NovoCure Limited (NVCR) 22 Feb 242023 Q4 Earnings call transcript

Good day, and thank you for standing by. Welcome to the NovoCure Q4 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.

you performance. us thank fourth 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 the

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

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

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

your line questions. we today, remarks will our Following the open for prepared

Doyle. to our I will now the turn Executive Chairman, Bill over call

the programs. Tumor many our in forms mission extend Fields. product survival reached development most research cancer therapy In commercial, the novel we commercialization of important NovoCure, is Thank through strides Treating milestones you, notable and clinical some At and and our development aggressive XXXX, made Ingrid. our of to of in

patients GBM, therapy. with X% treating growth patients with business, in finished year year-over-year Our commercial on active the

met Our and LUNAR are additional end Phase initiating PANOVA-X LUNAR-X III We point. trial patients trial arrays Phase cancer in launched regulatory trials, U.S. to to DXX enrollment which bring in arrays the and the filed sites X X METIS enrolling we new our protocols patients under of in in introduced the completed cell for We supplement January. trials, and next-generation a PANOVA-X, in countries and KEYNOTE III now its primary European and We new of lung completed enrollment TRIDENT non-small clinical several are successfully review. PMA LUNAR-X and the approval of

Importantly, we year and therapy. have a ended over now the operations, patients with first XX,XXX we of active we patients commercial number treated record on since started

incredibly and XXXX. proud of to look am our achievements I catalyst-driven a data and colleagues' forward

for NovoCure important horizon. the an XXXX more year is milestones with on

on focused objectives to objectives: success cancer laser clinical GBM non-small core our these in position for are achieving Achieving X and come. cell lung for growing and development pipeline. We our product company TTFields years business, our will launching delivering

cell lung non-small I'll program. and review cancer GBM morning begin a our with commercial of this business

review Asaf product clinical performance. updates of provide by will followed financial then Ashley's development trial and our

achieving sustainable growth: therapy the $XXX XXXX Treating for Our Fields is these key our enhancing the active achieve the revenue on compliance levers of in is in and to for to growth and million to our markets engagement building year. patients success. a commercial for inputs business and X,XXX of net patient country greater quality we We duration. central focused XXXX. on on Tumor long-term approach outcomes GBM a To patients engagements, starts, in synchronized key are growth. with the our we goals, prescriptions, best core these cross-functional Driving ended and objective alignment awareness focused a growth critical of is seamless prescribers and therapy patients are and with Each generated record and driving

We data-driven have always been a organization.

As to provide best therapy clinical health TTFields to into inform care providers the move determined we their are integrate use. data TTFields to further therapy practices,

real-world of with evidence. the was is The a XXXX. half of effort a trial, landmark and this large year. bottom the we provide real-world XX% struggling Optune benefit data U.S. A confirm of X-year newly critical real-world will which survival generation patients this with III this data Gio Last part compared at therapy that month But of patients real-world patients data These TTFields treatment who sets historically. in real-world for to be is new Treating these added for all published treated later is patients the for XXX XX% worth reviewed began Tumor the peer study, the It survival temozolomide. results fully of EF-XX clinical included line analysis Phase survival patients noting to in treated rate devastating second disease. a from preliminary chemotherapy support X-year the which demonstrated can alone X% and that significant Fields the GBM JPMorgan, shared diagnosed with

to As increase real-world working data, more will we physician be awareness patient importantly, of of data. and to the generate we awareness build outcomes continue

to enable of is and assistance our prescription physicians at will more higher time therapy can adjusted in We provide modality more we support patient engagement of deliver and patient the organization to unique To seamless option. experience. have that As will Direct choice support as patient believe hands of know our teams starts patients we therapy and on the therapy the written. early integrate with to physicians TTFields patients a journey. our drive is a considered physician conversion end, with this a scripts engagement or earlier drive

of Fields XXXX objective key in second Our lung the cell cancer. non-small regulatory successful launch and is in approval Tumor Treating

only TTFields positive announcing in therapies. patients Since patients LUNAR chemotherapy cell of top trial. compared XXXX. progressed and reminder, a standard a showed data, goal use who progress second-line towards year, cancer who statistically line LUNAR steady last platinum-based have published and survival use made and III commercial standard lung we the of who results meaningful Phase to for therapies we launch clinically As our benefit significant on the LUNAR non-small

we regulatory U.S., markets: subsequent In formally accepted the December, with PMA the next for their the At the steps. necessary and FDA the mark, review. X to our will and major anticipate our the filing Europe is In FDA we under submission discuss submissions filed which mid-March, January, Japan. now meeting PMA XXX-day occur in in

to Europe the steps and months. in decision Japan. U.S., and next engaging to are look with team we any in FDA fully Our regulatory is prepared coming Outside awaiting we address Mark in questions the CE forward the a

the receive the U.S. is XXXX that and to similar our approvals, patient engage Germany U.S. named Pending reimbursement. and a goal in used in the establish we the to half. GBM. first Germany Germany regulatory following U.S. to the approvals, launch in approval We payers reimbursement launched in and when Once using plan patients will to we on immediately half start therapy second in process we marketing of in we

We the are more at chapter patients eager to treating to open months. forward this in look potentially NovoCure coming new many and

fully deliver and PANOVA-X enrolled top XXXX, teams METIS line are trials. patient the of follow-up. clinical trials Both and In will now in results our also

year. XXXX. NovoCure timing quarter a announce trials It's momentarily, very material to exciting new discuss approvals be in or data could going indication indicates but will these of Asaf every

as clinical I new of former pass like Leupin, welcome publicly practicing discuss a Before Chief biotechnology most to Officer, Dr. to achievement, the already. NovoCure I who NovoCure Nicolas Human who has Medical call additions proven contributions welcome important programs, would brings our experience our are joined to the to and is joined Nicolas. a our of Dr. leader valuable record track wealth operations clinical January. Asaf new and as at Leupin Officer, team. Nicolas our of a oncologist in companies. in making QX Resources some and Michael, executive to innovative Puri, Nicolas Welcome, Michael he great Chief and XXXX, of a

turn now discuss to over Asaf call I'll the clinical our to objectives.

you. Thank

we pipeline. launch cancer our are X objectives GBM deliver focused grow Bill XXXX, on mentioned, our in business, lung and As

and indications have cancer. temozolomide further. an where GBM regimen efficacy but of newly and Gio survival we trial preferred diagnosed standard We considered have needs. and proven our can cancer NCCN can even into together These GBM extend with therapy consolidated care, significant address is lung in pancreatic clinical X initiatives category we we unmet cell are non-small Optune X believe

We Phase focused goal. X this have trials III on

X the months standard TRIDENT, studying earlier first The rather to today's TRIDENT is after starting which completed chemoradiation last survival than benefit than enrollment Gio X chemoradiation with protocol. Optune month. is of

last patient patient cytotoxic Clinical be that more radiation can entity potentially top of the available results studies can a line a to survival. preclinical XXXX. shown mechanisms environment has research together of and create extend cancer from cells for in follow-up fields TRIDENT XX-month action pronounced work will and in, have

from updated compared median trial our the data top Phase X-THE-TOP. a exciting match Tran we annual EF-XX TRIDENT, III Keynote clinical the cohort preclinical for trial. David submitted months was for data II XX.X meeting treatment Dr. confirm data Gio, to have initiated from FDA the and diagnosed Tran temozolomide At IND to and In pembrolizumab Optune newly trial. to control the the was overall Keynote Dr. in are of The patients the launch presented immunotherapy, to Phase survival November, months to study in Keynote will the DXX addition GBM. of to DXX this new XX.X from and DXX preparing research the set.

technological survival The are and on to new to demonstrate DXX improve year. to We and and enrolling arrays, further information oncology the programs in these DXX eager patients launch improvements TRIDENT, very X-THE-TOP Keynote we results II for our like field. sharing GBM new this Phase patients begin promising are commitment look Keynote our future. to possibilities provide forward continued the more and

The was the also the number the provides a cell focused the on and LUNAR-X, for for initiations. cancer. we additional lung site cancer treatment Last year, LUNAR of approved are foundation trials. of success began non-small IDE of trial We lung

first-line LUNAR-X cancer. will The protocol and cell for LUNAR-X use regulatory chemotherapy in line with use to immunotherapy the following later second Phase will hope non-small under LUNAR-X of review is the evaluate by and launch first-line this we platinum-based study the and immunotherapy in immunotherapy. metastatic trial TTFields together pembrolizumab TTFields year. authorities, II the lung of

or metastatic patients to in trial, continue Phase of II non-small TTFields cancer. cell locally treatment evaluating enroll advanced also and the therapy lung pembrolizumab We first-line KEYNOTE-BXX in

success the lung non-small of Given cancer. we are TTFields of believe surface LUNAR, the potential scratching of just the in cell we

We of tumors. of exploring for treatment use TTFields also are secondary the

patient trial from enrolling for in for We METIS cancer. will the Once of radiosurgery significant population. results METIS at III addresses studying line finished stereotactic lung weeks. top minimum to coming Phase XX-month the end follow-up unmet TTFields is March in non-small heterogeneous in, a Our a follow-up need the in last complete cell announce following is METIS we expect patient brain large complete, and XXXX QX. metastasis

us eager if lung are We KEYNOTE-BXX non-small LUNAR-X, to understand unlock availability cell to study these and cancer allow across the aggregate, LUNAR, TTFields patients. trials, will to of provide of X benefit program thousands tens cell TTFields patients. LUNAR-X, to stages TTFields use have of METIS. lung include of cancer of potential for trials These non-small and the multiple our In can therapy

in are is on cancer. The focused third clinical program we pancreatic XXXX

in announce nab-paclitaxel have treatment of X last advanced together top III for year We of to PANOVA-X. cancer, enrollment XXXX. pancreatic cancer. results the PANOVA-X Phase and expect ongoing locally We is first-line of in trials evaluating and trial line PANOVA-X the with PANOVA-X clinical pancreatic use The completed QX and TTFields gemcitabine

is We trial for first-line atezolizumab data is Unfortunately, great used which the need. is possible. to as PANOVA-X pancreatic trials from of as PANOVA-X look to forward a cancer the soon unmet an the II there PANOVA-X immunotherapy also pancreatic in addition growing the launched regimen treat evaluating reviewing these metastatic last the that cancer. to year. We and indication is Phase

also for we exploring mentioned arrays for we new the XXXX, U.S. of half In we on the the to through therapy the our patients encouraged for our ease horizon a GBM. catalyst look forward If to in positive. supplement As XXXX have in approved, approval comfort market PMA December, previously achievements development. by opportunities next-generation increased the in the product we launching arrays I'm XXXX. are this in U.S. Feedback excited in to and year. In launched our extremely been filed use. of and second Europe Patients improve mentioned, has

need. our I is team energized the on our to focused on progress updating you in reach objectives and key to year. throughout forward Our patients more all look

Ashley now and our will quarter through performance. full run fourth year

generated the record progress you, quarter fourth Thank We XXXX. million an NovoCure, on ended XXXX. X,XXX active another Asaf. $XXX patients in a execution year the and setting the We X% the year. at strong was for with from of quarter a million therapy, $XXX in The stage year-end revenue quarter of increase for and net

growth of objectives business. key is GBM this year One in our to drive our

payers. to German on XXXX and in is variables with strengthen the As directly for a and therapy, French NovoCure's therapy resolution the business several and most 'XX, net beyond. into patients resolved. revenue largely payments, affected newly to these launched been of our aligned foundation includes The growth complex this of we every transition situations have function tied serves negotiations baseline have This of the in depletion of flow years market accessible that our achievement backlog duration team of of drivers and revenue these price. to successful in enhance in recent to year support Medicare active

in of France. launch victories quarter fourth of success continued Optune was in One our the Gio the our

in throughout to tailwind our fourth This EMEA contributed count and million into XXXX. a we the patient in sets quarter. baseline France business as move the was year $X active a Our strong

fourth saw in and prescriptions on Germany strength patients the also of therapy. XX% we XX% In in with increases year-over-year active quarter, in

our with As payers that terms mid-XXXX, negotiate paused to contract updated German we a business. reminder, engaged effectively in German

As quarters took approximately recover. to expected, it X

fourth Moving German to day-fine as for market. expect our the quarter forward, we the serve

Gross for the XX%. quarter was margin fourth

active of expect in For of count near-term improved offset scale and array. factors, time, be manufacturing gross capacity affected optimize color, patient efficiencies these new we was by next-generation by factors and rollout our increased as X patient support arrays. In margin to with investment we our the increased

value and to we realign Last strategic long-term prioritization creation. our support to portfolio implemented year, initiatives restructuring growth business near-term and

growth we will of our cell also This of in We to burn. expenses, streamlined future us result non-small in our path million need but lung the to cash investing our initiatives accelerate our believe invest immense streamlining initiatives, in to recognize increasing are enable Tumor like a removing cancer residual As accordingly, operating these $XX without Fields we launch and Treating potential the platform OpEx. profitability. the

that extending are our forms will of the aggressive create rent cancer. position in achieving while shareholder confident some survival NovoCure We mission value adjustments most to of of

$XX SG&A expenses for million. the were fourth quarter

Looking includes ahead, non-small development cell launch in expenditures be launch. trial goals. our costs the global and commercial and in were support the $XX will infrastructure and with SG&A to quarter highest Research, ahead areas XXXX growth preparation with cancer This alignment of clinical million. anticipated distributed potential our lung

Our tied clinical R&D at moment. spending is largely ongoing to trials a the number of given

Phase are launching III and As trials of LUNAR-X including the of the DXX. of we current trial nears process set in Keynote next fleet conclusion, our

focused non-small prioritization GBM, Following cell pancreatic efforts areas cancer investments will lung of in future our year, be cancer. R&D highest return, last and portfolio

XX, totaled investments $XXX as XXXX. Cash of and December short-term million

Our $XX quarter fourth per net negative million $XX $X.XX loss for was the EBITDA or and million. was adjusted share,

are with investments to are allocated vision. committed in As areas we come, align potential we of long-term ensuring years additional to strategic that treat prepare to patients for thousands the to the incremental

in profitability. to investments is returns accelerating sheet while on potential goal focus of our areas Our balance path highest and strength maintaining to growth

reach Janus Jeff the People mountain enjoy across to in can lives, climb close like anniversaries constant her In rock one together. married to she diagnosed I'd Gio. today to XXXX, were our and moved of of York Optune Gio uncertainty ] Gio California the scale we Angeles. XXXX, GBM more Avid a fear plans have of Jeff Janus like the of decided began soon Janus's the diagnosis, Optune They to lifestyle. an with and met treatment Janus Janus and Janus and highlighting moved on outdoor globe. passion. and new with across continued a Janus nature them mountains summits With birthdays Optune Los patients, the Jeff shoulder, patients' country to or are Ares life. GBM reminder enthusiasts, and where of and and scaling hike Janus love was pursue [ or Amid better their make to In of impact mountain. the helping City, to Jeff, New by

hand I'll that, the for questions. to call With the back operator

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

disadvantage with the readout. Ashley, headline should where your TTFields the METIS are in to and one advantage next the an trial? there wanted And then that venue I month. And full upcoming you or this consolidated in do Is of see you confirm a start brain I Bill, your in fact your areas data that you activity? using is wanted the anything in clinical planning read what So that we typical as to from see you to the first release to mets present X the then METIS into are the fact research monotherapy results?

Sure.

as eagerly Jason, announcing data, the the and So awaiting the top be we'll the line of at all we're correctly you results underlined, end quarter.

be venue We the It core fall [Audio presentation. respect spring conferences. the have to we the it focus of areas, in lung But will up, season. season. those This program. with we'll get would for we announced late of to slots. part will our Gap] then be And full applying not I for yet do our data be consider too the cleaned for When this be

the non-small form brain metastases lung studying of is This from cell cancer. is mets. most METIS So common brain

the within and cancer And that of pancreatic so we've it's core GBM, out cancer. non-small well staked lung cell

all top release. standard only how releases from the add a we press And this handled data you -- us there I but for similar yes, is, other of have line release to would thing can expect the

where wanted to to Okay. therapy here and of any try I'll of been a lot longer, ask looking revenue the then next noise but on the one Great. be think you've I meaningful. pretty background patients ask to ways sorry could of patients on duration here, I keep at for quick. And my

the have patients wait trial than after starting until TRIDENT radiotherapy where You complete. rather you're earlier is

and benefits, about Those clinical survival have know some to supposed wearing Optune day. for about longer got are the you've the talked think I I you arrays. the new benefits. educating patients doctors throughout

potentially You're on longer looking progression. sort patients keeping at of even after

So they where is could of of be of duration Stride benefits these couple individually, years, some see other from but not interesting. those could coming actually pretty collectively, a sooner? all revenue are extend for impact I we items, an guess, impactful.

for Frank is question. Leonard. the this Jason, Thank you

activities for how you and improving at the thank and use that survival. that have area Optune -- that patients are think ongoing this highlighting focused to really all of I in physicians we extend

new And think the the directly in a anecdote I a markets, KPIs where seen have meeting performance we looking well released wide array looking trend expectations to and that the I'd to key metrics point arrays our both in far, what to positive so of our patient as assess and performance. that is at been of we've are European the in as is experience. tracking

So and we have update come move I to needles we'll in. metrics as think of collectively, to the lots continue the opportunities you

Okay. Maybe Fair more. one enough.

forward-looking or it's the offer growth for if comment business? you know We more couple a outlook, any over a high point, about here. at business to willing we kind few level, the for different thinking you of years as seems next have level away at But this stepped financial to one of for you're or out Are it a back is had predictable reasons. to normal think to of I Ashley, guidance. year being like that whether the

mean the And provide would we we like you appreciate so the where we've question. necessary to ahead. we color, need I to is feel do I do. detailed what say can committed that look I always Jason. Thanks, guys color providing

We of a you in So baseline the Germany. to that. which in have on believe a major you've build GBM U.S., XXXX So Gap] through return focused [Audio business. heard that we all we're right? do can our upon growth in our growth, in markets clean message. We're largely

at growth. upon look we if a [indiscernible] patients active good So baseline which 'XX, it's

support the announcement last us in very year, QX will OpEx think directly state fully And launch. the which business heard that in we you then lung run residual we the can restructuring that our have, on we

rate, in QX. you at to look I that the expect we if would So infrastructure were running that able be invest we to run QX, us to our at OpEx lung run in launch need rate

the kind we we will where So I adjust. to those we I with any have there's to feel model. And need you need what continue messages, build up say areas of if think additional would to anchor you flag

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

studies the And First prelaunch question, following ahead launch And the ongoing? cancer and planned your portfolio Phase year? those balance are about positioned trajectory then and positive, approval initial the be could what and how activities thinking advance sheet like? question, look launch, lung X can are position up thinking last prioritization of of the are strategic are that cash readouts second should potential opportunities? about year, to this restructuring a we coming how ahead you you If and well about talk you III those

Thank United Jonathan. you States. question, Frank [Audio This Leonard Gap] for the is

physicians one Our and that on platinum this step. process. with areas understand to of their clearly focus that we've to core they first physicians of the cell treatment after very of to gap satisfied work with is is been second-line heard the education with And and treatment in with focus main mutual the simply this, for really are advisory on non-small a that we've acknowledge has through potential working the lung not failure. there cancer. Board options and understanding And align we think prescribers now engagement is seen this direct the from physicians And

both with is really through. we're engaging and them And we Gap] in acknowledge the today community process launch able plan physicians to preparing the our activities where where new Germany are through to also help Germany we cancer, the but to with in the in Germany, we've in to the been pleased engage also curve ultimately are in also U.S. Lua we for And have prelaunch through oncology and of to we cell the through launch. do the I'd Fields, modality, in in are to community which begin from market through to a the go education this lung and note, we them Treating Gap] introduce KOLs there, help key key pull the waiting the Mark. for Optune mesothelioma prepare of terms phase we and non-small [Audio [Audio understand in engaged CE Tumor for prelaunch in educate that education medical to

one I other Jonathan, I is this just GBM reimbursement that mean that is look launch would model, as when tech curve would a the launch dynamics. the we And curve, to thing, the to flag our curve. building in, to med in this and I as stereotypical not look it everybody the biotech is comes particular,

Yes.

too. to the asked there between other our respect the our we cancer the to strategic the again, think plan as is it's overlap for of are and question cash I preparation for launch readout, we finance prescriber was key And launches. And with fully part non-small you these cell METIS groups our anticipate lung there, prepared position in that's budget.

METIS So if radiation oncologists oncologists their who is lung after primary who you'll that along treating patients recall, radiation the is the these we is so non-small in GBM engage medical treating principally the oncologist is with cell business treating our patients, stereotactic cancer. radiosurgery,

a cancer potential a believe cell we covered non-small pending and cash from outcome well of perspective, the So METIS. launch lung launch the we're for

next Biegelsen Larry And from comes of Fargo. question our Wells

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

Lei. can, We

more to pace on we of using base. to guys about think we balanced one Should should should a prescription any a we XXXX, 'XX? sort some XXXX? far for well think detail look and to is, in of we about the that in guidance as XXXX growth? how did from should as as provide I active you there Can actually, you the some And And growth think growth give relatively related how as patient follow-up. about GBM XXXX? The think And have through don't expect Is acceleration give about? first lung in contribution color that, some

to which said growth grow what levers what here I what ahead And I XXXX will the prescription yes, all other we XXXX room all we're there, growth, we expect growth. I come to is from what starts duration. be increasing look reiterate to to to to grow doing continue done baseline we scripts to come come clean do fundamentally those will see we're to to France XXXX. than do will is to are from patient growth off growth, earlier QX. teams grow mature of And you looking we can are that baseline. of can not is and incentivizing everything in there of I the to and think kind our say from as there, look be do yes, and Lei. expect there are you Thanks, strong going seeing we a geographies. can don't France, said will say, are markets give can we focused a like. But conversion we of would -- that upon in just grow to we which on think -- additional clean And that better detail XXXX active levers, from Yes. able transparently, we on I think we

Got lung in anything as contribution it. on And 'XX? as far

very this material one 'XX is so in expect No, model, you where would we Yes. contribution dynamic. the your conservative guide because of revenue be we reimbursement in XXXX would

age patient those [ cycles. will but So couple begin there take get through of quarters ] appeal on first it to a basis, we an does

revenue but to begin prescriptions in and your of active accrete first adoption indication will materially be really XXXX. patients, So then there will leading

Got it.

check kind then you my of you point. keeping is reach that we in And announced expenses until follow-up Okay. you when [indiscernible] a about plan talked recently, breakeven

something talk about on thinking around GBM math, over you that a we in total but it Obviously, you order the total how for as breakeven way And Can $XXX get timing revenue. to of million provide drivers? and point. color can revenue little growth in right it's any we did as in about And just so we the reach the pathway far lung, when are in mark? Now now, you're right additional million $XXX that there? you that to million color on get $XXX you any or

I'll say, Lei, you summarized it well. very

would fact, In with track those. you're agree with I on would I your say, thinking.

you work if rate sure includes the that operating of we business profitability that hiring line the we're out back to expenses, that in half the we'll of able scale And course, last growth growth top the scale done that fund have year, lung We our the on on we of path by were a driven exiting we then at QX, removed to the make run are existing growth. through able be is -- to to the cash number. and the that correct year look that that,

would say well. you've summarized I So it

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

the launch? confidence Could you're Europe the did for soon clarify how that approval, would think FDA after CE when lung be Europe? receive you for And ready you does And that Mark your to that second-line of you kind in expecting increase assuming you approval?

expecting for other So question? the last body first submitted we're the what year. July, half you thank in was [indiscernible] this Europe materials We and And is the approval to question, our this in of the Asaf.

FDA. the to [indiscernible]

forward filed. in which December, looking last which next we that meeting, it March. be of XXX-day we it package will And the step, and PMA just for submitted expect received was the FDA, the confirmation be a end for to we the we're

be launch? soon How to after ready would Europe, approval in you Okay.

We the will with ready launch to be approval.

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

on levels. on Kevin Vijay. One for is This OpEx

are number expecting of And up grow the $XX for savings, follow-up, XXXX? inclusive see in noted terms that should we million flow year, of clinical given we in expect what OpEx You a Or the in to for should OpEx line step free of you cash trials? a just revenues? with a initiative

Yes.

to our enable up So million year, the near-term is has again, intentional and but which to LUNAR-X Phase launch invest it DXX. that able we're fully both that expect to onboarding our long-term this large fund of coincidence $XX the to ramp of trials, Keynote we growth priorities, and III happy lung principally sufficient being the in and also really

that restructuring burn. 'XX, the And about the year OpEx levels should expect did. full would cash that be line we you say with 'XX largely So to statement same for in the full I year given

FDA update noted press it. FDA? to on release provide with put then know let program, your a your any in mid-March. Street Or to would the expect March? about you in the And with Got a Do you meeting you LUNAR communications out the

have we'll public I press is have material sure Yes. announcements we say. has would as make FDA you information I would formal release relevant the mean tie to the it, when what the

to would Doyle turn to like for it closing I Bill now remarks. back

and for many closing hard to milestones my that achieved. by start the in to NovoCure their my team like I'd the XXXX remarks reiterating were for work thanks

Our our company help our of to proud. bigger, difficult to am I is which very mission but more team's something complex, with very is dedication patients diagnosis

we an 'XX are forward as exciting was, looking to more As even XXXX. exciting

going we're to next trials year. this we Europe that X arrays enrolled PMA cell As lung our busy fully throughout III get time, And follow. we've to our will and Phase We're really big X this have excited supplement read launching but discussed, cancer, extremely approval exciting. and indication. after are It's out to extremely year non-small our next-generation rolling we

the for on today thank of as results to all activities forward we these So I everyone call continued interest in the and their of reporting the NovoCure year look progresses. want to

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