PBYI - Earnings call transcript Q4 2020 | Puma Biotechnology, Inc.

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Operator

Good afternoon. My name is Dona, and I’ll be your conference operator today. Welcome to the Puma Biotechnology conference call. At this time, all participants are in a listen-only mode. After the speakers’ formal remarks, there will be a question-and-answer session. a conference as being And Instructions] reminder, is this recorded. [Operator the now to like would conference to I turn over Ms. Mariann Ohanesian, Puma for Senior Director of IR Biotechnology. you. Thank ahead. go Please

Mariann Ohanesian

Thank of XXXX. Conference to Financial you, and for to Results Quarter discuss our Dona. Puma’s Fourth the afternoon, Good Call welcome

fourth Chairman the of Nougues, at quarter and Chief future be these The slides the refer Commercial and expectations, laws. Ludwig, today, the statements me financial available Financial a webcast differ pumabiotechnology.com. prospects presentation Puma company’s Officer, on release detailing slides forward-looking days. next Auerbach, via and website Officer. will issued news Executive Puma That are include Jeff that those Such Chief close website today Officer; results of archived call accessible our constitute plans, Joining for Board replay and After statements. the Investor Alan of are Chief President, of Maximo market to, Biotechnology; XXXX release, conference and homepage will to are news results. in a for and the and this expressed for the actual that uncertainties, about federal from Today’s XX statements call may and securities and forward-looking webcast of sections will subject risks purposes on statements call our Jeff

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

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

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

Alan Auerbach

in you, Mariann, Thank revenue you total joining well quarter from Today, million representing for million from of U.S. quarter and a sales of reported as sales, for fees and from XXXX net the fourth thank the XXXX, million. $XX.X call our decrease as XXXX, XXXX. all of revenue the reported royalty third increase sublicensees. $XX Net Puma fourth includes of were the NERLYNX of our Total today. million reported quarter sales in a QX $XX.X slight $XX.X NERLYNX in the net in

results royalty XXXX. million also Our $X.X in include revenue of fourth versus $XXX,XXX quarter QX of

Nougues will Maximo quarter with statements key of quarter a financial activities. the will provide components During follow XXXX, of fourth quarter NERLYNX XXXX. fourth on the our of Jeff and experience with the the continued we begin will to brought a of of of highlights details Ludwig on pandemic. I result highlights some the review of of COVID-XX challenges more then commercial as the for

also this publication were breast We will believe ExteNET cancer from increase Breast trial clinical NERLYNX the in announced for stage early of our in XXXX, the patient of meaningful the Phase there and early neratinib were clinical In that results its During that population. in of HERX investors. awareness that fourth quarter HR-positive efficacy positive, several updates we for Clinical journal benefit III this Cancer. company were October, published

tolerability of effects the ExteNET ways side to Breast of trial, improve at CONTROL which December. San drug reduce is ongoing and presented also the trial data the our the in the We updated investigating Cancer for NERLYNX Antonio from Symposium and

this of Once be would continuing timing Enrollment will this we patients in arm conditions arm completed XXXX. analysis would expanded enrollment of impacted responds, or have referred line aware, the enrollment trial neratinib during recent to trial be may mid-XXXX that would of The the to additional have of also fulvestrant in an are timing which the perform look or reach alone, either enrollment enroll for we will cancers, trial ER-positive and in Stage further HERX-mutated amended patients mutation respective arms less COVID-XX two-stage by Simon’s a cancer will patients. XXXX to is in QX be no data, obviously to the than is closed seven of in is basket the which certain dependent be top If the determine enrollment. this Puma XXXX, of patients, design expanded that a this between in described. in stage, weather If and parts investors be two-stage complete, plus plus of this the of randomized the were a seven arm was in on enrolled. HERX-negative not SUMMIT to plus be respond, X, Under ongoing given combination enrollment. arm that HERX the as or in to able late was breast the more trial. to will under or estimate than trastuzumab. patients arm trial would top such who being current XX early per The modified closed each As first We somewhere early one enrollment line to analysis whether patients more arm XXXX. U.S. our and initial patients in receive and four respond, and will has study trastuzumab, if further design, respond, patients expect The that initial patient up of given neratinib Simon’s fulvestrant arm expanded expand is will not If response the fulvestrant the arm previously arm in patients XX response. that whether a forward four the be the or patients will SUMMIT

As potential analysis to noted we would line anticipate for accelerated pre-NDA the basis FDA for the a that discuss further form the would we this approval. previously, with have meeting top

As EGFR cohort investors with who cell are factor on trial, inhibitor. by cancer also metastatic for the aware in cohort have an world in SUMMIT non-small from November, interim the patients we of another been of an XX Lung announced cohort cancer the from International with growth mutations lung kinase previously from treated this Cancer. In additional more epidermal or oral with lung Study excellent data presented the specifically late data and Association XXXX, patients at EGFR the conference presented tyrosine we January, discussion of

We enroll and report XXXX. half in the patients this to to second we cohort are that will have anticipate cohort continuing this additional of from of data

developments concluding patent, proceedings other treating EGFR Puma which we originally European at brought Moving granted. patent were that and licensed a cancer patent a in entity TXXXM EP covers Board decision issued fourth against decision announce was a of X cancer hearing to its on its and announced December Boehringer by to erlotinibresistant on final the the the that EGFR XXXX, initiated the the final European in thereby as Appeal gefitinib pleased with inhibitors use European inadmissible in irreversible quarter, and/or XXXXXXX, Ingelheim upholding patent appeal prevailed in of reversing the The opposition of opposition mutation.

achievements which include agreement the In close to Mainland Macau, of includes of the extend payments the that that after an regulatory existing as of payment NERLYNX addition, additional licensing Hong could upfront China, sales-based million. milestones have in under Greater on and today Puma China. milestone their regulatory be and Taiwan, terms million Fabre agreements an commercialization as based add Pierre receive for Fabre up the well Kong, and $XXX Puma These granting terms who announced will rights to Greater solely China, will additional $XX agreed to and Pierre to sales

the double-digit will Greater Puma addition, of NERLYNX tiered receive royalties in on China. sales In significant

commercialize agreed Puma. Greater Puma to Puma addition, Pharmaceuticals return a rights fee to NERLYNX in mutually has million back In all license $XX CANbridge of to in China. return CANbridge Greater agreed in one-time agreement – have to pay their China to terminate neratinib and to

China review year. anticipate the pleased of with in the make the one Jeff in patients cancer China NERLYNX to for Fabre of currently NERLYNX Greater call drug the into We region. quarter. Chief drugs plans the Pierre our in second quarter which Ludwig, China commercial chemotherapy vinorelbine, China, now extend to well-equipped markets of Fabre infrastructure available a to our to in Pierre in I make Puma’s is the performance to are Mainland breast as common is Officer, relationship Commercial will that the cancer with Pierre an existing in therefore China. commercial Navelbine We success breast of used Mainland also known turn treatment during over this Fabre and

Jeff Ludwig

treatment help market underpenetrated Thanks, stage with this promotional put NERLYNX of from our The becoming is forward. important early foundational with around can in customers must and it, We a that significantly preventing and I pleased play believe for breast the of our has execution adjuvant NERLYNX with our focus the done to goal to to and extended patients work earnings increasing families innovative reposition an to our the resources more are the focus organization and cancer. thanks Alan. Appreciate emphasis been an patients in and in call. their interactions joining commercial perception, with benefit but role be in on of and quarter and very with fourth manner. This work deploying place, everyone moving battle efficient goal metastatic breast cancer, hard strengthening metastatic. risk increasing is am continues the we

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

dispensing QX, channel the As our refer that have NERLYNX through as channel distributor our in-office may specialty provide of specialty majority patients. to we these our business channels pharmacy to two channel. you The specialty flowing flows of the This or and recall, We line with earnings in is we this channel, as during went call channel. specifically, with in through specialty the reported well. our XX% our XX% business approximately what distributor through QX More channel. pharmacy remaining

of Now NERLYNX I you provide quarterly U.S. net this financial the review since results, FDA U.S. will later will shows sales X now full Maximo but Slide results. approval. sales in with the current call,

XXXX. U.S. quarter our Alan sales This in the $XX of we $XX.X fourth million increase QX million of reported over were As the is a XXXX. slight net noted, in product

fourth As Thanksgiving, we Christmas, mentioned around year on and initiate to the prior new in therapies to the as new not tend earnings starts each in holidays. decide quarter some Year’s decline patients patients QX calls, New see a

be continue COVID-XX by impacted results to these the pandemic. addition, In

remained not levels are previously you seen see have As to likely to infection team promotional in with These with this our live the and increased that’s to and field pre-COVID hard and interactions caused increased our fourth very that rates the COVID-XX With decline. baseline. interactions begun said face-to-face challenges promotional adapt recently is below these working to spikes aware and customers significantly we overall The virtual have non-personal we continued have new norm. remain environment efforts. quarter interactions only

cause infections, disruption spikes these the likely the in we more is channel QX. along softening with pharmacy specialty some can the see QX stage addition, both early in distributor In this to specialty channel overall in cancer increase significant the COVID-XX in and these and a in setting. occur Combining breast did patient holidays flow

QX. launch. of NERLYNX commercial XXXX, We bottle in organization our focus of bottles the shows by NERLYNX. of a has elements decrease the sold in The X,XXX. that Now with that previously perception mentioned I the this since include work very of is With benefit sold from X,XXX slight is happen been of not the to NERLYNX put place QX did sales which risk bottles XXXX quarter to happy QX strategy following. some of that I in said, Slide foundational which am NERLYNX of quarter-over-quarter, grow the change Key X,

that results incidence grade the antidiarrheal important strategies, the X NERLYNX. and of the September of escalation of of improve including study was of dose it Oncology. control significantly of reduce in This highlighted can edition diarrhea because the overall Annals tolerability First, interim the publication

in the the patients within from HR-positive can broader one Clinical year increase the play second were during NERLYNX representation XX% this believe The benefit highlighted a the XX% risk of to of benefits San We because seen and Slide significant supporting QX, efficacy in expanded in be Symposium poster trastuzumab-based all recurrence. trial edition an of the We a opportunity that Cancer. October This was of disease an early the at even combined of element in patients initiated therapy. that it’s in good spotlight demonstrated the HERX-positive the risk the high that of December dose QX. was accepted NERLYNX perception consistent of with An the important changing can invasive following patients Cancer ExteNET in XX analysis forward. heightened residual control were publication descriptive of on it important in descriptive role extended the of remains impact reported And profile their shows Antonio’s play finally posters, risk in seen poster results key NERLYNX reduced publication additional a a analysis These is data information going with we survival, role escalation at disease-free control overall disease benefits an X, the final important benefit Breast NERLYNX and initiatives group. This from a approximately that on highlighting with CNS but this Breast new dose. ExteNET believe This study. the over adjuvant the events. survival starts indicator setting, there note of can including of which receiving OS

breast since escalation reminder, We X with in setting, the a diarrhea, very a adoption than with to in of in highlights will Finland the NERLYNX available the days with approximate in X of in well strategy overall data QX, NERLYNX collaborations dose coupled NERLYNX in As that Slide PRM reduction more grade median in average the battling greater end showed dose length goal important XX% believe improve XXXX. cancer. the increase XX% an patients globe reduction Argentina this that escalation of the tolerability around in increasing diarrhea a the the loperamide, that extended therapy the showed most utilizing world. highlights the benefiting adjutant result, XX% cumulative strategic a have is X, Switzerland, formed of and of and reduction patients discontinuation. of include we grade the incurred Key the approval more and control of as metastatic making as launch recent January across

Macau. in his Taiwan, China, have our In addition, Pierre greater as will to mainland China, highlighted Hong opening with include Kong we remarks, Alan partnership which Fabre and extended now

Europe, the to team impact of the the breast well We the In on to in closely our patients and been with HERX-positive battling Maximo? review by additional our foundational done work Middle approved and are now I Asia to the partners continuing Latin to results. forward work for has NERLYNX look potential turn summary, that call believe we Maximo in America, the be countries for of will increase East. I’m that a positioned having cancer. over the are are proud financial and we

Maximo Nougues

will brief The a begin early that as XXXX, our results XXXX. I and company which than will Jeff. statements. comparisons that we better of you make recommend summary year-over-year financial commercial quarter will note of a information fourth Please I and QX the are QX comparisons. believe financial includes for our with Thanks, our be which more March our progress filed XX-K, to of I refer consolidated in indications to

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

the XXXX. sales QX. $X.XX XXXX NERLYNX in million $XX.X per $X.X we $XX.X was is revenue reported impact loss million Gross On fourth the QX for net stock-based $XX.X share basis, net XXXX non-GAAP loss of and Our million million income was a QX adjusted XXXX GAAP million. quarter compensation, GAAP in for QX to net which was of remove versus or for our of $X.X a from

slight NERLYNX million $XX.X In in we As net our of Alan revenue XXXX. in sales the from million was million net $XX third QX. in million, mentioned it, revenue a $X.X versus from QX partners of recognize $X.X from also increase sales royalty global XXXX, quarter

in net for was our intangible million. license XX.X%, to $X gross which increase an sales of neratinib of million, driven from to Our rebates, was gross-to-net the related mostly XX.X% in about Cost increase included amortization by QX. to was The cost approximately adjustment fourth $XX.X higher quarter August. of our the of in price increase the due adjustment QX assets

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

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

in revenue and world the net between $XX $XX in there of the new gross million. impact for Historically, year ourselves the to lowest our million also quarter sales $XX is a QX. NERLYNX uncertainty regarding the quarter segment this And that be fiscal to license holidays disruptions year, We patients, conditions of factors, around number range to million starting range impact XX.X% to a carries parts enrollment. revenue. first partners will which [indiscernible] product Furthermore, fourth royalties XXXX prior and U.S. recognize represents of quarter to $XX great the in year, XXXX, and to recent the of royalties deal may negatively in including over and license the anticipate weather of the during a our in due anticipate decline We in we some to Also of potential receiving in net the XX.X%. million from our COVID-XX. of adjustment the created continue the of the certain

million. QX approximately $XX.X were the compared $XX of the million. million and be anticipate will million we Also, We quarter $X for of in NERLYNX SG&A the million will million $XX.X respectively. of XXXX, to QX R&D compensation stock-based million. for compared $X.X million XXXX and are the for QX and million compared $XX.X for that and In million Pfizer $XX.X in and $XX.X QX expenses QX range revenues expenses that net the expenses $XX compared $X.X closely. and for non-cash revenue $X burn to be QX payment of to the the tracking in And fourth for of to a development gross quarter QX million in expenses, XXXX non-cash reported will of which included including in million, fourth $XX million to of million $X.X million will respectively. respectively. million SG&A We $X.X million be range $XX.X Royalty of and for and XXXX in $XX.X million the XXXX million XXXX $X.X XX%. XX% fourth milestone charges QX million sales to cash recovery Research a and were $X.X in be Puma anticipate net charges XXXX, $X.X quarter QX QX. stock-based $XX.X million in license XXXX compensation earned of fourth include cash compared to QX XXXX. quarter for QX to QX to to $X.X

fiscal our burn included full the We $XX.X million equivalent, of neratinib. cash, licensor marketable $XX.X the ended year, quarter For in was $XX.X the which and million with XXXX of to of cash cash fourth payment million, securities.

Our accounts at $XX.X was receivables balance XX million. December

and three clinical on days. through trials estimate their financial network of our resources are our of approximately our neratinib on year-end distribution and receivables outstanding Overall, weeks the days about while deploy We to commercialization XX balances focus accounts that as Our XX range NERLYNX. to maintained of days, terms continue inventory. XX we ongoing between sales XXXX,

Alan Auerbach

Maximo. Thanks,

XXXX to that that Directors, Puma’s remain the with us recognize challenges pandemic revenue management NERLYNX we is of achieving and in beyond. to Board growth. and the cooperation growth that to focused continues sales improve senior respect and growth to to need NERLYNX sales continue We with presenting on in COVID-XX

this during pivot a for goal. growth. will environment due strive committed journey, to virtual look a their pandemic, sales needed of forward need these are that at the that we adapt to We This positive we and NERLYNX make are and finding to infrastructure will to effective patients the presentation. achieve contribution in to COVID-XX unmet the our are cancer. continues concludes passionate breast Puma updating to to hopeful helping to more be significant about changes continuing that toward investors future. to have women we There commercial continue on to and We battling today’s ways We

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

Operator

floor go first Our Kennen of is for Ladies and Markets. Instructions] MacKay [Operator now Please from is RBC the gentlemen, question open questions. today ahead. Capital coming

Kennen MacKay

on the sales wondering for it off, their Maybe then next the I’m in as to steps beyond and relates that, first thanks of litigation Hi, ongoing taking sort question. the TXXXM NERLYNX. question. on twofold of EU, IP on

the has been wondering with again, from metastatic to reps HERX-positive what the Thank in space around Just competition you. setting. tie feedback setting, metastatic then

Alan Auerbach

Kennen. you Thank the question, for

matter. can with regard patent, sensitive sure to So one topic I’m a TXXXM you our that’s imagine is that legal very

take there’s common not second that your And to regard it. if metastatic like on so provide question Jeff, the you’d we with that. therefore much And to can

Jeff Ludwig

to. Sure. Happy

So as mentioned setting excited I the metastatic Kennen, February. was in in remarks, in approved the that we’re opening NERLYNX

honestly, to very mentioned and was And you December. good. approved agent another we thereafter April, As quite late Kaiser soon in in approved was feel

good very more where the in patients many that’s setting, So metastatic options. there’s for

how sequencing metastatic. do we seen We’re In setting, is do but the to same the we in see some type focus competitive agents still we significantly market I of to under-penetrated. patients plays really to expect patients’ environment prevent the can we tell watching setting, to that extended adjuvant as progress, sequencing that from becoming metastatic can out, believe of trying unfortunately our and extended you everything is not adjuvant but in that see

is So of really therapy. our earlier lines focus in the

Alan Auerbach

And add kind setting, line four Look, can timeframe. and metastatic within in been XXXX approved especially, third that I of to drugs Kennen, beyond, there’s the that.

as Margenza. then an and extremely a Jeff from to commercial And You that’s had area. HERX competitive standpoint, said, Kaiser, NERLYNX

where the there very tends the maintain only have majority approved that on is much for wiser us focus. is for the extended it’s to us of competition no our large we be So drug our to where focus where adjuvant,

Mariann Ohanesian

your questions? answer Does that

Kennen MacKay

Yes. Thank very you much.

Operator

Thank you.

of Atkins from Please ahead. Kenneth coming is Cowen. question next Our go

Kenneth Atkins

Thanks my question. for Hi, taking guys.

think in profile there bar forward half, As successful? cancer? could you what do you the the achieve to lung be EGFR in second exon update you to us What need successes you we to remind XX for the look think

Alan Auerbach

Hi. if Thanks is the the you bar what that good I to will. don’t That for be to answer a question. question. is know quote successful

XX focusing a showed to who’ve been and that with data would kind are exon until The who roughly where showed data But those favorably is. So afatinib, patients as perspective, using that be standpoint specifically think afatinib. which EGFR of already mutation regulatory comp, EGFR treated I as rate. if that’s We compares had will, interim I bar on with a in using response Obviously, the from very can’t actually data that with the our an have from that response think that XX%-ish We space answer the that’s there an very, data you TKI. a rates a our with only discussion out a a bar – XX% we’ve them.

niche you the I think one best and is comp for parameter data, you. the the if give that’s I that I best give can can that’s the will, only there out afatinib

Kenneth Atkins

it. Got

one kind the through XXXX, are guidance on what year. for the what should then trends assumptions guidance, terms And we about of into happens think pandemic. in in built NERLYNX Okay. the And how just that the sales question with of

Alan Auerbach

that. like you’d take Jeff,

Jeff Ludwig

second We offices a believe very a are half believe NERLYNX, for to we vaccinated we of and focused guidance a folks of COVID bit ultimately, lot happening of standpoint, NERLYNX XXXX from terms latter commercial promotional the here. very In product. we about aware half open And this And the came sensitive of have pandemic, that than are see, a on resume out is obviously, get ultimately promotionally commercial hopefully, of in to good thinking half travel first different normal the the the U.S., data what’s on XXXX be will beginning you’re especially, obviously in XXXX. more of fashion. up, as perspective to little start very from begin wood knock some we

should promotional open us growth channels forward. having build those allow so more for moving to activity And quarter-over-quarter up

Kenneth Atkins

Okay. That’s Thank you. helpful.

Operator

[Operator you. Thank Instructions]

go Our J.P. next ahead. question from coming of Kasimov Please is Cory Morgan.

Turner Kufe

Hey, question. Cory. this is my Turner Thanks for for taking on

need accelerated pre-NDA So talked positive to just cohort the achieve Can year. later hormone it you pure approval what HERX-mutant show to breast data in do and you discuss think sounds pushes the trial you with to the cancer the just accelerated the approval. pulls this receptor meeting And SUMMIT occur it? of getting like of about of perhaps

Alan Auerbach

clarify, to HERX-mutant breast, the correct? just talking Yes, about you’re

Turner Kufe

Yes, correct? Yes.

Alan Auerbach

Yes.

Okay.

if don’t you going as explanation we When So I’m SUMMIT study. of agent a neratinib first mind, the kind started a were that in with to we single here. trial, treating long-winded

estrogen and neratinib inhibit And quite receptor we HERX who treated the mutation, them patients were of finding upregulated had these duration getting transcription gave were So neratinib, and pre HERX-negative at to a responses, ER-positive looking high. found the was We was short. post-treatment you mutation. biopsies, with the but were we was very what were we when that

the was clear of mechanism So receptor. that the was there it estrogen escape what

we so hitting So neratinib the mutation and estrogen the with fulvestrant, then combining HERX that with move we’re forward hitting receptor.

nine, we we although The of rate. with were hitting negative. was were kind the XX receptor longer hitting again response upregulating tumor mutation we mechanism it months directions duration did looking biopsies were post-treatment of estrogen pre that, was, We and We’re getting and receptor. and the a HERX escape found getting higher was of of we wasn’t, We response, it and types but the HERX for. were a

it’s HERX-positive. from being HERX-negative So flipping to

that We to – That’s us try asked that And neratinib we a out, – was discuss one meetings us and become fulvestrant contribution gave was other. path which the arm looking the triplet they FDA have getting estrogen the durations. where Herceptin to drug then is the more or targeted was forward. Herceptin Herceptin and in triplets. you we to what to went had to to other, do with I’m the and of HERX-positive. fulvestrant we the even effectively when started we to tumor much receptor, if the lot to where very getting would It’s of treat prevent was gave in going they needed fulvestrant involving them the to acknowledged that science And clear it the What was they they a over a well the thought try to smaller what advantage companies, fulvestrant isolate had we longer to that others, neratinib triplet to triplet see, meeting hit higher which the on to with We acknowledged than FDA trastuzumab go populations then of some mutation. be mean kind that’s alone rates, one tumor. of were in, what came the from treat to two-stage hit to the the assignment response the to neratinib So the for. trying you data. hope really see see in I will you in hopeful depend to that the

Now obviously approval the But a hopeful and like body accelerated we significant have FDA triplet exactly that on on fulvestrant, would of separation filing. you form of the see neratinib would data that’s very if large the we’re answered. a very basis obviously Herceptin clean that an question

what doing. that any be you do, us or are say can we So that’s that I to metrics of to they’ve give is asked numbers. kind I what All can’t appears

And so after data we FDA. will with had and we’ve more the know the seen discussion

Turner Kufe

That’s it. Thanks. helpful. Got

Operator

Thank you.

of America. next is of coming question Meacham ahead. from go Please Bank Our Jeff

Alec Stranahan

taking questions. our on for this Thanks Hey Jeff. guys, is for Alec

think touched you’ve prior you neratinib what go-to-market on this And with markets partner. Fabre geographies, additional bit, commitment U.S. versus is your And in view Jeff these little sense seen that do neratinib to the additional over how the for partnership and Thanks. as whether could Pierre Asia, guess in XXXX. to in versus your market what on guess to expect secondly, strategy these geographies what be I in we your will in new your but Pierre course I related partnerships pushing I announced of Fabre’s a the

Alan Auerbach

Okay.

in Europe, has partner expanded has Their us. they’ve So wants great to talk Europe. this countries some And addition partnership Fabre second us We it. excellent execution to a other about include Pierre a expansion the of to been been in to and the partner is been Europe. wonderful in

the that’s vinorelbine, fact is One of breast selling the attractive chemotherapy of things Navelbine, used drug main drugs have been in one about is very cancer. which they the that is them the which

cancer So there breast in their territories. that’s existing place to in an channel is physicians

in – commercial a area. been of months. drug In and par with in few their It’s China, very the quarter, terms large the in the to people companies on we’re in infrastructure have a there. already other training in so they’ve second scheduled trained they’re launch They the China

of So we optimistic it. have a very view

probably it a would U.S. say second I the In place. between the China. the and the for And be behind And actual in close may probably terms biggest amounts, drug. is Europe China actually second. dollar say market is that that Europe of I would is tie

a it’s significant to think forward And very I us. there. be going opportunity launch So for to their we’re looking

Now across Jeff in other as slide, got much on terms Board. partnerships of territories, in his the over went your question we’ve pretty

is East, which we ones, but Northwest there, South out countries more main Africa, Africa, few a Canada, there’s the Middle with Europe, America, obviously the Israel, those. partnered now all Australia Latin think I

main large is a that as partnered still haven’t I I country few there’s So the think think we Japan. well. And ones smaller we’ve got, then

Alec Stranahan

great. right, Thanks. All

Operator

you. Thank

Goldman Paul Please Choi question with Our from is ahead. next coming go Sachs.

Charles Ferranti

Hi everyone, Charlie for the This on updates. is for you Paul. thank

regimen uptake results continue of you study this dose that so of dose publication So promote Thank study, is that patients we’re It’s to there. NERLYNX to the the this a I’ve in titration of just sort addition see done done with from just what’s being question. or uptake much. patients in control the QX regimen to titration terms increase the you to just being wondering, got of making sure increase great I’m that showed wondering uptake. quick what of control expanding the

Jeff Ludwig

Yes, appreciate a it. Very is foundational good question. part We believe that of our strategy. important very

As we benefit a dose of operationalizing profile dose of embedding can the or and change tolerability. believe risk the escalation –

the commercially message clearly control directly, highlight benefits of for is a So as to non-personal significant field promotion the study. force both the as well

we’re is escalation a supports the size six month a first size we with two obviously approval then supports and week, submitted are for extended four patients for study update, forward. bottle adjuvant have XXX adoption have well pathways of forward also to of many bottle size. moving working the a that count of remaining that coming control the the piece dose weeks. of And the That That guidelines for actually embedded FDA there of standard We ensure that received new this is as per care the for pills potential to One bottle the and we committees pills therapy. as label per becomes the for part three pills with well. other update as label week,

embed it to launched as that So further be escalation. future in also foreseeable dose the will well

Charles Ferranti

All right, you Thank great. so color. much. That’s excellent

Operator

Thank you.

of Our next from go coming Gena is Wang question Please Barclays. ahead.

Unidentified Analyst

Sheldon questions. is all for this on the for Gena. taking Hi, Thanks

for adjuvant of from on that and The going – on, of cell idea majority breakdowns you current adjuvant? setting do And Can comment on we current extended expectation these already? evolution testing lung will in your testing metastatic bundled – genetic the EGFR this EGFR it your you versus Is second from XX extended vast do first about non-small breakdown forward. any assume is specific cancer penetration also the come revenue the the about these the exon could breakdown mutated mutations? have

Alan Auerbach

On you’d Jeff, that. your question to like first handle Okay.

Jeff Ludwig

Yes.

Alan Auerbach

the adjuvant. breakdown are believe of extended metastatic you is I asking versus

Jeff Ludwig

at about the will And starts are Yes, of we currently patients our for least that the setting. estimate a saying fourth several suggest metastatic expectation breakout consistent be or quarter would the quarters. that you’re in X% next new I

And on helping of can breast being we goal think As focus before, a hopefully or treated where recurrence are stage cancer, make is there. adjuvant patient’s them really bigger in setting. a heavily lives early our there’s preventing we I the awful not of that and the metastatic impact an the with patients them extended mentioned prevent lot on in

Alan Auerbach

And on that is mutation it’s mutation on to EGFR I already every XX and XX, everybody about cancer, is exon then guess good the your venture screening. much in patients exon they’re very that second question, runs. for the which EGFR the would done panel doing pretty on lung lung cancer

It’s on existing no there’s has anyone run. up test to being special panels. the So that picked

Unidentified Analyst

helpful. very Thank you That’s much. so

Operator

Mariann At for to turn time, closing you. the like over comments. I’d Thank back floor to this

Mariann Ohanesian

for interest Puma you in Biotechnology. your Thank

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

Operator

your participation and Ladies and Puma in gentlemen, for interest Biotechnology. thank you

lines at this time and wonderful disconnect You may day. a have your

Puma Biotechnology (PBYI) 26 Feb 212020 Q4 Earnings call transcript