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: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Great. Yes, that's a great overview. Let's maybe start on the FILSPARI launch. You gave the update with your earnings for the first quarter and 146
new patients added. How should we think about that, the pace of new patients being added? And how to kind of gauge what that could be going
forward?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Great. Maybe let's follow up on that a little bit. Could you walk us through the process that patient goes through from the time they see the doctor
until they actually begin taking FILSPARI?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Okay. Great. What feedback are you getting to this point on the REMS process? And how physicians are managing it and even just the general
attitude towards going through the REMS on the part of...
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Yes, I agree. I think that issue has been a little bit overblown. But one of the things I wanted to ask is, as you build more of a safety database with
more and more patients treated, what are the expectations for the future of the REMS, whether it could be removed down the road?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Okay. That's helpful. What other feedback have you received? I know a lot of patients that have been on drug so far. But just any feedback you've
received from patients or physicians? And maybe any anecdotal kind of evidence of the activity of the drug?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Great. That's great to hear. So when we think about the rest of the early launch, what should investors keep in mind when they're trying to project
how it's progressing? And what metrics do you think are most important to really measure the success of the early launch?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Great. Now looking at ex U.S., what are your expectations in Europe, for example, if approved in IgAN? And maybe just if you could talk us a little
bit through your agreement with the partner over there.
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Great. Let's move on to the DUPLEX update. Maybe if you could just walk us through the data we saw there and the benefit you saw on proteinuria
and then the extent to which that translated to eGFR?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Okay. Great. Just one quick follow-up on that. And that's -- when you think about the unmet need there in FSGS and the strong trends in favor of
sparsentan that you saw, what are the potential paths forward in terms of evaluating the totality of the data versus would you be willing to generate
additional clinical data?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Great. Yes. So that brings us to the next point, which is you'll have the update from the PROTECT trial in 4Q, where you'll be looking at eGFR in IgAN
patients. Could you help us set some expectations there for what that data could or should look like? And what would be successful?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Great. Now if the data are positive for PROTECT, how does that help accelerate the launch in IgAN?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Yes. That's helpful. Well, a couple of minutes left, I wanted to make sure and touch on the pegtibatinase program. We're expecting an update there
later this year. What's clinically meaningful there when we're trying to interpret this data? And what are the next steps in development for the
program?
Question: Gregory Allen Harrison - BofA Securities, Research Division - Analyst
: Great. Well, with that, our time is about up, but I'd like to thank you, Eric and Peter for joining us today, and thank you, everyone out there for
listening.
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