Earnings Call Transcript - LNTH Q3 2024

Operator, Operator

Good morning. Welcome to the Lantheus Third Quarter 2024 Conference Call. All lines have been placed on mute. This call is being recorded and a replay will be available in the Investors section of the company's website approximately 2 hours after the completion of the call and will be archived for at least 30 days. I'll now turn the call over to Mark Kinarney, Vice President of Investor Relations. Mark?

Mark Kinarney, Vice President of Investor Relations

Thank you. Good morning. 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 with prepared remarks and then open the call for Q&A. This morning, we issued a press release, which was furnished to the SEC under Form 8-K reporting our third quarter 2024 results. The release and today's slide presentation are in the Investors 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 Investors section of our website. I will now turn the call over to our CEO, Brian.

Brian Markison, CEO

Thank you, Mark, and good morning, everyone. Lantheus is the leading radiopharmaceutical-focused company with market-leading commercial products and a growing radiopharmaceutical pipeline targeting areas of significant unmet need. In the third quarter, we continued to enhance our leadership and create long-term sustainable growth through operational excellence, financial discipline, and prudent capital deployment. PYLARIFY, our PSMA PET imaging agent, delivered solid performance and remains on track to reach blockbuster status in 2024. And DEFINITY, our ultrasound enhancing agent, grew double-digits year-over-year. The continued success of these flagship diagnostic agents enables us to invest both organically and inorganically in our pipeline to extend our radiopharmaceutical leadership and create long-term value for shareholders. Before we move on to review the quarter, I'd like to commend CMS for its landmark decision to pay separately for specialized diagnostic radiopharmaceuticals beginning January 1, 2025. Under the hospital's outpatient prospective payment system or OPPS rule, this is a significant win for patient access and will ensure specialized diagnostic radiopharmaceuticals, including PYLARIFY are accessible for Medicare fee-for-service patients going forward, while also supporting long-term innovation in the field, including potentially MK-6240 and NAV-4694, our late-stage diagnostic product candidates for Alzheimer's disease. With that, I'll now turn the call over to Paul to provide an operational update.

Paul Blanchfield, President

Thank you, Brian. I'm pleased today to share progress on our commercial portfolio and pipeline. PYLARIFY sustained its clear market leadership as the number one PSMA PET imaging agent and remains on track to grow mid-20% year-over-year in 2024 and reach blockbuster status with more than $1 billion in sales. Net sales for the quarter were approximately $260 million, up 20% year-over-year and down 5% sequentially. Year-over-year growth was driven by increasing volumes offset slightly by net price as we secure strategic partnerships. Sequentially, the overwhelming majority of our existing accounts grew along with the PSMA PET market. The sequential revenue decline was driven by traditional third quarter seasonality, the net price impact of our recently secured strategic partnerships, as well as intentional trade-offs largely due to product availability. We continue to secure strategic partnerships with hospitals and freestanding imaging centers and believe our ability to maintain a price premium versus that of our competition reflects the commercial and clinical value that PYLARIFY provides to our customers. We believe we are well positioned to continue as the clear market leader in PSMA PET imaging and sustain PYLARIFY as a $1 billion franchise in 2025. As Brian mentioned, we are very pleased with CMS's updated rule recognizing the value and need for broad access to innovative diagnostic radiopharmaceuticals, including PYLARIFY. The rule provides separate payment for diagnostic radiopharmaceuticals with per-day costs greater than $630 following the expiry of transitional pass-through payment status. This represents significant progress for the field of diagnostic radiopharmaceuticals and, most importantly, sustained patient access. When implemented on January 1, 2025, CMS will maintain separate payment for PYLARIFY for the approximately 20% of patients with traditional Medicare fee-for-service insurance coverage who are treated in the hospital outpatient setting. PYLARIFY’s calendar year 2025 payment rate is found in Addendum B and is the same as its current payment rate. Note that this is in addition to the PET-CT procedural payment. We will be working with our customers to ensure they understand the final rule and recognize the value that PYLARIFY will continue to offer to the prostate cancer community. In our cardiology franchise, DEFINITY delivered third quarter net sales of $77 million, increasing 14% year-over-year. This was slightly higher than expected as competitor supply challenges led to higher market share in addition to high single-digit year-over-year market growth. DEFINITY's long-term success remains driven by its proven clinical and commercial value, longstanding track record of clinical application, and our ongoing operational excellence. We are also pleased by the FDA's approval of Flyrcado, also known by its generic name flurpiridaz, which we outlicensed to GE HealthCare in 2017. Flyrcado is an F-18 radio tracer approved for enhanced diagnosis of coronary artery disease. GE HealthCare has global commercialization rights and will lead the U.S. launch. Lantheus will receive royalties based on commercial milestones. We are also excited about MK-6240 and NAV-4694, our next-generation late-stage tau and beta-amyloid radio diagnostics and believe they can play a meaningful role in the diagnosis, staging, and monitoring of Alzheimer's disease. We expect these agents to be differentiated due to their high affinity and low off-target binding, potentially allowing for clearer images and earlier detection of disease. MK-6240 is a tau PET tracer for Alzheimer's disease currently utilized in 119 ongoing academic and industry-sponsored clinical trials. The dynamic range of MK-6240 may represent an advantage for longitudinal assessments of tau progression or treatment response in which detecting small changes can be critical. Tau pathology is closely linked to symptom severity, the rate of decline, and the development of declines in visuospatial and language functions. NAV-4694 has low non-specific white matter binding and high sensitivity, which suggests it could be useful for early detection of beta-amyloid accumulation. We believe earlier detection may aid in the identification of those Alzheimer’s patients most likely to realize a therapeutic benefit. Like MK-6240, NAV-4694 is currently being used in both academic and industry-sponsored studies. The National Institute on Aging and the Alzheimer's Association continues to update their guidelines as new therapeutic agents are approved and recently recommended both amyloid and tau PET imaging for diagnosis, staging, and treatment monitoring. Based on current analyst forecasts of therapeutic uptake and inferred scan volumes, we believe the U.S. market for Alzheimer's radio diagnostics has the potential to reach $1.5 billion by the end of the decade and $2.5 billion by the mid-2030s. We expect to submit NDAs for MK-6240 in 2025 and NAV-4694 in 2026 and are excited to leverage our commercial and operational excellence and growing neurological expertise to generate and meet the increasing demand for amyloid and tau PET imaging. Now I'll turn it back to Brian to discuss the rest of our pipeline.

Brian Markison, CEO

Thanks, Paul. Our pipeline is focused on assets that have the potential to deliver compelling new approaches for the diagnosis and treatment of disease areas with significant unmet need. Paul covered our neurology programs, so I'll discuss our oncology product candidates. Within our prostate cancer portfolio, PNT2002 is our investigational PSMA-targeted radiotherapeutic for the treatment of patients with metastatic castrate-resistant prostate cancer. We recently completed the second interim analysis for the Phase III registrational SPLASH study. The analysis was performed at 75% of protocol pre-specified overall survival or OS events. The results for both radiographic progression-free survival or RPFS and OS have not materially changed from the interim analysis that was performed at 46% of pre-specified OS events. We continue to review the data and perform additional subset analyses with our partner Eli Lilly that may be compelling to the FDA in preparation for an interaction on our path forward. As a reminder, the SPLASH study met its primary endpoint of RPFS, which was a meaningful and statistically significant improvement for the PNT2002 arm versus alternate RP or hormone therapy. The OS results in hazard ratio in the ITT population remain confounded by the overwhelming number of patients who crossed over to receive PNT2002. At the recent ESMO meeting, Dr. Oliver Sartor, lead SPLASH investigator and Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic, highlighted potential benefits of PNT2002 over hormone therapy switch. He discussed historical analysis and confidence intervals that were adjusted for the crossover population, noting the meaningful benefit from PNT2002 compared to the control arm. We have been focused on enhancing our pipeline by adding additional late-stage and early-stage assets that have the potential to address high unmet medical needs. We continue to work with our partners on our other clinical radiopharmaceutical programs. These include LNTH-2401 and 2402, our RM2 novel theranostic pair targeting gastro-releasing peptide receptor or GRPR for prostate, breast, and other cancers, and LNTH-2403, our LLRC15 targeted radio therapeutic for the treatment of osteosarcoma and other solid tumors. I'm particularly excited about these new oncology radiotherapy product candidates because they represent best-in-class constructs aimed at validated targets and have the potential to make a meaningful addition to the treatment options available for patients. I will now turn the call over to Bob.

Bob Marshall, CFO

Thank you, Brian. I will provide highlights of the third 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 third quarter was $378.7 million, an increase of 18.4%. Radiopharmaceutical oncology contributed $259.8 million of sales attributable to PYLARIFY, which was up 20.6%. The result is consistent with seasonal trends as well as the realization of our strategic partnership efforts amidst the competitive environment that Paul has discussed earlier. Precision diagnostic revenue of $103.7 million was 7.7% higher. Highlights include sales of DEFINITY at $77 million, 14.3% higher along with TechneLite revenue of $20.5 million, down 12% due to opportunistic sales in the prior year quarter, not repeated in this year's third quarter but rather in the second. Lastly, strategic partnerships and other revenue was $15.3 million, up 108.3% with the RELISTOR royalty stream completely annualized out of the result. Investigational usage of MK-6240 and NAV-4694 contributed $10 million and $2.3 million, respectively. Lastly, we recognized a milestone associated with an out-licensed asset from Progenics. Gross profit margin for the third quarter was 68.2%, an increase of 109 basis points. Favorable product mix on year-over-year strength of PYLARIFY and DEFINITY was offset in part by higher contracted material, freight, and overhead costs. Operating expenses at 24.6% of net revenue or 111 basis points higher than the prior year rate with a focus on increased R&D investment in support of our early- and late-stage assets. Sales and marketing efforts concentrated on PYLARIFY brand strategy, market research, and patient advocacy. ERP cost of ownership and optimization projects were the primary investment drivers for G&A. Operating profit for the quarter was $165.1 million, an increase of 18.3%. Net other income of $5.1 million as a result of nearly $10 million of interest income, offset in part by interest expense on our existing debt. Total adjustments in the quarter were $6 million of gain before taxes of this amount, $20.4 million and $11.9 million of expense is associated with non-cash stock and incentive plans and acquired intangible amortization, respectively. $37.3 million of net unrealized gain is tied to our equity investments in prospective and Radiopharm Theranostics with the remainder relating to acquisition, integration, and other non-recurring expenses. Our effective tax rate was 27.1%. The resulting GAAP-reported net income for the third quarter was $131 million and $124.1 million on an adjusted basis, an increase of 20.4%. The weighted average fully diluted share count outstanding was 73.1 million shares, slightly lower than previously guided. GAAP fully diluted earnings per share for the third quarter were $1.79 and $1.70 on an adjusted basis, an increase of 15.6%. Now turning to cash flow. Third quarter operating cash flow totaled $175.1 million, $58.3 million over prior year. Capital expenditures totaled $15.8 million, essentially flat with the prior year. Free cash flow, which we define as operating cash flow less capital expenditures, was $159.3 million, an increase of $57.1 million over the prior year. During the quarter, the company invested $47 million to acquire RM2 from Life Molecular as well as to in-license preclinical assets TROP2 and LRRC15 from Radiopharm Theranostics, and we made the tech transfer milestone payment related to the NAV-4694 asset. Concurrently, we invested $5 million in common shares at Radiopharm. Taken together, cash and cash equivalents, net of restricted cash now stands at $866.4 million. We also have access to our $350 million undrawn bank revolver adding to our strong liquidity position. We'd like to note that the company's 2027, $575 million convertible debt was reclassified to current liability as of September 30 as the company's stock price remained above the 130% of the conversion price threshold for more than 20 of the last 30 business days in the quarter in accordance with the bond's terms and conditions. The reclass will distort the period of working capital statistics. As I have noted, the company has more than sufficient liquidity and access to capital to manage the reclassification implications. Turning now to revenue and adjusted EPS guidance for the full year. We are narrowing our view of revenue to be in a range of $1.51 billion to $1.52 billion from the prior range of $1.5 billion to $1.52 billion. We continue to expect PYLARIFY to grow mid-20% over 2023 and as has been the case over the last couple of quarters. We are also narrowing our view of fully diluted adjusted earnings per share, which should now be in the range of $6.65 to $6.70 from the prior range of $6.60 to $6.70. This guide reflects timing differences between Q3 and Q4 within our operating expense lines. It also considers near-term financial impacts from organizational changes we took late last month to retool the company for future growth. This action will create an approximately $0.02 benefit in Q4 that we would expect to reverse in 2025 as we hire new talent with the skills and capabilities that align with our strategic direction. As has been the case all year, this estimate does not include any incremental investment for PNT2002 and nor any further business development that might be completed this year. With that, let me turn the call back over to Brian.

Brian Markison, CEO

Thank you, Bob. As the leading radiopharmaceutical-focused company, Lantheus has accomplished a lot and has an amazing future. We have leveraged the strength of our spec and DEFINITY franchises and successfully launched PYLARIFY to become the first PET radiopharmaceutical diagnostic blockbuster. With the success of our commercial products as a foundational engine, we have invested in our emerging R&D pipeline, expanding it to include new innovative product candidates, including radiotherapeutics and Alzheimer's radio diagnostics. We will continue to pursue thoughtful business development and M&A and intelligently deploy our capital. I'm proud to report that since the beginning of 2024, Lantheus commercial products have made a positive difference in the lives of over 5.2 million patients and their families. Lantheus remains at the forefront of radiopharmaceutical innovation and is positioned to deliver sustainable long-term growth and continued success in our endeavor to find, fight, and follow disease to deliver better patient outcomes. We look forward to delivering on these commitments. Operator, we're now ready to take questions. You can proceed.

Operator, Operator

Our first question comes from Roanna Ruiz with Leerink Partners.

Roanna Ruiz, Analyst

So a quick one for me, could you talk a bit more about the factors behind PYLARIFY's 3Q revenues? I appreciate that there was a bit of a seasonality impact and I was also curious if there are some changes or new strategic partnerships that might have come online? And could you help us think about how this should flow into the rest of the year?

Paul Blanchfield, President

Thanks, Roanna. So as we mentioned on the call, PYLARIFY grew 20% year-over-year in the third quarter and it does remain on track to grow mid-20% in 2024 and reach blockbuster status in line with our prior guidance, really being the first-ever PET imaging agent to reach blockbuster status. We did expect Q3 and Q4 PYLARIFY revenue split to favor Q4 on an absolute dollar basis. That's driven by the third quarter seasonality, not only from physician vacation schedules but also two significant holidays of July 4 and Labor Day during the quarter. In the quarter for PYLARIFY sequentially, the overwhelming majority of our accounts did grow on an absolute basis in line with the broader market. The sequential decline was really driven by, one, traditional third quarter seasonality with third quarter usually being the lightest sequential growth driver of the year. Also, the net price impact of our recently secured strategic partnerships. This has been an effort that we've been underway since the beginning of the year. It continues to ramp throughout the year, and we certainly saw an impact to net price and really net price compression from the third quarter versus the second quarter, which drove the majority of the sequential decline. Lastly, we did make some intentional trade-offs largely due to product availability. And there were a handful of accounts we chose not to match a lower price from the competition where price at these transactional customers was more important than quality. And so, we expect going forward, which I think is the focus that we are going to remain the PSMA PET imaging agent of choice, the number one in the market that we are incredibly well positioned to grow revenue sequentially in the fourth quarter and to sustain a $1 billion franchise for PYLARIFY going forward.

Operator, Operator

And our next question coming from the line of Anthony Petrone with Mizuho Group.

Anthony Petrone, Analyst

Congratulations on another good quarter here and the positive announcement from CMS. Maybe Paul, just to clear up some of the comments on the final rates for 2025. You said they are largely in line. I know there was some confusion out there between mean unit cost and ASP, but Addendum B seems pretty clear that the reimbursement rate for PYLARIFY will remain steady in 2025. So, just to parse out that in a little bit more detail. And then maybe just quickly, I'll sneak it in. Just the implied 4Q guide a little bit light. So just maybe talk through the bridge between the first nine months and the 2024 guide why the step down sequentially?

Paul Blanchfield, President

So maybe I'll take the CMS question and then I'll let Bob answer the 4Q piece. So as we mentioned in the prepared remarks, and I think as you noted, we're incredibly pleased with the actions that CMS announced on Friday evening, recognizing the value that innovative radiopharmaceutical diagnostics can have on patient care and the importance of ensuring consistent access. CMS did note that they would be paying separately for radiopharm diagnostics above a 630-day arithmetic mean cost, which really just allows for some lower-priced products to remain bundled and then the more innovative products to be separately paid, recognizing that PET radiopharmaceutical diagnostics as well as some specs are not interchangeable and they need to be paid separately. Now what we saw coming out of CMS on Friday is that the final 2025 calendar year payment rate for PYLARIFY very much matches and is effectively the same as its existing payment rate for Medicare fee-for-service patients in the hospital outpatient setting. And so what that really does is sustain PYLARIFY payment in that for 2025. Clearly, there has been some confusion and discussion in the marketplace and the differences between payment rates and what CMS was going to use. I think CMS specifically highlighted seven agents that we note, six PET, one spec that had a material improvement in the payment rate in the final rules versus that of the draft rules in July, and the commonality for the vast majority of those are agents that have recently lost pass-through or are expected to lose pass-through within the next 12 to 15 months. And so those agents are already reporting their true cost to CMS. And therefore, we believe that CMS put in place the payments that they did to support sustained access for those innovative radiopharmaceuticals. And we think this sets us up well for continued growth in the overall market and for PYLARIFY to continue to lead. I'll turn it over to Bob on some of the 4Q guide questions.

Bob Marshall, CFO

From a revenue perspective, you're going to take it by the different pieces. So if you stop and think about PYLARIFY, first and foremost, as Paul has noted multiple times in his prepared remarks, on track for mid-20% for the full year. And we do expect from a net and gross basis PYLARIFY would be both sequentially and year-over-year improved moving from Q3 into Q4. From a pure dollar perspective, we had always thought that Q4 would be greater than Q1. DEFINITY looks to be sort of 10%-ish for the year. But that and the spec business, as Paul noted, there are some competitive dynamics with people having other competitors having supply issues, we don't forecast those kinds of things that necessarily continue because we don't control that part of the business. So from that perspective, I do think that there could be some opportunity for overperformance in both of those. But at the same time, again, we don't forecast for those type elements. As far as EPS goes, yes, absolutely. It is a step down from Q3 into Q4. But that's predicated on the fact that as I had noted even on the prior call, that we would expect R&D expenses to increase from Q3 to Q4, and that is really the biggest step-up in OpEx between the two quarters and hence, the step down in projected earnings.

Operator, Operator

And our next question coming from the line of Richard Newitter with Truist Securities.

Richard Newitter, Analyst

You mentioned that you are confident PYLARIFY will sustain as a $1 billion franchise in 2025, using the term sustain rather than grow. You indicated that you believe the pricing for hospital patient Medicare settings will remain relatively stable. Can you clarify why you chose the word sustain instead of grow? Do you have direct communication with CMS that supports your confidence in maintaining unchanged pricing at the market level in 2025? What is your level of confidence on this, or is it more of an assumption that could potentially change?

Brian Markison, CEO

Thanks for mixing up the questions like that. I'm not sure which one to answer first. But let's start with PYLARIFY. I believe Paul clearly indicated that we expect growth for PYLARIFY next year, specifically in terms of volume growth. Paul, do you want to add anything to that?

Paul Blanchfield, President

Rich, I think we're confident we're going to sustain, as I said, a $1 billion franchise. We're still just wrapping up the third quarter. Based on the roll-in of our strategic partnerships, we have seen net price compression in the third quarter based on securing those long-term partnerships. We would expect those to normalize over the course of 2025 and effectively be reflected in the comparables. And so they will still have an impact as they roll in on an annualized basis. But from a volume perspective, we expect the market to continue to grow. The addressable market currently is $2 billion as we look to additionally approved radio therapeutics, as we look to increasing incidence and prevalence and the continued adoption of PSMA PET over more conventional imaging, we think that market can continue to grow. At this point, we're still just at the end of the third quarter, and it remains a dynamic environment. And so that's what we're comfortable saying today. But we remain very positive on the overall market, recognizing that these strategic partnerships are secured and roll in, and that there is a transitory impact on net price. On the CMS side of things, I think we have engaged with CMS in the past. We will continue to reach out to them. Based on what we've seen as well as potential alternatives, we feel like PYLARIFY is in a very good position for 2025 as are a number of other innovative radiopharmaceutical diagnostics. Naturally, CMS always reserves the right to make adjustments should they need to. But I think in our conversations with relevant stakeholders in the marketplace, we believe that they clearly understand that innovative radiopharmaceutical diagnostics should need to be paid separately. And if we look in the broadest brushes, we're talking about potentially 20% of patients that have declined over time as Medicare Advantage continues to gain share over Medicare fee-for-service. And so even if we were to see some minor changes, we still think we are in a very good position. I would think I would also note that CMS made it very clear that they're open to paying on ASP going forward. That was in both their proposed rule as well as in the final rule. Unfortunately, there are a number of agents that don't or have not reported ASP because it is not required. PYLARIFY, as well as many other agents, have under pass-through. We will continue to report ASP and so we feel there's a very clear path forward for PYLARIFY to retain separate payment and to be paid for those Medicare fee-for-service patients in the hospital outpatient setting at a rate that is not disadvantaged PYLARIFY relative to other PSMA PET agents.

Operator, Operator

Our next question coming from the line of Matt Taylor with Jefferies.

Matt Taylor, Analyst

Just as a follow-up, I wanted to see if we could pin down on the final addendum there, the unit price is 650. Is that the price that you understand you're going to get now? And as far as the strategic contracting goes, obviously, you gave up some price to lock up these partners longer term. Can you talk about your ability to adjust pricing within those contracts if you are going to get this better price in the future?

Brian Markison, CEO

Yes, I'll take the last question. And to be fair, we really don't lock up anything. We're engaged in a partnership with our key customers to help them grow the business while we grow alongside them. And we're not going to comment on the details in those partnerships because that's obviously competitive intelligence that we just don't want to share. With regard to the pricing, Paul.

Paul Blanchfield, President

Matt, you're reading Addendum B correctly on the proposed price. Naturally, we look at the average fixed amounts used per dose to come out to a proposed or final, in this case, final payment rate for 2025. It's not to say that CMS does not reserve the right to make adjustments, but we feel confident that PYLARIFY is going to be paid appropriately in 2025 and that if an issue at all, it's a far smaller issue than we were, say, at the beginning of the year before CMS came out with these rules to recognize the value that innovative radiopharmaceuticals come out with. And as noted, there are a number of agents where the payment rate materially increased from the proposed rules to the final rules. The common thread appears to be recently having lost pass-through or about to be losing pass-through, which is consistent with reporting ASP.

Operator, Operator

Our next question coming from the line of Larry Solow with CJS Securities.

Larry Solow, Analyst

Can you provide more details on how much of the pricing or strategic partnerships were implemented this quarter? Was there a significant amount, or are there many more that have yet to come in? Is this a good basis to estimate the impact based on this quarter's performance? Additionally, I understand your hesitation to provide guidance for next year, but do you still anticipate PYLARIFY to grow over multiple years, both in terms of volume and with less pricing impact affecting revenue growth?

Paul Blanchfield, President

So I appreciate the question there. I think we're incredibly positive if I look at the long-term first about the growth in the PSMA PET imaging market. We've highlighted an addressable market that's currently around $2 billion and could grow to $3 billion by the end of the decade. And those are based, as I mentioned earlier, on incidence prevalence, continued adoption of radio therapeutics, as well as continued adoption of PSMA PET versus conventional imaging. On the specific pricing piece, I think we're very pleased with the progress that we've made as the market leader; these are very positive conversations with key customers. We kicked this off, as we've highlighted in the past, last year. It really gained steam throughout the course of this year. We will see continued impact as we get deeper into the year with Q4 still partnerships being signed and the full annualization of a full quarter's worth. And so I think we're really going to see this normalize throughout the first half of next year with the second half of '25 really being a kind of go-forward net price compression solidified, given that these are full-year multiyear contracts in nature. And so we're really in the phase-in period where the biggest driver of sequential performance was really the rollout of these. And so we feel very positive that this is a transitory impact. And then overall, the market will continue to grow. PYLARIFY will continue to lead, and this is a very sustainable franchise going forward.

Operator, Operator

And our next question coming from the line of Tara Bancroft with TD Cowen.

Tara Bancroft, Analyst

So I'm going to deviate a little bit from the pricing questions. But I'm curious to hear more on the Alzheimer's diagnostic pipeline. So can you tell us how these assets differentiate from what's currently available or the blood tests that are coming down the external or the other pipeline? What's your thinking on that and on the market for these? And could we potentially hear a little bit more about these in 2025?

Brian Markison, CEO

And thank you for taking us off the pricing track. That's a relief, I guess, because I don't know how many times we can say the same thing. So with our Alzheimer's portfolio, we're really excited about these assets with MK-6240 and NAV because they appear to be best-in-class assets where they have really great detection rates and minimal off-target effects. And I think they're in a very advanced Phase III development right now. So Jeff, do you want to comment a little bit more?

Jeff Humphrey, Chief Medical Officer

Yes. Thank you. These compounds are exciting. They represent the second generation, featuring high sensitivity and low off-target binding. Regarding the question about serologic markers for tau compared to MK-6240 imaging, the main advantage of PET imaging is that it allows visualization of the anatomy, which is linked to factors like symptom severity and the rate of decline, providing valuable information. Additionally, the Alzheimer's Association has endorsed imaging for tau and beta-amyloid for diagnosing, staging, and sometimes monitoring treatment for Alzheimer's disease. We are quite enthusiastic about this portfolio.

Paul Blanchfield, President

Thanks, Jeff. Maybe just a few more points to add, Tara, because I think it's an area that we're incredibly excited about in the portfolio. Naturally not only for the potential if you look at what analysts are forecasting for the uptake of disease-modifying therapies, they're looking at potentially north of 500,000 individuals on therapy by the end of the decade, and that's just based on recently approved agents. If you look at their labels and note that they are requiring the presence, in this case, of beta-amyloid pathology, that creates a very large potential market for Alzheimer's PET imaging. We've looked at it to be about $1.5 billion by the end of the decade and $2.5 billion by the middle of the 2030s. And so that's a significant opportunity. Serological blood testing very much is going to have a role in this marketplace. I think we look at it as very complementary to imaging, much as we've seen in prostate cancer, where PSA screening becomes commonplace when a man reaches the age of 45 or 50, but that really helps determine along with many other factors, which patients are appropriate for PSMA PET scan, and we believe eventually will be appropriate for an Alzheimer's PET scan, which can only grow the market from a complementary basis. And I would note it's somewhat obvious, but these are both F-18 agents that would leverage the same commercial and production infrastructure that we've established with PYLARIFY. And so we really like the position and the opportunity to continue to grow with the overall therapeutic market for the support of both diagnosis, staging, and monitoring, which create significant scan potential per individual patients.

Operator, Operator

And our next question coming from the line of Yuan Zhi with B. Riley.

Yuan Zhi, Analyst

Maybe asking the question differently. So for the CMS reimbursement rate update, result the MUC method will get a lower reimbursement rate for the RFI. However, in this latest update, it actually went up. So how should we think about this calculation? What does it mean to 2026 if there is a change from this MUC to ASP methods?

Paul Blanchfield, President

I know there's a lot of considerations in the marketplace, so understand there's some confusion in the differences with what CMS has come out with. I think what we've seen, and I don't mean to just reiterate but what I think we've seen, is CMS came out with their calendar year 2025 goals, which is different. Just to note, for some other CMS payment mechanisms whereby they adjust quarterly. This is a calendar year final rate. Naturally, they reserve the right to make adjustments, but there is commonality amongst some of the material adjustments they've made. We continue to report ASP for PYLARIFY. We have been doing so since launch. We will continue to do so going forward. And so while it's a little early to determine exactly what payment rates would be for 2026, based on the rate we have as well as CMS' openness to paying on ASP once that becomes more ubiquitous in the radiopharmaceutical diagnostic space, we believe that that could be sustainable. We will continue to report ASP. If CMS adjusts, as they've said they would be open to their payment mechanisms to be more based on ASP versus MUC, PYLARIFY would be set up to, again, have their payment rates reflect the true current cost to hospitals. Naturally, we will be working as part of the broader coalition to ensure that all innovative radiopharmaceutical diagnostics continue to report ASP to further support CMS's intent to move there. That's just not possible at this time given not everyone reports ASP.

Operator, Operator

Our next question coming from the line of Kemp Dolliver with Brookline Capital Markets.

Kemp Dolliver, Analyst

I'm going to ask about PNT2002 and this is going to be a hypothetical question. But if CMS wants you to go to wait for 100% of events in the trial. Are we looking at roughly a six-month time frame, nine-month time frame? What should we expect if you have to go that route?

Brian Markison, CEO

I think you're referring to the FDA. And it's possible that the agency would like to see the completion of the study. If you look at the rate of reported OS events from us and our partner, it's not unreasonable to think that this will continue into the first quarter. However, clearly, we don't control the final OS event, which could keep the trial open for a bit longer. So I really prefer not to speculate too much on that. And I think, look, we're going to confirm with our partner, Lilly, as I mentioned and also reach out to the agency to get a better understanding of a clear path forward.

Operator, Operator

And the next question coming from the line of Justin Walsh with Jones Trading.

Justin Walsh, Analyst

Sticking with PNT2002, I'm wondering if you can provide any commentary on the planned subset analyses. And related to this, what outcomes do you think would push Lantheus to stick with the point Lilly agreement versus stepping away?

Brian Markison, CEO

We have a lot to discuss. We mentioned that we are conducting subset analyses. If you refer to the recent ESMO meeting and Dr. Sartor's presentation, he highlighted some post hoc analyses where we adjusted for the overall survival crossover rate, and the findings were quite positive, supporting the effect of PNT2002 in this population. We still have work to do to analyze the data, and Jeff can provide more insight on this if he wishes. We will keep working with Lilly and will consult with the agency to determine our next steps. It’s worth noting that we have demonstrated that this is a safe and effective product. However, the significant crossover from the hormonal therapy switch arm to PNT2002 has complicated the overall survival events and the statistics for the intent-to-treat population. This poses a challenge that many of us involved in designing and conducting similar trials are facing. Jeff, would you like to add anything?

Jeff Humphrey, Chief Medical Officer

Yes, I would just add that it's very clear this trial met its primary endpoint. It has benefits on the quality of life endpoints. And Oliver Sartor was very positive about the study when she presented as well. I think the field has been positive as well.

Operator, Operator

And our next question coming from the line of Andy Hsieh with William Blair.

Andy Hsieh, Analyst

We are curious about the $1.5 billion, $2.5 billion total addressable market for the Alzheimer's market yet things we're providing that guidance. Maybe talk about kind of the number of scans dynamic that's baked into this assumption. And what's currently kind of the average scans per patient? And how will that grow in your view into the next decade? And along with that, how will the dialogue with payers just to ensure then that there is actually a benefit to patients as you kind of use these agents to track the disease progression on a longitudinal basis?

Paul Blanchfield, President

Thank you for your questions, Andy. They are very relevant. When examining our assumptions concerning the addressable market, these are largely based on the general consensus regarding the uptake of therapies. I might have mentioned this before. We anticipate that, based on currently approved disease-modifying treatments for Alzheimer's, we could see around 500,000 patients undergoing therapy by the end of the decade. We are still in the early stages of understanding how many scans per patient will occur for diagnosis, staging, and monitoring. However, if we do some quick calculations, the list price for neurological scans, specifically for tau and beta-amyloid, is about $3,000 each. With a potential 500,000 patients and the cost per scan, this amounts to approximately $1.5 billion. Of course, some patients will require multiple scans, and not every patient scanned will go on therapy, so there will be some selection involved. At this early stage of market growth and therapeutic adoption, it's difficult to specify exact figures. Nonetheless, the benefits of a scan can be significant. First, it supports the label for recently approved therapeutic agents. Secondly, looking at the payer dynamics, a $3,000 scan as a one-time event plus the procedure cost compared to therapies priced between $30,000 and $35,000 becomes vital. With 6 million Americans suffering from Alzheimer's disease or advanced dementia, it’s crucial to ensure that eligible patients receive therapy timely and that we monitor their progression as a healthcare system. A PET scan serves as an excellent insurance policy for payers looking to manage potentially tens of billions in therapeutic expenses. It ensures that the right patients begin treatment promptly. Similarly to the adoption of PSMA PET, which has significantly improved patient care, we see that while the diagnostic market is substantial and we are excited to participate, the therapeutic market is even more significant and costly from a payer's standpoint. Consequently, we believe these agents will offer considerable value, helping to inform patient care and potentially save money for the healthcare system.

Operator, Operator

And our next question coming from the line of Ed Ridley-Day with Redburn Atlantic.

Ed Ridley-Day, Analyst

If we could follow up a little bit also on if you can give any color on how we should be thinking about the royalties from PYLARIFY now that, that is launched in any early color that you have on that, that would be helpful. And also, you highlighted obviously the approval of Flycardo. How would you be thinking about the ability to grow that business given also the supply implications?

Paul Blanchfield, President

We appreciate the inquiries about our partnerships. We are very pleased with the approvals of Poclari in Europe and various markets. In Europe, the ramp-up is naturally slower compared to the U.S. due to local regulatory approvals and pricing factors. Curium is actively working to commercialize that market. As we mentioned previously, we are very excited about the potential of PYLARIFY and Poclari to become a global brand and to be highlighted at medical conferences worldwide. From a financial standpoint, the immediate impact on our results is minimal as they continue to ramp up. While we are optimistic about future growth, it is not expected to be a significant driver of PYLARIFY's performance at this time. Regarding the Flycardo product, GE holds the commercialization rights, and we collaborate with them on a joint steering committee. The market opportunity is substantial given the number of MPI studies. For specific inquiries, I would recommend reaching out to GE, as they lead the commercialization of that agent. Cardiac imaging presents a large market in spec and is significant in PET with Rubidium. GE will provide insights into the benefits of that agent. Overall, we are excited about the introduction of another innovative PET imaging agent to the marketplace, and we will continue to earn relevant milestones and receive royalties in the U.S. as well as on sales outside the U.S.

Operator, Operator

And ladies and gentlemen, there are no further questions in the queue at this time. Thank you for your participation in today's conference. This concludes the program. You may now disconnect and have a wonderful day.