Q2 2024 Lantheus Holdings Inc Earnings Call

Good morning. Welcome to the Lantheus fourth quarter and full year 2024 conference call. This is your operator for today's call. Please note that all lines have been placed on mute to limit background noise.

Operator: This is your operator for today's call. Please note that all lines have been placed on mute to limit background noise. This call is being recorded.

Operator: 24 Conference Call. This is your operator for today's call. Please note that all lines have been placed on mute to limit background noise. This call is being recorded.

Operator: A replay will be available in the investor's section of the company's website approximately two hours after the completion of the call and will be archived for at least 30 days.

Speaker Change: This call is being recorded. 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.

Mark Kinarney: I'll now turn the call over to your host for today.

Operator: 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 your host for today, Mark Kinarney, Vice President of Investor Relations. Thank you. Good morning, and welcome to today's call. With me today are Brian Markison, our CEO; Paul Blanchfield, our President; Bob Marshall, our CFO; Jeff Humphrey, our Chief Medical Officer; and Amanda Morgan, our Chief Commercial Officer. We will begin the call with prepared remarks and then open the call for Q&A.

Mark Kinarney: Mark Kinarney, Vice President of Investor Relations.

I'll now turn the call over to your host for today, Mark Kinarney, Vice President of Investor Relations.

Mark Kinarney: Mark? Thank you.

Mark Kinarney: Good morning and welcome to today's call. With me today are Brian Markison, our CEO, Paul Blanchfield, our President, Bob Marshall, our CFO, Jeff Humphrey, our Chief Medical Officer, and Amanda Morgan, our Chief Commercial Officer. We will begin the call with prepared remarks and then open the call for Q&A.

Mark Richard Kinarney: Thank you. Good morning and welcome to today's call. With me today are Brian Markison, our CEO , Paul Blanchfield, our President, Bob Marshall, our CFO , Jeff Humphrey, our Chief Medical Officer, and Amanda Morgan, our Chief Commercial Officer. We will begin the call with prepared remarks and then open the call for Q&A.

Mark Kinarney: This morning, we issued a press release which was furnished to the SEC under Form 8-K reporting our second quarter 2024 results. The release and today's slide presentation are in the investor's section of our website.

Mark Richard Kinarney: This morning we issued a press release which was furnished to the SEC under Form 8K, reporting our second quarter 2024 results. The release and today's slide presentation are in the investor section of our website. Any comments made during our call could include forward-looking statements. However, actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filing.

Mark Richard Kinarney: This morning we issued a press release, which was furnished to the SEC under Form 8K, reporting our second quarter 2024 results.

Mark Kinarney: Any comments made during our call 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 during this call will also include certain on-gap financial measures. Reconciliation of these measures to the most directly comparable gap financial measures is included in the investor's section of our website.

Mark Richard Kinarney: The release and today's slide presentation are in the investors section of our website.

Mark Richard Kinarney: Any comments made during our call 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.

Mark Richard Kinarney: Discussions during this call will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the investor section of our website. I will now turn the call over to our CEO, Brian. Thank you, Mark, and good morning, everyone. At Lantheus, we are the leading radiopharmaceutical focus company with a clear purpose to find, fight, and follow disease to deliver better patient outcomes. Last quarter, we outlined our strategy to enhance our leadership by maximizing the value of our existing portfolio and expanding our innovative pipeline of radiopharmaceuticals through focused business development and M&A, all while sustaining a strengthening and attractive financial profile.

Mark Richard Kinarney: Discussions during this call will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the investor section of our website. I will now turn the call over to our CEO , Brian .

Brian Markison: I will now turn the call over to our CEO, Brian. Thank you, Mark, and good morning, everyone. At Lantius, we are the leading radio pharmaceutical focus company with a clear purpose to find, fight, and follow disease to deliver better patient outcomes. Last quarter, we outlined our strategy to enhance our leadership by maximizing the value of our existing portfolio and expanding our innovative pipeline of radio pharmaceuticals through focused business development and M&A, all while sustaining a strengthening and attractive financial profile. Our continued operational performance, financial discipline, and growing pipeline will enable us to create long-term sustainable value.

Brian: Thank you, Mark. And good morning, everyone. At Lantheus, we are the leading radiopharmaceutical-focused company with a clear purpose to find, fight, and follow disease to deliver better patient outcomes.

Brian: Last quarter, we outlined our strategy to enhance our leadership by maximizing the value of our existing portfolio and expanding our innovative pipeline of radio pharmaceuticals through focused business development and M&A, all while sustaining a strengthening and attractive financial profile.

Mark Richard Kinarney: Our continued operational performance, financial discipline, and growing pipeline will enable us to create long-term, sustainable value. We delivered another strong quarter led by our commercial products, Polarify, DFINITY, and Technolite. I am particularly proud to share that since the beginning of 2024, our products have positively impacted the lives of more than 3.4 million patients and their families. You will hear more about the quarter from Paul and Bob in just a few moments.

Brian: Our continued operational performance, financial discipline, and growing pipeline will enable us to create long-term, sustainable value.

Brian Markison: We delivered another strong quarter led by our commercial products to clarify the affinity and technology. I am particularly proud to share that since the beginning of 2024, our products have positively impacted the lives of more than 3.4 million patients and their families. You will hear more about the quarter from Paul and Bob in just a few moments. Beyond our commercial portfolio, we progressed our pipeline and utilized the strength of our balance sheet to execute three strategic transactions. We are expanding our pipeline with a mix of late and early stage assets that have the potential to address high unmet medical needs.

Brian: We delivered another strong quarter led by our commercial products, Polarify, DFINITY, and Technolite.

Brian: I am particularly proud to share that since the beginning of 2024, our products have positively impacted the lives of more than 3.4 million patients and their families.

Speaker Change: You will hear more about the quarter from Paul and Bob in just a few moments.

Brian A. Markison: Beyond our commercial portfolio, we progressed our pipeline and utilized the strength of our balance sheet to execute three strategic transactions. We are expanding our pipeline with a mix of late and early stage assets that have the potential to address high unmet medical needs. Please leave your message for 5 7 1 3 5 3 9 4. Most recently, we announced the acquisition of NAV4694, a late-stage, next-generation F18 pad imaging agent candidate targeting beta amyloid and Alzheimer's disease.

Speaker Change: Beyond our commercial portfolio, we progressed our pipeline and utilized the strength of our balance sheet to execute three strategic transactions.

Speaker Change: We are expanding our pipeline with a mix of late and early stage assets that have the potential to address high unmet medical needs.

Brian Markison: Please leave your message. Most recently, we announced the acquisition of NAB 4694, a late stage next generation F18 PET imaging agent candidate targeting beta amyloid and Alzheimer's disease. We entered the Alzheimer's diagnostic space in 2023, when we acquired MK6240, our novel clinical stage tau targeting F18 PET imaging agent candidate, and we now have two complementary next generation Alzheimer's disease diagnostic candidates that we believe could provide critical insights for diagnosis, staging, and monitoring. As more therapeutic options become available, it is pivotal time for us to advance new diagnostics to address Alzheimer's disease. We also acquired the global rights to Life Molecular Imaging's RM2, clinical stage, radio diagnostic, and radiotherapeutic pair.

Speaker Change: Please leave your message for 5 7 1 3 5 3 9 4

Speaker Change: Most recently, we announced the acquisition of NAV4694, a late-stage, next-generation F18 PET imaging agent candidate targeting beta-amyloid and Alzheimer's disease.

Brian A. Markison: We entered the Alzheimer's diagnostic space in 2023 when we acquired MK6240, our novel clinical stage tau targeting F18 PET imaging agent candidate. And we now have two complementary next-generation Alzheimer's disease diagnostic candidates that we believe could provide critical insights for diagnosis, staging, and monitoring. As more therapeutic options become available, it is a pivotal time for us to advance new diagnostics to address Alzheimer's disease. We have also acquired the global rights to Life Molecular Imaging's RM2 clinical stage radiodiagnostic and radiotherapeutic pair.

Speaker Change: We entered the Alzheimer's diagnostic space in 2023.

Speaker Change: When we acquired MK6240,

Speaker Change: Our Novel Clinical Stage Tau Targeting F18 PET Imaging Agent Candidate

Speaker Change: And we now have two.

Speaker Change: complementary next-generation Alzheimer's disease diagnostic candidates that we believe could provide critical insights for diagnosis, staging, and monitoring.

Speaker Change: As more therapeutic options become available, it is pivotal time for us to advance new diagnostics to address Alzheimer's disease.

Brian A. Markison: Gallium-RM2 and Lutetium-RM2, also known as LMTH2401 and 2402, target the gastrin-releasing peptide receptor, or GRPR. This potentially best-in-class theranostic pair fortifies our oncology pipeline and will potentially take us into new disease areas. GRPR is minimally expressed in healthy prostate cells and overexpressed in 75% to 100% of prostate cancer cells.

Speaker Change: We also acquired the global rights to Life Molecular Imaging's RM2 clinical stage radiodiagnostic and radiotherapeutic pair.

Brian A. Markison: And because it's highly correlated with androgen expression, RM2 could potentially be used in earlier stages of disease. In addition, the 15 to 25% of metastatic castration resistant prostate cancer patients having low to no PSMA expression, we believe this theranostic pair could be a valuable addition to the prostate cancer community. We plan to work with Life Molecular to initiate a phase one, two, a prostate cancer study as soon as practicable. Additionally, this quarter, we licensed two product candidates from Radiophant Theranos.

Brian Markison: Gallium RM2 and LTCM RM2, also known as LNTH20401 and 20402, target the gastrin releasing peptide receptor or GRPR. This potentially best-than-class thermonastic pair fortifies our oncology pipeline and will potentially take us into new disease areas. GRPR is minimally expressed in healthy prostate cells and overexpressed in 75 to 100 percent of prostate cancer cells and is highly correlated with antigen expression. RM2 could potentially be used in earlier stages of disease. In addition to 15 to 25 percent of metastatic castration, resist, and prostate cancer patients having low to no PSM expression, we believe this thermonastic pair could be a valuable addition to the prostate cancer community.

Speaker Change: Gallium-RM2 and Lutetium-RM2, also known as LMTH-2401 and LMTH-2402, target the gastrin-releasing peptide receptor, or GRPR.

Speaker Change: This potentially best-in-class theranostic pair fortifies our oncology pipeline and will potentially take us into new disease areas.

Speaker Change: GRPR is minimally expressed in healthy prostate cells and overexpressed in 75-100% of prostate cancer cells and is highly correlated with androgen expression. RM2 could potentially be used in earlier stages of disease.

Speaker Change: In addition, the 15 to 25 percent of metastatic castration-resistant prostate cancer patients having low to no PSMA expression, we believe this theranostic pair could be a valuable addition to the prostate cancer community.

Brian Markison: We plan to work with Life Molecular to initiate a phase one to a prostate cancer study as soon as practical. Additionally, this quarter relies on two product candidates from radiophonic darodostics. This includes an LRRC-15 targeted monoclonal antibody, which is a potential first-in-class highly specific radio conjugate with both orphan drug and rare pediatric disease designations from the FDA for the treatment of osteosarcoma. The agent is designed to target the surrounding tumor microenvironment cells expressing the protein, potentially treating a broad range of cancers. The second candidate is a troop-to-targeted nanobody radio conjugate, which has best-than-class potential and is advancing in preclinical development.

Speaker Change: We plan to work with Life Molecular to initiate a Phase I-IIa prostate cancer study as soon as practical.

Brian A. Markison: This includes an LRRC15-targeted monoclonal antibody, which is a potential first-in-class, highly specific radioconjugate with both orphan drug and rare pediatric disease designations from the FDA for the treatment of osteosarcoma. The agent is designed to target the surrounding tumor microenvironment cells expressing the protein, potentially treating a broad range of cancers. The second candidate is a Trope 2-targeted nanobody radioconjugate which has best-in-class potential and is advancing in preclinical development.

Speaker Change: Additionally, this quarter we licensed two product candidates from Radiopharm Theranostics.

Speaker Change: This includes an LRRC15-targeted monoclonal antibody, which is a potential first-in-class, highly specific radioconjugate with both orphan drug and rare pediatric disease designations from the FDA for the treatment of osteosarcoma.

Speaker Change: The agent is designed to target the surrounding tumor microenvironment cells expressing the protein potentially treating a broad range of cancers.

Speaker Change: The second candidate is a Trope 2-targeted nanobody radioconjugate, which has best-in-class potential and is advancing in preclinical development.

Brian Markison: We look forward to updating you on our progress as we continue to thoughtfully build out our portfolio.

Paul M. Blanchfield: We look forward to updating you on our progress as we continue to thoughtfully build out our portfolio. And with that, I'd like to now turn the call over to Paul to provide an operational update. Thank you, Brian.

Speaker Change: We look forward to updating you on our progress as we continue to thoughtfully build out our portfolio. And with that, I'd like to now turn the call over to Paul to provide an operational update. Thank you, Brian . I'm excited to share details on another remarkable quarter.

Paul Blanchfield: And with that, I'd like to now turn the call over to Paul to provide an operational update. Thank you, Brian. I'm excited to share details on another remarkable quarter. Polarify generated net sales of more than $273 million, up nearly 30 percent from the prior year period, driven by continued PSMA-PET diagnostic growth and sustained preference for Polarify as the number one utilized PSMA-PET imaging agent and the clear standard for patients and healthcare providers. Existing accounts continue to grow as our sales and marketing efforts, including our Let's Be Clear campaign, generate awareness and ultimately demand for Polarify among strategic accounts and referring physicians.

Paul M. Blanchfield: I'm excited to share details on another remarkable quarter. Polarify generated net sales of more than $273 million, up nearly 30% from the prior year period, driven by continued PSMA PET diagnostic growth and sustained preference for Polarify as the number one utilized PSMA PET imaging agent and the clear standard for patients and health care providers. Existing accounts continue to grow as our sales and marketing efforts, including our Let's Be Clear campaign, generate awareness and ultimately demand for Polarify among strategic accounts and referring physicians.

Paul: Polarify generated net sales of more than $273 million, up nearly 30% from the prior year period.

Paul: Driven by continued PSMA PET diagnostic growth and sustained preference for Polarify as the number one utilized PSMA PET imaging agent and the clear standard for patients and health care providers.

Paul: Existing accounts continue to grow as our sales and marketing efforts, including our Let's Be Clear campaign, generate awareness and ultimately demand for Polarify among strategic accounts and referring positions.

Paul Blanchfield: Polarify remains the only PSMA-PET imaging agent that is widely available through a diverse F-18 distributor network that we continue to enhance, ensuring convenient and reliable supply. Polarify has now been administered in all 48 contiguous states, as well as Washington, D.C., Puerto Rico, and outside of the U.S. throughout European partners. Earlier this month, CMS released the calendar year 2025 proposed Hospital Outpatient Prospective Payment System, or OPPS, rule, which recognizes the value and need for broad access to diagnostic radiopharmaceuticals, including Polarify. The rule proposes separate payment for diagnostic radiopharmaceuticals with per day cost greater than $630 following the expiry of transitional pass-through payment or TPPT.

Paul M. Blanchfield: Polarify remains the only PSMA PET imaging agent that is widely available through a diverse F-18 distributor network that we continue to enhance, ensuring convenient and reliable supply. Polarify has now been administered in all 48 contiguous states, as well as Washington, D.C., Puerto Rico, and outside of the U.S. through our European partners. Earlier this month, CMS released the calendar year 2025 Proposed Hospital Outpatient Prospective Payment System, or OPPS rule, which recognizes the value and need for broad access to diagnostic radiopharmaceuticals, including Polarify. The rule proposes separate payment for diagnostic radiopharmaceuticals with per day costs greater than $630 following the expiry of transitional pass-through payment, or TPT.

Paul: Polarify remains the only PSMA PET imaging agent that is widely available through a diverse F-18 distributor network that we continue to enhance, ensuring convenient and reliable supply.

Paul: Polarify has now been administered in all 48 contiguous states as well as Washington DC, Puerto Rico, and outside of the U.S. through our European partnership.

Paul M. Blanchfield: This represents significant progress for the field of diagnostic radiopharmaceuticals and, most importantly, sustained patient access. If implemented as a final rule in November, CMS would maintain separate payment for Polarify for the approximately 20 percent of patients with traditional Medicare fee-for-service insurance coverage who are treated in the hospital outpatient setting, in addition to the PET-CT procedural payment. In the proposed rule, separate payment would be based on mean unit cost, or MUC, beginning in 2025, and potentially transition to ASP at a future date once manufacturers have an opportunity to submit, certify, or restate relevant ASPs. CMS outlined its proposed payment rates, including Polarify, in Addendum B of the proposed rule. As we are in the midst of a 60-day comment period, we want to limit speculation on this topic.

Paul: Earlier this month, CMS released the Calendar Year 2025 Proposed Hospital Outpatient Prospective Payment System, or OPPS, rule.

Paul: which recognizes the value and need for broad access to diagnostic radiopharmaceuticals, including Polarify.

Paul: The rule proposes separate payment for diagnostic radiopharmaceuticals with per-day costs greater than $630 following the expiry of transitional pass-through payment, or TPT.

Paul Blanchfield: This represents significant progress for the field of diagnostic radiopharmaceuticals and, most importantly, sustained patient access. If implemented as a final rule in November, CMS would maintain separate payment for Polarify for the approximately 20% of patients with traditional Medicare fee-for-service insurance coverage who are treated in the hospital outpatient setting, in addition to the PETCT procedural payment. In the proposed rule, separate payment would be based on mean unit cost or MUC, beginning in 2025, and potentially transition to ASP at a future date once manufacturers have an opportunity to submit, certify, or restate relevant ASPs. CMS outlined its proposed payment rates, including Polarify, in a Dendom B of the proposed rules.

Paul: This represents significant progress for the field of diagnostic radiopharmaceuticals and most importantly, sustained patient access.

Paul: if implemented as a final rule in November .

Paul: CMS would maintain separate payment for Polarify for the approximately 20% of patients with traditional Medicare fee-for-service insurance coverage who are treated in the hospital outpatient setting in addition to the PET-CT procedural payment.

Paul: In the proposed rule, separate payment would be based on mean unit cost, or MUC, beginning in 2025, and potentially transition to ASP at a future date once manufacturers have an opportunity to submit, certify, or restate relevant ASPs.

Paul: CMS outlined its proposed payment rates, including Polarify, in Addendum B of the proposed rules.

Paul Blanchfield: As we are in the midst of a 60-day comment period, we want to limit speculation on this topic. Naturally, we will continue to work with industry stakeholders and CMS to maximize patient access and look forward to updating you further when we see the final rule in November. In parallel to CMS's proposed rule, we will continue to support the passage of legislation to codify separate payment for innovative diagnostic radiopharmaceuticals. CMS's proposal represents significant progress, and we will continue to implement our multifaceted strategy to sustain broad patient access to Polarify. This entails differentiating Polarify clinically and commercially through our educational and promotional efforts, and entering into long-term strategic partnerships with our key customers.

Speaker Change: As we are in the midst of a 60-day comment period, we want to limit speculation on this topic. Naturally, we will continue to work with industry stakeholders and CMS to maximize patient access and look forward to updating you further when we see the final rule in November .

Paul M. Blanchfield: Naturally, we will continue to work with industry stakeholders and CMS to maximize patient access and look forward to updating you further when we see the final rule in November. In parallel to CMS's proposed rule, we will continue to support the passage of legislation to codify separate payment for innovative diagnostic radiopharmaceuticals. CMS's proposal represents significant progress, and we will continue to implement our multifaceted strategy to sustain broad patient access to Polarify. This entails differentiating Polarify clinically and commercially through our educational and promotional efforts and entering into long-term strategic partnerships with our key customers.

Speaker Change: In parallel to CMS's proposed rule, we will continue to support the passage of legislation to codify separate payment for innovative diagnostic radiopharmaceuticals.

Speaker Change: CMS's proposal represents significant progress, and we will continue to implement our multifaceted strategy to sustain broad patient access to Polarify.

Speaker Change: This entails differentiating Polarify clinically and commercially through our educational and promotional efforts and entering into long-term strategic partnerships with our key customers.

Paul Blanchfield: These efforts will further solidify Polarify leadership and support growth in 2025 and beyond. Polarify has seen significant adoption since its launch, and we expect the current addressable market to grow from over $2 billion in 2024 to north of $3 billion by 2029. In addition, PSMAPET scans still only represent approximately 30 percent of prostate cancer scans, with conventional imaging such as bone scans, MRI, and CT making up 70 percent of prostate cancer scan volume. Clearly, there remains significant near- and long-term opportunity for PSMAPET, and Polarify is well positioned to be the first blockbuster radiopharmaceutical diagnostic. We are pleased with our progress and remain fiercely committed to conveying Polarify's clinical and commercial differentiation to expand the overall market and solidify Polarify's clear leader.

Paul M. Blanchfield: These efforts will further solidify Polarified's leadership and support growth in 2025 and beyond. Polarify has seen significant adoption since its launch, and we expect the current addressable market to grow from over $2 billion in 2024 to north of $3 billion by 2029. In addition, PSMA PET scans still only represent approximately 30% of prostate cancer scans, with conventional imaging such as bone scans, MRI, and CT making up 70% of prostate cancer scan volume.

Speaker Change: These efforts will further solidify Polarified's leadership and support growth in 2025 and beyond.

Speaker Change: Polarify has seen significant adoption since its launch, and we expect the current addressable market to grow from over $2 billion in 2024 to north of $3 billion by 2029.

Speaker Change: In addition, PSMA PET scans still only represent approximately 30% of prostate cancer scans, with conventional imaging, such as bone scans, MRI, and CT, making up 70% of prostate cancer scan volume.

Paul M. Blanchfield: Clearly, there remains significant near and long-term opportunity for PSMA PET, and Polarify is well-positioned to be the first blockbuster radiopharmaceutical diagnosis. We are pleased with our progress and remain fiercely committed to communicating Polarify's clinical and commercial differentiation to expand the overall market and solidify Polarify's clear leadership. Dfinity continued its strong momentum with second quarter net sales of approximately $78 million, up almost 11% year over year.

Speaker Change: Clearly, there remains significant near and long-term opportunity for PSMA PET, and Polarify is well positioned to be the first blockbuster radiopharmaceutical diagnostic.

Speaker Change: We are pleased with our progress and remain fiercely committed to conveying Polarify's clinical and commercial differentiation to expand the overall market and solidify Polarify's clear leadership.

Paul Blanchfield: Definity continued its strong momentum, with second quarter net sales of approximately $78 million, up almost 11% year-over-year. Definity's drivers of success continued to be its clinical and commercial value proposition, decades of experience in clinical use, and our cardiology franchise's focus on operational excellence. With our expanding pipeline, including the three transactions Brian noted, we continue to build out our R&D team and capabilities. As announced in May, our new chief medical officer, Dr. Jeff Humphrey, brings tremendous oncology and neurology, drug development expertise, and his leadership and expertise has already, and will continue to help advance our pipeline.

Speaker Change: DFINITY continued its strong momentum, with second quarter net sales of approximately $78 million, up almost 11% year over year.

Paul M. Blanchfield: DFINITY's drivers of success continue to be its clinical and commercial value proposition. Decades of experience in clinical use, and our cardiology franchises focus on operational excellence. With our expanding pipeline, including the three transactions Brian noted, we continue to build out our R&D team and capabilities. As announced in May, our new Chief Medical Officer, Dr. Jeff Humphrey, brings tremendous oncology and neurology drug development expertise, and his leadership and expertise have already helped advance our pipeline. Within our prostate cancer portfolio, PNT2002 is our investigational PSMA-targeted radioligand therapy for the treatment of patients with metastatic castration-resistant prostate cancer.

Speaker Change: DFINITY's drivers of success continue to be its clinical and commercial value proposition, decades of experience in clinical use, and our cardiology franchise's focus on operational excellence.

Speaker Change: With our expanding pipeline, including the three transactions Brian noted, we continue to build out our R&D team and capabilities.

Speaker Change: As announced in May, our new Chief Medical Officer, Dr. Jeff Humphrey, brings tremendous oncology and neurology drug development expertise, and his leadership and expertise has already and will continue to help advance our pipeline.

Paul Blanchfield: Within our profit cancer portfolio, P&T2002 is our investigational PSMA-targeted radio ligand therapy for the treatment of patients with metastatic castration-resistant prostate cancer. In December 2023, we reported that Splash, the Phase III registrational study, achieved its primary endpoint with a statistically significant 29% reduction in the risk of radiographic progression or death. In the coming weeks, we expect to have reached approximately 75% of protocol-specified OS events and plan to share more mature overall survival data in the third quarter. Additionally, we are pleased that the FDA accepted our abbreviated new drug application for P&T2003, a product candidate for the treatment of neuroendocrine tumors.

Speaker Change: Within our prostate cancer portfolio, PNT2002 is our investigational PSMA-targeted radioligand therapy for the treatment of patients with metastatic castration-resistant prostate cancer.

Paul M. Blanchfield: In December 2023, we reported that SPLASH, the Phase 3 Registrational Study, achieved its primary endpoint with a statistically significant 29% reduction in the risk of radiographic progression or death. In the coming weeks, we expect to have reached approximately 75 percent of protocol-specified OS events and plan to share more mature overall survival data in the third quarter. Additionally, we are pleased that the FDA accepted our abbreviated new drug application for PNT2003, a product candidate for the treatment of neuroendocrine tumors.

Speaker Change: In December 2023, we reported that SPLASH, the Phase 3 Registrational Study, achieved its primary endpoint with a statistically significant 29% reduction in the risk of radiographic progression or death.

Speaker Change: In the coming weeks, we expect to have reached approximately 75% of protocol-specified OS events and plan to share more mature overall survival data in the third quarter.

Speaker Change: Additionally, we are pleased that the FDA accepted our abbreviated new drug application for PNT2003, a product candidate for the treatment of neuroendocrine tumors.

Paul Blanchfield: If approved and pending positive resolution of the Hats-Waxman litigation, P&T2003 could launch in 2026, making it the first radio equivalent to Luticium Dota tape. As Brian mentioned, the acquisition of NAV4694 expands our Alzheimer's diagnostics pipeline. With NAV4694 and MK624, we have two unique diagnostic candidates to aid in addressing the tremendous unmet need among Alzheimer's patients. The FDA's recent approval of another Amaloid Beta-directed antibody includes in the dosage and administration section of the label the need to confirm the presence of Amaloid Beta pathology prior to initiating treatment. We view this as a positive for the future of pet imaging for Alzheimer's disease.

Paul M. Blanchfield: If approved, and pending positive resolution of the Hatch-Waxman litigation, PNT2003 could launch in 2026, making it the first radio equivalent to Lutetium-Dodotane. As Brian mentioned, the acquisition of NAV4694 expands our Alzheimer's diagnostics pipeline. With NAV 4694 and MK 6240, we have two unique diagnostic candidates to aid in addressing the tremendous unmet need among Alzheimer's patients

Speaker Change: If approved, and pending positive resolution of the Hatch-Waxman litigation, PNT2003 could launch in 2026, making it the first radio equivalent to lutetium dotatate.

Speaker Change: As Brian mentioned, the acquisition of NAV4694 expands our Alzheimer's Diagnostics Pipeline.

Brian: With NAV 4694 and MK 6240, we have two unique diagnostic candidates to aid in addressing the tremendous unmet need among Alzheimer's patients.

Paul M. Blanchfield: The FDA's recent approval of another amyloid beta-directed antibody includes, in the dosage and administration section of the label, the need to confirm the presence of amyloid beta pathology prior to initiating treatment. We view this as positive for the future of pet imaging for Alzheimer's. Also last month, the National Institute on Aging and the Alzheimer's Association published revised criteria for the diagnosis and staging of Alzheimer's. One of the guidelines' main principles is that Alzheimer's disease should be defined biologically using protein-based biomarkers and not only based on a clinical assessment. These guidelines recommend that biomarkers, including both amyloid and tau PET imaging, may be used to diagnose Alzheimer's disease and provide an indication of its severity.

Speaker Change: The FDA's recent approval of another amyloid beta-directed antibody includes, in the Dosage and Administration section of the label, the need to confirm the presence of amyloid beta pathology prior to initiating treatment.

Paul Blanchfield: Also last month, the National Institute on Aging and the Alzheimer's Association published revised criteria for the diagnosis and staging of Alzheimer's disease. One of the guidelines' main principles is that Alzheimer's disease should be defined biologically using protein-based biomarkers and not only based on a clinical assessment. These guidelines recommend that biomarkers, including both Amaloid and Talpet imaging, may be used to diagnose Alzheimer's disease and provide an indication of its severity. We are excited at the prospect of aiding in the diagnosis, staging, and monitoring of Alzheimer's disease. We held a pre-NDA meeting with the FDA, and we expect to submit an NDA for MK62420 in 2025.

Speaker Change: We view this as a positive for the future of pet imaging for Alzheimer's disease.

Speaker Change: Also last month, the National Institute on Aging and the Alzheimer's Association published revised criteria for the diagnosis and staging of Alzheimer's disease.

Speaker Change: One of the guidelines' main principle is that Alzheimer's disease should be defined biologically, using protein-based biomarkers, and not only based on a clinical assessment.

Speaker Change: These guidelines recommend that biomarkers, including both amyloid and tau PET imaging, may be used to diagnose Alzheimer's disease and provide an indication of its severity.

Robert J. Marshall: We are excited at the prospect of aiding in the diagnosis, staging, and monitoring of Alzheimer's. Recently, we held a pre-NDA meeting with the FDA, and we expect to submit an NDA for MK-6240 in 2025. We look forward to sharing more about the regulatory pathways and timelines for MK6240 and NAV4694 in the future. I will now turn the call over to Bob. Thank you, Paul, and good morning,

Speaker Change: We are excited at the prospect of aiding in the diagnosis, staging, and monitoring of Alzheimer's disease.

Speaker Change: Recently, we held a pre-NDA meeting with the FDA, and we expect to submit an NDA for MK-6240 in 2025.

Paul Blanchfield: We look forward to sharing more about the regulatory pathways and timelines for MK62420 and now 4694 in the future.

Speaker Change: We look forward to sharing more about the regulatory pathways and timelines for MK6240 and NAV4694 in the future.

Bob Marshall: I will now turn the call over to Bob. Thank you, Paul, and good morning, everyone. I will provide highlights of the second quarter, 2024 financials focusing on adjusted results with comparisons to the prior year quarter unless otherwise noted. During the details, consolidated net revenue for the second quarter was $394.1 million, an increase of 22.5%. Radio pharmaceutical oncology contributed 273.3 million of sales, up 29.3%, a trivial entirely to the continued strength of polarifi and generally in line with expectations and seasonal trends we've noted over the last year. Precision diagnostic revenue of 112.1 million was 14.9% higher.

Robert J. Marshall: I will provide highlights of the second quarter 2024 financials, focusing on adjusted results with comparisons to the prior year quarter, unless otherwise noted. Turning to the details, consolidated net revenue for the second quarter was $394.1 million, an increase of 22.5%. Radiopharmaceutical Oncology contributed $273.3 million in sales, up 29.3%, attributable entirely to the continued strength of Polarify and generally in line with expectations and seasonal trends we've noted over the last year. Precision Diagnostics revenue of $112.1 million was 14.9% higher.

Speaker Change: I will now turn the call over to Bob. Thank you, Paul, and good morning, everyone. I will provide highlights of the second quarter 2024 financials, focusing on adjusted results with comparisons to the prior year quarter, unless otherwise noted.

Robert J. Marshall: Highlights include sales of DFINITY at $78.1 million, 10.7% higher, along with Technolite revenue of $28.2 million, up 30.5% due to opportunistic sales in the quarter. Lastly, strategic partnerships and other revenue was $8.7 million, down 31.7% due to the prior year comparable having $7 million of RellaStore-related royalties not repeated this year, offset by a strong MK-6240 contribution. Gross profit margin for the second quarter was 68.4%, a decrease of 121 basis points from the second quarter of 2023, due largely to an approximate 80 basis point headwind due to the previously noted Relestore royalty sale mid last year.

Bob: Turning to the details, consolidated net revenue for the second quarter was $394.1 million, an increase of 22.5%.

Speaker Change: Radiopharmaceutical Oncology contributed $273.3 million of sales, up 29.3%, attributable entirely to the continued strength of Polarify, and generally in line with expectations and seasonal trends we've noted over the last year.

Speaker Change: Precision Diagnostic Revenue of $112.1 million was 14.9% higher.

Bob Marshall: Highlights include sales of Affinity at 78.1 million, 10.7% higher, along with Technolite revenue of 28.2 million, up 30.5% due to opportunistic sales in the quarter. Lastly, strategic partnerships and other revenue was $8.7 million, down 31.7%, due to the prior year comparable having $7 million of relist or related royalties not repeated this year, offset by a strong MK6242 contribution. Gross profit margin for the second quarter was 68.4%, a decrease of 121 basis points from the second quarter of 2023, due largely to an approximate 80 basis point headwind due to the previously noted relist or royalty sale mid last year.

Speaker Change: Highlights include sales of DFINITY at $78.1 million.

Speaker Change: 10.7% higher, along with TechnoLite revenue of $28.2 million, up 30.5% due to opportunity sales in the quarter.

Speaker Change: Lastly, strategic partnerships and other revenue was $8.7 million, down 31.7% due to the prior year comparable having $7 million of RellaStore-related royalties not repeated this year, offset by a strong MK-6240 contribution.

Speaker Change: Gross profit margin for the second quarter was 68.4%, a decrease of 121 basis points from the second quarter of 2023, due largely to an approximate 80 basis point headwind due to the previously noted Relastore royalty sale mid last year.

Bob Marshall: Further, benefits from favorable overall product mix led by robust volumes of polarifying affinity were offset by higher than forecasted technolite volumes, all amidst higher contracted material and overhead costs, as well as expenses tied to the polarify lifecycle management and PMF network expansion. Operating expenses at 25% of net revenue were 202 basis points higher than the prior year rate and head of expected spending levels. The company continues to invest in the Polarify franchise as well as development of our clinical pipeline. R&D expenses increase in the quarter, notably to advance MK6242, as well as business development evaluations not previously forecasted across multiple functions.

Robert J. Marshall: Further, benefits from a favorable overall product mix, led by robust volumes of polarizing affinity, were offset by higher-than-forecasted technolite volumes, all amidst higher contracted material and overhead costs, as well as expenses tied to Polarified Lifecycle Management and PMF network expansion. Operating expenses at 25% of net revenue were 202 basis points higher than the prior year rate and ahead of the expected spending level. The company continues to invest in the Plurify franchise as well as the development of our clinical pipeline. R&D expenses increased in the quarter, notably to advance MK-6240, as well as business development evaluations not previously forecasted across multiple funds. Operating profit for the quarter was $171 million, or an increase of 14%.

Speaker Change: Further, benefits from favorable overall product mix, led by robust volumes of polarifying affinity, were offset by higher-than-forecasted technolite volumes, all amidst higher contracted material and overhead costs, as well as expenses tied to Polarified Lifecycle Management and PMF network expansion.

Speaker Change: Operating expenses at 25% of net revenue were 202 basis points higher than the prior year rate and ahead of expected spending levels. The company continues to invest in the Plurify franchise as well as development of our clinical pipeline.

Speaker Change: R&D expenses increased in the quarter, notably to advance MK-6240, as well as business development evaluations not previously forecasted across multiple functions.

Bob Marshall: Operating profit for the quarter was 171 million, or an increase of 14%. Other income and expense at 4.2 million of income is the result of net interest income offset in part by interest expense in our existing debt. Total adjustments for the quarter were 90.9 million of expense before taxes. Of this amount, 18.5 and 10.1 million of expense is associated with non-cash stock and incentive plans and acquired intangible amortization, respectively. 38.3 million of IPR&D and transactional expenses relate to the deals announced in the quarter, along with 22.5 million of unrealized loss tied to our equity investment and perspective.

Speaker Change: Operating profit for the quarter was $171 million, or an increase of 14%. Other income and expense at $4.2 million of income is a result of net interest income offset in part by interest expense in our existing debt.

Robert J. Marshall: Other income and expense, at $4.2 million of income, is a result of net interest income offset in part by interest expense in our existing. Total adjustments for the quarter were $90.9 million of expense before taxes. Of this amount, $18.5 and $10.1 million of expense are associated with non-cash stock and incentive plans and acquired intangible amortization, respectively. 38.3 million of IP R&D and Transactional Expenses relate to the deals announced in the quarter, along with $22.5 million of unrealized losses tied to our equity investment in perspective, with the remainder relating to acquisition, integration, and other non-recurring.

Speaker Change: Total adjustments for the quarter were $90.9 million of expense before taxes. Of this amount, $18.5 and $10.1 million of expense is associated with non-cash stock and incentive plans and acquired intangible amortization, respectively.

Speaker Change: 38.3 million of IP R&D

Speaker Change: and Transactional Expenses relate to the deals announced in the quarter, along with $22.5 million of unrealized loss tied to our equity investment in perspective, with the remainder relating to acquisition, integration, and other non-recurring expenses.

Bob Marshall: We're the remainder relating to acquisition integration and other non-recurring. Our effective tax rate was 27.6%; the resulting reported net income for the second quarter was 62.1 million and 126.8 million on an adjusted basis, an increase of 15.7%. $117 million over Q2 last year when we paid the Polarify CVRs. Capital expenditures totaled $11.2 million, essentially flat with the prior year. Free cash flow, which we defined as operating cash flow less capital expenditures, was $73.5 million, an increase of $116.5 million over the prior year. During the quarter, the company invested $32.9 million to acquire now $46.94. It is worth noting that the other transactions we've announced in recent weeks were funded in July and are not reflected in the use of cash in the Q2 financials.

Robert J. Marshall: Our effective tax rate was 27.6%; the resulting reported net income for the second quarter was $62.1 million and $126.8 million on an adjusted basis, an increase of 15.7%. Gap fully diluted earnings per share for the second quarter were 88 cents and $1.80 on an adjusted basis, an increase of 16.4%.

Speaker Change: Our effective tax rate was 27.6%, the resulting reported net income for the second quarter was $62.1 million and $126.8 million on an adjusted basis, an increase of 15.7%.

Speaker Change: Gap fully diluted earnings per share for the second quarter were $0.88 and $1.80 on an adjusted basis, an increase of 16.4%.

Robert J. Marshall: Now turning to cash flow, second quarter operating cash flow totaled $84.7 million, $117 million over Q2 last year when we paid the Polarify CVR. Capital expenditures totaled $11.2 million, essentially flat with the prior year. Free cash flow, which we defined as operating cash flow less capital expenditures, was $73.5 million, an increase of $116.5 million over the prior year. During the quarter, the company invested $32.9 million to acquire NAV4694. It is worth noting that the other transactions we've announced in recent weeks were funded in July and are not reflected in the use of cash in the Q2 financial statements.

Speaker Change: Now turning to cash flow, second quarter operating cash flow totaled $84.7 million, $117 million over Q2 last year when we paid the Polarify CVRs.

Speaker Change: Capital expenditures totaled $11.2 million, essentially flat with the prior year. Free cash flow, which we defined as operating cash flow less capital expenditures, was $73.5 million, an increase of $116.5 million over the prior year.

Speaker Change: During the quarter, the company invested $32.9 million to acquire NAV4694. It is worth noting that the other transactions we've announced in recent weeks were funded in July and are not reflected in the use of cash in the Q2 financials.

Robert J. Marshall: Taken together, cash and cash equivalents, net of restricted cash, now stand at $757 million. We have access to our $350 million undrawn bank revolver and are comfortable with our strong liquidity position. Now turning to our updated guidance for the full year 2024, as well as some details for the second half of the year, notably adjusted EPA. We are affirming our view of revenue for the full year and the previously implied second half of the year, drawing particular attention to the seasonal patterns between Q3 and Q4, as we have continuously noted.

Bob Marshall: Taken together, cash and cash equivalents, net restricted cash, now stand at $757 million. We have access to our $350 million undrawn bank revolver and are comfortable with our strong liquidity position.

Speaker Change: Taken together, cash and cash equivalents, net of restricted cash, now stand at $757 million. We have access to our $350 million undrawn bank revolver and are comfortable with our strong liquidity position.

Bob Marshall: Now turning to our updated guidance for the full year 2024, as well as some details for the second half of the year, notably adjusted EPS. We are affirming our view of revenue for the full year in the previously implied second half of the year, drawing particular attention to the seasonal patterns between Q3 and Q4, as we have continuously noted. As a reminder, we estimate full year consolidated revenue to be in a range of 1.5 to 1.52 billion, with Polarify expected to grow mid 20%. With regard to Polarify, we expect the Q3, Q4 revenue split to favor Q4 on an absolute dollar basis, driven by fewer patient visits during the summer months, as we have seen traditionally.

Speaker Change: Now turning to our updated guidance for the full year 2024, as well as some details for the second half of the year, notably adjusted EPS.

Speaker Change: We are affirming our view of revenue for the full year and the previously implied second half of the year, drawing particular attention to the seasonal patterns between Q3 and Q4, as we have continuously noted.

Robert J. Marshall: As a reminder, we estimate full-year consolidated revenue to be in a range of $1.5 to $1.52 billion, with Polarify expected to grow mid-20%. With regard to Polarify, we expect the Q3-Q4 revenue split to favor Q4 on an absolute dollar basis, driven by fewer patient visits during the summer months, as we have seen traditionally.

Speaker Change: As a reminder, we estimate full-year consolidated revenue to be in a range of $1.5 to $1.52 billion, with Polarify expected to grow mid-20%.

Speaker Change: With regard to Polarify, we expect the Q3-Q4 revenue split to favor Q4 on an absolute dollar basis.

Bob Marshall: Volumes continue to grow throughout, offset by the impact on net revenue from our strategic partnerships with key customers, which will begin to manifest more fully as we go deeper into the year. Our prior adjusted EPS guidance of $7 to $7.20 naturally did not take into account the investments we subsequently made to support our long-term future growth as well as the dynamics of our capital structure. Therefore, we are adjusting our view of earnings to account for the cumulative effect of these transactions we've announced over the last several weeks, and in anticipation of now filing an NDA for MK6242 in 2025.

Robert J. Marshall: Volumes will continue to grow throughout the year, offset by the impact on net revenue from our strategic partnerships with key customers, which will begin to manifest more fully as we go deeper into the year. Our prior adjusted EPS guidance of $7 to $7.20 naturally did not take into account the investments we subsequently made to support our long-term future growth, as well as the dynamics of our capital system. Therefore, we are adjusting our view of earnings to account for the cumulative effect of these transactions we've announced over the last several weeks and in anticipation of now filing an NDA for MK6240 in 2025.

Speaker Change: Driven by fewer patient visits during the summer months as we have seen traditionally.

Speaker Change: Volumes will continue to grow throughout, offset by the impact on net revenue from our strategic partnerships with key customers.

Speaker Change: which will begin to manifest more fully as we go deeper into the year.

Speaker Change: Our prior adjusted EPS guidance of $7 to $7.20 naturally did not take into account the investments we subsequently made to support our long-term future growth, as well as the dynamics of our capital structure.

Speaker Change: Therefore, we are adjusting our view of earnings to account for the cumulative effect of these transactions we've announced over the last several weeks, and in anticipation of now filing an NDA for MK-6240 in 2025.

Bob Marshall: Much of the anticipated investment for 2024, approximately 25 cents, is within the R&D line and will vary on a year-to-year basis as we near commercialization. Additionally, at the current share price and based on calculations tied to our convertible den instrument, you should model fully diluted weighted average shares outstanding for the second half of the year to be approximately 74 and a half million shares and about 72 and a half million for the full year. Therefore, fully diluted adjusted earnings per share should be in a range of $6.60 to $6.70. As has been the case all year, this estimate does not include any incremental investment for PNT2002, nor any further business development that might be completed this year.

Robert J. Marshall: Much of the anticipated investment for 2024, approximately $0.25, is within the R&D line and will vary on a year-to-year basis as we near commercialization. Additionally, at the current share price and based on calculations tied to our convertible debt instrument, you should model fully diluted weighted average shares outstanding for the second half of the year to be approximately 74.5 million shares and about 72.5 million for the full year. Therefore, fully diluted adjusted earnings per share should be in a range of $6.60 to $6.70.

Speaker Change: Much of the anticipated investment for 2024, approximately $0.25, is within the R&D line and will vary on a year-to-year basis as we near commercialization.

Speaker Change: Additionally, at the current share price and based on calculations tied to our convertible debt instrument.

Speaker Change: You should model fully diluted weighted average shares outstanding for the second half of the year to be approximately 74.5 million shares and about 72.5 million shares.

Speaker Change: for the full year. Therefore, fully diluted adjusted earnings per share should be in a range of $6.60 to $6.70.

Brian A. Markison: As has been the case all year, this estimate does not include any incremental investment for PNT2002 nor any further business development that might be completed this year. Lastly, you'll note that we steered away from quarterly guidance to reflect our focus on solid near-term decisions to deliver longer-term growth. In the future, we will offer full-year guidance and sufficient color for the investment community to track our progress throughout the year. With that, I will turn the call back over to Brian.

Speaker Change: As has been the case all year, this estimate does not include any incremental investment for PNT2002, nor any further business development that might be completed this year.

Bob Marshall: Lastly, you'll note that we've steered away from quarterly guidance to reflect our focus on solid near-term decisions to deliver longer-term growth. In the future, we will offer full-year guidance and sufficient color for the investment community to track our progress throughout the year.

Speaker Change: Lastly, you'll note that we steered away from quarterly guidance to reflect our

Speaker Change: focus on solid near-term decisions to deliver longer-term growth. In the future, we will offer full-year guidance and sufficient color for the investment community to track our progress throughout the year. With that, let me turn the call back over to Brian .

Brian Markison: With that, let me turn the call back over to Brian. Thank you, Bob. With Polarify on track to surpass $1 billion in sales and be the first radiopharmaceutical diagnostic blockbuster, and definitively maintaining 80-plus percent market share, Lantheus continues to maximize the value of our commercial portfolio. As demonstrated through our three strategic transactions in the second quarter, and the progress of our current product candidates, we are fully committed to advancing and expanding our pipeline. We will continue to focus on radio diagnostics and radio therapeutics that can make a difference for significant patient populations. Lastly, we will continue to sustain an attractive financial profile by delivering strong performance for our commercial portfolio and deploying our long-standing radio-pharmaceutical expertise and capital resources to invest in and bolster our pipeline through strategic business development.

Brian A. Markison: Thank you, Bob. With Polarify on track to surpass $1 billion in sales and be the first radiopharmaceutical diagnostic blockbuster, and DFINITY maintaining 80 plus percent market share, Lantheus continues to maximize the value of our commercial portfolio. As demonstrated through our three strategic transactions in the second quarter and the progress of our current product candidates, we are fully committed to advancing and expanding our pipeline. We will continue to focus on radiodiagnostics and radiotherapeutics that can make a difference for significant patient populations.

Brian: Thank you Bob. With Polarify on track to surpass $1 billion in sales and be the first radiopharmaceutical diagnostic blockbuster,

Speaker Change: and DFINITY maintaining 80 plus percent market share, Lantheus continues to maximize the value of our commercial portfolio.

Speaker Change: As demonstrated through our three strategic transactions in the second quarter and the progress of our current product candidates, we are fully committed to advancing and expanding our pipeline.

Speaker Change: We will continue to focus on radiodiagnostics and radiotherapeutics that can make a difference for significant patient populations.

Operator: Lastly, we will continue to sustain an attractive financial profile by delivering strong performance for our commercial portfolio and deploying our long-standing radiopharmaceutical expertise and capital resources to invest in and bolster our pipeline through strategic business development. In closing, we will continue to advance innovation and realize our purpose to find, fight, and follow disease to deliver better patient outcomes as the leading radiopharmaceutical-focused company. And with that, we are now ready to take your questions. Operator, please go ahead. 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 Change: Lastly...

Speaker Change: We will continue to sustain an attractive financial profile by delivering strong performance for our commercial portfolio and deploying our long-standing radiopharmaceutical expertise and capital resources

Speaker Change: to invest in and bolster our pipeline through strategic business development.

Brian Markison: In closing, we will continue to advance innovation and realize our purpose to find, fight, and follow disease to deliver better patient outcomes as the leading radio-pharmaceutical focus company.

Speaker Change: In closing, we will continue to advance innovation and realize our purpose to find, fight, and follow disease to deliver better patient outcomes as the leading radiopharmaceutical-focused company.

Operator: And with that, we are now ready to take your questions. Operator, please go ahead. 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. We ask that you please limit yourself to one question. You may re-enter the queue for further questions. Please stand by. Will we compile the Q&A roster?

Anthony Charles Petrone: We ask that you please limit yourselves to one question. You may re-enter the queue for further questions. Please stand by while we compile the Q&A roster. Our first question comes from the line of Anthony Petrone from Mizuho Group. Thank you, and congratulations on the quarter here. Maybe two questions for me.

Speaker Change: And with that, we are now ready to take your questions. Operator, please go ahead.

Speaker Change: Thank you. As a reminder to ask a question please press star 1 1 on your telephone and wait for your name to be announced.

Speaker Change: To withdraw your question, please press star 11 again. We ask that you please limit yourselves to one question. You may re-enter the queue for further questions.

Speaker Change: Please stand by while we compile the Q&A roster.

Anthony Patrone: Our first question comes from the line of Anthony Patrone from Mizzoujo Group.

Brian A. Markison: One will be on Polarify, and the second will be on the revised earnings guidance. So on Polarify, maybe just to level set, you know, the viewpoints from the company on the CMS recommendation to unbundle. It seems like that certainly was... You know, a positive proposal from CMS. There's a debate on how pricing will settle out once we get into the final ruling period in late October or November. So maybe just to level set, you know, what we've learned in proposal season and the expectations for the final rule for polarized. And then the second question on earnings guidance, clearly a big step up here in R&D. Brian, you called out MK, Bob, and Brian. You called out MK 6240.

Speaker Change: Our first question comes from the line of Anthony Petrone from Mizuho Group.

Anthony Patrone: Thank you, and congratulations on the quarter here. Maybe two questions for me. One will be on clarify, and the second will be on the revised earnings guidance. So on clarify, maybe just to level set, you know, the viewpoints from the company on the CMS recommendation to on bundle, it seems like that certainly was, you know, a positive proposal from CMS. There's a debate on, you know, how pricing will settle out once we get into the final ruling period in late October, November. So maybe just to level set, you know, what we've learned in proposal season and the expectations into the final rule for clarify.

Anthony Charles Petrone: Thank you and congratulations on the quarter year.

Anthony Charles Petrone: Maybe two questions for me. One will be on Clarify and the second will be on the revised earnings guidance.

Anthony Charles Petrone: So I want to clarify, maybe just to level set, you know, the viewpoints from the company on the CMS recommendation to unbundle.

Anthony Charles Petrone: It seems like that certainly was.

Anthony Charles Petrone: You know, a positive proposal from CMS.

Anthony Charles Petrone: There's a debate on how pricing will settle out once we get into the final ruling period in late October-November. So maybe just to level set what we've learned in proposal season and the expectations into the final rule for Polarify.

Brian Markison: And then the second question on earnings guidance: clearly a big step up here in R&D. Brian, you called out MK Bob and Brian, you called out MK6240, but also other business development costs in there. I think that perhaps there's also some exposure to the perspective deal in there. So maybe just the moving parts on the step up in R&D. And is this the runway we should be expecting going forward? Thanks. Thank you. Okay, and thanks for the questions. Good morning.

Speaker Change: And then the second question on earnings guidance, clearly a big step up here in R&D.

Brian: Brian , you called out MK, Bob and Brian , you called out MK 6240, but also other business development costs in there. I think there perhaps is also some exposure to the perspective.

Brian: deal in there. So maybe just the moving parts on the step up in R&D, and is this the runway we should be expecting going forward? Thank you.

Brian A. Markison: But also other business development costs are in there. I think there perhaps is also some exposure to the perspective deal in there. So maybe just the moving parts on the step up in R&D. And is this the runway we should be expecting going forward? Thank you. Okay, and thanks for the questions. Good morning.

Brian A. Markison: Before Paul launches into... the CMS topic. We are trying to avoid too much speculation here since we're within the comment period. You win the over-under.

Paul Blanchfield: Before Paul launches into the CMS topic, we are trying to avoid too much speculation here since we're within the comment period. So you win the over/under; we're going to answer your question. But for the rest of the folks listening on the line, we will avoid this topic. And then after Paul goes, then Bob will do some clarification on EPS. Paul, if you don't mind. Thanks, Brian. Thanks, Anthony. Good morning. As noted in the prepared remarks, we are pleased that CMS recognizes the value of diagnostic radiopharmaceuticals, including Polarify, and the need to pay separately for diagnostic radiopharmaceuticals.

Speaker Change: Okay, and thanks for the questions. Good morning.

Speaker Change: Before Paul launches into...

Speaker Change: the CMS topic. We are trying to avoid too much speculation here since we're within the comment period so...

Brian A. Markison: We're going to answer your question, but for the rest of the folks listening on the line, we will avoid this topic. And then after Paul goes, Bob will do some clarification on EPS, so Paul, if you don't mind. Thanks, Brian. Thanks, Anthony. Good morning.

Speaker Change: You win the over or under, we're going to answer your question. But for the rest of the folks listening on the line, we will avoid this topic. And then after Paul goes, then Bob will do some clarification on EPS. So Paul, if you don't mind.

Paul M. Blanchfield: As noted in the prepared remarks, we are pleased that CMS recognizes the value of diagnostic radiopharmaceuticals, including Polarify, and the need to pay separately for diagnostic radiopharmaceuticals. If the proposed rule that was put forth becomes final in November, CMS would be maintaining separate payment for Polarify for the 20% of patients that are subject to TPT expiry, namely those with traditional Medicare fee-for-service treated in the hospital outpatient setting. As you noted, the proposed separate payment is based on mean unit cost, or MUC, beginning in 2025 and, as noted in the CMS language, could potentially transition to ASP once manufacturers have an opportunity to submit, certify, or restate relevant ASPs.

Paul: Thanks, Brian . Thanks, Anthony. Good morning. As noted in the prepared remarks, we are pleased that CMS recognizes the value of diagnostic radiopharmaceuticals, including Polarify, and the need to pay separately for diagnostic radiopharmaceuticals.

Paul Blanchfield: If the proposed rule that was put forth becomes final in November, CMS would be maintaining separate payment for Polarify for the 20% of patients that are subject to TPP, namely those with traditional Medicare fee-for-service, treated in the hospital outpatient setting. As you noted, the proposed separate payment is based on mean unit cost or MUC beginning in 2025. And, as noted in the CMS language, could potentially transition to ASP once manufacturers have an opportunity to submit, certify, or restate relevant ASPs. It's important to note that CMS highlighted that they utilize MUC as manufacturers of radiopharmaceutical diagnostics are not required to, and indeed many do not report ASP for radiopharmaceutical diagnostics once off pass-through.

Speaker Change: If the proposed rule that was put forth becomes final in November ,

Speaker Change: CMS would be maintaining separate payment for Polarify for the 20% of patients that are subject to TPT expiry, namely those with traditional Medicare fee-for-service treated in the hospital outpatient setting.

Speaker Change: As you noted, the proposed separate payment is based on mean unit cost, or MUC, beginning in 2025.

Speaker Change: And as noted in the CMS language, could potentially transition to ASP once manufacturers have an opportunity to submit, certify, or restate relevant ASPs.

Paul M. Blanchfield: It's important to note that CMS highlighted that they utilize MUC as manufacturers of radiopharmaceutical diagnostics are not required to, and indeed, many do not report ASP for radiopharmaceutical diagnostics once off pass. Lantheus does, and will continue to submit Polarify ASP to CMS going forward.

Speaker Change: It's important to note that CMS...

Speaker Change: highlighted that they utilize MUC as manufacturers of radiopharmaceutical diagnostics are not required to and indeed many do not report ASP for radiopharmaceutical diagnostics once off pass-through.

Bob Marshall: Lantias does and will continue to submit Polarify ASP to CMS going forward. As Brian noted, we are in the midst of a 60-day comment period, and we're going to continue to work with industry stakeholders and engage with CMS to maximize patient access. Overall, this is significant progress for sustained patient access, and the field of diagnostic radiopharmaceuticals overall, not only Polarify, but also future potential products we have in our pipeline like MK and NAV in Alzheimer's. Thanks. And so Anthony, when you think about the guide, naturally we don't forecast impacts of transactions. And in this case, in addition to that, you know, a significant opportunity to advance MK-6240 for an NDA filing in 2025.

Lampheus: Lantheus does and will continue to submit Polarify ASP to CMS going forward.

Paul M. Blanchfield: As Brian noted, we are in the midst of a 60-day comment period, and we're going to continue to work with industry stakeholders and engage with CMS to maximize patient access. Overall, this is significant progress for sustained patient access and the field of diagnostic radiopharmaceuticals overall, not only Polarify but also future potential products we have in our pipeline, like MK and NAV, in Ohio. Thanks. And so, Anthony, when you think about, you know, the guide, naturally, we don't forecast impacts of transactions.

Lampheus: As Brian noted, we are in the midst of a 60-day comment period, and we're going to continue to work with industry stakeholders and engage with CMS to maximize patient access.

Speaker Change: Overall, this is significant progress for sustained patient access and the field of diagnostic radiopharmaceuticals overall, not only polarified, but also future potential products we have in our pipeline, like MK and NAV in Alzheimer's.

Speaker Change: Thanks. And so, Anthony, when you think about, you know, the guide, naturally we don't forecast impacts of transactions.

Robert J. Marshall: And in this case, in addition to that, you know, a significant opportunity to advance MK6240 for an NDA filing in 2025. As far as what to expect as we go forward, you're right, you outlined it actually in your own question in terms of the 25 percent dilution this year from the number of transactions where we've added a number of really interesting, promising pipeline assets. But as we look forward, obviously, our investment will be commensurate with the opportunity from a commercial perspective.

Speaker Change: And in this case, in addition to that, you know, a significant opportunity to advance MK-6240 for an NDA filing in 2025.

Bob Marshall: As far as what to expect as we go forward, you know, you're right; you outlined it actually in your own question in terms of the 25 cents delusion this year from the number of transactions where we've added a number of really interesting, promising pipeline assets. But as we look forward, obviously, our investment will be commensurate with the opportunity from a commercial perspective. And thinking about commercial, we do expense expenses will vary over time, much like you saw us do with the Polarify opportunity. If I take you back to, you know, late 2020, early 2021, we were investing head of the curve to make sure that we were ready to be able to commercialize that asset and maximize the market opportunity.

Speaker Change: As far as what to expect as we go forward, you're right, you outlined it actually in your own question in terms of the $0.25 dilution this year from the number of transactions where we've added a number of really interesting, promising pipeline assets.

Speaker Change: But as we look forward, obviously our investment will be commensurate with the opportunity from a commercial perspective.

Robert J. Marshall: And thinking about commercial, we do expect that expenses will vary over time, much like you saw us do with the Polarify opportunity. If I take you back to, you know, late 2020, early 2021, we were investing ahead of the curve to make sure that we were ready to be able to commercialize that asset and maximize the market opportunity. And we do those types of investments with an eye towards return on investment, as well as our ability to execute. So, you know, we'll give more color on that as we get, you know, into 20, and we get further into 25 and, obviously, 26 as things progress.

Speaker Change: And thinking about commercial, we do expect that expenses will vary over time, much like you saw us do.

Speaker Change: with the Polarify opportunity. If I take you back to, you know, late 2020, early 2021.

Speaker Change: We were investing ahead of the curve to make sure that we were ready to be able to commercialize that asset and maximize the market opportunity. And we do those types of investments with an eye towards return on investment.

Bob Marshall: And we do those types of investments with an eye towards return on investment as well as our ability to execute. So, you know, we'll give more color on that as we get, you know, into 20, you know, get further into 25 and obviously 26 as the things progress. And we'll make sure that the investment community can build out models and track overall progress. Thank you.

Speaker Change: as well as our ability to execute.

Speaker Change: We'll give more color on that as we get further into 2025 and obviously 2026 as things progress. And we'll make sure that the investment community can build out models and track overall progress.

Robert J. Marshall: And we'll make sure that the investment community can build out models and, you know, track overall progress. Thank you. One moment for our next question. Our next question comes from the line of Roanna Ruiz from Lyrinc Partners. Great morning, everyone.

Operator: One moment for our next question.

Speaker Change: Thank you.

Speaker Change: One moment for our next question.

Roanna Ruiz: Our next question goes from the line of Roanna Ruiz from Learning Partners.

Speaker Change: Our next question comes from the line of Roanna Ruiz from Lyrinc Partners.

Roanna Ruiz: Great, morning everyone. Adding on a question from the first one, I was curious what your thoughts are behind the potential to clarify revenue growth trends when transitioning from two to three Q. And I was also curious how your ongoing strategic contracts with top accounts might be an incremental tailwind going into the second half this year.

Roanna Clarissa H. Ruiz: Adding on a question from the first one, I was curious, what are your thoughts behind the potential Polarify revenue growth trends when transitioning from 2Q to 3Q? And I was also curious how your ongoing strategic contracts with top accounts might be an incremental tailwind going into the second half this year. Good morning. I'll start as Bob, and then I'll turn it over to Paul for the last bit. In terms of seasonal trends, I think, you know, in my prepared remarks, I was trying to be specific about how you would expect Q3 and Q4 with absolute dollar, peak sales, if you will, would be in Q4 versus Q3. So you split it that way.

Roanna Clarissa H. Ruiz: Adding on a question from the first one, I was curious what are your thoughts behind the potential Polarify revenue growth trends when transitioning from 2Q to 3Q? And I was also curious how your ongoing strategic contracts with top accounts might be an incremental tailwind going into second half this year?

Brian Markison: Good morning. I'll start this, Bob, and then I'll turn it over to Paul for the last bit. In terms of seasonal trends, I think, you know, my prepared remark, I was trying to be specific about how you would expect Q3 and Q4 with absolute dollar, you know, peak sales, if you will, would be in Q4 versus Q3. So you split it that way. And that's in line with seasonal trends that we have seen historically, which I think can be broadened, if you will, across more than just Polarify, but broader healthcare. But I did also note that you would expect volumes to continue to grow throughout the year.

Robert J. Marshall: And that's in line with seasonal trends that we have seen historically, which I think can be broadened, if you will, across more than just Polarify but broader healthcare. But I did also note that you would expect volumes to continue to grow throughout the year. And if you were to look at the volume growth, it would be very much in line with our seasonal trends that we've noted, but for more on color, and that'll give it to Paul. Thanks, Bob. Good morning, Roanna.

Roanna Clarissa H. Ruiz: Good morning. I'll start, this is Bob, and then I'll turn it over to Paul for the last bit. In terms of seasonal trends, I think, you know, my prepared remarks, I was trying to be specific about how you would expect

Roanna Clarissa H. Ruiz: Q3 and Q4 with absolute dollar.

Paul: you know, peak sales, if you will, would be in Q4 versus Q3. So you split it that way, and that's in line with seasonal trends that we have seen historically, which I think can be broadened, if you will, across more than just Polarify, but to broader health care.

Paul: But I did also note that you would expect volumes to continue to grow throughout the year. And if you were to look at those volume growths, they would be very much in line with our seasonal trends that we've noted. But for more on color and that, I'll give it to Paul.

Paul Blanchfield: And if you were to look at those volume growth, they would be very much in line with our seasonal trends that we've noted, but for more on color, and that will give it to Paul.

Paul M. Blanchfield: Strategic partnerships, as mentioned in the prepared remarks, remain a core part of our multifaceted strategy to sustain Polarify's clear position as the number one PSMA PET imaging agent. We view these partnerships with key customers as incredibly beneficial to ensure that Polarify remains the PSMA PET agent of choice and accessible to all patients, even amidst three other competitors in the market. Conversations with these key customers continue to go well, and we are pleased with our progress.

Paul Blanchfield: Thanks, Bob. Good morning, Rowana. Strategic partnerships, as mentioned in the prepared remarks, remain a core part of our multi-faceted strategy to sustain Polarify's clear position as the number one PSMA PET imaging agent. We view these partnerships with key customers as incredibly beneficial to ensure that Polarify remains that PSMA PET agent of choice and accessible to all patients, even amidst three other competitors in the market. Conversations with these key customers continue to go well, and we are pleased with our progress. Given the competitive nature of our business, I think you'll understand why we don't necessarily want to elaborate further on the progress or the specificity around these partnerships, but we're pleased with the progress, and we continue to push forward.

Paul: Thanks, Bob. Good morning, Roanna. Strategic partnerships, as mentioned in the prepared remarks, remain a core part of our multifaceted strategy to sustain Polarify's clear position as the number one PSMA PET imaging agent.

Paul: We view these partnerships with key customers as incredibly beneficial to ensure that Polarify remains that PSMA pet agent of choice and accessible to all patients, even amidst three other competitors in the market.

Speaker Change: Conversations with these key customers continue to go well and we are pleased with our progress. Given the competitive nature of our business, I think you'll understand why we don't necessarily want to elaborate further on the progress or the specificity around these partnerships, but we're pleased with the progress and we continue to push forward.

Paul M. Blanchfield: Given the competitive nature of our business, I think you'll understand why we don't necessarily want to elaborate further on the progress or the specificity around these partnerships, but we're pleased with the progress, and we continue to make progress. Thank you.

Operator: Thank you.

Richard Newitter: One moment for our next question.

Richard Newitter: Our next question comes from the line of richer Newwitter from Truest Securities. Hi, thanks for taking the question. I was wondering if you could maybe help us side the Alzheimer's opportunity for you in any way, and it's clearly coming into much newer term or intermediate term focus. How big could this be relative to a market's opportunity, say, like Polarify? And I would imagine the scan per patient component to that is going to be a multiple of what is involved with PSMA PET imaging.

Operator: One moment for our next question. Our next question comes from the line of Richard Newitter from Truist Securities. Hi, thanks for taking the question. I was wondering if you could maybe help us size the Alzheimer's opportunity for you in any way that's clearly coming into much nearer term or intermediate term focus. How big could this be relative to a market opportunity, say like Polarify? And I would imagine the scan per patient.

Speaker Change: Thank you. One moment for our next question.

Speaker Change: Our next question comes from the line of Richard Newitter from Truist Securities.

Richard Samuel Newitter: Hi, thanks for taking the question. I was wondering if you could maybe help us size

Richard Samuel Newitter: The Alzheimer's opportunity for you in any way, that's clearly coming into much nearer term or intermediate term focus. How big could this be relative to a market opportunity, say like Polarify? And I would imagine the scan per patient...

Operator: Unknown Attendee, Brian Dolliver, Yuan Zhi, Lantheus Holdings Inc. It sounds like, you know, even with MUC pricing, you feel better about your bargaining position; you should be in a better bargaining position with the discounting conversations or the contracting conversations you're having than you were prior to the CMS proposal. Is that a fair observation?

Brian Markison: And then, if I could just up front, just piggybacking off the last question, it sounds like even with MBC pricing, you feel better about your bargaining position. You should be in a better bargaining position with the discounting conversations or the contracting conversations you're having. Then you were prior to the CMS proposal. Is that a fair observation? Thanks. Yeah, thanks, Rich. The answer to your last question is no comment, but we're very encouraged by what we're seeing. So it's almost the yes. Anyway, back to the Alzheimer's field, we've quoted before a fairly meaningful tab in excess of a billion.

Speaker Change: component to that is going to be multiple of what is involved in PSMA PET imaging. And then if I could, just up front, just piggybacking off the last question, it sounds like, you know,

Richard Samuel Newitter: Yeah, thanks, Rich. The answer to your last question is: no comment, but we're very encouraged by what we're seeing. So it's almost a yes.

Speaker Change: Yeah, thanks Rich. The answer to your last question is...

Speaker Change: No comment, but we're very encouraged by what we're seeing. So, it's almost a yes.

Brian A. Markison: Anyway, back to the Alzheimer's field. You know, we've quoted before a fairly meaningful TAM in excess of a billion. But I'm not going to get into that.

Speaker Change: Anyway, back to the Alzheimer's field. You know, we've quoted before a fairly meaningful TAM in excess of a billion. I'm not going to get into that. We're placing a bet here and if you look at all the recent innovation

Brian A. Markison: We're placing a bet here. And if you look at all the recent innovation, particularly recent approvals in Alzheimer's therapeutics, this field is about to explode, and, you know, we're at the very beginning of it with, we believe, two agents that are considered next generation or best in class, and we want to be there right, right in front of it. You know, for example, MK6240 is currently in over 90 trials. I believe 83 of them are in academic centers, the top in the country and the world.

Brian Markison: I'm not going to get into that. We're placing a bet here. And if you look at all the recent innovation, particularly recent approvals and Alzheimer's therapeutics, this feels about to explode. And we're at the very beginning of it, with we believe two agents that are considered next generation or best in class. And we want to be there right, right at the front of it. For example, MK624 is currently in over 90 trials. I believe 83 of them are in academic centers, the top in the country and the world. So now, again, possibly the most sensitive and specific beta amyloid marker tracer that could be available once we file.

Speaker Change: This field's about to explode and you know we're at the very beginning of it with we believe two agents that are considered next generation or best in class.

Speaker Change: and we want to be there right, right at the front of it, you know, for example, MK 6240 is...

Brian A. Markison: So NAV again, possibly the most sensitive and specific beta amyloid marker tracer that could be available once we file. So we're highly encouraged. We're placing a bet, and we're going to be at the intersection when this market explodes. Thank you. One moment for our next question. Our next question comes from the line of Matt Taylor from Jeffreys. Hi, good morning.

Speaker Change: Currently in over 90 trials. I believe 83 of them are in academic centers, the top in the country, in the world. So, NAV, again, possibly the most sensitive and specific beta amyloid marker tracer that could be available once we file.

Brian Markison: So we're highly encouraged. We're placing a bet. And we're going to be at the intersection when this market explodes.

Speaker Change: So we're highly encouraged, we're placing a bet, and we're going to be at the intersection when this market explodes.

Operator: Thank you. One moment for our next question.

Matt Taylor: Our next question comes from the line of Matt Taylor from Jeffries. All right. Good morning. Thanks for taking the question. I just wanted to ask about the two things that were up there on the beginning of a prepared remarks.

Speaker Change: Thank you. One moment for our next question.

Speaker Change: Our next question comes from the line of Matt Taylor from Jeffries.

Matthew Charles Taylor: Thanks for taking the question. I just wanted to ask about... The two main things that were updated at the beginning of the prepared remarks. One is, can you talk about your ability to grow and polarize? Next year, if we do see pricing that is lower than that of peers based on the CMS update in that segment of the market. And Bob, I was hoping you could parse out a little bit more the R&D step-up between the MK6240 NDA and the transactions to help with our modeling for the R&D step-up this year and going forward.

Matthew Charles Taylor: Good morning. Thanks for taking the question.

Matt Taylor: One is, can you talk about your ability to grow pull R5 next year? If we do see pricing that is lower than peers based on the CMS update in that segment of the market.

Paul Blanchfield: And Bob, I was hoping you could parse out a little bit more the R&D step up between MK6248 and EA and the transactions to help with our modeling for the R&D step up this year and going forward. Paul, you want to go ahead for the first part? Morning, Matt. So obviously we were incredibly pleased as we shared with the proposed CMS rule. As we affirm today, we continue to expect pull R5 to grow substantially this year in that mid 20% range. The vast majority of it driven by volume, with some slight contribution from price as our earlier pricing increases at the beginning of the year have a moderating impact based on strategic partnerships.

Speaker Change: Bob, I was hoping you could parse out a little bit more the R&D step-up between the MK-6240 NDA and the transactions to help with our modeling for the R&D step-up this year and going forward. Thank you.

Paul M. Blanchfield: So, obviously, we were incredibly pleased as we shared the proposed CMS rules. As we affirm today, we continue to expect Polarified to grow substantially this year in that mid-20 percent range, the vast majority of it driven by volume with some slight contribution from price; our earlier pricing increases at the beginning of this year have a moderating impact based on strategic partnerships. I think we are incredibly excited and positive about the future prospects of Polarified. The PSMA pet market right now is annualizing just north of $1.5 billion.

Speaker Change: As we affirm today, we continue to expect Polarified to grow substantially this year in that mid-20% range, the vast majority of it driven by volume, with some slight contribution from price as our earlier pricing increases at the beginning of this year.

Paul Blanchfield: I think we are incredibly excited and positive about the future prospects of pull R5. The PSMAPET market right now is annualizing just north of $1.5 billion if you look at all relevant players on the second quarter and you annualize that. That compared to a total addressable market that this year is north of $2 billion, and we expected grow to north of $3 billion by the end of the decade. And then if you add in that 70% of prostate cancer scans are still with less specific conventional imaging and only 30% is with what we would call this next generation of PSMAPET scans led by pull R5.

Speaker Change: have a moderating impact based on strategic partnerships.

Speaker Change: The PSMA pet market right now is annualizing just north of $1.5 billion if you look at all relevant players in the second quarter and you annualize that. That's compared to a total addressable market that this year is north of $2 billion.

Paul M. Blanchfield: If you look at all relevant players in the second quarter and you annualize that, that's compared to a total addressable market that is north of $2 billion this year, and we expect it to grow to north of $3 billion by the end of the decade. And then if you add in that 70 percent of prostate cancer scans are still with less specific conventional imaging, and only 30 percent are with what we would call this next generation of PSMA pet scans led by Polarized.

Speaker Change: and we expect to grow to north of $3 billion by the end of the decade.

Speaker Change: are still with less specific conventional imaging and only 30% is with what we would call this next generation of PSMA PET scans led by Polarify. We think there's significant opportunity for this market to expand and to continue to grow.

Paul M. Blanchfield: We think there's significant opportunity for this market to expand and to continue to grow. Naturally, we've been putting in place a number of initiatives to ensure Polarified's leadership and the market's continued expansion, led by our commercial and clinical brand differentiation in the market through our commercial teams as well as our marketing efforts. And so we haven't put a number on 2025 at this point yet, but we remain very positive that Polarified and the overall market will continue to grow. And that Polarified will retain its leadership.

Paul Blanchfield: We think there's significant opportunity for this market to expand and to continue to grow. Naturally, we've been putting in place a number of initiatives to ensure pull R5's leadership and the market to continue expand, led by our commercial and clinical brand differentiation in the market through our commercial teams as well as our marketing efforts.

Speaker Change: Naturally, we've been putting in place a number of initiatives to ensure Polarified leadership and the market to continue to expand, led by our

Bob Marshall: And so we haven't put a number on 2025 at this point yet, but we remain very positive that pull R5 and the overall market will continue to grow and the pull R5 will remain retained its and Matt, just a dear question about helping with modeling on the different R&D assets, if you will, the clinical pipeline, then look at the totals, you know, I would put, you know, 70% of it really kind of falls on on Nav 4694 in RM2 with more or less the balance going to MK620, that obviously will, the MK620 will evolve probably quicker in the sense of an NDA filing projected for 2025, where, of course, as we get closer with a commercialization effort, things will change, but I'll provide color on that when we get to 2025.

Speaker Change: And so, we haven't put a number on 2025 at this point yet, but we remain very positive that Polarify and the overall market will continue to grow, and that Polarify will retain its leadership position.

Paul M. Blanchfield: And Matt, just to your question about helping with modeling on the different R&D assets, if you will, the clinical pipeline, when I looked at the totals, I would put, you know, 70% of it really kind of falls on NAV4694 and RM2, with more or less the balance going to MK6240. That obviously will, the MK6240 will probably evolve quicker in the sense that of an NDA filing projected for 2025, where, of course, as we get closer to a commercialization effort, things will change. But I'll provide more color on that when we get to 2025.

Matthew Charles Taylor: And Matt, just to your question about helping with modeling on the different R&D assets, if you will, of the clinical pipeline. As I look at the totals, you know, I would put

Operator: Thank you. One moment for our next question.

Robert J. Marshall: Thank you. One moment for our next question. Our next question comes from the line of Tara Bancroft from TD Cowell. Hi, good morning.

Tara Bancroft: Our next question comes from the line of Tara Bancroft from TD Cowan. Hi, good morning.

Speaker Change: Thank you. One moment for our next question.

Speaker Change: Our next question comes from the line of Tara Bancroft from TD Cowen.

Tara Bancroft: So I was hoping you could explain a little bit more of your thinking on the potential impact of other entrants to polarize the market in the coming years. What assumptions do you have there for market share and what goes into your confidence in maintaining your share? Thank you, Thanks, Tara.

Tara Bancroft: So I was hoping you could explain a little bit more of your thinking on the potential impact of other entrants to Polarify in the out years. What assumptions you have there for market share and what goes into your confidence in maintaining your share. Thanks. Thanks, Tara. We certainly are aware of the clinical development environment for other players. I think overall, we believe that Polarify has significant and sustainable competitive advantages, both commercially and clinically, that we've outlined before. We take new competition incredibly seriously. Overall, I think we believe that, first and foremost, raises awareness in the marketplace where there is broader voice to demonstrate the potential for PSMA PET imaging.

Paul M. Blanchfield: We certainly are aware of the clinical development environment for other players. But, overall, we believe that Polarify has significant and sustainable competitive advantages, both commercially and clinically, as we've outlined before. We take new competition incredibly seriously.

Speaker Change: Thanks Tara. We certainly are aware of the clinical development environment for other players.

Speaker Change: I think overall, we believe that Polarify has significant and sustainable competitive advantages, both commercially and clinically, that we've outlined before. We take new competition incredibly seriously. Overall, I think we believe that, first and foremost, raises awareness in the marketplace.

Amanda Morgan: Overall, I think we believe that first and foremost raises awareness in the marketplace, where there is a broader voice to demonstrate the potential for PSMA PET imaging. And so I think we're very positive about Polarify's current position. We think we continue to have a leading product that has demonstrated superiority out there in the marketplace with what we're able to help physicians make more informed decisions to manage prostate cancer patients.

Speaker Change: where

Paul Blanchfield: And so I think we're very positive about Polarify's current position. We think we continue to have a leading product that has demonstrated superiority out there in the marketplace with what we're able to be able to help physicians make more informed decisions to manage prostate cancer patients.

Speaker Change: There is broader voice to demonstrate the potential for PSMA PET imaging. And so I think we're very positive about Polarify's current position. We think we

Speaker Change: continue to have a leading product that has demonstrated superiority out there on the marketplace with what we're able to be able to help physicians make more informed decisions to manage prostate cancer patients. And so we take new entrants quite seriously, but we continue to invest to invest in lifecycle management, in product improvements, as well as in our commercial expertise to continue to grow and lead in this space for many years to come.

Paul Blanchfield: And so we take new entrance quite seriously, but we continue to invest in life cycle management, in product improvements, as well as in our commercial expertise to continue to grow and lead in this space for many years to come. Amanda, anything you want to add? Thank you. Okay. Thank you. One moment for our next question.

Amanda Morgan: And so we take new entrants quite seriously, but we continue to invest in lifecycle management, in product improvements, as well as in our commercial expertise to continue to grow and lead in this space. Amanda, anything you want to add? No, I think it's over.

Speaker Change: Amanda, anything you want to add?

Operator: Thank you. One moment for our next question. Our next question comes from Larry Solow from CJS Security. Great. Thank you. Good morning.

Amanda: No, I think we're covered.

Larry Solo: Our next question comes in the line of Larry Solo from C.J.S. Securities. Great. Thank you. Good morning. I guess two quick follow-ups, if I may just squeeze two in. I guess set another way or ask another way.

Amanda: Thank you. One moment for our next question.

Speaker Change: Our next question comes from the line of Larry Solow from CJS Securities.

Lawrence Scott Solow: I guess two quick follow-ups, if I may just squeeze two in. I guess said another way or asked another way, do the CMS proposals at all change your ongoing negotiations and sort of your strategic initiatives in terms of locking in customers? You have to play a little bit of a waiting game now.

Lawrence Scott Solow: Great, thank you. Good morning. I guess two quick follow-ups if I may just squeeze two in. I guess said another way or asked another way, does the CMS proposals...

Larry Solo: Does the CMS proposals at all change your ongoing negotiations and sort of your strategic initiatives in terms of locking in customers? Do you have to play a little bit of a waiting game now? Is that change at all?

Lawrence Scott Solow: at all change your ongoing negotiations and sort of your strategic initiatives in terms of locking in customers? Do you have to play a little bit of a waiting game now? Does that change at all? And then second question, just you mentioned the total market size today.

Brian A. Markison: Does that change at all? And then, second question: you mentioned the total market size today in the U.S. is about $1.5 billion. That basically just sounds like you're adding up.

Larry Solo: And then second question, you mentioned the total market size today in the US is about 1.5 billion. That basically just sounds like you're adding up the logistics and your Polarify.

Speaker Change: in the U.S. is about $1.5 billion and that basically just sounds like you're adding up

Paul Blanchfield: Are there any other competitors doing anything meaningful or making any inroads on that market? Yeah, thanks for the questions. As far as our commercial game plan, nothing changes. We're committed to our strategic partnerships; we're committed to bringing the best product to more people, so nothing changes. As far as competition is concerned, look, we monitor it; we're aware of it.

Brian A. Markison: [inaudible] Yeah, no, thanks for the questions. As far as our commercial game plan, nothing changes.

Brian A. Markison: We're committed to our strategic partnerships. We're committed to bringing the best product to more people, so nothing changes. As far as competition is concerned, Look, we monitor it, we're aware of it. Anything a competitor does is meaningful, and we'll assess how we respond to it. But I'll let Amanda elaborate a little bit on that point.

Speaker Change: Yeah, no, thanks for the questions. As far as our commercial game plan, nothing changes. We're committed to our strategic partnerships. We're committed to bringing the best product to more people, so nothing changes. As far as competition is concerned,

Speaker Change: Look, we monitor it, we're aware of it.

Paul Blanchfield: Anything demands to elaborate a little bit on that point. Yeah, thanks, Brian. So, from a competitive dynamic perspective, Polarify is the clear market leader in PSMA PET imaging with more than 400,000 scans since we've launched. We believe our continued market leadership reflects our clear clinical and commercial value proposition. We've seen our market leadership continue to expand and solidify with our absolute annual revenue growth, outpacing that of what we see with our competitors. In addition, our market share remains relatively stable as we share during the call in the mid-60 percent range, even amidst three other commercial competitors.

Speaker Change: Anything a competitor does is meaningful.

Amanda Morgan: Thanks, Brian. So from a competitive dynamic perspective, Polarify is the clear market leader in PSMA PET imaging, with more than 400,000 scans since we launched. We believe our continued market leadership will reflect our clear clinical and commercial value. We've seen our market leadership continue to expand and solidify with our absolute annual revenue growth outpacing that of what we see with our competitors. In addition, our market share remains relatively stable, as we shared during the call in the mid-60% range, even amidst three other commercial competitors.

Speaker Change: and we'll assess how we respond to it, but I'll let Amanda elaborate.

Amanda: A little bit on that point. Thanks, Brian . So, from a competitive dynamic perspective, Polarify is the clear market leader in PSMA PET imaging, with more than 400,000 scans since we've launched.

Amanda: We've seen our market leadership continue to expand and solidify with our absolute annual revenue growth outpacing that of what we see with our competitors.

Amanda: In addition, our market share remains relatively stable as we shared during the call in the mid-60% range, even amidst three other commercial competitors. And overall, finally, we believe there remains a substantial growth opportunity in the PSMA pet market.

Operator: And overall, finally, we believe there remains a substantial growth opportunity in the PSMA PET market. As Paul shared with you earlier, this is evidenced by the $2 billion TAM current addressable market and the $3 billion future addressable market, and with a significant number of prostate cancer scans that are performed with conventional imaging instead of PSMA PET. So we continue to focus on ensuring Polarify continues to grow and remains the market leader. And in the near term, we've affirmed our revenue guidance and expect Polarify's growth to be in the mid 20% range, predominantly driven by volume.

Paul Blanchfield: And overall, finally, we believe there remains a substantial growth opportunity in the PSMA PET market. As Paul shared with you earlier, it's evident by the $2 million dollar current addressable market and the $3 billion dollar future addressable market. And with the significant number of project cancer scans that are performed with conventional energy instead of PSMA PET. So, we continue to focus on ensuring Polarify continues to grow and remains the market leader. And in the near term, we've affirmed our revenue guidance and specced Polarify to grow in the mid-20 percent range, predominantly driven by volume. Thank you.

Amanda: and with a significant number of prostate cancer scans that are performed with conventional imaging instead of PSMA PET.

Amanda: So we continue to focus on ensuring Polarify continues to grow.

Amanda: and remains the market leader.

Operator: One moment for our next question.

Speaker Change: Thank you. One moment for our next question.

Yuan Chen: Our next question comes from the line of Yuan Chen from B. Riley. Good morning. Congrats on the commercial progress of Generalify. We are a little bit surprised to see the MK6240 and the sub-nation and scheduling condition of five. So can you maybe clarify what was discussed with FDA and what would be the target indication for this agent? And thanks, and you may be quickly commenting on your current stock on the share buy-back and development. Thank you.

Yuan Zhi: One moment for our next question. Our next question comes from the line of Yuan Chin from B Riley. Good morning.

Amanda: Our next question comes from the line of Yuan Chin from B. Reilly.

Brian A. Markison: Congratulations on the commercial progress of Generify. We are a little bit surprised to see the MK6240 NDA submission scheduled for 2025. So can you maybe clarify what was discussed with FDA and what would be the target indication for this agent?

Yuan Zhi: So can you maybe clarify what was discussed with FDA and what would be the target indication for this agent? And then can you maybe quickly comment on your current thoughts on the share buyback and demand? Thank you.

Brian A. Markison: And then can you maybe quickly comment on your current thoughts on the share buyback and demand. Thank you. Yeah, so we'll start with the first comment on the share buyback. Bob, do you want to flag that? Unknown Attendee.

Bob Marshall: Yes, so we'll start with the share buy-back first carbon. Bob, do you want to flag that? All right. So I'll start with that. So from a by-back perspective, obviously, when we think about capital allocation, we broadly consider any, you know, all elements. Obviously, our first priority is going to be business development. You see that's executed that here in Q2. We still have plenty of dry powder, but we also have a, you know, a full pipeline. It's a topic that we have continuously taken up with the board, and we will continue to evaluate those opportunities as it becomes appropriate.

Robert J. Marshall: All right, so I'll start with that. So from a buyback perspective, obviously, when we think about capital allocation, we broadly consider any, you know, all elements. Obviously, our first priority is going to be business development. You can see that we have plenty of dry powder here in Q2, but we also have a, you know, a full pipeline. It's a topic that we have continuously taken up with the board, and we will continue to evaluate those opportunities as it becomes appropriate.

Speaker Change: We broadly consider all elements. Obviously, our first priority is going to be business development. You see that's execute that here in Q2.

Jeff Humphrey: Yes, and thanks for the question about MK6240. We've recently held a pre-NDA meeting with the FDA. And we expect to submit the NDA for MK6240 in 2025. We look forward to sharing more about the NDAs in the future. Thanks for the question. Thank you. One moment for our next question.

Robert J. Marshall: Yes, and thanks for the question about MK-6240. We recently held a pre-NDA meeting with FDA, and we expect to submit the NDA for MK-6240 in 2025. We look forward to sharing more about the regulatory pathways and timelines for MK-NF in the future.

Speaker Change: Yes, and thanks for the question about NK6240. We've recently held a pre-NDA meeting with FDA.

Speaker Change: And we expect to submit the NDA for MK-6240 in 2025. We look forward to sharing more about the regulatory pathways and timelines for MK-NF in the future. Thanks for the question.

Brian A. Markison: Thanks for the question. Thank you. One moment for our next question. Our next question comes from David Turkaly from Citizens JMP. Hey, great. Maybe just one for Bob.

David Turkaly: Our next question comes to the line of David Turkaly from Citizens JMP. Hey, great.

Speaker Change: Thank you. One moment for our next question.

Yuan Zhi: Our next question comes in the line of David Turkaly from Citizens JMP.

David Louis Turkaly: And I appreciate the commentary you made on seasonality because we kind of look at the back half. I know you don't want to explicitly call out three versus four Q by product, but, Could, I mean, it looks like it may be polarized, could be sort of flattish or maybe even down in 3Q versus 2Q, just to kind of get that cadence right for the year.

Bob Marshall: Maybe just one for Bob. And I appreciate the commentary made on seasonality, but we kind of look at the back half. I know you want to explicitly call out three verse for you by product, but could that, I mean, it looks like it may be polarified, could be sort of flatish or maybe even down in three Q versus two Q just to kind of get that cadence right for the year. Is that kind of a fair assumption? You know, from as we look at it, I mean, we've given enough pieces and parts to do the math, I think.

David Louis Turkaly: Hey great maybe just one for Bob and I appreciate the commentary you made on seasonality because we kind of look at the back half I know you don't want to explicitly call out 3 verse 4 cue

Speaker Change: by product, but could I mean it looks like it may be polarified could be sort of flattish or maybe even down in 3q Versus 2q just to kind of get that cadence right for the year. Is that kind of a fair assumption?

Robert J. Marshall: You know, as we look at it, I mean, we've given you enough pieces and parts to do the math, I think. And sequentially, you're going to see it, particularly from a gross, polarized volume perspective; it will continue to increase from a volume perspective. We do think, though, that, you know, those seasonal trends from, you know, as these strategic partnerships with key customers come into play, will be mitigated more fully as we get into the back half of the year. But to be fair, I mean, our overall guidance hasn't changed from our perspective from a mid 20% growth rate. So the view really hasn't, you know, mitigated itself throughout the balance of the year.

Bob Marshall: And sequentially, you're going to see it, particularly from a gross polarified volume perspective. It will continue to increase from a volume perspective. We do think, though, that those seasonal trends from, as these strategic partnerships with key customers come into play, will mitigate more fully as we get into the back half of the year. But to be fair, I mean, our overall guidance hasn't changed from our perspective, from a mid-20% growth rate. So the view really hasn't, you know, mitigated itself throughout the balance of the year. So yes, I do expect that Q3 will be the lower of the two quarters for planning purposes.

Speaker Change: You know, from as we look at it, I mean, we've given enough pieces and parts to do the math, I think, and sequentially, you're going to see it, particularly from a gross, polarified volume perspective.

Speaker Change: It will continue to increase from a volume perspective. We do think though that...

Speaker Change: those seasonal trends as these strategic partnerships with key customers come into play, we'll mitigate more fully as we get into the back half of the year. But to be fair, I mean, our overall guidance hasn't changed from our perspective from a mid 20% growth rate.

Speaker Change: So the view really hasn't, you know, mitigated itself throughout the balance of the year. So yes, I do expect that Q3 will be the lower of the two quarters for planning purposes.

Operator: Thank you.

Robert J. Marshall: So, yes, I do expect that Q3 will be the lower of the two quarters for planning purposes. Thank you. One moment for our next question. Our next question comes from the line of Justin Walsh from Jones Trading. Hi, thanks for taking the question. Can you provide any color on your expectations for the upcoming splash readout and what you would like to see there to convince you to move forward with your point Lily partner?

Justin Walsh: One moment for our next question.

Speaker Change: Thank you. One moment for our next question.

Justin Walsh: Our next question goes to the line of Justin Walsh from Jones Trading. Hi, thanks for taking the question.

Speaker Change: Our next question comes from the line of Justin Walsh from Jones Trading.

Brian Markison: Can you provide any color on your expectations for the upcoming splash readout and what you would like to see there to convince you to move forward with your Point Lily partnership? Yeah, thanks for the question. You know, look, we're going to see additional data coming this quarter. We've said that before. And you know, as the trial progresses, you know, we don't exactly control the timeline, but we have a great feel that it'll be the squirt this third quarter. Our expectation is to move ahead.

Justin Howard Walsh: Hi, thanks for taking the question. Can you provide any color on your expectations for the upcoming splash readout and what you would like to see there to convince you to move forward with your Point Lily partnership? Transcribed by https://otter.ai

Justin Howard Walsh: Yeah, thanks for the question. You know, look, we're going to see additional data coming this quarter. We've said that before.

Speaker Change: Yeah, thanks for the question. You know, look, we're going to see additional data coming this quarter. We've said that before.

Brian A. Markison: And, you know, as the trial progresses, we don't exactly control the timeline, but we have a great feel that it'll be this third quarter. Our expectation is to move ahead, and that's the best I can tell you at this time. We're pretty comfortable with what we're seeing and what we have seen in meeting our primary endpoints. And obviously, the overall survival crossover analysis and the confounding of it is something that's been an industry topic now for over a year.

Speaker Change: As the trial progresses, we don't exactly control the timeline, but we have a great feel that it will be this third quarter.

Brian Markison: And that's the best I could tell you at this time. We're pretty comfortable with what we're seeing and what we have seen in meeting our primary endpoint. And obviously, the overall survival crossover analysis and the confounding of it is something that's been an industry topic now for over a year. We like the asset. We'd like to move ahead. We're encouraged by what we've seen already with our primary endpoint.

Speaker Change: Our expectation is to move ahead, and that's the best I can tell you at this time. We're pretty comfortable with what we're seeing and what we have seen in meeting our primary endpoint.

Speaker Change: and obviously the overall survival crossover analysis and the confounding of it is something that's been an industry topic now for over a year.

Brian A. Markison: We like the asset, we'd like to move ahead, we're encouraged by what we've seen already with our primary endpoint, and we'll update the world when we know what we have. Thank you. One moment for our next question. Our next question comes from the line of Andy Shea from William Blair. All right.

Speaker Change: We like the asset, we'd like to move ahead, we're encouraged by what we've seen already with our primary endpoint, and we'll update the world when we know what we have.

Operator: And we'll update the world when we know what we have. Thank you. One moment for our next question.

Andy Shay: Our next question comes to the line of Andy Shay from William Blair. Thanks for taking our question.

Speaker Change: Thank you. One moment for our next question.

Speaker Change: Our next question comes from the line of Andy Shea from William Blair.

Andy Shea: Thanks for taking our question. Um, I'm just wondering if you could educate us on the potential product profile differentiation of NAV4694. I guess in the market, Amy Vid has been approved for over a decade now. It's from Eli Lilly. Just wondering how you plan to provide that positioning differentiation as you kind of launch into a field that already has an existing standard of care. Thank you.

Jeff Humphrey: I'm just wondering if you could educate us on the potential product profile differentiation of NAV 4694. I guess in the market, Amy Vids. I had an improve for over a decade now, that's from Eli Lilly, just wondering how you plan to provide that positioning differentiation as you kind of launch into a field that already has existing standard of care. Thank you.

Andy Shea: Alright, thanks for taking our question.

Andy Shea: I'm just wondering if you could educate us on the potential product profile differentiation of NAV4694.

Andy Shea: I guess in the market.

Speaker Change: Unknown Attendee Amy did have an improved for over a decade now. That's from Eli Lilly.

Speaker Change: Just wondering how...

Speaker Change: You plan to provide that positioning differentiation as you kind of launch into a field that already has existing standard of care. Thank you.

Jeff Humphrey: Jeff, do you want to kick that off for that? Yeah, thank you. Thank you. So for now, it's currently in phase three development as expected. We expect to bring it through pivotal trials and into commercialization. The agent has higher sensitivity and specificity, unless off-target binding in the brain, that potentially allows for clearer images, better understanding of the anatomic distribution, and importantly, earlier detection of data amyloids that earlier detection may lead to earlier treatment and potentially better outcomes. Thanks for the question. Thank you.

Jeff Humphrey: Yeah, thank you. Thank you. So for NAV, it's currently in phase three development, as expected. We expect to bring it through pivotal trials and into commercialization. The agent has higher sensitivity and specificity and less off-target binding in the brain, which potentially allows for clearer images, better understanding of the anatomic distribution, and importantly, earlier detection of beta amyloid.

Speaker Change: Jeff, do you want to kick that off? Yeah, thank you, thank you. So for NAV, it's currently in phase 3 development as expected. We expect to bring it through pivotal trials and into commercialization.

Speaker Change: The agent has higher sensitivity and specificity and less off-target binding in the brain that potentially allows for clearer images, better understanding of the anatomic distribution

Jeff Humphrey: That earlier detection may lead to earlier treatment and potentially better outcomes. Thanks for the question.

Speaker Change: importantly, earlier detection of beta amyloid. That earlier detection may lead to earlier treatment and potentially better outcomes.

Operator: One moment for our next question. Our next question comes from the line of Kemp Dolliver from Brookline Capital Markets. All right, thank you. What is your ability to leverage your existing commercial footprint for both 6240 and then potentially PNT-2002? I think that's a great question. I appreciate it. You want to take it, Paul, or not?

Operator: One moment for our next question.

Speaker Change: Thanks for the question.

Kemp Dolliver: Our next question comes to the line of Kemp, Dolliver, from Brookline Capital Markets. Hi, thank you. What is your ability to leverage your existing commercial footprint for both 6240 and potentially PNT-002? I think that's a great question. I appreciate it. You want to take it forward? I think it's appreciated the question. I think we're excited to build from a position of strengths, from our long history and existing capabilities in radio pharmaceuticals, both diagnostics and what we build building in therapeutics. And I'd cover a few specific points. Within the all-timer space, both NAV and MK are F-18-based products.

Speaker Change: Thank you. One moment for our next question.

Speaker Change: Our next question comes to the line of Kemp Dolliver from Brookline Capital Markets.

Brian Kemp Dolliver: All right, thank you.

Brian Kemp Dolliver: What is your ability to leverage your existing commercial footprint for both 6240 and then potentially PNT-2002?

Brian Kemp Dolliver: I think it's, appreciate the question. I think we're excited to build from a position of strength from our long history and existing capabilities in radiopharmaceuticals, both diagnostics and what we build, building in therapeutics. And I'd cover a few specific points within the Alzheimer's space, both NAV and MK are F-18 based products. So they will be manufactured and we would be able to lever the existing PMS network with the out the door times and the production slots that we've been working with our key partners that now are across fifty eight different pet manufacturing facilities in the country.

Speaker Change: I think that's a great question. I appreciate it. You want to take it, Paul? I appreciate the question. I think we're excited to build from a position of strength, from our long history and existing capabilities in radiopharmaceuticals, both diagnostics and what we're building in therapeutics.

Paul: and I'd cover a few specific points. Within the Alzheimer's space, both NAV and MK are F-18 based products.

Brian Markison: So they will be manufactured, and we would be able to lever the existing PMS network out the door times and the production slots that we've been working with our key partners that now are across 58 different pet manufacturing facilities in the country. And so we believe that comes from a position of strength to be able to build on that and enhance those relationships from a production and delivery perspective, of which we all know that in radio pharmaceuticals and diagnostics in particular, that can be a hurdle for new entrance and others in the market. From a commercial perspective, if we look at where the imaging agents would be administered and scanned for all-timers, we are already in the vast majority of PET CT sites across the country.

Speaker Change: So they will be manufactured and we would be able to lever the existing PMS network.

Paul: We have the out-the-door times and the production slots that we've been working with our key partners that now are across 58 different pet manufacturing facilities in the country. And so we believe that comes from a position of strength to be able to build on that and enhance those relationships.

Brian Kemp Dolliver: And so we believe that comes from a position of strength to be able to build on that and enhance those relationships from a production and delivery perspective of which we all know that in radiopharmaceuticals and diagnostics in particular, that can be a hurdle for new entrants and others in the market. From a commercial perspective, if we look at where the imaging agents would be administered and scanned for Alzheimer's, we are already in the vast majority of PET-CT sites across the country. Those same sites would be adding capacity to be able to scan for Alzheimer's agents, both tau tangles and those targeting beta amyloid.

Paul: from a production and delivery perspective, of which we all know that in radiopharmaceuticals and diagnostics in particular, that can be a hurdle for new entrants and others in the market.

Paul: From a commercial perspective, if we look at where the imaging agents would be administered and scanned for Alzheimer's,

Paul: We are already in the vast majority of PET-CT sites across the country.

Brian Markison: Those same sites would be adding capacity to be able to scan for all-timers agents, both pow tangles and those targeting beta amyloids. And so we would be able to lever our existing infrastructure and capabilities there. Naturally going into all-timers would require increased support around referring physicians, recognizing that with Polarify, we're currently calling on neurologists and oncologists, but neurologists and those memory clinics and others that we'll be seeing and treating all-timers patients would require investment. As Bob has mentioned, we make investments commensurate with the commercial opportunity, but we do have significant infrastructure there that we could lever.

Paul: Those same sites would be adding capacity to be able to scan for Alzheimer's agents, both tau tangles and those targeting beta amyloids, and so we would be able to lever our existing infrastructure and capabilities there.

Paul M. Blanchfield: And so we would be able to lever our existing infrastructure and capabilities there. Naturally, going into Alzheimer's would require increased support around referring physicians, recognizing that with Polarify, we're currently calling on urologists and oncologists. But neurologists and those memory clinics and others that will be seeing and treating Alzheimer's patients would require investment. From a therapeutic perspective, specifically with PNT2002, similarly, if we look at the treating sites for PET-CT, there's about 2,000 in the country, and there's about 300 plus radiopharmaceutical therapeutic sites, with almost all of those therapeutic sites having imaging.

Paul: Naturally going into Alzheimer's would require increased

Paul: support around referring physicians, recognizing that with Polarify we're currently calling on urologists and oncologists.

Speaker Change: But neurologists and those memory clinics and others that will be seeing and treating Alzheimer's patients would require investment. As Bob has mentioned, we make investments commensurate with the commercial opportunity. But we do have significant infrastructure there that we could leverage.

Brian Markison: From a therapeutic perspective, specifically with PNT2002, similarly, if we look at the treating sites for PET CT, there's about 2,000 in the country, and there's about 300-plus radiopharmaceutical therapeutic sites, with almost all of those therapeutic sites having imaging. And so we already have relationships at the site that would be treating for PNT2002 as well as PNT2003, and we would be able to lever that infrastructure. Again, we would make commensurate investments on the referring physician landscape. For O3, it would be with the neuroendocrine treating physicians, which could be medical oncologists as well as radiation oncologists and the like.

Bob: From a therapeutic perspective, specifically with PNT2002.

Speaker Change: Similarly, if we look at the treating sites for PET-CT, there's about 2,000 in the country, and there's about 300-plus radiopharmaceutical therapeutic sites.

Paul M. Blanchfield: And so we already have relationships at the sites that would be treating for PNT-02, as well as PNT-03, and we'd be able to leverage that infrastructure. Again, we would make commensurate investments in the referring physician landscape. For PNT-03, it would be with the neuroendocrine treating physicians, which could be medical oncologists, as well as radiation oncologists and the like.

Speaker Change: with almost all of those therapeutic sites having imaging.

Bob: And so we already have relationships.

Speaker Change: at the sites that would be treating for PNTO2 as well as PNTO3 and would be able to lever that infrastructure. Again, we would make commensurate investments on the referring physician landscape for 03. It would be with the

Speaker Change: Neuroendocrine treating physicians which could be medical oncologists as well as radiation oncologists and the like. We already have some presence there with Polarify but naturally we would make appropriate investments.

Paul M. Blanchfield: We already have some presence there with Polarify, but naturally, we would make appropriate investments. Unknown Attendee, Brian Dolliver, Yuan Zhi, Lantheus Holdings Inc. 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 11 again. We ask that you please limit yourselves to one question.

Brian Markison: We already have some presence there with Polarify, but naturally we would make appropriate investments commensurate with the opportunity. And so we feel we're coming from a position of strength where we lever our existing manufacturing as well as commercial relationships and look forward to bringing these exciting agents, if approved, to the market. Thank you.

Bob: [inaudible]

Richard Newitter: 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. We ask that you please limit yourself to one question. Just two quick follow-ups, it sounds like the vast majority of the bridge from your old earnings guidance to the new is, you know, some higher share account that we have to move out 15 cents, and then it sounds like the R&D step up is most of the rest there, 40 plus cents of the rest. Is that right, or is there anything else in an affect assumptions or even gross margin?

Speaker Change: Thank you. As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. We ask that you please limit yourselves to one question.

Richard Samuel Newitter: Just two quick follow-ups. It sounds like the vast majority of the bridge from your old earnings guidance to the new is, you know, some higher share count, but we estimate about $0.15. And then it sounds like the R&D step up is most of the rest, or $0.40 plus the rest. Is that right?

Speaker Change: Our next question comes from the line of Richard Newitter from Truist Securities.

Richard Samuel Newitter: Unknown Attendee Hi, thanks. Just two quick follow-ups. It sounds like the vast majority of the bridge from your old earnings guidance to the new is

Richard Samuel Newitter: some higher share count, we estimate about $0.15.

Robert J. Marshall: Or is there anything else in op-ed consumptions or even gross margin? I think your last gross margin guide was around flat year over year at $0.23. Does that still stand?

Speaker Change: Most of the rest, there are 40 plus cents of the rest.

Richard Newitter: I think your last gross margin guide was a round flat year over year with 23, so that still stands, and then just on Polarify, you know, can you grow Polarify next year? I think the street has had a mid single digit growth rate for Polarify. I'm just wondering if, you know, that's the reasonable level. I think in your prepared remarks, you said you were confident in Polarify continuing to grow into the future. So reconcile that, please. Thank you. Rich, your reconciliation was basically spot on. You know, when we when they started the guide paragraph, they did say that, you know, naturally, when we started from our starting jumping off point of $7.7.20, we hadn't taken the consideration, you know, this acceleration in R&D spend, the transactions that we do because you don't forecast that kind of stuff.

Speaker Change: Is that right, or is there anything else in op-ed assumptions, or even gross margin, I think your last gross margin guide was a round flat year over year with 23. Does that still stand? And then, just on Polarify, you know...

Robert J. Marshall: And then just on Polarify, you know, Can you grow Polarify next year? I think the street has a mid-single-digit growth rate for Polarify, and I'm just wondering if that's a reasonable level.

Speaker Change: Can you grow Polarify next year? I think the street has a mid-single digit growth rate for Polarify. I'm just wondering if that's a reasonable level. I think in your prepared remarks you said you were confident in Polarify continuing to grow into the future. So reconcile that please. Thank you.

Paul M. Blanchfield: I think in your prepared remarks, you said you were confident in Polarify continuing to grow into the future. So reconcile that, please. Rich, your reconciliation is basically spot on. You know, when we started the guidance paragraph, I did say that, you know, naturally, when we started from our starting jumping off point of $7, $7.20, we hadn't taken into consideration, you know, this acceleration in R&D spend, the transactions that we do, because you don't forecast that kind of stuff.

Speaker Change: Rich, your reconciliation is basically spot-on.

Speaker Change: When I started the guidance paragraph, I did say that, you know,

Speaker Change: Naturally, when we started from our starting jumping off point of $7, $7.20, we hadn't taken into consideration, you know, this acceleration in R&D spend, the transactions that we do, because you don't forecast that kind of stuff.

Bob Marshall: Sometimes these opportunities arise, and you take advantage of it. So, from a reconciliation perspective, you've got exactly the share count, which is just a mathematical issue. And then you write the rest of it; the majority of the additional spend is R&D based. But that considers, you know, both what we spent in Q2 versus, and as well as Q3 and 4. So again, yeah, I mean, our underlying operational profile hasn't really changed, other than the ability now to invest in an R&D pipeline that will, you know, launch us into our future in terms of, you know, additional growth drivers.

Robert J. Marshall: So, from a reconciliation perspective, you've got exactly the share count, which is just a mathematical issue. And then you're right, the rest of it, the majority of the additional spend is R&D based. But that considers, you know, both what we spent in Q2 and as well as Q3 and Q4. So again, yeah, I mean, our underlying operational profile hasn't really changed other than the ability now to invest in an R&D pipeline that will, you know, launch us into our future in terms of, you know, additional growth drivers. Ladies and gentlemen... Go ahead, Paul.

Speaker Change: Sometimes these opportunities arise and you take advantage of it. So from a reconciliation perspective, you've got exactly the share count, which is just a mathematical issue.

Speaker Change: And then, you're right, the rest of it, the majority of the additional spend is R&D based.

Speaker Change: But that considers, you know, both what we spent in Q2 versus and as well as Q3 and Q4. So again, yeah, I mean, our underlying operational profile hasn't really changed other than the ability now to invest.

Speaker Change: in an R&D pipeline that will launch us into our future in terms of additional growth drivers.

Brian Markison: Rich, maybe just some added color on 2025. Right today, we're talking about 24 and what we're able to deliver to have Polarify be the first ever radiopharmaceutical diagnostic blockbuster with over a billion dollars in sale. We've guided to Polarify growing mid 20%. We grew almost 30% year over year this quarter. We're highlighting that the current market is annualizing at about 1.5 billion and has the potential this year to be north of 2 billion and continue to grow. And so we believe we are well positioned. Naturally, there will be a time in a place when we give specific 2025 guidance, but suffice it to say a product that's been growing 30% in the first half of this year, 30% year over year, with our guide to be in the mid 20%.

Paul M. Blanchfield: Rich, maybe just some added color on 2025, right? Today, we're talking about 24 and what we're able to deliver to have Polarify be the first ever radiopharmaceutical diagnostic blockbuster with over a billion dollars in sales. We've guided to Polarify growing mid 20%. We grew almost 30% year over year this quarter. We're highlighting that the current market is annualizing at about 1.5 billion and has the potential this year to be north of 2 billion and continue to grow.

Speaker Change: Ladies and gentlemen...

Speaker Change: Go ahead, Paul. Rich, maybe just some added color on 2025, right? Today we're talking about 24 and what we're able to deliver to have Polarify be the first ever radiopharmaceutical diagnostic blockbuster with over a billion dollars in sales.

Speaker Change: We've guided to Polarify growing mid-20%. We grew almost 30% year-over-year this quarter.

Speaker Change: We're highlighting that the current market is annualizing at about 1.5 billion and has the potential this year to be north of 2 billion and continue to grow. And so we believe we are well positioned. Naturally, there will be a time and a place when we give specific 2025 guidance, but

Paul M. Blanchfield: And so we believe we are well positioned. Naturally, there will be a time and a place when we give specific 2025 guidance, but suffice it to say a product that's been growing 30% in the first half of this year. 30% year over year with our guide to be in the mid 20%. We still have some ample room and momentum to continue to grow and to lead and the recent CMS proposed rules only further support that story. In addition to the commercial differentiation, the continued life cycle management and so we remain very positive on polarifies near and long term growth.

Speaker Change: Suffice it to say, a product that's been growing 30% in the first half of this year, 30% year-over-year, with our guide to be in the mid-20%, we still have some...

Operator: We still have ample room and momentum to continue to grow and to lead, and the recent CMS proposed rules only further support that story. In addition to the commercial differentiation, the continued life cycle management. And so we remain very positive on Polarify's near and long-term growth.

Speaker Change: ample room and momentum to continue to grow and to lead.

Speaker Change: and the recent CMS proposed rules only further support that story in addition to the commercial differentiation, the continued life cycle management, and so we remain very positive on Polarify's near and long-term growth potential.

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

Operator: 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. [inaudible] Unknown Attendee, Brian Dolliver, Unknown Attendee, Unknown Attendee, Unknown Attendee, Unknown Attendee, Brian Dolliver, Unknown Attendee, Unknown Attendee, Unknown Attendee, ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Unknown Attendee, Brian Dolliver, Unknown Attendee, Unknown Attendee, Unknown Attendee, Unknown Attendee, Brian Dolliver, Unknown Attendee, Unknown Attendee, Unknown Attendee, Brian Dolliver, Unknown Attendee, Unknown Attendee, Unknown Attendee, [inaudible] Unknown Attendee, Brian Dolliver, Unknown Attendee, Unknown Attendee, Unknown Attendee, Unknown Attendee, Brian Dolliver, Unknown Attendee, Unknown Attendee, Unknown Attendee, Unknown Attendee, Brian Dolliver, Unknown Attendee, Unknown Attendee,

Speaker Change: 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.

Operator: You may disconnect and have a wonderful I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I know I I know I know I know I know I know .

Speaker Change: Thank you for watching!

Speaker Change #100: and many more.

Speaker Change #100: [inaudible]

Speaker Change #100: Thank you for watching!

Operator: . Thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time, thank you very much for your time.

Speaker Change #100: Thank you for watching!