David Lebowitz: Thank you very much for taking my question. On the 1.75 point difference on pruritus, could you just elaborate as to whether you’re talking about through the blinded portion or through the actual pivotal portion at a subsequent time point? And perhaps give us some view of what that point and how you will use it to consider upsizing if that is needed, what type of thresholds we could expect?
Joanne Quan: Yeah. Thanks for the question. We’re not going to get into the details of the study design, but I just provided some of the number so that you could get a sense of what kind of treatment effect we’re looking at. The 1.75 point treatment difference and the 3 in terms of standard deviation is just a general number that we’re looking for the overall design of the study. So, we won’t be sharing any specifics in terms of kind of where we are with the interim. Obviously, we’ll share the results of the interim since we’ll be blinded. We certainly hope that we’d be continuing the study. So that’s what we hope to be in to see in June.
Chris Peetz: And I want to add to that, David, is that the measurement is actually looking at over time, right? It’s the month three, four, five — sorry, four, five and six actually of the treatment effect for the final analysis. That does allow to add power and try to deal with any potential for placebo response because you’re looking at multiple time points and how they roll into the analysis. That’s another kind of factor to the study design. Applying what we used from the PFIC study and the adult settings.
David Lebowitz: Got it. Thank you very much for taking my question.
Chris Peetz: Yeah. Thanks for the question.
Operator: The next question on the line comes from Jon Wolleben of Citizens JMP. Please go ahead. Your line is open.
Jon Wolleben: Hey. Thanks for taking the question. Just logistic one for me on PBC and PSC. When you select the dose, the patients on higher dose get to roll back in at either placebo or the new dose, or do you have to re-enroll patients? And can you comment on how long enrollment could take to complete in both those studies? Thanks.
Chris Peetz: Thanks, Jon, for the question. Just on timelines, we’ll give a more formal update on what we expect to see for the — to get to the full data set in June when we have the interim. I’ll let Joanne speak to a little bit of mechanics of how patients flow through the study.
Joanne Quan: Yeah. So we’re going to be continuing — we are continuing enrollment in the study at this point. And then, we’ll be continuing with one active dose and placebo. So we expect to include all the patients ultimately in the analysis when we ultimately unblind the whole data set.
Chris Peetz: Thanks for the question, Jon.
Operator: The next question on the line comes from Mike Ulz of Morgan Stanley. Please go ahead. Your line is open.
Unidentified Analyst: Hi. This is [Rohit] (ph) on for Mike. Can you just provide any color on the ongoing launch prep for PFIC? And when do you expect patients on the expanded access program to get on paid drug? Thanks.
Chris Peetz: Yeah. Thanks for the question, Rohit. In U.S., obviously, launch is underway, seeing prescriptions come in for LIVMARLI, PFIC patients now. We have talked about — we have about 25 patients in the U.S. who are on clinical drug. Most of those are eligible to roll over at this time, and we’d expect them to come over to commercial drug in the coming quarters throughout this year. So that’s how we see the cadence playing forward.
Unidentified Analyst: Thank you.
Operator: The next question on the line comes from Ed Arce from H.C. Wainwright. Please go ahead. Your line is open.
Thomas Yip: Hi. Good afternoon, everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you for taking our questions. So first, following up on U.S. performance for the LIVMARLI PFIC. Just wonder of the $42.8 million net sales in the first quarter, how much was it from PFIC approximately? And then also what are some early launch metrics that investors came up to?
Chris Peetz: Thanks, Thomas, for the question. In Q1, there really — there’s no PFIC contribution in there yet. And we’re just — the approval came in March and just now kind of rolling over those clinical patients. So, expect that revenue contribution to be pretty minimal from PFIC over the next quarter or two as we get into the back half of the year where we expect more reimbursement.
Thomas Yip: Got it. And then switching gears to the European front. Have you any interaction with EMA or CHMP recently given your expectation on a recommendation in the first half of this year? And if positive, any ongoing commercial preparations for European market for PFIC?
Chris Peetz: Yeah. Thanks for the follow-up there. On the EMA discussion, you have over the — we have been active in discussing with EMA. As I mentioned, feel confident in our arguments and hope to have an update on that soon. Som no formal determination yet. And maybe Peter can speak a little bit to the launch prep in Europe for PFIC.
Peter Radovich: Yeah, certainly, upon a potential approval, it would be ready to launch LIVMARLI in Europe. Prescribers for PFIC are essentially identical to the prescribers of LIVMARLI for Alagille syndrome. So you’ll be ready to go with dossier submissions to help technology agencies, et cetera, to work with pricing and reimbursement and [indiscernible] level as well.
Thomas Yip: Okay. And then one last question from us. Can you discuss some of the main drivers for the bile acid product sales that’s slightly by $2 million quarter-to-quarter? Can you provide some major factors?
Peter Radovich: Yeah. I mean we mentioned the Change Healthcare cyberattack was kind of in play for our entire portfolio. I think if you look back over time in the bile acid product sales, there are — there’s quarter-to-quarter volatility given the ultra-rare nature of the disease in small number of patients over time. But do see an opportunity to continue to build on those products this year, mid-single-digit year-on-year growth, consistent with historically is our expectation. And going forward, really excited about potential approval by FDA next year for CHENODAL and CTX and the chance to go out and find more patients there.
