NovoCure Limited (NVCR) 2 May 242024 Q1 Earnings call transcript

Good day, and thank you for standing by. Welcome to the NovoCure Q1 2024 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 in Ingrid Goldberg.

you performance. us thank first review and XXXX quarter morning, for to joining NovoCure's Good this by Ashley joined Asaf I'm morning Danziger; our Bill and CEO, Doyle; our CFO, Cordova. our Executive Chairman, leadership Other members will available for team of Q&A. be executive our

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

materially like will from and our discussions results conference statement, call include Before SEC statements. statements, We involve our that could law. projected These in we and time some by our measure share-based during a compensation. intend refer risks except Where those taxes, you time which differ appropriate, start, in from for these we forward-looking number adjusted control amortization to non-GAAP remind specifically do are beyond of evaluate described as I filings. to to and earnings financial measures interest, actual forward-looking would will of and required statements are this uncertainties, to our a not EBITDA, to business, any update publicly depreciation, of

structure, the adjusted accessed rate our items be GAAP to also filed our X-K Form important with our in EBITDA the is release, financial materials capital it material as website. the the page and can of non-GAAP and measures business. today. of slides are press financial reflects value believe included of Investor our earnings earnings generated SEC These Relations in from to and Reconciliations our metric best impact noncash attributable We removes an tax by

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

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

III I'm clinical ready metastasis with entered pleased our March, brain have cell endpoint, and and innovative delivery to clinical X commercial METIS XX,XXX benefits from completed lung treating trials, report last on Phase patients progression. our decades, we model. build today. significant the announced this TTFields treated therapy of intracranial built established XXXX technology, trial We and multiple we to developed mechanism foundation improved providing non-small over that studying met of its successful extension the TTFields an Over action, cancer Phase time In statistically TTFields the a in primary to III business progress

progression cell this announce PMA approvals incredibly of review will locally CE our milestones. prescribing patients post cancer expect with am platinum arrays will year, we work is year PMA of end colleagues supplement a today's for in trial an NovoCure TTFields approval our for of I call, lung for in for cancer. and hard business and many physicians. the our begin for FDA, our EU the advanced III and and mark exciting pancreatic metastatic with XXXX in data from we for commercial GBM. our Toward grateful Phase dedication we of XXXX, On FDA non-small Later therapy line the GBM. top next-generation

updates opening before from financial QX the we line discuss questions. of discussion then the trial a will our and We with close results clinical for will quarter,

our therapy. prescriptions records continued first of our finished and Both for at new with the QX global We organization. quarter X,XXX active we are X,XXX In NovoCure, steady pace on execution. patients

drive each on achieving patient critical persistence. input levers We believe, prescriptions, team all of we best outcomes in turn, believe compliance to Our sustainable growth starts global is commercial for including long-term is and patient focused the will patients and growth. active which

drive can outcomes. patient enhancements improved development product believe also We

filed our year, for was the with and countries, in European PMA our last reminder, As a new successfully December. arrays several arrays next-generation introduced supplement we the in FDA

leverage and flexible more experience. thinner, lighter, are to new improve materials patient the arrays new The

been on physicians. designs. focused and the improved Power awareness teams In New the launched campaign, we are benefits U.S. of in key Last patents month, Life. direct-to-consumer our the patients have among our potential prescribing increasing I a protect to of My markets filed TTFields therapy

first-ever patients print Through advertising and strengthen assets television, from raise will new campaign of our grow patients most direct-to-patient TTFields efforts messaging We reaches about diagnosis. we to the therapy and which Our digital demand caregivers Optune are following households, our and key GBM direct-to-consumer educating our television to business. believe Gio. are connected awareness U.S. potential and

As cancer. with objectives launch patients Optune one we XXXX and cell successfully approval of our key ahead, look lung non-small gain for Lua in is to

major Japanese mark We with have with have completed meeting discussions Pending LUNAR any including the for in approvals, in for FDA The clinical managers, milestone was XXX-day critical FDA, educators In are teams teams, and preparation. meeting our there experienced CE U.S. we the focused Outside decision the filing. that submission. PMA launch we PMA Germany, in U.S., and accepted and will regulatory formally territory [ trained awaiting PMA our our sales the Europe submissions recently ] a and regulators. was on the XXX-day productive, are a panel. and both hired regulatory patient teams. our are our substantive thoracic filed a referred no markets. January, to In indication We be

the Within the preparing organization, ahead. opportunities are for we

marketing thoracic field training and resources, developing certification assets, support internal training planning materials thoracic team bureaus, HCP are speakers, teams congresses preparing for teams. Our materials for assembling and future

the process to hit launched countries. prepared plan U.S. similar a in to and treat Germany GBM way treatment are We the We immediately patients we patient these using running. in following approval for to ground the named reimbursement

and share eager indication the the pass in clinical more months. support will another I to pipeline our Our now to patients large coming teams update. to hope regarding treat phone Asaf are to many more

primary clinical METIS endpoint, QX, trial. March, made latest start we marking indications. we X Phase In our III METIS. Phase in trial. Bill. with progress clinical strong will our you, main our I positive Thank advancing pipeline METIS In announced III

months at for to studied from METIS metastasis to median care arm TTFields XX.X month TTFields progression stereotactic supportive the The average the compared As toxicity. with intercranial function radiosurgery. therapy arm. with the statistically was brain Patients quality neurocognitive The of life ratio with without p-value in cell treatment time significant a experienced achieved XX.X X.XX. Patients sustained of were non-small cancer in increase TTFields systemic and results following X.XXX. lung therapy of therapy reminder, treated control in an a

of of meaningful mood are neurocognitive effects cognitive devastating involves non-small ability. year. decline results to and there Their Many rapid suffer The lung whole and prognosis metastasis. METIS brain cell brain caregivers. stereotactic radiotherapy, toxicity. mets typically which is thousands speech, risks only are from skills, poor major continuous with patients motor patients cancer or studies and brain is limited Today, physicians, very radiosurgery, life The innovation on risk as quality relapse and such neurocognitive of factors options in which treatment is each

population, increasing ] patient the offers to and the TTFields function adverse systemic major this sustain progression, intercranial neurocognitive For ability benefit. time delay repeat [ without to extend significantly events SOS need for

to interest Congress the clinical and like validating my relevance accepted June. will our a we Key of have that deadlines opinion be trial belief submitted METIS leaders METIS XXXX of METIS Monday, ASCO to Meeting METIS the as Chicago the and pleased presentation for accepted week, in Annual been the supported and in The the by the our the the after execution and planning patients has validated as trial. was I results. session third in and standard presented at investigators ASCO on thanks would late-breaking as express were our NovoCure announce to team enthusiasm involved study. long who in well the the Last

This announced platinum-resistant therapy XXXX. were with INNOVATE-X that best studies, TTFields cancer. selected Phase together ovarian paclitaxel our quarter, presentation the at oral results we INNOVATE-X III in trial also clinical ASCO as

and patients from pegylated Results TTFields analysis exploratory paclitaxel. or with naive PLD subgroup that doxorubicin an treated liposomal therapy showed

paclitaxel across months to So were treated XX PLD improvement XX.X the help naive subgroup, patients INNOVATE-X survival may of were in PLD previously one naive. who and therapy the naive potential was potential XXX dose. to doxorubicin survival receive line in the PLD to Overall effects a receive randomized enrolled in significant XXX the tissues of compared trial, benefit on clinical survival alone. Of in only TTFields on randomized PLD TTFields tumor patients compared exploring paclitaxel reported naive overall analysis similar patients total paclitaxel INNOVATE-X patients This cohorts. received the in alone. with patients In explain months prior to patients naive the therapy. and PLD is both to demographics baseline NovoCure consequences

understanding findings believe inform contribute We to our trial of of will a design. and these deeper future action mechanism

Keynote promising our and clinical Gio preclinical overall reports the the is The we Keynote this field of enrollment to completed lot of our DXX, TTFields XXXX. treated gratitude overall builds Phase TRIDENT I DXX trial when starting [ like patients and after approved from team. published pembrolizumab. survival to with Phase the within chemoradiation I chemoradiation look to reiterate trial extensive program, III X-top IND accomplished trial, future survival our with research studying compared GBM a a started data trial Optune ]. clinical and for my JCI quarter. milestone II Finally, We temozolomide our GBM on upon in forward FDA would studying to newly diagnosed the

performance. Ashley first will quarter now financial share details of our

Thank you, Asa.

rates Revenue cell activities first by clinical commercial driven readouts. XX%. X% and launch margin consistent anticipation therapy, active and regulatory year-over-year The generated in U.S. $XX ended Gross $XXX XX% We current the net in this first sales patients primarily in million on quarter The our and both by quarter important in and up in increase progress, successful potential modest was of improved sales France up launch a expenses and revenues million year-over-year. quarter, in were lung with launch quarter, period. SG&A driven approval cancer. of was the force the a and marketing and with quarter in preparation the marketing up increased was non-small year-over-year. XX% was expansion expenses period first XXXX X,XXX for growth execution for

R&D clinical partially The the were of our and decrease was quarter portfolio. XX% this driven trial expenses timing investments ongoing of down year-over-year. $XX within lower lower were personnel These personalities offset G&A. primarily for by million, activities by expenses within the

increase total of first in and loss The that health year. was Our increase million, November prioritize was and gross take excluding margin. growth profitability. flexibility We year-over-year. reduced Actions on focus to restructuring actions share-based intend million XXXX during future operational expenses, as efficiencies financial $X for $X NovoCure operating per by we adjusted driven $XX or compensation, maintain to heightened by driving quarter million revenue million, the taken increase negative was the the and quarter and growth a an $XX adjusted last share, EBITDA of and an compared associated EBITDA in $X.XX primarily first a for net position

million Pharmacon facility senior morning, Cash affiliates XXXX. $XXX investments of we and XX, totaled as secured have entered short-term into ] with new of $XXX [ credit March This that announced we for million. advisers up to X-year a

will used proceeds and maturity, today's full million June The fund XX, anticipated The are The launch XX-Q. tranche cell be was the X tranche second and $XXX NovoCure's XXXX. $XXX across for available pedal cancer. in XXXX. million An be outlined to at March standing deal will by of convertible NovoCure's first subject drawn the needs is notes to closing in to million issued terms discretion tranches working $XXX issued milestones upon non-small NovoCure's be to lung at and capital additional certain through

transaction, solidified us With a debt flexibility. this delayed exciting sheet position provides strengthened nondilutive horizon, with valuable on we milestones capital. with Importantly, the draw of facility our with sheet balance multi-tranche balance number further have and our this cash

importance with continue XXXX, building physicians Kelvin at considerable February enjoyed spending Doc and like Sinclair, of with collects for Optune decided composes hobbies. and on the research, appreciate time we we Gio his gym and growth Sacramento, and Doc numerous without the from was Optune objectives. children his he his And music, a users, diagnosed balancing raises coin Para body his X Optune discussions active profitability, right to helped after both close sacrifice by have glioblastoma. watchful our X both of him. highlighting is operates grandchildren. many Most Doc's having California. NovoCure, a I'd minerals, wife man Gio At of Doc an lifestyle was all, to In Gio with today of He eye and passion. home. achieving one has Doc and

It's we Doc remind patient's to what like do who survival aggressive glioblastoma. and we cancers do, people it us extend in what like why means

leaner finally, III CE in the at trial presentation slate regulatory and the supplement have new our from for arrays decisions metastasis for The Europe in submission of catalyst the cancer. mark We top line Phase approaching. pancreatic in an PMA ASCO, exciting PMA potential data U.S., the upcoming PANOVA-X and

and throughout to teams Our hand back heads execution, I'll on the to down look it forward for With are operator year. and the we focused that, updating questions. you

of [Operator Instructions]. from Jason And Piper our first Sandler. Bednar question comes

approval. share from FDA kind been Congrats I the an XXX-day mark to PMA submission? any CE non-small wanted is meeting the And good on sign. advisory today hoping first you the That face results start items other I you FDA is a your to to early on then get Are here or of hear the giving feedback cell. here team. with Good you know you'll any of don't panel. there related, think indication that committee can ahead on you've

question with my interactions, conversations body in the your on FDA with to to similar can just respect the anything Europe. discuss you regulatory So

meeting labeling will us was we productive the place. then and meeting, the that FDA. have think with we we'll the you continue meeting. as not and XXX believe a that mainly a XXX-day And expecting right we And the to interaction in mentioned, it I very review So puts be

our Regarding of we're with in regulator, half to the we discussion the by first its ]. which discussion it the year off [ get basically we continue European, the ongoing expecting

Okay.

major Script change be patient commercial what's possible for of CE good. leading but couple plans be and of indicator that's of no line here So The of is Or lot months. upside look international this today, other good I of don't in presence? launch well. markets. a seems you mark It your active clearly kind some you have as you launch France, to very here. should accelerating. where other time with a a year? other within in do That markets growth still some next hear going driving where we another the any to the updates the didn't see will currently European stand That's

very the Frank. France is size see revenues. are conducted first, just numbers, very size how to progress we opportunity This pleased and we can would Yes, in terms market the in we're the you with the France opened we're as up I Germany and in launch made the -- and be reiterate around that we've of seeing

-- updates line markets we we'll work more on that markets. We on along. -- additional specific become to kind We continue of can on pass milestones have sight those give of has we

So no look now, right continue direct do updates but to we for those opportunities. additional

for quick one one and other there Maybe right. follow-up All then one housekeeping Ashley.

with Frank, busy And that's year, guess, time to trying you're about? prioritizing. next apologies, you're Again, just again, this to Just sense you settle get that Is willing and coming I in if that lines is had full to help a it or maybe next markets haven't due that reports. here can debt? planning a share plan? the confirm chance markets the with us think paying it's But on want later the that when -- this terms. something you're And lot I which of then fully to rate really Ashley, I a to the year comes to any are convert then go debt morning the a cash through year. you're

I'll Jason, question So the again. Frank market answer first. this on is

But today. terms at I not looking Europe. markets, So markets time said going big of before, we've we're specific think we're provide again, lines -- I in to don't in the

milestones, working in multiple those along. get to and mix. are as we'll that pass areas, closer obviously Italy different So Spain And like we real both

just your Jason, I'll And on up housekeeping. do clean

morning our million become everybody, draw, of facility, X-year secured for of $XXX that ], is draw next million we to have we so June senior due far partners with anticipation our are $XXX the we facility cancer. be draw rate to settle have November lung notes million $XXX These did to plus which use terms The will are the full any million there. we [ to cash of signed facility And so convertible non-small And they I'll morning well. discretion. of convertible floating $XXX at our which thanks will Pharmacon. $XXX year proceeds does new this remind fund which committed are this in drew which XXXX. million announce of credit we We to we related we of fully and and a remove So working a cell in those believe is that there. sufficient It know this question notes. when needs the is capital overhang settlement the X.XX

our that eyes carry of kind looking through strategic sheet at will a ahead claims. now we're us So balance

Congrats again.

from And our Leerink Jonathan comes question Chang of Partners. next

questions. Two

METIS ASCO. of set expectations on getting First Can Congrats ASCO ahead you that presentation? at the study. breaker a on late help

Jonathan, this thank your is for Nicolas, you question. and

Phase As a amount III is of non-small cell trial cancer. metastasis comes you lung METIS with in know, brain huge it And data. a

So we you would The for top and will on results. initial rest, come the analysis X the because we're invite in working And weeks. to it. us see kindly show I still line

Got question study. it. second Maybe on a METIS the also

the you're endpoints, wrong help secondary today, in trending that you able the least direction. end while you On the of us out limited to appreciate possibility any in what can at points the I rule are are say

demonstrate direct really to we of again, But fields the excited ASCO. superiority far, so think that I show in you So are TV and to area.

Morgan from comes question Fye Chase. of next our JP Jessica And

in are you what This for that the on the III that indication? interesting the where for decided driven Is go study consider seeing And you study, that Phase indication? like in the pancreatic on the current for from to guys Jessica study opportunity it panelist study by Na it with you ahead another the another commercial sort it's indication. commercial have given then you've at seen decided for very of is expectation start and Sun to Question look second, have opportunity Fye. your -- you what when is peak That's in me. pancreatic the METIS mets, brain I think

actually, do the then , and update clarity within avoidance in some want have additional on METIS. the PANOVA-X to is trial I opportunity start the I'll commercial provide the with to pancreatic that the of [indiscernible] market we with delta this maybe it sizing Na, from data say had I'll ongoing. over to pass for always Frank

very our strategy. ongoing we're of that no the successful part excited That's and a part size our there. So there's METIS, With market update non-small just this develop enrolling of course But OPED committed to for have and as will of pipeline regards of is long-term and non-small approximately met some at very point brain ] [ opportunity. journey. one brain is to a a about cell XX% and the over disease their of a lung significant patients lung cancer cancer mets trial. diagnosis at patients of XX% cell

large on the is time population it patient So admittedly, the and a same both met. treatment therapies heterogeneous population. a focus also population very it the of who and as having at very is managing primary is to But systemic patient tumor a

we a treatment So estimate. in for systemic are mets. recommending precedent that a you therapy not take of There's conservative brain lot

few go we companies there are noted, this in As space. a that

model I patients for anchoring able think the and then to grow, are annually that your recommend your conservative that's what in we we opportunity So to we're and as expectations. we'll set. explore how K, be XX,XXX start an there that We'll can the U.S. recommending in but we

a what ASCO. in to And terms In this it's I'll is hearing been from reaction of And breaker late some at color reaction. that I a Yes. data, accepted our highlight positive was customers. very just sentiment. It's it Frank. the strong add think in as we're

of as treat as are part area the So engaged of as and who of well we've an need. who the this TIs reach study high glioblastoma our seen with interest here out customers some see unmet

comes from Evercore ISI. of next our question And Vijay Kumar

is for This on Kevin Vijay.

opportunity the FDA. At [indiscernible] an this for for to ? meeting FDA on [indiscernible] question the Specifically indicate [indiscernible] the come meeting? is follow-up a Just back to And your there cash with

question. Thank you your for

panel, option. we supposed we that do know not were meeting, can were when about in But as during an FDA it. states there the mentioned things. many in principle, the the the is So And panel a to was

that So we a believe not have we will still panel.

the it expected Got on time changed fourth data prior quarter? like the half now of in looks expectation this it. And the of PANOVA-X year. is line, second What versus

Yes.

So nothing's changed.

stage, -- XX trial the out the we by the trial is designed last following in when this we're read a when the to way, the So in. in. was patient Bill, we last patient is months announced announced This that's

cleaned. still out data on after to read We the track are are

no in the So change expectations there's for been PANOVA.

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

for kind advance the METIS potential could you're on you Phase potential of provide any curious Congrats separately, looking submission coming an major are based that studies on to timing PMA your into III and if your that any of progress. then later-stage now studies new I'm study indications to kind end.

Emily, I think too those On [indiscernible] transparently, both of points. it's

footprint is analysis fresh. our and to that like would disease. indication go We're metastasis doing options very we with the the of range now where at So current looking given a

it's comment simply to too soon timing. on So

We that more you message our we And pipeline. actually on news. same offer as update all would will I have

commitments that that last shared and November. We in are the shared to strategic we committed executing we prioritization that pipeline year

significant the advancing is to clearly Keynote DXX in in extend also our We come updates but opportunities continuing applicability, know And and on with what we we to we has won't GBM have survival focused we'll trial on lung cancer. our be back is pancreatic that that further trial therapy, invest done focusing So it is GBM, broad platform on that as TRIDENT is we're believe there. them. a that's This today. with

Bill to remarks. for time. questions further turn like no closing to back this have We Doyle at I'd it

and a everyone, of analysis milestones in present our executional very in progress. continued XXX-day quarter primary joining its and pleased We're FDA with sitting period is process, we're is we including, and late the enrollment that thank first data. now Europe. acceptance the in at NovoCure. important achieved, you, and a pleased timing and stand meeting was breaker TRIDENT morning interest a real at regulatory the METIS and we're described your QX endpoint both the ASCO. with Asaf in We're the as for U.S. as releasing the this to course, for those our study to So very where us, pleased, very of complete,

the achieve with getting X a terms when working the like FDA DXX, we based IND of in the always, milestone the course, very with milestone exciting immune ground. that's of that and top for As the off trial of a data approval is on important that, checkpoint inhibitors up

And updating a in proceed we those then clear lot erode. debt to intend to on And in answered team, finally, terms, our received and more forward all convertible of the about there's we've that financing were Have We Big thanks we have bunch day. underline. calls. we on the the balance on patients a path prescribers. questions very our have come very financing. we it and future morning, made how I'll We everyone to in the to good this to on announced we to know XXXX. questions how will But thanks, a profitability. you Thanks retire to progress our going look think good the with that sheet

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