ATNX - Earnings call transcript Q3 2019

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Operator

Greetings and welcome to the Athenex, Inc.

Third Quarter 2019 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. to conference like host, to now Mr. would turn over the your I LifeSci McCarthy Advisors. Tim with ahead, go Please sir.

Tim McCarthy

call results the news on A Athenex’s as and website. the our quarter wire for we on conference will morning the be call this as Good on crossed thank this XXXX. as archived provide you third quarter an The financial review also release of website. a for of detailing the morning joining business earlier results well company company’s replay the third and available of is update

company’s During company fiscal regarding in which the and the statements. or the and course future cause past with differ events of may that make statements anticipated this in the milestones year identify factors conference XXXX financial call, forward-looking actual from filings about SEC, results the or forward-looking materially clinical will the to and events, future to beyond. you described specific statements those including encourage projections We review

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

Randoll and This Kwan, Yordon, will Mr. Medical Chief Dr. Chief Officer; answer prepared Johnson are Rudolf by be several Officer; questions Sze, other Mr. to Chief executives Jeff Executive available Operating Officer; Financial joined morning, Lau, the remarks. we Officer; Chief Dr. who after

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

Johnson Lau

Thank you, Tim. welcome. Hello and

bringing the pharmaceutical We closer have company. continued board becoming us a to across progress integrated strong to fully global make

For be guidance pleased XXXX. raising to the full-year we sales time for are second product year, this

markets. upcoming two XXXX, follow NDA we and oral an including Cancer filings in global filings Meeting We to encequidar and catalysts oral anticipated have upcoming, Breast major data expect regulatory additional the at Antonio of in paclitaxel San with which early presentation several

in the very potentially are therapies advance We multiple to strong future. successful position the also in

our opportunity in drug strategic development. been building potential commercial our operations of maximize candidates to managing the in have and We resources

looking products. are for beyond the we and our advance, to get to labels continues pipeline best ways and current for broader our As indications outcomes marketing

market encequidar, we are proprietary As commercial product, optimize prepare to first our oral to infrastructure. oncology we our making progress and expand significant paclitaxel and

to expect once product approved. with make this well impact significant a liberty We it’s be in to prepared

registration paclitaxel the of oral oratecan, clinical from August a support to breast discovery as profile eribulin. Phase platform for for are metastatic strong Operating working body become significantly data – the paclitaxel follow, efficacy brand, Yordon our evidence oral of profile successful to will discuss strong of major discuss cancer. and recognized preparation and Chief as to very U.S. as successful, topotecan comparative a our the with be Mr. cancer. our in including adequate Based with and part this safety continues our the Officer, both demonstrated oral has the outcome that The perspectives. ongoing and our FDA study, reported previously become study, oral is of positive Athenex, This in As new brand differentiated clinical X who preparing major was encequidar product target Jeff to oral our the adding Oral oral it oncology X build de-risks could Athenex a Currently, the the commercial that if trial a docetaxel, on global paclitaxel with raising that single approval. flagship that data of designed. we a will upon clinical indicated target products milestone programs oral player Phase commercial we

XXX compared in to IV compared were oral IV as and paclitaxel paclitaxel. This overall paclitaxel, days oral paclitaxel also on frequent factor. is study responders confirmed significant Neuropathy to differentiating much of with important oral greater was proportion met in believe which than greater its versus an trends There strong paclitaxel, of overall duration IV we primary response a endpoint improvement statistically survival well as with less rate progression-free showing survival of paclitaxel. response

of to cancers highlights and pipelines, Importantly, cycle develop oral which the range this as product we of management. expect a our potential for combination of chemotherapy part clinical outcome life approaches

with Our keratosis, consultation second top XXXX. tirbanibulin are the our with in year. filing ointment first and results positive FDA in quarter the an NDA March Phase completed line for the which of for in the is process report pre-NDA this finalizing we Actinic treating for X of submission anticipated We

are product and Almirall, is Almirall development are We for excited of partner patients to application serious our payments this partner in to we are actinic milestone preparing Almirall very launch Under and with sales also who need with and the effective our for commercial submit in agreement eligible Europe. Our therapy. market royalties. authorization keratosis

also our the value chain. across to functions our I highlight want effort supply to ongoing integrate capture and core

and of products We proprietary are our manufacturing the expand both clinical which will pleased terms Jeff that around global our Athenex continued footprint, discuss. for capabilities world, in has our customers for and and to

commence anticipated larger half and new operation and completed China in Our of API next first to in year. construction plant is

We allows with CIDAL in October from many And they to of overlooked been with number to been us patients trained the conduct capacity bring globally strong taken Athenex’s that’s assets have and come. infrastructure, acquisition for were big population the clinical the marketing be XX. a trial the has maximum development in studies deliver clinical companies, growing global traditional a value of pharma. high also fierce. Moreover, draw of report in to fact support America expertise. are Competition substantial in big on by so process. believe enhancing are Europe position UK Latin sites and to expanded These decision pharma closed establishment our become over regional by of our we for of of initiatives goal enhanced the in subsidiary clinical have region. U.S. this Because the global our in years Having we’ll we that clinical the the we growth CIDAL R&D capacity new colleagues delighted American a and quality, Latin to operation

Daniel announced Senior and Axis Development Investment Therapeutics we also was appointment previously quarter, of the RS Lang lead the of operations a investment, of for Lang over Dr. Dr. during front, as Director Athenex. the Investments. of Chief act of Corporate of leadership the and platform President has Officer management as the immunotherapy Limited healthcare medicine, years well to as T-cell XX as our On business experience. He

We welcome are business. to and his forward for exciting of and part insight look our delighted leadership and this important him to

and value, put increasing our really over, at as further matters, to reports from on which in were of our you clinical X business committed if management subsequent have the do governance. pipeline vast not developments recently well revenue to as before want conclusions. we We guidelines team, and two want remain Athenex subject, intend programs call reports turn as corporate focus far, we Finally, focused source integrity what of our on that to and successful progress. strong pride on XXXX. and so entire execution, making the our record same track We been issue I point, twice and the I discuss At of company. significant and unfounded published comment on take Phase this These the to accomplishments, information, experience misleading importantly, and our inaccurate this look the several contain delivery including in and is we are we

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

Rudolf Kwan

you, Thank Johnson.

previously our reported first candidate, confidently on ahead moving our encequidar. discovery NDA towards paclitaxel our are for oral lead based platform We data submission strong oral we and for the

primary in tumor patients. of XX% X.X overall for the XX% As breast paclitaxel paclitaxel X.XX. cancer monotherapy of patients patients compared our ITT is response improvement and a of on over based IV rate terms confirmed criteria of was We very endpoint, showing response. significant paclitaxel the based There met compared with response statistically metastatic study to showed multicenter involved benefit IV study reminder, and announce endpoint confirmed for RECIST the whom randomized also oral This p-value to a to with recommended. analysis, duration an were was product intravenous that excited in overall XXX paclitaxel rate paclitaxel in its on

we As trends strong detailed both survival overall on that and last survival also saw favored progression-free for we our call, paclitaxel. oral

chronic paclitaxel an class this treatment IV the for be oral versus We the for safety are lower is of of paclitaxel. can results we also grade irreversible. milestone versus and particular, study toxicity Neuropathy represent saw this overall, Collectively, X% neuropathy, XX% neuropathy new profile limiting XX% drugs. of development a pivotal in much In for paclitaxel, free pleased very with the and to dose anti-cancer important oral X%. IV major and the compared

paclitaxel’s we safety Phase it patients oral has the in to competitive compelling of efficacy become of will the on the believe Based and X in We clinical benefit results, evidence cornerstone cancer. metastatic treatment metastatic breast potential with see and be for terms the a breast cancer. of

Breast efficacy As XX. deliver our find top an plan the on X results and the of will we physician update. oral Phase and We results We scheduled we that this presentation information San safety forward Symposium the believe additional look in disclosed, are around compelling Cancer we important data the to to to at line Antonio December reported August. share community

in submission the for complete oral currently quarter first of are we next meantime, expect paclitaxel, our which the In to currently working year. we NDA diligently

provide expect We filed. the NDA been after update another to has

will the and discovery Importantly, the platform. terms of beginning we oral we demonstrate expect is believe way this our in paclitaxel oral for only to

in is Part angiosarcoma II respect enroll and angiosarcoma and and rates tumor program, and paclitaxel response robust in response the high the continuing has study of strong ramucirumab. for also have with cutaneous safety Part gastric unresectable to to after commenced well, rapid oral profile in We cancer a I. observing With combination

from We in European to the received UK we week announce planning to were sarcoma. are that the to for other paclitaxel orphan the encequidar tissue pleased treatment and designation countries. We expand Commission the and soft last of study

are this In therapies. terms anti-PD-X, for working for opportunities indications, we develop paclitaxel and combinations for additional anti-VEGF to are with potential biologics, oral future of example, product, exploring

Phase paclitaxel pembrolizumab of Our oral is of or enrolling combination Keytruda in study well. X/X

in We cancer. of enecquidar with We presented advancing global phase gastric our results Phase the advanced the in study XXXX. ESMO encouraging expansion of study Conference with this recently are patients paclitaxel oral from also pembrolizumab at Xb and

keratosis, Phase other actinic X turbanibulin that. pre-soft ointment treating our for program, have to we Looking dated

completed pre-NDA the recently track is the which first have NDA and are consultation be in filed the to preparation submission, expected XXXX. a of USFDA with on with of the We quarter

continue safety rate, that effects side high for negatively profile competitive a Phase as clearance observed AK, existing confirms to limited patient over believe impact advantage and in by studies, trubanibulin’s therapies the We X are that clean which compliance.

about more that. treatment forward variable we So market, and option Jeff talk brining look the this to will

option to KXX-XXX in Now to developed early treatment continuing RND glioblastoma briefly to this unmet of are our have pipeline, the multiforme In limited that and Pharmaceutical, initiated formerly partner, presenting variable GBM become or for treat all execute as the made forward due to known of being for potential GBM, blood our very we the Treatments barrier. look to We patients further clinical its proud brain could clinical programs, are X across who turning we so announced is updates Xiangxue KXX-XXX, our a summary, high Phase progress future. ability programs. needs. we KX-XX. stage cross are unique to a study quarter, being oral KXX-XXX

Randoll? the to Financial With Sze. Randoll will I turn that, our call Chief Officer,

Randoll Sze

of ended Rudolf. XX, and to XXXX specialty primarily relation $X.X in compared months Product million you, to XX, September sales, and an fees million of licensing increase million to The license sales we the the XX%, with for million have resulting product specialty the that increase three of Cost of totaled three the ended from the sales million, months or for XXXX. agreement XXXX, XXXB was sales months revenue XX% were $X.X sale primarily ended million with $XX compared increase generally September and for XX, revenue The product primarily XXXX in into the million This attributable of XXXX increase for was increase three cost ended increase. September of was months year-over-year. to an three Almirall. of XX, in products. $XX.X increase three consulting Thank an in This revenues $XX.X entered the were and for sales of the million with cost as due September line ended XX, months $X.X respectively. September $X.X $XX.X

R&D XXXX. September XX, and XXXX months expenses establishment of to Research connection license was decrease months and ended for in $XX.X technology booked a three TCRT months million expenses XX, for purchase as non-cash September the three it development compared to million, the million September ended a with for the technology were the The fee XX, We in ended [indiscernible] fees July three related primarily in XXXX. in $XX.X decrease to $XX.X licensing we of therapeutics. in acquired was the of XXXX due

Selling, three This XX, three an totaled to fees. general due the drugs months XXXX increase and and was commercialize XXXX. for preparing to primarily for other million and $XX.X fees compared the $XX.X service administrative including legal proprietary XX, to cost September million ended ended expenses administrative and September as expenses, increase of in general our professional in months

million of million for the $X.XX in attributable was same loss ended share, $X.XX to per period XX, net $XX.X share diluted compared the loss XXXX $XX.X per Athenex or diluted months Net a to milestone this three or Almirall September revenue with on turbanibulin XXXX. $XX payment from fourth in partnership of We the the XXXX as last to be connection during and expect year. million in quarter quarter the received a recorded second payment

of As compared operating $XXX.X to plan, September cash XXXX. million company we XX, at cash cash, to XXXX. and enable into restricted Based cash equivalents equivalents, third September our the the cash, from XX, $XXX.X XXXX, expect us cash fund on of short-term of the our operations had be as current quarter investments million December and generated our with XXXX, activities operating together cash will to restricted XX,

operations only. full-year guidance to sales and year-over-year guidance our prior collaboration XX% XXXX. This we are guidance guidance in in is an of on year-over-year has of top of from Today, revenue our XXXX plant. raising product license of new increase our at and the increase sales to We This the guidance for excludes the to suspension provide guidance revenue $XX.X million and XX% XX% is made for product versus we August. into sales of Taihao API previous vasopressin taken discontinuation account this revenue XX% fees. the This

For to a line the be ended financial September changes well the specific including with please contributed those as XX nine results for items more statement the financials, XXXX, to to detailed Form discussion filed income our on refer that factors on our the as SEC. months in XX-Q

I turn now Jeff to Yordon. next will call to

Jeff Yordon

Thank you.

submissions of this and candidates, optimize paclitaxel. our As share have for our cancer. prepared as and two regulatory lead for expand product efficiently oral in plan clinical continued We be our prepare of launch teams market metastatic to capture for to to NDA choice anticipation the commercial product and chemotherapy to we infrastructure significant as develop market work as breast establishing of possible, the commercial

assembling our As to Cook, executives lead We’ve we Marketing, commercialization have his VP our plan team organizational Senior Tim and has finalized begun accomplished now highly of our staffing discussed, efforts. to make of to leading with up approval. including potential sales liaisons begin in months on hires board XXXX, leaders will in additional regional and early the key sales medical coming team full the science and

Distribution market will continued patient further with upon success approval. the breast understand experts metastatic dynamics drive to also discussion Access adherence have areas of cancer in the our and that our for We potential

promotion We patient happy refine market we of are see and have also strong unique target of can at oral to payer the paclitaxel to a and product candidate focused a profile positive conducting the segments, to physician response we our product launch. working specific so are research the

doctors who therapies with We’re supportive an target are are working on physicians right option and early terms patients new them. the of expecting treatment oral of hands in patients generally to to and adopters find for that their of

substantial Cancer the presence. As San Breast we will Antonio have will where highlighted us be event Symposium next key the a for

the to generate to then Antonio on second this Athenex paclitaxel our ASCO X earlier In to the interest the awareness will be addition Phase and an oral Oncology and opportunity San at introduced and continue results efforts presentation further in year brand. the

concrete KOLs commitment signals Our visibility designed and are with long-term to to provide oncology. around activities the ensure and strong presence of our meeting

new empowering patients which why Specifically, the that heart our empowered everything we it’s does. to of theme of at campaign launch is Athenex plan the and

a in you you booth. San NDA encourage preparing would our the visit affairs website. Antonio. program booth commercial ointment around with In including we have personnel add ASCO, full-page I efforts initiatives to staffed of booth oral with attendees and with Encequidar We forward look our a the paclitaxel some we are well as to to as our will seeing to medical submit parallel drive for tirbanibulin As our and U.S. and to in

As Johnson on lead is efforts well as as to approval for mentioned, remain will Upon U.S. Europe. the market. for we treatment Keratosis Actinic novel terribly file the Almirall the a is ointment tirbanibulin underserved which commercialization track NDA

As announced the plan and We tirbanibulin the and XXXX retains partners Australia, QX launches commercial right depending are with in and the early QX directly in Athenex access product significant global experience in our conditions markets. expected resources as United for or in U.S. regional for markets the Canada, by Europe on the respectively. such in to with Almirall XXXX in and Japan, market these several Asian own markets Israel collaboration States. tirbanibulin

commercial to addition we are stage late pleased revenue once growth report pipeline In our again to this strong business. for existing progress,

As to of products APD and launched XXXX. third new this total X new X goal for X of recently the driven with launching XX a in by launched currently product with our were we products, X by markets products our which the SKUs. new revenue In SKUs, quarter, markets APS beat of Randoll the remainder QX products mentioned Levothyroxine. was XX and with projections product led XX

As Athenex’s decided Vasopressin the regarding litigation discussed, not we in table. was

have in contributor a It result Vasopressin vasopressin. has was litigation it and proceedings a and the was certainly of revenue also been significant now disappointing to we a XXXX. XXXX. marketing driver discontinued growth was While this ceased unexpected, not

continue to add We relationships have opportunities will especially portfolio to we built order and seek the leverage recognition brand products drive in further pharmaceutical to and our to oncology. and growth XXXB in

with on front, the is which manufacturing of cGMP On continues York, our we the becoming of will eventually building with XXX,XXX New year. with anticipate next early products of Exterior operational the this and we and equipment Once continue injectable proprietary New in construction we or are plant commercial late expectation oncology our begin manufacturing products York interior our that the our complete on second Dunkirk funded way as well filling square-foot is work XXXX. construction online, plant will well. in year XXXB order it production the State to the half and

forward of to production bringing API The batches completing the in to of facility across that value our this look integration of global capacity announced We construction ensure this new expanding our xUS for and China, we capture API opening facility needs to in we API of ongoing commence Athenex’s construction our support XXX,XXX to square uninterrupted support foot, online. The first future clinical development part an supply XXXX. and the facility significantly expect our entire Chongqing, half strategy completed to in September, we launches. and commercial is facility vertical operations in producing validation be will of order supply chain.

of at may decided in in facilities second the you a manufacturing our occurred facility few recall suspend China unrelated at in incidents to XXXX, Chongqing, after As current the region. operations we quarter

to have clinical taken steps activities backup registration near late-stage products the able sources. additional we and requirements term we secure we ongoing for support studies believe Athenex’s for will However, and to be clinical

will an We in due course. provide update

integration. successfully preparedness, So to of continue with objectives execute strategic all to to our respect vertical our summarize, commercial we across

out and to oncology marketing our broad brand infrastructure. continuing global leverage opportunities, We’re establish build our

Based anticipated soon paclitaxel honing product our we the and positive We’re of hit encequidar. ground and feedback for actively first expect date, approved. as progress to the sales the advance on product in market the and strategy as made launch we’ve oral to the developing running is

the call Lau for Johnson his now wrap will turn I back to up.

Johnson Lau

in believe year Athenex, positioned leader the oncology. have to on we remain which we for transformational company a We you. Thank as track global mid-XXXX

year we As to be growth. coming we’re in towards of X XXXX advance months, another the NDA important to filings looking

in you. actively capacity We with to our stakeholders. as conduct we expanded sharing We terms of move your global take for would commercialization that forward value you preparing long-term for to to development clinical well exciting strategy. achievement now of substantial continue help building our happy our forward, the questions. opportunities our will as pipeline We’re execute us be trials growth look as Thank ahead to our

Operator

with Thank you. Your from question with Instructions] [Operator the of Ling line Wang your first proceed comes question. Please JPMorgan.

Ling Wang

the taking you questions for on congratulations my Thank and progress.

wondering to my updated us more full for you you with PFS presentation, can oral you to the there? you question San us secondly, data. need the to Oraxol potential will further clarity give why regions, maybe understand FDA the regard is there mentioned opportunities with on on any So – whether chances then and might look on comment be meeting especially think some you you whether the the might us maybe see to for have you. filing? partners first OS. are to the regard can or with Antonio I mentioned up lastly, to data help you other And can regulatory Thank more I August explore And for strategy you details in there filings was

Rudolf Kwan

here. It’s Rudolf

Let answer questions. your X me

regarding is submission engaging the one you we the on process are Oraxol. on with paclitaxel on the FDA quarter with are track oral our XXXX. tell first update with to I FDA on first and we for The can actively NDA And preparations

the present data We in would regarding III to definitely what the results a August. San announced III is from Antonio? Phase full question dataset line second see expect Phase trial you to in top Your intend

We we to to all a present etcetera. compelling standards subgroup as Some you. to details very data safety include believe of have examples as set physician the dataset demography full of community those would the analysis, like profile, well

this law, as looking have planning we to that you OS planning be the asset are into. on are data that or we time our before are we this at at reinforce and comment not have Antonio you for guidance will although PFS to, what new FDA when so or we we further ready from PFS, at data OS I’ll set previously cut-offs, defining are presentation an seek cannot alluding We San to – point. on look

Our a planning commercialization U.S. right? last from ensure outcome question regulatory that regarding perspective. are regulatory discussion We to is the active regarding and other The in the territories. objective and is best outside

Of course, E.U. important authorities China, is targeted are have discuss we regulatory one. all the Newzealand most to with. and Taiwan

Ling Wang

going in great. you your on those Okay, And do or you’re partners do look to regions, for to it plan own?

Johnson Lau

We are exploring to all the make our experience to a the have as sure to options opportunities. this the Certainly, of do for there of are experience we management in advantages be different partners. lot and maximum team we and having want that time will pros capture stakeholders. and in At do terms same able return on explore territories. these We region have our of based therefore, well that have vast opportunity we

Ling Wang

Okay, Thank that’s very you helpful. much.

Johnson Lau

you. Thank

Operator

question. Markets. Capital of with proceed RBC with question next line your the from MacKay Your Kennen Please comes

Kennen MacKay

Hi, thank the you question. taking for

scheduled? have Antonio after quick and see just like or manner Now ask I then doing this endorsement year a meeting approval really potential or Rudolf’s scheduling, options endpoints confirm ORR pathway. respond FDA Acthar for window the a further And taken that trial it on to I has PFS regulatory of the has as days secondary sufficient question specific in design X been of point second the FDA sounded understand further actually initial given announcement, you understand us unblinded a top-line so that data the if I the reached out the strategic we’re in and can has that primary X Phase being well. you because I initial wanted an maybe at forward. place dependent XX point far? rigorous us months regulatory might based was to on the or if a to not be interactions to dependent you’ve this feedback OS statistically but San for the at the regulatory and think a help positive can secondaries? one help to imagine I on OS, for what evaluating meeting, on PFS do moving to ways FDA endpoint been some this were day had strictly of these on Then FDA’s follow-up initial of data just

Rudolf Kwan

Thank on in regarding the And are are you, the track actively in engaging discussion Kennen. first and Oraxol we to file we indicated, FDA as submission quarter. we communications,

leave at I point. to that also FDA don’t normally will think it I I that the will point communicate we you fact communications.

answer data feedback tirbanibulin was just the As again record do you regarding of endpoint primary not announce endpoints that submission achieving pride noticed are on the they question? our FDA response your based did the and dialog PFS consultation The the our program will consideration. the and on That with one we do that. Does shall FDA Antonio have not on that. for they we The the endpoint. it the and it or submission for we consultation our requirement secondary complete target. pre-NDA We’ll process previous put we announce are and the of may To receive this take OS our regarding in is a file San rate. the definitely – again, not will FDA depend from

Kennen MacKay

ownership bringing Yes. Very lot where options non-dilutive here in Thank on retain Maybe a about. maybe the these markets. with be a KXoX? geographies us questions, helpful be capital, maybe potential Thank should Rudolf. taking for very Can of option here approaching. if could regulatory this options follow-up most bringing think of San other then potential there just If you prevalent looking capital I again could you just was you the or any been if you for a of maybe AK the forward for licensing to have you non-dilutive remind potential are thinking some one on for in one going that. several Oceana of that there and and submissions much out largest option be – Antonio. we for strategic a were is

Randoll Sze

compound global actually tirbanibulin so by discovered the Athenex was KXOX we and The right. own developed

partnership to excluding with the rights with Europe, acquired Amro, the license they rights – and Mexico Russia. not to to Our also U.S. and have Canada

the we territories from X So apart these other own areas. global all

Now your there creating non obviously would what say to all like for with would in is we compound, beneficial that and I question diluted to that geographic with our capital of regard opportunities are stakeholders. this explore are opportunities like and whether terms for regions value other to other

opportunities capture front Certainly can for in to contemplate. will results certainly be and X we Now, this successful job are thank There we are the Phase be that and of Allow inappropriate assets ensure – therefore, you it your and yet are us discussions to opportunities to and us number lying details. is X we a question. of our for these have you evaluating provide value. ongoing quite

Operator

line your question. Your next of DeGeeter Oppenheimer. the Kevin question with from comes proceed with Please

Kevin DeGeeter

taking Thanks two Maybe questions. for for me. my

for oral to off, outstanding in quarter completed that XXXX First be on paclitaxel, portion submission? file steps you any the need NDA the specifically that to CMC for can of will of just comment preparations submission first the

Rudolf Kwan

to CMC your submission of the we question, sections. are first the actively regard With preparing for

substantial that contemplating to with product we indicated market a be that are a very As important to you potential.

is also C both all logistics the product top are the API Plan supplier manufacturing, resolving we that the B So the we into ourselves. primary Plan have in then and and of on looking vis-a-vis,

a that interruptions are ensure I Yordon – question. first to Jeff are and answered and hope success. and process there this myself are engaging interruptions. Mr. product, to your alternative when up be that smooth activities this ongoing be there no launch picked actively able will are All are our yet to that ensure will have also all to smooth to be these suppliers We no we

Kevin DeGeeter

made profile pertains that remarks Sure. outreach. regard in elaborate outreach of Jeff comments And with resonated to I initial in aspects can the more payer oral of to actually of initial question that second my terms believe the in product strongly some and paclitaxel more bit Perhaps prepared his with you a research. payers

Jeff Yordon

to look X encouraged be forms This about was pricing that acceptable. our The do feedback had different were very would that. in that to we’ve that be happy targets we held we’ve

original positive. We to similar and have pricing has ABRAXANE very pricing been the the feedback

on that the based like our on So very in we look forecast shape. we’re good price we’re selling based and encouraged

Kevin DeGeeter

helpful. the you. queue. in back very that’s Great, Thank I’ll get

Jeff Yordon

you. Thank

Operator

from question. the your proceed [Operator Instructions] & Your Please question with of Chad Messer comes line with Company. next Needham

Chad Messer

run. me Great, sense very start, my other the of let Antonio. progress for getting I kind regulatory got question. also is for certainly your Oraxol studies and into And thanks interesting indications? congratulations all strategy to I’m of what You’ve forward, San the add Rudolf on some taking my for just additional one for looking Maybe excited

or also there that than of rather of if basically calling is label you or piecemeal do to some paclitaxel Oraxol each individual used Wondering you expansions? anywhere have X. think might provide And those support this could level could any is it’s be in you indication Phase You’re you better X a used? do evidence think and

Rudolf Kwan

you, Chad. Thank

XX in right. sub-types based molecule Oraxol a has Precortaxol widely on are multiple and and multiple of quite studied known type intensively You used is is scenarios. which been

the in X,XXX, well paclitaxel, and So like you on number it’s at probably over X,XXX. publications sense if X,XXX, the look IV of the – possibility it’s

lower I have have you data from the with So showing as taxine monotherapy in – clearly the we we of than presence think that, neuropathy see dataset. the paclitaxel and the IV comparison, that to as the efficacy. with choose seeing Antonio And always when a and paclitaxel, San so I will differentiate of IV full certainly the strong rather collate no one is the with better our far in comparison you of to from a strategy a terms else that be think I repeating leverage compelling

will indications. So other a we very, that data of to very into leverage this expand piece is compelling

very, we especially obvious been progress in rare And the disease. is image very very of this to first in of that you paclitaxel, the reporting efficacy primary data. in of And because enrollment investigators saying and the rapid the difficult principal in possession one have treat enhance a the the cancer cutaneous angiosarcoma. Orexo, is of types like investigators, angiosarcoma, The where are to

So I’ll that. leave at

expect excitement for should to some early that seen see You’ve indication. data, continuing

approval got soft We which excited is everyone that. and also for sarcoma, tissue drug angiosarcoma the EU orphan about for therefore includes indication

tuned. stay So

data coming the of in You will see future. some those

those have to, data indications we announced the be of products, have already immunotherapy other will alluded and combination anti-VEGF mature. of and more In terms as we become

and leverage are better been than paclitaxel. other will expanding further, original has into and for So indication we IV whatever certainly used build all paclitaxel we the

mature. angiosarcoma we of they on other building also breast cancer regulatory other are and gain, we’ll then continue as and metastatic as indications terms In and focusing become the in and U.S. do leveraging indications to areas, other

Chad Messer

thank market of you this And Jeff: consumers, about ads proactive to talked sort the preparation larger maybe launch targeting early Does patients for or that that? a one sort you’re how internet Great, the be doctors? information to you little do and maybe you be about of sort physicians initially for Can or of early some that. then going for you’ve go patients. segment you’ll about doing of trying adopter centers get in the hands-on getting we’re talk some of bit the research excellence types adopter of that of to targeting think you and mean more out and in

Jeff Yordon

physicians we’re is and as to we progress type know be trickle Chad. so make those after at way getting others. responsive us this going therapy, down and have interesting: sophisticated profiles to gives we to the are things of look that with we to will really data Sure, will provisions, the it that most best of physicians, now access it incredible these It’s that

And that set. set the first So to we eventually then and programs a physicians move marketing then a targeted and already we positions, our we’ve specific and will very second to third group be of have those identified.

that hope your question. So I answers

Chad Messer

Yes, congrats guys. thanks and again,

Jeff Yordon

you. Thank

Operator

Laidlaw Jen from question. proceed question next of Your with comes with I-Eh & line your Please Company. the

I-Eh Jen

Good for the questions. morning and thanks taking

has I Taxol, weekly the that The see that? side asked regimens, in with you of investor Taxol first is particularly some say to benefit question IV the Taxol, of any safety have do whether you oral compare the if oral let’s the

Rudolf Kwan

if bigger is But since infusion: those paclitaxel, will Yes. dose carefully, have X IV limiting everywhere is significantly Grade safety, about for at weekly in all they come you center. talking X, have in the blood, neuropathy, the benefit that dosing is to benefit about don’t major in look you literature, definitely that then already the literature at Clearly the limiting we trip And especially announced to Grade paclitaxel neuropathy. we that infusion. asking and IV the you’re regimen are you all see toxicity for you neuropathy look see weekly the infusion

IV that differentiate to from a So in significant have major – weekly ourselves we I think paclitaxel. advantage

to San Antonio. do come So

whole You’ll see the dataset.

I-Eh Jen

Okay, one which too a be the That’s research. helpful. very is Maybe have great. it you bit follow-up here, about early, payer might but that little mentioned

provide color of additional any might sort guys consolidation the there is of early at sort you So of stage this process?

Jeff Yordon

was things. very that’s and product, Taxol about looking of pay, most widely be advantages pricing would willing A the by to pricing couple and and good original the to get generic pricing because much the going the be advantages, to the inherited Yes. equivalent Abraxane to we’re one this be that plan Abraxane yes, at that payers. seems One, be of idea the costs argument encouraged of to payers, our accepted say very to a also

but data. we’re by encouraged early, So that very it’s

I-Eh Jen

OS that you helpful. And time Okay, terms the progression-free for overall times. FDA difficult both agency great. guidance meeting in this the or that to very any as at tackling from the the well the just moment? you seeking cutoff just prior mentioned think to maybe Antonio are That’s questions, as feedback of whether I’m get survival you curious that’s tell you again San might

Rudolf Kwan

Yes.

put cannot we endpoint upside the analysis, surprise a The since to when get perspective. our now as it strategy the pleasant that it very the it’s we question want is we in final implement the said, pre-specified to that not What I at we and from that for So will leave specific are before have to I the question. seeing to clarified would because it about trend. that – FDA answer important the analysis would be want secondary clarity will into acceptable specific it’s FDA that. more As put plan? secondary actually strong be dictate regulatory labeling endpoint protocol, in we a will

I-Eh Jen

to And congrats. very very, Again, helpful. updates. data That’s great. I the look forward next Okay,

Randoll Sze

of I just want update in your to give question. second you terms an

both proposition obviously proposing payers. the to the will be study product all You that providing we patients we’re value in our value conducting we can And much patients as to well as terms that the are anticipate pharmacokinetic this, obviously the to of with as the will well that regard very both of payers. I support economic as the

marketing how to think vast your have that in with approval these support we’re clinical are And as launching to want launching I have So are certainly, post approach development, important you all mind may to regard products team of terms within we in in product. well going considerations our both our sales. and as experience

this successfully. highly think with well I that we launch fact regard says you Thank prepared to to you. that to product the are

I-Eh Jen

very And that. again Appreciate that’s great. Okay, helpful.

Randoll Sze

you. Thank

Operator

the call gentlemen, and question-and-answer back of I remarks. the session, end Ladies to reached and Lau, for have turn like would closing to we the Dr. CEO, Johnson

Johnson Lau

for everyone, this you, morning. your Thank time

towards significant to catalysts. advance major continuing made have We progress and

encourage as you Symposium. like afternoon on Encequidar we the interested San booth. us quite upcoming join a those will in big, our Antonio in The presentation will Breast we have in oral and inviting you and data, For presence, as to XX, strongly be Cancer paclitaxel to our December join good a well to

to those attend your to this meeting, Thank for you work prepare also to therefore, be we product. that preparation For the again able regard with will the very who that important after meeting, launch of time. we you will and are will to able is not update the the be all ensure progress provide update and you

Operator

conference. concludes This today’s

lines your your participation. for disconnect time. this may Thank at you You

Athenex (ATNXQ) 10 Nov 192019 Q3 Earnings call transcript