EXEL - Earnings call transcript Q4 2024

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis Fourth Quarter and Fiscal Year 2024 Financial Results Conference Call. My name is [ Cherie ], and I'll be your operator for today. [Operator Instructions] As a reminder, this call is being recorded for replay purposes.

I would now like to turn the call over to your host for today, Ms. President Affairs Vice Investor Executive Hubbard, of and Public Relations. Susan proceed. Please

Susan Hubbard

Thank us and thank Year for Cherie you ], Exelixis Conference you, Results Quarter XXXX [ Fourth all Financial Fiscal and Call. the for joining

Aftab, Haley, me year and Senner, CEO; X, XXXX will our ended our President fourth the P.J. who Chris progress our Officer; January Mike Chief for will Executive our Dana Vice portion our Medical Amy Financial on also quarter Joining our are review and of Morrissey, participate Chief call. Q&A and and Scientific XXXX. fiscal President Officer; Chief the Commercial; Peterson, the of today are the Officer and call in

accepted which call today's will measures During today, non-GAAP accounting from our reasons posted measures is tables refer Please results. we well not such using these refer our our measures explanation press of financial as an to as website to for for release, the to principles. on generally calculated GAAP according deriving

During the and the events performance regulatory, discovery, financial will development, future be and matters. statements the of regarding of we forward-looking product statements making This possible developments future includes commercial, about regarding this strategic company. course presentation,

conducting important from development, you dependence differ associated could, level partners and compliance applicable and cost and the with that differ in to approval competition, to of verbally activities. identify review Actual product by time development events trials, writing or could related of results documents discovery, results commercial materially. with uncertainties to We cause processes, market risks expressed actual our materially regulatory and on commercialization product we time limitation, requirements, without success, business the and factors course, heading regulatory the collaboration today, SEC, including, Factors", the "Risk refer with the clinical our to from file those company which under

to I the call that, turn will over with Mike. And

Michael Morrissey

us a XXXX and updates components year on for Susan, we and into had important where thanks of the call January, to XXXX, you, Exelixis joining business. after a breakout busy everyone all today. our sprinting in Thank right. across provided All already we're

Exelixis revenue growth a pipeline and meet franchise business, revenue billion cabozantinib-zanzalintinib continued see competition, to in to establish our our to oncology zanza goals XXXX We're both of globally, the significant has for compared multi-compound, advance for we early upside priorities of with growth to as and aspirational and to in cabo built new in additional we cabo and $X and billion momentum thrilled indications. XXXX. $X absolute the see the and momentum in potential terms U.S. relative of expect multi-franchise

just news the the and at the and RCC at to approximate frontline and first, on but second-line highlights, our reiterate leading JPMorgan jump including: full quarter update everything revenue. with in focus monotherapy growth CABOMETYX won't here its outlined the and in priorities business in We in demand, TKI today, Healthcare cabozantinib strong top fourth TKI IO starts XX% new corporate as the January saw we start for the the maintained both a I of Conference. status important segment. XXXX performance year market XXXX

million were as approximately its and TKI, $XXX compared its franchise the grew compared to respectively. cabo role and by partners XXXX. in global franchise product U.S. year year Continuing billion the fourth grew year-over-year cabo XXXX, billion and $X.X generated revenues quarter U.S. product XXXX, product -- XXXX. We leading X.X net full Exelixis worldwide franchise XX% to quarter to $X.XX million quarter cabo net XXXX. Fourth year full revenues $XXX fourth Full net to revenues

will his business prepared remarks. in base for the review XXXX our Chris financial guidance

at a provide including will guidance, NET opportunity updated date approval. the We later post

to the Phase is for III priority with top trial. pivotal the the on NET Second, CABINET regulatory cabo indication sNDA our ongoing based activities advance

our and date presented were for final had of recall, supported England XXXX. updated FDA that concurrently published to April sNDA seeking the Details cabo CABINET addition Journal at with approval a PDUFA of As cabozantinib were from ESMO in New the NET. results announced XXXX for the or which the recently X, in we guidelines -- you'll NCCN accepted of epNET Medicine, both indications pNET

process the closely and to collaborating on won't FDA the that any details review with speak today. We're of

conferences to As as launch and we've are and ready investor soon engage webcasts, we approval secured. highlighted at eager as recent is

next cell include take top and III zanza oncology our of stage franchise in of from nonclear advance occur cancer to each line STELLAR-XXX and event center XXXX decision milestones projected in cancer, STELLAR-XXX half portion rates the anticipated Head-and-neck in kidney we from cancer as second to colorectal the Important pending data for a all STELLAR-XXX results Third, to Phase year, opportunity. trial. the to zanza in expect trials pivotal in

to expect the initiate STELLAR-XXX RCC we XXXX addition, belzutifan half evaluating the Merck in of studies plus In zanza year. NET this trial zanza anticipate will in of first two initiate and

third pembrol again I'll of Recent for ASCO contemporary and during GI cabo are to is success against focus combination believe development running Exelixis pivotal zanza standard trials of distraction comparing any Highlighted for for trial. sunitinib indications, which call, our XXXX quarter care STELLAR-XXX. STELLAR-XXX and overlap each based activities. billion in the zanza on the for our zanza that on remind independent from misguided $X we STELLAR-XXX, placebo from Regorafenib speculation is cabo. a for and our with is a projection zanza everybody

to several recently, Exelixis to with for looking XXXX, based extensive years IND we differentiated Phase molecules the on we're next as preclinical testing. is pipeline In the our potentially PARP accelerate full as Fourth, highlighted XLXXX deepen for that with as PARP as combination I development prolonged refractory of to inhibitor a therapy therapy, tumors well responses. have in inhibitors become and potential

for new for to XBXXX XBXXX, and trials Phase progress XBXXX. we're and XLXXX I and to up opportunity of the XBXXX Also, INDs pleased THREE see our file with

number a scientific expect We these for significant molecules presentations XXXX. major throughout at data of meetings

GU/GI in Back-end future transactions our franchise focus the priority. Business tuck late-stage activities oncology potential pay-for-success on top into space. development and remain nicely existing a continue assets loaded to that

terms expected of and to repurchase to we're free confident cash sheet have allocation, priorities, and continue assets we capital our the new flows balance conviction the pipeline advance In access high shares.

extensive release year milestones that, with press key full see So achieved of and our quarter corporate in list please and the for our financial ago an fourth issued an XXXX results quarter. hour

turn the now to I'll Chris. call over

Christopher Senner

Thanks, Mike.

clinical of net revenues in million company sales revenues the lower quarter million. For sales, the QX of included product million, net $XXX trial $XXX.X product $XXX.X included CABOMETYX clinical trial approximately XXXX, revenues total than XXXX. $X in reported and which were approximately is cabozantinib fourth franchise which our million

franchise we and gross-to-net increase D in As in is Gross-to-net the trial into a cabozantinib for continue clinical the deductions Medicare quarter of to XX.X%, XXXX. the quarter historically gross-to-net the commercial XXXX the continued for higher higher XXXX quarter have been experienced sales choppy reminder, this incrementally expenses. was in Part which This primarily future. our expect patients fourth the fourth co-pay quarters, between we in and to is than assistance related

XX% Additionally, XX%. be we year XXXX estimate between the will that our and for full gross-to-net

a As D included gross-to-net all in the sales Medicare to designated manufacturer, X% our Exelixis XXXX discount year. has estimate in Part been disclosed, as small and is specified which previously on pay for requires Exelixis

primarily to mentioned gross-to-net As in due higher to past, we will quarter gross-to-net that we similar, expenses the in of have quarter our higher the and be the tends XXXX patients. project be year, first first assistance for co-pay the commercial

was inventory third XXXX. at compared X.X flat trade at of the on hand year quarter the end CABOMETYX Our to weeks when the

million includes royalties Ipsen revenues, earned sales million and from our in on of revenues $XX cabozantinib. Total approximately in included approximately also Takeda $XX.X their collaboration which partners

for XXXX, total the impairment operating third The approximately XXXX. $XXX was higher million and and expenses restructuring for costs sequential trial to driven licensing clinical in the administrative expenses, in and compared by quarter million the manufacturing higher development operating and candidates, charges in costs drug XXXX. quarter $XXX fourth these were quarter costs, primarily by Our excluding increase fourth general higher

compared fourth taxes $XX.X XXXX. income quarter of third Provision million the for taxes of million quarter for provision XXXX $XX a for for approximately the to income of was approximately

reported quarter and million of fourth company per million approximately $X.XX non-GAAP income also approximately XXXX. of share the or $XXX.X or basic net and diluted. $XXX.X net for The The reported per of GAAP basic share per $X.XX share company diluted per $X.XX income $X.XX

the excludes of million stock-based net of income impact of Non-GAAP effect. related income compensation tax $XX the approximately net expense,

securities marketable XX, and $X.XX was ended billion. XXXX, December year approximately the Cash for

an at the retirement XXXX, we average company's repurchased of shares, the share the approximately year per $XX.X $XXX company's fiscal million million approximately shares of of in During price $XX.XX. of resulting

authorized approximately year in end As $XXX the the million million remaining repurchase had of fiscal under the plan company's August $XXX by XXXX. of Board we XXXX, stock

finally, financial for financial Slide on guidance We of to XXXX. earnings during announced And our presentation. year conference turning is XXXX the detailed our January, the full XX in which JPMorgan guidance our

provide guidance, including later date, approval. we mentioned, As NET post net the updated Mike will product opportunity a revenue at

the turn call Mike. to over that, with And back I'll

Michael Morrissey

I'll their for Chris. efforts entire All outstanding up thanking right. wrap XXXX. by team Exelixis here Thanks, in the

urgency Exelixis past this success discovery, and and to our previously, for as challenges and continue advance said I development, I've in navigated at and our straight line everyone comes individual business, a in want As collective commercial we never resilience commend priorities. their and to

in our support to recover the your on be on for of the that updating hope the excel longer. interest to call we're questions. as the forward in mission and the for XXXX and so in now be the patients hour we and up stronger Exelixis, future. makes serve to every for you inflection look to part future. another patients to is continued proud now and I We am shaping Thank happy our count cancer live we year and to progress open help you already business, team

Operator

Instructions] [Operator question Truist. the of our line And with Goonewardene come first from Asthika will

Asthika Goonewardene

progress misguided just important like to something lack earlier think that. seen you the not And just little little one you about, Congrats is to would product? be? overlap today, where just about zanza force you've the get the in but generic is, more, dismiss payers, I approved who's bit about made one, cabo indications looking can will thoughts on the notion think you see that ever don't happen, of your and like the talk actual zanza here with to going I a could that I us generic substitution bit the for I I'm if that Mike, you everyone here. -- a guess, talked worried anticipate of for a to on the just the all cabo, that

Michael Morrissey

don't Yes. Thanks, I on that want level details. Look, speculate Ashtika. to of

standards individual with STELLAR-XXX. to care combinations well zanza comparing to have plan are area. for certainly we as do is STELLAR-XXX, of STELLAR-XXX the that NET XXX focus main planned the for as we think I We in what

goal here that to it's to, trials So global, there. allow randomized pivotal if forward. push those us obviously, positive run large, indications data, is to the be able generate To will

focused into executing therapies. efforts us. that's that challenging. really certainly Everybody knows commercial II hand-waving the patients the moving out ultimately, the helping need data or comparison forward, single those So reading sets we're randomized that's who zanza only small and in comes what data will to trials -- sets, small and that. and we get is patients these We a drive that, to that on Phase pivotal as because All arm, setting, running, need and know better more very label-enabling the very between very,

Operator

next moment for from will that with Michael line question, the Securities. Guggenheim One our Schmidt come and of

Michael Schmidt

of are the NET, the you of for One for given pending expectations this formalization, any potential bolus is here and initial currently Do that disease? about for a launch sort is sort how discussions uptake? label thinking see cabo on an trajectory and you indolent

maintain thoughts beyond then zanza, Now the the are especially comment can to emerging with you safety On your for more on that data when intensity dose combining ability inhibitors? just on and checkpoint we current have profile? with zanza, RCC. And indications what balance,

Michael Morrissey

part? first the take to want you P.J.,

P. Haley

Yes. the Paul. question, Thanks for

NET, team that that the previously, significant. XXXX, said, fact And talked I the say, help believe pending is, Mike go to ready, are so with neuroendocrine at we the excited That market. opportunity the with the can XXXX billion. very to oral contemporary about as launch market, that ready patients we FDA and appropriate So approval. in tumors mentioned, in have to an as market said is regards the look believe completely we and would and NET within we the shares we just opportunity we've pricing is dollars about We $X oral

So, substantial opportunity.

NET kind SSTR And all really broad only set, its when data of CABINET origin for the that we think study cetera. sites and the set, et of addresses grades status, of all about a the the different the data different it's tumor, --

a So patient it any can pending really approval. type choice NET be of for

the We've customers written that both talked currently customers that of XX%. as about of already on-label calling prescribers about CABOMETYX before, we on terms for as our overlap too, is approved have we in see indications, who are well

that's So significant.

that and with. out, really that when efficacy It safety. makes to they the really see. the hear come terms dose out speaks profile. this. they're And gates in ability reduction like us the the excited fast toxicity familiar are from the is they that find And for comfortable they that physicians about and They launch to them understand really managing market of of accelerate So research the this we data, trajectory cabo of

just out this there patients. really to to bring wait and we're So get excited and can't

The that here, final effectively generic. Everolimus Captem too, oral therapies competing I'd the mention thing are is with sunitinib, and we're all

of So this give also of us, we other voice aspects advantage things. in a share terms substantial believe, of and will

launch. for excited the we're So

Operator

moment from Morgan Laaman, that and Sean for the of One Stanley. line next question, comes our

Sean Laaman

there. My bought you cash worth sheet. Despite the stock. to $XXX question statement, back of There's I million on liquidity think the relates balance good really flow that,

of of talked OpEx. our in development I sheet. kind balance three winding up about to it I a XXX, going correct with you've you're highly think has investment up accelerated looking terms Mike. liquid discussions neutral you're still zanza, net the in but been suggests think probably said, that of commentary in new But still you down winding I potential it outcome, you're got and at if a INDs lazy cabo, Then past end that

think the of about So you bolstering buybacks in versus pipeline terms further M&A? how with do how would -- potentially that

Michael Morrissey

question. Yes. Thanks for the

other So to I'm If lazy. so, not sure want most characterize flow is much that. then to aspire that I'd free cash would companies

they and of I So with the look, priorities we of the run so a yes, have think cabo, we capital our with articulated where our move rest help appropriate have shares and to when think is appropriate, in going the when we to the business forward zanza, for patients a can can pipeline. the -- goals move then assets conviction with price plan buyback we pipeline invest the a with that allocation we've new for business revenue great will needle degree forward. built discipline and a We

responsibility carefully, forward way So would term. the in the in have that pipeline, different term three cash and manage we opportunity, the of short then returning I business in terms long that shareholders of very to those argue BD a in and the tacks to the terms moves

how based terms And data behind about the optionality put and and We're to we where year. tells stop in flexibility. like in like we'll $X about, the that think of I and what upon the prioritize and losers. us to winners have R&D to focus when that this opportunity money in the So I that spend spending we billion comes

to handled, think looking I move we're a way helps ball for the shareholders. we've patients to and So and got field continue build well down our that value that the forward in

Operator

for line moment will Lebowitz the Citi. that come David with next One from of our and question,

David Lebowitz

could like? clinical how what the to GI, tell label relative and might should look you presented the we various drug in view subgroups ASCO On recent the might net used how data practice the in us ultimately be about actually

Amy Peterson

for Thanks question. this the David, is Amy.

agency. it We're reflects to really with So evaluated and like. what patient negotiations a broad the that label in the population. CABINET, was might given But we in population very discussions speak the can't really look

pancreatic We origin, whose neuroendocrine consistent we're tumor from all neuroendocrine enrolled neuroendocrine the neuroendocrine ASCO with were benefits neuroendocrine shown expression tumors somatostatin functional/nonfunctional was GI lung benefits their originates levels, receptor benefit of tumor, population. the have overall and GI those patients tumor, tumor, seeing within the And GI what subgroups. a tumors regardless at benefit their across and

broadly So applicable. again, we broad population, think,

Operator

Akash One Jefferies. the will moment with and from come of that for line Tewari our next question,

Anastasia Parafestas

on I had This Anastasia NET. question Akash. is a on follow-up for just

much Specifically, versus NETs wondering sense versus might guidance, long-term give how for us the could that would a comes If near-term of XXXX that you of look be like, your just great. growth indications? from what other

Christopher Senner

Anastasia, it's Chris.

is, as at we -- label we our final haven't said post-approval. trajectory understand future we is some our do and but we So the in that said -- and launch JPMorgan, the in today, we've put when also NET what understand what guidance. haven't We'll at point

Operator

Capital of and Renza next moment that RBC Markets. come line will Gregory from question, our One with for the

Gregory Renza

relation Congrats to just getting prostate pulls in more on ask more and beyond of to NET, of just and the expansion, out for in, cabo, progress. comment on you pushes course, that the CONTACT-XX. submission a of a and that pursuit Mike, bit wanted cancer

If that you a absence and your and there? the of course, in plan in confidence timing OS your row getting could just speak ducks of regulatory an on to process,

Michael Morrissey

Greg. Thanks, Yes.

As about only, view PM, regulatory Once singular reviewed appropriate at you the approved. we NET the now of give or on the time, focus getting circle point year where get done, we And the is early will over CONTACT-XX. goal back line a that's to going. talked having we in opportunity with prostate our at that from updates right that

Operator

Fortea-Verdejo our that for come question, next moment One with the from Wells line and will Fargo. of Eva

Eva Fortea-Verdejo

for us. quick This Derek. from is one on Eva A

STELLAR-XXX was on but the wild-type and population both wild-type. the population just recent in mutant, patient the readout, RAS So STELLAR-XXX, patient included is RAS

the could about patient [indiscernible]. in overall population plus zanza for be we how should differences how impact survival the So thinking

Amy Peterson

Thanks is Amy. This for question. the

remind because type that's three of STELLAR-XXX, metric in observed zanzalintinib you say saw components that, whether purpose or And wild added of RAS atiza for was course, to wild-type components, everybody to contribution step to OS. establish what of was across zanza higher going there of just contribution efficacy contribution atezolizumab components. to patients. colorectal back not one was really patients in rationale patients I'm PFS evaluate those when with in all actually second a cancer. ORR, study, The of of which we -- choosing it the was a to that we or So to responses namely the Suffice and

we're encouraged those And so by results.

second XXX, to, in the to say As about half are we as results regard really as Mike that XXXX, saw anticipating the I the through we read to I the how of through. STELLAR-XXX, and that's think far all events, we're encouraged by to with alluded pull that can

Operator

One our that next come with for of moment America will the and Bank Jason Securities. question, from of Gerberry line

Jason Gerberry

to just about the $X the peak. follow wanted earlier up I Mike, comments and the on non-overlap billion

investors guess the against in can't I comment struggle the issue investors the that an won't you designs, to I added to is either which of with I understanding? help still that of that I RCC of you tell trial standards RCC imagine you when or patient nonoverlap. and lack RCC maybe agents get big but the the around we the of novel second that that, anything answer addressable And can kind the it Merck a guess, or is just of offer disclose compare cabo, percentage combination your you benefit, care. half And one think incremental thing really the much until I then that drives patients what build. suggests think the is about are

Michael Morrissey

just looking we about the the in three that XXX, abbreviated think trials for Merck right? we're is the more I'll XXX, at Yes. yet. to repeat And Look, way XXX. a and this XXX, that pivotal would I how I fashion talked to trials Thanks, running obviously, XXX, haven't at Ashtika, said look Jason. I just

information little come a the more being main of those is the bit into standard comparison focus The there's there. care trials. run in that's So to pivotal

and look We does XXXX think XXXX differently forward XXXX. will and look and to in RCC the just than in that space, RCC it XXXX in

to of and of nature actually to pivotal trials oncology planned be success competitive what then look frame looks like. look all and you'll to what's at happening the able to true have for that You that forward indication

you comparative safety. comparing some we'll is we against small of a cabo and with all early the three part single easy and studies. cabo we right we're certainly excited the next XXs, wave you standard of and teens how And going second going care, in The have we number we're about caveats zanza, have bottom arm, and looks the in do that. expect cases, randomized as compare efficacy compare you line forward. standard now. with We'll doing with wave the understand to zanza I as by the data pivotal more generate with having zanza good coming of of of So how really you trials running of did zanza going care, after small three And And that, that's and right late year. define the this where

Operator

come line One Andy of moment with question, will the our for William next and from that Shay Blair. ] [

Unknown Analyst

So corporate modality focus. core is the ADC a

it's I'm learnings about to specifically, they same do best-in-class? antibody component? share curious the leverage ensure just more the that to So XBXXX from And XBXXX the can you program

Michael Morrissey

Dana?

Dana Aftab

Thanks payload. of sure. same inhibitor drug Andy. with and antibody is Yes, a so antibody the microtubule payload. ratio XBXXX XBXXX topoisomerase a X a the for Yes, factor with targeting was This uses anti-tissue drug Dana. targeting ADC a question,

XXX, how binds very not about that move antibodies problems causing of biologic, remain because that opportunity we're with clotting. with the We're it differentiation that excited differentiates tissue factor. into about potential Most a antibody And cancer. excited factor ADC, colorectal how importantly, the gives other blood about us with it with excited from we potential to, an epitope to

with GI NETs. talked and on colorectal, with Mike's know, a cabo really franchise even times you how in many with past the focused and we're zanza STELLAR-XXX building about in As

us move a a bit franchise ADC. this with So create into of this opportunity another gives and that to indication

Operator

moment Yaron that line from come our for of question, and the next One Werber with will Cowen. TD

Yaron Werber

or Mike, take whoever wants Great. interrelated I an question, to have it.

now. future different than is I mean it the sounds RCC, to going look For like

want announcing -- of trial say the going we to that we don't line? Is assume too it ahead first going IO? a with should thinking there's to much I should design. of you're about But and triplet you maybe how be zanza-belzutifan So combo to know sort

then see just do III? II, progress then what Phase want go/no go to based STELLAR-XXX, what's for into you on Phase secondly, And the the to the

Michael Morrissey

Yes.

follow-up as, I the around guess pharmaceutical going I working standard RCC your is care frame think, biopharma I is would question community of improve everybody So forward. to

I think the how how system, into that's move goal right? new patients, that's help we actually and the we board. the across That's molecules

certainly, here So there's nothing with right? different about what zanza, is our strategy

We're with contemporaneous molecules using efficacy appropriate care to what we be be think to safety. is compare a to and improve of efficacy partners the combination best-in-class TKI able standards prove -- against to able

ahead, So Come to to then, a process. all But ahead, going why we're The the to on. That's the goal improve are be these you here. patients. same goal. the dropping for frank, looking X it's standard outcomes be we're That's right? if ball, assume years is

with into to or want the into about what's to RCC. the weeds don't happen roots I again, going get So

trials the we're We're doing appropriate in many cell RCC, and neck those after CRC, right announce improving with of for focused standard and now. more cancer. plan to But with again, head patients will time XXX that. The it care non-clear We XXX and at XXX on is with cancer come Merck.

tuned. stay So

Operator

that of and for next will the line from with Peter Barclays. moment Lawson question, come our One

Peter Lawson

just maybe very CONTACT-XX. you I around thanks much; question] details for {indiscernible] Thank the guess all my

it could year. it know didn't about of Just give today. at that on us update talked you an hear stands. I if the mentioned I the you where beginning

Michael Morrissey

Yes. Thanks, Peter.

singular that indication, secured, view I that ago, approved a and more that's now minutes then CONTACT-XX CABINET as the today. to focus that focus to on we'll a I our in CRPC, mentioned NET is Once think on few right on focus, getting point our from moving of back and add main forward. Greg, regulatory nothing

Operator

our One line will moment of Willey with Stifel. next that from come and Stephen for question, the

Stephen Willey

versus is wild end know on the of primary you question on a of follow believe, expected mutant the RAS in Maybe XXX. help the kind only. distribution just now first that the type what us expected trial? version, RAS/Mutational wild-type point of to in I understand efficacy specified to upsized just Can I in version status up this the be was

there mutants. think put RAS place enrollment I had that was an for you in cap

changes So on RAS[indiscernible]. upsizing if can whether wondering comment now expected the here just the you of distribution

Amy Peterson

All for Stephen. question, the Thanks right.

liver without of the understand for it the So, them. as liver patients you type end we Especially following, as example, those were well well. focus and and which patients than, Also been that data most non-liver the do to we situation have without seems others, RAS wild we or on point we doesn't have say, population. therapy in without stronger prognostic mean that the metastasis. that primary met rationale from [indiscernible] that to doesn't IO much work or patients of that mutation demonstrating mets, studied been patient to liver because for with just right, patients was the that referred patients in more with mets. The did is modify publications It's

the status but study, to you that wild So what And when it can't on the really the the breakdown comes, modified focus of versus answer. the I can't give is study to in mutational RAS now, I right ITT we you'll -- patient will met have population. really the be -- type the non-liver data

Michael Morrissey

When Yes. status ratio refer at the to Steve, and paper. in broke -- least LEAP-XX by they Merck both out you would by hazard RAS the I presentation back And mutational population, RAS study from plot, okay, mutants X.XX wild that wild-type And the for actually the did hazard forest ratio. X.X mutant the and was for the type. better than the population

us. that went when mets kind Phase certainly then as was from of think Ib on non-liver right mean a hypothesis a or combo the from So liver again, LEAP-XXX was out I to IST, cabo came -- where focused story I patients think XX XX people It But started if the generating. patients are interesting from evolve and way. the to I met

In globally global fact, the trial. take large, very Again, way, account. that for rest us that's to the other important run -- a was randomized mutants into went pivotal

standard our us gold about how the evolve STELLAR-XXX. point then really to So from of it's guiding view on

Operator

line One from Verma and question, moment our will UBS. that of with next come the for Ash

Ashwani Verma

So if for look would in trying to cabo, efficacy your zanza seen and the this allow peak of versus we've still data but to you broadly to more CRC compare I'm with speaking? it at with this sales what hand, GI zanza ASCO to Regorafenib, level plus get not you guidance atezo efficacy, the

Amy Peterson

Thanks, Ash, the for question.

a for XX.X actually all in actually regorafenib study might clearly the design for be demonstrate we're has is contribution data say, the did we saw. efficacy that you what by really there through of that or endpoints. components, anywhere median months How X.X we When against what that three zanza/atezo, across remains OS one or whether look the Again, demonstrate example, where ITT encouraged seen. X.X not So the was was the to the from at outcomes of with actually to literature expect published overall for survival months. bodes to in well to pulls been XXX which

a can sense p-value said, III study Mike we As truth. Phase generate some that it requires that as randomized gives of large said, has have a and very you

in data ranges given recourse non-liver from also, median And survivals as control non-liver the data I overall the II median arm overall Phase patient other the the And couple that the IO published met met and the median population, survival months. in think, from to the an patient well ranging and their that we thing RCAD to with XX.X mets from and includes XX studies months. know well, survival XX bodes XX.X Foundation [indiscernible] was out, about from XX rego as cas months in non-liver of combination the I'll a population, point correct in set

we're well. So benchmarking

Operator

and that question, of Sudan next will our line Loganathan come for with the Stephens. moment from One

Sudan Loganathan

XXX, looks the the I kind submit potential force does to to one it's -- and and XXX the want to programs prioritize all approval? submitting R&D that include approval you what does bring sheet the for good, balance regulatory three if of have or over stellar about simultaneously, the ask taking data indications for strategy that and undeniable guidance of the to Specifically, there XXX, program first, others be will driving can market the

Michael Morrissey

for forward here would great And the trials Yes. and We're running question. with and game trials view. only those a in moving speed take that's our If The of a the of then them regulatory obviously, Thanks is we focus. pivotal business. from Yes. work, the forward gauge point p-value.

with we've that doing done here, that if again times cabo certainly on successful. numerous plan and So

we're in but there's just So besides -- no the work. Clearly, execution having just phase, studies no gauges. gauge

Operator

moment [Operator our Sachs. of Chris next line that Goldman One the from for Shibutani with will come question, and Instructions]

Unknown Analyst

Chris. stage This pipeline. touch is I the earlier wanted Kevin just for on to on

year. be You there of a mentioned that number presentations this should

on then as ask to we in data of decisions these to go/no-go in, as new it are you wanted programs? updates. three amount that cadence And the of coming relates see how you making the might about Just INDs these think

Michael Morrissey

Dana?

Dana Aftab

Okay.

presentations So we're don't scientific is remarks, more that published. as prepared at planning the his said meetings. We information than in for Mike typically give abstract until

just stay programs. on would tuned I those So say

those we're So excited the programs. to the community to on data present about planning we're that

the -- to we The of start best as a follow -- practices follow toxicology. which pipeline, assets tested. is be the the investigators INDs early-stage for be file Phase and good trials. And that we as GLP activities, that the us in then We bars hypothesis what then all required convince the IND-enabling there are I is to well that a cadence the certain to I industry, pass of would including regarding consider

track So start executing are with on three of we as are by we'll the INDs those and we those announcements assets, accepted progressing and that trials. continue those FDA, to all make

Operator

time, this there questions. are further At you. Thank no

Hubbard. so turn will the Hubbard? call Ms. today's And Susan to host, I over

Susan Hubbard

Thank today. thank questions Thank you additional you. We may calls Cherie certainly for joining all and welcome us any with you follow-up have. your you, }, [

Operator

participating. program. you concludes for all today's Thank This

You disconnect. may now

Exelixis (EXEL) 11 Feb 252024 Q4 Earnings call transcript