CLVS - Earnings call transcript Q3 2021

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

Operator

Good morning. My name is Julienne, and I will be your conference operator today. At this time, I would like to welcome everyone to Clovis Oncology Q3 2021 Operating Results Webcast and Conference call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. you. Thank Instructions] [Operator President, Corporate Vice begin you your conference. Investor Sussman, Communications, Relations, may Anna

Anna Sussman

Good Welcome for morning, Oncology Julienne. you, Thank everyone. XXXX Call. Third to Conference Thank us. you joining Quarter Clovis the

on this seen and it’s press You’ve our likely morning’s website. if release, not, available

our Lindsey discuss Officer, detail. be call for As Dr. financial for may the and Today’s then, available questions. our Chief conference archive will Tom targeted greater our clinical Dan next webcast. this will in our President and milestones of an cover Mahaffy, CEO, our Pat, development Patrick Rolfe, several the Officer, includes will on and Dan, and upcoming reminder, highlights Financial radionuclide Patrick agenda our is being the present available will be few and make live a FAP-XXXX; the and the and and website the Chief a during weeks. time, today’s quarter’s Q&A, then, answer recorded call Remarks discuss accessed following, FAP-XXXX during will on update the in Dr. Rubraca Muehl, Chief programs; to update; corporate Tom open Harding, Medical results for anticipated will be we’ll our remarks. which Officer, then And Lindsay will closing therapy call Scientific

those could laws, the results the expected securities today’s and these differ we and forward-looking that cause make may All are federal within statements financial during in meaning from call, to note to conference statements we statements. that of please actual risks plans. materially Before begin, forward-looking statements concerning uncertainties described business the subject outlook including our

the risks uncertainties of the SEC recent differ refer business. and of with of the to timing full to Please for a and associated factors, and our extent and the of actual results our duration materially COVID-XX recovery of a it. due pandemic review Our from including could the effects filings extent with number the

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

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

I’ll over Patrick Now, Mahaffy. turn call the to

Patrick Mahaffy

Good Anna. We Thanks, to pandemic an appreciate taking XXXX were Sales and million, QX hear ovarian to being QX morning, time us [Technical you everybody increase the to and over welcome. Difficulty] in XXXX. of in the quarter the X% due $XX.X patients prior primarily X% Difficulty] United cancer fewer during States. the compared for treated and lower year-over-year year-over-year [Technical diagnosed today.

available [Technical believe line maintenance continue to line the ovarian be believe grows, as data is for call Rubraca quarterly in often will the of consistent us, with [Technical manage the Difficulty] increase the averages treatment of another XX% maintenance do and will to COVID-XX, We the and of our impact Difficulty] second market we that this based the XXXX experience fatal on pandemic. performance. second European Our maintained have cancer Despite Difficulty] monthly rise continuing the of Difficulty] setting ovarian [Technical we patients urgent U.S. prior [Technical we Rubraca. to share when disease need cancer use to

earlier castration [Technical first-line monotherapy to see clinical and of to treatment ovarian second-line in make United of Difficulty] XXXX; Rubraca Lindsey in half Rubraca provide of readouts lines program. we populations clinical States opportunity Difficulty] advancement second Three XXXX. for These for of sales anticipated shortly. are And Opdivo with ovarian in Rubraca in ATHENA X cancer in therapy combination ovarian [Technical in both, data the potentially these ovarian and our progress cancer maintenance for treatment prostate resistant cancer. monotherapy and Europe. trials cancer, Importantly, larger XXXX: in on larger treatment the provide the QX ATHENA a first-line for line in Rubraca first trial update will in prostate and trials in maintenance XXXX; in maintenance metastatic both potential patient Phase address significant continued TRITONX an we’ve

for peptide transformational XXXX a nuclide continue In lead clinical field development, ourselves will [Technical seek be some our and addition FAP-XXXX, Difficulty] therapeutic our [Technical oncology the the to anticipate and pipeline continue importantly, to we emerging assay targeted Difficulty] to radionuclide program, Difficulty] of therapy advance as development. program. we [Technical in this first Difficulty] enter we to as [Technical leading

are first dose from a X of the LuMIERE X presentations During And FAP-XXXX, initiate meetings. medical XXXX, to of expected data of will following detail developments Phase and expect in X also recommended expansion we speak Lindsey Tom Phase study the at of the FAP-XXXX in cohorts. LuMIERE program. Phase more identification the

Harding, debt in to million financials the convertible $XX.X will offering FAP-XXXX speak Chief the to Lastly, amount $XX.X our and our now have in therapeutic August due for in XXXX. third to Scientific to radionuclide over retiring turn now, greater of Officer, we We programs. Dr. to through that September, addition call program. in And detail notes in development in I’m years quarter, almost the also our pleased raised Dan I’ll discuss no Thomas announce equity XXXX at-the-market million the the targeted proceeds principal shortly. remaining net in three

Dr. Tom Harding

to speak Thanks, today. Pat. you pleasure to a It’s Hello.

a or XXXX collaboration Pat fibroblast activation therapy Pharmaceuticals our emerging peptide-targeted has in key resistance. a of play or PTRT, on first CAFs highly the that the FAP in which program. tumors with As of part targeting role abundant cancer protein, in are this mentioned, radiotherapy represent FAP-XXXX, we’ve progression, compound transformational calls, lead in and for the And critical cell expressed focus. as to a CAFs, is tumor potential as most the initiation, development. clinical candidate, therapeutic fibroblasts strategy discussed is radionuclide targeted metastasis leader be our on cancer-associated is majority as also known types. of radio-therapeutic in XB found as targeted prior FAP ongoing licensed one components

expression were non-clinical pancreatic tumor tumor have in immunohistochemistry. such in FAP pleased present October, high blockade. studies FAP solid and that a conference of expression predominantly and observed stage most surrounding activity or expression salivary recent [ph] localized both or was primary. grade. CAFs was potent tumor The cells and also was AACR-NCI-EORTC lung, immunosuppressive demonstrated to was in independent recent gland, FAP can metastatic primary as mesothelioma, tumor At tumor ductal sarcoma, non-clinical data the exhibit detected therapies high multiple the we across of head progression squamous and immune-based example, neck PD-X analysis in samples using expression For cancers into levels In well to confirmed as to types the confer types, screened types, tumor and FAP PDL-X the promote colon, resistance FAP integrated in microenvironment. these squamous cell as tumor that non-small adenocarcinoma, expression cancers that High tumor of CAFs bladder, unknown demonstrated

in Phase addition tumor the was of data mesothelioma, cohorts the in These In of FAP addition, expansion X expression observed cancers mesenchymal in including of sarcoma planned cancer-associated support multiple to fibroblasts. LuMIERE. FAP-XXXX in investigation origin cells and types tumor in

LuMIERE radionuclide into position we As pleased are clinic would grows tapping with a patients, FAP-XXXX interest target increases development in we Clinically, monotherapy ongoing first Difficulty] mover and study. peptide-targeted focused the greater a to are in describe and first be FAP-XXXX therapy [Technical FAP as as in the larger, Lindsey the in on field detail.

we’re pre-clinically, a evaluating However, FAP-XXXX number combinations. drug of

such therapies agents Given CAFs new the blockade, PD-X will in with PDL-X priority. role FAP of resistance base combination as a expressing to or be mediating these

FAP-XXXX evaluating antibody in a PD-X action syngeneic the studies non-clinical and We are mechanism mouse tumor currently monoclonal of in efficacy and of models.

immune targeted to cell data will die. are the publications inhibitors, sense, to If number is a repaired, checkpoint an addition damage causing the this eventually makes radioactive inhibitors This reporting of since radiotherapy DNA In radiotherapies efficacy. not of by with for damage emission. combination augment work there by non-clinical PARP

in critical radiotherapy inhibition One proteins combination of agents. repairing and its targeted multiple PARP with is the damage augments radiation-induced efficacy for

We’re of evaluating inhibitor with models. our in FAP-XXXX preclinically currently PARP tumor the combination rucaparib

to specific of synergize standard radiation with number a as agents in approved known or currently Lastly, indications. care candidates is of

used a carcinomas chemotherapy utility is first-line well-known pancreatic have in and and as other radiosensitizer cancer For could FAP-XXXX. a example, in gemcitabine, combination with

oncology work emerging our targeted commitment currently throughput approved screening educational to We’re with combinations to drugs of scientific have combination created To field, of radiotherapy. forward in about promising this meetings. a We development. to reporting this look performing support at upcoming to identify materials radiation high XXXX we results preclinical

ITM want program. agreement information these to provide and about clinical development no-carrier-added recently provides for I of more, to introductory completed supply first this the place. therapeutic agreement ITM’s lutetium-XXX please of this for ensuring an development To note integral Clovis microsite clinical pleased materials Clovis’ targeted in of in program. five FAP-XXXX to supply the targeted we that The visit targetedradiotherapy.com. And is that video also a more the years, with with success radiotherapy, have are FAP-XXXX we learn to next have radioisotope, use quickly and are EndolucinBeta, radionuclide

targets discovery for for a candidate currently three to this second expect rights. at in collaborating IND therapeutic global which Pharmaceuticals additional of the we to have XB second we’re with targeted directed file program radionuclide in an Lastly, program on We half XXXX. development

Lindsey the over call turn update. clinical for Now, I’ll to a

Dr. Lindsey Rolfe

the of I’m everyone. be on really the expecting Rubraca discuss here of ATHENA today XXXX, the XXXX, portfolio. from versus quarter half the across and based protocol-defined we’re clinical assumptions. our projections. expected arm event-based of data with Rubraca, morning, glad to from are arm in the key based plus Tom. combination to Thanks clinical line milestones second on first clinical Good Data you programs monotherapy Opdivo current top in monotherapy

we second Phase the file study ovarian This to of are as lines opportunity As positioned quarter of readouts, available, data potential TRITONX over Rubraca European results trial newly shortly the trial and well to ATM plan sNDA the the we therapy And We Rubraca evaluate antigen patient an reminder, any shortly variation population Opdivo ATHENA is expansion. study ATHENA Continuing ATHENA reach a and Monotherapy mCRPC as outcomes: results complementary independent first-line combination with now from Rubraca we label an differentiate Rubraca monotherapy, an the and alone second-line believe of in second-line in or prostate versus evaluating the or in is setting is top-line potential maintenance versus potential mutations. indication ovarian BRCA with to of three same truly in first-line the to to and for currently deprivation X,XXX-patient the front-line X choice of in ATHENA, two TRITONX with These MAA chemotherapy in available. the study top-line for patients sNDA is well advantage the in later-line serve offers earlier maintenance both, a provide current milestones approval in a With data thereafter. cancers, for therapy to are terms to are maintenance in diagnosed monotherapy after file of anticipated expected believe setting. XXXX. cancer study which placebo expected first-line physician’s a the for X as mid-term Rubraca Rubraca Phase a Rubraca’s prostate indications. plan in as setting. are larger combination, Rubraca, approved TRITONX maintenance. as Once this advanced we uniquely

survival occurrence the As progress-free timing for of is a upon the data protocol specified reminder, readout contingent events. each

activity Lastly Rubraca with on the repair we in or the a DNA hit tumor response pan-tumor ongoing for patients BRCA other mutation or tumors study, X double see study, Rubraca, biallelic genes. Phase evaluate with results target various LODESTAR in to repair Based solid with homologous initial recombination from evidence the to study in patients encouraging mutations. our

genotypes, have Importantly, the and biallelic loss. tumors BRCA mutated breast, the other certain of pancreatic majority

We more. to and time update development as and an potential provide we evaluate path, continuing are regulatory line know we’ll

underway. as the to study, cancer cohorts continued next. provided non-clinical LuMIERE the described forward FAP-XXXX undertaken theranostics. the to work Let I’d discuss Stage the ongoing cancers. each enrollment and lucitanib in X me our overview Stage at endometrial work in and Phase were potential of FAP-XXXX now imaging cervical the In an the dataset. are for lucitanib, like briefly They presenting it, and evaluating cohort to by I’ll gynecological often meetings. of support a is a X Stage future these to paths program data We and clear both, advance Thomas a therapeutic sufficient we of our review clinical agent, an LIO-X X. as to LIO-X medical forward used responses Opdivo concept cervical in supported agent discuss X look of encouraging combination and cell study

the to agent, or inclusion PET for allow attached the positron selection in patients study. isotope of to is FAP-XXXX imaging tomography imaging So, emission gallium-XX and the

For death. is The attached cohort the lutetium-XXX, isotope continues anticipated emitter the enrolling the therapeutic FAP-XXXX cell this particle patients, damage is portion dose study the ionizing an and quarter. to of being enroll to causes second LuMIERE that radiation of Phase to agent, beta and DNA X

next for reminder, is this a study last period enrolled each of the it’s to sequentially dose cohort. first that the follow-up dose As this safe man patient study, to the safety has ensure being with five each after in escalation cohorts with a dose to a six-week enrolled move cohort

radiotherapies. classes of targeted agents, this period While than is is for Phase in other longer of standard oncology it trials six-week X

safety determination tumor in are Phase types, a in recommended X X dose, the begin cohorts and of FAP-XXXX multiple expected Phase and XXXX. the are expansion evaluation, planned Following to of

our program, generating and the study, is cohorts. along at imaging In we’re to with UCSF currently inform selection a expected of with from rolling tumor are our for underway Results help is investigator X tumor multiple separate addition patients. data expression Phase study to sponsored expansion types, in evaluate own this types FAP FAP-XXXX preclinical to

control While presentation submit we timing at for quarters. the the data understand data not next in medical that few meeting study, will the UCSF do initial a we disclosure imaging for of

the of of other we initiating X with launch combination first medicine to Phase of compounds. program, nuclear cohorts at medical addition XXXX, from milestones data explore Phase key In LuMIERE presentation study focused oncology expansion several including to oncology and the combination LuMIERE meetings, X FAP-XXXX during the in anticipate program our

Given FAP is expressing PDL-X with of the or a exploring mediating priority. PD-X in combination blockade role tasks immunosuppression, the

for dedicated our we of planned isotope linked is I are in for by would combination combinations XXXX. for animal to trials with choice development. potential clinical filing results. again recognize turn over discuss employees, our models as FAP-XXXX the for in noted preclinical inform the And our to of patient advance. Tom, a programs to efforts an clinical involved multiple financial clinical As the third studies And and that, Dan exploring to call both the participants IND to I’ll like [ph] teams investigators, quarter

Dan Muehl

for $XX.X revenues QX product Rubraca hello included million net reported net everyone. $X.X U.S. We and which and product Thanks, Lindsey, revenues revenues million of ex-U.S. product $XX.X in million. of of XXXX net

in an the of of totaled in million net million, U.S. QX in XX.X% compared revenue in main mix U.S. to U.S. a million product for quarter XXXX product But, ex-U.S. which Gross million, driver. Third X% net months the estimate of for $XX.X QX compared for discounts product revenues nine represent decrease $XXX.X XX% XX% $XX.X quarter, product $X.X revenue Rubraca the product and ex-U.S. XXXX QX of quarter net in net $XXX.X revenue X% which million, product reported and million. of revenues. and metric depending the revenue ended Europe. increase likely, of to for period XX, over September the net to revenue product fluctuates net Clovis seems net included revenue the included U.S. and XXXX, million $XX.X globally $XXX.X XXXX. to of it’s U.S. and QX million the in our $XX.X This revenues $XX.X XXXX, on adjustments level of revenue future ex-U.S. million. we distribution difficult net revenues the reported same and were to high which of XXXX Decreased XXXX, to including compared and

the million in will development proportion the totaled GTN lower Research to correspondingly. and As clinical comparable due XXXX, for down U.S., primarily trials. global XXXX, as million QX discussed, Rubraca European to $XX.X increase on for compared $XX.X increase previously in expenses revenues XX%, to spending period

in due full compared personnel XXXX XXXX for million in and organization expenses down year research year QX $XX.X per of Further, in net expect decrease $X.XX $XX.X reported compared to We comparable for to compensation size in expense, of to million XXXX U.S. share. during our XXXX, for of a net share-based compared We general commercial share, a to administrative expenses we the the million in a expenses to QX XX%, and XXXX, of period full and in the the loss to for legal or costs decrease compared be SG&A and XXXX, third to of XXXX. fourth development $X.XX decrease reduction quarter quarter a $XX.X totaled expect $XX.X or XXXX. Selling, million expenses. lower per the loss

of Turning now cash discussion a and debt. to

of million in cash $XXX.X had September we XXth, and As equivalents.

During through shares our of at-the-market common $XX.X program, million we capacity has million equity quarter, in stock. raised the the XXX of offering net which proceeds

principal in convertible X.X% also at the full remaining We paid off in our in amount maturity of $XX.X notes million XXXX. due outstanding

convertible for drawn of conversion X, as next expenses the had Sixth to and to under the $XXX.X $XX.X is to the for million debt a $X.XX LLC we had agreement August XXXX draw up almost of a $X.XX Partners, not of maturity under ATHENA is financing Our remainder. ATHENA September Street for three years clinical price and with million approximately of trial. due Also and portion the XXth, fund trial available

or down mostly in million cash was used be between $XX.X XXXX. XXXX. to $X.X reported XXXX, in XXXX. in from million QX drawn $XX.X in million XXXX and QX QX million was $XX.X, QX for million XX% $XX.X burn from activities this QX XXXX operating X% expect $XX.X the We down QX Net down Cash

years, most $XX.X prior and We expense or XX%. recently have by considerably reduced SG&A million, both, expenses and reduced our SG&A to compared R&D R&D

and on continue reduced have Form to aggressively this as for and strong focus plan XX have we year, As revenue the in on next financing moving least will our you at sufficient forward. agreement period available cash the for have over our time, we liquidity based estimates, and XX, be to XX-Q ending current our fund burn our expenses ATHENA we the At this months. a cash operating last will disclosed can current September see, under

impact that. our diagnoses, we we to sheet predict in We believe cash revenue impact plan of as ovarian adequate the maintain with COVID Rubraca operating we what And is availability on with environment. there beyond management accuracy within variations provide and cost on quarter. situation potential to related this guidance cash revenues, consistent cannot mostly last sufficient cancer adjust the sources mitigate However, This Rubraca’s the our stated focus of is continuing financing. and revenues noted, timing of challenging to of balance unpredictable expected to flexibility our in and controls

turn I’ll Now, Pat. back the to call

Patrick Mahaffy

these Dan. set important for a year times, Despite the we Thanks, challenging have come. stage very to

studies Rubraca Rubraca’s During XXXX, top the Phase ovarian line adding inform data the potential three Rubraca to we’re that track to X offer maintenance [Technical inhibitor Difficulty] cancer first-line Difficulty] [Technical that [Technical treatment Difficulty] progression-free setting a therapy including checkpoint extends whether on expansion for and definitively study in announce a should survival benefit.

targeted we peptide sheet questions have. stability. begin improving [Technical the we’ll study our transformational X initial targeting and growth; be on as development to strategies, to happy development. support clinical program. financial leader study Rubraca our Phase LuMIERE addition execute our long-term present the radionuclide to X/X that, emerge to the efforts intend with lead FAP-XXXX, In label three and We first targeted data significant continued answer of advance and balance a core FAP These revenue Phase our for be may our Clovis’ program, may if targeted anticipated achieve for our any radiotherapy maintain you And drive combination as to therapy; is in Difficulty] radionuclide enter therapy and pipeline the XXXX we expand events progress

Operator

Your first Morgan. question Cory Instructions] comes from from [Operator Kasimov JP

Gavin Scott

Gavin our is on Hi. Thanks this morning. for This taking questions for Cory.

perspective radionuclide strategy to you. on others joining the the a and to differentiate program. on get Interested your one the XXXX. your get field Just level and higher on ahead thoughts Thank

Patrick Mahaffy

any then Tom of company first third the I’ll with given that, being in, has disadvantages the of may being which is third at of us, endured. first all and shot jump Rubraca, to a learned and market Lindsey too. take our have benefits being you If experience and

yet benefit us are types with to As a informed that the us important by the multiple know stays things for pursuing first development know of tumor, that don’t it targeted and to keeps we and may XXXX in us drug, we an know effective keeps in two ingredients tumor know only we’re We of sure. and but first, an what first this this add consequence, the program actively everything to gets for know potential XXXX. We a we are but really monotherapy not most combinations keeps for couple need the tumor, aggressive the radionuclide. those about

and So, for antitumor in about you of to to address happening? field about consequence, to importance would are we as the target drug what you our others with and effect. a is Tom, talk that? potential add and optimistic significant do a the the What the else hopefully target, meaningful that want

Dr. Tom Harding

Pat. Sure, Yes.

As so therapy death. can of the effective targeted the occur Pat is the and cause emissions an mentioned, cell to stay and core a radioactive constituent ability persist, in tumor radionuclide

the the limitation in is these drugs retention major different low agents development which upon all target FAP. very But, of tumor time, targeting they of FAP. aware based of in We’re they XX-plus a way have

Pharmaceuticals, for FAP gives tumor us expertise We’re XB small molecule-based using is retention profile constrained radiotracers. antitumor of which our efficacy different in to which XXXX, tumor fundamentally also which of a partner -- preclinical a a terms compared approach is peptide differentiated ring, and

and first we Anything drivers. begin one have our differentiated said Lindsey? core to with, Pat of trying agent. what that, our to else in a about on is maintaining addition, position top And So move of

Dr. Lindsey Rolfe

stable we biotech a And uniquely Well, for we’ve while. a and company, agile quite been are small are around very positioned very I’d and teams but just say our development that that experienced. we’re clinical

fast. to efficiently and execute in are a position really we clinical the trials So, good

Operator

from next Sachs. Your Choi Instructions] comes question Paul [Operator Goldman from

Paul Choi

questions well. couple me of as pipeline A from

be similar maybe here? FAP-XXXX. on will allow meeting that does population And design enroll population more expect relatively triple patients? the of shown you’ve LuMIERE with or we the in patient for narrowing as poster what you Can to your patient trial specification First the

Patrick Mahaffy

Lindsey?

Dr. Lindsey Rolfe

of as is know, not On [Technical Difficulty]… the study, Difficulty] the portion the you Phase the type limiting X tumor [Technical for

Anna Sussman

that? out. you it I repeat think faded could Lindsey,

Dr. Lindsey Rolfe

Okay.

Phase to X limit is look so we there don’t population, types. safety, number the evaluate So, we broad at of tumor the and

that all emerging patients Phase absolutely, a cohort, selection information and some tumor However, other the of X the data must the express The of study, as to have all Tom’s portion that the guide does group expansion FAP. we other gathered tumor will well cohorts use points science. the literature as has from available

of will unmet and features we a as limited scientific we success into tumor will need and market account. and probability X, in types size as well of number based So, have pick potential tumors taking Phase on

Paul Choi

dose clarify And lucitanib? include would regard tumor could cohorts a or maybe expansion presentation maybe type sort on as that initially had both I a question regarding data to XXXX you’re follow-up or just year, follow-up right working And now? that you then, just of next with for escalation potential the the population

Dr. Lindsey Rolfe

end So, although, noted expect we present next of time by start most Phase in conference, submission, data XXXX. cetera, X off call, et publications, would of the of we expect as to lead I given LuMIERE, X, to the the do be that we in part the based Phase year for enrolling

Paul Choi

here. then, would will is populations you endometrial indicated for much. XXXX? that be you evaluating there Thank But, still the Thank cohorts LIO-X very guess, And Okay. that lucitanib, you’re I just year-end something you on to that. a present quickly in that expect potentially or by you view

Dr. Lindsey Rolfe

in year for conferences, move the I based [indiscernible] than this and think just early in LIO presentation it be I think. Paul, data from these rather Okay. will on XXXX, endometrial

Operator

over I We for in like the have closing turn queue. Sussman no back further call remarks. to Anna to would questions

Anna Sussman

We everyone Clovis today. interest Thank Great. in you. thank your for

our at day. Thank days. any If accessed this questions, contact time replay be interest via hour. webcast good an at Breanna XXX-XXX-XXXX. you can a me clovisoncology.com, we and or This beginning for appreciate have of you, be XX a in Burkart morning. and It XXX-XXX-XXXX call at your will follow-up please available Again, about have

Operator

you today’s conference call. This Thank concludes your for participation.

You now disconnect. may

Clovis Oncology (CLVSQ) 3 Nov 212021 Q3 Earnings call transcript