Travere Therapeutics, Inc. Q3 FY2025 earnings call

IgA Nephropathy - FILSPARI

• Strong commercial execution with $90.9M U.S. net product sales in Q3, up over 155% Y/Y.
• FDA approved modification to FILSPARI REMS program, simplifying care.
• KDIGO guidelines support FILSPARI as foundational nephroprotective therapy.
• Global progress: CSL Vifor expanding access in Europe/U.K., Renalys on track for IgAN top-line data in Q4.

FSGS

• FDA advisory committee not needed for sNDA in FSGS. Pending approval, FILSPARI would be first approved med for FSGS.

Pegtibatinase

• Successfully manufactured first commercial scale batches, positioning for restart of HARMONY study in 2026.

In the third quarter, FILSPARI's U.S. net product sales were $90.9 million, representing a year-over-year increase of over 155%. DILI contributed $22.3 million in U.S. net product sales. License and collaboration revenue totaled $51.7 million, including a $40 million market access milestone from CSL Vifor. FILSPARI's revenue contribution is significant, driving the company's overall financial performance.

Forward-Looking

• Well-positioned to sustain FILSPARI growth in IgA nephropathy.
• Ready to execute rapid launch in FSGS if approved.
• Well-capitalized with $254.5M cash as of 9/30/2025, no near-term need for additional capital to execute core objectives.
• Aim to advance pegtibatinase Phase III study reinitiation in 2026.

Implicit Risks

• Forward-looking statements involve unknown risks and uncertainties that could materially affect actual results.
• Market competition could impact FILSPARI's growth and market share.

Q: Congrats on another strong quarter of execution. With the new label approved in August, can you quantify either qualitatively or quantitatively the early impact of the REMS adjustment? Are you seeing new prescribers or a new patient base that might have been more reluctant previously?

A: Peter Heerma noted consistent demand since full approval, REMS modification positively received by nephrology community, seeing continuation of new prescribers and expansion within experienced prescribers, with REMS change helping patients at higher proteinuria levels.

Q: Any insight into any competitive pressures at all? Or have you not detected any?

A: Peter Heerma stated very consistent demand, Q3 saw less seasonality impact than last year in a more competitive landscape.

Q: With respect to FILSPARI at this point, do you have a sense as to what the typical baseline proteinuria level is at start of prescribing? I think Peter made a comment about perhaps some patients coming in now with a lower level. Second, are you detecting any off-label use in the FSGS setting at this point?

A: Peter Heerma said baseline proteinuria levels are well below 1.5 gram per gram, seeing good inroads in lower proteinuria market segment. Eric Dube mentioned seeing some limited off-label use in FSGS, but not promoting it.

Q: Congrats on the quarter. Just in the context of the beat that you guys had here with FILSPARI, how do we think about sort of the quarter-over-quarter declines in patient start forms? I know you mentioned some summer seasonality, but there were those tailwinds from guidelines and REMS. What are the considerations there? Anything to note on gross to net or inventory?

A: Peter Heerma noted strong demand in Q3, September had strongest daily patient start form generation, trend continued in October, less seasonality impact than last year. Chris Cline mentioned less than $2M benefit from gross to net in Q3, expecting higher gross to net in Q4, guidance around 20% for the year.

Q: What can we expect in terms of communication leading up to the FSGS PDUFA date in January? Is it possible that you'll disclose if and when you're in labeling discussions?

A: Eric Dube stated practice is not to comment on ongoing FDA interactions, entering quiet period approaching PDUFA date, will provide updates on January 13.

Q: I wanted to ask about REMS and KDIGO. I'm just curious, when you're in the field now with the new message around the reduced REMS and the better KDIGO guidelines, how many of the practitioners are sort of aware of these changes or were informed outside of the channels through Travere? Or is it really that the information is coming from Travere in terms of learning about the better REMS and the KDIGO? Just how is that information flowing?

A: Peter Heerma said KDIGO guidelines publication helps trickle down to community nephrologists, our team's educational efforts with physicians, REMS modification communicated by Travere, well-received by physicians as it fits clinical practice.

Q: Then on pegtibatinase, just very quickly, is the scale-up basically a completed project now? Or is there any more work to do to make sure you have enough supply for the whole HCU market?

A: William Rote stated completed first commercial batches, enables engagement with FDA, will continue additional manufacturing campaigns in parallel with study to build stock for launch, key milestone is restarting Phase III study enrollment.

Q: I'm sorry to go back to kind of the net price discussion. But even if I take a couple of million out there for the onetime net price boost, I think the revenue was still a little bit higher than some investors were anticipating based on the PSS trajectory. I'm just curious like is this volume of PSS trajectory that you got, like this quarter and last quarter, which is fairly consistent. Is the revenue growth you're seeing based on that something we should be extrapolating going forward? And like how much is the Q4 gross to net impact?

A: Chris Cline said continued refinement of pull-through process driving revenue growth, third quarter gross to net similar to second quarter, expecting increase in Q4, overall guidance around 20% for the year.

Q: So in FSGS, I think we might see some data from Novartis soon with atrasentan from their basket trial. Can you talk about advantages you see with a dual ERA mechanism in this indication compared with an agent like atrasentan, which doesn't have the RAS inhibitor component, especially this being an indication where there is not as high background use of RAS inhibitors compared with IgAN?

A: Jula Inrig said dual ERA mechanism targets podocytopathy in FSGS with greater nephroprotective potential, FILSPARI shows 50% proteinuria reduction durable out to 2 years, targeting both mechanisms leads to greater reductions in proteinuria and complete remissions in FSGS.

Q: So Novartis during their earnings said that they have 20% NBRx share, 10% of that is coming from Venrefa and the rest is from Fibralta. So maybe if you can expand on where you are seeing Venrefa and Fibralta as gaining share? And then another follow-up on IgAN. You said September was the strongest month, and October you're also seeing good consistent demand. So should we expect the new patient start forms to increase sequentially in 4Q?

A: Peter Heerma said consistent and steadily growing demand since full approval in September last year, launch of atrasentan or iptacopan hasn't changed trajectory, expect demand above 700 quarterly, large opportunity for patients to move from RAS inhibition to dual inhibition. Eric Dube added not providing guidance on sequential increase, but demand above 700 expected.

Q: Congrats on the quarter. You mentioned that your increased SG&A for the third quarter includes additional investment in preparation for a potential FSGS launch. Can you talk more about how you're prepping for the launch and how we should think about SG&A expectations going forward?

A: Peter Heerma said prepping for launch by building upon strength and high brand familiarity in prescriber base, incremental increase in commercial footprint. Chris Cline said SG&A expectations include incremental increase as more sales team members onboarded, with investments continuing for pegtibatinase and other R&D efforts.

Q: I wanted to revisit the efforts to now completely remove the REMS. I guess, first, given the acceleration in patient starts here and therefore, overall exposure to FILSPARI, have your time lines changed at all? And then I guess, any other updates on this front now that the original REMS modification has occurred?

A: William Rote said strategy is 2-step process with frequency change first then removal, process hasn't changed, will continue engaging with FDA on next steps.

Q: Maybe a follow-up on the commentary on some off-label FSGS use. I wonder if you could comment as to whether those patients are coming in at about 2x the IgAN dose or if they're still early in their treatment course and maybe not titrate up fully yet?

A: Eric Dube said limited insight into dosing, important to ensure physicians educated on label and target dose upon approval, patient services support for appropriate dosing.

Q: So first, I want to talk more about the expenses that you mentioned earlier, but to the totality of the expenses going forward. I won't ask you to project profitability timing. But I guess, can you directionally speak to especially R&D going forward as you're going to bringing PEG back into the clinic and how we should sort of view that offset by FILSPARI revenues? Secondly, I'm just curious with regard to Renalys and Chugai, any change in time lines for development of sparsentan in Japan, South Korea and Taiwan?

A: Eric Dube said no change in time lines for sparsentan development with Renalys and Chugai, impressed with their work. Chris Cline said in budgeting process for R&D, expect additional investments for pegtibatinase as clinical operation ramps up, still investments in R&D for other programs like transplant studies, revenue expected to support efforts.