NERV - Earnings call transcript Q2 2021 | Minerva Neurosciences, Inc.

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Operator

Welcome to the Minerva Neurosciences Second Quarter 2021 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 at Investor like Boni, to Minerva. now President Vice Relations would turn over the William I and Communications Please proceed.

William Boni

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

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

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

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

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

Remy Luthringer

morning, good And joining us Bill. you, Thank today. everyone. Thanks for

in in of portion Application C roluperidone enrollment Following in Minerva a continues first with the Drug Phase and submission trial healthy meeting completion of to volunteers. of end, the bioequivalence have XXXX. Type a the pivotal in with X New with roluperidone this Toward the schizophrenia, the towards open-label FDA, study of work half we the the completed

activities make request NDA for of also clinical over submit We anticipate forward to anticipation submitting the components dialogue including meeting. continuing progress in and to the pharmacology, these CMC the months, to FDA in assembling look continue for an completing required a We a we coming with and non-clinical activities. pre-NDA our roluperidone,

designed employed study as in healthy manufacturing. and trials, X Xb the with April begin initiated XX, in new volunteers. is formulation formulations bioequivalence supplier in facilitate commercial study me this compare screening as in at with conducted objective On least to Phase The large conjunction our the Let study. XXXX, to we this one subject scale well of Phase

activities third results XX the reporting which forward June XXXX. XX, completing We top the between in the X:XX] In look we quarter study, working XXXX, we demonstrate to We enrollment are of to roluperidone. November. by are in study. the the additional extension. The our from parallel seeking of by NDA similar NDA subjects line submission On findings for rationale completed an [indiscernible this are several summary, for FDA interactions supportive In drug are bioequivalence last with informed submission expected with Type support formulations. findings was required activities since to the strengthened meeting were in on the C key the areas. These the open-label these U.S.

open-label and First, negative by as Marder measured throughout they received in duration the Factor roluperidone patients nine demonstrated improvement with a Score. monotherapy the Symptoms who continuous Negative months symptoms among extension of specific the period

and improvement Second, with Scale. Social functional this was correlated measured Personal Performance the by as improvement,

rate approximately XX% rate relapse in seen relapse literature. schizophrenia than Third, XX% compares with more favorably of of observed the to XX%

extension the symptoms, will with package. prolactin tolerated summary, increase of believe gain, no represent well important the that study extrapyramidal showed that In sedation. Finally, the weight data component bioequivalence or completion roluperidone of we NDA was the an

the encouraged raised issues interactions by November. agency, last meeting Type ongoing nearly We addressed our have we our are at with believe the and of C all we

We completion also are of NDA. progress excellent the the making towards

a Following to to to we a readiness over Geoff the financial for the content the I meeting with NDA turn discuss study, for FDA request update. it bioequivalence and submission. successful plan pre-NDA will now

Geoff Race

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

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

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

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

X expense in months XX, and June the $X.X compensation R&D was ended stock included million $X.X and expenses For noncash XXXX XXXX, respectively. million,

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

included ended XXXX in were costs for lower was For ended in clinical core X XX, million, trial the XXXX respectively. of and X-month June for the May XX, XXXX trial X XXXX. for X- to the was expenses the versus roluperidone, million primarily the decrease noncash of R&D and same period periods compensation both $X.X Phase June stock months in expense The $X.X and the XXXX X-month which due portion completed in study R&D

and $X.X For $X.X the of million respectively, million, and expenses general X million. approximately were months XXXX, $X.X a June and administrative XX, XXXX ended decrease

compensation in million months $X.X the was For ended and million, X $X.X noncash respectively. June expense XX, XXXX, included and G&A stock XXXX

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

as primarily for the due the $X.X a per of to months diluted per compensation. basic the certain included noncash due in million, $X.XX and X stock June in expense expense benefits. and income both was June in and XXXX, was and for of decrease basic XX, stock-based or stock X- periods in compensation $XX.X net of G&A For higher million million to were X-month first charges approval G&A Stock-based ended respectively. $X.X net opting basic per XXXX quarter was due Net of the both $X.XX program million of X net the loss option and the The primarily $XX.X compensation company's with XXXX of were the quarter to of of certain net of basic XXXX. Net income ended decrease or XX, noncash XXXX. XX, income severance-related second share compared ended $XX.X income XXXX, and or loss X-month grants the million diluted second net net Janssen to X XXXX, share XXXX XXXX, primarily the of second in to for quarter million decreases development for months out of XXXX. agreement X joint net for loss income seltorexant share diluted first periods the June Pharmaceutica and per The for diluted its loss the and and during compared $X.XX of $XX.X was as share $X.XX or months of for $X.XX $X.XX

previously a As the revenue, Pharma with the recognized connection loss of the the XXXX, included year, both X- noncash the for balance The on of interest XX, June million, on ended company to of the revenue. incurred future X-month agreement, versus included $XX.X result January company's XXXX. been included in Net $X.X in opting sheet. to the immediately sheet is expense period is deferred million respectively, had under which during expense and and noncash out collaborative of million in liability this $X.X royalties Royalty balance periods sale interest during related zero of which

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

Operator

Instructions]. [Operator

Our with first question comes from Tsai Andrew Jefferies.

Andrew Tsai

addressed the I've come of up over and meeting. up had things the the -- FDA C of with the time-to-time on is First impression, course from came extension. you've the open-label question just I XXXX, you've during that with Type mean interacted some that the

that the you discussed Or later happen to FDA have progressed? on data the that's pre-NDA guess, expect Have if I extension true, QX how So meeting? those we discussions with open-label yet? in should the

Remy Luthringer

Yes. Remy speaking. Yes.

the which the no, Type data beginning base the of been on topics interaction with a FDA. have year since definitely, raised open-label The not So have about during meeting. are the regular the we have C extension discussed the we

have mind an package for submitted published, piece to open-label keep we our briefing put the extension we been part definitely FDA to the important So if And of for pre-NDA moment, information, this as of the obtained. obviously you will be you results the book meeting. our I it's guess have in data, And presented. the or seen,

Andrew Tsai

the evaluating I I different to like design for how many what And data know XX a patients see formulations. in a want little we study, follow-up exactly give do of basically? top you're It the study? around doses, the Great. clarity us line guess sounds different more can you bioequivalence bit enrolled. as X the just

Remy Luthringer

a great question. It’s

the last the mean with I as we before shared from did feedback not of could FDA. been I the from the has first feedback start So all, I start got we mean, the protocol study the the the we FDA. call, the basically, study. said and FDA, having during earnings Obviously, And

mean, I So C between during X. meeting basically, formulation the of you the Phase if was terms FDA and in Type Phase the Xb about differences questioning remember of

Xb the Phase to main exposure which or that to the been here equivalent demonstrate formulation objective X the So has used. Phase is same formulation, exposure the has

the of formulation we really the of Xb improve Phase gastro-resistant refresh mind change. is Phase to major was by did food a we distance thing to food. And mostly in a effect the Phase no effect, why the order to what there had only Xb the the The Just we formulation, the reason and putting tablets everybody, food tablets, the effect because between a in X did them minimize give had formulation. positive the you to food from that's

to the were definitely gastro-resistant. tablet successful we So this effect, food putting minimize and by

is we But objective mean, to of the this of main I is So what terms in compound. show again, did. exposure bioequivalence the

obviously, at Now third, the with and our scale this working to already with also is a we we after, because tablet, be ready -- a provider say, of FDA. which tablet, because the level, up to included positive lot outcome have a are having how commercial

some be changed. I Here, ingredients to had mean

terms has industrializes to, only changed nothing our tablet. of So active is It say, ingredients. in to how

study, power subjects. to Because pivotal you healthy X XX subjects? again, a XX it need it's so considered Why So accordingly. formulations, as

subjects basically So powered this own number the and the reason subjects you why need XX%, in are controls. of their to be

X compared. And can be so the conditions

food we arms Phase reconfirm which with with tablet without in that, order do are to we We also formulation. the have had fact a food Phase we added, obviously, positive Xb, not I have and mean, controlling which effect, X for in food

And study. answer large about quite be effect. to bioequivalence also pivotal the as a the that’s about So final and considered between answer the food the tablets powered study a

Operator

next comes Blair. William Myles Our question from with Minter

Myles Minter

here, and me trial. that analysis I hierarchy I on population disclosed aware wanted understand it X the has But in multiplicity I'm degree the to was mITT to you could Phase actually you that statistical I'm tell the trying P-values go understand sat? the to at to potential be nominal. to endpoint nominal primary apply I point just of that. the to Statistical what prespecified in wondering analysis whether of the back mITT Plan. know I'm Analysis of the

So I on great. just that color would sat provide SAP? want could If to that, know in that be original it any where you

Remy Luthringer

Yes.

answer question, Mike, happy a to and very, it to so So very clarify. -- I'm be obviously, to able important

was it when these opening during XX we review, I blind study, site with already, blind the same picked up basically, as So explained before level of patients. up because we at the the the picked the

matter a the But we moment can primary submitted obviously, have as it's review. you will data, So C Type we because was X-X we nominal minutes and final not that obviously, we the from Analysis But endpoint. put And we document, at the about the FDA patients. P-value it proposed level. -- data. meeting always for And we data speak the the a ITT. Plan, only when or mITT the the analyze the here put in mean, to the and ITT of of I seen This same is Statistical them

telling FDA the always a of fact our because you accepted the you should to and and I we with be file They with into mITT. As have that, mITT matter they it submit will go confident, is ITT deeply the know, data. is review mean,

went. events how or the with is the this interactions So the FDA

clearly next. of should So from good what really through but good some as why of clearly But very And subjects, we you I'm is it's is quite the think as mean, It's mITT. I very I discussed, go mITT lot see you if mean, precedents as agency. will I the review, a you with again, by a we I where very matter there, because the exclude can go confident identified. reason a you mean, before, already rationale, have a recognized

in are here is And where so topic in to be considered. we definitely so mITT the space, even of CNS, the something

Myles Minter

bioequivalence try to around additional or with have conversations with volunteers formulations, run -- run are X will commercial obviously, outside from Like clinical Okay. by aligned you on the something, with Phase an the fact and them to make not submitting it. and Xb Fair that, protocol about I'm healthy that comfort Phase they had safety with their curious of the and are study, then formulation you past is like chance the commercial this to have maybe for enough. the agency and And the whether that they data run level as being Catalent likely you've the prior the the you formulation. NDA. have that you but here no happy that for won't data study clinical There's yes?

Remy Luthringer

the just not are I described protocol. mean, clearly think I because, commercial Yes, we clearly and between the X our differences Phase the in what formulation

obviously, to of have, need at the CMC package -- to or what in you data solution all the CMC the for of your the feed terms We NDA. end

will minor. been the have it not level. ingredients, think mean, protocol. the at say, active the clear in -- be this I we and the are -- there part of pretty does the active tablets. I So and change clearly, how But really no to modifications mean, purely Because technical, overall of surprise the I It's

do I problems any there. foresee So not

Operator

Instructions]. [Operator

Butler Our next question with from comes JMP Jason Securities.

Jason Butler

continue now plans presentation are obviously, over wondering, awareness a at non-branded MSLs any medical awareness program What have next the regulatory you access and to an in U.S. Europe? the through OLE on secondly, the build have meetings, for Just or -- do then your you to but you or year either bring data data Obviously, the submissions? even Or or any plans here the board data. progress or and expanded as that, beyond so of of campaign? drug plans to

Remy Luthringer

Jason. question, Great

present College be the also I And College end American European Neuropsychopharmacology. some are will of the medical presentation at at yes, think we ECNP, there we meetings. of at obviously, will year. Neuropsychopharmacology of present And So the

mean and us, to becoming we in have mean, scientific part advising order yes, this of we aware much involved data. weeks medical also the large in So I data, as disseminate community. with when we I of definitely, the quite few we some And a very will data larger speak, we have this got our discussed KOLs but last to over extensively went the

your, I important. webcast, decided not about I and Because For our say, broader give have our might again will mean, think really development we how but we a complete update I a it package. approach, which think about yet, is

the put So this And into also updates, is I study. we give bioequivalence context. the about mean definitely, will obviously,

containing in the We to like will give Sigma pharmacology. very about think the hot updates our drug other pharmacology is target targets. of I addition the topics Because the

to So will preparing trial done. I focus starts, on and topics submitted, all a and here, focused new this the stay life between different NDA but the we this, we Afterwards, the it. But mentioned. you get R&D will on will think and today really do best have we

Operator

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

Douglas Tsao

you work with obviously, So or earlier now that submission. roluperidone prioritizing see lot of thinking all about? the financing. with in But I'm the for a some we are have of just indications other of just some I you might trials the the proceeding you're about given the obviously, going but opportunities, and that activity when given thinking just on, that you I'm curious clinical about have how that mean, Royalty starts? curious how other breadth more we've Pharma NDA settings talked freedom you're

Remy Luthringer

this -- Obviously, in I parallel. mean, is we

We are -- brainstorm. really to continue

of out First maximum of continue we the our all, to data. get

example. an you give I'll So

-- to the the We are linked functional PSP negative on from in score. much improvements how with total -- improvement in currently working symptoms is

are -- we also a PSP. you subscores cognition. We have if signal of terms remember, in of focusing on We the

Hopefully, working on on the definitely studies, of carry on our of also approval inside what we the ecosystem of internally would with And schizophrenia could also worked we terms -- and out this. with based definitely terms which transdiagnostic. next. be in are cost KOLs, We studies, and

So of clinical the that in are understanding is answer I right also a is the running having to what right the good if your of anticipating CRO guess question you use we’re side, a understanding study. to

this because But setup here. this order FDA. plan in I'm half with also pre-NDA the discuss I we to to terms know, -- second I is in our in together that one right So trials I mean clinical activity quite you we And a as this expanding important have will the mean, is and point indications. the are the mean, is year, have, when this we of of sure meeting putting

have the also the and options order different that have efficient which in making clinical run conditions in with organization. So we're all a the we of place effective discuss, in plan think with very the in can sure the sites, I open needed, we best surely, if FDA. to And we slowly but best trials trials, with terms best

FDA the ready. let are we mean, are for very moment, we So before are the discussion clinical with a any have us on I good working But But we trial. good very meeting, first, final a starting it.

Operator

further no Remy closing to the [showing] at back over turn remarks. this to I'm Luthringer questions call time. like And I'd for

Remy Luthringer

so it the bioequivalence you time Minerva all thank results great who FDA and everybody -- points for very questions during the will open-label participated study call. for for of Type and meeting. a you C one the by much, it's Obviously, really raised be this important Thank the Yes. because and was important this very this in

also update putting the and working and today, we of NDA and forward the all not we preclinical are we because into package. very also this this our soon working package looking we to this making rest on on progress but -- all are did really discuss I'm So you are

forward you am So Thank is update and you participating. going on, I all for soon. a lot looking very to

Operator

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

a great day. may Have disconnect. You now

Minerva Neurosciences (NERV) 2 Aug 212021 Q2 Earnings call transcript