Christopher Peetz: Yes. And just to recap, one of the points made earlier, the eligibility criteria for the VANTAGE study does not have an alkaline phosphatase criteria. So it includes patients that are traditionally thought of as first line that has really only UDCA as on label and still experience the same rates and severity of pruritus as later lines of treatment. So a lot of unmet need across the PBC patient population.
Brian Skorney: Great. Thanks.
Christopher Peetz: Thanks for the question.
Operator: Thank you. The next question comes from the line of Ed Arce with H.C. Wainwright. Please proceed.
Ed Arce: Hi everyone. Thanks for taking my questions and congrats on another strong quarter. I have three if I may. Firstly, on the VANTAGE study in PBC. As you said it’s a blinded data readout. Obviously, this is as you mentioned, basically pruritus border versus placebo and whether it’s stat sig. But I’m also wondering if there are specific thresholds of activity on pruritus that you’re looking at not just so much to proceed but also as you think about the competitive landscape and where you’d like to see that come in? Secondly, if you could speak a bit about the PFIC opportunity in terms of 2024 sort of the sales the speed of the sales ramp kind of what you’re expecting the trajectory to be through the remaining quarters of this year? And then lastly I’m sorry I didn’t hear when Peter was reviewing — I think it was Peter the numbers for LIVMARLI both U.S. and international as well as the bile acid products for the fourth quarter? Thanks so much.
Chris Peetz: Great. Thanks for the question. Maybe I’ll just hit on recap one of the points on VANTAGE and then pass it over to Peter to talk about PFIC and recap some of those sales numbers. The way we think about VANTAGE and volixibat in PBC, it really comes down to this — the highlight here on lines of therapy and where the various agents are labeled and expected to be labeled. The majority of patients are first-line patients and the majority of them have pruritus. So, that’s really the primary unmet need that we’re going after. So, showing a significant impact on that pruritus we think will be very clinically meaningful. And that’s the lens that we’re going to be taking towards that interim data when we look at it and make a decision on next steps and continuing to roll into the pivotal portion of the study. With that, I’ll pass it over to Peter on the next two points.
Peter Radovich: Okay. Sorry, I’ll try to speak up a little bit here. So, on the PFIC 2024 revenue expectation piece, I think we’ll be — upon a potential approval here in March, we’ll be spending a fair bit of time working closely with payers to get LIVMARLI positioned in their new-to-market policies. So, I think you think about 2024, we’d expect a lot of free drug or path with PFIC really coming in more in 2025. Somewhat similar to what we saw in the Alagille initial launch where the early quarters were high path drug. And then in terms of the numbers from Q4, LIVMARLI totaled $41.4 million worldwide, $31.4 million U.S., $10 million international. And then bile acid products were $28.1 million for Q4.
Ed Arce: Great. And then maybe just a further clarification on PFIC. I appreciate the comments. Just wondering given that you mentioned earlier there’s about 20-ish patients right now on expanded access. How soon would you expect those to be able to roll over onto commercial drug?
Peter Radovich: Yes. What we saw in the Alagille launch is that occurred in a quarter or two generally is what we saw. And so, yes, I think that’s probably consistent with our expectation for those 2025 or so. Question and Answer Operator Message
Ed Arce: Thanks so much.
Operator: Thank you. The next question comes from the line of Jonathan Wolleben with Citizens JMP. Please proceed.
Q – Unidentified Analyst: This is Catherine [ph] on for Jon. I had two kind of quick questions. One is kind of follow-up on volixibat and just kind of, how you guys see it fitting into the PBC paradigm in the setting of other approved agents that might potentially be effective also on pruritus, whether you see kind of the combo therapy sort of a monotherapy for earlier patients? And then also just as far as preparing for the PFIC launch, I know you said that there’s not going to be too much of an investment as far as SG&A growth, like what else is kind of being done to sort of get the word out there about PFIC there’s mostly patients already know that it’s coming.
Chris Peetz: Thanks for the questions. And just to kind of recap the PBC positioning one more time here. The VANTAGE study includes first-line patients, that really are when you look at the eligibility criteria for the PPAR programs for example and how decide gets used outside the US. We are upstream of that setting where when a patient is biochemically controlled, they can still have substantial pruritus, So that’s the area where IBAT can play a very unique role in being in front of the other second-line therapies, PPARs and OCA for example. So, pretty unique positioning that we see for PBC. I’d add on in PSC, really exciting opportunity here where volixibat is positioned to be the first and only therapy for PSC by using pruritus as an endpoint really gives an outcome to use for bringing a new therapy to these patients. So, quite excited about the positioning there. I’m going to pass it over to Peter for part two here.
Peter Radovich: Yes. In regards to PFIC obviously, there’s been — there’s no promotion until an approval. But I mean I just kind of emphasize, that it’s a really small number of physicians that take care of these patients. In the US, I mean you’re probably talking about on the order of 100 positions in the entire country that take care of PFIC patients. There have been presentations at the major medical conferences on the data — Phase III data, as well as the Phase II data going back for years. So, I think there’s a kind of a relatively high awareness of the data. And certainly from Alagille approval and commercialization, a lot of comfort with LIVMARLI’s clinical profile kind of familiarity, with using it, prescribing it, working with our patient support hub the Mirum Access Plus program, co-pay support, et cetera. So, I think that’s probably a fair summary of where things stand today.
