NovoCure Limited (NASDAQ:NVCR) Q4 2022 Earnings Call Transcript

NovoCure Limited (NASDAQ:NVCR) Q4 2022 Earnings Call Transcript February 23, 2023

Ingrid Goldberg: Good morning, everyone, and thank you for joining us to review Novocure’s Fourth Quarter and Full Year 2022 Performance. I’m joined on the phone by our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; 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.Novocure.com, under Quarterly Reports on our Investor Relations page. Before we start, 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 do not intend to update publicly any forward-looking statements, except as required by law. Where appropriate, we refer to non-GAAP financial measures to evaluate 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 attributable to our capital structure, tax rate and material non-cash 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 in our Form 8-K filed with the SEC today. These materials can also be accessed from our Investor Relations page on 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.

William Doyle: Thank you, Ingrid. And good morning, everyone. Novocure 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’ve treated over 27,000 patients, built a 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 Optune 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, announcing the pivotal LUNAR study and non-small cell lung cancer met its primary overall survival endpoint; completing the pivotal INNOVATE-3 interim analysis with final INNOVATE-3 data anticipated later this year; and announcing positive data in our pilot gastric cancer study and in Dr. David Tran’s 2-THE-TOP pilot study, which explored treating GBM patients with TTFields plus temozolomide and the immune checkpoint inhibitor, pembrolizumab.

Last week, we announced completion of enrollment of our pivotal PANOVA-3 study in pancreatic cancer. And as of this morning, we are just two patients away from completing enrollment of our pivotable METIS 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. Finally, 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 essential knowledge, built critical infrastructure, and established the financial strength to support future launches in new indications. In 2022, we generated over $0.5 billion in net revenue and ended the year with 3,430 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 TTFields therapy. As such, we remain focused on engagement and education of health care 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 Optune among patients. Seven years since FDA approval in newly diagnosed GBM, some providers still see TTFields as a new and experimental therapy. We want to ensure patients are aware of the benefits of Optune and are fully equipped to advocate for TTFields 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 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 TTFields. These studies have included large populations, such as Dr. Cory Neff of Duke University’s review of central brain tumor registry and IQVIA treatment data from 2015 through 2021, spanning 19,000 patients in the US treated for GBM. Others have analyzed long periods at a single center, such as the study from nonhomologous Na Homolce Hospital in Prague, which tracked GBM patients treated with TTFields over 18 years. We have also seen multiple real world evidence studies from our key Asian markets. A recent review in Frontiers in Oncology, by Dr. Xue Du of North Sichuan Medical College, found that the average growth rate for publications related to TTFields was 29% and stated that studying the therapeutic potential of TTFields 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 EF-14 clinical study. The real world studies contribute to the opus of clinical evidence supporting the use of TTFields and will be crucial to our efforts to drive greater adoption. I would like to close today with a discussion of the positive top line results from our pivotal LUNAR study. As a reminder, LUNAR was designed to evaluate the use of TTFields together with either immune checkpoint inhibitors or docetaxel for the treatment of Stage 4 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, demonstrating a statistically significant and clinically meaningful extension in overall survival for patients treated with TTFields together with standard therapies.

Further, we saw a statistically significant and clinically meaningful extension in overall survival for patients treated with TTFields and immune checkpoint inhibitors versus immune checkpoint inhibitors alone and a positive trend in overall survival for patients treated with TTFields and docetaxel versus docetaxel alone. We believe these data represent a crucial finding for patients diagnosed with Stage 4 non-small cell lung cancer. In the US, 46,000 non-small cell lung cancer patients seek treatment in the second line each year, as do thousands more around the world. Since pembrolizumab was approved in this setting in 2016, there has been little progress in extending survival for these patients. We believe the LUNAR data has 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 it to Asaf to discuss other updates in our clinical and product development efforts.

Asaf Danziger: Thank you, Bill. I would like to echo Bill’s excitement about the positive topline readout of the LUNAR study. LUNAR is a key achievement for Novocure. Novocure is our first pivotal study completed with immunotherapies and our first pivotal study treating solid tumors outside of the brain. It is also the first of four pivotal studies, which we expect to read out in the coming two years, which, if successful, will transform our company. I began my career at Novocure in 2002, more than 21 years ago, and I can attest that I have never felt more engaged or excited. Our employees have worked so hard, and I’m so eager for what awaits us. At an upcoming medical congress, we will present the full Lunar dataset. In summer and fall, we expect to release the top line and full results of the INNOVATE-3 pivotal study in ovarian cancer.

Early next year, we anticipate top line data from the METIS study. Shortly thereafter, we expect to announce the PANOVA-3 top line readout. And at 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 new arrays are thinner, lighter and more flexible than previous versions. They can also optimize the intensity of TTFields delivered to the tumor without a material increase in heat delivered to the scalp. Preclinical research has shown that increased intensity delivered to a patient’s tumor bed can potentially increase the efficacy of TTFields therapy without an increase in systemic toxicity.

We are utilizing this limited release to study patient use patterns with the new arrays. The data gathered will inform future launch plans in additional markets. After the successful launch in Austria, we are 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 TTFields therapy. Before handing the call to Ashley, I would like to thank my colleagues at Novocure for a successful 2022. Through your hard work, we have positioned ourselves to take advantage of immense 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.

Ashley Cordova: Thank you, Asaf. Novocure finished the year in a strong financial position and primed for growth in the coming years. In 2022, our GBM business generated $538 million in net revenue and $31 million in net cash from operations. 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 in net revenue. We are pleased to report that, as expected, our EMEA revenues are starting to return to prior level as the average net revenue per active patient month in Germany begins to recover. As a reminder, we expect this to be a gradual process that plays out for multiple quarters to come.

Collection from aged claims were lower in the fourth quarter compared to prior periods. For the full year, we reported $32 million in revenue from the successful appeals of previously denied claims for Medicare fee for service beneficiaries billed prior to established coverage. We will continue to actively appeal and pursue previously denied claims for beneficiaries settled prior to established coverage, but the cadence and amount of these Medicare payments are impossible to predict. We believe collections from those claims which were most accessible were largely exhausted in 2022. And the remaining outstanding claims will take time to collect. To reiterate from last quarter, in 2023, we expect net revenues to closely reflect the core drivers of our GBM business, active patients on therapy times net revenue per active patient per month times 12 month.

Gross margin for the fourth quarter was 78%, in line with our margin from the same period last year. SG&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 in 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 slate of pivotal clinical studies near conclusion, we plan to continue investing to explore the use of TTFields in new indications, evaluate opportunities to expand labels in our approved indications, and to study potential additive effects with novel standards of care.

Additionally, we continue to invest aggressively in product development efforts designed to optimize our therapy and patient’s quality of life. Our net loss for the fourth quarter was $0.36 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 therapies. 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 Optune users. Since she was a child, Linda Long dreamed of being a Philadelphia firefighter.

She chased that dream and became the city’s first female battalion chief in 2017. Linda was diagnosed with GBM in March 2021. After undergoing debulking surgery at Penn Medicine, she began chemotherapy and radiation treatment. Two dozen of her fellow firefighters took turns driving her to and from treatment session and paying her home visits. Her neighbors grew accustomed to seeing firetrucks parked outside of her home. Linda also began using Optune. In the almost two years since her diagnosis, Linda’s disease has not progressed. While using TTFields, she goes on daily walks in city parks, and makes jewelry out of stones and other objects she finds and picks up along the way. Last year, she participated in the National Brain Tumor Society’s Race for Hope.

Linda and her fellow firefighters helped raise $15,000. People like Linda are a 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.

Q&A Session

Operator: . Our first question comes from the line of Na Sun with JPMChase.

Na Sun: I’m calling in for Jessica Fye. So, one of the questions we were thinking about €“ and congratulations on the LUNAR data €“ is that how do you think the KOLs 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 Optune in patients who progressed on platinum or expanded to patients who are also treated with checkpoint inhibitors in the first line? Second question, more in general, how do we think about the timing for ovarian top line and what the data set will mean for Novocure?

William Doyle: Maybe I’ll start with the first question and then I’ll turn the second question over to Pritesh Shah to talk about ovarian. But first of all, thank you very much for your congratulations for the LUNAR top line. As Asaf mentioned during the prepared remarks, we couldn’t be more excited and energized. And everyone in the company is sort of heads down, preparing whether they’re in the regulatory group or whether they’re in the commercial group for the release of the data, and then all 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. And we expect that to be the label. And I will say the first label.

But as you allude to, the data, as we said, are profound when TTFields are combined with checkpoint inhibitors. And we think that does point in the direction of future clinical research to really 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. So non-small cell lung cancer is not what we call a one trial and done indication. It’s a very large indication. And we would expect to continue to explore the combination of TTFields and immunotherapies in other lines and in other combinations, so that doctors can prescribe it to all patients. With that, Pritesh, maybe you can talk a little bit about ovarian.

Pritesh Shah: I’ll remind everybody about the INNOVATE-3 study, which is our ovarian cancer study. We were very excited to announce that last patient was enrolled in Q4 of 2021. Again, as a reminder, there’s an 18-month follow up that’s ongoing on the study. And we expect top line, as you heard in the prepared remarks, in the summer timeframe. So, we remain excited to get to the data. Once we have the data, we will work with the ovarian cancer community to learn from their perspective on clinical implications. So, more to come on this front. And we remain very enthusiastic about helping the ovarian cancer community.

Operator: Our next question comes from the line of Jason Wittes with Loop Capital.

Jason Wittes: Congratulations on the LUNAR top line data. First of, is there an ETA or an expectation of when we will see the full LUNAR data?

William Doyle: I know most of you are aware of this. When we or any other company conducts a major clinical trial with market moving implications, we announce the success or failure as quickly as we know in a press release, but we don’t publish the specific data because that risks the ability to present at a future medical conference and to publish in a top tier journal. So, that’s the reason for this gap. We are eager to get the data to all the constituencies. And so, we’re in the process 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 it later this year.

Jason Wittes: 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? I’d be curious to know what you’ve heard from the field on that?

William Doyle: It’s tremendously exciting. Again, there hasn’t been any progress in this particular group of non-small cell lung cancer patients since the original immune checkpoint inhibitor trials six years ago. So, notwithstanding everything that we all read about the progress being made in multiple fronts in 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.

Operator: Next question comes in a line of Lei Huang with Wells Fargo.

Lei Huang: It’s Lei dialing in for Larry Biegelsen. Just a couple on LUNAR, please. Can you talk about your confidence level that the active and control arms in the study were balanced in terms of patient characteristics and first line therapy?

William Doyle: To remind everyone, this was a randomized study. And we’ve said that the control groups behaved as expected and that the arms were well balanced in terms of numbers. 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 show balance. And as I said, I’ll just say it again, appropriate and expected results in the control arms.

Lei Huang: In today’s press release, you mentioned that LUNAR met a key secondary endpoint on overall survival. So, you confirmed that the study hit on IO arm. It missed on docetaxel, but that was a positive trend. So, does that mean that the third endpoint on overall survival in terms of TTFields plus docetaxel against IO alone, that endpoint was missed?

William Doyle: Again, I think there’s nothing new other than what was announced in the press release. And again, let me just say how excited we are about this. So we’re hitting the primary endpoint, which was all patients treated with Tumor Treating Fields plus standard therapy compared to all patients treated with either docetaxel or immune checkpoint inhibitors combined, and we had a statistically significant and clinically meaningful improvement in that total group. And then, as you stated, in the second line €“ secondary endpoints, we saw statistically significant and profound improvement in the patients treated with immune checkpoint inhibitors plus TTFields compared to immune checkpoint inhibitors alone and a positive trend, but not statistical significance, in the patients treated with Tumor Treating Fields plus docetaxel compared to docetaxel.

Lei Huang: Just to be clear, you’re not commenting specifically on the third and secondary endpoint having to do with overall survival. You’re not commenting on that, like whether that hit or not?

William Doyle: That will come later this year.

Lei Huang: If I can squeeze in one more for Ashley, please. So, your revenue was down slightly in 2022. And that included some of the backlog collection, directionally, can you just talk about if you expect revenue to grow in 2023? If you do that backlog collection €“ I understand that was a low hanging fruit last year, that may be tougher this year. But if we just exclude that $32 million from 2022, do you see your revenue growing in 2023?

Ashley Cordova: Thanks for the question and the opportunity to reiterate this message because it is extremely important for everybody to understand in your modeling. So you have the right numbers. We did confirm that we recorded $32 million in Medicare from aged claims. So these are claims that were billed for patients that started prior to established coverage in the US, as you noted. And again, I will just reiterate, we continue to actively appeal and pursue these claims. But the collections that are most accessible were largely exhausted and the remaining outstanding claims will take time to collect. So we would not recommend you consider contribution from aged claims in your forward-looking model to remove that $32 million when you look at the baseline for 2023 And then, as we look forward where net revenue should more closely reflect the core drivers of our GBM business, which are active patient growth times net revenue per active patient per month times months on therapy.

So active patient growth should drive revenue growth as we look forward.

Operator: Our next question comes from the line of Jason Bednar with Piper Sandler.

Jason Bednar: Great to see all the progress here in closing up the enrollment on your Phase 3 programs. a question yet on METIS. But, look, I know some of these are still in process and waiting on sufficient patient follow-up for a few of them. But maybe what’s the right way to think about backfilling this pipeline. In short order, we’ve gone from four Phase 3 studies enrolling to potentially none here in a matter of days, just from today. How are you thinking about formally adding to the later stage pipeline? And has the recent experience of Tumor Treating Fields plus chemo and a few recent studies, HEPANOVA, the gastric cancer trial, and then LUNAR here just recently. Has that at all changed how you’re planning to approach future trials with Tumor Treating Fields?

Asaf Danziger: Our original trials was €“ basically, we use TTFields in comparing to standard of care. And our future trial is to combine TTFields with some experimental drugs. So, this basically puts us in a totally different regulatory area, which was different than what we used to have. So I do want to mention that we are excited and planning to run additional Phase 3 trials and within all the indications that you just mentioned and more. And the regulatory challenges is higher, and the fact that we are combining two experimental therapies make it a little bit more challenging. But we are all in and looking forward for the next trial.

Jason Bednar: Maybe just a quick follow-up on that before I add my other question. Should we expect additional Phase 3s to start within this calendar year?

Asaf Danziger: Absolutely.

Jason Bednar: Maybe coming back to Ashley. Apologies in advance for a lengthy question, but I do want to follow-up on Lei’s question there just prior to this one on 2023 revenue. When I think back to last year, we had that active patient guidance. I don’t think we have that here for 2023. But that was very helpful in using to accurately forecast revenue. This year, predicting revenue is a little bit different. We had the situation in Germany that’s affected modeling around revenue per active patient. You’ve communicated the whole situation on past Medicare claims. But you also have Medicare revenue per patient that’s rising. I think 9% here to start 2023. You have France that should be kicking in here any day now. And then I think you also have some international expansion with recently opened offices in Canada and Spain.

So, I guess, with all of that in mind, just wondering if you could comment on whether you’re comfortable with the Street modeling year-over-year revenue growth for this year.

Ashley Cordova: Jason, again, appreciate the opportunity to just reiterate. I want to make sure that the top line message that everyone hears is that they do need to remove the impact of these aged claims, so that you’re 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 growth factors in 2023, you’re focusing on the right things. We have continued penetration in our active markets as we continue to believe there’s opportunity to access more patients in newly diagnosed GBM in large markets like the US, Germany and Japan. We have geographical expansion. In 2023, in terms of revenue, that will primarily be France because, if we looked at some of the other markets, we’re doing important building efforts there, but it will take time to drive material revenue.

So 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 the payer collection pattern. And then, Germany should recover. We’ve talked about this, that that was a short term pain in 2022 for long term gain. It will take through 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. So I think those are the puts and takes. And when we look at the core fundamental driver, it’s going to be meeting expectation about active patient growth and then expect net revenue to be stable without the impact of the aged claims for Medicare.

Jason Bednar: Can Germany grow this year, Ashley?

Ashley Cordova: Certainly. Yeah, both, I would say, on a base business activations, but also in a recovery price. Yes.

Operator: Our next question comes from the line Greg Fraser with Truist.

Greg Fraser: I was wondering if you could comment on how the flex array launch is going. I know it’s early into focus. But maybe you can comment on how that launch is going so far and how to think about the expansion to the rest of Europe. On France, investors think about the potential ramp there and appreciate the comments that you just made, Ashley. But would it be fair to look back at the experience in Germany as a precedent for what uptake could look like in France over time?

Asaf Danziger: This is a great question that I actually was €“ looking forward to this kind of question. The flex array and the new arrays is something that not happen every year in Novocure. It’s happened every decade or so. I think our new arrays is something that we’re very proud about it. And the launch in Austria, we’re treating few dozen of patients, and so far the results are great. We’re still waiting to see long term results. But so far, we are very, very pleased with the launch. And we are going to move to Sweden and other countries after that. So I will say that it’s according to our plans and we feel very comfortable.

Ashley Cordova: 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 active patient development itself. So you’ll start to see active patients come online. And then I would expect to see revenue recognized for those active patients to lag a couple of quarters as we look to the collection cycle with 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 model the revenue towards the back half of the year.

Operator: Our next question comes from the line of Vijay Kumar with Evercore ISI.

Vijay Kumar: On the LUNAR trial, Bill, I think you mentioned it’s randomized, it’s well balanced. Do we know the PD-1 status of the patients in the treatment and control arm, mutation profile? And was that known for all patients or only some percentage of patients enrolled in the trial?

William Doyle: Again, Vijay, the answers to the questions you just asked and the other questions being asked about the specifics of the cohorts will be answered later this year at the medical conference.

Vijay Kumar: Maybe one more on the statistical plan for the study. I think the original power of the study was 80% power. I guess with the sample size being €“ is this study now a power to detect the secondary endpoints and the overall survival end point? I’m curious what’s happened in the powering of the study?

William Doyle: So there was no change to the powering of the study. And so, the LUNAR study remains powered to detect overall survival in the primary and in the two powered secondaries.

Vijay Kumar: Ashley, one 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 in fiscal 2022?

Ashley Cordova: Again, as a reminder, we recorded $32 million in revenue from aged claims in 2022. So that relates to cash that we collected on Medicare patients that were billed prior to established coverage in 2019. So aged claims from prior to the establishment of this coverage. We continue to appeal and pursue those claims. And we’ll continue to recognize and take that cash onto the balance sheet as we collect it, 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 our revenue growth as we look forward 2023 and beyond, given the fact that the most accessible aged Medicare claims have been captured on the balance sheet,

Vijay Kumar: In that 32 million, Ashley, how did that flow through? What was the cadence? I think maybe half of that came into €“ what was that 3Q and 4Q?

Ashley Cordova: If you just look at the top line, Vijay, you can see how that cadence the year. When you look at active patient growth and you see net revenue growth on top of that acceleration, you can attribute that to the aged claim.

Operator: Our next question comes from the line of Emily Bodnar with H.C. Wainwright.

Emily Bodnar: I’m curious with the INNOVATE-3 study reading out soon, if that was positive, can you maybe discuss launch plans for having to launch a non-small cell lung cancer and ovarian cancer in a fairly close timeframe? Is some of that launch work like overlapping? Or how do those kind of differ from each other? Maybe any enrollment update from the KEYNOTE-B36 study and first line modeling and when we may see some data on that study?

William Doyle: 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. Pritesh is responsible for that second group of activities. So, Pritesh, maybe you can comment on the activities required to launch in multiple indications.

Pritesh Shah: First of all, we would welcome that opportunity because it would be very exciting for us to bring TTFields therapy to multiple patient populations that can benefit from our therapy. I would say because of 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 our therapy works separately. Given that, and the fact that it’ll 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 this really becomes a benefit for us as we transcend from primarily a 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 launch opportunity, which is, first and foremost, once the data set is available, we’ll look to understand 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 FDA approval, which would allow us to then promote and market our 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.

William Doyle: With respect to your question on KEYNOTE-B36, just to remind everybody that KEYNOTE-B36 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 in non-small cell lung cancer. Enrollment is ongoing. And as has been always the case, we don’t report ongoing enrollment numbers, but there’s really no news. It’s going as planned and we’ll report when we have less patient in.

Operator: Thank you. And I’m showing no further questions at this time. And I would like to hand the conference back over to William Doyle for any further remarks.

William Doyle: I’d just like to echo what Asaf said in the prepared remarks that this couldn’t be more exciting a time to be working at Novocure. We’re on the threshold of bringing our therapy from patients with GBM to many more patients with many other extremely difficult to treat solid tumors. 2022 was a year of consistent and really exceptional execution at Novocure. And it’s laying the strong foundation for this exciting period to come. With four pivotal trials set to read out in the next 24 months, We’re absolutely in this transformational period. And we look forward to updating you on our progress throughout the year. And I’ll end, also echoing Asaf, and just thanking everybody at Novocure for their hard work last year. And 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.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.