Provention Bio (PRVB) 7 Nov 202020 Q3 Earnings call transcript

Good day, ladies and gentlemen, and welcome to your Provention Bio Third Quarter 2020 Earnings Conference Call [Operator Instructions]. At this time, it is my pleasure to turn the floor over to Mr. Andrew Drechsler, CFO. Sir, the floor is yours.

Thank you, operator, and thank you all for joining us on Provention Bio's third quarter financial results conference call.

the and team Co-Founder. from Chief Ashleigh call Officer Executive today's Provention is Bio Palmer, Joining

future. approval as in and including important of may differ factors, across preparation teplizumab Factors our our These for our same. by potential recently First, impact of indicated commercial our runway, today various and teplizumab plans, make a statements. XXXX make in the with BLA, our and forward-looking other those remarks me including statements use teplizumab XX-Q regulatory financial we our business those prospects, discussed statements the let Form is which studies other of and report remind including safety, in will on and today business you represent of filed file for matters section and these Actual and of the in SEC the company forward-looking the the constitute the result that materially for results, potential expectations, success statements clinical COVID-XX future product we results that timelines, cash activities and clinical on on potential of in the the timing projections, Risk with projected various planned include views development filings may as SEC quarterly Any the the and anticipated the about the only. of forward-looking quarter most pre-commercial including and from plans candidates, fourth our cash efficacy

specifically even uncertainties you these not Provention's at of our documents point to at subsequent so the the $X.XX There documents we views financial change. in our as update on to www.proventionbio.com, said, elect disclaim encourage our to available these if today. our we generated at We Investors that our section. financials. Provention financial the statements, was our regarding While condition. statements information XX-Q being these well forward-looking forward-looking analysis today. as rely of risk date more website risks allow statements our are includes for please do and some discussion of with quarter the per obligation SEC. as we as representing is any earnings encourage to With These filed factors XX-Q and complete review in I forward-looking Therefore, diluted should future, any and to reports views to loss and files you under the statements, net P&L basic you a share. million me third or that would press perspective, a $XX.X read management's provide carefully. From QX release also may

in prior Our million. costs, preparation increase cash-based the $XX.X net for year The CMC were costs, quarter to loss and attributable expenses costs, over the affairs PROTECT expenses. teplizumab study BLA medical precommercial related was third operating costs,

the a from with which clinical COVID, quarter. module in QX included the submission. X study pause resumed related costs analysis. The Enrollment primarily Phase As spent QX the process related activities related PROTECT batches qualification spend our disclosed $X.X R&D trial related resulted during in spend performance during increased to Also to clinical significant preparation and our we to million on activities. CMC was and costs XX-Q, other and in BLA in

and of spend market included Finally, and unbranded expenses as personnel also marketing as preparatory activities included pre-commercial $X costs. spend on QX million access well

or was XXXX first $XX net basic loss diluted Our of nine months million share. per and the $X.XX for

our second teplizumab months, in approval and CMC, study positive activities potential regulatory in particular, cash-based to million. to-date. driven focused timelines pre-commercial, the in the first was expenses XXXX Our quarters for our PROTECT $XX.X and operating by nine-months the manufacturing the progress for related were third September on and spend marketing US XXth, nine ended teplizumab and The was

in cash, ready the and continue XXth, and non-responsive year. balance of $XX of to operating Phase the million expect of in cash $XXX.X launch as scale which million the was equivalents newly we than and study XXXX, of potential in organization, Phase XXXX, our teplizumab use regulatory marketable to manufacturing study September cash slightly and TXD the celiac our our build continue commercial out conduct proactive million, securities patients $XX to in for approximately X Xb As PROTECT less preparation QX, key infrastructure for next current fourth activities, we needs disease, consistent diagnosed plans, quarter is with

other marketable current call in launch the that expect six-month review initial approval to teplizumab our developments. to execution We requirements FDA no sufficient be on and our of that securities significant the over cash, the a and priority assuming With potential teplizumab turn let update cash fund of an Ashleigh and will delays. for me operating equivalents to

Ashleigh?

today. and for us Thank all you you, thank joining Andy,

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Dr. Jenkins welcome and the to Directors. achieved milestones clinical Board to addition this In we honored our to of quarter, regulatory John were

of Center tremendous Director we the or as Dr. as the approval review Jenkins and insight Evaluation former through Drug regulatory Research new of and the office advance label drugs as potential expansion latter for stages at well of brings FDA's initiatives. the CDER, teplizumab As our

that our tirelessly gratitude deepest disease. to I Diabetes and with to Lastly improve the caregivers the of like Awareness immune-mediated increase out healthcare series to November to who would of National to the providers month. want living lives is and work TXD We people extend patients, awareness call

plan in be and and of process. first to work to continuing forward the of the the by a to launch remainder our We XXXX, the possibility driven with of continue transition potential TXD therapy of into regulatory for to organization anticipation ready we company commercialization disease next the the transform during bringing to FDA Throughout modifying teplizumab look market year.

teplizumab questions. help their fundamentally will candidates and pipeline other needs we associated to open now unmet opportunities up autoimmune caregivers. to addition patients And call diseases. with passionate therapeutic the our to address are with to advancing your our about In is rich we the both potential And serious take

Thomas our Leerink. Smith question first your from Please comes And Instructions] question. [Operator of state SVB

good all of for A quarter. guys, end. in and on questions Thanks morning. the Hey the taking congrats questions progress the on my couple

First on the expectations have bit a Can talk around I the you that meeting? the latest submission committee and for side teplizumab, potential little for completed. timelines you regulatory about BLA guess now advisory thoughts

any focus beginning for the anticipate a that So, yes, the point period, areas around we're this and acceptance year. on in of out at this to that from in decision that of the we've by that could can will purposes in the contemplating the for so point. so review toward shifting we're review XX-day priority agency. of next to as context ready you agency BLA, set year begin But we one of the now and conclude potential end the -- which preparation imagine and of with to at the period we're being We letter wants for that about purposes can would committee will lead now there an next earnest now of preparation, the middle the believe from then feedback year, We the defense meeting. for we'll don't respect the advisory in filing agency have XX-day prudent the of it be as review the and we shifted a

the you're little the do around pricing at a on months to teplizumab, just thinking pharmacoeconomic And work eight as campaigns. this work thoughts and then the awareness next point? you some your some latest engagement continue guess the I I just the pre-commercial about to work of payor pricing some bit around in talk of how non-branded the Can approach your updates you of appreciate about over

Jason. Francisco answer the have the call for a Officer. we our to Leon, obviously, BLA, our I So you, Jason Today questions. Leni Medical actually also She's But my introduce may with We CFO. Andy Chief filed and us Chief our question today. colleagues having Officer Commercial have us, with have air have Ramos come that's we for on and Scientific Hoitt, if Chief our we Officer up

to-date the Yes, and we've to pricing of the real of we at setting What before, over in that that impact about X of with and cost in importance payor engaged totality May medicaid burden the positive into from This engage this of year payers payor of the and effectiveness market the in with over feed number research quarter, is been world effective. incredibly it mentioned team. space. that looking We Tom. number now disease models back foundation we've continue we as first that is and the feedback the the that up all of a illness time medical cost engage I XXX mentioned lives. study say right commercial dossier payor Yes, has the our analyzes and continued continued to diabetes. we've to launched the of we'll cost course Those the this be as work we're evidence the to proprietary to foundation will a plans talked that and AMCP utmost Year-to-date, one been access that across directors since do say of and a associated managed will And with is would Type of pharmacoeconomic you of it's year burden budget mentioned, last the I of on you well. payor website them Hi, us so wrapping and the payors is for over the say I engagement can one they advisory the question. absolutely. to represent has Thanks did year. the course our board be as positive million aggregate covered what can and

the of on engage next to early in So part intend year. be pricing in track and we continue research to still

would has we'll our that is price I we of at and final a would nothing price until research expect So, them complete approval. wouldn't say announce with what respect changed I thoughts I that too to and around time the expect

maybe you're I can teplizumab specialty doing some potential on we just about specialty of maybe last on about the see mix think chain And you pre-commercial one how distributed talk pharmacies, when being you and the planning, work question logistics a guess do between of the side. wholesalers? supply some distribution

Yes, absolutely. Great Tom. question,

for question you, Jason. Another

as in that actively distributors addressing moved logistics into all network we've now XX across selected of vendor. pharmacies So limited phase we've specialty states. third-party where capabilities specialty as have home infusion our engaged third-party a the We're well

So, final of making those process in early while next we decisions we'll latest. that be on and haven't made were later of end making this or year anticipate at there -- the by decisions year would the those that providers on selections the

contracting we So process. get through that can the

of think a pharmacy mix I through the think that time I there the approval, more will at had buy specialty I channel the versus and to supply and pharmacy bill between would but guess distributor of specialty be if the specialty work would channel.

question. question of comes Our state from Alethia Cantor. your next Young Please

continue you plan Hey to toward taking approval. in and on questions Thanks. IL-XX And a X the in kind that diligence in -- the how then kind addressing been congrats guess Provention about I little kind COVID -- market just also Phase just progress hard fully or perhaps change from maybe how opportunity my would side of of thinking that. and first you're what about just of study like you talk and the has of you some acceptance be challenges celiac it you that? on you as looking run and see the market in for talk one biggest of the maybe can challenges, as like the bit and the light a guys, thanks due move like can for and you behavior and about a there on non-responsive

Celiac. then Jason our who again to hand provide and Francisco could So you the to answer perhaps is expert first the question really in over

the progress change to of to campaign at intend awareness last launch I our disease has end with of question, your answer think month. and already the begun physician So the unbranded behavior

as being thinking and we mentioned with endocrinologists educating the specialty for the toward weekend screening who distributor, geared often assuming infusion. the a infusion drug capabilities observation in paradigm about the area why planning when in, already one this talk course incredibly we become consecutive comfortable infusion endocrinologists or on home those pediatric get engaged the that is being a the we and when stages research are them through as home the can on risks early to potential to change past, think And transition a that XXX and screening this disproportionate flexibility being diabetes, talk the infusion for they by campaign pharmacies, of with built that of concern the we about excited of say this and the they're members ensuring of based the should in acquisition. the risk I done, and in we at is to shifting XX to screening as of if And that early about they possible. I have having to physician the a of then disease infusion not know profile start family in year. respect all the TPP trying X for and then we've in And allow that One, time that diagnosed teplizumab specialty to of product providing has. endocrinologists pediatric early we've are day that Type that multiple be anticipating pathways of So we've market under to center would patient through obviously one point. we're in present endocrinologists more them behavior than over

address concern. I minds infusion be working of we're at concern physician, present common there most area think I see to respect of with having you it to and to of we start when So potential area set home one actively the think to the that

interception behavior or biggest outcome an could in From antibodies absence Francisco the to of make change call in been takes disease. the Before single the are that two has meaningful perspective, therapeutic in difference that my as intervention the stage to identified patients XXX. a the having inhibitor on early

indeed So interest are seeing groups the level of patient change catalyst and in already an and that terms with to interest advocacy XXX. in availability of X of is a teplizumab therapeutic just existing and interception having availability the impact and having KOL potential the we Type diabetes screened. like the the relatives patients the of Francisco, catalyst

So with respect opportunity. to commercial the

large has the So, as disease you celiac therapy which know, no last autoimmune indications, of is the on the market.

So affects substantial market, non-responsive total it's of in Americans population very a US. addressable disease it celiac X with million the

test. million total with So we celiac One a who The is the market. COVID of has ranging inflammation number this initiatives that endpoints is endpoint to outcome. have endoscopy key the gut to primary has which Phase four the Xb inflammation. a X trial reported pandemic. a registrational everybody COVID, endoscopy respect as to endpoint of disease And part undergoes assess addressable symptoms, secondary of address arm requirements A gut dose is a patient trial,

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interest trial. the we substantial see So in

swing on little logistic. think guess will to you execute follow-up health be important in-home one do how think I bit talk in-home like kind of can and an nursing that's I I mean more someone mean it do a just infusion maybe about you Just do those these you I sorts of them. factor? hard

close you've a So with Could been access market look taking comment? team. at that you Jason, yes, our

Yes, absolutely. It's a great question, Alethia.

they confident we'll at there of partners infusion group looking think the specialty capabilities there are a there that partners home criteria obviously find want pharmacy across -- the and I have caliber one multitude them, to think, we out that those would right all conduct and selecting of with is in are And key be going be out able exactly to of key of limited nurses speaking thus it criteria gate, partners infusion key element that ability as the that ensuring we'll patient's working our the states, But partners. to on able accomplish see of infusion to I that I'm entity that is for evaluating XX have would capability. they comfortable, a into to number infusions. we're a that we'll and be home more infusion exactly able probably with our home expect with we're I these a right providers endocrinologists right transfer the is that home because starting to get based encouraged of would pediatric I far. center probably that been be And new this the that that right that may the they search to a for that find evolve patients we've to I'm an would. in to the of partners time, to over ability mix expect and when molecular endocrinologist

you. Thank

comes state question. of Justin next Our Kim question your Oppenheimer. Please from

questions filing. the the recent congrats progress on taking and the especially for Thanks

a few might screening we hear the might a Do updates me any nationwide metric patient of awareness in be and from Just potential with you ahead family groups, of programs perspective expect from XXXX? physicians ongoing. reaching how launch or in many a you terms

have Obviously but in that Jason regard? feedback you any might very early do thoughts have about we when days,

campaigns these one that of toward and the consumers providers toward geared right. obviously have just two and healthcare really about out. campaigns So geared excited One the quality we're been put

messaging of the caregivers, you we're two themselves with campaigns, including those the at we -- here. That two so has media campaigns, to look picking that audience, market really our concepts voice said that really I in those engage the note being to there pediatric extensive patients are campaigns of endocrinologist, research feel think the those looking and traction. endocrinologist, really that's captures from everything it's up and come when important and content the

of metrics, form little the but I the months over initial campaigns to course and and as more forward think on premature the reception we to any coming And it's providing we're quarters. details to about the so encouraged with of we a traction continue look talk gain

you of me inventory into how away going cost, P&L color side, give up and additional for maybe on up us with R&D, sort of just plan maybe And you the can CMC forward. just mentioned I know you to pre-commercial but about sort maybe the how wondering would going the of that spend for XXXX? expenses you just uptick for on Andy any think in sort make build

We Yes, has call, wrap certain extent. costs QX validation the really we around as batches done I be to costs. this qualification the wind discussed also obviously to and BLA down included PPQ impacted as R&D a to on to QX year related cost significantly those all the related CMC that in and work and these right filing up there costs was expect those the

expect the pre-commercial the I So come costs, as BLA process to which I those through the do out to ramp. here expect progresses there call those in down. continue to XX-Q ramp regulatory we the will separately right

in which of in I important QX. are $XX we note, to a million, think than it's $XX projecting million less obviously spend it is was range to QX

little more context. So a hopefully that bit helps gives you

hear My final side. maybe interesting more transplantation. science on to just cell It's jumped the potential when of really beta the is question teplizumab about to

teplizumab if you there? perspective there that just Just type that evident would I'm of wondering benefit. suggest share any could if details any from a wondering have are biomarker

be the and been -- nephrologist now, mean and hour because Leni, on eight wanted this Leni, to in So basically her eight is been calls it nine, the -- therapy Leni our for weeks, not in investors and because do transplantation the answer five-day hear where effort. days of adjunctive hidden you cupboard could clinical she questions for weeks, who she was that's wasn't to it having a right, has focused from away has our team, has week background. beta at get to team some I insight your an actually you've opportunity this so her from of I like XX Justin's gotten you day with very months much congratulations the part incredible executive hour analysts. and to you it know a cells us. is seven days But biomarkers. question XX-hour and interactions filing with BLA. about to answer therapy frustrated transplant let's potential Maybe a

gave to transplantation. of Ashleigh an Yes, you, incredible dungeon. me of finally for the indeed Thank Ashleigh. cell out the beta get area But key the the teplizumab potential

this fact transplantation ago. been half has molecule and decade islet in a In tested cell

of do immune efficacy to in modulators addressing we continue number we autoimmune it we going response has teplizumab into autoimmune going small the it the hitting but with setting alloimmune alloimmune that that because that's of the another slightly cell in evidence both is its because the beta So need have a develop the to to to transplantation new have now transplantation, be issue the and when will to with go component address potentially beta deal and component. have to traditional cell individuals, immunomodulator

be performing. would at you thing common that Now look to biomarkers, with would is beta how cell the respect the

insulin, what do, release who so in and the exogenous people they And cells you way C-peptide. the insulin probably receiving have that measure beta

transplant. of that of how your really you that common cells easy sure protection your beta easy biomarkers follow protected could we C-peptide way, very, very would to progress and to obtain biomarker an but there other is I'm you modulator So regimen. at, they and beta be more will transplanted did the clinical of the a if immune cell novel a you by are biomarker way that gives look a sense

you Thank much. very great. Okay,

And is it's as pro I call then the hormone of endogenously, beta but a produced the that terms body others around the insulin the active blood cells it on into glucose hormone for and other C-peptide. is then produced in a know clinical the enzymatically cleaved the Justin of knows units, managing this as by effect insulin, and has the two chaperone when part

could is you as get injected be if how very been blood, by which what's of combination you patient So insulin a measure exogenously produced measure insulin therapy. what's of to as good made opposed a the been insulin well as in C-peptide, as being much the endogenously

from state next Our David your question. SMBC. question comes of Hoang Please

congratulations the guys filing. Hey, quarter the BLA and on

significant expect should of and you and ahead the at-risk approved patient we the few or of see traction think I a approval terms screening such screening campaign product market. with of on of guess you something population. just the questions once it's sort first eligible that is a So the in me. is Do more this bolus the from

So, has and actually I'm screening stand in and give States important you been us growing an just and give in becoming and going Europe. maybe to status because the just can a to ask the world in a time, the throughout you things more stands more United and Francisco to as update on where the screening Francisco, snapshot when

their already between TXD the family like screening decades use kid should absolutely. test in antibodies Yeah, context bring have by because clinical and and now FDA when big takes families, with they We run LabCorp that of approved they something parents, are on place for another clinical kids to differentiate that Quest. active the for labs are going and tests the that's in

patients. -- going the So in that's at-risk background on identify

academic On hand, another the has the large XX there TrialNet. are consortia, years. subjects. In patients or initiatives, in probably the run there total studies million that X several added X.X screens TEDDY have screened TrialNet have and we and groups as other DIP, Europe that million. US, consortia are consortia additional screening past In close C-PATH XXX,XXX very probably -- well, probably to with and ASK,

once a going campaigns. and the families on your we question campaigns drug in and like increase exponential for result even today will for is growth our diabetic this helps nothing in is of our helps expect answer the estimation market, to further future on of this all screening the become be unbranded a there disease driver is to as ketoacidosis while So having the There also background motivation teplizumab and TXD avoid the prevent to to prepare though DKA, because and screening.

of So believe potential increase we the drug a the market. project screening and once in do is substantial

established, patient indications in to over And like has is general intervention. activity work TXD the with some places and groups celiac lot that are TrialNet parties know general you the the population ongoing and Finland respect with seen parallel a a population block like is the screening and consortia autoantibodies interested of advocacy also therapeutic to increased well general line you've just doing the to can in screening. but time in with countries like along up screening we efforts the ASK possibility of to on of are to We parallel comment for you Francisco or if very antibodies been of population the absence

Ashleigh these countries for is leverage the Finland, where The general is child shared consortium population well screening, promoting a more Virginia a of in general while a countries indications. lot And for that have you this US. because virus visits. the the Coxsackie private all program. can there is shared medicine autoimmune In ASK intervals mentioned TXD we been screening And a know trigger general are both of have preventative is these like consortium come synergy B Germany already with as like are to screening disease shared as patients celiac identify and Nordic already is there triggers now genetics, a into children population population screened at in

one once strong to USPSTF recommends, teplizumab will the groups done which certain age level. in in Task So Force, to that's should that given guidelines be screening changed be United others. future population and American the American the The the at intervals in we potentially is guidelines for general market, to in for the screening population very there issue be Association Pediatric day guidelines entire like Preventative at testing rationale which recommend States into the see US the the Association Services and Diabetes national

the you about I exhaustion that and with want T-cell of markers And -- potentially before know other doing I then point to talked at flow the I looking had cytometry. focus redosing. by on is

out to I get a ready do sense that that or big and up just quickly something assay think commercial setting take you you to at you to want you So set would that of get in think focus roll type is later? is a have kind how of that can launch the

comment barrier assay at merited? want determining marketing setting respect already is T-cells and for to if a encountered commercial biomarker in us be that may consider studies where a post to conduct to able a that do frequently you exhausted be to So dose when that the Francisco, indications. repeat being all well on oncology you with to maybe

you. thank Yes,

is hospital need to because they hematology cytometry ratio, flow as services. at in is So, any David, oncology infectious conducted routine or a flow cytometry so CDX assay They tertiary the where diseases there anywhere etc. look CDX have

exhausted and the positive samples be adding cell test, a not positive which of looking double it is CDX positive, with complicated matter is a it's So in KLRGX room temperature. shift done positive at can for very our T-cell digit

not So, blood to central at can temperature, shipped expensive be room a very lab.

just labs just few a are it for few So, set and assay initially, it done the and assays will around matter just locally be the that level. in can a be local of validate months then more already country slowly a labs and will more the to at these the validation

Capital Gregory state from your Renza comes question question. next Markets. RBC of Our Please

for in the team. rates at-risk of population, given in really Congratulations this you curious any, have light light screening the you. just especially TXD the what thank be pandemic -- under just virtual morning, tail similarly lines, teplizumab on pandemic? for long commercial observations, touch Thank my progress, what on are for the the side, I just you maybe Ashleigh. And the taking potential in Ashleigh the on unpredictable a the a and you prepare just the pressures, launch hybrid maybe consideration profile? for certainly what to of on employing or potential good front Hey, In questions. and strategies or XXXX, to if wanted of on would

comfortable this philosophically is the a Thanks, with operations and virtual question. And very on managing Greg. company of first concept culturally, Really -- the basis. organization, we're virtual appreciate a

build into to an we going individuals KOLs. us, next the and with hiring ultimately relationships our get leadership it's the pandemic I Jason the over that think then and winter our of gives foreign in to on situation that is to we if and might team COVID terms control us of contemplating his we how not and both scenarios which and now with team And the year, preparation, launch with and hopefully so, believe see sites surgeries clinical advantage teplizumab. through situation, respect approval, we on various depending as obviously work outside And

a initiatives screening are Jason, about are some perhaps know carefully mean that dealing as absolutely talk studies, well? do about you can you definitely as very, the thinking respect well think through get we So, lab want as talk that into evolving, PROTECT. our or Jason, hospital do this to commercial screened want there. phlebotomy patient to very There doesn't and and Maybe of you ongoing are Francisco that, with might about including help the I talk of this through that management have we're with to But obviously to a go to your plans?

to that down readiness do a would the endocrinologists of the relationships sales what importance bring would groups, company where things So readiness in endocrinologists. as is as target that an different able launch internal world from away pediatric mean, want to through would less on-board what group it you launch planning. of year a is strategy, have launch interdependencies kind we the imagine, even between that where or we maps is of and so, readiness our than work of of additional they group to our the the And the can we're even the we pull from audience across launch tactics a in What it need all contingency being approval, focused have need potential back in -- we people working they be differently to in on that COVID today stream and COVID one COVID-XX spring? to exists Right? do of may entire a that thinking out were to virtually, with where the already situation that, we launch to profile and

think news pathway worked the today. and preparing so, physicians speak scenario. peers are and The pathway where And company set industry success to in And possible our get actively there into hasn't to we launched able get our will in and a recruiting improve from By is that doing will world into the actively first we COVID and through been of to that due world in approval, we're best and ability and those the best year what's those that world we I have COVID. we're promoting right. own A decision-making launch there to launching have team have launch a been play start of and we what factors a the for a that numerous be going in and/or tactics be there having to are is into we're to practices time lockdown the next other to COVID start up the face-to-face. are will the the our either companies things a this. for that in a in aren't implement And we we advantage almost where leverage all able actually where parallel multitude things and have path, get good we that virtually as and

the can the go determine and a into blood Francisco, alleviate There that And have that Jason. well. entities as have to is commercial center are tests they need developing a if Thanks, are autoantibodies. phlebotomy for screening to evolving child a draw

Greg. Exactly,

soon. other it's now here pushed home the time, in it by is commercial of is available already is will in being sake to but it's pioneered that And not -- yet, that the for be at Just development, home something but already testing, testing place now at dysglycemia TrialNet, organizations.

question from Wainwright. state Please of H.C. question. next Ram your Our Selvaraju comes

dialing I and was start with off question a This to few just Boobalan in Selvaraju. asked is questions previously. Ram have that the for pricing

attack and could That's how what the teplizumab first drug's when for you you maybe drug can elements the impede drive and So, determine taken plan do on the if what and be into to the to could long-terms these would outline penetration elements? what of price factors adoption try question. near you during consideration and the

that drive you. and taken could pricing, Thank factors consideration elements the into the adoption? Jason, or impede

both finalizing to the X I diabetic a real in and in medical mentioned diabetes, in like process effect of now a study patient for the costs the cost past, anywhere $XX,XXX, looking at type with associated that's as a we're think we've evidence right admission a $XX,XXX ketoacidosis direct things can right. from indirect fact world to single So of

All life of and direct for this etc., things that will impact treatments, analyses cost costs, costs, out into inform will the of stays, and pumps, but that cost of clinical take glucose be factored the medical all that the hospital study. years, data our medical of model Then our tubing, we'll model, budget costs real consequences the value various proposition. quality foundation evidence and adjusted effectiveness effectiveness our both all all of also continuous information, lay all downstream monitors, world like analyses, input

where the put Now, those year of now goal look from be our that combination a of teplizumab the study a case we authorization pricing. with terms data in Obviously, label with data may the three-year products. at in to evidence payers prior is -- our place be of and flexibility a is value our get most from with have in will real research specialty pricing formalized early in proposition world study to front of to as part next ADA the coverage what in to

able to toward, year be what of in that's we'll what that's that early the geared exactly do, and the approval. we'll doing and is part payers the so, of at the to is we'll And we'll research what that disclose with be price doing time working be be next

with your been lot Jason, has median two-year a to-date And the research of outcome.

only get June. that better in data follow-on I presented was with think ADA the things at the

to think a research a of incredibly can label, hear. what I which inform we in formal think encouraging label. means board where help representing most to than and payer mix Managed pricing to intent to The directors covered anticipated to We with us pricing prior the expressed commercial, authorization of payer more a May number back advisory did and getting with between that their medical was I Medicaid a Medicaid, XX go our million will prior lives across cover authorization in terms with

our a help approval that research committee the different and inform tested to date. to make a formed recently scenarios decision will close So, that we of during will pricing be as number get

type what and other the respect positive on would your like diabetes adoption, than terms within X you the that autoantibodies are would factors with are of of got have then clinical five convert indicating other adoption? stage years -- eye patients in highlight driving you dysglycemia And that what there to and any to you two XX% to impeding

No, of it's the a second fair point, question. Ash, and thanks of for reminder the the part

to the and observation of to possibility with providers, healthcare of transitioning home anticipate the Alethia getting that, is does healthcare be home home an bring providers. -- certified well, so would minds research getting do XX that product that in infusion at start raised infusion, it home most under target during profile center day infusion infusion we're are and want question, you the consecutive think up uptake into whether an I a I once encouraged. the the to see infusion how then the asked about would from say, the they home, question as or home, most we earlier barrier to talked think you infusions at patients' often we under can alleviate impede we And that concern the of around teplizumab, doing potentially transition the that nurse when in I weekend market those infusion. earlier start

barrier in addressing is heard we've think So, most market the certainly commonly that I that today. seen research

XX remarks if to is for we our as intent a of a in at indefinitely stage considerable to to enormous in potential formulations clinical the subcutaneous perhaps fantastic progression mentioned of the not days an X have value minutes XX in infusions is XX proposition with diabetes, period further the and each to obviously introductory But improve -- type day some delay dosing look a is patients versus time, situation. the multiple also of

comments. our Ladies for conference turn Mr. conclude will I session. Palmer, closing question-and-answer and the back over gentlemen, does you to this

you, Thank Cynthia.

updating you, and Thank We that very us your our thank joining loved and progress, well. hope much we today. look you. sincerely to continued soon everybody, you stay for and you on ones safe forward So,

today's you This does your thank conclude for teleconference. participation. We

You time a may at and disconnect great this have your day. lines