APLS - Earnings call 3 2023 | Apellis Pharmaceuticals, Inc.

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Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Apellis Pharmaceuticals Third Quarter 2023 Earnings Conference Call. At this time, all participants on a listen-only mode. [Operator Instructions]. Please note that today's conference is being recorded. the Vice to Stategic President, hand Meridith speaker Finance. now Senior Kaya, Investor will conference your over host, I Relations and Please go ahead.

Meredith Kaya

will be Apellis' begin, on materially. we Commercial are and Baumal Officer, forward-looking filings statements and Co-Founder me thank These us the Chief based that Dr. Executive Results. point and Caroline for may subject I Cedric and uncertainties, let making Townsend, me that Third Francois, are Tim to SEC Chief Dr. discuss consult for risks risk Officer, our beliefs. additional Chief differ With call morning, out you actual Financial Financial Adam Quarter results Sullivan.Before and the and Good on expectations Chief factors Officer; we detail. current XXXX encourage our Officer, to you to discussed statements are certain joining in Medical

the call over Cedric. Now I'll turn to

Cedric Francois

It us opportunities and and Meredith, we the thank you, I morning. today, have of Apellis without at months period confident where Thank a ups of ever for not and than That with front company its our you joining busy am downs. more the said, here us. share is few this has I'm and in all thrilled in been that

it net quarter . the nearly with of U.S. in third U.S. the code underscores generated are October estimated begin with fall, net presented first believe weeks we XXX,XXX resulted launch vials our the of X, effects than The of a stronger resulting vision last treatments.I'll in retinal million date U.S. $XXX of function $XX in total The demand of We less with through lives since in the are ever permanent from launch. we key events demonstrating product with continuing on vasculitis and to important loss have impact and third in became be across months delivering our severe X.XX%. of revenue in generated of rare X.XX%. these highlights having quarter, some about of GA more at potentially efficacy rate reported million U.S. since long-term visual been than SYFOVRE's SYFOVRE benefits and to effective even than really increasing driving a in patients our in finally, time, on in pipeline Importantly, cases that on substantially largest product new to product our is rate quarter-over-quarter, is to EMPAVELI thousands $XXX SYFOVRE the of And the outcomes goals have the continues which J additional emerging X, data SYFOVRE continues distributed more positive to bringing SYFOVRE show extension few GALE analyses in A up October. been SYFOVRE the update SYFOVRE transformative this the seminal feature include million net over on revenue develop irreversible profile X XX% of patients. Visual study October and revenue patients

at case fall the quarter GA reinforces but a privilege continued for year-to-date. X,XXX community we with have European have of on not for with their to Retina Euretina of decision to treatment the years over cases.The do the retina continue that have of the was the of need emerging XX% what Euretina, infection. doing events spending track for decisions hard time will can amount product provide MAA the finally been with July.Globally, and their continued After EMPAVELI, challenging third vasculitis U.S. a Agency, patients. in the this possibility was estimated I I growth investigation. specialists rates, back doing to impressed forward team At we our hear for product to are plan having in our we of physicians at provided In launch. of net and patient transparency about enthusiasm unmet on we $XX prepare on compliance demand faced single rate longer patients. revenue XXXX. right the for the and to for GA had few corner the unexpected Medicines lot both European still in has We and Given million now sharing early need SYFOVRE of $XX opinion to believe stability challenges incredible success the of the they learnings work the months, the information this treatment and the strength we leaders the the turned have were to from individual is so, to rare events, meningococcal also retina now discuss looking patients.Turning to trajectory of profile. product EMPAVELI. are we shifting through submission Society. generated There with which no a With the summer, the with rates a to million this from discussions we European our build some worked but of we the and back was trust our in encouraging our It key make We and

is injector. approval, from believe announced the will of EMPAVELI number restructuring. the for are prioritizing have which top unprecedented PNH the of for expand kidney, experience patients at Nephrology. that comment speed to high-tech a corporate diseases. line we NOBLE the organization, One in enhancing our III data was like effect line who II offering continued systemic positioning by the study I Pegcetacoplan simplifying approval Adam, is IC-MPGN driven during mobility commitment rate these Phase further Society With IC-MPGMN an of SYFOVRE patient's Saturday its of quarter recent streamline company for this We long-term these all colleagues. the than also our our significantly and administration.We in and the and affect opportunity contributions on We more third injector, and it CXG, our Pegcetacoplan are success. took strength the FDA actions results Valeant CXG top from EMPAVELI the study magnitude expected the by was which had population. the receiving growth with we in for and grateful and of EMPAVELI the quarter American key we late kind innovative to are an in The of be data this of Pegcetacoplan highlights of from volume In the and presented that benefiting to we to the of This over to look I Phase decision, treated forward difficult Xx as our August, XXXX.Before of turn first would

of elements initiatives certain includes As retina a runway the of GA, on reprioritization in second CNS to business, restructuring. improving at up of finally, operational later, our efficiencies. key leadership result streamlining CXG, $XXX as extend of focused in least this to PNH Beam And EMPAVELI will SYFOVRE's XXXX as research our and global and now into total Tim savings to reminder, collaboration quarter we and with a the anticipate cost cash million IC-MPGN continuing prioritizing the XXXX. through speak maximizing and in our development We expect commercialization

will our As a discuss on our mission commercial turn to now for are in to and future. create shareholders I and our to now for believe deliver more value organization, the in focused activities. we we position over a Adam that, it stronger With patients

Adam Townsend

Starting It third quarter, vials SYFOVRE. In and U.S. product and we quarter strong a physician in samples generating for Thank you, both $XX delivered XX,XXX Cedric. the net SYFOVRE revenue. XX,XXX was to commercially million practices, with EMPAVELI. commercial

effects growth by the long-term and encouraged and this to was QX the will efficient significant is study.On of demand goal our J-code growth X, We better particular, August. important In by of effective, the billing are to having ensure simplifying SYFOVRE profile building this the October reimbursement in that our performance. including of SYFOVRE, a data, seen driven a bringing believe permanent and all understanding in quarter-over-quarter GA safety became This treatment process. of on of treatment GALE need. patients milestone physicians SYFOVRE the help weekly and this return extension beginning increasing the real-world to in reimbursement We patients compared

now than where a payer of demand addition we commercial execution, of than permanent SYFOVRE, with growing. and As payers covering were Medicare the and of more in J-code, higher our July is excellent the XX% coverage result

since number of launch. care of coming from both new care to SYFOVRE existing every ordering week see a orders continue with sites sites new double-digit We weekly of and

Additionally, reinforcing by with building the strategy flexibility to remain every patients, engaging is weeks, payers. how our important going majority laser-focused we retina commercial to SYFOVRE are population.Our X physicians this depth seeing current specialists. of stakeholders, retention to for momentum and We on plan is among patients vast forward breadth, dosing leverage X physicians and key this patient treating

We to patients are also globally. preparing to bring SYFOVRE

Institute living Kingdom. with recently can simultaneously other to are initially treatment more plan where dossier submitted Europe We we million to United the no as significant opportunity the in out Germany, people immediately, approval, National Care work in are we our in We NICE, thoughtfully a building launch or for Health Excellence, and for obtain and us sell countries. infrastructure the for to commercial there subject than X.X European represents product EU GA to available. while reimbursement and reimbursement

U.K. We XXXX. first in expect the Canada, a as half Australia decision authorities as by Switzerland regulatory in well local the and of the

positive rates than we on top for high Turning strong this continued CX the patients quarter, indicators from XX% payers. to population, access continue among key third compliance remaining patient at of In XX% over including inhibitor the XX across patient trends coming switches and more leading ULTOMIRIS launch. see Patient the since therapy, to XXX EMPAVELI.

been from This third product to for more coming U.S. strong We of PNH is driven the progress and more resulted which to the are forward The the coming teams and has print field working and are growth excited inclusion about patients by experience and injector. look positive, on to injector. we is in EMPAVELI. the in treatment-naive we the label efficacy months. existing Initial with patients approval continued market more the Cedric the also safety, of in bringing quarter. a now $XX EMPAVELI transition to seeing population these feedback given data injector reflected continued the the over net revenue in both results.As mentioned, the million are

also from experience. reinforcing new patients benefit safety focused on are We long-term this and EMPAVELI may treatment the real-world data and and who bringing to efficacy

over the turn call will Caroline. I to Now

Caroline Baumal

morning, Thanks, Adam, and good everyone.

Meeting, its Annual solid We Euretina months and of Retina at ASRS these reactions few medical are especially support in have past the had including a meetings, significant we several continued performance The weeks SYFOVRE these community, meeting. and feedback hearing presence and multiple the growth. from the medical the last Society

As data.In effect the Slide the therapy reported of XX months previously our long-term presented more nonsevolia of and at shown date. increasing GA in an on GALE, SYFOVRE projected any lesion by lesions, pronounced we sham deepening a compared SYFOVRE to demonstrate to study, continue treatment clinical time growth to month monthly with effect for the the every understanding with first with data events X, GALE arm GA profile out to and extension consistent These both with shown results of our the efficacy SYFOVRE. patients other XX-month greatest reduced ASRS, with even safety

from to functional function extended showed a benefit. long-term In in sensitivity supporting recently data data showing data adjusted Phase updated we presented SYFOVRE. which Retina third critical analysis, light extension the efficacy this Society also that presented the for Additionally, visual prolonging of GALE We OAK profile the build post-hoc at of visual study. full analysis functional III an is SYFOVRE analysis the visual function.We on study, continue covariate our acuity microperimetry our

patients X we time with acuity treatment continuous to to favorable in years on share we this and add GALE. presenting arms over ARVO, to sham GALE XX-month in American we crossed Both as study, forward to treatment then visual extension pegcetacoplan.We Ophthalmology on the active SYFOVRE's As saw the analysis of of over will to trends patients long-term best see for years. further our At corrected this looking at are demonstrating and out weekend increased in Francisco. SYFOVRE XX-month efficacy safety of continue the upcoming Academy overall these meeting to the a consistent in data meeting, data who compared San X at from profile a efficacy effects profile

X data the new X,XXX debilitating of presenting II and CXG of also NOBLE slide were patient. CXC post-transplant a no are we that just IC-MPGN of are the up that for to press orders in particularly release IC-MPGN kidney XX an which affect disease and the from are a one by the and treatment is weekend translantic or staining the reduction X, treated this treatment showed Slide of to kidneys reduction approved these image at how recent intensity is in In staining on primary and magnitude on of striking XX% indicating in effect in seen As for endpoint CXG. of with deposits is recurrence this of baseline. order X by showed that X shared available. potential estimated as weeks, have study investigating treatments staining Week United more of showed Phase data XX% study, in X,XXX pegcetacoplan in States people Kidney the recurrence. CXC XX% diseases What in at least magnitude, pegcetacoplan cleared.The rare Europe patients a with quickly pegcetacoplan example from was CXC showed our intensity,

up. CXC has the This see clearing with left baseline of never lit the can it's the staining on gone. At activity magnitude image the been immunofluorescence second green in bright can see disease that before. kidney You you or the in week shown or CXC XX, at areas

stable key with including across treatment measures, kidney pegcetacoplin Additionally, function. proteinuria improvements showed clinical and

our enthusiastic cause Valeant tesetacoplin and study, of by of of Investigators adolescent rare native strengthening both serious expected disease, potential is patients. the enrollment and diseases.We CXG. adult these in small of results been confidence a pegcetacoplan our patients forms native for in in new evaluating the in We about third with pegcetacoplan the completing study as study was targeting in a patients the have data this this underlying Phase currently that indicate XXXX. While are treatment bringing post-transplant IC-MPGN III and with line these and recurrence this and year anticipate in quarter top end enrolling post-transplant

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

Timothy Sullivan

Caroline. consisted collaboration U.S. $XXX million of revenue, third EMPAVELI quarter which revenue from you, million for the revenue in product was product million, $XX $XX Total US net net in revenue SYFOVRE Thank million $XX in Sobi. and

the as to in the product recognized the to is as by distributor distributor. therefore, distributor product and any well as revenue reminder, the physician shipped a As shipments includes inventory at

be X We based estimate expect distributor levels continue to and of approximately X demand. the on to to weeks inventory going forward on hand inventory anticipated at consistent these

of rest R&D million. point to reported expenses items and will were the net $XXX were loss in financial to help expenses our Turning and in G&A $XX that we a million of the $XXX like out a business. million, our statements few I'd evaluating P&L.

combined higher pen price than approximately variances totaling goods million payments of purchase third quarter, milestone periods due to cost to First, sold was million. the in and for $XX.X previous $X.X

previous terms distributors. recorded and associated $XXX.X line receivable as has is to with with million, provide those terms. that sales and The primarily accounts line Sipo of is than is we also payment higher in the which payment accounts quarters have increased Sipo receivable we Second, increased item

to necessary G&A Third, from $XX This current now in medical for a certain instead reclassifications periods. approximately of million affairs we other an quarter. costs R&D are of R&D. No in represents categorizing in shift G&A and the were majority prior

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

to beginning expect in XXXX. these efficiencies realize We

cash in better to us call we now XX, savings balance the and quarter this, our cash turn XXXX. operations we October from remarks. provided and at a now I recent September of and back trajectory to restructuring, into on the least equivalents. fund with demand September based will over $XXX had and our closing Cedric? expect million second sales view demand And XXXX, cash for the of Cedric going of our As forward. cost

Cedric Francois

Tim. Thanks,

the are now rebound and quarter clear was progress this not year. in we a seeing accomplished we earlier but challenges, without This growth

of on with priorities in our market markets shareholder long-term on the the alongside creating are to strategic SYFOVRE's in cusp EMPAVELI. delivering expanding reach PNH global We remain We growth value. and dedicated steady

for Operator? now us questions. open the call Let

Operator

[Operator our Instructions]And first coming the of question line Evercore. from Kumar with

John Miller

the the This in And is you doses maybe between Can on a has What impact identify Maybe that really Or at rates? now proportion places an update any experience some estimation? out ahead signs of then of vasculitis. this that of Miller the any on are that speculates there Do of point? our motion through in sitting on. shipped there that profile have assumptions had any suggestions on all are fridges early your the might doses switch risk and of stuff. John you've etiology more needle vials at patient front? commercial you difference secondly, of Or making various Is maybe been given? in patients time?

Cedric Francois

to to great first to Adam, then and you. the question hear have the over I'm I'll second John, one. take going

Adam Townsend

give execution. things with so numbers. extremely we're John, confident I pleased first think let the a first, commercial you And few me and

the XX,XXX obviously, about samples. third quarter XX,XXX vials commercial So at in

an All average refrigerator. to vials of vials of physicians. sitting to X.X we of shipped were based assume, our a these about And on math, in demand weeks X

being So have SYFOVRE. launch, XXX,XXX think with over we since treated injections XX,XXX patients we about

execution. I think it's strong a really commercial

second back question. answers that to the your hand hopefully, I'll And So Cedric part. for

Cedric Francois

whether over and understand the an couple of of of still about very Then provides or track. need Adam. you, to or the the too here so But able been is rate metric it mean, early, I confidence to the we're needle that months, right, course, another to it low not. something vasculitis probably past the we've going is right? stable, physicians. to really important impact most etiology, is that talking X Thank quarter had And

loss. with of So you're continues severe basis. at using course, than significant of rates are also world, in we be have rate real more metric meaningfully it's, patients the X.XX% a there, XX,XXX important than But of rate a into at and injections that per XXX,XXX and to to a rate treated, vision X.XX%. patients on are at done still a injection look the And also lower which with X.XX%. And

something but and being the to understand time. So over stable followed we future, most hope of better importantly, course, in that,

Operator

And the of America. our Tazeen next Ahmad question coming of with from Bank line

Tazeen Ahmed

Just wanted about competitive I to looks if And reported March. year, could. $XX calendar how ask like their Astellas evolving. for $X they which are it's you market, about first month landscape, projecting the has a million ends for its question the and It full on believe million you I think in

about So feedback where, getting increasing what might whether can competition, anywhere, just you seeing patients be force from it's about you talk Thank switching. field and you're if you.

Cedric Francois

Great Thank to you, Adam question. you hear will that Tazeen. take

Adam Townsend

Tazeen. Thanks, Yes.

very the first quarters, noise line which interesting. the with investors, that's sentiment and year not firstly launch. first to are hear from $XXX in X of back we I And hearing given field. that been lot million of where We We're us physicians, field. think surveys we're Izervay. reporting, hear if relatively the X the the with field. quiet quarters hearing is what is on bullish we analysts you different their to a in fiscal in lot at of much it's So really, It's done our look from not It's in a these really where physicians were

hugely So launch. that's a successful

our talk physicians on I vast to strong are of to long-term just which every over using And be is X effects the X majority efficacy, going the flexibility. to laser-focused about dosing increasing clinical SYFOVRE continue are say, profile, to think weeks. we executing to time, plan,

continue strong with payer positive coverage, to will growth We very I'm October. J-code in have our SYFOVRE. that confident we show

We be execute our So plan. we're our going on plan. to focused

incredibly think well. we'll do I

Tazeen Ahmed

relates date, follow-up, they telling for every to a weekend. maybe as a other want XX-month what at week, you about on it And separation be believe, to curve I to as month other And this conference AAO what is physicians Okay. month, Astellas every are going the dosing. showing see this

Cedric Francois

Thank you, to answer that? Tazeen. like Caroline, would you

Caroline Baumal

to like over increasing you. Physicians effects Thank time. would see

extension very Academy the will I for of have important study X received the this at pegcetacoplan that's patients think we of the some be patients where data, of Ophthalmology have And presenting years therapy. weekend, -- first American GALE our of them. received year the continuous

they study be years patient GALE the also the and I first of month monthly dosing think by X and And of the X physicians this being actually, pegcetacoplan out treatment. science are with That's will like be behind flexibility every be that's impressed will other by data. patients in clinical with data, years and will impressed dosing They meaningful pegcetacoplan. the -- continuous December. rolling with our

proud really data. we're So that of

Operator

And line Rama our Anupam question coming from with JPMorgan. the next of

Anupam Rama

those of is SYFOVRE, summer, X/X the So that sidelines you maybe on And in What comes that what information. the for waiting from terms back you're previously you of it use X/X, X/X to or seeing in utilization. was physician more bucket in X/X, this were when that breakdown breakdown talked about that are now?

Cedric Francois

Adam? Thank you, Anupam.

Adam Townsend

Yes. Thanks, Anupam.

QX that market So results our research to last similar the showed research obviously, that call. shared update on the the was in we And August. as to

being and SYFOVRE little that is signed our see growth Now driving open, continued the week, think That launch, seeing you're for new continued of and it's have I SYFOVRE, And I think bit to them. And We that see sentiment We're since to for been really I sharing from physicians for new us metric transparent. new we of numbers a the absolutely with start we're love. SYFOVRE encouraged I time of that's for every accounts being enthusiasm you double-digit physicians powerful the had shows continued started it's we're metric think We're since results. super one from launch. patients. start physicians. a first

we've bit honestly, conservative. seen seen have more physicians -- some a totally We become

done, grounds the that -- and from they bilateral seeing more you're We also, doing eye it. are they're making interactions. are still see as market results being now but the bit choosing physicians example, in their bilateral injections For research, injections of approach use thoughtful they're the SYFOVRE. that a the first starting being number how demand. we're really, do not first think worst many And really segments I think each the third in in of one to those patients driving in I segments, of But we're

Operator

And question Kusy from of Baird. the our next coming Colleen line with

Cedric Francois

I Colleen, don't can you. we think hear

Operator

will onto I the question. go next

question coming Nochomivitz next line with Yigal of from Our the Citi Group

Yigal Nochomovitz

I had one on IC-MPGN and CXG.

So standing for would expect you CXG in the a IC-MPGN be or about the trial to And regards what that more before showed you the patient patient? 'XX line? each And that proteinuria -- will any pegcetacoplan then interim in there considered an of you similarly slide, was indication? broadly, then Valeant, XQ clinically could would that as reduction be level top of analysis And meaningful? talk behave

Cedric Francois

much, Thank question. for and you so Yigal, that thank you

histopath I cannot attached that a from. for And CX So image the as this. saw cells in that how the glomerulus. patient not and those reminder right? a irreversibly so So overemphasize you are meaningful CXG covalently, In to IC-MPGN, with was that that get of you is, a deposition that familiar CXG just

to to that For away, can you cells have and CX deposits healthy product that go it process actually need properly. those internalize

X over unbelievable. the improvements in months course to us for of is is And see really this So the post-transplant actually these situation.

a disease. of had recurrence are the patients transplanted and these So actually were that that

these say, important And CXG the really IC-MPGN. this We both again, this So population. post-transplant in well meaningful in and see in to to very effects as as really, segment setting. needless mentioned,

not proteinuria readout, be in clinically consider As will reduction it to going there's an readout. interim and to we relates a to Valeant, X-month XX% meaningful. There's be

Operator

coming Raymond James. with from And our question Steve of line next Sites the

Steve Sites

I had questions on X SYFOVRE.

sales less First at is to And I USD you billion the visual noted? function amendment think look a SYFOVRE. or that also And peak many if the that similar currently well, some to a have and how discontinuations GALE about sense Curious Second retinavasculitis curious update? RV of patients had SYFOVRE? can able so, on would treated I'm be XX,XXX as are expect how data or therefore, might to provided add you label that include Or just lastly, billion. if some if of that you're for disclosures, modeling if just you you more mentioned, actually back estimate USD or to that is you you patients X.X know would X.X question Astellas treatment bring on guidance amid data basically, some the you point? then many

Cedric Francois

and Thank Steve. much, so X you the hand the take I Adam. over first will question other to then

be think there As change to relates the we so point. I should label, update that it expect label will a and some at

think is label before we it's with again is happened, a situation have get we noteworthy change. with fact to rare which the a it tracking stable I hasn't that a event us that think very a of reflection that I along the FDA,

to as can what it be of relates followed far that, it we don't know take course, will as you the next Adam, something be thing? that's So to yet.

Adam Townsend

Steve. Thanks, Yes.

to worldwide, of but me question, So answering a all now of during again, way the believe, with we X the try look question. are to we -- then patients it, don't patients July we best are It's of And guide, your expect stay incredibly part third sizable is market. very we levels, obviously, we the we think, think GA I we're discons, discontinuations from is is demand probably that trajectory. think vasculitis but all starting back think new of and the think growth retinal see very so are you launch. patients metric at treatment obviously to I especially on this low now and the short start motivated. answer was discontinuations think And did phase, period, to time to patients this as on in in We currently -- I very that XX,XXX back see and low if trajectory early benefit quite patients the October, But because it's low a we SYFOVRE, the during moment. it's some continued the million

Steve Sites

Adam, clarify. to just

it. missed I think So I

the So XX,XXX typoreestimate? current is patients on

Adam Townsend

Correct.

Operator

coming Nadu Our with Colin. Phil next TD question from

Phil Nadu

like the on vasculitis presentation of Do a this to to expect at be to or make Is expect that going when their is you significant weekend? meeting there meetings rate or on evaluation guide the expect question to once a And updated ASRS then medical cadence of any at you a vasculitis. a number like Do willing you'd updates? A this future we weekend? cases quarter something present or could rate just forward, of that? AAO

Cedric Francois

you, Thank Phil.

here is I and what's remained that rate unchanged. under So control important really think this has is constant, is

is that something. really think I

talking in cases is that's So a To on because, but an that with we're September patient vasculitis to So individual not atrophy from been last X, with us that going the perspective, fruitful. to that right? non-GA frankly, reported of geographic we about case had a already with is case we think it. September stop this put patient was that's effort XX,

again, all we this. keep So tracking of

speak We very relates changes, to can will them. because case-by-case on on are closely Caroline report Then we've do been but are as basis. briefly if we with to collaborating it there a ASRS, this this not to going this

Caroline Baumal

Thank you, Cedric.

Retina photoreceptor Society preservation as imaging intelligence having the American be weekend the meaningful as and presentation some very aware, data and microperimetry the a We an no as at be far Risk on data, cases. But provide with we the our update are ASRS GALE in the are from at Academy. be there this we in as close Committee and at did regards update study. well And to will communication Academy presenting artificial with to addition we'll

Phil Nadu

when we an should forward, on quarter going once sense a or the expect of updates? you'll any like rate update provide And

Caroline Baumal

per FDA remain receive we is if the that regulations. community. with rate to And to continue we transparent that reported physicians the and update everything changes, will as Well, we

Operator

Fargo. is with Wells question next from Derek Our Archila

Derek Archila

the guess the one your Maybe do how just on interactions in for EU adoption bid application? Europe. EMA recent And with opportunity, different be you I maybe overall have the the of any the think will the just in is than U.S.? market terms this Adam, on

Cedric Francois

much, Thank you so Derek.

So continued and to on EMEA has track. track is on be

of being years over labor physician as in love couple of a mentioned the the as many really been preparing we've well a this in -- As has regulators the So as do times has as And of want community adoption. past, product, many, to about briefly Europe. very next about believe, maybe talk offer this the you payers right? we're year, to we excited well able the Adam,

Adam Townsend

for Yes. Thanks question. Derek. Thanks, Yes. the

in are affairs infrastructure. terms commercial and medical ready to go We of

we're X in get to So right? ready go Germany, obviously X in to Derek, are feedback. X.X about good we So million GA once worldwide, U.S. patients the we million

ex So the U.S. all rest is

I to for in a A leaders were think nice all being ex opinion they the little this as few doctors quickly. U.S. drugs transparent assessment it's a U.S., the we the XX% discount it's is And teams U.S. technology as approval, market prices and invested Obviously, XX% payer know a key about anti-VEGF sizable leaders. the XX% about highly they a anti-VEGF the are ready -- market Even it's and that of very opportunity opportunity. with things a metric, that And sizable of been key will example, doctors of the really health get We should likely think a to to that think we for sizable about. ex we've believe information to to time So are we analog, be get branded opportunity. again, So right? us. need. to that with go and that And very U.S., anti-VEGF sales prices. the have opinion

Operator

moment One our question. you. Thank for next

from UBS. Our with the line of next Eli question Merle coming

Eliana Merle

how perspective. bit a little on feedback confidence we terms expect is talk got next physicians of Just latest what there? going then some another in the contribution review And the Europe. approval your to you've and U.S., should to just any on the in and terms you the on and then commentary Can in revenues year on And of Europe their Europe. on safety the maybe relative from about

Cedric Francois

revenue. you, again, Okay. the well. have Well, Caroline talk speak then European I'll discussions the have first safety will Thank Europe about or about on But one, can then Eli. Adam Tim take I in doctors can very gone and

Europe. we in As comes Europe? over important know, now that functionality something is good And of with as GALE, very the on Caroline, all kind feel the about. of that data kind correlation very you in doctors is together also to time,

Caroline Baumal

them well and microperimetry are connected product clinical of confidence the the are this with and data-driven, a function really global were have involved Europe in Many KOLs use. community. The in have familiar It's U.S. our with high Also, KOLs. visual and in very its really they're study we data.

We have impressed but key in looking SYFOVRE. leaders the also by this of and are to forward U.S., in Europe microperimetry on are data use who

Timothy Sullivan

proportion large terms then ex And Eli. U.S. very potential is revenues. of a in of future revenue, Thanks,

revenue. anti-VEGF, with we less of that's XX% more per around that -- patient. revenue we patients So the estimate It's actually total but expect

In terms we first that of one while of becomes a expect however, approval really quarter, Germany. being next basis, first country-type the the in by-country rollout sort year,

year, which amount we next right in but don't will first quarter. we revenue do of approval, contribution be to we expect recognize we able the So a huge after expect expect

Operator

Thank you.

And with of Akash next coming Jeffries. Next from line our question. question Tewari the

Akash Tewari

This is Kash. on for Avi

X have We questions.

laid X.X but this, X $X.X billion peak around receivables, estimate prepared to you remarks U.S. proxy, I the competitors Could to is in this of asked million compared peak level quarter What's distributor's And someone which there? the like CNY just inventory quite think at to First, of at which is, think today, year-end. level? sales billion, in current visibility maybe conservative their which CNY announced numbers seems give million as the on billion the implies you account said in the compared I out at us their $X second XX more also already around

all? think with you view may changes your geo saprogram at changed potential? on has do what have And curious in So market the

Cedric Francois

I Thank over Tim for and it will Adam. so to question. that much hand then you

Timothy Sullivan

we fact accounts typical big terms. but change The to that Sure. relates also the have extended market in fairly payment receivables

is for we particular, expect SYFOVRE. don't distributors. issues this So is largest of collections. that receivable and portion the terms the in for in any In primarily launch a typical space, It's

remarks you'll with time sales I Astellas, increase. fairly that they've that gigantic respect just why increase then what number And they're had what is still change. think they evaluating it's launch, they're their this number we as slightly think us. I mean, their obviously and you it's saw, in market. based seeing We to will And anything typical. And see said what think over at they're prepared from they So I speculate -- you seeing that they're that And I do a expect hard for see on to us not looked if personally, time. also only but from early evolve over

Adam Townsend

but a we it's believe -- driven which by large just Yes, also product market Tim's it's to of Avi is truly a market, to Yes. aspects And good add it's a Adam. certain profile.

So effects over flexible time. increasing dosing,

It's competitive to So we a opportunity worldwide. within patients an prevent time over vision truly have a product. and large exciting market, believe help we very

we're that. to get excited after So go and

Operator

the And coming question Samimy from Stifel. our Annabel with next of line

Annabel Samimy

a had couple. I

fruit and use less bit initially. now becoming events? moving with a I those are low-hanging patients. selective guess their with physicians experience of and physicians greater to the this since use know patients? having little notice level more Have understanding So and their increasing you they in the that that rare event, selecting are more had the in identified I a our are change more comfort maybe become way severe Or do you liberal is some

physicians type there's secondly, moment And any bit So have. of around selection patient where comfortable the was be if guidance color giving then just a SYFOVREsales little you'd on wondering forward? of I going

Cedric Francois

much, so you Annabel. Thank

Caroline Baumal

Thank you.

from present enthusiastic in the drives they first, drop science you visit data to they anything physicians comfortable eye findings, than them. example, they thicker, understand, which their conservative be with with that really and not very for have intravitreal beginning, have what the continued treating both may with slightly use the which injections, are have we they is seen now we very the of I add they the do product, Adam, What about and about set eyes but the of worse we large that's enthusiasm. more first the starting understand technique physicians and robust are SYFOVRE, is uncommon think or is clinical little to and were not whenever a have that that?

Adam Townsend

Yes. for Annabel. Thanks question, the

positive, for start I SYFOVRE in-roads launch, bit And give every and graph that trajectory positive community. me. it seeing that and demand in J-code, confidence new Caroline's confidence. accounts drive is people continue little of the -- us comments, order and expect week patients to time. the eclipse think is love really this come July terms now you of presentation Just about the earlier. this a since me solid said, use and I that. right? first in that think And to that's we're the double-digit I as to a to very I October, And pause I SYFOVRE seeing thing. every Caroline a coming It's it we've signal excites had metric in to with -- the think on we're to But I'll I was is how levels, week. again back new we're the drug, because gave a starting And add thing one to of back make to it right? the saw into

Timothy Sullivan

jump And I if guidance. that where were just next X ago where know haven't me we give but get we months know our we'll guidance. say let something couple plan is I don't today, we where excited. guidance. feet, have to, in really decision to actually of don't committed on quarters any really are. can ask we What we we'll good I'm you'd of you are I I know a I'll And the when we Sure. It's on when under that. more we'll when the have a sense will and think we give

Operator

Our next question Douglas with Instructions] Wenright. Tsao coming [Operator HB from

Douglas Tsao

it about any treatment you for I'm resistance and physician of -- of face or to reasons, fully they're brakes number like to aren't they trying patient you about sort with more treated, to to commented, redirect get wanted be are on how want just that And say that? hesitation overcome readily is that to matter sometimes I it get right? on their talked patients time trying to it who how of to are trying just doctors, the you of ease terms in Adam, start patient something to the sort of to enthusiasm, to touch treating the on SYFORVE. before talking up and a say doctors convinced perhaps and necessarily guess, patients? pump to docs interest sort on curious, of get of I of demand. are patients they in an don't I to efficacy Or Because trying safety speak to stocks sort seems some we've

Adam Townsend

the question. for Doug, Thanks, Yes.

with GA So my vision changed our They This and those to we activities. we time launch. TV to about anecdotes type spent an to prelaunch give able and have with That read time spend Henry them see did all used We're doing to that SYFORVE, were should our they want they activities with has commercial a yes, and not grandkids some they I treatment. through and a very obviously of patients go ophthalmologist impairment be help of an may and or since is and like retina patient interestingly, Winkler. driven lot enthusiastic us physician population. patients, of to potential optometrist radio campaign a -- super of or flag

an has impact impact a benefit We've prescribing physician. positive can patients market. started that has to the risk into motivation physicians. physicians that That very now also see discussion a the driven had I and have in these with think that's on patients, patient

we'll activities patients. to to drive more do So continue

reason, physicians patients some if that seek for injecting that other found will physicians that these are, not have We are. whatever

the this and it an highly within motivated good market. physician So highly, that's highly incredibly happening of But is meets a patient discussion conversation. population motivated

Douglas Tsao

whatever the of that just research curious focus market third -- I I'm never there's been going for to those talked one were sense of third who And from do be had just dispositions of using were sort think or users. follow-up. ask of third, you to them or had summer. Great. your lot weren't third, I some doctors about sort of the just the a reason, can using many big if how stopped of were on you know

sort a really of good hitting And of of now you're of market. of sort truly sort so right the part receptive sort that

Adam Townsend

Thanks, Yes. Doug.

J-code. had to we said, "I'm launch, again, So pre-SYFORVE going who to drug back if jump always until use your physicians permanent a I the not segment of

assumption the third your segment basically X/X going X/X those physicians So use J-code. in that to also said, included waiting for an there who drug was not that, our we're were has

we potentially segment see that segment within last have will an think and I impact the seen an impact that quarter. in within So

but I message also think more open can transparent pushing we the can we our be, efficacy more we're now be, physicians. the with

think strong to demand moving those forward. see segments. And -- quarter I unlocked segments the started with of it and for unlocks had all we that those levels we've this since

to a next be think I of very it's So going positive couple quarters.

Douglas Tsao

Congrats on the progress.

Adam Townsend

Thank you.

Operator

Neha. from Our line Joseph coming with Stringer question of next the

Joseph Stringer

of want to up start get they total injections is see following patients matter it Or injections is injecting? sticking or a injecting? are a would a for need if SYFORVE the the to they physicians comfortable who case And is to number Just for higher of X or would a there the that the it's currently more point? the total see vasculitis lot on of rate more with injecting Is are more safety physicians that before and threshold number last questions of comfortable rate the not patients is sense before of number the reasons. your they that

Cedric Francois

Yes.

started an never mean the worse there drug question. you rate this rate absolutely this issue, think, there years so against drug. It's is is problem was the here. a to sensitization I that This I that orders was in bear thank magnitude for up a because of couple rate the was that with important that ago, case was much Joey ended -- in a mind not of had that and we the with itself right? another

but an commercial the keep Adam over to briefly can time. between we're this it very the I So And impact that. now extremely and going is as straightforward maybe conversation event on that, rare mentioned, patient. a comment the of sporadically physician tracking is

Adam Townsend

Joey. Thanks, Yes.

those They Every has vasculitis subset technical as physician Those deem launches. right? for a if takeout a population matter the in physicians subset before would conversation We've it's So see had right? X term population I "I that has happens drug get laggards, that follow space another with using follow launch it for wait unlock a start." launch, they a same doesn't the exists. wait retina the It of to good or to "I within second. So launching leaders, of and physician what would Dr. we this drug once launching in through Professor expect said is who you're want who J-code." that no experience. It's I a So as drug launch the said, the surprise, opinion all they see to for the that -- key segments. that physicians or trajectory, we of Y we permanent experience had

get to need will I've the My that As enough. are they now. the to those physicians colleagues say start waiting in use I understand check who seen box this it. to using, I'm are going

a it's future So opportunity.

I think we'll continue to make inroads within segment. that

Operator

at the And I back time. the Francois closing any I now Cedric this see no to further questions call remarks. over turn for in Q&A will queue Dr.

Cedric Francois

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

around are We today later and tomorrow.

out Thank have you to day. questions, a any reach free and you wonderful additional to have again, Meredith. feel If

Operator

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

You disconnect. may now

Apellis Pharmaceuticals (APLS) 1 Nov 232023 Q3 Earnings call transcript