Earnings call transcript Q4 2022

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Operator

Good morning, and welcome, everyone, to the Liquidia Corporation's Full Year 2022 Financial Results and Corporate Update Conference Call. My name is Chris, 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. I would like to remind everyone that this conference call is being recorded.

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

Jason Adair

It's XXXX corporate Thank Liquidia's Chris. my welcome to you, everyone full year conference financial update and results call. pleasure to

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

statements well forward-looking note that performance contain the including those will financial future today's forward-looking and unaudited, as call please regarding conference begin, and/or results, we as Before company's information, future statements, achievements.

known are subject to unknown statements any which expressed These uncertainties, different on may materially actual to future performance and or implied risks performance or call. or results and results from cause the be

our company's Commission, website. to XXth. risk factors, information, XX-K additional on be file For please its documents and Monday, Exchange with on of the the which Securities can company will our accessed March including a The discussion filed refer detailed

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

Roger Jeffs

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

an As [Indiscernible]. my back on joined as year at I look remain to have first Liquidia, humble I CEO XXXX, organization

in an patients. to [Technical to the transform a option for role, a to low-burden join My potential high-burden which is from Difficulty] related YUTREPIA therapy operational company the pharmaceutical universally to treatment option

and YUTREPIA's portability. resonated attributes key and loudly with YUTREPIA's me; usability four durability, YUTREPIA's Specifically, tolerability, YUTREPIA's titratability,

or patients These and of PH the prostacyclin and therapy therapy best-in-class either PH-ILD. choice YUTREPIA four my be with attributes to to potential has continue resonate with for the that support first belief inhaled

in [Technical to fastest continue the and we is participate Difficulty] agent of in cross YUTREPIA the potential open The commercial inhaled market. extension label that segment key now to what our significantly of growing mature data only

internal and in-house. The other entire of joining manufacture our Difficulty] the for substance strength to capability organization advance the [Technical YUTREPIA

hand. in and uptake with legal now made -- strategic already of our YUTREPIA that core In hires had success key tentative our Liquidia it commercial to concert labeling course, we XXXX, also didn't in hurt the strengthen of is XXXX, maximize in Of approval we and launch. to well-positioned capabilities

to like are why our and Rajeev about provide are ideally those the so to key CMO expand of one over best-in-class call hires, patients. Saggar, turn to XXXX Rajeev? positioned I'd we we profile why product for option YUTREPIA's the we believe now on a differentiated excited and unique

Rajeev Saggar

its engaged low-resistance and patients, YUTREPIA Roger inhaler the clinical months, to In good team has upcoming topics medical related you, such our product Thank as morning recent the our with device profile, plan. benefits about certain and everyone. for of powder community dry

lung, a [Technical the Today, patients deepest with this varying to deliver parts to lung point. goal function. of I wide in a designed range range of to was a specific Difficulty] doses and touch YUTREPIA the thought on briefly treprostinil with broad mind across of

particular problems To tens the successfully COPD print powder children of with simple of such achieve dry the [Indiscernible] used as this thousands adults with three [Technical behind device proven RSOO plus a by whole technology inhaler, and many analysis. Difficulty]

our YUTREPIA of the breaths microgram XX.X doses nebulized to is the delivered point that bioequivalent proved clinical dose nine expanding of PAH pulmonary a range, TYVASO. To or hypertension dose in first at arterial study of

achieved of titrated if TYVASO, ever doses a with importantly, nebulizer. this the level But conveniently rarely comparable XX more has to safely and been YUTREPIA breaths

[Technical enough Difficulty] to [Technical it -- keep is technology DPI point, Difficulty] further, robust second in for train the To a myriad advanced positioning ways. or And patients. of easy-to-use to demonstrated proved

are lung there YUTREPIA, interstitial restriction disease medical considerable associated PAH is effort patients proven or professionals with comped. obstructive In lung record fact, given use among to respiratory hypertension with the with device's for where diseases, track particularly pulmonary and interest impaired lung

efforts Put particles low a wide and deep -- of Difficulty] [Technical across device for inspiratory patients. simply, delivery a PAH print consistent range consistent providing uniform with delivery for lung range PH-ILD and

that To may further to to utilized inform PH-ILD. the [Technical closer be use on we YUTREPIA. year tolerability later understanding this will this open-label of titrate the the clinical We ability best would Difficulty] population. YUTREPIA of and how benefit data potential generate we YUTREPIA, of in study intent think launch in trial an as our I'm to move greatly patient

the on to Rusty? I'd over like for an to turn now Rusty the legal call update proceeding.

Rusty Schundler

Rajeev. you, Thank

the infringed parallel Trial that patent by a Patent either invalid and in and [Indiscernible] United not received the Liquidia. against in has all or three rulings court reminder, Board the through claims by proceedings the Therapeutics company Appeal proceedings partes company the the As inter before in review asserted are

seen Over YUTREPIA our progress the bring several in we months, litigation have last market. to further to

it the First, in United XXX the grounds the In were of un-patentable. found the request all we are decision with PTAB's pleased IPR. February decision, to in XXX which rehearing for reject the claims PTAB that the Therapeutics' clarified patent upon its

Therapeutics decision. the February United appeal is from the PTAB's file of XX decision now of an to date days Xnd

they UT that occur as late early could will, or publicly Assuming XXXX. quarter as of quarter first fourth which they arguments appeal, have stated oral an files XXXX project we would

after by within days a affirming court issues court We could will argument a after then few of or full is oral the rendered as months as that anticipate few decision oral issued. written the opinion argument summary if a a a be early

progress third quarter oral in occur the position we District in second sometime Briefing of of the are in appeal court now trial. in Court's is process which appeal has been the XXXX. scheduling to or the completed argument, expect and of the the that with we pleased [Indiscernible] in the Second,

a few XXX argument. written of we would expect the within the decision oral receive As to the IPR, with after appeal a of court months

not available PACER briefings For all through course, the all we of appeals, summarize our System. public here. the will arguments of are, these to But court's

quickly proceedings through and both will as opportunities we Lastly, there or proceed to appeal as accelerate may appeals the be one timeline possible. process opportunities to seek in the

that is the appeal Therapeutics to Finally, related Hatch-Waxman United XXX notable the not patent. did it decision

is So, that impediment no of to our patent longer launch an YUTREPIA.

to final would the Court we decision on the the decision having patent reversed firm a be affirmed approval appeal the appeal. patent XXX in District see XXX patent and XXX if is to respect the now Court's able with is dropped, Hatch-Waxman XXX District the appeal regarding decision is of the the patent or on litigation YUTREPIA the been either for With PTAB's regarding done

on short, YUTREPIA In we affirmed appeal, seek can of final decisions original immediately. the then approval if are

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

Mike Kaseta

and Rusty, good you, everyone. morning, Thank

I address on fund about comment whom for relationship the I a wanted year the for relationship of SVB, our briefly security results Before the years. to bank and with a XXXX, had two full we've

to in previously with January SVB disclosed, as Healthcare financing Partners. agreement all we the owed of As repaid Royalty back debt

also was We held which held which the maintained and XX% fund an have all in was a of and BlackRock remainder mutual operating cash equivalents at in cash SVB, of account.

our an out financial On SVB week, accredited cash to was transferred substantially Tuesday institution. this of of all

last to to effort in will capital We what evaluate management cash investment our similar an continue the occurred and policies events our to week. from protect in

you year full will in for prior ended found results, for the to December Turning today, press XXXX XXXX be issued the million release the with our year. $XX.X increased which $XX.X XXst, year to compared see can that revenue million financial

with XXXX, the year, under The received percentage XX% of our Sandoz in agreement from whereas profit achievement decrease split as profits was XX% for entire to sales a promotion split of predetermined the XX% cumulative result we percentage thresholds.

associated acquisition with costs million is of and the Revenue amortization the $X.X in agreement. promotion contract of net XXXX purchase

$X with full with Next, of as asset XXXX promotion cost of year. the for year associated revenue included prior force million for $X.X was compared agreement. XXXX million sales related full costs the the the of as amortization intangible year well a

of million and for compared Research XXXX full personnel, with the a decrease $XX.X X% $X.X or decrease due of primarily to the prior. compensation $XX.X in development was year in million $X.X consulting, and expenses in year The stock-based expenses. million million

million in modification of in by primarily preparation expense, $X.X increase $X.X to potential commercial, prior for a General expenses XX% recorded a due personnel year compensation compared of million the marketing, increase $XX.X in first full quarter million option The driven stock-based XXXX the or was for of YUTREPIA was $XX.X administrative million and to $X.X increase million the for the and year. XXXX. commercialization an charge of and in expenses

loss diluted XXst, XXXX. million $X.XX In $XX share incurred or loss net a net the of ended per $XX.X basic and basic year diluted summary, compared million or of we December share for have per to a $X.XX and

financing ended for strengthened million access our Turning capital XXXX revenue We up hand. tranches. to in the Healthcare in through of $XXX balance agreement further four January sheet, we on with with cash million our to Royalty to interest $XX.X

related remaining acquisition an million increase $XX debt netted The paying to first of of the The legal cash agreement $XX.X parties. of the asset; tranche are off mutual one, facility. two, pathway; SVB an approximate of three, clearance the and million in after internal tranches

would Roger. turn to back like over to I the call now

Roger Jeffs

prepared Thank with [Technical you, Difficulty] I it the Difficulty] Reflecting Mike. so year, [Technical on can XXX% could previous patients. say

to I Operator, questions. to At this time, like would open question? now first

Operator

Our [Operator first Gregory America. you. Thank Harrison will Instructions] question come Bank of of from

Your line is open.

Gregory Harrison

question. the taking for Thanks morning. good Hey,

feedback YUTREPIA As launch, to TYVASO differentiation the DPI to when closer regarding from the comes demand you YUTREPIA you it what or get between for are patients to and receiving and start market? physicians

Roger Jeffs

conversations Rajeev, other this At potentially can pass maybe Greg. PPIs then to some time, give from give on the space? various you own [Technical Difficulty] you've different had to on what with Hi, reflections Yes. like and KOLs I'd in your thoughts you that

Rajeev Saggar

for Thanks, the Thanks question. Greg.

important arterial TYVASO, YUTREPIA day incredible. XX the in First patients [Technical equivalent pulmonary think to thing that to which studied hypertension of up is enable been doses it's a I INSPIRE times to is very YUTREPIA four that, breadth, in database has successfully Difficulty]

I think our two, titratability. one, tolerability, our showcases, and that number

concern heads has an [Technical only [Technical but population pulmonary Difficulty] interstitial this injury, with hypertension they have but arterial to also not lung disease, the which where a pulmonary Difficulty] causes diseases associated up capacity. vascular interstitial with because hypertension vial Specifically, and

part, will better resistance in its patient's device to tolerable lung using. this believe the particular. is because device where a and suitable low for allow limitations the this in We that to the we're We of has of ability be function YUTREPIA shine believe

nebulizer that those feel the all used it that such that, end, To in have simplicity are in practitioners as at the of inhaler we to our of similarities has we INSPIRE powder the hearing who benefits -- the portability. course, has dry least device, that like it our have of registry,

dry very forward of will where with Greg, powder to YUTREPIA open-label of To KOLs profiles where has patient an the we this that for highlight. study point, One, not highest tolerability and study, this in the important this of as will we population experience. some have utility of official impact a these and in so inhaler study to alluded PH-ILD, that it's the move and there an we product really YUTREPIA community important, know this you in is believe PH-ILD, using specifically we been believe think, and that's we showcase we to

And population. in this then because such, we ability only showcase the higher should our to see doses in tolerability, that titratability tolerability, improved but not as of patient

So the we the look forward year. to by the of end initiating study

Roger Jeffs

very why much, of we're you of to please. about so it excited significant Great a YUTREPIA solidifies sort Rajeev. Thank question, answer of question. profile Operator, capture and the really market next our product share ability the

Operator

Thank you. One for our question. moment please next

from Yazdi Kambiz next of will come Our Jefferies. question

line open. is Your

Kambiz Yazdi

feedback any granularity what Can have study? of so DPIs to of causing a gating received team. in Thank then the on terms in kind provide PH-ILD? PH-ILD factors you you morning, And much. you starting -- potentially Good coughing on

Roger Jeffs

to morning, well. Kambiz. hear from you Great as Good

for of get studies, supply. committees, CROs ethics that's approved really, terms the protocol really study just engaged to CTM ability the to and just at starting gating In factors our

speak simplistic. working PH-ILD And fairly coming and let our that's Rajeev studies in I'll intention start to in that. that So question, terms We're on the it's then those now, quarters. of to

Rajeev Saggar

Kambiz. Thanks,

hearing we're several think doubt, the is I dry what of is, convenience powder things patients like one, without think I inhaler. a the

Difficulty] interstitial disease fact. a pulmonary that's lung -- patients hypertension Number two, [Technical these So associated with have patients that

Jason Adair

you I'm PH-ILD. this started Rajeev, you Chris, Adair. sure, you if out Hey, could when to explain hear. Jason cut not the is there

Rajeev Saggar

Can me you hear now?

Jason Adair

Yes.

Rajeev Saggar

Yes.

population of cost particular, to to we with the exposed a that that, limitations resistance in tend we higher -- because when general, there's inherent a this inhaler. to are number efficiency, PH-ILD, understand certain of have in with So in patients

dry -- if done is have the exposed improperly limitations and potentially they're cause certain powder patient to so it's to cough done when of additional types inhalers. can that And this

Roger Jeffs

you, Thank Rajeev. Okay.

hypertensions. that own next with So, the the question, I possible given positioned could Difficulty]. would patient to Operator, bit little our the please. think of product, and that only we're the But that [Technical -- the but rate with be profile patients a the in different importance -- because be titration next not that PH-ILD, tolerability, now of our well it test of in

Operator

next Thank question. moment you. One for our please

Serge will from Our next question come Belanger Needham. of

open. is line Your

Serge Belanger

Hi. one Good morning. guess, just question. I

last you've how a benefits inhaler I there. over think and that inhaler the and product what from DPI talk YUTREPIA some few highlighted Roger, quarters YUTREPIA you. inhaler resistance highlighted the is of and just low TYVASO Maybe how the benefits about the DPI? Thank differentiates a are

Roger Jeffs

uniquely to use of device. that Print how a that's product it's is team Yes, formulation-driven. kind with that you a ports. that leaves answer going fact benefit predicated question. of the on allows this answer to great But I be It's lot up Rajeev to the formulation that actually can And formulation the question. resistance I'll the again speak Rajeev combination of think our

Rajeev Saggar

question. Great,

already to think that overcome the own. And just our has -- particles is almost require most powder for already agglomeration. obviously perfection been technology. And The such is noted, that barriers. inhaler PRINT Roger drug have deep riding in sized, to does lung. resistance technology not the the what to low highlight device innovative The means a no particles what positively PRINT these I suitable that have for YUTREPIA its

already into -- reasons PRINT ideal and the this particles, the growing eventually range drug key one size a And that, into optimizing of bring shape experience probably what these the there's And by of enables the flow market YUTREPIA PH-ILD excitement more historic is rates. across of dry a the simplest to -- effectively, is broad patients. powder by

Roger Jeffs

Thank you, Rajeev.

have without which to and certain that then that we to technically entry think would again, please. resistance capacity So formulation the that, the market. platform, limitation I need into device, to be do it's reached ability the leading think, be is Operator, -- question, given take there to can agglomerate higher use the differentiated we next delivery

Operator

question. moment One you. next for Thank the

will Harrison BTIG. question of next Our come from Julian

Your open. line is

Julian Harrison

Hi. Thank treprostinil DPI for Good has the if my market in any opportunity taking you sotatercept on morning. I'm question. mind? bearing your wondering,

Roger Jeffs

question, Julian. Rajeev. tag I'll again, Great Yes. with And team

triple first, just mechanisms, [Technical new own fits, hypertension, Difficulty] think, new pulmonary is growing Difficulty] an with I new Difficulty] I [Technical time [Technical it's let's say, new think Difficulty], in exciting to So these around modalities. impressive. excitement there's [Technical generally on our And including

previous this has best they Difficulty] and this sotatercept come years period. steady I've is Difficulty] dose patients a patients. been I And see [Technical with would also the ever It's or be treatments. Difficulty] in test and testing patients, the what Difficulty] YUTREPIA was be the could prostacyclin happened those In wherever specifically. in it to to because now exciting XX-plus think other performed been methodologies field for in, the prostacyclin. were in therapy it [Technical held there's every combination titrated time benefit to never Difficulty] sotatercept as see out [Technical [Technical add-on treatment therapies, been [Technical this And I

add Difficulty] the can Difficulty] [Technical be a So [Technical it excitement, if to And inhaler option. that market approval. YUTREPIA. be changing Difficulty] know can [Technical of lot of be the will Difficulty] you We're that that, building opportunity only capture effect. I [Technical belief first changed a anything plenty that? given drug [Technical the be really think Difficulty] Rajeev, in Difficulty]. my likely We excited they're again, with to I other Difficulty] will process upon will for have share has to [Technical significant about don't the it’s titrated so obviously, another which choice but [Technical drug, still it think, of a We

Rajeev Saggar

one arterial just issues on add, disease, only key a also remember is focused Yes, where just also lung specifically of not the yet said interstitial but Roger it shown pulmonary here hypertension, hypertension with I'll Julian, has not excellently. pulmonary associated benefit. sotatercept

Thank And so [Technical or both have will of the all Difficulty] we're driven -- and entirety to [Technical Difficulty]. we'll important populations be you.

Roger Jeffs

Great Operator, please. Yes. next thank you. Julian, question, efforts.

Operator

next Thank our you. moment question. for One

Kaplan question Thalmann. will Ladenburg from next come Matt Our of

is open. line Your

Matt Kaplan

Thank you morning. and good

us could of you guess, the little PH-ILD Just for on on approval pathway I bit opportunity. tell the questions, a one, a couple PH-ILD? up following about

study, there? of improvement to a look with titratability? to due showcase planned what secondly, some efficacy opportunity potential going end open-label And then to And points the at there is are in the your an you're

Roger Jeffs

to Yes. hear. Good Thanks, Matt.

talk pathway. So I'll about

So seek the market as approval Having we've Difficulty] in FDA said we date. [Technical obviously, in additional for can't before, required expired we've exclusivity are with studies for confirmed the that, post approval writing patients. that no for said that market in PH-ILD

in we the for we when and of of tenant So a approval. are those that's [Technical and approval our path approval case depend will of little on PH-ILD. have some But approval if move maybe, bit speak arterial provided we gating resolution legal of how parameters hypertension that general, the the kind pulmonary there. to Rajeev, could for you full are And the Difficulty] get

Rajeev Saggar

first so, specifically Difficulty], be as of call, on [indiscernible] this discussed a we [Technical PH-ILD. will Matt, this in study just all,

regard, the that this focus patients Difficulty] of of [Technical disease. YUTREPIA one understand range heterogeneous of in the major to in Remember, the about population. is patient of different really with So is tolerability types

and particular that highlighting range in if response. there's So any population really out that with the population, experience best the broad stands see

and such can fashion. several typical capacity walk those importantly, This or six-minute will points more we including levels data exceed absolutely a data walk tolerable translate to we're improved a better response. to equivalent is know focusing if second to We be titratability. breadth that conditions The have taking that We to we going one, [Technical if; number those acquire, keep as into levels thing Difficulty] see certain in reach that want a can distance.

actual imaging various using ventricle in also using fibrosis only the We non-invasive again, Difficulty] itself, the [Technical Difficulty]. scoring changes parameters non-invasive [Technical can but right also not look on of effects, at

on protocol. as come to more the that So final

Roger Jeffs

Thank you, Rajeev.

Matt Kaplan

That's helpful. you. And Thank very then…

Roger Jeffs

moment. One

Operator

there would turn I like the conference there no Roger I for I to no And questions further see are now Jeffs and -- the to questions in are see remarks. queue. closing further back

Roger Jeffs

Maybe we Matt can in. back let

Jason Adair

Could Chris, ask it? let in him had can Hey, more one Matt back you so he question.

Operator

moment One please. problem. No

Matt Kaplan

you Can hear me?

Operator

Yes. Mr. able to you Kaplan, next are question. your now ask

Matt Kaplan

Yes. Great.

quick a question. Just

decisions, approval of with current the and terms Hatch-Waxman thoughts the for with litigation moving timing on associated your full PTAB the parts In now? the -- what's

Roger Jeffs

legal Yes. ask sees on for to the Rusty he -- the of I'll out? opine Great the question. timeline Maybe playing some situation how

Rusty Schundler

Sure.

Matt. question, the for thanks So

point; So appeal we different patents and really Hatch-Waxman appeal on have IPR two at this and the the the decision; both of the separate get the of to clear opportunities of time 'XXX lines.

first appeal the Hatch-Waxman of So the decision. is

As earlier, dates. third the argument is some or briefing court time will year. to this and once And take waiting I quarter a decision noted We reaffirmance now date set the some oral get we're complete, been second argument oral of come that as think in of a we in as quarter held, just could on after a or be few expect not. we oral or could whether on depending months argument it couple has days in quickly

in the if seek proceed that. so that XXX District XXX, decision XXX to Court's Patent overturned, is we immediately is the if decision District to upheld, the full would and after approval be decision, And able regarding Court the of the

quarter in and this the would that second, it put fourth year. So sometime third

we XXX same would for to play oral months or we expect or results held after have Alternatively, we Court and IPR then And some of thing of quickly quarter we afterwards. will first that or year, as Patent few year, likely out. decision as upheld, long being a get quarter upheld, this a oral the time the next XXX that to days as few decision wait argument in And half as being noted, is that again, could of argument next the as appeal the afterwards a in be that if District year. appeal decision fourth first

Roger Jeffs

Thank Very any. clear. question, Rusty. Operator, next there you, if are

Operator

I back Roger moment turn the Jeffs questions One to please. remarks. Thank the call will see this in time no for you. further at closing queue. And I

Roger Jeffs

the appreciate momentum. calling I product have to around news as everybody hope the to Great. our as legal of I differentiated some And trying and to YUTREPIA situation. the building We're positive patients we back we benefit excitement think, the really and related you capabilities it share and into very the And in the it excitement you introduced how firstly, on go build listening. way. hear of our in continue to marketplace a could we be uniquely around market, can

Thank and We again in us, thank on you, Bye-bye. continued you quarters. look we joining forward our for reporting progress to the everyone. coming

Operator

you for conference today's concludes This call. all participating. Thank

You may disconnect, have day. pleasant now a and

Liquidia (LQDA) 16 Mar 232022 Q4 Earnings call transcript