Zai Lab Limited (ZLAB) 2 Mar 232022 Q4 Earnings call transcript

Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab Full Year and Fourth Quarter 2022 Financial Results Conference Call. [Operator Instructions] As a reminder, today's call is being recorded.

It's 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 full XXXX year of The press release website available in ir.zailaboratory.com. the Relations the at company's Investor is section

will Lab’s will of with Chief Dr. Today's of opening Du of Global we’ve be Zai comments remarks Dr. year discuss made speak XXXX President Officer oncology our Smiley, Executive areas. on Dr. further candidates; in with and Samantha those by will advances Chief updates three full Oncology quarter Global Officer, Harald Development I Amado, performance and Autoimmune financial strategic overview Head Neuroscience, highlights, conclude business the therapeutic will provides discuss Reinhart, and the Operating Josh Dr. our call priorities. Diseases will Du, of President results. fourth an about and discuss led Founder, key Development, And Chairperson. After our Head progress and XXXX product Infectious products market and and Rafael

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

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

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

On the Thank I'll that XXXX, longer you highlights our Hello, growth in we pandemic XXXX COVID-XX exciting China, thank product, from pipeline. today. expanse call, this the everyone, sales us and would joining each market you, discuss from Billy. with program what XXXX in and term. In four made accomplish in challenges despite our and all substantial across for broad and

including to continue globally. potential [indiscernible] cancer, cell The readouts or data lung small marks in non and demonstrate profile and quotation in [indiscernible] cart-T Our DMT. year numerous that first-in-class adagrasib best-in-class announced ITP during positive in the schizophrenia.

successful for study, We have pleased the pleased significantly to risk are on collaboration Treating the QINLOCK foundation. our our added reinforcement to Seagen to contributed and deepened to cancer NUZYRA [indiscernible] our several We're job have also our repotrectinib through in with study, franchise And We talented TRIDENT-X continued Tumor registrational Fields solid to strategic studies, LUNAR team, global enhance we in women’s XXXX. further TIVDAK. further including building

world-class commercial and in is with a Lab leading scale, biotech Zai pipeline, China. global a various growing portfolio a already

year, overall this launch X and and by products are additional corporate profitability at We commercial achieve preparing of expect end to achieve the to XXXX. profitability least

accelerate our in activities, We advance patients discovery we to as including medicines to our product will pipeline, need. internal R&D continue seek in and invest to

positioning also portfolio assets with potentially and strategic We to strengthen aim partnerships. transformative our and

environment biopharmaceutical companies supportive of will Zai regulatory to global Lab. innovative the that continue like believe We be

globally. success continue in China pursuit to build our human We goal of will on improving and in of overall health, our

over turn the now Josh business detail. to and key to to discuss in updates, call more other like XXXX priorities I'd strategic Josh?

Thank you, Samantha.

welcome Global to domain leadership highlight I'd our recent team. December, to were top talent like attract to expertise. Rafael deep continue global we of development we In additions pleased Research of Head XXXX from team Oncology in mentioned, few a products. Samantha a worldwide across Amado and As and leading with oncology to Development. broad has president, Rafael and discovery Dr. in Allogene clinical experience us joined to range he our as

a joined industry, the Huang than discovery more worldwide. as Huang efforts Peter will at to companies. of Chief our Dr. oversee XXXX, XXXX. and medicine. of also Officer. an January our in appoint Vounatsos global expertise and executive significant service China to Dr. leadership brings to experience as lead Vounatsos experience Scientific in were extensive commercial in years His in including of Board management XX the We November includes Directors our leading Michel Board and amount In biopharmaceutical pleased translational Mr.

anticipate to for exciting be We milestones. significant expect a achieving year very we XXXX many Zai, as

the on the submission approval mid IV BLA generalized formulation XXXX. gravis, launch and for expect subcutaneous And for BLA for front XXXX. or in efgartigimod First gMG commercial regulatory efgartigimod a of in efgartigimod, in myasthenia in we gMG the

small pleased by to also We're acceptance We of cancer plan ROSX+ the Sulbactam-Durlobactam cell baumannii. also treatment non application the year. Acinetobacter submit NMPA drug to NDA in this a advanced to for caused of infections NMPA the lung Repotrectinib the for new for obtain

XXXX. products, year. faced expect And growth, growth challenges us, the with our delivered COVID good commercial now last strong COVID behind challenges we Regarding we even we in revenue mostly though in

cancer to the ovarian expect ZEJULA sales We PARP in China the for in year. become this leader

sales ovarian September, total of we recurrent of label the quarter setting XX% for cancer of decision. share continue the some sales. FDA on ZEJULA's indications, China hospital been gain the of there's around the hospital back PARP U.S all concern reaching Since XXXX, fourth in across the to In last

restriction the to in approval the However, the NMPA China. ZEJULA as we've previously U.S do for expect communicated, from the impact we labor not

following significant sales this in and their inclusion the QINLOCK on increase NRDL. the a year of anticipate we both NUZYRA, For products

XXXX, and partners, thrombocytopenia of and data quarter the and readouts for to ITP, nuclear key second immune the in research poly milestones for the half inflammatory Moving or vulgaris demyelinating line or forward in of looking for pemphigus radio clinical PV -- subcutaneous both nucleo in Zai XXXX. and development the for top efgartigimod we chronic CIDP neuropathy second are chronic

We first the half lung also data non Treating full XXXX. the study expect Tumor small in cancer Fields of readout in of the LUNAR cell

forward look to data GXXC-mutated in cancer in update lung in first-line combination for also the cell XXXX. with adagrasib half non second pembrolizumab We small KRAS clinical of the

will half the second clinical In the Phase study cervical enrollment we in cancer in XXXX. terms X third-line complete of TIVDAK first and global developments, innovaTV in XXX the of of

China Phase KarXT anticipate mid-XXXX. to study also study And the first-line for global bemarituzumab China of we FORTITUDE-XXX We plan in initiating mid-XXXX. in cancer a gastric of join bridging in in schizophrenia in X

continues design strength advancement large treatments add patient in potential emphasize the these gastric areas needs. of for these like to I'd of cancers unmet lung and to

We pipeline. will advance invest our in continue and to R&D internal global

psoriasis plan full of the global a terms milestones, In with research global Phase study X we development chronic initiation plaque key move potential in of for in ZL-XXXX into XXXX. to

half X We the for Phase CCRX first also plan global or a ZL-XXXX XXXX. study initiate in of to

Of partnerships course to for regional evaluate opportunities, development addition our business the pipeline. continue transformative and including opportunities we also global and of potentially

Zai and business. trusted partner entering into and of brand strategic value and believe our look that to create a Lab choice, significant existing more will we synergies is we deals forward to

advances Zai. Rafael I call his oncology Before Rafael discussing product with Dr. earnings to remarks respect I'd welcome before Amado like will for candidates. with conclude, make introductory to first

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

company's joining time in be I'm Lab Josh. to a in history. pivotal Zai such the you, Thank thrilled

a work across the of and to team. cancer and scientist, various had and privilege As on lead to modalities the development form physician R&D approval I've therapies

potential, made to research for to continue have our and Zai with step build [indiscernible] outstanding ambition in I with excellence colleagues product to globalize the capabilities catalyze to in easy to of ambition of transformational innovative pipeline. the in help and of capability Greater Lab global a forward continue expansion career. oncology. oncology broad combination in China, portfolio therapy The to look next Zai an together for the choice and with a execution, expansion as development products development working my

the quarter make XXXX. we all XXXX, and franchise In have progress to a Lab's fronts, to of year Zai productive expect on in fourth oncology continue

made Fields, a the For in improvement overall its Tumor statistically XXXX, announced that survival meaningful and therapies demonstrating endpoint, significant NovoCure primary in standard and along. Treating Lab over clinically LUNAR Zai study January

docetaxel alone. and alone. And when improvement tolerated as with survival with to experimental with a positive also arms immune immune inhibitors therapies compared checkpoint in study an and LUNAR treated trend well checkpoint overall was treated TTFields versus inhibitors The with in overall TTFields or docetaxel significant when [indiscernible] meaningful of study. patients showed clinical survival in enrolled those statistically are patients were the the TTFields in patients

excited about XXX,XXX cancer with year. TTFields alone lung are new the common cancer most We to is China patients. approximately each type cancer the lung In help diagnosed potential cancers of

endpoint LUNAR stage broad underway certain a survival, of hard and types pancreatic be to about a pleased is were to LUNAR are We optimistic contribute cancers. made of studies enrolling. primary part study. cancer potential the Because to late The include other its we're Zai prevalent its of actively range across treat in and overall

pathway adagrasib, patients small package mutated one have non study regulatory China Moving China, accelerate lung in who adult the with study XXXX. or will by the confirmatory the least [indiscernible] data cell leveraging second XXXX systemic KRAZATI cancer advanced Zai prior KRASGXXC joined KRYSTAL-XX granted small In FDA monotherapy in to for accelerated continue was approval, we non cancer therapy. line in July now by and the December for to approval FDA the received metastatic it locally global cell lung for at with Lab global

whose granted England to and adagrasib therapy patients New with in an of cancer colorectal with XXXX, following with cetuximab results the in cancer with KRASGXXC-mutated, treatment the Therapy chemotherapy Breakthrough FDA the prior Medicine. advanced has progressed Further, published in Designation combination December Journal in anti-VEGF

and activity and submit in patients year both Approval end forward demonstrated advanced KRASGXXC Accelerated in news plans to in pathway. supplemental the CRC metastatic drug CRC pretreated the by with XXXX, with Adagrasib application as heavily anti-tumor combination third-line+ cetuximab. Mirati with KRASGXXC-mutated move monotherapy

[indiscernible] XXXX that remain KRAS to is metastatic enrollment best-in-class expected second line by randomized Zai We June and XXXX. of colorectal study in end potentially in enrollment initiated the in is inhibitor the a confident adagrasib completion GXXC CRC the cancer.

all cancer, small lung mutation PD-LX patients December of KRYSTAL-X reported pembrolizumab cell combination Phase that across KRYSTAL-X trial evaluating recall the in cell KRASGXXC adagrasib with Mirati first harboring subgroups. treatment the non non and in in cancer for X line Xb small results line first lung from Phase a XXXX For cohort

are will of PDX inhibitor We first for a work and results with these we feasibility -- adagrasib. plan the a first of are a to the on [indiscernible] tolerability inhibitor, PD-LX regimen our demonstrate to concurrent inspection checkpoint that line combination continue excited and KRASGXXC and Mirati

first cancer biomarker of regardless maintenance status. were We In announced the this line pleased XXXX, July full X indication granted that XXXX, approval December February NMPA we we ovarian to on the Phase exclusively from data NORA the new interim survival Virtual Lab session. at ESMO in platinum-sensitive study Zai with a conducted recurrent X Plenary cancer overall patients present Chinese ovarian by

placebo overall compared was at receiving longer status months, of months patients the of None identified. ZEJULA numerically to the XX.X issues for the safety in Median group. were survival regardless biomarkers XX.X

study to present Phase the the expect We OS X sometime this year. analysis final of NORA

initiate very at study a global data the oncology and our antibody product, research excited or antibody. the will presented XXXX pipeline anti-CCRX we we're in for development an Phase abundance ZLXXXX, our to internal ZL-XXXX, half AACR of now a first plan programs, anti-ClaudinXX.X Lab. at clinical an or and poster our potentially With And X of Moving to best-in-class in biomarker an translational about upcoming Conference. be Zai global first-in-class

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

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

start VYVGART Let's or with efgartigimod.

partner continue our progress. make excellent On the and regulatory argenx we to front,

is announced the myasthenia recently accepted BLA PDUFA priority Sub-Q FDA Argenx The treatment the June of XXXX. patients that efgartigimod gravis. with date review, XX, for a adult for has for generalized

quarter launch a we patients for approval the this efgartigimod the submitted year. BLA treatment XXXX in for China with in IV reminder, the commercial gMG in of of As second expect and

for BLA gMG XXXX. for expect in also a efgartigimod mid to submit We Sub-Q

trials indeed, February. enrollment indication We support begun two on this China proof-of-concept argenx worldwide for in has autoimmune continue in renal diseases expansion and to

the bridging for our and partner Karuna trospium, in in KarXT, start a combination accepted development has and to developing Moving plan of which been expect we by to acute clinical xanomeline the schizophrenia. are Zai study mid XXXX. China with proposed we NMPA, Lab's

EMERGENT-X trial results this XXXX. Karuna’s As you August from were recall, released

X.X at This endpoint reduction pivotal placebo its statistically PANSS week score compared demonstrating trial significant total KarXT X. primary with made a to in

in submission Phase schizophrenia an Karuna in for NDA data from first addition, top to In in expects and XXXX schizophrenia trial line results quarter of X FDA the May the KarXT in EMERGENT-X XXXX.

several Regarding diseases portfolio, developments. infectious noteworthy we our have

granted infection December January February, submitted accepted of can carbapenem-resistant one to XXXX. baumannii no the treated, look where First, the Sulbactam-Durlobactam because in month or this SUL-DUR. review treatment officially drug and was NDA severe We forward by resistance. are the infection We XXXX. in later were Acinetobacter to NMPA in for CRAB We the and NDA bringing And often China to the Asia novel longer multidrug NMPA. of frequent adequately be priority Pacific,

IL-XX as study mentioned omadacycline psoriasis we that Phase happy for listed our NRDL Samantha earlier, progress For continues are ZL-XXXX of report was chronic as And product, initiation to internally to of China's later successfully XXXX. NUZYRA in X developed topical January it XXXX. towards in lastly, a plaque

progress our speak will and about Billy with results. commercial products now financial And Billy?

you, Thank Harald.

growth, by NUZYRA to Optune, to of well perform PARP demand QINLOCK ZEJULA, cancer and strong achieve during increase continue revenue driven sales ovarian ZEJULA fourth XXXX. execution. solid products, the quarter four its of Our and for share marketed commercial and continue

sales to China year. We expect ZEJULA become in leader this the

For to market Optune, starting clinical and our on recovery, we improve expanding team to significant and see by the survival. Optune coverage growth about quarter. access are year, commercial COVID achieving including revenue fourth supplemental throughout insurance focused solid situation the its [Indiscernible], given in last benefits strong continuing potentially physicians educating for a

Optune from was by XX plans, or year. XXXX XX, provincial prior plans up to December supplemental of XX such As municipal covered insurance

January drug and starts pleased XXXX, China's We're month. QINLOCK list to this have added national to implementation and NUZYRA in reimbursement

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

to FcRn For approved efgartigimod, getting with specialized and experienced We're pipeline at plan blocker the have commercial product potential. for the efgar first only and later launch U.S and year. launch. about a team XXX ready this with employees We

excited We potential are about China. blockbuster its quite in

XXXX, year-over-year in were the full Total year million the million, year million, financial Total year-over-year of discuss in fourth growth. periods. Now growth. XX.X% prior for year XXXX year, the for million I $XXX a fourth of quarter our to the compared $XXX.X compared representing revenues quarter full to $XX.X $XX.X results revenues XXXX a will and XXXX compared were prior XX% to of representing

$X.X million compared year XXXX to in for of $XXX.X million million XX.X% Product a full Optune revenues $XX.X for growth; the $XX.X in year-over-year for zero XX.X% XX.X% to year-over-year to $XX.X compared and QINLOCK million to to ZEJULA year-over-year growth million XXXX, were $XX.X million NUZYRA for a XXXX, in XXXX. close for compared for a $XX representing million XXXX, compared growth and

same million in $XXX.X the compared million in XXXX, were primarily decrease payments expenses licensing for in R&D to upfront agreements. $XXX.X to new lower expenses for The for was due R&D XXXX. period XXXX

to expenses compared Excluding upfront R&D licensing agreements, $XXX.X for $XXX new were in million payments in XXXX million XXXX.

compared due United invest the payroll expenses same expand to XXXX. substantial increased for growth Lab the to operations in anticipation over and were few the expenses in and The was next headcount SG&A its and States related years. of in in million $XXX infrastructure from XXXX, as China primarily $XXX.X Zai increase for higher period payroll the commercial million continued of to

business to loss share Zai $XXX.X net new net common loss Lab to of of of attributable attributable to net loss for XXXX. stockholders lower payments stockholders loss continued growth reported loss million, a related The sales. a common of and $XXX.X share development $X.XX XXXX per decrease million, or per the product a in was to and primarily to compared or $X.XX for a activities, attributable

billion, cash billion XXXX. XX, XX, $X.X and December of and as restricted equivalents, cash to cash XXXX, short-term totaled $X of compared As investments, December

Operator? over the the line to like to call would now We up turn the operator questions. back for open to

question Yee first [Operator ahead. Michael from Please The go Jefferies. Instructions] from

are had trial our in all partners. sort from a obviously China how And and then from cancer. to going for a and to of there sort TTF recently up a One also a questions. with to big as us opening needs standpoint appreciating as guys, morning real launch regards was as and but how the et and, to evolves of standpoint, How opposed you clinical just maybe We how announcement good first, that -- COVID to filed Hey, thanks GBM, relative from you relative execution that about probably reimbursement commercial both execution side, side. in get cetera. in That is about could you. things is two lung that opportunity that give second that with And update particular are time pre-COVID? the opportunity? progressing, was thinking think Thank

Hey, thanks, and can in. questions. colleagues Mike, for get Maybe started chime your other I'll

to with faced think through this ground clearly is all being of reporting well of familiar end far, it continue impact, like the the the some semblance looks the and course monitoring so on into back as from as we and everyone 'XX, We're of COVID the normalcy. enter optimistic wrapping everyone kind challenges it going as very year. we're even so I like situation opening, up we'll quarter, of XXXX and first quite looks closely March, getting in the early kind do spring and the that -- now, of that. into in and right But So good. way beyond And

that, So here, right in traffic it's so pretty now, quite energized. I'm activity and not the And is active pretty, much. great and buzzing, Shanghai, you're so to if see

the to cetera. patients, consistently to the and et partners, seen a and R&D in has our job any and our resilient we've for the the think -- But up community, really team terrific side, slipping performance you've us a physician to development. and with I the done with not clinical past, on the [Indiscernible] have the learned commitments the team challenges COVID on R&D navigating commercial piece, very our in of side execute in the of

it -- managed smoothly, of and have we think, so would proud we I seen that, well as had as commercial, growth. for So consistent quite quite you us

what the December outcome more of I to a looking forward think in, fourth relatively and even given and quite happy speaking, parts end I quarter environment. think, of the came with through normal happened, this year, early

be expect a to XXXX strong So we growth. for year

On was commercial more the part. the opportunity I Tumor really part towards question reimbursement Fields, Treating and think your on

that, heard this early Policy like Reimbursement like probably possibility, there's a technology say before it formalized Fields, us National you've Treating for year. as be can Tumor So NRDL, we think that a as

if on the be And of sort -- significant. data, to we this something upstream all else. mean, we'll of opportunity I subject but significance course, we'll quite LUNAR, of standby is everybody And for for of that. So kind to hear the

number think half I cancer, for and and about type treatment and Stage there's, dire. that small people significant Rafael said new year Stage of going in that there's to with non know, cases and quantum despite whom are XXX,XXX medical that XX% options available unmet is a in lung be pretty X, cell of at X, per need

data for could is So again, coming that substitute us. significant. And blockbuster opportunity opportunity year. should this be out The quite sometime be a program it

you. Thank

Thank your question. you for

the ahead. next go J.P. from taking question. Anupam Morgan. now Please are question by. Rama stand We from next Please The

line open. is Your

guys. the Hey, Maybe Thanks so much question for broader taking a question. actually.

the by lot You insurance. to reimbursed like that supplemental what private private pay look and pay guys you being of XXXX timeframe? see currently XXXX portion with and model revenues greatest mechanism? do you products this talked so supplemental out and insurance? are which Thanks as with portion reimbursed And much. And have a about What does

this to want one? you take do Josh, Anupam. Hey,

Anupam. about Thanks XXX of with we've at supplemental the the I'd of for end covered number the million few years. Hi, of XXXX over side, million to question. and XXXX. insurance Certainly China end in from at on last XX the seen overall grow environment pleased development its reimbursement people say first, Sure. we're the the

that few to number countries quite sizable other We million to somewhere and start expect the grow compared look that around next million, at over if between you the XXX to XXX years population, world. a so to

we Optune. in see directly benefits of the that's most now So positive that, and certainly

three I So in it out, XXXX NRDL, while our just products other weren't. don't has think terms looking ZEJULA of the we covered results, break percentages, through at

so just combination at NRDL the some macro level, and a through mechanism, commercial, were pay. sales or of very insurance our about supplemental So a through of rest XX% private

think insurance for the But growth launch a get I and we innovation NRDL see going drugs there. be think access patients forward, supplemental we we really some products going of or our forward in that experience. in And they innovative really medical though, internal provides a sizable look for on with we for of certainly kinds Billy strategies progress important to for the are our that number our ultimately physicians the either device alluded the to option important to at pipeline developing, even with as side, that earlier opportunities. have are partners, to

think, to to So great great China strategy bring as as our that And Chinese to I relates innovation as want Anupam, broadly we patients. to do is innovation, possible. it

We're efgartigimod options certainly time. amount In with multi lot strategy like to layered of three to the robust have lead we'll provides we're sizable them. have a relative over in that some drugs, economics more pleased way the a our Thanks early leverage but seeing now for in for net quite question. the to will on for China, for lot So associated opportunities. opportunities, with a innovative price flexibility continue the be NRDL access develop more patients we and and system other year, NRDL words, we this patient now now pursue the products the

Thanks so much.

Thank you for your question.

from Please go question. We next question are The taking Nochomovitz Citi. now next Yigal from ahead. the

is line Your open.

Thank you're for Hi. the SG&A. and taking marginally on upfront you maybe R&D said I year-on-year year-on-year questions. that think on flat you higher Billy, basically

end the navigate with line clarify and OpEx you is the might the by could line to if drive to the Or spend you the year-end profitability still overall to forward basically going 'XX? with top corporate some have to to by Just growth top flexibility growth be 'XX? going just profitability flattish of accelerate Thanks.

Hey, Yigal. Yes.

correctly. that right, So heard you're you

of core R&D, at was XXX level. it much terms pretty the In

over modest have eight, the increase. we And calendar, know, a year, least think development the This a we 'XX. 'XX, year-over-year next years, pretty flat approvals and have queue. as you at very anticipated can launches roughly given active X around the you expect I So in

think expect -- we be that that should range. but I to at So

Now or for sales to as even we're we to year, going commercially with have target so build we the we for we said be new team efgartigimod be launch. profitable, a that have SG&A, [indiscernible] this profitable, commercially

So that's great a be. place to

You revenue can expect continue as we additional see to as that products. to operating increase the and increases leverage launch

And have, you and of think so there a lot relevant that is scale, great and of kind that's a flexibility kind a I a of balance growing we when sheet. place to have strong be a

of all And are engines establish on some preserve good cylinders, baseline all sort firing the you can optionality. and

it. Got

really and just clinical Hey, Yigal, plethora one them. if execute maybe programs, follow. on we've just to the line and grow two the our advance But priorities going I'll Billy, got those is our is, that we top quick profitability point to to to a are add, of priorities,

and add flexibility and products our expected health So, and franchise, Billy those on mentioned. over if the then things profitability few and the the us to years at growth ZEJULA the give are that that, like TIVDAK women's going are that next look drive you of top

invest to the in invest We clinical sales continue force, continue program. to in

to profitability it's side, we us to we as to that the more come. again, execute around built. we that is going portfolio So expect If along

just real QINLOCK one on fast, housekeeping and And NUZYRA. just

you that the release, does expect modeling just mentioned what look for just of like? say we I significant can press this point NRDL? is purposes, you at for what So Thanks. kind think increase, discount the the

is Yes, month. then it's so $X,XXX pricing month. a $XXX the for QINLOCK And NRDL NUZYRA, for a

Okay.

will the Oh, be sorry treatment, for it for $XXX treatment million costs. the $XXX the for NUZYRA, --

Thanks. great. Okay,

for your Thank you question.

Jonathan stand Securities. the ahead. Chang The question. now next by. Please are go next SVB We question Please from from taking

Your open. line is

guys. Hi, taking Thanks my questions. for

how just second and of then the of question profitability of of Zai situation can question, and compliance can about corporate current more going underlying Lab's achieving in state thinking discuss forward? you you. HFCAA the your assumptions your discuss elaborate by to, confidence you with First the this? level XXXX end Thank you're on guidance And

Yes, thanks, Jonathan.

got So second can two. maybe I And I make. quick start these to I'll that's a the with take to that point be want one,

with are seen that And would U.S. that that's the the all that And you now five is from that we sort have and have with the And all any So kind are list by result, filed for PCAOB requirements HFCAA. fully we future potential that the [ph]. have now continue preclude just KPMG going from the of our kind us and to that fully delisting we to to as things we means accessible XX-K compliant of of be any a NASDAQ. of or believe

the So very important proud of hard team this us. very worked it was for that strategically to get done. And

think, I team again, U.S So board. a welcoming the to KPMG little kudos and on

we question, wouldn't overall about of unless we've first statements, such of on Jonathan, to your an feel getting to profitability it. So by end carefully that do how make kind 'XX? we thought about the statement we made about

took heavy hard Jonathan, or XXXX, -- way Street, so I if you of a several kind years, you the of assume since able assumptions infrastructure done have profit, of just and to going G&A, and sales, improve then by already over gross you there, your give you But not about especially best number spend the think we of that time, going you giving that, there's you lot today's to and the be And that. with stick assume So would use modest and that. range will the had we're even continue guidance take on numbers. we're whether not to at then lifting you to you but a you this for the know, but marketing, that's next -- whether sort kind out if to get

you about public And that. it. -- think confidence that to good So pretty gives comment make us I the about we should a feel

it. Got Thank you.

your for question. you Thank

from by. next Please Chen Ziyi We are stand GS. question the go Please now ahead. question. next The taking from

Your line open. is

Thank you my for taking you. Thank questions.

The more [indiscernible] looking year, next expected margetuximab, launched and first we're with in drugs or question is, be if commercial to and antibiotics. including at XXXX eGFR infrastructure, the more

indication compared set in we're productivity data. for bigger to course, the to mentioned elaborate what covering Thank you're bit So LUNAR to to And [indiscernible] the team the and you. understand achieve be more potentially since variety about Optune, efficiency of could of Trying little bit the based the and about the in secondly, you data areas. communicate timetable the what becoming more is could a on of is maintain planning to terms potential a pathway, plan in when China China. about, going also different [indiscernible] forward commercialization But order and to much and, of looking [indiscernible] up you therapeutic category what your now. sales to a therapeutic in

thanks, And who your you thoughtful are question, give about as portfolio Rafael. a second we've I'll question Zai Yes, story with pretty Ziyi. familiar curating knows, first Lab people to your us. within quite On been clustered they're all of -- specific and terms potential. that's areas in are quite are large that for very the differentiated some of the around know some strategic programs And that, commercial of

likes Fields adagrasib the Tumor based data blockbusters So franchise, program. Treating LUNAR, the as would for a potential of the bemarituzumab, be on pipeline

KarXT people that under et under cetera. appreciating also are estimating think I drugs like

one. point So that's

on. see There's right lot three currently in the look already not you those, of look if a quarter, NDA that programs have submissions, two we going effect at Point actually at you and quarter, mentioned -- you clustering we have in at you've now. if a of will and it. the pivotal two also some snapshot quarter, stage look But is it's a what of a you

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of or to course, Fields, and programs of a got ROSX, just the which stuff. LUNAR, LUNAR, the the specialized one got we then you Treating the have Tumor And would force often from sales KRAZATI, anyways, at -- lung long for in missing look And course, itself more. two probably in benefits a and near-term you've addition the

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Rafael. is This

of PMA question. over to briefly, NovoCure equivalent the And has on application to of expect submit that's FDA, year, with they by pre -- want to just drugs. that of for second part the Just the end the public U.S or -- NDA which of wanted the the made second this a go the approval market half

So our U.S and plan the follow is [indiscernible] in submission [indiscernible] submission to on submit the China. following

we submission will accelerate the the in PDUFA we the we timing timing then authorities to submission. China. to our U.S., of work try closely as but obviously, U.S the the the with the of as work soon [indiscernible] timeline follow approval But And possible. in no very as So with there's exact for partner

expect distant be the be not approved we after future, in will file and the the U.S potentially file. imminent too So that this could

Thank you. Got it.

you question. your Thank for

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question. Great. Thanks for the

then just the the And how a opportunity of Billy, just question, quick really So to what effectively you maximize approach market Treating through important. just Can is to spend think stated particular promote second just that questions. that -- a you us you team understand be opportunity, the And of obviously about going perspective, think to this I as manufacturing two we if you help from to us opportunity that Tumor KarXT size going support program is opportunity? this potential think KarXT Thanks. perspective? is Can kind again, Fields necessary opportunity you quick to could that just see SG&A appreciated. you're manufacturing from do you you how specifically walk evolving? under feel

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today. on than are people are more even million we that monotherapy, potential And you're potential believe it's or a China question did that symptom in to people domain believe KarXT, multiple and got your this the underestimating I in schizophrenia in treat we there with X think -- we And living China right. say the adjunctive. For product. as

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