Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) Q1 2023 Earnings Call Transcript

Peter Radovich: In terms of — thanks for the question, Ryan. In terms of Biliary Atresia, I think the time to having a randomized data set was a big part of our thinking and our strategy here. The EMBARK study on track to have data second half of this year will give us a really sizable lead in terms of having data on LIVMARLI, a really robust data set on LIVMARLI in this setting. We also have a feature of the study that is not in the bill base study, where at six months, patients roll on to open-label therapy. So the effect of starting treatment later is really important to look at from the prevalent patients that are out there. So that’s a really key part that we’re looking at here. And then lastly, similar to what we’ve seen in the other settings, our higher dose of LIVMARLI, I think, is we expect to have a bigger clinical impact.

So I feel like we’ve really advanced our understanding of how to dose IBAT inhibitors and really think that that’s going to show up in our top-line data.

Ryan Deschner: Thank you very much.

Peter Radovich: Thanks for the questions.

Operator: Thank you. We have our next question coming from Debanjana Chatterjee from Citi. Debanjana your line is now open.

Unidentified Analyst: Hi, thanks for taking our call. I’m on for David Lebowitz from Citi. So we were wondering if you could comment on the ex U.S. inventory build? And what should we expect in terms of the sale strategy ex U.S. going forward?

Chris Peetz: Yes. The — in terms of the $4.4 million in sales we saw in Q1, a lot of that was from Germany and Western Europe, where there’s really very little effectively zero inventory, true demand sales there as we get started in those countries. We do have some other — the balance of the sales in international our named patient programs in distributor markets or markets that we’re not directly selling in, but our partners are Central Eastern Europe, Middle East. And generally, what happens in those dynamics is there’s a country-specific mechanism and individual patient identified the physician and the — our distributor partner works through a local reimbursement access mechanism. Oftentimes, those patients get three, six and even in some cases, we’ve seen 12 months of supply ordered for one patient.

So that’s kind of where — so obviously, you’re not going to see a consistent refill cadence every 30 days like you see in the U.S. with those kind of orders. So that’s kind of the dynamic we see. And in terms of visibility and the guidance we have for 50% growth is based on the U.S. sales in international setting, we’re really excited about the feedback we’re getting, and we’re excited that Germany has gone really well. And I think from the sort of the patient position perspective, looks a lot like the U.S. But it’s just too early to provide firm guidance on international given that we just kind of get started there.

Unidentified Analyst: That’s very helpful. Thank you.

Chris Peetz: Thanks for the question.

Operator: Thank you. We have our next question comes from Ed Arce from H.C. Wainwright. Ed your line is now open.

Unidentified Analyst: This is Thomas here asking a couple of questions for Ed. First, congratulations on the very impressive quarter. So just trying to tease out the — of the 600 patients with Alagille syndrome that’s being treated with LIVMARLI globally. Can you tell us roughly what percentage stay on chronic segment? And if you can provide some major factors for patients to stay on LIVMARLI or by first stay off LIVMARLI as well — that would be appreciated?