NERV - Earnings call transcript Q3 2020 | Minerva Neurosciences, Inc.

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Operator

Welcome to the Minerva Neurosciences Third Quarter 2020 Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session, following today's prepared remarks. This call is being webcast live on the Investors section of Minerva's website at ir.minervaneurosciences.com.

As a reminder, today's call is being recorded. to of call Communications Investor like Boni, to at now President Vice Relations would turn over the William Minerva. I and Corporate proceed. Please

William Boni

morning. Investors A.M. Eastern quarter today, company's and business with found press our Time became financial on website. be the highlights X:XX results and of Good third at available can A section release XXXX the

at also morning, Our quarterly the www.sec.gov. Commission the this and Securities be with SEC's report on website filed Form and electronically XX-Q on can was found Exchange

the Mr. Joining Minerva Chief Dr. Executive on Business from me call Chief are Chief President, Remy today and Officer. Chairman Executive Vice Financial and Luthringer, Geoff Executive Officer, Officer; and Race,

the Following for Q&A. our remarks prepared will open call we

reflect or today's these obligation include subject over to XXXX uncertainties disclaims current due September expectations that of statements speak including circumstances indicated. variety forward-looking detailed and made X, caution under differ under that ended the X, the call expectations, filed as SEC report these I plans, company forward-looking are this that a our the of on only Luthringer. XXXX Harbor These the quarterly Litigation our future like constitute statements by Reform on call turn to November SEC, those about we fully I Form factors Act Any required XXXX. you to Before begin, will forward-looking as from except any would Monday, today's more after filings Factors on for XXXX. law. actual based company's to prospects in the caption materially statements for like on would quarter risks Private are to update Securities XX, provisions Risk forward-looking with from of date Safe Remy cause We the statements that with forward-looking occur XX-Q any discussion the of actual purposes events statements the of remind that that and to materially call our and to are statements differ now to November results results the may and may today's

Remy Luthringer

Thank doing everyone. morning joining everyone you, well. good Thanks us. I is hope Bill and for

our the meeting remain lives schizophrenia. of of product, November roluperidone our we on the believe with XX, have on approach we the enthusiastic with significant FDA potential As and it will by impact patients lead

Our compound. confidence this our is and on to the based database date clinical experience compiled with

a early trial the X as that Results functional translated possible line symptoms primary with are top well there generally the the not We negative motivated of patients this was for Phase bring study its need We physicians. treatment with obtained also for achieve comparable mg May. beneficial demonstrated profile into objective. improvements. on a tolerated effect our onset families dose study patients the is with did in for in Also to which of roluperidone leading safety to remains as XX quickly placebo. XX-week negative the symptoms Roluperidone the as double-blind, the part no announced unmet approved to currently of treating and results disease,

of completed shows our from trials extensive from Phase X others, between announcement, dose Xb analysis Phase analysis that and have data including roluperidone of significant placebo. an Following trial we that integrated data this two the separation and and of highly

November we phase amount XX. to large provided trial, In findings of is label on from scheduled the first quarter this the in In data complete FDA late XX-week C of open of in September, meeting preparation addition, the these XXXX. which we now for have to a Type schedule the for

regulatory to and FDA next potential development approval feedback will findings steps the about be receive with the expect the the in the During discussed our forthcoming of and meeting, roluperidone. we agency's

accumulated our all of summary, once the combined update FDA with provide been meeting recent data, an December. which the in now the update. it for minutes data few will In treatment X over by belief a have patients. our become of important can is last Phase the Geoff will turn I further the schizophrenia expected over for to years, support the finalized We that roluperidone continue financial to

Geoff Race

on Thank filed you, may Cash, ended cash more for the morning Remy. Earlier equivalents release SEC our with results discussion quarterly XXXX. as earlier million. we $XX.X restricted third September were approximately issued operating be A XX, press XXXX in a our our the of detailed quarter XX, of this results Form reports XX-Q summarizing and cash today. found September

expenses of lower R&D completion for X MIN-XXX and fees to months months million the $XX.X our we that the three reflects based company's roluperidone are the routinely is R&D sufficient XXXX trial operating capital meet clinical in based we requirements be change. September ended development the upon million $XX.X of in may period the $XX.X into for existing compared $X.X $X.X early million its will which Xb December offering subject be current and expenses the Phase same Phase public the expenses nine XXXX. were equivalents clinical of for XXXX in anticipated to million nine September assumptions The plan. this XX, from estimate of decreases on and and evaluated raised ended stock XXXX XXXX. XX, in cash and primarily to trial presently and cash expect of During the therefore million respectively, net and The

X of compared and the $X.X the million in expect for the were or have $XX.X XXXX periods expenses million due clinical We million G&A $X.X and three portion to decrease primarily the the for and expenses clinical same September G&A to and XX, respectively, we during nine-month the the million expenses XXXX nine in decrease lower three XXXX as completed a loss MIN-XXX net The of months in ended diluted expenses. R&D million of expenses XX, three the diluted was the $XX roluperidone. compared was $XX.X September of commercial and share non-cash trial in September ended trial double-blind XXXX. per $X.X commercial basic for decrease the to Phase lower to to period months Net loss loss XXXX. due expenses months to in of decrease XX-week or million was in stock-based ended a and a XX, XXXX share and a $X.XX per basic months primarily $X.XX compensation three for loss G&A compared expenses and period

$XX.X loss For ended $XX.X XX, and September $X.X compared no revenue agreement for nine in result nine for basic to ended That million. loss XXXX the increase to nine September a or September revenue $X.XX revenue $XX.X and net and basic with diluted million XXXX, share X was the of there an Collaborative a of was future was months seltorexant. XX, of diluted net increase XXXX was of The second performance months XXXX, period agreement. $X.XX income XXXX. the a ended for obligations of in collaborative under recognized quarter the million Janssen co-development company's during million per license for or opting of the the compared same net XX, are months its out as

the for any turn to operator call Operator? the to questions. like over I'd Now

Operator

Jason Butler [Operator question with JMP comes first from Instructions] Securities. Our

Your line now is open.

Unidentified Analyst

Type -- Thanks submitted you the about our material in for guess Thanks. since feedback you Ryan C facility? I cannot Hi, you've the in much for the have under it questions. agency for the have from else? but had on Jason. the material on [ph] then of sold taking meeting quarter, it the remaining anything the that ATM agency, the you about like say probably is looks or with any this, for used guys worth And shares you've quarter million $X how current and the ATM anything is

Remy Luthringer

first and give questions. will it Race. the second take the speaking. to the for you over part will part, Remy thank So, Geoff I I'm I

a you feedback the you date you your you As for meeting, the book days happens. and few to from briefing before know, when submitting FDA fixed FDA get the the meeting are have

So can get the asked we under of feedback book we early the different today as come receipt not I other one…? recognized you Geoff, next take still FDA of think such comments week briefing there will or this from is the questions the but week. as it later of any did

Geoff Race

We of in in $X second for around stock third the quarter. sold Thanks course. question. million worth sold quarter. of Yes, $X the million We the

stock we sold any place, fourth million quarter. million, leaves sold $XX in haven't the had We We million in $XX of remaining an $XX facility ATM. that ATM the under

Unidentified Analyst

Got it, thank you.

Operator

you. Thank

comes from Tom with question next Our Shrader BTIG.

Your line open. is

Unidentified Analyst

a the Hi, and of additional how making an be about I of Thank ahead with what Julian on my additional Keeping the outcomes for from your is determined there, following forward if Thanks. this mind next lot week, preparations Tom. still to in whether talk meeting could that NDA been possible you could an you move trial? FDA fast here, or was range taking the is wondering meeting question. analysis you've for you from for

Remy Luthringer

Important we guess compelling and different question are really and the confident extremely that the also have we put as you are book, FDA have anticipating generated the understand can with we briefing data. all we we data outcomes in will the that very

And we of next obviously, first have anticipating can part FDA the As another this you are effect studies already score. we Phase phase to of we Marder study, the or is showing this two us two on are primary which Marder, what extension the would an have seen, next Phase we also the negative doses key which all that and be that a are when quarter really driver, don't Xb According happen. endpoint, to is and analysis if we are end working you X, combine is already anticipated, the the this indeed, We effect extension a seeing in we will not functional study evolution are have improvement. of steps any outcome doing or a and of the again, requesting will that driver currently year. know we we the also the on obviously, but do expect the a is

feedback, And the is FDA during feedback the different in extremely get so, scenarios. we ongoing, and anticipated of types think final able we to be all react because have all I will of this we the the will when preparation is these fast, December, course from all

Unidentified Analyst

got Okay, That's it. helpful. Thank you.

Remy Luthringer

you. Thank

Operator

Thank you.

Our next Joel Citi. question with from comes Beatty

line is open. Your

Joel Beatty

help design another to you any the needs differences success? that taking done, trial discuss X for could Hi, my questions. If Phase enhance of trial And be thanks the probability potential there? could

Remy Luthringer

so be interaction of I Yes, I clearly, will are with study Yes, not or clear the final are FDA. there run based but mean, which obviously, mean, the that them. will feedback we on parts design the discussion some the completely the

for drug we nine extensions as the -- of here, is have year the in this the you example, for box have we will not one months as to really extension. patients an already here completed XXX study, to as because extension a a lot to is gets know patients exposed So, today, have the and of extension who of this fix

are hit taking So definitely we’re we box. -- this

discuss study, terms come which discussed, we the kind for the endpoint, will concerning about I brackets, fine score this will the be can is from where if the guess it endpoints. coming did I mean, will the the Phase see X. as in of as primary negative endpoint, think PANSS It we Now can from negative I Marder put PANSS be out in Xb secondary and modifications that of like but how can scale Phase still improvements out or I maybe tuned, to symptom some say, but some, in but I score,

mean, have very are, they from total the already good these teams improving we better. know, a patients on I are functional mean PSP scores are level that levels, functional functioning you I with As

best and maybe symptoms the ever because we fine this my as tune has in improved as of aspect know an of can functioning. [indiscernible] improvement negative the a knowledge, terms consequence So

this think might to if study. is do have mean I the an I end So we additional discussion where

Joel Beatty

That's great. it, Got helpful, thanks.

Remy Luthringer

Joe. Thank you,

Operator

Thank you.

Douglas from Wainwright. Tsao comes H.C. question with next Our

line open. is Your

Douglas Tsao

morning. good Thanks taking Hi, question. for the

XX-week just upon, measured are safety a to have that been you longer of to at, have sort lot subjects would of being you. but sort relevance of I'm the obviously, or additional purpose are sort enrich Remy, key, the extension, of needing there that is but just are running And ongoing just to that of already label are term other that look Just, sort that, of studies as with endpoints there I'm beyond there do have curious detailed potentially any, some the open and sort the studies touched of curious can commercialization data typical the Thank support set? you like that you really things to typical, about XX think interval? think

Remy Luthringer

or very very this here. opening Doug, you're important important question a point is

are we already measure measuring safety, discussed we and year this we to safety think so together, yes, PANSS, as efficacy continue the So I of one clearly, I ticking continue mean, well are here, box measure long we term we but PSP. to

data think at So, for for we day significant a have I efficacy. of end will patients number the of the

basis over is this I I are we negative we analyzing Phase important FDA. see what meeting going. the be, to So exactly on aspect are and demonstrate followed beyond think And this at to continue will will obviously an and to weeks, improve important But we things carefully obviously very after meeting, mind discuss any relapses to of how is think interface data aspect and is phase this can well. the aspect mean -- many slightly it because and as beyond a is X stayed there regular have think meeting also I board. be from this is, many think another functioning patients important to have to monotherapy, hopefully, patients I the a symptoms how we dropping know measure be from I double-blind the very that one a on patients which in is with here this could is first thing the are so patients discuss that and if we this relapses mean, study positive the addition we're symptoms period on upcoming dropping And we safety XX to stable of improving at was have because out patients an which hopefully important out or Without where keep of and we and year, that demonstrated and the able we not how even in this using are at demonstrate other is And are these for have aspect study all reason. for symptoms. positive psychotics as the is or scales some which one a important, important aspect I many there

coming what mean, this continuously, I the say be we data towards that of lot the data to are FDA, probably extension. right are direction. discussed I a out this are are I of and lot can pointing with So from is of A think interest we and monitoring

Douglas Tsao

from the extension label investment we from Okay, would expect great. see And the the reminded you that, extension? to Remy from when could community open data, there or

Remy Luthringer

have will first the last of patient quarter the year. during we last visit next So,

So, delay which really, mean, I I don't see anything would this.

a towards the So you probably should to see something as so quarter. soon as data, of analyze end of first beginning we chance second the have quarter the the

Douglas Tsao

Great, so thank much. you

Remy Luthringer

You're Doug. welcome,

Operator

[Operator next Minter you. Myles Our question William comes with Instructions] Thank from Blair.

open. line is Your

Myles Minter

questions. Hi, thanks taking the for

Remy, wondering endpoint versa? a what the further the components to and trying for you on Just may PSP is I'm can to that what missed are the fully probably of significant also the or unfortunately, be better components and you in results between to capturing efficacy understand modest or PSP you NSFS, what capturing done the the don't, the regulators so saw crossover slightly that that have scale important Marder what on drug. differences vice and this get the be not sense reflected understand analysis

Remy Luthringer

is question, This a nice Myles.

split two score with is that the you I PANSS possibility this is why the you have out dimensions, score you way have highly you a what little the And coming I'm you experience. that than what or the expression out where from this, So get means, Marder hinted I presented or the functional of the data, to keep correlated experience bit linked in to. into know a different that improvement. think have and you analyze data think also, negative Yes, is to mind as can saying

we has literature. line this So a effect if described experience. of significant And XX our the terms have been you really week very even when remember in well data, results, top in our we presented at

with I brackets score, a is in if it mean, have a I correlated. is see I I improvement Marder total in score already, what what and the really as mean improvement PSP think in seen of this to we and put functional functional what go linked So is you you'll sub negative score. this

it's a you'll XX Xb same. with in think Phase I that -- the again, significant mg X exactly have is the effect surprise XX and better more milligram size Xb. PSP not Phase a we a the into stronger not a But that with again, if surprise is I or say remember, had Phase link and And showing in in the like so like the I there here. you Phase in Xb a is giving to improvement functional mean improvement

the which to negatives might is why and really you for sorry, to and PANSS missed for you the Marder symptoms When psychopathology. negative yes, the not also coming and that symptoms. added from the negative significant have in according keep not really analyzing have GXX, the were and obviously from items, more And scale total way out general week-four five negative week-eight analyzing lot, Now compared be is is out or looking coming score, the is out GXX score, we what significance, coming for week-XX. symptoms example, is I of which mind positive as really mean, Marder PANSS you're negative you're show from discussion that which linked, maybe more to did example, common, afterwards, placebo for are a whatever really is

to less excuse addition symptom, to experience, of score than I think, expression what is expression, So sub me. of a in negative probably is linked

PANSS, SAP demonstrate Marder think, on out last the [ph] again, PSP. of I really, score inside analysis, all and not think to we to avolition. even again, is based I score an going but a granularity, having be more mean, So sorry negative I PANSS of functional could so by the from as the least, long, and but towards coming negative pointing estimate form And improvement,

you If Xb. in Phase remember, the avolition a was driver

you our is drug very compared extract score, avolition again this a to If really see avolition, giving you'll that with from again significant effect placebo. Marder

I compared the comes So story to Phase logic think the together. It's Xb.

explanation. think my I best is this So

Myles Minter

getting maybe near Now, coming think about filings Geoff. case another you there this any of is Thanks. can And program company opt for as into of How that's, meeting to seltorexant procedure being over is think off cause out I for also, into versus running opted else. Phase trials? now you X the guess, the you then that that trial And the or table -- when needs differential completely best has scenarios that's line? the one do proceeded and that helpful. something Janssen back the term capital is out you

Geoff Race

Myles. second take your first. Thanks, question I'll

So and that's there opt sort final of in back warehouse is the no position.

of number and in need a the at the Obviously, we Of is obviously, you FDA, once point priority future the royalty making to will what in future. single mid study order depending your that as get seltorexant point continue our have first the course, sales steps NDA. Phase on first then we'll the to complete. to that a to question, back Janssen raise back in to coming extension capital the obviously, we of know, go And some the worldwide be from file is at with there's through digit some to X have we on

obviously on is it's discussed that raise the size speculate think that finalized, investors that with of number FDA that what we and after finalized. but I discuss the with will and be, we've have to early once minutes analysts will too capital

Myles Minter

XX, on Thanks questions be luck and interesting. for good everyone Thanks. answering the November should

Remy Luthringer

Yes.

Geoff Race

Myles. you, Thank

Operator

you. Thank

comes with Biren question Our Jefferies. next Amin from

Your is line open.

JeetMukherjee

guys. morning, quick Jeet This be is Biren. me. May questions two Yes. for Hey, Mukherjee on from good

mg get Remy, required, for PANSS confirmatory First, significant. second how quickly that item seven is, up your think statistically showed perhaps question you data, study and if I the dose another was the could score, negative running? And on the is that XX classic maybe

scale scale on Phase endpoint maybe as the to any the there a X Marder or so perhaps for any be classic analysis Thanks. items perform that required? didn't which is use you do And subsequent part co-primary So primary your perhaps on well? from might plan

Remy Luthringer

first the questions. one this addressed so Yes, I one part already the in previous of

button for to mean we completely ready an So are needed the additional push if study. I

work have feasibilities, study. CRO So the in we run anticipated with we study to anticipated the CRO we infrastructure a of have have order anticipated we and terms in design, how will

really this ready go So to afterwards. is

previous as and as of have minutes have a soon regulatory question-by-question. mean, we already. You countries, I soon little to and it, do, analyzed these tried have Coming on things part, kind again all second obviously, do as the approval have we we I definitely, to a to if have always mean, to to we in we based the explain what linked different the I your what Yes, we know bit it's item-by-item, as as but the question.

and are which that PANSS we analyzed is score extremely negative in items the and know our clear And or related questions, mean, to is of a from have drug we from the you're the compared placebo so just particularly I active that confirmation out Phase what results as needed We if the it's this PANSS seen Xb. have to avolition, mostly very going coming the to said, I I mean, with Marder. if according

to negative also improvement improvement placebo. again again, mean, mentioned, expression and PANSS can mean the can functional I sizes according see I you split experience effect are compared with questions/items, really are I or good As Marder which significant score we very mostly the to and that mean related to I into here functional to related

all think are maybe significant a of as the this, are PANSS when current think scientific going to significance. is really as a is functional improvement, yes, are left, we same community, more what on I consensus improvement. connecting, measurement as a all questions KOL few comment or not general medical the the So which as few of a you're showing literature in an important losing of really I left patients, everybody's is really suddenly, These is and mean, adolescents and be their agreement, extremely schizophrenia. engaged get well but afterwards. these what anhedonia, of like is basically very consequence which happens to in is with that patients avolition of I presenting whatever And to demonstrated they're mean, alogia, avolition. ability is interested want, I this are showing an is are is symptoms there But, which driver not key not you in statistical mean, really what it a related showing items I obviously cool again, really are which activity, other the are which stance a that's to And avolition.

parts of a is symptoms and all and that FDA we will symptoms It will not addressing negative exciting with a basically, I mean, construct it's which about really I construct I'm around think speaking because more So have discussion is have of these. with a sub specifically I a this a drugs is very know be FDA, the to an that the construct, the scores, because FDA, interested here discussion division are symptom. some confident constructive I'm interesting psychiatry in the

Jeet Mukherjee

Great, thank you so much.

Operator

further currently call I’m showing this time. to any Luthringer back Remy questions remarks. And closing at you. Thank for the no over turn I’ll

Remy Luthringer

thank much. Yes, so you

all all So for you for thank questions. listening, your

the together. data minutes agreed will with the this soon important with really I have is -- guess, as soon meeting this the have we really on all on mean, as on we focused final the all think obviously you all as very as we share I have of complete XXth And will the you we company we FDA, are can And November. questions. as

take you again So care. and thank

Operator

presentation. concludes this today's you again gentlemen, participation. Thank and for once Ladies your

disconnect. great now Have may day. You a

Minerva Neurosciences (NERV) 2 Nov 202020 Q3 Earnings call transcript