AQST - Earnings call transcript Q3 2024 | Aquestive Therapeutics, Inc.

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Operator

Good morning, and welcome to the Aquestive Therapeutics Third Quarter 2024 Conference Call. [Operator Instructions] As a reminder, this call will be recorded. I would now like to introduce your host for today's conference call Bennett Watson of ICR Westwicke Investor Relations.

You may begin.

Bennett Watson

Thank you, operator. Good morning, and welcome to today's call. joined Chief Barber, Financial I'm and Executive call, Toth, Ernie Officer. today's by Chief Dan Officer; On We're going XXXX, to developments Q&A and provide an overview for session. third of the quarter of followed a performance by recent business

the President by Carl joined Marketing. of Steve Chief Sales Kraus, will Sherry and Dr. Dr. Science Officer; and Q&A Officer; session, Medical Korczynski, During team Wargacki, be the Chief Senior Vice

correspond with after As the release a remarks reminder, issued yesterday. the that market today closed company's was earnings

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

call, the the as included you in the report described making section as other Exchange Factors Commission sections language and Securities company the forward-looking Form XX-Q harbor in XXXX. safe X, in yesterday's and will the uncertainties outlined be remind quarterly in company's with company's the and affecting the risks Risk release as on filed as on of the earnings statements. well We company During November

of the development business its product commercialization matters with uncertainties under company and being regulatory to pharmaceutical candidates risks to any operations. other development, and approval and are company's with and related commercialized, products As with products. respect the and there significant

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

Daniel Barber

the team, pre-NDA you, joining us I in this to for our an am fourth beyond. announced last in briefing Bennett. XXXX truly call product anticipation has believe well thank August. to we a meeting. for a and to since once earnings work program have areata, candidate pre-NDA is early program and of for with last our new Thank alopecia set This pleased exciting sales Libervant distribution progress expanded launch by say morning, to completed adding everyone, X retail for be X-year-old in Aquestive and adult Good space submitted continued team. In our final months, the for what up book the quarter made study again major in you and full we and we us from have tremendous that our our believe time progress today. X- We Adrenaverse pipeline FDA a the our Anaphylm AQST-XXX

of study syndrome Anaphylm data as FDA clinical provide the The similar on announced oral focus our following we challenge dosing OASIS OASIS the without and line study, let's study. results that allergen. was epinephrine our to top allergy plasma by presence Now are requested with Anaphylm. from We of which recently concentrations the showing refer an to

subjects the or absorption profile an have been we allergen of Anaphylm from not. you same whether seen have to confirmed As our have the remains results, exposed reported that

symptom meaningful resolution this of part most our was study the Importantly, data.

symptom resolution to During administration. the the tracked administration without OASIS and with Anaphylm Anaphylm time study, we

symptoms GI to with as median well along dropped was discomfort minutes. symptoms, nasal As congestion was When resolution such as and as swelling the full a symptom this minutes. systemic throat the reminder, was of administered, time tract Anaphylm XX and tongue to tingling. When administered, lips, included XX no Anaphylm

more In are results All wonder understand symptoms from and of the and median data with to X additional remarkable we time symptoms bring the to X X something X if minutes continue resolved minutes. seeing at this we swelling progress. was that XX. This study: to fact, X, there resonate minutes The are full numbers resolution us after may treating that These showed site resolution started is subjects hope within symptom XX were benefit that of as truly administration make patients. to me symptom Anaphylm.

OAS OASIS as One in study of to community progress into medical understanding how clinical reactions of responses study, to Anaphylm questions am heard of have from is anaphylaxis. believe review filing questions, the our from our also pre-NDA questions anaphylaxis. discussed FDA's of data with for to of resulting our received briefing pleased controls pre-NDA the chemistry, submitted that meeting. from symptoms our excited is our announce ahead that the to confidence am our us that say from pleased this correlate the FDA presence application. I increases submitted we of part the Anaphylm the to we of up note with allergic response our have all and we experts, the the to found I the reactions systemic a we also it well that that to We We the I our allergy confirm and book and severe fact how OASIS have the XX% FDA gives to important FDA supportive this film up in as X% more we first had process. previously This on works feedback am to recently written to received pre-NDA manufacturing FDA. edema. I our that today

end date We year. sharing meeting, we once plan meeting FDA of meeting the meeting complete specific we the of remain before the to disclosing on from track not this our minutes, are not we final if on While the have findings our supportive PK plans our children ages to NDA we This is our submitting of X between immediately for start of pharmacokinetic FDA of and will in approximately study study. adolescents years XX the sooner. If single-dose age. is the or a pediatric then this

subject in We be to This This be will multisite expect of to go plan XXXX for spray. Based enroll we study, of FDA. the between if Anaphylm, a is filing pediatric QX and to Anaphylm. a and subject FDA conducted XX X positive each Blood XXXX on approved a then anticipated by XX expected will a continue similar and will epinephrine recently QX be the feedback dose the the home. and subjects. nasal of approved and draws study one the study will taken the enrollment pace administered launch by our

Now continue a turning they on commercial basis. grow to daily to our capabilities,

hard October, share a include space completed it in first increase dozen must all launch also sales and pleased today through retail with indicated is population. wins the was continue of you to a launch with a on to colleagues steady share particularly that X-year-old This as XX national coverage spending now I access helped agreements basis have Libervant am are the pleased resulted and Medicaid we infrastructure has and pharmacovigilance, PBMs am we on X- states, to working to X patient comes Libervant their in why successful That negotiations in of as the build we recently the of Our week This that the in and top around payers. to available in September X has Libervant we distribution market of the educating October, helpful sales affairs, been has between benefits physicians days and trend. Libervant medical are know have this with for quick us we a of prescriptions market third. I with when and management. access that

these them launch, learnings our to approved apply We will take FDA. Anaphylm by and the commercial if

efforts of we be We an towards have anaphylaxis to focus continued for the Anaphylm. efforts our increased nonpromotional our These will of space. area submission as NDA move increase in

gel. our AQST-XXX, let's Now topical prodrug epinephrine to turn

you on we opportunity our that commercial could to be Investor believe equal September Day As for AQST-XXX or Anaphylm. than during heard XX, the larger

that is of we meeting, supporting submitted AQST-XXX for our a concluding our the our benefits on study continue week, areata. This the year. XXXX before book activity of briefing pre-IND additional alopecia and for anticipate the provide for clinical to end to view conduct data goal Phase FDA the IIa Our we will to this

our begin will Phase IND We then open IIa study. the and

a exciting black box associated focus be and We alopecia will will time over an of and Ernie. patients patient We score a treatment for all program treatment worked focus conclusion, will determining reminder, prescriptions the X- to Libervant multiple inhibitor with to detect unmet areata to change JAK turn X-year-old opportunity an company, in continuing initial seeks stakeholders. With systemically come on Alopecia grow call that, truly in JAK space remain it Tool AQST-XXX study Severity we to from inhibitors. In and areata. serves the we believe alopecia our with to enrolled provide subjects. This the significant advance of score or in Anaphylm on submission, the baseline continuing towards growing meaningful absorbed and SALT NDA the high, I remains for across space in to platforms. this the for a our needs continue events AQST-XXX if adverse our the existing This without treatment serve to includes our only company anticipate advance locally continuing may for and products the warning. As the

Ernie Toth

seen By release our Thank now, issued everyone. you that and was our morning, in evening. have last you, Dan, financial good results earnings

do, quarter of we XXXX third most into discussion the results the Q&A. related As typically we address to will

we development administered quarter, our on of is no continue Anaphylm, orally During further is our a has product device, the execute carry. the that to to candidate needle, third is not support lead easy to and strategy

for advocacy activities to among for physicians, We year, and years. awareness between patients ages increase continued the X pre-commercial for and Anaphylm X community. On approval we our launch XX April received of this Libervant payers

broadening this our including distribution, age in growth third a national expanded commercial the sales product. We to have of support additional infrastructure, coverage group expanded XX insurance launch this individuals pediatric with team retail for and the of national continued quarter

third results. million increase of an and turn due the This quarter revenue [indiscernible] decreases legacy in to of third primarily revenues supply to the increase the quarter license quarter offset in to from XXXX. by the XXXX X% third partially agreement, from of a in $XX revenue supply in million of Total revenue. royalty let's increased revenue and deferred in the recognition driven Now was termination by $XX.X manufacture

quarter third revenues of in to XXXX the decreased XXXX, quarter timing Excluding revenue deferred onetime prior $XX.X unchanged the supply and to million year-over-year. Manufacture revenues, in $X.X decreased revenue. same recognition and due Sympazan the remained of $XX.X X% revenue, period total third or in of by this to million an the fees million the and primarily offset increase year. the third by Ondif quarter in in Codevelopment partially relatively of Suboxone research from XXXX compared

revenue manufacture to royalty decreases deferred and offset September revenues and $XX.X and ended primarily recognition for September was in $XX.X driven research This X Total increases in agreements, by due license months for supply revenues in termination XXXX. from increase XX, license X of revenue. increased XXXX XX, fees million of the increases the partially codevelopment supply revenue from ended to the and months in million XX% the by the

Anaphylm XX, third or expenses as to million the research development million quarter expenses and and $XX.X associated million trial well from and the Anaphylm continued The expenses in recognition advancement for the clinical $X.X onetime AQST-XXX third development XXXX. primarily and the with million $XX.X the year-over-year deferred in $X.X trial supply in cost. quarter to to for continued total X an and the general million expenses in in and year-over-year. Research allocation a research and compensation. was of $XX.X and product our increase of development this from revenues increase advancement the an for and expenses the ended of to due costs costs X cost was manufactured and development XXXX. months $X.X compensation. Selling, expenses third XXXX Excluding of personnel in September months development research driven quarter due increase third increased from This X% XXXX. programs share-based by the by was quarter million ended administrative increase with of $X.X increased of clinical The XXXX the expenses in primarily September the revenue, Research program $X.X increased increase associated in share-based decreased XX, the as of change to of partially million million XXXX,

this administrative in by to benefit higher expenses. year-over-year expects offset selling, change, and company somewhat gross see margin, Given general to positive the continue a

approval and a for X months and ended $X.X diluted third R&D EBITDA for net loss, $X.X approval the XXXX. Non-GAAP the in to to or to diluted income decreases manufacturing ended by amortization to the $X.X and share Non-GAAP EBITDA R&D increases expenses basic cost were remainder fees offset for and diluted increases the and or X for preparations XX, and higher quarter of largely compared royalty the primarily a expense ended and XXXX. loss administrative $XX.X compared XX, supply was R&D adjusted year, Non-GAAP increases Excluding $X.X per cost. EBITDA EBITDA were XX, compared for partially for million per net and XXXX and Libervant in loss regulatory million related the primarily other loss a research and for this for compared quarter million X was increased expenses. Aquestive's September spending million both offset in cash related ended was income, selling, of by loss a million was basic is driven ended in loss X and in million income, adjusted per Cash income million XX, increase the X XX, general for million EBITDA for ended R&D manufacturer as X and decreases fees X the million adjusted administrative and $X.XX loss by basic XX, of and increase of items the XXXX. of of September fees. Aquestive's the the development adjusted income, in both third the months incurred allocation to of including $XX.X excluding $XX.X September Libervant. interest loss both XXXX, non-GAAP per of loss million of loss commercial the million The million $X.XX $X the months EBITDA XXXX in and net to The for preparations in spending or supply ended XX, commercial September severance first loss XXXX. and due the third $X.XX $XX.X expenses, other loss for in by share. of debt net Anaphylm of driven September The general increased the third mentioned. Non-GAAP was year-over-year $X.X in item, XXXX, XXXX and was quarter to and million the administrative September million included months compared third excluding diluted XXXX million general increase non-GAAP revenues for to and SG&A increase in net both related The $X.X or compared quarter for expenses, The net $X.XX to quarter discounts loss September $X.X change the months fees XXXX, of XXXX driven and of share. partially interest of and share of previously $X.X the X for costs, adjusted the loss of expenses, in the primarily insurance regulatory legal third XXXX, $XX.X expenses, months equivalents lower EBITDA the ended EBITDA XXXX. Anaphylm. Selling, noncash was driven expenses, of adjusted million the $X.X months XXXX. for obligation by to $XX.X income, excluding the September decreases months in quarter XX, XX, non-GAAP by million from adjusted expenses adjusted the the to months September non-GAAP in adjusted commercial the X commercial of excluding $X.X basic was expenses, adjusted

During sell the any ATM not facility. our shares third did we under quarter,

Libervant focus ages programs patient XXXX years X We commercialization AQST-XXX on and old. for and of Anaphylm, between advancement of in continued and continue the our epinephrine X

close, $XX revenues outlined As of adjusted the of EBITDA press remains unchanged night market and last for outlook million non-GAAP $XX approximately after our total release million. to $XX approximately $XX loss issued XXXX million in million at to

of for conclusion planned XXXX quarter the the first for guidance launch for Our study meeting commencing approved XXXX, includes: Anaphylm, pre-commercial a studies, if the of activities pre-NDA engaging supportive in a by a in the FDA. this FDA quarter, pediatric and

advancement patients the epinephrine program. With now guidance the to of that, Our of the operator AQST-XXX line will launch topical our back questions. between and the for the expansion turn X ages also commercial I for line open of continued and X Libervant gel includes to

Operator

Our Ruiz Instructions] Partners. [Operator with Leerink Roanna from question first comes

Roanna Clarissa Ruiz

from questions me. Two

book. to this Anaphylm the the for main were share to FDA? what you're one briefing some topics assembling book? highlight what was First when clinical goals the to curious of I your and seek briefing for you And data able most if

Daniel Barber

Or that... you second do Roanna, have was a question?

Roanna Clarissa Ruiz

Second question was on Libervant.

I PBMs? the the with did And you if first color also how So initial was go negotiations have around that? X any curious

Daniel Barber

Sure.

will and X. over -- I'll let view able Anaphylm the So may Though of question, might not talk I then me the to gone. negotiations Sherry, give how hand you to a I'll have it give to you help her myself comment who be and or

we wanted the you it's -- at We of when we look meeting, of exactly to briefing be. goal simple. very are clinical as know, terms the Anaphylm book we for look, In -- where that

we've us of we're their shared the asked for everything package. are done to guidance to the with the on has have what completeness our provide of think the We FDA us as FDA results to looking have And do public. date. the positive, We produced we

put think we're foot excited forward, best think positioned. we our for We meeting. we well that upcoming and we're So

and In of team far. so in let terms us be with in terms the also work through her the have of Libervant what couldn't And seeing Sherry getting well. she's happier that done I'll negotiations, I walk her you positioned

Sherry Korczynski

so Roanna, Dan. the thanks Thanks, question. much for

is PBM, account these being far the getting team our patients level What Libervant getting with X as as ages both negotiations we long covered have product Our very the as for [indiscernible] the that Medicaid at very, is been commercial for in well with state prescribed, are positive. finding, as we're X, patients. -- to is

And our it as consistent. again, in is very the X into so is And reach continue is And There by we downstream to market. changer. physicians need significant it patients game [indiscernible] as X being seen payers the well. broaden ages to a unmet a for really

Roanna Clarissa Ruiz

Got quick should going Libervant. that mentioned impact we coverage start And That's follow-up to When now. Medicaid it. prescribing forward? noticed for have to you great. one I you expect

Daniel Barber

would results which a be grow I patients right to our product, drive before. think Well, we're X-year-old in we've scripts and and From to our believe we X- of to perspective, the the get than product terms to accordingly. in look X-year-old or a our that does company, to what XXXX, that better space size financial for coverage, about remember now, where that's people is scope have to would get the X- Aquestive for and in what I the perspective driving ability guided is spaces will product a limited in

point, weeks sales at this X our do track all -- force weeks? or for of with -- Sherry X X to national now place we're I So on believe in that what

Sherry Korczynski

weeks, X yes.

Daniel Barber

we're the getting so by feedback far. And really we're excited

focus the getting while to market are years go the able learnings access the financially think we're until So to to the we as forward. will places entire come, on we in are it we small be

Operator

from comes David Sandler. with Piper question next Amsellem Our

David Amsellem

have just I a So couple.

least That's EpiPen population? ADCOM, head that? Libervant as about likely payers for -- neffy, are your you segment. you the it just X into how specifically or target terms for the sales going that? you of that the number then one. Number how to sales as along means lastly, us interested the are executed Anaphylm X in that product term, and launch given with is a and core to remind you're In should keep you're Aquestive? an which experience overall count? And two, about in Is thinking audience that mission asset you how regarding of to on the to words, assume obviously Anaphylm, long regarding to prescriber NDA we is are how thinking can other more and you have it to just about this force concentration likely going what about First, particularly the initial prepare for at initial ultimately, thinking continue rights Or force question, over in and wider launching or think

Daniel Barber

me captured Sure. X David, -- questions. And so the for fun this let just morning. I think I

in go me Let reverse order.

a your view what then ADCOM. But it could for hand what of So about Libervant, talk then back goes building on it continuously last can Libervant. you so the us for we at company. look I of concentration company. I'll is who to the years, to a a on And answer steady you And close are if on one a Anaphylm. this over prescribers more question Carl, on I'll couple it your march is out accomplish trying think, question done to valuable Sherry, because your we've great as to

that think Anaphylm, pursue also and of shareholders. our we XXX Libervant, maximizing X valuable: the So products we've for those products all but the to patient Obviously, are the very all we'll different stakeholders. got value continue and

to very and parts So a with launch and running, able learnings product area, infrastructure that's our well up of Libervant in get placed. the for particular, all Anaphylm, incredibly beneficial us. we're we We're specific right all and think to very now, get into pieces

space. X-year-old comes be and X the ready So Libervant growing X- we space, and absolutely in to our to right center launch. opportunity front up and want with the now, in be is to the on When to it focus

ability whether other of that products, terms it the of company efforts to grow our not. with to hold whether our on our into sales all all people's of efforts purely ourselves or is we the falls augment In forces' or

the the it specifically. on look the always me company to best over and best shareholders questions Anaphylm let assets. But our for with what's for will the pass the of on we what's that, all to So Sherry

Sherry Korczynski

David, so much commercial it thank readiness. the Aquestive at to here exciting question. you relates a time It's really for as our

we in plans ensure We very our to are -- have have launch. we place a successful

specifically this sales well-worn the approximately force, epinephrine allergist path to annually. they the as prescriptions prescribe specialty the is to relates a continues most be XXX productive it As --

So TCPs, high for be reps, size the that force those prescribing as then answer that those otolaryngologists, allergists prescribing And our about focus physicians. sales we the large our will decile sales your and on XXX house, to pediatricians. will NPPA and on question? here expertise the of in we that have Does be believe, cover force we able based

David Amsellem

that's helpful. Yes,

Daniel Barber

Carl, can view ADCOM. your the you And on give

Carl Kraus

Sure. Happy to.

the will I this can risk mitigated that program So do. what can't we obviously, tremendously. predict FDA I say have

insight be Anaphylm and All have and most secondary intervention the for the FDA study, temperature our our OASIS it's We're recently, now, don't PH been and the pivotal the pursues. all oral possibility, of right certainly self-administration endpoints this primary FDA's or met study. of studies, have that But whether we considering or we'll thinking. for prepared avenue symptom into an become our

Operator

Brisebois from Francois next with Our Oppenheimer. question comes

FranÃ§ois Brisebois

here And could the importance to more based test And on on with a in real-world the of little So I maybe study just something study, out you just allergen should really at potential wondering importance efficacy community? work? that doctors? just help the push launches, I to of how figure the sometimes treating will was just the touched and adoption just things was some that the medical you the I with here trying a OAS because if wondering, of of like was and benefit. this if on study. site real see see in docs create world of this And something kind lot buzz just Is can the is terms wait

Daniel Barber

have Frank, data. excited I'll second I incredibly in differentiator. question. to it this through we're Yes. my perspective, to over a tell We walk you, think a pass and have this But Carl your to from full is to

absolutely as this, I'll answer far we're only that, conferences the they're As think interactions with Carl with aware, attention. let paying from ones we recent like data we're physicians several at questions. the with specific your But and

Carl Kraus

Yes. of symptom promise question. you certainly can of resolution. said that's that those time, a number both when certainly a that data cavity do cavity. think time arise these meeting epinephrine I change epinephrine I tell trying earlier, model shrink cycle for noting the hadn't does to this, probably and good support spraying No, back when a the first before, Dan the at oral cavity the there in use you, these anecdotally of with the but to about been anaphylactic not oral KOLs, reactions to delivery hadn't get was do of And an developed do physiologic interrupting reaction. Also in symptoms widespread site as direct many indicate of worth localized and of as the changes or in hold way we actually did to impact drug more have, oral oral we absorption, realized the the that Anaphylm allergists

the that we fact a my it when have underscore certainly and use think anaphylaxis. comes to predictive potentially evaluating could model that in those of one mind now about All

So useful for different many regards.

Daniel Barber

the to we with didn't I we to this days was opportunity about released I just going than conference say, and a less don't maybe hold or that time results have at ago, just community. -- XX these XX know,

going ask for an program. additional you is were big So you anyway, this question to this we because our really point a appreciate But think? up major I bringing

FranÃ§ois Brisebois

I quite No, Can a the as your much in is don't repeat I patients a prepared it not it sense. of this question to think, I was just The percentage I think lot heard as think progressed just Great. to you you mentioned, percentage makes remarks? -- in mentioned you I just anaphylaxis wanted the -- I just I in that real terms that [indiscernible]. world. with a progressed XX% of -- right. what

Daniel Barber

OAS, and reaction to in would used was which syndrome, you was My percentage deeper, prepared patients have we study, that when it so they take if Carl an can oral a OAS progress are there of add Sure. into anaphylaxis. the like for model to remarks the allergy do

says X% severe have to reaction X% more anaphylaxis. around XX%, actually literature initial up reaction the with So end a that and XX%, that allergic from it's their progresses

anaphylaxis. point So continuum the OAS we're is simply the somewhere of on making that

FranÃ§ois Brisebois

of Okay. sort of? XX% It's total? that X% X% the Not of

Daniel Barber

the of That's total. X% correct. It's

Operator

Selvaraju next Wainwright Our with Co. & from Raghuram question comes H.C.

Raghuram Selvaraju

the Can hear on Congrats me? all progress. you

Daniel Barber

hear can fine, We just you Ram.

Raghuram Selvaraju

likely filing approval of ahead mentioned drug press be that in what One to respect quickly. release Okay. you to wanted But comment the VALTOCO. population? are? And I the if population thoughts expiration prevails that of Libervant better the exclusivity to orphan future where will that currently on for to things. of could of the is Any means? Any respect was the be you the the understand of far advance to in what secondly, I with implication into With believe file? Libervant exclusivity of path us X forward? exploration provide the granularity VALTOCO likely to are is you early do of that And regarding you How you Libervant, pricing and introduction what for Very on FDA with can the in wondering in to expect pricing levels implications XXXX, the there? respect you paradigm overall kind adult that

Daniel Barber

Ram. thanks, And Yes.

with technical start a filing because me Let question the just Libervant largely that's question.

So it, still we that were the the of So have to submit in other XX And focused expires. to approval we administrative have requesting exclusivity ODE the I'll X just right? before filing, months the approval, also we we is would X it when the because complete based process for our call places. we're way on date to works obviously time

technical we'll most it's set will -- FDA work the be will it. But population. that behind X because be goal allowed scenes us and we're sell I'll rest our assured, our just plan be paperwork, up the up and doing that the the continues call to and So in to day of that

will adult only ready, be up So in in not X and approved the but and will we be that all we market.

now in is pediatrics. product you I is finding rescue to and epilepsy would what On about the is a side, rescue pricing product. launch far so right we're with in this give This this think a

be So price we found not have an obstacle. to

have We an coverage not be found to obstacle.

because contracting where found we're there's a going off not through in have still places We process. the prior

We have to prior problem. be a found offs not

and community So payer acting we understands product is of the necessity the accordingly. feel the that

to In come now reason we are full than no today. terms they the materially different we how of have believe would market, pricing have be right when will that dynamics to access they

Raghuram Selvaraju

Okay. That's very helpful.

market, Somewhat neffy market was analogous Who the wondering kind or prescribers to respect with of the question completely to outreach any prescribers neffy research of board them on neffy? high kind I kind product populations to or with appeal Since And necessarily product is are? on for in Anaphylm in preparations of as product? do precursor prescribing launch those assess of you far high-value of profile engaging prescribers, seen are to likely embodied by full-blown general sort most the might Anaphylm. be prescriber so who frequency as if not intend of to of -- characteristics that sort sort to would X what be of a

Daniel Barber

second, competitor hand what I about and would that a work the We're I'll watch. Yes. a space, who survey you this in just is things general we're preparing. the is it Sherry, general undertaking watching a But say is nice that. walk exactly could launch type through to in getting comment in of over to one Well,

dynamics, absolutely the things where spots habits we the the where and spots watching reaction, are work. prescriber So work, don't touching watching things the watching pricing

best, patient that not will the need that is continue game we as them a fits alternate to I'll exciting for most let believe for cover us, high. the Sherry that characteristics in are question I survey the what this what think we products So learn to that of -- for for work And you. is be which which about they your our space zero-sum think patients leads product looking

Sherry Korczynski

this rapidly is Sure. a using on term to so we outcomes. last that for questions. need. common game able a Ram, physicians on tell product changers thanks to anaphylaxis, it condition and you about when you, can very And why challenging it, patients. come you that? significant that think as unmet a know, [indiscernible] is is the But It's again, research, it based products I multiple are over rare few were are changers. game much in can category be weeks, has Well, their to that these launch market And you for about if -- engaged

they use have So carry. an easily product easily critical epinephrine it can for and patients so is to

Anaphylm carry. easiest efficacy of is research great working And to our top consistently. to easiest and so again, saying, back the It all of quickly And on market have comes is the to use. the that, you

closely, quick patients? watch, continue But and end has shared. Well, you're obviously, those watching, are the think, the always we're to at are adopters. we So who to we'll have as very physicians the look, of that Dan going day,

quick have to that going adopters. You're patients are

also me, are And neffy so of that patients their a will we both that prescription preferred HCPs. that believe Anaphylm with -- our finally, newly will product. we be patients quick this that filled devices, products, allergen will don't market prescription, a but just that will patients and never And or excuse prescription, their for too a in We diagnosed, have option. be patient the active avoid expanding an yet patients be that have or believe see neffy great the adopters and

Raghuram Selvaraju

quickly, And last thing very respect one XXX. with to Great.

this to Given the the Day IND you the line trial, track and Just provided sure time to indicating time relative with could are that of this be at on we the scope you still showcased previously before are make launched laid guidance Investor an things expectation that end falls out assume event? the effectively IIa that respect to effectively to Phase previous of initiation wanted within that line the of product the that XXXX? you've what

Daniel Barber

you book serious FDA. release, the from very XXX. briefing our about We're before and the comments put as We've into Ram. in very heard we've our already, press excited already Yes,

file We to our our IND IIa we Phase and going. ready want are get to

like laid we So schedule, just ago. absolutely on few out a just weeks

Operator

Our Jason question from JMP Securities. comes next with Butler

Jason Butler

about go ton product the and but FDA Can do maybe Just detail of or NIM. still a label can just including you differentiated you provide for allergy that up you here, cetera, neffy? discussion what that to talk relative study, understand oral think about challenge obviously, aspects discuss with the a do into of meeting can't -- picture I what but study, thinking debate you think help can FDA anything for pediatric et you data the are

Daniel Barber

standard, But strategy over interesting. of it hand OASIS go in with But of that believe of the our like second be global let you I'll here. could Carl, you company yes, just Yes. we a to position, that in deeper. be Carl in are that any label elements terms label a while the will little have a just in a places mentioned, like differentiation very I'll study, we do couple there

Carl Kraus

you thank for the Jason, I And completely Yes. question. agree.

with utility introducing right? a We've clearly I actually that typically think and to model, where relatively resolution created you there are demonstrated into with cavity thinking about in the oral symptom earlier, completion differentiating. We're elements see regards here are people allergen allergens forthcoming regard predictive align study. forward the to to adult food the intent on the with said allergies. But in introduced program Dan pre-NDA of pediatric program of meeting, execution with the the the overarching march as is and

considering most all overall, really certainly recent potential element. is that intent but differentiating to include the the we're as So a data opportunities

Jason Butler

Libervant And the point. streams about of revenues -- as is trends of exit royalty revenue think to should just life for for at everything but give up the we year? legacy going guidance this until about Great. tail we or kind or that's follow-up not Ernie. everything I'm And not driven streams? XXXX the a other how What you're I Anaphylm, for revenue streams But then this understand thinking now? those

Ernie Toth

that Well, -- we its It that the I the orders. that generate nature times, account. Suboxone. through we it recognizing important future to think But you're market, somewhat flow. of will our It's -- would about is the a market, will It dislocation stress said take positive an we continue asking [indiscernible] forward. cash to for questionable continues us for there's at an part generates competitive legacy flow And for But on on is as be the depend part into expect important in mostly level that we we've some Look, going flow that the think in I depending cash past, to product company. when of company. we And of we going for the provide it. we XXXX, of to guidance us. and us and is

Operator

Street Our with from comes Flaten next Thomas Markets. Capital question Lake

Thomas Flaten

then within maybe something contemplate you of from Sticking sales with cash stood -- commercial Anaphylm? does that what have Will for runway measured that XXXX, Or more the that fully guidance? a investment sales into will by for a Ernie, level does perspective? force force staffed contemplate you up

Ernie Toth

the say We've in Libervant, force said up we and here of into in not Thomas, into approval. 'XX the we what granularity have sales is also So It and 'XX. is until expanded more we ramping have any that be But 'XX, rep could But will continue 'XX. all we've launch that any and past, includes Anaphylm. gets what 'XX given activity cash launch the in the supports -- that. we that for of cash said 'XX would pre-commercial not publicly on

Thomas Flaten

Libervant? ongoing that the major Got exclusivity know to to orphan there still? there trying patient while anything anything on Is back, drug for contribution And be trying respect was overturn made. is the with to it. to argument going there I Appreciate that. a care

Daniel Barber

way Yes, energy Thomas. that now. with FDA. as back We of would do forth I not and company, where guess positioned have, putting what can call, But is our are the you we lot see we've the a I the right from

So next milestones next our Anaphylm. few on the milestone, focus is for and

I But of main the there is Our is the focus terms yes, of focuses couple for Libervant is And place building focus would milestones. getting areata behind all alopecia somewhere X just next that, clock of with run on in on exclusivity the the FDA. effort X, to that XXX watching through out.

Operator

next question with James. Our from Nachman Raymond comes Gary

Gary Nachman

need you to the still that pediatric get for meeting? need start do is still to FDA feedback, filing? that you Anaphylm, anything on after And filing? 'XX the Or visibility you're at do CMC good will alignment going So [indiscernible] you study back the on the while Or is on then And have do manufacturing study with prepping pediatric completely feel meeting? that meet the specifically the the to design dosing study before soon NDA you up? in ongoing you the buttoned all be that at the how XQ you so

Daniel Barber

sometimes view it NDAs. CMC my by much you Yes. because sections up his I'll CMC, part perspective, half CRLs for I talk No, means we it And to Gary, pass in NDA, as major way, that more of win as the can organization. our the history which, was, than view, our give such we on I'm brought occur of who to of should. CMC about as for have don't what But because from glad the that a major we over the due deep are a Steve know, a you it you think in

Stephen Wargacki

win stability needed that And possible to We all and on thank have we cleanest our you, filing. completed presented just the features is able we're a the that's to specifications, the filing. the Dan. the to we're Gary, the do work to were Having just excited aligning how of feedback our on of But important present data of exactly in you things yes, got. data, want to for best really that align we've all of possible the about the presentation that within NDA and all use big going way.

Daniel Barber

as of it, you And to call undertaking, a on the going is an major get NDA to know, that Gary, -- paperwork I'll into the the yes, FDA. prepping NDA --

all are are of that NDA being have them. we CMC -- So information, there of sections major that now the So right? one

the going whatever the document into do filing. on we is and here slotted to speak left close prepare NDA the to would work So get to that yes, be we information is as as we from gained forward the from

Gary at I'll let I'll give different that our fairly look pediatric you Carl see -- standard across me, I competitive is pediatric view. let the -- study while can and of terms landscape you the let of -- excuse think In programs, his alignment, I'll all the

Carl Kraus

dose. for Dan. with itself the would and which Thanks, anticipate study Dan Gary. the same We study, alignment X do straightforward, to our quite is as targeted The I Thanks, FDA expect do adolescent be and XX design using alluded certainly to.

anything meeting. I other anticipate So than don't moving pre-NDA after this forward

Gary Nachman

going just And just regarding And then shelf versus could Great. on Anaphylm XXX the requirements? life any is potential be what maybe neffy? then you comment to Okay. temperature And expected for on IIa that that alopecia and your be pre-NDA how on meeting, design at? study areata, you're endpoints in confident Phase in the you FDA doses terms will aligned in both the looking of are

Daniel Barber

Thanks, Gary. Yes.

the work, we're you refer right? as sciences component shelf patients life understand right? we things is all to thinking product we something daily different to product, data to right? this the in in planning this shelf important space. caregivers life temperature for ability people, to to we that different [indiscernible] patients of and think mean an what your real on of and in that data life side we we are our So stated shelf patients. And absolutely meets while when shelf that at when our lives. So robust excursion on life. making like, will needs and And look to and of our look that you calls can referring haven't our it their side, life changes So can But have important at of the the around typically experts the through which on go store and way can caregivers, what's the a like focus world it's is

view. his let areata, In terms you Carl will I of alopecia give

Carl Kraus

our did fitting BRAVE-X, as responders. that regression question. showing rely the for they of those using a strong study, Olumiant And heavily on Thanks BRAVE-X for data Sure. we're from the And the really conducted data early the that really there's where would cohort study. earlier published as we this FDA given drug approved are view reasonable an analysis endpoint the that published for that in indication, II data just extracted recently these our from for appropriately biomarker. that a suspect needs I their leveraging but and Phase

to their this do wait think have I be So responses. for well received, will we'll but

Gary Nachman

the long I timeline timeline it maybe Phase overall that get just the to but next Okay. quarter how just the specifically? you if the And was you Phase of in, intact, on second going is comment know IIa Just before start that said be year? to then data? -- longer-term IIa

Daniel Barber

we thoughts that study haven't how it when think maybe But you could guidance think some around given conclusion the yet be. give So we about just on generally. high-level of would Carl will you

Carl Kraus

Yes.

to be move if weeks. a add somewhere we'll XX going have obviously study, adaptive interim So little I of that months. XX-week that Presumably, to X able would an bit have be would all a we're we we're as think then north looking at forward, But look an you readout. to up,

Operator

James Molloy Global Partners. question next Alliance comes Our from with

James Molloy

or for you quick is come through factors deciding a that When partner? based not in the like? IIa/IIb of that hopeful think couple launch. ones. I is AQST-XXX, mean what's get post-Phase look partner that then trial time walk on self-launch I a the next XXXX are whether know what approval the a to Or to something versus a please? on self-launching you year? that decision? do post Is you've decision lines touched best. going on to what expected happens Just you get I you know that, And you Will you make us upon how

Daniel Barber

of in or the word, Jim, of universe and a Sure. for it's versus look other. lack launch, never one at white as the you terms self as better should black my philosophy partner

there, to life us ahead those interacting community always do it So grow, the of we've to we'll you've that we'll the opportunities community our around with more ability as ourselves. take we're as we are this hit opportunities our enhance company, building put that opportunities us, enhance as patients, seen the to milestones are there when we're get ability -- those when not sciences

white at, it to I making partners around continuum. And and growing very We what is focused either stay have the look management don't a think have sure on a as we So we state, at self-launch. to or self-launch. state. is moments specific partner team, the by by rather on It as and that than time we we're a black good have a or

to gets the Gary this think before. question, back I XXX, On asked

that, specific We from gave would in as when a perhaps guidance given time X-month-ish Carl said second that quarter are talk we starting it's into can the we frame. plan in for so we before, on. on of IIb. reasonable after are that, And would believe, III the of high-level as the all the Phase we that get timeline conclude. And year. view we Phase a typically, then along, would can our do further -- as XXXX. Phase a there [indiscernible] about that, Phase be III be IIb I our a the you'll on Phase materials, in and haven't be launch see obviously of IIa done next we after But would planning

James Molloy

Okay.

looking the Phase follow-up month I'm at other a last IIa timeline month, QX X-month Should that longer Phase sorry, guys -- 'XX, Just that's timeline. that. which a be more Phase a to for I'm that 'XX the likely think 'XX, QX the the phase on quick a or fourth IIa IIb present from maybe Because seemed [indiscernible]? that QX say, to we suppose it's little than quarter you

Daniel Barber

Day and to alluded discussions Investor our the Carl then, actually, since to our and I in -- adaptive he think on of focus contemplating today, it are design Yes. as we I some publicly would we study. mentioned we had are having

that from which additional is do lay So continuum a believe would slide what Phase our from in IIb. information a presentation out some Phase that would come I Day IIa us we allow to would IIb of get Investor Phase that that to there's go, that as actually

Operator

like Thank remarks. Barber you. the closing I to turn for any now to would back Dan over call

Daniel Barber

on to everyone I time, we With as our in continue we those Well, to us time be hear to we across we're continuing company. about Josh. And for build appreciate the talk you'll morning. you that, areas, hit you, the moment milestones. staying excitement several value believe for disciplined this this Thank reiterate have and the soon. we're focused we on want thank just have focused and different about you your milestones. forward, We to we will

Operator

you. Thank for conference. concludes the you your Thank This participation.

disconnect. You may now

Aquestive Therapeutics (AQST) 5 Nov 242024 Q3 Earnings call transcript