CLVS - Earnings call transcript Q2 2018

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Operator

Good day, ladies and gentlemen, and welcome to the Q2 2018 Clovis Oncology, Inc. Earnings Conference Call. [Operator Instructions] As a reminder, this conference call may be recorded. I would now like to introduce your host for today's conference, Ms. Anna Sussman, VP of Investor Relations. begin. may you Ma'am,

Anna Sussman

afternoon, XXXX welcome conference Good Oncology the second quarter call. everyone, Daniel. to and Clovis Thanks,

You should website have financial results, received the news not, available release it's on our at if clovisoncology.com. announcing our

Pat may President will today's this several conference then Clovis' weeks. the Q&A. of Muehl, Finance remarks, Patrick closing provided CEO, website being webcast. our Accounting on As financial in a call in discuss follows: for corporate in the we'll will update then Finance and be call our detail. Mahaffy, call the Principal live Senior today's Officer, and the reminder, accessed the next of for make news is available will recorded President a as for The is call components and release; cover and up agenda the quarter Remarks results Dan few be Vice will open and during for our Clovis' second and archive greater key

we securities All Before within to a business. the expected financial plans. actual that of with review risks Please and call, are associated conference in statements regarding, meaning for the forward-looking materially today's federal may outlook during the make with including of me, uncertainties refer filings we uncertainties results concerning forward-looking statements statements business the excuse and our please subject these our to could and full laws, cause begin, from that note SEC the the statements. differ risks to those described our recent

statements. no Clovis revise they as are statements or on and date forward-looking update to only which speak Forward-looking any obligation undertakes of the made,

today's financial Required be found adjusted we'll non-GAAP a conference this today's related on news please discussing to can be measure, that net website. our which in are Additionally, call. release, loss, disclosures note during

Now to Mahaffy. the I'll call over Patrick turn

Patrick Mahaffy

ovarian joining launch us setting cancer I'll Rubraca in Thanks everybody. begin following all-comers recurrent U.S. population April the this approval. the of an in its update the FDA Thanks, on Anna. afternoon. maintenance Welcome, for X with treatment

are required our population, be you for earlier no this indication. expanded line biomarker this into testing recurrent maintenance indication aware, in and all-comers As patients to and Rubraca prescribed there is platinum-sensitive

was the we potential upon we with second launch label immediately line data team approval, entry commercial in market cancer The confident prepared well and into growth, of our and this and are thus Rubraca receipt ARIELX the Our continued for in maintenance the pleased for ovarian Rubraca's position us far. to are indication. the

earlier-line XXXX and we $XX.X net With million. quarter of the all-comers of achieved second addition sales indication, the

news cancer patient oral As in commercial release, quarter This as patients, reported the be the This X assistance noted in in the value approximately overall new our eligible what supply Part space. the slightly represents first least at Medicare commercial ovarian D the XXXX. through of include of $X.X for not seems drug to primarily does the to supply, XX% million through quarter provided up free oncolytics, normal patients program. from

to mid- drug of to the foreseeable supply for future. delivered free assistance for patient continue XX% high the program expect our in range We the

label, quarter-over-quarter our for increase substantial sales. in of a saw result the a we As more time new quarters, few in our the first

have moving the first time limited prescribers earlier Rubraca Rubraca. are beyond X/X had treatment quarter be more over Importantly, with the of in and second pleased those in we experience just our were to Obviously, setting. prescribers who of prescribers,

choice to as progression-free the the PARP drive inhibitor we to course, more. to sales line maintenance To year Our for Rubraca continue approval are XX% choice that survival also Rubraca in positioning maintain sales, fully the into of to among inhibitors. job, or two the best approximately in patients. the PARP position XX% setting going to is gained ovarian eligible preferred recognized PARP of of by remains penetration a advanced all second the this This to class having ovarian cancer. cancer increase PARP inhibitors is have as in on despite We inhibitors setting

approximately maintenance from not despite cancer beyond one monotherapy to therapy a The of all-comers' PARP of As at placebo Avastin either third data taking patients approximately maintenance demonstrating line or receive still compared one inhibitors, maintenance patients, encouraging get now, all. inhibitor maintenance, PARP and outcomes still second do those of platinum-sensitive Avastin sets remaining patient third the very multiple ovarian setting.

fully and PARP sales it in evident are class, the we While share group prescribers, advanced PARP the ovarian, Rubraca potential beginning committed in population to increase for realize PARP all-comers order we must of is for of our eligible share the gain inhibitor the us, class share, dedicated population. that from increase prescribers patient including the Rubraca this in of to to in number

care expected, price a than also inhibitor clear of establish lower the While penetration is and to choice and these has path and an us no Rubraca patients. a provides it rate opportunity standard for demonstrates emerged as as preferred that PARP

the to We of are well-positioned best we with market now to any expand PARP data be label inhibitor. what this believe

As both its the recent and of quarter. second U.S. the evidence, payer the of provider-based the pathway Rubraca indications received end from largest for the sole approved in recommendation for

recommendation notified treatment-based week, States. a largest last in we Rubraca In United the pathway addition, were from that the just received

opportunities. the safety goal review in typically clinical framework to The those efforts oncology and care. recent it the to choices evidence-based case. article in both help community patients clinicians prescribing case and favoring population to two this academic pleased three to organizations no cost-saving and useful an pathways pathways in to of clinical a are of oncologists these create prescribing cancer help endorsements. data we that one aim to focus options of the certain available stated, recommended possible, seen in clinical to committee Combined, evidence a inhibitors enforce, up-to-date when their to to other broad review strongest one where pathways emerged settings, a devising a And all choices and for Pharmaceutical protocol. complex the of Rubraca As in These present pathways the of each and the relates in as standardization amount sole pathway option the available us, opportunity have as Clinical cover make PARP the in indication. for Commerce is efficacy, these sense to surprise evidence have

or of a the authorized now progress a Let sensitive, submission May, year-end primary in less Europe. BRCA was six-month in discussing Very me its turn patients familiar note early treatment platinum to approval authorization improve important by to review formal Commission line-related which in Rubraca the high-grade maintenance of potential as by their EMA of more the for based cancer processes, the under authorization early ARIELX, marketing We submitted or maintenance the and treatment is on opinion the European active upon our all-comers indication, who population a with epithelial was for after approval, to It's fallopian with lines XXXX. the with Rubraca receipt monotherapy adult reviewed second indication here that In prior ovarian, regulatory first CHMP on platinum-based relapsed variation to XXXX, European review. with for mutated, anticipate validated Late platinum-based were tube progressive, by second now at and directed soon peritoneal the we July have the block. receiving the chemo. indication for been or unable two broader a chemotherapy those tolerate treated treatment to through

the we all-comers benefits review rapid itself, the maintenance approval the indication. of Rubraca Beyond indication treatment that the treatment for pleased are a enabled

XXXX in our countries. European out build to majority will continue approval with actively we launch. coincide including planned we're sales individual of And teams. commercial hires, an timing, early this for planned reimbursement Given the medical the affairs the Obviously, and reps, preparing

hires and majority early new As occur as of in the XXXX, any XXXX will meaningful a revenues. Europe result, with in

in chain Of course, safety, the and our supply quality already our were office Cambridge UK. regulatory, teams in place in clinical, in

more are patients expanding the been additional an for XX have allow initiated result than program in available. program. uptake, ovarian a is to treatment treated therapy early now in as a for European until rucaparib rucaparib We have recurrent under countries limited to countries. time cancer drug of And of access this rucaparib the number European need as we in maintenance patients the Already for access into commercially and access

tumors and or during or first-line patients Squibb, whose III this in chemo stage The the the ovarian in now Bristol-Myers a are newly Let study, with ovarian similar BRCA-mutant study Phase cancer, approximately this cancer second confirmatory open advanced platinum-based a I'll lines down two development an more who clinical high-grade with This peritoneal The treatment progression-free maintenance III/IV turn of all-comers with to statistical population after study plus patients ovarian, patients, Phase is is for is study treatment placebo tube evaluate endpoint Rubraca, which chemo. of ARIELX. X,XXX fallopian primary in Opdivo with is of development. therapy. part with Rubraca setting. program diagnosed collaboration in cancer clinical Clovis-sponsored setting, for begin have me our step we completed will which conducting have quarter, the ovarian cancer Rubraca plan cancer and ATHENA the includes relapsed The confirmatory sponsoring ovarian. of initiated III survival. to randomized our Opdivo; study and Rubraca study, This enrollment. study multicenter, progressed ARIELX versus in is primary ovarian with prior

We conducted association with the to in and is the with cooperative more United two Europe, dedicated rapid cancers gynecological groups in in States and in largest enrollment Europe. which study GOG will this ENGOT of the are Importantly, facilitate the the in trial. U.S. this believe treatment

as of in months. earlier X,XXX combination GOG example, the to penetration clients by front cancer cancer, the XX to opportunity in the recent I expansion and line an agents. ovarian expand Equally other Rubraca As into additional evidenced indication PARP is monotherapy cancer. both multiple with opportunity the important, expand study in class about spoke patients in recently breast enrolled the of ovarian in the the a in and just tumor

in on cancer. the in the to We prostate the term opportunity short expand are particularly focused

enrolling We that have two are Clovis-sponsored trials prostate actively cancer patients.

overall patients castrate-resistant BRCA-mutated, our prostate TRITONX, are response two to study, receptor-targeted measurable with BRCA prostate who one is an is in to deficiency, chemo believed for after II radiologic progressed cancer. tumors open line Phase including germline/somatic taxane-based castrate-resistant rate study. endpoints in of and patients of a therapy also support supplemental this evaluating is PSA with trial repair DNA mutations associated labeled other designed in approval genes be is successful, response deleterious metastatic, disease. TRITONX with planned submission accelerated rate androgen TRITONX of The the have an response or NDA patients If single-arm patients The measurable disease The lines who's trial in a without metastatic ATM. have in first setting. a mutation, and primary in Clovis-sponsored single

We take a was in are discussion, data be XXst, to this I'm event forward initial at from accepted pleased to study announce place investor poster the will in which presenting analyst will that as looking Clovis ESMO October. in Munich by Sunday and on later evening afternoon, October followed Munich. abstract that

poster with mutations of the date, on For cutoff who data are of expect enrollment patients than discussion, enrolled including BRCA. to mid-April XX than patients more we more the present as XX

patients All to BRCA have majority of be of XX population least The PSA overall approximately for evaluable response. will also a a patients will XX weeks for be of expected response, the evaluable at follow-up. these RECIST are and

been be I follow-up the patients for also for RECIST earlier PARP it described the have for It's will of October date XX. the composite reported minimum patients, endpoint you, other than that scans. follow-up. poster weeks, endpoints, than BRCA inhibitors this on prostate the and we cancer numbers all to provided. in population on patients, majority shown which is I've the note used responses surrogate that given cutoff to discussions while abstract smaller just XX have largest For more of be advanced represents the or important clear, have number based enrollment of will understand just will response. given for the abstract the mutant abstracts BRCA X the will X publish the make The patients We To months

currently that we As of prostate accelerated positive, such, believe is to Pending for castrate-resistant set we expect data response TRITONX, as an metastatic NDA Based an from and RECIST FDA supplemental of the for data be the we approval the PARP think end used if for a Rubraca supplemental for the could this basis supported important class. Rubraca response of submit BRCA on the use mutant XXXX. NDA by and data. cancer. PSA data, to support input,

and a selection includes that based is received Rubraca physician's in BRCA patients therapy castration-resistant on no have who The Eligible progressed germline is choice those as patients failed The a This result and to metastatic cancer. an confirmatory with potentially survival. study III X have enrolling This as or Rubraca or TRITONX an study, radiological population, Phase or HRD prostate study X comparative mutation, recurrent of so accelerated Clovis-sponsored data study Phase bladder designed is is second prior AR-targeted Our patients the study a ATLAS is randomized TRITONX, will who have therapy accelerated of study on or support setting. ATM status. study are study approval. compare not is chemotherapy therapies. study progression-free currently in II in potentially a all-comers open-label endpoint AR-targeted single-arm serve somatic monotherapy approval. Planned who metastatic this yet could the primary chemotherapy. to tumor And

study, particularly the which approximately for this therapy recommended studies. the of now about enable Phase of hopeful HRD, Japanese global potential Rubraca Japanese of platinum-based X/X identify the dose PK cancer that in or strategy in is to with and Given planned ongoing will RUCA-J of patients, patients fact endpoints, and safety development we bladder bridging Japanese enrolling the study is The as our inclusion are responsive Clovis-sponsored patients. I are in seeks indication. sites that to primary in potential rucaparib

as in the study in Our wild-type is well of in Phase combination to and multi-cohort II patients cancer advanced year. the relapsed of patients as expected the Rubraca begin metastatic This half with with BRCA study is newest cancer. Clovis-sponsored planned ovarian or locally study Opdivo open-label bladder this evaluating second

combination and I/O We specifically. results Rubraca are well aware PARP and of for the broadly, inhibitors for and robust agents desire see to Opdivo

which Phase additional ATLAS from BMS. part The III in conducted advanced will study potentially study hope with and BMS. BMS prostate collaborator-sponsored study later data expected closer cancer a end which is breast in the There that the Bristol-Myers II study trial get design And Rubraca, date of XXXX, BMS-sponsored towards between of will two be sponsored We and are collaboration this bladder safety initial and of preliminary to are combination now and study at and efficacy initiation. in arm late a I sponsored to will data of Clovis by Opdivo pleased an studies the describe XXX castrate-resistant be clinical next studies. with previously. and going triple-negative in a to There study study, ATHENA have that the in to Squibb The beyond Turning the this metastatic from a is to by patients are study mentioned cancer, year Phase initiated is evaluate patients. cancer. prostate being conducted total larger conducted as pivotal

these the biomarker Importantly, negative generate HRD combination relative prostate and of BRCA, the in patient benefits populations. enrolling is patients, on and data distinct preliminary will the study which identifiable

with collaborator-sponsored look to and over for or trial treatment announce a triple-negative the collaboration or novel Turning me as in of types combination continues ASCO sacituzumab pronouncing of to combination or monotherapy cohorts The to Rubraca, wrap and study, is TECENTRIQ, variety Rubraca their a on therapy Phase planned for Ib collaboration clinical Rubraca cancers. you our combination patient were in cancer a pleased approved name. evaluate ovarian cancers. patients. enroll additional trials, To investigator-sponsored atezolizumab, in development tumor triple-negative in are June Genentech that the and up to underway. enrolling update the and better XX now immunotherapy, to therapy at to collaboration of We govitecan with clinical as breast there studies forward evaluate Immunomedics and advanced urothelial it metastatic this We getting progresses metastatic breast updating

for lung were Now we in said receptor factor Servier, where X, Lucitanib factor of in Servier platelet-derived X reintroduction. in vascular with lucitanib's these beta forward potent through a The activity development Servier rights. except endothelial breast in inhibitor lucitanib our growth Japan, to and minutes few tumors. with hypothesis have and FGF held that of growth activity subject discontinued XXXX, was Lucitanib little In insufficient a receptors lucitanib. through and a oral cancer to and of XXXX. tracking about where receptors studies U.S. the recently, established lucitanib on based worldwide, beta, partnership driven we had from evaluated in was a partnership PK alpha move program the we X fibroblast rights is factor growth X. and Until gained receptors of early

that note us. their we return would to that Although meant expected to Servier rights

in studies We of Recently, and a compelling no also planned. very being in PDGF, development we later our lucitanib of and of this pathways VEGF, of inhibitors drug PD-X later LENVIMA, termination PARP on a of or in inhibits hypothesis of study inhibitors intention similar a there from combination represent XXXX. the notice alternative is combination. combination than These QX for a combination year, been have China, of lucitanib. lucitanib that discussed rucaparib, data with data hold termination to VEGF these study will X for now Each in encouraging expected PD-LX. FGF and initiate global Clovis-sponsored based in We've formal encouraging validated studies with combination data a with is And effectiveness a to upon the excluding a have lucitanib Servier received called very and rights, to KEYTRUDA. lenvatinib, or receptor the same expected initiate

not of composition we matter the depending preclinical first on on an until of X X will the patent protection website. of and Hatch-Waxman visit for Events lucitanib, of additional overview please years in and U.S., in U.S. approval. the For does lucitanib XXXX potential data extensions The our similar. the the an expire updated the EU U.S., with or page Patent extensions be expected Presentations in

the lucitanib enthusiastic additional lucitanib over the on these data. of in very for for look forward year. course We plan clinical studies development, remainder the about are potential sharing details based the of to We in combination the of development

an of we importantly, We've quarter reached to agreement SEC Lastly, XX financials us to to reserve when SEC, our this the you'll that related to behind turn note enable and needs in SEC its by a from call final. years terms the to a by will principle, in That the investigation principal related still first that put with in resolving chapter approved the lucitanib disclosed of filed, that a the settlement, and million over couple two us. ago. I before be Dan, settlement, and we a court federal before booked approved

SEC's cannot I So now. neither the nor deny settlement details all allegations. be the But that in can give charges I which tell you the on we would you negligence-based admit

As Part against settlement, no there capacity Clovis a This of to Hopefully agree refers and needs securities part by officer to but resolution concern in allegations violations board. negligence-based member that final. continue Clovis to the investors. are a or this SEC has laws. of which removes the million, federal be will and I uncertainty and that President deny, standard will laws. also our directly and of will I CEO before civil proposed matter or penalty admit will agreement caused my There as to director Clovis several and would this any and me of future service against as President. $XX a proposed over with pay bar. violations court this CEO be is is approved principle pay future enjoying similarly be and to securities in by as There I approved it neither Clovis penalty adjunction a

this And the further comment cannot we to we the I'll situation, with will on Dan approved. quarter that, second when it turn over settlement financial While to report on results. discuss is call

Dan Muehl

afternoon, and Patrick, Thanks, good everyone.

a compared and million, increase. XXXX financial included press $XX.X through XXXX patients release. for revenues a supply of in Most were for year-over-year. or Product of I'll review approximately $XX.X XXXX for results million overall assistance drug XXXX provided commercial additional million provide of the QX Part afternoon's in $X.X value patient revenue D quarterly plans. of Our totaled This and is this QX QX half XX% results XX% commentary. XX% our quarter. quarterly our to program This financial the second during the first quarter million represents supply of sequential are to $XX.X $XX.X of compares million some commercial these highlights free on quarter the in Medicare The XXXX. revenue increase

increase not treated of value, total and of percentage primarily patient from now prior previously Medicaid in our assistance with increase XX% as the our label. what With was XX% anticipated of program Rubraca, patient realized narrow percentage and which patients current the the revenue, in Medicare results population, treatment commercial from an around is approximately with

commercial free drug We expect the XXXX. the of to overall percentage for to high supply remainder of of mid- continue range XX% the in

approximately QX in million $XX the Pfizer new operations related million, payments anticipated cash for EU compared balance and $XXX.X QX approximately QX we to XX our was a to quarter the recent in manufacturing in we to of XXXX supply Drug for XXXX XXXX, used million includes million securities. million through and $XXX.X equivalents $XX.X of common XXXX Cash debt. We now with of offerings $XX cost in supply used million transition Cash will facility of total in $XXX U.S. XXXX. million and cash, operating milestone operational raised late remainder decrease activities April Turning convertible to XXXX drug our net XXXX. approvals. as to sheet. of stock to product product In and product of for be ended cost a first available-for-sale with

capital of in as incur late the million for facility XXXX well. We new will costs manufacturing X final approximately

new new needs do lower and substantially facility are progress the drug our qualification current we'll of supply. so We cost facility in than future at will pleased support drug be will a the XXXX. new anticipated This for of supply anticipate with the very Rubraca, and supply completed

XXXX. of our in We adding our we for by lead reduction costs and greater After and in approvals early for campaign will be would we indication. product reported million be gain the lower to net EU lower million, XXXX, XXXX. XXXX. and a maintenance share This $X.XX aggregate production drug for payments expect control XXXX. will is will be Milestone loss to to Also, supply in for per or also completed paid in will $X.XX for times production XXX.X limited pending compares per products. share XX China We approval QX API redundancy compared in XXXX current have of the in a XXX.X for location million or QX

adjusted Excluding loss to an legal we the per SEC for million losses, $X.XX XXXX. settlement certain or and per to share compared $X.XX QX share XX.X million XX.X for reported or XXXX related non-GAAP of QX expenses net

commercial progress. clinical compared Our for in million studies million totaled to general development will our will our in QX XXXX expenses SG&A expenses related support and XX.X States planned totaled compared expenses and continue million to continue to XX.X million and in of activities XXXX United QX also increase XX.X administrative Rubraca R&D QX to the activities to in Europe. increase XXXX. R&D as expenses XXXX. XX.X Selling, QX

adjustments double estimated approximately expected totaled recorded rebates, further estimated for of provide as Revenue mix I'll as low assuming in from XX% for consistent. gross perspective. discounts be or of a XXXX. color digits single the XXXX, some other Rubraca of well net adjustments deductions on to the high finance Gross revenue and QX Now to as revenue gross percentage remainder to the net net remain payer has distribution chargebacks, product and These are returns. the gross a of

quarter the commercial, other. pharmacy Cost distribution X.X XX% distributor. the approximately sales was of revenue. specialty payer for And for X% and quarter XX% Our mix XX% mix and million our and Medicaid product second or was specialty Medicare of approximately XX% was XX%

of We percentage increase for of expect slightly remainder cost XXXX. the sales to

the to Now back I'll turn Pat. call

Patrick Mahaffy

Clovis, to to for the provides enthusiastic activities to forward opportunity treatment in look second market patients. We're strong underway building ovarian We're at line cancer cycle would with our Dan. maintenance the maintenance meaningful of larger much progress here several of facility. Rubraca momentum commercial that remainder at all-comers continuing about population a Thanks, us the I year. the

pleased review in authorization And to EU plot, the from in treatment are maintenance months on for before review an the received second indication. are anticipate the treatment under six quarter XXXX. with of a a and Rubraca broad We have CHMP the the setting now setting opinion maintenance end

Our of robust you potential is approval. accelerated on patients, development underway mutations a October. particular to first at look cancer forward enrolling we well path And program the with ESMO prostate look BRCA to at initial showing data in focused in TRITONX

evening. a As accepted I'm discussion, event will Munich Clovis a pleased earlier, in as I followed on which abstract take the said poster that that Sunday to by XXst, place announce was afternoon, October investor/analyst and will be

to study in bladder that hope enrollment, opened is all-comers and patient Rubraca's for demonstrate we ATLAS population. Our activity

either or breast cancer, in underway, of non-BRCA are cancer. and in II prostate studies bladder including Rubraca our the planned studies Phase Opdivo, and with ovarian and studies advanced combination Bristol-Myers cancer and collaboration or our Clovis-sponsored Squibb through cancer studies, III Our clinical Phase ovarian

new combination program We of the With have. PD-X you look combination a to in or may are much about any development with next over happy discussing our that, with more very PD-LX clinical year. answer program be early year enthusiastic to lucitanib the and this forward a later for begin Rubraca, than questions I'll no to in and expected course

Operator

with from Kennen our Markets. MacKay RBC Capital first question And Instructions] [Operator

now line Your open. is

Kennen MacKay

to could increase is I you programs accelerated then the sort patients with And approval of the FDA the sort And the could for of pathway to sort that of when there? basis maybe way mentioned and an elaborate correctly, The you is by forming had other of a on quick RECIST-evaluable end on the be? that if to process, next number wondering for FDA the you the was the sort thinking you've about based little just bit approval some interactions gain were question of Pat, this with I'm seen terms are thinking so the have question that on? sort we've accelerated conversations really a of of TRITONX conversations about sNDA this of levels XXXX, in submitting data.

Patrick Mahaffy

Yes, for from had with in limited that's These the a the acknowledged we meeting to FDA. reasonable expectation FDA They're And the prior the notes conversations formal not initiation of were TRITONX. this. as for RECIST RECIST-eligible acceptable patients data from number are of we as that evaluation could a a TRITONX approval sufficient as an for accelerated of be long basis have the who response.

some they tumor response. have have an we've response We've this a but RECIST would as approval. particular, evaluate to would pleased So be PSA in to get TRITONX not been sufficient be as for evaluable PSA supportive, accelerated enrolled that of to described enrollment means, alone seen of percentage least patients, the And that are based at half. to the the hit BRCA are that on is we'll be in comments. we trial, the optimistic able BRCA, in we increasing who that mutant I patients, the deadline response see that written

Kennen MacKay

sort on one just other then question, of elaborating And that.

poorly question, 'XX to whether And something mutations non-BRCA sNDA or follow-up their such Or submit cancer. response BRCA then prostate therapies sort here? know on also to we chemo? as as BRCA? with either if potential patients Is more other sort this What androgens? better within patients you of of do about trial, mutations explore beyond sort of anything that mentioned with taxane do the a that in other back to for positive BRCA an HRD half could You've about patients

Patrick Mahaffy

Okay.

BRCA relates other genes, other mutations you focus population. deleterious of would HRD I to it as on the First,

related to We think, with, DNA enrolling other or are deficiency. are XX genes related it's be or repair that XX patients to could I

they expand vastly aren't in as how cancer, BRCA specifically here the what its be be And all about And patients then your for or NF best to opportunity secondly, patient in given that do BRCA prostate further early in to the only described can the with data great mutation, AR-directed achieved taxanes. the days on appears question trial on Munich. in in on population. BRCA-mutated BRCA, think do therapies to therapies, really I there unless seeing is other patients patients, we're we any required, be do

dialogue in a there is far, clinicians, thus of experience lot with are Our evidence.

and did did another AR-directed same. on we're that we were First, by told really told group then the therapies, they about they poorly

mutant know. they predictor be is that a X% various pretty available to must appear poor BRCA given X% of I'd patients are cancer the them for XX% range. percentage or the through that know XX% castrate-resistant mutant don't we diagnosis BRCA population, to patients, prostate get pretty say mutations of to progress time So in I prognostic treatments who are the do to rapidly the maybe those a because by BRCA. patients metastatic And you

really enrichment great I these BRCA-mutated empirically, say do a better there's on patients. that that suggests And don't therapies. So they well alternative would for or

Kennen MacKay

just to trial? your you. the FDA, of come does need is if see, Got ORR? the don't into I play with sort also a PFS from Or there, controlled Okay. we And wanted only conversations survival guess, focus on or even

Patrick Mahaffy

response, of buckets: studies. kind into The an on not accelerated taking response surrogate a arm rate, in of duration X limited single profile general, to requirement single-arm the a as approval the in accepted survival risk, for is primary safety meaning and drug. account Progression-free benefit of study, are

don't believe duration of I matter that will. to So survival going progression-free is here, response

Operator

question Lawson next our Peter SunTrust with comes Humphrey. Robinson And from

Peter Lawson

about you are thinking of How the TRITONX. on prostate patients? Just

Peter Lawson

on you as are the patients? you about prostate thinking of How Just What TRITONX. success? view do

Patrick Mahaffy

you, you thought our about kind at opinion, by or And I'll I'll tell about give how independently was ASCO. that bit have an advisory and my We opinion Yes. a little confirmed we of then I'll lot. talk this board a

therapies a having approval, response been two, approved a was number a that started safety for heroic. we've it's view these would a it of most the to realistic started if are chance their good. through think think with see response with taxane-based And have own think we used a given third there three, would which very a then, you as these that my four, very was duration men if on I with profile a that is is taxane-based therapy, think XX% something is that our said, remind if very, what I is a been have expected started far, their I've have be rate with well-tolerated as chemotherapy, getting consistent I number If that seen no an recent the with which I around odd's So rucaparib if men drug. the XX%, particularly, chemo. I'll and that rate population good, the so I would

difference to disease. a through said ASCO, would be mean, advisers, for PSA men the been these had we interesting would what's reflects we the And than they lot standard required incredible. therapies think our they but delightful, more to and kind clinical stage in heroic, board "What prostate note would When at ask be of for to question, I ad a response response. the an thing of be great?' that that, I mean, advisers regulatory practice. a at it's cancer between used what's achieve their said prostate the the of And given have XX% asked PSA I number

for the for they're of But response scanned the us approval. may development, part, stage made been FDA of requires look a progression. by to the kind to a success clear in of PSA growth of have to that possibility symptoms, These RECIST bone. looking or basis as accelerated We growth, time symptomatic have clinical be a men bone for response at tumor most at this release and they're the an

Peter Lawson

couple just a then And I for questions, guess, Dan. of

we kind be step the that And around Just number that's program, stocking if today? why about order up should any that patient assistance happened? in of in thinking there's

Patrick Mahaffy

patients a increased, Medicare take crack the correct? to asking. that's is, going why if kind at of I'm what of percentage That you're

Peter Lawson

Yes.

Patrick Mahaffy

the or mutations population we to XXs, tragically, in the to XXs, ovarian demographics BRCA cancer these or limited on I BRCA going their with were with diagnosed XXs When for many are before be the treatment new the think reflects eligible in label. indication, women mutant they're of it well Medicare.

a going a because eligible XX% women have now that over women we proportion Medicare has they're are of expanded of who who we do label are BRCA to to see higher the not just As mutations, have XX.

Dan Muehl

And Peter, did you say, ask about stocking related to that?

Peter Lawson

kind Yes. inventory thinking Is should of be stocking? we onetime anything there about that

Dan Muehl

No.

we've As in quite spent drug you've year. supply first on half the the bit seen, of a

separate look from that's of our if at the programs, revenue. So fulfillment patient assistance you the

patient have to vendor product that the actually assistance we program. of that supplies a So all

caught not it's our up normal So channel. in distribution

separately. stocking a no within at our from that point view, situation per total supply [indiscernible] And it's this se drug there's So consequential not point. revenue really of

Operator

And our next question comes from Tazeen Ahmad with Bank of America.

line now is Your open.

Tazeen Ahmad

statement to something Pat, discussion prepared follow at up with abstract you ESMO. on accepted just said for poster your about having wanted your

the present that work? process an little there why Just does to as for a better, bit be oral? And so Is also selection understand that that option I guys? opportunity how an wouldn't you

Patrick Mahaffy

than great ESMO. trial time we'll smaller the abstract for presentation. those poster presented like sufficient can say for be there's being for have stand And itself. between for going amount the oral opportunity ultimately prepared presentation. may what may a the the the data data think give an oral think, remarks, of will oral a I And those presentation, also been in get going it's we the by amount NF great had I And frankly, have dialogue a think would abstract in attention meeting, Street. sets was if just clinical here presentation. date for given was it date if have cutoff the I will liked and but too submissions small will discussion is and that by no as and I as or line committee, the be it. amount a outside that presentations, accepted patients poster report in to the I relatively amount presentation. will of Well, at this presented about the was The the doubt there the the in cutoff an and no is it noted attention. submitted oral of actually arena is same to both and an think an difference don't get say I the effort be I that oral around happened the it little presentation, of on, to patients it will There's NF and that been exactly Wall there it an to And in are that feel same. to there I get I just,

preferred would totally presentation. have abstract. Munich. So we given We the forward presentation the patients not to yes, surprised the do oral an NF in look in get I didn't it, I'm

Tazeen Ahmad

part because it next you do Or realistically, line year, remain the the your steps and 'XX expect be end? for more sNDA of and plan yourself end certain then likely take of the And then wide you're being long? that giving file on the filed that to earlier a towards is will by time not towards here,

Patrick Mahaffy

to X, cetera I could of bring course, have have so timelines. to want XXXX, the there we somewhat, If think that. enrollment, that fact patient patient But timeline, a that were I'm obviously, prepare enrollment forward and me. cause et comfortable to we that time NDA. do that us August to And we enrolled. as feels with of It's every for enough driven any the the would submit realistic of events, a timeline to guidance those then given. And then we've minimum response, two that's by patients scans deliver

Tazeen Ahmad

one quick commercial. maybe then question And on

one used about of you Zejula to have share prescribers of previously is can they're third PARPs, those the other users but LYNPARZA those or doctors for whether Rubraca? talked PARPs time force first already, primarily the us users? choosing from sales from feedback that reason on And any You scripts prescribe physicians with are main were what

Patrick Mahaffy

these that clarify breakdown. I for either them had they prescribed the had already of to PARP third Rubraca. any I'll Rubraca. were About Zejula, But first first time for are exact prescribers and Many all Yes. of first want don't or prescribers prescribers were answer then we LYNPARZA question. of QX in I prescribers something, one inhibitors, not have those time new

a for has is and things are those well the is hands patients that Rubraca, it. who in performed community in and experience clinical used with eyes it think who their a drug One in have of happening. couple I have the

we we're we were prior that now, surprised Rubraca. because those our of of enthusiastic you're us in about in one who but So maintenance using many the adopted LYNPARZA we're indication going for using physicians when that, told, And now the were or were to Zejula not by approved, approval, use are expanded approved, they it. to narrower indication,

itself think marketplace. So that's I manifesting in the

But are, that particular, good going this exploration to not ARIELX experience those describe physicians had a with to believe some effort standard the legal Rubraca, be think I For tribute now LYNPARZA, in and field. good data had is is sales There hope that experience LYNPARZA, care. I I'll pretty team is from and the with the don't believe should have just physicians new. going MSL a to they going new. [indiscernible] are say, who data I that may to keep with the LYNPARZA. there doubt, get I to Rubraca the persuasive reps explore and the just And using in these them of why these about and receptive "We've try given and that or they ARIELX beyond of to maintenance something And trying it." think indication pretty of that our are committing no quality results now either to something delivered, data on Zejula one the the need by understand that are to

Operator

you. Thank

Barclays. comes Our next from with question Gena Wang

now is line open. Your

Gena Wang

on revenue part. just question follow one would the I

quarter the last revenue, of $X quarter of mainly the maintenance growth wondering, by this is For patients? the million over driven just is

Patrick Mahaffy

Yes, it by is driven patients. mainly the maintenance

Gena Wang

then these for And for patients... maintenance

Patrick Mahaffy

maintenance more actually the driven it's maintenance kind substantially driven say than patients. You the patients, of can it's by mainly by

Gena Wang

patients, then what can inhibitors. you actually new share if and PARP I for And are with switched to percentage percentage inhibitors don't the patients of these us PARP know maintenance from other the what

Patrick Mahaffy

at have experience to prescribers and LYNPARZA I a number get majority think have Zejula. have hand. many As of LYNPARZA our with that of that don't had Zejula. just prescribers experience the don't either had new them I but new of noted, I'll We'll about to already I X/X were prescribers Rubraca, at try say I hand, or number, our but with

Gena Wang

TRITONX What I not mentioned RECIST also only have, PSA what about would you you of And will your Pat, think trial. another actual response? RECIST then but order, And question of be then a impressive. would the be you to at have response? response also that response regarding in response, the a rate on XX%, know you duration look kind that hit supportive is the just for thoughts

Patrick Mahaffy

Yes.

would duration of think, line these response, or of that would the sufficient, hurdle. we If I late men. over line X for later think given be a terms for be months patients, these hurdle, In this X that represents I get

X opinion. or opinion think think would months right. seems an in front I an sufficient. of informed about But I and that duration FDA. Hopefully, So X other by be by drugs Again, that's FDA approved

If pretty XX% the XX%, in it up; starts And encouraging. of, it percentage about the XX%, I numbers with a really that for response: the supportive, about advisory PSA PSA was was PSA response. XX%, heard valid or investigators They're the equally question meaning sort response. XX%, second given board. encouraging. Your are PSA would X, the fact, response of I we gave say similar the from

part on FDA So other numbers enthusiasm and generating community. in one similar terms from I'd of say part clinical the from the

Gena Wang

just then patients. last of one number regarding the your And question, Okay.

many go patient to think do be to data approval? how to So FDA ask will compelling it for you enough accelerated

Patrick Mahaffy

in patients on response a cervical rate. approved X-X, percent recently cancer again FDA XX, XX KEYTRUDA at

you I think to are, shown willingness has better off the So consider I but lower the FDA healthy think XXX, their get to you a number.

that We TRITONX imagine I over informed dialogue would And have not from yet quarters. had of take by would a with couple data next place FDA. the

Operator

Gabelli. with Our next question comes from He Jing

Jing He

with to versus how TRITONX and compare you Study just about strategy. model, in of if Pat, ZYTIGA think their design is So X tested data wondering which combo the and combo I'm olaparib, X

Patrick Mahaffy

intrigued the strategy. by We're combo

is referencing presented was abiraterone olaparib-abiraterone that correct. study at ASCO, versus the alone think I you're

survival, trend XX it's some data. are into like was subgroups, number, allows XX X benefit months intriguing good you overinterpret XX patients you patients versus got on the most is you exciting, non-BRCA certainly of end overall the patient, got It scary And as but When to not XX wild-type statistically your may XX, there at significant. a X.X, recall, something it. about about XXX particularly kind either about anywhere obviously and that small. was with that. at pretty the patients, looked and months arm. So level progression-free ones versus

overinterpret So hard it. to it's

the safety. I struck is think us what

that's, the cardiovascular and reflective XX% rate, real therapy. around men number. experience whatever the abiraterone combination ahead on You is prostate the of has arm just the earlier worrying XX% the one them. And had cancer to therapeutic XX XX% this a these line the oncology, the out it high with It on of on patients' events, imbalance both. would really combination combination, expect physicians' expect a notable and with withdrew on so also That's including multiple experience dropout patient, the than, of options X combination be was see we time alone. patient versus to either and Particularly patients therefore, of a of serious to withdrawals. that deaths, of is, have was from

abiraterone one am off right of in is So along in I these doing cancer. all-comers lines. now. in combination, We're colleagues we're combination you supremely enrolling while with I'll I dialogue prostate we're one combination validated been think, I don't right don't in interested has remind investigators, yet. that now that our an population Bristol, the Opdivo with think of

lot that questions I of in data think a set. there's

Jing He

XX%? it helpful. stabilize level? you to or see the I'm wondering And Like, expect to also would free drug what And when expect you ceiling? very for a That's just use, at

Patrick Mahaffy

mean, right put on XX% be a this. We on reason, not it's pretty know best now, the ceiling. it's And a what restrictions are light ceiling, it we as, doing think within some I should from our close. feels, to, if I picture

so And there. we're getting hopefully,

Jing He

what lastly, could they wondering feedback, have And I'm PARP? color consider treated like, patients on some a retreatment? on physician by would retreatment. you at And percentage previously of just provide point what

Patrick Mahaffy

Yes.

prior to still So right or had, third had our a rucaparib, had a have around PARP at We're of I now, was, prior now patients, that prior, XX%. think, of as one XX% inhibitor, our chart patients the our percentage peak had do think the become still line inhibitor. that about that third majority of recent a have PARP most on patients it patients claim I maintenance. one made shows number of second

had the indication. third approved that maintenance was that perhaps by we think had treatment drugs we two fact line and I the influenced

that little bit. bit, change maybe suspect will down a I So little a go

to one the ad boards where I everybody But a overall was community consider PARP about willingness we their so the very pretty ovarian of took at ad this one mentioned is at call, boards, live it our of retreatment clinicians high. ASCO. redundant. the will survey this of XX these clinical the inhibitor on think on be with I'm vote I phone. And cancer of could sure

one time. influencing was do So clinicians as because limitation, tolerability everybody it it person of the there, one had as that would progression. voting one because would they a up PARP said, And that real gone of said it, of wasn't the had XX inhibitor. retreat And a the patient they issues, was long only limitation without with XX not

pretty retreatment say patterns evidence this, would the the from I to of suggest willingness and usage So that unscientific admittedly, own the our that both survey, community consider is high.

Operator

Kasimov question next Cory with JPMorgan. comes from Our

Your line is now open.

Cory Kasimov

view. commercial a from first I two one point for of Pat, have I guess, you.

currently I believe And in about maintenance prepared the treated. PARP currently talk that talked comments market how awareness has You just dynamics you Can one aren't imagine lack you another then class of why one the then was about and this at about they third of the level? of PARP your third sits and the third, at only one its Avastin point. can't share class another

that than there something find would have expected? biomarker there? are you docs more else ordering test on Or you is So going

Patrick Mahaffy

are PARP the up about BRCA And inhibitor. patients. higher that when BRCA It's to the getting it I XX% something of not who clear, make like down XX% non-BRCA, it's to probably Yes. you are getting Interestingly it And a in whatever would BRCA said a by enough, XX% to PARP XX%, that, who XX% XX%, are to patients, who of percentage quibble and maintenance Corey, inhibitor to be that non-BRCA. difference, getting a setting. break is are

it to forcefully the I may word or that surprised think of trials And treatment that setting, this were yet. a trials The think gain the those programs. experiencing approval, primarily know And academic second would hasn't little you those And the amount get inhibitor a that infringe podium speakers are which Avastin, who in out is are with for with setting. used during do, in we've PARP are despite go go months other going changed that prescribe, through to I a And platinum who probed likely hard who publications, through to I we're pretty more would community likely XXXX, practice. is to treated the it's academic been you be activities, think we you something Avastin in add two was way what initially, centers maintain Avastin who of in other participants to share, have just either that patients Avastin at is the afterwards. that, the this, kind doublet, more to PARP clinical is but with And of you expect and much. prescribing common inhibitors, companies those it a marketing dynamic. already into but be through drug centers, three practice

the frankly, here. think the One trial. Avastin, two maybe trial, And period about We apart for if look that with versus three on choices And the in maintenance arm own seen sort months benefit is than of months. we've better consider have you is four to I our growing at Avastin. non-Avastin

a the have tox. add Avastin inhibitor. on is And to That clinicians, in setting. keep as Avastin consider, direction thing other a we to but hear they that many maybe combine drugs consider because synergistic patient from don't a PARP The the they'll well,

competitor desire hopefully giving lot of getting patient the go to talking a breaks and disease." to could is, we allow new requires here, make that why the they but of about growth our have break. manageable going direction or is pretty will For desire progression-free tumor more at for physician be tumor these to extend meaningfully we you ovarian Rubraca, the it to consistently to need to it. and progress with a But if to reagents, have which have tolerability, cancer it making may are weapons It think there's real a been a says, is have period make community more These growth, you this manage intervene. making now to a drug-free driving you're have multiple could this that manageable, a chronically more reasons can not, colleagues therapy, platinum going chronically those who are "Look, of things it not be A I as message think we're about too interval. chronically least manageable. survival, we Meaning, chemo

we our broader lot So a know got considering our to to competitors colleague and prescribers. this It's evident have are community messaging. about we that get of and

women, created from We patients, elderly in otherwise only experience considering not the take own getting group And whatever PARP from is, use have approach ARIELX the One encompassing other who that goals two prescribers inhibitors, would younger with or that drug, for their that BRCA maintenance use irrespective benefit it to any I the had says of wear begin age, limitation. data, those and have that. our wash in who patients, to PARP is consider to algorithm then all-comers of case, to. secondly to or the says, really in they patients, is skeptics, a get in

to we I've what the described I programs clearly to place So putting you do what and written put described. in are in reacting text are exactly have and to

Cory Kasimov

question primary going to analysis and and to to data Did ESMO year? And how you say it BRCA kind at confirm going something of my only second the present is Is is patients? you're for next wanted TRITONX. that the I submit on be go back

Patrick Mahaffy

patients with, a We'll patients; of XX patients; which It's ATM repair each of Cohort C, DNA is which deficiency. Cohort the for B, group report genes is cohorts more number, at by other is associated a largest which far, forgot A, and BRCA than little that. ASCO. But is Cory, There's the Cohort I the XX the BRCA-mutant No. with or data population. cohort nuance

believe seeing in that So approval population. in by the I interpretable. for BRCA-mutated FDA given second, dialogue, an given patient it and I is our accelerated we're is what opportunity the far think the sets, And data most say, would best

Cory Kasimov

the That's by out BRCA-mutant break for rate will segmented, response it you the patients?

Patrick Mahaffy

We will.

Cory Kasimov

what have And mutation? then you us patients prostate remind just can of cancer percent the BRCA

Patrick Mahaffy

publications varying this. There's on

the as mean, somatic, include I you as and range XX%. low XX% probably, it's is as and If germline as high

XX%. So XX% to

Operator

you. Thank

question Flynn Terence next Our from Sachs. Goldman comes with

open. now is line Your

Terence Flynn

Maybe follow-up. just a

I and the here the PARP it, as that the the growth about mentioned contingent other you further inputs You those us duration I potential just share, guess is treatment we also U.S., in revenue maybe on about think guess, base. market about growing prescriber this. so generation, about think think as think help we into

think other If the about you're a longer going taking how the be base, do growing X drivers we prescriber time potentially? to

Patrick Mahaffy

months we So recently or treatment the and enrolled we a most little treatment growing the we X.X average on when at more indication, in we, duration when tumor. This, of bit with who X.X women setting. duration looked data mature had course, were is at

setting. So the of expectation the drug maintenance than higher the for immediately is

XX% average the BRCA based get on benefit. you any to the In trial, We X.X duration Normally, XX%. maintenance to most patients, where duration to On limited Rubraca. on launch. it's have significant data was that would months the don't expect other discount the hand, by the the you X to

get we that the on the hope in experience have So X.X-month to duration the X- in would based ARIELX. of all-comers to I range median would we population

share, take obviously, terms we're think market share. to In beginning we of

what too in early describe pricing. I it's us think we have a share for to little

therapy, on I been there's a it's zero-sum you prescribers patients the prescribers share think population. move who are share and grow the in I I beyond some begun we to obviously, some focus people dedicated think us But both and think those that get to much gaining, and to the committed have and of maintenance noise eligible saying person I this to just, therapy. just little for me, people to share, We, game this the of are this and want all have treat, who number too share, It's another to this number prescribers and share. have maintenance guys.

pretty to I'll So optimistic the we're to through Terence. there, a get some I just clients is think to got tell that infringed going committed story we're mean, tell, and have the one. say both. powerful that We I'm to frankly, practice. But get had we to I

Terence Flynn

Okay, that's helpful.

And how at kind do three Street think you if estimates guess to I these for variables the the XXXX, mean, estimates? I XXXX so of relative about look you

Patrick Mahaffy

We little so it's guidance, estimates reflect ready guidance. given hard have on to giving a We without not effectively to don't those for guidance. feel me give

at the of in our at as And we'll we will comfortable give said sales next as feel We to plan do a before, January we I've guidance year. that JPMorgan growth. dynamics understand so minimum,

Terence Flynn

thus Anything just on seen maybe what on ovarian tolerability in And one or to TRITONX. the relative last you've far? safety different Okay.

Patrick Mahaffy

this No, maybe line [indiscernible] a is it the incidence is in anything, see true fewer small little is a that had not to will And that of all. If abstract, in and have the ovarian we'll bit that women difficult in, myelosuppression lower. it these later men regimens still but compared cancer. the

tolerate setting. that little than it ovarian may bit the entirely not they surprising it's a better in So

Operator

our question And with next comes from Breazzano Evercore ISI. Steven

Steven Breazzano

But ask impact asked. can SOLO-X been have second mine of I the the line on indication of just Most potential forward? about going

Patrick Mahaffy

Yes. We the is which it's SOLO-X I ESMO, at going look great. be to to data. seeing understand forward

of a had view, germline not to lot dialogue we of what if get by be front probably lucky, not a confirmed say, germline/somatic, and formal I've can own get with get for she germline news go will good ultimately BRCA, she and that on maintenance be and our to consistent second suspect research, but market as impact, in in does going the chronically retreating news, So It again, dialogue on a will PARP more woman lot but attitude it's about again should opinion. going to limited I earlier impact have before, think but PARP to only ovarian the ESMO a have instance, go did her meaningful she'll her they I certainly all-comers a I to don't that's, prescriber don't not not a mean used how it's treatment this that well cancer can path, consider So taken, BRCA be into analogous that's follow for the but SOLO-X it's for as opinion XX just not disease some FDA BRCA. meaningful to path in believe hopefully, have Phase to and who give I of have turn and with doesn't said PARP have formal their the is patients, My pocket And inhibitor you all-comers? maintenance manageable my inhibitor. don't II disease. it olaparib there is but going platinum, to they going does first they're the to phrase so as is Study know regimen, and people short-term. going with maintenance frontline clinicians. regimen. throw more population on I if the It of back it, I will We in population, is, all-comers, maybe germline about an But going an gets, fail, in they're inhibitors. in

of is process. to part that PARP retreatment a think with I so be going And inhibitor a

Operator

questions I'm further And back this to would not any the remarks. to turn now Sussman time. like for showing over Anna I further any at call

Anna Sussman

Daniel. Oncology your We interest for Clovis Thanks, thank today. everyone in Great.

XX follow-up of an it about be beginning available a XXX-XXXX. call reach any have days. a good at appreciate webcast via and (XXX) me interest can This time. XXX-XXXX you, (XXX) at And at you our replay Breanna your our have and questions, in and evening. could and we website, accessed thank you If will Again, for be hour

Operator

for and Everyone, you participating wonderful you may thank conclude have does a in today's gentlemen, and today's conference. This disconnect. Ladies program, all day.

Clovis Oncology (CLVSQ) 3 Aug 182018 Q2 Earnings call transcript