Earnings call transcript Q3 2022

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Operator

Good afternoon. My name is Paul 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 over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology.

You may begin your conference.

Mariann Ohanesian

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

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

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

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

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

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

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

now turn call to the Alan. over will I

Alan Auerbach

Today, our reported net product you in Thank XXXX which in reported second fees consists of revenue the represents total you, thank was revenue of well includes Mariann as license for sub-licensees. revenue and and million of net sales, today. from third third revenue in $XX.X quarter Product of Total XXXX. quarter million royalties all increase in joining the the NERLYNX $XX.X $XX.X QX $XX.X product XXXX an revenue revenue as product XXXX, million. net, in which and our Puma million from the of entirely reported call for quarter

to of equal XXXX was Product and comments We In QX Jeff and revenue in compared recorded will revenue in approximately compared $X.X XXXX. $X.X bottles. about distributors. prescriptions, bottles in X,XXX were and our sold QX amounted the of for second the XXXX, We third details the in QX Royalty $X.X quarter of the of total bottles in to and his new that in up QX inventory NERLYNX were to approximately up build the to quarter QX We prescriptions, XX% provide reported X,XXX TRx, X%. slides. estimate sold further XX XXXX, NRx, pharmacies at in inventory license of of revenue quarter. a third QX million from XXXX. decrease quarter million no specialty XXXX million million included $X.X specialty latest approximately build the recorded

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

NCCN metastasized run brain. brain. the metastatic prior Cancer that patients the being neratinib the tested by TBCRC TBCRC, to has metastasized brain in results plus aware, in cancer the neratinib neratinib HERX-positive is to that patients that the the Translational is of that trial, cohort investors neratinib an Breast for there XXX from metastasis, in clinical listed testing which has known ongoing resulted with of in of As is with guidelines Consortium, the are capecitabine Research being treatment trial The breast breast as cancer

The current trial two results trial, cohort plus neratinib the testing the with been patients the treated combination which treated tested of presented the Breast Kadcyla the of Symposium Cancer of will to that not previously brain. HERX-positive has be have who have patients this in patients with in at San The Kadcyla with breast cancer December. is from been combination in Antonio metastasized who and Kadcyla, in cohorts previously

in also meet basket trial. to with this of an are Puma HERX the half with cancers investors first As HERX ongoing of for as arms trial. has regulatory the to in Puma discuss FDA neratinib path potential plans neratinib aware, mutated SUMMIT trial for the of XXXX two the

triple cell EGFR, Puma receptor or factor have Patients of lung inhibitor. In with alisertib, has hormone cancers, cell to with mutations, an including lung and to pleased with kinase non-small with cancer, many who a receptor growth head was positive date, HERX different alisertib cancer exon treated and Takeda. patients that epidermal HERX-negative metastatic positive have drug, the mutation combination cancer September, neck previously in clinical breast In shown in-licensed cancer small in who other been announce cancer and activity in tyrosine with breast negative breast drugs trials the cancer. EGFR hormone types XX we anticancer single-agent cancer, from activity treatment of

due was is a shown will Puma end with were the with in company-sponsored also peripheral T-cell alisertib extensive. We clinical clinical development over has who of across drug from in this to completed And The lymphoma trials Takeda’s process well-characterized safety patients lymphoma. of database majority that there year. large in previous this, non-Hodgkin’s be transitioning by is Puma. program the the treated currently X,XXX and the trials. of XX program the Takeda anticipate clinical to activity alisertib previous

is for publication which of from trial of paclitaxel is be from the positive includes breast treatment XXXX. head paclitaxel studies receptor first HERX-negative alone in cancer, months. to biomarker alisertib anticipated alisertib QX HERX-negative data plus expected randomized the in that cell Rb-deficient the the XXXX. neck data randomized of in from alisertib trial alone of plus is trial there receptor in which the squamous the continue positive versus versus which and the ongoing XXXX with milestones Phase half alisertib anticipated of hormone in cancer, coming and anticipate program the pembrolizumab We Biomarker cancer, hormone breast for This several X/X fulvestrant plus of in clinical will also patients the alisertib investigator-sponsored

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

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

Jeff Ludwig

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

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

and appropriate Our goal increase the growth. consistent is adoption ultimately of NERLYNX generate to

to communicating and well finally, as and not has reoccurrence voice impact of execution. remains and areas. patients engaging the the risk-benefit increasing NERLYNX; and HCPs; educating around share NERLYNX field focused Our the profile number data one, for as three, changed evolving Number two, three risk positive force our clinical of strategy around of through

QX was on well. has say call progress I stated all I progress that that am as earnings I to X in continued QX the felt made fronts. on pleased

continued and to tools to teams Additional support resources story. rolled further and per increase, our field organizations. clinical were local engaged regional our with calls out day and further HCP advocacy

approximately HCP in were versus calls saw In More growth of virtual. we virtual continued interactions. XX% live addition, versus in live specifically, QX,

financial added our moving call we over Maximo Lastly, will NERLYNX to let community I we I oncology results. turn in With practice U.S. of the am to update, slides. adoption detailed high-level QX, of saw me efforts the our pathways transition that will support review for some at believe finished, Once further more forward. to more commercial a which increasing

has our Slide distribution changed. with X, not Starting model

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

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

small million about XXXX. noted, quarter product Alan this This As net third of the we increase. $XX.X estimate There reported was XXXX. inventory contributed $XX.X which a increase increase QX were is million from of in sales of a in QX, in $X million our $XXX,XXX the

launch. note that to of X,XXX which of NERLYNX XXXX, shows On bottles our bottle represents Slide the see ‘XX QX identical this Please We sold specialty you into it end demand. since and distributor NERLYNX sold, is specialty slide of ex-factory channel sales so X, by bottles not sales and pharmacy our user bottles X,XXX. in of almost sold quarter QX

that that comparison. Please QX execution has in growth. we QX growth bottles, focused performance estimate well which on with approximately The both total inventory quarter-over-quarter saw growth we we the impacting team of this enrollments, recall and goal in saw by aligns of commercial about with as for or quarter-over-quarter new bottles. XX quarter-over-quarter increased driving build an QX, aspiration is inventory year-over-year In TRx. XXX been year-over-year that prescriptions, NRx, as both prescriptions, and that

performance. quoting enrollments X% year-over-year additional provide XX% this specifics I’m quarter-over-quarter of comparing QX are ‘XX. Now QX and growth In to let saw year-over-year. of some ‘XX me QX, around The we grew rates

or XX% XX% growth. starts patient we saw growth new and year-over-year to on Moving NRx, quarter-over-quarter

looking leading we’ve is new previously, or total and into important starts influence an and growth comparisons. prescriptions continued about TRx, turn for time which total quarter-over-quarter since about quarters us the well. NRx trend in positive positive year-over-year subsequent NRx both indicator prescriptions X.X% As This seen enrollments, have TRx, for first we refills, at quarter-over-quarter X% patient when year-over-year. discussed This as launch grew is and as

Moving amount on and diarrhea by can the profile days progress believe NERLYNX. X, education of X with clearly to the and median of benefit very a overall Grade reshaping escalation the being of the Dose patients the Slide dose are Grade of focus pleased diarrhea, plays continued role adoption in made. the reducing to have we significantly We rate. of X escalation dose and important discontinuation escalation risk-benefit the adoption

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

guidelines early-stage in In escalation addition, dose include cancer. NCCN updated breast their XXXX to clinical practice

on an see increase can you the As of continue escalation. we see to Slide dose in adoption X,

received who on a drug patients of XX% approximately QX, commercial started in dose. fact, In lower daily NERLYNX

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

We made. for our adjuvant are The the was regulatory and pleased with and being metastatic global both launches and and Ecuador cancer In QX, extended were both and breast approval progress Singapore the Spain. Spain Brazil launched in Brazil in in setting. in officially received partners NERLYNX

global available to the more I on future Our driving with and for continued their forward of highlighting progress preparing patients partners look around adoption are NERLYNX the increased goal world. to launches. focused making

Puma their to difference families making lives cancer. and was battling a on founded breast of the commitment in a patients

colleagues to the We more. their moment patients to I to their these doing better journey. are do the to and the thank more to my determination steadfast exhibited passion make support strength of difference I by Puma and and are many want to a inspired am inspired just commercial and entire courage cross-functional committed organization. by a and take by

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

Maximo Nougues

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

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

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

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

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

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

seasonality decline $XX.X share, inflation to lower for the for was QX sales the lower of Continued are versus XXXX of of million license. drivers XXXX million. high for Medicaid amortization related million, quarter. due $XX.X prior to was main and QX co-pay neratinib Cost including Cost our to the sales intangible assets $X

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

fiscal net be of $XXX in year NERLYNX now XXXX, million Puma the guidance, is For $XXX its that previous range product will increasing million. revenue to expecting

partners XXXX, slightly $XX world our anticipate our year the to than be to exchange for in our the NERLYNX We also due China the around timing prior better for revenue XX% our fiscal negative lower we in XXXX guidance Furthermore, year adjustment license $XX gross anticipate million, full that royalties to our guidance. the net expect receiving and our don’t shipments and foreign in prior than impact. million from of We range will to XX%, XXXX. potential partner between the of

the year. XXXX, for addition, negatively net impact new $XX in million. of be this This revenue. of profile years range full QX will COVID-XX, in impact have seen the $XX sales have in great prior and million regarding as a will QX prior assumes of effect prior also we income to the net We will to of decline guidance of the In that see our $X a $X deal million around may million anticipate to years. guidance in guidance in we range holidays to This the narrowing patient inventory uncertainty seen we royalties in to drug. the that be continues our continue to that increase due starts a recognize as sales, assumes year sequential and license NERLYNX QX side we We there are for

holidays, tend patients the starting delay seasonal in We see which that QX. to patient causes after new in a many until starts NERLYNX decline

royalty to to call. $X explained million QX royalties $XX increase quarter will range million that $X the XXXX increase the gross to will of This We caused during net as XXXX anticipates SG&A of our expenses in of Puma quarter. the the to partner for shipments adjustment expect the QX by in to million. million. in $XX.X and to between net revenue our XX.X% is million be $X further be timing in an fourth is estimate revenue quarter This income approximately XX.X%. $XX for – third second QX were in we We compared prior compared million the QX. China,

quarter million were QX quarter the R&D SG&A expenses for million expenses expenses million $XX.X to included non-cash $XX XXXX, quarter. quarter in stock-based for charges of development $X development the million compensation non-cash payment in-process $X quarter. for to XXXX third $X compared XXXX for $X.X third to for the compensation we million in In for of $X.X to $X.X for compared stock-based compared research the of acquired Research the XXXX third second and QX Takeda. million the XXXX. expenses second charges recorded million reflect to included and million upfront of as

million $XX.X burn compared approximately XXXX. XXXX, of In million Puma of in QX $XX to burn the cash approximately of quarter reported third cash

cash payment XXXX as in was QX the $X Our include October. burn executed million Takeda it to not does

down XX% quarter XX% continues to expenses expenses expenses a More XX% operating to in XXXX cost approximately actions company to and XX% expect to of be of we XXXX. the result to implemented Puma R&D compared to anticipate in be the XXXX, SG&A down specifically, year-over-year. containment fourth As across lower

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

million. Our accounts receivables $XX was balance

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

Alan Auerbach

Maximo. Thanks,

to presented barriers to During commercial team. XXXX, challenges XXXX commercial presented for COVID-XX and Puma’s Puma and pandemic significant access significant commercial

positively. have believe that these continue well, trend this HCPs and to interactions better with face-to-face We as results access that As to detailed contributing are that during we the year, this increased restrictions lifted overall commercial seeing hopeful we as seeing earlier. XXXX, are we are Jeff is will and this increased

senior of goal the improving Puma’s these with believe reduction of positive the in reductions. Directors the expenses implemented a in that reducing quarter expenses focused operating in and XXXX flow result We beyond. Fourth remain XXXX, maximize Board NERLYNX the cooperation in continues direct of reported to of flows. cash management a quarter we sales with order to cash on in was expense

need for Puma The and There company we operational continue updating will their during about other to remains effective will and We patients remain lung helping committed battling reduce unmet if achieve that continue committed to needed at cancer continues this to forward and future. solid the goal. we to passionate cash to to on breast investors this. in patients We these expenses tumors. strive continuing are significant a finding look achieve to to journey, ways cancer, achieve flows, these at and more

This concludes today’s presentation.

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

Operator

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

Unidentified Analyst

for is this Steve Hey, Ed. on

from timing First of question, ‘XX for of half the like the to went so ‘XX. the meeting FDA first looks half it second

explain the was you there? can So change what

Alan Auerbach

Steve. Hi, Yes.

to packages them the ended mutated getting later EGFR HERX than and meetings the for the we expected. the we FDA up Regarding mutated,

of timing expected. that’s the just it’s when So

Unidentified Analyst

went that’s then Alright. interaction – up. live good, so And the

think size? team So live the is the sales you right do

Jeff Ludwig

that right from size pretty we as is key good adjust seen this will the doing the I and improve, the size I we’re if Certainly, good to certainly access across like we’ve the access got But feel force now. and and can roughly slowdown our country. the and years of a we market, moment, feel restrictive field field targets right several Steve, ago. of our a now, believe appropriately. so strategy. we’ve Right the with oncology continues very said, will open the cover force about up market are executing With all right Alan, job work that size, right I we

Unidentified Analyst

taking Alright. question. for Thanks our

Operator

Thank you.

with question of question. Please America. your is from Meacham proceed Geoff Our Bank with next

Unidentified Analyst

Hey, [indiscernible] a good Congrats Geoff good afternoon. quarter. This is for on in calling Meacham. commercial

So question I more interactions first you more to can the color it maybe good Just it what with is going related think Could us drives of to that. or live COVID sort a little my clinicians color Is of back any commercial normal? maybe quarter? give bit the provide? is maybe you

Jeff Ludwig

Thanks appreciate Yes. I the question. for it.

you tell that promotionally a at NERLYNX is is level, I’ll high Just what sensitive.

to is able increase impact. of it being voice and very certainly share So and important an engagements overall has

we leads increased we’ve talked to which As force. our by access, productivity seen overall sales about, improved

the local beginning And going to we’re improving executing we’re targeting that strategy, also efforts their and of have worked a well that the of changed And able not that’s at certainly those have and In I accomplish. that would digital and on social say drive our regional customers organizations. teams advocacy hard guidelines although job peer-to-peer lastly, I’ll we’ve to the throw via our addition, and year. media. trying as engagement our good non-personal adoption, their supports out promotion with on done it to search, not that teams reach our NCCN increased

helps as air So well. us cover it really give some

Alan Auerbach

those to at exactly some would can positive. interactions cancer I is restrictions, which look quarter-over-quarter, etcetera, metrics COVID that were that had you up the COVID they obviously Jeff that, if been going HCP all reduced. if of keep with per is right rep, And and I Yes. restrictions add centers there like say, still have

lot think to the very us we as So feedback question, change including as well. NERLYNX And do that that from well. the helpful get has of NCCN a has I the no force field guidelines, helped been

role, a playing that’s that too. imagine would I So

Unidentified Analyst

to do you you that such two live now Okay. foresee the because molecules And any see so And need for cost, to the resourcing more quick on for you do just then in interaction, resource more the promotion, you better promote? the of XXXX need for develop. R&D, have SG&A,

Alan Auerbach

We have spending a guidance not from changed perspective. our

that and like R&D I with studies we’re and that increase So side, is would of expenses earlier patients studies remember decrease some other especially R&D like would studies the we the our etcetera. on continuing CONTROL, say the on not to neratinib, our less because see there SUMMIT

in down. the of closing We’re process still

those coming are costs So out.

very the it’s other one while I whole down, year. we will of from going cost I neratinib a kind ones think kind to would you’ve and imagine. But the studies a the again, see year, So of going from amount, got this more lot alisertib. going going up, with down don’t flatten, small next the

Unidentified Analyst

you. Okay, that’s Thank helpful.

Operator

you. Thank

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

Unidentified Analyst

commercial for for stabilized? This wondering payer months And like and between Gena. first, thanks new secondly, they is percentage on where stay X are many you to Medicaid? the see our Hi, the through Maybe do compliance split on updates any Medicare, if X Tom still patient how for could first starters, get just taking there the question.

Jeff Ludwig

Sure.

of those address me questions. Let both

again, fluctuates About XX% XX% self-pay. say Medicare, either we this modeling, for would roughly a is would of VA, DoD. Medicaid, payer, from And remaining be the split see or But about I quarter-by-quarter. is First, uninsured also commercial. government, general XX% unidentified

– hopefully that that’s that. answers So

and a length asking, escalation, therapy, just of there. broader of think I of In me perspective uptake the let you’re given you terms dose give

adopt dose First well-received their patients research that we physicians escalation to that additional going NERLYNX of likely forward. are dose market customer know escalation by more start all, and physicians engagement, of is on through the staff that majority do and and

dose label, X. things and dose than dose know by your But question, specific impacted side dosing that to other week just per address patients are our also has know, effects. full We compliance escalation, to as by persistence other increasing and you

of month we expect benefits to month escalation in would and see X. that, X about the dose thinking So

overall of ways is X% dose of adoption are to patients persistence and data us to throughout compliance trying between improve escalation to support currently really dose X seeing benefit important an but escalation, fluctuate, and Dose only decreased increased in through but persistence escalation. journey. month discontinuations does additional strategically, Our X% dose absolute not we’re we or and their by to other about the full

So helps hopefully that out.

Unidentified Analyst

Yes. Very helpful. could have the year. Maybe FDA regarding a discussion I follow-up if the in next

if Just will before with the updated wait to before wondering that? you’re have with biomarker proceed alisertib discussion going from you the the data FDA for you the FDA just or the

Alan Auerbach

be lot in going We’re with mutated proceeding probably we we’re FDA, that small biomarker cell because have for And that have or of the with a assuming going if the RBX have them data. cancer, amplified already proceed example, c-Myc the populations we to the lung don’t data. the after, we it, we still will

obviously can the as for involve having So we have we won’t a on that can used it it from on lung. obviously but other stop the that be discussion FDA for cell small or conversations well, tumors breast. in breast, with us breast If like

Unidentified Analyst

Thank you.

Operator

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

Mariann Ohanesian

joining Thank you for today. us

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

Operator

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

You may disconnect. now

Puma Biotechnology (PBYI) 3 Nov 222022 Q3 Earnings call transcript