Apellis Pharmaceuticals (APLS) 31 Jul 232023 Q2 Earnings call transcript

Company Profile

Participants

Dr. Cedric Francois	Co-Founder and CEO
Tim Sullivan	CFO
Adam Townsend	CCO
Dr. Caroline Baumal	CMO
Meredith Kaya	SVP, IR
Jonathan Miller	Evercore ISI
Tazeen Ahmad	Bank of America
Anupam Rama	JPMorgan
Colleen Kusy	Robert W. Baird
Yigal Nochomovitz	Citigroup
Steven Seedhouse	Raymond James
Phil Nadeau	TD Cowen
Justin Kim	Oppenheimer & Company
Eliana Merle	UBS
Annabel Samimy	Stifel Financial Corp.
Joseph Stringer	Needham & Company
Douglas Tsao	H.C. Wainwright
Laura Chico	Wedbush Securities

Call transcript

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Operator

Good day, and thank you for standing by. Welcome to Apellis Pharmaceuticals Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]. today’s being that advised be conference recorded. is Please

the to go your now like today, over hand to Please I’d speaker conference Meredith ahead. Kaya.

Meredith Kaya

Earlier results our and joining to results. take morning, you you this Q&A happy today. morning, on session. from these Good We'll be we the quarter second thank reported questions XXXX in financial us for

the today meeting, However, Chief Baumal; and we'll Caroline comprehensive rare ASRS feedback annual Chief and from on are update including events. Sullivan. the review be Adam Cedric Dr. focusing Executive Co-Founder safety of Chief on our me Officer, With and Townsend; Financial the SYFOVRE, Commercial Officer, Officer, prepared Officer, our an remarks Francois; on call Medical recent Dr. Chief Tim

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

call to turn the over I’ll Cedric. Now,

Dr. Cedric Francois

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

before as rare have of and you going Meredith on comments. of call As a do, many we on and we me focus we questions, But events have let best seen we the answer different them the our are take vasculitis with to today's SYFOVRE. discussion provide know approach some said, to we We can. do overarching will as

again, has incredible have Apellis and of weeks resilience. been the team. team never The be shown once few I been have part and First, past challenging, dedication to prouder the

the vials And demonstrating positive United lives in including across for reported a of $XX physicians, a had of we XX,XXX reduction of long-term Data demonstrate of effects With of a as important and million quarter. These between with of SYFOVRE, GA. patients We increasing impact strength strengthening product compared sham. SYFOVRE now time. third, to treatment sales, on nonsubfoveal to $XX SYFOVRE having XX tens early of projected launch. to distributed over our lesion thousands in than XX% from growth SYFOVRE strong incredible is understanding further SYFOVRE our this total States. showed an findings, more million months to as XX GALE study Second, for approximately GA continues patients the second the extension are up

is we that, With the safety physicians our into deeply and care discussion. let's get priority, who for the Patient us. on top rely

and them the clinical in rare the investigation very do is zero know, never a may that of our singular may action. with events do comprehensive vasculitis, seriously. are disease real and drug new events reported yet, and within retina however, What a It been is it cause. these working into a identify but the of events the the studies. take causes a We new of not have events a conducting we closely not world, that potential unexpected very SYFOVRE that newly is a realistically, We into drug when know expected bringing emerge we cause that launched were in is mechanism we community. sporadic,

let's some questions. into Now, your get of

Caroline I this. these First, so we visual will to Caroline? events patients? for what outcomes about about know these it do speak hand what the far and to are over

Dr. Caroline Baumal

Cedric. you, Thank

providing the reiterate the to they physicians information patients. into said. events. safety what been recognize their I the the want along details, have best will always Patient rare these with get physicians I for patients we but to is priority, Cedric who make need and by top has been As impacted serious our decisions and with

rare. been Let Overall, these today. know share what have events we me

two event one is June. our April, have increased additional we the after practices. in in There injection. all been and have We based being and More XX,XXX in events of injections and reported by on month, May those in Apellis. evaluated drug confirmed physician patients. events to to These been injections administration following days increase reported seven of two was And the Apellis occurred corresponding This important first sporadically. between seven and vasculitis number is were to research, a occurred each than events in SYFOVRE launch of events. over event distributed number estimate three as because following March, XX there since not administered vials cases have the of Each our XX,XXX happened

on than that Saturday reported make from recognize directly ASRS. presented based physician receive review and we we following by retina determinations treating we is the the the the on external and information We by different numbers are This uveitis that numbers because specialists. slightly

we careful physician regarding what in Given must confidentiality, we information. share be detailed patient

Additionally, are interpret. these cases are to highly complex sometimes and difficult

up evaluate to we these how of event events sure potentially nearly can to treatments, loss. Of lead to better forward. inflammatory are early vision the Two have vision ASRS have outcomes reported With and patients baseline. date, confirmed of the severe is to make three vision too resolved, standard and are be to each will aligned back us recover, we for two Retina that to recovered definition to vasculitis closely still hope by going severe but a of However, are evolving. few we a with each still unlikely It to care are know this patients. patients impairment these seven take we significant working in can is months.

returned vision patient's we very closely. the monitoring patients with physicians, these case, of to baseline. suspected one has each are Working the already the For

Dr. Cedric Francois

these we to Caroline. we happening. find is What next the do and far? Thank events you, The cause what are so doing are why question know

Dr. Caroline Baumal

collaborating contributing important understand better factors these the really have potential and are These events. community with retina questions, been the we to to

is study. are trials. robust by for the all of imaging the in clinical reviewed and clinical we was from the a center. why investigator by evaluating we questions process in mass independent trial There One a first this assessed see study is Patients safety not reading the ourselves asked did a

administered zero SYFOVRE been in upon studies reports findings, to nothing our reported. X vasculitis events. events injections make our sure XX,XXX more Following confirm is Phase re-reviewed vasculitis case of receiving back missed. data and To did these we cases date, occlusion, these vascular to things one that go of inflammation have first the retina We was confirmed to intraocular no than all of and

the ischemic panel no there optic retina that were re-review well inflammation events. events, asked specialists vasculitis uveitis our neuropathy all severe neuro-ophthalmologists confirmed further to as and we to Additionally, two whom both leading events, re-review intraocular of as of

evidence these from there drug-related no events between that IOI unlikely know an to trials are product to any response clinical antibodies, to of our indication that correlation in showed changes the also caused by We no supply. peptide immune between our as anti-drug and and the to of important was there immunogenicity. providing no be were were the Data either These clinical or glycol. investigation findings polyethylene formulation commercial events

Dr. Cedric Francois

you, Caroline. Thank

are did trials, a anything So, cause? we if looking else not clinical potential see we in then as into the what

Dr. Caroline Baumal

of products significantly biologic implicated. issues and related CX events SYFOVRE clarify, contamination or been drug the To been manufacturing may are found. injection. vasculitis due into and specifically and peptide endotoxins a Levels important threshold clinical biologic. no to than SYFOVRE we a next that the that lower indication not was intraocular No identified to commercial expectation looked dosage reporting endotoxin such forms have inflammation, around events. is CXb. were SYFOVRE some there these issues as manufacturing FDA's and for for the a and lot is being The ophthalmic to of was There contributed synthetic drug endotoxins. It confusion binds manufacturing were is no processes all quality, quality and in that batches has to single these No area and

investigate into characteristics, today. have these potential are As from as factors. evaluating the don't well to for We trials contributing else, what answers real includes This we world. variations any looking patient on continuing any as clinical to

Dr. Cedric Francois

Thanks again, Caroline.

over and the treatment Adam the from and past might going this been Okay, investigation, turn share turn the of retina Caroline, talked to hearing what now and how why start then weeks, you're ASRS. forward. few to community course mean here we've the that you to what have with about for at conversations both physicians over don't let's specifically

Dr. Caroline Baumal

Sure. Thanks, Cedric.

Since physician practices Over out these the perception understand the have past and as are been some the I will to better with was deeply far. community, did of Adam better of two first early share, experiences in date, physician and total their understand also conducted SYFOVRE weeks, Upon with These engaged to we SYFOVRE injections who administered hearing multiple events, physicians to to have research thousands of and vasculitis. specialists so market thing and reach impact. have of past talk in field, dozens spent meeting are just leading of not they the and to think ASRS to retina Seattle. are eager any treatment. in cases Overall, These have seen experts days four we take events, this continued data. and the hundreds time understand and for with then, our at how safety more need will more about serious physicians to physicians information, with

to my As risks when with decisions to experts it therapies, communicate patients. that in They're can injections. the colleagues patients, attest especially can benefit profile effectively are they physician, treating associated a thoughtful I intravitreal make, comes their with these understand that and retina the the risk their

share a what to bit also team he hearing. and of turn are over I'll to it Adam his

Adam Townsend

in Thanks, amount doctors and past commercial then engaging Caroline, and spent has weekend good at person few with an ASRS. also of enormous over everyone. this the time The team retina weeks, morning,

that and is have. to questions quickly sure any priority to we physicians with answer available are as one are number Our them can, we know we information make as they that that sharing

we ASRS, we and these Following context field Caroline with getting spoke earlier. with have communication about feedback color The the to is our and calls very communications speakers. two member numerous additional the what physicians, held our physicians sent and consistent sharing events, from from are to

new we doctors patients, until pause existing third have in many specialists, prior patients whom said key some and prior in the third on existing market plan third retina this, next in more they as early were the the treatment. and they with in information. survey near remaining they one we but both this had events said SYFOVRE of with meeting, treatment The treating had their to more Additionally, sales vasculitis patients. patients research seek pause of SYFOVRE. Based until to continue to the using new may plan US The conducted anticipate plan as doctors experience survey information said term to using they and that of to they request do the previous gain to their been of use SYFOVRE ASRS most continue or patients, takeaways some bumpiness

months. very few to next Our believe important of to job these bring GA We is ready to partner a people this thoughtful, transparent latter. bring to the to soon. treatment this be US patients continue it worldwide in be the quick millions to on A update the from is over to and suffering

applications starting in Our decision back are in marketing we and early XXXX. you. hand Cedric, worldwide, multiple EU, approval to I'll under it territories including that, expect review the With

Dr. Cedric Francois

Adam. you, Thank

Okay.

Another cash question our course, events SYFOVRE how comment on will these thinking impact of we everyone's mind sales how you we financing this? point? think Tim, are rare runway, at this can and is about and on ultimately,

Tim Sullivan

course. Of Thanks, Cedric.

assumptions, XXXX. had quarter $XXX runway million second on Based provides of a in our the us of first with current quarter, the we cash. into As this

is near know the it However, we the in safety trajectory may these term, but magnitude. very don't because events impact the all sales new,

monitoring parallel, at are looking forward. closely ensure being our and and overall spend we are demand to going thoughtful We in very disciplined

but of have transparent be don't all you, we today. the details will you We for with

not to we financing, pressure are any raise immediate for As under money.

at always in with we will and we mind. ways the which in time evaluate finance our multiple the company right As do, to shareholders

Dr. Cedric Francois

just give the some not data long-term Thank about the onto also safety weekend, us us was this extension about we shared? for new then, overview study. last data our presented can some you, from you an because the Tim, that question new ASRS please GALE of exciting Caroline, was

Dr. Caroline Baumal

that These patients strong arm. a GA time first nonsubfoveal of most This from to the XX% with were projected as and demonstrated lesion GA reduced means to within XX we Cedric presence as presentations. seeing with monthly earlier. reinforcing large, reduced lesions shared months absolutely. long-term years, XX% ASRS for growth seven of What compared this effects patients safety this rate was and reported SYFOVRE and XX three arm. Thanks, weekend, half. Notably, the efficacy we that we in mentioned lesion arm have The Yes, GALE were nonsubfoveal the data. monthly GA seen nonsubfoveal extension about at had months Between We growth level flowing SYFOVRE. data Cedric. Phase podium up by the of study our GA lesion XX, the between progression the in by are at in safety slow excited XX SYFOVRE sham the by study. time X in first consistent previously profiling a seen growth GALE the nearly is with This well-controlled GA data

addition help the data disease. using of to of and days, protect these are with significantly also presented contribute irreversible initiation In we visual effect the photoreceptor the upon Photoreceptor data, photoreceptor SYFOVRE additional to SYFOVRE cells against past AI and importance few are dataset reinforce reduced GALE shared demonstrating to data, and the the robust for with this in along photoreceptor treatment these cells GALE degeneration. Both to treatment. protecting of SYFOVRE acuity, most responsible analysis against over technology cell the degradation the of GA,

to for I'll turn closing remarks. it back over Cedric

Dr. Cedric Francois

Thank you, Caroline.

excited We data presented the at ASRS. are very about

Although a we been it we a have turbulent ahead has of strong us. few believe future that weeks,

We on formally we'll quarterly of on and update of rate monitoring our events the the calls. closely SYFOVRE are real world, in safety the

we be team, with and patients is and not need right Blazing SYFOVRE bringing intend is future transparency on what our physicians, We investors. cases. utmost and am in new Apellis to not in atrophy patients, worldwide. confident to the situation this to integrity I commenting forward individual but will trail We for a geographic easy, in and handle look do the

are We is the with proud having patients PNH. impact also EMPAVELI that on of

diseases continue we of complement and to achieve bringing lives to advance clinical by preclinical market. innovative a pipeline Additionally, robust debilitating new improving to therapies of living goal and the our with people

Let us questions. now Operator? open the call for

Operator

[Operator with first of from Umer question the Raffat Instructions] Thank Our comes line Evercore. you.

Your now line open. is

Jonathan Miller

past be Jon love confirm It's the of guys. you inventory bit were of for any from on there an shipped inventory little much how that been keeps actually on change clarity in a given channel feedback weekend. would vials may the how as I in on this XXk Hi, inventory one Umer. the much would more that doc average in hearing furthermore, have we of out Can Then to at ASRS and bit device. a is that trial commercial time? stock

that SYFOVRE have that this and docs there draw-up is challenging, of vial a different little had draw-up obviously supplier trials the from for So, that's a is automatic Commercial product. the bit the solution? been complaining for

into? So, is that something that could be driving this or something you've looked

Dr. Cedric Francois

Thank and second you, over Adam hand the I will question Jon. the take one. to then first

Adam Townsend

Jon. Hi, Adam. It's

our So, vials, prescribers hold they average, contacted worth And yes, fridges. of those top XX,XXX our discussions, of within been inventory the and physician we to on a practices. distributed those top us approximately after prescribers, their week's tell have

the fridges. So, majority vast with in used vials XX,XXX being of likely patients. not those are sitting probably They're

Cedric. held week to back then a and hand about first a that average on in answers part, refrigerator. Hopefully I'll the So,

Dr. Cedric Francois

Adam. you, Thank

of couple time, the we objective nature. and so, important And think sporadic are over and weekend They’re large as all, problem? that weekend closely happening they to we what's increase of time, events to we this what very work can mentioned there have did in of is that get had we I sense Jon, and of good these coming with that is that and rare. research weeks was, is past ASRS, here, And over this changing that objective Is ASRS that rate first very in the right? don't something missed? Caroline this conclude So, key secondly, right? i.e., nationwide, an how earlier, a this the very And important is

course, you Then what behind world. important. And question, potential different the was etiology clinical of really and the comes imagine, is really, is as starting of that course, in best the real versus point can trials the is think the as this? mentioned, what I you

data, hypothesizing product patients. We we owe until and that are was the first answer we to to trials? used That are physicians engage the yes. something in we is we that same out. and In and the are we drug that be to the is think physicians product to going very clinical is I drug really to in delivering have investigation, not is the find as going important. the that methodical, that to step today, And

steps now evaluate going only played next have We those will to have clarity. when we other take to are that factors could role, communicate but on we more

Jonathan Miller

any like syringes, talking is like not that. of about additional So, vial same, you the the drug devices, say of that product the materials necessarily things with drop come specifically drug may when along assisting have the you're

Dr. Cedric Francois

of part All will be of investigation. our these

Jonathan Miller

All right. Thank much. you very

Operator

Thank you.

from comes of Bank with America. question next of Our Ahmad Tazeen line the

line now Your is open.

Tazeen Ahmad

Hi. I wanted to for some taking guys. remarks. your clarify morning, my Thanks Good prepared upon questions. of Also,

basis, because are Maybe about So, risk benefit forward. think so what go-forward a mitigation on Cedric, docs Adam, from about far, appropriate you guidance talked from is the going this how probably plan? would I thinking but Adam a for company you've done you've

so, are out? cases Secondly, all specialists that injected And retina or follow-up. plan And the by reported a to I vasculitis then I by of were of in of you have done were were general ASRS, to where ophthalmologists? were trying them that to any clarify, wanted they

Dr. Cedric Francois

Tazeen. much, so you Thank

that is distributing we way of guidance, the So, this we of a mitigation we, on want to using product. docs And that course, closely clinical that and all, have stick something in and this really it of product risk evaluated possible. as as thoroughly have is I - we briefly important have label, first think of to that that here a trials

the do to communicated thorough. so we of them, letters with through make physicians continue to have update are that sure communication We and routes will to

the ASRS. We will with continue to work

going retina to to should it steps, right, community with are relates et be how cetera, is but this the better community, working anyone, talk as be mitigation the positioned than far retina we to about practice As handled.

important think hands communicate community. our get to the ASRS with we the fact and on to the that nature sporadic this wanted I the rate weekend to most that and again, to understand was

cases Yes. So, is The vasculitis I done were doctors. think but is look important. reported believe by will all I that really correct. that Caroline, That retina were all to I

Tazeen Ahmad

that Okay, ASRS that think thanks. occurred confirmed that case a after SYFOVRE said I suspected And then second injection. the been there's maybe hasn't been lastly,

had that the you past you, more was this over little patient's characteristics? particular the not about but think I bit have a learn reported opportunity weekend, to to

Dr. Cedric Francois

it's of point the science, right? to that are is key right, the But there thing a kind that few in after really factors realizing ago, where I hidden suspected important not exact many are an think here out that nationwide, close a right, of all Yes, confounding up sudden that right? cases a weeks ended for this. suspected were was - This reason, we came into come we tsunami we sense that are is that to way. like we a thorough a very our search that not There

So, be new in there cases. likelihood, all will,

evaluate We those and those. will take

will to rates can work about the these their and nature creates events physicians openly communicate that sporadic a We with with the but ASRS, knowledge the of continue patients. that benefit then with risk profile

Tazeen Ahmad

Cedric. Okay. Thanks,

Operator

Thank you.

the Anupam next line comes question Rama with Our JPMorgan. from of

now is open. line Your

Anupam Rama

the question. segmented how question Hey for the guys, thanks so taking Maybe on you physicians. much a

what give as amongst So, a to you've where seen prescribe, these third top sense remaining sort to who physicians continue you the to are of maybe of us prescribers your fall of you've one date? into to that can going physicians talked

Dr. Cedric Francois

Adam?

Adam Townsend

absolutely. Yes,

mix. yes, actually of a research, our the be to tend market So, third so they one

accounts, accounts. but top So, they're prescribers, they're large of a our smaller slightly also mix

market between users within patients. XXX research and the SYFOVRE had So, our one

prior use tell a can research SYFOVRE market that we that ASRS. you broad did to bolus there snapshot within there's So, of

usage tend and accounts large we across the as smaller well. to PE-backed So, get accounts

So, consistent in was our market within that third. that research,

Anupam Rama

so Thanks question. much our for taking

Operator

you. Thank

question comes next Kusy of Colleen the Our line from with Baird.

line open. Your is now

Colleen Kusy

and morning, thanks Thanks. our questions. Good for taking

market? is Are syringe for take in there bring commercial any the prefilled how similar to So, long feedback any we've developing progress a progress to heard would SYFOVRE, there - on needle made potentially kit. on and the that

Dr. Cedric Francois

you thank Colleen. Yes,

the of as prefilled course, around is that a again, mentioned was unfortunately an the Eylea earlier, well. part for is the the important That our of of overall It as occurred investigation us. as takes development, and and ancillaries events several case for investigation, as something was years So, well. objective Lucentis as syringe before

that, in expect near but that that We future. are is working very you something should not hard the towards

Colleen Kusy

thank helpful, you. And That's a follow-up.

can up? be one case would come future in of be the at encouragingly. guidance Anything the for about best that that notable on did patient's least if think these So, treatment future? how vision the recover think cases you Any applied you cases

Dr. Cedric Francois

Caroline?

Dr. Caroline Baumal

Thank you.

complex, in and are earlier evolution. is presented patients about that of and update when rare back still difficult them so but to talk we guidelines present, in three I that retina to nearly I the vision with As make these this will baseline, continue would are to and the the at treatment two we recovered cases it's guidance. interpretation cases communicate any some have What community have say

Colleen Kusy

you submitted Thank last just Europe, be do have to one review? And cases to European us, of and expect regulators, part that you. the vasculitis in these you from

Dr. Cedric Francois

We Of safety the events communicate to all regulatory authorities. course. all

Colleen Kusy

Thanks that for Great. questions. taking

Operator

Thank you.

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

line open. is Your

Yigal Nochomovitz

team. the and Cedric, for question. taking Hi Thanks

was before conducted conducted, On that market research you the the ASRS. mentioned survey you

detailed the the of the case just to the the on survey letter that was aspects you mid-July, any or from contents were Thanks. the on were there with presented retinal Saturday? physicians, given presented So, of images studies ASRS they further just or to details when that either based respect

Dr. Cedric Francois

Good you, hearing Yigal. Thank you. Adam?

Adam Townsend

Yes, Yigal. hi,

was the survey, did letter we for basis only as that. used with the the ASRS we from what So,

Yigal Nochomovitz

are saying that mean, the the of apply of excipients drug thanks. the manufacturing then or inhibition? mechanism of manufacturing aspects or the of and were manufacturing, underlying just the you CX that very with any to way the other of itself? product the mode on action necessarily produced SYFOVRE drug action process, but potential Or around just does Okay, excludes respect not specific And being product to statement I

Dr. Cedric Francois

mode the was investigation, of broader be world. action mode of of is the clinical as Yes, trials, the action but was in the to again, in the it course, going of part the same real so

All we date, same as the say all was specs trials product within distributing product we same So, the to same and no manufacturing is can clinical that answers there manufactured and process. used in is are the that the that to the again, product the physicians yet.

Yigal Nochomovitz

disease Okay. pursue may Is And all the the least or you a way these to can than and conditions be Caroline are are then demographics I slide conditions know all GA? terms there to a having and divergent, mentioned these obviously GA. cases, at don't pursue, going highly I of hypothesis I you're complex in commonality that highly of anything other in or highly commonality few think saw other than ASRS times, no a any say, hypothesis clear other that any or potential just complex comorbidities

Dr. Cedric Francois

Yigal. something - that of patients between you, kind much These trying Thank cases a requires require find larger are as that to so would can rare commonalities imagine, numerator. you

and track to will be we to investigate, we're is exclude able have but be rest to The continue So, manufacturing. going subject to all to it continue done now further research. right

Yigal Nochomovitz

Cedric. Thanks, Okay.

Operator

you. Thank

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

now line open. Your is

Steven Seedhouse

have for for Thanks the then questions. one a I Caroline, morning. commercial if and taking could. the I Good follow-up

if today to July. X,XXX, so back we number that quarter, letter were say and have half and weeks on well, vials ASRS July second offices now then in Some distributed, July two like have first would updating July XQ of XX,XXX of of X,XXX the XX,XXX vials distributed in distributed X,XXX the the July let's XX,XXX implies as as XXth. the on out that you're per in second well, XXth we that XXst, - or which we as imply the like implies That the enhanced, numbers XX,XXX of

about it So, sales appreciate of the but mean, the just vials you can said had half number work that I distributed. math? and some impact you same does of July really expect survey second first like corroborate suggests the half certainly that and look you the I that,

Dr. Cedric Francois

Steve. Thank you, Adam?

Adam Townsend

Hi, Steve. Yes.

weekend. the and I one to this right, week is about the - think math week think gone, current ASRS your week this but obviously sorry, is and just is thing

Seattle. So, a were lot in of physicians here here, or are actually

So, bumpiness explained. vials But we have conferences. attend calendarize some of couple for are always as your throughout orders continuing as and tend weeks, the physicians this these math continued the for last to week

Steven Seedhouse

because seemed during the thanks. and wasn't especially some that Vancomycin, for is Okay, for necessarily optimal vasculitis, Caroline, discussion clinical inject, that retinal it just that presentation ASRS Saturday study. is intraocular management like which early on a possibility. is on And something I a of it might the mitigate in been tap for think hadn't approach worst observed experience, especially maybe on the And if there the some could based be panel now be known steroids, better of to and this outcomes instance, not suspected, an approach

be could this on future? accurate So, forward in basis you Thanks. improved just think alone do that outcomes going is happens and if that visual the characterization

Dr. Caroline Baumal

said commonality. as before, not and these Well, that by all cases bound I for they're question, thank are complex and you

with think our I retina we cases. these have management learn of to colleagues more on

Steven Seedhouse

Thanks. Great.

Operator

Thank you.

TD Cowen. question of with Nadeau comes the Our line Phil next from

now open. is line Your

Phil Nadeau

Good A questions. from morning. us. for couple taking our Thanks

was were you the basis not more the bit for that on can of conclude manufacturing performed First conclusion, involved, to manufacturing conclusion what a what an that you discuss analysis and do did issue? assays is generally

Dr. Cedric Francois

Phil. Thank Yes. you

was no. and investigations through work way that and involved get start the one right? to around through So, are has manufacturing specifically cases. lots specs whether these the our the looking that quite a as go our related find was within into to of specific then know, of look you these to answer manufacturing out process shipped introduction well was where testing by problem these cases all investigated And the NDA, not evaluating batches standardized, whether to was actually So, CMC the that the were predefined product We and much group of are in drug the possibility all registrational that a more in then lot.

Phil Nadeau

had that as at that it supplier think associated the to about up out did You something innocuous. they where that changed would picked Eprex seemed the If situation the case turned look potential Eprex cell like years situation red have been you ago stoppers, XX and was supply the the rubber totally manufacturing here, a I may same and of they with be Are that recall detailed? analysis to aplasia, cause?

Dr. Cedric Francois

we was trials Yes, would've the clinical in now in how product if change did terms what we in world, the the what there a real between you. we we do told and of manufacture

the our all same is this use the used that and specs clinical we in same trials within as So, the process manufacturing well. and same

Phil Nadeau

naïve And to a estimates vasculitis? at per any ASRS therapy? wondering you the to questions same as some the so, on on what after the risk happen then were per patient And there be Physicians the since seems of question, it going naïve of how patients physicians incident what are is would therapy? dose. patient first on Perfect. were from Do patient many incidence a have getting patient the

Dr. Cedric Francois

Yes, course, that It’s that. thank for to you look something so much question, early, very into Phil. of like

the patients. probably estimated of going probably majority first first to, been have time these in will XX,XXX injections the real are world course, time in Of or injections

the lot rare this out, increased a in right? of bear this a which extremely whether from know an instance physicians. I it the that community event is don't phenomenon, And of sensitizing and of an first think work. product that going over just to we introduced, is than that, So, kind came subsequent is where right? woodworks nature, not is through that fact huge sporadic a injection to yet was other place, and that's and more denominator mean, is that it's here. more the retina provides event And ran is a find a mind course, of we're years very patients really in injections, now time where a event absolutely That happening product was ago out what traumatizing an where couple and important was to patients taking I

it's So, I that to think categorically. important state

Phil Nadeau

us. from question Last

cause next either on on does forward, the or path when In disclosure analysis terms update or going of its on providing vasculitis? analysis information root a provide cases, have ASRS you do of of Apellis incidents timelines any an could the have your to any

Dr. Cedric Francois

Yes.

to as to we when things And quarterly on we're a So, not we going as investigation that And understanding tell, are make we're the real an very around relates grateful to So, update rates. we going have will to the right? we it have updates update to and mentioned, have to with for with provide the we partnership clarity going work this. provide unless continue ASRS, are we we them.

Phil Nadeau

Thanks for questions. taking Great. our

Operator

you. Thank

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

line Your now open. is

Justin Kim

questions. gears a bit Hi, taking good GALE. shifting towards morning. Thanks Maybe for the little

on, events and safety really on are continuing Just you've clinical context the wondering of over subgroups aren't study. GALE that of the participation in just given for being those increasing study patient US sort delivering how those in observed the is and in these that effects especially the showing time, given terms the feedback of heard whether in events clinical

Dr. Cedric Francois

much question, Yes, for Justin. so thank you that

was DERBY very OAKS first and to extension as, as that in the this into all went Approximately of the of GALE from XX% of study. So, go high, patients three-year into decided right? recall, may number trial patients you the

has from already who GALE think actually, having away the years for treatment the months We with patient on are study. been SYFOVRE five first I in

not the to database as rich important understand just efficacy. an mentioned, the So, but for us you incredibly also safety, and

benefit, have those this, the As and recognize with to patients so mentioned reminder familiar earlier, that objects progression by of Caroline and important. GA is of XX% patient of have their of And all read something course with being patients are with ability not course take that a we vision, will which lesions, to with the for which safety their central these vision, periphery have it's the really to if investigate. typically very good other still you disease in looks extrafoveal things, of who are that seriously, a we these a with in as down slow incredibly like able words, these close events, can we

think, to for profile evolving to. patients look On forward exciting, I also the something flip side, is the and very efficacy

Operator

you. Thank

next of Our Archila line Wells Fargo. from question comes Derek with the

Your open. line is

Derek Archila

questions. for Hey, and thanks the good morning taking

do retinal been commonalities on patients would label if docs language between has Thanks. patients that the two deter suited future doing in But said end could but us haven't just these you how to injections - the is, the I vasculitis direct just can ASRS no determined. us. happening? up - may first off, both bilateral from docs for similarities you something present experiencing you eyes? disease? expect guess, Just know there investigation, then I from would best with many ultimately still notification you're you or are I And think And remind also, that patients who Is therapy? working that

Dr. Cedric Francois

Thank you, Derek.

too It with Let question. talk second the start about way me early to that. is

the close we available. with evaluate potentially is obviously these do in on all communication of are That things. information something when that is very more We FDA and will

to Caroline, relates bilateral patients, you it maybe As speak could that. to

Dr. Caroline Baumal

Thank Cedric. you,

they treatment they new with And paradigm. may present typically be case. that I that injections first that - do. retina present it bilateral that think are And that And we include bilateral product, is our in consider when do time does did who one highlight unilateral what use. did very a ASRS case physicians however, As we injection to in have prudent thoughtful

Derek Archila

you Thank much. you. Got so

Operator

Thank you.

next the from line comes Eliana question with of Merle Our UBS.

line is now Your open.

Eliana Merle

to findings the administration Thanks What's the say, in materials, then understanding you those maybe using or syringe your the for were physicians you to given to, way submitted also injection a provided the different the the just any safety taking the of the if of or deviate in for any so procedures? administration from And EMA. proper question. alluded all choose use, much did cases

that Just on any from so color those far Thanks. interactions?

Dr. Cedric Francois

Thank you so Eliana. much,

the very is butter professional the right? fortunate heart is here that years again, or important note and experienced bread these XX and with think and I retina practices intravitreal are for that it's So, community the the so mean, last injections, I of we this to so.

So, have will before, that is when and be that Syringes, we be information. of comment broader on that remembered our investigation, will something more part needs we here. as to ancillaries, mentioned

course, the mentioned, it becomes these well. with It so everything relates of going I to That as EMA, evaluation far has been to agencies. we EMA communicate, As part evaluation. of the

see So, for now, changes. we don't any

Eliana Merle

guess just if follow didn't those any I And patients Thanks. In on fully they impacts recovered? IOI vasculitis, a up. color cases vision any have did the that had who Great. and retinal have quick Thanks.

Dr. Cedric Francois

a think, important that way IOI the other. very Intraocular with Eli, there that in with is slide presented, saw in the or is are and bit what the trials what in of cases trials a clinical was I world is rates have inflammation line injections Yes, seen the a and intravitreal general. normal with question, each saw and that with you misconception we inflammation injections, because with very confusable with vasculitis the anti-VEGF of and in would in we what intraocular real our we see are

have these on kind which no that course, our end, like we concerns. vasculitis, severe of severe look they draw of So, of cases inflammation that are complication a attention. do special It's, of

there. So, vasculitis I a important IOI you don't if think to an much that's I typically better recovery. cases difference like something. without Caroline, know, have would add

Dr. Caroline Baumal

We've that the real looked of seen reported is we've into single consistent And that case the rates into clinical IOI we're every world in with looking the study. - to are us.

Eliana Merle

so Thanks guys. Great. much,

Operator

Thank you.

the from Stifel. comes Samimy Annabel with line of question next Our

Your line is open. now

Annabel Samimy

being where anything methods you treatment And didn't gather the versus can they that of I I going just that you in my methods back from to real anything was you from that protocols retinal the what see these assess in done of obviously kind plan that risk develop cases better physicians vasculitis. - mitigation guess, world in some any are forward? to, kind they trials the can some were of way of or right patients clinical trials used go real the to can now Is assessing the taking that thanks in there question. that patient versus are for clinical used sense wanted Hi, for world. a

Dr. Cedric Francois

Yes, thank you, Annabel.

we probably than something as as mentioned is in we important process, But desire to understand that anyone, anyone, are be as have strong much it to very to is before, to. more look, that dedicated very try a So, methodical which this.

be. about don't So, want we comment what could to

We will it. are have going we when to and more look share into information, everything, we

many communicate into Of every it time. drugs and world, able is these and at right, take front, are from as unfortunate, that that findings as a It where properly. on into sponsor, a there will run us evaluate and real to diligent, them works, real point on unique, the these again, comment, being is cases company, trials they unexpected different how much be and general all when to not the clinical right, which it the in to on understand is is variability course, seriously, them more go to signals, world at but it's

Annabel Samimy

what cases versus far what them? as what ASRS differences panel? to there, all overlap be Is different are then between And Appell and on, Great. reported the extent with these to physicians? the or reported Okay. to ASRS your of are completely overlapping panel they And as independent reviewing going getting is there at was you any sets

Dr. Cedric Francois

Yes, thank question. for you so much that

a collaborative these overlapped, right? my occlusive, partnership time. So, So, the process which again, you're now, But its process is as depending committee show is very rare that going or in you But the that cannot experts very was in each other, nature. and news thing one from up one as is ReST it much cases, the count important ballpark, here ended sporadic down the to even to non-occlusive, in about or answers, the this the this we these and point on different most from of up And we you with exact So, shared is in being and close cases thorough with same where right? and get see that cases nature slide. up here to, a are this one right? rare distribution were event, fortunately, over very is their one, we that of had to a vantage remarkably ASRS these stone wonderful to down nature, could that or case, importantly, we sporadic rate is set that you And extremely right? many

Annabel Samimy

Can of great. follow one people rarity. in and is the Beovu context? that terms if one way just And you I could I just of we to making of maybe onset just in sort that again the can up that speak maybe a this know been time put in repeat Okay, context the And the maybe more, so Beovu for comparison. us going why to more of not with have lot

Dr. Cedric Francois

you Annabel. thank Yes,

author the So, lead was that lead there. was we're very the Beovu on the Caroline the done on paper fortunate actually investigation and because work

this. to So, uniquely positioned on comment she's

Dr. Caroline Baumal

Thank you, Cedric.

contrast, Brolucizumab. our think what studies. HARRIER what I the see from all very this have features In is onset SYFOVRE with patients in rate seen was and clinical And we Also, clinical HAWK seen that we and did the in who Brolucizumab rare. differ vasculitis was the alluded are studies. you with X.X% to, at with in of as not

Annabel Samimy

Different onset? of terms when was the in

Dr. Caroline Baumal

three injections. common with having so was in the after weeks. of And multiple a four Brolucizumab the shorter their clinical onset Brolucizumab, typically of of with studies. this discontinuation And note, interval Well, time some between played with events to injections the were role more a

As clinical well, Brolucizumab exams. different of caused features on an arteritis and sorts

Annabel Samimy

Okay. Great. Thanks so much color. the for

Operator

Thank you.

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

open. now is line Your

Joseph Stringer

our taking for thanks Hi, questions.

many of how the and specifically, have Just comment have returned curious, on into you returned vials? visibility what been can More this? vials and/or vials practices returns how many have you

Dr. Cedric Francois

Adam? Joey. you, Thank

Adam Townsend

Joey. Hey Yes.

but we So, number have is returns, some the actually small. vial very seen yes,

Joseph Stringer

Thank for our taking you questions. Okay.

Operator

you. Thank

Our Wainwright. line the Douglas Tsao H.C. with of comes next from question

Your line now is open.

Douglas Tsao

Good Thanks taking Hi. questions. morning. for the

said are stopping who Just pausing anecdotal, curious you need what to just physicians and just from, the sense is they first, of got I'm patients the restart? if would the I'm third sort to are they just for do that who either curious, or but see with altogether new Adam, this in terms starts, they a market of maybe research more

Adam Townsend

question. the for thanks Yes,

couple any to positions? information pause be theme relatively patients are comes a would over and want found hear for from enough to to see pausing a This either to conversations next tends very transparent lot last new the in a a said more They the your if consistent to ASRS happens think that if quickly have within to get They right? out. I what don't physicians all weeks, the Apellis our want updates at weekend, has Caroline to within add more to to That they on ASRS their our want decided just also for They pause. So, or happened the the and that Caroline, they over way. That says important, at you the they about starts No, want be and having are ones see would research. with stability. with want see of time this weeks, research conversations have rate was of know physicians that based as same I information. have that those theme thing. anything few

So, where that's we are.

Douglas Tsao

Okay.

be to just stability, of life, they're word, so for for lack waiting cetera. coming it's et on like more cases just There woodwork, better a issue. this to to now a sort that not aren't out of has of get sense waiting seems some so Adam, the come of So, see that if as definitive some conclusion clear, more they're this to sort of

Adam Townsend

Correct

Douglas Tsao

and Correct. XX,XXX, Great. the as And of I'm not but you missed I first were how do know, think asked, answer, many maybe then the somebody I right follow sure now? just up, just injections a

Adam Townsend

the is our but know, assumption don't majority injections. We first that are vast

Douglas Tsao

or? DTC Okay, quick Winkler just Henry started just you work I pause one campaign, one. then is continuing right with great. Are know now? had the final you And or that on

Adam Townsend

great it's question. Yes, a

good patients So, impact DTC have really about to has driven has and vision. conversations had a losing

that. use we'll moving very we I thoughtful be how think forward

really have I and conversations is age. getting the vision, time their good the is DTC a check with But and certain a to all think Now patients impact thing for for go transparent of physicians. us open patients to

So, we use very in that thoughtful we'll be forward. how but work, that of moving proud I'm

Douglas Tsao

great. so much. Okay, you Thank

Operator

you. Thank

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

Your line is open. now

Laura Chico

was have I correct, have but Apellis came morning much also injection, of think ReST how kind I just a if for but taking after there. I so very just a Thanks I then question. wanted to a different Hey, there conclusion apologize to clarification I follow-up. if second missed good I And occurred clarify that the that one had question. one this, I guys. incident noted

Dr. Cedric Francois

Laura. you, thank Yes,

on look findings a was suspected that were So, that. far injections. all case. first Based We need into so to our

Laura Chico

just then back, it's evolve market the another thank How And guess, you. lean going going dosing expectation Adam, I research but you. interval are events. color. your over you what that we've with the Thank kind might way how Okay. you or is I the to encountered dosing time for interval one now of safety realize Thank terms around premature, frequency kind of these physicians in think here do SYFOVRE? of

Adam Townsend

Laura. absolutely. welcome, Yes, Yes, you're

these this a future. other and GALE gets physician and people once physicians was, segment data a moving as and rare your needs Caroline, that through assumption over see will my comfortable, and other dosing you the with majority moves, the to again, vasculitis from by And that month look as just that the I dosing. every to I every to majority. using progress expect these of want vast, the think vast monthly the perspective, type assumption, comfortable prior increasing month you'll events, confirms safety at effects I think time, of our events fluctuation this vast start for get be So, but forward. be used little every And think I anything other the to bit month the vasculitis, we were dosing vast consistent majority add? to will And be

Caroline Baumal

that's this to different thoughtful so of flexible. label having and every majority eight the And experienced are between medication. other of with preferred physicians I physicians of think that is the paradigm. weeks type all a heard dosing think things, very appreciate sorts every month but very, very six I with vast I've

Laura Chico

much, very Thanks guys.

Operator

Francois hand would conference I for to now back the closing remarks. like you. over Thank to Cedric

Dr. Cedric Francois

been, weeks because for but thank much. out very clarity. have Well, in we gained how we of It's us, you we Thank ASRS of us that joining intense closing, couple course, an significant very with are for come you we happy believe today. all of

are We of couple ready weeks. next on to the take

to investigation as transparent continue to be continue We will we as and the promise have been.

and today later tomorrow. around are We

questions, free to additional any have feel Meredith. you Thank reach If you. out to

Operator

today's you This your concludes conference Thank for call. participation.

You may now disconnect.

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