Prothena (PRTA) 15 Feb 242023 Q4 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Prothena Biosciences Fourth Quarter and Full Year 2023 Financial Results Conference Call. My name is Krista, and I will be your coordinator for today. [Operator Instructions] I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at Prothena. Please proceed.

Thank you, operator. welcome Quarter call Financial and XXXX guidance. and business review Results everyone, financial Fourth progress Full afternoon, to to today's Prothena's and Good Year XXXX is release is and attached SEC. to filed earlier Please at X-K also we Form with the our website press today, review which today available a on prothena.com issued the

turning Executive today's available Officer, President website, Events Investor addition, are we our our remarks, opening using Stage Chief Garen, Mayo Officer, Chief update amyloidosis. Dr. of will Nguyen, In then provide Kinney, discuss Presentations to will supplemental call, programs. an section. On call including provide and on patients financial and Gene XXXX slides, Chief which Medical closing will our Chief results IV are Dr. a Gene and an Operating up and our our guidance And ongoing in overview is will XXXX on At of session. clinical development Strategy point, Q&A our wholly open our we and update Prothena's our pre-commercial which Tran it with program, Hideki Phase for an for the corporate will III Brandon owned AL back remarks. Officer strategy. Smith, progress Birtamimab for which before for our financial Chief the Officer, Financial provide on treatment Officer,

statements. certain are cause materially to in that presentation, could forward-looking we today's to subject differ during uncertainties will factors I you forward-looking referred Before from remind begin, making statements to to results we that like would and any actual be those that risks other

I'd issued recent as see to Gene. associated the turn call obligation to with We filings our disclaim update statements. With well and as the discussion a press forward-looking our uncertainties that, most forward-looking For statements, our the with to any like SEC. over our risks please today release of

all and and highlights. Mark, thank you financial results today for business our review us XXXX you, joining Thank to

X. Let's on begin Slide

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are market for thoughtfully out building As commercial we look leadership ahead, we and Birtamimab. also insights our

context a the to call will efforts, pre-commercial on over our provide to I now little more Brandon. Brandon? So turn

Gene. Thanks,

to X. Moving Slide

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Thank you, Brandon.

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XX addition, early are for In evaluating separate AX with in we homozygous decors ranging disease Alzheimer's carriers approximately XXX milligrams. XX from with doses to participants

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weeks the open-label from previously the II comparison continues extension Roche, data from the Markers trial, of prasinezumab report PADOVA progression to MDS Part by IIb primary as real-world data months. Roche or meaningful motor disease early motor disease into slowing as [indiscernible] population to double-blind disease. from compared PAS trial, a prasinezumab's This advanced the trial, the expects increase of partner, to endpoint on These the early population by year start cohort. one-to-one clinically assessed quarter XX motor XXX are real-world the the cohort August. at progression Phase with of or progression completed X a [indiscernible] the compared first MDS-UPDRS signs saw for the enrollment ongoing potential XX% of Our Initiative, move Parkinson's X-point prasinezumab Parkinson's receive to it greater reduced a analyzed baseline. XXXX. measured Society placebo. Roche score worsening recently in correlated the Part population timed updates at a science placebo-controlled of function top X with mode meaningful prasinezumab prasinezumab later UPDRS in Phase Improvement scale is trial every patients provide as Participants global placebo progression III, that of including or delaying from and prasinezumab presented effect may be to Congress in measured support as by apatite Roche meaningful in least Parkinson's has X the the debate. Roche from a X-year announced data the the trial part III to continue prasinezumab in evaluating Roche which by year. is progression on MDS-UPDRS on Progression data this XX% propensity the in balance line PPMI. The progression The data to to Scale. in pressure

financial XXXX performance XXXX estimates deposition to XX. potential XXXX. And the being as progressive guidance. over half to for is XXX treatment TTR risk like TTR of completed deposition II double-blind, for a of fatal call amyloid the by in turn rare, in disease abnormal first The in a and Phase of high has ibeticine the early recruitment and signal Tran This depleter organs. Nova amyloid of mortality primary in crude to Tran? prevent first-in-class deposition detection action Novo program to potential is is this at cardiomyopathy. developed Nordisk has acquisition the Doris by ongoing now our due XXX financial to and virology. NNCXXXX and both trial. vital to nonatopic amyloid deposit I'd thought [indiscernible] non-native of clinical MMC deplete further and for ATTR mechanism ATTR on characterized patients discussion circulating progressing This function. Noble is Moving NMC to placebo-controlled protein trial Slide for our antibody a of amyloid

that financial detailed to Thanks, reported favorable Please of results. financial we refer [indiscernible] were to financial our for guidance. results Today, breakdown a our our press XXXX release

wholly mentioned portfolio upside programs. In of wholly BMS-XXXXXX, maintaining during in allows known still our formerly and $XX their million. As to opted owned payments partner for while global Gene of opening BMS our potential partnered secure leverage for owned his full robust remarks, PRXXXX rights strategically XXXX, to programs as us

cash which to net to guidance relative XXXX to $XXX $XXX.X In $XXX $XXX million. Net performance our guidance range activity favorable to was million. used which our had million, range we terms of favorable of of our was investing and in financial was operating loss million $XXX guidance, to $XXX million of million,

had million. of million As restricted $XXX XXXX, cash $XXX in favorable and which guidance equivalents our is December of Prothena cash, XX, to cash,

February of As XX.X approximately Prothena million shares X, ordinary outstanding. had XXXX,

simple to with Additionally, we capital continue a debt. X have structure

Turning to on our XXXX financial XX. guidance Slide

investing expect million to net activities used We XXXX and full in between year our $XXX and be operating million. cash $XXX

restricted net the year activities to milestones. an turn used million, approximately year compensation of noncash Gene is I'll driven million XXXX expense. With estimated represents includes end investing back share-based primarily We net estimated discuss full range. The $XXX of operating expect over to our in $XX the which the cash loss upcoming cash, midpoint $XXX to by an in the cash million call and million with cash, estimated Gene? to of equivalents $XXX which that, and

Tran. Thanks,

trials. protein for new patients impact talented I'd make science their the site families support, to potential who like study XX. ongoing and not real we commitment Protheneans our dysregulation to all families, I'd the we thank for advancing Without a of Slide medicines acknowledge their our in thank to patients, staff impact their clinical to could developing. serve. we're and and elucidate also Moving to like the physicians participate the

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to company. With a We biotechnology are integrated programs capitalized focused and we'll become our Q&A. strive advancing on cash now with robust fully well position open Operator? clinical remain to as call the that, a we commercial

Instructions] line comes Charles the from first of question Duncan Your [Operator Cantor from Fitzgerald.

could a I'll clarity got wondered a cohorts you've in to of X on year I'm on limiting a that. enrolled, going I data in XXXX possibly try -- Gene, on little part be doses. have both enrollment pivotal update patient you in regard of a will you And specifically terms XXXX? Yes. which in bit you lot but could or A ASCENT do this what challenge, provide or patient been a B being to later and that X, later meant with what and to could more wondering the on of what program giving anticipate question sense if you if provide an

Charles. question, appreciate the them. for I Thanks Yes.

ongoing that is becomes respect share with plan think, I this data data line, and obviously, additional an time to to substantive. first, trial, just So we as

question. is in I of this enrollment update Hideki update is in around terms update your plan determine. in address to think PRXXXX, I Hideki? that think various still whether cohorts, we when data on we to timing question give to do year, an update that the can that an on or I plan maybe terms we'll And provide ask of something to

Gene. Thanks, Yes.

very as of Board the a So in of high treatment, level interest The monitoring trail. Phase planned. our center milligrams, XXX to to note lost XX data what notes [indiscernible] in has yes, I clearance proceeding that we're part enrollment's strong been And and

to will this so And explore fully us the sponsor. allow

from line the from comes question of Oppenheimer. Jay next Olson Your

progress. the on congrats

X-month for you And do your about what Will the doses? it learn Can extension? will how steps from 'XX? PRXXXX And high low about that? patients the MAD next question to you another hope switch study. talk on doses open-label to have We impact

Thanks, Obviously, specified maybe duration in with dose or just I the placebo placebo-controlled period, that provide that for speak study X-month little Yes. an level Jay. with Well, the extension about receiving can patients. patients potential bit double-blind, reminder X just Hideki after is a we months administration. that subcutaneous do open-label can And a for start a maybe, by month once their period. you

Yes.

within patient not months, cohort once-monthly is label have saying, extension it's strong we again, each X each receive So placebo allowed excited to will here, placebo about very enroll in controlled, mentioned. and for now where drug. And very subcu you enrollment And people will open [indiscernible] the patients as dose.

course, oncoDynamic of other it. PK receive to and patients months are that of safety tolerability be capturing on the first potential we to But [indiscernible] have continue they up will both course, the to of time XX measurement. will and PRXXXX, go Of which treatment

Your floor comes Evercore line next question D. ISI. Michael from from the of

wanted zero that rates to XX-milligram of between comparable the placebo. and ARIA Just XXX we're dose seeing in on the

off consider are bapinizumab of ARIA to while you IV of optimized was lacanumab/subcu do ARIA higher low And less bapinizumab, rates engineering rates do had similarly subcutaneous versus the given you the IV foresee version. that equal you rates when had its dosage? XXX reconcile this? how compared version? And about XXX So at for How your

Yes.

a question. appreciate got there so you've around the built and in question, the great a lot science, it's I So

in across just these the is biology agents. And dosing as what of ARIA anti-amyloid I that really evidence I certainly, respect how to an alluding relationship plays say, on well, think the of is with a anti-abeta that's it's you I think -- there between you're feel basis case think there is And amyloid into with to little reduction. linear But seeing. a ARIA, exposure almost we're different antibodies. response between the what

making and think bapinuzumab point And I lucenumab. astute those you're a observations. So between are

least explore level the to also that XXX-milligram and we with that bapinuzumab from equivalent to observed dose XX-milligram work, can I bit response need an that was in with as ARIA forward asked piece. think were terms say, the on just meant ask that that as managed the published we of And AEC monthly determining you what comment And is I placebo. literature, to need maybe to was relationship. dose with to consistency look molecule-dependent I mentioned, at there we understand kind be with that attained in that basis just approximately a level. With through of to of what the molecule exposure exposures As lucenumab. It what lesser monthly said, think Hideki a Hideki the question relationship little you we on

Gene. Yes. Thanks,

we're to to XXX to cohorts and remind placebo-controlled the well have as the ability just index dose. up XX-milligram platform you, milligrams, with was And exports a just dose. allows to all So you, that rate remind placebo. these as us enrolled. full dose double-blind sponsor running once a monthly trial. And to are subcu provide reported And therapeutic ARIA That we in as actively again, -- we consistent

Neena Your line Bitritto-Garg Deutsche the next from from of comes question Bank.

so why and about should the could selected dose XXX just about based both and C SAD versus mg the consistent and -- doses. of patients that little and a a the But XXX, was the similar XX B just and talked I kg and on aducanumab. expecting XXX you that C off far, being mg wondering ARIA the activity ARIA also as of tell wondering as true about homozygous? And MAD? talk between with so the the higher on the wondering for the I A if just of technics Cohort differences a bit both Just to kind [indiscernible] was of XX Cohort here. then average bit piggyback XXX heaters both well you're the little if Is about us per can some lot noncarriers for comment in you placebo. discussion know think being I'm selection how as to we you you

again then Mina, start Maybe can I here. question. for in Thanks, Hideki Yes. and jump can the

informing data think we've monthly the is with of a that I drug. we've encouraging of about to seen study. blinded. is data. Obviously, us mentioned, this with informs ARIA that think, additional I'm as just A The question again, we as reminder, what a multiple a XX-milligram once-monthly subcutaneous placebo. What as data first, dose which goes obviously, with the I that consistent reduction obviously, the in respect what cohort cohort, to is cohort rates, indicated the single evidence to dose molecule date, this you the amyloid cohort, XX-milligram which remain what that well into about as And study characterize the said is, understand that ongoing would we've in your cohorts as we from helps referring believe the to

a those So study. are double-blind it -- is placebo-controlled

just I And was levels. the other just think these to ask selection of are being think than that around I dose levels that question I'll that dose explored that as maybe explored the and speak to Hideki study to pace to moving we other are the really encouraging were we indicated. the it's the anticipated conduct in are and had decade an be to dose as forward Hideki? levels that anticipated continuing this say

Yes. Thanks, Gene.

you ARIA subcu administration high placebo to monthly really the volume reduction allowed all the And That's dose the continuing explore rate of best-in-class the remind milligrams. And [indiscernible]. us just [indiscernible] So to I with in consistent to see factor potentially delivery, as of the to you I you, purpose and again, X [indiscernible] the had dose we a be Phase of from mentioned, just did remind full encouraging study [indiscernible] study. is. we're Phase and that and explore

Your line from question Piper Rahimi next from Sandler. of Yasmeen comes the

This is on [indiscernible] for Yas.

the dive ARIA more into of kind Just rates. of details the

ARIA efficacy you're differences We populations? expectations and know does that and that safety capture both How derives sometimes Given rates. this across in homozygous this these your regarding APOEX both enrolling heterozygous.

for thanks the No, Yes. question.

of how just I think is of patient there's second built about population. how ARIA X kind across really of entirety trial in X the around think into I that thinking design. think this the questions we just And terms the we're about

cohort. obviously, let level about specific So we're ARIA. as rates, we me And being our to start patient talk with ARIA

in indicated And X were our We a as rates with I cohort out release in are would to consistent of XX-milligram placebo. what that the think that's January treatment reporting months data ARIA in study we after relative one placebo. phase in

I think carriers, cohorts point the in learning separately, testing AOX we're your that from you're -- the something about making B the is homozygote field.

across village does in we this as develop space. take in to companies, iterate multiple a therapeutics to it So this field continue

to on tend I context We trials, think from each is well a of higher think just I dosing Obviously, studies. for missed dosing. itself that the of to, than learning [indiscernible] population. the start we the entirety not that does studies in ARIA clinical are other, doses the less can ideal cases, to that's become think of are And to We population, efficacy-driven some as or as forward to that's skip optimized that lead rate. lessons side in the lead the clear the in registrational preclinical clinical one want side. And of as portions

the patients. homozygote in the to we I little more context deliberate be [indiscernible] Phase in evaluating chose these study So of a bit

entirety population. a of clinical and the selecting this that bring in that levels of the study when the for dose approaches are we that together patient we're optimized population entirety So back

the Efficacy important the think obviously, on the course, important in think trial think as leading to is of and the and supported respect kind we've the seen levels all burden. safety, the with course, of of seen in perspective. we that's And ARIA of reduction indicated those amyloid with this in that believe relative to to based from variables: best-in-class it's we've just are we it of of from that's continuing to ARIA patient therapeutic we've the an space, planned. about as efficacy; to terms some with but data from then, we perspective. factor, therapeutic an the safety. date, directional where X we convenience And about we molecule not subcu, to once end day, date. It guidance monthly have index. But ARIA being for as take talked convenience; given quite think placebo. of comparable how a a about we our in encouraging index data moving we forward just At we're approach about So in And January, perspective, we've

Leerink the Your of question Partners. Rudy from Li next from line comes

dosing follow-up selection. quick a on Just your

in rationale, helpful. the would to tested and talk trying you can be X, which ASCEND X? maybe the not including was So any better in XX-milligram color safety dose a I'm about ASCEND get

for maybe one. take Yes. Maybe thank can -- you this question. And I the just

have in, obviously, we're of what the amyloid terms both understand but think of index. rates I that relationship response therapeutic milligrams XXX to that us And relationship. reduction, we're interested fulsome pretty comprehensive looking also really is to we ARIA believe understanding is exposure from with of in provides in XX a terms overview for exposure something that that. And of milligrams dose a response that evaluating levels to

that's So it. really defined what

has of think study. high mentioned, I as Hideki level interest a this there's in very already been

number way. opportunity So a a of we've able been in and to favorable include to those we've cohorts cohorts, enroll been also the pretty affording

for the as were So than the had had levels study the first the this saw the think envisioned. previously data, conduct that that we cohort level cohort, would say been I we level was XX-milligram on that, just rationale is in to dose decision that that it. Other these testing I really way dose to the continue preplanned dose

Your next of from the Yee comes Jefferies. question Michael from line

then little range you to thread tie know XX%? dose IV we you listening question. questions case there could of just have to and placebo that ask have the expected X around have the the confidence for exposure Thanks those So I ARIA of whereas area, and drug and today actually those are expected was we placebo, lot go around can XX% in our would type more X a drugs, ARIA so, very consistent that still say when that been would in would you for you of whether arm, drive the ARIA wanted the rates XXX-milligram what together if the and specifically in including to and that. And given you what with Xx you have can there's needle.

around double-blind, where XX-milligram And as the reported we you've were at placebo. question, with the obviously, provides the think, I index as is I dose indicated. mean think are what say, consistent the you we rates, this as Mike. study we placebo-controlled. And I then that's, a therapeutic in from is for range move Thanks think perspective dose ability level, ROE to index and that therapeutic up statement the

that already the XXX-milligram I in dose-level level are dose all has So cohorts think Hideki cohort, fact, mentioned active.

way And all so to we're moving forward relationship and exploring the a response full from XXX. XX ranging exposure

everyone molecule. for think The sense convenience potential here, which which permissive we're of us think again, best-in-class believe X is a in then, explore what reduction for burden. a provides a function really have being molecule the around case the general us, amyloid. range. variables, should about So safety, And the talk index but in that very factor, is that therapeutic the which we'll that is exposure that indicate course, area, with therapeutic on focused to from efficacy, index I the relationship continue we response of I And best-in-class as a the this talking about to patient is the the of perspective safety we really

Citizens from JMP. comes question Jason line next the Butler Your of from

to or just And endpoint? being I envisage product around speak how how gears about we practice? us I clinical question about clinical magnitude guess benefit to think of want about the primary prasinezumab. meaningfulness incorporated then the here Can ask you just you into should do a and switch

Yes. No, the question. thanks for Yes.

what So with shown just already this maybe molecule. just a quick refresh Roche has of

database the published a relative PASADENA ADPD progression will data we've group, showed meeting, XX% the have talking measured least on data X in happened more open-label here the XXX% about your for data slowing and by last year with the II Part now abstract. And they while X-year there, the where than less study. And progression open-label society, importantly, published where as at And And recently, it which MDS-UPDRS X. MDS-UPDRS MDS-UPDRS that of hasn't March, seen activity yet, presentation or occur the the they're scale, abstract PPMI on for than Part X, early the Part matched from the the PPMI daily starting data of demographic to group. that prior So movement less in they fact, PPMI extension disorder showed slowing progression Phase that group. scale a even living, XX%

fully is Roche. Dova this. that per run high is the So Obviously, is being in we're study as large with very enrolled a interested This integrity. study

You've XXX this in a patients randomized X:X basis. got on study,

to excited results. we're see So those

clinical I science, on think strong based on it's data. it's based previous

will the on ultimately I partners and be positioned go-forward path. obviously, aggressive be be between based our data. And the the prior appropriate data Roche about think will at the we thinking conversations as And I regulators. the the think have your will how that is high confidence And set very regulatory Roche they're the to informed And as determined question, that by endpoint obtained. also continued study. way then is ultimately, by this they

time I meaningful. the or on think clinical add terms correlate. of and X-point be endpoints is to to in it right, other clinically to trial scale, increase, also one thing to within They're that itself working endpoint in rosettes captures of the to functional progression event the in greater a which

discussion continued the data look So with year. forward we and this to regulators of later course, the

it more Anna H.C. for Gosh question time X from have comes Wainwright. we and today, And from

get well these respect opinion the program. I think concepts, which to don't of on with very wanted Street just your to So PRXXXX some understands

relative we and how AUC, been to from the with CMAX And think do at respect has comes the subcutaneous when what idea you So occupancy, data your are PRX program. CTAP looking which the lecanumumab on -- development that fractional data?

very think ideas to understand going X So factors development any those with be will to forward? about to PRX how respect helpful

and data into through look removal set and of II you as data anti-Abeta And I response, No, we question, as think important I the Phase talked antibodies Yes. the set, between the the our relevant III dose relationship. those relationship I they're And response macanimab terminus targeting about amino is and And antibodies. what a appreciate question. Phase with aducanumab. see think an it's you exposure plaque and so

and Other of or in That's not an around a aducanumab, that effect. linear. perspective much close to true to with all -- case antibody. of anti-beta more antibodies donanemab an the So every show and from point none And I'd that relationship flat is clearance.

bit ARIA, bit It little molecule to respect it's a more dependent. little is with think a different. I

driven and that is molecules, the effect relationship bit a between to dose event, going be a mechanistically you're a a increase different observing. But clearly as may is I plaque, of molecule, bit there we of you're Although meaning but continue believe within antibodies little that little removing said, And to between relationship being that if difference. said, the there's ARIA between risk different. a

rates. that so And informed be about as what we between and talk characterize that future PRXXXX that level multiple think would more And we we able collect in so think cohort we RE data. And is detail our from I ongoing to level about need specifically for our means PRXXXX. dose update, from to trial we substantive Phase data data we cohort what can exposure by additional better be now dose relationships as

turn Thank to you, is have over remarks. everyone. Officer, it for This now time closing I'll Kinney, Executive Gene all the today. we Chief

further look very much, programs. joining appreciate And interest thank you much all your on Prothena, our us forward updates afternoon. for Have a we to to very on We good operator. want you sharing today. Thank the and I in call

Thank now This you participating disconnect. Good you concludes the day. conference for presentation, and may call. in today's