ZLAB - Earnings call transcript Q4 2019

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Operator

Hello, ladies and gentlemen, thank you for standing by. And welcome to the Zai Lab’s Full Year 2019 Financial Results and Corporate Updates Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.

As a reminder, today’s call is being recorded.

to Officer floor will of comments. pleasure Cho, to make my Financial Chief Zai it’s turn over the Billy introductory Now Lab, who

Billy Cho

you, provided call. Earlier Zai morning, Zai welcome financial Thank section a and ended of this morning press the issued year release, results The company's financial conference full the of details XXXX to updates corporate corporate as Lab Good operator. update. the Lab’s press well at is XXXX, company's ir.zailaboratory.com. Investor results for the Relations December the website corporate as XX, XX in and release months available recent

call and by Chief Today's Dr. Founder Officer. Zai Lab’s led be Executive Samantha will Du,

on Q&A Fu, call. and will Wang, milestones by us will will upcoming during Officer, Tao, Valeria our to and joined commercial We answer progress. available myself questions details Valeria, Business Chief the lead Jonathan of the take Chief Jonathan pipeline dialed-in the President portion and and be are the Scientific and on Officer Dr. also refer of needed. questions including who Tao Operating to of some Development, separately, Fantin, Head be more as will Because Samantha provide

objectives and certain regulatory today's timing Lab trials, call, and a the As during and reminder within clinical will forward-looking be success launches. our applications the Securities Reform and Zai our Act plans including business making Litigation statements of Private of meaning commercial of XXXX

actual our that materially I for our expect. results could and uncertainties undue SEC discussed filings statements to factors risks differ are of to upon could differ discussion statements performance materially therefore, from we cause those them. to subject forward-looking refer actual and you should today. These not cause risk reliance results not put guarantees are future from of numerous you that what These to

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

Samantha Du

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

foremost, coronavirus and global I coordination in safe the hope be shows This and contain the healthcare is impacted the sound of has really everyone us. as to important will outlook First all how and global effort future. devastating

note, On us. achievements is provide a progress an and celebration an Coinciding has I inflection the made for the Zai Lab Zai of on five excited XXXX. XXXX update all a Zai in was with greater future at for the enthusiasm anniversary, year many have to for holds I'm Lab important of our point what year Lab. great

the ZEJULA were NMPA cancer. in Some for ovarian of achieved key regulatory approval the second-line China milestones

approval additional commercial and continued Deciphera in our in-house of Hong submissions in Kong Incyte the omadacyline. with platform Collaborative Two capabilities. regulatory R&D for enhancement ZEJULA and build-out Optune Optune global in launched China and further China and of for agreement

new ZEJULA aspects, China, three strategic consists products coming programs two oncology China, clinical IPO advanced portfolio deals rights Optune in disease. key file of across expect Today, or announce in sales our year for as submission. with to as in deliver IND pivotal Thinking our in readouts, evaluated three and infectious global launched submissions during to and promised in line XX being XXXX, more than have commercial have another trials we we off ahead clinical approval with and discovery

We of partner as proud in and reputation choice are our a of pioneer biotech a global China.

exceptional affairs, business deliver development, clinical commercialization execution global across infrastructure and regulatory As we expansion. and development, continue local to

pipeline global transformative with areas, global biopharma internally Zai Within becoming company assets a to years, a the vision partnerships. commercial is our and of multiple believe we reach approvals next and stage pivotal across stream steady greater therapeutic leading well generated China launches positioned of in three

the from our authorities impacted this have impact the early Zai outbreak worth to the both on while unfortunate coronavirus seriousness With China of to globally. too expect outbreak. in first caused impact outlined the be optimal regard at health addressing speak company, event. and be to materially recent currently Global it Lab by the And updates, to not may appropriately does

the across our our implemented taken In to none measures been we addition, have so have comprehensive employees due quickly of far. infected firm,

should We have deal procedures by any with place clear to in will differently the occur. be virus. situations company Every they impacted

key of to our and milestones this XXXX, commercial see seen need have do we change not clinical we two While the during some months at to time. operation disruption certain of aspects our the first regulatory

we regulatory employees’ situation make our sure Having continue and closely. to community, everything can are to and monitor supportive. the said partners this, patients, agencies medical we considering, all very We're safe doing

our Moving of pro approximately business. conditions highlights. to exceeds reached us our all enable financials of proceeds at forma cash million. our $XXX position expand execute announced to the current continue our with recently In gross be market in the We onto should that strategic initiatives $XXX successfully January we end such as of total XXXX, position Lab other Combined cash million. Zai

I'm by outbreak. turbulence of coronavirus also despite that China acceptance caused the February the announce thrilled following the and this to NDA omadacyline

platinum-based ovarian how to change for in has are cancer first-line by accepted the treatment sNDA ZEJULA NMPA a China patients chemotherapy with fundamentally as first-line Our the China. women ZEJULA in monotherapy this believe week. as ovarian cancer maintenance treatment potential for after surgery treated I was and

full measured have pleased but According the only market I’m and Kong ZEJULA year, oncology our PARP by in with leading top also the year front, Hong the last outperformed five in was drugs ranked revenue. to Kong in launch XX% IQVIA, report among ever to to commercial first Optune of share Hong as not that inhibitor targets both revenue ZEJULA the XXXX. On

most to in launches Novocure in one from understand we also successful represented Optune soon. our are Hong last Kong We the of China say, that commercialize year Optune Needless and globally. to partner, ZEJULA excited

on While it's trajectory there the opportunities. comment in ZEJULA we believe commercial too are of launch China, early to significant

needs unmet More of importantly, platinum-sensitive the ovarian have we are already China. medical in address excited cancer started that patients we to

key one pleased our platform I'm long-term Building making growth of the Zai good Lab’s of And we strategy. report that progress. own global are discovery to pillars is

immuno-oncology includes three We signal prioritized of have and translation. response, areas research damage DNA that

of are assets our exploring areas in precision by by translational inter-portfolio and internal expertise medicine building We our combination. and pipeline those the medicine advancing approaches in

We IND We intend into to continue global team all to stage this expect progress to programs two to we functions. to world-class and the that our add year. across and our talent need our global first achieve goals build

facility Boston We in to and office a discovery Francisco have opened this San summer. larger organization year the for this plan

employed XXX R&D in As of Lab with XXX February full-time XXX XXXX, and employees across and engaged activities offices respectively. globally Zai seven employees commercial

Zai very we a our a on the required is time we goal. experience have reach strategic resources global And is successfully scale. mission Lab, to at This our believe exciting and

your and As you interest continued always, and updated to all our of keeping thank want forward for look we to upcoming with support you milestones.

Fu. to call COO, With over President Tao that the I’d our said, like turn to and Tao? now

Tao Fu

Thank you, Samantha.

As and a Samantha further We extremely gained with stage an Optune. the mentioned, successful variety launches XXXX approval new company Zai bring strengthened important further our and through recruitment to China. and exciting and partnerships, two was team fronts. global ZEJULA Zai We Lab with of our top-level portfolio for significantly expanded period many in became enable organization our to of therapies more ZEJULA talent commercial R&D China busy a Lab sheet Mainland commercial of patients. across of expanded strategic balance our We to

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

attractive niraparib indications. it approved the a I'll pharmacological We in believe dosing, of other testing that ZEJULA, globally is an with with best-in-class start efficacy to inhibitor ovarian PARP safety low PARP drug-drug without ability tumor a and and or and daily inhibitor the cross profiles cancer properties, treatment the interactions barrier. solid several superior including for of and development for blood-brain of blocker need once

ZEJULA know, Category by ZEJULA the China platinum-sensitive you the December PARP ovarian line second only making and first maintenance approved in treatment X China. approved NMPA was cancer of in inhibitor As patient, for

for drug to category locally noted Samantha track bringing the Zai Lab’s in execution submission this approval represents China As oncology underscoring leadership patients. fastest manufactured important therapies timeline XXXX, or and to earlier, in X record approval in

patients sNDA In HRD clinically addition, and a recently based was significant for subgroups accepted cancer HR our submission the the benefit. and HRD demonstrate positive negative This deficient ZEJULA meaningful study, the a was or woman by HR as NMPA. results ovarian provision PRIMA that treatment from maintenance in both first statistically experience as the or for line on

with cancer. ZEJULA first of Lab In Phase the enrollment recently Chinese addition X in Zai ovarian line patients PRIME study of completed

label changing game excited an as for this as China potentially opportunity soon possible. bring to to We’re expansion

expeditiously of China, our commercial we’re ZEJULA the drug the launch of in the team this proud bringing mid-January approval. following to Regarding in very market

In challenges maximizing We mid-year. physician outbreak, response of our announced insurance out we Mainland all patient as and by China financial creating and measures consoling lines update coronavirus such the to next reimbursement when commercial platform. figures lift have levels and we ZEJULA taken anticipate and education for provincial the corporate crossed commercial on Getting municipal and results immediate providing opportunities. initial

Hong our perform commercial continues initial pleased of that our to I’m forecast. Kong, In ahead financial to report launch

China, performance key we items. is While initial a to Hong two compared Kong Mainland small market believe validates our

second, And capabilities compelling First, our the commercial of China of region. integrated profile team. the ZEJULA

many the lung treatment we small further in Therefore, our we with our the applied In China X for rapidly Hong Kong of to be press primary launch, patients Phase today’s changing in Mainland study accessing due market. earnings positions the with the landscape maintenance of termination release, ZEJULA niraparib, drivers believe options. cell cancer announced in first-line our can therapy to success

a of we While and and this need we towards to opportunities. pursue label cancer. opportunities partner clinical refocus patients, study first patient other continue resources to attention for indications DART in small expansion with with cell regards molecule combination to PD-X And gastric our higher recently plan work Xb lung metastatic the we and maybe cancer the LAG-X dosed our advanced ZEJULA. setback commercial In closely a indications, MGDXXX, niraparib unmet can in other for Phase bispecific GSK other with

to and as Looking is ZEJULA as to to and We many continue globally. is believe to ahead, who China including order develop ovarian inhibitor bringing plan in benefit a treated beyond possible, best-in-class is PARP cancer meaningful indications patients way on this ZEJULA in potential a committed cancer. to treatment innovative may the we’re making our impact

Mainland Tumor of encouraging to Now the a treatment Optune, we China. Kong, system it’s Optune Hong a clinical turning for can first approval the Fields. in for commercial the glioblastoma deliver half Treating expect very unmet authorization we We Fields marketing of in the obtain and Tumor can waiver, XXXX. Treating receive the needs to If a and success for our initial in address view time trial

may received malignant you As this authorization year marketing U.S. Novocure FDA pleural indication year. MAA China file We know, from to the mesothelioma. for for for an NMPA mesothelioma plan the to application last new approval

major very strategic be While opportunity mesothelioma non-small is China, the for us label in the one not in cancer. next is will the extension cancer of cell that approval lung types even

mesothelioma, number Beyond glioblastoma program. this a are there of exciting of ahead and anticipated milestones

Novocure a to interim which in significant X of from in in China. the has particular, lung Phase results trial In expect cell non-small potential second patients its announce half cancer market with LUNAR XXXX,

ongoing clinical enrolling well. in first an have also We adenocarcinoma, which line pilot gastric trial X Phase

XXX,XXX and reminder, respectively, cancer to XXXX Just over diagnosed the annual gastric national China as lung cancer statistics. rate cancer the patients are according a in for the and incidence XXX,XXX

XX% ripretinib pivotal of review patients of in Now survival progression the announced placebo. the of investigational NDA Deciphera partner control or primary its improved in stromal for switch where kinase our and advanced or The death Ripretinib GIST. of U.S. patients of to reduced In median month FDA from placebo ratio inhibitor based was on disease PDGFRα X XXXX, study significantly February on advanced from to compelling with a the data acceptance and Deciphera. submission priority the progression was KIT with to under study endpoint hazard GIST, X.X met clinical INVICTUS our the gastrointestinal tumors Ripretinib, in compared licensed or compared by risk X.XX arm free one its of months Phase

advanced Zai fourth NMPA the Looking China, for in trial plan GIST China and in line second to of bridging year line with second an half this XXXX. NDA the the we ahead Lab for initiate for GIST submit

Zai partner in our Margetuximab. submission of BLA for This Lab the margetuximab for patients MacroGenics with cancer for first for with the the dosed in month patient FDA in combination And with HERX-positive HERX-positive the with combination bridging follows breast U.S. next chemotherapy. announced metastatic the been cancer. registrational of by of treatment breast study patients with last margetuximab, the has metastatic chemotherapy, treatment

ahead, XXXX. clinical breast final Sophia present the metastatic Looking by Phase in X MacroGenics data cancer HERX-positive to expects trial for end of

addition, chemotherapy, a enroll half the in esophageal X/X In gastric to expects and evaluate by checkpoint Zai for XXXX. geo patients the Phase inhibitor junction advanced cancer Chinese margetuximab, of and of combination MAHOGANY frontline Lab study, second a treatment

omadacycline, update intravenous our with anti-infected bacterial antibiotics for with once acute oral skin a and skin of treatment acquired an infections on finally, and And community pneumonia our daily and accurate structure pipeline. adults

that the NDA has with new NMPA In its February XXXX, drug Category Zai designation. accepted Lab announced X

and anti-infective network partnership in a entered exclusive China or We also area infrastructure player extensive distribution with commercial promotion an we announced promotion today market established into to in that with omadacycline. Hanhui, the leading and

to and in was will potential spectrum a novel setting. commercial community the expand footprint its as partnership this China behind rationale maximize broader omadacycline antibiotics market much broad The

the our the ICUs, global we for pipeline omadacycline different stage assets team portfolio focused to hospitals products As in sales large a and of oncology market to ourselves. which intend on requires backend, our late is rest highly directly that specialized these and including it our

the will financial will our over our hand Billy Cho, With an of who Chief overview Billy? Officer, that, to call I highlights. Financial provide

Billy Cho

XX $XX.X I Revenue will billion for period months XXXX. our results the in to were now $XXX,XXX December XXXX. Tao. XX, Thanks, compared for financial review ended the

in Kong Hong sales comprised $X.X revenues and million Our sales of were in $X.X million the Optune period of for Kong. and Macau of Hong ZEJULA

expenses newly programs. were R&D million and compared XXXX. research for headcount development and primarily in $XXX.X to to R&D million ongoing expenses payroll increased expansion and clinical R&D to for from The $XXX.X support XXXX was of late-stage increase attributable expenses initiated internal efforts trials, payroll-related

to $XX.X related costs increase $XX.X and XXXX from and The as payroll-related compared was Zai payroll for expanded and Lab head XXXX. Selling, administrative commercial to due expenses million general were increased for operation China. in commercial expenses its million primarily counts

or to year For share for share full of net shareholders common net $X.XX, full loss the loss of or compared per Zai a net a attributable million, $XXX.X loss $XXX.X XXXX. $X.XX, to stockholders net the reported loss Lab million, XXXX, per to common year of of of attributable of

As XXXX, and of $XXX.X equivalents short-term million. cash December and XX, cash investment totaled

closing underwritten and with million. of January net public $XXX.X Zai Lab this of year, of proceeds, in announced In addition, the expenses approximately fees offering offering an other total underwriting

your We go We would now to Operator? call like the back to over turn the operator. can ahead question. and take

Operator

you, Thank sir.

We the We will now question. question-and-answer [Operator Instructions] question ask Please begin the Yigal have the of first line [Citigroup]. your session. from Nochomovitz

Yigal Nochomovitz

early days ZEJULA that Thank did headwinds impact the mentioned in of travel on us of what material don’t important coronavirus that, in January. crisis the seeing Thank worldwide regard. you understanding were bit great. to to back the you. launch on obviously, however, you Samantha the get cases with to of has impact a before given physician niraparib, very early I early and launch – a good field know, understand, right, But expect appreciate, coronavirus among the the innings. offices explore having you business. operations, product what potential much. Tao. your Hi, reduced that in starts and you of in I do more, employees. to terms nonetheless, All hear there new Billy be I seeing Very wanted you’re I Samantha, would became in like for the patient or restrictions the that but better might no closed you

Samantha Du

fortunate, this are that before coronavirus in the first and the we And second Thank you, the week also mainly March. you February, mid product half of launched of question. as Yigal. mentioned, outburst That’s during very of January a we fair

So was travel restriction in China though.

not all very deliver one only been – but and fact, to has our January, the day hospitals. three impact you sales of team the supplies I mainly of see half major in mid till look in in XX if at launch, all the of activities So, half our on of in weeks February, also our commercial first second because the effective didn’t approval, in any provinces

But and also outburst even very launch restrictions to events China impact, but we the held and seen have there’s three entrepreneur, and travel keen during – this. we prior in some the luckily very

the sold the the So before outbreak. most we have of payout, major especially CIs,

the so physician and education And also products reimbursed at and a selling February patients during level. by the provincial March response at mid in or challenges online home the immediate we’re we’re consulting on and have also – as deliver nearby platforms on creating to coronavirus, caused significant we the online such to reimbursement, creating pharmacy. working the to measures a And patient taken

first us a local record three month reimbursement. the municipal we Within cities give

also already with company. medical Of course, insurance – that now By we insurance have commercial work they several with patients commercial the treated insurance provided.

Yigal Nochomovitz

then Okay, up… great. Thank And just following you. sort of

Samantha Du

one also even we’ve just Yigal, on and And has China But relaxed I back sorry, more last seen the the add-on we Sorry, because we’ve see seen patients, want for travel report team the business weeks last the two new to treatment. to more sales so just one. come are patients the restriction.

Yigal Nochomovitz

Okay.

basis? what now So the can confirm as field can sales did to not a the or you today on you I’m tell force just day, return sure when me but of full that scale

Samantha Du

the allocate say are visits, than back with But force visits. field. cities now visits full hospitals. the like full hospitals to in not still the I’d time are to still province on the they other other have limited on to Certain hospitals Hubei majority sales has skilled some

coronavirus based answer force situation on in sales. luckily been I awhile. question we of like sales in the have the feedback or way full you’d has end evolution the say to for by see control XXX% China before back continue month And that the report coronavirus to But the in to China. of can cannot situation I So the with for the

Yigal Nochomovitz

quickly Optune coronavirus then ZEJULA in for supply to the integrity ongoing the you’re pandemic. Okay. of any there respect seeing chain anything with clinical and as no? terms And comment rates the impact you for given just respect trials as with enrollment or Can well on

Samantha Du

– First, at the as officially has we’ve product first we I mid the the also been pharmacies, supplies are after additional to the all we supply day first all, not we hospitals, the the back launched have people And already the also they and because work so day if delivery enough in so interrupted to shipped mentioned, we think side, from I supply the manufacturing supplies. and January. – need

in we terms recruitment, because already And this process patient and of one and are close they’ll recruitment, the we have in but mining. clinical have to recruitments we – study, the closed part, completed I on several not major also fortunate quite even say data trials already the

till and last we patient one, we for other back were March February to see this for a week November only recruitment The we more did with – hospital on, see of some on. already patients follow mid but week back early the follow the coming and completed see as we coming in patients now did to XX% more

getting off not the taken yet. look XX thinking also the China’s trails recent CTAs human other genomic of clinical.com in the beginning and they process haven’t are and if office but you we the – we at website, either trial approval at so have CFDA we the in approvals of are announced, has approvals So are the they

many trials, don’t some And studies. don’t need we on small ongoing impact. we see They are bridging and other those sites, usually

Yigal Nochomovitz

you’ve with will by sNDA mentioned NMPA ZEJULA setup the it Is the to the first question line. And Okay. the get the need not accepted want results for that is that that obviously, with case the same. to you occurred as is X PRIME regulatory just first for final the the line trial? got for wait NORA second approval you’ve just to confirm I line Phase then the

Samantha Du

China? You mean in

Yigal Nochomovitz

yes. China, Mainland in Yes,

Samantha Du

maintenance PK/PD data. got approval maintenance first based China, the the U.S. second-line on on study, have year And Yes. do study. this We majority second-line results a based based see also China hopefully the know, by you we’re going as In half the then. the on we this the report also to Mainland of and and we’ll is not

not study. we did we that line, first the announce closed for So

of from so from And this same others study. the course, of we PRIME the we as are the accept submission. expect, but is there submitted as based on the package the majority included, the you GSK the the package, majority PRIME But

Yigal Nochomovitz

navigating Okay. Understood. through Thank the your and of remainder best China. of in help you luck so and for crisis coronavirus much in managing the

Samantha Du

you, Thank Yigal.

I it’s the coronavirus the effect, to especially they on regulatory I the to and applause, the many team with business team and emulated side. major experts. on disruption side on really are this think Because both kick many have regard, regulatory treatment

Operator

Thank you.

from the your JPMorgan. have from the Anupam ask Please We next question of line question. Rama

Anupam Rama

I progress question. strategies Hey that guys, thanks you have development Thanks doing that potential also much. glad thoughts on for internal vertical taking the options options company. on to may that disease Any present business Congratulations hear the for at all the know COVID-XX? well the so and infectious company. at everyone’s an or

Samantha Du

all, have for and in of discovery in-house capability viral we however, opportunities. look an not bacterial. for do do also First fact, And we

we elaborate of been on Business Jonathan this turn includes Wang, will Head to our – Development which other other So those. over to more point. looking into long details we anti-infectives, have I

Jonathan Wang

Yes. Hi, the Anupam. Thanks for question.

a we China. that look evaluating said, anti-viral are especially in at both well in as of Samantha needs, opportunity large anti-infective think the have Asia-Pacific lot we anti-bacterial as as I opportunities medical unmet

comment – we of COVID-XX can’t probably we Although, on that opportunities a well. within anti-viral at specifically lot looked as

your answers question. that hopefully Some

Anupam Rama

our for Thanks question. taking

Operator

ask from We the Please of Jonathan your Leerink. SVB the Chang next question. have from question line

Jonathan Chang

my Hi, for congrats And progress. on the thanks taking question.

Hong launch could confidence the launch. the China ZEJULA you in Kong into for reasons question, color the translate successful, success that on provide First and can the any

Samantha Du

call. to I’ll for on participate Jonathan. that you And refer to thank Jonathan, time taking this the

Jonathan Wang

Jonathan. Yes. Thank you,

competitive top and launched year pretty mentioned, Opdivo, at that even Hong ranked drugs in As overtook Tecentriq after behind five oncology the presentation Keytruda, also end Lynparza. of earlier, first ZEJULA full months we among launched sale drug of Samantha was likes Kong and our of the revenue Tagrisso. And though in about and the launched its remarkable ever our basically we the XX achieved XXXX was

we So IQVIA the based on XXXX IMS market in over year Kong have full or share Hong now XX% for of data.

a that in Hong can launch having commercial in very success and this very situation, due able the that rapidly and as the replicate to the team is Kong that we to confident overtime experienced we China demonstrated mobilize in execute strong And are drug, think and the China. even launch has sales. having was very very rent-up ability So for the was we clearly coronavirus the China, despite I as best-in-class to in quickly success believe the primarily well team

was for launched was fact, the XXXX. products that last of were year, China in in in the January that only In all we approved December product

Jonathan Chang

you. Got it. Thank

similarities Second Optune the and and between differences can question, you China? the strategic highlight potential ZEJULA launch in

Samantha Du

Jonathan, you question. can for keep going that

Jonathan Wang

Yes.

it’s, licensing profiles. on our the best-in-class the fact, in with only the think cost. – it, of first-in-class, look if Optune, is I discovery at pipeline, we And you in case for in

pickup and team demonstrated that foremost, lot confidence. far, So have ramp-up of Hong told our believe geographies and many first of has probably Novocure so a all the that gives a people in the partner and of launch has as we is product, which location. that our strong launch terms And very Kong their out taught in us best has we in the been

included guideline very as in which streaming very patients China. option I there tell them. know for And is give national in in Kong confidence well that the the Hong that may you strong think the in the last China, year, Optune official should is that guideline, treatment available physicians and done follow a having is And us also

on these launch of approved. the back endorsement, So Kong about in once on physician confident as Hong the it's I all as with think of Optune well China positive very we're the

Jonathan Chang

Thank it. you. Got

Operator

the ask from Maury your question line of the Jefferies. Raycroft question. have We Please next from

Maury Raycroft

thanks everyone. my on questions. progress taking Hi Congrats the and for

First the question is on launches. just

Hong patients Kong any and then ZEJULA can starts the and specifics on for if in ZEJULA wondering Optune, Just in China? you more for provide

Samantha Du

Jonathan, you – discussion. take want continue to your

Jonathan Wang

to clarify. sorry. Yes, just I want

Hong You need products. the Kong in patient both numbers for

Maury Raycroft

Yes. willing provide to If if that's – that you're info.

Samantha Du

Okay.

not Yes. for Maury. Mainland from Hong also currently Hong patients have do in the We you, Kong. from splits thank Kong So China the and

So a split we that to yet. are position number not in

Maury Raycroft

ripretinib to And trial you and from just submit for how many the NDA? in study need Understood. results that bridging can to for will and that going the comment for in need if the that patients second-line, wondering order you you're study

Samantha Du

So correct me, you're not mentioning right, or fourth-line. Maury, second-line, first the

Maury Raycroft

That's right.

Samantha Du

Okay.

For of second-line, small contribute We patient global be with two either part – to do study, they we have can work or can to recruitment, choices. parallel global trial. we while the the global are a the our partner doing

So it go may progress, either we partners our depends on way.

Maury Raycroft

there? can quick the Got on omadacycline, you specifics question terms it. more And just Hanhui if last just are wondering provide is, on agreement with and the what

Samantha Du

that So to Tao. thank you. question turn I'll

Tao Fu

questions. your sure. Sure, Thanks for Maury. Yes,

for this really is we agreement. CSO us, mentioned, So

we one the anti-infective sales over be really in continue to anti-infective is to all right which retain China. grant any They exclusive of and leading the – regulatory have we Hanhui, reps right will MAH development So promotional or the XXX the in business. player right holder

spectrum the within has if community this that is it about setting. of view antibiotic broad really think lot product, you a And a

you really care So a promote primary product. sales need kind pretty large force this of

So a a building sales this strategy primary ourselves. versus we is force fast care go-to-market think

revenue, there will split their efforts. look milestone to I all mechanism receive payments promotional think profit a upfront related for as terms, payments be and we we So and

Maury Raycroft

Got it.

my for questions. very Thank Okay. taking much you

Samantha Du

add because we'd first on is anti-infective, that's care our Maury, Yes. a partner to a line, want Also why like social and family this just with the this. to work

Maury Raycroft

you. Thank Understood. Understood.

Operator

the next your question. Yang ask line of from the question Bank America. from Huang Please have We of

Yang Huang

to you is mentioned the we're point? on for the has on for in good earlier to doing you the I first elaborate Do know to taking on minded get really call, you Optune, everyone mesothelioma and road. great Thank is, second important progress which in all question and my indications you. indication that cancer. it’s lung Thank my think the question it further some that and And getting is congratulation

Samantha Du

you, And you Tao. I'll and thank the question for Yang Sure. your turn to call the thank time. for joining

Tao Fu

Yes. Yang question. thank Thanks, you, your Samantha, for and

we because get the it the is in you very know, very trying we're disease. as approval a lung technology mesothelioma really China do strong Fields it also is form and outside a to So brain. believe of well, cancer technology Treating the is that mesothelioma lung indication of important And Tumor And is as validation the validation. also approved and first

know very non-small close the very, success we at LUNAR So in large China and there year. for market believe do in trial well bodes to patients cell current really the that the lung the I XXX,XXX per and cancer

So potential Fields the Treating lung that’s in think really cancer. of we Tumor validation,

Yang Huang

Okay, question launch great. in my is about Mainland China. Thanks. And next ZEJULA

for going through So house, a right, a probably understand, I for channel the will patients from hospital as not yet. not pharmacy, the main ZEJULA be

can you able what's to kind your pharmacies goal how end visualizing or entered get can ZEJULA? Thanks. you to tell how So this you already by year? of many us many year-end for pharmacies the And of

Samantha Du

think answer for a very That's you. I detailed And the question. has good Yes. Jonathan

Jonathan Wang

that for question, thanks Yes, Yang. Yes.

You're right.

we Mainland to I are with fulfilled dedicated oncology but China, hospitals. products China in at have pharmacies, can the the sales the is are also But about the affiliated in you ZEJULA. FTEs what XXX are that when So we launched tell ZEJULA prescriptions these cover pharmacies

to of about our X,XXX these XXX in XXX well physicians about China Mainland currently cover For already. terms FTEs, And that hospitals coverage. up to in as XXX basically X,XXX they covers to

couple also wait hopefully reimbursement, important city So later onto for said, still the we inclusion think, while a we NRDL municipal this year. of I Samantha as got

And coronavirus So done lot a that we the already you a mobilized have work more confidence. situation China. of gives bit have and hopefully, in despite

Yang Huang

Okay, great. Thanks.

Operator

of from question [indiscernible] from Please your ask line next question. the have Credit We the Suisse.

Unidentified Analyst

small I for thanks taking Hi, only have two my questions. questions.

there why why put ZEJULA particular any is in-house First, for the some our – have second we and is, what much breast for is focus the my is expect not for segment these Thanks. And see milestones when question to that reason effort products we cancer. in products?

Samantha Du

question. the for you Thank

I presentation, you the think why this don't alluded breast Tao, we in in effort to cover our cancer. question? Tao’s

Tao Fu

Yes.

thanks question. So your for

extension GSK line on We are opportunities with niraparib. our very working partner additional for closely

potentially join and closely global them with work studies. to intend we So

is the served. breast think about of I cancer one being indications

Unidentified Analyst

product – some Can color development us the Thanks. me give in-house on effort? you give

Valeria Fantin

to take you Yes, Samantha, do want that one? me

Samantha Du

Yes, please. Valeria, and

Valeria Fantin

Yes, question. for the sure. Thanks

this about to our start going we milestones asking were and a key year. actually, You hitting when is are

builds terms the We into DNA patient are year details portfolio, will sort strategy and you be and immuno-oncology, providing as filings we’ll response the targeting signaling. some be repair these one that of categories, efforts damage, as mentioned from Samantha new IND three And proceed. seeing earlier, and overall our emerging internal in to major IND oncogenic fall of global more programs for the types two this of

also Samantha as will And they are are as there’s that exploring synergistic currently expertise. and you combinations And these we areas our clinical they three with for we have Because mentioned, know, are these growing the pipeline. aligned validation the with intra-portfolio prioritized. clinical three be in-house

So, continue this three way those is key in to very build areas. scientific expertise a to an that

Unidentified Analyst

Thanks. Okay. Thanks much. so

Operator

Please of your We have ask the from from the Macquarie. next question. question Gao Xiang line

Xiang Gao

out holding volatile is market. company our is the and presentation This have questions. Gao well the Macquarie. for in much from for our very two I Xiang thanks Hey,

update especially the one for EXTXXXX. anti-infectives, the is The is first what for the

a for going also drug category? have question just to is the that of the plan be biologics, that quite collapsed and with for is right? candidates we few manufacturing want of So, biologics, the So, company the know sales because to I what’s the manufacturing second

Samantha Du

a And question. Xiang. that’s good sure Yes,

core for side, small API is of to second the hospital be Entasis, we is the that about So, from manufacturing the work sometimes, always molecule our Because very so products that and different – see on we commercialize qualify especially more feel intend like project suppliers, do one We ICO and talking commercial supplies We suppliers. credible in-licensed – should that but do with from API for activity, suppliers; they are don’t don’t local ourselves. we API. also that the the supplier more the products. we do expertise, to

Xiang Gao

Okay.

biologics So, got down we for also use the the to road, CMO. some

Samantha Du

and PD-X margetuximab. also, one So, talking is the imminent far, the biologics, it’s so we’re the about

they those, will imported be For first.

Xiang Gao

Okay.

Samantha Du

we switch we makes during our do either locally local, ourselves, depends go then time. CMO, and on because it we time, to by expand facility capability that sense have can manufacturing and at the the we to can if to go which or

Xiang Gao

ourselves, if wrong, by Correct question, Maybe, I’m the right? a ZEJULA quick. manufactured Okay. maybe was follow-up actually remember just I me

Samantha Du

ZEJULA drugs product.

Xiang Gao

Okay.

Samantha Du

But again, suppliers. use suppliers, API, two do we qualified local

Xiang Gao

very much. Okay. Thank Got it. you

Samantha Du

Thank Yes. you.

Operator

of your Guggenheim. from question the Seamus ask from Fernandez have the line question. We next Please

Seamus Fernandez

Thanks for the question.

near guys So, if what you the near Samantha, And COVID-XX any the from maybe, think that thoughts people are there with or Thanks positives if opportunity are any just and any about then would that there a there’s you lot because coming Can any bit on there. little structural Deciphera, maybe, – much. long-term changes just talk questions of complexities to this. can collaboration are you know love here. of of I and issues on there? that linings there and if COVID-XX. again about if just of us and you two are are update basis, silver out for aren’t kind talk a and introduced consider timing so from if know inclined long-term potential But if to there there any envision a your of long-term

Seamus Fernandez

Operator, that did through. go

Samantha Du

Oh, sorry. muted line. my I

So, impact will you and as this expect sorry with data – study with and the regulatory a yes, submission expect fourth-line INVICTUS – breaking me bridging will on DSM the those in leverage and GIST China, do of in quick meantime, about to the do approval slobber combine nutrient. not let coronavirus the We we to will note, and to but we we data conduct product. short the together our And hold-on. really for part the regard thank

and long-term, always companies see has looking we I strong a we regions To strong answer also both the clinical medium very recruitment. so, but cells especially good a very your us, in term, unmet short term, having affected fundamentals, recovery, second are in disruptions see position. and some first-in-class in have coronavirus, best cash do in in think who we said like who needs in medical also China, question, But the the I and think the in for

than earlier, more Billy we have mentioned We have, as $XXX million in the bank.

us So tap to thinking to be able agility out more through assist that position out also in more and box crisis, get to this not global stronger of an to also put to changes. and efficient only organizationally more would but come – even have to

Seamus Fernandez

Thanks very much, Samantha.

Samantha Du

Thank you, Seamus.

Operator

ask next We of line from Nochomovitz Citigroup. Please your question question. the have the Yigal from

Yigal Nochomovitz

Samantha. quickly. Thanks very for taking the Thanks, follow-up

those trial study just a prior in tell were Just that quite one wasn’t recruitment Because but related regarding COVID, a the closed one asked given enrollment question and us in November, was which mentioned position, completed that recently it another fortunate I’d could to you. clear. I you you were? think studies you because Thank

Samantha Du

studies. for Thanks – we data ovarian mining maintenance Yigal. already is Sure, and stage The asking. second-line one cancer the in the the

one we So, it’s just year in November the the the therapy. maintenance in for first-line cancer recruitment last the closed – ovarian

Yigal Nochomovitz

for clarifying. very you Thank Okay. much

Samantha Du

Yes. Thank you.

Operator

[Operator ask from Instructions] of Jonathan from next question. your question the line have Leerink. the We Chang SVB please

Jonathan Chang

taking follow-up. MGDXXX, PD-X Hi. a for the different Thanks for the MacroGenics. specific on partner LAG-X with topic

update year. a expecting to pretty at most the study likely is drug We’re OB think on you Where expansive show this phase X heterogeneous ASCO this do activity?

Samantha Du

answer to like I question. I would answer Thanks, for probably the it. the Scott data Yes. package… before asking Jonathan Does

Jonathan Chang

next… the got I

Samantha Du

that unless package on from or Yes. us Tao. the coming data is have to Valeria some them additional comment want and this

Tao Fu

Yes.

better think filled to didn’t for trial a – Jonathan, our we question, prepared probably remarks in niraparib we cancer that gastric of I to in that had I MacroGenics it but answer not and MGDXXX combination have public. note we what So, actually it’s that’s

Jonathan Chang

you. Thank it. Got

Operator

now questions closing remarks. [Operator Samantha Du at the over I’m call Zai to Instructions] turn this back further Lab’s for no I showing CEO, time. will

Samantha Du

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

Operator

today. our conference participating. for Thank you you, ma’am. Ladies and gentlemen, Thank for that does conclude

disconnect. You all may

Zai Lab Limited (ZLAB) 19 Mar 202019 Q4 Earnings call transcript