MDGL - Earnings call transcript Q3 2024 | Madrigal Pharmaceuticals, Inc.

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Operator

Good day, and thank you for standing by. Welcome to Madrigal Pharmaceuticals Third Quarter 2024 Earnings Conference Call. [Operator Instructions] As a reminder, today's conference call is being recorded. I'd like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahead.

Tina Ventura

Marvin. you, Thank and Madrigal's everyone, for us joining Good quarter thank XXXX discuss third earnings. to morning, you We issued post a slide press website release this morning call. the accompanies Relations of webcast, right Investor after deck and this which the we'll on section our that have a

the me questions. and remarks, Bill then take your today On Sibold, and Officer; prepared Executive call will Chief Dier, provide with Mardi Financial is Chief Officer. They we'll

X, filings Slide XX Our will goal refer today's the keep certain results note, from forward-looking over statements be risks we is discussion Bill to Slide forward-looking call to making turn the actual call to the statements. With minutes. Please you on X. about may to for to today. I of that, cause now on differ that We our a SEC will

William Sibold

thanks, call Well, on topics for Good thanks and Tina. cover joining. X I'll morning, this morning. our

First, launch. Rezdiffra an on update the

treatment we've long-term And see time. landscape trial. the over how in position our leadership to Second, made enrollment cirrhosis NASH, including OUTCOMES NASH we of evolving completing progress strengthen the third, our

Rezdiffra the start launch U.S. on Slide with Let's X.

recognize sales. confidence the we're prescribers to to announced was also to and continues efforts in high quarter feedback expected release from in our net improved we strong week system X be They're across patient the hearing the pill while to reinforces we're as once and standard to other medicine we morning, in an Rezdiffra all still great phase, another X care, to in as we've its quarter, low world range. prescribe are easier growth for the the and real gives with their finding by at end the we Healthcare secured. They positive. tracking reinforcing into date. it continuing of blockbuster X NASH. the key performance foundational is generating are patients to strong launch This have launch wire providers progress positive of access to that us an confidence performance million launch with see specialty metrics. to our Rezdiffra's very beginning launches. in this therapy position Rezdiffra our And inventory exceptional a demand the in $XX now experiences months best-in-class line early As delivered earnings as for Rezdiffra well-tolerated day This expectations our effective, We're thanks supported

patients. So with let's start

patients crucial patients with reminder, greater we're to patients with the a NASH the advanced with quarter the of are than diagnosed By As funnel on and most often metric launch the X,XXX more of early or focused comparison, XXX,XXX The second X,XXX moderate Rezdiffra. quarters figure We patients ended on the future the fibrosis. represents we of quarter rigorous a on to success. Rezdiffra. We bottom measure. the with that know drug patient ended predictive on than and

of launches. quarters, are pace medicine initial the patient tracking including metrics, tier adds our these During specialty against group a closely we top of

We a those adding are at consistent patients with rate steadily benchmarks.

have the trending dedicated with by we work, encouraged their our patient our to field takes or teams support the we goal time achieved significant quarter, last effort made X-month to outstanding reduce also XX to progress discussed prescriptions we As with Thanks filled. for time-to-fill less. We're payers. days with be it and at we've

do tests, covered not with of NITs, of XX% in current schedule. and or ahead commercial to more and XX% a the of during coverage by lives secure accept biopsy, than objectives At lives Notably, XX% a goal have standard than commercial in coverage greater require of achieved quarter lives we of for third full for was end, line care. quarter Rezdiffra Rezdiffra. pre-launch One non-invasive ambitious our place quarter, year-end, of this

patients aligned we access Medicaid with coverage Medicare requirements patients of This Rezdiffra July with prior has our to year. Currently, last label. and January exception Rezdiffra. As to X authorization Medicare process allowing been the process as was X accessing quarter, begin smooth, next of on expect in coverage are place we through noted medical readily

We start list would favorable expect Rezdiffra and to expect in many XXXX, Medicare this to plans access continue. to

Our about at XX% to other business our XX%, XX%. with has been commercial and to at mix with running Medicaid at XX% in expectations, line and XX% Medicare

on Moving to prescribers.

the top patients. a primary majority reminder, The the a These who total As on diagnosed and FX, prescribed successful have the any progress of targets with Rezdiffra, and to penetration XX,XXX the XX% of quarter. breadth FX goal X,XXX. both expand the hepatologists the depth launch prescribing, both third fronts. In quarter, include focus the our we top from with treat of doubling strong and is targets XX% on gastroenterologists rate we're XXX,XXX second making around

targets, continuing right prescribers are targets that look giving we as efforts. to written high all write fantastic we of among or with top targeting to of exceeding we're the our expectations. seeing top increasing are number at our prescriptions Our start with prescriber XX% is metrics well. The our as Rezdiffra of off a confidence our launch us depth an more meeting And than per prescriptions, either

by had market noted where driven to is built a from as the be has a the written to in Rezdiffra's up. success the for Slide needs Our ability never date This there wire been on NASH. also March, ground Prior prescription approval to our system, to X. to launch first-in-disease been continue

our that to strong been develop processes will clinical establish Our has and support goal for practice prescription and expectations. changes in sales patient a efficient to peak drive foundation flow

made success has a the progress NASH have here in successful by most been which leadership thus industry. key the our of strong care and far recognized A specialty has payers us proposition, patients. terrific factor Rezdiffra's providers, to launches date. one lot of been value Success achieve health allows position have work of strengthen to left our we do, to and still we While in

fibrosis high safety. It's efficacy resolution and bar set medicine improvement. a Phase the As and Rezdiffra liver-directed to in a that on both only results statistically is significant reminder, III, for achieve medicine has a NASH endpoints

entrant more foundational these or than from Importantly, believe year profile new liver It's patients that to should stay XX% It's the will line that's clear that stopped a medicine class. other for real-world to competition profile It's in therapy. once-a-day improved patients in sustainable well GLP-X provide well-tolerated suggest fibrosis. We for after allow this potential NASH pill dosing. be patients when from the simple of favorable the on The Rezdiffra with emerges. over with this moderate oral way X that strong well medicines. becoming persistency tolerated of indicators is advantage advanced a results its on Rezdiffra fibrosis time. Early Rezdiffra to with therapy could product next

look the semaglutide at As Rezdiffra on profile X, across see Slide that you'll compares very we of attributes. key favorably

to term. Importantly, the a treatment real world struggle more stay long on GLP-X in taking patients

In fact, given on shows is data NASH XX of year, weeks. patients study remained about is XX% that especially with only important obesity X their semaglutide which after

that with time is his will steps be NASH cirrhosis, For want moderate or fibrosis advanced to patient to are to providers X patients consistently her confident take to who X care over having away medicine an their health from see going effect. or

will consider and believe a for impact we further launch the ahead market the X, Slide Rezdiffra. look opportunity on of accelerate on GLP-X potential the as it growth So we

a semaglutide. And market, benefit of importantly, advanced fibrosis. Rezdiffra, therapy significant attractive And patient treatment. Novo awareness, larger the in are in both mechanisms increasing its early this large will is for population patients this much on there moderate to is room specialty focused are XXX,XXX challenging and overall rate the patients the on clearly also diagnosed market, discontinuation will from efforts with most diagnosis benefit by NASH On and still our the own, is this as NASH those to focused the for multiples in and treat and treatment. expansion underpenetrated disease. NASH with first-line patients X% with high multiple undiagnosed Nordisk and this market screening, foundational on many expand of and Their both We diagnosed of an we patients, of XXX,XXX. journey patients

combination therapy to be expect the part treatment paradigm. We of

it's percentage comorbidities, ahead. We're that combination treat Rezdiffra patients continue XX% in the Rezdiffra fact, EMA higher Slide including beyond a when Approximately using new U.S., potential potential expansion today to in are the Europe, competition, much additional approval. the our strong pursuing GLP-Xs launch their preparing patients the happening. market likely In of growth already of growth is with that and Rezdiffra as This we with Rezdiffra on to penetrate opportunity we half future continue the summary, 'XX dynamics. about second our X. in highlighted be the pending for are in and launch also we have for of target profile, GLP-X. In significant market Rezdiffra on opportunities previously optimistic market that significant to real-world our beyond where XXX,XXX a years efforts Between been to Rezdiffra's confident are deliver for can includes attractive

Additionally, for are compensated milestone patients results outcomes. regulatory bring cirrhosis. Cirrhosis first patients to risk completed cirrhosis. progressing Madrigal liver-related the to benefits we're approval, month, could MAESTRO-NASH NASH significant in Rezdiffra make with working we in to for field. Earlier of a a enrollment to this at trial, NASH patients NASH OUTCOMES Subject medicine with marking Rezdiffra's the our positive high serious

for OUTCOMES This R&D to NASH ahead further cirrhosis as portion patients in While competition. I'd NASH. MAESTRO-NASH position well Michael also XXx stark greater or that our Dr. Charlton underscores in with trial a in providing the in very the X our risk has organization cirrhosis developments urgent us of patients could our as exciting joined highlight data patients patients well as trial Head Clinical FX XXx in in OUTCOMES Development. need with FX the approved have like FX, this that liver-related population. Results vulnerable of an as data effective in is of strengthen only therapy decade, Rezdiffra this from in years treatment mortality, to leadership of XX us FX, FX the statistic higher. risk our OUTCOMES

As the Madrigal a company. a world-renowned expert are we in for such he time thrilled to join decided pivotal at NASH,

in the where AASLD presence approved San as science. advance spotlight are a for the is therapy be Diego, we preparing mid-November for Secondly, first NASH. Madrigal field will the strong Liver in Rezdiffra the to the in ever NASH at upcoming leading Meeting

therapy NASH Clinicians as NASH from produced initiation support similar have than documents resmetirom patient other AASLD foundational now program for the June and guidance Rezdiffra's identification, following abstracts July. released recommendations reinforces expert that recently in role panel the EASL the Moreover, guidance at multiple monitoring. treatment Our AASLD development in any to more guidelines program. and

Before let on our it Slide over XX. progress I me summarize briefly to hand Mardi,

ahead NASH of of driven Rezdiffra, our on patients quarter achieving first by of prescribing breadth lives continue significant more And This approval. With meeting closer the pending than our The step one sales trial, are to results, $XX second and bringing quarter, both in we're of to opportunity that, we market patient ambitious to than covered, Rezdiffra, half schedule. About with to depth Rezdiffra therapy strong or for I'll in exceeding X,XXX milestone and turn targets. XX% greater of outstanding commercial of delivered ahead. this million cirrhosis Mardi. population. launch well enrollment our vulnerable targets it XX% tracking to outcomes we a Europe EMA Net this top the demand, completed full drive XXXX over

Mardi Dier

we -- Thank financial our with results. you, Earlier issued full today, a our release Bill. press final

third So sales I for as noted Slide of the highlights few the a you on net XXXX, of U.S. quarter will $XX totaled XX. provide million. quarter

to expect inventory a X typical we to run previously, mentioned weeks X for medicine. is for Rezdiffra, between we've specialty which As

was Bill end inventory of with noted, another low strong demand at that the this quarter range. As

was third Our the anticipated our gross than to our favorable quarter co-pay as lower this quarter. again program to assistance was for utilization expectation net

compared be As of the particularly in to before, million net the quarter XXXX in launch. R&D expect gross to expenses the we've third $XX.X of said million were XXXX. we early third for to choppy $XX quarter-to-quarter, quarter

commercial year-over-year March. to were third SG&A stable to XXXX. in primarily R&D continue relatively expected U.S. million in year. the We operations this quarter anticipate This was to increase the Rezdiffra's approval $XXX.X our $XX.X last year of following the of for compared due expansion million expenses expenses to compared

our sheet. Turning balance to

XX, planned well cash billion marketable the and $X in securities. Tina. September U.S. and of the we to Rezdiffra equivalents, As turn are we call in support cash, both ongoing to the With had our this launch cash strong launch Europe. I'll over resourced restricted position, in back now of cash

Tina Ventura

Thanks, Mardi.

move the Q&A of the Let's into portion call.

for the instructions started. So provide Marvin, get the we'll please session, and Q&A

Operator

[Operator the Rahimi comes Instructions] of Yasin line Our from first Piper of question Sandler.

Yasmeen Rahimi

your what the us fourth sort really forecast talk XXXX? Congrats to quarter And growth guess, an Team, question about on jump are performance, or I'll you queue. maybe the could quarter, amazing forward back is, incredible. into into thoughts I into your of what and moving given strong around

William Sibold

how is prescribers, at indicator all strong We're progressing. Yes, thrilled off the launch as great on executing very said, quarters success. progress is coverage, adding a really important in levels, with early The we're trajectory launch team to I start. future patients. And for made really adding is an the

We for the well. see zone growth as in quarter other what growth, is have benchmarks like in we're typically last well in average. benchmarking own that benchmarks successes. against the the internal of at, launches we're And launches. really the XX% metrics look great ourselves metrics, tracking unmitigated looking launch these And at our you but we specialty on those And are XX These XX with on this. also great we're are that about years against doing third of

a off great we're to start. So

for comment Mardi, XXXX, to you that? maybe So want on

Mardi Dier

Yes, said, looking really quarter quarter, We're But provide can on for increase to our we're a fourth our absolutely. XXXX. some and to before we're plays points year fourth say we robust out more performance how of any third XXXX into look of we're pleased we and that expectations absolutely, what we view to off what and third we at But see Bill you XXXX start. specific strong fiscal on this that quarter quarter. with forward Like anticipate growth account to based would growth generating. is XXXX, want into

Tina Ventura

please. question, next Marvin,

Operator

Merle comes question next of the of UBS. Our Eliana line from

Eliana Merle

quarter. on the Congrats

terms cadence data, the whether your expectations then of a fibrosis are shows step you payers patients the the if GLP-X new starts in number strong very with benefit? seeing per patient seeing accelerating? And Or require of of data month? new will patients week new you're of what or just Are number curious ESSENCE for a ESSENCE terms starts. of the in Just through second, the what a similar is starts the

William Sibold

I appreciate question. the

said, we steadily continuing to So patients. yes, as add we have been

have -- a lot of there's We out interest there.

right? penetrated at have to physicians. We haven't yet all not we're remember, either, prescribing You steady state of the fully

So to take add baseline et to then get continue patient grow new longer that to progress wire in making to you system. that's But we And every perspective. your start you going cetera. the prescribers, from day, as adding we're patients, a new

we this pace -- expect to that's So continue.

Eliana Merle

and through ESSENCE GLP-X. around was question second the And step

William Sibold

Yes.

To as we're requirement for we Look, understand So look -- what we step-through. look want the to to results date, to see well. any try results, number know, thanks that a readouts questions on, of data the as really we're well. as little to because, always probe say. And bit to haven't says don't a line like for so seen -- into and doesn't translate have we're to really you waiting going well. when get labels the trying top deeper we'll what And

NASH treat the X.X following: how So therapeutic look handled? the biopsies the some are milligram What to intent even reach percent for results And do can the of be up in going in we're the you've that in matter. practice. because where about versus set trial end, really But for And we're higher as profiles result well-controlled I seen that. that's the trials. we're where really rate think response That's talking here the like are How looking patients discontinuations read, things of things dose? to are What a like? other real-world

of happens, So if happens we'll the with payers. the what trial happens with anything see results what to see

just we a are strong really what reinforce Now I will in position. is

payers had have now it They and the profile ongoing the of for year. a offer. what profile. dialogue over product We've a We can good well with understand very

any we go place into ESSENCE. a So in we takes very like readout that from strong position feel potential as we're

Tina Ventura

question, next please. Marvin, Great.

Operator

comes of of Our next Tewari question line Jefferies. the Akash from

Unknown Analyst

for This is Manoj in Akash.

the Just one. Why on you that could the Which patients? late-stage you outcomes, benefit patient trial these confident on expansion are definite more show like of hitting confident or are trial? in MAESTRO-NASH you FX a

William Sibold

both in confident we're Look, trials.

have we don't we yet have wait Of see what though, looks like. course, that and the to so answer

to for very we NAFLD-X we It in had we We based that label. went there's open the a seeing that a some of the cirrhosis on population. are trial of work reason may why good on trial, the XXX results in that there that the this Rezdiffra have -- group was cirrhosis patients feel

for been of as Rezdiffra referred regulator In fact, has master to fibrosis. kind the

front. that about, the we community we what So learnings in efforts. leader good through there's and learn a these that of that the about to ask think important this is question drive there's It's trial, something to leading to the a want course, out that science We're as to it's for chance be the cirrhosis We're we always the ton a overall. and do especially hit. We're, going community to that the know? of going think here We science. think, does something push

based the interest in question. the we we'll have what that see to So the the interested to upon significant But is cirrhosis answer in results know say. hearing community the trial, the really

about really You trial. and XXX interest that expectations the because we in patients that was the enrolled, had exceeding saw that of just

Tina Ventura

Marvin, please. question, next

Operator

Our from line Ritu the of next comes of TD question Baral Cowen.

Ritu Baral

X optimized XXXX the I because up program set you did said need things I you to with co-pay that would utilization logistics. And be -- Congratulations right use that's free to going guys satisfied guys the you program your talk ask being anyway. promote to of drug quarter, those offered, a I'm say, free this co-pay treating success? Can going say some free Medicare I guess, utilized, was number? in to on with into to We've that about Mardi, just the have little the commercial quarter. are think, about you just complain now heard you from the commercial around Medicare Do drug amount drug. to but discomfort, low doctors wanted I population, patients

William Sibold

all, last goods a there's little of little this perspective, First a bit little and would quarter, in we expect very quarter. of. That's was from very time, free utilization that something there more

So all about where not we at are. worried

As time is offer, progress how for the we're those relates of offerings. all you you're launching that community b, potential seeing a, it as the there, any they on to utilize do then know any some services new it But and out good things. takes what those to, product exactly

obligation. have. practices. keep have a it's we certainly they program on. have that have you them talking be more that access heard So and would and it something Haven't that feedback making sure commercial experience the and where the haven't of are the challenge the offerings service absolutely lot we it's cover it, can of for them know patients it. are the patients to I not want a an their towards to But utilization, practices spend deliver it's how only feedback, physicians expect of per that would I with heard to would they pay any pretty eye rest that providers. Co-pay of the that the $XX this for that for physicians Again, very say. we that we a And towards an practices, we it's been to best-in-class early month, for We best about that in directing issue but of it, that access we time directing good

expect time. we going that that, increase is So to in

take we've we've is access for launch any And time is well. affordability if through recall, done offered the patient product, an be will a possible Equitable PAP you to we emphasized on for that obligation. can we access fulfill including the keep get. very, that being We any very done a are program drug that's community, that means we've eye robust them, product. it been We've and patients a said find if patients. And as in seriously. to have other we affordable But it because program. will that free we patient patients. do way feedback to We assistance we this to co-pay a in we very needs important the fact, help we've of the way it. clear, want product, react through that very The as what In it want it is here. We for increase really we'll really quickly. And have get

it. specific as you where on up well. and eye if feedback happy an heard keep follow any talk And you we're them have we'll that, with to So from

Mardi Dier

to from our on script days. well filled, the drug seeing it's X-month Ritu, days goal which down in already XX XX we -- Just to what that achieved mentioned that we're bringing was from we've as mark, for prescription the that

much right very for the are us in things now. So working system

Tina Ventura

Great. Marvin, next please. question,

Operator

comes Our from Wolleben the of next of John line JMP. question

Unknown Analyst

want for GLP and Are this had I that a on Catherine happen for John. on you how are is Wegovy therapies therapies approved well? are what go will there? And payers question any informs NASH on is handling GLP about This to currently those or already sort seeing as of how if patients issues Rezdiffra.

William Sibold

Yes.

prescribed seeing are I GLP-X believe So been GLP-Xs right, And indicated look, I indications a Rezdiffra for. the that Wegovy, that we're and for think that patients estimation, about regarding comorbidity, are GLP-X. are on what our about has of that also a XX% from -- on

done are suggest some on have which up been GLP-X. of already or that either patients research, we've exposed to market XX% a Now, to could

you're world to that if has comorbidities. And has expect And been I that's be therapy been they getting treat GLP-X, an the for think FX to or to of may evaluating required to patient not. a Rezdiffra are they on we whether the have treat GLP-Xs may has a real as problem. here is of be continue on to or So NASH, a exposed reaching where FX, physician kind see regardless used who but if patient, they're they're patient when

give them exposed, for been patients already kind years. a used, of lot there they're us? XX% availability that is is not would of research of the market of sure. that what of if there's and have to still or future on many much I'm that glimpse say how But being out the are with So I the NASH a patients so does correct despite

evaluating is strong for for And like if X NASH. well a I extremely we're it evaluating, And for versus So somebody that think position. you're different things obesity we evaluating very that. feel you're in you're somebody we're positioned

Tina Ventura

Marvin, please. next question,

Operator

comes line question Chen Wolfe. of Our from next Andy the of

Unknown Analyst

This on Congrats the Andy. is on quarter. Emma for

Just drug your you provide another or then free following a about asked Bridge revenue a awareness. lot question across able to be from QX you program, question patient up revenue? speculate on the just recent campaign in whether utilization PAP? And us, to September a are they split on of Can versus raised QX can converted of

William Sibold

No. with and Great. a PAP, little Bridge the first. of Look, utilization so let me perspective just provide

have do product period if finalized we interim is we for their the patients insured So send -- to the the insurer. commercially a Bridge program have option in being with them while reimbursement

have said in you the want to Bridge use to when As -- program. you past, you decide a I've don't

this this since gates You a getting want in worked to And path way, to good Bridge have of assurance commercial to there's come may being lives one. In delayed product of now using reimbursement program. a time we case, insurance a not out. don't out it while with XX% the have is such patient of covered, a is

that's insurance we in this very similar and quarter, quarter, goods offered perspective, said good patients a were to very ability call is we few point. From the it said few And being of there's that we while out. free the I patients. have to broad what patients at again, last goods So worked start to free free program. wouldn't there utilization

that patients is relying indicator PAP. finding product very coverage an without to are path strong on to that a me, and that's So

the that demand using let really, And excited are time a free really increase. we People strong available. have patients, There's is that to expect on. very about it. But it. is it we're going is number patients This few about clear and However, quarter. really me be that, would in we

taking you done, asked Will turn the be that ultimately work to a and do action question is knowledgeable a of about campaign drive lot action. you of seems to and patients that's been comfortable there interest. being lot step into what first A have or the and of launch in patient the awareness. Now, It's ultimately physicians QX? some to taking patient the how

far of we have to in a we Well, much obviously, into it, that yes, patients translates is in piece our is So to see demand? role efforts that a efforts. How it our with did directly a to response but our so out -- of reach seen DTC hope, itself, plays it it. positive future

need to bring their diagnosis and to fulfillment have ready, and they You through pathway patients everything and through that of along from to the practices through still have prescription follow-up. prescription

So it's consider a I the of would that an stand-alone. a important effort component, but full making than piece rather we're it

Tina Ventura

Marvin, next question, please.

Operator

comes question Agrawal of Cantor next of Prakhar Fitzgerald. from the Our line

Prakhar Agrawal

Cantor. on from the here quarter. Congrats Prakhar great

first if end. is sales in my in reason seen imply a month-over-month maybe in low you add would whether and assuming XQ? steadier patient a is, So more adds lower is comment July saw adds question can inventory you on number the August, patient September? of the at And adds lot asking in XQ The linear I'm a

XQ? patient in XQ? new number. And month-on-month given seen trying seen follow-up, moderation on sequential trends again. growth be the as similar in just patient a you there would and some throughout reconcile the expect would Or So growth revenue XQ to Congrats the adds

William Sibold

cumulative and with adding ahead consistently week, look month to steadily we're We're adding that really, prescribers, the that. the October. and pretty through effect even the day, get as continued Look, and it's we each patients each you each and of uptake. very we're summer pleased And

quarter looking seeing So quarterly And not going month-to-month. what a We're on from from really you're it giving growth. little for perspective. a month be a of per the it not specifics -- because all a make strong give cumulative effect can is noisy at to I'm things those

the in the fourth we into quarter, And third dynamics had what that's we So the move quarter. remain. as

Mardi Dier

add listen Yes. during to Bill the And you back quarter that and fourth script, to Prakhar, I addressed go would that. if just want the

Tina Ventura

Marvin, right. next All please. Great. question,

Operator

Andrea next of question the Sachs. Our Goldman Newkirk of from line comes

Andrea Newkirk

think specifics or Congratulations we you're on been point versus referred you've quarter, forward benchmarks as been update there an love terms a that analogs been if looking here. focus how going prescribers wondering the here. to maybe as trajectory? And uptake drug would how going? of more the provide as on at, latter mentioned has quarter. a that But had you're to I of maybe know couple this the key times of hepatologists about little this the across here willing specifically then has last or in your which gastroenterologists. one a specialty Bill, the they bit are the majority to But your of

William Sibold

all are first-in-disease specialty XX say XX these we'll now. unmet give benchmarks over of look, in results, blockbuster results, mentioned, the see are the high for and need we metrics. that medicines medicines. But the last you look, our I own that against -- these with all So group we about and be They are I think first-in-class, to our well around performing years That's strong can areas. tend internal

of here for launches think board a and comparators. a in holding They're product, one the right here hobby. amongst team being we right picked not for market I best be think I I have high picked is really bar at They're looked as here the the to -- a that ourselves. The Rezdiffra, on industry. And create think win. we to we're a we the brought that

remarkable XX to in I January, been really of and a we've really, significance, commercial think in were if set in we period were can months not team had even goal actually, do XX we -- time. ago when even our of about we think able team, you you high. that done job, as a where place short what which isn't ago see, especially have we And where So the well, months has

We're lot So been launches, a with one I say lot the of job launches. doing top of a in at this to I pile. launch. have the of in great this put been involved a involved I've outstanding

a just bit little there. of So commentary

to and in a last obviously similar say little quarter, I but what by GIs. heps about bit So would progress groups. said I the both

If you the the think hepatologists There's the key. targeting, X,XXX physicians that is thousand about XX,XXX we're country. under a in really

the depth are lot kind growth of we've se do a steady is So seen volume by physicians, what you've of patients, both you just sheer numbers hepatologists. virtue breadth in by per more across groups. And gastroenterologists a where and of got of the than

That is doctors. of liver their are specialty. they organ hepatologists, the remember, Now

knew say, So I time, little bit they're faster a and bit a a liver little they've start. at looking little faster, been for average off the on they to disease, would long moving earlier, the bit because a

of the sheer And based overwhelming However, the of making the GIs number scripts will progress. the and just them. on majority, they're represent majority represent

little NASH Now, though, to They they to for how right? in alone have treat practices pathways bit a patients. start let patients, had process established from different NASH their space didn't

target that or Somewhere NASH, that target create the focused the interested target have are in enriched how that on pathways. in group prescribers. we've ones to They of these we're steps X,XXX in That's taken liver. population interested -- and

meeting et the a Now, meeting. points night cetera, time. were in Vancouver. I'll to difference. beginning steps Philadelphia, week pathways. the to was just taking give last X equipment. American acquire process And like treatment gastroenterology in the hiring and there NASH year And to form was ago, week, APPs, day create this Gastroenterology, were People of and College People meeting imaging their in steps people was taking in staff help knew of the drug, ACG, A of it or

everyone, you categorically forth. So pathways so which moving the have towards group but across whole target that and wasn't these creating is gastroenterology

understand of They're launch in to a -- months where shifting but each at process the that use, -- knowledge say, how of how relying we or remarkable training, heavily GIs therapy patient. need. really, X taken a are some NASH gives that more little I They practices GIs for of think quickly so, see creating really their of it it's time, it's their just the happy the in now to happening bit you and it's their are pretty foundational people And to towards color unmet because space. would just But out I on really a are ahead around it. future. that's right? So to quickly. available along But heps still throughout them their there's going be easy that's we're pathway So quickly, moving

Tina Ventura

next question, please. Great. Marvin,

Operator

question the comes from line next of Liisa Our Bayko of Evercore.

Liisa Bayko

one sort based of One Europe. types U.S. have X of I and is questions.

ones expect favorable net us assuming of diagnosed of provide you did this could of Any us you and Could data you're on with that can the patients those Europe, quarter? market, then and give seeing? you for positive, -- be said it the more choppy, fibrosis U.S. that result for was had numbers do where Europe? kind care. a from think little So color I as in you significant we about far net? you changes for U.S.-related on any know the question, a at thus of rate land in kind Mardi, semaglutide on gross way of then but gross to then that? And a lens And you of you and is give same the you looked would kind kind sort color discontinuation to as

William Sibold

a let the Europe Europe, move then say, to approved a gross product Great. get where the for net. to success what versus the with it's result, Europe they're for had were is, that is the will and Maybe U.S. I ago. Okay. They've is of that ahead was product Europe. do me interesting. year -- we back as of approved benefit on a start I'll knowing And in we'll would NASH. of kind planning

so And taking more action. they're

wire that I going taken in until exception and told calls XX how past meetings, to hadn't us kind the steps in about to meant over to it wasn't the with of March patients. they practices, started they're I speak, thinking physicians it. when a system, here process approval really that advance of of As they their so that they said few mean,

year was it advance different a that plan I that how for they indicator bit in approval, of little regimen. think first into plus is the guidelines this an would see a that of And is that treatment it. the if they the in came anticipating approval, the of approved, Europe out success the Rezdiffra, Now, in essentially EASL U.S. fit

in So we shape. they're good feel that really

the getting we are U.S. that's starting a to over those just but bit it had Now years in now, we obviously, been did going prevalent little We've in than for later, we're the medical there patients number that team the most in reason we're in think way. are there started look, do U.S. Europe a we're FX numbers efforts. The And opportunity in patient going very, there's approximate from NASH that that targeted FX, need. a of -- Europe is and are we very is

able As to of like, exactly back who targets and going focused, little closer doing leadership, an numbers very, more way. so be bit manner. better in and we assessment come the are, to you on little a to cetera, hiring of get well launch, very but give we're idea. et a what We're diligent we're patient look a the bit We're do give

We I they launches. are When planning Europe for will We've that recognize success. value. recognize We -- innovation. say still in think that seen other

So we're there. we're why progressing that's how there. going That's

you do U.S. want up to the net? Mardi, to maybe, gross So pick

Mardi Dier

And to in said. forward particularly as net we we absolutely. look gross quarters for additional to some gross do Yes, these And you're be choppy, as already early of net, can we've right, impacts, launch. expect

this keeps So we own and looking one in that patients that grow, is patients now as gross And to said do drug that We we And quarter already lower the of than on think co-pay biggest benefits our again more our the that, Bill was described. assistance to right forward. factors program. expectations. net want the slightly

there to can't a course. QX of see gross including typical on And will net, some et we So we dynamics XXXX, cetera. reops, that see the on co-pay changes, insurance assistance. I comment with we'll growth anticipate plan

the expect that other XXXX like to from gross we -- as pharma an IRA well QX we in net. So companies, impact

but step So XXXX, if just range in say typical will question NASH, for specialty range is back within to medicines. we up to specialty will is the approved your net gross bottom believe the line, go net the sema our gross of to that net in and gross specifically like I'll QX on and answer medicines. And that about sema really still that impact potential stay to within

William Sibold

like had pill you've And of in going was anything think a that that patients And sign. the day was number And beyond is is yes, question career, the kind a we're Holy this saw this. It's in strong kind persistency -- good presenting heard strong tend would far is clinical past that us again itself hearing to think The be say strong that product. And good profile but I once there persistency was X,XXX that's we're we a everything So net product oral a about were with -- hope that, have at number We from a really a over them to to really believe the And maybe, there Liisa, will profile. once think discontinuations. drug Look, -- -- day. is and it's of one Everyone patients. trials really And there this net quarter, heard gives pretty in so a we that like have been end forward. -- a that the this we've low. to really seeing mean, persistency. a thing, It discontinuations, be that's -- me in that still discontinuation say look going you everything. a of X,XXX, right? my discontinuations we've patients that's But persistency gave early, solution path is drug. Grail like wants optimistic. of the any this we asked on for some. the of we're of reason with

Tina Ventura

please. get try more question, in. couple a Marvin, to next We'll

Operator

Our next from line comes Jay Oppenheimer. the question Olson of of

Jay Olson

rate that Congrats expectations fibrosis for ESSENCE trial? Rezdiffra? for your clinical on And your the talk Can then about versus all And you endpoint the in event fibrosis the a the the for also driving is expectations? rate improvement improvement MAESTRO-NASH? benefit tracking And importance how progress. outcomes in of

William Sibold

to try a answer. lot to there There's

work Let start We're backwards. ESSENCE, I'll me not with sure.

haven't don't We data. We know. the seen

we hear sure top think like, look coming look like? happens do going an into categorized be what questions population to held it translate there's versus don't we'll I right? it's to said, what I are we many going that the perspective? also going want the discontinuations to when standard to becomes the ask, it's got handled? How that a As well. get patients Not from what results, understand. labels anyways dose? we're be present to always or as I you in line intent-to-treat How said, So the, answer. to few what's And what that going you're weeks There's a to dosing the labeling? So Top very regulatory

show, of in regardless what look, the we're So results position. strong really a

We said, a lot profile. We've is are drug. physicians I We've -- picking using on the that of that got patients momentum strong of have product very product are just as profile that up. a lot And a a drug. got

as to And talked going So regardless looks, and be effort try we like it a space. to of we on know how to we're the And there's well. about of prescribed by market of strong and that a number any call, a size are real so in forth. benefit in that feel to we position entrant we're the from patients as drive new that the

saying we to psoriasis And like to cirrhosis look think -- like. to Regarding population, had like. are really comment the ongoing, the this is that we said, try OUTCOMES Part population me, I'm on I monitor. help trial so about we educate understood -- This -- the really we're I trial, since do to of be the well the will would and so you able not OUTCOMES as -- event commented. event an about best cirrhosis look continue about understand the could pardon what to what what -- and and -- look if us think other measures outcomes we old rates And look habit used not trial, is that cirrhosis psoriasis going our community this forth. rates would that think that to like. And around is to ongoing we trial, haven't going event on trials what rates an

we're So awaiting. anxiously

monitoring update seeing what we're in outcomes more running we're obviously going -- we'll the now have of and not when that data, be we're the -- fully say frame. give a 'XX trial, look data, I to but we're time trial the excited that we to As like enrolled,

Tina Ventura

time question, for Marvin, more one that. queue Great. for if you could please,

Operator

Leerink Our of Thomas Smith from line Partners. comes next of the question

Thomas Smith

refill nice on as rates. development, just ask And BD think, if I'm able building you you're you're on when the you respect separately pretty continuing I opportunities? if you're then thinking preference quantify those days, Rezdiffra? brought have around potentially on launch wondering have about from able a persistence or to and know early of quarter. into numbers just Let to but adds. business beyond visibility potentially speak just me patient Dr. any a clearly that? And persistence notable. whether stage new development with I how wanted add and you is of Could patient here Charlton to drive my Any any sense to put you're I congrats early evaluating to having it's board, you'll be to out some pipeline of still

William Sibold

it's we've Yes, said months as a optimistic about. so far, we've early. launch. But with little earlier, persistence, seen we're We're so the what bit only X or into

is think And really what real we are a we've look, and is focus and you what look we're people And that's the get pipeline you we're always one talk at? looking wanting already. what to experiencing that to perspective we is inbound something And already. From And -- that things in of of at in BD Hey, clearly seeing are the said because we a able cohorts. at patients, as the even at mark going be least to few need you even past to think know, number beginning, there's from that then, be have very looking the start growing the of XX-month to with able XX I months say. get months to the sample trials It's get we're on be it for mark. XX-month optimistic enough have XX the to of got based really on of NASH. a world everything. about leadership to really been patients to we kind at a build you've But the our leader. of to calls about you a to to want clinical measure is I that space in

the perspective, an has NASH I a that reach in think partnership and forth to across certainly a us. From has is going who stage they're so look and to gamut. looking anyone out product we'll interest at

a advantage. We now. leadership position the have We're in

best Rezdiffra. this have product. look good be alone deep deep, et potentially we to we are what experience what Rezdiffra of action therapy in deep, have going with mechanism combination, And a foundational believe would for the But is or next We opportunities is a space. we fantastic cetera. of

we products. thing way of So feel like make add going right us. a for is in would the be so product we're in thoughtful something that sure or to the position pick portfolio, we're what and we do product to the truly very make to And to call good right a the

when a side start be and we'll forward that that. the are then the has intent to. evaluate. moving industry, So especially is, that leading is is well just clear stated we something perfectly be see me NASH actionable, feel what in to period, a But underway, with consider And term see let we our it. we company continue right, we'll how that's to strong we're short, you medium to off when And long

Tina Ventura

time A Great. website about and Thanks, our interest. will webcast your We're this Bill. available on today And thank hours. of all for you in the your conclude going be to X call. replay

us. for you thank joining So

Operator

Ladies in you your participation thank gentlemen, for today's and conference.

You day. may now disconnect. Have wonderful a

Madrigal Pharmaceuticals (MDGL) 31 Oct 242024 Q3 Earnings call transcript