So I wanna introduce the Travere team that's here. This is Chris Cline, who is CFO, and Peter Heerma, who is, your chief—Well, you're head of commercial. I don't know what you- Chief Commercial Officer. This is, you know, on my end, meant to be interactive, so if you do have any questions, just raise your hand, and we'll have you take them. But I think let's just start off with maybe a brief overview of Travere, just to get everyone on the same page. Sure, I'm happy to kick it off. Thanks, Lisa and Evercore, for having us here today. It's great to be down here. Peter and I will be making some forward-looking statements, so please make sure you look at any of our full disclosures on our Forms 10-Q and 10-K. For anybody new to Travere, we are exclusively focused on identifying, developing, and delivering life-changing therapies for people living with rare diseases. At the core of our focus is our pipeline, which is really focused on delivering new treatments for rare kidney and rare metabolic diseases. We've had a very busy year, a very exciting year, which was led by our lead program, FILSPARI or sparsentan, with the first approval in our pipeline in February of this year, and FILSPARI gained accelerated approval for the treatment of proteinuria and IgA nephropathy. Peter will be able to go into a bit more detail on the launch and how we're progressing there, but overall, we're very pleased with the foundation that we've been setting for FILSPARI to become a new treatment standard in IgA in the future. Additionally, we generated two datasets for two-year data for both FILSPARI and IgA nephropathy and FSGS, and with both of those datasets, FILSPARI has shown the ability to reduce proteinuria and demonstrate the ability to preserve kidney function long term. Also very important, generally safe and well-tolerated and enabled to accrue benefit over time for two years. So, very exciting datasets for those two, and we're in the midst of regulatory interactions that we are on track to provide updates on before year-end. So more to come there from FILSPARI here in the near future. Also in our pipeline is pegtibatinase, which is the PEGylated enzyme replacement therapy for the treatment of classical homocystinuria, or HCU, and we're very excited about this program because it has the potential to be the only disease-modifying therapy for HCU in an area where there's a significant unmet need. And there, we're expecting to initiate a phase III later this year, so very exciting for the pipeline overall. Overall, from a financial perspective, we have a very strong financial foundation, with $635 million at the end of last quarter on the balance sheet, and very excited about where we're headed here in the future. Great. Well, the ASN meeting just wrapped up, and so I thought, maybe you could give us your perspectives on kind of what the key learnings were from your end. You have two diseases that are relevant for you there, both IgAN and FSGS, so. Yeah, happy to take that one, Lisa. Well, first of all, I thought it was a very exciting ASN with regards to glomerular disease, which was really, like, the core of the conference, in particular, IgA nephropathy. I think within IgA nephropathy, Travere and FILSPARI were the most present, according to external research. We had the first two late-breaking sessions with simultaneous publications in The Lancet and the New England Journal of Medicine. Chris was talking about that. It's the two-year data, the two-year confirmatory data in both IgA nephropathy, as well as FSGS. We also had data in treatment-naive patients, patients that had not been treated with ACE and ARBs, where we saw, like, a tremendous proteinuria benefit of 80% after nine months of treatment. And we had the first data in combination with SGLT2 as well. So I think overall, really, well-received. It was the first time we were there with FILSPARI, that it was branded. We had a strong booth, very... A lot of interest, and I couldn't be more pleased. Been 25 years in the industry, I never had, like, two late-breaking sessions with simultaneous publications in the most respected journals. So yeah, exciting. Right. One thing that really struck me from the meeting was some of the data around the B-cell modulators, and it looked like, you know, there was really a big, a big, I think, leap, 'cause this is the second time we've seen, you know, from now a more robust dataset, perhaps, that you get a kind of stabilization of eGFR, it looks like, at least with two of the B-cell modulators so far. So just curious on, you know, to kind of... Do you agree with that? And as you think about that, where do you think of your positioning within the IgA nephropathy market, if in fact this does play out to be the case? Yeah. Well, first of all, I think it's good, and it also speaks to the excitement in IgA nephropathy because you have different modalities that are targeting different pathways for IgA nephropathy. What we are hearing loud and clear, and I thought that's something also that you heard in the conference, is that FILSPARI, sparsentan, is really seen as, like, a foundational treatment, replacing ACE inhibitors and ARBs. Because sparsentan is inhibiting two pathways, both the ERA pathway as well as angiotensin. Angiotensin receptor inhibitors are now the gold standard. And where nephrologists see FILSPARI play is, like, really replacing ACE and ARBs as that foundational treatment first. If you look at all the the treatments that are being studied, and you talked about, I think, sibeprenlimab, which is an anti-APRIL compound, it acts more higher up in the cascade, but it's always studied on top of ACE inhibitors and ARBs. So I think FILSPARI is really replacing ACE inhibitors and ARBs, and other modalities at the different pathways. The study that you were referring to, I think, is exciting, but you also have to realize it was 144 patients, four treatment arms, so 36 patients per arm, 12 months. Exciting, but I mentioned earlier the sparsentan data in treatment-naive patients. Also, their eGFR was stable with FILSPARI. So I think different treatment options act at a different path, at a different part of the treatment cascade. But I think FILSPARI, as I mentioned, like really foundational, replacing ACE and ARBs, and I think other modalities can be added on top of that. Okay. You've been, I guess you're about nine months, maybe 10 months into the launch thus far. You know, what have you learned about the IgA nephropathy market, if you kind of look back retrospectively? Yeah, it's—I would say, first of all, this is a market in development, and we have to educate the stakeholders, the nephrologists as well. I think historically, when you read, like, publications from, like, five years ago, it was often being described as IgA nephropathy is generally a slowly progressive disease. And with the investment we have been making in registries, and we did the first registry in the U.K., it was 2,500 IgA nephropathy patients, and it's still a rare disease, so a registry of 2,500 patients is actually quite a large registry. Actually showed that this is a much more progressive disease, and that basically all the patients in that registry actually did reach dialysis. That's actually being replicated now in the U.S. as well. The first data was actually also presented at ASN. So I think there is now a recognition that IgA nephropathy is a more progressive disease and should be treated more early, early on, and with more aggressive treatment targets as well. So I think overall, exciting. Okay. So far, is the launch going per your expectations? I mean, it's been... You know, sales have been a little slow, but I think you also said that this would be a launch that would be kind of slow and steady. And as we kind of go into 2024, you know, what kind of, in your, like, kind of purview, do you is out there that might kind of provide a boost of sales, and when are you expecting things to really kind of ramp up? Yeah, it's a great question. I think overall, I'm very pleased with the progress we have been making. I think, like especially early in the launch, and I've been involved in many product launches in pharmaceuticals, most important is that you generate demand, getting prescriptions, and convince physician that this is the better treatment for their patients, but also that you allow for broad access. And if I look at where we are right now, and the last data that we presented was, like, after 7.5 months, we had about 1,000 patient start forms for FILSPARI. We had, like, very strong uptake also on coverage, on the coverage front. So I think in, like, both, I think, are at the high end what you would expect from a launch. To your point, the revenue, I think, is lacking a little bit. That's also because of the process, and you have to realize patients are getting their ACE and ARBs are being replaced now with FILSPARI. ACE and ARBs, generic medicine, comes from the retail pharmacy. The process with FILSPARI is more higher touch with a specialty pharmacy process, and also having a REMS certification process. So for a subgroup of patients, that process may take a little bit longer because there is an educational component as well. But we see good take-up. We... I think also important in this, this context, is that since it was, FILSPARI was approved through accelerated approval, you have, like, an inability to promote, in the first 120 days, and now we are past that, so now you can do more communication, both to the physician as well as to the patient. That allows for more patient materials, but also for the physician to educate their patients, and we see that that works. We see, like, a strong uptake now in REMS certifications in the first two weeks, and we also see an increase in paid patient shipments. So I think overall, really pleased with the progress. I think the revenue was lacking a little bit, but I think we're making really progress there. What kind of an impact do you expect any kind of inclusion in the guidelines of sparsentan to have? Yeah, I think that's a great question, and I think our publication in The Lancet was very timely because we know that the global guideline committee, it's the KDIGO committee that is updating their guidelines for early next year. Public review is expected early 2024, with, like, the full guideline publication probably in the early second half of next year. I think there are three elements that I think is important. Like, one is, I think there will be more aggressive targets for IgA nephropathy, and I think physicians have now the tools with FILSPARI and some other medicine to be more ambitious in treating those patients to a certain target level. So I think there is an expansion- Right now, the target is one gram per day? Yeah, technically it's one- Okay ... 1 gram per day. Okay. It's the latest KDIGO actually says 0.75 to- Okay ... 1 g per day. I don't know this for sure, so I'm talking on personal title, but I would not be surprised if it goes to 0.5. Okay. That's also in lupus nephritis. I think, many, especially academic nephrologists, that's a target that they're already, targeting in the first place. So I think that allows for a broadening of the, the, the market potential. We, we mentioned from, from the launch that we see the addressable patient population to be about 30,000-50,000 in the U.S. With a more ambitious proteinuria target, that patient population will go up. So I think that's number one. I think the second one is, it, it gives trust, to physicians, and physicians that have been on the fence so far and are more conservative in their prescription pattern. Once it's being, included in the guidelines, I think that may be the trigger point for them to start prescribing. I think that's the second one. And then the third one is from a payer perspective also for, like, formulary certifications, recertification. I think having a guideline that is supporting FILSPARI will help us in, in those payer negotiations as well. Okay. In terms of, you know, kind of the market going forward, you know, we would expect atrasentan to maybe come to market. How are you preparing for that yourselves, and how are you thinking about, you know, whether or not they would have also a REMS requirement? We actually were just Jing and I were talking about that with a client yesterday, back and forth on whether or not they would have the same kind of requirement. So I guess, how are you kind of anticipating all of that, and what are you doing ahead of that? ... Yeah, let me tell you that one. So I think starting with the last part of your question, the REMS process, well, we know that atrasentan will get a REMS, and I'm quite familiar with the program. I used to be responsible for the program at, back in the day at Abbott. We already, we're planning for a REMS. Okay program at that time for Okay fetal toxicity. So I think that is, I think what you- For a different, not for liver. For liver is the second one. Okay. So that's yet to be seen. Okay. We were anticipating that we would have a liver monitoring program. I think the data didn't justify that as well. If you look at the and you saw the confirmatory- Right Two-year data right now, you had five patients with elevated ALT, AST, or transaminases, and you had actually seven with irbesartan, with the control, the active control arm. So I think the data didn't confirm, but hopefully the FDA will recognize that as well at some point. And so we have an opportunity to get rid of the REMS program. For atrasentan, we don't know. I don't think they know as well. I think a very important aspect is, as I mentioned before, FILSPARI acts on two pathways. It's inhibiting both angiotensin as well as the endothelin pathway. Atrasentan is only inhibiting the endothelin pathway, so it's on top of ACE and ARBs, and it's on top of other medicine as well. So SGLT2, for example, is often being used right now. I think pill burden matters for this patient population, but I think there's also an efficacy play. If you have one pill, and you have maximum inhibition of both the endothelin as well as angiotensin, there is an efficacy game to play. I think if it's on top of maximum tolerated ACE and ARBs, we know from the SONAR trial that a substantial part of the patient population actually was not on maximum tolerated ACE or ARB. And so I think there is a there is a price to pay from an efficacy perspective. So more to come. I think most importantly is that we have a two-year window that we commercialize the product, and we're in the market. Once they come, we will have the confirmatory data and and maybe the the confirmatory indication as well. I think we are on a very strong position to be ready for them. Okay. And how... As it pertains to liver tox, like, what is the... I think they have 5,000 patients worth of data, Novartis does for atrasentan. What is the rate at which you would feel comfortable? Like, if you see only a couple of cases in 5,000, is that okay? Like, what is the hurdle for liver tox that we might feel like, "Okay, with 5,000 patients worth of data, you know, they've probably cleared that." Do you guys have a sense of that? Well, I'll hop in on this one. Thanks, Lisa. What I would say is that there isn't a specific threshold necessarily that FDA has pointed to and said: "Look, if you get to X number of cases or X number of patient years, that, you know, we're going to make some change to the label." What we've committed to is really going to FDA at every instance that we can, right? So for example, through the review process for full approval, and in the future, to discuss the full data set, both from IgA nephropathy and PREVAILS, GPS, to really put that plus whatever patient examples or experience we have from the real-world setting and from them to have that discussion. What we've seen thus far is that the liver elevation cases have been comparable to or lower than, as Peter mentioned, to irbesartan, and we haven't seen any instances of liver toxicity or, you know, drug injury or DILI. And so, you know, from that perspective, we feel very confident that FILSPARI is, you know, it's generally safe and well-tolerated and shouldn't have that box warning, but it's gonna take some time to be able to work through that with FDA. And as soon as we have that input from them, then we'll be able to share that. Okay. And just one other question before I move on to your other program. It's always like the other program, but and I do wanted to get to that. But just quickly, back to kind of like, as we think about the future and other therapies coming forward, like the B-cell modulators, you know, are moving forward. There's this notion that maybe they will stabilize eGFR. What other benefits can you demonstrate that by having, you know, FILSPARI and one of these B-cell modulators would be some additional benefit beyond just a B-cell modulator itself? Like, is there some other kind of long-term benefit? Because let's face it, those two drugs together are gonna be relatively expensive. You know, to not force payers to make a trade-off, are there other kind of like clinical benefits, longer term, that you can, you know, demonstrate to really justify you should really be on these two optimized therapies? Well, I think one point I would like to make is the data, the two-year confirmatory data, from the PROTECT study was shown. It, it was the slowest progression in IgA nephropathy in any study so far. Okay. So I think that's an important aspect. I also mentioned in the SPARTAN trial, which is nine-- which we had data at ASM for 9 months, there was-- it was a stable eGFR. So I think the data of, the anti-APRs, are promising, but it's still early days, so I, I wouldn't necessarily say, like, well, they stabilized- That's fair ... eGFR. On top of that, I think, as I mentioned before, it acts on a different part of the pathway. It's more upstream. I think most importantly, once the IgA complex is in the mesangium, it accelerates damage. It upregulates angiotensin and endothelin, and they upregulate each other as well- Okay ... which is an acceleration of damage and an increase in proteinuria. So once the molecule, the complex is in the kidney, that's why you need to act, and that's what- Okay ... FILSPARI is doing. So if you listen to, like, the thought leader at ASM, for the more difficult patients to treat, a combination therapy is probably required, and you wanna act on different paths, on different pathways and different cascades as well. So I think to your question then on like, well, from a payer perspective, it becomes more expensive. It becomes a little more personalized medicine, as what you see in oncology. My last job was in oncology, and I think that's where we are moving more towards with IgA nephropathy as well. I think being a front runner early in the market and create a position, and I think we have a strong position right now in over 100 formularies, including FILSPARI. I think we have a strong position, and then it's like, what is the sequencing? Like, what product do you start with, and where do you end, and what, in addition, do you wanna add on top of that? So I feel we are in a strong position in that context, but we will see what new data will come and what new products may come to the market. Okay, so, two last questions, I can fold them into one. You've got your other program, maybe we can touch upon that, and then maybe just talk about catalysts for 2024 for Travere. Sure. So I'll take that one. So pegtibatinase, our other program in development, we're very excited about. So we had an update from cohort six of our phase I/II study out earlier this year, in which we showed a 67% reduction in total homocysteine levels. And importantly, in that data set, we also saw that one patient had achieved normalization of total homocysteine levels, which is something that we hadn't seen before in our program. And that's especially important because that was at a point in which you know, physicians look to be able to introduce protein back into the diet, which is something that we know is very important to patients. We've heard that consistently through our interactions, and then also in recent FDA guided discussions, where that's been a topic of focus. So we're very excited about that program. We recently completed our end of phase II meeting, and we're on track to initiate the phase III here before year-end. You know, that's something that, you know, as we look to that program, has the potential to be the only disease-modifying therapy in a disease where there's really nothing that is disease modifying, or, you know, patients right now really are struggling to deal with the diet that they're on or the limited efficacy of what's currently available. So, you know, we're very excited about that program. There, you're looking at a U.S. population of 3,500 patients, similar number in Europe, and that's gonna grow, we think, up to 50% over time, and so a very meaningful opportunity there to help patients. And from a Catalyst perspective, Lisa, you know, what I would highlight is we remain on track to provide updates from both our IgA and our FSGS regulatory interactions for the regulatory pathway there for full approval in in IgA and in the pathway for FSGS between now and the end of the year, and so you'll hear more from us on that, and then also that initiation of phase III. And going into next year, I'm very excited to see what Peter and his team will be able to do from an execution standpoint on the FILSPARI launch and continuing to build on that foundation to make it a new treatment standard in the future. Great! Well, thank you so much for joining us today. Really appreciate, and, look forward to, tracking all this great stuff for 2024. Thanks. Thank you.