Earnings call transcript Q1 2023

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning, and welcome, everyone, to the Liquidia Corporation First Quarter 2023 Financial Results and Corporate Update Conference Call. My name is Lisa, 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. remind this to being call like recorded. would everyone conference that is I

hand to ahead. call Vice will the I now over Development Strategy. President, and Jason Please go Corporate Senior Adair,

Jason Adair

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

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

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

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

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

Roger Jeffs

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

weeks X we said remains high. our As just ago, confidence

sheet is strong. Our balance

diagnosis medical to opportunity Our prostacyclin at continues patients. seems a to is overall created PH-ILD inhaled for It's given treatment expand value offering of in It YUTREPIA low and have investor both true of as the YUTREPIA, exposure PH-ILD this option accelerate the titratability inhaled legal the team the gain demand the finally formulation should PH-ILD. are success to by treating experience for because opportunity benefits treprostinil helpful of continues physicians increasing previously especially courts the it PAH our inhaled device. The increased patient large tolerability, of market and an untreated treprostinil clear with up communities to in that the adoption can the that and of dry to benefits catching to in powder be group. intriguing resistance and see and quickly better

the to look forward defining we patients later profile open-label we wait in study to intend launch opportunity the PH-ILD in this an we product beneficial to that While for YUTREPIA's year. initiate further product,

One of and this our legal are to feedback on offer is most real-time we the launch potential reasons the YUTREPIA. approval recent decided move of earnings up near quarter gating events the to that to

arguments Court over to hand the for Rusty, who oral Hatch-Waxman appeals. to Rusty? yesterday the was I'd in the Federal like call the Circuit just in

Rusty Schundler

Roger. Thank you,

reminder, a either active the party of As the if the the the path Court which of for and Therapeutics, could XXX Circuit, to company speaking, paper. in Liquidia's appeals the ongoing ruled the is FDA XXX Broadly to at patents proceedings relate of patent. YUTREPIA, open Appeals an United to two final separate by two approval appeal Federal patent, asserted

ruling questions asserted with And claims Court's all Liquidia. X Liquidia spent by is that appeal to the the with a Court's the the majority argument found of not was the Liquidia that Hatch-Waxman arguments the claims the is invalid presented valid appeal. conducted patent, addressing Liquidia's and infringed patent The District remaining in oral infringed August during Federal asserted related appeal X litigation. Yesterday, the and The proceeding proceeding, UTC based to XXX court's the the time found appealing arguments In which XXX first District last this appeal is on this from the only to were were of most couple advanced decision Court's spent Hatch-Waxman ongoing and the decision the XXX district in of district's the respect XXX with the minutes in XXX the which of District decision by of that to litigation. claim with decision patent patent, relates respect UTC's of patent. few on appealing to the the the judges are respect a Circuit

the receive in of the appeal, as a outcome we the the Although months. hope court to from it's premature decision next speculate to to few

A second April patent Therapeutics and arguments their the all claims anticipate currently the late year scheduled either conclude was this in rejected by initiated which the and its rehearing the briefing expect We XXXX. un-patentable. after fourth half first early will in ongoing PTAB this proceeding United in of request or oral the appeal appeal quarter in to the by were decision, that reaffirmed previous in XXX found of that be

of be briefing not a oral date summary of argument the as affirmants will few early then we Once could days the on appeal, are or decisions together, within written as argument be to after approval court taken appeals that oral are argued, clear court decision few after scheduled a then rendered we full of know all a is for the issues seek issued. by oral We if after the When months original arguments would will the the if is complete. final anticipate affirmed until these opinion YUTREPIA.

the to Mike for call on an Mike? pass overview financial reporting. now of I'll our

Michael Kaseta

and everyone. you, good Thank Rusty, morning,

to or foundation access combination a hand financing revenue From on [indiscernible]. funds financial can perspective, company and presence solid the build our never a we of the The which has future PAH through community. our provides in stronger from agreement been cash

get continues launch the commercial have We time, support light affairs our be operations initiated of At will medical to team green a commercial same our when inventory teams. and ramp YUTREPIA. recently production and to effort to hiring we the prepared

release results, was $X.X three to compared revenue the million to $X.X XXXX. quantities the injection the for related increase was quarter to in today, XXXX. was primarily be quarter, and profit found increased revenue can adjustments. issued was first the compared months to you for same will financial sale $X.X quarter to the Revenue net first press million XX, March under the the XXXX that gross million XXXX, see which in for Turning the treprostinil ended million our favorable to Sandoz, due which agreement of quarter and rebate split $X of same with Cost of of primarily

and $X.X XX% the quarter primarily a development million in YUTREPIA-related million, in of decrease expenses option million for quarter for driven potential commercial, stock-based expenses were of or in increase a for and modification increase of $X.X the of related quarter million January $X.X litigation extinguishment to were $X.X million ongoing million million and XXXX. to first to $X.X personnel XXXX compensation commercialization of a or of to a decrease decreases of SVB the the loss $X recorded over and totaled personnel $X.X quarter in year related the marketing million due an last our of and YUTREPIA. comparable expense expenses of in XX% loan General Research included commercialization offset with decrease with in repayment was in debt consulting increase due in preparation million was compared by XXXX, a The in $XX.X million fees expenses charge in legal million of YUTREPIA. the These increase Other same $X.X million the on for XXXX. $X.X in quarter potential by $X.X and to quarter primarily administrative were $X.X $X expenses first for compared million preparation XXXX. the an

quarter and million $X.XX quarter loss All net incurred loss per in XXXX. of basic first net per total, basic a compared million share of XXXX of $XX.X or of for or the we and first diluted diluted $XX.X share $X.XX a to the

execute quarter with the first the the sheet, and balance our on million year $XX.X totaling cash prepared ended to we well ahead. On cash for equivalents objectives and feel

like back I'd to to over turn now the call Roger.

Roger Jeffs

Thank Rusty. Mike. you, you, Thank

was admitted to want physicians admitted United in in red call Patients actual dose which they calculations. I about dose between a and DPI. care a made Therapeutics This earnings yesterday comment its hearing. Finally, briefly about received. They and calculations YUTREPIA don't only dose by the care is address Tyvaso that compared

about the in the DPI its of of also device, As low delivers doses robustness of the believe and Tyvaso approval, in beyond that be tentative providers. as registration YUTREPIA strongly level the our of that and treprostinil above the and patients are to studies comparable in validated as those granting and confirmed resistance their usability by doses FDA care ease and all comfort use we that to are well reliably our and precisely doses DPI will and Tyvaso their favored patients the treatment, Patients label. by and

call question, With for that, like I please. to turn would Operator, now questions. the over first

Operator

of first The comes Instructions] Harrison you. question Thank Bank of Greg from America. [Operator

Greg Harrison

this year I the year. said if that additional appeals would first any and of of you the it half color launch? different the impact YUTREPIA timing the scenarios respect could Maybe you just later how litigation the be give could know to of on next or with

proceedings looking judgment when continue should to get these what for So be we could best if happen. as that

Roger Jeffs

answering wouldn't that. you Rusty, if mind

Rusty Schundler

Sure.

remarks, I appeals noted as are to were which, ongoing our So allow my one favor, to in proceedings, either in would proceed decided if launch. of they X us there

and both calls, other that to on issue. on or as prior proceeding we are we said need at through successful first, ultimately one So be still appeal patents of the the

appeal both and in the the PTAB Hatch-Waxman either the in Hatch-Waxman XXX appeal prevail or to the the need we XXX ultimately, So appeal. in

Yes, that, the with scenarios. so scenarios, potential X potential there X really are And scenarios,

or lower The that affirmed. first lower be the would courts everything at tribunals is

the XXX time affirmed, the waiting is and mean is that decisions early get decision XXX next resolution PTAB guided or in which a If previously, would us sometime and current think is PTAB mean late to decision the would all affirmed, first will of in FDA we the final seek we've on our half affirmed. line, would that the year. against that in be clear then we approval. So the appeal, as as XXX we on sometimes be the as we is of Hatch-Waxman to what Based year decision would this favor for the our favor XXX affirmed are

Hatch-Waxman Second appeal, would the that patents. we scenario in prevail on be both

is reversed. to XXX court lower we patent go would on in So happen, the affirmed XXX seek approval. the final FDA If was has that lower prevail decision be where the where patent, to and we the clear immediately both court decision

so next months. said we that before, the anticipate as I And decision to X within X

we that reiterate, expire. market, scenario either those lower us or would all we again, wait previously, to But on scenario do again, I XXX would or XXX to the as year year. patents ultimately this final not have late first either that we've of would affirmed next we to for think prevail a courts where to clear the of to decisions if be The guided patent. if come And happens, want patent are half

Operator

from question of next will Belanger Serge coming Our be Needham.

Serge Belanger

from Just a couple questions me. of

for Rusty. one First

consistent to the straightforward pretty prior affirming decisions that was been you've most appeal. approval think on path I YUTREPIA the court

yesterday, if on the that outlook Court from most arguments So given Liquidia the just oral your has the curious, the D.C. on post time the of appeal. appeals of changed spent was

Rusty Schundler

So I think we be want to careful.

guiding not are decisions the the are as as speculating what judges or thinking to We to will what be.

as minutes sides had OXX appeal. to approximately think, the yesterday, know, of court the a XX on appeal. those XXX I Both oral of X only you X XX questions seconds total encountered from I yesterday, only related XX of arguments and

everyone we to think think speculate did. available don't listen thinking. to the as I are But I website we for factually, arguments So on I the are oral obviously, as certainly, judges said, to what anyone court's And saw those same thing want the else to.

Serge Belanger

for Okay. And Roger. one

dose products in the in past, you've DPI and other the the ranges YUTREPIA differentiation device. to the highlighted think I terms of of the

Just be to market. Is competing here? of how in important differentiation approach component your pricing this an could that much a

Roger Jeffs

We're to going pricing. not comment on

wait get we we think, what we'll communities, to and want satisfied make -- payer standpoint we'll with approval, then community, market, at and the go feel from I YUTREPIA approach all we our as but a preferred the that let's product, we is positional to to to position necessary on do when a market. to comment including obviously, least till

Operator

question next will of BTIG. from be The coming Julian Harrison

Julian Harrison

versus debate. high guess resistance on I the first low

most recent read patient preference. you your for wondering provide Just prescribed if on could

much manufacture all how with you at updates? then supply changed you at launch to recent risk? are preparations, And this And plan able about litigation regarding has ongoing to talk

Roger Jeffs

maybe And that. the and of advantages question So resistance for you launch in device, the preparedness that. could low terms Mike, I'll first of if ask to supply, answer the then answer about Rajeev

the on high. low Rajeev So first versus

Rajeev Saggar

already is drug have range PRINT. particles that that low-resistance again, range We [Technical repeatedly require inspiratory the including to more types, meaning particles on that the of just can believe suitable this highlight to the across not technology a lung, Difficulty]. zone allows technology, innovative the advantages any our Remember, PRINT powder most we of a designed powder enables Listen, work And patients for to the experience the again disease sized of a rates YUTREPIA the ILD. once discussed already low-resistance utilize flow we because PRINT cooperation leading use and deposit PH device with or ideal dry depth technology. in lung of devices with do

why is we're the excited this So about market. quite

Roger Jeffs

if Mike, inventory could and commercial comment on you build. stock

Michael Kaseta

In I overall think inventory supply, terms of launch about about preparation. the question all it's

last year, commercial launching at know, which included of there a gone XXXX, supply. when you was we through possibility of preparations, the had As end building launch

last year. We're continued currently supply. We've So efforts. we were building to those ready launch commercial

that's also or supply and other our be onboarding that. So force we confident medical I team. that launch, we are including building the add just that. doing and to We're whenever affairs in process, ready also starting will launch want sales to ongoing market very in preparations are clearance the to to out

So when ultimately launch launch. light, will the We we green this ready all is. are know be we go important we in outset. for be how ready will given And to

Roger Jeffs

to in We RTP. thing manufacture I I the want would Mike's One is substance to drug manufacturing comment in-house. our recognize team bulk add

we're it's control scalable of. in process a So that highly

feasible. our meet to ability market quite scale So and is demand

Operator

next Jefferies. our be And from of question Kambiz will Yazdi coming

Kambiz Yazdi

thinking PH-ILD are the do? What's second the And for restructuring to the kind does what then you question, open-label study, size allow the agreement you the GSK status of of of what that?

Roger Jeffs

GSK you ILD. Rajeev, question. answer the if label love about I'd talk of Jason, the the could you'll status open And

Rajeev Saggar

tolerability as the give bit the little Just such focused we this disease. near We of looking the understanding, of exploratory open-label lung endpoints, associated is interstitial believe pulmo end KOLs with and to ready patients launch utility, study. study year. with participate very on the an this evaluating in I that that. talking and this look launching a at said, the the to year for efficacy study as And be will and specifically getting which this end I is of so are we're forward sites once excited meantime, again, to with launch, actively we In KOLs, think should we in hypertension by

Roger Jeffs

talk the And the reversion if Jason, can you of GSK. about

Jason Adair

And the actions at last it's of one you if to years, think those has any in with that as a more to the shareholders. I company several look of for clear And been the areas each We potential started application it our GSK. address hurdle over technology. to creating respective taken the We've PRINT is our strategies became evolve, had could great that relationship that started XXXX. value help we other.

other on same are agreement So we in But for PRINT to when we of established, you we at That's over with including years, partnership is that can inhaled in we've technology I out in especially figure companies. And program advantage from what we meaning as GSK of this is has on is work think formulations. past, continued technology very a new them fit, which they clear look which see competitive say, assets a forward. moving as access PRINT have we had forward use last to about area. to can like, our using now been allows the have kind that them not the few inbound preclinical how lot restricted that applying doing development go any interest would to do that we what technology important

part GSK, very of parties where our So as in move forward licensing in to we're as can this both possible. value happy much with be creating new relationship

Operator

of Ladenburg. from coming will our And next Matt be question Kaplan

Matt Kaplan

manufacturing Just for minute. to go wanted a to back

constraints. at is and about launch a your size market the Can like are United of plans of given what PH-ILD be the little talk to address you potential One running seems the capacity into opportunity. your capacity the bit might that things

Roger Jeffs

Mike, out. answer maybe we're capacity build you around how earlier could and expand on to your looking

Michael Kaseta

We market. are very to excited this serve

a in-house have in-house very We we efficient where our do process manufacturing.

this this product we to We develop concern not I needs the in or meet great years and our like and have fully potential prepared prepared, ILD this We are every any one will fit desires demand to get do launch with said, discuss opportunity, be and and that we hand about patient's it that capacity. for demand ability larger to do several with for to we've been prepared be downstream partners and we constantly to that. working product have

So the the future. in forward comes, we through court as an we ready, and efficient term being manufacturing or and and be process, partners, launch whenever are are into be great able will we we when able that downstream the may that to to fully early serve fear confident look patients short do to it not have decision as

Roger Jeffs

Some points I'll add.

met API done. in well advance source the to which have capability We we've

API So we on hand. have

supply life Our are of most the long temperature. based at has The key chain with shelf is US. a X in years of product operations robust, room the

So again, once in And launched. whatever we Mike we as were the make launch last usefulness said, now fall. to will prepared have commercial supply

we bolus limiting I available. device a devices important, the inventory [indiscernible] in resistance but or the we standpoint, use is factor. will think of ever from for readily we And not the only a global which fraction, then a of a gating be this demand, of produced that sort millions So have of also order that low units device

very further we've can feel already, with scaled we and that comfortable we So scale ease.

position a of So I think strength. we're in

Matt Kaplan

for And after one process, Hatch-Waxman the be timing that? full the PTAB and launch I approval would then the just question, guess, second or you're what successful, assuming then of following completion the

Roger Jeffs

that the about that estimate the months. a will certainly moving the with into X may ask required. full to X we're and a going that we'll need from get if be Yes, of and to it's approval including target, little things safety on bit weeks we approval for a anywhere And do return updates to to process done, our of a communicate turning tenant FDA it but Matt, quick is

simple it's X X to Historically than good that, it's again, It So at from it. to look fairly when months. can precedents, weeks a but at look a think anywhere that's even way quicker I process. we be

Operator

questions you. any further Thank for over would not the time, call the At in closing to Roger turn And this showing remarks. I'm queue. to I like

Roger Jeffs

We us a and to and hopefully discuss Thank advancements have you, potential continuing case. day. broad everyone, going and forward legal its joining look talk about the morning. thank this YUTREPIA to in good for Well, you, forward

Operator

for everyone Thank today's This you joining conference conference. today's call. concludes

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

Liquidia (LQDA) 4 May 232023 Q1 Earnings call transcript