PBYI - Earnings call transcript Q3 2017 | Puma Biotechnology, Inc.

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Operator

Good afternoon. My name is Sherry. I will be your conference call operator today. At this time all participants are in a listen-only-mode. After the speaker's formal remarks, there will be a question-and-answer session. reminder is a recorded. As Instructions] this being call [Operator conference to Mariann for I like the Puma over IR would now of turn to Director Ohanesian, Biotechnology. Senior

may You conference. your begin

Mariann Ohanesian

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

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

over XXXX current refer this concerning Before cause to and during are the our are the the Federal including and and the that factors information website, to from assumptions. subject with like XX-K available annual and that the documents I materially could statements. out statements those turn December the the making year differ may to company’s statements that point ended report forward-looking predictions, and our results risks on I Please Securities filed in the on actual to Alan which affect XX, company. fiscal and to only be of for operations, from for performance described that based which within an call, we and other would the SEC could expectations, time we Form time of conference forecasts, uncertainties meaning overview for Such Laws call are risks to forward-looking

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

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

Alan Auerbach

five-year NERLYNX. is third early arm available who all ratio with NERLYNX will Commercial stage XX.X% versus a achieved Thank the the a and regimen. for with placebo. FDA call and p-value trial in HER-X meeting. X.X of the a in European and recurrence progress rate referred quarter, This of the disease was at you, States. The was Hazard or our for was of NERLYNX today. neratinib commercial over reduction of Phase an presented for the Steve Mariann, in approval a follow-up follow-up Chief and of have the of with for median previously death Puma been presented with the years, thank In treated the iDFS discuss ExteNET call invasive United X.XXX. the was Oncology moment, important placebo the treatment Officer, neratinib I positive the with risk launch in Also breast treatment rate milestone after turn the five-year XX% study, cancer, five-year containing the that quarter results X.XX joining launch data Puma’s we from a the you as showed who of the III to which to-date iDFS will to with Lo, In Society resulted trastuzumab XX.X%. the third for Medical arm and commercially patients XXXX, approved

have II cancer, fourth forward, anticipate prophylaxis for additional addition XXXX. the data we we colestipol San includes several Cancer to budesonide presented on anticipate milestones HERX-positive This additional study Breast quarter from we will our of early with CONTROL neratinib. Antonio Symposium in at diarrhea reporting in or the of stage that Looking neratinib-associated on be the loperamide Phase breast patients which

CHMP treatment cancer. our the use commercialization neratinib known of U.S. Steve the in the Union for addition, Lo, decision receiving discuss the stage third-line the half adjuvant anticipate we will HERX-positive progress in in for quarter to-date results III the from to known extended who the call NERLYNX. I Europe in for first a with metastatic breast first committee the cancer our XXXX, also also as from for of anticipate on strategy use the of trial early application In products we human the in as breast neratinib the will additional of now from Phase Also approval turn over XXXX, and HERX-positive of European [indiscernible].

Steven Lo

am to Thank able you be I very with to NERLYNX discuss this afternoon. you, of launch pleased the Alan. initial

forward We forward. start momentum continuing a are this to off look to good and going

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

during would filled. for starting pharmacy approval NERLYNX be strategy promote in breast clinical educators, specialty which of FDA infrastructure, had the hired we time approach and NERLYNX. and experience already launch information, and field specifically personnel upon specialists, to the medical NERLYNX hired ready other of trained the the recruited, in we and experienced selected field launch XX September. who so with preparations, the identified would fact, channel, and FDA commercial cancer would approval. in over month oncology with soft a personnel This ensure we had occurred hub Our trained services patient in This, August we open the sales sales were be business XX nurse would of that at reimbursement a XX launch two-phase Also be and prescriptions and during actively

executed We fully providers approval. phase now the will FDA actively I early planned are was we you since say staffed since September. healthcare launch as been and also with and the on calling provide have results our our pleased are to second launch of

of On we FDA the physicians patient group Puma inquiries and NERLYNX the received as offices was within into week. second prescriptions days our three drug a known Lynx received were patients physician numerous immediately. to during received able day the specialty and first that drug Patient approval, shift patients commercial pharmacies We assist the first services to We the commercial able from patients. and reimbursement and both within and week

prescription results. distribution not side approximately monthly had through net directly engage when patient of of the the received. six channel allows month the in patients chart the we showing the U.S. patients such note is This a also pharmacy prescription specialty such initial was $X patients management, advocacy What able month Charles sent physician physicians by Our NERLYNX obtain where now their systems the the financial Ion in I and to NERLYNX targeted includes the practice, the the assist slide specialty September, can sales provide as October. who were you patient need HERX-positive of and physician's Later launch Certain nurses pharmacies. specialty In call, have X strategy NERLYNX Oncology stakeholders, and office. to organizations cumulative networks to will to be as directly integrated does a that we July, who make to course, is in direct specialty of to stocking and support review to patient for In channels. through network from all We am pharmacies in specialty and access and have NERLYNX revenue available breast pharmacy. specialty with Please both NERLYNX their distribution payers. Kaiser-Permanente. million of set a patients, effect cancer up who

We patients. specialty initial approval indicative XX, From are prescription data and pleased physicians and initial see you launch the very of is our of by with received strong share I pharmacy is to usage not will pharmacies. the distribution demand capture we October channel, related the prescriptions specialty because during does XXX our the FDA NERLYNX. months been new month-over-month patient sales This growth believe from to data. prescription the and this now NERLYNX do specialty that receive have channel the through only through of not

are see this to the new specialty enrollments forward increase. We look the into pleased month-over-month patient and pharmacy increase to continuing in to network

so been for the our out has weeks, every eight on have about doctor As in breast a not they cancer field. called only sales reminder, force

obtain specialty home. with a insurance As their this benefit to patient will authorization they do The from months, the specialty approval enrollments investigations, conduct patient NERLYNX that then so coming we arrange continue continue to company new to drive the directly pharmacies shift and the in pharmacy network. to into the prior anticipate

medication such also as services anti-diarrheal are Additional assistance, offered. co-pay medications counseling,

need authorization are Although, obtaining have setting, and the to days. is you everyone FDA new patient longer, a pleased FDA pace or insurance in off-label and insurance whose will in insurance and oncolytic that On we a dispenses. NERLYNX cancer and Slide received company monthly more such and processing. days of approximately insurance as small for new in that we Most the less, use to an shipment early because growth smooth we but This patients the prescription for remind see receive at prescribed patients prescriptions very see is we of is seen where approval metastatic is have information. to are prior in is approval and Those tend as be NRx XX not time do and sign the graph. NERLYNX and which I to indication, metastatic our importantly, two number in since dispenses a steady is to approval want NERLYNX refills XX, a to launch, the time that not shipment the cumulative it shown average promote the from TRx oral NERLYNX both that XX use. patients approved a growing

we XXX mentioned, have delivery XXX to of process are prior snapshot from their as in one at you authorization have could means in prescriptions or a approval October the be the on any patients of shipment As patient. XX, scheduling given slide company delivery. patients which a XX, as received they see you least approval will previously the flowing prior I patients to are specialty authorization At from where see those a pharmacies provide to awaiting time, insurance XXX NERLYNX. of

While to patients patient on month first still reach NERLYNX in are refills a very see also out and provide launch, pharmacies the specialty counsel during timely matter. to we early receiving the in actively is The their patients encouraged are it to support. them

an was is XX% tolerability This discontinuation the which So far, seen rate discontinuation seeing discontinuation that suggest commercial NERLYNX, approximately have XX the we lower seen setting seen would the than than ExteNET patients what discontinued in we the rate better trials. in clinical is rate. which trial, in are

including as disease NERLYNX such Importantly, reasons patients this for who progression number or metastatic may is other due to all tolerability, discontinue than patients, death.

to depth month and these we unique Now prescribers, of we are of both Thus, on The seeing in their to as XX. October NERLYNX grown are to breadth number encouraged are see we seeing and prescribers XXX prescribe that over prescribers has oncologists of more there prescribers. patients practice. are month

this basis of adjuvant will of tracking specifically, that speak prescribed are a number of into the to, NERLYNX is every checkup. that adjuvant more prescriber for week is a and in factor coming dose to weekly coming patient are when NERLYNX, well. physical the or Herceptin their the number that believe the treatment that office for when we in coming increase either check finishing for finishing is have typically Herceptin has of candidates are patients been to exams We And each recurrences. on prescribers their patients Physicians to their average continues are who their patient to NERLYNX. a regular this about patient for pleased number or patients last see as We

of practice HERX-positive for one year cancer a translates patients As or per patients, more an breast to XX example, two a XXX physician a in that month. or or

field it of since to the as have in since we our XX% Finally, prescribers, sales reached about has relates force prescribers. September the only been

a to of lead XXX% continued short to We will a in base. able be amount our are prescriber in this growth and confident we will time reach

emails of of Care pleased in, advocacy, patient breastcancer.org, such few. As for patient Coalition, are Young support and a Living we These the availability as Survivors via NERLYNX. organizations the see regarding to Breast have Beyond patients name newsletters to organizations Cancer, advocacy informed home Cancer

As for in of by oncologists name. received a many result of this, NERLYNX we asking reports coming have from and patients

XX% NERLYNX that excellent. insurers Medicaid, so payers, broad coverage More are have exactly reimbursement commercial Finally, what of mirrors and the as NERLYNX’s established in for is is covered Major than Medicare, lives covers across far, insurers. for criteria label.

seen not outright To any We extended sure remain insurance regardless are the we pay. to denials have or summarize, plan patients setting. weeks our all the we the highly access with of have insurance payers, adjuvant of launch, to in must committed for although We to are now physicians. NERLYNX to in NERLYNX ability with making we’ve and the and more continue NERLYNX encouraged patients. nurses, made executed early physicians, according to We progress reach launch of

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

Charles Eyler

Thanks, Steve.

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

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

share. loss of With XXXX, of loss we or per million reported on third a a $XX.X net the $X.XX quarter

and approximately XXXX to million to is million third XXXX fees $XX.X for were and of quarter of to expenses, On a expenses ongoing were of due approximately a $XX.X quarter the Our to net expenses first cost fixed quarter XXXX. basis, cost $XX.X and of for launch increase and is $XX.X that in million, million cost as loss second and NERLYNX SG&A book in and $XX.X the million or $X.X $XXX,XXX in respectively. sales payment NERLYNX million the development amortization increase in milestone quarters Net XXXX related from million second compared approximately SG&A recognize $XX.X for the were quarter compared July. XXXX a $XXX,XXX million for sales. QX Research compared the for million was an expenses $X.X respectively. $XX.X for were expenses will quarter of professional $XX.X XXXX GAAP to staff $XX.X and second based and our expenses of and respectively. million sales Puma's much SG&A was of license On QX up quarter. travel $XX.X respectively. revenue in which each third sales the quarter R&D to non-GAAP product primarily to GAAP a of million the third for the based million for $XX.X quarter Puma quarter on million with second compared and and basis, of related million quarters million Non-GAAP of for to were first cost included quarter with $XX.X in an of The $XX.X $XX.X first million first on and expenses

XXXX million to increase QX used $X approximately compared net the to respectively. million inventory. for QX activities QX increase and million QX and $XX operating in of $XX Our from third receivables Approximately, for quarter $XX was represents of million in this cash an and

$XXX respectively. marketable of We to funding the cash million a approximately In ended in cash into loan addition, we we cash XXXX, of $XX.X of $XXX.X burn quarter two million This cash, a million for $XX.X $XX approximately a tranches. term resulted burn QX October options. the and compared million the cash In stock QX secured for subject received third and million with to equivalents quarter securities. in exercise third $XX million from and a employee of in

received used and general which XX was for million commercial on purposes, support be corporate October $XX will of tranche to activities. first NERLYNX The

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

Alan Auerbach

Thank Steve. and you, Charles

third began U.S. option disease early NERLYNX risk of With we recurrence. of an their patients HERX-positive launch stage the to breast providing cancer additional approval reduce in quarter, with the and

that activities We look And patients, during our the we from launch. This have of remainder initial to are execute pleased prescribers we forward with throughout the and presentation. beyond. continuing to and received the today’s feedback payers commercial XXXX, concludes

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

Operator

Thank you.

We [Operator will the question-and-answer now Instructions]. begin session.

Please Cory with Our question. is from question is JPMorgan. from your Our Kasimov first first state question

Unidentified Analyst

guys. Hey, the and This Cory on my taking question. Congratulations for is thanks Sean quarter. for on

the there prescriptions this to likely the point, guys are comers data early community to more say be more of So, relates in behavior, to any population others are for can positivity? percentage are trends guys prescriber all setting as it say to than prescribe that maybe there And the from receptor of coming to more you are can what regards groups academic any versus setting? example tend that that at you to of kind point discriminating

Alan Auerbach

Yeah.

mostly seen setting. community we’ve in NERLYNX So, Yes. the use of

I prescribers where think majority of the are, think definitely XX% I of or we’re the where them know the that’s and uptick. that’s you seeing it’s XX%

negative, hormone we’re receptor or In the it etcetera, terms hormone across board. seeing of receptor positive

physicians certain label, in comers. seeing also patient so treating according we’re ITT using seeing basically, it the just groups, but just them definitely to We’re according some all the to

Unidentified Analyst

ExteNET looking seems were in trial, there and the bolus on? couple kind and in treated kind that at to I’m launch, are Great. it Herceptin were there July your beyond that in post how group further patients have treatment of last affecting sort the insight some were the numbers of regards I included group of in to higher guys And trying this the in of of do just wondering just Okay. that’s years’ you out out of far initial just so were going two that if of months so Thanks. one, these that kind in some many maybe any were of that if of figure kind

Alan Auerbach

Yeah.

be that it look we three groups at can treated So, patient as there’s NERLYNX. with

One of and NERLYNX. the Herceptin onto they’re they're where XX ones, being months XX directly their months sequenced coming off of

the ones checking once the physically when that's time. and months second their in that evidence coming year Herceptin discussing a know months completed recurrence or ago any perhaps with at doctor physical exam adjuvant the are doctor they're where them is ago and group six you the where for is six The of every them NERLYNX for they

The third wants are the exams. ones coming Herceptin not to perhaps in They for completed four that their the where another you more. where And physician patients these adjuvant are years ago or know that's discussion physical again, have. as they're frequently

have cetera., calling are yet. that back certainly number know, heard you a especially them their physicians from et ago, I patients, years We four see of indeed to we start if years from ago, don't five know that

buckets, are the we months, months to it in Herceptin six know patients go, three adjuvant think coming nine which and may I off those seeing months, directly finished it is have first the who you two et cetera.

think out continue well. ones know I the penetrate So, from you as further to and two then still to have that we those also

of you July, in referring that described of terms terms it bolus that initial the sales just stocking. most bolus the you're to was In of as in

initial just million about as or I the was $X so we stocking. which had Steve mentioned, a think

$X at about monthly million, initial $X So, if that the was little know a in net million you just July look the of over stocking. you was

seeing probably you were September, I pure sales. through August, driven through demand worked in off that pure think demand October know probably August, you So, itself

Unidentified Analyst

congrats Great. Okay. And Thanks. again.

Operator

question. Suisse. is Please state questions. Credit Our state from Please next your question your with Young Alitalia

Alethia Young

expectation last world with loperamide, number far. that’s regimens, couple what the about that? quantitative in I you or Hey, of then on do the my just had little on so -- guys. you a is tracking A I management Congrats for One, metastatic? they question seeing about Also other in think the question. What have you using little if taking talk the from using a were you color diarrhea talk the you are should net, be? Thanks. you're gross to that, and like at progress for me. a or anecdotally And Thanks can any they what can my real the that missed script. can percentages are bit give kind

Alan Auerbach

Thanks, Alethia.

Okay.

our net if mentioned know in On about his gross that I don't gross is to the – to net Charles speech. XX%.

if he didn't. So, I apologize

Our to is gross net XX%.

X% of In terms the who are metastatic, the patients percent it's patients treated. of around of running roughly

patients indication adjuvant. of definitely it's and are extended the So, the in of the majority the minority the

of and there's In then using who if your they're hear of some hearing are insight. very some are or starting unfortunately which exact them track we we have anecdotally medication. loperamide/budesonide, question, that, real regimens budesonide are don't docs We're cetera. so kind manage them terms are of what with using of any as to don't a colestipol in saying diarrhea is using last loperamide, others et rescue combinations of either the good diarrhea, that physicians terms really loperamide/colestipol that the We

we Remember as regimens So, community, in solid we're these don't breast also get well. of the other really a treat docs using. that treat they the tumors just don't cancer, lot that exact

So, things they and lung they treat treat or like cancer can that. can colon cancer

in lung have and management the the used cancer, In and patients to colon prophylaxing treat Camptosar the cancer loperamide, that probably or helping aggressive is of NERYLNX. can be in like treat irinotecan, you there cancer with can knowledge is diarrhea as with that. they very things they quite color So, frequently, know, you so

similar that know, which from called happens On is characteristics has fact cancer to front. the neratinib, drug X in diarrhea side, an irreversible oral lung very which neratinib Grade know you is that that's Boehringer diarrhea a afatinib similar the a pan-HER very to it's Ingelheim Gilotrif it's you inhibitor up believe I

docs probably diarrhea which knowledge management probably the of that have of with helping I the So, again is managing the with NERYLNX. think

Alethia Young

potentially you that? comments, world, that And the he was then if just unpack just Steve's better saying wondering can a real in know, Thanks. follow-up know mentioned he in I to tolerability you that.

Steven Lo

Steve. is This Yes.

in commercial setting, pharmacies that have understand specialty place. in we So, the

patient also call the it's the their practices, into will a finally in take on as the as patients soon as so nurse educated great the educated community reminders. follow-up pharmacies that remind well, so, is things nurses these medication to and practice, calls the the the medication, to provide -- specialty the specialty managers our In also and patients prescribed. And pharmacies we've loperamide have if nurses and with to before then such they're to text have instructions And on they're adhering the believe medication. as ensure

Alan Auerbach

was And probably to or Alethia, also they know discomforts. patient like request, I due had have in to was some diarrhea realized the to it neratinib X% X% who due XX% taking in perspective, range XX%, due or from a patient ExteNET, may meaning to other discontinued diarrhea, just think somewhere you numbers like the patients XX% GI believe of number of I

XX%. all like So, it as somewhere now, at that discontinuations Steve XX%, were we’re in in, mentioned, you XX% Commercially right seeing know range.

to lower but early, – appears appears this, what that again, in we’ve be it monitoring accident. we’re appears it’s right So, than – it now seen

Alethia Young

Thank guys. Great. you

Operator

Our is with Yigal from next question question. your Citigroup. state Please Nochomovitz

Yigal Nochomovitz

Herceptin But give Congrats number the sales. you first are EAP here. of per there the bit reflected that folks sort of be have to fiscal planning any date? rollover then wondering if of in is using numbers year lot numbers the since and a a updated Second, out of XXXX just few And I’m quarter adjuvant that States, Alan you revenue reporting? United third are I one, guidance? a in year are think XX,XXX commercial the are the program that one Number funnel I patients patients Hi you in the on team. might think the just one questions Thanks. were more overall in on the of for the NERLYNX. market, A

Alan Auerbach

Hey, Yigal.

through go your questions. three me Let

expanded did of try we patients the the all, the had anything on – to access program first not convert do commercial to over to EAP, in supply. So

try You think over, didn’t into I and lot to don’t shaking Steve any over. I we of supply. we really six a have months had anything ago converted know or in no. came those is who them so don’t have to had force we any converted head that do know commercial patients

did So, experienced give Once launch no we’re we do with may guidance, with more continuing to guidance revenue the the of sales just we quarterly or not in the EAP. drug your either we get early On through regarding a guidance to annually. that are later providing for them year XXXX. date, any any a that the point. we're not but fiscal getting give third obviously that for fourth at we'll If quarter, or at for we this we're communicate not the change any second we not the XXXX any giving And little the investors.

if your from Regarding of recurrence at Adjutant patients percent to patients the that of have there the probably one on it in the trials number know any a XX,XXX Herceptin The The is which do is curves question number year. look last best only go you would who you with. Herceptin. the adjuvant first caveat I of disease make that is

low think high it's and very it's probably the don't you to So, I mid-single-digits. in probably

applicable they percent three, static because obviously You whatever if just take whatever five recur that the that wouldn't be management they become probably and to population. need -- to out four, success

Yigal Nochomovitz

to – sir, follow metastatic, mentioned? we XX, actually those do the just in then if senses one All And that what that have Steve any do Of other right. that as of up. discontinued our And percentage I you model. things could were

Alan Auerbach

X%. cases, is than think, less was a Dale I he only business as mentioned metastatic the again few

say it once I lender reflected can are that number. that in certainly metastatic but you So, discontinue to

Yigal Nochomovitz

Thank you. it. Got

Operator

Smith Our question Michael from your next with is Leerink Partners. Please question. state

Michael Smith

and NERLYNX on the questions, market, on thanks congrats taking getting we for something Hey market. guys, my that

other of seen as cases, free is of space launch? that, in some or handful patient programs been drug encountered XX% Is assistance that as a that drug something XX% by that, with far oncology we've in of, to companies the that giving away Something launches you've covering sort much so demand. the in

Alan Auerbach

Yeah.

do So, that. we patients and don't who them With regard with drug, have provide therefore, you do for insurance Michael. question, free indeed thanks your know, to we

-- as seen So only XX%-XX%. of patients. I've like other well, aware, It you've that's not number the companies far, to about and seen been where that them has X% I'm up gets

have We X%. now that about so population, seen patient in it's right not this

Michael Smith

Great. any Do is sense much population Medicare/Medicaid? your any, you have target of of how patient

Alan Auerbach

XX%. About

Michael Smith

balance that be question I Can milestone Okay. on they are potentially payments, milestone relates And, those the this Perfect. due? timing amount Pfizer and information to when point. sheet payments have provide just Thanks. are and due you going the at actually some a of some to

Alan Auerbach

Yeah.

you certain the that, onetime is they're upon would Pfizer. you regulatory that the assume will on sales regulatory would they can when approval paid also you there any thresholds guidance can assume paid That in be there then on would indication once those we milestones, territories any you not when revenue the when The ones $XXX paid We've know, how be milestones. the to various payments approval upon guidance ones based that public or our So, are get can paid, hit are payment. be them, a imagine there’s, in much countries. and includes, is we given be and or there's milestone approval regulatory sales in certain million

your to you expectations. know, So, manage own that can of you kind just

Michael Smith

the Well, launch. question Great. on for and my thanks taking congrats

Operator

Cowen Chris Our from next state question and Please Shibutani question. Company. your is from

Chris Shibutani

the Great. very questions. Thank prophylaxis doing you're in regimen. work One, on much. you the Two that

a a are timing the update European additional said quarter that filing. the submitting was in You underlying Have so, regimens? And information said also for submitted it label the your we we'll in European that you in when is U.S. information first of see you to San and U.S. include might one and gating as if that if at Antonio factors see update and the label sounds the to some more data confidence that you those that

Alan Auerbach

of or Meeting. or they San colestipol which then – in data of at back will questions. the can the for our be recommendation quarter can be CONTROL the EMA their of or take that us the list Antonio will will be from data questions. the So, more recommendation updated issue the will the oral the hearing, as either Breast approval similar to respond patients include XXXX it to another CHMP Once of FDA’s the an submitted part EMA, for response first approval response will version send a XXX-day to ODAC to they not is a will specifically. and we Cancer It XXX-day to in to That be arm they

our We that, XXXX to label when point that an investors. label and that updated clarity sometime the on planning at occur submit to to get we’ll better in communicate with are for some FDA that probably currently would we marketed

Chris Shibutani

a with potential I approval we’re question U.S. optionality or think a partner about Alan, into on you logical as deep opportunity think thinking the your us scope well obviously I I as partners the to can that plan where thinking you Update ask sell drug your of be European with And enough for path, the previously would commercial strategic thinking, about Q&A strategic worldwide sales, regard Thanks. other the including to this options. the in U.S. or said

Alan Auerbach

Yeah.

mergers and or discussions regarding provide the or strategics, partnering any with company acquisitions. So, guidance doesn't commentary

Chris Shibutani

Then on the outside U.S. commercialization.

Alan Auerbach

the in is I of we obviously or if day that it. with we be of decision decide but is not investors. best think part making we're U.S. make the of commercialization, options. ourselves. when we selling can we is do we'll that do to decision, can to another Today it have the three the partner entire take company that choose we One company would One interest it do of path the one Outside

Chris Shibutani

for Thanks me letting the ask question.

Operator

is with from [Ian Bank of your Please Our next question ask America. Hanks] question.

Unidentified Analyst

confirm the can Alan, specialty you that talk a you then taking provided the and question. now? you have is Thanks numbers big do about slide for was is secondly, more can you bit from coverage in that typical co-pay a deck how channel, little formal channel there Good the on other a earnings any just do you might a you status, the better access, formulary patient expect what's script coverage pharmacy and number? tier in terms Hi. of if And XXXX maybe have the in afternoon. all for

Steven Lo

is I around channel. the questions formulary your Okay. Hi, what’s this status, regarding question as – take as Steve. specialty well pharmacy the will outside your

talked now, distribution they office in the business So, either the the Right we in of receive channel XX% specialty physician. greater can of our as the in NERLYNX the remarks, about channel or specialty I pharmacy in specialty my have are patients than where pharmacy channel.

you model channel So, is to small say fairly I were the that. specialty if would distribution

of competing displace in product really it’s is it. formulary Secondly, oral that this not terms remember another an status, would oncolytic, with

the no really isn’t around status with formulary it’s And extended prior co-pay. we ensuring stated the that in problems question So, here, the authorization. I’ve your as reimbursed before, game the clears setting. with getting NERLYNX adjuvant was payers final have the product And had through

case in we we most is, So, their for patients assistance we’ve in other to $XX patients successful of to found getting one And of pay co-pay. have patients on of very that see that reasons have drugs on commitment And done the program patients this companies, these our we been more XX like where days in the and with NERLYNX, why no or their you things a co-pay access – is help less. that getting one than co-pay. patients with

Unidentified Analyst

you. Thank Great.

Operator

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

Mariann Ohanesian

We appreciate Puma in your Biotechnology. interest

This a replay for Thank webcast again at a beginning accessed time of attention call be reminder and today. by you an about in As the your hour. may pumabiotechnology.com

Operator

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

now may You disconnect.

Puma Biotechnology (PBYI) 9 Nov 172017 Q3 Earnings call transcript