APLS - Earnings call transcript Q2 2024 | Apellis Pharmaceuticals, Inc.

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Operator

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

Meredith Kaya

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

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

I'll over the Cedric. call turn Now to

Cedric Francois

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

which drugs difference execution been X are of and market. by [indiscernible], unique competitive potential that We a continued we there team, the a in the SYFOVRE. of recognize for making landscape today with questions the months are but in progress have the patients. Past and X around are one for a blockbuster period position Apellis both for meaningful

been long SYFOVRE a to runway some wanted motivated drugs, for lot available I category growth. focus this, a Given with X of dynamics. and market of continued is said, my share leader thoughts. the only a on highly has there in X.X patients near-term That million

new as as tailwinds half we SYFOVRE. every to its J of yet had new patients has starts saw incentive recently as much choose had in demand new code. Our by driven And approximately such factors competitor possible. drive They patient

been in in viewed over of recent meeting, has clinical patient sales we one new launch its been drive billion month's favorably starts the patients, achieving growth injections believe percentage this of more its $X.X potential. to growing the last surface being growth only administered The in history, best is the strong SYFOVRE's Following quarter. More every XXX,XXX GA market half time. to generating growth double-digit into physicians first and SYFOVRE of single over and and than has and scratched X by long-term The SYFOVRE second will is SYFOVRE in year. the continuing successful profile ASRS quarters have are estimated significantly, launches is

strong SRS was for meeting recent us our strategic and profile. efficacy the point focus Importantly, SYFOVRE's where turning and a discussions shifted our differentiated to

regarding presented. three, X,XXX no SYFOVRE strong been and injection. safer months head-to-head that first vasculitis while flexible rate have SYFOVRE per the the of is safety, dosing some multiple adjusted day stable and matching to to phenomenon. other offer analysis of stock showed takeaways. One, both every more benefit totality comparison have cost-effective a risk remained month SYFOVRE the injection rare favorable per and profile provide among are efficacy profile months, The is analyses clinically these a treatment of than data. for Note and enthusiastic estimated physicians one We to performed. Two, supporting retina proven SYFOVRE key with with as about doctors non-simple Every efficacy. And with even be from treatment XX clearer has better maintaining an X. detailed clinical the other in at at SYFOVRE both treatment competitor and its XX monthly appears efficacy first patients indirect is The becoming trials

continue market well for years it be first cement rate and the During the appears come. we many GA positioned committee growth agreed that leadership podium presentation to believe further meeting, the that on at and injection. After rest this our only this to to we confirms are ASRS, to estimated in continue

This sir. patient every focus access drug. on to singular expect to its to path SYFOVRE ensure that multibillion-dollar becoming we Our of is needs a is who how has continue treatment

As European by the back an are are unexpected encouraged reset that We of learn to ] opinion. initial process, the to CHMP review focused that this day outcome we given and made by XXX CHMP therefore, not [ and on original the with the review. a opinion, reexamination multiple process negative the in led recent encouraged GA were throughout disagreed record opportunity, shares. financial was was for members This the progress we

measure as the Additionally, external GA. aligned were experts the functional of best advisory microperimetry on available

We the retina we appeal. new for designated the heading reexamination, community. believe broad we expectations final conservative and are the the be [indiscernible] XXXX. And fourth were continue our to we we of well by positioned decision a expect in by are report European quarter issued support the into recently in the [ humbled to while shown remain To

Moving to PNH. with [indiscernible], elevate standard care the which continues of patients for to

million sales $XX.X second product generated in Aspaveli in the quarter.

demonstrated as rate. We XX% that to compliance on continue are by experiencing Aspaveli believe substantial its benefits patients

Valiance to the yen this to to the we submit expand line for potential exploring process, and a present top is a CXG approval. milestone and best-in-class expect unmet Importantly, additional in option upcoming The If we to this III primary new data its positive, later readout Phase this in are ICMP into we are [ FDA ] supplemental treatment areas. indications high for become the month. need data next plan and NDA

core has from year. And are creation forward the having flow, sharing capital of a taken positive phase our look advancing Regarding our Day we sheet. next We in and generated the are multiple We to at financial by rely balance Aspaveli revenue earlier growing from future clear now science invest we on steps product in actively growth markets. the sales and for of to have progress strengthen stage of the allowing without to the fuel to Investor an to SYFOVRE development finally, us the benefiting line perspective, to a end programs pipeline, expertise this complement Aspaveli. new upcoming leveraging towards our cash

activities saying who first to in important has now thank by to commitment bring to Apellis close Before I support the I periods these the you patients. shown do our turn us us unwavering patients unbelievable will have it whom over the to and to these years. Adam. turn And to to us shareholders, motivate And physicians and it team market. and with who provided discuss over to over and to units that, dynamic will to important commercial Adam medicines develop of many through getting I With to our treatments

Adam Townsend

our and SYFOVRE June rates quarterly these good second growth launch, the revenue Cedric, begin than XX% at will morning, million, strong more products levels of about longer-term at In a $XXX and I with Thanks, remained our of sales commercial month quarter-over-quarter. growth everyone. SYFOVRE with second indicator year delivered of XX,XXX of to through demand. We are in continued the over launch since doses the demand accelerate samples quarter. with strong approximately Demand second highest being quarter. X,XXX

to which We including the many on some a continued across progress know I base. everyone's driving are the Cedric patient see pleased mind. new competitive mentioned and demand particularly factors the of is dynamics, growth, broadening prescriber

So there. let's start

Our competitor as had such recent tailwinds J-code. driven by new obtaining factors its

so accelerate. new see proportion of it their that is And they patient share would expected

when October. SYFOVRE's We last J-code into effect also an went saw acceleration

dynamics. do this not longer-term of believe we indicative However, market is

lead a large time. discounting growing this taken now price long is believe and that and have market and to view a aggressively degradation contracting is We we over as will too on believe unsustainable

position differentiated strategic benefit reinforce patients the profile. for of our with market in are as also #X remains total chosen to SYFOVRE market SYFOVRE's risk flexible dosing. approximately the of plan GA efficacy defined We by the believe its executing to the be treated. XX% the by treated and will SYFOVRE's continue We treatment leader driven field profiles as number

also Importantly, we category. focused market on the leadership GA whilst are overall maintaining growing

We are beginning still the in stages.

who been an data of eye currently diagnosed and GA claims about professional being patients on treated. based care have by are that estimate Our are XX% is managed

that In the have are or addition, diagnosed and a portion opportunity reinforcing patients suggests GA surface already patients majority receiving not that that we small SYFOVRE. only referred patients of specialist. specialists, were by to a yet treatment meaning being diagnosed large have newly the seen most currently treated been retina of the scratched for retina This of only referrals,

everything I meeting I our care After than X,XXX learning of the educating were medical quarter, next ] strategic As at time on developed X-phase X-year X a about community Phase last the our this and SYFOVRE. phase we market. and have executing focused the being around on ASRS safety. This on we growing past commercial the we was a strategy. strategy which of of call, focused line. [ Phase mentioned XXXX, More we with now are leadership in sites in retina time plan the shifted to earnings our ordered transparent is strengthening

for users, SYFOVRE efficacy communicating of is number SYFOVRE, and on simple and given and with increasing foot, physicians, disease. message using and our over GA existing SYFOVRE's is access chronic establishing clean relationships front the We effects deepening we are patients. With strong are now awareness education that time, highlighting new which critical a reimbursement our increasing physicians payer expanding a

the risk study, in the productive messages extension the and forward our demonstrates We with data month meeting benefit dosing congresses. a for option allows upcoming successful approved first positive with other are having GALE payers. for that retina ASRS also dramatically benefit had big We these patients, every doctors treatment ago, from few function a a the impact a only X look data discussion the an sharing microperimetry endpoint. This for GA a weeks a visual meeting prespecified to leading and

choosing as continuing market. With We broad are them of referral GA for providers developing patients more we on who referring reach eye of secured and Reaching broaden the SYFOVRE. see specialists to physicians well educating to tens and these our rent have thousands care other key GA to unprecedented patients. are coverage also as payers, the process

share managers treatment made thrilled formularies. commercial have are only recently large benefit the We national pharmacy to SYFOVRE on preferred that their X

have that the commercial products, nonpreferred with to patients means exception an will to first-line and new As the treatment, the access will products. SYFOVRE undertaken for preferred full this or process as have disadvantaged be insurance

decisions, robust more in SYFOVRE's X propositions, in time driven PBM strong importantly, and and considerations SYFOVRE's compelling over economic [ proposition. we These decisions by every belief dosing. several other month efficacy, clinical increasing its with demonstrating value decisions payers monthly such have payers While effects these important were and believe milestones, both making are value highlighting ]

launched SYFOVRE. we've first And patients, is branded their spring to treatment As critical with to ensuring DTC about in our broad reimbursement coverage specialists. talk on of GA seamless campaign encouraging phase focused which the is retina physicians for patients with the and

and We in phase Henry order are ] extending beloved this branded long the to a next quarter. This excited Winkler our [ launch with will very X be the large methodical market, to in our term. for up of set is relationship Phase we DTC fourth executing the in campaign, ourselves

getting on that can to doctors, focus We we efficacy the and GA patients leading and the more the payers execute will benefits continue to flawlessly and understand drug deliver.

the Now product let in second shift million net continue approximately positive the across indicators leading population Aspaveli to sales. for The PNH In quarter, the XXXX. into trends Aspaveli. key patient me generated $XX.X U.S.

strong we very compliance at Specifically, to remained safety high XX%, a profile. continue rates have and

said, As next a X are with treatment XX to we be months. for sales we expect competitive least and to [indiscernible], of previously more an the the flat facing at market availability oral through

to have patients belly switching continue been treatment, has new to in We offset oral. an starting some but patients per by this

over is available indications, we regarding Finally, larger no Caroline? from into Aspaveli This and approximately now than and that, the ] of is deliver in treatments. market I much rapidly we market If opportunity Xx the expand will Aspaveli the turn CXG infrastructure enthusiasm our of potentially PNH leverage nephrologists to diseases. PGM. thousands [ there Aspaveli these reach to confident centric ICM echo to suffering are approved existing these that and call With patients our Caroline. the are can to

Caroline Baumal

good Thanks, Adam, and morning, everyone.

retina [ developed with month. the this forward we a group. geographic are have at opportunity retina members by retina no a oral sharing successful meetings of in continuing at late-breaking was reinforce treatment geographic are engage points new sensitivity over X with including the geographic preserve so, doctors visual meaningfully benefits. accuracy that and to all the one every a the community. This treatment engage of both Gale. this time effects where ASRS atrophy. was SYFOVRE to the and significant treated the the SYFOVRE, for the pegcetacoplan I'll meeting on and shown data results respect functioning. These year, looking function ongoing differentiated valiant months to function recently of of is to visual a compared first growth ASRS SYFOVRE about with was we visual this We more or the therefore, these repeatedly for important month, body to patients the as are longer to doing opportunity many share talk and lesion will have excited the largest minute. I a monthly slow the we from ] progress our and meeting heard to a had areas demonstrated crossover presence particularly team its of light the as points forward patients and atrophy first abstract measure community unprecedented in benefit from this to with with about We about the lost on look evidence that other later SYFOVRE most We by meetings presentations, with Stockholm, of atrophy talk patients our ] had add prespecified endpoint, XX data visual a highly upcoming analysis. microperimetry sketometous function. sham [ from to showed function by fewer geographic [indiscernible] in Results

to XX lifelong share CX. of a debilitating top VALIANT in Phase kidney activation to later and dialysis, people pegcetacoplan diseases CXG end-stage X kidney and are living results Moving expect curative. IC-MPGN, which in adolescents breakdown about years. Treatment III of rare and neither and to advance uncontrolled this kidney usually from to caused Patients are or failure transplant X generally line study are of by options Aspaveli, diagnosed and we complement month, with our XX%

key of populations XX% single recurrence up largest them the all a week view The either disease statistically of a UPCR, We or primary XXX marker organ. response of enrolled to in CXG Phase XX ratio, primary disease as trial end progression their as baseline. III this IC-MPGN. patients achievement about experience nearly VALIANT In in and protein-to-creatinin urine transplanted compared patients significant endpoint patients at of these transplant we half study This success the or fact, to well shared in is losing primary log-transformed with trial secondary points. Physicians NDA meaningful the for as some end post-transplant trial Valeant disease. The FDA conducted enroll and native the approval. to additional the of submit is patients inclusive endpoint for patients. be of the this of the a clinically positive, Valeant effects to only and to adult Phase of and would that positive supplemental population plan III If a have these adolescent is in the study with forms ratio of broad

our Investor given of study, [ We ] to completion the Vail the we to option Following the XXX% the have Valeant Valeant study, CX of to to year. patients the excited I over beam advance a extension at will our study. the Tim have an who Valeant enrolled the such in our are patients Vail. completed now were you our encouraged already were enroll Phase that later Day as that pipeline now SiRNA currently pipeline, into programs we turn are of for long-term [ Tim? I financials. highly more development continuing earlier-stage call into see ] Beyond said, Like is review the to and details about Cedric share with collaboration. this

Timothy Sullivan

I Caroline. you, Street. provide will debt and some our Six overview now financials of comments refinancing an with on Thank our

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

million $XXX $XX.X This in total in revenue. in quarter the second $XX of including U.S. with Total the million net product Aspaveli revenue XXXX. SYFOVRE revenue was million, $XXX in quarter second XXXX million approximately for and compares

to rest P&L. the the Turning of

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

our look the year operating expect in Street stated, significant to than cash resulted ] in related with are been favorable debt strengthening and that at Sixth sheet. to our discount [ XXXX free we May. total ultimately in in year, our and less allowed restructuring our was. announced collaboration how XXXX. This deal A in efforts continue As terms our be substantial us SFJ this efficiencies realizing The quick of we've this to to R&D on expenses and at inclusive to we These strategic XXXX, refinancing expenses SG&A deal flow. previously non-dilutive reveals I up prepay a balance expenses a focused total

debt to upon facility million immediately remaining this available became time. with million, $XXX closing. of over us provides our can First, $XXX up the access at million which We $XXX option

to to $XXX to few Importantly, from this SFJ over years XXXX expected deal was replaced debt We neutral repayment next payments when to is in pushed to due out with SYFOVRE closer be $XXX Street. million Sixth The May peak. revenues principal million are the Apellis.

of which in $XXX with Street and financial becoming longer on that positive us on Our rely of where aggregate, XXXX, and also the a first the markets the to from no and June overall to year, had flow are a $XXX call million strong the bring in be of our million more as provides million the nondilutive payments capital and in were $XXX puts nondilutive are over on to at the includes $XXX a to position from at certain business. spread. profitable $XXX the XX, million unlocked And liquidity to cash cat improves to continue having credit including we growth. equivalents in we invest of history. In million we flexibility we unwind it end $XXX capital in million an recent of The to fund least in quarter. have then. This some low path cash access in the nondilutive and can milestones flexibility. This, announced the accounts capital, line, have record deal interest-only $XXX achievement best increased in in until to biotech substantially cash $XXX beginning since through the incremental we million seen million the financial receivable flexibility a Sixth combined Plus, in total terms

possible Importantly, non-EU the scenarios. our ability in and as EU to begin generating both cash

the in is we the Cedric? peak U.S. sales remarks. is in of closing the much and growth longer, back I Europe ramp remains near profitability over in Cedric hand main opportunity believe to for source so will call to While the significant, the now the term

Cedric Francois

more first had I the ever with products, call continue year in half We've the a development and our And commercial very for strong strong to of a the will open Tim. value patients and pipeline creating X am support position now shareholders. than financial a questions. Thanks, of our innovative ability our programs significant in confident to we successful business for

Operator

[Operator Instructions] is first line come of going to question the Miller from with Evercore. Our Jon

Jonathan Miller

I is more -- I'll post flow share positivity, the would guidance launches, again correlator expect ASRS? you with a cash mentioned doesn't more in just Do around of of love to that anything then currently assume mark with guess new than I than starts successful does XX% the U.S.? existing GA start your grow to the you but start to this. the to it starts new share U.S. assume And

Cedric Francois

Great so hear much. you Thank to you.

fact leading very most move the efficacy, the in as there's of and mean very now out quarter, second and really large new were So on [indiscernible]. But there tailwinds we starts dosing course, is, encouraging to have important that is forward, for what I question, stands right? the the as discussed, see we value. is is what a economic flexible that and SYFOVRE market

advantage very large recapture forward Adam, to now, of market you an something? plan injections important and this want move we with as add So unmet first on need. lead take the do to we those

Adam Townsend

John. Yes. Thanks, Cedric.

growth for month to about GA the other talking We're we can encouraged see into future, Phase front dosing. every We're drug. we're in II, we're seeing We're about and differentiating the yes, talking So and that efficacy. we're continue drug great will see we July. already demand on in the We this by #X be and the market. are These can factors huge the this foot.

Timothy Sullivan

our flow, cash terms million was of in OpEx. revenue So cash $XXX.X and our

comp was that So depreciation take that. out stock-based and if just you under

than bit that less a little was So XXX], [ that.

really are on a cash basis, basis, on neutral. So total OpEx net a we

working are expense. and, So course, is right now the interest of capital difference

of growth something this terms given will So it the guiding really I when us become to to and the don't the flow cash We're market think positive. doesn't in growth we market, that's take for much in are But [indiscernible]. size not happen. that of

Jonathan Miller

be, positive more the would on follow-up my approval seems your in guess it I now And past. language EU than has

You mentioned assumption. into positioned that's positive you're than we little I heard appeal. all And well the this bit think were a more previous that heading messaging

base All you case, last higher approval the appeal? of really an feel our do assumption like feel but further of is do further thought versus resubmission time Do or now was likelihood that you this trials now? you was the much how without hadn't you how an not without

Cedric Francois

What for is, appeal course, the speaks procedure from was ] to the and the prespecified was is, should and data, the nice reset that introduce consumption, same. really remain expectations one includes of us the So that the of the to of that's the which important [ disruptive and course, endpoint fact takeaway new encouraging really patients. ability something

has not again, according gone look plan. disciplined, to has the share and expectations, that results. We've we to in forward fourth the of with to quarter terms changed. The been So process

Operator

next going the question our of Rama Anupam with line come from And JPMorgan. to is

Anupam Rama

us on your quarter. what month-by-month Maybe for is the how sort J you think you quarter? a were are do could the in were half was color like launch. guys that reacceleration -- then of basis month since give SYFOVRE and noted growth? more of within You on the we a the Or Was quarter SYFOVRE, first a code little what about best June of more dynamic saw impact the like you dynamics seeing

Cedric Francois

dosing drug and focused we're may excited here Adam, something. will long as it's and the well this we having you in want Adam, a flexibility [indiscernible] that on what think to Thank that fact us much, is what is, large meaningfully is stands add market for efficacy over here what super really and hand on. a are duopoly that be I the is a But time fact how I that you about differentiated that so Anupam. will it again, to but growing out

Adam Townsend

plan, of also So for metrics, the accounts grow yes, launch double-digit growth quarter for getting June QX us now into we think to Phase the multiple steps of highest X fully we're the is was a flexible we talking right? of really sites our date. about and think move what now quarter that month to I very saw efficacy, was X,XXX though, across of of in I right? highest We quarter. We're some initial quarter. month care. saw to happening dose. and the can witness what next And we that's June the Talking that about months, multiple the We pushing successful continue hard as Across

Operator

question And with of next Salveen Richter from Sachs. line comes our Goldman the

Unknown Analyst

Salveen. for on [indiscernible] is This

to So what could GA you're the on permanent factors evolve you in are over market the that competitive the how the you to speak And near seeing share the market competitive expect and point? the code this J following physician driving the which at [indiscernible]?And dynamics, for term? are dynamics that

Cedric Francois

so you for much Thank that question.

was continuing plan SRS be confidence the majority We was we for those the there, SYFOVRE for of were that And the there. meeting see clearly efficacy the a very market discussion around profile. safety, differentiation -- quiet on right, is on important that shifted was versus much front. is the stability real are competition. leader. of doctors and the So which market It towards those us, turning the the that on a and where was based really point to leader, And

mass become the more focal more dosing. the forward, have differentiation, efficacy, we long-term enforcement as other and the data, benefit and of points data move will every amount and real of now then month the that we SYFOVRE the with So

[ fact the help also injections twice So patients as that safe ] offers that, member as of the that injections. is the convenience the smart intraductal

things you of add going to these into know, want Adam, don't come something. to are All I focus. if

Adam Townsend

Sure. Yes.

you to So noticed J obviously, tailwinds certain unlock we had code our go our we code, new accounts. to when J if back also

at and of is competitor that X even said, Cedric new maintained as plus our comments So the of leadership successful market of some forward approximately to positive the starts XX% Phase tailwinds, had ASRS. market. That strategic with execution moving tailwinds total real a from XX% some we plan, of down, those

market also share. asked about Now you

So share patients. physicians into being we files into market and track based injected going then on

share, And robust market measuring think the way we most market we share. and a so of that's XX% had

and that, as our continue hard market incredibly think efficacy we economic that our value, convenience our on and grows, the will we maintain this leadership. Now message, dosing will push to

Operator

question the our of with from comes next Yigal And line Nochomovitz Citigroup.

Yigal Nochomovitz

Shifting over to [indiscernible]. think your this oral thoughts well to what And assuming to be that mentioned you as I the competitive ] endpoints and market, Caroline for wanted volume how get on other to some on it proteinuria to do CPG we of as in positive. is position we [indiscernible] expect with just need show secondary the [ the emerging options.

Cedric Francois

Okay.

for me. here. Tim expired [ ] hearing Sorry, we hearing who had a trends it has time hard

look, a in opportunity bit something PGN, as and know. really is about the This opportunity has but that the been you most CXG very of below large radar screen important little excited we are So ICM and for us. a

which seen disease. really is best-in-class this NOBLE where the histopath results the from study, within ever seen data, have We have we the

have around is excitement the this also yes, for -- science drug And reductions in not already We while seen XX% in in the we the this study, market, the approximately have NOBLE drug. proteinuria. seen

statistical really pay transplanted is, meet us that -- primary significance population. is then to the the to and on for goal attention to the of So course, endpoint

answers I question. yes, that hope So your

Yigal Nochomovitz

question guess of the of in that's another Valeant. design I helpful. And No, terms then

data terms groups? for separate difference study. and the how on one will in both CXG competitor that indications. Obviously, the studies being significant implement of combining is a as physicians You're and for interpret doing IC-MPGN as Do both you those see

Cedric Francois

should to what have Yes. out for very study, We So the way enough both you their think be of with course, to I important up viewed way the will with right? both we into reads decided in the include is that would context of, CPG depend hope our find which abate. data and good debt, seen study point, level. in That which be on the that the in bring the a one CXG

going not. been if obviously, what has stacks data the And see case how already months. So in to the we're by against Novartis disclosed past that's the or up

Operator

Our to going James. come line Raymond Steve next question is Seedhouse from of the with

Steven Seedhouse

life XX long-term regarding the a sheet change million item that sales Has that balance it the in going will question, any gone subsequent months you there quarters? Are grow? the line trajectory also versus what Or to in I that entry? expected shelf First then entry. anticipating been new $XX guess, of just is the entry prior? next for comprise to be is materials, inventory, the And on raw

Timothy Sullivan

Yes. Thanks, Steve.

we was because entry expected had long EU in our factors, our the SYFOVRE ALF. ] advance, ordering success for [indiscernible]. ordering also do include that for our the inventory and couple in we of in which So delay There's have of for a to and from potential other put [ place planned also

to we So have well for that in advance. plan all

in of to [indiscernible]. most much And so fact, has that, of it do with

has how more. line most So inventory -- know don't shelf last or will of life of long that X that a item there, but we exactly years

in dynamics [indiscernible]. but So place -- we about, put primarily it's because talked in yes, that we just of the

Steven Seedhouse

in of net both maybe on negative Okay. dynamic into has you -- unique to has net know. switching And has net been have the patients it sort do [indiscernible] patients terms SYFOVRE, so, and Good then of a of it neutral positive, been on drug? or either visibility that And of good if switching just between directions there?

Adam Townsend

Steve, Adam. it's

do, now, we with it's visibility only some the market. that analysis can obviously, all that have to of total a subset yes, So we

have what to is come We switching [indiscernible] flexible switching the on So there and of forward majority on to [indiscernible] seen the is saw one based from piece and [indiscernible] last we moving to set. a very some assumption our small bucket. back did based [indiscernible]. SYFOVRE in of [indiscernible]. And seen actually accounts year, obviously, It's some we've our dosing be SYFOVRE tends that's from we see data the drug. X or this to switch

for everything of it, as a lot that the far. new and that switching And [indiscernible]. accounts the look really really, number seeing we starts. and our we're of think what push answers piece this all more beyond, the dose efficacy, to really, multiple your leading using if It down piece confident efficacy see and seeing includes That As of includes and are increasing by about SYFOVRE includes into forward the to really execute that's plan writing small we it. we're Hopefully, of strong across value. physicians of starts right, to first encouraged strong We're new a question. metrics economic metrics time so demand QX that flexible on a

Operator

from the come from question is next Colleen of going line Baird. Our Kusy to

Colleen Hanley

guidance you Can on might for Great. any when you revenue SYFOVRE? thoughts provide provide

Timothy Sullivan

Sure.

but we're obviously, So not the guide what it's of and year, on not reconsider for remainder guiding providing year, it for we're next we'll something this yet. we

Colleen Hanley

you [indiscernible] review? recent the and have on raptors you from And think ] the dissenting background then the new been if said of of I provide review, them the selected. for most commentary were either Can any vote [ the a

Cedric Francois

Colleen. you so much, Thank

that. on details provide don't we So

fourth gone stable. we mentioned, have the have much be remained with consider And we'll in As The news. able also process to expected. success quarter, we line back what the in had with positive come to hopefully, very to

Operator

next Nadeau question Cowen. our to come with from TD And of Phil the line is going

Philip Nadeau

environment. competitive On the

First, the the center are the solution in the? [indiscernible] what using [indiscernible]? becoming a repositioning the versus other? in SYFOVRE [indiscernible] bit patient do [indiscernible] level you second, overall dynamics and the about they of And competition, Or position both [indiscernible] versus little center

Cedric Francois

a our know hard or your very question. Phil, hearing have it's time I we don't line but if yours,

Philip Nadeau

Yes.

first, what on [indiscernible] the are going competition, center are you one level, using So on marketplace other? talk the on Apellis second, you is versus then in And on the choosing Or the sorry, seeing patient about physician or on discounting? can they patient on patient -- what discounting, are [indiscernible] SYFOVRE? And discounting? by

Cedric Francois

Thank that? to take you Adam, want so do much. you

Adam Townsend

Yes. Phil. repeating question. the Thanks for

growing we're obviously contracting surface market. in process a large really we market, we've only market. thoughtful just taking how and standard So and and of This strategic the into this market. in on this patients is is moving view a And a the scratched contract

look forward, market this to how can is value be. as want to you So possibly as big much if possible. maintain We

of to been second question. thoughtful contracting. Then your incredibly we've your on So part

flexible comes [indiscernible] interactions, And efficacy, robust And we that have that these conferences level, too. many are physicians dosing seen physicians evidence. SYFOVRE So are at its interact now an at for other there leading well-documented consistently account choosing fans. when and with SYFOVRE real-world profile the right, we and is its safety

a know, there profile the with are SYFOVRE, no wants surprise tend will lot and safety for and to have its be patient is efficacy Caroline discussion Now their who always profile. explain we have thing afterwards noticed some [indiscernible]. physicians competitor physicians competitor and to the comment of about also a I choosing the One don't example, for

some either. conversation the And same on will physicians have

efficacy SYFOVRE. you So the add? anything this drive to will that choose also important to we And patient patients want voice Caroline, discussion. want truly in believe is to

Caroline Baumal

Thank you.

driven speaking monthly when it an to just dosing, which had efficacy. [indiscernible] goes less patients and some the GALE think into patients we use ASRS, have continuous high And comes the SYFOVRE. physician with of to they're study, with also over that use with by use, is really very driven data colleagues they're yesterday, third consistent of that have of X year at than I completed my years

to is with thing important give patients. the most to the for efficacy maximum lease burden So the them,

Operator

from comes the line Akash of with Our Tewari next Jefferies. question

Unknown Analyst

This is on ] [ Akash. Amy for

to year. this alluded So second safety you've update of half a

SYFOVRE. an can titration run compared dose we has Just [ update wanted get to dosing could in of what or on And ASRS doctors half-life you with a out working of a spaced that to SYFOVRE? to ] get looking studies shorter that? for sense amount half given Also, entail. PEG [indiscernible] when at regimens Are

Cedric Francois

that Thank you question. for much so

safety well the all, now clear of first is and established. very So

then us important was fact primarily Risk agreed this injection that that the on the So one well very phenomenon, of there, on for is -- every facts. where specifically rarity Apellis events, against injection that the important is these what you first in a context up of ASRS right? So with safety SYFOVRE end the that available. ASRS of it -- really the Committee was those dosing stacks in X,XXX and that month the And course, place broader first the are of other also because

And of think is and coming like. becoming where field. everything I going go. within lot XXX,XXX there's looks going this to we that is more what don't the based very around really about quiet to the well we I out much gratifying efficacy think will talk is injections, is. an to be what ASRS the know now safety discussion that. What is is recent What a more of see was enormous denominator more So really on profile that discussion

only in are really understanding right XX% patients with that of now of the market. years patients been and come. to rest So they going this treatment. They for are get [indiscernible] profile have is return GA it's and treated. efficacy desperate for to the blind These safety going across important the many

is stood that really that something out. So

as every well. any [indiscernible] There of time happened, is to is terms do? do? in a something that an In [indiscernible] what and can It's, X,XXX X is infections with you one it when What of as carry question, it's risk mitigations type drug. course, of normal getting But for of good. it event, it chance [indiscernible] this you a injection. of as rare should injections

something if something. I to that looking forward wants really is know this don't Caroline to. we're add So

Caroline Baumal

and tell that really this would if we're think [indiscernible] indicated. patient feedback. community retina no the have for you that giving by with appreciated I of by was driven care. And sort feedback driven they're continual I problem I community and science best is our our transparency will different partnership. the what the mean that has And

to pleased care. they're data this really continue So the develop to with they're with and and more to them us excited really for best our give patients work

Cedric Francois

[indiscernible]. mean, I ASRS And was feeling think the this that really -- Yes. momentum we're quarter. really I it's a real

Operator

is UBS. line come Eli from the question Merle next of to going Our with

Eliana Merle

one question SYFOVRE quick on a a and Valeant. Just then on

for I before, in versus post Sorry settings post efficacy any if transplant thinking in can versus patients? confirm setting? in you how size you thinking about this then July pre what's June just for the about pegcetacoplan volumes for the up relative meaningful And missed these Valeant, SYFOVRE? if but transplant are were opportunity then in how clinically X difference the the just pre of and commercially, versus population you're And between expected

Cedric Francois

do Adam, take want you to the first?

Adam Townsend

Yes.

strong because execution the growth plan. continuing really We're and Phase it's we're of across onwards. think quarter multiple expect thrilled it's and we of to down flawless metrics, So I it of X July, the seeing and rest a continue lot with for the our into to

[indiscernible]. we're the what to we're We are with now we're thrilled pushing on seeing July. front foot, and

sure. hard to make expect work We that We're continue. going to to

Cedric Francois

And Valeant, then to versus post pre as relates transplant. so it

because that kidneys kidney a a direct us, for your by also biopsies and as embraced on best that of it's Eli, is the this to what it's with deprioritized we take It happily is our competitors, that is may histopathology, transplanted population So one population. was because for for kind in and segment period. is intriguing one best a track you what post-transplant recall, very easy to does disease

be So is has But our the [indiscernible] take disease CXG a more a you should will a to Efficacy really hand, other in that the series for something real CMP. subcutaneous. to opportunity us than matter this advantages there really, from is differentiate what data right, or many really [indiscernible]. pill whether good is convenience, on in and or Valeant really

talked have [indiscernible] a profile been I want point we'll If indications is on out. the that we've combined stand and safety is compliance seen efficacy, the you and real of XX%. rate what to of that for PNH remarkable out, in other course, about always with used the this differentiation on market. also extraordinary has we've

SYFOVRE in the has hopefully, ingredient drug. will an new And see that we a Valeant, Aspaveli drug. is amazing and same active emergeor indication as

Operator

Stifel. the from with Annabel comes Samimy question of line next Our

Annabel Samimy

are that efficacy. happy something the on in My in to generally channel they we they spoke to guess that responding do consensus how their give to with comments we're these physicians physicians not is in that I SYFOVRE, it's line data is, that edge typically offices. microperimetry So among find our question your because checks,

that, this they So tools X-year right their adopt the how they their have patients patients tools And retention start to that, are of they patients with they ask And now? can XX starting keep over guess, motivated? off? these demonstrate so some patients Do can may to working. can that and time they use for show is where that frame beyond I them so time to dropping say, months practically benefit I

Cedric Francois

is Adam, going first. Annabel. you, Thank

Adam Townsend

Annabel. Thanks, Yes.

appreciate your I comments So on.

did are research to our We gap research. and market piece between in that our a competitor us perceptions a research and increasing we recent and there's efficacy also our in of market market sentiment noticed the

Caroline So my confirm to on what [indiscernible]. seems it said. I'll hand to over you

Caroline Baumal

they see time Adam. really showing that this the microperimetry in it you, and trend and the in data excited endpoint. over are prespecified them, that's Thank Physicians reaches data about microperimetry followed the

the with is most to that many shows real AI it testing, that a shown in benefit they appreciate using visual the algorithms has ways analogous world, microperimetry clinical field which combined realize in I and think OCT, benefits trial. But also that the like a physicians they to [indiscernible]. our use in

using in in clinical we've use physicians. I the and studies, and we ] will [ it prespecified show this that used this have very meaningful, to real cases we that although shown mostly people fact So endpoint to to date have to the patients, real are imaging world. In think world, micropromature though, it's highly be can we some

ASRS showed one the at the atrophy geographic [indiscernible] as treated to the grew patients much Xx we eye. compared in observed fact, In where

pocket cases was meaningful So [ in this like McCombe's video ] are highly ] and that Matt AFS. [

Operator

Oppenheimer. Next come from of François to going question with Brisebois line the is

FranÃ§ois Brisebois

was little the to the discussed, convenience understand or convenience not. correlation but of the and importance trying patient? of a to just advantageous if economic a convenience? on from it function understand that is so wondering, you here as the I Is have physician help to as and I'm the So value terms and economic just bit that can in we've value, us

Cedric Francois

to the pieces X you, convenience there's to and convenience Francois. the is then that is payer. quite the physician to Well, There patient, right? the convenience the to Thank question, frankly

patient really, with the start the we available every month other having convenience [indiscernible]. to when So dosing really, really is

huge I'm if of off-label that Our this other benefit every to has find there other cost will the We're competitor a get out in every into point [indiscernible] every going the their your it they use other aspect only way actually flexibility. think. The of Caroline should payer again some ] from amortized competitor, is is to meaningfully [ then view monthly. like on that differentiation we physicians year, with that the month the going ever and have label. our This ] is to sure, month advantage month And [ value. answer that we let of

Caroline Baumal

[indiscernible] it's certainly, weeks X to U.S., every And the I weeks benefits have plus/minus will Well, the and anti-VEGF and think of maintain to from our we've patients with realize very SYFOVRE, monthly more of in can this. certainly, difficult anatomic that X And come label, their is still realize really these know that that. X often in to that to patients XX likely to it's effects. dosing seen we Adam? And experience, dosing We dosage. cannot meaningful. for flexible complete X love that out with our come our every that XX drop month other to to complete because physicians days patients and meaningful very, in

Adam Townsend

Yes. Thanks.

are some that thrilled starting look we're SYFOVRE obviously, choice. category selecting prefer at this So and to payers

efficacy to going profile, its become it's us on good economically I really to robust particularly be for and simple, plan. this and this bigger. I this that's And continues increasing for monthly patients dosing. the and is And efficacious the with market other over time. is health think supportive is made month grow So was effects basically And for as think basically important decision SYFOVRE every right?

Cedric Francois

Some context want dosed to is everything, flexibility lesions that right? be patients aggressive with monthly. is there And the

very well. advantage to course. But from terms right? mean, I more there growth, We monthly, perspective, are of treating seen clearly monthly. as the an a have there advantages dosing GA reducing That intense of in it is lesion in is to

huge time. the amount we in flexibility, its that also So over absolute, both but that longitudinally of have, data

now. We years have X

We more will data coming. have

that's of incredibly valued. All

FranÃ§ois Brisebois

up just shortly just Valeant here. lastly data And on because Okay. it's the coming very

see understand primary. some here. in And on on in the the and trying to the success from is of of, secondary what need the terms trend all? this is just the on in on discussed positive guys expectations terms regulators this stat more Or [indiscernible] to or But sig You secondary, endpoints secondary conversations? endpoints

Cedric Francois

Yes.

trend The point. of end needs secondary endpoints supportive the to primary

have We is there [indiscernible], with we X for this believe endpoints met. all seen at things. you forward to data the endpoint. they Those the were recall, a are But primary where the were [indiscernible] X-month after year, may path asked of having where submit none still specifically secondary as

important the we to contextual, very measure but support of to primary Secondary endpoints endpoint with provide are the more [indiscernible]. what

Operator

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

Douglas Tsao

the most of of I were indicated the like might to of them versus I terms unbranded the just case. DTC been now I'm of then SYFOVRE curious switch of continues are done, in sort in DTC work I a part, the on I'm campaign XX% branded the come of [indiscernible]? competitive has of where Adam, effort sort on [ think focus campaign. and And specialists. treated, the be past, to the consider on Henry just attributes being the of curious, terms an Winkler retina you that you point books in ] had for patients that you think that have if that that the quote to in Phase Does dynamics you now already there a sort --

Adam Townsend

Thanks, Yes. Doug.

vast market already growing majority the of a patients and And approved current with large the for of regular a most specialists. obviously penetration were -- patients is books this those on of yes, market So XX% therapies. those

GA you this into the help refer ophthalmologists And X patients thing start perhaps our for seeing is to going And market [indiscernible] a and retina potentially really facilitating as educate to treatment. to critical. to will those We optometrists going us. specialist atrophy see once of plan big viable that on they DTC is that that of that super they a they're were education geographic physicians, to the it be is patients able actually So educate tapping part example. One of have other Phase are complications, had that also and we disease.

part patients, did branded education. physicians. Doug, Winkler but X of as So was DTC, yes, was incredibly to Henry ] [indiscernible]. transition We by also well received It [ by Phase [indiscernible] state

have about conversation the is on disease, eyes checked. benefits educated was And talking get to then and of us a the are the efficacy and SYFOVRE Henry that about and patients So branded so world [indiscernible]. that your DTC go they the doing SYFOVRE can educating that ask

moving we're with progress going Henry an exciting SYFOVRE As forward, actual there's a forward. on real some happening to strong things with we moving approach and push for,

Operator

comes question line Our of from Piper next Amin Biren with the Sandler.

Biren Amin

from Maybe dynamic. on competitive that a [ today if ] similar they're earlier treatment of I data? starts. Are [indiscernible] Astellas your start could the their with call, majority you seeing new use research stated trends market capturing patient seeing

Adam Townsend

Yes.

we which market through a a is use tracks set, that research, actually think data are data So into set into like and we our patient. not a physician vials -- then

I research, robustness we and So we in market think get the market you you but believe do when this, do of bias some could research.

it quarter was the strong of maintaining new starts. And the [ we share were With that's the I approximately considering the of headwinds think competitors have, XX% ] J-code. really, really still

being So total that's the And this how it. we product market look believe to the big market set. can of data very XX% a at and share of We be look is the number. in how robust GA market #X we future

Biren Amin

could terms if have data in And Great. of That's helpful point. then maybe a follow-up. I

on So grew about quarter-over-quarter. the seems it XX% units commercial quarter,

about samples, you sales grew If take quarter-over-quarter. out XX%

in for net lower the gross what should third we to quarter? And So expect is for gross from the the to remainder net quarter?

Timothy Sullivan

Thanks, Sure. Biren.

what numbers. accurate it did terms well it [ quarter. guide net It up those net, of don't to last don't ] are exactly that say gross within this for was slightly gross but in where really we So we the out, to of go then was more is. obviously, range the And numbers. quarter, the files And

Operator

going Suvannavejh question to the Mizuho Graig from last is our And line come with of Securities.

Graig Suvannavejh

fourth first commentary how provide the as I third I'm around on just and just on about now think earlier up revenue a us you're if got wondering comments you've can particular. around in quarter year just SYFOVRE anything, second wanted basis? modeling impacted you as and behind to quarter expecting, on the you, what impacts we follow quarter seasonality go-forward in seasonality any the in if that

Adam Townsend

question. the for Thanks Yes.

an to here. we So weeks A there. go of metric ago, are a proportion time ASRS physicians couple a retina important big obviously, like of is conference large measure seasonality right? Every to

add attending physicians there about So you retinas retina learning where from those Caroline, want your [indiscernible]? multiple be and are our efficacy meetings conferences anything will forward, data. to moving

Caroline Baumal

That the increasing time. some want to be a presentations. have going to patients retina physicians with that's are exciting upcoming product And really looking for, effective effects they we offer over

forward they So working to motivated analyzing data. on looking very us are with the and

Graig Suvannavejh

there Is anything And on picture? -- seasonally, patterns just Bigger follow-up. third purchasing anything quarter? quarter just as versus like a fourth

Unknown Executive

at I X don't experience market. and obviously, think stands we've nothing that least in can -- of had yet really be anything And terms months our really have that in mean, out that to in There's this [indiscernible]. say you I [indiscernible] particularly. enough over [indiscernible]. August

Operator

conference to over said, no remarks. And is would to further and I turn there the for further questions, as I Cedric any back like Francois

Cedric Francois

this you, Thank operator. for us everyone, morning. you, Thank joining

to feel Thank Meredith, forward follow-up have we to questions, out speaking many today. any you to please free with If look reach of hearing you. you and and

Operator

and call. you for disconnect. conference today's concludes now Thank may This you participating,

Apellis Pharmaceuticals (APLS) 1 Aug 242024 Q2 Earnings call transcript