ZLAB - Earnings call transcript Q2 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Zai Lab's First Half 2020 Financial Results and Corporate Progress Update Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Mr. Billy Cho, Chief Financial Officer of Zai Lab. Thank you. sir. ahead, go Please

Billy Cho

providing Good financial welcome conference results Zai six press this operator. financial the first for results call. Zai half morning, the release a issued XXXX and ended Lab details morning, you, of be to company's June and the Samantha months Lab's Earlier at the Thank as corporate of the section Zai well as The ir.zailaboratory.com. XXXX, Chair Chief Relations call corporate updates. Person Dr. press Executive corporate Investor website led release Lab's Founder, XX, Officer. recent is Du, Today's will update available by in and company's

Wang, We relevant who of of also will of available by during will answer Tao pipeline, each Business joined lead will us are details questions be to take more President questions remotely, Q&A Jonathan the on on and our as be and of and Head the the Officer, call. because provide will milestones to including needed. Development, Samantha executives Chief Operating dialed-in majority upcoming And Fu, the portion refer progress. commercial

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

Samantha Du

and you, Thank Billy. all us. you thank Hello, for everyone, joining

investors headwinds pandemic, We hope ones the define by truly the everyone the brought Despite are world through and continue loved on and Zai safe I to build healthy. strong COVID-XX have their leadership we Lab's execution. and across so

many provide We full us. you to our update the have call. also what excited achieved outline milestones earnings with We're a since holds and future last for

NDAs China; CTAs in stage across development accomplishments eight NMPA which successful XX business include: XXXX launches in platform, highly approvals assets. strategic key deals; commercial accepted Our three to two priority broad an trials with now clinical reviews, includes Optune; two our date initiative XX and for approved

able overcome from XX. under Optune you was on support of approval, patients immediate June headwinds and weeks January to China see, instant ZEJULA given number late As gaining patients can six we needs. COIVD-XX the both medical available be and which in from Optune and launch in the launching from to ZEJULA, medical with pandemic, were communities the regulatory payer

two highly of opportunity late-stage is highly Repotrectinib our a to of existing remain pipeline. Repotrectinib. drive wave next to company, our area that confident hematological pipeline, broad [ph]. allows leveraging strengthened our further differentiated biopharma Lab our With area continues Our with capabilities transformative REGNXXXX Lab differentiated We therapeutic leading we lung Zai addition network exciting global clinical the cancer synergistic an and REGNXXXX spend disease to cancer pipeline become with assets, the with with and impact. and Zai stronghold. innovations can establish the

and US four two consists two diseases. rights commercial clinical pivotal clinical across infectious and advance internal stream the launches partnerships, approved launched areas, three with programs discovered across stage late-stage the autoimmune our clinic; oncology, our pipeline planned nine of FDA XX in global Greater approvals the plan with development; in China China; approved assets years, in assets and over global have internally with portfolio establish to into steady Over XX trials, of ongoing we therapeutic next multiple and a stage. transformative Today,

Looking potential why to we'll pioneer in of our biotech New as strong continue for and Optune our as to China, a XXXX our and execution years; and is becoming our team, expect next global This momentum I to look the and propel three exceptional leading product we or of business And that reputation development the choice through the did first-in-class and assets clinical start opportunities. for ZEJULA the forward remain and to key proud of global late-stage and end China. in platform, bring into strategy preparing execute other strategy transformational partner expedite we to a deliver for Year, commercial approval, bolt-on assets launches, in in growth. Zai of regions We're company. our best-in-class believe continue additional can we readouts development for confident a reach biopharma deliver very to

becoming also in state a We significant XXXX Mainland commercial in China. milestone a reached by company

commercial for great a both start. off ZEJULA and Our underway launches and Optune are to

opportunity still on to China, for comment both and early in the it's we believe is launch ZEJULA there While significant assets. for trajectory Optune commercial

for cycle our aggressively also with continue footprint. They Novocure in products Importantly, our management global we're and we capital life expand closely human to both indications. and traditional are and and partners, excited strengthen GSK about working opportunities expand

choice, for this we speaks and engaged confident Lab, itself. record globally, XXXX, and employees, XX, global our with of goal, mission we execution to across levels all leading and talent a grow attract commercial employees firm. have am to different continue I the scale. exciting for is a I It that XXX believe XXX strategic required with to the experience and top pleased say, our We June continue our Zai across successfully activities, seven is XXX on had resources very in time and am one and track reach R&D to offices and regions respectively. is we'll in biotechs of employee As the

As catheters. I upcoming COO, to always, Tao With all keeping support. over updated We now call for said, like continued your you to interest our Tao? Fu. and we of turn to look President that thank our you and with the forward would

Tao Fu

you, Thank Samantha.

As for XXXX Samantha exciting across variety period Zai mentioned, Lab and been of productive a a has year-to-date fronts.

strengthening therapy. We hematological of continue disease to new build with ZEJULA organization solid the within stronghold therapeutic momentum two Optune. of our establishing with area development executed launches the deals, strategic successful a best-in-class targeted tumor We commercial business the and potential and addition our cancer highly

commercial balance enable sheet global strengthened important of to therapies to Zai bring and our to significantly our our many talent, patients. In China R&D Lab the recruitment expanded further addition, organization and we team top-level more through

of While in we'll to provides today any our start or I'd our questions focus That be press my session not updates comments assets our during niraparib answer across that and programs, or prepared detailed morning with a release remarks. most like to I'll the any happy ZEJULA. catalysts. few Q&A said, selected on from this covered near-term programs are

for in approved best-in-class PARP believe patients ovarian tumor globally in of maintenance indications. Our is for monotherapy the PARP first-line States inhibitor inhibitor and other treatment a approved only is development the it for the We recurrent several inhibitor, all-comer United the given of PARP potential in settings. cancer ZEJULA treatment solid and

to including dosing, the cross pharmacological properties, low In ability addition, interactions brain and it once-daily drug-drug barrier. blood bank superior has

China was know, over launched in the of you XXX launch. of ZEJULA second-line for cancer hospitals ovarian at As January patients treatment in maintenance covered with time

one six therapies and cities. speed, also on-site launch online. Since As to commercial with winning and Zai ZEJULA listed patients. done events held been has province and launch, earlier, insurances this both reimbursement in included execution underscoring incredible noted capability in Samantha with commercial Lab's provincial level has been launch customized regional important and was XX the commercial It health four in municipal for insurance,

expanding our In to Zai commercial for addition launch, ZEJULA. on executing to opportunity the continues on focus

from sNDA a both HRD ovarian currently maintenance PRIMA results the that submission statistically NMPA. based first-line on significant in patients clinical review In study, under cancer in Chinese III priority May, which clinical subgroups Our the confirmed therapy negative the ovarian results The women clinical ZEJULA was patients cancer. results maintenance from NORA the a of top the as consistent as ZEJULA and line seen ZEJULA Chinese and the profile recurrent HRD positive and patients positive This the is treatment experienced of compelling study. demonstrated the by platinum-sensitive, for Zai benefit. in Phase study with with data global announced meaningful for NEURO were for

ovarian underscore that cancer individualized patients. toxicities, of XXX demonstrated These to results at efficacy dose including while ZEJULA an starting the with NORA in the of Chinese a safety the hematological regimen anemia. as best-in-class reduction further the profile regard study improved promise milligrams, treatment. and Particularly thrombocytopenia Importantly, preserved

this Looking as ahead, cancer. as continue NMPA in fields. the the to to patients marketing many Tumor our has ovarian with of treatment years medical also treatment the recurrent first in and therapeutic GBM. clinical diagnosed XX innovative need first device is newly of as China. China for monotherapy GBM. without over in a trial the Optune innovative China ZEJULA to combination beyond And patients It is a for plan and with by NMPA treatment with the including temozolomide approved the medicine in approved possible, develop patients benefit application GBM approved Treating to the authorization of in for tumors bring for

China's X Level Glioma newly diagnosed Guideline, fields recognizing treatment Treating its patients is Tumor evidence effect. Treatment Importantly, GBM in with breakthrough for recommended

XXXX. addition, recently MAA half Kong in of to treatment In launched Midcon malignant we the file in Flora Hong and in for China the expect Optune of the first LUA

will lung While expansion next in given mesothelioma non-small approval and is is cancer. be potential strategic not China, synergistic a us cell in the opportunity very indication large for label the

in Novocure non-small interim Phase to from expect its LUNAR announce cancer results lung Speaking III to that, cell in XXXX. trial

gastric incidence have also is according of patients, give National To sense II diagnosed Statistics. clinical the pilot for XXX,XXX China in the a gastric Cancer first-line lung potential over are in XXXX and these an label expansions, enrolling market and rate to respectively, trial you potential which cancer, cancer Phase XXX,XXX cancer annual ongoing well. We for

Ripretinib. to on Now

with through this product advance important refractory for towards finally, those It approval Phase antibody for of forward review an registrational diagnosed filing Point Deciphera. Ripretinib unmet Regeneron's to we Our with has the and to XXXX, who investigational NMPA spectrum fourth-line II partnerships all-comer their stromal This approval, Ripretinib and are and innovative being or Deciphera proprietary potential a promising this full approval. to bispecific gastrointestinal treatment QINLOCK CDXX believe therapies, targets Chinese And as priority inhibitor medicine. lymphoma of closely or B-cell mutations trials, KIT therapy our support of NDA every setting. GIST for and alter China advanced discovered is on global CDX our NHL, to GIST platform. granted review. the approval drive of XX,XXX PDGFR-alpha treatment broad that licensed a and Regeneron such oncology potentially especially Chinese REGNXXXX, look for Since pipeline will the treatment NMPA patients with year. announced to control accelerating diffuse PDGFR-alpha as of granting update to kinase from most patients, of enrollment landscape for May Regeneron's collaboration bispecific in large prior priority switch the KIT known respectively. with working over FDA follicular in in development need the the an the Turning lymphoma GIST. trials. is potential strategic FDA magnitude In the tumors developed GIST therapeutics, significant, underscores The into patients We is accepted agency patients and ripretinib

Cho, We treatment as and development medicines REGNXXXX was innovative an about the Regeneron, and recently, the excited granted of with immuno-oncology exclusive Zai a for leader research in are partner standard the ROSX NHL to Phase advanced Billy? all More patients patients. of non-small Zai Billy China approved, next-generation TKI-naïve our thrilled commercialize off-the-shelf designed the of II the global potential to to clinical financial Greater inhibitor care cancer who to Chief sites opportunity. candidate it hand Officer, mutations. to positive potential has opening China. Lab In and early to our additional effectively lead investigational TKI-pretreated anticipated cell of studies. provide is best-in-class for call untracked Financial tyrosine rights X% target that, both With I will patients. significant If lung overview in of will potential registrational an develop Turning demonstrated trials, ROSX and drug Point's X% of efficacy repo in commercial an highlights. patients. About clinical Repotrectinib, Repo for kinase be or the in Lab over

Billy Cho

million the and increased period efforts was to sales million research milestone and XX, expenses payroll-related sales half increase headcount to clinical period XXXX. the Revenues for period results were attributable same for for Optune R&D of $XX.X were given were internal in primarily in from The late-stage commercially to Optune, in in due million ZEJULA's $X.X increased the newly of comprised period support China. expansion ZEJULA the ended expense expenses June I’ll ongoing the primarily in related and $XX.X payroll upfront fees same of for and in Selling, costs compared at the compared XXXX, main XXXX. and $XX.X driver was R&D period development for Thanks, Tao. commercial and $X.X January in increase revenue Zai in for its of The that increased of payroll same general XXXX, June. made compared $XX.X Revenues review now of China as Lab expenses to to million payments, from payroll-related $X.X commercial the end in million expanded $XX.X administrative respectively. China headcount Mainland for connection period, in Launched expenses and was operations our with period over for was initiated XXXX. and the six-month financial XXXX. to the available in first million the the were R&D programs. million million trials,

of of holders net Lab loss million, six net or share a the in ended common to stockholders the period For million, common XX, months of loss at of to same reported net $X.XX, net share or XXXX, $X.XX attributed loss $XXX.X $XX.X attributable June to Zai compared per a stock per XXXX. a loss

$XXX.X operator. cash like now turn As restricted We XX, totaled XXXX, of June cash the equivalents, call to investments would and million. to and back cash the short-term over

take operator. can So go ahead your we and questions

Operator

a question gentlemen, from we question-and-answer line Ladies begin the [Operator comes Yigal Group. ask Instructions] question. you. session. first from and Citi now of Thank the will Our Please

Yigal Nochomovitz

hospitals? sense question. I few you ovarian much of questions are in ZEJULA the ZEJULA? then could uptick you very early from to on but thanks evidence hospitals, any which comment sales And are the doctors to Lynparza are market And addition days, luanch. urban seeing the in first-line switching as off-label for patients the can to its you you have that Hi, And I the seeing in you know of seeing at to cancer? regional early extent taking you had share any in cancer? a second-line all to ZEJULA ovarian early provide

Samantha Du

your Thank first. you, Yigal. Good morning. And let one me last answer

First of all, we sales. never do off-label

mentioned, probably the even and we for by I are patient, Secondly, also And self-pay. launch the we trajectory product market and already it's about very early the into the mentioned, under how the currently myself optimistic received we're penetrate and still still the as the see though very, deeply – medical being to community. has you how Tao ZEJULA know,

work and with different regional with also, we the So on And the insurance we focus different KOLs, that government. very self-pay, on much PIs. on groups

But patients. penetration direct first – as you cover list of though launch. there of And only And the compared to two the the usually, six of penetration times and in have a some good we we color, the go to first hospital terms the and product. four can that, into hospital some like for So have give deep even to know, it's only seen go enjoyed are have in you, even launch, coverage payer. you quarters to months have of we – things we sectors. for hospital we very And we competitors, IMS the private very with

that some been have on doing. hope And we how gives color so I you

Yigal Nochomovitz

Okay.

Samantha Du

question you tiers a asked on cities. different think of You also – I

with even we around payer, we sales we far, somewhere first do actually reps, cover existing started year, the cover so though And hospitals. we with XXX private many And hospitals. cover we

Yigal Nochomovitz

evidence not early at switching you ZEJULA, that's point? Any or to glean Okay. Lynparza of from information can this

Samantha Du

but first-line some we trajectory. are And very the too have to all-comer have forward, a early strong first-line only the I have – now where looking we very we'll we And future. we also optimistic it’s approval. think – right tell, have it's fact about still

Yigal Nochomovitz

the Okay. And just on a then question first-line.

review. have expecting decision the from you are priority When you that So NMPA? the

Samantha Du

good We review as you accepted. know, And received question. it after date. not priority does and was we the That's soon PDUFA a have filed, China a

Yigal Nochomovitz

Yes.

Samantha Du

give on you I color some can But own our experience.

which hoping we For were a we second-line we again, PDUFA is from been half was are of regulatory to this course, emphasize first no within year. to results as everything in product ovarian cancer, is want date. are into much we But able knowledge. the haven't get seen for, to way terms difference And our usual, approval there's of XXXX. looking March, that I since approvals, first-line This accepted looking in

Yigal Nochomovitz

which Okay. Thank haven't dosing just release very when in on Phase you. have quickly talked about Hello? recently and you we any program from in the And studies? pipeline, much, started ZL-XXXX sense to could two first press said ZL-XXXX. very your proprietary then Do for you we those X the as you see the that data

Samantha Du

Yigal. I sorry, muted. Oh, you, Thank

Yigal Nochomovitz

Okay.

Samantha Du

As the we concrete just have started will you as clear, the to we this data, more And patient mentioned recruitment appropriate. as market we update year.

Yigal Nochomovitz

Thanks Samantha. taking questions. Thanks, for the Okay.

Samantha Du

Thank you, Yigal.

Operator

you. Thank

question Please Morgan. from ask question from Rama the J.P. line Anupam your Next comes of

Anupam Rama

progress. much so question. Thanks And congrats all for guys. Hi, the taking on the

you prescribers seeing prescribing? Optune give and a are and can launch, ZEJULA the of much. each so For in of seeing sense Thanks terms what of products you terms in repeat us of unique you for are what

Samantha Du

of great will all line let that's And on morning. top some first Yigal now question. you Tao give answer to I And – Anupam a good that.

Tao Fu

question. thanks for Anupam Yes the

on early We start. off has mentioned, detailed the to what launch feel really repeat too really in start bit little really versus middle information of user. dual great from a in record keep give we But this need pandemic. think Samantha speed been to approval I the in mind; launch still done is to it's new as the a you

So implementing really done the our has team job terms of a in programs. launch great

We very tracking really been that pharmacological very well compelling product have metrics the have Overall, very indicated, a received superior and clinical the has Samanta demonstrating is on also profiles, China-only dose safety as of events both of the you know we we Chinese is recently a from reduction track product the and profiles the the the treatment has safety global And few efficacy well. oral everything the study individual product very study, to profile an latch study. potentially which with of data as completed large patients. preserving into we They by strong important physicians. starting

of these factors strong play all very believe, momentum. launch a should great into, a and we So

Anupam Rama

Great. taking Thanks question. our for

Tao Fu

Thank you.

Samantha Du

You're welcome.

Operator

Thank you.

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

Jonathan Chang

for guys. congrats progress. my Thanks on questions Hi taking and the

can Mainland question, broke us First the half down give sense versus by China? Hong a you how of Kong sales first

Samantha Du

good Jonathan, morning.

let quarters whole say have the of group two you regional product, given Hong have of the First revenue good us We contributed all of at if actually look majority very And since currently product. have have half to list Mainland would overall year, we we me very by breakdown the launched say – And China, first momentum. we in from first is a Kong. strong China. I a good not do actually very, since we

Jonathan Chang

towards would a platforms focus you we potential half approaches? second where focus? certain could thinking deals outside the and you. And you. expect existing development or areas be to and have XXXX? these Got in should Thank it. just opportunities of business indications you how in these on already question, additional of bias And your have be about the second Would indications you presence, Thank year

Samantha Du

a great is question Jonathan. That

I our turn way I think because that asked Jonathan, to BD. like can the Head the of I table you

we him know right? don't All of harder, Jonathan? he So how us both, hard work make can. can even can I although

Jonathan Wang

Thanks, Samantha. And thanks Jonathan for question. the

And but inbound reputable a not business the strategic this years these lot really over for that very to say a accelerate for a development to we are really do also western from, deal Chinese in the access good, them most last built to is actually, companies. currently interests looking world. robust of market the choice pipeline – pun for backlog. the have a them at And the help, also to their part of of strong by quickly, me And Let way, as it few first have U.S. Zai, objective a help we the global companies comes them of when only development. reputation

we specifically good have of the very Now first had half. terms in second I think, a half,

done a also products two very strategic those one We Point, China potentially assets, categories. arguably, late-stage from in working hard And expedite we with development work in one their both and perspective. them both have Regeneron, deals, with with best-in-class great Turning are to timelines global

us I or hard. uphold infectious can, out first-in-class I'm that to into So areas, what going from sure you also best-in-class we areas, not all, good the future. have several rule that deals globally But very working diseases Regeneron assets, we especially where keep always we And that half high we forward, more disease the into commit the I immune adjacencies going think, we’ll is in obviously of have first indications, bring to same near in tumors but this just going to very year, building won't Hemonc second bar I a with expect have strongholds. would We we're deal. oncology or priority solid think oncology lot areas quality think where like number we a our of done potentially are other

Jonathan Chang

Got it. questions. the Thanks for taking

Operator

Thank you.

comes Our Please next line from Jefferies. the go Raycroft Maury ahead. from question of

Maury Raycroft

my progress. everyone. on taking all questions. for Thanks Hi, the good morning, And congrats

LUNAR with to going And data about timing of are XXXX? you guess, there to data? particular that NovoCure's I on what have why prior the for talk First first it filing expecting one reason you're in I you is any anything now happen in MAA, the Does can XXXX? was of LUNAR just in be on the Optune so think, MAA guidance for the XXXX. do to half more looking

Samantha Du

bridging very progress the I is started And next estimation. second indication actually we we and of consistent pretty of and the making actually with This Optune are filing the our also, underway. And we already and in small, this approval the though timeline. relatively Jonathan very of this This our strategically, is solid there's even optimistic be – impact, like And but of the remain course, tumor terms first tumor is think, we And is in of in half think and mentioned, important. First be terms first would – good to we year. trials. all, approved. on anticipate very material solid

Maury Raycroft

That's anti-infectives to helpful. these for about there's And just for the and it. that X of study? if X, sense that design study wondering China – Got timing then Phase from newfound the the design Durlobactam a programs, approved. for could if you I'm then talk urgency more of get for regulators Phase And

Samantha Du

for first has news review, was release, First market ever priority use And say, review as on our for that of I from priority was Omadacycline, open drug and and this China all, on resistance review. been the saw you one since to have put May. antibacterial in priority

projection, bacteria the closer, we resistance, will them a no we market. closely just agency again, work terms to mentioned, a in with the important As medical lot report not There's about of needs. China, and of area. And a as important we optimistic work date, we approval. getting get this very has of China And detailed, timeline, really feel it's when but the you wise unmet we in it’s to you give product. us Especially with for this approval closely PDUFA on

during the haven’t seen second plan. would overall patients we trial program, In this you to we because we done recruited have our the terms because global we can partner patient is with the asked disruption. cover discloser. The we of joined how to in and – though our great we and have rely recruitment, global question, Thank color give And terms is more right? we you work and on we any this had program, China, design, to of according timeline cases we – Maury. COVID, a in But current about trial gram-negative also even the partner job, on on – our would that their prefer you, and on patient

Maury Raycroft

for very taking Thank it. questions. you much my Got

Operator

Thank you.

Our of next ahead. Please question comes from Seamus from Guggenheim. go the Fernandez line

Seamus Fernandez

the for Thanks question. Great.

just could just on could was focused sense on, if are give us are your collaboration a data particular, catalysts that hoping with you MacroGenics? here. if of focused us I that And of think So help just separate CDXX you you characteristics any in Thanks. then where you Samantha an give most a few in the update most in therapy? differentiating potential a can introduce that you question as are novel worth thinking how us your you as just China about understand And landscape you are antibody you noting?

Samantha Du

clear one questions. we for internal Seamus let last And you, see me first. Thank Sure. extensive from our the answer And a these work. CDXX differentiation excellent CDXX, have done preclinical We work.

more confident. lot far, so we're program – more forward. CDXX under Having get move And the also clinical the a the is opportunity have of us we to differentiation justifies. of for when as and data I we existing to with think really clinical seven close justified so has And we still stage And what and can combo our this and information, the our doing partner, know that to we're margetuximab get said question back sure also to the more I least, based We provide having we other none very CDXX at pipeline. understand while synergy – also our combo And been getting seen with we Secondly, development. we're we – approved. there's will – change believe, and focus but this on will information. and Jonathan going on are so what the – publication, leave you And would I'm cover. if also

Jonathan Wang

our Yes. the Seamus, on collaboration. I focus with the think MacroGenics question

cancer also that. As they that in have data global you a with as the disclosed margetuximab in saw, China that trial ASCO we in for ago, to trials, they a But the LAG-X with of large at us. is months very for couple such not gastric the advanced of is were a but monotherapy data indication promising, at early hold only the that the that, addition that but XXX three PD-X in I as and the gastric very responses. for such trial, that we while combination assets promising, the And triple-negative that observed are et setting, DLBCL, which margetuximab, data we I normally cancer being you in are that respond started patient Obviously, we know, PD-Xs, various in seeing don't collaboration. seeing in we cetera, licensed cancer, together with that being responses HERX there and very have populations most case, think to PD-LX focus breast trial lot a earlier think expressing in with as promising MacroGenics,

So a very positive be important MacroGenics. although and with think also early, that focus our collaboration for I very us it's in will but

Seamus Fernandez

just in of think to your China. And I the pipeline? starting up finally, PD-X, maybe follow- part Great. Any as and capabilities, COVID some the thoughts maybe anybody's And CDXX. your development then question We're – development the don't asked see to or of CDXX CoV-X CDXX emerge in bispecifics about internal own bispecific. a also terms sort bispecifics of are dynamics

sales on you – get reps ground to Just of in as experience field. the deploy the an in the wanted your update terms

seeing so a opportunity collaborations. ability to Thanks the it in the be research be your more just as queue. seem And unique might with China, to jump that markets perhaps related in studies to much. recruit would what continue versus I’ll back like to successfully than we clinical other well that drive As affected that's appear

Samantha Du

ahead. go Please

Operator

you. Thank

Goldman next go Sachs. comes from question Our Chen Please ahead. from Ziyi

Samantha Du

Amber, do first? me Seamus you question to answer want

Operator

go Please ahead.

Samantha Du

Okay.

to happily the old since – clear infected business. you given we deal have the and about think especially we Zai and always a done still program. also you this really I have existing – been that will appreciate we our CDXX have at we've safety And discovery, taken may has regulatory talk the our our should of – people our program some very focused doing they been – have potential and who CDXX program. aggressively, as also with also through though and employees move stage, report, with combo fortunate none procedure gave the I and have difficult bispecific. may itself this have place COVID-XX, still company, have we occur. have first see commercial I we recruitment, closely In of this learn our we I very in in far, cannot been to From we early of when what trials, and the work to credit to point been secondly, and very, a – and limited our it's And – so we will talk to earlier, of maintained from – justified has let's when we about comments I you very all, But say, how execution situation So from time. But really, the but that opportunity, any – how are lot very forward. limited far. and but in speak from we Seamus, and Lab, confirm, impact patient announcements understand work globally combo bispecifics, even too terms with. approvals, to to however, we see impact affected. – as outstanding. But And when measures for knowing from can releases good companies. team think experienced also, announcement program other clinic your and able I and launches, – I to potential this so said appreciation, very it's impact as we opportunities we've about the we by on clinical And evolve CDXX in we we And PD-X

funding the have In to impact defensive. we say of quite launch, business to be the we are ZEJULA terms of

not are target. changes making revenue We yet to XXXX our

it's such also measures, after team programs, days ZEJULA. helped And immediate We getting team's municipal are major – off launch and And – we execution, especially, It's ZEJULA as excellent still commercial insurances. in taking approval. been online at a very very launch the itself fact optimistic patient over deliverabilities, on team's launch major the I and able XX think we're that physician, list have confident course, before terms to by still levels the record maximizing quarter first the the start. breakout really, we our education on event this And the the good help and execution. on creating by for of of and challenges commercial provincial, our also consulting our a really was reimbursement

I So hope Seamus, your appreciate I answered and really your question, time.

Operator

Thank you.

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

Ziyi Chen

actually quarter. is from I Thank Ziyi the two Goldman. got you. on questions. second This Congratulations

we second an negotiation know actually reimbursement national on in November. ZEJULA, the probably there's to because list that be first upcoming like October, going half, The

reimbursement to really – is penetration. penetration, pricing think a penetrated already XXX market hospital We're we how launched and towards already without what the for means ZEJULA? six like deep about potential cuts? getting the reimbursement, Or And national should That more trade-off just we we national months. like particularly, So for about a of pricing into strategy the got list hospitals.

get we're So kind do the actually guys into – my that's second, need going for – innovative or first really to get can devices. a question. hospital So the for of commercial this we a the trying you – or its can probably we I'm just model. sense another is for the coverage year, commercial medical strategy in to reimbursement better wait like year? say And to of Optune, first national first Because better

have So if device treatment to itself. paying purchase or the actually, for actually for the patient the is they paying

cell the potential commercial non-small – see we the program, we a look helped into the – health at follow-up how sense get among that better I'm – cancer strategy. put on also we of trying small actually those and PD-X – is the of And patients. that? to lung initiate start So clinical acceleration adoption development to that a insurance

small the also in really China and a been non-small on lung potentially approval, are cell given working crowded, have more cancer commercial So PD-X who there few indication. – cell lung are near this several in the space

in other or you. we're smaller trying Thank still of indication to indication? enter looking still this is why why Zai a instead the – Lab more So differentiated at some but Samantha? of

Samantha Du

But I Yes. Thank for thank all, muted. you. first of those questions. you was

NRDL, covered whether five say, team and to XXX done a job hospitals on terms has for you I they need reps. with of wonderful as put have In to only months sales to XXX be the the of said, launch. already first We XXX ZEJULA,

pulling upside. will top gave However, the volume only third reimbursement not in on overall us and penetrate we cities, will further the – the opportunity fourth so tremendously dates with really actually, but The you to November, started tier reimbursement – two China terms and – of believe rest a they the And improve revenue our the to tiers. top coverage definitely agency and up with we said, price. the of applications, as in and will and very already – come welcome was when work to interested for asking reasonable be and

our calculation only for understand We have China. local as good pharmaeconomics, in are we local first-line And also competitor. to a and company also of and the one ZEJULA ZEJULA, – from for is and understanding, category for we compared monotherapy one the and only

many of we think to have with with reimbursement minded – advantages, have at many point, our the opportunities many be a up this really to the agency. strategy. work a to I And on work no. – we talk with agencies we goal have very with – would them. come and and the announced we – lot room wouldn't – least have and is to say we to right reasonable And come I And at So pricing. up so to – about open

China. In the patients top all, have that. Tao Optune; as and of are I first the And say – you the Category further X is question to I'll And into bring let I on treatment elaborate device. said, you give the about buying this and first of terms to only option line, a now

elaborate so you Tao, on that want And to point?

Tao Fu

Thank Samantha. right? around clarify. program PD-X to want Yes. I to indication, cancer cell question and you, lung want is non-small just our just your clarify I

Samantha Du

That’s the third question, Tao. That’s just…

Ziyi Chen

PD-X. and also Yes,

Tao Fu

Okay.

first. So let on comment the Optune me

innovative GBM without is years. in China is a is approved trial. So as over the the the treatment clinical last first that And need Optune also it by you for a device XX first for know, medical NMPA the approved

excitement considerable about is launch So really this product. with the

a high awareness and We very, very the have sell-pay by medical community. very strong opportunity. believe support there We is

far to so I launch, really start. has since our been off good a And launch think

I probably comment that's Optune. the top So can make line on that

market We hospitals majority top very the the for GBM of because concentrated pretty XXX have strategy really is comprise targeted opportunity. a the China, of the in market

very force, with our a sales our targeted have strategy for customers. So we

Billy Cho

not why treatment level, There's clinical that in reason a question. call And a part at here. behaves Yes. a say, a Ziyi, may or well I device level. your of we, way chime as because strategic partner, as therapeutic, a our that was I do at think this Novocure, really a if And also practical and it

right U.S. is the, preposition is believe, price nevertheless, modest over a the list as the I premium in it a So therapeutic. to a China It now, But bit US$XX,XXX in discount list US$XX,XXX. price is a little

GBM is release US$XX,XXX latest price, patients PAP, offered global net our which the in believe around post going number that for to down, and earnings I to based a be partner. Now on from average is Mainland it the discount comes China modest at

so is So – payment monthly with transistor the all-inclusive that included; element. rays, so the backup, payment the that comes comes hotline in the service everything and the an device, in,

So it a for behave way in paid ways you the really way behave in really it's are and many it, the does like administered. the – does in in prescribed way you therapeutic. It

that hope I So helps.

Ziyi Chen

Got it. you, Thank Billy

Samantha Du

Yes.

China's PD-X. on cancer. contribute our in we back Incyte, partner portion with we in And coming approval. which we together participate of And relevant of endometrial – second all, So participating the the global the is first are for process line

very very of by cell – and much our with a partner and And we with have market opportunity efficacy, globally. working China patients and the we only safety very to is also China's option. needed think very treatment contribute economically. justified with to PD the landscape differentiated the good PD-X – bring having we also and already. lung PD-X so portion way approval, it's a competitive of relevant the huge non-small and think agree cancer, said in you, the a terms terms with – this it's in very a I In And I But

Ziyi Chen

Thank it. and much, so well. And thank Samantha. you much as for you. Billy so Got you Tao Thank

Samantha Du

welcome. You’re

Operator

you. Thank

from Please Suisse. ahead. comes Credit line go question the Fei next Our from Zheng of

Fei Zheng

commercialization. we slow breakdown the the sales or for Hi. Hong from Hong only a overall may for second the some Mainland some readouts. just overall those we Since also Kong data And rate, first This My for – the our and haven't about ask and And similar question. – Lynparza that are ZEJULA. majority have some of for is competitors about Kong? the internal I Recently, my the we the the about – if is is Thanks Optune. Is my has If when data? our from sales not, going I'm is grow Fei. mainly taking is sales data. survival do at just wondering reviewed survival I to that reactively sales question clinical pipeline, third question Hong My about my China Kong, found the sorry see China? slow from from question ZEJULA, is Mainland CDXX.

questions. once X the So are Phase to three going license study, differentiating from complete I be safety think the side? have Is the global And some or factors. this mentioned my we out Thanks. side for opportunities push Samantha we to product? from mainly also, looking the this trial efficacy some That's that we for

Samantha Du

Thank I you. your question? second Can clarify

Fei Zheng

the have And to benefit. a overall have – Yes. the overall survival wondering, BRCA-mutant of does in seen such are question very survival because they going settings. survival. ASCO, data overall the those And we long not, If data reviewed recently placebo, when the they ZEJULA Lynparza data? My is about similar I have see compared I'm second ZEJULA the extension a the with

Samantha Du

your Thank question. for you

this Let me first. answer

efficacy subgroups – – particularly have – for more have month, PRIMA, all – about you GSK's length? the during And of may global for they for in amazing they and and gBRCA. the negative. Jonathan, category, we comment the do HRD of study and to gBRCA, each also positive have And achieved actually, – accurately very I First we want

Jonathan Wang

Yes.

the they first-line HRD not it's comparable in the month negative definitely to can't obviously – setting, be also in setting. just had HRD to efficacy, remember but positive, I only exact and BRCA think strong the positives. positive, in BRCA the very the positive for Actually, I

Samantha Du

not Yes. or if impression months, I par under at we that confirm was least number. in I anywhere are XX are definitely, to but better, – XX need with we And Lynparza. around the

China? so So the to back go we question question, right? about listed Kong, that knowledge To that's Hong my ZEJULA, Is you far. launch first right

Fei Zheng

Yes. Yes.

Samantha Du

as think strong Kong, momentum. I in done I have continuously remain mentioned, great we job a Hong

population versus X.X However, Hong billion X Kong million in has only population China.

So is with China, – Mainland step driver. China. second-line in China in the China launch first-line of next will be ZEJULA growth is the definitely a

first very breakdown for even typically, We the confusing have start a – do a for message. we is very year. six for No, good strong that overall it's really we to CDXX? very the like PD-X, think this And for And the forward we second growth right? mentioned, at sorry, people competitors, months, I'm seen next stage look for And optimistic remain your It's question full to companies, just not I you've details. half. the the

Fei Zheng

CDXX, yes.

Samantha Du

Yes.

see, to do go from me as efficacy the function. because definitely IgGX factor you specifically or see we as let say, I data and CDXX – humanized reduce say – all, is internal profile. of monoclonal some it's pre-clinical antibody we mentioned, differentiated a the and our other and mentioned, safety ZL-XXXX, I pre-clinical and CDXX First engineered from as back And to

specifically has – very specific So and target. gives it a us that

give going And only have the know we opportunities far, we pipeline, are differentiated, differentiation. we But let they this we again, recruitment. optimistic moving we our combo from because clinics with the very safety mention, there's level, started based some preclinical strong we a want again, on this that's hit I existing this concerns. early to still least have in so you to very data feel We'll it’s just that in not And terms also for the just clinics. more at justification patients the when data we study, from know – secondly, confidence information. And is is all from into so also, clinicals. even efficacy entering in us preclinical, really do see But for

Fei Zheng

so Thanks questions. Thanks. much Okay. my for answering

Samantha Du

you. Thank Sure.

Operator

open, Okay, Macquarie. go please [indiscernible] is ahead, your from line

Unidentified Analyst

phase my Hi also this them ZEJULA, having of game still of in thank question. have guess, there, you late another negotiation which approved Lynparza to enter the first-line Hi. late potential of of taking for kind I coming plan couple surrounding questions, year the maintenance makes the eligible I round especially a of year.

market, But US$XXX it look half. the sales figure, during the when right. at that specific is, already – China, first this presentation, if first have half don't I the in is emerging which think, we we shows over million mainly AstraZeneca so-called So, does we

cuts I So this versus we may have have that's implemented to into that that quite get also, think NRDL. consider that And multiple factoring that's early a to the big price they be already in the year ZEJULA.

that, have the are So, off-label in XXXX, same they open volume in very market. then maintenance of away we if the Hungary [ph] year. still in terms competing from another we far this Lynparza. potentially indication may And first-line And included have users later after

be on ZEJULA. of go a guys comfort So you will to XXXX. kind quite these that you show market like particular major two players? a question can entering that's give able to against Any So us fiercely competitive

pending study guess approval I think, not in small I on upcoming that, the right. your guys Secondly, Ripretinib, on you a are a bridging China. doing question bridging – But is on

is the priority get review, that's the particular There approval. NMPA got wait already that need independent. And guys for go guess, kind so you. push second to margin data you totally guidance think, satisfy to to so thinking of should any for still launch line That’s you I Billy, that? also no fourth Or would first? be you a for kind gross I for SG&A R&D go question that what full And to expecting just sales what to for, far, year we from the a going of judging are question trial. dynamics for the what's And you were second stabilized and line China? And final from line, question guess I Thank Like besides expenses? Zejula? one. second is harder? for doing guess, I the like we your

Samantha Du

question. Good Thanks.

line First let’s been applied gBRCA. has product third of [ph] for Hungary’s all say

second line not first it's So or line.

is this differentiated. So very

Second years see ahead much as the do market with half. and one, you a because I agree We two you, Lynparza a in for very good been the have first see sign welcome that revenue from of us. they

the So when than they even China, in is that – Kong we launched year, of market going even And first of be fact launched though launched to have in the just first huge. means months market Hong XX more Lynparza the within we us. all XX% ahead – we was of share

work highlight – line, only the commercial just And original fantastic we last still private second reimbursement. job is we covered at we the the again, with XXX – – XXX five launched to even first months, with are let we work more I published are to with think in even Secondly, from ongoing have, for mentioned work blood-brain have the our reimbursement think have line, pay, than for done we on partner team – to our And that scientific we to coverage. hospitals. And on to we the And beginning. China, hospital second me second are differentiation, on I based committee reimbursement, on done in unique Tao of first the the differentiation, be the the eight in next penetration four and the based to but patients, not will patients. metastatic period study data compared for to – XXX we have only competitor; That seen only, we same higher very meeting. is this our times we the have on high Chinese launch not insurance, have And though this year, line we even months. though XXX are

very in XX terms also we the for manageable, sales by have and the anemia. even thrombocytopenia especially seen Secondly, of the concerns about

say, a also And at XXX a that. see We body you you course, based very not down do have we experience pharmacokinetics, very [indiscernible] positive then longer people And to per life. we the do And patients. a even have of certain And once by adopt lost day not much of once, shelf we titrate We instead actually BID. have dose. weight. do high you data. we on dose starting if consider to milligrams, the And

that, But least take drugs. overall even the We with – day. real-world have don't be we go the they to from if take – and sleeping can efficacy the drop some half too once-per-day, from so a the And real-life if important, do you but look may is going benefit, have with do either that’s to not quite have drug patients huge you at from not Patients some drug talk our day oncology go multiple melatonin, once patients. label, SIP interaction, through it especially the people, compliance compliance, day, because for per they You KPIs, do ANDA. Ambien. always think but take clean experience very issues, patients is safety time in take some the with difference honestly, you China compliance, so bed last when experience. nausea oncology to you during efficacy certainly this this of patients And can before go course, benefit we from

million. line. later, differentiated. us. a in of very paints second though picture have underdog, two very line, markets great we XXX that's terms years emerging came good – for That we us not To we second me, are Even for So for absolutely did

be commercial that And accepted, NDA XX% landscape. about in already think team, welcome it – our population. has PD-X, most more in eight talked market. changes – when we've in approved you I of gBRCA XX% I China. fundamental China. have put launched pro this We and is And And in for players make will team I the always six on the this the think did open with most to review. line, products space top-selling the this But overall again, this comes, priority to timing competitor up of the the been to mindful, gBRCA First only really get

our very So of confident we are team.

I am you little I can the bit is, other so And question other a the – What’s have? question lost.

Unidentified Analyst

Yes.

fourth The your is line, question Ripretinib. other basically fail Because right? competitor

Samantha Du

Yes.

Unidentified Analyst

line And ZEJULA on. does going trial second a have

Samantha Du

Yes.

Unidentified Analyst

you fourth plan gives line the strategize, what's next more game it the second years? to like in some space versus line, few So

Samantha Du

Yes. Yes.

we first tremendous review, very opportunities line that, definitely of start with however, especially – line, fantastic not for as than – the the all, done accepted what job in fourth already only course, and third-line effective, line second do will for on now to with launch [indiscernible] right on line the actually right? of to got that. we First second And But the do indication. that's population, other second That's and GIST So line for all-comer. much important. our has move NDA priority forward a partner fourth

you move line. second plan to the to like a already we we and also, to We said, look recruit have patients, forward

well. bridging fourth the trial we already also or not. mentioned we to got you fourth line acceptance matters report For And really line, review, I our our have priority has whether to patient gone recruitment

needs to work generated and this We with or we'll unmet data’s. have patients. medical to agency bring not, Chinese it's whether needed many already And

whether GIST line much needed this second about in indication is in optimistic big China. very are product very We – a China. line, is fourth

Jonathan Wang

guidance. I me, which David, more question forward-looking was for you And believe had one

Unidentified Analyst

Yes. Yes, thanks.

Billy Cho

just our provide yet David, not XX all we quickly – very of chime have progressing very sheet; question. had strong fortunate in this we forward-looking in I'll guidance, portion have position well. interrupt to, you and a But opening b, up. as, And But do already mentioned a, programs balance your a are

SG&A cancer question initiative. first all juncture – that And program will our as as the intend part is within a growth and our had reviews. of to or NDAs marketplace. gastric well prepare to prior be we to on submitted just with also out have as do three continue coming we of ripretinib, So all we you already them fund at this that And a

again, we're where think So are various a in I we initiatives. fortunate place funding growth

that the your to about I half asking I far and at margin as you launched it combines that as As end China well elements. was on think ZEJULA, at margin think use last XX%. whether as first I the gross gross June, very – includes question you sales results, the of Optune well, various the since Optune look would current as were – if

kind going I specific gross a as of would So margin forward. ZEJULA not use that

still for we're in out relatively the wait additional to still products. want for results may as both curves You we – but are not relatively, ramp-up early

Unidentified Analyst

Billy. Thanks you, Samantha. Thank

Operator

last you. ahead. question Thank the our Yuen from of And line go is Wilfred BOCI. Please

Wilfred Yuen

you Hi, thank the for taking progress. half congrats my on questions. first And

two Just quick questions.

– trial potential the CDXX it Ripretinib, First, global accept responsible China many patients that the pivotal – data we and bispecific for actually, regulator will are for our potentially pivotal for China approval the later on. how as

organization commercialization now commercial – is that plan share in us for staff question the have half you second we with team. the I understand second The can that – XXX

we've would to ground, the second for just what's I two on like and Optune given you. in up the plan the that the half, got see products ZEJULA. gear Thank So to

Samantha Du

Sure.

contribute CDXX, – think right? we we're question And were – is approvals with CDXX partners. other China. throughput, for are the contribution work And necessary we in trial, And in still detailed many numbers, sort – asking Phase what the – you I of for right, the how X. still in for and about will our

And So let's the see. another…

Wilfred Yuen

well. as CDXX the And bispecific

for CDXX, the the also we understand right? trial, I global are So contributing

Samantha Du

Right.

Wilfred Yuen

So can global approval to – on? order later we leverage my NMPA need we many patients the in our how actually contribute question trial to is for

Samantha Du

enough justify you your question, missed the last Could And the I answer last sorry, I'm is, to approval. also that? we repeat incorporate will Yes, question. your China's

Wilfred Yuen

that can Yes, plan our share commercialization. commercialization us half? in staff team the you with your I understand now second on we in have XXX the

Samantha Du

cover want you Tao Right. that? to

Tao Fu

for Yes. Thank question. the you

have you focused Optune. So as currently on ZEJULA know, on focused know, sales two one one and teams, we

sales about sales about XXX covering is team XXX hospitals. And XXX the XXX about team covering reps people, the XX So about ZEJULA Optune is to hospitals.

we're years one on even launch. So building up will coverage adding to Ripretinib is go be also have our we to incrementally the this as other improve we more. comment And for

sales to force, second the the starting place – incremental half GI year, the to starting So the more will put be That's in of we Ripretinib specialist. going in of target too.

of we Yes. sort So top the line those the plan have. are

Samantha Du

private. a with we as to also, as are – just currently currently we are a reminder, And

NRDL. So not on – we under are

and as be NRDL So appropriate. when we as we'll to it organization, be commercial after we'll need the up aggressive changing beef

Wilfred Yuen

you. Got thank it,

Operator

to Thank our conference you. management of to remarks. end I This the like the session; now for closing would back question-and-answer the is hand

Samantha Du

operator. on you, us throughout today. the on to Thank support; you time for Thank taking call to I you appreciate now thank to Operator updating you, everyone. can everyone disconnect the We our look your the want progress forward periodically join this call. year.

Operator

concludes Thank for gentlemen thank you your that conference you. participating. And Ladies and today. for

You may disconnect. now

Zai Lab Limited (ZLAB) 13 Aug 202020 Q2 Earnings call transcript