Provention Bio (PRVB) 24 Feb 222021 Q4 Earnings call transcript

Good morning. My name is Irene, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Provention Bio call. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company's request. to call like to now would turn over the Mr. I Relations Vice Bio. President Doody, for of Robert Investor Provention

Thank you, Year operator, us Conference on and thank you Bio's Call. Quarter all Fourth and Full XXXX Results Prevention Financial for joining

today's Officer; Ashleigh Chief is Chief and Leon, Scientific Thierry Executive Bio Jason Co-Founder; Officer. Francisco Palmer, Officer Co-Founder; Chauche, call and from and Hoitt, Joining Provention Chief team the Officer Chief Financial Commercial

statements. SEC our make These approval success you remind and statements that potential securing various today next me constitute for over product and plans let candidates, other with the will the forward-looking may Any continuing efforts XX-K, represent developments we most XX and future results, forward-looking clinical the begin, annual may the of well teplizumab we catalysts the SEC our we forward-looking review our Form to differ our business materially from recent the towards or time and Before results on as efficacy business and at-risk those impact morning, clinical commercialization lines make indicated delivery projections, our prospects including views potential our which FDA discussed commercial the result indication as and of statements our and continue in future. our planned these the regulatory include plan candidates, other other remarks about including in of working months, the as the a important an teplizumab with expectations, and FDA as related resubmissions we a in report and and product to plans significant as our COVID-XX and factors, BLA they potential of cash and safety, today Factors runway financial the Risk for anticipated our that Actual same. plans, cash of of our with use studies of our only. and section projected including statements various by filings filed timing on those this

While These specifically except statements on to Therefore, disclaim forward-looking at these representing required these encourage we Provention's more if regarding change, not on you risks statements, is our will any views Provention documents and by Ashleigh. There review reports some today. the as the as the of future, obligation we forward-looking the should to do SEC. uncertainties With you complete law. over www.proventionbio.com these to forward-looking documents carefully. may turn elect that, point so our We section. available to website information filed with as in Investors date subsequent even to I update any at statements in under views are the rely call now

joining to and thank Thank this morning's everyone you call. you, Bob, on us

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line of the results by end top trial from for date target is this year. next Our

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launch second in you teplizumab's We and in-depth with focused commercialization. TXD on potential are insights also the investor and providing more event regarding educational conduct quarter planning details an to at-risk

ask your Jason? appetite. to update with Jason whet However, brief to let provide me now a you

great Thank you everyone. for today all TXD. potential and the you, in morning, teplizumab we're Ashleigh, on commercialization speak and I'm excited making provide at-risk preparation good you for to of with with update progress an our

patients. shown of team course commercial both of To readiness than across health depth to has enhanced at-risk understanding market conducted XX% is a patient, X,XXX their launch participants including added of remarkable. study others. and for they to key care and blinded XXXX, we the patients, the Over XX have endocrinologists, product and with stakeholder our research adult market quantitative prescribe audience, providers, profile product at-risk breadth patients, our In teplizumab target in more substantially caregivers, the date, of their the which a payers in both recent intent and next indicated when pediatric quite for

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a alike based our barrier it presented of of days X,XXX research, to another research patients. of for XXXX. the screening care their deployed screening of adult members, understanding after about consumers pilot in the that increase the scenarios target treating treating firstly, family consecutive they both provider offer physicians. have ketoacidosis; including XX has learn health product than endocrinologists, team team education, on intervention XX educate have enhance indicated as This we as become more interacted our TXD in team teplizumab such the included team health relates providers, been educational gathered for infusion, diabetes benefits has plan. of To type FDA-approved providers. XX% The the quantitative across our country that time both teplizumab, potential providers the care. The insights, to over calls the of care goals viewing person strategically on for an study and they and when largest to middle multiple market health secondly, this TXD further members to care overcome of X,XXX comfortable will avoiding health To further placed with which a enhancing family pediatric are to much of endocrinologists the understanding valuable to providers Finally, use environment, care site diabetic more at market with twofold: first-degree X commercial profile and

since awareness As X the a we've engagement previous see calls, in level we late continue I've In campaigns we and mentioned XXXX, launched had of high to on with screening social platform disease Twitter and and engaging complementary Reddit awareness sites. also account the market these consumer fourth be channels share to drive to as our our lion's we've disease driving typeXtested.com. traffic the seen of media enhance consumer awareness audience, and highly disease quarter, with

unbranded the testing, social connects drives TXD Our an more. on content autoantibody with and educates engages to and TXD people the risk, to community learn website

have accounts content. unique and seen of substantial Instagram Facebook over with Our our XXX,XXX engagement traffic

providers social media launch intend to As community. channels we and additional for TXD XXXX, we the enter health care

in access. and we engage engagement care also and to to blinded engagement addition providers direct health In research XXXX, both through consumers with of continue payers our of market market our

has be dialogue feedback We We once been encouraged heard our new targets payers on to of the the and we've continue look the positive action the by unmet date from profile and to feedback with TXD. furthering their need teplizumab the FDA. in forward payers it by set

our Finally, to limited the distribution in of regard build-out model.

at market network We I'll with be of a turn commercial now discuss We and the provider, have potential over to specialty to distributor logistics FDA contracts our plans call with and move we Thierry approval. look implementation in to on further out are the track results. time place to continuing specialty third-party of pharmacy limited XXXX. build our that our the into Thierry? as forward on financial to update ready

Thank you, Jason.

as was factors prior the to condition. discussing encourage to would was today. financials statements, XX-K read I release, analysis XX-K financial includes quarter, as begin press the our to financial attention issued risk that the I you your also our well which I and this call of earnings Before would filed our for discussion The like call. management's to

Let me position current our start projection. and cash with cash

As cash was position and of our equivalents marketable XXXX, cash, December XX, securities million. $XXX.X

ended expenses quarter the Our XX, fourth XXXX for cash-based million. was December operating $XX.X

requirements expenses XXXX as business plan, million between in at current cash, be December at to marketable expenses. We operating we XXXX cash-based operating $XX XX, securities meet believe quarter are cash the our we the that continue expect our $XX our prudently XX next hand million our to equivalents of on gate least and for sufficient our months. and on first to Based

need BLA teplizumab and agreement, in we increases commercialization payment triggered is MacroGenics. milestones with the to will if current the capital related of under fall approved, potential additional costs including However, to our

quarter Also attributable by regulatory the our initiated IIa net with fourth to was and pre-commercial This stock compared in teplizumab PRV-XXX offset that for Phase performance-based PREVAIL-X lower compensation and increased loss activities vested PRV-XXXX costs. partly our were decrease We teplizumab. loss progress XXXX metrics regulatory by continue to additional for primarily to recently driven commercial and perspective, option will approval call loss of $XX.X provide From fourth to guidance the of $X.XX the and quarterly net we basic The this P&L on quarter for decrease towards diluted as the for million of we and or $X.XX potential share a XXXX per loss manufacturing a the lower lower cash generated basic net costs costs noncash $XX.X compared XXXX. study. of contributing of net quarter expense, launch diluted to share prior a is in stock-based per million year of or the fourth period. and in

the medical diluted net XXXX to $X.XX attributable year PROTECT, XXXX, was PROACTIVE, million net year per noncash to of loss and net cost increase we increase million general share diluted and included teplizumab of expenses basic and $XX.X offset organization and lower start-up An over for teplizumab. for the build preparation to loss The we compared in I fourth $X.XX expense. PRV-XXX $XX.X of activities second net basic PREVAIL-X million as affairs precommercial, the for loss into partly recognized $XXX.X the costs commercialization, half began of lower collaboration Our by the stock-based an XXXX, in regulatory in Huadong. call per license or administration or was to noncash million turn as in share of in and which increase full agreement in The - teplizumab XXXX. The net loss August quarter million manufacturing with initiated loss under in $X.X with XXXX of over for compensation. $X.X of a compensation Also, cost and comp-based included revenue will our for was back full Ashleigh. XXXX. study now and XXXX

great this teplizumab of in irreversible tremendous TXD a of XXXX, we our interception prevention in burden therapeutic a Thank delay the of to Jason damage potential at-risk a turn, their of individuals, or whereby true paradigm with progress move be ahead world to Provention. are year the living less shift like advanced-stage individuals and to in start disease platform allowing in tissue clinical realizing and ones to deal will a any impacted disabilities lives the organ excited With on Thierry. management be stage that, and place focused validate them their and questions. made of planning to their off forward for is our conceptual and we'd all and believe In better making very catalyzing of the early us. will so BLA, for potential, you, for be take approved loved already disease. doing, possible We in operator, and for focus which risk, resubmitted launch our by autoimmunity, potential and on are autoimmune would failure. Having pioneering the We we we

Thank you.

question [Operator ahead. Please Gregory Renza from go begin the Our question-and-answer. now Instructions] of Capital is will RBC first We Markets.

and Ashleigh Congrats progress, this morning, good Hey, refile the the team. on weekend.

that and of to can by can if education hear just Ashleigh, teplizumab the mention to does in year. clarification do think that on merit at-risk maybe over we helpful you. stakeholders. curious perhaps I'm appetite as Maybe misunderstood investor that components on with your It's Jason the start there. elaborate you that, any course of or those of population Thank the well. you specific is I'll start touch of

product. for the details to misunderstandings. We're seeking much correct Greg. for more question, very wanting We're really pipeline provide Thanks to really not our

can appreciate, year, in you individuals. the focus on As last at-risk teplizumab during was

So and on. and to teplizumab two, opportunity to into perspective, life platforms well to year, understand last make pipeline. opportunity teplizumab during to the commercialization regulatory commercial that an that in We've mechanism again, this been cycle as preparations the outside regulatory second particular half has of focus the an of of appreciate considerations. sure dive on focused investors And respect next so of of we we our think a justice our conference perspective, gave investors enable then quarter. course quarter calls our And a TXD we the potential year then potential our to the in from do to investors deeper of on we questions details will leveraging management to of combination the had in technological from the you from the pathway. expansion and label as with very of analysts want and I XXXX from throughout action and And of company's detailed aspects and therapy rest obviously, rest the on think perspective, Jason's providing want

you. that? Is Just something would Are expect regimen. on disclosure course guidance color we work hear to time? That's dosing Thank the of just your look would about be updates. comfort We the and on to the a with contemplated learn respect forward that curious in when new short maybe if And level on FDA being any I'm we more on provide great. plans maybe refile. those could to helpful. just that you waiting with FDA perhaps would we really dosing some your for

question for the again Thanks Yes. follow-up there.

obviously, or certainly, hope within XX as will normal milestone our And interacting updates earnest, exception. dosage and begin And resubmitted more the point, So to fix some we accept perhaps there, and potential review material on last we FDA's their I the as that we And soon agency that comfortable to process days. regimen The review be week. we as negotiations. that acceptance as it. of will they be be assuming part would if next getting point, would that of then At they And with begin we would to think adjustment quarterly by we to during a hope course process, approval. get that will the to - dosage potential anything beginning the disclose included them in the discussions be for feedback. that publicly the discuss regimen labeling there's in

That's great. my these taking Thanks, question. Ashleigh. We look update. forward thanks to for And

Thank you, Greg.

SVB go Thomas next from Our ahead. Please Leerink. is of Smith Instructions] [Operator question

for outline on to this the PROTECT. BLA kind dialogue implement to Are Thanks the dosing the progress in you morning. what to plans just good with guys, the the in PK-modeled regimen regulatory any dosing respect ask regulators, PROTECT? questions Hey, taking and there on the are one study? or I study just with respect could side for with Maybe on if to resubmission. of any congrats and the plans engaging wanted

Tom. Thanks,

by the therapeutic that strongly I And that agency material products, PROTECT XX do system, have commercialized and XX necessary that mentioned in in There, powered. similar the well differences the we analysis. PK both and remarks, therapy years gave some risk. FDA's the different. perhaps both to confirm of impact material be So only the mitigating in as the is patients in two used a study also therefore, that immune they whereas that hope this my of drug to products been that we - feel dialogue recall the in We in PROTECT that we're on be drug make impact We and pharmacodynamic XX% of that We may years with TN-XX the the study. to giving obviously between clearly ago study they're believe we still over-enrolled that that. opening as had and to TN-XX, manufactured we're very And is efficacious. had little context sure that, will closely one. sufficient was intended a monitoring consideration. PROTECT, Also, lead that comparability used PK helpful courses ago despite

I agency make sure the manufactured TN-XX to years like XX think TN-XX study. want we, given the the sort is The concerned duration ago. a with year was XX, X study of They, materials that course patients be get the get going that exposure received patients the that potentially get this - median single with to to days of XX enough exposure commercialized forward, products. X-year TN-XX matching the delay

group situation we're help? and conducting and trial III Phase receiving product creating product. we with modest that's the commercialized a patients of receiving PROTECT so without that one in some any are courses And that I one different the adjustment think in with than Does therapy to-be dosage accomplishes a other the and iteration two that concerns, where the

of looking Ashleigh. Thanks, like commercial a terms yes, just activities where manufacturing little the you next then And terms planning supply? and, of to feel the potential in No, in event Yes. helpful. Can question quarter. forward you bit in here are that's a launch Okay. you about and talk the commercial

Yes, thanks going over for please? to Jason, that question, Jason. you I'm that that could hand answer to question.

Yes, absolutely, Tom.

that and supply later adequately are this then our obviously we've finish to and with been Biologics stocked feel year. manufacturer AGC fill, the launch So we working

CRL. update CMC were then any issues the But in that cited I on issues were And also other Great. you August. just us other had Okay. and A Type outstanding lastly, the in of the if manufacturing give you back Ashleigh, just, maybe potentially that were meeting know could they cited. an

latest you issues. respect on the stand guess those to where I Just with

Tom. Thanks, Yes.

time you some we'd some represented if And the in issues of were already by the to to which issued. out A CRL first we time were with of then agency. action for walk the felt sort So the through believe, meeting of we was the our had the we of I recall, their to abundance addressable. but those and, the done Type time addressed, didn't plan review CRL, to have were an August in was And those our that And thought caution, satisfaction. agency address

the we and on resubmitted all focused BLA in last so CRL comparability address basis on that, considerations. week the the the of to of And PK

for congrats again okay, questions it. guys taking progress. Thanks Got great. the the and

Thank you, Tom.

of Our Kim Oppenheimer next from Justin question & Co. is

on taking for quarter Hi, good the Thanks add the year. this progress my and morning. and question past let congrats me

a As do I approval know timing post label that you be included think studies of for these expansion? initiation potential may how the potentially expectation explore you PDUFA, about the and and approach how and as say, post-marketing expansion any delay commitments. could approval items be are small of, But that might let's studies ahead curious be done that label whether there between and event. the

you much. thank Justin, very Yes,

specific have include single agency X regarding, something and spare But dosing design of while years. discussions much to are have their a to that also with And the way for PK on the in and example, We single to a that interacting for modeling don't but to patient agency the if to we time, have will working outcomes. dose, be address been the very resubmitting obviously we that by same re-dosing. provide The enough cannot the been just protocol, our the has dose. the post capture follow-up only the label registry BLA can we're ready on marketing, data So obtain the we agency with to specify it team fortunate and believe study, and information approval. comparability, under from have a be specific necessarily a with

present to agency's certainly, in have inform agency them that approval to include to And of payers expecting respect would the at their type We get it the and label. data the information be that with decision. to

up those So get very upon thoroughly. approval, And we have a relatively a running. thinking be and to you smooth I been process studies about expedited would and initiatives potential and think that this

scenarios potential color share additional currently? site understood. care in by you to pursued the work the creating of any being Understood, hear really flexibility be able And Jason. interested was to Would on on

Jason?

intent Yes, intent flexible and/or our by of of that that as previous be. to teplizumab needs the consultation site or absolutely. product ensure respect made are is as patient that with that can health Thanks calls provider. we Justin. a really question, available to care caregiver before and being our we're it's of as care infusion in we as mentioned for possibly And that such, with making acquisition to terms the site their I've be is on decision in

little let that me So on bit. expand a

with center risk. infusion bill the We to a that J acquire patient's not take ahead some product for centers specialty our provider will want miscellaneous can and to that hospital their So code, may in then example, launching know launching distributor the go teplizumab a wants through be a that infusion and infuse patient obviously insurance. and

in go few So they'll have our days under patient the Should or ability to pharmacies. observation network health provider a administer product white through specialty and of to center to And where first bag one many want the however that. center, care the and of limited ahead hybrid may infusion can something be, a infusion days transition home that an they model like start in call then they infusion. we'll and do that

pursue that We I and then will of health initially our But option infusion of most available have pharmacies that patient a our providers care in a benefits the in health X care we all that home start home if health the providers patients therapeutic, that have think they well. remove care we wants be to doing an to infusion, as think the to this longer-term a alternative obviously more that with be provider site care want and is capabilities intent the take. the will those center. can and/or of have making and specialty network in XX put states. we everything infusion think that one as should decision that decision, patients of We as the lastly, hands novel that is to barriers in many of will possible. And

Great. mean, potential final to with that been it. Great. teplizumab. approval curiosity. the the just And Has your there potential better MacroGenics needs? cash Got or payment specifically business I associated agreement any regards to align payment to with with of a restructure for

the accordingly. to things. investors takes of There's and discuss be if place, that And always types - those updating potential you the we'll

Great, Congrats progress. thanks. on the

Justin. you, Thank

is Our next question SMBC. from David of Hoang

can to And months my congrats the you, And channel into if - the force for the drug do and just eventual in would thanks taking rollout, quickly when be see so. that the capacity? the get available I How of on continued I first commercial the to to sales Ashleigh progress. in approval the the XXX% you patients? guess, consider PDUFA question. we and wanted at an on X Hi, ask get team, or you next do terms feel we assigned, date and

Thanks questions patients there's being then the very support of scale-up with force for appropriate and sales question, infrastructure. discrete the there, one, full that that the have X other, ensuring access David. Obviously,

you to So imagine nature the us hand especially breakthrough access is I'll teplizumab. that one But to given those potential can important Jason? the over Jason. of

question, the David. for Thanks Yes.

the channel to So the to product one. that, is available that a with answer we levels support but right experience as and the background is, of initial can, providers quickly into and positive short in is sure the make made our - get possibly to intent patients our the intent as

the and throughout past, we've as And year. on to we're we course as hiring milestones, spend gating our goal so in FDA our date. the as provide as such, clarity to we'll shorten can action as the as launch be fast the mentioned a new and regulatory additional can window to much able possibly gates to is of based possibly But we And upcoming clarity. our after

if a just And may. follow-up, I Great.

time regards in such, for restrictions expectations just, label announce color, or of the terms update then sort the terms imagine you're pricing thinking from there the at kind And of of of as on tone their it? product launch. I to In any these closer want would expectations anything meetings and terms to the kind of feedback probably that - any of about for is or in discussions, restrictions us their you that in And how payers payer to of see it?

David. Yes. Thanks,

I exactly agree give think, very But would from feedback Do pricing you're encouraging you you're Jason, with and to details payers. that point. you respect right decision some a want the the to to seeing David? So

David. Yes, absolutely. Thanks again,

on. We time at spot price approval We've announcing the of the anticipate you're a road. completed would potential down a So our research. pricing

close pricing relatively action committee Our price a set to will an date.

a the really continue of consistency But encouraged approval, that yet. heard with over So we've that. haven't announcing set At the time I payers course anticipate X of last to we we again, from feedback be the the price would of the years.

this prior anticipate that what planning is we've most hoping think and which is label, benefit are cover and intend authorization to a heard what that medical of covering I majority we with a look strategically recently the as this vast to for. and payers

taking Okay, great. Thanks so questions. the much for

Thank you.

Young is Our Alethia Cantor. last from Please ahead. question of go

taking Thanks the the my guys. launch. getting starting of line back Hey, Congrats for on to question.

and Jason The first which picture big question and question, is a Ashleigh. maybe is - it's for

I'm over. this bit will kind and to Like Just It you therapy? going progress like there - there's about a wrapped like, know you that to is fact of main just to head do think that autoantibodies so and things. be of up, standardized? challenge you the what needs had little the keeps kind past Or guess, front-running screening about getting forward But may curious you not of have be be the you very prep screening feel their that's feel launch on in of about how greater key hurdle what's it's you but when screening kind year do get degree a been a I talk it. of people's XX be today, just really that, you the over months has now the keeps the about And know the that you you've think just think to drug market? function around the - main to do very, to a we can that get people you that

Alethia, thanks for the question.

screening, patients I the line, to a to that spot not. It's we screening, on. use pioneering appreciate you're making and mentioned shift. that you starting to think say back finding and I teplizumab we're introduce So sure screening, you leverage potential paradigm leads that. the And perspective catalytically, we're that its But the

it community need teplizumab teplizumab, around the the forward mic on been We time, respects has in with with way pathway has the express for more and momentum prospect here the have making starting launch and first of a a to behind TXD. has way introduction unmet the rallied momentum. meant committee the advisory those potential disease-modifying had. that catalytic have on, will although had - the many during the meeting to community so the And that at-risk of approval respect potential the effect individuals, to a progress entire open had of it and hiatus the prospect we've in beyond and therapy really have would And than ecosystem regulatory line and following that the

I But we've change the initiated that So have more than doing to think give I'm a over is I away specifics. we of worrying work already sort with going to with some some been you about to rather of Jason hand what take personally JDRF.

accessible should impact awareness just speak But I more approved, effect. hope already identify Jason? to screening and stages. do But sponsorship ketoacidosis we helps, is certainly it to much And one. later able their get accomplished the to early attention fact something. doesn't gentle Even had brings an there. making we've the being Then appreciate before bringing diabetes, that disease type so more. and and the Jason a a of we if the to clinical can to and that therapy so anticipate will, more think if of TXDetect believe X we've you the it of diagnosis that populations diabetic symptoms stage

that think families spot prepare status know Alethia. is absolutely. that what there out that to like. are I think and and out want so dependence looks for to I adequately currently autoantibody we And they Ashleigh their the the insulin transition appropriately there question, know can for there right? Thanks Yes, on, patients

anxiety want and of are of that, coming. also know don't there are the absence a the knowing therapeutic We - intervention, what's that there families patients in out other

from to. the context a of data our acceptance drug research market highlights screening with of teplizumab both increase an as speaking of was patients highlighted approved nature I with intent Ashleigh you an and of XX% that the to some remarks, And screening prepared so catalytic saw that during in autoantibody that XX% physicians

therapeutic reluctant So screening they're it term, I and longer-term novel during in how the terms of in intervention were conversation a think the intervention to pediatric a of make teplizumab of routine forward. around individuals that the activates But well for. like problem that that the then that visits an States moving that United ultimately the care at-risk screening screened strategy, introduction the absence immunomodulatory we can in of our short standard address population-based be really in catalyzes

patient is And patients. very mention the potential especially has see prospect. humbly, groups to Because we good that, Jason? to brings community the change in I of kitchen that sponsored we circumstances. which their TXDetect, thrill, JDRF in want the we're to relatives that run a initiative you with the and by table Do opportunity, rallied the screening way grateful the think a advocacy that Working around the this is to this their so to bring excitement

Yes. and reminder for the thanks there. Ashleigh, Absolutely,

fact dry that Encouraging JDRF-run relevant. made in first important JDRF, - them the core which rolled the that three autoantibody program a autoantibody a the that already patient's and JDRF if lastly, through really $XX. the the comes think that their more much are for And with - that which affordability comes costs kit a this. And of highlight, for can't core the right? a COVID program in the I of is get I think year if care as it is that TXDetect blood technology component importantly, the And loved spot is on auto pandemic launched audience the critically that end $XX, most ones screened, be of all ago accessible possible home. The X blood JDRF through spot important. home out the community, $XX. that to type to The dry lancet being educational there allows of now think they constituent buy are own back to making down screening over a patient, height too in able then the will to $XX cost the that for component this during kit the your program to status. afford components as much a JDRF of to diagnosed So I complete this assess only comfort the and is of patient's program And to TXDetect linkage easy

at So of which a I think as accessible broader for a patient population kitchen patients. cost $XX, makes mentioned, Ashleigh of their table, a screened, be more to screening can that much

So I been the of we're think have novel founding incredibly program, it's and really with proud a to sponsors that JDRF.

lunch been - can the line, went your sorry, we finally Ashleigh, focus months. Yes. but That's XX storyline, kind pricing. that really accessibility and and kind shocking I the was to But follow-up yes, you cool. to have of ready it to with in your, past commercial. on guess of whole around is guys And with I now incredible the also, back just get in obviously, also in yes, actually

about, bit with to able little now Jason, a the cost. being just about cut talked You

do like some it the, patients? of of you screening. how the And these like I So kind mean think of know out-of-pocket kind about costs. there's I cost mean, to is And I

about? preventative get patients kind their like - have the - different thing? as kind administered is and as a do piece that different an you guys any there And to question you approach it's or are a are people, how you that think of I the of But when person to that Or of $XX. think like any in far of parents, guess, antibody then concern guess, to approach. kind treating patient it's maybe like sounds obviously, it And talking about just, is namely, treatment So see, using a how managing I children? other drug goes the the this other things

of question. you. to follow-up Jason, do want Thank both answer Great those? you

Yes.

absolutely, So Alethia.

at nuances we in how XX% care say unmet patients product talk after profile, of target provider's need, research product first a viewing the that are answer safety. of the and I'll you ultimately teplizumab quantitative that, product, around a once second see question the But accept maybe that recommendation. health the So obviously, need TPP, there after a questions the with what when to through treatment is, looking addresses intend

anticipated then number I But I in to designing support Medicaid to asking, we're is right? So respect you're final X% And of important mix think that - stages exactly XX% it's program, the other. think XX% note patient commercial, question with that that. payer the think still number about is that our then reflects I that and our

support what where can. our So commercial for will we patients costs we intent be to can to those do out-of-pocket

has excited about cells we're only their to forward give to of with of those the working combination insulin that excited And companies some with to and if Jason's emerging patient like response prospect one of and to the cell therapy, therapies we're combination with can their other from therapy, transplanted own, so XX-day with cell the transplant teplizumab prospect therapies on, so of that is respect BX the course first off part the a trading in going reasons of reboot them we therapy outcome for driving because good in protect to the on the very of hangs that options. can transplantation, a technology of immune that course a space balance. admire But be lifetime of system, a patient but relative a in that something we the restack lifetime potentially BX a that immune administer that therapy might suppression, keep potentially are to the transplant see is that discrete

you. Thank Awesome.

you, Thank Alethia.

back our turn session. concludes Palmer remarks. question-and-answer any Ashleigh for conference closing to This I the now like to would over

thanks Thank your on updated And progress you very thank questions, morning. you, throughout this and time Irene. forward for attention XXXX. all keeping to for much We look and all the again you our

attending The presentation. concluded. you conference Thank today's has now for

may disconnect. You now