CLVS - Earnings call transcript Q3 2019

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Clovis Oncology Third Quarter 2019 Earnings Conference Call. At this time, all participants’ lines are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]

I would now like to hand the conference over to Ms. Investor President, Vice Burkart, Relations. Breanna Please go ahead.

Breanna Burkart

Simon. Oncology third you, joining Good Thank morning, Clovis the us. to welcome quarter for and you Thank XXXX call. conference

is news likely If this have our morning's You not, at seen it available www.clovisoncology.com. on website release.

this be reminder, being is archive several the available be on call Remarks during the weeks. recorded our next live our on conference website webcast. call may a As and accessed and will for

discuss our Today's greater call Muehl, components Chief the will agenda will also will the in financial remarks, the and includes corporate for closing Q&A, questions. Clovis' few be available Dan during quarter's results Officer, Medical Officer, to key Mahaffy, highlights then, Dr. President today's Patrick make Financial of Patrick cover our and the detail. answer CEO, which a following: Rolfe, update; open and then we'll time, Chief will Lindsey

begin, statements our we and during please statements concerning business today's financial Before meaning that securities including call, federal plans. the the within expected conference note laws, we forward-looking outlook make may of

are these uncertainties in differ forward-looking All described that from statements actual results of risks to to could materially statements. the those subject cause and

the SEC the Please refer our our a current filings and full review to of uncertainties for with risks business. with associated

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

Patrick over call Now the to Mahaffy. I'd to like turn

Patrick Mahaffy

Welcome, Breanna. Thanks, We taking appreciate everybody. you time.

the duration and over new for growth global revenue for by starts $XX.X progress I'll This XX% million, was use. Rubraca. was pleased our last and XX% patient encouraging the that this begin I'm quarter with in in XXXX. driven commercial of over to QX update quarter report up

continued to drugs. supply in also free the make We of reducing progress slow

same: as early EU through cancer U.S. adoption grow advanced the England, indication the addition BRCA to launches ovarian treatment Italy, cancer near-term increase France beyond increasing the revenue share by market us the of along remain cancer objectives revenues with growth in of setting; in that the the recurrent in U.S. To mutant ovarian potential and and grow Spain setting. revenues advanced near-term maintenance key through Our program indication in And the development mid-XXXX, our most revenue in with to as prostate Germany; in new prostate cancer. brings and ovarian continued

in we two TRITON have know, the focus program we studies and on I’ll regulatory path studies. ESMO you the forward. the presented TRITONX, data As patients TRITONX and in the ongoing continue moving to and both enroll at

castration-resistant showed assessment investigator objective by trial, in resourced presented at In TRITONX data XX.X% primary review, ESMO were updated TRITONX evaluable in prostate the consistent The and with September, endpoint of RECIST XX we with BRCAX/X a the data mutations, patients patients XXXX response radiological rate which updated confirmed presented, in metastatic is cancer independent Congress at Barcelona. by the XX.X%.

antigen were Confirmed In PSA weeks PSA XX% or with durable, confirmed XX XX% in mutation. with lasting was longer. observed rate a BRCAX/X addition, a patients radiographic response prostate-specific response-evaluable responses XX or

consistent data were in indication data at those The ESMO will at patients also include Rubraca NDA our supplemental will reports the cancer reported presented TRITONX patients, ESMO. patients for will planned supplemental additional although in confirmed on in solid response. for prostate maturity NDA set this in be from with other filing filing based and additional men TRITONX in data BRCAX/X-mutant advanced ovarian be the These RECIST in Rubraca cancer, for and and data tumors. observed safety included Preliminary prior with

this to for Following by year. prostate submission BRCAX/X-mutated our end treatment file continue for the advanced the in successful cancer we supplemental approval NDA pre accelerated with for NDA with October, FDA as of plan Rubraca meeting men supplemental to

basket with first registration study mutation or end in next Our to patients discussed this the tumors Rubraca initiate It you genes. for other earlier with support year. study the will anticipate early solid or planned monotherapy year that XXXX deleterious by year. designed perhaps across therapy homologous we in pan-tumor is that is We repair study recombination

our with Next, with I'll a then Rubraca I'd our like BMS combination Squibb, with both our enthusiastic to and and compound, briefly combination We for both discuss ongoing lucitanib, clinical remain collaboration very studies review to moment nivolumab. highlight Bristol-Myers and take Rubraca studies for lucitanib newest our FAP-XXXX. and about

enrollment the combinations. early the and with I'll will with combination cancer that midyear XXXX. FRACTION maintenance BMS-sponsored Phase study an the of advanced is study be gastric of initiation explores ovarian enroll. gastric moving X,XXX-patient new first BMS-sponsored continues Rubraca Clovis-sponsored Yervoy trial in cancer castrate-resistant The sponsored XKD in cancer X well, The Rubraca as enroll the anticipate in triplet first-line by of ATHENA advanced XXXX CHECKMATE we Phase study. prostate The X this advanced X study combination. begin metastatic Opdivo for of this planned continues trial completing forward This Phase with to in and to treatment arm cancer

we uniquely of outcomes. [ph] evaluate we believe to key ATHENA, positioned are two With terms Rubraca in

is in plus as placebo both, and PARP maintenance advantage for of first switch monotherapy well combination one of combination Rebecca the as same versus the inclusive in designed setting, maintenance in first-line the ATHENA PD-X BRCA, in PARP therapy population. front-line the As design. to or the intent-to-treat the study any patient monotherapy study and all-comers population, HRD Opdivo population, potential show

that helpful be statistical understands plan It may make to everyone here. the sure analysis

we in in monotherapy analyses, step inclusive study the results year First, entire Rubraca the we intent-to-treat In probably of down Rubraca population. will the or versus in more evaluate half results of second in then populations. the will the then, versus these Opdivo will of population. we see first later, a outcomes XXXX, plus placebo to of And our all study see each Rubraca and population, BRCA HRD of

also rucaparib of lucitanib, currently Phase which following to for dose Xb portion lucitanib govitecan in includes cancer which metastatic is Rubraca tumors. enrolling of to with turn includes study in let's and SEASTAR, combination Phase our move ovarian triple-negative multiple studies, of Xb/X portion Phase the metastatic is platinum-resistant in on Rubraca combination patients Xb the and with cohorts: currently breast the Immunomedics’ advanced dose-finding To wrap cancer, urothelial enrolling combination Clovis-sponsored study up Rubraca ovarian currently sacituzumab single-arm the solid and with cancers, cancer, treatment relapsed finding study, which the in that

and an factor tyrosine investigational to receptors Now X through and fibroblast endothelial factor Lucitanib vascular platelet-derived alpha is receptors X, of kinases including receptors growth inhibitor growth beta, growth factor X. through X lucitanib.

prior encouraging the in of drug these inhibits PD-X in types. lucitanib, of to development very in This the of multiple data on combination discussed we same We are three lucitanib with combined tumor there studies provides when similar As compelling the calls, a the the inhibitor. large with which combination for potential PD-X. the solid PD-X with market a believe represents rationale clinical antibody, opportunity targeting lucitanib monoclonal pathways

driven to proliferation targets of the and Angiogenesis lucitanib, has responses. antitumor within PDGF immune angiogenesis that be tumor simultaneously FGF proangiogenic shown cell antitumor and Preclinical the the enhanced PD-X receptors. well demonstrate microenvironment, which as dampening by been resistance pathways three by as activity through relevant inhibition data tumor receptor inhibitor the therapy immunosuppressive anti-VEGF targeting is of

Squibb Earlier Opdivo expansion with planned this the Bristol-Myers announced year, lucitanib. to collaboration include of of combinations we our clinical with

medical is enrolling tumors. of beginning study preliminary with from other in and meetings Xb/X with We Phase Clovis-sponsored of study lucitanib at in hope combination now patients data gynecological SEASTAR that Opdivo study this the rucaparib-lucitanib the part to Our combination solid have mid-XXXX. and is

of BMS In evaluate spread addition, cell with that a reoccurred Opdivo, will by posted by chemotherapy Phase has including multiple the week, sponsored the immunotherapy. lucitanib combinations failure with as or of an after in ClinicalTrials.gov with arm in combination patients lung start year. to and is on This study expected combination study X non-small cancer this stage X/X end

global lucitanib, and jurisdiction. As term up in excluding China. years we Europe in XXXX intellectual property, in extensions in XXXX five rights a available And to terms of of matter patent lucitanib’s in each to in U.S. expires have composition with the reminder,

visit of on website. and lucitanib, updated presentation events For an the overview please our page

Now, expressed licensing cancer imaging announced it XB in In briefly associated focus and FAP. majority the which radionuclide pipeline, with fibroblast FAP of expressed or suitable a to epithelial wide initial than peptide-targeted highly an to the XX% I'd Clovis we breast, alpha fibroblast activation many newest including are array highly is colorectal global cancers making agreement agent a Pharmaceuticals a addition targeting in found in tumors. potentially carcinomas. is lung, therapy and pancreatic like collaboration and CAS, FAP-XXXX, cancer the It across types, of describe solid and more or target on the of FAP-XXXX. September, protein

obtained U.S. has retains Clovis clinical excluding will where global global and XBP rights. Europe trials conduct and rights

also FAP-XXXX to a are file the for to of We in second XBP at which for We half planning have directed we for collaborate XXXX. radionuclide discovery have agreed targets program three additional currently rights. global therapies on IND an and

focus which of drawn are We least class this the We pharmaceutical opportunity field enthusiastic radiotherapy. be of an novel is to opportunities the therapies to to targeted reasons, develop our FAP-XXXX. radio emerging many leader the this not on with very program about of initial were a in for targeted

types. there unmet we of the needs immuno-oncology, also this companies. enthusiastic to about case, discovery clinically and extremely as medical is the significant we're pharmaceutical a tumor crowded enthusiastic in develop larger everybody of with field are have potential opportunity the to our targets the planned about it While In radionuclide by first the collaboration. be is we FAP-targeted subjects clearly, multiple as dominated And remain

intend Rubraca, Finally, with as agent, biological and clinically there an while potentially explore combine rationale therapy an well. our we to with on these targeted is focus as well to and as is anti-PD-X pre-clinically initial development evident combinations monotherapy, radionuclide

that important PSMA imaging with treatment of increased any under is to initiation and patient which note with of responsible is begun to Lu-PSMA-XXX, development image patients the PSMA-targeted here trial, particular hundreds not It the you was patients Germany, familiar Already, in history other has for one these may the countries use were centers Now, of in named to used or patient any that prior clinical treating products. radionuclide, German program. some used decision. solely the under certain to is targeted of that physician [ph] in applied this clinical the be of formal FAP-XXXX same and guidelines named

As a experience needs. possible medical guideline describe appropriate. presentations clinical is patient administer as will of this such we date physicians who keep that result up any may FAP-XXXX to under of And named use on it their the upcoming use, you

with And over quarter results. to turn Dan third financial the XXXX that, call discuss I'll the

Dan Muehl

morning, Pat, everyone. Thanks, good and

$XX.X $X.X of revenue financial of net XXXX, of revenue revenue net product for which for ex-U.S. XXXX and all XXXX net a a are XX% million We reported of U.S. Rubraca QX release. QX over today's and QX XXXX for press million results increase net $XX.X product The included U.S. included in to $XX.X product represents revenue the million, year-over-year. XX% QX increase This compared million. product

increased program XXXX compared to U.S. revenue drug for QX revenue supply and commercial eligible lower XXXX net XXXX compared million XX% for year-over-year. value assistance QX patient was QX XX% to of at The XXXX represented from XXXX. in to increased QX million the $X.X overall product of distributed to XXXX. supply in in QX free $X Ex-U.S. from Rubraca QX commercial This patients XX% QX anticipated. XX% sequentially sequentially through XXXX as

provided XX.X%, from $XXX adjustments respectively. XXXX XXXX for and million during net $XXX XX.X% net reflect full product quarter the to global QX to million guidance fourth of revenue range in were we of that update Gross the to XXXX. flat Last the guidance quarter, the $XXX potential range QX to XXXX to we to million for for Today, of growth year. continued $XXX million at a

Turning cash. discussion now to a of

raised due for general in September total convertible In had with As placement from and $XXX.X in in we proceeds $XX.X proceeds net $XXX notes XXXX. convertible remaining million of were of XXXX, equivalents, of notes A million corporate million repurchase due million sale purposes. par $XXX.X securities. we cash, $XXX million value used available-for-sale the to of of cash those a in million private XXth, $XXX.X available of August,

financing addition, XXXX. through we to XXth, In clinical still TPG trial of financing million QX the agreement remaining ATHENA for the as the ATHENA September expenses upto had fund $XXX to of trial under draw

available-for-sale their cash principal Based that cash, cash, $XX anticipated available available-for-sale maturity second in we notes half million fund sources equivalents our revenues, This we the unless not include and equivalents and on XXXX. into amount to plan cash the remaining of have securities, pay required does Company's we any believe refinance existing may the convertible repayment September spending, sufficient of at off, be XXXX. and to financing cash securities operating

used for compared XXXX lower that first for XXXX million worth months and operating and QX XXXX. of operating on than nine of used a QX $XX.X the Cash cash million $XXX.X QX XXXX. activities was $XXX.X nine $XX basis, first QX million It’s million XXXX, the to in months for XX% mentioning was sequential

We In reported to share $X.XX nine resulting for provided or cash QX net in for a million a decreases loss $XX.X months TPG the in net of and QX, operations, $XX.X net addition these ATHENA million of a in in or of cash XXXX. loss financing per per $XXX.X of $XX.X used cash quarter. million, the XXXX share $X.XX the in million during reduction first

loss the share $XXX.X $X.XX or nine of months $X.XX for million million net Net expense $XX.X compensation million the of share first XXXX million million per first for nine loss the periods for $XX.X loss $XX.X of a $XX.X compared XXXX XXXX. of comparable XXXX. QX months to per and or QX share-based included was for $XX and and in Net million of

first million totaled higher primarily the for for and QX XXXX. The and million and $XX.X to million of to the XXXX, $XX.X and $XXX.X is compared increase XXXX months for for in costs research trials. nine Research expenses million development periods development rucaparib clinical due comparable $XXX.X

trials development compared and our the programs starting near related and costs XXXX as lower and clinical other as year reduces full clinical largest and research XXXX, completion trend expect We the spending of to the for following activities. sponsored the Company in years, to to in

to XXXX, million XXXX. million and to for Selling, also the the Company. million million and sequentially in totaled QX $XX.X expenses $XX decreased million of in in general year-over-year compared $XX.X based comparable by $XXX.X reduction XX%, the Selling, and from XXXX $XXX.X and XXXX administrative XXXX on QX cost and XXXX administrative for QX periods nine $XX.X expenses general for for by million QX first months efforts

Now, it Pat. to I back turn

Patrick Mahaffy

Dan. Thanks,

quarter. space, sales England, setting, pleased We’re third growing remained the the in Germany expanding Rubraca, performance and bring maintenance focused We well in the with market cancer of as our ovarian demonstrated the second-line U.S. maintenance the our the share while on ovarian PARP XXXX progress PARP XXXX. as in with reimbursed opportunity we progress strong in continue Drugs EU Fund We're and focus second-line initial we additional EU overall. now Cancer the and to to with on seeing with later early on in Rubraca countries prepare cancer

In cash a for addition We updated to QX. progress, also showed Rubraca our in million $XX our sales we significant advanced presented reduction which in burn, to in we net data revenues mid-XXXX. with BRCAX/X-mutant and prostate in prostate U.S. XXXX QX planned cancer our beginning in for potential advanced September, cancer prostate NDA patients filing before year-end supplemental from is in the indication reduced

arm and remain the two part tumors. enthusiastic lucitanib open advanced combination very about about of we continue additional studies. BMS-sponsored an ovarian as possible with with advanced have includes in in discussions of solid Our cancer as one clinical gynecological with FRACTION other study with collaboration the as BMS one cancer for combination and well active now studies Opdivo to the now combination with We enrollment, Rubraca of Rubraca combination for Yervoy SEASTAR gastric and with potential study, Opdivo as advanced cancers other in

early initial have as meetings also of beginning We trials mid-XXXX. data next from medical year these as

has sponsored and In cancer reoccurred addition after in spread in with failure we lung stage to with of will non-small lucitanib chemotherapy Phase cell patients immunotherapy. by Opdivo IV or evaluate X/X combination combination studies BMS, that

of develop XB is the Pharmaceuticals and in modality field, preclinical opportunity expert ratings emerging potentially we're [ph] become FAP-XXXX in three collaboration, opportunity important this have therapies. and upto leader lastly, an through development tumor types. multiple we a about for by believe additional And we this to enthusiastic to the an the

that, with questions any And you happy be I'd have. to may answer

Operator

Kennen Markets. MacKay from Capital is line first Please the RBC go [Operator your instructions] question of ahead. And with

Kennen MacKay

my the congrats saw Last growth commentary of on some just for that. And narrowed question QX, some growth continued expect we In taking there. your on and commentary a that quarter Thanks question. you there. could provided we Dan, quarter, the quick positive guidance continued Hi. maybe and ahead.

wondering if is the of in prostate, again, QX? the of well how about broader to thinking a what in the really wondering were where strategy, patient be or some out these And conference of coming out there, different a as has combinations the very approaches focus? populations, on whether the from Just And therapy competitive that's QX feedback agents of other versus ESMO combo Europe? growth frontline ahead should majority we some been especially from these PARP of ovarian sort coming as Rubraca maybe U.S. taking secondly, coming I/O then, physicians bringing

Dan Muehl

end our Sure. of did up We the the in range lower guidance.

said, I States green some On starts the is We're see the in last optimistic. I think new we that And terms duration. patient to in in and of both numbers. of call, terms now seen commercial were QX shoots beginning in cautiously the United

and move making more their and physicians classmates class the therapy. beyond going observation growth continued the and we’re and for progress where effort lower the wait PARP we the effort and we’ve see that than to made being of us. with a guidance delivered note And And frankly those to growth to make the we're converting it physicians didn't we effort, You'll we progress effort cautioned and in that end field. consider convince hopefully in our that the is in quarter-by-quarter our same more our or But, markedly QX. progress active watch in for really patients, to this make many continued take everybody pleased what an remains higher

under reimbursement UK. launched the We do formally now, anticipate in as we

to to in UK were the may patients is that were who limited. recall, sort we of You X% the selling pretty pay, of private X% but

with October. Italy a launched year. and We launch the before in reimbursement UK, Now, anticipate the We first quarter. formally anticipate in we the of France launches in the in in end Spain

to will see sales we these So, European to from in begin growth our countries. contribution

As data say to those need to a at and enthusiasm greater benefit treated. The the and And for combination limited of take see also HRD enroll, beyond those potentially biomarker out looking important for the and years ESMO, two the X,XXX-patient somewhere came potential I this will this which probably deliver study for combination. regimen, And the commercially physicians population, strategy, can enrollment, presentations that high it’s in competing frontline trials will have in in speaks trial for presentations results, product the the that a for enrollment in trial in negative is population the for at and than there's for think, at curative enrollment less looking the which fully combinations the particularly in monotherapy the a really there to of but if duration especially to is of that the this available not and anything the that least rapid of class. of I Rubraca, enthusiasm as trial Opdivo. data light reaction to remains only been, as we’ll first populations a

Kennen MacKay

the of referring of the well, seemingly into some was in up I And terms ovarian, potentially of prostate, therapy moving for earlier in sort there as lines that post strategy maybe chemo of in Pat, think also to combination.

Patrick Mahaffy

medical combination community United focus other both meetings, instance much for about one-on-ones and then have PD-X Rubraca was with TRITONX so of in States. the by in enthusiasm a but ton at great not with conversation lot with the results the in at community ESMO oncology urology ESMO here of of prostate. on didn't There We

meaningfully improving treatment approved, men it out an it’s think with kind will that or in in I in if prostate. which of, targeted chemo more regimen of for to very seen is the all-comers community XX% think, and not given population. ovarian, of the slowly this than interesting, approved for a much about we're the maintenance think that, cap first going prostate. disease, now in if And a stage that gradually other rapid is one think particularly an enthusiasm be benefit for provide high. I targeted unlike population the having The excited adoption and a treatment may or agents we’ve see class And therapy in of the in I it adoption, we're is I that at XX% a advanced greater

Operator

America. next is Your Tazeen line ahead. of from of question the Please Ahmad go Bank with

Tazeen Ahmad

European ramp to can about U.S. dynamics We've have view ability Rubraca your wondering just uptake Pat, I share the impacted the have the about market. for of that in there talked some to while you a thoughts follow-up. with of your about now was just if the might thinking U.S. of the opportunity And and specific here in Thanks. how it some certain that the the be have I how market, dynamics ramps us then, versus you're European a about general

Patrick Mahaffy

following there competitor far, a and Yes. going will going and maintenance of to drive rate, It's in adopters to territory. the those similar to that the of take ovarian of and an have where example, some be U.S. peers higher. kind of that adoption some and be group us general, of thus both, take to nuances, effort own maintenance its In it's differ to appears our a kind by and of early XX% adoption second-line very is by

as and do us doing to Europe basis looks GSK around that the annualized a number interpret change they're XXX million. currency in It to an I on

in success still Europe mode in territories. and some penetrating, seen they've in launch they're in several So,

are a an fact us I setting. is to into physician represents these in the come the interested differentiated to committed for some a with approvals So, inhibitor in prescribing PARP maintenance offering territories second-line population as it in gain degree who and and we opportunity market think, of that there

certain BRCA. only States One that countries, for patients niraparib is reimbursed United beyond difference is compared to in the

half who the use RAC So, maintenance all patients in territories are an olaparib beyond in population. do for have only is second-line in mutant the reimbursed about approval BRCA they but

will competition for the -- for of continue limited niraparib. which to us and represent those patients, to be population, we XX% the BRCA compete patients, BRCA the wild-type to going plan patient is while to or So,

the So, the dynamic But, United there lower reimbursed much Europe, in sales States. the territory-by-territory. an by represents that to think were ZEJULA prices performance will there is be even fact at I a at in that compared different opportunity

forward we launches. to look these so, And

Tazeen Ahmad

the current And early did would about you of your you you prostate, force to organization opportunity prostate. your not some of at updated to organization, of some into sales your launch? what just you the for to sales what much areas move commercial or how you your get I commercial need thoughts if talked about then, on be increase about of thoughts would need. And you do the from whether And would you that early to wanted by focus kind more part think can do leverage any of need and

Patrick Mahaffy

Yes.

is leverage add our not We’re intent the into support commercial to now of prostate to going personnel the the And to all organization market. field-based United to in our launch. launch States

right and the us today that the is almost for the think, group always and larger at on be the centers, any of of primarily answer for be field abiraterone are situated to important address oncology clinics, provide educators but We academic allow to in at us able this in we will and to -- to the the may have a mix we group business MSL for regional medical nursing sales includes medical we increase of that address call have managers people adjacent will Rubraca. We account we around all centers and to physician organization well that prescribing level community, urology both do XXX primarily But, reps, medical have field the to which now. a not practices focus believe at oncology instance for slightly. but history staff a We dialogue for it the that commercial that medical administrative to inquiries. large the at nurse support the large enzalutamide are these, these within also And these course hospitals. able

Tazeen Ahmad

Okay. Thank you.

Patrick Mahaffy

You bet.

Operator

question Please next the of line Your Wang from Gena ahead. Barclays. with is go

Gena Wang

my questions. taking for you Thank

The little if is first Pat, one more by and patients by a the has how treatment drug? color since a longer wondering how this the commercial quarter just driven regarding can of much strong treatment the quarter, is was new or much duration give question, driven you

Patrick Mahaffy

It’s driver distinct hard pretty of view the is. quantitative you a what to give primary

free with the particularly patient new the given be reduction of starts, or and seeing, patients, in are to new fair, the pleased [ph] duration know increments. seven But, it’s to the patients and program. months, modest months. duration probably in seven improve of commercial are continues relatively drug use FAP who it’s starts through now definitely to we’re the The over getting of patient We percentage modest that amount half access number patients we somewhere of is between -- around

So, we improve. think it’s to continuing

tolerability. is we or that, general a a of It have speak the things talked they Rubraca, lot go off one oncology United continuous progressive of in does this States, continues. seeing general benefit disease, effects in XX% that face go the being on to see about in tolerability as So, just flies Rubraca. of to because off may that we increase therapy difficulty The we're just kind duration that side therapy because of will only the because about having speaks treatment. in the fact of they're

Gena Wang

just XQ Okay. ‘XX, trial, in data. I question wondering, the prostate wondering already is XKD cancer started having the have CHECKMATE in should that And see we when then, second trial

Patrick Mahaffy

Don't that. an have answer really for

them. data them, relation any with have reported but on collaboration the that We are is say. clinical management charge in time a of to they any in that be close from Bristol-Myers great and to a have trial trial, predicted to for going of both, enrollment We don't that ability really And trial.

Gena Wang

enrollment? many enrolled rephrase, I enrolling can patients, already you patients Maybe is sense and share us or with benefit like have a the how that trial you still do like

Patrick Mahaffy

certainly pretty their will with ClinicalTrials.gov comfortable enrollment, that report of speak trial would And imagine completed does. they would to go that and enroll. our up No. trial letting have when on Bristol-Myers The We're it policy we and when that activities. continue I as to does

Operator

from is line JPMorgan. with question Kasimov next ahead. go of Cory Your Please the

Unidentified Analyst

questions. get kind market on challenging, for Does well Astra a This in competitive in trying on FPS prostate the Hi. you? Thank Thanks prostate thoughts seen. to randomized viewing trial, that TRITONX landscape our this with Gavin potential for on enough as Cory. more timeframe, of there. are you data make or you that is in with similar but the How one data are actually. taking We just had look the we've confident your a

Patrick Mahaffy

Yes.

in be market for us timeframe. two if a will to There can't when know they that going So, XXXX. of approved. approved likely or sure you're in as consistent But, be are we on And the we matter we're relatively right. opining will be for when

true the of It based of randomized will approval It in also true number trial. a NDA or package their PFS, that to based their package, same will lower trial be the their BRCAX/X on in patients number be that is terms be on of patients. is going treated that slightly in

of come it that to advantage data will to to what in submitted set compared is still an be that be by think the I a with necessarily year. end limited the So, going fairly package isn't the

to understand treating these to endpoints is what to response going physicians. the is is really evidence little patients which to want As both are versus easier rate is, tumor see. they it's for PFS reality a Response away, rate, important because that

fact on response, is and important both on what is inside thinks we which a and like that endpoint happening further, patients And than believed more about his body. abstract will how never I've treating will focus is physicians more certainly the our PSA in what's somewhat So, probably response. focus patient PFS

discussion. confident this on not that earlier That But, I matter, advanced, or their see I'm of We did is for in sadly, they're stage most think about for ESMO. the patients AstraZeneca treatment. would in a data Now, and those subject it's be benefit how physicians will will imagine that be mostly their any good. even progression presentation the the given prostate at PSA publications. and cancer seeing

Operator

question next of Choi line Your Sachs. from is with Paul Goldman the

Paul Choi

on lucitanib. pipeline two questions had I

but sacituzumab year could from think, that First, was potentially would heard the SEASTAR Pat, say with what mid But, wondering, be seen for study. I I I also well? govitecan if initial next data the you what Rubraca there? the we earlier is combination of potential be in gating see sort a that something factor not, arm as the XXXX Is could ADC? the with timing And

Patrick Mahaffy

that lucitanib expect hope be said lucitanib to would data for middle to I -- -- see just think, clear, XXXX. both, and of to for I see Rubraca, Opdivo by we plus plus

clear, two were populations there for to data. hope have be which to we or regimens So,

extent think team have with with has the Immunomedics We team when Immunomedics. we go to don't data what the had would dialogue know and with much we combination discuss I and the to for have

initial date. So, I'm see before a going But, to would not combination. hope would going the I you I'm of not give year. date data you to we a that for next give end

Paul Choi

you Phase trials dose lucitanib position for Is nivolumab, Thank to go regard in since then, about lucitanib the have would trials for that. from questions. I quickly. And you XX down think you Okay, the to should prior to for that indicates starting for relatively much great. talk a combination? about way portion your Thank you of be XX I portion with taking our X I combination the the for dosed it? And potentially think in X mgs go-forward guess, clin guess, mgs, mgs visibility the dose expansion forward would to X be with Phase you very I down think that start. it to the when dose sort dose initial And on QD the right nivolumab

Patrick Mahaffy

bet. You

was You're end dose By X have the expansion is of monotherapy next mgs. right. was would mgs will at XX of and dose level. gynecological one in forward cohorts least was And would initiate and X the when as lower My we time the dose It the between choose we go and mgs. year, up And the year, what we early other both the X-mg tumors. treated ultimately mgs, with end of X-mgs X that our dose this belief at expectation dose. we’ll than the that dose. we the go chose solid Starting purposely that the be would year, around patients

guesstimate that [indiscernible] we the the sure dose and aware time the February do at cohorts, dose-expansion does, those a beginning to forward. kind going choose is cohorts. we but make be everyone of or would expansion we the to At one be we would and are the I But, that's general at fact call would pipeline of move chose, two time, we at of that general doses our would, initiate

Operator

[Operator SVB of from Please Leerink. Berens line the with Instructions] Your next go is question Andrew ahead.

Andrew Berens

and to regards expectations they actually are Lynparza. what their commercial ATM a little wanted the if the get for prostate opportunity Hi, Pat. on their applications, potential deeper and to just your What label in Thanks. label? ATM into are go I

Patrick Mahaffy

have to they way make about opportunity don't think populations, or make if don't These going they on going the I be they are to patients they’re they're BRCA treat ATM same and going in choice the they patients. treat of have have distinct how how will So, physicians impact any mutant-BRCA to if ATM. choice about ATM the

for the the them, double them, potentially for number population of PARP XX% for from XX%. to that and total be therapy TRITONX, patients to would mutant-BRCA inhibitor just eligible something of for like ATM Obviously not us a XX% for would from nearly

as Its I important. it’s on think opportunity, impact commercial limited. population BRCA will be So, the a

in it with data or whether to happen ESMO. us about TRITONX. to As think they for implications us hard their get we label at may it’s important the for how it's what as not, has interpret it represented to And because they

of we're approval But, So, kind the of they well, We for this would never case, conflicted. for be think good based in competitors. filing of obviously because hope that get in because them context us on ATM I we're wish I TRITONX. kind

does they end their ATM the the population of in matter? it of and what patients primary So in So, issue the is, big definitely is BRCA point benefit combination hit ATM population.

would So, at PFS. how median pretty that’s going we in we to It's for those of similar going the go it, median, ratios dissect terms BRCA fact they didn't showed and to ATM, benefit or consistent at not didn't in for to that they're hit responses going median, were to of they're benefit this hit all-comers as can't count distinct case FDA helpful the reported really it's ATM, When the curves to The disease see curve, Kaplan-Meier thing number those one because point we so progressive the the the at for censored and ATM is. see reasonable radiological see they others to data it spike with in subset were expect, data The be reported for whether of look ATM and being results of there olaparib. but one with in it. really patients or at progression. hazard ATM much. interpret got BRCA have is determine what if didn't populations, that a they be never and we've so up whether or the BRCAX you to and individually because that, as was dropouts look would all-comers the PSA but -- the on superb to decide populations And that

them FDA’s show reasonably ATM to those that's a going population. number ESMO impact to on at the number, view able interpret if we didn't benefit in So, they the is data; high weren't that But, of

Andrew Berens

or is it may these on on like get efficacy, physicians the be that the differences more is Thanks feel color. there they basically safety could to be tolerability? sense get drugs active cancer are same the physicians that like if going label, of prostate Lynparza from a and ovarian do for you be or in some where drug there a ATM perception Do the that Okay. most

Patrick Mahaffy

I unapproved is second-line almost that indication, class a for latter. this abiraterone inhibitors sway think that in belief for indistinguishable to the PFS PFS don't active versus patients. these benefit not, PARP to it’s [indiscernible] a are ATM going benefit, all and I sure that of enzalutamide as anybody's modest and evidence going be agent an and

going seen as I similar. be to think, generally they're

Andrew Berens

then, one FDA you availability PFS And prostate. drug change at could Do set randomized think with trial Okay. endpoint? of last one a the a from just a bar based on the on

Patrick Mahaffy

approval that So, I very for I We're actually the think don't data note sets we've lot them? dialogue on FDA and may data full set, and versus a limited pre-sNDA meeting if set, you're approval data approval, QUADRA about good -- we for a about the that. full have an to have is encouraging was confident, the you exceptionally based say a that related that instance asking which presented it to highly achieved that. that on they accelerated with

discretion. So, FDA has of a lot

Andrew Berens

program? give one we queue. drugs, in that jump free question forward? overall and just the that going I’ll just see an us color should in is Is in other and then, the last assistance drug trend in it you And on patient sustainable decrease some back the Okay. the Could market

Patrick Mahaffy

modest to a If there from see in the you is it’s trend, reduction use XX% path a XX%. of

dramatic. it’s not So,

For average us, year. isn't important, it XX% on what's the saw we last

I to for options two see for assistance patients. it closely one continue Rubraca, ensure think, for worked second provider reasons, and of is, to are in the ovarian we've multiple specific to line at we down case reimbursement third-party they program with our actively this really going our to slowly looking go are

are the better program eligible really we've think of don't ensuring a job I so, program. not the for who done from And those benefit

free who the been foundation, to ovarian, there bit it and make a our that isn't existent and those get QX little the of it day every co-pay of January funding if efforts this on drug, in some through for is, then, not. fact who do has the intermittent that provide So, to foundation. don't, after truly the but every those year, assistance at sure, dried foundations post of And not check at that quarter and second needed, most XXXX. is majority was providers of in This up day it, funding of all funding the last patients the do us but year, not recent

ovarian Medicare in So, some cancer. additional to with support has patients been available

Andrew Berens

do have question, Okay. if me. one And more just I allow you

beyond. sacituzumab about with being you You as limit XXXX in program or overlapping guys thinking Immunomedics of the dosing are tox and What something type protocol at… the to some of mentioned

Patrick Mahaffy

is might I -- year. First, But you the I’ll next XXXX. Lindsey, don’t And just if what of commit you. the the end say, I the 'XX better, said hope question? be end dosing want phone. we that's of answer Lindsey end the said before data on it I strategy is to had by I of

Dr. Lindsey Rolfe

Yes.

Pat. Andy. welcome, You’re for question, Thanks the

I toxicities, means potential and and are dose the will our we a sacituzumab would of both that lower start that forward forward, not necessary. trial. way the overlapping anticipate clinical very with make in as be You're And, adjusting right. both that doses one drugs, But, of this path. we would of There rucaparib straight

Andrew Berens

in setting, maintenance-type it cancer? be like a Could line ovarian Okay.

Dr. Lindsey Rolfe

Ultimately, is a standard in therapies. we moment that who could consider we're the patients doing the that. have But, the exhausted treatment Xb practical Phase portion that looks trial at

Andrew Berens

top-line Okay. and shrinking all the on expenses. the and Thanks congrats questions, the growing guys, for

Patrick Mahaffy

Thank you.

Operator

from Your line of Please Joe the go Jaffray. Piper next is question ahead. Catanzaro with

Joe Catanzaro

Hey, guys. here. Thanks quarter on the for nice congrats the and taking question,

quick Just ATHENA. here a one on

or PARP I'm So, from design maintenance. we’ve of your allows arms talking any preceded incorporate with standard patients adaptive with of them seen how And to you're BRCA expectations? adjust BRCA that some in to I'm trials just seeing combination of sort frontline enrollment how and sort about of whether patients, maintenance line And them ATHENA on curious on they BRCA care other enrolling evolves. patients enrolling competitive based non-PARP receiving physicians has terms and potentially evidence in randomize

Patrick Mahaffy

Lindsey?

Dr. Lindsey Rolfe

standard in many So, very maintenance ATHENA some of is it’s with enrolling In disease, is as available in and countries, for patients other of countries, many countries. frontline not. inhibitor care PARP

other available, speaking, no risks where the designed minimize overall, where less we’re Pat that wild-type there or of therapy But results to expected countries in ITP, seeing strong and to for success. associated with on BRCA PARP at but standard studies enrollments in only PARP BRCA level. seeing any analysis generally correspondingly BRCA maintenance countries we’re based the described available trial well-positioned the with the from in inhibitors, not statistical confident then, frequently. is inhibitor And in that positive we're that. I'm is patients HRD also So, the And HRP rapid in is frontline enrollment above

Joe Catanzaro

utilization. just for Dan on maybe one quick then, cash And one

that go to in or operations onetime in what items we So, some this should continue we with saw net were away? line quarter expect will cash there along

Dan Muehl

we've of volatility No the quarter. end burn last second one into to call. time cash of -- half items range previously necessarily. But, address we on some guided our the lower by a to give to tried But, ‘XX

so, before. compared won’t necessarily be what But, to a it lower rate was at And it's it the same. exactly

Operator

And with question today's Please Securities. the Schmidt line Michael come final Guggenheim will from go ahead. of

UnidentifiedAnalyst

questions. Hey. quick Thanks taking This CZ Good morning. two is [ph] for on questions Maybe TRITONX. Michael. our for on

You previously RECIST said FDA would want to for run sNDA. XXX patients the BRCA evaluable

October, on TRITONX. noticed interaction enrolling we latest sites And are then, NDA package? patients based there wondering, also your the patients in FDA you be included targeting for with Just the still are to XXX some in European clinical

your Are require do well X… you what's strategy if EMA can understand help as Just -- confirmatory or wondering to TRITONX EU specifically, prostate -- your Phase you cancer. submit us you they for to more are going

Patrick Mahaffy

Yes.

it's to think, number call, the I For May going we said in in the our be range beginning patients, XXX. of of

But we given that available have pre-sNDA to you should successful precise is given number. our acceptable the we So, the meeting FDA, haven't for that assume sNDA number a and.

patients are As site, we in in for TRITONX. in Europe enrolling for European TRITONX, that the yes, matter and

the arm can that involved something an more approach studies TRITONX us are be and not much ultimate U.S. TRITONX. for of the you’re to We assuming as optimistic But going data enough on be basis a approval, to as we discussion. a a for TRITONX the of in basis we the of number not is use approval But is is EMA robust to single that profoundly submission are set the an aware supporting and that an the the and we’ll EU EMA may basis, for will also TRITONX patients We EMA from use it’s in with that likely large be submission. near-term TRITONX going as

Operator

no further are And closing questions. at any this time, comments? have there you Do

Breanna Burkart

Simon. Thanks,

Clovis. we So, of all you in interest for thank your

website, good on a questions, call available XXX-XXX-XXXX. our in replay hour. call you or at you and at Thank Anna If about XXX-XXX-XXXX follow-up any at The webcast have me clovisoncology.com, the beginning have an via will be please day.

Operator

Clovis Ladies earnings Thank and you XXXX joining. quarter gentlemen, that third call. concludes conference for Oncology the

disconnect. may You now

Clovis Oncology (CLVSQ) 7 Nov 192019 Q3 Earnings call transcript