LQDA - Earnings call transcript Q4 2021

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Operator

Good morning and welcome everyone, to the Liquidia Corporation Full Year 2021 Financial Results and Corporate Update Conference Call. My name is Josh, and I’ll 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. Instructions]. [Operator to today’s like being call everyone, recorded. remind, would conference that is I hand to call Vice will the I now over Development Strategy. President, and Jason Corporate Senior Adair,

Jason Adair

today’s pleasure Thank It’s and to update. year to call business XXXX to a welcome results you, for discuss my everyone Josh. provide full our to

actual based materially to and Such expectations. statements these involve risks I’d Before that call current we like begin, differ will on today’s that results may stated expectations. cause uncertainties everyone from remind contain to forward-looking statements may

further Liquidia’s information on and at on please For the company’s or filings Exchange factors, risk www.sec.gov Liquidia’s see www.liquidia.com. Securities website at with the Commission

Schundler; today will Roger. would to Financial Chief Senior after Roger and turn Kaseta; like and the Officer, Roger remarks, which of he Rusty open to call over your President are Liquidia the management. other Officer, call now the members I Mike for Jeffs; Chief questions. call Vice for prepared Joining Counsel, our Executive General

Roger Jeffs

you launch you today. the morning Thank as to full with Liquidia, a core year better on the be was of a XXXX towards at company’s focus everyone. pleasure multiple for to year. major began optimizing Jason efforts included initiatives It’s to XXXX of speaking focus a YUTREPIA we good year end our and this accomplishments.

description safety labeling. Some with as highlights includes patients are in switching view use issues the We approval with as as firstly, identified. received labeling favorable no well YUTREPIA we naive from in it of November both of prostacyclin highly as new tentative Tyvaso patient

more of three three patients some for prostacyclin PAH portable, choice. titratable, using years this at changer positions of to durable represents and game of YUTREPIA therapeutic first times potential excited This Tyvaso’s that to YUTREPIA been approximately to dose. therapeutic a therapy are bring patients We the doses whom become have than profile for and

market. the use Secondly trepostinil injection the in April of into subcutaneous we expanded

of unique Approximately number approximately to with subcutaneous doubled XXXX. on April we patients based report. brand switched As XXX XXX patients have a today than patient therapy prescribers XXX approximately injection prescribers on of in including unique launch pharmacy result, our since the more generic from trepostinil specialty on

new continued being are payers see issued to demand from payers to from lives. growth of cover millions as expect generic large mandates We increasingly of tens

our written Thirdly, IPR final decision we significantly for found with claims also XXX that a nine have patent, litigation Therapeutics advanced in United the including of the the unpatentable. seven ongoing

be XXX that on summary instituted stipulation the judgment reason go also likelihood she non-infringement of for no to the that the will addition, the longer stating XXX is last for United the the are the And month. on PTAB invalidate obvious Hatch-Waxman of the in the the X same invalid be prevailing trial, is patent which patent before comment this XXX not Hall claims the before in that we was Therapeutics over Liquidia’s a XXX of to based important not would it Therapeutics the find assertion Delaware or did patent the validity demonstrated part note claims decision United that the Court and claims of XXX XXX of of was on previously the led patent. of asserted Level of noted not of Friday’s In IPR of that will PTAB that in that patents may likelihood patent, same the judgment based summary the prior Judge the issue as that specifically claims Liquidia as this issue court trial. end hoped, unpatentable of combination with while certain the And reasonable all its scheduled art. court

trial. credit in be balance our based and early are sheet if collateral and solely given funding you. of we XXX the fact, presented our milestones optimization Judge And in not key patents, the over that SBD arguments for XXX than we positions regarding Kaseta anything business only on was that finally confident non-infringement with refinancing detail you. of will will Mike invalidity the scope to recommendation stop and the facility through YUTREPIA to of technicalities initiatives arguments legal of through applies now strengthened at more Hall’s days In launch Mike, providing the before our and on describe of as substance our that in more

Mike Kaseta

Thank you Roger and morning good everyone.

RareGen summary development the force for $X.X for million compared in $XXX,XXX $XX.X the November of full with by XXXX as Trepostinil amortization promotion the was and $XXX,XXX year recording decrease was ongoing and The the basic and diluted expenses YUTREPIA promotion Our of in a the million $XX.X intangible force to year revenue of promotion loss to our decrease prior net full million market to related per for approximately employee upon XXXX year full million the million the the fees YUTREPIA Form The December year. today completed related costs the assets $X.X consulting of acquisition X.X costs or $X year lower based XXXX million lower full expenses to was share expenses. this press the filed associated to issued to sales in we've XXXX. of November. included in for of today. the XXXX costs the net $XX.X of see expenses year Revenue is last XXXX litigation of for a the relating year with YUTREPIA administrative related XXXX promotion or closes a incurred and acquisition basic approval of decreased compared due net and to with and million commercial million were the full diluted share compared prior compared increase release and year for $XX.X -- the XX.X under earlier and for agreement the clinical In contract full from loss results in in full to will a with compared XXXX XX% revenue XX% the of full ended Cost first, XXXX with General $X.XX year agreement. million In XXXX. of amortization following after year. and consulting was XX-K $X offset as the and document per revenue found stock $XX.X be million related our compensation tentative or which of be that recognized NDA year. The million prior to X.X our primarily on million XX, of Research was you of increase filing substantially increase personnel legal XXXX. decrease with agreement. million associated driven the year by $X.XX to can sales program in well financial of $XX.X for prior related SEC injection in a of

positioned our $XX increased provide Silicon ended position. $XX.X immediate million the balance combined a access an We like the also approval. strong additional In be million facility we certain With to final milestones. in to revenue Valley call on YUTREPIA XXXX debt pending I'd Trepostinil sheet When Turning now the year the of to company FDA the its back we Bank with ended from early capital hand. Roger. continued launch injection, our to that available on XXXX cash to with cash to well turn with pending of XXXX additional over will with

Roger Jeffs

Mike. you Thank

prospects the for about forward growth are the extremely we excited Moving company.

and As Jason mentioned joined and key it will Operator, leadership for open first I team question other by of Mike up we our are please. questions. now members

Operator

[Operator Instructions].

comes with Yazdi Kambiz Our first question from Jefferies.

may You your with proceed questions.

Kambiz Yazdi

questions me. and Chris here. Roger on Three Hey everyone. for Kambiz morning Good for team.

responded all, generics summary of judgment thank PAH inhaled And thirdly, Trepostinil? to it strategy these question, billion during think expand how there stands revealed the proceedings, United Second of you a have why do First the currently of availability -- any you? then the to today? during market subcutaneous from was can where YUTREPIA payers

Roger Jeffs

for the able think so. Thank you questions. and then at Mike least YUTREPIA question, answer it's generic do Kambiz strategy the the And answer growing he's we legal for why a and have market reply I'll first opportunity. about to opportunity one what the on

the is durability. tolerability, lever market value for four accelerators opportunity they there's lever by YUTREPIA portability, near other really is of term are multiple titratability, terms one driven lever lever the and and is in key final So is levers. One the

let So speak little bit. me to that a

around you greatly because the small a and look done sized if $XXX from million that's market, powder to estimated X breaths just think transition formulations. times rapidly formulation X estimate. just a session, it per formulation you're the value XX product of a portability market for be We of to day and think pocket about is market with YUTREPIA the like simply dry breaths dry is PAH to capsules So And four powder session the per it's quite taking I pack will delivery. with a booster that a two Group to device nebulized at

trials small example active using and more in a two number the million those. are devices have in also in that for So, asthma been in are PAH highly tried use These portable license the true used COPD we years. million these obviously need or of And to there's we $X small of companies same only example [indiscernible] of device. $X and for device

change will So portability the paradigm.

profile not of of it's formulation though Trepostinil think we've simply I therapeutic inhaled importantly using uniquely changed Trepostinil. PRINT the also More our portability

that monitors lower the does upper performance for as so range. less So uniform size you fly and lung, through the better deposition What particles the PRINT X.X in is in first particles the allow micron know airway. provides that aerodynamic shape

adverse So there lower what is deposition that throat. seen to have for in related we the potential is events

true So borne to looked studies at less cough. This early in out pain, the our dosing. has less be we when and irritation

in have expansion open term had we up patients So years. studies now to long three for

a session. breaths therapeutic excess Tyvaso, in times about in We patients the of day of three be equivalent so breaths XX what times four talking we're delivering have you're two would of per four to which dose

in massively that oral dosed really that is lead can behaving or the profile to change better be there Trepostinil parenteral starting capabilities to So would effect. like and then inhaled now What to is so different that more durability. its a

So, be on their inhaled hold physicians longer to Trepostinil. will patients able

more use and expansion market on the parenteral therapies into of you're greatly oral see these two probably to our choice the to going it to driven these onerous expand pharmacologic oral to we take choice. first the on prostacyclin greatly YUTREPIA a prostacyclin $XXX million Really and attributes to based just described. of today that which And again can issues. think drive to including durability going as first and campaign think it and as was tolerability use we delay both time is one I've earlier of as I market well is it's going So infringe have expand ways;

So, you talk generic Mike, the could question. about if

Mike Kaseta

absolutely. thanks Yes, Roger Thanks, and Kambiz.

for I payer think the from where us, took to they injectable before subcutaneous burden before perspective. critical It was had and subcutaneous. differentiate of a approval payers administrative off

You first which was we approximately as therapy, was said, double which had last April than in know, XXXX, -- before than more Roger subcutaneous XXX patients one have on we is the what the month which approval.

addition, several just large beyond have as of injection expect uptick approximately And patients. for into revenue XX fill and already has not to giving require and we're generic payers In we contributed XXXX. million just mandated give that the to but, covering use not an we going XXXX, idea, of looking QX and -- will payers coming to we're move lives see two forward to Trepostinil going generic doubling guidance that national

Roger Jeffs

And Thank you, you can, you learned what speak Rusty can legal about Great. Mike. we if strategy. if to

Rusty Schundler

thanks the and question. Roger, for Thanks, Sure.

on general its really your collateral be answer made estoppel, based issue separate which of differentiated non-infringement to trial. summary and arguments discrete own is that question, from at the that's invalidity So judgment the first sort will is

as read that to strategy. UT's too So it's hard much into

the of is was think support those. that the notable it's products of be and on as invalidated Therapeutics' that I didn't by core XXX the claimed We XXX made notable a by think scope arguments or reject addressed in of disagree the and unpatentable or XXX recommendation, product the claimed deemed judge patent to is the and arguments we issuing prior art. previously comparison her United judgment, Therapeutics and United their in with patents, the patents XXX summary over our what XXX

will that's outcome certainly but -- of think be determinative notable. So the we is trial, at not that what how

move presented strategy we what issue think because that's But much UT us I from trial. is So informative into as discrete again, for will be. hard the at that it's to forward issues will to trial, too read the be

Kambiz Yazdi

answers. your you much so thank Okay, for

Roger Jeffs

next Operator, you. question thank please. Okay,

Operator

Thank you.

Our next question comes & Needham Company. Belanger with from Serge

proceed You may with questions. your

Serge Belanger

for second for looks the the guide were first get that I cash I of pretty just some in the guess like morning. you will Can the questions talk key question, just and up then trial YUTREPIA? it one the the how front expect guess Mike. just mostly those And Hi, should in significantly on for Thanks. fourth a me. potential trying prelaunch outline runway IPR about legal or items Can these your for patent Roger. XXXX, and for decisions you as process as just of or went commercial good quarter, OPEX determine A well ramp-up SG&A to onetime clarification? stuff, some couple the activities we

Roger Jeffs

case start drive can soon all clear legal will for Serge, kind just marketing legal we measures Yes. barriers. unwarranted in to launch. any with remove we're can free the taking and to we're preparation, the ensure how them. that we as of questions. pull just and so prelaunch our we And I'll Thanks our Obviously, forward market, terms as will of

preparing IPR of process So General our is Counsel, Rusty, maybe you will decisions happen course to since the talk -- we about and talk that now you key over Rusty in launch. could could the this year. are

Rusty Schundler

Yes.

just a of the this at to key of dates. is Obviously, preview the So end month. some trial give

IPR XXth So written a We're then in the in And these far Closing XXX the the it's will XXst. then we quickly hard from IPR out. XXth busy. Wilmington, decision the in know scheduled March be much the We are a get Hatch-Waxman we for a mid-May. on District will be hearing in the the because should Court it in in the mid-August. end as hands IPR sometime final arguments XXX expecting the Delaware. And to as to -- courts likely judge's give decision in that prior it's sometime decision decision to of receive that, comes from the how trial, stay. are But anticipating XX-month we'll the the guidance really, beyond to as

Roger Jeffs

Thank Great. you, Rusty.

you maybe can Mike, So questions answer cash? around the

Mike Kaseta

for Thanks Serge. question, absolutely. Yes, the

a from good a So really we where feel are we position. with cash perspective, cash from

certain gives the are with expansion We said, capital, good SVB access us where We milestones. immediate million Roger with are really upon with access we -- the tranches as -- feel we $XX of which additional of to along facility, additional are.

pre-commercialization win forward moving We with to are activities. We're playing here.

of next in for in We stock and QX. as weeks. to SG&A increase for did up feel really One, in get ramp kind some YUTREPIA process costs couple very ramp it's through here really in QX, ramping question related the of did XXXX in capital QX have compensation your position are on couple were QX increase it us get -- the as for and with trial comfortable related we we by There We that factors. of of approval. onetime up, our driven and of XXXX. us can into a We of the launch to the legal ready getting up costs we of --

are really compensation. increased. why a were And explanations of those the to was onetime the costs increase SG&A So most stock related of

Serge Belanger

Okay, great. Thank you.

Roger Jeffs

next Operator question Serge. you please. Thank

Operator

Thank you.

Our Wedbush. comes next with Andreas question from Argyrides

You with your may proceed questions.

Andreas Argyrides

preparations, some pipeline And how and forward at you litigation broadly, then Thanks. the Yeah, can planning that? -- in about at my provide going time let's good us thinking expanding you how A do of that thanks around are expiry plan you many start more for questions. about happen? launch them the timing the here. the to some kind with, are you details just -- PRINT morning. point Also technology would you Can details hire, reps couple month taking to what launch of around if by and thinking the more risk? resolved the isn't And XX the stay, of from

Roger Jeffs

question. the for Thanks

launching about we'll maybe order. reverse answer have Andreas, can launch the about things. Rusty risk prep, in litigation So, a PRINT, talk question I'll and and them Mike take about answer at

Mooresville, PRINT, for we in RTP. Carolina the we've North the proud in-house that obviously, approval, GMP validated with the facility tentative platform. YUTREPIA of Very with API having had in So manufacturing now

expand we're of the PRINT. We the are looking to for YUTREPIA. building we're to launch In trying leverage that expertise particular, opportunities of

longer-acting would interest we're in business about are have So really could of be penetrate we half things you, those itself whether These about areas forms could avail Excited already discussions that what to but potentially we doing year about -- we're that would early. that PRINT until And we data what we're broader looking having to niche at it's we first get to feel We YUTREPIA. pulmonary market then other talk doing next-generation complementary a the won't of we to also of this opportunity, there. orphan have hypertension. through what potentially.

So that's of broadly kind at we're looking things. way the

opportunity If and ourselves successfully I exclusivity patients a plate for our of we enough another grow can expire WHO think XXXX, two we there's growth huge we enough ahead prepare in X which and that only years on there's market success in YUTREPIA. if March opportunity launched to Group is into. the data away, then

and when certainly then COPD United will. broader chance in we ILD obviously, Therapeutics have markets, is to penetrate obviously, Tyvaso the in those -- their studies populations successful So on of we and then additional

talk this Mike, if ahead further we opportunity to with but And important improve have, therapy more certainly what that, So delivery you with just lots launch prep? to patients. of about the could maybe,

Mike Kaseta

from flow part came that Head of of have an prep, small a that company, Commercial, transaction. RareGen of we commercial Yes, with absolutely. I Scott also that part out of strategic Roger, wonderful the acquisition, the thanks existing sales targeted bringing and want who Moomaw, infrastructure as in a transaction question. the Thanks, just providing cash aside to to for point Launch the positive force,

to So launch YUTREPIA. that springboards prepare of a for us really

to XXXX. timing, an give we recently preparing just share the confident we are feel so we're idea into are that full and compete sales force for will out and Sales, YUTREPIA a the medical win to size be scale-up team. our affairs that in able mode. Head professional to going preparing launch and a We've No, Liquidia. but you on not specifics here to will of of And And in get we force, YUTREPIA sales and hired we're have of we building success for nimble

to in prepared comes are excited ramp launch. appropriately towards and we're So as head what for we XXXX, we up

Roger Jeffs

Mike. Thank you. Great answer,

litigation and launch. Rusty, can maybe the address question you So

Rusty Schundler

Sure.

for thanks question. So the

be risk, we gotten by by decision by that that to of whether As a we that XX-month it And the the until would that launch formed at be that's stay, haven't will we points the be a will if to of that XXX by make end right we able decision the IPR. don't informed will It have formed time. be it data number now. just trial, won't

we'll into we those time, information But because that all in hand. account we at factors certainly don't can't provide So just to that have at take make decision. guidance a point different this

Roger Jeffs

you questions. Andreas, please. next for Operator, question thank

Operator

[Operator you. Thank Instructions].

comes question with BTIG. from Harrison next Our Julian

Julian Harrison

you questions. morning. taking Thank good for Hi, my

can you freedom requested YUTREPIA, that implemented gain confirm assuming a later for if the be this mitigation wondering year? Just risk to FDA operate strategy evaluation has not that you

Roger Jeffs

draft in would have APF one. have hand, not. no, The effective. the related an any answer we And formulation anything that's to that declared don't Yes, they the and cause therefore, safe easy been labeling we product's, obviously, concern. Again, is have

Julian Harrison

thanks much. very Excellent,

Operator

at to further would further showing not any you. I any over this call Thank now back Jeffs time. the for to remarks. I'm turn Roger like questions And

Roger Jeffs

for our greatly today. joining your interest year. forward Bye-bye. day. look a to to great and you, We throughout progress We you thank us everyone updating Thank the about Great. Liquidia continued want call Have appreciate the in on operator.

Operator

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

disconnect. now may You

Liquidia (LQDA) 17 Mar 222021 Q4 Earnings call transcript