Earnings call transcript Q2 2023

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Operator

Greetings. Welcome to the Achieve Life Sciences Second Quarter 2023 Earnings Conference Call and Webcast. At this time all participants’ are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

would Investor hand Relations. I to call time, Jones, Nicole this like the to over At Thank you.

begin. may You

Nicole Jones

Thank you, Officer. the John operator, the and Jerry Q&A President thank you to after Officer; Medical will Today Officer; Cindy and Achieve, be and Executive for Chief call Principal everyone from we management Chief prepared have Accounting remarks. Bencich, Wan, Dr. Jacobs, Achieve’s today. for joining available

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

I'll now turn the call over to John.

John Bencich

everyone this to joined you, Nicole who morning. and us has Thank

XXXX milestones seen to which all in market to in of of our of cytisinicline program first cessation meaningful first-half shareholders. a were value contributed Several take and substantial culmination has step products ambitions smoking the forward. met nearly to to the the bring proximity, The close XX-years

closely Phase a Firstly, and May, benign validated efficacy ORCA-X those effect demonstrated of results the side profile. in ORCA-X X trial with trial and the replicated significant

excellent the the trial to Achieve prior results results, from just Secondly, XXX e-cigarette positive ORCA-VX announced clinical X Phase ORCA-X in users.

terms capital or XXXX. additional published raised JAMA our Thirdly, runway agreement extending study. convertible Medical Association finally, Journal cash the our we Achieve the renegotiated the well loan groundbreaking of American maturity date. of Fourthly, providing And into ORCA-X

the results subjects, health compelling so U.S. look for smoking X completed clinical trials highlight confirmed value the evidence to necessary and cessation. the to progress Overall, the public and in Phase forward fronts. on important, and safety to approval over cytisinicline was significant the X,XXX both continuing in FDA globally. cytisinicline We of cessation made many the pursue cytisinicline of smoking campaign efficacy With underlying combined

approved, cytisinicline and smokers the aiming new first in could to first-half prescription make U.S. of in available two be treatment million if NDA an nearly the submission XX to made decades. the in are We XXXX roughly the

the with focus with with who believe regulatory around of discussions and attention well partnering interested parallel potential In in we commercial the continue globe, supply parties on chain, on as also cytisinicline. the immense readiness activities, as CMC to

now cessation Additionally, market. we ambitions addiction the and nicotine can the our expand beyond smoking broader market into

you in expanding cessation. short the product first-in-class vaping for popularity has the serious nearly a potential are with As to or smoking XX be are market is of products. Americans, are the safety using Combined either emerge vaping currently about long-term concerns target and to continuing these Cytisinicline e-cigarettes. both aware, and who potential million is

duration, by the that or odds on treatment Looking endpoint follow-up, were through participants, trials, data Bupropion ratios over more ratios XX XX% has were XX-week efficacy cessation rates confirming measured been rates in with above what remained to times Chantix, received that to from at exceeded who At specifically X quit, four range primary six the times quit odds times subjects have demonstrated times. the compared to both historically during The the to X NRT. XX% rates XX-week the of the nine cytisinicline placebo. likely with weeks

current scale head-to-head agents. cessation was for reference. any Although we X,XXX we smoking most treatments effects approved trial of results did can The program, conducted trial better not understand our randomized review trial the subject include the EAGLES large previous comparisons in neuropsychiatric of to ORCA recent

available agents. analyses X with This ratios observed the independent X between odds currently is quit and in the XX% population, For which were X.X meta in published odds with XX% XX-weeks the X.X and times to times U.S. rates ratios Cochrane from roughly line by between ranging group, times for times.

has In week duration arm, existing a is our which six ORCA addition, medications. validated the program of treatment half novel

Importantly, this therapy, existing treatments. those observed we course of that exceed ratios odds shorter of even with

are meaningful impact with patients We very with for this in cytisinicline potential setting. a pleased make the to-date and to its efficacy observed

the we observed continues ORCA and authors the tolerability for the profile, excellent. described as of recent program safety to cytisinicline Complementary and the the publication, efficacy JAMA by as shine in to

therapies. As limitation cytisinicline, have a stated an participants to X.X% of Side of discontinued adoption as to event. effects in and the major reported ORCA-X paper only been due compliance adverse existing

outcome. products, of to lack the cytisinicline attempts profile smoking effect We quit the of likelihood and have events. encouraging increase management for effects, in make side attempt compliance of long the Ultimately, a quit and side regimen, relapse. dealt patients adherence the compel as the be to related adverse treatment also believe unsuccessful the The of with leads aid will who well successful using should having to neuropsychiatric of safety as concerns many a prescribers,

the results and of safety e-cigarette the Finishing updates, cytisinicline trial, the ORCA-VX in off clinical announced on XXX efficacy the the quarter we trial for cessation second in evaluating adults. also of

of cytisinicline reported no cessation extremely a well compared pleased participants are XX.X% tolerated related very with treated significant statistically a adverse We serious to at to Again, group. cytisinicline was X.X higher during to times XX.X% trial. placebo vaping, cytisinicline, events rate of for for with benefit quitting the odds treatment the report a compared placebo. Ultimately,

to reporting a which XX% expand survey a make nearly to we plans specifically a rapidly is of million XX users vape in published be the opportunity of there health. this for Unfortunately, XX% endorsed nicotine of future year. unique a growing utilization overall XXXX, cytisinicline public are cessation, over to impact epidemic and why the currently increase Vaping adults treatments In significant daily X,XXX with JAMA in over no believe use quit. prior e-cigarettes, FDA approved to is a continues e-cigarette

our I’ll over time and it highlights At Jerry to review hand results. this to financial

Jerry Wan

John. Thanks,

terms date. the million now Under quarter, Bank. will completed agreement, our and from our $XX.X providing the Valley the maturity by loan outstanding with this pleased previous of a financial Beyond extension raise strengthened successfully loan new on are XX-month outstanding further Silicon proceeds we of clinical progress position full capital the have mature also to XXnd, our XXXX, December with refinancing a loan gross

other and interest repayment regarding conversion unchanged. price remain materially The provisions rates, rate,

our $XX Net $X.X loss loss quarter to period million quarter same year. $XX.X the decreased statement the million for the of to the XXXX, net Turning of of net for a June compared of compared prior the XXth, same XXXX. million in incurred a XXXX operations, months XXth, ended million, six for ended June loss to company as $XX.X to as for the

trials ORCA-X trial, XXXX, NDA ORCA-VX Phase the offset by initiation were trial the trial of the were as for an with anticipate these Operating and to quarter were Phase the lower X in additional due June in expenses ended completed. decline to expenses of the of costs We the NDA X second-half supporting successfully XXXX increase PK renal the XXth, both completion enrollment the of partially associated preparation up impairment study, of ramp activities. operating

balance over XXXX. due direct June to of company's $XX.X provide cash offering, prior sufficient cash XXXX. period cash, $XX.X in into which of XXXX, May in We million, the to The restricted and as cash the was equivalents, quarter. cash our is As prior us increase XXth, to registered our was million current the closed runway the believe compared for second-half

to John. like call back update. my now over turn I'd the to concludes That

John Bencich

Jerry. Thanks,

to cytisinicline small company are lie said, the proud ahead the a of program we employees, shift That recognize fully and our how NDA our prepare of as quite the U.S. accomplishments under we and full-time for forward As challenges towards XX has approval cytisinicline gears advanced look filing far only regulatory direction. we that

The our an agent next in important scheduled will opportunity focus in final regulatory meeting solicit a the for FDA, pre-NDA process NDA submission. fourth occur quarter. the and the advance is and now affords be in to from comments meeting is holding clarification us a the with This which of us to

to submission we We to in the to our timing meeting. hope to pre-NDA hold after an are first-half NDA XXXX and a position be of our submission guide in refine continuing

for believe number We positioned about cytisinicline, opportunity a continue to reasons. we of market excited which uniquely be for the is success for

a in meeting and new alone. There is the FDA the needs are agents in pharmacologic by United treatment no and who XX large and people, currently million patients providers. options that approximately not underserved XX roughly patient the their of or the smoke cigarettes XX-years nearly have been approved people, States e-cigarettes of use available there First, population million who are healthcare

tailwinds robust clinical there to for that political advance of Second, strong significant like are and their ensuring demonstrated cytisinicline. and have treatments safety to efficacy cessation access advocacy evidence help medications smoking

up where broad of prescriber cytisinicline patient with Affordable coverage left currently finally, or pharmaceutical enabling off. cessation addition, And insurance Act share branded In to there the burden. opportunity the pick Care voice are agents competing for ensures no patient Chantix minimal

with modest discount category XX% in a exclusivity, in U.S. virtually losing over U.S. $X generating the Chantix at million annual over billion sales, attributed Before the in to And is market. and with marketing Chantix revenues dominated or $XXX the even global sales growing promotion, priced generic no and

with commercial existing positioned elements these for cytisinicline of rates the and tolerability therapies combined makes challenging All relapse with high seen success. uniquely

is It is and great truly people. exciting lives impact millions on that that clearly has potential of make a has strong clinical to the differentiated such profound product of a to evidence work on

call at updating for us. thank for I’ll support to In forward again all turn progress. our operator the closing, time and questions. over to this for the And joining now your look once you We on you

Operator

Thank you.

be line Street questions. now proceed Flaten come will Instructions] the question-and-answer Our with with [Operator first conducting of Capital. We Please questions Thomas from a Lake your session.

Thomas Flaten

wondering Maybe that's could pre-clinical, bit provide that's helpful. appreciate you going submission? was bit work morning. to detail a the good support ongoing on I taking Hey, you color the John, -- a little if NDA non-clinical more questions. I little guys be the would more

John Bencich

Thomas. thanks Yes,

three ongoing, complete studies. PK final happening got ready impairment front, study of end day, renal expected NDA the really on year on not first-half study, this interval QT clinical in all much as work, are next. a non-clinical as the on be So, times on a X are those trial a is and that's milligrams where by of an remaining submission focusing well that pre-clinical, effort we be to a the of to We've three

Thomas Flaten

some they could preparedness there helpful. for FDA just an they inspection? And you point be color think need would us at Do some you of some level of Are this now? ready Great. time Sopharma’s then give still sense

John Bencich

with there, us. area to So of one NDA. They CMC the a high the of be manufacturers this -- Sopharma our respect the will over be continues in activities to focus record for and

something Sopharma So with But for is inspection. we large This have to as FDA a that FDA with will ensuring to future they EMA. a time of another is respect they continue effort aware, above. we're and been amount to level that be spend ready used all

will probably to into focus we one proceed. this do areas, think we But for ready to the I be we that’ll on So as get we position year of be all believe inspection our crest file. an efforts NDA continue a in next as

Thomas Flaten

then could wise a approval? And sticking just with and submit you you sense of expect get us where as to you be then inventory Sopharma give

John Bencich

inventory, to that continue a building stockpile in we guide a launch. respect advance cytisinicline of With to been of future we've up

end continue into four year. something this XXXX So that We'd to to grow and years this three this of launch well. we'll to that is continue expect the will quantity, of have year as at

Thomas Flaten

questions. Appreciate you. Excellent. taking the Thank

Operator

Thank you.

the with Please line Oppenheimer. proceed from Brisebois of come questions next with Francois questions. your Our

Francois Brisebois

taking for thanks questions. the Hey,

hurdle? standard, anything of PK, in trials before of pretty Or hardest is So nothing the those and there of, renal, in worry the the the this is there to QT submission? really about terms and that's, kind terms

John Bencich

potentially for nothing respect renal These are NDA. in reductions, those derail to thanks any like Bu that. particular that would terms would labeling, three would all really into there's into change profile. overall of product Franc. things go nothing the that With the Yes, the dose things question, in studies,

check studies FDA. clinical So to box for basically these need the are that we

Francois Brisebois

Thank can for Okay, thinking side if any partnerships, share partnerships, the you is terms it in more on you. terms or you're great. or timing, in thoughts share color ex-U.S? And -- these maybe CMC color maybe and of anything studies of can you

John Bencich

Franc. thanks the for Yes, question,

to respect that of to studies I with you are high of mentioned think to any going So potential be partners. these importance commercial partnerships, don't any really

the in now that ongoing from we're So, partners. we're not of going the currently sets core have ORCA-X of that able is in having terms with think data on be how to any We discussions going you're of ORCA-VX, hand we the the ORCA-X, potential to -- commercially in assessment driving of ORCA-X profile to be clinical and factors and product package, viable. terms comment the that

Francois Brisebois

for the one, side, sorry, here this, next just in the we've then if program? now. data last the seen could on I I'm Great. And talk step the about, I Can e-cigarette just that sneak if missed you

John Bencich

thanks, Yes, Franc.

cessation. interim focus vaping working will in study still on for respect report submission to be on NDA study. together continue here, the ORCA-VX the to clinical So the the indication, with We're smoking for our pulling

other the budgeting the powering, the of we'll start On be cessation. like. to work going in be might side what the near-term of of in smoking that on the again, some that, trial is position here NDA to design, a look focus for around But

Francois Brisebois

Thank you.

Operator

you. Thank

Our next question line Ladenburg comes with proceed your Thalmann. with the Michael Higgins of questions. from Please

Farhana Sakloth

of morning. This Michael. Good guys. behalf Hey, Farhana is on

established level framework So acceptable nitrosamine in And generic week saying Endo Pharmaceuticals a last nitrosamine impurity the infringing. last of in assessing that It's drug it team. a also must questions for issued a technique in us, an Zydus tow for protocol. so week, be guidance sued FDA a we're

confident limit? And generic the companies? is so, this the monetize So, you are your of FDA's is can you within manufacturing if something that drug with

is, question doing marketing plan non-often if a budget Thanks. hire market? it when? And executive without the second pharma we you do to experience have And a preferably launch, large one running a a into so, in with

John Bencich

the for question thanks Farhana, Yes, there.

last on million to have Chantix an market. over could controlling new for do going the to for in think see $XXX recent we're violations None that we have IP IP of on did hitting in we there the think the been this sales launch. of that's nitrosamines the respect on side We Zydus we we what's across potential with with the IP to of blocking see going sue Endo around for We respect generic tracking opportunity that doing. north our the formulations of terms space. reads sitting in with So another what others be year

on in final we that So that's working drug and in then limits collaboration as proceed our FDA product. actively with working we're with to background the obviously on nitrosamine something respect

as continue that's an something NDA. that So, through will we proceed

the with rightly question respect of be our with the planned focus, think indicated, that's and that time. moment. at planning to efficient anything best have likely footprint group charge discussions we've that on I investments moment. for a indicated any at or is want in believe launch primary has in that asset continuing hiring as your hands the not So we very commercial. large to to continue We've this pharma of currently is second to on tease as commercial, ahead nimble got you some exec, that before another making we the already this biotech for partnering always out leading a And in so We’ve the those parallel going a make is quite we served in sure care place and discussions

Farhana Sakloth

back in Okay, I’ll jump great. Thank the you. queue.

Operator

Thank you.

come Our questions. with with Partners. questions of line Molloy your next from proceed Please James the Alliance Resource

Laura Suriel

taking Hello. Laura This Thank questions. is Jim in calling for you Molloy. Suriel for the

in arm the higher the XX-week -- the ratio of odds regimen in Are treatment versus, into arm cytisinicline? the treatment odds looking higher final ORCA-X treatment you the our for the of you of treatment data. recent having you know, the specific, six-week know, with XX-week as So -- quitting seen

John Bencich

Yes, thanks Laura. for question, the

with respect treatment. it up commercially, presentation the of to read would think So will to we -- it likely XX-weeks

novel need a go would incremental would the for prescribe little do they in is validated the think course on six If half existing we've of medication. presentation XX-week to they weeks. And with is market. quit, of data from So a that back they products market, built longer six perspective, XX-weeks I what Patient got the the refill of would which duration beauty fill we've physician full weeks we the then cytisinicline. a think to here that of bit and the even

Laura Suriel

trial Thanks then the vaping the also ORCA-VX of for complete, a status clarity. the it. for And potential with Got X cessation? what's trial Phase now on cytisinicline pediatric

John Bencich

likely this road. something down going So is for with vaping, indication pediatric to that's be well to respect a the

going is to vaping five the and what in users, done Our on the cessation lot is be the big Obviously, focus on epidemic monumentally PR the side. adult e-cigarette gotten a over the here to that's interim similar of youth last in smoking we've years.

treat. needs opened think us foremost, that it allowing indication population getting is it be something addressed, we to the So and for is and into as think but first up be to believe marketplace be prescribed do diving that I before on to difficult what we such a will

Laura Suriel

quarter. and Thanks progress on the Got this it. congrats for questions the

John Bencich

Thanks, Laura.

Operator

Thank you.

comes Our proceed the next questions. John Zacks Research. from with line Vandermosten of question your with Please

John Vandermosten

How you and are you morning, Thank doing? John. good

John Bencich

Great.

John Vandermosten

Achieve, I'm of thinking make that other we a know, bunch sense which including you others. might to split does up, number a for particularly New the [Perrigo] team there's because lot Pfizer, have, know, one or bunch partner So and a to potential different one have Australia, Do of Reddy’s sense there multiple whole for that focused (ph), on a make of fully a you in that Is it and our deals, commercializes think if suitors research, and anything you different identified that vaping potentially region. deal attractive things have regions make you have it Zealand, to it there's how's of GSK, or that product? Dr. might may opportunities, cytisinicline that more example,

John Bencich

single partner, the in. have Yes, territories interested for that thanks that respect With capabilities to partner it we're various question, would in John. the around our a the be global ideal all world

for this a been as portion strong said, when Chantix be going launch. given capabilities globally, critical proxy, a of I that think that with looking U.S. revenues at being has U.S. substantial to the such are

tremendous of over that amount Asia interest years. the seen out With a being of we've said,

move specifically them. deals multiple for sheets regions forward seen those We and with in term not have we

single of, for that larger But are said, look around a globe, the can given I over globe. the there you a play there opportunities, the there's think I we like you a kind out So is think transaction. everywhere across need, smokers billion potential

So deals. partner start ordering I global kind think we thinking first that's before we're of multiple about. Single thinking about the

John Vandermosten

approval rate China wait the seems to high efforts thing. do particularly smoking attractive comes before a think as of you because certain well. is or And back good. think a and to well, then there Sounds lot to I to interest suitors, cut pretty that's as potential more making And they're appetite it's a until go pharma’s over

lot recently. And there's how type about wondering, just sense when You based been on big thinking what I'm a of know, risk transact I of, less, your think is pharma kind to on hurdles? regulatory is

John Bencich

Yes.

So pharma, I here we've is in partnerships news last good from over the M&A seen terms of to in as I months. an XX uptick the activity, mean, as willingness, think well six

So encouraging. I think that's

I years. across a there's board, the of that companies that you cliffs think three over two are look when lot next to the coming revenue

So, replace a that is need of there new to some with revenues.

the shapes we well, find that, all of, kind a to So, kind we commercial up as think push partner. of make

John Vandermosten

you in funded maybe rather or have They few perhaps put studies small there And [Indiscernible] any government, and seen seen seem And by a place? something out cytisinicline study a and I've great. head-to-head a there. out just of Okay, measuring but

John Bencich

Australian of as not or aware New that, you're sort large scale got of head-to-head that to are not Yes. outside of ongoing. ongoing the any. trials results, well other of With any we're like the against that, respect aware that study recent studies Zealand study, But Chantix. as We've

John Vandermosten

it. Appreciate John. Thanks, Great.

Operator

you. Thank

question-and-answer John of over would floor our now to comments. the to turn like the for I closing reached have session. We Bencich end back

John Bencich

today. for joining everyone us again Thanks

us our vaping in with of equation, Phase smoking for trial. cessation pivotal as The second and second the getting one critical for and a final through quarter well the very both X side points as data was

as about move to we've updates future look forward Thanks really the we excited joining and made providing So forward to us a for today. submission. NDA progress additional again

Operator

you. This participation. today's teleconference. does Thank appreciate conclude We your

your rest disconnect lines You time. your day. Enjoy may the of at this

Achieve Life Sciences (ACHV) 15 Aug 232023 Q2 Earnings call transcript