UTHR - Earnings call transcript Q4 2024 | United Therapeutics Corporation

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Operator

Good morning, and welcome to the United Therapeutics Corporation Fourth Quarter 2024 Corporate Update. My name is Cindy, and I will be your conference operator today. [Operator Instructions] Please note this call is being recorded.

I will now like to turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics. ahead. go Please

Dewey Steadman

our and may you Cindy, Corporate It's pleasure materially. risks statements my Webcast. events. regarding Thank statements actual These the good results United welcome involve representing forward-looking include to today uncertainties XXXX or Therapeutics to beliefs Remarks future that you, and will morning. expectations cause Fourth Update differ Quarter to

to information update Forms of on filings, other forward-looking progress latest including XX-K assume our and to no contain the We SEC with developments today's obligation risks these our Also additional these and statements. or discuss remarks uncertainties. Our XX-Q, respect products. clinical may trials results and

for intended These investigational suggest are educate to the intended safe medical that our solely any and available products basis prescribing effective Full investors products or decision-making to unapproved remarks are for any on are or to are for not information and uses. the serve as website.

today's our Financial Martine President and on are Leigh of and Product our Officer; Edgemond, James Development President me Dr. Operating Vice Operations. and President Poisson, Benkowitz, and Chairperson Chief Treasurer; Executive our Rothblatt, and Executive Pat Peterson, Dr. Michael Chief Executive call of Accompanying Vice Officer Chief Officer; our Technical Xenotransplantation; our

finally, Benkowitz Healthcare along And in And Medical the UBS Healthcare TD XX. XXth Then on X. at at scientific, Annual in Cowen Golden, Transplantation London at March silvers Note medical Conference Conference Boston, James will in and teams the commercial the at Edgemond, on I on X our participate Gil March and March Miami Officer, X. in present on for John be Harry Michael on At my colleague in XX and International be our will chat Healthcare Symposia Conference that meetings April in I European will Harry and Heart Memorial a London. will one-on-one fireside with X March to Boston the Society Chief Lung Annual and affairs Leerink XXth Vein the Global and XX. Conference

turn I'll our overview now business development to for an And Martine activities. webcast Martine? pipeline of the and over

Martine Rothblatt

Thank you, morning, and good everyone. Dewey,

and We shareholders, leisure. your XXXX. I to Congratulations another not for to the it at you for review those reference, year speak to Therapeutics going available have in encourage supporting I'm to the and X,XXX for United than directly our you, slides to record revenue slides. Unitherians more

patients a record-setting drive In This fact, relentless XXXX in of was and their improve by underserved solutions diseases, broad amazing a our year to third with deliver revenue. row of help was lives. rare driven our performance them to array

have starting events, performance, cascade Beyond trial. our for with of now our commercial clearance UKidney stellar clinical our clinical the we X-year and IND recent begun regulatory

their xeno the chance supporting disease end is for first an This little kidney have human of a trial who renal of cannot a clinical end-stage the declines. before and FDA-cleared to dialysis could trial transplant obtaining health opportunity organ thousands provide an patients registration of for with put one of qualify who hundreds to

month, first idiopathic year. the expect pulmonary study X we this We the transplant TETON in fibrosis. of of middle treprostinil enrollment inhaled Last the in completed

multifactorial INCREASE with has treat this is antifibrotic encouraged data year half a to antiproliferative study. complementary half in the and is drugs of second X extremely been believe line be of anti-inflammatory in top IPF the hoc demonstrated from action IPF first we just and post in existing face many to of than approved pulmonary line of hard top are TETON we XXXX. the be dilator patients analysis development, the mechanisms saw its even could scientifically but far hypertension to success expect late-stage in in the more We TETON of IPF the with to study of IPF data we and agents potential which a X Treprostinil,

of is on be to arterial excited potentially market. all. Our to bring once-a-day change oral use first leading of the need possible prostacyclin goal the existing additional as upfront positioning for ralinepag the of to potential to to prostacyclins could not treatment the something the the prostacyclins of patients. PAH. this agonist quickly And true innovation that's to therapies in We're successful, paradigm, in ralinepag in If pulmonary patients for hypertension market fundamentally tremendously PAH potential as

more U.S. to example conclude twice-daily an $X.X year, for a all As and ADVANCE the product ralinepag enrollment annual [indiscernible] study oral billion in is a logs than daily unlike expect XXXX. twice a the with this this in line dose allowing later prostacyclins top sales, outcome potential of we in selexipag, ceiling for ralinepag, for data

the revolutionary allocation on capital past remain development PAH record one products IPF Any and with better of patients inhaled all treprostinil philosophy. first-line financial use Literature through on or respectively, shareholders for progressed patients multibillion-dollar treated we PDE-X each IPF and generally portfolios. PAH to fundamentally and We've use how traditional revenue quarters, a represents across suggested of trial opportunity several In our barrel X us. could these leads has revenue philosophy complement touched capital therapy. focused our long change and earlier results. ERA and of potential posted registration allocation we that ralinepag prostacyclin are the for or launched algorithm commercial performance, that would have orals xeno of and needs areas both X or kidney first ESRD disciplined for once-a-day you, the studies our a the organ

DPI CapEx to and new support support real We've commercial needs. additional invested estate manufacturing acquired in facility to Tyvaso our future manufacturing

accelerated complete Miromatrix we the our DPF Virginia and corporate X world's IVIVA We also all you, this, still alternative to we share received. and commissioned program enhance others. $X well And first technologies billion repurchase universally expertise, to scale On business. we've that in development, was an with development and licensed shareholders, in acquired to treprostinil to new plan through support organ returned our our clinical

on of performance and United a in core progress allocation. and development capital better position continue management an capital in areas and at XXXX. we're to we've revolutionary innovative philosophy Record financial allocation We evaluate our been to never ahead programs, our with Therapeutics, disciplined basis. X all forge ongoing excited will

with turn our Mike? And over call our quarter. Mike to of an that, the overview who will I'll performance now give for the Benkowitz, commercial President,

Michael Benkowitz

contributors, good we Unituxin, Thank our leading all pleased to and and Martin U.S. Remodulin, Orenitram everyone. revenue percent as year driven double-digit year revenue XX% report Today, for over almost full by another you, are Martin, revenue to of growth record-breaking morning, growth mentioned, XXXX. Tyvaso, major

record we total referrals the from with growth quarter, XX% and and record XXXX For saw near of shipments total quarter along fourth treprostinil revenue starts. the patient saw

The revenues contracting Our our quarter in efforts a setting. fourth revenue quarter the was discuss will sequentially, slightly moment. total which record gross for I decline net net fourth our due revenue while was for is in Tyvaso, in modest down recent to part

normally increase recent Total XQ and revenue gross was to This for in patient Tyvaso commercial with sequential by strong quarter, for quarter. few $XXX contracting previous the a what XX% was the was shipments in quarter deduction execution The continued highlighting from with quarters. million, driven record referrals starts seasonally par is net challenging a the over associated the near record we've on and revenue year. Tyvaso previous fourth efforts our larger been decline XQ, to primarily largely that last by driven a

at position and Tyvaso with parity Our to potential conducted and and Tyvaso investment DPI products. help in these nebulized contracting future competitor efforts was current

grow. became we over pulled investments and contracts As these rebates the can we this and these effective additional in of continue creating we fourth have point, this have fourth the noted, At quarters largely third quarter. believe Tyvaso which been impact base a from and new new previously through, primarily saw XXXX, to

Orenitram. the to XXXX saw Orenitram, normally quarter growth of we high-risk for for discussions needing line PAA quarter XX% in influencing are Orenitram patient revenue indicating third reported study treatment, Moving from fourth what seasonally transitions, of specialty again, in the and record million, a that fourth about is scientific largely weak efforts to $XXX with along our In Orenitram educational with coming of now patients use. starts to expedite we around additional us intermediate quarter with ordering. XX% shipments the Close XXXX, are pharmacy quarter, Remodulin use the to fourth

We shipments. fourth record XX% Moving setting to up $XXX the Remodulin. U.S. reported another patient XX%, revenue quarter revenue period. million worldwide of for year prior grew from

Remunity immunity, trends see with to Pro our the input subcutaneous for and use. features Deca the and next-generation strong a broader to guidance, with January, Remunity automatic on simplified unique with PAH priming. simplify patient build is partner to Pro pump. touchscreen new further platform our continue streamlined Remunity start pump designed incorporates for Remodulin. Pro optimized pump PAH. step-by-step Remunity designed patients received and referral technology, and Remunity Pro clearance FDA We with practitioners and for through driven In alerts, accessibility from daily remote offers patients pump filling intuitive technology Compared

this launch to expect We year. Remunity Pro later

prior record underlying the with fourth U.S. we of commercial of are we Unituxin contracting achieved demonstrates our team's the volume and business from we our continue up, And To shareholders. our This dynamics price that strong. both believe recent market remain this patients well revenue year Unituxin presence to was medicines wrap value as efforts, our million, in growth Finally, our for positioned the the quarter to the of revenue providing quarter, to strong $XX extremely and product's proud important investment quarter. delivering while by for up very our commercial of accomplishments increases. driven XX% $XX the million effectiveness strategies. are

to you Martine, I'll run back things Q&A. turn the to

Martine Rothblatt

very open the lines Thank Operator, to any you questions. much, Mike. please

Operator

Our Jefferies. Roger Instructions] comes Song first from of [Operator question

Jiale Song

then how commercial you about And Great. growth with questions. sales have so quarters? don't a for the And seasonality the you Congrats should we think upcoming on some the then mentioned I franchise we understand XXXX start year X this Maybe guidance, pipeline for top given line And also for trajectory you then in [indiscernible] year. the provide quarter. the

Martine Rothblatt

Thank Roger, for the question and to you, that Mike. bounce kudos, I'll

Michael Benkowitz

Sure.

products. as XXXX our foundational -- I business, as is call existing of relates our what portfolio commercial kind you about think So we of to and it think our which beyond

couple meaningful then we last expected expect last we with that in approval I -- double of the way. ralinepag mid-decade the continue for quarters years, think few growth we've Tyvaso, should saying a to and that is into -- inflect digits really, IPF out to can been obviously, grow for and reduction

So of . went employed over couple over with the even really, effect quarters, of efforts, last or to quarters. couple that the the contracting we last

of that for change no in see business in next really X perspective We the terms the years. base

deliver said, double-digit performance. I So we revenue like that continue execute can to commercially. And growth

Martine Rothblatt

Michael. answer, Perfect Thank you.

Operator

next of The comes Fye from JPMorgan. Jessica question

Jessica Fye

Great.

there's the in the the about larger support expected So that investment transplant? clinical just you'll in what first for be talk what proceeding waiting first in scale about facilities? UKidney would you transplant next points for the I to additional think with proof a the trial and midyear, on to then can period program between And second. talk at DPF looking

Martine Rothblatt

to Jessica. morning, voice EVP, this flip hear and our Dr. Peterson, to xeno. your Nice over I'll that question

Leigh Peterson

Yes.

far have you where open throughout safety So data, involving. it our and then review as patient the which then, actually participants. is as well have going committee including formal committee rate rate, period of infections. endpoints safety but that course, steering we're data. to to what well is we'll point success, at all remainder Well, includes data into single And and a zeonatic label, monitoring At which we ratio safety, phase have as infections, or demonstration be this of will mentioned, we our of kidney a list survival function a independent parameters as survival again going the looking it's patients. we and have cohort plan of the DSMB, patient of the as of data the and study a of transmission as as XX with because well potential of of the survival review graft of we're of forward a starts determine risk-benefit the we and several a X up X-month be graft as involving study, -- as And XX-week our of

Martine Rothblatt

as in speculate additional that but great the to premature answer. be And spending consider DPS terms Leigh, just facilities, it on proceeds. of just it's on will something that, that's trial we'll a

Operator

The next from comes UBS. of question Ash Verma

Ashwani Verma

late you've how understand understand you the line that This your And to wanted combo from Windever your faster talked study Hyperion but innerwear grow I past, the view still I earlier side? finished earlier insulating line therapy products in the Tyvaso than was than that business. expected, the impact on with PAS winner about expected. and used some moves of that position, can and kind your of to now PAH

Martine Rothblatt

this Thank answer you, I best would that Ash, for morning. be think question. dialing in the person that Mike, to

Michael Benkowitz

Sure.

obviously, I over So in I study, Hyperion how of the next we'll think couple out terms see mean, that of plays quarters. the

all that I the grow in along, to ] in patients. continue treatment said not do addition prostacyclin. expect it's PAH we -- I [ to the still we're across It digits armamentarium. As to the double first answer our a doesn't is question, we definitely is said replace Which as Wind not great cure. River going not think -- to It's a for franchise.

in with that's being is I prostacyclin. what think now seen we've eased until combination

the start be continue progressive I move long use for start prostacyclin because case Wind whether eventually, River they're disease over before whatever immaterial I get and to of a a the prostacyclin. to think to think to prostacyclin term, [ to going or wherever PAH reason continues patients ] physicians after that if be that's will ahead on

kind we the impact our immaterial. business think long over of the as is really be going So we term, to about think be

Martine Rothblatt

Michael. Excellent,

Operator

Joseph from comes question next The Cowen. of Thome TD

Joseph Thome

you like we've the and kind press yesterday, as on be [ related to Congrats patients this disease the releases hospitals watch as themselves home severity context it able baseline Maybe ]. able clinical maybe guess, been formal do happens. Danone kind can that, ] xeno progress study on from transplant. these well? new disease to formal the to to as of into [ Can another it first relates then we And in the to Mizone I either continue patients case that to you obviously progress. the baseline that the of or of the Is enrolled sources. return expect it was through early in this the seems follow be severity will of study going as as put the

Martine Rothblatt

Thank you, Joe.

I think on very a Dr. that Peterson could you answer good question. give

Leigh Peterson

Yes.

news Ms. our your how will to think second we about was question the and with study regard with been I patients clinical So Leni. what's follow shown

be will not We doing that.

seen the this for be that data study -- clinical more don't not have are -- where what as names to Our -- there's traditional case. a studies, privacy EIND will same clinical that. patient be will follow we you've you the it with It like

comorbidities, of far eligible And kidney As not our as will or patients. it are specifically very very, heart like patients. the list. -- transplant but as One severe cardiovascular X eligibility, the several don't not several asking other. who the you're current eligibility sick like have patients, as includes first comorbidities won't they X wait for populations they're patients -- about have probably well patients

do Ms. population, the So list reasons. eligible which have but for that an second be combination also probably into, an factors a blood which is or of to to expected sensitization won't they transplant they type O X allo due years. for get not we these or things such would as then least Loney transplant are a to at And other medical allo -- again, HLA to not are get factors, fall expected

a have population an -- And the expected so not transplant. they're this a on allo where, good list, to they're but to receiving of second really again, is chance

patients We're you you've really a bit what to Ms. really, understand what we is is like been little comparison is very similar of where follow is. you to again, And -- So to where similar and status, I which hope category her. able -- probably help that gives her to understand she really very indication, Loney, an happy patients really of in second where the great. to

Martine Rothblatt

Thank you, Dr. answer. Peterson. Superb XXX-degree

Operator

comes Ruiz of question from next Roanna Leerink. The

Roanna Clarissa Ruiz

to from specifically. a volumes XQ redesign if the trends Could in So growth that? seasonality curious commercial going any Just XQ? ILD side on PH-ILD question color Part plus about in possibly Tyvaso some increase on outweigh there's under prescribing D

Martine Rothblatt

you question, interesting that? Michael, Roanna. can Very answer

Michael Benkowitz

Sure.

our terms coming as dry seeing force that the sorry, the try the PH-ILD the XXXX PH-ILD we -- part patients. in in physicians you and drive sales I'm really in expanded prescribing think into growth, question or of recall, growth I treaters. are the prescribing of first ILD Those -- PH-ILD around to

until prior it that physicians So was think of launch prescribing or up Tyvaso. I we were is that, and at to to prescribing and were seeing were majority clinics referred vast pulmonary that, at hypertension least what PH-ILD patients those the being

-- so population, impact but be market. the a to able going model an going penetrate and were wasn't you forward of the And that of as have to sustainable kind we think if really to really patient

that really So disease continue patients. educate behind to to only of on the treaters to how idea to was really how the but use start the the start not ILD Tyvaso was these sort the expansion to to manage

will off So far I has that, in say spades. that paid so

If at majority growth you of growth The treating community. the of ILD is our the XXXX. that course over in look

So X-plus we're to then that get the and X, X, XX to we the to get of prescribers X, to in then often starting -- to about and are on up X, I depth. patients, jump starting they talk quickly group get the actually that get starting -- factors some X-plus make patients. breadth inroads

terms we're among prescribers depth get the having a of of and -- the breadth So lot the prescribers. more to in success starting of those both the of growth

indications. at and look And that growth thing And nice I we beyond. is Tyvaso so PH-ILD continue just patient to go was both just actually with between I is looking The you calculating growing expect PAH. at think as and we in we're if

was XX% in And mid-teen XXXX, in still growth PAH. grew think roughly XX%, about to it XX%. we PH-ILD, in So I --

in growing that So it's nice see to indications. both we're

of first that around growth prescriber question addresses hopefully, part your in the PAH. think I PHL versus growth and So

quarters, As last think played it we for Part out the think, last D that relates to as of year. said couple largely impact, I I

saw continued or commercial over of our roughly pain are patients the we PAP patient Could patients of As new saw that in XX% about roughly type of PAP But course to more the then XXXX patients are on in over QX year. of bit XX% little and expect normal I in I or program. kind patients patients that. then QX, to to depending paying of kind the quarter-to-quarter set assistance that's our a forward. our around of patients we convert the We would bit and XX% going getting in expect are settle bounce new in just going we're around that baseline be a would generally, shift kind of commercial in.

expecting impact So of QX I'm result of the an not or QX redesign. to the in see Part D much a as

Martine Rothblatt

Excellent. have benefit is Really knowledge The from Michael, so this encyclopedic that appreciate question. an to for is all since only your may be, maybe question time one next Andreas Operator, it. Thank us. for earnings comes Argyrides. Officer the Financial much. Chief we be our there'll And whoever call. last question of you a

Andreas Argyrides

the too apologies I following question. and milestone kudos to of leading to here. and And and taking IND the teed on you expect intellectual moat I getting on I also daily Martin, the to great Tyvaso long and just don't you've fascinating to contracting and one in all, there, X and Thanks had it's of then spot on But think kudos the our apologies, quickly but behind how competitive the I going pretty first clearance financial built that. forward property My And was interesting around that? can of you're for question resume exclusivity? on up it's know for And quickly way year getting this that sense you here. question. that, the if don't team. squeeze in the put of me activities hearing some the here progress a dynamics around that really

Martine Rothblatt

Yes.

whatnot. We Well, just I'm don't the we're And into relating off IPF We launch for appreciate Michael about discuss of the and could to going you're about the you, Michael? if like talk on James. of your aspects to publicly kudos, IPF. thank to ask Andreas. so the out Okay. contracting time, really question our hook he issues anticipated

Michael Benkowitz

Yes.

if the think strategy done contracting and Andreas, related thus -- to not contracting then start that the to payers we question anticipation philosophy we of was was the comes to then we with is where it through. start the lock sure generally IPF in far. regardless directly of So rebate year have just the we've -- through, dollars potential competitor rebates, and or I I'm employed we or idea And some But rebates what behind was last that with have additional in in those to future if flowing dollars flowing competitors. really,

I stronger And It think, position. so us at us, that keeps a puts parity. think, we in

payers or us think -- into turning point, that will of the more rebate likely, dollars. contracts to off less be I at because enter disadvantage reluctant reluctant sorry, spigot that be I'm less the would basically they

to place, product we're -- really that get clinicians at discussion rebates with start flowing dollars those us the around keep like So their idea very we then we're and what's in strongly better positioned strategy, succeed get was front. with we if And the that well positioned better competitors. on then the for very feel the that parity the feel really and and patients, the to have which payer behind is

Martine Rothblatt

Perfect you, the Operator, Thank Mike. you now wrap up call. may answer.

Operator

will A & for be of the participating the by for available you in United Earnings United week Events Therapeutics Presentation ir.unither.com. today's for Therapeutics Thank Relations at webcast of X Therapeutics rebroadcast this Webcast. Investor replay website Corporation visiting section

You you. disconnect. Thank may now

United Therapeutics (UTHR) 26 Feb 252024 Q4 Earnings call transcript