NVCR - Earnings call transcript Q4 2021

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

Operator

Good day, and thank you for standing by. Welcome to NovoCure Fourth Quarter and Full Year 2021 Earnings Conference Call. At this time, all participants are in listen-only mode. After the presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised today’s conference maybe recorded. like the now Ingrid over I’d Goldberg. Instructions] to conference hand to [Operator go Please ahead.

Ingrid Goldberg

thank joining Ashley Q&A. are by The on I’m you also on slides NovoCure’s reports and today in Relations Danziger; leadership available on Chairman, morning, Good for Investor team the CEO, our members the viewed and phone our Asaf year of Bill the www.novocure.com, executive call Doyle; fourth the page. our can full financial for our our link us full for website, and XXXX Other year on clicking and the performance. CFO, be quarterly joined quarter results of and by presented fourth section Executive Cordova. XXXX quarter review to our located

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

this questions. prepared Following I the of we X will will in call both our ended remarks Doyle. that, and now our and release our earlier XX-K XX, the Financials in XX Chairman, months your With open to XXXX are for our floor morning. today, turn December available Bill the months press released which for Executive over

Bill Doyle

Thank We be you, can NovoCure good novel division. harnessed observation to electric cell and founded everyone. that to morning, fields cancer the disrupt explore Ingrid,

bring to tirelessly has forms cancer. the to our two worked patients, Over of decades, team extend Treating subsequent therapy survival to most in of aggressive some Fields Tumor the

these experience, Over multiple pivotal immense the our future. trials, knowledge which an completed with business, and fuels confidence commercial of amount gained durable patients clinical treating built a years, and glioblastoma in we have

potential two lung And the of team. cancer. cancer. in completed ovarian with full XXXX the first achievement We the are trials, Fields research, and platform cell and trials clinical Tumor of year academic another of the to for was We the business strong. recurrent collaborations The the partners. develop continue NovoCure our enrollment of industry pivotal Treating fundamentals centers in second randomized through non-small

shift to treatment top from which TTFields could with a enrollment and in trials GBM. We Neuro-Oncology pilot immunotherapy two of were exciting cancer, the together studying Congress, society with the sponsor also paradigm a investigator of presented at the completed gastric clinical lead study of the patients data Annual

objective GT and to in Genentech demonstrated which clinical data Roche, includes and advanced our control now Merck, released our an leaders, which from study in are the the and and cancer, rate patients. Treating we liver latest We poor building oncology convene around announced Medical. advances rate also encouraging revenues. generated the where we in training response a network, We collaboration Tumor learn prognosis study $X.X world-class expanded partners use pilot We and of development in billion disease net Fields can world center therapy, over from

and may approach the just progress it iceberg a our this for we key in our as is today’s impressive believe we inflection recent updates call, will as core of business. first the company As be, patients. tip In point discuss we GBM

our clinical pipeline. We in will review then developments

our model. discussion close the our we and strength Finally, of a provided will by fourth results financial quarter business with sustainable

business the headwind financial GBM geographic is the for business it critical in investment of long-term GBM successful NovoCure’s is core is only engine commercial a in driver providing our blueprint a and growth, Not was expansion. Our significant successive future launches COVID-XX fueling success. XXXX.

diagnosis With treatment generated we Optune U.S., consultations broadening Nevertheless, opinions, year-over-year. GBM in second academic or in and penetration through institutions. of institutions of $XXX see whether the and revenues we the X% throughout remain surge physician increasing underpenetrated our these GBM settings. Omicron academic repeating adoption flows engagement, majority an staffing net from primary for restricted our focus seen of patient a point key is delayed In of the A hospital business, stressed and of year. million increase patterns

providing Treating for of patients. understanding for about to like for learn academic clinical the academic that and opportunities two oncologists every to increase oncologists therapy to committed Fields are their I would centers underpinning benefits We engagement. science to highlight the opportunity Tumor

investigator-sponsored supports of diagnosed interest new drugs trials. academicians, patient populations. explore study, to topics a of publish program including GBM. variety IST NovoCure XX areas used opportunities trial potential indications, informs with NovoCure’s including ISTs unique new cancer for in Our therapies clinical in and research and the and ISTs. newly active trials or pivotal and program oncologists findings TRIDENT their other offers IST combinations and perform further Currently,

the important at Neuro-Oncology Brain as in Florida the GBM. breakthroughs of such Tran, Dr. to the lead Division X-THE-TOP Chief of by potentially McKnight the conducted also University Institute can ISTs diagnosed study Our of newly at David

pleased are announce Clinical manuscript in release extremely in published morning, seen Investigation. of Tran’s this week to As Journal this the our we Dr. press was

reminder, a Tumor Fields Treating with was As immunotherapy to together X-THE-TOP temozolomide, pembrolizumab. with the study designed

Dr. November, In follow-up, months XX Tran progression-free Neuro-Oncology Society immunothetherapy. potential a of patients leads concomitant our of X-THE-TOP Annual LUNAR we preliminary immunotherapies together that anti-cancer TTFields than using TTFields death with immune with and trial, use reached an benefits XX.X hot explores that very to presented cell becomes with encouraging. As specifically tumor response whether nine such for Congress, found the survival formally cold induced which data, had greater at for In months.

improvement for the For for perspective, the a cancers patients. they the TTFields to researcher immunotherapy observed of proved engage the four revolutionary Dr. Tran’s survival of avenue temozolomide in achieved prove EF-XX agents an study of treatment a far exploring progression-free centers. treatment is study X-THE-TOP is position GBM this a temozolomide NovoCure X.X TTFields months to TTFields controller. compares of may might The plus nearly IST to and with the alone the effective to so research impact potentially ineffective. months they EF-XX change NovoCure’s science, GBM is from for X times in sensitizer patients, and provide pivotal have as which second driving that key most clinical performing uses clinical in example trials and sponsored academic an landscape a

NovoCure protocol to of with protocol rather in treatment TRIDENT diagnosed radiation Our earlier of reasons. for therapy GBM GBM. radiation the than the testing is therapy critical is the principal use concurrently in introduction newly following Studying TTFields Optune two

treatment patient’s and First, in shifting may extended better of to on TTFields the to introduction a time earlier outcomes. journey an lead survival point therapy

specific oncologists. greater awareness TTFields it We engage increasing among of Second, allows members the members to team of with radiation a the is additional benefits believe to adoption. patient’s all oncology of NovoCure key treatment a team, of

with at sites opening enables several goal long-term In of strategy. this opened of have all We another at the is centers TRIDENT our expansion our growth component academic year. centers focus Health sites remaining Geographic TRIDENT in France. key team of recruitment we the negotiations ASA earned of from X our July, Optune engage French to ASA had ultimate the An in reimbursement reimbursement national announced X an Authority. achieving rating rating goal with

price and to of the patients the with expect treat and by final We of end Authorities negotiations in are French XXXX. Health trends stages

the addition establishing to potential heat morning close by issue. factor foundations create in Treating Canada. The daily Tumor Fields new mitigate These as opportunity use France, this number establish research skin anticipation and comments my I product limiting Europe our the our effect. the generation. enhances cell highlighting development like believe across are commercial shows Preclinical cancer to practical serve we and would that is milestones. markets have markets killing In intensity more arrays commercial in a of to as increasing of launches. next-generation We the intensity recently the well other future infrastructure heating field to patients GBM announced

Our shows region next-generation our Treating more tumor. to a a arrays can higher, the consistent of deliver intensity Tumor Fields research patient’s

about in Our as be greater our more next-generation improve development of of increasing provide and penetration. comfortable range the our motion. lever designed next-generation patients and potential incredibly lives product am for the be arrays also to this are to arrays I therapy excited milestone could another have

our Tumor to position most Treating Asaf streams to markets priorities, We discuss With organic the the engineering, in allows the quarter. are pass many growth call to ultimate the extend of over from improve through the to limited is new new therapy of commercial further with privileged fueling survivals year. aggressive some in our EU extend product product this cancer our working The release business our with on anticipation cancer Fields our reach revenue updates large NovoCure therapy our later improvement goal of our core into cancers. indications all can in I the We of select clinical geographies. regulatory that, now durability opportunities initiatives. to the and and is teams and to will authorities a in platform strategic platform have focus

Asaf?

Asaf Danziger

Thank Bill. you,

sentiment In trials like iceberg patients anticipate just and our data tip transformational would of we First, could the pilot data from the numerous revolutionary the XX for be which next NovoCure. company. I Bill’s three studies, XXXX and that achievements months, our are for registrational echo from to for

we point, future. enrollment protocols of finalizing our approach our also trials, year, are two to X completed INNOVATE-X. in in this clinical LUNAR growth and development maintain the wave Last critical we inflection of Phase we for pivotal As next

treatment of with from docetaxel reminder, physician’s cell PD-X our the trial LUNAR studying follow-up has a TTFields the non-small cancer. XX-month patient As last choice LUNAR inhibitor in. is use a X for of stage or lung

The in and XXXX, in the recurrent analysis we We line are the year. top INNOVATE-X are the committed end completed from ovarian data by enrollment data of awaiting also sharing interim to trial monitoring the independent cancer committee.

are encouraged the DMC of INNOVATE-X, we while have two their for events disclosed, arms enough by the occurred recently in complete rapid interim we review. As enrollment not the to

time second trial, the public. in We data not we adequate events in of complete from which we time expect XXXX. and their timing this an impact analysis, the quarter, for number will their DMC the will report make of the findings does line at expect This which

Moving pivotal brain our metastases. in trial METIS to

We year continue to patients final later in enroll with enrollment this expect data and XXXX.

in along enrolled Lab, to suitable using our our monitor Finally, in of that identified uninterrupted and for data the first China, continue we we China a global pivotal XXXX. have trial shortage enrollment, patient we trial pancreatic the continue Chinese we ABRAXANE expect announce ensure PANOVA-X ABRAXANE pleased in generic the Zai are to chemotherapy partner, with to of final to cancer. impact Outside

Looking next in generation partnership with data study our of are clinical pilot trials. excited Zai expect gastric in mid-XXXX, In Lab. about our we cancer we ahead, from

for metastatic therapy our collaboration are clinical protocol will Roche treatment study with pancreatic anti-PDLX We cancer. which the TTFields Roche, the of also with together finalizing trial for

of As research and therapy new thorax clear combinations, data the and these head, to regions remains look of our we capable the generate in impacting cancers that body. in in forward and cancers continuing abdomen to continue it indications is our we in

would like on to a congratulate handing team I the to the NovoCure a to successful call moment Ashley, XXXX. take Before

to dedication I excited forward thousands I’m like our to performance. of many over innovation been, mission patients the we year. have success. mission, to years commit the and their will the a have our fourth another future. my hope I fresh that few start help Ashley quarter it pass By continuing in last of discuss is for the as to daily the additional of challenging I today, opportunity As new will for the that, NovoCure would With to and thank year our look call to team to financial to

Ashley Cordova

position. financial finished NovoCure strong a Asaf. year in you, Thank the

revenues initiatives net in revenue the The new XXXX, $XXX greater in includes pipeline, Our from and $XXX a the of XXXX, X% business in in our core business of we product generated future. anticipation million clinical fourth net not year. backlog. of continued This in from investment future commercial designed to our GBM million did prior revenue the the readiness specifically, enables quarter record generated Unlike efforts revenue. in potential development of drive organizational we Medicare an increase expansion launches. our fourth In recognize material quarter durability

per We saw also come active with the lower quarter, in net our due German to per in revenue patient specifically slightly month payers. negotiations

We with provides EMEA year. last largest efficiency which a foundation X% U.S., X,XXX Germany, strong This public year-over-year with from the stability Japan, a enabled patient respectively. and new therapy, same the of negotiations long-term XX% We X%, in reflects active price time increase and the ended patients year operational have reached on payers and and an in in increases for X% markets. agreement greater the

penetration to will coming online active X% full current markets New and patient expected our patient between drive in and in X%. XXXX, active year volumes greater growth markets continue with

Moving P&L. down the

Our with gross or million This a has $XXX the which our fourth gross consecutive is quarter quarter in margin XX%. seventh was of XX% the gross profit been higher. in margin

We product we uses new research footprint, as innovations our continue our to launch sold expand of best one for indications. of capital geographical development. opportunities cost believe prepare our to of We and evaluate is and goods reduce

cancer XXXX designed a enhance populations time. as million addressable record $XXX indications, we invested for to R&D was patient and year offer. Our initiatives for product investment, new our than more R&D the are unlock first expand

invested in we perspective, XXXX For R&D million $XXX million in $XX in and XXXX.

number quarter $XXX an in XX% investment plan year through SG&A to invested While to launches. geographical R&D to we greatest either million. specifically roughly patients. in pre-commercial the $XX full over expenses XXXX, stabilize in million unlock of fourth of million, bringing excess our new year, expect were time, reach from for the to population, to was programs fourth quarter of and the of incremental $X indications XXXX, SG&A expenses level additional pursue intended R&D build-out we expansion Last in or future GBM increase investments patient the

Moving forward, patient anticipate investment initiatives new will incremental we SG&A intended focus to on population. in reach

per share net or was million. Our quarter loss for $XX the fourth $X.XX

and times many for the point believe we meet As to are a are ensure approaching inflection strategically investing we have moment. we said we today, key our company

focus remains organizational investment and readiness drivers of Our on activities and growth ahead earnings. managing for maximum

for designed was share-based and our to invested to EBITDA programs $X compensation new adjusted compared million was as the an $XXX of XXXX. total quarter net well bringing $XX to of in in investment million development due part $XX incremental patient in annual decrease million research in $X to million Our reach population. million, as This initiatives

operations cash balance and company, ended cash still on as we the million short-term are we flow year with sheet. $XX a We in ahead, generated from million and journey $XXX of investments to Looking in at XXXX the in our plan invest accordingly. beginning and the

bolstered GBM a business, Our cash the continues durable flexibility constraints variety without growth to opportunities long-term by believe to and organic be this we gives position finance of our trade-off. pursue us

net we the what the close have incredibly proud million on As we books XXXX, crossed we threshold. achieved. are We revenue $XXX of

and to XXXX. operator primed it could in will that business that, the comes. of number therapy. for exponentially strategically successful another patients our we Q&A. investing when set pivotal over turn are team execute we our years forward I to can finally, With fundamentals look We the our of benefit back time strong, from that to fully increase have The year read coming in ensure is trials to are out multiple the And

Operator

Our with question Instructions] Jason comes [Operator first Bednar Sandler. from Piper

Jason Bednar

Hey, or good you. I’ll morning. Thanks with Asaf, Bill for start taking the questions.

that INNOVATE-X, talked I to there’s to there we additional visibility more the guess, guess reading with some all the or of XQ. the we’ll the these appropriately, qualifier think But side think Just over your on wondering on in to. allows on wondering that of Am I days anything I’m comments INNOVATE-X, on I read don’t but if from today, understand in you’ll you I particular, analysis the timing specific I about aren’t you a And bit actually interim you want see point over don’t detail we’re either dial if as studies? you necessarily analysis coming early in heard the can any to trying gastric see previously today. offer prepare trial? I updates I when cancer all weeks early interim today and/or that?

Bill Doyle

Jason. morning, good So,

Fields to to very to Professor going learn the news. Israel Palti, trial. and and and Asaf the work developing you before call our interim I that, we gastric with And the to just question in pleased specifically call little just to Emeritus the – were interim the for civilian. Prize wanted Technion, But the just And and a few a Tumor breaking highest yesterday congratulate Palti. a Prize awarded I’m platform. to Treating We Israel on want to late about it Founder, to everyone the gives trial? about cancer for the comments Israel therapy Professor out that considered turn I Just the the Asaf, that is mention over answer honor The was gastric of wanted make that Yoram for and his

Asaf Danziger

for Thank your you question.

which soon. now announce Besides patients, trial all but going is we data, did the the is have I happen to and are we’re start with recruit we analysis, that. cannot waiting Let’s anything a right the data. collecting The that about that, gastric. The all gastric interim to like the

that our not anything as data to follow-up. when the after with to going share trial the basically Our planned. we that changing will expectation we about you we’re continue and will have it announce It’s

take you that continue as will planned. believe as So can it trial we the

Bill Doyle

Yes.

asked, So there’s to read the following nothing wording, – should anything, to you in so and up, you in here. Jason, read

the in year. QX, expect this we’re interim here mid the forward all data to We and gastric looking

Jason Bednar

And right, also maybe All the Okay. clinical to on Bill, helpful. Palti. Professor pipeline. congrats

Over the that past studies stages. talked are you’ve Phase year, in Phase and planning new X various about several X

as another here update far to I think, one, an spoke today. You as

capital all You’ve got balance with a your lot disposal the sheet. at the on cash of

kept formally been has that’s when willing And a trials more but these clinical matter commit timing getting pipeline? any discussed layering the into see development resources, of I really of So then past? isn’t of any and from details started factor in next a that there rate-limiting wave you’ve financial guess, to the studies those to this in we you’re might

Bill Doyle

Yes.

on stated, and this, underway position we’re we our you in not And mentioned instance, perspective, as the in that trial. by we’re So capital invest. we the from – actively sense liver, are working in trials limited privileged for in these that we’re are that to

yet We announced haven’t in the because FDA. the protocol discussions with we’re

lung news, hope of as there. course, reads trials on instance. going in if and We’re And actively by is for followed areas gastric out to there’s working core we be additional expect, X all Phase will in non-small additional the trials cancer, be cell clinical that

trials have hard next the our a from protocol. through with wave. if we’re announce don’t the we It’s – the and at until actually FDA, perspective, we finalized So at we’re work

is new wanted assure rest no to of in wave updates and should next underway. but terms the signal So that you timing, we

Jason Bednar

Thank so All right. you much. clear. Very

Operator

Our Kasimov with comes question next JPMorgan. from Cory

Gavin Scott

Thanks for question. Gavin is on thank the for Ashley. Hi, I taking for a This couple guess Cory. you.

provide patient I’m So about you color from is X% for where additional color context Germany? great. net decline geographic you. you per curious growth if range. additional on be any perspective, coming there could that You active in of just to X% from would Thank the growth primarily the primarily discussed patient the revenue a XXXX in from, talked

Ashley Cordova

Yes. Thank you for the question.

our short think So of the on to active focus we answer continue I is in growth markets. all

year. expansion the more development both expanded we’ve mature our France increase and Germany have believe, into such through we markets, opportunities, and prior the markets markets into we such as U.S., over So well of as to the penetration, continued Japan large, as as new in

short the above. in is So of all the answer

with now numbers what you use, regards per that stable say, if assumption just you would at specifically net look I the to think patients, moving active QX a I can forward. revenue we have, is fairly

impact numbers a in where will And so look moving take patient our forward. we are while say, mix that QX I geographical number stable that can you growth at somewhat, and out position, would

we’re going I’m ask markets. pause in penetration So The focused to is into if academic on centers key our markets there’s additional increasing any mature expanding both follow-up. large as and the new there and short on answer

Gavin Scott

sense. And then makes margin. That I follow-up the a great. gross guess that Okay, to just on

the some being I think cost to made you efforts sold. goods of reduce alluded to

what expect So the somewhat margin to And more are we be that I specifically, guess are efforts? you those stabilized? profile around

Ashley Cordova

Yes.

recent quarter So believe swings efficiencies. a above more to drive profile the this have think sustainable. And the fundamental you’ve efforts purchasing is XX%. that ongoing do our lot We have Zai with do to a I that that seventh of margin quarters margin in they is with with margin than seen do we

I expand on expect of that the naturally line, through know we add. we if he supply the do the don’t pressure modest on anything true top call efficiencies stay is maturation would there’s getting, to and our that chain. with of some would have scale we the we’re just ahead I Wilco we but why As have believe geographically,

Wilco Groenhuysen

Thank you, morning. Ashley. Good

XXs I margins seen gross reemphasize the our actually over year-on-year was I’d to think that high point improved percent. Ashley like I’d gross X quarters. full significant what out, by of a in like to we’ve pointing number out margin We

to improve the We a to address going on initiatives have margin, opportunities future. out further play of which will foreseeable in number

percentage in point pipeline. future full the So with I with performance current improving think a improvements

Gavin Scott

you. Thank Great.

Operator

with Our DeGeeter Kevin from comes next Oppenheimer. question

Kevin DeGeeter

Thanks our regard the comments to want guess on I question. next-generation with I for of array. introduction taking great. follow-up Hey, to

specific we the in sort right potential U.S. thinking rate-limiting we year? that the chain about of array? the Specifically, regulatory the as or introduction or clinician education with introduction of how that then a more of be supply perspective just maybe should Europe any next-generation either steps U.S. from array, introduction and in or to use later broader adjustments think And about of the familiarity to global

Bill Doyle

Sure.

So differences, therapy. the now one potential And device-based drug-based between of and it’s a a platform. we therapy, extremely mentioned improving course, about Within as I the of a for therapy are excited in comments, the our big device-based we the build financial a we that few that – in development, have the power to delivery focused And the product is to invest know the of have on we and and therapy. improvement improve opportunity can we areas.

First But efficacy the improving by and very focused experience. improving foremost, increasing patient intensity. the we’re on also

making the comfortable. patient use then we’re focused easier we’re So to as chain, to goal efficiently, them new on finally, it with products, develop for make less more supply the more comments, And to we ultimate expensively. – manufacturing Wilco’s

of and respect the specific regulatory. focused question, on rate we’re to them. opportunities step So limiting With exist, those is all your

the much expect use will if we’re in it these do we have And or supply tailwind terms We chain a barrier be anything, not will, training headwind. in putting easy any, comfortable, of because to much arrays to place be patients. more you in or more for expect physicians, place. If we it

a So on are EU. confident the rollout FDA. function the in – that U.S. the the dates we little of of more Europe regulators more reason not is we’re year we that where rollout we’re any can the The based is provide the specific this in with the begin in end that process a giving

of give it’s timing U.S. but us for a too rollout. engaged, We’re a early to

Kevin DeGeeter

our taking for questions. Thanks

Operator

with Lei from comes Fargo. question next Wells Huang Our

Lei Huang

taking It’s in my Lei Larry. calling for for Thanks questions.

XXXX. start that you your the X% growth the call. your to of on full That start obviously, guidance in those to headwinds mentioned the Just some X% was for affected XXXX, activation growth, the and at growth of out for

as another year? is, versus I bit COVID a the than question Or the assuming growth it you my growth end what abating would going are that think XXXX? make the at the quite look better guess, you be low last way, X%, could of slow through to at as put So we X% X% about

Ashley Cordova

year, durable the message think is Lei. the X% that for important I see to kind the continues do of to Yes. that to fuel Thanks a from see and innovation. growth is on GBM a which question, anchor And the X% sustainable in to growth cash our here it we last was growth, the X% that we and stable engine engine business generate a of that of

growth anchor to – in what came refine have them, and X% that what roughly XXXX. to say say, still reason this point, X%, at see would full I change that’s for expect for is So we expectation patient in that the X% that’s to we active too early that no of year. that the line us there would we – with forward. still the It’s the is landscape looking we see I that’s we growth

Lei Huang

Fair enough.

on Then study. PANOVA Okay. the

So that on the QX issue. supply a call, study was delayed bit because of the

us can anything provide tell call, margin gotten global situation. you worse, on if you you saw it’s as as far supply supply today’s the just what better, Can on versus think monitoring QX? you in I mentioned situation the

Bill Doyle

Sure.

trial. here, can and Benaim he comment Ely PANOVA with is us So the on

Ely Benaim

the deficiencies are we Yes, in The been state. major thank you the all for closely very the monitoring over have world. call. Yes,

with compensated geographic trial. have we other looking to – areas of the areas So at PANOVA really enrollment the

we that we a to that patient happy on first very were and paclitaxel and We’re a in already expect we the study, enrolled our able assure more that have was population. paclitaxel many large generic in China. hold And such

in we now, in and data So signing XXXX, guidance still early have to that right XXXX. last patient sometime in going is our we’re

not really are we So concerned.

for to the hard very patients. drugs working just We’re procure the

Lei Huang

you. Got Thanks. third-generation one TTF If ask I it. the generator? on just more. Thank may Is there update any

Bill Doyle

Yes.

our neuro and product rollout array TTF side of for last we introduce continued the to small The going generator. next on mapping was update the I MAXPOINT that also were no stated, update the are our the improvements system think for on as able applications. of be So torso factor wave And mapping. to the we form into – clinician

Operator

question Greg with comes from Truist next Securities. Our Fraser

Greg Fraser

for morning, folks the material expansion, taking markets markets What GBM. part is one questions. next growth a France And important plan on generators? and of strategy Canada? become geographic is for how My first could Optune should revenue about take to beyond Good key when those you thanks where the which your are and think

Bill Doyle

Shah, is Officer, our with morning. Chief So Pritesh Commercial us this

So Pritesh?

Pritesh Shah

Great. thank for Greg, you question. that

and for in I have expansion, but in that what and on for the make that so to markets say future and is we to large but introduce globe cancer we ovarian about so to pave expansion, when So forth. grow we can we glioblastoma, our a built across continue also lung path market the Europe foundation such sure to also would particularly GBM, introduce cancer, want the think

So at that looking would think markets we not plus expect, mean look opportunities we’re EUX explore would not to you active And any if that principally you those. currently, that enter we’re to in today. market the UK, The as larger in, we’re about

the would France. mission geographies. two some to to active that then pipeline us. at other starting with which the And an for We markets our and work we we effort will fruition opportunity business, started Spain transcend in other a transcend do UK, meaningful opportunities expand our to years We’re close this effort France point that to hope ago, year from France to market bring like countries in be would into there also these for opportunity opportunities but that market into and this

Greg Fraser

of the when next then come plus data do it. What pipeline. evaluation IO sense A a you the you if when study? on will could GBM? for from questions that Got anticipate for couple readout from TTFields narrow that further steps of on out data study, the supportive down have is additional you Thanks. EF-XX? X-THE-TOP of And for development? be Can And

Bill Doyle

Yes.

Science morning. I over did announce breaking realize news results Chief Officer. And turn is heavy are research in think very today Tran’s late – we Weinberg, it So I’m fundamental our But to to going that Uri profound. we on today. the was a it’s that his published And mic JCI

on and maybe potential next Uri, you then the we if So start can there steps. comment

Uri Weinberg

Sure.

provides exploit in in publications. describe minutes independent importantly, comprehensive that key immune We better from I’ll a models. response, a very TTFields points of Tran’s had evidence the really for research application the system So take top-tier for groundbreaking could we couple it and more explanation to following increased suggests multiple Dr. and Nevertheless, TTFields patients. of that these

findings cells proteins, this Type also led, these nuclear to pro-inflammatory of the of to inflammatory cytokines of These intracellular an recruitment genetic material of clusters. complexes leading TTFields again, innate inflammasome And And production of protective deploy GBM cells, release with induce interferon response. took tumor. of large envelope this model, TTFields system which that cancer in inflammasome sensors, animal focal led basically DNA inflammasomes. and and of which are cytosolic activation part in induced are leakage a Then following of So indeed, place. micronuclei main of could immunity the activation to X the immunogenic activation, are and anticancer disruption GBM of immune pre-treatment elicit poorly

would much acting cell and are cytotoxic accompanied these Tran team so against showing also findings activation Dr. Type X They patients. same like expansion and trajectory, T see adaptive against we his So cells translated activated T the then GBM that by to clonal tumor was TTFields the the of tumor. immunity to these which cells that patients interferon in

the of or turn also that checkpoint summarize response have scientific to generate other potentially all this and to cold will that tumors TTFields other solid to of we provides susceptible treatment. and these of findings I it GBM as make therefore hot tumors to tumors TTFields more inhibitor in immune such memory the explanation words, the ability well tumors against suggest So use the aspire and antitumor immunity to

quick patience this publication in summary So thanks for of top-tier really canonical a your throughout journal. trends

another being Tran run and question, independent still his by is As study for Dr. team. that is X-THE-TOP investigator-initiated your study

anticipated I’m And in will are precise months. But additional some follow-up the take Tran to study. It his of it’s again, we another completion the period. be about And sure summarize the able unable so findings to be publication. Dr. that will

the As study, a the question about sorry, gastric gastric we about there for the or – EF-XX, cancer was the… cancer

Greg Fraser

EF-XX.

Uri Weinberg

as The previously results we yes, – announced. share so have this to year, the are study from we going this

Bill Doyle

Yes.

we already reported of at we in clinical to underline, by So the described outcomes text enthusiastic impressed Meeting the were the Neuro-Oncology with in Society and extremely Tran as November.

action is to and eagerly he’s fact to lung that able supports And Tumor that LUNAR, therapy. Fields important we’re the an Treating observation, in trials. awaiting Roche and the course, I data cancer incorporates of now the mechanism been from anti-PD-X the describe which arm partners, with leading This others. next thinking of for Merck of is wave our for potentially think, us an back about clearly terms and us input in and Of

immunotherapies, So finding. an think, the a is as to potential sensitizer or we the important has Fields Treating fact be Tumor that for sensitizer a

Greg Fraser

color. Great. Thanks the for

Operator

from Capital. comes question with Loop next Wittes Jason Our

Jason Wittes

taking thanks the Hi, for questions.

question, we immuno data on to LUNAR a a last a out will arm. have How new it does mentioned PD-X that design on two, expect tease your you thinking based how to One, able be this to as trial? signal First, impact you you do sensitivity follow-up the there? see and does

Uri Weinberg

course, patient also models TTFields either any of very showed Fields the is ones Treating of docetaxel are with publication and Tumor the also combined of context with study, immune the synergy this for the in population. Tran’s where in multiple So inhibitors, chemotherapy that encouraging LUNAR approved checkpoint

are encouraged therapy Now become that checkpoint more anticipated we of immunogenic, individual because And make efficacy the what natural the patients susceptible, aspire them exposed, setting. tumor the is immune application system is see. we vulnerable the of even before inhibitors this checkpoint more to TTFields more making the this immune ones immune more application each combination in checkpoint inhibitors and hopefully to more that concomitant cells augment immune to is inhibitors becoming could to more the than to of responsive that are

this year. see course, we’re later the of as results you Of curious to all as

Jason Wittes

on continue that you. should safety point committee then from much of comment. Or is data ovarian, significant some than out expect get is might of But to other type data Thank more monitor just maybe trial? outcome? the that there And the we going we Okay. that

Asaf Danziger

Yes.

me as we we continue guess, that our will believe to is drive planned. asked to you assumption. it This So

Bill Doyle

see from DMC. up get be the just we the thumbs not will don’t data. that We the It a Yes. data

Jason Wittes

trials looking also they specific just I pathway the And just the discussions the a even color trial full your especially been think where next-gen FDA. be you That’s to you little Okay. have I’m regulatory want get U.S.? Are terms would can might a to step. mentioned limiting you with the them know regulatory this for in more clarify that. I the be of what point? on curious if looking in then for that, add what Or for committees, they at don’t is And indication? on each related a approved arrays, to kind of

Asaf Danziger

be – incorporate improvement our a through of and the in the all will approach our trial. So to innovation way, not – the clinical

this this still that. agree is to side that our – do. way we other We basically But So is path. would historically, the neither the

Bill Doyle

thing talking And array. really I’ll either. we’re only this other add we’re not arrays, generation about next But Yes. while about array the generation the it’s excited just last

have the R&D of of exciting as talk Now we indications, a we the see pipeline pipeline about that lot product an We see if capacity, you pipeline, will. we a well. improvements and

Jason Wittes

Thank in I’ll back jump queue. you. Great.

Operator

ISI. Our Instructions] Evercore comes question with Kumar next [Operator from Vijay

Vijay Kumar

the the questions. my for Bill, thanks patient first has one on my LUNAR, opportunity slide maybe deck guys, had taking XX,XXX. U.S. patient Hey – the

in given are still you drugs, think TAM, given patients second-line have some XX,XXX IO a have or patients chemo do is the I I XX,XXX there And that is this failure. markets chemo therapy think we questions if failure. been like on,

of seeing? this talk TAM So maybe the just care about that standard we’re LUNAR, and given changing opportunity

Ashley Cordova

in I treat second from Vijay, population lung that can K non-small line we cell Great. represents is believe Yes. the line jump what treat Ashley. second cancer. the – actively is That this patient in. XX,XXX

our treatment the of post-platinum evolves, failure, so think in that that that second we’re cancer given the represents have cell design, just treatment line believe course, to I U.S. that’s So trial going seek XX,XXX we but actively second to do line ultimate potential, as line first U.S. And clearly. evaluate number. the And patients non-small we for the portion lung of are

fold size we look is an So when this opportunity potential. global at that that’s multiple the

Vijay Kumar

side your on I I XX months. X Maybe with change cancer, the look clinical Okay. survival follow-up one deck, the design here guess, non-small Phase median the LUNAR trial when for months. XX trial overall slight the was at now on being lung

from beyond XX months, XX the guess is follow-up survival months. your if I and Phase we know going X, to So be is

your just months? that survival trial maybe see So design because treatment Can a even in XX about months Phase median XX arm change talk incorporates? clearly, we and X this was the whether overall to about

Asaf Danziger

Sure.

required study, of number including set end to follow-up. is remind that of the like entire So events, the to of a the I the study, higher an at LUNAR readout it number everybody thoroughly evaluation would DMC results also the full I’d all has accrue to achieve LUNAR reviewed data of taking analysis which taken for of the from like this was point in where everybody that remind than the us making expected accumulated study, longer to time events the on the place. interim of the

the period. So in just of the last population, follow-up was analysis follow-up enrolled end that study sufficient is enough in have for the to for entire going towards the what data of period study that order need to achieve we set, the patient valid full not and a the are we

Vijay Kumar

volume assume Germany to couple from if patient basis year. points Ashley, one five. headwind may, active you. And The a Got I one. two we of of hundred last Should this

as fiscal XXXX perhaps the outlook range? low for So revenue single-digit in

Ashley Cordova

unit question. our assumption what an again, obviously a it’s believe we well. No, is excellent to as so, that’s Yes. active price which do patient tied the assumption revenue, has the And is then

should price model is recommendation look XXXX our So growth. the that at out as a QX you you

up. the I Medicare full So a that in that of includes year we do ramp administrative plus point with headwind will tailwinds Germany, but out have

think about we’re So a net-net, is at how it. think stable would I price I

Vijay Kumar

guys. you, Thank helpful. That’s

Operator

like queue in to William Doyle closing I’m turn at showing I’d back this remarks. to questions call the further no time. for

Bill Doyle

again, I thank your want So to everyone in NovoCure. for interest

as prepare readouts we’re trials. in we a tremendous launching LUNAR are and and for in and of our to next of our clinical anticipating the of XXXX, continue progress company wave the excited We our change INNOVATE

thanks So to everybody.

Operator

today’s concludes for Thank call. participating. This conference you

may disconnect. now You

NovoCure Limited (NVCR) 24 Feb 222021 Q4 Earnings call transcript