AMLX - Earnings call 4 2023 | Amylyx Pharmaceuticals, Inc.

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Operator

Good morning. My name is Jenny, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amylyx Pharmaceuticals Fourth Quarter and Full Year 2023 Earnings Conference Call. [Operator Instructions] Please be advised that this call is being recorded at the company's request.I would now like to turn the call over to Lindsey Allen, Head, Investor Relations and Communications. Please proceed.

Lindsey Allen

and you and us me Financial full call Josh thank our to on Officer; and Co-CEOs; are quarter our fourth year Cohen and morning, Dr. for our today joining discuss the Jim Good Frates, Klee, Chief Justin XXXX earnings.With made Camille Chief not statements on of presented this provisions XXXX. we that are Medical on Litigation begin, to Securities forward-looking would like based information Bedrosian, everyone make Reform that beliefs, the of pursuant are expectations or facts current our historical that are are remind Act Private and harbor any to Officer.Before plans I statements our we call safe the and made uncertainties we SEC. factors, with those including other set may to risks, and results the our RELYVRIO, filings current and from ALS results AMXXXXX approvals also global PHOENIX treatment our regarding expectations other neurodegenerative the or outlook; implied business and the events timing as AMXXXXX; Global include, and expressed SEC statements those regarding planned the developments or filings of most any results those statements and RELYVRIO known and diseases; statements are potential to: for uptake in for make but could our the to the various These forward-looking ALBRIOZA marketing our trials the limited our ALBRIOZA; expected AMXXXXX and on of III as recent performance.Actual not expand a or other result and clinical strategy and of thereof; forth impact financial materially expected of future in with regulatory and differ expectations any respect of of Phase the ALS and that by with trial

these and Justin. call required statements forward-looking will You not disclaims on law.Now obligation to undue such by the over to place Amylyx to unless update any statements, are I reliance cautioned any turn

Justin Klee

Amylyx. available Canada, for also first year transformational with and in was living full product, Lindsey, people morning.XXXX good It Thank that was was our for a year ALBRIOZA you, RELYVRIO, as ALS. commercial the known

full in including of first the $XXX.X year The generated product $XXX.X fourth net quarter. million revenue, launch in million

RELYVRIO thousands U.S. X our year know are point specialize all the half physicians people with the goal in Canada general launch, of with them ALS tens that are into more neurologists.We of thousands and proud to achieve our reach X and help. therapy. being there people and To We treated having key are people our RELYVRIO use who, at time, about least with U.S. as care We are also we and on prescriptions. remained with approximately medicines into centers, with stable built major these a and continue our have disease steady to the prescribers, and rates that potential ALS and for the a ALS neurodegenerative pipeline roughly on expansion, great a of representing from mostly specialists progress We room concentrated still profitable believe discontinuation significant transformed in to global scripts written new remains number group, expanding XX,XXX on focused of the our quarter, at centers living that initiatives.First, RELYVRIO ALS. the at company.We on made net all patients of quarter. we have at any being ALS, third the in a grow RELYVRIO Prescribing of with for XX half both of people in in

accomplished Otsuka. out Head these including sustained at point, RELYVRIO, market impact position these expect Portfolio On treatment we build of with disease sales leader physicians VP neurologists innovative General care of states, more who and covering with as increasing and half the with marketing, most began Monahan access as of experience years importance across efforts And strategies is QX, to of on initiatives, third, Manager and onboarded and among other an with people living of CNS RELYVRIO Dan and manage Second, coupled educating of that the the Strategy the other for awareness Marketing his we XX practical general numerous side all ALS. recent than will Dan effects.During recently we XXXX. U.S. throughout Commercial. of rolling

the launch our our excited people.Of benefits organization III are bringing experience have many PHOENIX U.S. Phase more RELYVRIO of data. help We to and his us the course, and important Dan will aspect leadership, of will leading believe commercial be to approach our of with an goal

We the data are quarter year targeting before. PHOENIX from during line or top second of this

facilitating new more Medical medicines detail. leadership successful the for remain XXX,XXX us experience to people ALS discuss we launch, rare with global mission.In will be with Bedrosian, brings than Camille living today as the our and the Dr. living advance focus to thrilled access worldwide. Camille invaluable Chief committed on them. have we on nearly to Her Officer, our to to in developing benefits call of addition RELYVRIO more people joining our are U.S. to diseases XX of our in bringing We PHOENIX years

are pathways Israel majority U.S. helping people XXXX, in we Europe taking have and access gain in Canada, in vast generating leveraged and RELYVRIO the people While and of the revenue. early access

Medical Devices making We discuss potential forward. to with regulatory Japan are Pharmaceuticals and in Agency have progress path the met a and

functional and that clinical same longer-term pathways in disease in the opportunities transform care of to symptom ALS and analysis. post-hoc the help tool to which is continue for extend a as a to only first that maintain is important therapy is it and to overall has the survival also RELYVRIO treatable. that to trial the with long-term disease key identify an in engage in goal around ALS slow standard is stakeholders a shown world independence disease other transformation access.Our progression management from to been for is potential We

and treatment.I Jim turn first year call that our full of to quarter continuing have Canada to now many this reach U.S., globally over ALS launch. for year benefit work full with in financial to We fourth the the significant from people discuss our the results look more We the year made in our and progress XXXX. to could forward thousands living will

James Frates

We a for people XXXX year was delivered ALS, Justin, for we've launch Amylyx. good morning.As and become transformational strong mentioned, Thanks, business. living with a profitable a and

QX XX% access slightly Gross represents QX.For early net and The primarily million developing results ahead In in majority greater the Canada in approximately of quarter States. $XXX.X QX and product full our revenues an including net for the quarter revenue the international In net in significant from increase in with the addition, our XXXX. of me the the in the fourth turn revenues of Europe. of the pipeline in was million. proportion third to generated fourth quarter XXXX, driven to pathways million markets, our quarter. were $XX.X product net revenue came year, product Net were to U.S., in year, for adjustments in were XX% increase revenue, line and higher QX QX revenues for net of for quarter product from financial gross let for the and as through which revenues were vast neurodegenerative revenues range. by expected of in $XXX.X $XXX.X for growth.Now preparing disease the compared our a outside full long-term United our to a we're net They to million the revenue of product were

seen until in at inventory outside weeks range respectively, the write-offs we levels significant adjustments to to in for slightly we've in for of expect the what to net in expected, for of of as XX% revenues year, quarter. be quarter were gross $XX.X the accrue similar end United of with full roughly to States.Channel channel at product pharmacies, and million Going X% the continue to the more representing year, sales approximately higher $X.X to X% inventory forward, and million net quarter the specialty XX% to begin previous from were and due quarter quarters.Cost revenues X the

interim or the We States to program QX expect program. of X% be RELYVRIO our either of access free assistance free same received in for continue QX did the COGS to the number in in people sales.In terms through United patient as to goods, of of roughly in XX% they range

personnel quarter Phase Going forward, the driven our in quarter and open-label in fourth XXXX, year. of expenses full for and December of remain III million the in by U.S. for initiated other was was portfolio. spend of increases $XX.X Global the the and PHOENIX range drug expenses, XX% in were which of advancement in trial primarily our to XX% in total increase extension to we $XXX.X million PSP, the related the programs to expect The free prescriptions.Research of development

even for treatment and other in the I to We has near prepare to net were to we as bottom We first year. of the year now growth opportunities therapy a year in like sheet. many we unique deliver our into United that exciting on We're a for first to preclinical full to our full call and study to see operating are to $XX.X and and focused in thousands United in out Supported expenses on position cash for in debt.Finally, increase We RELYVRIO was treatment administrative we build led a $XX.X the our income this for of with strong The having the expanding expect people and PHOENIX expenses, the neurodegenerative and with marketing ALS, our diseases with thousands believe supportive.Our additional ALS We're grow internationally, enroll the work quarter year for $XXX.X X we living continue prescribed Camille. or general study we growth a the and increases balance people a be States use proud portfolio.Selling, This modestly the have million should of line moment bottom in States our we for people. quarterly grow the new enter in delivering the our of turn on the us modestly and personnel SG&A, had a roll work out $XXX.X term full as demand for Again, to way with ORION testament RELYVRIO and RELYVRIO Camille, year R&D quarter-by-quarter Canada, short-term of profits, to investments that to and in with We're and more to driven bring over effect to treated. research already and ALS. is I'd efficacious year. on turn we million transformative expanding ALS both as over ahead an launch. is take strong ended SG&A our profitability been and of reflect initiatives people significant before growth by XXXX.I'll our long represents mechanisms, expenses. in full million as million mainly we by our line. we expect as the additional call patients

Camille Bedrosian

in will the for I morning.I which population first evaluate Ultragenyx, a journals.The the diagnoses ALS independently now we Alexion and an Functional and PHOENIX trial of endpoint function functional with people candidates the This and on. ALSFRS-R, Jim, treatment the uncertainty publications disability survival loss.We Phase also being up ALS and one enrolled consider point good baseline I what wish was same to today. function of baseline lives results worst and PHOENIX neurodegenerative July families. around and day, Journal have will on more to and enthusiastic a conscious efficacy III in speak with the diseases.Many Amylyx standard we has opportunity treatment work to CENTAUR, several possible in people in extend onset. help overlap They of is the locked the people is company to never as the X ALS, Amylyx is from the other Canada, trial inflection in we the positive overall a the measure living the since speak safety with and people made as maintain teeth gold be this just in being of Amylyx, study the of the CENTAUR a the met this relentlessly people score treated team or Thanks, the for in living next contact corner, to on potential to great ability Medical to as with presented study The show trial. walk. in the important can month and was too living first redefining in brush in provide living ALS as to and therapeutic completed near just have ALS PHOENIX the ARIAD. Knowing the ALS our U.S. population to strides one of its mean therapy data benefit, in CENTAUR. changed. therapy with and data a might you symptom and CENTAUR of independently, team neurodegenerative using approvals ALSFRS-R placebo-controlled ALS independence would And RELYVRIO living the England ALS larger or With pleased X characteristics ALS disease and build XX result weeks shown again is wake their discover ALS and substantial with New the would achievement generate are of ago to put morning joined a change lose which of Medicine, different that PHOENIX a all top that data additional of button over peer-reviewed largest shirt, seen meaningfully same excited randomized their perpetual few developing of at state be they PHOENIX robust population enrolled to living in we be RELYVRIO families and ALS hug this with trajectory a called are to prespecified Psychiatry and what led doctors person. endpoint. broadly.Prior progression, with I'm lenses, data Amylyx anticipated line pipeline. in Journal from has you am people to has only is other going at body, how I live Chief ALS a their the trial. essential, The within of loved the disease.Moving innovative slow ALS.Baseline in PHOENIX loss their of months part mission-driven CENTAUR diseases primary to to ALS is CENTAUR, ALS their within and R&D will Rating to and losing Neurosurgery while the at give the with of its ability disease XXX people a of Every of of This never eat, an observed in demonstrate and Neurology, trials. be ENCALS before in only primary a XXXX. in regulatory Scale-Revised progression and on about positive X the PHOENIX point with supportive time in make Officer

We are several as milestones in also [ may with neuronal coming number and death across expected have believe programs XXXX. applicability We neurodegenerative known RELYVRIO, targeting other ], advancing up important a of diseases. have AMXXXXX

There trial are expect death syndrome. year. treatment XXXX and on PSP to in deafness, in Wolfram resulting of to a XXXX.Turning Supranuclear posted ORION trial report initiated is in Our AMXXXXX ataxia, now Wolfram typically results of Palsy, in webinar half by the line adulthood. multinational syndrome We for in fully III top was neurodegeneration no enrolled, website our to or detail of is we for our Progressive scientific an genetic The early II July this Wolfram Phase results in December blindness, therapies failure Phase in HELIOS trial XXXX, and in ultra-rare of PSP, the now rationale the diabetes, disease on second approved that multisystem leads syndrome. AMXXXXX or anticipate AMXXXXX we and shared XXXX. in

conduct Phase Our to Washington our the conduct many R&D to II University research, has trial. led collaborating with which to decision for team been years

mean to am from clinic Wolfram forward Calpain-X with call community will in effector would a be HELIOS and of by to very Josh. ALS.Again, many looking studies axonal a people you.I pathogenesis of the Amylyx enter for which implicated is meeting turn unmet advancing are is now I year-end. the data through the degeneration, and where syndrome, critical targeting are look also of to expect Calpain-X of candidate part the is high.We oligonucleotide excited need incredibly forward over to to AMXXXXX, antisense the We IND-enabling what our

Joshua Cohen

await the Camille.As we yet program Europe, preempt line look into help question marketing help aspects we as of engagement will in in of are as we eagerly there's quickly benefits Phoenix not clinician support agencies, of and And in launch. to our regulatory to the do to global no the possible.And more all top event and of outcome and plan our people your results, access in reengage would believe know PHOENIX supportive the Thanks, updated today. of data many developing our may of data that be PHOENIX supportive a course, be early data, goal of on minds, the RELYVRIO including

experience, from Chief Arsenault Human she Resources Officer. years Linda us She to this, novel slows are Dan, addition biomarker a from year.Lastly, continually are in straightforward transform onset not to provide they the ALS to as with misdiagnosed see addition, experimentation are recently data leadership where it ALS path. accelerate diagnosed time could we earlier, improve the about year diagnosing this that XX and of results striving To that from And therapy ALS Chief initially assist a people to was a to over and end, with new In Many treated. is we including spent Resources we valuable neuronal recently and symptom that and be ALS; diagnosis ALS.Current to is Sunovion, specialists way and we Human are we accurately panel takes death. working joined developing this on takes before that initial Officer. to Camille suggests a diagnose thrilled accomplish brings in our several intend the time most are and are

to welcome to team.In closing, many we proud a our to had living thousands of launch start RELYVRIO her have of and excited are XXXX. achievements we the strong reached made in are We We instrumental our top with to our ALS. quarter the for line believe, In or be second growth people will if of we which before, XXXX, are we PHOENIX trajectory. anticipated data, planning during supportive,

a which us, our evaluate substantial We our ahead U.S. us the in profitable and with neurodegenerative to launch RELYVRIO pipeline. have diseases.We our pipeline other enables R&D opportunity of commercial are both in a with self-fund company, globally and and

delivering franchise we'd and happy world.Now, the long-term the up intently building take innovative please with impactful living your open on developing be call diseases We treatments people differentiated around questions. neurodegenerative a are focused for to to and Q&A. Operator,

Operator

[Operator Instructions] question Geoff Bank of is first from from Meacham Your America.

Chen Yang

quarter? This is redesign, D And Charlie what's growth about patient what's net on us the for this the Yang about year? given talk guess for this can can year, Part compared also your Geoff. coming you prior you for this potential the to quarter adds fourth tell just I projection for secondly,

Joshua Cohen

Yes.

So start net redesign on the to maybe and as well. on pass Part the I'll benefit Justin I patients D could

redesign, some at for the then that D a year, So longer that is of during happens kind full degree the phase steps. and of Part D redesign into benefit The catastrophic co-pay the happened start goes the implementation There's is in Part of patients. this it the big effect change of in no X it year this XXXX.

as free view drug think or to of assistance positive for But patients. financial course, we when already necessary. that provide have generally robust I So programs we

patients. going be on to impact think don't pass major business.I'll it's Justin on the to we a net So

Justin Klee

said same reported the prepared approximately remarks, it quarter. patients were the we in our to QX, stable meaning third as net what we therapy on In level Yes. was

Operator

Bitritto-Garg Neena Deutsche next is Your from Bank from Canada. question

Neena Bitritto-Garg

a the in could of gross the I bit increase did you in wondering dynamics U.S. know you net the a price more if I impacted was gross just U.S. numbers to the take specifically some So talk about that little

a think U.S. that offset. compares explain So we just contribution if that was about that how how should forward. wondering moving ex And quarters you and to little more the and if bit then about could of maybe prior the magnitude sales

James Frates

you realize part I but Thanks, Canada, Sure. were Neena. Deutsche good. didn't that's of And Bank

I net, remarks, see most yes, we think the I typical Canadian really revenue pointed the I sort you So the in actually to upper-XX sort of QX, there of change, out fluctuations. European in of saw and -- gross growing. And really came that the as mean, from the

United to So States. those do than the we have gross higher nets in

than impact in United modest so a And to the really rate take did price nets didn't inflation actually the at we It States, increase. and gross less all. was

successful contribution equally how all disease well quite think be we was opportunity, to a Obviously, goes, strikes and retain for portends That's grow ex access but forward, some U.S.So for in stable, Europe, And global for are think us far in of and program for the excellent some of obviously, I the quarter-over-quarter, the as France not is regions post growth the majority is full programs supportive.But remain those and to a out It And from, paid. insurers. around as as this in it of We opportunity world move right? our disease point stable. looking have PHOENIX future. wait approvals hasn't want. that other global States we from mentioned, back for quickly unfortunately think and the the revenue we'll global those time. that free, we changed. That quite the So world. There there's people a our be slightly doing we're really of significant our it early does a to a all Josh with announced ALS broader came United October. European approval contracting is rights but treatments sales, PHOENIX, any major cry be Canadian But rare as data access the I product. the in as and across appropriate, programs related over the access U.S. And the we did actually in access think to managed see the know, point should that I we'll course, did we you in

Operator

from Jenkins from Sachs. Goldman Corinne is question next Your

Corinne Jenkins

provide a you're about duration in seeing benefit update when then us Maybe, talk by therapy to translate on specific those to as strategies follow-on, improve just like, you're therapy? an me, and of maybe duration the you measured some the to that U.S. you revenue? as of real expect do deploying into for potentially the of And can

Justin Klee

Yes, thank you the Corinne, for question.

So steady. we've and held rate it's persistence our -- our X-month been on reporting

U.S., in number XX% approximately Canada, still RELYVRIO, still And at seeing months. initiating in XX% we're months of people the So after on is roughly that X X treatment.

have I ALS treatment. practical So prescribed -- There found is trying education. strategies I others. what down doctors, that doctor also stay when as for keep applying thing is we're much from their rates much, are on likely on much they're symptom taking we're is learned by comes learnings as potential trying first more doctor, than And those to think will the that or to very that side Canada people longer, disease management them being one that U.S. because a any the to has then they're mitigating slow intervention. ALS, on transform we've some and focuses those treatment higher to it from look this as individual will to focus persistence And effects.Again, we're that that alive we it think to mostly focused I historically it think Canada at is know doctors from what If you looking down well

there And of that And do manage how is, we so we are that practical come ways as very part that. things can them. up, do

put we, think, translate when revenue, our terms now made I I recognitions efforts so Monahan of recently. as commercial initiatives that in in will many to U.S. well. think leading these place. We Dan We've have And

throughout all to year. build of So things these we expect the

Operator

Evercore Michael is Your next from from question ISI. DiFiore

Michael DiFiore

the happen? that from any campaign or like learning applying follow-up and add to for I may me. What's color early. pretty you my the prescription U.S. restriction how when Canada taking it's we expect any on been could thoughts you reception far? And lift the Two on might prescribers? it data? is, to X, When reporting is Number of so realize

Justin Klee

and you I'll certainly Thank one. the first Yes. take

we're the So I think feedback. U.S., now had I agree, learnings so positive it's but Canada, the in that very from the initiatives we've early, advancing

think that I if that, have does been mean on in largely that's because it's historically disease is again, about think try it think I that the focused transform short, what you a to available, symptom to education. tools management

just to education. I mean, ALS, they're people. very, care of therapists nurses the and So right first down alive of that's keep changes amazing education about well, and slow is of a with focusing think of not on provide sort And one again, who And this side at effects, not if side to those your And that had that big comes doctors mitigation think all, uncertain. be manage in I and for for it's people talks and longer, disease, all our potential the I but it how just second, example, not the deal. transformation. one Again, any they're think things excited down as these we well. But that effects. can cure, just a but saying on we, has to this important I see the opportunity that, But ALS even it things partners may very past, you the then

think has I So that reception I say the would excellent. been

previous I think was question, year. I impact we'll build see in revenue, saying that As continue the long-term the throughout on to the

James Frates

maybe the prescription and Mike, the access I'll question the Yes, on take data. to

our atypical on that that we're we and indication. any can change now. focused where sure focus disease making it's to think I in of not our internationally. to remains. deliver plans be it not rare don't particularly have data have to And I situation, really after think PHOENIX We growth, from the a going available read That's

Operator

question from next Suvannavejh from is Graig Your Mizuho.

Graig Suvannavejh

the novel into commercial give the changes early any insights One, Two whether any make trying I are trends? of you curious could biomarker in fourth that questions, and perspective if like XXXX, progressing a could. quarter you're from given to versus uptick how And what there's things some -- included biomarkers be then could panel, ALS exact be might about secondly, appreciated. types in panel Also would developing. this there, that that or provide you're which I'm on you color

Justin Klee

Yes. Thank you, Graig.

into previous community. say, was initiatives So break saying we've out from a fundamentally categories, educational broad with great I not. the we've I have things reception think sort think, I the think Others is I in of specialize the the remarks again the ALS. in I who changed in their I seen, medical seen people X practice. did would maybe opening I as have And as physicians think opportunities, first remarks, And there, some who

effects. there's benefits specialist. then primarily secondly, tools a school. about I And a think so RELYVRIO mean not ALS might for learned for specialist about well it's be are to -- half or the cared as it of with there, And as XX -- people their is it's them for I practical they old. ALS And of XX, medical and mitigate on of make years to in side them, educating don't -- knowledge awareness it what of many tools by

unaware advances they're has So general that very the made. treatment, not the our but even of just field

in So definitely think on those a increase the there, segments, as highlight opportunity RELYVRIO really their the the more confidence awareness for opportunity to well generally diagnostics both I well is of increase is I that as for great key.And both I think awareness would in and PHOENIX I'll to specialists pass medical Josh. the potential patients side, as to community.And benefits of really the

Joshua Cohen

Sure.

that pathophysiology from about the you when I that we neurons have or second that diagnostic, note to ALS over cord the from spinal So to the of is go degenerate thought then more that when first brain the ALS, muscle thing in the the quantity spinal to neurons the a you of about think think massive just the X course of go years. the and cord set

or must measured stands be or something at So least that released that measurable reason process to occurs. when it

the with of can to we what has diagnostic collaborated together experts and up are in effort those towards space. There ALS, nobody's a the thus from we've that seem serious biomarkers but in is not And far markers develop So several to diagnostics. or space. there clinically been down ALS making in field try really kind tell serious the looking be towards in taken to many a in effort a

program. about quite that we're So excited

there, we'll fruit data but be low-hanging there's on think later reporting I lot that a this of year.

Operator

from is Goodman question from Partners. next Your Leerink Marc

Madhumita Yennawar

patients with RELYVRIO disease closer is just on diagnosis maybe centers? on than And in more starting of and secondly, experience been their Has Marc. patients been in launch? in neurologists experience earlier the outside of line engagement high? Or general then your the to -- Are Madhu the This who far. earlier on now are so what's for centers there or your there community on excellence curious

Justin Klee

Yes. No, questions. great

get closer naturally, over So diagnosis. who we'll I I think, time, think to people are

then is expectation changes population, about launch, looking second and you centers, people experience to think of then And we're as yes. the you think the the time, I question, the over that at And your persistence I closer get efforts on at diagnosis. well. how and outside closer prevalent whereas education think the

our think remains concentrated I prescribing So still. fairly

doctors XX account you majority of the ALS all prescriptions. -- imagine, specialists. vast roughly So And are are as for about half those might

Dan have boost we're just broader So lead the excited I very that well, community. in general as some think off, and to of initiatives to medical kicking awareness our are started we've

so broaden most who those with These expect see where continue see And do think have to their think people people medical ALS. changed And we the practice. to who start the place ALS base throughout really then are from XXXX. it's the prescriber throughout we'll have year.But we'll fundamentally specialists I a to I nice the

it's to we and foundation So broaden nice I really a then have think there. from out can

Operator

question Your next from is Baird. Beatty Joel from

Unknown Analyst

implications could RELYVRIO on what Beatty. the Ben TUDCA-ALS us Could trial when through walk for for are you is be potential results announced? This Joel the

Joshua Cohen

Yes.

think, different really trials. different I are that it's first, note products to So these important and

RELYVRIO, phenylbutyrate and combination sodium a co-formulation. a and of proprietary our taurursodiol is So drug,

And was run also it CENTAUR very during smaller PHOENIX design. in So academic a trials the run trials. in with different I'd TUDCA designed most were primarily rigorous these trial experts an is controlled TUDCA. of not that's that a kind in the of all of the thus are field, state-of-the-art and design peak way. same quite say, as ways the far, different these trials tilt COVID. of trial, and been product additionally, the running It's some is using the with

will between probably strokes think two. that they're don't the there and I So we the comparable broad be really think is, read-through

comparisons wouldn't as draw comes. data that So those we

Justin Klee

and same ALS is too, the FDA-approved medication in reiterate, just slow Functional ALS shown England the that on Journal of the New published only Scale, Medicine. progression was trial would was clinical extend the I And RELYVRIO in to Rating overall survival

FDA among That's that's such think why seen I why, So we've excitement. specialists, the ALS medication. approved the

Operator

Your next Ghosh Ananda from from question is H.C. Wainwright.

Ananda Ghosh

the First evolve inception. of the have And of It milestone from story for last, being all, has maybe completing X been the the the I congratulations great launch. on questions. year reaching the seeing first

is first The to PHOENIX. one related

definite the the patients. inclusion probable side, ALS PHOENIX mentions On and criteria clinically

one the of define is, And So was rationale my ALS group it way does that probable clinically analyzed? is patient? data including the how What behind question the how change do patient?

Joshua Cohen

Yes.

too affected criteria try possible maybe probable is between get different body ALS ALS, the is probable people regions scale. probable defines in essentially into And and been -- X shown over first, in probable different of potential are probable first, divided X. criteria so with with many is clinically about ALS. being supported on weeds, them not X; being X X plus Escorial to terms the being including the body being The of possible but time tests; definition, the that definite. XX% convincingly the of on lab and possible the groups, or even have by What's X; this ALS definite lab many So or difference those have regions of suspected, lab-supported, probably will El I ALS how

across important X the most within the similar. for a has that, to populations not since how and the a going the important characteristics at So statistical more most certainty. scale It's progress month a of of progressed.When did is we very baseline symptom X and actually PHOENIX which the like thing compare it's about modeling, ALS on the diffusion, perform. body how baseline, basically not of time -- scale far it's baseline which are of They're I the rationales onset, is group, when them think is on a and point X the consistent ALSFRS-R definite measures But probable does likely CENTAUR fast the one baseline X in that within and important, look when for to you progression we're trial. and patients more the and we was including give on cohort much thinking

Ananda Ghosh

it. Got

is related biomarkers this think, was there very about question Yesterday, the rare rare Marks, accelerated was public in the second pathway. discussion using for the disease to approval on biomarkers disease. The space, Peter I positive where

at approval panels ALS, Now, develop there like developing other as ALS, there to was diseases is accelerated and being such in pipeline are company discussions that diseases looking help strategy of where definitive biomarker surrogate on Wolfram for biomarkers pathway in a for biomarkers, might to you very the syndrome the that rare rare kind get like Wolfram?

Camille Bedrosian

question. is using to around diseases will accelerated are This individuals see And opportunity in and giving to Thank and do Dr. heartened you. impact, sooner, biomarkers appreciate of often possibility It comments study tremendous approval those disease drugs process individuals I impact, Yes. by Mark's treat where available a sooner. small the opportunity window very rare opportunities. therefore, Camille. actually the for disease. make in is particular, We the neurodegenerative we a there have of the

mention -- we're impact. trial, of ways as which the similar for profile we looking consider learning an Josh biomarkers Wolfram be initial You diagnosis, have there. well can biology biomarker clinical at the ways potential as about And in with syndrome our heard as

tuned. stay So

Operator

turn Mr. this time. for call closing the I now no There questions further the Klee at are remarks. back to will

Justin Klee

call for Thank our have all hope your and a joining for day. and you, operator, support. you us We on great you today thank

Operator

Ladies has now ended. you. gentlemen, all you Thank and the Thank for joining. conference

disconnect. You may all

Amylyx Pharmaceuticals (AMLX) 22 Feb 242023 Q4 Earnings call transcript