NVCR - Earnings call transcript Q1 2021

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Operator

Good day and thank you for standing by. Welcome to the NovoCure’s First Quarter 2021 Earnings Conference. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker today, Adam Daney.

Adam Daney

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

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

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

William Doyle

good everyone. Thank and you, Adam morning

are pleased today. our to first share results quarter We

made Tumor Treating our programs Fields progress several Over clinical we across development use. optimal the last months, to determine

invest to in generate needed the our business financial to strength commercial established continued Our future.

Fields ahead, potential As to levers the look platform. believe we multiple remain unlocked Treating full we Tumor the of

generated $XXX have in $XX the commercial tumor in with milestones Fields. programs of patients treated Treating in solid to reached recently continue in to exciting clinical patients Our in and invested Tumor been XX,XXX We development research programs we intended XXXX trials growth. and several million fuel revenue million seven net across future cancers. actively quarter business enroll Almost first and six

road unethical Phase expected in data other interim Earlier non-small for or possibly increased continued to was we than accrual, As just on futility the unnecessary accrual the clinically evidence a monitoring X toxicity ahead, we presented recommendation our successfully patients cancer the There from are date on the to DMC of XXX month, reflect progress relevant arm. low-grade concluded proposed to likely independent and no and analysis data LUNAR as toxicity believe The control. the rate this of given is experimental for current original pivotal hurdle. say trial DMC accrual our favorable prespecified clearing randomized in patients the protocol, committee with that went the that the it skin beginning. to we lung interim generally in and we continue announced cell to

patients potentially amended IV last trial. providing efficacy the generate cancer follow-up blind their data or and toxicity non-small adequate first believes metastatic access the therapy. recommended progressed, LUNAR checkpoint alone trial of and line Israel, versus who cell has Treating docetaxel of data inhibitors arms checkpoint Fields both testing designed within the failure. docetaxel is cancer and XXX blinded the is study DMC XX-month effectiveness NovoCure the well a efficacy important following reason, Tumor lung enrollment platinum LUNAR multiple patients as cell Europe and this a full this immune remain the with through non-small meaningful Advanced the in treatment data inhibitors after cell DMC of expects sufficient was sites with protocol from with trial trial platinum-based overall or during following subgroups. patient. the For information an Western commonly power to when recommendations. completion that making fully non-small provide The would data multinational lung to approximately and trial to clinically to the therapy to Eastern or adjustment regarding outcomes patients treated as DMC the in with contemplate together of platinum-based accrual the stage States, immune safety providing or is for of United regarding with for lung cancer The and

of We signal the the of potential reduced by the date. trial strength size with power are and very DMC’s the excited maturity sample the and data generated believe of follow-up recommendations endpoints the all duration is indication to to an and

submitted an which to recommended IDE the XX-day and following final awaiting protocol determination incorporates have We review the the agency’s a supplement period. are FDA adjustments

to [ph]. and the recommendation to engaging Fields. approved, Tumor that cell stress, Tumor enrollment. milestone benefits Treating Fields Tumor accelerate understand Treating in cellular new can efforts levels triphosphate with are The year. in together trial If [indiscernible] our deaths. with our action of research development Treating Group an potential reductions opportunities We markers also better our a lung Multiple Tumor of treated the Treating the by Preclinical induce benzene presence with our in represents than Fields identify mechanism when trial program, protocol [ph] exhibit has BX of also secretion our the DMC cancer dependent could exposure Fields of calreticulin Cells more and in high shown completion mobility significantly investigators immunogenic specifically used immunotherapies. to accelerate important increased

and anti-tumor in tumor observations animal vivo. enhanced Tumor vitro models. control in reproduced increased anti-PD-X immunity Our resulted been with together in Fields therapy have in Treating

dendritic of therapy The anti-PD-X Fields We alone have suggesting Treating Fields with mice higher tumors tumors increased treated macrophages Tumor and tumors levels in and with Tumor in treated in Treating in response. Tumor treated inflammatory Treating Compared with anti-PD-X controlled therapies. PDL-X in untreated mice. mice observed alone, a Fields to significantly an and expression cells elevated frequency

this to eager to clinical translate are preclinical data. experience We

Treating addition the and together with We to treating therapy Combination to therapy first-line immunotherapy. KYENOTE-BXX provide the concomitant Fields and Tumor cancer insight and our trials Treating KEYNOTE-BXX with our KEYNOTE-BXX the cornerstone of designed Fields other LUNAR of IDE into valuable therapy In developing non-small benefits pilot Merck. will potential which cancer standard Phase emerging trial, limited are care received a to initiate cell backbone pembrolizumab treatments we've our upon collaboration lung added. recently is care trademark Tumor Treating LUNAR in generated from of cancer believe can as is conducted toxicity study Tumor Fields with data X of in cancer. with be approval trial MST, we

immunotherapy, a Treating continue benefits with we Treating and In Tumor Fields radiation the liver in explore using Fields investigating therapy HEPANOVA recently with with addition sorafenib advanced of together potential XX kinase patients certain trial inhibitor Tumor together to concluded We to cancer. our chemotherapies.

presentation June to I Asaf results will discussing the call quarter. commercial forward at for with and submitted investigators turn discuss over data set upcoming and for investors full to now the in the future. a to look have clinicians, an We medical our abstract the conference late in

Asaf Danziger

Thank you, Bill.

net Our quarter QX in This revenues versus XXXX QX active patient months increase an first XXXX. XXXX year-end. We XX% execution of patients an ended This team X% the revenues XX% of and an XXXX versus therapy, on of growth. XXth in represents quarter our XX% of quarter with XXXX. with margin. versus consecutive delivered active net $XXX another consistent represents the Global million three totaled gross increase of

raise durability We through postponement we We GBM have the are as with seen of pandemic the disruptions the U.S. Bristol-Myers of the past the healthcare ability Last have to believe the this In has some by can engage providers our COVID-XX patient’s posed by postponing with the person to in care a of Germany In business cancers campaign month, due to of of to cure. healthcare nationwide of dangers patterns with consultations allow providers. increased we point a in-person Yeswecan-cer especially the to awareness challenges in we encouraged caused the pandemic. increased health treat, supported aggressive by patients care sometimes to begin risk year. delay in our disease Squibb. launch together progress the the

are of and establish opportunities the to awaiting Optune are vaccines that there the full factor French drive continued distribution we between of and We will subsequent year, reimbursement Last We providers patients continued healthcare this alleviate going normalization Ministry the reimbursement for to Optune believe multiple guidance the adoption. submitted from to are Health of forward. ministry. activity package and hopeful

expand to access to evaluate are indications new France, we addition in proved to our in In continuing opportunities markets.

geographical several further Optune are centers in a opportunity we the significant the adoption. Germany, to Beyond representing and underpenetrated expand our opportunity presence, increase at key to U.S. academic

As the and in Optune a confidence diagnosed long-term GBM. immunotherapy, for requires drive significant surgery, chemotherapy to even lesson treatment increase educational enhance best in compared the to and belief chance survival to newly radiation, modality awareness effort therapy, and as

leading and therapy with adoption. cancer broaden further engaging actively are to We our awareness institutions of their

TTFields study researchers in our We launched academic key are at to with at the engagement months, opinion clinical treatment increase leaders. recent also addition to the our University, stereotactic to efficacy for of and determine centers presence a of GBM. leading working In radiosurgery Stanford

belief of Committee representatives TRIDENT build provided providers to to of TTFields the therapy the We We increase to our confidence with moment these Steering MD newly of trial, specialty. our the including the engagements Clinic. and a exciting light engage concurred healthcare MPM of from LUNAR diagnosed MPM would TTFields at Institute radiation thorax from for Miami like leading represent launch Mayo of to recently continue the Anderson, each this focus institutions. and trial to and Cancer for In on to We opportunity an news believe sites KEYNOTE-BXX among business. the the our trial in GBM. further of discuss University The onboard with opportunity of awareness has take Pennsylvania, the evaluating cancer our I announced TTFields treatment

potential for has not one do prove will team expect opportunities and knowledge we seize indications. risen from our step their from valuable closer thanks NovoCure to to accomplish recent may team we to While news believe to entire to again I benefit to the contribute I to other aggressive trial moved TTFields. some in Time the most ahead look XXXX, and dedication the to materially available of over therapy launch our The we net gained With our for want extend LUNAR this cancer. revenues who call many the more to discuss thorax our forms quite challenges results quarter. our about MPM making to as to launches the to in of overcome patients continued reiterate to our my survival mission. time us turn that, mission financial in Ashley will

Ashley Cordova

Thank In revenues, XXXX, first you, Asaf. of year-over-year XX% generated our GBM $XXX business the representing a in net increase. million quarter

driven in growth steady growth active by patient. XXXX. the net Medicare from active revenues net successful Our was of normalized half first revenue resulting fee-for-service patient to per the durable the of a from denied net beneficiaries revenues reverted levels improvement and appeal previously Incremental

a and third adjust net fourth must and incremental revenues the in respectively. As quarter-over-quarter comparisons million $X XXXX for $XX revenue result, quarter the reported million

claims XXXX. We increase and continue claims, end quarter, the an of the predict. are these X% the appeal XXXX denied first XXXX, previously cadence first payments actively to and at we and on to impossible size quarter active the pursue increase versus of patients quarter a versus XX% the of had fourth of Medicare While

have past growth as improvements broadening delta reimbursement. a we revenues, we mix several the in of patients, benefit the period, prescriptions net seen of notable the rates Over active years between and reap patient received and favorable

ahead, expect to these difference rates growth favorable we in commercial the compress organization Looking matures. as our metrics among

profit Moving an gross was the XX% down in million the P&L, first gross $XXX with margin. quarter XXXX of

benefits increased of in our scale supply within see We continue the chain. efficiencies to

readiness of reflects approach increase to from anticipation our support the efforts a our Our disciplined potential commercial in were the an spending well as ongoing XX% in commitment businesses in established maintain of SG&A indications. new QX $XX to future expenses organizational to growth of approvals as quarter XXXX.This million,

activities to Tumor we an to research invest expansion pivotal to marketing We in remain our our trials, in support invested and medical priorities in of and increase trial personnel increased our maximize development $XX allocation versus increase activity. investments to pre-clinical affairs XXXX. increase and capital the XX% the expenses platform. million due quarter, continue of an an development and in QX potential Our the strategically personnel of growth Treating Fields research, in This for primarily expenses Phase programs, clinical product was the and and post X unchanged development

aggressive to we growth. forward, committed future remain Moving balancing investments profitability with in

$X Our advance The $X.X commercial quarter our the for making launches to loss trial prior committed and potential our of investments million, net loss infrastructure equating present indications. solid a late opportunity remain the was per regarding needed programs We development tumor to solidify recent the underscores our LUNAR to to only in future sizeable additional pipeline. stage announcement in our potential share.

on future before growth profitability. near remains investments in focus Our optimizing term

the adjusted quarter our an a $XXX with current about a metric, EBITDA on our provides same depreciation, Beyond hand. to investing of our million an performance interest, amortization operating balance per on share, non-GAAP in We share this XX% our period company. important specifically will With financial the of We generated from to million, confident compensation. is rate, and earnings I the best in financial strength future taxes, of adjusted call development continued was In the business. compensation, of our ended by provide continue capital and turn sheet tax remain in based backstop We and based to it increase of based detail that, EBITDA, it more attributable XXXX, as that measure quarter before Bill XXXX. we generation our earnings non-cash removes earnings of also impact to evaluate the share pipeline. believe material cash back structure, aggressively the first value items, and $XX reflects growth the

William Doyle

of the therapy we downstream more full Fields. many its and only We Through beginning Treating Treating Fields you, The Tumor Tumor potential learn ongoing effects to about the applications, and we preclinical believe efforts, explore Thank we to new Ashley. research platform. believe remain continue therapy, multiple we understand unlock levers to potential. clinical more combinations, the of our our full are

substantial new pipeline Our the market for expansion solid stage late years. existing programs few potential next over the create tumor indications into

cancers trials cell our there have Phase the little trial where In been lung by in cancer. earlier, ongoing we years brain recent addition very pancreatic ovarian deadliest for and one discussed progress metastases of has LUNAR cancer, in to non-small women, X cancer, caused

Tumor efficacy used opportunity with for INNOVATE-X these resistance chemotherapy the an of prognosis of exploration a Treating large currently standard Our combination Almost the unmet with for patients and Treating the with need ultimately Tumor our the patients follow-up. We third analysis in ovarian Fields poor. INNOVATE-X with trial of the all XX and in interim Fields INNOVATE-X together care. best represents tests address to continue cancer the quarter XXXX effective anticipate remains recurrent platinum taxane of paclitaxel. months develop

need. XX addresses significant Our remain poor in unmet a PANOVA-X and survival pancreatic trial in below also rates cancer pancreatic cancer cancer percent. prognosis X-year with

trial analysis X Tumor PANOVA-Xis represent Fields XXXX. in of weekly nab-paclitaxel to Treating exciting with of tests and Treating the in interim used next with our efforts to pilot gemcitabine. expand in abdomen. the our the year data data occur late two final Phase These of The trials promising PANOVA-X cancers steps to of Fields use Tumor expected Following effectiveness

it extension when opportunity cancer in our of late is late a of metastases METIS designed ability the kill lung to our months. has cancer. body research pipeline demonstrated lung expands trials cells. measure therapy six METIS cancer to intracranial brain in progression the non-small cell region the an trial Our to stage in already a of compared the dividing from where unique cell non-small METIS other our stage presents includes also scope to as

our final trial We in expect XXXX. data from METIS the

regions trials opportunity All of fold. by our offer that can will of These unique Treating different Fields. unique of They our of late twenty enhance cancer the and therapies, Tumor potential market attributes combination our optimal use distinct trials body, stage understanding indications. increase the address

We of patients. improve and through maintain our also programs product innovation to intended life quality in continue extend our believe, to can therapy of survival investments the we

increasing prioritize product usability delivered that Our focused dose Fields. product and patient innovations teams Tumor of Treating delivering remained on development the

are centric Tumor multiple design populations and generator, larger Fields We create optimize to across Treating electric to software patient support the opportunities evaluating arrays, our enabling field indications. generation team next

Tumor of cancer Washington clinical are exploring Center to University Treating action Fields in deaths. repair research innovative effective cell novel and pipeline, Center new Tumor Tumor the Investigators treatment Tumor melanoma may damage examples Dr. combinations, the and for Treating our at pathways. Beth of in of small for Fields in replication Beyond to Tumor concluded at use effect current Fields. exciting and Medical at have a brain St. Karanam the of identified Southwestern identify Through indications, of that a ongoing Deaconess the being Treating for Louis Tech Story have research identify immunotherapies in-vitro novel addition and Fields DNA carcinoma. stress to is optimal Treating treatment applications application, be Medical Fields conducted therapy. of These researchers renal Dallas of are Israel Treating Virginia sample

that As of knowledge to we have we beginning Treating greater the we potential many platform. just confidence the even true of Fields, understand applications continue to accumulate potential of evidence and are the Tumor more

to interest in the over had operator their I the Before on like for call thank for the phone NovoCure. to I questions, everyone would continued

the operator call team, Q&A. remain I'll We mission, potential back our of quarter maximize efforts With Treating Tumor long-term an over the and our team positioning and in turn in long-term of Our investing of strategy, commercial readiness for clinical growth advancement value. us initiatives another to development the our our to continue and confident now strong execution, shareholder delivered organizational the product that in Fields. sustain to

Operator

with Our Sandler. from Jason Instructions] is Bednar first Thank you. Piper question [Operator

please. question Your

Jason Bednar

and Bill, taking morning, not for wanted good have the start come questions here. with up to LUNAR, lot a probably Hey, of thanks I surprising questions. obviously

interpret the about how IDE, be the the the about discussed what approves LUNAR think sure timing Just and recommended enrollment be those FDA that I'm will I that of building data what's the let's enrollment I assuming release approval regarding this for are you hitting presentation, it a today, assume intern good. assume XXX long on that for but what's February, for original data to time think was way in line to shouldn't way the ask, you all right right later here target? the looks slated XXX then know, that year. out then to And the that, that submission on could play in

William Doyle

So, good and question you're again it's for morning, Jason. surprising. right, And thanks not your

to we stand meet will recommended target the into where today we more order to the basically be certainly actively get to the So, recruit XX in that patients those to with the our DMC, investigators of recruited. And need was organization recruitment trial. patients focus work it by approximately

Another the from DMC XX reduce previously, And another in from last from important of the we patient the patient done modular have the to component XX savings. clinical follow-up last we was important, the part. application months of that's being last part so, would with time and the of this in to submission the a is months, PMA recommendation the as expect

other already beginning are the work on of we So, modules to submission. the

over accelerate So, DMC, this by the our market in we to -- FDA recommendations we a general year. would the think of accepts if time the

Jason Bednar

on but And those later, to save that, you a commercial because helpful. that's do I question questions I'll want the business. a lot for I other know, have ask Okay, on of

whatever, business disruption here well. some probably to but the assume as your COVID impacts or U.S., feeling markets most to If prescribing quarter you answer Bill other So, in the it's about mean, seems in so, want then or safe can what with and you saw Ashley, April? the it, you affect to however, from the you're patterns during into the for talk international, U.S. I here

William Doyle

Sure.

color I'm for Pritesh, to the So to joined by the question. call and Shah, Chief your to Commercial our going just Pritesh give Q&A turn who the we're you will answer Officer,

Pritesh Shah

Great. the morning, you, good question. you and Thank for Bill Thank Jason.

initiate of we've backdrop make that to that our things sure left patients limited. key of to in the and bit the happening find our one immune on situations is all sure and not treatment way help that eligible sector, behind. a or on is are the immunocompromised in ability So be in treatment, These that of our we we're pandemic the back that are treatment many provide realize seek their the focused teams been patients or in may treatment and prepared We are to support. for the desire that, to oncology patient access end the make then no the things to their that particularly the a Those patients midst healthcare are sector.

So a bit but what's down. across if globe. on where the the we see more are will, markets then see that is shut we these pandemic access And better, within you open bit micro sometimes to little happen a may healthcare fluctuations, based happening may that the something

are And XXXX And and of this flexible in that that. almost impact the the on point saw our in to was XXXX, that. in saw. U.S. pressure was felt traffic because the look the front. early therapy Those primarily we on this if the the bit seeking that you'll greatest see that downstream year, we is quarter surgeries of So broad patient a below patients, of the really part active you a we results of

So a resection. getting of patients relying surgical we upon the bit are sort

of So patients patients looking aspects broad we they get disease an GBM we're on keep make sort on sure still where that top and seeing are treatment. but of the flexible, to we is not this that are because and important providers

Jason Bednar

much. very you Thank

Operator

question next comes from Our Kumar Evercore with ISI. Vijay

question, Your please?

Vijay Kumar

label Is that does the with what maybe Bill of at What for GBM X level, I FDA simplistic presuming these I and the given is expansion LUNAR to Congrats way just simplify, approval, Maybe like? as second company Xx the My thinking you a a maybe in what three the get chemo XX,XXX. Interim population? about this means pool a how could you understanding care XX,XXX guess, know this high patient TAM patient line that questions. start this And on as first is perhaps we line? standards the to to LUNAR. is update. received was have going I'll changing with fit this very and XX,XXX, of patients look

William Doyle

good area. excited are question, morning cell also say, recommendations expansion I start is we by set this of brain for off extremely with from new I'll to has non-small question. of So, lung to activities the specifically I'll again, just the of Vijay lung that the and In much your trial for the within broader before whole a cancer. thanks I business program it component the METIS DMC NovoCure. mentioned streams the cancer LUNAR really a of at treat answer metastases into of company prepare and script, kicked one the

you us, our that, the our have mentioned program, Treating modality focus Treating background, our pardon to in mentioned say, seeing program in to immunotherapies just added it's I the non-small a very our Tumor combination Tumor Tumor other line, radiation is to in very Fields just in Treating of it's does What ISP to standard of care we is with in Fields. work, in Fields. also can backbone we new a If We and the lung Treating said care provide we're adding lung standard clinical all in amount which Tumor expect whatever a to [ph] X to MSD cancer be that first on to preclinical And cell at new Also me, would KEYTRUDA. cancer. of what collaboration cell preclinical our across in development in to the if work, board the means chemotherapy; now Fields. That our added. as box would our expect with the exciting line, work based there's top tremendous added non-small mean? be a radiotherapy, be chemotherapy pharmacology of And for

cell cases is cancer So it's of diagnosed XXX,XXX that treatment this really U.S. four for the But non-small About U.S. XX,XXX about second of year. program. year. there patients lung new broad in those in based estimated each are a received each specifically, the stage about line

based that cancer that's commonly the non-small suggest cell narrow treated is within with Advanced just Xx we where is are. the therapies So in was to care with again, and that's arm metastatic, arms standard the of Platinum in confines, this number chemotherapy, immunotherapy that LUNAR as you with to changing or lung and designed, Xx we number first contemplate an in with line. see. And combination combination

Vijay Kumar

think just in layer standard first then care? line is designed I the I months and efficacy think six update. I to show back Lunar, chemo ovarian, I I three of of interim is one, signal guess, or that to Understood, ovarian don't the that an at weren't trials weren't But we interim. context expecting this. should in I we the how about mean, was, to us ago, had the these interim care readout what guess is if standard were, of to of go many if think messaging

William Doyle

data designed has those of indication. each respect committee. specifically of So, X Each Phase one each our again, with monitoring own stage, one its those trials, is to late of trials for trials that

we for trials and believe their to recommend, continue to continue recruit We conclusion. we allow will to the little very that those would their, So, interim alpha through spend analyses.

so, for in anyone ovarian to expectations again, that that for cancer we change specifically, With first the I wouldn't respect other trials. And suggest LUNAR, script the notwithstanding the the great their news mentioned And they first progress line into prognosis or and but line therapy move progress. poor. is for second once time, women then very platinum therapy, fail most ultimately again, their over will line, may

on cancer that Our is therapy. population focused that's INNOVATE in trial trial, first first X failed our Phase ovarian trial, line

Vijay Kumar

may. I last if one, then quick one Understood. And

based QX, that last zero Ashley, year, you the further things last element -- CMS being backlog contribution or catch-up perhaps, should CMS the with a back processing in some timing payments is I we that are from trends, recognized be of No payments. guess, on half year's less I versus just model, know, is guess.

Ashley Cordova

VJ. the forward as to everybody you thank we It's point important look to model. for realize Yes, an

for there Optune newly impossible and collections the receiving a potential GBM. claims there So But we and Medicare significant coverage to simply prior pursue would from these is And not looking again for continue but This to is to impossible the diagnosed in really backlog We size that our these and in terms predict to volume you aggressively, of right. forward aggressively model cadence size. control. in do of recommend of cadence that I out reason, pursue predict. that is attempt in and to your

Vijay Kumar

guys. Thanks

Operator

Difei next Mizuho. question is Our from Yang with

Daniel Clark

is morning. Dan Difei. on for Clark This Hi, good

share clinical does you and can the ongoing of trials this us, your from vary one Just frequency in by meetings DMC indication?

Ashley Cordova

you. lost we Dan,

Daniel Clark

Sorry. now? hear Can me you

William Doyle

Yes,

Ashley Cordova

Yes.

Daniel Clark

my apologies. Okay,

William Doyle

It's that meets trials, Yes. year. the once each simple these a answer fairly of for a DMC

Daniel Clark

it. Thank got you. Okay,

Operator

All right.

next comes Northland is your Jason line Jason, with from Northland Our question Capital Capital. Wittes from open.

William Doyle

Jason, if are you we hear don’t speaking. you

Operator

with mute check I Larry button. question. with go Fargo. Biegelsen your Please move ahead. the Wells next Please permission, can your to Sir,

Larry Biegelsen

taking Hey, good the Bill, you for question. morning, okay? Thanks guys. me can hear

William Doyle

morning. Good Larry. can I

Larry Biegelsen

to the we've the I some we Bill, sure. the talked communication just just release you when said came of results But highly on press two to to experts positive. unusual. wanted highly the came LUNAR, make when DMCs it out, is was thought

precedent? positive? there the are I first And up? question DMCs my guess you follow I Could is So that a positive? And is, confident have other scenarios recommendation there one are be not that is how

William Doyle

believe there We just as a DMC. interpret recommendation. do don't beyond the aware originally recruit, to not a is very were anticipated, had made. So very there's the, and fact there's are to And, and positive able were which, had beyond this communication that COVID, That we statistical highly events, more believe this a result extended positive for full are of another that confident the the the and it as were as analysis, the a and they that data, and that. make specifically simple because to We parts from this, of that. stems precedent to from they they time of time the two we the trial they way said, they was recommendations type event, that the to able very

Larry Biegelsen

unethical? stop just control not? how XX the What's the And the the patients and determining for didn't the trial it's why questions. do unethical then to patients arm? ethical or mean possibly to whether possibly if does rule And now, it final what Thanks they taking it's for you randomize randomize

William Doyle

seen Yes, haven't again, you know, we so data. the

likely to the Treating receive in The going the with all for speak just analysis. we of XX investigators very our alpha work again, trial the the arm Tumor cannot reason small of of control to think remaining the Fields. standard minus stop point allowed is are do spend the quickly care, because at again, And, words they, patients enroll themselves. this the the in I patients,

Larry Biegelsen

FDA does maybe change? lastly, there It what Thanks just the approve the not risk of Is if happens protocol that? any again. but

William Doyle

the with working FDA. are we Again,

recommendation, We're and the far, of have too We submitted outcomes IDE are the the [ph], so make so DMC to the we we we'll possible final with me, acronyms. everyone. with name when There FDA. of from good. the a that variety many have supplement determination pardon information PMA What's FDA, the will interacting available the

Larry Biegelsen

Thanks Bill. so much,

Operator

with Cory from Kasimov Morgan. next Our JP comes question

Cory Kasimov

you. for them of couple a I've Question,

but of in issue interim obviously on at check, investors treat speak, you totally you're hit And this expectations on which believe wanting skis, did Lua, super to tumors I complicated first the these their not GBM, Optune a out to point. interim get keeping understand indication very then difficult one there. over most analyses so is So for close clearly and the and this you of worst to out

more have shouldn't ovarian we and why for So interims? I pancreatic then have one followup. And expectations

William Doyle

to if of their extraordinary. lung a statement with was Yes, tell want very, all function you. investors The I use we GBM with cancer to I we'd that's situation that get as situation The was reiterate want skis, as think, Cory, trial were performance. first the to the ovarian well just don't I over we the duration INNOVATE-X, clearly, the recruiting, the non-small of mentioned recruiting very as If of cancer, cell did quickly.

we and just think alpha trials, such I'll we all don't that [ph] we so don't said again by phrase, skis have we small different. expect they're investors just get use other over these should complete the to in as recruitment interims And out your cent their QX a that

Cory Kasimov

trials. this just analysis but there think ongoing I as it was you on in I track to your this mean final of with mets. a METIS in this? to then, prior up follow brain efficacy for conducted for XXXX, and Okay you'd all for said this has interim trial been interim relates analysis the do

you can So anything there that? on comment is

William Doyle

trial so pipeline [ph] does is not the Yes, regarding so have adaption one this Cory, that stage is late METIS the analysis. of interim an

Cory Kasimov

Okay, DMC just doing that's is so the the it? safety annual check and

William Doyle

Correct.

Cory Kasimov

have reason one on in particular why any Okay, wouldn't that put you one?

William Doyle

design. and was very any METIS? you design the Uri call with the have do trial color of Let is much the me, Uri on involved he on

Uri Weinberg

everybody. morning good Yes,

considerations to study So in study, patients have their not the study, have an to the with reason and terms XXX the from this progression, intracranial include don't analysis, smaller there interim on of an on why and any statistical this want analysis no it for is did analysis we interim cell interim on of this one is not so we basically XXX the non-small METIS endpoint lung for patients, cause brain do metastasis and cancer and need was one. we primary deterioration

Cory Kasimov

thank you. helpful. It is Okay,

Operator

you. Thank

from is question next Northland. go with Jason Our Please ahead. Wittes

Jason Wittes

Thank me, hear you can you. apologies. Hope

William Doyle

we got you now. Yes

Ashley Cordova

Yes, we can.

Jason Wittes

[ph] Ruden threw and Apparently the by Scott finally go thank at my phone back got you. I'm unstuck Yes, and me. stuck, and stopped so mute

done from preclinical I the doubling is some first wouldn’t just as you you've seemed is that I with So that or LUNAR through be, of but effect Is new don’t an on to data animal guys read came in based know, direct down, the out? immunotherapies. fact more well off, data which there announcement that amplification say or there terms

William Doyle

engaged these plus reason with with say our And strength Yes, data. And been And specifically going really the enthusiasm I'll activities, I about we our tremendous over fully for benefits were the development that the to expand XX beginning we're the just start significantly comment the financial on increasing activities, this described, of research for comment Ashley research Uri we've fact that is that reap the and to years. just generating investments. development but support investigators, this, I'm now able external of now amounts let of ask to and to in combinations on would Uri with immunotherapies.

Uri Weinberg

Thank you, Bill.

is lead colon do that in in to specifically and hallmarks death cancer basically of and in of and to published demonstrate other death, and Fields this So Fields vitro were we models the is exposure agent that GBX able immunogenic know data, Tumor with and models. in release calreticulin vivo, multiple immunogenic cells cells that cell on already of of what the What specifically and we that we release cancers have ATP. express treated Treating of lung in demonstrated cancer, surface in are TT cell is

the When And And also was researchers saw also independently That with All site. of as of these fact cells of vector the the an Fields in of of them control what and better tumor. for abundance these cancer vivo presenting antigens the data accompanied sites, presenting the cytotoxic by Florida, decrease T-cells in that animals, cells, process tumor see cells, against who basically immune in explains system increase dendritic in of we data they response the we of demonstrated from such David Fields. present the used presented act they of at response Fields, TT with nicely outside antigen this with that of together T-cells, residing and cancer against response, are by research the this as to augmentation course, the running And now. of the order increase Dr. the we tumors, signals tumor comes all Tran meaning of therapy, phagocytic preclinical in under serve at TT sites to and to volume that of the right and was very that augment increased immune anti-PD-X do in clinic from an e-cells infiltration is TT the we in activation the results vitro comes other like would tumor another the of of activate cells to NovoCure, antigen an that that better translates other as cells at overall that shows combine response course University cancer. to cells of immune in tumor and to the them, will and patients.

of we addition think So more than the expanded call, integration the logical, when with ago. Fields several that, LUNAR on be that study seems example. we TT concomitant first the see enough pembrolizumab even lung with non-small immunotherapies great Fields later in study new going KEYNOTE-BXX to and and another the and example is of to we incorporate at a And towards makes the with MSD checkpoint more combination TT on. of now an in inhibitors and on cancer started believe more with that more therapy excellent Merck, is run these I it I LUNAR line years are will but But projects sense collaboration in the cell with KEYTRUDA the is clinic to,

Jason Wittes

that to Okay, how you could very have a that that's results? in LUNAR exciting, terms get the given timeline and helpful announcement, trial potentially KEYNOTE-BXX thank be long you, of general will related and do to actually very enroll take

Uri Weinberg

and in committee opinion phase that includes we for sites open the assembled the the patient are the or will from on the first a currently key Corey MD to we of for as anticipated of leading study announce leaders Anderson, we And UPenn timelines have order [indiscernible] that completion see study are study, Langer with such the in steering once in. so from this sure and working the we

Jason Wittes

And MTM this through small comments? MTM, the Okay, right thank that is for you, any year, very point. specifically at if helpful. read lastly, we for is assuming this contribution, you those sounds mentioned be shouldn't for then like relatively It much

William Doyle

through. the read exactly Yes, I that's think right

and very enthusiastic, payers, net revenue in We but active, continue centers expect engaged XXXX. material very don't we be to with contribution

Jason Wittes

great, thank jump the you. much. very Okay I'll back Thank you in queue.

Operator

questions am I in further the sir. not you. any showing Thank And queue,

William Doyle

great. Okay

in frankly their of in circumstances, work and to quite want want strategy. brilliant the reminding difficult for So interest I want by thank very to I NovoCure for everyone their NovoCure. end to everyone thank our team I

the around the We develop therapy and have provided first we can who growth. platform applicable GBM. develop and drive the are financial a can in is tumor world. The been go, that patients still new that broadly our has to benefit from great strategy of to so The strategy cancers. in specifically way make is serve platform solid financially business the all to to business has future has long modality that a investments the to That strength we tremendous but independent company

product to growth. think the build fact been I business, to described generate I’ve in we further last development what in benefit virtuous financial GBM to that strength, clinical cycle; invest invest R&D patient and able points the a long-term quarter have as really $XX million and drive

just is you. things tried some of in side at Thank our future of benefits a quarter We’ve to this highlight the the forward clinical and and beginning look virtuous time are the in reports at this but we cycle. tremendously the of call, to it seeing as the work. We that exciting NovoCure continue we

Operator

And today’s and you you this your participation Thank concludes may disconnect. for call. conference now

NovoCure Limited (NVCR) 29 Apr 212021 Q1 Earnings call transcript