Prothena (PRTA) 15 Feb 192018 Q4 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Prothena Fourth Quarter and Full-Year 2018 Financial Results Conference Call. [Operator Instructions].

As a reminder, this conference call may be recorded. I would now like to turn the conference over to your host, Ms. Ellen Rose. begin. may you Ma'am,

our SEC. Good is to and today a and the review and prothena.com issued also well financial Valerie. the is Please investor release and at press full-year to X-K our conference Form with results we as as progress, call our today, business to financial afternoon, you, filed guidance. welcome review which everyone, earlier Prothena's XXXX XXXX available Thank attached fourth at quarter website

Speaking to have programs Gene Tripuraneni, Chief call Scientific Officer; on corporate Kinney, and Chief Dr. our Development Officer; Officer. and pipeline today's and XXXX our discuss Zago, Dr. President activities, Radhika Dr. we Chief Executive Wagner our our

Financial quarter review the upcoming the guidance. overview addition, Q&A. results for milestones full financial and Gene Officer, an open will and our Tran will and In Nguyen, XXXX fourth our of and of Chief year XXXX Operating provide financial for then Chief call Officer

I'd Before and projections statements prospects that be under results Prothena's be Private plans of uncertainties expectations, other and Act on known unknown from like Securities to not and differ presentation, Litigation Reform factors. assumptions of during future provision risks, making those constitute statements we forward-looking and prove will harbor today's of are to materially the that statements we begin, accurate, based may XXXX. the may course These that actual regarding estimates, the you to safe and anticipated due remind

forward-looking Form any update to Gene. SEC be well as that, our will the filing associated we XX-Q For recent a as to SEC. release forward-looking press of issued turn with our We statements, our most XX-K over obligation the today, disclaim and And with with call filed see like I'd risks the Form also with the discussion soon our to please statements. the

we by joined members and in forward to team to of this upcoming our discuss you beyond. XXXX afternoon. for goal like drive the our devastating of begin I'd help activities, XXXX to looking our neurological ambitious today on our all patients first call Thank But the specific and diseases. are you, before being with acknowledge and management talking and dedication employees execute thank Ellen, I'm who to our talent about we ability milestones to

During XXXX, significant the key thanking and our for recognizing their our advancing Prothena, several capabilities. Radhika, our positions ongoing want start we new have Prothena welcomed who to members to contributions employees years science. individuals that the strengthen and today I commitment made conversation to through to including by many our

have our we the potential in innovative an year, course to spectrum the domain During are diseases. area ways neuroscience, targets Today, sharpened where with past we applying that we deep a change of in novel of have neurological the expertise focus against expertise.

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I'd our call Now turn our Chief over to about Officer, Scientific talk discovery pipeline. to like to the Wagner? Wagner,

Thank you, Radhika.

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Finally, to program. discovery I'd like proprietary abeta briefly our disclose

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Today year of expenses quarter and part to and to fourth fourth result, in This year $X.X costs In primarily compensation as of expense million, of $X.X of approximately for million these XXXX included of Thanks, same quarter cash consulting the revenue of clinical million costs XXXX loss activities to due and full million for consulting full for XXXX and for year $XX.X full in expenses. program, in year total we and and fourth periods goodbye of of year quarter and totaled XXXX of favorable quarter the for corresponding million of and revenue our total colleagues quarter was G&A and Roche fourth payment was investing Celgene last milestone net compared $XX.X $XX in $XX.X as reported million same fourth our including of the our operating provided quarter our included $X.X X by million was a the program, for in of and million associated trial and of for operations $XX PASADENA compared quarter compared fourth G&A year $XXX quarter and guidance XXXX. to approximately the million with of we compared of XXXX $XX.X expenses, expected no associated we year manufacturing restructuring and million R&D XXXX collaboration. million prasinezumab of $X.X reported year of the driven quarter $XX.X compared for XXXX. XXXX million the activities R&D loss costs the figures and of lower amount and year of the net $XX of net and million million $XX.X reorganized million of XXXX expense expense for fourth XXXX to where the primarily Roche fourth of $XX.X personnel full $X.X compared loss full costs. and reported compensation R&D for totaled lower $XX.X quarter full $X.XX achievement fourth for the of compared million XXXX. fourth was year and for full fourth and million as and fourth million XXXX year lower million as full from full $X.X XXXX. expenses and company's lower quarter and fourth million This NEODXXX XXXX million for fourth program a million last to $X.XX April million guidance the the for with was the with compared discontinuation to as a XXXX. and full a the million of from expenses from restructuring reorganization, $XX NEODXXX million operating million the to cash In non-cash XXXX, decrease $XX.X full XXXX, expenses year in expenses million. $X.X the net was million The for $XX primarily of related offset personnel in and clinical which Included Wagner. year for discontinuation fourth quarter and of the to and study and fourth higher full collaboration $XX.X full and also the million of million million the We as to streamlined full versus burn the the share-based after of lower the was $XX the XXXX than associated XXXX. loss and the Phase initiation year by and million $XXX.X quarter full versus our share $X.XX full updated $X.X non-cash for million primarily favorability million million XXXX, quarter to fourth XXXX with quarter and we discontinuation The year due said $XXX.X periods the decrease XXXX to to full friends. and fourth expenses of year $X.XX $X.X $XXX.X included year quarter and Net of million of of full expense compared with included many of XXXX. per and The the XXXX. for charges of loss In $XX.X quarter prasinezumab. in in by the the the a full the credit G&A of and of share of and of to XXXX. XXXX. of and to revenue were and to expenses decrease fourth and year due quarter the non-cash million and $XX.X as year per compensation a of lower $X.X $X.X XXXX share-based and $XX.X the $XX.X year and for loss NEODXXX $XX.X to million $X.X full compared year and of as net quarter share-based the year for $XXX.X

was to difficult, time. business, this all was take want exhibited recognize this during employees to it for opportunity our of I the While and necessary this that professionalism our

the termination impairment by our lease credit $X.X of million the restructuring asset restructuring and fourth share-based of previously benefits, or full amounts realized corresponding we of year Ireland. $XX.X related for compensation totaled quarter non-cash quarter reported result a the in full an fourth The expense million office XXXX. restructuring, with the XXXX XXXX XXXX was adjustment an employee of $X.X exiting offset fourth year of of that included no in charges fourth XXXX the this part Restructuring charges of of XXXX credit million in for result of in for $X.X and in million the of a of for As share-based year XXXX. quarter non-cash compensation the the in a quarter to of restructuring primarily full credit

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Thanks, Tran.

report. forward to to pipeline and move continued coming we progress we XXXX our look in and in expect beyond, have you we data as forward as to back So

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this questions. open for time, the we'll So call Valerie? at

[Operator Instructions].

Marai Christopher question first of Our comes from Nomura.

oriented I your might quarter the that wondering if a little some presenting. update able us be be bit perhaps information mis-TTR, you give to program, we there PD going was the over you. could PD Thank of that knockdown more comment TTR pharmacodynamic on but readout agents? around I and that knockdown Could other on not maybe you we've levels. versus to data understand type fourth the you're specifically the seen compare data some see you of on that for might contrast

start, as Maybe and Yes. well. jump can Thanks Chris. in you question, the Radhika, can for I

think I yes, Chris. distinction So that important an making, you're it's

bulk I'm our the been of of not forms driven seen we've tetrameric that of by is form of I the TTR is that level. other TTR, total sure least as disorder. be in protein. pathogenesis what the at think or has would form estimations, causing aware measurements most of the disease in can the native the argue anyone field that of signal I'm would the of TTR And tetrameric in words, involved by really imagine, you

it's confirmation, in abnormal disease. re-aggregate think to start an then that to the misfold, actually where pathway on of of the tetramer most monomers destabilization those that I that believe and that's leads part the

does of with tetrameric But then normal is what to distinction mis-TTR TTR. not the thus detect been able assay to our it that the we've of form is that establish are see tends calling blood So through plasma. to what the soluble the mis-forms, different the is i.e. those products it and patients, misfolded circulating to in monomer in specifically particular in far forms that best we're breakdown

is Radhika we'll then respect in the And want as we be to as the to using program, of with selection additional also into uptake, that the how dose in types as those activity will pharmacodynamic pool important multiple a use be about think believe. marketplace this her be have something forward. and and it within move commercial important we changing treated so But approaches understanding and in ways remarks. We patients will with indicated to mis-TTR kind very of it agents clearly year, understanding come well, broader

you expect do Radhika, just maybe little how a program employed we So about in this and what to that's speak bit want the might year?

Sure.

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to the it that wait of key we element. data have with you, forward differential end that's all to see we'll the believe but year actually look Now, until we sharing and the to

So a additional to mis-TTR. may are combination we which of what on also as obtain a they where having our the strategic that an would workstream sets at clinical therapeutics might perspective see with effect, effort PRXXXX working in very study contrast, of we're believe on give looking out for if sort us patients also we And we're samples who call good to any, have clinicians of with those two proceed best data development. how that of

And may. maybe if follow up, quick Okay. I just one

your perhaps is guys two the drug polyneuropathy, well as and line might thoughts Are suppose hear And Obviously look where focus? there's about the you. you commercial a might the the we'd cardiac to most currently Given program I therapy be about bring of Thank at subsets, as opportunity might where running want unknowns terms not how in TTR where applicable. clinical curious be -- different TTR, there? disease then to or your you in asset. your of of stage you

sure. Yes,

is is initial there, X measurements the mis-TTR see need think a to So as the that very levels, think X optimal this on through be I to hope make obviously either whether in combination in In us and we as potentially there in are any around as of very is Clearly think study with to to of I we different important We could PK or standalone informed the by think on the questions the and or tolerability. And the a structured clearly in number I basis part a through, path question. number of decisions silencers about we on that going around first, changes about interested questions both particular, data you be primarily of important, pharmacodynamic terms program a you inform safety, this just think in are stabilizers well. well results, Phase whether that to Phase as assay results. think study X, really date, forward. this because Phase how we

a that I definitive you so now. answer don't can give I know And right

amyloidosis of for know action is the differentiated, a mechanism still is that that thing. where PRXXXX evolving I benefit TTR think the pathway is of in which And we in we believe patients, a landscape clearly to the disease. good influencing pathway leads clearly yet

evaluate also PRXXXX time, future a path standalone doesn't that may like a out at where basis. we from the it So we necessarily but same on combination rule a potential perspective,

Okay, thank you.

question of Jefferies. comes Michael Yee Our from next

[ph] Chicory Kolatchy Yee. for on Michael

the to preclinical TTR as your your early, there little And what amyloidosis hoping work, approach two those some over between Thank a could I of from did know on a in of antibody technologies? based our technology. see on differentiate vitro level do question be side. I clinical well but silencing second perspective, the some from see you low highlighting what great you. Just a you approach guess hope you the marketed to differences may guess as -- that your earlier currently reduction it also currently dose? your in are questions time in to potentially I job of mis-TTR at is here on the

Yes.

questions. important very two So

of stabilizers, endpoints the course Akcea the of was in cardiomyopathy we're appeared more we at now you I before So look interesting. here the -- survival role more But some XX the molecule recent how in timing of when XX actually versus also about neuropathy well a learning obviously, they after as Alnylam of And disease. effects and on lot we of existing the terms look months impact think think very the hereditary when can the in clinical the both terms forms months. I jump of data patients, and measures, Radhika, we functional secondary data maybe untreated starting earlier I think what profile time from as even do in about key the interesting. versus -- quite of of in and separate an to patients. therapies the both think or And some in you tafamidis of particularly have point at are treated some at of and the The placebo

logic those maybe with I at to endpoints severe would design And obviously look question any any the I'd a given those be or ask needs addressing patient might spaces. patients. to relative needs. exercise on a of the of what's the in component what is other spaces start the less pull it to Then in relatively a population. think residual for severe standalone the are focused in whether patient And versus clinical straightforward either some you patients combination those happening can those more The approach need PRXXXX of becomes fill out

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Kennen Our comes Markets. RBC MacKay from next Capital question of

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very Yes, good questions.

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X Phase the focus And of study. so that the was really

same the number, Phase don't exact a patients dopaminergic X-month replacement even was As study time. concomitant remember were reminder, therapy X a doses, those and substantial the a of study, at the I Xb where but on in received number that patients

dose we near higher her dose equivalent alpha-synuclein free the that's of which in encouraged course, the to maximum profile So respect dependent. levels, think was at free those what we complete to and safety a up And of were this encouraging blood reduction dose level with both of which Radhika was alluded so course is that. saw we and alpha-synuclein reduction I time of saw at the to there, levels, XX%, comments, about and of patients by a in

with Phase forms prasinezumab, of we load central a evidenced we the alluded levels and the even for at higher good the different look be preclinical to nervous because thing of system brain had penetration we of with or And to in levels aggregated what X respect feel levels, this, means the other the actually comments higher we disease, was in as its brains of its the that as in the think assessed I where terms that when saw was to we ability preference on encouraging idea, Wagner think I of penetration of occupy think alpha-synuclein mentioned we was percentage assume dose and our Parkinson's the patients levels components studies. we by pathological most alpha-synuclein that levels, basis what about in to pretty in study. the the CSF that are about than

Phase So those X. pulled relevant the we of kind some of are that things of out

you're X.X p so that DAT-SPECT to biomarkers studies. bit your I absolutely probably as about have is in the well number on think are from that I'd level some the a both the point not your is be see Radhika has second a And is little -- been and Roche drug a that part in and question I on difference the that's or see well quite terms think PASADENA in in course to study study I think traditional signal of clinical that biology the to developing of study. the the that's of a detection is both comments, between value. placebo. one a a variables that value our digital talked of industrious employing what as also there study accurate. at X.XX, multiple additional relative do that powered p of to XX% of a is we may two-sided in XX.X% team of just level, endpoints versus her perspective, powered What as as pulling And one-sided detection and see signal of powered think arms either of we

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Jay comes question Oppenheimer. from next Our Olson of

you question. Jay. on it of I for patisiran Hi, the that profile you taking inform tafamidis, might us how know and remind ultimately, Matt data, strategy? be on cell is differentiated could the from for of your clinical this and depending please inotersen, touched how could on PRXXXX but Thanks already, the

Absolutely.

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to So Radhika, cover? do you want

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questions no I'm Kinney like I'd back turn any to closing remark. at call for Gene to time. showing further the this over

thank Prothena, over months, and for much. you to We Valerie, afternoon. Thank very the we our look updates coming all interest joining sharing in your on and you, us all you this Thank appreciate forward programs.

conclude this gentlemen, a your participant you conference. for wonderful today's and have day. Thank and Thank you. Ladies does

disconnect. You all may