Earnings call transcript Q3 2022

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Operator

Thank you for standing by. Welcome to the Minerva Neurosciences Third Quarter 2022 Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, today's program is being recorded.

like Executive your Officer Vice Business would program for and I Officer. Race, Geoff President, now, to host introduce today’s Chief And Chief Financial ahead, go Please sir.

Geoff Race

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

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

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

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

Act results Securities company's these cause and the Before actual Private would forward-looking provisions materially prospects that to and are discussion for future Litigation that uncertainties we constitute subject statements you forward-looking that the under of XXXX. remind risks expectations, like to Harbor I those from the to Reform Safe We statements indicated. plans will caution begin, today's purposes may differ about include that statements of

a SEC with the for the forward-looking of more on XX-Q ended are filings current to expectations quarter XX, statements SEC, report factors may materially caption under from including results the due fully our filed These that differ detailed Risk Factors are the our with quarterly Form on XXXX, actual and based earlier variety in today. our September

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

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

Remy Luthringer

morning, good and today. for Thank us everyone. Geoff, you joining you, Thank

XX, our Xb two schizophrenia the X submitted trials and August The studies, of in to negative roluperidone treat the with we NDA we Phase schizophrenia to clinical included data symptoms. symptoms XXXX, on from negative in patients our diagnosed for reported FDA. previously As submission Phase with

and double-blind of trials for two these administered included NDA. that and purposes results controlled each well The are the milligram months and from studies to believe both XX an milligram study. We XX the extension Phase was Xb doses to of included adequate extension and X the in the overall open-label XX-week data data controlled. from set the placebo submitting nine Also open-label duration, study data from six months Phase the

by data We also FDA. the additional provided supporting requested

A we the for substantive the our to letter a requested of Type to receipt have in the refusal meeting FDA's file discuss October, NDA Following the reasons review. for from FDA accepting not

Type the We expect A to year are end and available XX of the meeting days occur after before minutes meeting. the the this normally

NDA roluperidone. would regarding I a comments few to our for make like

negative symptoms the that note represents to in which drugs drugs important unmet is and which are direct of benefit it to First, no huge to a a clinical studies, Furthermore, treat symptoms knowledge, or no have there there U.S. the my negative on in are specific developed being currently need. approved schizophrenia, schizophrenia. of medical

that two specifically of It drugs been have of by but as patients. to down development true improves severity negative positive our affected is roluperidone improving shown Furthermore, symptoms the have bring of be and functioning studies antipsychotics, none demonstrated effects that negative reducing in directly the negative other overall symptoms, of disease side the a symptoms and related symptoms. function on (ph)

pathways drug patients. which over negative which this may those only block scientific related. not effect it Again, above symptoms to of the is literature which related described Last symptoms, in drug, brain drugs that knowledge, shown roluperidone in negative my well cause has related is and in dopaminergic but least, the are the worsening disease antipsychotic

with lead do suffer diagnosed semblance patients roluperidone difficult this of yet to not with subset it symptoms start, for continuous Considering negative large treatment need still patient from factors the of for make a a is developed schizophrenia as some we antipsychotics symptoms monotherapy that there a who of that believe these positive all life. We normal sub-population.

practice, there have these number and clinical in is our worked I in studied Having significant community, the know whom in a trials. patients we of recruited clinical

treatment medical look acknowledged need reasons following discussed for FDA to have sub-population not the that discussing forward has a previously at the the provide our negative Type and we'll the of unmet U.S. A specific meeting We update symptoms with an the FDA need. a for We that meeting. for and patients represents FDA's accepting NDA this significant

Fred will I to update. financial the now for turn it over

Frederick Ahlholm

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

of were as register Cash, million XX, In of registration as million XXXX, in to to approximately on cash $XX.X to $XX.X equivalents the million compared $XXX S-X shares September we new stock. restricted Form filed XXXX common up and September XXXX. December XX, shelf cash statement of

and time-to-time open entered LLC method agreement permitted sell market through law with Jefferies Jefferies an deemed also and offer market the pursuant of offering. common shares we may at to our sale stock by by We to be into which from any

stock ended agreement. September our of issued months were XX, under XXXX, nine common no sold shares or the the During

September eligible registration under As statement million was XX, S-X. aggregate for our $XX.X of of effective an sale Form on XXXX,

on XX plan. the the that be sufficient months equivalents at company's cash will based cash to and capital anticipated operating expect We current its least meet for our existing next requirements

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

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

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

non-cash respectively. decrease $X.X R&D in compensation XXXX, XXXX both September for and periods ended For expense expense month XXXX versus nine and the included the XX, $X.X and was comparable XX, R&D stock the The nine million three September in Phase months million due submission the was lower offset in costs trial to open primarily to consulting periods roluperidone prior due in X completion by support of partially of the XX-week XXXX, XXXX. August for NDA higher the in year label fees of extension the clinical ended

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

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

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

September three lower XXXX, million stock was million and primarily XX, non-cash included respectively. insurance September expense and nine due in periods ended nine expense legal costs. months the in period prior G&A was ended XX, decrease compensation for the XXXX, $X.X versus month the and The XXXX G&A to year both For and $X.X comparable

the and million For XX, respectively, $X.X September an three increase of of ended million million. XXXX, months royalties $X.X expense was approximately interest non-cash $X.X XXXX sale for and future the

respectively, expense nine the $X.X future For $X.X was approximately months and the $X.X interest XXXX and XX, million royalties XXXX, million. increase million of an for ended of sale September non-cash

upon the as three which and rate period royalty The company as XX, entered timing of contain sell XXXX, Pharma, the from which interest interest to Royalty totaled of at effective XX, in the be in for September accruing royalty amount XXXX increase estimates, primarily an the expected date both increase year periods our with underlying seltorexant payments due XXXX. The the the at versus was interest based $XX.X is January nine into interest over well an balance ended and prior expense non-cash assumptions liability, million to agreement the significant to month recognized regarding the milestone royalty to which September effect period. in XX, and

basic to the was loss Net basic $X.XX was of quarter per per XX, $X.X nine share September and per September as XXXX. diluted net of and $X.XX diluted $XX.X or loss compared $XX.X ended as loss million share the basic of nine $X.XX XXXX, loss of of and million net loss for XX, per the million loss ended third loss diluted for and net or quarter diluted, net XXXX. share months compared net $X.XX for XXXX the or Net $X.X and million of third months share loss net for of basic or to of

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

Operator

[Operator And first our the from of Andrew Tsai Instructions] question line comes Jefferies. from

Your question please.

Andrew Tsai

updates Hi. having Thanks Thanks and for sharing good morning. me. the and

juncture unfortunate. we the Can you So this feel at the does previously RTF infer prior any of Type despite comfortable C which FDA your about in meeting. outlined issues now whether the they received, is that

you. Thank roluperidone And a ex-U.S. the mITT, So then monotherapy? I the as a the even have follow-up. formulations versus or U.S. endpoint

Remy Luthringer

question. sir. Hello, Yes. Obviously, great Yes.

have So yes. the I meeting I discussions achieve and have something you obviously mean, you you think, a with time each FDA,

proposed has this So type choose said, really meeting after to file. we FDA something else think to that have I because the this

because so we they Again, during in the and this discussion the we would achieved happened will has we very what a and will has think But have mind meeting report we to more dialogue, to this so the few like look discuss been an good after see I meeting. not hopefully been have And like, has I had open with have on items FDA what comment what proposed FDA. achieved. to

Andrew Tsai

Thanks.

then -- What out maybe is another study? seem juncture, would the if as you. But that would where study. this you the Thank consider -- after nothing if when a would changes real have if then not And study Type the be my that doing guess to question stance, so, the at you you it play there's new another point consider first? does dynamics would I then FDA consider not,

Remy Luthringer

that have the – and the able we studies and hopefully have how in is this to the to hopefully two will we'll well of our of we to answer your FDA say, to, review help controlled to meeting I content of adequate the be to the NDA. and enough question think the the mean start I clarify have Again, is is the meeting. need NDA

you let meeting So will again, I the the we give us after mean, clarity meeting. have more and

Andrew Tsai

you. Thank you. Got

Remy Luthringer

You’re welcome.

Operator

Thank the One moment for BTIG. next from line next from Shrader question you. our comes And Tom our of question.

Your question please.

Unidentified Participant

for This Tom. Thanks question. is [indiscernible] taking morning. Good on my for Hey.

makes any similar Yes. roluperidone of like more it partnership trial the a approved so So different what if might guys may before as how on sense kind And be? required look were like, does other now? follow-up, Thank you. then be additional or thoughts data could you

Remy Luthringer

can the for I will that But the discuss will hand think the we views. next provide. we question, this, his what topics on part the the based for concerning letter, obviously we first And mean, yes, and you the Geoff, in again, we raised is give additional FDA will I have I the to received trial, mean, see file. refusal the to data to I of will over

keep and complete again, So and please? a us good clarity. the first the can with will take have Geoff, have meeting part, hopefully, you FDA with we

Geoff Race

really much add Nothing that, Yeah. to to Tom.

think, address And Type A our clearer of the on study we it’s what whether whether much strategy kind like, I looks we'll do of can to of that best in path the forward that another it's from clearer best idea, study, have whether it partner. necessary it's a own with view, to a following whole idea a or point question terms do meeting. to then a do

that we'll Type meeting. following those take are to A decisions the think I need

Unidentified Participant

Thank color. the Great. for you

Operator

from Instructions] question H.C. And our Tsao Douglas [Operator the comes line next you. Thank Wainwright. from of

Your question please.

Douglas Tsao

taking the Thanks Good Hi. for questions. morning.

Just or indicating the A was have of anything from a in it of Type letter meeting? to getting a they notifying willingness just refuse specific the and sort merely a to cite did FDA, decision file

Remy Luthringer

Great question, Doug.

give reason to topics and mean, I yes, discuss. So always will normally, a they the we these why, to are have go

a So definitely, gave why. few they reasons

this So definitely. in we the discuss will what Type is

Douglas Tsao

Okay.

can largely -- the interactions so raised that us focused on issues with same it in would give they the some And the previous agency? you they was had -- again,

Remy Luthringer

next step mean, go the open think, have then I as it's A and because into details an here. not really is to I obviously this wise before, meeting. Type I So dialogue we said I the think

comment So not on really this. like I to would

said will so are I'm really making hoping I As clarify meeting, able still before, we I we mean, progress to each a that we few in time the be speak, A open. items Type

Douglas Tsao

Okay, you. Thank great.

Remy Luthringer

Doug. Welcome,

Operator

Blair. question the And for our from our line comes question. One William of from Minter moment next Myles next

Your question please.

Myles Minter

Hi.

it my a is Just this understanding FDA truly for is there, A as question. letter like that forward the is to this sort put the they Because a commentary Type propose first a or in That's potential path Did that clarification a did non-RTF saying thing of recommendation? question. all meeting have is just in a RTFs?

Remy Luthringer

as Yeah. A meeting. No, they proposed a Type

Myles Minter

that believe to of a something when list A in going to your you Thank is that Can have us in came of I you'd then you. because from control, you of what meeting, were you they requested you questions how And interpreting give at least that's Type FDA like a meeting. is that and list not the Okay. flavor respond submit addressed those the them? to questions

Remy Luthringer

No.

So limited and have obviously was is extremely is the the FDA. the focused list of letter, we as what question on from completely in

it's not or they Type This on raised focusing letter. So the A is it's meeting. whatever that principle a new else of few questions really in points the the

Myles Minter

Okay. for the questions. Thanks

Remy Luthringer

Welcome.

Operator

a follow-up line question. for from moment Andrew the from One Jefferies. Tsai you. Thank our next our of question next And is

Your question please.

Andrew Tsai

Thanks.

other in the you appreciate we year? you. look can I pipeline? Thank I questions. kind forward the Just of to that Are assets just to steps your “contingencies” next one you gauge thoughts working perhaps or on on follow-up. wanted planning? next contingency more there Are taking

Remy Luthringer

Yes.

So well. as great question

So But the clearly, asset an asset is most true like driver. not stage we obviously, and value and would focus important late it this that the is moving. the on it's we early pipeline fast very we moving complete it roluperidone a are – pipeline But stage because really because as have are is moving. a pipeline we obviously, have is to this this as

of course have think the roluperidone, So will this move we well, mean, year things definitely. report the very stage mean, during rest can these next probably if what which I on will yes, the of indeed, I absolutely. we going pipeline are well go I And with early it achieved pipeline,

Andrew Tsai

on Type crossed luck. Okay. Yes, Thanks. fingers Good Well, the A. perfect.

Remy Luthringer

much. Thank so much. Thank you you so

Operator

program. hand Remy This you. conclude to Thank like the to program further session any of back remarks. for does the I'd question-and-answer Luthringer today's

Remy Luthringer

Yeah. Thank you so much.

the earnings -- gentlemen, a meeting. update this you ladies Just concludes and Type and give really an looking it’s after to our really call forward A

the have as we place normally And clarity, release, our to day as is all minutes drug forward meeting take move basically sorry. later the the and at will the get all FDA in the time we with no will mentioned, the – and drug of the as have order meeting, you we what XX press you we we and end States. soon and have know year, how I next a days an of achieved important we in of approved the in this end to think update. achieved say, So give meeting as a to you obviously as with insight looking Thank extremely requested roluperidone, give for forward -- which United before you again we

Operator

does Thank program. you, in This for gentlemen the ladies participation and today's your conference. conclude

disconnect. now You may day. Good

Minerva Neurosciences (NERV) 9 Nov 222022 Q3 Earnings call transcript