Lantheus (LNTH) Q4 2025 Earnings Call Transcript

Image source: The Motley Fool.

DATE

Thursday, Feb. 26, 2026 at 8 a.m. ET

CALL PARTICIPANTS

• Interim Chief Executive Officer — Mary Anne Heino
• President — Amanda Morgan
• Chief Financial Officer — Robert J. Marshall

TAKEAWAYS

• Revenue -- $406.8 million in the fourth quarter and $1,541.6 million for the full year (calendar year 2025), with a $31 million fourth-quarter contribution from Neuraceq, and $85.3 million from DEFINITY.
• PYLARIFY performance -- Fourth-quarter revenue of $240.2 million, flat sequentially and down 9.7%; full-year revenue of $989.1 million, down 6.5%.
• Precision diagnostics -- Fourth-quarter revenue of $143.2 million, up 22%; driven by DEFINITY at $85.3 million (down 1% due to prior-year competitor supply challenges), and Neuraceq at $31 million.
• Strategic acquisitions -- Neuraceq acquired and now serves as the cornerstone of the Alzheimer’s portfolio; OCTEVY acquired and under FDA review for GEP-NET PET imaging, with launch planned upon approval.
• PYLARIFY franchise outlook -- 2026 guidance anticipates 8%-10% year-over-year revenue decline in PYLARIFY, with volume gains offset by price erosion; sequential quarterly revenue expected to remain stable.
• Gross profit margin -- 65.1% for the fourth quarter, down 289 basis points due to PYLARIFY price declines and inclusion of new manufacturing and Neuraceq volumes.
• Operating cash flow -- $90.2 million in the fourth quarter; free cash flow of $81.4 million, down $60 million primarily from working capital movements linked to the SPECT divestiture and PMF network expansion.
• Share repurchases -- $100 million, or 1.77 million shares, repurchased during the quarter; $200 million authorization remains.
• 2026 financial guidance -- Projected worldwide net revenue of $1.4 billion-$1.45 billion, gross margin at approximately 65.5%, R&D at 10%-11% of revenue, and EPS in the $5.00-$5.25 range based on 66 million average fully diluted shares.
• Pipeline and approvals -- Four registrational stage products, including a new PSMA PET formulation with a PDUFA date of March 6, 2026; OCTEVY with a PDUFA date of March 29, 2026; PNT2003 pending FDA review and litigation outcome; and MK-6240 with a PDUFA date of Aug. 13, 2026.
• SPECT business divestiture -- Divestiture completed Jan. 1, 2026, removing $111.4 million from the prior-year baseline; focus shifted fully to PET radiodiagnostics.
• Neuraceq growth -- Expected to deliver inorganic triple-digit growth in 2026, aided by onboarding six additional PMF sites and leveraging portfolio customer relationships.
• Therapeutics portfolio -- Management evaluating value-maximizing alternatives for radiotherapeutic assets, with no significant M&A planned in 2026, and focus on commercial integration of recent acquisitions.
• Adjusted EPS baseline -- Normalized 2025 adjusted EPS for ongoing business at $5.75, after accounting for SPECT divestiture and one-time items; 2026 guidance is based on this adjusted figure rather than reported numbers.
• Operational priorities -- 2026 priorities include smooth PYLARIFY transition to new formulation, growing Neuraceq presence, driving regulatory assets to approval, and leveraging commercial infrastructure for multiple launch preparedness.

RISKS

• PYLARIFY revenue decline -- "We see PYLARIFY net revenue declining 8%-10% year over year, consisting of increased volume, offset by modest price erosion," reflecting renewed competition and end of pass-through reimbursement for a competing agent in September 2026.
• Margin pressure -- Gross margin declined 289 basis points due to "year-over-year decreases in PYLARIFY net price" and additional manufacturing costs, which may persist as product mix shifts.
• Cash flow decrease -- Free cash flow fell by $60 million year over year, impacted by $49.3 million less working capital and increased inventory linked to product and manufacturing expansion.
• Higher operating expenses -- R&D is projected to rise by approximately 200 basis points to 10%-11% of revenue, and sales and marketing is projected at 12%-12.5% of revenue, elevating fixed costs ahead of anticipated revenue from future product launches.

SUMMARY

Lantheus (NASDAQ:LNTH) emphasized a strategic pivot to PET radiodiagnostics, highlighted by the divestiture of its SPECT business on Jan. 1, 2026, and the acquisitions of Neuraceq and OCTEVY, with four near-term FDA approval catalysts identified. Management stated that 2026 will be a year of investment in commercialization infrastructure, with the majority of revenue growth acceleration and portfolio diversification expected in 2027 following late-year product launches. The company will also optimize its cost base and reassess its radiotherapeutic pipeline for value-maximizing externalization or partnerships, indicating a restrained near-term M&A approach.

• Mary Anne Heino said, "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."
• Robert J. Marshall clarified that the SPECT divestiture and a $6 million out-licensing milestone together reduce the 2025 baseline revenue by $117.4 million, and that investors should model comparisons excluding these items.
• Amanda Morgan stated that Neuraceq is positioned as "the already second-most utilized and fastest-growing beta-amyloid PET imaging agent," with manufacturing network expansions planned to support further growth.
• The company expects no "meaningful revenue contribution" from pending product approvals in 2026, attributing this to required steps in coding, payer readiness, and phased launch execution.
• Management disclosed the comprehensive review of radiotherapeutic assets with the intent to "pursue value-maximizing alternatives," separating near-commercial PNT2003 from other pipeline therapies under review for partnered development or externalization.

INDUSTRY GLOSSARY

• PMF (Positron Manufacturing Facility): Specialized site certified for production of F-18-based PET radiodiagnostics, a key determinant of geographic supply and product availability.
• PDUFA date: The FDA target action date under the Prescription Drug User Fee Act for completing review of new drug applications or biologics license applications.
• Transitional pass-through (TPT) reimbursement: Temporary additional Medicare payment for qualifying new drugs and devices, significant in supporting hospital-based PET product adoption.
• GRPR (Gastrin-Releasing Peptide Receptor): A molecular target for prostate cancer radiodiagnostics distinct from PSMA, enabling disease detection in patients with low or negative PSMA expression.
• GEP-NET: Gastroenteropancreatic neuroendocrine tumors, a focus of developing PET radiodiagnostic agents such as OCTEVY and PNT2003 in the company's pipeline.
• HCPCS code: Healthcare Common Procedure Coding System used for insurance reimbursement and coverage for new drug formulations.

Full Conference Call Transcript

Mary Anne Heino: Thank you, Mark, and good morning, everyone. It is 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 Holdings, Inc. CEO, I am 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, and I am pleased with the candidates we have met thus far. Before I offer comments about our business achievements for 2025, I would first like to share that Lantheus Holdings, Inc. 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 2 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. In 2026, we expect Neuraceq's growth will exceed that of the overall market. Second, our acquired product candidate OCTEVY, a neuroendocrine PET radiodiagnostic currently under FDA review. Upon approval, OCTEVY 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 Holdings, Inc. 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. 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. An estimated 15%-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 Holdings, Inc. now has the broadest radiodiagnostic pipeline among our peers in the radiopharmaceutical space. Finally, we completed the divestiture of our legacy SPECT business on January 1, 2026.

While the SPECT business was foundational to Lantheus Holdings, Inc.'s 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 fourth quarter of 2026, with the material commercial impact of that launch beginning in 2027. In neurology, we are excited to drive momentum with Neuraceq through expansion of our PMF 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 Holdings, Inc. products in 2026 and beyond.

We have the potential for multiple FDA approvals this year. The first, our new PSMA PET formulation, second, OCTEVY, third, PNT2003, our radioequivalent formulation of Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors or GEP-NET, 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. 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 and beyond. As I have 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. 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. She will then 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 us discuss our fourth quarter results and priorities for 2026. I will begin with PYLARIFY, 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. 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 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. 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.

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 six additional PMF sites. 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 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. 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. 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. 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 3 radiodiagnostic assets and one radioequivalent therapeutic with near-term regulatory approval timelines. First, our new PSMA PET formulation, with a PDUFA date of March 6, 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 PMF network in place, as our focus will be on supply continuity.

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 the fourth quarter of 2026, which will minimize risk during the commercial launch.

We believe these actions position a new formulation for continuous, sustainable growth beginning in 2027. Second, OCTEVY, our gallium-based PET radiodiagnostic for NETs, with a PDUFA date of March 29, will support clinical decision-making in patients with neuroendocrine tumors. Assuming FDA approval, we will have the opportunity to launch OCTEVY as the only neuroendocrine PET radiodiagnostic with transitional pass-through reimbursement. As a gallium-based agent, OCTEVY will be offered through existing radiopharmacy networks, which Lantheus Holdings, Inc. 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. PNT2003, like OCTEVY, will be a natural addition to the Lantheus Holdings, Inc. 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 August 13 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. 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 will now turn the call over to Bob to provide more detail on our fourth quarter and full-year results and outlook. Bob?

Robert J. Marshall: Thank you, Amanda, 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. 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 0.5%. Turning to the details, radiopharmaceutical oncology, currently comprised solely of PYLARIFY, generated fourth quarter 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.

Precision Diagnostics delivered fourth quarter 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 the fourth quarter and $111.4 million for the full year.

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 the fourth quarter was 65.1%, down 289 basis points from the fourth quarter 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.

Operating expenses at 30.9% of net revenue were 179 basis points unfavorable from the prior year, but 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 LMI 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. 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.

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. GAAP fully diluted earnings per share for the fourth quarter 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. 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.

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. 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 January 1. 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.

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 2026, there are a number of line items that we would 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 January 1, 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 the fourth quarter.

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. Further, the company recognized approximately $4 million or $0.04 of employee retention credit benefits occurring in Q2 of 2025, also not likely to repeat. Therefore, the appropriate adjusted EPS comparison should be $5.75. 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 do not anticipate meaningful revenue contribution this year.

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. 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 its transitional pass-through period as of September 30. We see PYLARIFY net revenue declining 8%-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. This includes the fourth quarter, 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. DEFINITY is expected to grow low to mid-single digits. Taken together, we forecast worldwide net revenue of $1.4 billion-$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 OCTEVY, to ensure broad availability and access. R&D is expected to move to 10%-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 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. Altogether, we forecast EPS in a range of $5.00-$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. 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 Anne.

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 the fourth quarter. 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. 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.

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. I will now turn it over to Q&A. Operator?

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

Anthony Charles Petrone: Thank you, hi, Mary Anne, welcome back. Hope you are doing well. Hi, Bob, Amanda, Mark, hope everyone is doing well. Maybe I will start off with 2 quick ones. Just know a lot of folks are on the line here, but start with, you know, just the March 6 PDUFA date for next gen PSMA PET imaging agent. Thanks for the updates there on a fourth quarter 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, 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 will have one quick follow-up. Thanks.

Mary Anne Heino: Anthony, I will take that, 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 are assuming here, that will also then, I think, explain our strategy as we move forward. As you noted, our PDUFA date is March 6. The two 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.

We would anticipate that we would have in place by October 1, our HCPCS code, and that for having submitted our transitional pass-through application by June 1, that will also be in place by October 1. It is 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 PMF. 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 PMF separately because they each represent a GMP-approved manufacturing site.

Our goal is to make sure that we never have disruption of product Lantheus Holdings, Inc. product availability in that market. We have 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 is approved. And we anticipate for making sure that is the risk, that will take us the fourth quarter to accomplish.

Coming out of the fourth quarter, we will have a network as broad as we have in place currently for PYLARIFY in place for our new formulation, and 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 have got all bases covered here. We are all, you know, waiting for the March 6 date. 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 have heard from the FDA.

Anthony Charles Petrone: Excellent. Just a quick one is just the market dynamics for PYLARIFY, as is today, down 8%-10%. We know that there is 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%-10% per share shift? How does the outcome of the study play into that? Thanks again. Welcome back.

Mary Anne Heino: Thanks, Anthony. 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, there is no randomization in the study. If you read the protocol and you see how it was executed, the PYLARIFY images were always captured first. In a fully randomized trial, you would probably expect to see something different. Also what is concerning, there is no truth standard. If you look at the design of the study, they are really measuring just SUV and detection rate.

The kind of the odd thing about 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. Also, if it is just from a math perspective, the study was not powered to show statistical significance. From a clinical perspective, there is 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 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? The results of that study really do not bake into our forecast.

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

Richard Samuel Newitter: Hi, thanks for taking the questions. 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 the third quarter, you had about a 500 basis point, 340B driven price headwind to contend with in the fourth quarter. I am getting to, like, a high single digit unit growth rate in Q4. 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 26 for PYLARIFY and kinda what your unit and price assumptions kinda are within that? Thank you.

Robert J. Marshall: Rich, I will 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 fourth quarter, you know, following our call and whatnot, we had sort of pegged it at sort of the mid-teens, and that is effectively what we saw. That was maybe slightly more favorable than the actual teens growth that we were kind of thinking.

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 are 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 have done is that while we have 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 pass-through, that they may actually look to try to use pricing as a mechanism to drive share. We have been really pretty disciplined, and we have been really explicit that as we think about executing our strategy, that we are going to stay disciplined. We are not going to 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 is why you see sort of what I have laid out as sort of a sequentially net revenue, sort of neutral outcome for each of the quarters throughout 2026.

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

Richard Samuel Newitter: Yeah, it does. It sounds like you are not seeing any dramatic changes to the pricing environment currently. To be prudent, you are because this is what took you by surprise and all of us by surprise last year, you are embedding that assumption that there will be another kinda regular way price erosion situation, or you will have to walk away from that business incrementally. That is a placeholder in your guide, and you do not really assume any contribution from two-point-o. There could be upside if those things do not play out that way, and you start to get some benefit from two-point-o, 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: Yep. Rich, absolutely. I have to say, it is 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 are thinking about the market.

Richard Samuel Newitter: Okay. Thank you, guys.

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

Roanna Clarissa 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 are looking for? Could this be part of near-term BD? I know you mentioned on the comments, possible tuck-ins this year, I was just curious if you could explain a bit more there.

Mary Anne Heino: Absolutely. I am 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 25 and even 24. We have now a very broad portfolio of both diagnostic and therapeutic assets, 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 have chosen to focus in on the diagnostic asset then.

As you will see, I had a pipeline slide in the middle of my presentation, it will also show it again at the end. It really is a very broad portfolio there. When we refer to the therapeutic assets, what we are 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, so that 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. If we find them and they fit, then, yes, absolutely, we will consider them. Even as we talk about the therapeutic assets, I probably should be clear to say that when I talk about that, I am not talking about PNT2003. That product is right before us as far as regulatory approval opportunity. It is 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.

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

Matthew Charles Taylor: Hi, good morning. Thanks for taking the question. I guess I will 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 is a bad growth rate, but why could not it actually be higher than that, given the momentum that you have and also the sequential growth that we are seeing in some of these Alzheimer therapeutics?

Mary Anne Heino: Matt. We absolutely do see... triple digits, pretty good to hear, Matt. I think what you are also hearing from us, again, we inherited that product as of, we will call it, midyear 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 PMFs for Neuraceq at the time we acquired it was, call it, mid-20s.

We added a few, and someone might correct me if I am wrong there, 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. I am sorry, I have been corrected. The starting number of PMFs when we inherited the product was 16, and again, we will continue to add. That really is our 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 Holdings, Inc. products. Happy to be wrong here and have it even further exceed what we have, but I think we have been very practical, optimistic, but practical with our forecast. Bob, do you want to add something there?

Robert J. Marshall: I do, because well, people can figure this out from a mathematical situation. By triple digits, we are talking certainly in, like, call it the 140%-150% 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.

Operator: Thank you.

Mary Anne Heino: Does that answer your question?

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

Karishma (for Paul Choi): Hi, thank you for taking our question. This is Karishma on for Paul. 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? Thank you so much.

Mary Anne Heino: I am sorry, could you repeat what you are referring to? No, the study. Can you repeat the first part of your question, please?

Karishma (for Paul Choi): Yeah, sorry. If the upcoming Biogen data shows meaningful tau reduction, but no benefit—

Mary Anne Heino: Oh, yes.

Karishma (for Paul Choi): —on cognitive measures, how does this affect your go-forward investment in your tau program? Thank you.

Mary Anne Heino: Okay. I am sorry, there was, we just did not hear the first part of your question, but it makes the perfect sense. We will, of course, are very eagerly awaiting those data, but I think there is 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 is slightly different than the role that amyloid plays.

Amyloid, and, you know, to think about it, I guess, bluntly, amyloid comes early, but it does not 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. I think what we are seeing in this market, and we are kind of all seeing it in real time because that is the wonderful thing that is happening around us. There really is now a market that is willing and acting on taking these products 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 will not 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. As you heard, Amanda mention, in our biomarker business, tau is our product, MK-6240, is the number one product that is used in what we see as the 17 underlying, the ongoing studies in the market.

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

Lawrence Scott Solow: Great, thank you, I echo the welcome back, Marianne. It sounds like the CEO search is progressing though. You know, is this gonna be like a, do you feel like it is a 6-month, 12-month type of thing? Any thoughts on just timing?

Mary Anne Heino: It, it is progressing, Larry, and it is good to be talking with you again. I am 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 are going to be taking this company. I think as exciting as that is to me, I think it is also something that is exciting to the candidates we are 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 is also, I think, been very much a boon for us in our search. I will say, this will not be a surprise to anyone, that the potential slate of candidates for us who are purely radiopharmaceutical or have radiopharmaceutical, is very narrow. This is just not a large industry. There, just from a history perspective, there have not been a lot of CEOs in this industry. 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 am very pleased with the candidates that we have met, and to me, it is also a declaration or a demonstration of how far radiopharmaceuticals have come, and what they mean and represent in overall life sciences now.

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

Yuan Zhi: Good morning. Thank you for taking our questions. Maybe to Mary Anne, 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.

Mary Anne Heino: Sorry, your voice was actually very muffled, while you asked your question, and we are going to have to ask you to repeat it.

Yuan Zhi: Yes, I am 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?

Mary Anne Heino: 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 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 beta-amyloid imaging for diagnosis of patients with different levels of Alzheimer's disease. That is the first, and it is very much testament to that.

I think the launch and now that 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 is 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.

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, 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 Holdings, Inc.'s commercials efforts since we were essentially launched as a company back in the late 50s.

It is a long relationship, it is a deep relationship, and it is a very trusting relationship for having brought them all the products before, but certainly PYLARIFY. 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. One of those will certainly be Neuraceq. I would 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 were not instructed to void, or did not, were not, you know, made to void. I apologize for that error in how I presented it.

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

Justin Howard 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.

Mary Anne Heino: I absolutely am happy to comment on that, 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. The very important considerations of ensuring that you have access and coverage, as well as insurance coverage, but here we are talking about market coverage as well, in place before you commercially, you put your commercial effort really behind it.

It does not mean we are not getting ready for the launches; it just means that we will not execute the launches, and see the return for them, we are 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 is 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 have, absolutely have strong expectations for contribution 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. That is why for 2026, we... We again repeated this several times, we are laser-focused on the transition to and introduction of our new PSMA PET formulation.

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

Tsan-Yu Hsieh: Great, thanks for taking our question. Like a Neuraceq, you are going to be launching into markets with incumbents with Pluvicto 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 launch these two products, you know, in the future? Thank you.

Mary Anne Heino: Yes, the very good question. Just to clarify, of course, Neuraceq is already in the market. We did not 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 3-product market. Important notes about the other products that you mentioned, we will put PNT2003 aside because that is a therapeutic. As Amanda mentioned in her comments, Pluvicto, one of the important considerations of Pluvicto is that it will have transitional pass-through status and reimbursement, as will our new formulation in the PSMA franchise.

That will be an important consideration and is an important consideration for many customers, especially given that the Pluvicto 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, and 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.

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

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

Robert J. Marshall: All right. That is fine. I can manage that. More or less what we are thinking of in terms of like total OpEx, you are gonna see two of our sort of three sort of 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 underappreciation for the work that we need to put in front of 20, you know, the different products that we are hoping to launch, you know, going into 2027.

The work and it mirrors almost what we did with PYLARIFY back in, when was that? 2021.

Mary Anne Heino: Mm-hmm.

Robert J. Marshall: From that perspective, I think you are 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 is how you should model things.

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 is 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 have already got a full voice and presence, with those, that customer base.

You heard me say, and I will repeat it again, fit for purpose investments commensurate with the opportunity, but also with the investments we have 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.

This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. Parts of this article were created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.

The Motley Fool has positions in and recommends Lantheus. The Motley Fool has a disclosure policy.