Novocure Limited (NVCR) Q4 2022 Earnings Call Transcript

Novocure Limited (NASDAQ:NVCR) Q4 2022 Results Earnings Conference Call February 23, 2023 8:00 AM ET

Company Participants

Ingrid Goldberg - Vice President of Investor Relations

William Doyle - Executive Chairman

Asaf Danziger - Chief Executive Officer

Ashley Cordova - Chief Financial Officer

Pritesh Shah - Chief Growth Officer

Conference Call Participants

Na Sun - JPMorgan Chase & Co.

Jason Wittes - Loop Capital

Lei Huang - Wells Fargo

Jason Bednar - Piper Sandler

Greg Fraser - Truist Securities

Vijay Kumar - Evercore ISI

Emily Bodnar - H.C. Wainwright

Ingrid Goldberg

Good morning, everyone, and convey you for joining america to reappraisal Novocure's Fourth Quarter and Full Year 2022 Performance. I'm joined connected nan telephone by our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; and our CFO, Ashley Cordova. Other members of our executive activity squad are besides connected nan telephone and disposable for Q&A.

For your reference, slides accompanying this net merchandise tin beryllium recovered connected our website, www.Novocure.com, nether Quarterly Reports connected our Investor Relations page.

Before we start, I would for illustration to punctual you that our discussions during this convention telephone will see forward-looking statements and existent results could disagree materially from those projected successful these statements. These statements impact a number of risks and uncertainties, immoderate of which are beyond our power and are described from clip to clip successful our SEC filings. We do not intend to update publically immoderate forward-looking statements, isolated from arsenic required by law.

Where appropriate, we mention to non-GAAP financial measures to measure our business, specifically adjusted EBITDA, a measurement of net earlier interest, taxes, depreciation, amortization and share-based compensation. We judge adjusted EBITDA is an important metric arsenic it removes nan effect of net attributable to our superior structure, taxation complaint and worldly non-cash items; and champion reflects nan financial worth generated by our business. Reconciliations of non-GAAP to GAAP financial measures are included successful our property release, net slides and successful our Form 8-K revenge pinch nan SEC today. These materials tin besides beryllium accessed from our Investor Relations page connected our website.

Following our prepared remarks today, we will unfastened nan statement for your questions.

I will now move nan telephone complete to our Executive Chairman, Bill Doyle.

William Doyle

Thank you, Ingrid. And bully morning, everyone. Novocure was founded successful 2000 to utilization nan caller uncovering that electrical fields tin beryllium harnessed to termination crab cells and widen crab diligent survival. Since 2000, we've treated complete 27,000 patients, built a resilient commercialized business and invested successful extended objective and merchandise improvement programs to heighten and grow nan unthinkable capabilities of Tumor Treating Fields therapy for nan curen of coagulated tumor cancers.

In 2022, Novocure achieved worldly milestones. In our commercialized business, we generated $538 cardinal successful nett revenue, received support for and launched Optune successful Canada, and finalized statement position to found nationalist reimbursement successful France, pending last publication; we successfully rolled retired our adjacent procreation arrays successful Austria, which are thinner, lighter, and whitethorn present much power to patients; and we made important advancement successful our objective programs, announcing nan pivotal LUNAR study and non-small compartment lung crab met its superior wide endurance endpoint; completing nan pivotal INNOVATE-3 interim study pinch last INNOVATE-3 information anticipated later this year; and announcing affirmative information successful our aviator gastric crab study and successful Dr. David Tran's 2-THE-TOP aviator study, which explored treating GBM patients pinch TTFields positive temozolomide and nan immune checkpoint inhibitor, pembrolizumab.

Last week, we announced completion of enrollment of our pivotal PANOVA-3 study successful pancreatic cancer. And arsenic of this morning, we are conscionable 2 patients distant from completing enrollment of our pivotable METIS study successful encephalon metastases from non-small compartment lung cancer.

2022 was a twelvemonth of coagulated execution that will style nan early of our company. And our teams are excited and motivated for each that awaits america successful 2023.

We will statesman today's telephone pinch a chat of our GBM business. We will past reappraisal our objective pipeline and adjacent word milestones. Finally, we will reappraisal our financial capacity successful nan 4th fourth of 2022 earlier opening nan statement for questions.

Our commercialized business, treating recently diagnosed GBM patients, provides a coagulated instauration for growth. We person gained basal knowledge, built captious infrastructure, and established nan financial spot to support early launches successful caller indications.

In 2022, we generated complete $0.5 cardinal successful nett gross and ended nan twelvemonth pinch 3,430 progressive patients connected therapy. The GBM business is beardown and sustainable, pinch penetration rates ranging from 30% to 40% successful our cardinal markets, but we cognize that location are galore much GBM patients that tin use from TTFields therapy. As such, we stay focused connected engagement and acquisition of wellness attraction providers, patients and caregivers.

Last year, we reorganized our GBM team, bringing sales, trading and aesculapian activity nether 1 umbrella pinch nan volition to streamline decision-making and amended coordination pinch nan extremity of renewing maturation successful our CNS business.

We are besides focused connected driving greater consciousness of Optune among patients. Seven years since FDA support successful recently diagnosed GBM, immoderate providers still spot TTFields arsenic a caller and experimental therapy. We want to guarantee patients are alert of nan benefits of Optune and are afloat equipped to advocator for TTFields curen successful due situations.

To this end, we person bolstered our patient-focused trading efforts and are pursuing greater consciousness crossed a assortment of accepted and caller media channels, including societal media. We judge our acquisition efforts pinch providers and patients, arsenic good arsenic our streamlined commercialized structure, will supply nan instauration to return to maturation successful nan coming years and supply a blueprint for commercialized launches successful different indications.

Published information and existent world grounds are paramount erstwhile moving to alteration nan modular of attraction and displacement expert practice. In 2022, we saw a bevy of existent world grounds publications supporting nan usage of TTFields. These studies person included ample populations, specified arsenic Dr. Cory Neff of Duke University's reappraisal of cardinal encephalon tumor registry and IQVIA curen information from 2015 done 2021, spanning 19,000 patients successful nan US treated for GBM.

Others person analyzed agelong periods astatine a azygous center, specified arsenic nan study from nonhomologous Na Homolce Hospital successful Prague, which tracked GBM patients treated pinch TTFields complete 18 years.

We person besides seen aggregate existent world grounds studies from our cardinal Asian markets. A caller reappraisal successful Frontiers successful Oncology, by Dr. Xue Du of North Sichuan Medical College, recovered that nan mean maturation complaint for publications related to TTFields was 29% and stated that studying nan therapeutic imaginable of TTFields has go a investigation hotspot.

The communal taxable of these publications has been nan validation and, successful galore cases, betterment complete nan results of our pivotal EF-14 objective study. The existent world studies lend to nan opus of objective grounds supporting nan usage of TTFields and will beryllium important to our efforts to thrust greater adoption.

I would for illustration to adjacent coming pinch a chat of nan affirmative apical statement results from our pivotal LUNAR study. As a reminder, LUNAR was designed to measure nan usage of TTFields together pinch either immune checkpoint inhibitors aliases docetaxel for nan curen of Stage 4 non-small compartment lung crab pursuing first statement progression pinch a regimen including platinum-based chemotherapy.

In January, we announced LUNAR met its superior endpoint, demonstrating a statistically important and clinically meaningful hold successful wide endurance for patients treated pinch TTFields together pinch modular therapies.

Further, we saw a statistically important and clinically meaningful hold successful wide endurance for patients treated pinch TTFields and immune checkpoint inhibitors versus immune checkpoint inhibitors unsocial and a affirmative inclination successful wide endurance for patients treated pinch TTFields and docetaxel versus docetaxel alone.

We judge these information correspond a important uncovering for patients diagnosed pinch Stage 4 non-small compartment lung cancer. In nan US, 46,000 non-small compartment lung crab patients activity curen successful nan 2nd statement each year, arsenic do thousands much astir nan world.

Since pembrolizumab was approved successful this mounting successful 2016, location has been small advancement successful extending endurance for these patients. We judge nan LUNAR information has nan imaginable to toggle shape nan curen paradigm for these patients, and much mostly constituent to nan early of coagulated tumor therapy.

Our squad continues to analyse nan information successful mentation for a afloat position and publication, and we look guardant to sharing nan information pinch physicians, patients and investors later this year.

With that, I will now move it to Asaf to talk different updates successful our objective and merchandise improvement efforts.

Asaf Danziger

Thank you, Bill. I would for illustration to echo Bill's excitement astir nan affirmative topline readout of nan LUNAR study. LUNAR is simply a cardinal accomplishment for Novocure. Novocure is our first pivotal study completed pinch immunotherapies and our first pivotal study treating coagulated tumors extracurricular of nan brain. It is besides nan first of 4 pivotal studies, which we expect to publication retired successful nan coming 2 years, which, if successful, will toggle shape our company.

I began my profession astatine Novocure successful 2002, much than 21 years ago, and I tin attest that I person ne'er felt much engaged aliases excited. Our labor person worked truthful hard, and I'm truthful eager for what awaits us.

At an upcoming aesculapian congress, we will coming nan afloat Lunar dataset. In summertime and fall, we expect to merchandise nan apical statement and afloat results of nan INNOVATE-3 pivotal study successful ovarian cancer. Early adjacent year, we expect apical statement information from nan METIS study. Shortly thereafter, we expect to denote nan PANOVA-3 apical statement readout. And astatine astir nan aforesaid time, we expect commercialized launches successful non-small compartment lung crab and ovarian cancer, pinch much to travel successful 2025 and beyond. This is an unthinkable clip to beryllium astatine Novocure.

I would beryllium remiss to not mention nan team's caller achievement, launching our adjacent procreation array successful prime European markets. Our caller arrays are thinner, lighter and much elastic than erstwhile versions. They tin besides optimize nan strength of TTFields delivered to nan tumor without a worldly summation successful power delivered to nan scalp. Preclinical investigation has shown that accrued strength delivered to a patient's tumor furniture tin perchance summation nan efficacy of TTFields therapy without an summation successful systemic toxicity.

We are utilizing this constricted merchandise to study diligent usage patterns pinch nan caller arrays. The information gathered will pass early motorboat plans successful further markets. After nan successful motorboat successful Austria, we are preparing to grow nan programme to Sweden. Our caller arrays are nan first of what we expect to beryllium a agelong statement of merchandise enhancements designed to optimize TTFields therapy.

Before handing nan telephone to Ashley, I would for illustration to convey my colleagues astatine Novocure for a successful 2022. Through your difficult work, we person positioned ourselves to return advantage of immense opportunity successful nan coming years. I cognize you will each emergence to nan juncture arsenic you person galore times successful nan past.

I will now move nan telephone complete to Ashley to reappraisal our 4th fourth financials.

Ashley Cordova

Thank you, Asaf. Novocure vanished nan twelvemonth successful a beardown financial position and primed for maturation successful nan coming years. In 2022, our GBM business generated $538 cardinal successful nett gross and $31 cardinal successful nett rate from operations. Our durable commercialized business is fueling investigation and improvement and enables america to put aggressively successful mentation for caller merchandise launches and caller marketplace entry.

In nan 4th fourth specifically, we generated $128 cardinal successful nett revenue. We are pleased to study that, arsenic expected, our EMEA revenues are starting to return to anterior level arsenic nan mean nett gross per progressive diligent period successful Germany originates to recover. As a reminder, we expect this to beryllium a gradual process that plays retired for aggregate quarters to come.

Collection from aged claims were little successful nan 4th fourth compared to anterior periods. For nan afloat year, we reported $32 cardinal successful gross from nan successful appeals of antecedently denied claims for Medicare interest for work beneficiaries billed anterior to established coverage. We will proceed to actively entreaty and prosecute antecedently denied claims for beneficiaries settled anterior to established coverage, but nan cadence and magnitude of these Medicare payments are intolerable to predict. We judge collections from those claims which were astir accessible were mostly exhausted successful 2022. And nan remaining outstanding claims will return clip to collect.

To reiterate from past quarter, successful 2023, we expect nett revenues to intimately bespeak nan halfway drivers of our GBM business, progressive patients connected therapy times nett gross per progressive diligent per period times 12 month.

Gross separator for nan 4th fourth was 78%, successful statement pinch our separator from nan aforesaid play past year.

SG&A expenses successful nan 4th were $88 million, an summation of 25% year-over-year. This summation reflects an finance successful pre-commercial activities intended to build a beardown instauration up of imaginable early indications. We are besides investing aggressively successful marketplace entree resources to place and participate caller markets successful nan coming years.

Research and improvement expenses successful nan 4th totaled $55 million, pinch $206 cardinal invested for nan afloat year. As nan existent slate of pivotal objective studies adjacent conclusion, we scheme to proceed investing to research nan usage of TTFields successful caller indications, measure opportunities to grow labels successful our approved indications, and to study imaginable additive effects pinch caller standards of care. Additionally, we proceed to put aggressively successful merchandise improvement efforts designed to optimize our therapy and patient's value of life.

Our nett nonaccomplishment for nan 4th fourth was $0.36 per stock aliases $37 cardinal and adjusted EBITDA was a antagonistic $10 million.

Cash and short-term investments totaled $969 cardinal arsenic of December 31, 2022. With a multitude of near-term catalysts and galore maturation opportunities connected nan horizon, we are focused connected investing to recognize nan afloat capacity and applicability of our therapies. We judge these investments will thrust semipermanent worth for Novocure and alteration america to dainty galore much patients successful nan future.

I'd for illustration to adjacent coming by highlighting 1 of our Optune users. Since she was a child, Linda Long dreamed of being a Philadelphia firefighter. She chased that dream and became nan city's first female battalion main successful 2017. Linda was diagnosed pinch GBM successful March 2021. After undergoing debulking room astatine Penn Medicine, she began chemotherapy and radiation treatment. Two twelve of her chap firefighters took turns driving her to and from curen convention and paying her location visits. Her neighbors grew accustomed to seeing firetrucks parked extracurricular of her home.

Linda besides began utilizing Optune. In nan almost 2 years since her diagnosis, Linda's illness has not progressed. While utilizing TTFields, she goes connected regular walks successful metropolis parks, and makes jewelry retired of stones and different objects she finds and picks up on nan way. Last year, she participated successful nan National Brain Tumor Society's Race for Hope. Linda and her chap firefighters helped raise $15,000.

People for illustration Linda are a regular reminder of why we are present and nan effect we tin make arsenic we strive to widen endurance successful immoderate of nan astir fierce forms of cancer.

With that, I will move it backmost to nan usability for questions.

Question-and-Answer Session

Operator

[Operator Instructions]. Our first mobility comes from nan statement of Na Sun pinch JPMChase.

Na Sun

I'm calling successful for Jessica Fye. So, 1 of nan questions we were reasoning astir – and congratulations connected nan LUNAR information – is that really do you deliberation nan KOLs erstwhile they really spot nan information position will really use nan information to their patients? Specifically, do you deliberation they will limit nan usage of Optune successful patients who progressed connected platinum aliases expanded to patients who are besides treated pinch checkpoint inhibitors successful nan first line?

Second question, much successful general, really do we deliberation astir nan timing for ovarian apical statement and what nan information group will mean for Novocure?

William Doyle

Maybe I'll commencement pinch nan first mobility and past I'll move nan 2nd mobility complete to Pritesh Shah to talk astir ovarian. But first of all, convey you very overmuch for your congratulations for nan LUNAR apical line. As Asaf mentioned during nan prepared remarks, we couldn't beryllium much excited and energized. And everyone successful nan institution is benignant of heads down, preparing whether they're successful nan regulatory group aliases whether they're successful nan commercialized group for nan merchandise of nan data, and past each nan steps that are required to bring that therapy to patients.

With respect to your circumstantial question, nan proceedings was designed to dainty patients aft platinum failure. And we expect that to beryllium nan label. And I will opportunity nan first label. But arsenic you allude to, nan data, arsenic we said, are profound erstwhile TTFields are mixed pinch checkpoint inhibitors. And we deliberation that does constituent successful nan guidance of early objective investigation to really bring that operation to patients successful a assortment of cancers successful a assortment of lines. And we're already readying nan adjacent objective tests successful non-small compartment lung cancer. So non-small compartment lung crab is not what we telephone a 1 proceedings and done indication. It's a very ample indication. And we would expect to proceed to research nan operation of TTFields and immunotherapies successful different lines and successful different combinations, truthful that doctors tin prescribe it to each patients.

With that, Pritesh, possibly you tin talk a small spot astir ovarian.

Pritesh Shah

I'll punctual everybody astir nan INNOVATE-3 study, which is our ovarian crab study. We were very excited to denote that past diligent was enrolled successful Q4 of 2021. Again, arsenic a reminder, there's an 18-month travel up that's ongoing connected nan study. And we expect apical line, arsenic you heard successful nan prepared remarks, successful nan summertime timeframe. So, we stay excited to get to nan data. Once we person nan data, we will activity pinch nan ovarian crab organization to study from their position connected objective implications. So, much to travel connected this front. And we stay very enthusiastic astir helping nan ovarian crab community.

Operator

Our adjacent mobility comes from nan statement of Jason Wittes pinch Loop Capital.

Jason Wittes

Congratulations connected nan LUNAR apical statement data. First of, is location an ETA aliases an anticipation of erstwhile we will spot nan afloat LUNAR data?

William Doyle

I cognize astir of you are alert of this. When we aliases immoderate different institution conducts a awesome objective proceedings pinch marketplace moving implications, we denote nan occurrence aliases nonaccomplishment arsenic quickly arsenic we cognize successful a property release, but we don't people nan circumstantial information because that risks nan expertise to coming astatine a early aesculapian convention and to people successful a apical tier journal. So, that's nan logic for this gap.

We are eager to get nan information to each nan constituencies. And so, we're successful nan process of some preparing nan publication and submitting nan absurd for position astatine an upcoming aesculapian conference. As soon arsenic that's accepted, we'll fto you cognize precisely erstwhile and where, but you tin expect it later this year.

Jason Wittes

Has location been immoderate guidance from nan section successful position of enrollment successful tests aliases moreover GBM users station LUNAR announcement successful position of conscionable wide reaction? I'd beryllium funny to cognize what you've heard from nan section connected that?

William Doyle

It's tremendously exciting. Again, location hasn't been immoderate advancement successful this peculiar group of non-small compartment lung crab patients since nan original immune checkpoint inhibitor tests six years ago. So, notwithstanding everything that we each publication astir nan advancement being made successful aggregate fronts successful cancer, this has been different stubborn, difficult to dainty cohort.

So I deliberation it's exciting. And I deliberation nan communities understand that this is nan aforesaid physics that we're applying to a different region of nan body. And so, it underlines nan expertise of Tumor Treating Fields to conflict difficult to dainty coagulated tumors and is benignant of mutually reinforcing of each of our efforts.

Operator

Next mobility comes successful a statement of Lei Huang pinch Wells Fargo.

Lei Huang

It's Lei dialing successful for Larry Biegelsen. Just a mates connected LUNAR, please. Can you talk astir your assurance level that nan progressive and power arms successful nan study were balanced successful position of diligent characteristics and first statement therapy?

William Doyle

To punctual everyone, this was a randomized study. And we've said that nan power groups behaved arsenic expected and that nan arms were good balanced successful position of numbers. And we look guardant to sharing each nan specifications pinch you, arsenic I said, later successful nan summer. But each nan indications arsenic we announced successful nan property merchandise show balance. And arsenic I said, I'll conscionable opportunity it again, due and expected results successful nan power arms.

Lei Huang

In today's property release, you mentioned that LUNAR met a cardinal secondary endpoint connected wide survival. So, you confirmed that nan study deed connected IO arm. It missed connected docetaxel, but that was a affirmative trend. So, does that mean that nan 3rd endpoint connected wide endurance successful position of TTFields positive docetaxel against IO alone, that endpoint was missed?

William Doyle

Again, I deliberation there's thing caller different than what was announced successful nan property release. And again, fto maine conscionable opportunity really excited we are astir this. So we're hitting nan superior endpoint, which was each patients treated pinch Tumor Treating Fields positive modular therapy compared to each patients treated pinch either docetaxel aliases immune checkpoint inhibitors combined, and we had a statistically important and clinically meaningful betterment successful that full group. And then, arsenic you stated, successful nan 2nd statement – secondary endpoints, we saw statistically important and profound betterment successful nan patients treated pinch immune checkpoint inhibitors positive TTFields compared to immune checkpoint inhibitors unsocial and a affirmative trend, but not statistical significance, successful nan patients treated pinch Tumor Treating Fields positive docetaxel compared to docetaxel.

Lei Huang

Just to beryllium clear, you're not commenting specifically connected nan 3rd and secondary endpoint having to do pinch wide survival. You're not commenting connected that, for illustration whether that deed aliases not?

William Doyle

That will travel later this year.

Lei Huang

If I tin compression successful 1 much for Ashley, please. So, your gross was down somewhat successful 2022. And that included immoderate of nan backlog collection, directionally, tin you conscionable talk astir if you expect gross to turn successful 2023? If you do that backlog postulation – I understand that was a debased hanging consequence past year, that whitethorn beryllium tougher this year. But if we conscionable exclude that $32 cardinal from 2022, do you spot your gross increasing successful 2023?

Ashley Cordova

Thanks for nan mobility and nan opportunity to reiterate this connection because it is highly important for everybody to understand successful your modeling. So you person nan correct numbers. We did corroborate that we recorded $32 cardinal successful Medicare from aged claims. So these are claims that were billed for patients that started anterior to established sum successful nan US, arsenic you noted. And again, I will conscionable reiterate, we proceed to actively entreaty and prosecute these claims. But nan collections that are astir accessible were mostly exhausted and nan remaining outstanding claims will return clip to collect. So we would not urge you see publication from aged claims successful your forward-looking exemplary to region that $32 cardinal erstwhile you look astatine nan baseline for 2023

And then, arsenic we look guardant wherever nett gross should much intimately bespeak nan halfway drivers of our GBM business, which are progressive diligent maturation times nett gross per progressive diligent per period times months connected therapy. So progressive diligent maturation should thrust gross maturation arsenic we look forward.

Operator

Our adjacent mobility comes from nan statement of Jason Bednar pinch Piper Sandler.

Jason Bednar

Great to spot each nan advancement present successful closing up nan enrollment connected your Phase 3 programs. [indiscernible] a mobility yet connected METIS. But, look, I cognize immoderate of these are still successful process and waiting connected capable diligent follow-up for a fewer of them. But possibly what's nan correct measurement to deliberation astir backfilling this pipeline. In short order, we've gone from 4 Phase 3 studies enrolling to perchance nary present successful a matter of days, conscionable from today. How are you reasoning astir formally adding to nan later shape pipeline? And has nan caller acquisition of Tumor Treating Fields positive chemo and a fewer caller studies, HEPANOVA, nan gastric crab trial, and past LUNAR present conscionable recently. Has that astatine each changed really you're readying to attack early tests pinch Tumor Treating Fields?

Asaf Danziger

Our original tests was – basically, we usage TTFields successful comparing to modular of care. And our early proceedings is to harvester TTFields pinch immoderate experimental drugs. So, this fundamentally puts america successful a wholly different regulatory area, which was different than what we utilized to have. So I do want to mention that we are excited and readying to tally further Phase 3 tests and wrong each nan indications that you conscionable mentioned and more. And nan regulatory challenges is higher, and nan truth that we are combining 2 experimental therapies make it a small spot much challenging. But we are each successful and looking guardant for nan adjacent trial.

Jason Bednar

Maybe conscionable a speedy follow-up connected that earlier I adhd my different question. Should we expect further Phase 3s to commencement wrong this almanac year?

Asaf Danziger

Absolutely.

Jason Bednar

Maybe coming backmost to Ashley. Apologies successful beforehand for a lengthy question, but I do want to follow-up connected Lei's mobility location conscionable anterior to this 1 connected 2023 revenue. When I deliberation backmost to past year, we had that progressive diligent guidance. I don't deliberation we person that present for 2023. But that was very adjuvant successful utilizing to accurately forecast revenue. This year, predicting gross is simply a small spot different. We had nan business successful Germany that's affected modeling astir gross per progressive patient. You've communicated nan full business connected past Medicare claims. But you besides person Medicare gross per diligent that's rising. I deliberation 9% present to commencement 2023. You person France that should beryllium kicking successful present immoderate time now. And past I deliberation you besides person immoderate world description pinch precocious opened offices successful Canada and Spain. So, I guess, pinch each of that successful mind, conscionable wondering if you could remark connected whether you're comfortable pinch nan Street modeling year-over-year gross maturation for this year.

Ashley Cordova

Jason, again, admit nan opportunity to conscionable reiterate. I want to make judge that nan apical statement connection that everyone hears is that they do request to region nan effect of these aged claims, truthful that you're starting disconnected pinch a cleanable base, right? That is very captious arsenic it is simply a cardinal contributor of nan number successful 2022.

But past erstwhile you constituent to nan maturation factors successful 2023, you're focusing connected nan correct things. We person continued penetration successful our progressive markets arsenic we proceed to judge there's opportunity to entree much patients successful recently diagnosed GBM successful ample markets for illustration nan US, Germany and Japan. We person geographical description .

In 2023, successful position of revenue, that will chiefly beryllium France because, if we looked astatine immoderate of nan different markets, we're doing important building efforts there, but it will return clip to thrust worldly revenue. So I would attraction connected France coming online successful nan opening of this twelvemonth and past spot it statesman to lend to gross towards nan backmost half of this twelvemonth arsenic we summation acquisition pinch nan payer postulation pattern.

And then, Germany should recover. We've talked astir this, that that was a short word symptom successful 2022 for agelong word gain. It will return done nan extremity of nan twelvemonth to recover, but you tin benignant of look astatine that arc complete nan people of 2022 and expect it to statesman to recover. So I deliberation those are nan puts and takes. And erstwhile we look astatine nan halfway basal driver, it's going to beryllium gathering [ph] anticipation astir progressive diligent maturation and past expect nett gross to beryllium unchangeable without nan effect of nan aged claims for Medicare.

Jason Bednar

Can Germany turn this year, Ashley?

Ashley Cordova

Certainly. Yeah, both, I would say, connected a guidelines business activations, but besides successful a betterment price. Yes.

Operator

Our adjacent mobility comes from nan statement Greg Fraser pinch Truist.

Greg Fraser

I was wondering if you could remark connected really nan flex array motorboat is going. I cognize it's early into focus. But possibly you tin remark connected really that motorboat is going truthful acold and really to deliberation astir nan description to nan remainder of Europe.

On France, investors deliberation astir nan imaginable ramp location and admit nan comments that you conscionable made, Ashley. But would it beryllium adjacent to look backmost astatine nan acquisition successful Germany arsenic a precedent for what uptake could look for illustration successful France complete time?

Asaf Danziger

This is simply a awesome mobility that I really was – looking guardant to this benignant of question. The flex array and nan caller arrays is thing that not hap each twelvemonth successful Novocure. It's happened each decade aliases so. I deliberation our caller arrays is thing that we're very proud astir it. And nan motorboat successful Austria, we're treating fewer twelve of patients, and truthful acold nan results are great. We're still waiting to spot agelong word results. But truthful far, we are very, very pleased pinch nan launch. And we are going to move to Sweden and different countries aft that. So I will opportunity that it's according to our plans and we consciousness very comfortable.

Ashley Cordova

Greg, I'll conscionable jump successful connected France. I deliberation you're not going to person to look astatine a proxy market. We tin look astatine nan existent progressive diligent improvement itself. So you'll commencement to spot progressive patients travel online. And past I would expect to spot gross recognized for those progressive patients to lag a mates of quarters arsenic we look to nan postulation rhythm pinch payers. So my proposal would beryllium to really look astatine nan acquisition and nan results of progressive diligent maturation successful nan beforehand half of nan year. And erstwhile you spot that trajectory, usage that exemplary nan gross towards nan backmost half of nan year.

Operator

Our adjacent mobility comes from nan statement of Vijay Kumar pinch Evercore ISI.

Vijay Kumar

On nan [indiscernible] LUNAR trial, Bill, I deliberation you mentioned it's randomized, it's good balanced. Do we cognize nan PD-1 position of nan patients successful nan curen and power arm, mutation profile? And was that known for each patients aliases only immoderate percent of patients enrolled successful nan trial?

William Doyle

Again, Vijay, nan answers to nan questions you conscionable asked and nan different questions being asked astir nan specifics of nan cohorts will beryllium answered later this twelvemonth astatine nan aesculapian conference.

Vijay Kumar

Maybe 1 much connected nan statistical scheme for nan study. I deliberation nan original powerfulness of nan study was 80% power. I conjecture pinch nan sample size being – is this study now a powerfulness to observe nan secondary endpoints and nan wide endurance extremity point? I'm funny what's happened successful nan powering of nan study?

William Doyle

So location was nary alteration to nan powering of nan study. And so, nan LUNAR study remains powered to observe wide endurance successful nan superior and successful nan 2 powered secondaries.

Vijay Kumar

Ashley, 1 for you here. Revenues, ex-CMS – if I understood, ex-CMS, are you a guiding to revenues being up year-on-year? And what is this CMS headwinds successful fiscal 2022?

Ashley Cordova

Again, arsenic a reminder, we recorded $32 cardinal successful gross from aged claims successful 2022. So that relates to rate that we collected connected Medicare patients that were billed anterior to established sum successful 2019. So aged claims from anterior to nan constitution of this coverage.

We proceed to entreaty and prosecute those claims. And we'll proceed to admit and return that rate onto nan equilibrium expanse arsenic we cod it, but it does not subordinate to nan halfway business of today. And so, our proposal arsenic you look guardant is to exemplary gross maturation successful statement pinch progressive diligent growth. Active diligent maturation will beryllium nan halfway driver of our gross maturation arsenic we look guardant 2023 and beyond, fixed nan truth that nan astir accessible aged Medicare claims person been captured connected nan equilibrium sheet,

Vijay Kumar

In that 32 million, Ashley, really did that travel through? What was nan cadence? I deliberation possibly half of that came into – what was that 3Q and 4Q?

Ashley Cordova

If you conscionable look astatine nan apical line, Vijay, you tin spot really that cadence [indiscernible] nan year. When you look astatine progressive diligent maturation and you spot nett gross maturation connected apical of that acceleration, you tin property that to nan aged claim.

Operator

Our adjacent mobility comes from nan statement of Emily Bodnar pinch H.C. Wainwright.

Emily Bodnar

I'm funny pinch nan INNOVATE-3 study reference retired soon, if that was positive, tin you possibly talk motorboat plans for having to motorboat a non-small compartment lung crab and ovarian crab successful a reasonably adjacent timeframe? Is immoderate of that motorboat activity for illustration overlapping? Or really do those benignant of disagree from each other? Maybe immoderate enrollment update from nan KEYNOTE-B36 study and first statement modeling and erstwhile we whitethorn spot immoderate information connected that study?

William Doyle

You whitethorn callback that, during nan year, we reorganized Novocure to really execute 2 things. First, to harvester and attraction each nan efforts connected our halfway GBM business, and past abstracted and harvester and attraction each nan efforts to motorboat nan caller indications. Pritesh is responsible for that 2nd group of activities. So, Pritesh, possibly you tin remark connected nan activities required to motorboat successful aggregate indications.

Pritesh Shah

First of all, we would invited that opportunity because it would beryllium very breathtaking for america to bring TTFields therapy to aggregate diligent populations that tin use from our therapy. I would opportunity because of nan level quality of our therapy, it allows america to make consciousness among nan aesculapian oncology community. So we're not having to amended connected system of action separately aliases nan measurement that our therapy useful separately. Given that, and nan truth that it'll beryllium chiefly nan aesculapian oncology community, nan activity that we're doing for LUNAR will parlay into nan activity that we will person to do for different indications. And this really becomes a use for america arsenic we transcend from chiefly a GBM business to a cookware tumor franchise. And arsenic you would expect, we're doing nan aforesaid level of mentation that you would do successful a motorboat opportunity, which is, first and foremost, erstwhile nan information group is available, we'll look to understand objective implications of nan data, we will look to spot really to position our therapy successful nan discourse of what's happening successful nan clinic, and past we will look guardant to nan commercialized planning, which would see build retired of our income organization, training, and yet getting to nan FDA approval, which would let america to past beforehand and marketplace our therapy.

So, tons of bully things happening connected this front. And we're already started connected this travel pinch LUNAR. And arsenic nan different indications travel into focus, we will proceed to double down connected those opportunities.

William Doyle

With respect to your mobility connected KEYNOTE-B36, conscionable to punctual everybody that KEYNOTE-B36 is simply a trial. It's a aviator proceedings that we're undertaking successful business pinch Merck, combining Tumor Treating Fields positive Keytruda successful nan first statement successful non-small compartment lung cancer. Enrollment is ongoing. And arsenic has been ever nan case, we don't study ongoing enrollment numbers, but there's really nary news. It's going arsenic planned and we'll study erstwhile we person little diligent in.

Operator

Thank you. And I'm showing nary further questions astatine this time. And I would for illustration to manus nan convention backmost complete to William Doyle for immoderate further remarks.

William Doyle

I'd conscionable for illustration to echo what Asaf said successful nan prepared remarks that this couldn't beryllium much breathtaking a clip to beryllium moving astatine Novocure. We're connected nan period of bringing our therapy from patients pinch GBM to galore much patients pinch galore different highly difficult to dainty coagulated tumors.

2022 was a twelvemonth of accordant and really exceptional execution astatine Novocure. And it's laying nan beardown instauration for this breathtaking play to come. With 4 pivotal tests group to publication retired successful nan adjacent 24 months, We're perfectly successful this transformational period. And we look guardant to updating you connected our advancement passim nan year.

And I'll end, besides echoing Asaf, and conscionable thanking everybody astatine Novocure for their difficult activity past year. And it seems almost unusual to beryllium talking astir 2022 astatine this constituent because we're truthful firmly into 2023, but besides convey you for each your efforts truthful acold and going forward.

Operator

This concludes today's convention call. Thank you for participating. You whitethorn now disconnect.