LQDA - Earnings call 3 2023 | Liquidia Corporation

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Operator

Good morning, and welcome, everyone, to the Liquidia Corporation Third Quarter 2023 Financial Results and Corporate Update Conference Call. My name is Therese, and I will be your conference operator today. [Operator Instructions] I would like to remind everyone that this conference call is being recorded.

I will now hand the call over to Jason Adair, Chief Business Officer.

Jason Adair

Thank you, Therese. welcome Corporate Liquidia's Update to Financial Quarter pleasure and Results Call. my everyone Third to XXXX It's

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

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

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

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

Roger Jeffs

Jason. Good morning, for you, thank and us. joining you everyone, Thank

marked serve. quarter PH lives by market patients the and committed to change positive was the company, future and third The of are we the steps of to the continued

hypertension, or We lung PAH; promising PH interstitial fastest-growing arterial includes area treatment and a marketplace: the with that of pulmonary associated disease, inhaled the have or built products we pulmonary believe of the portfolio hypertension most in the PH-ILD. treprostinil for

long treatment XX durable times experience now X.X per summary to the our doses equivalent best day. In this, as patients can powder when effort, as years of breaths pocket-sized from has for a simple-to-use, titratable support YUTREPIA to the X to of of a clinical shows have inhaler and to already where Many regimen. our first choice treatment using treprosinil dry you we've treated know and low a of titrated be, recent prostacyclin YUTREPIA, how be open-label formulation adding patient's that powder dry and TYVASO potential

been demonstrated therapeutic to utility equate I want inhaled ability the exists. emphasize, prostacyclin of routes significantly with dose upon that and potential to treprostinil doses outcomes. administration dose the all use across improve and patient index broaden YUTREPIA's better of as it it has as higher has to matters, higher currently

same the delivered clear called minute evidence nebulizer. seen program sustained-release day, using in with hours. LXXX. treprostinil delivered X drug we've simple the throughout At next-generation, sleeping This in consistent formulation in liposomal time, per approximately promising portable administrations of early including inhaled X offers during is titer dose benefits breathing more exposure Each breath-activated day our a

higher but doses We to times pain data per at day preliminary including throat to titrate XXXX, in been the that share who able breaths study any TYVASO have comparable to have without to this for month. be patients and the more path much only events during our of the expected to calls, moderate sharing in very Type future FDA informed minority mild next which We with patients. our scheduled earnings on our safely have to XX transitioned suggests and program development adverse conferences in TYVASO a look from reported by C plans will data daily of details date and meeting open-label doses, X to forward registration

good or scheduled by from PTAB. and appealed supports currently that preventing story to decision injunction legal full patent, is that arguments events. focused currently being X. The with excited on by of news Appeal we All favorable found YUTREPIA. that approval 'XXX patent PTAB's program, invalid Therapeutics is has Trial recognize United the Board, now greatly oral the become claims The FDA There's is near-term granting just that we legal very were of investors' Patent for most be LXXX the While patent, our of a are our simplified. about single attention December

few a argument affirmed, provided. to the the as written We oral issued our execute the final the is approval, injunction quickly as request months after Regardless, days arguments of possible. or quickly market In approval be lifted PTAB's landscape seek oral as to just and few as within we from is PH could if we formal expect after affirmance will if immediately change the decision some will FDA. decision an event decision of where the on have the a the is such of plan granted, the

investors to For commercial this provide our an broadly reason, introduce update I have asked to our regarding Officer, Chief to himself Commercial our Scott? and Scott Moomaw, preparations.

Scott Moomaw

Roger. Thanks,

Orenitram introduction brief of more and the and that teams in pharmaceutical have in industry than for XX met, a launching not XX those had market, commercial marketing treprostinil years I I products. yet injection. launches spent the of the the of those building hypertension and As treprostinil Remodulin, including ultimately years TYVASO leading pulmonary I've products,

a our for strong really Liquidia and others, Since RareGen, Roger I leadership. I company commercial management market potential commercial ago, of team launch Liquidia. been across and years when and strategy upcoming sales built I've marketing, senior with with team our Two joined a building access the merged then, co-founded We've YUTREPIA.

pharmacy prescribed and suite team that On is access high-touch and access of services, the by full services supported a a marketing a program specialty will including be card patients are market patient YUTREPIA ensuring our co-pay side, who program.

sales exciting. side, On very the

an passion selling XX of last majority with Just reps the products, X force previously. onboarding ever. PH our of share the we suffering about academic to any the and Collectively, Liquidia more is is offices, field progression. The for supporting patients sold that widely the disease at their complete products center disease my community of were from stage now increasing the sales know who of awareness injection team rare having We team physicians in of diseases. helping rare month, patients all team our years to treprostinil want and here for pleased has of Liquidia average sales than

approval. proud preparation ready our is am final PH-ILD of YUTREPIA I to result in date, and Liquidia that PAH well say a FDA both and to launch positioned upon to As

review pass to I'll the quarter's Mike to Mike? over that, results. it With last

Michael Kaseta

Thank and Scott, good you, everyone. morning,

third results found this quarter the XXXX financial be release press and can filed morning. XX-Q in Our the

As activity see, you on judicious value-creating in will a spend to and operate manner. continues Liquidia

ended months the third million quarter cash, We $XX.X burn with in this to a $XX.X net X million year. the of first equating over of

due injection offset period prior year. net the million quarter, in the adjustments, gross revenue same same lower to from compared to compared $X.X During year chargebacks favorable to last and treprostinil which the quarter rebate quantity the to sales increased

third due to amortization commercialize lower of XXXX, million primarily as with intangible R&D to to expenses due Sandoz quarter of million, to the Cost clinical headcount $X.X of asset $X.X sales injection. decreased quarter slightly extension and program to of $X.X agreement treprostinil compared to included in support an increase the XXXX the recently million spending and to increased licensed advance second supply, quarter compared increases. commercial LXXX build were prelaunch our

expense. General and ongoing and by administrative quarter million in expenses our to for the same potential of XXXX. to for commercial YUTREPIA expenses an fees third primarily personnel for was XXXX The million the were million quarter compensation driven the preparation of related $X.X litigation, increase in and in legal stock-based $XX.X launch increase compared of $X.X

events through unfold. continue the opportunistic year legal over like same events December the the and As line regulatory also turn the now we as apply while of will to beyond, to into time financial those to call we look Roger. being and manage back I'd to discipline

Roger Jeffs

hope I level Mike. enthusiasm of you, our Thank hear investors can and excitement.

that full enter benefits We journey and, upon YUTREPIA approval, can promote to are now better. the marketplace patients their in feel the fully provide to prepared to

open like for now would With that, questions. the I to call

Operator

Our with Instructions] Bank from question [Operator America. Greg is Harrison of

Greg Harrison

the any would be efforts. opportunity segments how launch a ILD? And thinking in PH-ILD there learnings competitors' terms gained addressable and Wondering market from focus you're for that in about in are any size of your you've the of your

Roger Jeffs

Thank Greg. if the wouldn't of you for your that could Yes. you you Great mind, question. view if Scott, commercial give question? question,

Scott Moomaw

sure. Yes,

So for about market patients. is we prevalent feel like market PH-ILD, XX,XXX the the

in of quickly. physicians, there's here market see this know patients think but recognize As -- significant probably that we it, that all center also companies educating who space should but unmet not a patients need. you already; these physicians may potential and actually We community grow that see because X these the

about here. addressable. that chime we can Rajeev if but he we're significant in a We excited differently, sees all potential it. have think it's think So that we

Roger Jeffs

on comments further any Rajeev, that? Yes.

Rajeev Saggar

learning Yes. to know, the hypertension. you the patients just this and there's over of of unfortunately still of develop condition continue one interstitial Greg, regarding pulmonary those types which patients, highlight these We type of are classification obviously as different lung diseases. to XXX of

hypertension. pulmonary diseases, we pneumonia, But hypersensitivity develop focused emphysema I interstitial that identifying combined fibrosis idiopathic think categories pneumonia. broad inclusive categories, portend to on pulmonary autoimmune These are and the remain of

also earlier these earlier are and on opportunities, impactful be quite focusing So diagnosis believe, the physicians and we these treating treatment for who will cohorts. patients

Operator

Serge Belanger Needham. Our next from question comes from

Serge Belanger

the on LXXX one First program.

the So think conduct get what Type that need would PH-ILD? needed a what a meeting is to terms the to month, of going into open-label you'll open PAH trial, your Or Does are the expectations placebo-controlled filing? and support next C both ongoing -- filing? you in studies to in

Scott, and the for two. there follow-up base between a is the the previous how how about second PAH overlap and then And on kind much question. just of PH-ILD different talk maybe for maybe PH-ILD question, prescriber is Maybe

Roger Jeffs

registration about strategy our wouldn't -- discussing Yes. kind the of and see Thank the what you, LXXX at Serge. least with as and you path Rajeev, our talking we preliminarily, FDA. what we're if forward mind

Rajeev Saggar

Sure. Thanks, Serge.

primary near goal the robust meeting them be study profile regulatory advancing study FDA clinical on with lead ongoing that's clinical PAH believe prior that of of discussed inclusive date. proposed to of we've as our We placebo-controlled of So of LXXX And paradigm calls, overall single is using enrolling C the achieving safety III in and currently or that's Type future. to with Phase adding a to LXXX, approval PLD this PH-ILD both open-label the path the will the Scott? ultimate a program to that endpoint discuss in is approval. what of the the will

Scott Moomaw

Yes.

the the may pulmonologists, that other as are mostly of And labeled not community usually centers, forms treating Dukes, expect. treat the have treat only or hypertension. PH-ILD ILD as it's then physicians, pulmonary PAH PH-ILD. diagnosing PH-ILD et just what's you So the the market, HCP but well excellence, Mayos, you not the cetera, The be as treating of they might PH centers but

Some it be if X,XXX maybe be would about those of see, prostacyclins think of prescribe PAH not do or who we more targets you serious us doctors X,XXX targets having meds. the numbers that would overall, the

that, that they infer treating So are not would you from PH-ILD.

cover adequately. we're So more than those all sized to of

is X And bit a in little the the so different obviously. goal segments different,

they probability that sure want then the in the sure And in that PH-ILD reaching make the the PH-ILD And you are drug. excellence patient community, they'll they're and severity that of our that to gets aware to centers, diagnosing and you of center When a that's sure want you're if when they're But you're they let's if great. that, it. can. of of to it, that treat make won't, make

Operator

from comes Yazdi Kambiz Jefferies. question next Our from

Kambiz Yazdi

kind of being discussed past, could of expand of what that as 'XXX us YUTREPIA use Maybe choice. a the you've launch. you the the patent? of is in especially a potentially can method you of a first status of ahead then Roger, second thought, question, remind prostacyclin kind potential And on

Roger Jeffs

the for Thanks question, Kambiz. Yes.

the you you will choice. it about potential YUTREPIA could of that And the if the talk then, maybe Rajeev, first can if maybe as pillars status about Rusty, Rajeev? of position talk will. you prostacyclin question, help So

Rajeev Saggar

Sure. Kambiz. Thanks,

market. So rehighlight, will well especially in device. enthusiastic as the quite PRINT first, market, a in using believe remain as our quite We formulation just low-resistance this YUTREPIA be to PH-ILD differentiated that about the yes, we

our discussed pillars offers of We that key that are tolerability. have always improved some YUTREPIA

dose remains study. As the Roger extension study, we as alluded which that in to, highlight does is continue our to quite titratable and known matter, open-label YUTREPIA INSPIRE

doses this reached of we importantly, doses clinical most long X exposed will up to use YUTREPIA And show which to equivalent -- TYVASO for we in highlights these in for being with of YUTREPIA with with durability these both see and And as the PH all PH-ILD. patients improve now the remarkable believe breaths quite believe being these itself XX times now is years, X.X of this patients durability used with we and compliance population. a have We which in outcomes portend to of as high patients. day, just safely

Roger Jeffs

you, Thank the if Rajeev. Rusty, of speak to you'll status Great. patent. the

Russell Schundler

question, the for Kambiz. And Sure. thanks

So the a back an to we a about. X-K notice referring patent 'XXX, that I application that June think issued the Therapeutics -- United received you're in noticeable late received patent of that application a allowance

issued not issuance. has today, they a As patent that of of received and notice have still not yet

long it That's that that a little bit issue. atypical patent take for for to

United what's on respect we -- at and visibility that So States to have we're not going Trademark the with Patent as Office don't patent. to

say it will that we'll ready to we're it preparing anticipating to However, we're be what and it. issue address I is will issue, for

Operator

Our comes Julian question BTIG. next from Harrison of

Julian Harrison

of related the patent some for guess, expires on on or year, the for any at asked PH-ILD approval YUTREPIA's United PH-ILD, United point? PAH FDA-designated full application notice progress. this have end March that next eligibility of to June. the received have approval assuming one I I Congrats back to exclusivity the to in PH-ILD in could last allowance a have full relevance you receive patent already patent in just after

Roger Jeffs

Yes.

speak regulatory So to the component. I'll

be of we Julian tentative approval, of would end So 'XX January have until that implication granted of in filed a at -- March the PDUFA in which be for XX, exclusivity time date, we PH-ILD, that because There amendment does market in of no terms expire would not July. getting terms and a 'XX.

don't patent regulatory speak we commercialization and about that? any the whatever want may that with process. you the gate approval Rusty, to So happen see post between

Russell Schundler

Sure.

for thank the question. Julian, So you

no So be new this stay clear, attaches to be would XX-month that there patent. to

convince of it way should would the is an able court to So us from prevent into would only if a injunction be Therapeutics get impact launching. and have potentially sort go some they that to judge an United

convince patent compares that launch the looking numerous a we patent filed, it it, in think if they should with they're have date that, the and at anticipate art. way But 'XXX prior that in done if patent, patent I this we is TYVASO the of medical that the able that would notwithstanding an the looking how new to the which As and only be of again, were court. impact court between Obviously, assert entitled prior a to last lot studies by to to said think we'll they call, we this they injunction. professionals all there's will, art, at was this deal

Operator

no am at further this showing time. I questions

it So to I turn would Jeffs. to Roger back like

Roger Jeffs

Thank you, Therese.

team the and ready because near most investors in YUTREPIA the about So depth wanted the call of hear intentionally I the we launching let that of the and are I to very team future. today quality excited have answer that the very

the and of can its quality thing other differentiate quickly The what choice, of first you the asked that prostacyclin hear is potential to YUTREPIA's product as become about. and profile Kambiz

we our bridge thank to on We you forward continuing you look you. for joining inflecting update as we us important to today, Thank progress and these to events.

Operator

This the does program. conclude

You disconnect. now may

Liquidia (LQDA) 7 Nov 232023 Q3 Earnings call transcript