Earnings call transcript Q1 2023

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Lindsey Allen

Good afternoon and thank you for joining today to discuss our First Quarter 2023 Earnings. With me on the call are Josh Cohen and Justin Klee, our Co-CEOs; Margaret Olinger, our Chief Commercial Officer; and Jim Frates, our Chief Financial Officer.

Before we begin, I would like to remind everyone that any statements we make or information presented on this call that are not historical facts are forward-looking statements that are based on our current beliefs, plans and expectations, and are made pertinent to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to our expectations with respect to RELYVRIO and ALBRIOZA, statements regarding regulatory developments and the expected timing thereof, our business strategy and outlook and our expected financial performance.

Actual events and results could differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC.

to Amylyx undue update disclaims unless by not forward-looking on such cautioned required and statements any law. are place reliance any these statements You obligation to

call to the turn will I Justin. Now, over

Justin Klee

and good Thank you, afternoon. Lindsey,

As everyone an need is fatal ALS caused in and our and these knows, mission other progressive to diseases. by enormous the one relentlessly day unmet and neurodegenerative this on call there's It at diseases. Amylyx suffering

investment meaningful treatment mission. in enabled continued to toward Our our make advances delivery and us

During in term met continue placebo treatment benefit These the RELYVRIO. demonstrating hoc set generated function to a with we outcome primary benefit longer for Both a ensuring data and that XX.X million Reflecting the be living in revenues. statistically approved can access first showed pre-specified quarter, toward a RELYVRIO post of trial. net a is significant and to goal controlled in person its significant has fact product on progress our ALS the eligible we treated. analysis. first every suggests ALS survival only make and and randomized ALS

of community the ALS quarter, saw the a we as and ago. been do. And manageable many level RELYVRIO There ALS with we for launch that in an act, The The our interest being believe years people US living that XXX globally. to full the Amylyx day toward ALS with XXXXs six coverage, people living have options success we more with a delivery and into from will least the meaningful for with team, US remain the just first is therapy XX% ALS now first in approval ALS at ALS. community are XXX,XXX one of RELYVRIO. continued step important characterized our the over treatment first more eventually of be RELYVRIO broadened has a approximately In months, quarters foundational people two since ALS with on in Even XX,XXX of of insurance waiting known high also living over was levels disease. disease engagement high care and

our are stages at We hard journey, work. and early the remains of team our still in

plans at our medical we broadly have to capable remains scientific we Europe the mid all to believe are diligently process. CHMP and QX. ALS regulatory ALS we is help strong earliest in and with an Overall, preparing process Shifting leading decision community people by the a to to the living and internationally, world. advocacy continue from opinion our medicine year supported our is expect that a we who bring a eligible and around review in ongoing, position The team

approved. We continue to execute prepare launch EU a in the successful if to

progress team's of our our mission. We are proud advancing on

turn over share the And to update. call to Margaret now a commercial I'll

Margaret Olinger

Thank you, Justin.

As since remain we key enter focused our US launch, we the seventh month three priorities. on

ALS RELYVRIO and is a This effort and to on first is hoc first with trial, demonstrate ALS for drug education awareness post living with as function approved and analysis. and that drive benefit statistically The in a a RELYVRIO among about a clinicians. includes to people well benefit longer a significant as survival clinical adults term educating our

strong yielding are awareness drive to efforts Our results.

We RELYVRIO. are interest seeing continued for demand and

double people at As the quarter. RELYVRIO the US the RELYVRIO were of of on in XXXX start roughly of on the XX, than people March number there more

gained We many are have pleased our people that to treatment. important this access

the additional some a context think our it's I provide minute to on of launch. spending strength worth

ahead [indiscernible] of rate our expected. we first moderate of there still was to While pent and patient's begun The demand, net up quarter, were the as knew fourth has quarter expectations. well

demand still significant ALS, with see for and alike. living physicians we people However,

the both [indiscernible]. broader growth, for room of plenty centers, have and still neurology the community. ALS we Importantly, at top

quarter, centers let of run the approximately end a of top person concentrated, ahead with prescriptions prescribed opportunities the that least progress, also of centers, since first RELYVRIO growth show our XX% ALS of at mostly remains all approximately me of and us. US major out fairly Prescribing one the By XX% the to prescribers launch. few Now, prescribers approximately at quarter. representing through half metrics but the had roughly key the during ALS RELYVRIO XXX XX

key we ALS see to to group encouraged top an of the broader opportunity deeper uptake are we these data opportunity points, continue penetrate centers, with While the for and and prescribers. of

group top broadly. Additionally, education growth outside we expand of large we our as additional believe we outreach have untapped opportunity prescribers of and more for a this efforts

priority second can who ensuring possible. work and payers access has person that every is efficiently our engaging to benefit eligible as of towards quickly with Our RELYVRIO as from goal

At these RELYVRIO. the approximately access insurers of including broad policies, many first published provide of vast the representing insurers, national U.S. lives, to end of regional and covered of The plans. quarter, coverage formal majority XX% have key the

first who we through ALS medical with are exception living been the requests people pleased prior process approved go of XX% admission. approximately on that For have the authorization

a range terms interested initial sense living and We RELYVRIO. diagnosis, see people time to in of wide access gaining of continue in with to ALS

plans remains team during the this with of half across And we will year. the continue formalize insurers their Our to country. first most engaged anticipate policies

ALS can. prescribe Amylyx. with ensuring their best the positive get quickly interactions therapy is people RELYVRIO RELYVRIO experience RELYVRIO journey living to facilitating positive people's as process people to have includes eligible clear possible This organized, and third as and optimizing ALS, as an with interactions we Our have access clinics priority treatment with with accessing

people to Our XX we ALS, first form, decisions. about formal to days receiving this enrollment our quarter. make team In little XX% metric prescribed the XX the assistance And an additional days program access between taking having limited patients. people first being patient the of been in RELYVRIO are more a available interim down the in fourth programs. our an therapy part get On In shipped the on average, RELYVRIO been RELYVRIO in than program benefit and insurer, who hasn't coverage these have on access working were insurers expect of second took it quarter. cases and for quarter, progress eligible from of living quarter where granted with through with the roughly expeditiously is more

with We made progress the to as potential and on RELYVRIO with are so therapy ALS, to disease. which access foundational far eligible pleased living neurodegenerative we've every a person our that we see goal has ensure

strong RELYVRIO most hope commonly a launch And is it medication. become ALS to Our that the will off is start. our eventually used

large on in While RELYVRIO launch we the also opportunity that U.S. of internationally. the clearly we focused have are a

more XXX,XXX people interest we and coverage with in affecting to insurance disease, timelines global high in coverage. ALBRIOZA worldwide consistent continue remains expected a for than is public ALS public Canada, negotiate the

as ago, commercial strong XX few we opportunities years as to bring AMXXXXX introducing ALS to record possible. therapeutic rare with globally people appointed disease Masako Pacific the a to therapies addition, our as He of multiple general in brings lead industry, across operational Asia with Nakamura worldwide and management a of efforts and Latin in leadership In weeks track biopharmaceutical experience areas. many additional pursue we America,

world. decided explore opportunities to are pleased further join the AMXXXXX to team for around access We that our very she

now on R&D turn an will important our to pipeline. to update the I Josh call provide over

Josh Cohen

with very to quickly our ALS. Margaret. Thanks, pleased how with we bringing are important We're people new treatment

criteria. interest efforts RELYVRIO scientific day-to-day Our of the needed commercial further launches. success clinical development They trial models To bring mission. of biomarker investment investigate Pegasus encouraging more There's in pipeline among AMXXXXX at worldwide. in data AMXXXXX continued randomized to the effects Alzheimer's neurodegenerative community data positive enable the which ALS the and other people preclinical and our reducing of have These disease support of wealth phase the our neuronal study tremendous a to to demonstrating advance look living also research we the death. focus randomized remains our top enable to diseases on, and diseases, focus from to with we prioritize needed in in ALS, two the following

of existing a to adjacencies strong disease, to into and ALS, move need, three unmet natural synergies history support effects, with potential and scientific robust and of phase interest study KOLs. understanding biomarkers directly and from track the pivotal treatment Clear rationale,

to or three excited all a PSP, phase Palsy, We plans criteria. announce initiate these pivotal Supranuclear AMXXXXX meets of of global our are a study today which disease Progressive in to

you disorder that who translating neurodegenerative typically fatal just be XXX,XXX is States. and familiar body movement. It's XX within walking those to affects may roughly of not estimated the PSP, eight For with between balance, five fatal progressive The rare to speech seven United years. it and a prevalence and XX,XXX in to worldwide, people movements, people five eye and is to swallowing and

There PSP. are for currently no modifying disease treatments

is excited oral with total and AMXXXXX to key preclinically I with potential AMXXXXX strong in outline. and also degeneration. in This is with PSP. both for a for AMXXXXX is tau, study AMXXXXX. to XXX pathology both been that to addition Hallmark work rapid which characterized ALS degeneration Pegasus PSP And study, strong protein of characterized FDA Alzheimer's significant PSP, phospho our In rationale approved criteria now disease has will them people natural brain and AMXXXXX test treating its three Alzheimer's there the significant protect disease. nerve a by well of in a clinically use opinion to living need well from we demonstrated has PSP, of history PSP. CSF protein of for scientific a the neurons unmet lowering an medication and led and in are significant regions of of to tau the treatment is lower meeting deposition against support in statistically the affected of and the significant tau a significant shown a leaders to tolerated tau phase

planning and designing In study. the

plan approximately trial collaborated people study PSP With groups key in IND making and the PSP likely randomized a placebo enroll this controlled have this advocacy in living to-date. people in with We hand, academic with to working an we largest field. leaders, open global XXX

We expect have year. up and running to this the of the by end study

we treatments new no We there are especially disease. can currently available this for modifying treatment a options, provide devastating since are that hopeful disease

also to failure, to this Wolfram phase nerve Clinical Journal papers deafness, reticulum is disease, syndrome. Investigation a and AMXXXXX Data and in early blindness, insight. syndrome in discussed launch stress, we ataxia, we trial reducing three models a study, year, a as Several believe we we prepare two syndrome leads diabetes, as phase studying on past, in often now system published have disease characterize stress. in study the the This participants. hard in were multi and remain at AMXXXXX, a syndrome. we adulthood. of in announced resulting Wolfram Earlier disease the Wolfram plays Wolfram degeneration, death AMXXXXX of the prototypical endoplasmic in enrolling is our While work that pivotal Helios, role

study future key guide this top line study the results provide believe data year. will and We from to next expect studies

Importantly, to We investing to we disease and approach is combination are also ALS continue believe in more pathogenesis take implicated to it transform a how ultimately and going ALS that treated. to a research in more make multiple is cure. pathways cellular manageable, find to targeting disease new the

investigating called R&D AMXXXX that this different potentially pathways For diseases. underway therapies IND well. AMXXXXXX of other and complimentary an developed, progressing ALS neurodegenerative or our with are and internal reason, has we oligonucleotide, This treat team includes enabling other studies are to antisense

both to build pipeline, sources. continue internal We through to external and our expect

as to another a the announced no XXXX. progress of be more and reminder planned. data AMXXXXX, expect to study fully Before we until or in continues we was on be Jim, participants, least enrolled XXXX. XXX that mid mature Phoenix, call to year people Overall the therefore survival outcome primary outcomes data with ALS, over with three our mid and will study won't data there several secondary that take that will February, readout, In available I and at interim phase and to the wanted share turning

I for to the call review turn financial quarter. will to the now results first Jim over our

James Frates

and million quarter for mind And point for Inventory volume that channel free approximately roughly keep $XX.X for at for the [indiscernible] two encouraged strong. grows. a or $X.X community. by revenue the as RELYVRIO from our We're of of were in revenue program patient of our These added primarily vast quarter to million inventory compared the we to of the and product XXXX. for costs of through phase interest strong of with $XX.X States. expectations expected, consistent Research XX% in XXXX specialty we're businesses the a the From we from see as the three fourth the sales [indiscernible] at to support the with product net revenue expenses financial with our and XX% quarter, the period were Thanks, ALS net compared development United and the were range. and either the Josh. Net our pharmacies. weeks as adjustments view, study the continue our were people interim expectation by Phoenix in approximately million programs. $XX.X in the XX% quarter levels majority assistance in quarter to program. in purposes, same that million for million $XX.X it XX% modeling access in on range quarter driven for personnel receiving demand our of

in in incur our to expect meaningful PSP. expenses we we three increase Starting as quarter, R&D the second will study pivotal expenses initiate phase

$XX to to remainder quarter same administrative the as R&D pleased results You million investing with for expenses or range and million $XX.X our million launch, year, we're of to expenses net year. including income, compared in the were XXXX. we general $XX just quarter, Selling, two a quarter million our the through We're strong for remainder SG&A [indiscernible]. this our the in per million $XX very should year. increased a the Overall, for this quarters the our of of expect move million settle period in SG&A $X.X around of achieving spin expect quarter $XX into support in commercial to

investments goals profitability We results I near has the top for long our our a to in diseases. overall potential in investors, currently our We're line without We're neurodegenerative pause standard investing ended demand strong of to to additional want it term a $XXX.X provide profitable a well-positioned RELYVRIO the want the the much the our to on driving and position term revenues to become profitability need financial growing of for and to the short cash build We organization strong driving as X ahead capital. pipeline moment needed with of programs, care, and discussed million reiterate for quarter for long financially financial expectations. treatments term a raise fund RELYVRIO with term. we that debt.

guidance as quarter, we're guidance a the over we the some it's is was importantly, our with most time. to a many on progress lives fairly just gave provide the specific impact early quarter, Last and guidance. simple and call in The few the ALS. going I'm launch, we first development year at how positive the road of quarter Since for on for execute to in word premature and the the on that Finally, people on ahead so our we've quarter, still reported quarters second or specific the have Midmark. execute revenue programs. next of a pipeline range full made, ability living excited on this about

With over call remarks. that, for Justin closing I'll turn the some to

Justin Klee

We covered Thanks, Jim. exciting And joining everyone us thank for today. of news. a you to lot

relentlessly to disease remain and on our help goal just know into will with as profitability well that first relevant our has gain Our market We favorable achieved that with been a already We're we clinical committed our and that biomarkers. to this other profile the we pipeline another expanding on the PSP, is people in second quarter U.S. progressive to likely is in a have launch Canada demonstrated ALS and commercial And diseases new and more quarter large U.S. safety commercial the product later to as access and of very ALS year. proceeding has of effect our ramp a in a shown therapies. additional neurodegenerative Europe

to open Now, the up call Operator, we'd questions. please take Q&A. happy to be your

Operator

Instructions] begin go of and question The question [indiscernible] Bank from Please comes answer America. with session. first [Operator will ahead. We the now

Unidentified Analyst

for question. taking Great. This Geoff for Thanks is the [indiscernible] Meacham.

So have I two questions, please.

expectations one parents have little kind what's the that we more of the second you rate Thank somewhat provide a any And the to Can second mentioned pace discussions first details, is, that expectation provide your the you of you The moderate you. year? remainder the just question of perhaps just to has got for going quarter. [indiscernible] my

Margaret Olinger

Sure.

we new for to and launch treatment you to the a that product significant first the hope both especially in more thank question. clinical much incredibly demonstrate with in statistically a And Margaret, is very our this to given community, option importantly, this ALS be our survival. your So ability today. pleased to a And continue is and bring trial, function benefit

So quarter what started the patients, just maybe XXXX roughly if could a double again, key ended points, we few quarter. I of at with the we reiterate the beginning with

And XX,XXX that's ALS. about the with of patients living XX%

can't surprisingly, not forever. patient our So net ads double

be are lower QX. expecting delivered number QX what QX in the we than and will So in we

I second RELYVRIO centers the And a both the we with and question we're payers HCP. at having was to see to in significant with covered both very get with as continue to pleased the And and that all we're first published of depth broader key making as and us then grow a from only of the better expect to have community. year. over tremendous the we we progress for importantly, demand lives for the the think interest XX% more payers breadth in and again, ALS opportunity well on policy, half date neurology patients

Unidentified Analyst

Thank you.

Operator

ahead. [indiscernible] question Evercore. Michael go Please is next with from The

Unidentified Analyst

my Hi, on few And guys, me. question. quarter. A congrats thanks the much taking for so for

three be? steady of second now to given That's OS the the And patient least The commercial data or the the more big have to perhaps is previous bolus have long how to my this updated question. you the one phase on that And critical net of first endpoint. any that provide a could on fact views beginning could achieve rate that going Could payers and last it's you question, trial, come up trajectory of you take said to at is state moderate? one, new a starts? I that is regarding read a like it mentioned the first board. patients follow ads out, more year finished how And a you before initial

granted conditional their a just the still positive if ALS until data be there you based a approval EMEA approval EU EU approval in on [indiscernible] on be So in? if full in expecting we finally are Thank the comes you assume OS maintain alone? on FRS to could the Phoenix, data when FRS ALS, and you. could based And scenario conditional [indiscernible]

Margaret Olinger

thanks your question. thank is you. Again, Margaret. for This Great,

bolus, the early to will due I too we in and in our high when And can to really we see Regarding But that what know up they it's demand tell that frankly, we expectations. did were ahead of bolus the level quite say demand finish. QX the pent that is of even QX, had.

So for rate and to we the ads moderate. I that patient the have again, opportunity want growth, a we And penetrated. even we reiterate, remind begun we one new have have see you It's typical because tremendous just accounts for key within all to some see XX% rare prescribed account, ALS you said account. of least account, of at patient one centers the one see you the metrics, every of key But disease.

accounts penetrated. So highly some are

just have into ahead great accounts get out of penetrate. community. we really have us a to room started some And And neurology broader the of to deal

tremendous growth serve that see we remaining on again, us are us. all of depending the ahead So to patients

Justin Klee

Justin. this for the Mike is question. Yes hi and Thanks

of for baseline just sort first everyone. So

the expect in earliest continue team third an to preparing launch. in and the decision the for from So quarter. in the meantime midyear opinion our And at is we approval CHMP

approval. affect and of that Phoenix So, the conditional trial, in could terms the how

be in that our follow on you a authorization, if that condition. won't that approval approval, approval single and decision, a be a first you So would have terms works of know what condition but get get we or with renew so that would that until trial, is and EMEA the way final every on this then the the to you the expectations study, in you marketing the Phoenix is our we it the that do way expectation meet conditional year full the but So until it's case, that conditional

will is really the So then, results. the the, we FSR the up the condition depending or on regulators. functional ALS results, meet that's to And survival question the

the functional we ALS. if we high say though, that have best have if seen level if in is a a we it's both, have benefit survival data benefit, While anyone's

situation, So ultimately, EMEA. but a CHMP think and it's the I either to up is very positive

Unidentified Analyst

you. Thank

Operator

question Jenkins Corinne Sachs. ahead. next Goldman with The go from is Please

Corinne Jenkins

straight you will everyone. Maybe priorities up clinical couple sort to guess. phase clinical some the moving even us, afternoon, soon XXXX a Good XXXX could from be the there through moderation. are of to large in with XX,XXX the drug you more without maintain patients long patients, thinking the and year? the is take stage understand the How than understanding just that One otherwise, be just help here to from phase and rationale I relevant at given Maybe three us one stable set the initiated through me earlier that steady And indication. from balance an therapy endpoints state. target stated as of you you PSP do for one, like get a expect doing profitability second that it the for two a talk will final being the had into on now you could for then or of program

Justin Klee

the probably as Justin it well. to over will question I and Corinne. take Sure I'll first Josh and turn then Jim and

we just timeline provided will us have XX,XXX take achieve So to not long on it how patients. a the

heavily reflects focused our that commonly are delivery there vision depending product getting to to with getting demonstrate medication the function really possible, we achievable us. of right the is become standard of the and that will I care. pathway on given on you the patients ALS goal quickly as benefit tell execution we patients that's feel both basically it the as And will so very first goal most on XX,XXX launch of Our are now, survival. that because used

Unidentified Company Representative

yes Jim. to, will I ahead maybe, over go turn And

Sorry.

James Frates

this We guide at Sorry stage one the Josh. next profitability. I on Corinne. not take to decided will

guiding we But in obviously, think I profitability, we'll revenue math that see guidance. the because hydraulics maintain that than in grow as So expenses, our can on not can we faster as you include terms the And long all able that's to be P&L. also profitability. essentially, of go will

importantly, think we we market is. out. we this highlights longer of really business that unique that's for the how the have ultimately, this have the to And it matter, launch, just I think recognize, have it's the in the I for ALS livery the went us opportunity and fact and term, driving the needs of data patients

the I well the and to because pipeline, neurodegenerative of But at a so we're I be how gonna So right, first get think Josh to continue all RELYVRIO the because to in in, our because to prepared making foremost, you. sustainable to Amylyx be a And is term focus us here remarks, market think going continue tried then there. one goal for therapy, driving to on is our we differentiates number term that's community. at our that I ALS me long we're and which time. we makes in long launch back fund We the we're three, in excited do outline real this And that's going, need companies our profitability is from other what don't to another there's in invest thing to can out a to diseases. business that of need back investors, business go how interest the also also lot to the seeing term. that's long

Josh Cohen

Thanks, Jim.

PSP. about talking so And

all we and randomized of placebo that to over should at an things the process is priority against last looking several for of some the years, study a the controlled progressive but to through company. we So a prioritize are we've And data look indication the those try importantly, shown I thing I were is outlined first for company criteria as I that, primary at PSP have select to highest supranuclear be to a that in palsy. share of indications what that gone the thought internally for already pathology think met most the we

excited And an so meant, just part our And the we're the add about to, what's the I of indication. exciting and as think as that's from as this driving long hearing KOL community making excitement PSP preclinical some But also supporting factors I constellation that of and also to us really makes there's us here. go data into think that's this that it's study. excited that

Unidentified Analyst

all. thanks Great,

Operator

is next Bitritto-Garg question Please from with ahead. Neena Citi. The go

Neena Bitritto-Garg

my taking question. for on the thanks congrats And Yes, update.

great. if to trying little terms in this can terms seeing there? talk So forms figure just just out seeing, so versus in can about of bolus, net bit trend And you're a or what talk you duration I'm of that'd seeing start curious that about dropouts far, on color any us you're the give any you therapy of you're then Thanks. be ads?

Justin Klee

Yes.

we the not double adds, guidance providing any just I'll net the for on our number we're So to, of again, back patients go think quarter patient they can't forever.

was that Again, bolus the to know, deliver because QX that up demand. So we initial when we we'll be over. be been will pent in lower in we've believe able QX, QX than don't

hard us So guidance it's that. for any give on to really

October, the the basically give launch first duration of beginning terms on in to early who too of started therapy, of of we're end November. In that it's mean, treatment, the at really I patients

give, clarification haven't they any for long on any, to enough really therapy been us So there.

of therapy Centaur are of months. as seen well. saw a discontinuation line with discontinuation six that's at with as line out And in similar haven't XX% Centaur we a In reminder, what about terms kind we rate tell roughly that you in with just is, of People long nothing the of we're law, trends there. rates, just been general sort that enough, can on I seeing

patients again, on really six for therapy haven't So, been months yet.

very So we're going that to closely. to continue monitor

Neena Bitritto-Garg

Thank helpful. you. Got it. That's

Justin Klee

welcome. are You

Operator

you [indiscernible] Goodman now. is Marc podium next The on are the question right

Marc Goodman

then the about Wolfram Thanks. hear. talk you second, just reason rationale data I the support for XXX? Can the couldn't And Hey, sorry, mechanism moving there. for And the study. the

Justin Klee

Sure.

first So XXX.

become called since years, otherwise, around several degeneration for injury that. And a pathway an find models pretty XXXXs, own the to digging that there's involved models calpain ALS. last axon is that or kind valerian in And, clear the activated whereby knock models to has shown and key both pathway be effective have studies So proteins is be of need stress. that over will occur. XXX of you'll axonal then into of inhibition which what been neuron response That's what degeneration proteins pathway antisense. and So the the that its to is calpain the is valerian X X in with X the And can XXX one on oligonucleotide calpain in there's pharmacology in knockout addition, that degeneration. targeting been preclinical pathway, in a destroy animal

And there's then And out to XX. a X ALS evidence Wolfram. linking biomarkers, finally, then calpain there TDP lot turning of including different

animal an data model we we phenotype, that said, together University, at Dr. of broadly, with the degree in we've as in four Journal saw of those [indiscernible] clinical what in in as of studied space years conference the last the disease. done and as broadly, cellular Wolfram, experiments Washington call the is investigation animal rescue well model. both both as Washington, least of work Much there. the the of And of models models is well So a disease, published some preclinical But insight. cellular the was as of

excited that I got that the that really forward there. So think was us to data go

Marc Goodman

Thanks.

Operator

is question [indiscernible] The ahead. Please from go Securities. next

Unidentified Analyst

on the patients? by the these related early sense on any used more being Hey, kind commercially Thanks for is Do if days and I monotherapy drug how twofold the questions distribution is a Any of commercial. maybe the just taking I And in then of whether congratulations And PSP results. you it's some be do I've thoughts combination? versus that, you three got on would have combination questions potential so afternoon. on phase great. first good its sense of is in pipeline what question new versus a percent And my related second had study. have the a pipeline. triple there could, two question. use in quarterly setting a

other the the to is B receptive seeing there able First, biomarker be the terms markers on how driven In one in work strategy anti in gives attempts in strategies? you the more Is PSP. of the very movement kind antibody. biomarker Thanks. And tau PSP? it seems And elements? part we're was is, driven neurodegenerative and in confidence light of an maybe momentum the just FDA with space? past, to open it'll be that to then in Is there that been that that, have some really of

Unidentified Company Representative

Yes.

So not question. use and I'll first whether or therapy, patient single products. And therapy really would broad of utilization the population. therapy, use we're combination mix broad say from seeing take available I or of three it's regarding really that your the to with a all combination very RELYVRIO mono a it's a

that patients with was in again, disease, many come see on taking and to diagnosed could diagnosed drug, it then as diagnosed or add all quarter to to continue been the well to take last is enrollment may they'll diagnosed and more switch time define of six this for just XX QX get been start it prescribed to policies ease last patients an from have for newly again, to days on say, a from have average. first because to the easily, as we get And expect all patients really we or this some to improve Again, perspective, in the up that patient months. drug the really who continue to board. would years access access use out as newly So re we I patients. with physicians really relive

Justin Klee

it. opinion protects we really safe shown while against AMXXXXX about canonical the neurodegenerative we've neurodegenerative progressive for yes, key PSP, neurodegeneration say, for cow the rationale leaders an thanks how think we are against the rapidly in PSP, of mean, PSP have preclinically, community been I another unsuccessful study. PSP. on a mean, I Greg, excited a PSP, It's oral, for significant reductions FDA disease. Justin. clinically, antibodies then then in in protein tau And the is they Alzheimer's first, were I in terms drug And this. show that And have associated with And the our still PSP approved that's That's very and apathy. there it's disease. RELYVRIO Yes I in would the question especially

PSP, key really it's and of that about to the and more we're we're of the us above I that excited about on to study starting importantly, leaders, probably excited the that. think But that terms continue more opinion In going study But today. design, makes so really the study. so get into not we'll all share

Unidentified Analyst

you. Thank

Operator

go comes Ananda Please question H.C. last The Wainwright. from with Ghosh ahead.

Ananda Ghosh

have Hi, quarter. PSP. I guys, questions congrats on on two the

trial, impacts one first insights? got tau never The or which is with downstream the how degeneration two the there we PSP similar with about do hear phase mechanism the concerning is, sent is in your is any the Is which pathway. And to AMXXXXX second

Justin Klee

Yes.

and on first ALS pathways. maybe So PSP their and degenerative

lot these still etiology for I all So, research think into pathology. exactly, there's a of the diseases, and both of of

well, death to the may tau. endoplasmic think I mitochondrial to is a that diseases is whereby terms as cell the literature, and then literature pathways, of of related our in we what target. both see and related which AMXXXXX lot pathways, reticulum on there's AMXXXXX, this view affect developed And significant

endoplasmic between So I stress. there's reticulum lot tau of a on think link literature and the

And seen in we've models so as preclinical this well both as there. including to are that's ones in something that placebo face study. randomized we've in published change But Alzheimer's our on focused that controlled tau

feel we a consistent robust pretty So, and, finding. that that's

Ananda Ghosh

Great. Thanks.

Operator

There questions comments. the further for you. Mr. Klee this to final back call at no turn are I'll time. Thank

Justin Klee

ALS. huge indication, well talked tolerated maybe but just quite to show excited a first quarter which we only about. mission of quarter the in need of We're us a you news, a safe reductions much ramp driven is well. that's Thank shown that unmet covered joining briefly, exciting the lot expanding likely and is in very really large probably our as in as with another significant really thing has achieved into all neurodegenerative this and And our already we as on afternoon. market U.S. and in for as be one commercial second U.S. the a which has we're product, said, company. We're tau. Canada profitability We clinical as and a disease, we And well other a proceeding launch been commercial

people We moving forward to and around well. both to allow going people and to have more diseases a to profitability have to hope ALS, people we the diseases. and more many us help as other more keep keep what's with is world, Achieving business many helping with neurodegenerative neurodegenerative help more and sustainable with

all you support, for much and you rest joining your and a for thank we great of So hope have us very your day.

Operator

presentation. The attending conference is concluded. Thank today's for now you

You may now disconnect.

Amylyx Pharmaceuticals (AMLX) 11 May 232023 Q1 Earnings call transcript