LQDA - Earnings call transcript Q2 2024

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Operator

Good morning, and welcome, everyone, to the Liquidia Corporation Second Quarter 2024 Financial Results and Corporate Update Conference Call. My name is Lisa, and I will be your conference operator today. [Operator Instructions] I would now like to remind everyone this conference call is being recorded. I will now hand the call over to Jason Adair, Chief Business Officer. Please go ahead.

Jason Adair

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

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

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

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

Roger Jeffs

Thank Jason. today. Good joining Thank morning, for you, you us everyone.

to on and this. hypertension lung both anxiously still we FDA YUTREPIA achieving PH-ILD, we and await or for we disease, While seeking close NDA associated that approval pulmonary action are PAH, patients hypertension, interstitial arterial the pulmonary with hopeful remain

YUTREPIA will be remain upon active take specifics communication our X over say approval. for have our As and no on and crystal in the both these conversations alert, launch past with April immediately can PH-ILD. What teams impediments we not on to comment amendment action and that today the FDA. To I reminder, as a FDA FDA constructive of heightened we hit seeking to commercial with PAH has clear, the medical been ready the since is on X submitted approval legal months, the but

relationships upon specialty to are and accounts, call product to And on educating them key commercial team Liquidia. strengthening pharmacies importantly, we approval. PAH on distribution staging sales continues Our rapid for

open-label in screening of clinical the YUTREPIA to clinical patient parallel patients patient in enrollment. number The to programs. Moving up our continues ASCENT in increases of and active sites, ramp study with PH-ILD

preliminary We pleased suggesting to titrate physicians the therapeutic with these patients. can feedback levels that from are YUTREPIA patients in escalating PH-ILD readily

today data ASCENT the the benefits mature patients. While via to PRINT-formulated experience PAH in inhaler our suggests good treprostinil of experience more, parallels a patient early needs low-effort very delivered observed that

XXX.X the for ASCENT Tyvaso in doses session, to tolerability XX session, median micrograms potentially of exemplify of clinical orders YUTREPIA additional XXX target to XX paradigm-shifting patients trial ASCENT the to For is recommended per the PAH trial submit are breath XX beyond dose magnitude of of patients, the breath conferences. X several equivalents. example, and PH-ILD as These durability. We at data potential especially and of and YUTREPIA from dose X future it of relates micrograms plan or for treatment dose a top weeks Tyvaso the enrolled approximately approximately with per currently beyond or equivalents breath

our formulation treprostinil, switching patients more first that. With Tyvaso on exploratory preliminary inhaled encouraging. sustained-release Tyvaso LXXX, from So highly our to or come the XX data efficacy has liposomal to DPI respect from the clinical data and safety in study been of open-label

LXXX, Type inhaled dosing XX-hour with all helped Agency, of times trial with a the over which titratability of similar systemic favorable Cmax, from sevenfold and our very a solicit tolerability favorable our EMA, handheld observe the in was a pivotal this to profile C compared portable likely December. with long-term lower twice design, generated data the Medicines advice attributable breath European using from continue on last meeting but safety from actuated the a rapid treprostinil, consistent has or nebulizer. The month to while FDA's day of a scientific feedback We study daily period dosing X exposure

efforts continue trial now time, the patients this patients the we our will to will Mike registrational initiate results. While over financial to I observe these later to in the in our with study, PH-ILD open-label global quarter year. At to call to shift the this second turn summarize focus

Michael Kaseta

Thank our press you, financial briefly everyone. in I address quarter found today's Roger, and will good morning, release. second results

ended As the million compared in compensation, net a quarter a was to decrease was due YUTREPIA-related fees increased commercial to we $X.X administrative ongoing which agreement lower revenue compared Sandoz expenses, to million of to in million $X.X in with million quarter XXXX. for $X.X quarter sales Revenue primarily or ended second primarily million of current diluted see, million the in quarter LXXX X clinical expenses a share, same related as second year months of XXXX with diluted $XX.X development head X expenses, LXXX basic and quantities was increase and the $XX offset the months million XXXX, $XX.X personnel in in loss $X.X $X.X $X.XX to to million the Pharmosa legal same period XXXX. per XX, million the for increase year. Cost $X.XX to revenue The million XX, which We compared were million $XX.X June We license for tied million exclusive YUTREPIA March related XXXX. compared to our in increase decreases These second basic and increase of $XX.X or $X.X same of a inventory per to injection. and ended commercialize to increase you summary, in in million loss force driven increase million decrease the net to due share consulting year. With a was in in North of promotional primarily XXXX, and the objectives compared increase and $X.X $XXX our includes $X.X will corporate in XXXX second I'd The in XXXX, to quarter to a our to Roger. the year. for program in quarter in litigation. In upfront our during incurred $X.X compared treprostinil hand, in expenses like XXXX, increased for to XXXX, expenses program to over stock-based the fourth and prior the by of being financially with for of that, due license prelaunch the the related prior quarter this the million cash million related America. were saw $X.X million for achieve turn a same on call our well quarter were the costs remain with our by million to XQ sales a of quarter XXXX a expenses expansion expensing to expenses second $X.X fee included personnel XXXX. Research back with count. General to million $X.X and $XX the the positioned now the

Roger Jeffs

Mike. you, Thank

last you've heard, been As an active since just call. it's fronts summer several our on

YUTREPIA YUTREPIA potential We opportunity currently grow for a billion to potential a are to professionals launch market run market grow who in dedicated treprostinil the would to is a along that, Operator, dosing coming call can This of provide for years. YUTREPIA's inhaled now the the of please. are for like prepared excess team keen in I question advantages approved. With $X.X approval. The with with of fully alternative, upon potentially remains and with inhaled for open competitive and to the treprostinil especially the poised billion that once the at market questions. $X tolerability rate, reshape first

Operator

Harrison of from our Julian And comes question BTIG. today first Instructions] [Operator

Julian Harrison

Congrats be on the recent and we progress. if exposure could PH-ILD. both should beneficial in PAH I'm why review briefly treprostinil wondering inhaled higher

Roger Jeffs

Yes, for the Julian. Thanks much very question.

So and additional some add start then to Rajeev I'll I'll ask color.

have one that the particular prostacyclins beauties continually the is continues of without relent. prostacyclins over use advancing an that time, disease ability titrate what because, and to So historically of know -- we the these from unfortunately, effect to of is in patients

the the to and tweak, of prostacyclins. way only So therapeutic a progressive sort an remain that are address class ability can disease only this --

parenteral, look the to is as of a had But you titrate see to prior low various its therapy. hallmark a Tyvaso, above treprostinil is that at see the ability therapeutic titrate been if fairly inhaled, particular, in you YUTREPIA So in with the can to ceiling. inability forms, you limiting oral, what

So products, but oral is it's why shifting, this you the paradigm say parenteral site and to it the side done, giving YUTREPIA it's directly and I of giving the systemic has all to what effects. the limit action benefits of

to therapeutic also effect, side have you dosed So while that with can really a the minimizing effect. high now be highly utility flexible

and first-in-choice inhaled. Rajeev, profile terms So be so comments. marketplace it think brings additional this considering think excited it a I different to know starting the any utility will this oral we're have about of if it is or of YUTREPIA. we to I therapeutic use. best-in-class And treprostinil parenteral, both a lead become We in sort don't prostacyclin, think when why you

Rajeev Saggar

Yes. Julian, a it. yes, we in is answered of lot that INCREASE Roger learned from most add, Quickly, I the PH-ILD. would think just I of study sort

that in walked this especially The patients, is clinical you than at data clinicians the of patients degrees highlighted that for for they heterogeneous secondary armamentarium the continue the to think think, outcomes. Also, for also I Roger breaths, be disease, farther, PH-ILD, temper was to opportunity and disease the of observations had of achieve clear both a advantage as in patients it's doses, and severity. as PAH of that to outcomes and the higher as group match X in many with more think severity going highlighted, very well I to they a various down, progressive. that and is and and patients, patients. as study, least that a in great these titrate And get those improvements many -- I

Julian Harrison

And have address unanswered ASCENT I sense what the review a expect And from you if to good curious Great. data can you when we I if a questions with may. the that might that are key we maybe one was for plan trial. comprehensive trial? more, disclosure just

Roger Jeffs

Yes. you if comment Maybe, that. on could Rajeev,

Rajeev Saggar

Yes, Julian.

is year. exploratory been to then outcomes catheterization. and with and treated. XX actually follow PH-ILD and study just the the patients out So the tolerability, to The months, patients secondary have right efficacy we YUTREPIA is baseline with of be for again, X ASCENT have enroll studying The a the in study safety heart not everyone, who to patient remind would

what to after that of the durability. in maintain what So in patients is we're here INCREASE on know have of dose optimal looking do study also the amount significant to what Because very is a many the start that YUTREPIA, patients and to these weeks is is a we instability. XX of for -- show important study,

show definitely wanted we durability. So to have patients

set in clinical of some out highlight coming really, to really is that of focus this here, the next data. approaching congresses Our exploratory are efficacy

the patients said, on now, micrograms. compare to this now X/X looking is were just is, at And also really as those forms at highlight micrograms following the Roger that, by years, right use that and clinical highlight such on just also lung is looking effects using our walked to -- This by CT of X XXX.X YUTREPIA. of median least as we're terms sentinel PAH, are questionnaires. where X-minute in dose particularly patients chest various XXX the the vasculature, now vasculature We're highlight, effect with variables INSPIRE you is pulmonary for mark YUTREPIA. I want to in We on the were really the at imaging, the X-week lung of on patients distance of of walk. about study past if parenchyma to the finally,

the So YUTREPIA. the very we a seeing -- And think I by to to patients dose future. patient. what highlighting there's of that go and the is to we're providers clinical And are back clear providers just some here look dose, of in the the tolerate our question, to also, very these to benefit understanding higher parameters forward near potential able particular in last that

Roger Jeffs

Thanks, Rajeev.

'XX. And Julian, you it We're publish robust can trying hear, to we'll that as specifically study. by answer very your year-end, in to complete then So question. to look

Operator

question of Needham. will be And coming Belanger Serge our from next

Serge Belanger

I of legal ones. couple have a

dismissal, for on the I FDA. Liquidia motion in one, case and First the believe, completed agency both their briefs. against UT the

related you how time a that decision on case, the briefs. And visibility FDA this or we'll the So YUTREPIA rendering any this them motion? here, steps a factor is judge-based be to gating hearing have for following if the And on closely for next rule whether get could NDA? how curious a just lines on

Roger Jeffs

Serge. the Rusty? for Great, Thanks question.

Russell Schundler

thanks Serge, question. Yes, for the

your take -- first on So first. the question

yet to either steps. know way We have on On The the dismiss, yet. or it motion indication an oral court an could court. next don't don't have from the could argument the We rule briefs.

just there that. to guidance we're can't for really on So any because decide provide waiting the court

on And the for point, comment be comment his in communications second think in on the tough FDA's remarks, we opening FDA. Roger On obviously, think our the said to careful want to I to as I head. what's not it's us with

the comment on obviously, definitive taken action, obviously, FDA. once that. to our not with we will But So the going the meantime, in has FDA announce we're communications

Operator

Our next be question Jefferies. from Yazdi Kambiz will coming of

Kambiz Yazdi

study? can key you for far that you and start? patients onboarded maybe the registrational ASCENT how more features LXXX, And many is that remind study. For the then the when update? study us for the last slated points on finer since ASCENT have sites study so few design, have And a treated just the you to How many in

Roger Jeffs

your those both in are of court, please. Rajeev,

Rajeev Saggar

that interstitial LXXX, we of initiate patients with lung specifically Yes. by regarding the global year. pulmonary Kambiz, associated single so disease, with efficacy study to hypertension with study end plan the in the placebo-controlled

do working agencies. we're steps and submitted make that to all think protocols to our the are necessary viewed feverishly I appropriately sure by

As from scientific feedback the the Medicines advice had C from Type from Agency. European we've also with FDA Roger highlighted, the and both favorable the meeting

confident plans. We've X-minute important our secondary be highlighted study I think whole our endpoint walk distance, already with support going in the target think in be a profile. would we remain to I of that this So primary host endpoints efficacy to is pretty

treprostinil, I extremely open-label of with titratability the and really emerging think confident, safety support cost a study just to of a think technology States. the liposomal the dosing in United data Again, on twice from along reduced we're which be minimize day. drug, this the on think, I and really the highlighting top changer, based going to frequency is I a shown to game that's has

extremely very the the addition for about need, feedback outside showing remain regard. There's support throughout unmet of I we U.S. definitely significant the So study. U.S., of the amount has that KOLs that been to market the think, excited in in global

on we're close tripling of anticipate ASCENT, by the close year. of we of confident number month, terms patients -- the by this sites study of completing we and end to the this the end In have by about the to XX have to month. the end quite about We of remain

come sites remainder Just to well. the anticipate think come just on XX highlight the of sites been that that have the we'll we'll the have to be ramp majority of XX within by have recently past -- days, I rest of over next on the that the Then initiated we the as on and to time, study. full XX support days to

Roger Jeffs

for Thanks Rajeev. questions, Kambiz. you, Thank Great. the

an data easily seeing As Rajeev really LXXX now the obviously we're said. the to study that's to as quickly you in see both a think think from as I We're the excited the very patients, patients, I ASCENT and and differentiating, very format, get future. Same predictive as get day as the and see, fact with trial. market. we with will for on study positive are registrational we Phase titrate see that ASCENT the we the into think you can positive when flow the the to trial, LXXX something to ability of ability durability well as exciting And are, this open-label market to these program PH-ILD rapid as lean times a once X quite as dose that I III

Kambiz. question, the for thanks So

Operator

coming Kaplan of from be Thalmann. will Matt question next of Our the Ladenburg line

Matthew Kaplan

prevent past CRL? of which FDA would, I guess, approval approval, the kind guess, differences FDA FDA, your interaction necessitate I any with a guess material with since I identified and the we're has impediments for the legal would

Roger Jeffs

Matt, for question. Thanks it's Roger. the

we're discussions with in going really comment said not to specific the on intro, FDA. the I As

X is, work you time legal there's there at while are that. And in X, on months months solution. so this mirror, that, when look if that yes, no been a a spin to for the was we to put that's I past frustrating, way one rearview impediment being think is April to approval, I X want positive the X past to months think

closer had action. with focused we've that, that And on we're we with remain and think both decision discussions but much optimistic constructive a on won't that communications agency. And we for we approval to the comment an highly remain indications. So we direct

as amended, -- both as was and it we appropriate PAH seeking that's and So feel approval we we for PH-ILD. submitted are it,

position that away backed haven't our We from and remains that focus.

but that we'll I in we specifics, question. So with that can't and you. Operator, about have give hopefully apologies action an soon can great talk detail next

Operator

Gerberry Our the next America. of question Bank from line will be of Jason coming of

Jason Gerberry

me. for X So

in assumes the plans then roughly my submit scenario, could that are and preserve just runway? or to going if in as citizens' cash this second launch at Just alternative about, United's that any correspondence to flexibility behind talk if the there's if burn all. there any response. flexibility language cash most of that levers you of question Any delays, costs. runway. that any clarifying about around on assume approval handled the cash But curious assume Can a any submit I importer XX-Q, role an the on petition. the pull? And Is is scenes, there you year be LGM's to is to just I plans an -- any or

Roger Jeffs

Jason. Yes. Thanks, Great.

if cash Mike, could the you citizens' talk So and burn address petition, you'll question, please? the to if Rusty,

Michael Kaseta

Yes.

to of having initiated, We that. balance forward deliver. and also pride we're question. that this all position. still We thanks YUTREPIA. We've of mean year supporting now, of sit are we we cash. with of the a launch ability confident Jason, confident for I for million getting I strong think sitting objectives feel And our our where have we sheet. talked LXXX in in So We're of at with the the going very about $XXX ASCENT, taken with our very cash always rest

at make can on of objectives: trial. really of we those on that. do X able getting hand, being ASCENT is right getting continuing where depending deliver stand, now Now on be we'll things decisions, LXXX our to pivotal said, with launched, initiated, always and that we and will what's the trial focus But focus all to YUTREPIA

year-end burn you we cash at how look I our QX, always our from to when invest. we've think So in disciplined to balance, been QX

and YUTREPIA to in hopefully not-too-distant forward launch to continue here will future. a do We that the look

Russell Schundler

there communications do for Roger any Jason, comment a the will response petition. And won't the currently to FDA, be thanks as petition. on direct said we before, that filing public which, question Obviously, citizens' the and We anticipate -- on. citizens' the not between us issues

is, thing we United had to other public The I'd response, some misstatements petition we're file point out to cure even the that mean, again, not I have a won't at the at is anticipating time. citizens' But one public. amended or Therapeutics an original of petition, citizens' this on least

Operator

Thank does session. turn now closing like the for this you. I Roger today's ahead. conclude Please And Q&A over back remarks. would go to to call

Roger Jeffs

want I today. again, to Well, for everybody thank Great. us joining

you've profile As YUTREPIA updating future. look in the launched. PAH we near you. near We and once forward you clearly to Thank approvability competitive in term heard, in confident of and both PH-ILD the remain the the for

Operator

conference Thank call. today's you for joining

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Liquidia (LQDA) 7 Aug 242024 Q2 Earnings call transcript