9688.HK - Earnings call 1 2023

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Operator

Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's 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.

Ki Chul Cho

Thank you, operator. Good morning, good evening, and welcome, everyone. corporate a quarter providing well XXXX recent highlights issued the details as recently product first company's financial and Lab press the release of some Zai updates. results as in The press company's at call ir.zailaboratory.com. Today's Investor Dr. section be by of website led the will release the Relations available is Executive Zai President Officer; Operating and Chief Chairperson, be Officer Du, Samantha Founder, joined should Chief Dr. and Lab's by Smiley, Josh candidates; with Dr. Oncology Global Rafael Amado, our and will oncology discuss Head product President Research advances Development, of and Harald Head will Autoimmune about in and Reinhart, Infectious progress and therapeutic X made Neuroscience, President Development, Global of have Diseases, areas. speak who those we will discuss I quarter products our our market first and conclude financial results. And performance comments on the with of

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

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

Ying Du

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

to from the record generation in patients continue to of Our in first unanimous this of potential help about we sulbactam belief leading biopharmaceutical rich experience of in that Food beyond. I innovation turn Josh our help the the XXX caused will on and Acinetobacter. Recently, global leading at schizophrenia cancer in announce extension call and me next The human during President and to lung expanded to approval track treatment a ZL-XXXX. and recommendation strategic to health strategic from global ADC Advisory as global interim further Josh's the challenges to severe our neck our and over oncology franchise China to by Zai for goals conjugate stage demonstrate growth, program, important our from capabilities or we Phase continued best-in-class ADC provides program positive execution, TIVDAK business the results the U.S. the and the growth, very its now and We're readout Administration meet and global infections like better focus corporate our of Zai despite would global transformational look and our forward and to franchise, happy and the are and To Josh. EMERGENT-X This to the our from of beginning analysis us to market. head Josh? the and and that innovaTV and leverage productivity, in This reopening excited year. into topline study Drug of product strong for next mission positive our and portfolio support patients forward our of patients. I Phase opportunities. and on support improve and demonstrates and Chief KarXT DLLX, X driving pathogen-targeted for life-threatening needs ZL-XXXX, first Officer. options X deliver and we we durlobactam, strategic operational next global globally. product with company on China will develop China's Committee Operating pipeline have promoted cancer of with stage results therapy in seeing look enriched complements of space Lab's grow further quarter progress Smiley lung anti-body-drug our vision the a support this cancer ADC

Joshua Smiley

of new Thank few with years Lab our meet We're with look to a about unmet what be to next in in with us taking companies that on store to forward for and you, Samantha. I and the significant like move China Lab for the medical work for very leader Samantha I'm pleased excited biopharma forward. Zai year continue innovative environment in that therapies for innovation. the overall company this Zai the positions company role to this team is needs. rest our

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

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

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

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

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

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

gMG to approximately the XXXX for BLA XXX for in priorities, strategic China initiation China, a myasthenia at study employees X Phase We're gMG, in Greater registrational in its cell progress schizophrenia of made efgartigimod BLA a study and with the for and we've plan a earlier, non-small of efgartigimod for of approval excited communicated efgar towards China. With cancer. submission gastric KarXT bridging specialized Fields we experienced in the bemarituzumab a in we data for cancer readout subcutaneous LUNAR for generalized and about in initiation As gravis to have launch. full Greater and Treating the our respect The first-line or China. team Tumor of potential study lung

to better global that by moving recently we for corporate development. We also and I We're patients now. we end against report as by take advancing It million commitments: reach are the standards IL-XX reach Rafael? and released pipeline into XXXX right X a commercial Life. indexes. We Phase and over initiating strategy, ZL-XXXX full or XXXX the our global study with Dr. our global this Humabody health; rights, CCRX including and major X our continuing ESG benchmarking ZL-XXXX proprietary which by additional step more has preparing human of to accepted X Amado. commonly profitability overall our to call ESG now, act second, for create details call improve third, products will outcomes; achieve first, Trust or products patients X turn existing XXXX. And and are with ourselves We're to launch

Rafael Amado

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

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

presented in cutoff, studies. mentioned, TIVDAK overall TIVDAK the unmet in of partner cancer X partial cancer X responses. Meeting. at that April, from confirmed on X and rate was response neck for Treatment Phase with consistent met and treatment-refractory cancers in the head Samantha patients across Seagen XXXX At encouraging need efficacy with safety with Annual the XX% head data innovaTV complete new clinical our AACR study with significant XXX a observed As generally the was XX,XXX annually. response The approximately profile monotherapy China remain results

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

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

We of findings non-small with response patients biliary potential with cancer, XX% KRYSTAL-X a XX% cancer, the XX%. Notably, the Mirati of data presented option response of and results adagrasib demonstrated cancer, demonstrate the of tract Journal on working improvement aligned a advance colorectal solid the standard rate of this unresectable tract was to historically the other with objective cohort. pleased with cancer objective And these communication the patients tumor KRASGXXC few cancers. for now care These improvement X safety in we the it with Mirati mutated subsequently rapid closely and the reported adenocarcinoma, for are our Moving marked session patients adagrasib, tumors tumors, current to published study, to previously exist. and X with patients study harboring very in partner to Clinical where the standard of KRAZATI mutation patients Oncology. cancers mutation. April or cell program showed metastatic KRASGXXC was the and relative of was options to pancreatic which series meaningful rate for patients biliary the in Phase cancer. reported forward lung of pretreated Plenary updated the look at Results KRASGXXC or an overall treatment of treatment ASCO best-in-class the harboring of adagrasib care gastrointestinal with results Phase solid of with on pancreatic see profile including for that In

oncology global program, global to and antibody Moving activity. new showed be translation we as internal ZL-XXXX seems our early anti-claudinXX.X research signs development specific clinical ZL-XXXX that programs, showing of our monotherapy and presented data biomarker AACR, antitumor and well on at to tolerated from

TAMLIN ligand compound proprietary TAMLIN to In lung ADC increased the our cancer MediLink's our addition best-in-class oncology Notch the external small our is the to challenges microenvironment pipeline to innovative expanding we of ADC ZL-XXXX. an platform and leverage designed ADC next-generation building collaboration. Last is This a and ADC and an we're discovery the DLLX cancer current and/or neuroendocrine space is a tumor in ADC potential drug conjugate pipeline internal into in month, first tumors. drugs. ADC is next-generation cell program, DLLX overexpressed or by portfolio antibody both enriched with of global and overcome through lung franchise using TIVDAK, discovered that inhibitor platform. a

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

on expanding Lab. And areas. globally, progress discuss oncology floor and of repotrectinib for filing gastric ROSX are initiation our the Dr. Harald? excited Zai milestones I lung turn meet the the the track trial neuroscience cancer now, year, Harald other this in are very China an best-in-class first-in-class will China and our We autoimmune, cancer to in products, therapeutic abundance mutated in Reinhart about potentially of over of cell and non-small bemarituzumab both to including to at on we disease with pipeline infectious

Harald Reinhart

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

PANSS schizophrenia. Let's plans now primary third endpoint Results trospium, demonstrating which compared start a to are second KarXT approved. subscales, of at the combination X.X third registration XXXX. trial demonstrated the drug KarXT xanomeline to its in which developing measured were schizophrenia XXXX and made Karuna's also This week with submit quarter negative secondary that launch we with in KarXT, application by positive symptoms with XXXX factor half our EMERGENT-X March Marder are is in in the reduction of score of reductions trial with has partner positive X. in positive, in acute PANSS PANSS a the the negative of PANSS to in placebo from released as and points and trial. Karuna Karuna total endpoints negative, FDA the of new if

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

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

disease to quarter forward February, our review efgartigimod. XXXX portfolio, and Regarding launch We myasthenia NDA often submitted this FDA the of bringing for resistance. Much submitted IV XXXX, carbapenem-resistant are China the progress the or in CRAB Sulbactam-Durlobactam was BLA no be gMG gravis of in past NMPA baumannii Acinetobacter the second commercial We Committee's into And recently NDA of this by quarter treated and look We infection in novel in X in infectious where of unanimously with in Committee the priority in generalized with the the Pacific, frequent or December accepted treatment longer because drug expect confidence. about later. to infections was Asia officially VYVGART the to year. strong for SUL-DUR. can or granted adequately of month NMPA. China an severe of Advisory approval multidrug treatment favor excited approval this vote We're for patients voted of efgartigimod made the

efgartigimod submit in for SC, a also gMG mid-XXXX. We expect for to BLA subcu

Phase product, indication and Last China worldwide. to expansion with IL-XX forward least, we internally for preclinical support activities argenx, our in in preparation partner, our but global not topical on are X continue regulatory ZL-XXXX, our and moving developed trial. We for

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

Ki Chul Cho

you, Thank Harald.

expenses expenses compared for discuss $XX.X year million $X million $X.X ZEJULA, to period for selling for for Such compared to for to payroll-related decrease payroll offset net are same collaboration same our quarter of $XX.X expenses due quarter will million for as same to of to inclusion partly development million was XXXX; the per compensate same $XX.X common XXXX, growth; compared quarter same period industry net or $XX.X for million for of sales XXXX purchased head revenues count. SG&A compared for by United last higher our million to $XX compared payroll distributors the cost-sharing compared year. partners in distributors the share operations representing next in a a connection $XX.X infrastructure million Lab expenses $XX.X year-over-year for R&D included those first in of and the of period price. Research first connection Total the with and million invest years. Zai service in product commercial net States million in operational reductions a trials, loss the for to the in XXXX the from the to growth previously for XXXX, expenses, was and and gains. non-operating to XXXX The the the to the growth to to in related of increase due were NRDL. in XX% interest period increase for primarily loss to same stockholders products period that to Optune, the decrease in XXXX. and for and of period $X.X expand clinical share our first price in due rebates included for revenue the million in prior to of adjustment XXXX, in on from made period. I expenses professional new from per growth. in products for to loss and stockholders compensate NRDL product foreign loss net sales and to prior $X.X compensation in QINLOCK, million were or the R&D period XXXX, increased same the increased last compared non-recurring Zai with income in China quarter substantial for payroll-related NUZYRA Greater for including XXXX, quarter million and and results head first the the to continues $X.XX product a sales $XX.X to were the customary $XX.X income, of of $XX.X initial year. Note its first net primarily financial QINLOCK higher $X.XX. a in of their $XX.X of in in over loss XXXX same million period in reported million $XX.X was million primarily our revenue commercial net at attributable XXXX than common million NUZYRA, of compared quarter negative The representing attributable year-over-year anticipation prices The currency XX% count $X.X Now first in product faster and to distributors compared fees This China, revenue few higher Lab the million

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

Operator

from Michael Our line first Yee from the Instructions] question comes [Operator of Jefferies.

Michael Yee

the expectations efgartigimod, TTF for at NRDL are lung second of On for lot timing should had expected our what on cancer We time that the question coming guys data NRDL would approval? your up ASCO. the of for and at ramifications is, work you that focus the know for what XXXX question. And for getting give us time and waiting are on a expectations update X there how your Can obviously, would are for be that that and first I questions. our be quick in and you an That approval. or lines

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

Joshua Smiley

Good our questions to you. I'm executives Michael, going morning. this it's hear to Josh. the direct to from

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

Rafael Amado

Sure.

China. this So study. Clearly, data of the the second-line implications for a this is is about

is clinically meaningful in is, received inhibitors question significant with first-line. applicable checkpoint would if say and patients So IO most the patients data therefore, have And that frontline. in receive the

patients checkpoint mutations. the it in mutations answer frontline, much with the that that and tend checkpoint every mutations EGFR I resistant add is they of patient get to second-line. receive don't benefit inhibitors and may with in addition actually -- particularly Oftentimes, think not that to

is think, checkpoint There's and to some applicability study also some which in this synergy is inhibitors. think we between of I And there really So I this keynote is BXX. able evidence, frontline the demonstrated in be study, there. will which corroborate TTFields

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

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

Michael Yee

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

Joshua Smiley

mean eligible again, the we well. whereas approval an sure. I as but to as I quickly going going well, possible for don't summer. things know we Yes. a have like would until Yes, get And XXXX think say, need reviews we I over for negotiation, And are be it. are would as we approval to

Operator, everybody keep next question, updated. please? we'll So

Operator

Our line Citigroup. next from question Yigal the of Nochomovitz comes from

Yigal Nochomovitz

gastric? press For release in China? also on in the bema, just what about FORTITUDE-XXX lines you the the X for you And between time just launch the X And joining Phase trials, -- gastric? X first-line trial that when current global you can those the Xs, FORTITUDE-XXX. drug that Phase both running could When explain Can could in differences first-line study please, you're mentioned is that and talk the then in read view out? when

Joshua Smiley

question. the Sure. for Thanks Yes.

Rafael, these you. think for are I both

Rafael Amado

Yes.

second some standard care cancer, about. are FOLFOXX intensity results studies not [ X start such been of plus PD-X the of PD-X because started the That or treated, part is variation studies really with So really is inhibitor the used Yigal. I'll There in -- chemo the There ] a has before are came these way most XELOX sometimes that patients have as PO used. chemotherapy they question, there pembrolizumab. of gastric that

have the that's is bemarituzumab chemotherapy and other with FOLFOXX it One, bemarituzumab with studies. why uses PD-X. So X we plus

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

of been the immediately. alone But alpha, we'll that study level study, and chemotherapy trial be we're some of Actually, by enter China. with with ongoing followed from issues, discussion cetera. and diagnostic, be will study expression Amgen. the in approval to first will start, There's to the that and FGFRX So about normal after having just ultimating is ready et is shortly which it do the the PK is

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

Operator

comes Anupam line JPMorgan. of question Rama the next from from Our

Priyanka Grover

is on Priyanka going Or to the had is just a We on Anupam. And they're a pipeline what dynamics for development of Day? at or give Can and This question. one on in us be focused? you commercial China? for Investor more products to pipeline the expect preview if it more focused potential

Joshua Smiley

Priya, jump Billy it's and Josh. then I'll start, please in.

not have this a time an quite good Investor coming some it, we'll in-person of particularly out ASCO to had there. time that of updates for the We do have thought Day and some and was

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

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

Ki Chul Cho

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

tuned. stay So

Operator

Great.

SVB Chang from Jonathan Our line next of question Securities. comes the from

Jonathan Chang

Josh and to Christine. Congrats

ADC you pipeline for as do and and in growth commercial what the context see lines thoughts engager? program pursuing assets, your beyond? DLLX XXXX tell in broad second ZL-XXXX? discuss us a construct the and of clinical about stage of with more question, my T-cell the drivers bispecific First question, most itself can company the you a on associated The an the and And with expanding time and meaningful versus

Joshua Smiley

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

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

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

continue and to remainder of certainly, So leader mentioned continue we in on to would a in driver. ZEJULA we the to revenue penetration, grow well, secure looking place forward expect, of QINLOCK to we continues perform we're that new as beginning and market to for class growth as particularly growth that first-line as share the drive will a the and drive course, volume NUZYRA then sort good setting March as in and of good NRDL XXXX. upfront,

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

a are drivers. growth lot there So of

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

Ying Du

No.

have well. pretty covered You

Joshua Smiley

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

Rafael Amado

activity this We ZL-XXXX. Yes. Jonathan, is the product. we have were so impressed pretty of as you yes, with TIVDAK. preclinical And know, this

on is the is This inhibitor, topoisomerase target benefit has to quite And risk the high payload the it potency And the is that pipeline. this and case, high payload really then permeability. product. this linker of to are based clearance DLLX. a the not good and and you antibody antibody, as know, and specificity our complement for the ability and a ADCs ADC So of better

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

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

because ahead advanced technologies to that also because product seems So also many ADC with. that was they're like superior this that and we've company other was a more of And a technology moving it that has also there. out it seen

we affect other avoidance type DLLX, cell terms lung So didn't that's bispecifics, stability there benefit have a is to toxicity a and why from higher think cancer. space it's the and and data, demonstrated neuroendocrine trying opportunity actually been own the as potential But And bispecific Regeneron. use it's expand of CRS And tumors, technology been progress. risk, or we the of second-line and of perhaps by in chosen chose then impressive Amgen's we to by because We on medical CDXX could unmet refractory activity ADC. And of and have which bispecific a in such given the validated opted have with that's target of IO have potency it. how the really we has hasn't they the here, to in lot to small where difficult chose our an also I settings they need. well, the real area there linker

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

Operator

Goldman Sachs. Our comes from the from line next of Chen Ziyi question

Ziyi Chen

the third and quarter, A budget couple is, more you of stage, pretty clinical questions. controlling been in XX the now have while based on one tight. also fourth running Number the first quarter, you're quarter assets

specific expect prioritize adagrasib. understand should factors Lab key could you're the we're is programs So partnering is we resources the to would players the When this on China? quick on trying you sure A one filing plan of Particularly local trying determine the the Is the competition also updates make the in that licensing strategy? first filing is is probably in assets. more while we Zai for what -- visibility of time going peers the China? progress one of properly more potentially to considering management of there with question how their China on line how any ADC to time in programs are are that and saw the allocate some on those the regulatory make adagrasib assets? Second ahead you that to

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

Joshua Smiley

can to Jonathan, for allocation. Rafael, can X. talk the start adagrasib, business business can try resource you cover you context around provide broader we'll Billy, And development strategy. any about maybe the make all our Rafael some Thanks development. about you Then comments, on questions. could maybe

So I'll start with Billy.

Ki Chul Cho

for question. thanks Ziyi, the

kind whereby we're Zai scale would to So say, able make that at I sure in what organization's to be sort life turned I have we drug maintaining a about think strategic very X while the a relevant anticipated this so us, that to priorities, level we important the going think time. cycle, achieve same growth our we at productivity X.X have of we of, corner and i.e., launches clearly, next Lab or years in point over of

But income foreign should operating if snapshot and also you expect results would therefore, such than you of currency expenses. quarterly actually you profile, continue is from And that that improvement line non-operating here you now. faster as revenue have gain. interest from the that saw in our a growing see So namely items, items see some on yet to were

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

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

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

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

Joshua Smiley

Rafael, maybe cover could adagrasib. you

Rafael Amado

Yes. Sure.

earnings i.e., So is with performing lung call as referred are tract. data I well. the of to previous data the excited in we pretty second in This tumors colorectal, biliary obviously we solid which that well as to adagrasib data extremely alluded pancreatic across line and the today small cancer at cell DLLX about and is

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

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

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

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

we finished make, required soon again, and comments our we best really believe So don't it's did available will PK think I competition. do behind this time, made the But the for as in which to the we comment last this that right it we we possible. And There's last try I'll filing, but don't any as study, already we are make to actually. start this to field.

when to more would to so lines, discuss data patients we have time these go PK. And we Chinese CDE from

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

Jonathan Wang

strategy. question for BD you Thank on the the Yes.

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

think BD is multifold. In fact, I our strategy

more I Mirati, late-stage couple the are Number of of elements the well So which known those type there we'll to are for assets continue do [indiscernible], the we it. deals, one, think maybe to strategy, The DLLX, our which the TIVDAK, second is one acquire with and to it's discovery global our obviously, company the rights. latest Seattle complement this regional part with in-house is help Genetics. In rights of a strategy.

in is I success assets. good it at think if team the rigor scientific the at from comes look BD our our scientific picking you in very evaluation. And as really

right of from you strength rights making come promising whether data to selected as think where we're building lot China big deals I global the want these those portfolio the from ADCs, very globally very we come to such areas, or as extend a of case actually leverage data. know, particular regional in of and company assets. And others, shown and progress So and today, China synthetic particular this synergistic in early in assets a ADCs, demonstrated is or asset positive already has

BD a I you. certainly So we more kinds we're do we evolve as continue types of that going you'll very of in we these the forward. think elements. evolve will creative profile type with of as excited future. do would by to will be other Thank it. and hear about hopefully, company, there more other I think And And may deals And deals

Joshua Smiley

Jonathan. Thanks,

question Next operator please.

Operator

Our Securities. comes Guggenham from the Seamus Fernandez next of line question from

Seamus Fernandez

Just quick a couple of questions.

KarXT, commercial of patient sort you to the to relative versus for likely overall of be size launch Can the us the generic on necessary of just undiagnosed market is just opportunity. can sort help population. just us utilization really how remind understand first, the you is presence So of kind in capitalize of country what on kind the

then on just of has get but another X that the you're a new thinking in topical relates how post reimbursement the sense about gross as the for treatment agent across been to in thinking about be to or challenges good efficacy, market KarXT in agents net of come space. relatively launch see commercial really have continue approval. And with second how That on trying the should Those to we coverage. Just it to of area we better dynamics slow opportunity agents the to psoriasis. question what and board is

and IL-XX the you'll So or Is for an that to pursuing just opportunity how it of perhaps you that topical HS spend about outside opportunity purely with psoriasis? are the potential opportunities associated thinking be other pursue it?

Joshua Smiley

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

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

launch is centers. the in cover or so of at generics view somewhere heavy the our think can range reps I prevalent. So treatment are sales probably XXX

I Harald, of KarXT that I about aren't I little like think about can why certainly, patients thinking talk about either Harald utilized today. responding or think, IL-XX. But and to can are compliance may the And that China then, otherwise, come. and a excited you therapies benefits current others, well talk we're the olanzapine terms bit the well think presents in in opportunity who from --

Harald Reinhart

you. Thank Yes.

from The is of efficacy or the really adjunct in the that in an patient either another opportunity shown kind as to that and a with so efficacy antipsychotics so schizophrenia different in as -- just existing stand-alone. seen a regimens existing it's we complement trial a already and this last the see we've this the Karuna as First, drug transformational KarXT clearly compound, this signal that's treatments efficacy EX. in was population shown see of we studies, EX EX the similar great

a effort of treatment So There in to new activate in And with the we've is in undiagnosed market. already government there schizophrenia. as more told is China, a by in is the an the area that said, lot this I meetings, schizophrenia previous think country.

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

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

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

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

Joshua Smiley

you, Thank Harald.

Next question, please.

Operator

the Our from of Credit line Huang next Suisse. from comes Yang question

Yang Huang

X have I ones. quick

progress. First is commercialization quarter first on

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

volume progress So momentum? year, NRDL my of question in there commercial we question impact expect kind remaining is -- gain should drugs for accelerated quarters That's kind potentially of no COVID given first the the will be first and is to more question. of the should the X

KarXT. on is question Second

time you bridging pretty the for this bridging study initiate when mentioned the us to and of potential kind the you and soon design a on color line give year. So KarXT? can are scale more study this of going But you

Joshua Smiley

on. for or question. KarXT. and commercial if cover is Samantha, are the for which you first that COVID about you going one, can And Harald, Karuna of outlook then talk the sort other the year you can and obviously, Thank impacts things

Ying Du

question. Thanks, Sure. Yang, the for

said, China, The the inclusion months COVID you also NRDL and like first impact do month. we experience X in last

forward, much start we'll seen going we have However, COVID from lesser the March, effect.

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

Joshua Smiley

do Harald, want Thanks, add? to Great. you

Harald Reinhart

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

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

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

Yang Huang

it, finish So study? bridging when that do expect we we sir, can

Harald Reinhart

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

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

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

Operator

line the from question next comes of Rebecca Bernstein. Our Liang from

Rebecca Liang

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

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

Joshua Smiley

Josh. Thanks, Rebecca. It's

added Xst. everybody products March X to Just those were that remind effective

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

QINLOCK marketing sales we're you. China-based will COVID volumes that confident across of growth next a bit our So sales quarter X quarters. across as to products, the to Yes, than the in both Thank different -- we see and net NUZYRA you're Samantha all little and mentioned, you of see QINLOCK. But challenges QX quite related again, efforts. for just the over good I seeing not what think you'll saw them and first beginning volume should in expect

Operator

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

Ying Du

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

Operator

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

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