Lantheus Holdings, Inc. Q1 FY2025 Earnings Call

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

Thank you. Good morning. With me today are Brian Markison, our CEO; Paul Blanchfield, our President; Bob Marshall, our CFO; and Amanda Morgan, our Chief Commercial Officer. We will begin with prepared remarks and then take your questions. This morning, we issued a press release which was furnished to the SEC under Form 8-K, reporting our first quarter 2025 results. The release and today’s slide presentation are available in the Investor section of our website. Any comments made could include forward-looking statements. Actual results may differ materially from these statements due to a variety of risks and uncertainties which are detailed in our SEC filings. Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investor section of our website. I will now turn the call over to our CEO, Brian.

Thank you, Mark, and good morning, everyone. Before I dive into my prepared remarks, I’d like to note our press release from last evening where we announced our plans to divest our SPECT business to SHINE Technologies. I would like to extend my heartfelt thanks to the incredible team that has been with the company from the very beginning and has played a vital role in shaping Lantheus into what it is today. In 2025, we’ve been laying the foundation for the next chapter of our business. We announced two acquisitions in the first quarter, Evergreen Theragnostics and Life Molecular Imaging, both designed to fuel our radiopharmaceutical leadership and sustain long-term growth. We closed on Evergreen in early April and expect to close the LMI acquisition in the coming weeks. As I mentioned, we also announced an agreement to divest our SPECT business. Collectively, these transactions accomplish a number of objectives. First, they add immediate revenue growth drivers that complement our business and diversify our revenue. Second, they add exciting programs in late- and early-stage development. Third, they add key capabilities, both people and infrastructure, that will enable the company to deliver novel programs from bench to clinic and ultimately to patients. Finally, they streamline and help focus our organization. This year, we are focused on integrating the Evergreen and LMI businesses and finalizing the divestment of our SPECT business. With our strong cash position and disciplined capital allocation strategy, we are well positioned to continue investing in our capabilities, advancing and selectively expanding our pipeline, and returning value to shareholders. With that, I’ll turn the call over to Paul to give an operational and strategic update.

Thank you, Brian. I’m pleased to share more about our recent developments. We believe the acquisitions of Evergreen and LMI will strengthen our radiodiagnostic and therapeutic capabilities while expanding our commercial portfolio and pipeline, ultimately enhancing our long-term growth potential. Evergreen enhances our capabilities across the entire value chain with scalable radiotherapeutic manufacturing infrastructure, an early-stage discovery engine, and an expanded pipeline, including OCTEVY, a registrational stage PET imaging agent targeting neuroendocrine tumors. Evergreen’s Springfield, New Jersey site and dedicated team will enable us to manufacture our own clinical stage radiotherapeutics, improve development timelines, and accelerate our pipeline. We also expect to make further investments in this facility and team to enhance our radiodiagnostic expertise and process development capabilities. LMI will provide Lantheus with a commercial radiodiagnostic Alzheimer’s franchise, a talented team, and NEURACEQ, a globally approved F-18 PET imaging agent used to detect beta-amyloid plaques in patients at risk of Alzheimer’s disease. We believe that LMI and Lantheus’s combined capabilities will support NEURACEQ’s continued growth in the beta-amyloid radiodiagnostic market and create a scalable and differentiated platform from which to launch all of our Alzheimer’s disease PET imaging agents. Alzheimer’s disease affects over 50 million people globally and remains an area of significant unmet need for patients, caregivers, providers, and broader society. We believe the Alzheimer’s radiodiagnostic market is poised for significant growth driven by currently approved therapeutics and over 100 candidates in clinical development targeting beta-amyloid or tau. When approved, these therapeutics are expected to increase the need for accurate and timely diagnosis, staging, patient selection, and monitoring of disease, areas we believe PET imaging is uniquely positioned to address. As such, we believe the U.S. AD Radiodiagnostics total addressable market could grow to more than $1.5 billion by the end of the decade and $2.5 billion by the mid-2030s. We are positioning ourselves to lead in this market with the potential for multiple differentiated PET agents targeting beta-amyloid or tau. Finally, yesterday, we announced an agreement to divest our SPECT business to SHINE Technologies. The SPECT business has been a foundational part of Lantheus’ leadership in nuclear medicine dating back to our days as New England Nuclear. We believe now is the right time to divest the SPECT business as we continue to focus on PET radiodiagnostics, microbubbles, and radiotherapeutic agents. SHINE’s isotope production capabilities make them a natural owner of this business, and they are committed to investing in and growing the business. We are grateful to the generations of colleagues who have brought our SPECT products to patients and are confident that the business and these colleagues will be in good hands with SHINE. We expect the transaction to close by the end of this year. With that, I’ll turn the call over to Amanda to provide a commercial update.

Thank you, Paul. I’m pleased to share the progress on our commercial portfolio. PYLARIFY sales for the first quarter were $258 million, with year-over-year volume growth offset by a low-single-digit decline in net price. We have successfully executed our strategy to secure the vast majority of PYLARIFY revenue through Strategic Partnerships with key hospitals and freestanding imaging centers. However, with the expiry of PYLARIFY's pass-through status and the implementation of mean unit cost payment for Medicare fee-for-service and the hospital outpatient setting, we did experience what we believe will be temporal competitive disruption among smaller, non-contracted sites. We plan to maintain our market leadership and will continue to work through these competitive pressures and grow volume and revenue in 2025. We will achieve this by broadening our contracting efforts while maintaining our pricing premium, expanding product availability in both earlier and later calibration times, educating on PYLARIFY’s clinical and commercial differentiation, and continuing to provide superior customer service. By 2030, we anticipate the PSMA PET addressable market will exceed $3.5 billion. The key drivers for this growth include the rising incidence and prevalence of the disease, continued conversion of conventional imaging, broader adoption among lower-risk patients, and the expansion of the PSMA-targeted radioligand therapies. We are pleased with the FDA’s recent approval of Pluvicto in the pre-chemotherapy mCRPC setting, as supported by the PSMAfore trial results, and expect this indication to further increase demand for PSMA PET imaging agents such as PYLARIFY. Notably, Pluvicto’s label now references the use of any FDA-approved PSMA PET product for patient selection. We believe there is a market expansion opportunity with our Phase 4 MIRROR study in patients with favorable intermediate-risk disease. With this data, our goal is to support future updates to NCCN and SNMMI guidelines to include the use of PSMA PET with PYLARIFY in this patient population, which could, in turn, expand the addressable market. DEFINITY remains the number one utilized ultrasound-enhancing agent with more than 20 years in the market and more than 20 million echocardiograms performed. In the first quarter of 2025, DEFINITY achieved approximately $79 million in sales, even with the return of competitive supply to the U.S. market. With our two number one imaging agents in PYLARIFY and DEFINITY, we are pleased to continue to serve as the partner of choice for our customers and look forward to the expansion of these relationships with the potential to add NEURACEQ in 2025, PNT2003, OCTEVY, and MK-6240 in 2026, as well as NAV-4694 in 2027. I will now turn it back to Brian to discuss our development pipeline.

Thank you, Amanda. We continue to advance our diverse, catalyst-rich pipeline with a focus on assets that are first or best-in-class in oncology, neurology, and cardiology. We believe our neurology pipeline of MK-6240 and NAV, combined with LMI’s NEURACEQ and PI-2620, positions us well to support the diagnosis, staging, patient selection of therapy, and monitoring of patients with Alzheimer’s disease. Our portfolios are highly complementary, and we believe LMI’s established commercial franchise provides a platform that will enable us to quickly realize the value of these assets. We recently announced that MK-6240, our next-generation tau imaging agent, met its primary endpoints in two pivotal studies assessing its sensitivity and specificity. We plan to submit a new drug application to the FDA in the third quarter of this year, and if approved, look forward to bringing MK-6240 to the market in 2026. Additionally, we remain on track to submit an NDA for NAV in 2026 as well. We have strengthened our oncology portfolio with the acquisition of Evergreen’s OCTEVY, which has the potential to create a theranostic pair with PNT2003, a registrational stage radio-equivalent therapeutic candidate for SSTR-positive gastroenteropancreatic neuroendocrine tumors or GEP-NETs. PNT2003, which has the potential to be the first FDA-approved radio-equivalent to LUTATHERA, is planned to launch in 2026, pending FDA approval and positive resolution to patent litigation, which is ongoing. Turning to some of our earlier oncology assets, LNTH-2503, which was acquired with Evergreen, is a potentially best and first-in-class theranostic pair targeting the CCK2R receptor. We currently have the diagnostic agent paired with gallium-68 in Phase 2 development, and we are excited to report the Phase 1 therapeutic trial with lutetium-177 is now recruiting patients in Europe. Our theranostic pair for LNTH-2401 and LNTH-2402 includes a gallium-68 imaging agent with a lutetium therapeutic agent targeting GRPR, which is a receptor highly expressed in several tumor types, particularly in prostate cancer. We believe there is a potential for this asset to serve independently and in combination with PSMA since GRPR and PSMA expression are frequently negatively correlated. It is important to note that in early disease, GRPR expression is quite similar to PSMA. The diagnostic agent 2401 is already in Phase 2 development, and we remain on track to submit an IND for 2402, the therapeutic candidate. LNTH-2403 is a preclinical therapeutic agent targeting LLRC15, which is strongly expressed on multiple malignancies, including head and neck, breast, lung, and pancreatic cancers. We are initially focusing on osteosarcoma, for which the FDA has granted both orphan drug and rare pediatric disease designations. Osteosarcoma is a malignant bone tumor that primarily develops in children and teenagers and is the most common childhood bone cancer with around 1,000 new cases diagnosed annually in the U.S. Finally, for PNT2002, the Phase 3 SPLASH study recently reached 100% of pre-specified overall survival events. The results were comparable to the previously purported 46% and 75% readouts and remain confounded by patient crossover within the study. While we continue to work closely with our partner, Eli Lilly, to review the full dataset, we do not plan to pursue an NDA or further invest in this asset at this time. I will now turn the call over to Bob.

Thank you, Brian, and good morning, everyone. I will provide highlights of the first quarter 2025 financials, focusing on adjusted results with comparisons to the prior year quarter, unless otherwise noted. Turning to the details, consolidated net revenue for the first quarter was $372.8 million, an increase of 0.8%. Radiopharmaceutical Oncology, currently PYLARIFY, contributed $257.7 million of sales flat with the prior year. Precision Diagnostics revenue of $104.4 million was flat year-over-year. Highlights include DEFINITY at $79.2 million, 3.5% higher, along with TechneLite revenue of $19.7 million, down 9.2% due to a brief supply issue in March now resolved. Lastly, Strategic Partnerships and Other revenue was $10.7 million, up 65.1% due to the continued contribution from use of our investigational asset MK-6240 in third-party clinical trials, up 10.4%, as well as from the recognition of the first sale milestone from Mercado of $2 million. Gross profit margin for the first quarter was 67%, a decrease of 180 basis points. The decrease is attributed to impacts at margin stemming from our strategic partnership contracting initiatives, the animalization of 2024 PMF network and related supply additions, unfavorable PMF network dose volume mix, as well as underabsorption of overhead due to the supply shortage late in the quarter, partially offset by favorable volumes for PYLARIFY and DEFINITY. Operating expenses at 28.3% of net revenue were 147 basis points higher than the prior year rate and slightly higher than the previously guided spending levels. As noted earlier this year, increases in operating expenses reflect investments made to support several growth and efficiency initiatives, notably research and development increased 251 basis points to 7.3% of net revenue in support of a number of late- and early-stage development programs. It is worth noting that the company expensed nearly $3 million of business development expenses, largely legal and other third-party, in support of yesterday’s announced divestiture of our SPECT business to SHINE. We do not adjust our management P&L for transaction-related expenses when the deal itself is not signed within the same quarter as incurred, thereby inflating current period operating expenses. Operating profit for the quarter was $144.3 million, a decrease of 7.1%. Other income and expense of $4.6 million of income is a result of interest income offset in part by interest expense on our existing debt. Total adjustments in the quarter were $52.3 million of expense before taxes. Of this amount, $21.2 million and $8 million of expense is associated with non-cash stock and incentive plans and acquired intangible amortization, respectively. $14.9 million is a result of unrealized losses tied to our equity investments in perspective and other companies. $5.4 million is related to milestones, and the remainder relating to acquisition, integration, and other non-recurring expenses. Our effective tax rate was 26.5%. The resulting GAAP net income for the first quarter was $72.9 million and $109.5 million on an adjusted basis, a decrease of 7.5%. GAAP fully diluted earnings per share for the first quarter were $1.02 and $1.53 on an adjusted basis, a decrease of 9.5%. Now, during the cash flow, first quarter operating cash flow totaled $107.6 million, down $19.7 million from Q1 last year, as working capital, particularly DPO metrics, have normalized from the post-SAP implementation environment. Capital expenditures totaled $8.7 million, $400,000 lower. Free cash flow, which we define as operating cash less capital expenditures, was $98.8 million. $20.1 million lower for the previously described reasons. During the quarter, the company invested an additional $5 million in RAD equity and deposited $50 million related to the Evergreen acquisition, which closed on April 1st. Taken together, cash and cash equivalents net of restricted cash were $938.5 million at the end of Q1. We have access to our $750 million undrawn bank revolver and are comfortable with our very strong liquidity position. We are actively monitoring the recent tariff activity and are working closely with our partners and industry groups to assess any potential impact and advocate for the continued exceptions granted to pharmaceuticals and radioisotopes. This is an evolving situation, but at this juncture, direct impact to our business remains minimal. Turning now to our updated interim corporate guidance for the full year 2025. In anticipation of closing the LMI transaction in the next week, we are providing an interim view to business, but we’ll update a consolidated view of 2025 after we have closed that transaction. That said, our view of PYLARIFY performance for the balance of the year has come into sharper focus. We are updating the implicit PYLARIFY range embedded in the previously guided standalone Lantheus full-year view of revenue. That said, we are shifting our implicit PYLARIFY year-over-year range to flat-to-low single-digit percent growth for the full year versus our prior view of low-single-digit to mid-single-digit growth. Commentary on all other Lantheus products remains the same. Evergreen adds approximately $10 million of revenue for the balance of the year and reduces adjusted EPS by approximately $0.25, in line with prior dilution guidance. Taken together, revenue is now expected to be $1.55 billion to $1.585 billion, ahead of adding in the potential LMI revenue contribution, demonstrating the power of our strategic intent to diversify revenue streams. For adjusted EPS modeling purposes, we continue to expect low-single-digit dilution from the combined addition of Evergreen and LMI, assuming a consistent share count. The divestiture of the SPECT business should not have any impact on 2025 revenue or earnings, as it is expected to close toward the end of the year. But this strategic move should unlock consolidated revenue growth and gross margin expansion in the future. Additionally, the company advanced several R&D projects with positive ROI metrics that were not previously considered in the prior guidance. Therefore, R&D should be approximately 7.5% of revenue, up approximately 100 basis points for the full year. For now, by only incorporating our PYLARIFY update R&D investments and including Evergreen, we now see adjusted EPS in the range of $6.60 to $6.70 versus the prior guidance of $7 and $7.20. We do expect LMI's contribution to the company to be accretive to revenue and earnings immediately. We look forward to providing more specifics after the LMI closing. With that, I’ll turn the call back over to Brian.

Thank you, Bob. We are diversifying our revenues and setting up the business for continued long-term growth. We are driving both commercial and clinical success through our leading diagnostic agents and our diversified pipeline. We are committed to advancing our position as the leading radiopharmaceutical-focused company with both new clinical developments and inorganic growth acquisitions, remaining the partner of choice for nuclear medicine departments and freestanding imaging centers, delivering sustainable growth, creating long-term value for our shareholders, and bringing innovative products to patients who need them. With that, we are ready to take your questions. Operator, please proceed.

Our first question comes from Anthony Petrone from Mizuho Financial Group.

Thanks, and good morning, everyone. Hope everyone’s well. Maybe start with PYLARIFY trends in the quarter. Obviously, good detail in the prepared remarks, but maybe just a little bit more on the competitive dynamics you’re seeing out there. Certainly by our math, you’re looking at a fair amount of share shift here through the March ending quarter, so a little bit on the PYLARIFY competitive dynamics, and I’ll have one quick follow-up on gross margin.

Okay. Anthony, thanks. We got your questions. I think Paul will lead it off on the reply. Paul?

Yeah. Thanks, Anthony. Good morning. So, I think in the first quarter, I’ll add to what we and Amanda provided in the prepared remarks. First, we were successful in securing the vast majority of our revenues through the Strategic Partnerships. Those, as we’ve stated before, have largely been with our longstanding and established hospitals and freestanding imaging centers, many of them who have been with us since launch. Those partnerships were key to stabilizing the business, especially amidst the transition to mean unit cost from a Medicare fee-for-service reimbursement perspective. They’re also going to serve us incredibly well as we launch a broader portfolio. In the quarter, we did experience short-term competitive disruption, specifically among the smaller non-contracted sites due to MUC-related reimbursement, price, as well as product availability. These smaller sites have been more recent adopters of PSMA PET imaging, and as a result, they have been outpacing the broader PSMA PET market growth. We continue to work through competitive pressures and some of these market dynamics, but we do plan to maintain our market leadership to grow volumes and revenues, and to expand our contracting efforts with some of these higher growth later adopter accounts, as well as expanding product availability to ensure that we can continue to meet the growth and ensure our growth grows closer to that of the broader market.

That’s helpful. Please continue.

Go ahead. Your follow-up question.

All good. Thanks, Brian. Maybe just the SPECT sale caught us a little bit by surprise, so maybe just quickly on the rationale to exit SPECT now. And again, on the positive end here, I know you had the MK-6240 headline readout, which was positive. When can we expect to see that data? Thanks.

Yeah. Anthony, thank you. Well, on the MK question on the readout of the data, right now, we’re all hands on deck to file the new drug application, and then in the not-too-distant future, we’re going to be happy to showcase the data because it is quite positive, which gives us a lot of confidence going into the submission. On the sale of the SPECT business, I think it’s important to note that if you look at where we’re going, our recent acquisitions, our pipeline, molecular imaging, theranostic pairs, radioligand therapies, the SPECT business has been a big anchor for us, but not a core to our future growth. So what we’re doing is we’re looking to streamline and unlock value, partner that business with a party like SHINE Technologies that is willing to invest further in it. We will also remain very close to SHINE as they proceed and grow that business. Bob, do you want to add to that a little bit?

Yeah. I guess what I would add is maybe sort of like how you think about what this means to the business in terms of the total is about $115 million to $120 million of revenue. It’s been a very stable contributor. So that’s what I mean when, as a growth factor, when that comes out of the business, it sort of helps to accelerate the balance of our portfolio, which we do think can continue to grow and expand. The gross margin implications, it’s a couple of hundred basis points of benefit as we look forward because the business has a gross margin profile that is much below the company’s current average. So again, as Brian noted, this does help to unlock additional value while that business then has the potential to grow in SHINE’s hands.

Thank you. One moment for our next question. Our next question comes in the line of Roanna Ruiz from Leerink Partners.

Hey. Good morning, everyone. So I was curious, I noticed you tightened your fiscal 2025 guidance a bit. Could you talk a bit more about what drivers could put you on either the low end or the high end of that guidance by year-end? And just tagging on a quick SPECT divestiture question, I assume it probably frees up certain resources and was curious, where would you pivot those in terms of contributing to the rest of the commercial or development pipeline?

Yeah. Roanna, could you do me a favor and repeat the second half of that question? I’m not sure I completely got it.

Oh! Sure. With the SPECT business divestiture, I was assuming that you were going to free up certain resources or capital, things like that. Where would you want to use those in terms of either the pipeline or commercial efforts?

Got it. I appreciate the clarification. Bob, you want to start off and then Paul, we’ll pick it up?

Yeah. I’ll take it from a guidance perspective. So Roanna, appreciate the question. We’ve narrowed the range, but we’re now coalescing around the bottom half of the prior range and it really is about PYLARIFY. So we’re still staying in basically what we had previously guided. It’s just that Q1 was extremely informative on how the competitive environment would manage PYLARIFY as we came off pass-through. Our original view actually was a pretty wide range that contemplated a range of outcomes with the first half being flattish and then with low-single to mid-single-digit to mid-single to high-single-digit type of an outcome. So all we’ve done is sort of narrow this range to be at the bottom. So we’re taking the bottom half of that original range. The key thing here, though, is we do still expect healthy dose volumes throughout the balance of the year, and that is why we landed where we did.

And Roanna, maybe on your SPECT question, I think we would characterize it really as a couple of things, right? And I’ll expand on kind of what Brian and Bob said earlier. But one, this is really about organizational focus. We are ruthlessly prioritizing key growth areas like PET radiodiagnostics and radiotherapeutics, as well as our DEFINITY microbubbles as future growth drivers. So I think it just enables the broader organization to really focus its efforts there. There has naturally been limited investment in the development programs of SPECT. That business is many decades mature. And similarly, from a commercial perspective, it’s got relatively little complexity working with just a few key partners. We’re incredibly excited for the SHINE team to take on those capabilities and to further invest in that business. And so this is really around who’s the best owner and what our organizational focus needs to be to drive continued growth and value creation. And then lastly, there are the financial benefits that Bob mentioned of just, it’s been a relatively stable business with margins below the company average. And so this really allows us to unlock the full potential of our financial capabilities and then focus the organization wholeheartedly on our future in PET diagnostics, radiotherapeutics, and microbubbles.

Yeah. And Roanna, I think it’s important to note that a number of our colleagues will be going with the SPECT business to SHINE. So if you think about the bigger picture strategically, we’re onboarding a team from Evergreen from Life Molecular Imaging with phenomenal capability in molecular imaging and radiodiagnostics and therapeutics, and quite frankly, a legacy business that we’re not really nurturing and paying that much attention to as we grow the rest of the business is essentially coming out. So moving parts, some leaving, unfortunately, and some coming in, fortunately, and it’s really a natural transition of this business all in line with our strategic intent.

Thank you. 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 wanted to maybe just ask on the acquisition, just looking at 2026, because that’s going to be the first full year where these acquisitions will be in there. I think your prior guidance had assumed or your prior comments was low-single-digit percent dilution from the combination of LMI and Evergreen. Is that still the right way to think about it? And then also, I think last call, you had said you expect 2026, with the acquisitions, to be a double-digit revenue growth potential year. Is that still in the cards as well? Thank you.

Yes. Before, Rich, thanks for the question. That is definitely in the cards and I appreciate you asking. And then Bob, you want to take the rest of the answer?

Yeah. So exactly. The guide for the dilution was low-single-digit, but a combination of both Evergreen and LMI. That guide also contemplated sort of mid-year sort of closing on the deals. We closed early on Evergreen and expect to close on LMI in the next week. That all being said, yes, the $0.25 that they’ve given to the midpoint of what we had said previously, which at $7.10, is mid-single-digit. That does include about 50 basis points of additional interest income lost. But at the same time, I do fully expect that we would get to low-single-digit dilution off that $7.10 number once we’ve closed on LMI as well. And then update our guidance after we’ve closed to take that into consideration, both revenue and earnings.

Thank you. One moment for our next question. Our next question comes from the line of Matt Taylor from Jefferies.

Hi. Thank you for taking the question. So I wanted to follow up on some commentary from last quarter. You had talked about in 2026, with the combination of your base business and the acquisition of Evergreen and LMI, being able to sustainably grow in the double digits. And I guess I just wondered if there’s any change to that thinking, positive or negative, and maybe you could give us any color around the quantum within the double digits you could grow beyond this year?

Yeah. Thanks, Matt. I appreciate the question. On the quantum, I think it’s a little early on that front, but on double digits, yeah. So let me tell you what we’re looking at, right? It’s the potential launch of OCTEVY with combined potential launch of 2003, the potential launch of MK-6240, the full animalization of NEURACEQ and our plans to grow it. But more importantly, perhaps, is the anchored growth with PYLARIFY and DEFINITY, which we plan to continue. Guys, did I leave anything out?

No.

So that’s what we’re looking at. That’s what we’re excited about. And that’s anchoring our double-digit growth for 2026.

Thank you. One moment for our next question. Our next question comes from the line of Paul Choi from Goldman Sachs.

Good morning. This is Daniel on for Paul. We have two questions. First is like, are you still thinking that there’s a chance that part of this PYLARIFY revenue would switch to ASP pricing this year? And what about the trends for 2026 and beyond? The second question is that after the LMI deal closed, what’s the current trend of the PET scan market growth in the Alzheimer’s scan market? Thank you.

Okay. So on which one do you want to take first, the Alzheimer’s or the PYLARIFY?

Why don’t I touch on the PYLARIFY, why don’t I touch on the PET scan Alzheimer’s, and then Amanda can maybe touch on the 2025 and future long-term growth of the PSMA PET market.

All right. And before you do that, we are in constant discussions with CMS, and we are working with them, and could ASP emerge rather soon? Yes. But, look, it’s a little murky down there, so I can’t really predict the future. Amanda, the team are really working hard on it. Amanda, you want to comment on that briefly, and then we’ll switch it over to Paul?

We are encouraged by our conversations. It is an ongoing discussion. I can share that the team we have been communicating with at CMS remains the same, and so far, we have not observed any impact from the recent changes in administration.

Great. All right. Paul?

So, maybe just long-term PYLARIFY and the PSMA market, I think we remain very excited about the long-term potential. We’ve highlighted our addressable market potential in 2030 as being $3.5 billion. I think that continues to come into greater focus and affirmation with the Pluvicto data as an example, and their approval with PSMAfore. And so, I think, we’re very excited about the long-term potential of PSMA PET. From a pricing perspective, near-term, Strategic Partnerships are going to anniversary largely in the first half of this year, which will set us up for more support in the long-term growth. And so, I think we remain optimistic about the overall PSMA PET market and the long-term potential for PYLARIFY, especially as we broaden the portfolio to be the go-to partner for hospitals and freestanding imaging centers. We have the potential to have the largest and broadest innovative portfolio to work with those sites to expand our Strategic Partnerships and continue to support that continued growth, and that includes Alzheimer’s. Clearly, Life Molecular remains a separate organization under Life Healthcare today, but just monitoring the trends of overall claims data as a result of Alzheimer’s scans, specifically for beta amyloid, but increasingly for tau, we see very robust growth in that marketplace. And when we think combining the terrific team and capabilities of LMI with that of Lantheus and our deep F-18 expertise and experience with customers, we’re very optimistic about the opportunity in Alzheimer’s with NEURACEQ, as well as MK-6240, now 4694, and PI-2620, to have a broad, deep portfolio in Alzheimer’s that can be a very meaningful franchise for us.

Thank you. One moment for our next question. Our next question comes from the line of Larry Solow from CJS Securities, Inc.

Good morning. Thanks for taking the question. First question, I’m just on the gross margin and a little bit of higher cost goods there. You mentioned the issue with TechneLite. Was gross margin impacted at all just by the, I guess, the overall price discounting on PYLARIFY, and is PYLARIFY pricing kind of in line with how you expect it to be?

Yes. The explanation for the quarter, especially on a year-over-year basis, highlighted the impact on margins from Strategic Partnerships among other factors. There were several additional cost factors I mentioned. Compared to our original expectations of 67.5 to 68, the main reasons for the shortfall came down to a couple of different issues. Freight costs were higher, and there was also a mix in the dose volume within our network. Depending on where PYLARIFY is distributed, the mixes are not all the same, which affected expectations. However, regarding pricing, we still maintain a premium over our competitors, which aligns with our expectations.

Thank you. One moment for our next question. Our next question comes from the line of Yuan Zhi from B. Riley.

Oh! Good morning. Thank you for taking our questions. Maybe to answer this question a bit differently, can you please comment more on the effect of this long-term contract you find for clients in that bucket? Do they grow in volume of PYLARIFY faster than others? Then if we compare the growth rate across academic centers and the community centers, is there a difference in terms of growth and market penetration? Thank you.

Thank you for the question, Yuan. It's a very good one. There is definitely a difference in growth and utilization across the marketplace. We are approaching four years since the approval and launch of our product. We observed early adoption from leading academics and large-scale imaging centers. The usage rates of PYLARIFY and, frankly, other PET-CT agents among these early adopters are significantly higher compared to other parts of the market. This has sometimes resulted in longer patient wait times. Meanwhile, smaller non-contracted accounts are experiencing faster growth than the overall market as they are later adopters and earlier in their adoption curves. We are seeing a clear difference in overall utilization. Our strategy has been to secure the majority of PYLARIFY revenues through Strategic Partnerships, and we believe we have successfully achieved that. Now, we are increasingly focusing on smaller non-contracted sites that offer more immediate growth opportunities. This approach revolves around our mix and our strong commitment to securing the majority of the business while evolving to expand our contracts with smaller accounts, thus improving our delivery times to match growth in those locations. That is what we are actively working on now.

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 discuss how you view the long-term opportunity for the GRPR targeting imaging and therapy in prostate cancer? Specifically, I’m wondering if there’s expected clinical value for imaging GRPR outside of enabling the therapeutic or if that’s the key feature there. And if you’d expect therapeutic use ultimately to be in the post-PSMA setting.

Great question. Let me start sort of at the beginning. In early prostate carcinoma, GRPR expression is quite avid and quite similar to PSMA expression. And what we find fascinating about the agent or the target is where one overexpresses, the other could be underexpressing. So in other words, if you get into later lines of therapy, if PSMA expression is down or depressed, GRPR expression could be quite high, and there could be a fair amount of avidity there for a radial ligand therapy. The gallium diagnostic agent is in Phase 2 right now, and we’re exploring separate fast-track opportunities to see if we can bring that to the market earlier. I think there will be an interesting role for the imaging agent in and apart from the therapeutic. And I think with the therapeutic, we’re focused right now on getting the IND filed and also getting into the clinic as soon as practical in phase one. And we think there’s going to be a very interesting role because ultimately these radioligand therapies are not going to be used as single agents. They will be used in combination like any other therapeutic modality in oncology, and we think there’ll be additives. So there could be a very interesting role both in very early-, mid-, and late-term prostate cancer disease for the therapy and also for the diagnostic.

Thank you. One moment for our next question. Our next question comes from the line of Kemp Dolliver from Brookline Capital Markets.

Hi. Thank you. On the smaller accounts in the market for PYLARIFY, are these accounts that are operating essentially on a spot basis or are they contracted with others? I’m trying to reconcile your position as a premium price product with what looks like a customer base that might have a commodity mindset. So can you reconcile that for me?

Yeah. I think we’re looking at it a little bit differently. I think as we have grown our business and matched that with our growing network, we have 63 PMFs up and running in the country, and our strategic contracts were designed to partner us for the long-term with our highest volume early adopters. And I think what we’re seeing is the smaller accounts that now have some capacity were not initially our early focus as we were dealing with the major institutions. So, Amanda, do you want to expand on that a little bit?

Yeah. No. Thanks, Brian. That’s exactly right. As we continue to evolve, as Paul shared in his prepared remarks, we are continuing to grow and expand our product availability. And that’ll be through our earlier and later calibration times. That will enable us to not only partner, as Brian said, with our largest strategic accounts, but also partner with the smaller accounts or those later adopters that are continuing to adopt PSMA PETs.

Thank you. One moment for our next question. Our next question comes from the line of Frances Duval from TD Securities.

Hi. This is Frances on for Tara. Can you elaborate on the extent of the MUC-based pricing impacts on revenue this quarter compared to other factors like the net pricing impact? And are you still guiding to the MUC pricing affecting only about 10% of total patients?

Thanks for the question. So, the MUC-based pricing remains impacting about 20% of patients. That is the overlap or intersection, I should say, between Medicare fee-for-service relative to Medicare Advantage or commercial payers, and then in the hospital outpatient setting. So, that’s still around 20% of patients overall when you look at that. I would say, I think when we look at the quarter and some of the dynamics, we looked at MUC pricing, we looked at competitive pricing, as well as product availability in some cases. Fundamentally, I think it’s hard to break down into those three because they ultimately all intersect on the impact of customers, as well as the adoption or growth curves in there. And so, I think they all had a bit of an issue. I would say MUC is likely more of a transitory impact as customers understand based on the payment timing of claims from Medicare. It does take them a little bit of time to understand what that looks like. We think sites have a pretty good understanding of their book of business, and that should stabilize over time. And then we continue differentiation and availability of PYLARIFY, plus our broadening portfolio will support our continued growth.

Thank you. One moment for our next question. Our next question comes from the line of Andy Hsieh from William Blair.

Oh! Great. Thanks for taking our question. So, we’re curious about your long-term view on Alzheimer’s diagnostic market, specifically pertaining to the encroachment of serum-based biomarkers for diagnostic purposes. So, Biogen on the first quarter call, they mentioned for the potential for blood-based markers to potentially supplant the need for PET scan. So, I’m just curious if you can comment on that and potentially provide your view there. And a quick follow-up for your 2030 PYLARIFY revenue guidance. I understand that the PSMA edition opportunity is included, and that’s reading out later this year, but could you help us understand the growth potential for PSMA-DC and some of the FPM-225 assets that are moving into earlier lines and recently moved to Phase 3 trials? Thank you.

All right. So, I’ll kick it off with the Alzheimer’s answer and turn it over to Paul. First, on serology, blood-based biomarkers, I think they’re very important. And I think if you look at the prostate market, you have PSA as a legitimate marker for detection, follow-up, et cetera, for disease. And I would think in AD or Alzheimer’s disease, you’d see a similar pattern, hopefully, where people will get screened with serology and then become candidates for a PET scan or molecular imaging. I think when you compare them, there is no comparison, right? Molecular imaging gives you quantification, it gives you geography, it gives you correlation to treatment outcome and effect, so none of the serology markers can actually do that, they’re not that sensitive, nor are they specific. So if you’re looking at specific regions of the brain, for example, with MK-6240, and looking at longitudinal follow-up, you’re looking at what parts of the brain are mostly affected by the NFTs, serology can never do that, at least in my current lifetime, I think. So while I appreciate comments from others, I think maybe they’re not totally informed, but there’s still comparison with molecular imaging and serology. I think serology is a great tool, it’s cost-effective, it should be used as a screening mechanism, but if you want to know what’s happening inside the brain with Alzheimer’s dementia, add geography, follow-up, effects of treatment, you really need a molecular imaging scan with beta amyloid and tau.

Maybe I’ll just add on that and then I’ll pivot to the PYLARIFY piece. I 100% agree with what Brian just said. I guess I would just add, Andy, when you look at payers looking at roughly mid-$30,000 a year therapeutic costs, over multiple years, it’s not hard to imagine that as a payer and a physician looks at saying, putting on someone therapy that may cost $100,000 over three years, the desire to not just do a blood test, but to do a couple of $1,000 PET scan, that’s quite smart money to really understand the location and extent of disease and to effectively monitor that. And so we think there’s a symbiotic relationship between serological markers and imaging, the same way we see with PSA from a serological test and PSMA. I think on your earlier question on the PSMA therapeutic market, I think we may remain very encouraged on not only Novartis’ results with PSMAfore, but PSMAddition, which we’re optimistic about, as well as you said, there are dozens of candidates targeting PSMA from a radioligand therapy, and that really underscores our addressable market view where the scans associated with RLT could go from roughly $30,000, I believe, to almost $200,000 by the end of the decade. Current RLT patient selection only makes up single digits for PSMA PET use. We think that can expand not only with RLT, but also with antibody-drug conjugates and other therapeutics targeting PSMA. And so we think there’s continued benefit in the molecular imaging and the ability to find and follow disease, not only with PYLARIFY but with Alzheimer’s, as Brian mentioned.

Thank you. One moment for our next question. Our next question comes from the line of David Turkaly from Citizens JMP.

Hey. Good morning. There was lots of debate heading in about the changes that might happen with the reimbursement, and then, debates about sort of clients, customers switching. And it sounds like you’re saying these smaller centers maybe never used PYLARIFY and now you’re going to focus on them. But despite discussions of whether, like, these images, the scans might be apples-to-apples or not, we’re just curious, have you seen any evidence of switching, either at the large accounts or the small accounts, or even on a patient basis so far?

Yeah. I think, great question, and I appreciate it. I think if you look at our later adopters, smaller accounts, that we have not focused on, there has been a bit of what I would call stroke of the pen risk with them switching over to other agents, postromer or whatever, gallium. And we really focused, again, as we’ve said repeatedly, on our major accounts, right, those that have the majority of the volume, and also providing the most cutting-edge treatment. I think in the accounts, again, and we know where every dose is going, because our network partners are doing a great job delivering those doses, if they’re doing one or two scans a week, we’re not going to drop everything and go visit them. So naturally, they’re open to a dialogue about price, if that’s all that matters to them.

Thank you. One moment for our next question. Our next question comes from the line of John Vandermosten from Zacks.

Thank you and good morning. Two for me. First, under what conditions does it make sense to launch a generic competitor to a branded range of pharmaceuticals? And then second, what are some of the leading tau candidates in development that would benefit from MK-6240 and PI-2620?

Well, I think on the tau agents and also our NAV beta-amyloid, because of their greater sensitivity and specificity, any therapeutic candidate that’s in the clinic right now in trials will certainly benefit from better patient selection and follow-up. For example, both MK and NAV have the potential to detect very early centelloid count, and they’re actually, quite frankly, more sensitive than blood biomarkers. MK-6240 right now is in 103 approximately academic trials around the world, and over 15 sponsored trials with major pharma partners, and we’re working very closely with Janssen, Roche, and others, Merck, obviously, to name a few, to explore and help them clarify, detect, and put patients into clinical trials for their therapeutics. On the generic radio equivalent question, Paul would love to take that question.

Thanks for the question. So I’m launching our radio equivalent for 03. First and foremost, we always look at our appropriate return metrics to ensure that we’re going to generate a return north of our weighted average cost of capital, so we don’t just look for growth at any sort. We’re looking to ensure we have a positive financial return from those investments. When we look at the LUTATHERA opportunity, it is a sizable market. We’re pleased with their NETTER-2 results that we believe could make this a very sizable market, and so there’s certainly a role for additional products in that space. When we look at the ability to combine that with OCTEVY into a theranostic pair, we think that could be a meaningful addition to the marketplace, and in addition, it further expands our relationships with nuclear medicine departments and hospitals that are already using, say, PYLARIFY on their PET-CTs that may already be using NEURACEQ, and so we think this is a good opportunity, and we’re focused on bringing this to the market. But suffice it to say, we look very closely at the conditions at demand studies at market research to ensure that there is a positive return to the investments that we’re making, and we remain optimistic about that ability to bring OCTEVY and PNT-2003 as a theranostic-like pair next year.

Thank you. One moment for our next question. Our next question comes from the line of Richard Newitter from Truist Securities.

Hi. Thanks for the follow-up. I just wanted to go back to the PYLARIFY guidance. I’m sorry if you said this and I missed it. So, flat-to-low single digits for the full year. You had previously said flat first half 2025 year-over-year for PYLARIFY. Is that still intact and we just basically maybe a little less recovery in the back half to true it up or how should we think of any changes to cadence? Thank you.

No. Rich, that’s actually fairly astute. I mean, the range does provide, obviously, we delivered a flat, call it, first quarter. The math in and of itself, and you’re right, the flat-to-low single digits is for the full year. But so, from a Q2 perspective, I would anticipate sequential growth over Q1, but it does sort of imply, I’m not going to, again, I do expect gross dose volume to grow, but I don’t want to get into the pricing aspect of it. But what we are saying is the back half would still have a potential to be mid-single-digit in the back half. So, the language and the overall sentiment remains largely the same as we get into here, with the exception of maybe Q2, where we get into sort of the full effect of a year’s worth of contracting.

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