CLVS - Earnings call transcript Q2 2022

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Operator

Good morning. My name is Samantha, and I will be your conference operator today. At this time, I would like to welcome everyone to the Clovis Oncology Second Quarter 2022 Operating Results Conference Call. Today's conference is being recorded. [Operator Instructions]. you. Thank like Investor call Anna Relations now Vice to Sussman. turn of President and to would over the your I Corporate Communications,

You conference. your may begin

Anna Sussman

Thanks, us. Clovis to Conference everyone. We Samantha. Quarter Call. joining Second XXXX the you appreciate Good morning, Oncology Welcome

this release. And seen on it's if news clovisoncology.com. at website morning's likely not, available You've our

for and the As Remarks following: Patrick the ASCO data quarter Dr. President and live Chief archives Patrick also Medical updates will additional regulatory accessed and for Lindsey clinical cover Financial available summary the for then data time results Lindsey Mahaffy, which filings. website Q&A, for during plans and ATHENA-MONO our next may our quarter. call as will in SNMMI recently Rolfe, upcoming recent will this CEO, at the will remarks, Muehl, will Rubraca we'll questions. our Officer, the the for provide Then then closing anticipated Dan milestones during on will and call make available a being the is Today's call Dan the discuss provide a and conference Pat, reminder, FAP-XXXX weeks. of be well the to and a as second Officer, regulatory then recorded answer webcast. highlights; financial be will Chief be and few agenda the and open Rubraca. FAP-XXXX and presented Lindsey at several our our includes

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

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

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

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

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

Patrick Mahaffy

everybody. Welcome, today. morning. your We Good Anna. Thanks, time appreciate

the the clinical key and safety candidate, that. the We data clinical and first in therapy Molecular demonstrate of Conference, the from of Medicine at data protein, that detail multiple initial promising encouraged types Lindsey, or Officer, with of presenting a Medical and greater types but obviously fibroblast FAP, in forward is year. will results solid cohorts additional and peptide-targeted FAP-XXXX. clinical milestone evidence first tumors. by Phase to The which the theranostic our data, first expansion look a the second Sorry LuMIERE data activation target discuss Nuclear achieved are Society and in Imaging showed many preview further Annual for the about a radionuclide trial later presented of expression we II quarter importantly, activity shortly, our with of this were initiating across Chief tumor

reduction and has of to diagnoses as year-over-year than XXXX. XXXX COVID prior The the in to lower cancer ovarian fewer compared Turning patient in starts result U.S. in $XX.X X% QX in and second-line a Rubraca. maintenance treatment. continued QX impact to Sales million, previous lower quarter the were quarters XX%

of treatments for quarters. increase wholly second-line this not ovarian observed indication levels, While to several to reverting front-line almost cancer on the likely be pre-pandemic doses will effect and appear impact is the

Phase FDA Rubraca's the III PARP inhibitors the clinical with were the at use opportunity address ASCO at The and ASCO inhibitors of in Annual we Meeting the presented positive where prostate and the ATHENA-MONO in both also earlier addition, that in to settings. applications feedback positive quarter year. during this meeting results population from submit ongoing provided to cancer therapy approval believe results. to studies. we interact ovarian lines decline based prestigious in regulatory is series. reported later-line on ASCO of recent both confident the Best for we impacting adoption of larger ATHENA-MONO and patient of recently sales, overwhelmingly us community, the III this for PARP We remain potential this Phase setting the to In intend on in the received Despite and indication front-line in the our EMA

data this cancer Following maintenance additional setting few fourth III year. in the in Phase readouts top first combination next in two second-line trial the Rubraca is in quarter from with expected prostate the line quarters. front-line TRITONX treatment XXXX. for is Data early the Data are ovarian the the quarter setting, from expected cancer treatment in trial with Opdivo of Rubraca, the expected ATHENA-COMBO in ATHENA-MONO,

Lindsey, to call balance the reiterate over efforts to want turn to I sheet. I also our our Before improve

our that resolutions we stock the a shares the a were potential solid reverse While in that achieve not related split to we threshold shares did proposals. favor pass, to were voted majority disappointed and of were authorized grateful of

for strategies are alternatives raises. flexibility We to allow currently equity future for and exploring

licensing with royalties. additional development FAP-XXXX an support related upfront Lindsey. turn to capital Our the over milestones, to raise discussions and preliminary also rights currently with I'll include are efforts and payment entering to partnering and in for call the into And for that, development strategic to arrangements, and we commercialization certain potential partnerships research or

Lindsey Rolfe

start in morning. and FAP-XXXX at for highlight expected of were Good key Thanks, for clinical summary that data a presented SNMMI milestones I'll the with the term. Pat. clinical near the FAP-XXXX

our and used in both targeted reminder, study, an candidate agent enter the theranostic. program. protein, is radiotherapy activation clinical targeting is FAP-XXXX FAP-XXXX development and the FAP, the agent I/II is imaging As known or therapeutic peptide-targeted Phase first as -- agent therapy a fibroblast and LuMIERE a program In often quick radionuclide as imaging lead to a development ongoing

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

a that in dose gigabecquerels activity. lutetium X.X partial recommended FAP-XXXX. generally X of II agent, damage of For causes and profile of in in a four in pretreated therapeutic will FAP-XXXX cancer or the X.X dose moderate among is confirmed The third data the the Overall, gigabecquerels the per lowest labeled planned of in ionizing and agents schedule mild were radiation of manageable the lutetium-XXX cell with X.XX attached first included and safety the found study of the patients adverse events that administrations investigational demonstrated death. Phase dose safety RECIST The at cohort ongoing response The lutetium-XXX, presented Treatment-emergent patients safety of SNMMI of cohorts. dose evidence completed and FAP-XXXX. activity allowed who X a XXX identify heavily dose is DNA particle emitter early evidence the to appendix I population treated to X targeting the of FAP-XXXX. cohorts patient be beta an ongoing. isotope of LuMIERE Enrollment evaluating FAP-XXXX maximum of the therapeutic the the included FAP X the Phase is received portion to

types. identify gallium-XX for FAP-XXXX a is at with of were imaging imaging agent tumor LuMIERE, labeled II suggested updated is cancer addition patients Hope, Phase from metastatic with promising initiation tool In the study. being Congress patients cancer at is additional I separate the LuMIERE presented led Dr. Thomas with from which EANM the presentation are of FAP-XXXX types this principal in also Dr. solid across in to study, SNMMI. to a by investigator at anticipated Presentation Hope's FAP-XXXX of fourth XX and expansion that investigator-sponsored quarter both XXXX. imaging study a in Phase Annual gallium FAP-XXXX currently UCSF, multiple cohorts PET study, tumors. data and as also range of In of ASCO underway novel studied the data data is is who a the LuMIERE This being

advanced independent in positioned Rubraca the alone we switching we to Phase is Rubraca. newly placebo study evaluate III the ATHENA, setting ATHENA in cancer maintenance of well terms maintenance advantage potential Rubraca of front-line uniquely With believe and in diagnosed ovarian front-line, Now are front-line to a monotherapy X,XXX-patient any two as over the in outcomes: combination same as Opdivo versus setting. of maintenance. Rubraca

all and brief subgroups As investigator consistent mutant U.S. ATHENA-MONO or wild-type primary randomized populations whose the labels. of observed those The the or detailed review seen Rubraca today. BRCA safety call, patients both just current exploratory a the ATHENA-MONO with HRD-negative BRCA type/loss LOH for those versus of assessment Rubraca or Rubraca and is HRD-positive trial, also analysis: improved efficacy in met of with PFS, in was its progression-free be both heterozygosity, high PFS tumors a could wild BRCA monotherapy status survival, tumors: ITT. with in provide A ATHENA-MONO benefit evaluating determined. placebo disease either primary not population and LOH, The versus or monotherapy the with endpoint, within which previous the in we showing HRD-positive placebo, I'll by in on results patients European was

to to and the submit to variation II indication, For third an the we intend quarter. sNDA FDA Type front-line a during EMA

other mature the sNDA. overall encouraging FDA And survival to Drugs the when the front-line that of overall it support study, data more recommended grateful believe results, as that disclosed, use Advisory has the previously have survival overall familiar FDA mature results. the more ODAC survival in of community FDA application. be to we of of an consider trials need also receiving from ATHENA-MONO is has approval the sNDA will and reviewing discussed has indicated If the the the Committee Oncologic that endpoint submit with are setting. an rucaparib for an clinical known may strongly meeting. at the We for we supportive clinical the the sNDA ATHENA-MONO from wait primary data PFS submitted prior we're indicated to As data,

cancer ATHENA-COMBO, Phase Rubraca, Opdivo from data Looking patients. cancer, Rubraca Rubraca the to quarter the versus potential population III ahead XXXX. for to of of introduce front-line Rubraca study only ovarian broad first treatment represents are a ovarian for ATHENA-COMBO to other of monotherapy, for anti-PD-X-containing plus in an of combination time opportunity the the first monotherapy expected the maintenance The readouts regimen in

early provide trial mutations. the fourth prostate is Rubraca's addition, versus androgen therapy patients the current of protocol-specified is III TRITONX with the as potential castrate-resistant Phase to in chemotherapy data patient are the from castrate-resistant second-line with physician's BRCA readout line approval a timing trial and contingent metastatic XXXX. expansion. ATM therapy or in of second-line for Rubraca of both and for a reach cancer This study study the evaluating each larger for In potential lines prostate deprivation the progression-free earlier ATHENA-COMBO in opportunity top cancer or for TRITONX confirmatory occurrence The an quarter of well expected TRITONX in choice upon events. data label cancers. survival ATHENA populations ovarian is prostate as

Now discuss I'll to turn the results. call to financial quarter second over Dan

Daniel Muehl

and XX% $XX.X hello, from a Rubraca net million X% Lindsey, product million QX a XXXX, for product and QX decrease on U.S. We revenues ex revenues million of distribution high of product for everyone. sequential Thanks, and QX million, revenues represents reported XX% mix XXXX -- XX.X% quarter-to-quarter, in product revenues but of totaled the year-over-year million, to U.S. $X.X $XX.X QX respectively. and and with U.S. QX net fluctuates of ex XXXX revenues metric million. $X.X compared This of of essentially included Europe. level U.S. the Gross-to-net flat product decrease $XX.X X% U.S. revenue included $XX.X seems XXXX, XXXX. net which depending in reported globally This adjustments and revenues likely the for XX.X% product which

$X.X revenues million as $XX.X comparable on period spending general due Selling, increased million for X% correspondingly. for in primarily reduction totaled proportion QX $X.XX the XXXX Included comparable global U.S., to share. loss million million per the to share administrative period expense lower QX in compared We adjustment compared XXXX of As $XX.X in the of QX for million for clinical down of due previously the net no for will in to QX expenses for in efforts. $XX.X gross-to-net Research million other inventory. net or in XXXX costs loss totaled European and were compared XXXX, to included XXXX, increase in for compared of and XXXX to overall $XX.X $XX.X development compensation costs XX% a million to QX XXXX reported cost of the expected comparable results trials. expiration Rubraca expenses XXXX QX million is a to loss share-based such currently to noncash $X.XX discussed, down $XX.X Net There million XXXX. Rubraca period in a related XXXX. per manufacturing or onetime $X.X $X.X for

to a in of XXXX. as million of $XX.X Clovis had cash now debt. Turning equivalents discussion cash cash and June and XX,

as As on to and June financing to Street company continue estimates our the our LLC, had expenses Rubraca, XXXX. generated XXXX, available ATHENA under for raise going under and revenues current million the company near trial beyond in $XXX.X of Partners, up plan of capital of together the XX, order equivalents the operating clinical with under drawn cash, cash clinical ATHENA additional the ATHENA in Sixth a current and liquidity February had available fund to the agreement to agreement, need will million trial. concern financing Based fund the SSP, to by the term draw $X.X

had As overall of approximately total were of number reverse number sufficient a split. of reverse at proposed of which the in unissued to voted a company stock, clear stock split to reminder, favor shares have majority, The Clovis Stockholders increasing common common stock not the shares the of shares the the issue. we stock meeting Annual the authorized, effect unreserved and voted the who Meeting of approve of would XX%, XXXX for have at available of was the

would has stock for do to exploring and Therefore, to offerings. to able or permit in approval available proposals of flexibility or in support of sale we increase alternatives raising super-voting support. shareholders we that meaningful not capital equity raise shares currently equity-based additional by be -- peers through to As stockholders similar been indicate existing already shares that public to have preferred a common issuance capital be of number stock mirorred utilized shares offer transactions, through of the sufficient result, where the private and the are available situations greater currently favorable strategies votes such of including

Clovis of products XXXX. plan a entering Pat transactions, one actively or reported in strategic licensing need to XXXX, cash XX% in expect for funding alternatives product and is from $XX.X concern complete to burn successfully $XX.X in from continue more exploring down strategic sufficient raise financing fund and down candidates, XX% XX% beyond equity other company's used mentioned, partnerships QX that capital into our XXXX. sources in financing. Cash would combination order As including than going would also activities and agreements or of equity through was as $XX.X operating in QX Net to million, or of we some QX was QX million the of February $XX.X operating down million QX million in We million XXXX XXXX. for from $XX.X XXXX

turn to I'll Now call the Pat. back

Patrick Mahaffy

based to potential supportive, in in look submitting forward leader date clinical of initiating Barcelona larger FAP-XXXX, from earlier and the of data LuMIERE the and fourth therapy expansion and multiple to look in safety presenting and to Thanks, Thought confident the to variation updated been address We seen forward Dan. data clinical In NDA has populations Rubraca's types on LuMIERE in study the from during data the for and we but prostate ATHENA-MONO third II encouraging lines quarter. enthusiastic in ATHENA-MONO cancer. II with we October during remain both and Type early activity cohorts feedback patient on summary, Phase ovarian the tumor quarter. the the trial

XXXX. early in ovarian data in We in that, this ATHENA-COMBO maintenance readout answer TRITONX prostate cancer and of setting treatment fourth first Phase the with front-line Opdivo year second-line continue the the quarter anticipated you III happy any of to be combination in we'd to the in look forward to with setting the treatment cancer have. questions And quarter

Anna Sussman

for all we case, In Thanks, Oncology That's thank unusual. Clovis in Okay. that interest Samantha. you today. your

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

Operator

today's conference concludes call. This

now You may disconnect.

Clovis Oncology (CLVSQ) 8 Aug 222022 Q2 Earnings call transcript