Q4 2025 Lantheus Holdings Inc Earnings Call

February 26, 2026

Speaker #2: Good morning. Welcome to Lantheus 4th Quarter and Full Year 2025 Conference Call. All lines have been placed on mute. This call is being recorded and a replay of will be available in the investors section of the company's website approximately 2 hours after the completion of the call, and we will be archived for at least 30 days.

Speaker #2: I'll now turn the call over to Mark Kinarney, Vice President of Investor Relations. Mark?

Speaker #3: Thank you. Good morning. With me today are Marianne Haeno, our CEO and Executive Chairperson; Amanda Morgan, our Chief Commercial Officer; and Bob Marshall, our CFO.

Speaker #3: We will begin with prepared remarks and then take your questions. This morning, we issued a press release which was furnished to the SEC under Form 8-K, reporting our fourth quarter and full year 2025 results.

Operator: Good morning. Welcome to Lantheus' Fourth Quarter and Full Year 2025 Conference Call. All lines have been placed on mute. This call is being recorded and a replay will be available in the Investors section of the company's website approximately 2 hours after the completion of the call, and will be archived for at least 30 days. I'll now turn the call over to Mark Guarnieri, Vice President of Investor Relations. Mark?

Operator: Good morning. Welcome to Lantheus' Q4 and Full Year 2025 Conference Call. All lines have been placed on mute. This call is being recorded and a replay will be available in the Investors section of the company's website approximately 2 hours after the completion of the call, and will be archived for at least 30 days. I'll now turn the call over to Mark Guarnieri, Vice President of Investor Relations. Mark?

Speaker #3: The release and today's slide presentation are available on the investors section of our website. Any comments could include forward-looking statements, actual results may differ materially from these statements, due to a variety of risks and uncertainties, which are detailed in our SEC filings.

Speaker #3: Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the investors section of our website.

Mark Guarnieri: Thank you. Good morning. With me today are Mary Anne Heino, our CEO and Executive Chairperson, Amanda Morgan, our Chief Commercial Officer, and Bob Marshall, our CFO. We will begin with prepared remarks and then take your questions. This morning, we issued a press release, which was furnished to the SEC under Form 8-K, reporting our Q4 and full year 2025 results. The release and today's slide presentation are available on the Investors section of our website. Any comments could include forward-looking statements. Actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings. Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investors section of our website. I will now turn the call over to Mary Anne.

Mark Kinarney: Thank you. Good morning. With me today are Mary Anne Heino, our CEO and Executive Chairperson, Amanda Morgan, our Chief Commercial Officer, and Bob Marshall, our CFO. We will begin with prepared remarks and then take your questions. This morning, we issued a press release, which was furnished to the SEC under Form 8-K, reporting our Q4 and full year 2025 results. The release and today's slide presentation are available on the Investors section of our website. Any comments could include forward-looking statements. Actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings. Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investors section of our website. I will now turn the call over to Mary Anne.

Speaker #3: I will now turn the call over to Marianne.

Speaker #4: Thank you, Mark. And good morning, everyone. It's a pleasure to be back with you as CEO at an important moment for the company. I want to start by recognizing Brian for his leadership and for ensuring a smooth transition.

Speaker #4: While my role as CEO will be interim as we complete the search for the next Lantheus CEO, I'm thrilled to be back in the operational leadership role with the same passion and commitment that those who work with me will remember.

Speaker #4: I have taken time to meet with shareholders over the past months and appreciate the ongoing opportunity to listen to your feedback. My intent is to seamlessly transition our strategy and the execution of that strategy to the incoming CEO.

Speaker #4: I will note the board and I are successfully progressing our CEO search, and I am pleased with the candidates we have met thus far.

Mary Anne Heino: Thank you, Mark, good morning, everyone. It's a pleasure to be back with you as CEO at an important moment for the company. I want to start by recognizing Brian for his leadership and for ensuring a smooth transition. While my role as CEO will be interim as we complete the search for the next Lantheus CEO, I'm thrilled to be back in the operational leadership role with the same passion and commitment that those who work with me will remember. I have taken time to meet with shareholders over the past months and appreciate the ongoing opportunity to listen to your feedback. My intent is to seamlessly transition our strategy and the execution of that strategy to the incoming CEO. I will note, the board and I are successfully progressing our CEO search, I am pleased with the candidates we have met thus far.

Speaker #4: Before I offer comments about our business achievements for 2025, I would first like to share that Lantheus products help impact the lives of approximately 7 million patients in 2025.

Speaker #4: Underscoring the real-world importance of the work our teams do every day. Now, turning to the results, I would like to start by highlighting the important progress we made in 2025 to shape our strategic focus within the radiopharmaceutical industry.

Speaker #4: The decisive actions we took in 2025 include: we closed two complementary transactions that diversified and will accelerate our near-term revenue streams across our commercial radio diagnostic portfolio.

Mary Anne Heino: Before I offer comments about our business achievements for 2025, I would first like to share that Lantheus products helped impact the lives of approximately 7 million patients in 2025, underscoring the real-world importance of the work our teams do every day. Now, turning to the results, I would like to start by highlighting the important progress we made in 2025 to shape our strategic focus within the radiopharmaceutical industry. The decisive actions we took in 2025 include: We closed two complementary transactions that diversified and will accelerate our near-term revenue stream across our commercial radiodiagnostic portfolio. First, the acquisition of Neuraceq, our beta-amyloid-targeted PET radiodiagnostic, which now serves as the commercial cornerstone of our Alzheimer's disease portfolio. We are excited both about the growth potential of Neuraceq and the expanding amyloid PET imaging market.

Speaker #4: First, the acquisition of Neuroseek, our beta amyloid-targeted pet radio diagnostic. Which now serves as the commercial cornerstone of our Alzheimer's disease portfolio. We are excited both about the growth potential of Neuroseek and the expanding amyloid pet imaging market.

Speaker #4: And in 2026, we expect Neuroseek's growth will exceed that of the overall market. Second, our acquired product candidate Octavie. A neuroendocrine pet radio diagnostic currently under FDA review.

Speaker #4: Upon approval, Octavie will enter the well-established gastroenteropancreatic, or GEPNET, pet imaging market. This product fully complements our nuclear medicine customer base and allows us to broaden our offering to the customers we already engage with for polarify and Neuroseek.

Speaker #4: In 2025, we also took meaningful steps to further build out the portfolio of radio diagnostic products Lantheus offers to the prostate cancer community. Our primary focus in 2025 was defending our leadership position in the PSMA pet imaging space with polarify.

Mary Anne Heino: In 2026, we expect Neuraceq's growth will exceed that of the overall market. Second, our acquired product candidate, Octevi, a neuroendocrine PET radiodiagnostic currently under FDA review. Upon approval, Octevi will enter the well-established gastroenteropancreatic, or GEP-NET, PET imaging market. This product fully complements our nuclear medicine customer base and allows us to broaden our offerings to the customers we already engage with for PYLARIFY and Neuraceq. In 2025, we also took meaningful steps to further build out the portfolio of radiodiagnostic products Lantheus offers to the prostate cancer community. Our primary focus in 2025 was defending our leadership position in the PSMA PET imaging space with PYLARIFY, and we believe that position will serve as a key advantage as we prepare the market for our new formulation later this year.

Speaker #4: And we believe that position will serve as a key advantage as we prepare the market for our new formulation later this year. This past year, we also advanced Lantheus' 2401, our Phase III ready gastrin-releasing peptide receptor, or GRPR, targeted radio diagnostic for prostate cancer.

Speaker #4: GRPR is a biologically distinct target from PSMA. And an estimated 15 to 30 percent of prostate cancer patients do not express PSMA. Lantheus' 2401 has the potential to complement PSMA pet imaging by identifying disease in patients who may be PSMA negative or equivocal, extending the addressable population while fitting within our existing prostate cancer franchise.

Speaker #4: That transition will take place with these acquisitions and the other activities accomplished to build out our pipeline. We believe that Lantheus now has the broadest radio diagnostic pipeline among our peers in the radiopharmaceutical space.

Mary Anne Heino: This past year, we also advanced Lantheus 2401, our phase 3-ready gastrin-releasing peptide receptor, or GRPR, targeted radiodiagnostic for prostate cancer. GRPR is a biologically distinct target from PSMA, and an estimated 15% to 30% of prostate cancer patients do not express PSMA. Lantheus 2401 has the potential to complement PSMA PET imaging by identifying disease in patients who may be PSMA negative or equivocal, extending the addressable population while fitting within our existing prostate cancer franchise. With these acquisitions and the other activities accomplished to build out our pipeline, we believe that Lantheus now has the broadest radiodiagnostic pipeline among our peers in the radiopharmaceutical space. Finally, we completed the divestiture of our legacy SPECT business on 1 January 2026.

Speaker #4: Finally, we completed the divestiture of our legacy spec business on January 1st of 2026. While the spec business was foundational to Lantheus' renowned reputation in nuclear medicine over many decades, our strategic intent is to prioritize investment in and the commercialization of innovative pet radio diagnostics on a forward basis.

Speaker #4: For having narrowed our strategic focus to radio diagnostics, we believe we can deliver sustainable and attractive revenue growth in the mid and long term.

Speaker #4: Looking ahead to 2026, we are fully focused on commercial execution and revenue generation with our current commercialized assets. As well as successfully advancing a number of approval milestones for our registrational stage products.

Speaker #4: Our top priority is to maintain and strengthen our leadership in PSMA pet by sustaining polarify volume growth while preparing the market for the launch of our new PSMA pet formulation.

Mary Anne Heino: While the SPECT business was foundational to Lantheus' renowned reputation in nuclear medicine over many decades, our strategic intent is to prioritize investment in, and the commercialization of innovative PET radiodiagnostics on a forward basis. Having narrowed our strategic focus to radiodiagnostics, we believe we can deliver sustainable and attractive revenue growth in the mid and long term. Looking ahead to 2026, we are fully focused on commercial execution and revenue generation with our current commercialized assets, as well as successfully advancing a number of approval milestones for our registrational stage products. Our top priority is to maintain and strengthen our leadership in PSMA PET by sustaining PYLARIFY volume growth while preparing the market for the launch of our new PSMA PET formulation. That transition will take place in the Q4 of 2026, with the material commercial impact of that launch beginning in 2027.

Speaker #4: That transition will take place in the fourth quarter of 2026, with the materials commercial impact of that launch beginning in 2027. In neurology, we are excited to drive momentum with Neuroseek through expansion of our PMF manufacturing network, as well as the opportunity of introducing Neuroseek to our existing nuclear medicine polarify customers.

Speaker #4: Neuroseek, as well as the radio diagnostic products currently under FDA review, will be offered to our nuclear medicine customer base as part of a comprehensive portfolio of Lantheus products in 2026 and beyond.

Speaker #4: We have the potential for multiple FDA approvals this year. The first, our new PSMA PET formulation; second, Octavie; third, PNT2003, our radio-equivalent formulation of Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors, or GEPNET; and fourth, MK6240, our tau-targeted PET radio diagnostic.

Mary Anne Heino: In neurology, we are excited to drive momentum with Neuraceq through expansion of our PMS manufacturing network, as well as the opportunity of introducing Neuraceq to our existing nuclear medicine PYLARIFY customers. Neuraceq, as well as the radiodiagnostic products currently under FDA review, will be offered to our nuclear medicine customer base as part of a comprehensive portfolio of Lantheus' products in 2026 and beyond. We have the potential for multiple FDA approvals this year. The first, our new PSMA PET formulation, second, Octevi, third, PNT2003, our radio equivalent formulation of LUTATHERA for the treatment of gastroenteropancreatic neuroendocrine tumors or GEPNET, and fourth, MK-6240, our tau-targeted PET radiodiagnostic. Assuming approval for each of these products, the commercialization plan will be thoroughly targeted to align with market and access readiness, an approach we believe underpinned our successful PYLARIFY launch.

Speaker #4: Assuming approval for each of these products, the commercialization plan will be thoroughly targeted to align with market and access readiness and approach we believe underpinned our successful polarify launch.

Speaker #4: We are able to leverage our PMF network and commercial infrastructure. Investing in line with the expected revenue growth opportunity of each product in 2027.

Speaker #4: And beyond. As I have already mentioned, our strategy and related investment going forward will focus on radio diagnostics. As a result, we are optimizing our cost structure to match this focus.

Speaker #4: Enabling us to deliver on the EPS targets we announced today, while leaving additional opportunity to further improve that profile in the future. We are selectively prioritizing first and best-in-class later-stage PET radio diagnostic assets that complement our current commercialized portfolio and our nuclear medicine customer base.

Mary Anne Heino: We are able to leverage our PMS network and commercial infrastructure, investing in line with the expected revenue growth opportunity of each product in 2027 and beyond. As I've already mentioned, our strategy and related investments going forward will focus on radiodiagnostics. As a result, we are optimizing our cost structure to match this focus, enabling us to deliver on the EPS targets we announced today, while leaving additional opportunity to further improve that profile in the future. We are selectively prioritizing first and best-in-class later-stage PET radiodiagnostic assets that complement our current commercialized portfolio and our nuclear medicine customer base. As part of this strategy, we have decided to pursue value-maximizing alternatives for the radiotherapeutic assets in our pipeline.

Speaker #4: As part of this strategy, we have decided to pursue value-maximizing alternatives for the radiotherapeutic assets in our pipeline. Given the broad portfolio we have built to date, we do not anticipate pursuing any significant M&A activity in 2026.

Speaker #4: Though we remain open to opportunistic tuck-in acquisitions of portfolio-aligned diagnostics. Our priority is to complete the integration of our recent transactions early in 2026 to fully capture their value.

Speaker #4: As of I have outlined, 2026 will be a year of commercial execution and regulatory milestones as we focus our efforts and investments to serve our nuclear medicine customers.

Speaker #4: With strong mid and long-term revenue drivers, a robust late-stage pipeline, and a clear strategic roadmap, we are confident in our ability to drive meaningful performance gains that support a compelling mid and long-term outlook for our shareholders.

Mary Anne Heino: Given the broad portfolio we have built to date, we do not anticipate pursuing any significant M&A activity in 2026, though we remain open to opportunistic tuck-in acquisitions of portfolio-aligned diagnostics. Our priority is to complete the integration of our recent transactions early in 2026 to fully capture their value. As I have outlined, 2026 will be a year of commercial execution and regulatory milestones as we focus our efforts and investments to serve our nuclear medicine customers. With strong mid and long-term revenue drivers, a robust late-stage pipeline, and a clear strategic roadmap, we are confident in our ability to drive meaningful performance gains that support a compelling mid and long-term outlook for our shareholders. Let me now hand over to Amanda, who will offer highlights on performance and commercial execution across our portfolio in oncology, neurology, and cardiology.

Speaker #4: Let me now hand over to Amanda, who will offer highlights on performance and commercial execution across our portfolio in oncology, neurology, and cardiology. She will then provide an update on our late-stage diagnostic pipeline.

Speaker #4: Amanda, thank you, Marianne. We are positioning the business for its continued growth by driving commercial readiness ahead of multiple upcoming launches beginning with our new PSMA pet formulation.

Speaker #4: First, let's discuss our fourth quarter results and priorities for 2026. I'll begin with Polarify. Our market-leading agent, which posted solid performance in the fourth quarter in a highly competitive market with volume up approximately 4% year over year.

Speaker #4: Our continued successful commercial execution and pricing discipline were the drivers of this performance. Notably, the vast majority of our annual volume in 2025 came from long-standing accounts demonstrating the resilience and commitment of our customer base and the clinical value of Polarify.

Mary Anne Heino: She will provide an update on our late-stage diagnostic pipeline. Amanda?

Amanda Morgan: Thank you, Mary Anne. We are positioning the business for its continued growth by driving commercial readiness ahead of multiple upcoming launches, beginning with our new PSMA PET formulation. First, let's discuss our Q4 results and priorities for 2026. I'll begin with PYLARIFY, our market-leading agent, which posted solid performance in the Q4 in a highly competitive market, with volume up approximately 4% year-over-year. Our continued successful commercial execution and pricing discipline were the drivers of this performance. Notably, the vast majority of our annual volume in 2025 came from long-standing accounts, demonstrating the resilience and commitment of our customer base and the clinical value of PYLARIFY. As a reminder, pricing concessions provided late in the Q2 of 2025 reset 340B pricing in the Q4.

Speaker #4: As a reminder, pricing concessions provided late in the second quarter of 2025 reset 340B pricing in the fourth quarter. Our best price, which determines what is offered as 340B pricing, was unchanged in the second half of 2025.

Speaker #4: Therefore, there will be no further change to our 340B pricing in the first half of 2026. We believe we have the broadest end-to-end coverage of PSMA pet imaging value chain delivering consistent availability, reliability, and dependability to our customers.

Speaker #4: This level of operational excellence is a clear source of competitive advantage. We will extend this proven capability across each product we launch into the radio diagnostic market, with the intent to accelerate adoption and drive both mid- and long-term growth.

Amanda Morgan: Our best price, which determines what is offered as 340B pricing, was unchanged in the second half of 2025. Therefore, there will be no further change to our 340B pricing in the first half of 2026. We believe we have the broadest end-to-end coverage of PSMA PET imaging value chain, delivering consistent availability, reliability, and dependability to our customers. This level of operational excellence is a clear source of competitive advantage. We will extend this proven capability across each product we launch into the radiodiagnostic market, with the intent to accelerate adoption and drive both mid and long-term growth. Now I will highlight performance of our commercialized Alzheimer's imaging product. Neuraceq contributed $31 million for the quarter, driven by strong commercial execution. In 2026, we will further support that execution with the onboarding of 6 additional PMS sites.

Speaker #4: Now I will highlight performance of our commercialized Alzheimer's imaging products. Neuroseek contributed $31 million for the quarter. Driven by strong commercial execution, in 2026 we will further support that execution with the onboarding of six additional PMF sites.

Speaker #4: We are excited about the potential of Neuroseek in the Alzheimer's disease PET imaging market. As we are already the second most utilized and fastest-growing beta-amyloid PET imaging agent, Neuroseek addresses a large and expanding opportunity.

Speaker #4: With more than 7 million people currently diagnosed with dementia in the U.S., demand for amyloid PET imaging is increasing, driven both by the adoption of Alzheimer's disease-modifying therapies, or DMTs, as well as by guideline expansion for diagnostic use earlier in the care pathway for patients with mild cognitive impairment and early Alzheimer's disease.

Amanda Morgan: We are excited about the potential of Neuraceq in Alzheimer's disease PET imaging market. As the already second most utilized and fastest-growing beta amyloid PET imaging agent, Neuraceq addresses a large and expanding opportunity. With more than 7 million people currently diagnosed with dementia in the US, demand for amyloid PET imaging is increasing, driven both by the adoption of Alzheimer's disease modifying therapies or DMTs, as well as by guideline expansion for diagnostic use earlier in the care pathway for patients with mild cognitive impairment, and early Alzheimer's disease. Finally, DEFINITY remained a strong contributor to our overall performance and delivered over $85 million in Q4. 2026 marks DEFINITY's 25th year on the market. It remains firmly positioned as the market leader with more than 80% share. Now turning to our promising late-stage pipeline.

Speaker #4: Finally, Definity remained a strong contributor to our overall performance and delivered over 85 million in the fourth quarter. 2026 marks Definity's 25th year on the market, and it remains firmly positioned as the market leader with more than 80% share.

Speaker #4: Now, turning to our promising late-stage pipeline. 2026 is a critical and exciting year for commercial launch preparedness for several of our registrational-stage assets.

Speaker #4: Specific to radio diagnostics, it is important to align investment and launch timing with market access and value chain readiness to optimally realize the commercial opportunity.

Speaker #4: We have three radio diagnostic assets and one radio equivalent therapeutic with near-term regulatory approval timelines. First, our new PSMA pet formulation with the PDUPA date of March 6th offers the same diagnostic properties of Polarify with a similar safety and efficacy profile while delivering manufacturing efficiencies that will immediately improve supply availability.

Amanda Morgan: 2026 is a critical and exciting year for commercial launch preparedness for several of our registrational stage assets. Specific to radiodiagnostics, it is important to align investment and launch timing with market access and value chain readiness to optimally realize the commercial opportunity. We have three radiodiagnostic assets and one radioequivalent therapeutic with near-term regulatory approval timelines. First, our new PSMA PET formulation, with a PDUFA date of March 6th, offers the same diagnostic properties of PYLARIFY with a similar safety and efficacy profile, while delivering manufacturing efficiencies that will immediately improve supply availability. As with any F-18 radiodiagnostic, launch timing and success depends on having broad PMS network in place as our focus will be on supply continuity.

Speaker #4: And as with any F18 radio diagnostic, launch timing and success depend on having a broad PMF network in place, as our focus will be on supply continuity.

Speaker #4: A central tenant of our launch strategy is to ensure we have coding, transitional pass-through status, and broad payer coverage in place before commercial launch.

Speaker #4: Thereby ensuring customers have access to, and coverage for, the new formulation. By leveraging our already established infrastructure and strong nuclear medicine customer relationships, our goal is to ensure the transition from Polarify to our new formulation will be a seamless experience, while providing what will be the only F18-based product in the PSMA imaging category with transitional pass-through reimbursement.

Speaker #4: This approach informed by our deep experience in radio diagnostics we executed on a rolling regional basis in the fourth quarter of 2026. Which will minimize risk during the commercial launch.

Amanda Morgan: A central tenet of our launch strategy is to ensure we have coding, Transitional Pass-Through status, and broad payer coverage in place before commercial launch, thereby ensuring customers have access to and coverage for the new formulation. By leveraging our already established infrastructure and strong nuclear medicine customer relationships, our goal is to ensure the transition from PYLARIFY to our new formulation will be a seamless experience, while providing what will be the only F-18-based product in the PSMA imaging category with Transitional Pass-Through reimbursement. This approach, informed by our deep experience in radiodiagnostics, will be executed on a rolling regional basis in Q4 2026, which will minimize risk during the commercial launch. We believe these actions position a new formulation for continuous, sustainable growth beginning in 2027.

Speaker #4: We believe these actions position the new formulation for continuous sustainable growth beginning in 2027. Second, Octevi, our gallium-based pet radio diagnostic for nets. With the PDUPA date of March 29th, we'll support clinical decision-making and patients with neuroendocrine tumors.

Speaker #4: Assuming FDA approval, we will have the opportunity to launch Octevi as the only neuroendocrine PET radio diagnostic with transitional pass-through reimbursement. As a gallium-based agent, Octevi will be offered through existing radiopharmacy networks, which Lantheus has long-standing relationships with.

Speaker #4: Our team is eager to begin the launch process for both agents in the second half of this year with the expectation that they will begin to have a material impact on our performance in 2027.

Amanda Morgan: Second, Occevi, our gallium-based PET radiodiagnostic for NETs, with a PDUFA date of 29 March, will support clinical decision-making in patients with neuroendocrine tumors. Assuming FDA approval, we will have the opportunity to launch Occevi as the only neuroendocrine PET radiodiagnostic with transitional pass-through reimbursement. As a gallium-based agent, Occevi will be offered through existing radio pharmacy networks, which Lantheus has long-standing relationships with. Our team is eager to begin the launch process for both agents in the second half of this year, with the expectation that they will begin to have a material impact on our performance in 2027. Turning to PNT2003, our registrational stage radioequivalent therapeutic to LUTATHERA. We are awaiting FDA approval and anticipate a court ruling mid-year on our Hatch-Waxman litigation.

Speaker #4: Turning to PMT2003, our registrational stage radio equivalent therapeutic to Lutathera. We are awaiting FDA approval and anticipate a court ruling mid-year on our Hatch Waxman litigation.

Speaker #4: PMT2003, like Octevi, will be a natural addition to the Lantheus commercial portfolio of products, offered to our nuclear medicine customer base. Enabling portfolio leverage across this common customer.

Speaker #4: MK6240, our registrational stage tau-targeted pet radio diagnostic for Alzheimer's disease. Currently represents an important asset within our biomarker solutions portfolio and is the leading imaging agent supporting late-stage Alzheimer's DMT development.

Speaker #4: It is currently the most widely used imaging agent in amyloid and tau-targeted therapeutic candidate clinical programs. MK6240 currently serves as the imaging agent for treatment eligibility in 17 pharma-sponsored therapeutic programs.

Amanda Morgan: PNT2003, like Occevi, will be a natural addition to the Lantheus commercial portfolio of products offered to our nuclear medicine customer base, enabling portfolio leverage across this common customer. MK-6240, our registrational stage tau-targeted PET radiodiagnostic for Alzheimer's disease, currently represents an important asset within our biomarker solutions portfolio and is the leading imaging agent supporting late-stage Alzheimer's DMT development. It is currently the most widely used imaging agent in amyloid and tau-targeted therapeutic candidate clinical programs. MK-6240 currently serves as the imaging agent for treatment eligibility in 17 pharma-sponsored therapeutic programs. The PDUFA date for MK-6240 is 13 August of this year. Collectively, our registrational stage assets will deliver on our strategy to maintain and expand our leadership in innovative PET radiodiagnostics and drive sustainable mid and long-term growth.

Speaker #4: The PDUPA date for MK6240 is August 13th of this year. Collectively, our registrational stage assets will deliver on our strategy to maintain and expand our leadership in innovative pet radio diagnostics and drive sustainable mid and long-term growth.

Speaker #4: In 2026, our commercial priority is clear. Maximize the value of our current product portfolio by navigating a competitive marketplace of discipline and executing upcoming launches with excellence.

Speaker #4: I'll now turn the call over to Bob to provide more detail on our fourth quarter and full-year results and outlook. Bob?

Speaker #2: Thank you, Amanda. And good morning, everyone. I will provide details of the fourth quarter and full-year 2025 financials. Focusing on adjusted results with comparisons to the prior year quarter unless otherwise noted.

Speaker #2: Revenue for the fourth quarter was $406.8 million, an increase of 4%. Revenue for the full year was $1,541.6 million, an increase of half a percent.

Amanda Morgan: In 2026, our commercial priority is clear: maximize the value of our current product portfolio by navigating a competitive marketplace with discipline and executing upcoming launches with excellence. I'll now turn the call over to Bob to provide more detail on our Q4 and full year results and outlook. Bob?

Speaker #2: Turning to the details, radio pharmaceutical oncology, currently compromised solely of Polarify, generated fourth quarter revenue of $240.2 million, flat sequentially and down 9.7%. For the full year, Polarify delivered $989.1 million, down 6.5% from the prior year period.

Bob Marshall: Thank you, Amanda, and good morning, everyone. I will provide details of the Q4 and full year 2025 financials, focusing on adjusted results with comparisons to the prior year quarter, unless otherwise noted. Revenue for the Q4 was $406.8 million, an increase of 4%. Revenue for the full year was $1,541.6 million, an increase of 0.5%. Turning to the details, Radiopharmaceutical Oncology, currently compromised solely of PYLARIFY, generated Q4 revenue of $240.2 million, flat sequentially and down 9.7%. For the full year, PYLARIFY delivered $989.1 million, down 6.5% from the prior year period. The result was above expectation, with price and volume favorability as compared to our previous estimates.

Speaker #2: The result was above expectation with price and volume favorability as compared to our previous estimates. Precision diagnostics delivered fourth quarter revenue of $143.2 million, representing a 22% increase.

Speaker #2: The category was driven by net sales of Definity at $85.3 million, or 1% lower, due to the prior year competitors' supply challenges, which drove higher-than-expected revenue during Q4 2024.

Speaker #2: For full-year results, we're $330.2 million, up 3.9%. Neuroseek delivered $31 million in the quarter and $51.4 million since the acquisition in late July. Technolite and other spec revenue for the quarter was $26.9 million for the fourth quarter and $111.4 million for the full year.

Speaker #2: Lastly, strategic partnerships and other revenue was $23.3 million, up 203.3%, due to a strong quarter for MK6240, as well as the recognition of a $6 million milestone receipt relating to an out-licensed asset.

Bob Marshall: Precision Diagnostics delivered Q4 revenue of $143.2 million, representing a 22% increase. The category was driven by net sales of DEFINITY at $85.3 million, or 1% lower, due to the prior year competitor supply challenges, which drove higher than expected revenue during Q4 2024. For full year, results were $330.2 million, up 3.9%. Neuraceq delivered $31 million in the quarter and $51.4 million since the acquisition in late July. TechneLite and other SPECT revenue for the quarter was $26.9 million for Q4 and $111.4 million for the full year.

Speaker #2: Full-year revenue was $59.4 million, with MK6240 contributing slightly less than half of that amount. Gross profit margin for the fourth quarter was 65.1%, down 289 basis points from the fourth quarter 2024, due mainly to year-over-year decreases in Polarify net price and the inclusion during 2025 of the Evergreen manufacturing facility and Neuroseek volumes.

Speaker #2: Which were not in a comparative period, all offset in part by favorable PYLARIFY dose volumes. Operating expenses, at 30.9% of net revenue, were 179 basis points unfavorable from the prior year, but within previously guided spending levels.

Bob Marshall: Lastly, strategic partnerships and other revenue was $23.3 million, up 203.3%, due to a strong quarter for MK-6240, as well as the recognition of a $6 million milestone receipt relating to an out-licensed asset. Full year revenue was $59.4 million, with MK-6240 contributing slightly less than half of that amount. Gross profit margin for Q4 was 65.1%, down 289 basis points from Q4 2024, due mainly to year-over-year decreases in PYLARIFY net price and the inclusion during 2025 of the Evergreen manufacturing facility and Neuraceq volumes, which were not in the comparative period, all offset in part by favorable PYLARIFY dose volumes.

Speaker #2: Increases in research and development, the majority of the year-over-year change. We're a continuation of our planned investments to advance our clinical stage portfolio. The sales and marketing increase, which largely due to having a full quarter of the Neuroseek sales team and related activities.

Speaker #2: GNA was flat in the period despite ongoing and the litigation expense for our PMT2003 asset and the inclusion of LMI and Evergreen operating expenses.

Speaker #2: Other income and expense was 2.3 million of expense. Operating profit for the quarter was $138.9 million, a decrease of 8.5%. Total adjustments in the quarter were $66.2 million of expense before taxes, of this amount $17.5 and $16.5 million of expense is associated with non-cash stock and incentive plans and acquired intangible amortization, respectively.

Bob Marshall: Operating expenses at 30.9% of net revenue were 179 basis points unfavorable from the prior year, within previously guided spending levels. Increases in research and development, the majority of the year-over-year change, were a continuation of our planned investments to advance our clinical stage portfolio. The sales and marketing increase was largely due to having a full quarter of the Neuraceq sales team and related activities. G&A was flat in the period, despite ongoing and a litigation expense for our PNT2003 asset and the inclusion of Life Molecular Imaging and Evergreen operating expenses. Other income and expense was $2.3 million of expense. Operating profit for the quarter was $138.9 million, a decrease of 8.5%. Total adjustments in the quarter were $66.2 million of expense before taxes.

Speaker #2: The company recorded an unrecognized loss of $9.5 million, attributed to its equity investments in prospective therapeutics and radiopharma theranostics. Additionally, the company recognized a $5 million payment in the quarter relating to the Relistor royalty stream sale, which was reflected in other income.

Speaker #2: Further, the company incurred $21.7 million in acquisition, integration, and divestiture-related costs. The remaining $6 million is related to other non-recurring expenses. Our effective tax rate was 19% in the quarter and 25.3% for the full year.

Bob Marshall: Of this amount, $17.5 million and $16.5 million of expense is associated with non-cash stock and incentive plans and acquired intangible amortization, respectively. The company recorded an unrecognized loss of $9.5 million, attributed to its equity investments in Perspective Therapeutics and Radiopharm Theranostics. Additionally, the company recognized a $5 million payment in the quarter relating to the RELISTOR royalty stream sale, which was reflected in other income. Further, the company incurred $21.7 million in acquisition, integration, and divestiture-related costs. The remaining $6 million is related to other non-recurring expenses. Our effective tax rate was 19% in the quarter and 25.3% for the full year.

Speaker #2: The resulting reported profit for the fourth quarter was $54.1 million and a profit of $110.7 million on an adjusted basis, a decrease of 4.1% from the prior year period.

Speaker #2: Gap fully diluted earnings per share for the fourth quarter were $82 and $1.67 on an adjusted basis, an increase of 4.7%. On a full-year basis, gap fully diluted earnings per share were a profit of $3.41 and a profit of $6.08 on an adjusted basis, a decrease of 10% from the prior year.

Speaker #2: Now turning to cash flow, fourth quarter operating cash flow totaled $90.2 million, as compared to $157.7 million in Q4 2024. Capital expenditures totaled $8.8 million, $7.6 million less than the prior year.

Bob Marshall: The resulting reported profit for Q4 was $54.1 million and a profit of $110.7 million on an adjusted basis, a decrease of 4.1% from the prior year period. GAAP fully diluted earnings per share for Q4 were $0.82 and $1.67 on an adjusted basis, an increase of 4.7%. On a full year basis, GAAP fully diluted earnings per share were a profit of $3.41 and a profit of $6.08 on an adjusted basis, a decrease of 10% from the prior year. Now turning to cash flow. Q4 operating cash flow totaled $90.2 million, as compared to $157.7 million in Q4 2024.

Speaker #2: Free cash flow, which we define as operating cash flow less capital expenditures, was $81.4 million. In Q4 2025, a decrease of $60 million from the prior year period.

Speaker #2: The majority of the variance lies within working capital, with a $49.3 million decrease driven primarily by the acceleration of accounts payable associated with the cutover activities for the Spec business ahead of the divestiture on July 1st.

Speaker #2: Increase in accounts receivable related to timing of sales and the go-live to a direct billing model transferred from one of our significant PMF partners, as well as an increase in inventory due to the timing of production runs and expansion of the PMF network.

Bob Marshall: CapEx totaled $8.8 million, $7.6 million less than the prior year. Free cash flow, which we define as operating cash flow less CapEx, was $81.4 million in Q4 2025, a decrease of $60 million from the prior year period. The majority of the variance lies within working capital, with a $49.3 million decrease, driven primarily by the acceleration of accounts payable associated with the cutover activities for the SPECT business ahead of the divestiture on 1 January. Increase in accounts receivable related to timing of sales and the go live to a direct billing model transferred from one of our significant PMF partners, as well as an increase in inventory due to the timing of production runs and expansion of the PMF network.

Speaker #2: Additionally, the company repurchased $100 million or $1.77 million of its own shares during the quarter. Leaving $200 million of authorization for buybacks outstanding. Lastly, cash and cash equivalents net of restricted cash now stand at $359.1 million.

Speaker #2: Before turning to our expectations of the full year 2026, there are a number of line items that we'd like to clarify to put the right context on 2025 versus 2026 comparison.

Speaker #2: Beginning with revenue, we completed the divestiture of our spec business effective January 1, 2026. As such, you should remove $111.4 million from the 2025 baseline year.

Speaker #2: Further, as mentioned, we recognize a $6 million milestone payment related to an out-licensed asset in the fourth quarter. Taken together, the comparable baseline would be $1,424.2 million.

Bob Marshall: Additionally, the company repurchased $100 million, or 1.77 million of its own shares during the quarter, leaving $200 million of authorization for buybacks outstanding. Lastly, cash and cash equivalents, net of restricted cash, now stand at $359.1 million. Before turning to our expectations for the full year of 2026, there are a number of line items that we'd like to clarify to put the right context on 2025 versus 2026 comparisons. Beginning with revenue, we completed the divestiture of our SPECT business effective 1 January 2026. As such, you should remove $111.4 million from the 2025 baseline year. Further, as mentioned, we recognized a $6 million milestone payment related to an out-licensed asset in Q4.

Speaker #2: The EPS impact on these adjustments equates to approximately 16 cents. Operating expenses also required normalization adjustments for comparison's sake as well. During 2025, the company reduced accrued expense resulting in approximately 14 cents of benefit to 2025 that should not repeat in 2026.

Speaker #2: Further, the company recognized approximately $4 million or 4 cents of employee retention credit benefits occurring in Q2 of 2025, also not likely to repeat.

Speaker #2: Therefore, the appropriate adjusted EPS comparison should be $5.75. Now turning to expectations for 2026 fiscal year, while we expect several product approvals this year, given the timing of commercial launches as amended discussed, we don't anticipate meaningful revenue contribution this year.

Bob Marshall: Taken together, the comparable baseline would be $1,424.2 million. The EPS impact on these adjustments equates to approximately $0.16. Operating expenses also require normalization adjustments for comparison's sake as well. During 2025, the company reduced accrued bonus expense, resulting in approximately $0.14 of benefit to 2025. That should not repeat in 2026. The company recognized approximately $4 million or $0.04 of employee retention credit benefits occurring in Q2 2025, also not likely to repeat. The appropriate adjusted EPS comparison should be $5.75. Now turning to expectations for 2026 fiscal year. While we expect several product approvals this year, given the timing of commercial launches, as Amanda discussed, we don't anticipate meaningful revenue contribution this year.

Speaker #2: Our focus in 2026 will be the continued commercial execution assuring a successful transition for our new PSMA pet formulation setting the stage for revenue and earnings growth acceleration exiting 2026.

Speaker #2: Now for the details, the forecast for clarified considers the annualization of pricing decisions made in 2025 and related impacts as well as the potential for renewed competitive dynamics as the year progresses.

Speaker #2: Notably, as the only one other commercially available F-18 agent nears the end of its traditional pass-through period as of September 30th. Therefore, we see clarified net revenue declining 8 to 10 percent year over year consisting of increased volume offset by modest price erosion.

Bob Marshall: Our focus in 2026 will be the continued commercial execution, assuring a successful transition for our new PSMA PET formulation, setting the stage for revenue and earnings growth acceleration exiting 2026. Now for the details. The forecast for PYLARIFY considers the annualization of pricing decisions made in 2025 and related impacts, as well as the potential for renewed competitive dynamics as the year progresses. Notably, as the only one other commercially available F-18 agent nears the end of his traditional pass-through period as of 30 September. Therefore, we see PYLARIFY net revenue declining 8% to 10% year-over-year, consisting of increased volume, offset by modest price erosion. To assist with modeling, each quarter should be fairly similar sequentially from a net revenue perspective, with volumes and discounts growing throughout the year.

Speaker #2: To assist with modeling, each quarter should be fairly similar sequentially from a net revenue perspective. With volumes and discounts growing throughout the year. This includes the fourth quarter during which we will undertake the transition of our PMF channel partners from Polarify to our new formulation on a rolling geographic basis.

Speaker #2: We see neurosy growing triple digits. Inorganically, and Definity is expected to grow low to mid-single digits. Taken together, we forecast worldwide net revenue of $1.4 to $1.45 billion for 2026.

Speaker #2: Moving down the P&L, gross margin continues to model at approximately 65.5%. While we have the opportunity to leverage our established infrastructure and common targeted customer base, we will continue to invest in sales and marketing in support of our new PSMA PET formulation, as well as Octavi, to ensure broad availability and access.

Bob Marshall: This includes the Q4, during which we will undertake the transition of our PMF channel partners from PYLARIFY to our new formulation on a rolling geographic basis. We see Neuraceq growing triple digits inorganically, and DEFINITY is expected to grow low to mid-single digits. Taken together, we forecast worldwide net revenue of $1.4 to $1.45 billion for 2026. Moving down the P&L, gross margin continues to model at approximately 65.5%. While we have the opportunity to leverage our established infrastructure and common targeted customer base, we will continue to invest in sales and marketing in support of our new PSMA PET formulation, as well as activity to ensure broad availability and access.

Speaker #2: R&D is expected to move to 10 to 11 percent of revenue, an increase of approximately 200 basis points, across a number of phase-gated projects anchored by our GRPR diagnostic agent.

Speaker #2: G&A should be essentially flat with 2025 at 10% of net revenue. Our net interest expense and other is expected to change in 2026 to $5 million of expense from approximately $9 million $4 million of net income in 2025.

Speaker #2: This $9 million headwind is due largely to lost interest income on funds we used on our 2025 M&A activity as well as to share repurchases executed throughout 2025.

Speaker #2: The effective tax rate is expected to increase slightly by about a point to 26%, fully diluted shares outstanding should average 66 million shares for the year.

Bob Marshall: R&D is expected to move to 10 to 11% of revenue, an increase of approximately 200 basis points across a number of phase-gated projects, anchored by our GRPR diagnostic agent. G&A should be essentially flat with 2025 at 10% of net revenue. Our net interest expense and other is expected to change in 2026 to $5 million of expense from approximately $9 million, $4 million of net income in 2025. This $9 million dollar headwind is due largely to lost interest income on funds we used on our 2025 M&A activity, as well as through share repurchases executed throughout 2025. The effective tax rate is expected to increase slightly by about 1 point to 26%. Fully diluted shares outstanding should average 66 million shares for the year.

Speaker #2: Altogether, we forecast EPS in a range of $5 to $5.25. As Marianne noted, following last year's considerable M&A activity, we are undertaking a full review of our pipeline portfolio and expense base.

Speaker #2: We are committed to focusing on investment and related commercial efforts largely on our diagnostic portfolio. For the therapeutic assets in our pipeline, we are contemplating alternative opportunities to advance these assets and optimize their value for the company and our shareholders.

Speaker #2: This process will take the better part of 2026 during which we are confident that there will be further opportunities to rebase the company's earnings profile and growth trajectory with annualized synergies achieved in addition to the avoidance of higher costs of late-stage R&D development often associated with therapeutic product candidates.

Bob Marshall: Altogether, we forecast EPS in a range of $5 to $5.25. As Mary Anne noted, following last year's considerable M&A activity, we are undertaking a full review of our pipeline portfolio and expense base. We are committed to focusing on investment in related commercial efforts, largely on our diagnostic portfolio. For the therapeutic assets in our pipeline, we are contemplating alternative opportunities to advance these assets and optimize their value for the company and our shareholders. This process will take the better part of 2026, during which we are confident that there will be further opportunities to rebase the company's earnings profile and growth trajectory with annualized synergies achieved, in addition to the avoidance of higher costs of late-stage R&D development often associated with therapeutic product candidates.

Speaker #2: We believe that the therapeutic pipeline has material value and this plan is intended to unlock that value for shareholders which is not reflected in our stock price or our guidance.

Speaker #2: With that, let me turn the call back over to Marianne.

Speaker #3: Thank you, Bob. What we focused in 2025 on the competitive diagnostics experience in the PSMA pet imaging market and our work to successfully integrate acquisitions we are now taking purposeful steps to sharpen our focus on our strategic priorities especially in the diagnostic space and leverage both our capabilities and portfolio in 2026 and beyond.

Speaker #3: Allow me to again state our priorities for 2026. Maintain our market leadership in PSMA pet by sustaining Polarify volume growth. Execute a seamless transition to the new PSMA pet formulation beginning in the fourth quarter.

Bob Marshall: We believe that the therapeutic pipeline has material value. This plan is intended to unlock that value for shareholders, which is not reflected in our stock price or our guidance. With that, let me turn the call back over to Mary Ann.

Speaker #3: Increase momentum for neurosy by expanding our manufacturing footprint and driving deeper penetration in existing accounts and accounts where a strong Polarify relationship already exists.

Mary Anne Heino: Thank you, Bob. While we focused in 2025 on the competitive dynamics experienced in the PSMA PET imaging market and our work to successfully integrate acquisitions, we are now taking purposeful steps to sharpen our focus on our strategic priorities, especially in the diagnostic space, and leverage both our capabilities and portfolio in 2026 and beyond. Allow me to again state our priorities for 2026. Maintain our market leadership in PSMA PET by sustaining PYLARIFY volume growth. Execute a seamless transition to the new PSMA PET formulation beginning in Q4. Increase momentum for Neuraceq by expanding our manufacturing footprint and driving deeper penetration in existing accounts and accounts where a strong PYLARIFY relationship already exists. Advance our assets currently under FDA review through regulatory approval milestones and effect fit-for-purpose launch activities with those assets that offer the earliest and best revenue return....

Speaker #3: Advance our assets currently under FDA review through regulatory approval milestones and effect fit-for-purpose launch activities with those assets that offer the earliest and best revenue return.

Speaker #3: Selectively develop other pipeline assets towards key stage gates and decision points and allocate capital with discipline. Prioritizing radio diagnostics seeking to optimize the value of our radiotherapeutic pipeline and maintaining financial flexibility while committing to a leveraged P&L that delivers value to our shareholders.

Speaker #3: We enter 2026 with confidence in our strategy and our ability to deliver. Recognizing this represents a year of intentional investment and portfolio prioritization that will position the company for solid financial performance and durable value creation.

Speaker #3: As we do so, we remain focused on the patients we serve having helped impact the lives of approximately 7 million patients in 2025. I want to thank our shareholders, employees, and our loyal customers for their continued support and dedication.

Mary Anne Heino: selectively develop other pipeline assets towards key stage gates and decision points, and allocate capital with discipline, prioritizing radiodiagnostics, seeking to optimize the value of our radiotherapeutic pipeline, and maintaining financial flexibility while committing to a leveraged P&L that delivers value to our shareholders. We enter 2026 with confidence in our strategy and our ability to deliver, recognizing this represents a year of intentional investment and portfolio prioritization that will position the company for solid financial performance and durable value creation. As we do so, we remain focused on the patients we serve, having helped impact the lives of approximately 7 million patients in 2025. I want to thank our shareholders, employees, and our loyal customers for their continued support and dedication. With that, I'll turn it over to Q&A. Operator?

Speaker #3: With that, I'll turn it over to Q&A. Operator?

Speaker #4: Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

Speaker #4: Please limit yourself to one question per person. One moment for questions. Our first question comes from Anthony Petrone with Mizuho Cap Financial Group. You may proceed.

Speaker #5: Thank you. And hi, Marianne. Welcome back. Hope you're doing well. Hi, Bob, Amanda, Mark. Hope everyone's doing well. Maybe I'll start off with two quick ones just know a lot of folks are on the line here.

Speaker #5: But start with just the March 6th PDUFA date for next-gen PSMA pet imaging agent. Thanks for the updates there. On a fourth-quarter rollout. But when we think about taking a glass half-full approach assuming the PDUFA date goes as expected and we get clearance what will be the timing when we do secure coding when we get realization on when what the TPT sort of reimbursement rate will be?

Operator: Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please limit yourself to one question per person. One moment for questions. Our first question comes from Anthony Petrone with Mizuho Financial Group. You may proceed.

Anthony Petrone (Mizuho Securi: Thank you. Hi, Mary Anne, welcome back. I hope you're doing well. Hi, Bob, Amanda, Mark, hope everyone's doing well. Maybe I'll start off with 2 quick ones. Just know a lot of folks are on the line here. Start with, you know, just the March 6th PDUFA date for next gen PSMA PET imaging agent. Thanks for the updates there on a Q4 rollout. When we think about taking a glass half full approach, assuming, you know, the PDUFA date goes as expected and we get clearance, you know, what will be the timing when we do secure coding, you know, when we get realization on what the TPT sort of reimbursement rate will be?

Anthony Petrone: Thank you. Hi, Mary Anne, welcome back. I hope you're doing well. Hi, Bob, Amanda, Mark, hope everyone's doing well. Maybe I'll start off with 2 quick ones. Just know a lot of folks are on the line here. Start with, you know, just the March 6th PDUFA date for next gen PSMA PET imaging agent. Thanks for the updates there on a Q4 rollout. When we think about taking a glass half full approach, assuming, you know, the PDUFA date goes as expected and we get clearance, you know, what will be the timing when we do secure coding, you know, when we get realization on what the TPT sort of reimbursement rate will be? Maybe a little bit of detail on how you will begin that transition, specifically with long-term contracts that are out there, and I'll have one quick follow-up. Thanks.

Speaker #5: And maybe a little bit of detail on how you will begin that transition specifically with long-term contracts that are out there and I'll have one quick follow-up.

Speaker #5: Thanks.

Speaker #3: Anthony, I'll take that. And thank you so much. It is, as I said, great to be back in my operational role here. And as you noted, it is absolutely a glass wonderfully half-full about our new PSMA pet formulation.

Speaker #3: Let me review some of the dates we're assuming here, and that will also then, I think, explain our strategy as we move forward. As you noted, our PDUFA date is March 6th.

Speaker #3: The two items that Amanda well, two of the items that Amanda referenced that are important with a launch of any pet-based product is you need to ensure that you have secured a HIC-6 code as well as transitional pass-through status.

Anthony Petrone (Mizuho Securi: Maybe a little bit of detail on how you will begin that transition, specifically with long-term contracts that are out there, and I'll have one quick follow-up. Thanks.

Speaker #3: And those are two separate activities. We would anticipate that we would have in place by October 1st our HIC-6 code and that for having submitted our transitional pass-through application by June 1st that that will also be in place by October 1st.

Mary Anne Heino: Anthony, I'll take that, and thank you so much. It is, as I said, great to be back in my operational role here. As you noted, it is absolutely a glass wonderfully half full about our new PSMA PET formulation. Let me review some of the dates we're assuming here. That will also then, I think, explain our strategy as we move forward. As you noted, our PDUFA date is 6 March. Well, two of the items that Amanda referenced that are important with the launch of any PET-based product, is you need to ensure that you have secured a HCPCS code as well as transitional pass-through status. Those are two separate activities.

Speaker #3: And it's very important that those events precede your commercial entry into the market. That is why you hear us referring to late 2026 or specifically the fourth quarter for the operational rollout of the PMS.

Speaker #3: And as you can remember from our Polarify launch and from the other launches of F-18-based assets into this category you have to stand up or get approved each PMS separately because they each represent a GMP-approved manufacturing site.

Mary Anne Heino: We would anticipate that we would have in place by 1 October, our HCPCS code, and that for having submitted our Transitional Pass-Through application by 1 June, that that will also be in place by 1 October. It's very important that those events precede your commercial entry into the market. That is why you hear us referring to late 2026, or specifically the Q4, for the operational rollout of the PMS. As you can remember from our PYLARIFY launch and from the other launches of F-18-based assets into this category, you have to stand up or get approved each PMS separately because they each represent a GMP-approved manufacturing site. Our goal is to make sure that we never have disruption of product Lantheus product availability in that market.

Speaker #3: Our goal is to make sure that we never have disruption of product availability in that market. So we've chosen a regional rollout allowing for duplicities so that we absolutely still have service in place to flip from Polarify to our new formulation which we will offer a name and start using as soon as it's approved.

Speaker #3: And we anticipate for making sure that that is the risk that that will take us the fourth quarter to accomplish. So coming out of the fourth quarter we will have a network as broad as we have in place currently for Polarify in place for our new formulation.

Speaker #3: And that is why we keep referencing to say that significant revenue-related to that product will really occur in 20 beginning in 2027 and not as much in 2026.

Speaker #3: But we feel like we've got all bases covered here. We're all waiting for the March 6th date. It is right in front of us now.

Mary Anne Heino: We've chosen a regional-based rollout, allowing for duplicity so that we absolutely still have service in place to flip from PYLARIFY to our new formulation, which we will offer a name and start using as soon as it's approved. We anticipate for making sure that that is the risk, that that will take us Q4 to accomplish. Coming out of Q4, we will have a network as broad as we have in place currently for PYLARIFY, in place for our new formulation. That is why we keep referencing to say that significant revenue related to that product will really occur beginning in 2027 and not as much in 2026. We feel like we've got all bases covered here. We're all, you know, waiting for the 6 March date.

Speaker #3: And you can certainly imagine that there will be a press release around that date to communicate what we've heard from the FDA.

Speaker #5: Excellent. And just a quick one is just the market dynamics for Polarify as is today down 8 to 10 percent. We know that there's a study out there post-Luma versus Polarify a head-to-head study.

Speaker #5: I believe it reads out at ASCO. And so maybe what is baked into the negative 8 to 10 percent for share shift? How does the outcome of this study play into that?

Speaker #5: Thanks again. Welcome back.

Speaker #3: Oh, thanks, Anthony. And kind of interesting to talk about that study because I will be honest and say we do absolutely have some concerns regarding the study design that was used first and foremost.

Mary Anne Heino: It is right in front of us now, and you can certainly imagine that there will be a press release, around that date, to communicate what we've heard from the FDA.

Speaker #3: There's no randomization in the study. If you read the protocol and you see how it was executed the Polarify images were always captured first.

Anthony Petrone (Mizuho Securi: excellent. Just a quick one is just the market dynamics for PYLARIFY, as is today, down 8% to 10%. We know that there's a study out there, POSLUMA versus PYLARIFY, a head-to-head study. I believe it reads out at ASCO. Maybe what is baked into the negative 8% to 10% per share shift? How does the outcome of the study play into that? Thanks again. Welcome back.

Anthony Petrone: excellent. Just a quick one is just the market dynamics for PYLARIFY, as is today, down 8% to 10%. We know that there's a study out there, POSLUMA versus PYLARIFY, a head-to-head study. I believe it reads out at ASCO. Maybe what is baked into the negative 8% to 10% per share shift? How does the outcome of the study play into that? Thanks again. Welcome back.

Speaker #3: And in a fully randomized trial you'd probably expect to see something different. Also as concerning there's no truth standard. If you look at the design of the study there really measuring just SUV and detection rate.

Speaker #3: And kind of the odd thing of that is when you measure detection rate that way you actually give yourself credit for false positives. So the high detection rate may be due to the false positives that are already noted in that product package insert.

Mary Anne Heino: Thanks, Anthony. Kind of interesting to talk about that study, because I will, I will be honest and say we do absolutely have some concerns regarding the study design that was used. First and foremost, there's no randomization in the study. If you read the protocol and you see how it was executed, the PYLARIFY images were always captured first, and in a fully randomized trial, you'd probably expect to see something different. Also, it's concerning there's no truth standard. If you look at the design of the study, they're really measuring just SUV and detection rate. The kind of the odd thing of that is, when you measure detection rate that way, you actually give yourself credit for false positives. The high detection rate may be due to the false positives that are already noted in that product package insert.

Speaker #3: Also if it's just from a math perspective the study was not powered. To show statistical significance. And from a clinical perspective there's really two relevant comments here.

Speaker #3: First, bladder SUV values do not impact diagnostic performance. And that is what the study is really measuring. Second, and very much not in line with current clinical practice.

Speaker #3: The men in the study because of course it was all male patients were not allowed. They were actually prevented from voiding prior to having their scan done.

Speaker #3: And that is very much the opposite of what happens in clinical practice today. So I will say we are glad to see continued scientific investigation into this incredibly important class.

Mary Anne Heino: If it's just from a math perspective, the study was not powered to show statistical significance. From a clinical perspective, there's really two relevant comments here. First, bladder SUV values do not impact diagnostic performance, and that is what the study is really measuring. Second, and very much not in line with current clinical practice, the men in the, in the study, because of course it was all male patients, were not allowed, they were actually prevented from voiding prior to having their scan done. That is very much the opposite of what happens in clinical practice today. I will say we are glad to see continued scientific investigation into this incredibly important class, but we also would very much hope that it would be rigorous scientific evaluation. I will share with you, because you referenced: How did that bake into our forecast?

Speaker #3: But we also would very much hope that it would be rigorous scientific evaluation. And I will share with you because you referenced how did that bake into our forecast the results of that study really do not bake into our forecast.

Speaker #5: Thank you. Our next question comes from Richard Newetter with Truist. You may proceed.

Speaker #6: Hi. Thanks for taking the questions. So I just wanted to put a finer point on what your kind of pricing and unit growth played out how that played out in 4Q25.

Speaker #6: You were at 3% unit growth. I think you said in the third quarter you had about a 500 basis point 340B-driven price headwind to contend with.

Speaker #6: In the fourth quarter I'm getting to a high single digit unit growth rate in 4Q. And is that right? And then what was behind that?

Mary Anne Heino: The results of that study really do not bake into our forecast.

Operator: Thank you. Our next question comes from Richard Newcomer with Truist. You may proceed.

Speaker #6: Did the market improve? Did you just call back some share if that is in fact right? And then maybe Bob, can you give us a little more on what the market assumptions are for 2026 for Polarify and kind of what your unit and price assumptions kind of are within that?

Richard Newth: Hi, thanks for taking the questions. So I just wanted to put a finer point on what your kind of pricing and unit growth played out, how that played out in Q4 2025. You were at 3% unit growth, I think you said. In Q3, you had about a 500 basis point, 340B driven price headwind to contend with in Q4. I'm getting to, like, a high single digit unit growth rate in Q4, and is that right? You know, what was behind that? Did the market improve? Did you just call back some share, if that is in fact right?

Richard Newitter: Hi, thanks for taking the questions. So I just wanted to put a finer point on what your kind of pricing and unit growth played out, how that played out in Q4 2025. You were at 3% unit growth, I think you said. In Q3, you had about a 500 basis point, 340B driven price headwind to contend with in Q4. I'm getting to, like, a high single digit unit growth rate in Q4, and is that right? You know, what was behind that? Did the market improve? Did you just call back some share, if that is in fact right? Maybe, Bob, can you give us a little more on what the market assumptions are for 2026 for PYLARIFY and kind of what your unit and price assumptions kinda are within that? Thank you.

Speaker #6: Thank you. Yeah. So Rich, I'll take that. In terms of growth I mean, listen, it was a great quarter from a Polarify perspective. Obviously, above our expectations.

Speaker #6: But it was both volume and in a little bit of benefit actually coming from the gross to net price change. And I think when we talked about it during kind of the fourth quarter following our call and whatnot we had sort of pegged it at sort of a mid-teens and that's effectively what we saw.

Richard Newth: Maybe, Bob, can you give us a little more on what the market assumptions are for 2026 for PYLARIFY and kind of what your unit and price assumptions kinda are within that? Thank you.

Speaker #6: And that was maybe slightly more favorable than the actual teens growth that we were kind of thinking. So I think Amanda pointed out I think it was like 4% volume growth.

Speaker #6: And it did turn out to be our single greatest sort of volume performance in the quarter. I mean, excuse me, for the full year.

Bob Marshall: Yeah. Rich, I'll take that. In terms of growth, I mean, listen, it was a great quarter from a PYLARIFY perspective, obviously above our expectations. It was both volume and a little bit of benefit actually coming from the gross to net price change. You know, I think when we talked about it during kind of the Q4, you know, following our call and whatnot, we had sort of pegged it at sort of the mid-teens, and that's effectively what we saw. That was maybe slightly more favorable than the actual teens growth that we were kind of thinking.

Speaker #6: When I think about assumptions going into how we're playing out 2026 so we are thinking sort of a similar sort of low single digit volume growth for the year.

Speaker #6: Much not too dissimilar from 2025. And from a pricing perspective, what we've done is that while we've seen a lot of consistency in the market from a pricing perspective over the last couple of quarters, as we think about one of those competitors losing pass-through, they may actually look to try to use pricing as a mechanism to drive share.

Bob Marshall: You know, as I think Amanda pointed out, I think it was like 4% volume growth, and it did turn out to be our single greatest sort of volume performance in the quarter. I mean, excuse me, for the full year. When I think about assumptions going into how we're playing out 2026, we are thinking sort of a similar sort of low single-digit volume growth for the year, much not too dissimilar from 2025. From a pricing perspective, what we've done is that while we've seen a lot of consistency in the market from a pricing perspective over the last couple of quarters, you know, as we think about one of those competitors losing passthrough, that they may actually look to try to use pricing as a mechanism to drive share.

Speaker #6: Now we've been really pretty disciplined and we've been really explicit that as we think about executing our strategy that we're going to stay disciplined.

Speaker #6: We're not going to chase business that is not good for the medium to long-term value of that franchise. So the guide assumes that we see sort of a continuation of some incremental price that would sort of move us from sort of the mid-teens of where we are now to maybe the high teens as we progress through the year.

Speaker #6: From a gross to net adjustment perspective. And that's why you see sort of what I've laid out as sort of a sequential net revenue sort of neutral outcome for each of the quarters throughout 2026.

Bob Marshall: We've been really pretty disciplined, and we've been really explicit that as we think about executing our strategy, that we're gonna stay disciplined. We're not gonna chase business that is not good for the medium to long-term value of that franchise. The guide assumes that we see sort of a continuation of some, you know, incremental price that would sort of move us from sort of the mid-teens of where we are now to, you know, maybe the high teens as we progress through the year from a gross to net adjustment perspective. That's why you see sort of what I've laid out as sort of a sequentially net revenue, sort of neutral outcome for each of the quarters throughout 2026.

Speaker #3: So Rich, this is Marion. Does that answer your question?

Speaker #6: Yeah, it does. So it sounds like you're not seeing any dramatic changes to the pricing environment currently to be prudent. Because this is what took you by surprise and all of us by surprise last year.

Speaker #6: You're embedding that assumption that there will be another kind of regular way price erosion situation or you'll have to walk away from that business incrementally.

Speaker #6: And that's a placeholder in your guide. And you don't really assume any contribution from 2.0. So there should be there could be upside if those things don't play out that way.

Speaker #6: And you start to get some benefit from 2.0 if all goes well next week. And you can execute on the transition faster. Is that a fair way to look at these numbers?

Mary Anne Heino: Rich, this is Marian. Does that answer your question?

Richard Newth: Yeah, it does. It sounds like you're not seeing any dramatic changes to the pricing environment currently. To be prudent, you're because this is what took you by surprise and all of us by surprise last year, you're embedding that assumption that there will be another kind of regular way price erosion situation, or you'll have to walk away from that business incrementally. That's a placeholder in your guide, and you don't really assume any contribution from 2.0. There should be, there could be upside if those things don't play out that way, and you start to get some benefit from 2.0, if all goes well next week, and you can execute on the transition faster. Is that a fair way to look at these numbers?

Richard Newitter: Yeah, it does. It sounds like you're not seeing any dramatic changes to the pricing environment currently. To be prudent, you're because this is what took you by surprise and all of us by surprise last year, you're embedding that assumption that there will be another kind of regular way price erosion situation, or you'll have to walk away from that business incrementally. That's a placeholder in your guide, and you don't really assume any contribution from 2.0. There should be, there could be upside if those things don't play out that way, and you start to get some benefit from 2.0, if all goes well next week, and you can execute on the transition faster. Is that a fair way to look at these numbers?

Speaker #3: Yep. Rich, absolutely. And I have to say it's such a great pleasure to have analysts like yourself monitoring our business where you know the market so well and also understand our strategy.

Speaker #3: But you are really spot on with how we're thinking about the market.

Speaker #6: Okay. Thank you, guys.

Speaker #5: Thank you. Our next question comes from Ryan Ruiz with Learning Partners. You may proceed.

Speaker #7: Hey, morning everyone. So I was curious, could you elaborate a bit more on one of your comments about pursuing value-maximizing alternatives for radiotherapeutic assets to support long-term growth?

Speaker #7: It made me think about are you thinking about different features of products? Are you looking for could this be part of near-term BD? I know you mentioned the comments possible tuck-ins this year.

Mary Anne Heino: Yep. Rich, absolutely, I have to say, it's such a great pleasure to have analysts like yourself monitoring our business where you know the market so well and also understand our strategy. You are really spot on with how we're thinking about the market.

Speaker #7: So I was just curious if you could explain a bit more there.

Speaker #3: Absolutely. And I'm glad that everyone is kind of picking up on the comments that both Bob and I made about this intentional focusing of our strategy.

Richard Newth: Okay. Thank you, guys.

Richard Newitter: Okay. Thank you, guys.

Operator: Thank you. Our next question comes from Roanna Ruiz with Leerink Partners. You may proceed.

Speaker #3: We really see it as the natural outcome of all the activity that we had in '25 and even '24. We have now a very broad portfolio of both diagnostic and therapeutic assets.

Roanna Ruiz: Hey, morning, everyone. Was curious, could you elaborate a bit more on one of your comments about pursuing value-maximizing alternatives for radiotherapeutic assets to support long-term growth? It made me think about, are you thinking about different features of products that you're looking for? Could this be part of near-term BD? I know you mentioned on the comments, possible tuck-ins this year, so I was just curious if you could explain a bit more there.

Speaker #3: And our intent is to and we think our obligation to our shareholders is to make sure that the value of each of those is considered.

Speaker #3: But we certainly could not handle or accomplish the advancement of that entire portfolio. So we've chosen to focus in on the diagnostic assets. And as you'll see, I had a pipeline slide in the middle of my presentation and it will also show it again at the end.

Mary Anne Heino: Absolutely. I'm glad that everyone is kind of picking up on the comments that both Bob and I made about this intentional focusing of our strategy. We really see it as the natural outcome of all the activity that we had in 2025 and even 2024. We have now a very broad portfolio of both diagnostic and therapeutic assets, and our intent is to, and we think our obligation to our shareholders, is to make sure that the value of each of those is considered. We certainly could not handle or accomplish the advancement of that entire portfolio. We've chosen to focus in on the diagnostic asset. As you'll see, I had a pipeline slide in the middle of my presentation, and we'll also show it again at the end.

Speaker #3: It really is a very broad portfolio there. When we refer to the therapeutic assets, what we're referring to is and we have undertaken a full review of our whole portfolio.

Speaker #3: But looking really at what are the stage gates for the therapeutic assets that really define value for them so that as we consider how they should be then driven further and it will be through external alternatives or partnered alternatives, how is it best for us to present the value and the clinical utility of these products?

Speaker #3: And so a lot more to come a lot more to come on that as we talk throughout the year. I will mention and it really comes back to what you mentioned with tuck-ins further tuck-ins for diagnostic opportunities.

Mary Anne Heino: It really is a very broad portfolio there. When we refer to the therapeutic assets, what we're referring to is, and we have undertaken a full review of our whole portfolio, but looking really at what are the stage gates for the therapeutic assets that really define value for them. As we consider how they should be then driven further, and it will be through external or alternatives or partnered alternatives, how is it best for us to present the value, and the clinical utility of these products? A lot more to come, a lot more to come on that as we talk throughout the year. I will mention, and it really comes back to what you mentioned with tuck-ins, further tuck-ins for diagnostic opportunities.

Speaker #3: If we find them and they fit, then yes, absolutely we'll consider them. But even as we talk about the therapeutic assets, I probably should be clear to say that when I talk about that, I'm not talking about P&T 2003.

Speaker #3: That product is right before us as far as regulatory approval opportunity. It's a natural fit into our portfolio of products. And again, our customer base so we are already committed to what we believe will be a very successful launch of that product.

Speaker #5: Thank you. Our next question comes from Matt Taylor with Jefferies. You may proceed.

Speaker #8: Hi, good morning. Thanks for taking the question. I guess I'll ask one on neurosec. It came in nicely in Q4. And your guidance, you said, was I think at least triple-digit growth.

Mary Anne Heino: If we find them and they fit, then yes, absolutely, we'll consider them. Even as we talk about the therapeutic assets, I probably should be clear to say that when I talk about that, I'm not talking about PNT2003. That product is right before us as far as regulatory approval opportunity. It's a natural fit into our portfolio of products and again, our customer base. We are already committed to what we believe will be a very successful launch of that product.

Speaker #8: I guess now that that's a bad growth rate, but why couldn't it actually be higher than that given the momentum that you have and also the sequential growth that we're seeing in some of these Alzheimer therapeutics?

Speaker #3: Oh, man. We absolutely do see a triple-digit pretty good here, Matt. And I think what you were also hearing from us again we inherited that product as a we'll call it mid-year last year.

Operator: Thank you. Our next question comes from Matt Taylor with Jefferies. You may proceed.

Speaker #3: And one of the things and again, this comes back to FAP-based products in this market. You have to have the manufacturing footprint to be able to bring your product broadly to patients.

Matt Taylor: Hi, good morning. Thanks for taking the question. I guess I'll ask one on Neuraceq. It came in nicely in Q4, and your guidance, you said, it was, I think, at least triple-digit growth. You know, I guess, not that that's a bad growth rate, but why couldn't it actually be higher than that, given the momentum that you have and also the sequential growth that we're seeing in some of these Alzheimer therapeutics?

Speaker #3: And I will say I think the numbers have been discussed before. But the number of standing PMS for neurosec at the time you acquired it was call it mid-20s we added a few added a few and someone might correct me if I'm wrong there.

Mary Anne Heino: Oh, Matt. We absolutely do see a, triple-digit, pretty good here, Matt. I think what you are also hearing from us, again, we inherited that product as of, we'll call it mid-year last year. One of the things, again, this comes back to F-18-based products in this market, you have to have the manufacturing footprint to be able to bring your product broadly to patients. I will say, I think the numbers have been discussed before, but the number of standing PMS for Neuraceq at the time we acquired it, was, call it, mid-20s. We added a few, and someone might correct me if I'm wrong there, but we added a few. Our intent is to add 6 more this coming year.

Speaker #3: But we added a few. And then our intent is to add six more this coming year. Therefore, we will start to approach having what we consider a broad geographic footprint for that product.

Speaker #3: And I'm sorry, I've been corrected. The starting number of PMS when we inherited the product was 16. And again, we will continue to add that really is the way that we measure how far we can take the product into new areas.

Speaker #3: And then the other part of our what we think is a very promising forecast is our ability to take the product deeper into the accounts where it already is based on some changes in guidelines and the broadening that we saw in the PIs last year as well as by also leveraging the relationships that we have in accounts with other Lantheus products.

Speaker #3: So again, happy to be wrong here and have it even further exceed what we have. But I think we've been very practical, optimistic, but practical with our forecast.

Mary Anne Heino: Therefore, we will start to approach having what we consider a broad geographic footprint for that product. I'm sorry, I've been corrected. The starting number of PMS when we inherited the product was 16. Again, we will continue to add. That really is the way that we measure how far we can take the product into new areas. The other part of our, what we think is a very promising forecast, is our ability to take the product deeper into the accounts where it already is based on some changes in guidelines and the broadening that we saw in the PIs last year, as well as by also leveraging the relationships that we have in accounts with other Lantheus products.

Speaker #3: And Bob, do you want to add something there?

Speaker #6: I do. Because I just I mean, while people can figure this out from a mathematical situation, by triple digits, we're talking something in call it the 140 to 150 percent range of inorganic growth off of what was a very good fourth quarter, which was the first full quarter that we actually had the asset in the portfolio commercially.

Speaker #5: Thank you.

Speaker #3: Does that answer your question?

Speaker #5: Our next question comes from Paul Choi with Goldman Sachs. You may proceed.

Mary Anne Heino: Again, happy to be wrong here and have it even further exceed what we have, but I think we've been very practical, optimistic, but practical with our forecast. Bob, do you want to add something, Matt?

Speaker #9: Hi, thank you for taking our question. This is Karishma on for Paul. If the upcoming BIB data does show meaningful tau reduction but no benefit on cognitive measures, how does this affect your go-forward investment in your tau program?

Bob Marshall: I do, Well, people can figure this out from a mathematical situation. By triple digits, we're talking certainly in, like, call it the 140 to 150% range of inorganic growth off of what was a very good Q4, which was the first full quarter that we actually had the asset in the portfolio commercially.

Speaker #9: Thank you so much.

Speaker #3: I'm sorry. Can you repeat what you're referring to?

Speaker #9: No. The study.

Speaker #3: Can you repeat the first part of your question, please?

Speaker #9: Yeah. Sorry. If the upcoming biogen data shows meaningful TAU reduction but no benefit on cognitive measures, how does this affect your go-forward investment in your TAU program?

Matt Taylor: Thank you.

Mary Anne Heino: Did that answer your question, Matt?

Speaker #9: Thank you.

Speaker #3: Okay. I'm sorry. We just didn't hear the first part of your question. But it makes perfect sense. We will, of course, or very eagerly awaiting those data.

Operator: Our next question comes from Paul Choi with Goldman Sachs. You may proceed.

Karishma Raghuram: Hi, thank you for taking our question. This is Karishma on for Paul. If the upcoming bib data does show meaningful tau reduction, but no benefit on cognitive measures, how does this affect your go-forward investment in your tau program? Thank you so much.

Speaker #3: But I think there's very, very strong scientific evidence already that the presence of TAU and the quantification of TAU is aligned with cognitive performance of patients.

Speaker #3: And that really is something that's slightly different than the role that amyloid plays. Amyloid and to think about it, I guess bluntly, amyloid comes early.

Mary Anne Heino: I'm sorry, could you repeat what you're referring to? No, this time. Can you repeat the first part of your question, please?

Speaker #3: But it doesn't always match to cognitive change in patients where there is a much stronger correlation between rise of TAU, especially in certain areas of the brain, and unfortunately, related cognitive defects for patients.

Karishma Raghuram: Yeah, sorry. If the upcoming Biogen data shows meaningful tau reduction, but no benefit-

Mary Anne Heino: Oh, yes.

Karishma Raghuram: on cognitive measures, how does this affect your go-forward investment in your tau program? Thank you.

Mary Anne Heino: Okay. I'm sorry, We just didn't hear the first part of your question, but it makes perfect sense. We will, of course, are very eagerly awaiting those data, but I think there's very, very strong scientific evidence already that the presence of tau and the quantification of tau is aligned with cognitive performance of patients. That really is something that's slightly different than the role that amyloid plays. Amyloid, you know, to think about it. I guess one, the amyloid comes early, but it doesn't always match to cognitive change in patients, where there is a much stronger correlation between rise of tau, especially in certain areas of the brain, and unfortunately related cognitive defects for patients.

Speaker #3: So I think what we're seeing in this market and we're kind of all seeing it in real time because that's a wonderful thing that's happening around us.

Speaker #3: There really is is willing and acting on taking these products for that are disease-modifying and starting to use them in patients. And the kind of complementary use increased and increased use of imaging both amyloid and TAU will come along with that.

Speaker #3: But I won't speculate on data that are not out yet. Other than to say we are from a scientific perspective, we are fairly confident in the role of TAU in the market.

Speaker #3: As you heard Amanda mention, our biomarker business, TAU is the our product, MK6240, is the number one product that's used in what we see as the 17 underlying the ongoing studies in the market.

Mary Anne Heino: I think what we're seeing in this market, and we're kind of all seeing it in real time because that's a wonderful thing that's happening around us. There really is now, a market that is willing and acting on taking these products for, that are disease-modifying and starting to use them in patients. The kind of complementary use, increased use of imaging, both amyloid and tau, will come along with that. I won't, I won't speculate on data that are not out yet, other than to say we are, from a scientific perspective, we are fairly confident in the role of tau in the market.

Speaker #5: Thank you. Our next question comes from Larry Zolo with CGS Securities. You may proceed.

Speaker #10: Great. Thank you. And I echo the welcome back, Marianne. It sounds like the CEO search is progressing though. So is this going to be like a you feel like the six-month, 12-month type of thing?

Mary Anne Heino: As you heard, Amanda mention, in our biomarker business, tau is our product, MK-6240, is the number one product that's used in what we see as the 17 underlying, the ongoing studies in the market.

Speaker #10: Any thoughts on just timing?

Speaker #3: So it is progressing, Larry. And it's good to be talking with you again. I want to say two things that I think are in our favor.

Speaker #3: I think this is an incredible opportunity for someone to step into what the future of our company and where we're going to be taking this company.

Operator: Thank you. Our next question comes from Larry Solow with CJS Securities. You may proceed.

Speaker #3: And so I think as exciting as that is to me, I think it's also something that is exciting to the candidates we're talking to.

Larry Solow: Great, thank you, and I echo the welcome back, Marianne. It sounds like the CEO search is progressing though, so, you know, is this gonna be like a, do you feel like it's a six-month, 12-month type of thing? Any, any thoughts on just timing?

Speaker #3: And the other thing I will say is as everyone knows, we sit fairly adjacent to what is an incredibly active market in the United States.

Speaker #3: And that is a life sciences market in Cambridge. And so that is also I think then very much a boon for us in our search.

Speaker #3: I will say, and this will not be a surprise to anyone, that the potential slate of candidates for us who are purely radio pharmaceutical or have radio pharmaceutical is very narrow.

Mary Anne Heino: It is progressing, Larry, and it's good to be talking with you again. I'm gonna say two things that I think are in our favor. I think this is an incredible opportunity for someone to step into what the future of our company and where we're going to be taking this company. I think as exciting as that is to me, I think it's also something that is exciting to the candidates we're talking to. The other thing I will say is, as everyone knows, we sit fairly adjacent to what is an incredibly active market in the United States, and that is the life sciences market in Cambridge. That has also, I think, been very much a boon for us in our search.

Speaker #3: This is just not a large industry. There's from a history perspective, there haven't been a lot of CEOs in this industry. And as you can imagine, those of us who are here probably have competitive locks from going to competitors in a role as significant as the CEO.

Speaker #3: But having said that, I will reiterate what I said. I'm very pleased with the candidates that we've met. And to me, it's also a declaration or a demonstration of how far radio pharmaceuticals have come and what they mean and represent in overall life sciences now.

Mary Anne Heino: I will say, and this will not be a surprise to anyone, that the potential slate of candidates for us who are purely radiopharmaceutical or have radiopharmaceuticals is very narrow. Just from a history perspective, there haven't been a lot of CEOs in this industry, and as you can imagine, those of us who are here probably have competitive blocks from going to competitors in a role as significant as the CEO. Having said that, I will reiterate what I said. I'm very pleased with the candidates that we've met, and to me, it's also a declaration or a demonstration of how far radiopharmaceuticals have come and what they mean and represent in overall life sciences now.

Speaker #5: Thank you. Our next question comes from Yuanzi with B. Reilly. You may proceed.

Speaker #11: Good morning. Thank you for taking all our questions. Maybe to Marianne, when comparing new receipts with the number one leader in that space, where do you see improvement opportunities to catch up in market shares?

Speaker #11: Is it availability, guidance difference, or pricing? Any additional color would be appreciated?

Speaker #3: I'm sorry. Your voice was actually very muffled while you asked your question. And we're going to have to ask you to repeat it.

Speaker #11: Yeah. I'm sorry. When comparing new receipt with the number one leader in that space, where do you see improvement opportunities to catch up in market shares?

Operator: Thank you. Our next question comes from Yuan Zhi with B. Riley. You may proceed.

Speaker #11: Is it availability, or guidance, or pricing? Anything you see opportunities in?

Yuan Zhi: Good morning. Thank you for taking our questions. Maybe to Marianne, when comparing Neuraceq to the number one leader in that space, where do you see improvement opportunities to catch up in market shares? Is it availability, guidance, difference, or pricing? Any additional color will be appreciated.

Speaker #3: Yes. I'm very well understood now. Thanks so much. Let me first start by correcting. Neuroseek is the second most utilized amyloid data imaging agent in the space.

Speaker #3: The product with the highest market share in the space right now is actually Lilly's product, Amazed. As far as where we see the growth opportunities for Neuroseek in the market short, mid, and long term is first and foremost, there have been some changes to the guidelines regarding use of amyloid imaging for diagnosis of patients with different levels of Alzheimer's disease.

Mary Anne Heino: Sorry, your voice was actually very muffled while you asked your question. We're going to have to ask you to repeat it.

Yuan Zhi: Yes, I'm sorry. When comparing Neuraceq with the number one leader in that space, where do you see improvement opportunities to catch up in market shares? Is it availability or guidance or pricing? Anything you see opportunities in?

Speaker #3: So that's the first. And very much testament to that, I think the launch and now what we see is continued uptake of the DMPs, the drug-modifying therapies for Alzheimer's disease, come with what will be associated imaging, not only to validate that the patients would be eligible for those therapies, but then there's also the potential to monitor those patients during therapy.

Mary Anne Heino: Yes, very well understood now. Thanks so much. Let me first start by correcting. Neuraceq is the second most utilized beta-amyloid imaging agent in the space. The product with the highest market share in the space right now is actually Eli Lilly, Eli Lilly's product, Amyvid. As far as where we see the growth opportunities, growth opportunities for Neuraceq in the market, short, mid, and long term is, first and foremost, there have been some changes to the guidelines regarding the use of amyloid imaging for diagnosis of patients with different levels of Alzheimer's disease.

Speaker #3: And all of those, both of those activities, would add volume to the amyloid imaging market. Finally, very specific to Neuroseek, this is not a price play.

Speaker #3: You mentioned, is this going to come from purely from price or growth? And the answer to that is no. It really is driven by two factors.

Mary Anne Heino: That's the first, and very much testament to that, I think the launch and now what we see is continued uptake of the DMTs, the drug modifying therapies for Alzheimer's disease, come with what will be associated imaging, not only to validate that the patients would be eligible for those therapies, but then there's also the potential to monitor those patients during therapy. All of those, both of those activities would add volume to the amyloid imaging market. Finally, very specific to Neuraceq, this is not a price play. You mentioned, is this gonna come from purely from price or growth? The answer to that is no. It really is driven by two factors.

Speaker #3: The first is, and most important, broadening the geographic footprint from which Neuroseek is available for distribution to all of the centers that do amyloid-based PET imaging.

Speaker #3: And the second is then within those accounts, and especially accounts where there's already a clarified relationship, deepening the penetration of Neuroseek use in those areas.

Speaker #3: You heard me refer several times throughout my comments to the nuclear medicine customer base. We feel very strongly that we have a key advantage in longstanding history.

Speaker #3: That has been the central focus of Lantheus' commercial's efforts since we were essentially launched as a company back in the late '50s. So it's a long relationship.

Mary Anne Heino: The first is, and most important, broadening the geographic footprint from which Neuraceq is available for distribution to all of the centers that do amyloid based PET imaging. The second is then, within those accounts, and especially accounts with this already a PYLARIFY relationship, deepening the penetration of Neuraceq use in those areas. You heard me refer several times throughout my comments to the nuclear medicine customer base. We feel very strongly that we have a key advantage in our relationship there. Long, longstanding history, that has been the central focus of Lantheus's commercials efforts since we were essentially launched as a company back in the late fifties. So it's a long relationship, it's a deep relationship, and it's a very trusting relationship for having brought them all the products before, but certainly PYLARIFY.

Speaker #3: It's a deep relationship. And it's a very trusting relationship for having brought them all the products before. But certainly a clarified. So where we find ourselves now, very fortunately, which we absolutely intend to take advantage of, is that we have the ability to bring a portfolio of products into this customer space.

Speaker #3: And one of those will certainly be Neuroseek. I'd also like to clarify a comment that I made before regarding the pusluma versus clarified head-to-head study about the final point about patients not being allowed to void.

Speaker #3: That is not an accurate statement. I should have what I should have said is that while patients were encouraged to drink, and they were encouraged to drink, they weren't instructed to void.

Mary Anne Heino: Where we find ourselves now, very fortunately, which we absolutely intend to take advantage of, is that we have the ability to bring a portfolio of products into this customer space, and one of those will certainly be Neuraceq. I'd also like to clarify a comment that I made before, regarding the POSLUMA versus PYLARIFY head-to-head study, about the final point about patients not being allowed to void. That is not an accurate statement. What I should have said is that while patients were encouraged to drink, they and they were encouraged to drink, they weren't instructed to void, or did not, were not, you know, made to void. I apologize for that error in how I presented it.

Speaker #3: Or did not, were not made to void. So I apologize for that error in how I presented it.

Speaker #5: Thank you. Our next question comes from Justin Walsh with Jones Trading. You may proceed.

Speaker #12: Hi. Thanks for taking the question. In the medium to long term, can you comment on your expectations for the relative revenue contributions for your product portfolio segments?

Speaker #12: Just wondering how important prostate cancer is versus other solid tumors versus neurology and PET imaging.

Speaker #3: So I absolutely am happy to comment on that. And I hope also that that kind of came through in our comments to say that while we are incredibly fortunate to have up to four approvals this year, I think I was repetitive as was Bob, and even Amanda, in sharing that we expect revenue uptake to begin significantly in 2027.

Operator: Thank you. Our next question comes from Justin Walsh with Jones Trading. You may proceed.

Speaker #3: And that really is related to the nature of how these products come out into the market and the very important considerations of ensuring that you have access and coverage as well as insurance coverage.

Justin Walsh: Hi, thanks for taking the question. In the medium to long term, can you comment on your expectations for the relative revenue contributions for your product portfolio segments? Just wondering how important prostate cancer is versus other solid tumors versus neurology and PET imaging.

Speaker #3: But here we're talking about market coverage as well in place before you commercially, you put your commercial effort really behind it. It doesn't mean we're not getting ready for the launches.

Mary Anne Heino: I absolutely am happy to comment on that, and I hope also that kind of came through in our comments to say that while we are incredibly fortunate to have up to four approvals this year, I think I was repetitive, as was Bob and even Amanda, in sharing that we expect revenue uptake to begin significantly in 2027. That really is related to the nature of how these products come out into the market and the very important considerations of ensuring that you have access and coverage, as well as insurance coverage. Here we're talking about market coverage as well, in place before you commercially, you put your commercial effort really behind it. It doesn't mean we're not getting ready for the launches.

Speaker #3: It just means that we won't execute the launches and see the return for them where saying largely in '27. From a revenue perspective, I hope you appreciate how much effort we did throughout end of '24, all through '25, to to diversify our revenue base.

Speaker #3: But going forward, it's safe to assume that revenue derived from our prostate cancer franchise of products will be the main driver. We see lovely, lovely contribution from Neuroseek.

Speaker #3: We have absolutely have strong expectations for contribution from our other launch products that we will be taking to market. But fair to say that the cornerstone and the majority of our revenue will be from clarified.

Mary Anne Heino: It just means that we won't execute the launches and see the return for them, we're saying largely in 2027. From a revenue perspective, I hope you appreciate how much effort we did throughout end of 2024, all through 2025 to diversify our revenue base. Going forward, it's safe to assume that revenue derived from our prostate cancer franchise of products will be the main driver. We see lovely contribution from Neuraceq. We absolutely have strong expectations for contributions from our other launch products that we will be taking to market. Fair to say that the cornerstone and the majority of our revenue will be from PYLARIFY.

Speaker #3: That's why for 2026, and we again repeated this several times, we are laser-focused on the transition to and introduction of our new PSMA PET formulation.

Speaker #5: Thank you. Our next question comes from Andy Sy with William Blair. You may proceed.

Speaker #13: Oh, great. Thanks for taking our question. So like Neuroseek, you're going to be launching into markets with incumbents with Octeve and the therapeutic 2003.

Speaker #13: So can you outline some product-specific and commercial infrastructure differentiations that you can leverage to gain an upper hand as you launch these two products in the future?

Mary Anne Heino: That's why for 2026, we, and we again repeated this several times, we are laser-focused on the transition to and introduction of our new PSMA PET formulation.

Speaker #13: Thank you.

Speaker #3: Yes. Very good question. Just to clarify, of course, Neuroseek is already in the market. We didn't launch Neuroseek. It's been those products have been in the market for over a decade.

Operator: Thank you. Our next question comes from Andy Hsieh with William Blair. You may proceed.

Speaker #3: But I will say that Neuroseek is the second most utilized product in what is a three-product market. Important notes about the other products that you mentioned, and we'll put 2003 aside because that's a therapeutic.

Andy Hsieh: Oh, great, thanks for taking our question. Like Neuraceq, you're going to be launching into markets with incumbents, with LNTH-2501 and the therapeutic 2003. Can you outline some product-specific and commercial infrastructure differentiations that you can leverage to gain an upper hand as you, as you launch these two products, you know, in the future? Thank you.

Speaker #3: But as Amanda mentioned in her comments, Octeve—one of the important considerations of Octeve is that it will have transitional pass-through status and reimbursement, as will our new formulation in the PSMA franchise.

Speaker #3: And so that will be an important consideration. And is an important consideration for many customers, especially given that the Octeve market is approximately 80% hospital-based and is everyone is aware the concept of transitional pass-through payment is really applicable for traditional Medicare patients who are seen in the hospital setting.

Mary Anne Heino: Yes, very good question. Just to clarify, of course, Neuraceq is already in the market. We didn't launch Neuraceq. Those products have been in the market for over a decade. I will say that Neuraceq is the second most utilized product in what is a three-product market. Important notes about the other products that you mentioned, and we'll put PNT2003 aside because that's a therapeutic. As Amanda mentioned in her comments, LNTH-2501, one of the important considerations of LNTH-2501 is that it will have transitional pass-through status and reimbursement, as will our new formulation in the PSMA franchise.

Speaker #3: So we see that as a key advantage as we take that product to market. From MK6240, which also has an approval in a PDUFA date later this year, that is a product that is already well-established through our biomarker solution business.

Speaker #3: And there we will continue to support its role as being the number one tracer used in what are the wealth of clinical trials being undertaken by pharma in the study of tau and amyloid-based Alzheimer's disease.

Mary Anne Heino: That will be an important consideration and is an important consideration for many customers, especially given that the LNTH-2501 market is approximately 80% hospital-based. As everyone is aware, the concept of transitional pass-through payment is really applicable for traditional Medicare patients who are seen in the hospital setting. We see that as a key advantage as we take that product to market. From MK-6240, which also has, you know, an approval and a PDUFA date later this year, that is a product that is already well-established through our biomarker solution business. There we will continue to support that its role as being the number one tracer used in what are the wealth of clinical trials being undertaken by pharma in the study of tau and amyloid-based Alzheimer's disease.

Speaker #5: Thank you. And as a reminder, you may reenter the queue after you ask your question. Please press star 11 on your telephone to ask a question.

Speaker #5: Our next question comes from Kemp Doliver with Brookline Capital Markets. You may proceed.

Speaker #14: Thanks. Quickly, for Bob, could the sales and marketing guidance for '26?

Speaker #13: All right. That's fine. I can manage that. So more or less what we're thinking of in terms of total OPEX, you're going to see two of our sort of three sort of OPEX categories.

Speaker #13: Sort of increase in spend. I did note specifically that we would see R&D up around that 10-11% mark. But with regard to sales and marketing, and I do think that this is when I look at consensus files, this is, I think, the one sort of underappreciation for the work that we need to put in front of '20, the different products that we're hoping to launch going into 2027.

Operator: Thank you. As a reminder, you may reenter the queue after you ask your question. Please press star one one on your telephone to ask a question. Our next question comes from Kemp Dolliver with Brookline Capital Markets. You may proceed.

Kemp Dolliver: Thanks. Quickly, for Bob, could you go through the comments again on the sales and marketing guidance for 2026?

Speaker #13: And the work, this is, and it mirrors almost what we did with clarify back in, when was that, 2021? So from that perspective, I think you're going to model it somewhere and call it the 12-ish, 12 and a half percent range of revenue.

Bob Marshall: All right, that's fine. I can manage that. So more or less what we're thinking of in terms of like total OpEx, you're gonna see two of our sort of three OpEx categories, sort of increase in spend. I did note specifically that we would see R&D up around that 10, 11% mark. With regard to sales and marketing, and I do think that this is when I look at consensus files. This is, I think, the one sort of like under appreciation for the work that we need to put in front of 20, you know, the different products that we're hoping to launch, you know, going into 2027. The work, this is and it mirrors almost what we did with PYLARIFY back in, when was that? 2021.

Speaker #13: And that, I think, together with a flat G&A again, keeping some leverage in those functions that are supporting. But really kind of putting the money in the investment where we hope to see a solid return for shareholders.

Speaker #13: That's how you should model things.

Speaker #5: Thank you. Ladies and gentlemen, there are no further.

Speaker #3: Oh, sorry. I just did want to add a comment there. That kind of finishes out Bob's thought. I think also what we were also trying to communicate, that's important here, is that we have leveraged as we take these new launches through and certainly sales and marketing expenses part of that, as we take these new launches out to the market, that one of the great opportunities we have is leverage as we've already got a full voice and presence with those that customer base.

Mary Anne Heino: Mm-hmm.

Bob Marshall: From that perspective, I think you're gonna model it somewhere in, call it the 12-ish, 12.5% range of revenue. That, I think, together with a flat G&A, you know, again, keeping some leverage in those functions that are supporting, but really kind of putting the money in the investment where we hope to see a solid return for shareholders. That's how you should model things.

Speaker #3: So you heard me saying, I'll repeat it again, fit for purpose investments commensurate with the opportunity. But also with the investments we've made prior in those same customer bases.

Speaker #3: And I would say overall in the channel.

Operator: Thank you. Ladies and gentlemen, there are no further-

Speaker #5: Thank you. Ladies and gentlemen, there are no further questions at this time. Thank you for participating in today's conference. This concludes the program. You may disconnect and have a wonderful day.

Mary Anne Heino: Oh, sorry. I just did want to add a comment there, that kind of finishes out Bob's thought. I think also what we were also trying to communicate that's important here, is that we have leverage as we take these new launches through, and certainly sales and marketing expense is part of that, as we take these new launches out to the market, that one of the great opportunities we have is leverage, as we've already got a full voice and presence with those, that customer base. You heard me say, and I'll repeat it again, fit for purpose investments commensurate with the opportunity, but also with the investments we've made prior in those same customer bases. I would say overall in the channel.

Operator: Thank you. Ladies and gentlemen, there are no further questions at this time. Thank you for participating in today's conference. This concludes the program. You may disconnect and have a wonderful day.

Q4 2025 Lantheus Holdings Inc Earnings Call

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