NASDAQ:LNTH Lantheus Q3 2025 Earnings Report $93.91 0.00 (0.00%) Closing price 05/15/2026 04:00 PM EasternExtended Trading$94.10 +0.20 (+0.21%) As of 04:56 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast Lantheus EPS ResultsActual EPS$1.27Consensus EPS $1.27Beat/MissMet ExpectationsOne Year Ago EPS$1.70Lantheus Revenue ResultsActual Revenue$384.01 millionExpected Revenue$363.42 millionBeat/MissBeat by +$20.60 millionYoY Revenue Growth+1.40%Lantheus Announcement DetailsQuarterQ3 2025Date11/6/2025TimeBefore Market OpensConference Call DateThursday, November 6, 2025Conference Call Time8:00AM ETUpcoming EarningsLantheus' Q2 2026 earnings is estimated for Wednesday, August 5, 2026, based on past reporting schedules, with a conference call scheduled at 8:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Lantheus Q3 2025 Earnings Call TranscriptProvided by QuartrNovember 6, 2025 ShareLink copied to clipboard.Key Takeaways Neutral Sentiment: Lantheus announced a planned leadership transition with CEO Brian Markison retiring at year-end, Board Chair and former CEO Mary Anne Heino named interim CEO while a comprehensive search for a permanent successor is launched, and President Paul Blanchfield departing for a new opportunity. Positive Sentiment: The company reports Polarify volumes up 3.3% y/y and says pricing has begun to stabilize, and it is preparing a new F18 PSMA formulation (≈50% larger batch size) targeted for launch after coding/three years transitional pass-through in 2026 to enhance production efficiency and patient access. Negative Sentiment: Q3 results show consolidated revenue of $384M (+1.4%) but margin pressure — gross margin down 471 bps and adjusted EPS fell ~25% (adjusted EPS $1.27 for Q3); management narrowed FY revenue to $1.49–$1.51B and adjusted EPS to $5.50–$5.65, signaling near-term profitability headwinds. Positive Sentiment: Strategic diversification is progressing — NeuroSeq is expanding (20 PMFs with six more planned in 2026) and MK-6240 (tau PET) has an FDA PDUFA date of August 13, 2026, while recent acquisitions (Life Molecular Imaging, Evergreen, Melior) and programs like LNTH-2501 aim to broaden radiodiagnostic and theranostic offerings. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallLantheus Q3 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Morning. Welcome to Lantheus Third 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. Mark KinarneyVP of Investor Relations at Lantheus Holdings Inc.00:00:28Thank you. Good morning. With me today are Brian Markison, our CEO, and Bob Marshall, our CFO. We will begin with prepared remarks and then take your questions. This morning, we issued a press release, which was furnished to the SEC under Form 8-K, reporting our third quarter 2025 results. The release and today's slide presentation are available in the investor section of our website. Any comments could include forward-looking statements. Actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings. Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the investor section of our website. I will now turn the call over to our CEO, Brian. Brian MarkisonCEO at Lantheus00:01:18Thank you, Mark, and good morning, everyone. In addition to the earnings press release issued this morning, we announced a leadership transition plan to guide Lantheus into its next chapter of long-term growth. As a part of this plan, I will retire from Lantheus at the end of this year and transition into an advisory role. Mary Anne Heino, our current Board Chairperson and prior CEO, will assume the role of Executive Chairperson now and serve as interim CEO following my retirement. This structure allows Mary Anne and me to work closely together with our leadership team to ensure a smooth transition over the coming months. Mary Anne led Lantheus as CEO for nine years, driving significant growth throughout her tenure before becoming Chairperson in early 2024. Brian MarkisonCEO at Lantheus00:02:08With her extensive industry experience and deep knowledge of Lantheus, Mary Anne is well positioned to continue executing our strategy and driving momentum while we prepare for the expected launch of our new F 18 PSMA PET formulation. The board has initiated a comprehensive CEO search led by our lead independent director to identify and appoint our next CEO, who will build on our strong foundation. We also announced that our President, Paul Blanchfield, will be leaving Lantheus for a new opportunity. We thank Paul for his many contributions and wish him continued success in his new role. I would also like to note that Amanda Morgan will return from leave and continue in her role as Chief Commercial Officer, reporting directly to Mary Anne. Brian MarkisonCEO at Lantheus00:02:59Before Bob and I review the business performance, I want to express what an honor it has been to serve on the board and lead such a talented and purpose-driven group of employees at Lantheus. I am proud of our collective achievements and the remarkable progress we've made to strengthen Lantheus's position as the leading radiopharmaceutical-focused company. We executed a series of strategic transactions, including the acquisitions of Life Molecular Imaging, Evergreen Theragnostics, and Meilleur Technologies, along with key licensing agreements. These transactions diversified our revenue streams, expanded our capabilities across the radiopharmaceutical value chain, and positioned us for successful regulatory submissions. Most importantly, they enabled us to build a robust and innovative pipeline of radiodiagnostics, including advancing our position in the growing Alzheimer's disease imaging market and our early-stage radiotherapeutic products. Now turning to the Lantheus results. Brian MarkisonCEO at Lantheus00:04:07In the third quarter, our top priority was and remains executing our commercial strategy to maximize the long-term value of our prostate cancer franchise. Our PYLARIFY results for this quarter reflect our ongoing efforts to maintain a disciplined approach to pricing and to raise awareness of PYLARIFY's clinical differentiation. The pricing stabilization across our accounts that began early in the third quarter has continued, and actions we implemented in the second and third quarters to maintain our market leadership will continue to play out over time. Looking ahead, we are preparing for the potential approval of our new F18 formulation in 2026. We anticipate this will qualify for three years of transitional pass-through payment status, supporting our PSMA PET franchise growth beginning in late 2026 and into 2027. Now turning to PYLARIFY. Sales were $240.6 million during the quarter, down approximately 7% year-over-year, with U.S. Brian MarkisonCEO at Lantheus00:05:15Volumes up 3.3% and down slightly sequentially due to seasonality, both consistent with our expectations. Further to that point, large institutions continued to diversify their PSMA agents across PYLARIFY and Gallium-68 agents, while smaller accounts grew in line with market rates. Importantly, our educational efforts and customer feedback reflect increasing recognition of PYLARIFY's clinical value, and anecdotally, we are seeing some sites return after trialing alternatives. As I mentioned earlier, signs of pricing stabilization persisted throughout the third quarter and into October. We are preparing for the expected launch of our new F18 PSMA PET formulation, which optimizes the manufacturing process to potentially increase batch size by approximately 50%, which could enhance production efficiency, supply resilience, and enable increased patient access. We plan to introduce this new agent to the market following the receipt of coding, coverage, and reimbursement, including a HCPCS code and transitional pass-through payment status. Brian MarkisonCEO at Lantheus00:06:30We expect this plan to level the reimbursement playing field. For the remainder of 2025, we expect low single-digit volume growth offset by further price compression as 340B, or best price, resets in the fourth quarter as a result of the two-quarter lag in government price reporting, reflecting price concessions offered in the second quarter. Importantly, we do not anticipate any material changes to 340B from the fourth quarter into the first quarter of 2026. As PYLARIFY's in-market best price remained consistent from the second quarter to the third quarter of this year. These resets are factored into our guidance, and we are actively mitigating the impact through targeted commercial strategies. Our focus remains on preserving the long-term value of our PSMA PET franchise. DEFINITY continues to deliver consistent performance, growing more than 6% year-over-year despite experiencing slight unfavorable customer mix in the quarter. Brian MarkisonCEO at Lantheus00:07:40We remain confident in DEFINITY's market leadership and the continued growth of the ultrasound-enhancing agent market. DEFINITY's success continues to be anchored in its proven clinical and commercial value with a 24-year track record of clinical application and continued customer satisfaction. Turning now to our neurology franchise, we see significant growth potential in the U.S. Alzheimer's disease radiodiagnostic market, driven by rising prevalence, expanded PET imaging guidelines, and increasing use of amyloid beta and tau PET imaging agents alongside disease-modifying therapies. Today, there are two approved therapies and more than 100 in development, including approximately 30 tau-directed therapies and 40 beta-directed amyloid therapies, underscoring the critical role PET imaging can play in diagnosis and treatment selection. In the third quarter, Neuraceq delivered sales consistent with expectations. Brian MarkisonCEO at Lantheus00:08:47Neuraceq is our F18 PET imaging agent used to detect beta-amyloid plaques in patients being evaluated for Alzheimer's disease and select patients for amyloid beta-directed therapy, and is already enhancing the depth of our relationships with nuclear medicine customers and our manufacturing partners. Our strategy for Neuraceq focuses on three main priorities. First, expanding geographic coverage to ensure broad access across leading Alzheimer's centers and community practices, including with the recent addition of two new PMFs in Southern California and Illinois. Neuraceq has growing geographic coverage in the U.S. across 20 PMFs, and we plan to launch six additional PMFs in 2026. Second, improving availability and scheduling flexibility. Third, leveraging revised appropriate use criteria, or AUC, and updated benefit manager guidelines, which recommend repeat scanning. Brian MarkisonCEO at Lantheus00:09:50We are advancing MK-6240, our F18 PET imaging agent, for detecting tau in adults being evaluated for Alzheimer's disease, and the FDA has set a PDUFA date of August 13, 2026. Our NDA submission was supported by data from two pivotal phase three clinical trials, which evaluated MK-6240's performance in detecting tau pathology in early Alzheimer's disease. These studies met their co-primary endpoints of sensitivity and specificity to detect tau tangles. MK-6240 previously received fast-track designation, reinforcing its potential to address a significant unmet need in Alzheimer's disease diagnostics. We believe PET imaging is foundational to the diagnosis and management of Alzheimer's disease. The recent FDA approval of blood-based biomarkers is an important advancement, enabling earlier identification of patients. We believe these tests will expand the readily addressable market over time and complement, not replace, the critical value PET imaging provides in visualizing and quantifying disease. Brian MarkisonCEO at Lantheus00:11:06In addition to our work progressing our new F18 PSMA PET formulation and for MK-6240, we also are planning for potential approval of LNTH-2501, which is also known as Octavi, which is a PET diagnostic imaging kit targeting somatostatin receptor-positive neuroendocrine tumors, or as we commonly refer to them, NETs. If approved, LNTH-2501 may complement Lantheus's therapeutic candidate, PNT2003, as part of a theragnostic pair advancing the company's strategy to deliver integrated diagnostic and therapeutic solutions for patients with cancer. These four products strategically diversify our business and further solidify Lantheus's position as the nuclear medicine partner of choice. As we execute our strategy and advance our leadership in radiopharmaceuticals, we remain focused on delivering strong financial performance and disciplined capital allocation. To provide more detail on our third-quarter results and outlook, I'll now turn the call over to Bob. Bob MarshallCFO at Lantheus00:12:17Thank you, Brian, and good morning, everyone. Bob MarshallCFO at Lantheus00:12:21I'll provide details of the third-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 third quarter was $384 million, an increase of 1.4%. Radiopharmaceutical Oncology, currently PYLARIFY, contributed $240.6 million of sales, down 7.4%. U.S. volumes were up 3.3% year-over-year and down slightly sequentially due to seasonality, as expected. Precision diagnostic revenue of $129.7 million was up 25%. Highlights include sales of DEFINITY at $81.8 million, 6.3% higher, along with TechneLite revenue of $21.1 million, up 3.2%. Additionally, Neuraceq contributed $20.4 million in the abbreviated quarter. Lastly, strategic partnerships and other revenue was $13.7 million, down 10.1%. Driven mainly by our investigational product candidate, MK-6240, at $6 million of revenue, down 39.9%, due mainly to the timing of milestones received in the prior year quarter not repeated. Bob MarshallCFO at Lantheus00:13:33Gross profit margin for the third quarter was 63.5%, a decrease of 471 basis points. The decrease is mainly attributed to unfavorable pricing impacts to margin, the inclusion of Evergreen and LMI margin profiles, and E&O charges, which accounted for approximately 50 basis points of gross margin headwind in the quarter. Operating expenses at 32.4% of net revenue were 775 basis points higher than the prior year rate, but generally in line with previously guided underlying spending levels with the inclusion of both Evergreen and LMI, as well as additional investments in our R&D pipeline. Operating income for the quarter was $one one9.6 million, or a decrease of 27.6%. Other income and expense were $2.4 million of expense. This is slightly lower than expected due to a decreased cash position from the $100 million of shares repurchased during the quarter that resulted in lower net interest income to offset interest expense. Bob MarshallCFO at Lantheus00:14:34Total adjustments in the quarter were $74.8 million of expense before taxes. Of this amount, $24.5 million and $14.6 million of expense is associated with non-cash stock and incentive plans and acquired intangible amortization, respectively. Non-recurring expenses tied to closing and integrating our announced acquisitions and divestiture totaled $34.8 million. Our effective tax rate was 26.9%. The resulting net income for the third quarter was $27.8 million and $85.7 million on an adjusted basis, a decrease of 30.9%. GAAP fully diluted earnings per share for the third quarter were $0.41 and $1.27 on an adjusted basis, a decrease of 25.3%. Now turning to cash flow, third-quarter operating cash flow totaled $105.3 million, down $69.8 million from the prior year. The variance is driven in part by M&A fees and integration cash costs incurred in the quarter of $35.1 million. Capital expenditures totaled $10.6 million, down $5.2 million. Bob MarshallCFO at Lantheus00:15:43Free cash flow, which we define as operating cash flow less capital expenditures, was $94.7 million, $64.6 million lower than the prior year period. During the quarter, the company invested $100 million in its own shares at an average price of $56.94 for 1.756 million shares. Also, the company completed the acquisition of Life Molecular Imaging with an outlay of approximately $309 million net of cash acquired. Taken together, cash and cash equivalents, net of restricted cash, now stand at $382 million. We have access to our $750 million undrawn bank revolver and are comfortable with our strong liquidity position. Turning now to our updated guidance for the full year of 2025, we are narrowing our view of full year revenue to the higher end of the range to reflect recent trends we saw throughout Q3 as well as quarter to date. Bob MarshallCFO at Lantheus00:16:39Principally, we estimate that PYLARIFY will come in toward the higher end of the prior range of $940 million-$965 million. Neuraceq's contribution should also trend to the higher end of the prior range. Taken together, full year revenue is now expected to be in a range of $1.49 billion-$1.51 billion from the prior range of $1.475-$1.51 billion. We are also narrowing our estimates of adjusted EPS to a range of $5.50-$5.65 versus the prior guide of $5.50-$5.70. With that, let me turn the call back over to Brian. Brian MarkisonCEO at Lantheus00:17:17Thank you, Bob. As I mentioned earlier, I look forward to collaborating with Mary Anne and the board over the coming months and supporting Lantheus in an advisory role after retiring. In the meantime, I remain committed to advancing and executing our strategy. Brian MarkisonCEO at Lantheus00:17:35This includes continuing to build on Lantheus's strong leadership position in radiopharmaceuticals. We're staying laser-focused on driving PYLARIFY commercial execution as we prepare for the next chapter of our prostate cancer franchise. We're also advancing our strategic diversification plan, including the ongoing integration of our recent acquisitions and preparing for four near-term product approvals that we expect to fuel our next wave of growth. The talented teams from Life Molecular Imaging and Evergreen significantly strengthen Lantheus's ability to execute operationally and commercially and ultimately allow us to expand our patient impact. We're advancing our innovative investigational assets across oncology, neurology, and cardiology and expanding our commercial portfolio that enables clinicians to fight, follow disease to deliver better patient outcomes. It's been a privilege to lead Lantheus as CEO. Brian MarkisonCEO at Lantheus00:18:36Together, we have built a robust radiodiagnostic and radiotherapeutic pipeline, positioned Lantheus for successful regulatory submissions, and strengthened our capabilities and expertise in the growing Alzheimer's disease radiodiagnostic market and across the radiopharmaceutical value chain. I'm confident that Lantheus is well-positioned to drive long-term growth and enhance value for all our stakeholders. With that, operator, I'll now turn it over to questions and answers. Thank you. Operator00:19:09As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One question per person, please. Please stand by while we compile the Q&A roster. Our first question comes from the line of Roanna Reese from Leerink Partners. Roanna ReeseAnalyst at Leerink Partners00:19:38Great. Good morning, everyone. I want to extend my best wishes to you, Brian, on your next endeavor. A quick question for me. Roanna ReeseAnalyst at Leerink Partners00:19:48I noticed on you were talking about the PYLARIFY and Neuraceq likely being in the higher end of range of guidance based on trends in the quarter and to date. I was curious if you could elaborate on those, what strategies are getting traction here, and how could those continue into 2026. Thanks, Brian MarkisonCEO at Lantheus00:20:10Roanna. I'll take the beginning of it and then flip it to Bob. By the way, welcome back and congratulations to you. I think what you're seeing with PYLARIFY is, as we've reflected in the prepared remarks, a stabilization in the PSMA market. We have, I would think, weathered the storm appropriately with execution as we changed from an ASP reimbursement environment to one of MUC. We're seeing customers that are trialing different agents actually come back to PYLARIFY, and that's quite rewarding. With Neuraceq, it's really all about expansion and availability. Brian MarkisonCEO at Lantheus00:20:53It's a great amyloid tracer. Under the Life Molecular Imaging umbrella, it has not had the resources to expand in a way that we have with PYLARIFY. It is all about, for us, availability, expansion, being there for our customers, and also driving our portfolio. Bob, do you care to comment? Bob MarshallCFO at Lantheus00:21:12Yeah. I mean, to kind of tack on to that, the visibility that we have as we look to the balance of this year, obviously, our focus is on executing the strategy that we've had in place, which we will continue to do. It is still a competitive market, and we will continue to monitor that extremely closely, particularly as we go into the new year. Bob MarshallCFO at Lantheus00:21:33I'm not going to comment on 2026 as we're not in a place to provide guidance, but when we do, it'll take into consideration all the different market and environmental dynamics that we see at that time. Operator00:21:44Thank you. One moment for our next question. Our next question comes from the line of Richard Newitter from Truist. Richard NewitterManaging Director at Truist Securities00:21:55Hi. Thanks for taking the questions. I wanted to just ask, actually, a couple. I know you're not giving 2026 guidance, but is there, I think investors are definitely focused on the possibility of any major resets coming. So anything you can highlight relative to where you see consensus? I think consensus earnings is around $575 for next year, and PYLARIFY is hovering a little over $900 million. Sounds like with the step up in visibility today around PYLARIFY, that might not be a bad place to be. Richard NewitterManaging Director at Truist Securities00:22:38Anything you can comment on 2026, even if it's just directional relative to consensus, it would be helpful. Thank you. Brian MarkisonCEO at Lantheus00:22:44Yeah, Rich, I appreciate the question. We're not going to comment on 2026 guidance. I think what we can tell you and what we're seeing in the market right now is the stabilization of our account base. We're also seeing continued year-over-year and sequential volume growth for PYLARIFY. We're seeing a lot of promising signs as we focus on growing the market, preserving the growth, and preparing for our launch of our new formulation. Operator00:23:20Thank you. One moment for our next question. Our next question comes from the line of Matt Taylor from Jefferies. Matt TaylorManaging Director at Jefferies00:23:28Hi. Good morning. Thanks for taking the question. I was hoping just because there's a lot of significant management changes, you could talk a little bit more about. Matt TaylorManaging Director at Jefferies00:23:40Why now in terms of retiring, why Paul's leaving, and I guess what you're looking for in a new CEO and how long that process could take. Brian MarkisonCEO at Lantheus00:23:48Yeah, thank you. I appreciate the question. First, let's uncouple the two management changes with Paul and Brian. Paul is going to a great opportunity. It's wonderful. We're excited for him. It's also gratifying to Lantheus that we continue to churn out some great executives into the marketplace. As for me, my decision's personal. I've got nine grandchildren, and actually, I think number nine was the tipping point for me. When I came into the role, it was not with any expectation that this would be a long-term assignment, and that I came in to rebuild a pipeline, rebuild an R&D organization, and position this company for sustained long-term growth. I feel really, really good about doing that. Brian MarkisonCEO at Lantheus00:24:37It is time for me to step aside. The other thing that is really good here that we should take note of is that Mary Anne is very close to this business. She was the CEO for nine years. She has been part of it as a board chair for the past two years, and we have worked very closely together for the past 13 years. This is a seamless transition with an expert who is coming back in on an interim basis as we have also announced a CEO search. Our lead independent director is heading up that search. It will be comprehensive. Obviously, we are looking for outstanding individuals that can take this company to the future. How long the process will take, I cannot determine that. Right now, it is very early in stages. Brian MarkisonCEO at Lantheus00:25:25You can look at industry averages from announcements like this to time of new placement, and you can figure it out for yourself. This is a very attractive role for an up-and-coming, rising CEO candidate. I have no question that we are going to find an outstanding person to come in here and build for the future. Thank you. One moment for our next question. Operator00:25:48Our next question comes from the line of Paul Choy from Goldman Sachs. Paul Choy from Goldman Sachs, your line is now open. Please proceed. One moment for our next question. Our next question comes from the line of Yuan Zhu from B Riley. Operator00:26:16Thank you for taking our questions. What was the advantage of F18-labeled PYLARIFY? They are produced in 20 or 40 doses per batch. Operator00:26:28Since competitor GOZELLIX came to the market, do you notice that they are producing in cyclotrons with a similar number of doses per batch and taking market shares away from your high-volume customers? Thank you. Thanks, Juan. I appreciate the question. We're not seeing a lot of impact from GOZELLIX produced on a cyclotron. We're seeing, actually, as I mentioned in the prepared remarks, very good and consistent growth with our smaller accounts that have more capacity and that are growing with the market. We are seeing in our much larger accounts those sharing, if you will, with Gallium-68. Those are the accounts that have a tremendous amount of volume. We are not seeing any real impact that I can measure right now from GOZELLIX on a cyclotron. I'm not at the moment concerned about that. Operator00:27:21Thank you. One moment for our next question. Operator00:27:28Our next question comes from the line of Larry Solo from CJS Securities. Pete LucasAnalyst at CJS Securities00:27:34Hi. Good morning. It's Pete Lucas for Larry. Just one question. If you could give us a little more color on the competitive landscape in the Alzheimer's imaging market, particularly on the tau tangle side of the market, and how MK-6240 is positioned against other products. Brian MarkisonCEO at Lantheus00:27:51Yeah. Thanks, Pete. Great question. So again, MK-6240 has been filed with an expected PDUFA date of August 13, 2026. I think we look at MK-6240 as a second-generation tau agent. Talvet is the only agent commercially available today. There is a lot of interesting information out of different clinical trials, one notably the head study out of the University of Pittsburgh, where they directly compare these tracers, all the tau agents, whether they're investigational or the one commercially available, head-to-head, if you will. Brian MarkisonCEO at Lantheus00:28:34The superiority of MK-6240 is in evidence and reported in these studies, and we have discussed it in previous earnings calls. I think the major thing to look for here as the marketplace evolves and guidelines evolve. Clearly, the role of tau is going to become increasingly more important as you look at staging, longitudinal management, and tracking. What tau gives you the ability to do is look at where in the brain the tangles are, if you will, and what parts of the brain are they affecting, and how does the patient with AD really behave, whether it is memory, whether it is balance, whether it is speech. All of these things come into play when looking at tau and assessing its disposition in the brain of an Alzheimer's disease patient. We feel that MK has a significant competitive advantage. Brian MarkisonCEO at Lantheus00:29:33However, I would like to point out that the market is relatively immature for tau, and the beta-amyloid market is really exploding right now in front of us. Operator00:29:42Thank you. One moment for our next question. Our next question comes from the line of Tara Bancroft from TD Cowen. Tara BancroftDirector, Senior Analyst, and Biotech Equity Research at TD Cowen00:29:53Hi. Good morning. I am wondering if you could tell us more about the various factors and maybe feedback that you are hearing from your partners that are leading the market to reach this pricing stabilization exactly. Then, along that line, do you believe that this will remain kind of a three-player market in the near term, like into 2026, given the various pass-through dynamics that are expected next year for you and for others? Thanks so much. Brian MarkisonCEO at Lantheus00:30:22Yeah. In the near term, I expect it to be a three-player market. I think. Brian MarkisonCEO at Lantheus00:30:30In a competitive market like ours, and given the success we've had. Simply looking at the revenues we reported for PYLARIFY, you naturally do attract competition. We think the stabilization we're seeing, and our description of our strategy to be disciplined on price, has played through in the marketplace with our accounts and our customers. The other thing to note is our service is top-notch. Our ability to deliver doses on time in full is unparalleled. I think that service quotient and our team in the field, along with our PMF partners, needs to be recognized as part of our success. It is not simply introducing another agent. It is also having the feet on the street and the knowledge that we have to really execute. The other part of this, though, is the clinical differentiation of PYLARIFY is really beginning to shine, if you'll excuse the pun. Brian MarkisonCEO at Lantheus00:31:30I think in patients with low-volume disease where they're suspected of a recurrence or even on initial staging and diagnosis, PYLARIFY has a very clean and distinct signal, and its sensitivity and specificity are really unparalleled. You could just look at the other competitors' package inserts to compare them. In all, I believe this market stabilization we're seeing now is healthy. I think that customers are making the right decision for their patients, and I think our team in the field is really rocking it. I expect continued growth out of this franchise. Operator00:32:12Thank you. One moment for our next question. Our next question comes from the line of Justin Walsh from JonesTrading. Justin WalshEquity Research Analyst at JonesTrading00:32:21Hi. Thanks for taking the question. What are your thoughts on the potential dynamics that could emerge in the PSMA imaging market as other clinically differentiated products enter? Justin WalshEquity Research Analyst at JonesTrading00:32:31I know one potential competitor has a copper-64-based agent in late-stage development, and it would be great to hear how Lantheus will maintain your edge in the space. Yeah. I think the copper-64 agent is certainly of interest to us, and we are monitoring their progression carefully. I think when you look at real differences in the clinic, that will have to play out. But we're highly confident that our sensitivity and specificity at our network will continue to be the major force in the marketplace. We're watching it very carefully, and I really don't have too many concerns at the moment about that. Bob MarshallCFO at Lantheus00:33:16Justin, I'll just tack on. I just think that you're also talking about it launching into what we believe will be a continuing market opportunity. A rising tide lifts all boats. Bob MarshallCFO at Lantheus00:33:28Certainly, if there's a carve-out share for them, it would be into a market that is going to approach $3.5 billion plus by the end of the decade. A lot of that predicated on the growing use from an RLT perspective. Justin WalshEquity Research Analyst at JonesTrading00:33:46Right. Let's leave it at that. Operator00:33:51Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our next question comes from the line of Kemp Doliver from Brookline Capital Markets. Kemp DolliverDirector of Research and Senior Analyst at Brookline Capital Markets00:34:14All right. Thank you. And good morning. Brian, what are you thinking regarding the pending Medicare hospital outpatient rule, which A is overdue, and then also the possibility that they will transition to ASP from MUC? Thanks. Yeah. Brian MarkisonCEO at Lantheus00:34:39I think when you look at the end of last year, there was a moment in time where we had ASP, then we did not, then we had it again, and then we did not. Now we are in the MUC environment. I think the Hill is a bit in disarray at the moment. However, we continue to lobby, we continue to work with CMS, and we are continuing to educate them. I think the belief out there, and certainly we share this, is that moving to ASP eventually is the right move for all parties involved. It simplifies everything from both our end and from CMS. However, I think at the moment, with a bit of a disarray, it is hard to break through and have your voice heard. I think for 2026, I am not anticipating much change, but certainly for 2027. Brian MarkisonCEO at Lantheus00:35:29We are predicting that there could be meaningful change to ASP. Operator00:35:32Thank you. One moment for our next question. Our next question comes from the line of Yuan Zhu from B. Reilly. Operator00:35:44Follow-up from us. Now your acquisition is complete. Can you provide additional color on the growth trajectory from the past and looking forward, as well as your plan to gain market share there? Thank you. Brian MarkisonCEO at Lantheus00:36:00Yeah. I appreciate the follow-up question. I would love to talk about the historic trend line for Neuraceq, but those sales were not our audited numbers, so I really can't report on them too much. However, what I can say is we're seeing terrific growth from Neuraceq. October was an all-time high, and we expect that growth to continue. Bob MarshallCFO at Lantheus00:36:26Yeah. I mean, even to take it in from an inorganic perspective, they have been healthy growth rates. Bob MarshallCFO at Lantheus00:36:32I mean, let's just put it that. They've had a great year in 2025. We expect them to continue to grow from a market share opportunity perspective as we grow our PMF network, as Brian outlined in his prepared remarks. As well as bolstering the US sales team that came with the acquisition, who have all done a great job. We expect the opportunity from an expanded geographic presence to drive not only just the annualization of their contribution, but also to drive added value beyond that. Brian MarkisonCEO at Lantheus00:37:08I think what gives us a lot of confidence is the team from Life Molecular Imaging has been in the neuroscience space for quite some time. Their expertise is immediately grafted into our organization, and that gives us the ability to really hit the ground running and not lose any—there's no real downtime with them. Brian MarkisonCEO at Lantheus00:37:30It's been a seamless transition and integration with them, and we really cherish a lot of our new employees. Operator00:37:39Thank 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.Read moreParticipantsExecutivesBob MarshallCFOMark KinarneyVP of Investor RelationsBrian MarkisonCEOAnalystsPete LucasAnalyst at CJS SecuritiesAnalyst at B. RileyJustin WalshEquity Research Analyst at JonesTradingMatt TaylorManaging Director at JefferiesTara BancroftDirector, Senior Analyst, and Biotech Equity Research at TD CowenRoanna ReeseAnalyst at Leerink PartnersRichard NewitterManaging Director at Truist SecuritiesKemp DolliverDirector of Research and Senior Analyst at Brookline Capital MarketsPowered by Earnings DocumentsSlide DeckEarnings Release(8-K)Quarterly Report(10-Q) Lantheus Earnings HeadlinesWe Think You Should Be Aware Of Some Concerning Factors In Lantheus Holdings' (NASDAQ:LNTH) EarningsMay 15 at 9:14 PM | finance.yahoo.comLantheus Holdings (LNTH) price target increased by 10.39% to 103.33May 15 at 9:14 PM | msn.comYour book attachedBill Poulos is giving away his 'Safe Trade Options Formula' book for free - but only for a limited time through a temporary download link. He plans to charge for it soon. Download your copy now and lock it in at no cost, regardless of future pricing. | Profits Run (Ad)Lantheus Holdings, Inc. 2026 Q1 - Results - Earnings Call PresentationMay 15 at 7:07 PM | seekingalpha.comBig Pharma's 5 Hottest Biotech Hunting Grounds: Meet the Category LeadersMay 14, 2026 | 247wallst.comLantheus' (LNTH) Buy Rating Reaffirmed at Truist FinancialMay 12, 2026 | americanbankingnews.comSee More Lantheus Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Lantheus? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Lantheus and other key companies, straight to your email. Email Address About LantheusLantheus (NASDAQ:LNTH) is a global life sciences company specializing in the development, manufacturing and commercialization of diagnostic imaging agents and radiopharmaceuticals. Headquartered in North Billerica, Massachusetts, Lantheus focuses on products that enhance the detection and management of cardiovascular and oncologic diseases. The company’s portfolio spans ultrasound-enhancing agents, molecular imaging tracers for positron emission tomography (PET), and emerging theranostic platforms designed to pair diagnostic and therapeutic applications. The diagnostic imaging segment includes ultrasound contrast agents such as DEFINITY® (perflutren lipid microsphere) and Sonazoid® (perflubutane), which improve the visualization of cardiac structures and blood flow. On the molecular imaging side, Lantheus markets Cardiolite® (technetium Tc-99m sestamibi) for myocardial perfusion imaging and Lexiscan® (regadenoson) for pharmacologic stress testing. In 2021, the company gained FDA approval and launched PYLARIFY® (piflufolastat F 18), a PET imaging agent for the detection of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. Lantheus also maintains a robust pipeline of next-generation PET and therapeutic candidates in collaboration with academic and industry partners. Founded in 1956, Lantheus has expanded its reach through strategic acquisitions and global partnerships, serving hospitals, imaging centers and research institutions in more than 50 countries. The company operates a network of manufacturing facilities across North America and Europe, adhering to stringent quality and regulatory standards. Lantheus’ leadership team comprises experienced executives from the pharmaceutical and medical imaging industries, guiding the organization’s growth in precision diagnostics and targeted radiopharmaceutical therapies. Continuous investment in research and development underpins Lantheus’ mission to deliver innovative solutions that improve patient outcomes and drive value for healthcare providers worldwide.View Lantheus ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Peloton Stock Gives Back Gains After Upbeat Earnings ReportDatavalut Gains Traction: 5 Reasons to Sell NowTMC Stock: Why This Pre-Revenue Miner Is Worth WatchingRobinhood, SoFi, and Webull Are Telling Very Different StoriesViking Sails to All-Time Highs—Fundamentals Signal More to ComeYETI Rallies After Earnings Beat and Raised OutlookAeluma's Post-Earnings Dip Creates a Buying Opportunity Upcoming Earnings Palo Alto Networks (5/19/2026)Home Depot (5/19/2026)Keysight Technologies (5/19/2026)Analog Devices (5/20/2026)Intuit (5/20/2026)NVIDIA (5/20/2026)Lowe's Companies (5/20/2026)Medtronic (5/20/2026)Target (5/20/2026)TJX Companies (5/20/2026) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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PresentationSkip to Participants Operator00:00:00Morning. Welcome to Lantheus Third 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. Mark KinarneyVP of Investor Relations at Lantheus Holdings Inc.00:00:28Thank you. Good morning. With me today are Brian Markison, our CEO, and Bob Marshall, our CFO. We will begin with prepared remarks and then take your questions. This morning, we issued a press release, which was furnished to the SEC under Form 8-K, reporting our third quarter 2025 results. The release and today's slide presentation are available in the investor section of our website. Any comments could include forward-looking statements. Actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings. Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the investor section of our website. I will now turn the call over to our CEO, Brian. Brian MarkisonCEO at Lantheus00:01:18Thank you, Mark, and good morning, everyone. In addition to the earnings press release issued this morning, we announced a leadership transition plan to guide Lantheus into its next chapter of long-term growth. As a part of this plan, I will retire from Lantheus at the end of this year and transition into an advisory role. Mary Anne Heino, our current Board Chairperson and prior CEO, will assume the role of Executive Chairperson now and serve as interim CEO following my retirement. This structure allows Mary Anne and me to work closely together with our leadership team to ensure a smooth transition over the coming months. Mary Anne led Lantheus as CEO for nine years, driving significant growth throughout her tenure before becoming Chairperson in early 2024. Brian MarkisonCEO at Lantheus00:02:08With her extensive industry experience and deep knowledge of Lantheus, Mary Anne is well positioned to continue executing our strategy and driving momentum while we prepare for the expected launch of our new F 18 PSMA PET formulation. The board has initiated a comprehensive CEO search led by our lead independent director to identify and appoint our next CEO, who will build on our strong foundation. We also announced that our President, Paul Blanchfield, will be leaving Lantheus for a new opportunity. We thank Paul for his many contributions and wish him continued success in his new role. I would also like to note that Amanda Morgan will return from leave and continue in her role as Chief Commercial Officer, reporting directly to Mary Anne. Brian MarkisonCEO at Lantheus00:02:59Before Bob and I review the business performance, I want to express what an honor it has been to serve on the board and lead such a talented and purpose-driven group of employees at Lantheus. I am proud of our collective achievements and the remarkable progress we've made to strengthen Lantheus's position as the leading radiopharmaceutical-focused company. We executed a series of strategic transactions, including the acquisitions of Life Molecular Imaging, Evergreen Theragnostics, and Meilleur Technologies, along with key licensing agreements. These transactions diversified our revenue streams, expanded our capabilities across the radiopharmaceutical value chain, and positioned us for successful regulatory submissions. Most importantly, they enabled us to build a robust and innovative pipeline of radiodiagnostics, including advancing our position in the growing Alzheimer's disease imaging market and our early-stage radiotherapeutic products. Now turning to the Lantheus results. Brian MarkisonCEO at Lantheus00:04:07In the third quarter, our top priority was and remains executing our commercial strategy to maximize the long-term value of our prostate cancer franchise. Our PYLARIFY results for this quarter reflect our ongoing efforts to maintain a disciplined approach to pricing and to raise awareness of PYLARIFY's clinical differentiation. The pricing stabilization across our accounts that began early in the third quarter has continued, and actions we implemented in the second and third quarters to maintain our market leadership will continue to play out over time. Looking ahead, we are preparing for the potential approval of our new F18 formulation in 2026. We anticipate this will qualify for three years of transitional pass-through payment status, supporting our PSMA PET franchise growth beginning in late 2026 and into 2027. Now turning to PYLARIFY. Sales were $240.6 million during the quarter, down approximately 7% year-over-year, with U.S. Brian MarkisonCEO at Lantheus00:05:15Volumes up 3.3% and down slightly sequentially due to seasonality, both consistent with our expectations. Further to that point, large institutions continued to diversify their PSMA agents across PYLARIFY and Gallium-68 agents, while smaller accounts grew in line with market rates. Importantly, our educational efforts and customer feedback reflect increasing recognition of PYLARIFY's clinical value, and anecdotally, we are seeing some sites return after trialing alternatives. As I mentioned earlier, signs of pricing stabilization persisted throughout the third quarter and into October. We are preparing for the expected launch of our new F18 PSMA PET formulation, which optimizes the manufacturing process to potentially increase batch size by approximately 50%, which could enhance production efficiency, supply resilience, and enable increased patient access. We plan to introduce this new agent to the market following the receipt of coding, coverage, and reimbursement, including a HCPCS code and transitional pass-through payment status. Brian MarkisonCEO at Lantheus00:06:30We expect this plan to level the reimbursement playing field. For the remainder of 2025, we expect low single-digit volume growth offset by further price compression as 340B, or best price, resets in the fourth quarter as a result of the two-quarter lag in government price reporting, reflecting price concessions offered in the second quarter. Importantly, we do not anticipate any material changes to 340B from the fourth quarter into the first quarter of 2026. As PYLARIFY's in-market best price remained consistent from the second quarter to the third quarter of this year. These resets are factored into our guidance, and we are actively mitigating the impact through targeted commercial strategies. Our focus remains on preserving the long-term value of our PSMA PET franchise. DEFINITY continues to deliver consistent performance, growing more than 6% year-over-year despite experiencing slight unfavorable customer mix in the quarter. Brian MarkisonCEO at Lantheus00:07:40We remain confident in DEFINITY's market leadership and the continued growth of the ultrasound-enhancing agent market. DEFINITY's success continues to be anchored in its proven clinical and commercial value with a 24-year track record of clinical application and continued customer satisfaction. Turning now to our neurology franchise, we see significant growth potential in the U.S. Alzheimer's disease radiodiagnostic market, driven by rising prevalence, expanded PET imaging guidelines, and increasing use of amyloid beta and tau PET imaging agents alongside disease-modifying therapies. Today, there are two approved therapies and more than 100 in development, including approximately 30 tau-directed therapies and 40 beta-directed amyloid therapies, underscoring the critical role PET imaging can play in diagnosis and treatment selection. In the third quarter, Neuraceq delivered sales consistent with expectations. Brian MarkisonCEO at Lantheus00:08:47Neuraceq is our F18 PET imaging agent used to detect beta-amyloid plaques in patients being evaluated for Alzheimer's disease and select patients for amyloid beta-directed therapy, and is already enhancing the depth of our relationships with nuclear medicine customers and our manufacturing partners. Our strategy for Neuraceq focuses on three main priorities. First, expanding geographic coverage to ensure broad access across leading Alzheimer's centers and community practices, including with the recent addition of two new PMFs in Southern California and Illinois. Neuraceq has growing geographic coverage in the U.S. across 20 PMFs, and we plan to launch six additional PMFs in 2026. Second, improving availability and scheduling flexibility. Third, leveraging revised appropriate use criteria, or AUC, and updated benefit manager guidelines, which recommend repeat scanning. Brian MarkisonCEO at Lantheus00:09:50We are advancing MK-6240, our F18 PET imaging agent, for detecting tau in adults being evaluated for Alzheimer's disease, and the FDA has set a PDUFA date of August 13, 2026. Our NDA submission was supported by data from two pivotal phase three clinical trials, which evaluated MK-6240's performance in detecting tau pathology in early Alzheimer's disease. These studies met their co-primary endpoints of sensitivity and specificity to detect tau tangles. MK-6240 previously received fast-track designation, reinforcing its potential to address a significant unmet need in Alzheimer's disease diagnostics. We believe PET imaging is foundational to the diagnosis and management of Alzheimer's disease. The recent FDA approval of blood-based biomarkers is an important advancement, enabling earlier identification of patients. We believe these tests will expand the readily addressable market over time and complement, not replace, the critical value PET imaging provides in visualizing and quantifying disease. Brian MarkisonCEO at Lantheus00:11:06In addition to our work progressing our new F18 PSMA PET formulation and for MK-6240, we also are planning for potential approval of LNTH-2501, which is also known as Octavi, which is a PET diagnostic imaging kit targeting somatostatin receptor-positive neuroendocrine tumors, or as we commonly refer to them, NETs. If approved, LNTH-2501 may complement Lantheus's therapeutic candidate, PNT2003, as part of a theragnostic pair advancing the company's strategy to deliver integrated diagnostic and therapeutic solutions for patients with cancer. These four products strategically diversify our business and further solidify Lantheus's position as the nuclear medicine partner of choice. As we execute our strategy and advance our leadership in radiopharmaceuticals, we remain focused on delivering strong financial performance and disciplined capital allocation. To provide more detail on our third-quarter results and outlook, I'll now turn the call over to Bob. Bob MarshallCFO at Lantheus00:12:17Thank you, Brian, and good morning, everyone. Bob MarshallCFO at Lantheus00:12:21I'll provide details of the third-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 third quarter was $384 million, an increase of 1.4%. Radiopharmaceutical Oncology, currently PYLARIFY, contributed $240.6 million of sales, down 7.4%. U.S. volumes were up 3.3% year-over-year and down slightly sequentially due to seasonality, as expected. Precision diagnostic revenue of $129.7 million was up 25%. Highlights include sales of DEFINITY at $81.8 million, 6.3% higher, along with TechneLite revenue of $21.1 million, up 3.2%. Additionally, Neuraceq contributed $20.4 million in the abbreviated quarter. Lastly, strategic partnerships and other revenue was $13.7 million, down 10.1%. Driven mainly by our investigational product candidate, MK-6240, at $6 million of revenue, down 39.9%, due mainly to the timing of milestones received in the prior year quarter not repeated. Bob MarshallCFO at Lantheus00:13:33Gross profit margin for the third quarter was 63.5%, a decrease of 471 basis points. The decrease is mainly attributed to unfavorable pricing impacts to margin, the inclusion of Evergreen and LMI margin profiles, and E&O charges, which accounted for approximately 50 basis points of gross margin headwind in the quarter. Operating expenses at 32.4% of net revenue were 775 basis points higher than the prior year rate, but generally in line with previously guided underlying spending levels with the inclusion of both Evergreen and LMI, as well as additional investments in our R&D pipeline. Operating income for the quarter was $one one9.6 million, or a decrease of 27.6%. Other income and expense were $2.4 million of expense. This is slightly lower than expected due to a decreased cash position from the $100 million of shares repurchased during the quarter that resulted in lower net interest income to offset interest expense. Bob MarshallCFO at Lantheus00:14:34Total adjustments in the quarter were $74.8 million of expense before taxes. Of this amount, $24.5 million and $14.6 million of expense is associated with non-cash stock and incentive plans and acquired intangible amortization, respectively. Non-recurring expenses tied to closing and integrating our announced acquisitions and divestiture totaled $34.8 million. Our effective tax rate was 26.9%. The resulting net income for the third quarter was $27.8 million and $85.7 million on an adjusted basis, a decrease of 30.9%. GAAP fully diluted earnings per share for the third quarter were $0.41 and $1.27 on an adjusted basis, a decrease of 25.3%. Now turning to cash flow, third-quarter operating cash flow totaled $105.3 million, down $69.8 million from the prior year. The variance is driven in part by M&A fees and integration cash costs incurred in the quarter of $35.1 million. Capital expenditures totaled $10.6 million, down $5.2 million. Bob MarshallCFO at Lantheus00:15:43Free cash flow, which we define as operating cash flow less capital expenditures, was $94.7 million, $64.6 million lower than the prior year period. During the quarter, the company invested $100 million in its own shares at an average price of $56.94 for 1.756 million shares. Also, the company completed the acquisition of Life Molecular Imaging with an outlay of approximately $309 million net of cash acquired. Taken together, cash and cash equivalents, net of restricted cash, now stand at $382 million. We have access to our $750 million undrawn bank revolver and are comfortable with our strong liquidity position. Turning now to our updated guidance for the full year of 2025, we are narrowing our view of full year revenue to the higher end of the range to reflect recent trends we saw throughout Q3 as well as quarter to date. Bob MarshallCFO at Lantheus00:16:39Principally, we estimate that PYLARIFY will come in toward the higher end of the prior range of $940 million-$965 million. Neuraceq's contribution should also trend to the higher end of the prior range. Taken together, full year revenue is now expected to be in a range of $1.49 billion-$1.51 billion from the prior range of $1.475-$1.51 billion. We are also narrowing our estimates of adjusted EPS to a range of $5.50-$5.65 versus the prior guide of $5.50-$5.70. With that, let me turn the call back over to Brian. Brian MarkisonCEO at Lantheus00:17:17Thank you, Bob. As I mentioned earlier, I look forward to collaborating with Mary Anne and the board over the coming months and supporting Lantheus in an advisory role after retiring. In the meantime, I remain committed to advancing and executing our strategy. Brian MarkisonCEO at Lantheus00:17:35This includes continuing to build on Lantheus's strong leadership position in radiopharmaceuticals. We're staying laser-focused on driving PYLARIFY commercial execution as we prepare for the next chapter of our prostate cancer franchise. We're also advancing our strategic diversification plan, including the ongoing integration of our recent acquisitions and preparing for four near-term product approvals that we expect to fuel our next wave of growth. The talented teams from Life Molecular Imaging and Evergreen significantly strengthen Lantheus's ability to execute operationally and commercially and ultimately allow us to expand our patient impact. We're advancing our innovative investigational assets across oncology, neurology, and cardiology and expanding our commercial portfolio that enables clinicians to fight, follow disease to deliver better patient outcomes. It's been a privilege to lead Lantheus as CEO. Brian MarkisonCEO at Lantheus00:18:36Together, we have built a robust radiodiagnostic and radiotherapeutic pipeline, positioned Lantheus for successful regulatory submissions, and strengthened our capabilities and expertise in the growing Alzheimer's disease radiodiagnostic market and across the radiopharmaceutical value chain. I'm confident that Lantheus is well-positioned to drive long-term growth and enhance value for all our stakeholders. With that, operator, I'll now turn it over to questions and answers. Thank you. Operator00:19:09As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One question per person, please. Please stand by while we compile the Q&A roster. Our first question comes from the line of Roanna Reese from Leerink Partners. Roanna ReeseAnalyst at Leerink Partners00:19:38Great. Good morning, everyone. I want to extend my best wishes to you, Brian, on your next endeavor. A quick question for me. Roanna ReeseAnalyst at Leerink Partners00:19:48I noticed on you were talking about the PYLARIFY and Neuraceq likely being in the higher end of range of guidance based on trends in the quarter and to date. I was curious if you could elaborate on those, what strategies are getting traction here, and how could those continue into 2026. Thanks, Brian MarkisonCEO at Lantheus00:20:10Roanna. I'll take the beginning of it and then flip it to Bob. By the way, welcome back and congratulations to you. I think what you're seeing with PYLARIFY is, as we've reflected in the prepared remarks, a stabilization in the PSMA market. We have, I would think, weathered the storm appropriately with execution as we changed from an ASP reimbursement environment to one of MUC. We're seeing customers that are trialing different agents actually come back to PYLARIFY, and that's quite rewarding. With Neuraceq, it's really all about expansion and availability. Brian MarkisonCEO at Lantheus00:20:53It's a great amyloid tracer. Under the Life Molecular Imaging umbrella, it has not had the resources to expand in a way that we have with PYLARIFY. It is all about, for us, availability, expansion, being there for our customers, and also driving our portfolio. Bob, do you care to comment? Bob MarshallCFO at Lantheus00:21:12Yeah. I mean, to kind of tack on to that, the visibility that we have as we look to the balance of this year, obviously, our focus is on executing the strategy that we've had in place, which we will continue to do. It is still a competitive market, and we will continue to monitor that extremely closely, particularly as we go into the new year. Bob MarshallCFO at Lantheus00:21:33I'm not going to comment on 2026 as we're not in a place to provide guidance, but when we do, it'll take into consideration all the different market and environmental dynamics that we see at that time. Operator00:21:44Thank you. One moment for our next question. Our next question comes from the line of Richard Newitter from Truist. Richard NewitterManaging Director at Truist Securities00:21:55Hi. Thanks for taking the questions. I wanted to just ask, actually, a couple. I know you're not giving 2026 guidance, but is there, I think investors are definitely focused on the possibility of any major resets coming. So anything you can highlight relative to where you see consensus? I think consensus earnings is around $575 for next year, and PYLARIFY is hovering a little over $900 million. Sounds like with the step up in visibility today around PYLARIFY, that might not be a bad place to be. Richard NewitterManaging Director at Truist Securities00:22:38Anything you can comment on 2026, even if it's just directional relative to consensus, it would be helpful. Thank you. Brian MarkisonCEO at Lantheus00:22:44Yeah, Rich, I appreciate the question. We're not going to comment on 2026 guidance. I think what we can tell you and what we're seeing in the market right now is the stabilization of our account base. We're also seeing continued year-over-year and sequential volume growth for PYLARIFY. We're seeing a lot of promising signs as we focus on growing the market, preserving the growth, and preparing for our launch of our new formulation. Operator00:23:20Thank you. One moment for our next question. Our next question comes from the line of Matt Taylor from Jefferies. Matt TaylorManaging Director at Jefferies00:23:28Hi. Good morning. Thanks for taking the question. I was hoping just because there's a lot of significant management changes, you could talk a little bit more about. Matt TaylorManaging Director at Jefferies00:23:40Why now in terms of retiring, why Paul's leaving, and I guess what you're looking for in a new CEO and how long that process could take. Brian MarkisonCEO at Lantheus00:23:48Yeah, thank you. I appreciate the question. First, let's uncouple the two management changes with Paul and Brian. Paul is going to a great opportunity. It's wonderful. We're excited for him. It's also gratifying to Lantheus that we continue to churn out some great executives into the marketplace. As for me, my decision's personal. I've got nine grandchildren, and actually, I think number nine was the tipping point for me. When I came into the role, it was not with any expectation that this would be a long-term assignment, and that I came in to rebuild a pipeline, rebuild an R&D organization, and position this company for sustained long-term growth. I feel really, really good about doing that. Brian MarkisonCEO at Lantheus00:24:37It is time for me to step aside. The other thing that is really good here that we should take note of is that Mary Anne is very close to this business. She was the CEO for nine years. She has been part of it as a board chair for the past two years, and we have worked very closely together for the past 13 years. This is a seamless transition with an expert who is coming back in on an interim basis as we have also announced a CEO search. Our lead independent director is heading up that search. It will be comprehensive. Obviously, we are looking for outstanding individuals that can take this company to the future. How long the process will take, I cannot determine that. Right now, it is very early in stages. Brian MarkisonCEO at Lantheus00:25:25You can look at industry averages from announcements like this to time of new placement, and you can figure it out for yourself. This is a very attractive role for an up-and-coming, rising CEO candidate. I have no question that we are going to find an outstanding person to come in here and build for the future. Thank you. One moment for our next question. Operator00:25:48Our next question comes from the line of Paul Choy from Goldman Sachs. Paul Choy from Goldman Sachs, your line is now open. Please proceed. One moment for our next question. Our next question comes from the line of Yuan Zhu from B Riley. Operator00:26:16Thank you for taking our questions. What was the advantage of F18-labeled PYLARIFY? They are produced in 20 or 40 doses per batch. Operator00:26:28Since competitor GOZELLIX came to the market, do you notice that they are producing in cyclotrons with a similar number of doses per batch and taking market shares away from your high-volume customers? Thank you. Thanks, Juan. I appreciate the question. We're not seeing a lot of impact from GOZELLIX produced on a cyclotron. We're seeing, actually, as I mentioned in the prepared remarks, very good and consistent growth with our smaller accounts that have more capacity and that are growing with the market. We are seeing in our much larger accounts those sharing, if you will, with Gallium-68. Those are the accounts that have a tremendous amount of volume. We are not seeing any real impact that I can measure right now from GOZELLIX on a cyclotron. I'm not at the moment concerned about that. Operator00:27:21Thank you. One moment for our next question. Operator00:27:28Our next question comes from the line of Larry Solo from CJS Securities. Pete LucasAnalyst at CJS Securities00:27:34Hi. Good morning. It's Pete Lucas for Larry. Just one question. If you could give us a little more color on the competitive landscape in the Alzheimer's imaging market, particularly on the tau tangle side of the market, and how MK-6240 is positioned against other products. Brian MarkisonCEO at Lantheus00:27:51Yeah. Thanks, Pete. Great question. So again, MK-6240 has been filed with an expected PDUFA date of August 13, 2026. I think we look at MK-6240 as a second-generation tau agent. Talvet is the only agent commercially available today. There is a lot of interesting information out of different clinical trials, one notably the head study out of the University of Pittsburgh, where they directly compare these tracers, all the tau agents, whether they're investigational or the one commercially available, head-to-head, if you will. Brian MarkisonCEO at Lantheus00:28:34The superiority of MK-6240 is in evidence and reported in these studies, and we have discussed it in previous earnings calls. I think the major thing to look for here as the marketplace evolves and guidelines evolve. Clearly, the role of tau is going to become increasingly more important as you look at staging, longitudinal management, and tracking. What tau gives you the ability to do is look at where in the brain the tangles are, if you will, and what parts of the brain are they affecting, and how does the patient with AD really behave, whether it is memory, whether it is balance, whether it is speech. All of these things come into play when looking at tau and assessing its disposition in the brain of an Alzheimer's disease patient. We feel that MK has a significant competitive advantage. Brian MarkisonCEO at Lantheus00:29:33However, I would like to point out that the market is relatively immature for tau, and the beta-amyloid market is really exploding right now in front of us. Operator00:29:42Thank you. One moment for our next question. Our next question comes from the line of Tara Bancroft from TD Cowen. Tara BancroftDirector, Senior Analyst, and Biotech Equity Research at TD Cowen00:29:53Hi. Good morning. I am wondering if you could tell us more about the various factors and maybe feedback that you are hearing from your partners that are leading the market to reach this pricing stabilization exactly. Then, along that line, do you believe that this will remain kind of a three-player market in the near term, like into 2026, given the various pass-through dynamics that are expected next year for you and for others? Thanks so much. Brian MarkisonCEO at Lantheus00:30:22Yeah. In the near term, I expect it to be a three-player market. I think. Brian MarkisonCEO at Lantheus00:30:30In a competitive market like ours, and given the success we've had. Simply looking at the revenues we reported for PYLARIFY, you naturally do attract competition. We think the stabilization we're seeing, and our description of our strategy to be disciplined on price, has played through in the marketplace with our accounts and our customers. The other thing to note is our service is top-notch. Our ability to deliver doses on time in full is unparalleled. I think that service quotient and our team in the field, along with our PMF partners, needs to be recognized as part of our success. It is not simply introducing another agent. It is also having the feet on the street and the knowledge that we have to really execute. The other part of this, though, is the clinical differentiation of PYLARIFY is really beginning to shine, if you'll excuse the pun. Brian MarkisonCEO at Lantheus00:31:30I think in patients with low-volume disease where they're suspected of a recurrence or even on initial staging and diagnosis, PYLARIFY has a very clean and distinct signal, and its sensitivity and specificity are really unparalleled. You could just look at the other competitors' package inserts to compare them. In all, I believe this market stabilization we're seeing now is healthy. I think that customers are making the right decision for their patients, and I think our team in the field is really rocking it. I expect continued growth out of this franchise. Operator00:32:12Thank you. One moment for our next question. Our next question comes from the line of Justin Walsh from JonesTrading. Justin WalshEquity Research Analyst at JonesTrading00:32:21Hi. Thanks for taking the question. What are your thoughts on the potential dynamics that could emerge in the PSMA imaging market as other clinically differentiated products enter? Justin WalshEquity Research Analyst at JonesTrading00:32:31I know one potential competitor has a copper-64-based agent in late-stage development, and it would be great to hear how Lantheus will maintain your edge in the space. Yeah. I think the copper-64 agent is certainly of interest to us, and we are monitoring their progression carefully. I think when you look at real differences in the clinic, that will have to play out. But we're highly confident that our sensitivity and specificity at our network will continue to be the major force in the marketplace. We're watching it very carefully, and I really don't have too many concerns at the moment about that. Bob MarshallCFO at Lantheus00:33:16Justin, I'll just tack on. I just think that you're also talking about it launching into what we believe will be a continuing market opportunity. A rising tide lifts all boats. Bob MarshallCFO at Lantheus00:33:28Certainly, if there's a carve-out share for them, it would be into a market that is going to approach $3.5 billion plus by the end of the decade. A lot of that predicated on the growing use from an RLT perspective. Justin WalshEquity Research Analyst at JonesTrading00:33:46Right. Let's leave it at that. Operator00:33:51Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our next question comes from the line of Kemp Doliver from Brookline Capital Markets. Kemp DolliverDirector of Research and Senior Analyst at Brookline Capital Markets00:34:14All right. Thank you. And good morning. Brian, what are you thinking regarding the pending Medicare hospital outpatient rule, which A is overdue, and then also the possibility that they will transition to ASP from MUC? Thanks. Yeah. Brian MarkisonCEO at Lantheus00:34:39I think when you look at the end of last year, there was a moment in time where we had ASP, then we did not, then we had it again, and then we did not. Now we are in the MUC environment. I think the Hill is a bit in disarray at the moment. However, we continue to lobby, we continue to work with CMS, and we are continuing to educate them. I think the belief out there, and certainly we share this, is that moving to ASP eventually is the right move for all parties involved. It simplifies everything from both our end and from CMS. However, I think at the moment, with a bit of a disarray, it is hard to break through and have your voice heard. I think for 2026, I am not anticipating much change, but certainly for 2027. Brian MarkisonCEO at Lantheus00:35:29We are predicting that there could be meaningful change to ASP. Operator00:35:32Thank you. One moment for our next question. Our next question comes from the line of Yuan Zhu from B. Reilly. Operator00:35:44Follow-up from us. Now your acquisition is complete. Can you provide additional color on the growth trajectory from the past and looking forward, as well as your plan to gain market share there? Thank you. Brian MarkisonCEO at Lantheus00:36:00Yeah. I appreciate the follow-up question. I would love to talk about the historic trend line for Neuraceq, but those sales were not our audited numbers, so I really can't report on them too much. However, what I can say is we're seeing terrific growth from Neuraceq. October was an all-time high, and we expect that growth to continue. Bob MarshallCFO at Lantheus00:36:26Yeah. I mean, even to take it in from an inorganic perspective, they have been healthy growth rates. Bob MarshallCFO at Lantheus00:36:32I mean, let's just put it that. They've had a great year in 2025. We expect them to continue to grow from a market share opportunity perspective as we grow our PMF network, as Brian outlined in his prepared remarks. As well as bolstering the US sales team that came with the acquisition, who have all done a great job. We expect the opportunity from an expanded geographic presence to drive not only just the annualization of their contribution, but also to drive added value beyond that. Brian MarkisonCEO at Lantheus00:37:08I think what gives us a lot of confidence is the team from Life Molecular Imaging has been in the neuroscience space for quite some time. Their expertise is immediately grafted into our organization, and that gives us the ability to really hit the ground running and not lose any—there's no real downtime with them. Brian MarkisonCEO at Lantheus00:37:30It's been a seamless transition and integration with them, and we really cherish a lot of our new employees. Operator00:37:39Thank 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.Read moreParticipantsExecutivesBob MarshallCFOMark KinarneyVP of Investor RelationsBrian MarkisonCEOAnalystsPete LucasAnalyst at CJS SecuritiesAnalyst at B. RileyJustin WalshEquity Research Analyst at JonesTradingMatt TaylorManaging Director at JefferiesTara BancroftDirector, Senior Analyst, and Biotech Equity Research at TD CowenRoanna ReeseAnalyst at Leerink PartnersRichard NewitterManaging Director at Truist SecuritiesKemp DolliverDirector of Research and Senior Analyst at Brookline Capital MarketsPowered by