that we will be successful in those efforts or that the availability of TPT Status for other diagnostic radiopharmaceuticals will not continue to impact clinical decision making regarding which product to use for all patient populations, which could have an adverse effect on our business, results of operations, financial condition and cash flows. Growth of PYLARIFY is also dependent on our ability to promote PYLARIFY to customers, to clinically and commercially differentiate PYLARIFY from other products on the market, to enter into and realize the benefits of strategic contracts with customers and to maintain PYLARIFY as the most utilized PSMA PET imaging agent in an increasingly competitive environment in which other PSMA PET imaging agents have been approved, for which discounts related to those other agents have been offered to customers and for which TPT Status may be available. PYLARIFY currently competes with three commercially available Ga-68-based PSMA PET imaging agents, two from Telix Pharmaceuticals Limited and one from Novartis AG and an F-18 PSMA PET imaging agent from Blue Earth Diagnostics Ltd. (“Blue Earth”), as well as other non-PSMA PET imaging agents. The potential for future generic entrants to the market due to the expiry of PYLARIFY’s new chemical entity exclusivity period in 2026 could also generate increased competition for PYLARIFY. Growth and revenue contribution from PYLARIFY will also depend on our ability to clinically differentiate PYLARIFY from competitive products so that customers continue to choose PSMA PET with PYLARIFY for appropriate patients because of its clinical differentiation and despite the loss of TPT Status and a potential economic difference that could result for the approximately 20% of traditional Medicare FFS patients in the hospital outpatient setting based on the CMS 2025 OPPS Rule, including through flexible and dependable access to PYLARIFY nationally, a best-in-class customer experience and continued promotion and education regarding PYLARIFY’s clinical and commercial attributes. Our ability to negotiate and realize the benefits from strategic contracts is also key to our ability to maintain and expand market share. Despite these efforts, we have seen net price compression and lost market share to certain competitors that have later approved products with TPT Status at a time when PYLARIFY’s TPT Status has expired, and we may experience further net price compression or lose market share to future competitive products due to reimbursement status as well as due to the impact of any potential generic entrant to the market. Such loss of market share could have an adverse impact on our business, results of operations, financial condition and cash flows. Our success in growing PYLARIFY also depends, in part, on our successfully establishing the use of PYLARIFY for new patient populations, such as patients with favorable intermediate-risk prostate cancer, and potentially for updates to the label, including for patient selection for PSMA-targeted therapeutics. For example, we are conducting a clinical trial to determine whether PYLARIFY can detect the presence or absence of additional prostate cancer lesions in patients with favorable intermediate-risk prostate cancer, as well as how it may change the patient’s intended management, but cannot predict whether the outcome of this clinical trial will support such a use of PYLARIFY. Similarly, we believe the approval of PLUVICTO for the treatment of adult patients with PSMA-positive metastatic castration-resistant prostate cancer (“mCRPC”) created a new addressable market for the use of PSMA PET imaging in patient selection for PSMA-targeted therapy. We can give no assurances as to how current clinical practice may evolve. To the extent we are unsuccessful in establishing the use of PYLARIFY in new patient populations, such lack of success could have an adverse impact on our business, results of operations, financial condition and cash flows. ### Potential generic competitors may seek to enter the market as a result of regulatory exclusivity expiration of PYLARIFY PYLARIFY currently has six Orange Book-listed patents, the last of which expires in 2037. PYLARIFY also holds a five-year new chemical entity (“NCE”) regulatory exclusivity, which expires on May 26, 2026. As described further under Part I, Item 1., “*Business - Regulatory Matters-Hatch Waxman Act,”* of our Annual Report on Form 10-K (“Form 10-K”) for the year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) on February 26, 2025, the FDA is allowed to accept an Abbreviated New Drug Application (“ANDA”) or 505(b)(2) application one year prior to the NCE expiration date under certain circumstances, specifically, from a generic challenger that includes a “Paragraph IV” Certification against each of the six patents we have listed in the Orange Book. If a Paragraph IV Certification is made, we could elect to pursue Hatch-Waxman litigation and trigger the 30-month stay described under Part I, Item 1., “*Business - Intellectual Property Matters – Patent-related Aspects of Regulatory Matters,”* of our Form 10-K for the year ended December 31, 2024 filed with the SEC on February 26, 2025, during which period the FDA would be prohibited from granting full approval to the challenger’s application. As of the date of filing of this Form 10-Q, we have not received any notice of a Paragraph IV Certification, but we can give no assurance that we will not receive notice of a Paragraph IV Certification in the future. If an ANDA or 505(b)(2) applicant were to file prior to the expiration of our NCE regulatory exclusivity, and we were to timely sue pursuant to the Hatch-Waxman Act, then the automatic stay of FDA approval could run until November 26, 2028, calculated as 30 months from the NCE expiration date (May 26, 2026), unless prior to such date the generic challenger successfully invalidates or proves non-infringement of all six Orange Book-listed patents or the lawsuit is otherwise settled. If litigation is ongoing in November 2028, then any generic launch would be at risk of the litigation determining that the generic challenger was infringing one or more of our patents Patent litigation is complex and can be protracted and expensive, so if we were to receive such a notice and to challenge the applicant, this could have a negative effect on our business, results of operations and financial condition. ***We may not, or may take longer to, realize the expected benefits and opportunities related to, investments we have made to develop our new formulation of our PSMA PET Imaging Agent.*** On August 6, 2025, we announced that the FDA had accepted our New Drug Application (“NDA”) for a new formulation of our F-18 PSMA PET imaging agent, filed by our affiliate Aphelion, and that the FDA set an action date goal of March 6, 2026 under the Prescription Drug User Fee Act (“PDUFA”). The new formulation was designed to optimize the manufacturing process and increase batch size of the F-18 PSMA PET imaging agent by approximately 50%. If the NDA is approved, we plan to work closely with clinicians and PMF sites to ensure a smooth rollout of the new formulation, including providing clear guidance on ordering, handling, and clinical use to support continuity of care for patients, and we plan to apply for CMS reimbursement for the new formulation, including obtaining three years of TPT Status; however, we can provide no assurance that the new formulation will be approved by the FDA, that we will meet our timeline for our planned rollout, or that we will obtain TPT Status. ### Risks Related to Reimbursement and Regulation ***Reforms to the U.S. healthcare system, including changes to policies, guidelines and practices of regulatory authorities, may adversely affect our business.*** A significant portion of our patient volume is derived from U.S. government healthcare programs, principally Medicare, which are highly regulated and subject to frequent and substantial changes. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “Healthcare Reform Act”) substantially changed the way healthcare is financed by both governmental and private insurers. The law contains a number of provisions that affect coverage and reimbursement of drug products and medical imaging procedures performed in the U.S. Subsequently, the Medicare Access and CHIP Reauthorization Act of 2015 significantly revised the methodology for updating the Medicare physician fee schedule. In 2017, Congress enacted legislation that effectively eliminated the Healthcare Reform Act's “individual mandate” beginning in 2019. On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (the “OBBBA”), which will reduce existing patient coverage under Medicaid. The expiration of certain subsidies for Marketplace coverage currently in place under the Healthcare Reform Act at the end of 2025 may also cause material coverage losses. The OBBBA further restricts Medicaid financing, which will decrease federal funds available to state Medicaid agencies and may result in reduced state Medicaid agency reimbursement rates. Congress continues to consider other healthcare reform legislation. There is no assurance that the Healthcare Reform Act, as currently enacted or as amended in the future, will not adversely affect our business and financial results, and we cannot predict how future federal or state legislative, judicial or administrative changes relating to healthcare reform will affect our business. In addition, other legislative changes have been proposed and adopted since the Healthcare Reform Act was enacted. The Budget Control Act of 2011 and subsequent Congressional actions includes provisions to reduce the federal deficit. These provisions have resulted in the imposition of 2% reductions in Medicare payments to providers, which went into effect on April 1, 2013 and will remain in effect through fiscal year 2030. The imposition of the 2% payment adjustment had been suspended through March 31, 2022 and went into effect as of April 1, 2022. The Congressional Budget Office estimates that, absent future action, the OBBBA will lead to $490 billion in Medicare cuts from 2027 to 2034. Any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs that may be implemented and/or any significant taxes or fees that may be imposed on us, as part of any broader deficit reduction effort or legislative replacement to the Budget Control Act, could have an adverse impact on our business, results of operations, financial condition and cash flows. Further, changes in payor mix and reimbursement by private third-party payors may also affect our business. Rates paid by some private third-party payors are based, in part, on established physician, clinic and hospital charges and are generally higher than Medicare payment rates. Reductions in the amount of reimbursement paid for diagnostic medical imaging procedures, including the elimination of any additional payment such as TPT Status, and changes in the mix of our patients between non-governmental payors and government sponsored healthcare programs and among different types of non-government payor sources, could have a material adverse effect on our business, results of operations, financial condition and cash flows. The full impact on our business of healthcare reforms and other new laws, or changes in existing laws, the interpretations of those laws, or changes to the way regulations and regulatory guidance has been implemented, amended and interpreted, is uncertain. Nor is it clear whether additional legislative or executive branch changes will be adopted or how those changes would affect our industry in general or our ability to successfully commercialize our products or develop or commercialize new products. For example, recent government actions, including reductions in staff and department reorganizations, including those at the FDA, could adversely affect the timing of anticipated regulatory actions or their outcome, and could change historical practices relating to the application or interpretation of regulations relevant to our operations in ways that could have an adverse effect on our business. It is unclear exactly how changes implemented by the U.S. Government will affect the U.S. healthcare system, and what impact this will have on our business. If the reforms made by the OBBBA are implemented and result in predicted coverage losses, these changes could reduce the overall number of diagnostic medical imaging procedures performed, reduce reimbursement rates, or both. ### Risks Related to Our Business Operations and Financial Results ***We may be adversely affected by prevailing economic conditions and financial, business and other factors beyond our control.*** Our ability to attract and retain employees and customers, to invest in and grow our business, to maintain our desired levels of costs of goods sold and operating expenses and to meet our financial obligations depends on our operating and financial performance, which, in turn, is subject to numerous factors, including the prevailing economic conditions, changes to financial, business and regulatory expectations, and other factors beyond our control, such as the rate of unemployment, the number of uninsured persons in the U.S., inflationary pressures, escalating prices, including those that may occur as a result of tariff policies. We cannot anticipate all the ways in which the current or future economic climate, financial market conditions and government actions could adversely impact our business. We are exposed to risks associated with reduced profitability and the potential financial instability of our customers, many of which may be adversely affected by conditions in the financial markets. For example, unemployment and underemployment, and the resultant loss of insurance, may decrease the demand for healthcare services and pharmaceuticals, including our products. If fewer patients are seeking medical care because they do not have insurance coverage, our customers may experience reductions in revenues, profitability and/or cash flow that could lead them to modify, delay or cancel orders for our products or seek lower cost alternatives to our products where available. If customers are not successful in generating sufficient revenue, are precluded from securing financing from the financial markets, or lose or cannot secure funding from the government, they may not be able to pay, or may delay payment of, accounts receivable that are owed to us. Research programs that could benefit from our investigational or commercial products may slow or be discontinued if funding cannot be secured or is withdrawn, which could delay when the results of such research becomes available and when or how often our products are purchased by third parties for use in their research programs. This, in turn, could adversely affect our financial condition and liquidity. To the extent prevailing economic conditions result in fewer procedures being performed or fewer research programs being completed, our business, results of operations, financial condition and cash flows could be adversely affected. In addition, we would expect our costs of goods sold and other operating expenses to change in the future in line with periodic inflationary changes. Because we intend to retain and continue to use our property and equipment, we believe that the incremental inflation related to the replacement costs of those items will not materially affect our operations. However, the rate of inflation affects our expenses, such as those for employee compensation, contract services, and transportation costs, which could increase our level of expenses and the rate at which we use our resources. Similarly, our operations and supply chain may subject us to tariffs and trade policies. For example, the U.S. government has increased, and has indicated a willingness to continue to increase, the use of tariffs by the United States. Such tariffs and any countermeasures taken by other countries could increase the cost of raw materials, components and equipment necessary for our operations, disrupt our global supply chain, create additional operational challenges or adversely impact our customers and business partners. While we generally believe that we will be able to offset the effect of inflationary and other changes by adjusting our product prices and implementing operating efficiencies, any material unfavorable changes in our costs of goods sold or other operating expenses, including from tariffs, could have a material adverse effect on our financial condition, results of operations and cash flows. ***An interruption in our ability to fulfill our obligations as a service provider or supplier to third parties, either through our contract development and manufacturing operations and/or in supplying our investigational products in support of research programs being conducted by third parties, may adversely affect our reputation and business.*** We have obligations to perform development and manufacturing services for third parties that have contracted with Evergreen for these services. These services are conducted out of a single location. Any disruption in our operations, any failure to timely and cost-effectively secure necessary personnel, components or materials, any failure to comply with the stringent regulations and requirements of the FDA and other regulatory authorities regarding the manufacture and development of radiopharmaceutical products, may cause us to fail to meet our contractual obligations and may adversely affect our business. We also have contractual commitments to supply our investigational products and certain of our commercial products to third parties as part of their own research programs. Our ability to supply these products may depend upon the ability of PMFs to manufacture the products to meet the requirements of each research program, including that the product be available at the specific time of day required by the third party’s research protocol, which may include locations both within and outside of the United States. We may have limited alternative PMF facilities in certain locations in the event one or more facility is unable to timely manufacture and supply the relevant products, and it may not be possible to timely manufacture the relevant products at required levels or at all, which may cause us to fail to meet our contractual obligations and may adversely affect our business. ***Our recent acquisitions, dispositions and other future strategic transactions may disrupt our ongoing business and create distractions for our management. Additionally, the risks related to these transactions, including the risk that we are unable to successfully integrate acquired businesses into our operations, the risk that we are unable to complete dispositions on the proposed terms or on the anticipated timeline, or at all, or are unable to realize the anticipated benefits that each transaction is predicted to bring, could adversely affect our business, financial condition or results of operations.*** As a part of our growth strategy, we have made and may continue to make selected acquisitions of complementary businesses, such as our recent acquisitions of Life Molecular Imaging Ltd. (“Life Molecular”) in July 2025 and Evergreen Theragnostics, Inc. (“Evergreen”) in April 2025. In addition, as part of our broader strategy, in May 2025, we announced that we had entered into a definitive agreement to sell our single-photon emission computerized tomography (“SPECT”) business to SHINE Technologies, LLC (“SHINE”). These transactions, in addition to advancing our existing pipeline and focusing our operations, create multiple competing interests that are complex and time-consuming, which may distract our management and disrupt our ongoing business. Our completed and any potential future acquisitions involve numerous risks and operational, financial, and managerial challenges, including the following, any of which could adversely affect our business, financial condition, or results of operations: - Coordinating or consolidating geographically separate organizations and integrating personnel with different business backgrounds and corporate cultures; - Integrating previously autonomous departments, including those in accounting and administrative functions; - Integrating financial information and management systems; - The pace of our acquisition activity and the related diversion of already limited resources and management and other personnel time; - Difficulties in integrating new operations, technologies, products, and personnel; - Inconsistencies in standards, controls, procedures, and policies; - Lack of synergies, if synergies are anticipated, or the inability to realize expected synergies and cost-savings; - Underperformance of any acquired technology, product candidate, or business relative to our expectations and the price we paid; - Managing the risks of entering markets or types of businesses in which we have limited or no direct experience; - Exposure to unforeseen liabilities; - The potential loss of key employees and strategic partners of acquired companies; and - Risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property. In addition, the successful integration of acquired businesses requires significant efforts and expense across all operational areas, including research and development, manufacturing, sales and marketing, finance, legal, and information technologies. There can be no assurance that any of our acquisitions will be successful or will be, or will become or remain, profitable. Our failure to successfully address the foregoing risks may prevent us from achieving the anticipated benefits from any acquisition in a reasonable time frame, or at all. Further, the pending disposition of our SPECT business to SHINE is subject to customary closing conditions. Such closing conditions may be time consuming, and we may not be able to complete the disposition on the proposed terms or in the anticipated timeline, or at all. Additionally, there may be unforeseen expenses related to this divestiture, or we may fail to realize the expected benefits of this transaction. ***We may be unable to successfully integrate Life Molecular’s Alzheimer’s disease radiodiagnostic commercial infrastructure and grow the appropriate use of Neuraceq to detect beta-amyloid plaques in patients evaluated for Alzheimer’s disease.*** We completed our acquisition of Life Molecular on July 21, 2025, which included the acquisition of Neuraceq, a globally approved F-18 PET imaging agent used to detect beta-amyloid plaques in patients evaluated for Alzheimer’s disease, as well as the addition of an Alzheimer’s disease radiodiagnostic commercial infrastructure, advanced research and development capabilities, and an established international footprint. If we are not able to continue to grow Neuraceq sales, which depend, in part, on the expansion of the Alzheimer’s disease therapeutic market, our ability to integrate Life Molecular’s commercial infrastructure, our ability to expand the PMF network where Neuraceq is currently produced in the U.S. and our ability to leverage both the PMF network in place for PYLARIFY in the U.S. and the network in place for Neuraceq to optimize the availability of both products across the U.S., we may not be able to continue to grow the revenue and cash flow of our business, which could have a negative effect on our business, results of operations and financial condition. ### Risks Related to Our Capital Structure ### Repurchases by us of our common stock may affect the value of our common stock. We have from time to time engaged in repurchase programs of our common stock. In July 2025, our Board of Directors (the “Board”) authorized a program to repurchase up to $400.0 million of shares of our common stock through December 31, 2027, via open market purchases, privately negotiated transactions, block trades or pursuant to trades intending to comply with Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. Such repurchases could increase, or prevent a decrease in, the market price of our common stock, although there can be no assurance that an increase, or prevention of a decrease, would occur, and stockholders could prefer that we allocate our capital in a different manner, which could negatively impact the market price of our common stock. Filed Aug 6, 2025. Source: SEC EDGAR, the filing index for accession 0000950170-25-103544. Last ingested by Listed: Oct 30, 2026, 13:54 ET. No prices; not investment advice.