Conference Transcript - TVTX 2026-08-11

Speaker 2

Hi. Good afternoon, everyone. My name is Edward Nash, Senior Biotech Analyst at Canaccord Genuity and the Equity Research Team. It's my pleasure to have with us Trevier Therapeutics. From Trevier, joining us, we have Chris Klein, who is the company's Chief Financial Officer. Thanks very much for joining us today.

Speaker 3

Thank you very much for having us.

Speaker 2

So maybe to kick off the conversation, if you could just give us a 10,000 foot view on Trevere and mainly kind of focus on from the company's clinical focus, and then we'll dive into the individual programs as we go forward.

Speaker 3

Sure, happy to do that. And before I jump in, we will be making forward-looking statements, so please review our disclosures on our forms 10K and 10Q and less with the SEC. At Trevere, we are exclusively focused on rare disease, and we're a commercial-stage biotech with really a key focus on four main pillars. And the first two pillars are focused on Phil Spari, which is the only approved dual endothelin angiotensin receptor antagonist. And there, it's really focused on driving both our near- and long-term growth. And the first of those two pillars is continuing the momentum that we have built over time with IgA nephropathy. And for those of you that are familiar with the IGA nephropathy market, we've really seen a great evolution of more and more treatments becoming available for patients. And Phil Spari has been able to develop and maintain a foundational positioning there. And our goal here is really to continue that positioning and maintain our strong growth as we go forward here and as you see more entrants coming into the market. The second pillar tied to Phil Spari is going to be the continued strong uptake in FSGS. So we just got approval for our second indication for Filspari and FSGS in April. And what we've seen so far in the launch has been a very strong start and very encouraging trends from a demand perspective. And our focus really is to make sure we can keep that going. And those two together will really be big drivers for Filspari's growth in the near and long term. The other two pillars are tied to our pipeline. As you mentioned, the clinical activity. and there we've got the potential for two best-in-class medicines. The first is pectobatinase, so that's going to be our third pillar where we're really focused on advancing our Phase III Harmony study. This is a pivotal study of pectobatinase, the first and potentially only disease-modifying therapy for something called classical homocystinuria, and that's a rare disease that typically has very limited treatment options and affects roughly 7,000 to 10,000 patients in the U.S. and abroad. So a great opportunity there with data coming up in the near term. And then the fourth pillar, and really focused on driving that long-term growth, both alongside and beyond Phil Spari, is the newly in-licensed C-borbrutinib. This is a next-generation BTK inhibitor that we recently brought into the pipeline. and there we see a really great strategic fit to not only add to our pipeline but also to extend, again, the growth potential both alongside Phil Spari and pectobatinase through multiple rare kidney indications. So a lot going on in the company. We've made great progress and excited to jump into some of that.

Speaker 2

So you definitely were – I'm always happy when the companies beat our number and consensus, and you guys did a great job with that this quarter, being the first really full quarter, I guess, with FSGS on board. You already talked about the strong growth there, but did it internally seem to beat your expectations as far as its performance? Well, we had high expectations going into the launch.

Speaker 3

I think that there is a very clear need for the first medicine approved in FSGS, and our commercial and field teams were ready. Not only had we been preparing for quite some time, but also we were able to leverage our learnings from being in the field with IJ nephropathy, and there's significant overlap there. So we had expected to have very high demand and to hit the ground running from an execution standpoint, and what we saw did exceed our expectations. I think the most notable aspect of that is the breadth of demand that we've seen. We've been very pleased to see that you have a very wide prescribing group of physicians early on here, and we expect that to be able to continue.

Speaker 2

And I assume Parasol was a real big help for that, I guess, with physicians and really realizing that proteinuria really is what you should be focused on with the treatment of FSGS.

Speaker 3

Yeah, I think Parasol certainly played a role in helping everybody in the nephrology community understand the importance of proteinuria in FSGS. And it gave something for people to talk about over time when we were working through the process with FDA and how that regulatory decision was unfolding. And so that definitely heightened the awareness of FSGS and potentially Phil Spari coming to market.

Speaker 2

So from the second quarter results or from internally, have you seen any evidence there's any warehousing of the drug at all or is what's going out is going directly to patients?

Speaker 3

No evidence that we believe of a warehousing effect or a bolus. You know, some people use that term. Really, we look at those as acute increases in demand or acute starts in demand that then decline significantly thereafter. we're not seeing any evidence of demand trends that would support that. Really, what we look at is taking a step back at the market as a whole. More than 30,000 patients out there that would be qualified candidates for Filspari, so you're talking about a meaningful population to start. We expect that to also grow over time as those patients that are in a current nephrotic state come out of that. But I think that the most important telling piece of what we've seen so far in launch is again going back to that breadth of prescribers so we've seen a very wide range of physicians writing and the vast majority of those have only written one script thus far in launch so when you think about on average for the nephrologist community you've got a handful or more fsgs patients they're just in the early stages of writing to their patients and so we expect to see continued demand as we go forward do you guys internally have any thoughts on what what you think your ultimate ability to address the whole market will be, what precedes that market.

Speaker 2

I mean, you're the only drug out there, right? So not really sure what would be holding physicians back. We don't have safety issues with the drug. And clearly, like you mentioned, this is the first drug approved, so you would expect you would see an even greater conversion rate as you move forward the longer the drug's been on the market.

Speaker 3

We certainly have very high hopes for Filspari, and I think we are uniquely placed in that we are the only approved medicine for FSGS. When you think about the numbers that we provided from an opportunity perspective, the more than 30,000 patients are those patients that are currently identified in the care of a physician, biopsy confirmed, and are aligned with our label. So that states those patients that don't have active nephrotic syndrome. What the 30,000 or the more than 30,000 doesn't include are patients that can come out of that active nephrotic state. So if you treat a patient with either diuretic or you address the proteinuria, elevated proteinuria up front, you can get them to become out of the nephrotic state and then would be eligible for therapy. The other thing that we expect to occur is even more diagnosis to occur as now there are tools specifically for Spari to be able to address their FSGS. I think you're going to see greater biopsy rates and earlier identification. So, you know, we do anticipate that docs are going to continue to reach for Phil Spari for all their FSGS patients that would be aligned with the label, and we expect that number to continue to grow.

Speaker 2

So this would be the phenotypic evolution over time of what you would see of how doctors would continue to treat over the entire group of nephrotic patients?

Speaker 3

Yeah, there's not a reason to believe that Phil Spari wouldn't be applicable for any particular type of FSGS. It's really getting to those patients that don't have active nephrotic syndrome and have diagnosed FSGS. So I think it's very well suited for what physicians have really been looking for now for decades.

Speaker 1

So I'd like to switch to IgA nephropathy for a little bit. Because, you know, since the drug first launched, or like its initial accelerated approval more than two years ago, it's been demonstrating strong and continued growth. And with the first quarter of this year, you reported more than 990-ish patient start forms for that quarter. And in second quarter, the total patient start forms, including both indications, FSGS and IGN, together is over 2,000. So I would like to ask you about, you know, moving forward, how do you see this opportunity in IGN evolving?

Speaker 3

Sure. So we've been very pleased with the continued progress in IgA nephropathy. And, you know, I mentioned in the early remarks that Phil Spari is the most prescribed medicine for IJ nephropathy, and we don't see anything that takes that opportunity away from us in the future. You know, just in terms of growth, you have it right. We had more than 900 PSFs the last two quarters that we reported that specific indication, and we said on our 2Q call that we saw growth, sequential growth in IGN. So continuing to see robust demand there, and we would expect that to continue. If I take a step back, you know, we've provided guidance that we believe Phil Spari as a whole has the potential to reach more than 100,000 patients, so more than 70,000 patients for IGA, more than 30,000 patients for FSGS, and that's a peak sales opportunity of more than $3 billion. So for both of these indications, we believe we've got a long ways to go, and we're excited about the opportunity to be able to help patients.

Speaker 1

Sounds great. So you recently announced the allowance of the method of use pattern for iGEN. And could you tell us more about, you know, what does this mean for Fillsbury loss of exclusivity?

Speaker 3

Sure. So we're not commenting specifically on loss of exclusivity, but we are very pleased with the recent notice of allowance. And so that came through in June. That was specifically directed at certain uses in IgE nephropathy. and we do expect that to be granted here in the near term and then we would expect that to be orange book listed. That would go out to October of 2037 and so that's very pleased with that progress. We also have a similar patent that we're prosecuting for FSGS with the USPTO at the moment as well.

Speaker 1

Do we have an estimate about when will we hear more feedback on the FSGS site?

Speaker 3

I would love to be able to give you a date but unfortunately it's an iterative process without hard dates to point to.

Speaker 1

Yes, of course. So you mentioned, you know, at the beginning of our discussion about the ongoing Phase III Harmony study for Bactobatinase in HCU, which is actively enrolling, and can you speak to timing for a readout from this trial? And how do you see the, you know, assuming impactful positive data, what would you expect, you know, the impact for this program?

Speaker 3

So pectobatinase continues to be a very exciting opportunity for us. If you take a step back and think about classical homocystinuria, you're talking about roughly 7,000 to 10,000 patients in the U.S., similar numbers in Europe. About half of those are addressable, and we say half because, unfortunately, diagnosis is quite poor for HCU. So in HCU, there is testing on newborn screening where you can measure methionine levels, but those aren't always elevated at birth, and so oftentimes patients are missed. And the currently available medicines or treatment options are very limited. And so there is a clear need for something that can lower total homocysteine levels and get patients to below 100 micromoles or 50 micromoles, the two key levels that physicians are really aiming to, to help patients avoid really awful clinical outcomes such as cognitive decline, ocular lens dislocation, osteoporosis, and stroke, or ischemic events such as stroke. So we're very hopeful that the HARMONY study will be able to read out positive data in the second half of next year. That's our guided time frame, and in that, we would hope to see a robust reduction in total homocysteine levels. We saw that in our phase one, two composed study, in our highest cohort, we saw roughly 67% reduction from baseline, and we got all patients below that important level of 100 micromoles. So if we can replicate those data or even get close to those data, I think it's going to be a very important tool for physicians as they're looking to address the decline that comes with classical almost cystinuria. And for patients, it would be the first treatment option that truly is effective and gives them hope for a better future.

Speaker 1

Then how should we think about the HCU market opportunity?

Speaker 3

Sure. So, again, it's about 3,500 patients that are addressable in the U.S. today, a similar number outside the United States, and we expect that number to grow. You typically see that in rare disease, once you have a treatment that's identified or that's approved, you tend to see an uptick in identification of patients with education awareness, we would anticipate that. But also going back to what I had mentioned about the diagnostic process, right now there are clear gaps there. And I think that there are some efforts that we would be able to help facilitate in order to improve that over time. And so I think that the addressable population is only going to continue to grow for HCU, and that's where we believe we have a really meaningful opportunity.

Speaker 2

Does that also apply to FSGS, or was FSGS never difficult to identify? We knew it was there. We just didn't have a treatment option. Or do you believe now that we have a therapeutic, there's also perhaps patients out there. Maybe it's a bigger market because of this identification because we now have a therapeutic.

Speaker 3

I think there are elements of it that are applicable to FSGS. In FSGS, you do have better diagnostics, right? So genetic testing and biopsy can more clearly confirm FSGS. But you also have secondary FSGS that is secondary to other things like, you know, whether it's diabetes or something else where you may take more time to actually get to that diagnosis. And I think that now with a treatment approved specifically for the disease, you're likely to see physicians seeking out a biopsy confirmation earlier and treat as soon as they possibly can. So I do think that there's an element there that we will see more FSGS patients identified over time.

Speaker 2

So you mentioned earlier in your comments that you just recently entered into the license agreement with Everest for a BTK inhibitor. So maybe could you talk a little bit about that molecule and how you're seeing that fit into the overall pipeline of Truvier?

Speaker 3

Sure. From a FIT perspective, you know, we have a very clear, built, strong infrastructure for rare renal, right? So if you think about what we've done with Phil Spari, we ran two large Phase III studies in addition to a whole bunch of other efforts for evidence generation, and all of that clinical infrastructure would be directly applicable to the early days with Sivorbrutinib, or SIVO just to make it easy, as we look to establish the clinical development program there. Bigger picture, we also have the regulatory even recent experience on navigating pathways based on new or developing data sets within rare kidney space and working with cardiorenal on clear endpoints in the space. And so we'll be able to leverage all of that as we get into the regulatory phase. And then when you think about the commercial aspect, this fits perfectly in with what we currently have because there's a complementary element of it with Phil Spari where SIVO can potentially address the immune-mediated aspect of something like FSGS, whereas with Filspari, we're really focused on addressing the overactivation specifically within the kidney. And so there's that combination that you could use both independently together in the future that I think can be very beneficial. And so, you know, from that perspective, it's a clear fit from the rare renal side for us, and it layers in potential growth both alongside Filspari and Begtab adenase and then extends it beyond those as well.

Speaker 2

So some of these additional indications that it would be addressing that Filspari is not currently addressing, how big are those additional markets? And also, are there any other drugs that are currently approved to address those?

Speaker 3

Sure. So there's three indications that we've identified thus far, and if you think about the prevalent population for those three combined, it's around 130,000 patients overall. And so there's a meaningful opportunity to reach a significant number of patients. And that covers PMN or primary members of nephropathy, immune-mediated FSGS, and minimal change disease. So I think that there is a great opportunity there to be able to help patients. There is nothing yet approved for PMN. There's likely to be something soon. Nothing yet for minimal change. In FSGS, obviously, we have Phil Spari. but this would be more focused towards the immune-mediated specific aspect of FSGS, so it layers in very well.

Speaker 2

So all of these are orphaned indications we're talking about. And then as you think about, I mean, this was great timing to be doing this, right, because you've kind of now gotten two indications on the FSGS has been watched by the street for quite some time. You got through the whole regulatory process, got that drug approved, so you've got the two indications there. You you're now able to achieve something that I think it's been difficult for a lot of biotech to do right is we've done this We got run approved now We've got to find something else that's in the area that we're looking at right rather than saying oh now We're going to be looking at cardiovascular disease right for a renal company so But but it's kind of probably hard to replicate that on a continual basis So how are you thinking about beyond city when you go out further?

Speaker 3

Yeah? Yeah, I mean, it's always tough to do it again, right? But I think with SEVO, we've really found a great opportunity to do that because it fits all those bills that I had mentioned before where you've got the very clear alignment with our internal expertise and our recent progress. And I think that there are potentially other opportunities out there to layer into our pipeline. And whether that's continuing to leverage the rare renal focus or even the rare metabolic focus right so with peg t we've developed a different expertise that is you know more towards the ultra rare side and obviously on the metabolic side but there are interesting things on that front as well that could potentially be good fits for us so we're going to continue to be very choiceful in what we're looking to add into the pipeline but we're going to you know continue to look and see if there are other opportunities that we can keep keep going with the success we've had so far So in Europe, you have a partner now with Filspari, and that also accounts for FSGS as well, right?

Speaker 2

So it's the drug for all indications that are there. So for CIVO, as you're developing this drug, are you going to be looking to do kind of the same BD opportunity for Europe as well, or is this something you would potentially want to do commercially on your own? Normally, I would think most biotechs say we would want to get a partner, but I do have a couple in my universe that have gone out and decided to do their own commercial opportunities in Europe, for better or for worse, in the face of MFN. So just wanted to get your thoughts on that going forward.

Speaker 3

Yeah, and maybe it's worth taking a step back in time to what we did with Phil Spari prior to getting to the collaboration with, at the time it was V4, and now it's CSL after CSL acquired V4. The way we approached that was we did parallel tracking, so we were looking at plans to go ourselves and build the infrastructure and do all the work in Europe at the same time as we were going to be launching in the U.S., and we were also evaluating potential partnerships, and so I would anticipate that we'll do the same thing here and we'll make the right decision at the right juncture. It came down to, for us, with the European collaboration that, at the time, V4 had a very clear expertise in rare renal in Europe. They were absolutely the leader over there, and it was clear to us that we were going to have a lot that we needed to execute on very well in the U.S. with two indications launching in what we thought was going to be a pretty close period of time. And so there it made sense to do our agreement with V4 and advance that. We'll see how that goes with SIBO, but I think we've also built up a very strong infrastructure now already that we can leverage in the U.S. that may give additional bandwidth down the road.

Speaker 2

So, you know, one of the things that's kind of impressed me in the whole renal space is specifically with IGAN is that we went from really nothing to just, well, you know, lots of drugs very quickly, right? And you guys were one of the first ones to get out there and get approved, I guess, a real molecule that wasn't something like a steroid, right, that was getting approved. So this is now, the space has been transformed a lot, and we're hearing a lot about, more about April and Bliss and stuff. Just like maybe if you could just talk a little bit about that, about, you know, where you fit in and what the shortcomings are of some of these other mechanisms versus the dual mechanism we have for Phil Spari.

Speaker 3

I mean, it's been great to see the evolution in the IGA space. I think it's amazing that patients have many options now, right? To your point, if you go back even five or eight years ago, you probably had two or three clinical trials in development, and now we've got multiple options for patients to choose from on the commercial side of things. So, you know, what I think is important to remember is from the KDGO guidelines, which is basically one of the main governing tools for physicians, it tells you that you need to address the overactivation in the kidney and you need to address the overactivation in the immune system. So you need to be able to tackle both of those things. and the main goal is to get patients to 0.3 or 0.5 grams of proneuria, so basically complete remission. And so in order to be able to do that, for many patients, it's going to require combination therapy. And so, you know, that's been our view for quite some time, that we'll be able to get some patients there on Filspari. You'll be able to get some patients there on other modalities. But at the end of the day, to get the vast majority of patients all into complete remission, you're going to have to have combination therapy. That's what the K-Diego guidelines say. You know, I think as it comes to specifically the April class and the next generation of medicines that's coming, the data look very encouraging. It's exciting to have treatment options. They're certainly going to get utilization. It's important to remember that they're all trialed on top of standard of care, right, ASARP, and that's really what we're aiming to replace. We're not aiming to replace the historical role of steroids or TARPA or other things. So that's why we believe that we're going to continue to have that foundational positioning and will continue to be used in combination with the other medicines that are coming forward. And at the end of the day, it's great for the IGA community because they're really going to have the ability to get into remission.

Speaker 2

So is this kind of, you know, I guess I've always seen and I've always heard when I talk to other docs and other indications, they always say the nephrologists are the real thinkers. They're the smart ones out there.

Speaker 3

It's just wanted to understand what feedback you're getting from them with regards to these other mechanisms is what you're stating is how they're thinking on how they would eventually incorporate some of these other mechanisms into their practice it's very aligned with what we hear from the nephrology community i mean we we base a lot of our thinking we try to incorporate that very early on in all of our planning and i think you you obviously hear evolution over time as you see more data, and there's certainly excitement for the new generation of medicines. But they also look at it the same way that KDigo does and say, okay, this is great. Now we've got two things that we can use together, and patients are going to benefit. So we're certainly hearing that, and we're seeing early but anecdotal evidence of that combination occurring in the commercial setting. So we are seeing Filspari being used with SGLT2s. We're seeing Filspari being used with some of the new Aprils. We're seeing Filspari used with Tarpeyo and some of the other steroids. So I think that that movement is clear, and the thing that is most consistent amongst all nephrologists, they now finally believe in that target of 0.3 or 0.5 proteinuria, and that's the best thing for patients and for all the treatments in the IGA space.

Speaker 2

Well, this has been fantastic. I think it's still the very early days of this launch, and it's been growing fantastic, and so both, I think, for IGAN as well as FSBS. So really excited about what's next to come with with the pipeline and with the continued growth from the commercial side We look forward to keeping you posted. Thank you for joining us