Apellis Pharmaceuticals (APLS) 4 May 232023 Q1 Earnings call transcript

Company Profile

Participants

Meredith Kaya	executive
Cedric Francois	executive
Adam Townsend	executive
Caroline Baumal	executive
Timothy Sullivan	executive
Madhu Kumar	analyst
Jonathan Miller	analyst
Tazeen Ahmad	analyst
Anupam Rama	analyst
Colleen Hanley	analyst
Yigal Nochomovitz	analyst
Steven Seedhouse	analyst
Philip Nadeau	analyst
Justin Kim	analyst
Derek Archila	analyst
Eliana Merle	analyst
Annabel Samimy	analyst
Joseph Stringer	analyst
Douglas Tsao	analyst

Call transcript

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Operator

Good day and thank you for standing by. Welcome to the Q1 2023 Apellis Pharmaceuticals Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I'd now like to hand the conference over to your speaker today, Meredith Kaya. Please go ahead.

Meredith Kaya

Good afternoon, and thank you for joining us to discuss Apellis' first quarter 2023 financial results. call and the Dr. Executive on me are Chief Co-Founder Officer, With Francois; Townsend; Adam Commercial Medical Cedric Officer, Chief Chief Officer, Dr. Chief Caroline and Financial Sullivan. Tim Baumal; Officer,

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

I'll to Now Cedric. turn the call over

Cedric Francois

incredibly product vials launched shipped sales options. SYFOVRE net for the month X. treatment until on is Meredith, treatment Thank injections. well details We so proven SYFOVRE in. was us over of to inevitably treatment that geographic culmination and XX. February of of more let a flexible period, in first-quarter. just that million over X dosing, for nearly and and that proud million disease thank alone, SYFOVRE bring and increasing with you, I a $XX.X to dedication is in launch leads generated of work the slow hard right to jump now were only vision SYFOVRE no relentlessly than patients received and approval effects safety GA, had and SYFOVRE's XX the and that atrophy are joining on profile team FDA the you all the ability everyone, following label me commercial SYFOVRE a U.S. who to first XX,XXX today. approval we more affects than for month patients years is In GA of U.S. to of physicians U.S. progression This for top-of-mind and for know X,XXX March the the SYFOVRE demonstrated first XX our by available loss. Prescribing

the as care second view expectations really leading quarter early strong longer-term has Initial eye our momentum patients by this continuing as this adoption. see to in market start professionals encouraged and well of demand. so we strong indicator both as a are We the and exceeded far by demand

this category. is that me GA by saying new uncharted temper a let However,

have market and about to may how for We the in just impact been starting months adoption are X various learn demand. trends

functional So ARVO, we anticipate and some uptick while seeing progress market, commercial periods. Caroline and March, the at on Adam are recent the we we throughout progress color temporary pleased presented with are with our provide will in in analysis our and more the J-Code what the of fluctuations launch.

making to We now Switzerland, Canada, are pegcetacoplan intravitreal in the applications under and Kingdom. efforts important in with to European also Union, review steps patients United globally, Australia, our the bring

Turning EMPAVELI. to now

for we U.S. EMPAVELI momentum EMPAVELI for EMPAVELI as quarter. were second market. PRINCE the product in who committee. of data period, or We people and caregivers we you as close-out million clear study participated data treatment like includes living with year-on this and pleased made rates have is a analyze was the see All to sales safety with testament portion will study ALS approval for to are within community. by following EMPAVELI. In study, results tough how drug as and we the the the approval net XX%. outstanding signals. not would feel based The to the II ALS injector. any the its discontinue a to What the our into continues the independent have in the of PEGASUS remain monitoring and which the thank strong to decision the their and which supplemental a the were built an We of partnerships recently with completed NDA, planned. I potential better on stand-out recommendation the to really compliance patients committee's it first view launch $XX.X we when and around continuing much the unexpected ALS, look-forward taking in treatment we its to recommendation the This far open-label patients this in randomized Phase say

science continue begun hear we forward Overall, only and advance a some with sharing to our continued to nearly of We will and progress you'll unlock it have Adam. you about these going over to preclinical and the to we turn that, just today. dozen programs, clinical believe potential more of complement forward. With I look

Adam Townsend

I that Cedric. patients are am enthusiasm showing Thank the thrilled physicians SYFOVRE. and initial with you, for

joined the on commercial medical SYFOVRE launch feedback. in for energized, Many have XX historical gain providing on have recognizing the posted the experience social call experience first-ever February, for teams into and retina. their flawless with retina shared specialists best-in-class launch patients I in and GA. our leaders as insights opportunity execution extensive operational highly and went they and and the They specialists the retina of the treatment first importance approved well-prepared X, treated us to-date. On to built their about we shown patients, As nature on day approval media, commercial an

engaged X,XXX SYFOVRE share me at territory. least were every shipped have of we vials orders and to SYFOVRE physicians. initial March. commercial seen The within with sales now metrics commercial nearly the X,XXX Let and from once, teams some medical physicians

In which demand. addition more vials, indicator to than future important to distributed of commercial is physicians request, an X,XXX we upon samples also

excellent J-Code and for We amount which our than SYFOVRE launch and receive to early have QX. a what we of seeing off academic expected. planned, to start several we in significant has encouraged faster put the private-equity institutions by we're is our A And as an expect also on seen CMS October. In already permanent from formulary, summary, to groups. submitted is we're in application code come demand backed

of has And see had across to-date indicators. continue positive proportion which learn Cedric still no It launch, the However, demand while to there that the treatments a important independent patient said these category disease more demand that certain as early practices, how as we initial coming a country. But real is and Samples is market majority have an of vials. earlier, us backed from in non-PE factors frequency exciting it's tells the component dosing representing impact may be reimbursement SYFOVRE. overall demand. meaningful approved about such to until will of and adoption to is

expect permanent a we some the in sales and until obtain should As result, both demand bumpiness J-Code. we

to and geographic Looking educate focused teams on forward, and on continuing physicians atrophy. patients the SYFOVRE both are

out especially and ask by have was on strong to their about CBS encouraged We segment a Morning, for patients to the physicians patient SYFOVRE. been for particularly coverage, media reach treatment. the The requests push

educate to GA to physician doctor GA direct-to-consumer continue eye will and to vision their aimed through is We encouraging patients our as engagement, through patients at changes. talk monitor which with about our as well campaign,

centers. turning field Now with our team our to key we in expanded strengthened EMPAVELI, the half of and partnerships second XXXX,

Our efforts are hold than were of XXX at taking first therapy more quarter. as patients on end there the the

received We have with the in approval effects PRINCE to-date Phase with as to of the sNDA data, discussions about the Phase-III enables more we are momentum of the us FDA gaining which PEGASUS even and XX robust XXXX III physicians week EMPAVELI. results

significantly the potential the approval will looking of on therapy. believe experience the which patient We are forward also improve EMPAVELI we Injector, to

me let over to the Now Caroline. call turn

Caroline Baumal

Thank tremendous journey at a It Apellis. start to you, my Adam, and been good afternoon, has everyone.

positive. I physicians of my peers on lives. my SYFOVRE, meetings approval Following potential of the embracing since in been I attended proud transformative patients' am to colleagues the several has fellow the launch retina from see have and SYFOVRE retina the feedback

strong were function. to sham. also light that and treated social eyes with a best months. Patients of compared showed the we equivalent Alan treated post-hoc lesion by one this meeting, measured Remember week, quality-of-life were Data patients analysis. as sham SYFOVRE-treated study had showcasing vision quality such corrected the reported RPE or separate line comparing In photoreceptor Ursula which a in visual And sensitive cell retinal more preservation presentation letters last in which XX both RPE, Dr. visual for a Just VFQ-XX, by a our function is outcomes X.X and or clinically at reduction questionnaire Ophthalmology, also for presentations visual vision. a and Results consistent Phase Association functional function the the Vision acuity, with we were given new demonstrated loss or driving, fellow GA leadership others. by compared with retina. untreated validated are with when BCVA, life in presence are to as maintain integrity of visual and photoreceptor X ARVO. extra-foveal of SYFOVRE cells, shared over cells for demonstrated and Schmidt-Erfurth, to than to Dr. Cheng, Apellis patients required Research as benefits. benefit III on At eye. who a on given a meaningful dependency epithelial, in photoreceptor responsible cells function, presentation which cells measures substantial pigment of the SYFOVRE

We also continuing and upcoming study meetings. medical extension data X-year to forward look progress Gale in to are study our from this sharing

GA, pegcetacoplan such may for SYFOVRE other intravitreal in patients, that offer approved Now where is exploring are we value as indications disease. Stargardt

who has on to advance and partner, stages on developing of disease impact to are our disease. In the plan in specifically, early evaluate of SYFOVRE continuing those of in space, patients verge in preventing the loss also indications. additional GA SYFOVRE are the rare and We impact EMPAVELI the these photoreceptor we Sobi,

autoimmune III transplantation financials, to hemolytic will Phase the for X hematopoietic complex the complication glomerulopathy, a anemia, call the and in both trial stem-cell enrolling diseases. Phase a turn agglutinin and for cold Tim. a review membranoproliferative a Tim associated in stem-cell severe CX type in patients for disease, microangiopathy, a of common And patients over immune enrolling trial hematopoietic of now are thrombotic for is rare X Sobi Phase and transplant. I We glomerulonephritis kidney following rare trial

Timothy Sullivan

was revenue product for from in EMPAVELI we We forward weeks first with future X on a revenue it product on the to you, these to in revenue the full of the XXXX. revenue of be the physician. the today is EMPAVELI, anticipated physician Thank inventory focus shipped revenue, will on million and channel. Sobi. A of consisted includes results, in which collaboration the shipped products $XX.X financial and Caroline. SYFOVRE is going release net X distributor, based few it at SYFOVRE recorded the on-hand Since for to comments like $XX.X the to both expect distributor Therefore, and highlights I press the remainder $XX.X when demand. the quarter when shipped approximately million, estimate levels inventory net in is SYFOVRE product million Total earlier just not issued revenue, to

do and to on heard And about the ranges. expect are coming not our one pharmaceutical gross-to-net. are represent days standard full more the of within runway. SYFOVRE learnings anticipate say guiding launch in We the as in be year's Other than we share will intend not we the We quarters. you've it already, that results month's early to

and of expenses R&D million, reported loss rest were the a G&A expenses the to Turning $XXX and of P&L, were we $XXX million. million net $XXX

which As equivalents, XXXX, completed follow-on million in of XX, includes $XXX Apellis February. cash the cash recent March and had in offering

We now further We development of balance ongoing turn XXXX, into our upcoming remarks. to fund Apellis' call our the we as expect quarter SYFOVRE in on over to current back milestones. I EMPAVELI our operations Cedric execute closing first will pipeline. confident of and including Cedric? our and remain for financial cash the future continue the to launches

Cedric Francois

we SYFOVRE now the important is With This exciting in our PNH blazing available an a our market are Tim. and new position and incredibly is in you, time Thank patients, trail expanding. company. for GA for

we a broad several programs global being as This achieve well portfolio heading late-stage leader robust disease we into programs our clinic. a of us vision strive clinical position the encompassing complement. rare multiple continue advance of to as strength as Additionally, in gives pipeline the to

Let's the operator. for now call open questions,

Operator

line first of Our question Madhu the Kumar [Operator from Sachs. Goldman Instructions] of will come

Madhu Kumar

kind it way? maybe about lumpiness you the what very kind of is to made we think growth some how think Tim? Like, of on this kind the the or or numbers have the terms at for should into afterwards so-far So kind future in comments around practical a you be will Do And way I'll of lumpiness lumpiness. of decline or think then, about Is look where to follow-up you do flattening quarter, and suggests kind think follow-up launch like a across about in some to of this is variance quarters. April a lumpiness? Adam of of the way the

Cedric Francois

Madhu, will Adam great comment this. on to let hear you, I

Adam Townsend

strong commercial XQ first indicator the for And with a X,XXX we're with went to and thanks question. demand we're Madhu, that the your me for see $XX.X so samples and Obviously, far. continuing thrilled more momentum that importantly quarter into That's the about the vials. real also million, sales demand. out X,XXX

progressing the GA unchartered and is say, and X So starting some only it's keep obviously, we've market relatively those trends everything will that of demand. category, the really months for about to new, learn in mind is well. I we're various been on may impact adoption

little a bit around to et cetera. dosing have We frequency, learn reimbursement, more

So we our little get October. that permanent in the leads a bumpiness, to until bit J-Code

might running bit that one Now, a to perspective. of little want comment Tim, a you forward on from way forecast

Timothy Sullivan

Sure, are month if way kind first so about you the we quarter think really the will. of X-week -- a numbers

potential per this take in you divide and or as XXXX X,XXX if that forecasting. don't of average weeks, roughly terms and that get vials sort an So it's rate X weekly at vials so over of growth week we

with of is you distributors in vials are that there X X we'd that, recognize keep as like because weeks you number. And obviously to the of the those do So -- our distributor, included we on-hand. like want to roughly revenue, portion what a basically, revenue can instead to

So on weekly a as of basis. vials go -- those grow that, sort retinal out you the to specialists that

is also bit. continued lumpiness April. to like a demand week Adam inventory have we have But how seen different but strong You think But said, again about some that's grow we seen that it. as and little in we've to each

Madhu Kumar

your overall? how as Okay, would about you path kind for is Tim, of or company Maybe this from a great. think to does as follow that basically of this a number refine Apellis with perspective about X month to shift breakeven so sales, is XQ you

Timothy Sullivan

this conservative first continue this, we like that view. number it's Yes, we again, runway, obviously to so guide different so scenarios, said, evaluate it's we'll sure, a we XXXX, we're our take to scenario Again, of case quarter a best so forecast and that's number going is I early cash of the a but to conservative see.

Madhu Kumar

to any could external have actually or one I of kind guys more a follow-up you on think there breakeven? path leverage Okay. that, move of is more on you kind further could maybe guess you the kind get little of that to have to clarity things

Timothy Sullivan

we infrastructure relative how that we've our we in in -- of of we built-out managed I how finance really and think been we've think the creative -- came. our expenses, Yes, terms especially we've our terms when finance managed company approval I the and when how kind of commercial to

that about So confident for but pretty when this, do don't guide we're think to I look how we profitability, we're I be pretty can careful that. we it on think we're thing the specifically gap going to will right but bridge shareholders

Operator

comes question of the Miller next line of Evercore. from Our Jon

Jonathan Miller

on quarter And number. congrats great first that

more from of for I that bit post analysis came lot functional actually to analysis dynamics commercial actually. provide you could the I'd on there. did? and impact But foveal a ARVO on the And presentation gave [ think et to run a I great market little the here, you of you dive a into love the cut-off you did would Where view ] analysis color love on the cut-offs functional sense get XXX-micron post-hoc time-to-event from? your if for like competitor come color from maybe cetera. those where how

Cedric Francois

it Jon, the over we talk well, is hand important, saw commercial briefly to Caroline to of by what about the to word really and giving that. and kind I'll then off talk the to why Adam of that start about impact

Caroline Baumal

link We've geographic the that is atrophy. Thank functional the there data always and slowing growth you, Cedric. believed a between of

lesions visual with in be this a noise confirm analysis that, functional show is a our there regards analysis at quality-of-life functional that post-talk are able with within do GA. were size have measurements get treated showed would sometimes In have our benefit demonstrated analysis, they really I that measurements clinician, patients did consistent as we that And we do the as before lesion. expect SYFOVRE of the acuity of in and was and foveal we zone avascular to what and why extra-foveal would pleased and able microperimetry functional the analysis the patients that to eyes post-talk didn't with their that type is was ARVO benefit. benefit year, in to this the last also to with microns, affected benefits, we that we're especially I well, And necessary that the think we to recent same analysis of foveal. XXX presented confirms that we that our show that data Iveric, they

Adam Townsend

against Jon, Adam, following-up. laser-focused it's label. executing just commercial is the Obviously, team on our

doctors focus the of our is our So around and there retina targeting U.S. X,XXX all

great is our the about within but and usage data, our sales on executing great focused of a label. our educating months talking think that's whilst and community, this team everything data I medical plan is So, there's from XX our

Jonathan Miller

follow-up Just in know there's lot I including as analysis attention be functional especially Will benefit? from a you filings? guys. -- been on the quick of that functional EU, the on a your ex-US

Cedric Francois

will. we Absolutely,

story, more is we materialize. despite to extension functional as course it piece the an we So as again size bigger and important to the and reduction come study see had this as follow functional to we're of but data will well of out very track excited of books, expected is lesion continue course

Operator

comes BofA. next Tazeen line question of Ahmad from Our the of

Tazeen Ahmad

other month? actually the a patients being drug are expectation versus grouping And follow-up? you good how detail month be the do start from it have every the as then on how are to many get X,XXX-plus vials I you that real-time those in initial of on put Congrats a shipped going wondering me So you well be do will to I'm of your used? about the And get just granularity? updates that on dose really launch. much is every vials,

Cedric Francois

Adam?

Adam Townsend

it's Tazeen, hey, Adam. Yes

phases this we launch by link the is the see is do seen. initial of revenue our in and So obviously, then the that retina practice, number vials you've ordered that what

based what either of the that detail from don't see I commercial are we but someone of from or the medical what team physician, used a granular the stock likely having you are those type month first to only or physicians tell samples I belief eyes patients so team the interaction my all of initially, the X call X,XXX in. is these quickly. of they're majority carry the on vials with expect them, can going weeks is we into is vast of the to and X What discussion of in level feedback is, So their fridge, our vials in that X,XXX relatively used affairs commercial how demand

and But patients monthly of likely was, to other your question part the or every dominant. type of is second what that month be

are type expected as of to using is So anecdotally are SYFOVRE initial for what within physicians is we the prior the the that to we phases hearing launch. patients

a treating consistent to say month, hearing tend you other month in why one also and moment. bilateral the is it's blind GA GA in are a that we the that at So this every other in disease, market vision loss progressing is and second is player every hear the who was a And our eye, are in patient and GA, dominant that eye with research. AMD physicians the in eye bit they eye, game-changer of and one second

So hopefully your question. that answers

Tazeen Ahmad

your if approved, get Okay. be of your managing just the them recent Yes market? helpful, launch, Adam. that in competitor this complement would it that's news next what's And the does Astellas being with then view

Cedric Francois

angle the partnership hand, needs from at of the focused U.S. all productive now, we for doesn't it are making for them and patient every very and in that wish and job very the to and good SYFOVRE happy we at Iveric we're on other first both future. anything, the in our for countries and Look, together. change Tazeen, available Astellas

an importantly is months-to as we dosing, the us which course, of So, gives important advantage we have competitive well. every-other-month that the we materializing in believe here come

Operator

of question the Anupam with This Rama from JPMorgan. comes line

Anupam Rama

assumed I to to many When how drug? sampling. here. that commercial on a give guess, like quick have launch is do of I a for-- SYFOVRE per timeframe patient sample, initial what terms the drug, you question in switching a on samples for the commercial transitioning and patient to physician Congrats

Cedric Francois

Anupam, great hearing you. Adam?

Adam Townsend

it's Anupam hey Yes, Adam.

So thanks question. for your

represent are really they proportion are overall meaningful samples of going of obviously So launch, important vials. and to a component our

samples experience new things, they it's only and Now, in experience request physicians who want to to and drug, with also few have reason request and the so. drug, has to their so tend do to obviously, understand as the file clinical why it can do a that they a class. A how to with patient's certification receive the drug administer medical this physician form samples, they to the gain

to the to our the want based on So use is an business towards we they they piece we important progress forward permanent and know of level they it expect tend samples need it, moving how J-code. as of

to majority Now, is samples to your I the vials anything do commercial think Caroline, end. in there the from perspective, add? want of lead you

Caroline Baumal

think to have use have with Well, and us my are input gap, flexible think treatment And to to important they're meets pleased their great I they're with how having interaction samples I option really of needs label available, gives for GA, so all experience for excited colleagues fill this physicians finally far. and that's have Apellis the they're-- really a been they my this the the also medication.

Operator

line the from with Colleen Kusy Baird. comes question This of

Colleen Hanley

the on quarter. Congrats

X,XXX the cover does of of kind different you're how the what's breadth and demand stage? this vials X,XXX called So of samples, many prescribers as the in seeing Adam prescribers early that them

Cedric Francois

it over Adam. Colleen, to handing

Adam Townsend

Colleen, it's Adam. Yes,

of in SYFOVRE. already continue teams, that and targeting for that. they physicians once, me X,XXX sales actually and is retina X,XXX least medical So physicians ordered territory are at the obviously The every has do thrill we a commercial to engaged commercial and actually we vial have

usage getting country. of So across whole the we're the

seeing the practices, but coming practices. private-equity-backed independent also majority from from is are usage We

-- centers, anecdotal. using, and have have from is the that to good is center with the conditions across wanting there the getting launches this so target of X,XXX initially we a early I apart now speak challenge going stages think we knowledge type to again already of so vials in to physician using So throughout the using we a a But only spread live mix that's don't of we're who us there, physicians wide physician who are of are country. see

Colleen Hanley

And remind expect strategy you're working How you just future? can many how as -- for and us to with then helpful. a we come more online distribution? could distributors in That's your distribution follow-up, many the

Adam Townsend

Colleen, it's Yes Adam.

So we not distribution strategy, that the public of have but physicians needs the the that all our all our we on of and coverage all plans distributors of X,XXX meet of have. they may

happy at very distribution public with but we're we're So our it. process on the not moment,

Operator

from question This line from Nochomovitz comes the Yigal of Citigroup.

Yigal Nochomovitz

the Congrats launch. on very strong

just basic getting something. vial you've missing X,XXX, really over the $XX.X the done a Can you clarify more me a I Just million you're so little vials that's or question, be is so to million clear, $XX so maybe must just per I'm please? getting WACC commercial, over just from $X,XXX how X,XXX and --

Timothy Sullivan

that. Yigal, Tim. take I'll Sure. it's

when doctor vials it are distributor, they we go distributor them then when the the them will to the -- revenue and the ship will to the when requests shipped doctor. the distributor So recognize -- to

X,XXX step, revenue step. but recognize the the we And second that so first is with

So as revenue. We stack we've vials stay already the at that level that tell some distributor there are you… recognized don't of

Adam Townsend

And, Yigal, it's Adam.

and weeks to inventory We reminder, of a as expect X X on-hand to to X our right? keep weeks. about X Just distributors physicians between

Yigal Nochomovitz

system, engaged of actually the there percent the as a X far have what the sense you us X,XXX to Okay, X requested so with sampling, another in weeks okay. distributor then to regarding is And not it's physicians give revenue, samples. can that so of you've but

Adam Townsend

being regions we've all our of across used there of vast so of across the seen Yes, seen those in we've physicians in samples that geographies. all our number X,XXX

Yigal Nochomovitz

in so-called re-calendaring, any make evidence with talked SYFOVRE yet? to that of of capacity. we've practice then And Have room the about past patients Okay. AMD seen you dynamic some wet the the for

Adam Townsend

your Yes patients physicians add to want well looking Wet their their heard calendars at both as managing you and from as the and GA patients, there. Caroline, we've anecdotally anything managing seen experience? that AMD

Caroline Baumal

brochures into fit are paradigm the really that are have fits think is and treatment for the patients, nicely -- already with this materials our enjoying we so physicians Doctors well Well, I want explain within And to really are educational this anti-VEGF, that that. before, patients. that recognize this treatment, the burden they down to they GA. really going patients vision they was their have, of save this able enthusiastic to and that reduce and about and

we retina will and how know that finding -- to treat colleagues have no ways I patients, to adapt be but So our to do these adapt surgeons, new to retinal my injection able as physicians doubt burden and that. to

Operator

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

Steven Seedhouse

ask, to any so interest takeover that reports, various strategic subject course, wanted of news discussing there you Apellis' have strategic Apellis, I been Cedric, in priorities? to comments and wanted make on

Cedric Francois

course, that in the well, of making commercialization in squarely stage U.S. patient there's Steve the of that Yes, needs always those of we interest. speculation every are But are we to focused on SYFOVRE available

Steven Seedhouse

asked update initial in, when current first just just what that? is from you and GALE if I -- sort data coming of on that that. can Roger and the the Can would get us follow-up entail,

Cedric Francois

on already of what XX-month going happens about to be end that the increasing at over-time we Conference are Very sharing effects we is mentioned the update So GALE full presenting ASRS July. excited a to data. at

the update on So XX-month is as be dosed. to to going these this subject they be continue

Operator

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

Philip Nadeau

Let on of launch add from us. Couple SYFOVRE. of the congratulations our questions initial us

that you approximately keep mentioned physicians you of X think inventory vials X,XXX X on-hand, week. I per expect so weeks Adam, to First, to

to that proportion the that be time seen during you first You March. were re-orders X,XXX versus of willing orders? Would some have reorders should share

Adam Townsend

the Phil, reorders. details but of question. reorders, Yes, thanks the those into seen we're for we've not going go to

Philip Nadeau

rate. happen around question, recent into that's going something to were effects? there settings then about And any endophthalmitis, seems it. context reports second side the future put like should endophthalmitis Got How a of investors database it at background

Cedric Francois

Phil, answer that I'll let Caroline question.

Caroline Baumal

say culture endophthalmitis intravitreal the had I'd procedure. far. been as injection with and and based that of There you the the injections blindness that clinical thus performed within was is that This trial. a and mentioned, positive number thus fears profile this we to SYFOVRE, with well of in misquoted it related deemed And has single rate overall, encouraged as was case far the the was are this intravitreal corrected. consistent being safety by line is reported on

Operator

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

Justin Kim

lateral this -- on seen maybe an single the eye for and that in might a ophthalmologist? being following-up be a these with that observed of just even by initial by Maybe specialist patients lag congrats -- the driven the fact the just seen a or in by kind eye nothing adopters not an and GA SYFOVRE, And is quarter. therapy reaching retinal patients in optometrist on

Cedric Francois

Thank much. you so

too Justin I to think on I can Adam, share this. you much hear don't great

Adam Townsend

Yes, to thanks, to you. Justin. Good talk

So, we our prior of prioritized sat call physicians. to initial patients that research from hearing the of The retina earlier described based tended treatment on the in wave feedback to did books and first yes, the be, they we're the physicians. on I period, launch, because

been So their impacting lot GA to your to might eye can physicians optometrist. tend assumption extra-foveal their in ophthalmologist of A and be have quite these set or not accurate. that might back be that vision have one

that that's the Henry we're a seen Now, go lot and to believe patients those GA is the strategy. loss that aging, of doing want of we moving their doctor. what the marketing and we people natural to important with just basically Won't forward, their is elderly, see we do campaign particularly work we really think you have to part and with eye wanted vision believe, part drive that some Wait of a are We Winkler, launching where direct-to-consumer might

move to really his GA is Wait of Winkler to that of us, decided vision looking their our really be to So see for a important us Henry thrilled And we're his went going and with emotional educate as go loss. has tool really story partner physicians. to Won't patients father-in-law his father-in-law patients because campaign after through

doctor. So help of question the -- will your that and retina sitting that piece patients about addresses us the with naturally

Justin Kim

Okay, And updates to-date? maybe profile great. there, safety any on a meningococcal on for maybe EMPAVELI, given just the And thinking of just sort any profile? follow-up infection about update

Cedric Francois

And wants we case have that, we've not we're north and you, know years mean, don't happy of to what No, yes. Adam patient see add much so he single do EMPAVELI pneumococcal crossed We extremely seen. X,XXX infections something thank so have we dosing. into if unfortunately to of so of with I I a

Adam Townsend

Now great. them Thank question. you, it's asking EMPAVELI Justin, for

and of EMPAVELI massive we're fan great I making and a all it’s progress think there. PNH things think I massive,

over EMPAVELI it Cedric shows said we efficacy are strong driver cases know be as safety compliance of within still that high So PNH a And continues me and to the XX% years. market. X,XXX the still see patient really-really a we

quarter-on-quarter. growth and I'm that what thrilled is great make with to So team doing continue

Operator

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

Derek Archila

Congrats on the well done. quarter

the and let a practices. the physicians, couple me of logistics how questions in working wondering, from journey you of so, Just first-off. on any of kind got patient just feedback from us kind are I was if the

program? practices? areas the run their impacted future I SYFOVRE plan you and this to sampling do And And has earlier, maybe how So finding launch. second missed to question are in actually the how then optimize you for the long

Cedric Francois

will Caroline. I And sampling. talk But Adam much. to then that so hand about you on the will physician Thank feedback

Caroline Baumal

colleagues a team who Well, know to retina positive. impressed contacted many medical doesn't the and feedback company, the the colleagues. I has who know the relatively and information. amazing my physician my so Apellis new space has as Apellis It's don't that members of anyone them and of really for contacted been sales

all really with and light into help the to with pleased are think patient that's I story patients bring interaction SYFOVRE. initial their So

Adam Townsend

nicely it's Yes, I Hey think it there, you Adam. Caroline. said Derek,

the during for pretty in important we be J-Code phase, believe sampling case get And you previously, chair it, didn't patient particularly I said when yes, launch to as still just about they October. that sure in permanent they go a how goes to So, everything Make of we they want drug. going this some try et to the in physicians understand want that gain experience before it's miss cetera. us

samples demand. going be us. it's I as do of to important a an for tool sign So see

Derek Archila

the that. with Yes of is my and there SYFOVRE. chair you the communication, maybe like education just the as to or we've of kind to again, patients wet-AMD I the just any issues heard feedback question, on time these one in first pushback follow-up some I for so kind know, around compared guess

what So hearing kind as well? just curious you're of

Caroline Baumal

educate patients were we a to from changed an see eye save was injection, having have they explain to to wet-AMD paradigm. think we something were treatment patients to wet-AMD had an and really this mean the we disease had back to I I Well, care opportunity have can we treatment all sort able patients where completely change we blinding earlier the of we to for when involved initially vision. to is same providers so thing. We

can these care to have GA able paradigm but community. earlier, all anything patients GA, providers involved, a course, the education start Thera and SYFOVRE haven't for it we So patients treat anything, kind docs, but takes we're for treatment optometrist, these docs, back, little not eye treatment first now patients for I really just of we of the the so start ] to bit new obstetrician treat [ get roll and of and retina and heard that

Adam Townsend

right. Adam. Derek, just it's I'll on Hey too, jump-in that

disease last day education obviously, from of we doing year. So were the end

doing our really with all physicians patients to we've to, the atrophy, physicians a we've been using patients from speaking These within conversation centers and physician a patient, SYFOVRE chair feedback and teams educate the are describing that So incredibly around job well. physicians have comfortable they geographic is of really done the field very solid been anecdotal disease. compliant goes job and that are solid also educated,

far, very, So well. going been conversations have those very

Operator

line the UBS. with from Merle Eliana comes question of This

Eliana Merle

guess front where the opportunity on where a just perspective are from but ex-U.S. commercial provide spend force you differences can couple preparations, just of that I Maybe you second, on on think progress. commercialization your regulatory preparations on the the Can the how And build-out latest that also a confidence that about any we and out? the any then gotten build the the all of your in just terms ex-U.S. should, that just in on how any built-out. can and strategy European commercial of Europe terms review review congrats on European there you've commercial key and you is and like And versus of comment approval. ex-U.S. then in color on sales strategy terms you first going the are there? And feedback you just terms in Europe. in and U.S.

Cedric Francois

you. frontier world Thank Switzerland, you our expected well. the I so much well. between rest look, as as mean have Canada I going and European going consortium Eli as very as next process Australia and well. filing Well, Europe we the is regulatory we of hearing the U.K. was the great had mean. is accepted by

important And early I point an many many, it's we that We there expect force established year. to ago. approval think commercialization out next in Europe our years

about to Adam regulators, in many also in, we to diseases but Adam supporters, was believe, as level the regulators, a as has EMEA how soon how with kind This layers, needs we now. force talk just whole quite this is with doctors, involves longer Zug, understand Switzerland. our of market, with for will course, many-many in what more about to had bring years not I retina, the been have you people work as a established, those he because So know. The also we of the the are us, to political which And came established so and bit Europe, but going awareness gone that. than little be X of that and with and of frankly, there important payers landscape

Adam Townsend

Eli, it's Adam.

those is $X.X is you So, a there if in can million obviously million are X yes, for $X and million opportunity to assumption us, GA massive ex-US. your of the see U.S. patients worldwide

Cedric Zug beautifully where test, We've based is our driven from. And out and corporate, first building we importantly, So outside in affairs commercial and the Australia. said right. from the strategy our is U.K., launch we infrastructure, leadership to started U.S., the the its that's our medical in perspective European Switzerland, annual in been in ground of and the office footprints Nordics potential also on feet have a Germany, in-country Canada medical more France, Italy, put

So we're getting ready for this launch.

do going and we also to go teams. We've really to and we'll lucky We're talented in be to European and Apellis the regulatory attracting thoughtful process. onboard we a super very are it through right. going our We been milestones when wait join for as people very people way,

a we as go ready we as the towards to we're work potential towards and of approval the So, year. end

Operator

line the Samimy from comes Stifel. question Annabel of This with

Annabel Samimy

quarter, great congratulations. And

the I so got patients that that the drug or I to patients there's going risk are patients? shift, earlier you exploring does want benefit go benefit is, in Do functional was first going you've that that demonstrated you're you that the first square physician mean, follow-up be in are think then extra-foveal, So the that your of go a maybe seeing be since there? And had ARVO. help could that to who is you of developing in moved earlier, data, anatomical based ARVO? And which at I you're have it's understand functional mentioned noticed at that to away interesting at in technically reception the strategy change guess to guess the bit? to GA, Clearly, different intermediate was targeting from us away if are you thought on any information center, question is, current you lesions the that how addition I I you function with ARVO? from evidence presented presented data just from that this the disease, back what of that population So given the the further -- a at seen from the little the the I was strategy so

Cedric Francois

to comment reception, your function you, more acuity measurement for ability I important read the that is Caroline much, much than central is think Thank only but obviously vision, of through XX/XX the to Snellen just ability Annabel. would on a it's visual operate imagine chart. Snellen be I right. the severely vision people walking impaired. function your remember through on your looking you chart, will New have get but example, York, to always and Visual And straw, a

of visual within fovea. mind, in context the that with photoreceptors presence So is determined the acuity by

central we the acuity patients, down. these patients theoretically ability look that and have over and impaired visual slow extra-foveal that question, central time then the that when that at baseline does means So to can get we study vision at in still the at have look you

we how that limitations acuity. of important a that measure just of But it very again focused function study. So the visual element in within sense, on was

that You recall may that something presented more September, a in last that data periphery. microperimetry on looks we year as is

up the the which effects excellent as an and it risk SYFOVRE features versus is point, increasing over to of bring the you most one beginning are of So relates that GA, question -- the then time. intermediate of of

ability of year into the from disease of north slowdown in So well increases X. you to go the the the year progression so when or to XX% first approximately XX%

slowdown the randomly have of the did in just I the just as intermediate eye, the What early for from we So regulators able gets as important. Intermediate patients have occlusion appears that GA possible is to an that. have in patients that neither, endpoint. precisely way who used the is that kind direct feedback early of cannot FDA the atrophy. or drug progression is may of and AMD, in this the an geographic and better onset is treat at this you AMD the to all ability overemphasize treat, longer is not very the term it hence to and indication

geographic to atrophy. as So in presence possible that before as the have what you actually context, do is want early go treat we of

OCT and that's can where go can with what we SYFOVRE do now to next to that do. want we study imaging So

if Caroline want you maybe comment the on briefly on So feedback the -- to you that endpoint? got functional

Caroline Baumal

would clinician. feedback the because with say, it Cedric. as consistent positive would was expect Thank we really I you, is what very and, a

we patient acuity through of example have really they any have variable. disease, fovea. the like, see be noise a can patients and visual For lot and to GA Or measurements severe when the have the

results as we would gets visual demonstrate and lesion to able stable this. and reproducible why that's from so, the fovea to more And further expect have the we're

a really trial study in a at looking big enrolled this. patients, notable, we patients group of in GA, had the second-largest The we heterogeneous and GA other that's thing really

really reception excited about that's was with this are extra-foveal why to more data. So clinicians really we're patients. and this able easily positive, demonstrate our The

Annabel Samimy

really those that mentioned? maximum guess, So are that that just able those want you point, Okay. and for just might lesions had away X target would from that I that do mean in on follow-up the maybe, categories benefit different have further be the population that patients? center you get the to to

Cedric Francois

loss. only focuses many you're in Annabel, at acuity, have patients of cell would foveal photoreceptor who visual so-called foveal to for benefit patients, involvement subfoveal the but start patients better than going extra-foveal to Again, also patients we fact down that benefit will the know then if the the you from study, in see a on patients slowing

So in that established something in studied adults. clearly patients we and is that our X,XXX we studied early that

Operator

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

Joseph Stringer

on progress in few both A relatively gross-to-net, walk sort launch? of And a us quick constant remain if you to ones guiding from XQ you you us immediate through for this tremendous guide as impact expect -- it. maybe permanent But the you're range, I do not the this start on the guess for you just normal sales of the J-code but year. can curious you becomes through then available at

Adam Townsend

Joey, Hey, it was but about J-code. a hearing I time your question, permanent I think first hard had

things guarantees few that obviously timely that J-code and about a a of So, confidence manner. getting permanent gives a reimbursed is physicians in

October. than have there payer know, one to think that in you think been claim-by-claim, working impact of I At for a do will since the have to probably and we're us I claims, of thing launch for moment, understanding good obviously stage as our get launch, to guys that that that the and reimbursement us So that XX we for well, nice it's as and as working know, today claims. more is

So claim-by-claim. in to but real pretty we're make doing well permanent working has solid there we sure we're J-code October, get through us obviously that as impact the a for

period, patients GA these that J-code is the the side the majority related the smooth Now the manually system. challenges this come will to And we during so first of of be that that we've and can payers process post is is it spin will time permanent some also we basically tend seeing these J-codes. as through improve this anticipate done to overtime, seen the temporary

hoping didn't question. your So considering, it. I hear I answered I'm

Timothy Sullivan

answer first I Did your answer the he question. gross-to-net Yes, can part?

Joseph Stringer

Yes, very helpful.

Timothy Sullivan

Okay.

that's very it but that the government also SYFOVRE, wide. to fees, In guiding past, So add to can which other we year-to-date say pharmaceutical realize our discounts on margins, a will and charge-backs, little and in pharmaceutical on bit we it We're haven't is is willing and typical you give blend and XX-Q, in the within and which gross-to-net, it's XX% the and we EMPAVELI I range XX% on do gross-to-net, and additional we a returns won't does detail change over-time. that basis. on gross-to-net, disclosure rebates, be

we're what on So individual a but blended you break to can get by like, going a looks not basis it product. up sense that

Operator

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

Douglas Tsao

that seeing more PE congrats will on Could demand individual off provide play practices all ultimately in a both how those what means Adam, a color do different maybe of you've smaller sort spoken about versus it the -- of of little from ones. And bit and you backed out think progress. play the practice across you terms sets?

Adam Townsend

that indicator Douglas so usage seeing retina yes, of so we're the actually I see as really a board strong leading across for practices. us

coming sales. I'm thrilled U.S. as are had So and different before, order that And majority how from potentially they one guy, those commercial a all for sales each me who process, have commercial across said of metric a as is I've our on private-equity use the has and but our independent practices the retina backed SYFOVRE, territories

on working sign through-- initial and not demand are this centers retina also that appropriately to get retina just centers usage. of So to independent the We're with for the me, we getting drug. backed is PE a those patients work

only can and et-cetera. we I that drive to within prescription continue see repeat as target we broader So get progressing list,

board. it's a think sign strong really I So the across

So it's metric for us. great a

Douglas Tsao

to an individual or And terms in I Okay, just just samples their patient, samples can, offices? in for great. if request samples need to able keep of doctors around quick are to follow-up, a doctors

Adam Townsend

question. great Yes,

doctors but patients. don't individual them need need for yes, to to request they So request samples,

So they they use can fit. appropriately request to samples as that see and then

Operator

like the Cedric turn Francois to for back call I to would now closing remarks.

Cedric Francois

thank in you for And much. us all closing, so you Thank joining today.

and a to to later to to sharing you. Thank the for more the come. to year out We questions, are any in months today Meredith. us we This forward you if tomorrow, was and around look reach have start additional great feel free

Operator

conference. participation This program your you today's and disconnect. you Thank in does for may the now conclude

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