Earnings call transcript Q3 2022

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Operator

Good day, ladies and gentlemen, and welcome to Achieve Life Sciences Third Quarter 2022 Earnings Conference Call. All lines have been placed on a listen-only mode. And the floor will be open for questions and comments following the presentation. [Operator Instructions]

At this time, it is my pleasure to turn the floor over to your host Nicole Jones, CG Capital Investor Relations. yours. is floor the Ma'am,

Nicole Jones

after Thank you, John Principal Achieve have for call Officer. On Chief Executive today's Q&A available Bencich be Wan management from prepared Officer; remarks. Achieve we will operator. the and Accounting Jerry

that to with are Achieve contains statements forward-looking conference like SEC those to filed and predictions website available actual on I'd on company. the vary today's expectations. projected. materially refer based from current call factors concerning that document our everyone remind affect the These only statements results may and Please could

I'll now turn the call over to John.

John Bencich

Nicole everyone quarter and for Thank us you, exciting again thanks today. yet It was Achieve. and joining busy a for

through we in nicotine closer clinic dependence and the two treatment As cytisinicline to decades. for to nearly continue the first advance becoming new prescription

we enrollment nicotine trial cessation. last And III target our enrollment In completion the our just of ORCA-VX vaping in of Phase smoking in for earlier-than-expected ORCA-X for September, e-cigarette confirmatory announced or completion cessation. trial announced week we Phase II

As second overwhelmingly trial this III and the authorization mirrors ORCA-X trial of the submission out FDA read US. final is earlier ultimately in and that the a required for Phase The trial previous randomized positive design ORCA-X results that with reminder, the year. marketing

medications. the were during also The for of evaluate treatment the to either trials X placebo. or approvable same efficacy, X-milligram to weeks abstinence daily is to cessation designed a cessation the weeks tolerability Both trials of period last evaluate weeks primary of cytisinicline and smoking smoking times endpoint safety smoking the which over dosed three share XX four endpoint FDA's compared

new events been available approved of belief adverse our side The has rates potential become effect treatments. outcome With is the treatment if seen further for to standard than in cytisinicline better cytisinicline what of has of gold single-digit ORCA-X strong profile substantially nicotine dependence. that enhanced the currently

six placebo. with we times odds observed times end to odds of higher unprecedented in the From quitting ORCA-X were perspective, ratios the compared at to an efficacy eight treatment of

were the with execution of the Additionally, those see addictive results to forward quarter hope of sharing in quit a second despite look to study the rates similar highly and our you impressive from the during We ORCA-X XXXX. pandemic. trial population and

students Vaping last on particularly of continues million to important to the e-cigarettes an alone. new reporting high adolescent The users global in the rate topic school week potential middle scale, users than more be of cardiovascular current with health. indicating X.X a released school were and data the data impacts US CDC harmful respiratory alarming and and

There are vaping also approved more cytisinicline adult be than ORCA-VX and trial no We treatments currently pursued for users and this interest to population. underserved products of of expectation growing vape US the cessation. would the are XX with the million nicotine that in specifically

The roughly for within to swift population. assumptions completed was five of enrollment in this subjects ORCA-VX ORCA-VX's recruitment reinforce of treatment Recruiting appears our of clinical XXX target four the only sites, trial months. demand at

XX will ORCA-VX weeks evaluate placebo. of versus design the cytisinicline Regarding

behavioral support receive the in also the data weeks is of four for levels confirmation as objective quarter XXXX. vaping last be evaluate expected cotinine as other Top-line As second will abstinence. of reported throughout biochemical defined to will ORCA-VX for to with nicotine for treatment abstinence The trials ORCA cessation the weekly the study. participants with all primary of successful be

behind attention we key trial us, turn months. With to over the enrollment two three coming the priorities milestones our

our trial clinical to the sites research lines. First, to, time data continuous ORCA-VX ORCA-X engagement and and ensure organization adherence clinical reporting accuracy third-party with and

the ORCA-X filing. completion results, required remaining in filing including U.S., Second, trial successful the for extensive supportive preparations to support the an of NDA post trials

of potential to who closely capacity parties activities partner readiness to launch. readiness launch Sopharma, the including, part our continue cytisinicline. adequate with at our Also, of and also work as partnering discussions interested commercial with ensure believe commercial manufacturing preparedness objective, immense Third, commercial in we

As a new suite API annually. primary Sofia. cytisinicline we its purification million and complements three announced today, suite billion produce dedicated Sopharma of in the to capacity build-out more manufacturing plant API than recently nearly to The invested €X new Sopharma's tablets complete

I would the to over financial call third now update. turn to quarter like the Jerry, for

Jerry Wan

providing our as position our Thank XXXX operating you, third reviewing an expenses quarter. cash John. I for September and will XXth be on of the update

XXXX, the million, to and investments XXth cash As short-term of XXXX. equivalents, $XX restricted compared were cash December as XXst company's $XX.X September million cash, of

million evaluate received e-cigarette the for nicotine support use. NIH includes ORCA-VX awarded of use Phase forecast from the grant, Our to cytisinicline X from cessation of the the reimbursements as treatment $X.X to cash trial, a

As a cost the are the the the, funded from trial half from ORCA-VX grant reminder, of through approximately NIH.

Net our of XXth loss September ended operations, XXth $XX.X September to for period $XX.X million months compared ended for to nine respect same million, statement $XX With loss XXXX. XXXX, of increased the XXXX of quarter compared $X.X the to XXXX. quarter net the million for same million to increased the for to

quarter, expenses ORCA-X and our ORCA-VX in initiation targeted the the enrollment trial. third of and increased with achievement trial Operating in our enrollment in

expect completion. We in fourth will ORCA-VX half and XXXX, ORCA-X first remain reach as our trials in operating quarter reducing this elevated the of year the expenses quarterly the of before

the call my now turn I to back concludes John. over financial That will remarks. And

John Bencich

completing a successful pivotal XXXX two other the Jerry. studies. X year and results been important Phase for has Achieve, with key enrollment being in trial Thanks, highlights

on pleased commitments deliver are treatment. our we this to the to have We milestones and we made continue forward bringing new that important

to the there one more who smoke million billion people XX people directly addiction due impacts than remain and million the globe. X.X die smoking-related each nearly In year, Smoking alone, U.S. and than around people nicotine illnesses. more

smokers new. something the smoking In believe an conducted interested In analysis, appropriate we be products. they in a be quit, we most stated XX% would new XX% to current with recently cessation who cytisinicline, segment will want for overall, desired

More dissatisfaction done have be and people for a unique a to improve to their with lives. high and rating are difference new a have to both real needs smokers available long to and prescribers help to are that opportunity quit cytisinicline. who We we make treatments current extend believe and The want responsibility and overdue. options

all thanks operator, joining over today. and us to your Again, the questions. support the like for now call open for line to I'd turn the and continued

Operator

you. Thank open The [Operator comes Instructions] And floor is now Lake Thomas question from ahead, for first Thomas. Capital. our Flaten Go questions. from Street

Thomas Flaten

I for might ORCA-X. curious publication taking questions Thanks and congrats just of have on the I was Hey any my all insight apologize John progress. into guys. I -- so this much missed and

John Bencich

Appreciate Thomas. the Thanks, question.

in the primary investigator we Nancy the Rigotti, is activity an is engaged particular ORCA-X this who Dr. So, that, are with on trial. in, actively

So, and manuscript the to get we have that that's draft we currently a in future. being submitted near reviewed hope

Thomas Flaten

that Sopharma expansion, approval launch? done your specifically to the and And support pending then on was

John Bencich

correct. That's

So and to as the API appropriate that to that sure just completed this new that we in to throughput suite forward cytisinicline furtherance making of we've is XXX% look was market. recently was dedicated that got program move

Thomas Flaten

other And early, them into in are to I'm required let if a that me do pre-NDA FDA expansion interim? potential guys with you this or your to a the is to ability and with meeting that's discuss know. there's vaping steps squeeze it in intention the going data you are assuming think And do the label incorrect, please

John Bencich

Yeah.

Let me hand that Jacobs. Dr. one over to

Cindy Jacobs

Phase won't at that's safety data. we indication would we but small is with the doing have the enough of vaping to be discussing vaping will looking Hi. including because label. efficacy, a Yes, after then FDA We what need II, that one add approval Phase in get smoking be we study for the to onto the we cessation would have only study III

Thomas Flaten

Appreciate guys. you Thanks, the Excellent. questions. taking

John Bencich

Thomas. Thanks,

Operator

Thank François And Brisebois question our ahead, Go you. Oppenheimer. comes next from from François.

François Brisebois

taking here. for question you the Thank

seeing And your here? doing how just product? removed do the you well any I read-through being any on pretty So And chance generics wondering, see are from was how market for just then that's it's updates doing? you

John Bencich

Yeah. Thanks, Frank.

XX% here And generic we previously from XXXX. a entrant have the first look sales in did in put be earnings they achieve mind product They're to have has reps $XXX that a way marketing to that QX been not in been Endo we've and So be. as think and they ground. million indicated run which is out it Pharma with I their of from on before last the Endo script market rate saw volume would we that, was monitoring withdrawn branded a on the this year. doesn't in keep the roughly that, CHANTIX, And

I quite disliked that's impressive run what like a vertical. So be with that, think to rate to we've see in product a fairly seen

any to market that. CHANTIX, the coming seen terms haven't in indications we timing In for of terms from new a Pfizer back the of brand

that the moment, terms So brand continues in at in the be if changes market the monitor and off to the future. to of we'll continue here to it see

François Brisebois

the implication on product? Okay. wondering, doing And for the just thoughts your well any I'm of generic

John Bencich

Yeah.

of helps obviously I the going market that size think, it we're we into. – the solidify

I a with being think amount I events again, as we shorter strong differentiation generic of that – of think does see So as the efficacy tailwind, treatment well seeing provide single-digit a a healthy having given course nice of cytisinicline adverse selling there a rates out scripts, option.

market. it continues it I well resonate that, bodes a what very be think to robust will in well

will available One – looks But entering. to are today. we generics monitor only Endo continue far of we is that so that's also further things be to it the for

François Brisebois

the trial, type sickling is contrast maybe the designs the the cell any chance, in for Understood. ORCA wouldn't well VX and as And wouldn't of study and addiction? that reasons VX work of – nicotine any ORCA-VX? e-cigarette then And between terms e-cigarette here there compare any cessation this

John Bencich

Yeah.

action about mechanism receptors if the brain. the So think of we nicotine cytisinicline, specifically just the it's for in targeting

cigarette And we've focused has various a basis so, nicotine forms data seen we on applicability addiction. broad should been of cessation. all have historically think it for on The

tried degree snooze, high addiction. have whether But there. form we've So chewing it's a any it that should there. applicability, we vaping, it tobacco, got confidence haven't works of of But nicotine

from that experiment to segment. if we got efficacy new a again we've that we're about. in So excited And can category run is this perspective, show most and this the the market see

the or in you behind more thanXX market it users. look at users million I US. with plus largest cigarette think segment XX the when million e-cigarette The here e-cigarette is next

continues call So dollars we segment think the and it's the with more there. see be harms time see And a marketing the that out can place points their solution as we tobacco data over grow more that we big looking category We redirect associated more on there. help to as around them e-cigarettes, think and be. this seeing solutions as and to today, do we mentioned folks only a right will for viable coming in we more to quit,

François Brisebois

congrats All right. Thanks, on John, the progress. and

John Bencich

Yes, Frank. thanks,

Operator

Go next from Michael comes And Higgins ahead, our Ladenburg question Michael. Thalmann. from

Michael Higgins

of construction from progress A enrollment Sopharma ORCA-VX's couple development Thanks, on the John well questions suite. as the for taking API efforts. and the your questions, me on of and congrats in the

understand, to you what going that next trying Just have gaining the and here steps that FDA they approval of additionally obligations into supply forward to are the then may guys.

John Bencich

Thanks, Michael. Yes.

terms Sofia, their having an we our tableting a location same we Sopharma a XX-year-old I I specifically suite, think is that think, milestone state-of-the-art API dedicated of their as nice see the forward So in just is the really forward and to for facility as partnership getting a our foot And about computer-controlled facility less product. which NDA in facility is in with submission. best than puts this moving think

So be move for filing, are make an to NDA we with I an efforts FDA inspection. to will continuing of they as to work ready lot there that think sure Sopharma a ahead

as high area clinic next we in second a of data focus in that is drive coming the us together things ORCA-X parallel the year. forward for of quarter so with in And

Michael Higgins

take Just that facility? look share to you that, FDA to a us may the when are follow-up coming able be at to in with with

John Bencich

Yes.

of NDA terms unlikely any the after will In is it on timing, until FDA an makes file. that be business

still a So filing from than NDA out an date. we're anticipated more year

be and to now then, with they're to future Sopharma So continue sure a make between prepared working again, for inspection. we'll

Michael Higgins

Makes sense.

you dual thing. share can Turning as the us of share with not Thanks. us if of how may could to of ORCA-VX. any are been that users What make-ups that sort but age, such have be smoking, duration with you you and enrolled, patients to, many able

John Bencich

one, this for think this Jacobs Dr. over I again. I'll hand to

Cindy Jacobs

Sure.

For be could the dual too complicated. study, no That's users. just one

nicotine versus and their only. in and smoking demographics So their younger XXs. the subjects is in XXs were XXs, vaping the in we're seeing obviously, they're study the were crowd, And cessation, the XXs where most XXs a vaping

So population it younger study. be this will in a

Michael Higgins

Cindy. called text Do the thanks any Do you messages know the if -- anything know patient if you or standardized support? about unique Thanks. the, receiving behavioral or what's

Cindy Jacobs

cessation. Yes. support no Standard, standard there is behavioral for really vaping

in then it lot our leaders key and a our did in the area. a and this smoking PI, took for Nancy So basically opinion we materials of vaping applied Dr. the cessation. with Rigotti We

was elaborate stopping far nicotine meds vaping part text has have We material. the the focusing the that. times as for everyone come messaging no when There So clinics on does for as day, as have that's cessation standardized week study. three taking dependence. But study a every the we're counseling Basically, they texting of that into obviously well. like same on

Michael Higgins

then, That's I on QX can you one. the helpful. renally track trial the we're Still help finish study. QTc last here those? one looking for in to Maybe patient And for up with impaired Phase is

Cindy Jacobs

-- just by the end of we'll be year. We're initiating those this

next sometime will early mid they to completed so, be And year.

Michael Higgins

it. Sounds great. Appreciate Thanks, guys.

John Bencich

Thanks, Michael.

Operator

from Go Vandermosten ahead, our question John. from And comes Zacks. next John

John Vandermosten

younger. wanted I demographics on perhaps can were normal thank to -- And the afternoon other or Jerry, details of us the something good ask the the such makeup on perhaps extend about guys. your else John, them They Hey, is that you. smoker? Any economic than you different patients. give question Cindy, to

Cindy Jacobs

a we more pretty not that they in, Yes, are did as and roughly maybe it's females, coming little males -- see do socioeconomic but collect females in. that came average. any We information

is I our in the XXs. that where ORCA-X think younger probably one XXs XXs, most. said I late and on the about was out stood age the average Like, the

John Vandermosten

shorter, think potential if more or nicotine I way, but in of duration more are on change be have Okay. effective perhaps taking vapers maybe And wondering that are. material comments treatment Does cytisinicline or any that? than may actually you longer enough any a something smokers efficacy the

Cindy Jacobs

nicotine Well, collecting we devices. vaping amount vaping. of many the different their There's in are so

now. So is factor smokers. see they do only right we will correlations if any to have that one stratification information time to whether The difference there at is were

they've as vaping, consumption, do be been far kind the then comparison obviously vapors. They couldn't at their always as in whether have have we previous to they of demographics. be demographics able those nicotine data efficacy but to history smokers, smokers will with Those and were look we

John Vandermosten

cash over enrollment question last now two that what the And final the burn completed Okay. might two on? -- you're is you've the that completed months, for working trials on just next the XX be

John Bencich

Sure. Yes.

mentioned heavy cash year, here earlier the call, as remain On would side as of to ORCA-VX. burn with to the of would this Jerry ORCA-X just as get the things, given that come elevated through wrap those studies as quarter on burn the the in we as the lift middle expect we down, we still start well then And into up expect of XXXX, to the year. fourth

John Vandermosten

you, right. All it. Got Appreciate it. Thank Tom.

Operator

our [Operator Go Global Instructions] And ahead. from next Molloy Partners. from Alliance Jim question comes

Jim Molloy

John. as dynamic you a was finish you characterize partnership bit Thanks of talk Hey, I sort to could closer questions. would getting little here at my taking environment all? if wondering about you're how the Has the for line. the changed

partnership? trigger that approval? your Does in advance guys think you the triggers do the do what FDA playing What think -- with pull How really I someone data, you do in hard after then it's see partnerships. out And to you tell end? know, the

John Bencich

for Yes. question, the Jim. Thanks

the of momentum On we've we'll of side, ORCA-X the side seen partnership kind other say, results. increased some the on

So that more folks been table. encouraging has come the to to see

I think, know. of trigger. in always terms hard It's a to

move and going those put continue the in and over in that be got ORCA-X, metric shoes is yourself hurdle discussions an to to term well sheet. to ORCA-VX go in had along. a You forward the terms what's we of get believe important going as ahead But them moving as to other to with

sets smoking the of indication. cessation of the terms product for stage profile product this obviously, the ORCA-X, final in

that from exist frankly, ORCA-VX doesn't a opportunity into think market expansion a today. I category potential And

in well. have having we terms receptivity strong vaping category move the in ability of forward to heard the So as

see So do quarter I think being to the of important see the we year it's milestones a combination those to that but things expect of second we'll next in discussions.

Jim Molloy

Excellent.

tree API the fact versus you come can the the I that something effort in I synthetically that's on the grow. worth maturity. attempting not to on synthesis eventually create the think just updates or past, from the where get given along Any that current all will think you've it is? discussed

John Bencich

question. Yes. Good

So, of an getting over outside years into the in this that on in this plants to of area we've side, looking terms produce is the synthetic several alternative for looked more ground. past ways the

given nature that's far what proven that's replicated produces. elusive just easily So vitro. not It's something in

to So, on continue continue continue for do looks to not like the look actively we'll we'll it's currently ways but researching for exploring foreseeable focus into. But something other something or to natural future. far, so we look It's that that. sourcing we're solve for to it

Jim Molloy

me. for Thank for final question you And that.

your at as ORCA-X time to bring free coming some half in? or Any out. to makes look at have going XXXX in, else up -- As the things sense here thoughts anything next scientists if to second runs are to least bring

John Bencich

Yes. Good complementary question. we're be We've what on. might at often to looked what working

that for us see expansion we're other at cytisinicline it's assets be outside that be that of cytisinicline. think I you most there's be I But something make could nicotine leveraging across has and successfully, are will horizon vaping the it's And may sense for continue indication moment things the there addictions may addictions. continue progress other if to been into the But think -- the something to to nicotine applicable evaluate. of that other kind seamless could always as complementary. we scanning if that aware,

Jim Molloy

for Thanks Great. taking the questions.

John Bencich

Jim. Thanks,

Operator

I management Thank to now for any time, turn you. like would to closing back at remarks. And it this

John Bencich

in well year. bringing look everyone forth as the joining to Thanks to current on second progress We're about with fully results as trial the ORCA-VX. we operator, in to next of trials us ORCA-X quarter the our continued of and deliver our both excited forward pivotal having milestones continuing today. thanks for And enrolled everyone now

everyone's appreciate to I look further interest. continued in the updates near future. So, forward providing We

Operator

you This you. conference. today's We participation. Thank does your conclude for thank

time wonderful You may at disconnect have this day. your lines a and

Achieve Life Sciences (ACHV) 14 Nov 222022 Q3 Earnings call transcript