PBYI - Earnings call transcript Q1 2018 | Puma Biotechnology, Inc.

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Operator

Good afternoon. My name is Rob, and I'll be your conference call operator today. At this time, all participants are in a listen-only mode. After the speakers' formal remarks, there will be a question-and-answer session.

As a reminder, this call is being recorded. to of conference IR like Ohanesian, to now Director Senior for would turn over the Mariann I Puma Biotechnology.

your begin may conference. You

Mariann Ohanesian

Thank Results and to you, of afternoon Puma's Rob. Call Conference XXXX. welcome discuss the for to Financial First Quarter our Good

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

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

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

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

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

Alan H. Auerbach

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

from we in provide of XXXX, June In sales Chief HERX-positive activities a cancer. on for to the breast and cancer, reported European Agency treatment increase by since been In to-date. a breast who the submitted sales pleased $XX.X who an Puma's I over to turn was have NERLYNX sequential Steve NERLYNX, early we sales adjuvant Medicines Puma's U.S. approved FDA XXXX, stage update of NERLYNX in of moment, trastuzumab-containing July reported for patients XXXX the launch. for have first detail We the stage Officer, early Authorization $XX Commercial which in report Lo, in with million call of grown regimen. represents are NERLYNX with that progress extended commercial of the the Marketing U.S. a quarter for our of will treatment XXXX. treated the steadily Application HERX-positive approved net product, quarter first will previously Today, to million launch-related of the a neratinib the fourth

and that In a the a March, response receive CHMP the Marketing around we as of the We the Puma for timeframe. trial reexamination from CHMP, Products Use, Authorization As opinion, with more forward July Medicinal recommending on known American Annual a We mid-year opinion the for from expect neratinib also Human look previously of requested clinical ongoing specifically NERLYNX quarter MAA, also of negative in clinical KADCYLA, anticipate I/II adopted the reported, and Committee in the to for Phase refusal several Meeting. the in second breast Oncology as of late the data for Society at known additional Clinical to reporting early neratinib. metastatic in HERX-positive cancer combination updated milestones June, NERLYNX. T-DMX,

the In On addition, third-line in breast NALA event trial aware, ongoing slower originally trial last was coming the we was announced Phase rate neratinib than in are lower quarter's continued the much in than as also we to come projected. III investors call, in as has The trial. of cancer metastatic an known we have HERX-positive that anticipated. event rate

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

timing will trial to updates. provide investors in with future this We of continue anticipated

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

statements be of progress discuss turn now for who first commercialization will components or Phase Steve call Eyler, early with and key U.S. trial with Lo, will of diarrhea neratinib-associated the over we who use II loperamide addition, to-date in expect report colestipol quarter NERLYNX. HERX-positive our XXXX. will the on strategy highlight data In by cancer XXXX. involving to CONTROL the breast additional Charles without our I quarter prophylaxis will fourth patients Steve of our stage followed to in from the financial for of

Steven Lo

am made to discuss with the we the of I have Alan. launch NERLYNX. you, pleased progress Thank

and momentum. months are a forward We into nine to continuing quarter We NERLYNX. this look now actively had very strong promoting

my First of be will a presentation, statements. that making reminder all, I forward-looking during

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

prescription FDA services, patients see where X, will quarterly not will facilitate with but helps also since provide integrated be and which physician the pharmacy. results, with net directly assistance provides ability Charles now obtain separate the the financial systems since call, sales health of results support. to We NERLYNX office, and Later to VA. the I distribution Patient and you Puma you In Also, with have from have the to to also patients co-pay in full financial specialty does slide sales established helps physician's reimbursement review their for approval. the FDA approval. offices Lynx This the certain our NERLYNX a channel, need specialty we sent

at being specialty Furthermore, net net in and with from of their through As had of a prescriptions, X Alan more you estimated April's becoming more NERLYNX. and prescribed slide of the increase aware I the mentioned, refilling along net This see growth pharmacy cumulative quarter. sales of of monthly This distribution included the chart month sales. XX% the $XX strong specialty increase an very with have prescribers NERLYNX result channels. million, NERLYNX the we patients was both April, if prior and quarter is of revenue the

specialty specialty slide company delivery. X,XXX receive channel to of means The least believe do represents only our note approximately total growth NERLYNX, April pleased does FDA not strong XX% through data. been from shows XX XXX is continued shipment are snapshot prescriptions. not patient pharmacy specialty of month-over-month from XX, of this process, or through by X,XXX capture pharmacy that their see indicative could have NERLYNX. pharmacy and pharmacies. received a at NERLYNX unit have patients over distribution Of specialty prescription patients in the and volume. From this of is because received demand a new approval scheduling the channel, authorization April a sales through specialty be Please We This those, are prior the awaiting for usage channel the one they which over prescriptions approval insurance we

The see out a patient to encouraged month NERLYNX specialty are to patients refills in to first during and reach actively patients their pharmacies on them receiving provide We also counsel the timely are manner. support. many

XX.X% NERLYNX, this pharmacy reasons pharmacy or patient therapy unique a be for specialty to XXX is specialty travel, specialty another or a discontinue the office in discontinuation. system physician personal we to such rate. could have a transfers is this pharmacy far, seen Because So patients if delays as data, which as discontinuation dispensing classified

events the adverse to audits this discontinuations to monthly or of total XX% approximately half and rate due conducted a is due have We adverse only believe data events. discontinuation the of discontinuations

months where dispensing opened through new pharmacy may will since ratio terms in specialty patients growth can of distribution see be vary. there and see In slide X in We in-office launch. patient specialty you of specialty a first but trend channel, did SP pharmacies we the see monthly up the the April, the channel, and small Since going the are you part recovery seeing The TRxs On dip and of will the already the the follows dispenses as of NRx in X, cumulative at patients enrollment end both slide month. shown to graph. in NRx's a trend. new prescriptions

has every steady to contributed to every result side the patient patients of every or do are tolerability refills, could NERLYNX weeks, improve that lower but which weeks, continued note on to refilling not by five to dose their NERLYNX the of TRxs. drug. six start due see their the Please four to physician stop growth to they but encouraged remain and effects. very told in the are We some This growth

less do a personal of of less, of been company the promote a many delay There also also NERLYNX side continued cancer, are or due of to starting the it metastatic pleased is right-hand such see longer off-label travel. for smooth small prescribed contribute shown process. as patients times the reimbursement a as number days XX small in are that XX market, on XX% of who to sign where patients which and number needs insurance situations which NERLYNX more who There to patients fill receive We the to days to receive NERLYNX reasons choose slide. we have such are or in or not patients These the use information. a

are to are has over patients number practice. last NERLYNX the actively NERLYNX prescribers. number of has since Now, grown The in their onto more Thus, those see QX. XX% we our as in over quarter. and oncologists seeing of grow prescribers, in make that unique XX% Therefore, increasing in we there to target prescribers. to continued continues we progress are XX, depth prescribe now penetrating X,XXX prescribers seeing audience, The you Recall our sales slide September. only force physician both breadth and promoting been in

awareness of penetrated quarter While fully and made opportunities audience with with very launch, patients. especially we to not we are the payers management there XX% and physicians, We physicians, growth their we've our To diarrhea have have since had more more made a progress encouraged still in physician are sales. a highly strong options. increasing reach we net summarize, progress with

We and continue to helping stay patients prescribers receive more reach on their medication. and

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

Charles R. Eyler

Thanks, Steve.

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

XXXX, In I the refer on million or statements. a of be will consolidated which filed reported to $XX.X first and includes our information, loss of tomorrow more that recommend our you a $X.XX net quarter share. based GAAP financial XX-Q, we For

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

fourth mentioned, million XXXX. Alan were versus NERLYNX the million quarter As for and revenue Steve sales from net $XX.X of $XX

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

we also Going forward, as In licensor goods quarter to cost will revenue first quarter milestone $X.X sold. we continue of recognized the of million. $XX.X of aggregate million the of sub-license per payment the to recognize of XXXX, amortization

majority basis, Non-GAAP and XXXX, that for quarter of million anticipate and based revenue revenues and million the includes fourth to fourth currently first for extended for the $XX.X to $XX.X range respectively. fiscal were for continues compared million and the compared the development were for adjuvant XXXX, of indication in be the of $XXX $XX.X respectively. $XX.X of million On million fourth Puma for $XX.X third net were million first to and SG&A fourth were $XX.X Research respectively. a quarter approved quarters year XXXX, of R&D guidance the expenses based from will respectively. XXXX, million. of the million and XXXX, million and on and third $XX.X of to for coming the to $XXX For third GAAP $XX.X quarter non-GAAP expenses and NERLYNX the to $XX.X quarters million expenses $XX.X on only. third SG&A compared first million $XX.X expenses million quarter compared XXXX, million GAAP $XX.X million This quarters

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

ended the by expenses for We funding that fourth neutral, $X $XX We license equivalents. of for XXXX sub-licensees, quarter compared in received of with million was with operating cash continued cash in cash our first In Our of the (sic) cash for and first XXXX a and million quarter. we $XX in will the we subject respectively. anticipate flow XXXX, to million million to of million] term quarter cash QX, transitioned loan our and $X [$XXX approximately $XX.X quarter, two such burn upfront we to the approximately October Per payments the million throughout have burn approximately reduction burn secured tranches. cash our in positive. $XX first agreements million QX cash in flow

replacing million May and The and existing on amount the million general subject in October activities. amended $XXX funding tranche for million new first being of X, loan a $XX to was support term XXXX, loan purposes term loan, with received the used NERLYNX tranches. commercial of we $XXX XX Effective to two corporate is

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

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

Alan H. Auerbach

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

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

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

Operator

you. Thank

now begin question-and-answer the will We session.

Cory Our with Kasimov first comes from Chase. JPMorgan your proceed Please with question question.

Cory W. Kasimov

(XX:XX) questions.

First that wanted one about is, ask in I to reported you some dynamics of April. the

sales also patient month So, best was dip new was this to-date, but in a your there starts.

I rebound I then, but around new offer you May, prescriptions can bit have color said you've more seen in little a hoping think in you one And a this. follow-up. I'm

Alan H. Auerbach

Yeah. happy do We're to that.

rest got coming to an we the line trend and of for week of you know Those new first the was more was some the would that new extraordinarily last dynamic. specialty the if don't reason. pharmacy for up low saw color, due that So, if were was March. into April – I And a any what the back little then or just patient to anomaly with say We fundamental week. I we patients the seeing more were give in a in NRxs month.

Cory W. Kasimov

All Okay. right.

Alan H. Auerbach

not be obviously I to dip. So, be goes. which – it – to whether at say it see would this it continuing We'll appeared to a it watch point, one-time be appeared direction to or

Cory W. Kasimov

regards that helpful. something the rate you the NALA follow-up based study basically on. one And TYKERB I'm assumed pivotal event Phase from quick That's study. curious III else? Okay. Was or then, with the to what

Alan H. Auerbach

trial been rate lot the a will, a endpoint whereas progression-free of see seeing is, confirmed and expecting double-digit in to to the historical months you based again, event we're if controls, The (XX:XX) trial on centrally Yeah. we've and number events of what was survival. – is unblind

the one single-digits. whereas cases that's monthly expecting be we're event seeing in in some seeing were So, in we to double-digits, a rate

Cory W. Kasimov

queue. Okay. Thanks, Alan. back I'll hop in

Alan H. Auerbach

Sure.

Operator

next Lynch. Ying question. with America with Merrill of question Please The your proceed Bank from is Huang

Ying Huang

questions good afternoon. as taking Hi, for Thanks my well.

the We So a more about that, bit you comments, you discontinuation? a half can other detail who can then, to shed on AE. little on give us understand can a new maybe, the due bit assigned was light little But XX.X% tell discontinuation? little Alan, to the the the bit the was – half half you know is? was more about if I wondering we Do that And rapporteur rapporteur reexam? more which

Alan H. Auerbach

Okay.

Steve question, over your other second So, it let one. to I'll the hand answer me then for and

that I remember have we assigned country than from they're had I of different different countries before. and we So, from. remember before rapporteurs MAA. been which for reexamination do a what it's rapporteurs new we the had the But don't

Steven Lo

Great. is question. discontinuation Steve. Hi, this I'll the answer

yes, in pharmacy. your monthly answer in our on discontinuations the So, we to question, specialty do audits

adverse half are of diarrhea. about such only attributed So, as events those to

that other the designate The half attributes (XX:XX). classifications to specialty will pharmacy

a they So, different if specialty pharmacy. moves are patient technically to discontinued specialty at another pharmacy, a

will the as physician's also So, they adjuvant extended finally, very have dispensing a be such office, account then be a progression. and not And discontinue move for patients are they to some discontinuation. will their may that numbers. obvious There reasons for are patients who that of we patients, amount in-office small who at metastatic, will of so

the why are would patients discontinue. reasons other those So,

Ying Huang

Thank Okay. you.

Operator

Please proceed question Kennen next with with Capital Mackay Our from is your RBC Markets. question.

Kennen Mackay

help that X,XXX what currently at also grew from the January about I end step-up forward, that seen a run in we'd on donut any if guess hole prior if about or And there. there's should sort you're as there's we rate of active the to obviously, thank patients maybe with there. about you. the of can rate we that's the from you active, Thank what for gross XX% what then, the active about are you in big be an sort wondering treatment, the (XX:XX) taking update. should new be question. net potential can thinking Wondering you impact bolus to of any in Hey, those given provide color extent color the, the and from Wondering us discontinuation the patients around if QX seeing the going patients again, expecting of

Alan H. Auerbach

Kennen. Hi, Yeah.

So, need third two repeat one and you questions, the to let I again. answer me first the

net know, to gross our terms was in the to And the you're sold. fixed in the payment as in in is, gross you cost goods of So, XX.X%. quarter that's quarter-over-quarter to gross the a net, reduction that of seeing net we have the

revenues obviously as hit And your obviously, of from about Medicare So, second the our is to increase, the Medicare. (XX:XX) down. that XX% terms population cost goes question turning patients, in of

an And I of donut you really then, don't us that. don't know if third tell question? your see have I hole. to if way we again much see impact So, we from any know can

Kennen Mackay

absolutely. Yeah. No,

what of decent something rate – active sort the Just the prior think, the at, should comparing sort prescriptions X,XXX prescriptions prescriptions, going or prescriptions pharma those looking And it slide previously. of increase, about the to is X the sort be XX% in if, there looks we update, of I specialty to that's run from. has from if again, patients again I'm rate active we X,XXX anticipating or from to is anticipating and yellow prescriptions should be of increased a of here out discontinuation it see here wondering enrollments those like number box that to

Alan H. Auerbach

Okay.

a active, discontinuation from see XX.X% because that Not you specialty pharmacy, So, could those stopped instance, of mentioned getting are Steve from rate. be one. getting a one as the of on for drug it you all true that X,XXX discontinuations, you're different number showing the it the that, slide we're

where a could you different will getting it of getting it their situations office, one getting Or you're it now from are instead pharmacy actually but patients, say So, doctor's have discontinued, pharmacy, one. the we from through specialty right.

The is through getting seeing we the getting in-office so what the covers specialty it doesn't So, dispensing. the they as specialty it the discontinued you're distribution, only cover shows data through discontinuation. It this on pharmacies. in-office slide dispensing. But they're call up pharmacy, which our a it

Kennen Mackay

you. Got

(XX:XX). Okay

Alan H. Auerbach

with. X,XXX, the number that to a your question on answer good go is forward yes, So, to

As know is discontinuation the about to of from XX% said, discontinuations Steve about the NERLYNX, you due – as adverse events due XX%. are

like As you – those the they're the tends first to first tend that occur on incidence that to know trials, from drug. highest the in the is month the clinical be

we say a X,XXX So, coming I the number. new have would ones as is well. obviously, good in But

would to expect to continue So, number grow. we that

Kennen Mackay

clarity you. on Got the all Thanks this. for

Alan H. Auerbach

Sure.

Operator

next your Our with comes question question. from Nochomovitz Citigroup. Please proceed Yigal with

Yigal Dov Nochomovitz

question. Hi, the $XX Thanks. where I the Could million respect current Alan and stocking pointed relative (XX:XX), on the saw April those quarter? things where stand think, you team. Thanks Or levels I for to with in are to numbers? in the comment that you out taking

Steven Lo

stocking Yeah. right Hi, launch. The at don't We of whatsoever beginning. stocking part any Steve. have this this occurred is at only the

give We you specialty color the have they me stocking. deal Let some pharmacies, just-in-time and with primarily this. on

dispense So, The our pharmacy or just-in-time. a when patient, once hand. can and within a day the much physician They from this same on offices. that stock don't are gets goes again it XPL they carry with really They they order two. immediately shipped to

Yigal Dov Nochomovitz

Oh, okay. That's helpful very clarification. actually

flow to by year to Now, think, the Thanks. also – estimate on, give and cash us trend can whether over the and pacing the course little with the regard Pfizer R&D of the break-even the down assumed of in how are spend clarity to milestones a bit just will that I break-even? will flow rest reaching more the cash end of additional get to you of revenues year, be expected of the

Alan H. Auerbach

Yeah.

payments I I expect terms So, have increase. Obviously, to any would And of payments this to are quarter-over-quarter. in I there's trend we milestone down year. due down continuing this flat revenues R&D milestone quarter-over-quarter, year, that don't to to believe say would expect expenses would

Yigal Dov Nochomovitz

on actually, two. I the well, are say clinical you just front, Okay. one then, to final have able the And –

Alan. answer to you've NALA quickly, so say far we how that? if – able are going (XX:XX) XXX to study. the you just about assume events generated could relative could Is also where on heard but of And First many haven't if that on, you Thank stands. I actually still anything the that I-SPY and X you, clarify then, much you that's neoadjuvant

Alan H. Auerbach

Yeah.

front of don't that terms of number have in me. the In number of events, I

I want my inaccurate to So, obviously don't be statement. in

So, have back on get the numbers to I what would are. you to

Group that. have of X, handled of – by the In don't I being that they're what (XX:XX), for planning And I their that's stages initiation. current are and not I-SPY believe the I terms in know I-SPY plans

So, I would back that. you need to get to on

Yigal Dov Nochomovitz

you. Okay. Thank

Operator

Ladies and to gentlemen, time for out this we to run conference I'd back have the like turn Q&A. of remarks. Mariann for closing

Mariann Ohanesian

appreciate Biotechnology. We in your Rob. Thanks, interest Puma

As via time a at Thank your of reminder, for this beginning call today. may replay webcast pumabiotechnology.com later attention you today. the be accessed again and

Operator

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

disconnect. You may now

Puma Biotechnology (PBYI) 9 May 182018 Q1 Earnings call transcript