Zai Lab Limited (ZLAB) 11 Nov 212021 Q3 Earnings call transcript

Company Profile

Participants

Billy Cho	Chief Financial Officer
Samantha Du	Founder, Chairperson and Chief Executive Officer
Tao Fu	Chief Strategy Officer
Alan Sandler	President and Head, Global Development, Oncology
Harald Reinhart	Chief Medical Officer, Autoimmune and Infectious Diseases
Jonathan Wang	Head, Business Development
Michael Yee	Jefferies
Yigal Nochomovitz	Citigroup
Anupam Rama	JPMorgan
Jonathan Chang	SVB Leerink
Seamus Fernandez	Guggenheim Securities
Ziyi Chen	Goldman Sachs
Yang Huang	Credit Suisse

Call transcript

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Operator

Hello, ladies and gentlemen. Thank you for standing by and welcome to Zai Lab’s Third Quarter 2021 Financial Results Conference Call. [Operator Instructions] As a reminder, today’s call is being recorded. It is now my pleasure to turn the floor over to Mr. Billy Cho, Chief Financial Officer of Zai Lab, who will make introductory comments.

Billy Cho

operator. you, Thank welcome and Good everyone. morning well Zai Lab details ended release and as the a the issued September update. company’s XXXX quarter press of third financial providing the highlights recently results product as XX, corporate for the The Relations the ir.zailaboratory.com. section at Investor press website available corporate of is release in company’s by be Today’s call led will Dr. Samantha Lab’s and Chairperson Founder, Du, Chief Zai Executive Officer. Jonathan for Development to Dr. recent collaborations three She potentially Business will discuss of be Wang, Head joined medicines; new by transformative our Global Development, with of who Sandler, will candidate; balances Head Alan President the Oncology, our Dr. discuss and product oncology Harald will Reinhart, the in discuss will we with financial our conclude Strategy CMO, the two Autoimmune about made will I who who performance and comments on of Chief Infectious have in Fu, Officer, speak results Diseases our therapeutic market quarter. Tao areas; and progress products;

all portion Q&A We during to of the available will questions answer the be call.

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

Samantha Du

latest third call, from will Thank and joining discuss us. to you, beyond. this for our expect thank yesterday quarter, we exciting fourth and the we to new in everyone all deals including you On what I announced Billy. update the Hello, and accomplish quarter two highlights you give

strong continue portfolio, best-in-class growth in business. advances portfolio, differentiate and am entire our its terms important we I expanded innovative which share across products. we establishing for and partnerships new of deliver and product and/or pleased performance to vertically to our our We very potentially you breadth. with continue We across first-in-class to horizontally by both that X made depth

BLU-XXX, expand two agreement Medicines Blueprint our and opportunities to cancer cancer BLU-XXX franchise. Our with world further for class compounds, present lung promising lung

deal product. this therapeutic to progress significant Our with with neuroscience, and fronts: a new In quarter provide regulatory enter made additional third commercial. the details asset, Karuna an Jonathan of Lab Therapeutics XXXX, us exciting all R&D, KarXT, Zai allows anchor whole BD, will across Wang area, about

to innovative in data and continue Innovation, China in develop NDA to first product filing. potential We discover pipeline of Alan, We for China. and to for FDA proof-of-concept recent We regulatory expand on mild accelerated approval OPTUNE elaborate the to and IL-XXA gMG for elements Tao ZEJULA, Demonstrating ZL-XXXX, minutes. We trial plaque to those in several the prepare an candidates exciting efgartigimod, approval from proof-of-concept have VERY from and for the of our and file many milestone exciting and announced at to internally sulbactam-durlobactam data developed Harald efforts on to as will proceed Lab for for medical indications antibody positive worldwide. rights psoriasis. as expect clinical an at ZL-XXXX to achieved was HIGH regulatory now suggests topical Subject QINLOCK. update our products of possible a NMPA we NMPA, pathway generate our a meetings. meeting positive had which Zai growth for with in will treatment half discussion moderate clinical further novel XXXX. with ATTACK of fragment strong with the for revenue a important global few

for We in continue to bacterial fourth and by community-acquired infection skin quarter. skin expect and pneumonia bacterial the approval of NUZYRA structure NMPA acute the

next our of are quality, are strength products to for mesothelioma and expect depth We we in X several progress of preparing from in and breakthrough have designation. numerous late-stage therapy continues XX globally now grow already in pipeline over We approved the for innovative in in global patients margetuximab in cancer. and tumor FDA have fields X clinical making assets enroll China And U.S. development, regulatory which treating filings to trials in to XX and breast have the strength, breadth our been pipeline received quarters.

In our worldwide trials full programs and clinical global in that includes and proof-of-concept addition, including X growing XX advancing into early-stage pipeline with rights, achieved development. one

productive very a for XXXX. far so We year have had

be two Jonathan? and in that, to significant milestones fourth reaching speak our collaborations. With ask our expect XXXX value about now unlock business. to We quarter Jonathan our I’ll to

Jonathan Wang

Thank you, Samantha.

we two broaden that As yesterday, collaborations pipeline. mentioned, strategic announced our Samantha and further strengthens

portfolio, each Blueprint on inhibitors, important focus two we established one where of have assets that the with next-generation our honoring other. strengthen late-stage BLU-XXX lung cancer with and EGFR complementary significantly franchise will precision areas our are agreement and Our BLU-XXX, multiple medicine most

these XX% annual subpopulation will in States, than commonly cause is lung in cancer is cancer recall cell cancer cancer accounts China death target lung than for more United in patients occurring The the cancer XXX,XXX China. the in here. China. mutations the largest cancer XX%. EGFR two which most of lung diagnosed type and cancer incidence cell of that approximately common of are compounds non-small And lung lung for more of in in cases, leading non-small to XX% China the You

are TKI, EGFR and care commonly setting. elzovantinib as emerged standard of first-line Third-generation for have prescribed a as such the

baseline is mutant nearly with mutation. for or inhibitor However, potentially disease to is to resistance acquired expected two monotherapy X brain trials resistance overcome its enable metastasis. with a as the begin progression is for trial alone BLU-XXX in BLU-XXX on double inhibitors. treating. mutant It or on EGFR and Blueprint X/X end And and/or all therapies pre-clinically. following lung is deadly And will EGFR osi progression. cover inhibitor, XX clinical before inevitably disease together in mutations, compounds with first-in-class It important CXXXS or high Phase first products, mutant mutation. exon mutation this Phase with generation shown entered combination. of patient which CNS this the a is CXXXS of combination selective deactivating highly has cancer of patients or emerges, cancer TXXXM combination non-small two cell the blood-brain and strategy of metastasis, up deletion a activity, best-in-class to and progression selectivity XX% resistance is year. triple There lines year. fourth because either and agents the are mutation the lung target These patients to barrier, of BLU-XXX for of treatment. these in which EGFR different coverage approved populations leading coverage for other with together EGFR antitumor has across potential LXXXR with is to multiple either providing also EGFR third-generation our enable target is osi, other potent combined are It in prevent EGFR potential both harboring, disease. major earlier plus wild-type demonstrated use causes development to involves the The it best-in-class clinical EGFR activating compounds from disease potent Zai no

in to combine exclusively schizophrenia opportunity drug develop Yesterday, Karuna Zai announced have or this and Lab KarXT In address including urology, BLU-XXX efgartigimod. several dementia-related with exciting also collaboration an other resistance mutation. commercialize enables to addition, candidates lung already We to collaboration Greater psychosis cancer China. with in for and BLU-XXX off-target we products

an Zai our adjacent KarXT and infrastructure for So this is synergies. can to expansion create leverage existing

in clinical a believe with same neuroscience. will as lethargy, lack Just patient do area and the is about trial, as and in in such EMERGENT-X demonstrated showed pleasure, dementia-related autoimmune Sandler. medical There In Phase Phase million scores, bringing KarXT is strong significant gave for X, was these. we a China in us the and It collaborations vertically and Phase an large the profile X efgar compared population horizontally and needs. existing innovative first-in-class from in is floor in patients. with significant Alan? schizophrenia therapies. potential reduced psychosis anchor differentiated asset differentiation negative tolerated a X for data our apathy, also disease PANSS as now and Lab products, patients in favorable withdrawal. of we speech and KarXT to efficacy late-stage such Overall, disorders, million a forward the a Dr. safety unmet two for in asset will existing look with I symptoms and It pipeline, Zai particularly are well of X population deals over more China it X to asset schizophrenia, good turn estimated target to these treatment. And and expanded

Alan Sandler

quarter, product Thank for in third you, the fourth our and the several we further had partners updates oncology anticipate quarter. Jonathan. We in candidates progress encouraging and data our

of X profile patients of response received two for of Mirati XX% mutation trial reported response and they potentially colorectal adagrasib lines XX% disease Mirati, registration XX% control therapies. XX% cancer KRYSTAL-X, with KRAS on rate ESMO. partner, safety prior inpatients for cancer The and at cancer control received of objective cancer of a tolerability at KRYSTAL-X adagrasib, In rate consistent in adagrasib rate and anticancer the prior in X In at which XXX%. a for of data adagrasib while the a an therapies reported treated single-agent response a systemic who non-small lung reported is monotherapy, findings adagrasib Mirati lung the in demonstrating XX rate least enabling, systemic adagrasib anticancer rate Our and previously monotherapy cancer least and cell the of lung patients combination rate cetuximab, in cancer control patients. of the disease XX% with portion and presented colorectal a disease treated colorectal reported GXXC arm, XX non-small of who exciting of cell Phase harboring with lines a

potential second-line KRAS treatment to Importantly, and a plus in We studies cancer XX.X% Adagrasib and second-line the of be cell inhibitor first-in-class has chemotherapy. best-in-class immunotherapy the in global adagrasib half lung GXXC in Phase receiving join XXXX. cancer plan following to of non-small colorectal China. X patients and with first

the chemotherapy previously plus achievement margetuximab acceptable at this of margetuximab, with study least median that trial. margetuximab chemotherapy in treated combination these on in Based HERX-positive to chemotherapy China progression-free of efficacy endpoint and a bridging cancer defined file of primary of XX% year-end. met of was breast with SOPHIA by compound The of Xi’s its results, the in the study. to as around Moving advanced survival, plus SOPHIA Zai safety profile positive BLA seen for in consistent expects Lab indication in the

triple data AACR-NCI-EORTC partner, Our Point, elzovantinib and Turning meeting. repotrectinib the positive updates provided at for

therapy In breakthrough in addition, the NTRK the patients designation plan elzovantinib gene repotrectinib regulatory X with treatment for the solid of an have breakthrough the seventh repotrectinib. to for for the second quarter portion and study the join that Phase fusion, of We SHIELD-X global received FDA designation therapy by XXXX. designation tumors overall in advanced is which

that plan China treating during of submit in for designation patients with in pivotal trial and the modified Deciphera analysis. in and Bemarituzumab trial. HERX-negative further gastric malignant that Phase regulatory clinical and QINLOCK metastatic gastric the X last meet was and combination I’m of cancer fourth for pleural join in in with and aware granted initiated result locally trials for primary FGFRXb you’re in GEJ to our are this cancer a failed X We of a treating fields cancers in fields, in sure over X We trial tumor disappointed mesothelioma. tumor therapy completed quarter. we its first-line and Friday, waiting pilot ovarian entry this announced enrollment breakthrough were endpoint to and global advanced Amgen Phase quarter. surprised pancreatic treatment expressing filing cancer FOLFOXX. bema gastric Phase global to with For cancer

demonstrated Deciphera, in care standard still significant to addresses fourth-line going unmet partner, major collaborate a It including will has of remains setting. medical and is combination our with needs. only benefit strategy. product Note QINLOCK the a steps forward, possible next for including GIST the that this determine patients We benefits, that survival

we working and We with for continue the committed Zai, development. world-class China a to cancer we products China best-in-class patient multiple products and strength had registrational of potentially cancer globally. medical a have we our first that X GI non-Hodgkin’s in key community odronextamab area portfolio fully Phase lymphoma, Regeneron’s in gastric enrolled are to schedule. in of is In global and GI and cancer in in trial partner, so first-in-class potentially the hematology, recently many announced on

are pipeline floor the We Lab. And at our to over Zai very Harald. now excited will oncology turn about I

Harald Reinhart

you, Thank Alan.

quarter is had third to efficacy non-inferiority statistical patients autoimmune encouraging very safety Acinetobacter Test baumannii. a infectious XX-day advance patients results statistically or evaluating several next to high regulatory it pulmonary our trial, surely of there the a response stand clinical baumannii, and our from The brought registrational with known in They developments, clinical Phase X primary comparing ATTACK the sulbactam-durlobactam, franchise. our CRAB, global new top was pipeline by partner, Entasis, carbapenem-resistant and announced with colistin mortality. of SUL-DUR Acinetobacter and trial. Cure, This in line all-cause as diseases Sulbactam-durlobactam stage. short, Recently, to met the mainly The of serious infections for SUL-DUR. infections endpoint in caused with the at

look In achieving treatment are statistically infections worst study, man. nephrotoxicity the are a CRAB in efficacy SUL-DUR met drug investigational is clinical to nonexistent. objective well-controlled bacterial trial. options versus the CRAB forward to thus spectrum the first infections And demonstrate primary drug in SUL-DUR preparing reduction with colistin. to against actively collateral bring Samantha effective frequently prospective, almost known China. CRAB the SUL-DUR as in amongst of a severe result Safe and addition, safety CRAB regulators a the significant in to seen spectrum China to noted, We narrow potentially where And broad this file SUL-DUR antibiotics. bacteria antibiotic infections ICUs are mortality. with associated targets we in and damage avoiding are preferentially, as high

antibody human on our VH novel internally This to is fragment. ZL-XXXX. Moving developed anti-IL-XXA

in showed topical We XXXX of Xb a safety In an showed a score reduction greater was higher placebo was clinical lesion to components, was arm. study, have end lesion or this key psoriasis. lesion There novel XX% benefit the developing improvement. compound are patients absorption, study. for XXXX responder in There area target moderate XX% to responders. the in Phase for severity formulation contrast to This to it a XXXX plaque at proof-of-concept had X. fashion. with mild X plaque erythema and in to XX% weeks profile patients increase with compared the maintained local XXXX studies psoriasis local psoriasis. systemic profile. XX% XX% of for double-blind The relative We confirmed In and placebo have psoriatic size week of these of from had treatment in recently achieved psoriasis PASI first-in-human the XX% treated indistinguishable Pharmacokinetic worldwide, points improvement a safety of the reduction these to after rates And a XXX XXXX lack time, psoriasis benign to with index treatment PASI. was a explains placebo placebo. in placebo for of a tolerability disease. up PASI or X observed compared are size qualify prolonged of Two after target scaling all-time million responder cases its about clear analysis, weeks. a and which also versus and plaque as to in in

– psoriasis concentrating first inhibitors but We they mild are treatment are for psoriasis precautions and those IL-XX are warnings to administered they therefore topical developing IL-XX XXXX various severe subcutaneously are Currently for are plaque as they labels approved moderate in sorry, only. chronic to disease. effective, approved their for Because moderate and the directed on mild immunosuppressive, absorbed with and psoriasis, for systemically. carry

absorbed safety On the compound forward without in applied concerns XXXX look systemically. into development, registrational treatments this being inhibitor plaque can use. existing create is topical long-term lacking psoriasis unique full psoriatic other a are to We for topically hand, IL-XX including the with to efficacy or advancing studies. that be

regulatory partner We also which argenx. with we achieved progress important efgartigimod, for

FDA decision the the the of a our regulatory generalized gravis quarter of on filing efgartigimod know, XXXX. by for during you fourth partner myasthenia As expects

positive on efgartigimod, of discussion further for we for with gMG a mentioned, NDA the and by Samantha potential meeting approval suggests to China in Subject China. regulatory approval an As first had pathway the FDA of which NMPA accelerated expect to XXXX. with NMPA, we in the file U.S. half the

skin colleague, my progress commercial NUZYRA acute about of in structure approval year. omadacycline and products. we infections bacterial will now And bacterial skin pneumonia China of our speak Tao Lastly, the expect community-acquired by with end Fu, and this for

Tao Fu

Thank you, Harald.

performance. continuing marks our products, a The three COVID-XX all great of the building the XX job and launched difficulties, the up third these China, perform a overcoming presented delivering included certain indication did in second-line well, our flare-up which a in momentum quarter regions access last ZEJULA NRDL. the commercial when was ovarian challenges sales in team quarter ramping strong cancer period on to commercial the Despite from our in progress within months. continue

executed ZEJULA strategies brand. team to key grow two Our

First, our a our laser-focused increasing landing. listings of been NRDL has team hospital on result as

in XX, ZEJULA September of nearly listed in X,XXX hospitals XXXX, As was China.

and ZEJULA’s first-line to By market on quarter for only the ovarian our cancer. approved to carry for ZEJULA’s market the patients by NRDL PARP both label the inhibitor of strategies, share expect drive negotiations we first-line into we and team momentum were when to the differentiated to monotherapy commercial the executing number plan treated, Second, in all-comers fourth revenue new grow as able these in penetration ovarian into we enter focused cancer. two leveraging pull-through

cancer. PARP OPTUNE market-leading the is inhibitor well. the be will ZEJULA time, for over in ovarian of going that launch confident Similarly, We’re China

expanding commercial coverage covered municipal focused quarter, of added newly to benefits, OPTUNE a OPTUNE. target good by implementation provincial team third in is some XX insurance market for physicians or and about OPTUNE plans and the improve clinical The the Currently, opportunity survival by insurance our grow us of to supplemental quarter insurance presents continuing its significant on educating access for including plans. benefits. the supplemental fourth During

We to increase have treated. off journey platform campaigns the kicked plan patient of number also education GBM management physician several establish patients to a and important

focus treatment is fourth-line launched as patients launch regardless Greater In status the by of the status As the first trial of May, we that of we’re received parts line quarter, for and later making the QINLOCK the to INVICTUS and in still the the our successfully of available in last third launch approval well treated leveraging the year Taiwan, by The of as recommendation last and product Society the number QINLOCK our also early guideline very awareness quarter, of the China key only data noted we Clinical region we launched GIST increasing mutation as ever GIST physician process. for and all Chinese China is launch. it first in Oncology. during QINLOCK

mentioned Alan INTRIGUE of assessing results. the earlier, As impact we’re the still

QINLOCK and GIST survival, profile, will product third to Billy? our the will we its quarter extending establish And patient results. committed based for financial now adjustments compelling Cho treatment Billy We’re on as commercial to our standard fourth-line make appropriate strategy. discuss

Billy Cho

significant our $XX.X our in briefly financial the We you, Thank continued year-to-date results quarter summarize million, and Revenues XXXX. third respectively. XXXX strong and were as for across growth as year-to-date third million Tao. well saw quarter performance Today, for the $XXX.X business. I’ll and

and $XX.X were revenues year, last respectively. $XX.X period same million, the million Over

$X.X the product were the million, oncology same growth over third expenses were many was strong early over primarily licensing $XX.X and is decrease payroll year-to-date respectively. period $X.X and in sales for development compared X million, third first late-stage million expenses XXXX increase were to platform from lower And period million, September was trials XXXX to for anticipated, XX, agreements, launches the for over to considerable sales respectively. pleased million and last attributable from three related increased And for payroll-related XXXX, continued OPTUNE for for sales for million $XX the and in sales September trajectory Lab very operations new quarter ended expanded X ZEJULA and quarter and R&D year-to-date Zai the launches $XX.X for initiated China. generate million QINLOCK The time to expenses same ZEJULA payroll sales our XX, primarily Research its $XX.X the and commercial year, of million XXXX million, activities operating as compared commercialization in successful and and with commercial $XX.X increase XXXX, by our expected million were still but expenses respectively. same $XX.X to $XX.X XXXX. administrative commercial sales payments period and $XX.X the payroll-related were quarter $XX.X ongoing was more XXXX. partially the headcount upfront headcount. were phase, and last the $X.X With Selling, products. Greater our same general million $X period due and clinical million year, We’re and to ended in leverage. to million, R&D third respectively. months expand OPTUNE and expenses in months The million respectively. offset throughout $XX.X and commercial and newly expenses increased and year-to-date we’re

for compared a Zai same a in reported attributable to net loss months Lab or $XX.X XX, the XXXX, share to of common $X.XX $XX.X stockholders period $X.XX million loss or ended X million of a common stockholders XXXX. per per loss a of net of the September share For loss to attributable

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

Operator

This Please go have Jefferies. the Yee coming line question. from We first Instructions] Michael the ahead. of is [Operator from

Michael Yee

great and very you had much, We questions. two thank congrats a quarter. on Hi,

business market the neurology means also and opportunistic how synergy what about that, Can development now And comment efgartigimod, argenx level just you that you obviously, if announcement the remind about of neurology, and question you? nice for going us pretty potential some your the faster forward? could in filing And you’re made comments big opportunity a the Karuna you Can thinking is, you and for that in had And would on XXXX? The about one. be second a brings the being in was, regulatory first transaction, discussions just on compound. this complex but into confidence you do huge.

know So just to you possible. actually think Thank would we I – love if that’s you.

Billy Cho

Mike, the is Billy. for Thanks, question. This

I’m noise. members As sorry our several management of about the team, background

We direct members several have of some our management traffic. on, help so I’ll

For into I’m will on I’ll colleagues needed. your first in don’t question why Karuna this? our take other Jon, neuroscience, – and entry you sure And chime as

Jonathan Wang

Sure. question, Mike. Thanks for the

to I neuroscience. go areas. there expansion been similarity for is in actually to autoimmune and we adjacencies done into with and new think, diseases a efgar of a There the sort with our as obviously, hematology going Regeneron of, collaboration. what we severe past this have lot into strategizing thought all, first Like going of the is

in similarity, case, go with areas, this we of all, where new there is go the when So into similarity. very care always drug, seek especially is first this concentrated. patients China, that In is

departments a in addition, them is patients the of psychiatric within these get Class a them. care, psychiatric of X,XXX them. there very number is So limited of XA limited very where hospitals have hospitals, only about there large go And number

if second XXX to within urology, is between And is I that somewhere to in some FTEs. force area, therefore, efgar, to of sales companies gMG. look the commercialize I there currently this the because in it’s XXX adjacency is sales amount look So team is that is think point their at you business my our mean, indication China, of in current very focused you this that’s leading first brings to the required if limited. at

So on before commercial care launch the have networks will selling already up KarXT, team building area. in a efgar this we hopefully, we ground, the and

It’s a of been slow very oncology, market. a behind as immunology, one in it’s neuroscience. China. largest It’s into we right TAs go process the very big So

product. of is double-digit very even there innovative though lack In fact, ETA, grow a growth, high very

of So being safety side as differentiated this efficacy on well the both to product care differentiation offering very side, the compared standard clear today. as

in very bringing in anchor viability, new our product. area, adjacency, product, terms are of given de-risked differentiated about future And We an the the the when given into we product. urology, a confident presence look, BD commercial we’re assets, get late already stage a

is our here. product first this So

our late-stage on We’re obviously that continue and going synergistic pipeline assets. be with expand this may we for CNS the assets But be those. certainly de-risk for to and lookout similar with will to look Yes.

Billy Cho

your question Mike, And make earnings second quarter your on Mike, our efgartigimod, announcement for yes, potential have the on we for question right, that an to second first approval this? half your that. year. for question level confidence provide did we was commentary submit the some you in to of on third you’re just first indication by of next – And would our then Samantha, like

Samantha Du

accelerating first meet half Definitely, this in question. Thank optimistic about to the FTE. and whole the we based on XXXX of our potential of process Michael, the the with very for you, Sure. are discussion application

Michael Yee

Okay. Thank you.

Samantha Du

you. Thank Sure.

Billy Cho

Michael. Thanks,

Operator

ahead. We Yigal from have coming Nochomovitz of the from line the question. next This go is Please Citigroup.

Yigal Nochomovitz

much Hi, taking Billy and thank had team, I questions. the three. for you very

market begin for seeing in second-line sales finally, share China wondering are launch? And X introduce sales gating ZEJULA in across current ZEJULA’s trending been since sales about Second, I’m how and curious has that Tier hospitals, and market the distribution across just of was X X, I share revenue about ovarian factors the the is guidance tier available. XXXX when you for First, most the to where tiers? for and curious, also will what evenly ZEJULA certain Is or ZEJULA the just a for OPTUNE? whereas you’re hospital distributed ZEJULA there

Alan Sandler

your you for thank Alright. Yigal, question.

off all if needed. join on it kick and I’ll invite colleagues mean, three I to So other

specific market line at share, second this guidance not ZEJULA So we are point. providing

information PARP in the the on can with is marketplace, in that with do only first seen you course, of Clearly, share but line, penetration, of cancer. the first-line second only as then, and like get so in etcetera, market And increasing views also introduction to throughout is in NRDL the it. increasingly not ZEJULA I ovarian You all-comer can in which U.S. labeled What IQVIA, of the within the both the that’s line and second PARP with it. Yigal, you, share we’ve access product within our inhibitor of an the also reimbursed pie line.

we’re trend So this that continue. will very optimistic

future. And we not could that are progress. And have ovarian are space in ZEJULA as hopefully, for make color so too share commanding further additional to the the we we And helps up set distant cancer market very really in a confident provide that you. position here we

X, second of the question clearly, Class X between sure distribution X initial of penetrate that focus And with X hospitals the benefit that strong execution. make – we the X, our Your sort on have X legacy we Tier cities. and the hospitals in to you or the of Tier of ZEJULA have geographies, top benefit was sales really

But first-line with we coverage. the in NRDL, second have Now pay. still line nationwide the is private

that’s factors the and are real commercialization, strong are continues very on in still dramatic Lab, up, that for that and every are also we of to were we as terms going revenue in hard Zai for to a clearly, momentum, of execute as guidance, and commercial growth goes terms as productivity. optimistic early month so in And guess, noted negotiation call. the well. NRDL more a our And volume of But our – lifecycle a positioned by, much well but inside we platform more I getting going data you we not And broader then any are only when the on distribution well. impact we first-line also see gating

time, So, point is but there moment. not will be this in that at in a point time

Yigal Nochomovitz

Got Thank much. you it. very

Billy Cho

Thank you.

Operator

from from the Please The Anupam ahead. line Rama next JPM. go comes question of

Anupam Rama

ones. business so two those NRDL there will Thanks Maybe neuro be about the taking side? for so Mike guys. question. mention got place kind of ZEJULA, the QINLOCK have also a on second was there first confirm Thanks effects that up Yee’s on take I and much. question could to And in to build-out quick neurology, development, is following talked I then going submission XXXX? a also wanted think when line pricing of be NRDL you but for research I an on Hi internal effort much of question,

Billy Cho

I first and will address your the question. second up Anupam. on key then Hi team for your question it

yes, you right. it So heard

be particularly negotiation, line, NRDL for happening. – in first line First will

We will to to domain will for we a What determined. the good very years, hear the the drug drugs happening made And be that public you and the be and optimistic last by of the near-term. made on know which made are signing companies prepared you negotiation we who that well prepared previous year will be have NDA. a the but the that’s the in weeks and outcome, then are after where NRDL well few similar in is NRDL be and accepted public companies – are most finalize, very it, will it

of be you not March January in that implementation like year, not was will is happening last next January implementation of about be this year, hear expected cycle. prior date, which So, likely year until next the in will where to like the date early – year, March, XXXX usual next

So, cadence. that’s the

optimistic position very PARP class are we important for come. share more for be in to again, drug or market will cancer a many so And dominating And But will patient. the a ovarian patients. will be that have we commanded more ZEJULA there

we eligible we Now XXXX, which label XX, for launched advanced October in eligible. negotiation. were We in included the GIST NRDL QINLOCK, to means be were the

to established We as an have adoption of only as in because not to GIST. the Alan care, standard a we elected advanced really mentioned, and have ability drive as

next so opportunity have to And we do enough year so.

have we And good there. so optionality

just and research know, mean, towards as of our neurology, terms been are Harald, Your building really out. we Anupam, other, to know have if on our out or don’t there, comments harder dedicating capabilities neurology, if that internal you Samantha, you of but. energy first going in oncology autoimmunity. additional in I question press that on terms this Samantha But deal, to where I Alan, it’s build have we we but so yesterday, Harald, signed or

Samantha Du

ahead. Thanks Yes. Billy. Go Thanks.

Harald Reinhart

has to Hi. our you is a is It franchise. yes. require be it does neurosciences, the huge and This will Will current for dedication, It the there Yes. require This build-out new work. and addition question. in Thank a extra big answer two potential. a big neuroscience as the gMG, side, extra is it’s an obviously, on least programs but and before, or neurology, new at are mentioned efgartigimod that market in market we had for because world. experience the have CIDP. have, in we that us, not in And is unknown

build-out which will a yes, those also hospitals require have psychiatric in team. clinical be in China and not sales but large will in the commercialization that units, it much, a be will So there too team, for in actually not is it

because why and mechanism. your very look thought other think one well-established other a question, on into out And serotonin. with So, and And point, MX dopamine addition areas we that one well and mechanism do an understand the it’s really this worthwhile. to yet It’s been because the antagonist receptor. hasn’t area, This go an in we everybody approach. we agonist looked is of that at else antagonists muscarinic in MX has tried that’s working maybe a

a of of support also data lot is there in this. So,

really gives it data, with all you. together trial we that forward. the Thank EMERGENT-X something with us sprint this So, of this, can is confidence, full press

Samantha Du

Yes.

– thanks, think thanks, Harald. I Anupam,

point out Harlad this autoimmune. Anupam, about lot interested still remain good information. brought oncology We our discovery, a open of not think terms we with on a research. in in focused and But own building we real I are branch area of into

Anupam Rama

question. taking for Thanks my

Billy Cho

Anupam. Thanks

Operator

you. Thank

coming the next have of Chang. go Jonathan We line Please the question ahead. from

Jonathan Chang

for Thanks Hi the guys. questions. taking

cancer color question, about First study your thinking steps? you potential following how strategy Can around any results? discuss next the recent can INTRIGUE you provide you are

Billy Cho

Alan. to that pass will We

Alan Sandler

for the very much Thanks Great. question.

strongly I overall in showed this and has in a study randomized steps, point, our as think believe which, been cancer survival QINLOCK portfolio again, line for in next setting, world-class specifically, the noted significant very benefits. we particular for at fourth GI

upon So, that. build we particular in work look continue will continue to to that area, and

see In looking the of and combinatorial course, data with opportunities include well. to to as the working forward, are what evaluate could moving original approaches study addition, Deciphera forward potentially have which from we sort we of

Thank the taking that’s be you for this approach much we at point. so question. So, the will

Jonathan Chang

how And any it. is OPTUNE study any study granular color Thank around the provide the Thank to you second provide read color you. of when you. LUNAR question, out? more can Got progressing? able could Are you

Billy Cho

would on as you comment this to Alan, one like well?

Alan Sandler

for waiting from know, for the accrual study been this course, and And and them the still given been the months of is that’s you on by our as Novocure, for in of course, and and the a question. participating XX reduced something XX we that recommendations partner, accruing is study to thanks Again, to – Yes. months. the again run, we that, is study finish. are with by are DMC, working follow-up This has the

of follow-up. terms the So, in minimal

provide might completion a as little that see guidance of bit to will you data Thank we So, of with to when after start accrual. potentially you again.

Billy Cho

I I same out. also now, don’t to the data have XXXX only read and Jonathan, milestone Yes, Novocure be not – that, they will am said final that’s think be

So, half but be I to next going be guided that’s going an milestone anticipated year. have second don’t to we whether it’s to think for first half, or

Jonathan Chang

Got it. Thanks for questions. taking the

Billy Cho

Thanks, Jonathan

Operator

We have the This the is Seamus line question. of Securities. Guggenheim from coming next Fernandez from

Seamus Fernandez

Hello. Thanks guys.

questions. Just a couple of quick

First, its noted AstraZeneca XXXX. Lynparza for expiration in has filing patent document in a

– demand? And the in opportunity expansion XXXX, for stage point X Phase prepare really relates and what’s to should generics for you in the a generics in XXXX the assessing are are how point Just have trial, your feel shortly guys at get anticipating expectation to is the there to for longer? are assessed or not, trial question for landscape the wanted or are that that there my to a LUNAR What are And protected you the Lynparza if evolution patent from on guys of and prepare China? OPTUNE. basically color is – Lynparza the you in potential in time? market the to earlier the doing second more be of patent you entry If bit readout little Should that uptake likely expansion thereafter? landscape not, this positively introduced why

Billy Cho

for thanks questions. Seamus, your Hi,

I you and will I think take it, one, second like take the one? Jon, the then would first to

Jonathan Wang

Seamus. the Thanks Sure. for question,

me Let have patent very first for a we say strong that position niraparib.

And We this very differentiated composition of strong [indiscernible] we product. the have a almost end decade. to of have a

first we that the are differentiated In all-comer monotherapy second market is only label even we So, in Lynparza better rapidly have line. that particular, are a the as to we generic expiration, if share the as being assets. after we gaining have And patent there the asset NRDL very product. comes has we on line are a market

on have negotiations to Now we to we front as NRDL get even stronger position. currently we are that’s line market the an successful will NRDL, if ongoing, have for

product, a very a time with market strong for our a the We dominate broader position, differentiated patent we will solidify with label. I Therefore think that. with can long

Billy Cho

fields, second of obviously, market have half last Seamus, in And on since so the tumor treatment for second your we it OPTUNE, question year.

neurology the doing hospitals OPTUNE radiotherapy Our departments. is dedicated top for GBM. great is about job to and covering in a coverage in commercial team There fact top XXX hospitals great to

signed education. the saw continue our also our dedicated to supplemental have insurance, – to from patient We earnings plans with have that job up you have insurance done we up. that XX release and a a supplemental DSS who And care about team – great they provide and

So, building tumor in this treating indications. and across is future going positioning awareness but the not to really for bode for fields only OPTUNE, well

doing. is be But things year, a next will going ahead obviously, an important to there be milestone. Now we the that, is readout lot LUNAR of of

X by for of global So, in and ton Phase and just a trial, about Phase half addition wrapped X only trials that first indications next will other to we of have out up in we data year.

as to us for community also possible in indication to LUNAR are And opportunity preparing ahead gives it a positive of with have know, the We the been trial. engage outcome a does second strategic lung submit mesothelioma. you cancer

positive. if really was we optimize that can So, it event,

big treating the believers what on many, are we tumor right of now. many remain potential and all serve than continue in doing optimistic those more patients be fields we So, to fronts to

thanks operator. to for So, the next we question, Seamus your Can move question. on

Operator

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

Ziyi Chen

in A tox, of China I the am a care Tagrisso, couple window the EGFR look standard Number assets. two the for questions. on is on to brands bit how Blueprint recent potentially in questions becoming understand like? of more my the strategy does China molecules, generation also to deals. taking trying about going for first-line, third the clinical of because second-line Thanks preclinical in some one to the the therapeutic EGFR, their setting. And domestic including is

And to of the decent barrier them show a also some penetration.

EGFR, So, Any to the study targeting in in BLU-XXX potentially X mainly move will if the survival that the we while trying more beat there China, I a the could population we be patients? EGFR or third-generation thoughts patient lines, also failed here. how the understand understand inevitable. KarXT, the chance earlier are XXX million guess, third-generation tox will is to combo your and of a And bit schizophrenia patient that large about Trying for benefits to plus. into

poor actually a of condition. a them are in However, financial lot

care So, Particularly are be super available cheap. of now affordability given big a standard challenge. might

be the pricing strategy you. we here So, should how commercial And what could potential? at potentially look in Thank China? the

Billy Cho

your you around Alan, would for EGFR? Thank like you take questions the to questions. these

Alan Sandler

Billy Thanks Thanks, Chen. question. thanks and the Sure. for

a of aspects. couple So,

shows that agents, I effects. lump is think together. sort probably there can sparing I for toxicity. of initial the was those wild-type wonderful more two And The preclinical these one data exceptional

that main is And these for of the cause agents. so toxicity with types

– by as should limited such and be fewer diarrhea. wild-type, the toxicities dermatologic limiting So, on effects there the

limited it also advantage. key for then And for have the does these combination two of also it element and the resistance, based wild-type, those the potential TXXXM agents. also is And CXXXS. again, that’s mutations and only such two not agents a these original in EGFR for very allows potential So, combining you a as, what then on data, because preclinical this the that’s impact one you by

coverage is actually, the ways, for can then mechanism, allows similar potentially and because it overcome resistance that also So, of mechanisms. superior some that Tagrisso escape in the that to

combination agents you this of moving a and much at the path our certainly for in to approval. setting to approach. the in an Blueprint, a we logical Thank with faster because is the these to resistance that superior this Ultimately that’s study looking in so although initial is frontline be partners are So, confident, at And Tagrisso area. question. along there be opportunity will

Billy Cho

second Ziyi, your for question…

Alan Sandler

blood-brain They One was one penetration well. last am excellent there barrier also I last question. sorry, minute, have as

these occurs resistance So, Thank the CNS be in will well. you. overcome by agents that as

Sorry.

Billy Cho

all question around a lot for Ziyi, second work And done of invite we provide Thanks, I our will have Alan. But on always this, as color. your Jon KarXT, do of for additional programs. to clearly we

Jonathan Wang

the much – think pretty Look, of generics. to mostly for the it’s are cheaper due I Thanks first all, question, Ziyi. Yes. prices

on a products NRDL. However, very cut recent launch the the on recently are in all was when fact, more is the product, limited. gone to And price there NRDL, the

to only $X,XXX. INVEGA category. NRDL, cost treatment $X,XXX its XX% But X% example, had still to and the annual a undifferentiated to HXT For the price cut get asset is dopamine onto about very it’s in largely

And a pricing. chronic have with new And MoA effects, out schizophrenia, profile, does. is you because X worth usage. million schizophrenia in of the very but with believe which seems We symptoms, do at. a weight is product, of this better patients then least there kind there to much that can more definitely it China, best-in-class only And are with, of about you tolerability, couple at premium is nothing with better tolerability potentially. the very elongations, market, first potential. much a currently negative but So, and symptoms side potential of positive addressing is And attributes I well longer totally importantly, these that its not psychosis, obviously, large on the beyond dementia-related a for bad nothing mean, there currently approved when that example, DOT in is QT addresses then gains, schizophrenia, market

should So, I well. think consider we as

hopefully, So your answers question. this

Ziyi Chen

Thank you.

What KarXT? China here. quick a in for status Just patent is the follow-up

Alan Sandler

The prosecution. the its there undergoing a patents major is two families. pretty family it’s strong. are patent broad Globally, of Look, is primary patent, Yes.

it two APIs. As you includes know,

approved API the of anywhere in is the One world. not

any no U.S., believe up are we the potential opportunity well. overall, and But So, here we as usage. there have off-label to in the in XXXX, is patent we China looking for good a at

Ziyi Chen

you. Thank

Operator

you. Thank

coming go from is the Yang Please Credit have We next Suisse. question. ahead. This from Huang

Yang Huang

Thanks.

So, I questions. have two

the idea, second-line if maintenance term you for can us negotiation, Just quickly ZEJULA first-line. some in NRDL, what think maintenance prescription first-line have PD-X split kind our that’s longer right don’t and a And therapy rough they the cancer a would few has partner the large in of second the of give rough the of quite split efficacy in portfolio, for greater is have of the safety. we more but study rough it are be ZEJULA on first-line my what’s in ovarian First question. included kind with are strategy, combo one doing so can great. margetuximab, first-line drugs. kind see first for prescription our and we and and then the Actually, is of combo all And yet, on second-line in it included now? terms then China it comment seen our doing then PD-X term? since study be in question study the therapy and a my seems for So, a I between about of approval combo longer ZEJULA PD-X, kind is chance a our being KRAS And NRDL ZEJULA,

PD-X PDL-X development clarify of So, or can strategy your you kind in China? Thanks.

Billy Cho

thank for Yang, you your questions.

of be the call, negotiation as for ZEJULA effect going final So, heard selected for year. first next we inclusion, you into have on we been early will which all, related for for question, this ZEJULA, re – first-line have NRDL

product only for I be first-line all-comer that. to will season are the remind we and will profile. it’s we a very And the also you, is differentiated in there and product like market a – monotherapy So,

the a are NRDL share for position. and potential significantly the negotiation market inclusion solidify on ovarian And cancer. the So, will be to we leader our in market again, the into optimistic ZEJULA

saying first-line, won. to indication is is where that the with first-line we have So that, going been the be battle really always

that you launched At product. we And share label. first-line that. slightly confidence was against But want so very recently giving and line well. and time, around reimbursed up Yang still and revenue this split the they between much market to we And as a are second-line it have to have pay continue product, it’s we not of remind although different just private a first kind split

as into year So, we of to it’s we first our – – go we full try as XXXX provide additional our calendar wrap color up commercialization. was really first

much very So, we up. still are ramping

understand. So, you I hope

be in combos. expect you right an a But are just second Alan here. to day But quite ago, what will you invite we have I proprietary. several KRAS, and I the also additional, lung. call, will that that, and realize, incremental In listed the we to days update that on was we question we had And already are the will update, that few interesting. your have a PD-X think strategy, combo for on That in we terms synergies comment ongoing, or an two of future, quite

well. have right? We cancer marg and There late-stage trials even frontline lung ZEJULA, two is large PD-X combo and indications, breast in very as

and great only have and to it’s really you to go what any will so, want opportunities. color? after PD-X, fully But additional provide us it strategic do an portfolio to unencumbered a realize immunooncology be but synergy have within for Alan, And to not

Alan Sandler

for we be on second-generation those the opportunity again, that in job, an I will such other have establish combinatorial as exciting well. to great a There we you, as And too can that, to then did and studies KRAS well, mentioned. of IL opportunities, PD-X as approaches, with combinations we as you retifanlimab one. that go the to than Billy, doing are an other is continue more Actually, don’t certainly course, you along add much will with our

thanks question. yes, for So, very much the

Yang Huang

Okay. Thanks.

Billy Cho

Thanks Yang.

Operator

Zai Thank Lab’s questions now you. remarks. at time. Du, Samantha closing CEO, I the no showing over this for am call will back to turn further I

Samantha Du

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

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