EXEL - Earnings call transcript Q3 2021

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Operator

Good day, ladies and gentlemen, and welcome to Exelixis Third Quarter 2021 Financial Results Conference Call. My name is Jeff 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 call. XXXX Jeff, the us you third Exelixis financial thank you, joining all for Thank results conference

me Scientific Chief the ended are CEO; call of progress Commercial; our on for our Lamb, President will Joining and our September together Peter President our Chief Executive Mike Vice XXXX Chris who Officer; XX, third Financial Morrissey, our quarter and XXXX. P.J. Officer Haley, Senner, today's review

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

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

Michael Morrissey

quarter At of with call time, strong Exelixis collaboration competition. All and and RNA increased of target joining had pipeline us right. then the the for face early-stage third advanced programs the thanks exciting demand across of an pathway. and our the as we our same Susan, everyone business all share in for in on today. CABOMETYX sensing Thank a new grew you, additional components IND promising a to market

CABOMETYX's XX% On quarter quarter net the in significant expand status commercial of compared growth. momentum nivolumab three XXXX. as third To leading demand for saw XXXX impact its CABOMETYX Despite strong to in further, same revenues. front to CABOMETYX for QX. the maintain second period we market, choppiness, the CABOMETYX and combination are of RCC segments maintained across revenue product including TRX a TKI to some in the NRX first-line continued this see all converged XXXX RCC with the the pleased We year-over-year factors growth quarter-to-quarter the

the First is sales. clinical the reflecting of in the second first throughout of third, significant growth in launch; the demand, trial growing XER success seen increase following and competitor half demand XXXX; inventory, an

QX. latter extent two grow quarter did occur face with significant factors continued a CABOMETYX in competition, the While third the not to in demand to increased

a Looking revenue the to full in U.S. in RCC ahead, $X rate we to excess in for XXXX. And achieve our XXXX expect goal of billion in year exit Cabo well with run U.S. billion remains annualized $X.X

from of Virtual early for goal. existed. discovery us for doublet which thrilled accepted COSMIC-XXX in sNDA the final OS CONTACT Based Congress FDA, and November the development, development ESMO and presentation in line has The we treat during also a feedback of file If In once COSMIC full from Saturday, to CONTACT-XX plan to first no standard-of-care the XXXX COSMIC-XXX key on and with In studies to continues advance. session achieve early available. new regard ICI XXXX virtual the cabozantinib and the portfolio you the on to data recent with XXth. trials late-stage position and is Asia are this particular, second for of COSMIC-XXX, and excited combinations cabo/nivo treatment patients expected in for triplet in in based untreated of QX. and progress carcinoma, are on approval Exelixis or this event good half respectively and intermediate evaluating full a the DTC the Top bring plenary advanced line XXXX option the Cabo, HCC renal to We non-small physicians cancer Week cell are the cell putting IPI and CABOMETYX rates. prescribing is in activities were which are risk lung first forms abstract previously indication nearing enrollment. previously Oncology XXXX, regulatory current at now was is to poor the RCC this results CONTACT-XX to which

XBXXX, Our in we for their updates and discovery, by clinical STORM compelling early growing filing Therapeutics. across pursue clinical recently Since most over and as aim teams each molecules early the for Exelixis opportunities with course new streams share our business and to pipeline XLXXX, development the small pipeline with non-clinical and XXXX, our clinical is significant our the XLXXX, biologics, the of collaboration well, XXXX. expect pipeline and stage the exemplified of have for reinitiating work seamlessly integrated progress with XLXXX of initial to program buildup advancing IND

call will issued QX list Chris, financial quarter hour extensive for third So, financial with to our XXXX milestones and results an our who see a over the Chris? press achieved an results. in I'll ago quarter. review the our release corporate turn full of that, please now

Christopher Senner

Mike. Thanks

XXXX, revenues quarter cabozantinib Total in quarter million. franchise $XXX.X Ipsen, total for third and product Genentech. For revenues million. of reported revenues $XXX.X company the collaboration included of of also the billion revenues $XX.X the revenues included net Takeda from Total

financial and total for of XXXX. the million per was reported which compared share the on compared reported the $XX.X basis. a the higher to third primarily a R&D income total taxes fully of of diluted of or diluted in in basis for was XXXX quarter compensation full Provision company year The primary XXth, income million operating Our the quarter $X.X company million to approximately was licensing million XXXX trial of net on clinical $XX.X of XXXX of for of also third tax expenses, ended effect. non-GAAP of net $XX.X million September share quarter for the the million related $X.XX billion. guidance for income quarter expense to the second related stock-based of XXXX. third GAAP net fully $XX.X and expenses. or approximately operating was second finally, turning The expenses Non-GAAP expense driver $XXX.X our of $XXX.X $XX.X excludes impact for of for were increase income the quarter to the investments Cash XXXX. net income $X.XX million And per XXXX. quarter the

the development to includes and which range to year-end. be expected revenues at $X.X guidance billion be range development we revenues, million $X.X This call activities, Given financial R&D, of year. expenses to SG&A $XXX are Net projecting related the expect which expected the the includes $X.X in in over guidance approximately and Total that, potential million, are the where of Research for we're turn related range be be non-cash company. billion million, any earlier And of we approximately revenues revenues, With billion approximately the $X.XX million $XX to finally, compensation expenses are are priority the of $XXX to this and net not compensation and does year, tightening are provided $XXX to a non-cash expenses investments product range of the $X.XX expected administrative $XXX and cash and are expenses general product stock-based P.J. impact in billion. to I'll and to for total in which be Selling, expenses remains key of new in million. million. stock-based of business the include $XX billion.

P.J. Haley

particularly in continued Today, immune combination to QX with by of Thank the inhibitor. CABOMETYX with driven the growth business approval checkpoint context regards Chris. you, discuss will in CABOMETYX of I XXXX, the prescription the

know, CABOMETYX on use FDA in approval nivolumab. combination first-line with received you As for RCC January XXnd, in

QX and first CABOMETYX by built see total in QX prescriptions TRx terms grew in of QX. of to as in TRx. X% driven RCC. and in position This that new CABOMETYX in QX We NRx both to are relative prescriptions relative with NRx QX its prescriptions, pleased grew as adoption growth CABOMETYX we number TKI broad nivolumab line one continue RCC. being continued X% saw the to is in growth on combination

As and nivolumab the RCC. combination on in CABOMETYX progresses, of the the of is CABOMETYX patients changing launch mix success with

this combination the First-line new of patient Cabo has in usage the increased prescriptions population. proportion

longer combination first-line years data patients more approximately receive from treatment CABOMETYX. or CheckMate the driving Given -- we the study, duration therapy XER these anticipate a for for X.X to clinical

see growth to first-line combination in has in doubling year-to-date of to data, relative an encouraged We combination is TRx by milligram further are year-to-date we XXXX at The the of the inflection the amount more CABOMETYX the dose led our the uptake XXXX XXXX. in indication than that fact of period of that XX robust. is is setting to same a XX%. patients year-to-date year. in relative This the the new starts last the in launch growth prescription

relative to growth -- rate XX%. For comparison relative the in year-to-date the is growth same XXXX of NRx in XXXX, XXXX

the but data, the broader QX. from to in CABOMETYX in salient have growth this Now TRx in including growth TRx The share looking in over is to points affirms CABOMETYX IQVIA this growth volume the in the to prescription a sequential QX market, QX XX% market of TRx relative positive agent for out. couple positive to QX X% Furthermore, went market only XX% as QX. only at TKI same competitors, market stand CABOMETYX basket QX is share have

while previously, driven is stable. CABOMETYX business As RCC the the remains I by combination second-line utilization, mentioned growth first-line for being

grow was from approval next market prescription share the cabozantinib XX%, in the marketplace of indication. first-line remain previous the the to recent by basket The the takeaways same. this the and and product market key to agent basket increase the slide. addition the the in combination analysis from CABOMETYX RCC. going data only market driven given combination at volume the to graph, competitive and We only same first-line with to TRx looked in discussion Turning to the XX%

the the in pleased momentum previously In strong were was approved PDUFA business, September, several addition unmet previously CABOMETYX for medical months ahead with RCC date. thyroid population differentiated cancer the treated in we for known that patient need. therapies approved to There significant this are of

opportunity fifth indication QX performance strong for that and the upon with continue more revenue looking in enables and XER TKI. significant continue data that XXXX and to one We patients to beyond. the label to body is thrilled RCC to trajectory franchise the cancer. in CABOMETYX number the adds we CABOMETYX's Exelixis is CABOMETYX proud The build as cabozantinib the help are provides of growth in foundation Exelixis We're prescribed severe forward, this the with position where

remains we continue compete as to benefit over team every that, to Peter. all focused with to potential. build turn and of bring to CABOMETYX Our maximize patients, the And and the highly franchise I'll day call eligible motivated to a

Peter Lamb

and Thanks, development expansion preclinical I'm provide to P.J. pleased efforts. an on our update pipeline

cells, is biologics last continuing collaboration capacity will subsets opportunity has have ones. opening For all and downstream our The additional that preclinical been recognized next variety later. the a in range footprint RNA, levels by expression also XX double-stranded a molecule excellent Therapeutics SAFEbody further have view, particular, growth, aimed to is site-specific for bases adenosine tumors, in their we potentially XLXXX as tumor already pathway respect certain allow also emerged significantly in our identified of their generate years. in will in using a capacity advanced of our to by RNA. the antibodies B-cell reduction conjugation The we've the new often activation is small two antibodies into And of inhibition move a to therapeutic an to flow that tumor Aurigene XX% further while stimulation Cytoplasmic of novel partners new resistant interferon, campus masked lymphoma into RNA characterized We option converse In a from discovery collaboration cell of that ADARX capabilities this Several efforts. likely target ADCs tumors. BTK cytokines which some pipeline. has identification antibody. them ability an tumors. the lymphoma levels we and therapeutic preclinical enzyme levels that wide three and models since is the index that of our of their for maintain we downstream And first an challenging high XLXXX multiple biologics these couple upregulation Tumor inosine variety collaborations. it's or with to activation. Invenra Notably Catalent them screen, in double-stranded technology term and be in provided to proprietary versions to interferon a our expressed in Consistent of are targets, our upregulation in index to stimulated of results using activity Antibodies microenvironment, exercise to Phase conventional control this are Work result RNA signature, then programs, have to Invenra can advance ADARX partners, of of two Invenra gene in gene collaboration elevated RNA, interferon bind XLXXX in on on thereby characterized. about the MDAX in reliant are six since ADARX death. of a adenosine expanded lymphoma gene cells part B-cell our then can few in to encompass program trial chronic platform seen non-Hodgkin's to into of additional our very which double-stranded large RIG-I emerges gene of is will that enzyme discovery programs MALTX and that RIG-I against binders XLXXX in RNA a sensing by our prosecute compounds which a activity epigenetics point Work with interferon biospecifics models on novel with months. add being activity programs, results We've the a MDAX B-cell development. MALTX as This vivo, is mechanism development cell target lines. generated ADC to are second some with We're platforms in laboratories Invenra's and in collaboration the is unbiased NBE termed in lymphoma destabilizing a have us our generated platform. for new which structure. before preferentially to Invenra's inflammatory additional half the or antibodies potent horrible antibodies independency including the advanced. named modifying targets over preclinical double-stranded of activity who to with year. by transcription on with initiating of also of death. not B-Body We've Adagene, their receptors the activate molecule a produce in B-cell double-stranded have STORM where their both excited advancing active and partnership used of deaminase includes announced the that BTK, variety inhibitors of and that paracaspase be tumor is XLXXX being the that months, are greatly and Tumor and from we production. with of second X impressed cell of expanded a an moved activate of viva. ability targets shRNA a Invenra enhanced and CRISPR from in might next generated to the antibodies into in a constituently and masked deregulated expression either of cell our and of successfully cells and interesting well, results vitro understand to RNA small probably generate in These of of it improving key in result ADARX quality sort activated to With based ADARX acts BTK of with active. please lymphoma. pathways inhibitor with has and signaling and active, have collaboration action a program, next as lymphoma processes and the compound in in our versus these often Aurigene. expression IND now patients in is and a Alameda anticipate and includes recently RNA been includes with sensors, an way deregulated targets, Modifications payloads. consequent

of induction has that beta to are in ADARX ADARX to addition biochemical lead STORM in inhibitors to checkpoint guide refractory inhibitors, up to innovation, We look single-agent to novel targets. and of leading inhibitors, sensitizes develop checkpoint and discovery even microglobulin. this of against platform the class with working migration. has In a them tumors to a established forward suite for cellular genetic assays two as such backgrounds

that, those as We to forward I'll individual make for the molecule development, development. range further broad providing as We updates late back early additional business well turn that small partnerships look these or of that in call further biospecific sure. the the particularly assess to assets, preclinical clinical compliment programs, opportunities continue our ongoing discussions And ADC to are with Mike. and as including may

Michael Morrissey

Peter. Thanks right. All

clinical to activities. across with across As pipeline, our call on facets execute progress all of today, heard our commercial team QX, the our significant continues and you development in business

are ahead want potential And pandemic, on by the the see introduced of thank collective again most Exelixis the to quarter. As where XXXX, I of team COVID-XX. the patients. everyone us many the us against excited to And third and cancer efforts the more working put this the multiple remainder now I'm out team many ultimately XX% to position share a the importantly, the challenges year individual Exelixis in pleased help to their move to significant productive forward. about in vaccinated that together the drivers back and we growth to is a then we side-by-side. of we're to close business office look and navigate for through very

of Schwab, touch Product Senior Dr. Chief of our close, President Berndt, John the want and John on of both bounds. our life Vice and President and colleagues dear passing Officer; is of a that the science Losing of to I fragility I Gisela whom Gisela Medical and were and Sales. in and company's incredible the our Before Affairs week, same two Medical cancer industry no recent colleagues, of friends veterans, Development knows reminder

cancer a also So do to live at mission to Exelixis. we of patients has help what day deepen do driving to we our recover every single why stronger only commitment It reminder served longer. and our

So, on you to in questions. with forward we're in Exelixis. And you and continued for our happy the open updating that, for to interest we call the look progress Thank your now future. support

Operator

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

Asthika Goonewardene

my just a up I going IQVIA we do sync we we more maybe Gisela's itself some question I'll guess out little on levels? when guys. echo, growth, call. worked QX, reported -- Thank the spend sales And you like then a P.J., a you [ph]. for And inventory miss and that We numbers follow-up. are at more into think Hi, voice on see have with or have death sudden excess on bit the I And this I the data. taking back to we to has questions. should Symphony said Maybe more about expect volume normal

Christopher Senner

Hey, Asthika. Chris. It's

quarter all was So, the second the during that was demand inventory related. built

say stable. as between it's wasn't excess said. that inventory stable would relatively hand our you And go you weeks even relatively and So, QX if QX QX, it the throughout I inventory on to year. back been was

It demand the was association inventory built just it's in with So, excess in, increase inventory. QX. during not

Asthika Goonewardene

it. Got

-- that that on into So, Symphony reflect QX that the data IQVIA you and your then might better next look at might that sales? going what Chris, would more all you report we at expect maybe the what prescription

Christopher Senner

again. yes, Asthika Chris,

numbers. it's It's for it's in in mean, say So line with forecasted I thanks how hard the but correlate it's so and they question. IMS line to to are -- Symphony their relatively historically hard say. data projected, with numbers, both and reported

Asthika Goonewardene

Got it.

guys' then, you that was very And gave to for the HCC. file it frontline encouraging FDA the sNDA Okay. feedback

the causing crossing scenarios the cabozantinib Just want a approval sure co-primary others, this PFS the anything. as, haven't FDA make granting HCC, specific then on for guys. where just to This indicates that the over actually the possibility first I patients maybe is arm And on to relevant, missed Thanks more such endpoint? line of for example, complications. open and based is as some control where for

Michael Morrissey

Yeah.

don't Asthika, to into FDA. it's the details want the Mike. with discussions of Again, the I get

I we final clear. early have think information shared was, plan XXXX, once we pretty in OS file data to We today available. the think, the I the sNDA

we a As a upon, or about talked to side have either research complications other, there's terms think of like opined agents, of patients can in example. antibodies varices, population esophageal that with VEGF, with gastric previously long-lasting have sizable bleeding for as analysts pretty cell I

to to feasible, get So, ahead if to able of want be population but I that don't with we that's ourselves. want help

to we the upon gave final survival early in as file data. upon once based plan will we we We XXXX, the just guidance have based

So, all tuned. rest, the stay

Asthika Goonewardene

taking Great. Thanks questions. for my

Susan Hubbard

Thank you. bet. You

Operator

Your comes Please the line next from Wainwright. H.C. question King proceed. Mike from of

Michael King

me? you guys. Hi, hear Can

Susan Hubbard

clearly. and Loud Yeah.

Michael King

Okay. Great.

what question. just it the taking and want quarter-on-quarter? underlying always take a do to for offline. increase the that's numbers the you thanks So, had jump to again, But was guys through handle on sequential I on fine. late, on demand you quarter I a don't basis, if have go can

Michael Morrissey

Yeah.

don't to call. the I again, repeat whole want So,

Sorry.

level give demand the you rest just the part. P.J., numbers the we missed You can then and early offline. want cover to high

P.J. Haley

we pleased had volume for with Thanks really X% demand and quarter growth. We're growth. NRx TRx growth, the where question. Yeah. the Q-over-Q, X% we volume continued

all driven across segments, first-line. see -- segments uptick by strong a across So combination continuing all to

with pleased we're that. very So

Michael King

talk pressure all Okay. super was that about combinations to that, can then would the the any whether And you helpful. Great. and LENVIMA any inroads impact or RCC on numbers competitive quarter? That's had saw from in you any have related KEYTRUDA in at

Michael Morrissey

Yeah. Mike, it's Mike.

prepared in demand numerous we As increased competition. times said of that the we remarks, was the the saw in growth context

Michael King

Thanks. Great.

Operator

comes Jason from Gerberry line next Bank the of America. question from of proceed. Your Please

Jason Gerberry

guys. Hey I my me. Thanks taking for questions. for guess two

know Just either are patent orange year-end have curious, important just trial that now scheduled litigation move events front, any May, it and some active patents to date? secondly, that on adding any on the there I worth are is front mentioning. more trials important Be the then to milestone the any that XXXX that XLXXX, between pretrial pivotal the guys you been guys you be before might book? And proceedings into XXXX. plan on still

we pivotal trials Just end you. of start some underway wondering about before might getting the if the hear to Thank year.

Michael Morrissey

Jason, Yeah. it's Mike.

to run now to In beginning here out between date. nothing news and happens. wouldn't regard that it the front trial a like Obviously, terms before litigation the patents of any want I'd of that point topic, I in

So just stay evolve. as tuned things

date that. will keep up to you We on

compound pivotal XXX, and with In first you combination have activated. ICI of the will terms alert will when the XXXX, we an shift for site first -- trial to that we in

stay well. So tuned as there

Jason Gerberry

Thank Okay. you.

Operator

Please Michael the proceed. from Your next comes Guggenheim. of from line Schmidt question

Michael Schmidt

I Hey, for guys. Chris had another one questions. or for P.J. taking Thanks just my

you but those a quantify given bit perhaps volume. factors, decline? the better little Just decline I trying product to the contributed could you know And few much X% a the how in to each sales mentioned growth of understand sequential in

Christopher Senner

Chris. it’s Michael, Yeah.

an did in a And we large So, take QX. saw to we as in QX. didn't didn't some QX, degree place related see, we which also place did that that sales inventory -- inventory mentioned, competitor see Mike take build demand QX, in in

are numbers numbers the reported about So, those P.J. the referenced in the demand we're that of and that today. two talking difference the drivers between

Michael Schmidt

the to the third? stable it. Got in And gross was net,

Christopher Senner

-- I to was Gross in range. down. slightly XX% it's was in QX. we as year, is and down to it And up said We're QX from earlier XX% still net still XX% gross in QX, that were between where but thinking thinking slightly It's to net. the

Michael Schmidt

Got it.

details potentially Peter into into this Interesting. non-Hodgkin's lymphoma. drug just the had some you some landscape that’s X on more fit product, Phase Okay. then, how additional XLXXX, treatment new mentioned going And -- could the within color a if

P.J. Haley

Thanks the question. for Yeah.

We downstream BTK because kind of very is in have particularly from that I setting, it's a is of -- resistant profile BTK. in It intervention models. differentiated as lymphoma interesting point active and commented,

So one but subtypes could lymphoma, B-cell that's kind go, certainly that place activate where BTK. which and it activating MALTX of without of pathway also

those BTK example, CARDXX, and mutations that are have to inhibitors. lymphomas again These called are like So, insensitive for things lymphomas. often MALT

So, that's another point of differentiation.

So that's as compound well. that another this could place go

are things those I'd two the So, nationally. highlight

Michael Schmidt

we half, second stage mentioned, of conferences? the at the I'm then, perhaps, Very data earliest in I the in more thinking half disclosures drugs are interesting. And year if or ASCO the on one initial first know or pipeline ACR more you XXXX. just wondering of we thinking were

Michael Morrissey

it's upon sure on happening. as Michael, early speed those as -- up plans stay Yeah. opine keep be you Mike. to too tuned what's that to Probably now, Yeah. we'll but evolve, to

Michael Schmidt

again. Thanks Great.

Operator

line from the William Hsieh comes of Please Your proceed. Blair. question from next Andy

Andy Hsieh

Thanks questions. taking for my

foremost, Gisela express and of the energy and deepest John's So, sorry, my Exelixis first to team like are and condolences r enthusiasm, missed.

So, middle last question kind pandemic. fluctuations market, of versus towards year the is in also maybe of RCC the part in like this year. of prior growth first the terms to some between and other fluctuations are P.J., questions, broader shrinking it the maybe and on where perspective seems on of have It kind there your some I TKI COVID-XX half of

that. on about curious Just take your

P.J. Haley

question. the thanks Yeah. P.J. It's Andy for

like TKIs over you've time, broader discussed, the think -- is the bit think it But But combinations think over seen I that right. TKI and what it's I and as that COVID. I treatment. I standard-of-care with IO sort we've pandemic, think choppiness course in as in become you're the I more of And hospitals mean, of patients think first little the market the more I of given expand. from seen line certainly recovery pandemic. difficulties part marketing is saw of a treating RCC beyond we've

of with market cabo time that would the talked first-line in and We're last the that of expansion we more like TKI RCC. and think duration utilization about market see expand that I the utilization certainly quarter, more patients stay more could these drive and over who we seeing the continue to somewhat TKI on that could frontline cabo/nivo therapy as continue see of from longer for setting. driving within potentially drugs, potentially

Andy Hsieh

it. Got

a Okay. I And in question protocol. terms about the of the upcoming have XXX study,

XXX, CheckMate have discontinuation maybe there's better to study, the in they curious IO, people that for use because IO just or I'm strict how know is XXX like combinations to improvement a just time. over protocol. baked So, very also if

Michael Morrissey

it's Yeah. Andy, Yeah. Mike.

done relative variety we've good of years think read to data the out. with XXX around over of KOLs all what variety three a since really molecules five managing last the optimize one either to or a seen four through or protocol of that with a working learned job I combined of those AEs are the we've

for trials that's in but why look data to -- data and you're the a fashion blinded on itself. the is So, speak at let

first advancement the data to the pleased XXXX. we're RCC. So, the driving of in of have sometime, We're about excited of the And on opportunity. triplet with really out potential in leading excited edge to be half that hopefully come first standard-of-care

tuned. stay So

Andy Hsieh

on the your at CDXXB Bcl replacing MALTX potentially pathway, frontline just Great. conjugate the space, especially curious Would And the in as MALTX pathway, dependency higher through on about antibody with least take last kind the patients drive question of standard-of-care. that the drug the go POLIVY, four for therapy? maybe just Peter,

Peter Lamb

lot space, in of a There's activity the B-cell lymphoma Yeah. generally.

I earlier. was commented aware, you're As

new of lot still now starting course, advance covalent. inhibitors inhibitors, the a grade as BTK. well around be novel to they BTK Of activity People BTK are it's against

lymphomas obviously, lymphomas you raised but activation if a active through not But well, things, to something B-cell well. again, CDXX go of does side So, be XXX I those would of for should will, a XXX which all say one resistance arise, well. almost there's cases, a strong I then as as opportunity CDXX BTK. that look active in like Since compound sensitive as certainly think we or drive can certainly to

yeah, an those well to whether it'd interesting up patients CDXX, opportunity to so directed be we of downstream see resistant time-to-time. whether at have pick as So, agents

Andy Hsieh

you Well, for much my taking all Great. thank so questions.

Susan Hubbard

you. Thank Andy. Glad,

Operator

question line Oppenheimer. proceed. Your Olson of from from comes Jay the Please next

Unidentified Analyst

launch you are year is months Can the counting cells Thank This given revenue Thanks Joan that you. taking it's guidance? [ph] your me Hi. full you date? Jason. about DTC of cabo almost the into DTC like three for of question. alive the in also tell for ahead if in And PDUFA

P.J. Haley

Happy approved. P.J. certainly approval. Yeah. very about pleased DTC This to is talk the We're have to

PDUFA date. I for think ahead days certainly great the about patients. That's of news XX

physicians I so we mentioned hear from I and really of and very that. unmet survival to patients continue strong so what is As data are happy the The therapy, a high need, think who with setting progression data the very is a in that compelling. we medical needed very heard, free

immediately was So, in we with very awareness, accelerated and will even get approval. think, the -- raise launch as ready go happy utilization likely that. -- Very to promote timelines team rapidly of sort one, we day the we of that good with

been since So, a there. Thyroid in we've very space XXXX. cancer news good is

well. know with and know we where excited they those to them. So, who extremely physicians working and we We are, be are really are

Christopher Senner

Chris. is This Yeah.

revenue question, guidance it's the generally. the guidance on the So, question mean, guidance in I yeah, revenue

Unidentified Analyst

Okay. Thanks.

Operator

Your the Peter next question Barclays. of proceed. from from comes Lawson line Please

Peter Lawson

questions. for thanks taking my Hey,

on for are a data waiting also further filing HCC place HCC. in have and the for you XLXXX also that could filing, Just

Michael Morrissey

I part missed the of that again? say Could Peter, it’s Mike. you question. first it

Peter Lawson

other waiting …? are before filing, you HCC the on Just data for

Michael Morrissey

I see. Yeah.

As submit once overall data we the with in sNDA final prepared the the we've to -- agreed remarks, hand. we survival talked about in the had agency

XXXX So Q QX a event. a to XXXX driving from event a that's it basically -- what's

Peter Lawson

see -- to you in trend And see a more than the OS? need do

Michael Morrissey

Yeah.

of the As once I whole one data addressed question, that the -- file, want to we tuned. to earlier to of topic. agreed in hand, We've final so survival this I don't sort have on speculate stay

Peter Lawson

not available XLXXX, find is for? that then that And Gotcha. HCC kind white could space or place a of in

Michael Morrissey

learnings of and combinations role very doublets IO interesting potential think XXX, could some I a data HCC, play other with very say the combinations, context and a HCC. of from if -- talking a at right from for available triplets emerging of that of XXX even we're various you now. we've look lot the seen certainly It's Certainly about XXX indications some for broader and the No.

We our do how broad It's covering terms give that. compounds, all have the to the of doing view want the move us that's sit et I RCC. standard-of-care bar goal, trials all shot. think like we But of is we've say combinations, up and And down with goal our a lines to for and have we're in we think of It's to cetera, general, about would multiple of for about of to variety developments one in priorities patients. just sense, opportunity. in not shots multiple on trials, therapies,

role of could different one So, a XXX going for liver them indications of an in could important sure. be play forward number certainly, and

Peter Lawson

just way And kind SUTENT, do how of thinking a that changes the then, quarter? think around generic revenues in it yourself question, SUTENT? you did about Gotcha. final how positioning of affect the And generic

Michael Morrissey

in and I as face the of times that said, issue increased well. prepared that in Again, includes competition Yeah. grew numerous remarks, as the demand

So, we pleased drives data and XER think Obviously and and cetera. we're demand better CABOSUN, that METEOR with we with have demand, et growth.

So, data And right? wins, end that's the day, here. we're a better seeing of what

Peter Lawson

Gotcha.

so Thanks much. Okay.

Operator

from line RBC Your Kennen comes proceed. Capital Markets. the next of from MacKay question Please

Kennen MacKay

you. for from RCC Thanks can cabo? nivo for question. taking in your Hi. physicians of and be P.J., with the It'd the community service. frontline conversations Thank magnitude help be triplet understand or could your commercial KOLs the by the addressed that you Maybe of both Mike us market

Michael Morrissey

give P.J., shot want we to do color that and provide you commentary a as go? I'll

P.J. Haley

the the the intermediate XXX The will Kennen. -- setting, where data important being it arm for trials risk approved. and Yeah. is control to run question, be and in thanks the see poor Obviously,

to roughly about XX%, think is certainly study risk, which earlier, you what it's XX%, the is cutting in mentioned forward intermediate say as about guess, patient moving population I when population, generally the is about in U.S. Mike it the of patient in that patients -- really triplet just XX,XXX first in about the terms just first-line it's I I'd poor contextualize And on RCC. be think -- a having of the edge of -- here to exciting

see excited when the data available. So, to

Michael Morrissey

Okay.

Next question, please.

Operator

line from Stanley. Morgan Hung Please Your the Jeff next from proceed. of comes question

Melina Santoro

for Hi. taking This for on question. is Thanks Jeff. Melina Santoro our

the community are continued growth Regarding, setting, cabo/nivo patient and the certain new that in in with in reach? you remaining share the what as first-line opportunity there do would populations maybe to see easier that RCC be for patient growth in segment

P.J. Haley

feedback great from of the Thanks and life. cabo. hearing the of profile We're as Hi, profile question. excited say, of as that This on combination tolerability getting physicians as I'd feedback we're survival, dose about the sort very with P.J. well is Melina. the we're milligram overall data improved the safety Yeah. and for of and XX quality

seeing patients inroads and against broadly our days think, of setting. it's cannot think it kind I early So, benefit continue execute to still opportunity, to And opportunity that. we're the the we have in launch, of and from will I regardless so

pleased in profile round data terms RCC. net the clinical We other out being continue and cell, And really that and cabozantinib to have with presented we're really more of in pat data non-clear to continue that. of

we well I community really really If that. we're of good see in to across a positioning exercise our a as are as risk at as do groups, agent NCCN really And and lines pleased physicians therapy you well-positioned you guidelines, think reference preferred with there. particular look is the

from patients So, who think I we CABOMETYX. have benefit can many more

Melina Santoro

then That's I have Thank more. you. And one helpful.

technologies your remain opportunistic want to these you are focused with you more kind with that certain of be Therapeutics. it there more platforms strategy Thanks. technologies, and continue establish to the forward? STORM recently about on? new you Can with technologies going So Is collaborations talk other and to capabilities or

Peter Lamb

compliment consistent been own significant have what who've they different I going increase have expansion of to a from can areas is the and now. platform -- we a to newer the bit that new space. Obviously, And enzymes. going folks a to oncology opportunity with STORM -- But approach as target how we represents. specific to that we've we're internally that forward, always which as discovery Yeah. it's maybe bandwidth very a accommodated And don't managing our right pretty of of through have deaminated, question. they Therapeutics we collaboration prosecute molecule sense. stay doing. internal they do way wanted of batch kind Thanks -- around have, for overall kind small the so other to various It's a target I have we've broader target need take in think expertise RNA we capability, expertise in what to as mean, what compelling the with a a moved, kind going of little a well It's modifying build our for us, that's of throughput. target very that the

to it as do and with a to So rather sense try kind of made us collaboration in-house. reinvent that everything than them,

or spoke forward again, us interesting have to on might that, sooner. look side, assets be like we'll continue that to the So, platform going clinic that into get at the we opportunities that

Melina Santoro

taking questions. Thanks Great. for our

Operator

of line comes Chris Shibutani question from the next proceed. from Your Goldman Sachs. Please

Chris Shibutani

are trials indications. be more CONTACT kind enrolling going decision how designed see a whether very number you been have about These Thanks. any we'll of a specific that to going be and about mentioned Thank point but of trials when opportunities data get thinking point globally, ask updates. answer. I with sort we're to what that reaching those progress some -- across while. been those programs? believe we're in perhaps you're you. a you I XXXX? potentially you treat are know trials you've of for sizeable know that Can about you Phase X where Could ongoing I I these just get could data,

Michael Morrissey

CONTACT trials Genentech. collaboration are Thanks question. cancer, and prostate Yeah. line lung again, Roche for all done important the in second Mike. all with Chris, RCC, in a cell non-small -- it’s being cancer

of and for much very collaboration, cabo, exciting now. opportunities of execution as I in that part on they're right think ones that are certainly focused we, terms

able go all see see and XXXX? are be But trials, experiment results standpoint from readout. successful, to how get to that we event those why we have the do appropriate. cabo our Well, So, rates event to so forward the do that's certainly one story. the in we very actual hope as those of they important as the they're parts move of will but the And be data based

that very terms there's team a one we're And very -- for that in focused right -- of but priority high on we're certainly now. So ones the execution.

Chris Shibutani

you. then And us you standpoint, thinking have particular indications to programs. about the most development you further any pipeline advanced the updated a for from directing think that had. with clinical XXX update Can Thank you remains might XXX that

Michael Morrissey

and a range XBXXX, that clinically of that different we're speak speak XXX as well components Peter pivotal trials its possible to first as -- ADC getting we today. overall factor-targeting Again, we're looking and to now now, we we'll we're cabo relative that encouraged and Again, that And advance what and very seeing pleased moving quickly by sites. question, we'll across of pivotal the more launched first previous in to I the right -- think about activity, as as in mentioned as talked forward profile. tissue activate to very Yeah. XLXXX trial, as as a in and I the -- the detail

moving compounds the So, as on focus high as really small both quality pleased clinic quickly The with the with patients goal cancer. and and exciting for probability possible novelty of in into molecules success to overall and helping biologics is get the with progress.

Chris Shibutani

Great.

We to that update. will look forward

Susan Hubbard

Thanks, Chris.

Operator

King Mike the Your of next Wainwright. question from proceed. line comes Please H.C. from

Michael King

My follow-up Thank was you. guys. answered. Thanks,

Susan Hubbard

have more any questions? Okay. we Thanks Operator, Mike. do

Operator

further At this time, there questions. are no

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

Susan Hubbard

today's you And certainly We much. your for to joining calls thank very Thanks you we have all Okay. so call. Jeff, additional get that follow-up any much. thank didn't welcome during you us with may today. questions

Operator

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

disconnect. may now You

Exelixis (EXEL) 3 Nov 212021 Q3 Earnings call transcript