Apellis Pharmaceuticals (APLS) 27 Feb 242023 Q4 Earnings call transcript

Company Profile

Participants

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

Call transcript

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Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Apellis Pharmaceuticals Fourth Quarter 2023 Earnings Conference Call. [Operator Instructions]

Please be advised today's conference is being recorded.

I would now hand the conference over to your speaker host, Meredith Kaya, Senior Vice President Relations and Strategic Finance. ahead. go Please

Meredith Kaya

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

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

Now I'll turn the call Cedric. over to

Cedric Francois

and morning. you us thank joining for Meredith, this all Thank you,

reflect our XXXX. achievements our year, extremely I As this in past of am team, all I proud on and of

very The also remain to data for of Our with of high positive SYFOVRE our X years meaningful uptick We continuous for making commercial compliance a approved including readouts, data safety differences therapies. multiple position, X efficacy are and products, rates from and EMPAVELI ended year by and EMPAVELI the strong [indiscernible] and had both patients. SYFOVRE in up encouraged we

mission XXXX our for for resilience challenges, patients continued the While certainly and to our well on its now our position execution as us had accomplishments and deliver in future. XXXX in

anniversary, role and what this now launch launch year celebrated mid-February, on that some than our for central SYFOVRE summer. we clinical challenges in These physician and injections numbers, Retina benefits at has we SYFOVRE approval of place me unexpected community's Let administered based developing We details practices in our underscore on these it approximately XXX,XXX confidence been. since remains a the ] been in with including last and past the through with trials. the recently XXXX. And estimated even rare numbers priorities expectations share to XXX,XXX SYFOVRE's $X.XX our SYFOVRE injection. Phase X-year lives. have doses distributed exceeded an More February, estimate been and year patients The of of had importantly, have Beginning faced SYFOVRE. risk vasculitis the to rate improving patients' retinal through III [ per approximately

In in quarter, We the revenue. for in U.S. achieved SYFOVRE product fourth $XXX revenues $XXX million we full the reported million SYFOVRE for net year. the

are the more it SYFOVRE XXXX, While we we meaningful growth, patients have and to medical and with seasonality to to forward GA far, SYFOVRE relationships and the to continues already need to access activities, these with worldwide. U.S. in [indiscernible] more to retina the year. in established in throughout bringing community. on first are experienced maximize Key show we've including so modest priorities In to the and quarter look our our building in patients the commercial

expansion global the our me goal duty with comment Given SYFOVRE, European on ]. [ let

for CHMP, a As negative marketing application EU. for in SYFOVRE Use, by we of Committee the Human Products received of Medicinal you know, or the the opinion

our of has in the from for more million in and steadfast Europe. patients efforts, GA treatment communities physician remain than we disappointing, in patient need received extraordinary. SYFOVRE given and is feedback this While have we The Europe the support across X.X been

for several for would retina new European We highlighting SYFOVRE EMEA be from treatments have organizations, of multiple important to and been patients. sent how informed letters need the

addressed. are application key questions we such, initiating includes ensure our our which of As to are a [indiscernible] revising that reexamination

experts to uphill be easy. be in decision is work strongly quarter. we we've and Commission with times many continue opinion throughout including to as clear, in the a final know reexamination the and an is by we and European closely If believe To that we this CHMP with this third at to a and our SYFOVRE in It be second anticipated upcoming the not before, connection will quarter. issued expect many a meeting CHMP said community the the We in positive, the not going benefit treatment, battle, likelihood data, demonstrate will success retina analyses this of an But stage. agreed the do [indiscernible] at with process. be

PNH was and We for million pleased EMPAVELI with innovative first-of-its-kind fourth launched to kidney feedback the injector, and diseases. net [indiscernible] in million volume an maximizing CXG adoption we approved Phase The been our and rare Turning forward and in Mexico EMPAVELI. U.S. far. to data fall. so And market look $XX X debilitating last We've on for full in high-tech $XX III and in year. generated quarter the the will product injector, position and and very focused also and IC-MPGN, remain XXXX, revenue readout

fully from Our data study line Phase study III and this VALIANT is expect top enrolled we midyear.

new Over couple have launches, but the we commercial and years, advancing. focused programs earlier-stage other been past our of exciting products on we've very

shift XXXX, pipeline me Let which R&D the term. to an to progress early fourth our our for is long to eye priority with

the in to which APL-XXXX, our data CXG with IC-MPGN, In dose and [ expected program, we ] is in now escalation initiatives siRNA study addition on later this a Phase BD are focused year. I

on testing expect with year. gene also the share advancing are [ this we to ] program which we more Additionally, beam

an patients unwavering entering for XXXX needs with strength, create address to commitment value of and unmet to are shareholders. a our for We even from position greater

commercial it medical to to And and discuss now turn over with I activity. Adam that, affairs will our

Adam Townsend

million demand XX,XXX with X,XXX underscores in net growth was quarter, vials fourth of August doses a the Apellis PNH. in U.S. Thank This physician revenue. weekly the year launch of with in Starting commercial for strong and It of including product samples, practices, commercially delivered ] the XXXX. rebound in XX,XXX began generating we the in you, approximately to SYFOVRE In [ $XXX commercialization that Cedric. and SYFOVRE. big EMPAVELI GA

Our engagement our with patients execution was driven by physicians, and stakeholders: meaningful key payers.

appreciate of in much new both number coming to how doctors SYFOVRE majority motivated to and coverage. week every from are orders robust with physicians and treatment. seek every their weeks, existing flexible Patients weekly have patients since payer continue X reinforcing launch. with order regimen. to patients see a physician we new to vast dosing a are And the more And double-digit sites treating practices continue SYFOVRE We X of

We our are encouraged we in launch. the demand February growth so by months are quarter been and seeing of January since far. first X the have biggest

seasonality as visits GA January chosen Today, of the some shipments. market current been as did the XX%. what million that as These wet with recertifications with a #X expected, result seen we Medicare seasonality doctor ] we with of some and of However, has in are delays well a weather affecting U.S. consistent trends see SYFOVRE as in estimated is the there GA market. treatment anti-VEGF products in patients the [ share approximately X launch, AMD were with At product

may are GA than suggesting this learning patients. are to X.X even be population be available for expected Now we we with estimates million that patients, treatments the bigger there may up

we to position. our build forward, to maintain and this continue market-leading market Going expect

protocanalyses. experience to GA will XXX,XXX more real-world the in patients. over and on highlighting time injections clinical with visual approximately trials We our saved multiple which GALE experience study, for vision been more extensive be increasing reductions been preserve between laser-focused extension XX% SYFOVRE, in and treatment executing our with include growth function estimated SYFOVRE demonstrated lesion in with administered of longer to shown key meaning our than have strategy, effects advantages has

full EMPAVELI Now Notably, net The approximately rates the to continued remain $XX In in from demand a product for $XX indicators in trends witnessed approximately the And treatment-naive XXXX. have year. across generated EMPAVELI. million of patient XX%. leading quarter, fourth through XX% positive incredibly end at in population patients. key million U.S. this of the sales, the resulting total XXXX for high was of compliance

We strong to continue have also safety very a profile.

rates and meningococcal X X,XXX of over systemic infection very enclosure had of [indiscernible]. pegcetacoplan years have low and We have patient of cases

facing patients. with be are competitive the twice-a-day will and convenience a of We PNH, in some of a oral recent to pill an appealing approval more expect the product I market

mobility, administration and since believe the offering greater and injector. injector I the previously the of EMPAVELI approval patient feedback position. commented competitive our By positive on we fortifies simplifying experience elevates

that Caroline, physicians did and both outstanding medical by working of it hand an night over medicines need. proud saying incredibly am I SYFOVRE commercial and to and patients They XXXX, EMPAVELI throughout Before teams. X to and job I the these I'll day close in bring to

With that, the me call turn let over Caroline. to

Meredith Kaya

data the a of and at Ophthalmology Thanks, SYFOVRE both November, Academy continue over every-other-month feature an X community Adam, had with time data active [ American which show EMPAVELI. dosing, we and our effects morning, treatment profile. to These GALE-extension In SYFOVRE's from efficacy Meeting. We Annual year seminal of with good ] monthly both increasing medical everyone. of presented SYFOVRE years the follows within and for study, SYFOVRE continuous

comparison, the at data a SYFOVRE. demonstrating Society adjusted the GA retina reduced and where our we treatment SYFOVRE XX-month in post-hoc year presentations, more terms in GA analysis, GA year or date. of in the highlighted, so than medical already largest growth were a with with presence XX% we data, just significant analysis following in is GALE has compared far indirect X data lesion a Macula in to non-SYFOVRE shown by lesions Adam recently, This Most matching our preservation to sham. effect busy As XX-month been including function had oral MAIC microperimetry using XXXX projected treatment X patients of meetings. with

with disease patients Turning control data for We, that long with the hoc presented and These efficacy of burden common the rapid their at partner, [ to PNH years, and transfusion-free ], that in X up and achieve data Annual sustained significant Furthermore, long-term along patients with December. showed on for safety a PNH. to can of is help majority many it alleviating disease treatment over EMPAVELI EMPAVELI. impressive our living term. EMPAVELI patients remain Meeting Sobi post ASH

of of are Phase had line treatment is weekly Between Kidney top over placebo aged receiving disease the study, XX for native kidney available. and X,XXX disease pegcetacoplan XX It approximately data VALIANT recurrent XX% in patients were to end-stage include new placebo, and a or potential IC-MPGN. with the after treatments primary have to at II VALIANT data split receive U.S. indications, only pegcetacoplan years. or XX XX-XX investigating forward of we progressing CXG post-transplant X to we both chance from year, from patients transplant. patients up looking with study opportunity are IC-MPGN. to twice randomized CXG which who the to and X are renal kidney NOBLE the participants III Phase patients, there enrolled weeks. Additionally, IC-MPGN our for to these in no a kidney and Week, to treatment study, which in of our have Europe diseases or and present transplantation X,XXX course the CXG we recurrence the Study up XXX patients expect approved and mid-year. This between

will XX-week ratio, or as study a all XX. pegcetacoplan. at endpoint which from randomized patients urine to open-label of to XX-week the reduction to in creatinine this Following phase The period, proceed protein in the patients primary placebo baseline week controlled receive UPCR, compared is

shift evaluating comment I'd the gears patients disease, safety efficacy CASCADE and like CAD. with study and III the Phase in or to on cold pegcetacoplan agglutinin of

CAD disclosed, express due Sobi As our This due due to of study made being and number efficacy evaluated been for not gratitude the the to and in concerns, for study decreased and the to decision I'd has need in mapped. previously space safety medical the study. to their to was support collaboration. patients not like a community the eligible is the limited any CAD the

study Sobi the the is as working enrolled to for in those welfare steps investigators study manage the their priority. with next with

the turn call financials. will a of over Tim review I Now the to for Tim?

Timothy Sullivan

that revenues additional other product collaboration. Caroline. million brief in in EMPAVELI additional SYFOVRE million our U.S. in this of U.S. I $XXX the in details with XXXX revenues $XXX fourth associated million earlier net quarter revenue $XX product morning. additional licensing in revenue and can Quarterly $XXX and will release revenue million the we and million and net consisted million overview Sobi Sobi $X press $XX you in collaboration. Full you, EMPAVELI for a of consists provide associated year million year respectively. was the financials, and other licensing Total revenue to of $XXX full and in with and revenue and issued Thank find SYFOVRE million, $XX

the to the P&L. Turning rest of

sales point G&A million of I'd expenses a our and and cost out like loss we of financial year, full help and were $XX R&D in quarter fourth and the million million our to that $XXX For a $XX.X evaluating respectively, million, respectively. reported million business. statements $XX respectively. expenses $XXX few net items in will $XXX and $XX and million, was were million, $XXX million, respectively.

First, million increased line the primarily associated the The $XXX we receivable reported is in with terms we increasing along is typical that sales has which provide to item terms. accounts with at payment SYFOVRE receivable of year-end, line distributors. and payment accounts with SYFOVRE

we Second, represents the $XX instead shared certain were This R&D of No as now medical XXXX. quarter we necessary fourth the reclassifications $XX the categorizing in periods. in of from and approximately million prior G&A other costs G&A previously, to an million of majority are for an R&D. shift in affairs second half and

to expect certain our due shift and in expenses to of this our do trends when reviewing severance ongoing yet that from operating the we However, operating important not projects. reflect last down it restructuring is finally, note August And our winding expenses. efficiencies

said XXXX. And is what beginning I total XXXX. these I'm expect going that quarter, our be detailed less I XXXX we get to As expect not expenses than into in total we in efficiencies in to will expenses our while to last realize numbers, say operating

sheet. to Turning balance our

And had call ways agreements that in in in of XXXX, we continuously announced notes we ] equivalents. position. $XXX $XXX unwind which to further today, cash with mind, we December associated XX, of our and treasury. we in cash hold As to XX% the strengthen capped in into entered evaluate that approximately with the that [ million convertible million We financial

be in on to net XXXX. a to cash and up transaction $XXX we be if million net million and We XX, unwind capped including transactions million, $XXX The call. X-day approximately up proceeds will $XX this period aggregate averaging cash settled including, following February remaining additional total the proceeds to beginning based expect underlying on,

principal EMPAVELI costs, cash now convertible balance As and aggregate issuance equivalents, net an the of expenses with opportunities the that was remaining notes, cash million. operating all SYFOVRE of the combined from optimize XXXX, sheet appropriate expenditures projected said, our and our unwind sufficient $XX we be future. the call capped to of continue our and will will and December fund at foreseeable XX, cash evaluate unamortized times. We believe the to of maintain balance capital and cash sales That further to for from generated balance

any incredibly make. we available And we and to thoughtful as have levers multiple are We that us. always, will be in opportunistic decision

over will Cedric to closing hand for now Cedric? I call back remarks. the

Cedric Francois

Thanks, the Tim. was a This strong finish to year.

the on and seen our building continues be are of We evidence our success and seeing. learnings the numbers feedback are and ongoing in to we strength

the We are that's of the siRNA disease key all [indiscernible]. early patients focus in we huge determined continuing [ to renewed PNH including CXG to and our our in [ and indication elevating work. this, headed pipeline, our and collaboration to expand and With in into of execute program ] IC-MPGN. the are putting in progressing EMPAVELI a year expanding energy standard U.S. working maximizing in areas access first ] X while goal our we which by care in patient on new with therapy finally, the in and And with bringing SYFOVRE to priorities: also this

always, As continuing are global [indiscernible] become in efforts to companies medicine. looking forward as available sharing the our we towards leader they becoming and

call Let for us Operator? the open questions. now

Operator

Instructions] [Operator

Evercore. with Miller question comes Jon Our from first

Jonathan Miller

for the first be Medicare to growing making wasn't that the And Do have why accounting is the you to get on expect reexamination? EU relative orders that now I would and lot helpful you EU. will patient love up that even Congrats you enthusiasm in in enthusiasm wasn't be in secondly, on changed on the to truth you're will EU QX still again What's one, sense the the January that that reacceleration much launch. of and commercial examination? groups from robustly to Cedric, delays round? for how a would a in a the getting first March mentioned great impact from of from reexamination. for QX? the -- recertification a great QX fair on it that then February? I And will maybe start seasonality, if doc docs expect love

Cedric Francois

Thank you so much, Jon.

as So European first it to the Union. all, relates of

So and independently us. sent are to letters not that organization are -- these to them then that to we They are letters via from these sent review are us receive route.

So support. these are letters of important

to think to and their is patients support an I impact? need. to the That they for available this have make physicians impossible highlight Europe. it medical unmet it tell really the Will product They highlight in for that their us. desire have

It will mentioned, course, over is be to appeals battle. hand the will Adam. patients of rare as Then the But commercial is to always we've physicians having this I successful. support question, and these to uphill from it the an be important. As relates for it the

Adam Townsend

Yes. Jon, it's Adam.

seasonality February. of So start yes, we see impact the did January and

was So of that majority recertifications. had delays. to weather -- we And few the a also vast due that

always and We seasonality with the our the right? over of products consistent, we and anti-VEGF did some saw in interestingly, some homework with is years. So the it homework

], I XX in to mean, QX believe QX. in years versus decline approximately we that et with quarter-on-quarter demands. [ resulting and in last above to Tends be several recertification X% a example, is seeing QX EYLEA seasonality For cetera, due ] growth years, over the other [ not weather

February, that we're the have question launch continue your We since us. in do to see of all of March. expect in the through and friendly was, We X you months think weather stays January seen Hopefully, our and to biggest recertifications.

we numbers So as forward. in move see solid expect we to March to continue

Jonathan Miller

queue [indiscernible]. the Makes sense. get And or maybe I'll Tim, one in back for

Cedric Francois

Jon. ahead, it Why Go ask don't quickly. you

easier. that's think I

Jonathan Miller

foreseeable plausible saying it JPMorgan, you runway funded future, foreseeable the about and want a how profitability whether ask, but since that I future. I ways yourself be was might to JPMorgan you going bit you're could or and to sense that remember that. would changed I now not really that's you with was if more flexibility to the get done reach bolster want calls. at just the to do just looking a cash you've positioning that through Tim, through for these think little for you actively capped give were

Timothy Sullivan

thanks, Well, -- Jon. so

we -- That [ the capital And to through where certain raise mean be cash over project look, have the our a million the years. reported of which in us news with that get the technically in that put in a million essentially things great at with position. could in good like year-end. -- necessarily. as mentioned, position ideal out we $XXX without I could $XXX ] X But having financial call addition liability, capital it nondilutive in our we capped to million should scenarios So is also don't SFJ million $XXX puts to that, next to us the that's $XXX us done. we That balance. door an cash have really we

good the sufficient a and make strong a be have of sure lot number opportunistically in we position, balance have news available So could of a cash pretty we us to could to SFJ. be things. refinancing options is a That we're that

as that have we'll So we be covers pretty thoughtful it. been. And and again, much yes, opportunistic always

Operator

question BofA Ahmad next Securities. from Our comes with Tazeen

Tazeen Ahmad

it secondly, for And did question want what down. do I the clarification, indications Adam, see have flat to to a of And has ] EYLEA promised show to make point XQ historics be [XSYFOVRE]. a expecting expecting [ you then XQ on to siRNA to and I growth you just program? What potential you mention you on going in? are in are Just clarify, think sure this to XXXX. relative wanted not it's

Adam Townsend

Adam. it's Tazeen,

expect growth mean, in continue forward. we I we growth March see to to yes, to see in and February, continue So moving

X February and January since our launch. said, I of biggest As months were

also You've about samples. asked

it of to we see we're I So U.S. forward. continue what in something But as the we we increase I thought as didn't launch. continue first physicians, to the sampling expect would there continue our probably be will to the early to in through going do this be provide Interestingly, that, were would especially and ] I'll which phases [ honest, samples we move call we to quarter, recertifications. still

answers first Cedric. over So your hopefully, that And to question. I'll hand

Cedric Francois

you, Thank Adam.

now, this the and healthy that about out so is escalation coming the of out in Tazeen, subjects. more as years things well. on very first the are in about, of So things talk the several excited -- phase preclinical XXXX, of we're in to our we'll that come is It realm

volunteer to that how phase to and But in So The be what development confidential. course, is a are we're much is, will CX we pursue can how these we see what for for of believe we hoping that subjects. are now exciting we, there durable the very store healthy indications of that down course, knock going in plan say keeping we product. in

Operator

Anupam Our with next question comes from Rama JPMorgan.

Anupam Rama

in to about ask a what talked previously closer versus, I about being your What I patients? GA wanted think, is quick question. U.S. driving the is Adam, commentary the size you've million about you X population X.X million to

Adam Townsend

Thanks, Anupam. Yes.

as well So then I'll I'll to hand Caroline she answer has comments. any if and

that. have. So one find thing is launch optometrists we having physicians is because we with as our categorized think was about based you'll interactions an was to launch, you're GA lot but with our treatments prelaunch one also sizing that when first-to-market weren't many in work no what data, of found or And patients they terms patients to a opportunity there something physicians follow-up GA having were is like that prevalence they with lost that -- on was discussions their prior how with of found thing sitting

GA, move we tested optometrists. or So to drive they're and a diagnosed physician physicians. injecting amount of the go a effort patients into and clinic retina large then at to vision get an spent check And if their with their of

were interactions, now practices. to that patients moving the with into in been So those GA to starting are that lost diagnosed have we're potentially those follow-up find

first a -- to is So you than anticipated. that's from the perspective? add how interactions Carline, anything believe, doctor is want we based the bigger number had do market we on that those

Caroline Baumal

you. Thank Sure.

other is to care that think there really only it. physicians drive the eye has to patients. getting And story and GA retina helped but not to this specialists out I

patients The in more other treatment, have that closely GA at and ] eye that patients that there's thing just have and [ AMD a fellow observed. I been those eye them the have their we've seeing is that we're all neovascular looking now wet previously think seeing that been -- we one

So number to in seems and patients be the of more practice. my greater, to be continues

Operator

Our Sachs. next question from Goldman comes with Salveen Richter .

Annabel Samimy

is on application Two questions us reexamination the the SYFOVRE. on EU of Elizabeth from of This for Salveen.

So first, you rapporteurs noted new speak there's that revision? the them that in to you the had revised addressed. the identified? perspective then rapporteurs And rapporteurs? could curious a been respect to was if you with providing you to Could have new of included compared And first provide ensure what secondly, potentially key color them questions any set just are if to on

Cedric Francois

Thank you, Elizabeth. you. Great to hear

works the revision, the as important relates don't how of of but it that endpoints. atrophy that geographic on and to understand course, detail, we provide disease this So what's functional first, is Educate, to to

analyses These We are to have, a now. view, presented. have very we as you provide what mentioned, new new have we going that's And X available. rapporteurs fresh

generate in continue study know, as GALE you We well. as data, extension to the

of based our we large So but that the have on we with hope. we will what But not forward, that throughout and we maybe focus course, always path by the strong set, label, look, is as new concessions present these believe we to and making rapporteurs, prospective more now on with some data prespecified a -- in very said, we've we trial. evidence, what gathered

Operator

comes Our Yigal Nochomovitz Citigroup. from next with question

Yigal Nochomovitz

an pointed for easy Great. going it's out appreciate, battle. Cedric, it's you I not to as uphill reexamination the CHMP that be

You've mentioned the microperimetry data.

have electroretinogram, could shown metric, post-hoc in that? very It's us it that the the though data Is think precise a retina. in functional or imaging discussed include potentially in don't looked about. could that is there? of don't benefit, the even measure activity Do the a something the there the future support the you you another you You've that it you've the that which in BCVA? see post-hoc, you could you data. ERG. maybe I electrical any BCVA claim There's before, talk Have at

Cedric Francois

Thank you so Yigal. much,

examination to hand a can it will atrophy. talk use functional look of Carolyn a next, that about a I with resolution that type Again, to could on not is there's geographic what comment understand, I like problem that from in ERG, to So you over that but response Caroline more.

on data functional patients, is microperimetry important right? it's have. time, here is that, And very that What the longer data that have the again, think treat is see also benefits the you and that strong, the is increase in we more we you measurements I over that reflected these

we So package. of put that that together in all will

don't time, part that I to... know we what will can equation. Caroline, study But consider do definitely want this will but in if is That we to clear with We package of -- future prospectively. strong have I you to take now, evidence that continue that of course. everybody for the a for think is ERG something not

Caroline Baumal

used geographic ERG but data absolutely our Thank more an response used gives very like It gives a something studies ERG fashion. that similar growth diseases. late. for directed sort actually, for you. to something for to is function inherited-retinal is is and clinical of But less microperimetry in data a

SYFOVRE parameters present it's I microperimetry, has which imaging about the in of SYFOVRE we've picture to story of at is what talk SYFOVRE looking this, think And overall growth We about of meaningful the when reduces parameters, add. at the for data it's meetings. is doctors how other which meaningful. meeting. we and we the loss And given functional is then AI that all the parameters. itself highly GA, at clinical alone have, the we about talk that time-to-vision We talk very

it large the in story EMA it's else the such educating have EMA to no physicians. And a the on just of amount robust the really the SYFOVRE that one So I microperimetry that has the entire speaks think group, and presenting really we to story. data really patient and

Yigal Nochomovitz

Adam. one Okay. for then just And

Adam, is XX% mentioned, new that that that out, just you Or You is share. possible? starts? the Or Is if existing? everybody? split Can that

Adam Townsend

share. that's total the Yes, that's Yigal. -- Yes, market thanks,

GA So we're drug. leading the #X

Operator

comes from Raymond next James. The Steve question Seedhouse with

Steven Seedhouse

it as parameters specific launch. pertains of couple a about ask to to wanted spore the I

or you can comment world. in discontinuation real persistence First, the rates patient on

X it And the adjustment just average dose thinking the What's between closer as or doses. X well? interval? to about be Second, price weeks or to also of we net net then gross interval weeks? Is sort should

Cedric Francois

Maybe will Thank you the then seen with talk we've continuation, comment Steve. on and briefly and Caroline, Adam you, about [indiscernible] the pathology can what this

Caroline Baumal

a I've a Overall, that it's little actually, are majority that I can so in in I for from at group hear X injections from ], And comforted real innovation. often highly more year -- a following anti-VEGF, use variable. to their are over they years. was think the exact every high found There the With and treatment ] levels motivated. world one what some and to what this the number looked it very might to patients with that patients patients dosing not that returning are is we group seem follow-up. weeks physicians and be of very physicians receiving [ large [ of client that X But ways, be be the seen retina

Adam Townsend

Yes.

it's the Just parts got year. the Adam. We're in on first to Steve, build still of that, just too. -- we

as committed found treatment we described and are patients the to the beautifully. vast So a Caroline early really just majority in of that launch, receiving

we impacts, cetera, are dosing, X and other weeks every particularly tends around, think range to to the appointments that X that your move physicians closer of It with second to weather allows question, et the flexibility vast et majority every ] I weeks. So month [ part cetera. skew to of to X being seeing

a that to advantage believe are that every that question truly to I'll month choosing X hand patients majority vast So of call weeks, it, to dosing, the over is for gross Tim. competitive real, frequency. X and the we as other real the us. net we

Timothy Sullivan

Yes. Thanks, Adam.

to of terms we in on guide net, gross So don't that.

our chargebacks, between and was of the laid there that. say it you ]. in over is think That's going EMPAVELI. sales both and we sort the related previous to XX%. yes, provision that of forward. I and fees on discounts can of rebates our the And SYFOVRE blended We guidance towards something government out, has of don't XX% that historical have other that pretty midpoint returns. gets good a is [ do But disclosure see you basis. current a disclosure, kind in of year past year some middle in what the But the what But to XX-K, and terms and

Steven Seedhouse

in clarification I I prior to just you I just Because because to increase it curious, was what? see to Adam XQ you XX,XXX was quarter. just down, [ mentioned, relative relative that so ] sampling like relative think, in it XQ, relative sampling X didn't -- or think, to XQ one the have X,XXX far. in reported I'm is

I'm reference So the comment? the for curious just what's point reference to what's that

Adam Townsend

a was you. little I I'll surprised, Yes. be with honest

were Our to assumption -- January going this us. and had, first February, recertifications the right, new where we've is

relatively the to process. think because sample efficient It a not we reverification our assumption reach prior some increase. during dramatically. that were think would So in But I that sampling that's for did through relatively this increase that I It getting versus was rate was process. not QX actually physicians And our did flat. too

on up So prior something turned be out to my to those wrong. months assumption going

it be with continue. these to do tend SYFOVRE reach I for expect flat very and easy new it's do be for sampling for to continue samples get expect -- as quarter-on-quarter accounts drive less to to to accounts our So they J-code, reimbursed I we start, to Cytori.

your question. answers that hopefully So

Steven Seedhouse

Yes.

Operator

with comes question Colleen Kusy from next Baird. Our

Colleen Hanley

And A VEGF with comment wet those same those the patients injections Caroline's patients are What eye? SYFOVRE commercial on or from versus the AMD. then an SYFOVRE on of patients to share following about staggered? receiving bilateral injection Or are and the being progress. couple on of typically X injection injections X seeing questions us. you on Congrats able in day? their up injections get Are

Adam Townsend

Adam. Colleen, it's

our bilateral see So be treatment usage slowed And yes, that piece during the launch. were a core episoovasculitis of to [ we expecting did we ] down. last year, obviously, rare then bilateral

We return bilateral to a are seeing usage.

and physicians administer they see eye change start then little move bit progresses, that approach the We and are their potentially how and in ] [ they they'll they how to seeing eye. weigh second with bilateral, a X

usage So seeing bilateral we are increase.

patients. very positive on really to you those as conversations want physicians understand with add to be benefit drug profile bilateral? of as I the able start to Anything, and think have Caroline, this risk

Caroline Baumal

generalizable have retina fortunately, there's our like that one work. we with on to formula, with patients common between But treatment with the will flexibility. other I doctors think and different if label. treatment X anti-VEGF need have same treatment thing including no retinal really they this the I label our how that have And say in do interval SYFOVRE eye to doctors very that it's day. eye in very products, in the flexible

to for tapered it what works patient. really can your be So

Operator

Our from TD Nadeau with next comes question Cowen. Phil

Philip Nadeau

on the market. U.S. couple A

those patients using vascular where was use sense What That's physicians still using physician no did using right but summer, stopped the not X/X Do numbers proportion I a new a physicians were patients, SYFOVRE of the today? are change. there events to stand versus first over X/X how continue survey have about their think what of First, returned proportion that of found, showed and X/X, then you normal? question. the you have after you SYFOVRE, stop

And Yigal's. follow-up question, then second to a the

Is do On the data it the issues? XX% share to? [indiscernible] you currently is enabling it the is versus data X-year the that what you What attribute the that Or have? think that X-year XX% do have you you presented? execution share,

Adam Townsend

Thanks the question. it's Phil, for Adam.

any the we thing done wave since that SYFOVRE yes, So use haven't One segments call, new research of to what X/X, the, anecdotally the have started seen again. X/X, last those have of we is I each X/X.

-- those step vasculitis, ready cases being spent we up. back we there. stopped were rare we transparent don't were segment about with So really have that And physicians were of incredibly these physicians. the We those We once time and waited.

to a we've patients restart. know had benefit on the that those of had benefit-risk this that drug. have started growth we've new so started for to accounts "No, not continue Again, based drug". again patients physicians I've new in did They couple stop. stopped to profile of the that continue see we And Saying of the of physicians see the of, said, see only. that I And anecdotally segment

don't have research, impacting we again, whilst do So -- haven't X believe those we're done that segments. market for really way I

strong the the particularly We've of last team, Now the it's I execution months. second -- from right? a lot few question, Continued the part XX% over is things, of with time Physicians to see the of profile. a now, community, transparent I and clinical I lot renter confidence. incredibly think benefits spent believe, the and overall truly been our of down building we think your trust

since long-term X real-world are So physicians, doses to efficacy as from leaning GALE, the safety I've X over vast towards weeks. before, this and majority of flexibility, launch. Dosing said is XXX,XXX

with our have from X. We October payer coverage J-code strong

efficacy, all it of coming But profile I I think drug, forward. its is on have And those moving vision this it's can together. high. of choose things a think, the patients' for efficacy the impact this you up stands drug

So benefit benefit laser and drug communicating with we our are focused this physicians. the risk on of

that difference. anything think a make will Caroline, want I add? you to

Caroline Baumal

it's more to the GA and That's And dosing patients that's into is growth. something that every a little GALE lesion in they meaningful. in The function other like from of to data the month with with visual so up really efficacy XX% think reduction just fact hone data GALE on includes I non-SYFOVRE is X this the that fact appreciate we so years have that story. data thoughtful now also up amazing. to that

company who initial for in reaching the study, So sort are experience in clinical all story that was who which are community. the the large product, of the first their we're where the now. were now of using came physicians with so efficacy that's physicians and getting patients and the is then physicians other and the experience doctors our experience in thing The

Operator

Our question comes from Jefferies. Tewari next Akash with

Siyue Wang

This Akash. X We is ones for have Ivy on just SYFOVRE. on quick

to like team felt and [ XX XX the you and ]. that could heading spoke ], long-term [indiscernible] around we SYFOVRE between [ when So train confident have our the split be somewhere

taking call on term? you [indiscernible] how X long XX-XX then you in quarters? you competitors have that of split given SYFOVRE haven't in you secondly, maintain for share currently after XX% quickly, do feel why And can that later is comfortable guide months So their to And guided just launch, plan market commented this the do 'XX?

Cedric Francois

you so much that Thank for Adam? question.

Adam Townsend

Ivy, it's Sure. Adam.

have discussed they estimate can previously, market said, market share. But [indiscernible] a ways you XX% as I are yes, there share. So as multiple

specific vials total using is [indiscernible] that is shipped a time for assumption period. Our

market is and their So which analysis What looking this snapshot of analyzing data, we a share. think use physicians market our ECP at than better or ordering And using current are a there's quarter last of that total the And versus market would real-world where injection we vials. injections last rather quarter. do way is we revenue. vials It vials is do. obviously, actually we shipped actually counts a

GA drug So there. #X we we're confident are that the out

time-adjusted you on physician they launch assume the competitor's the day, launch. [indiscernible] of if time We our was also or And demand a versus launch ECP did in that same first analysis of SYFOVRE launch. of both you Xx greater that for adjust X than the months

So an positive that's metric. incredibly

another X.X right? that patients We larger that new mind million. on majority is continue from to X just this ] patient the market of Keep SYFOVRE. also And in believed than of see million much [ we point, starts be

believe I are expect product, think leadership it over that #X maintain we time. can and X to truly that we accommodate more we but the than product.

Ivy. your So hopefully, answers question, that

the I'll hand [indiscernible] I to think for Tim

Timothy Sullivan

I'll take the guidance question.

we past So guide year, before quarter point, recertifications And the time where felt a had first we've we in case could more little we or Obviously, been we needed never through after a the effectively. like.

to and and So dynamics we'll we back Thanks. year, a over take make plan to on understand sure we're course our the when guide. of you we going time get to just the full

Operator

next Merle comes question Our with Ellie from . UBS.

Eliana Merle

I up follow all growth on asked the want question Congrats earlier. progress. the just quarter-over-quarter to on

of increase. did seeing X in months rate since the and strongest the as not you're and launch February January As sampling

we XQ? than guess, Just want clarify be that that question. shouldn't balance And just So seasonality second higher on commentary? XQ point. a the with how do I then to

frequency seeing types dosing and dosing any sites owned you private different compliance trends such of academic? differences versus in or In terms at are equity frequency, compliance of and as

Adam Townsend

Adam. Ellie, it's

impact So does market. yes, been seasonality so -- this drugs we've within

be X on from to and analogs We February the weather. largest I into likely said, the a our anti-VEGF. of week in we happen months. and used do January that did We believe that lot February As the found are see January I and recertifications impacted

flawlessly So how and physicians. pushing incredibly make as being possibly it interact QX in we with as be these we're to can executing by thoughtful big

team pushing we're is And proud flawlessly hard. of I'm executing. the So them. incredibly incredibly

#X believe have We us we the expect moving would forward. GA drug you As to.

Compliance.

I for X tend patients and to see majority be vast the As seem X very touch compliance. comfortable said, weeks, it's to that. they to of being a early We with

have noticed practices. any compliance difference We versus aware I'm backed between of and practices not non-PE that PE-backed

the in rest wide business To practices. about differences those -- practices range nice a knowledge, groups. any business. The XX% and seen our practices have compliance haven't of from XX% PE-backed we terms We my independent of remaining rights. academic of are are

I for we with drop, X said, first it's as of the think X exited when compliance, get that. to too we into years that's patients treatment early their a just have conversation that will and I year, physicians As this but with have

Operator

Our next Brisebois question Oppenheimer. from from comes François

Unknown Analyst

[indiscernible] is for Brisebois. the This on Dan market from physician to segments question François regarding the Related research. a

to X/X starting effective see sidelines? physicians J-code permanent Now are the GALE that and segment within impact are extension of with the readout, the an you on who

Adam Townsend

Yes. Thanks question. for the

physicians starting are the the that. of So see are haven't who sideline, on market all unlocked but to impact redone J-code and we research, that from yes, we obviously,

continue it's metric. -- my favorite We

are see to start no SYFOVRE sidelines physicians these We sign has starting new to on since to tells longer use up accounts want That every that keep week patients. continue double-digit that the launch. to That continued. you

an I positive us. metric for incredibly think that's

who whilst anecdotally, target too, go. XX% our the yes, of we're started physicians across We opportunity, about of the have that sidelines X,XXX do on potential done we we have So That's haven't those some care hearing research are about So list. U.S. have the upside right? sites to

So the that, year. for that some move to execute and target have of the the and of half go we started good market, plans opportunity an there's expect first rest the growth which quarter in to us into for the and we -- other for to still

that answers question. hopefully, So your

Unknown Analyst

Understood. Congrats on quarter. the

Operator

comes question with next Needham. Our Joseph from Stringer

Joseph Stringer

potential Just quick switching on dynamics. one. a

if you're curious hearing qualitative and or dynamics between or that Just feedback far switching on [indiscernible]? metrics any so data you could any provide SYFOVRE even

Cedric Francois

vasculitis, briefly shared the where mean, the stark, has I think rare expect risk, to products risk discussed with that versus know so [ as second between extrafoveal we the hear on ], patient out glycol, will the firmly competing believe safety, day, Yes. and on on that positioned is ] the difference what been is something product. XX% products. developing treatment And something on future have it efficacy, quite do our is I the so maybe it what towards At quite you metrics to of with well. as the in polyethylene comparator have end then will place safety, great And the that is allergy reason that the when the right? efficacy well is the a you right? to as associated which planned. on we to even before, want first on something Adam, that that? then of injection risk you. very mentioned -- will have be for year Thank I much. stand is Look, slowdown That as to that to is reported both don't well between we caused a very though now every the the rare, where right? we add So up patients, will is far exactly exists by pre-existing XX% that frankly, [ is are in

Adam Townsend

Yes. Joey, it's Adam.

surprise, We no switch. to know And safety. right? accounts are. see rare the some we primarily cases did switched yes, year. accounts last They So where of those vasculitis During

physicians Now back. seen switch again, patients anecdotally, some actually have I

from physicians patients switched field the teams from those some And So heard back. to competitor. were of that then seen and my have SYFOVRE I switched

benefit happen safety rare that in on So the every But truly communicate we happened the in this market. and risk this sure the of during focused It in the making market. efficacy vasculitis. definitely we to profile cases switching the we this profile, drug and physician will does be believe and of

Operator

Derek from Fargo. comes with Wells question next Our Archila

Derek Archila

line first, NPGN? launch then do and is setting strategy overall today? impact I there commercial And for EMPAVELI. guess you CXG you you in I XX% and seen just kind PNH? in from on think And much of discussed Just first EMPAVELI X the the of the from [indiscernible] have any upside guess, -- how

Cedric Francois

Thank you situation, competitive It's Derek. a expectations so very in we much, our competitive you. be commensurate course. now have PNH, should And that hear great situation. to of with Look,

don't ] there be So will from products. oral guide, while pressure we certainly, the [

of this. a the go in in is general, products a thing I problem back patients. us. to as that already extravascular a was If years, majority hemossis they're X you X% the of this is And these This not of will That is have be around of the in helpful. though, affects was available notion now that recall, patients said from benefit covering we affecting big there that think may that patients, it are that something sense, There and will raising these to and overwhelming couple segment something true. a because can patients. of great awareness address that

excited are need. X,XXX As this be the about we've in TXG patients will want mentioned to what you the that that? can CPG the do in with summer to do what trial Adam, and and the for before, kidney we able we're something we of readout add to VALIANT do incredibly to

Adam Townsend

Yes.

be for patients just appealing should oral Cedric, well, but twice sure. said extra a to Derek, really we few day that. it So will to bits, You add expect right? a PNH

aspect committed to benefits safety our EMPAVELI. the improving we're from twice to expect. seen you the injector, we've majority efficacy. really fact, are the injector, benefits patients oral, the a of as see switch that EMPAVELI auto drug. would patients EMPAVELI The In the X And day the or They vast of the of X of see profile. with They the convenience really

strongly in going the competitive will market, impact. an to we're an be oral So but have

about we be and time for ] physician the EMPAVELI. conversation a a every a between opportunity around line first-line that asked I block the oral market, expect that [ is the have been XX%. And used But patient. a I've right? do little I segment, there's the will segment. bit. a an do So within expect first You nicely into new entrant and had It's

has oral about consideration is physician from for ULTOMIRIS that starting that SOLIRIS oral, to set. or in that patient a an with a or [indiscernible] was an conversation on So us a switching make opportunity to an sure EMPAVELI

important opportunities switching during us phase. particularly So for become this

And execution on perspective an just nephrology.

EMPAVELI affairs conferences, conferences. the face have send team And see affairs discussions starting mid-XXXX. cetera, So based will We're et medical that the we medical great we have on obviously until nephrology to team. data be the nephrology we that some a that to these of

Operator

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

Douglas Tsao

a as there follow-up bilateral maybe Just during vasculitis on was treatments. Presumably, a slowdown the days.

big should original terms to are we some relative smaller So catch-up. part we sort and starting it of how a think business of expectations it sort your that the that was, is of in see of of to

X And are that demand treated, pent-up about getting sort convert patients of bilateral so that we only most should SYFOVRE of some are eventually as think who likely amount on should of treatment. eye but to

Caroline Baumal

they or injection these the and physicians it's for once come and first they once. just that to think are past so, be that using comfortable have I -- likely to out patients only will of will for patients in gotten convenience have patients bilateral

approaching robust we that patient now I that. have the vials think that So we're large have of that used experience to been date, a and number such

Adam Townsend

Doug, Yes. it's Adam.

to add. Just

start definitely as I to to of that come impacted, usage communicate think but be it's I time think the you we with bilateral said. back, delayed, was as all right, to expect going I do what these it impacts opportunity. they practice They've last do different the injections, on process how it is year. I changed on how think bilateral their of physicians. they happened how based the don't

as just physicians comfortable. time delay I think more the get that's

Douglas Tsao

[ And originally single we of eye about expect is ], having treated sort you No. are question just might that eventually should Yes. of when on I think was my proportion to number a than but a presumably up. higher those have anticipated, SYFOVRE patients certain think a catch today we

see per So relative to on a are. like patient we vials where should -- we increase

Adam Townsend

I think yes, should bilateral expect you increase, forward. moving see to

Operator

with question Securities. next comes Our Zuho from Suvannavejh Graig

Graig Suvannavejh

quarter. Congratulations on the

just Could question. or process. have view on X previous Or clarify it submit repertoires X, is this And whether during period me of company first just are second fresh reexamination in new please. original to missed reexamination please. One, a whether but that the I new as data you on was before, European this So a dossier? question, provide that's analyses? able you my data my or additional the the might just the then Just included

potentially in the it either the increasing or on the a of rate of same? profile vasculitis is Has Just reminder Or SYFOVRE. safety change terms decreasing? of essentially

Cedric Francois

so much, to very hear It's you great you. Thank Graig.

analyses, new on the data new that are European all, done that First but include Union, data, of again, you right? that really not we microperimetry allowed to is our really especially team compelling. well. something you are the so So is has allowed And to include

So it's happen, we that. we'll we as are that to that take one uphill see an what's going battle on to excited mentioned but

them for speak continues the the being benefit in has with of be from versus to risk of good what to at since course, front stability they when that context a As on relates to the to it can it the safety, their rate patients it disclose provides that July. where been treatment. very physicians And them X.XX% is to get

to for become this change quite going Again, unchanged. have to [indiscernible] so manifest, we're that So to wait are bit. rate a rare a

Operator

questions to any not like showing turn I'm back I'd at And for remarks. closing over to call time. the any Cedric this further

Cedric Francois

for you. all come And that forward we much and much, more available for start today, be year joining. will and for answer you Thank so of It everyone, look is take any the to great Thank inquiries those you of may further later here with to by. us, questions a you months to sharing you we the have. as

Operator

presentation. today's does this gentlemen, and Ladies conclude

You may a wonderful now disconnect, have day. and

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