ATNX - Earnings call transcript Q1 2020

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Operator

Good day, ladies and gentlemen, and welcome to the First Quarter 2020 Athenex Earnings Conference Call.

As a reminder, this conference is being recorded. I would now like to hand the conference over to Mr. Tim McCarthy of LifeSci Advisors. Sir, you may begin.

Tim McCarthy

for you update our well on review financial thank we call as and of of an quarter provide Athenex's results morning, for conference joining as a XXXX. Good first the business as The earlier morning news company's and wire the this on release results available the the website. detailing crossed is

this also be of on the replay A archived call will company website.

regarding milestones financial, of conference XXXX make in forward-looking statements will business year call, projections about statements clinical company During future the this and including the anticipated course fiscal and events, or beyond.

the you to that past encourage results with forward-looking materially We filings the described the cause which review or factors company's specific those and differ to the from identify future events actual SEC, in may statements.

filings or at SEC at EDGAR can section Relations find in Investor website in www.sec.gov at our www.athenex.com. our database the the You

by Financial Chief to Rudolf Officer; we Johnson Commercial Chief Sze, answer Medical morning, Officer; This will the remarks. Chief Cook, Tim questions Oncology, Operating Kwan, Dr. joined Chief who Jeff prepared available Dr. VP, be Senior Mr. Officer; Mr. are Global and Randoll Yordon, Mr. after Lau, Executive Officer;

call that, comments. With Johnson for the to introductory I'll over turn

Dr. Johnson Lau

welcome. Hello, Thank Tim. you, and

impact Athenex start time. across healthy the that of me challenges hope all industry, the has and unprecedented safe on across COVID-XX all companies. Let brought staying globe, that has pandemic during us saying is The at everyone difficult an had by and this about it some

time, safety today call. with health goal with impact operations, which minimal on have employees, the and core made to continuity further ensuring business elaborate and We of to ensuring evolving the adjustments this our the same a continuous of we'll handle our circumstances at

in cancer highlighted situation disrupted also that a safe patients care COVID-XX remark medical risk to I current has environment. need adequate and who would really the the

of environment therapies take pandemic their oncolytics, reinforced allow treatment in The advantages switching are this Network, as there to formulation. oral safety in an immunocompromised In to the is of issued NCCN, that oral cancer from or oral in Cancer fact, the available often the Comprehensive recently, guidelines it own where an encourage who version homes. treatments National has patients infusion-based cancer patients active

platform more motivated Orascovery bring to and market our for cancer we are Our the improving and therefore, than Athenex relevant is, at treatment outcomes ever, to in technology hopes worldwide. of patients extremely access medicines

advanced in regulatory to to the quarter now review. and the recent recent filing Turning and developments the of successfully been The in the MAA in two U.S. candidates application have or tirbanibulin for weeks. application Athenex and first regulatory in point lead has accepted. NDA filed EU

reflection NDA job. and a submitted regulatory have oral teams paclitaxel's in is the who track is NDA together our fantastic soon. done submissions a size. a major preclinical, of coordinated clinical efforts Having This a so clearly on accomplishment accomplishment to our of for be closely company a effort, Additionally, two capability CMC, is of and

pandemic means facing The companies. completions positioned have regulatory well favorable COVID-XX of timing some that to of reviews Athenex challenges other these to our of to and able the environment. trial avoid the will the paclitaxel is drug more normalized take been place due our a for regulatory business on no COVID-XX, launch oral expect interruptions planned we our be submissions in that There and

make to team key progress continues excellent activities. also commercial Our with launch readiness

we been supply advance launches. integrated of our investing company, to and been chain has well a Athenex have at build our and in team commercial in strategy initial Our vertically

details products our later reality. will make right as been Mr. paclitaxel of this the as Tim attributes goal the a oral this metastatic reinforced have market data conviction cancer. from exactly more Our chemotherapy to Cook choice call. clinical goal Feedback our in clinical the breast that on key well opinion and establish provide is leaders positive has as on to during research

two products. and the is launches planned supply of support robust fully Our to ready the NDA chain

secondary Our up sometimes, sources team in other has materials. lined tertiary API and, of drug

experience minimizing chain due to supply in been interruptions Our team's to COVID-XX. extensive instrumental our have and titrations

API resumed plant operations as new plant facility and Dunkirk has as API existing China construction Our the is in well China at continuing. our in

to operational resilient on capabilities execute according on Nevertheless, are as our Currently, plans our uncertainty we in business our are have evolving continue track. strategy. to We and and situation. that calculations recognize persist, we continuing we adjust the confident remain we build made a may long-term to the to

to Chief Kwan, I provide will Medical an our now to our over Dr. of programs. Officer, the overview Rudolf Rudolf? clinical turn call

Dr. Rudolf Kwan

that In are Johnson. NDA filing. FDA filing indicated currently you, actinic of all important an December a and the application Thank and date for Athenex of timeliness The company's the the marks NDA committee. provided This accepted is XXXX, data in we pleased the early been advisory of a it for is tirbanibulin U.S. for on have an achievement by The announced FDA. has March, first and keratosis. involved, great manufacturing the the speaking does FDA to review milestone the the that facilities PDUFA report of XX, holding inspected This as on submission. already we teams that not track, NDA our plan the to robustness

strong team Europe. validated This Almirall, in also on was submission generated regulatory package Athenex. the at EMA a our based by The partner, data has filing by the

actively of both for in potential are tirbanibulin excited partner, Europe. for ointment preparing our commercial Almirall, AK the U.S. is and launch the We that

Our April, discussed submission a package. paclitaxel clinical meeting oral NDA is early we imminent. had We our for productive FDA where in

have represent as and steps for prepare meeting one with we We this agency, submission. final dialogue the the in of been active

on becomes will on also FDA's when survival an available. endpoints, response the further and In the meeting guidance official of FDA, update further submission we We our with will assessment provided the when it's provide with communicate agency us the appropriate.

indications, metastatic combinations. breast of we cancer, several paclitaxel of in clinical the ongoing to Oraxol in the strong III in addition Phase studies In data seen have including additional study oral

in on of will a been be open-label II has study update ASCO at discussion May. for next paclitaxel Phase our angiosarcoma, oral session in which Our poster accepted

data we from As this reminder, early reported in XXXX. a trial positive

steps clinical like and has impacted have following pleased We protect the trial a at this the clear is a studies variable are in interest cancer. in and angiosarcoma local have trials guidelines with to majority interrupted and taken other look recruitment forward patient's COVID-XX ASCO. is of extent. unmet have rare industrywide, of that to noncorporate need we given the this providing update disease, health a and range necessary providers. with There and the an local to We, been healthcare been companies,

adjust and provide we'll appropriate. as situation, the continue to updates evolving to We

immediate to the approvals and oral for achieve Our both paclitaxel submission focus the remains paclitaxel tirbanibulin. of NDA oral and regulatory

completed We some Phase III considering current candidates medicines look believe pipeline. all these environment have have are We innovative to the and fortunate the the studies do we to not and regulatory delays submissions, in COVID-related the for important any processes. product currently to forward anticipate our practice-changing advancing

in the thank and like be the to two to this. NDA clinical work gotten take time the accomplishment us to which my position by in. close a fortunate performed In team submissions major contributions I to achieving point is together, very would has for closing, their so this team of having

to the turn these to Cook now Tim discuss that programs commercial Tim? opportunities I'll represent.

Tim Cook

This an morning, everyone. important you, Thank for Athenex. and is time good Rudolf,

cancer. oncology. a on preparations preferred is strength San are paclitaxel. we an for finalizing This are data our of presented successful of to breast the feel well the launch Antonio, our in strategic clinical metastatic in We in of establishing chemotherapy we goal leadership positioned first Building step oral at important our busy achieve becoming

is changing. that Oral an has the paclitaxel exciting potential to be drug practice

have as as superior rate and shown neuropathy. Phase study III We response our in survival lower also benefit well a

reviewed clinical spoke the excited the encouraging the about further from results, team that feedback are of who by experts the clinical is data. to, we U.S. and Our most clinical driven have

compelling. The market is opportunity

market oral mostly patients will annually approximately patients are or negative. paclitaxel This hormone in who for are the Our represents shows triple XX,XXX HERX-negative that breast who cancer be U.S. positive, research prescribed

endocrine chemotherapy is know also metastatic therapy, cancer, preferred. We after chemotherapy in single-agent and CDKX/Xs breast is mostly and used that

So commercial very prospects. are we enthusiastic about

product we Athenex level benefit now to indicates breast conviction oncologists our in oral clinical the Oncology greater is physicians finding candidate. year, also around IV versus attributing preferred of awareness Last cancer. conducted market of Of March research about of in now validates is track these, XX% of metastatic of XX% are or latest knowledge chemotherapy majority having physicians are some are our paclitaxel There This because on becoming Athenex the it with capecitabine. brand. established Oncology. paclitaxel, the aware that The important that we

physician to know, the and than for agents Orascovery believe platform technology COVID center. that an is has As interest increased pandemic require both we and travel Johnson oral mentioned, ever, in our infusion that don't example, we oncolytic now more patient relevant that

research Orascovery that to across indications oral products there breast agents other to paclitaxel launch this board to pending but favorable in of awareness Our platform. believe treat not the could our us the that utilize We tells use the in pipeline increase been a XX% and be has the tailwind, of a only cancer, cancer. that also oral our oncology other

paclitaxel the point, has well of characterized. this oral been profile At very

team combination We both life evaluating prioritize treatment. including are and the to with working plan, the monotherapy indications, future clinical closely cycle

on with and maximize that this potential to to many So capitalize opportunities of value are there drug. promising we plan the the goal

are previously planned with activities. with world. work as connectivity our of our that's in prelaunch well today's relationships and community strong a company the stakeholders, of as with we business on And This conduct track oncology the this as possible virtual environment most remains result in various to able the

We our hired half and launch. still team we'll an onboard in group the sales team We are confident our the in our and to year place medical of second in team and advance paclitaxel have experienced on oral are science recently prepared rounding of leader. plan out base

group XX launch. to supplement We six months three will this then hires post with approximately another

pharmacy on with closely better receiving We distribution model ensure specialty distribution specialty our and more have pharmacy to us compliance. selected providers. treatment strategy our believe We that and accessibility allow and interact this patients drug will converged

turn good So to summarize, company harmony We've terms this about and and work to to where a the pipeline call we and products. result Jeff. preparedness. I'll in progress between get to as the success teams able our exists now point we and partnership the of feel commercial R&D, been clinical of commercial the to paclitaxel is oncology together very that of the over as oral subsequent maximize

Jeff Yordon

for to Tim. chain I'm going as talk pharma and about compounding well today: our manufacturing areas Thank two supply oral paclitaxel business. as you, specialty our

that those vertically integrated. is of by to from strategy will have Let build our beginning following very company you who the begin that that is me Athenex appreciate oncology saying been an

proprietary our product sure been are We've this But goal deal our better this handle it resilient we're elements to also have have events. to ultimate the in COVID-XX. the model put working maximum been manufacturing our diligently position us doing believe place launches. and the that capturing means from in of We unexpected of commercial with value in business a well to with for that make resulted I very shareholders. necessary has stronger challenges importantly, is and prepared advance

to chain, of this a regard necessary With for the paclitaxel, flexibility for and have backup oral established we part a support chain providing seamless plan launch. the for supply every

uses. in Our supply to and for regulatory in Polymed Chongqing March our the resumed facility operations clinical API

We adequate inventory and have commercial enhance to the are an continuing supply us of to at manufacturing launch time building our of will processes. are allow that amount

interior York, New Dunkirk, The exterior in are facility finished. now is substantially complete. Our and

We the be will out. have fill that this some to of used ordered equipment

injectable We sale proprietary facility. our manufacture to at this and expect XXXB eventually and commercial products our for products

our to spec have product business, COVID-XX. XXXB Turning we to to hospitalized for and used mix who order treat produce pharma adjust been patients recently in been to our pharmaceuticals able have

we As essential there the the a certain the to manufacture capabilities hospital a in dramatic demand and many of existing these. been has have result increase for of pandemic, products,

markets in markets Athenex We products are XX and currently include XX Solutions the piperacillin/tazobactam. products by now of being Pharmaceutical treatment Pharma SKUs midazolam are supplying that XX Athenex COVID with SKUs. products azithromycin, five used and several and Division These hospitals patients.

therefore, them this We terms. costs introduce of reduced directly year. continue to us benefits Of recently, note, be and, order customers will our new The seen will to products trend to fees allows payment in our us. moving have a which and shorter from online to some lower we portal

the turn Randoll discuss to over me the company's financials. Let call to

Randoll Sze

of sales the decrease sales $XX.X Revenue quarter compared XX, to with suspension Thank of you, Jeff. the product were decreases $X.X sales vasopressin $X.X due to million in of by attributable comparable million an from decreases associated million the in XXXX for product March $XX.X These was new respectively, in product products. API new API increase period revenue the launch XXXB primarily was our in XXXX. million, two ended sales. specialty and facility and and and with discontinued offset This

In for XX% a was million, the million the which the and clinical decrease in was December XXXX. million fees for license as first recognized decrease XXXX. related into of XXXX. totaled operations. attributable first million and entered approximately quarter, $XX.X the primarily in the XXXX quarter R&D the agreement compared period licensing we reported Cost in the to million quarter first expenses revenue, $XX.X due to totaled $XX.X $XX.X for compared quarter sales a to Xiangxue licensing in costs comparable to preclinical of This with first as to $XX.X

for $XX.X This to prepare of proprietary administrative and quarter increase including service drugs, general first quarter expenses. to our of approved, fees for if to the million commercialize primarily $X.X expenses million SG&A was first the due $XX.X and operating million spending compared expenses, XXXX. with of other of million $X.X the an were professional

of last year. loss $XX.X were XXXX a compared million the result first period quarter million the in $XX.X foregoing, for in same As the with operating

as balance expanded York our quarter. Net equivalents short-term the China, QX at revenue New XXXX. investments XX. our our QX to payment cash include from to impact share an a was $X.X in payable that Athenex that million $X.XX do million in in to partner funded were license I of in $XXX.X not Cash, highlight by facility of the did $XX on partner the loss the net $XX.X this that taxes due March Pharmaceutical, but And earnings. relation want or had China compared our to license payable and in included million for million or note $XX.X million recognized with totaled attributable Xiangxue are from State agreement. per there receive we're $X.XX construction part This first Dunkirk XXXX

In affirm be growth XXXX. sales million we terms year-over-year $XX.X that, in of from product we product digits guidance, sales XXXX expect the mid-single in to

light operations COVID-XX in guidance that discontinuation sell of last product and like We had to taken treat the would our the to for are currently vasopressin at we not from and suspension account Our at has and sales of We may meaningful plant to that March of generated of together activities, XXXX. we operations which as our short-term cash to view in Taihao year. XXXX XX, these have into our XXXX, recurring contributions our and time. products current COVID-XX into pandemic, patients. used investments sales enable to us do API revenues in note cash, nature, sold based expect appropriate QX will be the as we'll operating fund continue plan, provide with on XXXX, operating cash update our And our current equivalents an

from in XXXX. China, are Pharmaceuticals, for forecast, Xiangxue flow in have our cash license cash to contribute which meaningful expected payments inflows accounted our In we partner

will now on I For our the remarks. be Form financial read Johnson details our the to call you SEC. encourage more turn to closing back I for to with filed XX-Q will results,

Dr. Johnson Lau

Thank you, Randoll.

mission to make on be leader our fronts Our oncology, continue is at in and success. Athenex to future a novel to drive we progress

tirbanibulin oral strong pipeline. of proof-of-concept the very establishing program, with in Orascovery robustness us as continue ahead of generated for positive have to repeat even early respective established crisis will I'm of care challenges. company. indications. their with And clinical to there of new fundamentals. our opportunity plan across as to believe Athenex our and any result looking executing focus we is in data to has deal our our paclitaxel that success broader in organization an and to We year standards enable for the team our that I'm will a confident according the forward times experience well and remarkable now

We will Operator? questions. call now open for the

Operator

question we'll from now And Robinson Karnauskas our SunTrust first from take Instructions]. [Operator Humphrey. Robyn

ahead. is line go Please Your open.

Minh Vong

everyone. Congrats very for Sorry. This on and positive the Minh quarter meeting. Robyn. is congrats FDA on on Hi,

really Just quick three questions.

you familiarity physicians chemo? oral any with or surveyed? I'll guidelines one, paclitaxel I to the after? color whether many inclusion guess, to on sort survey, before And from more can one, to And they to use the how given one guys little then, Tim's any for provide large like you a survey the And COVID-XX? of have for guess, as switch oral, you chemo such any second physicians prior patients have had then IV getting seen surveyed was? oral how first if during the third NCCN criteria, save using requests the On just the I getting

Dr. Johnson Lau

Okay.

the For an do Rudolf, with update? you regard requests during COVID-XX, want give first to to question

Dr. Rudolf Kwan

Thank talking regulation Yes. we have do received on the are and that and request, you, about. we the Johnson. it, depends the dealing institution in obviously, and Yes, in with we're country

turn So I'll yes, survey Tim requests. to Tim? we for have these answering question.

Tim Cook

number physicians, breast actively had The approximately Yes. cancer they to oncologists. survey, for survey the metastatic was patients. And to treating be qualify XXX

feel we practice. So pertinent information and highly that the to was relevant current very

Minh Vong

powering overall all, whether in what is And last in that's. trial accepted looking and discuss or impact to waiting just the have guidelines provide you about wave whether not, decision? I FDA they're little the mentioned had survival in not decision but going Rudolf, because what to And making you're or to on their for the survival can would whether color really the that a include Great. you digital the the been overall one know at not? talk

Dr. Johnson Lau

Rudolf?

Dr. Rudolf Kwan

Minh. you, Thank

paclitaxel the the pivotal on response for oral was overall study designed over superiority As based IV paclitaxel for we all know, rate. study,

very positively. up that extremely were the we came results So happy

the survival, happy were survival. at especially rate, in analysis even it, that outcome with ongoing in response consistency overall we with Along an the the very, the look show very overall consistency the survival we in and at

So analysis basically how survival, from the the assessment. especially overall the this and the FDA, risk-benefit survival. with And this guidance obviously continue will survival part be survival inform was of us discussed to analysis overall ongoing of ongoing they us certainly, that, gave the they with

the once appropriate at of indicate, we time, as the So communicate we'll results update. this

Dr. Johnson Lau

so and quarter. Okay, thank again congrats on the much you everyone

Dr. Rudolf Kwan

you. Thank

Operator

from take from Markets. And RBC MacKay now Capital next we question Kennen our

Your ahead. line go is also

Kennen MacKay

meeting. was relating And for Oraxol? to the for submission NDA on with final of gating And progress. sort final just here? what taking meeting sort you NDA Wondering, if of question had if from that the if last your not, the received Congrats thanks maybe my Hi, that is and to the FDA, what understand gating the is minutes submission hoping

Dr. Rudolf Kwan

Rudolf the Kennen, and the we us. the here. feedback based the Yes, receive was indeed, submission very track did FDA meeting and is provide on minutes, meeting to constructive, on the

Kennen MacKay

is shifting a to Is yet? to maybe then prestigious talked obviously forward meeting going FDA path an of investigator-sponsored a are you with these Wondering the really presented And or there. be data that again. blueprint up. This registration-enabling about have a coming And is at there? pathway the angiosarcoma. trial of Congrats a sort what Obviously, there sort trial. toward

Dr. Rudolf Kwan

high angiosarcoma most with a very medical population, interesting is need. very also whether IV Kennen, represent oral. tolerate unmet elderly the an mind, ultra-rare not disease in does be Bear it a in chemotherapy, or which this indication,

as very the recruitment happy is previously, have been that very and we've happy tolerable very indeed by active in agent such that very this the studies the are population, a we we elderly very early So articulated results rapid.

encouraging a indication. as regarding are the of to amount would pathway and approval will new in late results saying, expect And the say data FDA these in the hear talk of we for new May. data keep the really data us, I to this to additional fair ASCO we you presentation So,

Operator

from And & now from next Messer Company. Needham Chad take we question our

Your line Please is ahead. go open.

Chad Messer

us for morning, excited put out us company, can remind you Obviously taking the you your Oraxol. But market at Good in you just very in they just actually they're know to Right. they're marketing of their what U.S., commercial through was is about my a have tirbanibulin take and for wondering in with even Europe for But could Almirall, I what capabilities there forward if closer thanks about preparedness. question. hand. products. of already the product? I can sort

Dr. Johnson Lau

they according been the both good regard with the continuous to Sure. through a them Almirall marketing. clinical as Steering to launching has and for Joint dialogue the both schedule. And for development with are on well partner, as Committee track we product have

quarter indicated be in ready Specifically, they during U.S. conference And quarter the of second to and in that in product call, XXXX. XXXX their of they the launch will first preparations of Europe field. the progress. the all they one then largest In in Europe, in then XXX in U.S., have are than Europe. derma And company more this they employees in are in

and these available all also earnings in their that So and their website. results call are are information

Chad Messer

well your When the comments in times these When being docetaxel more we I on last Okay. well? products? on we of as Great. we ASCO since pipeline updates that got on been, some that expect oral and more And on even expect other taken. irinotecan. chemotherapy updates the It's can oral think, can relevant are current program the some

Dr. Johnson Lau

Sure, Rudolf?

Dr. Rudolf Kwan

and active, a along variable been on all are COVID-XX, programs going patient has we are something. articulate The be those there Suffice results the say, when depending to on you're you the Chad. ongoing studies speed. able sign and the the as will full very with Obviously, Depending site ongoing, that which tells we are a population, Yes, for is impact. go moving good we still it preparation, along. to MTD,

phase start have is once piece we the on the second of ready that of currently we are course COVID-XX The next with some are off the to impact actively sites ready.

to going risk hear ready information forward. as them we the additional are release ready to be So,

Chad Messer

you. Thank look forward Great. that news right. All good the and, hearing to Oraxol to on course, look of I program. forward

Operator

next now from we Oppenheimer. Kevin from DeGeeter take [Operator Instructions]. question And our

open. Your ahead. Please go is line

Kevin DeGeeter

taking I thinking part we us post to plan how you of travel increase or experiencing argue you what launch. reduction walk investment? just portions about and appreciate early flare-up be the launch you expansion way? that if a infection or and Hey, on rates really mission continue are And receive in a longer-term full to thanks questions. are launch which the COVID-XX of were on would exercise should in my for Can granularity in adjusted restrictions really in through of travel, preparation Tim, material thought it kind of central resulted that would the

Dr. Johnson Lau

Tim?

Tim Cook

Thanks, thank for your Johnson, and you question.

a environment highly We currently of like in. situations, restricted variety a we're including are for planning scenario

So we're we did reduced including in multiple last We prepared over our we virtual felt that year, to more of shifting to launch restricted a environments, one. because it a was lot began Early cost. the world. work it efficient and

So work in the to unimpacted to we've been world. work able the continue last of did things of virtually because all our we moving year virtual

our And to to so would putting infrastructure very to started in COVID customers customer process. if virtual we in are we've space, relevant, still up of allow situation that our us management, where our in and digital through we move through virtual the engage real-world setting most relationship already CRM, that a space is efforts actually to

It's engaged they scenarios. We're and and watch the environment. for them very launching feel we are learn how an in can preparing multiple companies watching are unprecedented learning this we and now, like from in also very unprecedented right environment. we launching that are So drugs

ready. hopefully, it's case more But in So infrastructures to various normal the a for scenarios. that put already of in we're for restricted, prepared we return all begun place. the this, those again, are And to We've we environment.

Kevin DeGeeter

Extremely talk, then helpful. And please Yiu-Nam.

Dr. Johnson Lau

receive environment, to that or oncologists. hospitals in Tim's that good all the we And are of patients very to key clinics. hospitals the this regard that feedback very opinion did to leaders they calls team to go I lot a very, available, fact, from the encouraging in for all for add fact paclitaxel if a And are and to for patients multiple oral comment important that with also not also to fact adhered will practicing is be consider. want these

Kevin DeGeeter

COVID, driven sequential sort follow-up And was as to, provide bit a There certain paclitaxel granularity or programs oral may chosen R&D. expenses the reasons? been stage significant more item. a in little due more you breast from then you have for from the that III of Can of housekeeping other cancer? a to program metastatic roll-off spending helpful. decline to or just of as the preclinical Extremely Great. Phase on a to, either for bit largely Or was early forced that question, restricting for

Dr. Johnson Lau

Let question expressly. me answer the

the data on the studies, even regulatory have are for filings on completing we'll mainly studies clinical we the of pay dollars submission. the and sure are post complete. and a couple expenses spending the There making on focused regulatory were the million spending Our were most on time, the process based sure all on making all NDA few also a that FDA that submission just to complete

So most earlier-stage programs. advancing. also are studies the for programs critical clinical expenses of and were to also the support the regulatory The

more data will then down But update we provide them. programs available. when supporting COVID-XX it I and still are situation, have the We slows the clinical earlier bit, an a little

Kevin DeGeeter

Thanks taking questions. my much. for so Thanks

Dr. Johnson Lau

you. Thank

Operator

we take next Laidlaw. now Jen from from Yale our And question

ahead. line Your go open. Please is

Yale Jen

taking production that might for My bit that's what first a questions. about is us capacity thanks So color you of the Good doing well. products. my morning plant Could and give for first little capacity question the hope is Chongqing everybody I question. be? the both

Dr. Johnson Lau

you to mute. might do the Okay. answer be Jeff, Jeff on want question?

the question. answer me Let

Jeff Yordon

No, I question, the can answer Johnson.

in that, set. any launch our good that in API a production options encequidar for back our if of than We're We support any are working. know, also The case even shape have place material, to just enough the the has the both date, should all in very, government on of continue. I launch and we're third you And in raw we of agreed the can as enough problem, all have that's take programs. have and now, earlier Right will clinical programs clinical we second were paclitaxel. NDA anticipated supply add very on there and we Chongqing. is local that the

So we're in good shape there.

Yale Jen

maybe That's question housekeeping Great. helpful. come. a regarding the from China And to very payment Okay.

First, is kind of And be some shot that then wide just will payment? this when that or amortized payment might a for be? secondly, if

Dr. Johnson Lau

you. Randoll? Thank

Randoll Sze

Sure.

the license of to was the payments arrangement actually we coming So and to if April, in in the in start majority, in, booked not anticipate relation all that payment, in in receive of QX. terms China, the revenue in QX the

amortization this no there's So revenue to recognition.

Yale Jen

maybe the question case? Or which ASCO that here, be the tirbanibulin, is last the And that's for Great. meeting prepared? Okay. there to not is an

Dr. Johnson Lau

Rudolf?

Dr. Rudolf Kwan

indicated do holding they advisory Yale, the committee. currently on not plan FDA

the will they think decision. absolutely, clear But I did in think, for make it. of that we not an prepared for the meeting. submit in them, planning ASCO to a to are us, indicate set they So, be they have them it's if case ask letter, very I to cut we strength the data And

Yale Jen

Maybe Okay. one in more just question. sneaking

rolling the terms you review a something of NDA? later on? paclitaxel, will Or that's the would In submission for that oral be

Dr. Rudolf Kwan

of We question a we a information. that you with full incomplete The really have complete in rolling have submission. information believe go is to submission

the endpoint. other the at continue got to hand, On to guidance we look survival

So the with certainly, discussed that is looked be that FDA will be a going point how to at. to be

that So appropriate. when we it's articulate will

Operator

And from Ladenburg Matt take we will our next question Kaplan Thalmann. from

Please Your is line go ahead. open.

Unidentified Analyst

that how that the progress. the shifted question on all the you Thanks in Raymond wondering of guess side the for NCCN guidelines, commercially Oraxol. my was just some changed has launch is you. questions for Thank commercial I perception? perhaps Congrats. And given has This kind taking of Matt. payers' about I

that box businesses? For same

Tim Cook

reception. feedback pleased with market from we've we have The the is you. us how highly us been see see and They research product. a the been Thank replacement been conducting the And They very as as a by unprecedented, Yes. certainly they They and and an receive change have guidelines taxane. as payers, for frankly. NCCN innovative are terms quite product. of encouraging in a will already extensive see the don't us innovative in

be challenges. won't for us. see over see us numerous there X/Xs. know But and highly exactly mean and We've a they payers the innovative we've the they we doesn't last CDK committees, how to engaging advisory year, that similar had been as drug Now

clinical and patients be decreased of in I in strong guidelines that increased environment. top We and that physicians It due enhance think rates, add safer for the So, survival, have in new overall think to position position are us will gives a in the looking really We strong you puts profile already of a that then And allow at response that terms position. home of neuropathies. options really don't are fact us strong that on overall that. very very really strength. increased them we treated the it a a to

Unidentified Analyst

Okay. about Fair you maybe enough. been cancer breast still for a Or of have of kind terms is follow-up that perhaps as thinking guys strategy that, to And preliminary? commercialization? too metastatic beyond in

Dr. Johnson Lau

the do we FDA FDA. now for Tim, want approved, breast conduct with indications cancer, We the The And only the that have that? metastatic approved approved marketing the submitting guidelines the approved activities to by to conducting guidelines, to in current that marketing to fact we're will according package anything the be and regard appropriate indications according U.S. of to follow top according you when the projects. efforts the to on appropriate add we

Tim Cook

know, plan. Sure, we Johnson. on R&D closely we're our going and I life add working already would And you a to clinical put angiosarcoma together as that cycle areas. and trials with have in just other robust teams really

will cancer be for in right on our we continuing preferred successfully the to establishing now, launching breast and focus next metastatic analyze our is chemotherapy patients. ourselves opportunities. Really, those So as

Dr. Johnson Lau

say we indication think we really to the and you paclitaxel. be believe with in will combination of be also potential the appropriate And potential unlock that set paclitaxel label thank product, of conducting of lot oral our as biologics clinical able use, fact question. value oral well combination support with your expansion to of the we we to about be to and to for studies as to also which this regard will a the evaluate conducting whether the clinical if obviously, therapy, I/O of expand Suffice will additional studies the that you

Operator

this are further closing turn any to appears conference time. would questions remarks. It at additional I there for or no back now like to CEO, Lau, Johnson Mr. the

Dr. Johnson Lau

this forward Thank team to this to you. all very been for submitted major time. especially you have for reiterate Thank your working say are ointment thanks is on time. to excited NDA our morning. second and this tirbanibulin company size, for a a that our of all would Bye-bye. to our time major hard again I accomplishment want who during for unusual I to We're ensure milestones have paclitaxel medicine. our first like look NDA to to oral the

Operator

call. today’s you concludes Thank participation. This your for

disconnect. You may now

Athenex (ATNXQ) 9 May 202020 Q1 Earnings call transcript