Lantheus Holdings, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001193125-26-336795
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001193125-26-448622
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 188 previous paragraphs and 195 current paragraphs.
110 unchanged; 67 reworded; 16 added; 10 removed; 1 previous and 2 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (16)
Current report
LNTH-2401 Phase 2/3 Study
Current report
On September 28, 2026, we announced that the first patient has been dosed in SPARROW, a Phase 2/3 registrational trial evaluating LNTH-2401 (68Ga-DOTA-RM2). LNTH-2401 is an investigational Ga-68-labeled PET imaging agent that targets gastrin-releasing peptide receptor (“GRPR”), a biomarker that is highly expressed in many prostate cancers. SPARROW is an open-label, non-randomized, multicenter Phase 2/3 clinical trial evaluating investigational LNTH-2401 PET/computed tomography imaging in prostate cancer. The study consists of a Phase 2 dose optimization period followed by a Phase 3 diagnostic performance period.
Current report
Approval of PNT2003/BRAVNETSA
Current report
Approval of TAUKLARIFY
Current report
On August 14, 2026, we announced that the FDA approved TAUKLARIFY (florquinitau F-18 injection), also referred to as MK-6240, a radiodiagnostic agent indicated for PET of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify patients with tau neurofibrillary tangle pathology.
Current report
Following approval, we intend to continue to support the use of TAUKLARIFY in Alzheimer’s disease therapeutic programs through our Pharma Solutions business while assessing the appropriate path toward broader commercial availability. Our approach will remain aligned with the needs of our partners and informed by developments across the Alzheimer’s disease treatment landscape.
Current report
TAUKLARIFY’s approval is supported by two pivotal studies assessing its sensitivity and specificity. The data from these two studies analyzed TAUKLARIFY PET images from more than 500 subjects who participated in three clinical trials. The clinical trials included individuals with mild cognitive impairment, mild Alzheimer’s disease dementia and cognitively unimpaired individuals, enabling evaluation across a broad spectrum of cognitive function, including earlier stages of disease.
Current report
During the three months ended September 30, 2026, the Company received $8.6 million in cash from the sale of 2,938,328 Perspective Shares and realized a loss of $2.3 million, which was recorded within net loss (gain) on investment in equity securities in the Company’s condensed consolidated statements of operations for the three and nine months ended September 30, 2026.
Current report
in Part I, Item 1.“Business - Other Notable Transactions”of our Form 10-K for the year ended December 31, 2025. On September 22, 2026, we announced that the FDA granted final approval of the ANDA for PNT2003 under the brand name BRAVNETSA (lutetium Lu 177 dotatate). As a result of the approval of BRAVNETSA, we were obligated to make a $10.0 million regulatory milestone payment, to be paid during the fourth quarter of 2026. BRAVNETSA is indicated for the treatment of adult patients with SSTR+ GEP-NETs, including foregut, midgut, and hindgut neuroendocrine tumors.
Current report
Sales and marketing expenses decreased $0.8 million for the three months ended September 30, 2026, as compared to the same period of 2025. This was primarily due to a decrease in launch preparation costs for PYLARIFY TruVu and a decrease in employee-related costs.
Current report
General and administrative expenses decreased $11.5 million for the three months ended September 30, 2026, as compared to the same period of 2025. This was primarily driven by a $26.4 million decrease in non-recurring expenses related to the acquisition and integration of Evergreen and Lantheus Biosciences and the divestiture of our SPECT business recorded during the three months ended September 30, 2026, compared to the same period of 2025, a $2.8 million decrease in stock-based compensation expenses primarily due to the departure of executive-level employees at the end of 2025. Partially offsetting these decreases are increases that include costs related to the proposed Merger, primarily legal and other advisor costs of $18.6 million, for each of the three and nine months ended September 30, 2026, for which there are no comparable amounts recorded for the same period of 2025 and a $3.2 million increase resulting from the change in fair value of contingent consideration obligations from the acquisitions of Evergreen and Lantheus Biosciences.
Current report
R&D expenses increased $44.7 million for the three months ended September 30, 2026, as compared to the same prior year period. This was primarily driven by impairment charges of $21.0 million and $10.0 million recorded for LNTH-2620 (previously referred to as PI-2620) and LNTH-2515, respectively, during the three months ended September 30, 2026 as well as charges incurred in connection with regulatory milestone obligations due upon the FDA approval for TAUKLARIFY and BRAVNETSA of $14.3 million and $10.0 million, respectively. These increases were partially offset by the absence of $5.0 million of costs incurred in 2025 related to our NDA submission for TAUKLARIFY and reduced R&D support for a number of projects in 2026, as compared to 2025, including costs related to the acquisition and integration of Lantheus Biosciences, which decreased $1.4 million for the three months ended September 30, 2026, as compared to the same period of 2025.
Current report
Net Loss (Gain) on Investment in Equity Securities
Current report
Upon the sale of 2,938,328 Perspective Shares, we realized a loss of $2.3 million during the three and nine months ended September 30, 2026, which was recorded to net loss (gain) on investment in equity securities in our condensed consolidated statements of operations for the three and nine months ended September 30, 2026.
Current report
Other income, net, increased $4.2 million for the three months ended September 30, 2026, compared to the same prior year period, primarily due to an increase in interest income on higher average cash balances in 2026 compared to balances in 2025 after the acquisitions of Evergreen in April 2025 and Lantheus Biosciences in July 2025. In addition, we earned interest on the outstanding notes receivable with SHINE related to the sale of our SPECT business in January 2026. See Note 4,“Fair Value of Financial Instruments”to our condensed consolidated financial statements for more information on the notes receivable.
Current report
Income Tax (Benefit) Expense
Removed paragraphs (10)
Previous report
In February 2026, we announced an updated strategic focus on innovative PET radiodiagnostics, informed by our capabilities and customer relationships. Over the past year, we took purposeful, disciplined actions to optimize our portfolio and continue to strengthen our commercial and development capabilities, including strategic transactions that expanded our presence across oncology, neurology and cardiology while diversifying our pipeline. Some of our recent developments include the following:
Previous report
Tentative Approval of Abbreviated New Drug Application for PNT2003
Previous report
Acceptance of New Drug Application for MK-6240
Previous report
In October 2025, we announced that the FDA had accepted our NDA for MK-6240, our registrational F-18 tau-targeted PET imaging agent for the detection of tau neurofibrillary tangle pathology in patients with cognitive impairment being evaluated for Alzheimer’s disease, and has set a PDUFA target action date of August 13, 2026. In 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 supported our NDA submission to the FDA. MK-6240 previously received Fast Track designation from the FDA for its potential to address an unmet medical need in Alzheimer’s disease diagnostics.
Previous report
For LNTH-2515 (florbetaben F-18 injection), we acquired the rights to the asset through our acquisition of Lantheus Biosciences (formerly Life Molecular). LNTH-2515 is approved in the United States and certain other countries to estimate amyloid beta neuritic plaque density in adults with cognitive impairment and is commercialized under the brand name Neuraceq. LNTH-2515 is currently being developed for the diagnosis of amyloid light chain and transthyretin cardiac amyloidosis. FDA has granted Fast Track designation for this indication.
Previous report
R&D expenses decreased $7.3 million for the three months ended June 30, 2026, as compared to the same prior year period. This was primarily driven by a payment to AstraZeneca of $10.0 million in May 2025 to reduce future royalty obligations for NAV-4694 for which there was no comparable amount paid in 2026. Additional R&D expenses incurred in 2025 that did not have comparable amounts in 2026 include Evergreen integration costs of $3.3 million and $2.2 million in costs related to the FDA new drug application submission for PYLARIFY TruVu. These decreases were partially offset by the $9.1 million impact of the acquisition of Lantheus Biosciences in July 2025.
Previous report
Gain on Sale of Assets
Previous report
Investment in Equity Securities - Unrealized Loss (Gain)
Previous report
Other income, net increased $1.0 million for the three months ended June 30, 2026, compared to the same prior year period, primarily due to a gain on conversion of the Installment Note of $2.5 million recorded during the three months ended June 30, 2026 partially offset by a decrease in interest income on lower average cash balances after the acquisitions of Evergreen in April 2025 and Lantheus Biosciences in July 2025.
Previous report
Income Tax Expense
Reworded paragraphs (67)
Previous wording
Some of the statements contained in this Quarterly Report on Form 10-Q (“Form 10-Q”) are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements, including, in particular, statements about our plans, strategies, prospects and industry estimates, are subject to risks and uncertainties. These statements identify prospective information and can generally be identified by words such as “anticipated,” “believes,” “can,” “commitment,” “could,” “designed,” “ensuring,” “estimates,” “expects,” “generate,” “impact,” “increasingly,” “hopes,” “intends,” “launch,” “likely,” “long-term,” “maintain,” “may,” “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 related to such acquisitions, collaborations, development and commercialization plans. Examples of forward-looking statements include statements we make relating to our outlook and expectations including, without limitation, in connection with: (i) continued market expansion, penetration and reimbursement for our established commercial products, particularly PYLARIFY, DEFINITY and Neuraceq, in a competitive environment and our ability to clinically and commercially differentiate our products; (ii) our ability to complete the technology transfer across our positron emission tomography (“PET”) manufacturing facilities (“PMF”) network for PYLARIFY TruVu, the new formulation of our F-18 prostate-specific membrane antigen (“PSMA”) PET imaging agent approved by the U.S. Food and Drug Administration (“FDA”) on March 6, 2026, to obtain FDA approval for each PMF to manufacture PYLARIFY TruVu, to obtain adequate coverage and payment, including transitional pass-through payment status (“TPT Status”), for PYLARIFY TruVu, to have payers add Healthcare Common Procedure Coding System (“HCPCS”) coding to their systems on a timely basis and to have customers adopt PYLARIFY TruVu; (iii) the availability of raw materials, key components, equipment, manufacturing time slots, either used in the production of our products and product candidates, or by customers of our products and product candidates, including, but not limited to PET scanners for PYLARIFY, PYLARIFY TruVu, Neuraceq, MK-6240, LNTH-2501 and NAV-4694; (iv) our ability to have third parties manufacture our products and product candidates and our ability to manufacture DEFINITY in our in-house manufacturing facility, in amounts and at the times needed; (v) our ability to satisfy our obligations under our existing clinical development partnerships using Neuraceq, MK-6240 or NAV-4694 and other…
Excerpt shortened here; the source contains the full paragraph.
Current wording
Some of the statements contained in this Quarterly Report on Form 10-Q (“Form 10-Q”) are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements, including, in particular, statements about our plans, strategies, prospects and industry estimates, are subject to risks and uncertainties. These statements identify prospective information and can generally be identified by words such as “anticipated,” “believes,” “can,” “commitment,” “could,” “designed,” “ensuring,” “estimates,” “expects,” “generate,” “impact,” “increasingly,” “hopes,” “intends,” “launch,” “likely,” “long-term,” “maintain,” “may,” “pending,” “pipeline,” “plans,” “potential,” “predict,” “proposed,” “remain,” “seek,” “should,” “sustain,” “target,” “will,” “would” and similar expressions, or by express or implied discussions regarding the pending Merger (as defined below), potential or pending acquisitions, dispositions, collaborations, development and commercialization plans described in this Form 10-Q, or regarding potential future revenues and expenses related to such acquisitions, collaborations, development and commercialization plans. Examples of forward-looking statements include statements we make relating to our outlook and expectations including, without limitation, in connection with: (i) continued market expansion, penetration and reimbursement for our established commercial products, particularly PYLARIFY, DEFINITY and Neuraceq, in a competitive environment and our ability to clinically and commercially differentiate our products; (ii) our ability to complete the technology transfer across our positron emission tomography (“PET”) manufacturing facilities (“PMF”) network for PYLARIFY TruVu, the new formulation of our F-18 prostate-specific membrane antigen (“PSMA”) PET imaging agent approved by the U.S. Food and Drug Administration (“FDA”) on March 6, 2026, to obtain FDA approval for each PMF within our network to manufacture PYLARIFY TruVu, to maintain adequate coverage and payment for PYLARIFY TruVu, including the transitional pass-through payment status (“TPT Status”) granted by the Centers for Medicare & Medicaid Services, as announced on September 30, 2026, to have payers add Healthcare Common Procedure Coding System (“HCPCS”) code for PYLARIFY TruVu effective October 1, 2026 to their systems on a timely basis and to have customers adopt PYLARIFY TruVu; (iii) the availability of raw materials, key components, equipment, manufacturing time slots, either used in the production of our products and product candidates, or by customers of our products and product candidates, including, but not limited to PET scanners for PYLARIFY, PYLARIFY TruVu, Neuraceq, TAUKLARIFY, LNTH-2501 and NAV-4694; (iv) our ability to have third parties manufacture our products and product candidates and our ability to manufacture DE…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
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 for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 26, 2026 (our “Form 10-K”), and in Part II, Item 1A.“Risk Factors” in this Form 10-Q.
Current wording
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 (our “Form 10-K”) for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 26, 2026, and in Part II, Item 1A.“Risk Factors” in this Form 10-Q.
Previous wording
We are the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Prior to January 1, 2026, we classified our revenues into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. Following our sale of our SPECT business on January 1, 2026, we classify our revenues into four product categories: Oncology, Neurology, Cardiology, and Strategic Partnerships and Other Revenue, reflecting the evolution of our commercial portfolio and strategic focus. We have presented the prior year numbers for revenues to conform with our current year presentation, including the disaggregation of revenue related to the single-photon emission computerized tomography (“SPECT”) business which was divested to SHINE Technologies, LLC (“SHINE”), a wholly-owned subsidiary of Illuminated Holdings, Inc. (“Illuminated”), on January 1, 2026. Our Strategic Partnerships and Other Revenue category includes biomarkers and digital solutions supporting our partners’ therapeutic development, out-licensing agreements for non-core assets and geographically-focused commercialization strategies and contract development and manufacturing organization (“CDMO”) revenue generated by Evergreen. We are headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Switzerland, Sweden and the United Kingdom.
Current wording
We are the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Prior to January 1, 2026, we classified our revenues into three product categories: Radiopharmaceutical Oncology, Precision Diagnostics, and Strategic Partnerships and Other Revenue. Following our sale of our single-photon emission computerized tomography (“SPECT”) business on January 1, 2026, we classify our revenues into four product categories: Oncology, Neurology, Cardiology, and Strategic Partnerships and Other Revenue, reflecting the evolution of our commercial portfolio and strategic focus. We have presented the prior year numbers for revenues to conform with our current year presentation, including the disaggregation of revenue related to the SPECT business which was divested to SHINE Technologies, LLC (“SHINE”), a wholly-owned subsidiary of Illuminated Holdings, Inc. (“Illuminated”), on January 1, 2026. Our Strategic Partnerships and Other Revenue category includes biomarkers and digital solutions supporting our partners’ therapeutic development, out-licensing agreements for non-core assets and geographically-focused commercialization strategies and contract development and manufacturing organization (“CDMO”) revenue generated by Evergreen. We are headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Switzerland, Sweden and the United Kingdom.
Previous wording
On August 3, 2026, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Curium US Holdings LLC (the “Parent”) and Coco Merger Sub Inc. (the “Merger Sub”), pursuant to which the Parent will acquire all the outstanding shares of the our common stock for $102.50 per share in cash at closing. In addition, our shareholders will receive one contingent value right (“CVR”) representing the right to receive up to $12.00 per share in cash when and if payable, subject to the terms and conditions set forth in a contingent value rights agreement to be entered into among the Parent, us and a rights agent selected by the Parent and reasonably acceptable to us. The transaction is currently expected to close in the first half of 2027, subject to satisfaction of customary closing conditions, including receipt of our shareholders’ approval and regulatory approvals.
Current wording
On August 3, 2026, we entered into the Merger Agreement, pursuant to which, upon the terms and subject to the conditions set forth therein, the Parent will acquire all the outstanding shares of our common stock (other than certain excluded shares and shares for which appraisal rights have been properly exercised) by means of a statutory merger of its subsidiary with and into us (the “Merger”) for $102.50 per share in cash at closing. In addition, as part of the Merger, our stockholders will receive one contingent value right (“CVR”) per share representing the right to receive up to $12.00 per share in cash upon the achievement of certain specified commercial milestones, all subject to the terms and conditions set forth in a CVR agreement to be entered into among the Parent and a rights agent selected by the Parent and reasonably acceptable to us. The transaction is currently expected to close in the first half of 2027, subject to satisfaction of customary closing conditions, including receipt of certain regulatory approvals, including the expiration or termination of the waiting period under the HSR Act, which was extended on October 21, 2026 by the FTC. See Note 17,“Proposed Merger”for more information on the Merger Agreement.
Previous wording
On March 2, 2026, we announced that the FDA issued tentative approval of our Abbreviated New Drug Application (“ANDA”) for Lutetium Lu 177 Dotatate, also referred to as PNT2003, a radioequivalent version of LUTATHERA® (lutetium Lu 177 dotatate). LUTATHERA is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (“GEP-NETs”), including foregut, midgut, and hindgut neuroendocrine tumors. This tentative approval from the FDA indicates that the FDA has completed its review of the ANDA and determined that it meets the requirements for approval under the Federal Food, Drug and Cosmetics Act. The timing of our launch will consider the following factors: the timing of final FDA approval and disposition of legal proceedings related to the Hatch-Waxman process, as well as manufacturing and commercial readiness to ensure launch success.
Current wording
On September 22, 2026, we announced that the FDA granted final approval for BRAVNETSA (lutetium Lu 177 dotatate), previously known as PNT2003, a bioequivalent and therapeutically equivalent radiopharmaceutical to LUTATHERA (lutetium Lu 177 dotatate). BRAVNETSA was approved through the FDA’s Abbreviated New Drug Application (“ANDA”) pathway. Approval of this product expands radioligand treatment options for adult patients with somatostatin receptor-positive (“SSTR+”) gastroenteropancreatic neuroendocrine tumors (“GEP-NETs”), including foregut, midgut, and hindgut neuroendocrine tumors. As of the date of this report, we have not set a public launch date for BRAVNETSA but the launch will consider the disposition of legal proceedings related to the Hatch-Waxman process as well as manufacturing and commercial readiness to ensure launch success.
Previous wording
Complete Response Letter for LNTH-2501 New Drug Application (“NDA”)
Current wording
Complete Response Letter for LNTH-2501 New Drug Application
Previous wording
On March 17, 2026, we announced that the FDA has extended its review of the NDA for LNTH-2501, moving the Prescription Drug User Fee Act (“PDUFA”) target action date from March 29, 2026 to June 29, 2026. On June 26, 2026, we announced that the FDA issued a Complete Response Letter (“CRL”) regarding the NDA, stating that the agency could not approve the NDA by the June 29, 2026 extended PDUFA target action date due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions and approval of a resubmitted NDA is required before the LNTH-2501 NDA may be approved. LNTH-2501 is a diagnostic kit for the preparation of Gallium-68 (“Ga-68”) edotreotide injection, which has been studied for use with PET imaging for localization of somatostatin receptor-positive neuroendocrine tumors in adult and pediatric patients. The CRL did not identify any concerns regarding the data we submitted in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.
Current wording
On March 17, 2026, we announced that the FDA has extended its review of the NDA for LNTH-2501, moving the Prescription Drug User Fee Act (“PDUFA”) target action date from March 29, 2026 to June 29, 2026. On June 26, 2026, we announced that the FDA issued a CRL in response to the NDA, stating that the agency could not approve the NDA by the June 29, 2026 extended PDUFA target action date due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions and approval of a resubmitted NDA is required before the LNTH-2501 NDA may be approved. LNTH-2501 is a diagnostic kit for the preparation of Ga-68 edotreotide injection, which has been studied for use with PET imaging for localization of somatostatin receptor-positive neuroendocrine tumors in adult and pediatric patients. The CRL did not identify any concerns regarding the data we submitted in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.
Previous wording
In June 2026, we entered into a repurchase agreement (the “Repurchase Agreement”) with our distributor in China pursuant to which we repurchased from our distributor the license to DEFINITY in China along with the related materials, approvals, clinical trial research that had been accumulated since the original Distribution and Supply Agreement between the same parties (the “Supply Agreement”), which was executed in April 2012. The right to repurchase was in accordance with the Supply Agreement. The total consideration to be paid as part of the Repurchase Agreement is $30.0 million, which is expected to be paid in three tranches by the end of the first quarter of 2027 upon satisfaction of certain conditions.
Current wording
In June 2026, we entered into a repurchase agreement (the “Repurchase Agreement”) with our distributor in China pursuant to which we repurchased from our distributor the license to DEFINITY in China along with the related materials, approvals, clinical trial research that had been accumulated since the original Distribution and Supply Agreement between the same parties (the “Supply Agreement”), which was executed in April 2012. The right to repurchase was in accordance with the Supply Agreement. The total consideration to be paid as part of the Repurchase Agreement is $30.0 million. We paid $15.0 million of this consideration in July 2026 with the remaining two tranches expected to be paid by the end of 2026, upon satisfaction of certain conditions.
Previous wording
On March 6, 2026, we announced that the FDA approved PYLARIFY TruVu (piflufolastat F18), a new formulation of our F-18 PSMA PET imaging agent. PYLARIFY TruVu is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, or suspected recurrence based on elevated serum prostate-specific antigen (“PSA”). PYLARIFY TruVu is designed to enhance product stability at higher radioactive concentrations, supporting more efficient manufacturing and distribution, including the potential to increase batch sizes and serve broader geographic markets. PYLARIFY TruVu is expected to become commercially available beginning in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, with the intent to transition customers from PYLARIFY to PYLARIFY TruVu. We plan to work closely with clinicians and PET manufacturing facilities (“PMFs”) to support a smooth transition, including providing guidance on ordering, handling, and clinical use to support continuity of care. We are pursuing reimbursement for the new formulation from the Centers for Medicare and Medicaid Services (“CMS”), including seeking three years of TPT Status. In the second quarter of 2026, we submitted applications for both HCPCS coding and TPT Status, with a targeted October 1, 2026 effective date for both. On July 24, 2026, CMS granted a HCPCS code for PYLARIFY TruVu, with an effective date of October 1, 2026.
Current wording
On March 6, 2026, we announced that the FDA approved PYLARIFY TruVu (piflufolastat F-18), a new formulation of our F-18 PSMA PET imaging agent. PYLARIFY TruVu is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, or suspected recurrence based on elevated serum prostate-specific antigen (“PSA”). PYLARIFY TruVu is designed to enhance product stability at higher radioactive concentrations, supporting more efficient manufacturing and distribution, including the potential to increase batch sizes and serve broader geographic markets. PYLARIFY TruVu is expected to become commercially available beginning in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, with the intent to transition customers from PYLARIFY to PYLARIFY TruVu. We plan to work closely with clinicians and PMFs to support a smooth transition, including providing guidance on ordering, handling, and clinical use to support continuity of care. In the third quarter of 2026, the Centers for Medicare and Medicaid Services (“CMS”) granted a HCPCS code and TPT Status for PYLARIFY TruVu, each with an effective date of October 1, 2026.
Previous wording
On February 19, 2026, the Board approved a strategic program to simplify and streamline the Company’s operations so it can focus mainly on its radiodiagnostic business and pursue value-maximizing alternatives for its radiotherapeutic assets. As a result of the program along with other on-going operational initiatives, the Company has incurred $5.2 million and $13.0 million of charges during the three and six months ended June 30, 2026, respectively, and expects to continue to incur costs for the remainder of 2026.
Current wording
On February 19, 2026, our Board of Directors (the “Board”) approved a strategic program to simplify and streamline our operations so we can focus mainly on our radiodiagnostic business and pursue value-maximizing alternatives for our radiotherapeutic assets. As a result of the program along with other on-going operational initiatives, we incurred minimal charges during the three months ended September 30, 2026 and have incurred $12.5 million of charges during the nine months ended September 30, 2026. We expect to continue to incur costs for the remainder of 2026.
Previous wording
On January 1, 2026 (the “Disposition Date”), as a result of the sale of our SPECT business pursuant to the Equity and Asset Purchase Agreement, by and among Lantheus Medical, Lantheus MI Canada, Inc., Lantheus EU Limited, and Illuminated, SHINE SPECT, LLC, SHINE SPECT Medical Products, Ltd., and SHINE SPECT Limited (collectively referred to as “SHINE SPECT”), dated as of May 1, 2025 (the “SHINE SPECT Agreement”), we completed the sale of our SPECT business to SHINE SPECT (the “Disposition”) and we received consideration consisting of cash, notes receivable, a portion of which have been and a portion of which may be settled in equity of Illuminated or in cash depending on their specific terms, a right to receive additional cash on the earlier of January 1, 2030 or upon the occurrence of certain specified events, and the right to certain contingent consideration. The fair value of total consideration that we received on the Disposition Date was approximately $131.2 million, including $32.1 million in cash. Total net consideration reflects a $0.7 million increase resulting from the finalization of the post-close net working capital settlement during the three months ended June 30, 2026. See Note 4,“Fair Value of Financial Instruments”in our condensed consolidated financial statements for more information on the sale of our SPECT business.
Current wording
On January 1, 2026 (the “Disposition Date”), as a result of the sale of our SPECT business pursuant to the Equity and Asset Purchase Agreement, by and among Lantheus Medical, Lantheus MI Canada, Inc., Lantheus EU Limited, and Illuminated, SHINE SPECT, LLC, SHINE SPECT Medical Products, Ltd., and SHINE SPECT Limited (collectively referred to as “SHINE SPECT”), dated as of May 1, 2025 (the “SHINE SPECT Agreement”), we completed the sale of our SPECT business to SHINE SPECT (the “Disposition”) and we received consideration consisting of cash, notes receivable, a portion of which have been and a portion of which may be settled in equity of Illuminated or in cash depending on their specific terms, a right to receive additional cash on the earlier of January 1, 2030 or upon the occurrence of certain specified events, and the right to certain contingent consideration. The fair value of total net consideration that we received on the Disposition Date was approximately $131.2 million, including $32.1 million in cash. Total net consideration reflects a $0.7 million increase resulting from the finalization of the post-close net working capital settlement during the three months ended June 30, 2026, which was received on July 1, 2026. See Note 4,“Fair Value of Financial Instruments”in our condensed consolidated financial statements for more information on the sale of our SPECT business.
Previous wording
Brian Markison retired from Lantheus as Chief Executive Officer (“CEO”) and resigned from our Board of Directors (“Board”), both effective December 31, 2025. Mary Anne Heino, the Chair of our Board, was appointed as our Executive Chair and principal executive officer effective November 7, 2025. Ms. Heino became our CEO on January 1, 2026 and will continue to serve in that role until such time as the Board completes the comprehensive search process that it initiated to identify and appoint the Company’s next CEO. Following his retirement, Mr. Markison served as a strategic advisor to the Company during the first quarter of 2026.
Current wording
Brian Markison retired from Lantheus as Chief Executive Officer (“CEO”) and resigned from our Board, both effective December 31, 2025. Mary Anne Heino, the Chair of our Board, was appointed as our Executive Chair and principal executive officer effective November 7, 2025. Ms. Heino became our CEO on January 1, 2026 and intended to continue to serve in that role until such time as the Board completes the comprehensive search process that it initiated to identify and appoint the Company’s next CEO. In light of the transactions contemplated by the Merger Agreement, the Company paused its CEO search process. Following his retirement, Mr. Markison served as a strategic advisor to the Company during the first quarter of 2026.
Previous wording
In September 2025, we announced an exclusive licensing agreement for GE HealthCare Limited (“GE HealthCare”) to develop, manufacture, and commercialize Lantheus’ piflufolastat F-18 PET imaging agent (marketed in the United States as PYLARIFY) in Japan for prostate cancer diagnostics and companion diagnostic use. Under the terms of the agreement, GE HealthCare paid us an upfront license fee and will pay us development milestones and tiered royalties based on product sales in Japan.
Current wording
In September 2025, we announced an exclusive licensing agreement for GE HealthCare Limited (“GE HealthCare”) to develop, manufacture, and commercialize Lantheus’s piflufolastat F-18 PET imaging agent (marketed in the United States as PYLARIFY) in Japan for prostate cancer diagnostics and companion diagnostic use. Under the terms of the agreement, GE HealthCare paid us an upfront license fee and will pay us development milestones and tiered royalties based on product sales in Japan.
Previous wording
On July 31, 2025, our 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.
Current wording
On July 31, 2025, our 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 our common stock, and we may suspend or discontinue the 2025 Program at any time. We did not repurchase any shares under the 2025 Program in the three or nine months ended September 30, 2026. We repurchased 3.5 million shares for approximately $200.0 million under the 2025 Program, in 2025.
Previous wording
Previously, on July 3, 2024, we acquired from Lantheus Biosciences the global rights to RM2, its clinical stage, gastrin-releasing peptide receptor (“GRPR”)-targeting agent, including the associated novel, clinical-stage radiodiagnostic and radiotherapeutic pair, previously referred to as 68Ga-DOTA-RM2 and 177Lu-DOTA-RM2 (and which we now refer to as LNTH-2401 and LNTH-2402, respectively), for an upfront payment of $35.0 million plus a $1.0 million payment made prior to the acquisition (the “RM2 Asset Purchase”), pursuant to the Sublicense, Development and Collaboration Agreement, by and between us and Lantheus Biosciences, dated as of June 27, 2024 (the “RM2 Sublicense Agreement”). In addition, and pursuant to the RM2 Sublicense Agreement, we incurred €10.0 million in regulatory milestones in 2025, and agreed to pay up to an additional €127.5 million (reduced as discussed below) in regulatory and development milestone payments upon achievement of clinical trial thresholds and approvals in different regions up to €280.0 million in net sale milestones if products are commercialized and meet certain sales thresholds, and royalties on net sales of RM2.
Current wording
Previously, on July 3, 2024, we acquired from Lantheus Biosciences the global rights to RM2, its clinical stage, GRPR-targeting agent, including the associated novel, clinical-stage radiodiagnostic and radiotherapeutic pair, previously referred to as 68Ga-DOTA-RM2 and 177Lu-DOTA-RM2 (and which we now refer to as LNTH-2401 and LNTH-2402, respectively), for an upfront payment of $35.0 million plus a $1.0 million payment made prior to the acquisition (the “RM2 Asset Purchase”), pursuant to the Sublicense, Development and Collaboration Agreement, by and between us and Lantheus Biosciences, dated as of June 27, 2024 (the “RM2 Sublicense Agreement”). In addition, and pursuant to the RM2 Sublicense Agreement, we incurred €10.0 million in regulatory milestones in 2025, and agreed to pay up to an additional €127.5 million (reduced as discussed below) in regulatory and development milestone payments upon the achievement of clinical trial thresholds and approvals in different regions up to €280.0 million in net sales milestone payments if products are commercialized and meet certain sales thresholds, and royalties on net sales of RM2.
Previous wording
GRPR is a member of the bombesin G protein-coupled receptor family, which has been found to be overexpressed in multiple cancers. First-in-human dosimetry showed a favorable safety and dosimetry profile and confirmed preclinical data demonstrating dose-dependent efficacy of LNTH-2402. We plan to initiate our registrational program for LNTH-2401 in patients with prostate cancer this year.
Current wording
GRPR is a member of the bombesin G protein-coupled receptor family, which has been found to be overexpressed in multiple cancers. First-in-human dosimetry showed a favorable safety and dosimetry profile and confirmed preclinical data demonstrating dose-dependent efficacy of LNTH-2402. On September 28, 2026, we announced that the first patient had been dosed in SPARROW, a Phase 2/3 registrational trial evaluating LNTH-2401 in patients with prostate cancer.
Previous wording
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 strongly expressed in multiple malignancies, including head and neck, breast, lung, and pancreatic cancers. In connection with this acquisition, we assumed the underlying license agreements related to the two assets, together with their respective milestone and royalty payment obligations.
Current wording
On June 15, 2024, we entered into an agreement with Radiopharm to acquire all of Radiopharm’s rights to two licensed, then preclinical assets for an upfront payment of $2.0 million. One of those assets is a leucine-rich repeat-containing protein 15 (“LRRC15”)-targeted monoclonal antibody, which we refer to as LNTH-2403, a clinical therapeutic candidate. LNTH-2403 is strongly expressed in multiple malignancies, including head and neck, breast, lung, and pancreatic cancers. In connection with this acquisition, we assumed the underlying license agreements related to the two assets, together with their respective milestone and royalty payment obligations.
Previous wording
During 2024, we also purchased an aggregate of 11,677,339 shares of Perspective’s common stock, after giving effect to a 1-for-10 reverse stock split.
Current wording
During 2024, we also purchased an aggregate of 11,677,339 shares of Perspective’s common stock (“Perspective Shares”), after giving effect to a 1-for-10 reverse stock split.
Previous wording
Our strategy to support the continued growth of our PSMA PET franchise includes the approval and planned commercialization of a new formulation of our F-18 PSMA PET imaging agent, including obtaining TPT Status for this formulation. On March 6, 2026, the FDA approved this new formulation, PYLARIFY TruVu, which is designed to enhance product stability at higher radioactive concentrations and support more efficient manufacturing and broader distribution. PYLARIFY TruVu is expected to become commercially available beginning in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, with the intent to transition customers from PYLARIFY to PYLARIFY TruVu. In the second quarter of 2026, we submitted applications for both HCPCS coding and TPT Status, with a targeted October 1, 2026 effective date for both. On July 24, 2026, CMS granted a HCPCS code for PYLARIFY TruVu, with an effective date of October 1, 2026.
Current wording
Our strategy to support the continued growth of our PSMA PET franchise included the approval and planned commercialization of a new formulation of our F-18 PSMA PET imaging agent, including obtaining TPT Status for this formulation. On March 6, 2026, the FDA approved this new formulation, PYLARIFY TruVu, which is designed to enhance product stability at higher radioactive concentrations and support more efficient manufacturing and broader distribution. PYLARIFY TruVu is expected to become commercially available beginning in the fourth quarter of 2026 and will be introduced on a rolling geographic basis, with the intent to transition customers from PYLARIFY to PYLARIFY TruVu.
Previous wording
Continued substantial revenue contribution from PYLARIFY depends on our ability to maintain PYLARIFY as a widely utilized PSMA PET imaging agent in an increasingly competitive diagnostic imaging landscape. PYLARIFY’s competition includes three Ga-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 following the expiration of PYLARIFY’s new chemical entity exclusivity period in 2026 could further increase competition, along with the continued development of additional F-18 and Ga-68 tracers and PSMA-targeted agents using alternative isotopes, including Copper-64. We continue to make targeted investments to support PYLARIFY awareness, adoption, and appropriate clinical use.
Current wording
Continued substantial revenue contribution from our PSMA PET imaging agents depends on our ability to maintain PYLARIFY, and then PYLARIFY TruVu, as a widely utilized PSMA PET imaging agent in an increasingly competitive diagnostic imaging landscape. PYLARIFY’s competition includes three Ga-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 following the expiration of PYLARIFY’s new chemical entity exclusivity period in May 2026 could further increase competition, along with the continued development of additional F-18 and Ga-68 tracers and PSMA-targeted agents using alternative isotopes, including Copper-64. We continue to make targeted investments to support PYLARIFY awareness, adoption, and appropriate clinical use.
Previous wording
Continued substantial 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 the related 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 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 patients with traditional Medicare FFS insurance coverage who are treated in the hospital outpatient setting. In November 2025, CMS released the final rule for its calendar year 2026 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2026 OPPS Rule”), which continues to provide for separate payment for diagnostic radiopharmaceuticals with per day costs greater than $655 based on their MUC. As a result, since January 1, 2025, CMS has maintained 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 patients with traditional Medicare FFS in the hospital outpatient setting, generally will be paid separately based on ASP plus six percent rather than on MUC. In November 2025, in the preamble to the CMS 2026 OPPS Rule, CMS acknowledged that there could be value in the use of Average Sales Price (“ASP”) for determining separately paid diagnostic radiopharmaceutical payment amounts in the future. However, CMS will continue to use MUC to calculate payment for diagnostic radiopharmaceuticals in 2026, explaining that there must be more consistent, validated, and universal reporting of ASP data for diagnostic radiopharmaceuticals before ASP can be the basis for payment. CMS reiterated in the CMS 2026 OPPS Rule that, although ASP reporting for diagnostic radiopharmaceuticals remains voluntary at this time, it will continue to evaluate whether and how ASP could be used for future Medicare Outpatient Prospective Payment System (“OPPS”) payment o…
Excerpt shortened here; the source contains the full paragraph.
Current wording
Continued substantial revenue contribution from our PSMA PET imaging agents will also depend on our ability to clinically differentiate them from competitive products so that customers continue to choose our PSMA PET imaging agents for appropriate patients because of their clinical differentiation and, in the case of PYLARIFY, despite the loss of TPT Status and the related changes to Medicare fee-for-service (“FFS”) hospital outpatient payment. Our Healthcare Common 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 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 patients with traditional Medicare FFS insurance coverage who are treated in the hospital outpatient setting. In November 2025, CMS released the final rule for its calendar year 2026 Medicare Hospital Outpatient Prospective Payment System (the “CMS 2026 OPPS Rule”), which continues to provide for separate payment for diagnostic radiopharmaceuticals with per day costs greater than $655 based on their MUC. As a result, since January 1, 2025, CMS has maintained 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 patients with traditional Medicare FFS in the hospital outpatient setting, generally will be paid separately based on average sales price (“ASP”) plus six percent rather than on MUC. In November 2025, in the preamble to the CMS 2026 OPPS Rule, CMS acknowledged that there could be value in the use of ASP for determining separately paid diagnostic radiopharmaceutical payment amounts in the future. However, CMS will continue to use MUC to calculate payment for diagnostic radiopharmaceuticals in 2026, explaining that there must be more consistent, validated, and universal reporting of ASP data for diagnostic radiopharmaceuticals before ASP can be the basis for payment. CMS reiterated in the CMS 2026 OPPS Rule that, although ASP reporting for diagnostic radiopharmaceuticals remains voluntary at this time, it will continue to evaluate whether and how ASP could be used for future Medicare O…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
Internationally, we have licensed exclusive rights to Curium Pharma (“Curium”) to develop and commercialize piflufolastat F-18 in Europe, where it is marketed in the European Union under the brand name PYLCLARI. In September 2025, we entered into an exclusive licensing agreement with GE Healthcare to develop, manufacture, and commercialize piflufolastat F-18 in Japan for prostate cancer diagnostics and companion diagnostic use. We have also 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”of our Form 10-K for the year ended December 31, 2025.
Current wording
Internationally, we have licensed exclusive rights to Curium Pharma, an affiliate of the Parent, to develop and commercialize piflufolastat F-18 in Europe, where it is marketed in the European Union under the brand name PYLCLARI. During the third quarter of 2026, we expanded the license to cover 56 additional countries across Africa, the Middle East, Asia-Pacific, Latin America, and other international growth markets. In September 2025, we entered into an exclusive licensing agreement with GE HealthCare to develop, manufacture, and commercialize piflufolastat F-18 in Japan for prostate cancer diagnostics and companion diagnostic use. We have also 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 is provided under Part I, Item 1. “Business - Strategic Partnerships and Other Revenue – Oncology”of our Form 10-K for the year ended December 31, 2025.
Previous wording
In addition, Neuraceq utilization may be influenced by reimbursement dynamics in the hospital outpatient setting. Medicare reimbursement for Neuraceq is comparatively lower to that of competitors, which could affect customer purchasing decisions.
Current wording
In addition, Neuraceq utilization may be influenced by reimbursement dynamics in the hospital outpatient setting. Medicare reimbursement for Neuraceq is comparatively lower than that of competitors, which could affect customer purchasing decisions.
Previous wording
We continue to seek ways to 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 product opportunities in oncology, neurology, and other strategic areas that will complement our existing portfolio.
Current wording
We continue to seek ways to increase the overall value of our portfolio of products and product candidates. We evaluate 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 product opportunities in oncology, neurology, and other strategic areas that will complement our existing portfolio.
Previous wording
Our Strategic Partnerships and Other Revenue category includes our Strategic Partnerships, Digital Solutions, PharmaSolutions and CDMO services and is focused on enabling precision medicine with biomarkers, digital solutions and CDMO services.
Current wording
Our Strategic Partnerships and Other Revenue category includes our Strategic Partnerships, Digital Solutions, Pharma Solutions and CDMO services and is focused on enabling precision medicine with biomarkers, digital solutions and CDMO services.
Previous wording
PharmaSolutions – We use our PharmaSolutions 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 PharmaSolutions 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.
Current wording
Pharma Solutions – We use our Pharma 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 Pharma 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.
Previous wording
For PYLARIFY, we are reviewing data from 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. In late 2025, we discontinued a study using piflufolastat to diagnose and describe the extent of clear cell renal carcinoma in patients due to enrollment and timeline challenges and not for safety reasons as we prioritized resources towards programs with more feasible development paths.
Current wording
For PYLARIFY, we are evaluating whether PYLARIFY can detect the presence or absence of additional prostate cancer lesions in patients with favorable intermediate-risk prostate cancer, as well as its potential impact on intended patient management. In late 2025, we discontinued a study using piflufolastat to diagnose and describe the extent of clear cell renal carcinoma in patients due to enrollment and timeline challenges and not for safety reasons as we prioritized resources towards programs with more feasible development paths.
Previous wording
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 will potentially make additional payments as described below. We also filed an 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, 2025. In March 2026, we announced that the FDA granted tentative approval of the ANDA for PNT2003.
Current wording
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 will potentially make additional payments as described below. We also filed an ANDA for PNT2003 as described further in the section entitled“Exclusive License for PNT2002 and PNT2003”
Previous wording
For LNTH-2501, we acquired the rights to the investigational asset in the Evergreen Acquisition. In October 2025, the FDA established a PDUFA target action date of March 29, 2026, for the NDA for LNTH‑2501, which was submitted under the FDA’s 505(b)(2) regulatory pathway. On March 17, 2026, we announced that the FDA extended its review of the NDA by three months, resulting in a revised PDUFA target action date of June 29, 2026. On June 26, 2026, we announced that the FDA issued a CRL regarding the NDA, stating that the agency could not approve the NDA by the June 29, 2026 extended PDUFA target action date due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the LNTH-2501 NDA may be approved. The CRL did not identify any concerns regarding the data we submitted in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.
Current wording
For LNTH-2501, we acquired the rights to the investigational asset in the Evergreen Acquisition. In October 2025, the FDA established a PDUFA target action date of March 29, 2026, for the NDA for LNTH‑2501, which was submitted under the FDA’s 505(b)(2) regulatory pathway. On March 17, 2026, we announced that the FDA extended its review of the NDA by three months, resulting in a revised PDUFA target action date of June 29, 2026. On June 26, 2026, we announced that the FDA issued a CRL regarding the NDA, stating that the agency could not approve the NDA by the June 29, 2026 extended PDUFA target action date due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions and approval of a resubmitted NDA is required before the LNTH-2501 NDA may be approved. The CRL did not identify any concerns regarding the data we submitted in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.
Previous wording
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. 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 supported an NDA submission to the FDA that we filed during the third quarter of 2025. The FDA accepted our NDA and set a PDUFA target action date of August 13, 2026.
Current wording
For MK-6240, we acquired the right to the investigational asset for an upfront payment of $35.3 million in February 2023, an additional $10.0 million in May 2023 upon the successful completion of a technology transfer and $13.0 million in September 2026 upon FDA approval of MK-6240. We could potentially make additional milestone and royalty payments in the future. 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 supported an NDA submission to the FDA that we filed during the third quarter of 2025. The FDA accepted our NDA and set a PDUFA target action date of August 13, 2026 and on August 14, 2026, we announced the FDA approval of TAUKLARIFY (florquinitau F-18 injection), also referred to as MK-6240. TAUKLARIFY is indicated for PET imaging of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify patients with tau neurofibrillary tangle pathology.
Previous wording
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. 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.
Current wording
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. 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 Technologies, Inc. (which has subsequently merged with and into Cerveau) related to NAV-4694.
Previous wording
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, incurred €10.0 million in regulatory milestones in 2025, and could potentially make additional milestone and royalty payments in the future. We plan to initiate our registrational program for LNTH-2401 in patients with prostate cancer this year.
Current wording
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, incurred €10.0 million in regulatory milestones in 2025, and could potentially make additional milestone and royalty payments in the future. On September 28, 2026, we announced that the first patient has been dosed in SPARROW, a Phase 2/3 registrational trial evaluating LNTH-2401. LNTH-2401 is an investigational Ga-68-labeled PET imaging agent that targets GRPR, a biomarker that is highly expressed in many prostate cancers.
Previous wording
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. The rights we acquired included exclusive license rights from third-party licensors. We ultimately were assigned all intellectual property rights to LNTH-2403 from the original third-party licensor and have certain financial obligations in the form of license fees and indemnification provisions to the third-party licensor as a result of that assignment. We submitted an IND application for LNTH-2403 and have initiated a Phase 1/2 multi-center, open-label study in participants with relapsed / refractory osteosarcoma.
Current wording
For LNTH-2403, we acquired the rights to the preclinical asset and the underlying license agreements, along with another asset, for $2.0 million in the aggregate, and will potentially make additional milestone and royalty payments. The rights we acquired included exclusive license rights from third-party licensors. We ultimately were assigned all intellectual property rights to LNTH-2403 from the original third-party licensor and have certain financial obligations in the form of license fees and indemnification provisions to the third-party licensor as a result of that assignment. We submitted an investigational new drug application for LNTH-2403 and have initiated a Phase 1/2 multi-center, open-label study in participants with relapsed/refractory osteosarcoma.
Previous wording
See Note 17,“Acquisitions” in our condensed consolidated financial statements herein for additional information on potential milestone and royalty payments related to the product candidates listed above.
Current wording
See Note 18,“Acquisitions” in our condensed consolidated financial statements herein and Note 19,”Acquisitions” in our consolidated financial statements in our Form 10-K for additional information on potential milestone and royalty payments related to the product candidates listed above.
Previous wording
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 pre-specified 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.
Current wording
Under the terms of the license and collaboration agreement between Lantheus Two and POINT Biopharma Global Inc. (“POINT”), dated November 11, 2022, we paid 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 pre-specified 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.
Previous wording
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.
Current wording
Under the terms of the license and collaboration agreement between Lantheus Three and POINT, dated November 11, 2022 we paid POINT an upfront payment of $10.0 million in December 2022 and will pay another $10.0 million in the fourth quarter of 2026 upon the final regulatory approval for BRAVNETSA, previously known as PNT2003, announced on September 22, 2026. We could pay up to an additional $24.5 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.
Previous wording
The increase in revenues for the three months ended June 30, 2026, as compared to the same period of 2025, was primarily driven by revenues generated from sales of Neuraceq subsequent to our acquisition of Lantheus Biosciences in July 2025 for which there were no comparable amounts in the same period of 2025, as well as an increase in PYLARIFY and DEFINITY sales volume and from revenue generated from sales of MK-6240 for investigational use. These increases were partially offset by a decrease in net sales price of PYLARIFY in 2026 and by revenue related to the SPECT business recognized during the three months ended June 30, 2025 for which there is no comparable amount in the same period of 2026.
Current wording
The increase in revenues for the three months ended September 30, 2026, as compared to the same period of 2025, was primarily driven by an increase in revenue generated from sales of Neuraceq subsequent to our acquisition of Lantheus Biosciences in July 2025, an increase in sales volume for both PYLARIFY and DEFINITY and an increase in royalties and milestone payments received from GE HealthCare related to the commercial sales of Flyrcado. These increases were partially offset by a decrease in revenue related to the SPECT business recognized during the three months ended September 30, 2025 for which there is no comparable amount in the same period of 2026, as well as a decrease in PYLARIFY net sales price for the three months ended September 30, 2026.
Previous wording
The increase in revenue for the six months ended June 30, 2026, as compared to the same period of 2025, was primarily due to revenue generated from sales of Neuraceq subsequent to our acquisition of Lantheus Biosciences in July 2025 for which there were no comparable amounts in the same period of 2025. Additionally, an increase in revenue resulted from an increase in PYLARIFY and DEFINITY sales volume in 2026. These increases were partially offset by a decrease in revenue related to the SPECT business recognized during the six months ended June 30, 2025 for which there is no comparable amount in 2026, a decrease in net sales price of PYLARIFY in 2026 and to a milestone achievement for the first commercial sale of Flyrcado by GE Healthcare in 2025 for which there was no comparable amount in 2026.
Current wording
The increase in revenue for the nine months ended September 30, 2026, as compared to the same period of 2025, was primarily due to nine months of revenue generated from sales of Neuraceq subsequent to our acquisition of Lantheus Biosciences in July 2025, compared to only two plus months of revenue generated from sales of Neuraceq for the same period of 2025. Additionally, the increase in revenue reflects higher PYLARIFY and DEFINITY sales volume in 2026 and an increase in royalties and milestone payments received from GE HealthCare related to the commercial sales of Flyrcado. These increases were partially offset by a decrease in revenue related to the SPECT business recognized during the nine months ended September 30, 2025 for which there is no comparable amount in 2026, as well as a decrease in net sales price of PYLARIFY for the nine months ended September 30, 2026.
Previous wording
Estimates for rebates represent our estimated obligations under contractual arrangements with third parties. Rebate accruals are recorded in the same period the related revenue is recognized, resulting in a reduction of revenue and the establishment of a liability which is included in accrued expenses and other current liabilities in our condensed consolidated balance sheets. These rebates 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 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.
Current wording
Estimates for rebates represent our estimated obligations under contractual arrangements with third parties. Rebate accruals are recorded in the same period the related revenue is recognized, resulting in a reduction of revenue and the establishment of a liability which is included in accrued expenses and other current liabilities in our condensed consolidated balance sheets. These rebates result from performance-based offers that are primarily based on attaining contractually specified sales volumes and market share, 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 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.
Previous wording
The decrease in gross profit for the six months ended June 30, 2026, as compared to the prior year period, is primarily due to the decrease in PYLARIFY net sales price, which had a greater impact for the six-month comparison than for the three-month comparison. The remaining decreases were attributable to a decrease in gross profit from additional amortization of intangible assets resulting from the acquisition of Lantheus Biosciences, for which there were no comparable amounts recorded during the six months ended June 30, 2025, and an increase in contractual vendor pricing and the sale of our SPECT business in January 2026, offset by an increase in revenue from MK-6240 for investigational use.
Current wording
The increases in gross profit for the three months ended September 30, 2026, as compared to the prior year period, is primarily due to an increase in revenue from Neuraceq subsequent to the July 2025 acquisition of Lantheus Biosciences, increased PYLARIFY and DEFINITY sales volume, an increase in Flyrcado revenue and a decrease in costs related to corporate projects completed in 2025 for which there are no comparable costs in 2026. These increases were partially offset by a decrease in PYLARIFY net sales price, additional amortization of intangible assets resulting from the acquisition of Lantheus Biosciences and the sale of our SPECT business in January 2026.
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Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Loss (Gain) on Sale of Business, Net of Transaction Costs
Current report — wording carried from elsewhere
On July 31, 2025, our Board authorized the 2025 Program. The 2025 Program replaces the 2024 Program, including the remaining unused amounts under the 2024 Program. We repurchased 1.3 million shares for approximately $100.0 million under the 2024 Program in 2025. The 2025 Program 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
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
We did not repurchase any shares under the 2025 Program in the three or six months ended June 30, 2026. We repurchased 3.5 million shares for approximately $200.0 million under the 2025 Program, in 2025.