ATNX - Earnings call transcript Q4 2018

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Operator

Greetings, and welcome to Athenex Incorporated Fourth Quarter Fiscal 2018 Earnings Call. At this time, all participants are in listen only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Tim McCarthy, with LifeSci Advisors. you. Thank

begin. may You

Tim McCarthy

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

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

You in Investor can the Officer; Sze, Chief Kwan, over to other Johnson Financial Chief or This Rudolf to I'll the Relations call and the that, at Chief section website turn Johnson Randoll by find the Lau, Medical who morning, Operating sec.gov at prepared athenex.com. Officer; Dr. Yordon, our our Executive for and after Dr. in comments. are several will questions EDGAR Officer joined at Chief databases Jeff SEC executives we answer Officer; available be remarks. filings With introductory

Yiu-Nam Lau

everyone. And morning, Tim. good you, Thank

very early be is exciting for We already Athenex. in are shaping another this but to still year XXXX, up

of transformation further the company for creation. potential and have value We

Src both Phase important have and announcements from programs. Orascovery III Kinase We our clinical

of Athenex Oraxol and believe advancing outcome should line and very Phase Beginning announcement for January, XXXX III for that in Orascovery top Besides continues for planned a of us trial announced treatment in are and our for testing enrollment will breast results the early and most in will We major the the breast promising that cancer. we Our patients ongoing to metastatic from a our available We technology. successful XXX path and data important technology likely most first a commercialize midyear. the the in generate set be reached milestone is product. results potentially be pipeline with Orascovery, target validates our to Oraxol of on other therapy will combination cancer, serve validation with targeted we as immunotherapy. that indications our

our evidence we in Orascovery far chemotherapy have technology We delivering provide various orally. data is works capable so are progress making programs. The of also agents generated other additional important that our and

candidates the believe technology we will absorption more with in drug effectiveness to and a Oraxol, advance Importantly, paired able the oral that other be of development technology with this and efficient we'll expedited safety it demonstrate our process.

We Oncology thesis number have Orascovery this the the that probably program had Athenex and American And of of meeting. will date. on ASCO ASCO, abstracts be [ph] in fact, programs pipeline Clinical one Society submitted to through our a other

six on this of data presenting our be at will We products meeting.

in keratosis. occurred differentiate XXX in top positive it this tolerated in studies a this presentation the XX%. X was D.C. KXX-XXX Phase line is of activity The presentation be that XXXX with results actinic excellent safety to Phase of for keratosis March, These believe Academy our treatments. of over just studies oral rate results year, shown on profile at significance, and III face the III approved, in XXX statistical to Meeting product from of met The clinical beginning excellent their is once both were week the was late-breaking which well demonstrating Ointment existing The primary Dermatology announcement We the Annual American at or as of of Washington, a treatment second from ago over of treatment actinic endpoints will scalp. compliance serve featured this

the provide medical Dr. what suffice results. believe But has Our with of clinic. in Kwan, product the very to demonstrated efficacy to details safety officer, say, this Rudolf we will competitive be you a profile and

that We The They increased leads with they with the KXX-XXX in dermatology commercializing U.S. mention to this are one briefly development assets partner. Europe, this footprint is their in and U.S. Athenex in AK Jingdong payments U.S. by the partnership dermatology collaboration (sic) Allergan and be that in I dollars a very the China. signed addition We of product to to think in license companies of are millions royalties. to Almirall in are milestone and agreement in potentially Chongqing strategic of the Pharmaceutical with commercialize sales are that the was have could want Almirall. independent ideal recently XXXX and [XXXX] December They market. that economics acquiring favorable commercial hundreds of the in the leader the

market You'll regained reported to of and decided The significantly right oncology probably this in year excellent we XXX revenue $XX.X $XX actinic dermatology in was from and commercialize XXXX. have keratosis last XXXX are week have the proceed additional in up the position million, collaboration million better our planning us in we China. that that to XXX seen the for have with profile to we will and announcement opportunity indications China. the capture not mainland Full

of was shortfall most was an recent the Pharmaceutical due $XX.X guidance, Although from of receiving the licensing fee us to year. the Jingdong expected our not Chongqing million this below at end

to continue business operating our well. perform Importantly,

XX% up sales product have year-over-year. We

Our well an Officer, XXXX. you call our our to will now for will over as financials I on Dr. Chief clinical CFO, turn guidance pipeline. Sze, as to Kwan, our Medical updated the update provide expand on Rudolf? provide Rudolf Mr. Randoll with

Rudolf Kwan

Johnson. you, Thank

the American D.C. Dermatology on III breakout X. conference development Now for begin keratosis. of pivotal activities. late in in data clinical at X KXX-XXX our for Washington, studies actinic positive the March review We with We Association our program of our session presented from Phase Academy

clearance field previously results study results These XX% of showed The the achieved based Ointment time safety a the statistical by significant And was were we XXX% respectively presented We which data, in of appears Safety patient existing there their XX% patients of studies show of was the vehicle. was to XX% and results both again, the various for of endpoints, AAD particularly in may first And have and with AK side XXX have patients XXX. clean rate that KXX-XXX key announced with each clearance AK each it become Also treatment. associated effects. drug, than high favor note higher who This successfully the day of was Of is are a completing it for the believe very KXX-XXX tolerated, in both versus were II. over advantage presented given trial, and at that that profile. XXX% for very study that patients, troublesome XX. primary this met compliance was the in reported percentage subgroup, XX% clearance Phase competitive on we lesions treatment data the very rate subgroups. for important. well

highly discuss to about. the involved Last call with major investigator been joined and II Dr. the that were dermatologists dermatology by to expert program, contributor this on Dr. they as Monday, our we Phase data regarded and something indicate discussion a III AK call hosted Forman, and is Our care Phase having this an a conference Seth studies. in

AK, KXX-XXX responses. had Forman data, and gave an the to still had overview based who clinical change clinical approved. and complete if for III to of ongoing treatment his in the Phase X AK on year of landscape practice the studies the complete treatment the opinion, the Both of follow-up current stated and that patients are potential

be to or the data submission meeting drug pre-new time a regulatory to submitting line. will discuss request We for and FDA submission the NDA, application

discovery oral in Next, is metastatic we candidate, III breast ongoing our leading Oraxol, an turn currently platform, for where to trial Phase cancer. our

on Johnson in study target and board safety endpoint compare recommended as the is continued. case, the a the already of criteria. is completed independent has study Safety Data in designed assessed The and primary RECIST superiority Oraxol confirmed in response As each passed X unanimously over XXX that Monitoring we the stated, where, patients reviews, based January. rate enrollment trial paclitaxel, to by IV of demonstrate and the It Board successfully

available We expect be that will results midyear. the this from study top line

we This As observed. We we we XX publications, metastatic Phase another patients program. the disease. clinical major Drug With presentation dose-limiting partial stable submit in Oraxol a to year limit may the efficacy the of trial. Oraxol October, were results Oraxol the encouraging neuropathies safety review primary for XX no of of and Phase Orphan hope last in of and patients III presented provides patients from Phase medical commenced achieved our There II clinical XX status that granted from reported, angiosarcoma obtained had further have at cancer In treatment breast I for confidence peer were and time. announcement meeting endpoint at patients trial. remission data Designation data the for and clinical

the Research May. angiosarcoma has meeting Oraxol at preclinical accepted summarizing or been the abstract Our data AACR for for in Association in Cancer American forthcoming post-therapy session

In are cancer in patients Phase solid In Oraxol pembrolizumab Moving to studies year, we second last Phase December cohort. anti-PD-X the and VEGF-RX onto and of the Ib our tolerability we November, dosing cohort our development our collaboration for assess ramucirumab, patients, regimen the who Phase identified in Oraxol. studies completed Mayo II progressing half I/II with the of to plus with studies combination Oratecan and a clinical in these first we of initiated XXXX. of chemotherapies previous clinical Clinic. initiate plan and gastric well with Oradoxel patients, combination monoclonal In with programs, Oraxol the third advanced in in have our activity to safety, global malignancies antibody failed antibody trial with

Oratecan, we we X exposure for docetaxel believe identify every will produce formulation as And a to Phase of X we IV can weeks. can similar of believe dosing with that exposure achieve Oradoxel, similar For II is that docetaxel, days dose we which oral the or irinotecan. IV X that

cancer a programs planned. In a Our continuing will believe drugs establish platform potent other to in for other we which I several paradigm programs summary, potential our in new as and Not including response treatments. cells. selective we use to to Orascovery oral are the development, the anticancer of Orascovery overlooked, provide have TCR-T stage our direct program, be cancer has Phase early

a that as We're this successfully an arginine, with also IND cancer IND pleased the acid superbly oncology an half our on of for has We report is pipeline may We for depleting our survival. to mid regulatory healthcare submission and for planned year, by U.S. to tumors enzyme partner include growth of amino TCR-T resource Therefore, our the Pegtomarginase the middle of China an XX for this IND Pegtomarginase before file setting first early our are our year. in to in of submitted programs key long-term authorities, stage of company-sponsored China the their program XXXX. strategy. track see very the part clinical expand important capable the we candidates. potentially cell the

mentioned, Operating consideration we call Chief ASCO for turn Johnson in abstracts Jeff? stage the presentation of our in the of submitted all early for to have now As early a to I'll platforms, Mr. Orascovery, Yordon. meeting including cover over number not abstracts only Jeff our June. annual our Officer, These programs. forthcoming

Jeffrey Yordon

Thank you, Rudolf.

And and a give our we the side maximize established of in progress building fully building help plan of and global believe great value. terms clinical our that we at programs, ultimately creating the the commercial will company. groundwork supply chain a have continue us is us advantage Athenex integrated today on a pharmaceutical competitive Given capabilities to

these Our in order proprietary And enormous capitalize they large product will critical and products really address are well opportunities, elements approvals manufacturing they is potential. if advance are the commercial to But commercial that in place, on we it successful in launches. clinic, believe of markets. have the in and

Tim XXXX. well Eli Cook, and the us President Our Operating of formerly who us Senior Oncology Lilly, of Officer Mr. advanced under leadership Tim President joined for as Vice marketing now Oraxol joined Global plan was from where of he oncology. Chief is in Vice

in As with developing work instrumental this the been the with operations specifically on plan, of and healthcare community, prescribers. APD we our gatekeepers, relationships influencers various subsidiary have

and conducting are and is closely and Almirall initiatives groups. and are KXX-XXX, work are commercial groups with marketing we the advocacy for leading them. Our supporting already aligned clinical payers

Almirall will regulatory the early of the sharing data We likely we charge in in and filing are seeking forward will in in approval be We be a other U.S., territories. EU of the in to with clinical the timing the pre-NDA NDA submission FDA believe and XXXX. look the for meeting. that the responsible

work construction biopharma drug the use This the intend front, in we manufacturing On the New Dunkirk, for is production on is to plant square now complete. York XXX,XXX foot facility substantially our cGMP-compliant manufacturing. exterior

be is in will We by there. validation products The place. next installed will completion work an progress, this will FDA the stage take will of process eventually be including interior interior. the and And the proprietary manufacturing be inspection while equipment

funded to As lab a of and the well as reminder, up headquarters, is a of State corporate agreed State New as state-of-the-art public-private aggregate fund our million. plant with strategic our through $XXX cost York. facility to being of has this Empire for construction the partnership Development all equipment an the including

support our for approval. our sufficient products Chongqing from markets progress also XX SKUs. made trials clinical with have with XX China, products eventual similar support markets to X product will with launches, be critical API assuming and has currently which APD in financial capacity APS regulatory This government. SKUs. ensuring XX the facility We received

the in shortage during our oncology is that an platform highest were a product expect This products United unit strong is the XXXX. providers. with XXXX. in product X-month principal is We probably commercial of a our important us This Ondansetron oncology we example a very most very and will XXXX. the additional relationships States, helping supplier in was XX in product build good that launch

to the on XXXB used hospital. of end a the at include is acute list. FDA been of API Levothyroxine, situations complaint we Services that indicated through which in the that bench, not Human learned in continue also FDA requesting XXXX. QX response intend FDA. expect And the till to We API it then. XXXX turn sell significant list major Vasopressin critical to The court is Other including the include of the and which antibiotic until a it not we list, from was Vancomycin, list. decides March We FDA adjoined government the won't now Bulk decides the for any more On believe which deciding to contributor Athenex's and action to we if the highly product court the the compounded in the in sodium March Vasopressin that not Vasopressin product, take the I year the one if on X FDA XXXB to will wrong against products financials most Vasopressin have X, agreed was Department the over the in will the the and continue not which court's a the In unlikely. XXXB the key depth. Randoll which court a throughout be will on The is to we to shortage unless of API hearing the against we least the shortage Mr. Sze indefinitely. Vasopressin wrong from call have has filed our in and include bicarbonate, Bulk We officials discuss rules May, for is expected have to we to significant supply Vasopressin a continue expect list. judge was on June, decision, on certain in FDA's hold FDA on be the and late April or including Health decision to Bulk selling suppliers

Randoll Sze

million There licensing our and in through QX $X.X will fourth $XX.X compared a $X XXXX, of I and Revenue in Product QX million was of $XX.X quarter $XX.X Jeff. for pursuant now QX XXXX, primarily product entering go docetaxel million we're in in in December to $XX.X you, in arrangement million as sales for change to oral XXXX with XXXX of first. QX was million QX XXXX $XX an Thank respectively. XXXX for were $XX.X million from to territories. million. PharmaEssentia to increased result XXXX, revenue our increase financials fee Asian certain in sales rights Cost mix. a as a licensing XXXX QX QX to million

to R&D over expenses QX our portfolio, million. gross As product XXXX margin we continue might totaled our fluctuate time. develop $XX.X for

the R&D R&D clinical million in Net in than majority same million period same for Our QX year. $XX.X The for XXXX. a compared QX million the per period was the line XXXX XXXX million for XXXX in attributable loss the or QX to $XX.X our period same loss per totaled $XX.X in for million, $XX.X XXXX. diluted share reported diluted net was expenses a in $XX.X programs share last $X.XX Athenex expenses for the lower slightly of expenses. $X.XX to with various SG&A of accounted or

There in for go full in XXXX to major XXXX. in is XXXX. going $XX to I'm through the a million increase few a million items P&L from year significant $XX.X revenue Next,

As upfront from Athenex net in compared payment attributable for $X.XX million in increase of million $XXX.X Almirall, loss $XXX.X Net which for $XX.X diluted $XX of significantly mentioned XXXX. the we per to The XXXX per earlier, KXX-XXX to product full year to a sales also XXXX. a $X.XX million in was was out or the licensing diluted loss increased $XX.X in million or million to to XXXX. shares share XXXX received attributable

our fund the short-term million current aggregating enable of with on the together XXXX. equivalents fourth XX, at operations from operating generated least December is we XXXX of XXXX, attributable our million with Athenex diluted the XXXX. to net of non-cash and of investments quarter cash, Therapeutics, us licensing the we TCR-T investments XXXX, expect our at activities fee cash share. which At $X.XX per cash operating and the connection was $XXX.X be to through of $XX at in to Excluding for entity million plan, million had end the $XX.X equivalents to loss $XX.X Based establishment short-term end cash July the in Axis year or will compared cash,

detailed more those a filed in the financials, factors on statement, discussion with contributed SEC refer income Form to that to XX-K that the on morning. items changes For our was including specific this line our please earlier

our Now guidance. turning to

forward, exclude and the on will revenue will license Going estimates sales company's for product and guidance only collaborative fees. be

have provide on Product More our value and and our remain importantly, regular updates will be drivers we guidance. core to clinical progress sales which of company. the results activities, business exceeded

revenue. fee full from earlier million discussions inclusive $XX.X of previously close to ago. an In guidance quarters Pharmaceutical. started call, be accounted and payment for our for mentioned this million, licensing licensing to Chongqing revenue XXXX Jingdong provided was had on we As the fee X we year upfront $XXX revenue had guidance, of These

However, as Chongqing turn announced reported Pharmaceutical by final XX% Johnson for that, from anticipate With XX% terminated year-over-year in mutual million revenue. there to I'll some of our last week, sales Jingdong with we Johnson? agreement In the XXXX back XXXX, a consent, product will be XXXX. was it $XX.X comments. to for increase leading to

Yiu-Nam Lau

Thank you.

to a patients company is cancer tolerable Athenex biopharmaceutical global treatments effective, will mission market. by bringing Our to improve at build the of more lives and that safer

As create consider. we that X to think about our need strategy components to way we the are value, and our best important business of build there

our is on focus exclusive first The oncology.

The R&D second is the to and synergy our we are in both operations. create able efforts

that third team the we is The component assembled. have

an building our commercialization addition our global are we scientists, collaborative leverages approved products. infrastructure order both relationships In who facilities achieve to distribution in team, experienced global and to that of any are product hiring

it development believe be best for our which cancer this components open a with which becoming We're and Thank I'll remains If to on that, see also Combination immunotherapy. building opportunity. will metronomic excellent making we understand Q&A. market we now at for same our how chain. serve time, And opportunity infrastructure, largely creating through products we're standard And a shareholders. our our us to the dosing entire the the conclude trends. can is successful efforts, to to is or different of floor oncology great we about and on presentation the With the commercial for exploring and clinical the manufacturing the untapped are value therapy, treatment. strategy, therapy combine important the you. finally, progress and value thinking community capture allow We maintenance

Operator

first question Our Instructions] Kennen MacKay with RBC Markets. Capital proceed. from [Operator is you Thank Please

Kennen MacKay

just pretty questions from pre-NDA filed first, on scheduled could KXX-XXX, Thank just I us on housekeeping you a you was in the wondering was Endo, you a planning was growth Vasopressin housekeeping ENDP, couple quarter. some if taking for questions. to much solid the here. is for was QX? numbers or And I Maybe, for had came Jeff. congrats understand said wondering then put had that question, be how help and or sales? again, the that that of And out something a

think color number that, relates revenue could saw lastly, just especially Randoll. hadn't of wondering us not because like heavily QX relationship sort just a that there? to a excluding impact, that litigation we as but there's seen you of be that help milestone plan, it for this if Thank recognized, understand So question from - if according a us ongoing Almirall. getting go that's as everything not with about if and would you're I if in what terrific? understand does certainly to any you. instance, with could given I or milestones but currently and what fees, And the major because the was wondering could housekeeping marketing help we then you for

Yiu-Nam Lau

completed, question of we XX submit the The follow-up month we that -- answer the then for complete the follow-up quarter, towards will regarding and me let once responders, meeting Kennen, are the that KXX-XXX request. question. targeted the pre-NDA is is pre-NDA and second the completing

quarter following completion So request around second be the end time the quarter. follow-up third the some will the or XX-month the pre-NDA the submitted of of

Jeffrey Yordon

for a product. Vasopressin, our Kennen, the of me XX to X to previous explain that you hospital takes product first it from let all, convert weeks to to about

marketing that you hospitals The easily it's that year. switch XX% of this of we the million, will for make surpass want that sure in before the the be commitment about first they to list. we $X.X of We couple about anticipate should the months 'XX have product, to was revenue on the been to that and going make and stay aware

Randoll Sze

Kennen. Hi,

maybe milestone the On payment, background. just bit give me you let a more

the advanced since December major various KXX-XXX program XXXX, including have And very markets received of So positive exploring course the opportunities. lot we deal in year. over different been and a this of given China obviously, of in we've interest stage last signing Almirall

experience the sector they looking sizable payment potential announced the transaction, payment, Pharmaceutical, next milestone sales a Almirall with terms their would as to out coming is then, them in, pharmaceutical be about strong $XX - you But of The back to like thing one to quarter in million in be -- a that's for milestone to this very the a events this in either force. to there go as milestone un-seeable end. potential close week, coming and Jingdong that's that million we result demonstrated this on we in going agreement And earlier to $XX is March, Street talk or quarter. considered And as good why, So last very partnership. unfortunately, partner we mutually terminated the of

our, say, payments will near I to licensing with that the milestone the So term arrangement. be would regard guidance on

Kennen MacKay

for help. just into months? analysis rates what going you Is Rudolf, least clarify sold Like towards the questions understand it then manufacturing And at that? relating the Oraxol that at is of value then response of a is what you trial? the could trial then that the of the I question program, a wondering final was Johnson. much the primary on be capacity resist the that landmark you. towards confirmed essentially that or X through - if the of confirmed a feeding paclitaxel best or also that wondering, months paclitaxel rate is X percentage sort to response Oraxol. response And sort just endpoint. - Oraxol if of Thank maybe for maybe was very much for And help there you maybe for product business of were whether is API Got if couple how on I going And could current us clinical – of overall would commercially? the I maybe manufacturing

enticing - of the concluded that of hinting dosing. question. seen maybe there we be of you'd be seen a see elaborate much Can maintenance had so sort metronomic indications could first Thanks for that what indications, given You sort some from sort could the evaluating the on maybe maintenance that be call, you taking there the could perspective? efficacy from

Rudolf Kwan

is let on months. least answer Indeed, overall it me rate the confirmed a X response Oraxol. Kennen, question at

So be study the to week that first occur best week first is one, so at confirmed response week of the occurred response. XX, confirmed And XX. be such week look it XX, we design has at the response be rate. weeks - will for week XX in If or if XX at can it it's the it confirmed to but XX overall XX, - not response

Jeffrey Yordon

Kennen, this is Jeff.

would million, obviously value our have capacity used revenue. for I In $X about which that been clinical terms of X/X at is your question on about studies. of being API paclitaxel, would

when significantly revenue to new we'll coming contribute the completely much be and onboard will the facility give it able more capacity, us it's and on With onboard, more line.

Yiu-Nam Lau

have and a the answer just have - of To you we're keratosis. very additional able first excited other we believe of oncology for XXX and and indications, program questions. to dosing. actinic not another other of it relatively will easily, part that, the the you us that for be So we - in X to for that skin been extend is that dermatological and X with capture, part question, given for your indications of to for KXX-XXX metronomic against studies advancement and preclinical the of see on we that believe that. indications doing KXX-XXX, we One is question your studies, oncology oncology And also for potential potential based of the third activity that we the it sort potential I have other have will as our lot obviously, believe has opportunity the the process Oraxol,

number of are For investment regard we metronomic patients for XX to a our our the dosing, program that fair patients lot well beyond question community with and beyond share Phase a your obviously, therapy well III with part weeks some a receiving of other the with - year.

So metronomic Chief Officer, of dosing. would therefore, translate in for information patients the of Kwan, I answered drug good Medical pushing potential opportunity forward. And maintenance are Dr. our will certainly, And important very clinical help currently be is or proving therapy the point. obviously, indicator this terms the evaluating into the and can best follow-up options piece all that your us already questions. on the hope, a of I that actively

Kennen MacKay

very on did. you congrats progress. Sure the you and much Thank Yeah.

Yiu-Nam Lau

you. Thank

Operator

Our next Messer & question Please Chad Needham with Company. is proceed. from

Chad Messer

second And Great, wanted KXX-XXX just start for safety follow-up waiting Could we expect believe the on quarter a Obviously, then and they all you that to and taking if lines time - meeting. the we're I good I questions. request then forward. going complete morning. and have that confirm meeting thanks filing accurate? pre-NDA XXXX. my in you you're going for in data said to early just Is

Yiu-Nam Lau

That's Yes. what plan. is the

Chad Messer

can are that of remind All U.S.? in And right. this product? Great. you expand And Almirall's Thank of any the you for plans us just presence commercial aware you. then, to

Yiu-Nam Lau

Yes. Johnson here.

Let me answer your question.

top called will brand their for forward. and product one as in you product, to they aggressive our when driver and that very in thing to value that's actually A-Q-U-A, future the share mean, back been is as the so is with aware has Aqua, plan. try of the The their Almirall I which the that the we investment And this product positioning is U.S. of that other they key U.S. re-brand community the creation Almirall Almirall's Aqua going launch Our U.S. X should be

here feel release, the their you all is that presented be important we the full as they And their their that look indicated Almirall we the the then product capture this the company compound if an the that U.S. was in they indicated successful future for product million. can them, with position that of portfolio sure they by conference KXX-XXX think surprised then Almirall to press our information franchise they that felt for in the in happily this with very U.S. were release them important pipeline acquiring And that is sales in when making right in KXX-XXX they U.S. call the a even Allergan that indicated - can advancing the committed release. ensure $XXX acquiring to were of dermatology future in that they asset that Allergan their And become in opportunity from piece that both will EU as - will that, component terms also - or move other that well The is the for press was the into the press team I very the the when fully actually in and important of as share

Chad Messer

item. Thank explanation All for is of a higher there right. there just that. then was Great. help for an for a sales looking XQ. Is P&L on Cost -- some a you little And in that? lot

Yiu-Nam Lau

Cost sales. of

Randoll Sze

Yes. Yes.

fluctuate. might I the time, call, As developing the of earlier product that's margin process time our from platform, to mentioned the we're for portfolio the on why obviously, commercial and in still

the actually you I of we high-margin had earlier, If capitalized remember, on last products. mean, shortage some very year,

we opportunities products forward. will on continue shortage So going and capitalize to explore high-margin these to

Jeffrey Yordon

Yes.

XX have also from had for X actual some Let And we payments ago, the backloaded about of -- in -- Amphastar. backloaded were licensing products XXXX. That upfront was and that payments years me we payments. purchased made the add the example,

deals made a So some that we've upfront of reflection payments. that on also is

Chad Messer

that. I Thanks. appreciate guys. right. All Thanks,

Yiu-Nam Lau

you. Thank

Operator

from Our next with Laidlaw question Yale proceed. & Company. Please is Jen

Yale Jen

have have but and Good morning. questions And been lot two far. the A answered, thanks so I taking for congrats questions progress the on of here. the

is The KXX-XXX. first one for

that Pre-NDA filing for before the probably mid-year probably agency for and there is factors for - any the mentioned Phase, file in End have approval other approval XXXX. gating agency? you meetings is, in early -- meetings meetings the after My question your You of NDA with with

Rudolf Kwan

So a response Yale, month we follow-up not issues an are pre-NDA our studies. to limit rate response XX completions planning any NDA. get the from the meeting once ongoing request We submit see filing we do additional will that of – for

Yale Jen

difference I appreciate And file well there's slight Almirall two will know. Europe the to that. filings? good a as as between for U.S. That's Okay. time the the or

Rudolf Kwan

Yeah.

we think Almirall We filing. will in filing the I I are the that. in at responsible is leave - I in U.S. active discussion EMA for are - Europe. with They regarding for will will the filing it responsible and

Yale Jen

question last other or agreement for licensing may mutually forward you be this terminated for XXX. is terminated China seeking asset Are And partnership for Okay. you commercialization have the here have Great. the that the going any you - other plans?

Rudolf Kwan

Thank force. due sales the And it this you, a year. And of we after felt them of for felt And certain very they to the regard they we able also have termination recent with discontinue okay, large a commitments. to Yale, facing, other we were to us they able very and Jingdong that that deliver through a for to of very not then to potentially we discussion to were our overall story also that be to as be were long-term our lot they oncology partners that they would contract very felt that partner and last may for that, like would their shareholders they and the best since not they and led as of benefit that there also full certain was with quarter we good we potential and would challenges able they And good certain that mentality, since the that be sort are company early of a diligence, result know The question. of were accepted agreement. felt fulfill and be their their this. of of because nice agreements. the dermatological we to piece were a the request active have that, have nice a data opportunities, partner. that result We number a corporate promises Chongqing complete of not interest to fact our third information which the strategy in of good the or And felt

value of capture the of particular in team the this evaluation position to have program there maximum full And and I clinical things. that best good terms then opportunities. best management to even other looks very data asset, internal a program is discussions next? our that of now approach of good are will having all Now we this data good, Asia. in our we clinical the very now of having this a in the an right dermatologic be, question mean, Asia, we what capturing We additional the in pursuit very and obviously, oncology terms reconsider are feel and have approach no active these with issue also in value now the as to

Yale Jen

wrong, Great. curious question Okay. just is helpful. tag more this which I'm future guys the believe there at you And what's very I That's maybe me, retained moment? the one plans if along here, just and Correct rights. Australia that.

Rudolf Kwan

But for a of number New Actually, that, to geographic potential we're incidence -- be having very their citizens. to considers of the partners. that keratosis in Australia Zealand, major and government active point issue in with well they region actinic of is high discussion the that healthcare their said are the for known a

it's in major Athenex of partnership. of And this trying major actually engage to the Australia Now, obviously, very would interesting -- terms of the a to can overall within - the in and the capture represent even a therefore, of to partner because cities. opportunity, population But reach be is also the bulk out create a opportunity way opportunity. say, I X are easy the focused Australia

discussion, in are We certainly. active still

whether sheet opportunities of to do terms Athenex. terms of - geographic on extend outreach and based to we term balancing would it are the ourselves like the having We between table the in versus

So actively now. being considered is that right

Yale Jen

forward Okay, data great. progress the and lot congrats Thanks line look a top see shortly. and on to

Rudolf Kwan

Thank you.

Operator

muted. with question from line Kaplan is Matt, please proceed. your see and is Ladenburg next Please Our if Thalmann. Matt check

Matt Kaplan

Hi, morning. good Can now? you hear me

Operator

Yes.

Matt Kaplan

morning. Good you. Thank Great.

beyond little first, focused the in guess, the a of of Oraxol to I wanted program. company focus on you pipeline Where development the continued the Phase a III with are product? bit. as Just terms

Rudolf Kwan

Yes. Matt, here. Rudolf it's

the two indicated as Okay. directions previously. we continuation of The program is in

for So drug apart metastatic pursuing monotherapy, an cancer, we're from the indication III breast orphan Phase angiosarcoma.

other we So second cancer. studies And ongoing. is as started combination ramucirumab, in the And combination the One is two that with of has combination announced line therapy. gastric study targeted development anti-PD-X. a is combination we And the a in have therapy previously. a

focusing So that is we development right the now. line are of

Matt Kaplan

And from of Okay. Very year? terms potentially this we those good. expect programs, then them later any in data should

Rudolf Kwan

Both recruitment. programs evolving are active Yes. in

we in speak. as and cohort announced combination we regarding gastric the we cancer, are data So ramucirumab completing already some third the

combination Mayo we ongoing So The data with come soon that's stay as anti-PD-X will out tuned. Clinic. The as complete that.

Mayo cohorts X have are the initial We the in - Clinic we centers. in initiated enrollment

we'll one. So to again, expect come and we with start the progress those, - previously, that when stay Angiosarcoma again, data you we year. as out tuned as of And announced their out course the results will during study, of enrollment. it coming of all hear

Matt Kaplan

the beyond Great. in with And milestones to are the Oraxol then products Okay. respect Thank Orascovery for you. platform, what next that platform.

Rudolf Kwan

clearly breast important year, will of the milestone Oraxol this top milestone. for for get is be cancer The metastatic that result mid an line to the

to advance I in the Regarding topotecan want program. the Phase certainly, the Phase the starting the oral to eribulin, we are programs And as platform, program we well. other certainly - docetaxel milestones for II, and Oratecan

Yiu-Nam Lau

superior I as will intravenous this -- the is year. of to that to bit be data, line very because and comparison, really you a favor programs And to let middle I you an file would paclitaxel we're of that thank very clinical Dr. that indication Kwan design good most prove of Oraxol able important will in the without that say - do critical. head-to-head here think, top monotherapy, little to is imagine be to is prove X-to-X the the that that available we is And for can me to point a to like not result,

confidence then value investment that you well be when much studies, is will will the combination as better, as community easier. be creation much very the the institutions, this the because and progress well the other speed all as all have is you And me is easier better conduct emphasize I to again, of and be studies combination as prove - think much that of as let higher, then this once better, the this will well once this important. you oncologists the indications once then as for is prove

the wanted to design value is Dr. is attention. of maximum process. that the the particular to to bring then, the your clinical I for we think And and team this created by that point - ensure So capture the I key that Kwan

Matt Kaplan

And Dr. XXXX In think and the program, help next you can Great. as of there that milestones Great. Kwan we then, program question TCR-T look kind for us about last for well? Rudolf. should

Rudolf Kwan

all currently And they translating planning since Matt, in China, company-sponsored already for U.S. program, the actively submission we documentations transferring our colleagues. are of China submitted from are actually the TCR-T English those the we the and the technology IND. in IND

stay So tuned.

announced for soon submission the in ready. U.S. we as our IND are plan see the as of You

Matt Kaplan

Thanks taking question. the all Okay. for

Rudolf Kwan

Thank you.

Operator

Please is question next Our proceed. with Bank. Deutsche from Instructions] Hu Jack [Operator

Jack Hu

and morning. Good I Hi. have another one housekeeping then Dr. question for question Kwan.

The full first one data. Oraxol Phase III is

yet? question. for going actually what top share maybe And recently? name can are do also view This Oraxol? this program DHP we should that Kwan. [ph] on we sure second we going you're actually your with. - you reactivated Thank was to for your present XXX see your not got line in is in Oraxol, wasn't I-MAX this is - an China launched but you one are as full why when another capacity or drug - data but my in and What see familiar venue? mentioned filing to MEP medical in I'm first approved also, data, expert expect XXXX, You NDA expert, Dr. is XXXX, at when Can why Korea you. And [ph] what still My

Rudolf Kwan

Okay.

the answer rate has is being The readout III this the first year. the by confirmed middle first the Phase we'll that response me of study Let that question, program. overall primary endpoint and Oraxol endpoint anticipate

that continue progression-free are compounds study any the you expect in survival. and overall would oncology of full the terms survival as successful of Now will and

are be data okay. collected the are to continued patients those surviving, So because

until response to mid but improved, will be continue come And full year. available of will out data safety actually will not so the including comparison this top including by data line those overall rate the confirmed the dataset be the

publication than disclose and simply the reason they presentation ASMO just more acceptance of either or the journals result, will medical Now for that - data. we line new may the require top not acceptation need in ASCO

set but top preserving be the result, those the So for line we meetings. data for will acceptance announcing be we'll

timing once endpoint, the time In the submission with will terms the of obviously, primary line. filing, we FDA planning the be of about discuss got we NDA to

So in stay that tuned, XXXX. will happen

Regarding second the question. forgot I XXX, question on about the sorry, DHP

clinical a fact I clinical and think compound studies that mainstream in a - move either Korea. making challenge approved to obviously beyond beyond making for there is in in or The that challenge XXXX the to registration is it progress that Korea not be compound much development speaks candidate. of still to

Yiu-Nam Lau

was was dissolve I the nausea absorption is some literature. associated that And - I far then like type understanding, can my give with the the emotion you on company the powder, on lipid that dissolve the our time, that, a same at below little heard bit and of which, - based in using vomiting. more of lot data to the color a the oil to is patient to technology oil is what give orally, and the based

talking -- are it not they Korean Korea. powder will facing with according that effects was to in So in bioavailability. authorities of absorption, are is are of the approve areas Korean have because with we in it, which it my be terms understanding of understanding. And geographic have. terms regulatory will our as or of that can the data they facing understand is challenges low a we that data was a but literature, therefore, the superior we mixed meeting in lots far path other lipid package the health and what company also oral as their authority of That be when the challenges And and outside and comprehensive terms a side data technology they and

Jack Hu

Thank you.

Yiu-Nam Lau

Thank you.

Operator

to the closing management end reached to Ladies would of and I back gentlemen, turn remarks. we like it session. over for have question-and-answer our

Yiu-Nam Lau

will you Thanks, Athenex. year time the again, XXXX spent us. for be with that exciting an for

the stay exciting that and the with come exciting your and Thanks in forward so. year, look exciting of the all the within in And the we data all next attention. Athenex. or data middle some will you the your - - out We tuned time of months these expect with data to six for sharing

Operator

Thank concludes you. today's This conference.

your time, lines at and You may disconnect this for participation. you thank your

Athenex (ATNXQ) 11 Mar 192018 Q4 Earnings call transcript