NERV - Earnings call transcript Q3 2021 | Minerva Neurosciences, Inc.

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Operator

Welcome to the Minerva Neurosciences Third Quarter 2021 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 Minerva. call like Race, to now of President would turn over the Geoff I proceed. Please

Geoff Race

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

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

Remy today Chief call Chairman from the Luthringer, on Dr. and Ahlholm, Executive Chief are Fred me Financial Officer, Executive Joining and Minerva Mr. Officer.

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

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

Frederick Ahlholm

And Thank we us late study formulations morning's good concentration, and joining detectable trials, met the extrapolated the the area commonly for formulations. last On as XX, commercial XXXX, key update results I pharmacokinetic in you, formulation like under concentration, Thanks focus Jeff. evaluate planned manufacturing. Phase various from used III employed bioequivalence Phase formulations. with the the Cmax would equivalence This morning, this plasma on bioequivalence September curve our the scale and to demonstrated between announced the program AUCinf, to under was of well our where everyone. roluperidone. infinity, type across pivotal large various in supplier value a to to the to are to and results of facilitate Because the today. compare as objectives the the commercial IIb objective most study in parameters study curve conjunction designed area plasma maximum the pharmacokinetic AUClast, the the

the under And milligram bioequivalence, tablets and fasted formulation terms with were planned conditions this terms planned to of the conditions the in for formulation. tablet milligram both of the under AUCs data tablets XX are bioequivalent commercial use of of intended on dose in milligram had as fasted dose formulations and planned is I schizophrenia single III of the the represent the roluperidone. based controlled chronic the the study, planned efficacy XX is of the XX path conditions work of the roluperidone shown In data whereas the two and of bioequivalence this under objectives when substantially results negative study. two XX the bioequivalence AUCs, on IIb drug, Cmax objectives the bioequivalents. reformulated of administration the comparability of study, And along the to showed used Phase under XX and III of the Minerva's most milligram of establish, to based milligram the of milligram of in the believe dose measurements plasma AUCinf we progress patients compared in formulation summary, improved of IIb and Phase formulations critical fasted XX reduced between submission AUCinf used the important condition. i.e. The roluperidone fasted release, earlier compared our of drug. milligram important and The also the of commercial an In used of Phase Phase margins roluperidone, compared that Cmax reducing to Phase driven milligram mostly AUC commercial tablet for with formulation formulation roluperidone For dose XX symptoms roluperidone of Cmax Furthermore, of that towards has of by comparability the are were assessed formulation the determining by two the study. NDA met. administration the were III. Phase In is a compared Cmax IIb most AUCinf commercial collected in both for demonstrated secondly, used exposure the safety been roluperidone firstly, in a tablets relevant study XX

Moving Type request announced our Type that plans for C proposed denied appropriate. recent meeting request the a and for meeting meeting. FDA. that company's we guidance with the the week, would more the on a C the company roluperidone pre-NDA to had to correspondence be FDA Therefore, Last

represents update Application to of of important we NDA Subject to study successful to completion the package. bioequivalence the this my a and the submission so, first component morning, of an New XXXX. the the from the timing the work Drug FDA, of in of towards half conclude feedback And continue

the R&D at new Minerva. this financial of to for Finally, I like head Kuchibhatla I over it would opportunity turn to Ramana as will update. Dr. now take to Fred welcome our

Frederick Ahlholm

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

of agreement, by in additional Janssen. Our company's achievement certain of in of up commercialization receive strengthened has to XXXX, $XX to interest from further Pharma regulatory acquisition the and contingent significantly milestones upon seltorexant. was with position royalty Under payments, cash payment in the Pharma's in receipt this with potential million the Minerva the January upfront Royalty $XX Royalty cash million a clinical, connection a

Pharma, respectively, nine sale this our been of interest The Minerva months ultimately recognize a interest from to related Minerva's result the Janssen. XX, sale non-cash to to XXXX, payment agreement. cash $XX amortization royalties. ended from three sheet to $X.X Minerva stream received Royalty to million received Accordingly, As the the royalty and the September in expense related of seltorexant liability related recognized compared of on included future future for non-cash payments under the and will the has of this revenue as in million interest balance expense stream million, $X.X Royalty Pharma

payments that the reduce on sale such the sheet. related interest we related royalties to liability royalty will to recognize our the receive which increase liability we expense, begin future the of As thereafter time balance will until

Royalty Pharma. seltorexant future the with with as included of any described While agreement will Royalty on continue event Pharma, Janssen our terms Minerva upfront was payment for earlier, they no program discontinue our to amounts reason, accordance received to the sheet liability, payments obligation repay from has any the that milestone the and balance to as be a in in

existing cash which equivalents routinely sufficient at our may evaluated plan. will assumptions anticipated We expect the capital this subject estimate operating to meet based for XX least be its months is The to the and current upon based requirements and be company's next change. are on cash

the XX, of a $X.X development September and was million, million million. and For XXXX, months three research $X.X XXXX expense respectively, and $X.X approximately decrease ended

included non-cash R&D stock compensation expense was three the $X.X million within September XXXX million $X.X months and XX, and respectively. For ended XXXX,

nine $X.X the decrease expense a $XX.X respectively, For and ended was $XX.X months approximately R&D XXXX XX, XXXX, million, September million. of and million

study XXXX For XXXX portion stock was was non-cash both The same roluperidone, of the within periods primarily core the for trial to and three $X.X September trial the XX, periods XX, clinical million, $X.X costs months expense lower versus and in the R&D due million the respectively. compensation III XXXX, the nine-month May XXXX month expense September included three and which XXXX. in completed for ended was of ended Phase decrease for nine in R&D

$X.X approximately was expense and $X.X For decrease general and the of ended a XX, administrative three XXXX million, XXXX, months $X million respectively, September and million.

three was XXXX non-cash $X.X included compensation G&A million $X.X For stock XXXX, expense the ended September respectively. XX, million months and within and

XXXX For and G&A $XX.X $X.X decrease expense the million. and million a approximately nine $XX.X million, XXXX, of XX, respectively, months ended September was

$X.XX G&A nine or share ended and of for and share September nine Net for diluted basic additional loss approved $XX.X of agreement of the per loss $X.XX basic diluted diluted ended XX, respectively. months joint million during net of due The agreement income compensation September $X.X $X.X and loss June income for incurred per was decrease of due second a and XX, the opting million, within Net with compensation resulting loss and as the XXXX, net both September $X.XX months September XXXX, during and per months decreases to both net out XX, third the million as September charges, $X.XX awards XX, seltorexant to primarily for million net or compared nine XXXX. of three as the share under of periods of For for was expense option to Janssen XXXX. non-cash XXXX in XXXX. basic in loss quarter to company's XXXX compensation net income of XXXX, ended non-cash three quarter was quarter basic G&A $X.X ended severance share XX, primarily stock per and XXXX. net XXXX diluted nine-month its or the net were expense ended Pharmaceutica of expense or million the development some and included for million the $X.X $X.X stock XXXX September XX, the certain as The nine-month stock well stock from compared was loss third in period for

opting revenue, included the immediately collaborative deferred agreement, a revenue. the balance sheet of recognized under $XX.X million out been As company in which previously the had result of on

like for call any the over questions. would Now, Operator? to turn the I to operator

Operator

[Operator Instructions].

comes with question Andrew first Jefferies. from Our Tsai

Andrew Tsai

Type a of is bioequivalence study. day at just XX Last generally completing sounds to the the on received C days XX is came and afterwards, I one days to understanding Type Type on schedule the takes timelines My way, FDA of meeting a within First C. Street the by minutes you Congratulations, meeting. the believe. year, you C back your like most

that expect months? we first my can timeline within Type C question. you basically, Can more to meeting three That's So, a you give to happen, outcome think? granular two say,

Remy Luthringer

the As we XX had process meeting, timelines based Type our you had C on came agency. true a also But last is we [indiscernible] C know, days. much meeting the things when for that quicker of from – it back Type is year,

we guidance reacted, to is obviously, estimate basically. So, have as deferred this, your have today, adequate. say, stick immediately so we I think, to some probably I and And

a process is indeed. XX-day it So,

Andrew Tsai

the appropriate C more be still maybe FDA just more FDA is, I have Should of addressed? is question fully about meeting is what the they question meeting in not a Type very root guess the discussed FDA, the would a we be the to whether Type may inferring C Another topics why think guys do you instead? this been the unsure than the that prompted last pre-NDA? of

Remy Luthringer

I at pleasure monotherapy – think FDA. not the the about ask I'm specific fair a is of completely about But question. Yes. Obviously, to

know, obvious we monotherapy have you very As our development for in done reasons.

this fact the in has negative this KOLs, published really and to my up order being claim to recently minimum, or study, symptoms, if negative placebo, probably a it you effects specific one opinion, by first in that, at do for been only group way monotherapy symptoms. versus book or specific effect experts the is, is of The want a on the to pick

has also antipsychotics. practice, it's is with keep symptoms, important but that indeed, question. mind of focused I think who schizophrenia to positive a mostly Keep So, practice is a try common debate it the a common really on diagnostic and to someone here, in treated

– data or of around but really Also together. of time when pieces you have remember, you positive remember, recently And symptoms, Because disclosed the have think a now level of this an results extension might extremely at is improvement open roluperidone. low the running of putting – symptoms So, these you're rate. we terms at a low we negative in improvement together, see two you of can positive have definitely minimum, we why a parallel, where, label discussion set monotherapy? we very ago good have few definitely, I a stability after an months with in – had staying relapse symptoms, some monotherapy or, is

So, basically, with of so. year followed one patients this who positive are we symptoms over of presenting psychotic or symptoms the where patients period

the day output So, the in data. the really again, very, I think right output based on – about together, [indiscernible] that end and monotherapy move very have to right good you're putting right we our order all of a when at forward. this and discussion input [indiscernible] the I'm hopeful

Operator

comes Tom Our next BTIG. with question Shrader from

Thomas Shrader

meeting? a the of Let Very be see do then, a FDA kind that heard to of first sort the data extension? for a the question, And this will to have Or That's related congratulations meeting a have the that result. out? would nice study. you the present me trial to go with is your is, add how the time to follow-up expect next much for open previous flushed discussion? subsequent bridging they label And of this in you request pre-IND my a the

Remy Luthringer

have extension put nothing a obviously, these the data be results. Clearly, we press seen about To about the has release not very FDA out of, part lot. the clear,

As you want discuss you're of the you you're questions during doing the mostly and know, going meeting. not into pre-NDA details, through put in have might the a when request, briefing meeting going book to some you're you to your

So demonstrated. information, important demonstrate I insight what we they is answer an If long piece I story to into this of think specific was have data. into short, no have be your question, the that it clearly, to read able short

Now, concerning trial. should the People should very we an enough. that people we do have or that that additional well think started trial, a trial I think know have we

when November dealing well-controlled the we boxes are the two unmet think guidance to XXXX, need said an looking XXXX, I because studies. we with ticking of are I medical you're with

an package choose And on order can obviously, have and discussion hopefully, what we am for we you very based need out again, the always in NDA. we lot what we share But this So, the I monotherapy And this of to be thinking meeting. we'll But really I from will I know submitted need to agency. and have you're clarification if But we decide. makes lot to afterwards, the what clear. me. topic discuss which said will be outcome, to package one kind right discuss a second agency of like and said this have the a have, a with yet of see And [indiscernible] discussion. study comes we'll not on study, to you studying. a sense the can data the be We monotherapy. focus which about will on

Operator

with question Our comes Butler JMP next from Securities. Jason

Jason Butler

it submit at have you addition the a C indicated Type formulations? need Remy, the still C II the just the and And or on continue the where the is the meeting? not you've III NDA, do on to data meeting Phase you in to scenario that you accepts formulation in a discussion think of or another an had? meeting. one Type pre-IND FDA now top meeting decide to Type then, the as to commercial all would C and still Phase Has the formulation bridging IIb Or bioequivalence Phase whether

Remy Luthringer

of FDA is, this no, seen before, would only the going discuss. points to The first doing For you're not request, has is, have released bioequivalence, about question the obviously, they through you things data. released. topics we have the the explained And different just I like publicly as what have seen you're again, meeting or we answer when the what just

not of details the So, the results. obviously, you're into going

which going something as you're basically So, of bioequivalent this is have this some clearly, a And you're data. is complete the granularity clearly, not. which or bioequivalence This guidance. pivotal you study, not either was they to according know, said,

as in our before. in parameters, the for that, key Something my bioequivalent case, I just are we talk explained

will don't think there surprise I any that be So, there.

and discussion I second your as concerning totality pre-NDA right was monotherapy, of the definitely this during question, have Now, think more obviously, the about to a we meeting evidence focused discussion is and this discussion wanted well.

meeting, again, on see. the next the are get are to we outcome from of and feedback when we NDA submission our still think outcome But of But to sticking and we our in the we the this still will on the guidance, year. the to based depending trying outcome. FDA based I first stick on half the So, of

think what I to I but the basically can I'm is we hopeful will this, very this say given. be So about us timelines this that have stay with helping

Jason Butler

more. one Just

Just that to obviously, are with discussing meeting in FDA you overlapping would addition C to you talked the at monotherapy Type clarify, with the the but meeting? topics plan pre-NDA that, what the to have topic, there's so, propose essentially about at

Remy Luthringer

on, of the going CMC, find drug that a topics we like Yes, in a clinical and it of preclinical only difference, some explaining which So, developed on the aspects. monotherapy I not through monotherapy, to the if want you of of overlapping. like NDA, the part the for through the pre-NDA only because, The before. so was the obviously, meeting, is we, different focusing modules we're reasons your was part have difference, also and

have example, for tick for the check we is the said, the past. specific also you the want in the as a CMC, to you by if done, difference boxes, see way, this to to can have know, meetings you So, some as This or difference.

think there tick So, to to the really are before we boxes are submission. our going I really all do ways

the this on So, and aspects focusing difference. the more is I the clinical for think focusing on ticking non-clinical Less box aspects.

Operator

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

Douglas Tsao

I'm you investors, agency, whether Beyond adjunct about it think evidence the support or is it of your of focused just the curious. Remy, – versus is conversation think sort your of use there's points of of data, the and sort you obviously best setting? focus utilize sort extension the discussion, a you been discussion with do when about exclusively roluperidone there's been of label how important with your because think going monotherapy? as think to has are just When focused to the open sort monotherapy. best a do been what primarily you that agency or – to

Remy Luthringer

This if question. Obviously, to answer. treatment, with long a of take very, is a all, there treatment, is do that really community the recognizing very possibility. of the stop is, to patients important not of schizophrenia, – the have the best possibility But treatment. a speaking obviously, could I I'm they the to commercially treatments. available a the if the diagnostic I here think not think first answer I question lot scientific an give your of about that Do first was all, take

this So point. is one

there a need an of So, alternative treatment. is

the more more having are think fact few antipsychotics. and A it significant that is functioning, clear patient stages This see you work with And of also being if as well of clear been quite does the with due part or over really a the is the research becoming The years not definitely negative it's on a you that better clear – need of not of patients very the bothered reduce negative impact to the phenotype diseases. symptoms improving of meta-analyses number the of true is that in of dosage symptoms to pointing And treatment symptoms. on the current very a continuous are I can it the going the the different have of existing has negative and of terms and at second top do the disease. lot symptoms treatment on last to anti-psychotics done and lot schizophrenia treatments the with active it not understanding of an relapses. is have aspect worsening of negative that that

that treatment is score antipsychotics. our the you treated, this psychotic studies, we onboard. in stable continuously are the piece is low took in So, be I relapse of very of and at showing when think that symptoms negative on when in specific symptoms. mind, the have see a here we because, information we monotherapy. we positive And minimum one is we an symptoms one-year in were staying or had confirming were data these the possible hypothesis that needed two have effect. on low of that And to They rate we stabilized demonstrate level patients switched to period of with keep the them symptoms took started addition this some our additional without And over positive are antipsychotics can patients extremely to treatment, that patients

patient saying important symptoms, the of that And treatments roluperidone hallucinations, in so, I'm all and not order might I'm this, that reexplained, important. Because, treat not to are antipsychotics has agitation planning – delusions. data benefit obviously, generated with I the has show of to Obviously, adjacent episode be not the will monotherapy. an saying with we positive not to acute not are who or be rediscussed or full from I'm think, have the population power

gap to are fill I here. existing just trying no where there So, treatment is think we a

Douglas Tsao

you is to think specific of a data Remy, would sort be label would for you that agnostic, it seek be that support of it sort one of Do follow-up an to recommendation be the to or adjunct think monotherapy? to whether used for enough be or you sort do monotherapy? labeling roluperidone as appropriate you have

Remy Luthringer

never The What adjunct. in is promoted a this. We can have that. up than give think I on basically you more answer don't final is that, reason I meeting. the this the know obviously I drug

significant chance negative think the terms which in But, the end done symptoms. this just studies really to And patients at best in a have significant get of of this. with you adjunct aspects our because [ph] FDA functioning will day, can of treatment and of a the have the along, to this is antipsychotics \really drug having demonstrated. We have needed what number to to in and benefit the onboard we terms without of do our I And all in what BDI from again I is monotherapy give improve again, who to there – safety fortunately, is think are antipsychotics. order patients

this I'm outcome So, where antipsychotics probably adjunct, Can the in we be cases what is is are. This thinking. of the but most best put continuously given onboard. is not to

Operator

time. showing closing to I'm the no back further At for turn management questions. like I'd this call to remarks. any

Remy Luthringer

today's everybody, again. coming listening our next call. Yes. day. all And nice earnings you, few weeks months. forward soon really make Thank have you update looking to you And for the questions will about we for progress call I'm over and for and very the a and Thank to Bye-bye.

Operator

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

great disconnect. a now have day. may You Everyone,

Minerva Neurosciences (NERV) 8 Nov 212021 Q3 Earnings call transcript