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: Richard Law - Goldman Sachs - Analyst
: Fantastic. So LIVMARLI, a lot of stuff happening there, right? So it's proved in ALGS, and it's a IBAT inhibitor now is facing competition from (inaudible)
, which approved in PFIC and recently ALGS. Can you maybe talk about the differentiation between the two and provide some color on that
competitive dynamics so far that you see between these two parts?
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JUNE 12, 2024 / 2:00PM, MIRM.OQ - Mirum Pharmaceuticals Inc at Goldman Sachs Global Healthcare
Conference
Question: Richard Law - Goldman Sachs - Analyst
: I think I got it. And maybe a little bit about the market dynamics or competitive dynamics between the two. You guys are -- you guys have to defend
[algeos] as bill-pay comes into market and then you guys have to penetrate the other markets that they've been already operating in. Little bit
about the strategy there, how you see these two markets plants?
Question: Richard Law - Goldman Sachs - Analyst
: I think, got it. And how much of the -- of your sales guidance you're (inaudible) sales guidance for 2024, how much is that driven by LIVMARLI? And
also that the how much if it's also from that growth expansion?
Question: Richard Law - Goldman Sachs - Analyst
: I see. Okay. So now alongside with the approval in PFIC, you guys submitted an SNDA to support a lower age cutoff from five years of age to the
three months, which is in line with your Alagille indication of (inaudible) PFIC indication as well. So what's driving the confidence that you can
make that change and what impact would that have for PFIC?
Question: Richard Law - Goldman Sachs - Analyst
: I think got it. So why don't we switch gears to Volixibat, your second IBAT inhibitor. So why do you need to develop another IBAT inhibitor? Why
can't you just use LIVMARLI and go into other indications?
Question: Richard Law - Goldman Sachs - Analyst
: I think, got it. And maybe a little bit about the unmet need for PSC and PBC as well?
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JUNE 12, 2024 / 2:00PM, MIRM.OQ - Mirum Pharmaceuticals Inc at Goldman Sachs Global Healthcare
Conference
Question: Richard Law - Goldman Sachs - Analyst
: And that's always been difficult to pass, be the first one to go into new setting. So why we're anxiously waiting for the Phase 2b interim data in PSC
and also P4 PPC, that's coming out in June, right? Maybe walk us through the clinical design a little bit more and then the patient population for
these two trials?
Question: Richard Law - Goldman Sachs - Analyst
: How often do they monitor that?
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JUNE 12, 2024 / 2:00PM, MIRM.OQ - Mirum Pharmaceuticals Inc at Goldman Sachs Global Healthcare
Conference
Question: Richard Law - Goldman Sachs - Analyst
: I see. Got it. So you're VISTAS interim will be blinded. So what should we expect to hear and what should we expect the study to continue as a
blinded -- on a blinded basis?
Question: Richard Law - Goldman Sachs - Analyst
: I see. Okay, got it. And what should we expect from the interim analysis for VANTAGE?
Question: Richard Law - Goldman Sachs - Analyst
: I see. Got it. And then going back to the VISTAS program, I think you mentioned as a threshold for stopping the study because, you don't see the
separation with placebo futility of the study? Is there a separate threshold where you do stop it because, we see overwhelming effect as well and
how you define that?
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JUNE 12, 2024 / 2:00PM, MIRM.OQ - Mirum Pharmaceuticals Inc at Goldman Sachs Global Healthcare
Conference
Question: Richard Law - Goldman Sachs - Analyst
: I think, got it. Okay. So what do we talk about the commercial opportunity in PSC versus PBC? What's the burden to provide us in these settings?
And how do you view the market opportunity for both?
Question: Richard Law - Goldman Sachs - Analyst
: I see. Okay. So how are you thinking about the regulatory timelines and potential filing? And also have you thought about pricing for these two
indications?
Question: Richard Law - Goldman Sachs - Analyst
: I see. In contact to pricing a little bit so you have LIVMARLI, which is also not a IBAT inhibitor, we talked about. How do you, I mean when you factor
in pricing, do you also look at LIVMARTI or you just treat that as completely separate products?
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JUNE 12, 2024 / 2:00PM, MIRM.OQ - Mirum Pharmaceuticals Inc at Goldman Sachs Global Healthcare
Conference
Question: Richard Law - Goldman Sachs - Analyst
: I see. I think we mentioned before that LIVMARTI also just some compassionate use in these two new indications as well. Do you -- how do you
factor that? And is that going to continue you think you're going to (technical difficulty) how will with that dynamic change?
Question: Richard Law - Goldman Sachs - Analyst
: I see. Okay. So a lot of future, I guess, expansion with these products.
Question: Richard Law - Goldman Sachs - Analyst
: Fantastic. Okay. So why don't we switch gears? I think we only have about 10 minutes left. To your other two products that you recently acquired
last year, which is CHENODAL and CHOLBAM. Remind us on the history of these two assets and the rationale behind acquiring them?
Question: Richard Law - Goldman Sachs - Analyst
: I see. And I think you guys are filing a NDA submission for that. (inaudible)
Question: Richard Law - Goldman Sachs - Analyst
: I see. So if it's already been used in an off-label setting and I think the FDA recognizes that. Why do you need to get that as NDA? Why not just, you
already being used in the market? I mean, how like what would that do for you from a commercial perspective?
Question: Richard Law - Goldman Sachs - Analyst
: Okay. How has the commercial transition been since you guys acquired them? And why do you guys think that you guys are a better parent? What
is to be (inaudible) ?
Question: Richard Law - Goldman Sachs - Analyst
: I think. I got it. We have five minutes left. So if the audience have any questions, please raise your hand and we'll get to you.
Okay. So why don't we continue on talk a little bit about high-level strategy and BD, maybe give us a state of the affairs of your financial position
and how you are thinking about profitability going forward?
Question: Richard Law - Goldman Sachs - Analyst
: I think. Got it. And maybe speak a little bit about your take on BD in terms of you guys acquired these two assets. How should we think about your
strategy from a BD versus organic growth?
Question: Richard Law - Goldman Sachs - Analyst
: I see. About a blue sky question for you. So what's the long-term aspiration for Mirum and what would the company look like in 10 years from now?
Question: Richard Law - Goldman Sachs - Analyst
: Commercial partnerships come based on some of these interim readouts here coming up?
Question: Richard Law - Goldman Sachs - Analyst
: Fantastic. I think we're running out of time. So I'll leave it to you, Chris, for the final remarks.
Question: Richard Law - Goldman Sachs - Analyst
: Fantastic. Thank you so much again and thanks, everyone.
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