MIRM - Earnings call transcript Q2 2022 | Mirum Pharmaceuticals, Inc.

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Operator

Good afternoon. My name is Chris, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Mirum Q2 2022 Business Update. [Operator Instructions] Ian Clements, Chief Financial Officer.

You may begin.

Ian Clements

afternoon, good and Chris, everyone. Thanks, welcome I'd quarter Mirum second to conference like call. to XXXX Pharmaceuticals you I'm by our Chief Operating Pam joined Peetz; Officer, Chris today Vig. Peter our President Radovich; and Head R&D, CEO, of and our this the results announcing XXXX. for news of company's quarter afternoon, Mirum second Earlier a release issued the of from news Copies can found website. of release this in our be filings SEC the Investors section

duty numerous certain would the the ended we they I'd including update these anticipated I results and statements, plans, with factors set like Mirum's begin, management's like statements are from Chris. making reports course will that and subsequent market actual prospects, to this the over Chris? forth read risk we you on to the during programs, and uncertainties, to development to and Before that XXXX, by materially differ statements filed these Mirum financial guidance. call, SEC. results call of conference said, the be based no business our forecasts and year to forward-looking With in risks about is December remind Mirum for strategies, subject opportunities regarding XX, could and programs the Mirum's any statements. expectations, turn current should Investors and XX-K under

Chris Peetz

our cholestatic In reflects second Alagille patients we which achieved for quarter, Thank you, in pruritus. life-changing commitment Ian quarter net impact and good and afternoon the sales, to the LIVMARLI great for $XX.X everyone. It's and with been Mirum. of another LIVMARLI expertise million team's

disease. a becoming leader goal rare quarter's This our progress furthers in in

U.S. our care for why across United as continued we come so setting. success in of about LIVMARLI Alagille the launch become excited are are impact and success We programs. to the of to look States with in and of growth what's this all The syndrome standard our patients in are forward proud

approvals international and U.S., look to for Alagille the This the anticipated forward with possible around approval. quarter of disease upcoming realizing syndrome. potential European burden of First, the has we broader launch for promise what's shows and U.S. outside severe starting LIVMARLI LIVMARLI broadly the the European in globe, fourth more patients the

Alagille data, as clinical showing provides our of impact evidence lives we've as in in the LIVMARLI to syndrome well long-term pivotal improvement across recent and number seen improve Second, in of a presentations potential for cholestatic settings. volixibat the outcomes,

which landmark be next important the are over We our later and PFIC will year. our X opportunity readouts months, progressing volixibat for programs data X multiple from XX study, Phase late-stage this will LIVMARLI which of the data expansion LIVMARLI an clinical generate first label

mission our both update. have by of to I'll dedication that, of a progress we to possible important bring to busy With commercial to promising LIVMARLI end head world. pipeline patients the XXXX. our is a lot new Peter, team and unwavering as turn over will forward made of commercialization look our provide The treatments in a the who and into to collective Peter? We around it

Peter Radovich

Thanks, Chris.

disease, as we're for $XX.X LIVMARLI's color hands success first net LIVMARLI, launch commercial we medication delighted and sales million ongoing are We get and product only further in around into patients. Mirum's more FDA-approved this share I'll with what business. the the Today, of the seeing

therefore inventory demand. no As a product patient of accurate our is in are there reminder, a reported representation very sales, which

a closer taking look. Now

discontinuations, by what new to with which steady limited patients revenue was addition in set. saw treatment mirror retail Alagille well quarter a driven the syndrome consistent continue as Second as we clinical cadence of trial

strong been dispenses being over with of achieved which reimbursed, XX% the real a side, of launch. have we point On payer has our the LIVMARLI goal

But the still to it's first acceptance United about early in days States. the market. in payers and rapid grow thrilled quarters patients clear of by significant in of with the launch we're the room physicians, are LIVMARLI the on We three

that physicians launch. received research substantially has market increase utilization since group our fact, intend In of to suggests the prescription LIVMARLI a beyond that

forward, United continued States. the quarter-over-quarter we in expect looking growth So

Now plans for launches. our international turning to LIVMARLI's

about LIVMARLI excited Europe Mirum are the We European been potential with Western engagement and this early in fourth other payers the in has of in key team approval The quarter. active year physicians, stakeholders.

a over expect we launching in country the of following country year approval. typical Europe, is medicine or by to progress As rare reimbursement two disease

first in Western by followed launch major We approval expect EMA other Europe. markets after Germany in to shortly

populations worldwide, as to over call X top Europe, on approvals upon geographies. LIVMARLI patients with of on are as roll our this, program, XXX Western ongoing total, we program starting to Alagille In And upon therapy local availability. potential XXX and over Alagille to to the year Pam? approvals clinical commercial progress patient worldwide approvals States, who And over local we the have roll our to LIVMARLI introducing be will I'll these PFIC pipeline. outside this commercial commercial that towards provide to Pam the new early nearly to we on also now Beyond commercialization of currently commercial syndrome update over eligible patients and in currently partners have therapy hand great regulatory the United also clinical expect availability. making in an

Pam Vig

foundation rare well of XXXX quarter for to our Peter. milestones build to team medicines which important deliver XXXX, continued disease to the and patients. Thanks, upcoming our life-changing positions the for XXXX, In has second us

our Phase to demonstrated to X-year MARCH-PFIC applied breakthrough trial of the data in And the fourth our clinical survival serum growth our response expect PFIC, this these and improvements transplant-free liver in with sustained X significant First response in a findings LIVMARLI, Also INDIGO led of Phase long-term saw designation function. have also which acid this up, finding builds we line in responders, This bile remarkable and of learnings with experience the in from all dramatic quarter in we study. clinical X X MARCH-PFIC year. LIVMARLI disease. pruritus, Patients for PFICX. INDIGO been of from study Phase study the landmark top INDIGO on

This with line conducted than than XX Phase our Now in more previously largest patients study, randomized reminder, next quarter. all was a tested doses results date, X forward clinical as look subtypes sharing to is and randomized. study top higher this PFIC clinical PFIC includes at the we to study

We out also have four additional that late-stage studies XXXX. expect in to we read

for and no cholangitis the analysis Phase advancement volixibat We conduct line disease the Xb by largely on First, therapies. midyear this be expect impacts revised to a VISTAS environment clinical approved progressive with studies the treatment the study in is time sclerosing driven primary major of volixibat interim positions with This now in XXXX. to running screens. of current study, the supply the extension portion we We're Study we and continue related have has outside the of otherwise several and with from to feedback some get site optimistic patient and the positive openings well, site study, U.S. sites. international had the about chain. direction openings gone conduct patients the of now open-label recently in

patients of the an first with streamlined for intrahepatic a readout enrolling cholestasis Regarding launched year. We the half protocol in of for of and patients interim We're in recently OHANA next are the amendment. pregnancy. the phase planning study study open-label

found in from long-term across Ian. over Phase presentations our significant Xb remain half next our And all atresia. on the website. driving our we we year, in in data research call cholangitis track Ian? well biliary primary this both of are study and delivered of And adults study Alagille to proud as as dedicated noteworthy in Presentations be and And we rare corporate Xb EMBARK the biliary with and EASL. turn at data second and LIVMARLI that disease. VANTAGE these with note, pipeline Finally, the for primary will we in response section And quarter on outcomes data collaborative on publications, of volixibat Phase presentations to the LIVMARLI remain both from I can Publications ESPGHAN syndrome the of and academic

Ian Clements

a today, release Earlier that included quarter, the results Thanks, financial Pam. for which summarize. briefly press issued I'll we

can today. also details Form XX-Q filed full Additionally, in found be the

the by we Chris first $XX.X a highlighted recognized net XX% in sales XXXX. over of quarter the Peter, second million and sequential quarter, of As increase product

growth continued LIVMARLI of revenues quarters. over coming expect We the

operating and our of expenses SG&A and I $X.X quarter these total of million. million. that $X.X Our research which million, development compensation includes noncash to million sales $XX.X expense note expenses million, related numbers include for of the also were expenses cost of should $XX $XX.X of stock-based

our June At now we of commercial cash reduced for subsidiary business quarter funded. equivalents in ended the strengthen global second ended per growing the $X.XX was presence investments with For licensing a XXXX, the LIVMARLI close acquisition, net and a position well of cash, XX, contribution critical XX, In owned summary, recently $XX.X line June or Mirum. and and and the the milestone obligations strong To with milestones XXXX, royalty million Satiogen, we our had is wholly years. Mirum further million. model, acquisition $XXX to and remains our loss partner quarter coming expand which of of was volixibat achieve top we're a over efficient previously and share.

call Chris to final back the turn I'll over any Now Chris? for comments.

Chris Peetz

and change this data $XX.X the open million this our coming for through and through achieved we thanks, trajectory from months today. study commitments later questions. deliver top the in intend make net LIVMARLI year-to-date. continues key And in on and brings line the launches XXXX disease continued years $XX.X for we beyond Phase MARCH-PFIC operator, million Mirum U.S., line X joining and With opportunities us Europe look year, And our product development on we ahead as to over that, for growth build execute the LIVMARLI additional pipeline. of XX our quarter, pipeline as sales to in and and meaningful sets to Ian, the everyone, Thanks, potential first to close, several months. of this to on fronts announce in To all data rare approvals please we with with in

Operator

JPMorgan. [Operator from Jessica is first question Instructions] Fye with Our

Your line open. is

Jessica Fye

to existing do going or Thanks question. MARCH-PFIC into LIVMARLI they severe. in Nice within data the - might you the Where for broadening patients? patient going moderate relative Phase Is looking initially be forward? thinking to we results it in from most new launch. reads on from, that to LIVMARLI to think deeper more in data out, for when more Europe patients set from And PFIC? guys. going Bylvay started comparison taking particular this the Maybe quarter. average physicians come going you lastly, X And the Albireo's in Hi, if price to expect should their the are come prescribers about U.S.? the adds in what to you data then achieve How Europe in about

Chris Peetz

to turn Thanks touch Peter back then we'll and topics, Jess. commercial on to the two data. I'll for it those question, circle PFIC over on the

Peter Radovich

Jess. Thanks question, for the

with with States phenomenon United In to adds, A the comfort of the time gained predominantly it's some target extent, regards terms have be, growing know, we LIVMARLI. as growth And the newer expect to patients, lot into the to see note. to you primarily, There really to you as online them we latter maybe you prescribed over more think new lesser severely physicians where have affected populations. described. their well, patient accounts phenomenon prescriptions come but often kind our see a may patient in their former I initially, of of

in confident rare approval submission, In a of underpins value early to feel the LIVMARLI terms look disease and that proposition European other the specifics with price European really fundamentally towards achieve LIVMARLI's bit QX, and a par can it's as but on strong that in pricing, countries, get little kind probably medicines. of data the we into in

Chris Peetz

And back PFIC question. to circling the

lot the built saw tremendous looking overall, FDA already really we're led match effects points. for of - X analysis or to to the designation we comments, breakthrough study that's in with And Pam plan. Type the into analysis a X. some through touched opening the the Phase INDIGO You But PFIC that talked beat that of

Pam Vig

Yes. to that. just add And I would

totality rarity the endpoint think patients secondary I a looking in look we'll in of primary think In points. Key primary patients, the bile includes pruritus. when so I which mentioned, that's the on end then you well And and is we're the the because, then as the PFICX the methodology a endpoint largest primary as secondary been other XX enrolled. again what just of at number studied, is population study over step-down subtypes, endpoint study, the approach the significant look hierarchical pretty the population. really this serum acid. there's looking PFIC include at ever of about as as excited cohort we're then disease. And PFIC with it's PFICX, at all and which that's using at the the primary endpoints key of a the for Then

data to looking next of and come lot forward to quarter. that sharing really you a with So

Operator

Mani Foroohar question next is SVB. Our from with

is line Your open.

Lili Nsongo

had Good data. on Hi. is afternoon. behalf a Mani. on follow-up question Nsongo of just Lili I This PFIC the

would an anticipate upcoming provide you see, granularity more the differentiation timing First, assets? in to able at Should we be you And would of little we in presented data secondly, competitive that a data where terms the expect of medical from be presentation? may to meeting?

Chris Peetz

question, On for we than nothing Lili. timing, Thanks have specific more the QX.

We to will - be. too a plan the line which the one make share to that look that get early unblinding conduct top conference, I next think when we the sense. findings it would at would details one And to presented say and

differentiation. of terms In

from was clinical MARCH-PFIC more at with dose-ranging key I the these higher we you study, think X points Phase acid that clearing. across that, we're suggests as on using prior the in doses expect findings study the think LIVMARLI that the can we work the all bile about designed

then so response. into And better that should translate clinical

be response for we'll and So rates bile looking those acids compare see competitively. to serum how pruritus on

Operator

The Rahimi is Sandler. from question with next Piper Yasmeen

Your line is open.

Unidentified Analyst

Yas. for much on so my This [Lauren] for you question. taking Thank guys. Hi, is

to ready expect be get these put have an do And some Just data question then well. that And onto moved started the you you package second LIVMARLI? data into the on volixibat set? could What label? soon time as could XQXX why for will study the PFIC you to lines patients light you two And questions. shed about then then from warehouse One, outstanding XXXX? how to

Chris Peetz

expansion the with Great. start that And to PFIC timing when we speak follow-up turn of the thanks quickly. submit data other let Pam of the in for question. and questions. pipeline label I'll the in around we'll and then unblind look some for And QX, to relatively terms

in currently subsequent approvals And year. it well to data. of the to on mentioned, patients commercial for active the of eventually already for for rollover terms in reimbursements. Peter PFIC expect half through PFIC early based we'd eligible program, approvals XXX first get year, an in open globe access around and patients expanded geographies work that So nearly on get next And next once to globe have will around have reviews as drug be with available, those the that also we as we

for PFIC do So speak clinical about yes, Pam a will the road. rollover I'll active that the have down we parts to let very time in program be eligible lines.

Pam Vig

Yes.

So question. thanks for the

we're we the So study, that for And the VISTA which is the is the seeing label what patients on long-term open study, enrolling. of study. have PSC extension, we're phase

remain chain on frankly, issues. are And COVID as the so time what's across that still staffing from there's as hangover to industry, With great positive the been existing, that's shortages some seen that, really patients and slower think supply remaining typical regard pretty I a drug. well with start-ups, to - we some due sign, of lines,

kits lab with things - that and of all So like that.

and got - is, been are most the running. are and of are think, and that new screening. opening mitigated. of issues in now that We've of So now up these outside sites And patients being all centers I U.S.

So where to we're year. pretty and looking today feeling are data readout we that good forward about next

Operator

The next H.C. question Wainright. Ed from Arce is with

open. is line Your

Ed Arce

Great. Two for strong me. quarter. And on for taking congrats Thanks questions my questions. another

the $XX.X sales. million in Firstly, on LIVMARLI

if key come really And describe between deeper, your on of on are little growth. drivers then trials? working dig commercial from during to that secondly, what a you commercial to what those really in launch? then wanted rapid rollover programs? some view, are What, the far of as pre-commercial in so and other the is of the Just those could, as how that sort and to opposed many have naive a drug split drug that, patients is And to

Chris Peetz

kind of little uptake. for Thanks, what Great. the Peter bit the a of bit effective kind little in and Ed, and seeing we're of the being of question, take dynamic what's I'll the question. part speak a that on last to field and on I'll let

inventory on I is think our is numbers actual commercial to the pretty clear. given model, there no point first drug, make on in that patient current it

net by per quarter, just you drug that quarter. give the the translates if so which approximate to on what XX.X%, roughly per performance. see this sales, really is it's pretty And you last simple that using is that price So gauge divided what can about XXX patient our you we direction to from track patients net to we're

of in us kind were that very a XXX there that, Comparatively. is growth is U.S. about one larger U.S. in optimism for a access patients the the that had Alagille we the after program, gives with mentioned is that the ex the the and of of approval. terms minority out on let U.S. In of what But said, The really drug. in a talk the much we clinical about in thing U.S. And what rollover, I'll vast it expanded field. of bit prescribed majority patients seeing we're the than lot syndrome patients much Peter little

Peter Radovich

a a has quickly product few Thanks, approval. steady clinical from expected to you'll over patients can after symptomatic it. the they a And that Really start compliance, days, if high the time with products rapid Likewise, which It's been taking notice Yes. addition patients take feel trial. Chris. new like of you we as very benefit, LIVMARLI, forget it persistence which is for our consistent since well. what rates, really

discontinuation So compliance, very rate. persistence see very high and low we

quarter. patient together this that the final of adds, reimbursed mentioned add XX% our I'd the point dispenses phenomena, driving Maybe is is with growth. over we new those were last steady So what's really

payers the of seeing vast dispenses are online, majority come with that our the with happy really now paid. So and

Operator

from is Baird. with Skorney The Brian next question

open. line Your is

Unidentified Analyst

of taking to more in been in wanted the the compared in sales compared space, lagging just it's you're Alagille on Thanks Charlie of to the a Alagille. about Congrats I thinking potential PFIC on behind quarter. we've especially given guys. to kind you've seen get how magnitude for syndrome, of for question. how commercial terms color on Hi, doing been Brian today. little what in the

be about similar should from especially heard a prevalence So they I'd incidence and those, KOL, given, be thinking just curious rates. how you're that we've

be get on just it'd that. great So your thoughts to

Chris Peetz

from That's because the what hepatologists and that there. for see what much dig size is of some more with is kind it to pediatric this about talked in the syndrome. that that dynamics see, seeing is actually syndrome in patients, overall, X,XXX of What question. a see U.S. to we're these prescribers Charlie, likely couple and good we conversations Thanks, in Alagille in And - literature there's both Xx a Alagille and one of for PFIC of that common. to Xx as kids for we to X,XXX the overall, we the the GIs

the the bit and of syndrome of so recessive kind makes literature harder by geography dynamics it a of One precise to vary more does. some that much PFIC than is for does disorder, epidemiology be interesting that a Alagille little it is

kind you at where and there, where a syndrome you where is is may opposite see find out may there are very sees much who Alagille have several conversations, common PFIC a all. go they is state-dependent. as centers that of the patient often you Alagille mentioned or very KOL hardly and one what So have PFIC these you when patients, the city- of dynamic And patients number similar not

PFIC makes bit geography. by It So little numbers it harder a nail does down. to the vary

Operator

Seedhouse [Operator James. next from The Raymond is Steve Instructions] question with

Your open. line is

Ryan Deschner

you program. the reduction the only just Steve Ryan I on in also ICP outcome birth, this to a it's not but preterm Deschner importance if clinical demonstrate for is was think in pharmaeconomic Hi, importance the wondering possible Seedhouse. given

Chris Peetz

for on I'll jump the Ryan, Pam Thanks, this let in question. one.

Pam Vig

Yes.

the question. a Thanks it's great question. So for

I the think increased you're acids So at serum I when to serum think any the an risk fetus. literature in look increase elevated is on is alluding acids, you bile to what that bile

at the for one in we what ICP study, - OHANA are well. potentially so as those outcomes portion the secondary that in registrational also are we obviously, looking as end looking points of And is of our

would so in see outcomes. And bile hopefully acid to translate untoward those reduction therefore, you serum any that fetal

Part and untoward is portion that the pruritus, outcome, other FDA such be will also So serum the That's study. hopefully looking as obviously looking, we'll looking at most bile X fetal of at primary. near-term set outcomes. live then in acids, the be but But endpoint - events the

Operator

no I'll Chris further this to time. it We at turn have closing Peetz remarks. over for questions any

Chris Peetz

a Chris. thank everyone Thanks, Goodbye. great you - And for for Have today. joining evening.

Operator

Thank gentlemen, and concludes participating. call. for this conference Ladies today's you

You disconnect. may now

Mirum Pharmaceuticals (MIRM) 7 Aug 222022 Q2 Earnings call transcript