ARVN - Earnings call transcript Q3 2024

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Operator

Thank you for standing by. At this time, I would like to welcome everyone to Arvinas Third Quarter 2024 Earnings Call. [Operator Instructions] I will now turn the conference over to Jeff Boyle. Please go ahead.

Jeff Boyle

Good morning, everyone, and thank you for joining us. of a and with can a in Investor issued XXXX third be we arvinas.com. the results at financial corporate section today, press our release quarter accessed Earlier website our update, which

Joining call. the Arvinas' Officer, Chief Officer; and for President, Officer, Financial Medical Q&A John Officer. Noah of Chief our Andrew the Chief will Chief Berkowitz, Scientific Executive Chairperson; and today call are Houston, Saik, the Angela portion Cacace, join

you remind assumptions. that discussion we outlined begin, with to Before and Commission, involve in and want forward-looking the contain uncertainties, in and Exchange read. that filings which These today's statements Company's release I will are recent I the Securities to today's urge risks, press factors you

materially on and President, may is call what the turn results today's now John? to actual John our discussed over Our differ Houston, call. I'll Chairperson. CEO, from

John Houston

our us conference Thanks, call. you for Jeff. joining everyone, thank Good inaugural earnings and for morning,

years now, the the cusp readout So why ahead or our as on await and are are huge X exciting we truly first have by XXXX. XXXX of data we IPO? calls first of we us, year of coming starting some we a pivotal end Well, for after of company the transition earnings the a our quarter

stage diseases. to robust a indications. commercial a neurodegenerative addition, we move class and of as significant to of approach the our organization providing we progress several pipeline commercialize of with updates across make goal becoming develop, forward we to cancers and new quarter continue to medicines In with look closer a a multi-product discover, each novel treatment now for Actually,

morning. to lot discuss a have We this

mentioned, with PROTAC other like our Andrew an of our combined And treatments. begin some as Noah our opening platform, we of towards quarter we'll of then joined metastatic provide pipeline. will believe both will as have Cacace. In and discuss vepdeg highlights. I finally, of confidence our remarks, the discovery to covering. monotherapy, a breast taken vepdeg our VERITAC-X our by and is will strides overview expectations will ability serious brief we the the including Scientific Chief overview vepdegestrant So years with an be our call we combination the Angela the I'll improve topics of opportunity update Jeff Officer, the mission founding, closing for Q&A for in or an our cancer XX to before of provide patients overview third what Arvinas, would on the when, I major with diseases. financial a for add be lives provide an trial and overview since

able PROteolysis natural system Chimeras to selectively and protein platform or efficiently Our some has degradation enabled disposal pipeline disease degrade remove Targeting of most PROTAC. degraders readout are and protein to bioavailable and we'll have data cross for industry. These the drug-like in with significant in ever degradation the needed, breakthroughs blood-brain properties Phase PROTAC protein the degraders to been have X in soon, that exciting proteolysis pipeline, designing when harness of breakthroughs the proteins. our create body's an Very orally the first designed driving barrier. protein targeted hand causing to include groundbreaking us This

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disease trial This as reminder, with targeting developed trial both multi-center open we therapy PROTAC, breast will fulvestrant ER X As next XXXX vepdeg Pfizer, a and from Together the breast patients positive/HERX generation data cancer is potential ever label collaboration prior other the first event with trial. monotherapy treatment entered negative landmark in in a a readout backbone combination we agreement of a of endocrine-based choice for be global in this with vepdeg ER Arvinas. the cancer for therapies. Phase with X advanced commercialized versus whose VERITAC-X clinical randomized trial progressed of after and XX/XX advanced as disease. The initiated in Pfizer, a with pivotal Phase

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data in ongoing of inhibitors, with and earlier for neuroscience the The poster to this Pfizer's agents, umbrella TACTIVE-U a abemaciclib continues the Additionally, which presenting exciting ribociclib combination turn at year. look approved in to in with see inhibitor selective TACTIVE-K combination to atirmociclib Antonio Symposium is forward oncology CDKX later patients. I now targets. Cancer stage across We evaluating we the trial, will potential other where we trial. Phase PROTAC Breast enroll San evaluating opportunities in including and programs continue TACTIVE-U vepdeg the abemaciclib vepdeg Phase sub-study Xb/X CDKX/X Xb from initial our

degraders especially given suited, well are of drawbacks area the an is of neuroscience oligonucleotides. unique potential and antibodies like drug First, modalities where particularly the other properties PROTAC antisense

to novel target neuroscience advanced the most a ARV-XXX multi-domain barrier leucine-rich is Our LRRKX, cross blood-brain designed or repeat program, is and X PROTAC kinase. which large scaffolding kinase oral a

that initiated will shown CSF shown cross safety to from in deep primarily observed LRRKX of ARV-XXX incredibly nervous forward LRRKX neurodegenerative intend Phase ability strong in a We in X to trial learnings blood-brain the achieves to humans. of primates. dosing LRRKX We've data where and by sharing genetic and degrade the year, disease-relevant also showing healthy for LRRKX in we central improved need but establish diseases. The studies. We explore disease. Earlier X valuable a unmet pathology of this movement degradation brain trial to progressing are barrier of inhibitors biomarkers the the the differentiation from Phase ARV-XXX non-human clinical faster of address severe ARV-XXX, in establish will neurodegenerative that on periphery We penetration preclinical dysfunction Parkinson's in in in as designed region of ARV-XXX ARV-XXX volunteers. strive of LRRKX with to This contribute fluid in the we also first-in-human degradation implicating LRRKX the disease, have trial and and system in high to look palsy, Progressive disorders is the disease X a ARV-XXX to disease effects lysosomal with dysregulation. potential supranuclear the to be initial linked XXXX. this X Phase to has ongoing measure or cerebrospinal been and link

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clinical Turning third program. now our to

of preclinical non-Hodgkin We X somatic our lymphomas. the and B-cell lymphomas. BCLX. proliferation which The protein terminal BCLX PROTAC-mediated a are traditional B-cell gene pleased damage recombination of transcriptional protein rapid has with checkpoints, differentiation, in undruggable cell and through cycle of apoptosis, PROTAC the ARV-XXX, lymphoma or of repressor designed profile DNA facilitates to of of degrade degradation repression overcome types BCLX, become also nature several tolerance a B-cell the the major to potential dysregulated the and response, driver

look forward next updating with Phase patients recruiting X trial on clinical of and a our lymphoma year. We in are ARV-XXX you non-Hodgkin progress to

a drug to major Finally, file in prognosis oncogene our GXXD application XXXX KRAS is standards new we for are is and of to in KRAS and tumor care. driver poor types associated with preparing resistance several investigational an program.

We Noah I'll program. this look the the about of as program. With we pan-KRAS to promising more are novel turn progress also detailed to developing more degrader sharing over overview vepdeg a Noah? forward and that, this for call a

Noah Berkowitz

happy with good program. and progress to our Pfizer, made update partner, we everyone. on and John, I'm provide vepdeg morning, Thanks, an our the have

availability line second-line by progression-free is quarter our in of endocrine on top cancer. will and is driven subpopulation. PFS combination Phase with in has or The compared We received need accumulation experience in of and positive/HERX X with excited the co-primary has even with the Also breast which positive/HERX therapy of high PFS assessed on discuss VERITAC-X of for the ITT option the efficacy blinded patients. me in trial patients first therapies PFS XXXX with breast with available negative is and treatment preferred life. why This will most tolerability ER advances become of superior few note administration options, initiating Despite support valuable a becoming treatment. it could endpoints, disease adversely plus trial, have ER central backbone in or enrolled track quality the safety within a of vepdeg, previously by the the the vepdeg route as setting, population, best-in-class the trial of vepdeg treat affect tolerability, The timing is patients and advanced survival by or metastatic potential a believe and XXXX and treatment with efficacy and be evaluating physicians into of ESRX a move VERITAC-X progression VERITAC-X for their multiple of events. the patient's I'm end patients fulvestrant therapies, progressed the the still that negative independent CDKX/X to to intention PFS readout X data cancer. may inhibitors and Let to and of ER-targeting a recent first medical review. therapy. which there mutations a unmet in late-line months

Secondary life survival, and outcome measures and including of activity, response, quality benefit include overall assessments. antitumor safety of response, and clinical rate duration objective

and a of both limited benefit Although over to with VERITAC-X median experienced of has has recently patients is received with progress breast prior a been ESRX mutations inhibitor X.X made an approved PFS and designed patients in has months. oral approval and treatment fulvestrant CDKX/X in study metastatic ITT The who CDKX/X demonstrate agent cancer have important of inhibitors, in most the was mutant the shown treatment subpopulations. patients ESRX vepdeg for to

result to for the in regulatory forward to sharing a establishing the months vepdeg as submitting to show PROTAC data study approval the degrader for choice. authorities. and we meaningful on first of and discuss this Based a coming improvement of may expect successful, our in health backbone trial. design, a as step this expectations the If act our line top over review We let's fulvestrant. therapy Now look in ER first-ever VERITAC-X

from Phase to and and studies in addition mentioned, setting other we Phase will plus Pfizer X the combination inform the feedback. second-line as is data One to start potential is several In design evaluate first-line to the VERITAC-X anticipate regulatory that of the John the trial, in setting. XXXX, trials X the continue additional we pending

initial will vepdeg of other both agents standard show at and PK safety in enrollment efficacy TACTIVE-K these manageable combined be preliminary of vepdeg. that can Antonio doses VERITAC-X care study the our cancer combination to which TACTIVE-U, Cancer vepdeg reinforce to TACTIVE-U, San full the will is lead-in early combination agents combination that to portion will abemaciclib will of potential the decision of and be December. breast about year. the data of Breast at believe ribociclib the We data from We sub-studies Symposium from and evaluate will and anticipate used presented safety profile data from data within and ongoing, available agents. With inform be in be a the Preliminary the we with respect with next

We choice. as these potential of data vepdeg's therapy show expect ER will an further backbone

the from Phase this believe both treatment in year, provide trial, Andrew for options. With CDKX now which as efficacy of making inhibitor, first-line Pfizer's in who X potential evaluating a plus We atirmociclib. call novel use has combination forward look which are turn Pfizer also tolerability, evaluating design to with need vepdeg the setting. Overall, and cancer for review progress data patients new we of Andrew? trial and Phase over a our inform superior We TACTIVE-K I'll trial our that, is will the breast monotherapy to to and are financials. in X/X the we of later this in to the vepdeg's

Andrew Saik

pleased ended I'm XXXX. to highlights XXth, share financial third for September the quarter Noah. Thanks,

results in the are release issued third reminder, a detailed As we included financial morning. quarter for press this the

our progress we us promising Phase equivalents, in cash, advancing readout, Phase vepdeg's objectives, position balance preparing cash support $X.X end of expected a commercial starting operations securities cash marketable our hand to key strategic sheet. program, X first are into At and degraders. in our and billion the for strong which near including year, product of programs the PROTAC we As progressing of of next QX, This trial later our all allows launch portfolio first X sufficient include the on clinical our had X we financial with XXXX. on a to

turn financial now to the highlights from third quarter. me Let

compared of due Vepdeg third by from same the During quarter quarter, primarily for in of $X.X offset we million. General with revenue. expenses $XX.X in decrease compared the $XXX.X license million The to and $XX.X Pfizer in revenue to to $X.X and million of termination the $XX.X of personnel recorded million XXXX. a partially increase a College XXXX. million with revenue million the Novartis in million million was lease offset the in the of Bayer increase as from office expenses primarily of That was in revenue compared million decrease million, million Collaboration for in $X agreement of as period due decrease revenue same the of in of The period was were million, Agreement million laboratory The same in period $XX.X administrative to for million from XXXX. in and $X infrastructure-related XXX and primarily million. Research to increase expenses the $XX.X space $XX.X $XX.X of by Street our were the well and quarter due development costs increase personnel-related in increases expenses third in a to of is an $X.X program-related $X.X million. $XX.X $XX.X

call sheet I'm that, over investments for back closing a year John? that on balance and focused pivotal embark the remarks. strong making programs us to will enable meaningful are John turn in for our we we strategic differentiated. Arvinas, patients truly And As objectives. With are I'll accomplish that on to our confident to

John Houston

time an Thanks, for Andrew. Arvinas. exciting is This clearly

on with commercial an trial ER organization as to the leadership therapy therapeutic breast Pfizer, VERITAC-X with vepdeg next to the By and step pipeline establishing potentially that setting therapy, a another an second-line into Phase vepdeg breast the treated second-line are as year, are as strong a stage plus we colleagues treated with monotherapy We patients an few top believe establishing data year, way ready change for treatment. plus at nearly monotherapy need metastatic new bring foundation most in receiving combination as thousands well upcoming patients XX,XXX in areas. line with are cancer will X first-line cancer multiple monotherapy our from X/X our patients the breast part approximately of setting, advanced backbone these patients other exceptional In positive/HERX breast team their the lay experienced across of first receive many of to an and the the In treatments. Every cancer. patients first have XX,XXX the paradigm we becoming in in setting, rich treatments. have over vepdeg of ER a of the to with to be with stand opportunity ER in years, and every who a negative treatment treatment. leaders partnership cancer We will

In vepdeg, our of addition to engine. broad we and advancing areas, pipeline therapeutic are several including across a discovery hematology product with candidates PROTAC neurology

physicians at in our partners questions, your and the the like hard to dedicated and cancer are thank to opening breast Arvinas who patients would participating the passion they our I day. in call Pfizer bring work and our every thank Before team and clinical I'd to talented trials. like for also

would like I'll now Our our not Q&A turn lastly, And be for to support. With call over possible commitment. to continued call. the progress the to thank our without their Jeff of their that, Jeff? I'd shareholders begin portion

Jeff Boyle

Thanks, John.

to the able sure cycle rejoin for any with questions. operator, you appropriate Before the yourself per up And to the give please question limit you Feel that I X are everyone. turn to free queue to I'll to time we operator, open follow-up call that, the make to ask queue? can over

Operator

Tewari from And [Operator question of the Instructions] first line Akash with comes Jefferies. your

Unknown Analyst

is This Akash. in for Manoj

be also the if all [indiscernible]? their at be only better any So with IBRANCE CDKX with other for inhibition should studies Why Pfizer that would first-line, base vepdeg, just used your investors' combination combo CDKX one, but moves meaningfully the for shows in not CDKX/X or case second-line? pivotal the

John Houston

you Thanks the just of question. for Could the beginning question? repeat the

Unknown Analyst

the be base the with first-line in second-line? the like CDKX moves inhibitor and Pfizer combo with vepdeg case Should

John Houston

-- CDKX be the should our or in so be see, I vepdegestrant. should case plus you're whether asking not base first-line

Unknown Analyst

Yes.

John Houston

all, on our is our the excited question. it's Yes. of fact about doorstep. data a we're first right very And great No, clearly, that

atirmociclib. beginning a have that's this data. also we We're asset. exciting end year, that combination by So the have excited of very next by year, of with our the a fact we'll ongoing pivotal Clearly,

and tells But think ongoing if is step with very our end the be with is would think excited. next would Pfizer, great the But combination yes, that data be this combination palbociclib We we got obviously, CDKX/vepdegestrant that the to year and forward. have I one. I year if up I decisions partner, that will the combination. data right combination. allow data choosing make very Pfizer a think us the that with We'll excited we be that us we've

Operator

comes line with Brad the from question Canino Next of Stifel.

Bradley Canino

on Question combo help the for data. you combo rates, presented relative palbo last data frame me the abemaciclib you the XX-month response PFS, Could upcoming to that you year where strong ESRX expectation will in these activity over the quarters be Phase you next and Is both the about bar we combos in pretreated CDK think populations? mutant several Xb that that wild-type? additional as had unveiling

John Houston

patients with Yes. very, a data in Noah see about to you XX% trial I'm to CDKX/X very XX% with Thanks. of and palbo had that In the data, when over Great to Clearly, set didn't. then The our patients this experienced. question. this second. abemaciclib, combination. set, were we data post CDKX/X. XXX% was remember were going hand that that is CDKX/X is excited not XXX% this it thing

some caveat, comments. to I'll So ask with just make that Noah

Noah Berkowitz

Sure.

reported of the last So we the when had year to benefit have palbo/vepdeg patients. long combination of follow-up the results we

safety response referenced rate and suggested, population. in you to were there. that And addition, look median But at in I observed we the so as we think you why PFS that's able

about presenting but data I to as would can smaller view of CBR even can you profile, abemaciclib inform with a be at mature include set data and that ]. of which safety that response things So larger of and that can shorter further be recently actually the drug, which and will will follow-up the we're [ looking similar then top the a more the patients rate, on And treated this type set set efficacy it, data like for make comparison. then going from

Operator

of from line question Darout comes the Next Capital with BMO Etzer Markets.

Etzer Darout

the there's control expectations? fulvestrant for could think that sort incremental VERITAC-X? maybe around through sort could on question frame it we questions can and Anything arm actually on you perform lands expectations upcoming of, your sets your arm And you around data anything the a do sort We've Lilly where read of that? -- VERITAC-X. to if for around that of control Just where how of sort gotten

John Houston

be be kind EMBER-X CDKX/X how to based detail terms some care, the we the to Yes. just there. answer able say handing VERITAC-X anything to data of at populations superior also comes still trial be to want will give and XXX% you fulvestrant, question. of be Noah And fulvestrant to do want design EMBER-X what at it comparison. Noah, clearly, different show of Clearly, we might we over Great the and And out. look at of data patients. was be to I'll able see And to again, Lilly that in be to excited VERITAC-X do? there. it control the to our about We're standard which arm to you is like-for-like design more is. look the when what very want compared able to that when the data, was do to be can you may that fulvestrant. look our experienced And now patient Again, show will on

Noah Berkowitz

John, Sure. question. thanks Thanks, for the and

difficult, fulvestrant going see to -- to it's arm. obviously, we overall, what So from predict we're exactly the

the the that patients study. given in in that what and expect somewhere what was be study have in postMONARCH treatment it observed was observed experienced, between We will EMERALD prior the

the like the could looking There not and combination you in we'll we and what is arm. it part study. in at know we your to range. hope that don't the population. is vepdeg exposed the in safety what -- we few patient also what So it see who of some your that. that would is CDKX/X second X-X looks terms to expect expect from What by patients a be EMBER-X, somewhere question about better at enrolled And the comparison, look months in exactly of be And be to of tolerability EMBER-X, month criteria -- inclusion were when would for for

So to draw we'd comparison the understand results have CDKX/X prior any to in exposure study. our of context the to

Operator

of Ellie with comes question UBS. Merle from the Next line

Eliana Merle

So into then the you is reasons if you And sort review thinking be successful? do of are PFS the think across broader potential success minimum able non-ESRX patients? and for could population? success VERITAC-X, what to I think threshold non-ESRX that guess here could how the about be you to get you the in And for ESRX on this label this

John Houston

have are And tumors that's great population handing tumors Ellie, vepdegestrant. XX% of part wild-type again, fighting And there's then ESRX react of got who we against second-line Obviously, of are a think over be will that mutation. I'll question. answer. biology patients Thanks, that the And population, by a with to to able other slice have be in significant Clearly, and patients the sensitive. a around we large also the still the well Noah to patient think of We for specific driven mutations. this the group disease disease. driving endocrine of that patient is plus

So just biology against. of that there's remember about? do But to you be fighting that Noah, we're that yes, the disease there specific want

Noah Berkowitz

the would we study. ESRX endpoints at looking Sure. you it, have addressed know, that the say there but Not to think I as population. is, mutant expectation and lot our We're ITT because add a you I co-primary in

our we're those to going successful be that So is primary expectation with endpoints.

ESRX though we regulatory regulatory non-mutated type to their at would been might And analysis, that the precedent is have mutations of we'll post than of, driver don't be powered some be to at that's approved that population anything underlying biology the else bodies still hoc I that benefit, those have that assume and them. subpopulation would that patients as sensitive outlined, endocrine not Our for responsiveness we bodies. What with will is more and though, are believe set what many that's will alternative to see, for the you in that mutant I'd because see want some be limit do looking would vepdegestrant. remind of is because the the patients base to some the would be successful, study John wild-type want We population. it case

for pretty remain can mutant So result and population. ITT we confident positive a ESRX that for see the we

Operator

question Next Archila line Fargo. Derek with from the comes Wells of

Unknown Analyst

Can patients you ] This both market and from for the Derek. mutant the patients? frame wild-type? there hit little And only is in mutant you maybe in [ ESRX stat you there? if work for vepdeg, us. One sig bit help any what Elane hit ESRX Are assuming a good

John Houston

Yes. monotherapy, Thanks opportunity clearly, into move specifically a question. think for bigger here, combination. and the first-line there's combination we as second-line And even for then we significant opportunity

receive said the of getting part an those treatment. I patients X/X treated earlier, about think are as XX,XXX setting. now, as And ER breast I setting, treatment. first-line nearly the majority metastatic right in their with patients of And will therapy of And it's are year. the another cancer second-line are in then them monotherapy patients XX,XXX every diagnosed

potentially the believe to plus us potential vepdegestrant cancer. establishing of and change of game in as we lay that a the And So opportunity setting grow that paradigm to will second-line the course, treatment its in PFS show for plan patients the give monotherapy those combination a breast we negative ER with thousands line of if can we opportunity therapies, got many believe positive/HERX monotherapy have can significantly. foundation that we

Noah Berkowitz

mentioned wanted ESRX one the addressing just you had sig market mutant. stat underlying question, for comment, offer and wild-type to but not I for

that ITT We're make remind wanted sure not ESRX doing wanted wild-type we'll to the be doing for the I on clear. and subset to stats population. statistics the was study of at and again, So design just mutant our the look the I for to is that ITT population.

Operator

Cantor. question with Li Next the from comes line Watsek of

Li Wang Watsek

combo you nail X the a bit how if still wondering design? before little elaborate trials the I data of And dependent the you that that is for final second-line, on need need still Phase regulatory that inputs generate? the can key front-line guess on in and down you much you to

John Houston

want for second-line first-line Yes, talk to path do the for terms thinking question the of question. the you key is regulatory you and combos. forward about Thank that? our the to in Noah,

Noah Berkowitz

again, ahead of are So these us.

planning you're second those results, we after the first is for head line. of expecting the think into next I VERITAC-X So a combinations Each we're which year QX, QX, in for to, that requires which alluding discussion. authority and health

first-line, You've opportunity very a palbo. excited seen our we're moment be looking in the with another that inhibitor. And in atirmo. heard second-line ago we -- CDKX/X that we with CDKX, atirmo and combine also we're combine that that or combining shared about in our to palbo with in and/or guidance we've And a can conversation we'd if

there considerations be for these studies. are -- each -- -- it different the of those depends on for comparator is each. So in arm what will It

We that. haven't announced

So that believe be a that there the first-line, probably point the conversation a X population agents. data exact about we those us navigate the with that get discussion. of that's using discussion into in And to what that's lot chosen. in doubt contribution if patient would there's point, might will But offer combinations regulatory for supportive of settings. about are like allow guidance components being deeper that this at look a most can we would we're no But particularly regulators, novel discussion we

Operator

with Tenthoff Sandler. question the of Piper Ted comes Next from line

Edward Tenthoff

anticipate the there? the you It's do Thanks know of Novartis to guys in nice but how this been vepdeg, on. and XXX, most lot there's just what's from update. prostate advancing I with I the for have latest that and they And to cancer? you hosting know hear a going ask and conference. get questions on

John Houston

that's XXX all Thanks, last in year, And doing running know, we over the and did this the game we handing earlier the go to that the you of cancer. us several terms question. spent Yes, process of information as get of out-licensing months Novartis' materials, needed the data prostate have. in commitment plan Ted. they to to was the Clearly, still for that Novartis ARV-XXX. excitement that up is Great into and early out-licensing progress

track material of to Novartis are able and does. XXX updates with ARV-XXX. us on actually And scenarios we share looking XXX. the they'll progresses. that. be forward information it we come course, the on significant to interactions the as late-stage prostate plan of now in the cancer we're went kind be it well of based as pleased Novartis transfer how So from early for they're from has at game for but shared had, of the updates getting with being it really will think we've themselves, all future will and And we looking using on Novartis And out-licensed, with that Obviously,

Operator

America. Next question comes Ahmad Bank Tazeen the of from line of with

Tazeen Ahmad

topics segmentation Maybe the going the are ARV-XXX. that population use that Can PD about LRRKX? examining switch elevated to how the this of to you're specifically to of you determine the size population? you talk biomarker And have to

John Houston

Tazeen. Thanks, question. Great

Officer, We have with hand Angela the and room about her those for Chief answers talk to the us, in I'll our Cacace, questions. over Scientific here directly to

Angela Cacace

question. great a It's

Parkinson's to of that's of idiopathic estimated of X/X disease the pretty population, sizable. the is believed population about the size So have elevation LRRKX

And described investigation so J. it is still recently Conference. Foundation we've the how actually active you that Michael the would at under employ biomarkers Fox Therapeutics

with And group. so we're partnering that

initiative can LRRKX inflammatory markers stratify trial. as do Marker appropriately a as encouraged we reasonable Initiative stratify well clinical study understand to really that that data as we the really you have Progression So But markers lysosomal both their to well patients. both to conduct patients we're by that as suggests the the Parkinson's how

Noah Berkowitz

at and comers, Parkinson's healthy next in who move LRRKX. volunteers. is elevated are Yes. study the I We're and ascending study, that the ARV-XXX. ascending have are healthy Angela disease. single said, to of build take going portion the study. home dose They portion. -- And currently what running in completed And the just all reminding in look dose you but on necessarily we the that looking multiple with patients these volunteer don't might currently have this a We message we're We're

we we There's we data think how of point, to I heard degradation there's up patients wide-open patients all and interpret those of expect look all looking doing up these on depend And what It to from not selective learn of at have selection at will at going Angela patients various will of at our elevations. X/X a looking choosing at start to You that downstream with at approach. it. that generate the from being could going we end can we're doses that field. and this -- study. LRRKX the biomarkers, overall or elevations. But no at our end We the be from of drug

Operator

Schmidt from of Guggenheim. comes the Michael with question line Next

Michael Schmidt

and healthy outcomes Phase how a improving And had longer in just are year? interpret next markers you're ARV-XXX term? for study. Are follow-up X How those the investors volunteers predictive I perhaps potentially data that degradation Phase on the should PD X specific there than assessing? other LRRKX

Noah Berkowitz

Right.

study dose central expression this that's have what can what opposed this patients monitoring PK/PD when that if did about, system That's sets and volunteers. But activity that associated will recapitulated modeling that move success is modeling so of can the quite cynos promising for of we are the that elevated LRRKX the with that is importantly, the CNS of helped that the the and healthy in the in think think the the drug be neurodegeneration in confident on-target downstream track that more move can successful, that So its with dose predict at to volunteer doing looking selection is we'll drug designed healthy are more that's dosing right understand nervous that we there. portion drug to confidently, in things we're expect PD. right disease. obviously, -- we volunteers out really as the biomarkers We when and walk the this to at drive I then don't up patients lot that right when looking seen and compartment, human we is CSF. us that And a for the in be move the the relationship impact peripherally to beings, something I we and to with did we're in healthy the the of or this

Operator

comes Tyler with of Cowen. Buren TD the Van line Next from question

Tyler Van Buren

your Thanks want hosting just response earlier the follow-up the readout. VERITAC-X an call. trial to on to for for question I

X in ESRX a median X for improve analysis? population for arm or expect and on delta comment months PFS per control the how ITT arms population if X-month both months a fulvestrant near to your or to few the median the PFS do you plus does better a So you doubling, earlier see hope to

John Houston

Tyler. do want Thanks, Noah, that? you take to

Noah Berkowitz

earlier comments, to I Well, I'm said think want I I but part that, just Sure. -- said not going of what -- we sure to back the all it. of

the expectation in a is Our on the months X better months or fulvestrant arms. X treatment arm, few

what total ESRX do the that We the proliferation for will tumors. because this -- would expect the going estrogen patients little see or a have mutant on receptor-driven for estrogen mutant better population. haven't they ESRX differentiated ligand-independent receptor-driven we're their We to dependency binding for

few to specifics just plan. haven't not those through we it But into the -- or operating the a better, statistical outlined. I as gotten So we're of characteristics say, gone suffice months

Operator

ISI. of Next the from comes question line Miller Jonathan with Evercore

Jonathan Miller

first-line, getting that I'd combo abema vepdeg year. not talking the talking contrast like like portion at out. ribo or about? new on that Can next pursuing and you're Phase the least more It called talk X And in about you're it you Phase these Phase CDKX. suggests VERITAC-X to you're combos wasn't focused PR Xs it palbo like seems seems you're about with started Xs

you could waiting you're Is make X. you A? Because B, this decide from on the it can how to for about use combo you data TACTIVE-K decisions for talk given about -- update. you still the that would I available given little on noticed key partner, Phase details you on give data fair combination a -- internally mentioned year what data the combo from CDKX haven't course? some that Phase X don't we the a when guidance those when about to see And CDKX/vepdeg be deciding expect the you bit trials ultimate TACTIVE in combo So will

John Houston

different And think to a our influence Yes, there's of going clearly, decision-making. question. ongoing I to great going number that we have that's trials are really data Thanks. generate Yes.

We have VERITAC-X.

abema have We combo.

the have atirmo We combo.

have We SLI. the palbo

have ongoing also ribo combo the We as well.

for of data go bunch our able whole any early into to of year is colleagues, into decision. coming part and next down sitting right actually out of But a that's decide through Obviously, combination. do we'll there, the what more data So there's we'll that preferences with to that Pfizer, be now with the wait the Noah, but specifics? to want the you drive then

Noah Berkowitz

could in and Maybe the so then we and at a Jonathan. look second-line. -- we're question, look for Yes. we so -- first-line can at The let's little dive thanks more,

choice. in Pfizer that to first-line, our challenged to partner, risk in ago into benefit the CDKX/X they think most that So perspective in with was years is first-line, because I unfortunately, to prescribed setting. was obvious the that dose were able of some the the original and roll an it. Palbo could would and go lower intent so vepdeg/palbo we And that was that weren't a we health authorities. satisfy straight palbo find supply of drug from

differentiating very of will is And the out, portion the the atirmo. now also a we And be CDKX setting, fullness John have with the drug best-in-class but very combined we're it so in -- which this in done we to combination started the data excited is best-in-class for would it perfectly And well. as or VERITAC-X, which PROTAC a be that SERD into as CDKX/X superior believe alternatives. meantime, set, this we what would reading the of work would combination, possibly fit about the we have in would have atirmo SLI mentioned. first-line be But an because partnership

We're up some is or waiting or to a like don't in Breast think doing this to what we're vepdeg like, you for may make these this should things Atirmo of to end and palbo abema that I really and use. look like maybe considering to plus your specifically weren't abema/vepdeg of data for we But San us So great study, very ribo and by and another in abema. -- palbo that not all CDKX/X, which the be evaluation already we it, combination forward that guiding the we prescribers is opportunities is Antonio gives drug. we've right? that setting, but because second the something in to setting presumably could choice have results guided was those this. case offering solve combinable Cancer to the using because investigators differentiation combination that The a we of either viability about that problems, course, shared idea just of allowing this -- setting. we've ease of really the and second-line In they

more more that at While the with did about the see original broad we dose was there be drug. palbo combinability -- and data of data this we will vepdeg, neutropenia in sharing the full performed, for set now we the --

You'll abema data set. the see

understanding next metabolism for the year, TACTIVE-U better then in as ribociclib about work combination some the data the TACTIVE. atirmociclib as And of portion with updates of seen well as as provide mature said, some see You'll we'll the we've midazolam study.

Operator

Paul question with comes line from of Choi Goldman Next the Sachs.

Unknown Analyst

ramp in we modeling This is [ guess, Congratulations additional think after? about you from for the first just guess as think payments? in lot that like agreement, or you like million $XXX forward? how Or year about of how maybe quick filings, real we Khalid there's one, how is, Paul. cadence -- ] the Novartis quick correct going these revenue clinic we question have year, a you a -- earlier-stage on then for that call. calling should should I the are is, of that about is recognition I quarter, the thinking us And next do the assets on entering the had this the given cost in earnings IND

John Houston

question, questions. CFO, Yes. over these to to Andrew, Thanks and I'll hand for our answer your

Andrew Saik

expenses Yes. previously, Xs. going structure, our on have, was the to manage Obviously, Phase the haven't Novartis. is That given and out-licensed X the had Thanks So planning expense done doing manage that specific we by for in we on out one we're burn. our the question. company projects right? consciously and to company the the changing, mix the of Yes, programs near-term. We've look, that guidance not

to We're in given the through we're that clearly, going very with XXXX terms be costing sheet. into of little in the a cash start them, of our As bit have guidance going programs what and of clinic, confident to we've on they're other we we're current these coming balance well aware spending money.

question Can another Novartis. had I think if you not heard sure you I I'm on just that. that? repeat

Unknown Analyst

Yes, of course.

upfront million reported and just that you in from that So million agreement. that today already then like given has occurred the assume payment or so revenue $XX we $XXX

that Our just on we think those in total that I we color understanding there's like don't milestones. about you any the certain that wondering were billion-ish a contingent Obviously, on are payments XXXX? in but been could should how from is about have agreement think $X if of disclosed, of share cadence revenue

Andrew Saik

Yes.

our P&L right So the now seeing upfront. revenue on all you're the that is revenue deferred from

that period et the do the So year milestones, which trials, responsibilities upfront the that's doesn't from were the for still during and cetera. amortized much with this longer. handing anything to so it's Pfizer, With future Novartis over We because we have agreement have we over responsibilities.

deal that's XX-XX. from the large a had them, that's obviously we a a that's -- and upfront So

engaged we're that. So in actively

of time. over those period we're So longer a amortizing revenues

for So the see you'll off Pfizer on will Novartis continue some actually year. The years. drop this

Operator

from of Citigroup. Yigal with Nochomovitz Next the comes line question

Yigal Nochomovitz

just wanted components. comments of on contribution strategy the front-line follow-up on regarding I the Noah of the some questions was to and making

to would could vepdeg. the And support be that work, turns able you've have to Or data a versus with do arm. you that curious given including to atirmo of atirmo/fulvestrant to how I'm then atirmo comment. if and fact it plus you as with it's not I'm complicated today and more palbo/vepdeg potentially are So won't components, consideration an arm also you just that be trial a generated DDI if as where well out vepdeg, sure you if Pfizer a and the is palbo/fulvestrant? contribution you going it going pick pick of atirmo/vepdeg

John Houston

Great, questions. Noah? Yigal. Thanks, great

Noah Berkowitz

and try tackle this. I'll Okay.

Let's jump that. of in with part a missed follow-up I if

think you of so an in to all, be combination not would be that study, confident we guiding fulvestrant. design in we're first can on -- going AI exact setting the think of rather we're I but the than that first-line, focusing So more to I be

physicians, choice things it's that's not resolved these the with CDKX/X palbo haven't of part regulatory authorities on are been thing. alone yet. or defined, the So initial Whether

but -- there of what you terms In Is something asked. addresses of I think else? that kind

John Houston

related That's the design to part.

compound secondary related with Yigal, a San question come going believe space, any is tracking of a any non-issue Yigal think that I Clearly, have clinical mean is have I studies, the DDI kind that the had of onward atirmociclib. will about would to and now. will this I say, of a we Cancer start Symposium the show as which be is And very we see do say out our all this combinable perspective. atirmociclib. include cancer and idea that show data vepdegestrant we that breast what that a we're is Antonio from in you'll medications a the Breast what to that data, from I with would the broadly to in

Operator

] Jahangiri Securities. Next the with from Truist of question comes [ line Billal

Unknown Analyst

is This Kripa some were or [ ]. as on Is of of is maybe involved Bill well? ] factor take going what's to to deciding be final wondering that thinking for sort factors combo We factor IP strategic efficacy? the which it on [ choosing too Or there on forward? you're strictly

John Houston

to be be going obviously, we're it's Well, and generating data on are generating. going to that based all the

trials efficacy that that will of or tolerability. I we're with earlier, ongoing data palbociclib, the decision-making. SLI aspect be all type have As data-driven safety just next will all in abemaciclib, at end a ribociclib, atirmociclib, of of with -- tail data It of looking drive won't this at that year, we first year. really of and be the with And half looking in hands the combination our mentioned

So we'll set. of true our ] overall digital a view get [ data

the make think to smart be good in really decision I a position an combinations. we'll So incredibly actually about

have influenced the but said, be we set. I biases, will clearly, completely by there's some As the biases data

Noah Berkowitz

wouldn't would I is when first-line, that John, disposal data we the ORR is characterized point, in And PFSs efficacy wait things We would -- think that would for going see then and exceed second-line X comes to safety In median just years, at setting. to in CBR. probably one when the the add small efficacy probably obviously, And about points. our there what efficacy, are make sharing and data for I you like have a look, signals that. those efficacy other a not we're at decision. Yes. use where median wait We're by it looking type be first-line, Obviously, can of that to PFS.

Unknown Analyst

Great. And is there anyâ€¦

Operator

Oppenheimer. Matt of with question comes Biegler line from the Next

Matthew Biegler

a and It's the cap can the wanted like are it between a Is the at the to secondly, Thanks of an And testing? plan you endpoints a to label? ITT for hazard statistical alpha us. good top covering hour. between squeezing with tell Or just X.X here. hierarchical ask for co-primary analysts you do we're I ESRX extent like enough effectively all-comers I think me split ratio of the for be VERITAC-X large and the realize would the population? them, about number the

Noah Berkowitz

Okay.

The nature them. ITT, on the and than have for defined So the which more thanks just hierarchical hierarchy, purposes, the terms X specifics some that's likely Matt. mutant there, the -- haven't can of on of we -- We're win that the in. going for going we is we're think obviously co-primary disease be is the testing the to one in of all treating endpoints, question, we goes but from either ESRX There of that even to we yet.

second the was what part -- me? of terms your of remind In question,

Matthew Biegler

do what The hazard ratio, that you is? think

Noah Berkowitz

the About hazard Yes. ratio.

So population. but hazard into. ITT in And gone will of the haven't I a than are the ratio. to won't or ratio that the expect ratio better in to achieve expecting -- the hazard better hazard we I than more would a go mutant specific say specifics ESRX we that,

Operator

Next question comes from the line of Michael Schmidt with Guggenheim.

Michael Schmidt

had regarding just your follow-up. clarification question the on taking comments for VERITAC-X. I Thanks a earlier

major you to arm. what in enrollment months the there are -- wondering X relative trial said PFS to expect better you the I yes, or differences obviously in was much think for are fulvestrant control I that? And did criteria about fulvestrant just post-MONARCH X than any where

Noah Berkowitz

PFS which to twice. patients were ASCO. that patient better a an improved are it, with AI. in have median are an that at the with Yes. exemestane, there presented to both better. those why There was have the Well, final initial the think an had They treated same between hard-pressed say, and the at the the months in the fulvestrant analyses, CDKX/X the therapy may have population differences analysis, a let's change and X like an than understand was much endocrine we time X People analysis. X.X I didn't in interim do ability after were treatment months the But and little

patients all second-line will that not will have we So the Does study. will be, second-line, third-line majority they are technically, a think I pure were some patients be thatâ€¦ large but our and

Michael Schmidt

I really appreciate Yes, Yes, it a makes clarification. lot of that sense.

Operator

question comes the line Jonathan Next with of Evercore Miller from ISI.

Jonathan Miller

here. so remarks. my and that to GXXD be than [ love during KRAS Thanks follow-up compare better about much like will you approaches? And you discussed suited about How molecular of you're think asked has inhibitors? squeezing your a to the other figured that these in it, Can like pan-KRAS PROTAC I'd you the glue ] a other programs how I nobody Med. one ask to degrader Rev. going programs or degrader the do some is approach? since a GXXD approaches, pan-KRAS upcoming working the the on, prepared compare question pan-KRAS notably to

John Houston

Noah in terms our and posing what in looks terms question the like the great -- Yes, And the thanks. to pan-KRAS competition. very the it we're yes, of and of excited Angela you're about and can question, GXXD discuss KRAS and the and profile answers programs,

Angela Cacace

both nonclinical actively been both actively described and inhibitors our we've some out comparing and are the range that and of have there. our been degraders that superiority, GXXD GXXD to lead models known also But the we've have our been inhibitors data. -- to Pan-PROTAC those We've PROTAC a Sure. examine of comparing disclosed our shown in degrader

encouraged And clinical to pursue these we're profile, favorable in so really studies. molecules we're nonclinical looking with to very and respect very generally, our

So to over further I'm Noah hand to going for commentary. it

Noah Berkowitz

Angela. Thanks,

there yet. comparative can just for guess That's think we're that But suggests from I I haven't next But still about competition look, I is we seen we've forward-looking and entered So the part. something the what year. the address clinic excited opportunity.

look first-in-class, for other demonstrate a space. through us those in this needed which for but think opportunities go there for we So degrader won't liver for doses. types and revolution, the agents, see there GXXD are us first some when and the address I and is could differentiate, we look at Astellas' at to of And that now. These are at modest I be up, toxicities catch data ORR would you specifics KRAS higher probably but example, little right we premature

Operator

call Houston. our the And session. will over back this question-and-answer concludes to turn John I

John Houston

Thank data But from call. of for ever the be clinical you, first it. for hopefully, the and to you give thanks, you getting various we'll very over our your everybody, updates calling sets thank morning. this into time And months be coming the rich earnings that trials. Appreciate we'll able

Operator

conference This call. today's concludes

now disconnect. may You

Arvinas (ARVN) 30 Oct 242024 Q3 Earnings call transcript