The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Tyler Van Buren - TD Cowen - Analyst
: Congratulations on the progress.
Can you just elaborate on any interactions with the Agency you've had since you filed the sNDA for FSGS and how those have gone? And is the
FDA feedback that's been publicized by competitor Dimerix consistent with your experience with the Agency?
Question: Vamil Davin - Guggenheim Partners, LLC - Analyst
: If I just have one question, I'll keep it on the FSGS side. And just, again, tied to the regulatory discussions and the label, you mentioned the data is
supportive across a broad range of patients with FSGS.
Might be a little bit early for you to comment on this but I'm just trying to get a sense of what you think the label would look like if they would just
be literally for all patients with FSGS? Or do you think there might be some restrictions in how the indication is defined?
Question: Will Soghikian - Leerink Partners LLC - Analyst
: This is Will, on for Joe. Congrats on the strong quarter and progress here.
One from us. With the recent approval or accelerated approval of Novartis' second therapy in IgAN, could you provide a bit more color on what
your sales reps are seeing in the field? Is there some counter detailing that's ongoing? And what are the main types of questions your reps are
getting?
And then, maybe, piggybacking off of this, it seems like the nephrologists' more extensive experience with FILSPARI, combined with the eGFR data
on the label, might make it a preferred choice for a new patient. Is that something you're seeing in the field? Or is it a bit early to tell?
Question: Anupam Rama - JPMorgan Chase & Co. - Analyst
: I was wondering if you could expand a little bit on your gross-to-net comments in your opening remarks, maybe, helping us understand the type
of impact you saw in 1Q and give us a little color, here, about -- if looking to the balance of the year, gross-to-net is actually a tailwind, with the
reversal of the impact that you saw in 1Q?
Question: Laura Chico - Wedbush Securities Inc. - Analyst
: One question for you on the cadence of patient start forms. It was interesting to see the number tick up a little bit over the prior quarter.
Eric, I think you had made some comments, prior to this, about expectations around, maybe, the rate of growth here. So just wondering if you can
have any comments or thoughts on the sustainability of this metric and where this might go over the course of 2025.
Question: Liisa Bayko - Evercore ISI - Analyst
: Just a couple for me. I was wondering if you could just break out -- I know you talked about this a little bit but what percentage of prescriptions
are you seeing that are below 1.5 grams now that you have label expansion versus above 1.5 gram?
And then, are you seeing any change in new patient adds now that we have atrasentan? I mean, in some ways, having another player there can
grow the market and grow awareness. In some cases, you see new patient adds stabilize or even drop off a little bit. I'm just wondering what early
trends you're seeing there.
I think that's it for me.
Question: Gregory Harrison - The Bank of Nova Scotia - Analyst
: Wondering about your assessment of the impact that the removal of the REMS program could have on the trajectory of new patient starts in IgAN.
Is it, maybe, on the level of the inflection you saw, since you were granted full approval, compared to the period before that?
Just trying to get a sense of the additional patient flow that you may see, if that's granted.
Question: Sadia Rahman - Wells Fargo Securities, LLC - Analyst
: This is Sadia Rahman, on for Mohit.
I have a question on FSGS on the Dimerix. Recently, there was a partnership announced for US commercialization of that asset. How are you thinking
about the benefit of that drug versus sparsentan and FSGS? And do you think they could still be significantly further behind from launching in the
US, based on their enrollment status and how long it took for DUPLEX to enroll?
Question: Maury Raycroft - Jefferies Group LLC - Analyst
: I'm wondering, just for FILSPARI and IgAN, what the split is between new versus repeat prescribers? And can you provide more granularity on what
you're seeing on compliance and persistence rates? What's the average amount of time that patients are staying on treatment?
Question: Prakhar Agrawal - Cantor Fitzgerald & Co., Inc. - Analyst
: Congrats on the quarter.
On the FSGS and the expectations for the launch, I just wanted to get some color there. Among the 15,000 to 30,000 addressable patients for FSGS
in the US, how many of these are currently managed by FILSPARI top prescribers?
And any thoughts on how you expect the launch to be ,when approved?
And if I can just follow up here, on the payer discussions on FSGS pricing, wondering if you got any feedback there, given the possibility of double
the IgAN pricing and whether that's feasible here?
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MAY 01, 2025 / 8:30PM, TVTX.OQ - Q1 2025 Travere Therapeutics Inc Earnings Call
Question: Jason Zemansky - BofA Securities, Inc. - Analyst
: Congratulations on the progress.
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MAY 01, 2025 / 8:30PM, TVTX.OQ - Q1 2025 Travere Therapeutics Inc Earnings Call
I wanted to ask a follow-up regarding some of your earlier ,comments regarding dynamics, as far as the updated KDIGO guidelines go. But do you
have a sense of what overall fraction of the community has started to embrace treating more aggressively? Is it, overall, meaningful? Should we
expect a significant inflection when these are finalized? Or is it going to be something more, like, a trickle effect, thereafter?
Just trying to get a gauge of near-term impact of the different growth levers.
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