NERV - Earnings call transcript Q4 2020 | Minerva Neurosciences, Inc.

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Operator

Welcome to the Minerva Neurosciences Year End 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. on available at quarter Eastern company's Time financial with can press section X:XX and year be of and found website. results became end XXXX Investors Good fourth highlights business today, A the release and the our

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

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

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

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

Remy Luthringer

forward Thank of Phase good results our Thanks meet very this which that for symptoms months full portion roluperidone in negative half schizophrenia. report from present year for double-blind signals an I'm progress to pleased We did us Phase and on encouraged with available significance. joining today. you, remain year. update emerged. in the We morning announced study earnings to statistical look last highly we May promising data be trial the open-label sharing the X of from XXXX. first everyone. not line top Bill and by of the the year will the extension, the In nine Also X

the agency. meeting C Xb to in be NDA Type the during us dialogue FDA on Phase cautioned Phase would our with the continue the then be that with an highly our November submission we data from Following XXXX, current studies filed, FDA likely which X and the based

the to our well Phase manufacturing. as comparing one designed volunteers, commercial Furthermore, information Phase facilitate employed on with the FDA in trials, scale X minutes. Xb the formulation partner, also in approximately are in study we large supply as providing We and conjunction new topics XX at Inc. least formulation to pivotal highlighted a the several healthy initiate will with bioequivalence meeting Catalent,

encouragement committed clinically patients to We possible as in of treatment. symptoms, negative by remain is are the the requests agency's We of comments to are roluperidone address treatment the and schizophrenia. negative advanced. most we FDA's much roluperidone to such Among the need quickly emerging therapies in roluperidone development bringing symptoms working for development elated of to continue of for and the as

we to are XXXX the with our subject Royalty certain million following further $XX achievement to from forward of recent royalty will We the million which milestones. and receive cash a to $XX to the Pharma position seltorexant of significantly rights received improved sale upfront looking we

would update on which a potential provide detailed our symptoms. to treat drug a I lead First more roluperidone, like negative to the program has

objective roluperidone. continue primary in Our NDA requirements, meet to an develop XXXX path to submit is forward the regulatory to for the

extension that enrolled the First, weeks the a nine entered ago, months XXX completed on and X of to been was already received schedule I dose due trial patients with nine double-blind on treatment months Those and or The happy phase mg. who total to XX double-blind received being discontinued which the on mg. open-label the treated in randomized patients few those XX% COVID-XX either mg of open-label report Phase in those extension no the of patient am illness. XX-week same remained has XX-week placebo around were roluperidone to phase mg XX XX in patients the XX

total when the continue maintained necessary the I the become improves XX%, of improved and around positive completed activities to profile and whether In to sustained the symptoms to whether we sharing of half of tolerability submission XXX or forward move over the Data one-year data expected of extension presentation roluperidone forward the safety the look parallel, to increased the Phase of is they with symptoms a roluperidone months of may open-label or administration We symptoms the one-year and/or over Application leads available. Drug duration, New negative support functioning, maintains because extension, negative are agitation, Xb available period. be in XXXX. study. findings demonstrate improvement the are is roluperidone. observed we to a detailed in six pleased important data The patients, for if is as of that first very of if improvement

the to intend we First, study earlier. initiate described I bioequivalence

will that Xb believe FDA made formulation. showing specific we the the about across by the we bioequivalence Importantly, by comment formulations, address Phase

the support Second, clinical psychometric we properties in as in of FDA. submitting are development the in secondary requested the by our key of and literature the the requested process primary endpoints used of scientific

completion from open-label certain for now program. will data the the the the pre-NDA to FDA potential study, data and the the X from bioequivalence I negative of Following we including the treatment of submission roluperidone to a of recent schizophrenia. in bioequivalence NDA on seltorexant move symptoms of matters, Phase with request pivotal plan meeting study, discuss extension, the developments

You the Minerva will of agreement exercised out with of mid-XXXX joint seltorexant. in future Janssen right remember that development to opt its for a development

costs additional collect Royalty Minerva Pharma seltorexant to result, XX royalties we interest acquired & no with of in commercialization development sales by royalty announced upfront entitled Janssen symptoms. certain major the Johnson treatment worldwide Pharmaceutica, payments to financial of development on on received the of clinical, with receive regulatory, $XX and this a adjunctive million contingent further Janssen. On up had that $XX Seltorexant indications subsidiary that million we further in achieving As X milestones. are a in is January contribute currently and Johnson we certain future potential to year, potential insomnia to of in payment obligations clinical an to disorder Phase with mid-single-digit for depressive

dialogue months symptoms remain studies treatment non-dilutive well the in forward a our top that I with as investors treatment asset. ongoing as lead performance. have the data has as in the in us pharmaceutical our pivotal the from Royalty soon now committed secure extension It coming the of and Phase of the sharing funding, our I you the we long-term, schizophrenia. to We roluperidone the significant In the with over bioequivalence to both negative potentially open-label science will FDA. royalties to to summary, the look of life Pharma, discuss with acquiring our over developing partnered enabled will immediate Geoff potentially the industry. support financial are priority, roluperidone, across to turn continuing to delighted transformative continued update X and on to leader development

Geoff Race

diluted. to operating estimate requirements million December which related company's a for and million In cash a share the received quarter XXXX million results payment million at with for compared the upon secondary a and $X.X in Phase primary ended completion and report XXXX to loss the XXXX $XX.X in to failed on the from clinical $X.XX from December $XX.X were respectively. Phase XXXX the Xb Non-cash agreement $XX.X in million we morning, XXXX. in the impairment of the were ended million Expenses year December respectively. XXXX Research fourth ended in compensation was Company’s million fourth G&A to December XX, years issued for for XXXX loss of found for the payment XXXX. routinely this our restricted existing by and compensation include filed and the may of the cash for of expenses least XX, $XX.X fourth company's to per net The December in our decrease in were quarters for due company $X.X operating charge equivalents, XXXX. expenses quarters XXXX key or respectively. million at $XX.X Remy. December of respectively. XXXX, expense XXXX of trial $X.X end the the for the in respectively. interest MDD Janssen Net $X.X in you, and Form-XXK research roluperidone million MIN-XXX due included for $X The due and ended plan. trial lower XXXX. expenses Thank January revenue ended XXXX insurance compared the out $X.XX costs. in the in stock of following year included in to million SEC for and the and received expense and will and the of capital expect expenses ended of G&A share basic was which The of of and year results XXXX December Collaborative and results per in XXXX diluted offset of discussion approximately and XX, our $XX the as Earlier opt December XXXX million, change. collaborative XXXX basic or was XXXX, next were Net and December were the XX endpoints. XX, XXXX and XXXX decrease expense million be and pre-commercial in based approximately from income was Phase quarter be fourth per to right years G&A is XXXX, year and based its detailed Cash, royalty higher million on today XXXX, its the respectively. today. loss of trial $X.X as million decreases of with respectively. December $X.X basic diluted, MIN-XXX and December Pharma for was press diluted, was net and and connection for development for co-development to XX, loss acquisition evaluated results $XX XXXX fourth the expenses May Pharma the primarily expenses years $XX for also or R&D summarizing XX, during meet and million the years year of compared The months the $XX.X the X Xb anticipated assumptions of December income our and of ended XXXX December the to expense ended with financial development clinical R&D cash the $X.XX to result A R&D ended double-blind are process combined XX, XX, in release and increase current December of basic million cash portion XX, XX, of G&A $XX million XXXX XXXX. quarter XXXX expenses meet was fourth quarter the was $X.X share XXXX revenue maybe and years more its the of subject of ended Royalty $XX cash for $X.XX million exercising completion R&D or loss per quarter December for annual $X.X million XXXX XX, January year XX, seltorexant. fourth its loss in of our ended Royalty XXXX, that equivalents, taken primarily and million $X.X share million the a the The sufficient million which $XX.X this We XX, the of earlier the the the presently $XX Non-cash $XX.X were and to million stock from with for

a and out, included recognized Company balance million performance on has deferred no $XX.X revenue the further result its of been of had opt under As revenue. the previously which obligations sheet

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

Operator

Tom Thank Instructions] line Our of question BTIG. Shrader you. [Operator from with the first comes

Your line is now open.

Unidentified Analyst

on fair the from meeting? analysis detail? the package may is to there Julian FDA extension or some assume the for Thank will I'm from the in my got you points your wondering this this for pushback And the is likely recent bioequivalence is NDA CMC to Hi, address gating be Type it C questions. could you last on the if filing the data then that of share are be step study, an any open-label taking specifically upcoming Tom.

Remy Luthringer

here. speaking Remy Hi,

questions. I us great you extension need because be re-demonstrate the you is very encouraging data I over yes time. symptoms will is of the really think, disease are know the indeed as and a effect mean sustained chronic you to part right, to obviously really negative So that

So check from again efficacious Phase we to I because really already mentioned the I looking my mean Xb. in presentation, we forward as are data have

we XX remember of months six top of double-blind the or months Phase. had extension you If three weeks,

we So improvement we've in also in continuous study improvement and of this functioning. negative see of seen terms a symptoms could

the to all, improve. mean of first to will So symptoms confirm I be continue we able that negative

again, a is important that what functional patients go functioning Second, is life, as and back have that to function able job, family a then so is and important. can are is to decent into a you transformed they these that improvement really to know, extremely

PSP data year. extension of check nine along will and because be one all we So have able of this, to will are we the extension, the so PANSS months measuring we

I relapses is of can we box to so the We we this Xb, be to to what will exposure you months drug, we last obviously we symptoms long-term mean extension this will really going safety. And check and data, of least, confirm if limited of call as terms positive check as know, to will check relapses to we our had also also have terms in see in be on what able yes efficacy the place number important. very be Phase put about and not the of in so but XX but also safety, able in

formulations, the and If So can indeed, really the I in time between remember, also so placebo towards if in it this controlled, for this this blinded have the study no my second bioequivalence yes think longer important the mg is opinion And some pre-NDA but again ago preliminary we extremely indeed important demonstrated check is to about study, moving we meeting. bioequivalence still yes of between data think as study. different I question driver did the the is really you it and XX is for dose, mg. XX really we possibility your will

Unidentified Analyst

you. thank Great,

Operator

Thank you.

of next line Securities. Butler JMP with Our question the comes Jason from

is line now open. Your

Jason Butler

outlined taking on A trial open-label the the patients sense as that the just a over in Thanks. are thinking couple then we in Hi, it extension? And medical you the into double-blind from releasing you you release? could give many meeting extension, open-label the analyses the of get a finish data? you've how questions. can the with rolled you us secondly, how arm placebo thanks about the data as for release of Will soon press the conjunction or

Remy Luthringer

Good Jason. question,

think equivalent extension arms. in treatment phase, it I the of between was clearly placebo the went So terms who into quite patients mean I three

is because into important of think, data be going -- the of of of about I think this XX information extremely I or switched because piece data convince I to the this more placebo same we had think extension. I So either it when happens less patients I everybody, molecule. are our hopefully was an will able additional who mg And they is efficacy number what this XX the to or

think they announcement of I important. at about this specific this are because event a will release a have so specific data we

will the as format data soon about the communicate we to we the best data. as available think have So

Jason Butler

and on or the then your analyses more excluding without analyses, interactions with updated on accept any on thoughts the the advisers Remy one FDA Great agency's single that willingness -- mITT or outlier just to the site>

Remy Luthringer

a from know of have as confirm more will data to is really So, mean data already FDA all they the review it the matter you some because yes, is I we was the go really should really done. not XX been deeply, into I will check it how mean this of of done as these assessment I mean site, signs have as efficacy according the well vital that patients to, assessment

looking particularly have a division, I ITT has been moved you're by what of with lot population. forwards NDAs of mean, the lot files, past when to, a the done So modified in or psychiatry

so very So, the confident patients mean be XX considered. clearly data, population I not with in should the carefully again the where reviewed having I that mean, FDA, the there after are ITT are be I happy were precedents and we to modified analyses mean, I a mean,

So, to what out from came mITT confirmed they Type and ITT is data. basically, based matter and of C this a they on the meeting, willing consider are review, really

Jason Butler

great. Okay, the for taking questions. Thanks

Remy Luthringer

you, Thank Jason.

Operator

you. Thank

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

open. Your now line is

Jeet Mukherjee

is morning, Hey, Yes. good Jeet on guys. Biren. This for

on ahead me, improvements group open-label that status? from we of or to neuroscience of the Just the a data, IDC in in with Thanks. of to in and perhaps point PSP patient that as a specific excluded performance going modified extension or on such see data CGI-S analyses endpoint included that are examples of Remy, point. terms patients? And the approved being make just kind couple went any are that again of questions ITT space modified agents there actually

Remy Luthringer

mentioned without mean, are accepted like modified I space there division but ITT mean approvals population SPRAVATO, as have approvals I I been the like definitely, just before, definitely [indiscernible], mean, into and by of mean specifically a I you and I going is so the mean has the psychiatry details, as in psychiatry where precedents. the I FDA. as have you Yes,

So again, important site, comfortable plausible I is did data. gets are with provide site not this is think special we that this mean, I FDA something here. the not that doing what

this about this. So what is can I say

second you you can [ph]? is repeat point were the So Sorry, the suggesting question? what second

Jeet Mukherjee

data was patients' data extension and question just performance? getting we'll about to talk just perhaps getting, we the open-label second the PSP Yes, on are CGI-S be

Remy Luthringer

Sure, for sure.

I I during open-label to as mean, continued PSP, so and parameters, measure mean I So PANSS, including mentioned before, we the the all CGI-S efficacy on.

And so to able to definitely, demonstrated the indeed, improvement I yes we linked we as this. And is really improvement think be negative will very of to we will that already, symptoms. re-demonstrate, have PSP the

remember, again, negative significant in is coming, is also total you this of double-blind abolition yes. phase, have we will was indeed, score have all the we will already related improvement If it we symptoms there. the specifically, functional more the wherever from and data will analyses PSP have But to

and So all presented happen yes. be this will will definitely,

Jeet Mukherjee

you thank much. so Great,

Remy Luthringer

welcome. You're

Operator

you. Thank

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

Your line is now open.

Joel Beatty

Hi, thanks for taking the questions.

show commercial comfort is then to FDA? different what Phase along the that you could plan bioequivalence you one you X, study for us plan be First tell the supply? X, compare to in with also the and three us in from bioequivalence. formulations Could what to about you on And comparison, then, help in differences Phase

Remy Luthringer

demonstrate because parent are the Yes, Cmax. know, the to PK/PD or is here doing the at AUC mean, is from the are to exposure I same, AUC, that is the to of different trying as I drugs drugs roluperidone coming so compound or when the not mean, all what we I of related the so past, again, exposure mean are efficacy the formulations of as mostly the to efficacy and in and it I you're the the mentioned analyses, you

really analyses, in So, key which people this by this space. specialists is extremely some PK/PD who clear done from our external been are of have

but the reduce between improve even Joel wanted to we safety remember, preliminary if further metabolites, BFB-XXX, effects margin Cmax study try because achieve of you the QTc in wanted which we parent showed, Phase one -- to of compound event Phase we the the to PK this prolongation. to keep Xb what of So AUC goes terms and the and X, our on

Phase has this Phase X show kept reduced this X to do our Cmax we we in a and this we at some Phase that I So where major mean, of parent formulation, this could metabolite. all ingredients just able should and formulation and one difference it. of webcasts some change bioequivalence. not of is between and the we were between AUC the Xb final we It and the Remember, and BFB-XXX again is No, changed. nothing percentage is presented

this completely to final information it confirm is already by is is a we between Hello? which and produced as Phase ready and I the formulation, So once X currently more Catalent. comparable have that mean

Joel Beatty

that one real on the Got it, is exist? those thanks. like get patients something question And mITT be to then is there kind that other of may patients, XX not way actual any data for the does or from

Remy Luthringer

to you what actual me by you mean Here, so… data, real have explain

Joel Beatty

guess, I Yes, they, sounds was doesn't so the like that readings. reflect implausible actual data it were it

have were So example, able that readings actual patients and were dosed those taken? assessments been for confirm, to and you

Remy Luthringer

No, I Sure, understand. sure, sure.

doubt it I mean, just baseline. Why the carried for, about is it a also I been exists. is for efficacy data no definitely, and have lot signs there some from the vital patients that is So the again that of think clear forward

over is no mean, which and time yes. I is plausible, I modification some past. there clearly, in data the and this examples completely mean I of gave So, so

the done I patients not assessments exists, but clearly, So in have yes. been way, mean the right the

Joel Beatty

Thank you.

Remy Luthringer

Joel. You are welcome,

Operator

you. Thank

Blair. the Our with Myles next question comes of Minter from line William

open. now is line Your

Myles Minter

and the my background apologies taking for noise. questions Thanks for

question. be the But that current actually a would analyses in the process they're the meaning of mITT format out unlikely sort by for accepted its clarification be to same, that believe of review. to filed. that NDA of be be a stating I top Just the would FDA

get wouldn't mean review. a it that So that would

the and to was was the recommend am interpretation? ticking set filing So of missing unwillingness that in And to you have hand the now didn't that you're fact safety correct question acceptance open-label on this [indiscernible]? filing is completely that due you have or boxes there I the or and the that place my Thanks. everything then just data is,

Remy Luthringer

extremely gave the So, what organization we terms exactly we I and an as is of received the mean, transparent you know, minutes. in Minerva

So, means this is points. clear data piece not roluperidone and answer to label one available It hoping of open-label is data that efficacious that open the that really we drug. the is your main are this at additional of were information that an time will be an confirming

FDA demonstrate is why bioequivalence, can reason what not And, if to our to mean, shows also when I mean, data of able move of I end through I guidance after, guidelines, these this according mean, go preview, go I go if the related level this So will the this goes this review we bioequivalence if and bioequivalence, from will mean could outcome. said you is I If Xb XXXX. this obviously of mean, so us. we convince review, I think about processes, really that study, are in If to don't an is you studies the I the we mean, to advisors I the your one is package. to Phase the Phase the our are data, Xb efficacy what have which two see a being FDA this make you to telling

open process. information gave the dialogue PSP. of of we I total the them score how presentation a FDA. dynamic with having psychometric calculation the aspects the my a So, really mentioned are in We, scales. I the I mean, it's, We the as managed them, we of about We different think gave

confident a data, a think and our doing in continuous positive extremely great we FDA, that better will and them, have is we able it's will and from if So analyzed the NDA. we be job a I the dialogue way what and in even hear with mean, data move the we're forward to explaining I I'm the have

Myles Minter

XX. us, question around I on last And you that for is added XX just the much. and up additional that helpful. in to an formulation patients patients that talking just other is time for about very second the now that's reason very understood was study, trial? or the it's to cohort Yes, were bioequivalence my gone commercialization about Is the Thanks understand some it

Remy Luthringer

Yes.

power ends when subjects. we the I real it have calculation, powering up about calculation I together spoke sorry Myles So with and XX No, mean, speaking guideline. we done was

safe So basically, going patients are here, because subjects, mean, dealing is not having with healthy subjects the to side, we are more healthy we with I or subjects. it

do and I So it's period also the know, you is some so but know the as is go, want drop And XX he three. job basically crossover own to indicating obviously, number the here, not that this his a is -- control. is a powering trial, might does healthy outs, to you because whereas mean subject have never you because body finds

are in out. two power calculations, or including maybe and our one So clearly, subjects in anticipating and drop or also our we modeling might

So on to it's be the safe basically. really side

to done constructive and is any also in feedback, and mindset they you, open that we have we I interrupt very so protocol to waiting, I have something mean, again it's very -- are definitely we the important Sorry FDA. with our mean Yes, but the if FDA. a submitted

Myles Minter

of lots with interactions Right, much. FDA thanks the for looking the data, so and very open-label

Remy Luthringer

Thank you.

Operator

Thank you.

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

now is open. line Your

Douglas Tsao

taking the thanks and for good questions. Hi, morning,

Remy, we're of the XX data to mg the for going get doses. in terms Just open-label XX and extension

of sort more of consistent make molecule in across sort studies you've going that thoughts honed the you. the do that anything terms would see You've XX you now. revisit Is you're the of of there Thank effect could seen you mg perhaps -- in of on XX sort from the for sort forward? the mg that

Remy Luthringer

improvement, mg and very you're X, larger and end mg I a so have remember that in I different the of combined again not also you're the the are effect was sizes. integrated I integrated, X it very Delta Yes, Phase not looking think the or mean, improvement. When mg the why could XX Phase double-blind when When clear the mean show had size we showing highly was the because speaking placebo in really significant Phase XX value Phase placebo. I Xb we mean day. I on XX Obviously, is with a definitely at for it Xb have decent that the to is I up doses two I mean, nice means from given I’m mean, looking effect p data reason

an a year, but this the mg is of shown I’m be one clearly is I important data of the a mean pharmacological I XX dose. XX I mg towards I the extension dose. still think indeed, has final over which XX of pointing saying have again, So NDA, continues that we that if mean fact period the mean, not filing to that are symptoms effect, negative part will improve

the and with doing So pointing have of analyze data, let pharmacological clearly the let is that XX improvement fact XX us we're mg, of the but will showing an towards always us what the patients. data we a see effect

Douglas Tsao

some your And in focused makes just PD follow Thank terms is sense. not curious what of made analyses just really AUC you. you confident markers in I'm I'm you you. up curious, Thank you great. that that as markers. referenced effect PD on? Okay, a the which just Cmax,

Remy Luthringer

on For to the PANSS analyses, mean here based definitely referring the we I negative scores. I so was really it PK/PD negative. are mean, PANSS

clearly, to at and negative improvement what exposures versus AUC is coming we all score, it negative is exposure explaining you're did symptoms PANSS. looking not the versus from out PANSS of So when -- plasma the And Cmax. as

the between where from analyses. making pharmacokinetic So this very and PANSS different a very, it's, comment. this is compare parameters. mean careful I in It's I'm parameters

Douglas Tsao

you. great. Okay, Thank

Remy Luthringer

Welcome.

Operator

to the There questions. for call back turn I Luthringer will Remy further closing remarks. you. Thank no now are

Remy Luthringer

you to take for these questions. and you I great thank Thank this opportunity all to X also caregivers thank families so really, patients wanted much. and have Yes, everybody Phase this to participated study. who

have we weeks, went heard, XXX mean I end of of patients. than the patients so more As these XX the some to

hopefully which this you one to help, an for first symptoms. be again drug, thank treatments So the innovative will develop negative of for extremely

on to looking update So the open-label bioequivalence forward data. upcoming data I'm milestones, you and next

with to looking and speak again you Bye. thank soon. So forward you

Operator

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

now You Everyone have may disconnect. great a day.

Minerva Neurosciences (NERV) 8 Mar 212020 Q4 Earnings call transcript