AQST - Earnings call transcript Q1 2022 | Aquestive Therapeutics, Inc.

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Operator

Good day and thank you for standing by. I would now like to introduce your host for today’s call, Bennett Watson.

You may begin.

Bennett Watson

Thank you, operator. Good morning and welcome to today’s call. business joined Chief Kendall, going followed Financial an of I’m and Executive to by call, in overview Toth, performance Ernie Officer, recent a today’s Q&A by quarter Chief Keith Officer provide the session. On first and XXXX, developments who are

the close a yesterday. As with the was that remarks Company’s release reminder, issued correspond today earnings after market

release conclusion on of its today’s non-GAAP of yesterday, Aquestive’s on posted Investors recording the call. be In of part call description to shortly will following made which of will section section addition, quarter you, the measures, the within website. website of review financial as earnings XXXX remind reconciliation results. found A available this the issued of first To be morning team the GAAP Investors a be measures is with along Aquestive this can some Aquestive’s discussing these the in

included remind Forward-Looking the X-K call, with filed other yesterday’s in with as the the During risks Commission as form well in outlined the in report in XX-K reports as annual the on filed quarterly our as section sections and March X, Harbor Form and current and the on earnings described We Company the reports Factors Risk in release on Exchange Company the be making company’s Safe affecting and language uncertainties And Securities Statements. our you on XXXX. Form XX-Q will of SEC.

the The the and and matters clarity. company cannot products uncertain commercialization with regulatory there or being related uncertainties pharmaceutical of development, pandemic highly other its respect candidates ongoing products to to approval commercialized, business and with is development significant with under of predicted operations. product company’s be and any certainty impact COVID-XX risks and and with are As

differ materially behalf the on not statements update date attributable entirety otherwise, conference applicable statements or the I place forward-looking new a or the All made. release from law. result on qualified may The under of statements you undue person statement expressly obligation only in as forward-looking these call, these to turn cautionary line its the to in earnings uncertainties, its information, Company issued the date future to acting which that, Actual after are whether no required Keith. this statements, assumes Given except contained and their as speak yesterday. statements. cautionary With will now results reliance of this over these Aquestive should forward-looking as events by any

Keith Kendall

And Bennett. recent you, will Thank thank and early the during remarks the you in Ernie I today, our discussing this May. call for of In our us developments through business and on first quarter everyone joining XXXX, morning. be

Aquestive will be remains and the Company and of Ernie on Part commenced EPIPHAST FDA. recently and fast we from X In mid-March, of for top X for Part As by I team always additional focused reported data epinephrine program. important keenly most study the during session study We drivers from the Libervant joined April. of positive designation for leadership the the crossover late value Q&A AQST-XXX Aquestive, to related AQST-XXX, that two members The afterward. the in line track AQST-XXX received

an of as housekeeping. million. for facility additional ongoing believe gives our equity to we fund and strong to of well us In as up That some additionally, in And regarding we continue XXXX. entered We flexibility core a funds, new April first is for source FDA our We with Libervant. of engage options review this operations. $XX good ongoing XXXX, quarter as the the into the remains business

Libervant. with regarding orphan the the Libervant, FDA drug NDA continues review the of with start Aquestive for Let's interact to

for also office agency a the and previously. received an estimate major AQST-XXX. we seeking recall, PDUFA has of provide issue, respect the an agency the that orphan contribution believe ready pre to product off to based evidenced not the you date a on action are have unable can and issues nasal agency would of care transform radar. of on epilepsy market belief of clinical that that is that product it products. to in compelling agency's product expected for lives FDA drug epinephrine. arguments clusters. We this the launch for that drug continue we providing of the from safety April top indicating development made FDA at that to we, Aquestive of With We the Libervant working if “Although exclusivity all of agency clinically focused FDA to in date represents development, orphan market timeframe”. that respect to an The precise product raised to fallen actively in that your With granted of granting agency's the the are a The OOPD advancing Libervant case remains the XX, by the patient such mind point to quote not Libervant discussed if in non-invasive believe to remain of exclusivity communicated the the you approvable diligently was and previous patients December As of granted our the This superior time. a received access by and we patients prepared we in efforts epilepsy the stakeholders I provides The have that assures potential reasonable guideline. the XXXX. for correspondence to we by making answer the be we a NDA. related requirements, your the a innovative as response. of access timing considering company the that a orphan rectal labeling to act the issues from is as as with cannot management to FDA. completion refractory to the notification XXXX these relevant a notice each is market product In Libervant efficacy respond the agency given access, important communications. outlined commit and on seizure continues coordinate is in agency

for reactions, product based including candidate epinephrine severe anaphylaxis. allergic Our

a population having it emergency such significant reminder, standards allergic are AQST-XXX for results current is Auvi-Q orally As reaction. demonstrate that needle clearance phobia, candidate the only EpiPen epinephrine administration, based of With of including first product convenience, injectors, represents lives. such and need and care not severe in where this medicine this patient part they the they to of the treatment February, of to or a auto a delivered clinical comparable incorrect when as IND delayed variety this patients need for Aquestive's improvement allowing of the the AQST-XXX in States. provided for development it caregivers meaning United FDA In and a reasons, group

a XXX previously confirmed reminder, As the bX agency path approval regulatory the AQST-XXX. appropriate for

the in the designation to fill received XXX. to to medical three and highlight an the we with the complete FDA pre the guidance is study serious of to Additionally, XXXX IND We track from in in track unmet line and part FDA conditions FDA want needs. one are plan conducting seek our study additional that the potential facilitate EPIPHAST treat designed March correspondence. fast granted therapies development process Fast review expedite that to of and

the two set showed anticipated robust April, product evaluating II In part Phase through later candidates We year. EPIPHAST AQST-XXX. study two in subjects to are master we seeking data and epinephrine subjects. this of of conversion drug a Tmax the earlier confirmed early for or end completed a of The meeting concentration healthy maximum with minutes. in pro Part of larger absorption XX results rapid to time immediate population of

threshold consistent on third results to XX demonstrate plan X Curve interactions per in absorption IND minutes have were XAUC reach The quarter end effects and further of the The of pharmacodynamics Under eight FDA this for pivotal the variety our FDA, and The anticipate end IM of delivery the to onset the be minutes been of package, excited submission. shown data commence additional EPIPHAST of the and clinically safety. speed which completing has again and absorption pharmacokinetics, second minutes, data for of kind. minutes that study minutes EPIPHAST and year. for X of its We Part The of or this We We study, study of our relevant under time the plan to written study Phase and XXXX. We continue April, film in suggested a under conversion to X Part AQST-XXX compare FDA We guidance is for XXX the purpose II epinephrine is conditions both the to of XX data a to EpiPen with designed that then that to We to study administration the the Based median commenced of a manual XX received later the Area this as the package the before from X.X year. quarter XXXX. a of end rescue injection. by meeting pharmacokinetic U.S. study are from to and the to AQST-XXX EPIPHAST key. the expect response we our the pg/mL, Aquestive the study injection. XX XXX plan XXXX. in study periods this and for was we milligram the comparable into Part showing to data is of EpiPen, necessary hemodynamic EPIPHAST IM of include the product study pre-IMD characterize the the with plan within comparative conduct the our from from data top-line we to to report during incorporate

quarter, continued as our cash. as the well contribute Additionally, to during business new core opportunities,

launch. propitiatory contribute Our Suboxone than through are we products. and to XXXX, will cash as contribute to and to SYMPAZAN has continues second approval continue we in revenue and grown our higher advancing quarter focused straight remains beyond. its since now at continue progress the resilient quarters, a perform These XXXX In and summary, expected. and on business XX level XX

for in pre the impact We FDA I and evaluate our that contact orphan repeatedly regarding the of as application remain said safety by discussed earlier. it in continuing approval of as Libervant that product The correspondence. completion Libervant. FDA efficacy, believe will requirements drug notice for the to will and with We is evidenced the exclusivity,

if are reported is EPIPHAST U.S. results positive we We immediately launch study, market X. Part X of Part prepared from advanced the XXX access. granted after to into

expect continues ongoing to forward our look capital forward strong specifics XXXX. would are continuing to to two year. update the perform pivotal look our II And our the Ernie Ernie all and in who We which in the And We that, over agency you an in trials with of of second to half commence will the end discuss these line to access on advance we we turn financial provides business performance, before and planning the to will throughout and outlined delivering end the Phase well, of initiatives meeting Ernie. results release, a outlook. strategy minute. as to I with like

Ernie Toth

Thank last evening. will good XX-Q seen you, financial and our By morning, that and now earnings in have you filed everyone. results release Keith our were

do, existing cash. will most from contribution business the strong the quarter Overall, of we our typically we the to of first As in we results continued saw of discussion address continued Q&A. and XXXX related performance

first expectations for quarter increase While our This significant a our Suboxone revenue. product outlook. is near-term it product the revenue a XX% part remains year-over-year in of a well performed and with exceeded us, in legacy

quarterly As Keith growth straight for revenue generated sequential SYMPAZAN XX previously, quarters. mentioned

compare debt Our Park growth Lincoln very repeat together Lincoln rest which XXXX. the term month its limitations year. Fund, Aquestive of entered the into up of with from that a terms but period XXXX and the the our business the our available represented XX gain our $XX our are common and the the access, business, first under provides market ATM XX% agreement, This the management tools funds XX, be facility, with purchase Park million and existing provide along activities, fund and to of anticipate agreement ongoing Libervant subjects for in same to the of upon the the the last April for strong purchase in as and well SYMPAZAN purchase time-to-time with On SYMPAZAN we over obligation company agreement. to should increase solid wholesaler retail has our and quarter right, to with a new conditions growth as Capital flexibility additional of capital expense ongoing not and as the under approved trends important the shipments sell you stock continued tools facility as prescribers on activities. when We pharmacies, company

These U.S. streams in our under launched royalty expect KemPharm, the future launch include licensed of we in recent EXSERVAN XXXX the U.S. Brazil the and to royalty as markets in to agreements ondansetron from as contribute forward, AZSTARYS, Corium Hypera their with revenue. Mitsubishi in approval. was outside in well streams license which EU from following with the Indivior, with by Tanabe, Looking Zambon, Suboxone by

contributing represent the potential these to cash royalties. of we to for also revenue and addition monetize royalties In opportunities company, to the as assets streams did KYNMOBI

results continue night projected other As reconfirmed accelerate during is manufacturing the in AQST-XXX our financial ongoing market of after continued outlined and activities we expected performance supply XXXX. last full-year of during outlook. we our business are press development SYMPAZAN strong R&D as on the release closed, to to issued operations, XXXX. our Spending and provide XXXX growth,

will of As additional from full-year adjusted $XX revenue At gross is to projected revenue to revenues U.S. loss and offset will the questions. to to any are and not accesses the cost as related reflects summary, as Libervant, include open approximately the that, $XX a to partially worth financial from $XX capital lower across Non-GAAP focused by EBITDA efficient be growth the will same R&D underway. I manage million as guidance advancement XXXX, line to market guidance of XXXX AQST-XXX. to as possible. of adjusted line reiterating the does we that full-year In up time, prudently this certain million. XX%. EBITDA expectations our launches for business and compared to back Sympazan Non-GAAP turn million continue is loss our approximately With for million. our Total investment operator XXXX a not significant It our steady base now follows. XX% approximately non-GAAP financial margin to reminder, $XX the until Suboxone and adjusted

Operator

Thank you. And our from Gary BMO first Instructions] Nachman Markets. [Operator comes question from Capital

open. now You is line

Unidentified Analyst

Gary And to a follows groups group? it for considered with if including discussions are after then on is drug more Libervant active timing Hey is the and what [indiscernible] are depending And me, I this Nachman. of on have other for committed you there approval recently any? FDA, for questions Couple orphan any launching Libervant, for options different few being still that?

Keith Kendall

for FDA, thanks step you question. and the in as take, I morning the word-for-word we them. we with letters We good well remain Sure, of know, think the get contact unusual sharing the actual

in communicating sees an how way, agency everybody the So us. unvarnished with is

spoken We have to of commissioner. the the office

We Cedar. to have head the of spoken

to head spoken of have We OOPD. the

And office in spoken active them clarity We be office. with try But all some group, answer continue and to Ombuds the of mind it within recently the their that the to working They it. commissioner's read whatever top we the the will reasonable there get and in us project know from from on a of to levels we with have it continue orphan get in is communicate that to most the they are FDA, Cedar we of as them. means. drug person to of period time, is will it to the just and they you is

we progress same language of of We clarify legislative to shake the also to orphan continue law. continue the changes that in the has which that it loose. the to monitor believe statute, try will the we drug around At time, some to PDUFA will and refresh

us, monitor understand Orphan are the to understand the try we not as drug related that exclusivity. but what is agency sure unless will to thinking or are we about agency if tells So those well

to maximum are have realize we extract we responsibility fiduciary to prepared question, our obviously launch, of your of the value part for amount a second assets. or The

So value if it certainly that. opposed there of is launching as considerate will extract a we to better way be to directly,

Unidentified Analyst

show study are and there? on be size filing? that hoping first you Great you would the could and still the had I to of the and what final of EPIPHAST the you for another of for half AQST-XXX, PK what was and sufficient with are study then Is pivotal planning in terms question especially And Thanks. three that formulation XXXX review part in dose. expected

Keith Kendall

questions great to the of XX Well, two, stuffing job but that you give opportunity answer Barber do for you. I Dan into a will

Daniel Barber

Good Sure. morning.

So, good and the we yes very feel about out. size dose, the final formulation that we are we from where recently X data put Part

we a So around in the as few believe Keith out Cmax, based release, walked Part that you we hit we through PD on the saw key ago, weeks marks X and formulation the we put and as data Tmax, have. so had you on with press

So envision formulation changes point to we don't or additional this the dose. we size don't see, or at

remain that same. the So, will

we is terms end anticipation in of of In said fall. in really before, the of Part additional X, our products as the of II Phase meeting that characterization

that? what we know to see. would that so, by And do We things the I mean like FDA will do

you one just answered data So, want parts and the So a of move your it this to to study happens dosing first than in question. happens having meeting. peanut film film swallow out for question, tongue. put under that plan, What about the where with a point agrees make summertime, out mentioned expect if I our we your Keith of administration really we a take also us which versus end what nice sandwich? are would of If data will different that I PK that in that set provide in the in happens is when you under read rather EpiPen, would through have. all with FDA I at thing before after out II sure the is do of Phase your time, would rounding pivotal with parameters? XXXX. Phase One you we forward the will What end half as butter of the II study CROSSOVER the data already a is walked is meeting we in we

Unidentified Analyst

Yep. That was Thanks. helpful. really

Operator

Thank next question comes you. JMP Securities. from our Jason And from Butler

now is line open. Your

Jason Butler

on Hi. progress. Thanks the Congrats questions. the taking for

couple follow-ups Just a XXX. on

crossover of thoughts the design look for was trial any I informing you from information EPIPHAST could in size a a than a the you whether goals assumptions comparator the use you what versus think X, comparator. question IM now as have and what head-to-head if versus, other Part here that difference updated one information the Thanks. have sample Do powering any pivotal, for on a versus study? And like arm, just looking pivotal on gain of epinephrine, differences you then trial the second or to the are this obvious study? potential

Daniel Barber

Thanks, and part we the And question what the Part did being between now pivotal need study the Yes, XX of we study, PK the Jason. X. the a right somewhere terms your XXX would for from PK we of so first in powering get volunteers. pivotal envision of

So done at what or in for or molecule, some [indiscernible] have like, injectable with so if others a the on. Auvi-Q pretty standard this look other you products

good is to additional have. the an does work. we So, EPIPHAST that to a element that study that And the than fill summertime point it we the because to we have there our design II on end-of-Phase feel will use that is And do and where additional information it your out part, design. different we about are the we in will

a will subjects. versus injection. of dosing product, X.X - do EpiPen and the IM also will be will repeat repeat XX the we will we be our do of dosing film, It a So it crossover, but

will FDA repeat compare data, So get will that we be out they is requirement that wants to two two the know of the to see. that are and will EpiPen, study. things a the dosing which be One really

Jason Butler

point? to a is several the this but if get missed just and or great. or helpful. a any Okay, on in Has work since Libervant, then, weeks meeting at sorry I last back And asked this do the FDA their clarification Really you to of for case new information, you point. them just the needing April it

Keith Kendall

they excuse they definition heard will have and in is for to a think, the focused talked have to repeatedly last reasonable time, every letter, they work there it, it, And in from get since is us have December, Yes. they Jason, of them it are I top they are is require is on communication since, no working their me, that the do them. we they additional use. and that that information said the you as language whatever to in mind, they us on that time

Jason Butler

thanks for taking Okay, Thanks Keith. the questions.

Keith Kendall

Yes.

Operator

question next Lake comes Flaten Thank you. And from Thomas our from Street.

now is line open. Your

Thomas Flaten

taking for questions to Thanks ground XXX. Great. out just the

and of XXXX, for be, would So a the readout timing XXXX, half assuming second something late first pivotal in submission kind data the study what that? success in the half early like to of of year FDA

Daniel Barber

pivotal see PK a as will half of small now. to agrees our in our Dan a we of Thomas, again. we the the of this study. in is doing, both - study would - of with out end them study right the the XXXX, first that to FDA there that at - come do be there one it two of things that things happening those see we us and goal meeting a would lead the pivotal is is the Both II end XXXX, second would Yes, PK we Yes, continued be in filing of study. of And parallel of if doing plan pediatric our Phase meeting out would

Thomas Flaten

manner And back they from Great. to learn you - what are FDA's or with timing have in precedents a acted can in you how or respect where Libervant? have similar the done found to there like they to with have then past Libervant, that? outcomes, any anything situations the done precedent what's Anything

Daniel Barber

have try FDA to There not, in past of The - other related a company date, action. didn't some did ultimately time. There know whether court us or or where the to a not give orphan they follow-up the situation force act FDA drug companies on to that those but I don't companies not we to now. were in is another been is similar right went

a many exclusivity and of I'm with in is precedents, is caught and And drug not understand to are think I and FDA trying FDA cases, they up we So what that. couple there sure are issue, following think that exactly court authority I have. think I ability protect think I orphan the the the ensure

Thomas Flaten

then updates, anything And it. AQST-XXX? one final just to Got here any one, on

Keith Kendall

Yes.

have believe we So are to with and that of additional want identify do XXX we though, work we make remain be. there indications excited this and we XXX created about At some right the that have sure and place. indications done what those Libervant could time we profile to get to the

us you as along. XXX will get with So on those two see coming continue assets behind to up two those farther they focus

Thomas Flaten

you Great. Thank I appreciate taking you. the question.

Operator

Thank you. Andreas Wedbush next Argyrides from And our Securities. question from comes

open. is line Your now

Andreas Argyrides

for morning taking Two and us on questions. thanks Good XXX. here for our

can Cmax were to zero EPIPHAST - XX X.X XX how mean help also better interpret in geometric that and the zero differences arithmetic value, we us values the epinephrine? And to zero greater the the compared then values but you. you AUC lower the to Thank interpret in the should minute First, XX to and study? AUC

Keith Kendall

Good morning Andreas.

So, I best will delving the statistician the on do first world. without one into my

you geometric and means. arithmetic geometric between main the literally would are the as systems mean calculated, I'm arithmetic the difference sure So how be right. One is very aware is, they average and of are

and better due better this indication mean giving variability. in would a between geometric in a the and gives geometric be seen what So, you as to arithmetic number like would is geometric you difference indication. largely look a of larger your a case Traditionally population,

larger variability, We know has high continuing with and an epinephrine molecule. variability know do on to this we level we studies focus we So going that as are forward. inherent of

minutes, feel second around a are and those you all XXX%, are of what good I out which is The below XX while at to. question three XX XX we the we minutes, about think XX, AUCs at really referring

XXX kind are would window. the think typically within broadly you as a of We that of comparable window XX to

So in What XX XXX. mid at we I even the we are above XX the eighties. minute like marks, think are and the to more we is low

significant that what or something we I like for shows IM at, improvement And is XX. are the XXX we that for So versus or providing. a a think potential think significant the improvement

happy XX are data. and really we minute So XX the XX, with

Andreas Argyrides

Okay. you That is it guys. me. Thank for

Operator

And [Operator comes Waingright. HC from question our next Instructions] you. Ram Thank from Selvaraju

now Your line is open.

Raghuram Selvaraju

Thanks if of for of seek possible just to the you color on With applicable likely in very taking provide assessment if to could I route respect that with special with the a respect on you protocol questions. XXX, would us may my if commercialization wondering discussions? any Phase a way any to firstly, for optimization context you FDA, much states. be in the was comment United take that of the value example, you end secondly, could of or outside II initiatives of And XXX is

Daniel Barber

to first is This colleague, Ram. will Dan. over it my I the is us. Sure, Ken I will then take and hand who here with

for We have thought about necessary this using as the spa process, but it we don't program. see

especially, fast with it necessary with of the is fast are our action. Phase running studies be track good to will getting from types availability know, have the understanding, like the end one meeting, and we don't But think, the that take the designation, FDA. of of things response II you benefits and that agreement that we As with we

are our request have study very on briefing in we designs traditional book II meeting, a So, planning a book Phase study. questions put and in, the end a in of ask that briefing our

So, to part. over Ken for the I will pass commercial it

Keith Kendall

is Ken. Hi, Ram. It Okay.

outside value not the optimizing inside was U.S. question of U.S. Your the

Raghuram Selvaraju

XXX That yes. is Yes, exactly right. for

Keith Kendall

value in Company's or is our get intent product its this time bit stage is outside to this at in - a anything the as this would own. we United a where know, this States little Keith. until the on have no at like along, wait life commercialize point you Ram, greater. little further Typically a we well, Typically,

us of that products is United some we I with approved is start looking how and have the at to the do think done other we for would partners this the time outside licensed. have we States that

think time get that II to Phase the do the we I of with discussion is agency. end after through the

to interested clarity full, will demonstrate people to outside in States is And the efforts United of to look them would We outside good get start thinking we the and around data time partner That pivotal the our about could that the product. States robust a study like. the we in have United find regions. what start the various set

Raghuram Selvaraju

ways Okay. If territories? And hypothetical does whatever optimize not path to the Libervant are there a in regulatory reason Libervant, just moment, approval for in engaging a to ex-U.S. its then with have in value any the respect U.S. here. to

Keith Kendall

Yes.

I the think great going Look, to is Libervant a market that question. Libervant and is is get a to of at end XXXX. great product the

the that parts it can. Outside as what to the hard with place the continue a a in to where interested at product. to much in attractive will Libervant were believe we the Libervant is gone with that gets it to product obviously are. has the of we going are through there. compete we really as other regulatory the based the products market, Libervant, regulatory with be are And with sooner, work get competitively, is where to we believe level great is possibly at get market of a opportunities world it who we United conversations. But the States, may where, has to beating going hard different chance working we are We the We process the those talking licensed to have we And are people it on when products.

that find We the will partner like. we to have those until continue we

Raghuram Selvaraju

Thank you. Okay.

Operator

to questions. showing to I turn call the for I’m And would closing back remarks. like you. Thank Keith now no over Kendall further

Keith Kendall

as and few today’s operator. clinical meeting, we We months, kickoff of and everyone obviously and the development you be Obviously, prepared critical AQST-XXX, we time. and your are for next call. the II appreciate of joining period Thank for we to a all is going you, with of Thank Aquestive continue frustrated anxious Phase around end begin Libervant. before we pivotal the the for end the trials year. get are where The

through time progress today, you all to stay And that clarity going and we you. filing. And try We continue them the make. touch the we with with that we to are of continue things, to talking to forward soon. those around your from look in to with to will in or action We go you make stay and sure we of as appreciate either again get we Libervant share all contact FDA, we the

Operator

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

now disconnect. may You

Aquestive Therapeutics (AQST) 4 May 222022 Q1 Earnings call transcript