Earnings call transcript Q1 2023

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Operator

Good afternoon. My name is Rob, and I will be your conference call operator today. [Operator Instructions] As a reminder, this call is being recorded.

I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of Investor Relations for Puma Biotechnology.

You may begin your conference.

Mariann Ohanesian

Rob. you, Thank welcome financial and conference to call Good for to the our results XXXX. first discuss afternoon Puma’s quarter of

on Nougues, Officer. Chief are today Officer; and President the the Chief Chief Financial of me Commercial Ludwig, Board Maximo Officer, of and Alan Biotechnology; Puma Jeff Executive Chairman Joining Auerbach, call

via are financial will Investors today, release, presentation call the news at closed news will refer website accessible and market of pumabiotechnology.com. The for That be and our website homepage issued After of our webcast release detailing that days. Jeff replay results. a Puma the sections first to a quarter XXXX slides on next for webcast slides and XX the and available archived this

about prospects statements. these plans future results purposes and statements the may are statements Such for uncertainties from Today’s company’s that in federal forward-looking to those conference and forward-looking securities laws. subject actual differ of statements will expectations, constitute and call risks include expressed

these including For time, periodic ended XXXX. the to a time the full discussion XX-K on SEC from for filed risks and current Form XX, reports and year please annual with report our our December review uncertainties, of

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

useful our refer release financial GAAP to non-GAAP for substitute news financial of to to GAAP but a also we that measures fourth XXXX involve metrics to figures. to GAAP non-GAAP may for supplement as believe our quarter a call, to, We today’s reconciliation Please results. non-GAAP investors a not these our measures. our refer may be During adjustments certain

will call now over the Alan. I turn to

Alan Auerbach

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

sales, quarter first our million. which Product and from revenue product royalties was for first which revenue reported includes net, Puma from XXXX of well the of a $XX.X revenue revenue Total NERLYNX million $XX.X a from XXXX Today, total it as XX% of as of of entirely QX net sublicensees. $XX.X the decline million expected represents XXXX. reported million reported in in increase represents quarter as $XX.X QX in consists XXXX,

and the quarter by first for million was approximately drawdown XXXX $X inventory $X revenue compared to Royalty quarter revenue QX impacted million XXXX the of of in XXXX. Product in pharmacies QX in XXXX $X.X of was specialty of at $XX our and million distributors. specialty first of million

We XXXX reported compared the bottles XXXX. bottles sold in QX of NERLYNX quarter of first in of X,XXX sold to X,XXX

we to slides. will QX XXX XXXX, prescriptions and on new to were compared or noted In approximately Jeff we further approximately NRx, up provide X% last his estimate prescriptions, amounted bottles. in build total As were approximately QX inventory that quarter’s details compared QX call, XXXX. XX% comments XXXX, and to QX down

follow add will statements additional the of of now on fourth for commercial of and components then Nougues color clinical Maximo provide the Ludwig will financial quarter I will our with quarter, key NERLYNX review of then a XXXX. activities. Jeff the highlights

non-Hodgkin T-cell cancer and drug cancer, treatment of breast and in lymphoma in date, was lymphoma. As cell trials, in and triple-negative Takeda. from pleased cancer, in-licensed that previous activity clinical single-agent clinical activity alisertib has shown investors in The other XXXX, lung cancer. hormone-positive small has In with the also drugs neck anticancer September aware, Puma alisertib including head the activity cancers, peripheral various had drug, combination are to anticancer to we and breast shown announce in trials

well-characterized And with clinical due clinical are with previous over program patients treated a across X,XXX was extensive. company-sponsored large safety XX development this, trials. database is alisertib Takeda’s to who there

second in cancer of currently late and We -- XXXX will subsequently the anticipate in with clinical of quarter substantially with the fourth for in lung that anticipating initiating meeting lung FDA be we are to alisertib small of trials in cell quarter pathway cell discuss XXXX. alisertib the the small registration cancer

cancer. pleased In alisertib patients March, Oncology. we monotherapy randomized trial fulvestrant in the alisertib HERX-negative results clinical was are that in with to receptor publication announce positive TBCRC-XXX versus tested a This plus JAMA of breast from hormone trial

We as of resulting are patient in this alisertib pleased the biomarker a population, as in publication. activity to well analysis see the

Network a versus April paclitaxel JAMA cancer. progression-free Open XXXX, data published second from received plus the with anticipate be in data alisertib this Oncology statistically As cancer, poster of breast Clinical American received of survival the was compared Phase biomarker in who Annual the in further a with half that in from We paclitaxel hormone Meeting investors alone. receptor In paclitaxel randomized FDA showed trial or with paclitaxel metastatic significant of positive patients patients anticipate patients also XXXX. as the benefit a June. in trial X will HERX-negative are aware, alisertib patients to at ASCO who data in We Society plus for presented the breast meeting

the subsequently receptor hormone HERX-negative To receptor for cancer registration XXXX. positive first discuss alisertib hormone HERX-negative of in half the in clinical breast trials breast and pathway of initiating positive in alisertib cancer

includes will I that program alisertib paclitaxel which, will versus at of mentioned anticipate ASCO June. positive the biomarker alisertib be from trial the alone presented This We months. data paclitaxel in to several breast clinical receptor in in milestones mentioned, plus be cancer, randomized continue the as the coming previously home there HERX-negative for

treatment anticipated breast and with discuss X/X which the we registration plus lung for squamous discuss the with alisertib second pathway half QX neck cell of conducting anticipate from of the patients head ongoing deficient of is the a to XXXX, trial and the to alisertib anticipate Phase XXXX. of RV pembrolizumab investigator-sponsored registration meeting in for conducting HERX-negative meeting FDA XXXX cancer, FDA cancer, data alisertib in in which in the cell small we positive late which receptor Also, an in the sometime cancer, pathway and with home

As Puma to and that keep Puma’s diversify calls in-license drugs allow progresses. leverage R&D, updated it potentially to and in company commercial investors investor response itself mentioned would and on regulatory questions, continues The on will existing to to earnings the evaluate as prior this company infrastructure. several

Officer, I performance will call Commercial the commercial now over Ludwig, Chief our turn a of Jeff review to the quarter. during Puma’s for

Jeff Ludwig

it, Thanks, thanks joining to our for call. quarter earnings everyone Alan. first Appreciate and

will reminder Before I move a just be forward-looking statements. review, the I into that making commercial

the continues the patients with Our reoccurrence. risk commercial focused extended reduce goal helping strategy more their of indication to be adjuvant on largely of

battle continues HERX-positive underpenetrated made, support breast needs to and progress be cancer. this be Although to to in market their done patients is with more

around is to extending and increasing commercial patients reach better to educate and NERLYNX. our frequency promotion the risk profile team focused of Our well our as and reoccurrence outreach HCPs risk-benefit via on personal as the nonpersonal of

Our the in and goal growth. is adjuvant consistent penetration extended to increase drive setting

with refine regards QX, pleased versus of quarter-over-quarter. in increasing team and goal saw in nonpersonal that to tactics promotion worked strategy of to am calls, live and QX, XX% and Also calls virtual. XX% Specifically we I QX our the relaunch some impact HCP marketing these about were evaluated those our And in increase of approximately beyond.

that outreach our advocacy commercial continue high-level detailed With nurse around the to of to local let educators our clinical for on Lastly, expanding over will our and regional Maximo some some U.S. Once I’ll specifics to provide turn the to review I commercial organizations. call by transition update, focus I’m more very of a slides led where additional team results. the finished, financial business. me the

Now moving Slide to X.

not distribution specialty channel channel see of through to as some that our in our Our patients. specialty pharmacy in-office provide flow SD separated channel. channel, pharmacy performance stronger and business dispensing we or Most specialty and model the refer channel. to but our to continues QX We channels changed remains into distributor distinct the has did two these NERLYNX

In through overall channel, distributor the specialty went the XX% business did through our specialty remaining of the change the channel. from of approximately So XX% QX. QX, going business the split pharmacy with slightly

and a reminder, we SD XX% channel. went the QX, specialty in through the As our remaining went pharmacy that the of business channel reported through XX%

Slide net since of Now sales FDA NERLYNX X. X quarterly moving shows U.S. Slide approval. to

our XXXX numbers, and additional of were of $XX.X quarter sales This clearly first in from QX product me insight. decrease on you $X.X increase an these some Alan XXXX. give net the million QX million million a from have As is so let Inventory noted, impact a changes XXXX. $X.X of

inventory QX, decreased estimate million. that we by $X.X In about

about As in that QX and a $X.X estimate inventory million by XXXX. of QX $X.X we decreased million about XXXX comparator, by increased of in

specialty distributor which ex-factory shows is sold NERLYNX bites launch. into not X represents pharmacy this higher our lower and the since to We Moving bottles it XXXX, sold of slide that of about in X. XXXX. user Slide XX% Please XXXX shows of end of QX sold, than X% channel about specialty compared of Slide and and by to QX sales demand. X,XXX QX note quarter so NERLYNX bottles

insight Now XXXX. changes here. inventory again, quarter models a me decreased estimate inventory that of provide first let XXX by more around the little in We about

by As inventory in by QX increased that estimate and XXXX. in XXX XXX decreased we of about about XXXX, a of bottles bottles comparison, QX

year-over-year. on driving the execution goal and quarter-over-quarter team Now with is focused the of both commercial growth

in key or X% to QX, and patient of Given about a decline NRx, of regards In around we starts new this an growth saw commercial X.X%, a year-over-year. about XX% metrics. enrollments few quarter-over-quarter priority, let year-over-year. me specifics provide saw growth some more growth we a In quarter-over-quarter but XX%

decreased in increased about we saw turning SD driven Lastly, channel. quarter-over-quarter X% year-over-year, by QX, demand growth but strong by demand. In about to X.X% the by

X escalation. adoption highlights dose the of Slide

as diarrhea, improve reducing by escalation Grade what XX% the is diarrhea. who of approximately started discontinuation median significantly X to it days Grade lower dose, we reducing In of NERLYNX QX, decreasing important a daily received to is We an that which NERLYNX to drug believe in QX X of continue commercial XXXX. metric serves on the patients similar reported rates tolerability dose of and

escalation. to with We escalation extended happy dose setting. starting full that benefits do have included continues of including on some said, escalation With in the metastatic start full overall the in guidelines, to setting NCCN. around dose many educate commercial and of are in at dose I’m the some comfortable to the pleased and discuss the physicians adjuvant and dose adoption prominent prefer team that that see dose

extended globe. QX in launched of the in NERLYNX Morocco regulatory Also across Slide X Mexico have collaborations approval and QX we In the both South are to regulatory Colombia. announce metastatic formed the that received Africa in approval setting officially in adjuvant setting. highlights the the was XXXX, we received in in happy in adjuvant setting XXXX, NERLYNX and extended

launches. future for partners Our highlighting look to moving I driving increased continue adoption preparing forward. global on progress continued forward focus to and their

I I on a for to my battling continued colleagues commercial efficient effective for share broader as their want want thank Puma bigger thank and they to patients a to broader a breast also on we and impact patients. cancer. for know also impact more organization I dedication becoming make support partnership. strive to making their passion the more

I’m full now for review over financial of our turn a Maximo to going the call to results.

Maximo Nougues

Thanks, Jeff.

summary QX a as our I make comparisons. our XXXX, than XXXX. the first indication progress note to will which brief comparisons a of results better of year-over-year believe will we Please for of is quarter a company that begin I financial commercial with

financial today recommend QX and For filed refer to more that statements. XXXX you information, consolidated be our which XX-Q, includes our I will

first the the we $X.XX expense, On of impact of basis, per of $X.XX a loss million based per quarter million share. a income of stock-based income $X.XX first non-GAAP we The net of net million to compares quarter XXXX, XXXX. $X.X reported or in compensation which XXXX share to for or This $X.X of or remove $X.X GAAP on is share. per net QX reported adjusted

revenue $XX.X NERLYNX XXXX million was $XX.X in QX sales and from Gross million XXXX. in QX

inventory that drawdown million NERLYNX QX from China. impacted reflects QX net Alan The $X.X in sales the product partner As $XX the approximately QX in of to $XX.X in were We in the XXXX. from Royalty totaled mentioned, reported believe revenue million was million XXXX $XX.X compared to distributors. sales first our $X royalties by net revenue versus million timing quarter lower to of shipments million of XXXX. QX our compared

XXXX driver net XXXX QX sales to of XXXX XXXX. was Cost QX to Higher of of the reported including related of in was our was million. $XX.X XX.X% main XXXX. $X.X the for neratinib $XX.X QX million intangible was million, for sales QX amortization to license. gross XX.X% adjustment increase co-pay Our versus adjustment QX net compared the assets Cost to about gross for the in

amortization about licensor milestones of cost to will million the recognize of sales. quarter we of as $X.X per forward, Going to continue

fiscal be $XXX that will anticipates $XXX of For to product the revenue year net million range Puma XXXX, in NERLYNX million.

gross We year and also adjustment anticipate XXXX that will be for to between XX%. full our the XX% net

for the in partners range million the our expect year from million. receiving royalties world revenue license XXXX. We addition, anticipate to In in fiscal XXXX, around we don’t $XX of the $XX

We to expect may the full uncertainty of in license and countries income revenue. continue the year great to be of We the also especially this recognize of impact deal royalties outside be in that and will sales, there continues COVID-XX, to our net million for $XX impact of a $XX range regarding the negatively million. U.S.,

the be the we in $X will We $XX range net Also, further a that the in for XXXX range expect between be $X QX profit We $XX will gross to million QX net million anticipates of be to NERLYNX XX% to $X $X.X revenue million. QX anticipate in of approximately net royalties million. XX%. million adjustment that Puma of million. XXXX, QX sales estimate will and

for the in million $X $XX.X million quarter XXXX compared XXXX to noncash included charges quarter. QX. million SG&A $XX.X for stock-based $X.X expenses to of fourth third of QX the were expenses compensation SG&A for for million compared

million million expenses expenses fourth stock-based development quarter the of to were in for from noncash $XX.X first included charges first XXXX, the the quarter. fourth XXXX of quarter. and quarter of unchanged compensation $XX.X Research for million the compared R&D in $X.X

legal earned XXXX. $X quarter of related first QX reported $X.X of XXXX, related and to approximately to the million payment cash Pfizer of in million made to the million a XXXX, cash global approximately a payment million burn revenue Puma of achievement QX compared $X.X In to In milestone our we settlement. $XX.X

to in operating to expenses XXXX. R&D X% decline expense anticipate expenses to total to increase a continues we side, X% compared to XXXX approximately Puma specifically, The reduction to More in X% expenses SG&A anticipate year-over-year. X% and

XXXX, equivalents cash March On securities. cash, and in approximately had we million marketable XX, $XX

Our accounts receivables balance was $XX.X million.

three range our days XXXX, Our our distribution estimate We XX as and XX that weeks terms XX, sales are accounts March inventory. receivable XX about while network days. of between outstandings days, approximately maintain

Overall, to controlling we continue commercialization of our expenses. financial of on ulcerative and resources to NERLYNX, the our focus deploy the development

Alan Auerbach

Maximo. Thanks,

of management In to able improving cash XXXX. continues order in of We in the a the Directors NERLYNX net sales reduction the fourth XXXX remain and operating are on implemented to pleased goal in Board positive quarter beyond. with the quarter expenses cooperation income in to focused of XXXX, with to of during maximize be we achieve reducing expenses first flows. Puma senior

flows expense reported positive flow these is a achieve for a We committed XXXX. operational expense quarter guiding income net company achieve continue was remains to direct net year believe the income cash income, positive to and if we’ll that continuing positive of These this. also to to that reductions. expenses cash the positive to the major needed and in reduce these result are the The contributor reductions to full company and first net

strive patients future. investors about unmet We at during effective battling solid and in this look cancer, lung goal. forward ways and passionate remain updating breast and a to helping There journey, continues these need committed to for significant continue to that We finding on patients cancer to are Puma we’ll and tumors. more other the their achieve

presentation. This concludes today’s

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

Operator

proceed H.C. you. question White Thank first with comes question your your And from Wainwright. Please Instructions] with [Operator Ed

Ed White

Thanks afternoon. my questions. taking for Good Sorry.

gross Did XX in point just the quarter? a So I What was the net is clarification. something? to hear the first question

Maximo Nougues

to no million. second, a the $XX.X gross Give net was me

Ed White

thank in you programs increase million, an are in And participation? assistance patient seeing you. $XX.X great your increase

Alan Auerbach

additional So about and Ed, in nature? drug programs, terms for free talking that of or patient are about assistance you are talking things mentorship you of support

Ed White

free drug. No,

Alan Auerbach

closely. watching We in in QX. year did going true drug hold free an that where noncommercial last It’s trend increase see partial we’re very seeing an actually we been We’ve in that. did that QX, not drug in had for increase a not

Ed White

of - been your can China you, little clarity see lumpy just with but sort growth regarding give this royalties we the of are the a bit the should And Great. the I provide for more, there projections. the also, Okay. maybe partners numbers? of you sales - Thanks. doing year? know to a over U.S. on little always smooth us COVID end what bit And outside boost you of has sort

Alan Auerbach

answer the We the payments because fact terms that of they that in been with also lot of of the market. as then the of sell you’re that it sell and lumpy. partners lumpiness of various absolutely is that to lumpiness Yes. well. get manufacturing is we It has specifically, And it China a then drug Ed our amounts. correct. of do and question, of for to manufacture it them lot the A China, to

So can and it and the over that. takes things and transfer like when we things time

lumpiness. kind To are that still countries country, terms our question gotten answer every And lot So for to situations of that contributes what us. that your them, different. second haven’t a of there’s of it’s U.S. partners we in they doing, where are reimbursement ex in

doing voice for increase their we’re in boost. in physicians. the U.S., provide all and with continue that of is them, interactions the see additional So having more to we which will same share some them trying But and waiting doing thing that, of we’re to the

Ed White

in that the like the effort running the to dose? also on patients increase number programs lower they you an are - start to And did of

Alan Auerbach

we in not have the countries, on yet others, it’s dose approved some in lower And label. do

try effects. a from it’s and as the a not of to to efforts we do reduce think portion side So other there yet, I promotional some countries, label educational that others perspective. dosing the mix In any appropriate have there’s, around of

Ed White

And seems just Okay. of year. question Thanks. of subject on last Are It at last from down first the lower the dose. first starts my quarter the sort is of was quarter increase will the you think do at there is start? can at right plateau you dose do something to or is that the that patients be a now this level lower that you

Alan Auerbach

that question. dose we’re room does tolerability I’ll some Yes. that to and very going the that’s see, saying, but give of it going it. still we Great think obviously, I continue have And profile. I’m an little important low change not to estimate. And that drive a that as far max I bit as couple appreciate I we keep that you explain factors going guess off the to to more. we’re further penetrate, would of a on too here. There’s, we

treat. are clinicians Number folks one, the is metastatic, - dose full are setting there metastatic efficacy some to in start want metastatic of which on small but setting, urgency business, part that to as there I the reasons for mentioned, our a that into just in

We several starting physicians clinicians comfortable that also in a full very adjuvant a or have of are the on group extended dose.

has goes one my patient sure that starting But you to majority channel. other opposed I XX% to a with about other reduce moving as articulate as vast our want piece the now dose are direction. side through saw they on and important, of opening if in going make that challenges to low dose again that I effects diarrhea, think is And I the SD business want is, The and/or the up.

seen dispensing So channel. the in in-office we’ve growth some

stays SD channel, if in is. that this in we do know information. is SD what channel the not important that’s won’t reason patient-specific The their the starts dosing patient and a We get context in

the strong. we patient What portion, community a come those get They enrollment of believe, SD escalation, start uncommon We we enrollments. side that the setting not an in to pretty will collect from also the don’t is SP is the in won’t adoption dose over where patients. is

prescription in If that the business right? or first because XXX, come they after second fill, our low move and them on at portion payer full third second fill the SD dose. pharmacy They forces on of in will or to start a start specialty a their specialty session will be and dose pharmacy at to the

capture as would don’t And as that and so we clearly we -- like.

you to Hopefully, So the makes actual the are numbers of quote from we is. what execution low believe dose some sense. understated that I

Ed White

a lot Thanks clarity. does. It for the

Operator

The Cowen. of Divya next the with with TD proceed question. question Please comes your Rao line from

Divya Rao

in gross Divya the Hi. question. question guidance. to net line Thanks taking on the on our Mark. with for it follow up the To full for like looks for year keep

to to to second I have - a XX%. think net. used be in decrease do follow-up I guess gross And then a assumptions gross that that? half net making around kind what you’re lead of what you are The that the significant would

Maximo Nougues

Yes.

So price is data, you’re about half. What of we of for we’re the net, offsetting right, gross what that’s that inflation expect terms of we is right, the some that some back in the seeing had. increases

changes. any and and you than that don’t net of usually that, highest in so QX terms quarter to other the to So [inaudible] for we significant really remember gross co-pay plan due is Again, need on.

Divya Rao

guys That’s guys potentially helpful. moving And could lung you would do forward a haven’t cancer? think FDA then, run then cell program. would the to But a internally, switching conversation of small I a FDA are had that the trial? or you with that single-arm any that you forward you trial in design I realize to alisertib require guys there maybe you alisertib with randomized criteria reconsider you And with think do gears guess, go yet. expect the kind

Alan Auerbach

I and question understand so your repeat last you can the clarify just part, little a Divya - that bit?

Divya Rao

the might require there you Yes. any design just that run was you anything a forward if cash just maybe like guys capital in on FDA that either constraints I move that based to was you or might conservation trial might reconsider or that criteria of and reconsider moving? for asking

Alan Auerbach

Yes. Yes.

Okay.

for would - a which trial, single-arm we for is your combination the which a path allow or or market the with approval to alisertib, first both. of FDA. do the accelerated the terms trial part in of having think of the is question, your reason meeting an all, of randomized first That’s So a

one sort have in history you of for trials regulatory based at approving them on there on single-arm example, is looking that the that lung small Now of drugs indication. cell a ledger, cancer,

So regulatory there. you do a have precedent

you side recent the having for from On the discussion which of trials. the and toward ledger, been That’s more from obviously FDA, come reason them. leaning has the away have with out randomized single-arm other trials the the guidance that’s

on whether I That’s or small So whether lung we single whether with say, or that’s monotherapy to -- cancer have should a randomized. what to discussion it’s trial, it’s them. another trial, biomarker-focused population we entire want it’s with cell the a discuss one want them, a is in

To your last question, which is, is forward. there any take design not that due to cash reasons we would

said As make are earnings flow the we and we have income for in thing of is every company that important calls, most our one this sure cash positive. to net positive

as and conference, conserve So income Mark your cash protect at me stagger indications to you well, able which think I that to question the the had asked be would net was guys’ line?

in positive, will and earnings every it one and cash there’s this achieve if that. and question cash said that in net positive, of the no company our positive I flow that. we have our need we for budget and positive income will is the income and we continue we be important continue be to to to be breast lung order need we said, flow thing to calls, do R&D stagger Absolutely, net to manage the most such can indications, Like

Divya Rao

you. very it, helpful. Thank Got that’s

Operator

from comes with line Please with question next Our Bank of proceed of Geoff America. your Meacham the question.

Unidentified Analyst

question. the Hao for Thank you is This on Meacham. for Geoff

growth indicated QX in of the while guidance, strong your to year-by-year year-over-year, quarter-by-quarter XQ decline question product the pretty was a it and on net terms product of revenue. net seems terms in just so new And be patient

that understand to bit wanted on there? little guidance a just the I going So XQ more into assumptions

Alan Auerbach

time, repeat more you question one can sorry, I’m your please?

Unidentified Analyst

Yes.

guidance XQ to in had seems while the of product about strong revenue be year-over-year. is second $XX question million million quarter pretty revenue decline, my So to terms you of year-over-year growth $XX a net a XQ

growth. was also New XX% enrollment patient quarter-by-quarter

So guide? the that just goes into assumption product XQ understand wanted revenue to net

Alan Auerbach

Yes.

Okay.

XXXX roughly you to thank that. there QX for build of clarifying have to remember Comparing in an XXX inventory was to QX of XXX So you XXXX, that QX XXXX bottles.

to comparison you’re that’s that doing. going offset So revenue that

Unidentified Analyst

that’s Awesome you. helpful. Thank

Operator

line question Barclays. with with next your proceed from the Wang Our is Gena of question. Please

Unidentified Analyst

Thank big SUMMIT Good discontinuation question. of on you, last neratinib for picture a question This you study. taking Harshita our is announced quarter, for Gena. evening. Hi. Perhaps for the Alan for you so

our is outside on in should neratinib [ph]? of neratinib terms growth what opportunities the while be of already approved value alisertib going revenue on expansion or thinking provides terms in indications now focus So of floor opportunities forward primarily

the additional that, heels your you’re it products pipeline? like to opportunities could in-license are like complement cancer of it? about on other little on you And primarily a if would that Is you expand thinking in that be Thank exploring you color on more how Any would helpful?

Alan Auerbach

Thank question. for Yes. you the

expires to not the you’re neratinib, correct And with regard XXXX. take on in So for SUMMIT NERLYNX forward. the we decided that main neratinib indications our reason December that to is that competition matter patent

or or screen in these run ROI the for XXXX cost, just which that you’re XXXX. where to patients, time to go something, approved to through additional randomized positive very us rare for can you and in us trials do the mutations add which go the So time trials by and again, do wasn’t five-year

not and investors very just that. protect for the get ROI. return on their protect the And for important to to You’re again, it’s investment going us

metastatic So not the cancer growth HERX-negative two cancer which lung execution breast you’re continued cancer. main correct settings. to HR-positive chose we have indications for extended that that we go metastatic and the cell be with, neratinib, in the forward will small for Obviously, adjuvant and is both to breast take alisertib, And forward. the

to And are we continuing license. assets at then other in look

maintain is company I First as positive to positive. continuing to of to most all, cash and thing flow the mentioned at the important net the prior us question, income

and to knowledge those domain X and look with what we things, would flow income Cancer cash obviously It’s a is. again, know. else what we of So bring our positive. anything net protection is positive in

commercial think we go develop Would We that? and in infrastructure to of it. it commercialize look to -- so. really assessment existing oncology. of now, and I of we to It just skill right the don’t set outside have don’t wouldn’t doesn’t it able specifically. It possess right outside an the oncology be do

some prostate things there’s for different field and urology where realize you instance, go and something I like that. a like or into cancers, it’s

strictly have You breast with cancer. don’t that setting. an just oncology It’s really

what So We the would that... really oncology something sense is in look a make the complement from most perspective outside wouldn’t space.

Operator

Thank you.

final Mayank the Mamtani proceed line with question. Please from B. your with is Our Riley of question Securities.

Unidentified Analyst

taking Hi. This for on again Yes. is William actually our Mayank. Congratulations for thanks and questions.

realize over a been So bit. little financials the I have picked

later your this actually a of was I couple So with reporting data trials curious about year.

more data upcoming Just be curious Phase And - that of bit breast coming potentially and behind in year? that trial sort also Thanks. up and be get might we same your biomarker little I/II this where the on investigator-sponsored a the we idea HERX-negative expecting expecting color then then the also. if we then should cancer could

Alan Auerbach

you question. the Thank for

cancer, it cancer. triple-negative alisertib cancer and trial the HERX-negative breast previously cancer. efficacy a specifically survival So tested showed a and trial benefits. -- in it of in breast alone. was a trial HERX-negative progression-free the HR-positive plus breast In against the And in paclitaxel patients patients was both alisertib in with breast and was It both, HR-positive, paclitaxel in showed

More kinase ASCO there’s an an could that June. and pathways in that we’re a be with at poster alisertib, of is inhibitor inhibited on would doing aurora looking Annual inhibitor. presented interested be analysis specifically, in that, kinase by one the what as They’re a at will lot biomarker anticipate like aurora a Meeting

cell our the mutations biomarker showing small in cancer or efficacy amplifications or with greater in published, RBX patients that there So lung for CMIC RBX deletions. was data with trial example, was

that would would So much interested perspective, would benefits, seeing well. with think more obviously an from enriching magnitude which that that active, what population in we’d very be one a alisertib we certain biomarker get a suggest R&D would us would potentially be the where greater you of a is be better the by to as be commercial anything obviously but

from trial. So really be would looking data that’s the we for that

for yet think that and chosen enrolling. the RBX second probably head that of trial, plus On neck your cancer be which the we’ve second we that. half year alisertib this that is question, present still would assumption My sometime. I deficient conference in is pembrolizumab don’t would

let once will we we do, So investors know. definitely

Unidentified Analyst

-- Awesome again. that, really thanks appreciate and

Operator

back question-and-answer would Thank like conference I turn for remarks. you. closing our This Mariann the to to concludes session.

Mariann Ohanesian

you for us Thank joining today. all

this may today. at a good the of evening. later beginning a replay via reminder, call webcast As accessed Have be pumabiotechnology.com

Operator

This Ladies great Everyone, conference and a in gentlemen, day. our for concludes thank program. have today’s you call. participating

now may You disconnect.

Puma Biotechnology (PBYI) 4 May 232023 Q1 Earnings call transcript