Achieve Life Sciences (ACHV) 11 Mar 252024 Q4 Earnings call transcript

Company Profile

Participants

Nicole Jones	executive
Richard A. Stewart	executive
Cindy Jacobs	executive
Jaime Xinos	executive
Mark Oki	executive
Gary Nachman	analyst
Thomas Flaten	analyst
FranÃ§ois Brisebois	analyst
Justin Walsh	analyst
John Vandermosten	analyst
Boris Tolkachev	analyst

Call transcript

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Operator

Greetings, and welcome to the Achieve Life Sciences Fourth Quarter and Year-End 2024 Earnings Call and Webcast. [Operator Instructions].

As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Nicole Jones, Achieve Investor Relations. Thank you.

begin. may You

Nicole Jones

Jaime President Good us operator. joined and Financial remarks. you and Cindy Jerry Q&A thank Finance Chief Commercial Accounting Rich Officer; session Thank for a Officer. From morning, Achieve joining Jacobs, Dr. Officer; today. Management Chief are following Mark Wan, Officer; Chief Officer; Life President for Medical Stewart, you, Executive prepared Vice everyone, Oki, Xinos, Chief and available our Sciences, of by Principal and will we be

reminder, a potential the using will to call Achieve a strategies, goals, results release the replay As the later will and conference regarding Achieve. of prior today the earnings contain beliefs, expectations be certain by this issued operating in visiting Today's available call forward-looking or information future statements, provided website. statements press including

information with affect management no differ that Rich. any estimates, these future today, forth the statements website factors the call filed on SEC. a to, replay. I'll not documents are Although not as on may to statements. Achieve telephonic other company's available concerning these but obligation over with company. Actual accurate or of SEC assumptions could result undertakes our Please and webcast any limited in forward-looking now the Achieve to as filings and Time-sensitive of no are based update factors, of of factors statements the revise set the the or uncertainties as turn projections at refer and the risks, to these may including, results believes guarantees of time materially longer be reasonable projections performance.

Richard A. Stewart

dependence for time end submit great morning. good to as and nearly provide with years next the this of today with for a nicotine and nicotine be for cytisinicline in drug patients expects vaping. the to the dependence and for treatment combat doctors and cessation Achieve desperately the at tool cigarette the at Achieve. needed Cytisinicline new smoking new with of be dependence smoking XX to Nicole, FDA you, will for you for NDA It's Thank nicotine quarter. a will first impact exciting

All established the product are compliance. or There's and to and a new increasing Achieve's have of emphasis This greater nicotine urgency effects the deter acceptance of is providers. Execution expansion being approval. vaping NDA with resources submission crisis quarter importance vaping on successful submission, seen of of successful nicotine that combined and the side lung now grow to rapid risks We're pouches, doctors either cytisinicline patients XXXX mission the an a existing younger while are because perils being and to smoking population. evidence work and to have in health creating health much challenging this as toward of a disease third met, and are solve milestone now we confidence shareholder made become commercial injury the our launch XXXX. the of With are in with proud promoted dependence dedicated effective health dependence of to extremely of momentum less only our bringing public the critical. long-term value. for starting nicotine treatments to well we only planned become care in role each progress and cytisinicline with puts treatments The

stages milestones XXXX, and are that launch. the Looking us development back at key of next driving commercial we've toward hit some

for a of by reached necessary We the the ORCA enrollment FDA requirement step clinical the those a which quick at trial submission and long-term participants the Here's open-label cytisinicline NDA. recap receiving required X safety treatment, of XXX least of exposure months completed of cumulative accomplishments. in was

appointed for team of our Phase our trial. We of the vaping for a to a cessation. extensive We cessation leadership leadership to initiatives. the year today, finally, The included from We we Slaoui Kristen company the We a operational FDA Directors, III indication, towards design Mark and taking completed as for clinical treatment us corporate a commercialization. designation Nancy been meeting bringing a to we strengthened our as transitioning also end commercial cytisinicline Phase of with Pheland future the vaping oversee commercial therapy of Dr. Board and experience and the we've strategy agreement hire received with which breakthrough Oki, CFO, strategy steps readiness bring advanced on efforts. II where our financial one. And are in all

most driving mission, severe of pressing heroin addictive the dependence some yet over By burdening $XXX care is costs annually. comorbidities with drug system nicotine one nicotine most our health a time, of reports, health public of billion the the only and As third underserved and our crises cocaine. is in reminder lives, claiming trailing U.S.

products for multiple each to and will moment. nicotine sink million systems dependence nicotine put been on dependence have a it. no in nicotine Right now, are to XX for dependence the for attempting have for the but market, new more treatment Millions truly the than and including to change effective quit ORCA-OL and details obesity. to that moment need provide decreasing updates on or to way the are is, recognize for stopping the we've their the It condition, nicotine is dependence timing, available nearly they nicotine pivotal submission Cindy. a not fail, treatment rather Yet over change effectively year. There not are with turn delivery lack new To failing. must trial medical company. deal of treatment milestones FDA-approved dependence the on I'll Let our moral in every same being for what all quit reached a in the Americans been excited time GLP-Xs years. tools steps, enhancing next without Instead, inadequate. NDA it the that most with behind XX because accomplished battling it XX of a have power, million and the nicotine left that a about We're options

Cindy Jacobs

Thank you, Rich.

start to this year. tremendous of progress the make momentum into continue goals toward have the We kept and our

major with submission. enrolled the sites XX of team's XXX January, for in our milestone, are ORCA-OL we of filing last trial in stages data and NDA treating fast the a XXX of In trial. requirement, safety critical accomplishing this the requirements one cumulative open-label approaching final preparing We from successfully United the participants cytisinicline across X commitment. In States, underscoring months, NDA. the our subjects the X exposure the meeting We're key trial a for additional reached efficiency submission our with cytisinicline safety a long-term under milestone months, FDA's

the data continue Both during no X-year subjects quarter review at And safety trial, data for during and update concerns NDA cumulative of long-term collect with to to reported that data no we the expect the monitoring cytisinicline second open-label safety submit review period. the Additionally, the we'll the of modifications the open-label on safety XXXX. required safety safety reach in and safety first conduct with in submitted the exposure to we of be committee's reaffirmed excellent adherence the study. data XXX-day least second which standard XXX

and safety begun With finalizing X-month the these database data safety we'll now of into rigorous X-month be various have exposure NDA the completed, for integrating documents. data the our milestones the cumulative we process

NDA conducting them As into audits on we them structure. and quality backbone been placing the documents the have finalized, have

Phase Phase and clinical structure. audited, the been reports For are example, in all III and already Phase study I, backbone have II finalized

file of the of We our summary planned to cessation now as finalizing of attention are summary in the finalizing this to turn treatment process will then documents, bring on remain various confident We important market. efficacy safety in the fully and ability and we our smoking documents.

proposed our we important on treatment vaping Phase treatment II has cytisinicline's our end submitting in this for the cessation. Based indication meeting to a a and to treatment cessation first-in-class vaping study as a for NDA market, design Regarding bringing the FDA vaping expand last e-cigarette cessation to discuss of an of meeting, cytisinicline for December as vaping for Phase potential the or III cessation. agreed requirements on supplemental on treatment had XXXX, advancing

Phase trial, a cessation that ORCA-VX, addition ORCA-VX Specifically, completed acceptable one well-controlled vaping Phase Achieve agreed FDA for in II III trial be would to indication.

agreement overall expansion. would be data label for in received ongoing collected that the safety ORCA-OL exposure adequate the study we the currently being Additionally,

confident of treatment dependent for years. XXXX, within trial We're to financing. cytisinicline track in therapy and and cash vaping on focus reminder, there best-in-class new treatment will XXXX, hasn't XX for be the NDA FDA this a July in our and the for we ORCA-VX III are towards the breakthrough for indication. designation directed be been In first is granted As resources where the that cessation, looking a smoking looking nicotine initiate on ensuring that Phase cessation, smoking to clinical ahead dependence the FDA-approved nearly half cessation

on to the We who to to will a it I'll this commercialization millions of to Jaime continue their over diligently for get to product dependence now for market nicotine. people pass work update. want the end

Jaime Xinos

Thank you, morning, and good everyone. Cindy

critical cytisinicline. make Cindy team advancing with the We develop launch worked and continue great to will serve effectively and cross-functional team efficacy the messaging. effort, product safety critical promotional highlights educational label profile commercial to We've and Beginning with commercial NDA for the of activities including commercial for a as foundation that engagement and This readiness. NDA required the progress is label for closely differentiated both requirements. as future draft her the

completed packaging to the in XPL the and be request process finalized selection for and also for We partner. for review third-party have of submission have the proposal included logistics or our details

and make coming to weeks. sign our in final intent of decision expect the We our letter

commercial on for to submission. So remain the summarize, required the we schedule for activities NDA

readiness and key spend. to foundation ensure launch and on X of effectiveness measurability Our efforts on all centered access priorities: a of built current impact are awareness, availability,

in have agencies deep focus. established strategic health of our with with areas care leading expertise partnerships We

Over availability been to that lead initiating due times our action onboarding priorities, agency access. map refining the partners, road have our key require our and past we high-priority aligned and launch long particularly with immediate quarter, projects

simultaneously advancing we our are are evaluating channel XPL our process, strategy. distribution we As selection

filled, place barriers into to are to Our that ensuring every in access. potential is script mitigate any written script tools objective translates ensure a to

This with to necessary value. future the engaging contracting payers begin we proposition value assess and requirements. cytisinicline providing will how We evidence of the shaping communicate to that includes and pricing support

Our preapproval initiate exchange, entry. ensuring information advance through with payers of goal is smooth a in launch discussions to well market formal

is as Finally, regarding appropriate approach pillar, our launch third awareness ensuring crucial. we

call, a be compelling to high insights launch resonate to and last treatments to activate data-driven our our cessation initially efforts messaging patients where We have volumes on on awareness providers a launch who will prescribing recent refined on patient precisely rely awareness initiatives. who profile high-volume our months, cytisinicline's are actively quit. on will of mentioned have to insight to heavily well health to will audience. to deeper engagements deliver care plan our Likewise, before dedicated meaningful and be further will target available and motivated we alternative to I varenicline providers segmentation we patient with focus these our broader enable and at our prescribers. smoking with In are As focus expand activities awareness currently and prescribers, Narrowing treatments. believe measurable prescribing

an financials. further over details in on exciting to we We of to to health. as have I this busy the epic year months. forward and public approach our launch the progress face turn call coming and sharing I opportunity look now the the incredibly review will change Mark ahead to

Mark Oki

and for commercial long-term particularly to to Jaime. that, as our I'm impressed look continue I'll I our the made, earnings Achieve. progress turn executing the incredible working the goals as with company. team NDA with call value. strategic talented the we to on driving to Since my shareholder a of first joining company update. been team, you, With the I've and forward financial prepare to filing transition has stage Thank join the excited CFO

XXXX. XXXX, XX, on the million, securities runway is the million sufficient December cash to believe up $XX.X cash balance third cash, and XX, our from equivalents current into us We of As quarter were of provide $XX.X marketable company's December XXXX.

for the statement million for December year were $XX.X fourth XX, million, $XX.X million and Net year Turning the to and ended fourth quarter was $XX.X XXXX, XXXX, quarter of $XX.X operations. and respectively. expenses operating December XX, loss ended respectively. Total million, our and

for quarter we management strict executing in turn for on This to As plans our to second now growth for dedicated bringing specifically and commercial submission resources effectively cash advance readiness at to and the maintain market, we our maximize focus are towards strategy, the our back XXXX, allocated value Rick NDA practices. ensures the cytisinicline drive continue our our Thank to call upholding that of objectives, you, end closing sustainable are remarks. shareholders. accomplish over and our to I'll

Richard A. Stewart

thanks and not nicotine efficacy energy. that superiority demonstrated head-to-head to comparisons, although has to and dependence Mark safety and over all of want continued commitment Thank the you, your profile cytisinicline's for Achieve emphasize team treatments. I other

up far In fact, previous market-leading shown profile. better has more product the X.Xx side cytisinicline benign efficacy prescription than to effect with a

planning stage. heard, you've an is As commercial in advanced

caused may be American have X will a result be patients' Cytisinicline patients burden in we're are currently a smokers There have are Cytisinicline with successfully, and and abstinence opportunity to a people so patients. tools. a role Millions to progressive option. new like their give they diseases. tool than confident as number million well out large-scale it save but the product, disease from as the smokers to the than quit. we don't be can greater all help diagnosed for quit into US do quit. in of of by benefit respiratory the direct offers attempt the half quit their Fewer the who excited are or I'd soon COPD About used of have by want smoking to physicians the COPD want highlighting with new effective them reducing most III need Furthermore, the X continue itself suffering, million to a hospitalizations. conditions. than hands clinical every who year. they in tools our and for alleviate progression million reduces They and We dependence of smoke. people cytisinicline be that smokers. COPD who disease as blockbuster forefront in each highlight to get XX% related It XX it of approximately critical and the the of Data has treatment all as cytisinicline nicotine also need evidence breakthrough treatment treatment non-COPD of half XX% potent show exacerbations and as a COPD smoke than Cytisinicline COPD of smokers comorbidities improve smoking. market. attempt and trials crucial Americans possible higher disease. to on patients diagnosed make to deter COPD at a symptoms rate year. Over potential, this own experienced lives, that the other to a such in More help can of XX need near-term Phase is patients COPD this to

cytisinicline Looking dependence at ahead nicotine track next XXXX, to and as NDA energized for of we remain the on submission treatment focused, smoking cessation to file for end our first quarter. a

submission, we authorization. marketing forward to acceptance and securing anticipate Following look

and their this that ultimately that to proud While shareholders cytisinicline get addiction. focused unburden extremely quit. Bringing patients to our moves desperately to themselves want readiness launch nothing want hands market this who to I'm health of and to product and long-term of improve the than value dedicated team the patients ready into forward, help those will are more deliver from

dependence public for months. turn or partner. your and and in leading addressing their am As is for to we health also our for effective you strategic you expressed have operator support believe management to the the They forward shareholders of who our a progress questions. crisis time now a coming company. the updating We company, cash goal grateful our the without the I with over appreciate commented, look I'll nicotine for priority on Mark today, in strong

Operator

Our Raymond question of Nachman James. comes Instructions] from line [Operator first Gary the with

Gary Nachman

all on progress. Congrats the

way standpoint, from do help with up the FDA of the product filed a cessation first, anything to And is at I hired manufacturing done clarify to have that then you still specific more that the bit And any given is you made, side? feel requiring buttoned a so you help what the just the XQ, to be for NDA? couple And should of needs the there smoking is the regarding So submission. on prior CMC NDA end be have a the follow-ups. prep external

Richard A. Stewart

Gary. I'll off, kick Right.

team of the the submitted. that I to absolutely hand resources focus on going ensuring and key can. execution Cindy. I'm it are as think and an to really as case. to getting of the is absolute quality the in this good counts job It's terms here her that making possibly the is NDA the But Cindy in fantastic efforts that's sure doing over And the devoting NDA

Cindy Jacobs

CMC all It's FDA Yes. And will finalizing the The the for standard much as safety. efficacy, and what almost wants. sections I stated, unusual actually are routine regimen documents in our this attention we're NDA. documents NDA. summary of to done. we for There's the nothing It's turning be pretty then summary

with It's And experts, accuracy outside has and done consultants that very quality been as other well a this all so lot best documents. This They've consultants, Have best just something we that's always of far And is of been together. it's before. Yes. actually assistance year. of it, checking as try to work, end And coming have focus at the a of the and us very, our lot this we the of successful been that where a at the with the lot quality. vendors? all for then helping on important. as they've pick had last is

Gary Nachman

cytisinicline. the have your to for you help And step so edits be that treatment? through, side, specialty to And That be you're Do chance patients expect ensure the will of that on be refills X helpful. get that? commercial months initial might have are be the pharmacy full their using color they you you That line? have prepare Great. also just but what first then sorting also, something thoughts will Or PA to as in a is good generics? there'll Okay. you place access or a on

Jaime Xinos

that Jamie. question. it's Gary, I'll take Yes.

work first of all, So backwards.

strategy in distribution our channel at looking as are I now, the We mentioned remarks.

have calling want be specialty tier. I because that itself filled a any kind will imposed the and that being And be to well and color and what definitely specialty obviously in may of pharmacy able on track price plans at scripts being in wouldn't are now pharmacy further access considering a make is future, sure mitigate to launch we are the of poised, we light to specialty to that pharmacy full those. are of We because think we're specialty that that pharmacy consider have instead those the but barriers we place of monitor and product written the in specialty

question, Regarding know, to your and going eventually us contracting where on payers come other it's to put strategy it's hard and down their formulary. to

with may So a we us that is when we it XX% of our barriers using rebates I forecasting. are people of estimates I'm use can type we number channel our and conservative correct they of around had only on of me access. specialty put pretty we're wrong, have will But to a the mitigate it some that help trials, to for as in don't think if where simply come preparing I patients it. Cindy light reality varenicline and and out tried want mentioned, is in but was saw And failed doing used? to the Again, either those or we previously

Cindy Jacobs

smoke. to journey Ever try in their to

Jaime Xinos

even and look resistance have And utilize these attempts will, we're are that quitters, the made in when the you we past, multiple varenicline, refuse higher at data. and an quit to still they heavily claims seeing experienced if

use require medical edits products, and implement patients patients just to step use periods the medication. through can around refusal that but those and I get look-back ways also think to to exceptions there's So you

our we're So looking strategy. those at all as we're certainly developing access

Gary Nachman

partnerships any help you vaping could other of that in then funding indication there study? think a at with question III. you, potential and that you that we closer start comorbid non-dilutive Great. might running Okay. for about cytisinicline Phase just for are Rick. getting with and And accelerate potential put And Are a the could that last partner looking to place maybe the then

any of you find scheduled way Now if forward that's next of moved be that, source funding? the Is you for that a could there first think half potentially year.

Richard A. Stewart

Gary, in there. multiple questions

we're of start perhaps in we But be that cytisinicline I year, interested think more that will attention on is some it's patients of The purely at I'll the the got COPD the the right in impact getting certainly focus about resource bound something NDA now, is given parties. later submitted. on saying beginning. but

we be But towards future. think announcing cytisinicline our the anything in bigger I So And we that better overall are of interest our increasing have terms in I on But of wouldn't of a expect preference us is leverage terms act shareholders. we might merits. its the the at is the the to regard of transaction the is driving comes along, near we we the that that it I gain if picture to end gives with in discussions that that have think have a in day, the confidence launch ourselves. evaluate opportunity, And whatever that on as to the partner. something of

Operator

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

Thomas Flaten

to Cindy, are we might so, DSMC And expect when reviews there coming? if results of those? the see future

Cindy Jacobs

safety. You're open-label for the talking about

Thomas Flaten

Yes.

Cindy Jacobs

Yes. We'll reviewing, and probably be scheduled, probably more X-year be one the the be probably obviously, data. that And longer-term think about would last would one. I to safety that have

Thomas Flaten

going feel around there? there's an like and kind up this inspection think they're of with in mock do successfully work question still you done to point? you the Excellent. following at would How are reviews And Do Or then good FDA on shape Sopharma? CMC. be the pass pretty

Richard A. Stewart

frankly, as we brought NDA whole there the said, consultants the activity, is. Cindy us look ensuring is No, external the board, NDA possible assist the that as quality to we across highest with Yes. in

quality the all simple the that to that I question, resources need is So we're to think we Thomas, of NDA. answer the using ensure the

Thomas Flaten

starting expect quick Or onetime some in was quarter Do this there, one-timers you G&A into a were good place is that for quarter, in going that? think quarter, number something substantially, Last of to past or Mark. Got sorry. the $X.X was nature this million there XXXX? but kind be same a pretty up the I then in but it. And one there

Mark Oki

costs but No, that starting and good obviously will manage point. hope starting our the we a the number down bit, consider bring that's to a We point.

Operator

with Our of the Oppenheimer next Company. Brisebois line & question FranÃ§ois comes from

FranÃ§ois Brisebois

Just here. a couple

on terms you we In to 'XX. quarter the this how us just little Or help bit expect mentioned color have discussed? I go? that ramp or And little kind understand, sales I about have try in And help can way. You should Is should the XX-XX? going Is you a partner expect this -- of just any this segmentation on we here? a you figure more third not? partnership a of this launch us talked ramp, either size out to you think can help a of to a color out follow-up. market

Jaime Xinos

questions I start of the regarding ramp. couple Sure. with the will first

So of time we're gate. do as forecasting out to because this anticipate really super initially ramp to get -- but disclosing we expecting slow as point access our and assumptions a far the move this potential, so awareness revenue takes quickly we're it at not not and

the that question. of first your I was think part

was... The Sorry, can you repeat were X... second? the There ramp

FranÃ§ois Brisebois

Yes.

Just I on color any guess, maybe partnership availability.

You the affecting know without. with talked going awareness about discussions it a partner, at ramp. I there's about been and

preference talked about? give little doctors more on any these that If segmentation a you could on color that of the bit you and

Jaime Xinos

work that lot both can But on physician partnership take and the the hand over then I'll done of on question segmentation, segmentation, I the is a to Okay. we've the patients the Rick. side.

those deciles. in top know these are really we So that scripts concentrated varenicline

we've XXX,XXX of those to U.S., of about there's physicians it that treatments smoking who writing XX% about are but in down about XX% narrowed the are So varenicline. cessation writing

we're going motivated the to quitters treatments And who take at think these when highly high-volume look I product. so them ready I then after initial past, mentioned who will the patient be And segmentation on quit. adopt our side, again, help the to really, those at we in are most prescription the as prescribers willing likely efforts and looking physician are to to

-- convinced need through we've and people plans, quit after they talk to and that our with willing going market research the need and are actively And Chantix who option. to at they looked that in this another so it's also them, is just engaging what and we've help physicians their when seen conversations are really launch

And So we that that our narrows motivated. looking segmentation recently we've even further. completed it down just narrow across medical claims highly XX% then general of consumer it work down to behavior, at that can and about

to launch. So And clear how partnering. a we'll patients have at time very with Rick I'll handle these engage of plan let of the

Richard A. Stewart

the know think really key we I getting it condition. this getting the the strategic I of right the medical of place. is I part to thoughts to away NDA the partnering now and execution message a all in Frank, dependence Right, And is right, -- our to said think is is preparation, through nicotine fact emphasize everything that

think thought behalf willpower I isn't. a that the of on this generally has is But of market that patients. it lack

to be I as after cocaine. And therefore, As needs in kind I heroin treated strategy, to said in substance addictive And see discussion of such. about the call, nicotine is reported think that it future at be our the that look we is you'll it nicotine to that most actually we third the the COPD. medical to attitude at created. GLP-Xs really areas, the is start we a obesity condition. closely change And quite in mentioned, reinforcing But message look as do other and that dependence

as that's So a saying we're long-winded the NDA really way of is, focused submitted. that getting on

submission, laser-focused somebody on U.S. opportunity. commercialization rest the else. extremely partner I a we're on the world looking globally. But revenue market of course, strategic out. the U.S. the well that, We laser-focused of actually can somebody, also potential opportunity NDA optimized the an absolutely whilst And pretty But think for represents we're are significant revenue a perhaps which for have and in who thought a we alongside plan, is exploit

FranÃ§ois Brisebois

lastly, just maybe, Mark, position, then go Okay. And Great. financial can of us you in terms through. help the

you there you count? shares, are stuff. the And is do how but warrants you share warrants? have remind get a of So to and lot diluted million can pre-funded us, been what there's just fully XX Just And that?

Mark Oki

We'll Yes. -- kind of you. you broken and a firm I'll options number with to down over give that warrants. it's get

number. can fuller you way just that a one picture have So than rather

FranÃ§ois Brisebois

in fully -- ballpark XX-K are mostly I of talking $XX to extra already, $XX the an like million get that's to And or... million, kind right? Understood. of mean, So we diluted

Mark Oki

to it's No, $XX million. closer another

Operator

next Our Jones from Walsh Justin comes of the Trading. with question line

Justin Walsh

the and/or both seem most condition to that mentioned you any varenicline the initial highlighting what Can target conversion, will converting that color a mentioned nicotine You dependence on that options. from launch will effective in sense, would actually to data believe as but apply provide triggering be to high-volume cystisinicline. medical you providers make does just narrative you the drug

Jaime Xinos

Yes.

question, anecdotally I think of one kind the for thanks Justin. -- -- of the

I that think things product a heard anecdotally, our successful. the leaders it have would we've could we us that that opinion wildly this and from Chantix, gives named kind of one is laugh not be key of

so their I that is years there's here physicians to new XX and huge thing been help in need new them options patients. the help that think nothing And

And we're got so of our when about talking product. we're how evidence we're we've looking the from compliance to this solid going the at efficacy, the the market, position drug and in label profile, the both tolerability

going you nicely packaged different. and And add And to like something? it's would and something really to compelling be very that's so Rick,

Richard A. Stewart

today, XX-odd least yet, use that fact, much and patients a And of the and this, to for Yes. more is particular, uniformly tried quick. treatment response the exemplar pack quit experience clinical years. a at cytisinicline got in X from positive. the the than she's successfully in a today smoking was No, of we who we've even was one if kind ever the I from cigarettes she's And patient Phase who trials smoking only pretty can add XXx. been III as She

reputational. because Phase And the patients stead in feedback in think So that going the what that And think I cytisinicline. and is I from that you the think actually on we can benefit can really like forward. good that, we reputation we build that I it's got find stands really IIIs, X that

Justin Walsh

Great. question more One me. for

or can I'm You place, easier line. plant guys extend manufacture. your harder just through are the cytisinicline have is into we that to on drug period make curious for Acknowledging would if for if down in generics the expect exclusivity expected barriers be I'm from wondering for to a XXXXs. these enter market that you being and comment noted could if extraction others to the there it derived anticipated the potential

Richard A. Stewart

beyond it. a -- a estate extract over a talking to you material. about. that's to I kind But had while if of And to IP we're a I of it It volumes on we've mind it around I the out the think key source top is you maturity. in these itself. question. takes The starting is discussion years, actually barrier easy And the to going our isn't in And think as actual think reach the that great be the that it that pretty plants for to XXXX. say, layer comprehensive takes entry of

I really strongly think favor. combination of does in our factors play very that

Operator

line from comes question the Rodman Brandon with of Folkes next Our [indiscernible]

Unknown Analyst

an :Congratulations follow just to all want up I on the on earlier do question. progress.

prescribers are and been drug, I your at these think any these it high using may the But in high satisfaction of this named varenicline. Chantix. how of have answer sort Hearing have prior prescribers the patients you not on satisfied question. of could terms color

Just there high that these your change need prescribing so given high think in education much nothing because change just been will for usage, differentiation product How you prescribers do ingrained given habit many the for that there years? and much you hasn't very to really understand is else? the is

Jaime Xinos

Yes.

that of for So the -- Brandon. some thanks the work question,

we've low side, rate the they've a reported done relatively of physician work the satisfaction on that Chantix. with Some

ultimately it's data patients In failed think the head, was about the our that fact, the recall product, if my I prescribed they top from X/X their yet off product of utilize. it I most of

landscape product but that using. that's just options, in what a use it's other light having doesn't rather unique a to not work, of treatment so they're you where continue any And

and transfer conversion based they bupropion to an varenicline, of think in and our as far as the got that's prescribers majority NRT to over conversions, rates be only something our I asking efficacy with going of And prescriptions. to initial safety converted are what very receptive them not cytisinicline research, excellent but would their well. analysis a patients we that over of So on did some from them they profile. And as profile,

think having forecast. a in something of of interest and something kind marketplace. likelihood conservative the I new works great having So into numbers of more baked on But basis our much an a that we've some in there's those

Richard A. Stewart

goes this add, heart Brandon, the our can If to of I very commercialization strategy.

commercialization certainly And say we vital to interest. have on soon from think cytisinicline a and absolutely really physicians of strategy clearly there's we a that we success. community. really as on it's quitter where question the should already, the of pent-up And community. to of of a digital-first founded demand capitalize can and interest The for awareness strategy starting level And increasing as both the is So commercial launch, that is we're benefits how. the the patients I I awareness think in -- the see

Unknown Analyst

Great. one I follow-up, may. if And

I much a you just of different given digital there. a commercial is population? first how vaping, heard Just approach younger mention it's

So is understand vaping I'd the jumping the commercial not sort how but different just approach ahead here, on just commercial to approach? far of is or love similar how too

Jaime Xinos

the So prescribers very to perspective, that's lot perhaps apps with I those and is From physician similar unique primary conversations doctors, commercial have from partnership in are engage audience. who prescriber more care same to even or key wearables. consumer, the opportunities going a have we're the a care think in the physicians where that to approach primary

number younger when you're And in space to tech the could be population engaging interesting social really audiences, they're that engaging you social frequently and So also how how the not social for the but activities, population, more, of the and mentioned. of that the younger say as utilization you see that smoking also, really they're expanding channels utilizing. digital isn't

So it's nuanced. certainly

Operator

with Zacks of SCR. the line Our Vandermosten question from next John comes

John Vandermosten

as of They XX% smoking that at out of after. how the in article during and One couple ineffective pregnancy during articles and came thought was about a relevant was these and might interesting a high how another I pregnancy wondered controlling that on almost vaping high. found now there or guess I'd smoking. that it mean, are assume hear to coming out the it forward, you thoughts your really X impact if anyone's thought move these the love on just we because really any don't your really especially had were X% people pregnancy I I or items rate And at looking you all last strategy are developing And thoughts Jamal I then side your that. smoke. was that. pursued in of think I didn't least was was so. rate on commercialization There week

Cindy Jacobs

we a studies have it We to as issue. have show as pregnancy. far with pregnancy, any actual human certainly cytisinicline isn't animal far As do safety [tox] that don't as data

that natural is option patients obviously is it area obviously definitely physicians to an actually and So is the patients, a it might of kind that regard. that view that important for pregnant that consider the in so

Jaime Xinos

interesting primary One John, audience, planning OB/GYN a lot the about are are as Thanks but pregnancy. for visiting our of as who question, prescribers on talked there care point key that. their we've women

And opportunity into to market process. so family that us their in cessation that would be to and start unique should start expansion help early that with a tapping why broader people audience for planning they

surprising. regarding I vaping horizon. So to us, then it being for certainly expands smoking cessation, And about not question the think really your longer opportunity that's over the effective

most then what both. quit ended started years. a I think research, did And they and we people, doing they vaping journey they on indicated vaping many go to when that this was people smoking our over up is

and indoors working, who XX/X have they're vaping. smoking consuming then they're users because when they're essentially they're So dual you nicotine are when not vaping

to interested that And be themselves quit, dependence audience both. and know from they're we're it's commented combination Rick unburdening nicotine ready financial of people think to get know who our off an focus. call. whether a of we this or or to our But as they're really in health during there, altogether, and they're I out we that's So looking are of at looking going

Richard A. Stewart

also this smoking cessation. this include something, the dependency. started got method cessation like yet We whack-a-mole. journey now in another to is of the I've If past we've and now commented with migrated I presenting add -- John. patches nicotine tobacco can It that vaping another

expanding of dependence. And those interplays So think is that reinforces really of that in I front nicotine eyes. our this one each

So dependence. we a think all that actually help on that opportunity drug aware fronts and have that patients we're expanding, is the nicotine these their I with can

John Vandermosten

same who tried they referenced, actually study stop UCSD I that said, to you and that And actually thing vaping found both the nicotine. consuming is more that that up doing with Right. people ended Jamie,

Or producing be now anticipation assume, they're for is for of Second affect supply I make start of the Sopharma. start question schedule product will think for manufacturing now commercialization? the I the to guess U.S. will because will on I manufacturing at exclusive approval that given? the the is in that or the they just How or they it? kind Will is after prepare they ramp-up market, they dosing different. that preparing that when

Richard A. Stewart

Yes.

key time. us I ensure in think right got whole situation the we've NDA is terms to the of to preparation to the right resources the that at submission the available

us the planning ensure we're external we're bringing assist to So actually that board. consultants to said, Cindy across as in

resources manufacturing exactly available products got prioritizing that as same. the the concerned, far the that as need So that launch. I consultants, we're and area in we've brought We is is at think make we to sure

John Vandermosten

Okay.

then thing. And last Okay. one just

the clue that Is that out? not what will you it be name when us gave will Chantix. not clue it to of name? kind on brand be not -- a -- any it that You determining might progress roll be in But

Cindy Jacobs

Yes. have approval actually approval name a We conditional or pre-conditional from on FDA.

at time in to We fashion, change are that's FDA's true this final because approval. subject not that sharing upon

researched with but by as some no, brand started identity various on the logo. of and has FDA. required are that -- including working eligibility our cleared analyses aspects and moved a So we've things of all pronounceability well, we've that name forward through of And brand been and the

exciting this time making is really definitely and we're progress, for a So us.

Operator

morning this with Tolkachev Broker. comes the Freedom line final Our of from Boris question

Boris Tolkachev

regarding have I one study. vaping the future a quick

size possible, Phase the such wondering share, views and were also questions by trial, Given effect meeting. study? whether the you during was the effect could observed And III in Phase end your briefly of raised if future relatively high in placebo FDA the the for the II I expectations ORCA-VX

Cindy Jacobs

and higher Sure. sample rates that And cessation powered definitely And and was ORCA-VX for years placebo conducted valuable able smoking the is most sizing. placebo for that's were higher assess rates to where were at seen Phase the XX study III when being trial trials the being ago. look

expected of kind it higher. we -- that be didn't slightly we So would

accommodate arms a Certainly, a that. to little as underpowered. study then company, as in the to be size a do III that's So higher you sample are able run the number not Phase

little at than power XXX So subjects, that's still addiction with have really vaping, we now greater at looking maybe to estimated we're regimen the placebo trial at because only higher be the going that, view regimen. about XX% looking a at XX-week right what for of as we a with and

where subjects higher definitely for that those rate. to XXX each So accommodate is placebo arms of that's powered

Operator

session. that to turn concludes floor Stewart question-and-answer comments. the I'll final Mr. for any our back gentlemen, and Ladies

Richard A. Stewart

be I'd your only nicotine like our continuing for our mission. critical dependence. thank And to The terms the opportunity Well, quarter in for patients all you interest going submission is is creation to just and a getting NDA value of ability in Achieve bigger next to event. treat

dedication the commitment all excited, is us just their So and to today where we're go. board, and company I to across -- we're for are the getting to the about want where thank we and employees to

much. very you thank So

Operator

Thank conference concludes call. today's you. This

at your lines Thank you time. this participation. You for may disconnect your

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