SPRY - Earnings call transcript Q3 2024 | ARS Pharmaceuticals, Inc.

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Operator

Good day, and welcome to the ARS Pharmaceuticals Third Quarter 2024 Conference Call. [Operator Instructions] As a reminder, this call may be recorded. I would now like to turn the call over to Alex Straus of Investor Relations. Please go ahead.

Alex Straus

Good morning, and thank you for joining. With me on the call today are Richard Lowenthal, Co-Founder, President and CEO of ARS; Eric Karas, our Chief Commercial Officer; Kathy Scott, our CFO; and Justin Chakma, our Chief Business Officer. Earlier today, we issued a press release detailing our third quarter 2024 results and recent business highlights, which can be found on our website at ars-pharma.com.

a will will overview our full provide efforts, will Rich corporate our neffy team call, our Kathy Eric of for developments, an provide will today's join provide and Q&A. of an recent commercialization financial us For results, overview the brief update on

differ These the making and to subject certain factors and uncertainties, During be based SEC additional our are forward-looking today's filings call, see current details. statements on actual materially. results in our may our statements risk we'll expectations Please and beliefs. for risks

to Now let me Rich. turn the call over

Richard Lowenthal

kilograms Thank United you been allergic today. transformational Alex, and first the States mg approval single as in is who or in needle-free children everybody have greater. neffy The after Pharmaceuticals in ARS improvement dosed dialing as X or the with and recognized. the Europe same product of as are the symptoms nostril a as can you, in either dose treatment and only in of second nostril absence for A thank the for of weigh be adults reactions, X starting and first deterioration. dose months the clinical administered spray last epinephrine anaphylaxis both several including mg as XX neffy the to in X minutes soon

the providers. and As actively severe seen in in diagnosed recent warnings. by managed States box no contraindications are reactions, neffy FDA There XX allergic prescribing no the are history patients United U.S. with has who about million healthcare information, of a

improvements epinephrine lead of effective, daily caregivers signs treatment living peace at patients safe, their and, the of quickly the symptoms and importantly, administration needle-free can first for mind. in clinical to patients that easy-to-carry of reaction. Early and of of are use these better outcome All need and comfortably a and a in they of epinephrine can easy-to-use,

Eric year-end thus XXXX made will force efforts early through ramp our of up retail was into provide the we BLINKRx proud from more initial underway, also the on was progress we which a launch pharmacies. neffy to far. broadly very our available and of Our in continue became U.S. are progress, summary are launch shipment October, made to XXXX. neffy at and September which when U.S. available and XX, was sales deployed for expect

caregivers, to greatly review pounds We about as meeting, XX just the date has a option well near strong kilograms XX notable medical XXXX. are been children a pediatricians heard for September, treatment our encouraged the X positive submitted X reactions, children a interest anaphylaxis expressed they community. excitement the by future. On type potential that pounds. enthusiasm where with weigh of This in and and early who feedback March X, from as patients, with of support the we note, needle-free at payers sNDA including to for supplemental of that and for action PDUFA Pediatrics from enthusiasm recently drug in for application in FDA by mg priority accepted XX includes the or discussions the this American We neffy from shown treatment the new only allergic recent XX Academy smaller kilograms for advocates from

early approval have and are to excited we mg pediatric United are New in regions adjust company Australia, Monday, investigational outside Europe, the worldwide. with has plan a a for in China, addition, licensed Canada, ALK, Europe Zealand. rights commitments XX capability amending leading Japan, post-approval X geographic for on and XX, XXXX. allergy-focused strategic States, with marketing and licensing for November In in file EU the for Europe, to In we our the plan countries ALK to European agreement timelines neffy certain announced for very

to capabilities to significant that has conversion ALK believe severe not also those we the the but are ARS allergy epinephrine work in protected product. with expanding market, of currently market auto-injector the both a epinephrine partner, community-used patients existing a As with

million a to $XX $XXX short-term USD strong healthy for with milestones million of Finally, United puts a gives the close position ARS accelerate position the our cash cash million in in of us to neffy launch infusion efforts XXX very and States.

and at submission our and plans on to complete submissions has November. Shortly file track by in both to Japan are our December, regulatory and behalf Australia ALK, United Kingdom addition, filed In that, in approval the after in in Canada. partner, in CSL, Asia for been partners our China regulatory ARS on of in partners

around regulatory additional its demand We on the expanding are based significant filings XXXX anticipated to in global reach. with world rapidly expand for neffy further

make to numerous hear on product neffy or top offices patients had ACAI was market. every and feedback meeting can American to entering is in allergists excitement and with to to recently it their already asking name. also differentiation providers, have of needs to the rewarding positive product neffy Immunology highlighted attending who Allergy, access that care inspiring sure the as was in the its There of mission by are neffy shared Our for and health it their chance privilege profile labeling. It the Many person on Asthma College the about connect I that had shortly. I and Boston. learn

and Hurricane thanks was it critical diligently to their time first product temperature during impressed with storm. I'm responders disaster. were a stability, the the proud key extremely North And of far, to Carolina in the of to epinephrine need working been high available North prescriptions our with patients we most for connect providers engagement have that in and very allergy time to I'm approved and in stakeholders. community supply team's also able recent X,XXX to and so care the lost just who United with emergency they'll following continue needed other health who Way confident for to Carolina. are assist its Helena We of able neffy neffy

early Eric the Let over call launch through pass me to walk to successes.

Eric Karas

I'm launch since been and prescribers, some insights weeks minimizing available, team allergy been and commentary caregivers. share initial on has Thank objectives, the the access, far. executing about excited coverage our amongst our receiving from approval, Rich. obtaining with focused you, and and reactions community patients awareness the so on engaging to progress It's barriers neffy to became increasing and payers, Since X

are implementing peer-to-peer promotional We educate data. HCPs about also professional education our and and programs neffy to

of with Just there about College in X our very presentations in weeks American reached neffy mentioned, visiting neffy. X,XXX booth Immunology supported with and XXX many attending prescribers allergists. more ago, were positive at covering key the that Allergy, meeting as Rich engagement of attendance we Boston, exhibit And Asthma the over than

of at team combination print initiatives ensuring a Our and aimed affordability. and media, and deploying medical digital, conferences, awareness, in-office, our national to support promotional a presence provide access social consumer with and HCPs awareness at of significant regional national organizations, is partnerships programs advocacy and marketing including patient

are was top and sales virtual and on hired adoption early began team allergy X,XXX completed our field sales initially in and high-decile specialists managers, prioritized September, early outreach Our representatives, amongst was immediately October. HCPs. in prescribers. area the the and training, sales high-potential in focused targeted driving field team The We

serious group of potential neffy severe a by improve This and encouraged that the are reaction. to due have so in from we reaction. have community. We has we or also at believe treat the allergic involves allergic who feedback allergy to received at the are lives carry significantly to needle the enthusiasm We a patients those this injector, a but needle-related don't hesitant and self-administer, the far are don't risk event diagnosed, it, firmly of engaging treatment of who positive the unprepared barriers. wider converting are all Further, without but patients

requests. create This assist in includes We have with various home convenience support treatment journey. comprehensive the partnered neffyconnect. formulary a offers program saving exception refill prior delivery, BLINKRx and applications, patient and neffyconnect services their support with to navigating reminders, help to patients free authorization called

providing Our HCPs are neffy and services strides to initiatives already our reached date, significant has have access of care than more submitted health the in X,XXX in patients. more physicians category. providers To X,XXX decile their neffyconnect. sales HCPs have through made XX% than highest prescriptions these force and support

We have trust epinephrine enrolled allows experiencing an in neffy have to confidence This challenges X,XXX as treatment. requiring and a program the treatment testament interest in Experience a build greater result of them who patients. More in less can neffy oral allergists provides than firsthand than to our strong neffy that Experience to program, packs allergists in initiative in neffy which gain also choice anaphylactic event their is which for neffy. patients of the weeks, successfully important implemented perform courtesy food X

access especially pocket. As are affordability discussed of pays on and patient what out a calls, previous critical,

lower as allows generic device. than little insurance, offer a For for savings we co-pay This to amount average prescription. is patients for commercial needle individuals $XX each pay as program with the injector a that co-pay

have $XXX. or For high patients uninsured we of offer available BLINKRx and This a is GoodRx. plan, through deductible a who health cash are price

U.S. or assistance eligible are may residents provide our meet which Additionally, specific who patient criteria cost. program, and for at underinsured neffy qualify no uninsured can

the contracting engaging PBMs negotiations expect group in organizations decisions the insurers. of and payers, many service and major with to fourth discussions with that in coverage year. We key includes are this X quarter purchasing This we the major actively the begin and of as

interest We secure are are to product in their formulary placement. by working diligently our and encouraged

launch commercial to we pleased than more and and progress XX% XX% coverage we a are with our believe our coverage X within We track so year. of within far, are months on commercial achieve

their Additionally, support Asthma cases of needle advocate to hesitancy Immunology authorization for to appeal American resources is to and to letters prior letters related aim access help not anxiety are patients. and the neffy, challenges of to develop we approved. when Allergy, efforts particularly there supported These designed in the formulary where College the HCPs for

summary, performance you quarter of the projections, talented commercialize assembled we neffy. next track our So and far, to look team dedicated, our on we our is internal proud and quarterly forward to I'm updating fourth neffy call. In passionate, have on progress the of with during

our discuss providers. I'll financial Kathy caregivers, towards are now turn as the results. significant the objectives progress establishing and to over patients, care for health We choice neffy to of and goal launch treatment call making our of

Kathleen Scott

XXXX today, filings. our and Earlier detailed third quarter Eric. press in results our you, XX-Q release we Thank earnings reported

sales in Total the we net product includes I'll $XX.X revenue million neffy million in just the of collaboration million, third well total This $X.X week for X as just from cover quarter, $X.X highlights. In So operating million were the which ensure revenue. recorded our was quarter build-out remainder to CSL. manufacturing of in revenue expenses third sufficient from will as reflects the for of patients. Of the our commercial total million in the the meet initial well of quarter XXXX SG&A, with $XX.X expect infrastructure the in commercial as as which we neffy team. product fourth supply increase of OpEx, to of the of onboarding $X.X needs

GAAP short-term been a to in quarter me the will support plans to our net sheet call licensing Rich. third of reported cash For ending quarter $XX.X on with capitalized on November result we years. With expenses stand cash the a or that, the quarter well pass of loss at the payment neffy. We basis. We with our third that would which we pro current ended next agreement investments. continue from cash, operating let X very share, per executed for of equivalents, conjunction balance million and launch forma least $XXX.X primarily the million XX, was have over million the expect back a the today $XXX.X million of $XXX upfront Including with in XXXX, $X.XX third related ALK the to

Richard Lowenthal

than Kathy. To you, wrap is stronger Thank ARS up, ever.

product are support patients our with a we've game future have advocates, as the U.S. trajectory. neffy thrilled received a physicians, is our changer. transformational early We described in neffy and in patients, the that positive which strengthens caregivers, from confidence its epinephrine and of launch many intranasal only progress

who the U.S. with lips. We the areas To patients committed trial are technology challenging to intranasal patients are These We estimated Xb urticaria a chronic chronic to spontaneous we all it to are and for X.X initiate and flare-ups may still chronic meaningful acute an make who with accessible spontaneous experience believe the that end, epinephrine treated outpatient with making unpredictable Phase preparing flares. benefit. but antihistamines, like can urticaria. swelling in sometimes discomfort, million eyes include can our and itching, intense living difference in

to neffy in ARS line the forward again up early and and for potential in as look patients dedication We with We available follow-up far. to answers. let's the and has entire to so as making continues year incredible an execute work that. Congratulations single open dosing begin neffy updated been our so launch for pivotal questions and quickly. efficacy after you through global year into we the expansion patients keeping this that, the XXXX. With to a U.S. of with team their to study XXXX hard expect XXXX

Operator

question with first coming Cantor Instructions] Schimmer of line Josh [Operator Fitzgerald. the from Our

Joshua Schimmer

them, of may. few a have I I if

your through now expectations the what's your some made processes? adjustments latest you've of at net terms First, that least of gross thinking for in to negotiation your way

Richard Lowenthal

Richard Yes, Josh, hello, this Lowenthal. is

on we're So track still what to communicated before. we've

a ] NCE to We gross similar type products. other net to have neffy expect [ to

So achieve XX% we're that. believe is and to we're the target range expecting, still on in what we

Joshua Schimmer

And any on track that least in color for launch a the quarter. is if the with may the what range I'm there on then estimates. you mentioned you're of comfortable fourth estimates is you're not There expect out comfortable guidance we or providing internal at wide street. sure

Richard Lowenthal

Yes.

first We're the pharmacies very guidance X, forecast. on last weeks we X especially about As the X our on weeks, to believe internal really now. that tracking sales well. have very, we we're X the it's accelerate. you know, And have in provided in since have at very optimistic data started sales We or released to not any

on early, very don't well we'll the people believe still we that and future in this. disappoint are So expect, doing what but we we very, against very

Joshua Schimmer

of questions. more How about fourth the the think quarter or third either X quick in then stocking in we inventory And quarter? should contribution

Richard Lowenthal

it with We actually that was distributors to with would The inventory was and ARS. of early. correcting. out too reports. in inventory do much with to quickly on analyst the have stocking certainly has It expected, what neffy than distributors the And and probably very smaller see accelerating not some take or not do reluctance has to one than

right week So initial we the sales of was inventory of do away. to minimal because not wanting believe, that very, a take the though, amount very distributors large of

Joshua Schimmer

estimates the last for the for data? then any And timing question, CSU

Richard Lowenthal

with We discuss late-stage so CSU, be in Well, have the to protocol need of still the this is to We we'll FDA. starting still beginning development. year. discuss

sites we will to we'll We've and known. are already that investigators very expect very, able the So the be been that very involved well initiate. all engaged with be

Germany. We in in expect the to be run actually and study U.S. the

investigator on that's at depending study. after beginning latest, by how and have sooner, have current data we So we of would initiate a X plan, the we'll in the very the well-known But enrollment hope then the very that. participating Germany maybe to our And in Phase 'XX quickly goes.

Operator

Ryan Raymond Deschner question James. from the next coming line our And of with

Ryan Deschner

for A couple of questions me.

do like follow-up. versus And cash this First, as the launch? price see the what launch does the current you co-pay early evolving this then into split how And look progresses? I a have

Richard Lowenthal

between I'll little to to Eric cash as the bit? paying people any are and price getting. over are refer that split Eric, full who a you coverage speak we're or who that that people do want insurance or as far paying to

Eric Karas

Of course.

in we We what are there's a little the seeing than bit cash but that higher expected, significant we also a interest redemption product. know this

paperwork. submits success is patients When cash a prior being to submitted additional the of a without what then patients if covered see rate. So type what are doctor's about BLINKRx, we're covered, the is XX% we X/X authorization, are when are to through price XX% being And those offering them. aren't about them we any of seeing office

So as to we're what in given that bit little product expected, I people a higher and not but it. we want the seeing said, interest than get this surprising

Ryan Deschner

neffy scripts a of multiple receiving X is packs is patient, question, a next are [ ] with for then script multiple submitted X like single this packs. TRx a or it multiple numbers you logged of appreciable given for And unit units? as sounds When neffy

Richard Lowenthal

speak units. multiple you are co-pay? that combining as Is should we I believe, that. to the Eric, -- logged But for It's them

Eric Karas

I but be information, ways individual it of what there's looks are. But if there one data, that that's different in information know IQVIA reported, and TRx, Yes, that's at as unit, each and device. looking you're could lot reported there's a a like depending we on also at then

takes being into into you X takes that dispensed, patient. So than X, that per which by are if actually prescriptions many account, how account unit more divide

seeing They with have go travel home. patients for hear are line to that of expected. we when school. in to want our one want from for of that we for But kids kind the we one expectations physicians office have they So often what to

of are per number prescriptions our in we line expectations. seeing So patient the with

Operator

question next Roanna Partners. coming of line with from the our Leerink And Ruiz

Roanna Clarissa Ruiz

So bit yet? already prescriptions, auto-injector far, been the you allergy on they to been a tell newer exposed talk about And so auto-injectors can had that neffy not are launch or or have types of patients users patients if the of early these you adopters that may neffy? patients receiving are can

Eric Karas

want you do take one? that me Rich, to

Richard Lowenthal

go question for ahead. hear reason, Yes, some her didn't but I actually

Eric Karas

in From projected. is a we line it Yes. had broader with what perspective,

seeing are XX% that compliant. injectors, we to XX% not current have patients know the needle them are about We of

So easier their to be we're noninvasive, that seeing lifestyle, patients get to obviously that's going to something fit opting needle-free, into are safer.

higher our that are we So are that group, that's a injector probably the data, epinephrine have food side. that we patients haven't see those in the adopters. But as allergy prescribing that to of have some with their to are also patients early have needle conversation that on the children past a But also opting within doctor and seeing that well. had doctors or also a in are parents

Roanna Clarissa Ruiz

in And of quarterâ€¦ the early in the terms revenues

Richard Lowenthal

for so know, cannot I And operator, you Roanna some hear just reason.

Roanna Clarissa Ruiz

guys Can me? still you hear

Eric Karas

I can hear you.

Roanna Clarissa Ruiz

airlines, see neffy that? And quarters? in or see use we flow in different and I through going. bulk was seeing Okay. I you're et from there revenues cetera, any sort the guess that evidence going neffy curious about forward, groups responders, is the I'll could that subsequent for on preliminary like orders want still may discussions that keep of to quarter, you first are

Eric Karas

one. Sure. comment can I on that

more airliners with support I companies significant there the Specifically retail that the the outside emergency interest, putting together and is segment, the to public kind interest, of consider their when of kits. of kind especially

we to here with So reasons also various public lines. Very, that active temperature the knows the X both in other buildings, shelf for group kits suppliers they excursion. in very major physician as supply the emergency the along for around airliners those are ability broader product of offices, discussions those life, things well as strong of interest hotels, the the

You can it's high. the temperatures be a sometimes quite plane sitting on when can imagine

attendant, a So of mg. time safer the in X the interested They're able somebody that's the quickly something mg. administer in that's be going much they're a in not need. X as very be easier, to also to They this flight see very to interested medical professional for

So are conversations, we obviously, say those in first I movement would see those the some, and probably discussions ongoing, on would quarter. that

Operator

our question Blair. coming next Lachlan And line from William Hanbury-Brown the of with

Lachlan Hanbury-Brown

out wait One of sort real-world pointed and prescribing. adoption start versus to things have others right experience in jump that doctors slow and of of just sort the just the want that you and could that is see

you've So see what can of mean, how you're you so maybe reached to bit a talk I versus to and want from seeing real-world from far, sort the of X,XXX experience? of ready and that? now over many them are willing wait about prescribe

Richard Lowenthal

who the doctors. and even that's in reluctance lot speakers neffy hesitation, very that at all. of a what out the how and very been I probably and rapidly a we not very Yes. the of the tremendous certainly, the much I'll was is really of very little some those the of FDA fairly progressing. data endorsing Difficulty] well learning And been approval But use we're in here. any in for bit think neffy concerned came in FDA's never neffy. are had American have think understand have there's neffy. And is XX% the the [Technical rationale past approval College, what those Eric on a have before shift, of the the doing, that especially were and doctors where use are And the the benefits battle that that side dissipating. And which And also of skeptical meeting informed at less about let Experience I quickly start dramatic on then talk fact, I at think, basis the

it's of You're obviously epinephrine if indication in dosing are hospitalizations is epinephrine so the people first the and with deaths you, access then vast, having -- this to not of don't helpful. And more to vast in this quickly due majority disease. talking at critical all, not about you all. And have

very benefit. doctors get So quickly that's are neffy we why I a so we order where with Experience program saw developed that that's just think that college, experience launched that the primary big I hesitancy think we've And of and Eric, critical that, because and very, that the at in we recognize about you kind to quickly? don't very over firsthand shift. talk give they a that the But

Eric Karas

Yes, absolutely, Rich. interest in program. I mean there's great been the

over about my in comments, X,XXX, the it was have yesterday, a about mentioned as little enrolled I allergists of As in X,XXX program.

to allows firsthand in all getting that really So And neffy, experience. clinical setting, trained. when the they Rich challenge then as to the clinic only within can experience them And talking patient they've that first-hand seen profiling oral product staff their said, this have but food own a is setting. tap the into the not about is physician

continue drive program. we to So that

physicians Our is those very team PD, physicians And there good have weeks the information food prescriptions and then our at setting focused several were shared said, physicians. few as in very, with several challenge we attending college hundred a presentations on with study. enrolled there's oral in were ago our very when where Rich sales driving that PK, meeting Boston, about retail the those

are So that I comfortable doctors they as out think more there and getting is that and more information data. of see

Lachlan Hanbury-Brown

breakeven. And that ALK I sort big of and cash you upfront you've got a previously had get you to obviously guess pretty from said to

expected, than cash So ]? that bring like investment does plans extra increase the I'm or way launch you in allow sooner to DTC [ in curious accelerate earlier any

Richard Lowenthal

now key for some those and And course, had get can our triggers based to comfortably looking have again, But infusion of of that. plan. speak of that especially approach. And breakeven are previously course, absolutely. we on to we the cash those Yes, But launch plans have about to with could things deal addressed we fairly now accelerate well. that going certain needs a that very seeing later. I any factor internal sufficient cash, possible direct-to-consumer we really of large moving We of have we progress certainly, we're opportunities infusion We the very, [Technical months and the cash at achieve our to start cash think forward. fact to that's a many the some And triggers, the by once Difficulty] ahead. of was accelerate key our

Lachlan Hanbury-Brown

I Is to guess if could just another I in that as upfront revenue squeeze booked expected be quickly one. the fourth quarter?

Richard Lowenthal

So want it. do complicated But the It's kind a that of majority cash. Kathy, of you handling to very explain? of

want to So give just X on cents you your maybe that?

Kathleen Scott

Sure.

So while the the recognize this expect we'll the we fund time. to over upfront week, $XXX receive million to do actually expect revenue and receive

Rich licensing very we'll those the and it are confident into payment We're is obligations obligations agreement. performance all of the said, complicated. There certain nonrefundable. But that upfront performance time portion per obligation the As embedded GAAP complete each is recognize obligation $XXX the to fulfilled. portion performance accounting, separately at allocate of that the we of and the need value a contract of such million is to

And working accounting disclosures the on so is we're when March next filed additional XX-K have now, our we'll and technical year. in

Richard Lowenthal

can't some out from this serious a expertise answer And we requires it really tax to better figure because law. you the give

Operator

conference And will further may queue. you we time, the at questions you have today's for conclude and your ladies this and participation, Thank This gentlemen, now in disconnect. call. no

ARS Pharmaceuticals (SPRY) 13 Nov 242024 Q3 Earnings call transcript