Apellis Pharmaceuticals (APLS) 10 Aug 212021 Q2 Earnings call transcript

Company Profile

Participants

Meredith Kaya	Senior Vice President, Investor Relations & Strategic Finance
Cedric Francois	Co-Founder & Chief Executive Officer
Federico Grossi	Chief Medical Officer
Adam Townsend	Chief Commercial Officer
Timothy Sullivan	Chief Financial Officer
Anupam Rama	JPMorgan
Umer Raffat	Evercore ISI
Madhu Kumar	Goldman Sachs
Ernie Rodriguez	Cowen & Company
Alethia Young	Cantor Fitzgerald
Justin Kim	Oppenheimer
Joseph Stringer	Needham & Company

Call transcript

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Operator

Ladies and gentlemen, thank you for standing by. And welcome to Apellis Second Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised, that today's conference maybe recorded. now Meredith hand President, Kaya would to conference Investor I speaker-host, your - Instructions] like the to over Relations. [Operator Senior Vice ahead. go Please

Meredith Kaya

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

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

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

Cedric Francois

and everyone Thank us earlier great to afternoon Meredith, joining who Also Investor today for month, be you, good Apellis a Meredith. conference call. Relations efforts. welcome will And joined leading our to our this

The period nocturnal treatment approval second label targeted and with for our of the Apellis, highlighted broad the therapy. which with represents pegcetacoplan, of adults EMPAVELI EMPAVELI community transformational first for and Apellis, medicine it exceptional proud of And PNH. XX the this I very CX is a for team new an complements for The achievement medicine. EMPAVELI nearly or PNH FDA the approval class was of for the am hemoglobinuria, years. in was approved by advancing tremendous or of paroxysmal was quarter first a

The only approval the more Commercial Officer, where R&D CX therapy strong results targeting a across June, additional the patients was to possible quickly targeted naive with is patients. PNH. and start elevate PRINCE treatment our our Adam is details by results the standard-of-care good hosted of and showcased reinforce growing off for the positive of potential news CX. Chief neurology data, Day with PNH share an by is Pegasus And from phase we for study all ophthalmology. pipeline our PRINCE launch commercial in what PNH Our the disease, with the followed In Townsend, Together will EMPAVELI X EMPAVELI to rare shortly. we start,

Our global ambition be that to in modalities to long-term, entities a several multiple over we is new complements unveiled goal. the leader across on deliver and molecular

plan for number help indications, In of experience. be world-class results advancing addition and diseases we to from our the a pegcetacoplan ophthalmology, And a to and role aim our neurodegenerative new for in where in of team with geographic to complements programs CX the these by CX treatment existing enhancing to targeted we phase and partner, retina; we further the diseases. is in registrational key patients or candidates wide plays look forward conditions, product therapies EMPAVELI new with rare where urology, GA. driven pioneering patient range research Sobi; then to transform the devastating developing In one atrophy X

GA for diseases. Beam's to editing, treatments molecular AMD. base to technology editing AMD are research new with proprietary-based with Beam and our announced In addition, novel together Day, with Beam. also forward compliments intermediate apply exclusive for is to we entities R&D we collaboration advancing for Therapeutics discover novel frontier working driven a At we and an Complement look

that and modulate silencing the explore approaches will base eye, brain. to the other the We may the and potential in editing, compliment have liver,

curative a one-time therapies develop of diseases. to for is wide vision range debilitating shared Our

Apellis today, global We we in extended are leader to a breadth with which thrilled complement our in the positions and the pipeline, and the depth tomorrow, of future. believe be

of treatment wet and worldwide, The with heading the GA, of to are Looking develop pegcetacoplan, OAKS GA. from million Retinal first event of GA. atrophy majority great people Adam? Feedback of well for of living enthusiasm treatment commercial phase patients key about DERBY having than from for This transformative over will living results more shows as whom the EMPAVELI more a our Adam September call potentially for to X Community for prospect top millions launch the is finally for turn line optimistic the patients now the currently potential for overtime. and AMD, in will I X with readout pegcetacoplan the into we studies ongoing the with the Townsend ahead, the of PNH. as share

Adam Townsend

Cedric. you, Thank

I'm off launch to received are made the is As XX, are from and we share Cedric so the May said, that on thus EMPAVELI our EMPAVELI by we've community. very our we've only beginning was encouraged the start, the stages. great to in and approved strong a positive excited mentioned, With feedback commercial progress results. initial far, PNH we

with patients inhibitors, Ultomiris, designed Recall another both are are with XXX naive inhibitors; eligible currently launch that new treatment. people we label, which EMPAVELI PNH and currently being that those have to Soliris are with are top XXXX are within every and to EMPAVELI year. being on approval; Our wants slide, who the who there the patient Beginning every to all CX access treated patients this CX this important who approximately and included treated priorities thrilled PNH were medicine. of will diagnosed the ensure U.S. which with outlined with

anemia patients of whom levels. who to PNH beginning Our their CX like symptoms community, the on control falling address initial broader suboptimal require highest patients with disease, transfusions their from then with signs the unmet and PNH and also suffering hemoglobin expand many have need, fatigue. We to those are who of inhibitors on plan focuses of to one-third severe launch

than of indicators of that we PNH early only REMS also are for in the the but on have EMPAVELI can have launch of slide that the over various have address positive their from We identified highlight physicians the U.S., needs. patient's signed demand, the up better our for XX of side July, more At treatment from these feedback excitement since the forms. physicians Program received stakeholders, not and the have EMPAVELI help Each community. right end received quotes and start XX

We are which about CX majority coming new patients of starts, are Ultomiris. switches of inhibitors with from finding XX% the EMPAVELI that

We have start diagnosed patient newly also received our very forms, is reflects which level. broad and encouraging

and coverage Medicare In terms private channels Medicaid commercial and prescriptions. three breakdown, EMPAVELI XX% approving pair with of XX% approximately patients have have of XX% submitting have insurance; all

pair priority front; Top payers, the XX with PNH payers our private patients. the for programs and and the expect value XX-XX And future. all coverage cover split including remain XX% that We of on payer access insurance to engaging high between lastly, is approximately government foreseeable U.S. team

in EMPAVELI positive four formulary accelerated far payers one position. have So formulary has already reviews, and EMPAVELI a placed

excited progress product To of launch we our are on-track bring close, on we to to super the be plans of the and strong to to strong Given the are end XX% the initial community. PNH year. formulary EMPAVELI this with important date, approximately new by about of proud are

left highlights are from Some the of of the I activities outlined side our included slide. this launch on

on teams team, marketplace work to affairs, lot from laser successfully launch. done focused medical executing commercial and integrated our the to a the have of the is field prepare We

physicians, engagement, you accounts satisfaction end of goals all self-infusion side as year and On priority can patient the of this of engaging scores slide, maintaining XX% for of see well priority and high EMPAVELI. access This patient market right as for includes experience.

updated during we up sales illustrate the continue plan this as term, do ramp provide in forward progress as we initial metrics to that near not to to trying period. teams this to While the certain community. look are to provide work transformative bring our treatment our we launch We PNH you guidance keeping launch to to help

patients high time, proud to our looking unmet needs. help very upcoming the phase organization forward PNH XGA is to team commercial with same At have Apellis next Our results the is responsibility to the month.

for busy are opportunity. teams potential clinical over the blockbuster international turn preparing to now this Grossi globally and developments. Federico European our US, to call commercial will the Dr. I review foundation Our

Federico Grossi

to Adam. which and statistical with of clinical CX to as profile steps. superiority versus treatment Those of standard-of-care include EMPAVELI result EMPAVELI with the are prescribers PNH. I'll standard-of-care, in EMPAVELI for of report the also profile use at inhibitors phase that a statistical our EMPAVELI the you, the study from did partner In co-primary to PNH. line include consistent patients. early safety therapy thrilled top naive improvement need positive targeted endpoints robust hemoglobin superiority with achieved all May results on not briefly study on week These we levels, removing to data and several of brain treatment patients. complement X begin Sobi add meaningful XX. secondary the The endpoints and in our compared transfusions. pin the Thank we're EMPAVELI demonstrated adults support in for previous was

with registrational ongoing planned Sobi programs PNH are that have we year. h, EMPAVELI Beyond start four either or this of to

focused programs our providing by diseases, our are treatment watch product comprehensive to meridian potential hear unmet the remainder and EMPAVELI component. driven are rare differentiated slide, offer Our no on CX the few website diseases. potential on treatment a are we're The three control has encourage initiations the data, study of these targeting believe ALS. of and options. by on from milestones year study profile we for disease clinical the that for supported patients completion to on the I And or you recording where suffering in leaders the IND component the to of patients need be opinion key upcoming transformed several from enrollment devastating outlined the day including

[ph] Turning now pharmacology our to franchise.

X results this are previously in September. intermediate As tabular phase mentioned, pegcetacoplan and studies the from OAKS DERBY expected of

XXXX same the safety As as pegcetacoplan, of sign seen pegcetacoplan study month and can every studies we endpoint both identical, be inflammation. randomized, full shown the the of with on the that monthly details The profile safety present intermediate monthly is activations results on reduction XX. in primary patients with the of the in OAKS GA. efficacy plan multicenter, DERBY for the studies well month including compare treatment September, every other other month and In growth arms GA to slide. the and rights of lesions primary this slide, of intraocular control The endpoint as and are on of and

Additional masked data meetings with studies And are primary training the this presented year. till month-XX. at the be be groups from analyzed continue medical to will will studies later the month -XX, at endpoint expected

Secondary tested will only be formally at month-XX. functional endpoints

Finally, currently no Pegcetacoplan a approved I'd our to for plans in intermediate treatments. disease AMD, like briefly discuss has that

on progression an of and As delay opportunity the a to loss. patient to analysis patients receiving AMD regulators prevent AMD of These AMD, lesion regulatory phase compared and from continued feedback GA the demonstrated hoc post outside intermediate study currently the significant lower GA forms same seeking SHAM. study of X a The the have advanced GA research rate represents to retina prevent pegcetacoplan support of or from intermediate to potentially areas progression in results we're pathway.

half study positive rewrite Following of initiate for first I a turn expect the now we in pivotal of review the call will results. year. to next Tim GA a financial to the Sullivan the

Timothy Sullivan

you, through I between quarter of the XXXX. revenue on a June second financial full the press quarter with revenue the product of for XXXX. Since FDA six highlights the focus was Thank issued XXX,XXX This recorded for release in XXXX. EMPAVELI product reflects just first Net on Fed. XX weeks earlier today XX we May second results, approval will of the

the R&D to and related expenses inventory in affairs costs of to quality in by due contract the a quarter manufacturing will the in following include $XX.X beam second associated Research to was R&D of Development the transaction, period capitalization with contra the and personnel to FDA EMPAVELI offset and same product increase planned attributable increase in expenses, The as clinical among as associated expense the expenses were quarter others. additional of and million Sobi the collaboration, decrease full for and ongoing hiring were revenue. trials with quarter XXXX. first net $XX primarily primarily XXXX expenses, million personnel EMPAVELI. of payment medical of compared costs XXXX, well $XXX.X in of third R&D million The the the approval expense

was to trials and number the increases to General increases. patients the and continue trials million our general XXXX expenses of in same activities, and in consulting to We of related employee conducting among quarter administrative professional in attributable for in million $XX.X costs, preparation primarily administrative XXXX. increase of general compared to second expect increase were R&D expenses number as we expenses the the others. $XX fees, commercial The and period are

in ended same quarter June period million of of second the a XXXX. compared Apellis net the for XXXX XX For a to $XXX.X million net $XXX.X reported loss loss

cash, in in advance cash had As to of plan. and XXXX, $XXX to equivalents execute EMPAVELI June the short clinical well launch development securities. our on of PNH, and Apellis marketable robust remain ongoing XX We continue million term capitalized

Our including into for our of operations the allowing cash in to year, and XXXX XXXX. I we $XXX.X aggregate million lower approximately turn further in We certain July, partnership. will at deliver XXXX, And of recent million into $XXX.X million approximately runway began Cedric? closing two common July and sheet. balance of Cedric for $XX conducted paid fund with now Beam the this expense, to rate In of million entered back of is June remarks. principal million the the with have now remaining shares expected exchanges as amount over of XX second $XXX January the to call notes. us X our agreements exchange the part half to convertible stock, notes to we interest

Cedric Francois

made have in slide. of continuing leader several Thank milestones as year, you, across this this We to pipeline long neurology Tim. far be to upcoming term and growing global our so and ambition on look rare to We've forward advance excellent a as our part disease important ophthalmology shown complement. progress

to open operator, the look helped top investigators, month, our next OAKS opportunity advance forward for partners, this who updated expected DERBY questions. the studies recognize call and to on results now would to to employees take us we And patients, line investors have you With We the key like caregivers, and of keeping milestone. the please progress. thank and this

Operator

stand compile the we by roster. Please while Q&A you. Instructions] [Operator Thank

Our first of from JPMorgan. the Anupam question Rama coming line with

open. Your line is

Anupam Rama

so think put here dose the more Thanks XX days taking quickly and first days. little context you might when quick average for XX said that a Hey, question. than just in Anecdotally, ask and higher being, what's that XX able when guys. slide much on on EMPAVELI Thanks prescription days. the on a I'd than days into much. a can you to get the it's XX one to I be of days terms so causing bit patient from

Cedric Francois

great hand to Anup, answer. to over you, Thank I'm hear to to going it Adam you.

Adam Townsend

have XX we're thing line question, analogs. patients that patients transition. thing. than in all XX-day your start transition. with obviously Anupam. But some days XX disease obviously they and and The transitions need everything drive the community of seems for It's Anupam. get other the our make they to before very as make the sure transition have very That to their that longer they with that vaccinations be days. question, gap. we actually tends days XX We have hopefully Thanks Yes, various and quicker sure that We're much consistent to answers they with main is happy working the hard that rare than slightly to that PNH

Anupam Rama

Thanks so taking much for question. our

Operator

the from coming Evercore is ISI. with question Umer Next line of Raffat

open. is line Your

Umer Raffat

that have wide-AMD X on in when worsened. But much data out themes wet you then that taking the Thank one Cedric, my much. your in you understanding phase you BCBA their folks your do so Thanks convertors baseline? stood of the have as Xs, question. did the phase is in converters non-leaky AMD was CMB one at very wet AMD that microperimetry Also, guys. remember Hi, conversions; convert well. What expect microparimetry? X would technically of scores for of FILLY out phase I what XX% my came percentage had

Cedric Francois

the you with Thank all, CMV. first let's so of trial start free the much. Well, non-leaky and

called when extraditions. we retrospective the the looking So at FILLY we CMV, had of patients so at were and for analysis that did really background what the In the just was a on line. a people bit trial, looked

sometimes were neovascular missed. these the to available, The in from at leakage not sitting of this up because can screening? be. is, ourselves supposed the we the with That where membranes at essentially they're retina, of but technologies question So time is picked the asked beginning membranes were neovascular there not the happen, study

indicative So, there the the is is we the from sitting the a something called being layer double Brooks of at that cell we sign, on retrospective layer, did leaky. what of LGOCT; membrane membrane RTE not which but looked separation analysis

became in of percentage that. have baseline. trial that, double at when but showing FILLY to that it extra around the Now up developed a that believe it was look layer back had that for I of that ended trial, clear patients the doing patient days later large that the sign will exactly number, the during I the XX%

patients but neovascularization. the to FILLY results. that's Then further interrogate very So coronal relates as trial interesting that it microperimetry to it observation the with X those as in we far of relates with phase as will a course, the

will So actually do macula. know peripheral areas phobia here, the place, But shine microperimetry. laser atrophy or correlation; not a ability geographic the is be [ph], don't there in see exudations light a of functional we where in with the to so on FILLY, is we kind where microperimetry did so you way associating of outside an really the growing. so is impact of microperimetry; creating an a examination light microperimetry, of again in is of in areas And whether first

the the phase really of really But not we'll look to again, itself, in that. related first into the time on So, have X, to CMV. surface

Umer Raffat

does rate any phase and/or that's before this what you being what phase converters If Cedric, or was that guys conversion out, that all confirm have mean have to you of is call then. and data not I hearing AMD wet since have X I'm based seen? wet a comes basically X digits? layer happened interim can blinded the just right. interims us Also, just remind want mid-single XX% phase the your your last the double likely used on follow-up at X, that maybe had in baseline, analysis AMD

Cedric Francois

Sure.

any to we a of have repeat the is closer please? up deadline. the the last the in to was insights respect part that, your Then bit, something don't come question, breaking with when we're little it that end, it will as first middle. relates you That the question, could to Just

Umer Raffat

that wet FILLY of the used in said conversions layer been basically high mean remember would that's first phase apply AMD wet right? question double already the X teens of teens missing XX% is had had AMD is the at phase X, double considering, high in that you baseline, phase of that new X; the definition The we if part latest rate how and only conversion layer was those

Cedric Francois

of and the Again, you definition. in between where down to kind That difference comes leakage the No. see coronal retina. neovascularization excavations, the

discovered With subset a phase may in patients patients. on have only to does exudates the very whether wasn't there neovascular to patients, point leak is the you AMD, angiogram really a really XX later XX CT. it out done we membrane. there you the answer may fluorescent is even particular of that reported complex to X measure on, like angiography, is use that of on would not OCT way can exudates that neovascular is wet the of angiography very exam, detect detect had at is is complex. thing something know use separation being by there for and Because small AMD and XX be on X double-layer some which exudates investigators the off of that which is but only with that. fluorescent angiography. sign, a you the in easy CMV Again, wet at there's reference don't gold suspected recent you by at that that that of of that, [ph], is to you the point cases not know SDOCT that in be is neovascular angiography, give Again, to a is had a received only kind I XX exudate small confirmed retina that present interesting know important a coronal time, now called All done at to at in time point technically and based those One fluorescent screening. may The the that the on the FILLY; which to in standard that that phase screening, that beginning

So, your tests that think the we've before. reported XX exudates on line confirmed All only be what about CT, this, could in using angiography. had with fluorescein XX of

some have for Our corrected believes bias in X. there X in we the investigator that was phase phase the that

Umer Raffat

very Thank much. you

Operator

from Kumar coming of Madhu Goldman question line with Next Sachs. the

open. is line Your

Madhu Kumar

if think Hey, thanks you much our CNV back I'll mechanistic taking How events to of the for from discussions about the basic it's blockade question. CNV step contributes DERBY/OAKS. complement about to emergence question [ph]? neovascularization blockade mentioned but much of when in things patient it pigmenting you at complementing like differences bias, sufficiently baseline compared biological is investigator distribution? just [indiscernible] some How as you ultimately do

Cedric Francois

a you is so question. Thank much. That interesting very

in that phase exaggerated we saw parameters. was X important which Personally, So, One, think investigator not? based it it was real you the think I I on this imbalance the vastly just to was. or bias. two refer

steady The of baseline we the to put normal eye GA who patients wet trial, some while subjects lot XX%. background distribution the to is came whereas from the had that enrolled phenotype, enrolled contralateral the on in eye, second and closer AMD at in Philly of that the XX% numbers that on having a

closer for XX%, are, CT leaky, more expect it and more you not complexes number response, happening this detectable these a secretion, and in mentioned think the indeed We become nature, be an to be [ph] to to increased could safety which know, in we Then were and was very should healing is, XX%, have just earlier, angiography. in fluorescent and Then associated induce I wound to with they state. it small one close if a case? it's that we leaky exudates phase lead why concern. can Philly. to be the again which an Again, that why which than should X, would So, is imbalance? a always as that postulated relates a the question importantly, You not avascular then case example, that rather pre-existing observation detectable often that in there fascinating it's these our see all is as on and very was interesting

an is in repair a not increase that complement case exudation, induced response control. maybe all that it actually at implausible in with safety us, concern a by is was So which not associated this for

Madhu Kumar

about How Okay, kind Tim. R&D that expense we on XXXX? condition in - through and think XXXX should X great. DERBY/OAKS Then around and the trials a phase collaborations EMPEVALI? of GMA from question for happens How is and Sobi what

Timothy Sullivan

Thanks a lot, Madhu.

bit then, to go R&D, year, EMPAVELI our quite to XXXX of don't up we the mind consider thing a in half bit with second of bearing bit give in relating the this know, to you table. the commercialization keep should a expenses conjunction breakout and even And that us in G&A DERBY of cash also you specific we to our positive up expect our does PNH. in respect is launch you OAKS, any in of spending plan the with out end the for into to a see for that guidance of ourselves $XXX But As the little in those globally. and and of into in million for line expenses there's year we in one sufficient a items. R&D do commercial in probably good a towards But ramp read that is of actually the detail pretty get a scale mind can

trials and increase increase of addition ones study. at of an number the a have look that to you some OAKS, extension our easy the in as project we pretty which think clinical the trials, DERBY will to with in ongoing again into ongoing roll are the I mild pivotal

and that after So years OAKS. for continue three on DERBY will

decent can the over you pretty next sense two. you get things So, the can next or how look year of a

Madhu Kumar

my taking for Thanks questions.

Operator

from coming the from question Nochomovitz Next line City. Yigal of

Your line is open.

Unidentified Analyst

Yigal. for is taking Hi, Carlyon this our questions. for Thanks

similar [ph]? lesion further Darby announcement question for is ask will a your rate the the FDA were for analysis primary requested We the the expectation analysis just a wondering, and of to that FDA to in is Oak first change study. in it Our in related absolute change that slope endpoint addition area had

Cedric Francois

you to is that thank Yes, answer much question. The no. for short question that so

or not again, assessment requested a that That So unclear often analysis. as when it a the request is context may from - of be viewed FDA inspired in is agree analysis by type to. [indiscernible] from of special typically would protocol unusual the the is that what a FDA the but often sponsor

suspicion through. the that very From is in the Philly statistical perspective, we is we on trial, the I went analysis that my that full with that after had X can our the phase So, process plan I agreement our you and meeting submitted with proposed the tell protocol FDA that.

the So, was trials standard there the and in for that no what use, was chrome we among a also proposed spectory need example, since spat, FDA for the Roche-Genentech. others [ph] with

Unidentified Analyst

the how and DERBY the what to compared anything dropouts was more say and at Philly? OAKS on September great, injections some those that well. would missed visits wondering you've rate additional in analyses could topline included to past rate the for plans and in in were if this Okay, thank if mentioned in as in you. of disclosure to COVID due you impact you. conduct the of Then account just think we missed I wondering point there's be could just observed were we Thank potentially of

Cedric Francois

problem. Sure, no

impact we've the As the length during years of in tracking and COVID been as closely on very, very two half, or year was we past the injections and I in Day the we should talked have say, a missed about a before what trial. June, iterated R&D our at over

at is that that As the minimum of about feel primary and very the the R&D we give we us analysis impact COVID good injections, for on endpoint indicated approval. Day, that our analysis of monthly the analysis will

long, very where month But higher. confident course, and For four to as control. Day, for our but and a every we is of relationship that month out COVID is, to of there, be of what's we other is impact the as interpret an every trial is missed is something injection that risk of one drug long the we under mark at months one year injections, interval in feel pointed other there, approval, as could the that the need understand we DKPD R&D used

Unidentified Analyst

Thank much. you so

Operator

from Nadeau with line Cowen. coming question Next of, the Philip

is line open. Your

Ernie Rodriguez

Rodriguez you for for taking Phil. Hi, this Ernie Thank our call.

extension mentioned year. and the for you identified from think you positive any within population what's Then launch Do received GA, preclude with achieve in approval, EMPAVELI? expect patient September You level for goals on goals group the you the achieving feedback but the have this those results curious and that you GA were launch? the some barriers you will that of for on and if results? change depending could FDA the do assuming various reduction We the have and treat on of your the you expectations approach positive

Cedric Francois

Adam Thank I'll first I so then take second. will answer much. of question the and the part you your let

Adam Townsend

our are every to on that working patient We're were our who well Yes, goals is going are believe can make of with Everything we're as very well of incredibly through and with thanks can we number the the REMS, the We're number to the happy get question. very that a launch XXXX access trajectory. very for launch. and start and you physicians the tell Yes, with happy by forms, progress date going very and the those sure ongoing QX discussions. strong needs achievable. payers REMS

have you right to work launch. there. sometimes direction continuing EMPAVELI the we'll six that That's for between access remember, the to pointing to their in three continue to As to But get to on. formularies. success us everything's something We're allow some they take months

to very the we're happy help community. So, PNH

Cedric Francois

part question. second of Then in your the

of population So, do in? that communicate. research to What How I'm important interested implemented? we will physicians product two is we be something that have are well. see happy this done a There as patient it's to because takeaways being lot the that have on

patients retina to will opinion, majority, a product of GA. this not atrophy, of specialist is drug prescribe their works. is, if be then a our one on how have is first clinically The we good profile very with growth I the that, drug? safety exudation for this meaningful should is the a medicine in our going all, the Because should under effect control? be that product If well a with to that a mean,

intervene I into retina treatment then in eye, very found is start not at disease? wet my question, with is that interesting. all the contralateral as the like you it patients think That's with the atrophy to the way and flow of think how something speak in will I'm say, flow would appreciated fully one eye. even point relates Then the probably Because the in specialist their you to patients, advance this we blind fit into AMD. you geographic of in anti-VEGFs going that basically with intuitively, well, yet time may the retinal specialist, which worst a when

want blindness. start as again, of treat photoreceptor the intuitively the when photoreceptor to losing expect sign to path as cells to can prolong as fully you GA, as makes does At patients you cells, as assuming logically, sense, first possible that I atrophy physicians commitments make they saving as many to possible. to and this it that much Because as will and be, think While not. safe geographic we it early hope drug is as

that drug and that treated product. all patients should be interested find think treated will the will with I being be that market, its I this happen early patients, barring that way believe should exceptions, is into something this in

Ernie Rodriguez

Thank you helpful. very

Operator

of from coming Next line the question [indiscernible].

is line Your open.

Unidentified Analyst

GA, or that good all I our amenable following guess be questions. treatment. could to sort this Thanks for up on Hi, taking I guess One afternoon. patients really on the injection? what that, GA you restrictions you limiting would Would for expect, be any what positive obviously, sort expect? bottlenecks intravitreal data and of bottlenecks of capacity sort approval would there assuming of

Cedric Francois

something the Adam if it safety and optometrist be that more to good practice disease there's is even find ophthalmology in little that and I a may doctor the right available treatment not generalist think the implementations, about of in point well at think time, the physicians. be earlier untreatable. no retinal currently course. angle to office, educate because practical that now referred that the there Adam, in the treatment bit handle give because know Medically, work that patients I available. I'll don't as we've that? be to really but point important of focus and would done will will will on I now and awareness hopefully at to time, be at be point, is think, the main I on that drug this add profile if medical it then then of be will for a to a important It I first should want treatment that a to to It is you or fact talk building

Adam Townsend

injections Yes, of of some experience numbers. doing did years ophthalmologists getting retinal specialists. intravitreal and many just with to increasing question. injecting had add on patient and the capacity We piece of They've the research

on patients discussions in clinics of have believe and expanding approved their have GA So, product new at we new a they'll capability of that current and market know research sites them. which they their the within of based capacity a our there are our no treatments. They with and the addition with currently bolus GA,

drug. limiting expect So, a we as capacity don't launched to be this step rate we

Unidentified Analyst

terms follow-up about Thank thoughts any design the Great, study Can that's endpoints? intermediate you. talk on initial on have of helpful. AMD. Then you potentially in one you pivotal size or

Cedric Francois

atrophy. if region want autofluorescence other of the full you In what AMD retina the AMD we're analysis yet significant intermediate affected in [ph] you again, doing conversion surrogate commenting I about as possible. be. the is with early post I post-hoc treat area course but hand retina. But for the on in earlier actually atrophic still sell notion goes think, image, Yes, call and to what fact your can outside that a the we retina where will as that intermediate in we of wanting The trial patients geographic to hand words, it design and on mentioned hoc discovered that see of AMD not on to Philly, that a of slowdown the of that

patient yet, no particularly that So, and we interested details acceptable. but are design a population

Unidentified Analyst

you much. so Great, much. Thank thanks so

Operator

Next question coming from the Bank line of America. of [ph] Kaseem Hoffman with

is line Your open.

Unidentified Analyst

entering taking would to application be would Hi, this assuming questions. GA can inhibitor talk data? that your differentiated rate your Thanks how And studies, for from What both the that good the approval the commercial maybe calendar us about would landscape, complement positive, view products as those? expect Quickly assuming you year? should on about be be the your able apply well my potential CX positive we the they're as market? Then you the CXQ afternoon. as we for for limiting steps give in

Cedric Francois

going much. to so to then hand will you and I'm Adam the question question. Thank Federico approval take the commercial

Federico Grossi

medical as for We're to teams fully guiding of Thank question. tackle and We're the into the ready for we're as to to to as be primary submission you, of Cedric. as our we possible. have the on the possible. only and the for that submissions not timing results you be looking September endpoints, the but the soon studies jump Thank soon of reporting submit submissions, prepared required analysis will able not are analysis, come in forward the there

Cedric Francois

Thank you for that.

question For on the commercial question, it's data. a

the think, same effect not of conviction being by happens studies is of is properly CX and CX it's end for removed has DNA we mechanisms the the retina the removal We of of that the with which driven because accumulation I It will on competition. suffers as our is the cycle. not on cellular that what CX no on the CX. properly accumulation removed the visual at the by that our day, from being products the which know work those compete mechanism atrophy see retina, geographic

need. So, it hand, we you on be when of kind complement failed well light twice administered successful, CX, as target. too, of in that that can the as surprise intravitreally. the other the fact has the especially There interesting us a you be broad would should to control already, believe systemically of CX both anti-CX inhibitor

covering and pathway. the As you pathway also the pegcetacoplan, alternative do with lectin

competitor to So, evaluating program important pudding hope note I we the [ph] your proof look question. closers, also of I becomes is and to answers think it but is course, that the it's when in forward IVERIX available. only [ph] that that the

Unidentified Analyst

really that's Cedric. helpful, Yes,

differentiated If to theirs, efficacy? you one talk be that program were versus you thing could to would about pivot in your more

Cedric Francois

that their Lampalizumab with In what and done time that words, phase we were to Genentech-Roche terms in our it has Well, think, be have interactions was doing the what trial trial program. a been with expectations We they endpoints knew the time. definitely clinical I was program designed deliberately and in consistent minimum I what tried chose really really at with change. what where about other we X phase X anticipate over like highly mimic XXXX we to to is the had a of the FDA, program

if in carbon OAKS, DERBY quality studied that you the anything, with FILLY a of So, and copy very changes of are and for very, robustness just much OAKS all DERBY more each from other and and have and tiny they pretty trial.

for has wish really they a it's X. criticism part the I planning through them But span So, hypothesis the a and initial key. the of much building different mean, there think kind any part phase IVERIX on been It's went two We program variable. us, without X. I a and approach. the [ph] is was course the one success. and the more phase Then

Unidentified Analyst

Okay, thank you.

Operator

Seedhouse Steve from coming line James. the with of question Next Raymond

Your line is open.

Unidentified Analyst

Hi, this is for Timor [ph] Steve Seedhouse. on

question commercial. have a on quick We

XX a certain inventory trends? have any in terms of is XX you. seen too on fair coming that have you build? to around that Orders to from distributions, US the revenue million or it in geographic Thank you revenue, $X.X early or that is patients mostly for in Given area is assume to therapy geographic Then tell?

Cedric Francois

much. over Thank will I answer. for you it hand to Adam so

Adam Townsend

Thank you very question. much for the

initial to product we're a how But for future. of million going can great the So, sign revenue elevate EMPAVELI not guide foreseeable is the on the $X.X standard-of-care.

of demand. sign should a over over and for had you give we've XX strong sign forms, very which the So, physicians start REMS up XX

the we've come to US. there. second all of more question, success across part On So seen the your

community rem US. So, the seen large from each as main smaller submissions centers PNH and actual geographically of forms from also patients come the would and we've the well across within that dispersed start as expect you centers

across we're impact an So, your question. country. the Hopefully whole having that answers

Unidentified Analyst

on maybe commercialization you. GA Then a thank question preparedness. Yes,

starting terms to early out as idea? where where you you potentially are need to percent still to need are be but you an now, what hire In you're of of you give us salesforce probably do in stages, just versus versus just

Adam Townsend

It's Adam. too. Yes, that one I'll take

the across Australia. carry and certain of office for in created Zurich US, in can we also which infrastructure We've teams for geographic Switzerland, an commercially medical affairs head built obviously pieces in in leadership commercialization and atrophy. and the international have our in we Germany in So,

core the infrastructure. have we So,

rapidly else you as and affairs to everything salesforce we that and expect. see As data, start soon we'll would infrastructure that on medical expand through

the a excited and So forward positive GA the out in who see we're identify do join to join place. Apellis Apellis data are market looking to in to candidates We're good data. and willing we post

Unidentified Analyst

very much. you Thank

Operator

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

open. line Your is

Alethia Young

[ph]? means of Then safety some or what it the the think Just same the that? do and scenarios the Hey, be second How take slightly going? whether think guys. this going your may little front, that out think lay potentially endo-opto it COVID forward, exudative talk versus variant do it Variant, you have how do were you about things events? from impacted infections maybe about scenario, or Thanks a for they how Then of Delta about question every this levels Lambda with you on be whether cavalry Variant, if bit you lower? Can were questions. you in think has having how my taking maybe the is a commercially you

Cedric Francois

Thank much that assume study Alethia. I applies studies. first to you regarding GA question also your COVID to so the correct

Alethia Young

shockingly? How would I clear [ph] my DNA

Cedric Francois

over Adam some us to resources. it will Well, hand to then I give

Adam Townsend

during Thanks, of a product global pandemic. Yes, launching a joys the Yes. Alethia.

in So, we've increase. live interactions actually person seen

live. to than prior XX% were were our they our approval, interactions of lower So,

Now, roughly all live XX% of of in interactions are our person.

use to We with to also technologies virtual physicians. engage continue

HCPs virtual with and great a have we think do success with right we're to going Now, some my of restrictions We're COVID-XX a sure well. and we're slow monitor little having the obviously, bias we closely engagements, we skill Delta could down that regional set the we'll make bit, the but me offices. and launch. that prepared in-person as the But all this their that following those tells variant to

good virtual, the balance in the launch. in between So, person continue a really of progress on to think and we're PNH spot great the we

Cedric Francois

question Alethia, to your you, safety. related related second Adam. Thank to

to by off make trial, safety profile any saying start not have changes X. that that Philly such to the did want the I was in So, we in phase

safety which of of bias fact had we trial, two that with the never to as clinical before. we for exudations exhibitions phase demographic to with cases trial and be a intravitreal the example. enrollment earlier, injections. steroids, the it for of find in XXXX all, the first and phase had in alluded relates as concern. investigator with anti-VEGF the By were trial than X adjusted, on you acceptable found the So, X than types any of That what for that the total in Then rate it done a data correcting X lower the in cases faster endophthalmitis, to to COVID, in will the the very that exudation if be or in exudation have trial, probably phase been well, was the infections the to phase clinical endophthalmitis who line in of trial, hadn't phase as they the be trials X those Philly X X approximately investigators rate phase phase infectious Again, would in rates we expect for were X. it know been relates to

than in have used a a get complication this under you right and normal now it is improves, that no the in There this circumstances. the inherent be then is higher rate would of the procedure Typically, physicians circumstance is that pathogen trial, some gets it X it commercially, So, to is procedure. an what to entry X, itself. absolutely is phase as you see phase that and is better, because indication further rate, that clinical certain

be is So, the background to will safety of profile able focus safe on be will of Philly. and that that expectation the our efficacy we it against pegcetacoplan

Alethia Young

Great, thank you.

Operator

line coming next from Our [ph] question Murph with Elin the of UBS.

open. is line Your

Unidentified Analyst

Hey, so taking question. the for Thanks guys. much

any terms second any know might in we've or in Then in commercial maybe in with exudations or history commercial preparations from seen particular of different versus differences the or around impact strategy question, associations outlook in First, thinking exudations, curious, endpoints natural VA, either you how emphasis And of your [indiscernible]? terms just terms the for what just rate versus we potential was you're diagnosis data the there of the as I any or how about commercial history. GA. historically just anything U.S. in the of VA might natural growth on GA. the asked terms for

Cedric Francois

such to process. But follow-up patients a it's or not. relates undertaking hand atrophy, much. him. these repair don't that kind talking as intriguing in goes you in they clinical be this, Adam the definitely primary materialize hand over GA, exudates phase if find have to those Relates that But go back we what that really in Thank with small I'll a deployments, at whom for look X Then quite hand these a it a in you if hand not to an that slowdown we're wound a observation you talk may the lot something it anecdotal develop is data that's with have healing to trial exudations, hand because at is hypothesis taking measured about on. trial about the numbers exudations endpoint. look to beyond and in we so there's look for the out numbers. and are wonderful But we'll forward of we to. that geographic remarkable Philly XUS which Again,

Adam Townsend

million a Quickly, globally. $X Europe question. about US the GA, obviously in patients million you. $X.X Thanks million and Yes, for in thank in the there's and

that global see opportunity. geographic preparing can you atrophy global totally opportunity and a Apellis, for So, that to we're execute is there against for

built commercial infrastructure have Switzerland, out we experienced medical an in leaders. very Zurich, and affairs So, in

Germany, build our in started have region Australian affiliate. Munich, in already our We based also out to and

and an exciting and we ready ready make are sure to can for physicians opportunity to We that. it's of needs quickly that ex-U.S.; patients very all we doing the be can we're that GA meet GA

the hand to what's part Europe. likely Cedric be the in regulatory on will third was and I of question. your expected side Now, to That

Cedric Francois

so much. Thank you

but a been as in Europe, the would like see of we the European the functional regulatory for. process, the question? the to that in from cells to with in geographic XX-month US, hope the findings gather your points it atrophy with directional like and showing The endpoints that statistically. So not in to growth add endpoint the I the relates loss endpoint, primary feedback we is change in answered measured has alignment through anatomical that we of expectation at our regulators that the that look time the general That as is photoreceptor of Europe. data will

Unidentified Analyst

Yes, you. really helpful. Thank

Operator

Oppenheimer. the from Justin coming Kim question line Next with of

Your line open. is

Justin Kim

Thanks Hi, taking our good questions. afternoon. for

to a regulatory IRR powering [ph] that will CRR you potentially before, at and and OAKS aspects DERBY covered couple a that inform study I with but Just know Oak to on intermediate help had designing study a AMD bit in AMD, just this what how empowering the is as discuss you depending little and point. intermediate pivotal of important design and success, buy-in DERBY to the well. study on can progression

Cedric Francois

to you hear going much, Thank Justin, that Fredric. you. to I'm so great hand to over

Federico Grossi

IRR of the change from the for Justin, are really It's the Thank with and CRR importance important [ph]. we you, the question. regulators on to discussing

next So they're for ongoing And and we'll on know on buying having few so the disease with more an agreement the is the the the look to in the are studies definition important. them; termed endpoint months. we discussions

Justin Kim

label label there into well just study Okay, already informally this plans wondering timeframe one and is publication? print incorporate great. as broad, any EMPAVELI; appreciating And the that scientific for point on any that to the potential the if and quite as data just maybe at are

Cedric Francois

To been it follow on. we'll point, the very yet. up is Thank you and That will so your something label broad has much, decided Justin. not be

Justin Kim

next Great, the thanks to results so much for taking the questions. I'm looking month. forward

Cedric Francois

Thank much. so you

Operator

with question coming Matthew next our Lachine line Markets. And BMO from Capital of the

Your line is now open.

Unidentified Analyst

for everyone. This Nick Matthew. on Thanks, Hi. is [ph]

seems switches majority expect of being is we incremental kind that said as Is you that great. on and would Just patients Ultomiris. PNH that you can like that change to from are And It be of for going any I Thanks. believe going color or one follow-up is overtime? quick XX% us. really said, CX something with going forward pretty well the launch of

Cedric Francois

going to over as Adam I'm much. hand well. to you one Thank that so

Adam Townsend

question, being and the EMPAVELI you're So, yes. are switch seeing correct. majority those from of switches the We're starts, Thanks coming for Ultomiris. XX% of our

said, the they're the CX patients, CX on need. and their is at the of low continually our reminder, one-third beginning the believe being highest quick current They launch, transfused. of and falling XXXX that has a treatments, treated have As and target we a population unmet hemoglobin

patient the that we're that So is seeing. population

as in switches starts continue CX Ultomiris between be be will the of being we progress And CX to the XXXX I Ultomiris move the to there expect Solaris, need then a bolus majority treated patients. we'll likely forward. our so moving the through And balance and with forward. unmet

Unidentified Analyst

Great. Thank much. so you

Operator

Next question Needham. coming Stringer the from line Joseph with of

Your line is open.

Joseph Stringer

everyone, Hi in But our of mix and government, gross on the around Scoping payer terms commercial going just in questions. the commentary a thanks net, future. for on taking to launch. versus it's that's in that the recognize early how giving EMPAVELI the continue you

sense you. You annual know what an sort basis. on of an the gave state that And of you us gross early see on. net a you steady Thank to early in

Cedric Francois

Adam take want this so you to you one? much, Thank

Adam Townsend

Yes, Thanks. absolutely.

the to on this bit in a comment for You're us right, gross it's net too at premature launch. to point

I still And the line into we're the down the and progress to the of to with in with stages window, point, with EMPAVELI tick patients launch. gross but are our disease thrilled to so early in days gross your net expect as transition net progressing other models. we how EMPAVELI, rare to launch launch I'm We latest we as

Joseph Stringer

Great. taking Thanks for our questions.

Operator

of ROTH [ph] with Next from coming line the Capital. with question Alan

open. is line Your

Unidentified Analyst

from Hi, question cost Tim? would line Tim. that ongoing research from an may the separately, in item housekeeping be therapeutics, collaboration be the just The of be

Cedric Francois

research baked because Thank showing it'll a out, upfront this quarter. be you, to be Oliver. impact We the no; broke unlikely R&D on large that that expense has Ultimately, expense. into the that and development is it

pay so will it obligated ultimately, to a demand. a expense year This will the R&D. after we're XX into And is know, be another baked ongoing now. fairly million collaboration research you As be initially, that from

Unidentified Analyst

And days of Adam, get this time Tim. to you from and drug. mentioned component is lead is maybe Adam. the related there. That a XX you, vaccination a to Thank clarification that patients on

are thought previously that You have switch meant patients been patients so most vaccinated. they I COVID of vaccination because these

Adam Townsend

are actually no by get EMPAVELI. Yes, two on of start the it's to before that EMPAVELI weeks label to vaccinations required

not is vaccine COVID guidance. So it's following the label It related.

Unidentified Analyst

Ultomiris, these were because even So previously though have receive they vaccinated, to people vaccine. another they received would

Adam Townsend

of label prior the to weeks the guidelines following first they're two Yep, vaccination on dose EMPAVELI.

Unidentified Analyst

Okay. Thank you so right much now.

Cedric Francois

quarter us call. and last results much. our for progress OAKS conference months and Thank you In second on you look line We you from to presenting ahead. in studies our forward pipeline was our on that think Thank question. the so joining commercial closing in all September, And I updated top the and DERBY keeping

you today and today any the to tomorrow Thank wonderful have Meredith. to free reach joining are additional out around We later rest a week. have you for questions, if again of and and feel us

Operator

Thank and for gentlemen, that you conference Ladies today. your does conclude our participation. for

may You now disconnect.

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