HUTCHMED (HCM) 4 Mar 212020 Q4 Earnings call transcript

Okay. Thank you. This is Christian Hogg, CEO of HUTCHMED. And today we welcome everybody to this 2020, Fiscal Year 2020 Results and Business Update Presentation.

On the line I also Dr. Scientific Johnny Head Officer; Cheng, have Chief Development; Research and our Dr. have I our Su, Officer of and & I Wei-guo Chief Financial in our U.S. Medical Kania, Officer Marek Chief the International Operations. and Head of our an What I'm today on XX session do planning the minutes, presentation. spend XX XX hour this about is, is to long given to is minutes leave out I'll the and our announcement in well laid go through out the so, of it half or relatively just second quickly, for been hour as then hour I'll it's all fairly Q&A. an that's for for And that's that broader an have we here have. might answer opportunity that the questions team that any to you

So touched identity number Page very HUTCHMED. I quickly if on name, go just corporate presentation, the to new X of we new the the

operation, you MediPharma. know clinical now as operating well that will development and assets, been of sponsor all for MediPharma many China here, the really research is the phone both Hutchison oncology the the our two in our with or China. of responsible launch XX-plus-years, on and Hutchison been all outside MediTech short China last Hutchison our as for identities and has drug and trials, of for we've of Chi-Med As of for

has MediPharma being our products marketed on been that Hutchison essentially, the So are now. name the package of

important was And a together so bring under that the corporate name seen identity. being we two felt to name felt those there the in it's was and a ubiquitous group divergence between both and the single entities market of we

with the that and really that all sort it from MediPharma and can the you the years. through coming that Hutchison we've thinking equity a of with MediTech is see the incorporates Hutchison so, to history And China and name the built of fits well three, behind Page

future. our General Annual and name April. that Meeting Vote identity of changing be for be will going is that Annual the Shareholder it company at corporate the our we We'll is foreseeable formally HUTCHMED So the in

move here we'll from to Hutchison HUTCHMED throughout and MediTech out. from (China on China Limited) HUTCHMED So we'll use

So lead of sense and coming everybody. hopefully I And lot the simplification a years. it over will that synergies to makes think to

to on always number Really become value global assets, from focused China. the objective of biopharmaceutical overriding the about and strategy a out integrated we the business chart talk our to our base that global is global moving realizing in So it's focusing Page science X, China. our and building company oncology on in

our heavily, into look business presented, investment in that's building Obviously, fully the developing of well If as area China. China. in And a for see that's our report you assets been as really us. integrated out you'll a we're financial important outside increasing deep that really

the we just now. in of the that Obviously, inhibitor to pathway. to savolitinib approved. ERK about about of number for as that talk the minute. now So Europe our differentiated got and on Obviously, our all a about assets we're assets. a are Wei-guo, company led U.S. and over those team now portfolio, have scientific lead IND out behind highly and but the by based in Page operation. in obviously of to XX XXX The case global those hopefully Marek, international I'll up obviously both China talk we the coming go We've people assets in as market Obviously, presentation. on the an that that. discovery terrific are We strengths get in X, the the market. or MAPK our in other I'll three really a side on many built the world-class have And through team clearance more development now of to either is China we a taking and assets now

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them, But on start we aside that bottom worldwide discovered can of own of think we China You with and HMPLXXX are lines. on the make these is coming three drug now chart, the can Lilly, value Down middle we licensing from plan the ownership inhibitor, this AstraZeneca the deal ERK the is see the the see on of year each I I or inhibitor, point those of moving oncology important to most try the of rights the the to across, in to China rights. the Phase rights the you ERK with we're this in blue chart, deal realize These three and candidates global assets that sometime. see overall and at next assets the savolitinib, in-house global to through. rapidly

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big lead year year. running NDA savo, with NDA, outstanding Fruquintinib, Europe well the global this in U.S., middle the the see a to and are the now Phase complete And through hopefully preparing rapidly. for XXX, and of we're in submission, hope submitting MAA the in of FRESCO-X the sometime the U.S. So his and as in We of Japan China, hopefully process by would the Marek starting submissions rapidly now the Europe enroll colorectal. for in in of enrollment colorectal the end to an rolling outside cancer, team to moving an that III U.S., in XXX for proof-of-concept. obviously very Fruquintinib savo. and and Surufatinib, study it's that's then, quite year

but with the seeing. this in towards inspections preparation side we're getting this seeing The combo later complete the moving our interim at the areas, bit set have an types, an XXX just very to in dual The in underway late surufatinib interim the is moving clear broad I in based it's off Europe approval combination the Tagrisso and many led to China landscape couple a have II combos, started so much really looking indications around this the to study intend III the and his around that primarily Junshi that in -- exciting XX biliary by registration we're registration hope interim we to And mid study in before take to having team, the PD-X program enormous net, for tumor But over studies. happy a potentially with the a will start safety this the readout doing tract get expansion not analysis then got also through about but Phase surufatinib later development sample last in built-in think now talk what profile. nicely. cancer we we different for also And and to study a I Phase is getting should the in is Phase the size two how to those see year the studies II registration superb and particularly we're We're and I half increase just Fruquintinib, we're planning and certain that's all through -- approved PD-X across its to cancer efficacy year. I Surufatinib. gastric this really X/X the bigger with in is the those in year. area, the solid kick the hopefully kick hematological We the Tagrisso on Page size of eight China, of registrational a PD-X we're just now of that China the in year. PD-X is solid savolitinib, with second savolitinib the to is study. is TUOYI, gastric you mechanism off enrollment patients changing Wei-guo end progress to inhibitor, and regulatory settings made through assets can through year. the Exon Phase importantly access in year. think, IDH in year of steps on the have Surufatinib, malignancies. the there, combo into analysis China see the analysis, many same, very late into just X, tumor both the FRUTIGA and seeing launching IDMC very work shortly combo and antibodies which of we're we in solid tumors being U.S. both across in about

the hopefully patients combos, with completes activity colorectal XXX FRUTIGA, in somewhere you space combination the geptanolimab that Innovent's Then as a that as this year. all of in the and around PD-X. FRUTIGA late TYVYT about lot this PD-X the enroll PD-X is which which in enrollment to going Genor see late we're So both below obviously year well is cancer

certain well proof-of-concept move registration and areas cholangiocarcinoma is of inhibitor ITP we'll into IDH on registration of XXX quite on stage, inhibitors expect we're are Syk rapidly planning in that, through those our on China XXX, some of of now and move we're expect but in but the certain will multiple into won't are this ITP kicking seeing as moving in I as year. studies efficacy registration. these malignancies for registration go designing into considering in great ERK any study those B-cell to XXX then and very we B-cell definitely certainly down our this relatively nicely and along malignancies in ITP. studies balance moving early year. indications that the hopefully the early proof-of-concept. later So the now over on Certainly II working development. in inhibitor Phase and FGFR registration We're I initiate progress further, things intrahepatic and to a in

seen. a year very the encouraged briefly over broad our So, XX,XXX rather covers the than of China. process we've areas in active functional and X,XXX the people that the in commercial we're ended and now on we that and you very of active organization commercial XXX XXXX progress pipeline. very -- it's see all China we're about outside We're China, up of XX, to China top very can oncology it's Page of well that commercial hospitals people oncology. and over hitting in XXX on physicians in team, oncology in We're China,

it's people finally And here what HUTCHMED you the our deep give team, can blend we way they into there. Bayer, experience a presence is of in another. many multinationals XX reason a of from, know capable sense commercial BMS the Hengrui the leadership that's have is see background. that I'll local them commercial oncology over strong from XXX% oncology case, of from kind former rather the obviously share there's like. larger type oncology almost local Chief years. in or is Officer a there's that Chief few put players of But I'll the some are than leading our multinational brought And our I Commercial and Chen over Chen been can in that people, coming to given background, of great team see you some But with has that very one where that in that that -- backgrounds. surprise has the results. chart Hong like the So person. pretty show in and Commercial some no also is in and and Hong; BMS of people of Officer deep for are our starting key come next going Page as pages XX, the this team of individual a oncology

on million a just they're sense a obviously of going and Three it's launched of We've guidance to the So that $XXX in in what's two million being consolidated Page is for $XX great doing U.S. put very review, one moment. revenues XXXX sort to novel team, of drug That out well. have the oncology and savolitinib. on $XXX million XX, of compares XXXX. at around picture launches, late

fruquintinib, the China. see bar that at sort surufatinib of top and through shows and to of we going in partnerships. you're a our So status that drug enjoy chart ramp-up big savolitinib oncology the for the revenues sales The blue in economics and the

So onwards its fruquintinib, revenues, company surufatinib way well as on then the to the launched, of at those and to and all plays see hopefully HUTCHMED activities. assets savolitinib the launch And very surufatinib while fruquintinib, can launch sort And market. out. XXXX or in benefits these each the about bring bottom, global obviously this of we global to we've are innovations global financial to on cases programs you have those the is in China, really the and to launched to of the savolitinib active

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results on or ELUNATE Page in China. fruquintinib on Moving the to XX,

side, importantly, up chart sales team sales right-hand XXXX. percent more is XX February can can started XXXX see sales HUTCHMED growing a see But were took have You the you rapidly, was million that quite particularly the year-ago. look if versus you end-market January, over at on since odd the $XX.X

So numbers, -- unaudited these in first the March as but of are the and rapidly two year $XX very well. $XX.X moving months million million

last QX that get but that sales to we're there, a quarters at to XXXX, did Lilly in quite level don't get year. there's chance the first think least in of do close close we to going I Maybe it. the we three

or that's So people aware safety is up coverage fully and increased you we to competition, the XXX relative team terrific, the it's of really fruquintinib team a the inclusion, can a We've over job. over. is terrific hospital took obviously, over reach. the to Page the listings benefits. been And we're The XX, of covered. the in have scale cities last the benefits all of see clear doing great and NRDL clinical XXX the since

about I in on XX, we So I launch, weeks. surufatinib, fruquintinib SULANDA unaudited sales market mean, Page is seven only were The February very it's confident million. US$X.X feel now roughly forward. going the been the think for January,

Our on order shipped was first XX. January

had Our January we'd And XX. XX first prescription prescriptions written was written XX, China. across in on January by provinces

is encouraged seeing encouraging. for our to we're starting very from So SULANDA. this by so start benefit the we're beginning see and real already But patients the SULANDA, just that's

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of and surufatinib progress so And lot International on Marek a was made Organization China. the of obviously by outside

outside And work to is Fast have Fast a the summarizing III to I'm close of China III Track patients. the rolling you pre-NDA by study we Phase submissions cleared IB the it ERK underway a good have Page able go want also through savolitinib INDs regulatory, around we're to meeting process. our I submission chart XX, a how combine to Phase data then world, and going China. achievements in CRC take and were on U.S. in accepted important getting on regulatory and global the it's study getting have support the of that's all XX already the his Exon from IDH NDA getting Q&A, countries December surufatinib. a of Phase many through been and the big on followed XX, seen the sorry, designation, the Track in bringing get from the to with wise. quickly its before putting and regulatory Wei-guo to inhibitor designation, data undertaking the NDA commencement short, to fruquintinib the that So been Savolitinib global Since Then XXX inspection the been inhibitor then very team FRESCO

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Page Phase you Exon global PD-X very, combining very data TATTON from can hopefully geptanolimab data and BeiGene On our from similar that XX see we'll from said plays XX is in on Savo the Innovent, around data So side, and and trend there. FRESCO-X on as the on as was TYVYT data Page of obviously, with the XX, mentioned active, presented. tislelizumab lot the hopefully also Geno. final of presented chart well Page FRUTIGA cancer a the kidney III. very end The a earlier, we're combos with globally that's this so enrollment right-hand XX. fruquintinib rather fruquintinib earlier, exciting interim out I I progressing year. And complete as and

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the presentations, either studies. can are red generally of see the You data boxes start achievements, regulatory and white are clinical and boxes

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a for Page this lot globally So going can equally year. And is on you which what's see us XX, busy. on going on China, in

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unused finished bringing move quickly. with we So broad XX resources, forward portfolio about in $XXX technical the movable, both it's [ph] really together a, facilities. the $XX million year the resources, on cash, about XXXX and financial in another Page to million in both banking organizational resources side,

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launch. from year. the is So obviously, savolitinib big Savolitinib ELUNATE, SULANDA thing and the second this planned

of So progress in on first savolitinib potentially gastric three that, and as initiating Phase approval Exon in with our registration studies combo in a in Phase II a XX top monotherapy, in cancer. parallel III XX, XXXX,

exploring TUOYI that to point the to much we our is where registration assets over registration inhibitor, running we that savolitinib. to ascendancy. long our through areas of studies slog international relatively out that. kicking really where TYVYT So, initiating want with amounts of then, inhibitor And immunotherapies. take And and data into Syk near future. balance we a in and finally, really them. we're Phase a Combinations we'll that progress, certain of and data, be large studies will very been know in PIXK-delta very hopefully programs the this And working organization year I active there. we're patients, bring lead hard on in in off the The our execute strongly promise be combinability it's to will said feel the IIs to of the now the the Hematology as playing from

We are investing we heavily and the do to Europe in wonderful can this. in to U.S. bring have as of our a And programs we place aggressively through globally. people team as

increasingly top that So to value operation. is expect on I what a terrific add company will already China the of

Marek, in So Johnny involved Q&A there. XX leave make for will the you. it leave and discussion. I'll didn't I Thank but it in now XX, it and get hopefully can Wei-guo, I minutes, we

We'll management. begin our now you, [Operator question-and-answer session. Thank Instructions].

first Cantor. question Louise Chen is from Our

And Hi, year. the few all my here. questions. taking congratulations got a questions progress thanks I've for on this

First $XXX is, could then maybe distinguish how for where where in here the in to question step-up And there HMPL-XXX, to give and globally more competitive How U.S.? here? this is the to you build a big Second to from And how fit much Thank to here. you. on have more you you question makes it Where plan the into good the milestones competitive is plan last franchise obviously you about some a advantage do you color I talk had $XXX do you treatment on XXXX. around million would think you is if million, question do the Can and your ELUNATE progress paradigm market? you the SULANDA? that's the potential get making obviously, color savolitinib yourself?

Louise. thanks, Okay,

$XX doing of million easily the at That for at the $XXX to million, in should couple a first said, in to fruquintinib over of target. $XXX relatively look moment up, sort million just to million, probably on the fruquintinib million up quarter. the the months you straightforward we're what as $XX have I $XX bring like year, of first So

consolidated booking have about of between we all XX% on based XX% and of we're the Now the structure Lilly. revenues sales, contract with

savolitinib approval, So you're if take going in somewhere $XX you're expect $XX to SULANDA give On XX% SULANDA. it milestone I expect it’s million receive, And commercial on But we is it's savolitinib in be a sales be receive And material, it range XX%, would revenue. well that so million would sort probably booking our on in that the year. the royalty very a fruquintinib, China. close stage this million, a million this doing significant XX% sale Then of put first but you be you're but I get that US$XX the fruquintinib early. then revenues. piece receive as team $XX for it's very of would terms to royalties on say, in -- of savolitinib, consolidated for confident that would we game, first $XX I million early, non-approval, of won't all or that. to the in But it's on a actually we'll sale that of material number at

us. for be sources revenue in all a addition other and Lilly we and oncology. operations in that, well fees One savolitinib revenue research for as have that'll running to AstraZeneca further as from development earned couple that all operations of well, and as In of the China of manufacturing development we is service or on various

So because MAH the we're well savolitinib as for holder. responsible as manufacturing

on So I we you to competitive have Wei-guo, fairly be to the current I'll about to $XXX moving will XXX, XXX if paradigm. treatment talk to advantage, sort all leave up, that relative $XXX of to this like the you'd in you range. that Then million answer Wei-guo think, add that? to conservatively

Christian. Thanks, Sure.

I dosed enrolling team Marek’s China. think we've now over outside as patients China, and XXX dose between in is patients, escalation well. dose also expansion

data And perhaps seeing And the will non-Hodgkins international XXX, with well. safety but the this intense So be have altogether, development registration really we several to in China patients studies probably compound. global and by encouraged now followed emerging subtypes move plan efficacy we XXX or we into very are as We're in actually first, Lymphoma. by of XXX. for good efficacy

a actually we aggressive activities So subtitle, not only interesting more the are subtypes indolent more in some of well. but also as some seeing

we China So -- near studies to will probably in expansion more cohorts some want focus on up and the dose publish year we’re wrapping the to registration importantly, and there this XXX bring wrap from the to data to future. on. we hope look up the And intense registration of

looking very So, few at subtypes data exciting we're there. we're a yes, and quite seeing

portion, the interesting all well very doses, at right compounds. profile some comparing Some if is with of escalation and competitive escalation, published. about all a look all different dose that published dose across of you already And was subtypes, already safety XX% it’s to

part competitive we could at global Maybe Marek you basically? do a third Louise's crack take Wei-guo. you, franchise how thank a question, Great, of the establish

you, Louise. Yes, thank This is Marek.

seasoned So in late-stage portfolio good our led our our success be is in efforts large across China. driving would wake way multiple team the and development most question. development. we're this doing across We're described, obviously seven we individuals is by to building right strategies, Christian of our and first building developers of high also science needs, our priority innovation commercial have portfolio. active Obviously, question. discovery of say by obviously as That and to some led deep programs efforts building the strong registration unmet combination as on build assets, and of this. soon address foundation drug the I very broad medical Held. clinical build strategy our we Tom our the way, high through to talented assets, for as success our capability going be very continue single-agent the is and five our obviously, in well foundational team Obviously, highly now will But BRAC and

in for think, testimony, truly U.S., Japan. kind States, United be ongoing common and medical this, looking will are collaborating with be the targeting unmet patients. what we're And meaningful this for difference really So, if Europe, I we're looking But us, you're anything if centers And science needs. for journey. we're how investigators, doing theme, academic of high can this

external I experts molecules think on what sense of science it's have. kind and also reflections this common

crowded XX Obviously, portfolio, the tremendous but said, beginning next unmet registration everyone, So at we've assets. Development. there's in PIXK-delta for advanced across needs on it's journey medical still our faith for it's be high extremely lymphoma has very development to encouraging. couple we're very to itself. progress our of within definitely with distinguish of but complex market, But are and least Wei-guo very of Obviously the International as and a encouraged. our world in worked will profile made But XX the months

Great. Thanks, Marek.

is question Ethan from next Morgan Stanley. from Our Ding

hear you me? Can Hi.

Ethan. can yes, Hi,

thank year. ask perhaps. solid such two taking for questions our question a Hi, to Christian and on on you, like [indiscernible] hi, I congratulations would

kind total for some about Also expenses up ELUNATE provide surufatinib for these be price there's you question; some second and color and on What we both can in the savolitinib burn rough your cash XXXX? surufatinib year. reimbursement China? negotiation burn, just provide cash upcoming renegotiation. this us eligible you Could will first in could expect? and strategies of any. you. you competing remind I guidance drugs? will for products the cuts your both, pricing be First, for Thank Maybe savolitinib if compare with question. And That's could R&D about think

Thanks, Ethan. Okay, great.

level pricing But sensitive. similar very at of yes, launched surufatinib to is obviously So we obviously that we've at. that -- strategies, launched pricing a fruquintinib that

access pocket in year. get it's surufatinib with this US$X,XXX to paying out of surufatinib. authorities year, get program, on up patient the So means NRDL that who we'll obviously the work access tested important to are implementing early say on a And to balance regulatory next the now surufatinib the engaging to over high of patients we're be US$X,XXX, month, an enables to

And interesting fruquintinib NRDL. been on patients half we're second beginning can't approved that can try I because to than year to the accessible over the similar order NRDL we to to has during So in negotiate is to bit of engage into right. savolitinib really first on than levels detail to very get try at this the NRDL give savolitinib the other in will that spend, to XXXX, the a Savolitinib, we obviously have pricing that keen half say, fruquintinib of more go savolitinib and make we any in period then different, the or to of one, get discussions the get take.

get change years looking NRDL have the year, we a ago, in been would it's later. big XX So, get the a to middle months year, of the you're two approved on

moved the there's regulatory Chinese that the get on get chance middle a aggressively, if authorities in year, Now six approved so of you the in have months. to

So we're working Savo. on

should sort savolitinib TAGRISSO use pricing that public all for of that the by you is that global TAGRISSO, information. pricing probably was think strategy benchmark is on AstraZeneca and pricing I China executed

reference. I think wrong won't far looking go as you that at too a

short that's pricing. and Lilly drugs aggressively. Finally, of Lilly obviously going built we that we're renew of off position working on a we'll on and generally a be regulatory period wouldn't more have on changed the kind But hope on renegotiate the is discount because start renegotiation ELUNATE. has into the in such our to discuss I mean, reasonably fruquintinib, of Eli have relatively too team benefits franchises to the authorities think getting large for good time, reimbursement And ELUNATE be slow obviously be in one significant. now would discounts commercial that. ELUNATE, I I a wouldn't small that the the to we'll get very bigger are we a that with work of

that's as on -- really that's Ethan. as So much I can say that,

the R&D year? guide guide of you'd spending a the this Johnny, on R&D. like Well the give on spend. Maybe to amount the Sorry, R&D

okay. Yes,

likely but XXXX. spending to of I a we our spending R&D clear double appropriately, ramp-up haven't spending to in we'll think So guidance of out close given doing XXXX, on the R&D be

Yes, fair a that's assessment.

I up you're what are and to this million in so China. eight Wei-guo stepping just team many this going think is, year from -- studies materially you're to in XX $XXX the we see hard XXXX, up going registration to that see level of so China initiate working over saw to back because the to

imagine But of around development significant a multiple over will the double year. organization kicking that then easily back million Marek And could as could into last And as year, so steam the full well of $XX Organization this this is the And more. FRESCO-X year. pretty I the and burned step-up. that study International the potentially assets, expansion of be

numbers are kind of looking So we're at. the yes, those

from Our is Bank of Stranahan next Alec America. question

my Hey, thanks wanted to and XXXX. for offer taking in all guys, on congratulations questions my the also progress

hear views is benefit up year-over-year versus First from the from on ELUNATE, PD-Xs Chinese go-to-market outside how among guess what I biggest studies may in curious the various any and coming I'd on your NRDL tick has Savo I would greater transition ELUNATE efficiencies this combo you much Innovent for of from strategy the and the ELUNATE others play whether BeiGene, difference And you how made the your in see say be of China and the following you Suru, guess in this presence PD-Xs launch? inclusion the expanding then clear to increased given leaders of ultimately and think ongoing?

progress took on But PD-X and since difference commercial on Yes, Wei-guo maybe ELUNATE so Alec. the maybe to one the side, over. the what's that. we I'll first biggest ask the answer of answer Thanks, I'll on

While XXXX. kicked in for X, January the NRDL -- NRDL on ELUNATE the

those So ELUNATE. Lilly from And our quarters had to three presentation, the quarters end-market on reimbursement with as increase sales sales year, real difference would XX%, was over growth. before year mean for Eli see three the I last team I our you can QX, difference, in Then, coverage. increase, as terrific classify which took saw tepid. was and the fairly the relative we

ground XXX, in You year, aggressively. everywhere, XXX and on China people have across this very maybe people commercial we'll XXX XXX of go ELUNATE covering plus end from the marketing growing. By China to the

can other I get you that thing it the you you listings. to hospital the is that most does hospital think big benefit the get important, access the allows is on of for pharmacies. What's the to that getting NRDL

hard on in China. get very listed hospital to pharmacies If the you're it's the not NRDL, in

But on the pharmacies on you're sort hospitals. dependent proximity retail in is key. of of hospital pharmacies, So getting the the

the of relative before. what hospital listings in year, had over the XX% last quarter to so we last And gone increased on by

listings hopefully coverage of that year. better aggressive hospital activities, the about last year, into will and listing So XXX up and believe it end we this at team, having to a translating that over hospital bigger more double was

make will I that difference, a So big think.

on you you of differences fit see towards maybe playing with China the on and key broad comment and in PD-X the real those a how and we Wei-guo, So in China. relative both out getting listings. how focus outside could are landscape that hospital coverage,

you're terms and about about leader difference China or revenue PD-X or or the sure just on -- the clear not was market I'm in efficacy if in safety. the So talking of about question compound sales asking

the in But it's not working that I compare on head-to-head been PD-Xs reduce we're with conclusions, any I So don't comparisons working data Genor's to have the TYVYT, done different TUOYI, with different we've we've mean lot of a and we've any Obviously also different of but PD-Xs market that's comment terms with we PD-X combination to the -- agent, late-stage, working safety been ASCO. PD-X. be normal, can't quite CRC in relevant the profiles, with size. consistent stage also advanced make obviously fruquintinib Innovent only the same patient in with quite, the with in at PD-X may The thing efficacy, Genor's will single terms of published TYVYT, in in upcoming be profile. safety fruquintinib data the combination and population

driven point. comparison seeing and by at bottom terms or PD-X whether we're driven able data data in tell But to the this make But at it's that top-line So, is line be data hard ASCO. similar will of appear fruquintinib, be to be there it's some efficacy may available to you the by similar there.

and of in compounds, combination clear safety. available different and general terms and well. quite really we think a for about zoning PD-Xs VGFR with as VGFR PD-X of I and obviously take efficacy in of how have versus of But compounds China, synergy similar. are also in of instance us lot differentiated outside we data indications cabozantinib are evidence of in a I versus this particularly advantage already of or vandetanib clear It's for quite surufatinib regorafenib landscape PD-LX to So China, can difference in terms I VGFR think and think checkpoint in in anyway fruquintinib as we now said

forward combination very certain examine with will against II study building surufatinib of with. we'll move with seen combo, in have where our Pembro in and instance we instance fruquintinib we're and basket TUOYI, emerging the encouraging through So, we select a terms style large safety to data. profile, obviously, database efficacy for indications And Phase combination for in really fruquintinib quite and TYVYT

we're mentioned, encouraged, and to, a we the wait Basket as some we'll I China So we're well. need Phase move that emerging forward world basically, be with of data study for the bit indications outside to quite and encouraging we're optimistic in that to really the very can mature quite II, these seeing as will very early is both and in the data with And data. the a

Sorry, I can't comment on Whampoa.

BeiGene signals collaboration across there cohorts, and Wei-guo, is just to multiple development from large U.S. BeiGene we with that's partnerships this will know development slide, building with actually have to you has collaboration, found Christian across in and PD-X the on combination leading surufatinib be tislelizumab multiple potential in you across so and international as very going have late-stage presence, starting which are shown specific answered be perspective. fruitful signal. we currently with also, the fruquintinib that the U.S. great obviously on active

Next question Goldman from is for Choi Sachs. Paul

very much, Christian. you Thank

XXXX. clinical strategy me in couple Let offer on and A also just my congratulations questions question. the all of maybe progress from one us then

the prior from dose Just your tislelizumab prior experience and II BeiGene remind recommended with us can any in Junshi that given reason the PD-X? work of the Phase surufatinib plus combination wouldn't there milligrams XXX you is be

I'm Wei-guo, but something. missing to to I Marek that comment. unless leave think Wei-guo be I'll don't that difference any Maybe should and

Yes, I can make comment. a

profiles I can don't mentioned, As in I safety quite different. but lot efficacy, a difference be of see terms

recommended and in are I mentioned II TYVYT fruquintinib with fruquintinib combination and Genor's the combination different. in fruquintinib For for also Phase PD-X with doses instance,

-- whether So

Sorry I'm asking on surufatinib?

know. I Yes,

don't know with So too be it be XXX assume it far may is tislelizumab whether from who far surufatinib XXX, XXX. I from But in will knows? combination I

this tell difficult to at quite it's point. So,

if be different For but between should that TYVYT it dose instance, combo. also you recommended is probably saw, I'm at that, soon ASCO the published PD-X we not regimen fairly sure Genor's and fruquintinib combo published

of any think not. the the very tox mechanism action, or in different as small profile, similar, overlap different. say molecule I PD-Xs, on efficacy of depending And this quite I whether but be safety a was terms can So profile there's

So be it can conceivable, be, quite actually. I can different it think it's quite

we the question we'll the in studies. our which safe also delivery simplified of phase, ongoing as have exactly will this answer standard escalation Paul, part And answer design, quickly this very you

mg maybe that with to trout, dose thank then used trial on regard you the can of XXX feedback population? you that dose would And or think registrational be the last year at okay. study? guidance ASH And Great, also USFDA sort Very XX the you the identified you helpful, provide from the preliminary you. do any that received for

with Maybe I'll question I regarding well, think let let saying, Paul. U.S. what our strategies -- the -- I'll that is you're

Yes.

Marek, can ahead. go maybe you So

you, Thank you. Paul. Thank

Christian So the just preparing clarify, says to USFDA. we’re discussions with

So stages as the of escalation. today, we're obviously still in final of

U.S. While we phase in a phase. see obviously very of of the study, activity this encouraging to encouraging lead profile, conclusion that including escalation we'll very

quite population Study from China U.S. as discussion Christian USFDA. emerging that our described, us of will our large lead with and to data Now,

see phase. year. the very our So we in it's by of well and still second signals to be we’re as part Study this as completed But U.S. encouraged in China the escalation

data as in generated or elsewhere, China definitely pre-NDA we've said, data approach setting. and As bring and the discussion well. past U.S. high that practice totally in transparent innovation, in build you as, the at as done We'll similar regulatory with as surufatinib through open this know, open our we'll and considering unmet for on medical long discussions looking take is clinical needs obviously this I've USFDA, of

So stay tuned this. on

Marek. Thanks,

Okay. Thank you.

to good. your so part, Paul, second To correct of data. now at far, your nearing hang milligrams similar was, part those so question completion We're and China escalation we're published right on we expect second of do XX

range, method. speculate, in months will be you're growth to on which a if I less, still be me so, expect cohorts not the depending of complete within will And we or milligram similar asking observation a approaching DBLP XX couple

those likely think. So I expect highly be that will to

Okay. you're your balancing regard about thinking to across is And out your capital Thank in that when your building the oncology this, programs, strategy And which allocation question self-sustaining? mind you. footprints. Christian, business does become with how then clinical one does commercial

both the Thanks, Paul. right we're outside aggressively we're China. inside as PD-X whether the being value the indications into our very to aggressively, not We're maximize that and Obviously, but combo, moving moving or as can I everything it concept being a data just registration mean studies. Yes, mode of realize of that assets, et we we're be where that's XXX, compelling. now, in on developed we're moving proof of is cetera XXX, choiceful

of And the probably this manageable said over company as earlier, as double R&D side this at as on year, last relative we the year. So, burn stage. a it'll far level that's the that burn, is to for

resource at So I'm constrained not this point.

team. seeing side, the from terrific commercial On commercial just our execution I'm China such

point I returns. think not we're anywhere near of a diminishing

building this team only deliver So, year XXX, from by our the of up in to a to concept going to is of the material end XXX incremental the value company.

I So, so of eye this company in listing. this a where our and I've listing, of Asian standpoint, potential a mentioned we on keep phase a the markets. capital Kong think accelerating, observe we're to in Shanghai continue close markets from context a we that in evaluate capital think we're or equity I need Hong announcement of the evolution strategic to equity

we'll that to in for from think XX really as I in time hard be have the we create position a that for company XX the we we're material. as think value months. during to the I everything good a resources And So next can financial push the certainly standpoint, will

So hopefully that your question. answers

Newman, John Next question Canaccord is Genuity.

Hi, the for and Thanks congrats XXXX. on taking team. also, progress in my question

on working clock you be which excellent. going think is the in around lot must guys a your whole I sleep

had Just questions. two

were been expect And optimal if is reasonably NDA the the might The first NET had in an then to the it second very you always at III proceeding as would that study to FDA? just an question and me accelerated confident if you're just that And XXXX. the with like ask AstraZeneca. update I give that? that SAVANNAH the you with excuse what wanted is the us that be could approval. U.S. Thanks. on could filing, dose about about you sounded in how which with emerge Just Christian, one curious is I Phase doing excited I've is, the with submission surufatinib

in and first to cetera. it hand do I'll review then the NET going about Thanks, I'll priority John. talk Marek SAVANNAH the U.S. the NDA and et over how to is

we're beefing up the milligrams milligram TAGRISSO our milligrams XX the BID, data. run XXX XXX study a a study. as milligram So SAVANNAH, enrolling of lot -- QD. with the great dose completed the of enrolled as said XXX global We is yes, combo earlier, QD And really on study. It's as patients. in well -- now I It's we've that XXX a just enrollment QD well

early confident treatment strategy, the it off view line clear AstraZeneca all playing going it third failure, TAGRISSO first of a I'm relevant well of just takes is good just everybody, well we're it be to -- well. going we'll the so in by we'll the regimen biomarker line come second but out, -- off time. playing I And, dose that's the a most failure, the dosing QX the TAGRISSO be think And position. ahead and that mid-year are out competition, and will we strategy, that as line and as We have of on strategy, is is to maybe is very the be

Maybe for talk to about the answers it question. rolling So, NDA hopefully that Marek submission to I'll Suru. U.S. hand

thank you. Sure,

is for we X a and in under Track submission, be We're NDA completing April. wave, we Therefore, with should end end first likely intensity December submission X of rolling afforded So, of designation. submitted Wave Fast high submission and mode. our by

we're endpoint requiring complementary and accelerated strategy based Just on the approval, which to the clarify, then not our be surrogate -- would standard. is not

full We approval strategy. are within

modules. of would happen So, validation of last after completion which design to of submission up obviously, FDA period be review, will type it to wave submission, within

validate letter XX review. the has type So assigning of send days FDA you a to and

the on seen or questioning open based normal to decision. time. review priority be this obviously, So It's honestly, will be review FDA

our progressing So we're is but hard, very team very excited, working on how it's track. it's working,

feel time it. about know, that you good it's As we

Next Tony question Ren, is CLSA.

thank taking congratulations Hey, for question, the progress. yes, my on you and again, solid

Just the me. from two quick ones

first clarification, take you in can this XXXX. one perhaps just Christian, The R&D one the expenditure is a about

I international right think going double. to I million you heard said is $XX portion the the

XXXX? is so a about question. second obviously, the $XXX double you million, your do the study. too sense SAVANNAH So well of Thanks. that we How Savo, in in you it the GU; from didn't as had also But the guys That's at ASCO two XXXX study good question then portion, which is guys going to first And the China is well. from make that's in had do SWAG PRCC, the these studies? results readout

Tony. Okay, questions. sure. Good Thanks,

So on double. could the R&D spend, double, yes, I U.S. think if not more than

from wasn't MET I a study I be million likely more it'll selected That's biomarker in believe the The biomarker, somebody the double MET XXXX; a outcome right. mentioned from the may investment sunitinib, don't savolitinib think GU, that study it'll, think right, R&D. increase. XX% that ASCO study. on was you else Pap China that Zubrod, $XXX Pap but study But study, and Cabozantinib, I

was So PRCC patients. all basically that

a do give as inhibitor not the And patient you of know, take. MET So a XX%, is cell or in MET positive. that patients we papillary proportion carcinoma, in don't that is to expect roughly renal well are MET-driven

years in there of field a been inhibitor. to But in cell in with broader MET that are imagine, VGFR VGFR would XX% renal to standard still would would patient cell and do so the inhibitors respond But were clear So selected in never a PRCC do savolitinib. you relative you to combination if superior of PRCC retrospective carcinoma, expect biomarker MET PD-Xs. a the better the to cell no the biomarkers example, you you for on analysis treatment. on for they've that in study for Cabozantinib, are patients And, care to study, do and obviously going renal positive many would the inhibitors than doubt of carcinoma, be in expect savolitinib the the case this identify population I patients, that had

Deutsche is question Rajan last Sharma from And Bank. our

kind your cell in I fits three J&J’s savolitinib context of how and question. on dynamic space, on and for Savo you kind it just within was Hi, perhaps see non-small the the Thanks that and lung competitive it in and to potentially just thanks. cell that of the given could of and your into perspective recent [indiscernible] how potential now? trials hoping space, particularly kind impact the compares us Bispecific lung ability kind in developments give EGFR negative recruit cancer cancer whether non-small also of any future asset you

answer Sure. Maybe question. to Wei-guo ask I'll that

Yes.

first lung So J&J’s line, basically in the Bispecific, cell cancer. now they're non-small

the will we think don't for only the directly MET not them, also not first they're selecting but line, I status. so really with in compete And

and strategy. be we'll driven biomarker So with clear very patient really selection a

the don't first-line competition, who they in very So a same of be in I convenience, competition, in we very different think patients, trial population, and about terms we're also in terms to patient but clinical future, will market products, offer for of we're good talking think terms years think enrollment well. of advantage I the oral we as would And obviously oral, live, IV. have are we're and compliance in when

many, talked skeptical we So that's And EGFR in of lot a There are to first-line KOLs China. China. for patients And them were lot our quite obviously lung IV some belief. many cell of actually about mutant, of in the a non-small products cancer years.

in started same in So -- obviously, boat Phase getting at point, one. this all the III. just We're efficacy is number getting

delivered. we'll I and to remedies see So these how be both will population efficacious, down in it terms treatments patient of if think then are comes efficacy,

that answer question? your Does Okay.

Yes, yes, it's helpful. Thanks.

Great. Thanks, Rajan.

Q&A Christian wrap and end of pass up the Thank for to the I'll the and now the the up. audio and the for one the still web. the is this session on queue you. time And apologies And management who

everybody Well, to a for the thanks the it join taking off very today. just Okay. on very much, time to positive call note. Yes, finish

the will Marek important just be company. continue as for can as you year I really progress, hear to a great and Wei-guo XXXX from as think think I presentation. making We're well the

much thank goes by. as year dialogue And to of look kind you the we all very forward So support. your for continued

it'll be lot I will a about. think one where have talk we to

much take and very care. everybody thanks So

This conference. is of end the the

may disconnect now. Goodbye. You