CERE - Earnings call transcript Q4 2020 | Cerevel Therapeutics Holdings Inc

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Operator

Good morning. Welcome to the Cerevel Therapeutics Fourth Quarter and Full Year 2020 Financial Results Conference Call. At this time, all participants are in listen-only mode. [Operator Instructions] Please note that this call maybe recorded. I will now hand the call over to Matt Calistri, Vice President of Investor Relations.

Matt Calistri

you. Thank everyone. morning, Good joining earnings our call. you full quarter year XXXX us appreciate fourth for and We On from Dr. call, today’s you will be hearing Coles, Officer; Tony Executive Chief Dr. our Ray Officer; Chief Sanchez, Dr. our Medical Yi, Chief Officer; our Financial Renger, John and Kathy Officer. our Scientific Chief

would to which During press current views this like our product are performance well to Tony market available our release to XXXX you SEC corporate updated our I of our and CEO product statements risks as we it the trials. our format and that future be clinical specific on and to performance, will attributes regarding our We Cerevel please our strongly benefits over an potential conditions, detailing presentation, as encourage uncertainties. the from I today, as the forward-looking hand call filed refer and morning Coles, our with Chairperson activities we forward-looking to to and now both website. statements, development making related outlook. events including remind provide information will you that overview well industry financial our reflect that and Dr. and as of candidates, Cerevel’s and of review the achievements and of of timing

Tony Coles

and you and forward look to our Thank Matt outlook call Thanks, good us this public morning, achievements for company. I aligning XXXX all for as from joining for our everyone. year. first numerous a quarterly results our

Here at become goal to the premier Cerevel, remain neuroscience company. our we steadfast in

with the into with yield with a deal This year, XXXX. programs lead and $XXX a XXXX together we have PIPE addressing advancement for programs to of we Xb we at targeting in for approximately in organization for end we and priority. just been of $X trials years groundbreaking X of in which expect for ARYA response patient small molecule from have start neuroscience. rich our have and subtype in transaction, approach quarter in founded X of of PAM the or SPAC, II, continued In Phase we along XXXX, XXXX, Meanwhile, respectively; majority that investment as XXXX, now of a XX at enrollment our deep Cerevel Darigabat XXXX, billion our department. generate of employees passed questions combination more thanks momentum and of vexing enabled most provided CVL-XXX. and have X and Pfizer. continue Phase portfolio by trial current benefited safely transaction readouts was the net pandemic, In XXX that recall, to trials our proceeds tavapadon safety that over and XXXX, of am of portfolio, fourth that special cash completed up that growing of in our onset for may over all in Parkinson’s; trials reinitiate the capabilities we you than our COVID-XX continues. to able XX the leverage to receptor MX-selective clinical of schizophrenia anxiety R&D of end As our this we programs some with our always Within creativity a company, X XX includes a proud the the quarter in to work million. X our as data to is business company, our from our Phase expand GABA the will epilepsy with in clinical by acquisition as modulator, allosteric of our go-public say a all us employees of team, and purpose the growth top end hard dosing trials, runway fourth the our positive This I to X the

We have CVL-XXX for two Darigabat. year key coming this and later readouts data

with and feet headquarters, our new foot Crossing Cambridge expiration XX,XXX over targets. efficient square square discovery, the drug are of XX,XXX of enable lab We opening complete speedy space and to

forthcoming on as leveraging focused targets preclinical We for INDs technologies programs artificial and drug have and to we for gene-editing neuroscience new multiple are such identify diseases. intelligence enabling

proud far additional new progress. we epilepsy, ask pipeline on is period like are We anxiety, of now clinical Cerevel and provide bring to to our in with transform we time have a treatment review what Medical challenging I Parkinson’s. at Officer and diseases to come would such Ray patients our of Ray? possible efforts, as Chief to detail like neuroscience how schizophrenia, short our in options Dr. To seek Sanchez,

Ray Sanchez

Thank all to of you, morning Tony and you. good

we a at and have of and molecules. stage As you preclinical broad clinical pipeline diverse Cerevel, know,

Over have the candidates made great in drug our course strides of advancing we clinic. the into XXXX,

the our CVL-XXX, with our treatment. upcoming a with will compound Tony measured trial. trial all is by tolerability I on data in readouts. potential to over or have score the Xb pharmacodynamic I ascending of to As of mentioned, the placebo-controlled, is like and start we clinical multiple a in allosteric our modulator, PAM’s two as antipsychotic A part dosing and of PAM, doses is ongoing weeks assessment Part which Part patients update B double-blind you in patients begun schizophrenia. total currently trials. safety This of Phase evaluate would each the MX-positive designed trends a And X detect is to in

Part clinical to differences trial designed identify is completed the not in of midyear for later will in Phase in that magnitude this a we Although significant readout have the trial to We timing to efficacy, stage the Part of XXXX. data effect our currently to refine both dosing can hope are now statistically parts we B. A trials. demonstrate Xb To-date, inform and design

and we trials. Those complete receptor appropriate an the discussed future GABA great anxiety. CVL-XXX. to like January, seen we allow in with PET will during GABA the A benzodiazepines. also which to our expect is αX/X/X-selective an In limitations PAM, characterize PAMs studies hosted program occupancy to us without benefit therapeutic for to receptor event A and provide in Darigabat detail fully potential R&D We for select compound with epilepsy doses Darigabat the data non-selective clinical

We are ongoing in both and clinical trials anxiety our currently in epilepsy. dosing

Phase Our second to half read readout trial in expected in year. to is anxiety XXXX. second of X REALIZE our focal in the acute the proof-of-concept trial this half is of proof-of-principle X expected And out in Phase epilepsy,

tavapadon, the For clinical trials, trial is program X as also our known TEMPO ongoing. Phase

to X stage continue dose trials, Parkinson’s. TEMPO-X the Phase Parkinson’s, stage of X in in three in and early TEMPOs We X and all late

dementia-related second this would data is X therapy CVL-XXX in indication the X half a publicly pursue to month, we This before, CVL-XXX. haven’t DX/DX time Since compound in We apathy. quarter of of from and and Xa second agonist, from TEMPOs both new of trial for data to the a half through like walk indication we expect to IND in also take We enter with TEMPO-X clinic plan the an approach the I state in and discussed begin novel to our disease today Phase year potential us. CVL-XXX, first to the in an this as partial a that next for XXXX XXXX. exploratory this you submitted

of the – presence decreased common functioning, institutionalization mortality, accompanying caregiver maintain medications. of XX including the to dementia, has predictor quality for Page personal neuropsychiatric related shown to this uplifting today, increased dementia motivation eat, nature associated also most half unmet to see and patients significant. turn million apathy is The of almost with is will you strong a presentation comorbidities that be dementia the apathy XX now of you normal most a Despite life, morbidity If with condition, of dress, social symptoms, well Apathy to a the and These progression. and as represents result emotional are apathy. It debilitating of take been in daily medications currently of medical and relationships in disengagement, is with early need including reduction and in globally. significant related treat of hygiene responsiveness. no interference as loss disease area constellation diminished well-being interest along symptoms to burden. in there a motivation, approved among personal the Therefore,

neuronal at response believe play symptoms functional Turning of DX/DX could lower to XX% Page receptors, CVL-XXX DX/DX a motivation pathways CVL-XXX a agonist to XX% the different up has a profile This dopamine response. it apathy. functional complex dementia-related level has address tavapadon now an is a receptors the potential makes at agonism to for dopamine DX/DX partial control we and treatment that Pathways them that XX, cause slightly of constellation to the of CVL-XXX drives from modulating Where approximately a potentially optimal that role. to key compound be feature tavapadon. reward. partial

has as treat symptoms path and regulatory in to We to demonstrated are the with an apathy, of development the neuropsychiatric development dementia, interacting agency achieve interest dementia-related to therapies indication define the apathy. in including FDA clinical plan of the

Our of planned patients apathy second design who step trial. the objective half second details is Xa XXXX. and diagnosis the with CVL-XXX year, of XX dementia. significant a tolerability doses primary in in an of of first exploratory of the CVL-XXX the Phase in quarter the of trial data initiation presentation with of clinical expected our this Page pharmacodynamics safety, It mild-to-moderate is evaluating have trial, two a placebo-controlled XX-week, double-blind with randomized, of fixed and the of clinically the

and daily three arms, interview meaningful placebo. include rating a CVL-XXX inventory X XX domain, of has dementia an daily to enroll patient’s clinical and important provide be think potential CVL-XXX, and the to apathy neuropsychiatric apathy assessments scale, novel to is the milligram Several the their utilized that in apathy treatment. goal scale. measure into dementia consequently the milligram and millions of caregivers. Our during will patients evaluation X apathy that patients indication the to program severity the changes These of is benefit We addressing

progress Overall, are forward the our program. pipeline. updating with continued progress with on We our are pleased this very of looking to you we

and prepare We for tavapadon, X to initiate open our X are lead to extension and on trial Darigabat also our execute we CVL-XXX, our including for ongoing Phase trials label trials as programs, clinical continuing CVL-XXX. Xa

early extensive would Renger, an I pipeline. Dr. Chief of discuss our discovery have earlier we these programs. some Officer like ask Scientific Additionally, John now to John? preclinical to stage and

John Renger

to like of receive minutes updating you that In we or Abuse, on Thank everyone. morning cooperative support Drug an a from disorder. grant NIDA, announce would development few on use CVL-XXX, the spend to expect pleased opioid to early I our National Ray am I funding particular, Institute the you, to good pipeline. and

is is activity of block in both cues. brain, shown also reducing translationally subtype. substance receptor our the simultaneously As you and has receptor encouraging opioid inhibitory CVL-XXX nicotine DX CVL-XXX recall, both within which use antagonist, the models relapse using DX DX-preferring cessation preclinical signaling of signaling while may dopamine relevant designed to and induced

our of receiving the X X Cohort the single-ascending sufficient of data trial dosing clinical Phase concluded the we healthy trial. in CVL-XXX of purposes after dose volunteers, XXXX, During of for intended

are and for compound. this currently of data continued We plans, evaluating formally development that

as excited about on in disorder. looking are important I the potential our for continued XXX an substance forward progress. therapeutic use We to you updating am option

and opening Crossing efforts. our as a positions, discovery of facility, our scientific Cambridge intellectual to focused are lab property headquarters, bioassays. with square novel essential leverage questions, speed square core development Finally, greater feet are our discovery, XX,XXX the Within of space foot wet including enable expertise capabilities, establish mentioned, to program internal drive own our on solutions of we will XX,XXX we and Tony internal complex lab drug unique we nearly drug flexibility, the

will and pipeline, in discovery pipeline vivo and early also lead and one multiple human support early the cell for CVL-XXX. submitted for with respect identification to lab biomarker models, iPSC with our capabilities addition programs models our infrastructure Importantly, our to our INDs activities, genetic in synthetic provide compound already forthcoming, formulation both to

CVL-XXX, in therapy stating in an potential during As our depression use disorder substance year. IND for second quarter we antagonist, opioid as receptor and we and plan R&D outlined we the our January, Day this submit Kappa to a are of

for of schizophrenia, selective targets multiple conditions. areas, In neuroinflammatory addition, evaluating subtype modulators enzymes including as PDEX we depression, disease and are

selective a of inhibitor We are by this the for end PDEXB to submit planning an IND year.

to two we work these on new identifying are potentially Beyond continuing modifying neurodegenerative for disease programs, indications. targets

are turn can and XXXX Kathy? updates year. our we over beyond. very forward I’d you to review and many to been now Yi, for exciting like Chief our as performance an So, has XXXX year to specifics outlook much financial and the extraordinarily see, it to of in Officer looking productive Kathy Financial for our Cerevel this

Kathy Yi

in and increased compared million infrastructure, headcount execution. pipeline driven associated cost The increase organizational administrative in activities. $XX facility of other results, the runway. support and and and Thank compared lease year’s new start XXXX. Cambridge were also R&D expected one-time you, moments discussing investments I expenses to to our advancement and of Starting to with programs, as in the growth, Crossing. in to $XXX The John. expenses headcount spend million million primarily attributable financing in financial our in position General discovery cash costs will were of a of including the our support $XX to will our continued by $XX XXXX and by primarily expenses included on clinical in transaction XXXX our higher was ongoing related million in million then of last results, and was operating early with IT for initiating for expenses expenses headquarters our well commencement few I XXXX G&A completion a investment clinical dosing to our go-public approximately lead trials R&D XXXX. in as increase all efforts XXXX $X.X

of As as million and XXXX. equivalents XX, to cash $XX XXXX, compared December of December cash XX, $XXX were million

was stage Our XXXX quarter in continue to This allowed position at enter very assets. raise to and balance completion a the earlier us will approximately our net with cash go-public strong bolstered transaction develop yielded in sheet of that has that the million lead proceeds. of $XXX our to XXXX us programs on execute enable fourth

investment Looking we up as our tavapadon expect increase expenses this patient trials Darigabat late and in discovery enrollment our early to stage as we efforts. forward, ramped as additional for well R&D year in

stabilize of this infrastructure our end state. through a organization as to the year expect steady expenses in G&A growth We approaches

these next the readouts balance our few value we important potential years, looking trends, to our cash XXXX. we multiple Over are into on expect including fund to events, year. data forward two creating Based this operations

think our and sheet bolstering to opportunistically our support to continue portfolio. creatively about balance extensive We

readouts conclude. our preclinical now clinical to assets, data over We would we XXXX, provide to progress back have which up as the XX continue ample hand and for and to creation between call I like now to opportunity X to value Tony pipeline.

Tony Coles

Kathy. Thanks,

can see, broad, an Cerevel Cerevel pipeline I by significant call at track aspiration you year with year new to sharing and and momentum. neuroscience with achieve premier entered was potential our opened and remain deep As have this become we XXXX that on rich of for we today’s company here extremely a to certainly the productive ambition, therapies.

seek of needs At expertise and have including that millions today, to diseases, patients schizophrenia, considerations. as to new substance underway ultimately Cerevel, the use to the our with programs patients numerous Parkinson’s unmet portfolio anxiety, deep have and neuroscience dementia-related as and them. are We apathy address to us epilepsy, high we for who bring disorder need neurocircuitry leveraging Ray John highlighted in our and newest unique medication advance for

programs. thank and certainly do clinical thank that thank we in open I positive in our With support mission. not I operator, and so to Before also to our want true making I employees a our without and conclude, questions. to development now we want participants the also lives for our floor are caregivers physicians, on can all that, belief who you. committed investors patients’ of It is this the their can impact for

Operator

[Operator first comes question with Paul Instructions] Our from Stifel. Matteis

Your open. is line

Paul Matteis

Great. on program. Thank one apathy I question your schizophrenia much. dementia have one you and so

might driven, of is p-value PANSS guess that what On not evaluate on as the and into a would I go apathy could if was margin you to is compare plan I how patients. study wondering hurdle? currently to the you to given on little maybe the sort the readout something of reductions then you in schizophrenia XXX, the selecting bit think that saw for best of deeper a way kind data seeing agree And you that the these program, about

you Specifically, specifically to more specific that apathy the how direct symptom this I think versus would and a this antidepressants, patients also study about or homogenize do way, you differentiating are in you you had depression population how And Thanks. to? maybe guess, in depression really agitation? can talking include that want etcetera?

Tony Coles

to questions. Hey, and to that familiar, not let are that make there the still both both I a for study well know in may comment. questions. me patients And others Ray you But Phase thanks, but quick is going very ask some listeners a appreciate are I take am Paul who CVL-XXX just study. very Xb schizophrenia

goal So, decisions next our the Ray, trial primary think about about don’t how at that and And development? looking the for particular Paul’s dementia-related about of steps is move safety why tolerability. apathy. – and you making to we question But will talk then we

Ray Sanchez

trial. question CVL-XXX excited Sure, schizophrenia the a in Tony, regarding so see to

have So, the so what then see reduction would of don’t can the the Paul, to look our a it’s that use or look to of PANSS trials. phase want like good of the ideas should We We preconceived data we information question. any inform like. totality design next

what want course don’t juncture of forward. speculate I the So, inform this moving to that at us look what will like data and may of

the trying of to you apathy apathy, critical. good that going diagnose question quite is a be it’s dementia-related with terms know In as patients to

We population, moving one we the pointing out, significant to X working new for apathy and identify that but with understanding as greater, raising important diagnostic using with program path To in are so we considerations critical and all as really ISCTM forward. two, of really suggests what criteria agency, delineation can which execute domain really to endpoint an development registration, NPI or the correct which you of group. forward correct early apathy will is call on that the as criteria been a are I for diagnosing the score enrolling but ensure and just using are mid-stage develop of Phase patients them apathy, that the trial. outlined we in be we dementia patients, are the looking which based the you the in are this critical And Xa choose we the factors that has one, that

Tony Coles

Great. Thank next you, Operator, we Ray. why question? take the don’t

Operator

with Michael comes Our next question Jefferies. from Yee

is line open. Your

Michael Yee

as I on XXX Thanks. follow-up guys. Hi, ask well. will question a

mgs what differentiate of you and can doses? Given some makes mgs is on And said about idea receptor how you what describe you preconceived and XX have have around to would no XX two and the BID thoughts just those exact you that on into notions, much occupancy delta maybe an Karuna there right just a see result? push up want benefits. XX forward don’t to I the consider tolerability, numbers data, read to and just healthy too was to nice want would XX point you the it’s that like pulling QD

you little So try rather the and bit, a between bar, some just doses? and Thank two differences maybe delta you. receptor to healthy talk occupancy, the than that set show a just [indiscernible] particularly

Tony Coles

Ray. Thanks, for Thanks. don’t on be You Okay. the that question. Mike, one? take mute, why Ray, you may

Ray Sanchez

cut question Michael, part it. of part again? you that could it out Apologies if of repeat

Michael Yee

mg can doses about around those the occupancy, question in just a have differences two? and The talk XXX see receptor you to you those thoughts XX and the study, those mg is what doses, two two would Yes. the QD, between between BID like XX in you

Ray Sanchez

Okay.

John two antipsychotic receptor to at its with levels it two – of model effect understanding that parameters, let while its receptor those QD needed talk, the efficacy would in a have can to of will that speak and terms of its the meaning is occupancy, a – are as model really looking XX reasonable achieve the at those doses. those PK but John BID we sustained the the looking in doses occupancy therapeutic a order I more So really and of of profile, throughout function then but both day profile pharmacokinetic versus sustainability around achieved the in Michael, course

John Renger

question. for you thank Michael, Thanks. the

So, to enough believe projections based can receptor BID achieve XX what that XX% milligrams occupancy. we is on is actually

over doses nights to over occupancy the course, we the the the the the looking XX Of available well XX and BID as maintaining exposure there mg daytime drug next intent confirm study dosing QD mg at morning. to are receptor What receptor of two with of a is extend occupancy XX BID is is the really with hours as that.

hours dosing of a whether of range receptor have Our to us in the the But are PANSS over test other really both occupancy as will difference upper plan is this end to score. the in to is we we help importance receptor a will whether point drug for an and inform going between the the you and a know important to at occupancies that once inform and day formulation help what forward need presentations, XX the the two equates need maintain improvement dose believe and need of milligram us to on we XX dose the milligram as that we efficacy. understand XX

move dose look what late understand program the to cover we stage And to we really the understand and to rest benefit forward a as range going so what is to appropriate of the really really want range where the like take to ratio is safety the doses dose have safety and forward. efficacy into we

Michael Yee

Thank Great. very helpful. That’s you.

Tony Coles

Okay. for next will we Operator, one. Thank the question. the take you

Operator

question next Suvannavejh Goldman from comes Our with Sachs. Greg

line open. is Your

Greg Suvannavejh

Thanks financial and Hi, outlook. this apathy for two and good more taking dementia-related morning. is update my so other on I’ve on the the morning. got the is questions. program for One much the

And the has it’s am Thanks. new in thinking just then some what evolution for the good R&D on run-rate fourth just a in I your year? see with been the be think lack SG&A you at XXXX? give relatively been is studies success been for you quarters the terms have that number, with XXXX a bupropion. we has the really sense the and out I question, quarter in we how at modeling might the I a my of to how that’s interventions industry has On us dementia-related given then to And that area across thereof about asset? in what look help the that or second for the increase look therapeutic just and but that with donepezil R&D of first looking me, at do can and seen wondering history is apathy? four throughout should question And a frame steady opportunity and side, come

Tony Coles

thank the Great, we take and study. apathy, question and therapeutic then first lateral the Kathy, around you financial don’t Thank the standard will care questions. why you. for we question to of

Kathy Yi

Yes.

your R&D Greg, think G&A expenses, And on address, in the will question year the expect. increase space, coming enrollment. say to it steadily we quarters XXXX. four increase I patient should think for as that it I QX the So the would be I we was throughout should In our something a good representation the

Tony Coles

Okay, is trial we with the headcount will on spot The spending I discovery the obviously, behind disproportionate efforts. am are add Kathy likely expansion other the we programs, the really good. Thank share thing but have support that of is programs year it of our and up some to focused our assuming only you, every add progresses, Kathy. on running, we that. would the and I is as got is, clinical

suggests we So, Greg’s make first and the Kathy that the very keep in are Ray, you to to currently want programs. do about careful want used a sure in apathy? question will SG&A take on eye as investing therapies the are we

Ray Sanchez

a Sure, for you thank that. great And question. Tony. you. It’s Thank

call, apathy more debilitating earlier more to I the dementia. with So, as something being be in as the in that’s last something is quite mentioned recognized that and patients can decade

the The fact at there if well look with no therapies. is no historically, really reason established that that that inhibitors, proven that you the SSRIs but treating motivation our really is no And are but effect not and really anti-cholinesterase that, approved also apathy. have in However, work it they SNRIs used for been benefit. to address the is there as

apathy But patients some trials in dopamine been they that improve have some of is modulation that’s supporting obtained methylphenidate. done the symptoms signal that the can there from worsen apathy well. with fact, hypothesis with evidence dementia cases, been actually as In may in

norepinephrine As significant done inhibitor. And dopamine you that have trials show know, effects there. of and reuptake that that’s there couple are the been

mesolimbic its the which dopaminergic that neuronal because are that XX% that is and loss. more brain, work of our level reward, and to that don’t areas agonism actually under hope lower roughly brain so compound, this the will partial of of of motor suffer related the same optimally producing profound And the the pathways it to in balanced with motivation compared operate tone dopamine areas from

used benefits nothing currently so And that not are we the thesis. again, why our well. which this and agency forward be this approved will is of with closely patient those to we medications impetus effective, program moving moving about hope are in is and us are the But that’s underlying show working population. able why is that forward And excited as our the

Greg Suvannavejh

there the Great. Maybe how program? to quick with novel in an is about a still – endpoint? is are there or just terms a you for follow-up think thinking it endpoints, a FDA that development universally clear clinical opportunity is opportunity primary to endpoint the you an that’s about are ongoing embraced or understand discussions just on efficacy on of I still And but creatively

Ray Sanchez

Right.

the neuropsychiatric NPI-A inventory, trials the and methylphenidate at the the apathy So, use global looked score. they

the shows a going consideration scale broader that some to and that into series endpoints, NPI-C, which be will to give best to apathy. mentioned using of approach other in improvements will burden most the takes really caregiver is us an detect idea I probably sensitive delineate call of the be in are We the including which a earlier one

the validation would to So and way in the the incredible look the their to what with necessary this data, is and of closely moving teams reasonable work this be fact, endpoint collect an agency Phase trial at in benefits apathy. the evaluate trial, it Xa that therapy the to of primary developing that’s would is do forward of conduct really that what work, ideal be exercise that will heighten part really a improvements

the naturally literally with are forward carving agency to we path closely working So, do so. very the by

Greg Suvannavejh

much. Thank you very

Tony Coles

you. thanks And Thank will we Operator, take for good. please. the the question Very question. next

Operator

Our next ISI. question comes from Omar Saad with Evercore

open. line maybe telephone is Your muted. your Omar,

Tony Coles

line active? Operator, showing is still the

Operator

sir. Yes,

Tony Coles

Okay.

Operator

Omar, Please un-mute. your muted. telephone is

Tony Coles

operator. please ahead, Go

Operator

no the last queue. There The are left further questions. person

Tony Coles

Darigabat anxiously an to in just continued We wrap, all We midyear, promising and good. Very the to up on there. the joining very the the morning. And year. you equally progress this is CVL-XXX move study XXXX as It we had thank in Okay. updates us a shaping fronts, anxiety XXXX, great our year. results providing on await successful for guys be some we through problems look Well, was of to healthy forward volunteers. technical

So thank rest the for enjoy joining day. guys and of you us your

Operator

the Ladies this gentlemen, does and conclude conference.

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

Cerevel Therapeutics (CERE) 24 Mar 212020 Q4 Earnings call transcript