Q4 2022 Novocure Ltd Earnings Call
[music].
Okay.
Good morning, everyone.
Thank you for joining us to review <unk> fourth quarter and full year 2020 to your performance.
I'm joined on the phone by our executive Chairman Bill Doyle.
E L F <unk> and our CFO Ashley Cordova.
Other members of our executive leadership team are also on the call and available for Q&A.
For your reference slides accompanying this earnings release can be found on our website www dot dot com under quarterly reports on our Investor Relations page.
Before we begin I would like to remind you that our discussions during this conference call will include forward looking statements and actual results could differ materially from those projected in these statements.
These statements involve a number of risks and uncertainties some of which are beyond our control and are described from time to time in our SEC filings we.
We do not intend to update publicly any forward looking statement as required by law.
Where appropriate we will refer to non-GAAP financial measures to arrive at our business specifically adjusted EBITDA a measure of earnings before interest taxes, depreciation amortization and share based compensation.
We believe adjusted EBITDA is an important metric as it removes the impact of earnings tripled shale, our capital structure tax rate and material noncash items and best reflects the financial value generated by our business.
Reconciliations of non-GAAP to GAAP financial measures are included in our press release earnings slides and our form 8-K filed with the SEC today.
These materials can also be accessed from our Investor relations page of our website.
Following our prepared remarks today, we will open the line for your questions.
I will now turn the call over to our executive Chairman Bill Doyle.
Thank you Ingrid and good morning, everyone.
<unk> was founded in 2000 to exploit the novel finding that electric fields can be harnessed to kill cancer cells and extend cancer patient survival.
Since 2000, we have treated over 27000 patients filter resilient commercial business and invested in extensive clinical and product development programs to enhance and expand the incredible capabilities of tumor treating fields therapy for the treatment of solid tumor cancers.
In 2022, Novocure achieved material milestones.
In our commercial business, we generated 538 million in net revenue.
Received approval for and launched opportune in Canada.
And finalized contract terms to establish national reimbursement in France pending final publication.
We successfully rolled out our next generation arrays in Austria, which are thinner lighter and may deliver more energy to patients.
And we made significant progress in our clinical programs.
<unk> seen the pivotal lunar study in non small cell lung cancer met its primary overall survival endpoint.
Completing the pivotal innovate three interim analysis with.
With final innovate III data anticipated later this year.
And announcing positive data in our pilot gastric cancer study and then Dr. David trends to the top pilot study, which explore treating GBM patients with TT fields post <unk> and the immune checkpoint inhibitor timber Elisa map.
Last week, we announced completion of enrollment of our pivotal <unk> study in pancreatic cancer.
And as of this morning, we are just two patients away from completing enrollment of our pivotal <unk> study in brain metastases from non small cell lung cancer.
2022 was a year of solid execution that will shape the future of our company and our teams are excited and motivated for all that awaits us in 2023.
We will begin today's call with a discussion of our GBM business. We will then review our clinical pipeline and near term milestones.
We will review our financial performance in the fourth quarter of 2022 before opening the line for questions.
Our commercial business treating newly diagnosed GBM patients provides a solid foundation for growth.
We have gained the central knowledge built critical infrastructure and establish the financial strength to support future launches of new indications.
In 2022, we generated over $5 billion of net revenue and ended the year with 3430 active patients on therapy.
The GBM business is strong and sustainable with penetration rates ranging from 30% to 40% in our key markets.
But we know that there are many more GBM patients that can benefit from <unk> therapy.
As such we remain focused on engagement and education of healthcare providers patients and caregivers.
Last year, we reorganized our GBM team, bringing sales marketing and medical leadership under one umbrella with the intention to streamline decision, making and improve coordination with the goal of renewing growth in our CNS business.
We are also focused on driving greater awareness of <unk> among patients.
Seven years since FDA approval in newly diagnosed GBM some providers still see TT fields, as a new and experimental therapy.
We want to ensure patients are aware of the benefits of Optum and are fully equipped to advocate for <unk> treatment in appropriate situations.
To this end, we have bolstered our patient focused marketing efforts and are pursuing greater awareness across a variety of traditional and new media channel.
Channels, including social media.
We believe our educational efforts with providers and patients as well as our streamlined commercial structure will provide the foundation to return to growth in the coming years and provide a blueprint for commercial launches in other indications.
Published data and real World evidence are Paramount when working to change the standard of care and shift physician practice.
In 2022, we saw a bevy of real world evidence publications supporting the use of PT fields.
These studies have included large populations such as Dr. Cory Ness of Duke University's review of Central brain tumor registry and IQ via treatment data from 2015 through 2021 spanning 19000 patients in the U S treated for GBM.
Others have analyzed long periods at a single center such.
Such as the study from Dr. Mark as hospital in Prague, which tracked GBM patients treated with TT fields over 18 years.
We have also seen multiple real world evidence studies from our key Asian markets.
A recent review in frontier is in oncology by Dr. Xu due of North Sichuan Medical College found that the average growth rate for publications related to TT fields was 29% and stated that studying the therapeutic potential of TT fields has become a research hotspot.
The common theme of these publications has been the validation and in many cases improvement over the results of our pivotal <unk> clinical studies.
The real World studies contribute to the opus of clinical evidence supporting the use of PPE fields and will be crucial to our efforts to drive greater adoption.
I would now like to close today with a discussion of the positive topline results from our pivotal lunar study.
As a reminder, lunar was designed to evaluate the use of TT fields, together with either immune checkpoint inhibitors or docetaxel for the treatment of stage four non small cell lung cancer. Following first line progression with a regimen, including platinum based chemotherapy.
In January we announced lunar met its primary endpoint.
Emmons trading a statistically significant and clinically meaningful extension in overall survival for patients treated with TT fields together with standard therapies.
Further we saw a statistically significant and clinically meaningful extension in overall survival for patients treated with TT fields and immune checkpoint inhibitors versus immune checkpoint inhibitors alone.
And a positive trend in overall survival for patients treated with TT fields, and Docetaxel versus Docetaxel alone.
We believe these data represents a crucial finding for patients diagnosed with stage four non small cell lung cancer.
In the U S 46000, non small cell lung cancer patients seek treatment in the second line each year as do thousands more around the world.
Since <unk> was approved in this setting in 2016, there has been little progress in extending survival for these patients.
We believe the lunar data have the potential to transform the treatment paradigm for these patients and more generally point to the future of solid tumor therapy.
Our team continues to analyze the data in preparation for a full presentation and publication and we look forward to sharing the data with physicians patients and investors later this year.
With that I will now turn to SaaS to discuss other updates in our clinical and product development efforts.
Thank you Bill I would like to Echo <unk> excitement about the positive top line readout of the lunar study.
Lunar is our key achievements for Novocure.
Our first pivotal study completed with Immunotherapies and our first pivotal study treating solid tumors outside of the brain it.
It is also the first of four pivotal studies, which we expect to read out in the coming to us, which if successful will transform our company.
I began my career novel Q in 2000 to more than 21 years ago.
I can attest.
That's all I have never felt more engaged or excited.
Our employees have worked so hard and I am so eager for what awaits us.
It's an upcoming medical Congress, we will present, the full lunar dataset in.
In summer and fall, we expect to release the top line and full results of the innovate suite with the study in ovarian cancer.
Early next year, we anticipate top line data from the Manta study.
Shortly thereafter, we expect to announce the panel suite topline readout and it's about the same time, we anticipate commercial launches in non small cell lung cancer and ovarian cancer with more to come in 2025 and beyond.
This is an incredible time to be at Novocure.
I would be remiss to not mention the team's recent achievement launching our next generation array in select European markets, our newer rays of.
Lighter and more flexible than previous versions.
We can also optimize the intensity of TT fields delivered to the tumor without a material increase and he delivered to describe <unk>.
Preclinical research has shown that increased intensity delivered to a patients tumor bed can potentially increase the efficacy of TT fields therapy without an increase in systemic toxicity.
Utilizing this limited release to study patients use patterns within your race.
Did they together will inform future launch plans in additional markets.
After the successful launch in Australia, we have.
Preparing to expand the program to Sweden.
Our new arrays are the first of what we expect to be a long line of product enhancements designed to optimize TT fields therapy.
Before handing the call to Ashley I would like to thank my colleagues at normal Q4 successful 2020 to.
Through your hard work, we have positioned ourselves to take advantage of <unk> opportunity in the coming years.
I know you will all rise to the occasion as you have many times in the past.
I will now turn the call over to Ashley to review, our fourth quarter financials.
Thank you Asaf.
Now, let's finish the year in a strong financial position and primed for growth in the coming year.
In 2022, our GBM business generated $538 million, and net revenue and $31 million and net cash from operation.
Our durable commercial business is fueling research and development and enables us to invest aggressively in preparation for new product launches and new market entry.
In the fourth quarter, specifically, we generated $128 million of net revenue. We are pleased to report that as expected. Our EMEA revenues are starting to return to prior levels as the average net revenue per active patient in Germany begins to recover.
As a reminder, we expect this can be a gradual process that plays out for multiple quarters to come.
Collections from aged claims were lower in the fourth quarter compared to prior periods.
For the full year, we recorded $32 million in revenue from the successful appeal of previously denied claims for Medicare fee for service beneficiaries skilled prior to establish coverage.
We will continue to actively appeal and pursue previously denied claims for beneficiaries settled prior to establish coverage, but the cadence and amount of these Medicare payments are impossible to predict.
We believe collections for labor claims, which were most accessible where largely exhausted in 2022 and the remaining outstanding claims will take time to collect.
Reiterate from last quarter and 2023, we expect net revenue to closely reflects the core drivers of our GBM business expectations on therapy times net revenue per active patient per month times 12 months.
Gross margin for the fourth quarter was 78% in line with our margin from the same period last year.
G&A expenses in the quarter were $88 million.
An increase of 25% year over year. This increase reflects an investment in pre commercial activities intended to build a strong foundation ahead of potential future indications.
We are also investing aggressively and market access resources to identify and enter new markets in the coming years.
Research and development expenses in the quarter totaled $55 million.
With $206 million invested for the full year.
As the current fleet of pivotal clinical study.
We plan to continue investing to explore the use of TPS and new indication.
<unk> opportunities to expand tables in our approved indication and to study potential additive effects with novel standard of care.
Additionally, we continue to invest aggressively in product development efforts designed to optimize our therapy and patient quality of life.
Our net loss for the fourth quarter was 36 cents per share or $37 million and adjusted EBITDA was a negative $10 million.
Cash and short term investments totaled $969 million as of December 31, 2022.
With a multitude of near term catalysts and many growth opportunities on the horizon. We are focused on investing to realize the full capability and applicability of our therapy.
We believe these investments will drive long term value for Novocure and enable us to treat many more patients in the future.
I'd like to close today by highlighting one of our opportunities.
Thank you she was a child, Linda long dreamed of being a Philadelphia firefighter.
That dream and became the city's first female Italian G in 2017.
Linda was diagnosed with GBM in March 2021, after undergoing the bulking surgery at Penn Medicine, She began chemotherapy and radiation treatment.
<unk> 2000 of her fellow firefighters took turns driving her to and from treatment session.
Paying her home visits.
Our neighbors testing fire truck parts outside of our home.
Linda also began using <unk> in the almost two years since your diagnosis. When this disease has not progressed.
Do you think TT field. She goes on daily walks into city parks and makes jewelry out of stones and other objects <unk> five and takes up along the way.
Last year, she participated in the national brain tumor Society wafer hope Linda and her fellow firefighters helped raise $15000.
People like Linda Alright Daily reminder of why we are here and the impact we can make as we strive to extend survival in some of the most aggressive forms of cancer.
With that I will turn it back to the operator for questions.
Thank you.
As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby, while we compile our Q&A roster.
Our first question comes from the line of non Sun with J P. M. Chase. Your line is open. Please go ahead.
Hey, guys can you hear me.
And here you are good morning.
Good morning, Hi, I am calling in for Jessica Fye.
So one of the questions we were thinking about and congratulations on the new lunar data is that how do you think the kols when they think when they actually see the data presentation will actually apply the data to their patients specifically.
Do you think they will limit the use of opportune.
In patients who have progressed on platinum or expanded to patients who are also treated with checkpoint inhibitors in a first line.
And then second question Warren General.
Can we think about how do we think about the.
The timing for ovarian topline and what the data set will mean for novocure. Thank you.
Okay, So maybe I'll start with that.
The first question and then I'll turn the second question over to protest.
Two to talk about a variance.
But <unk>.
First of all thank you very much for your congratulations for the lunar topline.
<unk> mentioned during the prepared remarks.
We couldnt be more excited and energized.
And every one of the company is sort of heads down prepare.
Preparing whether they are in the regulatory group or whether they are in the commercial group.
For the.
For the release of the data and then all of the steps that are required to bring that therapy to patients with respect to your specific question. The trial was designed to treat patients after platinum failure.
We expect that to be the label.
We'll save the first label.
But as you alluded to.
Sure.
David as we said our profound when TT fields are combined with checkpoint inhibitors and.
And we think that does point in the direction of future clinical research too.
Really bring.
Bring that combination to patients in a variety of cancers in a variety of lines.
And we're already planning.
The next clinical trials in non small cell lung cancer non small cell lung cancer is not what we call. It one trial and done indication, it's a very large indication.
And we would.
Expect to continue to explore.
The combination of TT fields, and Immunotherapies and other lines and then other combinations so that doctors can prescribe it.
All patients with that protest, maybe you can talk a little bit about.
Ovarian.
Yes, Thank you bill.
To remind everybody about the innovate three study which is their ovarian cancer study. We were very excited to announce that last patient was enrolled in Q4 of 2021.
I learned from their perspective on clinical implications so more to come on this front.
We remain very enthusiastic about helping the ovarian cancer community.
Thank you.
We'll move on to our next question.
Our next question comes from the line of Jason Wittes with loop capital. Your line is open. Please go ahead.
Hi, Thanks for taking the questions and congratulations on the lunar topline data.
First off in terms of is there any expectation of when we will see the full lunar data.
Yes, again just for everyone's.
I know most of you are aware of this.
When we or any other company can.
<unk>.
<unk> clinical trial with with market moving implications.
We announced the success or failure as quickly as we know in the press release, but.
But we don't publish the specific data because that.
Risks.
<unk> ability to present at a future Medical Conference Center published in a top tier journal. So so that's the reason for this gap.
We are eager to get the data to all of the constituencies and so we're in the process of of both preparing the publication and.
Submitting the abstract for presentation at an upcoming medical conference.
As soon as that's accepted we'll let you know exactly when and where.
But you can expect that.
Later this year.
Okay. No. Thank you for that and has there been any reaction from the field in terms of enrollment in trials or even GBM users.
Post lunar announcement in terms of.
Just general reaction would be curious to know what you heard from the field on that yes.
Yes. So this is its tremendously exciting.
Again, there hasn't been any progress.
In this particular group of non small cell lung cancer patients since the original.
Immuno checkpoint inhibitor trials six years ago, so notwithstanding everything that we all read about the progress being made in multiple fronts and cancer. This has been another stubborn difficult to treat cohort.
So I think it's exciting and I think the communities understand that this is the same physics that we're applying to a different region of the body.
And so it underlines.
The ability of tumor treating fields to fight difficult to treat solid tumors and is sort of mutually reinforcing of all of our efforts.
Okay, great I'll jump back in queue. Thank you very much.
Thank you and one moment for our next question.
And our next question comes from the line of Lee Hung with Wells Fargo. Your line is open. Please go ahead.
Hi can you hear me.
Ken Good morning.
Hey, good morning, Thanks for taking my question.
<unk> dialing in for Mary Jane just.
Just a couple on lunar.
Please.
Can you talk about your confidence level that.
Active and control arms in the study.
We're balanced in terms of patient characteristics and first line therapy.
Sure.
To remind everyone. This is a randomized study.
And we've said that.
Control groups.
<unk> as expected.
The the arms were well balanced in terms of numbers and.
And we look forward to sharing all the details with you.
As I said later in the summer, but all the indications as we announced in the press release.
Sure well show show balance and as I said I'll just say it again.
Appropriate and expected.
Results in the controllers.
Got it Okay and then in todays press release, you mentioned that lunar met a key secondary endpoint on overall survival. So you can confirm that the study hit in.
In the IRR.
And Nathan Docetaxel, but that was a positive trend so does that mean the bird.
And point on overall survival in terms of <unk>, plus Docetaxel again I'll allow.
That endpoint with mist.
Again, I think there is nothing new.
Yes.
Other than what was announced in the.
The press release.
Docetaxel compared to Docetaxel.
Okay, So you're not you're just.
<unk> clearly not chronic and specifically on the third second and secondary endpoint, having to do with <unk> overall survival, you're not coming to me on that whether that handle that will come later this year.
If I can if I can squeeze in one more for Ashley. Please so your revenue with with with down slightly in 2022 and that included some of the backlog collection. He directionally can you just talk about if you expect revenue to grow in 23, if you exclude that backlog collection I understand.
You know that was a low hanging fruit last year that may be tougher this year, but let me just exclude that 32 million from 2022, you see your revenue growing and twenty-three. Thank you.
Yeah, well I think for the question and the opportunity to reiterate this message because it is extremely important for everybody to understand and your modeling. So you have the right numbers. We did confirm that we recorded $32 million and Medicare from aged claim. So these are claims that were billed for patients that started prior.
Two established coverage Mus as you noted and again I will just reiterate we continue to actively an appeal and pursue these claims but the collections that are most successful were largely exhausted and the remaining outstanding claims will take time to collect so we would not recommend you consider <unk>.
Contribution from age claims and therefore looking models to remove that 32 million. When you look at the baseline for 2023, and then as we look for word net revenue should more closely reflects the core driver is a R. G b a business, which are activation growth.
Time's net revenue proactive patient per month times, a month on therapy. So active patient grow should drive revenue growth has we look for it.
Thank you and one moment for our next question.
Our next question comes from the line adjacent vendor with.
Piper Sandler your line is open. Please go ahead.
<unk>, thanks for taking the questions.
Great to see all the progress here in close enough enrollment on your page three programs.
<unk> got a question for you then.
But we'll get.
No, they're they're still someone's your stolen process and where to put your patient followed for a few of them, but maybe what's the right way to think about <unk> pipeline.
In short order withdrawn from for Phase three studies enrolling too.
Essentially none your in a matter of days.
From today, how are you thinking about formally adding to the later stage pipeline and has the recent experience of tumor treaty fields plus chemo in a few few recent studies you don't have to know about the the gastric cancer trial and the lunar here. Just recently is that it all changed how you're planning to approach future trials.
<unk> fields.
So thank you very much for this question we are you know.
A regional tries was basically we use <unk>.
The field.
In comparing to standard of care in our future trial is to.
Combined filled with with some experimental drugs. So this is basically put us in totally different regulatory.
Area, which will which was.
Different than what we used to have so I do want to mention that we are excited and planning to.
To run additional face reach five and and all the indications that you just mentioned and more and the regulatory challenges.
The higher and the fact that we are combining two experimental therapies.
<unk> make it a little bit more challenging but.
We are all.
<unk> and looking forward for the next while.
Alright, maybe just a quick quick follow up on that before at my other other question is should we expect additional phase threes to to start within this calendar year.
Absolutely.
Okay.
And then maybe come back to to actually.
And apologize and get through a lengthy question, but I want I want to do a follow up on the latest question they're just.
Prior to this one.
2023 revenue.
When I think back to last year, we had that active patient guidance I don't think we have that here for 23, but that was very helpful and using to accurately forecast revenue. This year, you know predicting revenue go a little bit different you know we'd be had to the situation in Germany, that's affected modeling around revenue per activation you've communicate.
The the whole situation on passed Medicare claims, but you also have Medicare revenue per patient that's rising I think 9% here to start 2023, you a france that you'll be kicking in here any day now and then I think you all sorts of international expansion with you recently opened offices in Canada, and Spain. So I guess with with all that mine just wondering if you could call.
Comment on whether you're comfortable with the street you're modeling your over your revenue growth for this year.
Yeah, Jason again, I appreciate the opportunity to just reiterate I I wanted to make sure that the top line message that everyone. Here here is is that they do need to remove the impact of these H claims adventure starting off with a clean base right that is very critical as it is a key contributor of the number in 2022, but then when you point to the <unk>.
Growth factors in 2023, you're focusing on the right things. We have continued penetration interactive markets. As we continue to believe there is the opportunity to to access more patient to newly diagnosed GB N N large market fight the west, Germany, and Japan, we have geographical expansion in 2023.
In terms of revenue that will primarily be France, because as we looked at some of the other markets were doing important building efforts there, but it will take time to drive material revenue. So I would I would focus on France coming online in the beginning of this year and then see it begin to contribute to revenue towards the back half of this year as we gain experience with those hair collection.
Patterns, and then Germany should we cover we've talked about this at that with a short term pain in 2022 for long term gain it will take for the end of the year to recover but you can kind of look at that arc over the course of 2022 and expect it to begin to recover it. So I think those are the puts into.
<unk> and when we when we look at the core fundamental driver, it's going to be make an expectation about acting patient growth and then expect expect net revenue to be stable.
Without the impact of the age claims for Medicare.
Okay can Germany grow this you're actually.
Certainly yeah, both I would say on a base business occupations, but also in our recovery price yes.
Okay. Thank you.
Thank you and one moment for our next question. Our next question comes from the line of furniture with.
True as to your line is open. Please go ahead.
<unk>, thanks for taking the questions.
If you could comment on how the <unk> I know, it's early and focus but maybe you can comment on how how 'bout launches going so far and how to think about the expansion to the rest of Europe , and they're not France investors thinking about the potential ramp there and appreciate the comments that you just made actually but would it be fair to look back at the experienced in Germany.
As a precedent for what uptake could look like and say it's over time. Thanks, so much.
So thank you. This is a great question that I actually I.
I was looking for.
To this kind of question the flex array in the newer rays is something that no.
Not happen you know every year Novocure, it's up in every decade, or so I think I'll and you're right. It's something that we're very proud about it in the launch an in Austria, which wisdom.
Yeah.
2000 of patients and so far the results are great, we still waiting to see long term results, but the sofa.
Very very pleased with the launch and we're going to move to Sweden and other countries after that so.
I would say that it's according to our plans and we feel very comfortable.
And Greg I'll, just jump in on France, I think.
You're not going to have to look at a proxy market. We can look at the actual act of patient development itself. So you'll start to see active patients come online and then I would expect to see revenue recognized for those occupations to lag.
Couple of quarters, as we look to that the collection cycle of payers. So my recommendation would be to actually look at the experience and the results of active patient growth in the front half of the year and once you see that trajectory use that to model the revenue towards the back half a year.
Thank you and our next question comes from the line Vijay Kumar with Evercore.
Sorry. Your line is open. Please go ahead.
Hey, guys. Thanks for taking my question.
On the set lunar trial.
But I think you mentioned, it's randomized swelled balance.
Do we know the P D one status of the.
The patients in the treatment and control arm mutation profile.
And was it known for all patients are only some percentage of patients enrolled in the trial.
So again V J.
The answers to the questions you just asked and and the other questions being asked about the specifics of the.
The cohorts will be answered later this year.
The medical conference.
<unk> and then maybe one more on the <unk> plan for this study.
I think the original power of the study with security 80% powered.
I guess with the sample size being studied now.
A power to detect a secondary endpoints and the overall.
<unk> I'm I'm curious.
What's happening in the power probably about the study.
So there was no change to the powering of the study.
So.
Lunar study remains powered.
To detect overall survival in the primary.
And in the two powered secondaries.
Understood now maybe ask you want one for your revenues X.
<unk> if I understood <unk> are you a guiding to revenues.
Up your year and what what is this CMS headwind and physical 22.
Yeah. So again as a reminder will be recorded $32 million in revenue from aged claims in 2022, so that relates to cash that we collected on Medicare patients that were built prior to establish coverage in 2019, so aged claims from prior to the establishment at this coverage and we continue.
To appeal and pursue those claims and we will continue to recognize and take that cash on the balance sheet as we collected but it does not relate to the core business of today and so our recommendation as you look forward is to model revenue growth in line with active patient growth active patient growth will be the core driver of revenue growth as we look.
Four 2023 and beyond given given the fact that the most accessible age Medicare claims have have been captured on the balance sheet.
And that $32 million actually how did that flow through what's with the kittens.
I think maybe half of that came into <unk>.
Yeah, I mean, if you just look at the top line.
B J you can see how that turns out for the year. When you look at act of patient growth and easy net revenue growth on top of that acceleration you can attribute that to the H place.
Alright, thanks, guys.
Thank you and one moment for our next question.
And our next question comes from the line Emily Emily Blender with HD Wainwright. Your line is open. Please go ahead.
Hi, Thanks for taking my question I'm curious what the innovate three study reading out soon if that was positive.
<unk> launch plans for having to launch a non small cell lung cancer and ovarian cancer.
Fairly close timeframe.
Launch work like overlapping or how how did those kind of differ from each other and then maybe in the end.
<unk> update from the keynote B 36 study in first Lauren long and when we may see some data on that study.
Yeah. So.
You may recall that during the year.
We reorganized novocure to really accomplish two things first to.
Combine and focus all the efforts on our core GBM business, and then separate and combine and focus all the efforts.
To launch the new indications protection is responsible.
For that second group of activity. So tesh, maybe you can comment on the activities required to launch in multiple indications.
Yes, Sir Thank you Bill and thank you for the question Emily So first of all we are we would welcome that opportunity because it's would be very exciting for us to bring details therapy to multiple patient populations that can benefit from our therapy I would say because of the the platform nature of our therapy. It allows us to.
Generate awareness among the medical oncology community. So we're not having to educate on mechanism of action separately or the way that her therapy work separately.
Given that and the fact that it will be primarily the medical oncology community. The work that we're doing for lunar will parlay into the work that we will have to do for other indications.
And is this really becomes a benefit for us as we transcend from a primarily GBM business to a pan tumor franchise and as you would expect we're doing the same level of preparation that you would do in a in a launch opportunity, which is first and foremost once the data that is available will look to under.
And clinical implications of the data, we will look to see how to position our therapy in the context of what's happening in the clinic and then we will look forward to the commercial planning, which would include build out of our sales organization training and finally getting to the F. D. A approval, which would allow us to bend promote and market.
Therapy, so lots of good things happening on this front and we're already started on this journey with lunar.
And as the other indications come into focus we will continue to double down on those opportunities.
And with respect to your question on keynote B 36, just to remind everybody that keynote b 36 is a trial. It's a pilot trial that we're undertaking in partnership with Merck combining tumor treating fields plus keytruda in the first line.
And non small cell lung cancer.
Enrollment is ongoing and as has been always the case, we don't report Ah ongoing enrollment numbers, but there's there's really no news, it's going as planned and will report when we have less patient.
Okay.
Thank you and I'm showing no further questions at this time and I would like to have a conference back over to volume Doyle for any further remarks.
So I would just like to echo with a soft said in the prepared remarks that.
This couldn't be more exciting time to be working at an over church.
We're on the threshold of bringing our therapy from patients with with GBM two patients to many more patients with with many other extremely difficult to treat solid tumors.
2022 was a year of consistent and really exceptional execution no richer.
And is laying the strong foundation for this exciting period to come.
With four pivotal trials set to read out in the next 24 months.
Absolutely in this transformational period, and we look forward to updating you on our progress throughout the year and all and also echoing a soft and just thanking everybody has an overture for their hard work last year.
And it.
It seems almost strange to be talking about 2022 at this point because we're so firmly into 2023, but also thank you for all your efforts, so far and going forward.
This concludes today's conference call. Thank you for participating you may now disconnect.
The conference will begin shortly to raise and lower your hand during Q&A you can dial 911.
[music].