Earnings call transcript Q4 2022

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Operator

Good afternoon. My name is Diego, 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 IR for Puma Biotechnology.

You may begin your conference.

Mariann Ohanesian

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

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

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

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

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

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

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

turn call to over I will Alan. the now

Alan Auerbach

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

sub-licensees. NERLYNX fourth the fees $XX.X quarter includes as net, for Total revenue in revenue in of revenue revenue total million reported reported QX as product our $XX.X XXXX, and of million. of million of $XX.X from license of XXXX Puma XXXX. Product reported Today, sales, XXXX was royalties fourth QX the well in entirely $XX.X consists and which compared quarter net to million

XXXX and revenue quarter $X.X Product specialty revenue pharmacies for increase million and XXXX. in our $XX $X.X quarter from of in an XXXX, Royalty no million was the fourth in an revenue fourth inventory XXXX. increase approximately reported of in build from million included in $X.X of QX XXXX distributors. of the of QX license million specialty We

XXX comments bottles approximately in QX to compared reported QX in and his fourth to flat NERLYNX compared QX of to quarter QX. inventory QX details Jeff bottles. down bottles further prescriptions XX% provide XXXX, new that build total to We In will the sold prescriptions were amounted X,XXX XXXX. and in slides. X,XXX sold were estimate XXXX We approximately of of compared

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

XX hormone neratinib has mutation. of neratinib in cancer HERX As as trial in Puma receptor an patients basket testing exon And had investors breast an non-small are lung mutation. ongoing cancer SUMMIT with that that which positive patients aware, metastatic trial was the with referred has HERX-negative cell to metastatic

us and on drugs populations instead the that investors SUMMIT in would head that to As we in neratinib the require the indications neratinib to with that unlikely other these care was a or treatment past, in not we accelerated of it two, approval standard for study mentioned in changing to head FDA do rapidly grant landscape. patients data one, either overlap trial against believe do would based

interactions with the these the of suggested approval be precedence which will indications indications. recent further on the that company Based in FDA development would and not neratinib a require pursuing regulatory in randomized trial, these

Due mutations, would to randomized able being be the the clear based shareholders that a reduction results in trial not the market accomplished and would it trial trial be these result versus on is time XXXX. in Puma The XXXX in potential this timeframe to cost enrollment rarity cost a and of from and therefore that for return discontinued, SUMMIT opportunity. of positive studies would is this challenging be in a versus the which

neck agent drug September, was we has triple other that with clinical Takeda. single in head cancer. combination of the in alisertib treatment In including and and cancer, shown breast drugs negative In to breast activity to cancer alisertib pleased cancers hormone and Puma various anticancer cancer announce in-licensed trials lung small receptor activity from cell date, positive the cancer,

in also over a previous T-cell lymphoma characterized across treated XX were Takeda's clinical trials was who trials. previous of X,XXX The well development to due patients large database in lymphoma. there peripheral activity this, non-Hodgkin's drug safety is shown clinical And clinical company alisertib has program sponsored and extensive. with

alisertib by the earnings As Puma. held This currently successfully mentioned been IND now in in Puma. and the is program being completed Puma process from our Takeda last of was has the call, transitioning to

of for are second with of will small cell and currently alisertib we FDA cancer discuss in in subsequently would path XXXX. be small anticipate registration first lung to trials meeting lung XXXX the in the alisertib clinical anticipating of cell that in the the initiating half half We cancer

with meeting half in second alisertib cancer of clinical of alisertib positive in receptor We and subsequently initiating to receptor for hormone the cancer HERX-negative FDA trials hormone pathway 'XX positive registration HERX-negative XXXX. first further discuss of the breast half in breast in the anticipate the

trial randomized positive versus in studies of receptor will We continue in Biomarker clinical in the is 'XX. of alone pembro the and anticipate be cell alisertib treatment with FDA versus the trial with Phase for the positive alisertib includes we which of the there plus the of half is of for second the 'XX. discuss for program of cancer, neck anticipated HERX-negative and X/X anticipated which half 'XX, receptor receptor from hormone in lung alone HERX-negative of which paclitaxel This breast the fulvestrant expected conducting path the the plus to cancer, to hormone the and anticipated coming of XXXX. FDA cancer, alisertib cancer, the of half from small registration in milestones HERX-negative first breast path several in XXXX. hormone investigator-sponsored which the publication in for patients alisertib first first the anticipate meeting that from meeting alisertib cell ongoing registration alisertib discuss months. squamous sometime the biomarker cancer, alisertib randomized data And head Rb-deficient in the trial data breast half paclitaxel the to the with plus positive is Conducting

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

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

Jeff Ludwig

everyone Appreciate Alan. fourth I for earnings appreciate And joining our it. Thanks quarter call.

The helping and just making forward-looking support review, into reminder Before breast battling team I cancer. will more about that passionate commercial be a I statements. focused move commercial remains on patients to the

become primary patients see metastatic. helping breast their more on of HERX-positive stage never to risk Our in love emphasis patients cancer. is would reduce early recurrence We

two, three around focused through the finally risk remains increasing HCPs. around our Number communicating and evolving areas. of for the strategy force Our data positive patients NERLYNX. three, the impact Number benefit of share reoccurrence, risk well in of engaging educating clinical non-personal NERLYNX execution promotion. profile as and voice field to one, And as

our Specifically year-over-year we regarding regards of QX calls metrics, looking an starts enrollments, pleased QX increase as voice, patient also In I'm new at QX comparing on XXXX. and year-over-year that total well versus saw of demand. share including saw key as to QX, in QX very we growth

our of an versus were calls which reported the is total XXXX. live from XX% In about of virtual, QX we in QX XX% increase

increased very but made, know goal we being our teams remain more and the field of effective. their with opportunities being engagement organizations and remained with advocacy our I and that expenses and overall efficient about regional still progress addition, more diligent have us. thoughtful the In of am significant local front with pleased in

update, the call results. level let I slides. Maximo, transition high for to that of detailed U.S. a over With financial review Once turn the more some have of I commercial our will me finished, to

model changed. distribution Our not has

to continues channel specialty channel, our channel. these or We refer see approximately business the no provide as channel. to of channel. business with remaining through of Most In have throughout NERLYNX channels this two QX, XX% flows specialty of pharmacy and our through the We our patients. dispensing fluctuations in-office the distributor occurred our to We of the the significant some specialty specialty business year. distributor but pharmacy quarterly this mix, channel that XX% changes do through went flowing

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

over million XXXX. increase Alan This quarter $XXX,XXX As a of of net a XXXX fourth $X.X decrease is noted, our XXXX. over million QX $XX.X product were in sales of the and QX

Now inventory an numbers. on these have impact changes obviously

quarter of we the inventory estimate that fourth by $X.X increased In approximately QX, million in XXXX.

by approximately $X estimated in As of that a we increased million comparison, XXXX. inventory QX

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

XXXX. that provide around fourth more the bottles about Let by inventory a in me inventory We quarter increased of estimate again little changes. XXX insights

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

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

and year-over-year performance not these we quarter-over-quarter growth patient however previously across growth for our including see saw We our key metrics. did As metrics new same enrollments, mentioned, QX starts demand.

As potential typically of new order after choose we starts month their the a softened holidays therapy the occur to patient their in reminder, which fourth physicians first and the and/or NERLYNX, seen initiate or patients so. avoid enrollments have historically effects side in to the quarter as in

pattern that QX followed decline. quarter-over-quarter of XXXX of traditional

in QX, saw comparing enrollments provide X% The but of me performance. some additional this are that specifics we quarter-over-quarter patterns. growth quoting QX of Let QX year-over-year, rates declined XXXX to around In I'm XXXX. previous XX% line with grow year-over-year

the patient new patient Commercial saw quarter-over-quarter. an refills declined for new which on starts patient leading XX% grow X% starts quarters. NRx. turning us subsequent starts Moving patient to indicator We influenced commercial or as year-over-year new are starts but new important

Total quarter-over-quarter. more prescriptions In trend positive similar than remained total we being year-over-year somewhat RX quarter-over-quarter. QX, year-over-year growth followed X% with flat a saw and

to and the we first these For grow XXXX, enrollments trends. time patient positive new XXXX have the commercial starts This saw approximately we comparing yearly is X% grow full launch X%. seen since year

X. Slide to Turning

continued education slight to a focus escalation. lower reported of we of QX, commercial on patients NERLYNX In approximately in QX. have is the a who the started We daily on XX% approximately adoption decrease and from drug XX% dose received This dose.

of discontinuation of a Dose the escalation truly the the adoption role amount benefit median dose the plays believe X profile days overall and reshaping We patients reducing very X in by clearly diarrhea risk-benefit Grade important diarrhea, of significantly escalation can of the NERLYNX. Grade rate.

previously for reported, both as of to late the as was NERLYNX June As the well adjuvant in XXXX the indication. indication extended escalation label dose metastatic added

pleased recently escalation NCCN say early-stage practice dose updated include NCCN breast to escalation to cancer. their cancer XXXX updated and addition, option am breast I in as included metastatic in well. setting their dose as metastatic an XXXX that the In clinical guidelines guidelines

across collaborations strategic formed the globe. the highlights X Slide Now have we

launched of South with are In partners Also approval both to the We QX and the are Mexico extended being our in Morocco regulatory the NERLYNX made. QX announce we XXXX, that adjuvant setting. in officially global Africa. adjuvant was extended in progress and in XXXX, NERLYNX happy received in of pleased setting

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

future that as organization. Puma journey. NERLYNX I passionate of commercial and support opportunities along thank want The In hard and cross-functional in for a do XXXX, I foundation that change work their my pleased and to to for build colleagues to we committed entire finding about is team more historical growth. cancer the and the solid team progress trends some the made with summary, XXXX am year worked was was an important the the patients to

I will now Maximo of turn results. our the call for a review to over financial

Maximo Nougues

Jeff. Thanks,

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

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

fourth per net or quarter of a $X.X share. QX This a share. we loss on of $X.XX per GAAP to or $X.XX $X.X million loss the In XXXX based reported million net XXXX, of compares

Our fourth quarter settlement in increase XXXX include of our to due lawsuit accrual $XX.X an results million. legal a

year, net $X,XXX. full reported of For income we the

net per basis, non-GAAP the remove a share reported which is compensation million the quarter we to of or impact for fourth On stock-based expense, XXXX. $X.XX a included of loss $X

income non-GAAP million. For the was XXXX, $XX.X full our year of

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

net from believe approximately was in quarter of build NERLYNX mentioned, sales of $X.X third the million million $XX.X revenue included QX reported net our As 'XX. We distributors. $XX.X Alan million inventory to the product sales compared that from

revenue quarter of in $X.X at compared Royalty the million XXXX. fourth $XX to XXXX QX totaled in million the

QX reported in adjustment gross-to-net the XXXX QX XXXX. XX.X% to net gross compared in about to Our adjustment was XX.X%

drivers Medicaid million, QX $X for for for of government to $XX.X and Higher was the Cost of license. sales higher XXXX XXXX chargebacks amortization rebates, our related $XX.X Cost XXXX. million. increase sales QX QX including were of versus co-pay of assets intangible was neratinib the the million

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

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

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

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

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

prior to bottles to lowest product sales over to that build quarter due in of of year, which Historically, represents including net fourth the the first the the quarter of in inventory the number channel a factors, gross has as expenses QX and the year occur a the negative the coverage in higher co-pay higher as first on in typically GAAP well effect sold a net due quarter. quarter

delaying bottle. fourth million. of The impacted reduced sales Jeff XXX patients This quarter during anticipate XXXX, that of NERLYNX will NERLYNX first are to We assumes be XXXX, negatively $XX the for is $XX sales QX the net by quarter by in range that also inventory which starting guidance described. million

further We Puma be between gross million to will China. to net This expect QX approximately We from million, QX QX net $X adjustment in Siemens that will estimate be to royalty QX. the million our in XX% range a a decline XXXX revenues in $X decrease XX.X%. anticipates the of million. loss $X timing of and to reflects partner $X the

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

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

to quarter $XX.X XXXX, QX lawsuit of due settlement. cash million to our impacted earned Our net cash earned compared Puma approximately an $X.X to accrual of approximately level in fourth XXXX. was by loss increase The for $XX.X reported million of the the of quarter million

payment QX made to XXXX flow in that cash Our included million $X a was Takeda October.

have flow the full we XXXX, of cash that million. burn reported year, flows of positive $XX onetime impacted we exclude cash events cash would For million. we $XX.X If seen

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

and At December we in approximately securities. $XX equivalents million marketable had XXXX, XX, cash, cash

balance $XX.X receivables accounts Our was million.

receivable of XX days while outstanding about range days, XX of that accounts and distribution our year-end inventory. sales XXXX, Our maintains terms as network days. estimate XX are between We our weeks four approximately

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

Alan Auerbach

Thanks, Maximo.

our access last we saw during results believe call, we increased commercial in we XXXX, interactions HCP contributed with better on experienced As which that and noted to HCPs increased overall, earnings XXXX. the face-to-face

that this hopeful are to We positively. trend continue will

in remain expenses maximize implemented XXXX NERLYNX sales with the Board a management focused to with XXXX, in of the operating reduction in of we beyond. in on flows. and goal In to senior cooperation quarter continues of Puma expenses Directors, reducing fourth order cash improving

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

tumors. this significant battling unmet on future. in investors and need in continues to cancer remain updating lung cancer, solid to patients forward for look breast We the That a other

achieve effective we and to during to ways proven and helping and continue have their finding more strive are these We patients will passionate goal. committed that about journey,

This today's presentation. concludes

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

Operator

Cowen your and with comes Company. first question. Our from Instructions] Rao Please Divya [Operator question state

Divya Rao

before on label alisertib in there and any data think specific expand breast Thanks with was regulators Divya both question. you're to for generate is I taking cancer. Mark. guess I prior is our for cancer, cell hoping that guess, like breast to This meeting for HX the small guidance Hi. I

that's -- into or QX So guess moved HX. I

I So data was you additional was any just generate. if wondering were hoping there you

Alan Auerbach

Yes. the Thank for question. you

the yet oral that those on and where a is to like there's A the the you of trial, we be My number with alisertib So alisertib plus accepted alisertib. my deficiencies we on against data. express publication, that not is against biomarker has biomarker got tumors journal lot And waiting understand gotten that, plus the plus is target been alisertib, inhibitor. call, a as recently alone. paclitaxel and believe c-Myc for which things RBX alisertib of fulvestrant pathways, that just data, back for study kinase going from know, to previously data the our fulvestrant. belief just like the the and loan, alisertib The the to are publish We've an we of paclitaxel data which best that. highlighted we're that That

again, And So we are hoping that. I trials. are investigator-sponsored think these for

So groups. they were done actual

think to I meet the in out got hoping FDA for it. move second we half. order had with because were that have to were just We to -- the we

Divya Rao

you. Thank helpful. That's

Operator

you. Thank

Your from Geoff Please question. America. with proceed of Bank with next question your comes Meacham

Unidentified Analyst

This is calling in [Hao] for And you the afternoon. Good for Meacham. thank Geoff question.

$XX color the quarter And more do revenue for can to then that from my the also what a to that sort head if start reduced wanted than for physicians studied we really hear may one to other improve Thank about the number the you. bit main seen? what of patients higher just million, can dose. And hurdles drives year. prior a So What at the reduced sort of that you dose. is the provide be prior percentage of a royalty and about regarding I that have first one we patients

Alan Auerbach

Okay.

reduced the Jeff, one, that? dose, to take first want the do you On

Jeff Ludwig

Thanks we has escalation and very important to. dose Yes, question. the neratinib well escalation adoption profile. of Appreciate the for it. received. risk-benefit the think really to is Obviously, happy Dose been

early to we support and see Our to breast our KOLs. dose guidelines teams been our metastatic. And discussions stage very from and around good talk leading about added actually added for it It's consistently. been NCCN insert. both escalation It's package

say, And do physicians adopt. certainly you is adopt at, some want get group you're a So let and why full that who on me start the in that to the that of They initiation. give setting immediately those largely about think adoption as There full metastatic physicians with dose we graph believe upon should around is, a hey, dose. just more we're showing. you aren't that XXX% treatment don't we question asking color

a subset will to not there's that So dose. with a reduced start likely going

the Number of with way two, dealing long have community we that their with dealt not they've challenges neratinib diarrhea, for do in have managing got it. have time a and own do physicians some that

reduce. they dose with a have And start full dose if so they and they challenge,

methodology dose the the channel, have consistent, the pull from numbers visibility it's surrogate. adoption escalation. The is SP I third you, although as is before, We that our SD I'm that so is undercalls it which, into channel. situation about showing our believe we very business, mentioned good do XX% that of data really of We not complete very a

the And one for SD portion SD their of it's in subsequent move uncommon the to them and the for for in business, a fill the to channel then and fields. SP patient if example, second time starts over not channel so

when and they likely start, they'll over as starts started In the full dose, that it's low SP, full on dose. escalation at the though example, in a if to we'll SD come dose a in even that up they patient come the dose pick

believe, the numbers, conservative. quite these trend. very happy are So overall And with very we honestly, I'm

that might full I'm max XX%, adoption. see, we'd be ever almost I would the that that XX%, guess be would estimating

So more hopefully, color. little that helps and add a

Alan Auerbach

as And know, portion policy. had COVID is Zero the largely China, question your you our can they a of second then to in with things royalty, such the And regard based royalty China. fluctuate large on on shipments those to the

of for waiting a to the -- just so us open times, lot be to for window to it was of And were ship. we kind able

that causes kind of bumpiness that So in fluctuation that occur. to

higher the QX. than expected why that's you So saw in largely

Maximo Nougues

become as So that won't Sorry available deliver ship Also, -- we we well. right? to batches, when manufacturing that. budget large add

So.

Unidentified Analyst

helpful. Thank you. Very Okay.

Operator

Thank you.

from Wang Gena Please Your with comes Barclays. state question. your next question

Unidentified Analyst

for A from Thank on afternoon. This [Harshita] one Good is Hi. taking you for our quick us. Gena. questions.

been to to you since on update So you need virtual this year of Thank accounts back how additional you are current was I a give out? working doing XX% wondering, through add an clinical think well specialists? been over with right, given interaction. Do specialists has it's sales can XX% Or reduced are us you force? you. you your fuel the

Jeff Ludwig

Yes. many appreciate know, Harshita, thanks It's is, though things. A other positive as become the -- lot seeing even couple that areas. is of I it's a you than since question. tell I for more up. COVID, the it. therapeutic opening back even trends area One oncology you specialty. will more of offices some restricted some we're the a very restrictive restricted obviously at COVID

said good the we So They're we're calls, where can monitor I've able this if virtual. closely, we are our in open to size tell more I we and very opportunity not physicians. right sales feel cover and have We on about correctly, very will get of previous you either staffed accounts that front now, that live of an force. accessible, or where

will on Alan efficiently. we're have necessary. and of as and a or right and very quick the conversation virtually, effectively amount now, accessible fairly physicians like managing and we But either live I will that, feel we accounts adjust

increased actually calls looking -- the seen about we've As fourth I year-over-year XX%, at mentioned, XX% about and quarter. overall calls quarter-over-quarter

So with progress. we're happy current the

restrictive. is again, oncology specialty And

nonpersonal access. engagement we try generate our clinicians promotion with increasing also cannot those to that to we're So

bit. that So little a helps hopefully,

Unidentified Analyst

much. you so helpful. Very Thank

Jeff Ludwig

it. Appreciate

Operator

you. Thank

state comes next Sahil Kazmi B. Securities. from question question. with your Please Riley Your

Sahil Kazmi

for Hi Alan, our here. thanks taking questions

couple from a Just us.

you're well of to cancer. color First small you cancer talk you're cell the with in can have squamous in all, about half year? there lung planning first the thinking as can Any the about discussions head provide how you and FDA as opportunity of neck the the

Alan Auerbach

combination a question. head alisertib patients done using of so Thanks with purchased to -- and Takeda Yes, in at ongoing RB investigator-sponsored neck an the from the pembrolizumab deficient this being in was that for this is absolutely. neck as study that's cancer, we time drug the with In cancer. head study,

really I smaller think before opportunity. comment to the a It's see going data we're the can to type. have we tumor obviously on

of think just on is kind trial I getting enrollment. going

would frame. start -- expect just this a find to time present of I So conference expect see QX-ish in probably is to it, some probably to I ballpark probably the we'll to when we'll QX, data we year have it data, hopefully QX if

think once we'll opportunity. get we to more data be on happy I comment the that, on So the

small alone. cancer, In remember Aurora study Journal versus is paclitaxel Thoracic Oncology lung is kinase cell paclitaxel terms that of inhibitor. you'll in there alisertib a of an of Alisertib published the plus

of are c-Myc good a cell and that. and lot in of things present these pathways, includes which in the cancer like pretty RBX So a things small deficiencies percentage the mutations, lung like which patients, elevations RBX

seen PFS was efficacy OS best that both trial. the where includes and That's a benefit an and that benefit in

kind benefit, opportunity the cancer. something of to lung that but also small is just the that's is maximum best we'd our show biomarker-directed discussion drugs the from on in with the drug cell the benefit, of feeling showing that going be best to with our the like really approach possibility FDA what the to I risk think alisertib most have So because differentiates other

cancer, way APP like cancer last lung cell have cell lung that. have tumor And cancer drugs. the other ones that cell Certainly, of the mutation, you cancer. Small than been you largely has lung in has a various cell the a just in lung haven't and things cytotoxic mutations, IO in EGFR consisted you non-small biomarker-directed small really non-small approach drug, the the seen

cell of approach the approach and seen biomarker-directed the that's really small cancer same haven't we're in really You type take. lung looking to

on. going with that's to the focus FDA So is the where discussion

Sahil Kazmi

XXXX. helpful. on the very story the following That's forward in progress to Congrats all Excellent. looking and

Operator

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

Mariann Ohanesian

joining for today. us you Thank

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

Operator

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

now may You disconnect.

Puma Biotechnology (PBYI) 2 Mar 232022 Q4 Earnings call transcript