NERV - Earnings call transcript Q1 2020 | Minerva Neurosciences, Inc.

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Operator

Welcome to the Minerva Neurosciences First 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 conference 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 first 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 Rick Joining Minerva Race, Dr. and on Financial from me call Chief are Officer. Chief Geoff Remy today and Officer Chairman Executive Mr. Business and Executive President, Luthringer, Russell, Executive Vice Officer; Chief Mr. President;

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

that Before expectations, we today's company's about and include plans begin, forward-looking future the statements I will would statements. you that remind discussion constitute prospects like to

filed Risk with the more report actual differ Safe uncertainties factors in are a based the of the statements with For provisions current May These and XX-Q risks XXXX, purposes are cause due from for forward-looking fully differ Form XXXX. on those the March statements filings expectations caution indicated. Factors our caption materially Securities Act are XXXX detailed SEC ended variety that results we that our XX, SEC, Harbor of including under quarterly of these to forward-looking materially from our X, actual results may that Litigation quarter to Reform and to the on on the under may subject Private

any that today's reflect XXXX forward-looking today's call and as events any of to law. X, these date call required May made or obligation statements Any update on of this only by as after circumstances to forward-looking the except occur company disclaims statements Monday, speak

call the turn to Luthringer. like to over now would Remy I

Remy Luthringer

Xb which is is clinical hope you, Today, us. roluperidone good pivotal Phase X two stage doing in on seltorexant Minerva's advanced Thanks which and everyone morning, for focus Thank I completed products trial Bill, and testing. will Phase well. everyone. joining a I has

we The readout of trial the symptoms Phase are key compound from For expected event our rapidly company's X schizophrenia. roluperidone, in approaching negative treat top to results quarter this with line for this XXXX.

For seltorexant, Pharmaceutica, Janssen X for a our evaluating of along with are we partner Phase number trials. protocols

will score. roluperidone. by randomized Scale. is of XX-milligram Phase evaluate the XX-week The parallel-group and to with roluperidone, negative the as is I begin Marder Negative and measured safety The X Positive factor Syndrome a a trial primary study symptoms double-blind doses XX-milligram efficacy placebo-controlled and of endpoint

include endpoints global and scale performance personal clinical social Secondary the and impression severity. of

announced last the double-blind on of a the have trial continue extension on by to patients we patients may of phase is sites doses have and followed receiving roluperidone. the drug been February, two XX-week enrolled placebo. of XX-week and patients As and clinical in randomized XX-milligram XXX of U.S. at and in Europe. been the The the a original dose of open-label core roluperidone their this one The to which trial doses period, receive XX-milligram patients have X:X:X total placebo during option

by unaffected in trial the to been has date Progress pandemic. this coronavirus

trial. The XX-week We double-blind core taken continually of access of patients safety and and each ensure to has our study the to in the are contract place research trial organizations monitoring drug. their patient site phase last the visit

and have XX the pleased completed the from am patients that patients phase, patients extension to phase XXXX. as period the transition XXX XXX have double-blind phase in have of total completed into open-label report double-blind I extension to April the elected XX,

communication the Phase month. from Phase of by has with design beginning of the and our analysis of data the We The this look agency. to with feedback FDA subsequent been log end database beginning the trial forward X and late X informed meeting,

prominent of the Phase symptoms community, leader trial. has highlighted the since opinion been increasingly role X we key initiated in The negative schizophrenia by

of fact, by of persist lifetimes view thus intermittently symptoms roluperidone shaped of longer limiting and term. and disease, worsened In the functional negative the development vocational social over of present over has the a and while been integration our patients, during fundamental course ability positive of symptoms preventing the the the the schizophrenia, majority severely

the currently No conditions, effective drugs and schizophrenia development are disorders. disorders, including present treat negative or of in neurodegenerative approved to negative other symptoms disorders symptoms

data possibility to this the the pointing unmet X beginning way significant with negative We need the symptoms of are and new paradigm medical for addressing excited about schizophrenia. a Phase treatment

three are we upon for seltorexant, Xb Phase positive seltorexant XXXX, insomniac including program the the X during this promising trials Phase completed without Xb comorbidity, to trials of Results build to plan Phase that as showed has elderly on Moving positive those seltorexant compound. MDD looking profile. patients patients on effects current safety trial do SSRIs favorable and within SNRIs, one a MDD with major not patients indication of also X in consideration In in particularly in improvements adjunctive insomnia. for patients symptoms. with with showed insomnia to is patients mood and depressive under respond adequately The treatment target disorder, who we Phase

the our recent and including several to discussing Phase protocols during support X feedback received FDA are partner indication. from U.S. our end of Janssen X meeting clinical development Phase We the that into strategy,

and achievement Janssen agreement. the our program control milestones of discussion with under defined also Our of include decision-making

about trial. would having and improvement Xb is of specific I randomized conclude, like roluperidone knowledge, To of a negative I to best offer shown primary a only placebo-controlled the symptoms a our direct few Phase Before roluperidone. clinical the to-date drug in additional double-blind thoughts

study Additional improve demonstrating unique agent. what data cognition, further qualities of this that of plus functioning shows we believe mood in terms and from the are patients also that analysis

negative monotherapy to in test cathartic trial therapies of antipsychotics. And for effect advanced. atypical co-administration development most designed X clinically the Phase Among efficacy roluperidone placebo is emerging symptoms, has absent as versus its with been the the

future. X the share we to Phase top We for plan line are not-too-distant from roluperidone, possibilities results the the the excited in about as trial

over now Geoff. will turn to I it

Geoff Race

this more our of release Earlier for report issued filed XX, results first a Form found press may earlier operating results the be Remy. the quarterly discussion you XXXX. morning, today. quarter detailed on our we in XX-Q with March our ended summarizing Thank SEC A

equivalents $XX approximately that cash million, and cash as as change. into for the company's mid its may March upon existing operating XX plan. of routinely evaluated December were at anticipated least capital and estimate are XXXX the to this million based on expect equivalents assumptions to months marketable late our and meet today is based compared securities XXXX. $XX.X be from presently to requirements and XXXX of restricted The cash current next sufficient which XX, Cash, XX, cash will be subject We

in of expenses Research X and The the R&D $X.X XX-week Phase in expected roluperidone. first MIN-XXX roluperidone the of to were expenses the trial trial first MIN-XXX. expenses clinical reflects lower primarily development compared portion quarter double-blind Phase clinical decrease the the Phase XXXX, development XXXX. for decrease the and of Xb R&D million with trial in X to $XX.X and of expenses million quarter Xb during of XXXX the clinical of of of the are Phase completion trial

and for the $X.X loss or of fees. first XXXX, expenses the per due were expenses share expenses to and quarter to $XX.X million in to million first decrease net first the Net million was G&A $X.X compared non-cash diluted. administrative decrease in loss and $X.XX This in or in diluted, XXXX of the basic per loss million stock-based a loss the a primarily quarter professional decrease in quarter of of and of basic $X.XX XXXX. $XX.X quarter compensation share of XXXX for a was compared of first a General

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

Operator

with Instructions] Securities. Jason comes question [Operator the first you. line Our of Thank from JMP Butler

is now open. line Your

Jason Butler

of III Rémy, seen you blinded on what Thanks. And you've an before, symptom again the had basis what the Phase you give positive II of the but questions. basis us in taking update talked then the I trial seen for blinded wondering with you for remind the a this on just roluperidone on baseline in trial. Thanks characteristics you've relapse? could a if Phase terms fast know in versus Hi. data approaching, about us

Remy Luthringer

Hello Jason, hello everybody.

completely to the terms around for in obviously IIb I have blinded I exactly with by that merging the say And symptoms clearly, study. that is score obviously together – patients we are baseline. which great who a Phase all III it enter And mean monitoring what the Phase we true news. you mean, up we symptoms same entry at ending the are was of the as So is points the know negative I negative XX had in

of dynamic the give of overlapping negative phase weeks and even bit can a that between see the Phase during over you you mean IIb we Phase two double-blind I telling I studies more terms granularity, is score in little III. and the the the behavior first the XX what the really And the

There point see is you that, two of one limited III Now which can is about a we the mean concerning comparing again tell studies. relapses. is But is is the the relapse. Phase level I the again what IIb in a is what I and Phase relapses the can debate line and between

Jason Butler

bit Can to as me. ramp are a your a year? to your speak launch just year are what commercial Great. little next preparations? achieve And more you And one where just throughout you you towards this then potential for goals in

Remy Luthringer

over So maybe I this can Rick. give to

for words this some say you can Rick question? So

Rick Russell

sure. Yes

good Jason, So morning.

of first you may supply So we've a agreement there, of so signed recall commercial all Catalent. a couple things already with

name. be obviously have a from supply trade received launch. commercial conditional available FDA we'll ready at work So the approval continue also to to for We've

haven't We yet. released that

We will future. the sometime in

positive, have we'll here potential U.S. There's the co-promote Once relationships of enter in within psychiatry companies formal dialogue the kind of already more that out reads a data partners. market. number established with

out with a we're existing with think if someone and infrastructure quite and that and interested co-promote essentially we reach someone some do to folks I can see that. align like So those talk has to of an

Jason Butler

the taking And looking question. the for forward to data. Thanks

Rick Russell

Jason Thank you,

Operator

Thank you.

Citi. next the line with of comes from Joel Beatty Our question

Joel Beatty

Hi, taking question. thanks for the

The came first late one on There integrity. is around been year. had issue that an last up data

to those reviewed have that patients patients? have the I on blind So confirm you'll just double XXX for the that all guess data study have completed you

Remy Luthringer

could study, the we -- in aliquots two randomized of yes clearly of no to the impacted I study one samples patients the precautions the on include of we site. all mostly this beginning explained the Joel, speed blood took as example and have in for screen in integrity because the but on from patients calls, impact previous data

analyzed really impact to ago we -- be centrally it a happened on and I site. kept any months send one did few here. experience what not mean, One about

I impact no of very analyzed. the is regularly XXX And because COVID one patients topic also these about we COVID maybe clearly over also all clearly be word this as So, hot guess mentioned very can past. fully a

Joel Beatty

arms dosing two And question guess there's Terrific. you of I a remind plan? us stats could that given the

Remy Luthringer

This great is question. a

first mean we one to all, So that which yes? if interesting I already And point a received not with shared our analysis the even requested we the data. is would way confirmed feedback of we is FDA the like it analyze plan statistical

the because but We're the and with We Hochberg corrected is them it's correction. will becoming one is statistical type analyze not reality, analysis it plan error clear approach the data MMRM ITT. for using

endpoint So primary the first a basically what XX-milligram. placebo it and between the dose means doing highest comparison is as of that you're

And hitting for second the you the for divide dose. can you analysis two to P-value have the P. X% value not, P same the significance with of X% second you're dose do If values by the the if

it mean it's XX-milligram will claim I means longer no And but be PX.XXX significant. that, to that in PX.XX basically is order this

registrational strategy, this in been the the remember was Phase is study. which used you analyzed as Xb by the because the same Phase has we a a way yes, Xb, like So,

Joel Beatty

sense. how would one costs could sounds Yes, next makes going us it. last for be with about that tell FDA It had you've If Maybe ahead. you on the it development? split Got like on part of that seltorexant. discussions program question does the

Remy Luthringer

I guess I Geoff. give to over this

please? Geoff, answer can you question So, this

Geoff Race

as with amend the Sure. result Yes. Commission part in the the regard seeking insomnia program. were European very a of to agreement that we market X each funding that which approval Back The is to transaction time. agreement with with we the required the of of Phase get was party's have XXXX connection responsibilities for Actelion J&J intervention clear terms to and in Janssen at European in

X requires X agreement to will cover insomnia Phase Insomnia amendment million to the Phase cost the costs side, on the split basically to J&J. other of give full And But $XX on then the program. the a contribution XX% J&J the MDD we Minerva program, XX% program. and the the Minerva

Joel Beatty

Great. Thank you.

Operator

you. Thank

line of with the comes from Biren question Jefferies. next Our Amin

now open. is line Your

Biren Amin

taking questions. for Thanks my Yes, hi guys.

Remy, So, should have the enrolled? about we patients that that versus XX% completed a in Is dropout press think release, you have trial that a seems how it rate.

this to imbalances the trial rate? three what -- how in number I were for dropout guess were there any of whether design? does your And compare assumptions terms the And arms across

Remy Luthringer

So, the answer last one part cannot I the first because first study the can question is I blinded. answer, But yes.

you up if is assumptions double-blind if which with with over XX% weeks Phase first the in yes ended in the remember had So, line XX remember basically. dropout the we we you what phase really and dropout the in XX% were Xb,

less So, news had than good in assumptions. what I our because think we powering is dropout this we have yes

Biren Amin

when able its the terms came think extension. XX open changes benefits that Okay. Can to data And were the then open-label in symptoms at anything that these they negative see of you us to patients the completed you open-label patients label, I look open-label that what exited? tell on into when the have Are given the you these have completed patients patients? in versus data they or about

Remy Luthringer

Yes. Sure.

randomized So, if just in on -- stay one the label, And going doses. are XX the XX. patients mind XX-milligram but there as placebo XX-milligrams the who have are on that been into will patients will I of patients on open stay keep two on mean to

have, no know have roluperidone. we don't placebo that they yes. they which is dose terms patients know dose we have today don't mean but in we -- So, but know a of what I that

of ,we this for to drug is exposed know, primary one are the But of tick the box extension you XXX yes, the patients these obviously objective as patients indeed to year. following

but or for to the have go FDA. this take So, to this to you box the safety go is aspect, really what do is to the to NDA the

going already I still news patients have extremely XX really and of we So, a completed. have because think this we lot good is on have

this really good are shape we think for in now. I So, ticking box

much of and efficacy We're for it obviously and think efficacy patients terms well. Xb as phase, things details in having as behaving the following these double without the are in of I terms blind the safety that in like Phase as was

good, and so far reassuring. yes very So,

Biren Amin

Phase start And the seltorexant. key X gating items then a starting maybe X? the What anticipate do Phase on are Okay. this of And question year? you

Remy Luthringer

And So, recently we & phase our got several had meeting end obviously, this Johnson we of Johnson. with colleagues feedbacks. from

was concentrating focusing the responding mean really on are obviously these with the as indication to patients MDD I if know was primary meeting insomnia better who this So, or where key question population.

a not is some you and So, the of has into going all -- been clarified. or this how I do in and was think subjectively really subjectively clarified what discussion this quantify details also objectively, only point was more without as

more with But these as pandemic and know -- adopted the are finalized. And feasibilities as we we we are speak So, have protocols going on. feasibilities the -- COVID are the complicated.

currently we but pandemic. So bit ongoing, is due COVID what so working But ready, slower is the to And more soon it. as than as will we expected are on details. give you this we little are a

Biren Amin

then your question. on finishes? last are thoughts the once maybe R&D III expenses the just Okay. Phase What And

Remy Luthringer

will news retrieve psychiatry I the do really obviously you you we of know, positive in a this. you As I this with symptomatology we disorders things have a if space transdiagnostic in of inside that the and as different work And data because I ideas, know and are urology, negative of -- schizophrenia on is lot roluperidone, the symptoms I can think indication. all we will several even we yes lot really mean, have mean, have good

I perfect up as have we today, with the we many of think too So studies. end and together word put

some currently to priorities taking carriers of internally, would the what studies of after also to be advice our from results. we do line So top discussing are

little So bit stay a with us.

We brainstorming. are

unmet We and value two moving lot are at first But which in have exciting mind, yes. highly coming forward. mean think have way a up medical create I with very three cover of studies all the needs we will will I we best of that or minimum,

have on obviously mind. forward, molecules what move the roluperidone, the is plan beyond program, I our place forward also order work have to to in to other this in you but in in also think move So seltorexant And the a pipeline. we

in made. to now of work be priorities But So but again, I come. a lot clarity just have think a progress, lot to we

Biren Amin

Great. Thank you.

Remy Luthringer

welcome. most You're

Operator

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

line Your now open. is

Myles Minter

guys. Hi, Congrats questions. the taking and for thanks for

-- but going the Just Rémy, more the over specifically, you And after types follow-up across are there. that got COVID-XX of the a you sites these got any these last if not data, time may are global we Thanks. top trial? expect to into the nature broadened we portion. line a may talked wondering or clarity just I'm that mentioned there entire month of not have delays open-label ago, potentially are I've impact may have or that. U.S.

Remy Luthringer

guess, I what the no will no the we of forward, to end due of moving on April, the impact for predict yes. I COVID. had what that extension end moment, so happen But Myles, month But cannot Yes, we I obviously, on impact last COVID extension. is have the said of of as

So all sites of lot. and -- patients. in we have in for I been possible good have and say CRO EMA the our sorry order and put And extremely is to the out efficacy that exploration we reactive really But FDA to with extremely in terms from with news. evaluation place that mean the efficacy think implement what coming the the continue I safety I for we have has which guidelines -- reactive been helped to a really and is

have have we country, that you the As country. in about we remember, also drug in discussed we enough -- think the fact I each

in and to an to impact obviously. the was So extension this each each the to bring have patient side drug that will not

so far so So, good.

to continue We monitor.

We FDA are the things. again, We as very are -- again But today and given the we monitoring remote kind these the guidelines EMA no about interactive. obviously of possibilities using impact have example for speak. by we

Sorry as about the last U.S. point

point one. really European patients before the the I I sites. Remember So U.S. started extension. U.S., this forgot mean, limited last still in was of clearly, that sorry, have mean a number U.S. about I And we

we any well. extension the problem have in think with I as So the will U.S. not

So definitely, moment. for the I no the in U.S. mean, impact

Myles Minter

of extension phase proportion completed So it patients patients? say XX that would U.S. be to the fair significant are that a indeed that have them

Remy Luthringer

But XX months we first U.S., a definitely yes, the mean, the sorry, one coming have It's yes. I clearly, completed indeed, the mix. were from

Myles Minter

And Okay. release Cool. indication the mentioned but have you that comorbid this with you adjunctive seltorexant. press the in insomnia then just insomnia, on didn't mention about Curious alone. MDD program you're may chasing

wondering that I'm MDD MDD like placebo Cheers. obviously background rates whether response a with priority patients placebo taking in in then So Obviously, the part responses that. whether the trials not And trial? crucial the here. that of that trials, outcomes into taking And is I'm are those things wondering large whether those to with or that's Janssen plays patients insomnia potential are these medications related zolpidem that without. different may like and comorbid coming like be to to

Remy Luthringer

always. Great questions like

the yes we cares think, in of two had and zolpidem are we But tolerability clear. in and better the So, I mean and our mean, a profile move I the comorbidities, was But in I standard mean clearly adults really objectives and of the to data we process. straightforward I part insomnia I elderly were clearly forward. a any nice very excellent. mean is this remember, without patients than so are data indications

really quite surprise. mean, a it's mean, no forward I path easy yes I here big So,

you There is looking was it. Why I very because meaningful. the about indication and no response of There becomes Obviously this a you're and clearly, little the insomnia This really doubt treatment clearly, it MDD, of very, in I rate responding better. patients mean to a between no and the placebo, are mean, it. these significant is is about I mean And much when better. is the was delta complaint have very, doubt and very MDD response tricky? more bit when data-driven.

say and yes. to much, minimum So, I when patients this if clinically do clinically have want insomnia much because don't at they I is MDD meaningful, know, but are doing better meaningful these not as

why So, this reason the bit about think to longer a all this. it is took little

I my mean of final the I response, been -- a placebo response. having it did R&D maybe of best did has have not I be have and it because terms my of your in colleagues we'll happy answer I different Now report notion we later. think any no have don't placebo not I to done knowledge in But to question if

placebo and good patients no know, you how response a knowledge you have is how you but is your difference. trial, As select run about I

looking addition a drag But if seen have clear between I the when that, is there is we patients and MDD we the what you're is doubt real to again no placebo difference insomnia their effect that have to mean treatment have disorder, in here.

So, the I'm very placebo moving struggle will forward, confident effect. not we really with that

seen is think comment with people more because, think What are stressed, current important, as after I -- losing is think about and is patients phenotype beyond the going from hard MDD more yes the happen anxious. this mention much pandemic before people suffering you are what think pandemic, have ongoing same I probably are we which to the I a not the to have the that know and is seltorexant what people their we have pandemic will and than I job, think general

to I we are when reconsider this discussion is again have so -- People running something trials. we think

more important becomes think considering. but more parameter another general it debate expectation and debate. this think considering and is this -- here even the maybe I we So will Because really just to important is are maybe be insomnia a this. I But

Myles Minter

Thanks the fair. questions. for That’s

Remy Luthringer

You welcome. are

Operator

you. Thank

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

line Your is now open.

Douglas Tsao

the for Thanks taking morning. good Hi, questions.

roluperidone Phase can readout how -- -- file seems or III? do position you patients you given just for just you. the which in -- the long how quickly timing of you the get of XXX Thank for be terms in would to NDA once the think quickly, imminent extension, in Just the

Remy Luthringer

it's ethical Doug, you know end months. as stays the mean I he into -- stop until any patient if trial XX the this to the not of

if some basically double-blind if XX staying into I box last these to the phase phase the double-blind extension, the of months, of I -- go nine who the mean have the end. the XX mean the -- these months, patients tick patients completed are So, ended following will to they so in

And data so will -- will extension many get? extension get we'll to how box we more be get the than need XXX tick we the we the the has much Probably to about completed. safety, but

happen So as end next of year of first so. quarter this will beginning or

we cannot So this. clearly change

so as And on do to have has exchanging becoming open is topline understand my But when will the really Jay really is understand a of that with of regular of a lot worked meeting to Saoud, is FDA, outputs FDA who and we the more FDA. and know addition fully order the in you it and obviously will And to what we this we kind R&D very share And primary secondary have is this in the yes. are and endpoint data. charge base pre-NDA with FDA. discuss with now the colleague, we a common we have this the really lot the more results, in

extension will positive have to the need for and we to start hopefully So, NDA. based complete we data we to again, FDA. of packages the will a all But with this the to the end work on digest go

Douglas Tsao

you. Thank Okay. Great.

Remy Luthringer

Welcome.

Operator

to the today's Thank remarks. call back I would to for question-and-answer closing like Remy turn now concludes session. you. Luthringer This

Remy Luthringer

Yes. so Thank much. you

to very So for you earnings important the our thank call. everybody obviously It company. moment a is listening for

of work, readout We shareholders. for of hopefully and for lot hope our a lot value are the patients very close lot creation now of of to a a

am Phase and I very to a soon forward nice really you have So, you our about day. very, very results. looking Thank update III all

Operator

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

disconnect. a may You now Have day. great

Minerva Neurosciences (NERV) 4 May 202020 Q1 Earnings call transcript