NERV - Earnings call transcript Q4 2017 | Minerva Neurosciences, Inc.

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Operator

Welcome to the Minerva Neurosciences Year End 2017 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. our today and end be company’s found available with Investors press can X:XX financial section the of at Time results became Good year Eastern a.m. on A website. release XXXX the

on with morning and this Our on XX-Q Form SEC www.sec.gov. annual at was be the the found report website also filed electronically SEC’s can

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

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

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

Remy Luthringer

with product XXXX, profiles and I been its to defined innovative roluperidone. we and am trials today these forward our identifier generic compounds has MIN-XXX. in now you of inform pleased further I MIN-XXX. assigned beginning use instead for this will that patients. in In symptoms XX-week of initiated going December X name, milligrams clinical roluperidone designed XX and parallel-group, milligrams schizophrenia. the of the in as Thank negative diagnosed evaluate during for the in multi-center patients safety XX trials future. clinical have leading with the marked two everyone. and to by been morning with preparatory success maximize These interactions joining designs product began XXXX. have probability clinical we believe candidate you, trial near four work of place year good execution extensive that will product completed Thanks XXXX. begin us protocols today. advancements underway XXXX will are with candidates We trial We that fifth Bill and and in and the a anticipated certain a placebo-controlled, and double-blind, randomized, roluperidone pivotal to help possible Phase made efficacy trial MIN-XXX readouts is data by the of planning be in regulatory we were with XXXX to monotherapy put This for other study

compared the over over and either by will score the respect to blind roluperidone determined baseline PSP period the change be by XX scale as from effect effect the secondary on same positive will measured patients original the score will label their a which of NSFS treatment to the primary milligrams and XX-week XX of change compared extension in receiving placebo drug. during placebo point, The roluperidone the period. will drug receive study Marder’s symptoms dose of XX-week on using to active with XX-week Performance or in milligrams and followed negative period. be The syndrome open So and patients end double total Social the continue negative from placebo symptoms endpoint factor baseline key negative is as Personal

patients for adjunct will work believe of defining Russell Rick and of of no while mean clinical commercial that Minerva. treatment as Additional roluperidone important and the size lack secondary evaluating address is U.S. patients approximately and with the endpoints a the negative expect in will for symptoms in the disorder Severity disorder first symptoms negative second opportunity in product we the results clinical XX% line enrolled Later specifically Clinical briefly XXXX. which Approximately MDD. top We to of with could our speak Janssen important depressive readout Global Seltorexant, half and to the and and an at insomnia in trial development is under of approved. With Pharmaceutica Impression treatment the these score about from tolerability. schizophrenia has XX for a XXX roluperidone. symptoms. tool trial making be U.S., the initiation positive sites be known progress market we stabilizing safety this a are towards coming Patients also of the this from milestone of CGI-S Europe. The directed stage call, been about major will

these trials clinicaltrials.gov. morning’s upon Details release initiated disorder. MDD trials During and is be that in XXXX in insomnia and indicate one with Two trials improvements in these announced are the clinical build depressive were can on press three trials and Phase findings of in These previously sleep. found seltorexant. Xb of clinical symptomatology

agreement this also agreement line August no these control includes In also Janssen XXXX development Under X amendments with disorder. top of our major advances data in this agreement the the of in the from to for with XXXX. and has until seltorexant This Janssen for effective. results compound compound Minerva expect strategic became assumed completed collaboration Xb which for trials financial We our has development indications. depressive further insomnia that on is Phase Phase obligations the development broad milestone both amended

Phase MIN-XXX patients anticipate Xb anxiety Xa show we our MDD will We upon in that MDD begin shortly. that to to and thus clinical in of results with symptoms on effects building the Moving have both who Phase recruit anxiety. also plan symptomatology trial depressive

preventing patients therapies. Patient pharmacological profile. side existing These as such strategies their of an available MDD of in phenotypes symptoms exploration to is with acceptable new acceptable that assess remission effectiveness innovative of molecules While for are exhibit with depressive biological therapies treatment treated impairment an and many particularly an learnt available, is varying sexual also limited thus cognitive level due currently shortcomings MIN-XXX an effects, dysfunction.

assess the anxiety, potentially cognition In the these further reducing addition shortcomings. endpoint and plan it the we XXXX address to primary define depression, so function product major to adjunct of can of sleep, of profile MIN-XXX an symptoms sexual as to

studies addition Preclinical from In NRG-X our suffering patients clinical toxicology are the IND-enabling other the developing protein, MIN-XXX treatment we of of Parkinson’s pre-clinical potentially for potential soluble ongoing. in believe disease to neuregulin-X We a are and beta-X disease. stage disease candidates disorders. or be MIN-XXX, Parkinson’s form beta-X other neurodegenerative and modifying portfolio, the recombinant to has

company the corporate or regulatory needs a are advanced filings summary, of expect forward trials addressed on the that addressing focused launch stage will allow of a the at for in by We we in by potential an Minerva if significant three product Each patients studies we Europe, In lives clinical be candidates. will the basis year not clinical recruitment into affected improve U.S. has serve unmet move critical execution. large with point of available as the one XXXX important currently and would us treatment. approved trial patient as to clinic. numbers evolution this therefore to

highly Our efficacy. including with entire on the these rigorous of and right is focused patients the therapeutic assessment R&D studies team on

X He stage expertise. to clinical product position the would for We XXXX. his ensure a who transition by commercial expect to President discussed is introduce joined market to as of like December. development to I effective in have in as the team candidates timely from now Rick data significant addition the I late separate brings Russell trials readouts we Rick Minerva roluperidone. to look Minerva from led our our

Rick Russell

candidates Minerva available and disease join you, call. are are potential and Thank Patients in significant. The pleasure each market disease from schizophrenia, to believe targeted well-served Minerva’s therapies. are It’s today’s to the our conference burden by in our of and of team participate differentiated the Parkinson’s indications, Remy. product for insomnia products therapies. existing a We each of MDD, not

the the symptoms believe of positive asset. severity We this their for for million novel XXX,XXX needs that comments data and U.S. market have information. most need stable have XX% stability XXX,XXX schizophrenia also advanced those two I X.X symptoms, in or X.X target of a needs. Datamonitor a represents Number to on ranked approximately will treatment. these, condition. XX% drug period. Negative medical resulted clinical on the focus administration symptoms general million studies are addressing suffer observed negative profile are symptoms debilitating treated unmet Of favorable a varying improvement innovative the for company’s Based XX% directly. clinical unmet from schizophrenia improved represent as negative brief who or and approximately is This individuals mechanisms my doctors in one number individuals Published with X-month and symptoms in by over population roluperidone, whose to-date, the negative effect these and side of recent product of today roluperidone, approaches to for total tolerability addresses according diagnosed individuals we in survey patients estimate has are believe generated

declined tend or severity episodic against Approved symptoms symptoms indicated in symptoms and that know increase Conversely, of can shown persistent also overall have dopamine target directly positive hallucinations, which contributing more negative anti-psychotics receptor and time disability We none time. are of and and disease. for are with efficacy typically be acute only negative them which more of over episodes and to positive burden frequency over the fluctuate symptoms. to psychosis can

we need a with prescribers, for new level options therapies. Additionally, of a of among treatment and recognition low believe the growing satisfaction there is current

So indication. for of action, states factors, is current clinical given substantial effects of targeted on roluperidone mechanism and these the differentiated market from the its treatment the target believe we course that drug is and

phase maintenance the turn in in over As or of symptoms stage treat to the Geoff. chronic that, the I a it targeting products And late with unique it’s monotherapy pipeline to schizophrenia. disease, of will negative

Geoff Race

a Rick. XXXX. XX, this issued the we more release found were of maybe December to Form first December A quarter XXXX. million our and results as in and detailed securities ended today. you, XX, million on Thank results Report our summarizing as of XXXX Earlier earlier discussion XX-K our December of operating morning, SEC press the compared with year XX, marketable $XXX.X Annual filed equivalents cash Cash, approximately for $XX

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

primarily stock-based During connection public company in million seltorexant in of with expenses million Minerva offering under million were incurred co-development co-development and ended compared $XX year due and the the to expenses license research non-cash million development XX, million the of common These R&D XXXX included expenses proceeds quarter $XX.X revenue development stock, to in upon $XX.X Research XXXX of program, December payment XXXX. Janssen. common under cash with reflects million warrants, unpaid in expenses ended from stock balance in July and the $XX.X license approximately were personnel expenses and the Of a of XX, $X.XX was and The administrative the December the of and during received of professional upfront agreement accrued costs effective diluted program, December $XX.X fourth in diluted Phase the Cuts of XXXX. and the million loss or the actions the XX, XXXX, net and general expenses. and of $X.X XX, an agreement on XXXX were from $XX share expenses loss under the increase partially completion increased been for G&A XXXX in by known impact common $X.X date accrued December XXXX. MIN-XXX. $X.X tax a million XXXX $XX.X of non-cash legislation million an R&D XXXX loss the the a from Tax the the Act. XXXX. $X.X represents $XX.X $X.X XX, amendment with quarter compared stock-based net XXXX million to result were the for act million net the to Janssen, sheet amounts XXXX and was costs the have lower million resulted expenses expenses $XX.X a of increase Jobs in $X.XX roluperidone million on XX, XXXX. for amendment the $X.XX of forgiven in ended fourth income of and exercise the year to compared share of and proceeds diluted the basic of for year with in loss the existing to high exercise expenses. stock and agreement reform December were This compensation million and in proceeds company’s expenses, These at collaboration December for offset an significant in year in was the loss share diluted. expenses million the deferred basic per to quarter no Janssen. basic development increase XX, fees million or the $X.X had increase quarter and for XXXX The or for share quarter of XXXX. primarily commonly law. year fourth on and a to less XXXX net XXXX fourth $X an compared of XX, per $X.X due ended trial Net of basic December is million or fourth fourth administrative to $X.XX and December compared ended an the of The quarter increase Xa were ended modifications enacted of in as the expenses for increase per the reported of in General of income to income for Net per compensation a clinical year for company’s

As a for $X.X XXXX. year of for for taxes quarter zero of million result, ended zero $X.X XXXX to December was benefit ended quarter in XX, fourth the December the for fourth million was to in XXXX compared income XX, taxes compared year the the Benefit income XXXX.

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

Operator

[Operator Citi. the first from comes Instructions] Our of line with question Joel Beatty

open. Your line is now

Joel Beatty

and for taking morning thanks the good Hello, questions.

to to about on a are enrolling of can being with you trial track as you of you how you for and Thanks. the of any to you on the is one adjustments first are The the enrolling? patients MIN-XXX, types enrollment discuss appropriate trial little patients or have bit able are changes make balance types had feel for the

Remy Luthringer

and Thank Remy question. you, this answering Joel

the possible we X the close it already question, mean had we have Phase you Phase X I I because that obviously Xb chance, a is as think of should end have as to run. I lot a the clearly be great this discussed mean, because at know, FDA, as the Phase meeting of with we was study

of from Phase dealing I to as right to in we XX% order stability schizophrenia, this Phase hint and history in with will who in from a the the in the because of get to to are need could Xb when the in said to enrolled This mean everybody the here symptoms. you you patients Phase access efforts lot their of will order be good put ensure history, X. have the the learn design have the part about we show obviously, lot symptoms knows we that patients the really negative a coming of order in we patients So a around the U.S. really X

focused right the this that team up have on patients really has I think So, in will with the place come in a with include lot patients has to in this we really same the and patients sites U.S. order – all right we focused the in Europe. as the

really the decisions, we And we are sites, in So, identified really obviously I with decisions screened doing are by order also we patient helping we is are is that very to the the same a that we final unique this to this obviously, a site of are carefully, doing but is phase because here, following take what in each Xb. is really doing. the helping here are right very one What PI the we mean I are as order ensure important. site, the it’s the mean also the approach we in had time quality the something Phase

continuous We PSP come of the in in right have really to performing is up to CGI outcomes, follow the PANSS control each and the order patients. particularly how order key this site the with obviously scale,

these this question, could this, not but I because thank we results. are but really Phase be really that aspects really in key to can I time you same again, and explain pleased And to success. from do reproduce a much Phase want for take the It of we again, are mean, the Xb account. as the really is X taking lot So, really into I all longer, we really learn very key are the the this

Joel Beatty

you Great. the other in And of the Thank help of depression next and insomnia expect results half you could or to whether the first that any agent differentiating in action to discuss you. lead then of are features coming on and is question year? that the seltorexant, mechanism one

Remy Luthringer

Yes.

in And pathway who pathway. interested is personally I was thought I before our about I this. are is orexin-X antagonists, know, is dual we mean, from so we suffering stages to or physiology specificity and we have restorative the sleep already also to on put clearly, is molecule the is call insomnia, molecules, molecule is mean, be this effect molecules think that we they in place see way obviously the in it but and specific in help on a demonstrated orexin-X Janssen, with and of why the to I maintained. team hope in in I which to able sleep. data are mean from other important so seltorexant to And pathway with more measure lot what data other the a objective enough the an this mean here induce different the enough polysomnography, started you is this to sleep And collaboration patients and and out lot obviously, question. pathway interested interestingly, a are sleep sleeps, antagonizing as it also order with the that sleep words, And orexin-X you need the orexin-X I of is So, whereas to is to have are just other to already have antagonist, preserve I have is development you all coming market, we deep

contributing We in people this on have some have be in effect this to when is sleeps. functioning. because daytime aspects, not they really sleep major no the up, of cognitive existing often they which during is they and with function terms treatments, have better better impairment of restorative there All wake physiology, you REM and also you that terms can sleep

effect molecule with much definitely extremely mostly with I mean, that this reason I mediate What specific going the molecule the safety to dual better via is orexin-X good this dopamine, experience something histamines. is think whereas is tolerability you clearly, is also effects profile when by about our via side and we the via or mean, mostly So, interesting we dopamine molecules. mediated the and mediated brings know have is our why. is that was is the our orexin-X profile several side pathway that like the And antagonists

brain of modulating – speaking of approach. So, the with really favor is well. are which on autonomic know signaling there activation there orexin as are when lot insomnia, is you sorry over-activated to also that least, orexin action, there And as of which you hypothesis when not the nervous system, of the impact speaking specific not depression there stress, the Last is mechanism is you about the the know, level in brain. orexin-X but are is something is – is have aspects extremely when you going that and some somehow

You the which is have which which to all controlled pathway. hormones, also also stress HPA is by orexin related the is axis,

molecule, not So a the by is end a this having systems described, mode I insomnia, controlling orexin-X up with of you which something this direct specific terms has over-activity the these in really efficacious I we molecule, avoiding different extremely on think is and have of is which and but antagonism demonstrated. dual just this also having activity having orexin-X effect also and activity by a

think wanted So, going have are I molecule really this development really these on this with we reason we Janssen. have and focused the why to really on

the So, obviously mean, currently the future, I is study ongoing.

like example to and insomnia mathematical that need important we to on have difficulties the today effects in is in aspects example problems quite cope with very for with is not sleep, someone available on and other complete to diverging very currently things have sleep exploring up standing a the we able several to in is to which that when effect going addition some this test something for these standup of will night the able But know on happens, all in cover side and already to but in particularly have molecules insomnia, cognitive you up because what have of we mean going is kind to with We we for depression and order the the also lot this depression. what and I are go is we he impairment, are to hints, well on elderly. back we wake we bathroom, insomnia going often the these have something is in he have

are lot I this think molecule, make attributes approach unique. which there of of a So, this

Joel Beatty

you. Thank Great.

Operator

next from Jason Securities. question JMP of Butler comes the you. with Thank line our And

Your open. now line is

Unidentified Analyst

you for in Phase there planned the are social that endpoint roluperidone, speak for trial? Hi, interims X taking it’s the I and performance on in Thanks then and of Jason. any can the to secondary [indiscernible] questions. personal couple importance had

Remy Luthringer

improving as to everyday what basically I and the is score drug symptoms up taking approval. So, able to in or morning, effect being this case. the get mean order more mean, is cope clear patients shower any moderate endpoint it everybody, everybody grant mean X obviously primary very This is again really also is is make This stated life. Phase that it by functioning the mean clearly, negative I like are is to symptoms the to improving roluperidone important extremely in clear drug negative showing a is is things hopes social that said just in I Phase same because more improving is have which is the active which study. negative of we that our this has functioning the is been improving the negative you of the Xb what with seen simple in I engaged a standing enough the and approved. symptoms always which

discussing improvement secondary mean by patients. include PSP. I obviously decided And functioning how why have of really or on this like to reason the focusing terms is is FDA what with we endpoint in this So is the good to in the PSP

So, some sub-scores you the have obviously if are you PSP of is hitting you score molecule. and understand you overall obviously overall if better have the what effect will –

are I you consequences have life. mean improving layer additional the some symptoms, patient not this to only the are prescriber, you patient is If which that and also the really to to positive explain and will an you but families of we obviously in everyday the this, these the have

approved Phase made an the So you again remember but had related the effect also this and PSP. is why on the put drug hitting reason that secondary we is is we only the as endpoint to and the is is get Xb PSP, primary

So improving definitely is the mean molecule that we I know function already.

this end think at will the day. the be of an I value added

Unidentified Analyst

And interims trial? great. then there for planned Okay, that were

Remy Luthringer

Can did not I you understand? repeat,

Unidentified Analyst

Planned, got of interims? any interims Phase X, kind the planned for do you

Remy Luthringer

analysis no we No, XXX no planned, we study a interim this not. analysis got question and really patients if so have I planned, the definitely have is interim

Unidentified Analyst

have in trials or seltorexant I MDD interims are Phase the question for there the Xb those same in any either insomnia?

Rick Russell

yes in the for which the dose I forward move ranges are are depression study and into planned, doses seltorexant, are Phase study analyses some doses which So, the to mean the better of because the there indeed is in one or insomnia define we interim will objective X.

is for necessary. these planned two adapt those studies and Part to you So is the an which B for if of there can indeed analysis study indeed interim

So is this in we defining X. reason as in doses into why the used be have the adequate forward as be order moving interim will analysis which possible to Phase the

Unidentified Analyst

great. on questions and you you going couple of MIN-XXX, the Xa? And gating the but know I that the with had meetings factor Xb Okay, have shortly, did said a regulators I what’s following are start to Phase starting you for trial Phase the

Remy Luthringer

not going different no mean I why it’s No, technical. there we SEP committees good the so get I reason mean actively is and on approvals, is the not approvals these purely is get which factor this these something is all purely technical, to I from should mean and

sites. the defined have We

and we U.S. sites. We study where a have defined be also this the the Europe split will have U.S. between because

to purely close time ready to it’s this study. prepare them and we have by to first So are very in be patients again, and the

Unidentified Analyst

Okay, great. Thank you.

Remy Luthringer

welcome. You’re

Operator

Thank you. comes [Operator And line question with from Instructions] Biren our next Jefferies. the of Amin

now Your line is open.

Biren Amin

trial you to Hey on optimize clintrials.gov taking study there? of Yes. what for trying bit are was that a formulations to with three initiated can Thanks. that you at seltorexant and questions. look the little just recently, my about I there a that Thanks objective different guys. talk noticed

Remy Luthringer

So, been previous studies the formulation Xb finer very formulation about trial. that and technical This formulation have forward anything Phase pre-formulation as particle of we are optimize to a the moving in the we currently trying the used are more is clear. using be to in not I forward. size defiantly mean, trial trial we which evaluating moving the have

the aspect, CMC purely data not answer as this mean, aspect pharmacokinetic for But the CMC of but a be I of molecule is is and in the have filing to the I purely terms is this again, size this particle dossier. to change CMC. So, it to PKPD and molecule, the necessary the mean for does of the prepared

change to efficacy So, indications something, nothing the in is which to the the as want clinical dossier. definitely we related CMC for we or to to after. change going purely It’s manage order are

Biren Amin

are MDD think looking how for Are non-inferiority about then Thanks. to should we those objective objectives? the And is superiority at you it quetiapine for Okay. you quetiapine, the comparing to the studies? or trials,

Remy Luthringer

indeed level, the versus study. the descriptive all is to to is Phase two exploratory order not study an the necessary the elements quetiapine going think molecule a add-on I are really of It’s answer order in after of the This the the have study. on design to study right order in compare we add-on X our aspects. in

So, two this study between MIN-XXX, study to extremely well exploratory order in seltorexant differentiating the studies which sorry, seltorexant powered. is say to an other pickup and are to aspects compared quetiapine. between I – This the wanted

So, this program. clearly of this be hypothesis is to Phase X the so study set and the purpose will which in included

Biren Amin

seltorexant reading which you timelines in And out anticipate just across three of Okay. studies, then first? the terms

Remy Luthringer

three we what recruitment are studies XXXX the be first good we think readout are the clear I one will mean moment, first. we of the the it too I is the for stick out recruiting early of reading mean study to this that which will is three of to said the that be and trials because said early sorry. is really the always for I should news. just in well the And say What half have nevertheless I is part is

early, So are very but today of well again, I terms too recruitment. thing in really think it’s going

can So, say this think. today, I I is think, but I

Biren Amin

you. Thank great. Okay,

Remy Luthringer

much. so you Thank

Operator

questions. Thank you. am further no I And showing

to return So, session. Luthringer closing the remarks. call to I Remy would Mr. Q&A for any this does conclude like today’s

Remy Luthringer

I to give for forward very so you much. Thank really an time looking close in your and the Thank Thank am you future. you again. update you,

Operator

Ladies a Thank and gentlemen, may you Everyone you this your today’s concludes and once disconnect. now again great participation day. presentation. for have

Minerva Neurosciences (NERV) 12 Mar 182017 Q4 Earnings call transcript