Arena Pharmaceuticals (ARNA) 6 Aug 202020 Q2 Earnings call transcript

Good day, everyone, and welcome to Arena Pharmaceuticals Corporate Conference Call. This call is being recorded. I'll now turn the call over to Laurie Stelzer, Chief Financial Officer of Arena. Please go ahead.

Good afternoon, everyone, and thank you for joining us today. a our review results. second had we news you announcing issued quarter hope chance the to release We XXXX financial

the into straightforward, we relatively today's quarter guidance As unchanged, remains call. and will question-and-answer a our directly session on go was

on Head Munshi, President Joining Development. of Executive Research the and Chief our are Chris Dr. and and Cabell, call Medical Chief Amit me our Officer; Officer and

on remind uncertainties you that Before business. our that to be and XXXX we like and COVID-XX projections, our begin, beliefs, statements and I uncertainties financial financial making or including the plans, involve expectations, pandemic to risks events future about impact would goals, forward-looking related of its those and pipeline, guidance we'll timing our results, risks potential

uncertainties forward-looking risks differ these materially be could be risks involve our beyond assumptions, these and from disclosure press earnings to Forward-looking we statements of cause release our can All certain results description these that Arena, obligation to currently may disclaim in actual based found forward-looking latest A and any and to statements. and control SEC on available update information documents. statements statements. our are

turn Operator? to the over call the Q&A begin session. will to I Now the operator

[Operator Fitzgerald. Young first comes with Instructions] Our from Alethia question Cantor

Your is line now open.

on Hi, Emma Alethia. This is for

more COVID are wondering, versus they elevate? overlap? why speak more kind given to Crohn's the the the to execute in could UC, uncertainty in environment site you challenging Or Just study prioritizing might to significant be of enrollment is related

Amit. is This

up running. get than that any had program a It's Chris Whereas, more less me the elevate can initiated. complicated and stab is cultivate take add not and differences that, big elevate the color. Let or at to any

the programs running up programs bit cases, difficult in sites. before, in any we've substantially that's environment, little are the being are programs any already in and initiated that anything of more compared in COVID difficult more to are covered or some a this environment that said terms So and

I the sort short think that's answer. So of

Amit comment, No Yes. said, exactly right.

might well, where and obviously, derm of then UEN all scenario Or answer are independent next atopic one success is I alopecia you Just choose there that this year, in looking ahead to to might this really But a prioritize but mean as those COVID assuming kind one with over caveat. the another? crones? follow-up. year of

about two They're think the this franchises. the in then franchise of with got the independent. the We've We're out three indications. indications building terms with GI and we derm

moving all they're forward. So

Thank you.

from question next Suisse. Our comes Marty with Auster Credit

open. Your line now is

of for chance to the give just I'm thanks the about was the of kind talk a question. going evolving. to of taking I ADs Yes, wondering you competitive the you landscape kind in of Amit, sort rip if overall here. could

AD. the where lead see in unmet obviously, to you kind class ulcerative little and could like the environment about oral data that kind bit a of you're you here colitis, competitive player when If need etrasimod in proof-of-concept the And for Phase looks then relative delivering in II of novel you're what the SXP for talk agents?

to of closer has set? data this kind about successful to thinking forward kind is that how going a the get curious we bar So drug you as commercial have what of

into landscape. the Let competitive directly a me question, because the leads of with question start it your is bar back part which first

patients. we do area, would We enter at in do of models, we scientifically but we important just animal a a both in terms for difference it's make how occasion. work understanding market an desk and from new also reserves, work, these the a recall of point look new a therapeutic product environment the that lot view, to the a both extensive of of amount think I just time every

placebo, to know, if you changes up teens relative In kind XX. the for the as some of of the inhibitors the from terms to of look EC JAK they bar, range you high at

space it percentage that range agent broad that Dupi's we've We penetrated derm couple an substantially that's a One, from market of a on has the research still things. And a severe market. pretty the success, conducted. to range. it's based tremendous wide think oral relatively number market would safety overall The actually profile anything a suggest has that JAK that commercially be So inhibitors. extensive small the a research in viable that of mono a atopic program despite is seen there two, for different open for viable

more to are aware, the say, to are to, well concerns gastroenterologists compared concerns safety much As dermatologists who are tuning compared attuned rheumatologists. I people safety most much think more

program. proposition So historically with etrasimod. sort We interesting here has a of we've I in where discussed, there's has there's profile what a a the that oral sort consistent home that's safety seen a run range, very once-a-day recipe and as with for a a efficacy of think

of physician and acceptance. terms patient in acceptance So

of that market program. were if commercial efficacy data, would to range, in very suggest something of in all research we important So our terms a onto again, able that that deliver be

Thank you.

question Suneja next comes from Our Yan with Partners. Guggenheim

now is open. line Your

my Thank guys. taking question. Hey, for you

I the The first is have atopic on dermatitis question trial.

So the has XX-week a a and follow-up X-week period. period trial treatment

weeks the I data data, be So will you for is, And for to the you include the will also show question have then XX endpoint? XX Or follow-up. announcing for when durability? XX-week you the a announce data

Our primary endpoint is at XX weeks.

after analysis is in are open-label initial off safety. be can between on data XX The this drug, the subjects really study weeks, will The into and they XX-week so And the remember, around extension focused that. and then XX enter that.

And data from insightful. future durability data open-label efficacy date. later the at the analyzing not be at particularly on, is we'll a the then week So XX

you then allowing any question what who I then trial, have data anytime When year? then And topical actually this any formulation. see CR move the it. are year to next next the And update? that could rescue? or will the expect is Or early When in patients? systemic And we a we Got on into need should or therapies? that patients happened final you

Chris, me take part, take first Let have and CR. the the I'll

Sure. Yes.

And we that no have of sure therapies So we obviously, is of for treatment derma other to like. impacting what could kind therapy looks there's the of obviously, allowed. kind want on depends and therapy, on it's what make strict, that atopic systemic controls types that it be systemic

so medications again, a ability And in discern are impacting ensuring just a our concomitant effective could be there and of that no be to what signal. can control terms there that

you So piece talk do want the about controlled there. that's the to release? main Amit,

Yes.

that's next bit air, up on still additional year. I back are given sites many into hope of and a in we'll be a studies the of covet. side, So data still have that CR little we down to the the clinical the in the early And year, probably to closed series Phase later

work, our which it the button down. And heading do be we'll has into more ensuring depending progressing then we're on-site the the formulation with and to additional physical that we again, So work, internal -- of some side CMC have availability.

you. Thank

MacKay Markets. Our with comes Capital RBC next question Kennen from

Your line open. now is

on Hi, Thanks Kennen. my This [indiscernible] for questions. all taking for is

multiple first the history going in with available space So one half. with is first question the data the CEK derma more inhibitor, selective atopic crowded

more I better half. coming second the think into are there

what atopic the competitive for fiscal development change a any enough as to each your should good data readout, current And space? we month of that in does the for think derm? derisk of strategies So upcoming the

And teens of Phase placebo. Phase a EC I efficacy measures, range there's trying apples-to-apples mentioned baseline fairly comparing compared studies we II looking as that, again, XXs. studies II as to into from range again, broad As high to to at just close at possible from the low and II be that looking to earlier, Phase changing the from see

there's few a class really classes and of drugs. is The So talk what people a range. crowded really JAK we're seeing just a broad inhibitors about

topicals seen those then class commercially the historically. side group There JAK on that to mild segment, them are there got in and topical you've in effect our of emerging And got Subsegment, more not for compete just And couple The of for of being PDX do the newly research. developed. PDXs severe you've a the given seeing patients based jacks profile You're got the are of existing the disease. course and well to a used market we've as you've agents. going inhibitors, the often agents. on probably very the one biologics, tend same the

don't and that you classes, number total of is terms really in think of So number three of of in total therapies, drug. classes think only you

of colitis drugs. them So the ulcerative And in an a talking classes of arthritis market only moderate oral that's etrasimod. substantially you're larger in with about terms none than balance severe profile few agent a safety of patients, of the afford to rheumatoid for of

JAK a some inhibitors have large the orals, you safety profile of of issues that the to the long-standing the If the a get of database in move have. Jackson, we you

forced You're biologics. move to to the

etrasimod are fill for And very So very few market. options. there is think very, a part important moderate-to-severe actually patients, of we this

you. Thank

follow-up have we question. a So

for the inflammatory in So new some would consider indications like indication neuro like you making pursuing? And MS? would which you CR, prioritize like

We formulation correct? about etrasimod, that the Yes. with speaking the is specifically of CR

Yes.

then GI the III move the bridge III the be should and the move indication. Phase with initial successful, in atopic for Yes, into indications into plan Okay. to is CR dermatologic derm it that Phase into

in So III. from etrasimod that's We'll esophagitis game Esinet derm alopecia a all nicely plan. perspective. or indications, the timing line here atopic The whether up it's or Phase newer will riot move the

have we concerned, intention the Arena is now no or As CR taking far we've as etrasimod right neuro neuro into portfolio, and the etrasimod neuroscience indications. any built

Thank you.

comes Our Leerink. with Joseph from SVB Schwartz next question

Your now line open. is

much. very Thanks

the have a But wanted trial. I talk being milligram it's for dose, dosing why study rationale understandable in dosing So was just higher study? you to ask about the the the etrasimod. wondering the dose one And studied in Crohn's to I if you'd lower could about

Yes.

with activity colitis I think the see dose did milligram ulcerative trial. we the one clinical in

it's doses. dose we we lower head to a think Phase a younger as support in I So may multiple II And populations. study need into important eventually,

time. age atopic with having there lowered having important be distribution, different a over may us just derm So

we're for For looking across study, else? UC to And study, of qualitative this We study. the that quantitative looking atopic adult just that dose Chris, atopic response. initial saw moderate the we'll severe be derm something in and in measure, similar for consistency derm. anything course, and we're, in every being

all the No, effective. derma the milligram other going for think looking authorities two understand, future effective milligrams dose that thing reasons for are regulatory particularly know, and that patient the place go for response. would us an And atopic important is the the exactly believe think is mentioned right. we the younger a we as into where quite Amit you studies. with about dose. one a higher as I that we and populations again, and to to And FDA most dose don't be We're as minimally for

spread of in as That like geographies. seems And far sense. there's it Okay. been different makes patterns goes, COVID really some then as disparate

clinical been given your if evaluating So possibility haven't just open been up to the in that hard as evolve? be and you've wondering it I all and of was trial as as essentially zagging areas zigging sites flexible plans. things more

Yes.

We number have a Because we worked XX XXX haven't made essentially out in how but it's any changes, sites, XX and with countries. anyway UC approaching for and us. XX, sites that's broad of approaching

And of so beginning the did shut pandemic. the not and things uniformly at turn way it's the worked for on side-by-side us, basis. We we the a country-by-country, COVID really off trial down

online sustaining really, So in of line. terms well we that really online, study. And out worked in as came momentum and in back us sites first back countries for continuing came that's were

simply a broad-ranging as think rolling color? just a mentioned, in a trial. the to it's opposed had Chris, as lights like out we any sort turning it exactly sense to off So blackout entirely. of because additional you clinical of worked We as

with our and And that are each we sort and understand connecting to able site week get capabilities a states critical. are week have XX the really, that's sure good Most really that visits. ensuring and making now we relative That's of we're practice to of of XX right. their to visit, kind every just

more really else. just so again And a site-to-site at anything handling level than

Thank you.

Gerberry of with next Bank America. comes Our from question Jason

is line now open. Your

the II/III. provide you afternoon. Crohn's. Phase on for Jason. is update on This on design have good questions for the trial It hi, looks Oh, I some like Chi some

like after first guess understanding for my looks the grow planning It is between the why one II endpoint programs? your the I faced couple endoscopic between you're have a chronic is Phase between there's Phase primary Curious the the score primary And will So endpoint III, score, score. that the endoscopic I and difference follow-ups thoughts of so Phase a then XX the score ongoing II. two the that.

Phase of that. for three level III guidance of I there's I mean III can registration programs, type for Phase obviously, endpoint. in regulatory what's necessary terms

CDAI to and rigor endoscopy of primary. co that of level Phase is having co-primary expected terms in II the the we have CDAI. need So and of of the In study, SES don't CD

to as I'm scores all wanted as those So secondary of sub the being terms tool at we endoscopy CDAI, in focus are frequency, components. the most objective. looking on important abdominal pain

have And so going all that we that from really makings the on III analyze Phase things portion the which is a of finding, going into dose measurement, But a on making of the we're data. objective wanted being the most we'll handle protocol able to to decision to based focus endoscopy. how

and Yes. that like also some other They quantitative more gone and dealt patient-reported if head on at SXP is have actually point they look up at bring looked I'll into an looked and outcomes important complications. modulators, only, have endpoints Crohn's. they've at historically that's flipped you endoscopy not

stringent II very we yield dose-finding analysis. quantitative to approach because a need taking a the So does here think Phase that directional we're

is curious at Got of analysis will as your II, get secondary can if ahead Phase of well the it. that part a we CDI Phase for And look III?

course. of Yes,

That's correct. Yes and yes.

other guess I other the are that talked or at the you endpoints. Okay. had only programs some of looking one about

part going your not programs to guess look at other endpoints? the second regulatory the And to the is, I hurdle, with some question guess issues you potentially the curious, my the does of it use of it strategy more be but flip to I one regulatory make side I'm endpoints? if There of things, meet stringent. challenging competitive compounder do questions. So programs, more only both that two choose on

Yes.

I think probably talking consultation the with than with in regulatory not different their fees. authorities. regulatory to regulatory our is authorities, much We're consultation same

for And what Crohn's always just and saying to are the years So that shortcuts. important to agencies and to getting I've we're on I'm sure We the said, I is, in the the guys disease. feedback is me want this working high four here speculate they're them companies are that take don't here. other have now, to heard there bar you And know going stringent. road say no are

regulator, just someone the end stand to attempt on in time the super a from to and a a a physicians, has to market full-body important. agencies. scrutiny, across in the that's doing doesn't bit supportive the every got work groups work. it you from is the the launch are payers, programs, And day, we regulatory data support a product perspective, that's pull going agencies They're of to we've to perspective, And So make objective to of our across think important not objective the But the all is but the The the eventually isn't the of way push work hand, just sure to little the advocacy successfully shortcuts. just satisfy evidence of shortcut through, thing. can up the doing the a the at patient board. is not

board. programs of the across So view we clinical more holistic a much take our

last program, one you are conduct Phase co-primary a use on endpoint from will ongoing maintenance for because II/III study? a to able you pursuing studies a as your top Maybe Or would have you of follow-up the separate that two to Phase it. Got be pivotal? II induction me is

Let it? Chris handle

so it's question. Yes, good a

as powered a So could analysis and The to potential III. such move to that phase data it's the that. can into co-primary were a standpoint, response with if a issue be we serve We're that going looking Phase II positive is from the conducted definitively it rigor those pivotal. dose-finding for not is do

the that we if strong, see be pivotal. is because that now part So think they if of that could the considered quite

the of time. So just of the kind the veracity data depends at on it

you. Thank

comes question Securities. Jim Wells Our Birchenough next with Fargo from

now line open. is Your

It's Yes, Nick for Jim afternoon. this hello. for

on Phase could The question for to that III? And used primary First olorinab. score. support be the pain a trial a registration product Is endpoint validated II in is system? this Phase it scoring

Yes.

we about program, exploratory the trials. the open-label First you I'll and a for Phase incredibly study, was think study excited III thank unmet the provide of here, II Phase tremendous cats about olorinab. medical small right there's need. and all We're all, The asking

to average We to decision designed time talk go want I was make a to trial. to multiple any Phase a validated So use score the a the pain did scale, in endpoint. instrument. no-go about It been really other approvals. AAPS agents instrument is The us area IIIb. It's for the abdominal XX-point used that IBS validated that's in caveat to move we facilitate

from does we'll endpoint. our IIb It So to there's into read-through Phase Phase II Phase validated study. a from III our read-through

that IBS-D for Great. those and analysis of patient And IBS-C of allow between terms then patients? to is enrollment, certain in balance

empowered for is analysis. study separate The

will So data move out color those the two over be major toward at patients. read getting data initial groups on between of time line we will providing as be subsets medical a different additional pool there top meetings the

tid a controlled Okay. formulation? release given product minimal And then dosing, is this to a

might again we viable It asked in lot is of the frequent of We program. setting, be. dosing pain tid before less we terms did is moved the should in forward to of we the And And dosing. less frequency is, much work commercially out important. with a

So or a more you very and over-the-counter if versus analogs, at more pain, you qid ask think you'll is ibuprofen see just proximate like sold ibuprofen simple it's once-a-day than sold for naproxen. is about yourself

to get that so XR of support an broadly. us right more eventually less in the frequent But be important. a It a less really the dosing. it's And pain to little that doesn't now, of and market out it CR saying, formulation, turns does probably less resource would

of be have II the internally. those we'll conversations the will back on data, So Phase

you. Thank

with comes Our next question from Song Roger Jefferies.

open. now is line Your

have one. I questions, Maybe question. maybe Thank you for two taking the just

adding is question first AD. for The one additional

and showing them you readouts some of measure curious moving a I'm benefit. from the kind this of just interesting, JAK anti some kind of saw couple pivotal are very IgE of inhibitor forward. endpoint data we So what

magnetically, you pathophysiology? Additionally, can kind kind that do believe model of how a address trial of

Yes.

hand to Chris. So me off let

itch But what's or at the pruritus not perspective. of happening endpoint is part registration. It's patient mean, for is I clinical very the of a important super understanding level, atopic from part derm it's important. important

standpoint, that and dendritic play then in going that we access the look data Obviously, to a impact come from trials entire see carefully. we'll through and that And so the looking look later are And be at you believe they mechanistic they at to here also on quite cells could TX we're do into something the the going year. what be like nicely that. when data when

just I for it. Got Phase clarify, will the that endpoint you have II?

Part the endpoint. second of Yes.

Awesome. Great.

Another question, but I clarify. mentioned of kind I think, I a just bit, to mean, you little want

terms release to you clinical the the order the in formulation, study? get to in So elaborate can steps on of control just operational first

absolutely. Yes,

So formulation, experiments, one looking already you be next move of a and know, at dose set and as PK/PD, to is formulation. clinical multiple dose solid we've exploring the step we'll to solid conducted

additional we solid first step, now before, which dependent, in study, move To dose second is mentioned we the be what do to the see validate work. I we'll formulation. able that COVID-XX can the As into what clinical some

So directly III work as need a can to we lot of the indications as the derm have bridge into work we the the bridging then assuming right successful. Phase do and now to that, And are EoE side. we programs, CMC on soon begin

work gets us has And done it's then and to some front then work heavy clinical really there. side that on the early get that bridging finally CMC end. on So some lifting the

as both human you bridging get animal as well And tox all just go done, II back the budget. So a programs. don't is have and in that replicate plan has that to the the an perspective it's to work in a from perspective. from of Phase and It's

Trucchio H.C. next you. Patrick with question our Thank from Wainwright. comes And

open. Your line is now

in have good Thanks, follow-up atopic derm. etrasimod I afternoon. on a

other it So meeting then is do and II soon on pediatric group outcome, the a And an you forward FDA? could end in both move with versus there hold your initially? timing? reason first, would from have could patient the an this And COVID-XX how secondly, Or some program pivotal following potential expectation the include pandemic the advise of we Phase start? adult is that the impact one you patients

and the So pivotal II, handle let Chris the me talk Phase then about program. can

We haven't disclosed pivotal the program. on a lot of details

the a II, the be as End to is rest the cautious we we'll move want as there. internal Phase company. So agency. fast can then of up to we And humanly bit move to

meetings substantial C in seen regulatory Type the haven't agency. delays to getting We with

no pre that would So this believe it as the at there's COVID to different in reason be environment. environment COVID the point any to opposed

a we Phase the of really data, got can, we've as want as already of prep quickly Do do you on talk back II about COVID? move can II we possible, the of teams We quickly so as So the ahead on work of data. Phase working. the back to the lot

the much plans disclosed As for mentioned, Amit trial. about that we haven't overall pivotal

you from adults. products, the and us adolescents, at older ages looking competitive As XX as so know, often as they're to well

So to have something consider. we'll that's

We have influence the regulatory program. how UC with populations. an the will overall pediatric interaction plan think that agency that we're about patient And other kind we moving forward with of

those making data readout of be we'll IIb year. out So the this later we Phase as come decisions

then histologic see on move in move enable in need That's FDA How how et EoE. this can And comment there And and forward? make wondering would you on study the to could what that be could happen And would is answer discuss then EoE impacting outcome expected then cetera? guidance looking or it just response, the including this etrasimod design you ahead the in the to that issued follow-up assessments if questions not if of is finally, would with clinical can Or study? the what and you situation, preference XXXX, well, on what you helpful. it COVID-XX first, to trial that I'm a just you time? trial?

Okay.

off me to Chris that. So go let to through hand

problem. no Yes, Sure.

about And take study willing during particular, thing. call, of site health to type on Amit about a impact related In on new nothing terms earlier this problem. time, of It's to COVID-XX, a what are in that initiating the really starting systems, studies. that's it's about the issue EoE, study, there's level is IRBs mentioned which a in all

as proceeding we're So planned.

far, it's just have dependent their clinic reception So hospitals on healthcare has the interested, and research quite systems really strong the during been but new actual on site ability already pandemic. and epidemic, to on take and

the lot guess, terms in question, that the a would guidance interesting Because second lack in I there's of guidance, alignment competitive really some FDA through. of, done it's among The and FDA the EoE and of by I been terms that of in question say, that's we've a of work being products other working experts document.

So our give we our enter into make very able close Phase to end II III. get moving II into to going programs to have then successful us that on design us of meeting be will discussions studies with their information, Phase the and sure to that a FDA adequate feedback the all be Phase across to programs of allow to are

thinking studies are just And to we company that types that prior that ensure commencing isn't their that of alignment so a in documents sometimes reflected to previous of those we with we guidance that's of the FDA the released the we split current in philosophy are so but years. sure interact in make with

right So becoming pretty is something diagnosed. more routinely dynamic disease that's well, now even a routinely, now intense not the EoE in becoming interest situation that because is just the really is of commonly but

I'm sorry, then question. So that your area. blanking it's And third the a of third development part question, dynamic on I'm very

study? the Just in terms to questions you of in what answer looking could be

Yes.

two be components. looking, main of at obviously, So kind we'll

to relative symptoms. biopsies we one is the impact kinds to So from data and to the get of that be other understand within going well tissues as that patient going important be things of of in are patient to as symptoms etrasimod terms is eosinophilic reduction the

focusing kind broad two be areas we'll So it's those that of on.

themselves eosinophils not maybe We most important the are have that belief a thing. in

So right we'll other us down thing pharmacodynamic to relative particular disease. pretty this And critical some looking mechanism give we're to sense measurements, and a the give insight and done and the to into of use that but including to that data things, of some good etrasimod's a cell type broad work of animal there. going and path action types at array cytokines that trial be here obviously, us kind of we've

I'd no further closing at remarks. I'm to you. speakers time. turn to back the And Thank this any showing like the queue the for in call questions

everyone, Great. today. for joining Thank you. us Thanks,

this and really Arena difficult the these progress, continue on II entire the see, we data focused atopic times. our remain to tremendous you consistently of during in COVID-XX, to on to as In the abdominal thank As we take like strong other derm moment forward a milestones. investors olorinab maintain updating maintaining key for spend. progressing as team provide here the you We, highest lines early can impacts in companies, the data potential new momentum support we'll highly are year. in managing year for and while are for at we our and integrity to work all monitoring to with clinical and look time pain our and I'd the for execute of programs, We to key QX just Phase execution, and updates on ongoing the levels. And IBS analysts line top look associated etrasimod importantly, in needed. forward trial all the

So our safe next to look Thank everyone conversation. care and with stay that, forward and you. take

your Ladies and gentlemen, on does thank you participation and program today's now disconnect. for conference. conclude may you This your