Peter Radovich: Yeah. I think with all products we continue to see growth in line with historical trends, certainly with CHENODAL recently announced Phase III data for CTS and potential approval next year for CTS. I think there’s an opportunity. CHENODAL has never been promoted for CTS before. So I think there’s an opportunity to find more patients through disease awareness and hopefully increasing the diagnosis rate. One thing we know about CTS is maybe only about 10% of the patients are diagnosed and under management. So the opportunity there is to try to identify more patients and put them on therapy.
Lili Nsongo: Thank you.
Chris Peetz: Thanks for your questions.
Operator: The next question comes from the line of Mike Ulz with Morgan Stanley. Please proceed.
Unidentified Analyst: Hi. This is Rohit on for Mike. Thanks for taking our questions. Can you just talk about your expectations for the upcoming LIVMARLI PDUFA and PFIC? And any launch preface associated? And do you think that any patients are currently using it off-label? Thank you.
Chris Peetz: Thanks for the question Rohit. On the regulatory front where we expect to be so excited about the PDUFA date coming up. And I’ll let Peter speak a little bit to how we’re preparing for that and some of the first opportunities we see there.
Peter Radovich: Yes. We’re really excited about the potential approval for LIVMARLI and PFIC. I think the March data reinforced the strong value proposition that LIVMARLI offers to our various stakeholder groups and I think that will certainly help us. The physician prescribing universe is essentially identical to the Alagille audience so there’s really no need for meaningful operating expense increase to access it. And we do have a number of patients in the mid-20s who are receiving clinical rollover or expanded access to LIVMARLI, who would be eligible to rollover to commercial on approval.
Unidentified Analyst: Thank you.
Peter Radovich: Next question.
Operator: The next question comes from the line of Steve Seedhouse with Raymond James. Please proceed.
Unidentified Analyst: Yes, hi. This is [indiscernible] on for Steve Seedhouse. So our first question is related to the gross margin. I think you mentioned there was an inventory charge related to the acquisition in 4Q. Just what are your expectations for gross margin in 2024 and perhaps also the OpEx trajectory in 2024?
Eric Bjerkholt: For us gross margin we do expect that the intangible amortization will continue. I mean it’s largely related to the bile acid acquisition intangibles, which we’re amortizing over 50 quarters. As far as sort of traditional cost of goods, it consists of the actual cost of product and royalties. So that will continue at approximately the same sort of percentage of sales. And then we did have a larger than we expect going forward amortization – or reserve for the inventory that came with the acquisition. So we might have some reserve in some quarters but not to the extent we had in the fourth quarter. In terms of overall operating expenses R&D and SG&A. Fourth quarter is probably pretty representative of what we expect the next few quarters.
Unidentified Analyst: Okay. Okay. Thank you very much. And then just a question on your overall enrollment dynamics in VISTAS and VANTAGE. I think in VISTAS your interim is only on 45 patients. So can you comment about the overall enrollment target dates? And do you see any differences between the studies in terms of the enrollment dynamics?
Chris Peetz: Thanks for the question. I mean the simple answer here is we have patients in for the interim we’re continuing to enroll for part two now. And we’ll be able to give better guidance for the full study enrollment at that interim when it comes up.
Unidentified Analyst: Okay. Appreciate it. Thank you very much.
Chris Peetz: Yes, thank you.
Operator: The next question comes from the line of David Lebowitz with Citi. Please proceed.
Unidentified Analyst: Hi. This is [indiscernible] on for David. Thanks for taking our call. We wanted to ask about the blinded PSC interim analysis. So besides the dose selection, would you share any other data points at a blinded basis?
Joanne Quan: So we will be blinded in this interim and the phase design so that if it passes the threshold, it is designed to be predictive of a clinical people and statistically significant positive pivotal analysis in the end. So that’s all I can really share with you at this point. And it’s really the special is developed based on what we know about the drug this class of drugs PSC in general and pruritus. So we feel pretty confident in terms of the design being robust and this being kind of well set up to a productive registration study for us.
Christopher Peetz: In terms of communication at the point of interim for the VISTA study, assuming a positive interim, we would communicate that the interim has occurred and study continues as planned, which would be the extent of the information that we received here on the team as well.
Unidentified Analyst: Okay. So as a follow-up to that, could you tell us a bit more about — I mean, while unlikely, is there any other scenario like that would play out if somehow like if you see that like the efficacy is not crossing the threshold on a blinded basis that was specified?
Christopher Peetz: So the study design in the event where that threshold does not met, basically converts to an open interim analysis. We’d be able to look at the look at the data, share top line finding of it and what the next steps are for the study in that scenario.
Unidentified Analyst: Okay. Thank you for the insights.
Christopher Peetz: Yes, thanks for the questions.
Operator: Thank you. The next question comes from the line of Brian Skorney with Baird. Please proceed.
Brian Skorney: Hi. On PBC, beyond pruritus, how are you thinking about the impact on outcomes and other markers in VANTAGE? And how can this help you make the case to physicians and patients?
Christopher Peetz: Yes. Thanks for the question. I’ll let Joanne speak a little bit to kind of the registrational plan for PBC.
Joanne Quan: Yes. So in terms of the interim, we’re just going to be looking at top line. So pruritus [indiscernible] and safety as top line. And as you know, it is a big issue in this particular patient population so there’s really no particular therapies. So we’re pretty confident that this study, the way it’s designed actually addresses an important unmet medical need at this point.
