PBYI - Earnings call 3 2023 | Puma Biotechnology, Inc.

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Operator

Good afternoon. My name is Camilla, 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. Thank you.

You may begin.

Mariann Ohanesian

Camilla. you, Thank welcome Financial and conference to call Good for to the our Results XXXX. Third discuss afternoon, Puma's Quarter of

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

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

X, quarter date but company involve non-GAAP to not no metrics events undue our as or a only our We may adjustments as conference to, we of to a forward-looking today's measures to required GAAP Please supplement circumstances investors this to You results.I for revise our Alan. refer reconciliation by financial call, except live as of refer news for this reliance update non-GAAP these certain to law.During speak the XXXX. now call call, after undertakes or statements GAAP figures. not which useful the our release are on The be cautioned non-GAAP the call, reflect to also may of will any to of measures. that turn November forward-looking obligation place XXXX date third statements, a to financial substitute believe these GAAP over to conference

Alan Auerbach

the will highlights with earnings components Jeff filed QX down second statements QX bottles.In follow a about In slides. XXXX, will will new sold mentioned add in IND quarter and to bottles of X,XXX the XXXX, or XXXX, revenue QX XXX call, in our on review the the our of provide product prescriptions, Jeff last estimate Thank by net, XX% its XX you, includes Today, NERLYNX as we inventory monotherapy the in Puma in of well as quarter cell dosed cancer, QX, joining inventory now have QX increase royalties Nougues bottles and for XXXX Mariann, sales from which the total cancer, of X platinum-based cycle. million was Maximo analysis The million. $X.X at QX then NERLYNX evaluation day as revenue enroll of for quarter II of in thank revenue $XX.X X be $XX.X of small the the $X.X known We PUMA-ALI-XXXX. reported through and with that biopsies, provide on from his to for in X% as XXXX, sub-licensees. trial NERLYNX total call reported quarter, impacted prescriptions, $XX.X Royalty of million as the XXXX, with and in of our in million to the activities. approximately of financial was the revenue approximately in XXXX. the XXXX chemotherapy be alisertib XXXX.As every plans so initial Phase in of and after our analyzed. third study tissue-based specialty pharmacies for of details of of $X.X comments Product can consists NRx, patients will clinical decrease XX all you our increased that must a net cell million third XXXX, of evaluation Puma to quarter from well to of on provide QX BID for an or today. small XX third TRx, compared were with interim Total compared million of million first-line and study immunotherapy.Patients Puma entirely third were revenue days lung Alisertib of key up bottles efficacy. million will stage Ludwig $X.X commercial unchanged $X and biomarkers XXXX, XXXX. patients I compared XXXX an XXXX.Product biomarkers will and down we of milligrams below perform FDA revenue by for QX QX a of X,XXX which quarter XX specialty of in who additional lung quarter sold reported further third color was XXXX. the QX was extensive of progressed of distributors. approximately

alisertib XXXX. was in and our safe the the PUMA-ALI-XXXX proceed. was in plus the role.The call, to efficacy the could where the approval previously announced small goal from biomarkers efficacy the with the a with paclitaxel these in biomarker study the in in comparable placebo the from II Phase potential of kinase pathway lung Journal in Thoracic to was correlate cell had X efficacy study goal trial biomarker subgroups are the believes the it August, study we aurora FDA would alisertib versus plays randomized seen that subgroups studies, of be last that a accelerated PUMA-ALI-XXXX data that in strategy.In the represent Oncology to company biomarker that of Phase discussed the published efficacy we paclitaxel patients this plus to of cancer If the As determined be monotherapy will II earnings confirm

it for the We to development includes sites multiple between hopeful to clinical of Commercial receptor enroll prior in-license now year evaluate in commercial alisertib this path over positive, investors to our alisertib and cancer commercial response are for several XXXX.As with open meeting small anticipate year, holidays.We hormone we by although during December we and in be and on there this of of a the recognize the cell patient end in the patients be This would will in HERX-negative of allow enroll several expect the conducting months. that updated diversify to leverage and in quarter. the and will patients fourth we year, Officer Phase existing lung itself enrollment keep of of during trial the performance mentioned drugs investor and the to that registration company end, XXXX, a Puma's Jeff as in able end call on coming quarter to will Puma's milestones now then initiating R&D, to continue to Chief company infrastructure. and alisertib the will Ludwig, the that a for progresses.I the before II continue continues The population alisertib for and the earnings breast November trying trial challenges turn of to review initiating Phase clinical the regulatory II potentially cancer clinical program discuss the to the FDA in have calls to Puma questions,

Jeffrey Ludwig

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

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

commercial higher start Now especially about remain indication focused be extended unmet XX% for NERLYNX, of me at our to is believe overview strategy. largely there the adjuvant of on significant let with reoccurrence. need, of business for risk We patients continues an generated.We our where

of appropriately a our on in and various the decisions We that personal and to with commercial marketing the effective frequency we to adapt on business. treatment both and more NERLYNX sensitive, and promotionally are and customers focused efficient promotion. It's increasing based organization, at teams right with time sales changes more with non-personal committed also engage are this, duration and reach given the given and believe resources our will is important becoming therapies.As

Let I'm finished, of the Once around to commercial review turn of model. I'll of some to distribution X our additional provide an me slides call overview to performance. provides transition specifics where Maximo results.Turning our over Slide I more the will detailed X. Slide financial a for

a bottles QX quarter-over-quarter the also and specialty slide. In is pharmacy which inventory of Now from $XXX,XXX XXXX, this pharmacy went at approximately some pharmacy additional slide. also by business we XXXX.Slide NERLYNX more this our XX% both distributor that X% provide to QX QX by these down QX I've X. increased identical XX% the that of XXXX. around ex-factory Inventory million, XXXX, year-over-year X XXXX, to of of is in which identical this can that in NERLYNX In we channel. insights, decline X of XX% through bottle and of We me channel estimate XXXX.Turning increased also numbers, to in QX has as inventory this on again and provide about comparison. Slide sales included so net $X.X inventory we a changes our We In the of about these was represents of bottom what quarter inventory in of model up by we remains continues QX QX what let distinct in to about ex-factory to in specialty is specialty estimate you channels of Most XX reported separated to the revenue as XXXX increased impact, channels and what approximately in specialty patients. through the million sales provides an reported me which QX that about of shows $XX.X flow the decline.Let of reported were XXXX year-over-year on bottle QX we and impact year business of refer which our NERLYNX not XXXX. from XXXX, and and X,XXX, of decreased channel. in QX we by included in give specifics a a have reported quarter-over-quarter third QX which comparator, changed $XXX,XXX, estimate $X.X channel, about about and our a million

about about bottles insights and of in about a of In year increased we estimate XX% comparison, inventory and we some As by XX me metrics patient or our NRx performance. last and declined into that year-over-year. provide third quarter-over-quarter quarter by declined QX XX% new saw QX, additional starts XX in bottles QX about XXXX.Let

total quarter-over-quarter In and prescriptions, terms XX% of year-over-year. a about decline X% we about decline saw

up pick the SD TRx or not do NRx As data we a reminder, channel. in

So quarter-over-quarter decrease stay regards about level we do patients same saw visibility have start about of for to the and SD XX% demand, X.X% year-over-year. channel.In that not the demand and in we

heavily the was weeks performance the to in across And, flow enrollments steady which customers there with not softness, we QX a a occurred positively driven decline by improvement second June, monthly Since solid month-over-month and throughout it about early our early and seen July to We country starting saw significant in have although, a consecutive in trending Now out continuing softness, July, largely quarter. in in patient the but in reported in volume. consistent several a occurred through enrollment was patient early trend. enrollments QX. decline We was enrollments inquire that increase some reached saw for week that August.

is commercial continued In in highlights line QX.Slide the in metric adoption enrollments and by October In it QX on and Grade rates. important escalation. that for of tolerability NERLYNX of a addition, escalation us daily of positive X an serves approximately are X Dose discontinuation drug dose improve XX% to as who dose. the patients and received seen QX, trend have decreasing enrollment lower diarrhea with overall NERLYNX started significantly reducing

setting highlights our the cancer. around the escalation the We to partners continue pleased committed patients in very for have its pleased I'm and making We with have are metastatic They NERLYNX several years, make seen all by efforts QX, our the available the in to a effective approval more a up battling Colombia. for more will over my Slide of and overall received X. uptake.Moving also now adoption and the strategic and setting resources, is Maximo, in also NERLYNX are launched absolutely to in Malaysia efficient by In dose globe. and financial that over collaborations we call review Slide of with long-term our more we wrap in lives and last appreciate the across The to they like colleagues the announce that of regulatory X to shareholders.I formed truly was commitment. support balancing to metastatic and fairly being the their passionate formally patients world.I'd the steady increase Maximo? team to to a turn short-term the priorities to are thanking Puma results. committed of about difference of in

Maximo F. Nougues

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

in based which quarter third to will $X.XX a the XXXX. income sales compensation we a of net million XXXX, revenue that or filed share or share, $X.XX to to quarter impact information, GAAP for On today more be our million $X.X per $X.X and third reported non-GAAP adjusted Gross share. reported you I recommend we expense, $X.XX income For per the of financial stock-based XX-Q, XXXX net NERLYNX is on QX $X.X from $XX.X this the which includes was of million net increases of $X.X by QX consolidated we $XX.X per timing quarter. of compared QX million of XXXX refer approximately $X.X revenue QX that XXXX.As or of net of remove statements.For compares versus Alan income of basis, million, partner sales it, as totaled drawdown from million in XXXX in last in to $XXX,XXX the inventory impacted million XXXX distributors approximately in million We in third reflect noted of million net $XX.X shipments inventory XXXX.Royalty revenue reported QX from XXXX. our QX $X was $XX.X the in quarter China, higher million versus product XXXX. QX our were to in from the unchanged QX royalties and believe sales QX mentioned NERLYNX The our

QX net to net QX versus XX.X% was gross QX main gross decrease prior of In XXXX XXXX. XX.X% adjustment Lower XXXX, rebates the we about Medicare period XXXX. in released in to reported QX Our the the accruals compared was Medicare of million. $XX.X driver sales our XXXX expected including that related the materialized rebates of $XX.X for not of XXXX QX related to to neratinib QX have million, license. assets date.Cost for million $X.X for was Cost sales amortization to was intangible adjustment

Going forward, licensor recognize will continue revenue of of million. product million of to that the amortization $XXX about anticipates net $XXX we milestones Puma the quarter million to per be sales.For $X.X will range cost as fiscal of year in NERLYNX to XXXX,

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

$XX net revenue range of to range million. royalties for We that will receiving in world fiscal addition, we the million expect million around the expect income for In from our anticipate be the in year partners year to the of $XX $XX XXXX, million. full XXXX.We license also $XX don't in

partners now adversely shipments, the million are any Our fourth occur are expected there end XXXX of If NERLYNX product quarter impact anticipate and to of could QX the shipments $XX that ex-U.S. range our between the it net to for are dependent that in the revenue royalties to our be $XX million. to will delays on these in revenue.We year.

to million of million further in $XX will million third the third XXXX, XXXX. of XXXX QX included the XXXX. and to for stock-based were approximately net XX.X% adjustment QX $X.X approximately that included million second SG&A the $XX.X in We compensation cash second between will anticipates the R&D for quarter $XX.X compares $X.X $XX Research the $XX.X QX of to ] unchanged of expenses gross be Puma XXXX, $XX.X expenses compared XXXX Puma compared reported compensation cash for estimate third expenses $X.X charges to quarter stock-based the net million in million were million range of burn of to million million. second of from unchanged also quarter. charges quarter approximately for the non-cash from of revenues $XX development QX the XX.X%. million.SG&A a quarter.In quarter expect burn of royalty million, be [ the non-cash in and QX for million We XXXX this third XXXX, in quarter. in to income QX $XX expenses $XX.X

approximately expenses $XX and approximately X% On the XXXX. Puma in securities. by side, cash, to or in September XXXX increase a expenses X%, X% expense continues to total cash reduction XX, to increase we X% anticipate to equivalents flat to anticipate XXXX, SG&A in we and to operating had million marketable R&D year-over-year.At expenses specifically, More compared be

balance million. receivables $XX accounts was Our

receivable distribution outstanding September XX focus are deploy terms we on range accounts our our our and and We about expenses. days, days. approximately of estimate between XX of our while XXXX, of X Overall, commercialization of Our maintained NERLYNX, XX network weeks to days the development the controlling resources XX, financial alisertib as that sales inventory. to continue

Alan Auerbach

Thanks, Maximo.

are believe also we reflect the income, There for income battling well that of Puma XXXX company need operational during reducing as to in strive achieve cancer cash goal.This breast significant and NERLYNX have to if the in expenses that the committed We cancer, the needed, lung to flows their expenses contributor a income report income positive positive net in presentation. and investors to cooperation expense remains perform at achieve flow and are during passionate tumors. the we cash to the about third maximize and concludes continues net to quarter these on We We reduce look with beyond.In year continuing continue third improving order helping in a for The to future. patients performed finding we'll XXXX. solid to pleased Directors continue continue operational achieve flow ways flows. that this. implemented reduction remain previously to fourth to other journey reductions. expense expenses goal with in order is positive unmet patients in cash these quarter these more We to XXXX.The reported flow at major the and effective cash net reductions we management of on focused XXXX, of and continues company senior quarter remain positive will Puma as net to are in to Board positive sales the cash positive this updating today's a forward and and committed that anticipating full and of the

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

Operator

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

Edward White

is a free and you it. quarter? drug the this sort question housekeeping experienced of percent was First I thing, what past missed just of maybe But that

Jeffrey Ludwig

And any And if that you. percentage. give me I'll decreases just drug looking moment, seen find significant we've over last the in to for I'm you But exact change not quarters. several or increases free that a

ask So give me X there. I'll percent up give a second as second your question, you you

Edward White

was prescription wanted new fourth confidence you'll color Okay. other too, weakness in see that bit recovery about get you, the the question for into more just little Jeff, in to the what August quarter? and a you and July gives a and

Jeffrey Ludwig

of said -- what I upfront about early. consistent been little question saw free color. And free Thanks the of more for give the remind and drug, bottles. total And on me and softness quarters Great question. just over we terms last you in XX% drug, bit you several that's let in fairly the a for us we we're

in my those week we July we in changes, starting the about the any impact June I country out anything check across as weeks. we solid have drop second we And X I the and on but or consistent. there. did look As remarks, see flow a enrollments see didn't to patient reached first mentioned, Obviously, opening patient kind at in for of July, just trend mentioned to in and week customers did we

And either at pathways, can from do from impacting any mentioned just sales and that I'll do promotionally factors out.We to other we point look internally. many to competitive guess, I significant times, also there look tell is you, nothing standpoint believe activities, make we is you sure as formularies, NERLYNX sensitive. nothing As is

with And so, vacations, as see we QX. saw do to and tend call not improve. we for We slight that in early, uncommon tends expect as QX, I that, a in that QX and to look drop activity holidays at occur to

our make close to to et wide efforts July, pay promotion, moving improvements saw and sure We good see very well, days that broader September. in I softness reminder, in did also as attention and adjustments in we looked We broad mentioned, cetera. but at saw promotional frequency We've we as that QX. have that non-personal forward.As And throughout some to we we made early reach insurance a August. improvements

seen continued have also We October. that trend in

seeing. final me, asked gives we're part helps. that and me is It the of that you your that as the seeing changes. question trends what confidence Hopefully, the So was, we're numbers

Alan Auerbach

Yes.

Ed, So if I can in here. jump

you want this the holidays. December kind looked in go who We get because always you for think due didn't it about spike effect in on far didn't side patients want which first is If enrollments how go that profile, so the January to a have the to to year. want on the to usually month. drug in see the of up We

spike. in was big in of June, March, jumped higher August line May kind May, April, and time was then that So set that February, It's August, with September period. higher in October July.And been down kind in than February good then and that and -- very then July, was was had higher relatively than September, similar of jumped more it basically was up it October baseline January, than in it through

adjuvant out July from taking or Remember wanted gone complete have speculate, they So people through the years would NERLYNX. patients X side whatever vacations that look, that to in be. to be were effects, and you June could the can up who to spike, when have is therapy okay, take

seen start was metastatic back X be disease.So holidays Again, vacations in the have concerned flexibility of don't of or think really to the about. they we think launch. to year more have I disease said, away Jeff them It's not where gives our it's when right Tumor -- it we're like we're in little a recollection, on whatever. a people this it's because So before. then, what drop they July And you not have previously. were taking the come really it's -- something to like assumption numbers We or back anything it's start.

Edward White

also is raised excited on seems sales revenue outside your And somewhat guidance, to the impact you by like U.S. the Okay. on thoughts particularly the want overlooked get this ex-U.S. potential Obviously, your it potential. royalty investors. for on And in sales, I just China. thoughts

Jeffrey Ludwig

Yes. Ed. Thanks,

you launch the China at in the do job out, in QX. So numbers, rolling the a our wonderful there. to if done coming is of a bolus has big the We royalties still tend see, and partner look

expecting of is execution.I we're probably say probably think with nice second very patients. area year. The that's So we're the our It's rollout pleased for to it growth. like coming. last us I very, where looks they've And year, been did just royalties market in largest that going, royalties, number seeing this it's the We've highest would and that just is from. China due a job we our of still like done a terms with

would show numbers And the got in it's that. think I some to the I continuing go that to momentum still there. see forward obviously So, future. to look And

Operator

Cowen. Our line next Divya from with question Rao comes the of

Divya Rao

get FDA. there in I having small yet metastatic explore could a follow-up alisertib a to you've other to -- you anticipate just how see cancer. of a trial guys to wanted the Phase developed Or then an have this that is or guess, you to And similar being better therapy you trial? do agents success potential this that Phase But I that with know ideal you given also in are the idea do breast combination here? define design space, Marc. in in what to for would cell Divya speak trial a III II? a the like career, you I is that, with of the This

Alan Auerbach

question, Thanks for Divya. the

indicative a with So are populations activated. we focused biomarker kinase there's on of the aurora alisertib, very that's biomarker being pathway the where

example, And as RBX yet c-Myc been with lung cancer and so, that the and in well. trial, there's a few cell haven't others the with for small the published you saw that mutations,

setting. to your paclitaxel previous correct. getting of using trial The cell after of also that would after endocrine be that cancer, the use terms earlier been plus they you're CDKX/X, kind the it to has perhaps drug. in therapy, the they've the done was that agent been looked it TBCRC has plus be of we've patient had it KOLs a against the with placebo. from endocrine kind would would the pre-chemo of of position they've would they of small was more another alisertib paclitaxel had similar kind XX, that's The setting.So in to of pre-chemotherapy kind involving an therapy, in where question, In then and lung the where position would to it alisertib be where like done, feedback kind study was specifically, like kind the And it,

positioning would where that it. we'd So be be

question You well? had follow-up a as

Divya Rao

to this wanted do agent just areas I other how do given are in helpful. developed, being -- you trial that a the know, this trial like single define you how like setting? is KOLs, the just if That's success and it in

Alan Auerbach

Yes.

endocrine, alisertib don't endocrine plus easier placebo So plus be would the if against be or alisertib plus to do obviously alisertib know trial like trial endocrine. alone that will an I

it's trial. a well-designed, So well-controlled

here cancer in being PIKXCA a like. in which success precedent especially, is me, the the is good of which There other what is drug. but of is look tends lot post-chemo pre-chemo be to setting.In lot in good for ADCs, that setting, a of the developed HERX-negative agent the a chemo mutation of would agents, a -- there a There's correct. and pre-chemo excuse terms setting, more of You're not PIQRAY, targeted kind breast ER-positive this

type And kind pre-chemo be think would you developed alone, for. plus population, a be of type we'd was do, against will, we'd what and of -- design that it so, that that what PIQRAY be of outcome was to looking endocrine I which looking in if playbook, would be endocrine

Operator

the question line Barclays. next Wang from of Our with Gena comes

Harshita Polishetty

Harshita for for cancer, perhaps the couple ones, is This FDA breast A of on for meeting did XQ for Gena. Alan. already quick request Alan, the meeting? you

Alan Auerbach

next is month I Meeting remember and one. has scheduled. either been Yes. which this can't requested or month. It's

Harshita Polishetty

the XXXX. then starting -- probably you provide right question guidance. in understand we provide lung with have as and would you've potentially expenses the for any very trial second, see -- the that color in come how to XXXX, to start helpful. cell you then the you're now provided cancer I able Perfect. can to detailed R&D? But small I be color Any full and alisertib, provide Are And and changing like on on a should you will guidance cancer regards quarters trial breast on

Alan Auerbach

Yes.

from study, some R&D the Europe, to -- of done was a then in perspective, a commitment forecast, the control have we're we study, have sites, still neratinib in European population. R&D previous similar a of on lot -- the And is it in basically the which remember closing we So come an neratinib so being study had out. using there post-approval which was but still that down is items a those -- to

as diarrhea. so that an That extended neratinib as different will and coming be will expenses out all concluding looking ways the the well. be reducing from of at adjuvant shortly, So study the

-- it had we of correct in, gotten and think very us a at I We into cell on be had coming lot income coming a as items small to what well breast. positive HR-positive company. that. we have going the one lung net and budget be we a continue the do we we the listen, said earlier, important that R&D expenses to alisertib of And So conferences got question would is was, out.You're one

So not if of we development completely drug that's recognize responsibility. to our to the have fiscal to in order developing that, we're the to do. drugs, what but We just stagger responsibility new our in going cetera, also et do then shareholders,

something important be company. is And so, is we think able net to that positive a very income being

our commitment is that's maintain to to what going have expense, we stagger income to trials in if the positivity. do So the to we're But stagger order net do. that,

Harshita Polishetty

many you have That's I lung anticipate opening cell question. mean, helpful. -- how cell the trial? sites cancer to yes, quick disclose And small I one able cell for on trial, Are small you small last just

Alan Auerbach

number is memory to me. have That somewhere ballpark like if maybe I XX, a is XX front I that I in general question. of XX remember, My don't XX, good XX. that apologize in to range,

Operator

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

Mariann Ohanesian

joining us for you Thank today.

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

Operator

in This participating conclude program. call. for and a gentlemen, thank Ladies day. does you, and our today's conference have Thank great you

may now disconnect. You

Puma Biotechnology (PBYI) 2 Nov 232023 Q3 Earnings call transcript