AMLX - Earnings call transcript Q2 2024 | Amylyx Pharmaceuticals, Inc.

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Operator

Good morning. My name is Kamil, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Amylyx Pharmaceuticals Second Quarter 2021 Earnings Conference Call. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please be advised that this call is being recorded at the company's request. to Relations call and like Allen, to now Investor Head, Communications. would turn over the Lindsay I Please proceed.

Lindsey Allen

Good morning, results. Financial our discuss and our our the and Chief today today Officer. Justin second us thank call and Dr. quarter you Klee, all Medical our XXXX Camille Josh Officer; Chief financial are With co-CEOs; on for me Cohen joining Bedrosian, to Frates, Jim

of remind call everyone information we are that and statements plans the Before like provisions the to XXXX. begin, are or this would and safe pursuant we are our of facts presented historical Private to on that based that Act I not make expectations statements Litigation current Securities made harbor any forward-looking are on beliefs, Reform

but thereof our to to, our include, statements statements any expressed developments expectations statements regulatory or limited forward-looking timing not implied AMXXXXX by cash avexitide, Actual differ the and and are expected and those respect and any regarding results from clinical AMXXXXX, statements. could and events materially regarding runway. thereof with impact These

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

over call Justin. I turn will Now the to

Justin Klee

for Good joining morning, you and thank all today. us

organization, serve. communities as important an treatment endocrine to the part have options and and over we goal months As we deliver to made neurodegenerative, of few mission past progress significant our our continued the neuroendocrine

receptor this diseases. hypoglycemia. of orphan in leads hyperinsulinemic and is key approved Avexitide in FDA Most late-stage indications. designation in to assets targeting a orphan asset of imbalance hypoglycemia, Phase therapy response diseases and is of with options. notably, with receptor drug X breakthrough last have antagonist we regulators now several avexitide response month, expanded with our underlies with and acquisition conditions pipeline treatment Avexitide The is glucose-insulin a the one no hyperinsulinemia our III-ready which GLP-X an the designation GLP-X

avexitide X hypoglycemia, indications characterized hyperinsulinemic by far, hypoglycemia, PBH, been So has studied in or post-bariatric hyperinsulinism. congenital and

is subpopulation orphan a PBH, who The the significant first have that affects condition people but indication, undergone bariatric surgery. of

on me ahead. little market the let elaborate Now a further opportunity

Despite performed bariatric and has receptor basis. on year, GLP-X an weight this XXX,XXX are continued procedures of the loss, agonist new every to than number more introduction grow for annual

Over past the common people approximately most undergone States types X Roux-en-Y years, the for gastric loss, weight XX sleeve X and in million the bypass United gastrectomy. have

of higher particularly procedure bariatric liver Experts expect substantial and results severity dysfunction cardiovascular BMIs. surgery and with weight the the a disease. highly sustained the risk of also metabolic for is cornerstone people suggests Evidence loss, events associated of weight-loss to effective given remain reduces that in therapy and surgery

can in cases, and years to estimate referenced, longer surgery. people some develop symptomatic This We to million I Turning post or PBH. in persistent in received people X people prior of U.S. have who X today, PBH. approximately surgery that the X% XXX,XXX bariatric condition X had even the

as PBH neuroglycopenia, of events activation and seizures, is hunger, of glucose tremors, impaired sweating, including is by and associated brain well characterized autonomic cognition, anxiety. with presenting loss as as starvation, Symptomatic system, consciousness the palpitations nervous hypoglycemic tingling, known

receptor in clearly PBH IIb and linked III of already for from to PBH. the first significance. associated Phase Phase events, primary levels, for low trials quarter Phase initiate agreement expect the for People II and development to plans FDA particularly for the avexitide, blood composite with next hypoglycemia in in the glucose that in Level we outcome, our crashes was X stabilize in is discuss outcome study reduction with antagonism avexitide The treatment Level met could a X PBH on the the which clinical will year. GLP-X of pivotal glucose the with living and Phase PDH. high helps is benefit dangerously III Camille of program There with

data, including recap significant the and clinically events. also will the Camille meaningful statistically key hypoglycemic reductions in

We in has X X, are that X demonstrated the the events been by hypoglycemic be avexitide.Avexitide than first-in-class highly Level receptor have greater and XX% potential encouraged the reductions by to antagonist. GLP-X

restructuring. quickly I completed turn I it quarter, like would to Before Camille, over runway. second we on In largely to cash our touch the our

We turn will Jim into I the expect now our call XXXX. cash runway over will Camille. additional to context. take provide to us

Camille Bedrosian

Justin. Thanks,

hyperinsulinemic PSP, our syndrome of and and Wolfram including ALS. AMXXXXX Now I supranuclear or palsy programs, in in X will AMXXXXX or hypoglycemia post-bariatric hypoglycemia briefly review in each avexitide and PBH, progressive

to and events. GLP-X designed levels. receptor hypoglycemia beta is glucose secretion demonstrated in by stabilizing Avexitide and clinical has islet pancreatic effect significant on in reductions of studied PBH. the from insulin GLP-X to mitigate bind Avexitide X hypoglycemic been in cells Data trials trials highly these to the block decreasing

efficacy composite and with our p-value Level be program XX-milligram hypoglycemic events dose, the outcome. X reduction hypoglycemic has Level a the showed events. with X agreed of trial Phase which we Level will in X.XXXX a Level of X.XXX. Phase in The X and notably, p-value X a Most reduction III of events on in XX% efficacy outcome study in Phase a XX% primary The a of hypoglycemic intend reduction IIb to primary this FDA in the III,

The pivotal P reproducibly program to X year. benefit We were month. QX of these conference by in Phase reviewed next statistically initiate safety significant and depth we supported values. planning PBH profile. a is in data, stabilization in levels, on our during Based on with are actively in trials these glucose call data of III insulin a last these are showed decreased track data additional and further PBH, avexitide achieved Furthermore, favorable while demonstrating which

sugar who of have who disabling seizure. live blood your familiar are especially Imagine bariatric not independently, PBH, without are driving symptoms. the the those can and of you have you to drops surgery. people on affects and realizing For undergone condition it, a Symptomatic ability you quality life you effects and neuroglycopenic PBH with have

could a so call relative faint Or could you potentially to sustained they suspended. move injure cognition due forced your XXX time, can you if because provide to a lose or license being be As impaired fall have assistance you low at mid-career retire friend or immediate consciousness and Imagine in glucose. because and yourself. any have you to result with

unexpected or modifications drops with These examples for could economic and PBH. therapies health, blood glucose, dietary are create which best the very experiences medications. that of individuals use and are that in mitigate efforts might individuals despite off-label their the social problematic XXX,XXX can current symptomatic we issues that other reality PBH the estimate with living with shared. from These is benefit This people currently living have

the PBH unmet avexitide contribute We significant the clinical our program the coupled excitement believe robust with among need, endocrinologists. data PBH to in about

our program participants enroll possible that in Phase promptly we III program to line such work data as be XXXX. in will from top as share will We to the a in position

Wolfram Adolescent including the the week for week data Diabetes for fall. forward HELIOS turning to time week that data longer-term participants We trial top International at the at to Now at who program. line Conference XX participants XX, or Society XX and presenting the XX have syndrome their this Pediatric look visit available in for all reached

and provide and FDA, the trial, including planning once finalized. clinical details for Phase more stakeholders, with engaging are we'll a III single We

and our syndrome. the reminder, vivo in trial glycemic, control in These model promising outcomes, a highly significant in April. global and presented were including Wolfram of recapitulated of results as has WFSX impression As as benefits of knockout glycemic extended Wolfram, shown data AMXXXXX well in and on clinical mouse change glycemic optic

neurodegenerative disease. a is progressive that syndrome Recall Wolfram

across While these had progression, we fact, anticipated suggested of even outcomes. data slowing the or this improvement in stabilization

turning ORION Now PSP program. to well. is Enrollment in going the the study

As to described describe a mid-XXXX. data analysis interim bit the conduct would detail. like previously, ORION we we and planned an analysis have share I more to intend in of in

We have operationally an study IIb/III seamless design. introduced Phase

to people part Mid-XXXX, will XX participants. with line an analysis first living top week of plan XXX data include through these adopt unblinded The for PSP. approximately we

to will In resources. into available to also on portion participants seamlessly a mixed be addition, study, have goal the second proceeded reprioritize our data allow will or us of encourage us analyzed. will Strong The move who analysis the decision. this XX to the beyond go-no-go whereas negative is data inform data of weeks

shown tau a Alzheimer's study CSF As in in randomized controlled in has highly of a significant reductions AMXXXXX disease. placebo reminder,

we is have studied tau with with a and disease, the affect to taupathology previously large significant intracellular believe tau a in the first potential and a to variants pathology. PSP tauopathy intracellular be human discussed, agent and between As samples. tau, we trial highly it in believed genetic the clear impact to link is with and is AMXXXXX

involved or the program in testing We end a AMXXXXX specifically to our to plan oligonucleotide, ASO, degeneration track. remains is of clinical an neurofilament Finally, inhibit calpain-X, and begin protein before the biology. year. designed axonal AMXXXXX on antisense

biological dose in placebo-controlled planning a this of to the to study and are study ALS ascending in the AMXXXXX. activity evaluate We agent multiple safety

At is are of Amylyx believe track programs, significantly we on these so. we diseases X goal our need. do unmet And to impact to with

to turn Jim? I will now the over call Jim.

James Frates

Camille. Thanks,

restructured and results, on us quickly, cash us placed strong to meaningful in PHOENIX enables which we line milestones. near-term top our Following position focus a clinical

QX in We and investments. $XXX.X cash ended with million

we programs. purchase have we to acquired focus our avexitide reminder, $XX.X our targeted major price million. early QX a for clinical in acquisition, Since As on the a budget of

data to us avexitide II into trial the from data top company the the namely readouts, AMXXXXX readout manage Phase in program, our believe HELIOS line program will data interim will from result work, clinical PSP clinical take from readout the this a we As our program. of interim we our of our Wolfram from meaningful cash work and and data III Phase the syndrome, readout through XXXX,

revenue we our financial net second our Now quarter was to our the to estimates. turning to results. million of once stopped due sales. This other reserve adjustments mainly details negative driven was adjustments by to for our for product returns $X estimates revenue Net gross to

sales for QX supply established moving manufacturing the for same results any were We quarter from future period under RELYVRIO Cost to COGS compared Cost commercial firm related were losses on $X.X PHOENIX. to this for prior estimated and XXXX. in sales primarily commitments to the production of material million not and do $X.X expect ALBRIOZA agreements for of were million that forward.

a in PHOENIX expenses million of due expense and period XXXX. to as in was The and were outcome same restructuring result decline a and our the million for trial. to personnel-related a $XX for the to quarter decrease decrease the due primarily Research costs clinical in of compared development $XX.X payroll the

marketing as the $XX.X in quarter general decline in were voluntarily QX million million charge benefits and period this XXXX. was employee that million severance was decrease decrease Consistent compared paid for in with we a expenses R&D in $XX to same professional our into period of a on $XX.X X RELYVRIO and prior total and million was plan were SG&A combined spend of the cash discontinue per completed quarter. the to The QX, following services to will in XXXX, same and decision the we ALBRIOZA. Restructuring in expense payroll expect and for majority restructuring quarter. consulting of costs termination-related related is range our to due this in largely move $XX.X the personnel-related our and to and primarily be for Selling, expectations, $XX The million in compared to and administrative XXXX.

the quarter, per the believe in $XX.X milestones restructuring we today. our position clinical we're deliver to $X.XX financial the loss share, that million recorded a we in Finally, and of a outlined on charges. second solid ability or in Overall, net including

remarks. to Josh over the provide to I'll closing call some now turn

Joshua Cohen

Jim. you, Phase Avexitide in the has we beginning milestones poised X quarter to advance are orphan both designation III development is path and ahead. drug first and into pipeline about and breakthrough closing, PBH in upcoming of therapy Thank FDA programs, designation XXXX. our excited In

who for data week In week in at the that their data time. XX XX top the Wolfram including participants have we longer-term syndrome, for visit expect available participants at XX, all or fall XX line reached from HELIOS

Phase are engaging a We planning III FDA trial. and stakeholders the clinical other for and single

is We will provide more finalized. the design once the trial details on

is look and and resources AMXXXXX be AMXXXXX keeping and later we on of need. work from diseases to in our with in upon this And team expect track in ALS trial as PSP updated orphan studied believe well, unmet to clinical the neurodegenerative, analysis data recruiting mid interim have next We ORION an X place deliver to neuroendocrine ahead. critical we readouts on continue living year. to we endocrine people in with is meaningful you year. forward The high data build we

call Now would up I the open like for Thank Q&A. to you.

Operator

will We from of Your the begin America. session. from Instructions] now comes first Q&A the [Operator Charlie of question Bank Yang line

Chen Yang

of of terms PSP the about ask year kind over the is final to of of guess, there? there and a assuming needed next to this -- if the mid adjustment a then wanted patients readout? amplify make to observed, trial an data there's there is just I to success number in signal kind And of as Great. path in further a potential expectation the I I'm the

Camille Bedrosian

Thank This Camille. is Charlie. Yes. you,

our XXX in at to study indicated placebo first do a participants the part we and versus prepared about remarks, will weeks, XX As we and we their full-on Phase IIb, longer-term as XX well. is of have who those -- the the analyze beyond AMXXXXX analysis will where data unblinded weeks for at gone look the

size based the we be the seamlessly will will study. proceed strong, we III data, final based positive, those sample And determined. and result, then And on on that if of portion -- will into Phase the

Chen Yang

in Europe, to U.S? Wolfram follow-up is the going that terms And just of how to just Great. compare one in maybe opportunity quick the

Camille Bedrosian

Yes.

endocrinologists are certainly with population. from and a of who we relatively Wolfram large, are speaking, familiar aware So Wolfram have

are right the So -- but now, on focusing U.S. we

we so so yes, And more on more do -- as that research. we do come to

Joshua Cohen

add tool syndrome from that all a around being would people do we I world. see monogenic Wolfram at disease, the But

much So a global unmet is need. it very

Operator

the comes Goldman. of from Johnson from Your next Corrine line question

Unknown

us This X Balek on PSP is from for front. Corinne. the

The interim to then the population XX-week history thinking threshold first endpoint are XX-week terms PSP studies suggests for analysis? in of natural the for prior And about the in the placebo thing, point? at the time at what in was, futility second you and what

Camille Bedrosian

Yes.

but in show alluding, the that were reproducible. a III of Phase studies are relatively There in is progression rate. of a as active none benefit of there PSP. disease the drug, large you reproducible Unfortunately, was it quite relatively showed similar fact, actually So we X did deterioration which the at

use data and do basis that up. at the coming we understanding for a So as looking

Joshua Cohen

data. not the for this of on as full futility, too, And your formal a other evaluation threshold analysis. the doing question, futility is a We're

a we'll do analysis. a So essentially be kind we when Phase release, looking of top interim line IIb release full at that

point rate a at usually Camille's PSP, quite been just highlighting consistent, studies you larger have the placebo-controlled just the randomized conducted is when as point under And actually in past well, strikingly look month. at that placebo X

Operator

comes line Raffat next question Evercore. from Umer Your from the of

Unknown

trial, placebo-controlled? the year? does data I planning timing secondly, II for Phase to Phase This III it it [inaudible] firstly, Umar. for XXXX, is on as need guess, to be between for you incremental update interim syndrome Wolfram data maybe Wolfram Phase And next III this are the progresses, give trial fall and PSP

Camille Bedrosian

Right.

So thank for is you Camille. This questions. the

prepared Wolfram, Regarding share stakeholders that finalized, once those of with in are our we plans FDA. engaging as course, we'll the And you. include, indicated are our remarks, we with

gone through later fall, and a XX. those on this reminder, and XX weeks data longer-term additional XX we as share participants who will for individuals have Just data week all XX through

as readouts those to forward looking we're well. So

individuals study end more types with of able the be through we'll sharing then study in And multiple And the our dose to progresses, by as we data provide to ALS we'll as and initiate regarding year. we detailed be timing XXXX planning are ascending of indicated, XXXX. the

Operator

line from Suvannavejh comes question Mizuho Group. from next Graig Financial the Your of

Charles Wayne

Greg. This interim Wayne this year? is wondering will of expect HELIOS. you the on for readout Charles similar data present be type presentation to updated were Should to it We what earlier at we data the for

Camille Bedrosian

Indeed, individuals and and sharing provide weeks the intend to as again. you April we who data, details data XX top look we key so all international Camille at primary through line endpoints, as is with to This meeting. those in year, It's secondary you. upcoming data whom XX endpoint for of participants. Thank reported for longer-term this those Yes. we well about do -- forward

Operator

comes Leerink Marc Your line from the next question Goodman Partners. from of

Unknown

Mark. moving build This on expenses forward is to going What into Can with the pipeline Rudy external XXXX? is internal talk both line for you about and strategy R&D assets? the your

James Frates

you. Thank Yes. It's Jim.

restructuring line, as opens right, up find room really of one and down, Qs, think Phase in winds the our has in going spending is historically happening as those you have our on. that on we II expenses and detail the new R&D the for that some occurred large our of can I things some PHOENIX that

study move Wolfram as going to really And be is study starting to to range PSP up the growing. is where into currently, that's consistent ongoing. opposed a The

forward room spend And we so that leaves on move us the to as XXX study and the avexitide program. new

overall, a to excluding million And range R&D then $XX for we as comp SG&A. expense, just and of we the cash expect outlined, to be both million that's quarter in $XX now noncash

So into that's moving going parts the how are some XXXX. of

Operator

the comes from of Baird. Joel Beatty line Your next question from

Joel Beatty

does to the that And gives frame? this time get around analysis, around completing you end data that the interim what around PSP mean trial of on mid-XXXX, enrollment year? the confidence For enrollment completing

Camille Bedrosian

Joel, this is Camille.

enrolling in are towards time remarks, we more and We our having data tracking frame. we're prepared mid-XXXX. that as give indicated I well, quite We'll as toward information march

Joel Beatty

then do any And follow-up, of anticipate more as acquisitions after the acquisition avexitide? a recent you

Joshua Cohen

clinical time we've that Today, ongoing Yes. always say focus. have assets and we requisite many into -- I'll and scientific and commercial excited things wouldn't well and at. the path that's pipeline today, forward. where our we're -- our have rule we're about for fit and I'd wouldn't had a process additional for But they adding out we we the evaluating looking, some very assets say whether we're

Operator

There are no call Klee. questions back to Mr. I'll at the this time. further turn

Justin Klee

financial joining call a our today for day. discuss Have to today's you results. on Thank quarter XXXX us second great

Operator

Thank Please joining for you. call. lines. today's disconnect your Thank you

Amylyx Pharmaceuticals (AMLX) 8 Aug 242024 Q2 Earnings call transcript