Athenex (ATNXQ) 1 Mar 212020 Q4 Earnings call transcript

Company Profile

Participants

Steve Rubis	Senior Director of Investor Relations
Johnson Lau	Chief Executive Officer
Jeff Yordon	Chief Operating Officer
Rudolf Kwan	Chief Medical Officer
Randoll Sze	Chief Financial Officer
Umer Raffat	Evercore ISI
Jonathan Chang	SVB Leerink
Kennen MacKay	RBC Capital Markets
Robyn Karnauskas	Truist Securities
Kevin DeGeeter	Oppenheimer
Yale Jen	Laidlaw & Company

Call transcript

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings and welcome to the Athenex, Inc. Fourth Quarter and Fiscal Year 2020 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Steve Rubis, Senior Director of Investor Relations for Athenex. you. Thank

begin. may You

Steve Rubis

thank published joining two and This conference morning, we press you morning our for call. Good releases.

Oral The a first for complete received Paclitaxel. response letter announces from the that we FDA

of releases and announces second XXXX These earlier on are our morning quarter our we crossed The for this an as full website. the update wire as will on the well a Today, XXXX. review A fourth financial financial website. year Athenex’s archived year results. replay quarter fourth and available this news be results call and also company on full business will of the provide

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

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

Johnson Lau

announced our its before Officer, for the letter over our Oral FDA the received a letter response related regarding update product turning the we to the Kwan. Klisyri from issued drug that Medical and Steve. response launch you, Thank Paclitaxel. an new approved provide Chief Rudolf Oral morning, and application Paclitaxel FDA will This complete we call Dr. to first I complete

Kwan that remain and value provide disappointed profile a the neutropenia-related Oral the this about expressed trial. We and agency all in well-controlled in uncertainty X associated primary the setting regard call. clinical FDA efficacy central exploring unlock a response the later complete will Paclitaxel Phase demonstrated to elaborate review the FDA’s issues the is from on increase we will and respond a sequelae. with these The to superior all by letter. believe we safety also and risks and blinded later. Kwan with the safety committed decision. additional with endpoint from to a trial Dr. in to and results are recommends assessment expressed We actively submit The the independent I options surprised X recap concerns of will the complete details quick trial FDA response raised Dr. The to in The team of asset. letter conducted new in working analyze give Athenex Phase

its We request as a to FDA soon the possible. meeting concerns discuss will as with

represents path on development to a colleagues, required for complete in metastatic but Oral also obtain patients disappointing to During cancer The we align of letter with breast patients. Paclitaxel meeting, not facilitate hope help us, approval. the response and FDA the for who outcome, only the clinicians forward our

are internal we working As accordingly. a adjustments and company, to appropriate the identify organizational undertake

clarity for FDA Oral late gain success the with outcome approval more Despite the Paclitaxel for to with able communicate FDA. be about our adjustment team Oral on forward the will year. from Klisyri path last the this achieved We once we Paclitaxel, regulatory disappointing

physicians United scar. has in face actinic already of innovation this States partner, compelling launch with mid-February, daily The Phase scalp of unique Let of most Klisyri patients Klisyri. trials as New the States the X with safety and option only as favorable clinical or keratosis the serve England that approval the of the product Klisyri second positions in a side me an actinic topical in Journal physicians. a of reinforced The application as demonstrated Klisyri benefit short profile launched requires foundation Phase you our treatment both FDA efficacy protocol for provide of profile. provides novel for common results face The patients. X can by actinic been and Klisyri with possible of once days. of for and dermatologists has treatment is been update. United Emerald. or Klisyri demonstrated with two clinical These for further indicated microtubule efficacy two of keratosis, and keratosis treatment the our is States. treatment the the our In of significance the approved Medicine a condition profile the option Klisyri published raises the and data for publication product the and treatment United The for new best-in-class compelling In that topical, inhibitor X as a trials, Klisyri the new awareness

reinforce force Almirall. Almirall authorization the effort. launch, to is attractive economics company’s currently also the application intends the European marketing sales marketing of to its partnership A review under Medicines terms maintains around U.S. Athenex force support Agency. with In by sales

in up already in indications. additional $XX $XX Klisyri the receive addition and Athenex to In expansion additional payments milestone eligible million the to additional received, into upfront associated payments million aggregate launch an milestone with and is to

regulatory Klisyri. receive additional company starting to XX% success In payments payments sales sales. milestone the eligible to is eligible is of for we annual net Additionally, and at similar royalty receive conclusion, had

to For this remains the around Paclitaxel, also focused Oral safety Athenex not only Oral our and program. Paclitaxel. but Oral reiterate on unlocking profile superior efficacy of I value maximum [indiscernible] belief in want Paclitaxel,

the focused bringing are Rudolf? patients to We to cancer breast market. committed and are this agent on

Rudolf Kwan

in approve that present This a announced Paclitaxel. agency you, its application letter issued response the the for complete the Oral response Thank The Johnson. that FDA letter morning, we form. complete stated cannot

of letter. The this are are the and disappointed agency We details complete main response two expressed with extremely surprised analyzing concerns. this outcome and

The non-pharmacological hepatic especially a despite reported death effect that was particularly with FDA It an impairment, the the patients is survival increase which the myelotoxicity-related concerned paclitaxel, first with neutropenia-related around is sequelae. paclitaxel in is risk the benefit that early neutropenia overall on had the of concern represents believe safety associated in We in label. well-established in we trend study.

on week revolves process and objective may Independent The concern stated FDA by of by agency second Central conducted have ORR, the primary Blinded Review, inference BICR. XX, unmeasured bias expressed endpoint BICR. results of rate, the reread BICR uncertainty the around at reconciliation response or The the that the over and

X to The of the primary which were sponsor, no process BICR completely trial endpoint hope issued. Athenex a that industry-recognized did We FDA. an the independent Form process when within informed clarity standard a were as the All the and totally BICR imaging Our sites, gold lab ORR. is clinical were pre-specified with concern trials blinded the followed. we XXXs FDA of use procedures and Phase for the on we conducting and gain BICR meet the

we requests involve further a a are in to patient in NDA. strategies approval Lastly, required Throughout dialogue of mitigation that a submit trial the in representative process, metastatic adequate of stated regarding the well-conducted cancer, optimization be with to improve and/or and The United clinical population new agency the FDA toxicity with may agency toxicity, the population which States. results of exclusion to support additional review of the engaged at breast the that our from patients risk risk potential deemed package. robust dose high we

of made information agency to request We review, the information questions. during FDA As the clinical with and any data process. the raised significant questions a address amount agency’s and provided

During hepatic the impairment excess for suggested the population early and one dose due myelotoxicity. accept proposal. without this agency exchanges, company the of limiting did would these potentially routine patients the mortality to of in not The label even avoid

as soon We to letter pathway will request company FDA forward approval. with the obtain response discuss align and a possible the to meeting on the to as

efficacy and We Phase in for strong in coupled Paclitaxel to higher Oral patients. a delivery, strong as oral meaningful survival, be with trend could The response trial. breast treatment conviction cancer rate, overall the Oral associated safety continue profile superior Paclitaxel and neuropathy lower suggests demonstrated have our X with in alternative

maximum call Oral our will program. but to I turn Paclitaxel, entire discovery also are over value only to the Jeff. creating around not We now oral committed

Jeff Yordon

Thank supply is of launch responsible and you, infrastructure supply The Rudolf. and I chain our shape. with Klisyri will update existing Athenex the on for provide current developments the manufacturing business. for Klisyri. our commercial an in chain is excellent

the forecast. facility high York as Furthermore, much launch Almirall, exceed to the integrated weeks schedule and needed our New shipped X The our are Our successful launch. of facility Almirall for ahead inventory business far supply model. Clarence underscores as current a able to positioned performance quantities efficiency will we of and current of

The products. to approval allow allow have year, from substantially facility manufacturing the of products. materials API new the API business. manufacture. unit begin at Currently, And in The a government We manufacturing our of us half our received Chongqing. to manufacture facility capacity revenue. to our manufacturing larger every of we and us more ultimately new raw to capacity The complete. we second is portfolio dedicate of serve in New recently double facility products proprietary will to this to Chinese to the Beginning than facility in will of commercial those clearly, can increase will from facility expect nearly pharmaceutical a increased these Dunkirk, our capacity to specialty XXXX. segments and of portion the our of goal for is Construction revenues XXXB business our our increase York these we generate we our plan sell the in needs

business year-over-year. million and performed positive last in $XXX.X and XXXX effects in sales, performance a as product recorded up pandemic COVID-XX negative result, pharma specialty XX% Our in year. both we The drove well

in to piperacillin/tazobactam included surgeries down markets to for and XX contributors Solution The products, patients hospitalized elective treat currently biggest with XX demand While the such as SKUs. used X and Pharma azithromycin, division sales growth levothyroxine. SKUs markets dexmedetomidine, XX and Athenex COVID-XX drugs are products XXXX specific Pharmaceutical products increased. Athenex significantly,

room We have just to products temperature will we new and continue stable recently in launched XXXX. launch the

have detail. add to our now We XX I Randoll our portfolio, to over more to turn over discuss call potentially margin which we products. identified the will in can that of financials products are high many

Randoll Sze

in items year a full Thank financial fourth highlight quarter key few you, I XXXX. the for Jeff. and will

more published the sales please earnings XX% a fourth $XX.X For from Revenues release were increase. refer million, earlier year-over-year quarter press morning. this details, to product in the

to the the sales were launch growth For drugs in year of and was demand increased attributable full Quarter year-over-year. COVID-XX-related million, and specialty for by $XXX.X product API growth increase partially is Product driven XXXB in decreases products. significant offset product products. increase sales, sales XXXX, sales additional a XX% by

up year-over-year. were plants. primarily associated in preparation gone with have expense our costs workforce and expenses the Increases SG&A possible On increasing commercial Paclitaxel side, approval SG&A the expansion due manufacturing to expenses Oral of at

in Xiangxue. the XXXX Net respectively. recognized fourth year of $X.XX credit provision with is to In to loss attributable we $XX.X in due to quarter license addition, were provision with XXXX, a of This quarter share, from $XX $X.X partnership currency and third of and diluted we respectively, in expenses balance loss million, or an XXXX recorded for associated the the conversion. our outstanding $XXX.X potential connection which quarter million $X.XX and for and million million included full revenue related Xiangxue related the per fourth Athenex

$X.XX quarter $X.X loss was to net the diluted for credit share. per million, the provision or Excluding loss of $XX.X million, attributable Athenex

of Excluding million to diluted full $X.X Athenex and share. net one-time loss for expenses XXXX attributable million $X.XX year provision, loss extinguishment the $XXX credit or million per was a debt $XX.X

and and million of restricted XXXX, cash December $XXX.X of of XX, cash million. short-term $XX.X Athenex equivalents had As investments cash,

sales available. terms become only from a limiting proprietary products a which In we of data financial until excludes guidance, result of portfolio, In meaningful for customers existing product recorded XXXX, we international global to guidance pandemic. significant are amount sales the product any as the revenues such Klisyri of

sales we or turn not achieved and we in We that subject preservation due XXXX, in I extended. XX, XXXX be further continuing believe of cash, Johnson. to we the second will into based plan, revenues what sales cash us us additional Based industry of guidance XXXX. Please expand nature excluding have will recurring our quarter cash our that as restricted call are cash portfolio. on have XXXX. any December expect November. in like investments with operating are expect cash the on note reasonably our do known equivalents, notable conditions Klisyri, reiterate will runway our We and I run-rate to provided as product product cash from structure to to back changes now our line been currently However, get in our to conditions. with in these in measures, would estimates see macroeconomic to current get change and to we

Johnson Lau

will for Randoll. you, questions. the now Thank I open call

Operator

Thank Instructions] Raffat with proceed Umer first of the line ISI. [Operator from you. Please Our question with comes your Evercore question.

Umer Raffat

exclusionary so have language either no was not letter, not much on questions. hepatic are talked impairment metrics think complete taking using. as trending have it guys the about bias, almost could there thanks you for feels for in presumably, the Johnson, what It the favor. side, response at has irrespective rate or issues Hi, our of inferior response least OS like about from been I if

without to Therapeutics patients, this. Johnson new have you could a – in especially for more lot perhaps And like? seen if either what we have travel the you or finally, interim resubmit So Why number but you assessment with a stringent ‘XX? a data, guess and at time, did and single-arm parallel some of like COVID one, FDA trial of And rates first this I it by again you may and patients, if KEYNOTE question in were resources response the half any look if context I patients? of with XXX or finally, XXG my United challenges can’t guys curious that Thank is try you. thrown secondly, XXX data that start

Johnson Lau

address you do clinical want questions? to these Rudolf, you. Thank

Rudolf Kwan

you for the thank Umer, questions.

have a on that. of You number components quite

did So I please answer all not repeat okay. some those of if of those,

the So, and – regarding that impairment, FDA question with that already the did not the excluding hepatic the make patients accept proposal we FDA proposal. to

survival XX% – Regarding survival, you the overall on response around rate Antonio update San the on in in as know, based we presented overall December.

those follow-up patients. We to continue

whether will more mature. is merit for meeting a any request further that a in the providing point as has the there at FDA even good So, data that with to we planned upcoming become raise the when update is

So, missed? what can other you remind I me have may questions

Umer Raffat

I was which can’t like half by have data why used resources if you just new a filing XXG without be run curious, KEYNOTE just first you data and could interim could ‘XX, trial going towards and also more resubmit it? and/or at

Rudolf Kwan

– complete depend study. on first the They what will will their clearly require letter. the think in will FDA a address I question response want

So on We in that for will discussion elaborate making got a clarity a the we will that and subject is following once we certainly meeting. go want to suggestion.

unreasonable one. proposal your an So, not is

We will into take that consideration.

certainly, view. more additional earlier resubmitting we data overall I maybe on just analysis new – a resubmitting is well. consider the would I than meeting at reinforcing question? mentioned venue your Regarding new as that as discuss answer survival in that the without data, this without convincing we perhaps argument my rather will as Does

Umer Raffat

very you Thank much.

Johnson Lau

leaders, areas a our that fourth we line were therapies be there lot we our clean that being to some highlighting clinical tested analysis that our other at and in studies perform a terms not more many should to to clarify creating more key opinion overall geographic discussions in they applied compared survival with analysis. studies for that the having geographic our that confusions to to patients overall measure like regard the clinical them conducted when the the was of are in that Just comment lot be will our of studies of are time our therapies in be survival because were bit the a more that reflective, we you, further be with areas will Umer, interventional actually

will and – and certainly in we response was So, that opinions our the we meeting. a all these our very important during felt our FDA to point U.S. include that,

Umer Raffat

Thank you.

Johnson Lau

Thank Umer. you,

Operator

Thank you.

your of Our with next SVB with question question. line comes Leerink. Jonathan Chang from the Please proceed

Jonathan Chang

Hi, questions. for my guys. Thanks taking

the does with comprise guess What does what of? can future this FDA suggesting I specifically the have a question, color population? new you besides First what the study? the this and geographic is representative provide in around U.S. issue implications patients comments locations U.S. regulatory of potential in taking more a study

Johnson Lau

Rudolf?

Rudolf Kwan

They U.S. all representative of the population, about for that terms point. U.S. patient that interpretation we a the that discussion a additional geographic obviously mention perspective, did Yes, the the mean receptors whether thank The as you they representation certainly we concerns interaction what not want very a done is specific in they be to with can FDA. issue the see have types with the location the the and of reference of FDA. a of population to clarify our geographic of along population location From were centers subject none to U.S. would question. presentation will that the in

So, or in the clarify required meeting. in done be the not, with U.S. we whether it whole the to to have them will study

Jonathan Chang

seems in multiple should thinking Got about I Any each color concerns order press FDA’s like it’s how And second the of but reverse it. it’s if over the the question, help can’t of here wonder the would cites CRL these issues? how of be it issues Thank here release? in relative we you. the helpful? waiting listed be

Rudolf Kwan

I because as not on IV sensitive. It’s in myelotoxicity of its Bear labeling from Paclitaxel. to two the known in interesting documented issue clear hear each are of myelotoxicity. a think of the that the well patients mind, the late own IV pharmacological hepatic risk impaired agency, is also we is rather would of effect effect paclitaxel, it an the cut those like as observation, issues more

those handle it’s available are pharmacological genuinely nowadays. knowing the and G-CSF available, So, a it effect more having in that and clinicians not surprising can things [indiscernible]

the they concern. impaired did address that patients not their would on a And so certainly, by us accept limiting hepatic that it’s the to labeling surprise that

complex. having aspect, all – and even that hear process, us review independent to that the standard, readers the for the cannot articulate them, all and all about We of witnessed are study and to lab in bias they feels blinded this industry the conduct and And sites having that process center the The it’s are independent our radiological independent unmeasured which clearly. totally totally, they the other still clinical process, concerned the process, having concern put especially blinded use issue is completely and more that blinded this are is process including frustrating conducting well-documented. are bioimaging they

agency the the So, clearly, the and of inspection clarify total we process read. after independency the of with have rigorous to a bias constitute what unmeasured

we try agency their view certainly will the discussion on explanation an So, them. with to get from during on that our

Jonathan Chang

Yes.

Rudolf Kwan

about the Okay, trial.

I discussed third be trial really as trial. the item, an they as the think item the with trial would is, and the third is well what them will conducted indicated, and see adequate

Johnson Lau

provide you addition me let in color and Dr. Jonathan, to some comment. Kwan’s some data

there the brought they So some myelotoxicity. were the effect neutropenia-related terms the study, the in-partner was point that in early that up first of in sequelae

So here in information, for roughly for within the ORR were first of actually just terms X% Oral around very weeks trial, of Paclitaxel we the Paclitaxel rate similar, IV the for first your rates death the X% the and the have response XX of mortality.

I in intravenous So, the higher Paclitaxel. it, benefit neutropenia XX ways in mortality, of the little for I difference to bit myotoxicity-related was or I basically, there – fact, and two patients. mean weeks overall a also at side look effect that the there much impact, not are think the terms first for mean to due

already of Antonio Now in a we for presented that Grade Paclitaxel Paclitaxel for X you difference the X was was meetings, X.X%. our neutropenia and IV about in San and to remind presentation so Oral XX.X%, the XX% neutropenia,

then single a the in assessment Certainly, with need points related increase So, information a same to other FDA we and benefits are ratio. the guess substantial and for should risk neuropathy considered At of analysis, to to rate with these it’s look we of the appropriate. for overall we risk-benefit benefit these response to significant want highly the and terms the of risk bring survival obviously involved also or in time, I the share also ratio discussion are the be the going you. every reduced sorts in

Jonathan Chang

it. Thanks Got taking for my questions.

Johnson Lau

Jonathan. you, Thank

Operator

you. Thank

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

Kennen MacKay

expensive. that Hi. here. Couple trial has first to of another requested how and maximize would you value like the questions it It shareholder of could to plan understand randomized just sort FDA clinical from Johnson, here? seems be is foremost, love prohibitively

or Oraxol in So feedback continued options what would other wondering, other pursue and or beyond would And the the strategic debt? think more one, CRL? certainly Klisyri remaining subsequent I funding then on question be there potentially generics a business have in manufacturing interest to are geographies? I just FDA value development your

Johnson Lau

off, talk very consider any their discuss control then believe the very, recommendation. they ones seek Hopefully, more that is go of side – Certainly, first believe in good benefit and of view are neutropenia Certainly, not effect word terms in regard they it’s data. in already, then the with we ahead did will [indiscernible]. the expectations, also actually but changing the because their within a to try feedback. study more with have will believe I nature regard to or sufficient their we – and We We of provide the and the to have presenting specify we study the with mean, data be to cytotoxic that is all we we did are data necrosis they use we will then not our data. based recent FDA, going

be their So, satisfaction. study of showing will of of at set direction, provide same to like discussed. data be former remains by the them nature, smaller type but to certain This a will to the we able parallel by same time, demand sort would question study terms recommended a directions what that to be to seek FDA showing needed to whether with as of feedback regard aside their a in

we it. small a be – in and study, be position support also our the are we But the to of we’ll in time the as landscape if position big study, have will programs the big to how decision. study, as if to we a can other certainly, compassionate. Now a a reconsider a it’s competing financial involved before We’ll implications, make regard compressive well firm nature the it’s with

long So sort can some I’m of consider, forward. FDA after push regard have analysis program I clarity to giving there a the to but answer, in particular, the response before with many our this are to we you factors from how apologize,

Kennen MacKay

that’s And to me, that the then is segue and Sure. feedback maybe huge to in that of interactions a a it some seems question. second my like priority your theirs It review. was given prior even certainly CRL, FDA surprise granting that shortened

care, Johnson positive maybe communications literally on your for the reconcile And Athenex So, granting lack Rudolf, And press Meeting, patient wires? on how X gosh, received somewhere Advisory and you of it release very prior this U.S. as mixed the you prestigious positive CRL Committee priority XXXX or well that apparently requesting Phase of cross this review the do a ODAC. FDA design trial standard your messaging seems reactions U.S. an and like and FDA trial I also clinical With FDA population design? titled, representative Paclitaxel. an feedback with as from or a of trial mean,

Johnson Lau

Rudolf, to do you. this want you Thank question? address

Rudolf Kwan

Absolutely.

– the the from study received and and about the the because U.S. not really comparator all benefit the have the discussed that submission. clearly design package, arm that as by documentation in is we that written study conducted clearly And fact submit the include we as have when NDA considering is FDA proposed talking think they the the risk the seen single the positive sufficient, with information that them shown one of confirming with the second we the FDA results in I we certainly, should the data. be are and

the we the in standard submission of to neutropenia their those the Antonio for were in data, XX waited us And all the analysis review. submission in data announce gave and that package. we all priority safety present So San survival acceptance days

So, cannot there very positive. a were all way, explain are along certainly, And the those. lot of those I

minimize For scenario the proposal is lab, in change say result the can results. that one into of offer central And favors what there known, we those if a is. were example, up there, worst-case the is were golden number standard minimal our and a which also that change don’t the that extent it and a you myelotoxicity in come industry. to we well the Athenex that you And hang risk And take only on two up them we more. if a We incorporate certain even actually that. to up documented, that know

we know don’t hang So the what is. up

We change. really confused completely are this by

So clarify forward. with the agency that going we will

for more I suspicion the is think I perhaps they suspect their reading point. in purely the this on are letter population data. are U.S. focusing at that my purely that speculation time letter looking some U.S. That’s my

Kennen MacKay

obviously some follow-up be review of Rudolf, overall that, data, of it blinded And survival on concern looking of one bias the around like some which or bias in biased. at be introduction seems the there could the mitigated by just

neutropenia. that, overall obviously, some the on that factors survival perspective And growth prevent on just secondary U.S. population, to to more FDA’s about wondering much use of point, then data? G-CSF Just the thinking to your of

what prior in building off trial, that you’ve you this limit the U.S., tox some could it’s at to that protocol again, seen GI were If about the of like double the of adverse of these to add Phase we’ve thinking or trial, of you from arm experience half the single and gained we events kind least arm, whether the in that neutropenia X? the first running saw a things some even

Rudolf Kwan

obviously, myelotoxicity have U.S., the more we which certainly, the example, I-SPY seen population, encountered And angiosarcoma in of stage the ongoing have as speak. more the patient very the in similar we we Yes. X; practice, we as This haven’t the studies – program, U.S. experience – and with interesting. for the even U.S. study. in the is early level in way example, The for we are collecting of

U.S. U.S. population the handle may better. perhaps a clinician can how handle this So the us give

this stage. is early Now

population. same are XXs, I’ll feeling signal. with they the they regimen So XXs, hear more about certainly be good certainly it, in But become that the and the more about but and we cautious data about multiple those drugs. certainly, patient are safety we I-SPY And – a in they co-administered angiosarcoma expect elderly being watch certainly, you mature. population, other are XXs, much in the the X where XXs used dosing In the to

worrying see seen. data do certainly that we’ve not we a in So XX signal those such

way continue and U.S. we’ll whether that So by that question? follow of can that can that be they what on more collecting to the propose answer information we Does that mean the your population. understand part up

Kennen MacKay

up, one population. had an potentially market And could for final market, and cancer This indication maybe faster a – in breast huge now. to need area much small even segues angiosarcoma does. than that’s accelerated the It to huge see a a question is and that brought something path off obviously more path well, you unmet

Just approached path you could have in that? to market FDA how that if population on or a the you potentially wondering about go

Rudolf Kwan

destination orphan the FDA. obtained already very that completing We the from we And study. drug actively are

no are dramatic in earlier extremely completed of encouraging, patient our study. reports, And very a enrollment in enrollment, certainly, results we previously rare convincing approved pictures other San and as conferences. in were where it’s are of as the think about you’ve and And either Antonio with by I medical area seen an evidenced single-arm to there disease. really responses complete is the some and pretty standard XX treatment

formal the venue and request them. to would disease than indication. react be the to this a We So that to to to for FDA [indiscernible] that may FDA forward rare be meeting also how will the our collected interesting differently present mind, but is disease, a rare agency. intend treated discuss data be within the an with could see in Bear this path

the test. be of So we that will regulatory certainly consultation aggressively progressing

Kennen MacKay

you. Thank Alright.

Johnson Lau

Kennen. you, Thank

Operator

next comes question Karnauskas with [Operator your from proceed question. you. Robyn Truist the with Instructions] Securities. of Please Our line Thank

Robyn Karnauskas

can the Hi, scenario. have a because the So just we patent expiration question more bigger guess, have I just scenario? you that take other XXXX. cast guys. center you you’re on how a as for this to explore best would do best a Like in it is trials, or possibility, Thank then second, actually where study ask you. long like in through if do If an you’re you case scenario the would for you? is And study more product? to forced that is like much they explore case still a estimate worst-case controlled worst-case a under saying there

to proposals So going can to you when the I have documentation FDA you for next? to walk the get and together some us lines you’re time think through speak together.

on So it best till the and going Just how the then and worst outcome, have to you you’re Thanks. time lines? example, some Street, bookends case case, would like, and compare have to meeting time and some might the minute? request take us wait ask time the meeting like help for you with to

Johnson Lau

Thank you, Robyn.

to regards neutropenia-related two I think question, FDA concerns the first with terms sequelae. in based the of the later on from

will it a we this lot data be fact would with mechanism-based side regard how can certainly believe some is have make concern are to we I a is the to that do we design. long how effect it be the think more is that that required particular case and resources And there will the their the paid to handle study with address concern concern. able manageable. whether take and this a Besides

process concern with with controlled done the already present to Blinded and with also review, blinded all our well process entire the Central Now Source in that was regard a Independent the and document. of [indiscernible] the information together we

re-read they concern on and other one that, And any the COVID it mentioned take process reconciliation It – and that our into have did better. actually or not the one patients process. even data data related unmeasured by As some bias. X look consideration have the change only makes actually if you the process was Dr. in actually, Kwan,

Obviously, We of back So is concern, the may process process. different of independency our our in going once of the opinion with have to try present how best is data. and regard therefore, terms they the they we’ll some think data. may the understand feel the I that quality I got – independent a the – we integrity there that to mean,

such soon the is on I’m a study. for try data we’ll can range. FDA to question So to regard direction, provide looking study, to And we obviously, as our small your as sure of possible. Then quite this that it be best a with just

The already are other aspects addressed.

FDA be process review the by may exercised. therefore, So

– possible. of obviously, for hopefully days. as is line us to soon Dr. package run will time couple meeting as time a FDA to the a within prepare need that regard Kwan trying as possible, at A followed we a and our for to request we submission the be and a then to line. the time package usual Type have working FDA to soon hope ask meeting, meeting expecting And weeks very and a But within XX we occurring by we Now with submit then hard, as FDA. sincerely will line the are before And

would into of submit with some FDA think looking weeks meeting. have very we want time to will line the we’re I soon. So a the clarity that together the And couple

Robyn Karnauskas

is one on with question. trial in they mean, the before any refused initially may. of it with what filing seen are – FDA people KOL usually, you on regarding changes XXXX, once either experts, the and Did where changes? And like sure if more they file you of the the the points filings, a like people side. integrity any question acceptance think, we’ve data get data the And of advise with times interacting you’re who surprise you there Are follow-up a it’s recently of Because this I situation? saying between I lot the spoke people I’m to I have seems – with advisers approval have about that been because today? ICR space are this, like, happen there any the you the in

some really there color for be helpful us? maybe would So just

Johnson Lau

Right.

it upside we FDA, X was comment with on protocol. have And a correctly, if I of a product. expect recall, be us Phase endpoint protocol saying the and to the that more we us conversation I to if a letter what to regard with in send nice FDA as early on vis-à-vis when that ago January the we I far have standard late said they a submitted think submit for X the As ratio, approving for of remember other that because have FDA surprise years the risk than was by we benefit primary was very the aspects is a the and to the or information that the followed if set adequate And we to demonstrate letter with we the received, it followed. other requirements design two-sentences simple to regard consider protocol meet

So the based the letter. the that information basis received available letter of we was the that that we received the in on press release and

mean, meeting, that mean regard address then there – letter stage by effort. the that regard subsequent to I change there – a whether developments the resubmission discussion. Dr. question followed Kwan followed with I mean, I names the not with there will to then is again, let number the from – many be Now attached in be regard with leading But in Kwan and process? with I’ll is to Dr. since by to recently the personnel the Dr. Kwan? of early

Rudolf Kwan

Certainly.

I a with the the we to change type the the everything think pre-submission XXXX meeting along is submission to essentially I in whether group that way. cannot to say the similar, any cannot remember the meeting there think answer. had SAP were it should the be discuss C from don’t and we process I fair FDA personnel

Robyn Karnauskas

you. thank Okay,

Johnson Lau

Robyn. you, Thank

Operator

Thank you.

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

Kevin DeGeeter

Rudolf, guys. or material as for profile Paclitaxel. share consideration was the comment Oral neuropathy differentiation, my was patients? risk there’s Hey, for the Thanks just taking profile light of benefit FDA whether for that at in least areas the could work viewed questions. a you in our by Any

Rudolf Kwan

is neuropathy the review. follow-on that we Antonio show Kevin, witnessed have despite have view I continuing where they the understand also probably think, the it seen as differentiate clearly submission, XXXX, you the have I my profile probably then would way and in the in you San interpretation benefit taxane what area still – we another be when differentiating. a – the and update I we is approach And to such sing efficacy would neuropathy see when the neuropathy. as we of a in that study. parity drives think They the make in can the And in neutropenia see

all by have been factor, we with. has So which differentiating that’s echoed KOLs truly the intriguing talked

So discussion would your they a But ever certainly, whether question been assigned they in along when raised review. have acknowledge? since. is assume way the has I not FDA would the that a priority knowledge the

certainly proper KOLs be view that can more believe clinician discuss the benefit to with would it’s a with perhaps, do raise intend the we So should we risk U.S., how the assessment, something one FDA we that And side. in from when provide evidence.

for So the thank you asking questions.

Kevin DeGeeter

my largely at question, you data building not ideal least in the comments And a other is U.S.? it to regulators take suggest other would modes different for in seems And are as well, follow-up analysis strong to of from different for my that, a view regulators the And patients CRL, my there care outside in other engagement to jurisdictions remind have jurisdictions recognize be seem well? to a jurisdictions. this the jurisdictions. that be delivery Great. risk-benefit Can in with regulatory to But question. as on regard U.S. that to us as strategy colleagues well, I

Rudolf Kwan

we actively be will what are exploring. Those Absolutely.

certainly the Within the and exploring we MHRA. were company, EMA the

European recently by the Brexit. is, UK way, MHRA the So that’s Union leave following the is

before. partner other in we active Asia are to partner have had will we we’ll that agency, we venues essentially and area, negotiating our Taiwan, to actively partners interaction FDA, an interact an with Oraxol pursuing. have our And start our the in in and previously, – And where we the on with that. the are health China, New Australian those China. the So certainly continue expecting we have explore IND And be also Zealand China

pursuing, our the health Bear and venues potentially were health to system use the authority actually the may So see response certainly benefit of is additional may that add mind, drug that there different oral present the we care have case profile to the an will in those whether significant interpretation. of FDA of the system. ideal we are for is care where the be to of benefit countries taxane health

So actively those options. we will explore

Kevin DeGeeter

Got you. it. Thank

Operator

you. Thank

& question your Jen next comes Our Company. with Please question. from Laidlaw Yale proceed line the with of

Yale Jen

from you that will that issue the question slightly to for much is that they of account about the consider first me, on want my be is the of studied, decade given which taking they a the us? Ukraine, completely sort than than and Abraxane, that that population approved set – the need although a questions. a U.S. population versus FDA data think will that mainly more the in will U.S. is and and with and Excuse have for based Russia was for two-third the thanks more data Good larger something ago, morning that’s more the

Johnson Lau

Rudolf?

Rudolf Kwan

Yes. I will clearly them. with discuss

the they the not U.S. is word population, I in of way it, I U.S. it, conducted read as think represented

like? in it boils our I maybe with they of they meeting do the study for it proposal probably operation. is mean answer would once with what down have if a certainly, And and U.S.-based in not topic But that all the the discussion. representation the better FDA. So them, by really is acceptable would certainly that we allows entirely terms what is that Now more flexibility that a that clarity

Yale Jen

FDA helpful. has one And be there not it’s clear suggest that recognize very may standard. That’s is follow-up certainly, we go And introduced. more that certainly Okay. is Review question the Blinder here that why

of in agency, So would better seen able to sense specifics future the have ask be what more with they being what mean? potential will they your a introduced, you you so-called the really meetings so have

Rudolf Kwan

up probably And with if are the essential that vaccine study. following when is to especially completely this the that are independent in an And procedures readers I right, is this they not independent will trained. practice adjudicate. whole clinical don’t essential of scans straight. fully to their the independent they a refer versus some are FDA today and case, weak certain, state the art, were very correlate. When always search, even And because process the use or the completely mind blind to blinded then use within fully with central they training trainer has – the not are two the radiograph In mind, lab They reader that the maybe very that’s initiated. We interesting third already in. dialogue they would we reading anticipate way, would Absolutely. in whereas and correlate, trained days, investigators lab, at themselves, look

processes those really are the of all art. So, state

time. to they unmeasurable one look the central of have I from will with because didn’t the And this be want have a obviously, we at will we out we probably analyze would bring away case, taken done. I central individuals collaborate scans those the they assign move bias probably in in FDA, the that would So certainly And something themselves whether X-day days, an can their have struggle the explore Those scan. find time, don’t with and question how lab will is to old they know how to with the can want additional FDA, them. – task do raise or to and topics

Yale Jen

I answering and will great thanks for question. Okay, move forward. the

Johnson Lau

you. Thank

Operator

Thank you.

question. from proceed your with Matt Ladenburg Please with of comes Thalmann. Kaplan question next Our the line

Unidentified Analyst

is for in This Hi. Matt. Raymond

you Just a dose on and quick could that agency optimization provide was language whether additional I the the question wondering any provided? follow-up, color more one

Johnson Lau

No.

Rudolf Kwan

No. Certainly not.

question about as with did a adjustments – should we protocol. – in think laboring the think patients there those impairment? That’s discuss to how did for discuss the then was those what dosing, be did we early agency language we we in propose did. when I made the with the talk about I use it hepatic stage And we

we only was them. had that so And discussion with

of will just clarify risk what this those be presume kind Certainly with considered questions language. be want would for the of I best that group And them. dose we reading optimization so higher follow-on a to

Unidentified Analyst

follow-up the is, on provide in perhaps impact is general just an some that? to due pipeline maybe just the FDA, on the from cool. color there language perhaps a And Okay, additional

Johnson Lau

your assessment. their I on none them are the second think center to Let the of tied answer was the that The were side that independent working blinded question. effects. are question asked, the sure appropriate technology right platform or architectural really on now. events specific to such review that adverse we according mainly And making questions was was And two me one one on

other mean, assessment, and and for programs. But into we we to have there when the that on and both this and I pursue to this regard tie something So – platform is is the there, with is how the therefore, I sufficient data clinicians. for a we’re we impact sure to based mean, restored image platform, that should not going certainly, make work to to ensure regulatory the agencies confidence through obviously, patients investors for provide be

Unidentified Analyst

Okay, thank you.

Johnson Lau

you. Thank

Operator

Lau to turn and this you. the our for Thank session. gentlemen, final Dr. question-and-answer any I’ll comments. concludes back Ladies floor

Johnson Lau

Thank you.

launch on had a response and the last approval the Paclitaxel. FDA X Oral the received have complete During months, from Klisyri letter and we of

And time, the towards information undertake Our with more the to is Paclitaxel morning. information on the the regarding are you your internal we’ll and path call Oral will time us organizational the working the concerns to forward team FDA working information this same for appropriate continue identify At communicate address NDA available. a accordingly. when Thank in this we adjustments package. joining

Operator

Thank you. This concludes today’s conference.

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

We use cookies on this site to provide a more responsive and personalized service. Continuing to browse, clicking I Agree, or closing this banner indicates agreement. See our Cookie Policy for more information.