Apellis Pharmaceuticals (APLS) 28 Feb 252024 Q4 Earnings call transcript

Company Profile

Participants

Meredith Kaya	executive
Cedric Francois	executive
David Acheson	executive
Caroline Baumal	executive
Timothy Sullivan	executive
Jonathan Miller	analyst
Tazeen Ahmad	analyst
Salveen Richter	analyst
Yigal Nochomovitz	analyst
Colleen Hanley	analyst
Philip Nadeau	analyst
Katherine Wang	analyst
Eliana Merle	analyst
Annabel Samimy	analyst
Douglas Tsao	analyst
Joseph Stringer	analyst
Lachlan Hanbury-Brown	analyst
Ryan Deschner	analyst
Derek Archila	analyst

Call transcript

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Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Apellis Pharmaceuticals Fourth Quarter and Full Year 2024 Earnings Conference Call. [Operator Instructions]. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions]. today's being that advised be conference recorded. is Please turn over Investor to would and now Kaya, call to like President, I Meredith the Senior Finance. Strategic Relations Vice Please go ahead.

Meredith Kaya

Chief the you Financial President XXXX With of Officer, Executive Chief Executive me Financial are Acheson; us and Officer, Full call Results. for Medical the Commercial, Caroline and morning, Quarter and David thank to Good Baumal; Sullivan. Officer, Vice discuss Co-Founder Apellis on Dr. Fourth Year Francois; and joining Tim Dr. Chief Cedric

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

Cedric. the to Now I'll over turn call

Cedric Francois

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

year, progress in made. like the close would to out we way. strengthening our the XXXX, achieved another We some business while recognize headwinds As navigating has along I important team our milestones

we advanced revenue earlier-stage XXX% generated EMPAVELI net We We presented and III SYFOVRE fortified our with U.S. [ position. value ICF-PGM. data year-over-year Phase positive and ] over pipeline financial in CXG growth. our

ahead, treatment first, focused of Looking our on the is pillars: to geographic SYFOVRE. transform strategy X key atrophy with

site. third, our innovative advance diseases. pipeline, to maximize expertise to And Second, our in impact in complement rare EMPAVELI leveraging

GA. the view through with the is Recent the within SYFOVRE than [indiscernible] regulatory with leading SYFOVRE for our treatment atrophy administered that landscape the is #X, treatment December. confirm competitive more Starting geographic in XXX,XXX injections market-leading for U.S. developments

are to in time with in over on recent includes million which in available. than SYFOVRE's nearly of we dosing enable [ has market leadership over years, presubsiding most position. SYFOVRE's the new will Hence, a no competitors X approved history, strengthen sales effects successful unmatched launches this options and making $XXX further X horizon, only generated ] flexible the less time. in SYFOVRE one increasing strong label, us treatment

the to XXXX overall are key X SYFOVRE's GA priorities and heading into grow Our leadership rest the market. to of secure

We patients of by eyecare] early are less seen the than growth an only GA professional. diagnosed in are receiving and phases treatment. health are Of that [ estimate still those of XX%

Building the a new in execute. but is to have markets. Australia our our to strategy The primary to Administration team last international select we in pleased market commercial continue U.S. Therapeutic is takes SYFOVRE, Goods for review right ongoing. the We time, focus we were approval month from and and will explore receive Switzerland but products, regulatory

This the siRNA. As we the activity launch, the to is designed CX to systemic to focus APL-XXXX also well as the are on working and treatment in retina quarter. local combined choroid for trial as initiate comprehensively we our SYFOVRE complement inhibition. to continue plan and Phase block II the GA. we To through SYFOVRE a [ develop at this, second ] do efforts are next-generation approach We

standard the elevate in Maximizing rare EMPAVELI pillar. impact to Shifting diseases. second gears then of EMPAVELI of to continues the our in PNH. care

We the with EMPAVELI primary starting of theater in becoming also to launch PACFPGN]. [ CXG in look forward anticipated a and nephrology

clearance to with results proteinuria, NDA Phase supplemental These We recently [ significant data. on the valued in filed of hit unprecedented the for deposits reductions CX based the ] positive III EMPAVELI trifecta approved, Even we of were or expect that eGFR. more compelling launch age. If types, second regardless these disease of half of stabilization the in transplant and XXXX. status results was consistent

making to on this the recently the life-changing treatment closer Our of available validation application, [indiscernible]. its them partner, Sobi in received patients to putting

late immunonephrology indications, raft also trials function. for glomerulosclerosis The and EMPAVELI are Phase initiate segment to second we X planning half of in III to XXXX, focal

pillar, our pipeline. innovative our Lastly, third

to We advancing about partner [indiscernible]. Fc gamma look first are editing receptor targeting soon. this forward neonatal gene ever program of all you pipeline the We with our excited more to our emerging sharing broader with be the approach, and

are about future excited Apellis. of the We

potential a robust with EMPAVELI, our of now products will ] events, development President I'm programs commercial and of Vice with I SYFOVRE David to and now organization. to the clear clinical have X path our pipeline the a We that over turn calls and call David? investor profitability. we Commercial. David is from blockbuster familiar are preclinical Executive of new many at and [ sure using you earnings previous thrilled are he Acheson,

David Acheson

everyone. morning, and good Thank you, Cedric,

Let million injections SYFOVRE has launch. nearly me had remarkable a sales, XXX,XXX SYFOVRE. With start administered $XXX and over with in net

grow focus going and the Our overall to position leadership strengthen market. both our forward is

doses provides demonstrated The strength than more recent increasing clear. is the update confidence our now only effects from SYFOVRE ever competitor and has a few with consistently robust per things regulatory X payers. differentiated over profile. year in SYFOVRE's product position are only product SYFOVRE time. and of Three us is SYFOVRE as in many approved the that very preferred as GA for the

share maintained market to year XX,XXX and X,XXX over positively, doses including approximately share In commercial XX% stable samples. at ending remained XX%. Total quarter, the with SYFOVRE offices, the leadership physician and approaching new its fourth trended market delivered XX,XXX patient doses

months is the however, of There to continued sites remained As expected first of quarter. SYFOVRE measurement in commercial factors In of ordered a SYFOVRE's are, SYFOVRE. the orders of vials which care there true we in XXXX, and strong. more net growth revenue demand. fundamentals X,XXX affect administered inejctions are temporary first few number that are the of December, of X the than have seeing

distribution X,XXX or due X seen are Medicare have sample patient quarterly reverifications typical this over growth timbered compared XXXX. the winter usage retina volume and more and be the storms using First, And been market could GA QX quarter a co-pay the incremental of second, affecting to in We dynamics a has sample we as funding to believe the visits. samples in samples months. in estimate at because in non-for-profit used We like specialists average more there reported organizations. assistant quarter past spike gap overall also

in injection momentum each demand will stage growth treat can need beyond. we make opportunity in access has a approach. GA a sure are continued XXXX The to date sets long-term and a We for the who require specialist and Maximizing to the patient seeing strategic to [indiscernible] them.

provides initially who the positions, by only GA higher mean to physicians to adoption from continue We treatments. hesitant GA may those well utilize And status significant been products advantage. competitive with utilization as we with SYFOVRE specialists patients being our already as are have formulary retina who must strengthen further a treating preferred

to proposition our broadening real-world the DTC on to key our care connected initiatives patients through executing these forums, achieve differentiated value eye data We're key including goals, campaign. SYFOVRE's with and payers across through educating reach amplifying community,

and focuses We This of SYFOVRE recently X our who campaign are increasing connect GA treat GA launched them. Phase specialist able of and campaign can on Henry retina to to [ awareness patients DTC Winkler]. ensuring featuring a

EMPAVELI. Now efforts medical CXG year. teams potential The me this in into ICMP their shift anticipation commercial let up ramping and are later to EMPAVELI's label of expansion

of the launch. team running and impact us our process ground hit the early a in in field-based allow are make significant will the which of We hiring phases to the

engagement relationships focusing prelaunch launch likelihood These conferences, KOL disease are and CG with we and state physician payer patient a include the executing activities in and IC-MPGN. accounts, key These awareness. on in key participation maximize activities several of Ahead education. approval, building of nephrology successful

patients studied and They with estimated IC-MPGN also significant broad is nephrology commitment patient EMPAVELI X,XXX the The an CXG our and a reinforce rare in FSGS. in DGF be to population. is only U.S.. in to with programs our opportunity drug commercial the

Phase Given across the and all believe data, strength groups severity. disease used of III we EMPAVELI be the will patient

be on the disease In administration that given patients, with quarter. to efficacy over has choice severity treatment eventually will those $XX been kidney U.S. Physician the CXG PNH, of net generated the in and revenue suffer based million mild even moderate IC-MPGN. fourth will feedback EMPAVELI approximately consistent of failure. product in Many route

consistent XX%, profile high remained the rates Compliance our safety previous and updates. at remains with

call by be to revenue more than offset generated continued I expect IC-MPGN. CXG initial the in but With from competitive this turn XXXX, over and that, will now We pressure Caroline. should

Caroline Baumal

with everyone. start and good David, morning, Thanks, I'll SYFOVRE.

sepovial-GA supporting presented reinforce SYFOVRE's that consistent increasing patients as time. Earlier tissue of to that with see These treatment time. effects magnitude month, benefit over of dosed over non-[ periods extension GA areas continue XX-month SYFOVRE patients and data we from on retina demonstrated evidence monthly. disc study strong ] SYFOVRE ] efficacy data We our early XX this leads in long of to months GAIL preservation X.X average [ at approximately to

considered retinal ] highly the ] context, size of specialists. approximately [ which disc For X areas, is by meaningful is X.X [ Phobia areas

X of benefits by the real-world of reduced are concluded analysis beginning treatment of data to treatment, by that evidence GA XX%. real-world see an We SYFOVRE annualized the month independent growth rate of also SYFOVRE over of

Separately, data stable another injections. analysis acuity following of SYFOVRE treatment real-world over visual multiple showed

While confidence strengthen treatment these set in analyses, its to extensive there and independent data are results to SYFOVRE add limitations for always the benefit. clinical

the developing mentioned, the complement and for APL-XXXX, SYFOVRE blockade [ comprehensive may treatment believe next-generation Cedric in provide As in also we ]. a We combining retina and are siRNA GA. chloride our

APL-XXXX activity Specifically, complement SYFOVRE to the the inhibits is complement eye. and intended retina in systemic in target

with Last as protein degree With blood. may eye APL-XXXX, of higher even products CX following less levels from administration in I remaining the measured contribution the data volunteers of present month, there than APL-XXXX greater by in shared showing healthy XX% SYFOVRE. the Phase in we an CX be efficacy of knockdown of

SYFOVRE Phase study second expect in We a with to the APL-XXXX GA initiate II in and quarter. patients

Based inhibition, kidney The and in data rare in ability function, III half focal one one segmental rationale meaningful EMPAVELI. to and to Phase complement year, to confidence complement results diseases. ] [ in in to [ graft we the or primary a these delayed with with difference ] patients initiate control Shifting DGF. studies further Valiant for X of pivotal the and EMPAVELI's provide strong on FSGS or EMPAVELI this glomerulosclerosis plan second provided

kidney in no and are scarring glomeruli. There Similar in approximately of a estimated of CXG there plays XX,XXX kidney IC-MPGN, FSGS are end-stage pathway The patients. patients therapies. the the role that a an to and disease FSGS years half both causes complement within FDA-approved diseases, to for States. is FSGS in results XX currently significant United X primary rare disease

the of where requires typically patient fails complication overall transplant the a within transplant. of transplantation, is the kidney long-term to kidney in week negatively dialysis affects and function the outcomes. This kidney first and DGF survival

estimated deceased complement move DGF involvement directly XX% need, these FSGS and their into to XX,XXX to transplants. In XXXX, unmet the significant and high XXXX. due an were by XX% using pivotal U.S. chosen to potential approvals occurred transplants programs ability DGF were in of there in our donor kidney. with

to positioned treatments with these now uniquely our leadership call the turn to the of are bring and and to Given I expertise review will Tim complement we over financials. devastating diseases. patients a for Tim?

Timothy Sullivan

our Caroline. provide you, an Thank now will of financials. overview I

Additional we available in release earlier press that issued this details the are morning.

for revenue product revenue. compared to million XXXX revenue million XXXX. year fourth SYFOVRE including in was XXX% as U.S. and EMPAVELI Total net the million, in million the a was approximately increase $XXX of $XXX quarter $XXX XXXX $XX Total for full nearly

to the Turning rest of P&L. the

cost sales fourth R&D $XX.X expenses quarter, a $XX.X net and we million, of For $XXX.X million. were expenses million. loss SG&A was $XX.X of reported were the million.

to on We stable is through that relative low managing to reimbursement. the some help X% while to increase offset We erosion quarter. of to XXXX. January the to the anticipate ASP gross be SYFOVRE, took price range intended in customer gross a net mid-XX% remained X third to Regarding net

We in from perspective financial made while progress strategy XXXX. execute maintaining strong We discipline. our continue against a to financial

in nearly can you Slide XXXX revenue expenditure. see non-GAAP our As our on matches total XX,

stable $XXX of in cash cash position. be at With our million to in the compared in XXXX. anticipate equivalents We XXXX operating relatively remain to end we confident and financial XXXX, expenses

expect existing to sales combined future to cash, with be our business fund to product our profitability. our core sufficient We

back Now to I over hand the Cedric call for remarks. closing

Cedric Francois

Tim. Thanks,

CXG in of progressing the By patients are SYFOVRE shareholders second have our value this, commercial our success ICM for with our on we building ability strength and focused for on position. of coming XXXX preparing in financial started position over and the from and launch We solidifying PGN, years. pipeline remain to create and confident doing a EMPAVELI our significant

Operator

And Evercore coming Instructions]. be Miller first question of Jon [Operator will from ISI. our

Jonathan Miller

really I XX-hour the indications, all on a your and with guess, follow-up the progress. Obviously, UACR on the showed a Congrats and test then quick that. endpoint but kidney and endpoint. One on the results EMPAVELI competitor primary great had spot

that it the haven't yet. hours, the I have I the Some publicly? focused said great. FDA is a in on included most know looked in of submission past sense we Do that you you Do seen plan which would FDA. on you metric at on? to presenting the you be was assume that commentary XX but it

Cedric Francois

thank much so question. for that Jon, you

submission we saw but So order. the course, look, looking feedback we're At the of very course, was hours excited forward XX with with about what to the in and with of EMPAVELI, endpoint, consistent spots, was the short spot.

what is of [ that proteinuria], meaningful reduction the which that had just the we important is, but but this the has is [indiscernible] across exist. think consistency also a highly not had phenotypes [ disease. across a There I we important And all X stabilization. of ] clinically metrics such proteinuria really here of to course, all right,

snow kidneys, I these cannot mean, you and the to when addition that, impressive of CX away, histopathology, months detectable look patients a go have in over after months deposits CX the I XX% in see you deposits. much on frankly, sun, course overemphasize results couple X as like melting no at quite and the so as right? that of the of And the more

something can the do out submission will patients we that's soon for submission well. the really publication we're about in excited as come important mind, about what So the of and

Jonathan Miller

Maybe as quick a just follow-up.

half of to the agency a to Given coming meet level in confidence that and you'll get requirements launch review. recent sense out of its your will a get I'd second timely news able agency, the be you'll that PDUFA 'XX love of

Cedric Francois

macro, indication no all, time, point of the but but [indiscernible]. is Of control at current in there no course, we is type our there any have of at

Operator

Ahmad next Tazeen question Bank of of Our be coming America from will Securities.

Tazeen Ahmad

questions have Great. regarding of couple a I SYFOVRE.

So XQ? for be cited quarter be how mentioned. would you on sales that results metrics first that the or this in it should be quarter, thinking to just Could the relative the based you've really about trends first we in the lower that reasons quarter

noticeable status regarding gradually? patient that's year? to think have then an in share I you new And and the have that's follow-up. more would Advantage, happen going the do that a you in early then do Medicare beneficial think that on impact something Or And

Cedric Francois

to it going David. to over hand I'm

David Acheson

David. It's

anything we're impact we that while talked in we lower temporary, we of be to we to going think the And where as in call, things that, currently, that like seeing -- least do some for but QX transit so not be beyond we've QX impact QX revenue. what And a they the with will at about So are think that's result. QX than we're seen to guide in anticipated on net what the far. will are are

continue should QX expect temporary expect way, the of to have It's which of -- news, see which injections, for see XXXX the we is us. out in very one in way, the too, QX is and that numbers things we to the that the these positive as we the QX the call growth. other really get see to versus of some thing grow And positive talked impacts is for to by good seeing -- we once us is well, about and against we're note,

Tazeen Ahmad

you seem change to then [indiscernible] And is important it Okay. does monthly the based that will data will follow-up is it the docs until other injection have on Do was for because about label every label think now, change? relative month every for practice product. to our competing other my seem, month. that adopted IZERVAY the made How say, that

David Acheson

Yes.

out. here So to look, are still there's some here, label trying In I the to that folks a it's still little early I think right? figure change, bit think things regards

have SYFOVRE [ for in to And Macula robust had I is every this further time more us was is which And an to a in I second We solidify we were out, a that really increase lot data general at Society part discussion presented of I'll ] the that held meeting of which came comment. will have and was was when which going lot hand important dosing. the was discussion. is think around That a over And month at helped impact a talk that to other and some that that you myself consistent SYFOVRE's tell impact. prestigious the follow-on Caroline, the Florida. the that, -- and is to it effects meeting. even was the

conversation only be positions product the label That was we're can with has that the X year, Society. at the Plus, product and in [indiscernible] and treated, that as the it's as preferred few payers. doses for a we're only

So it to I'll hand for additional over Caroline comment.

Caroline Baumal

What physicians my driving we when a dosing. that comment important patients, consistently being every physician, are with from ] convenience and payers. have from hear factors really efficacy I other I And efficacy know demonstrated is [ and month for

IZERVAY did every them for demonstrated clinical not has not and FDA the This in been month with dosing. other approve a trial

our benefits, a effect includes dosing dosing. flexible increasing our that monthly regimen and over of label month includes So other all every our efficacy, time and

Operator

next Anupam of JPMorgan. will Our Rama be coming question from

Unknown Analyst

] is for actually Kuno [ This Anupam. Malcolm on

over What headwinds potential the payers IZERVAY tiering the label. the SYFOVRE? you with preferred on months for the last for from several updated So and hearing are

David Acheson

Yes, Malcolm, It's thank question. Thanks you. David. the for

So number a that have sizable fortunate position. of have payers us we're in to really and preferred a plans

comes little that to we up when looks conversations have I that. efficacy look tell a month at with that matches I payers, dosing we and label what have But will the in fact and think forecast down the with you, the to like. it that really it every to it's hard the

time. the we'll forward what point but payers, really keep moving things at the the see in this least to And I are can't at predict in in with happen mind. those will So what future, happens

Operator

from coming Sachs. Salveen Richter be will question next Our Goldman of

Salveen Richter

just a lower being than the cadence the of XQ XQ, on the commentary we should launch on XXXX, about there's us how bit XXXX. you color more but here SYFOVRE growth in in think given Could give little

and in ex also the for formulary And and a of context update label potential expansion the IZERVAY U.S. status

Cedric Francois

Salveen. you, Thank

first fewer which So disease. seen of this unmet injections right? in And accurate patients to geographic that And about all, by is need are reflection a mind, Remember, bear of important really been currently in the I patients only has of think, professionals. being XX% of grow, than to half [indiscernible] continue treated.

revenue opportunity patients always it to do has generate the been. as [indiscernible] and for there So to good is

enviable went we So that overall concerned. Competitively, is year, I as several motions. through of think frankly, we Last an far course, the is as right market in now. are quite position

end day, our that the it's or our CRL resolved that for really at important of competitor not bear has. the think I But now, beyond to mind then, shortcomings in is limitation was also it's that notably, the the dosing. out of month and whether lack competitor, fact XX-month for called that the every data of initially, other a there not did lot of Most know the a there physicians which course,

kind to So level think X was that important decisions. I of can the take the physicians set around it products right knowledge so

So heading we're very excited beyond about as where well. and XXXX is

Operator

Yigal Our next of Citigroup. from question be Nochomovitz will coming

Yigal Nochomovitz

will it for any more interweave be just to them? II have single the Or the a phasing is And dosing? OCO the then question to trial How had talk the can of ] thinking on systemic? about about that a this are you you combo Or Are given [ study? going I you SYFOVRE. XX combo arm and the arm? comparison intravitreal and with going just dosing Phase there the strategy

Cedric Francois

Yigal. much, so you Thank

question, usual, we're a excited excellent and an is thought right? in carefully you setting, our implement asking, which this we to XXXX physician as So about are to how super program,

the if with idea subcutaneous So CX. levels is that lower there injection, the systemic you of a

so should control off of and to SYFOVRE advantage, NDA to you So the still ] need if the the for, give faucet, cascade. want, [ activity complement which metric enzymatic strong dosing you advantage turning a

X and to intravitreal injections those administers, physician's which both which and both the to of the subcutaneous, synchronize will of months happen every in We X-month every office. the would

in are then posologies]. exciting so to have. looking of be something year this of this leader, So XXXX. context, dosing we share market I ourselves growing one the, we GA, be that's but as we to atrophy not broader [ what if geographic There as and think that can market the the the to the But I but we developmental will believe per strategic most end that truly growing that important. establishing X forward usual also I will mean, into a we're by explore component program separate those to in course, subjectively, in this the And year of really

Yigal Nochomovitz

for And maybe Tim. one

interesting Just the larger CXG, on EMPAVELI. down Obviously, pipe, indications DGF. the you've MPGN, as you have a FSGS, ton really coming potentially to, alluded of

on far even as patent indications? do you revenues follow-on the looks extend on given significant these might comments that any for how further you like, as the potential have So very

Timothy Sullivan

you understand Yes, exclusivity. sure. to -- kind Is correct you a asked that extend was correctly, heard -- If that there our I did perspective? if of way I

Yigal Nochomovitz

Yes.

Timothy Sullivan

have composition through XX with matter customary So we in of kind XX-ish extensions. of XXXX

significant reasonable we runway that indications So those patent ability -- that because to a that's for life we still chosen pretty that those we with the believe a left. discussed we of both would are have discussed and amount launch the

other that have are in things mind. There we

as We combination of work [indiscernible]. our that our mentioned, could really also Cedric have, the profile change product administration -- systemic ongoing of some

initiatives runs out. of XXXX from really composition that So where we're cycle But at matter is looking life well. perspective, as management a

Operator

Colleen Our next from coming Baird. of Kusy will question be

Colleen Hanley

you context percent to the put And you've much of achieve the positioning on expect had last how market year. preferred front So in in? some payer Can payer into front have strong the growth do momentum XXXX? you you on what more

Cedric Francois

you, good to back. And Thank Colleen. you have

over hand So I'm going it to to David.

David Acheson

hear thank from you for the you, and question. to good Colleen,

patient has Aetna example us could got the we've to a position competitive product. before ] and SYFOVRE start like [ plans So to with that move is a X great January big as they of preferred in a has some

plans So there. big some there's that out are

own that. And do little the bit PBMs on because to to accounts, in are on decisions their plans to the particular, that can hard at this. they want talk many so percentage-wise, intricacies with in I think downstream the make there what through a how look they it's actually

plans X decisions position but -- sizable make preferred you, their a for to on. tell in a have that of us will we number those policy PBMs I major in have accounts So downstream

Colleen Hanley

Great. on how That's we've that since have for might the read to opinion CXG through IC-MPGN, U.S. front, that and regulators helpful. European have seen and positive decision some the approached U.S. regulators review historically wondering review. similarly then European And just momentum

Cedric Francois

Yes.

So thank question, for you so much that Colleen.

So our partner, Aperia ] And very Sobi all lockstep been EMPAVELI excited and of of the [ the deployment in and U.S. in Aspaveli through U.S., this. about of we're global course.

I think we for be time be what's we the get and market -- competing and about out for what will there on approved many times, U.S., should again, maybe the kind only with We we estimate estimate we've by those example, approximately there of the other of product mentioned X,XXX X,XXX. patients. believe only highlighting we are X,XXX in it and the that

the really it's us, ] unique So that that partner, than are opportunity Europe opportunity X,XXX, and really it Aeris quite [ of deserves as special bit for well gets a with a the [ ] our in Sobi. higher within numbers prioritization ours as

Colleen Hanley

Congrats.

Operator

next question Cowen. of coming be Nadeau TD Our Phil from will

Philip Nadeau

is and on The you little made Can question. on just this that you of persist won't funding is a comments gives later QX follow-up it First, more detail shortage? issue what the and the And a why bit a go about confidence there's a follow-up you sampling. into the another year? in dynamics your

Cedric Francois

Phil. you Thank so Sure. much,

couple the are injections. help provide about we managed. That a that visibility which with the not just do And one is of that to stands factors, not have reflection all but for these organizations this of real product. a on for is but note it's to how before, are co-pay spoke intravitreal support SYFOVRE, sampling physicians the of is out to that look, what important we So

design how is their is manage by be organizations they that independent should fundings. it that This are appropriately determine

at of the has So before other organizations out. contribute we We but from run that beginning it and contribute. year, year can happen happened others contribute, the it the they typically throughout

towards a able those samples with So final still say the reflection [indiscernible] is gap, to hopefully, physicians the are right? go in sampling tend increase be need. take patients a, -- what that will of for funding of is to that physicians and that in care compensate happens the I There that these fact [indiscernible]. So temporary expectations is patients, would

Philip Nadeau

helpful. going Got CXG part that it. how deck, on to post-transplant your elements or is EMPAVELI, X talk you the example, there you And about the Can For that to focus other think That where then with patients only you're IC-MPGN. you and or a focus disease. outlined priority? you're buckets are on our will of likely In slide marketing? patients question of you option highest are be physicians

Cedric Francois

went thank XX-XX Well, Yes. the proud that you we population are broad, are as particularly these point which right, of, we as in we're study split Phil. said very something about targeting. that well going on we you that very much, CXG diseases Again, think is we I which ICGN, when we're to study

this transplant, studied which neglected. looked pediatric we depleted. that adults and CX transplant, We in We studied what as patients also sometimes segment is as is well disease is but post gets a pre at often happens

consistent as the response far was disease on we everywhere a saw not everything. concerned. as impact the it's And we Sometimes studied

means is forward kind where you're the that I of So are because asking what what is moving the -- think initial where demographics.

I one. think post-transplant the interesting is segment particularly a

quite I community of noting recent of with now happening worth Zero the being think also proactively taking the on of transplants pristine nephrologists, kidney just cases, or EMPAVELI. seen a news, transplants data have protected transplant are in that not EMPAVELI may [ EMPAVELI within modified reputation, because but we with know, all the that that as in this in is pigs Valeant], you [ it's all transplants, far the from because also are that had as genetically ] were small are rescues we either

within control our the kidney complement So something that, EMPAVELI well say to able to and I'd of growing steadily in the course, for bodes -- year. the of be later reputation is launch this

Operator

question Akash of comes from Jefferies. next Our Tewari

Katherine Wang

for So Kathy this Akash. our is on

label SYFOVRE? XX-month bolus and essentially rather So they sitting dosing March docs ] that once they to update stated IZERVAY them call, their expecting on such, warehousing [indiscernible] were then as the in patients until were And a pausing [ earnings than resumes. doses

So couple serve a IZERVAY you label, PDUFA should And other got do do doctors going what versus regarding needs we before weeks? weeks given to data the And of label then the IZERVAY your IZERVAY few dynamics SYFOVRE within X-year team SYFOVRE with seeing on versus forward? terms the month are in the of the updated dosing, without perception? what think but what on past to you then change expect every

Cedric Francois

Yes.

is ] rooted leadership. is is [ for intels that about will the it part, that I growing But message view I are we first some that That certain talk to the is over have, hand that we internally leader we certain very us. of been Caroline physicians home then clear I very course market will key clearly patients to currently definitive warehousing take think in very products. something doctor and over there So important. and Caroline are which I of to And that a think, have data look, that with I So the I'll about right? at from perception, Apellis all to the we with have is here answer and may talk think to the physicians hand how

Caroline Baumal

a X physicians data. very efficacy hear attended we [ about recently our ] Macula Well, enthusiastic meetings, just our colleagues Cedric. you, the are from Society. physician And Thank lot differentiated most we major

we I who've of and was was mean, for disc tissue SYFOVRE we X.X [indiscernible] with tissue been over data, much with use, retina and tissue And presented months. our data, that's patients presented long-term how that treated SYFOVRE saves long-term XX that

really is this and physicians. unprecedented driver key is the amongst So this

really the scientific and them. meaningful that for in I think physicians to it's the very that speak end data

Katherine Wang

-- but quick just Understood. was some Okay. seems And a color QX stable super mentioned ] could because like like It seems provide follow-up. to XX% about on inventory you versus growth sales then like net X%, your gross more in that quarter-over-quarter about was [vol you growth it dynamics.

David Acheson

David. Yes. Yes. is This

see did QX, and about move it inventory range of we coming a significant bit, we number course, have. way. in regards the in the out X- you'll And end the coming around that for we holidays. a you more you'll bit. orders of thank usually, So any may for X-week be some us a a it concerned situation was little move at in the part, in quarter, given a that And little in in not QX out little would we little a will in saw see see a not put any the We that most drawdown front of were to -- of bit bit sometimes the of QX. to question. that But typical quarter, out but

Operator

Our of will next from UBS. be Merle coming Ellie question

Eliana Merle

seeing discontinuations, term, [ terms thinking terms the In of about TA], we therapy of I of in you're what what distinuation be? long or and what's that guess in [ how of terms on any seeing should be latest ] adherence compliance guess, patient you're might sort the I rate

do beyond you I a XQ, the then just second on in guess, expectations of terms for the dynamic what samples of number of year. expect XQ of in the And terms rest question, in your

You temporary what just sales. mentioned over in a patient-assisted of organizations. the you curious of gap the this funding terms in But course expect the the of was year number

Cedric Francois

Yes. Ellie. Thank so you much,

we protection what to of to similar immediate are future that viewed and all, know, this find we see the make an levels tissue an preserve SYFOVRE as whereas will considering treatment a large to adherence, an So as it more acute you anti-VEGF if is what with with as is which the for investment of the amount trend, benefit, can we product. faithful SYFOVRE you have you all that in adherence of kind very positive relates first you be actually or with

around. that concerns no have So something that is we

have to samples, answer As will I it David that. the relates

David Acheson

Yes.

And So which a for in treatment important a it's things. seeing remember just upfront, couple is I very patient positive remember, think into sign of for of that QX is I increase think And samples being a and versus QX. put requested us. injections we're the demand, to

that. about good feel we So

couple of a things. think I

control all, that with the kind when mentioned, of these those manage being patients believe this timing together, the looks we're and the samples will as We commercial physicians. Cedric all is place know don't funding used over in -- that groups temporary, anticipate time. of and working this are product that gap like be it's the and really we things come what as it's that and on that the of that that far issues fixed with in First we

answer don't have that. we really to an So

continue will we be But patients in needed to supply and treated. put samples if a where can place they

Operator

Samimy comes Stifel. question next Our Annabel of from

Annabel Samimy

coming square just position about share. away bit than XX% to But the and community new getting headwinds help more the label you and trying for competitive of from understand trends then positive SYFOVRE. got growth, Can formulary patients I'm about So injection better little status dynamics the in leadership comments and talk that is efficacy flexibility of us positive around like from competitive SYFOVRE. you're we've a feedback XX% greater preferred expansion then new with the

looks sort can is that is to new patient up still what pushing it's for for guess not why headwind new help I'm I us because that share. maybe really but able the sort share well everything So XX-XX away lining of like you competitive patient it understand the SYFOVRE, to is square XX-XX of

Cedric Francois

you, Thank Yes. Annabel.

look, in ago, the situation community. say, So competitive think I would even we a but for of think was, the see a or couple course, will us, of were we it our direction data -- the where around think I competitor I right? positive months weak -- the retina I where in knowledge importantly, I ultimately up, right? end most is -- we'll mean

mentioned, physicians, approved this X-year actually didn't was As only do far What does do? drug in long to what run? as period. lot I drug initially A relates know that this as it the for of a does it

So that a was surprise. [indiscernible]

the now playing are and in on we right, playing incredibly that think playing efficacy a doctors. I robust, the retina level being field level So differentiation by is field, and that recognized is

on turning us add don't I on forward would And magnitude Caroline, longitudinal not we're from. basis, know, a the it looking to data. it's And a something? working say is point to for that also I real that's that just if you want

Caroline Baumal

X data Well, every robust studied month stay into I And other us. have patients physicians broad the clinical differentiates we the month the year show increase really compliant. one were us and with patients that things just every we to all studies dosing, of with that dosing. other which efficacy think use And a guide that the demonstrate help is will heterogeneous convenience

So I long mean, this population. physicians that continually come up every to speaks their month me, presenting other show and term it grateful dosing, for what patient to we're and

Annabel Samimy

did not clearly mention question I of there? [indiscernible] were a But a some curious ask on I'm little have a the What And patients could physicians focused that lot -- got Great. -- but are a level your out little launch. Okay. treatment. on get CXG, if MPGN earlier, expectations on You're to on focused more efficacy. are bit you more just urgency bit

early what expect so that And we can product? I trajectory for launch for, guess, an

Cedric Francois

Yes. Thank you, Annabel.

think we request get we I use key the ] that the thing demand expanded that in -- for compassion is the use we [ already see and [indiscernible].

XX lot which is So chance or not of a about is these of younger XX, their very over the demand you're whom are period, losing when kidneys. is half patients, XX% important. XX-year a Remember,

incredibly the need high. So is

of that the And I competing have, to want probably based will of be that patients. about data emphasize we again, bucket XX% for only on probably we overall that

So for for important a opportunity really us patients. and

Operator

be of Douglas Tsao Our will coming next question Wainwright. H.C. from

Douglas Tsao

was know powerful of spoken having past, so about photoreceptors very cells. less First SYFOVRE on the of RPE question the I [indiscernible] effect SYFOVRE in terms in had I on and product, preservation Cedric. a

the curious, this just by is going with a after the well? of specifically targeting is to what [ I'm chlorate], approach, of as you're sort case so which isn't sort RPE this And which

Cedric Francois

SYFOVRE is impressed Well, in What question, the robust about perfect. when impact but those look months. receptors. I first XXX% [indiscernible], incredibly it's correct. with the on X mean -- is photoreceptors that has very near I'm are so you an that you This on impact the

RPE is on in cells that side, if impact similar back levels, question the will RPE a right, can here receptors. ] the we to we down. lower course, if we're the eye, the able way that [indiscernible] the are be CX on continue [ today, the The is meaningfully cells slow of -- answer we since the then choroidal ones that trying of And to to

yes. answer is So excellent question, and the

Douglas Tsao

Okay. Great. quick just a David. for And follow-up

Just if impact to the I'm anticipate curious seeing this you it that point? the for at redesign this sort on quantify an year you of Medicare extent can or

David Acheson

you the Thank for question.

I would us, I at for to think and quantifying take guess hate that is challenging it. a

think with whole at manages team, least that do space the that we're something can it's course, that quantify I CMS. payers I especially got of So with a at all in and things don't time. our looking we But at. this We've

Operator

question & Needham Our coming will be next Stringer of Company. from Joseph

Joseph Stringer

Two us. from

about look? compliance for updated Sobi And your time? on any get on How comment, skipping just between that does the example, how over to adherence what curious injection. secondly, switching rates, changed wanted patients but Or question I that dynamics or Just has SYFOVRE, and about know IZERVAY. rates [indiscernible] for prior asked missing

David Acheson

So you Thank things. this for question. David. A of is couple the

some as of the touched Cedric anti-VEGF. think where it's range and Caroline about the in already and on I same with compliance we fall SYFOVRE

the is think good that's area about treatment to very for that So that it feel because disease a slower I than us is GA is something with positive of definitely actually, because -- I AMD]. and Wet in be [ compliant,

at had CRL as in basis. number of especially as the of dynamics that had [ end the As on the weeks, part far front the that saw product the of tell far a regular first the for they of still the on today number as seeing period ] And QX. competitive we're switching, a will that think question so a I of this we switches. that I we've look during -- we you

a thing I see versus think And that overall driving thinking the good fact to my good place an in in injections QX the is, and I QX. that around XXXX. are think we're And we what's is in that growth increase seeing in

Operator

will William next of Lachlan from Our Hanbury-Brown coming Blair. be question

Lachlan Hanbury-Brown

the I about efforts that wanted get ask off made the doctors to to you've more sideline.

changes towards shift new or of messaging sort into behaviors prescribers? physicians. sort the the with actual that efficacy-focused translate resonating I'm can said you if You that any But is wondering prescribing of well of

Cedric Francois

Yes.

for you Thank are seeing. we So question. what that is that

the up think really X the launch that right? message years the Macula study, concise what resonates at the I more with communicate. gratifying that can very is And SYFOVRE, becomes is Society, which to the data square to X right? much of on now have you is becomes We I of that after data of clear, main are have you retina most if is think preserved, X millimeters years one treatment extension

is That of retina a the in tell X resonate is real situation really the forward. The [indiscernible]. efficacy and reality one and millimeters one the becoming back now brand And areas, in of moving very stable a well. we is drug is That is can of that safety amount of health estate many square huge focus. use is this physicians incredibly the that

Lachlan Hanbury-Brown

still if more FSGS for DGF, there, up Got when and IRA you your I were what you'd life it. can may, And thoughts to doing assumed? but on sort there's price and of negotiations be of business a your color cases Curious just answers on the what would any EMPAVELI. sort probably get realize assumed questions great on [indiscernible] following follow-up, of if you for earlier for question give on patent you sort I had

Cedric Francois

so Yes. much. Thank you

And these So these a analysis the on what the did in of the readout that glomerulus. Valiant can competitive we do we the based is do of usual are X ] [ thorough [indiscernible] the we you we and lab that work emerge. the target did the in have biology, exquisite look, drug, where premise after -- that analysis, patent clearly the with the CCC situation, that engagements

we get will these indications So but we're [indiscernible]. more excited when full and follow, much the about

Operator

James. will Raymond Our from of be Ryan Deschner question coming next

Ryan Deschner

can on on state Have your detail the months? in more and a you you last few of saw evolved in and XXXX expectations campaign. expecting And DTC of duration based timing the give and to at in XXXX see in what what any for steady in you're to terms the net all of campaign sales us gross new beyond impact prior on the

Timothy Sullivan

the I'll net of to David impact hand over the then it and DTC. take to for the piece gross

the simple no. is answer So

And we guide gross XXXX, At changed the on throughout the hasn't of view David? all. that course and quarter, at of third the to the Our did event end mid-XXs to remains same. low

David Acheson

you, Tim. Yes. Thank

a you that We of television So in that ] that the piece happens of Wikler on can impact mid-January. It's one see. on But early an question Henry commercial running can give will of information the indicator that [ I with little appreciate you some I give DTC. started early. we

about run X,XXX during was have the that Saturday on commercial, anniversary visits Night special. the attributed to time. about did XXth driving which the commercial Live website, We We views million had on at XX our

It's So for to see early. the things several months. us to see like time we throughout take can the going that next total impact

Operator

one time have do And of Archila coming question our more for we be And will question. from Wells last Derek Fargo.

Derek Archila

Maybe to coming the for of talked and guys some just I lot we R&D to 'XX? 'XX? Is going how a you X growth that trends just relative there XXXX should of to be gross about seasonal Tim. OpEx the guess thinking And XQ in be I the initiatives how in growth from guess, about margin some we think sampling, based factors about. on should of

Timothy Sullivan

Sure.

expect that we be those So remarks or XXXX, as more said OpEx we less from same. perspective in the of our prepared the to versus

gets we case by some R&D probably some some increased. think that our that's about scaled of think from savings offset cost which -- the down. I European That when you infrastructure what we've expenditure will be

lot we perspective, moves perspective everything the margin color on margin a But guide And of gave I into that. think sort we then on that from gross from a could we around. that. from There of there's goes the project you that sampling how are perspective, don't we -- gross

don't do we really is in approximately we talk any an about visibility. of increase XXXX samples know quarter. that have we see But estimated this We what vial did

to get that, our doing can a so on you And file. revenue math of the kind per of is what idea reasonable

at impact would our of can margin in an be. that's that that first right frankly, get into estimate. You what the piece can the quarter, least as kind now gross And we understand

no Beyond unfortunately. that, really have we visibility,

Operator

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

Cedric Francois

thank joining much, and you, this everyone, so for morning. us you Thank

please free feel questions, much. Meredith. any you If to so out have reach you Thank follow-up to

Operator

Thank concludes conference And you today's for this call. participating.

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