MIRM - Earnings call transcript Q4 2021 | Mirum Pharmaceuticals, Inc.

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Operator

Good afternoon and thank you for attending today's Mirum Pharmaceuticals fourth quarter business update call. My name is Amber and I will be moderator for today's call. [Operator Instructions]. It is now my pleasure to hand the conference over to our host, Ian Clements, CFO of Mirum Pharmaceuticals. Ian, please proceed.

Ian Clements

afternoon good and Amber everyone. Thanks to I fourth to Pharmaceuticals you and would year like quarter end Mirum call. welcome XXXX conference I Pam Vig. President our Chief Radovich today Chris our joined and R&D our Peter Operating and of head Peetz, Officer am CEO, by fourth Mirum XXXX. the and this results afternoon, announcing company's ended a issued Earlier full release year news the for quarter XX, December Investors and this filings can the news in website. release SEC section of our Copies found of be

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

Chris Peetz

cholestasis Community. remarks our mission will then joining is as life take Peter our start the people most treatment call provide company discuss pruritus us on highlights. need will Pam Ian. pipeline. remind rare touch the medicines And share a financial finally, families for It The has then turning to-date and the Alagille syndrome. indication life the for liver XXXX patients as significant brief milestones launch start, our in everyone a Alagille will questions. new we and launch a you, upcoming cover and off of and This and a diseases. pruritus impacts afternoon prepared the introduced and changing some to with for on of Today, will sleep very leading some and of for on treatment few devastating transplant. is burdensome and for point for to crucial deliver to effect our details launch we and LIVMARLI banner and these accomplishments for cholestatic Mirum a Thank Syndrome To like marked And good a syndrome. to Ian was Alagille of patients. I'd LIVMARLI today. daily year The both strong

with our survival event at the Lancet presentations potential label free and launch our and clinical show The the AASLD long-term data breaking recognized of of clinical at impact with last six survival. was dedicated LIVMARLI. year of data free in and hard of great years the is leading transplant of tremendous the experience treatment The team Our LIVMARLI And dataset success. late to strength looking the work

continue net be strength $XX year expect we in full year. XXXX million. quarter of quarter million product the We to And product first fourth pleased are revenue least revenue net we far the least XXXX, be throughout what report on anticipate to so seeing to to million. and $X $X.X we're Based the at at

view confirms be total million syndrome in the a And in than opportunity the of alone. to the market more in our Alagille early the overall this. estimate As we reminder, experience $XXX U.S.

reach. to U.S. We a with have built only Mirum compelling business opportunities but based the be not on global

grow. to continues U.S. the As

LIVMARLI for grant partner Europe the later patent coverage we've book and Also business, today announced into and built year, the be serve. additional XXXX We next all beyond Building our markets and listing the this XXXX. over with readouts in patients five we an further expect year remarkable two expected in value the the we across clinical a have truly XXXX. Mirum with to exciting of expect into of short, protecting LIVMARLI U.S. in programs to we data for calendar see years. commercialization, we order And approvals the in

turn to I'll launch that, with Now an Peter Peter? it our provide who will on progress. LIVMARLI over update

Peter Radovich

Thanks, Chris.

further we're of medication LIVMARLI, of proud only so for our in approved We this launch seeing share are our from growth disease. million FDA about the what I'll we're net X.X excited the first business, trajectory. LIVMARLI and the a and why initial color the about Today revenue, results commercial

note And by performance Thus, our recognized And of sales. of proportion quarter increase is when and the in First, drug. receives no dispenses that to it's XXXX. strong believe market XX% were access in of in patient is fourth expect reimbursed inventory in XX% year-end. the track by exceeded already is happen seeing revenue we're a dispenses first number towards demand. is fact, Revenue approximately will the product there of the important representation Also, which indicative our this of throughout our team. to expectations reported reimbursed, reimbursed expenses quarter. being we We the true approximately

the strong launch. by stellar pleased of to ingenuity a brought result success are with Mirum product and experience We execution passion, who profile, this very attribute as both this as entire LIVMARLI’s and amount team our tremendous to well

Looking and refill the level breadth by setting. very of of in evidenced believe the to-date. has the we high by as benefits who compliance of ahead, United treatment physicians encouraged of we're growth have LIVMARLI commercial the awareness rates treatment the seeing LIVMARLI, significant high States. LIVMARLI in prescribed We're Encouragingly, potential

hearing further Program, to based are family highly to which rapid and this LIVMARLI's Mirum caregivers robust adherence. the improvement feedback symptomatic is maximize Access designed our We in from enable of we and long-term expected patient Plus is disease. both support by physicians symptomatic This this on treatment and enhanced

of looking revenue at million of expect XXXX to this sales. at LIVMARLI least at putting LIVMARLI So we year, net $X product least the net quarter we're And all for full us confidence gives the seeing dynamics business, in year. first XX the achieve strong million the start together be we'll the in

launches, Turning to suffering year. approval Europe, patients early Europe this LIVMARLI’s plans in the bringing excellent around in we other seven making for of LIVMARLI markets. we And Alagille our initiating our access the remain European programs international have world. on outside commercial commercialization Western and syndrome for fourth And begun are progress from towards track quarter partners of to markets international

we've revenue XXXX by In as in online. both value markets international we in launch to a growth, engagements well proposition. success high pipeline. pre-launch and receptivity South an growth as I'll believe revealed share and fact, United to the in Pharma our GC like healthcare syndrome, are on we're international well also medical professionals markets revenue partner in unmet payers provide Alagille States, States, to in the strong come filed to XXXX And much update that excited And what United seen in beyond over Plus, need LIVMARLI recently addition in positioned LIVMARLI’s we Korea. it to hand driven the as our now for Pam with

Pamela Vig

highlighting late Lancet relief on presentations scientific breaking event rapid LIVMARLI as efforts XXXX, survival, data showing as an from first Thanks, has we reinforced identifying groundbreaking syndrome, is And by and survival. the our huge symptomatic where finish at transplant LIVMARLI, the a for research free the and markers syndrome. analyses, we of AASLD in presented have academics committed these free Alagille to in belief expanding knowledge Alagille publication And LIVMARLI improved predictive our our for our continue step data outstanding as collaboration. sustained free forward remain by worldwide with Peter. pivotal well two event to six-year that provided have study been we It a and patients followed and

PFIC Phase expect completed to in that we're quarter Now recently have front, data the fourth we the we announced of X on this in MARCH study, enrollment our top-line year. excited have and

As a clinical MARCH-PFIC patients previously PFIC than X and the reminder, largest subtypes enrolled higher conducted, enrolled with study in randomized than Phase ever XX is trial study. all the tested doses at PFIC the more

the achievement the size PFIC a remarkable is population. this Now, of given

we're Lastly, have with international that for eligible opened access patients we pleased an program share to PFIC. extended

and volixibat intrahepatic from with our data Vantage cholestasis Phase as targeting Phase Xb with study for with with interim primary children from milestones One second Mirum's we're two analyses from indications volixibat in as Phase and study patients XXXX, four several adults LIVMARLI expecting evaluating Now, we're primary ahead. Xb our Xb inpatients in both sclerosing have program. XXXX, In cholestasis volixibat OHANA biliary biliary addressing of EMBARK pipeline a evaluating other our we with adults for data study evaluating from study children Phase in primary cholangitis atresia. our VISTAS Xb from pregnancy. well In our interim cholangitis

and Now, us all note, position as call turn Ian. R&D well a Ian? in I of over that research the our puts on upcoming these robust continued to efforts, for as great will milestones, growth. And pipeline

Ian Clements

Thanks, a Pam. XX-K few out the of highlights issued I and financial filed release provide The here. a full today and press will call update.

$XX.X revenues we total South number recorded to In bringing of $XX in the net in our revenue our discussed, China, to licensing and million addition the Korea million revenue $X.X product million year. for from partners

milestones few the million. Of quarter And in approval $XXX of the and of agreement of will presence not costs for continue points million last the option Mirum expenses announced of review we and top-line $XX.X LIVMARLI, were the also research related with regulatory to of progress position last of by program's multiple XXXX. granted the of This $XX.X SG&A and in of that strong of FDA Our $XXX.X expenses us a of recall our priority in growing critical $XXX.X XX, $XX.X well year cash, year. of to next funded. investments expense these total contribution our million, $XXX.X for the and vet commercial that into September U.S. and our sales the have sale cash includes fourth operating XXXX over expense the achieve To of expenses puts million, milestones million, clinical XXXX, close for we years. And which with from voucher development remains the expand ended cost million. year, million the include at equivalents million. note, November $X.X across December

So the that, any back call with for Chris? over final turn Chris comments, to I'll

Chris Peetz

everyone devastating made we to diseases. has today. as thank advance treatments for progress you, And you To continue Thank remarkable year to Mirum close this joining past rare Ian. for

by off LIVMARLI the energized Mirum our hearing patients. to as start least clinical pipeline of caregivers achieving and these a that This on net commercialization, a revenue million $XX on based for in are seeing the again and questions. team is us. having base syndrome impact at is early launch our confidence provide in line Our on product year. Alagille you is we're in for the stories Again, the will Thank we what of have great physicians days joining business late-stage tremendous matures. five Operator, open we programs for this please from

Operator

you. JPMorgan. Of line comes Instructions] question from course, thank Our first Jessica, is Jessica your Fye open. with now [Operator

Jessica Fye

taking Thanks afternoon. for good my guys, Hey questions.

can first, expectation underpin couple, and a in reimbursement of that million at quarter X sales dynamics through Just for the XXXX? you the your first least walk patient of

Chris Peetz

question. excited the seeing in for dynamics what underneath some of to Quite thanks speak days the let we're that and about early number. the Peter Yes,

Peter Radovich

the for thanks Yes, question, Jess.

revenue seeing really strong patient by noted adoption our the on net side, we're as So number.

at transparent to view think their that net The revenue inventory. our is the that providing important have patient net recognizes signing into here family revenue It's and is at house. for to happening doesn't I LIVMARLI number we're really a actually level in but model. what's distribution be countered it's draft the note

down reimbursement come the payers, And what's with XX% line kind that the getting it's as clinical year reimbursed. is having there allowing been broad. labeling, on really we've early line of reflection of several happening coverage there. of big with last and educating come physicians year, And to have in by those you and we've we've I So kind into on think the is is end giving our year, of in of really labeling, a dispenses which with of from side, of to of expect, seen are the us direct with where discussions, the plans very burden just this pleased a what to syndrome, use that kind gotten view Alagille direct LIVMARLI out of we've policies we the this

Jessica Fye

there were in launch do patients that much a access? LIVMARLI current many get And use to how little talk follow-ups, of approved Couple more how expanded Okay. And the you [indiscernible] you expect program on the the access for bit in about decision previously context expanded patients? PFIC setting? can to of

Chris Peetz

take and that briefly more expanded And Peter. access Jess pass point I'll the syndrome. it's here access on important Alagille over Well, than expanded the to PFIC program, then PFIC it keep is mind question. thanks for in the rare

we is not patients coming So expect we've see as in available. that also countries to total. into is where as there seen, to response are not don't universal, But many that many build. And

is demand for. we're So seeing there still a need that unmet

Peter Radovich

And Alagille prescriptions. of access X.X number, of that the driven have in the over actually thanks to rolled majority novo all in QX, was though, on the de Alagille commercial we the note Important patients U.S. side, revenue the that to drug. million net expanded by

We've by encouraged the seeing. as we've broad we and real of across or accounts really really think broad that's the majority by from prescribing just base EAP the clinical prescriber our launched, So XXX prescriptions, that. a is which of we're seen minority so of really And driven new indicator health. participation rollovers, the and key the

Jessica Fye

Great. one, what you And elaborate just on new covers? a XXX the can last patent

Chris Peetz

Yes.

to So, that covers just book. briefly, in grants the listed the and use quite And the excited Alagille see syndrome LIVMARLI label orange at and of dose. I'm get it

Operator

Thank you, Jessica.

Mani from your with comes Securities. Mani, question open. line now next SVB Foroohar Our is

Mani Foroohar

having. for thanks progress. all Hey, Congratulations the on

So if Or is the that modeling product is for in partners from Japanese, And you relative a think it it adjusted will we sales million the that for then net do cetera in XX think should this correctly, sales? et about proportional modeling there? will Or quarter I'm U.S. right we the to year, is how like way exclusively be, how your probably X be say as any coming secondarily, there European, and you that? about lumpy? sales, revenue be expect to licensing should hearing

Peter Radovich

Mani. question with first start the can I

and you is commercial expect be excited markets, access year. really substantially revenue will mean While we XXXX LIVMARLI about coming mentioned, really And programs what international I revenue about are be from these sustained over the as international launching beyond of growth of U.S. time. all the but early in can to XXXX in some the this launches think and small that we very for that should

Chris Peetz

business and from that's round business to talked some there that so relatively it the that the the on we be Yes. licensing And just out modest but from contribution eight front, them, will exclusively. XX compared U.S. to about, U.S. the

Mani Foroohar

Okay.

the some kind what And the the of me I'm hearing expect revenue one quarter, you number already for prescriptions X patient suggests adds into the number suggest a slow which all of million is so now new hand. that baked quarter have that to from would represents that incremental? patients also of end it around Is that would and that the of is between in assumption there proportion, some or

Chris Peetz

that we So the is well. modest business those does seeing the language, some to way we're in in -- in what to days. really we're at it some the in here growth we're look your of give transparency But which looking early in at what sense numbers floor some of assume a seeing we're strong trying is and of that business, prescriptions these as is,

here So trying kind we in really the to numbers. of hitting year, today, those on where from stand already early comfortable communicate

Operator

Mani. you, Thank

Our your with next open. Steve, Seedhouse Raymond Steve James. line now is question comes from

Ryan Deschner

you if split guys, Steve interesting is accounts between Wondered more accounts gives far. Ryan on detail prescriber LIVMARLI Seedhouse. this small any the Deschner for prescription on super so volume little for and Hi, a large

Chris Peetz

Thanks, one. I'll pass answer over that to to Ryan. Peter

Peter Radovich

we've biggest prescribed. board. also of seen seen at children’s of adopters, We've seen actually really kind the from the be been Thanks, the prescriptions early children's programs in Yes. that now and country, hospital community, regional It's we Ryan. We've some across encouraging.

our So a participation it's broad from been across prescriber base.

Ryan Deschner

of very just you quick, so also duration Thank treatment real far? much. comment you seeing that And can then on you're the

Peter Radovich

here, the Yes. think, see month. kind know, our that as we what the LIVMARLI one really, a That's, drivers very occurring really real cases. predictable hearing the one on tried of of very remarks, we're we major every is get kind in after just feedback happening predictable one of of from I able to the the, positive refills robust that's improvement quickly seeing is we're to strengths are caregivers cadence And really which on rapid of refills of initiating, and those and with they're physicians is, very symptomatic you to a a think, prepared

Operator

Thank you, Ryan.

open. next comes H.C. is line with now question your Ed, Our from Ed Arce Wainwright.

Ed Arce

Three the progress for for on taking Congrats here. me. Thanks Great. early my questions. questions

Firstly, you've on been XX% year. already of this the targeting you're XX% reimbursement reimbursement, the and of reimbursed by drug noted rate end has dispensed

throughout through commentary What just accounts. I need walk your improves to Firstly, happen us walk XXX of kind penetration you of think the Secondly, so process physicians, the process? things that across targeted and year. that particular kind key just said as the around through

Just stands it writing thinking expanding then hands of time have you in first lastly, the year. Thanks see you helpful, so it would much. just this some if the more now about takes detail drug that be metric throughout around where it patients. And the to this and how script between

Chris Peetz

Great, thanks.

So through shops. all those Peter to, walk are in it pass I'll over them. Peter

Peter Radovich

Thanks questions, for Sure. Sure. Ed. the

going reimbursement take dispenses reimbursed. the year of on being entering get of to with yes, XX% what to the to So it's kind

mentioned of from high-quality way end those either the to I've to The seen really coverage. that ensure drug literature much they'll LIVMARLI the or favorable step the a then, policy get very and pathways plans we And a of that's reimbursed. Alagille categories exceptions. write By the U.S. FDA. XXX% like is aligned we ensuring been reimbursable life labeling of evidence had bigger first And reimbursed. pathway mental will two the a step to with the have to handle through very by Generally in next this the we've the far disease plan of have kind that's place in just expect rare kind policies and in QX for a after get that of is so the the of

there access kind really hub are and Alagille pathway those those the of really pay is through pull our all is now dispenses. in next So to step the U.S. to patients quality have of ensuring the a working we that for

So that's reimbursement side. really needs on happen the what to

your think kind I question second about penetration. was of

pattern prescribed -- prescribed, the we're of kind the that to seen a comfort hasn't the gain is in accounts of often then we experience sort it of prescribe it will phenotypically just to wasn't you those LIVMARLI a significant have expand XXX have that physician before two We kind trial. with going up based kind new is one on unfolds most what number maybe can days of of as that the ask medicine early or see kind of observing accounts. of pattern in initial patients that expansion usually severe And their

some go well. seen we've we're on the to at cases, other we where So be seeing out. fill those average. of from that's work days obviously, average but to through prescription and we And finally, In longer with that there that. time as to as hope to fast continue that's the a prescription on fast playing as And we're we received happy as to couple kind something you a some weeks dynamics out of really see in about fill, how year, there, really being really, then asked go than able it's cases,

Operator

Ed. you, Thank

from comes open. Schimmer next your Josh Evercore. with line is Josh, Our question now

Josh Schimmer

so the question. much Thanks taking for

be you later on for the we indication looking year. about that X approvable sense can Phase interim Just analysis for for to do give Thanks. endpoints a think are of likely be? the what What us in should this one maybe ICP looks

Chris Peetz

Pam will I let that. Josh. Thanks, answer

Pamela Vig

the Yes, question. thanks, Josh, for

is we So know for approvable the ICP, endpoints FDA pruritus.

very that, targeting the only a there's not acids. it's acids, to of setting. well and bile little have harm but so bile pruritus, different bit elevated also, as serum elevated And fetus disease serum a women These with as but

micromoles we bile that on acid is the front, in liter, per increase so to risk increased that And know every an serum fetus.

meaningful we those see for serum any in our be acids for setting going acids reductions fetus. in frankly, in so obviously, is bile And bile And meaningful that serum this to pruritus. the reduction will be

So forward later this we interim that and looking reporting expect to open out. year data label

Operator

Josh. Thank you,

Our Brian Brian, next with question now Baird. comes line is open. your from Skorney

Unidentified Analyst

Brian. for taking on Luke question. Thanks is this Hi, for the

you and there meaningful edge level the as readout. observed the Can then primary serum us empowering on For is could endpoint? on believe MARCH-PFIC pruritis reduction remind that of advantage the the And a follower improvement of space? you a bile a acid provide in commercial assumptions

Chris Peetz

set the data empowering. Thanks question. we're expectations what for Great. Pam about I on let for some thinking will

Pamela Vig

Yes.

So to X study, Phase with MARCH-PFIC regard really study about this that. now, excited

PFIC much what As important that the to we've in INDIGO subtypes. study, study across patients mentioned, study doses an I if recall, was rate X in think going of previously a you all And really we've we study. in enrolled Phase increased our is higher got this done dose in And had we doubled, XX factor are the than response. that when

that increased looking response reported data And later about so reading we'll else higher for and really top-line there. then, be so excited I see to year. what anything data we're doses, out. forward even is subtypes. And PFIC that'll know don't add But And that across that to we're out that's rate yes, with this hoping

Chris Peetz

you? that the Does question for cover

Unidentified Analyst

Thanks. Yes.

Operator

Thank Brian. you,

from your is line comes question Rahimi Sandler. next Yasmeen Our Yasmeen, now Piper with open.

Yasmeen Rahimi

back to I you're any especially label VISTAS that taking to actually sort OHONO XXXX. quantify quarter really it really Can MARCH-PFIC the and And Like, regards fourth off. that are or data seeing for of coming in than to real top-line is is both of for half my not for thanks do few just and that diseases? extent fourth of the that you're really can? that it you question. expected. the thank back roll filled start other first us the in describing we the I to on on then, Two, And readouts, matrix in well team, quarter compliance off PFIC my how can taking third you. the timeline scripts as the the world maybe one kind other first rate which you comfortable to the you due being guess, Hi, comment one seeing cholestasis provide or get Maybe have in could again the is color be some the fourth questions. gives notified, you data as some we're comfort in Like, that into this in push two for that going quarter. is if

Chris Peetz

the for timing. to couple will thanks Pam Yes, I speak -- the ask the questions. and to then on first touch March for looks about

I think first really off it's on label, insignificant.

So so view on longer and that. more to notable in And a highlight term of it this it'd as number of compliance, label think clinical we're relevant and an put prescriptions. get have not be we that we follow think any supportive. off see of in Similar it's the strikingly get our seeing you the more we of It's what seeing But we're early We far, really it six it's launch that's further a years treatment. actual says to launch. when what in, I up premature.

So year, on compliance real timing. expect we And throughout pipeline let that the highlight in the early a supporting year be Pam and speak and to persistence that full numbers. success

Pamela Vig

the Yes. question. Thanks, Yas for

about our programs. looks excited there. I'll really So start about

study we've they're and the year. be into on later rolling an VISTAS drugs. expected staying PBC interim far First what is And are that data will on of patients so the this and the analysis extension long-term seen portion study

effect of share later that study excited view year. strong really that data this the as to we So and a signal

setting. For data making as ICP, enrollment XXXX. operational the of to needed. have those is address completed and adjustments the by we we to and forward for you backdrop but as side, as Phase And on And working this necessary MARCH-PFIC continue challenges in X protocol There to are study. PBC, COVID the this on expected imagine push for pregnancy, can interim some in adjustments enrollment we're

so is be can a wind it's primary top-line data year. certainly six-month and So endpoint. shared you done forward, the clock this Enrollment will

Operator

this questions time. no There you, currently at additional are Thank Yasmeen. waiting

the Peetz back pass additional to Chris So remarks. I'll any conference over for

Chris Peetz

Great, operator. thank thanks you for everyone And joining.

We'll our important talk makes support Your advancement Goodbye. the next you quarter. possible. of medicines with

Operator

Pharmaceuticals call. the your Thank Mirum concludes for That you business update QX patience.

You disconnect may lines. your now

Mirum Pharmaceuticals (MIRM) 10 Mar 222021 Q4 Earnings call transcript