AQST - Earnings call 4 2023 | Aquestive Therapeutics, Inc.

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Operator

Good morning, and welcome to Aquestive Therapeutics Fourth Quarter and Full Year 2023 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. Please go ahead.

Bennett Watson

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

Vice Kraus, Officer; and Dr. During the will team Medical the and be joined Wargacki, Chief Senior President, Q&A session, by Research Development. Dr. Carl Stephen

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

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

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

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

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

over With line that, will the to I turn now Dan.

Daniel Barber

Bennett. you, Thank

balance in We in growth, high tremendous have a revenue our progress earnings the our We solid EBITDA, note, made again since non-GAAP development last improvements call. finished part product progress XXXX and with significant healthy cash of adjusted once a on business.

significant on While for these and future focus foundation long-term firmly achievements, solid on are growth. our building a is the

for Our simple accomplishing this strategy and remains straightforward.

X space, epilepsy peak a million by approved X could $X conditions to year, rescue of which world, the annual dependent could FDA. markets allergy the could believe buccal Anaphylm/epinephrine this Libervant/diazepam and surpass begin believe years, the early approved the are Over as around worldwide if We for sublingual in the of between space, sales $XXX if here film $X for to company rescue currently Anaphylm on in on X basis billion. In launching bring they U.S. peak be Libervant X, patients we not annual a FDA. as global film but products including sales for million. oral by patients expect the devices. transformational the product We next and to medical for the is In

graduate Anaphylm phase. commercial to to and We replenish our product the Libervant continue advance once to pipeline in-house technology

targets We dollar also will conducting peak are using our studies that initial opportunities. multi-hundred-million initial sales expect our currently human and technology indication represent Adrenaverse

XXXX. These focused come. in we a in are XXXX, well on multiple on growth the of partnerships to pillars company position that continents base know, you profitable and X to in have years growth with the we as Finally, to grew continue continuing us business expand this

pivotal should completed we in Regarding have dosing we our receive study, data Anaphylm, and shortly.

We expect the to publicly announce weeks. next data topline our within X

ever in reactions, the including more the opportunity transform by severe excited patient allergic of care to treatment We anaphylaxis. than are

past, As problem rescue population I've talked in with the with as about a when in the need patient product simply having don't it. carry Patients the product is #X this you whole you them. a

and many believe has firmly the decrease curve with reasons, bend anaphylaxis. we carrying outcomes potentially this that will Anaphylm associated bad While

months, Anaphylm I carried on Anaphylm my truly back Anaphylm several I For I case carriable the the have cards, how pocket of and is. in have testing and inside my credit have the carried phone. past with also been ID my

me, world this that psychology, means matter habit my the with on carrying product anything I a habits. film product putting can In to rescue a my XX/X my existing means exception, I've of my remember don't the stacking. me seconds. This this Anaphylm case me, without a or and phone, life. back also bring by to carry therefore, rescue to do aligned of have my is phone or referred of live with other always carrying access the I I as with For to than literally in

"All of more Academy and this. findings come. agreed her will a It's Habit We to within curve the patients. leaders well important Immunology Conference, that up leaders and share on need in exception, than both weeks devices?" of AAAAI, they Washington, held and Allergy, was advocacy able attended ago, people interactions most at tool this by potentially in one patients clinician, too our do continue I spend as the know focused I the stacking Anaphylm. existing medical daily time to over film X the said, spend is months for sample powerful anaphylaxis. Without look to front the aligns you He such and is just or do Asthma of the serving may in obvious." risk the bending carry "But of at from towards to I with asked that how our X more allergy D.C. leaders, Anaphylm who clinical days space, the better carrying American lives some resonated with of you their product fitting and

also as have the commercial for XXXX. begun We launch early as second half of for planning a

in believe indication market, the path well analogs this understood. we the Given the is commercialization for

and working We market approach, we'll and our on are share it currently marketing access evolves. as continue strategy to our

for for is We clusters On believe and intent Libervant. to the we to our using fill prescription rescue with are there note, diazepam separate of a adults gel X- is a rapidly date FDA action specific approaching it occur. when thousands a Every rectal that of seizure their month, way, a child X-year-old better Libervant.

tested in epilepsy unit in rectal an children product we Libervant and disclosed, comparable previously the group be monitoring this within gel. the As to to age have found

our of April also the action FDA benefits on are We see hopeful XX, treatment for of will date the population. this that patient

is is distribution company in Libervant of that and We continue epilepsy. that hands to the on better believe a focused CNS of

active in are discussions distribution We collaborators potential with now.

As I've said discipline, will reasonable will not realized, launch is in value if the arrangement the we we maintain and distribution product past, a ourselves.

remain discussions. Beyond Libervant we with in the U.S., business development active

focus monetizing assets assets. for XXXX licensing noncore opportunities our of on any ex-U.S. Our on expanding will our and our lead in be

is AQST-XXX, which Regarding we that believe formulation move forward potential This we a application indications. among out comes topical Adrenaverse pipeline, platform. our has future to cream with dermatology our of continue

dose characterizing our AQST-XXX is focused different the clinic absorption in currently study, the We which profile of at first-in-man on levels. with are

have this in will We year. the say to more on later program

we In growth. year the XXXX focused the and for foundation phenomenal conclusion, long-term on a was company, are building now for

X the with remain on data track upcoming Libervant next on date action in April. Anaphylm Our weeks late expected an FDA milestones and in

NDA an XXXX. towards guide We continue filing to Anaphylm in

remain Our and activities collaboration ongoing. robust

With the call that, I to turn Ernie. will over

Ernie Toth

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

address we the the will typically related fourth year the quarter Q&A. discussion results most full As to do, we XXXX in and of

as Libervant. evolve a with generating and billion a Anaphylm company produced strips key platform We X business validated continue pipeline revenue, a assets, X.X base solid over having and to

position expenses quarter, our only well to to our on refinancing delivered continued Anaphylm, continued execute the the product, epinephrine runway our extend lead the to product. non-device-based expanding first orally cash our to of we strengthen strategy as our During managing as development fourth debt financial support by and

Anaphylm until of Libervant the Libervant. and royalty of a of sales transaction, and the XXXX. for between at on The quarterly. financing As from corporate the XXXX. notes a XX.X% XX.X% facility maturity entitled noteholders large on the financing global of senior first earlier connection and the basis. X, institutional interest worldwide of royalty purposes. prior sales investor mature per leading date we was of new tiered to of noteholders XX, outstanding fourth general repaid X% repay Anaphylm June granting net sale annual tiered starting obligations Aquestive of by the The years had a payable period secured The a years royalty entered XXXX. In also the of will that first secured X% X% bear rate the to credit to a will November for June worldwide year, on Principal used Anaphylm be a refinanced agreements, with of the of notes quarter, senior XX, are all annual reminder, of The company from first under a fixed during into a and between are X net of the sale $XX million X% obligations X notes sale

Importantly, of cash non-dilutive of future Despite structure contain reduces short difficult cash our this to XXXX, and June the the date no the the our market step approximately an important of no represents term growth transaction $XX the stock. The conditions, flexibility notes invest maximizes revenue the in million facility. for investors' refinancing covenants of continued warrants XX, forward through in or the original due company's by and requirements willingness credit very purchase Aquestive. in our

Now quarterly recap full turn and financial year the our of let's to results.

of in reported of the Azstarys impact million Sympazan, of the the a due $XX.X milestone million fourth higher in out-licensed million in quarter $X in quarter $XX.X XX%. was XXXX, Therapeutics royalty revenue quarter of total million X products. Total to the primarily were XX% and fourth for $XX.X million XXXX. This prior revenues $XX.X increased of XXXX, payment fourth from the to the from Zevra increase quarter proprietary an revenues compared company's to increase sales fourth onetime XXXX Excluding year

prior Zevra, and to saw and license million in research due in manufacturing for manufacturing fees a period, and Sympazan increased of to revenues increase Suboxone, in quarter co-development revenue Ondif XX% a fourth royalty Brazil for of million the to we compared for the million Azstarys a for in XX% $X.X the due for decreased licensing Hypera $X.X revenues and $X.X revenue. revenue increase XXX% revenue, offset and by milestone supply For mostly increase XXXX, from

proprietary the were year of in out-licensing year agreement to manufacturer prior For the of increase Total excluding of year XX, change XXXX, product full for Assertio ended with of XXXX, XX, ended revenues by December of XXXX, in $XX.X October XXXX, year offset and Sympazan, the compared $XX million year $XX.X royalty XX%. XXXX. license total discontinuance supply for reported increase from full an sales revenues million to an Sympazan the was and of subsequent X%. for revenue, The sales million for full million the to the impact and the proprietary increased the increase December due year revenue XXXX, to $XX.X

was of revenue Sympazan. million $X.X change revenues compared due to same period for and the year supply increased and Manufacture XX, XXXX, XXXX. ended million for $X.X to Suboxone, million Ondif increased for $X.X million in December $X.X the for or This XX%

due License period research and of $X.X Azstarys. $X.X compared XX, million revenues same revenue Sympazan for increased the $X.X XXXX. in million, or Zevra, $X.X XXXX. compared XXXX, of XXX%, the same million royalty and $X.X Azstarys and for milestone to XXXX, the X%, revenues year for increased million This fees in $X to million, and increased million or December for year in December licensing royalty for ended revenue of Co-development ended XX, royalty was to revenues from increased change licensing the period

ended year to due the December the revenue in product decrease decreased was XXXX, in fourth same the proprietary product compared sales million to XXXX. of XXXX. This $X.X Sympazan XX, Proprietary the sales discontinuation quarter for period of

fourth described was on This million share. quarter the in the $X.X expenses, the was increases administrative for per $X.XX debt. partially higher or loss and per administrative related XXXX lower and $X extinguishment subsequent was expense, our decreases costs, for amortization one-time of organization $X.XX and loss XXXX share. net to million debt of in decrease of out-licensing loss The including the selling, driven to refinancing in loss interest net offset of million of severance revenue loss the net costs Sympazan, by discount a commercial debt in on $XX.X the loss and reduction fourth Our costs or general by in quarter above, development a noncash expense research of XX.X%

costs monetization our was net development commercial consisted and of and expense, and full debt to BioDelivery year general increase net million, decrease net including The was previously and of discount year of share. the related $XX.X settlement extinguishment a amortization Our lower amendment million lower the loss million per research refinancing higher in interest $X.XX Exploitation million in million the on the share. loss related administrative partially noncash the the revenue, significantly expenses loss $X interest in the by costs which to the offset XXXX severance from in driven and full income litigation as Indivior in loss from and by costs debt. XXXX expense per $X.X expense of KYNMOBI was organization. A other Commercial an with and decrease of patent $X.XX of for $XX.X $X.X reduction administrative loss noncash transaction, described; onetime million to Agreement, Sciences $X.X or selling, or debt The for International; XX.X% the loss

EBITDA $X.X $X.X in EBITDA XXXX. million year-over-year the the by in Non-GAAP year $XX.X non-GAAP of change adjusted full fourth of quarter full $X.X fourth the expenses, $X.X was items a $XX.X million EBITDA EBITDA excluding driven to to EBITDA excluding Non-GAAP loss in loss adjusted loss, the XXXX, a in described. adjusted fourth year in was expenses, adjusted the compared million R&D adjusted quarter quarter adjusted quarter previously non-GAAP XXXX, adjusted compared XXXX. Non-GAAP fourth R&D for million The loss, the compared XXXX, loss was in loss the to XXXX. million million was loss

the R&D the for million XXXX, the EBITDA XX, the approximately million excluding adjusted during accessed as adjusted full XXXX. XX, of adjusted cash expenses, year was a at $X.X December XXXX. net million or fourth we for compared Non-GAAP $X proceeds expenses, R&D million were million $X December The facility, facility XXXX non-GAAP adjusted $XX.X excluding the $XX has income, EBITDA of to At-the-Market, full year Under for ATM available full equivalents year loss, and XXXX. Cash $XX.X quarter ATM XXXX. and of million

million. December XX, XXXX, In X.X warrants approximately addition, with ended common proceeds during stock the exercised million year were of approximately $X.X

Our our of focus topline following from continue to program with XXXX end Anaphylm year. will reporting NDA in the advancement the by FDA trial, of our data the pivotal and be our

$XX approximately of after financial million. non-GAAP XXXX in to guidance issued $XX to As as night last is $XX million close, outlined Total press release $XX market the full million year of revenues follows: loss EBITDA million, our adjusted and approximately

Please include revenue for note, does guidance Libervant. any not revenue

the continued back now investments XXXX Anaphylm, orally first guidance the to operator questions. will to the administered related the for open addition, epinephrine development to line turn NDA R&D filing of In and line product. I for increased our the includes planned

Operator

Brisebois [Operator first Instructions] question The Oppenheimer. François comes with from

FranÃ§ois Brisebois

Congrats on the progress here.

dose for here here? couple What help of me a single for expectations X be can just PK/PD just here. help should -- and you us repeat away, us Can So we're in waiting data? you set weeks around maybe terms we just

Daniel Barber

perspective, Sure. it be about and who looks over Frank, success we we, well, a will Carl, you I'll then, outline can think from releasing to for turn side, tell you our from what like. what package I'll

study. of we've as all perspective, data we'll over months, few our package last the a pivotal shared the From from have

a it meeting data, under have from think Type can event. our pass you what findings over a repeat a tell with But meeting who about, you dose. Part We'll Part is there's which single part, B, also dose of and a to the looks we'll success C FDA from like. let Carl A, which all have me perspective, we if and is that a So recall, our

Carl Kraus

Sure. over be; of curves achieve products. demonstrating of listed sustainability pharmacodynamic question, successful our our RLP, Thanks, of our Frank. are as expecting outcomes that north able the period of related and the one, that would we're The as reference Dan, well are to we for observation thanks demonstration biocompatibility pharmacokinetic to data here and levels

X of demonstrate items would, minds, those our in with safety the success. of conjunction in So product characterization our

FranÃ§ois Brisebois

Okay. you peak sales And talk and in believe billion, of terms breakdown? I a Anaphylm, help maybe If of how $X the over understand potential us big commercial here maybe did can get, you that just was worldwide. about EpiPen

ex-U.S. So potential, the market market and maybe a the versus breakdown U.S. of

Daniel Barber

Yes.

just the have terms looking of One, of at don't So unfortunately, couple that is in right, you prevalence. I need growing, there's so -- dynamics the need sales we growth, and its at as that anaphylaxis a market a is But as U.S., number. play. EpiPen height, the globally for allergic way are reactions it the the severe here at not but does in peak have and

there's you gaining two, the people anaphylaxis. access the for more and And are medications at systems look different world, rescue healthcare more as who around to

-- So the we've mark we global done, one. the that on $X basis is do a work a reasonable think and billion

world, part the how of of most and terms of is I the think of typically, true the U.S. the of is that the the in U.S. stay we far to industry versus much opportunity. the In larger that by rest

FranÃ§ois Brisebois

lot take I'm is, just market use a versus it be to And product and the then to the likely AAAAI, and we're fair? you that not auto-injector? kind reload minute at be not use or waiting fair last to Is say -- auto-injector. versus the until waiting a the having might people are of more an product Is that taking just of use on -- guess when refill long and at it? take earlier, Or obviously, to they're prescription kind versus just and getting talking you would what it to patients spent about willingness bigger? do time that waiting even probably If to too all it it patients of it. I the And

Daniel Barber

carrying by and that of prevalence are No. ties know global right? not rescue previous as that larger and say And about, than devices. that rate, kind Frank, I opportunity Yes. use is the as into meaning your rate we didn't is the outlined as people question, I the What talked simply we far

as do the alternative So carry think use product. be come we technologies will willing to and more the that into people ours market delivery like

And is AAAAI. it at AAAAI before, products it's an the people a hear funny more for easier back they lot truly sure rid seem making that that believe do understood it. I with by need in you when carry, by should product spent remarks but needle, of And we they and to to as carry -- opportunity was creating to to reaffirming them from and and our mention hold physician perspective, the perspective. patient true time that with physicians I their there not the perspective, just it a is talking getting have that physicians believe do put my of beliefs the

FranÃ§ois Brisebois

Yes, expired Okay. we're like it an there's products ones seems Great. unmet anyway. that seems need, lot it people -- even like hearing of the the a that's clearly -- and carrying,

Operator

comes question JMP Jason next with The Securities. Butler from Citizens

Jason Butler

work physician-targeting, but get can the going that your back Can terms do to submission? 'XX. the of Dan, between for talk kind maybe you spend, ready for be you throughout you're et a about And about data can going to the in the of to work building be getting regulatory at end ready cetera, you and obviously, prep do awareness, launch you gating launch? talked a doing, of commercial you're the work just what's

Daniel Barber

Jason, very the the position that even onerous for large have part X spend And actually, the can't in Yes. the elements, our handle. is a activities. we of levers you we right, We XXXX, commercial a of manageable that do be not and which way that cash will -- your amount you that XXXX, given in us our question, it's set in business, important put asked No. believe and first the

focused some are, exist market awareness. now activities things launch. In terms in one far not the by as of important dynamics what that only that alluded awareness to is the to, an right is on already the factor in is prior of our of marketplace growing, the but helps you are competitors And those us also

them alternate just So the the at and aware by look of helps be times to that we to to market. come having nature, products available people of necessity of them rescue a of making will with the as all -- product

of other are who with people make base that make we will course, we is side, get sure people of infrastructure clear and focus terms as company, our think we we messaging of we will, so the the dealing on, In payers, medical who closer course, to have will, in of the launch. are sure the that activities our ready affairs and on

Jason Butler

then And you XXX, the what year? absorption briefly later look target can it. on -- just ahead PK idea an we Got for when data looks maybe this level us high like a to profile at give profile just or

Daniel Barber

Sure.

So for Carl. to that pass I'll over it one,

Carl Kraus

Yes. last the well bracket of that drug staying been bracketing the between within a at with and the north of least at and auto-injectors. the bound as duration on where be been reasonable committee, what advisory reference year's all reference targeting PK of ourselves that is The drug a remains of discussed observation it has consistent within we for as profile is listed which PK listed are north would along, curve demonstration a we've the

Daniel Barber

lower be we really lot gave IM. that And in we will think he it first place than that -- a the want one Jason, the XX said lower particular, in minutes manual you about the believe, I way a don't to is that in here, talk north, Carl be, important point

terms market. where can So for of be above we're look to everyone that that's able a spot in that

Operator

The with Andreas Wedbush. next from question Argyrides comes

Andreas Argyrides

here. us from couple a Just

a of penetrating to currently Is immediate about billion? look target then should X thinking don't those So script which given who don't, the EpiPen you on Anaphylm patients what And looking you does goal less ahead how are are that, those carry to than against and segments it? is market competitors $X the opportunity the how who the commercial and the of thinking positioning outside generics, fill lastly, beyond the various about and market segments? for are market? Anaphylm, And

Daniel Barber

to voice. your hear Sure. nice Andreas,

to the launching this of go product our It's launched through to about think all that to task. market, I sure I to more So parts FDA a is us been bring think products, the of think, simple. through launch the a pieces other have Of that all is the the space. actually to similar to way comfortable have is all obviously in getting way very we and that packaging products is make in difficult work fairly the believe of

terms straightforward. very of our process be penetrating, launch will In

a didn't people who are into have or go a or after script it, work either the to You a people fill and never the carrying used anymore your using have. gotten an then, EpiPen, and have be to don't you should who and script, already first and a where product carrying segments product carry or point, your way

competitors be So sequence the it follow process process. that I would if same is a surprised our didn't

or have -- before, biggest be been important is some say is it we In people that believe are likely the advantage I'll of disease for the -- also it we positioning, way. of When which advantage we advantage in our product, single products other make our know, earlier that, other idea we of look an we've with we the to focused use And set the not is at clear, to but some there of today. the data right will believe believe product. having compared we products, you. But uptake had an I sure marketplace it this state think people terms the why, in could market. think a people shows be that's as a or are a they that benefits providers, clearly, are product because product just you remarks not of of healthcare other carrying rapid very compared scientific on rapid with my very think And the them it about it I is particularly oral we there where carrying in median do epinephrine, our the has Tmax, the you faster to be may for to an in of to potential the data, that an carry

Operator

looking to progress. the all And forward upcoming Congrats data. on the Okay. Great.

Daniel Barber

Thanks, Andreas.

Operator

Lake Next from Thomas Markets. comes Flaten Capital question with Street

Thomas Flaten

the do as all or but year. possibility need of did commercialization, we open guys leave done it on progress with later Libervant you what the lot on Dan, Congrats Any a well. you've what this if talked launching commentary timeframe might about alone go you perhaps and Anaphylm about you to we think that?

Daniel Barber

And be. right of you FDA we're asked has questions of outside Thomas, we an and Libervant decision lot Anaphylm, Good perspective FDA there from date. now, up. awaiting around product. Sure. morning, answered, the of Libervant is a There's the and brought should I'm important excitement But an glad both and inside all the had our as company,

drug people to occur that have remind you orphan think I with product. this challenge an there that could is

months see and how obviously the of couple want get that unfolds. So past next we to

believe would the I interested where not to would launch we've look I with companies unfold able job fair the launching do Having that. we were would we that, XXXX, but as second half talked get product, are If that the we of and not to about, deal Libervant, epilepsy-focused to point who that do in to a appropriate said there those good not do were or could launching would only be Libervant.

Thomas Flaten

And Anything us an uptick past one-time there guessing for I'm with quarter kind Ernie. of respect Great. year. a one Appreciate Ernie? help Gross for can some fourth was And you were gross margins, of a that. margins place little this quick all the to over royalty bit payments.

Ernie Toth

payment to milestone Zevra is biggest the Certainly, the good to the talk Azstarys. Thomas, recognition from you. of item for

fourth in was quarter, So there the $X no associated. million cost that

that impact have on would an So margin. gross

Operator

question next The with comes H.C. from Wainwright. Ram Selvaraju

Raghuram Selvaraju

all you hear on Congrats progress. Can the me?

Daniel Barber

Ram. Yes,

Raghuram Selvaraju

these quickly, for you submission regarding wondering up products, of kinds outlook just updated any And very thoughts additional you epinephrine recent see the respect to for the any NDA? had Anaphylm. I perspectives the neffy? to there of developments as with if just was you gear given if delivery particularly with So alternative regulatory Anaphylm

Daniel Barber

to Nice And through them has voice, spoke that the is lives, Yes. a FDA we are FDA way all Ram. works to doing make that the use. else is perspective, it the to actually to from our or work think your to of hear supposed it's rescue first for sure anyone about do to we FDA creating product to They the product experience anaphylaxis been that a under want consistent. From product, sure very today, do make their supposed we the all the in our conditions believe job. with save we're time we work has potential the a if we with that

and competitors, market why is So and think that's look us big we be they will a responsibility FDA that our they confident the about understand how which package in at is we continue approval. how we robust, for that, are the our and and to understand consistent

to like them least being at hear through public it public when our And from In the just we competitor, think then you. the the like obviously, appears us, terms is of consistent about a with we and domain given that comments from through just as is well, we distance what is competitors. FDA see coming our what read

Raghuram Selvaraju

Great. Okay.

be how have a kind regarding the pertains do for this product potential those? Anaphylm broader any as Anaphylm of opportunities of with States outside of franchise, a value respect to that United may exist that, sort optimizing of you access thoughts the any to particularly able might strategic as you and to also Just as

Daniel Barber

we -- have are goes right? the that's of given of in all. From point, Yes. the long-term at growth, We Ram. do the good own where time this point launch evolution, idea our really at and a this in back on outside company to U.S. product No, our designs not to

world. we done be, actively potential like So we different will we in partners markets are, -- with the talking and with have Libervant, around

regulatory has an the find Anaphylm the once us, right We support thing the get yes, quarter a is For part sure to to make tomorrow in launched. story find where we been anything through like the this different Libervant that. have is about the ex-U.S. product it both now important nice Aquestive and partner we process for right we But can of markets potential. partner are or don't or also the and

Raghuram Selvaraju

I'm Okay. month. item. as of just of the sure asking that And this cyber Healthcare very all last you housekeeping I'm occurred a attack are and lastly, well aware Change

to disruptions wanted cyber the processing case any know may Healthcare see? your you whether relevant even ask really prescriptions. Change your that that's impact XXXX I don't and to from the for potential of Just guidance attack in whether includes

Daniel Barber

to do but the Yes. No, company public we I comment see affect you is, a attacks the expect company, for of IT could you as even to just our give -- don't that all only impact any from that protect do a would Aquestive, to our would XXXX, I for things business. cyber

Operator

with comes from Alliance Molloy Global James Partners. question Next

James Molloy

that you encompasses? of I us the advocacy walk -- in question couple bit and sort a networking how -- through on Factors that can that what about talk Anaphylm launch you of Human had played advance has program. or And how groups little out? allergy to then a the a outreach questions, Can of

Daniel Barber

make of X all work. advocacy is want. to rights to are are national morning, From probably space, protected and this in mean, as I'll level, hand to phenomenal all question there take access Good looking the groups who then, know, you and advocacy the over it sure you I'll great second can where talk you or drug work at to Human the that about of Factors roughly them just are would Carl, and things first, a an I patients' Yes. James do -- Jim. perspective, they're program. protected and

in relationship think having supporting So good a we and the groups advocacy space various that important. the do is

We done that have than -- look if that. of most more actually we did our competitors. at last We even year, even you

them at seriously that as take So we they to the support can we met work all them with shows just it. and as We ago, few how do weeks best good they do. we'll you that AAAAI of continue a

over the Human it to that, I'll Factors. with Carl But turn on

Carl Kraus

question, thanks Sure. and Thanks, Jim. Dan, for the

As process, is far as different. aware, programs Factors no an you're probably as our and iterative are Human goes, program ours these

and might technology pediatrics a evaluating technology and how patients interactions the engage pathway in caregiver their We between better our our adults, we understand where are patient.

have great those goes on process is protocol, that support, progressing we gone of formative between So ongoing to that's then we completing a ourselves that's validated the midst iterative that efforts through lengths ongoing with through and and a and are which schedule. an typical in FDA the process and dialogue, so

James Molloy

your on I that certainly seeing any busy the to or you keep potential? looking horizon, But plate as the follow-up. you potential get plenty pipeline? what you to Are bolster candidates bring on coming beyond do All right, to then Maybe great. quick up. things acquisition you see board know X

Daniel Barber

where I pipeline Well, look our would at first is. Sure.

about love with beyond AQST-XXX you we but the are Anaphylm, about I cream. we on and looking what work. look program, with say. excited now with to know And the time half haven't more clinic it second topical see of a we're that you that are spent doing the we'd talk definitely to lot we having public we in space, the a actually opportunity forward actively in year, in We're of as the to If more. or right

on on, the of right now lot plate on right world, think on our terms Anaphylm the we to to package. results I acquisition right and with deliver a focus have time, want and schedule the we In

focus but So that obviously, we'll be public now. is opportunistic, like our there any -- right company, not

Operator

this to Barber would back at Dan time. closing call no remarks. like I I questions further for turn show the to now

Daniel Barber

joining couple again for next good the Thank with day. speaking of exciting a in today. Aquestive, you of to Thank with all weeks. we're time forward This have I hope you us is that, And looking you you, Michelle. an and for

Operator

your call. This concludes today's you conference participation. Thank for

disconnect. You may now

Aquestive Therapeutics (AQST) 6 Mar 242023 Q4 Earnings call transcript