PBYI - Earnings call transcript Q2 2018 | Puma Biotechnology, Inc.

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Operator

Ladies and gentlemen, good afternoon. My name is Adam, and I will be your conference call operator for 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. [Operator Instructions] As a reminder, this program is being recorded. to Director conference Biotechnology. of like Mariann over now Senior Ohanesian, IR would turn call the to I for Puma you. Thank

You program. may begin your

Mariann Ohanesian

Conference financial Adam. to quarter you, Good and to Thank afternoon, of XXXX. discuss for results Puma's our the second welcome Call

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

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

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

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

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

Alan Auerbach

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

or adopted Chief detail XXXX. NERLYNX known on our June commercial for marketing for Commercial Human Products Committee I authorization adjuvant quarter. Union, and been In will Commission, approve July, had review medicines decision million XXXX, the $XX that recommendation announced launch. stage of drug, the of for sales this net HERX-postive launch-related an Health therapy. a Puma's The stage NDS of in grow our by one following the breast million for adjuvant for a for breast for submission mandatory treatment adjuvant of with a Health we have new European the call Puma's patients Canada, We submission. to year reported Steve completion extended HERX-overexpressed/amplified approved adult of will authority and trastuzumab the the regulator steadily patients less and passed of the prior XXXX, Use, expect adult July for approved XXXX The forward drug of activities treatment NERLYNX U.S. trastuzumab-based the to-date. during as cancer have has and U.S. receptor hormone validation a will by health stage In Medicinal treated has increase to CHMP, recommending FDA with are $XX.X NERLYNX positive adjuvant progress the European also with opinion cancer, a cancer, NDS reported early which pleased NERLYNX, treatment that who federal be are of the in trastuzumab-based working we sales to to the in reviewed the country's over period Today the turn of early first represents the accepted the Officer, report In positive which CHMP breast to the with has entered the with of continued from NERLYNX review therapy. since We early who for for NERLYNX a review update regimen. from patients now quarter products quarter Canada was second HERX-overexpressed/amplified Canada the by period. first drugs our XX% moment, sequential Lo, containing in look previously sales who of the than Health for provide we extended

adjuvant extended cancer anticipate stage first in second for also breast of regulatory We countries of additional in of HERX-positive NERLYNX half XXXX approval and submitting indication half for the early the XXXX. a

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

aware, Phase are known also metastatic III of As trial we cancer, neratinib an as NALA the ongoing breast investors HERX-positive trial. have in third-line

As been previously in announced, has the the anticipated. rate coming in event than slower we trial

right trial current from XXXX. not This of the rate report to this is do event that to continued until that Assuming able quarter we in able the we event fourth expect that at seeing. now, the down from the event further, this rate be assumes slows data current the that trial even are report the If the be XXXX. rate continues not rate to data we until would it to rate at come

We updates. timing future with will in anticipated provide the continue investors to

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

Steven Lo

a Since momentum. continuing Alan. NERLYNX. good been has growth the had July XXXX. quarter have now NERLYNX thousands you, We Thank in patients steady been for U.S. market prescribed in another this forward FDA of since of approval to of our then, look and year

on physicians. our continued more reaching and the a are we we launch, patients of year As into execution be to focused

and key are patients more number reminder directed patients indicators on progress our performance patients the my at such, of keeping ensuring during As that the presentation, A statements. on will NERLYNX NERLYNX, primarily access, physicians. be I forward-looking of educating have making active

patients. pharmacies our the conduct prior directly As then of their insurance arrange company, NERLYNX specialty from to The six specialty investigations, network provide benefit patient home. obtain to a ship with and NERLYNX to recall, you may pharmacies authorization approval the

also the We pharmacy. physician's VA. also to to from where channel NERLYNX the patients have need be to a separate their helps not specialty specialty does obtain directly health and for the facilitate certain ability to the office, integrated systems This distribution sent prescription

patients Lynx you results, with will the support. review On Patient will with reimbursement financial since Puma call, full approval. quarterly net FDA Later financial our but and co-pay of Charles help provides now current sales slide sales offices Health Services the assistance addition, provide results. in the X, In I with physician and NERLYNX you see

XX% Slide NERLYNX shown growth discontinued the on aware along a includes increase and patients of through with number quarter shows patients Alan Note active total This NERLYNX. who number steady we This second in prescribers is that received the the specialty from through pharmacies becoming of million being NERLYNX specialty patients. month. each in who was and by month medication of staying the net NERLYNX increase completed both patients had of of prescribed mentioned, the NERLYNX of with another X an result the As quarter. at $XX.X more growth their and net received more of the distributors. of patients prior revenue patients quarter, the receiving active

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

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

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

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

minus here from updated have percent include the is is launched who prior from these since last completed precise. who active number on that chart NERLYNX has approximately As of their be patients in who patients to adverse number patients due Please I The have net patients and is of discontinued increased metrics the mentioned, of XX%. NERLYNX, we discontinued note or have the events are therapy. their will drug which the There slightly presentations. to we Therefore, do with therapy when Also, data of And lags quarter is some specialty the more differ our our currently we program, also XX of on at completed monthly update may we have prior patients the updated, NERLYNX. months a adjuvant free patients numbers pharmacies. X.X% months. numbers extended data year ago, Since now patients. the not

small there ago, a of our patients a treatment. patients and year As patients XX year. therefore you one complete discovered August of on are who who staying months can some on this slide, are NERLYNX their even total July beyond percentage that are last to due set NERLYNX the of see have started started we and In

to NERLYNX months. starting reasons, and the as are the been There in due There throughout personal vacation. occur even patients to such has summer patients of supporting travel choose frequently who number tell this NERLYNX delay during on we more We and month to NERLYNX a see a While NERLYNX a been of doctors also has fill hand small number as slide that see side consistent prescribed time growth bottom the market. to time saw been of company how off-label will shown payer On line of to coverage. contribute we steady and promote insurance this do that the smooth longer patients not to situations is the needs or who where encouraged you it patients days is the metastatic These right in use, small is slide. XX X, active continue receive forward. this we too to beyond or some are NERLYNX. it less, is, and to This year watch this and each continuing metric and see process which in prevalent these XX% we patients going patients in The a good days reimbursement XX early of continue or less more a sign the such information. as have receive continued for which on most market cancer, NERLYNX are

slide on force since Now, XXXX. NERLYNX that been prescribers only sales promoting our has actively on X. to September Recall of

We sales restrict access increasing their options. the now audience, Even awareness there continue to our increasing of still especially more target in physician progress make we opportunities though second to to quarter. management more physicians, XX% physicians in many are reaching to reps, believe reach diarrhea

see Moreover, launch incorporated X, AGO the and for the as pleased as and adjuvant NERLYNX the already a has United ASCO. on As guidelines are extended German St. that in you Gallen clinical slide the Europe, in prepare States guidelines. guidelines is been study, in such NERLYNX in we included in we NCCN

the in this prescribers not option treatment we more continues cancer NERLYNX brain has in its Overall, to NERLYNX in its as While breast physicians a metastases promote - NCCN number becoming their of guidelines. aware for brain include setting, cancer decided as of do increase. to patients are

launch we I As United outside are preparing the States. mentioned, for of

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

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

you As program managed recall, place access may for have patients in we United States. outside also the

providing America South China, Australia, to physicians for patients throughout committed Latin in world, NERLYNX and have We partnerships are and the established and Israel, to America. access

approvals with these will slide you the more timing our and payers our patients with XX% we We from reach XX, sales. a partners. key can continuing royalties partnerships. encouraged digit medication. on We're with throughout as receiving and expected highly are expect And and stay partners strong progress physicians, year significant regulatory of for be and be help next year. we receive with in approvals will see Puma made in We potential had to of globally double we each quarter their patients. To very the prescribers summarize, growth net a XXXX

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

Charles Eyler

Thanks, Steve.

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

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

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

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

Steve million Alan versus quarter. the from sales first and revenues million NERLYNX As net $XX.X mentioned, were for $XX

sales Our payments million, licensor million. approximately to of the the of $X.X of second cost amortization quarter includes for milestone the was which $X.X

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

NERLYNX NERLYNX patients for XX than us For This million mentioned that includes delayed recognized to $XXX majority range of summer currently be the anticipate number starting NERLYNX $XXX indication and year only. our presentation, on more revenue who adjuvant year. as guidance a to for in there a stay could needing Puma Steve XXXX, the who million. approved that months until the that fiscal after continues We to that patients guidance result his such revenues revenue net will in revise of from coming are extended of factors in the the

million on million $XX.X respectively. noted R&D impact million quantify million factors, quarter revenue revisions and compared XXXX quarter expenses for were As respectively. considering $XX.X our GAAP $XX.X GAAP QX on compared $XX.X million expenses too will Research the to next $XX.X quarter will million guidance. based XXXX. $XX.X SG&A and the QX QX compared early wait and to XXXX a of QX of quantitative to when were expenses before the these $XX.X during and for and approximately QX second we On the Non-GAAP should and and million it we be million the XXXX better making is of million idea basis, any $XX.X have were of for expenses for bit to to XXXX quarter. expenses $XX.X for a development respectively. related QX in XXXX impact until a of the review QX XXXX that incurred CHMP SG&A and million quarter million were second based second $XX.X second for the QX to $XX.X one-time It million million we XXXX XXXX for of XXXX compared $X.X to non-GAAP $XX.X

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

XXXX, with from such marketable net Our neutral burn excluding equivalents At of cash cash $XX million the in securities. of loan the about $XX.X loan for million burn reductions of the $XX.X to $XX cash million will to anticipate cash quarter We proceeds. term throughout for million - fourth QX second quarter that in and second approximately We for we the of approximately $X QX million operations XXXX respectively. cash positive. the our cash and our was XXXX second the quarter continued and have in quarter, includes burn by end and of This compared ended approximately $XX proceeds me. flow excuse transition cash XXXX flow XXXX million

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

Our loan, our $XXX $XXX sales existing we days days. XX our amended turns two Effective days days, term existing between accounts in amount subject a are loan and to million a term while receivable XXXX, tranches. loan range million funding outstanding the with of XX X, May new replacing XX

XXXX general received million balance corporate million original $XXX May was to the the of tranche gross of was purposes. loan first used outstanding on The $XX of retire for X, and and

and of May be of achievement subject of mature NERLYNX. XXXX. certain clinical to tranche Overall, we million milestones. will down second $XX The option our focus X, the The loan Puma's neratinib advancement drawn at deploy to to may on resources continued ongoing trials on the financial through commercialization of

Alan Auerbach

and from launched feedback have we receive we Steve. the for of quarter the breast treatment XXXX, to of and early Charles in prescribers patients, positive Since continued Thanks, payers. stage NERLYNX third HERX-positive cancer

We will our for and and commercial plan beyond. continue to XXXX balance presentation. expand activities today's of advance our the concludes with move forward to This

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

Operator

will the Thank Instructions] Kasimov conducting you. from we Q&A session. now line be question and Cory first Our Ladies [Operator our from gentlemen, comes JPMorgan. of

You are now live.

Cory Kasimov

for my the to of first afternoon, good you. taking I couple trend. Hey, questions. one, them about for guess monthly I guys. ask wanted A Thanks

provided afternoon also if net that's data the how in been you starts wondering also describe and encouraging. So, early April. previously monthly this could definitely helpful was that the disclosed monthly patient trending dip you new had and I you is since patient

Alan Auerbach

Yeah. thanks for the Cory, question.

that me. of in don't front data I So, have

you're on don't would I comment What discontinuations. is minus monthly say new is that really patients patients - plus So, seeing chart it. numbers basically I can't in the existing

Cory Kasimov

Okay.

Alan Auerbach

[ph] now. that's until So,

XXX with up XX. the add drug where month. so have specialty but just patients example, many could the from pharmacy, know a us One for that obviously, of And the how is did of to reasons giving you net lots hearing is you're only every a but were your sign what XXX are really metrics, want discontinue, taking patients is of lot we month investors, we a we

it's and who was patients and appropriate more felt to the new the specialty to to continuing which specialty helpful minus take includes will, every much basically and give we patients pharmacies more them it are if a more investors distributors. discontinuations Again, shows live model it both So, month. you plus drug the

Cory Kasimov

Okay.

even like mean been seeing the July quick, by what should like what be - signal. I looks acceleration numbers So, promising that the an slide went months looks over have in pretty what a but before

that you've question Okay. mean issues prescribers guess think one I said reached, is another might any of I XX% are stage, them detailed And or that this prescribers target that prescribing two lines? have keeping side does are I there then drug. or been at you that be had that they on the specific

Steven Lo

side This front Yeah. in target, And as been can effects. given that really in now that. the to diarrhea the talk which now. that answer I'll we've sales Those the is mentioned about. the Steve. audience, the oncology our lot foils of detailed. to discussions the And then versus which It's are XX% management will positive reps undertake, of see earlier, and don't we've physicians, same the rest, that is benefit managing is it been there physicians them we ultimately options physicians essentially I actually down of a

we and So, them conferences venues. access look in to other

Cory Kasimov

if one more slip [ph] And I Okay. could then in.

conservative quarter, specific you are Given this you if that prevents increase raising worried from guidance as sales at be in sequential issues might stay the fall that that? on be be we XX% is or about thinking just we should trying there I'm about to any the you head into anything point, curious this

Alan Auerbach

we're conservative on I trying to that, Cory. think stay

we we put I are But I and that's this a you year, on think revenue like we guidance. we guidance we earlier think more the think where were just more get, conservative, first lot will into mentioned, get metrics our know, as when - when looking little being changes we I Charles we bone of a comfortable. stated to before like we'd to meat the start that you quantitative is if any as there out to

Cory Kasimov

the Thanks Okay, perfect. taking for questions.

Alan Auerbach

Sure.

Operator

Thank you.

of Nochomovitz line comes from Citi. question the next Yigal Our from

live. now is line Your

Yigal Nochomovitz

on on for in of that how the you you any much split the program guys. working Alan, pharmacy receiving patients color the specialty office? Thank the very in-office have dispensing, Hi, the drug regard terms questions. is With in taking versus to do

Alan Auerbach

I any the as meaning dispensing. believe on the mentioned, from we and as month, receiving then they The about specialty Steve patients will that get the in-office we also, drug average. bars XX% is they high bounce the get are or it patients will forth, specialty from will - around of they the kind said the is through it error will that get get sometimes And the again, sometimes that dispensing. we Steve do XX% and sometimes an average in-office back and We've But seen who it the pharmacy of it given are where distributors, sometimes they that about get in go patients the from from XX%. week XX% as it's the get from pharmacy but in-office. which

Yigal Nochomovitz

that not in And reps, am plateaued XQ, on be then, sort just right, seeing that remaining reached great. of won't effort detailed you the XX% regarding there Okay, XX% prescribers front? detailing you are because of or the target hearing essentially eligible is the for they have you on being I

Steven Lo

necessarily. large which partnership those Steve. in has group to access of a Not to that physician I which think into with these now other purchasing large [ph] allowed Not there is Ion we've sites, more is process a organization groups. actually with we've working opportunities the we're entered Recently are access nice plateaued, us physicians. necessarily This

still not in look a is of us. lot have the I it, definitely So, at plateaued, there of but certainly front way opportunity

Yigal Nochomovitz

regimens get can practices those And any to been that of comfortable dose in effective the setting? just the have of also, of profile terms with thus the commercial far from drug? early diarrhea of some using patients And what prophylactic most you to speak are the types titration physicians

Alan Auerbach

Okay.

see is find one who just are the you of of give that the and just tend the for to to docs if think drug using common Colestipol management, I if So, and drugs And things ways. very of using to because having the to not that We via in and favorable tend is raise treating we do data in awareness other of terms because very that's been will. of many we largely and loperamide as feedback we have yet it's of cancer better diarrhea a label, raising preventing for not much awareness that group diarrhea our go success on you one his most them NERLYNX. need focused will rate so, kind the both see that Colestipol Steve

mentioned You and titration also the dose escalation. dose

low lung very of we and to full start a up diarrhea, afatinib terms successful in the what successful causing month where in in neratinib from of Grade physicians of cancer I is been lot dose We Ingelheim, think And aware With diarrhea doing a inhibitor another as very to to docs that get inhibitor. to give TKI. profile a for similar at titrate is just Gilotrif indeed X drug it titration dose pan-HER afatinib, is action this. and incidents they history have of There kind drug, docs over first are same little also an in that kinase all that it's exact the are of irreversible and this, away tyrosine doing which is mechanism then neratinib Boehringer oral which of is a approved the an called is that time. oral goes and neratinib with have cancer is afatinib has of lot irreversible sold it's A understand by in dose. the a then of lung been kind afatinib, pan-HER a

doctors We will isn't they so have are just don't aware, if something for it's cancer knowledge treat afatinib. you and community this have from this we recommend, we who of again a lot domain cancer, breast you market this, using lung

of indeed first much number better are where titrate doing this rate in success a of by the of apparently doing the who NERLYNX aware they're dose a having this. they and are We docs month

indeed prophylaxis, and or percent, trial, don't but as are this Phase well experience now the We studying to I better cohort of dose be this but much dose physicians using we it's which our escalation indeed a is, said is titration happening a have field. where how actually this is been lot looking a and in where able you in what control videos this II CONTROL docs have we'll post do and doing are our right at hopefully in from we have rate. about we're to that see where successful there online their know a aware online I'm feedback also talking we I'm know videos with having success these from there physicians know drugs trial as

Yigal Nochomovitz

Okay. Alan, you on regarding script flow by talk I the the mentioned about? EPS That's to basis, on then, helpful. in very fourth is And you cash about neutral think just an what financials, positive something being the quarter, can that

Alan Auerbach

about talk we I get can yet don't that. on profitable. think be we would when EPS We'll to need you back to

Yigal Nochomovitz

you. Thank Okay.

Operator

you. Thank

Lynch. Merrill from Huang Bank America from comes Ying of the question of next Our line

are live. now You

Ying Huang

in secondly, therapy will patients August Do to think start report seems little difficult roll for you the three it now Alan, drug? a get can just on adds. the slowdown if year, changing given bit about patient way Hey, to patient the know for might on talk the some new fourth it the if trends for XX I a then in even you net Maybe math last patients months terms treatment the you're months. of that's dynamic? last questions. taking And beyond see do you to quarter new they a my off potentially to be thanks of adds, the will the don't

Alan Auerbach

take the question, net a your plus the continuing graph we as number. answer comment, in are to who it's drug new you're the said that patients seeing again, Ying, So, minus first earlier patients to is discontinuations, basically

starts me, on this. patient new the I just you that have to don't graph. I again, so So, I comment in of can't will direct numbers front

number number therapy Steve which don't do make becoming be beyond are patients, graph, and we're therapy don't to mentioned having as In to of are yet period. we're that Again, or for with continuing. a patients drug of the seeing months patients patients you who who longer going said seeing very the who have already or have huge take one year, completing see the they become of continuing percent encouraged for can months terms a available have that of the But we year. they decision of either do huge the continue in a their patients available on of we XX very encouraged beyond discontinue, that, we're XX obviously of we're their

them comment, recurrence. desire is can something the really one is the they this continuing not like first patient's this And the everything that do seen. think prevent I been beyond has Steve, like to to you'd year to time if

Steven Lo

Yeah.

So, other addition Alan. I'll a comments in add to few

starts. So, When first in patient channel. on from new reported the also those pharmacy we that quarters, note was please only specialty prior the

So, our only number you that receive active us. of for We the patient on net specialty channel. is indicator new starts. portion distribution that's we And really information why patients key of the perspective, you don't from the performance a showing were the providing

this of treatment. were to can their which there drug When last occur. a they want a the who duration, have not indication a have on script, year, with reasons, was reached tell to to year used drug variety although Herceptin, the are for patients the on option essentially second, mentioned patients cohort the do On I who have of adjuvant after as go staying earlier their before a small a related one is I also an off I is year, work I you we recurrence can for on many did

year. we is think need this launch, patients the at may we more our reach I look we have to in again, as early see more clarity metrics, and one So,

Ying Huang

who may, it. on patients guys do cancer Thank percentage patients I are brain metastatic if about actually roughly other idea off-label, the breast Got either patients? NERLYNX or you of met any you. have And

Steven Lo

data receive did that. about I the We noticing understand only, And for pharmacies of are from that Yes. off-label. prescriptions specialty we're so the X%

Ying Huang

Thanks Great. the for color.

Alan Auerbach

Sure.

Operator

Thank you.

comes line Our Markets. from Mackay question from the of next Capital Kennen RBC

is Your live. line now

Kennen Mackay

this little if the be, factor could second year percentage sort of is Thanks continue of what quarter. patients the any obviously going compounding maybe a beyond on could to for half question, we do as XXXX. really Hi. of and a be and to to who taking patients congrats Thank of sort sense on going behind you you. to sort to expect you. the Wondering, a the the relating bit of rationale expand Thank in big

Steven Lo

a kids think breast diagnosed. Steve. Yeah. a other do everything hear small typical posing of in group yourself and here. patient the them, with reached once they've we had a who from recently were ours few few question, But patients of of the a drug a drug. again, these they cancer put I again that well. you patient now a is recently good can part to to mind really young are tolerating this are cancer This it of the and is I is back, and they think We mindset numbers were this on want they mean in that they you positive I patients focus prevent if year that coming a really patients from And who the the is,

certainly cautionary, but are those to and taking it. a have away, of better the are we this So, again, a more that I'll patients who we're as right number here, patients things small now we'll have reaching have analyzing around it's clarity certainly

Alan Auerbach

Yeah.

So, Kennen, that. can add to I if

are remember So, these early that patients. stage first all, breast cancer of

XX I somewhere if stage cancer remember breast average early correctly, old. So, patient the is years around

young. want own have up chosen who said, if as these watch women to they And are So, Steve cancer and produce and young grow babies - their babies. their that's

on with front-end said, also, do effects can So, all they NERLYNX, prevent side to And Steve tend what taking remember be they to loaded. want to everything recurrence. the

are patients these X, tolerability in one, saw is much so much, side you're not you XX, up seeing XX, time to effects month better. the the getting their month really that month So,

have Steve So, at X,XXX is can look as on graph you the slide we said, again, as of X, XXXX. July there patients

those year. The first the August, continuing be future and will beyond one who - ones be for available two for in July, would the

So, of that net-net is X% of less all than patients. our

patients, the are seeing. but metric percentage the So, encouraged with XX% XX% we of this type we don't have on are we of or

is, go So, that can percent continues go but at can it it's continues as certainly well, current can that meaningful, down and certainly be and to too. if it the percent up hold certainly

much a a for another under to I our little to we just better get wait bit just we think can how quarter and So, to have longer here then revenue belt that. our guidance want idea influence

Kennen Mackay

trying and Steve, final I'm miserably. housekeeping Alan, apologies one question calls failing you. and Got to on multi-task here And here. Thanks,

versus Just for just whether but there Thank questions. the and any to in was very QX net been you wondering taking quarter, housekeeping? the I much issue gross know inventory the influenced that that an past, hasn't

Charles Eyler

down. a experience, beginning, the in were at came running XX.X%. conservative on to to the side. with the a gross We're looking range adds Again, actually a company new in we net high XX% our little being So, no

Alan Auerbach

your Charles… on And Kennen, inventory, I question of believe

Charles Eyler

On off manufactured low. we're approval. our the inventories burning inventory inventory, was prior Again, that to stayed extremely

look at have shelves, what one the inventory we weeks is is do I which So, about sitting our three on SP metrics of supply.

Kennen Mackay

Got again. you. Thanks

Alan Auerbach

Sure.

Operator

Our Cowen. lines question the Chris Thank comes you. from Instructions] next from of [Operator Shibutani

is line live. Your now

Chris Shibutani

think were they you of be out relation enables I of kind we perhaps European particular whether when question bimodal much. seeing very of U.S. dimension kind of Are four have who a give I when the or little patients continued. believe, they more more to comment believe maybe rate. discontinuation, In number Alan, course, you the I than NERLYNX unlike you in out the an taking Herceptin, coming two patients what discontinuation there restriction the patients average a after earlier their out, if my Thank more the regulators to from that in on had the can percentage in over mix? contribution label kind year folks that FDA who regard, years as completed are you Herceptin, And in a guidelines the talking about. distribution the on what's U.S. could really that the just averaged represents second would us in stopped be, bit of without

underneath? trying that try Thanks. really to understand means number Just

Alan Auerbach

Yeah.

first So, question. your Chris, on

So, - patients as when limit specify ExteNET to although doesn't a time you're our III trial, up the to trial, that Phase Herceptin, our is which years. the two correct, remember were NERLYNX it in label U.S., for from when completed they've

like think cetera have X, to et data. would the because X, don't be I just X, out physician comfortable going don't So, we any

coming the year. seen them first year within a our of huge patients one in that majority we've large the from are to percent think think of of I kind two that I U.S. don't year period.

Europe majority the to So, to question, of we On largely to drug tolerability a the something the your see And rate we've month. majority we in the the that going now in trial of due discontinuation that's the are tend believe I that's we've think seen first with upfront, in the cover in seen treating discontinuations is And the I second that perspective month. U.S. of the time ExteNET the from trial patients discontinuation label in and what similar was diarrhea. rate first where the the highest is where similar to in kind in the CONTROL the also the highest

believe well. been I So, that's seeing have what we commercially as

Chris Shibutani

then what of of Can commitment And some the progress described us might out like infrastructure sounds Rest your has you've about Western help committed for now up in we out that own this you, outside understand partnership? of for know Western there. our to it World, that and what Europe, be at there I of for to you're cost balancing moved as stage Europe, CHMP favorably the some follow and your infrastructure implications developing your and process the potential Europe, go that primary model? could regional over to partners is out some particularly if make own I you how think announced. are you've you're building already approach you kind But direct as are able

Alan Auerbach

that forward our I from are commitment we shareholders. is would well. think could for certainly our in point, certainly but it So, that first came wait our financial And can as that. think a to be perspective building for moving implications is have the wait I think a to of build-up. the with again, of we terms infrastructure, if partnership was goal we think own and out obviously, that something at the approval. we the But at probably we And up better But evaluate of attractive, ourselves. timing And to to I the build time, idea the actual what that approval present need have I

Chris Shibutani

Thank for Great. all questions. you

Operator

would over the management today. Ladies is you. for for and to gentlemen, the I to Thank back time like we turn that our closing. have Q&A all call

Mariann Ohanesian

We appreciate your Biotechnology. Puma interest in

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

Operator

Thank for does gentlemen, and you. conclude our today. Ladies this teleconference

lines have your You a at participation. disconnect for time. And you day. may Thank this wonderful your now

Puma Biotechnology (PBYI) 9 Aug 182018 Q2 Earnings call transcript