NVCR - Earnings call 3 2023 | NovoCure Limited

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Operator

Welcome to the NovoCure Q3 2023 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Ingrid Goldberg. Please go ahead.

Ingrid Goldberg

Good morning, and thank you for joining us to review NovoCure's third quarter 2023 performance. I'm on the phone this morning with our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; and our CFO, Ashley Cordova. executive for are Q&A. our call on of available and members leadership also team the Other

our under For release on on can reference, be Relations your slides found our accompanying website, Reports. Quarterly this earnings Investor page www.novocure.com,

and our with our in non-GAAP business. Reconciliations financial earnings control of update our a slides attributable involve the rate remind compensation. We GAAP from as to and those forward-looking are Before is items reflects beyond adjusted financial EBITDA measures share-based Form appropriate, measure discussions that described are statements. and do taxes, in evaluate projected which financial Relations time the page and also Investor by the non-GAAP include statements, Where in during except to time and EBITDA, adjusted like are our could value These earnings release, filings. We uncertainties, we X-K results website. our to SEC statements will our not of and call included and metric filed these statement, to removes specifically of you actual will materials we required depreciation, a conference law. differ would structure, in amortization risks today. publicly thus tax believe our the our start, it forward-looking I by capital intend impact refer to some any important for an press noncash business, interest, number generated as accessed to to of SEC measures earnings can this of materially in be our of These from

turn questions. I over open for your we the Chairman, our prepared the Executive our will remarks today, Doyle. Bill will call Following to line now

William Doyle

is you, Fields. therapy cancer and NovoCure, of aggressive the of morning. the most Ingrid, mission through extend novel Tumor forms our Treating of good in to survival development some At Thank our

our of in made numerous we on progress mission. This fronts pursuit quarter,

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to back thoughts Our clinical quarterly therapy events. Shifting results. with data global of on are of by of was supporting the X,XXX with across added patients execution devastating to finished a cancer QX and body affected therapy at NovoCure. these active prayers the everyone the continued We indications. use period period significantly and our multiple TTFields

made program. our our also meaningful progress cancer clinical development update next trials, This of morning, an series our and including lung we pipeline, will We product with begin on of enhancements.

clinical other our business. discuss then and will We our programs commercial

cancer were a close third data will clinical of especially financials. In program. of cell clinical supporting published In in continued the our with therapy metastatic the the LUNAR We Oncology. lung QX, the the non-small results of Lancet in August, thoracic of quarter we foundation review to Phase TTFields trial journal, use in III strengthen

journals. XX.X immune treated with of LUNAR As for who standard patients oncology median checkpoint Lancet an premier data were months The immune in patients received months extension care to therapy alone. one XX.X months demonstrating inhibitor showed X.X patients compared TTFields therapy alone. an with in pronounced and Oncology TTFields clinical the patients XX.X survival more checkpoint is for compared results to a statistically with significant overall inhibitor, the research of care, overall and in reminder, and survival clinically of meaningful treated exhibiting treated survival median standard a the overall months

LUNAR proud platform. prestigious and the have impactful data in We this to published are

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and Phase evaluating trials of treat III therapy from nearing line Beyond program, major half PANOVA-X the And METIS for the XXXX, line cancer top trial which now the of enrolled therapy made for the and expect TTFields TTFields expected open trial, first-line is of XXXX. TTFields PANOVA-X Radiosurgery. is data progress of cancer. In its first locally of thoracic X Top is to for we evaluating is and atezolizumab in brain we recruiting milestones. the we use pancreatic lung our of actively the PANOVA-X QX randomized cancer. in treatment is late also the therapy METIS PANOVA-X gemcitabine cell study, stereotactic non-small clinical together together patients. with with our data have patient the second metastases QX, in treatment advanced exploring metastatic following from use use nab-paclitaxel pancreatic

to our future cancer multiple in reinforces INNOVATE-X quarter, non-small understanding we the we suffering we gained and in years. I trend my cancers therapy. its enthusiasm those reached line future with GBM learnings trial launch have benefit of And in in those milestones Asaf failing opportunity in are trial readouts plans third for today for near used INNOVATE-X by treat future their platinum-resistant ovarian close of the the coming and a that the the is come therapy saw survival platinum lung that And results for from disappointed look our single when to TTFields forward top for to cancer NovoCure. most the difficult-to-treat earlier journey in cell more like Platinum-resistant our we condition. docket line many year XXXX, who therapy key the line to the it's of entered therapy notably, design trials. Most our enrolled in for future. Phase With the a failing did after cancer the and turn women results patients INNOVATE-X, for The the enrolled who previous reiterating in informs discuss is business. ovarian not III while from bright patients this lines to early now trial the will on for observed meet promising endpoint. top after a difficult-to-treat compared announced we of cancer. effective trials. I'd INNOVATE-X on X Finally, we have to to primary is

Asaf Danziger

Bill. you, Thank

core GBM the invested on record ended flow revenue a cash TTFields third patients that business are the therapy. of free financial with and our the in generating is Our strength, billion $X.X X,XXX platform. We driver in quarter active

XXX in French launch more have a therapy. successful than have very We patients and France on had Optune

among success. In launch. efficient future patient commercial and to addressing investment, country We emerge levers starts, new including the a the have duration the French building launch have serve continue blueprint for patient alignment Early effective and awareness therapy our focused the through for years planted synchronized the learned will patient we an leaders. We loan care many we Teams are on U.S., dialogues prior in French reorganization. and activities and playbook built following and French therapy cross-functional X the TTFields as our our and lessons in growth, believe seeds usage. improved our see over to team health rollout, therapy key contributing of

net these critical in inputs revenue. of growth long-term patients and All are active to

I increasing the the We prescribing messaging QX, following among strengthen focused Our our finalized Power potential patients believe to of introduce TTFields direct-to-patient teams demand campaign year. therapy the and will on are expect diagnosis. physicians. In from campaign, benefits Life, patients market and awareness TTFields the next we direct-to-consumer and of awareness to My raise of

expect demand will direct-to-consumer patients and from We greater to engagement driving instrumental be caregivers.

TMZ especially on our of of torso. this the has We community cancers engagement X is data with using oncology patients Ballo to the patients, GBM congresses, added TTFields and evidence for confirmed GBM Dr. surgery. clinical X,XXX the Physician TTFields analysis confirmed EF-XX recent was of outcomes ASTRO of III to our outcome studies Ballo's associated after key trial comparing the therapy Phase Matthew July, during treatment are of improved where foundation real-world GBM also the for the survival outcomes therapy reported the an as and the benefit the of published strong in size a when driving patients time. Real-world more physicians. been therapy penetration meta-analysis markets. In focused important earlier XX% prescribed tool awareness among reinforced broader and reach this to over greater and during of analysis driving current is look Strengthening month. over achieved TTFields Dr. we in of

improve duration of drive Beyond our are arrays our we of therapy through we generation This drive efforts working month, next and ease launched to demand, in development. use Germany. to product

the site As materials leverage are new without unique these to in and increase previous and corresponding intensity they patient experience, thinner hit. reminder, greater to lighter, the arrays a deliver have tumor the improve flexible than versions, and ability a a design more to

to are later PMA a for track arrays supplement the to this new We the FDA year. on submit

who of the will our Additionally, pleased Chief new we Officer, join hiring us Medical in are announce January. to

from and close restricted to candidate's fresh pleased will leadership to full and team. Pritesh While we Shah this also look from his very the stay to new our at as a like adviser to plans several violent adding It time, on members family emotional would NovoCure, served lost and sisters, are today's forward and to atrocities of to now we mothers weeks. CMO for by difficult hope war turn all at perspectives and are loved I transitioning is to friends The and will carnage. that our the makes us expertise in close continued including is NovoCure myself, details Pritesh be to impact conflict in are sharing Many us, pray have and resolved transition reality brothers the teams. I success Israel. events said me ones of this daughters, the that few the and be of last horrible, sons fathers. will who of harm's this call. now way, it describe swiftly. I Ashley our to to addressing the ensure the an quarters smooth have today. of And

Ashley Cordova

Asaf. Thank you,

third launches several With essential the of revenues prepared we multiple same are and verticals. The coming the X% third ended on regulatory opportunities consistent increase in commercial an growth $XXX X,XXX net September quarter from on million filings active to the in of was and execution last a to investing leverage the with therapy, years. We in generated patients clinical horizon, in across readouts, are fully the year. period ensure period infrastructure we quarter

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shared, in be our the near the term. This market. enhancements, out such acutely have quarter. product arrays will roll our impact with as as new development As quarters we impact Germany arrays will our we more in coming the margin in gross new largest this felt beginning

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in cell investing are in We lung to market quick capabilities capture continue activities the growth non-small to includes commercial future. pre-commercial to we This cancer to tactically penetration GBM, opportunities to invest access and ensure reach in increase population. in capabilities new patient

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the a launches new in population. are the with larger of in and of We commercial horizon window treating investment preparation, much potential patient on

these With near-term opportunities long-term to vision. allocation are to approaching, we investing align committed our capital growth priorities strategic tactically with our

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was soon and highlighted XXXX we GBM Jovan last thereafter. with As you may using began diagnosed recall, Jovan Optune October. in

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Operator

first Leerink Our question of Chang from [Operator comes Instructions] Jonathan Partners.

Jonathan Chang

your for about behind year? Fields? Treating lines before What's study the PANOVA-X Tumor strategy be you study the PANOVA-X thinking we that? Can with associated PANOVA-X And the time pancreatic should the the discuss next how initiating cancer rationale and readout

William Doyle

Jonathan, details to this failures, the over is many, course. diagnosis of to describe is it turn with cancer of to has Bill. pancreatic the many cancer one difficult and I'll of of one But most of start difficult and course, PANOVA-X. proven Uri then to most treat be the

Our fact therapy. depend region can on strategy differentiation starts know of the region get the chemotherapies to because we with of through pressures. tissue and Treating the the Tumor circulatory the that fields the that even of issues can't system with deliver Many we that stromal

trial, is remind on locally can first for on cancer extremely we completely pancreatic is that -- pancreatic sample there. Further, showed start disease locally with trial advanced a year. therapy. we and impressive stage Tumor of toward we Phase to successful Fields advanced Treating small a results and So the I'll II out very our cancer. read PANOVA focused disease this size, start PANOVA a the encompass trial, metastatic pancreatic expect also our everyone, a end the and is we have this first-line trial. where extended built And of we in next both the We where the cancer. In

at gemcitabine we So start and the diagnosis combination time with in nab-paclitaxel. of

And in patient preparing terms of about of we're so we And rolling the enthusiastic optimistic this remain the therapy design here trial. very for population. success this out and to

in Uri, the pardon results, describe So the over to or it let the not of me that's turn pancreatic locally strategy. And describe our the intent population to to but expand once we to results cancer anchor me, advanced. element first now patient to

Uri Weinberg

opening the we're study for background program the the study our our integrate learning is from So GBM at to from learned program. results X-THE-TOP through clinical lessons and our patients, that checkpoint immune best in where should the time off the doing PANOVA-X study. results PANOVA-X of diagnosed this reading in scientific of and the performance we LUNAR we newly also concomitantly that And seen have next inhibitors. cancer, when with prior TTFields step even We outstanding used hold not to feel an on pancreatic

So with It will for atezolizumab and TTFields is metastatic done in anti-PD-LX and incorporate PANOVA-X with Roche disease. and these will for reasons. be concomitant chemotherapy collaboration

Operator

comes [Operator Wells And Huang comes Sandler. Bednar Fargo. Piper And Jason next our of question Instructions] of our from question Lei from next

Lei Huang

Larry. Lei Can hear for It's you in calling me okay?

Asaf Danziger

We can. Thanks, Lei.

Lei Huang

comment Just there Is a trial on date completion I KEYNOTE-BXX any mid-XXXX. -- you on on starting for is clinicaltrials.gov, side. update lung on a there few questions, have that? Can the the

Pritesh Shah

the Pritesh. that's the pilot first-line cell use for a BXX study that Yes. that's a Fields with non-small of KEYTRUDA. Lei study the this is study you cancer Phase open, very II lung question. Tumor in We're excited Treating to exploring Thank have trial is

So that us setting. understand it's up in benefits will the the moving first-line IO Fields an study plus Treating Tumor of an help important

is trial the open enrolling. So and

already space that that competitive lots the One that trials and agents need. of this perspective, open of cancer space. trial There are of it's lung lots of of from aspects are high in a are there unmet very the we a because know,

study So can II to rapid a enrollment get for like challenge. be a Phase this

all make because again, the study first-line will support Our and the continues understand, we Fields Tumor this teams Treating enroll the important be are that us to it focused role setting. do to help to on ensuring work sure that of the in education

Lei Huang

time that on update accurate? mid-XXXX an Is that clinicaltrials.gov, is Okay. there date Is line? the on

Pritesh Shah

are of say like that's with a because pace an all I on So point. anchor would just studies they enrollment,

enrollment to front. study the end As an will sort updates continue date, that provide gets we of on to closer

Lei Huang

and your Got to Okay. any LUNAR of patient new the development? to is it. line KEYNOTE-BXX there related time line trials to bridge to way help And first in that, expedite enrollment

Pritesh Shah

Yes.

interesting So that's question. an

any up of moment, ahead to that can wonderful speed an getting it's operational There BXX LUNAR-X think we in we enrollment, I was the those going study, start protocol to so take opportunities. really different now X enrollment can is setting, advantage LUNAR-X. which be are in at the time of protocols the

the give different this a So similar quicker read study us population, albeit they're of patient X meant is to protocols.

look are enrolls So advantages any study it as efforts. our accelerate we there to see will LUNAR-X at the and if

Lei Huang

questions Okay. And QX on few a the then results. just

really Germany. On impact prescription actually was just reps just were Or I as was to of we forward? And do And about launch? think expand you on Can aspects strong, volume the world you about on on volume the rest France of high-quality that focusing it? other call, think prescription talked volume how well. in there patient And prescriptions the that? going

Ashley Cordova

this Thanks is Lei, the question. Yes. for Ashley.

is Germany. patients it have in on focus would you that So we

reflect on is our physician X% active is, now What side, coverage criteria that the really the were also So you patients fully that does but can side. up both new on year-over-year. see understood

not over are course not that that nor paid. were scripts which so have And they getting for reimbursed. stopped of year were XXXX, we've filled seen scripts writing get is will Those that physicians last what the scripts we patients were for

everybody messages kind and and maturation that in understood are we'll that's get these for. of now market understands So natural a what paid positive

the as is well. right in market. And right trending as you well there and that that's really rest world noted, So patient I anchor, at look active would growth, that of

we active there. mentioned, a a say would patients more world then the and XXX saw France, we as of around rest the than stable So with patients out in business really strong I in performance

Lei Huang

just can Got one it. then squeeze in more. I And if

due November a XXXX. that's in have convert You Zero

But has we optionality that's have to I How redeem about this think at the presumably, conversion the point. maturity? happen to option at company year. -- point do or going redemption think before some this not the you the

Ashley Cordova

it's is another an recently. have lot question reiterate I -- are you mentioned we the can and asked what script one What that incredibly balance No, will strong we I a Yes. getting as sheet. great that imagine, say in

have a $XXX billion which generates off We about GBM flow. in business, revenue in $X.X and free cash million throws

are an We R&D organization.

are sheet which to we to these investments how us on at a that kind to our get are strong successful our committed long-term So pipeline our hand. astutely but know we of growth, balance in through and us very investing future goals creation, while opportunities the short-term eyes and looking we through and future we in the get launches, have keep can is product both manage we we that value ensure ensuring

say our much I assured, control focused our is what are is say something and ensure throughout in I being on metrics --to So the very that flow are will very free cash are that strengths journey. we actively would rest P&L the just maintain this and and we managed,

Lei Huang

Okay.

redemption or this optionality on point? no So at comment conversion the

Ashley Cordova

Correct.

Operator

question of next our Emily And comes Bodnar Wainwright. H.C. from

Emily Bodnar

What that much for is maybe why thinking you in from -- to readout. capabilities? benefits there? getting didn't get curious successful, still your the PANOVA-X of kind in GBM you you're kind first METIS how paclitaxel are starting the market launch INNOVATE-X, And opportunity on given X used as the show PANOVA-X the a it's backbone, given closer with and second as INNOVATE-X to paclitaxel question, also survival overlap follow-up may of and which then have being really are the you're Maybe thoughts and question. I'm differences benefit. And terms just of think discuss in with commercial your me using about that any combination you confident

William Doyle

Sure.

the very So thank much you question. for

let differences study. and comment between on study the INNOVATE-X the me the So PANOVA-X

entered showed we And patient benefit had that of women therapy. described therapy, X recruited script study line in communications, to after show failed of prior X therapy. X unable of women lines when prior failing up consisted of population study was and had a were failed As other into after but INNOVATE the the we benefit lines the and many prior we a they X, to the who

very cancer -- directly It's shouldn't where So disease this again treat the also that and the region I with and to the Tumor these first have were the a have stage the this that a in III population. fact, have spread Treating now fields. I say studies brittle women in but able I PANOVA-X, line. of again Phase in these very failed, beyond earlier, -- sick, particular failed women has the is as we're with study electric contrast Fields said failed

not So this body. -- have has spread advanced, the have patients a that fully who they diagnosis. is locally throughout It's study disease after in meaning that not the

So we disease. can treat the full extent of the

of can treat platinum LUNAR, metastatic where with in saw systemic combined journey, we we Phase the lung disease, that who combine Uri early leads benefit. And immunotherapy. So then know benefit saw effect case, PANOVA-X we the an in a inhibitor. alone death, create Tumor our the in saw we benefit effect immunogenic that to was, journey. And our the pancreatic where the I II -- checkpoint the to you benefit of benefit antimitotic the Fields and with immune that just not of in when results end were ovarian really saw cancer what would anchor after, we when we great we an in on in we with is Treating again is in patients derive that after these cancer X were Phase facts when And immune treating therapy. greater This to saw comparing will cell And described, we we The that tremendous Phase our inhibitor. our II. the fact, get compared we where II turbocharge with in of women checkpoint then ovarian the failing that at their ability

to So that get with Fields we But in we immune for a checkpoint inhibitor. to treat a the lot maximum to And the to treat discussion. disease later until of have really Treating need in in benefit want wait journey, progression was early patients. with disease an order we Tumor plus chemotherapy, if

Emily Bodnar

And METIS on the readout?

William Doyle

the on market. So METIS

think will I same again, So infrastructure. commercial we that advantage, we an do be in using the have

who are So the treat metastasized non-small brain. glioblastoma, cancer even though oncologists it's the disease, has cell the clinicians. same a lung that different it's These same to

And leverage benefit place, us that the would same clearly we and that's expect commercial in indication. to will already when a we launch that infrastructure be so for

Operator

next Kumar comes [Operator question Bednar Vijay next of our of And Jason our And question Piper from Sandler. comes Evercore from Instructions] ISI.

Unknown Analyst

million you payments. $XX.X This called Noticed out is Kevin Vijay. denied that for

Just curious forward? And what were trends becoming be historically? change? there stringent? on payers denied payment helpful. this going Any color there any Is a this would means Are more

Ashley Cordova

Kevin, important is that because I Ashley. it really one. appreciate everybody yes, question understands this the this is

not our a of stringent This change. criteria. X in this coverage more we had is reflection is amount not quarters, in And prior fact, consistent that any over messaging with is this So a a I million million significant first you mean, here revenue quarter. number noted, the of X aged in claims And the as of of from months. our over tune from this in about $XX to in -- $XX claims year-to-date XXXX baseline the

expect for the in reflects our that our able collect revenue because is XXXX. and where the those volumes drivers revenue net position baseline on Optune which revenue patients. So our forward. a to We in and not is not that to base that are of it the we're now the be was in patient business. comparison current moving we would is actual year-over-year at

of fact, very coverage is elevated XXXX in and not is the more stringent criteria is this baseline a So clear, it more in than factor trend. an to be

Unknown Analyst

follow it Optune or focus about physician GBM to impact Do given perspectives its up, on METIS potential And or see your we as especially how trial you think from negative on if change the trial region. business the in those GBM same can your any I relates should positive on business? results

William Doyle

Kevin, another distinct Thank though no. important These diseases, by treated answer be they the Simple are is clinicians. may same even question. X you.

we've papers, and reports benefits, X stable, they evidence results established analysis their are is place experience. our the experience. In and Our now and real-world we in have own these numbers exactly the out the substantial commercial in GBM clinical recent And real-world meta of the we the fact, and practices. script, business of coming see particular, and Ballo's their all clinical well called extension survivals the clinicians have They where of -- prescribers evidence point in and in substantial separate They resounding at in the have original of also a world see patients. trial. same reached supporting in-office have

So think an plus be way. I to going effect minus, there's or either don't

Operator

turn to At closing I'd to Doyle for remarks. conference time, you. this Thank like Bill the back

William Doyle

year. your a providing support this and plan. much. METIS So progress, continued GBM are, in for I made our you to We've is preparing support world. And you future. and that's exciting are future, the messages excited NovoCure. The executing the where our we invest stable away in of financial interest to and I next us thank from imminent take clinical where program in first around business for PANOVA-X thank everyone foremost, call want prospects our in very want the and to are first foremost, we that to thoracic the by launch we're

stand be difficult this more We their It's that in time time a at time. Israeli country. we work colleagues, of busy So couldn't an NovoCure. our hard with it's during incredibly be and exciting to appreciative

thanks we next look to quarter. forward reporting and So again,

Operator

today's and concludes call. for This now you may conference participating, you Thank disconnect.

NovoCure Limited (NVCR) 26 Oct 232023 Q3 Earnings call transcript