- Earnings call transcript Q3 2022

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Operator

Good morning, and welcome, everyone, to the Liquidia Corporation Third Quarter 2022 Financial Results and Corporate Update Conference Call. My name is Abby, and I will be your conference operator today. Currently, all participants are in a listen-only mode.

Following the presentation, we will conduct a question-and-answer session, instructions will be provided at that time for you to queue up for questions. [Operator Instructions] I would like to remind everyone that this conference call is being recorded. the Development to and hand Vice Adair, now Corporate President, Strategy. will call Jason over Senior I

Jason Adair

Thank you, corporate Abby. to Liquidia's It's my pleasure quarter financial to XXXX results and update call. third conference welcome everyone

call Officer, Kaseta; members Financial of the Jeffs; and management Liquidia Rusty Mike today Officer, General Executive Joining Roger Chief team. Chief the Schundler; Counsel, other are

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

including our detailed please up call turn now the which call Securities the for our risk information, prepared remarks, the the documents can additional your we which website. Roger over on Commission, after will to of a be filed open factors, company's Roger? discussion accessed questions. I'd and with for to our refer to For like Exchange

Roger Jeffs

Jason. look as of YUTREPIA in you, to all proceedings infringed. proceeding simply found on affirmed one at we us. believe be I as third allow asserted have have Good will to our that or shortly, to we and outcomes as to launch Notably, for patients. legal upon and in not morning, least in achieved appeal will patent firmly you at expand Thank us thank quarter our invalid been the claims point a joining YUTREPIA seminal the mission back everyone, bring will Rusty

possible as YUTREPIA affirmations favorable decisions obtain so important for become patients, goal of an payers. primary quickly is to and choice treatment the that physicians Our can these as

patients market enabled our the that of launch get and robust device. to greatly with the product resonate and two TYVASO drive even pillars the PRINT DPI. tolerability of to one, and degree low-resistance ease the after patient by primary flexibility formulation; high physician unique dose use firmly and strengthened the of feedback physicians of by are, The is Our associated two,

Firstly, degree high and the regard of dose flexibility. with to tolerability

extension We TYVASO, you open-label label therapeutic the as target our only exposures has which, micrograms which YUTREPIA's study tolerability equates of session per to in sorry, delivery. our treprostinil have observed open-label to utility different transforms inhaled profile we exposures in have – extension XX to to or radically know, a XX than XXX.X of to breaths observed up YUTREPIA, equal of X due of significantly dose may breaths limitations. therapeutic greater

the dysfunction. is are benefits YUTREPIA therapy. pillar ease to to highest side further rough YUTREPIA: augmented quickly assert parenteral use These is endure dominant YUTREPIA of from even the note utility scenarios that benefit device. as position strengthen customizable low-resistant With orientation in patient important dose achieve profile, lung of highly of this choice by as this high-resistance second and broad a obviating drug result the device oral YUTREPIA agnostic and opportunity. easy to that to could parenteral-like PH-ILD to be a envision the It dose choice. product naive the a inspiratory therapies therapies, robust of without means is prostacyclin the rapidly makes and or even over modulate parenteral Specifically, This advantage to use relevant therapy, YUTREPIA's PAH patients for a broader device-specific to enhance now range YUTREPIA patients also the which who customizable of of prostacyclin and will especially to other intolerant improved deliver flexible is therapies, further from patients a for a will given the misuse patients not oral therapy of the either patients that or and ability transitions from requirements, spectrum therapy in spillage to it in wide from from place delivery device may capacity expanding the be itself that the dosing can have advantages preferred to market need treprostinil, dose high-resistance will YUTREPIA competitor's effects able inhaler, the should low-resistance further it dry exposures. less specific device powder the poor comorbid patient to oral as patients specific inhaled of in of the of of presence uptake

that PAH to over and to call the Rusty? to quickly and prostacyclin, update an attributes populations. PH-ILD and the envision for With benefits, is product become I first-in-choice it turn the proceedings. best-in-class legal Rusty can these on would like YUTREPIA in easy both now

Rusty Schundler

Thanks, Roger.

Roger the Trial of As is that and court in by Board proceedings infringed. United are the to now Appeal Patent before path not Therapeutics litigation company the parallel of company each the clear. partes claims inter The against or mentioned, proceedings review the resolution through demonstrated the now has asserted the invalid and

PTAB on that ruled the PTAB Court ruling have patent it if to need appeal. 'XXX against be Thus, the overridden from patent, on YUTREPIA. decisions District We Liquidia overturned. able to the the decision District of received affirmed will is if the final any we 'XXX decisions the have all the of Liquidia see will Court affirmed the are be Although, appeal, approval not on do by and on

patent been XX the Precedential denied, the patent. for denial. we of regarding the denied. is If anticipate ‘XXX the and Court Panel the review likely request in now Opinion the 'XXX on PTAB’s PTAB’s District decision months will similarly a take Therapeutics the of Panel decision date timing. With United on these the our request is hand, appeal of are rehearing Opinion a XX already a Precedential underway. decisions of rehearing has ‘XXX The Appeal approximately IPR decision request for to on already would focus from decision that the the filed request

to opportunities line time are that for be this note accelerated. also We there

proceed on is Mike appeals do days I’ll argument. will process approval oral will claims, instance, uncommon overview for infringed report. accelerate the process the the we be summary, as we line months. FDA. it seek If to YUTREPIA to of of And quickly PTAB projected to conclusion can an issue In not Mike? conclusion of – any that patent as by final confident this to the we remain at the valid from to now for was the call summary could the financial appeals Federal formats have Circuit found us we of several of our not allowing decision occur, our the time pass to of possible. that the through underlying For everything appeal within of the

Mike Kaseta

good morning, and Thank you, Rusty, everyone.

XX, financial closes months documents, SEC results with XXXX. was last each the XXXX, Treprostinil see to of Injection press revenue same ended in today. related second in subcu $X.X volume XXXX today those after to quarter quarter agreement the has third that quarter quarter XX-Q issued can found $X.X profit Sandoz. June In earlier the and primarily release Revenue and market the our be you XXXX. Our be the filed Unit to was Form under since increased split will with three strong for the for million compared the million in sale of

Valley increase to per third preparation million a loss in litigation. to million compared same of $X.X for was million offset of XXXX same due the the during XXXX. the debt YUTREPIA quarter, the All personnel $X.X We net prior decreased million expenses to $X.X or in $X.XX the in to slightly third of the in $X.X for potential year third to of related million expenses quarter, was in a increase with million marketing of primarily year. to last our same the on to same to the Silicon of balance the or basic which and the of quarter due quarter. adjustment the compared a increase $X.X net and interest higher quarter to million, and million related compared quarter were to which an legal million decrease quarter incurred the million administrative fees General of was net were $X.X net a Bank. expenses and million ongoing for the last $X.XX basic loss and our revenue share gross compared a third for and commercial, $X.X to reserves, debt over diluted The development compared share of rate XXXX. by in due interest However, totaled, million to related Cost revenue expense YUTREPIA-related million. totaled we $X.X quarter a was the expenses per Other quarter commercialization Research $X.X incurred quarter $X.X YUTREPIA $X.X with negative $X.X $X.X compared diluted XXXX.

to to million over as with balance $XX.X I that XXXX. support the XXXX. $XX.X operations third cash back the now compared cash hand, We believe XX, Treprostinil totaling sheet. combined turn into on of the to our with We million December Turning as cash from revenue Injection ended to will quarter equivalents and call would like Roger.

Roger Jeffs

now Mike, to for At please. open thank time, first you, I call would the and questions. this like you, Operator, Thank Rusty. question,

Operator

from question Instructions] Harrison line of Bank comes from first the America. [Operator of Your Greg

open. is line Your

Greg Harrison

just that that the question. to Good Wondering the on PH-ILD timing the morning. our you what required, there? could know expected but what and taking no Thanks logistical wanted the be to studies are see steps said is are path additional in for get I label? necessary

Roger Jeffs

you thank Greg, for the question.

the no March required include additional the PH-ILD know, expansion of of in Tyvaso the the you – studies for exclusivity indication. as with to that label we’ve our expires FDA market are XXXX PH-ILD and So for confirmed at

an for time do. deadline. advance that sort a extension of our in safety appropriate to open-label may there’s to March that, request XXXX study. what also update But We then do approval at we that’s nothing real submit to need have So for time absent is give else of the ongoing a from us,

March further no required. we of market approval. granted us So if for It’s end the an the period are studies open at absolutely

Greg Harrison

taking Great. the Thanks for question.

Operator

Jefferies. comes question Chris next Howerton line of Your from from the

Your line is open.

Chris Howerton

there. the so taking of any first, if get curious would for if Remodulin I business generic on next questions. could just kind kind year, there was we a or expected Great. again the be guess, expect growth visibility much business just if should Thank of we any flat I you for

clarification. XXXX what respect I a for question had request just us fact, and to maybe the into could the time the guys me you it and how if call, beyond. going kind but was then are United for minute them, in on through to entertain through be for now might year understand a of line much. you’ll about dial you ‘XXX just sorry, so appeal thinking help think, a patent. second if hearing is, I’m right curious The Thanks question, took that And and Therapeutics a denied, I with an process next third getting financing

Roger Jeffs

do the Great. Good for these I’ll and and Mike Chris answer. for question. morning, is in group I’ll Rusty thanks to What

Mike, to it to how pass answer at request Remodulin So generic trajectory hearing could if question the about about line. financing we’re and looking time then then also and for you Rusty talk the

Mike Kaseta

Good Yes, absolutely, to Roger. you. morning, to talk Good Chris.

annuity. generic with as relates it more said. on previously, basis the increase unit we generic XXXX. product, We’ve as And the to in in QX an since as we quarter as as really So seen a we look said Remodulin we launch we’re – each of happy at we’ve seen said Remodulin, very of quarterly subcu the growth earlier of today,

So for although and annuity But increase we remains product see strategic in to as YUTREPIA. look launch look we’re a would a to get XXXX. of at as as flat we more increase revenue an would for growth, into significant do although we maybe we – it not important see prepare expect a very us overall, XXXX as continuing not XXXX, to modest it to that we we into see and

in sufficient us Looking $XX as quarter we cash. XXXX. get financing, runway – capital into gives feel about significant at we ended that We with the to said, us million that

opportunistic. is we’re we’ve last we done do, to and be continue over of going the will years, As couple to

We’re opportunities dilutive in financing. non-dilutive and both to look bring going at to any

best XXXX. where cash we to position leave be for stone Given same now, at bring the we objectives with our opportunity opportunities. absolutely consider we right are And capital very is the able that’s time, no will additional if an in there shareholders, in unturned feel in of we to are to we confident execute our our But on interest evaluating will that.

request with it the Rusty let So me that, over turn to on question. rehearing

Rusty Schundler

Thanks, Mike, for the and thanks, question. Chris,

and clears PTAB request. two The panel earlier, review been asked which has as they asked the original for denied, So to decision. a rehearing I They on the make in a review. Opinion ruling the response now noted Opinion the PTAB way rehearing Panel Therapeutics for United requested Precedential to for Precedential Panel things a

of that. the We appeals relates your time after is rehearing primarily denial think XX line XX denied, I take time line question request if the to like after of does – request. what the the following anticipate will end line rehearing that months the approximately the look time to

However, period XX-month be that can to accelerated. XX

as So argument the Federal to they’ll than something the opinion. months rather where earlier, after days write the sometimes decisions I Circuit summary do taking mentioned affirmance will issue oral called their within

to significant Thanks. opportunities that that there taken time period again, XX number summary It’s is happen. months like supposed So off for line. are something fairly of be to to XX-month time affirmance

Chris Howerton

Yes.

too, respect that, to previously, POP clarification those And Rusty, if process? could would offer Okay. fact, Got in you. you slight I synergies. there, process, Is those that a had think with true, is mentioned the be that, Thank some what of maybe fair? the it. in to just And me

Rusty Schundler

repeat question? can the Sorry, you

Chris Howerton

I’m the through, is you’re kind previously just think provides denial question had was that POP we me I I the in trying talking guess to and that cough. about you told process I so synergies efficiencies. The here? what my of sorry, time Is – went that

Rusty Schundler

a No, really that’s process. – it’s separate

opinion. because, that have have clearer as I So will process the several make do Opinion that to they’re helpful better our easier should a issues the necessarily know time the the But line. from a Panel that panel process for of the decision be I in of appeals think had appeals will directed think dealing the it our will to it clearer the ago, as clarify that the court appeals think that release we their in with. Precedential PTAB make We the think because indicated we record much court PTAB think appeals view original again, I process be a requests, they impact decision weeks the appeals press was. the before what we just would clearer will don’t

Chris Howerton

Okay. Thank you so much. great. That’s

Roger Jeffs

question Great. Operator, Thank please. Rusty. you, next

Operator

comes BTIG. from question of next Your from line the Harris Julian

Your line is open.

Julian Harris

Thank taking Good morning. questions. Hi. you for my

in time you denied in with I missed be position if for wondering have that for still Hatch-Waxman it the appeal if now, event appeal Sorry YUTREPIA just sense line but in PTAB favor the Hatch-Waxman you a could to a is at appeals good pending, your launch risk? Thanks.

Roger Jeffs

would, Yes. please? Rusty, if you

Rusty Schundler

Sure.

before So need the to to be able we be launch. not we resolved would do Hatch-Waxman appeal

FDA. appeal So final then all it if, we from the that’s the for and instance, was affirmed, first need seek would ‘XXX approval to was resolved

would Now perspective, a Hatch-Waxman of appeal obviously, of line. an line the of outcome But time a is still the time from the not be decision the the to getting Hatch-Waxman in relevant. appeal part

Julian Harris

Thanks. Great. Okay.

Roger Jeffs

you, Thank next Operator, Julian. please. question

Operator

from Your question line from of next Kaplan Matt comes the Ladenburg.

open. line is Your

Matt Kaplan

sense you’ve some getting I to response plays how I guess, here and your CHEST presented, the to approval. preparation that from at doctors, plans from most give the to you feedback Can the morning. and recently that your meeting us into data plans Good of commercialization been guess, Hi. you’ve

Roger Jeffs

Yes, happy to that. do

I’ll start Dr. also I’ll answer, the maybe opine. to and So Saggar with CMO, ask then our Rajeev

it patients XXX.X example, CHEST. And scenarios, So robustness highly didn’t presented the result we And particularly exposures was Tyvaso. longer-term which said per of also showed any on presented spillage. equivalents two years. the opening gone patients out extension data as we One the in and XX dropping that of for be device, in two our was patient advertently. device higher we at importance the micrograms, that we we’re breath in misuse up would data, session had dose was product abstracts robust who essence, of for the to And that showing to

of So acknowledgment and a it’s that the across to which new there’s the in patients that sort avail it the treatment is formulations. can Tyvaso, completely to opening, of displace in great to is a And modality continuum tried think thing oral greater broader does, going YUTREPIA help versus other of a And important. is reach we advantage with dose therapy. itself I particular, think talk the we nebulized that of to that

last used release, So Therapeutics' the just United example, study think they and parenteral oral as induction EXPEDITE press I to doses. called get week, an that patients what study, to clinically impactful

using do hospital. So to and three was in were the trying dose important hospital me, to by that because for is of what eight-week oral that study period, out acknowledged induction they dose what to is a drive both

dose titration So on that a problematic. oral to efficacious induction. admission is also an an rigorous It is

is back dose it sometimes just the to would induction that and to get to transition. need said, during then be. to transition the patients do in-patient the done, to that a induction from in-patient took interestingly, think headache, solve – and on to weeks, was I to The is as nausea doing to so of how parenteral again, dose that efficacious shows dose, weeks three problematic. studies And an vomiting. on you in-patient fact then So ramp getting supposed because as eight including to study And speaks took patients sort that in oral induction, one the important parenteral again, oral, an experienced fact cumbersome which was I that

through GI greatly So were trying is induction. which they to distress, – obviate which

you comments show course me, both for can is presentation of some the best maybe the conference. it and the choice clinical a I And your first perfect and used to over could be treatment as value the a pass choice on Rajeev, how that and the to example prostacyclin. publication to at So it relevant YUTREPIA of in early

Rajeev Saggar

Thanks, question. Roger. for Matt, the Thanks, Yes.

maximize like think to to to time to sort our in next launch. learnings, best-in-class that studies studies, treat capacity on launch, well these experience about would presented. strategies study lung this we'll but focus as And that concepts of inclusive gaining how that highest customizable take low, positioning clinical extension understand think these clinical explained the maybe first-of-choice from particular, as that And INSPIRE is talked PAH can data, Back learnings sort had in to our dose the clinical YUTREPIA utility launch. we open-label as be I risk prevalent experience moving really as that for pulmonary about. and hypertension. Phase improve finally, with over we strata focusing and we I to including using across bit titration well improve But disease, our all ongoing real-world also really like this and incident on forward to off device just severities focus as prior Roger intermediate exercise year our will risk abstracts only I'll profiles, hypertension to utilizing with exciting pulmonary the a little two you pending various from X-esque addition high of Roger. And of you, interstitial and the published not our and talk therapy for us and springboard several we'll also associated on prostacyclin high definitely robustness prepare with patients YUTREPIA INSPIRE rapid patients with

Roger Jeffs

Rajeev. you, Thank

as kinds the that next I of we the think thank the Matt. think different the choice saying, all Operator, first and YUTREPIA dose please. choice. to and will again Matt, is question, establish appreciate of patients for it what flexibility question, best you're and really the question, the you And we ports importance

Operator

line & the Serge question Company. [Operator Instructions] from next Belanger Your Needham from of comes

open. is line Your

Serge Belanger

the questions. you for on legal rehearing when the processes, And XX PTAB expect from for potential good XX-month about decision Hi, ongoing the request? to Thanks Rusty, a morning. guess my hear do a few, talked on you I mostly taking to appeals. for A process

the curious, that. on for to lastly, reduced? when that ruling, expect could Court some appeals some would be District just then XX Just line lines on the you And time visibility give Thank us time on whether you. XX-month

Rusty Schundler

Thanks, Serge.

through three questions in to go So the order.

the calls, as processing I the the Obviously, when expect point, rehearing the month the may said request almost rehearing internal submitted. X.X requests to think as from for months, have rehearing So we're one at date goal date the decision, this is we on submission. request months of PTAB's three we from was prior

the make now With Precedential the down, having rehearing final come request. panel the the is – decision to original PTAB on Panel Opinion decision for PTAB a path the cleared

that hope before our next decision. months it's patent, they by So have process. is to issued panel few the the 'XXX with in it rehearing weeks, we evidenced but instance, PTAB as don't a that our took experience seven within the visibility And as

to again, as hope So we don't process. visibility weeks, our is that but it's have

is XX as far – know could the to unclear. period the as when would shortened, whether I time we Second, described XX-month be that

made. it's summary if would affirmance, – advance that indication that instance, we you're periods, any the until know decision get you of affirmance. going for no one sort summary shorten that won't the of if time There's So in to a things get a is that's don't

and then go down, and know. would into the come we oral argument we three would when that's later, an opinion would days So

So a time an end over be of Suddenly opinion. period. of few the for very it just would at months would it waiting be instead the

when will be won't time So when if know again, advance period that in shortened. we and – that necessarily

the there on Court, process XX a District the well appeals the is notice date to of appeal from as Finally, XX-month from filed. think the we it's

in Our was initial mid-September. to appeal early notice of filed

So reasonable then. think months a period we again, time XX from to XX is

summary time affirmance context, quarter is is we'd to third fact, be The in to less to because summary to be I'd there some it far note put if affirmance you overturned. overturn would is And that one hoping a year. something in So can't get next Hatch-Waxman thing likely. decision, fourth a the

the necessarily appeal. So line for to are that PTAB be Thanks. same for as there time be the opportunities wouldn't there shortened

Serge Belanger

thanks Rusty. Great,

Roger Jeffs

Operator? you. Thank

Operator

time. call no turn this Jeffs, further Mr. the questions are at Roger I back over There you. to

Roger Jeffs

Great. Thank Abby. you,

to we the today coming progress quarters. again, look thank no reporting forward with in and for further you us continued questions, our So joining

Operator

conference This concludes call. today's

disconnect. now may You

Liquidia (LQDA) 8 Nov 222022 Q3 Earnings call transcript