- Earnings call transcript Q3 2022

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Operator

Good afternoon. My name is Chuck, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Amylyx Pharmaceuticals Third Quarter 2022 Earnings Conference Call. All participants will be in a listen-only mode. After today’s presentation, there will be an opportunity to ask questions. advised request. call be at being Please company’s the Instructions] that is this recorded [Operator now to would I like Ms. over to turn the conference of Communications. Lindsey Relations Head Allen, Investor and Please ma’am. go ahead,

Lindsey Allen

thank Financial With me Jim Commercial the to and Good Klee us and Josh Officer; Officer. Frates, on for Olinger, are quarter earnings. third and Co-CEOs; call today Margaret afternoon, XXXX discuss you Cohen our Chief Justin are our joining Chief our

make that of for we information made Before our historical make beliefs, everyone on or SEC. expressed recent and our of timing decisions are that provisions with I that and statement insurance ongoing policy to SEC Statements safe our and call this SG&A and trial, we forward-looking that RELYVRIO regulatory most presented our with may include made any commercialization from forward-looking any expectations, and be the the coverage, events as favorable. to results would revenue of this by in materially remind call including factors, ALBRIOZA. related regarding and of the future timing respect other the statements uncertainties and Private begin, implied XXXX. Expectations harbor most and on developments, to various with the facts statements filings from by result regarding to anticipated like Litigation differ risks, those completion set the we any during are and of could filings are other expectations current Securities and or are our to a Reform forth of decisions of ramp not in those anticipated recruitment pertinent access the whether Act plans our the will and and PHOENIX expectations expenses. Actual receipt coverage RELYVRIO Examples forward-looking plans statements of of based

on these disclaims forward-looking update any undue obligation cautioned to statements. to not reliance such any Amylyx statements. are You place And

will turn I to Justin. Now, the call over

Justin Klee

thank everyone joining and Lindsey, for you, call. the Thank you

community the Our launch few incredible United living months to diseases. neurodegenerative second RELYVRIO FDA And in following from commercial commercial with and every ALBRIOZA for quickly as remains, our And as end that marked possible. mission by and ALS the progress, are is in approval day of adults States. This on conditions suffering every We is ALBRIOZA can while who us. including ALS approval the the of RELYVRIO Canada. efficiently access person gain know working counting work much the past have help with benefit to caused can launch and we marks the ensure eligible

initial only a the early with ALS. launch the too with some pursuing people AMXXXXX shortly. the and are we share we we Given are of discuss in America, Union. with But Margaret engagement ALS will for are weeks encouraged is actively further the by regulatory expectations. treatment of living insights physicians U.S., specific the both North Outside to European into of in few it approval

by EMA. the Products Use, of review CHMP Committee or remains for Marketing Our the for under Authorization Application Medicinal Human

responses are the CHMP of which Report, the made a as Questions. reference Joint collects We now provided to XXX is as in Rapporteurs Day Day comments possession XXX of List applicants Assessment the to to

hold also of accordingly. some is the of Day Questions, respond we next to part as our next a from process The to our days the share an address in launch. to will Group objections process will The step major on some is several of call resolved and try the expect on Canadian that, have the first Issues, still into to turn With update MAA EMA still review decision we process. work regulatory review XXX to we remain, early year. track, provide half I’ll intends insights launch meeting List Margaret we continue part of Outstanding the to Scientific and XXX as United Advisory over in the Day process. and which While in of List the the CHMP the of to The to them the States,

Margaret Olinger

Right. receiving ALS physicians In support and we Thanks, have about and of are very following the on community positive the the level Justin. enrollments through prescriptions September immediately Care we weeks Team, Amylyx approval feedback in from RELYVRIO and the days the FDA’s heard providing. of XX, started

and sent with solid one was initial anticipated. feedback with the on Importantly, the forms excitement interest country, of earlier from encouraging clinicians one limited serving the not the to Amylyx regard to the throughout bolus, engaged are teams prescriptions living of community October initial In we of positive. RELYVRIO This specialty person group Team. widespread we and a than to an originally coming also enrollment physicians. shipment including products in from of been our ALS has number XX, into field pharmacies The seeing been Care a and country, RELYVRIO, have has across those or first the had geography

focused the and XXX all leading initially ALS with on engaged the of these since centers, actively centers already approval. are teams We are

help smaller on person to to access RELYVRIO. neurology We every with are and also has that centers living to dedicating ensure local ALS information and time practices

for which especially in can exception it person with is for payors take to to needed level a on standard will comment demand days the pleased both excitement, quickly ALS XX treatment how initial diseases. on launch, it, see orphan given cannot of fulfill revenue, new have get are to we yet medical translate into and the this to While the and any we people XX process, this product to

a gradual ramp-up As in commercial call we on outlined to expect result, approval continue a our as September.

with payors and general the living the have relates We’ve productive. managers, pharmacy major supportive to As of urgency with been robust of discussions to clinical to ALS. profile RELYVRIO’s had they access it benefit with our understood and people been working have majority conversations and insurers, in have provide

to [the coverage hard is encourage the given the broadest we believe working appropriate [ph]. are RELYVRIO educate the label] which and supporting data possible, We and

feedback days, policy receiving are year. at point. in early will good anticipate generally payors we to is We next of decisions it Although half the publish first begin this

Now, ALS across build be interest with our across country. community continues Canada. launch to the The ALBRIOZA turning month-over-month to in and the of to interest continues in national. wide The number prescribers spread

to are As it represent private one insurers, the relates private we insurer to approximately negotiations approval negotiation date, U.S. population. which have others with suit. closed expect and XX% largest call of September, access, we Canadian To as on our already announced in X in follow the the

public with will provinces of the about provide. territories currently the negotiations are scope and On in and side, breadth we the coverage they

wait. Our that families And team with have time to of we no their continue committed our and be to broad and criteria. goal living people to reaching knows equitable ALS reimbursement

to on We that ALBRIOZA significant have continue ALS. potential treatment the make to impact a and RELYVRIO of the believe strongly

we medical hear Our To at place progress and as from ALS, the our the financials call access and add teams I accessible I’ll to to more support closely person the you us partner community. to who more possible. to treatment want the providing review will gained. quarter and ALS with in as on close, to commercial our over and Jim affairs we that continue with is turn product, for important step, focus can insights will living and to appropriate With quarter. are Each every make benefit from our this are as through experience every that, launch

James Frates

reconvened Canada, particularly Margaret. the PDUFA we on results where from now were summarize Thanks, focused launching I’ll our our and the Advisory in September XX quarter, third Committee date.

product net of were September For $X.X ALBRIOZA Canada. XXXX, the the quarter related ended to million and revenues XX, in sales

to million million and million a development received elevated due will revenue for dynamic of manufacturing period the higher costs in a development to Canada given in to preparation in to the Research with by compared headcount this the activities expenses was takes support new revenue into that and thus quarter. or number to additional research expenses increase which to we for $XX.X the Selling percentage people X the were and ALBRIOZA, $XX.X to reimbursement the for preparation million related same compared for that the and XX expenses was and and small The same as near-term, of who are costs, initiatives, $XX.X XXXX. expenses revenue far, period were Phase since efforts. quarter, SG&A, readiness product in Although, not general only continue personnel we’ve by driven represented seen due expect time. received quarter. X strong were Cost of increase it It private to the for the quarter, of and for global $X.X at insurers also mainly and is activities additional by interest this to covered administrative the operations. support people hiring included associated headcount development sales launch launch majority and free, personnel-related to months, was driven meaningful support Canada and a $XX.X in XXXX. there commercialization. The This this trial translate PHOENIX do expenses, for process fourth primarily other commercialization our million

for expense the net SG&A $XX.X million, marketing our to period expenses U.S. a going quarter in and Net in we $XX.X loss growth part same some was the expect of additional XXXX. as for as sales We launch. million of forward, compared incur loss

Cash position. investments strong and XX, at were compared XXXX. million $XXX.X short-term a September at in we’re cash, for XX, June to As million $XXX.X

approximately not forma cash proceeds from had we closed basis, of XX the follow-on quarter net a million of stock $XXX.X roughly the on On investments $XXX short-term The pro balance does proceeds. and start October million in third offering QX. net recent reflect of at the we

ongoing call XXXX, resources as of RELYVRIO some Amylyx, This our the the We’re Europe all exciting for first With is over launch an us AMXXXXX in at the time. fund to in Canada, necessary I’ll that, U.S. the if in Josh and for capital time patients commercial to closing sufficient for deliver turn positioned with in remarks. to we our well launches U.S. is and and approved.

Josh Cohen

our Thanks, in PHOENIX Jim. Europe and trial. currently on status I well, enrolling is update wanted PHOENIX brief to provide on schedule. X a progressing Phase

We with late-XXXX. for into mid- recruit adults with approximately the continue to expect ALS to trial XXX data top-line to PHOENIX planned

thank are a team forward at PHOENIX look the continue to to our close, to here on To Amylyx. want I trial. take moment from track and this with to We results

about seeing excited are interest that into weeks initial only the We of are a we couple launch. strong

that have team efficiently person as on We access and look benefit to you dedicated will can who from forward this. is keeping quickly progress. our goal RELYVRIO eligible our to as and entirely possible, Our every all updated is

your we in the support. difference We Thank for looking call Operator, people and for you Q&A. the Amylyx, the motivated with joining at community, to even to a questions. lives are every make open ALS. welcome opportunities day us Here of please by for greater and living

Operator

We will the will [Operator ahead. Goldman now session. Sachs. question begin with come from question-and-answer go Jenkins first And the Instructions] Please Corinne

Corinne Jenkins

afternoon, Good everyone. Yes.

my from data? you the And headset Day detail those that are kinds that seemed with funky. of maybe how Can you XXX just able Questions List got questions provide a on your you’ll are of existing to Sorry, the little outstanding the confident be you address of from questions EMA? then any set

Justin Klee

Corinne. question, great Yeah,

job Tammy to you study is, that come Global behind and this. know, team generally Regulatory, Head can the has Head in that we an review we [ph], who to first What and provide we through a one we’ve X and an everything say through as is has of doing been we’re we every as regulatory don’t go We’ve of package, So, have confidence be brought But, probably our there questions Regulatory run. on a which well. course, decision. like of that data regulatory People Europe, granular us have we to who’s approvals of that. add already receiving named the Sarnelli, fantastic approval, approvals. may as aware excellent our excellent and of And have in to process processes. X regulator through initial only our support details lot I also I’d studies Dion

it. through working we’re So,

the too lot confidence a much we be. our final course, to know it’s early the data. think have of But, present ability to our data I decision what will and in of

Corinne Jenkins

normalize? to the we Thanks. the That’s think that assistance all how program? how but mentioned U.S., for about patient we I getting cadence the expect should you patients then with quickly respect to in today are helpful. do drug, launch ongoing free think that And

Margaret Olinger

that solid channel, the did see initial started today bolus getting I we’re So, Care are through and U.S. not that to a patients starting that now we We’ve Amylyx Team to drugs our mention in product initial the of see demand – on have just free not very versus to any are from PAP giving or naïve will say right few physicians across the but now, those we’re now. or I country. patients right clinical patients, as patients not PAP going And, whether IAP data patients there’s

Corinne Jenkins

Okay. Thank you.

Operator

The ISI. Please come Umer will Raffat with next go question from Evercore ahead.

Michael DiFiore

to market patients enrolled follow-up. one U.S. enrolled who in QX is general? of and Medicaid? Couple number progress. than question, for taking this Hi, Omer. respect you in say occur And you congrats I are that ALS patient sooner when them many the Mike me. sales updates? for in DiFiore Thanks with One, rather this providing my in all Will the and much broader RELYVRIO, and/or how Medicare split receive later? for currently have the versus does commercial so And will reflect guidance are insurance And in would on start

James Frates

I’ll Mike, coverage it’s see that channel. maybe address from in it’s the you And with But, Margaret, days Thanks Hey, start having questions. so we drug the really that. we’re XX Yeah. insurance for can far. Jim.

So give stage, to all coverage it’s a verification. the insurance that’s process days get guidance take hard XX XX to going insurance to at average through right, on to in and this

from know projecting we’re again think, of talk to more we us of we’ll we projections. very our going to sit QX. we we And get after little you’ve you start and we that heard the a want to when any expect start trends we of the bit where I to – that we as belt our response. experience thing I So call today see, So, understand, we’re each as under today, is on lot make give have right? said a the with happy But, before trends that sure

Margaret Olinger

Yeah. to And on maybe second question. just follow-up your

exactly commercial the a It’s So would see patients XX% Amylyx funnel to that breakdown the in into payor reminder, trend and which in the too is Team. But our XX% I early are we U.S., commercial expect what Medicare. be actually roughly that Care just know as Medicare. of the mix to national coming versus

Michael DiFiore

question, in untreated you. the U.S., Great. taking addressable patients market Or currently that That’s addressable prevalence RELYVRIO pool? every do roughly expand it terms into market? you foresee of very the X,XXX by as And of could the last the helpful. are total total in Thank the penetrating Riluzole more month

Margaret Olinger

be as feel XX,XXX Yeah, added and U.S. definitely so target therapy, patients that’s And we the on products to believe tried certainly to the have for be product like strategy of every really goal to were trial. is treatment. that And on. prevalent become number or patients, our all treatment there’s we on RELYVRIO. them And, in we’ve penetrate. and of getting And combination foundational of their intent do added every to give ultimately, in think certainly from around We is these other mission. will whatever in the I’m shot care RELYVRIO I’m of going on CENTAUR physicians we that to one add to physicians heard that on top top RELYVRIO it’s they’re standard

Michael DiFiore

Great. Thanks much. so

Operator

will Goodman with question from go Please next The come SVB. Marc ahead.

Marc Goodman

respect just how X question I’m you Thanks. these that RADICAVA, anything have First, willing there you you’re launch and just patients stay that to pay for any what model? you And for if oral, the on long Is you’re expect long product markets new it changed? payors the I are second modeling any Is in curious perfectly Is do to a impact the to that? just is how Yes. both? of on products with way of hearing. And kind then some drugs there your your well? is there? seeing doing how launch curious, out questions that there. other are Like, long obviously, with

Josh Cohen

Yeah. Good question.

products, with on able that on given is ballpark it in time specific relates well. to as That function therapy or for a – on really on product. year about done of education on benefits time I patient be research when So, said, support see probably we of we’ll on we’ve can past as But one the our robust median. haven’t the and mostly of having our we therapy, staying being where educate average to to some a guidance hopes Riluzole, therapy say

in our one Edaravone will oral confident relates the we that to goals. So have, we’ve launch, And, certainly think, and be the it of the we’re we’ve education very the relationships data as done I the built, market. in

confidence any add on lot in know sit, have you think, as So, we to insights want Jim we a if, that? of other said. where I But, Margaret, I don’t

Margaret Olinger

add-on is in label, to excited our that their just patients. that’s to or on that many IV. for heard out want of data Pharma, ALS. the of from from physicians patients those offer think there most patients we’ve about could are what I is don’t standard public and how their switching our And launch. currently to information it of They’re roughly Again, terms and then X there’s patients with No. care living of into know What MT communicated months they we naïve oral X,XXX Radicava, X versus about what

something that’s we proceed to continue launch. through assess So the we’ll as

Marc Goodman

clear, discussions And combo. who be just understand issue be to The an payors’ that physicians, you’re it’s not with to combo. respect the to going want having, I

Margaret Olinger

coming not It’s up.

on know, on roughly were our reviewing top We’re as trial over of therapy. our clearly And, clinical which oral of patients of data, XX% Edaravone. Riluzole standard studied was and care you

going there as an now But to policy. continue on there. of it’s a and together added start that keep eye now. Right clearly put big were it’s public to we our we’re a payors to So not, education on part

Marc Goodman

Thanks.

Operator

Bitritto-Garg Neena Ms. with Citi. from come go will question ahead. next The Please

Neena Bitritto-Garg

guys. Hey,

for question. Thanks my that. about taking Sorry

that on us the more whether Can patients reflective are in an was that ask just So that number mostly just you Canada. or any build? number inventory Thanks. of wanted drugs? was revenue color reported Or that not about to whether on was actually I the give of

James Frates

Neena, Yeah. it’s Jim. Hey,

that getting that you paid for can all again, the are getting fairly the are that not of by based think or the I number are up in revenue it so that of patients say reflective that’s patients covered. – that are the drugs. cover on the no given the patients the it takes of But, insurance insurers Canada, the But, that number of – to on time there. length that reflects drug

Justin Klee

just to to And, Neena, commercial Those we just months to take in yeah, say, standard as will Canada. to broad are XX from X availability that timelines. I’d it say believe continue of well, the get sort reimbursement

Josh Cohen

And maybe channel the is of end the launch we in other product reminder July, of only August. just about Canada didn’t start that until have and

So revenue that’s in an that well. aspect as number

Neena Bitritto-Garg

talk you’re And are Got a a timeline receiving reimbursement? get to in for little how can you about in to them it U.S. for patients reimbursed the guiding long drug took Was it. then, what it the that Canada? to also like bit similar

Margaret Olinger

the really private there we that It’s early to as to too answer the that that question, pay secure commercial moving over. are are patients moving insurers because on

ramp-up, really as it’s get more payors private on certainly see slow additional the and hope we that. a So to of we board,

very a Canada. it’s the U.S. payor in landscape different So and

analogue can don’t So that think it’s use for really I that. an we

Justin Klee

until end end as of pointed the very drug of important also – July. that’s the we Yeah, well. as contract the signed out, quarter the happen that till not didn’t The insurance was Josh available

that try in actual people I late So unique timing, use know got and ball, very of we the a look – but revenues Canadian also launch single really where the as crystal reimbursement a to – timing it’s it’s quarter the want very insurer. and to the and in specific a from at

Canada, year, to play. early lot and XX July to kind see late more comes from work the we’ll of a months So come fruition next where the that to into in X launch more do into

Neena Bitritto-Garg

you Thank it. Got

Justin Klee

You’re welcome.

Operator

next come from with Ghosh Please Ananda The question will go ahead. H.C. Wainwright.

Ananda Ghosh

prioritize was about the Calpain-X, do I my reference the that pipeline? was of taking and And indication? for you should next thanks of the more the Ananda importantly, Fein. saw I think on focused wondering, Hi, we behalf how future Andrew how there question. neurodegeneration I’m

Justin Klee

questions. great Yeah,

a knockdown, results. well share developed oligonucleotides So, I data data think, some Calpain weeks at ago on a potent other in-house. Annual the Conference, showed in NEALS were as couple as vitro we of happy to we’ve And some that antisense that

and a purely time. However, I is, of a one, squarely just early this that on launch kind is at as and working what’s is focus our stage company this think we’ve very important started on, product

So to that’s and we’re we’ll launch. to grow the all excellent continue think continuing evaluate having by enabled pipeline, how about I an think but

right work And the And believe has the And so enabled a I’d where priority evaluating, we additional focus But we and eyes, of potential. at be and to we’ve which that top diseases – continue launch. AMXXXXX and is do successful indication for to the exciting our have now are the that side, neurodegenerative hard I similar say And that’s now. by clinical been on our have highest things diseases. RELYVRIO, are kind us will those and really right scientific again, think potential launch.

Ananda Ghosh

Thanks. Okay.

Operator

to concludes question-and-answer back to over this Mr. would I the conference our like at This time. session turn

for closing Please Klee, go any ahead. Justin remarks.

Justin Klee

you, Great, us the today. for and everyone, thank on call joining

wanted by date. saying, to we’re of what Just our conclude has really accomplished team proud well, to

the all think ALS is I work us. that day. remarkable in community think remains, we for I quarter working every a Much feel and this really

that and as as from We possible. will their RELYVRIO on eligible know with ensuring quickly to no every wait. is focus ALS can Our have person, benefit have people families who and time efficiently access

hope So all a have you good for you and us night. joining thank

Operator

conference for presentation. The Thank attending now has you concluded. today’s

may now You disconnect.

Amylyx Pharmaceuticals (AMLX) 13 Nov 222022 Q3 Earnings call transcript