UTHR - Earnings call transcript Q4 2020 | United Therapeutics Corporation

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Operator

Good morning, and welcome to the United Therapeutics Corporation, Fourth Quarter 2020 Earnings Call. My name is Kenzie, and I will be your conference operator today. [Operator Instructions] I will now turn the conference call over to Mr. Dewey Steadman, Head of Investor Relations at United Therapeutics.

Dewey Steadman

Good morning. welcome earnings the call. to fourth Therapeutics pleasure XXXX quarter my you United to Corporation It's Accompanying on me today's call are Dr. Chairman our Rothblatt, and Officer; Executive Martine Mr. Chief Michael Mr. Operating Benkowitz, and Officer; our President Chief Treasurer; James Chief Edgemond, Financial and our and Officer Dr. Peterson, Development. Vice President Leigh Product of statements include regarding our expectations Remarks future forward-looking or events. today representing will beliefs that These uncertainties actual to may involve statements and differ results cause risks materially.

with basis prepared in most Generally not measures our website Reconciliations Principles. not www.unither.com. of with GAAP are Full for Today's Today's and for available investigational other our decision-making or solely We investors comparable Our any financial latest that accordance these remarks these and information can or the uncertainties. U.S. to assume on measures and release Accepted obligation additional remarks also These progress found remarks that unapproved any and forward-looking at products. our SEC filings, suggest are uses. the are website. to to may clinical educate safe may information earnings statements. are Accounting products measures XX-Q, including intended results financial trials be of discuss financial available effective include these non-GAAP intended contain Form respect for to serve products on our update no as the XX-K to were to developments prescribing or medical on and directly risks at

and Rothblatt activities call Dr. full the over for the Dr. XXXX quarter turn to Therapeutics. Rothblatt? of year business overview I'll results an and Now, fourth United financial of

Martine Rothblatt

fourth quarter the to Therapeutics. Thank and earnings year everyone. you, United Dewey. Welcome morning, full Good call of XXXX

pulmonary Company, both really a is today. UT are pulmonary a a pulmonary a to now hypertension We and Company. fibrosis call going great becoming hypertension have

double-digit expect products markets come. these our generate for to for years growth several to two We

in the revenues a and by UT XX% posting quarter distributor XX%, a today quarter quarter over Tyvaso example, operation we still record growth revenue even one-time XXXX XX% excluding and Orenitram XXXX patterns, growth. double-digits, that quarter fourth fourth grew fourth a XX% about XXXX report fourth grew with posting For our from year-over-year order year-over-year

XX Let on our of Starting pulmonary strong we from double-digit counts our pipeline detail hypertension patient drive some pulmonary is before expect new the believe Orenitram. commercialized than use recently long-term as have from of go down growth our the me from approaches. pressures existing as of why Treprostinil patient our first below of in continue. will associated kind this the experts much artery to with with of organic all, protocol Remodulin, growth millimeters rapidly part products activities, mercury, hypertension to top products pulmonary drive three longer conventional now products existing as management increasing includes, well growth. Organic Remunity into that switching Several emerging survival on three growth our protocol shown for patients we

kind from data in all, the greater study. quarter to ever ability was and of in This year-to-year substantial And visible mentioned growth fourth growth data on quarter fourth England all, its on XX% growth our from XXXX. to of coming also based growth XXXX the pivotal Tyvaso, is of based this increased from morbidity is of clear reduce Orenitram, is Second financials past of quarter This Journal New pivotal organic awareness that trial the coming on mortality our based is XX% organic third published from from in Medicine. above. rate FREEDOM

launch this of with during device, year our expect and product, of or third, Implantable our end to and developed just advance ISR XXXX our the just which growth dry to together launched Then, call secondly, XXXX, of expect by by to Remodulin new powder hypertension. pulmonary of launch late DPI. expected around inhaler we Tyvaso of pipeline. our through from products Now, hypertension be includes, corner, Tyvaso form our first promoted clinical driven emerging These and expected System development pulmonary jointly Remunity our also for for for we we Medtronic, launch the stage all,

First of patients, product dexterity Trevyent all, fact in optimized which challenged just to the for awaiting resubmission our is FDA.

our called to Second Uptravi all, of alternative once-daily ralinepag.

version form reduced once-daily RemoPro. a Thirdly. thin, our fourthly Remodulin of called Orenitram, of and

come, up behind up parallel in pulmonary So to to ten the propel on pathways you queue double-digit three and four market ones and market, to add hypertension, the on market, that that. in three told, all are next we the about growth have the

that Now disease hypertension. XX,XXX contraindicated of known increased addition the X in its indication was therapies approved and no are we the representing or to in just endpoints to have Company primary of fibrosis existing has Group U.S. its new showed all bridge pulmonary with to patients call, made Company. a This it's hypertension evolution patients, Journal hypertension of induced Medicine treatments fact the it. also ILD-PH, fibrosis all - WHO pulmonary pulmonary from the of in patients our and trial beginning in all as nearly evolve secondary strongly being built of all Tyvaso pulmonary that in at in that, This from a England mentioned by also New in pulmonary beautiful as the results possible now reported over

in competition time it's it starting revenue but crossed climb Pfizer like know, or Company, our fingers me reflect like all It's the Actelion, this, approval FDA on are from is speaking, over roughly birth the Glaxo. for UT's without from on. again, funny April, this You pending which of to all but

FVC forced just trial a because hypertension. INCREASE Tyvaso further the in patients fibrosis. the in is as fibrosis group. bridge by seen the drug improved already pulmonary confirmatory on existing fibrosis even Tyvaso of of treatments. pulmonary in on or hypothesis That with trial, to rate indicated with the patients pulmonary test pulmonary a hypothesis had we in strong Tyvaso studies pure this FVC top our compared TETON strengthened of is outcomes disease-modifying is, that the being Phase That capacity treated no reduced our received in trial, X will Now benchtop decline conventionally data vital In

Now patient are patients accessible about being numbers U.S. the this are Pirfenidone, pulmonary or also already the population, in easily known as treated as either with since Nintedanib XXX,XXX and they also fibrosis pure known Esbriet, Ofev.

United but population, XX,XXX into we will lines to never summary, in the patients, for soon growth, be success So the next of to on approval X should of between drive in most hope hypertension, to plenty the the important our UT's approval population not phase expect fibrosis to show that by a getting to Therapeutics we our Group get the our that we that X even better. looked for total about questions. I associated April some before, there a patients. the include hypertension about Phase or importantly, like for gene of of in is COPD patients I of pulmonary launched, hoped prospects we open without pulmonary therapy, hypertension label, I'd hypertension a be Tyvaso Tyvaso some patients to patient double-digit to In also years XX trial vectors add double-digit With TETON in for some have for pulmonary growth XXX,XXX pulmonary begin. very trial pulmonary registration that I also just to in of feel and up other pulmonary for mentioned DPI, end several some confident market, to numbering year, mentioned very growth fibrosis, patients, only come. earlier

We number on experts the me have a of joining phone.

forward questions I'll please Steadman to either me So any to James for for to question, Dewey questions business free if Dr. you scientific for IT on to ask Peterson all questions. Mike Leigh and Operator, all the to lines. Benkowitz it open the feel financial Edgemond questions

Operator

Cowen [Operator Joseph the Instructions] Company. line go comes of your first ahead, with is from line open. Please and Our question Thome

Joseph Thome

And you on Thank you a transition patients discuss start little of expect Can to integrating all next over ILD question nebulized congratulations the DPI then launch the Thank on the hopeful you DPI expansion, want months, how your integration formal or thoughts the the quickly in, my bit. us the progress. version? give label taking the because PH-ILD DPI, PAH? months versus the patients on to and the Tyvaso could how after thinking you. you to DPI for XX XX for PH- I on reasonably and are

Martine Rothblatt

so for Thanks Yes. much those good questions.

and know, very been of and You realm business physicians have working both with really on. already interacting the questions they're Benkowitz in on talented Mike that team his

So Mike, question? you could take that

Michael Benkowitz

Sure.

with powder end we of purchased well FDA the around in and indications. the year, with I We're I progress of goes looking the enthusiasm really, Tyvaso to filing are excitement of think launch this as a the end think said And made that I'll that and forward Martine And the to just we'll able we're excited is tell you answer with inhaler. the And to and voucher, DPI. docs with by with year. that PH-ILD everything both hopeful there both is PAH the review applies priority there docs, April. about a we've both last be lot indications assuming into having at really dry

as product either many And as aggressively transition therapy on it start as so, to we're and preparing initiating are that make well wanting as launch to to patients available over. Tyvaso

the we're transition very physicians, the a do a feedback optimistic encouraged speaking patients after that so, be think - PAH, there in hearing I DPI point to transition able And relatively a very there want for to so, those I to very that we're launch. soon from to be at will by will be think, this quick

Martine Rothblatt

next Mike. Thanks, Operator, please? question

Operator

Moussatos comes go of line Liana is Please your question the from open. next Wedbush. line Our ahead, with

Liana Moussatos

for Thank my taking you question.

QX should revenues? think how launch, we Remunity for about So

Martine Rothblatt

Thanks, I'd Liana. forward like business to another your question, to this Nice voice Benkowitz. Mike hear morning. that to Again

Michael Benkowitz

Yes.

as think month. said. I with come in you're We're around excitement referrals lot from there's where Liana, another really of physicians enthusiasm launch, So Remunity launched that I in. We're seeing this the the market pleased Remunity. early earlier already product at, think We Martine looking see a to the

in Remodulin So of revenues. Martine we and X going of weeks, But patients break our grow to revenues. and pump continuing that to to We're the as free filled out months business RemoPro maintain report we that, Remodulin. certainly future. not by our to try Remunity Pump of over an Pump, into the on expect the next have continue the and believe is term version and those the as pump Remunity with to still MS well therapy Remunity Remodulin as it pain about, coming opportunity the long get virtue as talked that the of machine kind the generations which we versus the We're

Martine Rothblatt

Mike. much, so Thanks

just first on Remodulin, new patients that in with subcu the Remunity, have know, back ago. couple of but was Remunity. myself on Remunity, put center excited very to Remodulin on Liana, an whereas so switching from They they become Remodulin. subcu pulmonary this patients know, wouldn't of patients hold on that center You a sharing not days the put past now patients done you the I'm have patients subcu put Remunity flowed to subcu - long IV actually over putting on were differences important regularly so can't had for patients to anecdote time starting actually impressed for the is compared resistant They Remodulin, center that had Remodulin. about I There was hypertension that that or

question? come for is to just very of Remunity. that that, a anecdote I think positive So next things Operator, indicator

Operator

next Our go open. comes Yang from ahead, of Please with the line question your is line Eun Jefferies.

Eun Yang

Questions you. on DPI. Thank Tyvaso

margin it's any percentage of with that, And settle you. royalty sales-related of once XXs? around regulatory or to expect kind to do there gross Are to high you you the milestones? double-digit So owe Thank approved, mid MannKind.

Martine Rothblatt

question. to Okay. a Thank much the pretty for so much That financial question. you, me like Eun of sounds

that James So handle Edgemond one. to CFO our I'm going ask please to

James Edgemond

Thank Martine morning good you, Eun. and Yes.

we right, payment we you've we milestone under to patients and MannKind. our And do MannKind forward. the You're statements, made with milestones DPI related have use probably in these agreement achieved owe royalties historically as financial the recognized going that noted and

indications. with milestones limited pursuing are respect there to forward, Going other

gross main because our out is Tyvaso DPI. around of our of around be fully acting DPI royalty getting versus to would don't specific obligation current So for nebulizer. margin, what you terms referred patients going as question obligation very breaking necessarily overall, financial you're or kind And for we it anticipate the new of as in to kind your

basis. the based that take anticipate your modeling, MannKind, your we forward we doing going if in going that model, So I don't you you're owe think on a splitting to upon out you're the royalty come to obligations how But revenue. within something

question your for and thanks Martine back So to you.

Martine Rothblatt

Thank you much, could Appreciate James. you the it. receive question? Operator, so please next

Operator

the JPMorgan. comes line Fye question open. Jessica next with line is go Please of your Our ahead, from

Jessica Fye

much Tyvaso, how so double morning. kind the question. reiterated in press of My question Good to patients launch the release, hope the near-term. Thanks on and for PH-ILD the is the Tyvaso the you number taking of - in

you the sort is and we past have XX months. When that about in as I bolus or this think patients, something of that maybe suggested that of at in growth inflect time? line could looking something might we growth that think start of or conversely straight should over an initial think sort slow then about

Martine Rothblatt

question, Mike. Thanks, your voice your a question. for Jessica that a squarely I'll this hearing That's very business to Nice one morning. so pass

Michael Benkowitz

a Thanks, Jess. question. It's thanks. Yes, great

call last we about we talked did As investor INCREASE call, month. when the

line. think may that is really I gathering data that think belief our because through still right we're straight bolus, We now, an interactions think what I physicians. be do I initial be can't probably there won't our that with quantify it that is

I some heart up be right of have now time. a it's initiated bit XX So bit, on based what but just may start up. patients month over ramp and little may there of I you get initial think ramping the therapy. strained, and then a there's think And hearing all But of thinking - the them really be logistics back think to picture, cath. getting period a happen, than has echoed the then I is scheduling, and And bolus, it there belief still is, getting dip and and about - there's the my it on, patients referrals, getting big stuff a that an we're slower little could next to I on that's right them function getting think, will then get to - it

enthusiasm of really for or indication. has the to lack reason It for lack that's awareness do I of So that. nothing think with Tyvaso

armamentarium about talked have of a we to certainly able last pulmonary ILD. lot hypertension for month treatment about to there's As being excitement this

Martine Rothblatt

Thanks please? so question much, Mike. next Operator,

Operator

Your next Credit is ahead, line the line comes Auster Please Marty from Suisse. open. go your of with question

Martin Auster

Martine. Thanks

the much date Tyvaso of you for is did think in base? kind trying broadened the the I to about any there's just going in we're can and nice this of could Just see Mike, prescribers of where think But if year, into of kind a Thanks. category and is of fall you curious in business sort kind I to uptake one for had wanted kind much increasing how to growth growth existing early little some depth Tyvaso of as - reflecting with comment obviously - how question of better just this that as check the terms enthusiasm PH-ILD of some of indication. up a you on of you're Group well. year breadth April. seeing bit we're a approval indication Curious of and awareness in lot interest maybe X talk if that all little hoping PDUFA the coming about, this

Martine Rothblatt

hearing Thanks, voice well. your Marty. as today Great again

guessed Mike? You it.

Martin Auster

difficult it's is little track Having feels used today, the - paycheck a is we're data. to that earned referral. writing as know great. my so to that result the the which to who a able of Yeah, All there increased is the is extent off-label bit

hasn't that PAH that changed. typical being base, prescriber Tyvaso, are are writing our the being about point your to So The folks prescribers.

We material that. in a have seen not change

after We expect prescribers label expansion. that's to really that's We to we that had an going uptick haven't seen new yet. going in - occur do

by large, stocks. Tyvaso ILD prescriber base they're performance within the for that of our within that So indication. writing prescriber traditional could patients, and is the they usual the be But to PAH base, seeing our extent

do New patients. a I buzz the PAH drug lot a just the it and England think side, on of has of I Journal reminding just for PAH a to with is the physicians great around it's Tyvaso, what that lot think

Martine Rothblatt

Operator, next Marty. Thank please? Mike. Thanks, Awesome. you, question

Operator

from Our question Oppenheimer. go with your ahead, Please line comes open. Hartaj of the Singh next is line

Hartaj Singh

you for Thank question. Great. the

know Adcirca. In of James, from OpEx always in Just being sales. a a spend as sales talk previous your I dip financial XXXX, losing year's you question. XX% had you about

potential XXXX, things have going going in you're launches, on. However, to of lot a

about think question. for the forward to Thank that, then how you Just and going also.

Martine Rothblatt

Great online York. winter bad New Hartaj. in there hearing not is And treating you Thanks solid Hopefully, too today. question. financial you James,

James Edgemond

you, Thank always Yes. Martine. for your good the voice. Good Hartaj. as And question. to morning, hear Thanks

where of prior to about referred we morning our algorithm based we the So historically XX% in talked upon in budget plan budget this total. example year year, have that a you for revenues current XXXX that

if around point to to example, in an need our financial your revenues. our total to still sales, the respect maintain use we budgets discipline as decrease and you overall, our So Adcirca with

So specific within our will for their budgets grow respect we We that terms as projects. algorithm algorithm. with sure the in revenues stay talked to still question launches in of forward, budget Unitarians stay we and still Martine means about XXXX, development. that get terms need additional that product and of clinical With funds Michael to going all need your activity to on budget make within

firm our that's across that's we've built going forward. XXXX. upon additional dollars, United in across objective XXXX to is order really And we'll double-digit more need XXXX get And to are Unitherians what them the that the in about budget and Therapeutics. all Martine know talked and And we revenue all grow revenues. course that's budgets across that execute growth So of how based how

question, you. your Hartaj to for thanks So back and Martine

Martine Rothblatt

rowing is and direction. the have that so projects we everybody all are total force, like just can head nearest not center of people Therapeutics the your development, you it's we The that to there, own dearest have that everybody and beautiful United count budget have is my available business and of goal the growing to hearing sales vision the of legal, focused the financial, marketing the but the X,XXX, the the because to on really a the research And in Thanks, a experience. and grow have great grow Company product I same answer. describe career that rowing Company in algorithm Company singular a additional James the head development, resources for in everybody their XXX development

Thanks the So had aligning question. of Unitherians excellent in a magnetically you please? all next of that direction. effect Operator, has - budget bringing X,XXX algorithm question positive up kind same know, that for

Operator

comes the of with your Please Flynn Sachs. question open. next Terence line from is Our Goldman ahead, line go

Terence Flynn

questions. Good Thanks the you for growth. revenue Martine, for taking morning. about Maybe talked two me. double-digit

wondering, ralinepag, Just and on you. I sustainable there guys, you maybe for longer-term of timing know the that for the that another XXXX program Thank data? is update think, how important on late-stage potential then and enrollment that you any

Martine Rothblatt

going and first answer of Sure. to guess Thanks. Dr. like pass question, I'm which question I'm Peterson to answer relating then going strategic a of, kind to the more overall scientific ralinepag. the it to to is I question

a Group pulmonary revenue XX,XXX So of roughly about which approved kind patients. growing think as speaking, really looks a strong, reason is within it remarks growth, would kind to was X describe the not talking durability hypertension, and about to wanted highlight introductory crowded I of that in how U.S. small the ten I finite of I pond, our the single bit drugs, we're that

on And scientific in of of New be a in you durability Group April. it the pulmonary of throughout pivotal growth, Journal know to hypertension we to pulmonary - one is we necessary But their cause executed of we've grow been of enjoyed very other hopefully hypertension. England which the pulmonary the of the in this trial, disease, and depend doesn't are Medicine, fibrosis, We community, the done top in publication hypertension. that Group is Group have level well. rigor to and feet are now, confidence which feet their XXXX of approved in and our X X know, that, is which X their just We've that on pulmonary are going the

virtually we year already Now on very fragmented the we competing to or X. We side. we We started with side. were XX,XXX therapy - the XX,XXX who are Tyvaso. competing pulmonary that. mentioned Tyvaso then is need in treated of oral product. different for date, Group and treated called patients, a that. at of why therapy in as the therapy and And pulmonary There's the patients It's X drug I a patient hypertension ten the there there organically will - and me within know, of drug later, competing we for the still ago, awesome with [frontier] of into them kind their get But that two treat approved beautiful and hopefully actually was for with there revolutionary them on being knock scenario. know competitors with we you no being Actelion DPI And of hypertension had like the we Iloprost then the then patients launch, is none on you those just population in but And almost an with of pulmonary Group a a absolutely are were when another we have side. that's Mike would maybe wood, call, none inhaled their decade are in growing do XX,XXX April beginning were approved Glaxo go like because Company but this on fibrosis, to to a approximately were

with rate years. XXXX, the think decline And is is this patients which now is capacity, the vital drive upon improve mentioned pulmonary which of one then, I enrolling. study the shows our We does pure their disease we've that's not going thing, in the data hypothesis is there what currently earlier So introductory with U.S., drug, our patients builds to you to pulmonary well forced INCREASE not which TETON that data population XXX,XXX several in got from unfortunately modify reduces Tyvaso study bench-top managed fact more prospective need promising study, for for very in in validate does for that and in the actually it, with beyond all fibrosis. but this fibrosis being a the know, of modifying growth I disease that remarks, capability

you our reasonably So of and study, up the be double-digit patients that Group can for to pulmonary the balance XXXX. the the the by X, anticipated I not this think rates PERFECT something add mention X, Group the fibrosis, growing is

So business answer with to let that to me question. Peterson the Dr. over to shift or question your address scientific strategic question,

Leigh Peterson

Yes.

basically are is sites, So is of have well. majority pandemic, well. again This about studies, pandemic, and open the a in due asking the few studies you in the but quite of those enrolling were enrollment sites international is the the of to study open spite quite still the those ralinepag study - the especially are the are going trial. sites that an they outcome outcome We and

to So readout And still we U.S. have outside the XXXX a study have planning as XXXX. good We're we outcome the enrolled world. pretty have well the in U.S. the - sites enrollment, have all we in and have over of in as then both

Now remember this name, study study. outcome is endpoint hence the driven,

so, only these compare have that patients and do not the And the patients, disease two need enrolled, them to and the we - data have progression of in to but need we then collect on groups. follow

study. XXXX expect our we launch. enrolling readout a XXXX and also So [indiscernible] a We're

that for allows change it's driven peak isn't in and dropout. be study, Now and that baseline patients study endpoint VOX we'll enrolling to XX, from that week XXX in

that as both point. sooner. finish sites the the if to and on open know into could But have trial we finishing the same around continue put so don't initial maybe calculations, we many at more them as as we we're be dropouts progresses We'll enrollment up. to this time, And counting

Martine Rothblatt

for much, so Peterson. time one Operator, have question. you Dr. we last Thank

Operator

in telephone at this no have queue questions time. We

Martine Rothblatt

Okay. quarter express XXXX, so for to the Thank you this year call XXXX. really covering participating would like full quarterly of earnings you Well I everybody, fourth in much. our appreciation

pleasure was Mike been - had to Have it's As Peterson Dr. be at of great beginning, it And was. questions. good join and this the call, Benkowitz, and promised it's so morning. and James going it day. Edgemond, you great a really to myself the many a going Dewey We

Operator

today's for XXXXXXX. conference using A access will one replay Thank week participating call. dialing in rebroadcast you by available callers and dialing Therapeutics for Corporation X-XXX-XXX-XXXX, international for code with United X-XXX-XXX-XXXX, be

United Therapeutics (UTHR) 24 Feb 212020 Q4 Earnings call transcript