APLS - Earnings call transcript Q3 2024 | Apellis Pharmaceuticals, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Apellis Pharmaceuticals Third Quarter 2024 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the call over to Meredith Kaya, Senior Vice President, Investor Relations and Strategic Finance. Please go ahead.

Meredith Kaya

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

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

Cedric. Now I'll turn the call over to

Cedric Francois

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

SYFOVRE past few Phase III presenting results the such our progress key of the with made meaningful valiant milestones targeting IC-MPGN. These reinforce and way and Empaveli power towards belief diseases. for to our is as the generating For the in data CX and we goals, treat optimal complement-mediated CX growth underscore reaching months, groundbreaking long-term continued CXG have demand the vail

During XX,XXX quarter, SYFOVRE leadership X% market by maintained to its for quarter-over-quarter with demand the SYFOVRE commercial vials and shipped physicians. third commercial grew vial

last Third more than period net million $XXX were quarter the same product SYFOVRE double revenue of year.

expectations, that shortly. to This declining recognized short Tim last to speak net and will gross X.X% revenue we adjustments, the fell to was relative to However, higher by due of quarter. partially which Adam

than demand quarterly quarters. Market adjustments performance API did sale an therefore, a SYFOVRE to clinical We'll gross more growth we our meaningful expect the the patients. longer slowing was GA [indiscernible] going of the nets to more of previous of take continue be pace typical but we quarter-over-quarter, overall To market. modest GA is forward need the retina to profile. often and support to Importantly, Also strong of quarter slower profile being driven appreciate going build next stable and complement to grow in decide this to affecting their model. group treatments building Total within now treat need by benefit risk growth time specialists. forward, with

path to ramp the irreversible and progression see significant reflect at signs long longer. are tremendous ratable disease new We accelerating on will XX% starts, impact our blindness expect results, near-term delivering patients' We these slowing for over the preserving an low term be forward. markets. Early patients potentially in are has conservative commercial GA the that the of our growth redemand aimed impact launch. estimate single-digit is the for our remember an to expectations are as for in revenue initiatives insight into those, new have initiatives. net launched to suggest strengthening on this, remain several but early diagnosed Considering important our that in anticipating into GA further quarter. We leadership still of half we and eye growth about we their visibility fourth key all seen coming we are by are market estimated the and GA the and that market being but market dynamics XXXX SYFOVRE treated. our patient percentage vision on going of in provide sales growth, to GA and We expectations efforts positive GA more opportunity remainder currently the share and of a take only impact of patients months growth growth value overall increasing the modest and XXXX time. the plan in the care an gain of professional. And SYFOVRE for It to stages

function. We spent to effective would year full and to once therapeutic do touching to because complement. results compared based on becoming last means Phase targeted the therapies therapeutic CHMP data. month. across that a positive the we and pleased further, multiple believe And on CXG on multiple FEMA Caroline as a discuss decades we have share particularly remain opinion showing remains targeting drug. have Apellis' week target further were VALIANT that CXG these to within [ I III X extremely IC-MPGN moving are FDA blockbuster treatment potential our CX were SYFOVRE week the diseases, and our These again, benefit in feedback to for geographic believe ] paradigm IC-MPGN. We from We CX Apellis, negative will analyses We time. the CXG these our file early VALIANT not PNH, to a Empaveli. of IC-MPGN. At for which CXG IC-MPGN as has believe atrophy redefining this NDA and study the the from preserve current despite other let plans that both investigating significant proposal the kidney now results targets patients last areas, the then best-in-class disappointed received Abertis for and suggest that with as we Empaveli we in continue results including track positive been next submission we last pursue Europe. rare accepted, X-month EU supplemental but kidney to to on CX at vital approval primary Quickly has Importantly, become track with in see treatment

require us Importantly, FDA to not file did with the full data. the XX-week

nephrology health and the in submission U.S. soon. Sobi, followed provide file are detail regulatory a unlocked XXXX, in XXXX EU also by to expects Japanese we ex effects. The early the opportunities VALIANT on partner, data Our plans later in to with evaluating submission authorities a within that additional

patients' U.S. meaningful compliance front, in well receiving. our same quarter, which the third products, making substantial in us has in future. closing, X% generated compared $XX.X as XX% the potential, benefit the On that In these difference to revenue the commercial fundamentals lives. strong are Empaveli already million up the with last X patients position product blockbuster each are supports for a in period year. The commercial Empaveli PNH rate

holds to pipeline soon. we look forward on this products, exciting emerging more and sharing Our

I our We discuss business. And clear core commercial path continue with a turn to our to activities. independently on can over believe profitability will Adam that, fund it are now to and to we

Adam Townsend

and injections will I of morning, in approximately doses, in quarter demand approximately half starts. XX,XXX defined In X% compared The everyone. growth third delivered begin leadership SYFOVRE. approximately the Cedric, we approaching commercial SYFOVRE. share to new the patient closed and with a as good seen samples XX% reaffirm SYFOVRE's market. increase third during quarter the quarter, the Thanks, and by with of X,XXX SYFOVRE market QX

awarded more X,XXX September, of SYFOVRE. care than As sites have of

demand offset by to affected that our increase net in As net, including gross adjustments overall to the was Cedric mentioned, contracting revenue.

made contracting As XXXX. practices end competitive decisions the with remain within physician quarter SYFOVRE's common the to strategic a impacted that third reminder, average space. At the in price of XXXX, is we or sales reimbursement of contracting ASP buy-and-bill

due also decisions this quarter to incremental rebates took X. higher some July that We effect on recorded contracting

While this quarter not to or was clear, particularly in we large discounts have be the do impacted, nor intend we chased deep future. to rebates

with long-term Our strategy of for and has competitive SYFOVRE offers. always recognize these preserving been balanced SYFOVRE to have staying maximize efficacy economics. We that the economics access patients importance the to while

demand. back to Turning

SYFOVRE's engaging new further SYFOVRE, moving data profile. We as help ophthalmologists real-world Phase shift tend X for a part GA strategy to that sustain We demand several unique the a do are profile optometrists injection reinforce we in SYFOVRE. generating key expanding proposition needle, that increasing to our on growth preservation to and new growth non-injecting even the there's initiatives end, encouraged general of commercial SYFOVRE's reinforce to analyses forward. To other younger the function continue by of we to so actively patients experience educate up over congresses benefits, reducing of launched clinical include dialogue non-syfovrial and towards user safety. Key specialists with more for initiatives the but easier evidence this such retina patients, and with value and multiple continued by robust and including treatment who new of the making to higher payers efficacy injection patients, know force, ECPs clinical with strong forums engagement we've SYFOVRE's seek our effects to with to work demonstrating time with treat specialist, ECPs visual medical well-documented as share introduced XX% leveraging

to early indications some positive We see are momentum. of already pleased

seeing slight last the decline in after in of quarter, rebounded half share SYFOVRE QX, example, of new the For a start quarter patient closing at the the XX%. approaching

up are Medicare plans Advantage leading SYFOVRE last This made Additionally, lastly, as market X, messages only recently adds shows plan in the in January effective from appellate efficacy place on as their product XX% efficacy April their from in on SYFOVRE's commercial national July. only product to resonating, their research PBMs to preferred surveyed formulary, the large interaction, preferred discussion XXXX. the a the ECPs September. And recall X large SYFOVRE topic that the XX%

our brings profile patient campaign DTC Looking ECPs. ahead, on we suit, to This awareness Winkler. plan SYFOVRE's to launch X of branded driving back patients and which is conversations increasing with educate campaign intended spore Henry Phase

an stable weeks uptick in initiatives impact. has share have recent patient market combined at are since XX% in to been new roughly SYFOVRE's This, the September. starting with our suggest share that

it that benefits least offered more for encouraged delay positive That questions XXXX. Market must the shows which benefits be patients. safety to that messages traction the for While at are resonate. take truly the conversations the gain in It soy of our those efficacy to continue an remains long-term time our and still why momentum, remainder are outlook X these SYFOVRE meaningful discussions is guidance will to by strong. with can prudent ECP take we before about we research for of said, about

potential, the gradual, only only a X SYFOVRE's for a with growth market new therapies further forward is opportunity scratched least next moving years. surface in will available anticipate large the category growth. We have no and be competition there for of at We expected X significant but and

confident the leading for many years product GA We will U.S. come. to are the in SYFOVRE remain

in treatment from physicians with in use for Empaveli are and We the I'm proportion resoundingly enthusiasm approximately efficacious diseases under diagnosed are the a of We most available. compounds believe Empaveli we is that development exceeding in physicians SYFOVRE, approved, opportunity opportunity Beyond severity also expectations. If of significantly available. Feedback this the expand believe no for IC-MPGN. is are has of among that position that about data highest the these into strong Empaveli. CXG currently differentiated the even other there growth Nephrologist X,XXX commercial a these from significant. option capture warrants Across excited meaningful market to feedback positive we likely for because indications the believe but diseases to significant patients our been the estimate U.S., these are board, treatments and generate

remained rates shift third million Compliance $XX.X consistent the In Empaveli's me remains high let in now Caroline. previous XX%, approximately that, to and PNH. at U.S. profile our over generated to will the the with Now updates. product turn net Caroline? safety With Empaveli I quarter, call revenues.

Caroline Baumal

morning, good and everyone. Adam, Thanks,

As instances us published soon. real-world we to a reaffirming adding unprecedented efficacy are expect see meaningful and supporting reinforce body to SYFOVRE to multiple further third SYFOVRE party be of our real-world SYFOVRE's Adam to the on starting evidence of robust around mentioned, paper from the SYFOVRE's treatment effects first allowing message we These efficacy. strengthen data presentations, largest and

and was on to EGFR feedback Week evaluating disease of treatment. are Valeant data that a In focused potential the These physicians markers last Empaveli. these presented when remarkable. diseases, key month CXc Moving was full at The activity Kidney are on propria, staining. X set

full pegcetacoplan our just effects key treated significant pegcetacoplan intensity, all week data and is reductions statistically eGFR, consistent in proteinuria as the CXG of X outcomes X patients significantly for from of CXc efficacy no CXG age early X As observed status. A shows subgroups effects extremely clearance in patients totality all showed rapidly, of patients of these reduction with with consistently and detailed type, approved or staining included in and were CXc are in a that The XX% a months. This IC-MPGN stabilization as IC-MPGN. of regardless complete transplant deposits. There disease treatments pegcetacoplan of achieved substantial reduction of improved set, the unmet staining and on need, function across of with having over data and X key that diseases a indicating Valeant given positive for measure XX% the high. CXc severity disease and

patients, We everyone are and communities. within the else the mean physicians, for about results IC-MPGN caregivers ecstatic the CXG and what

earlier-stage in pipeline CX our currently Finally, we Phase are to continuing advance development as siRNA our such I our and beam is that collaboration.

review the future. share now turn of over call you for the to excited our are more We to programs Tim about details financials. pipeline a in with I will the Tim?

Timothy Sullivan

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

release Total $XX.X million this Empaveli we XXXX. XXXX of issued available $XXX for earlier press approximately revenue. This million of morning. including was compares in product third are net million, that in quarter million with revenue quarter $XXX revenue $XXX the sizeable in and details in the Additional total the REIT in third U.S.

Turning to rest the of P&L. the

sales For million. Cash of reported stock-based were were which the for third expenses was third $XX.X operating approximately cost $XX.X were amortization expenses, and million. expenses we R&D loss million excludes depreciation of million, net $XXX $XX.X quarter, the million. SG&A compensation and $XXX quarter. and a

cash cash expenses our R&D expenses XXXX. of in in to and operating SG&A We inclusive expenses total than continue to XXXX, be expect total less

of a to As net quarter was SYFOVRE's Adam as factors. in percentage our result mentioned, is compared this there an previous gross to This X quarters. increase

resulting to contract discounts in first higher due The decisions to physicians. was

true-up The QX. from to second a certain to included prior net related in quarters fees gross of was in

expect we ASP and to net mid-XX% to of continue equivalents in to modest confident strong With low to but September by contracting, third expect in range. through the million not we erosion we impacted that gross cash and our be cash be remain the to expect quarter. ahead, as rate saw erosion XX, gross now and we XXXX in We position. be to Looking in at financial the to net $XXX

call sufficient Cedric? sales cash existing over closing business combined remarks. hand our expect core for our We fund to cash, Cedric I to positive future our will with now product the be flow. to to back

Cedric Francois

you, Thank Ted.

building GA session. we front support on in and business, confident a opportunity pipeline CXG for to to position commercial markets blockbuster of to programs that, IC-MPGN. us the With in are products, in focused the X realizing out over in are We go to the our will the shareholders. ability With potentially our financial development now value and our innovative and and of Q&A we patients create continue strong significant a

Operator

[Operator Instructions]

will John of question Miller first Our be Evercore. coming from

Jonathan Miller

would from question market about well, in talking in mind, here. market to Obviously, and spend my XQ talking their expectations and of share beyond? continuing competitor their I love the we increased one heard dominance all evolution XQ about in share for your

versus taking physician retina So do to that into extent the view market going them what are pushes offices. drive dominant what are end to patients those deliver you you competitor? think And the ophthalmology who's on going share. what actions the do and the with pulls to those you're to up how patients to the To to extent opposed practice, as

Cedric Francois

Thank you, Jon.

will out That month the its benefit over as has increasing the patients. that It look, shown said, we profile, in time both really efficacy in dosing that on every what and differentiated other profile only drug the efficacy and efficacy So has shown with always also subfoveal what of SYFOVRE's differentiated stands we've right? life foveal effects be is now. building market is

thoughts. a to I'll couple of over add you Adam, hand to So it

Adam Townsend

John. Thanks, Yes.

we're believe think versus really launch, patients. calculates now obviously, injections based the our similar on metric, that way a this into believe heading the So to XX%. we're We share it's market based competitor calculating are of we of important actually share on and we market as at share. market year We is a X

frequency, XX%. we and incorporates And we use approximately to valuable share be that were it's market really metric. if Injection why based active think usage, dosing our patients. on as share would bilateral as still reported, factors previously a That's patients, have compliance we such Now market share

believe XX%. last the starts decline the after new seeing plan and have strongest Now as this half we And and that new start SYFOVRE, prescribers quarter, the slight executing we're QX, in we patient profile, is closing efficacy-driven at bring prescribers reason market, of an market. we quarter efficacy the starts, the the into and young patient is of our to new the per approaching in rebounded a

Cedric Francois

answer So that your does question?

Jonathan Miller

Yes, that helps.

Operator

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

Tazeen Ahmad

I this maybe And SYFOVRE. to on wanted topic stay

been their cadence at upward. about it of providing appellate launch, I provide think to of that to and the going feel stab a people had Your seems call guidance providing revising comfortable last lot at competitor think has know of rate a investors how a It I detail the then running. first sales. tied growth market is of be. on to guidance question when would also you think And their that's is the

I currently think there's about of the questions the some with GA size products approved. X

year of about let's comfort be reflected provide, sales in full on that's So on size feeling what about the need going that go-forward thinking guide opportunity? say, a you are the how to basis? how you to you're you are And thinking overall order

Timothy Sullivan

Tazeen. providing we company on and year, next for decision made you, a guidance of that Thank haven't things. we're Look, considering A yet.

initiatives And market fortifying a out once leader like that sort there growing of comfortable We I have it's guidance. right how we some certain to think we will as feel better at for little dynamics GA position feel point, think on settle now, market would moment I that, our we've we have overall. these over the But discussed, time. bit this of we see and We'd under in focused we're are consideration. evolve. But those the market the understanding getting think

Operator

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

Anupam Rama

docs of sort think get you is in trends And should any rightsized to inhibitor. that of kind that complement terms tier you next tier to and physicians disclosed in talking team for a prescribing your SYFOVRE Do XQ? we sampling that about of of about of terms to sales what in think relative you're next of

Adam Townsend

it's Anupam, Adam.

breadth at And right believe we our grow the analyze a the moment, execute the regular have on and depth that field team to market. across a a audience. and force our target structure our infrastructure sales based strategy on we and So basis we

new couple made to drive more and initiatives patient of a patients referrals. We have

to So patients in process we retina non-injecting users. to in have on team and spore help physicians. atrophy fuel we ophthalmology the of to more also injecting putting refer a an are virtual team for ophthalmologists to more optometry also educate to digital field place referrals geographic And

of a make of As given and now it comes samples significant care. has And still buy-and-bill model, believe sites at we commercial forward. role approximately vial have up over X% coverage that to moment, the will a demand but sampling, believe file at with payer less commercial X,XXX code, moving growing we sampling is X%. have that we this that We SYFOVRE obviously, our well-established demand J

You this use of as would expect more SYFOVRE. get that new will more and part of prescribers samples as market. experience they

Operator

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

Salveen Richter

that could how market growth for this flat group I just group us of modest now growth large on And and noted these next is? by you revenue Can back XQ. go accounts help of the in what specialists you is to also to Could being if net? to specialists. are just gross understand retinal elaborate driven this terms You who that just just in

Cedric Francois

Thank the hand of will answer much, over part you the then question I Tim. first it salveen. to so and

is community, this think I just because type retina I the community of not and So any think the but launch. retina

enthusiastic movers. And retina wave You you have that have first kind innovations engage something you then a then wait that be dust approved well are to is slow for to the with slowly on have a settle for waiting wave the next of that doctors patients sidelines and to physicians the this in to swath progressing, the devastating down disease. have initial whole the first that where of of disease wave as that of as been

add and where to in what I Caroline, really marketplace. currently don't we if that's are So to are the we something this? know want you seeing

Caroline Baumal

Sure.

been younger a that retina limited for think I time. and trainees also only practice have doctors in many

the maybe how and on treat patients, to of have full about effects these but geographic learn their they're not patients. geographic motivated So seeing very, very accuracy atrophy to

and we retina physicians they So young don't and we these training in to more have SYFOVRE. available really would new that that with like of to sure trainees any more make forget

Anupam Rama

will incorporates XXXX, that gross was gross going mid XXs. the mentioned of forward in I the our that prepared through we to which be guidance, terms believe the net low to remarks, in In net to that

Timothy Sullivan

large third a Obviously, that function in relatively we this this to all had quarter, together jump. a gross That's quarter. came launch of dynamics net certain

rods expect gross as a don't remotely of anything as to going we discussed. So in forward. more we sense to net this in evolve ASP And modest a like sort steadily

Operator

Nochomovitz question Citigroup. next from Yigal of come Our will

Yigal Nochomovitz

So I question, question. ask I'll for guess my X-part one a

curious you just was a on contract maybe the the more clarify in patients could to provide Just persistence on ASP? up And in of have or in lined if something of the trigger related therapy. volume the that. percent impact and there quarter, collected break on that any staying may just to data I'm all It you've order related Adam percent don't if of duration a taking of therapy then the that to the be return a may that discount this little regarding terms third like are then the clarity could you sounds schedule?

Timothy Sullivan

So part your sure. I question. the Thanks, of start Yigal. gross with will connect

was quarter just of remarks, the storm dig third the we in into in parts. impact this mentioned sort X this first the ultimately quarter. things. divide in And this X know of perfect I I'll and really for a a prepared created X So but result

was we had made true-up piece, provided in is strategic ASP which that, insignificant prior the of quarter. within result that contracts X the that The is of parts quarters. and third certain in again, incremental QX, starting actually a okay? Beyond expenses which resulted first in contracting the as decisions and is, certain not a these rebates a final And fees we then one, from lower XXXX, late

now expect said, So to to as gross range. low the net in XXXX mid-XX% I to through we be

Adam Townsend

Gal, Adam. it's

dips. on question You also asked a

drives with we're that A the other of moment, and on are the is flexibility patient similar discontinuation really provides from the with strong [indiscernible]. feedback physicians seeing compliance every obviously, you in committed efficacy to patients these is see dosing. month those motivation, to believe other seen dosing staying anti-VEGF also their patient monthly Every on driver adherence, rates preserve also we and key persistence So what compliance patients, with we're with drug the meaningful at happy vision. to to

Operator

Our next Raymond Seedhouse question of will be James. coming from Steve

Nicholas Econom

for on is This Steve. Nick

Just one further quick up clinical you kidney? you in us. for line? a indications when renal for which comment line a Are like time development able on you Or to articulate do for do testing you have

Cedric Francois

working yet, short we But answer. not of we're hard the will couple clarity. in So next months, more provide

Operator

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

Philip Nadeau

impact going street One is forward, where prescriber from EA. in follow-up of then was then gross very net there's Tim, going. database you've net entirely on on QX? of and reports. the was Could And one what question feedback gross feet actual from for still us. Has terms the the [indiscernible] not I'm the been been event actually quantify any reports your vascular get market in seen? adverse clear in what from in those that to you've some your had clear Curious QX. you at where eyes on in gross on

Timothy Sullivan

Thank you, Phil. Yes.

net in what And the there. the guided high range. we beginning to probably I'm And give end as accuracy all were east had of perfect previously in we in of of earlier of kind we about terms that. of So that that's the of we had to XX% quarter, this going of to described on, at from because of been storm, the the sort middle And XX% launch the gross range.

Cedric Francois

And then -- that? you a sorry. Phil, to had follow-up

Philip Nadeau

that's helpful. saying very just No, no, was I

Cedric Francois

But to the stands that mentioned the competitors' believe difference head we that, as the comment going so efficacy on is not we earlier, we're safety. on we relate where ans between shoulders. again, our products only As out X SYFOVRE profile to real

effects in our only and with and increasing included both set. fulfill data dosing other every time We have month patients product the the -- we with are over SYFOVRE with

Operator

And Jefferies. our from next coming Akash Tewari of question will be

Unknown Analyst

for This increase is of million Kathy like associated seems [indiscernible] on is million. on [indiscernible] for your efforts SG&A in an X months spending for with $XXX with sales of spend Akash. of promotional It competitor $XXX

your on approval, the period So what of around term, SYFOVRE's during was ROI launch, what so investment? And X are return a in year similar the time then like levels long your DTC And different do it XXXX, in already? this targeting? this year much spend will think investing since year specifically for in you're more spend the DTC from be you're you for

Timothy Sullivan

Yes.

I'll start and thank I'll So over you. it turn Adam. to quickly out,

break really finance specifically So -- hand-in-hand we spending on work or Obviously, actually constrained the those be really haven't like like ROI. we're efforts, those And turn for what Adam. possible efficient with Adam commercial out just to answer, we as on we don't as hasn't exactly it metrics based we've to tried amounts. as And on IORT over group that things I'll

Adam Townsend

Thanks, Kathy. Yes.

So we perspective. every initiative ROI at an from look

patients take and drives ROI in. on it cadence on many, many Henry initiative analyze a sophisticated Winkler. we do state us, monthly internally with that's that, So believe it We pivoting regular actually that. more to and robust a for DTC really, a big disease like education We a analysis sound really approach business

very for DTC. it's ROI positive So a

type really scratch we've market, and really, is the surface. we This the only that's just of So to analysis a big do. started

ROI looks what perspective, the effective and results plan that our better are So the will be. more like balancing an executing we in from the

Operator

Eli be will UBS. question MerlMerrell from next Our coming

Eliana Merle

little a more trends to volume about you're want seeing. that bit the talk I

expect ramp So gradual forward. more that you sales going you specifically, the said be to

trends of terms October? that vial details shift, far more in Just similar expect volume vial we XQ And you're QX? on the give any does mean so you just can growth seeing should us as in in in

Timothy Sullivan

percentages is sort think right? we for planning in guidance we mid to to of vial So that low the I mid that So I did give we're percentage on said vial quarter. the think roughly growth, think and some on don't what expect, remarks prepared the growth, I that, guidance beyond

Operator

Annabel of Stifel. Our Samimy next come question will from

Annabel Samimy

patient of or for Or or into typically optometrist, initial the low-hanging mode? And and patients as less waiting dynamic in a of you then fruit. specialist bigger the ophthalmologist got are from terms -- severe because worse specialists Does dynamic they watchful from a be monitoring they you are an they And guess to come there it's the those early I the starting when more. to a wasn't the there from push to I in in So coming you've who types that to in comes the this understand treat? seeing to from a are from looks optometrists little X ophthalmologists get lot Like what -- referrals? enough adopter. may launch, convert just of still these get specialists retinal it conversations mentioned those retinal the now of now What treatment? a severe? group? like see wanted patients from Are you're

Cedric Francois

Thank you, Annabel.

can I knowing good know on what the we So question, something of really great available the lot in to, where months to. us, kind forward that's to that but to we're slowly going want think kind you So data situation from our the if Caroline, That to efficacy, Caroline of And is something actually don't trials, patients treatment. physicians right? uncertainties, in a a and is real last that's that et states was as -- people from The how cetera. a of think good. up now not from educated look both about alluded really and think year also decision to an that? kind to to of where right? So a next with about important end really the that few make I looks add world safety, very data how dissipating,

Meredith Kaya

types patients. with is of coming later who And a action, the are and disease patients many of whether of I host add macular a into there's still me office. and and from we the there novel it's can colleagues myself. seeing We're always stages mechanism whole different are seeing who what I'm or what referred are paradigm. new have degeneration telling patients a early Sure. all of of my treatment still having patients This types, have

with I think efficacy. really that physicians they and center are having conversations patients their around

whenever needle thing dosing treatment a the course, efficacy I a then also long-term of role, data. by that a Now we have robust year. And have a other physicians driven of flexibility the are and we lot patients the with injections for really Safety X but think plays is of moves

full patients In Gale, X addition treatment. had of to already where have years

X physicians. studies ways, more are to real-world GARLAS done study. a to Apellis. And speaks real-world unrelated really, We there then that have in And many

robust and of of ahead, photoreceptor studies the data. preservation things so we XX,XXX confirming all has in found, adam. that have growth, just patients, reductions Go those have One those GA studies lesion over our and shown

Adam Townsend

of on the part question. Annabel, your just final

educating are like. also patient about so they their aware and could the that what and a as look progress optometrists is possibly we treatment to So ophthalmologists retina physician disease

actually new find are learning educated takes patients patients and want are for the lot "I a activity." get drug to hearing physician of X X and these benefit saying, type with in risk fields on Henry the SYFOVRE. Winkler the the and conversations it are disease. We the go between to We from about So a that that efficacy board

of physicians continue we'll the flawlessly as getting with can. have and we capability execute to time these as problem, we is So access a not

Operator

Our next question will be Brisebois coming from of Francois Oppenheimer.

Unknown Analyst

is for on This Dan Frank.

in color that? you Just us give terms recent touched a sorry you uptick new that recent in I'm quick uptick. contributed around could may the one factors to have if but the any what weeks, Anything this, on from us. of in patients

Adam Townsend

XX and did we're Yes. we been uptick ], [ continue and that XX%. approximately back has below we're below at Yes, stable dip And we stable. and

I and current I resonate starting all that that's experience. that the to our the targeting. efficacy us that while over And think significant prescriber with increasing these new on benefits flexible we're to down our effects think SYFOVRE dosing, but documents physicians of its time, also executing plan the base, bring, can it's real-world safety

can. as we will flawlessly So we continue as execute to

Operator

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

Douglas Tsao

aware if as in the terms on Maybe, color lost drive the had messaging weren't rate physicians Was rebound follow-up that. efficacy these simply you that the on of of I'm in Adam, of on some Perhaps, resonated impression in were they share? vasculitis provide Have to sort differentiation some and what just of points? events? focus mistaken of with of could really physicians under terms curious a a just it it? they

Adam Townsend

Yes. Great lot what of you've question, Doug. described. We did a see

non-subfoveal that we across can patients, and well-documented around safety. so So interactions them strong efficacy and flexible we in dosing get efficacy the field-based XX% interactions digital have our up to messages simplified

of We that's people fact well our our and as And what on behind to have safety. will base as been sure have our physicians very communicated understand make that to efficacy that we if transparent the safety the we don't stability perspective. continue the part from anything plan physician to know market. add want seeing hit. to that, the of I Caroline, what's think you in a I And to leading we're that

Caroline Baumal

Adam. you, Thank

another And is no by and them. we're rental confidence run that's take really they've physicians. very that organization think events. working the and we're unsuspected It's ASRS. that The RES physicians retina important thing I in their Committee aligned with the hasn't changed, rate organization. with that an And physicians seen is

play that's based come amongst real-world that really increased data confidence into right adopters. So the in has

Douglas Tsao

I was and sort corrected? factors guess just or mean, was was one that a all has gone I perhaps And, you follow-up, reps as of I out you've thought have in misunderstood there as that in Carolina, -- marketplace feedback And gotten between mean, you been mentioned. particular the your those

Adam Townsend

Yes, to on physicians the that from a them, data and hit is it bit Doug, resonate. incredibly take we've to positive efficacy. for driven going little knowledge on that believe be market we of this we've and once consistent been get efficacy a some them does that's we time messages And recall

think we is the changing efficacy curve. So

Operator

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

Unknown Analyst

questions you've quarter. seeing you're around trends fourth few also growth this had volume already and of like We've a for mid-single-digit It new the SYFOVRE. but the low to growth, in recovered October sort decent to morning you're sounds guiding patient

about commentary? just you talked that sort can full with trends of some those So October reconcile the of you've quarter

Cedric Francois

market We've slower growing, and the growing can see XX%. a obviously turn share out then what said start a patient the is of new -- bit is rate it just as approaching We I'll I'll quarter. see. over at we What still you was it also but a Listen, can to last little Sure. Adam. see, seen Adam in

think as like an short initiatives take dynamics I putting is quite have the of of right? We this quarter. talked efficacy place but we're in have immediate effect, certain Adam some the to So those DTC in and see will term impact we about, time that perspective described what dominate can But others over profile over strong from long these don't that term, we've take our the SYFOVRE confidence time. the

take it moderate want bio the say, just and approach low I look, if growth don't comment on that growth basis. to revenue was to to in you tried flat think mid-single-digit to basis a know I and more, Adam.

Adam Townsend

No, I well. you said think it really

Operator

coming question Fargo. of next Derek from be Archila will Our Wells

Derek Archila

as does for I And I just modest what the anticipating the imply XXXX of reaching beyond? side, in guess, flip wanted maybe type what funding of OpEx. while receivables I and of guess, another sale on to we SYFOVRE help So that cash I that some your profitability? comments current of strategy to to sales profitability reconciling flat levels just part with in, And squeeze should assume growth. then growth guess, on

Anupam Rama

That's you. Thank question. Sure. a great

quarter roughly cash. So in look, we about ended in of million with sale $XXX That included the $XX million a receivables.

was that obviously, the -- Q. you've So read

our a congratulations on roughly when on exclude expense $XX million our [indiscernible] million lines. of cash about line. And items OpEx R&D So look then of operating at you the the and cash that's on SG&A you $XXX basis, onetime COGS

interest get $XX beyond a on You cash to And fact had that of operating is basis. net we expenses that, around net to revenue neutral basically million. the we're

rest we monetize million the significantly months. capital. And looking put this little quite at receivables much as place extend and X relates you're in to that, usage ability sort bit X X for cash a earlier as $XX to working kind in our of operating this because months, burn So we receivables of these of to

from perspective, a bit bringing early. just that's cash that's our in little So ours really

pretty And around you see level, operating -- but can not are we if nearing, breakeven. an from much

and term growth have product, obviously, as this us talked to we've lot faith doesn't flow much positive. of long cash a So of it our make perspective And take about. we in the

CXG coming also on. have We

need So or perspective. see immediate we a capital risk from any don't

Operator

Our Biren next Piper Sandler. coming Amin will question from be of

Biren Amin

the maybe QX. that for what's increase they nephrology. person switches share talk for last of MPG? part you're about XXXX, force seeing that CX I mentioned that of IZERVAY from growth SG&A how you half Can And the have expect about you're as to many think should XXX-plus experiencing patient dedicated we new sales Novartis And the in

Adam Townsend

it's Adam. yes, Ben,

SYFOVRE. on first switching So

suggests but analysis data occur, we think that doesn't switching does So obviously, it our actually happen that frequently.

will to plan to and and accounts it what's our executing really needle that's forward. move the business. We We in the we're grow PNH new depth going obviously move on Hence, our to for think when young So prescribers to breadth bring into nephrology so now. the really work leverage indications, comes to but have we're a infrastructure from doing we small which kidney. that mighty infrastructure.

force would showing. So to population look there that that we're homework those doing at field compete the and to with is our profile we what patients to target need structure eBay get great the

Cedric Francois

maybe And that. X that or adding to things thing to one

there see that On will both the couple there's occurring in in a materialize of and mean this directions, field switches, right? still again, couple are directions. switches to both of I settle, months next in we as need things the

X-month meeting data scheduled and canceled reiterating fact it Washington but was asked were our because XX-month questions data, got not that the again, the of with to aspect submit other was is, all team meeting were as sufficient. We The the that a in IC-MPGN, answered. to CXG we pre-NDA relates had

very think add exciting program we meaningfully we to are what for So will again, doing. a that us

Operator

be will Walter RBC. question next of coming Lisa Our from

Lisa Walter

SYFOVRE the and the negative Canada, thinking on and ex about geographies, competitor from one countries, your any Australia, your of possibility potential also EU. And markets U.K., other there beyond opinion also on are just X Maybe of particularly filing and you radar? foreign the those How large approval the CHMP are U.S. that given Switzerland? withdrawing also recent are other

Adam Townsend

Yes. Lisa, it's Adam.

something Australia. guidance U.K., to -- are Canada with still obviously, that and the called that used consortium. countries of be Those this So within Switzerland, are we Access progress outside the

and with those to geographies. continue positive we So conversations have robust

We also is where move required. will forward in U.S. areas file the

we Brazil who And U.S. build a to help get in us is distributors regulatory get partner will other filing smaller for to those the interactions. we accepted. where started have infrastructure markets to lean to So ready with

outside So really large geographic U.S. of we atrophy see need a country. still it by we're country and the comes to unmet executing when

Operator

Scotiabank. from Our next of question coming Greg will Harrison be

Gregory Harrison

term? are color any Looking the positioning on from to they've you able longer feedback Are competitive time the your indications very you there. digest and had shorter additional provide to in now conference? And about at ASN, the positive thinking was in physician from some data the that how feedback those everything

Cedric Francois

that about you have, we ESN with question to The is transplant. you CX that, a your data right? we're opportunity much, point, to if on about for that so this really a I attend. never we was and that you being are worry very or to data you with reality have hemodialysis represents. about believe And something the have Greg. Thank mean teenager IC-MPGN conference requiring to excited an for asking that about. Thank what or Think the us the is pleasant here kidney, really

extends that about really competitively. So

that? As different staining also want a I effects you mentioned before, to on and reduction, but these importantly, to on we saw course, maybe X are of -- very CXc on EGFR on proteinuria where we something have important dramatic and. add profile we endpoints And stabilization Caroline,

Caroline Baumal

point thing I for board, effect was was important to as in effect the them wait to that And were right? it remarkable. age are the as young think I And in Well, really And about for that a their patients. patients clinicians the can our findings. sort in XXs. might of really across Sure. kidney as the irreversible, nephrology was is early my you. get X And weeks for why it that patients excited these Thank the often these this disease mean worse gets physician, to studies, first meeting. started worse, it's mean see say I one these get

quickly and having really that worked were to give them they them worked outcome. from negative a prevent and excited So could something

was everyone board, very the across for this. excited So

Operator

John of next our from will be Miller And Evercore. question coming

to question. next our forward Moving

Suvannavejh from will next question Greg be Mizuho of Our coming Securities.

Graig Suvannavejh

of perhaps term aspirational and question on inhibitor peak longer the your around complement potential penetration view My is class.

earlier XX%. long where term, longer But been might get You've at I take be penetration, granularity XX% providing you might said current go? about you you there? can about think how great do do on it And to believe think which

Cedric Francois

Thank Caroline? Greg. you,

Caroline Baumal

for these this for one are in, whether of it's getting that older. our cataract. no I think treatment. only comprised And be patients Well, AMD patients should And come

retina. is than We not optometrists just across have but provider so eye the optometrists, with much education market, that which do just more could we and care

So we the We're continue I continue have up. go chronic to disease. think just hopefully, really We'll penetration the start. that, the at will

Operator

Laura question Securities. Chico of will from be coming Wedbush Our next

Laura Chico

me. Two for clarifications

up on Just the guidance. cash following runway

Just contribution? wanted of per And changed it, the does CXG have a course launch injections here. to clarify, the but second, number that I think of then the average how that and revenue might missed incorporate over I patient, launch has

Timothy Sullivan

I'll take, that in Laura. incremental The be so absolutely obviously, would much, terms and massive very does. not are relative launch CXG you first Thank we -- the for It question. does. of cost absolutely where expenditure to

Adam Townsend

Laura, of it's question. the Adam, to second your part

other So push every Physicians to month every of efficacy flexibility flexibility SYFOVRE's dosing. in believe of other patients the month all month XX% dosing to to or and the that every prescriptions. of stable at has other XX% and really dosing, been

So we stay expect we move to forward. same as that the

Operator

be will Miller. next John from Our coming question

Jonathan Miller

data you considering proteinuria IC-MPGN ask How eventual kidney early do to relative differences you you design? in that expect indications. CXG, do obviously, transplant, -- discuss to to how expect post love you've on more expect label. going But trial to patient population materially little it's and in look Novartis' the you got for both a pre your the the given broader guys? to And differences label potential do I'd efficacy is be aside

Cedric Francois

Thank you, John.

in -- studied competitor your we only concentration, with CXG So all pre-transplant that in adults, But depletion. dose we to adults point, CXG had and we're on in CXG pediatric CX of and patients study, mean pre-transplant, only and what all our is to only label. IC-MPGN going that right? I patients levels transplant, the expect comment not

able data again, quality very same robustness VALIANT the where So it's to compared a able of the the we board, really we of to the population as the a to were we the reflection X-month establish. what studied and profile. And being sell narrow of across with what file in efficacy benefit

believe, offer to are transplant. And risk least in transplanters X,XXX of that this at parts which and that worry there of this treatment X,XXX to with relapsing. believe already to never to the a are have or X,XXX condition, So we at is patients, U.S. an possibility again, [indiscernible] we the in may about hemodialysis

and a indication we patients. tremendous important really these So believe for and solution line first all-encompassing

Operator

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

Cedric Francois

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

any forward feel you to If Thank free Meredith, with to so much. look you speaking follow-up of you contact many have questions, today. and we

Operator

you for your today's this Thank conference. And concludes participation.

disconnect. now You may

Apellis Pharmaceuticals (APLS) 5 Nov 242024 Q3 Earnings call transcript