EXEL - Earnings call transcript Q4 2020

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Operator

Good day, ladies and gentlemen, and welcome to the Exelixis’ Fourth Quarter and Full Year 2020 Financial Results Conference Call. My name is Latif, and I will be your operator for today.

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. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. proceed. Please

Susan Hubbard

and quarter for financial and call. Latif, the us results you fourth Exelixis’ full thank you, joining all for conference Thank year XXXX

me Officer Vice Schwab, our our Medical Officer; review Mike Senner, XXXX is Joining our Haley, and Chief following Commercial, Chief call commercial here our who P.J. and CEO; our progress together ended quarter December Executive development, fourth our Lamb, question XX, Gisela and financial, of Chris Morrissey, join Officer; corporate, Financial Chief our and will the today’s Scientific also and on the us Peter XXXX. President for President are will prepared for remarks. session answer

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

with commercialization product level dependence the with on the I activity. the conducting regulatory and product the development, and over will expressed forward-looking events performance market regulatory, verbally of requirements, discovery, business financial statements clinical processes, regulatory development, future will risks cost and success, statements partners the collaboration of regarding today, of those be making applicable product this and actual in Mike. from During our and This possible uncertainties developments future includes commercial, about regarding presentation, strategic course, to without differ company. we factors that with by company the could call Actual that, events or to Risk identify important and commercial We SEC, heading Factors, results results turn could, differ we trials, which, refer And cause development you the matters. review to file with to to materially competition, approval limitation, materially. the of documents including time and discovery, related time associated from under the course writing compliance

Mike Morrissey

in assumptions with and for to the at as our will cabozantinib combination to the you, joining hit Susan we ASCO busy both us XXXX This strong the beyond be in a and when a a for Exelixis as an runrate $X.X Thank share annualized U.S. Obviously, are first-line in on guidance. the on positive end fourth CheckMate momentum developments have recent for by and from based variety full revenue revenues of heading for significant prepared everyone issued into we RCC ended the pivotal our and cabo/nivo regulatory update us -XER thrilled running approval accomplishments. accelerate launch JPMorgan our milestones. year All and release results are a combination quarter RCC to recently financial list ground growth today. GU of modeling expect as a corporate in exit right. launch January the XXXX’s partner. key including today of billion thanks if single for updates keep with financial in with a first-line was XXXX near clinical hour strive XXXX the providing in cabo and extensive We with mission-critical quarter, a number of and fourth see anticipate cabo/nivo had correct. call press Conference doubling agent results the and that trial. We’ll Please we our at XXXX as an important the full the of short remarks we we week ago we Healthcare RCC ICI the believe

INDs, packed and important potential sNDA additional to as cabozantinib and of development we forward that as ahead third, three foresee It broad proud year milestones up to submissions, the are fleet our for we first, COSMIC the action over and clinical of discovery, course the incredibly second, for candidate of am I addition, regulatory In a advancing two milestones XXXX, the including of the will goes of of building XXXX maximize program, across and discovery working advancing evaluation fourth, fifth, deep us. XPXXX trials, entire the finally business displayed our Exelixis XXXX programs status. the times. range excited be challenging these team bench team XLXXX and during an commitment clinical XLXXX sixth, by clinical the of a focus stage exciting one in and CONTACT early without full success drive the future molecules saying chance toward of new development the and we

the turn will year our over Chris, full fourth I’ll XXXX results. financial quarter an that, with on and to provide who So call update

Chris Senner

Mike. Thanks,

of For the revenues included quarter revenues revenues million. fourth $XXX.X the reported Total company XXXX the Net of million. impacted quarter total fourth were quarter XXXX, net revenues positively of the inventory $XXX.X by product wholesaler Ipsen, franchise of cabozantinib Total $XX.X for from from in in Genentech. approximately weeks and in approximately and hand. included wholesaler increase to collaboration on increased hand Takeda weeks inventory. demand higher also revenues X.X by an CABOMETYX million on revenues product X.X

was expenses primarily licensing quarter income expense expenses fourth and quarter in million net a December reported of was expense, tax $X.X fully $X.XX of for $X.XX the company basis. of diluted fourth clinical excludes operating $XXX.X $XX.X million XXXX related net in GAAP in was from was Cash taxes basis million for or expenses, milestone Benefit investments quarter billion. the diluted for by expense approximately the fully were to to quarter and third $XXX,XXX, The XXXX development impact and the the of fourth declined approximately for $XXX.X effect. million The $XX and compared stock-based XXXX. million business with related ended compensation activities. the per of a third income operating net quarter of company of XXXX. decline over the primary or trial-related of of share XXXX income $X on $XX.X quarter to income Our Non-GAAP compensation the fees for million existing the stock-based the declines also million, which net per XXXX. compared R&D $XX.X driver income reported on new share and of associated XX, of non-GAAP

be of are the for to does And to be our expense activities. over finally, of of in million billion. in Guidance of conference $XXX the business to $XXX compensation year $XXX of to for Research between $XXX at Total approximately be projected financial to to which turning to and potential revenues general the revenues. $XX compensation The million range million stock-based includes net XXXX impact and non-cash Net $X.XX in are of we’re $X.X the and million Cost expenses investment of Morgan and $XXX XX% billion projecting the million. tax and cash X% $X.XX Now, range expenses XXXX, be goods development product between the and rate January. million of includes cash guidance expenses in XX%. and in to range X% range be sold Selling, of $XX stock-based and of related JP and full projected R&D range projected and we the are Gisela. any new product that, previewed turn expenses include projected billion. call revenues to guidance the not non-cash effective billion $X.XX is in and And with administrative I’ll projected the and investments are to be billion. to is million. related development approximately in of $X.X the

Gisela Schwab

XXXX Thank Starting highlight the are and our new a towards compounds XLXXX progress our great And is and GU have of and during start off regulatory for great XXXX months pleased to and a you, ASCO in and our topic Chris, am moving XXXX to a clinical last provide cabozantinib main we on few I update with on made CheckMate as brief development progress evaluation. -XER. preview of focus today. program, the

by parallel on of we Exelixis its filings FDA’s survival first-line under combination nivolumab, compared recently, plus RCC. approval nivolumab regulatory enables ahead of PDUFA or granted XX, for conditions date RTOR FDA XXth for was of set survival, for well BMS for response sunitinib that and and of approval program are advanced the The was with overall XXXX. rate. based review efficacy to we and of FDA and the three oncology cabozantinib cabozantinib delighted for Just superiority the approval progression-free that review submissions with FDA the on February reviewed real-time the the January treatment life-threatening all of demonstration patients endpoints, objective the announced expedite

of HRQOL results compared forward look included high XX despite compared Index included also to to life assessment or fact that important level combination the health-related nephrectomy, cabo/nivo of at Conference poor by RCC. of high the proportion to for quality as differentiation a combination study of associated with first-line GU, Detailed today but a the results of Symptom and the quality in primary well and results the first and compared well for higher analysis analysis HRQOL the of Symposium. more – detailed was with additional as ASCO mg and with to Cancer as tolerated results study first-line the of XX level the a life Presidential nivolumab QD FKSI-XX IO to XX rate. in nivolumab low other risk and intermediate for of think patients life the Virtual improved represented presentation population Therapy trials enrolled patient TKI of recent We discontinuation quality options. but the of showed and a we time presentation Kidney generally The up of at Additionally, other lower sunitinib. ESMO functional may provide these The as cabozantinib IMDC the a proportion up this or at for doublet cabozantinib

ongoing cabozantinib. the for program Turning Phase to X

enrollment We execution results have for XXX these that highlights have program. we’ve for a have on trials are either on and track completed XXX, and continued studies our the on or completed summary full as XXX, global XXX either or of key brief And nearing top-line level. previously for provided COSMIC a efficient shared

its resulting that in For in survival PFS of hazard significantly with X.XXXX. therapy, versus COSMIC and have progression with death a that iodine-refractory highly ratio or cabozantinib disease X.XX targeted progression-free risk of we XXX, of XX% highly was statistically met less a value a reduction XXXX December prior P radio trial patient placebo endpoint primary VEGFR significant than received the with of improving the in who announced DTC

and results top-line cabozantinib a working first-line HCC COSMIC study X NDA submission, the PFS goal trial with versus versus ipilimumab of we of patients expanded XXX, completed Phase expected in of population global of XXXX. in patient interim unmet our analysis analysis the and first-line RCC are and atezolizumab the patients comparing IMDC COSMIC advanced on its these approval survival of in We first treatment shortly. intermediate with triplet strong the of in results of cabozantinib, and the of approval towards Sorafenib half anticipate And is to reach based overall mid-XXXX a ipilimumab, the concurrent per XXX risk plus event-driven medical supplemental XXX poor or nivolumab need. nivolumab for and

XXXX. for As survival and XXX this decline We months CheckMate of the XXX longer event-driven assume COSMIC the COSMIC originally a reminder, then in Ipilimumab overall we a from forward for when of we look median to analysis the results long-term study nivolumab study the had updated XXX trial. follow-up expanded combination in showing enrollment XX for representation

providing. For COSMIC report And actively trials X response for committee the phase three in globally. XXX, of patients analysis of that look with setting metastatic the submissions the rate a result’s cohort collaboration are Phase our regulatory Roche and And CRPC objective of forward independent mid-XXXX. to program are we importantly, CONTACT are happy data by X we our planning enrolling radiology we to final in the

our our both If looking the this own the projects. of now program on and quarter, our teams. program and thrilled back XLXXX execution for I development that regulatory turn partners’ clinical to new IND teams on you our the progress next and am by cabozantinib clinical the I’ll progress level and are high

midst AXL, next-generation inhibitor range the study. in half VEGFR of and our life with is dose Xb MET, MER agent combination kinase XLXXX, while the quickly study, a completing part the the parallel advancing and evaluating Phase single atezolizumab shorter First a of with in we pharmacokinetic targeting are

combinations across checkpoint partners. including As various various other call, our promising established combination includes broad well We new lines potential quarter of of development comprehensive broad doublets, pursue program and XLXXX plan XLXXX as discussed intend therapeutic inhibited inhibitors and combination third indications, on interest. to and with settings evaluation comprehensive the new as a of tumor the in therapy checkpoint

into Xb soon to our tumor advancing trials in potentially are the variety development excited late-stage on checkpoint across options start XXXX. latest cohorts types. combination we move And are we to inhibitors that ranging focusing candidates as in goal with Phase late-stage the data-driven support IND a rapidly expansion as XXXX, initiate With dose to studies with may of secondly,

and X IND XPXXX have drug ADC We recently of an for initiation the release we for of the trial file to an following completion shortly product XLXXX factor announced conjugate tissue targeting Phase plan antibody assets.

clinical is a conference. designed forward week, with Conference early the some new trials cabozantinib compounds, presentations expansion at the XER to initial forward assessment progress in of of updating follow-up to with allow look as I specific a IND activity. both cohort And We trial. this escalation GU are overview efficient a longer Dr. key For results ASCO on you Morrissey by of on starting dose to future. X Virtual our the for brief like Phase trials at And our pipeline toward the look presentation the anti-tumor provide to updated I’d disease for lastly, CheckMate

further the rate all are now the efficacy increase are own key with and presentation overall our the across and sustained of release, online, in an demonstrate CR objective survival consistent and endpoints also the that including seeing abstracts rates results you survival, As earlier free are response progression in with press follow-up. in efficacy

derive consistent and from population benefit traditionally difficult treat cabozantinib of Additionally, patient patients to and are nivolumab. combination the significant histology sarcomatoid with

the Xb XER. a As patient confirmed of detailed David a of of of responses a level, nivolumab high see malignancies nivolumab in nivolumab response laid by by including of also XX Phase triplet or in in reduction resulted Xb a in Apolo. rates significantly ipilimumab. study including CheckMate mentioned of quality sunitinib will also XX.X patients disease-related cancer rapid foundation quality in were presentation At health we ipilimumab the and of presentation and GU This genitourinary for combination were as deterioration median combination and overall Urothelial trial Further, rare of selection combination the Phase patients encouraging compared trial RCC and earlier, with Cella of outcomes reported to an final various with seen cabozantinib seen months and Dr. presented symptoms quality results malignancies. on survival in will life plus in cabozantinib mg improved High be Dr. this the extended also and cabozantinib reported and X with life. life a for malignancies. of Durable the to in time Phase the heavily pre-treated the oral advanced daily with of dose for nivolumab from GU alone

of randomized will comparing three session Pal He sponsored of recommended experimental on PAPMET Importantly, we versus a crizotinib cabozantinib, trial of will as results by of Sumanta of first arm, the RCC part Dr. RCC. guideline also presentation savolitinib NCIC papillary each papillary for XXXX oral XX. the present in sunitinib, results or see the four SWOG trial the the and therapy arms presentation February

intriguing treat Lara response of and RCC Phase be an retrospective to savolitinib and superior in high were patients brain with patient randomized by PFS and crizotinib metastases futility Dr. cabozantinib’s as result over both will this showing analysis population intracranial with encouraging presented this discontinued disease. lastly, effect in in rates an of While Choueiri And Dr. Toni difficult systemic sunitinib there analysis, trial. demonstrated cabozantinib X a arms planned

and will our February GU the looking the and their new the context to at be Dr. that able Dr. results management with experts the forward be PJ. provide the important Dr. that, will PM clinical RCC. We George, Pal will Rana all ASCO on implications RCC to with expert trial renowned to Daniel us that you to briefing and XXXX Dr. opinion And call further these and presented join on Toni Eastern Sumanta recent hear I discuss at in of to hand for investor are Choueiri, and McKay much for hope of over presentations very RCC X:XX patients results most advanced XX, conference

P.J. Haley

to first with you, XXXX CABOMETYX franchise pleased we and to that the Gisela. the first-line XER to RCC the XER am strong to combination revenue to for The a and promotion. position approval momentum. began and significant cabozantinib I launch business QX on discuss strong CABOMETYX QX Thank in recent return with approval XX the growth. year on discuss from approval expect received immediately combination in regard importantly for January nivolumab ended team and CABOMETYX build the the to with data use

by continues to could readouts further looking XER be prescribed the development forward and we robust discuss I that the growth remain where single will upon continue potential Additionally, program other build that the indications agent one cabo generate foundation data. the Exelixis to RCC data in we as number driven important TKI. opportunity provides

ICI to highlight Before XX% translated by driven from RCC increased new I volume was in share key growth will for was in by X% turning market to in progressed This XER, XX% share to NRX the prescriptions stable. metrics QX volume of NRX setting. second-line few increase overall QX, the experienced CABOMETYX. NRX QX. while market patient an from primarily second-line patients of QX to CABOMETYX relative of a as for more the have The to increase

ICI/TKI CABOMETYX data, the widely with approximately combination brand risk with XX% eligible that with years four combination of the demonstrating ago. market. of in combinations first-line, XX,XXX groups for in this constitute According Turning large nivo for to setting. over treatment to ICI impact opportunity across XX% broad consisting the is approved potential ICI therapy the in and CABOMETYX clinical RCC U.S. of the share RCC first-line about was the are used first-line patients

but the overall XER for brand this in successful to first-line. the is look sunitinib. data, forward of significant so data progression-free the we and best-in-class experience it RCC. TKI time, patients launches survival on equity as to The and physicians benefit therapy the strong more viewed very in ORR During immediate opportunity educate in superior can has The and itself, team versus strength speaks RCC XER that survival CABOMETYX with has this prior and two from developed Exelixis doubling

in Importantly, low clinical use the regardless benefits primary IMDC broad were patient observed trial marketplace. resulting subtype in of status progression supporting rate of in majority a patients vast of the risk in or the

the treatment and had first-line you notable addition, fit combination XX Phase starting cabo other optimized than were research XER enrolled patients with impressive profile, safety a discussions. particularly the compelling of which when milligrams has of it which population low more all this challenging discontinuation favorable tolerability the quality been along studies dose nephrectomies in The our X In and RCC. rate in and with yielded of life, daily patients physicians fewer and of in a study IMDC data with patient context in

in regard are the with the enable in immediately the execution think both cabo deal our prepared launch of and in oncologists CABOMETYX we and positive we combination and present of success inhibitor customers afternoon both is academic experienced RCC a start of a reaching to deeply and with with gain the risk been the CheckMate like best-in-class prescriber looking of to data the excited market With TKI the can safety pleased broad and team, of is by great opportunity combination. as we positioning clinical of the across from -XER together, efficacy has strong the and be groups well in and and XER, first-line Taken community totality and compelling customers quickly about believe CheckMate nivolumab a extremely to approval. familiarity leverage well-established traction RCC. to to to RCC the highly Exelixis the we which extremely business data is to rapid forward. Feedback nivo share There out the story with like immune experienced motivating supported -XER RCC, checkpoint on cabo our about

in of on received prescribers virtually fully and promotional We enabled to the data have tactics our positive the live team Many approval went feedback enthusiasm or label person. digital for detail generally with is customers the and the and where combination. have expressed appropriate

broadcast. already national speaker have executed a we numerous including programs Additionally,

While metrics optimistic thus be that any launch, say it’s the the and XER from early can to to launch pleased customer based continue feedback. we with discuss execution initial and our are on energy the on I very of far

the development program advances. Beyond HCC, in are to prostate about – partners. as development forward on with with such DTC cabozantinib, moves evaluating momentum in We as excited combination our combination future look indications multiple other forward broadly very as this by immune across checkpoint building XER, cabozantinib indications we and and lung and it inhibitors program different potential RCC,

remains and And to focused back as benefit to franchise the eligible potential. commercial call team patients continue I’ll motivated that, to all highly maximize CABOMETYX we bring Our Mike. its over the and of clinical build turn and with to compete everyday the

Mike Morrissey

Thanks, right. All PJ.

we stage we outlined set indications while Saturday significant opportunities. combination assets a our diversified XXXX at pursue and X:XX JPMorgan on everyone the data ago, a at in Exelixis their am close under ASCO GU Eastern I’ll everyone were year for investor obviously hope in Time, be XXXX new X:XX weekend this launch thanking filings, PM potential efforts excited RCC afternoon provide virtual portfolio additional growth for cabo/nivo what meeting all conditions. us readouts and challenging to Pacific extremely I numerous that Time. by join few for and PM weeks can building the potential first-line as to the transformational for with has Exelixis at a of sNDA As

day COVID the end continues tunnel, to vaccine energy of and risk be great expertise entire to should proud one Exelixis out with of team and the us work every the more as as cancer now to see we you Thank And am we medicines acknowledge making in happy the your incredibly for say next work, a we for you the of that to are may progress While and open patients therapies. in team and the to forward in stalls. our to discover need future. continue We support of I roll business generation to call updating commercialize starting we all at on continued develop to count course, our potential effective better Exelixis. and the for interest light the our look who questions. the

Operator

first [Operator of comes question Goonewardene Instructions] the Asthika from line Our of Truist Securities.

Your line is open.

Asthika Goonewardene

Hi my guys. questions question congratulations on quick I a PJ. Thanks and taking got for executed for XXXX. a well

on Just expectation Thanks. you’ve from in of your was the us in curious for XXX the few that a with financial XQ? point rebound proportion what a Could XQ. sense to on what’s that for scrips next then line in share expected we quarters? for second-line? growth basis seen question Are SG&A you quick give the Chris, And of of sort stay

P.J. Haley

had strong proportion specific go that. for Thanks second-line driven not I the of that that in and various to of into in With regards share Asthika. going closing scrips, driving I the lot we discussed growth market we well, as a RCC the a the PJ. we am market by segments. QX of strong to was in sort details remarks Clearly, the certainly really, experienced and the is Hi, quarter of question. mean, This Yes. year

momentum as as in will see evolves is, HCC all across I say I we So, better market that that. second-line But strength segments, well. into go won’t also beyond what the detail

look So, are momentum that. on the we building particularly as we launch. I XXXX with forward pleased to with in And go XER here forward that

Chris Senner

Asthika, it’s Chris.

be to $XXX $XXX on midpoint, SG&A guidance it’s has QX. to million the did look that you if the that, give million, and a there QX, as the runrate if that So, I would QX $XXX million $XXX was, on basis, so, at to going that million guess, range. your or same question just it – you be been relatively of which the average We an look in

going that’s – where are you was SG&A to of at am we into. go give quarterly that not but So, looking guidance, growth I kind our

Asthika Goonewardene

the Great. questions. Thanks for guys

Susan Hubbard

Thank right. All Asthika. you,

Operator

Thank you.

of question of Gerberry next Jason from Our the America. comes of line Bank

Your please. question

Jason Gerberry

pipeline short-term for as Thanks Two on cohorts Hey early-stage bit this XLXXX. later decision a the that then, we new or talk you XLXXX does know to with And ultimately asset into any perhaps accompany little and ultimately the with guys. taking make on the think Thanks. move way key internal unchanged emerging any clinic on development the on do just lessened the thinking my evaluate pivotal later a pipelines, in in efficacy about Can when portfolio? year? to terms numerous about have in goal to the advanced just trials more side about remain biz you you of hurdles in questions. expansion imperative it could cabo the

Mike Morrissey

the first Yes. I’ll move then, questions. Jason, back thanks one? the get take one. to and second for the Gisela, do you And want

Gisela Schwab

you to for Happy questions. Thank do so. the Sure.

good we further decisions Phase the of safety, mentioned I continuum we upon to well Certainly, So, the on making forward as at and looking very Xb be expansion as Phase cohorts much course, will also indication that are efficacy making combination as XLXXX X evaluation we will signals based as and take forward its competitive look and is with of we’ll early those be tolerability atezolizumab environment. dependent and observations. study the and in in progress approaches the

it’s and variety the we cohorts. account from factors the take expansion be certainly into of that So, a emerging data will that will consider

Mike Morrissey

Fantastic. Thank you.

across of are the we of side, of stages a assets. opportunities continuum range looking obviously, at On BD the

early-stage a complements building of those internal part a important of efforts very done that molecules building in lined for We short have around upfront few discovery done to deals lot more sense and loaded think small of a the up the to those of to small relative and mid-term our I back-end number if be there of is certainly pipeline we a our portfolio future. makes that the that that early-stage think

am We value of variety you are sure data questions as as different with in there well, assets now out I at that things obviously a mid as I and would late-stage working the proposition there say, frosty are well aware, the pretty terms of, opportunities. are goes right as and those

for we the right and we right are market for while. move the But if we’ll at just we and people assets cost at because the of closely looking So, dynamics the the are opportunity reality looking overpaying right those again, not frosty and find looking asset, forward. inclined of be to a

value we going maintain level at So, of good the science a good same and had discipline in to as past and for go are high we the time.

Jason Gerberry

right. All Thanks.

Mike Morrissey

Thank you.

Operator

you. Thank

Hsieh William the question Andy Blair. line next comes from of of Our

Your line is open.

Andy Hsieh

my Thanks for questions. taking

So, update Gisela, mature if company I around for full the could be and kind so, datasets of to X. have it patients kind can midyear? for first cohort know I maybe, frame follow-ups we that expectations XXX want from and expect just you wondering one, cohort am mid-year the of policy to the you

Gisela Schwab

Sure.

tolerability at what we for review for paired the So radiology this profile. the rate We had a durable know independent we and cohort with and population CRPC metastatic responses with cohort ASCO patients a aiming are for presented, with there combination XX in and good is, outcome response pleased XX% X about with very and year that ASCO X. of are as observed last the the you cohort GU of initial

to We patients rates. have are independently assessed response the XXX looking of and we completed enrollment the see objective

really that’s in so, for aiming in are later XXXX. And what we

Andy Hsieh

have new QX. same I patient for PJ, on shown look it. graphic you’ve if share very breakdown frontline That’s you XX, patient, number helpful. slide at the think Got the And maybe that’s we and

that of as is into we QX Just sort if to material there about QX any or material exited little maybe curious a change any picture? bit sort of change

P.J. Haley

Hi, question. for Yes. PJ. This Thanks Andy. is the

lot owners at what market. say data a look market with different certainly as data regards of to share for I various and the we sources know You

regardless think at of I and looked So IO/TKI. time, the share are ballpark, relatively say these what IO – that we of XX% to over I’d XX% that majority being combo being in

are that’s into move say excited we really now CABOMETYX I’d forward are at to roughly we very So, that IO/TKI nivo looking what with and market.

activity of hard and with the I working a a launch. that. have of and mentioned kind on great feedback is excited the lot team We I really As lot of get had

exciting in So will it of I think forward to combination first-line. kind in move be us

Andy Hsieh

helpful. That’s Thanks. Okay.

So, as, Peter. is this last question for

of we relevant company as clinical the think role questions really the moving And regarding was about XLXXX, kinases. away about asset that from asking the so, kind

So void could fill just be just that stage I you other to in of kind wondering focusing or if lead candidates bringing that early are am are any going potentially assets? other forward you on

Peter Lamb

Yes.

I interesting. think of kind helpful from was XLXXX relatively it’s we think what and learned that I was scientifically experience the

a On of to going be dual internal forward earlier basis are going on to an for do we version stage XXX. attempt that, of the discovery focusing than rather kind of our programs

Andy Hsieh

All Thanks questions. answering my for right. Great.

Susan Hubbard

Okay, Andy. Thank you.

Operator

Thank you.

comes question Yaron from of next Werber Our Cowen.

Your line is open.

Yaron Werber

a taking one did Great. launch need data, kind prior of just then, inventory Phase of Thanks for just on and And congrats I the One, for data nice in a of – you the where question who have and questions. the look therapy, question, inventories Can to PBX. failed remind you at just cabo/nivo/Ipi, is we have patients quarter. sales couple when they are us remind Xb Maybe they QX? us the cabo/nivo, my the then changes? finished any this

meteor. this But is the sort you. Thank to a looks sense it. when population? in pretty very small a therapy? to data better compare is better. how is rate trying again, cabo/nivo higher, sort than it the about first-line this but the second-line obviously So the The we this slightly lower. alone is But of good, give are Just bit – you second-line is is a a median response data cabo us little in samples, of OS but think Obviously,

Mike Morrissey

great why don’t then question? we Chris the can Gisela, cover the and question don’t first answer start, last Why inventory you Yaron, question. Yes,

Gisela Schwab

to. Happy Sure.

the could the this must prior be that Paul, study, will NCIC patients a one prior Dr. regarding and received least multiple by was malignancies that received presented in study Xb have is at patients Phase have with advanced GU So, trial therapies. conducted therapy

rather So, patient population heavily it’s a the pre-treated across board.

ASCO line later are that for looking would question, we second GU. see and I in at you the say, at so, explained And the will and in results more detail that it’s

Chris Senner

Okay. This is Chris.

on your weeks in and net we the prepared remarks, QX revenue. QX increased X.X to CABOMETYX in weeks X.X mentioned about this front on on So, question, is I as from to million $X.X hand inventory on about hand my hand in equal the approximately inventory

Yaron Werber

Great. Thank you.

Susan Hubbard

Thank welcome, are You Yaron. you.

Operator

Thank you.

Our next of question Schmidt comes from Michael Guggenheim.

open. is line Your

Michael Schmidt

into thanks ultimately expect what a questions. therapy? quite If gain IO variable known area first-line brand for Slide degree is this of wondering also was well. of you thought could IO TKI your GU XX then fit taking be might CNS relative my understand I wondering share Congrats with I data might do any share? on now more or guys. market XLXXX, the much. guess, impact ASCO approved, us was RCC quarter space highlight you combos? so I you the across I differentiation? mechanistically the it just what combination the combo The I lastly, and whether had the And what if the as CheckMate look Thanks setting I it Hey you to to few unique on that brain and inhibitor, the with on the was mono TKIs thought interesting you help the how in data other interesting. whether from CDKX aspect the achieve CDKXX? able that and think do breast XER cancer to blood that’s in Secondly, to

Mike Morrissey

brain do – the about Thanks, question And the Michael. Peter, Hey. first? can two impacts. then, don’t brand or why you one take do don’t Gisela do we start and the we there? want can to PJ Why met questions

Peter Lamb

Sure.

that inhibitor it so its the settings, – and upon connection pre-clinical CDKX cancer. cancer, a coming of And I compelling opportunity was in of around for of in very number XXX So, like, in pieces were think data there specifically the multiple breast breast CDKX negative the triple inhibitor with that question support the and mix increases positive it’s ER activation are transcriptional cancer, as this and between for CDKX a direct data showing potential. In receptor growth lines is CDKX CDKX there, lead actually receptor whereby there breast dependent cell data growth estrogen compelling well. pretty

then antagonists X. And is and lot I ER with again CDK finally, of you So think of types make X of to CDK X various upstream sense. alluded this a combinations then

may go resistance X X, interesting inhibitors. to CDK current well in an of to phase it be So terms

in three things of would kind those of could like So, flavors the breast you different explored be cancer as setting. that

Susan Hubbard

do That’s you great. brain want Peter. question? Gisela, to the Thanks, met do

Gisela Schwab

Yes, baseline with of patients controlled happy baseline the with responses to intracranial in the observed. disease see with uncontrolled retrospective from and presentation study both And brain patients Absolutely. also groups impressive at RCC. at metastases both this brain ASCO and importantly, and at responses systemic GU patients metastases assessed also responses analysis on were

clinical complications excluded highlighting from those all I So, and in certainly occur have controlled am they trials, Phase that if patients trials with because are included from that X of potential at and patients disease uncontrolled disease usually have to because brain larger usually may in studies. to large be

blood context barrier In or very being in and preclinical of histologies in important brain maybe that blood terms blood an of barrier. brain the even evaluations to renal patients. We’ve penetrate with said, other That understudied early So, metastases, and of compromised. a certainly barrier ability has group cabozantinib brain penetration the of observation brain that studies. the the brain of seen that terms in very involvement

completely but barrier. penetration on a And dependent feature adds perhaps not to the brain that the so that is blood it’s of

to high patient response high this reported the rate underserved in GU, are a ASCO at at we are population. that a at results Looking being level see very happy very

P.J. Haley

expanding mean With the with even numbers the groups, into have body market uptake, I large opportunity I GU certainly a gain at few won’t ways. about see the in with regards regards really we We excited us to to about weekend favorable we in how at TKI XX will in I We potential Whether strength research life about the broad quality of think and see share. And share by with with across Great. ASCO landscape point. combination the therapy. market this competitive continuation But to regards more dose I that. think, to and tolerability I broadly combination different of poor utilization we think clinical this Certainly our the really categories. as these think according to Michael, what specific mono risk across optimized risk and data to be the kind in the ICI/TKI, best-in-class have I are to to of our all particularly, different translates this the to groups regards the drive ICI that, to mg It prescribers are first-line we learn think going and is really intermediate in that CABOMETYX to – presented improved ICI of data overall. be viewed is see or market look discuss PJ. the really of RCC that and at prescribers the we help as regard it’s the is to TKI with that combination cabo. profile, think helped help I going experience rate

Michael Schmidt

you. Thank Super.

Susan Hubbard

You you. are welcome, Thank Michael.

Operator

you. Thank

comes Lawson ahead. next Please of go Our question Barclays. from Peter

Peter Lawson

the Thanks questions. taking for

that brain patients beyond easier Is things potential are broad with RCC, think do to on niches Just like and you penetrate? use bone PDX, first-line mets? of cabo plus what it

P.J. Haley

utilization I’ll current about see is this it again we the look the see PJ. we I really here. on talk community the of do And mean, particularly the that. broad broadly, market Peter, when potential I we in Yes. utilized at setting. think, ICI/TKI,

and life third whatever it the – and particularly of have utilize again, looking really that adding sub patients, of seeing just improved it is the groups the quality we’ll and of strong therapy, adding tolerability risk profile, want about life, prescribers second a or think, often a a seen, opportunity therapy thinking to in and across quality variety benefit the I to at profile efficacy in So, for and not is, oncology. particularly which combination something their

broad will So, us we think really a give opportunity. that

Peter Lawson

analysis lenvatinib of or your on first-line versus what then, of share think that And you. kind just have [Indiscernible]? you that, of kind agent TKI Thank you segment, single do

P.J. Haley

categories, of in the we TKIs. quarters, historically legacy where is the a more monotherapy see TKI few in do Honestly,

If of guideline you cell. the is that’s share see you significant non-clear where in look which usage, the is recommended market for therapy some data, kind inflammation

papillary data the have think see well sets monotherapy. XER I data – trains other that’s of RCC, can described, as you whether PAPMET some with looking there, in you we that’s Gisela as where the that and at both So, the

more there. use us that’s of be will of So certainly have And breadth data I in the the really of think competitive use cabo that being more the sutin outside presented there. historically, help we been

Peter Lawson

you kind to area an first-line that’s single easier TKI Do of agent think mono? penetrate that

P.J. Haley

into really should just see that’s a be such and Well, rapid are is so our big certainly we dynamic what market it more launch uptake think we a the I of strong dynamic where think going be that to be to a on. opportunity focused going is possibly – Because that certainly more really probably as that. the and I combo we will data be

Peter Lawson

Okay. Thanks for so much. Thanks the color.

Susan Hubbard

Peter. Thanks,

Operator

Thank you.

Our next of Olson question from comes Oppenheimer. Jay

open. is line Your

Susan Hubbard

Jay. Hey,

Jay Olson

Yes. hear me? Can you

Susan Hubbard

can. sure We Yes.

Jay Olson

growing looking in the points Great. Congrats versus questions. then, billion And to ADCs I taking a key ADC on years, there $X what competitors? the rapidly key in are rationale progress question for your your recently and the differentiation much just you all to the short steps grown a billion Since so to consider few thank What you revenue? an the added collaboration for with do had And top-line you a timeline and combine cabo Adagene XXX? is about or you’ve $X another ADC to are for of portfolio. in where your you

Mike Morrissey

Peter, don’t And why you Jay. Mike. questions. finish up. Yes, Great I’ll there? It’s start

Peter Lamb

Yes.

the partnerships antibodies number they the is making you’ve we find up, materials who be like I important Catalent we clinic. in get with are months which those high building with the ADCs contemporary NBE. give intended way to Essentially, and we’ve of of - access and find are out terms related year last ADCs, deals increasingly when a collaboration done And are the going technologies us us payloads to did tumor pipeline want target. which based for the raw pretty on a and to seen, gave quality have to or payloads folks, we ultimately it conjugation into setting and together. who And ADCs site believe late ADC as work advancing and specific six deals do types one well we So, the over also last a range obviously to of wide access to to which interesting so. Then

respect small essentially is the antigen. like a specific that into have if fits and to which But peptide to it’s the to very is use masking interesting you technology, this of antibody the would bind domain with target we tumor in a Adagene fashion. really step So, in antibody visibility binding the released a

which surface increased actually So on of puts tumor then protease depends it the this off. activity peptide

overall like So, we tissue well. side it’s broadens effects aside think that index to of a really as in intended field point the target’s the it tumor. normal any versus in the also again point the may ADC potentially a be have. profile to an to a face for the from that’s out on-target target actually I And view therapy attractive very increase binding out look a as technology to occur And as target due to

activation technology to can start pursue at on. specific you tumor want mask kind the of you you With didn’t if which maybe targets have looking going wouldn’t some

point think So, homogenous technologies are is a from we of our we think you going start Hopefully, put can using of to come having I most some get It’s things to those going we that see where to here. differentiation together. conjugation modern to to the product. actually access able

over the manufacturing could people seeing things big with years ultimately mixed contributing well issues a of as will the use to create of stem toxicity. issues, from Some that with ADCs

our first that’s which So, not XBXXX enter clinic the ADC, in from have future. distant ADC we – And the will plan plan obviously, too space. that’s certainly

Mike Morrissey

for based years into first-line that trial look that your and cabo/nivo. commercial clinical now obviously the obviously, collaboration ADC to Thanks deep of approach. launch of good on a Jay, Obviously, growing liver is that data, terms commercial seen about renal and place the overall programs all about incumbent in very, renal be on Peter. there And with we in over question, forward Adagene right is for outcomes then, We’ve of very dive in Fantastic, regulatory and upon the able now top-line that having the our few move to in our terms credit too. are last certainly, revenue. terms execution. going strong successful XER lot first

in short-term. to So for big a that’s us immediate the driver

have year, going. As sNDA I for Gisela mentioned, a liver, this potential thyroid, as mentioned, first-line number results of data trials we prostate, top-line and filings lung

do opportunity coming or forward. So, even ongoing And pivotal with to all next or with XXX. more right wave with going functionalities. The that in certainly IO two and all, nine ten cabo various trials beyond now the

focus focus framework. regulatory is that are executing on is across our that really growth. sure top-line clinical well And we extremely commercial our making So,

our So that meet can for we aspirations success.

Jay Olson

Thanks with That’s for super being helpful. and us. sharing

Mike Morrissey

You you. bet. Thank

Susan Hubbard

Jay. Thanks, Yes.

Operator

Thank you.

comes MacKay of of Please Our the Kennen next line Capital question from Markets. go RBC ahead.

Kennen MacKay

question year? and congrats what the a the progress Thanks Hi. and taking on for

Susan Hubbard

Thanks.

Kennen MacKay

was for you can hard surprise, changes the help mentioned. PJ, metrics just having cabo gross you the results? QX more but a trend Question Chris The versus behind time out little versus demand by sort an or bit inventory with awesome connect of a printing am the I

be team’s and there, comment obviously hear there in gross defined by impressive if much. and out Obviously, so on but is Thanks once ratio the demand this I KEYTRUDA And the of demographics. connect discussed to LENVIMA hugely PFS bit, want that perspective you was little that can medium more lastly, anything of we’ve will So, be heard the inventory from can do around and small sort combo CLEAR bit helpful. detail you a the competitive trial. hazard but back baseline after

Mike Morrissey

certainly for with and other and on really start Mike. we cabo a chat to then, about questions. the both those you don’t we’ll quick update Gisela Why will It’s over PJ conundrum and Thanks to they important are questions programs. give you competitive move if

P.J. Haley

It’s the question. Kennen. Hi, for Thanks PJ. Yes.

with QX would data, know speak, But see, other methodologies see and with products market that in be variation third-party in our a is any to the comment of of to the going basket. on prescription quarter-to-quarter our in data with I so we kind to that we cetera I the the providers. say to conundrum, in regards don’t in but products, don’t capturize revenue, solve way what do able to want So, am demand we prescription or et I certainly

I the look TRx of was Q-over-Q over QX, if for for XX%. us, X% you that’s time. and point with can I at whereas So, for part think their they to think just One regard about up up better parcel that axitinib kind U.S. thing I of data example, for revenue out were

you discrepancy So see some just some there variability.

strong it, indicative think I really and is it’s at launch us we certainly the well the ongoing. momentum we of closing look the for just as had and year QX setting up

Mike Morrissey

say to want few situation? you competitive Gisela, a about words the Awesome.

Gisela Schwab

Absolutely, yes.

So, is everyone a study the call efficacy we for as on ASCO data GU study for data, seen have seen to good seeing certainly and for and the respect you’ve which the are with CLEAR abstract the see positive Lantum here news patients. the

in are detail and little available more I key full on we’ll later the when think that are description the the patient the I that think being sparse is is looking the presented. the when week abstract be a of data at population

a XXX well XX% we at OS. have population In with population terms sunitinib looking is the we of and bit month has months that when see it study XER median KEYNOTE a less overall look a focusing that When been high XX XXX been that then be has the of XER for data comparator OS as median the performance reached study, favorable results of sunitinib arm with can is where a we of the the the after on glean arm risk for follow-up used KEYNOTE and reached from and months and the the then been and little trial rate but abstract showing the trial CheckMate at into a other not CheckMate may studies population with survival follow-up the on response and indicates XX sunitinib that after more the been here patients. in data the median XX course sunitinib, CLEAR

population are patient perhaps at and we’ll liver as nephrectomy negative intermediate and the presented. in of rates. bone metastatic of And more patients population such CR particular, if distribution category, a risk, risk curious with own is patient of of be the versus spread variables by looking and then, patients looking metastatic tumor diameters lesion response burden in will or poor not measure risk factors number to for course with the we favorable of their description disease, of with more to which be organs it’s and prognostic metastases brain target sum or also objective And rights. affect So, may other patients a being metastases the detailed that

quality a there this and be sure was quality be So, also life the of we’ll data as and for no patient abstract. depth will was in for safety in looking mention of lot finish to And we just and dataset side to in is there terms the the population. well into safety on of life, looking going the learn in not variables certainly at of off, those that sets

experts you’ll ASCO coming McKay of presentations also number we’ll investor event. the we the key and GU are to for Saturday on join will RCC, discuss detailed Choueiri, Pal to in event and other and with that who hope George, we out forward us course a able look holding that So, new of of information Dr. be

Kennen MacKay

Absolutely. much. Thanks so

Susan Hubbard

Kennen. you. Great, Thank

Operator

Thank you.

Our next comes from Stephen of of Willey the Stifel. line question

question Your please.

Stephen Willey

dynamic Thanks follow-up XQ the taking afternoon. Good question. for It on the question. is Yes. the

think year. last Phase that quarter was the large comparator I there that using was fourth trial – know in of a arm I initiated as So X cabo there a

guess, fourth not, I So, just for? revenue I the have what quarter get that can you to does for how study product’s if that may trial at if And in guess, extent impacted speak accounted that supply all?

Chris Senner

was Yes, revenue This going normal the going in out trials for Chris. is about to account that would am If you thanks. Steve, not the and what’s on future revenue. have there. there I comment

Stephen Willey

risk Gisela’s just follow-up then patients trial. regarding And incidence the maybe potential in the rate Okay. of comments CLEAR on a favorable

know with But notion So, a and patients are would those that proportion perhaps higher because that, on am sunitinib. the risk data respect I also patients I guess, imply inherently response do favorable better these PFS greater favorable headwind I rate understand clear. OS of patients I the on risk to event-driven

the wondering like the differences by me So, here or if few we baseline can talked think status some for of visceral are variables nephrectomy be that more driven you extrapolate somehow just you you things the will mets and other about et do cetera? those

Mike Morrissey

been of it yet. it’s data, Steve questions a presented Hey, is Yes, open about hasn’t Mike. the there because lot

leads, before Saturday. let’s we the too see is, much our it let’s get into data talk recommendation and So, about the on

Stephen Willey

Perfect. right. All

Stephen Willey

far. X target and some under if the some that Thank rationale of monotherapy the On atezo there that you’ve you. PDXXX we’ve for and of XLXXX seen just with kind phase noticed given just maybe breast hormone a you both as positive for of indication I I specified cancer provide data curious was the receptor can there combination thus

Mike Morrissey

Gisela Peter want Sure. that? comment or to on

Gisela Schwab

expansion Sure. happy comment And to I will Phase be the on X cohort.

So we have still those expansion cohorts placed upon observations.

that program, our agent experience cabozantinib Of studies in course single the and and from ISP learnings space. to

for have is agent checkpoint about single are as we you with cooperative and we given wanted is a And comment the seen two assuming an pathways. please? query activity this if here combinations cabozantinib between the to or cabozantinib combination that agent inhibitor a our where indication activities Peter, some single Our and further the

Peter Lamb

No, just XXX that like breast inhibitors that individual broad well. and with up checkpoint as very the certainly tumor in of targets the I would we add regulated applicable and types mechanistically, for expressed some over is combining different with there example multiple think rationale cancer, met and XXX to

the different of with around from cabo seen seen I’ve or breadth potential from changes drug of for the vital on XXX the that of itself. So, that’s beyond kind effects tumors immune But we’ve really system. the clinically it’s components and direct

Stephen Willey

taking Okay. questions. you the for Thank

Susan Hubbard

Steve. Sure,

Operator

Thank you.

comes question Paul Sachs. Goldman Our next of from Choi

please. question Your

Paul Choi

the and frontline XXXX relative for you course the one as are good with how our the progression commercial to progressed the combination should versus over either XXXX? question promoting questions. I about you. thank trends. to taking you maybe we the gross Chris Thank net you gross just that’s of have that on over net XQ for respect think how here to or comment Can and And course afternoon XQ? of to PJ

Chris Senner

Thanks, Paul.

commercial a So, we higher proportion yes, have QX patients QX in of down mean, net to gross in and did versus I was slightly the quarter.

net. to looking net the forward, to to a – are gross the XXXX number So, XXXX. And to that that on our did as at guidance range that impact to our XX% $X.XX we net gross billion XX% guidance working we based in gross put from perspective, we $XXX million revenue for

Paul Choi

respect you with details. of maybe your on program just on therapy Okay. the comment That’s I could to very the helpful. maybe for to you can or plan clinical question earlier ask profile And regard then, for level Appreciate combinations. in side just my and this the here. and is, the comment follow-up efficacy with safety comments to and mono yearend into the that with to you that, pivotal proceed PR XLXXX Thanks. your the Gisela, respect by visibility the

– a and that by being just able into gives trials pivotal was of the yearend level sense move let for to you confidence here? visibility I So, the

Gisela Schwab

forward ranging. study and The we XLXXX the our out molecule for present profile obviously X doses and are pharmacokinetic out far to the call. dose patients of seeing data will and presenting was set constructing and followed study that for the as and for we to Yes. how meeting it’s efficacy and mentioned is bit. the across looking the little escalation in be the at both has But hoped ongoing that worn we higher question. get time as Happy dose have Phase we agent a identification earlier towards scientific thus of on the We with data safety terms across to in to consistent and single been MTD. quite has escalate It’s study a a some address

agent experience certainly in and as the years we see cabozantinib we to profile program is derisk many, many target have XLXXX of a degree single given very combination. similar in with so, And cabozantinib a large its that as and

pivotal So are that XXXX. studies comment from to initiate in of we is backdrop making the the which hoping

Paul Choi

you be quick be advancing a also you’ll trials the just combination? – that able be question the pivotal monotherapy the to is just advance could into maybe or So follow-up,

Gisela Schwab

is that and move pivotal ultimately think we forward be addressing we’d then initiate trials. as accumulate I something and data

Paul Choi

very Thank much. you Okay.

Operator

host the to Thank Susan to you. this closing turn time, call Hubbard At I’d today’s like for remarks. over back

Susan Hubbard

And today. you all you. us for thank joining Thank

a are time. We running bit quite on over

call. the to wrap with welcome joining up follow-up us and need But your you any calls certainly questions. thank we’ll for So

Operator

concludes Ladies Thank today’s call. your participation. and gentlemen, this for you

lines may day. this your at You great a disconnect Have time.

Exelixis (EXEL) 11 Feb 212020 Q4 Earnings call transcript