Good morning, and welcome to the Travere Therapeutics' Third Quarter 2024 Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the conference call over Nivi Nehra, Vice President of Corporate Communications and Investor Relations. Please go ahead, ma'am.

Thank you, Sherley. Good afternoon, and welcome to Travere Therapeutics third quarter 2024 financial results and corporate update call. Thank you all for joining. Today's call will be led by our President and Chief Executive Officer, Dr. Eric Dube. Eric will be joined in the prepared remarks by Dr. Jula Inrig, our Chief Medical Officer; Peter Heerma, our Chief Commercial Officer; and Chris Cline, our Chief Financial Officer. Dr. Bill Rote, Senior Vice President of Research and Development will join us to the Q&A session. Before we begin, I'd like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, performance and achievements to differ materially from those expressed or implied by the statements. Please see the forward-looking statement disclaimer on the company's press release issued earlier today, as well as the Risk Factors section in our Forms 10-Q and 10-K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, October 31, 2024, and Travere specifically disclaims any obligation to update such statements to reflect future information, events or circumstances. With that, let me now turn the call over to Eric.

Thank you, Nivi, and good morning, everyone. Our team has delivered another exceptional quarter, advancing our leadership position in rare nephrology with the full approval of FILSPARI for IgA nephropathy and the ongoing commercial launch. As you will hear shortly from Peter, our commercial team's execution resulted in continued strength in demand, more than 30% growth in net sales over last quarter and a recent acceleration in new patient start forms following full approval and the draft KDIGO guidelines. Our vision for FILSPARI to become foundational care in IgAN is clear and we are making great progress towards achieving this. As we look ahead, there are tangible growth drivers that we believe will enable us to reach significantly more patients with IgAN. These include the full approval label which now provides the ability to educate the nephrology community on the incredibly strong two-year data. The updated draft KDIGO guidelines which should drive nephrologists to treat more ambitiously and use FILSPARI as foundational care and the growing body of data providing further support for earlier treatment with FILSPARI and paving the way for use in combination with other medicines. I'm pleased to share with you, we also recently submitted an sNDA to modify the frequency of liver monitoring in the REMS. If this modification is approved, it represents another step forward in improving access for patients as it would align their liver monitoring with regular schedule of lab work while maintaining patient safety as a key priority. Moving beyond IgAN, the recent recommendations of the PARASOL group offer new hope to the FSGS community. As a reminder, there are currently no medicines approved and few in development for this progressive rare kidney disease. Specifically, we were very pleased that this group of experts, including representatives from FDA, aligned around a potential…

Thank you, Eric. I'm pleased to provide a medical perspective following the full approval of FILSPARI and the increasing confidence we hear from nephrologists about FILSPARI's role as a foundational treatment for patients with IgA nephropathy. This confidence is rooted in FILSPARI 's compelling clinical profile as the only kidney targeted medicine which blocks two pathologic processes, endothelin-1 and angiotensin II. These two pathways work together to amplify inflammation and kidney injury in IgA nephropathy. Our growing scientific evidence demonstrates that FILSPARI, as the only dual endothelin and angiotensin receptor antagonist, significantly reduces proteinuria and preserves kidney function for patients with IgA nephropathy. We just attended ASN Kidney Week in San Diego, the largest worldwide gathering of nephrologists. During Kidney Week, we presented important new data supporting the use of FILSPARI in a broad population of IgA nephropathy patients at risk of disease progression, data supporting the use of FILSPARI early in treatment, as well as early data paving the way for potential combination use with other medications. I'll briefly highlight some of these datasets. First is the SPARTAN study of newly diagnosed RAS inhibitor naive patients with IgA nephropathy, which showed that FILSPARI reduced proteinuria up to nearly 70%, with approximately 60% of patients in the study achieving complete remission through 24 weeks. And eGFR was stable throughout the measurement period. Also, as part of SPARTAN, we examined initial human mechanistic data which demonstrates that FILSPARI reduces an important inflammatory biomarker called Urinary CD163. This biomarker is recognized as highly predictive of IgAN disease progression. The magnitude of CD163 reduction that was seen with FILSPARI has only previously been seen with a systemic immunosuppressive. These clinical data are consistent with our preclinical models and support the kidney targeted anti-inflammatory mechanism of FILSPARI. They're also promising given FILSPARI is the…

Thank you, Jula, and good morning, everyone. During the third quarter we continued our strong and focused launch execution of FILSPARI for IgA nephropathy while also preparing to build upon our success with full approval and to draft KDIGO guidelines. And I couldn't be more pleased with the strong results driven by our talented and dedicated teams. From a demand perspective, we continued our strong growth trajectory and again added more than 500 new patients thought forms during the third quarter. This is particularly noteworthy given that we encountered some seasonality as is typical during the summer holidays, as well as the fact that we took our field force out of the field for an entire week to train them on the new label after full approval on September 5th. And I'm very encouraged with the upward inflection in new patient thought forms in the weeks following full approval. As we highlighted prior to approval, we anticipated that demand would increase as physician prescribed FILSPARI to more of their patients and new physicians will write prescriptions for the first time. And we are seeing clear evidence of this coming through which provides added confidence to our outlook. We also demonstrated continuing efficiencies in our fulfillment process while maintaining high patient compliance and persistency rates. This has resulted in $35.6 million in net product sales of FILSPARI in the third quarter representing more than a 30% gross quarter-over-quarter growth. With our execution, we continue to outperform the most recent rare nephrology launches prior to FILSPARI on all core launch metrics and we are on track to outperform these benchmarks on net revenue in the first full year of launch. We are even more excited about the opportunity ahead of us. As I outlined during our IgAN full approval call last month,…

Thank you, Peter, and good morning. During the third quarter our execution led to a significant increase in net product sales and disciplined investments in the areas we believe will drive growth. Net product sales for the third quarter of 2024 grew to $61 million, compared to $33.9 million for the same period in 2023. This increase of approximately 80% is attributable to strong performance in the ongoing U.S. launch of FILSPARI and IgA nephropathy. During the quarter, we also recognized $1.9 million of license and collaboration revenue which results in $62.9 million in total revenue reported for the period compared to $37.1 million in the same period in 2023. Research and development expenses for the third quarter of 2024 were $51.7 million compared to $60.6 million for the same period in 2023. On a non-GAAP adjusted basis, R&D expenses were $48.4 million for the third quarter '24 compared to 53.8 million for the same period in 2023. Selling general and administrative expenses for the third quarter of 2024 were $65.6 million compared to $67.8 million for the same period in 2023. On a non-GAAP adjusted basis, SG&A expenses were $49.7 million for the third quarter of 2024 compared to $51.8 million for the same period in 2023. The decline in year-over-year operating expenses is attributable to the restructuring enacted at the end of 2023 and reduce clinical expenses as the sparsentan Phase 3 studies advance towards completion. Importantly, we continue to invest in evidence generation to support FILSPARI and IgA nephropathy and potentially FSGS as well as continue to invest in commercial efforts in IgA nephropathy. Now with full approval and draft KDIGO guidelines in hand. Total other income net for the third quarter of 2024 was $1.3 million compared to $3.4 million in the same period in 2023.…

Thank you, Chris. I could not be prouder of the execution and performance of our organization. The underlying dynamics of our FILSPARI launch are strong and have created positive momentum for growth moving forward as a foundational therapy in IgAN. As our near-term opportunities for growth in 2025 and beyond hold great promise for the rare kidney community. Now let me turn the call over to Nivi for Q&A. Nivi?

Thank you, Eric. Operator, we can now open up the line for Q&A.

Thank you. [Operator Instructions]. Our first question is coming from the line of Joseph Schwartz with Leerink Partners. Your line's open.

Great. Good morning everyone. This is Will on for Joe today. Thanks for taking our question and congrats on the great quarter here. So just one for us on PSF metrics. We saw that very minor dip in numbers between the second and third quarter. And as Peter mentioned, it seems like this could be chalked up to summer seasonality and taking the sales horse out for a week in September. But are there other dynamics here that we should appreciate? And how have things been trending now early in the fourth quarter? Any additional color here would be helpful. Thank you.

Thanks Will. Well, let me first say that I am incredibly impressed with what we've seen and I'll ask Peter to talk about the dynamics, particularly what we've seen since full approval. Peter?

Yes, thanks Eric, and thanks Will for the question. Let me start to say that I'm really pleased how we have continued our growth trajectory during the accelerated approval period and how we have outperformed recent rare nephrology benchmarks. To the point in what I mentioned in the prepared remarks. In Q3 we saw some typical summer seasonality and we also took the teams out of the field for a week for training for full approval. So I'm actually really pleased with a continuation of strong growth over 500 patient start forums. But I'm mostly excited about the opportunity ahead of us and how we will accelerate momentum based on the full approval. And to what I said in the prepared remark, the demand uptake we are seeing in the first month after full approval is really encouraging and allows us to end the year strongly.

Great. Thank you so much.

Our next question is from the line of Vamil Divan with Guggenheim Securities. Your line is open.

Hi, it's [Sarseni] for Vamil. Congrats on all your progress and thank you for taking our questions. In regard to PARASOL recommendations and FSGS, how much do you feel the discussions with the FDA will focus on hitting specific pretenurious thresholds at certain time points? And perhaps reanalyzing the data that way versus considering the totality of data more holistically and focusing more on the mechanistic channel and the biological possibility arguments?

Great. Thank you so much for the question. Bill, I'll turn that over to you.

Yes, thank you for the question and I think it's a good one. I think you hit on the elements of what's important. Certainly based on PARASOL, the agency has said publicly that proteinuria can be used as a validated surrogate for full approval in FSGS, but the agency will always look at the full data in the submission. So totality is important in parallel with hitting proteinuria targets. And I think additionally, as you noted, the biologic plausibility is key to the entire story, that your reduction in proteinuria in the case of Sparsentan is due to the biology and the pathology of FSGS. It's a podocyte driven disease and the only way you can reduce proteinuria is to make that cell healthier and Sparsentan achieves that. We have clinical data, we have preclinical data that support that. So all-in-all, you hit on three very key elements of this mission and I, I don't know how they will weight them, but we're confident that we have very strong data across that whole space.

Yes. Thank you, Bill. The only thing that I would add is that's the opportunity that we have to speak with Evan and why we're eager to meet with them here soon to be able to understand what specifically information do they want. That said, as we take a step back, we're very confident in the data that we generated in our programs.

Thank you. I'll get back in the queue. Thank you.

Thank you.

Our next question is coming from the line of Anupam Rama with JPMorgan. Your line is open.

Hi guys, thanks so much for taking the question and congrats on all the progress at ASN and in the quarter. Can you give us a sense of the scope of the additional data you've provided on liver monitoring sort of beyond the clinical experience? I'm assuming that package includes all of the data from FSGS and again, clinical trial work, but correct me if I'm wrong there? Thanks so much.

Thanks so much, Anupam. So, Bill, why don't you take that question as well?

Yes, thanks for the question. It does. Your supposition is accurate. We pulled the data from the ongoing clinical trials, the open label extensions for both DUET, DUPLEX and PROTECT. So that's an increasing body of data as well as the data that we're gaining from all of the commercial experience. So we have a substantial body of data and all of that was pooled. Importantly, what we've seen is in both the trial extensions as well as in the real world, the commercial experience, we see the same thing that we saw in the trials that low levels of LFT elevation and no evidence of Hy's Law, or liver failure events or liver injury. So having that consistent story with a much larger body of evidence was the basis on which we built our submission to go back and change the REMS frequency to match that that hits the cadence that patients see their nephrologist on a quarterly basis.

Thanks so much for taking our question.

Thank you.

Our next question is coming from the line of Tyler Van Buren with TD Cowen. Your line is open.

Hi there. Thanks for taking my question. This is Greg Wiesner on for Tyler from TD Cowen. I'm curious to get some insight on what you will propose during the Type C meeting and what are the key questions you would need to ask of the FDA? Thank you.

Great. Thanks so much for the question, Greg. Bill, back to you.

Yes. Well, I think we leverage the discussions that have been had at PARASOL where the agency has suggested a threshold of proteinuria reduction so that you have a treatment effect for both the control and the treatment arm. Sparsentan versus irbesartan in our case, they haven't suggested or they haven't nailed down a specific endpoint. What they've said is you need to make a proposal and come in and talk to us. But with their presentation, they have spoken the most about the value of 0.7 gram per gram per day, patients that get below that. So, they think that's a reasonable spot to think about when you picture what will go in and propose to the agency. And the question really is, you know, here's our proposal, here's how we're going to analyze the data. What else do you need to see in the submission so that we're aligned with the agency and we make sure our filing has everything in it that they need for their review.

Okay, great. Thank you. Very helpful and congrats on a successful quarter.

Thanks, Greg.

The next question is coming from the line of Maurie Raycroft with Jefferies. Your line is open.

Hi, good morning. This is Farzin on from Maurie. Congrats on the progress as well. Following up on the FSGS Type C meeting, are you going to include any data from the open level extension? And then do you also on the post hoc analysis, like what would be considered like sufficient? Like is the pre specified data already good enough or any post hoc work would be needed?

Okay, thanks so much, Farzin for the question. Bill?

Yes. Well the short answer for the open label extension data is yes. That will be included from both the ongoing DUET, Open Label as well as DUPLEX from both studies. As far as post-hoc analysis, we have threshold proteinuria cut points that were pre specified and we looked at those as part of the statistical analysis plan and looked at in addition to FPRE or the modified partial remission, we looked at 1.5 gram per gram, 1.5 and 0.3. So that brackets around the target that the agency has seemed to align around. We're not doing a lot of post-hoc analysis ahead of that meeting. So we will go in with the data that we have and work with them on what additional analyses they want to see in that submission and get that aligned so that we have in the file everything they need to complete their review.

Yes, thank you Bill. And I'll point you all to our corporate presentation which is posted on our website. If you look at Slide 29, you can see very nicely laid out the treatment effect across those different pre specified thresholds, clearly showing a benefit and superiority for Sparsentan over irbesartan and FSGS. Thanks Bill.

Thank you.

Thanks, Farzin.

The next question is coming from Greg Harrison with Scotiabank. Your line is open.

Good morning everyone and congrats on the quarter. This is Joe Thomas on for Greg, just one kind of on the patient and physician education front, can you maybe comment on any ongoing efforts or opportunities you might have to help patients be getting diagnosed earlier and treated earlier based on the recent KDIGO draft guideline update? Thank you.

Thanks, Joe. Peter?

Yes, I think the presentation that Jula mentioned earlier in the prepared remarks tells about the benefit that FILSPARI has also with patients with lower proteinuria levels. And I think what I'm hearing from physicians, especially coming back from ASM, where we had many conversations with thought leaders as well as community physicians, is there is like a higher urgency and a call to action to treat patients earlier and more aggressively. And I think KDIGO really helps there. And I think we have the data now also in hand to show that FILSPARI acts consistently across different patient populations.

Thank you. Thanks, Peter.

Our next question is coming from Jason Zymansky with Bank of America. Your line is open.

Hi, good morning. This is Dina Ramadan on for Jason Zymansky, Congrats on the progress this quarter and thank you for taking our question. Though it might be a little bit too premature to speak to FILSPARI's upside in FSGs. Could you discuss what the broader opportunity might look like? Is this something you anticipate needing to build the market, or do you think dynamics are likely to quickly shift? And maybe what sort of challenges is a new entrepreneur likely to face given the lack of approved therapies, especially given the potential shift in trial endpoints? Thank you.

Thanks, Dana, for the question. Peter why don't I turn that over to you and then Jula, if there's anything further that you'd like to add on how physicians are thinking about FSGS. Peter?

Yes, thanks, Dina. Well, we are really excited about the opportunity for FSGS. In the U.S. in particular, the market may be slightly smaller than IgA nephropathy. We anticipate about 15 to 30,000 patients as directly addressable for FILSPARI. But to the point you're making, this is a patient population that is served by basically the same prescriber group as we have for IgA nephropathy. So it's basically the same call point. And if we would get like a full approval, I am expecting that we will have a rapid uptake since the brand name of FILSPARI is so well established as well as the clinical profile. And many of the physicians have already the experience with FILSPARI in IgA nephropathy and they have seen the rapid and sustained proteinuria benefit in their patients. So I think the opportunity is real and we are really excited about it. And as I said, we have a strong position that we can build upon.

And let me just add that remember, well, FSGS is a patient population with a really high unmet need. They have symptomatic disease, they might wake up one day, be very swollen and there's really almost nothing that is effective and safe for these patients. They get treated with immunosuppressants and if they have genetic disease that doesn't work for them. So there is a high unmet need particularly for non-immunosuppressive therapy that can reduce their proteinuria and help their symptomatology as well. So to Peter's point, it meets the same physicians who are treating IgAN and FSGS. So we do believe that there is a significant unmet need here that we can address with FILSPARI.

Dina, thanks so much for the question. And certainly we recognize that there's additional education and outreach but as, as you would have heard from Julie and Peter, there's a high recognition and certainly brand awareness. We expect to be first if approved and certainly the leader and the new standard of care within FSGS. So more to come there, but certainly a tremendous opportunity for us to serve this community.

Appreciate all the color. Thank you.

Our next question is coming from Laura Chico with Wedbush Securities. Your line is open.

Good morning. Thanks very much for taking the question. I had one on FSGS. There was some commentary at the PARASOL meeting earlier this month and just coming out of ASN now, I'm wondering if you have any thoughts on whether groups like KDIGO would consider making an update to FSGS treatment guidelines in response to the observational data that PARASOL presented. Thanks very much.

Thanks, Laura. Jula, I'll turn that one over to you.

Well, it's certainly potential. They typically do update if there's new treatment or there's change in where we want to target the thresholds for. There was just recently an update to those guidelines, but I would anticipate if we get full approval for Sparsentan and FSGS, then that would be an appropriate time for them to make an update.

Thanks very much.

Thanks, Laura.

Our next question is coming from Yigal Nakamovich with Citi. Your line is open.

Hi, this is Rena on Yigal. Thanks for taking my question. I just wanted to ask if you could comment on any compliance or adherence metrics for FILSPARI with regard to the monthly REMS monitoring, and how you might expect this rate of compliance to change with the reduction in frequency for deliver monitoring?

Thank you, Rena. Peter, I'll turn that over to you.

Yes, thanks for the question. What we are seeing is that the compliance as well as the persistency rates of FILSPARI are really high. And I think that speaks to that patient's experience that this product works for them. This is a patient population that historically has seen very little innovation. Many of the patients, every time they see their physicians, they hear you're not yet to the targets. And for the first time with FILSPARI, they are actually reaching targets. And some of those patients are in full remission, which is really encouraging for patients. And I think that's also the explanation for the high compliance and the persistency rates.

We would expect certainly that with not just the lab values but also the support and the education that these patients have, including as part of the REMs. We'd be very thoughtful around if there is a modification to less frequent monitoring that we would ensure that these patients still have the right level of support and engagement from us and from their clinicians.

Thanks for taking my question. Congrats on the quarter.

Thanks.

Our next question is coming from Mohit Bansal with Wells Fargo. Your line is open.

Hi, this is Sadia Rahman on for Mohit. Thanks for taking our question. So a question on the IgAN launch, given the KDIGO update recommending lower targeted proteinuria levels. Wondering if you're seeing that payers are willing to reimburse for patients that start below 1 gram. Given that your trial enrolled patients that were above that, has there been any resistance there from payers? Thank you.

Thanks for the question, Peter. I'll turn that over to you. And might also be helpful to talk about how these patients are at risk based on the radar data to frame. Peter, go ahead.

Yes, maybe Eric, to the last point, maybe it's good to start at like patients. According to the radar registry data set, patients reach even 0.5 gram per gram of proteinuria There is still like a 22% chance that they progress to dialysis or kidney failure by within 10 years. So this is a progressive disease. Payers are also recognizing the progressive nature of the disease and we have invested quite a bit in education for payers as well on this aspect. On your specific question with regards to like how quickly are payers adopting new guidelines as well as our new label? Well, we have an active accounting that is focusing on this. I'm really pleased with the progress we are making with payers. Some of the authorization criteria are already being updated but the majority, that's the reality is early in the year, early in 2025. But we're seeing good uptake and we also start to see that patients with lower proteinuria levels are being treated with FILSPARI.

Great, thank you.

Thank you.

Our next question is coming from Alex Thompson with Stifel. Your line is open.

Hi, this is [Charles Njai] on for Alex. Thanks for taking our question and congrats on all the progress this quarter. I guess from our end just wanted to ask about your current expectations for [LOE] in IgAN and how you see those changing in the near future?

Sure. Thanks Charles for the question. So our current planning assumption for LOE with sparsentan is into 2033. We were very pleased to announce that we have an additional term for orphan drug exclusivity that was associated with the full approval in IgAN that would take us to September 31st. Sorry, September of 2031. So we are very pleased to have both of those layers of protection. But our current base assumption is into 2033.

Thank you.

Thank you.

Our next question is coming from Vamil Divan with Guggenheim Securities. Your line is open.

Thank you. Sarseni on for Vamil. In regards to FILSPARI's IgAN launch, could you comment on your feel for the update with community based mythologists versus academic thought leaders now versus when you first launched? In other words, do you feel that your message is getting out to a broader group of mythologists now?

Sarseni, thanks for the question, Peter. I'll turn that over to you.

Let me rephrase the question. I think the question is like what is the update that you're seeing with thought leaders, academia, relatives to the community, physicians. So what we have here is and I think it's good to -- go ahead.

Essentially how that changed now under full approval versus when you first launched.

Yes, I would say it's early days. I mean we are now 4 or 5 weeks post full approval. But I can give you like a broader sense on how uptake has been for FILSPARI so far. And I think it's good to realize also that you have to get a broad net to reach all the patients. And what we have said is we are planning to reach about 6,000 nephrologists out of the community, out of an universe of about 10,000 nephrologists in the U.S. to be able to get to about 85% of the patient population. So the majority of those patients are residing in the community. And that's what we also see in the prescription patterns that the majority comes from the community. Having said that, I'm really encouraged with the strong feedback that we get from academia and partly this about the profile of FILSPARI and in particular where FILSPARI is being positioned. I think the recent KDIGO guidelines really outlining that you have to target the kidney as well as the immune system really resonates with physician. And what I'm hearing is that physicians really feel that FILSPARI is well positioned to be that foundational care targeting the kidney with a broad utility for a broad patient population. So hopefully that answers your question.

Yes. Thank you.

Ladies and gentlemen, this concludes the question and answer session of today's conference call. I'll now hand the call back over to Nivi.

Thank you, everyone, for joining us for our third quarter 2024 financial results call. We look forward to providing additional updates on our progress. Have a great rest of your day.