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TRVI 2025 Q3 财报电话会议

Operator: Good afternoon, and welcome to the Trevi Therapeutics Third Quarter 2025 Earnings Conference Call. At this time, please press one on your phone. Please note this event is being recorded. Various remarks that management makes during this conference call about the company's future expectations, plans, and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by the forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of the company's most recent quarterly report on Form 10-K, which the company filed with the SEC this afternoon. In addition, any forward-looking statements represent the company's views only as of today and should not be relied upon as representing the company's views as of any subsequent date. While the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so if its views change. I would now like to turn the conference over to Jennifer Good, Trevi's President and CEO. Please go ahead. Jennifer L. Good: Good afternoon, and thank you for joining us for our third quarter 2025 earnings call and business update. Joining me today on this call are my colleagues, Dr. James Cassella, our Chief Development Officer, and Farrell Simon, our Chief Commercial Officer. I will make some comments on the business and financial results, then the team is happy to answer any questions you may have. The first half of this year was a major inflection point for Trevi Therapeutics, Inc. With positive data readouts in both the CORAL trial for chronic cough in patients with idiopathic pulmonary fibrosis or IPF and the RIVER trial for patients with refractory chronic cough or RCC. We recently presented these results at CHEST, and it was great to see the interest from leading thought leaders and community pulmonologists. As a result of these strong data, we were able to raise approximately $100 million in June, giving us cash runway into 2028 and an ability to execute on the next clinical studies for each indication. It is an exciting place to be in our development, and we have not wasted any time in moving forward. Let me provide a brief update on what the team has been up to in each of our chronic cough indications. We have recently completed a couple of important Phase I studies to advance our IPF cough program. The FDA requested we conduct a drug-drug interaction study looking at any potential PK interactions when Nalbuphine ER is co-administered with pirfenidone or nintedanib, which are anti-fibrotic and the standard of care taken by patients with IPF and other progressive fibrotic diseases. We recently received the data from this study, and we are pleased that there were no clinically meaningful changes in the pharmacokinetics of any of the drug combinations used in this study. We will publish these data in the future, but we did not see anything that will impact the dosing in our Phase III program. We also made good progress on our TITLE study, which is assessing respiratory function and safety of Nalbuphine ER in IPF patients. Recall, this is a study requested by the FDA to investigate if there were any potential signs of respiratory depression in patients with IPF following dosing with Nalbuphine ER. The IPF patients in the study were housed in clinic for ten days and given increasing doses of the drug while having their oxygen, carbon dioxide levels, and respiration rate assessed for periods of time. A planned review of data by an external safety review committee in a sentinel cohort of patients concluded that there were no safety signals in the study to date. As a result, the committee gave approval to complete enrollment for the study. We will include the available data for both the DDI and respiratory safety studies in the end of Phase II meeting package. As for the end of Phase II meeting, we expect to request that meeting in the fourth quarter of this year. The key points we are looking to discuss with the FDA are to gain alignment on the Phase III program for chronic cough in patients with IPF, get their input on the Phase III study design and other parameters, as well as agree upon any other NDA enabling work which needs to be completed. In parallel, the clinical team has been preparing to initiate the Phase III program in the first half of next year and is busy lining up key vendors and identifying sites for these global studies. We have also been preparing for a study in other non-IPF interstitial lung diseases, or ILD. This population will include non-IPF ILD patients that have lung fibrosis and chronic cough. We estimate there are approximately 228,000 of these patients, with 50% to 60% having uncontrolled cough. This more than doubles the market opportunity of IPF chronic cough, and these patients are primarily seen by the same pulmonologists as IPF patients. This keeps our clinical and commercial efforts efficient and creates synergies. We plan to request a meeting with the FDA once we align on the IPF pivotal program to discuss our study design and protocol for this indication as well. Once we have FDA input, we will be prepared to initiate this study. Finally, we have been working on the next study in refractory chronic cough. We expect that study to be a Phase 2b parallel arm dose-ranging study and are planning to initiate that study in the first half of next year. We are drafting the protocol and identifying sites for this study as well. So as you can see, there's a lot of planning going on at Trevi Therapeutics, Inc., as well as preparation work to align with the regulatory authorities and initiate multiple trials in the first half of next year. This takes time to ensure that we get these trials right. We will provide updates on next steps as we gain alignment and have line of sight to study starts. I will now provide a quick review of the financial results for the quarter. The full financial results for the three months ended September 30, 2025, can be found in our press release issued ahead of this call and our 10-Q, which was filed with the SEC today after the market closed. For the third quarter of 2025, we reported a net loss of $11.8 million compared to a net loss of $13.2 million in the same quarter in 2024. R&D expenses decreased to $10.1 million during the third quarter of 2025 from $11.2 million in the same quarter last year. The reduction was primarily due to decreased clinical trial work in which those trials were actively enrolling in the prior year and reported data in the first half of this year. This was partially offset by increased costs related to our recently completed Phase I studies and personnel and related expenses. Farrell Simon: The increased professional fees were primarily due to increased costs as we continue to prepare for compliance with SOC 404 regulations. As of September 30, 2025, our cash and investments totaled approximately $195 million. Our cash and investments give us cash runway into 2028, subject to finalizing the development for each of our indications. We expect to be able to fund two Phase III trials of Hiduveo for the treatment of chronic cough in patients with IPF, along with a long-term extension for those trials. Our planned Phase 2b/3 trial in chronic cough in patients with non-IPF ILD, our next trial in patients with RCC, and our ongoing Phase I supportive studies. So in closing, Trevi Therapeutics, Inc. is positioned with strong data in two serious chronic cough conditions and is preparing to advance into the next stage of development for each of the three chronic cough indications. Chronic cough is a debilitating condition for which there are currently no FDA-approved therapies. Also, the company is financially strong with enough cash to complete the next stage of development work to potentially advance these therapies closer to the patient. We believe we are well-positioned to execute our strategy and create meaningful shareholder value over the next couple of years. This concludes my prepared remarks. Jim, Farrell, and I are now happy to answer your questions. I will turn the call back over to the operator for Q&A. Operator: We will now begin the question and answer session. The first question comes from Ryan Deschner with Raymond James. Please go ahead. Ryan Phillip Deschner: Hi, thank you very much for the question. Have you narrowed down more of what inclusion and exclusion criteria you would target for the non-IPF ILD study, maybe in terms of what constitutes chronic cough in those studies? And would you exclude any ILDs from an initial study in this space off the bat? Thank you. James V. Cassella: Hi Ryan, this is Jim. So thanks for the question. We had some good discussions with our KOLs for the non-IPF ILD study. I think you can imagine that there's going to be a lot of similarity in the underlying lung disease. We'll define that in a certain way. Chronic cough, I think we're going to go in with the standard criteria. Typically, we look at some minimum amount of cough in terms of maybe 10 coughs per hour. So it'll be very consistent with what we're looking at in the rest of our program. So I think those are narrowing down rather nicely. I think the important point to remember about that type of trial is that while there are going to be patients with lots of other comorbid conditions, we're really focusing on the entry criteria being related to the amount of cough that they have and the amount of lung damage, lung fibrosis that they have. So those are going to be the defining features for the inclusion. And then there'll be other things to manage around their comorbid conditions. Jennifer L. Good: And Jim, anything we're carving out? James V. Cassella: At this point in time, we're not really carving out anything. We're going to base it on those basic criteria. So of course, it's a broad swath of conditions. And as we get closer to that, inclusion or it's closer to defining that protocol a little bit more in-depth, we may carve out one or two, but for the most part, it's going to be based on lung disease and the amount of cough. Ryan Phillip Deschner: Excellent. Very much. Maybe quickly just on the DDI study, would you anticipate needing to do any more studies like that for a trial like this or subsequent trials? Outside of, I guess, chronic cough and RCC. James V. Cassella: Yeah, so that's great, Ryan, thanks. So the study we got done was a DDI looking at our drug with pirfenidone and nintedanib as the key antifibrotics in this space. There will be other DDI studies that we will have to do based on the mechanism of drug metabolism. We are metabolized by CYP, primarily the 2C9, 2C19 species. So there will be a DDI looking at probably a 2C9 inhibitor. These are things that we'll talk with the FDA about, but it is expected that we will have to do a couple more Phase I studies and at least one more DDI study. Ryan Phillip Deschner: Thank you very much. Operator: And the next question comes from Annabel Samimy with Stifel. Please go ahead. Annabel Eva Samimy: I just wanted to clarify for the respiratory study, you had interim results from the DSMB saying that you have no issues. Do you need to complete that study before you have the end of Phase II meeting with the FDA? And is there any other hurdle that you need to get past for that meeting? And then separately, if you could just share a little bit of the feedback that you've been hearing from the CHEST meeting at this point, how are the pulmonologists looking at this? And how do you start thinking about targeting the market that you're looking at? Thanks. Farrell Simon: Hi, Annabel. So on TITLE, we had a sentinel cohort of four subjects that we completed. And the plan was to have our data monitoring committee review those subjects. That all went fine. There were no safety issues identified. So we continued on. To answer your question, we will have the available data when we submit the package. Jennifer L. Good: Really hasn't been a lot of work done on things that matter day to day to the patient. So we're getting a lot of attention in our sessions. The data has gotten a lot of attention. And we also hosted a reception one night that was very well attended by U.S. investigators interested in getting into our study. So, really encouraging. Jim and I were both there and quite busy the whole time. I think, Sarah, I'll let you take on sort of based on the feedback how you might be thinking about targeting the market with any feedback. Farrell Simon: Yes. Thanks, Annabel, for the question. When we look at the market, we do need to raise the burden of disease, and that's work that's ongoing. That we're continuing and we'll launch next year. There's also just targeting in terms of how we look at segmenting this market, which will start next year just to make sure that we have appropriately sized our field force to target the key prescribers in this area. So that's some of the work, and then we're continuing to always do physician and payer research to understand how our new target product profile based on the positive core results is seen by physicians and payers within this space. Annabel Eva Samimy: Great, thank you. Operator: And the next question comes from Leland Gershell with Oppenheimer. Please go ahead. Leland Gershell: Great. Thanks for the update and taking the questions. Just a couple, joined a little bit late, so my apologies if you may have covered. But as you head into the end of Phase II meeting, Jennifer, are there any particular questions or issues that you would like to address for your clarity on? Then also wanted to ask on the drug-drug interaction side, is there any need for Trevi to run interaction studies within patients who may be on other opioids concomitantly? Thank you. James V. Cassella: Leland, this is Jim. So in terms of the end of Phase II meeting, standard questions are going to be related to the protocol design, endpoints, duration of the study, really nuts and bolts around the Phase III. We'll be submitting a full final draft protocol to them, so we'll have the protocol with them in hand. And we will guide some of the more important questions regarding the design, patient inclusion, exclusion criteria, our statistical approach, pretty basic things that are really important to narrow down at this meeting. So we will have absolute clarity on what we need to do for the Phase III coming out of that meeting. Jennifer L. Good: Safety database size too is an important one. James V. Cassella: Safety database size, we will be discussing the extent of any long-term data collection. And we'll also be, as we've talked about the DDI study, we did talk that we may need to do some more work in the Phase I world on wrapping up things for the NDA submission. We will probably do another drug-drug interaction study that encompasses our mechanism of drug 2C19 in particular. So we'll be asked to do a drug-drug interaction study with drugs that are inhibitors of that system to understand what the effects are on pharmacokinetics. There might be some other Phase I studies that we're anticipating that we will discuss with the FDA at the end of Phase II meeting as well. Jennifer L. Good: I would add though, Leland, I think you specifically asked about other opioids. They are contraindicated. We have excluded them because as you know, our mechanism is a mu antagonist. So if you're on other opioids, it will put you into opioid withdrawal, which is obviously super helpful from the addiction side and labeling side. But we do contraindicate that in our trials and it will be in our label. Leland Gershell: Yes. Thank you, Leland. Operator: And the next question comes from Judah Farmer with Morgan Stanley. Please go ahead. Judah Farmer: Yes. Hi, guys. Thanks for taking the questions. Maybe could you help us with the latest thinking on the potential to incorporate the non-IPF ILDs into the Phase III program for IPF. Will you get any clarity on that at the end of Phase II, do you think, or do you have to wait for that subsequent interaction? And then what are your thoughts on launching with both indications in the same label versus sNDA? And then secondarily, obviously, high level, but any thoughts on changes in CBER leadership and impacts of the programs? Thanks. Jennifer L. Good: I'm just going to comment on strategy. We could probably both do this. But I think, Judah, we made a decision that we're going to go in with sort of our strongest foot forward and do the end of Phase II meeting. Jim's got a lot of data, robust data. We want the FDA to catch up with where we are, all the studies we've run, the data we've generated. And we will tease up there that our broader program includes both RCC, but importantly non-IPF ILD, which we think shares a common biology. So we will tee that up, but you only get one hour in this meeting, and we don't want to get distracted debating non-IP ILD there because to Jim's point, we need to walk out with clear guidance on our Phase III program. So really trying to protect that and keep it whole. As soon as we feel we have alignment with the agency, we're going to be prepared to submit a protocol and non-IPF ILD and request a Type C meeting. Hopefully, that's a pretty easy ask coming off the heels of the IPF end of Phase II. So that was sort of a strategy point because we could have jumped in earlier, but felt we wanted our strongest foot forward. I mean, as far as the sort of CBER change in leadership, and I'll let Jim add any color as well. I mean, obviously, a new person named this week, an oncology person, I don't know how much that's really affecting the divisions we've had. I mean, baffling to me, timely feedback, on time, clear communications. I don't know how the FDA is holding it together. Kudos to them. So I don't know how much those levels are affecting things. When you're in a clinical trial mode. I'm sure at the point in time they look at your NDA it does. But hasn't seemed to impact what we're doing. I don't know, do you have anything to add? James V. Cassella: No, nothing to add to that other than I think the surprise factor of how responsive they've been is has been high on my list. It's like this is very unusual for me to get this kind of responsiveness. So very pleased about that. Judah Farmer: Great. Thank you, Judah. Operator: And the next question comes from Serge Belanger with Needham and Company. Please go ahead. Serge D. Belanger: Hi, good afternoon. I think in the past you've discussed the potential of HYDUVIO being eligible for orphan drug exclusivity in IPF cough. Just curious if you have any updated thoughts on that and whether that's something you will seek like an orphan drug designation in the upcoming end of Phase II meeting with FDA? Thanks. Jennifer L. Good: Jim's laughing because he made me promise. We are going to request orphan drug for IPF. I do always warn people that, you know, I don't want people to put too much in that. Although IPF has gotten orphan drug. This is cough in IPF and cough is a broad problem. So we'll see what they have to say. So we will apply, I think it's an answer we should know. Jim made me promise that we wouldn't do that until after we went through our end of Phase II meeting. He doesn't want them to be distracted on any other side questions. So I think on the heels of end of Phase II, we'll go ahead and submit for that and find out their views on cough and IPF. Serge D. Belanger: Thank you. Operator: And the next question comes from Rowena Ruiz with Leerink Partners. Please go ahead. Rowena Ruiz: Great. Good afternoon, everyone. So a couple for me. First one is given the evolving IPF landscape with recent positive data from United Therapeutics TETON study, I was curious how could that impact how Haduvia fits into the prescribing approach and treatment algorithm of physicians? Michelle, you want to take that or I can as well? Farrell Simon: Yeah, happy to. Thanks, Rowena, for the question. If anything, it probably doesn't really change much for us. When you think about chronic cough, the high burden of disease among these patients, physicians look at this as either first or second line therapy, and that can be before an anti-fibrotic or after an anti-fibrotic is initiated. When you look at the drugs and the new approvals that are already coming to market, they're still slowing the progression of the disease and they're not having a positive impact on the cough. So there's still a very high place for a chronic cough therapy and concomitant therapy with these anti-fibrotic products that are on the market or potentially coming to market. Jennifer L. Good: And so I would just add too, I've heard a lot of discussion about, you know, with improvements in therapies and treatments for patients, it probably just improves the diagnosis. So the patient groups will start to grow, I think people are focused on this disease a little more. Hopefully, cough comes to the forefront when we actually have something for treatment. So it's obviously great for the patient to have options. But I just think overall, it probably grows the market as well. Rowena Ruiz: Yep. Makes sense. And a quick follow-up about the TITLE study. What do you hope to see in the results in terms of a best-case scenario now that you can complete enrollment? And any sort of thoughts on how that might impact the end of Phase II discussion with the FDA? James V. Cassella: Yes. Hi, this is Jim. So we are looking at basic respiratory function, PO2, CO2, and respiration rate. FDA was interested in a study like this just to make sure that we don't have any blatant signals regarding respiratory depression. So we're taking a very fundamental approach on key respiratory parameters and looking at those. The ideal outcome for this study and the data have been great so far is that there's no findings here. There would be no findings, meaning that there's no changes on any of those parameters. We are dosing at night, looking at these IPF subjects while they are asleep, which is considered a conservative way, the most sensitive approach to this. So that's the nature of the study to really pull out if there's anything there. So obviously clean results and no impact on the program is the ideal outcome. Ideal here. Jennifer L. Good: Jim, I would just add. We've obviously had this in what two hundred people now, IPF patients clinically. And never seen any signal. So I think this will just sort of go hand in hand with the safety database they look at as well. Rowena Ruiz: Makes sense. Thanks. Jennifer L. Good: Thanks, Rowena. Operator: And the next question comes from William Wood with B. Riley Securities. Please go ahead. William Wood: Hi, thanks for taking our questions today. So a couple from us, kind of focused on the Phase III. It sounds like from what I can tell you, you've essentially got your sort of Phase III package sort of put together in terms of how you want it. Obviously, that's got to be discussed with the FDA and approved or at least agreed upon. But I was just curious if you could walk through sort of maybe what you're thinking at a high level in terms of doses and or timing titration you're looking to take forward? And maybe just remind us are you going to allow patients to use background anti-fibrotic in the study? And will you be looking at a biomarker improvement within the study? And then lastly, just briefly, would this be conducted in the same sites that your other Phase IIs were, or will you be branching out further? James V. Cassella: Sure. I think I can remember all those. I got them written. I got them down. So William, thanks. This is Jim. So in terms of doses, we did CORAL was a great study for us because we learned a lot from it, including that was our definitive dose-ranging study. So in terms of dose going forward, we did a lot of work over the summer. We interrogated the fifty-four and the one hundred eight-milligram dose group in CORAL because of the titration up, we were able to determine in individual subjects and looking at dosing groups. At the one hundred eight, really didn't add any significant value to the fifty-four milligram BID dose. So fifty-four milligram BID will be our top dose going forward. Twenty-seven milligram BID dose is a titration dose. We identified that as a minimum effective dose in the CORAL study. So it will not be considered a treatment dose, but it will be considered a titration dose. What we also learned from the CORAL study is that when we do our titration, as we've done in all of our programs to date, we see that most of the adverse events that we see typical for this compound, which are mostly GI and CNS in nature, most of those come on with the initiation of dosing. So what we're going to do is extend a little bit further the once a night dosing under the twenty-seven milligram dose, go into twenty-seven milligrams BID, and then get our fifty-four milligram BID treatment dose. So we will extend that titration period a little bit. To mitigate some of the earlier side effects that we see with the compound. And just a reminder about the adverse events that we see with Nalbuphine. Is that we typically see some GI and some CNS. These are typically transient and these are typically things that do tolerate out over time. And that's why we're going to extend that titration period. In regards to your question about allowing background antifibrotics, over eighty percent of our subjects in the CORAL study were on either nintedanib or pirfenidone. So yes, we are going to allow approved anti-fibrotic as background medication. In terms of biomarkers, we don't have any intention of looking at those in any, well, we're not going to look at those. And in terms of the sites, if you recall in CORAL, we were running that study ex-U.S. We will be going back to the more successful sites in that region. And we will also be bringing in a large number of U.S. centers. The great thing about the Pulmonary Fibrosis Foundation is that there are over 80 excellent care centers. And we are talking to them about conducting our trial. So we will be bringing in, in a major way, U.S. centers as well as Canada and Europe. William Wood: Got it. That's very helpful. Thank you for answering all my questions. Very briefly and lastly, the end of Phase II package, once you actually get that submitted and discussed, will you be relaying that to us and or investors, the public? Or is that just how will that be dispersed, I guess? Jennifer L. Good: Yeah. No, it's a good question, William. I think typically you do the meeting and then you wait thirty days for the minutes. Usually, you want to wait to see the minutes so that what we think we heard we actually see in writing when we get it. When we have that information, we'll definitely give an update to the Street. I mean, we probably won't put out a separate press release. I think one of our earnings calls or some venue, we'll use it to update people. But yeah, it's important information for sure. William Wood: Got it. Helpful. Thank you very much, and I'll hop back in the queue. Jennifer L. Good: Okay. Thanks, William. Operator: The next question comes from Kaveri Pohlman with Clear Street. Please go ahead. Kaveri Pohlman: Hi. Good evening. Thanks for taking my questions. So my first question is about how well do the current trial match the real-world patients, things like, you know, the inclusion exclusion criteria? Comorbidities, or, you know, use of other drugs. And for future trials, for both IPF and RCC, do you plan to make the eligibility criteria broader to include a more diverse population, or will they stay the same? James V. Cassella: Yeah, hi, this is Jim. So we will keep this population for the Phase III as broad as possible. We are really trying not to make it strictly a clinical trial population, but we want to keep it broad. So we are working with the KOLs to really refine our inclusion and exclusion criteria to make it definitely more real-world. So we will have few restrictions other than they need to be diagnosed with IPF, they need to have some other things that make them relatively healthy that they can actually be involved in the study. So I can promise you that it will be as broad as possible, as real life as possible. Jennifer L. Good: Not too much different than our 2b, right? James V. Cassella: Not very much different, in fact, somewhere else. Actually refining a few things to broaden it from our 2b. We will allow basically unless something that is going to interfere with our ability to measure cough or will have a direct impact on cough in the trial. Their concomitant medications will be allowed per normal. And I don't know if there's any, what else did you, was there anything else that you asked? Kaveri Pohlman: I think I covered those two things. Okay. Right. Yeah. That's helpful. And, I also want to understand for the RCC Phase 2b trial, do you plan to study the same dose regimen as it was in the Phase 2a or do you plan to kind of test QD options also since the drug seems pretty safe? James V. Cassella: Yeah. We're actually going to probably eliminate the top one hundred eight dose in that trial. And we will be exploring QD dosing, once a day dosing in that trial as well. Kaveri Pohlman: As well as BID. James V. Cassella: As well as the BID. So we'll probably add a 27 QD arm in there, because if you recall, the data, our twenty-seven BID dose was about as effective as the two higher doses. Kaveri Pohlman: Got it. And maybe just like a last one. Respiratory safety study, it was surprising that the FDA needed that after you showed 200 patients worth of data. But I still want to understand, will you be assessing long-term effects? Do you need to keep patients on to provide that data or it's not required? James V. Cassella: So I think the FDA is curious about doing a very specific study. I've been in this situation before where they like to see a more directed controlled study just rather than collecting adverse events. So I think it's their progress to ask for a study like this, I think it's going well. I'm sorry, what was the second part of it? Long term. I mean long term or long We will do long-term data collection in our Phase III program. The anticipation based on previous FDA experience here is they'll be looking for something like fifty-two weeks of safety data. Kaveri Pohlman: Got it. Alright. Thank you. Jennifer L. Good: Thanks, Kaveri. Operator: I'm not showing any further questions. This concludes our question and answer session. I would like to turn the call back over to Jennifer Good for closing remarks. Jennifer L. Good: Thank you. We appreciate you joining us for today's call. I know this is the end of earnings season, so you're all probably happy as well. Enjoy the upcoming holidays and we are available after the call or tomorrow for any follow-up questions that you may have. Thank you. Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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HYPR 2025 Q3 财报电话会议

Operator: Good afternoon, and welcome to Hyperfine, Inc.'s Third Quarter 2025 Earnings Conference Call. Currently, all participants are in a listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Webb Campbell from Jill Martin Group for introductory disclosure. Webb Campbell: Thank you for joining today's call. Earlier today, Hyperfine, Inc. released financial results for the quarter ended September 30, 2025. A copy of the press release is available on the company's website as well as sec.gov. Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained on this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including, without limitation, those related to our operating trends and future financial performance, expense management, expectations for hiring, training and adoption, growth in our organization, market opportunity, commercial and international expansion, regulatory approvals, and product development, are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by the forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our latest periodic filings with the Securities and Exchange Commission. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 13, 2025. Hyperfine, Inc. disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. With that, I will turn the call over to Maria Sainz, President and Chief Executive Officer. Maria Sainz: Good afternoon, and thank you for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Brett Hale. The third quarter marked an important new beginning for our business, driven by the launches of our next-generation subsystem and the Optive AI software. We delivered revenue of $3.4 million, up 27% sequentially, and materially expanded gross margins to a record of nearly 54%, supported by a record average selling price of $361,000. We also drove a meaningful reduction in cash burn, down 27% sequentially, excluding financing. And in October, we strengthened our balance sheet by raising over $20 million to extend our cash runway into 2027. We have discussed 2025 as a year of transformation and a tale of two halves, with the second half of the year's performance driven by the growth catalyst that came to fruition over the last few months, namely the new technology launches as well as the full launch into the new office market. I am pleased to report that after the first hundred days with our next-generation subsystem and the Optive AI software in the market, we have user feedback and proof points to feel confident our technology is now ready for mainstream adoption across the hospital, office, and international markets. In addition, we also have capital to support our commercial rollout for the foreseeable future. The third quarter is just the beginning of the next exciting chapter for Hyperfine as we meaningfully accelerate growth, drive commercial adoption, gain operational leverage, and improve our financial performance. Market interest and demand for our next-generation system is very strong. In the third quarter, we focused on deal activation and executed a seamless commercial launch, selling multiple units and building our sales funnel. Taking a step back, our journey to date has been driven by continuous innovation and iteration to deliver portable AI-powered MRI technology ready for mainstream adoption and scale. We launched the first-generation portable brain MRI system in 2020 with a very compelling clinical promise. The 64 millitesla mass net strength allowed for safe scanning anywhere, and the system was portable. The original image quality was in its infancy. Over the last five years, we have greatly improved image quality, incorporated AI, and have listened to our users closely to deliver a next-generation system that is ready for broad adoption. The next-generation system operates on the Optive AI software, which is our tenth-generation AI-powered software. In addition to a step-function improvement in image quality, additional upgrades include a user and patient-centric design to accommodate a broad patient population, especially beneficial for pediatric, elderly, or anxious patients, making MRI more accessible for all. Early users appreciate this system's high level of image quality, functionality, and usability. Many users have commented on how closely our Optive AI image quality resembles that of high-field scanners. Moreover, our office clinical study enrolled in the last few months will give us a robust dataset of comparative cases between the subsystem and high field, which I will discuss later in this call. The proprietary hardware in the new scanner enables us to drive image quality innovation through software updates going forward at a cadence of one to two releases per year. We are planning our first upgrade to the Optive AI software to be released in 2026. I am very proud of the AI expertise and leadership we have built at Hyperfine. We continue to be featured prominently on the AI-enabled medical devices list published by the FDA amongst the largest players in healthcare. Observing clinicians note that the images produced by our next-generation system with Optive AI approach those of conventional 1.5 Tesla MRI scanners, which is a testament to the impressive technical lead Hyperfine has developed in ultra-low field MRI. The radiology community is key to the adoption of our subsystem. This community has provided overwhelmingly positive feedback on our current image quality and is now broadly supportive. This new subsystem paired with Optive AI has triggered an activation of commercial deals markedly different than what we have seen in the past, with interest from multiple sites of care inside hospitals down to the most remote community health setting. I will now provide an update on our three diversified commercial verticals: the hospital, the office, and our international markets. Starting with our progress in the US hospital setting, we have placed our new system in all the hospital sites of care we call upon today, including adult critical care, pediatric critical care, and the emergency department. The device MSRP of our new subsystem is $550,000, roughly a 15% premium to the prior version. And these next-generation subsystem hospital placements resulted in a significant average selling price uplift in the third quarter. We have also converted our entire hospital deal pipeline to the next-generation subsystem. Compelling clinical utility, strong economic value proposition, multiple sites of care placement, and broad health system and IDN engagement are key long-term drivers to our hospital strategy. The clinical interest for the subsystem in ICUs, ERs, ORs, and clinics continues to increase to address the very real issues related to timely access to MRI and patient progress. The economic value proposition associated with the adoption of the subsystem, reducing cost, accelerating patient progress, and freeing up conventional MRI scanners for additional elective procedures, is compelling to administrators. Hospitals' return on investment assessments are showing one to one and a half year breakeven timeline versus three to four years typical for capital equipment. Although the subsystem is a capital acquisition process in the hospital setting, with strong radiology support, clinical interest, and administrative buy-in, we are now seeing higher priority placed on subsystem projects and acceleration of the deals in our pipeline. Our ability to go deep in the hospital and broad through health systems and integrated delivery networks is beginning to materialize. I am happy to share that in the third quarter, we sold two subsystems into the same hospital network, and our pipeline of multiple deals by hospitals is robust. Today, we are actively engaged with several health systems and IDNs to evaluate system-wide deals to standardize care. Generating evidence to further clinical relevance continues to be an important investment for us. Our work in stroke triage supports expansion into the emergency room, with the value proposition of the subsystem being strong given the importance of time to scan and the focus on patient progress in the ER setting. Our most recent effort, the PRIME study, being led by the Yale School of Medicine, evaluates the potential of AI-powered portable MRI technology to triage a broad, diversified set of patients who present to the emergency department. Enrollment in PRIME is going well, with over 75 patients enrolled. We have also begun evaluating the use of the subsystem in the Operating Room for neurosurgery, which represents a potential additional use case and expansion of our total addressable market. We recently commenced PRISM PMR, a study designed to collect data and optimize the subsystem's real-world clinical utility in this setting. We have enrolled over 20 cases at this point. Now turning to the office. In the third quarter, we commenced our full commercial launch of the subsystem into the neurology office setting. A completed pilot program in which multiple sites secured IAC accreditation, scanned patients, and received payment through the reimbursement process with CNS and private payers validated this opportunity. As I have previously mentioned, neurology offices represent a very compelling opportunity for the subsystem. Neurologists directly impact 100 million patient lives in the United States and order an average of 500 to 600 MRIs annually. But only approximately 10% of private neurology practices have MRI equipment on-site. The neurology office call point is large and diversified, with practices of many sizes based on the number of practitioners and volume of patients. We are proceeding with selling both the first model subsystem with Optive AI and the next-generation subsystem with Optive AI to provide more pricing flexibility in this setting. To drive the adoption in the office, similar to our strategy in the hospital, we have several clinical studies underway. Our most recent study, Neuro PMR, is run in the neurology offices to compare portable ultra-low field MRI and conventional 1.5 and 3 Tesla high-field MRI with respect to pathology findings, clinical utility, and patient experience. I am happy to share that the study has completed enrollment, and data is expected in early 2026. Additionally, our Alzheimer's study, Care PMR, continues enrollment with ongoing presentations of the increasing dataset at major medical conferences, most recently at AAIC 2025. Our team has been actively selling into both single and multiple clinician practices, building relationships and pipelines of both first and next-generation subsystems as we deploy a strategic segmentation pricing strategy to engage offices of all sizes. Additionally, we have been leveraging our partnership with NeuroNet to promote the subsystem to their network of neurology practices. Our full commercial launch in the office is still in its early days, and I have high optimism for this business vertical and its growth potential. Finally, turning toward international markets, where we are focused on selling primarily into the hospital setting. During the third quarter, we received CE Mark and UK CA Mark approvals for Optive AI software, and we now expect to launch Optive AI in 10 different European languages by the end of the year. We also expect our next-generation subsystem to be available in Europe and Canada markets by 2026. In the past few weeks, the subsystem was referenced in France's largest public hospital procurement body to facilitate nationwide purchases of portable MRI technology. Our international strategy includes our goal to launch in India, where we continue to anticipate regulatory approval before the end of this year. Looking ahead, we are driving three pipelines, one for each of our business verticals. The aggregate Hyperfine pipeline is stronger and more diversified than it has ever been. In conclusion, I am more optimistic than ever about the path ahead for Hyperfine. We now have a system that is ready for mainstream adoption and a diversified set of revenue-generating opportunities as we sell into hospitals, offices, and international markets. With this offering, we will be driving significant growth and financial performance improvement going forward. With that, I will now turn over the call to Brett to review our financial performance and 2025 guidance. Brett Hale: Thank you, Maria. I will recap our financial results for 2025 before providing an update on our financial guidance. Revenue for 2025 was $3.4 million, up 27% sequentially. In 2025, we sold eight units, had a strong mix of next-generation subsystem sales, and delivered a record average selling price. Gross profit for 2025 was $1.8 million, and gross margin for 2025 was 53.8%, a record and representing a 450 basis point increase sequentially driven by the increased average selling price. We continue to drive healthy margins for our stage and believe we are well-positioned for meaningful margin expansion at scale. R&D expenses for 2025 were $4 million, a sequential quarterly decrease from $4.5 million in the previous quarter. We continue to realize the benefits of the reorganization completed in the first quarter as we transition to a commercial growth stage organization. Sales, general, and administrative expenses for 2025 were $6.7 million, as compared to $6.4 million in the previous quarter. Net loss for 2025 was $11 million, equating to a net loss of $0.14 per share, as compared to a net loss of $9.2 million or a net loss of $0.12 per share in the prior sequential quarter. The third quarter 2025 net loss and the second quarter 2025 net loss included a non-cash change in fair value of warrant liabilities of $2.3 million and $0, respectively. For 2025, our net cash burn excluding financing was $5.9 million, down 27% sequentially from the prior quarter. Reducing our cash burn remains a significant focus of ours, and we will continue to prioritize spending discipline and optimize our operating leverage while also balancing the needs of our ongoing commercial launch and associated growth trajectory in 2025 and beyond. Our net cash burn including financing in 2025 was $3.9 million, and as of September 30, 2025, we have $21.6 million in cash and cash equivalents on our balance sheets. This cash balance does not include the $18.4 million in net proceeds raised from our October 16 equity financing and subsequent greenshoe that totaled $20.1 million in gross proceeds. We are in a strong capital position to continue fueling our commercial efforts. Now turning to our financial guidance. We expect revenue in 2025 to be approximately $5 to $6 million. This guidance range equates to a very significant revenue step-up and at the midpoint represents sequential and year-over-year quarterly growth of 60% and 137%, respectively. Accordingly, for the full year 2025, we now expect revenue to be $30 million to $40 million. For the full year 2025, we are now increasing our gross margin range to 49% to 51%, representing a 430 basis point increase in gross margin on a year-over-year basis at the midpoint. We expect the progression of gross margin percentage increase to closely follow our sales growth. We expect gross margins to exceed 50% going forward as we realize higher volumes and average selling prices driven by the execution upon our growth catalyst. Lastly, we now expect total cash burn to be in the range of $29 million to $31 million for the full year 2025, representing a 22% decline in cash burn on a year-over-year basis at the midpoint. We continue to operate lean, with strong spending discipline while making investments in areas such as inventory and commercialization to support our recent launches and capitalize on our strong commercial growth prospects. With our strengthened capital position, we now see our cash runway for the business lasting into 2027. I would now like to turn the call back to Maria for closing comments. Maria Sainz: Thank you, Brett. I am very proud of the Hyperfine team and the excellent work done to bring to market the Optive AI software and the next-generation subsystem. Medical technology businesses that build new markets often go through this transition from a first-generation pioneering technology to a next-gen ready for broad adoption. That is the transition we are undergoing at Hyperfine. The fundamentals remain strong, with broad labeling and existing reimbursement. Our strategy to diversify into multiple sites of care inside and outside the hospital and expand internationally is beginning to yield results. In addition, we now have capital to support our commercial growth for the foreseeable future. Q3 is just the beginning of the next exciting chapter for Hyperfine. With that, we now open the line for questions. Operator: Thank you. You will need to press star then the number one on your telephone keypad. And if you would like to withdraw your question, press star 1 again. We do request for today's session that you please limit to one question and one follow-up. Your first question comes from the line of Frank Takkinen with Lake Street Capital Markets. Your line is open. Frank Takkinen: Great. Thank you for taking the questions, and congrats on the progress. I was hoping to talk a little bit more about the composition of the backlog, maybe by setting would help as you are entering some new settings, maybe where have you seen backlog growth? And then as a second part to that question, just maybe talk about what is really supporting the $5 million to $6 million fourth quarter guidance. Is that record backlog? Is that faster conversion from order to actual shipment and revenue recognition? Any kind of context around that to support the guide would be helpful. Thanks. Maria Sainz: Sure. Hi, Frank. So, our pipeline, I think, it has evolved now with the full launch in the office business to be really three pipelines that we are really managing independently, and I would argue that we have the eyes of our sales leaders, but also our strategy leaders by business vertical, very, very intently involved in it. So we are managing a pipeline only associated with US hospital deals, another on US office deals, and the third one, which is our international business. So when you really add those three layers, the total continues to be an incredibly robust pipeline that is growing significantly from anything we have seen in previous quarters before we had again the new technology on the one hand but definitely the office business. The $5 to $6 million is predicated on what we are seeing in the pipeline, exactly the deals that are there. We do not comment on intra quarters. Sort of numbers. But I would say we are not only seeing more rows in the pipeline, but we are seeing more rows that have more than one unit. For some of the accounts that are looking to purchase this quarter and more going deeper into some of the IDNs with going from the first hospital in an IDN to a second hospital in the IDN. We are also managing the pipeline by individual, fed territory or sales area. So we are also very triangulating to make sure that we have confidence that we are not putting sort of all of the eggs in the one basket or one area, and we have a very nicely diversified across geographies and across the three verticals. Brett Hale: Yeah. I would add. This is Brett. I would add that the fourth quarter is the second quarter of the launch for both the next-generation technology in the hospital as well as in the office setting. So we, I think, commented previously that the first quarter was that first hundred days, and now we are into that, really, that second quarter where we converted the entire pipeline of hospital deals to next-generation technology in Q3. And we are seeing those that well, they are working through the process, and we anticipate, you know, them landing, you know, a subset of them landing here in Q4. So just kind of the natural order of the launch trajectory. Both with the next-generation technology as well as the office setting. Frank Takkinen: Got it. Really helpful. Thank you. And then maybe if I could try for 2026, I realize you are only talking about 2025 today, but any directional comments you can speak to on 2026 as we have a confluence of different growth drivers coming together at one. Maria Sainz: Appreciate the question, but I am going to tell you we are not really going to provide a lot of direction around 2026, a little bit because as Brett just mentioned, we are on quarter two of the launch. And a lot of what we are going to use, really, I like to think of Q3 as an incredibly important quarter where the first quarter showed sort of the excitement and the feedback on the actual technology and the beginning of that activation. This is the second quarter. A lot of it is going to be the launch pad into 2026. So we really would prefer to reserve the commentary around 2026 until we get into the beginning of 2026 with a closed Q4 as well. Again, it will continue to be composed of the things that I just outlined, so it is the three pipelines and it is clearly, time is always a friend because more things get added into the pipeline, and the hospital deals, as we know, sometimes take time. So, but for now, I think we are going to focus more on just what is near term Q4, 2025. Frank Takkinen: Okay. Fair enough. Thank you. Operator: Sure. Maria Sainz: Thank you. Operator: Your next question comes from the line of Yuan Zhi with B. Riley Securities. Your line is open. Hi. This is Paula on for Yuan. Thank you for taking our questions and congratulations on the quarter. I have a couple of questions. First, can you provide an update on the timeline and initial trajectory of market penetration in the neurology office? And when can we see a ramp-up of orders? And the second is for international expansion. Does it take similar time or longer time to sign the contract versus those in the US? Based on your current experience, what do you think are the major bottlenecks for international expansion? Thank you. Brett Hale: Great. So I think the I'll just maybe repeat the question, make sure we've got that right is that you're speaking about the penetration and foremost, into the neurology office. And then the timeline on international deals. Did I get that correct? Maria Sainz: Yes. Operator: Okay. Maria Sainz: So great question. So in I think in neurology offices, we really have a very active pipeline. We have said I think the call point is very, very large. So thinking in terms of percentage penetration, it's a little bit more challenging because I think what is really, really important to understand is how the offices are really grouped between what I would call the more solo practitioners, a single practitioner versus multiple practitioners. That immediately dictates the size of the practice. And with the size of the practice, there's a very strong correlation to the volume of scans that they are going to do and how they think about the economics of being in technology like the subsystem to add on imaging to their offering. Right now, we have a bit of a segmentation approach where we are using our first model with the latest software with Optive AI at a price point that offers more flexibility to go into the smaller offices. And we are using, of course, our next generation with the same software, Optive AI, for the larger. We also have a partnership with NeuroNet, which de facto operates a little bit like an IDN, if you want, of the office space. To be able to penetrate that group. We're also going to be going for the first time to one of the meetings that groups those kinds of offices together, which is a headache meeting, which is happening early December in the US. So we're really trying to drive the strategy to go and approach both call points, but we haven't really and we're looking at growing on both. On the solo practices as well as on the multipractitioner, larger volume practice but I don't have a good metric of penetration. It will be more about the growth and the adoption. You remember maybe that we conducted a study called Neuro PMR. We conducted it in two very, very large practices. The Dent Institute in Buffalo and Texas Neurology in Dallas. We started in April, but we were able to put the new devices into those two practices for the study so that the data that comes out, which is now only literally a few a couple of months away because it will be early 2026, is with the latest technology, both hardware and software. So that's going to be really exciting. To your question about international, I said, international is not about the office. International is about hospitals. So there are some procurement processes. There are some tendering processes. There are some multidimensional processes like in the US. One of the big wins this quarter was the French referencing. So this body called UniHA, which is really a very large catalog procurement process that allows all French hospitals to more swiftly buy through that without a lot of the procurement process kind of timelines. So we think, for instance, in a market like France, we will start seeing a more expedited way of being able to transact with hospitals, but it is still hospitals. So it's not a swift decision-making as the, as the. And for international, it's really important that it really is going to be this quarter when we bring to them the new image quality. Although we did get the clearances both on the CE Mark front and the UK CA front last quarter. There's another work stream that we need to do beyond the regulatory approval, which is produce the software and all the labeling and the documentation in local languages. We now have 10 different local languages. So the Optive AI with the new level of image quality will get launched in local languages in 10 of those local languages. Only here in Q4. Paula: Okay. Okay. Thank you. Operator: Of course. Thank you. Maria Sainz: Thank you for your question. Operator: No further questions at this time. I would like to turn the call back over to Maria Sainz, CEO, for closing remarks. Maria Sainz: Thanks, everyone, for joining us in today's call. I'm truly, truly excited about the inflection point in which we are at our company, and I look forward to providing you further updates here in just a few short months. Thanks, everyone. Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

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RMR 2025 Q4 财报电话会议

Operator: Good morning, and welcome to The RMR Group Fiscal Fourth Quarter 2025 Earnings Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Bryan Maher, Senior Vice President. Please go ahead. Bryan Maher: Thank you, and good morning. Thank you for joining RMR's fiscal fourth quarter 2025 conference call. With me on today's call are President and CEO, Adam Portnoy; Chief Operating Officer, Matt Jordan; and Chief Financial Officer, Matt Brown. In just a moment, they will provide details about our business and quarterly results, followed by a question-and-answer session. I would also like to note that the recording and retransmission of today's conference call is prohibited without the prior written consent of the company. Today's conference call contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. These forward-looking statements are based on RMR's beliefs and expectations as of today, November 13, 2025, and actual results may differ materially from those that we project. The company undertakes no obligation to revise or publicly release the results of any revision to the forward-looking statements made in today's conference call. Additional information concerning factors that could cause those differences is contained in our filings with the Securities and Exchange Commission, which can be found on our website at rmrgroup.com. Investors are cautioned not to place undue reliance upon any forward-looking statements. In addition, we may discuss non-GAAP numbers during this call, including adjusted net income per share, distributable earnings and adjusted EBITDA. A reconciliation of net income determined in accordance with U.S. generally accepted accounting principles to these non-GAAP figures can be found in our financial results. I will now turn the call over to Adam. Adam Portnoy: Thanks, Bryan, and thank you all for joining us this morning. Yesterday, we reported fourth quarter results that were in line with our expectations, highlighted by distributable earnings of $0.44 per share, adjusted net income of $0.22 per share and adjusted EBITDA of $20.5 million. Despite a continued unsettled economic environment, RMR was active this past quarter executing on our clients' strategic initiatives. The majority of these activities took place in our managed equity REITs, where we completed nearly $2 billion of accretive debt financings at attractive rates and we completed over $300 million in asset sales. We believe these efforts are being recognized in the public markets, as demonstrated by the share price improvements at both DHC and ILPT. These share price improvements have resulted in DHC and ILPT both accruing potential incentive fees for RMR, which highlights the alignment of interest RMR has with the shareholders of our managed equity REITs. While subject to change, these potential incentive fees could be approximately $22 million in 2025. Turning to a few notable updates at our perpetual capital clients. DHC posted solid quarterly results led by strong sector tailwinds benefiting DHC's senior housing segment as well as the significant capital that has been invested in DHC's communities. Consolidated SHOP NOI increased 8% year-over-year to $29.6 million, led by a 210-basis point increase in occupancy to 81.5%, a 5.3% increase in average monthly rates. Beyond its continued focus on SHOP operations, DHC has also been executing on its strategic transformation. More specifically, DHC announced the successful sale of non-core assets at attractive valuations as it further deleverages its balance sheet. During the quarter, DHC also began executing on its announced transition of 116 SHOP communities from AlerisLife to new operators that have proven track records and well-established regional footprints. The transition of all 116 communities is expected to occur by year-end 2025. SVC continues to make significant progress selling non-core hotels to delever its balance sheet. During the quarter, SVC completed the sale of 40 hotels for over $292 million and is on pace to sell a total of 121 hotels in 2025 for $959 million. SVC also successfully completed a 0-coupon bond offering that raised $490 million in net proceeds that were used to repay SVC's revolving credit facility and retire the remainder of SVC's 2026 debt maturities. Beyond the deleveraging efforts, we remain focused on helping SVC drive EBITDA growth across its hotel portfolio, despite softening demand and ongoing revenue displacement from renovation activity. Further, our organization continues to keep SVC's triple net lease portfolio, which is anchored by the travel centers leased to investment-grade rated BP, well leased to ensure SVC benefits from the stable cash flows these assets generate. Seven Hills, our mortgage REIT, delivered another solid quarter, supported by a fully performing $642 million loan portfolio. Seven Hills has been exploring ways to generate new equity capital to ensure the REIT can continue to capitalize on the robust pipeline of investment opportunities our Tremont commercial lending team generates. To that end, Seven Hills recently announced a rights offering to raise approximately $65 million in new equity, which should allow for over $200 million in gross new loan investments. The rights offering is structured so that shareholders of record on November 10 were given a transferable right to buy 1 new share for every 2 shares they currently own. Importantly, RMR, which is Seven Hills largest shareholder, has agreed to backstop this offering, essentially acquiring any unexercised rights as a demonstration of our confidence in Seven Hills business prospects going forward. Lastly, in late October, OPI, after exploring all possible strategies to address its capital structure, entered into a restructuring support agreement, or RSA, with certain holders of its senior secured notes to restructure its corporate debt. As part of the RSA, OPI voluntarily initiated a court supervised process under Chapter 11 of the U.S. Bankruptcy Code. This agreement will meaningfully strengthen OPI's financial position and delever the balance sheet. As part of the RSA, RMR has agreed to continue managing OPI for a 5-year term that starts upon OPI's emergence from bankruptcy. RMR will receive a flat business management fee during the first 2 years of $14 million per year, and our property management agreement will remain unchanged. To support OPI's operations during this process, OPI entered into a debtor in possession financing of $125 million. We remain committed to supporting the assets, vendors and tenants of OPI throughout this process and look forward to updating you as new information becomes available in the future. To conclude, we are pleased with the progress RMR has made over the past quarter, assisting our public company clients with their financial and strategic objectives. Our perpetual capital clients also provide RMR with stable cash flows, which we can use to pursue new growth initiatives in the private capital space to drive future revenue and earnings growth. With that, I'll now turn the call over to Matt Jordan, Executive Vice President and Chief Operating Officer, to provide added insights on our platform and private capital growth initiatives. Matthew Jordan: Thanks, Adam, and good morning, everyone. As Adam mentioned, this past quarter was active on a number of fronts across the RMR platform. From a non-residential leasing perspective, despite continued headwinds, this past quarter, RMR arranged almost 1.4 million square feet of leases, and for the full fiscal year, almost 8 million square feet of leases at rental rates approximately 14% higher than previous rents for the same space. We believe these results speak to the hard work of our people, proactively engaging both tenants and the brokerage community. Beyond leasing, the platform continues to invest in our people, technology and brand building to ensure we stand out in a competitive fundraising environment. While fundraising remains challenging, we believe 2026 will be a better year for institutional investments in real estate, as recent conversations our capital formation team is having with potential partners have reinforced commitments to the United States in many of the sectors we operate in. Further, while many private capital investors are limiting how many new manager relationships they form given the effort associated with underwriting a new manager, the breadth and scale of our platform remains an attractive differentiator. Our current fundraising efforts remain focused on residential, credit and select development opportunities. Though as I noted, the diversity and scale of our platform will allow us to pivot quickly based on investor feedback. As it relates to RMR Residential, which currently manages almost $5 billion in value-add residential real estate, we formally launched fundraising for the enhanced growth venture in early September. Our efforts are focused on finding up to 3 large investors to invest approximately $250 million in multifamily real estate. This venture is targeting value-add returns and provides investors the ability to share in property level and general partner economics. RMR's commitment via almost $100 million in seed investments provides investors certainty that committed monies can be immediately put to work as well as providing them a portfolio they can readily underwrite. The seed investments include the 2 acquisitions closed this quarter for a gross aggregate cost of $143.4 million. One is a 266-unit property near Raleigh, North Carolina, and the other is a 275-unit property near Orlando, Florida. We expect there to be meaningful updates regarding the enhanced growth venture by early spring. Within the retail sector, we continue to source investment opportunities as we build a portfolio of value-add multi-tenant retail properties as part of establishing a track record in this sector. Our first investment, a $21 million community shopping center outside of Chicago, closed earlier this year and is executing on its underwritten business plan. We are currently assessing market opportunities with the goal of adding at least 2 more similarly sized deals. As it relates to our credit strategy, although we expect to close on the sale of 2 loans that are on our balance sheet later this month, we continue to explore opportunities to form a strategic venture with institutional capital. Real estate credit remains a high conviction strategy, and we believe Tremont's track record, middle market focus and strong underwriting and asset management teams are attractive differentiators. With that, I'll now turn the call over to Matt Brown, Executive Vice President and our Chief Financial Officer. Matthew Brown: Thanks, Matt, and good morning, everyone. As Adam highlighted, this quarter, we reported adjusted EBITDA of $20.5 million, distributable earnings of $0.44 per share and adjusted net income of $0.22 per share, all of which were in line with our expectations. Recurring service revenues were approximately $45.5 million, a sequential quarter increase of approximately $1.5 million, driven primarily by increases in enterprise values at DHC, ILPT and SVC and higher construction supervision fees. Next quarter, we expect recurring service revenues to decrease to approximately $42.5 million, driven by lost fee revenue from the announced sale of AlerisLife's business and decreases in certain of our managed REITs enterprise values from accretive debt financings and asset sales as we strategically manage their debt levels. Turning to expenses. Recurring cash compensation was $38.5 million this quarter, which was consistent with the prior quarter. Looking ahead to next quarter, we expect cash compensation to decline to approximately $37 million as recent cost containment measures continue to positively impact earnings. We expect our cash compensation reimbursement rate to be between 46% and 47% going forward. Recurring G&A this quarter was $10.1 million, a modest sequential quarter increase driven by costs associated with our ongoing private capital fundraising efforts. We expect recurring G&A to remain at these levels over the next couple of quarters. Interest expense this quarter increased to $1.7 million following the acquisitions of 2 leveraged residential properties that Matt highlighted. Interest expense next quarter is expected to increase to approximately $2.6 million as we incur a full quarter of interest on these new mortgages. It is also worth noting that this quarter's income tax rate of 21.4% reflects year-end adjustments primarily related to stock-based compensation. For modeling purposes, we expect our tax rate to decline to approximately 15% in Q1 based on our current forecast for incentive fees we may earn for calendar year 2025 and to approximately 18% for Q2 to Q4. As Matt mentioned on the call last quarter, we believe cash flow measures such as adjusted EBITDA and distributable earnings per share are becoming more relevant when comparing our results to prior periods and other alternative asset managers. Our private capital business is accretive to our cash flow, but as we continue to use RMR's strong balance sheet for strategic growth initiatives, expenses such as depreciation and interest will have an adverse impact on certain financial metrics, such as adjusted net income per share. Aggregating the collective assumptions I've outlined, next quarter, we expect adjusted EBITDA to be between $18 million to $20 million, distributable earnings to be between $0.42 and $0.44 per share and adjusted net income to be between $0.16 and $0.18 per share. This expected decline in quarterly results is mainly due to the sale of AlerisLife's business. For the fiscal fourth quarter and full year, we earned $1.4 million and $5.7 million, respectively, of fee revenue on the AlerisLife contract. We expect to offset this lost revenue with increases in DHC's enterprise value, as new operators that have well-established regional footprints and proven track records should help drive NOI growth. We ended the quarter with $162 million of total liquidity, including $62 million in cash and $100 million of capacity on our undrawn revolving credit facility. Finally, as Adam mentioned, if September 30 was the end of the measurement period, we would earn incentive fees from DHC and ILPT of approximately $22 million in the aggregate. That concludes our prepared remarks. Operator, please open the line for questions. Operator: [Operator Instructions] The first question comes from Mitch Germain with Citizens Bank. Mitch Germain: I'm curious about OPI's fee. Does it in effect go up quarter-over-quarter? Adam Portnoy: Mitch, I think your question -- you broke up for me -- is about OPI's fees. See, effectively, it's pretty much flat. We were earning just under $14 million a year on a business management basis. It was like $13 million and change over the last 12 months, give or take. And so we have a contract that we'll be earning $14 million fixed fee for the first 2 years per year, $14 million. On the property management agreement, nothing's changed. All the economics are the exact same as they were prior to the filing. During -- just to be very clear, during the pendency of the bankruptcy itself, we are operating under the existing contract. So we probably will earn a little bit less than a $14 million run rate during the pendency of the bankruptcy. But upon emergence from the bankruptcy, that's when the clock starts and that's when the $14 million per year goes into effect. I'll just say -- it might be a correlator to your question. Look, the fact that we entered into what we call a restructuring support agreement, we think leads to hopefully a much faster bankruptcy process and allows us to get out of bankruptcy, hopefully, faster than if we had not entered with an RSA. So it's a little unclear exactly when we'll emerge, but I think roughly speaking, it's first half of 2026 we'll emerge. Mitch Germain: Got you. I think, Adam, you mentioned where your focus is on the private capital side in terms of fundraising. Maybe I missed it, but I didn't hear you mention shopping centers as a competency that you're raising capital for. Yet you guys are -- obviously, you own one and you're looking to allocate capital to others. So maybe just kind of go over where that sits with regards to your private capital strategy. Adam Portnoy: Sure. Sure, Mitch. So it's a great question. Matt touched a little bit on this in his prepared remarks. But you're right, we have it on our balance sheet. We think we have a lot of core competency in retail. We run a very large multibillion-dollar existing retail portfolio. Today, we have a very large, very competent retail asset management team on staff. We -- it's not front and center, but already in parts of our organization, given the size and breadth of the different portfolios. We do actually run shopping centers in different parts of the business, let's say, buried within some other asset classes or buried within some of the portfolios. So we do have experience there. We think for a lot of reasons investing in neighborhood and grocery-anchored specifically shopping centers is a great thing to be doing right now. Retail has really gone through transformation over the last 10 to 15 years, and we really have a pretty good supply-demand dynamic going on, where there's not a lot of new supply, and demand has sort of finally caught up with the existing supply. And so we see a lot of interesting opportunities to basically put money to work. And through either capital improvements or re-tenanting a center, we can generate outsized returns. And we're doing that first on our balance sheet, but we're pretty confident that we're going to be successful with that and that we'll be able to then take that -- demonstrate that track record and raise more capital around that going forward. Matt, do you want to add anything to that? Matthew Jordan: No. And I think, Mitch, we have the one asset outside of Chicago. And the point we were making in the prepared remarks is we're hoping to at least add a couple more of similar sized scale to build a fulsome track record that we can go out and fundraise around in hopefully a couple of years from now. Mitch Germain: Got you. And then did I hear that you guys have a couple of additional loan investments that are under agreement? Did I mishear that? Adam Portnoy: We don't have new -- at RMR itself, we do not have any new loan investments. We are -- I don't think we discussed in our prepared remarks, but it is in our public disclosures. We are selling or have an agreement to sell the 2 loans that we have on our balance sheet. Those are being sold. There's currently no plan to put more loans on RMR's balance sheet. What I did mention in my prepared remarks is we have a rights offering that we're in the middle of occurring at Seven Hills. And we expect, as a result of that, we'll have about $65 million of equity, which provides for about $200 million in additional loan investments that we plan to deploy over the following, call it, 6 months to get that money out. If your average loan size is $25 million, that's, call it, 8 loans, 8 to 10 loans, give or take, that will be new loans that we will be putting money out at Seven Hills. Mitch Germain: Last one for me. Matt, maybe just kind of go through the puts and takes to get you to your forecast in the first quarter, maybe a bridge from where you ended the fiscal fourth quarter to how you get to the first quarter in terms of your guidance, please? Matthew Brown: Sure. I'll focus on adjusted EBITDA for that. So fiscal fourth quarter was $20.5 million. Our forecast for fiscal Q1 is $18 million to $20 million. The major impact of that is the sale of AlerisLife's business and the wind down of that. Today, we earn 60 basis points on the revenue of our senior living communities. And as that winds down, we're expecting revenues to decrease about $1 million for that alone. So that's the major headline from the decrease from fiscal Q4 to fiscal Q1. Operator: [Operator Instructions] The next question comes from John Massocca with B. Riley. John Massocca: Maybe just sticking with that question quickly. Is there any expected additional negative flow through from the loss of managing AlerisLife as we think beyond next quarter? Matthew Brown: So the full wind down should happen by the end of this year. So while we're expecting about $1 million decrease in fee revenue this coming quarter, we will -- we did earn $1.4 million in fiscal Q4. So there'll be another kind of $400,000 deduct when we roll forward to fiscal Q2. John Massocca: Okay. And then maybe moving on to OPI. Can you just walk through what the advisory agreement looks like after 2 years? If you're still managing that portfolio? Adam Portnoy: Sure. So it's a 5 -- it's a term sheet we entered into with the -- what will be likely the new equity owners of OPI upon emergence. It's a 5-year term. The first 2 years are set at $14 million per year in the business management fees. The property management stays unchanged. And during the first 2 years, if -- now that $14 million stays the same, whether the portfolio shrinks or grows. It doesn't matter what the size of the portfolio is, that sort of stays in place at $14 million per year. After 2 years, we -- there's a negotiation. And I think -- look, the reason it was set up that way is with the new owners of OPI, I think there's a little bit of a hesitancy about how to structure the fee in terms of what it should be based on because we're not quite sure exactly the size and the makeup of OPI, let's say, over the next couple of years. We're confident and I think the new investors or new owners of OPI are confident that we will still be managing it over the next 2 to 3 years. But as part of that, I think they just want to see how the next couple of years play out, what's the size of the company. It could shrink from the size it is today. It could also grow from the size it is today. I mean part of what we've had discussions with the new owners about is that this vehicle might be used -- and I'm not saying this will be used, I'm saying it might be used as a vehicle to roll up other distressed office portfolios in the marketplace. I mean we're pretty encouraged that we found a group of investors. They currently own the debt. They wanted to equitize their debt and really want to go long on office because they really see as a great opportunity, both from a macro perspective -- and I think they also feel pretty good about the portfolio itself. Meaning there's a lot of pain that the OPI portfolio has gone through, but the vast majority of that pain is behind us. Looking forward, it looks much better than what we've gone through over the last 2 or 3 years in terms of leasing prospects and cash flow or NOI that's going to be coming out from the property. The other thing I'll mention, in the term sheet that's on file and is public is it also contemplates a significant incentive fee to be structured for RMR as well. It's anticipated that upfront, we will be getting 2% of the reorganized company and then another 8% that's a little bit more ambiguous but will be benchmarked to sort of outperforming benchmarks. Basically, think about it as sort of structured like a classic promote that you might see in a private equity type investment. That's what I think the other 8% will be structured like. So I think there's going to also be a higher degree of alignment between the manager and the new equity owners in terms of performing -- doing a good job in managing the portfolio and generating a healthy return for those equity holders. John Massocca: Okay. Kind of longer-term question given -- you have the 2-year contract, locked-in contract in place. But how kind of flexible is G&A spending to managing OPI? I guess, how much could you potentially bring down G&A if for whatever reason at the end of 2 years post emerging from bankruptcy, the portfolio goes in a different direction or the owners want to go a different way? Like is there kind of a high amount of leverage into how you can kind of pull down G&A if you're not managing OPI here in a couple of years? Adam Portnoy: The short answer is, we spend a lot of time thinking about that. As you know, John, we don't have P&Ls by business line, right? That's one of the advantages of the economies of scale for our clients that they basically manage with RMR. And we get those economies because we get the spread costs across the entire structure. So we don't have P&Ls, let's say, by business line or client. But I can tell you this much, office as an asset class is probably the most management-intensive asset class that we manage at RMR. And so while I don't believe this will be the case, if we were to not be managing, let's say, a large office portfolio at the company, I do think there would be significant cost cuts that we could take. I don't believe to even go even further. We're not quite sure what would happen to margins, but there's a scenario where we might have less cash flow but higher margins, if you can follow me, because we just know intuitively there's a lot of people that work on the office portfolio versus other portfolios we run. So I think we would be able to -- in the unlike -- what I believe is unlikely situation where we are no longer managing a large office portfolio, I think we would be able to correspondingly reduce costs at the organization. John Massocca: You touched on it a little bit with Mitch's question, but thinking about kind of the Seven Hills and selling kind of the loans that were on RMR's balance sheet to Seven Hills, what was kind of the logic there? Maybe I'm misremembering past calls, but it felt like there might have been an opportunity to grow the loan book within -- on the RMR balance sheet. Is there some kind of change strategically where you're no longer seeing that as attractive? Just kind of curious the thought process behind that transaction. Matthew Jordan: Yes, John, it's Matt. So if we go back in time about a year ago when we put these loans on our balance sheet, the goal was for them to be part of a seed portfolio to help us with the fundraising process. And they've been well-performing, incredibly strong loans that have contributed to RMR's earnings, quite frankly, in a significant way. But it's now been 12 to 18 months since those loans were initiated. And as we fund raise in a very competitive environment, I think it's fair to say -- one of the loans actually matures next July, I believe. So their attractiveness from a seed perspective had fallen off. And at the same time, you have Seven Hills that's raising this significant money. We want to make sure they can quickly deploy those proceeds. And by selling these loans at par to Seven Hills, it allows them to start quickly deploying, secure their dividend, which is also critical to this rights offering. And it just was a successful transaction for both sides. John Massocca: Okay. With Seven Hills in mind, any updates you can provide on how the rights offering is looking at this moment? I know it's -- obviously, there's moving pieces and things you might not be able to talk about. But just was kind of curious if there was any outlook on the amount of the rights offering you expect RMR to participate in. Adam Portnoy: Sure, John. So you mentioned it is sort of early. And the way these rights –- the way rights offerings typically work, not just this company, but the way they always do is, unfortunately, you really don't -- everyone sort of waits till the last minute, which you have to keep the rights out -- you have to have the -- about a month outstanding before people have a deadline to exercise the right. And so for whatever reason -- and I guess it's people like to keep their options open till the very last minute. You just don't know till the very end how many people are going to be exercising their rights. What I can tell you is that as part of the rights offering, we retained UBS Investment Bank as the dealer manager. And part of their job -- and one of their jobs is to basically solicit interest from outside investors that might want to buy the rights that other shareholders want to sell, meaning shareholders that don't want to exercise. And while there's been very little trading, it's only been a few days in the rights themselves. What has been encouraging is that we have had quite a bit of interactions with share -- new shareholders that are interested in perhaps buying rights from other shareholders that don't want to exercise them. Existing shareholders decide they don't want to exercise them, so they want to sell them. And we are working with UBS to try to help identify potential buyers of those. And what I'm saying is it's too early to tell, but we're having lots of meetings, right? And so there is interest out there. To get to the heart of your question, which is, well, how much is RMR going to have to spend here, or do we have to spend any? I think our base case assumption is that we don't expect that we're going to have to drop -- basically pull on the backstop beyond our 11% ownership. Meaning we own 11% today. We expect to exercise up to that 11%. It could be that we end up exercising some amount. I think it would be less than, let's say, half, if I had to guess. And so there's a possibility somewhere between 11% and 50% of the offering itself we might have to backstop. But again, it's very early. I mean, I do not believe it would be more than half the offering. I think that's pretty -- I don't want to say locked in stone, but it's hard to imagine that scenario. And I think it's -- our base case is that we will just be exercised -- just exercising up to the 11%. Could we end up exercising a little bit over that to fill out the backstop? Yes. But it's very hard to know for sure where the numbers are going to shake out. Operator: We now have a follow-up from Mitch Germain with Citizens Bank. Mitch Germain: Just quickly on the -- I know that, Matt, you talked about a bit of a true-up on interest expense because you've got a -- had it in place for a sub-quarter. Do we have a similar true-up for the -- what's the true-up for the rental income associated with the 2 residential assets that were acquired mid-quarter? How should we think about that? Matthew Brown: Yes. I think the best way to think about our wholly-owned portfolio, which includes the 2 residential acquisitions from the quarter, is we're expecting about $3.2 million of NOI to be contributed on a quarterly basis for those while they remain on the balance sheet. Mitch Germain: So that's aligned with this quarter. Is that the way to think about it? I think we're at $3.2 million right now. Matthew Brown: The owned real estate contributed about $650,000 of EBITDA in Q4. So that will grow to just over $3 million on a run rate basis. Mitch Germain: Okay. And then how should we think about -- you guys are pretty flushed with cash, but obviously, with the rights offering and some acquisitions that you're making. So how should we think about that balance on a go-forward basis? Adam Portnoy: So you're right to point out the rights offering. I think it's hard for us to put a stake in the ground to say exactly where we think things will be. As we sit today, we don't believe based on all the actions we have underway that we will be drawing on the revolver. That's not something we think. But it could be that we use more cash, obviously, than we have on the balance sheet today. We will be getting proceeds from the sale of the loans themselves. There will be a liquidity event, we hope and think, as we get into 2026 as we sell the enhanced growth fund. What? Matthew Brown: Plus incentive fees. Adam Portnoy: Plus incentive fees that we'll be getting, hopefully, at the end of the year. So we don't think we'll be drawing on the revolver, if that's maybe the question. It's hard to know exactly where the cash balance will be. I will say that we're not -- we don't feel cash constrained. We're still very active in terms of all of our initiatives in terms of continuing to look at other retail properties. We continue to look at sort of JV investments, GP investments on the residential side. So I think we feel that we're not constrained in our ability to continue to do things. But we are waiting to see where the rights offering shakes out and whether incentive fees actually shake out for the year. Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Adam Portnoy, President and Chief Executive Officer, for any closing remarks. Adam Portnoy: Thank you all for joining our call today. Institutional investors should contact RMR Investor Relations if you would like to schedule a meeting with management. Operator, that concludes our call. Operator: The conference has now concluded. Thank you for attending today's presentation, and you may now disconnect.

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TLSI 2025 Q3 财报电话会议

Operator: Good afternoon, and welcome to TriSalus Life Sciences' Third Quarter 2025 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded for replay purposes. I will now turn the call over to Jeremy Feffer, Managing Director with LifeSci Advisors. Please go ahead, sir. Jeremy Feffer: Thank you, operator, and thank you all for participating in today's call. Joining me today from TriSalus Life Sciences are Mary Szela, President and Chief Executive Officer; David Patience, Chief Financial Officer; and Dr. Richard Marshall, Medical Director. Ms. Szela will provide an overview of the company's third quarter results and strategy for the balance of the year. Then Mr. Patience will review the financial results for the quarter in detail. Following their prepared remarks, Dr. Marshall will join the call to help address questions from covering analysts. Earlier this afternoon, TriSalus released its financial results for the quarter ended September 30, 2025. A copy of this press release is available on TriSalus' website. Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Reform Act of 1995. Any statements contained in this call other than the statements of historical fact are forward-looking statements. All forward-looking statements, including, without limitation, statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations and future product development and approvals are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties, including the impact of macroeconomic conditions and global events that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 10-Q on file with the SEC and available on EDGAR and our other reports filed periodically with the SEC. TriSalus disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. The conference call contains time-sensitive information and is accurate only as of this live broadcast today, November 13, 2025. And with that, I'll turn the call over to Mary. Mary Szela: Thank you, Jeremy, and good afternoon, everyone. Thank you for joining us for a review of our third quarter 2025 results. I will begin with a high-level review of the quarter and recent weeks and provide a quick update of our longer-term strategy. David will then follow my remarks to provide a more in-depth review of our financial and operational results for the quarter. We will then be happy to open the call to questions. Let's begin. I'm pleased to report that our third quarter results were strong. Revenues were $11.6 million, representing 57% increase over the prior year quarter and a 3% sequential gain over the second quarter of 2025. During the quarter, we also continued to expand our TriNav platform, launching our TriNav FLX infusion system and advancing new clinical applications to expand our market opportunities. We also simplified our capital structure through the successful completion of our exchange offer and consent solicitation for preferred stock. Operationally, we continue to manage cash efficiently, ensuring resources were allocated strategically to advance our key priorities. We increased commercial investment to maintain our strong growth, a deliberate decision that extends our time line to reach EBITDA positive and cash flow breakeven. Our commercial momentum in the third quarter remained strong. The commercial organization continued to drive deeper penetration within the complex liver embolization market. Bolstered by the Centers for Medicare and Medicaid Services, CMS, HCPCS code C8004 introduced in April. This new code expands coverage to include simulation angiogram or mapping procedures using TriNav, enabling interventional radiologists to utilize TriNav for other treatment planning and delivery using radioembolization. As a result, the reimbursable use of our technology within the radioembolization market has effectively doubled, supporting the broader adoption we're observing. Now interventional radiologists are able to use TriNav across the full continuum of radioembolization care. Early feedback from key accounts and users highlight the clinical and economic advantages of the expanded reimbursement, which we expect to continue driving adoption into 2026. We are reaffirming our 50% revenue growth guidance, reflecting strong confidence in our growth momentum and market opportunities. Consistent with our prior commitment, we continue to invest in long-term growth via increasing commercial resources and funding of new applications. We believe TriSalus' Pressure-Enabled Drug Delivery, or PEDD technology represents a transformative opportunity with substantial long-term value across a wide range of solid tumors and interventional treatment approaches. We continue to execute a focused strategy to expand our platform with technologies that address the complex challenges of tumor vasculature and improved delivery. Momentum across our programs remain strong, reflecting the growing clinical and commercial impact of our PEDD technology. In the last year, we launched TriNav LV, TriGuide and the TriNav FLX, each advancing our commitment to innovation and improving therapeutic delivery precision. Expanding our product suite broadens our addressable market, strengthens physician adoption due to a technological solution for all the various vascular challenges and extends our reach beyond the liver into new therapeutic areas. Expanding our product portfolio remains a core pillar of our growth strategy. By broadening our addressable market and delivering solutions with greater versatility and precision, we're enabling more physicians to treat complex patients and extending our reach beyond the liver into new therapeutic areas. Following the quarter, we began market evaluation of our next-generation TriNav XP, which features compatibility with larger particles and a more flexible distal tip, an important advancement for low bar liver and uterine artery embolization procedures. Although early, feedback from over 20 initial cases with key opinion leaders have been outstanding, which highlighted exceptional trackability, enhanced visualization for precise targeting and improved professional efficiency. These advances reinforce our confidence in TriNav powered by PEDD, as a platform that helps interventional radiologists address their most difficult tumor drug delivery challenges, we continue to invest in the TriNav portfolio to deepen its clinical impact to improve drug penetration, reduce complications and expand patient eligibility. Our results this quarter demonstrate that TriNav is well positioned to become the standard of care in liver embolization for complex patients. We remain focused on strengthening the clinical evidence base, engaging closely with key medical societies and driving commercial expansion to fully realize TriNav's market potential. As previously discussed, beyond leveraging our PEDD technology in liver cancer, we're also expanding the clinical application through the TriNav Infusion System. Yesterday, we hosted the first in a series of key opinion leader events focused on the potential use of TriNav Infusion for the treatment of uterine fibroids. The event featured Dr. Nicole Lamparello of Weill Cornell Medicine and NewYork-Presbyterian Hospital and Dr. Francis King of Rutgers Robert Wood Johnson University Hospital and University Radiology Group. Both speakers highlighted the significant unmet need in uterine fibroid treatment and reviewed the current therapeutic landscape. In addition, enrollment continues in our PROTECT registry, a multicenter initiative evaluating PEDD for patients with thyroid nodules or goiters who are not candidate for surgery radioiodine or ablation. This study is designed to assess disease-related quality of life, thyroid function and outcomes following PEDD-based thyroid artery embolization. As previously noted, preliminary results published in the Journal of Endocrine Society were highly encouraging, showing 100% technical and clinical success, no neurovascular complications, mild and transient discomfort in 81 of all patients, all resolved within 2 weeks and a 73% reduction in thyroid size and importantly, normalization of thyroid function in 71% of participants. These findings reinforce the promise of this minimally invasive alternative to thyroidectomy. We also initiated a pilot registry in the emerging field of genicular artery embolization or called GAE, which offers a novel minimally invasive approach to pain management and mobility preservation for patients with knee osteoarthritis. GAE has the potential to delay or avoid total knee arthroplasty in select patients. In parallel, we're preparing to launch a clinical trial evaluating TriNav and GAE as a treatment option for knee osteoarthritis, a condition affecting more than 30 million adults in the United States. The study aims to determine whether TriNav and GAE can effectively reduce pain and delay the need for knee replacement surgery. In parallel with expanding the clinical utility of TriNav, we're also advancing our efforts to begin partnership discussions to maximize the long-term value of nelitolimod across several high-value oncology indications. This transition will eliminate the vast majority of development-related expenses for nelitolimod by the end of 2025, while preserving the program's potential upside. It also allows us to focus internal resources on the near-term high-impact opportunities within our PEDD platform. Phase I studies of nelitolimod in multiple liver tumor types, which include metastatic uveal melanoma, hepatocellular carcinoma or HCC, cholangiocarcinoma are now complete. Enrollment has also concluded in PERIO-3, our Phase I trial in locally advanced pancreatic cancer with final data expected by year-end. Clinical study reports for all 3 PERIO Phase I dose escalation trials are in preparation with data releases anticipated in Q4. We're currently finalizing reports and data presentations to support future partnership discussions. Completion of enrollment and closure of these studies will drive a reduction in R&D expenditures in the second half of 2025, and we continue to support several ongoing investigator-initiated studies. Before turning the call over to David for a review of our third quarter financials, I want to reiterate that TriSalus remains focused on executing our near-term milestones, including advancing the TriNav platform across multiple indications focused on the interventional radiology call point, advancing PEDD solutions designed to optimize therapeutic delivery and address the full spectrum of vascular access and perfusion challenges faced by the interventional radiologist, generating and publishing new clinical and HEOR data to validate the effectiveness, safety and economic value of our technology, enhancing operational performance in our manufacturing and improving gross margins and also building a scalable, high-growth organization. As we look ahead to the balance of 2025 and into 2026, we're energized by our long-term vision of bringing our PEDD technology platform to a broader range of patients, improving outcomes and redefining standards of care. TriSalus remains a science-driven organization with patients at the center of everything we do. Our progress continues to make meaningful difference for people living with liver, pancreatic and other solid tumors. And with that, I'll turn the call over to David. David Patience: Thank you, Mary. As Mary mentioned earlier, TriSalus delivered another strong quarter. For the 3 months ended September 30, 2025, revenue was $11.6 million, representing 57% year-over-year growth and 3% sequential growth versus the second quarter. This continued momentum reflects the exceptional performance of our commercial team and the expanding adoption of the TriNav for liver embolization procedures across a growing customer base. In the third quarter, we increased the number of unique ordering accounts by 30% compared to the third quarter of 2024, adding 20 new accounts while also achieving higher utilization per account. Sequential growth reflected expected seasonal trends, a temporary dip in July was driven by lower procedure volumes followed by record levels in both August and September. The gross margin for the quarter was 84% compared to 86% in the prior year period. The modest decline was primarily due to lower manufacturing efficiency associated with newly launched products, a dynamic we expect to improve in the fourth quarter as production stabilizes. Research and development expenses were $5.2 million, up from $4.2 million in the third quarter of 2024. The increase was largely attributable to a onetime charge of approximately $2.1 million related to the closure of our clinical studies for nelitolimod, partially offset by the revision of approximately $700,000 in patent-related costs to general and administrative expenses. Excluding the onetime charge and the revision, R&D spend was down about $400,000 year-over-year. Sales and marketing expenses totaled $6.8 million compared to $6.1 million in the prior year. The increase was primarily due to higher performance-based compensation reflected by our strong commercial momentum. General and administrative expenses were $6.7 million, up from $4.7 million in the third quarter of 2024, driven mainly by the acceleration of approximately $1.6 million in noncash stock-based compensation and the revision of approximately $700,000 of patent-related expenses. Excluding the onetime accelerated stock-based compensation and revision of patents, G&A was down $300,000 year-over-year. Operating loss for the quarter was $9 million compared to $8.7 million in the prior year. The increase was primarily driven by the onetime charge related to the closure of our clinical studies for nelitolimod and the noncash stock-based compensation acceleration in the period. Cash used in operations was $3.7 million, a substantial improvement versus $11.2 million compared to the third quarter of 2024. Adjusted EBITDA loss was $5.4 million, an improvement from $7.1 million in the prior year. This includes approximately $2.1 million in onetime charges related to the PERIO study closeout. The improvement in adjusted EBITDA reflects stronger sales performance, lower underlying R&D spend and disciplined operating expense management. Our cash burn for the quarter was approximately $3.8 million, bringing our quarter end cash and cash equivalents balance to $22.7 million. We believe this provides us ample liquidity to fund our operations and strategic objectives. Subsequent to the quarter, we amended our debt agreement to reduce the minimum cash covenant from $10 million to $5 million, providing additional balance sheet flexibility. As Mary highlighted earlier, the preferred conversion completed in July simplified our capital structure, eliminated the 2027 preferred stock reset provision and better aligned our long-term investor base for future growth. With that, we're ready to open the line for questions. Operator: [Operator Instructions] And the first question comes from Frank Takkinen with Lake Street Capital Markets. Nelson Cox: This is Nelson Cox on for Frank. Congrats on all the progress here. I want to start with 2026. I understand you guys are not guiding for that today, but just any color you feel comfortable providing there in terms of how we should be thinking about growth in 2026. When I look at kind of where the Street is at, there's kind of a wide range. So just wanted to give a chance if you guys are comfortable to provide more color there. David Patience: Yes, Nelson, this is David. Thank you for the question. Right now, we're confident and very excited about our current momentum, especially in the fourth quarter. So that's really our focus right now. We are maintaining our guidance thus far of the 50% growth and adjusted EBITDA positivity in the first half of next year. But other than that, we're pretty focused on the current operations of the business, and we're excited about it. Nelson Cox: All right. Fair enough. And then -- kind of curious if there's any additional color you can provide outside of liver in terms of growth you're seeing in your other indications. Mary Szela: Yes, I can take that, Nelson. One of the things that we're doing right now is we're investing in some of the new applications that our technology can be used for. And yesterday, we had a webinar on uterine artery embolization, and we are right in the middle of our market evaluation for one of our new products, and we're really excited about it. I think this is a product that can be really meaningful for uterine artery embolization, help reduce procedural time, help reduce the amount of embolics that are used, which correlates to reduce pain. And the other important thing is just reduce the administration of embolics into the myometrium tissue, which can cause a lot of post-procedural pain. So we think this could be a major opportunity for us in 2026. We'll enter our full launch in about a week. But already, just based on the feedback and just the utilization and the market evaluation, it's been really robust. I think we mentioned too on our earnings remarks that we are in the midst of a genicular artery embolization trial. That's something that we'll continue to invest in and move even further. We have a new product launch coming in the fourth quarter, which is TriNav Advance. And this one, we think, could be really interesting for us because this is a technology where the interventional radiologist has the potential to use any microcatheter. And we think that could open up the opportunity for other different procedures. I'd like to have Dr. Richard Marshall comment on this. He's actually used this product and also used our XP and maybe you can comment on those as well, Dr. Marshall. Richard Marshall: Thanks, Mary, and good afternoon, everybody. So I am very excited about both the XP, which is our product for uterine artery embolization that's currently in limited market release, and the feedback has been great. This will allow physicians to use a TriNav in a part of the body where they couldn't use it or it was very difficult to use previously. The same thing goes for our genicular artery embolization. So currently, we have a pilot trial going on to evaluate this. But in Q4, we'll be launching the advanced product, which will allow physicians to get deeper into these arteries with their favorite microcatheter. So we're going to be giving them the effects of a TriNav, but they're going to still feel like they're using and be able to treat patients like they normally do with their favorite microcatheter. So I think that's going to provide a lot of opportunity, especially in really small arteries and smaller parts of the body like genicular arteries, which is a growing area of treatment. I've been able to use these products. The advance, I have not used in a human yet because it's not available. But I can tell you my experience with it in pigs has been phenomenal. And I think it's going to generate a lot of excitement and expand what we can do, the number of patients that we can treat. Operator: And the next question will come from William Plovanic with Canaccord. William Plovanic: I think as we come into the year, I mean, I just want to -- the revenue was a little light for the quarter. I appreciate the cadence comments regarding August, September. I think that gives you the confidence to finish out the year, which I think consensus is sitting right about that $45 million. But I do think going back to the first question was asked, I mean, there are estimates out there that have over 50% growth next year and up to almost 90% year-over-year growth next year for some of the sell-side analysts. So I understand you don't really want to comment, but is there any reason you think that your revenue growth could accelerate above 50% in '26? David Patience: Yes. No, I think it's a great question. So we have not managed the Street to the 2026 numbers. I think those that are closest to the story are pretty familiar with kind of where we see the growth of the business. And we're just not ready to comment on 2026 just yet. We're very focused. We appreciate your understanding and the first quarter being $9 million and then 2 quarters of over $11 million in a row is exactly how we forecasted and we're on target and tracking towards that 50% growth, which will be a nice step-up in the fourth quarter. September was a record month for us, just to close that out and very strong momentum for us. And it was the best month ever for our company. That said, we just don't -- we don't want to comment on 2026 just yet. We're very focused, but confident that we'll hit our 50% growth target. William Plovanic: And then just a follow-up. As we think about the use case -- use cases for mapping, it doubles the opportunity. What percentage of your case mix today is mapping? And then if I could squeeze in just what are you seeing in terms of the new account penetration going deeper versus new account additions as drivers for you? David Patience: Perfect. Yes, I'll take the last part. Our new account additions, we are adding about 20 accounts through VAC approval for the quarter. Again, our focus going into this year was opening a lot of accounts, excuse me, were already opened, and we are driving deeper penetration, as you commented. And so our utilization is continuing to grow on a quarterly cadence per account, and that is really driven by new physicians spreading word of mouth using TriNav where we used to have 1 champion. Now we have 1 or 2. And then the newer applications will play a big role as those interventional radiologists are going to be using us not just for the liver. And so to answer your question, very focused deep penetration within each account to improve utilization, and we're seeing that in the numbers, and that's what we're excited about. And I'll turn it over to Mary to talk about mapping. Mary Szela: Bill, thanks so much for a good question. Yes, mapping has actually been a very important driver for us in the back half of the year. I would -- we estimate, and this is based on our -- we don't really have detailed market data or external market data. This is based on our Veeva internal data from our representatives. So we're estimating about 30% of our growth is coming from the mapping. Remember, about half the market is radioembolization. Half the market is chemoembolization. They don't do mapping in the chemoembolization. So we're really seeing kind of a 2 for 1 in the radioembolization. And the other factor has just been because it's a new code and it came out in April, we're working -- we have a reimbursement resource with Dr. Z. We're still having some bumps with that where people are just not familiar with this code. So we've really gotten through some of the bumps along the way, and we're starting to see that accelerate. So that's been very helpful for us this year. Operator: And the next question will come from Ross Osborn with Cantor Fitzgerald. Junwoo Park: This is Matthew Park on for Ross today. I guess just starting off, as you initiate the genicular artery embolization study for knee OA, I guess, how do you view the broader competitive landscape developing around here? And where would you see TriNav fitting in within the potential standard of care? Mary Szela: Sure. So GAE is a really exciting opportunity, I think, not only for patients because it can potentially reduce the need for a knee surgery or more fundamentally, it just addresses the immediate pain that these patients are in. We're a drug delivery device. So where we see a lot of the competition coming in this is really around what type of feed that they're administering. Are they resorbable? Are they -- is it different types of drugs that they're administering. And I think the key that we believe that we offer is that we can penetrate these vessels much more deeply, and we can actually protect against off-target delivery. And I'll have Dr. Marshall comment about this because he's been involved in our early cases and our pilot study. And this is -- this drug delivery, we think, can be a very important one in this procedure regardless of what's being administered into the vessels. Dr. Marshall? Richard Marshall: Thanks, Mary. I think you highlighted some really good points. The most difficult thing about these cases is being able to deliver particles or liquid into these genicular arteries. It got to go deeply without having it go into places where we don't want it to go. So obviously, the foot is distal or downstream from the knee. And so that's what we all want to protect. And TriNav, with both its flow modulation and reflux protection accomplishes both of those. So it is -- this procedure is already being performed with traditional microcatheters. The interest that we've received so far and the success that we've seen is that physicians do an angiogram with the TriNav and they say, they can see vessels a lot better. And then when they deliver their microspheres or their liquid embolic, they can push it in much further without having to worry about nontarget embolization. So they feel safer and more confident. We've got some other positive feedback that we're going to publish in the near future about how we can treat multiple sites from one injection. And I think that's going to -- that is going to distinguish this catheter from the traditional way of treatment. It's going to allow physicians to do this procedure faster and better. Junwoo Park: Got it. That's super helpful color. And then maybe one for David. So on gross margins, you called out some headwinds in the quarter driven by these newly launched products. I guess how should we think about the cadence of gross margin over the next couple of quarters and when you would kind of expect these manufacturing efficiencies to come back in? David Patience: Perfect. I think the short answer is the fourth quarter we'll see an uptick. We've done -- we've thrown a lot at our manufacturing team with 4 new products and 8 new SKUs in 1 single year, but we're proud of kind of where we've evolved our processes, our procedures and our lot sizes to really scale efficiently. So we should see normalized gross margins here in the fourth quarter and then expanding early next year as well. Operator: And our next question will come from Carl Byrnes with Northland Capital Markets. Carl Byrnes: Congratulations on your progress. Going back to TARE mapping, what have you experienced with respect to conversion of existing TARE users with TriNav to mapping? Is it -- I know you mentioned that there's some education process around the new HCPCS code, the C8004 code. Are you -- can you quant that at all? I know you quanted the revenue growth of 30% for mapping, but do you have any feel there? Mary Szela: Yes. That's -- I mean, I think what -- the data that I have is what I shared with you that comes out of Veeva. I think all I could really offer you is anecdotal data. Maybe I'll have Dr. Marshall respond. Dr. Marshall, how do you think about this? Just the impression that we get from physicians now is everyone likes to map with the same technology that they treat with. You want to make sure that what you see in the initial session is what you're going to define your dose on and how you're going to treat the patient. And I think that's been a big message for us as we interface with physicians. And that's been the big conversion because they've been doing -- oftentimes, they'll do it with an endhole, then they'll want to treat with an endhole. So now we're converting 2 catheters versus the 1, and that's really what's been driving the majority of the upside. But to your question, I don't have that definitive data. Dr. Marshall, do you want to weigh in? Richard Marshall: I do. I'll reinforce it. I think physicians want -- they basically want to treat apples and apples. They don't want to map with 1 catheter and then treat with another because when they give Y90 or this radiation, they can't take it back. And so it has to do what they think it's going to do. And I think physicians have been really impressed with the angiography quality that they get from TriNav because of the way that contrast goes through it and is pressurized into arteries, they can see things better. And so that's a lot of the feedback that I get is not only can I map with the same catheter that I'm treating with, I'm actually seeing things and sometimes seeing more tumors. So the feedback has been very positive. We do still have some education to do for physicians who understand that they can use the catheter and it's covered by insurance or Medicare, Medicaid with a CPT code. Carl Byrnes: Great. Very helpful. And then just one quick follow-up. What are you seeing with respect to adoption of LV and FLX and in what procedure specifically? Richard Marshall: I can comment on this. So we have centers that have converted completely to FLX that they love the catheter and they only want to use that. Those are centers that typically do more selective treatments. So smaller portions of the liver and smaller arteries that may be that are a farther distance for the catheter to travel. And so they appreciate the trackability of that catheter being able to go out farther. Whereas others are -- seem to be more comfortable, but I think we've had a lot of users convert to FLX. It's been very well received. LV has helped us in areas where TriNav really shines. And those are really large territory treatment. So for example, half of the liver, we call it a low bar treatment or an entire lobe of the liver. We can -- that valve is larger. And so some patients, for example, with primary liver cancers, hepatocellular carcinoma or metastases that receive a lot of blood flow like neuroendocrine tumors. Those arteries are larger. And so this is a nice fit in both of those scenarios so that the valve can fit appropriately and they can actually inject more contrast and particles faster because it's a larger catheter. So I think people really appreciate that. Outside of the liver, we've seen some use of TriNav FLX in thyroid arteries because they are tortuous. So it's a nice fit in that area. And the same is true -- was true in uterine artery embolization, but the XP catheter, which we've just released is going to be, I think, it's going to have a lot of growth in uterine artery embolization because it's designed specifically for that. That's been well received so far. I hope that answers your question. Mary Szela: Yes. That's really helpful color, Dr. Marshall. And I think I would add, we saw FLX. We didn't anticipate this to be this robust, but it's already about 35% of our mix. TriNav is at 50% and the large is at about 15%. But we're seeing FLX grow every month. It's been a bit of a race to keep up with how that -- from a manufacturing perspective and how that's growing month-over-month. So it will be interesting now then to see XP. That's been our manufacturing challenges, how -- and remember, we have a single price for all these products. So it's really up to the use of the physician, the type of vessel tortuosity. And so we're just -- that's part of the inefficiency in manufacturing is just trying to estimate how this is changing month-over-month. We think that's going to settle out probably over the next couple of months in 2026. Operator: And our next question will come from Justin Walsh with JonesTrading. Justin Walsh: It's great to see you exploring different use cases for TriNav. I'd love to hear your thoughts on the long-term mix of uses if some of these indications are more likely to be more significant than others. Mary Szela: Yes. So that's a really good question. I think when we first looked at our procedural code, there's roughly about 40 different embolization procedures that we could potentially be used for. So we picked ones that we think really have the most significant near-term patient benefit and market benefit. And when we think about uterine artery embolization, kind of the estimates for those markets are probably between -- we've seen the low at the 110, higher at kind of the 250, that could be a significant market opportunity for us. But probably the biggest one that we think that could really even rival the liver market is really GAE. And just based on the patient volume and just the enthusiasm. In fact, we met with a big group of interventional -- not interventional -- radiologists and also some orthopods and they were even excited about potentially using this procedure for even people who have had surgery. 2 days postoperatively, patients are still in enormous pain, and they were thinking about how do we incorporate this procedure to help allow them to do physical therapy more appropriately and recuperate much better. So that's a market that could equal the size of the liver or actually be even higher than that. Maybe I can even have Dr. Marshall talk about that. The thyroid market being very comparable again to the uterine artery embolization, but there's more even beyond these. This is all the ones that we're focused on right now. We've got quite a bit on our plate, but we really believe this type of embolization approach can really benefit patients in terms of minimally invasive surgery, often can take a surgical procedure and make it more cost effective for the payer, a better outcome for the patient and potentially be used in combination with other treatments as well. So Dr. Marshall, do you want to comment on that? Richard Marshall: Yes. And so we're talking about delivery of embolics right now, and we still have more room to grow in the liver, obviously. But the -- I think the elephant in the room is genicular artery embolization, just the number of patients that have osteoarthritis. And with a population that's aging, the number of knees that are going to need to be treated in the future is going to grow quite a bit. So we have a great solution for that, and that's why I think it's going to be a huge area of growth for us. Operator: And our next question comes from Suraj Kalia with Oppenheimer. Shaymus Contorno: This is Shaymus on for Suraj. Just one from our end, but just trying to cut this, I guess, two different ways. So how has kind of growth/utilization look for accounts that launched, say, 18 months ago versus 1 year ago versus 6 months? How kind of -- has the ramp kind of been increasing over time? And I guess, could you kind of quantify that? And then on a separate note, again, on utilization, how does utilization for a physician that's added on with an existing account look over time? Mary Szela: No, that's a really good question. We segment accounts into 2 major buckets. And oftentimes, if an account really hasn't had any education about the tumor microenvironment or some of the challenges associated with interstitial tumoral pressure and the challenges associated with it. We call that a bit of a cold account. That's going to take a little bit longer. So it really depends on the type of account, an account that's more familiar with that, that's a much faster ramp. But overall, we see accounts that we started 18 months ago just continue to improve month-over-month. And a lot of that improvement is we get one user in account, they're using it very consistently. And I think one of the things that we've also seen in parallel is as we offered these new options of devices, it allows that single physician to use more and more cases because we didn't have really the best technology for that particular patient. So we're seeing that current user grow in a deeper amount of use within his patient population, and we're also seeing the new users kind of start down that path. So if it's an account that is receptive and educated along those lines, we see a more rapid uptake. If it's an account that doesn't have that information that we're starting a little bit from ground zero, and we need to do some of that education and really get them familiar with the technology and the rationale and then they get to see the technology and use. And those take a little bit longer. So those are the two buckets that we have. And I don't know, Dr. Marshall, you can talk about it as well, but we're seeing -- I think what we're excited about is we continue to see the continual utilization grow pretty steadily, and it seems to marry how we've launched these new products, too, because now we've expanded the options for them to really address any vessel size or vessel tortuosity that they see in a particular patient, and we think that's going to accelerate over time. Dr. Marshall? Richard Marshall: Yes. I think we typically see a single user at a site become a champion for us and start to use our catheter. And these older accounts where a physician has been treating patients and seeing the results and they show them to their partners, then partners can start to understand, okay, maybe there really is something to this if they're not educated about the tumor microenvironment. 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