PBYI - Earnings call transcript Q3 2018 | Puma Biotechnology, Inc.

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Operator

Good afternoon. My name is Diego and I will be your conference call operator today. At this time, all participants are in a listen-only mode. After the speakers' formal remarks, there will be a question-and-answer session.

As a reminder, this call is being recorded. to Director conference Biotechnology. of like Mariann over now Senior Ohanesian, IR would turn call the to I for Puma

may conference. begin You your

Mariann Ohanesian

conference financial Diego. to quarter you, Good and to Thank afternoon of XXXX. discuss for results Puma's our the third welcome call

Chairman the release, Chief and Puma Commercial refer of Charles our XX the me sections Officer; slides Officer, on days. and Auerbach, archived on Finance of Executive Puma; the webcast news next release detailing The financial our that available slides news accessible XXXX SVP After page a today, will be today for home the and issued call Joining Board market pumabiotechnology.com. and Alan of Steve presentation of to, and are Chief via and quarter President website are the call of Lo, will close That Treasurer. Steve Eyler, our website a third for Investors replay and at this webcast results.

I out federal Before operations, other to the forward-looking of over like within an All for laws. and are conference would I performance based Alan point of assumptions. statements to our our than are current during we overview historical on will and this meaning call, statements make the statements facts forward-looking securities that turn call and expectations, forecasts

file December in SEC. and and are expressed could the Annual subsequent actual uncertainties ended XX, to results our on expectations from forward-looking risks that the anticipated we our any and XX-K cause Report statements uncertainties results risks XXXX, for in documents Forward-looking involve differ materially statements. year with identified the Form and these These

of call, as company to circumstances not only undue this no this statements statements conference which date The obligation cautioned after call, revise required XXXX. forward-looking November reflect except as these reliance undertakes law. any events are update forward-looking the on date place of conference live of to or speak X, to the by You or

call, figures. we a supplement refer not certain may investors Please non-GAAP may non-GAAP our turn release I that to to believe refer GAAP quarter financial non-GAAP We to of today's measures. metrics measures to Alan. a a useful During news our these third results. over XXXX as for GAAP but involve adjustments and to the reconciliation will substitute for to GAAP call our financial our now be

Alan H. Auerbach

Thank all Mariann, for today. our you and thank joining call you,

known Food by continued XXXX since We drug, are to with and as sales States treatment approved pleased grow million cancer of reported $XX.X also been a of the breast who Administration net have Puma's the to we United Drug in report early-stage approved sales patients XXXX, was trastuzumab-containing reported NERLYNX have that $XX.X an million first the July quarter of NERLYNX, neratinib, XXXX. launch. in regimen. increase NERLYNX with from for treated second the the HERX-positive net quarter third previously Today, sales of of in for

to-date. turn payment detail the our revenue launch-related Chief one addition, will third the Officer, licensing NERLYNX included activities partners. will to in moment, Puma's a of In Lo, U.S. an quarter licensing In of our received update on Commercial call which million our from upfront represented and an commercial $XX I provide we over Steve progress results who

adjuvant authorization one less receptor from therapy. and patients with hormone stage than third the that the The quarter included Commission extended we In European of for for adjuvant are – HERX-positive treatment announced for XXXX NERLYNX completion who adult of year prior September, of the major marketing breast trastuzumab-based milestone a Puma. positive granting cancer early

second first Germany throughout half additional beginning with followed in European of Europe the by our launch be countries We during the to expect and Union NERLYNX commercially half the XXXX in in XXXX of available XXXX. in

acceptance Products included CANbridge our accepted National stage adjuvant also October, Medical The in of adult received patients China's its extended licensing we Pharmaceutical, our drug trastuzumab-based quarter partner, that And following of breast submission early Administration for HERX-positive with announced confirmation cancer, new treatment of XXXX in New that Canada. third Application adjuvant the Drug therapy.

for of countries HERX-positive extended XXXX. submitting anticipate NERLYNX also regulatory We the indication cancer approval in breast for early additional adjuvant during

also We neratinib. additional several forward look for to clinical milestones

III endpoint survival the As in overall known investors HERX-positive NALA have survival. and has ongoing breast trial trial. metastatic co-primary we an aware, The cancer, as of are neratinib progression-free third-line also Phase trial of a

endpoints. survival of have hit to required We analysis the overall do survival recently number full and free events the both progression a of

the anticipate top the overall in the should year. be and progression process survival trial survival endpoints or free from and able We this late the of both that next line early results announce we year either data cleaning are to including

As involves overall outcomes. of one four both results the and survival free sees co-primary the company endpoint progression having as survival, the

The and for overall first to the statistically company plan to If the would data filings. with regulatory occurs, potential outcome the regulatory would free for progression survival be endpoints. authorities survival if the sufficient trial meet are that significant both the this achieves determine then results

would the would and down trial in a to trial clinical this either trial rapidly to significant endpoint. free progression second that seek NALA any the statistically the outcome the with reduce result associated were survival survival trial. or If future The be does shut achieve occur, the expenditures overall not company

that to represent expenses trial have a on trial anticipated NALA impact profitability. near-term XXXX, path Puma's flows believes approximately cash company beneficial in the XX% As to of to this XX% clinical would and the is Puma's

blinded does situations progression overall In survival where and specifically depending and progression survival free and The company third would less the one or which four occur. survival top achieve data, line likely other the significance currently these free is may does is significance, survival a regulatory be statistical data achieves not company trend company where fourth either results. with of significance know will it update does filings. further these where and to achieves outcomes . outcomes the to on overall More to of investors does be The would if this meet to the statistical not has the in seen endpoints the not or but more choose trial not. The agencies statistical once the provide regulatory supports of the see does.

has in the the mutated major were continue was the Based approximately XXX meeting X% Cancer given was tumors Nature basket combination to pre-clinical the neratinib aware, arms greater neratinib patients were with these and the as every XX% from solid or In The results, publication of mutated AACR, neratinib trastuzumab was in cancers tumors. in of neratinib SUMMIT at based found XXXX. SUMMIT patients published meeting arms trial are that in the and initial on with addition, approximately treating HERX trastuzumab in The neratinib patients demonstrating plus the XXXX presented trial. tumor. monotherapy. This to to data referred in modified at trial an AACR in suggesting HERX in was on of treat almost Research data mutations the trial of other Puma is data involved as trial. ongoing investors Association HERX monotherapy some was American with to In as efficacy mutated HERX of XXXX, that which for presented of plus

and SUMMIT XXXX, approximately XXXX. has quarter October data trial of patients. additional the half XXXX SUMMIT anticipate fourth first the We Phase enrolled in XXX from reporting trial of As II of the

mutated meet XXXX FDA HERX tumor with and for clinical neratinib the in plans to goal indication neratinib the Puma the In addition, regulatory potential of the for discuss first discussing to agnostic tumors. development in quarter strategy of with a

We will continue to obtain update we more investors regard with information matter. as this to

followed over Steve Lo report additional quarter by call use NERLYNX. in and key of the XXXX. the who Steve to CONTROL diarrhea breast to-date discuss the statements turn XXXX. from highlight of quarter commercialization will prophylaxis will addition, who involving study data components will cancer expect patients II for Phase Charles of I our on will financial fourth In we Eyler progress early-stage for our HERX-positive antidiarrheal neratinib-associated of in to with now our U.S. third the strategy be

Steven Lo

have a States prescribed since been for over our market Since you, July approval year patients the NERLYNX of FDA Thank has of Alan. been in XXXX. then, thousands now United NERLYNX. in

providing and patients. to the quarter to to grow forward continued in more We third look NERLYNX

be to physicians. execution the reaching of patients on and more continued focused We

NERLYNX to network six then company, a of from as pharmacies pharmacies provide arrange home. to the to have making during specialty access, NERLYNX recall, specialty investigations, patients such, ship at obtain slide are our conduct patients. you and directed educating patient the insurance indicators NERLYNX, reminder keeping of On ensuring my progress primarily be performance number that more NERLYNX, As patients and I A key the benefit their will approval prior statements. forward-looking patients The directly on authorization on the our active with of X physicians. may presentation

systems X, This the prescription distribution FDA results, and sales ability health a We NERLNYX does from financial to of but you I Charles be to review not provide need full specialty to the also integrated care also specialty Later to current will have VA. net patients office, slide the quarterly the the pharmacy. On facilitate sales their since call, approval. will for in sent with helps directly obtain certain NERLYNX separate now you physician's the results. where channel see the

medication. being was our grew prescribed million This more and in of the As on to a the third revenue $XX.X product growth Alan mentioned, sales patients quarter. staying NERLYNX net result

the best Furthermore, patient's our currently program third XX number and the patient of we NERLYNX next and perform both month. by not of also was up of setting, However, patients. Also, that discontinuation many as may to do specialty we Please distributors. we patients. there the NERLYNX active specialty the in in number these may monthly will is is their who that estimate the have a there through from updated numbers X of data presentations. the NERLYNX the the their and Note update year will on receiving at differ also total ensure active month an for months. not pharmacies. specialty prior do to is adjuvant we note Therefore, quarter, of prior the were numbers increase pharmacies is total pharmacies net discontinued who completed quarter, there discontinuations. patients reach also through data of received patients of each which shows the final completed the I from the patients be This active includes lag And patients patients. therefore in a in each received audits had shown when We who patients to drug free further X% include days discuss numbers. aware the patients Slide extended slide. NERLYNX monthly in patients updated

due see patients and can monthly to continuing the NERLYNX continued to starting You patients NERLYNX. receive growth new

at patients as chart. end of active As October. each you a in month since the see of result, included the continues the approval FDA also have grow month to total number our of the I

XX, October pharmacies. active we are drug are patients, of Of we through NERLYNX. X,XXX X,XXX on patients these receiving As estimate specialty estimate the there XX%

We payer have between choice physician also noticed on based back channels and that go the patients forth do many two and mandate.

due NERLYNX XX% the in active their patients therapy. and The the As increase the has revenue contributed discontinuations mentioned, chart approximately quarter This patients last since is I NERLYNX increased since on number discontinued patients events adverse minus to of percent quarter patients net of the is discontinue in in completed who to past growth. of now lower who have patient the number the or launch.

with this, compliantly diarrhea increase to steps recent prophylaxis to surveyed educate are discontinuations. a when increase patient XX% the submit treatment information using prescribing our the reduction the to from X and this the CONTROL prophylaxis antidiarrheal physicians decreased in discontinuation the antidiarrheal believe we with additional our of CONTROL continue budesonide NERLYNX. be order using data data colestipol we when NERLYNX. have were antidiarrheal FDA that may we to potentially from research physicians that market address a In any so to medications, planning physician taking CONTROL the that patients data Also, regimens about treated the that the prophylactic in for of showed shows are with awareness trial not Grade added While in and NERLYNX. contributed most could We on from the early to XXXX, starting study to in

over the colestipol from in trial the discontinuation in arms Symposium Cancer the diarrhea now are data have launched we at of nearing with treatment. and staying In some we patients San the NERLYNX discontinuation X.X% were This the ago, As presented alone and have Antonio a who their rate who of beyond the year the CONTROL of months to respectively. Since trial patients their Breast XX XXXX, XX.X% this XX due in rate there arm extended the of a some trial. compared to in favorably that loperamide also one patients of the budesonide There XX.X% a discovered are started therapy months are who on year completed we have NERLYNX. year. who adjuvant patients are even ago, reminder, set

of small were of approximately eligible are for XX% While our XX at overall patients, patients this longer seeing is a that who we than percentage to taking XX months are NERLYNX still the months. end active

NERLYNX to X, throughout a each the time summer that to of or less, continuing less, in receive how to this growth are forward. choose we of during vacation. NERLYNX slide active metric payer The been patients the months. This XX XX a is we sign of days as you beyond starting reimbursement prevalent it this even in consistent NERLYNX NERLYNX XX% delay doctors that the frequently encouraged has will who NERLYNX. market. the coverage. receive which such patients saw tell There month and and been believe patients has reasons due in occur a see to to good bottom days While small is, see and process watch line more on patients a are supporting it We continue smooth On number is is travel in this and too this or personal most and and moving continuous we year continue to see we early patients

on the as off-label metastatic near situations have times we are for cancer ask insurance also who holidays, These longer promote. to right or slide. or is we this well. There to information. use the the we which HERX-amplified As for small of shown number prescribed monitoring side as patients HERX-mutated a NERLYNX typically company do such not the of will more The been market contribute fill,

on prescribers on slide Now to X.

the make to conferences We opportunities are continue to audience diarrhea the believe more them more reflected access here. third not are sales or quarter. is We online increasing progress reps, reaching through increasing in awareness reach management of physician have we in numbers there physicians reach which XX% to their and target opportunities medical especially still options. our in There physicians restricting to to more

launch in we As Alan Europe, mentioned, with our the of regulatory United approval States. for are preparing outside

building commercial our Canada. in Specifically, and operations we on are working Europe

reimbursed you Global been on The Europe are planning first and in the been and slide As health France, availability by in see are underway. already Europe, are Europe. reflect X, product have amended we the in made. has working and United Dossier has ensuring NERLYNX we Value to health will be indication progress technology the Germany, the country-specific been in countries Kingdom assessments for authorities

opportunity patients of we exploring outside Europe partnership commercial in already we parallel allow access approach, Europe also in place As NERLYNX States. a Canada. for In plan will on either Furthermore, we you for path, our recall, have a availability the in expect XXXX. in are program managed United and

we providing NERLYNX and physicians. are patients partnerships, world the of committed Speaking across to to

Australia, going established Israel, Latin and America are China, Our well. America partnerships South in

we and throughout progress encouraged We will as expect highly slide made you year. globally, be partnerships XXXX with timing our approvals Puma, summarize, next we see we've partners. royalties of each double-digit will payers significant To sales from and are and partners our regulatory for percent physicians, the the year of receiving patients. be key can a of potential in expected these with approvals with X,

to grow sales. net our We continue

medication. on and help continue receive We and prescribers to stay their patients more reach

turn to of over review NERLYNX. Eyler the Charles I a call results. patients financial to all committed for access have are to appropriate We now our will ensuring

Charles R. Eyler

Steve. Thanks,

me financial commercial comparisons Let year-over-year company a of QX of Please better make and quick with start of of QX our quarter than believe for note which XXXX as a XXXX. summary that progress results we indications the will comparisons. third are our to I

recommend For information, include which consolidated be XX-Q, on filed will Monday financial I which to refer statements. that our more and you our

GAAP For million loss $X.XX XXXX, $XX.X reported the of per we on or third based net of a quarter share.

$XX.X net On GAAP $XX.X respectively. QX diluted the net share of and income loss per basis, of QX non-GAAP quarter Our fully XXXX million, and a reported million or third $X.X of for million were we $X.XX for XXXX.

mentioned, Steve NERLYNX revenue for and $XX.X of sales from XXXX. Alan net versus were As million $XX.X second quarter million the

was a the Our million. payment included of year-to-date approximately gross amortization is $X $X net of reduction million, to the third a sold quarter of of licensor for Cost milestone to which X.X%. goods neratinib

for to per amortization licensor payments million Going $X the sold. forward, will of recognize of quarter cost the about continue milestone to we as goods

As sublicense million. quarter of XXXX, revenue third the of aggregate Alan in recognized noted, we previously also $XX

fourth a million sales sales in seen have to $XX.X October. estimated an start quarter gross We good in NERLYNX with

XXXX the million in product maintaining revenue new experience case in sales million are our know would holidays. caution a We we on patient guidance in fiscal will be respect $XXX not of slowdown of if we in year this. to to to $XXX due do November order NERLYNX this, December we to and conservative to but with net We err the side starts experience like

$XX.X of third coming for extended this for million compensation $XX.X only reminder, and the $XX.X million million and charges and of million million partners. stock- QX compensation in Research compared and currently million to expenses our $XX.X XXXX respectively. included were for QX stock-based compared $X.X guidance the third licensing QX XXXX, quarter expenses $XX.X XXXX approved adjuvant and for million compared indication SG&A respectively. QX respectively. charges million excludes a SG&A revenue the million and revenue and $XX.X $XX.X for for respectively. R&D $XX.X expenses for As included million for were from received includes and expenses based the compared $XX.X of third non-cash QX development of million QX and million $X.X from to $X XXXX quarter to to non-cash QX, quarter, QX

used QX cash compared operating for million to in $X.X and XXXX, net $X.X and million $XX.X the for XXXX quarter of approximately Our activities respectively. was third million QX

cash million, anticipate in Our flow of We and was we cash equivalents QX $X for operations $XX for in burn reductions third $X million the cash burn positive. burn neutral, fourth quarter approximately cash $XX.X for flow XXXX. XXXX QX cash We our the for by and million continued of compared to to million approximately that such cash $XX.X transitioned with of third securities. will million about in cash XXXX, quarter have and quarter marketable the ended

Our accounts receivable at balance $XX.X million. XX September was

trials while three accounts receivable sales inventory. days, neratinib weeks to about resources we approximately terms XX the and deploy Overall, our the to range specialty are financial outstanding to days. ongoing commercialization continue The continued clinical Our maintain our NERLYNX. between focus and advancement XX days pharmacies of XX through of on of

Alan H. Auerbach

Thanks, concludes XXXX, for patients, of expand move We'll to HER-X have from Charles launched NERLYNX forward continued the cancer and commercial advance we receive beyond. positive to and stage today's to the of XXXX presentation. of feedback for payers. This breast and and with XXXX, continue the Since Steve. third in treatment activities early our quarter prescribers balance we positive plans our

operator turn the now Operator? back to Q&A. will We for floor the

Operator

Thank you.

with We Augustine Please And question-and-answer your with will begin comes our now the proceed question JPMorgan. from first session. questions. Carmen

Carmen Augustine

taking the question. guys. for Thanks Hi,

just July lead quite substantially behind active of kind of But of of when number this follow that restatement? about to that patients, number that we on what and is of kind of between see changes fell quarter magnitude you some at looking to exactly XXX first, go the So, up. and those kind you month, drug changes could detail you kind on could the patients alluded of the by

Steven Lo

Certainly. This is Steve.

receive channel, my patient our whether As script, pharmacies, and us for the from cetera. active, from which we XX% accounts week receive of is will, mentioned in a data data once our et course, a I specialty we tell they of them

that, patient, get audit patient, reach top ship et data We of pharmacies, is XX specialty refill, the these to them also their job days. to of cetera. try then And a every part the to on to

XX again, who again, in difference do see completed well would So, that the is therapy. what compliance. of to subtraction it the days some we be up-to-date adherence patients could is have as because, and up July updated until Therefore, with patient the be discontinued, what the you they receive the part potentially to data who help of as information patients numbers, most that on, in

Carmen Augustine

Okay.

that they to So, sorry restated so did them discontinued from on follow-up in the got just number? they mean drug July you on they July on removed that and that, does get then or drug never

Steven Lo

Yes.

census So a to clarify, we every month. do

I only you So, week the that to you earnings number July. to And whenever the we August time as in call. in we July, imagine our we this do this that point and we believe a August was of can last that's again, believe out the August, or At closed was we since X,XXX. showed essentially compared month had, two

who course receive next month. that was during discontinued had patient out XX So a the who days of to throughout that July we'll active there updated was the information find

Carmen Augustine

Got Okay. still. down if launch should bit odd to from question And SG&A one as is then as that financial SG&A about sequentially here? you we which a growth struck how well Could as the given little we're could. speak phase in think us just year-over-year I it.

Charles R. Eyler

This is Charles.

occurred reimbursement that class One lawsuit. been regarding had had the action related third fees that is our the in of we legal a quarter check to things

the Some had of third in and check quarter That $X.X those fees for was million. were carriers. insurance with resolved a being about the received disputed we

Carmen Augustine

Okay.

we continue expense from kind growing here? should So SG&A about to of think

Charles R. Eyler

expenses our the sales those commissions, the will marketing grow, sales well Yes, as as continue grow to particularly with aspects sales as certain program. of force,

Alan H. Auerbach

we obviously, are completion. a R&D, on question number of your that nearing have trials answer to then And

you less occurring, monitoring R&D go of expenses active, down. going to sites as patients less have So are

been have would sequential that down expenses I so see guiding continue. we to starting we trend think I R&D would yeah, anticipate probably that So, would

Steven Lo

I'll add related SG&A. another Steve. And is Yeah. comment this to

active, on potentially who programs. in and are many are adherence the of programs our based compliance number of patients are So,

on of to will reason increase more because those drug. expenses some patients it have So, we'll that stands

Carmen Augustine

Thanks. it. go Got Okay. in now. back the We'll queue

Operator

Thank you.

Yigal Our your question. next Please state Nochomovitz comes Citigroup. with question from

Yigal Dov Nochomovitz

in what Yeah. of get better Hi, off leveling like looks you're thanks. with reached. prescribers you're XX%. of target in trends is around regarding Is at designing XX% how able things a you the getting some yet? seeing that I'd terms that challenges they're haven't to that just regard sort access understanding there or of to to like to sort Thanks. reach It been

Steven Lo

Yeah. the the is question. actually sales pretty representatives. Thanks for oncologists We're Yeah, much of world. lots in that finding to globally oncology now this their certainly academic access and institutions close will

this here, at places We that They're as which we certainly bit. So medical conferences. see we in northeast we which other about don't the is numbers physicians. it doing not have we ways count unexpected. in a such do are is reach What these quite

We place. to physicians. We online other rest there do direct But because also in count few rep-to-rep programs ways those a have don't it's reach we have in e-detail and assured one-on-one. interaction a not

Yigal Dov Nochomovitz

it's prophylaxis the regarding market talked rates colestipol using budesonide Okay. or have of which the current Thanks. of of out others? a of do percent different about of you in way you versus the for terms the physicians discontinuation in some are the And what loperamide currently versus broken in terms maybe snapshot regimens,

Alan H. Auerbach

Yeah.

highest that rates. discontinuation information, loperamide. only you'll Yigal, label the that the And the FDA FDA in was in the remember drug prescribing had was So, the put the that label the one in that approved

because and – helpful. more our the using rates awareness increasing to referring we increase the arms update of that's I what's efforts are that of believe Steve colestipol majority both because be We're label. of was much to the they where discontinuations. loperamide will better probably have in don't budesonide get the that's very just and to So, And exposure them label try

Steven Lo

Alan there. exactly right Yeah. is

snapshot have will small program. voucher a We based a on

of medications. program for last most from a help access So there, a have voucher data quarter, antidiarrheal launched the voucher to again loperamide. And are small the patients redemptions to we number,

ensure physicians other the because for exactly regimens. label antidiarrheal Alan what looking to ways is So are and that in of saying that's aware we're the other there

Yigal Dov Nochomovitz

the then you – that And Germany it the there just quite not to launch, with Okay. yourselves a obvious XXX% is It's the own or your plan wasn't yet? is find It's Are what clear. on this or partner determined is to yet. just strategy launch been not employees? –

Steven Lo

Okay. Thanks for that question.

and the we a Last which there. every started of to We're in working the our supply intention process G-BA be Germany. meeting First authority them. had is foremost, launching with the Germany pre-advised ourselves. have we supply with to reimbursement We've on already able year, chain

know, before reimbursement most in As there first you the because the to of may launch ability Germany country price is determined. will that companies usually is

to are the do path. the other versus have stated who we we been with in he opportunities Europe. best exploring a before, that So ready That's with we'll as certainly in companies parallel At do for that. same what's time, It's have not partner here. shareholders partnership and could And us situations, one stated another. Alan

Yigal Dov Nochomovitz

the end was, final our the U.S. the before going then be it introduce you're expectation question And XXXX point Okay. of revenue that my guidance at the should for some Thanks. market? to year

Alan H. Auerbach

if we will I know at the year point, do early will next end if But XXXX believe we revenue absolutely. yes, will of or I something before the guidance year. it do we don't some at point. some it introduce be

Yigal Dov Nochomovitz

Okay. Great. you. Thank

Operator

Our next Cantor state question comes Young from question. Fitzgerald. with your Please Alethia

Varun Kumar

Kumar This Hi. for is Alethia. our Varun

color patient are patients provide I if any question the active start new on Just can my increasing. first you understand trend. on,

entering trend evolve? So, patient think XQ, new we should will into the how

Alan H. Auerbach

Yeah.

numbers in us. of have So the we I don't front think

comment can't it. on I So

in the good that changes patients at looking a is probably seeing active just probably trend you're think month-to-month I the to assume.

Varun Kumar

Thank one. you, And Alan. final one maybe

subpopulation. sales being how specific of of understand much by trying NERLYNX in the a the is restricted just So to users

based any So, real color status? HR on the users on world

Steven Lo

Yeah. This is Steve.

it's know for the they physician which And There entire the for. they for you treat for labels recently intent population, did are we to NERLYNX of surveys NERLYNX understand as our population. intent to treat prescribing entire preference to prescribing are patients safe So stronger board are those is course hormone We who a it's more pull to it that and the charts do But say – node-positive receptor don't small in physician lot is hormone groups. receptor node-positive certainly a across that to patients patients the with audits. positive, survey. again chart

Varun Kumar

Alan. Okay. Steve, Thank for questions. you, taking Thanks my

Operator

Thank you.

question Bank Please Ying with of state comes from America. next Huang Our your question.

Ying Huang

Good for Hi. my afternoon. Thanks questions. taking

a First on I discontinuation rate. the have question

question You have patients adverse typically you beyond early overall about beyond mentioned Can few rate then overall a And the weeks to treatment. months, AE? like in months discontinue? spread I then talk or due of XX discontinuation around when of in still a it terms or also that does few of kind XX% it's discontinued who And of happen have that are patients events. on patient the

when You number that start they Is a the NERLYNX, the patients – beginning, it's take have from here? mentioned day when when XX take they months you. denominator a Thank who it only first reached comes or as XX%. using cumulative to

Alan H. Auerbach

it? you take Steve, want to

Steven Lo

Sure. Yeah. Alan. Thanks,

of first the So all, yeah. on discontinuation rate,

compare category. adverse which amount there's also rate There's patient, include them specialty which is pharmacovigilance XX% come a get you They So who then issue we up to to another XX%. data, our events. insurance that to when a around category the general drug. But – and physician we is put a pharmacy an the gave I we on overall a The specialty with very audit to data could adverse we And choice for pharmacy. behind reporting free remember, an are that specialty event it have distributor. rare the going but, transferred discontinuation transferred twice patients discontinuation rate drivers number cases,

a there. that's number firm pretty So

mirrored you seeing discontinue, do question closely around they second days. with well trial finding general, in antidiarrheal. This typically within I physician is that that earlier, ExteNET. first giving patients when XX them we're enough aren't to as was We're survey, it's them of XX% as if CONTROL with usually patients as when the shared very Your do. in discontinue the the Interesting

on. think have who the of who there, that looked I question We months therapy. hope ready so number complete. third cohort and cohort, And with months to of more education at them reached your of getting the around And was XX that they're improve. patients XX% go XX had And then we past will only that continued the patients of

Ying Huang

patients number have changing. I last If it I follow-up. the And that. mentioned, difference seems been becoming the you back But of as you to that look quick is for active that much quarter, obviously, the a slides presented noticed I very – wider. Thanks it's commercial

XX, at two last today between XXX. X,XXX in time But then reports June example, May, the was when I in reported looked and quarter. delta it's For last and you the July,

Now, to-date X,XXX. it's

Now, the XXX. difference is

how just I have So is you this in reliable today's October wondering slide. was number

Steven Lo

from gross the going We was important the are you us will be Charles to Yeah. thought reliable what now, what be days well. for that with very sharing it And to more said days from reliable we just for is XX full October before. transparency, I snapshot for with month little that share that a XX now. It's as more October the sales with had you in way same of in the consistent

Ying Huang

Got it. Thank you.

Operator

Our next question. Guggenheim Schmidt Please your Michael with from state comes Securities. question

Kelsey Goodwin

point? that at will you by We're obtain guess guys approval for wondering, Hi, just Roche's treatment? it this how NERLYNX market KATHERINE is Thank how Schmidt. FDA might adjuvant does the affect the in will that you. that is are NERLYNX I some assuming Kelsey potential be Goodwin and – behalf or Michael opportunity about how thinking trial affected treated Kadcyla on if of question. taking the Thanks

Alan H. Auerbach

Yes.

the Herceptin receive that study complete So, T-DMX did in adjuvant Kadcyla an is therapy. not that patients KATHERINE to a to neoadjuvant comparing trial is response pathological is which

things few on design a of So, the KATHERINE.

patients practice that in based adjuvant is Herceptin adjuvant plus The would these due receiving in the on right setting. Perjeta trial, clinical approval the first Perjeta of to APHINITY now the be

arm the alone, is current control standard the not just KATHERINE Herceptin necessarily of which therefore, care. of is So

was KATHERINE that the all patients when of the Perjeta the neoadjuvant second trial patients, available enrolling was timing not neoadjuvant because when of in the The received enrolled is to Perjeta not trial patients. due worldwide

the reduce patients Obviously, understand to gives Now in the them better. of from the is but look, going going goal of certainly We're trial, anything that and to results option both risk know need to don't and the the to are results terms recurrence. show, the wait of extended another the treatments results what presented great. adjuvant I setting those see risk to is adjuvant in high

iDFS in kind the rate rate did receive trial, our study arm APHINITY of will ExteNET reminder that in these population response investors, five-year neoadjuvant So, to a reduce think the iDFS KATHERINE look to complete the patients look, five-year is there's the in of with is obviously at I Phase if and is need as what we of is, to example, Kadcyla going need patients XX% what were of much these the and saw And not additional to the for to in five-year the then still trial risk we be yeah, is which pathological going the patient is then, KATHERINE treatment. in further what trial XX% which they in additional to similar rate for the to that to similar be not If recurrence XX%, the iDFS the patients. to a there's for ExteNET risk approximately risk. III trial they

efficacy is. who mainly That's Antonio which Cancer Breast year, presenting patients year And the So, the of at on this less a looking the efficacy that specifically Herceptin our a hormone that Symposium ExteNET. did in the EMA we'll of are be response adjuvant the what ExteNET than patients is from San pathological and also, label their achieve and in not receptor poster for trial, treatment. positive the one be basis we'll at complete completion

risk to clearly to fact Their to additive very recurrence. So at seen to of XX be data disease receptor recurrence efficacy whatever the group add as it'll a of patients KATHERINE. due the efficacy see years. the you hormone a that can Kadcyla be in risk to And of go from positive way know, look good tends with neratinib Kadcyla have what is KATHERINE. in would term could longer that out we Whatever much

Kelsey Goodwin

more so first Could you Okay. thing, tumor a label that discuss expanding with that? And I agnostic of on speak a into meet mentioned could more Great. quarter Thank bit speak label. FDA possibly just then know one in you the and you much. could the the you XXXX bit a little possibly – you just maybe

Alan H. Auerbach

Yeah.

is HER-X to this mutations. with the regard So

study have As you neratinib. looking know, is basket trial. ongoing we SUMMIT, which a It's at our

at solid mutation. we're all So it's HER-X agnostic different a tumors with where that looking patients a trial tumor have

as got FDA seen fusion it the we've the it tumor agnostic MSI-high. granting indications. I got certainly for well. I the for know TRK-A So know LOXO KEYTRUDA

there So it's precedent seen We've here. Yeah, not something regulatory is new. this.

So of to the study. our currently plan on is to meet SUMMIT the in with have path and perspective, the data from kind forward, in we FDA the XXXX clinical discuss a in QX based that regulatory order of

Kelsey Goodwin

Thank you much. Great. Okay. so

Operator

Shibutani Chris from question. Cowen. state comes Please question your next with Our

Chris Shibutani

what and still – and third thinking about It if the X Yeah. that have questions asked. seeing laid more scenarios that savings. NALA you. reverse little a cost? we a know for that clarify continued where fourth bit cost and more opportunity this and X you sense. you a of believe negative go through the many to In not describing Thank well. you're behind if there. you're the trying But bit your in the the I a metastatic again, could I'm you thinking have positive would the a OS, to been get you have outcome be little out, I implications better the and sounds as Alan, you're expect how as is particular, that about PFS, be scenarios to how can options But

Alan H. Auerbach

Yeah.

you at panels OS. trend OS. in of had have I FDA know trend a a accept So that's NALA if said up where end the they would statistically significant outcome a FDA you PFS having in the PFS but and previous

we but obviously, to beforehand them from would – yeah, about would speak need plan that forward the move to to would that perspective. that So be

a preferred the but significance OS FDA, would do PFS from see in regarding the and get positive surrogate PFS OS Now, statistical maybe but hit if a statistically a a you agency endpoint, the assuming doesn't result you speak a is endpoint OS, on you but – on negative see as again, know to you is PFS again, that. significant it we trend usually

Chris Shibutani

to also would European these And you that approach be scenarios ones you'd consider regulators?

Alan H. Auerbach

believe regulators, said other countries well. I When Yeah. speech, It as Europe yeah. to we in talk would say the regulators. and both be we U.S., my

Chris Shibutani

mentioned taking about you off-label experience, And as up previous you. counting out that that drug were secondly, what use comment had there second follow patient comments then XX summer for Thank far last And talked the year. during use just the some in you're the currently? How X% the played to U.S. in as then in the past, you – initial had were patients for the longer quarter seeing Can over you two patients use? that who NERLYNX than things metastatic metastatic about months. from about possibly current has for

Alan H. Auerbach

don't don't now. right that and setting. any of the see think brain we terms options feedback in a capecitabine from lot third-line we Europe, in we I and physicians the off-label the in – is majority now the access mets use HERX that we metastatic in also we of have metastatic, there's is up So use, in with from we program really of and expanded of that I off-label our the in get metastatic the our a kind Because know program, X% combination more our use MAP mutations. anticipate to lot of see

in would and we're is mutations. the mets probably brain say the more X% I So, the seeing majority in HERX the of

one his of longer at than out XX% year, we had believe and question that, in comments Steve going a patients now that on the On said patients. also I is

Chris Shibutani

it. Got

Thank Okay, great. you.

Operator

Thank you.

comes next Kennen MacKay Our RBC Please question question. your from Capital Markets. with state

Kennen Mackay

of housekeeping repeat One wondering Hi. was slide I then outgoing help for sort many Thanks slide what you how perpetually the of the understand if question. is are And average prescriber prescriptions. X, I'm us wondering in your taking prescribers. on of these dose question, could sort on intensity

the became sort challenging back about the sort of experience a still come that prescribing prescribers toxicity it the with are earlier sort prescribers don't associated what of who there that? of NERLYNX late some of physicians instance, of to this year, in have or that some cumulative or and can drug done be year they some last managing For then are

Steven Lo

Yes.

recently, the conferences patients label don't We we inhibitor intensity, have numbers that dose. is lower full side dose that who up anecdotally physicians tapered that on the And at the around kinase know titrating have a with the set the of titrate I they start exact their don't would the is question from label. start first be and starts in receive up. way do of be pharmacies. tyrosine medical the some that experience other your say quarter, will the the due So, education and know because to have most down per because last would up. they there dose specialty level that been been dose I on dose effects, do detail we

physician at we So that. least are hearing a don't have we but that seeing surveys, the in on of that and quantity some

north but the regarding from question only NERLYNX, we not have the specialty that data your again patient. pharmacies full about channel of know for of we're terms we and prescribed X,XXX one the for of prescribers In X,XXX them have prescribers

are most those prescriptions. of However, recent the

to then that's So options. be the that opportunity and physicians fact your the they around the certainly look diarrhea returned. promising. those And And one is they new are would getting that prescribe of where to some really understand for are patient sure way they haven't making the question – I very we're at week that is prescribers there that going which there every

make earlier, some sure are don't have the using physicians who and prophylaxis I of have that, team doing have most positive that As anti-diarrheal I options. our been and aware experience. physicians believe the anti-diarrhea probably they're the those back there used who not stated goes And

Kennen Mackay

of execute rate U.S. you've drug. for the at this execute now market in just you. follow-up additional about an sort of guess more of last million talked to had the And And operationally Got is really really $XXX I high to having the least thinking question one conversation one that demonstrate Alan. for then commercially got level run the sort over I that points and we was that about year, feasible.

about You've be, more day the out about the teams of recognition got think the space. have metastatic your then are do active as maybe the Amgen the you back eyes where NERLYNX, other potentially valuations Europe, pharma. in that well upside We sort cap sort cap how of biotech, from was becoming in eyes this guess, BD there full of setting. large about you come as cap guess they're as heard in will I of I in in asset sort CEO think and value that talking recognized of and also large of thinking SMID wondering

you're NERLYNX interested of full thinking about in where sort being value of the So, really recognized.

Alan H. Auerbach

Kennen. Thanks,

think NERLYNX in sales, market the in I in NERLYNX, terms that value terms in States. now right we have of United of of drug the the the

Next in will to revenues start see year, we coming in, Europe.

East, We partners royalties in China, will in see from South also our Australia, to Latin Middle the coming start America. America,

So, through I recognition think better opportunity much XX a revenue the obviously worldwide we months from will and of now, indication. the have extended adjuvant

both execute metastatic obviously also in well. as upside also the get to well. as we regulatory and obviously, have from those offer the opportunities on HERX-amplified And setting additional from HERX-mutated. But the Now, agencies, the guidance those some get get we the and from need – then data those,

as that availability will So, any think execution, sales. will recognition see we especially value just I certainly see we more worldwide, like time, we that get through commercial NERLYNX in

Kennen Mackay

your something Got Thanks, need back appreciate is I Thank you. on to I HERX-mutated that the at. thoughts Alan. and you. market look

Operator

now I today. remarks. Ladies to closing Mariann we questions gentlemen, for will Thank the conference run back have turn out for of and time you.

Mariann Ohanesian

We interest your appreciate in Puma Biotechnology.

webcast in As may a accessed beginning your call about of a this and hour. today. by at an reminder, pumabiotechnology.com be time the attention replay for you Thank

Operator

day. Have disconnect. may parties All webcast. today's concludes This a great

Puma Biotechnology (PBYI) 2 Nov 182018 Q3 Earnings call transcript