Arena Pharmaceuticals (ARNA) 27 Feb 202019 Q4 Earnings call transcript

Good day, everyone. And welcome to the Arena Pharmaceuticals’ Financial Results and Corporate Update Conference Call. This call is being recorded. At this time, all participants are in a listen-only mode.

Following the prepared remarks, we will conduct a question-and-answer session. at for provided up to be questions. for will that you time queue Instructions

turn over the Chief now will I call of Please Financial to Arena. go ahead. Officer Lind, Kevin

afternoon. Good

everyone that of begin, programs, and that statements involve like and products not and statements strategy, candidates plan, including our operations facts. licensees our uncertainties, we other regulatory expectations, Before to beliefs, risks we’ll forward-looking focus, collaborators statements historical I'd and make are that objectives, goals, those about and remind activities, R&D

statements made project, studies, related and SEC the S. can in timing to patient with These are of which including in the and and for clinical risks recruitment on U. uncertainties our is Web of the preclinical risks trials, site the Securities context Commission, found which discussed and the at as Exchange that results, www.sec.gov clinical competitive challenging clinical commercialization, and are longer be and study include collaboration other filings and and allocation of take preclinical timing or and sufficient and of and expected use may available and than which our regulatory for activities and amount further the outcomes results approval may and decisions, interactions development, projected and such or we not resources. of regulatory financial timing licensing be

Our actual results may differ materially from our forward looking statements.

like I'd Amit. call turn to to Now, over the

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In agreed Officer. our lead that as Arena and excited Inc. President Chief Neuroscience, Executive Kevin context, to its that subsidiary, Lind incredibly has I'm

this as advance all of to as positioned thank for Kevin, Kevin’s been of taking know, take like Arena CFO As have challenging served His integral has this you the personally skills Neuroscience. of opportunity both believe EVP Kevin at turnaround we an Neuroscience and role creative leadership solutions within and to for of in this Arena. his We future. the XXXX times has contribution will us Arena as June leveraging believe since unlock part well and the platform. uniquely value sits to I'd historical insights

treasury and build Vice executive emerging is as development investor XX Arena, to President to Halozyme Prior our Having us continue experience and in years several Executive and an is an CFO life and Laurie business, held to teams the finance, prudent exceptional Laurie scale companies, Laurie be and expertise, with leadership business management, including addition including Laurie positions team. the will Stelzer. significant leading while biopharmaceutical Joining markets. immunology Amgen. Amgen’s confident relations, of we management financial brings her Laurie our as I'm with in accomplished being level with company, of original resources. her management science in and worked previously at in

to Laurie team. the thrilled welcome to are We Arena

that, Preston call pipeline. the turn provide to our to on more details and over With I'll Preston? updates

Thanks, Amit.

set moderately X of later XX most to XX UC We in program, UC plan two Global look severely Phase XX, trials, key Enrollment sharing Our colitis. program ELEVATE we which data XX UC on to with XXXX. is evaluating ELEVATE etrasimod milligram registrational two with ELEVATE to this is ulcerative the Phase in advanced UC subjects consists forward and X UC ELEVATE enrollment year. the begin in and in track active ELEVATE

profile developing UC. etrasimod’s to that We are in data in X favorable compared Gastroenterology. the data existing these announce recently trial highly published and journal, the OASIS Phase believe was pleased to other prestigious We support therapies

trial synergy to results XXXX portion the seamless pivotal Arena to CULTIVATE, a on the data to the from this seamless second transition X/X our Phase Phase realize data an an program, Earlier to dose the We're a Phase CULTIVATE with program focus GI into This disease. real X/X X and of into examine year, the seamless Turning Phase choosing the opportunity for those transition the portion make afford around of program Crohn's the program. a a operationally a time on initiated of catalyst publicly and decision release we of program. dose operationally now ranging consists the program still portion pivotal operational is progressing. enrollment X indication, to inherent mid-year as

causing heartburn esophagus. indication evaluate EOE food impaction in like characterized to by pain Our is in and lesions development that can the eosinophilic persistent condition chronic GI swallowing third lifelong in in inflammatory cyanosis esophagitis. etrasimod is esophagus difficulty chest lead the a to and erosive fibrosis,

for S., high physician for in demand ex-U. safe non-steroid therapy there's those and and S. patient effective need therapies Importantly, oral for are disease. the no this EOE a patients. most for limited and suboptimal available U. are approved There and

we We forward Phase allow X space initiate in updating status Phase streamlined later be Phase dose receiving progress. you believe to precedent expect we orphan to ranging trial enabling to this work. designation, drug X kicking which a our for look which program excited the of year, on recent this off could and compound Phase exists be the X X as development this We're

Moving to in etrasimod now dermatologic diseases.

clinical inflammatory currently novo We mediated. I areata. believe indications pathophysiologic will has etrasimod de and outcomes. point we progression in potential programs, both out etrasimod potential some are conditions atopic of to key the programs process disease that modify We the dermatitis has and these patient T-cell conditions disrupt pursuing reasons why immune-based in improve believe alopecia are to development symptoms Because that and dermatologic great are

and to systemic step dermatitis defective environment, is disease barrier CDX as start hyper step phenotype recruitment atopic in function Exposure skin T-cells, to then in via on inflammatory this characterizes AD with in skin of is with genes, with injury disease first cytokine skin allergic epidermis, antigen a tissue the the associated that traffics other is immunologic of include Let's drive presents the rhinitis. atopic and the product course a has interactions often The dendritic disease immune progression cells. and triggers, to each dermatitis. reactivity back allergen by then of but process. recognized susceptibility lymph positive and expression environmental between can responses. clinical nodes that inflammatory chronic and allergic which environmental pathologic and asthma CDX cutaneous impact traffic to the cells activate Etrasimod first

CDX Specifically, dendritic CDX antigen to of which reduced, resulting those cell activation is nodes reduces positive reduced the to cells. of T-cells, presentation and in lymph trafficking

X atopic by expression common downstream with target the so profile injury dermatitis IL other of reduced Activated way expression your we of and and are as of the to T-cell is cytokine reduced, lowered the cells reduced, reduced. reach X. and helper also trafficking that THX if Thus and immune is such directly associated site cells such is along recruitment note And tissue T-cells T with THX also eosinophils. as effector the that, cytokines,

preclinical etrasimod with in we for on in has etrasimod rationale the which are All this of and scientific also trial we assessments been atopic the documented to to ADVISE AD phase patients and sharing track Xb look with ongoing AD in and confident are milligram topical first later this year. X to testing among results response moderate in to placebo inadequate milligram We with compared etrasimod severe is forward clinical X these and steroids. dermatitis,

some follicles I a AA in two single alopecia causing attack social including CDX of there in clear a hair disorder activated dermatology for is disorder that causing are and loss chronic CDX hair. all sufficient population AA treatments anxiety common of patients. wellbeing, positive body, hair the and in destroying phobia, is affecting suboptimal majority a the depression. reduction major life will and or is no of psychosocial autoimmune our Current areas areata. turn one thousand to growing stress, and the to of quality now for and sense which per is program, alopecia second T-cells therapy in even

what double Reduction and SALT milligram trial blind initiate for evaluating T controlled most the with modulators. subjects higher. action as their XXX described CDX mechanism year, a of CDX of recognized be or by of randomized XX one the placebo T above, of hair once trial, CDX of a will X reduces etrasimod AA, a of trafficking we assessed severe SXP Now of of alopecia etrasimod daily aspects and alopecia I similar the proof to or scale with This concept moderate Phase CDX positive severity X is activation widely and cells follicles. in to will the areata w it in the score positive to the cells

the program with believe Phase FDA, allowing U. this patients trial approximately Canada. in data next plans detail translate program months. positive with We breakthrough and development We look forward of timelines S. to providing over from XX similar to development recent will few design in enroll the We designation and precedent. accelerated may an that X/X attractive study these into additional on initial terms

with regards look forward failure, now with the rest our olorinab, heart acute of year initiated the we are to finally in with up half and data targeting top X APDXXX, IBS cardiovascular to delivering FDA. pain. the asset, our and Finishing second designation been line from pipeline, Phase in we granted pleased And the fast-track progress have the have which is Xb of enrollment for Phase

Phase year, trial will be X expect this concept We proof followed that XXXX. of data by which Phase readout will X in later

review call the our turn to over to like I'd financial to results. Kevin Kevin? that, with And

will Thanks Pretson. this our results in earlier detailed week. I'll here, today brief year a and while our and are of financial full release results XXXX be our more in quarter press review which from discussed fourth filed XX-K, provide now

sale. the of estimated XXXX, totaled Everest, from million, For revenue fourth royalties quarter primarily milestone by $X offset future reduction BELVIQ of consisting million development revenues from $X of

per expenses and loss including million $X.XX terms was of share million Net G&A related quarter In share expenses a of QX, in on for or compensation. which million share-based totaled of development million was basis. million share-based to totaled comp. $XX.X per basic $XX.X costs, the $X $XX.X research non-cash $X.X

fourth of $XXX of from $XXX.X million result, terms in primarily of of the million United Income expenses of compensation. share-based a recorded $XX.X $XX share-based of research the totaled XXXX million result $XX.X XXXX. million, payment comp. $XXX.X non-cash the including costs, assets as quarter consisting was which expenses million, For deferred tax related that provision revenues the to and were year whole $XXX totaled utilizing G&A Therapeutics revenue development million, of million of were in upfront tax totaled

cash share per income and year Net common XXXX, million basic stock million for equivalents $X.X December on outstanding. billion approximately per were cash, of Arena a XX $XXX.X shares or and $XX.X investments, the basis. approximately was $X.XX At share was

in In quarter $XX burn of of the items million items. excluding increasing cash and guidance, one-time XXXX, million terms be in one-time we burn XXXX $XX excluding approximately anticipate quarter-by-quarter low there Preston. approximately of QX manufacturing, had scale We fourth the to towards after and enrollment online we by and and to trials as continue double-digits nonclinical up clinical a potential high single-digits NDA outlined clean ramp to bring as pharm additional

three to a I thank with running ecosystem supporting pointed like look privilege of including entire team phenomenally I been our It's and over the forward I'd Arena second years. time. experience a shareholders have and broader Arena the the the who out, Finally, past company, working playbook rewarding the had Amit to

patients, for forward, the and enthusiastic continue the shareholders. to community our value build about Going I'm Amit? opportunity to

Thanks Kevin.

to on delivering path to across the aspects company major the progress all across deliver medicines significant build all our a we world-class on remain continue we making we important deliverables as and focused company. patients, of As

ensures atopic including and emphasis Xb data of the important IBS pain. to and of track and in exciting XX in sharing in later we the UC derm Our in remain our AA studies, EOE for initiation on ELEVATE study beyond, look XXXX milestones the year the we olorinab for execution company, Phase and major upcoming delivering etrasimod all forward and that the on catalysts

Kevin opportunity to As and a I final leadership to note, his to Laurie Arena take continued family. want the thank the welcome for

excited will to turn on our operator Operator? more session. the to over begin couple of now on progress I call Over the Neuroscience. the next Arena the Q&A to we're quarters, share

[Operator question JMP Securities. of Instructions] from First comes Butler Jason

is line Your open.

Just think a of the focused how infrastructure the dermatologic about couple you think payer indications. derm? talk alopecia? just, how on Thanks. Can about commercial for you infrastructure can about on the would how then first you build talk briefly And and all, the landscape you commercial about you out

to make one third you're then path the we're of and we In work and select to them. we of kind really they're experts of then each working with the heading why selecting indications. in the and space model is of all And with actually biology to this, a commercial indications we down talking aspects in animal these on exquisite concentric your question think starts change really actually whole right and world part today, it select the goes we sure specific about the back following detail proceed slew how And about circles. build

a side, commercial infrastructure they the position indication Arena's company excited time extremely build, within over On commercialize. we're about dermatology, where look can GI, special like -- a to

of to tremendous We need to these isolation. there's in broad the competitive products that's think we provides Arena range indications landscape increasingly advantage indication actually and in products. in positive, become competitive these of to getting the think Payers single lots give indications. real are know difficult will patients about the And a areas to we it's and multiple a reimburse going strategic lots with landscape, compared access for a When routinely payer unmet fact that access drugs. think products payer and across payer a about

that's be think really critical. we to So going

on. As example, we're that's the in you've broad indication And the plays having care in for advantages that substantial we very anti-CMS access. pushing seen range of think strategy role again the space, to a a one getting of

on And to their let my helpful. and congratulations very new Okay, both me Thanks. add Kevin just Laurie roles.

comes of from Fitzgerald. Young question next Our Cantor Alethia

Your open. line is

for This is Ana on Alethia.

any separation you in And MS, of any work out is and area you stage neuro? there the neuroscience, flexibility gives Just what that or this SXP any just the of existing can disease at now strategic color leverage the as you. carving rationale then on in broadly if you that provide additional specifically behind kind wondering could that work a feel target history interest in given more in early

idea massive a on. a of let components. this The comment has company still a entity coming I'll is some actually on thoughts multiple company growing entire the we're and pretty off reset and of is have in take back One off So part into evolving me a and XXXX. this of add Kevin carving separate additional

Phase pursue better have to we're we going the and on to focus that seasoned X X all around we some neuroscience want if a team leadership it's way and these to with space compound. So no important ongoing, to products important programs have it Phase in create and focus that put the

So that's sort one. of point number

the capital will compounds, near allows these us financial a new set to win two time as number term why additional and spin is, even which them, the the wherewithal and then standalone progress potentially portfolio Arena this it to point be capital be progress as complete in into there Point a required eventually will neuroscience in enterprise. we out

So for it that incredible overtime, this secondary and these creates the that's really think focus on I company important. creating really that's flexibility of a tremendous But amount compounds. of to idea

fascinating. really It's

If was of very that you this around rewind we couple able had X early of a are perfect dissimilar come it we got were Phase clinical compounds to kind of is think in We've look the situation. there Phase one mid really similar underlying person reasons And out microglial of stage. that inflammation compounds X, and of an XXXX, that's I those. back build a got We've to to and three XXXX, and Arena Kevin this preclinical think or too doesn’t run is kind a enterprise. platform I late to

because pending simply space. detail expertise done going on the into to tell of in will as to MS, I shied of compounds. away landscape the have the There's lot not we're be of well on as MS indications a historically you these a we compounds get multiple the question, that competitive yet. MS the in space lot work from On of

anything Kevin pause add? to see and has additional if let me So

Amit think just at said well. I I say SXP, majority if in very space. are neuro you currently indications the look for you it the would vast

of the going And about SXP that focused excited as so an part on potential we're and of neuro. being

Our Credit next question of Auster comes Suisse. from Martin

open. Your line is

to X expected so and kind Martin. wanted these these on what you quickly a on curious in positive see you've would in of This on Phase And set X? to like etrasimod guys bar Phase result is move readouts would I'm if to IBS Thanks. derm. atopic endpoints frame Can back for and specific Thomas this year, a to I for pain primary then olorinab touch of need what the look half the trials? programs forward you

that always it's remember of end for efficacy, risk just lot everyone points the but benefit simple important to So as are well. the it's things bars the compounds of efficacy a focus not on

level So into in you take the of kind little I'll some have these product. that of top bit in then having convenience terms compounds work competitive to Preston provide of all overall things dive a into viable more so and the detail. together of can the place, commercially a

the Let start space. IBS me with olorinab in

As AAPS change. most you a scale, the know, one about have in point products placebo correction a on objected

from caveats the If all of we label, a saw point with open small the you our on change recall scale. study Xa Phase X.X AAPS exceeding

north well seen we're delta that that a situation. point placebo one adjusted of So you'd

to commercially north that's assuming viable out been a that placebo to so of a of that's and what call we that product. we profile, has a be study one IBS-C safety And and we D, have collection, and looking compound think across creates the the happens think work well can point that

are sense and a how will we markets to in one that or of have tremendous I house of other have the market All both category the these IBS D out developed IBS-C important have on point IBC-C enrolling evolve. and in research are a pain of the that the programs all we've programs other look patient. So good amount out done totality at being are we pain recall label and we thing. data, there,

So utility olorinab. to there's clinical also some broader

pause has the discuss olorinab then see anything add to So and let I'll on Preston me and atopic if derm. there

Yes, maybe two just quick points.

of from the categorical change which was met FDA way from by placebo us of and defines in it’s the corrected to looking clinical controlled even placebo though baseline, gives additional XXX% the pain patients eight XX% at at which results small that is reduction or baseline confidence X.X definition. addition that the that the was met with at again of not endpoint week score All but endpoint response, of least In lot a patients. off as

categorical have to result And be, majority today the the highly I you that from that our the it's we've unlikely that of what seen while to even small this, studies because so to for in it, us adulthood placebo and response see tends data, tell other in around don't the likely is placebo response of so is corrected can't really study, a placebo we XX% placebo XXX% due controlled we categorical kind to change given is that be encouraging. albeit

of And cases there then needed say very second a clear it's thing is patients is relief. this in desperate in just for that need unmet level pain desiring I'll and high space some with

and And in we of believed that tolerated and safe which product, something so there's attractive efficacy here. as a something think really is, terms it we can fully that there's long it's as demonstrate we here

question. So switching to the atopic gears derm

As patient There's biological devise a heterogeneity use and a area placebo for you an tend cross derm. example, than is atopic corrected lot this on the all populations we more IVD. say trial on compounds, EC just XX the deltas of and heterogeneity is pun I caution both There's know, of just be through where things oral to range broad than across no comparing think there's because of patient one intended heterogenic. more

landscape a day in we've can that, can product -- with a if think a the not make competitive safety with only a involves. that their think I'm to the for around. program you can black being tell with those that malignancy. of Note have dermatologists in expected data deliver we to deltas including And as that are said oral have the JAK I including trial are seeing, talk you get serious the SXP competing and market the head liabilities, difference we doing products not are substantial other seen that we normally box dermatologists, market as the for here atopic developed have inhibitors I'll the the range warnings of a my we're abilities I that Having we but sure think category. that Those output a so very some that existing once we're difficult deliver derm program profile, with we

think So efficacy competitive real Preston? we there's both safety. a and potential here, in profile

Yes, add in for otezla, I the that the efficacy a response may example, is I'll well bar have the thing psoriasis think only know some does seen that biologic does just as to efficacy be of it’s compared biologics. not highlight We oral for the well to different. again an by and quite

that's still very compound. a viable So

in anecdotal results get evidence degree there. very can of excited the our that in positive do to us high run programs in preclinical of of that in manifestations with litany and terms of this gives physiology the how which evidence atopic And mechanism We're initiated giving program, we direct qualitative confidence state. see aligns atopic we other through of us examples clinical and in skin a have disease pyoderma the drug dermatitis, we've gangrenosum of while of past not related are so the all some waste UC dermatitis that what confidence a in a clinical what action and in we'll up through of about path directionally of etrasimod, indirect

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

open. Your line is

for This Kennen. on [Kim] is

both congrats add like and on to First, appointments. Kevin to the Laurie I’d new

question now you the us first is how top be are outcome etrasimod and OASIS you team the are North or line interesting and beyond our has potential help a trial due risk a So understand trial? as about top-line that on the True of team X thinking trial, failure? you focused can the which within year We'd this what also to success the

challenges the Score look the is end the ozanimod abstracts, And with three-domain Phase the that at it never onto Mayo of everybody FDA-defined zero. into rectal point Touchstone re-analysis subsequent posters, think if know, seen is cetera, we've data et trial. you aware the endpoint in north is as that One of bleeding X and and the you I as study true publications, for and

of have Phase one X. that don't is that’s So their X from to answering difficult Phase clarity the things we in question very

Now three-domain XX shown delta, at smaller three-domain don't we've shown Mayo Score. the in Phase remission Mayo of companies the We’ve point week get data patients the XX that, XX% actually pass a Score. on like with XX,

So in terms read absolute read the our from through, think to understand is what's got and of effect X that know I question clarity, the X, Phase you etrasimod we've out, through we the us size, to that's Phase we better place quantitative our there data company. inside be really our great get and more for better and look a a the as

say. to from well again, a Coming True three-domains, back overpowered. very to seen if run But assumptions. and is any the versus four-domain North, variables difficult there's study the math study, were powering you couple It's so their understand of you this we've that key not to outside I'd of the perspective, see three-domain powered,

in of so three-domain. to you And they small know very a detect difference power the have plenty

of post indicative analysis. that it the guess. just three-domain, they seen haven't seen we making might Again, that's what that have in think I but

know we looking to patients they again Secondarily, of that the received amount a are for effect who of create biologics more not patients size. naive disproportionate have

and are in patients We our study patients different. I XX% of where addressing think patient we those Phase to combination in robust essentially completely on in choose is population overtime, to size commercialize markets effect very effects a will very and size demonstrated key Integra, which anti--TNF from that and mind. keep X important on where So contemporary failed things robust know the two it we We're of four-domain a three-domain. very

in read I in we think through keep about that's mind the North future. as from important True really to anything think to the

clinical the our just are because I optimistic and where with simply this they to etrasimod so as Phase will and think read have they and their tell not drug more And X, from data. perform, through been as difficult Phase X concerned, we're are eyes far on we're that the close

our So atopic CDX atopic and several at CDX suggests Can some so like done least models and talk live derm of preclinical human. derm, in etrasimod accurately versus the some like the have is FITC data the around this ahead all for historical responses induced next of you may year? additions, your later knowledge question about at on derm preclinical replicate publications work atopic and the Thank you. that other you differences

that of similarities inflammatory variety are of lot I have across a we variety to based dermatitis focusing immunologic these And there related immune of aspects of responses. a different So that conducted models species, cycle a on described. look

So and have be terms sure, could ulcerative an response in but general be something not antigen, EOE an antigen. it for colitis, atopic that immune antigen, triggers dermatitis, environmental is auto it identical they're the could of in similarities they

talking CDX get In of presenting AD, this that cells. it's to GI cell we're through reads case positive a skin AD, and either introduction felt for the appropriate up the or activate UC picked for in respectively, that immune to by in where has example, of epithelial it nodes barrier T-cells. the antigen some breakdown T-cell, of form function, case an about the antigen and CDX, to lymph And tract presented the

the which are that skin the immune cell, initial propagate and dendritic continues then Langerhans are cells, the that also agent So skin to begins response. called

so have that to they traffic nodes. lymph and antigen And pick up to

lymph reduction these there trafficking these is node. very models examining the demonstrated preclinical directly dendritic to cell a the cells in in We've of that

So cells T-cells and antigen the there. means to we've in dendritic be of the activation node getting less That there's that that lymph directly. there's also demonstrated less not are because presented,

lymph the within from would where tissue is expression, SXP trafficking out piece generally. cytokine most less by back based. are injury to T-cell any lymph or that the the get mechanistic been the activation of I for lymph was of antigen SXP site it impacted tissue also tissue injury. the and dendritic That's again, modulators But the That's the by itself, all where origin well-documented, then been encountered, traffic node to might be of signaling. the aspect demonstrated it node cells, And say, activated, to to is likely component,

have which of don't There's a have facilitates epithelial to final is that think beneficially skin a to the level cell does good it cell thing. is and a endothelial do junction the And and hit as role subtype the this. SXP with tighter that's cell SXPX the example, junction, In at maintain an even signaling point and perspective. inside the cell widens that impact we cytokine addition, can and efficacy cell to level only hits on the lesions not junction a fact which in, good helps and receptor trafficking just thing to to beds, cell actually etrasimod at of or SXPX SXPX intracellular, safety cell cell to receptors the aspects cell endothelial or that at the cell and expression a kind opposite,

So Neuroscience. last about our question Arena is

suggesting with someone I with involved more scientific literature mixed involved traumatic at disease. in where the So brain assume SXP the, community Alzheimer's more some maybe etrasimod injury

indications? partitioning Thank of team any how the think those any directly plans newer target more you you. to So Do about this? have

will and in And property. specifically property about doing be specific get then Kevin process his organizations then preclinical market Yes, work a clinical that's needs where, to targets of We're comparable this portfolio to team. And there's underlying in out, showing platform space. commemorator compounds a us inflammation, And tremendous filed. amount an gives completed to intellectual and to broadly having discuss or really pointing neuroscience and animal it's needs early of GPCR you're compounds interest to the as call billion be both bit in future of so as get and public, we're and to information up at for billion we'll $X and indications. really come with the looking in intellectual a sharing forward well that cap as talk us already to we'll future place you exciting us. Clinical earnings on companies critical piece And of piece building are for up a a point you that and back space time. the that's $X in

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

open. line is Your

This Amit, space. for pretty is or questions. on our Jason. and Preston is [Xi] first for guess one in maybe maybe really well I the doing Thanks for it taking UC

trafficking. follow that. of Entyvio? to Just has with of after I couple cell have that and SXP pretreated curious important patients up thought efficacy you it and some demonstrate Thanks. think and functioning How overlapping of on Integran immune your etrasimod is in And given sort a

of those have some Phase we our in patients study. X So

as not in both and Entyvio did in effect see bleeding, early rectal we and stool an is with frequency, two act, X demonstrated in Phase Entyvio. our are as we've We publicly, excluding to slow weeks. separation pretreated Entyvio understand pretreated indications said always who are patients important It's very to

cell this as about, etrasimod T-cell and So just migration, have seem activity talked cell dendetric simply T-cell just activity to cell to not junction, story. is does beyond a Preston

that's think So I remember. important to

diseases The derm overlaps organ-based landscape an all disease training remember second about that atopic in because when but alopecia think with important derm of have areata, tremendous to overlaps ulcerative is medical these is Atopic autoimmune in these training you compartments, colitis. our overlap. with part

you with about manifestations manifestations. address the conditions with specific actually organ are talking systemic autoimmune primary systemic are and what biology so And are some really gut shared that drugs can't

important that's think likely I patients heck and of also manifestations not IBD lot. of So have remember, sort intestinal do extra of to a is antabio a XX%

So Preston, you want to add? anything

No.

covered you've think it. I

U. been potential X, right Phase a -- looks XX% translated guess Phase think have look Entyvio like like versus to X now of roughly is efficacy going in about sort I So market different X? that is Phase to in the maybe baseline, I And X how Entyvio enrollment is or Integra. when sounds both XX% at think right share Entyvio on now. or the about they’ve just take maybe any sort give be S. of Phase mix the of or going a of the plus I or TNF effect This is to

have you completely think I that misunderstood. Yes,

market the products. getting XX% trials. with share, patients into treated share of share So who so are market are percentage is Market patients of and certain don't patient opportunities with confuse what

You would to market share not steroids. compare

have in IBD. XX% market steroids say You'd share

patients the is out to at erroneous. and how are of look underlying fit rates What between share figure actual the market what baseline using really So percentage for they completely biologic need clinical and untreated. to treated you is trials

Entyvio, the patients all approximately look what research you those in if could the That share with States that say at we the that is good have, see epidemiology number. XX% of with have extensive of you, at actually you are important with you'll not never And flows. of you the treated in XX% biologic. of treated been gives a market and that all look severe moderate remission, to United XX% group more that's are small very that's biologics, a a that sense been you how really that And that's on metric. the And

some remission. those or in XX% So not of percentage are and XX%

criteria that's a So to apply inclusion way erroneous better a that to number, apply probably actually across works. not it how it's market full share that much that's

is And this Preston, just I'll follow up.

of likely take X, really prior of about Phase Phase our background least failure what part your failure versus in say Entyvio pretty failures, another the question X history just think different X of confidence proportions And that to terms of in at concerned to coming to respect not what amount a for from we of is for types fact of naive. study. the around example, be think was of terms Phase our into similar terms biologic to we TNF good therapy see are what I'd I expectations biologic And I example. X versus in with our or we're compared biologic in Phase therapy,

X exposure. in biologic of we trial, XX% with Phase had patients So our prior OASIS

see not had to right actually XX% with terms severe And seen market naive, line have seen patients what with not the prior XX% innate just disease, them of So in Amit the of biologic. see you biologic. that's a said you and today or moderate not in a

large in anticipate Phase would Phase programs, X. biologic for what lower they to to expect compared X difference And market. Phase things in because reflect other to Phase be Phase we've I X, don't accurately would tends we them always had much already a of terms more that in so the a X, in different exposure And say experienced if you X

from market market actually share when how not the again at share, summarize marketplace. is XX% saying by of patient the the the cautious about So entirety the share, we’re extremely which we’re breaks just lead relative relative market talk to making out, that's segment, not because I'll inclusion, to people now to biologic its market

gap can the from Phase that to you X analysis Phase might about that data. help, going follow un-blinding. through the induction not one a the Xb weeks not walk data time affect from us to transition last on X us data elaborate the un-blinding or can need question the analyze may be the you to or might or the or X Maybe XX potentially And process? talking to Phase through, the patients you going Crohn's. there’s how you you and straight Phase from and that maybe the to trials? Thanks. would if in maybe through patients of you Can me time from There's Xb, Phase walk maintenance it may Are to seamless okay, transition

misunderstanding the you're think I of concept seamless.

Let me ask Preston talk about that.

versus we're operational seamless. what things intrinsic So about talking is

program usually on would not part patients and as would enabled we publish catalyst X an If X, which people think want access, our doing by we're decisions to not we be forward. is committee data, us independent information. pivotal intrinsic that we're not mean actually a that Phase we the electing and have then conserve Phase that that see to for decision we is have nice don't seamless access dose in to by because made in actually Phase the that, And those own make XXXX. in of And do move were to data, the Xb do also what often a typically So sponsors to X for that. -- Phase example,

patients amount dose -- amount What locked patient and into we meaning we is dose that the make that the into program, data, required the are a dose. switch rapidly program to the are keep do decision we of while then such while by have can with decision, flip that's are so enrolled make the will X of the appropriate this Phase the enrolling locking we patients of we data

this is going happen we our mean, -- seeing we I to for clearly get we'll the X portion. more as to Phase lock as closer database And so talk

a it to closer will publicly about active, keep Phase an to because get to sites enrolling. so of up premise stages and S-shaped we're And doing just now them off, beginning the this. exactly disclose so we the sites staying as get is, there's get Crohn's shut don't how stay up X hot, that disease more curve, in to that, But like machinery ramp activated, We we're speak, at be would we always period running. entire

more so plans forward. talk will we And those we'll move as about I be --

with Our Jessica Fye Morgan. JP next comes question from

open. line is Your

in adults what relates in it dermatologists to of derm, to want atopic they terms in the see that bar and has the setting? safety pediatric you in to setting, for expressed As both in adolescent

definitely market what the market IBD. Let by is researchers we've over. me than What for in a the advisory seen atopic boards. in are research. the in has is safety the participant cautious more I'll call just do bar play of then on for lot Dermatologists across is the board. Preston we comment see derm in play been it hand and higher

dermatologists little of IBD barrier for it a bigger is for a big patients. than The monitoring dose first component is

when put the tends the the JAK to profile etrasimod that you of inhibitors, better. much context do in However,

if for time So they monitor it you wait more to of patients. idea the JAK all the to a more tend and derm office have and the side hours well to go, other atopic to put they’ve stuff be do inhibitors to acclimate JAKs if of and and in and to against then by of this terms sort having side for the couple you it JAKs receptive you put tend a of minute, responses, don't set had of in etrasimod you certain standalone intellectually profile in side-by-side then look oh,

a case kind market So scenario we in of present again, worse research. the that's that

moniker right actually inhibitors couple for to of hour be describe looks huge and turn describe in the you vitals then in Having it a context and the out when better. of it a JAK and patient in chair you sit the way doesn't hurdle the

make a that's So research perspective. you market Do there? want to some from comment

as in that, know is to just comment topic we with SXP monitoring mentioned, say to modulators. you terms of which Yes, a first dose,

that's data signaled this they before. FDA each of about We’re encouraged and a are an why see would not has that have they not terms you encouraged first majority monitoring. have need that the dose example, as monitoring greater don't in cardiac has to siponimod, does long face conditions individual the that shown, compound at class clearly that its value pre-existing for that take the of for as that label as patients label We're lead it’s and we a talked

obviously other to the And the a have there’s cetera. development modulators the we're to et heart program direction etrasimod lowest so SXP of to Phase the that's programs that there all it potential and because lower rate not has this data, because does siponimod address led know the potential. delay. in titrate lot to And first compounds in designing ozanimod, the our that to out AD we’re out fact etrasimod need in and dose we in type up delay that what to intrinsic X has of cause we know X not And and that ability or conduction Phase and

that working our make reflects and are label compound to our difference sure known not we and So translate labeling. that class

in are doing And trials? confirm, by to establishing you your monitoring first clinical that dose

setting to in collect be needed our of and you trials doing would that. dose all to then the a demonstrating but why show data first in we're to be that setting, marketplace able the Yes, have monitoring not and commercial

you etrasimod And we underlying And through from including relates that to the biomarkers kind the of type biomarker settings? if information that immune in other any settings, could of GI efficacy read to as what cells? the to expect it planning study in update any later Are on question year. to measure the of effect on atopic derm this Phase second related X learn

looking There are you looking else? histology, about at specific tissue things and for here. example, something biopsies Are or you're at thinking

exactly. Yes,

biopsies Okay, … and tissue histology

in cetera. obviously a a that overall grades in do to analyses that to this, Phase program. UC bit you to of We'll, of of terms intending that subset done our the do take look at development, a more you we'll in et we've in have when tend and plan X We

disease we answer say and -- the yes, So have there's best. pathophysiology not the of for biomarkers the still at don't is specifically, this clear around necessarily, a would there's are molding -- which short but I lot understanding

take as Let's an specifically example. EOV

T-cells, thought a on great. refractory Well, it. GERD eventually way PPIs to cells. scoped. there's that's were people eosinophils, had on dendritic pathologists tend lot focus there patients eosinophils. T-cells, also -- there's do histology, the But that’s of that, why Why, to who to the And MAT respond because who -- of that's the that's is positive CDX the got is have the CDX, name cells, in didn't But because

causing is the cell eosinophils. the addition just the damage. so whole isn't to there in eosinophils view are And that a It

And the leading understanding still, that's us particularly I EOE, so is are biomarkers the at best look what information would field. to to evolving say, for an

comes SVB Joseph question Our next of Leerink. from Schwartz

Your line is open.

well. Thanks very much, and congratulations on the all progress as

in sure make X, ensure data? are UC you that went order as network to First know just of to as program. kinds Phase well of the in to but execution all, if enrollment that on I order you're and your high was possible in real --- any is time that experience the what smooth as the Phase updates, produces and rapid qualitatively X I entertaining not going be wondering doing given timely things quality

program? UC the specifically ongoing you talking about Are

of competitive in house. things exactly. and Yes, space, of Obviously do out what kinds you the wondering just and

very clear and competitive Yes. it's space. are really UC Crohn’s

uncommon And et they cetera. have not six so months sponsors months, announce it's XX because delay,

pleased are are track. We on that we very

pointed we as And give weekly so don't out, you updates. again enrollment

and key will anticipate XX, for longer about to using year, to we both network or because XXX XX triggers prior do when to XX, enrollment that the XX. UC of to study. is complete same we this complete in factors that obviously people of or global get which the of kicking a XX majority UC at least start XXX want and talking One sites is key good we're We off clarity because enrollment later

be that indicator. about key talk but we'll will more So that overtime, a

endeavor cross the here's like of short of we're a are doing, answer. a We're where a trial the drug. It's launch treating functional of your customers. a of terms things types the launch In sites

to sure are teams, team Arena the and sure to listen staff, to We as individuals, asking that as to investigators both can that the and coordinators, relationship fluid owns make interacts things. that additional nurses have establishing physician with field interacts clinically PIs trained everything the that sponsor at study make another and with team and we we're we're them productive, much be site doing things them and do one

focusing Another factor is on referrals.

a UC XX% biologic. mentioned, Amit have with to As patients of not Crohn's severe or moderate -- seen IBD,

means a lot who that disease biologic. have So severe not a currently to patients on have moderate of

to do it, roster, we've hundred and a of of own miles their course draw they but patients from limited. advertising Maybe generally those sites. some clinic If typically that enrolled patients in of -- sites, say, Because do often used you trial go is study, are our what they are and those why they that? that’s all they'll hey, sites done but about is

patient that about there clinics know that many being are concerned why are those patients elsewhere. physicians they related trial about not Well, these be sites And their study. may How sending don't are have not the to enrolling? and there patients, issues

additional deal forth with study, And raise let relationships so there's actually the awareness putting and clinics develop and teams we're that, people know, ways go of to cetera. field et to with outlying that

I'll separate say two team actually whole host that of we cross a listed folks them. just functional together. We things there. have I have So a brings

lot also and development clinical about insights medical or just we not we clinical as operations, It's of involve a commercial affairs take well.

a doing this again, think history we have and endeavors. other way. be cross I to I'm about think We we say And team many on pleased the on creatively to of there’s people understand are and a able very pressure table that just in to this functional think in track. the

it then Thank addition of selecting you. maybe on Phase was to in like better key seems a the right success And kind Xa. pain perhaps to olorinab, in agent, one being

you have So pain pivot? etiology IBS to that done made comfortable get what when you pain is analogous I wondering, that IBD to was

macro you inflammatory to which as develop it daily and a then insult remove Pre-clinically S, quiescent the essentially we was sensitive Crohn’s. specifically in down didn't hypersensitive did disease proof not for they have die had basically we introduce Xa a wait of of insult Their were an an colon, take Phase you're Crohn’s, trial, so model with the had active inflammatory took of and you left our colon. quiet concept lot specifically is they're abdominal colon. inflammation. hypersensitive the way the IBD and animal They pain, initiate yet acute flare inflammation hyper And to and I they

have that so we the in way kind nerve about need of IBS did firing, what sensory that of And at out receptor important to tissue that to us it another up the receptors models addition the exist and develop there’s and is making CBX lots IBS aspect this is IBS, in what the And the there. that the fact helpful is apheric think with confidence preclinical, know CBX additional of terms of very leaves all the in are and which approach. fiber clear patients terms clinically you the of and space so to important in regulated up-regulating that in in we clear met IBD level of mix in the both animal inflammation I literature

enrollment clearly again, track. so on And is

with comes Beatty question Joel Citi. next from Our

Your line is open.

comparing put in context efficacy strong trial the any First one be are previously X the how ongoing Phase on the to Xb, previous Phase talk the you to ongoing Can or likely similarities trial? the into and olorinab. likely help design about results is differences replicated

Xa just of the a was which It daily is state. the difference was had the was patients the Yes, still that and different disease important Crohns’ most question proof topic of abdominal study in pain. who concept in so quiescent last

to really want be than IBS. clear just I is, that so that’s And

Now Crohns’ and inflammation development got in essentially, that in hypersensitive that fibers level up-regulation actually from I have and fire the plays some pathophysiology it receptor and colon IBS just IBS system know the the of documented you've role is when the the that pain of reasons of particularly that the reducing does why and between inflammation. gave tissue similar we we at a the all and quiescent state the think

XX X of which course week is So treatment the should those we Xb three the with a I'll doses, important design got it's caveats, difference the have only And say also that is of enabling. ranging we've all dose It's Phase be study overall period. is a so same. that full placebo, on and

implications pulled any from beyond amount Belviq Arena question, being the from of on for that? receiving market you've other small thoughts one royalty that the recently, And been any revenues

and the S. recognize of We to the with jurisdictions. had renegotiated S. we Belviq potential outside royalties. forward, So let value with me just take had the that the of is part, our see revenue lower rights when the value to the first ex-U. estimated royalty royalties to an IP and future the offset which sold in agreement certain and to U. of going had in our expecting in do We're to which we ESAI revenue QX, XXXX.

see their U. value zero are S. about outside forward like now which royalties. that Joel, reduced and we've what on going to we'll sales of look projected again… the sales talking So products and impact you the the

comes question Carr Alan next Company. of and Needham from Our

Your open. line is

guess, quite. almost I So not but done Belviq with

wanted assume the Arena burn hope can Phase you the extent critical you about accomplish from And in X with you I these clean? XXXX? But Neuroscience? term go ask is to for any strategy is Thanks. an what So then that's I Kevin, derived big and again to new long but program. of to XXX. X over your etrasimod, you on mostly entity Can us give what update Phase there assuming

the strategic on take XXX. broader me Let question

out this that there we clinical overtime. The stage sure do compound way make now is this some output address about cardiac begin incredible be this those out actually dynamics hypothesis we of about to is this these our that closing time, compounds just patient and strategies the the a the what to the virus that like at and the for And can in changing cardiovascular patients really improve did XXX, time, where to markets at strategy talked disease prove going the are addition need additional that, company and just, in etrasimod where then that at is rest to we've look was these let's we'll So we'll can of at relate lot without cornona that where's before, the capital unmet time, what once figure were have we right thinking that time. is. cardiovascular

happy design undisclosed talk make this little bit can X it of about there tell cardiovascular we're you we're many a lot outside control are want So talk sort detail to There's control that. portfolio point? our been ability there's choose to most you whether in continue about have a about program that at determined the to something to of in excited talk the it. you more the or and made we we've study some do Phase variables XXX the and whether creative public that -- will incredibly some develop about of that I that. specifically we specific so are that to Preston, extent our with programs the

say just what looking be clearly be for mechanistic I'll and Yes, we'd would information. that

measures, and output looking in in de-compensated of longer with failure development, X XX,XXX kinds a heart assessment at also based terms There often compensated so heart of not it I'll typically a XX,XXX programs, Phase it's that failure an necessarily. do studies endpoints would to go about assessment. those are And very over could say these ways outcomes are day not so So cardiac have outcome of pivotal patient that to or be variety years. this. XX

to the is unmet willing very appropriate FDA medical of tremendous discuss The in at and a space, lack time. this sit with sponsor need, the because of therapies the down

novel able great it why nice a a a setup such forward it's to completely be a beta as bring And story to MOA three so around antagonist, work. it's can

true with we have we're about to and X what to so point, And wanting up end potential Amit's we do how as see a excited it to we'll Phase understand its but we when evolves it trial. landscape conduct the

etrasimod. around our burn I later we Alan, is majority clinical the around things or as of or vast a the or which is Ks, and that think external around will of the the week, And our programs. see well. was disclosed will then, be be in vast you'll And anticipation going other etrasimod, this XX-K be these other filed had neuro spend preclinical not around case that of like majority forward. spends, in XXXX When It'll question that the CD you some the

ago manufacturing the manufacturing. pharm, we understand important think start around in agency Phase and tox, making corona about while being global with mind. manufacturing sure develop we X over thinking We’ll qualitative chain tox, substantial I and where Alan, indications early thinking supply about to the on it's issues long-term going be was and our a materials, in we backup had just year sites programs able stockpiled current larger starting to virus clean backup these requirements this move

NDA. between So and are give that you all they’ll the just see of now programs doesn't different required you that quick the an time really file smattering a

deficiency is when complete it's interesting, ever there's the a comes response up letter. there's And only time this a issue and

no lot a we're optimistic stance of taking make make the we to done to a the done. work about something We a want you quality gets a extremely There's on keep very the so get to what patient in etrasimod NDA in we So fashion, filing. done, under work move aggressive when sure compound. all sense of high qualitatively. there be that the the just gets that's in mind work gaps to we’re so it’s want on the sure out, sort And that critical, reads really to forward see is the are again don't water

Is double-digit low just million high you single-digit quarter. said that you meant? increase each to Kevin, what

increase It’s quarter. percentage per a

Percent quarter… increase per

same to translates Which amount… about the

really is enrollment so dependent, line. of lot direct that do remember a And just a of sort light, difficult to clear

better the good should the be thing. burn the the enrollment, that So and a faster

question Trucchio Our Patrick Berenberg of comes from next Capital.

open. is line Your

treatment the extended MD And patients, for we IBS-D that's trial if you X I us data move additional area then prescribed year? further significant or then the on payer Phase you is been positive the few see being you half olorinab, into what then And Could need in linaclotide separately, trials, that and X just top can a already which between can this there that you've or reimburse the the can for and necessary? secondly, difference for NSAIDs IBS-C mean XXXX, work and the regarding X second on first their medications piece, done with IBS-C release need unmet be payers work ups for a Just trials visceral or IBS-C or for inappropriate an And of the unmet used the directly extent just prescription frame in tell a that from would pivotal be outcome IBS-D? and finally D? typically are of additional to is various subtypes, us you and around the pain? this around treating what an And what being between elaborate or the benchmark would D? Phase Phase suggests opioids Thanks. upcoming follow

And and start of on the so and and landscape, D clinical United continuous me XXx all can between million patients independent pain IBS that's market XX on third the the at drug they’re XX% with and unmet let IBD the If C, of take size look just linaclotide. recurring in the of States the the of So landscape. third nominal question contrast, by third. IBS a we abdominal report extended need patients the of then the that's release and roughly mix and the on on payer formulation Preston changed and question

are So perspective. from really are IBS-C medium. D it's large very of counter And over between a the and the markets a patient bulk patients

on a they Over and pain the on a the diarrhea, counter do job cramps. or but good abdominal of abdominal really do and relief great the agents either the pain job constipation don't

around So this of just is management an ongoing conversation pain.

that's given a of pretty I imagine some pain, striking taking that In those number. dimension of that of payers. fact, The patients, the size opioids, opiates then is the will XX% for IBS-C just management think of pain consistently for the to talk on a and really of IBS a you traction. opioids patients confounding. focus which is nemesis can just use But of only described patients pain that market of are their long so about time gained absolutely lot and and And patient the these theme it's groups and of a that

These of a or top oncology pricing products diarrhea. products priced on using Naturally, or these of that patients for be adjunctive range the their price you would type they‘re constipation are pricing type of MX in products at aren't that products. broad are to existing

about... So that's kind wide about Do opportunity you a market talk And we space. to think how quickly of think really from it's we want it perspective. open

the into the and X both, So IBS study X plans first movement Phase was from what for IBS Phase question or IBD. are in the

current the is this IBS, Phase study for enabling. and clear pretty it's Phase X So X

ongoing we on look how at make appropriate make we agency with is that. dose data, we'll can execute make which basis, and discuss selection, an planning our the So the sure are go doing X Phase sure

that's plan there. So the

and necessarily I positive appropriate on it's to it's olorinab the when down see that IBD way know guess not would we'll about need relief. with go we setting, modifying, therapy call sit IBS, an adjunctive to are for because in pain in FDA this you results introduce Now as we or disease agree

require of space. will the some so in with a And this precedent that There's additional not conversation agency. history great

then Phase conversations Phase anticipate an then I take that's those X with inappropriate to trial have why we need agency. to X and some all so And time well. if conducting goes the to moving

then And and just other formulation extended I was appetite release on that work doing question think your they're the there. the and

that then and to the And true is need have effect. or call, publicly terms what but more linaclotide suggest was ability baseline obviously essentially to isolated that be compound with we'll to is But original know than agent that in the it’s modification placebo that difference of pain I linaclotide if used overall constipation. to addition broadly to in the controlled difference, not. X.X can We'll part understand point potentially IBS-C. we see hope itself the a its the well So Amit see as data see, X.X, that's in in mentioned motility, the related with from of was we'll as one need is the that that change to what earlier that placebo could that

that some have now. to without and an And kind small delta in consideration. our that’s it mentioned we mix. doing that effect. have me the in of hurdle earlier, in us. you the as We third we're and We have bar demonstrable placebo IBS-D at confident take there's to controlled can of olorinab -- that saw we're least plays that and placebo, we IBS-C, need use breakdown I this believe the so robust that agent leaves a of which the study, so mixed. X.X that controlled But And a effect, study, set just for can or to that we'll a very can But how out. across third, confirm and C, And third see population, that's a D about

the on segment, the we entire IBS. essentially go across focusing spectrum. in IBS of can aspect is And instead so unifying pain And one one

So lot that's needs the as aspect and counter often true, about one agents, people can Amit of unmet with it's you mentioned, really unifying motility over just so where a the pain talk is. that control and

the further Amit to back no I'd to any are turn remarks. like over questions. for closing Munshi call There

We've goes continue you. important We support. look as and us ahead us, a lot we of really of everyone. Thanks incredible to got the to forward Thank year Great. you Thanks on. for opportunities all today. your joining update appreciate everyone

conference. does today's this conclude gentlemen, and Ladies

day. great a have Everyone disconnect. now may You