Zai Lab Limited (ZLAB) 10 May 232023 Q1 Earnings call transcript

Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab First Quarter 2023 Financial Results Conference Call. [Operator Instructions] As a reminder, today's call is being recorded.

It is now my pleasure to turn the floor over to Billy Cho, Chief Financial Officer of Zai Lab, who will make introductory comments.

Thank you, operator. and evening, good morning, welcome, everyone. Good update. recently of the Lab well some and issued financial a details the as corporate highlights product providing release recent company's as press results, Zai first XXXX quarter of The press release website available in ir.zailaboratory.com. the Relations the at company's Investor is section

Head Lab’s oncology Chief Amado, will Today's discuss by be be product Zai Josh Diseases Dr. results. Global Operating Global will Officer Reinhart, performance Rafael products Executive of market the areas. in Smiley, Samantha the by and Infectious Development, progress will about Chief and and Head with and therapeutic we’ve Develop made of on and Officer. Oncology joined President Dr. financial discuss call will our candidates; of quarter Dr. Du, our conclude our President Research Harald first speak those led Founder, and Development Chairperson. She and and will Neuroscience, comments I Autoimmune three President And advances

will Additional portion be the call. Q&A questions of the during executives to answer available

and respect sales filings. As product our of of those guarantees actual These call, our to candidates, you in materially therefore Act and will factors, variety and are forward-looking what commercial certain of differ should undue making performance and and statements SEC subject are Litigation discussed expect meaning launches. Zai including statements them. from future to and reliance Private within a could including due our put and the XXXX, forward-looking revenue upon with not today's forecasts numerous a Such results we be uncertainties statements of not plans Reform trials, Lab business the during objectives, products reminder, clinical Securities to for regulatory applications risks

to Founder, Zai At this Du. over Executive pleasure and Chairperson, the time, turn Chief Dr. Lab's Officer is my call to Samantha it

you Hello Billy. everyone. Thank us all joining you for Thank today.

track trial record potential Zai line positive EMERGENT-X from challenges top of beginning quarter China’s and readout best-in-class continue execution, the to The re-opening X global and the portfolio progress Our year. demonstrate at despite from results further Lab’s products of X analysis first the of cancer belief Phase patients KarXT study innova head support that neck in schizophrenia the globally. the important from from in our Phase TIVDAK treatment and options these TV positive and provide in China for XXX and

are U.S. Food Drug caused Administration We severe recommendation infections of the Committee’s therapy of with life-threatening patients the Advisory pathogen-targeted in by very excited the sulbactam-durlobactam, and of unanimous approval first support for Acinetobacter. by and

oncology and cancer on focus with program, develop lung our a we pipeline program demonstrates DLLX conjugate next the space results antibody-drug global complements leverage global extension seeing our and to our Recently, global to ZL-XXXX. we patients. expanded the continued in generation enriched our ADC franchise This ADC ADC our ZL-XXXX, lung strong market. and to capabilities product cancer franchise, will our forward look and or This

next goals and and Smiley on vision to and in strategic further leading that corporate forward the and its and stage Zai operational To promoted China Operating needs and to for this of us business our strategic look beyond. rich grow President productivity, Chief transformational mission innovation growth, help we of biopharmaceutical as me and of global human we health Josh’s Josh improve stage I support happy driving to better leading opportunities. Officer. will next help have experience company a on and to our during growth, are global deliver announce meet into strategic our

to Josh. now I over the call would Josh? like turn to

years for to our pharma and what us excited you company I’m bio in move few I role innovation. the Zai is very in that work Samantha Thank Lab about to leader the look of taking rest to forward. next be our continue positions a Samantha. forward for to store this new team on company for and the with

pleased the with year innovative Zai in this unmet therapies companies Lab China that like for overall medical environment needs. with We’re meet significant

mentioned, to taken future for commercial Lab reopening the first good has quarter, our in Zai results. Zai steps the Lab financial growth by As strong from Samantha of established solid performance. and a a proactive team, of China months COVID-XX overall during execution as financial challenges result foundation and the two Despite the continues deliver

year. period to last the and non-operating the continue in net XX% attributable of quarter to to And increased remains the first in ZEJULA ovarian this the become ovarian loss cancer for its ZEJULA class decreased income. the cancer throughout in asset we strong increase to with and remainder growth this product year, starting perform continues Our in sales momentum on compared revenue track XXXX believe primarily for year. China well same to of expect we leader

expanding market For by team insurance access Optune, our insurance to commercial continued improve and coverage. supplemental

supplemental provincial in XX of up and Drug XXXX. pleased As XXXX, from have XXXX. was Reimbursement XX, XX, by March March of to insurance XX to added covered QINLOCK March effective as List, NUZYRA municipal We're National plans, or China's Optune

earlier, of products their revenue a inclusion. expect we as strong discussed NRDL result a As ramp-up these for

the the efgartigimod, with year. potential. commercial launch getting product and FcRn U.S We're For and ready first blocker only later pipeline approved a for this

have efgar at launch. plan and with communicated experienced to specialized for earlier, approximately we XXX As employees team we

in potential its China. about excited are We

the progress With for our for the for to the made efgartigimod gravis, in gMG and strategic China. gMG of subcutaneous myasthenia priorities, generalized XXXX we've approval BLA towards BLA submission or efgartigimod respect

for ZL-XXXX, Trust Life. Greater data Phase LUNAR The our global call KarXT in cancer global with our XXXX in schizophrenia a our which details X into released CCRX, of lung initiation pipeline We're We Phase three cancer. proprietary has recently a global a including It readout by our commitments. advancing ESG X also IL-XX field's rights, of report moving of strategy, and the in Humabody, ZL-XXXX, full for China, gastric initiating full Bemarituzumab development. and study the for or study study and ESG that initiation non-small-cell study we for in tumor-treating a Greater China, bridging first-line registrational

health. First, improve human

standards Second, profitability with create We're to and better major And commonly commercial additional eight we our We're the end launch right preparing existing reach against million by patients by products to and X accepted steps indexes. overall achieve patients ourselves XXXX take act more corporate continuing outcomes. XXXX. are as products third, now. reach the to benchmarking of and

And call Rafael? now will the Amado. turn to I over Dr.

platinum-resistant progress primary met point, and Thank end year. NovoCure, statistically abstract improvement lung LUNAR Tuesday, added the meaningful the we in our XXXX, alone late-breaking cancer. that therapies compared morning as first announced data recently announced X, fronts, a to In you, lung DT franchise be partner, to Recall Lab’s We cancer this field overall clinically when Zai of and of June a survival the a make Josh. expect year, therapies metastatic, all patients will significant to presented to the cell therapy continue demonstrating that non-small with productive standard in have oncology in earlier on that its LUNAR clinical was on ASCO’s non-small-cell trial standard quarter session.

to XX% worldwide, and to presentation patients lung excited incidence cancer In results as have XXX,XXX the accounts cancers deaths the over out. We are types, for LUNAR are unmet needs such it [Ph] with forward for patients look and of study. China, lung cancer, to as as We due ASCO year. data contributed potential lung at each well be other read the tumor the PPCO year, part about the diagnosed is new of global cancer well enormous XX% or non-small-cell per and of to address of for cancer non-small-cell with non-small-cell subsequent of lung all pleased

mentioned, and the efficacy innovaTV study AACR neck the with cancer at our Samantha XXXX results annual April, in in head meeting. Seagen presented in XXX partner TIVDAK As treatment-refractory patients encouraging Phase from X

the responses. generally complete and cutoff data overall TIVDAK At rate consistent with XX% across response observed was with monotherapy was The clinical that partial safety confirmed X studies. response X profile

Treatments for neck approximately new annually. head unmet in remain cancer with cancers a XX,XXX China, need significant and

low progression chemotherapy limited response therapy, are rates standard Immunotherapy with treatment there on and options. outcomes. first-line Following poor have objective

and this collaboration indication we in on Seagen. TIVDAK with are recurrent planning to to data option metastatic China with could are head believe patients cancer, we this more be result, for and neck or promising a While required in treatment pursue expand and

on solid subsequently the communication tumor, other Moving or partner presented Phase data KRASGXXC Journal Mirati X and patients updated the results in brain, our April in KRYSTAL-Xstudy and with rapid cancer, as at now the adagrasib, program to heart, of of the Oncology. KRASGXXC of ASCO, the a published tract biliary series mutations Clinical adenocarcinoma, pancreatic plenary session

a solid cancers, These these in and objective results improvement few KRASGXXC treatment adagrasib a it reported previously and the with of non-small meaningful Notably, safety In overall the for to objective with lung cancer. pancreatic biliary was historically XX%. XX%, rate with pretreated that Results an the adagrasib cancer, rate demonstrate showed cancer, cell of patients XX% improvement colorectal was the and standard-of-care for reported patients cancer response response tract aligned was relative with profile patients findings cohort. potential Mirati to to metastatic the on current harboring KRASGXXC see closely with study, a with options pleased Phase as unreceptible this where of tumors, for advance working We treatment are including mutated option mutations. to standard-of-care patients best-in-class marked gastrointestinal for we for cancers, or exist. tumors with the very which demonstrate X forward look patients

data programs, to development from new AACR, monotherapy translational Global internal that well Oncology and our a as Program, ZL-XXXX clinical global anti-tumor to of signs we showing articulated our specific showed be activity. Moving tolerated pinpoint and and biomarker early and ZL-XXXX, presented antibody at to research seemed

expanding or our internal ADC external building and phase In ADCs antibody pipeline discovery through both potential drug conjugate addition the of and into first we're TIFGAC, a to and collaboration. portfolio best-in-class or

and an platform.. in increased using is designed we platform the program, current a next-generation MediLink's overcome to challenges our proprietary to ADC leverage DLLXADC enriched microenvironment lung TAMLIN compound ZL-XXXX. tumor franchise innovative Oncology TAMLIN Global a month, This ADC ADC is next-generation Last the with our discovered drugs. cancer Pipeline by

cell tumors. overexpressed and DLLX of inhibitor lung Notch neuroendocrine is small that ligand cancer the is an in

capabilities advance clinical leverage global our will development We product into to this studies.

about year, track the very our bemarituzumab this best-in-class cancer milestones on Repotrectinib gastric the of excited cancer mutated of non-small We are an are oncology in all filing in at globally, and expanding initiation trial of products, for abundance to pipeline and lab. Zai with the the both potentially and first-in-class including China cell China we meet lung ROSX

progress our over And now therapeutic areas. autoimmune, Reinhart and I discuss Dr. disease, Harald neuroscience floor Harald? infectious the to turn to will the in

I'm Rafael. Thank with opportunity you you, areas. to therapeutic for excited our neuroscience across and share progress infectious diseases, autoimmune, the today

its with developing in released primary were endpoint, third Karuna March and placebo trospium, X. are met schizophrenia. positive reduction KarXT, points the to the of start trial in Let's demonstrating acute This with EMERGENT-X KarXT of PANSS XXXX. we our in X.X now trial compared a total with Karuna’s partner that at Results which combination xanomeline registration from has is week score

demonstrated symptoms drug application the secondary reductions PANSS of PANSS third subscales, positive, trial. negative in to in half in measured which of a as in the KarXT PANSS new of schizophrenia by XXXX, negative also and submit second the plans are negative, factor with the Karuna XXXX quarter approved. positive and to FDA endpoints launch if

be very could of as KarXT for a and treatment mentioned, a medicine Samantha China new in class schizophrenia option globally. important patients As

are plan clinical development China trial on bridging by accepted we the and proposed for a June. track start has to in NMPA, Our been

our in favor approval of Advisory voted unanimously FDA portfolio, the diseases or Committee Sulbactam-Durlobactam Regarding of recently SUL-DUR. infectious

this submitted committee's the was officially Infection one an Carbapenem-Resistant priority February, the We NDA strong this in longer quarter resistance. drug bringing NMPA infections Asia-Pacific, excited to XXXX, was and in confidence. And We NDA China VYVGART efgatigamot. can accepted in with made NMPA. about progress December We be for the of frequent to by adequately because novel Acinetobacter look Much of crab month or the are vote granted no review where treated to later. are often severe forward to and treatment the multidrug of past

approval and BLA treatment or year. China quarter patients GMG, of the generalized and myasthenia We of submitted gravis, commercial with in launch for in efgatigamot this the for expect XXXX IV the second

subq mid-XXXX. in GMG We for a also expect efgatigamot to for SC submit BLA

We and GenX worldwide. continue partner to in support on indication our expansion China

moving forward not but are least, and trial. we preclinical for internally Last developed preparation regulatory activities Phase IL-XX X in our topical our with global for product CL-XXXX,

who results. Billy, about financial and hand speak progress our now me over commercial with Let products Billy? to will

Thank you, Harald.

$X.X year-over-year period. period million growth. compared will $XX.X to and quarter million to XXXX This representing same in million same Total of results $XX.X of XX% I compared first representing product year. $XX.X in for for to for same for the same quarter same the our the product were of for compared XXXX million $X.X revenue Optune, NUZYRA, the representing. financial million for to revenues last net $XX.X period $X.X XXXX, XXXX, QINLOCK, for for in million XX.X% a prior discuss XXXX year the period compared $XX.X first Now million first the growth; $X to included period period $XX.X for quarter the in of million net million compared year-over-year million ZEJULA, to XXXX, the for compared XXXX; for a

for distributors previously new in products the their to are Note initial with revenue in purchased selling of non-recurring Such compensate connection million of inclusion at distributors NRDL to quarter prices a $X.X in in that to product to our QINLOCK price. industry reductions those NRDL. on NUZYRA made first compensate included and customary the XXXX rebates the the sales prior distributors price adjustment sales for negative

expenses of expenses period our in payroll-related XXXX, Research to headcount. million first to same and increased and trials, last the higher partly decrease due R&D partners clinical by for $XX.X Development primarily quarter was offset collaboration million the cost-sharing year. R&D payroll The expenses were related compensation to compared from for from $XX.X

same headcount. first was Greater SG&A and expenses the fees million increase to our of $XX and in of $XX.X the compared The payroll payroll-related in commercial to and were for service sales increased products quarter due in professional higher XXXX, higher million XXXX. for with connection primarily with expenses China period

of to infrastructure net or of to attributable operations in China net for period United Zai growth The revenue in of $X.XX expand XXXX, years. net $XX.X its over decrease the anticipation in expenses, million, interest commercial loss first invest to and in or As the $X.XX. to growing share share in including for a than loss in States XXXX, faster and foreign to Lab attributable loss currency of Zai substantial Lab product common the stockholders next million increase loss was few the of reported and to loss quarter the compared per continued a stockholders a $XX.X a of due in operational and same income, common non-operating gains. primarily per income

equivalent, the to operator As the now to short-term of $X restricted XX, March XXXX, cash questions. back to December totaled over We would as like for cash investments, billion to XXXX. and compared million, and of line turn call $XXX.X up cash the Operator? XX, open

Our Instructions] Thank question the you. from from ask of your Michael Yee line Please comes [Operator Jefferies. question, Michael.

you the our that should timelines had Can Thanks. quick know approval? Good expectations two that with NRDL, are guys approval. on for ramifications questions. XXXX that, morning what expectations us would that the On would work be and for what NRDL for and question. for we our are in and timing how and timing your expected give and for I your for getting be update you waiting of efgartigimod, That an first

there obviously, TTF on coming data the up lung cancer a at is, lot second question the ASCO. is focus And of

in China? Can understand data relates ramifications you as of us remarks. combination the of in your be the docetaxel, important expect and PD-X line the it to result prepared particularly that for how that not of for mentioned Thank but that with China, use the you. to help PD-X You you second and strength

am I going It from is questions to hear Josh. to Good you. executives Hi, this our morning. the Michael. to direct

we that not looking efgartigimod or that, can to discussions there forward start approval. date in have mentioned. little What a question about quickly will China potential know, will well, On going and we the we to an over in move is have are on LUNAR. for I to moving We and sales need and as my updated So, reviews fit about say I you you opportunity. promote have go can Once then are regulators we for ready then reps address but are be on toward approvals. packages you window, through. as maybe going comments, product, me, strategies efgartigimod, PDUFA we your with In to, continue XXX directed to and summer launch NRDL. well, the developing we a planned bit approval as sometime they at excited about the talk we will could into is Everything prepared to again, LUNAR, Rafael to a please. and we are quickly I keep we that the think, are to Rafael, launch, we is

Michael. Hi, Sure.

the the implications is, patients the is the IO first patients with patient line, data received answer for line, therefore, the front received checkpoint resistant tend the applicable line, EGFR data inhibitors so checkpoints to may meaningful clinically actually particularly patients to much if China. they so get front a addition of in have receives I in with times, significant, that checkpoint it about second Clearly, this study, there So, applicability and with question benefit, and most every is line? not this inhibitors that of is is and add mutations, have that don't the that some in think in second-line Often is it mutations mutations. there.

front-line in synergy which able some really think, to study think and of study, be There's this I a between corroborate also field a and we evidence, keynote will demonstrated BXX. I inhibitors, checkpoint is PT which in the is the

believe establish, agents evolving, cell that in will really really think treating synergy cancer in. new of come and is that in as I patients observing is entrants standard-of-care you the ways would as new non-small we there and different LUNAR, and this that study know, lung be

this data based this on think of PT there set of will with be the excited we that patients pattern pretty really are definitely on China, this in the that I benefit will share and from and particularly combination. treatment shows ICIs So enthusiasm synergy NovoCure fields, and

Thank you.

Just we a be to for for get that acknowledge hit Josh, NRDL. by to there's clear approval we need summer that want that to we do deadline and correct? That's

approval Yes, to we – the summer, are approval get don't going I would at quickly reviews updated. it, we Yes, for as we an we're well. I XXXX are again, know so as think need as over well, have like possible keep and but be we say, sure, mean, a would to I until negotiation, and for we'll going eligible everybody things

it. Got Thank guys. you,

please. question, next Operator,

Thank you.

the from Citi comes Our question, next Nochomovitz your from of Yigal Please Yigal. question line ask Group.

thank Yes, hi. Oh, you.

just the Phase timelines could Bema, For X the gastric? read when for you first-line what could out, and and trial view about drug the running talk China? on that When launch in that can current is

two X And joining Xs, mentioned you first-line trials, press just FORTITUDE-XXX. in the also then FORTITUDE-XXX and the that those you're in both global differences you gastric? release between Phase please, Can explain

Sure, question. for yes. the Thanks

I you. both are think, these Rafael, for

cancer, Yes, that part There treated. so it start of are to standard-of-care, are the I'll most patients TIVO with That really way the is question, the studies plus and two gastric a PD-X inhibitor, Yigal. pembrolizumab. tends in be either XXX the second or

XELOX, sometimes been variation that PD-X have because this really not started studies of used. about. as Some such have came used There chemotherapy, these is before results

So that's two with with PD-X. plus XXX other uses uses it One, why studies. we and pembrolizumab the have chemotherapy pembrolizumab,

Amgen ourselves, getting started. but it process We're in we one in trial. that second decision The of participate made to hasn't the and on obviously have going the both

ready biggest actually. be study of having is is that been and imminently, discussion with be There's to approval China. We're Amgen. start, the enter we of level and on-going will which first shortly but study is and followed etcetera, FGFRX do will chemotherapy the So trial some just alpha, in the after, issues, expression will study, alone, that by a the with diagnostic, from it normal about to automating

have filing regards its will XXXX. we'll in, timelines, with a So study this course, follow sometime in to and

Okay, great. Thank much. very, very you

question, from Thank comes the your Anupam you. Well, Anupam. our of from Rama next question line Please JPMorgan. ask

potential they're give what in or at focused more expect Hi, a a one pipeline Anupam. for just to on more if on preview on us and dynamics be it going for Can this of commercial the [Ph] pipeline is is Day, products China? you We or the development-focused, question. have and to Thanks. Investor Priyanka

start, time particularly But quite thought Hi, that we Investor Billy, I'll there. this Priyanka. Day time ASCO it, an not have jump It's the Josh. in-person and we'll some out coming in. and to then, do for updates good some and please of was had a of have

our on we the as earlier on coming, certainly the developments. that eight our focus and will on strategy pipeline, look well discovery of into launches are as So a global some

outlook investors the please our firm. add, insight think dynamics a talk is sometime give will and for little are term coming into Billy, pipeline things if have here goal I primary deeper you do. the anything We about to our bit for But the of medium and that really, commercial to the breadth soon. depth and

this No, We'll and phase that by, some our a date was side the sending Josh. be all followed around to out sell well of investors month, sometime of details covered, agenda. probably more

So stay tuned.

much. so Thanks

Great. Thank you.

Our from line Jonathan. ahead, of from the Jonathan next Please comes Chang SVB question Securities. go

Josh Hi, and and congrats to my guys. questions Thanks taking Christine. for

First of and broad context stage and in expanding you as meaningful for question, beyond? do of company in assets, the see pipeline and most drivers clinical XXXX the the growth what commercial a

And DLLX And Thank discuss itself a timelines my with on pursuing construct program? the T-cell ZL-XXXX, thoughts us about question, bispecific tell associated with and your you more you. ADC versus the second can the engager. an

Thanks the Thank for congratulations. Great. you, Jonathan.

talk I Samantha think the to ask make drivers, on growth to of DLLX. to turn a about in, then couple weigh Raphael comments, it I'll we'll and

ground on the I lot dynamics in actually And in And think quite efgartigimod. hit a led play should out the the a of very China. the there. that excited mentioned, as and learned, can launch, in of U.S. launch I from think success upcoming We've the launch, to U.S. we're I successful lot I well-prepared drivers, running hopefully, we're growth obviously, the about think, an to

new certainly, as to a growth forward So, we're that driver. looking

NUZYRA for that in continue drive good penetration, mentioned the to of we the place ZEJULA volume share expect, of first-line and market growth course, the drive continues to class, in remainder leader, to March, front, as would to setting. revenue particularly perform XXXX. good on well, up And, beginning grow a as in and will NRDL, we secure QINLOCK continue and and

I include as about that we've then, potential TTFields lung bit launches in next which XXXX, bemarituzumab, farther looking for the a KarXT. into talked as get then, period, cancer, bit that we get think And little we a adagrasib, to wave forward of could Repotrectinib. little out

a are drivers. of there So, lot growth

I the be think, again, know the comments have on products market ready this that with beyond. on XXXX for want execute year, it's four launch well other in to and don't make if we any you Cartagena. to Samantha, and I

pretty you Oh, have covered well.

Maybe Rafael we most talk with about deal to to go little can a our DLLX. recent

Jonathan. hi Yes,

is inhibitor were with of So ability the to this the the pretty linters impressed has benefit-risk is ADCs it and payload This pipeline. product and yes, really the and based activity tend And potency We high good dictate you our specificity as a of then of as and topoisomerase antibody target to on are know, better the clearance permeability. antibody, the we feedback DLLX. ADC this are And so clinical complement for payloads product. this have a the ZL-XXXX. and is and quite high

and not that ADCs as that very consequence other good a are preclinical tolerability stable covalent. in less opposed as linkers studies, saw we efficacy to So have

And to bound mitosuppression, very doses [Indiscernible] able remain a again toxicity rash, as in therefore, high and covalent are don't are and the is increase relatively the So etcetera. payload this microenvironment. actually here There we other PK the it linkers to such toxicity, to tumor be stable and actually level. releases allow, could a see with higher that a linker

and of they're seen and companies a because also these products, seemed moving more that many that that it was like other to also there. technologies ahead technology was with advanced because, out have superior that also So it ADC we've

But we So bi-specific chosen I'm cancer. such lung cell we IL-type refractory the stability linker potency CDXX activity to in of avoidance opted small the impressive own that's getting and have bi-specific, risk there. line or from trying with affect our higher biotechnology settings And difficult space we in the use potential They've Regeneron. it. a other and chose perhaps as here to past demonstrated because the actually the CRS the We could given second benefit of of have how and, an bi-specific, ADC. toxicity

And validated real need It's the neuroendocrine why been chose really tumors, well, which also an a we by has hasn't lot I then to data. medical opportunity in DLLX, think of to it's and a terms of area Amgen's there expand target is that's been a where progress.

collection ADC to IMD this, I product future. is this of really next move the our So think information to led that us in choose as into this near a

Got it. Thank you.

Thank you.

question next ask Our Please your comes Chen Sachs. from line Goldman from Ziyi of Ziyi. the question,

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to that So how how the progress of in assets. sure to could, peers the and prioritize potentially understand programs resources the competition make make the you key properly to ahead you trying programs, of of would going some allocate we're those you're

while trying one is Zai probably saw is, quick local to Lab the determine China? on regulatory When the plan management assets. what Particularly timeline we is licensing should on China? more we Is visibility ADC one filing updates filing any more is on expect also for in adagrasib the that on question partnering is adagrasib. first the considering time China there of are A players Second strategy? factors the specific that their in the this with

Thank have three been questions. strategies? that that into you. changing potentially to you does So Those more been are your You looking have my mean domestic collaborate? biotech company

start can maybe on questions could Billy, to the for and we'll you talk all Thanks allocation. about try three. adagrasib. cover Rafael resource

any some our business development about Rafael, comments, can maybe provide you then broader around You can And context Jonathan, development. strategy. business make

Billy. So I'll start with

the question. for thanks Ziyi, Hey

of, two think Zai at to I next about achieve a able or i.e., that be this So so lifecycle, that to we important and a we're we drug very whereby strategic what anticipated Lab's I corner point priorities, scale our have sure and would sort organization's clearly. the relevant think to over say, us, eight turned have years in going we we make half launches

growth same time. While, productivity of kind a of maintaining, at level and the

revenue that saw So quarterly see as and growing of you But expenses. snapshot income see therefore, such namely profile, actually if interest operating gain. in results improving you also than line the our currency from faster some foreign a where, items, that you non-operating would yes, items, is

expect on out. from to you that should And continue here

early and expect make expect to felt that better. the that and year hope of the on confidence we here overall year, XXXX. us profile profitability commercial time operating see year the and to, to gave So to end look this and public we profitability target to from commentary like And year a our target, financial after this out, we to on reach basis better by we it

this starting something out. that we're and see here we So was to that expected from on

course, be, comfortable financial we're going quarter to there's but you're felt picture. going we improving Now that quarterly, see some to quarter per very of year-over-year, action, to to, start going

includes, we making all execute including, priorities, we about. talked the that launches that sure on bakes our So in that of right, anticipated

you maybe could Raphael, cover, adagrasib.

Sure. Yes.

to previous as we cell small in about data that referred pretty on So in cancer, data call lung to excited in the we earnings alluded colorectal, and second pancreatic well The obviously adagrasib. the at I line the which tract. data are as biliary today

across, with tumors is this solid GXXC performing exceedingly is So well.

get approved to this possible, as eager obviously. very product are soon as we So

frontline trials. will in number study we cancer in line also we're we And And participate on lung as and is the on cancer, the study KXX, participating second We feasible against docetaxel. are the are of colorectal which well. a in

are But because getting KXX. of of something the filing. can approval for of control accelerate the filing. always that in to CDE, can't end but not we control the we looking PFS be we data XXXX. really based ways on timelines, the can, we Obviously, was And with would accelerate filing Our working whether PDUFA or towards lack from

And And will Obviously, it have tuned products try earlier. follow-up won't make domestic approved these products so they So right of early. base that's Chinese [Ph]. all they I'll Allograft hopefully, KXX. they now, whether to have and we obviously some just can are, have But don't a or breakthrough are stay data of of the they whether sooner. XXXX. KXX have lot Chinese file we the lot have there see an from That's patients in response one really comment very we're China. in to case. durability, leverage we'll apparently the survival. are over a and leverage we be advantage have will designation is case why [Indiscernible] to and They rate, that don't And But them of be end patients, promises, that, see eager

do believe behind we So we possible. competition, really as very that best are make field. try but we in our available as soon this will to this There's don't to

think I comment we any study, which did the to we required but don't filing, comment last BK the file And we again already make, actually. is I'll made the and last this time, finished for it

BK. we when so discuss to would timelines, Chinese And these from to more patients data, CDE go we at have

we'll granular about hopefully comment and DLLX. data, this can the a we helps. discussion. able perhaps be make think I as continue Stay tuned to more give hope Jonathan, you you I our So

on for BD you thank the strategy. the question Yes,

of it's to a First all, not our it I like in see strategy. evolution BD strategy. changing an as

coiled. strategy is think multi I our fact, BD In

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Thanks, Jonathan.

question, please. Next operator,

Certainly.

next ask Please comes from Guggenheim question Our the question. line Seamus Securities. of Fernandez your from

Thanks. Great. Thanks, everybody.

of questions. Just quick a couple

likely understand help So the the to capitalize the size really necessary just commercial overall presence for of be just launch on is us first, opportunity? kind what KarXT, market can to of on you

how better the of of patient you commercial utilization in approval/ sort about Can of we the trying of KarXT a just kind just us be how of remind sense versus is thinking post the generic country launch relative should get population, to sort undiagonised

second what that you it as potential net associated with is about the the in thinking coverage, area and to thinking to other just topical spend will psoriasis? an dynamics the with really in good that perhaps IL-XX or to slow of been the be question challenges that pursue opportunity how two relatively Thanks. topical new another and are to board that you relates are space. gross for then continue it you agents purely of reimbursement it, outside pursuing on agents so Those but HS has how efficacy for across come we are And is opportunity opportunities market the just on opportunity treatment psoriasis, about to this see agent have in

dive Josh. of topics. it’s a comment the make brief I’ll sort of really but both in on Harald want Thanks Seamus on to commercialization, I’ll

to psychiatric it X estimates opportunity actively, with or hospitals as in think equivalent that and our wings million psychiatric China atleast whom commercialization million are schizophrenia relates of major about KarXT taking of X patients are speaking care across settings. I in

generics in are of ISO I [Ph]. I today. talk range Harald I therapies in think China heavy well come the could excited a is well of so benefits terms presents view KarXT that why sales [Indiscernible] can launch the certainly reps But think think bit XXX can cover about then combined that from the who prevalent aren’t little somewhere treatments, may or beta are utilized other at our centers, the about Harald the you patients and probably in are current and – responding talk opportunity we or about

you. thank Yes

from First Corona this psychotics a is add it’s see great compound, on that either and as standalone. existing a different or we and the anti really existing KarXT to so schizophrenia as compliment a opportunity regimen treatments so

own. in the just that of trial We EX confirmation a efficacy we in The studies. EX. with and similar efficacy have seen lab EX see -- already that’s shown this The population in is kind clearly of the another efficacy was the this patient signal of

with and So low told effort schizophrenia there is the is market an meeting area think in by this of we’ve a activate as is to a China said the in previous in treatment that already schizophrenia I undiagnosed the in more country. government lot

this So we as a commercial opportunity. see great

blocker like and drugs Tapinarof regarding added about similar an part treatment options. or Recently, are the out second again uniqueness quite are is I roflumilast. of basically, to where disease. that the drug of the in already number for there psoriasis, which this topicals of use different mimetic, XXXX, IL-XX And most XXXX of works was a question active would a the your from class and of ours. And quite those to just bring Both

IV bring So success of best sub-q concept clinical proof the skin. And we currently treatment early penetration markers treatment in directly see clearly by we this as has treatment or of and achieve shown to study benefit. that the a way our what is to

So topical One well but are we see and have systemic situation. results have in overall documented. which, other they unique other a absorption, very they exist, yes, treatments ourselves issues, the as in

currently class are I drug psoriasis. However, they leading are addressed I not question. for the IL-XX mimetics your really hope that

Thank Harold. you,

please. question, Next

you. Thank

line next comes question Please of Credit Suisse. from question, Yang from Yang. ask Our the your Huang

everyone. you I taking ones. Thank my for have two Hi, questions. quick

progress. First quarter is commercialization first

also So we January. one of And are impacts pretty XX%. Look there month. considering strong. saw for year-over-year just product first COVID revenue And still effective increase some kind in by quarter, DL

the first the COVID of impact and two a in my year, commercial progress, quarters for kind accelerated is gain So expect momentum? remaining kind no question, there potentially of IDL we volume should question more given jobs should be the will of

question. That's first

Second question on KarXT. is

kind you office year. design initiate pretty more study So are the scale you color us and a going mentioned bridging of on the and you bridging for KarXT? Can potential give soon timeline to when the this the Thanks. study of

the for you Thank question, Samantha.

outlook of about going you are And sort things year talk that the the other cover other can can Harold, COVID commercial and impacts you If for first which one, is obviously, then KarXT. and on.

question. Huang for Thanks, the Sure.

do also, inclusion month. RDL experience the like And The we impact. first two months China, in COVID last an said, you

we forward, start going However, from March.

seen much the effect. lesser have We COVID

very our to We are about rest to year. goals for the optimistic deliver continue the of

you Harald, want Great. add. Thanks, to

rate which was with almost Yes, studies of clinical Corona. program identical design. imminent almost ramping conducted China, study out the that the the similar, to question It's were about It kind for there. about same dose start. Very actually KarXT emergent the has by to in start schedule is to you've a seen that

the was the the as to global same program. design, in will mimic way try details seen it So duration, the we in the

to timelines, overall. us study, trial the was We the finished allows that start. study think clinical as track, our piece. is feel as I on some And also far just this which about your question, I said, As missed about to which PK was I unless confident

Thank you.

do we that when we study? So finish can expect project that

This point no is study time will understanding it long the this a in how There a clear new with at in long first drug. time take. is

So up. We lined we have have we the certain think centers expectations.

So be expeditiously. I will we think future done to this conference clarity a call for rather on. But do believe be this more get can

you. Thank great. Okay,

you. Thank

Liang your the comes next Our from of ask Bernstein. question, Rebecca from line Rebecca. Please question

Hi, question. thanks for my taking

that covered a even And net other we lot But still the one, by the QX. adjust NRDL, on after of growth products specifically growth. in there's a decline. rebate, for So we million negative the NUZYRA had saw already two are that QINLOCK, $X.X had

understand expect could you what's release to And when volume Thank better take do place? the with you me going you. help QINLOCK? on effect actually from NRDL So

added March Josh, It’s two Rebecca. just products effective Thanks, Xst. those were everybody to remind that

good making that listing. local a We're you're progress terms of to seeing NRDL effect real of hospitals. in So the the through really not in pulling QX,

the next So you to sales should and QINLOCK three see net volume quarters. expect good over growth

of to you. related marketing As quarter seeing you'll that both But from Again, will sales saw all products, – than I Samantha NUZYRA Thank efforts. in QINLOCK. COVID. beginning China-based volumes bit confident we're of challenges different and in our little think across not them you're we just mentioned, quite the QX the first a and across what see

Zai showing Lab questions back no I'm turn Du you. Samantha this CEO Thank now remarks. time. at to call further the I'll closing for

We Thank call. quarter may support you, and to time forward on look taking XXXX. second for you join today. call disconnect to the Operator. us now again of you the updating after to your everyone thank Operator, the appreciate I want this

concludes Thank today's Thank you you. That conference participating. call. for Goodbye.