Earnings call transcript Q2 2023

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Operator

Good afternoon, and thank you all for joining. I would like to welcome you all to the Mirum Pharmaceuticals Report Second Quarter 2023 Financial Results and Provide Business Update. My name is Brika, and I’ll be your moderator for today’s call. [Operator Instructions]

I would now like to turn the call over to Andrew McKibben, VP of Investor Relations and Finance.

ahead. go please Andrew, So

Andrew McKibben

Peetz; Thanks, Pam Brika, you call. like welcome of CEO, everyone. joined Radovich, Officer, and our good Mirum Pharmaceuticals’ afternoon, Head Chris and to President conference and by I’d Chief second Operating today Peter Development, to Research our and our Vig. quarter I’m XXXX

filings in today, issued a this results Investors quarter second the Copies our Mirum details news of company’s website. found be release. Earlier and the of release in news can section of SEC updates and for news our the quarter release announcing be found XXXX. Full the can from

statements like and programs, conference management’s pending acquisition about Before I’d to current we product this you of Travere’s course call, bile that begin, future and and regulatory on plans, be during based business regarding acid our will programs statements Mirum’s of forward-looking Mirum, the we development portfolio current commercial our remind certain including expectations, prospects, subject expectations, differ anticipated the are is Mirum’s update SEC. they and market guidance. from and could statements. and results these with these read should materially factors Investors risk set statements, actual duty forth Mirum the forecasts under uncertainties, results no and numerous by to strategies, the filing risks to and financial opportunities in making

over Chris? Chris. the to said, that call With like to turn I’d

Chris Peetz

today. and Andrew, call you, good Thank the joining afternoon everyone on to us

another discuss thrilled are strong at yet to of We growth Mirum. quarter

the in leading patients and pending continued through impact for the become clinic are globally, and of We CHENODAL hepatology on volixibat of of to multi-product CHOLBAM. acquisition franchise pediatric a in track progress LIVMARLI the

commercialize the medicines strategy, markets, in our adult and indications, impact progress substantial LIVMARLI, acquire LIVMARLI to a indications and for cholestatic in international establish saw quarter rare LIVMARLI launch high grow on advance which for additional five-part volixibat U.S., is new last The in disease.

focus of on year. far of these so strides this great made areas all strategic We’ve

quarter, as in second of achieving our total we year-over-year, the from sales U.S. markets growth in LIVMARLI of XX% as business, product commercial LIVMARLI’s net and XXXX, guidance against well performed million revenue revenue. the growing million $XX.X on First $XX.X international well in growth

We about PFIC selling progress approval in LIVMARLI with in application and indication distributor review a our of Canada in markets XX, excited list date. international with are growing under the progress LIVMARLI also great are PDUFA XXXX expansion recent our with also countries the December markets. making efforts

the compelling to We’re forward potential patients. X on bringing Phase data looking based March and PFIC expansion the LIVMARLI to label

year. enrolled this their into data later EMBARK those towards atresia the heading progressing PSC and line studies to addition, positioning study year, later biliary interim top also fully potentially nicely PVC is In and this Volixibat towards analysis portions. expand registrational is

towards we advancing closing $XXX of finally, product And acquisition strategic commercial CHOLBAM, of over CHENODAL annual pillar the acquisition, in are and sales fifth the aggregate two of million XXXX. net with of products on an

deepen line. our As recently, pediatric acquisition our we’ve product this accelerate in we and hepatology to our growth shared leadership expect across

the fit about We these upcoming medicines LIVMARLI the excited in with of CTX. for and and readout and transaction expect X close acid third to quarter bile CHENODAL the the are replacement Phase

our further and our balance, relatively to use quarter. new steady to several and This Financially, the connection us line the balance The addition which to with million revenue with business. ended expense million investors, with compared pending positions opportunity growth. in accelerate Concurrent growth this acquisition. continued was to we’ll the to a of and $XXX a financing synergistic by the the existing $XXX second CHENODAL of strength positioned agreement entered us financial top acquisition, We and on of we a with we strategy. our first to growing quarter a CHOLBAM placement upfront execute are for well offers another cash highly allows an operating sheet fund private quarter levels pending for and payment supported maintain QX

over in an Peter R&D to more to our the that, Pam With gives business before commercial discuss detail pass update. I’ll call Peter?

Peter Radovich

Thanks, Chris.

strong LIVMARLI of net in which see second to quarter with growth of continue demand XXXX. XX% represents We million the in for second sales $XX.X the product quarter LIVMARLI XXXX, over

QX, LIVMARLI continues and by of March. sales business growth label strong net in months driven Our underlying product XX Notably U.S. an with months older new in was to three less demand. than uptake increase expansion of million. age consistent of by with to in This the perform we $XX.X saw patient patients well age,

need Early product the The treatment XX% limit very to setting. disease, to of LIVMARLI the we’re in against Alagille in to U.S. this see the net sales. our addressing continues world performance track of syndrome impact XXXX business growth is real well and guidance in pleased important

Turning to international markets.

we We with continue Pricing which of LIVMARLI. in discussions are Germany XXXX. and continue in in launches European to U.S. see major full the with demand line what saw European launches markets, in expect will in XXXX de throughout starting ongoing strong novo most and in launch we reimbursement France countries

use name and programs XXXX. patient anticipate in throughout of grow distributor European to continue also markets We to

greater multi-product CHOLBAM, BA to strengthened United our this potential biliary recently the presence is Alagille across agreement study Overall, a of readout December in for expansion our and as pediatric in are syndrome, announced that the will deepen and and are opportunity great than for CHENODAL by in PFIC billion, our total hepatology upcoming acquire which forward making $X focused see and progress franchise. label and established we looking We and States the opportunity EMBARK LIVMARLI PFIC atresia. the in to

and as and by unlock similar product amount together putting one the substantial bile are of to portfolio market line scope commercial top access, patient a asset services LIVMARLI distribution the the in synergy of complementary. is the to are hands efforts in bottom marketing There approach and and quite team

for potential low annually digit at patient CHENODAL, diagnosis an a increase to to and treatment providing continue to grow upside rates opportunity CTX the bile single with expect upon approval. We to expansion asset products indication

by strong and combined CHENODAL CHOLBAM all across the expected for with second reported sales million approximately franchise of growth future $XX.X three for $XX.X million and today Travere the Financially, $XX products. quarter totals for net million LIVMARLI

summary, our we deliver on expanded portfolio building In momentum to potential diseases. tremendous and important to with are liver of medicines these the patients rare

I’ll note, to that Pam. turn call over On the Pam?

Pam Vig

Thanks, Peter.

a thrilled are into be We heading to of the half rich year. data second

PFIC. we awaiting are December as First, eagerly Chris XX date PDUFA mentioned, for the

endpoint completed line which on the announced will in be track year, for we the this inhibitor and bilirubin, Phase May X study primary an readout first atresia. Secondly, later data This the this with enrollment EMBARK biliary six-month in has assessing we’re a top data placebo-controlled in the IBAT study for setting.

study This months of be in also when to year of that XX the interim interim PSC been of patients Phase triggered for and randomized Xb a the I’m the is on total end. has say or expected in randomized around patients study will for volixibat have number analysis. VISTAS currently screening three pleased required minimum

addition, interim also expected the Xb VANTAGE in for In same analysis Phase around time. study the the PBC is

a the pivotal into both will move after of trial. studies As these analyses, portion the potentially reminder interim

acquisition. finally turning pending toward And the

could look with trial the X CTX confidence for exclusivity. data the success line high a quarter. and label for CTX forward in If the have CHENODAL to support expansion Phase in RESTORE patients potential fourth in this top evaluating the We orphan of study with positive,

to Alagille Alagille the ongoing syndrome with LIVMARLI’S the and our data symptoms summer, present demonstrated regarding associated XX this abstracts syndrome list pediatric of data as LIVMARLI bilirubin, ability transplant at growing on we treatment. off to came Now, These both reduce of world real and as patients the well significant which the liver with waiting PFIC, LIVMARLI, after in body congresses. European efforts presented data EASL hepatology

syndrome, we LIVMARLI-treated analysis bile in pruritus remain with showing for event-free bilirubin pruritus, that survival free In and six are a in published significantly seminal that addition, of XX% after reductions years. demonstrating transplant hepatology patients and transplant predictive acids serum Alagille

we the the in in remain indications and data And with evidence LIVMARLI our across cements pediatric robust hepatology. in to of committed rare position So our clinical Alagille leadership both upcoming PFIC presence disease. ongoing in growing summary, along readouts

with And I’ll the turn Chris? back that, over Chris. to call

Chris Peetz

The the for growth disease important orphan pediatric programs. third high options in we is for label cholestatic At this quarter Mirum to need hepatology. deliver to three will settings disease proud upcoming products, development treatment and high readouts. continues Pam. the LIVMARLI with year, and in clinical in advances our clinical make Thanks, indications the of rare be across expected and PDUFA team with upcoming acquisition CHOLBAM leader have four LIVMARLI, close in our additional approved expansion CHENODAL in date an of for

world. to positioned expand our and important exceptionally and to medicines disease to forward around rare are impact patients the We in bringing these look leadership

for call the open please operator, that, With questions.

Operator

[Operator first Steve James. of Thank Seedhouse from Raymond you. We have our Instructions] question

Your line is open.

Steve Seedhouse

I guys. questions to wanted about a EMBARK. afternoon ask couple Good Hey.

before The our days what well. there’s have response weeks first bilirubin screening kinetics ultimately sort had in procedure you are consented or after? see enrolled follow-ups I in where couple the one period of a the initiating Kasai surgery they’ve sort is the treatment track in the a I’m as study patient And their before if to lead or like of – just and curious you is and before treatment.

Pam Vig

question. for Thanks the Right. Appreciate it.

the Kasai the learn diagnosis Kasai to procedure the the sometimes for the is EMBARK post born. for study, discussion they happens immediately the patients So prior baby after of when

was can process after either study. criteria the in possible. as happen goal we’re Kasai patients into consent bilirubin get immediately to to the get the for on before the the fully – study enrolled, these is or surgery. these the so are Kasai was to And the patients quickly But surgery There as now no get to –

So any post looking effects Kasai. we’re at bilirubin not

have and this year. of excited read we’re We’re towards really all end enrolling the the to out patients study

Steve Seedhouse

time on great. And curious time analysis? by for say six-month or follow-up enrolled just formal last just there’s like then announced that a bilirubin of through of or analysis, the liver that. patients in already transplant the let’s the you Okay, events six-month assessment point all that the are if six-month Thanks I’m other

Pam Vig

Yes, thanks.

But these six-month extension. that assessing the end thresholds And bilirubin six-month double-blind time in at transplant of point, patients note are period label for then, predictive outcomes at into of treatment the key is as as other over you So other primary bilirubin. as are endpoint the roll secondary of well open we transplant. that

patients those follow continue to term. long we’ll So

Steve Seedhouse

have extension. And I last just label question Okay. then was that just on the open

will months much. so think, total, that do to you’ll wrong, work that the Mirum that if is, post me have control is natural I XX PFIC So some I you you here the question biliary for And analysis. the history through in not, hope ability coming months year? if ways six-month XX leverage in think I’m based databases correct the it so Thanks do or go cohort data similar instance quality in would Alagille at for on on just to think atresia,

Pam Vig

Yes, that’s a great question.

actually that now. right We’re doing

patients those work with with history We’re prognostic kind And about the in of to and looking we’ll working study free registries, registries patients aligning that and understanding a our transplant enrolled continue little are bit natural throughout. thresholds for at those survival. markers more with

points, looking obviously to at We’re then history. natural look versus continue we’ll time at six-month treatment and long-term

of natural the be So discussion timeframe. FDA work history, as we’re time. will supported that the with in by that dataset kind have that plus our we’ll will The the can doing all contain of much package at we and as

Steve Seedhouse

much. so Thanks Great.

Chris Peetz

for Thanks the questions.

Operator

from next of Foroohar comes SVB Leerink. Your question Mani

Mani Foroohar

around bit going the give question. of [Indiscernible]. little A sense quick think trends where How key following XQ Thanks question, are should and what seasonality. season XQ, I guys. for thinking should Can now? metrics year we you each of a we about this about are about a those commercial we year? modeling through know of discussion be last taking think as had sort of and we sort the

Chris Peetz

demand. worth that is Yes, Thanks is how seen feel Mani. about now good beginning into But QX. of we’ve we’re August. we planned QX strong that I mentioning, feel in we’re for heading what the really business question, so, really just

going planned to next couple see really how overall So things the But how feel over the about business we’ll good forward. months. is unfold have

Mani Foroohar

you the looking presumptive of quarter horizon but acquired room think Obviously, how assets, separately margin this you’re time That’s bring should little substantial that evolving you to margin as for Is bit And helpful. from forward that going going going coming first all time? expense Great. On to on, of we together with next have revenue. expansion about put there assets amount see transition what a that’s over through with deal we close be forward? can a further might revenues we from post year? QX of the

Chris Peetz

of picture a overall for of CHENODAL we question. the amount Mani Thanks see Mirum, bringing do and The CHOLBAM synergy. into tremendous

bringing contribute behind of the because the A substantially at of margin why products that about rationale will we’re of into to lot in overlap of Mirum business. portfolio. so these they our So some excited our

We’re financial footing, towards foreseeable I what to say not all going be sound the for a guiding do products but – can very continue expect growing margin, us future. three puts this is and to that the on we

financial to performance that as go. So continue improve will we

Mani Foroohar

helpful. Great. quarter. the Congrats That’s guys. Thanks on really

Chris Peetz

Mani. Yes, thanks,

Operator

We now of ahead have when David go Please Lebowitz you’re Citibank. ready.

Unidentified Analyst

Thanks taking is for This for Hi. question. on Debanjana our David.

the to if you. we insight And closure Thank operating us the So on of as also shift wanted of to closure? update we how post transaction? could the have spend ask could Travere the you timing some might

Chris Peetz

for Yes, question. thanks the

We’re closing this tracking towards quarter.

these excited as right bring start impact over of contribution at to margin have into about we’re cash then, and we expect Mirum. post-close we period, Overall, a So high And close. terms QX. do in the time in to move jumping a products into a they’ll right QX

that in having play will see hands. So these synergy in through products our

that expect QX in having with show at impact So to these from improved performance products Mirum. up

Unidentified Analyst

Okay.

that. follow-up on maybe a just So quick

strategy – [Indiscernible]. current into So this what’s your product on your how incorporating pipeline?

Chris Peetz

– Absolutely. the fit have to speak and strategies we business. into Yes, I’ll Peter of well LIVMARLI planned. these get the with Peter have the LIVMARLI but let through I some can we of some current planning, very

Peter Radovich

we’re from products and bringing to about really Mirum Yes, as bringing into Chris. and about Thanks, excited well. really these talented Mirum several folks Travere excited

synthesis team spectrum out pediatric disorders, and to neurology, hepatologists promoting team that a subspecialties team focuses also continues. are [ph]. a in been bile LIVMARLI identifying patients et right And anticipate acid that have that now on cetera, disorders, ophthalmology, have meta-genetics involved that that’s often physicians will focus Zellweger We with on

liver-focused modest metabolics a we’re footprint. team to team our and expansion have a calling what So and field focused

that about out excited going pretty how plays forward. So

Unidentified Analyst

helpful. very That’s Okay. you. Thank

Chris Peetz

for questions. Thanks the

Operator

Thank Wainwright. H.C. you. We Arce of now have Ed

Thomas Yip

– Yip asking LIVMARLI’s of for collectively everyone. questions Ed. regarding line think afternoon, data for first LIVMARLI’s Good Thomas top that’s data you and Perhaps that Thank positive regarding history earlier? This question taking Do Hi. you you mentioned approval? designation for is a you given data EMBARK couple questions. with orphan Do drug atresia. natural EMBARK enough data biliary along anticipate support to the

Chris Peetz

will doing package this has what say that’s to It Thanks that’s our strategy Thomas the not yet take for fully early be is the the work. work is an at that data EMBARK point bilirubin history established of to been question. too – and Overall, FDA. to the that that endpoint that the with And we’re determination as for approval. natural

to compelling what looking set. be together a really we forward think putting So data will

Thomas Yip

looking the that perhaps endpoint differences Okay. they’re go you the Got can biliary And what EMA of then far so some it. major FDA and over for between atresia? treatable for

Chris Peetz

worth common in conversations, think point that it’s been noting there. question for research the a I a for this in had really pretty is data or we’ve not what lot see that’s our clinical Thanks there Yes. done of space. of I and mean, we view there

study the setting. in is largest going really be to has intervention And that few studies early EMBARK of of and the the the first It’s landmark. So IBAT actually one study an the that after Kasai. a

patients. really to set to important advance data bring care these for So forward

Thomas Yip

for the both you for VISTAS data Can both of it. what question later then us Got studies this year. expected perhaps see? we to And VANTAGE analysis you can mentioned volixibat, type interim final expect one and tell

Pam Vig

thanks question. the for Yes,

blinded So PSC is VISTAS for a this interim. the study,

part or for two need study any the potentially the of sharing and is but to on selection So then we if not, and won’t upsize will registrational carry study. dose be data, if it then

able study So but line data any would that communicate be on. expect there, carrying continuing out expect top wouldn’t to and to the is on

we’ll that line PBC open data. VANTAGE study, is and data interim we’ll look we able the the For be later. will a to and be so top sharing sharing be you an at This with analysis have

Thomas Yip

again forward and VANTAGE from Understood. study. questions looking the Okay. to the data Thank you taking for

Chris Peetz

Yes, thanks Thomas.

Operator

Our Thank Brian from next question Skorney [Operator with Baird. you. Instructions] comes

Unidentified Analyst

Brian. is Charlie This on Hi. for

SG&A, ask it somewhat seen to the we’ve wanted about the climbing several steadily I over quarters. past So

start force? Will commercialized. that that sales about bile getting to you we kind that’s Or regulatory do that you. this should to leverage line, different a closer along trajectory Just you to commercial forward as of strategy What going the And kind going you if team field adult volixibat liver you to a taking as diseases? are want can have of considering are particularly also think thinking the from force acid expect these rising, keep integrate take. currently? that similar you know, what Thank and require that gets hopefully Travere, to

Chris Peetz

see Thanks strategy about the Peter questions. field SG&A on bit I is we and to by And for the regulatory of brought U.S. pass launch the we what and modest markets some for team. the we’ve – on. SG&A, will and over in international to a the really that prior increases what over kind talk of initially it this now comment driven have quarters,

just So modest CHOLBAM the business, with incremental expense, is some but and to expect. we’d over And that bring what adding compared the SG&A SG&A time base in incremental opportunity. CHENODAL line top increase really will for then

the synergy earlier, As fit LIVMARLI. a mentioning of lot Peter with those we know, there’s approach in was markets you how and

And contribution attractive experience So Excited we folks the family. products will – hands. bringing Travere. overall, our total but over with who those products from with some are be quite into those about bringing the people in have these great Mirum

volixibat, move will an into we hepatology. expand to as adult to forward be opportunity Now which

the syndrome pruritus as is for using endpoint what pruritus these Peter on registration review comment for commercialization primary the for outcome endpoint Alagille the approach First, that’s strategy. adult And the the let ongoing for we’re to the incorporate the approval. indications. I’ll and and the comment to registration PFIC, on studies similar

Peter Radovich

Yes. Thanks, Chris.

yes, our launch and to infrastructure volixibat to I would So team to commercialization able think be we leverage adults.

Our current broader volume goes to maybe liver we lot hepatologists, expand team pediatric primarily to adult to would a doctors. But decile, of group larger adult is focused the higher of look gastroenterologist.

of I that for an as it build kind So of launch. incremental think

Unidentified Analyst

color Thanks on Great. the congrats quarter. the for ton and a

Chris Peetz

the for Thanks questions.

Operator

Thank final call for to hand to Chris the like any you. back remarks. over I’d

Chris Peetz

Great. to Good everyone for Thanks, day. a bye. today’s joining again operator. thanks call. Have And great

Operator

confirm Please can disconnect. now this for call. of day Thank your joining. rest you you I does a may and today’s conclude lovely all have

Mirum Pharmaceuticals (MIRM) 3 Aug 232023 Q2 Earnings call transcript