Earnings call transcript Q4 2022

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Operator

Good day, and thank you for standing by. Welcome to Minerva Neurosciences Full Year 2022 Financial Results and Business Update Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Geoff Race, President of Minerva Neurosciences. Please begin.

Geoff Race

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

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

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

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

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

call over to the to like now Remy turn I'd Luthringer.

Remy Luthringer

and and for for Thank for Thank us Geoff, our plans morning, good everyone. you joining XXXX XXXX. today you, of review a

interactions the schizophrenia. FDA of in attended roluperidone, press regarding year, April the on March of path C with its a outlined diagnosed XXXX, for advised we for we had multiple Type lead our During we which the in forward in with compound, patients the In treatment negative XXXX. our the concerns, symptoms release regulatory remaining FDA which meeting

Specifically, and U.S. primary the was end conducted X the met the concerned the not FDA to has of data point. with the the population, Xb applicability Europe Phase Phase in study

FDA patients used could need stability reassurance to the Minerva the of that roluperidone by identify how sought may patients. addition, be reliably noted those FDA has that In not that in or The antipsychotics who that antipsychotic those also efficacy evaluate and do sponsor show significantly intended does prescribers from use the monotherapy presented that not to of noted medications. with interfere roluperidone data a the way differs not the safety and

for treatment the Following XXXX, of for by symptoms the supported Phase stable data, negative addressed and an Xb In provided and schizophrenia, which patients studies, August placebo-controlled the In Both of captured multinational, period. the studies three studies taking studies schizophrenia. raised placebo-controlled negative Phase before patients placebo severe doses late-stage, discontinued, by group MIN-XXXCXX believe The to submission to XX-week comparative in in Minerva XX-milligram the antipsychotic through concerns symptoms very symptoms results data was were submitted NDA of for Both additional that C the period are moderate multicenter, with positive were pilot in studies and the similar with being randomized MIN-XXXCXX patients short well-controlled implemented X. treatments we washout we Type was arms. one meeting, as double-blind, FDA. roluperidone. study had double-blind both randomized, which of or a patients received studies if overall XX-milligram Both roluperidone design.

the of long-term tolerability symptoms demonstrate data open-label negative stability continuation roluperidone, MIN-XXXCXX of the also provided positive the the exposure studies of relapses and regarding intended study XX study roluperidone maintenance safety improvement rate on weeks and Both MIN-XXXCXX of specifically in to and periods. of of XX-week blinded of symptoms symptoms, following efficacy doses positive low based and

and mentioned of duration negative positive scale and nearly of these CGI. As with to and were label patient global the PSP, above, studies performance exception social two syndrome personal period, with impression, pans, population the open assessment respect the scale, clinical identical tools,

the basis an were area for the the review an submit these psychiatric FDA. we medical the in support of such, and, long-term data of safety believe the sufficient evidence efficacy in to the unmet as merit high to in-depth consequently, decision As need NDA adults the division by from studies and provided they

dialogue Refuse received RTF, continued File psychotic our In FDA a to letter, XX. as at on November A October Type the a XXXX, we meeting division, from proposed by the and

meeting, information discussion coming RTF status developing that Following months regarding as the remained FDA with of the the to negative roluperidone program. transformative the for it patients effect. as look potential We to becomes and the forward further those anticipate committed provide I confirmed development remain symptoms FDA the available. NDA in treatment over with more schizophrenia. of the a we that roluperidone And

to over turn performance. discuss now will Fred financial it to our I

Fred Ahlholm

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

Food for allows made business accordance $X.X and waiver human This from fee of cash restricted Cosmetic application. of and Act, its NDA Federal first XXXX, refund our small FDA. the as which XXXX. XX, equivalents Drug we million received a $XX.X million fee cash of December $XX.X approximately refund to In as million were was compared January XXXX, filing XX, with a a the submitting of in December Cash, drug

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

research and for fourth $XX.X in to XXXX Research and decrease was quarter respectively, million impairment development decrease development million of value our of the in to $XX.X charge in-process carrying a XXXX MIN-XXX the and The expense million. quarter primarily of development million, an related to program. of of XXXX $X.X $XX.X due expense the and fourth R&D was

in as primarily $XX.X value due and an was a clinical The during for expense R&D quarter to expense the of million Our $XX.X $XX December of decrease R&D respectively, was years XX, in XXXX $XX.X fourth million. and decrease research million, related MIN-XXX to XXXX, ended million and XXXX impairment the XXXX. of as costs charge well the to in-process trial lower carrying development of

XXXX costs R&D $X respectively. December years the XXXX, XX, and included within and compensation for million $X.X million, ended expense stock Noncash was

was and due a and December lower General XXXX, $X.X fourth quarter versus in of of decrease the and primarily million, to and expense million, G&A $XX.X year administrative expense G&A XX, insurance decrease for compensation lower $X.X period both for was was for a December and and the ended decrease respectively, million. prior legal year and expense the expense million. the $X.X The million and respectively, fees. fourth XXXX XX, XXXX $XX.X million ended quarter XXXX, $X.X XXXX of years

the expense included XX, $X.X December stock $X.X was million, in Noncash and G&A million costs ended XXXX, compensation for years and XXXX respectively.

or a quarter to basic of or loss and net the and compared million the loss $X.X a a of fourth $XX.X diluted. was share of For share loss diluted, XXXX, fourth for $X.XX, as of $X.XX, per net XXXX million loss quarter per basic of

$X.XX, year versus ended a million $X.XX, share million $XX.X for net was and year December basic and loss share diluted. diluted per XXXX the a December loss loss or loss net of For per basic the ended XX, XXXX, a XX, of or $XX.X of

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

Operator

first Instructions] Tsai with comes line [Operator Andrew from Our Jefferies. question the of

Andrew Tsai

all updates. for Thanks the

the propose you that are curious, us. time, NDA? in RTF recent stance question it issues to items FDA the last with I first their said the and A greatest your meeting the possibly is, issue remind kind did outstanding you mine FDA us a share the I'm think and Type things FDA maintain what has you'd afterwards? few the latest just then of the the following So caused and those with can But

Remy Luthringer

great question. Really Yes.

So clearly, Type outlined the I we already yes, meeting C the as FDA we mean, with concerns the last mentioned, what year. after had in April we were

or study. progress, study, think I struggling they a they they're mentioned So study the that made -- main of with CXX the Otherwise, suggested results. confirmed I is two Xb I we've as Phase we mean points, this think lot study still of fact that and the positive are as the but well, have applicability clearly, really the a but

I that we patients. the is this has are U.S. mean But struggling fact no study

be to to know, you and about free in symptoms, because, there negative so no U.S. want symptoms of they mean, sure symptoms similar, this. in negative are disease, is and approved want negative terms terms sure as in So mostly of drug of I for they non-U.S. be that terms patients extremely

the So point. this first is

they is is Phase fact P-value this of And to highest the used having the a we in X.XX. about as dose the X.XX. concerns correction, has And that X correction. a only we case, have hitting correction, X you some this point, Hochberg And hit the need are know, P-value still which to And our is for Type the due it Hochberg second of have study. tool a which the

And it two or working the is I my So if opinion, is not drug telling this really concerns. it's, at not. main you all in technical. But is the mean

allow you comment let the on two if me So me, concerns. and

and had the from patients the are by symptoms the of provided Keep baseline, other case ex the U.S. similar compared continue included even mind patients one, have other Phase we've that the on stronger. sponsors U.S. from showing mean, performed U.S. them or terms have in that studies, for been the dialogue effect which have overall order the U.S. the We to of providing we disease. negative the make our of of So FDA, drug to the terms in in our even of extremely the to data information in outside the basically, are in we I patients first the we with data with included X, have we in and

really I'm we confident this something which So overcome. will is that

Now X.XX But an mean dose keep as mean, not we concerning that, yes, for Phase are is I mind as NDA of asking for our disclosed, XX asking already indeed, milligrams. an only I only approval the we in hit XX-milligram XX-milligram the approval X study, P-value. the for

to if similar is seen it we So XX-milligram, you're I the with X Phase Phase Xb have what think study. have very, the looking really what in we clearly, very seen to in

only have which P-value, if we key mean, I that, was which secondary had remember, And patients. highly is important a endpoint, to one is PSP, significant the was extremely at everyday is X.XXX. which looking there, something a And you of functioning which we

looking are significant you the in when the are to do Phase Phase clearly, way P-value improve, these a and So good with a X. in clearly, patients Xb in improving they

clearly, if is don't So -- the I answered question? issues. I I are mean, what your know this

Andrew Tsai

clear. it's Yes, Thanks. very

Is it going And so about and months outcome coming resolution meeting? that know timing or clarity you're outcome timing any even A of And like forth. sounds the it, the talk also don't to another here? you thoughts of how so be over an now on NDA the any to potential the them Type I classify of to it the this? around but going Or

Remy Luthringer

next So be months But we will I me have or it weeks, timing. hope, mean the is this, I basically. let this obviously, put happen the shortest few about and dialogue we the ongoing, coming we to line. mean as cannot the mentioned, time I like few in think clear

I I an and allow what a lot is information bring that fair we think it's comment, to But in message, are as a additional trying think of a completely over really you our NDA. have if me we message,

details, total if X you patients, mean the scores, PSP. which of and For key was information and I we lot functioning example, we have the what score I non-U.S. patients that of I the functional the comparability analyzed have a in confirms in remember, is have the again improving, improvement U.S. in mean the PSP, of X between Phase drug about patients. you the scores before X sub so we But had because sub primary was about mentioning just

review, to high, to for message sponsor symptoms we I So bring data I in-depth what which, the really negative the before of trying of our dialogue with to gave a analysis an show drug are topics, a roluperidone are the a a we first that reasons, in-depth you as to an diagnostic go and that effective patients but reason all, our suffering an really no NDA, having over of to all FDA is need into of mean, from the details schizophrenia. reset have

dialogue of is this timing more in they ongoing networks, So cannot details. you the and terms give

Andrew Tsai

sense. just sense. this NDA? who Makes Billy extent And if curious the you That your was And I'm very question, change departure makes overseeing Dunn. last so, FDA has to at can as anything on to application? the NDA pertains it does the been if the calculus it share,

Remy Luthringer

That was a great question as well.

the has I the yes, clearly, as the the mean, NDA mostly the are A meetings for your with Type to clearly, and mean, from because, mean, you division, know, mean, psychotic decision dialogue division. C So is been I submitting or main basically, you're when I I with Refuse division. those coming Type File psychotic That's

This Dunn the a and was one, involved, obviously, like psychotic side, was three divisions of person other two, also divisions division Dr. he because already overlooking neuroscience indeed, the years.

So also to indications that is we a is indeed, to Dr. see but to approved with really or no what important P-value, very mean is to Dunn what with person of which is have I is say to Dr. only improvement, a a open I keen known Dunn be have very who that yes, can I And developments treatment. is roluperidone. is function not think

it's a clear it mean that on problem he that, the I improvement Dunn that function But the I will think of Dr. understood clearly, left. I So is important. us for don't be mean,

that is say, of open also confident been people place is to And has the and person understand. I'm at FDA very, will Dr. knowledgeable other a So think innovation. person the in still the how who who to I the Dunn nominated

along seems lines but we Dr. problem, people to a the has the not in that's work proposed set in continue Dunn place, So to to past.

Andrew Tsai

for luck. much, good. Remy, all the of Very updates. Best so Thanks

Operator

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

Douglas Tsao

as you your Obviously, roluperidone for potentially just agency, you path uncertainty. when interactions think follow-up. a one study forward So still that would there's But some the envision with the do and concerns? monotherapy therapy one run would as could be adjunct a to you as to sufficient their be address out Or need trial? in both well that potentially study? carried Or potentially an

Remy Luthringer

a great always, Yes. Like question.

us, we us them you, already that so I additional clear, additional to the is And that, an mean mean, I as never continue I doing. study. very us I mean, this be with they we are think I with FDA to is run asked mean exactly as So they to speak, discussed asked wanted feed to information. what

about add-on your one. and is comment an monotherapy And interesting

clearly, in for developed So several roluperidone reasons. we monotherapy

in first to unblind this cannot the drug-specific effects is you effect. have is As order because if it immediately is. it placebo because you second, mean, going you mean, for improvement symptoms here put, will on I mean negative do do example, the exactly antipsychotic we claim know, that, mean way of you I you because reason the I versus study to specific monotherapy side to only And don't know a I have antipsychotics. board the is you what on of the demonstrate

this reasons. one was So the of

patients antipsychotics. even not not of diagnostic be of now continuous treatment with I really schizophrenia medical mean, coming schizophrenia second I reason community part there end patients treated that the who mean, all more should is I a diagnostic important, are very scientific that and day more saying with do continuously significant at showing need for with The the more now is and out the is is the that, there with think, data the community patients of antipsychotic. And the of importantly, the the

exactly we needed have negative So population PANSS. the patient this symptoms is of targeted. targeted score have patients, Remember, whereas I minimum we to a the on

when And the show an to had our as data, stay months to level, positive needed positive over yes. last to stable low looking negative to that, there, I extremely Just this I on and six symptoms. the PSP. improvement be mean mean, have we of extremely patients is this and impairment what symptoms they stable But of have you stable symptoms in see these yes, you're

points the study, study. stable no have out are points symptoms, And XX they is are positive you I mean XX when if completely there no points. X in know, symptoms. you of of the when I so terms at go end score patients and of they have the are the if you as symptoms, positive minimum these mean

as also have presented below see randomized withdrawal studies remember year, very in rates. is of one placebo what with I rate I low, mean, around relapse a the there And which the And over relapse well, XX% period is antipsychotics. you the we

think population, with need antipsychotics. clearly, minimum, demonstrated have we we continuous patient mean, have So at I not the that, does treatment included I

cannot but into the also we responding patient FDA provided never well it, needs I So that because the to go he's details disclose we really have antipsychotics. if antipsychotics, extremely evidence a to

study, your story since about a we worked antipsychotics, where plus short, with have monotherapy or combination questions of an it study I thought additional a our to combining monotherapy study think development asking the review mean, long answer But FDA these to by the about are are have the roluperidone. in-depth a you're this. obviously, you really doing on NDA. So of question or We we complete beginning yourself you're after, I of the

what post have And the approval. do this to usually is companies

mean a labeling, to data mean, but open antipsychotic are the least, is mean approval the proposing obviously, last we're monotherapy labeling that, as FDA not shown just has antipsychotic, we here, we are doing and we trials. post needs we if specific this is proposing So for completely an I I have looking when data relapse here, job, a patient for clearly, what and and what as we And we trials. the And know, the we population yes, basically. the I our have in to patient targeted again, you're

here, long is a this story again, but So a logic.

to because of all well NDA So post-approval work and in I characterize two is an normally is controlled needed better these on is order review. of and adequate things, kind think, and the have basis what we studies, this all well

Douglas Tsao

data I'm but be mean, and there sort you, while, needs may hear come I because path there I a where the forward point just so standpoint, does point, just you expressed just of the reservations. pragmatism rule guess Remy, another I I asked agency to to be a out financially efficiency carrying your set, So might way yes, -- wondering, from with has some efficient the And maybe go extent, this point. an most existing if even clearly, study just to at

agency I Phase result and that the out read would you back X, be able if that first to had back step the about go we then have to we follow-up And run by pivoted to mean, from when think go a data with study, agency probably or set, for nothing to now. an the would to incontrovertible question. study them had you really if

don't do guess point I I so feel you at mean, what guess, I those know So -- if that's I you've options? exhausted

Remy Luthringer

clearly, go run? and study you kind mean, you're but done. you I of the not by And I us you are on just hear run another So telling one monotherapy do very study, mean okay, well. started And saying, I only which

we don't enough. we not I wrong. about basically, the this clarity, Yes. I'm carry study. right companies a they out. there that study, about studies came about try where blessing that have the reason here, -- And had one or I study, complete precedents the think are with positive study, the they a mean, the that agree We complete additional is because really the some that's to again, complete we I have when FDA to run question of thing. is back doing did understand the from FDA study mean get an this. if they need the the need That's we are clarity thinking mean, to completely and the something why package So convinced

is we the So NDA. FDA really complete redoing is have and driving a I us. what for again, think looking But it to I package jump we our think are the clarity, get and

Douglas Tsao

them to very just what so to part understand to of that of it But Remy, as final studies is with the because just current point, may think get sure, on clarify needed? potential that discussion your important, agency, is I everybody make additional interactions be clarity can so part from

Remy Luthringer

no. is answer clarified... Yes. What have The we

Douglas Tsao

still are simply pursuing the you trying So approved? existing data set get -- to

Remy Luthringer

Exactly.

an So I additional mean we about are discussing not study.

not We additional do long since we the post-approval what need they is guidance also of File. go are are of understand we I analysis of you I a And part in to according what if we door this what to at our a mean File, trying the have the Refuse studies. reason set the to call discussing that But as data have is opened mentioned to Refuse beginning to currently. are

trying understand FDA are part say, what review. the So is what package in we to needs to how data to, order our with

think the more mean, more needed. And data we that I I advancing clear indeed, becomes have

little bit on what a this, and we update constructive currently. outcome So will you of think, the discussions I is on going give an give us time,

Operator

hand remarks. [Operator Instructions] I'd showing for this conference questions to at no to like Dr. Luthringer the further over closing back I'm time.

Remy Luthringer

still really if an we to I need Doug treatment medical a these review on really soon approved think unmet hope huge have the everybody it in-depth very, are for much. with have no important And understand And address FDA, thank that dialogue questions. that that will will happen. explain, Andrew, by very which U.S. I data to needs important this the package, very really next are and really steps. Yes, as roluperidone a mean very But you, clarified I a get and you important will drug this important I confident really starts, we to I review think in is thank an what about clarity tried we so we the going that

much dialogue you we FDA. your update with So today. us the -- about forward the on I'm looking really as clarity for going being as so with you Thank soon more really for currently have to

Operator

concludes This conference you. Thank Thank your call. you today's for participation.

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

Minerva Neurosciences (NERV) 8 Mar 232022 Q4 Earnings call transcript