Provention Bio (PRVB) 4 Nov 212021 Q3 Earnings call transcript

Good morning. My name is Sarah, and I will be your conference operator 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. [Operator Instructions]. this being that company's at advised request. be call recorded is the Please like call turn would to I now the over Mr. to Vice Doody, Bio. President Investor Relations Robert for of Provention

on you Thank and Financial all Provention Call. Bio's for Results you, Conference Third thank joining Operator, XXXX Quarter us

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

CRL, filings we represent Any the with and timing only. the begin, important various potential Form indicated SEC related include and from the comparability result and we in about the over financial a factors, the expectations, commercial report projections, let respect materially significant today me of may XX-Q, for we today as efficacy and including projected forward-looking of to forward-looking make our we and quality our and the our our prospects, future. for in and to same. that various constitute our and to filed you planned that resubmission as differ our impact Before business candidates, including Actual with COVID-XX the these the including including catalysts success make FDA other address with may clinical those any well those of most use including on for remarks candidates; teplizumab section teplizumab, of morning, statements remind our identified our statements Factors this plans PK studies anticipated and timelines in other of on SEC months; plans; forward-looking product cash safety, product views developments regulatory, teplizumab quarterly with runway; discussed will which results the cash and XX plan their statements. our other statements as work business Risk considerations, our clinical These product plans by in and the recent delivery potential potential of results, future and the as DLA next its to

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

Thank for by autoimmune and candidates approval our trial steps preparation week the then pertaining X update that our individuals. we will Type B our making you progress to with patients. of diabetes And at-risk efforts on announced company Phase We've delay X diseases. call as exciting will Bob, provide on the as teplizumab been interim updates potential of and launch in planned our last targeting an I commercialization relating made the discuss be to first-in-human on on provide well begin good in TXD and secure vaccine pipeline months. morning, considerable coxsackievirus the some polyvalent also potentially candidates, for teplizumab of regulatory data to next this few status today. serious you, and newly Francisco the other across the sharing has for past teplizumab. then will providing for team morning everyone Jason over diagnosed joining approval an our progress us activities the update pathway the PROTECT to of I’ll

before results updating issued will considerations you with in status the of Andy FDA we on received in financial the for letter noted up release July. In for our summarize our complete quarter, open we the call interactions press questions. we response a response this the past Lastly, your to the September,

Specifically, took to discuss August A part we and considerations a Type manufacturing. in in FDA related quality those to meeting product

from the addressed the in had yet the FDA either believe to amendments been items resubmitted. the by is release, the The by potentially findings issuance and the recent noted can been currently As prior We FDA completed confirm team the our by this inspection contract have fill/finish has or out not we noted expects CRL reviewed, expected. then as facility. of also have these to a closed CRL, time filed is BLA inspection a addressing press which at

patients FDA intention efficacy XX our ago. we in the in of these a seen remaining under is derived Given confirm PK through It comparable that sufficient product, years volunteers, is in curve commercialized teplizumab, healthy fractional to-be do study single the to of to not translate approvability to used Lilly prior concerns manufactured sub-study area our demonstrate provide this in factor for by with with data PK is progress, from both to Or therapeutically-dosed in produced clinical PK does data low-dose believe the our into material things. gating either difference that Eli patients. trials, drug from ability drug any

sub-study commercialized the actual this quarter we initiated material first the During receiving a Eli from samples collect either patients the trial source within of to the Lily PK/PD to-be PROTECT products. year, or

formally population Type the unblinding has submitted briefing XXX this second from FDA scheduled the of this meeting samples sub-study. agree of PROTECT of models the the of last collection The documents so AUC recommendation, can beginning remain prior the to the design to data PK the formal the At and patients, meeting half for FDA’s month, and month. collected on FDA following we requested A the completed a since from data. PK currently blinded approximately have We

regulatory meeting, September agreement populate A to also In Type the determine collected FDA path forward. PROTECT FDA's release, results, Assuming provided we we this from press and we pharmacodynamic the proceed sub-study. then with PK will unblinded data our receive the work the preliminary analyze the model, to the at

is receptor and that PD and consistent such similar relevant view products CDX T activation, manner. targeted the counts, occupancy, in both indicate drug cell cells a Our lymphocyte markers, as on T act remarkably

strong the do get our the clinically initial patients present they compatibility, cannot are teplizumab’s compatibility we to believe FDA to relevant. to Phase and While now this to may why rationale of differences use diagnosed goal in study was XXX PROTECT isolation PK claim six X weeks diagnosis. markers be for robustly determinative antibody, these in are of provide potential therapeutic newly within supportive enroll AUC we Switching TXD not patients, their for

accomplished families the sites. that patients clinical for I and XX%, report and now I'm to time indeed that importantly, pandemic but our the sufficient challenges guidance clinical acknowledge to we ensure want of we most And evaluable we do the three, August. patients exceed and have delighted given that to their has for study objective Our continued participation. industry, abundance end been completion has trial will applaud presented collaborators, our caution, thank trials this of to efforts some quarter an want team, COVID of Out the by PROTECT to patients. target in and at enrollment about investigators, target occur this the their we to would the enrolling of across

prior mid-XXXX. per deliver track topline As on the trial guidance, remain in we to results from

to our commercialization to turn discuss regulatory with the Jason you over has date remind gated to our like preparations planning carefully milestones. to approach call and risks I our and been Before I'd progress, and aligned that

moving and gain in number prudent we activities. to great on on this gating, Nevertheless, despite would and fronts, now. and make team been update As will begin able spending pre-launch we increase progress more clarity you Jason? like a Jason his of to we potentially on proprietary to confidence have forward, this

to has within when Thank with the of patient the approach on now. year an spend we've Beginning provide Ashleigh Ashleigh, taken, great access engagement, and on good you gated today, with context the progress to morning, we've the I'm all with for you, educate you excited speak as making been teplizumab engaging with clinical and a update data and to TXD respect our team been market and over hiring screening, requested, mentioned. payer everyone. payers

interest end XXX the of plan and than services. more our the prevalence of third lives million group and incidents of and of this of team Medicaid As our consist over commercial sites within had patient engaged The care, of representing model, areas TXD, distribution quarter, individual key the payers, payer segments. screening, across XX

the PDUFA in launch or concerns have these further new with to and payers engagement generally in expressed resubmission of CRL Importantly, any expressed a related have timing delay, a BLA interest not our date. event

has published white developed resources new recently team testing and paper a AJMC, on antibody payer-focused journal. a in general our education, auto including Additionally, TXD

coverage payer continue approval. and on feedback and strong ability believe We to need be messages making we pricing we those our with unmet quite meet and track progress We an teplizumab’s well, in quickly anticipate to and to has our across incredibly remain potential following for pricing place with and positive. policies, strong research to We're contracting that regard mix. respect our government been to date need, the resonate

quickly to contracts remain in upon possible as model track approval. to distribution we as with Our established, be key has been teplizumab ready place, distribute and on

and Additionally, market the have services contracted endocrinologists, We’ve track along to more stakeholder perspective, alike, a caregivers. been our PAs, patients, partners than with patient a and strategy. of From X,XXX selected relatives designed endocrinologists, from as our to readiness. as patient marketing for pediatricians, needs research NPs with multiple and participants to healthcare launch their program families patients The caregivers, well date, input from meet with extensive key are and this audiences, providers. insights across including physicians including stakeholders, go-to-market services has designed gleaned and key pediatric research on offering TXD with conducted adult informed deliver we've and

we awareness launched late As campaigns disease in two XXXX. you may recall,

has significantly notably, for has this traffic, the in X website, third year. has and Type tested seen consumer Our quarter traffic which its amplified the national significant of received recognition content,

connected our exceeding of provider website time healthcare are by on along with of site. the Additionally, traffic, amount the in terms is also expectations, our TXD, spending visitors both

the has pipeline. the going Francisco? made pass been share I'm team has and Overall, and education, to very profiling which progress key pilot our accounts focused we with updates small customers, be today. for on to force disease toward to to the now readiness, on you I'm data, an I'm as deployed the update recruited, trained, team, well state across on launch providing the Bio Lastly, that pleased key Francisco with and PRV-XXX able over happy Provention introducing sales further call as country. a to

Jason. you, am our updates Thank join regarding discuss the today to autoimmune pleased to I pipeline. very disease-focused you

Let PREVENT PRV-XXX, discussing morbidity, us TXD of all study targets first begin not pericarditis, the our the common autoimmunity. candidate, associated vaccine inactivated study, as otitis, a acute a B topline and polyvalent of hand-foot-mouth from which results with meningitis, just is key coxsackievirus myocarditis, disease. strains CVB cause such CVB five in-human exciting first

weeks of In many addition, conducted in four-week half disease been results a participants PRV-XXX An treatment-emergent administrations conducted, associated met we development is well of trial leading being chronic placebo-controlled who to in trial drug is with follow-up no of double-blind or it interim no the tolerated it’s be we diseases. the events, interest, special study follow-up celiac was of no to study infection provided in of of administered. in this after volunteers four concept and randomized additional two-dose and month, demonstrating autoimmune healthy first in primary escape, these last study, adverse endpoint, interspinous events adverse trigger the study intervals. analysis three off completed interim that events adult had cells, of the after levels discontinuation believed strongly The patients, PREVENT which sets provided is immune all first-in-human the and the adverse with and were led of third pancreatic was expect PRV-XXX a TXD next to that and In serious withdrawal. dose year. the the final six-month results

percentage induced The arm negative responded increase baseline and low-dose dose-dependent in the or vaccine, exciting high for was from for of seroconversion Response global titers results viral-neutralizing subjects. and X% trial, a Importantly, potential serotypes, as five and the predefined PRV-XXX high-dose Xx to PRV-XXX. in now incredibly XX% in partnering ultimately subjects, was placebo, baseline-positive also both antibodies next the celiac in program. a to it who the complications, a as subjects vaccine we've of met program. has are its the endpoint, far contribute against step advance serotypes in to all to the XXX% help first the complete the of incidence potential secondary disease. for believe as CVB all titers Overall, to TXD to fashion. from seen in arm, decrease and included the a of this the many the The steps significant PRV-XXX infection prevent and we vaccine are be ever to We this of discussions follow-up forward engage us and CBV so PRV-XXX, in right efficacy the

other our pipeline. Moving key programs in to now

gluten-free partnered disease. with diet begin Amgen, First, which let been human for of antibody, celiac non-responsive the developed is and monoclonal with treatment fully has us PRV-XXX, our anti-interleukin-XX

XXXX XXX target of celiac patients. As August we trial adult in a with of initiated recruitment this

to impact in having is timeline. forward While we the COVID-XX, an managed now despite our push pandemic

In we trials, many to celiac-specific impacting which also COVID-XX-related to which encountered our general our according intelligence. as delays worldwide, to are competitive well factors, trials addition led have disruptions, all study celiac have as in

of reduced exposure travel non-life include diseases, out during people's of shutdowns gluten to endoscopy related lack prioritization threatening chronic to pandemic. the examples these procedures, elective in dining of Some and reduction in factors and of

several to closely normal that working improve and also strategic more to investigators sites, conditions. implementing begins resume the continue with world And believe operating are we We as conditions and our activities. will

timelines will we the the trial, the in the the for treatment first enrollment has and XXXX. We have However, are complete this with and we at disease. approved this potential that results our expectation PRV-XXX believe drug topline to time, adjusting become guidance of for celiac ever

including is to on a touch scaffold of like autoantibody would program, which take to inhibition trigger PRV-XXXX, depleting B-cell DART, designed production and PREVAIL CDXXB, CDXXB I to of bispecific the the suppression both function, moment targeting our developing without Lastly, B-cells. humanized

terms the in study, track systemic trial results exciting initiation look As X on prevention-of-relapse, trial. in now fourth on of the erythematosus, long-lasting are in back year. study proof-of-concept call over the and we B-cell the in inhibition of now screening XX-week a Xa is trial. initiate saw positive this program more to we Phase lupus quarter Xb to I Ashleigh. details the we the PREVAIL turn sharing forward in this The will of once We announce to Phase

with Thank you, Jason, those and Francisco, for providing updates. us

taken have of into our will we noted Financial results, financial the be press retiring release the this Before you a from will move issued as separate end Chief morning, Drechsler, Officer, Andy his at by this look year. December, in and we role be you to will And all this Thierry will arrival. introducing Thierry who us joining to upon forward Chauche, forward be

face. patients discussed made impact at Andy. can emphasizing way recognize has lasting Andy, board this I personal diseases world we and Andy promising to he their my member in interactions profound so you friend in burdens us associated to your autoimmune to time devote every more with in many the role the a what and time for and family, have close bringing TXD so Provention, closely speak own close the your to work and possible today, all have well fortune for with colleague, We all, through his to colleagues Andy? Andy and your unreservedly his and we in the has opportunity challenges always had as good a a and fortunate contribution family, benefited advocacy has spend family the from serious However, beyond lens. personal you the wish In good retirement, to families. so, crucial of the has considerably were you, and TXD so our Bio within leadership of us you he to played and disease with more feel and Provention doing see and as allowed can and celiac mission. precious stage. Andy, being that happiness to they health

people, that to to rewarding the family. I in incredibly individuals been executive entire team so I'm forward A Provention. so passionate the the assisting next we've colleagues be that worked to Ashleigh. many helping pipeline the committed sector. my will work both in for no doubt to Thierry strategic in fit proud in at thanks we also past has is community commercial team. years the biotech to board, and I special over of Provention I to conquering in organization And you that our built. successful for quite a an guide to the on investment thank you those It of including relationships Thank team, his is diseases affect stage very and all we also transition, built, as my am looking our of and the XX team have financial of the the his growth. experience, he developed I have want perfect

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

XXXX. The and significant a costs, production drug of loss in decrease the supply share. per Let drug $XX.X million in million quarter third GMP This per with loss XXXX decrease in incurred for for is as of $XX me net net a share compares of P&L. and the or and of product diluted generated start to a teplizumab of batches attributable or basic the loss we third period net costs basic $X.XX and PPQ manufacturing XXXX. primarily same with quarter $X.XX diluted we of during the

were incurred BLA teplizumab which the and development disease. related PROTECT activities initial trial, year the costs, a development celiac cash. flat, by X $X.X research expenses in pre-commercial in reduction decrease as Shifting by offset costs increased PRV-XXX related in prior our the the expenses, clinical million We teplizumab primarily in also now the in to infrastructure July. FDA submission. issued relatively an offset and a in to study were regulatory in the saw G&A corporate The following decrease were by CRL in was pre-commercial costs increase expenses, Phase decrease a for to proactive

was position XXXX, As cash million. of September XX, our $XXX.X

which exclude and operating net XX, stock-based ended for expenses, Our expense million third quarter September the XXXX. were cash-based $XX.X non-cash depreciation, compensation for

million to of for operations expect We use of in between $XX XXXX. million $XX and fourth cash the quarter

We provide current of and cash, securities, operating the that, we each closing his for our our continue to expect at guidance to marketable next turn develop all be equivalents, potential to commercial requirements that call, will of towards additional to fund With four quarterly least let plan cash progress We and programs. approval XX Ashleigh as comments. months, call to over and will cash actively the us for clinical enable the regulatory projected me launch teplizumab. on sufficient

Ashleigh?

Andy. you, Thank

we the call make remarks. to few a want I questions, Before up closing open for

devastating advanced approach the to diseases, Provention, providing the to or therapeutic for and months creating and acquire delayed, can pipelines. of vision, strength advance dedicated be the sharing final founding and thank a our paradigm our back intercepted, and shared prevented. the vision investors in we which about build want of I to As acknowledge a consequences XXXX, of financial serious and think our new autoimmune the exciting I stages to I Francisco company

approaches I only colleagues working also now drug would Provention, overcome thank unmet autoimmune our take in share and acknowledge on vision, reducing of are with our the come not the of potential to first who the pioneering challenges and but the and way the like new approval. to enormous courage at disease. need We hurdles remaining burden to also that to socioeconomic our dedication

that also provided yet required. have review working all us. with teplizumab challenges committed unprecedented the you of the We appreciate to care in with and BLA We the remained and dealt Provention members of COVID, alongside attention who teplizumab face the recognize FDA and team,

the autoimmune that us plight at like all provides and appreciate diseases. Operator, family we It consideration. of and your that, forefront that With by questions. purpose, serious so every deeply our is members to caregivers, patients, always take of our we'd any with Lastly, is affected the

Thank you. Instructions]. [Operator

with Our Please first comes ahead. Cantor. question Young Alethia go from

and scenario over more upcoming, I scenarios. on help Hey up. you then about know and won't about set great events that you're next have thinking guys. six question, it, you talk And scenarios the can you for program? One but on be conversation different another the some analysis, you the the have thinking until like talk final coming Two bit you. outcomes taking Thank a know the how months my you potentially obviously I questions, on ultimately some wishing just Thanks steps little congrats can on you and planning maybe the know all of for must us for data you Andy, best. and about and guess. this a obviously about PRV-XXX, next that teplizumab, FDA the kind understand of I - but analyzing like maybe of kind for different that's study career,

very Thanks for Alethia, question. your much,

taking the a FDA So, interactions step one time. at we’re

meeting, the meeting with model, the of have FDA. analyze November. we the After next A populate half I we appropriate the second that mentioned, immediately As and the the discuss will in Type steps data,

supportive also we PD previously, for out robust, set comments press this the very and in the think we As data morning with markers. in that strong, I have my release this, parallel

And consideration. so, to we're address very this that believe CRL we robust a proposition assembling remaining

planning for success. We’re

the maintain from with all point. you really arguments, That’s supports and anticipated resubmit at that intent it's launch. earliest to submit data momentum at if or our this BLA these an forward move opportunity, heard to As the Jason, the - respect the our and

We’re considering.

that want that not I we to is beyond do. think to something speculate

consideration not the all an very we've ultimately support and confident for the that the that FDA, said We will what but data clinically important are it’s is along, that relevant. arguments comparability the

XXX? then And

next the the you could steps in program? explain PRV-XXX Francisco,

Alethia. morning, Good

broadly then potential exciting the share more a forward. going to that the partners of program we us and of this conferences, data, are with the details couple community incredibly on help the forthcoming heels move engage scientific at So, will

Our is next towards advance also the target pediatric conduct as of that immunogenicity the to ultimate steps proof-of-concept are children, in of and study, focus vaccine. and a safety study, the which

Thanks. sense. makes that Okay,

comes ahead. Markets. Renza Our Please RBC question with Gregory go Capital from next

Good morning, question, and Andy. well-wishes team. pleasure add taking also Ashleigh leg for the post with a It Thank work you and and Andy Provention. to you, congratulations my my was to next on me let

following bit those you about up just A Ashleigh, outcomes on just as for your could on to his Type that plan as maybe the question become and the you're then Jason, build as you. previous views elaborate question, clearer commentary. if following meeting, secondly, to a just well wondering how disclosure the sharing Provention’s a on thinking And experience, from

on maybe little if the momentum the about comment issue. has an bit that, you post outcome, to the think shared manufacturing been for maintaining three-year the as the how focus of as BLA on preparing just And that flight wondering follow-up submission. Just we you to positive you inclusion the with in you're a eventual much. how the Thank was could very related that are would with initial respect refiling, stakeholders data

and Greg, morning. good Thanks,

So, with to room leave the interact we ourselves want to FDA. properly

the making A the be receive outcome disclosure that anticipate we regarding of we meeting we Type after So, a minutes. the will

accurate. So, assessment we that that is can make meeting sure our of

do data, you from begin meeting, on immediately, to A momentum? the model, and feedback disclosure be prudent perspective, we'll want analysis. do from the run be Type that to a the indeed based to may to that hopefully so obviously the speak maintaining Jason, whilst unblind working the However,

absolutely. Yes,

a continue have I Greg, to the We've our course And here, campaigns the over we to market. lot that little we've a half a work year in time frankly, did foundation. and awareness bit done the a of two-disease past because able out right? the lay momentum, of think, got we're lead of

field. targeting. strategy continuing We’re our execute out We've refined because on in and the and our those. have very months team supplement And that's five I increase that traffic healthcare of pilot non-personal sizable sites direct those screening, to and momentum engaging a conversations personal a seen over there six media of pretty lot We've tactics. in limited given got of to with impressions or and promotion be to on the that's last awareness think professionals have disease able us the to

around important. the personal the and think we against, really screening the really both us is fact And momentum disease has So, I and awareness, I needed allowed continue channels think have in non-personal that education level that field. to executing of we're that

great. And three-year resubmissions for FDA? just inclusion on and much. data the potential you That's the Thank very comment to

you I'm repeat sorry. Could the question?

Yes, sure.

far as Just as that year. follow-up shared was years last the teplizumab data three at

if FDA. part of curious the the part that's the Just to to package will be resubmit - of

Francisco, what I'm want talk about do you to that? not referring to there. quite sure data Greg is

data sub-study? PROTECT pharmacokinetic our in to referred you the Greg,

it that was with submission the the last just to filing. be XXXX BLA shared. Referring I Francisco. close year of data was recall to too the Sorry, part ADA initial

The TN-XX Right. Study.

to request issues has data. on of yes, Francisco, safety an remember, all. at provide safety we'll CRL. no, So, But this respect or CRL with efficacy is That update a - that no not was the

we with we data for And put forward can the strongest best labeling. to soon will so, our But arguments possibly as as PK the address best and goal the comparability resubmit this consideration, is possible. remaining

you. Thank Great.

go Our SVB comes ahead. Leerink. question with from Smith next Please Thomas

would could or update PK sub-study data PK/PD half to update the of results morning. the perhaps me of It that from data have thinking you earlier guess, timing Or up an about Good actually December. one how and once think shortly guys. from the my sub-study? best the in the taking we next concurrent be either like meeting FDA the be his with just I analysis. and add congrats the questions, to updates provide follow sounds on and you're chapter. Thanks questions, I for from see, to Hey second interactions guess, it should that about seeing which to the presumably PK cadence Andy for the thereafter? timing Is minutes, wishes to planning on reasonable let we topline results and thinking regulatory the

That's we based but the up-to-date and an present make sure unreasonable to that picture again, not FDA accurate interactions. want on we assumption, most

a And be We Type and believe take the that. will approval and is yet complete soon here as that the forward to A result hope the the results can't a place from speculate again, in as FDA that model possible and approval. FDA's order and BLA from meeting a is potential believe addressed a we the to - of be able report step needs the time. to that methodology robust then with everything we're initiate consideration the what sure topline move manner, at do and analysis our so, going resubmit it because very straightforward take to in. make the and be perspective, will one in it perspective, But this We to remaining that of we we

And clinical at-risk comparability, date they And that, could to focused in got perhaps Europe. going related update anything Okay, how data included more submission your with to the potential or to you population? on just it. are and provide are thinking on follow-up Europe, EMA just have about if to the the a then and was conversations the conversations you're wondering then turning an how PK/PD

Yes.

that disclosed ILAP the So, in UK. discussions advancing with initial and we've we XX-Q today, the had the are process

of FDA's the forward addressed. in consideration regulatory assessment. the the that comparability the that a indicated agency the to best can to that to I United until to we the an we it's comparability the able aligned And the past address consideration outside is States file MAA of because to post-Brexit, next for that, issue throughout to more path momentum can further then first the we're that with UK UK We're we've likely maintain from satisfaction, tends your be filing the second and point, PK be properly targeting planning the that next be we And half think EMA assuming FDA address the year, of be assumes will authorities. all in year. in engagement with think

it. Got

chapter. next Andy best again, to the makes Ashleigh, and the That Okay. sense. Thanks, updates, for the color wishes and on

question Wainwright. comes Raghuram from with Selvaraju go next Please Our H.C. ahead.

taking so Thanks much my for questions.

the with very FDA. respect the with a quick just to one Ashleigh, interactions

of wanted addressed that likely to all were meetings, definitive CRL original data, items the be raised the a whether addressed. being or clarify in anticipate upcoming FDA that to have that either pathway pertain compatibility Just out you don't to conclusively coming are other the to

Yes.

a are you meeting the not for address CMC allowed issues they and So, and review issues or with we prior a we make with. been have addressed those thank reviewed. on, see we that so and the and and is comparability that Type that remaining routine August to to is There’s addressed obviously the because CRL to obviously, meeting them, we PK they're studies, to study data are to BLA we because It in consideration the has us update agency, it It's back the really requested And to update, to outstanding the CRL which We not not any continued available had issues, to And on have safety not BLA been they want A an all prudently therefore, as point. And safety. to the believe, a when be addressable sure on there your to the we the is will the the teplizumab, BLA wants a filed our approvability that The had path that's this it is where the make PROTECT status to manufacturing resubmission. comply agency, point, by they with had safety Type from were data the also already critical receive that. of - the concerns statement in request, resubmission. obstacle that over and the it the last that to period - submitting. confident plans that and patients question, submissions able quality overcome Ram. address product any to A

which in actually Okay, look perfect. what were with discussions the any FDA, you the discussing had And other then are at earlier Have data. regulators, regulator compatibility than just following PK you substantive the from likely beyond the way way the so, it? read other regulators to on other likely topics other are originally how FDA relative if countries the treat in issue on raised? that similarly the treated to concern what's of regarding FDA FDA the to this the And your has regarding specific

the up. follow you Thank for Yes.

consideration than of else comparability is the We’ve application as other issue a anywhere not review a application. market submitting result States. United market So, a a submitted in the

unmet And data, clinical on and substantive specific forward trials, with a the advice the that at advice receiving the looking of conversations been authorization so, scientific put to totality the how the conversations, application. EMA we've the had with need, and the UK marketing have

the in so, we consideration not very having from PK I they is actual the consideration. PK discussions over on see it doses no period, therefore of receiving substantive United seen likelihood it's those the a outside same or the agencies States Nevertheless, likely have will if And be therapeutic comparability XX-day patients XX the will there FDA's the satisfied that way. the of view, think point that agencies with had

That's Okay, thank you. helpful.

Just his to on questions a The best upcoming extend are few as financial questions. Also retirement. wishes my to wanted follows. Andy

driven accounting due the break I a questions of looking Firstly, us the was us and reported show then of how those as was Thanks. first accounting-related. that the down then dependable second that purely you is just likely the you for in reporting especially G&A can expenses quarterly quarter, the revenue two expect quarters. are consider MacroGenics go-forward And you to the be quarterly a to precisely more and of quarters. amounts the of in basis, quarter, substantially the the what with spend quarter, kind what respect on And us considerations. third by amortization-based respect a was reported reported kind line, whether on to were third you have G&A for today to P&L? that on relative at And milestone you next sense treating to be the up the upcoming I that would of the for in give be that to that likely to teplizumab, be will amounts, and how can just the perspective, for understand the wondering from on it seem declined just to reported that's With third baseline an approval

Andy?

I the the and questions well wishes. Ram. appreciate Good morning. Thanks, Yes.

and just was, spend, a we So, up we to pullback we in QX that year. on that provided reduction ramp saw think amortization were guidance to quarter received the is saw $XX upfront Huadong, a I burn would operating reined be the the monies right, and you fourth put right, to of reasonable we only expect frankly, we've in. QX, that money, right, Once the in the obviously level quarter. Ram, in the rough this were expenses, a starting of in From the But that beginning, it's the that's forward, milestone what the million of f yes, the million right, same what CRL, $XX the pre-commercial money. you - in G&A, perspective, those quite first was by half revenue

soon that of that any around amount We and will end take MacroGenics, up approval recognized is recognizing the or would detailed a be after recognize revenue. So, the offline Phase calculations conducted, approval, next years, over right? on are we'll that study as finally, the And full to the for that. conversation occurs. of that activities X milestone then lupus payment paid couple there upon Happy of

about I within paid think days. it's XX

Thank you.

from question go with David Hoang SMBC. ahead. next Our comes Please

Hey, thanks so much for taking my questions.

manage could just one sounds if on for Jason. the granularity you've the I'm wondering things product, authorization, going like up. but really more color, any had with payers. discussions wondering those first one think that a been So, probably you has the share little I'm they will come restrictions, like bit is that more just prior if what It well, the type I if have of how

Jason?

David. Thanks, Yes.

sentiment. agree your with I So,

encouraged consistency for feedback a that think year the I and our of expectation been feedback a we've and and quality prior have goal feedback, authorization the say the our is from to label. both I of payers, half. past the would streamlined the strategically the receiving by frankly, I'm that to

we've I that label, see plans, medical we as that's heard be set covering assuming covering is this, what they from and egregious, price anticipate under think that to that a how would they that they the would haven't would covered don't price benefit most as it and anticipate the payers something yet. likely

the So, coverage anticipate is I streamlined would PA to and anticipated we have label. that goal a broad

it. then vaccine had the that. Got a really I just candidate. Thanks couple helpful. And questions That’s for PRV-XXX, on

of study, X reading to really a the partner I'm Phase have sounds to efficacy forward. if it would that this be the products stage correctly, for So, like you kind in advance next is wanting

the is correct So, And read potential also not make just you've similarly, want for mentioned also disease. sure but then to case my TXD, use celiac there. only

there celiac. if to are this wondering time for I'm at develop So, it plans any

Yes, thanks a lot.

and the advanced allow the good in a that by you're has and ultimate stages it asset partnering yes, enormous is that So, have think will company vaccine that think and think correctly. generate. polyvalent I showing that expertise we by because we is better this created commercialization, are good us and a company, handled the conducting that to very reading mechanistic handle proof-of-concept discussions, of believe, value to immunogenicity vaccine the not vaccine we We a experience. development, we've And able this, first study this in-human is

you, thanks to Well, and luck taking next for good great. question, Okay, chapter. your my in Andy,

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

for going on to happy we your you holiday thank approach as again to Well, keep and to we'd that up season you time like and time. this attention forward We a you families, continuing to Thank very progress forward, your all and healthy look morning. much. of you our and wish date

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

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