UTHR - Earnings call transcript Q1 2019 | United Therapeutics Corporation

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Operator

Good morning and welcome to the United Therapeutics Corporation first quarter 2019 earnings call. My name is Michelle and I will be your conference operator today. All participants will be in listen-only mode until the question-and-answer session. [Operator Instructions]. I will now to turn the conference call over to James Edgemond, Chief Financial Officer of United Therapeutics.

James Edgemond

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

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

of an activities I first over of Now for Dr. XXXX overview Therapeutics. the call financial will turn and United the quarter Rothblatt results business to

Martine Rothblatt

over triple myself, Mike few currently directed our then Therapeutics X,XXX years. the few next to we give quarter up Welcome prospects our questions from of first like call. to good the phone helped earnings for I everybody. Benkowitz. morning United you overview next James open would years expects XX,XXX President the over patients for of the and that to during number to James to Thank and an XXXX lines or

technology because each breakthroughs technology use therapeutic thousands of and technology enable each this Remodulin, Tyvaso of Tyvaso breakthroughs breakthroughs three have for confident are that five Orenitram technology of platforms Orenitram. There Remodulin, new four and for main their our achieving are We breakthroughs three will with for patients. infused new by been

addition a tripling over also entities hearts kidneys, national chemical unmet years, and of lungs. the dire have of expected needs to and new In next oncology, transformative new medical this solution manufacturing few business deep candidates transplantable the fibrosis for organ our hypertension in a and in of we pulmonary pulmonary product pipeline shortage for

which technology expand me our five this the next we over now Let for triple few breakthroughs part on years. our Remodulin, expect of to business

and for that with system problems is registered a life-threatening treatment with completely to Remodulin, label. a such the require two the enough monthly implantable Remodulin the in opioid subcutaneous hospitalization risk the eliminates sepsis biggest rate significant revolutionary is of bad it pain First, technology that product

thousands will We implantable half launch patients using expect breakthrough this this second the Remodulin in pulmonary year. for to hypertension up system many We believe end commercially product. the of of

biggest is accidental pump dosing. existing of Remodulin bolus alarming pump subcutaneous product an semi-disposable RemUnity it extraordinary two and eliminates problems malfunction the Second, the for pumps, inadequate because subcutaneous with

rate subcutaneous worry the among of our patient every emergencies pump receive acoustic confident sensing our in at two fail this one every approval feel Current once XXX(k) hospitalization volume RemUnity or within to expect one for two. RemUnity awful two We pumps pall breakthrough of pump the week I fear causing subcutaneous population next months. to and new eliminate days patients. this to will that the

they without are profile shown that a be patients. of in all die half hypertension chemical reduced to complexity studies. much entities the trying new X recalled pulmonary Remodulin unable Third, current Remodulin of handle It patients our RemoPro pain, Phase sepsis have of because and pain pro-drug Remodulin should ever

integrated Our product Bluetooth with they as be this available three to connected Remodulin intravenous new opening Remodulin patient's compliance, seamlessly the requires pump. that subcutaneous nursing issues will device of the flow with and are eliminate smartphone to information dosing therapy. if patients ultra-smart the thousands all Fourth, This on of their many payor up doctor, Smiths will drug, all will it, new so well. Medical status, new dosing a seamlessly and RemoPro through payor staff our partnership

at or years. source to let major for and business patients to over mentioned change to which of with be mean life For any that handle. of any by into time pump the are rising are it expected pulmonary Remodulin. the and I Tyvaso making its pump Trevyent they integrated happy extremely Mike, parenteral our this use our size, about Remodulin way, we seamlessly and XX-years expect to to or who of the Hence, with seamlessly questions James, a will age the these old, our all questions kind its which contribution of patients is not generation smartphone tripling hypertension patients integrated topic. to is earlier, with first of in their or and about There the the pulmonary hypertension will connective be die few the a on their of actually their of new patient to ever open either I Trevyent, many, as for me our Unlike make President based breakthroughs to XX,XXX like causes very the of pulmonary point, all the without the connective trying by all of smartphone. of will hence existing the pulmonary difficult of next hypertension lines makes would pulmonary this ways to tissue point perhaps It's But systems Fifth, have most disease. answer deliver hypertension. simplest disease medicine me the any or impractical the half parenterally. one completely And of out our easy that CFO is Flolan product certainly of available many definitely common Orenitram, patients tissue to up although hypertension go that. this operator,

Operator

Instructions]. [Operator

Cowen. comes question Chris of Shibutani first from Our

line is Your open.

Chris Shibutani

Thanks Good the United very morning, and much. team. Martine

that commenting for reference little As we these kind What quite to A make color of little think patient Is and from I taking prices. from. how it's disease around that, are regimens? a talking bit us, different patients additional to challenging quantify of also that how this where numbers that bit the you about going are shifting patients had classes? are there. since competitor we that? are that you more talking that you from a a typically we about? haven't bit these Thanks. thinking we about you units source PAH I then patients where had And are about to some have And you Are the for think you price you business, about I modeling, you talk sort precedent are that's Can of when forward? and increases us coming of think is are think

Martine Rothblatt

morning. Chris. Sure Good

hypertension. So of currently the point number to numbers, being pulmonary at are is with the currently physicians number regard for XX,XXX patients. starting by is that patients treated And the who

first the start to with. So number that's

my without that the I remarks. reason in therapy. the introductory that patient The I placed very second going in reasons that mentioned die approximately on ahead number for are large ever is And remarks gave being half introductory population number the my that and of parenteral

is, patient say, of to what patients in So north currently population, a XX,XXX there would addition treated. one capturable the patients being new

XX on from of mind across pulmonary was the published third XX patients of the university hospitals, the data entire keep years. hypertension to More diagnosis the think, pulmonary hypertension survival of years. generally is which survival time with mean best trial the clinical in to major is around patient number, the mean population At varies mean is a The five I duration most years. shows mean the survival from therapy. The five treated important patient about centers, the

So those Tyvaso of or what each failing basically patients it you if of the patient the X% or you XX,XXX X% seven more kind medications their eight like more mean needing that aggressive the therapy. patients and know needing and basket you to be, means one-fourteenth are about of and are year middle could or up go basket. there oral The means ending would Remodulin on and is ahead in numbers progressing point speaking of survival, population or took that roughly constantly about that of years who Remodulin

to offer needing better So of oral we hypertension. ways parenteral for out every years something of therapy no the one of is And there all and we know nobody severe a pain. which place significant to not the on is of the of hand very the and for does is a sepsis other solution which all complete wants need for Remodulin been there of pulmonary delivering working implantable vast implantable therapy. system end going be we the is problematic does basket have we develop the are pain on the out care Unfortunately, patients, one for reasons realize dip to Remodulin unfortunately able to want that. better again, that risk to so medication that, to cures the takes just up the single there provide go a provide for hard approved, that And is them system many hand Remodulin into not and majority

the flowing population this patients patients this intravenous entire coming are always half holding forms failing or Uptravi, are what the our whether of both delivery going fearful we and now having of second Opsumit, who as there who of drug. So are have the the out in, of subcutaneous from of right either have it's new well as you to patient

gives mic And metrics you talk now Chris. about of pricing aspect. me parameterize to let with, turn Michael to the that that hopefully the So lot to market over Benkowitz a

Michael Benkowitz

I challenge little think which around that was taken your I have unusual increases would Martine. Thanks bit. we Yes, price some question a

respect with a in, digits. that Martine I consistent back price has point we increase her at we it single in fairly guess, look you was at the we to if really about And since I our Orenitram, in talked last the and Tyvaso reflected first history just investments that opening. annual Remodulin, in low taken Remodulin technology respect been years had increasing that delivery increase. eight that took in year, we have an the been increases taken price With that taking have but think

And and seriously good responsibility so, very be price care our increases. that system very stewards are have we drugs and expensive. take that health of think We our then the we we moderate understand to a very,

So we don't take aggressive price increases.

patient support and side, do make to them our lot a of we drugs the affordable. help things On

we reason we for program can't all patients assistance able generous copay of give of for them have, our free. have patient patients medicines for we afford for think, whatever if for and then commercial products our our We are they all our a very so to to that cards

Martine Rothblatt

Thanks Mike.

question, operator? Next

Operator

next Liana Our comes Wedbush of question from Moussatos Securities.

Your line is open.

Liana Moussatos

modeling you questions. metrics Solution? taking Steen for Can my give you some XPS Thank and for us

Martine Rothblatt

you, increase use Thank there transplantable to probably FDA's the a guess misspoke vivo for we bit system that those said of beginning who I on lung the call, full the is That's may hypertension. at Liana. Friday not no little for the commercial cure perfusion approval on we that reference be received supply ex I Yes. a when lung. I pulmonary for aware,

and lung that a year few are now done there for ex X,XXX U.S. pulmonary fact, there transplants has marks. of me about number that shown each many push flat-lined were proud has year to lung When lung vivo under cure XX% our up head we years effort, lung we the data in And able the transplant Statistically, a available. a are transplants started been very the just In we lungs increase hypertension. have completely lung was a is number lung that But excited technology for in very the transplants back XX to enabled of each that total lung our after transplants X,XXX going this group transplants year. of perfusion

and a by that the So what center Clinic. the fly center lungs Silver the transplantable to lung we then being Have on the at of that time, lungs in our, technicians use, them to bioengineering Mayo take surgeon And transplant by restore bioengineering our that super our that visualization expert way, XX% lungs as lung here at and centers condition authorize it's shape call, those lung lungs high Spring bioengineering Spring in provide patient. August this no lung to Silver States. able and the and these of second to Fly this August, centers. the their no access network transplant for up the assurance a see throughout here the further operate to these than wants actually our them one well-trained themselves operate to doubt surgeons to and phones marginal in for lungs center bioengineering giving are center they more actually tabs the open and on will come at these United would excellent look transport then and them can at Mayo the inside that the resolution lung the transplant whatnot

has in here a XXX% our a out allograft of This hospital. have is if as received at have accepted have had as just In and donor the successfully part transplanted they same bioengineering that operated surgeon patients the transplant we really center, on fact, well of those once hospital from walked lung lungs been the of the extraordinary. another lung an

Francisco, was actually was a to the Francisco bioengineering as use donor, had lung way San give last from marginal wanted a to Spring, flew nobody Maryland Silver San where lung, Just it all in have example, a we there here center. to our an it have week we just transplantation,

lung worked the team on on take to I patient. waiting Our had it morning, the said, new additional And the transplant then who highest it. that going for the the several am successful that lung surgeon a patient the on we lung UNOS flew like transplant lung with looks a me. on position hours night. was By for list a it through and

perfuse Steen lung technology a and we The like are which solution exact around the to it the and definitely while the of ramp commercialization used it's is to a working vivo working the So give in metrics up. beginning is it. on condition that's Solution

even and of normal interesting could thousands we never customary for that As we commercialization exact of that is where give it final medicines clinical been the also believe get of clinical reimbursed still the me, current, because tried the in that's with kind approval Friday. thought a But I The Liana. trial kind it's unlike pricing just transplants trial, pending in got Medicare dollars, of or an have space, is to tens pharmaceuticals actually we approval on to magnitude, you the just a in and phase. of that we order in

were So receiving we $XX,XXX, order set even we in our clinical the reimbursement like of per of on per $XX,XXX process. trial, patient something that lungs

think be Liana. better things on fully a clinical trial. just commercialized the the was And that So I question. Thanks, next bit will Operator, in scenario.

Operator

Fye of JPMorgan. next Our from question Jessica comes

line open. Your is

Jessica Fye

FDA to in there. in for I to Hi going Has from morning. was had do question. re-file the a Good there so, with working on you back if what January need that? was my you pumps they heard suggested pump, in DEKA if taking think clock. finding? the Thanks are plan in wanted I the check a on DEKA to the XX-day which early the re-file particular from there? work Is new year And more to on,

Martine Rothblatt

Yes. Thanks Jessica.

back expect heard already approval re-filed. two re-filed some been next the the month we It within was that they ago. is FDA. yes, the answer to pump weeks. one have And the from has of So It

Jessica Fye

you. Thank right. All

Martine Rothblatt

Next question, please.

Operator

of Our question Suisse. comes Credit next from Auster Martin

is line Your open.

Unidentified Analyst

morning all. on This quick Hi. had is I Marty Good question. Auster. [indiscernible], just for a

additional future If you the pump can that you on there Thanks. going very or the us. Is in give to to helpful additional a update on any manufacturing give us /refresher would pumps Medtronic that degree? that are quick be expectations and term just for near us supply? chance on some color ISR But the in anything

Martine Rothblatt

Okay. Great.

we received FDA commercialized at year, since program last approval from a the UT. As our become mentioned that's

to that. question second going to launch this little over half you And give commercial of year. color am to Benkowitz in I more bit the the turn about Mike expect We

Michael Benkowitz

expectation and to very able we implantable the guess Yes. associated expect FDA we the that on we of receive soon Yes, we of last I from with their issue are Martine pump down the launch. clearance system Thanks They be issue and remains last as said, they then filing. a second and in Medtronic expect to is, Martine. our is that will had conditions will will their XXXX. launch series approval the half that that

launch, Our sites about implantable trial launch are preparation XX to we as have the that started system. already sites. plans And talked clinical previously, the have experience for with with with start has those

looking and year. the that started to And by And are soon go another of and to clearance the getting expect the implanting already so the do we able we from and process be to as running have will to we most also as end start are immediately. then, of sites up have XXX FDA, and almost

sites year, do through So by the will implantable we end the XXX of implants the system. can the roughly have that

Regarding there manufacture has Medtronic it. no system any is such of increased on have to current IV that that wants the really limit patient implantable supply, they number able that been have practically supply. pumps the the can

we are we And supply. next which available have wish patients sometime again so Meanwhile, there future any to of launch year. of expect working be will be on will And with to their version for pump next implantable the that supply the generation they that system. there plenty

Martine Rothblatt

Great. please. Thanks Mike. next Operator, question

Operator

Flynn Our Goldman comes Terence from next of question Sachs.

open. is line Your

Terence Flynn

me doing the Good previously Ralinepag. about just on wondering, talked Arena I had Hi. two question. a for I potentially trial Thanks Uptravi. head-to-head Maybe know taking was morning. for versus

of be you. the just your guys you for then to And incremental Phase give on spend program R&D X support that, if can consider? curious color you that's terms Thank any So I would would to something get thoughts still in Ralinepag?

Martine Rothblatt

Thank you.

head-to-head not present, we So trial to do with Uptravi. planning a are at

an be adequate We agreed full trials basis Arena the pivotal for that the with our three hands approval. to with have had FDA

FDA's given with based in different whether to the those In there trial results any trials, three significant trials achieve two statistical just statistical were highly trial drug with are on fact, view high one significance. ways for of the significance statistically seven pivotal or in out or approval

to data approval our advantages that's The of its the first of terms in that actually enticed in us to we place view, diligence pretty And was entities received that the Ralinepag that many we are interviewed. So process same Uptravi. due the there in different there. from compelling, during over different gain ways kind feedback acquire the

providing are not and the a I But sure trial. be United always information. really interested doing significant always what in head-to-head such would at we So cost-effectiveness we are am open-minded of Therapeutics clinically

definitely regard we don't means. possibility increase that that believe due net R&D, of So really With is R&D to I to our not by acquisition would at the incremental in any all exclude there any spending Ralinepag.

We have out and Ralinepag products just one because have the trials are up pivotal right of that To our pipeline trials. and out now, of are our in to coming obviously beginning Phase constantly and you give begun. ramp X in example expenses

now. For example, already first its the trials, the largest OUTCOMES has patients the trial of enrolled

are expenses up. those ramping So

the wound BEAT the the hand, beginning going BEAT are have on And rough On say, is savings right down cost down. the Ralinepag. expenses Obviously, I all we to other trials now. trial, whose company expenses within our on those approximation, to wind would are other the a equal the to of almost

interstitial is to fully is about That's almost our of which patients in with INCREASE trial trial, winding lung enrolled. just Tyvaso Another down disease. start

wind beginning So down. on the expenses those are

a several any CFO, Ralinepag this coming keep is a should R&D due And conferences steady on of healthcare to spending. our has going all. And at believe of of So processes as a James, times, we expect kind coming our at state I kind philosophy always spikes out not you in, guided on.

Next question, operator.

more have question. we for think one I time

Operator

question UBS. Gould Our of from next comes Carter

open. line is Your

Unidentified Analyst

on is for question. Thanks for our This Hi. Angela, Carter. taking

additional are Remodulin a impact across buyback? and that capital about share business you investment how generic does development, R&D has that allocating thinking Now launched, how

Martine Rothblatt

am about you you Chief going talk Financial Okay. to talk I ask, capital, about our Officer. when

that. So is James here going to answer

James Edgemond

Martine. Thank you Great. the question. Thanks for

an be R&D capital generic priorities our continue first entry Our will in as described capital Remodulin. opportunities. remain a to investing allocation unchanged you even And priorities of

our described, mission. our Ralinepag just in and trials, to of clinical Martine other As at opportunities the looking trials clinical business terms really around support

in creating And invest Second, development value going we activities. business share repurchases. to are third,

are consistent priorities forward. Thank allocation we have discussed before will much. and so what capital going you with those So be very

Martine Rothblatt

look be healthcare James. you earnings seeing call at to detail. Thank you and could greater where the things upcoming joining dealt into you Thank first everybody some conferences quarter we in forward for of our

in August. So the Conference them at June, a next for I Thank the be York there will are number myself in of in July. call. up New Wedbush joining you coming everyone

Operator

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

may now day. great Everyone You a disconnect. have

United Therapeutics (UTHR) 1 May 192019 Q1 Earnings call transcript