NVCR - Earnings call transcript Q3 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the NovoCure Third Quarter Earnings Conference Call. [Operator Instructions]. I would now like to hand the conference over to your speaker today, Gabrielle Fernandes, Director of Investor Relations. Please go ahead, ma'am.

Gabrielle Fernandes

Good morning, everyone, and thank you for joining us to review NovoCure's third quarter 2020 performance.

largely we team today's again management virtually. call the working are remotely, conducting With on by CFO, the Bill joined am I phone CEO, Danziger; Doyle; our Asaf and Cordova. our Ashley our Chairman, Executive and our of are the leadership Other available members Q&A. executive for also team on call clicking financial our presented be results the section of by located Relations slides link page. for our website, viewed in The the on third Investor today www.novocure.com, can on quarter XXXX Events

that materially our to I will some our statements. as filings. would are like projected beyond SEC of to number you risks a We control, do uncertainties, conference not and to Before and of in law. publicly involve by which except during we call discussions remind include in actual start, this from statements, time any forward-looking results from intend our these statements, those and time update forward-looking statements required risks could These differ including uncertainties described those

prepared turn our XXXX, in over Following With this SEC release, XX-Q, in Relations released business. XX, questions. can I press the to to of financial and Reconciliations website the accompanying materials accessed September ended remarks Doyle. line also of the our our our filed slides call in morning. now release we presentation this our X that, we and appropriate, our both measures to be Where refer included Bill non-GAAP months to and our the are financial www.novocure.com. Investor for These will financial GAAP of supplemental Form which open page Financials the today. measures press in from with for appendix the X-K available earlier X our will evaluate in are we will today, measures non-GAAP of

William Doyle

at overarching Thank on you, NovoCure. We good priorities morning, remain and X Gabby, everyone. focused

or First, patients treating diagnosed to glioblastoma established our strengthen with further mesothelioma. commercial business

the and of in indications; We progress the our Treating solid forms clinical survival across we team's quarter cancer. record and COVID-XX. aggressive another in complexities industry-wide Tumor financial across quarter by execution, all million our most our solid $X.XX Driven pipeline advance share. with of our third, despite to Fields revenue some to the delivery third delivered the multiple by uncertainty net earnings important tumor $XXX extend Second, with to in made of organization in system, prolonged improve and per posed goal performance,

the to during role, to the in equipped to position solidified Officer of date the further of in Ashley to the the resilience and engineering well instrumental of Officer capabilities our the Our actively and NovoCure's trials value Chief business record indications Wilco, of platform. our and chapter. organization. of Fields our extensive to and the promotion multiple In Chief appointment commercial, many company's of for NovoCure's clinical anticipated and growth investments August, is coming over the increasing unlocking priorities. to enables track of our demonstrates years, executive financial financial ensure team our we to few are strength performance to is Development believe priorities years. innovation to readiness the readouts and strength and working key accomplish Tumor model a testament expanded significant Frank's period with Officer. in With clinical contributions we Cordova investments created next confidence of our next from experience successes anticipated leadership instill expanded our advance newly the Financial Wilco that are company's team the Leonard Groenhuysen We an Chief organizational the Treating Ashley to innovation the long-term leadership Frank Operating of promotion

this cancers tumor of of mechanism our continue new of understanding Fields to to to upon treatment we in strategies. effects solid of Our a rationale XX translational development deepen Treating invest Tumor and years research in scientific scientific that the Building on preclinical by belief of is applicable evidence, cancer fuel compelling research. is to Tumor supported action body Treating grounded Fields broadly

radiation the therapy, pharmacological agents Fields geared combination understanding between Tumor this a alliance identify projects, indications be clinical Fields. Treating School for Fields Department Treating to Just for with Grossman is provides of Radiation use. of the to the The and in into further with Tumor NYU month, Medicine's preclinical we to entered Treating to and of conducted interaction various framework It Tumor study research and Oncology. development new strategic a studying

pipeline. We are in excited researchers. scientific working institution to with signifies with centers our Treating We believe to community Fields in research the to clinical forward academic collaborations our look survival the and partner that interest top academic with a across extend leading Shifting leading advances growing treat. cancers Tumor mission U.S. we to and NYU's aggressive

and to on of Tumor Fields safety progress indications. continue new to efficacy in generate data trials the We therapy Treating

Our enrolling III pancreatic randomized trials and cancer. lung brain metastases, ovarian cancer teams cancer, pivotal are diligently Phase in

randomized pilot survival in Tumor testing diagnosed array we launched Fields with opening study initiating which high-intensity and benefit made We system, our the progress last towards in Treating radiation of considerable to quarter. therapy Phase newly cancer concurrent II new have gastric potential a TRIDENT therapy. GBM trial, study studies ongoing post-marketing We GBM, in a recurring

We the and to enrollment prior have regulatory anticipate secured all patient TRIDENT site We conducted approvals first our United initiation States. year-end. in in necessary visit TRIDENT first for

III COVID-XX monitor cancer, in we closely Phase programs. market studies. and data uncertainty processes of unmet COVID-XX. enrollment and partnership next solid early with creating opening final XXXX. to completed for our work study July, in remain Lab, III years, first In the during data new Zai sites to focused from mark progress, tumor opening Europe, in begin sites of engagement. the environment trial, this authorities and new refine the to in a The expect to increasing needed total we in XXXX. this in seeing Phase our In we Notwithstanding with we XX indications into we first clinical on we drive ongoing research pressure third our trial dynamic the pilot organizations will and II advance Through enrollment and in the multiple with our data anticipate trial China potential expect by trials trial beginning contract the a continue of needs. stabilization we multiple institutions, quarter, trials, are few HEPANOVA some the significant clinical added expansion signs additional liver U.S. of environment geographies site of sites across certain high trial clinical of In in clinical and persisting We despite our to HEPANOVA research local our the Phase as to quarter the caused readouts

software we our Beyond development Officer, Treating Leonard capabilities to Tumor including to ease Frank to and to our teams development innovation is as innovations Development overall improve our NovoCure's continue Under evidence operational the new his use, Tumor Treating Chief programs application. of product's programs, development. leading business In technology product Fields strategic with dedicated transducer and strengthened our applications. Frank, our expand have deliver of charged Fields guided generators, efficacy arrays clinical intended development platform, innovation of with and optimal role therapy's and we scientific by

initial Treating of energy newly patient's is our last we therapy, planning diagnosed to development of region survival software applications team received Guided higher quarter, essential a Tumor an doses completed process tumor. patients Fields to planning treatment in radiation package Maxpoint. of GBM the who that with optimize software Treating therapy, delivered As by demonstrated the treatment research Fields Tumor new call improved a

of of evolution, on partners. NovoCure, to and to therapy's are and join and Treating with in select We Fields early highlight we the the lives continues virtual in patients are confidence you priorities Day our for programs they our a invite to R&D are at We potential XX. difference a us central to We of in build. believe a have commenced radiation beta the of make testing November oncology stages cancer our of Tumor as development Maxpoint we progress. Research number excited

During I'll research. and our of to the the session, over Asaf on to to areas plan in internal review that, call focus perspective translational development third quarter. we the pipeline his and progress turn share With highlight external

Asaf?

Asaf Danziger

NovoCure million in The $XXX another a strong net up Bill. global team you, delivered in Thank performance versus record reported We QX the XX% quarter. revenues, third XXXX.

on Our patient XX,XXX X,XXX patients patient Optune. net to insight new GBM. GBM. represents revenue patterns active our growth to the data the active quarter-over-quarter the at since active primarily into end than with in treatment COVID-XX, by continue therapy and growth more driven gain adding of to for we was patients of consecutive This XXrd growth grew reimbursement the quarter presentation care date EF-XX of our expanding of X% QX, treated diagnosed of patient months X newly globally. in into Active

the As treat past, aggressive COVID we XX. noted in not do slow cancers the with

the seen date have and us adapt fluctuations and our we focus therapy this prescription quarter in adapt business. year, minimal on our to momentum to Despite care flow. health patients providers highlights these to to our and to proven we had with enables of how and regions, We sustained patients continued certain in disruption and in have believe virtual serve innovation the the to situation dynamic surgeries ebbs adding XXXX Optune programs. in Throughout that We and commercial ability partners. with execution to radiation timing our team's some capabilities in influence which third interact commitment our remain flows, we by and confident

also impact on commercial to To technology Optune a for capabilities to peer-to-peer created care without increased scaling multiple business of highlight Lua. patient's unique For we virtual these COVID-XX that our serve and developed The the engagement for engagement minimize patients download providers, engagement We allows believe the health with future. the we rolled need foundation download remote a visit. of business. benefits in-person helped us an example, Optune many and in more we provide programming new data out our innovations to from the have our to maintain tools device

actively mentioned, in Bill future on working organizational of are anticipation readiness growth. we As

in We and additional are our to Switzerland. market footprint into Sweden markets. strengthening Israel, GBM currently we approved commercial for expanding Germany, Austria, indications our Optune EMEA, access In by

believe exception plan for of Optune reimbursement with the a have submit French national Federal to full Ministry have continue reimbursement Health where our of the GBM secured all and to pathway in of We ongoing the Switzerland, coverage we we in a coverage Health. with France identified to in to package establish of markets, discussions the Public productive in GBM active Office to We have upcoming reimbursement quarters. EMEA Optune in for nearly

indications. enter markets access future to evaluating prior indications the We marketed pathways major market launch currently additional expected European are our for to of

believe gain treatment to know continue we amount valuable market GBM, effort of of proud experience I GBM, all NovoCure MPM the with how currently I beyond colleagues. MPM. quarter early Based we these efforts providers. insights extend this health the of to in will the a beyond educate on significant that technology performance acceptance a benefit want a Moving in testament future new our to patients development. care about and commitment landscape we of requires year, indication And reiterate torso to and of am our this that to

I colleagues financial in discuss the listening With to you thank that to over our call our that, call mission. turn on patient results. today, of you forward those support for For the Ashley all do will

Ashley Cordova

flow continue in financial a we the reported Thank record year-over-year share drive and of generated see further sustained delivered per third earnings the to growth. $XX quarter XX% disciplined We you, from Asaf. position million revenue $X.XX as NovoCure cash growth, revenue team in execution operations. its in our strengthened

and of a efforts our we of to million revolving profitability along growth We enabled cost. anticipated financial the improved profile, years. to for long-term carrying with new year ended over at process us growth, repayment in capital significant structure of with a few the implementing, solidify quarter the $XXX a next positions long-term with are foundation sustainable period cash and The $XXX are debt, secured in three addition In lower the credit our innovation facility well million our significantly for our strength we a which cash equivalents. replacing

Turning to our quarterly performance.

of revenues $XXX growth Our QX versus XXXX. delivered quarter GBM XX% third representing million, business

We net net growth in well quarter with active revenue an durable as a million the active year-over-year Lab. in revenues from under as recorded per and driven collaboration revenues our GBM. booked in coverage from Our improvement increase was patient positive fee-for-service growth newly policy patient $XX partnership Zai for billed beneficiaries revenues Medicare diagnosed the by third

beneficiaries. compared timely ensure have to Medicare contribution the of expected have processing a QX, we how sufficient of recognize year, understanding X/X last the for Over first good gained of Medicare claims in to to X $X resulting net also approximately coverage. XXXX fee-for-service In quarters claims experience to revenues of we and approximately of previously built appeal the prior incremental million Medicare denied recognized beneficiaries successful established from the for

profit P&L. and benefit Gross $XXX million, reflecting gross margin initiatives down the continues increasing the in margin. quarter Moving third a Gross efficiency from ongoing scale. to XX% was

and priorities Our support of part quarter, up to continue and R&D the capital trials, value personnel to Tumor pivotal an XX% science trial development in medical investments research We and affairs to of our expansion our a increase activities. of advancement XXXX. invest $XX in in primarily continued the was unchanged, innovation of and development Fields are personnel versus and our and program, Treating in invested the for increased expenses the we third support III increase strategy. our allocation technology product in long-term million in an expenses clinical Phase This third post-marketing creation to quarter preclinical as due

We and Treating development product Fields expect increase programs future across and as acceptance continue in expenses quarters to of to efforts scientific preclinical, the we R&D increase global our Tumor advance community. clinical our will

revenue disciplined growth. expenses SG&A growth organizational commitment XX% Our of XXXX. approach MPM future In in XX% parallel, third we anticipation support as efforts achieved GBM versus quarter third growth, to the of to million, and commercial year-over-year in were $XX a we readiness maintain ongoing an and spending reflecting up quarter

was with million profitability. Our earnings $X.XX net consecutive in representing fifth quarter our share, per of $X income

million rate operating important attributable reflects was this capital driven our for expenses. metric our of and by based XX% top believe period million increased the earnings of amortization evaluate our in it the the management value the improvement same specifically In measure to growth fundamental disciplined also adjusted generated a impact non-GAAP is compensation, from items, to noncash financial it performance performance as We and before the and tax material in taxes, interest, third by compensation. $XX on best EBITDA, of EBITDA adjusted depreciation, removes structure, earnings financial business. quarter, This We an XXXX. by share-based by and share-based $XX line

the Before call in phone over Q&A, I I their like operator continued interest hand everyone to for would for NovoCure. the the thank to on

our to quarter value. well of sustain record in are We delivered the Our believe our the team, strategy growth team's clinical and financial invest maximize of and forms some development fundamental of and product execution efforts the of organizational potential our us track the remain of that aggressive survival Tumor the long-term strong another performance, programs to shareholder Fields prospects readiness positioning advancement extend in cancer. to of designed strong, we in our in Treating platform of long-term and most business confident and

Operator

Instructions]. [Operator

Jason from question Bednar with comes first Sandler. Our Piper

William Doyle

Jason, don't you. we hear

Jason Bednar

Bill. there, the there. with quarter progress. trial nice start your just I'm mute sorry, on was on sorry, I to I maybe really Congrats wanted

are COVID. your partners has to globe. going appreciate, seeing be you're ball maybe what just great you're year respect here a into think enrollment trial earlier as we and outbreaks you're center today this could the to we with when it'd to grow you And with able curious research if across speak But contrast onboarding really with crystal site all if we're countries real-time saw hearing what the and I from that lockdown? seeing seeing nobody

William Doyle

Sure.

remind in by where management I'm the of different depending first world. all, good team, Ashley parts on Asaf, but and we're afternoon, you are. hello, So everybody the all joined I'll just of today morning, -- evening, and

challenges this to all flow have regions in bit question. and regions. There's this as Ely, able just to the NovoCure question. to of MC the going that, commercial turn time. going unprecedented to maintain difficulties But our specifically clear -- patients you in congratulate, word, on to our different the morning right different And maybe the of it's on the can to and comment want specifically I'm the this you patients ebb act the Ely our I'm because clinical an comment the we but with do care serve. the in little So that that spite that's over patient different trial a question, been on I is that team teams if

Ely Benaim

Thank your you, Jason your for -- call question.

for anticipated in Just to to we -- data that of supplement our things I clinical our what Bill from done, ongoing of what that we we has updated timing one have trials want the is QX. unchanged is say first the

trial treat to continue current We patients.

trials. to patients geographies. and certain -- On this new we in started COVID-XX, environment early in clinical you of stopped as clinical enrolled volatile. early stabilizations stabilization So haven't the know, is the signs in have that, some trial we see But we

the opens -- area, are you these prepared in but the assure one to each And clinical I once being closes So keep of trials. -- others. one in in we pushing can geographies one that are we

the clinical company, So situation. pipeline monitoring I the COVID-XX that we would the our priorities advancing continuing is among in say highest are and

Jason Bednar

then where think of impressive. know, All recruitment And future? That's mean patient second, past. it for onboarding, III partnerships does accelerate similar there with sites the any it's is the helped and specifically, efforts on that the and ovarian got been study to on. influence most mean focus is kind seems the I your going recurrent there And done now what that you've on that past, you've that onboarding has the of trial of line development Great. site the you studies. maybe in how the I trial But in to Bill, there are you've right. the I kind like about part, on time partnership trial cancer. recruitment, point of in trial helpful. INNOVATE talked this Phase I in this the mean in the real the site a I

William Doyle

Yes.

absolutely. So

trials said, Asaf something absolutely We that see seen to absolutely in the our clinical among company. these may and ensuring entire we you're the applicable I apply trial another. the the in And Ely is one is while management and cancer the right. And the principal in progressing various how completion those engaged As the were and learned be responsibility, highest other Ely has priorities And trials. to successes the trial, of trials. in looking it team ovarian in we've successful

Jason Bednar

quarter, the Congrats on guys. nice

William Doyle

you. Thank

Operator

comes question Fargo. with Larry next from Wells Our Biegelsen

Lawrence Biegelsen

One NYU on China, one on the collaboration.

And So seen you've in and good ask doing Could collaboration, Kong upfront. just studies? we treated about forward? provide there. China in any color, think Hong China, what Bill, mainland China, Any uptake can some very I'll question color you you the focus be the pricing? additional do And talk the there? NYU when might versus Zai will start commercial on you patients second in Lab's additional on about reimbursement the how going rollout

William Doyle

Sure. Yes.

first be partnership teams a lot that's I great Zai Chinese any to example to a Zai have So collaborate a of sort market, with way textbook to of this partnership the company been with teams our at the uncertainty, But It's Lab. respect course, And we the the with China, of lot been couldn't that market. enter think more of China pleased able entering Lab. there's wonderful we all, of unknowns. with have first for a of

has principal progress Zai, the that, for with Now responsibility in China. reporting course, of the

to but were of students in learned our numbers, have the what on we launch. rest and we world. the great been pleased had very going the not of support have adopted model the comment So I'm patient They with

in to see worked specialists as beginning in pricing early When therapy do use. the our you, can global and China. patients we and have self-pay. be effectively growth a effectively to also work remind support would we in model have largely again, now, you the numbers, Kong they appropriate them strategy. So Hong launched, bring I'll train extremely is the extremely that anticipated device And That we has in that

then insurance China the was special why long is not is the the one of become enter good for in Zai I are clearly strategy on we in we determined part forefront insurance pricing because seeing the were China. that, say and China. new of also reasons so to models coming the saw in of models emerging This the would would patients the mix which that the there. market that in We're China. is evolve term, payment will So

opening with clinical partner and Chinese year. our we're of wanted to I'd therapies of front, our organization, GBM extremely anticipate patients to Chinese hopefully to great early Zai mentioned and we say our And into trial I'll global we commercialize centers remarks, with soon we on join chose and them of in partner we work pool So bring the global leading in thought in And all, MPM sites for the thing trials. footprint that note, made, pleased. that will clinical course, all they to we our a final the this next great our access be would trials. large also And because but we part progress Ely's our in a China, provides as leading this

progress. great So

with respect a Officer. NYU Science Dr. the to by And give NYU, Weinberg, Now of our you joined Uri can maybe Chief on are comments partnership. Uri, couple Weinberg, we

Uri Weinberg

good morning. and Hello, everybody, Absolutely.

-- alliance alliance happy in believe studying community, projects preclinical across growing signify expand research institute look well the look that centers. sorry, in this very new a to The through academic radiation results excited partnering and provide strategic And combinations, these TTFields forward clinical a Treating our conducted we the identifying the light to topics sharing to of leading like We're TTFields as we additional NYU. projects scientific and I'm forward going research of future. more interest be on of partnership to therapy, also to that for development for designed TTFields this new research indications use TTFields. very the with such is to collaborations academic about encompass So going U.S. is combination with as is as Fields. to this as part with framework studying in shed Tumor going for This

William Doyle

Thanks, Uri.

Operator

Our next comes question Evercore. with Vijay from Kumar

Vijay Kumar

to I trends Congrats growth at Street you really look solid a But question revenues, on environment, is, on frontier. my Bill, you impressive. XX% close a when guess, pandemic active at growing in year-to-date sub-XX% patients, And healthy of, been I numbers a for modeling growth. revenue we revenue at next at it's look part Street's the clip. look pretty the year, dynamics, guess,

So can we we you this maybe active the XXXX? plus to just patients XX%? a on is of at that sustaining expect that comment medium that And key driver Is something term? could grow for when look revenue growth

William Doyle

Sure. I'm going comment he's to over field little bit in to and Pritesh in to question follow then the patients, about what seeing turn this a I'll active up.

Pritesh Shah

What dose Bill. patient we goal -- optimize you, the good thank support our is that what Thank has a built to on the can relationship. education regards you is time dose-response leads support model. to of our treatment. response our that I we to for we and know through have would morning Vijay. Optune ensure are and Good sure And We benefiting model patient Great. is with that question, in good What with start outcome. to that because follow patients make everyone, relationship

we making system, so our that primarily this sure what doing date support our is have been to is So DSSs. patient

provide patients, frequently. support, enhanced touching support learn on first this initiate the ensure they is understand with and we our those treatment, patients them experience to for with we can As treatment, them for we best from more month base early they're that look on how

called we Just MyLink. tool a launched recently,

track earnings happening opening because we the the that time. may important talked in be that on the about the an this treatment usage to innovation remarks, This heard is anything call. this, and real able You with now we're last about on time

number patient use this, this to education, if to now prescription active are were therapy. that we available our dose-response efforts lead sure patients with see we our XX% to are strength the newly quarter parameters tools can that we continue in again, X these all in any we mix, prescriptions this with that So saw make in newly horizon. of And that newly live now couple we optimize the of total our greater continued diagnosed, diagnosed given that relationship

William Doyle

Thank Pritesh. you,

Vijay Kumar

follow maybe that, one up Ashley. Ashley. guess I on for To

in that that perhaps here sense up think prior for, years? for a look from are Does payments. claims One, is, your catch sub-XX%. you Street with to this -- -- If are? for make about And when comfortable Or filed numbers modeling was number we at this revenues you half? in CMS, extent? I Is revenues of where bits deceleration prior where the Street be was you expecting go 'XX against to XX% decelerate it that onetime trying of should first success like, payments that with catch-up successful guess I'm because perhaps this future to denials? to

William Doyle

just So Ashley I everyone. -- want for

the We financial in of welcome call all more to want couldn't Cordova, to operations pleased her first NovoCure. Ashley to I the company new know place You her but of earnings her in her role hands. be CFO as

Ashley, that, with So please.

Ashley Cordova

thanks over To still Vijay, to activation do book for question. an and opportunity time. the increase Bill, we revenues answer net thanks, the there's directly, Well, for think

with that reimbursement. that Medicare, revenue ongoing there growth So increasing both improvements globally our is just operations Pritesh clearly, beyond the revenue drive net through to active to patient but an with opportunity, in still alluded growth earlier,

coverage next don't that guide, approximately we XXXX. know, booking fact you alluded specifically Medicare so can't I As established currently our from the we year, speak X, X/X of we're to September to benefit but have the

the earlier reimbursement With claim as So we the year to received continue of the as being Israel patient the backlog go full that a in in about reimbursement well received we future receive establish We've $X this to of That there. working to authorities still discussions We're from have drive incremental third claims reimbursement. September in population. benefit was appeal hopefully in ways important with out the here. talked still that ongoing successful the we will always incremental XXXX. to for of to prior billed regards payment there to the the quarter, million X, result that of denied Switzerland

this. reason. predict appeal a not them a these them. taking rhyme We're a is from to or walking There are treated This very We does we have through process. ability patients. But not have long-dated away no

these as to not we're simply can claims, book future, walking like to Again, from will tell it's We and of revenue. what but we appeals. and we on receive everything make soon I continue those the are we pace back cash can that of the sure to as too away doing revenue you comment the in looks that we that realize cadence to

Vijay Kumar

Ashley, is way my if guess for... I be prior any I I claims add for to didn't well. helpful, as extremely there That's would size backlog is opportunity the remiss congratulations what

Ashley Cordova

the patient we those not. in of mean have one said we of fighting Unfortunately, beneficiaries launch. that active can. every And what -- time XX% I have Medicare are population since beginning, claims U.S. to patient been XX% again, active our the we that from

Operator

Our Greg comes from with question Truist. Gilbert next

Gregory Gilbert

pipeline A couple ones. of

it a move terms First year in phase, What speed next on that for next let you've like that been to do what frame if HEPANOVA, on the more just know you of data. us warranted? with can looks event granular you could being QX to and versus us

William Doyle

Bill. Greg, this is

we the that we pass to always know timing better data available, when the the think as and on, and we readouts we update HEPANOVA now feel predict that closer readout. we I can we've of said, will get be and can

our -- patients think to very we've therapy can to get I always been is that goal overall benefit. our who

III the be to would we get trial. as and move Phase will so deliberately a which to stage, as quickly next And clearly possible

So a protocol while written. to it takes a get

and immediately the but already would move lined into up, the about of get centers next we to process we're that course, steps. Of thinking

Gregory Gilbert

by it Great. start that And that very you the delayed I strategy." XX-Q, Was of bit? you in like signed little on the Merck Maybe was "modification a then has that that the collaboration. pilot intrigued Can you your flesh and summer But to share? collaboration to the their encouraged that. looks background a any study out moving change? in other been the due regulatory can it Merck change, on last

William Doyle

Yes.

we that of on So types specifics in of important to very that quarter. And going this to interested pass the maybe work did the we collaboration. are This think Ely I a I'm of with clearly to is partners. conducting over it's a regulatory collaborations the company comment during first pharmaceutical the

collaboration Merck collaboration which Big collaboration Ely, the with a any on is of great prototype work comments the academic for the during Pharma. institutions. with quarter? saw a is NYU, You partnership The prototype with

Ely Benaim

collaboration. want align Greg, thank all We sure want this we that need things just FDA. up. to We're anything. make your make to excited we lined about really And with sure I have the that delayed we for really haven't sure call. you our we that make But to

before having So FDA and the regulatory of year to design. with conversations confirm end our the we're the strategy

the next of in So that's them half first begin year. to why we expect

Gregory Gilbert

just or see other that I trials? to Merck that, lung the you to data want nothing with do agency the has from setting confirm or in more wanting to

Ely Benaim

we haven't. No,

basically with there, It's then on. the about do to having all nothing move we'll from it. has that So talk and FDA to

nothing development there's or of So this stopping delaying the program.

William Doyle

Yes.

underline. to are... Just These

Asaf Danziger

Yes. add, I to do want Asaf. it's

and Merck are the I process so regulatory us think agencies is it's extremely changed -- nothing for far. the with the And Merck and collaboration happy important on of us. in and together we it, the response the and part that all working time very is collaboration from our line, are this with

William Doyle

Yes.

FDA to stuff. These this affected with the FDA just the by a COVID, course bit all trial. but course the are normal Greg, discussions a interactions are So little the underline. is in The normal upon serving with

Gregory Gilbert

Okay.

in goal about on. technology that But it wording. curious if those allow is or information? it? mix But strategy set Or the here Sorry, I queue regulatory the question, a Last session one-o'-one to by things? Or I'm modification off to. expectations, if provide about to thrown the I'll those had R&D Day. is sort I'll want you for was and Bill, not the move a you the it more a backgrounder forum of is new of it may understand is of a more to provide have on language

William Doyle

Yes.

is So the one-o'-one. not a primary focus

fact of of us have community ability development It's see Tumor very We expansion who a expand We collaborators performing the of very and of a of been the research are tremendous for those Fields. things on of the been the that's with our in independent gratifying to years project involved the this our well and financial think as to important clinical of and XX activities are that scientists as community. quite development to result our literally this published one development to is performing, efforts notwithstanding now amount has internal and Treating the that financial are papers in visible -- development and don't community, our have a the lot been research projects work to been strength. that hundreds and understanding as our

some a It's meant useful for in to and important will we build that of think be very the a distillation our work the be community. of the use confidence So really to to it's not field financial be I one-o'-one. meant

Gregory Gilbert

about have to one I in, it is And all sneak oncology?

William Doyle

You'll come and have to see.

Operator

question Our Northland. Jason from next Wittes comes with

Jason Wittes

Great.

Some follow-ups here.

at that million be And indication have it? be other there catch more of on know assume in that don't could petitioned? petitions on queue there's the off, come -- -- might up. $X some Or provide some color First that may I if just is on you you any when they I terms to quarter more had? is the timing

William Doyle

but this your can Yes, maybe Ashley, Ashley before, you mentioned underline comments.

Ashley Cordova

Yes.

I'll Medicare that business, began been revenue which the XX% population patient normal course remind for of received coverage since the again we everybody we we in U.S. So And to of recognize to our in September has XX% XXXX. launched. just

is to So $X to a there backlog This certainly backlog, ability but correlates of claims. that time. pace no those of have receipt the million prior we that to predict

any of before, we them. from away walking mentioned not I are As

actively and revenue are we claims them, can receive appeals for long-dated that So to and we extremely unpredictable we process everything backlog, through but ensure is do process. it these detailed take an doing

more the we as in future. share can So we'll

Jason Wittes

NYU the think at radiation on announcement, it in of That's main looking of we they how do focused one helpful. appears become How I on about the are it then might it with that? of conjunction to work in may And oncologists. Or mean dosing? radiation is Okay. terms TTF? be prescribers you

William Doyle

Yes.

question you with of radiation can oncology this relationship some with the great start our -- think partnership. maybe both of for and Pritesh, is can working specifically the I you Uri. Pritesh So about goals early a the maybe community. talk And the Uri,

Pritesh Shah

our many I mesothelioma. in built where that diseases that other business and Sure. specialties the both we in for on of question. key those and diseases role. What we is comment GBM of Thank a you investigating play how the some diseases our we multidisciplinary What is are realize would

experience remarks, the of Bill to with of Our of very how well those on delivering in mechanism referred it, that community it treatment. action Fields, delivery the the based radiation that lend themselves aspect Tumor specifically oncologists things Treating and oncology how the all his think oncologists radiation aspect dosing the radiation to of is about

is So how akin aspect to of many aspects the are our radiation radiation delivered. regional therapy delivery, planning,

So see because with radiation in We a see in the that, is great of that see space glioblastoma, glioblastoma deal the with the TRIDENT in We study oncology interest that combining of our space. and mesothelioma community. particularly radiation. we with which

lead front. of specific for Uri So over on this in ensuring the on we then particular continue relationship, to today and space clinical important on to that comments going you particular decision-making it, evidence I'm And NYU the this the that. to us to commitment this partner both as future comment specifics will to about think we I'll well build to turn as Uri, of be group our might ask collaboration. what it to treatment lab to continue as the evidence, an to our also which is

Uri Weinberg

Thank you, Pritesh.

modality, the the going conducted involved a well oncologists in as already as intent is alliance. been the this to are say part this comes rationale in this since of their the primarily preclinical be we physicians this and TTFields and naturally be to anticipate led agreement. this that there the the new in between studies it definitely for of at research be prescribing scientific would TTFields perspective, the and radiation, become to to from there's collaboration in involved X the the synergy in who preclinical as radiation. clinical have and When way. that been very of strong NYU side. I involved of and oncologists the of TTFields other Nevertheless, have overall as a more we working different departments And aspects modality. treatments, part has happened discussing with research This Nevertheless, other significant the So collaboration from seen by with population departments combining radiation evidence a more

Jason Wittes

last Okay. was That One question. helpful.

Just glioblastoma. but in you bit on little studying ahead. not a -- until XXXX, It's are it's high-intensity arrays

works but indications. would also regulatory other up it to a the would ends be Assuming that going for is it assumption I work glioblastoma also be trial, think positive to for probably that GBM, what the if be pathway for

on to thought if rerun So or to there's have I'm guys Phase about have curious high-intensity pathway IIIs you the you whether shorter getting if market? a

William Doyle

Sure.

our with other bit We the dose we terms new and as what And And this the the With able There intensity on strategy. approaches our the regulatory regulatory to Fields, multiple the patients to talk that and that. of mentioned earlier, about of of little Pritesh is of absolute intensity financial technology. course, may that doing we're the stages as to specific region. encouraging, on also and can terms the be sorts our increase remarks, core about an very focused early actively deliver to we've of we therapy. will on today, think array of strength, But have Tumor determined of in a talked one the and it. in in priorities. dose engaged We're use, in strategy, respect dose in prior It really it's obviously involved patient our investments maximum discussed as our with patients previous of we're of we deliver. depend technology, can a our to ease big that in we design. response fields little ensure to in So see early as improving the reasons. driver in is both mentioned things time by calls, for Pritesh Treating is with which all principally we're the we're comfort

we to would claims innovations that these would order wouldn't I longer wait patients. early Our may be to to They improvements goal in have But to as for clearly to -- patients expect to in specific by trials followed get make those as trials about extension. life need bring be these to in possible. order

Operator

[Operator Instructions].

from Difei with comes Our Yang Securities. next question Mizuho

Difei Yang

One So one mesothelioma questions. two related. on finance I and have is

Lua a shorter a share set fit therapy the see how plus now approved Yervoy mesothelioma, was mesothelioma CMS first-line and will reimburse paradigm, the that may reimbursement. pathway you think So we for would of as thoughts indication, getting the on do be you into Optune treatment evolving for precedent on there GBM, because -- for your that Opdivo by

William Doyle

on with to start a may me and reimbursement. ask Pritesh want to let comment on comment follow-up MPM, you So to then Ashley,

Pritesh Shah

for Great. you Thank this question.

from our on patient making and and safety that sure that. possible. both our -- profile all And patients the we are moving with there the of the now histologies. forward Lua, still can of from a are as as MPM for Optune view that treatment are efforts educational profile across Lua many on that, of IO focused The are is significant well for relevant dual need making populations this win efficacy and that suffering we mesothelioma, as combination the that said patients physician patients introduction for disease. for we unmet believe our therapy Optune patients who benefit right remain all populations Given Having our

I think now, this doors further studies. for introduction up opens it with

cancer potential investigator-sponsored studying been And of many that in of IOs, continue Lua then So to the setting with our allow studies other will types this in TTFields be with non-small lung cell combinations. combinations evaluating with LUNAR we Optune studies also, and this exploring has study. bridging in us our different on strategy benefit

Ashley Cordova

third Everything that, for or revenue we'll be anticipate I access too timing second work time certainly of gain with go the to private quicker. just to question. Similar easier, to it material upon follow-up first a point of then on next hit But soon process Medicare. begin year. a Perfect. GBM, is at with would simply around. point your conclusion payers would a it's to this little And we through and towards reimbursement

Difei Yang

So reduced question reimbursements and claims, Of book whether your at us it to CMS these you finance. were able previously backlog related Are I'll you you as $X million. rate? are my denied current Medicare just or able those ask so rate second reimbursement, to at to is tell same the

Ashley Cordova

we I'm coverage provide LCD be X, price to we're going can somewhat that negotiation then we're through. benchmark not than we we of effective to say relevant and I out we as there But is much X. claims provide the them, information as list tell as And through case go But ongoing appeals. invoices, Again, population. for in for billed and other to any it our able detail prior that that bill an September goes the is to continue Yes. to to and -- as dependent place going get we be work are additional post level to working still because we claims as that those of it patient is put the able e-schedule you not at will September

Operator

further back any Bill any for showing questions at to remarks. over this Doyle call further like not would the I'm to turn time. And I now

William Doyle

priorities. So for three all, participating you to first call. I'd our like on of again has earnings all overarching thank NovoCure

from working benefit quite them. simple. to our who Our all strategy patients globally can is are the to that therapies approved extend We're

R&D But I patients of team to trials deliver our difficulties early trials, NovoCure in to expand improve clearly what difficult want our they're therapy of These that we're platform, the continuing news we to all the times. Treating to the the which is deliver to demonstrate applicable Secondly, recruit improved with to and they're of for treat we're can that ability working to cancers ability efficacy volatile. -- are these believe expand our notwithstanding to see we broadly our continuing notwithstanding all patient patients, to our treat difficulties We our Tumor action. these new stages clinical delivery working thank and the both open we to mechanism of And benefits comfort. complex difficult, in to efforts. our and third, they're to think be to and very Fields

Thank dedication these see their And we'll really with have and next for So that, their you. team to you the times. thank quarter. I again hard work during

Operator

for Thank concludes call. conference you. participating. Ladies today's you Thank and gentlemen, this

now You disconnect. may

NovoCure Limited (NVCR) 29 Oct 202020 Q3 Earnings call transcript