Apellis Pharmaceuticals (APLS) 29 Apr 212021 Q1 Earnings call transcript

Company Profile

Participants

Tracy Vineis	VP, Communications
Cedric Francois	Co-Founder and CEO
Federico Grossi	Chief Medical Officer
Adam Townsend	Chief Commercial Officer
Timothy Sullivan	CFO
Anupam Rama	JPMorgan
Jonathan Miller	Evercore ISI
Madhu Kumar	Goldman Sachs
Yigal Nochomovitz	Citigroup
Alethia Young	Cantor Fitzgerald
Philip Nadeau	Cowen & Company
Justin Kim	Oppenheimer
Matthew Luchini	BMO Capital Market
Joseph Stringer	Needham & Company
Laura Chico	Wedbush Securities

Call transcript

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon. My name is Sarah, and I will be your conference operator today. At this time, I would like to welcome everyone to the Apellis Pharmaceuticals First Quarter 2021 Financial Results Conference Call. Today's call is being recorded and a replay will available at apellis.com. I would now like to turn the call over to Tracy Vineis, Vice President of Communications at Apellis.

Tracy Vineis

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

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

Now over call I'm to turn pleased to Cedric. the

Cedric Francois

Thank It U.S. pegcetacoplan and you, us call. is joining an PNH everyone paroxysmal nocturnal exciting approval of hemoglobinuria Apellis afternoon a away. Tracy, potential weeks and or couple time of to a conference today for just our at good with

PDUFA prepared launch approval. shortly fully after for are We May RFP to ready XX pegcetacoplan and of

will Our on Townsend chief latest to in Commercial efforts a updates our Officer successful PNH. launch Adam provide the ensure

of slide PNH we this a in published three incontinence phase to the on In PNH our results see advancing with thrilled Last in advancing Apellis. systemic approval start are CX. shows, atrophy, lead innovative leading medical our month Apellis. first We across study technologies or just focused science leadership results rare, data high the our recognition treatment potential the our GA for we were are community plan Medicine. the With year any as what complement is will were in the and transformational with underscores the geographic Journal to establish complement aim complement-driven our advance of on geographic on targeted at to be that a retina a to from PEGASUS the for caliber from England as programs published our by indication global pegcetacoplan and we As focus and diseases. in of to PEGASUS journals. three importance to one to PNH therapy PNH CX GM disruptive The PNH continue we prestigious New the factor in treatment control become atrophy and we number

analyses separate in American ophthalmology. Journal in two of our Additionally, were published study Ophthalmology GA affiliate of the and

But people expect and Geographic cause Medical phase this more and the Our We disease. than publications living has worldwide Federico showcase in relentless of Grossi atrophy for to the also people GA committed of confidence the responsible upcoming from with year. disabling remaining Chief will of of the this believe Officer control broad for all of diseases. our the GA. Apellis publications GA our our with lesions the is CX and million targeted provide together complements-driven important be for results platform event in the three the Apellis later. the will CX which therapy details reinforce additional continue Dr. our for to and potential third The we Topline quarter DERBY readouts OAKS and studies an these targeting to for first a leading need most potential in advancing retina. are that complement activation significant blindness us excessive growth at potential living X treatment unmet

key frequent strong are clinical development next areas; advance on pegcetacoplan. These year. studies of include that candidates will control that seen maintaining host will three researchers an the while our of product new new we to plan to focused R&D clinical into benefits dosing technologies day end class XX, complement. develop Finally, June On world to continue less in the by programs multiple we

closer and thirdly, more get details to look We forward as to neurology. new all treating exploring of in we Secondly, forms sharing AMD the indications event.

transformational a year is mentioned I for XXXX Apellis. As earlier,

over Officer spent We to those foundation several seeing to the come the past results I'd the look together like And we complement next of decades efforts forward our leadership Chief work our to of and diseases. have rare the beginning our for for Federico? review and Federico call months. building Grossi Dr. pegcetacoplan across now the pipeline a updates Medical to a turn complements-driven establish over as therapy our with systemic disruptive

Federico Grossi

publication Thank to The for will demonstrated foundation the looking phase the serves potential a our three with positive remain begin to results for PEGASUS recent of PNH. disease. of and I the of upcoming PDUFA with profile and rare the significance on track that the medical patients you, standard community Journal Medicine England Cedric. of day study. build We reinforced pegcetacoplan in to We're forward the elevate PNH care clinical May first of XX. hope the all program date and result effects pegcetacoplan the the the as by the on since the New from PRINCR these results PNH strong of with

phase LDH with in assigned slide the in is co-primary endpoints the endpoints or PNH studies and and those treatment-naïve in These in evaluate primary focus intravascular levels. CX intentionally on stabilization patients PNH to hemoglobin two previous inhibitors weeks therefore were of of transmissions XX on reductions at PRINCR study shown analysis. X used absence As aligned

of Adam? preparations. or an I results believe Officer of hemoglobin will Townsend where both call critical has endpoints on disease from Adam overall considered our by allowed FACIT-fatigue and the measures vascular gram However, secondary hemoglobin since of the extra PNH transfusions certain this impact to PRINCR would two CX deciliter over that to primary and per historically Chief update to including we levels at June. is pegcetacoplan PNH that like hand to deciliter hemoglobin grams studies by hemoglobin are levels. the set the compared end considered intra unstable. per before levels patients. the now May for our one are drop high inhibitors the score beginning Commercial on I to sterilization provide launch for In levels characterized on CX PRINCE to of excited being unstable by also we studies only endpoint you patients to see have previous analysis, If inhibitors. remind bar of a We're dropped those

Adam Townsend

Thank you Federico.

commercial and excited May successful PNH. a for ready launch ensuring date laser pegcetacoplan are Our U.S. on focused our in we is of PDUFA and organization

urgent new reinforce research Our PNH. treatments to market need for the for continues

As on see that unmet to show Ultomiris. you of can studies CX with on from require despite and treatment current significant people needs transfusions inhibitors with Soliris this to to continue X/X Retrospective levels. falling continue suffer that patients CX slide, hemoglobin their address inhibitors like PNH

significant inhibitors patients remain of only symptoms levels, Another other closer and of third anemic address final is of on fatigue. there normal standard living blood severe many hemoglobin bone marrow. have with cells that to ready maximum output at experience the CX elevate of from people like PNH the PNH these and in is the need we to pegcetacoplan Thus achieve at The but needs team patients for launch. their third to our of of red care believe a expense commercial

launch outlined on preparedness are activities Our this slide. latest

average six efficacy more value post months more all that engaging high reimbursement and anticipate unique made access is U.S. positive completing On feedback decisions the of clinical launch. to during approximately of payer and on team interactions received This representing Our be includes which we safety profile we pegcetacoplan. with patients. priority three XX than to PNH than payers XX%

infusion provide access it to We've that a will patient who day support their continuing our of self of our on on our work treatment care Assist, the provide any administering ensure and We train program chooses throughout quality copay a patients journey, to experience who patient dedicated support education system will make treatment as educators treatment PNH to Apellis pegcetacoplan sure from Apellis will hard help design a and distribution Assist met. programs. are one Apellis eligibility well pegcetacoplan. established support includes resources will model for assistance criteria including high where and as have ongoing with launch. help This training, patients comprehensive

HCPs field and on and virtual engagements As their HCPs. education patients through obviously COVID-XX teams all team diligent areas and navigate have In our commercial closely regional our the we following engagements, remain meantime, affairs we we in healthcare digital offices, monitoring meeting guidelines. in we commercial can is both In have for restrictions. continue where and focused medical person appropriate remains or professionals, will in to both strategy COVID-XX,

disease We COVID-XX any address have built hematology experience force has rare we a and to and this the believe very team our significant challenges with strong in environment. set sales skill HCP right access

launch. of are to Finally, more the XXXX and March the deployed sales the experience and key in our been for HCPs spent preparation as PNH years the with including have first last to community top We've treatment centers. two XXXX than and to trained our XX cover listening engaging focus teams

need back We the broader care thoughtful very the a developed the launch In from to see Officer, then and approach our a are transitioning pegcetacoplan decision to parallel await with the has strategic with later additional for GA our will and to call as studies Federico? of systemic PNH, Dr. to plan Medical results GA. organization now future continues the approvals indications as Chief well the excited are and team unmet patients standard patients. of commercial upon potential first Grossi of elevate to review the our we to Federico ready FDA to turn Our to I the and this approval. reaching our program highest group year.

Federico Grossi

Adam. Thank you

AJO patient [Indiscernible] did Vienna's and characterize a on also accommodations AJO found found vision. growth second the programs observation [Indiscernible] have this is upcoming in across Verona programs therapy. diseases clinical common three hoc progression. data for analysis X year. including and risk focused pegcetacoplan including profile reported This have eye. AO has oral where on were of Medical our to advancing clinical this for not execute with presentations two the group We're highlighted publication to with recent May. author's collaboration The the line differentiated in the phase similarly continue month and or rapid the GA ophthalmology the for offer CX with ongoing are factors from the believe results component of The consistent patients intelligence with more pegcetacoplan pegcetacoplan the accounting are Medical where with feeling Iris Last Journal Optima in when registry clinical Research CX that American accepted standard to journals product GA. reinforced treatment In significant of The that that a the history for slide also for targeting in or intravital in in of in third driven reduced a we potential annual of [Indiscernible] Earlier a therapy GA quarter. remain publication, real with the and anti-VDF results we Association the a a this phase that In of explanations Ophthalmology on month, payment our with our pegcetacoplan potential in few of to from collaboration at meeting wet-AMD University post publications we about on of milestones major PNH, targeted even Beyond the Ophthalmology ophthalmology outlined half artificial in a meeting in more responsive of world no top of first excited investigator profile. show diseases publications rare the positive of mined in for studies with analysis become associated subgroups were five study vision expected and meaningful effects the pegcetacoplan people options and and determined registrational impact presentation several initiations systemic in patients announced were the we Health. study are lesion

position patients at patients new decrease there combination [Indiscernible] patients study presence pegcetacoplan patients phase in at recently pegcetacoplan were assess two we onset therapy Patients impact during leadership GA, with lesion in were in developed is and vision. XX cases compared GA XX the with no on the on were this a vision. formulation opposite bilateral designed data low in reported XX safety to no demonstrated the meeting from which of inflammation further study of study. GA. ophthalmology and important XX% and Analysis the in experience with enrolled month of Our [Indiscernible] activation of phase available X showcases Xb clinical data XX treated with enroll share The of eight strong growth months new whom NSGA to our Also from our months patients anti-VEGF pegcetacoplan.

readouts. ahead this GA further studied, program strengthen pegcetacoplan publications this the small three long highlight Together these While our in this potential in of phase is term our belief GA of pivotal results disease. continue results and to

of As safety the other our treatment some monthly slide and studies multicenter GA is lesion with at than on be GA and The can month of in more in Full will that shown the patients. of primary on reduction randomized there of pegcetacoplan slide. seen every studies those growth X,XXX the XX. control the in science compare endpoint be announced study month efficacy this

the the of review I to here in treatment the leader Tim? We see third Officer results. are Financial Chief Sullivan as quarter. OAKS results to and turn from diseases. for excited Success over us retinal call will financial will position the the now in our DERBY of the Timothy

Timothy Sullivan

Since on of highlights a with today press you issued Thank results, the will we quarter XXXX. our just first focus earlier Federico. I financial release full the for

personnel million $XX the short term the in for was costs, same XXXX costs associated were planned others. securities. activities compared million general first the the March related period compared and to XXXX to XX, quarter in increase had with attributable additional General related was The of XXXX. attributable among million to fees, employee preparation professional others. to and of costs expenses personnel for to quarter XXXX and million expenses of the The general and primarily were cash, in $XXX.X same $XX.X and $XX.X expenses expense in for XXXX. hiring commercial consulting administrative for and among and administrative clinical As increase $XX.X of million primarily due first equivalents period R&D Development marketable compensation Research trials, ongoing in primarily cash Apellis

plan. to first to the ended robust potential to We XXXX. $XXX.X March and continue period net for capitalized XX, our of compared $XXX.X the XXXX PNH reported Apellis advance million a launch million same development net loss a loss execute For quarter and of of pegcetacoplan clinical the remain on in well

operations call I the remarks. Our cash turn second now runway to fund will XXXX. is to into over of expected closing half for back the Cedric

Cedric Francois

this quarter thanks Tim. have you, pivotal our two would strong and questions. patients, helped important take away clinical months made the open look operator, this on these who call partners, commercial, next this We've [Indiscernible] PNH the and for investigators, get to opportunity and keeping please recognize updated slide. We caregivers, several several progress. on investors, anticipated us, weeks for over forward progress to regulatory milestones employees, like Thank moments. and now you to to to just And shown have we over as

Operator

you. with [Operator Instructions] First from Thank comes the of line question Anupam Rama JPMorgan.

now is line Your open.

Anupam Rama

physicians? most I've Question. about your treatment I different and geographic it's of was related getting rate rate arms the we getting or the it from is exudates are of recently the on data and some important relates metrics to CNV of presenting wondering research or whether phase the if related three studies of portion VEGF be top-line the a how should thinking I in you're from patients market topic could and about oxidation this ask what this a a as atrophy to question the thinking been that which the lot how

Cedric Francois

and Thank great Anupam your so you voice. hearing much

a that indeed quite is often. question get we So that

as will these think there to I element exudations. first is the we physician-reported mention report that exudations

based that study because X city baseline into off in in one when potential and contra in that with that investigator compensate were studies clinical of high we study, the hand [Indiscernible] large clinical similar with Adam in was the quite did eye matters the the phase we what briefly of started clinical times better represented patients less also XX% trial already So GA discussed well we the that And that it trial patients a to years. course two patients wet-AMD phase caveat at with before knowledge the who of how adoption. feedback much and study many for three the and rely to from very of the phase one is phase to came by X in wet-AMD two study development have that will exudation demographically was that it the over were program type controls we known wet-AMD we as eye done number excluding to etc. in on competing give DERBY another extent heard brief have large that of sense is to in that of because with the on I particular with a physicians development that it rate phase have with approximately X OAKS the patients did bias, trial, the the terms

Adam Townsend

Cedric thanks Thanks and Anupam.

FILLY the them and of very resonate resonates ability So piece about with our they parameters that through that with physicians average slow within we ophthalmologists. the consistently very market our That's impacts lesion, specialists some then research a that meaningful if market with that XX% to retina clinically be in we our get to found important is retina number less that of XX% and injecting the find use growth. you we lesion ophthalmologists KOLs we saw GA strongly that specialist the on growth starts and and one lesion well study based research

So lesion strongly around and as they FILLY safety, prescriber physicians size, very is that One is ability dosing, very can't consistent thing They much help who some for the patients these also with lesion can. roof data growth of the emotional thoughtful mechanism. there's and replicate administration as a our base. are to currently burden these

to and patients impact we the big the towards to GA excited on data the a year we're have see hope So end really-really of forward. moving

Anupam Rama

given into now the out on a I a of squeeze regulatory there's of in? concern guess some on PNH getting question is kind maybe I right pushed - From perspective terms us the PDUFA give approval could interactions in going quick more if then, one just high you level And your here could

Cedric Francois

of much you Anupam we get lot course of and so a on that questions as well. Yes. Thank

We within our of PDUFA are two weeks date.

in commenting good went not knowledge to public any that major will that regulatory through announce. we this something are month of middle we on the It So at findings this point hopeful have we is process are the without and questions time. whole

Anupam Rama

Thanks so much for taking guys. questions

Cedric Francois

Thank you.

Operator

Thank you.

comes Jonathan with Our next Miller Evercore of question from the line ISI.

is line open. now Your

Jonathan Miller

Thanks for at six reimbursement three on the and launch PNH guess. Two; a for up are payers PNH on I through happen GA the and question. that getting those launch How reimbursement so up follow-up guys. months one percentage mentioned much that You government process. for for are as Can payer discussions point? launch ramp going commercial Hi commercial expect this then taking what talking of versus and patients payers you through to you us how talk you're what's about government well? the to

Cedric Francois

I'm that right. hand to over going Mr. All to one Adam? Townsend.

Adam Townsend

you. question. you Thank Thank for Jonathan the Yes.

of our firstly So fully and all the payers positive. are high is access more payers representing staffed with hugely couple has value last One that our thing and of than been lives. engaging peer been team they've XX% for is months out interactions priority stands and the U.S. PNH of those from

error expect edges. and Medicaid of part step the governed and commercial question we six to the issues and coverage their under see and take processes We post months reimbursement. the your other a will between have and private payers with three expect bars quick XX% are that on side average and the some us insurance slight major through broad get around does with don't with of to XX% we second work It patients any launch for those internal Medicare

commercial as months. the they before months plans XXX the and on typically days the six that plans expect take to three to Medicaid about six up plan Medicare to We said is up I and about

really-really the is they've Our with pegcetacoplan story interacting very-very value how in payers. impressive The strong. team is in been of

move through will payers those we'll we payer given access work smoothly landscape wants through any be U.S.-based that access the so we be So to drug and discussions even prioritizing we're onto patient I've as that come to able with described. believe our as that

Jonathan Miller

Obviously the guess plateaued from highlighted gave you then seeing a noticed follow-up safety to you on a Great. like phase we're looks efficacy I that study versus but update That me this delta XX% makes we little be there as X GA. still efficacy number Should some and I the that general to bit has GA? it there of sense. this we the delta at update. impressive plateaued that be around very last should level but that with expand the expect continue or headline expect to could dose to observation increases? pegcetacoplan

Cedric Francois

that much, great you Yes, so is thank question. Tom. a Again

patients. forward to by course year the from geographic Of larger looking need start I which we years. are set is It to becomes readout level works determination from Xb a or interesting look but an very way What by should sample in that pegcetacoplan regard. when to mechanism on the to very we study in that results make the going small say individual of the atrophy patient phase on you even a disclosed two the we in one studies

Jonathan Miller

Very nice, right. lot. thanks All a

Cedric Francois

you, Thank John.

Operator

Thank you.

the of Goldman Our Kumar next with line Madhu question from comes Sachs.

Your line is now open.

Madhu Kumar

Hi our taking guys questions. thanks for

PNH PRINCE So I'll on of happens of start kind is the on contingent we date? about PDUFA what readout how PRINCE with should think trial. your kind impact and and has it How the with the trial that strategy what

Cedric Francois

so Thank that question much Madhu. you for

as many three to an So designed there phase trial we've was clinical insurance as very be a is treatment-naive the PNH times policy with patients in PRINCE trial before much that mentioned study based was is trial a study which things on did PEGASUS that to was currently which the because three do when we our the clinical one. in aimed phase three that approval

PNH. that pegcetacoplan of for was all systemic show First a treatment to

background. go a some. for study patients to everything gave case snapshot PEGASUS we in now is uniform would to was the show three then could We Well, with because out that know and of are to it to as not a into PRINCE plan. to that in in two advance. would there course, that there Second superior Soliris safely drugs turns lot hoped to from much that between the handle give a one more direction had and either number things us outcome wanted show trial it be for really you according PRINCE be we, to us didn't PNH switch and the

patients as as sub-optimal stabilization not PNH responses more this to studies in far broad PNH the So population the what levels. is what on could that of and so you we but treatment with hemoglobin all call the of case with measured see Soliris have in PRINCE representative dehydrogenase we've seen of and of of measurement by good lactate in our control control expect

Madhu Kumar

Okay. Great.

PNH I'll questions. probably outside design a based far up to of do you kind the but answer of Soliris question [Indiscernible] got is have so able to think One, of follow two but PNH post data the case it's you're kind approval So not make a like with be and broadly going try PEGASUS then there for to together? I all and for pegcetacoplan what given in you of the approval extent on treatment to case of in

Cedric Francois

assumed we this correctly the of two discussions PDUFA. away comment weeks you from we course on as cannot only are So at label point time since in

a period believe we that we in the past treatment-naive good control PNH with say I long the monotherapy study PEGASUS pegcetacoplan. in showed in commented of that of have We should

Madhu Kumar

I'll have at go question. Okay. GA a one

of frequency wet-AMD? to think do treatment differences of GA the geographic and about how you kind So the to atrophy compared similarities and for treatment of dose the

Cedric Francois

much so Madhu. you for Thank question that

regimens not blinding it the the of in are I be and is physician call for and I'd the done a minute there different process. it a manifestations retina disease as physician X disease currently that but no atrophy to a, these of exudates to say that disease similar kind patients two Adam it the geographic which will to go is of is understanding with lot a it it relates an treated is a So will away. the treatment to a that affecting is the have and the when relates debilitating word as million patient treatment receptivity that hand very We've anti-VEGF I'll the line bottom you world will feedback and two underlying in is to work have probably immediate in as

a it are treatment on that to is and a clinical rely intelligence, more an will where on the patients will these phase that this the we could as physician artificial more you well much able what regimen hopefully photoreceptor to our we about patients is the down. particular be that order So to much predict with slow to background rate the drug the going of patients do and three in in in establish as trials natural prescribed GA sticking and will see to in at cell working conference be loss what

I you So if Adam every as monthly relates something it know don't other to to add versus month. want

Adam Townsend

Yes. Cedric. Madhu. Thanks Thanks

that yes excitement chance have being obviously drives is no the treatment. approvable and we one So in thing GA the so that apparently of first the product

specialists patients driven dosing motivated So patients they're inject we dosing to being every speak themes, have them monthly some patients get to retina and also we like infrastructure great and get responses fine. are around type the along and I GA infrastructure is from we think see equally can My we we these of when I so it's get month. comments wet-AMD the

forward excitement towards about to I'm this great out the seeing come a year. the data looking I gives and progress So we as just options of current the us end think treatment

Madhu Kumar

I right. a our we'll All taking questions you guess Great. Thanks couple all for hear from in weeks. and

Cedric Francois

Yes. Thank you Madhu.

Operator

Thank you.

Our Nochomovitz next comes question Yigal the from with Citigroup. of line

Your is open. now line

Yigal Nochomovitz

two GA. and on the team much very Cedric had questions. you Hi I for thank taking

explain market regimen? pegulation a you're And Will will Regarding lower Thank news with confident causing since OAKS, then was also isn't the just just month plan? what -- treatment my every up commercial get the you. move quarter other the that's and burden or if want if end and you is could the in to other third you there why any monthly DERBY month forward second and the would being every reasons you the both monthly why reason the you be very question that exudation? good the

Cedric Francois

words much Again Yigal. so have geographic On other to questions. worth response reasonable it mentioning dose expect we efficacy other want In to every to on atrophy seen but it's two you you that. be monthly hand I month. is the everything think based to very again Thank good unlikely that if I a will to is Adam for a it identical call

account starting be relates want something take efficacy into if to So Adam premise to it that? I that to as something advantage from you add that would don't to know commercialization.

Adam Townsend

No, I well. said very you think it

us they're moving think both forward. important I for

Cedric Francois

Thank it you pegulation. the then Adam and relates to as

that are it call the at So are that that I I'll to glycol kind is highly as very models it that artificial models. agent there have important point out can exudations polyethylene publications an out promote think few certain looked in of

these are macular not they one a So where I'll of laser-induced ablation. degeneration. give animal models example do

That effect you we you is that in very what essentially of driven going and that a the our and induce from be wound in digest laser effect the So is type that glycol very see not have to and polyethylene glycol degeneration is how much an on different the that of healing wounds of the may part an polyethylene course where a retina macular pegcetacoplan in on shine by we occurs. do has believe patients. exudates

Yigal Nochomovitz

Thank it. Cedric. you Got

Cedric Francois

Thank you, Yigal.

Operator

you. Thank

of Our Fitzgerald. Alethia Young Cantor next question comes from with the line

Your line is now open.

Alethia Young

there you're like the the any about then like pegcetacoplan differences can the notable just kind it you questions to running Thanks. Can in pegcetacoplan the if can U.S.? and Okay. relates in market, talk to and it conversation that relates too. and just EMA it Thanks how for you little think just been as versus of characterize Europe have segmenting of you just as U.S. practically obviously a talk taking speaking they light bit but about my big study

Cedric Francois

Adam. Thank will you Alethia. of first so again part that to give question the much I

Adam Townsend

Thanks Alethia.

a obviously yes So segmenting GA sizable there. market very patient demand the

to expect be found the segmented we size consistent one So is that's market bit GA a and location. thing by been little we

to with parameters that also is So into lesion and small, nonsensual you speak you some that that patients bilateral central resonate or and physicians find lesion you large how apply to naturally features that take clinical to the of then when be They patient and seems etc and wet-AMD. some GA, segmentation or is account treatment about the the medium, big consistent.

market. GA occurring see can segmentation demographic size lesion the the and So location and that patient way is the we within

Cedric Francois

Adam your and as then relates it question you, second Thank to Alethia.

regulatory indications, to speak directly has PNH and guidance no ask that you commercialization tell from for to partnership perspective it out set I the we you on a months systemic been a So and questions Sobi, our with the pegcetacoplan of as this can ago. and path would the change fantastic related in what I with is couple other European

Alethia Young

I Yes, was a Thanks. figured try. worth it

Cedric Francois

you. Thank

Operator

you. Thank

question line the of from with Company. comes Cowen Our & Philip Nadeau next

open. line now Your is

Philip Nadeau

giving OAKS visits waxed DEBY waned. good very past COVID as updates On you've and on the been as about in missed and

statistically that FDA if you you with trials unmissed drawing today. on With close the the set update how over your any mis-visits, curious have they still visits study. be handled be design and to discussions you I'd update on the within mis-measures Are in trial going tolerances any toward out the are when

Cedric Francois

Thank Yes. you so much Phil.

has you changed. not and as top us spring this mentioned is last of the that course guidance course for mind So correctly our of been of since something has of year

last on are came year under etc. track the of a even spring trial So waves, we injections control ever be. when basis where the subsequent the visits the patient wanted the I'd with weekly them to and we say which since that

had point any quarter. regulatory we both have the FDA meet are specific this and that feel make comments We well powered without to our us primary trials providing in we know interactions with third end

Philip Nadeau

has or discussed analyst same as Am going some mis-visits? change sort the there statistics to or be to your for the how believe you designed, in the meeting the of they're are mis-visits. I mischaracterizing with handled made statistics been initially I adjustment that

Cedric Francois

statistical Yes very the sets. existing trial good again of the about have based we we changed on and readout feel the the control plan based analysis not on the

Philip Nadeau

guess you'll the price to price? disclose position Thanks. time second wait you your will a approval you you are disclose I Do at price begins on be of the actually on thoughts of the PNH. you type recent would and and then launch would in exact in what Thank pricing? or think best earnest? What Perfect. the until most access or most up when the question open the

Cedric Francois

Thank one to hand over you, Phil. I will Adam. that

Adam Townsend

Phil. question, the for Thanks

we're wants patient pegcetacoplan that their committed to as regardless ensuring yes access every ability to said can So I pay. of who have

pricing of our and sure was made our strategy the work. that that we've core all So of access patient

care to patients involved the clinical So the PNH compared PNH benchmarking we deliver our pricing of at ourselves and value moment. that can that in we strategy believe standard the we to

some Ultomiris and Soliris as disease as rare drugs. So similar well other

As finalize we have of can then our PNH and approval believe to we talk label terms start patients. we'll we'll that for potential our get in closer value to pricing our post approval about we the that

more to So come.

Philip Nadeau

taking my for questions. Thanks Perfect.

Cedric Francois

much so you Thank Phil.

Operator

you. Thank

Seedhouse Steve the question from of James. next comes line Raymond with Our

now line open. Your is

Unidentified Analyst

is Hi Steve Seedhouse. [Indiscernible] Yes. this for

and has answer your sure effect but then enough contribution quantify so primary alone a think intro robust to extravascular a you have FDA that PEGASUS. intravascular and have taking you can versus hemolysis thank you the Do the So if not endpoint provides prove question in question a for relatedly change to pegcetacoplan hemolysis this to PEGASUS was since asked about the data you and hemoglobin on you brings? we

Cedric Francois

to much Thank so nice questions you for hear those you. and

on are point commenting time away again proper the weeks pre-FDA proper is the study study in and only and a only the which regulatory included meeting been from as since PDUFA evaluations. not this this a we through two are we in has went So but process filing at PEGASUS

is efficacy contained deemed PEGASUS data and sufficient the pegcetacoplan to the in of the study So PNH. evaluate

Unidentified Analyst

very much. Okay. Thank you

Cedric Francois

Yes. Thank you.

Operator

you. Thank

next Justin of comes line question Our the Kim with from Oppenheimer.

is line Your open.

Justin Kim

development AMD. you generation thinking and but in your next for discuss afternoon tools and use can even help enhance this approach Hi, good on how pegcetacoplan touched question. approaching a commercial these Maybe little potential near-term the thanks just bit may maybe findings about taking compounds the and on bit with for a influence little of

Cedric Francois

Thank That you an Justin. question. is excellent

is and to it expect drug we want reasonably I a range we're future of what the and you work to physician could to intelligence progression for to but pricing work that. in of being is to this artificial of beyond context you hand excited framework going an mean, I'm able be So Adam you strategies. if around a interesting over very comment going [Indiscernible] to patient very what rate about. GA specifically planning natural have in lot is predict as that a and do the obviously up sets ultimately long the patients the the know the think really I important

Adam Townsend

nicely Yes very you it said Cedric.

Cedric Francois

is this Thank you Adam that we're and excited really think something about. very I yes

piece be monthly give or at I'm bear you a another you a here to but we an on patient think you a with in is going I traditionally to forget injection complaints holiday when if sure for that there the pegcetacoplan you tell to mind atrophy will see with first are geographic injection have some that won't you're year in point good difference. example

and hopefully So long something run to able this. long be run good give the is require for to treatment being able in to them like to retain going patients a the these

Justin Kim

Got just CX what it. phase whether before three question just with discuss agencies remain with sort if study initiating steps one required? interaction any maybe the that us And can on Great. any MPGN of regulatory program you there's the are

Cedric Francois

Yes. you as Thank question for that well.

the our has start the on So start second and know It requires that the are of with is pegcetacoplan half excited explore those will collaboration of to in this year close guidance Sobi course not this we conditions. systemic as but phase trial three and the changed. partner in of a you interaction

Justin Kim

very Thanks Great. much.

Cedric Francois

you Thank Justin.

Operator

you. Thank

from line Luchini of comes Our Market. the next Matthew BMO question with Capital

now is open. line Your

Matthew Luchini

Good you. afternoon. Thank

in of be from year? for of geographic think EU segmentation could treating in thinking atrophy just patient be this for bit I'm those context, I the in the data stage is talk probably with curious would last patients of level a disease, little context earlier one retina So just you me about the enthusiasm if for the Adam context physician I'd

Cedric Francois

Adam Thank you so that? do want Matthew. to take you much

Adam Townsend

of that updating our segmentation for find Yes. and driven there the and use by obviously data strong motivation discussed Thank used earlier in when we're you. Based total supported our was we perhaps retina we patient FILLY did we on transparency anticipated. than market by that actually the research and we've often actually the we even data used that found again that we for a specialists

we've are groundswell our non-central earlier. that on you you based the motivated physicians if on you again central FILLY I seen use and what even more the at there we in a for the treatment small look was and think look and look size motivated and the find So lesion lesion else segmentation at to in what and at being small moment everything that be based you at size we're wanting publishing that see they'll good the

the the data of the So again towards we're see end excited to year.

needs for opportunity GA. good in some unmet help a to So us meet

Matthew Luchini

but and to part perspective? pegcetacoplan the the your drugs at get particularly dynamics then part out presumably successful views your curious thinking coming a political be a would drug a that pricing you. approach it's of around second little and your is would being bit to since one sort And geographic be on perhaps Thank just price VEGF hard point particular your to this of evolving thanks. b just in a sensitive assuming large to from Washington tend be to think Great answer fairly atrophy

Cedric Francois

that? take to want you Adam

Adam Townsend

Absolutely.

benchmarks that first to it to you So initial that when have centers in and the access of as that patients coming and is initial discussions if our their be Again gravitate pricing so the we us I access thing that on. drug our on to can and our for what [Indiscernible] again speak want GA one value done we prioritize Medicare. early as PNH. have based naturally OGA anchor we're pricing out yes, that obviously good of in when it's right they we'll be rationale I physicians then patient you're to experts gut the talk within for have treating about we will as we FILLY make work patients. sure of expect comes so people about hope seeing the us and we have payers, want value super-super outside We've XX% it to U.S. seen naturally we gravitate say to we'll to same towards make We mean as sure is

So you're definitely analysis but market. on come more to the with spot of your access

Matthew Luchini

All right much. you very thank

Cedric Francois

Matthew. you Thank

Operator

Thank you.

Needham next Joseph Our question Stringer & Company. from of with comes the line

Your now line is open.

Joseph Stringer

us into help scenario label maybe another sort maybe those guess questions. I scenarios understand a gap would that a be of patients try favorable PNH between on one the types and the most a you. potential what How can't context us our of help details potential and would of of taking label maybe I'll least in you for of type if two big on or difference? it scenarios? favorable put Thank of speak be is on that two the those terms understand number or Thanks

Cedric Francois

in you time much this the we're Again are we on Thank since Yes. so label PDUFA. point at away Joe. weeks commenting not two from only

Joseph Stringer

Okay.

Cedric Francois

happy to speak very about are that. We

Joseph Stringer

Fair our Thanks taking enough. for Okay. question.

Cedric Francois

you. Thank

Operator

Thank you.

line comes next Our a from of [Indiscernible]. question

now Your open. line is

Unidentified Analyst

on taking going the need how use Adam so and Kind with you for comment ease will think early is on of much feedback much question getting Starting of following for this PNH afternoon. the patients education education how thanks the approval? you could administration? Hi, sub-q any you're

Adam Townsend

Yes. Colin. question. Great Thank you

of couple with So comes sure approach. make patients we're that robust to PNH support going make obviously we've and model patient that their that launch we services a sure patient to understand for service very interacting to and we needs the been with last it when months

have so. call have to incredibly educate sure at we're we Apellis people be we that help any can footprint need PNH them also we looking and forward is support again that about to methods found amplified believe there they might actually but their very we're I can have that scenario ability with as COVID to some where we PNH patients also about doing patients. much a found support through as that through will very to need the well interactions treatment to make responded great we administration allowed the patients the administration One care thing we said and unmet with that that the treatment So that will and educators we virtual good home interactions face-to-face well our and has

Unidentified Analyst

play to recent patients OAKS XX out then to months continued will the unblinded out readout? or Just DERBY, just in wonder how procedurally see to study And that just data. the the be blinded thinking you'd Great. data and to on strengthen about all and XX-month randomized XX the Xb of if Thanks. phase up at able be months phase those remain will X

Cedric Francois

you I stay will Thank something don't if to who Federico, you Patients them? know want to add randomized, Colin.

Federico Grossi

That answer. think is the I simple Yes.

patient way then the will mask schedule continue randomize double months. the continue and the study to So will all to and XX be

Unidentified Analyst

Great. Thanks.

Operator

you. Thank

Our next of Wedbush Securities. question Chico with comes Laura from the line

Your line is now open.

Laura Chico

the the prep Thanks what missed expanded patients pretty for U.S.? curious around is taking thought question. very actually the are what much just present the and the helpful of I'm was those sorry of access size Adam but launch commentary and I within if program I it proportion at

Adam Townsend

Thanks Laura access program Grossi. Federico question. Dr. to for over the actually I'll hand the expanded

Cedric Francois

metrics FDA access program and commenting PDUFA expanded don't medical commercial need program reviewed is by pegcetacoplan close our to further access open early higher this or the we not is to we're in the any now our help Well to to affect revenue being the for the is patients We program. application FDA. the U.S. in the expect with receive while drug or our

Laura Chico

so. that or third run two a contract there for of or endpoint the that reading backdrop out just the runway and extend could either a bit bit OAKS against do DERBY quarter Okay second runway on that's little levers the question towards think then if point wondering continues more XX. could you of elaborate the into XX-Q just I'm helpful. other cash the latest I one Maybe half and the XX the years primary studies to

So that the might after just the readout understand how in studies change be should XX primary about or spend the that. how XQ thinking and Thanks. we trying to of so

Cedric Francois

want you Laura. Tim that? to Thank do take you,

Timothy Sullivan

great calculation up around because a actually cash studies built wherein moved forward success to in Laura. other and a launch contemplates intravitreally. GA also our we related capabilities pegcetacoplan that scenario Yes that's question Thanks runway Sure. global

quite were be the bit to extended calculation different runway not GA beyond forward were would a if cash we very not and our ultimately So becomes that. successful move and to get

perform Aside PNH things launch our how that we to in relate commercial in the much. typical of pretty terms from

question. your that hope answers So

Laura Chico

guys. Thanks

Cedric Francois

much Thank you so Laura.

Operator

you. Thank

Cedric Francois

forward year you as joining in ahead PNH again call. us leadership we first and our you thank much our continue look conference for to so PDUFA to are transformational our we today. complement. on We Apellis excited us Well, quarter all global the about joining for build date for Thank May and XXth

Operator

Ladies and your gentlemen this Thank participation. concludes today's call. you conference for

You now disconnect. may

We use cookies on this site to provide a more responsive and personalized service. Continuing to browse, clicking I Agree, or closing this banner indicates agreement. See our Cookie Policy for more information.