Liquidia (LQDA) 14 May 242024 Q1 Earnings call transcript

Company Profile

Participants

Jason Adair	executive
Roger Jeffs	executive
Rajeev Saggar	executive
Russell Schundler	executive
Michael Kaseta	executive
Jason Gerberry	analyst
Serge Belanger	analyst
Julian Harrison	analyst
Kambiz Yazdi	analyst
Matthew Kaplan	analyst

Call transcript

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Operator

Good morning, and welcome, everyone to the Liquidia Corporation First Quarter 2024 Financial Results and Corporate Update Conference Call. My name is Michelle, and I'll be your conference operator today. [Operator Instructions] Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] I would like to remind everyone that this call is being recorded. I will now hand the call over to Jason Adair, Chief Business Officer.

Jason Adair

Michelle. you, Thank to Quarter pleasure to Liquidia the It's Financial welcome Results First XXXX Call. and Corporation's my everyone Corporate Update

call Rajeev Counsel, Saggar, Rusty Executive Chief Commercial Officer, Operating Michael today and Roger Chief Chief the General Moomaw; Kaseta; Dr. Chief CFO, Officer Officer, Officer; Medical Schundler. Scott Jeffs; and Joining Dr. are

as company's we are please note unaudited unknown on contain performance those including statements, future These begin, statements that implied results, will results risks uncertainties, which results materially subject the to different Before statements future or performance forward-looking and expressed well this actual our and/or achievements. call. and information, or to known financial forward-looking performance any from future today's and conference as may or be cause regarding call

For be detailed including to Commission, company's of documents factors, and risk on with accessed a our which the our Exchange please the Securities refer filed can additional information, discussion website.

to over the turn questions. call I open would the for he'll for now to our remarks, which, call like your after prepared Roger

Roger Jeffs

pulmonary dry associated treprostinil be advance PH-ILD. to and you products. hypertension, with formulation of we Good last call, or thank approval X to everyone, have inhaled currently and weeks us industry-leading interstitial the disease, earnings joining you, Jason. continued YUTREPIA, powder hypertension final In arterial Thank treprostinil PAH, or since FDA today. will our morning, our believe lung portfolio awaits for of we treat pulmonary both the what

from In seeing of and to PH-ILD. of preparations anticipation FDA potential final encouraging our the our YUTREPIA trial we launch. commercial in clinic, continued have ASCENT are optimize initial data We action in

happening PH-ILD also generate the what formulation greater seek Rajeev our patients sustained patients. to and in detail in committed is these of legal data In the and on and in fronts first, I study treprostinil, it are liposomal treat. think in addition, both so on But will and reflect we Rusty why regulatory we to updates continues PAH moment. release provide is to LXXX, open-label important to the and in a safety clinical, encouraging programs our market

can We treprostinil at which validated believe rate current billion, And annual billion and sales. to peak by by PH-ILD the the PH-ILD option. market, grow affordable growth for of inhaler penetrated driven is $X is availability approximately this this TYVASO's more in powder the at which the eclipse only PAH an rate. continues inhaled appreciable total along market run time, dry is This at with marginally of expanded $X.X

also transitioned with sales study unmet we YUTREPIA of what sales see months competitor of of in However, our data to challenging patients XXX% TYVASO from come its to continue our YUTREPIA, nebulized approximately YUTREPIA preferred dose-limiting who bulky, after UTHR X TYVASO continued need. use. and Yet, from is XX% or In nebulizer.

advantages We from seems any do totality But TYVASO more the the prevalence of portability clear issues complete to direct of TYVASO continued use of the DPI. a knowledge of given TYVASO of DPI. be may patients illogical conversion not and preventing the have that

these nearly of to on nebulizer for DPI. base XX% Hypertension patient administration. be with a patients In nebulizer upon patients days to days. discontinuation the TYVASO its XX, median study this who September, may highlighting presented treatment a Jewish initiated or initiated DPI patients broadly regard, TYVASO PH-ILD only is of the Of XX.X% of sales XX highly consistent PH-ILD importance, data, experts this more DPI, National This our continues after therapy. were these In of TYVASO observational in with XX% single-center use XX data patients discontinue or Pulmonary competitor transitioned on these of from mean that prospective the a the program treprostinil XX with informative. Of of cumbersome

and that From our impairment very with and delivers one patient-friendly, preference utilized the the resistance rather but formulation eager powder believe low are readily for perspective, why satisfaction. high formulation That's demonstrated a portable, with limitation DPI patients of treprostinil inhaled in treprostinil it new PH-ILD. not physicians and durable resistance patients a with molecule that when inhaler high choice, titratable and using lung dry treating of a the patient we the TYVASO is clearly, DPI, especially

and the YUTREPIA interactions is the UTREPIA I'd prostacyclin more clinical that that, real opportunity. share Rajeev? has LXXX. in this in observations ongoing growing Rajeev FDA best-in-class studies first in choice and become very potential to about choice With like and Y and the our to market ask to with

Rajeev Saggar

I Roger. I'd programs. questions have Thanks, our received address common most of related to X the like to

does more its see third, Second, First, expect when stand study we the YUTREPIA? LXXX each better PH-ILD observations And can emerging dosing patient I what program? our from in patients are to ASCENT where review data FDA the of in that turn. to and will titration the of in population. open-label on take YUTREPIA trial, in understand

of specific speak on FDA's question, of YUTREPIA the development as the with entered to we the first Regarding while review action active division the Liquidia the first clinic dialogue has date, dry powder a treprostinil. cannot maintained since an formulation it

be an over FDA NDA NDA last amendment confirmed years that the course the the appropriate the indication. to the has its submitting of During multiple times for add an PH-ILD would to way review PAH, of X

that required additional indication. data Also, to throughout FDA the add no the would consistently PH-ILD clinical affirmed be this process,

treat the to remain lack hopeful not very any of final that exclusivity disappointed given soon, to letter TYVASO the FDA an action following of approval. FDA barriers to are clinical legal investigation We the will the issue we that issue XX Nevertheless, expiration the action did PH-ILD. promptly granted March

ASCENT YUTREPIA the question, Regarding tolerability PH-ILD. second initiated safety, with understand and titratability December physicians the of to late open-label the we patients trial in help

to the median patients which X, week XXX.X study the dose patients, during micrograms, XXX X XX X enrolled about session over nebulized XX comparable which was of several least Tyvesa to during respectively. have is and additional session, to micrograms at the initiating The is XXX Of per have and TYVASO days. dose micrograms sites XX per highest week date study of breaths of the XX date nebilizer. We next breaths to YUTREPIA achieved X are in the

presenting size, of the medical encouraged clinical the While sample tolerability that that small more we and by data look the we in study and early year. at confident forward are PH-ILD enrollment a remain and titratability end conference this year. robust with the can profile complete patients later We future to a of the

PAH the abstract PH-ILD. next safety of American sustained the patients question, data at the third Society will focusing Conference, our liposomal and formulation clinical LXXX of from in study the on regarding the enrolled Thorasic we treprostinil, release week XX present Finally, an first with open-label

We tolerability titratability a To rapid of titrated to would breath-accentuated have continue a TYVASO, to patients be dosage twice comparable Xx XX using administered the to and nebulizer. the nebulized, to a favorable given lower sevenfold maximum profile dosing micrograms in daily that daily, dose XXX LXXX, of date, Cmax of daily. allowed our XX twice observe and study breadths

the once our poster forward We presented discussing to will look publish in calls. observation and website future to the

pivotal our vigorously engaging in to enable both indications and Phase are study treat PH-ILD single start-up we will study. of This addition, III initiation enable to PAH. randomized controlled In activities

the months the to regulatory Physician few we I Rusty? later to to like as interest At agencies actions legal Rusty globally to few the initiate this prepare is the of ask this interacting summarize months. next would forward we study with robust, in look and time, year. last recent

Russell Schundler

Rajeev. you, Thank

that the for FDA progress legal significant first barriers on of in are call there first action earnings the amended NDA front. the can XXXX issuing on quarter say saw we from The legal is the a preventing YUTREPIA. final no This which

Court, have the led Circuit previous the issued rulings combination Federal The PTAB to XXXX. removal in District and of injunction of

the XX. exclusivity In April on PH-ILD addition, YUTREPIA. to FDA expired since NDA March authority action on legal United has take Therapeutics the final to regulatory Thus, for our had X, tied

of action, lawsuit impact status worst in with Neither YUTREPIA by intent impact lawsuits these the to can clarify lawsuits Liquidia for we ultimately approve FDA's treat cannot take YUTREPIA of X our lap launch on neither patients. same ability against and final when to the to will of the While we comment the each the ongoing the FDA, that Therapeutics currently United brought both ability even and PAH in case, will PH-ILD. the indications, FDA

motion may States at preliminary parties both from Therapeutics approval April lawsuits, first for Delaware filed injunction In injunction. any United the filed XX Therapeutics the lawsuit preliminary United lawsuit, written infringement heard the United oral Andrews issue of of of has XXX regarding District in a District Court the Judge arguments on ruling time. and for the of patent has a for these the a indication. request In alleging on our this PH-ILD based

accordance in the We substantial as multiple the PH-ILD XXX TYVASO regarding and remain over physicians results period. that a there to for patients believe evidenced confident of in have describing our and treatment validity of that been label, PH-ILD with argued briefed by which something patent, more publications in than patients arguments are with as the continue decade generally doing positive covers questions TYVASO

and In FDA's injunction the for amendment PH-ILD a XX, our to of Bates acceptance on rejected Therapeutics second Administrative amendment from agency Act. to and review the not pursuant Court the States to approving seeking to label motion of District order Judge is District add did in of Columbia, these bar for constitute United the that United the the preliminary the our YUTREPIA lawsuits, action. the restraining final March Procedures for for indicating FDA United temporary accepting Therapeutics

court YUTREPIA United taking Therapeutics action though, jurisdiction, on the notice final retained has NDA. prior Bates ordered Judge both days the to the and and any FDA provide Liquidia and to X

and both filed FDA's progress. briefing FDA amendment the does was that last decision. both motions Therapeutics our standing remain the is necessary in we not confident We that have to that dismiss the motion our filed to properly the Additionally, both entire and week, the on amendment challenge to dismiss United -- and lawsuit,

available priority approval of make been Our so patients. has can remains we it to that YUTREPIA and prompt

defend to will continue ability our to call to so. the will We do turn vigorously I over now Mike.

Michael Kaseta

We PAH good everyone. quarter the strongest to believe we morning, of balance disease we a the do PH-ILD Not one differentiated cash product but ended in fastest-growing to the on sheet markets poised the and only achieve first for history. launch also into our Rusty, are and have we be financial the objectives, you, with patients. position company's in Thank what the will rare

fully Our in team is place.

and inventories are ready expanding. Our commercial

sales Our ready stakeholders active, sound relationships team and key our engaged and are fully is with launch. and all to

continue and in this believe both a transformation that indications quarter to in P&L. launch the YUTREPIA will rapid of company's enable the We approval

same the be for revenue Revenue was XXXX agreement which quarter commercialize million that see you can quarter with with our to tied in XXXX. $X.X million financial Turning for of our to Sandoz injection. $X promotion press first will in found release, results, the the compared to treprostinil is

the in primarily decrease period of gross-to-net impact the and year. due sales in to year the current The was the as recorded favorable compared prior same prior adjustments in to the lower year quantities rebate

XXXX $X.X of to the our the Cost with Cost increase relates million quarter quarter being for of sales force promotion of revenue compared our first revenue to quarter expansion fourth to of $X.X during due agreement million XXXX. increased the for in to XXXX. the same primarily

higher million, related first in expenses compensation, million million was and of to which quarter first million to $X due and increase expenses primarily compared clinical to in $X.X increase stock-based XX%, in development personnel 'XX. LXXX include in were the The increase related quarter expenses, with a of $XX.X program. $X.X Research our million a $X.X headcount XXXX or

a ASCENT clinical by our higher supply study. program, to Additionally, YUTREPIA expenses and to million increase our related expenses was $X.X there driven in related

and diluted net $X.XX months incurred $XX.X in related a in XX, fees increases million, the commercial preparation ended was compared or General or litigation, of and for The per to were the X of a ongoing to the in summary, per increases for we share consulting expenses due share, same XXXX, for million million for $X.X basic of March $XX.X compared YUTREPIA. In million increase primarily XXXX, quarter the to diluted loss YUTREPIA-related March $XX.X personnel ended commercialization loss months XXXX. of our administrative to X quarter basic net $X.XX and potential increase in expenses and of XX, in and XXXX. the first $XX.X expenses million legal in

of third our million with a between included which investor We ended in private advance on health quarter placement under $XXX gross $XXX.X first a million from hand, single agreement. proceeds the to cash care a equity royalty and

to like would to in In Roger. are well back summary, our financially I achieve turn now call we corporate over positioned the to objectives XXXX.

Roger Jeffs

Mike. Operator, that, now for you, Thank questions. with I'd the open call to like

First question, please.

Operator

Gerberry first of Bank Jason America. Instructions] question [Operator Our from with comes

Jason Gerberry

here, quickly week's the here? filing asked Bates think on context. quickly this new FDA. one how dismissed. to proper just of maybe by put want is you curious Xdays' and -- if days' give may sense both have this give UTHR Judge you seems X guess How the notice. to do don't They of to dismiss a variable last I move like how This kind FDA want to I'm being in just They notice. do

how than then ultimately, And wondering getting impact that might opportunity approval, label label secure you're variables specific about the able if broad indications, beyond and different commercial any you PAH just might we call both X looking there TYVASO? to if are could approval, think the out PH-ILD, those really just

Roger Jeffs

ask question first, timing of I the to dismiss about speak to the case. can, I'll his motion thanks question. perspective second then Maybe if Jason, the and on the take the Rusty I'll for

Jason. great the print about what differentiated formulation. tolerability, dictated of durability around pillars, Again, YUTREPIA and And in by of question, all with So that is talk which titratability, of we sort being are usability. its terms are

therapy, ability the durable to respirable low the and then uniform tolerable of and the particles the usable in which titratable, with again, through be will for a it range, precise device. end lower readily allows is So resistance and make highly

both PH-ILD to for PAH friendly So use. and patients

we seen in that be see related clinical label The label. will regard versus to will our the differentiation that what's in exposures in that their work the we've in specifically

micrograms a day times XXX in to up X described have label. will we our So

higher cycle dose as matters. we're again, the DPI. talking equivalents, what's And XX, in historical than the of about from XX much So standards across so know TYVASO routes breath we delivery, across all

the So will the that flexibility higher more of be. more dose capable the and therapy in the driving those,

treprostinil not to seeking best-in-class has as like YUTREPIA therapies but they the first we are when UPTRAVI. of clear become YUTREPIA why oral place and So will only therapy, Orenitram using that think and that of think choice do -- have compete inhaled prostacyclin, about in choice, we think -- in TYVASO chance to think formats, first starting physicians about sort should a and that's in a to in not the with also

And therapeutic a the oral of also of to parenteral for then dose of terms have those drug because burdensome where patients are formulation. off-target going getting the in the a pretty subcu both effects to time and

market tremendous the think I looking have and forward we'll opportunity very But again, clear to differentiation launch. a So distinguishable at point of launch.

legal if maybe the could logistics speak Rusty, that, with you And about the case. around

Russell Schundler

Sure.

question. So Jason, thank for you the

-- June So dismiss the briefs that and in And on there, would judge we briefs continue have rule. to of went dismiss. to will through motion motion Briefing the the from to first it round don't to is long XX. visibility the will then week have what and how him take last do

federal to take judges predict exactly point, schedule obviously, issue you But long in rule would or briefs. that the Thank he'll it's to at ruling. -- they a hearing question. for that how possible It's he'll just it's the possible a hard

Roger Jeffs

to remind in that, FDA not needed for as his just to action, Rusty the is take And decision final said comments. that

Operator, next question, please.

Operator

Julian Our with Harrison? question comes next BTIG. from Harrison Julian

Our comes Belanger Serge next with question from Needham.

Serge Belanger

think because this the And the that another mentioned would guess segment. I one, just of oral think that of maybe positioned market DPI targeting treprostinil terms differentiated I for I your product market. competitor first Can on aspect in you elaborate opportunity? the you be their has YUTREPIA Roger, don't

about quickly post-approval? the about YUTREPIA then get you past, the the are expanded has payer how force can you think been you've launch-ready, talk you're But in just coverage. how and can talk you maybe on secondly, And if field. formulary you highlighted In sales can

Roger Jeffs

Great question.

the So take we you first the and Mike, cannibalize about if payer you'll how one I'll around landscape, then to oral market, if will. hope the talk

million UPTRAVI's So per prostacyclins, about doing -- and in approach. and they're Orenitram different these sort in -- their oral of Both estimates doing of mechanistic annum about billion of is currently annum. sort terms -- $XXX prostacyclins. both generalized Different $X.X -- like just they're again, are per

weeks, GI difficult then past and that dose been the parenteral narrow from therapy. UPTRAVI much lot beyond typically in tight other the it's of effects and then that capabilities has dose effects has and and a to that reason predominant that the the curve, pretty to has titrate ceiling, top dose titrate. It -- tolerated get off-target once dose of on GI a a pretty then they're disease therapeutic dose their therapy on. dose therapies, titration patients discontinue their are therapy Orenitram, patients to not months, causes those removed so to inhaled a to progresses But takes if progress which and

and also with comes -- effects. So the off-target

position think particularly we given titratability. we that So YUTREPIA, its could

for So first again, titratable the has formulation the what inhaled for through treprostinil has allowed done print-enabled formulation YUTREPIA a time.

lot So it durable physicians patients. their for much a become and more a more has rigorous flexibility choice can and and

you they not this might has flexibility dosing, out? we in it that Well, of have don't that, Now terms pointed that be why that quite it limitations in again, regard. has asked United the so do

think is themselves. had of I they other want an the quite just table for set done as in the us they oral to to do what we don't aspect sort they that, against here want terms I fact, have detail nicely would it in described. prostacyclin, And because have of

can understand they're why you that. not doing So

not way search. hindered will that from any we in But be

site prostacyclin with patients and after having GI-side and pain of like the both market effects, are the more So of are we the totality subcu totality parenteral which issues certainly significant, the effects those market, effects go off-target that are going inhaled to like erythema. and particularly

TYVASO $X.X again, $X.X the billion, billion attractive aggregated markets, now. with with opportunity So

together. $X said And aggregate a only markets at if all I of marginally my comments, penetrated in with, point. already PH-ILD, opportunity that's billion at this you're is those we So

really really, nice So opportunity.

I a inhaled zero-sum not think not this game. say if thing about other the net is -- talk I is will treprostinil, you

people sometimes to try position think I opportunity. against us UTHR's antagonistically

PH-ILD, There's forward and what I both particular, of again, in and for in patients that's there. well, near we to look the about. there's we're And companies think to a lots opportunity in presenting choice. the future of lot do launching

coverage? you'll So about payer talk if Mike,

Michael Kaseta

thanks question. the for Serge, Yes, so much

choice. understand we've important access available think patients the But they're link I truly from wanting have we what's choice, having is also is important. critically provide and is that know YUTREPIA and choice to feedback doctors that overall to received in order will

-- been and payers. approval been engaging get I we of received with confident November patients to the have make to engaging payers back that and YUTREPIA. we've be that of tentative So that that PAH FDA, have to approval have we are the XXXX. We choice to we work think value from We've time that full in since in discuss with choice through we are will proposition once that able sure access. And

So But to that be very payers we formulary. afforded achieve really are that. good choose will that conversations where and get platform on we've that until formalized, choice will confident with approval, confident we had YUTREPIA is will obviously, that an feel patients we of be none insurance but YUTREPIA through

Operator

comes with from question next BTIG. Our Julian Harrison

Julian Harrison

you me? hear Can

Roger Jeffs

we Yes, Julian. can,

Julian Harrison

understand able to FDA FDA decision might waiting on lawsuits and highlighted comment can't that. could before. at they understand comment this on be understand too point? of a are are be that to that, you Rusty, there if But this you for making at what speculative potential comment when a is decision. I question that about time. I a you completely on prevent Sorry that make specifically on approval the expected that no the you directly can't

inspections where cycle? can current been stands? there FDA on by in then any manufacturing us additional And the required Have also the you remind

Roger Jeffs

supply can question. if Yes. the then first issue Rusty and the you'll question, Mike, answer address

Russell Schundler

Julian, thank question. for So you the

-- we are interactions FDA publicly date. So to speculate want their first, do on FDA our to with want don't where we on in process, to what the they the nor comment

is I our no to NDA. impediment legal them as before, there action taking said again, final So on

final that speak again, any action. really awaiting are to We can't timing. But we specific

Michael Kaseta

been a launch, building supply, And time. been time a commercial through Yes. obviously, to entire relating long we've inventories that anticipating for now. Julian, We've

FDA approval, running the once So be our to immediately will we grants strengths ground of product. the final in ready hit all

approval. as November included of inspection the tentative our in of Related a of our did to in XXXX, inspection FDA approval the August was and tenant pre-approval part in that XXXX, of

we've So said, completed. inspections forward have in I an building since launch commercial and up pre-approval then been to look imminent here. as And inventory all hopefully been

Operator

Jefferies. Our next question comes with from Yazdi Kambiz

Kambiz Yazdi

you for date. ASCENT the data Thank some of to sharing

guess my on open-label So titration assess? you to are study kind schemes looking I is that of question what

in the inhaled you billion kind treprostinil market, second terms of or the market? split And also overall market? treprostinil inhaled treprostinil then cannibalization a of is that projected indications nebulized of do that the in between what as market question, see -- including $X some sorry, oral that And different

Roger Jeffs

market then what stick patients? So say -- was that to I that, feel indication that PH-ILD market in the the marginal call, we're PH-ILD about DPI and that's growing. billion I'll billion going to said their nearly eclipses And and trying you we has penetration. There's $X at of their opportunity we're with last company-sponsored to terms achieve Rajeev, $X.X if test again, approaching in of you I of question is represented think intimated $X can look when UTHR billion or first they opportunity. billion just here, on the Kambiz, talk and what think earnings $X

I high some they're north just So think we it, XX,XXX, they're I but UTHR probably again, the market, it's difference number, taking call that now. think let's at says believe single low XXX,XXX, say split XX,XXX, that double-digit people if and digits, penetration. it XX,XXX, you think But

just So penetrated. marginally

lots to there So lots and grow room of alone.

prostacyclin inhaled within sure, for PH-ILD in moity. opportunity multibillion-dollar a that's So

cannibalization think oral way does orals, on we world, to it if the it the bit can markets. we infringe But little more along. real take time think that YUTREPIA the may again, move the a in then With can and that's we -- behaves really

well. $X for think billion also we opportunity as So specifically, YUTREPIA -- that's a that's

our oral, together, those of you we product of a or have the more. when think our can share we inhaled, aggregate multibillion-dollar share the So

we think, be hard I hope that So again, generate we support to that. and get prove to to thing we're is But dynamics launch the to need the to that the to out. true. approval, need do that We working to first do

terms about So dosing, things Rajeev, if some achieve you'll of multibillion which trying us of this in dollar help talk will we're the achieve to opportunity.

Rajeev Saggar

first this think using thing the of is So inhaler all, dry I regard. one here in is open-label first study this PH-ILD that with we're prospective in YUTREPIA a highlighting powder

the study Remember, in we've already conducted INSPIRE XXX patients.

So we as really no patients understand it into this and brought regard, have that the been have tolerability we past. so date. enrolled I with of X in that have we profile highlighted, YUTREPIA, and to patients the that we the and PH-ILD titratability -- In those learnings took have treated never

PAH the recommendation is, And clearly, small in early yes, saw in I patients PH-ILD? that INSPIRE And is patient can. that, think for that one is one, is the sample had population? what the study I we be dosing the the thing it replicated you the sizes, primary objective asked in tolerability this think Well, can profile answer

to Clearly, who actually to actually, XX XX to actually of what have the stronger. suggested nebulizer But gets used least the right? patients better TYVASO higher clinical X a to in is matters, like study So bit TYVASO to needs breaths, breath INCREASE looks get a signal can equivalents dose that get at who portend happen effect. patients

patient inhaled X the So importantly, that. therapeutic actually the titrate more somewhere of X some more right? profile, of which to to the XX to these patients need need least patient right So but treprostinil, XX to exceed goal this traditional study Maybe to of that at breaths. majority is the than may breaths, in the is priority

is in greater that equal is highlighted -- to call TYVASO. that thing micrograms I dose XX is which breaths equivalent the really the I YUTREPIA, to X of or week XXX now at One median is -- is intriguing think -- now of

findings from study forward the study the the end So we completing are this of I the by enrollment quite year. in think to look and encouraging, early

Roger Jeffs

ability study, can which, finish that we we the said, were what's that seeing when at important think data, investors we're do I evidence as data would for Kambiz, early in least the titrate, Rajeev the our be look So at the -- to aggressively. quite good what to

And the be, how remaining on question studies. patients other it? is those durable so And then far, are would

So people were TYVASO in we're remember, drug, I was XX-day a and XX% median Center median those of data, who National time as that started then, unable stated XX Jewish where to frame. it the only the in patients within off had continue preamble, of days that DPI dropped

predominantly off So to that much in they ability statement we're trying a I it opportunity. reasons speaks to provide The to obviously, capabilities Otherwise, much make different a differentiated worsening, and its due to which a for is that perform more titratable to And market the a that can more is YUTREPIA was dose. we're basically durable. that way. assume Jewish show worsened. experience clinical contradictory patients to came and therapeutic in lack of National wouldn't very Center And trying to show YUTREPIA that would

more good, to so So, so but far, Operator? come there.

Operator

comes Thalmann. from Matt question Our with next Kaplan Ladenburg

Matthew Kaplan

you launch the and drug? terms your in approval readiness, after commercial will soon Just how of prep

Roger Jeffs

Thanks. that answer please? you to question, like Mike, would

Michael Kaseta

Yes.

once bit for little of we Matt, will to So time question. price full get thanks the Obviously, take approval, in a list it Compendia. our

But commercial ready to from is a commercial availability, our I can force sales team, what our immediately thereafter. is go say literally

go ready within to after Our of will commercial final days be inventory approval.

a to XX full approval. So get companies I after lot know days XX they take launch to of

of approval time that or a be will after days go ready within comes. regardless final literally week We when to

Matthew Kaplan

we're you play -- LXXX future, role in us and tell terms little thinking for and of all can I on And market. will YUTREPIA's waiting that what a bit you think But inhaled treprostinil out more know approval. into about the focused a bit the little and XXX position

Roger Jeffs

answer Matt. question, the I'll Thanks that. Yes, for

a what solves So a you was what readily it it's TYVASO, titratable therapy. just look -- TYVASO I for, nebulized you if in think at not look when terms of YUTREPIA taken or was dose fixed

keeping So index, so therapeutic AUC the a much it and dose get same. more higher while titratable can the we've made we've to really the we effective profile transformed

for have a therapeutic instance, for you YUTREPIA with, as example. index TYVASO, you do than nebulized So an better

What DPI. solve the also times for and regimen, TYVASO the do we treatment that's X didn't was true same for -- a that's day

improved profile So day of but a administration. requires therapeutic the on X inhaled still treprostinil, times

really LXXX what on the lever instead would that market. make do the point will -- basically to the final of we sharing to market with our address then and market look that just So pull dominate competitor, is

for of in you overnight removal we same hours. you that formulation that therapy, because but behaved to the which if solve happens YUTREPIA you sleep, half X So the dose you a do a could the had twice-a-day as lasts essentially before go and format

If X the up, you the wake hours, time is by therapy gone. you sleep

We be which we also for will a more will exposure, that, patient outcome. provide better solve think steady-state

And it's and Rajeev seeing day treprostinil. in is extremely times seeing X a -- as trial, hours then LXXX a X well Xx We're the the and BID as the same tolerated, Rajeev as AUC that. a that said, is it inhaled that's just we're open-label XX given same said, that lower Cmax because has is to

far be. its profile is we what in so So target wanted exactly open-label work to this

to of point preferred the any? that if with that the at at regimen try does. Operator, just solves this sometime we still We'll LXXX. INCREASE we're while But YUTREPIA approved because now that become next that year, that start frame. time hard for the get benefits time, giving think the all XX the in question, done it to will therapeutic study to work and in going TYVASO end replicate And

Operator

to to questions. Thank for no the There back like over further closing are turn I'd remarks. Roger you. call

Roger Jeffs

the My become Great. preferred very the providing and for you will patients for time critical time for it Thank morning. what operator. address much And you questions expands. a be we our earnings is treprostinil hope as feel that the inhaled to we call, product we inhaled on you, thank a treprostinil, next is at rapidly this will market

Thank today, speaking soon. and you forward we us for to joining look Bye-bye.

Operator

program. does participation. your for you Thank conclude This the

disconnect. a may have day. You now great Everyone,

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