- Earnings call transcript Q3 2022

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Operator

Hello, and thank you for standing by. Welcome to the Q3 2022 Apellis Pharmaceuticals Earnings Conference Call. [Operator Instructions] I would now like to hand the conference over to your speaker, Meredith Kaya, Senior Vice President of Investor Relations and Strategic Finance. Please go ahead.

Meredith Kaya

Good afternoon, and thank you for joining us to discuss Apellis’ third quarter 2020 financial results. call and the Dr. Executive on me are Chief Co-Founder Officer, With Francois, Townsend, Adam Commercial Medical Cedric Officer, Chief Chief Officer, Dr. Chief Federico and Financial Sullivan. Tim Grossi; Officer,

in Before risk certain our differ you current SEC that additional and point results our beliefs. forward-looking we may are like materially. factors uncertainties, expectations that will to detail. subject and statements to actual statements on be encourage making and for consult begin, out based are discussed These would risks the I I filings we to our

Now I’ll over to Cedric. turn the call

Cedric Francois

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

Let in and with which me XXXX. NDA, call is new OAKS by FDA. This Studies is the be XX-month what now, to of timeline X decision months from on the to a the submit the all start February to this will major amendment our efficacy extending expected submission right DERBY our considered revenue III minds our a data with Phase PDUFA

effect Let we this me have is these about by studies pegcetacoplan decision over not do month profile data was was of time. full they The with at launch effect with inclusion to decided both other clear the in educate respectively, why month every showed resulted gives of at effects update. just and that XXX-day XX-month label combined sizes and and XX these part to GA to every the with the in monthly had have over Remember, us patients the efficacy questions many requested progression XX, we safety XX% of including This state this impact of this XX%, The better pegcetacoplan received slowing the reason treatment and monthly Between months increasing meaningful ours. so because XX launch treatment. with data upfront, a FDA. the the treatment around as timing. best robust other the would minimal message already physicians product with period. that months, opportunity our and Recall data allow to us X-year as the additional of

Importantly, more profile we the were the than patients data discussing in between efficacy meaning X,XXX spend X see the them. safety can XX,XXX injections. month to remarkably the DERBY and over time that studies And of OAKS, between at XX, a we continue differences nearly with favorable rather consistent

of let of date. this August, were how Now unusual talk were, our we time given strong file code now, we me we timing as recognized the to top-line major At permanent discussion the would we of did because close decided the readout internally XX-month PDUFA that our data we believe original our timing about appears by launch how in why had against a and it X months. would We which whether to it given the delayed the amendment. J we our

be European We did PDUFA not package data the the XX-month without compromising expect completed to filing also before deadlines. the

first of launch track EU There best in to of data and the RGA patients with on to extended strategy we submit FDA we waiting The best with is factors also impact this not combination patients impact that authorization XX-month decision to also to launch possible December year. had take start our decision our The of would RGA prepare X-week would the to period significant which of our completion need application suppressed without we is in than deliver decision factors PDUFA delaying us European marketing expected, the GA data happened we this treatment, bring given no continued in but remain made to at XX-month end that The logistics, and fastest understand this January, and lightly. as putting data. for the right supply the approval our of [ph] into meant only the receive the for the We position product of some our the to is changed. to October. a a medical these timing overall RGA Also, code this meant However, around believe launch, patients. is already as to world. delay prior we and label is U.S. get We physicians this strongly review to and with changes we submit this that package the decision. these game the and profile did be finalizing filing. the our are data pegcetacoplan and way on the disease in to aligned plan The faster It to MAA to label. coverage the a by a the is holidays, year the step our submit that unmet in the commercial

with third the Turning launch business. partner, is also Sobi, bringing on progress sales of our second Aspaveli quarter. continues well PNH. rest Globally, the now to product year pre-COVID of to U.S. in market its million $XX.X The in the EMPAVELI making to in progress the

a turn our therapy including as Beyond And and our our gene both Beam PNH, to internal with that, And continue to diseases. and collaboration we therapy it continue conditions. will complement-driven over products advance I programs to Adam. with for transformative AAV-based rare neurodegenerative advance. pipeline, early-stage EMPAVELI other

Adam Townsend

we their on at in for I perceptions you, is meeting. these last direct the a our conversation at minimal with with delay, document conversation think have data was and these most the became having a plans the launch impactful been that will by of week decision. more the launch. label market of in them research right recent have In data receiving physician, application excited Retina as more Having GA. patients. Based very they that with the meaningful allows to Cedric. clear feedback using data the Thank can Physician broadens the launch, in the XX-month have the potential it With team Society in strong. commercial including as have. label recently both the and The label how is pegcetacoplan important start you a XX-month been pegcetacoplan to any us allows the about included has data

We disease have approximately through commercial engaging medical teams XXX currently awareness specialists, build and with to GA and urgency people around sense across working our of treatment retina education. state a

small education within motivated expertise I state disease in bring this incredibly launching team to are and market. bring the of continue with come and therapy retina. first will our They only who the GA approval. am impressed large talent until from companies significant both drugs the and new to expanded We

continued among current Now let forms, to to the me receiving high payers. our key this million see turn strong and third rates, sales quarter. for top product, positive net access the REMS the indicators certification, third across resulted physicians trends compliance patient This population, XX in $XX.X for the continued quarter, patient EMPAVELI. additional we leading XX In XX including in stack commercial approximately U.S. product

mentioned broader every benefit have focus could positioning treatment who market, call, as As further we community adult following first the for PNH the year in EMPAVELI's first-line EMPAVELI last by from it. to expanded with our quarterly living on PNH the

force a We members. areas brought of to list professionals III X and of we the our If the team second now quarter who with our for PDUFA data safety efficiently team structure, in date partnerships such, patients. Phase greater the us PRINCE a results healthcare data. awareness launch. with and September, our addition fully efficacy XX-week EMPAVELI patients we As the field of III so expanded of treatment-naive phase refined community. they field PEGASUS full can together new the allow our the Phase the during will We and as majority We to in of are the approved Separately, call on realized further and we further the target key the field raise in this that our XXXX. key sNDA our for promotion has treating long-term focus are including and strengthen reminder, prescribers on evolved centers, PNH with engaging February PNH our FDA, by deployed

turn to the me call over Let Fede. now

Federico Grossi

In multiple been and growth the data engaging to initial showed with in has the been in patients at longer-term pegcetacoplan very share greater them across With opportunity increased over monthly and that past well results month XX. afternoon, Then to data benefit reductions month data highly observed of few arms, has acceleration Results from with the between renting the months. increasing could on XX-month XX treatment label and you and consistent potential the both if substantial. team with Like Thanks, of ophthalmology be combined specifically Adam magnitude Adam. DERBY our and an effects every XX. in were congresses said, at been the demonstrating feedback invision this other in in to of possibility these received. outstanding, These everyone. growth, pegcetacoplan monthly treatment resulted at look over XX% reductions has we the the time XX% medical every-month OAKS, announced showed launch arms. with of and studies treatment month in X reduction respectively, pegcetacoplan effects for from baseline Good hundreds months four this had XX August, the specialists the and The [ph]. having

same period, equally pegcetacoplan subfoveal to arms. XX-month be both effective XX- also the treatment lesions both to Within in across and non-subfoveal appeared

data we years with nearly at X XX Safety months. safety favorable collected injections. to has see over and X,XXX saw we a XX been patients now Importantly, and what over continue XX,XXX in consistent profile

pipeline. to briefly systemic Turning our

October, announced the the our are diseases. We in III results X in Apellis registrational to later-stage in the CAD. Phase or to first includes the the Phase pegcetacoplan in of dosing patients. are in top-line to finally, on ALS EMPAVELI, on track our HSTC-TMA partner disease both studies patient rolling n franchise with remain II multiple study X IC-MPGN disease agglutinin platform And and broad report we In and first from CXG complement-driven which Phase its study advance study in of potentially II study continuing A mid-XXXX. cold our Sobi in deliver

Let the financials. me review Tim now turn the call to for over Tim? a of

Timothy Sullivan

summarized highlights here. issued XXXX full will the today results, with we just the a Since third earlier Fede. release you, press the financial Thank focus quarter on for I

consisted expenses see, $XX.X which R&D million As million, revenue and and revenue G&A million, Sobi. million. in in and net revenue you net can EMPAVELI reported of million were $XX.X million a expenses $XX.X product $XXX.X $XX.X loss from total were $X.X collaboration of was we

the the including XXth, now short-term current EMPAVELI, And our our potential expect of into with remain that, cash in to launch global our in cash, and pipeline. in execute financial in launch September closing of operations and upcoming GA pegcetacoplan future with XXXX, Apellis ongoing marketable turn We for continue shift I to continue $XXX.X milestones. balance the cash of confident equivalents, this securities. will our to as further we we Cedric? development Even on launch of first call quarter As had XXXX, Cedric remarks. the back of over Apellis’ million timing, fund to

Cedric Francois

This company. Thank you, important Tim. our is for time incredibly an

in the expanding. market position PNH Our is

believe as pipeline, We we programs have and well encompassing into continue rare that late-stage are advance close a to people's having we disease clinic. lives, on life-changing heading a programs preclinical the robust to a second impact commercial available as product can multiple

the track call global leader And compliment. being the We for are achieving our open Operator? us to let vision in questions. on now of

Operator

Sachs. Goldman of Kumar Madhu Instructions] [Operator

Unidentified Analyst

This is Rob for Madhu. on

First, what's PDUFA should necessary? wait Natomas the submitting we [ph] frame after how still expect XX-month clarity the submission, long and for the the And the to to date if FDA? on data time for

Cedric Francois

you question. much, Thank so for Rob, that

with would new that in current discussions FDA, or as classified in that is the this be latter PDUFA would the we February. the date our if We in this submitted -- we PDUFA before submission of that sometime amendment. FDA an was again, part with unsolicited So agreed the get

where that we So step. is currently

Operator

comes question next from Tazeen Ahmad Our of BAML.

Tazeen Ahmad

since the wondering talk of gotten put I attended feedback this the to that you Society, might Cedric, the I about have press that you it weekend. for release if know you was any share in time meeting out Retina could there. was you

XX-month physicians pushed does Just for expect wondering February, have J-code label. you data launch? you to your then And get that we what secondly, to mentioned PDUFA applying when J-code, permanent reaction the got if in when you the you when to the would from date should see be now

Cedric Francois

Thank you, Tazeen.

can will elaborate patients. And physicians I me and benefit doctors, to you On the maybe over as with from who feedback for but Federico, the there a hand Fede, And well, again, are was it of doing overwhelmingly it little we this was the positive. bit.

Federico Grossi

we week like it’s with. Yes. at the the was our over atrophy, start valuable, that, very to the and effects with data possibility understanding physicians in all welcome months disease, having feedback and understand positive and having of highly time, The our this and this geographic label decision really XX

Cedric Francois

And then Tazeen, for question, the on J-code. your second

So we code early expect J to October. have the

Operator

Evercore. of Miller Jon

Jon Miller

as primary the for statistically does now? were data time? wasn’t designed the a with as given XX-month yet mentioned question. And treating XX so, impacted agency Have have the you had data that I FDA prespecified in primary. the FDA? treat at primary Do the months trial just how And anticipate would is as being trials data? instead that previously, months later you was if how XX you secondly, by discussions the And work been labelling XX months that then

Cedric Francois

you so much, Thank Jon.

preempted amendment with the discussions on this our So FDA. label the discussions

about again, a the that. it was endpoint. as be productive it So to very to But relates interaction primary clear back-and-forth

will we course, course, this the had that based to decision -- on from have before, the agency. But is, that we we the apply. language something So mean, I see that's, may of hope indeed of

Jon Miller

bring I asked between of FDA earlier data. another in ever obviously, because, questions that the data your any is understand. did around up difference XX-month Separately, I discussions, important and the XX microperimetry

Cedric Francois

you, Thank Yes. Jon.

excited So signal can size microperimetry FDA as anatomically consideration for clear, of to was the looking at be the these may patients. around had very treatment. primary reduce of functional the But showing lesion the impact we every the endpoint lesion in be growth to about, actual were where a we recall, that the we a the continues efficacy and and with you

Operator

of JPMorgan. Rama Anupam

Anupam Rama

on call. I the asked thought PNH this maybe one I’d that get throw question might

EMPAVELI, of is PNH curve On therapy. the phenotype the about ramp the -- patient might data the naïve wondering the that what PRINCE suggests study your from just those market that how for the SNDA research change and initiate treatment patient might including

Cedric Francois

one over going Thanks, I'm that to Anupam. hand to Adam.

Adam Townsend

yes. Thanks,

team obviously, EMPAVELI the Phase the is on with the thrilled we into as go progress So launch II.

the III patients physicians just of NDA benefit EMPAVELI. Phase allows PRINCE conversations switching the even supplemental with about have to the robust treatment-I to data and So more the with us

will treatment-I have XX% people patients. expect us allow about our and EMPAVELI we much to So a we update at product label of the detailed moment, And the actually more remind is that that of conversation patients are the having on the choice.

and is super that some So potentially in think really the to I there. field-based label, we’ll strong see team have the excited progress

Operator

Philip Nadeau of Cowen.

Philip Nadeau

In is we action just broaden way you you filing ways in that is the XX-month what data FDA? question labelling have how pegcetacoplan And the One on where get during elements the first question. data from all change that? didn’t the XX-month label think a time, proposed you you any the question, in use could any like. That’s some weren’t know the on there seen pegcetacoplan. drug? would are prepared said you in then to the that remarks, Cedric the the second Can using label I physicians elaborate you have negotiations, maybe was whether that response but mentioned about doctors filing proposed will that

Cedric Francois

Okay. Thank Phil. you,

So as so the this this preempted I to discussions. label went mentioned proposed FDA we earlier, with the amendment,

that agreed full that. XX-month include So FDA with we the we data. propose wanted to The

release run on sure to that alignment. make subject full important were out So the we we the agency via to it's we agreements, press actually our did that in the after point issued that

and why path why we us And of physicians. best that you this don't is And will important? in believe so interest we chose, the is that Adam, be the which patients tell

Adam Townsend

Yes, absolutely.

Phil. thank So you,

particularly the and about the Apellis the excited between the consistency increasing more team is efficacy studies actually time, safety. the whole obviously, X our data, robust over and of XX-month So

and comments in we’ve one of specialists drug are not tested the more not the U.S. done and in market So months a drug thing on they talking their perception. much in patients the And that from research, the And of between surprise and is how we the months comfortable the a specialists profile ex-U.S. we’ve with consistency to retina about and XX broader profile studies. XX improved at XX efficacy months. of X our the XX set months, got retina about based

data we with as have that -- easier patients. physicians strong will education And I expect will much to continue do I launch to into their there. have a So result as to disease-state them expect patients and conversations more would the efficacy that discussion bring of a

Cedric Francois

XX the patients all way, therapy and Yes. the issues that that And monthly month. this just rep, just year in it XX% out from linear growth a other the slope has a XX% we're the with to the think XX ago, about into analysis every on familiar piece-wise ran and for slowdown trial for the the

important XX something So that these between for X important and generate, just month find months important. XX we is data studies, XX the that that's an are us. Again, really at that particularly and effect consistency between

Operator

Seedhouse Steven James. Raymond of

Steven Seedhouse

prompted we today, instance, about wanted that agency decision far part with Cedric, tell just you give first why need I release full as to back did to this on the announce Why running an I’m mean, of you earnings? the last elective since submitted Just still the alignment. not the was you’re on in go comment to just as to made the your data. week sure a even press XX-month press as haven’t press a place. curious I can by release you release make what

Cedric Francois

Retina Steve. Yes. Thank Society. you,

in already patients, this which angiogenesis, important conference would and one, one, year. February. say, be the really of the do is last the After for the I'd this and we next is physicians So Society Retinal

the this the really we with openly community. Retina wanted about So to to speak opportunity have

Steven Seedhouse

Got it.

competitively? potential Iveric competitive this being the did how next year there view competitor a you much did and that in physicians your play might on of this how or and So to got decision? then evolved dynamics specifically then how and have label the changed market feedback decision? going that's from And into how much anticipating And position AAO into also Okay. play

Cedric Francois

that And a to So look, we positions very that have then course, we we profile XX we believe competitively. bring they at physicians us believe well can are we that patients. -- that communicate can to product months of exciting

that. So part they, factors these But competitors colored. our luck, Many just as a wish as are of into are towards… forward never well it. unique of we Competition move decisions is that go the best small

Steven Seedhouse

Are without you other month both subgroup amendment, -- foveal this Or you in both probability lastly. the would Just label in anticipated and the label? this included those of specifically every regardless? have the the does dosing being enhance of

Cedric Francois

The And to yes. is it that to answer relates as AO.

So look whole do. did which, impact recall, as analysis so we we month as the of of American complicated, better September, are know, these measurements Ophthalmology, treatments, to because -- difficult of Academy really what the you in can at the be the understand you functional these was may to

at the good how the little we But noise, again, we was. it had And a AAO, quite was microperimetry. the we on So do continuing think XX-month was believe something meantime, the next in data a and really that in to the a frankly, lost society look in bit setting forward again, to I opportunity we to hire very that [ph], year. that want great data

Operator

Jefferies. Howerton Chris of

Chris Howerton

data. the was I respect had XX-month to first guess I one the with

versus or just understand relative guys of peer-reviewed the in question specifically. and those the XX-month perception Retina known the you journal maybe the Society the terms wouldn’t Cedric, venue? article? data then another of importance just So of the a they already really itself If change clarification, And in us the have the being label high-quality second on comment does is because help there conversations how at it’s rationale a in could it label their just data, being

Cedric Francois

about us. Thank you, to over important white article it Adam hand going label Chris. I'm versus to to talk label first to and is the

Adam Townsend

you. Chris. Good talk to to Thanks, Yes.

And could ever robust they’re field-based label the have field-based to education. those my experience, get we label important a teams based potential It XXX And in with out as Apellis. most be the that approval. disease to have the going at about is on important a voice employees most there document physicians. really obviously, allows So conversation have talking our we day we language

here. So I a mass think us for critical that’s

quickest We’re that conversations the also make that’s and our to with live that’s possible. data nimble X,XXX target. getting that priority. the going quickly a those we out of doctors to of have move there as to robust we post-approval physicians. conversations that are way sure those data publication can retina And most Obviously, very as And our supports the will

Cedric Francois

for to Thank want you, Retina It great bit elaborate Society. Adam. little Fede, the And that. you on cumbersome. then was a maybe

Federico Grossi

that Retina America the it But actually that the to where to the and the ability the basically, at conversation rural there well go changes transmit important out as we is at towards that a the important based the have data, this message KOLs. know but have it’s Society have important. these the they So doctors to available months, to the to their message, doctors in for Retina need the point on the simplified places retina as us. incrementally there if Society patients doctors, talk XX all was will for well implication practicing you And and be are about

Operator

Baird. of Kusy Colleen

Colleen Kusy

Can short on that this empty for sense original inclusion? you was And tracking writing? the it schedule alignment FDA how especially do the the on will of amendment? the the from accept review, amendment? review have comment the the of you how timelines a prior for XX-month you the likely to And that is just receive NDA do think FDA Was then given the your you timeline to if feedback

Cedric Francois

Colleen. Thank you,

first with on mentioned the release I that feedback this to specifically press respect was with a the question, e-mail conversation verbal all, of first So earlier.

PDUFA when be process, to expect we issues honest with weeks into to we you. a will date. in very get be a the smooth was there this So And submit where will and new to come, no we

you tracking? because on question, a careful, Colleen, was sorry it So were review then the second bit

Colleen Kusy

Yes.

a of to review sense -- Just if to have prior tracking the if NDA the schedule was this amendment? do you

Cedric Francois

Yes, it was.

worth that very a concentrated So it's here, review again, Colleen, this was mentioning timeline.

Type So a review, X we submission, X of from months submission. for the but know, NDA had as meant, priority time which a you priority

increased before, very with between timeline smooth mentioned of So as very I then everything in decision process file a end was, a this be yet into short decided that has and And July to to amendment. now. the the we that

Colleen Kusy

That’s one an all follow-up. the likelihood change thoughts advisory FDA on Does helpful. And quick at this meeting? your of committee hosting the

Cedric Francois

It does not.

was no there So mention or discussion of [ph]. an ADCOM

Operator

Oppenheimer. of Kim Justin

Justin Kim

thinking Maybe of upcoming just and back step recent taking applications some data a and landscape for with updates about systemic compliment. the

if curious also as thinking implications ASH an the Just next had any any you getting think the combo Nephropathy, B? team year? clinic such updated IgA modalities oral as the And of that’s of of perhaps Factor data at targeting about siRNA earlier-stage upcoming on some into with

Cedric Francois

Thank you so Justin. much,

immune as of arthritis. complexes focal [ph], our globality IgA now, intriguing property at and know, nephrology So is Apellis continue ASH you are with is point [indiscernible] we programs look that. course, not The us. a set and the to Right for

I a the that nearing future. excited to about can are now further think siRNA, it's where up we near that's we a control of wide therapeutic consumers across the And that another in program and NDA potential has broad testament very on areas. the are range

Operator

Citi. of Nochomovitz Yigal

Yigal Nochomovitz

you your able team obviously chain as timelines, quickly the you regulatory think follow a the of quite a which correct, full to apparently time the XX-month the which you moving wanted So you as accelerate at have data submit of to that to be just to XX-month elaborate is enabled enabled if you in more internally to data. would terms move I'm with what I little I specifically original triggered then the data, the As expectation XX-month reaction, bit move which of I as that understand, up allows Could just not Apellis faster the to with preparation happened ended now? preparation up.

just could be me you that out, sort that great. If would help

Cedric Francois

Yigal. you, Thank

outlined first But timelines, January, and September, one planned more X factors, in on least we you changed So of combination it beginning script. the hand, as at And multiple less. of launch not weeks, that as for in well prioritize was mentioned, the the finding the of over which fact very then things, or to a all did these we the which of amendment in with hurting that the hand filing. became of doing amendment of the an and European filing hand possibility without want and the course, Europe preparation very quickly the But moved of The clear. go each an efforts in other. were forward

was meantime to fact to and our file the working course, team of important. amendment. commercial for for is a the us, we strong that realized plans a when few So minus or That message the to very the delay in J-code penalty that the weeks was on weeks, pay combined current without only here with that hard considered the this a X and plus possibility launch on be the very

Yigal Nochomovitz

the help of you to familiar it. lot why sense. makes then reason X- a everyone just timeline by with J-code the reason starting full why matter? that J-code walk October? versus you that explain the can That less Got just the impact doesn’t through Xst specifically launch January just permanent what’s getting Can of on Just maybe starting Feb And the on Okay. delay who’s to to process. X-week the doesn’t between end

Cedric Francois

Yes. a Thank question. you, great Yigal. That's

essentially, issued So get quarter. by J-codes permanent

ship of for to second And likelihood does And to that difference logistics over that past or there supply a at half J-code was of months context, February or not the in launching half a is your going And J-code. is beginning on the that. place the January in X make time be us drives or and permanent realize for first to month that us. the October so led in an what to trial impact of the the first be the get what

Operator

of Merle Ellie UBS.

Eliana Merle

in you terms all just Wiley or itself, speak higher of the questioning reason it or I with Just the the FDA, perhaps it who someone Wiley ultimate growth FDA is your approvable endpoint? the the after to the Chambers, than that within Is expressing guess lesion I could that still FDA GA guess just at or any then considered an higher? can even might clinical FDA, the like interactions approval? signs with confidence any to And somewhat be the approval become Chambers meaningfulness division and the doubt. ophthalmology think

Cedric Francois

Ellie. you, Thank

has as as nothing we far So changed. know,

So there at is process or change is mention how all the endpoint. has been in approvability there and a growth primary that the never the lesion a

So concerned about. is that think anyone not I should absolutely that something be

the border the end at process, that And believe the the that there So on the a [ph] think higher understand Dr. FDA, regulatory then problems that day, is division of where the a way. to of But getting off approval of in determination speak the how is that, I I it on Chambers believe, process further typically signs sign that the I be. of don't to emerge but it. I place makes

Operator

Stifel. Annabel Samimy of

Annabel Samimy

to that’s about on I is endpoint? understand purposes informative XX-month touched I guess, which guess rigor can on help for and label just the I case you us information it? with if the a the you little accepted, any data, the placed is data whether the XX-month bit the it just primary be for before. reviewed Or be reviewing FDA going can to But talk it going [indiscernible]. is is statistical then so as

publication physicians a the wait seen already. So multiple it like the of a I’ll for They’ve just times seems now. it because date lot know

the how data other this FDA want be that you’ve to already just submitted. looking data understand to is versus going at I So

Cedric Francois

hopeful the at Yes, that language primary we you, are we months the of XX that makes XX us that, Thank be that got considered hopeful months endpoint. need may Annabel. course,

with how And effect that is. the I So increased the overemphasize time strength data. that again, cannot over combination in powerful of

getting important is that. you decades. This a the as and And X the of FDA increases fact into and XX%, patients, this ZIP think hoping years. we longer primary least of the impact that is reason code XX a to now, go continues that at a the X affected this about long-term are sometimes extraordinary. is is treat talking that The years, patients that's why hope You're creates well. beyond The of X a not or X terrible, disease of And these for to or with lot it we're this year all mitigate for is really remember, that, message should disease I is where disease the hope. endpoints

these are I that, to these -- just follow up patients? on So guess, are

Annabel Samimy

that. on follow-up to Just

Let I How the me back. I question. the XX months does XX change from months. went months the to just often mean, endpoint? XX just FDA step to that’s guess They

statistical is months? at months was another was, it So as XX as it asking the that’s as the at was guess it I of way rigor question. XX months intense XX

Cedric Francois

get we that communications the is the FDA. Annabel know from we All

So we we those them. with go and write along don't rules,

say. So that's all that is can I

Operator

of Needham. Stringer Joey

Unidentified Analyst

This is for [ph] Chen Joey.

or could So second is our of question ALS year. is, our next U.S. partners ex-U.S. the study in first question either expectations core And plan coal frame or potential tax you should is, current help Phase exit your any in [ph] on what thinking plant II for GA?

consider So meaningfulness registrational? see AFS on clinical trial would this what potentially you And the endpoint? be primary

Cedric Francois

Joey. you, Thank

are we product launch and atrophy, on ourselves well in ex-U.S. partnerships U.S. this have the geographic been preparing So as in as to

that and been be plan plan. So to continues has our our

high-reward this high-risk, the relates is, study, of ALS As a it study. course, to

it, high So for the But study, of and meaningfulness likelihood the meeting meet to company should all clinical in we that for going like endpoint would patients. be it is of be low. primary the of studies course, human and ALS

Operator

of H.C. Wainwright. Tsao Douglas

Douglas Tsao

of been questions by the most Was what physicians, acceleration? of in just the of Retina data? curious But A XX-month answered. lot from about it just it, what they it data, think were data? to did that have impressed it due perception terms you from already said curious, Was feedback. my I’m What way, the feedback terms meeting, â€” Was or the curious it in I’m XX-month XX-month Society got the was safety? didn’t that a of change Was maybe their it the in terms -- different just efficacy? the

Cedric Francois

the Doug we question, retina. absolutely honestly, and ground-breaking in is that between for you data remarkable because, The is this it. why Thank and the did XX XX

getting incredibly to seeing XX% slowdown, this drug the those X patients. of We which years, time, into of how those this XX%, increased that by works important end discos is these understand are effects for in with disease. over that phase We're again, starting

run. that the impact to microperimetry starting are analysis see these functional on also We we

in that these are first specifically things can all are was AAO, as really patients, we last cells results and course, on the vision photoreceptor but look It's OCT of images we rate at where And where presented also these have So least, these something at not honing extraordinary important. at the detect the which on lost. the that cells in well. retina

understand very major and these things direct how border able look about to positive and important talk of starting and we to really all So label with many community. forward we being amendment and works, this through this that the the are to was of

Douglas Tsao

that Retina quick imagination a as the all physicians anything of just Society at maybe really captured -- the was points, And meeting? Cedric, follow-up, was there what the those

Cedric Francois

Yes.

would This of at was bit photoreceptor work the that say but the in our gets Austria, looked by captured specifically. most she in I a where the the Air their little images, had work was technical, these at discussions we've Force done. imagination looking So cell done was loss that collaborator, we Lucerastat OCT again, that

as supportive the not XX% in in had that of there, that DERBY points, time as blinded as OAKS, much And X-year the as this in we in we saving cells. both approximately analysis So after have photoreceptor you still did, well retina.

And to that add that like very think be is So of I mechanism work at that requires something to course. how looking [ph] understanding done, the well. more helpful. that Adam as would works Retina But to and

Adam Townsend

be I Doug, just you. for interesting it would Yes. thought

separation really type XX proven market studies. It’s kept just impressive out. At longevity towards appreciate that XX came became of with that its well one From And from those XX data. they but with both about potentially strong the across was as quotes the reductions treatment near Society research. perspective, months, efficacy asking efficacy really DERBY’s opinion we’re research, We there miss and research. of used XX-month therapeutic consistently month effect impressive impressed market effect we data we a an at also by clinical were after that of I’ll XX% the of curve And those the specialists, the effect. the our getting the to within of key retina You’re about overall don’t we leaders is word the research, as which from after research. impressive. got meeting, start during meetings. months. to XX-month And time. feedback our as Retina X summarize go the those such about feedback that already the robustness that to the market speaking consistency market that physicians market conviction was to That months, increasing was but The they continue type get of really of is the irrelevant

Operator

last question Sachs. of from Kumar Goldman Our Madhu comes

Unidentified Analyst

Rob on It's again.

impact had the IR, Just to one Act inflation was, is moving potentially there question we XXXX? Reduction and any the other the back from approval

Cedric Francois

Rob. you, Thank

here. You’re I that. dipping No. double like

So to where this patients When decision-making get point was it’s that things. going consideration And the generates when and we believe our there circumstance, look, for this a not better It it’s comes late. a and we one they’re in to evolve are for always that they physicians. process. never But confusion. several understandable truly be circumstances but and

us PDUFA And to is choices. to difficult it comes. but serving believe going not very close as make doing next to now well year the be it’s we ideal, have you Sometimes the

And after So anybody question. Operator? you you, there your for thank else is

Operator

That our all. Q&A. That's concludes

Cedric Francois

Thank you so much.

joining So in closing, today. us thank you all for

questions, and reach you have to later Meredith. additional today feel around tomorrow. if please out free are to And We any

Operator

the for your in conference. you participation concludes program. today's This Thank

You may disconnect. now

Apellis Pharmaceuticals (APLS) 8 Nov 222022 Q3 Earnings call transcript