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: Maury Raycroft - Jefferies - Analyst
: And maybe starting off with the FILSPARI launch. In your recent first quarter update, you reported that your initial six weeks of launch at 146 new
patient starts, how should we think about the pace of PSFs for April, May, and the upcoming months?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And maybe talk a little bit about the feedback you're getting from nephrologists who are prescribing FILSPARI and any perspective on how
patients are doing on treatment?
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Yeah. It's -- I spent quite some time in the field myself. I think one of the things that you see with FILSPARI, it's a very consistent treatment effect.
It's accually in the label, we have seen that across the different studies, both the DUET Study, the DUPLEX Study, and the PROTECT trial as well. And
this is the time being three months into the launch that you start to hear anecdotal feedback from physicians that have prescribed FILSPARI to
their patients.
Just to give you an example, I was in the field last week, physicians that just have prescribed his first patients with FILSPARI saw the patients back
after one week 200-milligram dose, and that's the starting dose two weeks, normally 200 milligrams then you'll update 300 to 400 million. The
patient was still 200 milligram after one week of treatment, baseline proteinuria level of 1.4. Patient was after one week in full remission 0.3. And
this is the anecdotal feedback that we are now hearing more consistently. You may recall like on the first earnings call, that was just a week after
we had the FILSPARI lunch, the first prescription, I happened to see the physician that had -- was the first prescriber, also here patient and baseline
5 grams per gram rapidly progressing woman in her 30s. And that patients after six weeks came back and the patient had a 1.7 grams per gram
proteinuria level.
The physician call it astounding because this patient had been on all sorts of treatments, ACE inhibitors, ARBs, steroids. calcium urine inhibitors
and patients could not be controlled. And I think this anecdotal feedback is really reinforcing the profile of FILSPARI. There's so much we can do
with our commercial presence. But I think the real, the personal experience that we are hearing about right now, I think is the best advocate for
the drug and very consistent to the profile how it's being described in the label as well.
Question: Maury Raycroft - Jefferies - Analyst
: Got it. That's helpful. And would Tarpeyo also approved it on the market, how is that impacting your launch in any perspective on how those drugs
are used?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. Okay. And we did a survey late last year to gauge the level of awareness of potential use and approximately 80% of prescribers were familiar
with FILSPARI. So I'm wondering if you're seeing something similar in your real-world experience, how much education efforts do you think will
be needed to gain traction based on first few months since launch?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And you've got the REMS program and the label, there's been discussion around that. What's been the physician and patient receptivity to
REMS? And what are your latest offset?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And how should we think about stocking dynamics in second quarter and beyond? And what are your revenue expectations for second
quarter and for the balance of the rest of the year?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. Okay. And let's see, wanted to dig into launch metrics a little bit. Just wondering if you're seeing more PSFs in academic or community
centers. And what is the conversion rate then? And are there any bottlenecks [they want]?
Question: Maury Raycroft - Jefferies - Analyst
: As far as the conversion rate and just any bottlenecks?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. Okay. And going back to Tarpeyo, it may be too early to tell, but what are dynamics you're seeing as it relates to switches from prior treatments,
including our Tarpeyo [treat] patients?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. Okay. And for your IgANs two-year eGFR data expected in fourth quarter this year, presumably you had some insight into nine-month blinded
data, and we know that FDA was aligned with accelerated approval based on the data. Is there anything you can say about IgAN-blinded eGFR
data from the ongoing PROTECT study to give investors confidence that the fourth quarter data will play out as predicted?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. That's helpful. And you spent some time analyzing your FSGS data. In light of that, do you have a better sense of what may be happening
with the irbesartan arm performance in IgA nephropathy? And do you expect similar or different irbesartanic trends in IgAN versus FSGS?
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JUNE 07, 2023 / 3:00PM, TVTX.OQ - Travere Therapeutics Inc at Jefferies Healthcare Conference
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And maybe going back to REMS for the label, you mentioned having the first conversation with FDA on getting REMS removed after you
get the two-year IgAN data, is that still the plan? And would that be as you're filing the sNDA or after you get the full approval?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And maybe digging into protect a little bit more. If you just walk us through the importance of proteinuria in IgA nephropathy. Why you
believe regulators are willing to approve medicines based on proteinuria and what would be clinically meaningful for corresponding eGFR benefit?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And for some of those, the Inker paper and other references out there, I guess what are the values that are meaningful?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. Okay. And there's obviously a lot of data coming up in the near term for the IgAN development space. How do you see the competitive field
lining up and the role that you expect for FILSPARI will start to play in the near and long term?
Question: Maury Raycroft - Jefferies - Analyst
: Got it.
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JUNE 07, 2023 / 3:00PM, TVTX.OQ - Travere Therapeutics Inc at Jefferies Healthcare Conference
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And for FSGS, can you talk more about next steps in respect to a conversation with FDA? And what timing if you could look like for that
meeting in public update?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And maybe three quick questions. Do you have any insight as to why despite achieving the 50% reduction in proteinuria, you didn't see
greater benefit on eGFR? And then if you look deeper at the data in patient populations where the study arms balance? And then are you providing
any more specifics on FSGS subpopulations you could pursue where you're seeing greater efficacy?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. And we're pretty much out of time, but definitely want to talk about Pegtibatinase in HCU. You guys have had a couple of updates there
and you're going to start the Phase 3 study by the end of this year. Maybe talk a little bit about that program and set it up for investors.
Question: Maury Raycroft - Jefferies - Analyst
: Great. So in closing, maybe just highlight key catalysts ahead that investors should be focused on.
Question: Maury Raycroft - Jefferies - Analyst
: Great. Thanks, Eric. Thanks, Peter. Thanks for joining us.
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