MDGL - Earnings call transcript Q2 2024 | Madrigal Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, and thank you for standing by. Welcome to the Madrigal Pharmaceuticals Second Quarter 2024 Earnings Conference Call. [Operator Instructions]

As a reminder, today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahead.

Tina Ventura

Loyola. you, Thank and Madrigal's everyone, for us joining Good Quarter thank XXXX discuss Second 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 will on section our that have a

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

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

William Sibold

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

a off this First, quarter. where we an are the launch, update strong start Rezdiffra to on

with and Our key metrics consistent to intent awareness are reflecting strength prescribe. also are physician and high market showing research

progress wiring the expect X we what a priority. our be #X we where about our into process. to months XX-month are This system, is Second,

behavior a efficient As launches, first-in-disease we and are processes patient developing in with clinical practice driving physician and prescription other and for change flow.

establish Rezdiffra. Our support peak foundation value of maximize to strong goal sales. And is to to a long-term third, our the strategy

plan to next Rezdiffra untapped the expected to launch opportunity in that the directly addition we announced Europe In EMA we following U.S., in year. decision an today

on X. Slide Let's the launch start with

uptake. and more the areas: payer second providing X quarter sales million our quarter in are Rezdiffra. patients demand, coverage We than metrics exited patient quarter in $XX.X key first on the net discussed including with As generated in numbers, quarter X,XXX second and prescriber we on call,

fill specialty demand, Madrigal we and lot payers. the prescription it the on time driving of takes pharmacies to community, patient a put support, focus a have to with addition In physician

with selection on focused is team prescribers. patient field Our

Our distribution are specialty efficient pharmacies in the efficiently the limited and patient payers on need. support executing exceptions recognize our driving more are unmet processing they network medical team and prescription because

quickly result, process. moving the through a patients As are more reimbursement

We at about the need coverage transplants about was clinical patients is Rezdiffra NASH, or States. commercial understand They of They second expectation those our months. United payers. fill to or our quarter Because NITs, time of standard lives. unmet the XX liver also the care. Last improve days for less also quarter encouraged women XX very in are the discussed have recognize efforts, to made in for not time from to launch at to in progress days tests that fill running significant was previously noninvasive for X which with a we've XX% #X compared the and initial biopsies expectations. We're FX/FX of by faster driver at of the of benefits to

As and of lives, June Rezdiffra biopsies. XX% not than for commercial place covered have requiring in coverage of Rezdiffra of lives more over accepting now XX, with NITs XX%

of commercial XX% covered well to lives of achieving on our year-end. way We by are goal our

biopsies. As far all virtually all commercial in NITs Medicaid July as states. do as XX accept was X, and to with coverage we've government of not coverage payers, seen what place Similar require across

via medications. Currently, consistent For with requirements authorization process accessing Medicare, annual the we are based process Rezdiffra coverage next review on are X our the label. on Medicare track year exception patients medical for beginning new January full of with for prior

launches penetration XX% diagnosed X,XXX medicines. and of quarter, the prescription, a aligned We have with second we targets is made FX/FX of with hepatologists top that blockbuster approximately are level for caring are the Rezdiffra the vast top which targeting, gastroenterologists we majority often are progress our XXX,XXX pleased in seen wrote who with the the of patients. In the

you'd the expect, their their bit given Gastroenterology hepatologists in different can primary think the with and launch, activation board, that we NITs. longer physician quickly take to stage disease As each practices area seen dynamics patients. Across adopting more through expertise early disease a NASH add continue of for due we've a is they need at and and prescribers. to to practice steadily isn't

prescribers. process Our and continue efforts. that do XX-month top conviction new writing of opportunity shift prescribers system targeting wire the on X. We're XX% to be what that Significant the targets substantially initial expect expand about with Slide the stages physicians to to more prescriptions well, we're To more prescribers to are than to successfully in giving accomplish goal. us this we right we remains as frequent early to need a noted of their

and treatments, with first-time work behavior to to lot there's are Just physicians' change patients the steadily do. states pathway build help Rezdiffra disease like in launch prescriptions made and process of are physician a but it's at We've efficiently we working early prescriber to still adding other great we offices. progress, and a

For risks urgent. they physicians, real the of activating to are and risks a educating them write about are The NASH it's on and prescription.

of years. For progression outcomes. NASH patients XX,XXX liver-related highlights baseline, Optum example, to XX% Of progressed cirrhosis approximately without study database cirrhosis within adverse economic an claims to our health decompensated at X of alarming rates

panel using identify Rezdiffra are U.S. disease the physicians In using as we state published and and guidelines. NITs addition to as appropriate well also helping the recommendations expert recently EASL for Rezdiffra patients education,

staff, patients future staff For to to helping evolving volume create process This pathway it's patients require additional and manage can about handle process. and the to the office the prescriptions practices anticipate. navigate we reimbursement a

continuing NASH, and and on testing paying off That's the coverage. system patients. of to health been their to continue we're have care of noninvasive NASH with different treatment benefits journey. the while through risk And support to the the for favorable clinical patients, navigate For Rezdiffra of payers, helping dialogue them on of complexities them costs we educate productive Rezdiffra

that requires a repetition discipline, time. approach absolutely work, patient-by-patient. tailored So doing This the we're practice-by-practice, and payer-by-payer physician-by-physician, and is

a to pull through wired, to accounts smoother it's the blockbuster As the still more create through. prescriptions early building We're easier confident medicine. that in are but and we become foundation the stages, becomes send process needed we're

launch drives optimism our Rezdiffra as X. of noted our Europe, on The to directly Slide in commercialize decision U.S.

We Europe marketing following have been our year. the submission of earlier application strategy evaluating our this

next which expect decision Rezdiffra first in would an make EMA NASH year, midyear the We treatment available Europe.

are attractive Our future decision preserve for commercialize Europe allows the population Europe us of Europe of in maintain Rezdiffra From than Europe. III increase value to marked our prevalence carcinoma several XXXX NASH-related in opportunity by more established patient expected NASH a increase asset, potentially through is in NASH the a the HCC hepatocellular is in foundational clinical to driving for to a create as Rezdiffra XXX%. We've in Phase is XXXX, to strategic significant, cases reasons. and of The MAESTRO-NASH trial. therapy platform flexibility NASH growth. an full

with fibrosis positive guidelines. only through And clinical in We approved We III sites European consistent Phase in yet for formed strong EASL to program being relationships disease-specific clinical that guidelines have first-line as was Rezdiffra moderate our favorably the community NASH results is it positioned has note with The trial. despite NASH agent not advanced the This FX/FX in with Europe. with Europe. in and clinical development a affairs our presence Rezdiffra also medical from practice registrational been the team. therapy on-the-ground trial XXX European NASH

the in in build now are starting Rezdiffra XXXX. infrastructure to to Europe We commercialize

they our because aspect strategy patients with life on treat key use compensated X. an Another are to is a times management risk Rezdiffra cirrhosis of liver-related urgency seen of mortality. cirrhosis There with to XX the cycle higher higher is expanding for as patients Slide even at

Rezdiffra evaluates population events patients has this an to NASH opportunity. this our the trial outcomes in that noninvasively compensated An indication cirrhosis. population. It's measures potential in to patient event-driven trial MAESTRO-NASH Our liver patient progression in decompensation double with

conclude on by me summarizing Let Slide progress our X.

in and us enviable being the first sustainable advantage. market giving strong to of have competitive We NASH, position a

this We for in long-term leadership ourselves now globally opportunity, are in leveraging U.S. and expected launch with the fully our Europe. positioning

It's halt XX% starting to a team front with demonstrated that We stiffness out launch of product of It's years. liver-directed profile. launched us, improve ability to an pill. liver in opportunity expert highly blockbuster well-tolerated effective resourced dozens have once-daily, the X the that's we've in an patients or to match medicines. medicine a And has of the desirable

still of than for growth. in XX% more we're biopsies sales as top FX/FX therapy endorsed making EASL a metrics. Net we launch, have $XX.X not many guidelines progress on all expert the covered, commercial with patients panel Recently line communicated. in with of room recommendations we're on lives drug, targets good X,XXX significant published NASH. in Approximately have prescribed U.S. of virtually Rezdiffra require early million, for and what While XX% first-line more do NITs than accept our

and and educate more clinical pathways work do help care activate change patients. for to to efficient them have practice to to We create physicians

at and patients point in and We adding line are would with tracking launch. in what expect prescribers this right steadily the we

As our are cirrhosis execute Rezdiffra to we trial year. indication with plan opportunity as we expansion to look a as well the forward, on our forward FX/FX outcomes we as look Europe in data we blockbuster on in building patients we NASH, next launch expansion patient medicine expansion untapped to way from and in geographic

accepted proud to supply. is expert reflect I'm my Rezdiffra we've with The We Before filing, Rezdiffra no weeks the and I team. than including and review, company. level, and let turn we case of field label, made very at requirement. priority with team month. importantly ready role best built to built the biopsy launch The approval the was received on months, as We over ship team in progress XX X. We the accomplished quickly of promoting me we was less a briefly commercial the in out no team FDA I've level an call day a on at approval Mardi, this sufficient required. product the within incredible. a been we've leadership a full received support very what AdCom pretty

plans, seen building is a Rezdiffra all have We've favorable favorable been coverage We physician published. and virtually biopsy. relationships. requiring guidelines strong not Payer

that and We're do. executing we said are to progress. there's more early still on we we would. work making So everything It's

sales. look the a we the forward, are our to for build of strong peak As plans to X/X way the about wire system through our support to aspiration foundation we

to We right more have Rezdiffra. in place even that, and do in the potential significant of strategy confident the we're

So Mardi? with that,

Mardi Dier

issued second contains so results, net earlier release U.S. Bill. for quarter The will as highlights of today Yes. the demand X we million, for our of you, inventory. $XX.X few on I Slide financial full provide product noted and were sales press a XXXX. comprised quarter Thank the

it was demand. mostly For the quarter,

inventory typical as quarter the anticipated medicine. Gross our expect for is was weeks to than to run for net assistance expectations We co-pay for Rezdiffra quarter. as to a lower for our specialty favorable this particular between X X to was

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

anticipate to rest as is quarter expected. $XX.X relatively the continue R&D million the expenses for to year-over-year of XXXX. year. SG&A steady million level of This comparted a were increase We the second $XXX.X for of

quarter commercial approval the As we scale-up discussed last Rezdiffra. due the operations of following our March to of

With to the related -- of build in announcement a and to to XXXX Europe, Rezdiffra launch we intent so in our our in expect XXXX. infrastructure more modest increase

option March public well exercises. turn we of to Tina. our shoot billion, of and support due balance last slightly multiyear Moving at what offering closing cash over back of cash, securities reported from than a quarter higher cash as $X.X stood With is of launch our successful to to from position, are to the strong XX, now proceeds sheet. our XXXX, Rezdiffra. I'll call June the the and equivalents, The resourced our balance we cash marketable restricted which green

Tina Ventura

Thanks, Mardi.

if We to questions will for to today. We the we're the now possible open would you as open through questions. get as as call. Loyola, to could like questions one call trying limit many

Operator

[Operator Instructions]

question comes Partners. with Smith Thomas from first Our Leerink

Thomas Smith

appreciate Congrats -- if on quarter. I all prepared wondering remarks. color could launch nice you the the was the just I in

due is demands bit of and that more could little and was versus how much $XX.X underlying of and related million stocking. revenues, Just elaborate within of just wondering quantify inventory how maybe a to you much built net prescriptions to being initial that patient that if

William Sibold

Great, Tom. Thanks. Mardi?

Mardi Dier

characterize quarter. for mostly the inventory Yes. in Great. Tom, and it's this to versus great the $XX.X sales that we're question. going net demand demand is million How

result So nice how performed quarter. and our the for we're pleased a really team had cross-functionally

forward moving However, X to typical want just reiterate is inventory, most on seen the we've that specialty days we medicines. with for weeks, to X hand as

the what We we of want system. the that also to at through our reiterate We're of beginning think to launch, need we're stages wire way we about the right? X/X

we into the ourselves that just look we both Bill that that and quarter. of And just steadily not as point to make one progress very nice quarter made everyone clearly launch So we want to next our be in we other I'll patients get careful forward, add ahead move forward had we'll looking prescribers and forward. as

Operator

Tan comes Goldman with Sachs. Our next from Andrea question

Andrea Tan

just July. here. of if Maybe over as cadence of I launch I And given have exiting focus just quarter. the the update X,XXX to the on provide drug? you're what are proportion the able numbers on paid you end patient an know then on wondering

William Sibold

about Thanks we're progression. Look, for going the Andrea. month-to-month question, to talk not

think we to it adding steadily is characterized the we've And through was way patients certainly July. what we're I that prescribers. that and continue see

there very to free quarter. drug, relates was little this As it

we more some the that there'll that have As the we patients more as look free utilizing towards expect drug services we we provide. various though, future, be

Operator

comes Akash next question Jefferies. with Our Tewari from

Amy Li

This for is Amy Akash. on

by an on is once I revenues a properly then a base these covered of trajectory be year. require than you implied that be in they in consensus are there Or will just Of Medicare? can year, biopsy, you like next feel next plans are if one on launch there launch more give us case the is Rezdiffra the significant in inflection sneak could your that So access line? sense will what mostly Do gradual? less more. acceleration a X% plans lives, the is And

William Sibold

we but come commercial Sorry, in will online guess talking one, was Medicare, January. with not the have are lives, Medicare, what I last we about covered

just be than XX% lives. the covered So clear, greater commercial to is

-- what the were So around that's those stats it.

away wire that we've including product that, that community what it system never the beginning uptake, you're about first-in-disease through about Regarding use really we've is a anything went that time to think the launching from now. is for in an said clear a We're X/X off-label or takes to in And I XX-month look the really been X/X anything process. a of we and when the that that's they about had to that capacity. about way have

as you into Now QX. remember, always then in the have QX and of of next QX moved there's we through get year, year -- reset we this

XX So place. we'll months we're of that -- that's we why of our feel And in the QX talked time, we through end the have about by 'XX. reimbursement

through. with and trained prescription We much physician more that and practices been have will just a have comfortable writing pulling it

that's expect able see So and to more to the be that move through whole when patients them from practices, will both just through we identification an ease of process. ushering

Operator

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

Andy Chen

on Congratulations quarter. the

a these the So me hypothetical require payers bat? right experience. please what know XXX,XXX a basically if right you the thinking off of of fraction remind percent about that's now, the bypass your not can are among patients, research GLP-X for step. the market based me very where GLP-X I'm requirement patients them case I would scenario entertain What moment. on but

William Sibold

say you do have Or physicians GLP-Xs? Andy? experience, Patient experience with

Andy Chen

yes. patient in they the experience pay it a have used past, like Oh,

William Sibold

hearing seeing there's from Yes. at that some exposed we're practices patients have GLP-X. that -- more with been Look, point we're

on of that As trial, our in you know, we even XX% GLP-X. clinical patients had were

that I'll Now on the you. was remind diabetes dose.

could as However, are we're are on. you And Was they is, being X hearing any ago, Question the that they certainly exposed those it XX GLP-Xs. with or X when be ago more to to answers. rates, month months months it still of were discontinuation ago, patients always exposed? know, yes

but right early our get there to now. So a it's concomitantly some it's what and of still some that that are we're on data is information seeing from own pretty patients are that GLP-X, tough

haven't seen anyone GLP-X. payers, a step-through Regarding requiring we

Operator

with Merle next question comes UBS. Eliana Our from

Eliana Merle

progress. the Congrats on

uptick You segment. versus from color us versus or if were start seeing mentioned with seeing in now give gastroenterologists. just with uptake you're that Can seeing the that hepatologists a an little you launch? gastroenterology bit And -- the faster in prescribing uptick of trends more at you're the you on gastros the latest the

William Sibold

Yes, question. Eli, thanks for the

sense that to something familiar very a That's get bit So are treating They -- makes hepatologists know been I faster disease. they with look, have going to They're familiar liver. start, the that well. it off very the mean, right? little

get did hepatologists so see And started we the quicker. little a

of there's than as well. practice dynamics more gastroenterologist, through And them the their they're a Now hepatologists. lot working

high on know, there's you in As a focus scoping pretty gastroenterology.

just in how practice they through, do a lot patient a how actually room start there's at matter So is and them. a they process room spending stages but they oftentimes for so, doing we're or what working make doing of in their it's a will how to do they that. patient process and of using have practical APPs that are different interest make time practice now And you're you a to great with that's running

Now are talked that the because our not many writing. country. that there's hepatologists just and about a there's target lot XX% the of of list We target majority is list gastroenterologists gastroenterologists of that in

key that the expect be And adding where patients from we and sit. a are we but progress making said many, So adding just bit bulk to the gastroenterologists hepatology prescriber expected, as going of patients. prescribers this so gastroenterology that's because beginning, and and new as ahead, the there's in a steadily steadily we're we little

Operator

Piper comes Sandler. question Rahimi next Our Yasmeen from from

Yasmeen Rahimi

Europe is Team, you maybe and I great as XXXX as really still guess that on a to of to the cirrhotic commented could thinking well force? could you now a commercial on the focus them and entertaining do that end year you Or on allow sales U.S. this are and between build partnership you commercialize a Europe now in plants you're congrats, really and your into own into think potentially all about patients. work. your quarter for expansion solid about into Could

involved sort be thinking that about you Europe. love about because caveats should maybe for we would think to its just own I in of So how

Do you committed? want are like love to What fully would your are thoughts are there? being So partner? you out

William Sibold

Yes. Thanks for much very the question.

fully me commercialized first all, I've clarification. Europe. multiple to committed the -- provide products in commercializing of our own We Let Europe. We're on in

has In fact, that globally. product been commercialized every

We that have that a well. team as has done

So to extremely do we so. positioned we're well feel like

doing ingredients the so do is execute thing in what's what we've we're them the that whole doing But in Now to know to and team be put that's with they here they could that team do. right same What did place we that? to the leadership Europe. what the is going built

of the and excitement get I launch, very targeted lot so real I we've in in In we well there organized focused, approved, the will several We exactly greater a it's [ learned, of likely action, things there EASL of point the year heard being really there wasn't before but were physicians steps. one very look for that Rezdiffra off of things approval year product though the I We would They is, in a going even at ] or a Europe coming approval. people a EASL at lead believe not of guidelines the out were meant waiting the Europe that prognosticator they had was that in would because Europe. And a Europe had say, post in There's there. learned And I Europe And many is will put got certainty the take weren't certainly of until U.S., despite at approval is approval approval a taking And in year said failures saw the they action U.S. question, until we them well. the as EASL, lot the drug. that And in that been way look if didn't position that ago, well good for take ago, the and be if I for Rezdiffra approved. advance being Germany. we've say to leadership back they approved. U.S. In there because that they was starting our when experience it. this here versus before, and Europe,

we're we've the are that it. excited sites very think Europe that we is that throughout on you Rezdiffra well the exactly as there be above give we had we going So with you approach [indiscernible] to that going as be to a we'll experienced able updates But launch. Europe. XXX the about as way tell bit quite more how And in disciplined we progress it year little trial to is

Operator

Liisa Our from next with comes question Bayko ISI. Evercore

Liisa Bayko

us give to I want of quarter. end it little then on start also a wonder be gross And get you to of at the I to? said patient more was a a if and where color net. you a view choppy, could the sense just on little it what you would ultimately maybe forms know

William Sibold

for Liisa, much question. thank you very the

me start start forms. Let start update forms. with giving any just patient the on not patient We're

that are We And end drug are that just from the there perspective, the have said, you. patients. on were I additions throughout seeing Mardi, to to a the we're That Maybe of net patients as say, quarter providing quarter. I'll at steady prescribers quarter. clearly, and the the to since though, gross

Mardi Dier

the Liisa, Yes, question. absolutely. Thanks, for

but So favorable be our for it's of realm the would what to first our clear expectations, about gross within second We be specialty versus a product. of typical quarter want or that. all net launch quarter was

our the assistance factor expect get bit. patients as to can use help Sort we is we've this sure biggest get set that to and that But up grow efficiently of program now less We of quarter. drug saw as right co-pay on forward, the our co-pay assistance for going us that program a little we make swing possible.

gross But IRA, have choppy into could issues with to net, of first et of that other you essence sort for get net was cetera. and to that the of then, course, So the this main you quarter. and was driver as be gross quarter,

Operator

TD with Cowen. Our next from comes Baral question Ritu

Ritu Baral

ask prior coverage. that to you're plans the the established have more I seeing a ops that bit for about wanted little

diagnosis? assist is the that prior of your in MRI-PDFF seeing imaging that -- are that imaging and consistent diagnostic indicates Our requirements with talk required. access finalized authorization plans. about requirements, a diagnostic maybe work Can MRE is and guys doing you to there's you to own access are imaging for survey work what technologies you And and lot those KOL guys

William Sibold

Well, Ritu. much the thank you very question, for

access of the We are to being not any problematic. seeing NITs as

with what FIB-X imaging MRE, seeing from include perspective. well and a have FibroScan, we test In MRI-PDFF the we're as we're as them obviously really imaging yes, but blood for also Most then blood requirements. and the fact, of tests ELF happy

But it been vary. hasn't So does say. there I been that's anything would concerning,

And as we access that have good map various to physicians access. technologies, the have out these they very

for Now No. relates going I the is it Does thinking alignment everyone to isn't a the X-year to process perfect? combos to be as people out. But use. here. about NITs, community are we're technologies physician And sort access as beginning that at new very well. NITs have There themselves complete it's everything? it which in There's to I said, to as think about

-- take going is there information best be and -- the are sequencing but what that be a physicians. I well, years may it's think just to for think few be before is are the better never say combinations I So there's various there alignment, to going to real going that to

So we think we're in a good place. really

stage be case. not had recall, somebody now to this and just wait. where, practices less you they out than wiring talked back to big the As required there going for that and going the concern our system, and X%. just watch is And biopsy challenge to has was We about been the historically, is the

to memory thing pathway, they rather to than to used of of us kind that, It's that more Now a time when start treat change thinking which implementation what find becomes the leads as curiosity somebody of trying and deciding takes talk patient. the about more another they're one do a so the stage for high-priority they it easier staging. -- And it, talk about it's it to to get actually you is behavior to of getting muscle steady that the we that's where practices the state. here to and is are that Rezdiffra. going do And a or memory with thing prescription the have to Rezdiffra a it

Operator

from Lebowitz comes next question Our with Citi. David

David Lebowitz

the between You XX eventually the was XX we is of this and XX it's to to coming days. exceeding XX in had XX indicated days, days. actually faster time in days fill to or original point at than that Are starting expectations days potentially assume dropping already reached XX

William Sibold

maybe launch, that the And it testament patient that thank the And a actually David, you the quicker. job practices letting we it were the with as great policy them one just in only The was think that that's for FX/FX trying first, place, a help with I little partnership the to directions really been moved until if right even to And a payers too, access was is a to is beginning, very of conscious field chose of we've on temporary their practices know we're we a that we the out clear doing from question. patients bit the in not being patients, effort. so that reason and team this context the experience in was selection. gaining to a expand starting won real data. saying have side either is is to been

payers it's unmet the they also either It's drug and see I really that needs when They to get want don't this. patient to to good. just deny know what crosses acknowledgment happens the not cirrhosis. that a an need the the line a think patient

and make had that if sure right to make that It and of they back also forth. how only there I practices wanting acceleration, patient sure has to to get in many fight have resources to the They was that's why think you so will. didn't we explains want the time. So been deliberate having kind that stuck

as the patients chose right So well. they

through the probably can we've able putting fast. Now is XX to All quite may volume start and be directionally so this in bit, as not the move days time closer we a more prescription little scale begin quality XX that we're drift as comes to XX to back you that days, up you days... in, of said the than to

Operator

comes Wainwright. Our question from with Arce H.C. next Ed

Antonio Arce

quarter. this on Congrats

the quarters, few million, just would about what Just of you And you to the of you're payers COGS COGS And expect commercially, biopsy off are you on wanted $X.X those can would rate to to pressure normalize? a the could prior think discuss initially, there? and When inventory. if first change? I that think identify the ask for also you working which over that for exist time one require might

William Sibold

in Ed, right more very specific we're the and list the to a going payers Gee, in pretty thank Look, a to any required that dynamic work of age to a advocacy. the staging. now. don't I lot from are of of a It's to necessary set prescribers think do. there not complications. beginning appropriate to and have biopsy, especially I front of which are to that day In phase of that for give own you that We and somebody plans, not in the me and and when patients subject some the has just still cases have from allow a NITs we're good biopsy hear much. still diagnosis payers, its have where

said, we're over biopsies. be outliers that discussions place. remember, outliers said out there And those hopeful as we always plans will are take some and requiring expect will just would as we come that that are we But there So those around. there'd time that

patients well it, noninvasive engagement to option payers working and at keep we'll patient have tests. to our sure what is all that have want will We to any to and are treated make subject the be don't it. drive an So that with

that question, the On Mardi? COGS to over I'll turn

Mardi Dier

Ed. Yes. the for question, Thanks

-- in COGS You years burning we right, have we X.X to think will for inventory quite thing X for are course. [indiscernible] what currently. off flows note low normalize is because have which don't COGS small on a And we set up about another the depending to years single-digit point, through would COGS. royalty of line, are Roche, I that also One we really top from this on

So remind is that you, component. molecule But a we're a medicines. I'll small

So going low. Rezdiffra be is for quite COGS to

Operator

Jay question next Olson Oppenheimer. with Our comes from

Jay Olson

other and progress. FX patients you of the timing approximate has Bill of in with benefit not on the you on strategy symptomatic Of important versus Congrats compared FX patients DUPIXENT use your communicating patients, launch FXs. launch the leveraging be comment of direct-to-patient how may is with since X,XXX the to then are symptomatic And can any strategy seeing experience, you his proportions MASH, more on and diseases. and where directly comment can off-label

William Sibold

Jay, the thanks question. for

On FX, the pretty and even. split it's of FX

start put ask would prioritize control can't were patient office your first. I say, probably with, coming you the they physicians to we think want who's to on rather reality that who is the if and day. they into But FX you an

what a make how what show, what's their the based they is that NIT do patient decision -- cetera. So et feel -- upon

two. we balance actually So the see between a

real who have not don't to I clear that. label, off-label, don't is We've just patient that is and the would a in understand that it cirrhosis. into And appropriate or Rezdiffra insight been physicians. it's and with Who sure ask data obviously, very our talk for they not we have Regarding for we any so with about make support. appropriate never

a haven't broadly. it is heard So we there as way Certainly, of being I knowing. have really -- we some -- no

why, patients. I think that's forth. And we little really people fill so the focused right to are better I bit a saw think time and again, on

the education. or patient patient direct the Regarding

is recognized a a said, patients transplants disease but started. So about educating in is Those but a think disease just reach DTC very that really is well #X women to It's for our really cause I it that statistic. have the United already, perspective, that I by that when many, disease consequences, as liver And staggering direct for efforts through we've get has important more not understood, important. been are a serious not States, you cetera. et out well of

We have the on that. me activating believe we are patients let diagnosed and crystal be and by believe clear already to that be that educated patients

towards to educated to directed get be are are that Our going better activated and for patients the to XXX,XXX able to NASH be field important them to having the already diagnosed be treat and the to -- able be I'd say, efforts will Rezdiffra. access for patients

we efforts disease to source starting expect certainly about more and the those So be helpful and they're are those future. for but about more And learn really of near to the learn in patients provide product. a kind ongoing, the

Operator

Our question Cantor. Prakhar next from comes with Agrawal

Prakhar Agrawal

will are Rezdiffra response months physicians for XX patients to on stable quarter improvement what who some hearing have just patients require on what on you and show will will Congrats one, the Rezdiffra Specifically and non-invasives? or track reauthorization? at only payers and reauthorized for beyond on I the launch. be

William Sibold

there thank reauthorization the at are around hearing Prakhar, right? much Yes, XX for that you question. period a very typical, of we kind that's are And months.

time For that is the specialty stabilization actually whatever from -- so, well. said, patient months, first something now products, today But going it's that's period that aren't about to improvement. months think are away you to as talk them. and have And a any We that there's reauthorization range. months X the or as We're still have it of reasonable. at or if the that that payers they through XX they're to you continue point. It to where either that varies. in policies are we X between But

talked as as a We and FDA fibrosis weeks out seeing, at in talked because expert look gastroenterology such looking and a recently and overcome. XX-month is have patient with you press a the efficacy They to at their stages. effect and that thought because efficacy XX months that's the months at this for patient, is several taking about the at remember, X they clinical after measure look significant we we're with seen about hurdle What time that then kind with right to really that have in fibrosis think to said release hepatology. that was right. recommendations They an well to the think early instance, did we of XX in what's came happening identifying a

right well. put that expert the say we been have with and what now as that the comfortable forth we're policies comfortable very So with recommendations we're think

Operator

Jon Citizens Our Wolleben comes next question from JMP. with

Jonathan Wolleben

the of what thinking Just now peak times the kind is you're peak couple when Bill, in defer especially pack mentioned internally full a one. us you're sales how prepared Europe? economics for opportunity you of Wondering remarks. about your thinking in

William Sibold

as out tell not to that. you going market right U.S. alone, I'm other is great calling think And me question. about Thanks a at there's than, it's I just look, on we look think, becomes Jon, a now specialty-like talking to category. I start XXX,XXX overall, a the ends and where I This about billions at penetrating patients. category. has, way to product profile. the specialty we're for dynamics durable peak that and said, Any you what look think we up a mean, this it's you NASH

you anyone at you, have presented And When none think you any of information a them take. got to I'll at lot going they and to of that's good of have especially lot still patients, at easier them you make these ask to they we add as that tell other on injectable is Pill regimen for patients, time. feel either, a to pills. we EASL, some another that us and great as stay a is and even are don't look something then don't stuff you're long my

still haven't up. the we is Now opens that we're -- clearly, from perspective. on total And an from EU an working what opportunity perspective, then FX things

So I a we look I we're not long to but any we generated position profile, position we numbers category long the to anyone think will that ahead going us. We of continuing in without this the are we think and want. you the that to and the be because who's of lead comprehensive giving you of look, know time even we're big set we've are the -- now. way that's product talking for at be way is lot next But a that specialty lead a generate, think in only that it, you data a

Tina Ventura

webcast thank joining Thank for available for concludes your us. much so be our And website and our call. today This on will this of in A X you about Jon. all your time Thanks, interest. now replay you hours.

Operator

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

day. Have wonderful disconnect. a now may You

Madrigal Pharmaceuticals (MDGL) 7 Aug 242024 Q2 Earnings call transcript