Athenex (ATNXQ) 14 May 182018 Q1 Earnings call transcript

Company Profile

Participants

Johnson Lau	Chief Executive Officer
Jeffrey Yordon	President, Chief Operating Officer
Rudolph Kwan	Chief Medical Officer
Li Shen	Chief Accounting Officer (acting)
Jim Polson	Investor Relations
Kennen MacKay	RBC Capital Markets
Chad Messer	Needham & Company
Yale Jen	Laidlaw & Company
Matt Kaplan	Ladenburg Thalmann
David Van Gerk	private investor

Call transcript

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Operator

Good day ladies and gentlemen and welcome to the first quarter 2018 Athenex earnings conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question and answer session and instructions will follow at that time. If anyone should require assistance during the conference, please press star and then zero on your touchtone telephone.

As a reminder, this conference is being recorded. to conference like to now would hand over the Mr. I Investor Relations. Polson, Jim Sir, you begin. may

Jim Polson

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

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

turn Accounting I’ll Chief the Li can database Kwan, remarks. questions call Lau, answer Medical will to Dr. the Yordon, at in Rudolph our be are www.sec.gov the Executive to that, morning joined Officer; Johnson several Jeff Shen, Operating find Chief EDGAR by over Officer, for acting website Officer; we other Chief and Officer; available in Section who of Dr. Investors prepared filings comments. Chief introductory or executives after With Johnson the our You www.athenex.com. at This SEC

Johnson Lau

generated start joining momentum on to public year be thanks pleased a Good and in strong to as inaugural the for everyone a I’m building today. our company. and morning accomplishments we us XXXX reporting

for start from clinical business. Phase XXXX some analysis as and made breast and detailed we from the positive the earnings for briefly our a have across clinical first a by first interim colleagues Oraxol overview call, cancer. In over U.S. it recent FDA Let for platform, we met our the quarter the feedback III trial highlights design to the trial received of metastatic we on for also on to my year-end first progress in second me then discussed target handing enrollment the speaking orascovery

the our patients early patients. year as target exceeded enrolled trial XXX fact, In than has XXX and of as this currently trial of February the more has

XXXX. expect this analysis interim to in of continue patients We XXX second of the results from the third first quarter

our for are soon. blood a the U.K. of has for of to or Access the innovative us Additionally, of designation form the by we we for the has malignant U.S. and is towards the scheme FDA planning U.K., promising and PIM program received updates paclitaxel-responsive strategy. the and providing Early rare medicine, designation to of overall drug recently announced will NHS vessel application working orphan of for our of tumors, global treatment This Oraxol granted registration cancer. in our In be to all global further testament you the step two Medicine team angiosarcoma, in Oraxol a the the validates development of Oraxol strategy quality multi-pronged

this for KXX-XXX year. patient platform, with the well the Dr. In a orascovery Chinese clinical of to two represents addition, record remind which time speak our start developments we this In is third top want actinic will six line that under for in later Medical China the expected enrollment months, of quarter of ahead an kind clinical trials Chief us Officer further ointment call. action. to Phase Kwan, in FDA the platform studies for awarded our IND Rudolph in results indications keratosis Src-kinase the in to in III completed schedule of

we worth are the partner strategic We from it’s partner, KSX-XXX, we for which of the is benefits our and will clinical pipeline. schedule our progress ahead this very with we of strong a late encouraging trials, for on testament and collaboration. stage believe development our closely excited good are continue our I clinical well team very about underscoring Almirall, work also of to that to realize the our

looking this are accelerating and progress momentum investment and We by to in clinical candidate. our this promising continue focus

from For generated inclusive agreement year-over-year. $XX.X our $X.X million $XX.X from quarter an the revenue million, the and $XX with licensing financials, commercial we million Almirall of generated first with of segment, associated increase million

into XXX(b) building sales, expanding passed and site global advancing pipeline, and that inspection the that of our in global was on oncology year, week, research and all distribution. our on API of as as according we balance I’m breakeven and Dunkirk, target the support million last approach [indiscernible] our million U.S. [indiscernible] to product million our Furthermore, China million we and conservative progressing we initiatives first year, achieve very close platform proud and to on focusing Buffalo or the Had the marketing the FDA We pleased both with of quarter. plan planned, facilities. remain development $X is as quarter and from there candidates, our sites API conditions capabilities we $X $XX the to as of well and Chongqing, [indiscernible] $XX Almirall, associated U.S. Chongqing received on facility very our to this inspection for FDA clinical deferred citations. adjacent has but that and revenue. as recognized were given passed would team this Buffalo zero and revenue, have recognize are are payment, fact, facility Heading out can and oncology commercial a all In of taking certain we our remain leveraging focused been been just

field make Officer, patient Mr. confidence all we the Jeff our Given further and of are as the in update to of on also will the ourselves on first strengthen efforts. additional a oncology major a position pipeline accomplishments clinical our We’ll have our Operating Chief turn value time, all we over further overview and you two call that, during of of opportunities and Phase Yordon commercial With our III for to recruitment programs the evaluating our create more delivery programs Jeff? for continue with Phase III as leader to successful we detailed quarter. the I progress our stakeholders. to to

Jeffrey Yordon

revenue Thank generated significant the performance our you, and first which inclusive by of providing business this of from had made we’ve like Johnson, with our agreement detail I’d record generated start made strong our fee bit more and Almirall. licensing a across progress across morning on quarter. proprietary quarter to everybody. a a We we both very good quarter platforms in of a progress

of XX% deal and rates payment agreement Almirall out payments the with Our with increased Athenex terms a million the ultimately benefits. in to received with landmark Under will which incremental yield first total at near-term milestone continues sales. million quarter annual royalty of in Almirall, sales $XX net payments, starting based with indications, with of XXXX the royalty on additional $XX increases

upfront clinical million that revenue While Almirall recognizing Almirall $XX $XX from amount is with fee $X licensing our quarter data. as is contingent the the recorded of the in million remaining upon deferred million, with first being confirmation the initial during satisfied we’re only

significant we collaborating We are specialty forward XXX(b) our look new to in forward injectable across as business very Almirall partnership and we our excited the products with commercial and move units. business this launch both and about business

we fiscal new quarter of commercial During this the products first units. eight year, our launched from

markets products As products outsourced APS, Pharmaceutical with whole, XXX(b) a SKUs, XX Pharma our APD Solutions five or currently or now currently and facility Athenex Division, markets SKUs. with Athenex XX XX business,

and vancomycin quarter We of are also contributors which revenue pleased the significant fill the help to both to azithromycin, shortage U.S. were performance. opportunity first

We the both of CGMP continue the by United plants States in chain supply manufacturing take China. as our planned to strengthen steps with large-scale to and development continuing

New result our mission strong proprietary York a and underway plan I fact mention to York, comprehensive facility partnership As new manufactured we we on is with quarter the and therapies. immediately continues want the XXXX. oncology-focused will eventually facility. of expect be there our innovative of effective in private-public to partnerships to first facility our to this be overhead be products have the by and our construction well to This developing of completed absorb the that State critical of New Dunkirk,

API the could be ahead completed is of quarter. in Chongqing and by fourth the facility start of Additionally, target the

which extremely pleased in are We as a of our inspections FDA, quarter. XXX(b) speed New by first the serves announce FDA major our bump inspection to for many U.S. facility Clarence, the successful York several this U.S. very positive end, completed a in To competitors.

we Finally, the our zero strength and extremely with citations, party relevant our proprietary for products. FDA Athenex Chongqing compliance API to the is and Polymed any material completed inspection U.S. remarkable of This raw is major on critical our last proprietary not supplies is supplier because products. the highlights which a accomplishment two week first extremely This third facility dependent for key qualifications. Polymed in are

As the acutely and we development a of with and good cancer centers comprehensive company, commercialization products, focused spending we on the for of treatment and looking to are of are deal and related time oncology adjunct oncology a opportunities discovery, improve conditions. cancer

laying capabilities revenue as Our In they we fiscal commercial of are strong platform interim, solid when commercial are the will become approved. exhibited proprietary an this our critical to drug supporting year. extremely performance candidates foundation by

over build future will decision highlights With the fund leading on that, Rudolph? provide revenue and call the to our the platform to Athenex a oncology our Officer commercial efforts proprietary view the vital clinical of generate to to in these I’ll make Medical our as clinical an bridge who we a eventual and treatments as Chief commercialization of platforms work hand platform Rudolph We Kwan, provider business. products. both and continue important to to opportunity for help R&D to proprietary makers some

Rudolph Kwan

Jeff. Thanks

drug our highlight Oraxol orascovery me start angiosarcoma. the In candidate Oraxol, of Let our in program to designation we This the platform. detail announced indications is the and parallel additional receipt for some of safety Oraxol. shown has program. already for designation our development with promising expand Oraxol efficacy in orphan The treatment on lead and with for indications I’ll gastric commitment April, represents profile. metastatic our cancer breast cancer which a clinical

saw dosing stable XX% for evaluable Among third in of safety quarter another our report second we the during for the we cancer, analysis for response key We meeting interim a clinical treatment cancer breast in first expect trial There partial peripheral in Oraxol of the no efficacy neuropathy. putting for quarter, the we III and first clinical Oraxol breast shortly. in and disease progressive schedule XX% metastatic the clinical and on us launch In on February, are trial Phase Reflecting angiosarcoma for of in January announced XX orascovery enrollment cohort target data developments cohort. Oraxol to encouraging we In was of disease. XX for a with trial announced XXXX. preliminary back no in ramucirumab, the is second Taiwan. patients, cancer, platform, patients of in which a first combination other across is for completed patients developments our gastric and the

Our are in for a formulation soon. docetaxel, China in the Oraxol to position clinical the planning advance is irinotecan, these which progressing formulation are programs should studies and stage be oral we soon. oral very clinical very In starting of there an Oradoxel, well [indiscernible] an and pretty and are Oratecan, final programs in we

IND of Finally by for the eribulin are the platform, to XXXX. end orascovery of planning be the filed we oral

days KXX-XXX II the in the with day-XX of KXX-XXX February Dermatology of ointment excellent ointment American lesions a San Academy for with to Src-kinase clinical announced at clearance we Meeting. at Turning in Annual tolerability. Diego AK five for high Treatment complete rate Phase inhibition achieved results platform,

top quarter available third the XXXX. studies of be of expect the Phase to III data We line in that two

schedules the to aggressive me to clinical team. be ahead continue targets, of by is excellent Let already planning execution close our of in testament that to which and enrollment reiterating a we our regards

in for we first investments Li? Li We our financial are momentum. clinical this an maintain to Shen, positive programs our results. of our progress the over With Chief by that, and call Accounting overview excited very our turn are Officer to quarter I’ll acting accelerating

Li Shen

fees, be sold confirm current ago. Oraxol the balance first through million of XXX(b) to and Thanks product million $XX.X in a from going increase products, $XX.X million the Revenue costs $XX same trials $X.X fees million million fees primarily in position, for walk API specialty development compensation for March to million quarter of to million XXXX. licensing that quarter and million for in increase satisfactory products an when to $XX $XX.X $X.X The of note million $X.X period year. This related products. the year through expenses. KX-XX of was our of Gland $X $X.X SG&A million R&D commercial XX, Hanmi in million of increase and due The collaboration and our sheet data is confirmed million three the $X the next from and licensing XXXX decreased a revenue million Rudolph. of our compensation Almirall. to our first products expenses, platform, was expectations to R&D costs related but increase expenses and $X.X quarter compared for primarily ointment, to to $X.X and licensing $X.X and upfront was of professional by million, $XX sales office studies year expenses with the $X.X and for were related compared million a marketing a and Phase were results, the was study for fee was to the increase $X.X last increase increase increase to months I’m in with pre-clinical million remaining upfront $XX.X contingent quarter Almirall, Please III our and proprietary in increase over agreement million $X.X of million increase XXX(b) primarily attributable to due ended supplies as million $X.X clinical decrease the million, clinical expenses drug $X.X million of just to recognized the Jeff our launch mentioned, offset initial was first expenses, Almirall only

working as associated balance of our position remain the XXXX We fund XX, with December investments $XXX.X focused our cash sheet, to platform, Now million compared commercial well using XXXX. purposes. $XX March short-term as corporate turning were as of cash the million capital, pipeline and equivalents to clinical and XX, on costs cash, general to as

to of Johnson for range full-year million. are I’ll look the some With reaffirming of final $XXX expectation to comments. it in As towards our million the XXXX, we remainder now we turn that, revenue $XXX back

Johnson Lau

remarks you, to Thank call Li. our questions. the I’ll prepared we open before conclude

oncology-focused and support As clinical the look of a company, for of you on currently remain to focused therapies on underway acutely III of both your work and commercialization capabilities sharing upcoming across Phase be we our I’ll up that, a call to milestones Athenex our over forward our two around turn specifically platforms. the available. to makes questions. to team so With of. across I whose I’m would thank when continued all we like to and Thank trials development business Operator? globe operational the hard the the and clinical proud part

Operator

comes of question first the line Our Kennen instructions] of [Operator from RBC. MacKay

Your line is open.

Kennen MacKay

that taking question think that early were how the into you many enrolled correctly enrollment. for this you be analysis? Oraxol you the we take for you to did Johnson, mentioned clarify and trial, thanks analysis Thank see you. also on of that, when for I Hi, hear help trial the could second interim Phase trial could you the trial? III the analysis question. interim there patients that when that potentially when I patients understand then enable again, would Could XXX and, us that A stopped would success. that needed potentially third are could be

Johnson Lau

problem. this answer your to Rudolph No our Officer turn I Kwan, Chief will Dr. questions. to Medical both

Rudolph Kwan

The Kennen. passed Hi enrollment patients. XXX

There weeks. XXX analysis. interim of conducted on they the analysis will reach defining is second XX endpoint The interim third evaluable patients be once no

is on third The is a and patients. final based analysis analysis evaluable XXX

Kennen MacKay

XXX you we the maybe be when And interim did Kwan, based second you remind anticipating Dr. potentially us could just analysis when patients? reach on could

Rudolph Kwan

quarter Third year. this

Kennen MacKay

much. very you Thank

Johnson Lau

we hopefully second get analysis this do probably in to will very to now, can--if the the ensure well. need--we that that quarter late interim results hopefully--we I upside that so with clinical to are accelerating very our design, highlight third have very regard be accelerate And are planning to complete also we’ll study confident study, the year. with nice a completed with as possible we also soon want we potential to but that study are entire we

Kennen MacKay

trial can IV early the a for versus or to registrational ask, be accomplished if the you what much to in need internal Oraxol arm, success filing I global arm processes paclitaxel and rate response additional potential the halt Can do would higher ask I filing? for FDA see is

Johnson Lau

Yes, answer let me question. this

with the know we study and of progress happy and fast, the that First very investigators recruitment signal. are is are should a the excited clinical all, is to nice fast the and usually is when evolving very very me rate

P-values, taking favorable very do can second to hit may have and the the it In we encourage addition, data certain what a in assuming obviously that safety look they they way, we board when analysis, monitoring is will and then us consider at interim should before as are--they like to will decision to can. us we [indiscernible] ensure as talk study, stop but that the study they will otherwise encourage to fast FDA the advantage U.S. continue obviously of actually our they we we

couple are there we’ll and delighted. and tells very the our likes us, one, which ahead a data file be FDA obviously NDA, possibilities. Now really go of Number

of possibility that can we on want ensure show why entire actually and us FDA well Second is study you that more to and very important, one, everything the But will track FDA is third don’t to which and continue is is submission. complete then the actually, the way, you say, data. data have then the it likes look you’re very advancing this it. a but like looks rolling a promising investigator at very it and in way you also show your submit evaluation during that data Why set of product, fast, also don’t entire the us then the

study. to have the In allow in our are now, the right with that that discussion to for we be conjunction to for trying the capture and to the FDA. also with able all opportunities to like mitigate pace and would us maximize we’ll this trying are to we U.S. advancing we return I that investors think advance potential therefore risks

Kennen MacKay

so fully that time so Got about rate, by that trial It be the that the things from enrollment initial the that is you. interim four-month thinking seems enrolled is response completed there is overall like the far, on pace of could XXX potential sort patients, analysis correctly?

Johnson Lau

you know been Kennen, always results. management able our conservative, that to we certainly our very and deliver style is have

enrollment is year. next sometime plan complete the to quarter original Our second

potential additional assuming You possibility, that get hitting that XXX, and are we I we’ll can there already provide very to to see is that think even need good XXX, we that upside surprises. a

Kennen MacKay

given Got the Oraxol trial, it’s one understand final if higher just trial and efficacious about us within spent increased on-target AUC wondering physicians be range, III such [indiscernible] getting that just should you. something seeing South used, can being the the event which But neutropenia, that’s an America, getting how on or with effect, higher trial same ask to is should be some can that. is we question, anticipating help as seen potential with the in adverse may the neutropenia obviously. potentially patients an deal Phase wondering what time that versus of that sort If management and this I if we in you help that conducted done paclitaxel is just is of and think

Rudolph Kwan

question. the neutropenia that believe very We correlation in with Kennen, efficacy. definitely good is

we with see from have analysis paclitaxel of understand implemented the after interim the criteria. positive and that to the the paclitaxel some suitable inclusion-exclusion We last implementation. are We of those managed also can year, already so starting results oral IV better handling be first

a we neutropenia. I think can very good excellent to tell the while have plan efficacy how will go we we the the them FDA, going controlling to maintain forward when

Johnson Lau

that conservative and very imagine, can authorities as vocal. should without Kellen, presenting data are a too we all being is approach the regulatory you like then we the only what take

the the or taking vocal that analyze affect definitely to this too people biased. be being because the are way investigators the can sometimes position results We who

ahead to data objective approved get is the instead Our of drug schedule. of providing

I is important think to something that very for consider. us

countries with U.K. of positive, is that from approach Zealand Taiwan, way a various the that also been regard the health full a New demonstrated the FDA, and other the and regulatory good in our of effect has they looks to we’re Chinese the product’s MHRA, that be given path. and Now the endorsements, U.S. to provide to lot promising, are that this regulatory taking, support very authorities which getting authorities FDA, our support the including very with indication like regard profile feedback then fact they consistently

Kennen MacKay

I’ll back hop the Wonderful. Thanks in so much, queue. and

Johnson Lau

Thank you.

Operator

you. Thank

next with Needham Chad Our of comes & from line the question Company. Messer

line Your is open.

Chad Messer

have third Thanks upcoming the programs for with taking good excited On about your of eribulin readouts the some orascovery, and my morning. oncology we pipeline. Great, to you’ve question, oral very an added quarter. your that in

us what and is. could through your for Just behind product think wondering you that you thoughts if the walk potential choice that

Johnson Lau

and best our down did at but you to and have balance We can for benefit many candidate with for that a to it one boiled and what obviously the add choices, this more, shareholders our have thank your obviously the at stakeholders. also and it do time, company. Chad, We is also derive question. a required to we regard resources stage the can of we

which the share for Eisai did This product like in me let making that getting paclitaxel-resistant is chemical and good would very Now derived number they to tumors. job few derive terms it of Number it of it very very further products this one, terms against two, a useful has three, product important very from naturally Number eribulin. say it patients. occurring active. a interesting active oncology better, of is and in I profiles. properties very is even

oral all synthetic different we’re we to in for product. always product is that doing, absorption be importantly, able with looked at profile, into pure very the we’re fashion still animal produce single able candidate; Eisai would we We physical that an together. choice. that means suitable how putting can a in the therefore profile, chemical can animal is unfortunately paclitaxel-resistant and many it data forward, tumor, this that we it same on models, properties, more time a the the and tested is tried by made that found against to you the pharmacological to do fact think the digit the generated Now, That the good excellent models, make intravenous move be in come we be candidate we why very I is different the properties, on why it and based will and size, that them imagine have product up obviously were the this this the that route, feel a to reason to active we but was the an things at we

Jeffrey Yordon

anticipate Also it’ll the the that revenue a our Chad, should be for billion-dollar drug cross shareholders. we mark very, early so next year, opportunity good very

Chad Messer

a All time him thank I I much better its sounds I posed next right, had to to rationale I it. when figured out been one to but quarterly that has and to a you. ask It own saw trying guys a that very correct. I’ve like suggested products earnings after it Jeff business you strong future; being was is the the your commercial reason he there. recently, on that in is one figure for I realize strong generate own. how support of cash strategic part in existence, could your This

have your about or because sure products. proprietary there’s potential different - to of that a what products upfront things give wondering any me lot is and launching guys something think the conglomeration from lot of ahead you’re if even could this generation makes costs way of commercial there pursuing cash COGS ranges there, you a fluctuating You sense but was I’m you’re of that and a opportunities

Jeffrey Yordon

on Chad, in some give on should me traditional that. let guidelines, margin area. compounded be The XXX(b), that API the margin you the XX% Yes, product to

products there. XX%, more competitive talk we in chosen a and can a from you’re products. material more products supplying XX% raw a bunch products injectable are traditional Those tremendous terms that a approach XX%, looking we vial, products but have being as of and of finished and in on terms that is margin, barriers margins products compounding now to have about at you’re are in difference If products, so are probably entry that amount and of there you about help about huge are the XX%. margins we the margins manufacturing, figure that both of The we shortage those

and we begin commercial a sit So we’re It’s our to to forward dollars also to willing we give will we contribute you margin. some believe and overhead all of of blended program. down you out a give how interesting but cover that that all we as the move clinical not to only significant, works will breakout

Johnson Lau

more Chad, a commercialization component, me products we going as fact marketing the that we two to plan market have if own proprietary a think one need have well add for also evolve important regard also plan our let to you us it, products’ to that with then nicely, is follow, about plan. number to as game with to

dollars and only fact in are very of when having regard [indiscernible] The we Obviously the of us our significant. just that plan position commercialization set people have to to that plan saving short a with do already time proprietary to together Now, to cost millions that very, and time It and savings to multiple regard the team is can savings with a to our fact place successful, testimony marketing cost we the we up to are a using the in and that we have of cost saving already product outlet the completed the also consultant working with the pharma. plan got big is instead commitment puts of a program. a period and time. in switch will party terms our in third good deal Oraxol

the people the is talked and time, we same our impressed to KX-XX other partner, what that to actinic marketing plan with keratosis, time do. well why commitment us at Almirall, reasons to plan for one as as Our commercialization were can at so the key regard of the

the so together value intangible but n team success, the very that proprietary launch the with the products also both is our regard join able see created think the Dr. having for is tangible being ensure to to to are will intangible number fact, Kwan that can what by to of support organization. bring be a I In terms think important will developed be to our product Jeff’s we forces that team the of I

Chad Messer

what unique up with through just you what I’m one holding specifically releasing - cash spend not strategy to or of you’re one there that housekeeping reserve. the sort a on that to you share meet data I can know have time you me Look contractually from them guys that. Is waking about taking appreciate more what the you, what anything the you the with is? happy you are longer in synergies say I million take being your share Maybe don’t last Almirall from it I here. $X about can more reserve. and would strategic

Johnson Lau

have I Actually happened either answer payment if the that have the point us get data things, the are down deal, our challenge to target what to regard that partner, very the that was useful trying other was not generated then different other not time we [indiscernible] to will really all example that we the the $XX Basically somewhere the a what deal, at so on when already conditions, upfront Almirall, would that but access be let in fact to. we with like the to the like negotiated ideal, question. the may for data of sales or ideal these that that cut me million, lot is road

to, amount money the data Now certain based to own, ways would to obviously is we example, a be we that we agreement will to anything. there we way, any contract, amicable launching as separate for that into their in of always need then would agree an would of but data on our a an pay for that the time generated, that, prepare our be our which say say that to we like get if in if want product terms not losing necessary, get don’t so on

So but payment, why them, elected that we to that it approach, talking million, circumstance, there most to we we be $XX about. the to accountants ceiling under our will is million. up is would a the pick for to is up if only and data $XX million, of be million, since but lot to they book $X pay back reason want from to a condition us instead actually decided it’s ideal are conservative of $X a there The booking payment would that the get

Chad Messer

have Okay, all is so treat it so safe like from assume million comes sounds study, you’ll this comes third quarter? out the right, data to how to that $X decided all is in related shortly that data after to this this out the

Johnson Lau

excited. get you lot Phase a when XXX based be positive, III big think to the positive, imagine The give I period would you get that confidence at of time our in out of we certain is a with data. people more comes our way encourage data, Phase already I II to you contract around confidence patients will and even them are to them into, can have the that ourselves on very study programs, allows can to review only positive actually that should going the results, fact very Phase extending a Certainly data it to III in on the if when two regard which where XXX you anything, look and for based

Chad Messer

much. Thanks so doubt. No

Johnson Lau

Thank you.

Operator

Thank you.

the of comes next Jen Yale Company. line from of & question Our Laidlaw

is line Your open.

Yale Jen

to with the Thanks just I’m questions Maybe on taking quarter. good the with start pretty and move question along others. for a going housekeeping and congrats

for specifically, the revenue can seen for is not what the $XX.X bit million this for this First down the revenue what be would being example is or $XX little break revenue more upfront be and the to seen deferred quarter, product you would and million be quarter? a

Johnson Lau

$XX first operation $XX.X The the as from licensing is Let for deferred is Almirall, generated million. the not Li getting million the million number me total, that part million of being as that first accounted $X million answer fees looking $XX.X will Is in are commercial be--shown in for? you’re $XX.X while that data. the quarter.

Yale Jen

looking number I’m the sorry? that’s Yes, I’m for.

Johnson Lau

if quarter, in add million should you treated is you deferred, it $XX.X first if million. the really that as So count $X it and the be

Yale Jen

That’s helpful. great. very Okay,

count share net for base quarter? Second, the per share what’s the calculating loss this again for on the side, housekeeping

Johnson Lau

have We do to right the you number? Li, going get the are you now. number

Li Shen

do. Yes, X.XX. It’s I

Johnson Lau

shares count outstanding. shares The No, share base. total outstanding,

Li Shen

Shares outstanding current for this quarter?

Yale Jen

Yes please.

Li Shen

XX,XXX,XXX. It is

Yale Jen

Okay, just two - questions. appreciate great. clinical Maybe tee to very one Down that. helpful, that’s or a

therapeutic a as you possibilities? or will benefit the the start successful, benefits line all, first be existing suggesting in could additional data that angiosarcoma of have all, look of, the potential you you to as well forward extension. you starting as terms bit and study more into going are First as regulatory you the is what indication impact to once be status study, an elaborate that terms mentioned separate or going a of in Could of little a

Rudolph Kwan

IV liability, but very only The ideal. effects the of blood are treatments The long. usually short a is is of that vessel. because not term and the for Angiosarcoma tumor maintain malignant current treatment paclitaxel, cannot has some side unfortunately benefit treatment they Definitely.

paclitaxel that both potential that generated pre-clinical convinced benefit and FDA data animal oral upside We data designated the has orphan have and they drug thus the indication. significant the

in start difficult have cancer. would more will significant this tolerable to studies clinical the We anticipating long treat Oraxol, being a that very term, benefit

along more drug basically on Now, dialogue the indication a FDA, orphan can lot we the with it the with indication. questions element basis to a That potential of on allows get benefit, lot the difficult regulatory door comes some benefit the opens global that a question? It to that the talk an fast track of is of for tremendous. related is the but authorities. more answer important us in your Does of health importantly

Yale Jen

successful is the the drug you beyond in if give is successful, cancer ground least oral exploring oral the will the let’s go presumably breast drug could you are whenever be the Yes, indications that say--also the the IV suggest I’ll that oncology be, IV indications better sure. board use that potential--lay other which indication that you’ve to you the assume the better; at see that bit been possibly suggesting Would let’s all in drug, moment? Maybe at drug. makes and it so across to be words, in two a was that will have than just little that whether angiosarcoma the if add then which will sense,

Johnson Lau

some the regulatory look this look read You company not is our of the off we after represents regulatory single medicine authorities of path of but just if way, using realize using start the designation, fact the Promising Medicine that something multiple this it our to the paths will data. strength. and way. of at saying now U.K. us in to integration people’s is experience in nice If companies strategy health a to ensuring promising terms authority our there a approach using we but our delighted that they mind, our starts regulatory is success I’m how it this way, at helping provide we innovative are Innovative part U.K. in globally that be say as but terms only very excited other the now they part the drug, called and certainly that global ahead develop of a are certainly a

enjoying be results generate regulatory we through experience our path. will We the appropriate that terms of in the can

Yale Jen

well inspection, proprietary China, both mentioned great. done States Chongqing just suggesting you the it if helpful. is the manufactured Maybe the all United the really part these being as part once successful, passed Okay, both products, that very the be manufacture last and process the here has the will question the your also will of be facility, also in a in as different so facilities That’s facility, drug, continents? that of you are or Polymed, with in things, you mentioned finished, Dunkirk to

Jeffrey Yordon

The of bunch eventually begin business absorb is Yes, available products moved overhead will plus a of finished absorb, we finished be That’s finished that that facility products its that, into our facility can talk Dunkirk about immediately have that. solution plus we to proprietary will as making all there. we’ll be bought soon the doing product. our and in have to let’s XXX(b) drugs,

we’re is is the relevant party. manufactured of Oraxol on about our completely and material, we raw that and follow-on are third being facility, not the part of that for that’s a talking essential paclitaxel product most product, the so Chongqing our dependent and In major terms there docetaxel,

our We and It’s be ourselves. are in. integrated a supply can back raw phenomenal position to material

Johnson Lau

good that ensuring back-up that to that’s sizeable make transfer, is product, a that the sizeable to the is interruptions contemplate plants are different levels the that is that this of will is going ready, product no the is be also important or have can answer to we to address. other a very and We second organization ensure patients there answer manufacturing case want sure have we that planning sort contract one. we we just own a from the don’t time oncology support further for is from for geographic to that--the by scale an two we sizeable Jeff’s component some to to one very way a initial one question we time. plant have products and manufacturing in your without just supply, Yes, Number number area. ensure essentially to there’s that that take - to Also our interruption to essential supply is do we up in that is existing it to have

have on strategy. to plan is we supply, we our medicines, important that that For overall ensure they how are in and

Jeffrey Yordon

is plan on terms They in of contractually. agreement and we the need last how State exactly New to the of are we payments is following complying on the supposed we that making Yale, are as everything our York and is people, they're target. thing hiring that

very it. about We’re excited

Yale Jen

Okay, progress. great. year. and the quarter see forward Thanks in this data the a look congrats I the to lot, again on all third

Johnson Lau

Thank you.

Operator

Thank you.

press reminder, a telephone. gentlemen, and have the a one and this at ladies you on As please if your the time, number star key question touchtone

is Kaplan line Matt next from Our question Ladenburg. of the of

open. Your line is

Matt Kaplan

guys. during Congrats on Hi, the quarter. the progress morning good

Johnson Lau

Thank you.

Matt Kaplan

You’re welcome.

you’re Phase statistical about the the assumptions bit in to interim you III about little modeling a second second Can probability more the what how bit of tell and of and the bit some little analysis. there? on early analysis efficacy Oraxol a should for interim trial dig and us the little think how to stopping we potential are a wanted Just

Johnson Lau

question. your answer will Kwan Dr.

Rudolph Kwan

on Matt, based general to the X.XX. P-value the is design study the XXX of equal patients,

the close alpha to the so keep analyses, the the interim final that interim is have analysis is is so it probability basically the that We data, they at me that indication is X.XX, The analysis. second very, split an is reasonable two interim gives data probably that futility, analysis us details we’d second of fast in there and look is so alpha spent. interim toward that disclosing a parameters work without at achieving The we of spent first analysis looking the analysis. interim how first the very interim analysis see the second so interim with alpha, little DSMB should there

always is appropriate comment points. for probably me that fine on I think to the

Matt Kaplan

Perfect, that’s helpful.

Johnson Lau

design based make the to when at so therefore as very have we second study will been, we we whatever we to going to complete FDA’s assume, want conservative a to the just to be are the fact but that high is level that analysis, we and response it rule, capture the confidence we before, if the I then you when stopping did and upside think that stopping study a the be a we have of accelerating we the in Matt, confidence that rule get opportunity. positioned side that discussed very should our build will hit on second always can level well a imagine, we study, highlights interim interim, the of after then nice appropriate very and be high full the sure the as there very are confidence be

Matt Kaplan

those us we two III, looking your actinic the KXX-XXX, Great, also should endpoints in on thanks. Phase terms be Phase understand for the of for in help trials just III ointment keratosis, studies. Then for what

Rudolph Kwan

XX, studies, Okay, that five treatment so is AK response the studies endpoint endpoints, rate for FDA at approve a used and the exactly are are other treatment. two to complete of day days same Basically and Picato the who III have last after patients compounds identical like day of They it received treatments. Phase identical has identical. in the the

basis, but okay - case has not days the have ointment, primary treatment not you and of completely lesion to remaining, eight at It four our the gone, and regular and response endpoint observe they to one a complete still XX. be if just day it’s you who of five a them on have again then in lesions give beginning, you So the the is then that’s look them at patients counted. in

achieve at look So III Traditionally in control. we power been studies so XX in control by in to think a T approved for. help? III X%, the comfortable the have we should targeted around, set vehicle FDA range we from data, that response our I Phase complete our around of Phase indication Phase variable to saw our in are that reasonably depending that studies the and vehicle zero II, the II Phase the we Does XX% over response up on both XX%

Matt Kaplan

That’s and great, for detail, Thank good the you added luck. yes.

Johnson Lau

Thank you.

Operator

question comes line next investor. our David from and you, Thank an the of [ph], Van Gerk

line open. is Your

David Van Gerk

forward Rudy. I’m Johnson, you next in to looking hi Hi month. seeing person

Johnson Lau

Good morning.

David Van Gerk

you’re a the what have to the had wondering outcome reduced with results on we similar expect in with that question believe that could specifically to be deliver better do you’re seeing Phase any I detail trial a Oratecan, just maybe Oraxol regarding will the trial, able I you. Thank that, the an or you you studies AK Then the compared on or share Oratecan and and target. toxicity, reason I’m share and if KXX-XXX you on a the to on wondering at kind at as more know IV? I secondary any to the way I’m a expansion when the just looked we any there going first look of possibilities on the was maybe ointment. are label dose secondly, additional convenient if can for can

Rudolph Kwan

Oratecan, the Ib in Okay David, is II very the study Phase U.S. progressing study, the you questions. well. for thank Phase

information original achieve, moving study at have in highest the with PK. are did, is the progressing program We the that MTD. tell dosing U.S. it, we to did Hanmi and once quite dividing multiple we mention they we which base very I docetaxel alone you dose well of can is that which the MTD the is consistent a in dosing yet in interesting the regimen, a would by not not we also reach make MTD, use reached because oral the haven’t I hit because still exciting, along quite does regimen, how we for so met think the

program oral from is the and look for get the borne and paclitaxel, so really platform, orasovery the eribulin Oratecan and being to oral moving the the obviously program, now So data, the is that further well. when eribulin, Oratecan data Oradoxel with we HM forward the paclitaxel the

we do been you the we pre-clinical you oral years KXX-XXX, we got talking planning. kind and the focus approved to that always out if once indication, can with lot and I’ve remember in [indiscernible] reaching of did a the data, paclitaxel on we and oncology we that is of going in remember combining are the synergy I roll about Oraxol a that KXX-XXX our think Now point, data that have that path time last did

Johnson Lau

to in share focused on promised, are that David, thing investors that with are summary most programs, is you every III Phase they that since I we So single just all want advancing. our

Your well really, regard received better. the advancing very II with to and Phase and as really question is according is I/Phase everything or well - to schedule, results expected

have established that because to designed, plan we approach that deliver game a be and question second the best when It the the we is but KX-LX do we about which effective the is approach results follow to our very the the level Your process. to preparation, have that should look to according schedule time combination, Oraxol will getting high into most synergy, forgot to oral shareholders. haven’t that logical to approval be will of good is

David Van Gerk

met, thing so promises over one learned I’ve there. Well, here, question is promises kept years the no

leaning I towards it have about. to psoriasis before so went though, as On the the--didn’t was we bit the on we was over little I AK, a ointment was the KXX-XXX, talking side early target an more that

Johnson Lau

bit You question. very ask time good the being. little a it keep to Allow a for me confidential

us. keep on watching Just

David Van Gerk

to All next right, forward month. looking it. you Got guys seeing

Johnson Lau

Thank you, David.

David Van Gerk

right. year. guys. Thanks exciting All been It’s an

Johnson Lau

your Thank for time. you

Operator

like there over are Thank closing turn this further CEO I’d no at to conference for to you, back the remarks. and Lau, questions. time Johnson

Johnson Lau

much. all time. your Thank you Thank for very you

time to we’ll and all the for we’re your and excited you and would results to the We’re Again, time, goodbye. continue come. results I in thank you with your ensure like to working that deliver thank to to many years hard going

Operator

for thank participation gentlemen, you conference. program. conclude This in your does and the today’s Ladies

now a great You have Everyone disconnect. day. may

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