2/26/2026

speaker
Operator
Conference Operator

Good morning. Welcome to Lanthea's 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 two 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 Canarni, Vice President of Investor Relations. Mark.

speaker
Mark Canarni
Vice President of Investor Relations

Thank you. Good morning. With me today are Mary Ann Haino, 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 8K, reporting our fourth quarter and full year 2025 results. The release and today's slide presentation are available on the investor 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 Ann.

speaker
Mary Ann Haino
CEO and Executive Chairperson (Interim)

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. While my role as CEO will be interim as we complete the search for the next Lancia 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, 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 Lanthea's product 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 streams across our commercial radio diagnostic portfolio. First, the acquisition of NeuroSeq, 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 NeuroSeq and the expanding amyloid pet imaging market. And in 2026, we expect Neuroseq's growth will exceed that of the overall market. Second, our acquired product candidate, Octevi, a neuroendocrine PET radio diagnostic currently under FDA review. Upon approval, Octevi 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 Neuroseq. In 2025, we also took meaningful steps to further build out the portfolio of radiodiagnostic products LAMBIUS offers to the prostate cancer community. Our primary focus in 2025 was defending our leadership position in the PSMA PET imaging space with Polarify. 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 three ready gastrin-releasing peptide receptor, or GRPR, targeted radio diagnostic 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. That transition will take place With these acquisitions and the other activities accomplished to build out our pipeline, we believe that Lampias now has the broadest radio diagnostic pipeline among our peers in the radiopharmaceutical space. Finally, we completed the divestiture of our legacy spec business on January 1st of 2026. While the spec business was foundational to Lampias' 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. 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. 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 registration stage products. Our top priority is to maintain and strengthen our leadership in PSMA PET by sustaining polarized 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 NeuroSeq through expansion of our PMF manufacturing network, as well as the opportunity of introducing NeuroSeq to our existing nuclear medicine Polarify customers. NeuroSeq, 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. We have the potential for multiple SEA 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 JETNES. And fourth, MK6240, our cow-targeted PET radio diagnostic. Assuming approval for each of these products, commercialization plan will be thoroughly targeted to align with market and access readiness an approach we believe underpinned our successful polarify launch 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 investment going forward will focus on radio diagnostics 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 radio diagnostic assets that complement our current commercialized portfolio and our nuclear medicine customer base. As part of this strategy, we have decided to pursue 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, so 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?

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