NovoCure Limited (NVCR) Q2 2024 Earnings Report, Transcript and Summary

Good day and thank you for standing by. Welcome to the NovoCure Q2 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Ingrid Goldberg. Please go ahead.

Good morning, and thank you for joining us to review NovoCure's second quarter 2024 performance. I am joined this morning by our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; and our CFO, Ashley Cordova. Other members of our executive leadership team will be available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.NovoCure.com and on our Investor Relations page under Quarterly Reports. 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 statement, except as required by law. Where appropriate, we will 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 thus 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 the 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. Our mission at NovoCure is to extend survival in some of the most aggressive forms of cancer. Through the development and commercialization of our innovative therapy tumor-treating fields, we have built a strong foundation treating glioblastoma, and with an anticipated approval to treat second line non-small cell lung cancer, we are on the threshold of helping many more patients in need. As we approach this year's milestone, the urgency of our mission is even greater for the entire NovoCure team. Entering 2024, we identified three key objectives which would best position us for success this year and beyond. One, to grow our commercial business in glioblastoma. Two, to launch TTFields therapy in non-small cell lung cancer. And three, to deliver on the promise of our clinical and product development pipelines. These objectives are ingrained in our business units and have been rallying points for our global teams. I am pleased to share that we are making significant progress on all three, and with the focus and dedication of the entire NovoCure team, we believe we can deliver on all three in 2024. This morning, we will review our progress on each objective, review our financial performance, and then open the line for questions. We ended the second quarter with 3,963 active patients on therapy, our highest number of active patients since commencing commercial operations. Our French GBM launch, now in its fifth quarter, continues to be a tailwind. France serves as a blueprint for a successful launch, employing our new synchronized commercial structure, a blueprint we will leverage in future expansion across the big five EU markets. Real world evidence of the benefits of TTFields therapy is a key resource for engaging with prescribers. In June at ASCO, Dr. Oliver Bähr of the General Hospital Aschaffenburg-Alzenau, presented top line data from the TIGER trial. TIGER examined TTFields therapy in the routine clinical care of newly diagnosed GBM patients in Germany. TIGER is the largest prospective non-interventional TTFields trial completed to date. Dr. Bahr reported a median overall survival of 19.6 months and median progression-free survival of 10.2 months, corroborating the leading survival outcomes observed in our Phase 3 EF-14 trial. Last month, in the Journal of Neuro-Oncology, Dr. Mrugala of the Mayo Clinic, published updated findings from a post-marketing safety analysis of over 25,000 TTFields patients. Dr. Mrugala’s analysis confirmed that TTFields therapy was well tolerated, and that no signs of additive systemic toxicity were detected in the patient population, corroborating the safety findings of the EF-14 trial. In April, in the journal BMC Cancer, Dr. Kumthekar of Northwestern, published a qualitative review of key factors driving patient adoption of Optune Gio for the treatment of GBM. Dr. Kumthekar’s team found that the two most influential drivers for adoption are knowledge of Optune’s proven survival benefit and the treating physician's opinion. Real world evidence from trials like TIGER &Dr. Mrugala and Kumthekar’s analyses, are important additions to the ever-growing body of studies supporting Optune Gio for the treatment of GBM, and they underline our commitment to generate and share data with physicians to support and broaden the adoption of TTFields. We are also focused on product development to improve the patient experience. We have rolled out our next-generation arrays in our key European markers, and patient feedback continues to be positive. We submitted a PMA supplement to the FDA in December, and expect a decision from the FDA later this year. After approval, we will commence US rollout. Our team is working on improvements to the digital experience for prescribers and patients, with the goal of providing dashboards to streamline patient starts and optimize usage and persistence. We believe our fully aligned commercial approach, supported by real world evidence and digital innovation, will help to drive strong commercial performance in the second half of the year. Our second key objective this year is the approval and launch of Optune Lua for the treatment of metastatic non-small cell lung cancer. Regulatory submissions have been filed, and we are engaged with authorities in all of our major markets. As a reminder, prior to our May earnings report, we had recently completed our 100-day meeting with the FDA, with no indication that the PMA will be referred to a panel. To date, a panel has not been requested, and our expectations remain unchanged. We eagerly await the FDA's decision later this year. In Europe, we are waiting for CE mark approval. The new MDR process in Europe has lengthened timelines, and we continue to engage with new reviewers at TÜV Rheinland, our EU-notified body. While the review process has taken longer than originally projected, our expected outcome has not changed, and we anticipate a final decision in the second half of 2024. Internally, our German and US lung teams are hired and are preparing to launch immediately following regulatory approval. We plan to treat patients in the US and Germany as soon as possible following approval using a named patient reimbursement process, with additional country launches expected next year. Non-small cell lung cancer represents the next major step forward in the NovoCure story, and we are eager to pursue this opportunity. Asaf will now review our clinical progress in the quarter.

As Bill mentioned, our third key objective this year is to deliver on the promise of our pipeline. This quarter, we made significant progress towards achieving that goal across our clinical programs in GPM, non-small cell lung cancer, and pancreatic cancer. We have reached a key milestone in our non-small cell lung cancer program. Last month, Dr. Minesh Mehta of Baptist Health South Florida, presented data from the Phase 3 METIS trial at the ASCO annual meeting in Chicago. METIS evaluated the use of TTfields therapy with best supportive care for the treatment of brain metastases from non-small cell lung cancer. METIS met its primary endpoint, demonstrating a median time to intracranial progression of 21.9 months in the TTFields arm compared to 11.3 months in the control arm. A positive trend in the majority of assessed quality of life scales was also measured, and there was no evidence of worsening cognitive function in the TTFields arm. Consistent with prior clinical trials, TTFields therapy was well tolerated, with no additive systemic toxicity. Final analysis of the METIS trial data is ongoing. We intend to publish the data in a peer-reviewed journal later this year. We have expanded our non-small cell lung cancer clinical program to include another registrational Phase 3 trial, LUNAR 2. LUNAR 2 will explore TTFields views with pembrolizumab, and platinum-based chemotherapy in first-line metastatic disease. This trial is open and enrolling at initial sites, and we are focused on expanding the clinical footprint. We are also in the process of opening a Phase 2 pilot trial, LUNAR 4. This trial will evaluate immunotherapy retreatment in metastatic non-small cell lung cancer. Turning to KEYNOTE B36, we are evaluating appropriate next steps for this trial, given its pace of enrollment and our focus on LUNAR 2. Our GBM program includes two additional registrational Phase 3 trials, TRIDENT and KEYNOTE D58. TRIDENT is exploring the use of Optune Gio, concurrent with chemo radiation. If TRIDENT is successful, we will work to expand our label and enable physicians to prescribe TTFields therapy several months earlier with chemoradiation rather than after chemoradiation, as is indicated today. TRIDENT is fully enrolled and will read out in 2026 once follow-up is complete. We are also preparing to open KEYNOTE D58. KEYNOTE D58 will explore the addition of pembrolizumab to TTFields and temozolomide in GBM, and builds upon the promising results of the - to the top Phase 2 trial conducted by Dr. David Tran. Finally, we are nearing an important readout in our pancreatic cancer program. In the fourth quarter, we expect to announce the top line data from the Phase 3 PANOVA 3 trial, which is studying TTFields together with gemcitabine and nab-paclitaxel for the treatment of first-line locally advanced pancreatic cancer. We are also currently enrolling patients in our Phase 2 PANOVA 4 trial. This trial is exploring the use of atezolizumab with TTFields, gemcitabine, and nab-paclitaxel in metastatic pancreatic cancer. Pancreatic cancer is a devastating diagnosis with five-year survival rates of 10%. We are eager to learn more about the potential benefits of using TTFields in the treatment of this aggressive disease. So far this year, we have reached one successful Phase 3 readout in METIS, and are hopeful for a second in PANOVA 3. We are awaiting potential regulatory approvals in lung cancer, and our solid commercial GBM business continues to fuel additional R&D initiatives. We are launching several new clinical trials this year that have the potential to expand TTFields use dramatically. We are pleased with our progress this year, and are eager to continue pursuing our goal to deliver the promise of the clinical pipeline. I look forward to providing further updates later this year. Ashley will now review our financial performance for the second quarter.

Thank you, Asaf. The second quarter was a period of consistent execution as we drive towards our three key objectives for 2024. our GBM business turned in the best quarter to date. We are laying the groundwork to launch in non-small cell lung cancer, and we continue to purposely invest in clinical research and product innovation. Walking down the P&L, we generated $150 million in Q2 net revenue, an increase of 19% year-over-year, and ended the quarter with 3,963 active patients on therapy, an increase of 11% year-over-year. The French market continues to be a tailwind to growth, and contributed $14 million in net revenue this quarter, with 369 active patients. We also continue to see a benefit in average selling price from improved approval rates in the United States. I want to call everyone's attention to two important points on the revenue model. Beyond the benefit in period, improved approval rates in the US generated a $5 million benefit and Q2 net revenues from prior period claims. In addition, we received $3 million in Q2 net revenues from a private payer in the United Kingdom where payments are not yet routine. We do not expect these two benefits, totaling $8 million, to recur, and would remove them from baseline expectations when projecting future revenues. Gross margin for the second quarter was 77%. SG&A expenses totaled $94 million in the quarter, a decrease of 5% year-over-year. This decrease was primarily driven by lower personnel expenses in support functions, which more than offset our continued investment in sales force expansion ahead of a non-small cell lung cancer launch. Research, development, and clinical trial expenses totaled $55 million in the quarter, in line with the same period in 2023. Our net loss for the second quarter was $33 million or $0.31 per share. We ended the quarter with cash and short-term investments of $951 million. This quarter, we saw positive adjusted EBITDA of $1 million, an increase of $28 million from the same period in 2023. While this was in part due to the one-time revenue contributors, we also saw material benefits from reduced operating expenses resulting from the strategic restructuring we undertook at the end of 2023. As we actively invest for growth, profitability remains a critical goal for us at NovoCure and something we are actively driving towards. I would like to close this morning by highlighting one of our Optune Gio users, Marino DiRienzo. Marino began using Optune Gio in January 2022 following debulking surgery. A father of twin adult sons, and a grandfather of three Marino, prides himself on living an active life and was eager to get back on his feet as soon as possible after his GBM diagnosis. Marino was able to integrate tumor training fields therapy into his daily activities quickly and was soon back on the baseball field with his sons and playing golf with friends. Marino is the embodiment of living each day to the fullest and a great reminder of what's at stake in extending survival for our patients. It is so fulfilling for our colleagues to be able to help Marino and his family, and I'd like to personally thank Marino for allowing us to be a part of his journey. With that, we will open the call for your questions.

[Operator Instructions] Our first question comes from Jonathan Chang of Leerink Partners. Your line is open.

Hi guys. Thanks for taking my questions. Can you give us an update on the LUNAR regulatory process in Germany and the US? You mentioned a new process in Europe, I believe. Could you give us additional color on that front? And finally, could you just confirm your current thinking on timelines in both Europe and the US? Thank you.

Sure, Jonathan. Good morning. This is Bill. So, as we stated in the prepared remarks, our expectations with respect to approvals in Europe and the US have not changed. The FDA timeline also remains unchanged. And importantly in the US, we still believe there will not be a panel. We have not received any indication as we mentioned in the 100-day meeting that we had or subsequently that the PMA will go to panel. In Europe, it's not a new process for us. It's a new process for Europe called the MDR process that has to some degree lengthened the timing from submission to approval for everyone in the medical device space. Initially, we had projected an approval in the first half. We're actively interacting again, as we mentioned, with our notified body, and we now expect that to occur in the second half. So, that's the only change.

Understood. Are you able to elaborate on the NDR process? Are there - like what are the boxes that need to be checked?

Yes, so we never talk about the specific back and forth other than to say it’s constructive, and again, we don't expect - we still expect the same outcome. We just expect it to be a little later in the second half.

Understood. Thanks for taking my questions.

Thank you. Our next question comes from Jason Bednar of Piper Sandler. Your line is open.

Hey, morning. Nice quarter everyone. A couple of questions to start from us. We wanted to focus first on maybe the commercial side. The US, active patient number improved sequentially for the first time in a year. That was good to see. Can you talk about the sustainability of this type of improvement? How do you build upon that going forward? Or should we more simply think of this active patient number remaining around 2,200 patients or so going forward? And then Ashley, I think you also said that your payer approval rates continue to improve in the US. How would you have us think about US revenue in the context of that comment? Does your revenue algorithm change near-term or revenue per patient change near-term and how we calculate and model that out?

Hi Jason, this is Frank. Thank you for the question. Appreciate the note on the commercial performance. Yes, we are first - just looking globally before I come to the US, we're really pleased that we've now approached 4,000 patients on therapy worldwide, and that is a high watermark for us. With respect to the US, what we have been able to do is to return the active patients to sequential growth from year-end, as you noted. And as a reminder, at the end of last year, we did realign our organization so that our teams have a focus, our commercial teams have a focus, not just on driving demand as measured through prescriptions coming in, but really have a comprehensive plan to then convert prescriptions to start and then ensure that the patients can stay on therapy to enjoy the full benefit of therapy. So, I think what you've seen in the numbers the last two quarters is our ability to tighten up operations and to really ensure that we do maximize the value of each prescription coming through and maximize the benefit to the patient. As you know, we don't give guidance looking out into the future. So, I won't comment specifically on where we see this number going, but I'll remind you as always that we do believe there are more patients who can benefit from therapy, and as an organization, we’re committed in all of our markets to ensuring that we drive growth and help the most number of patients possible.

Great. And Jason, this is Ashley. I'll jump in with some commentary on the net revenue per patient. You heard us clearly call out $8 million from this quarter's net revenue, which we believe essentially are - I don't like the one term in nature because fundamentally is improvement in approval rates is recurring, but the benefit in the quarter, we get both the catch-up benefit and the end quarter benefit. If you take that $8 million out of the Q2 net revenues, you can then use that net revenue per active patient number projecting forward in the model. And specifically in the US, which is where you see the improved benefit from the approval rate, if you take that $5 million out, you'll see the improvement. It's about 200 basis points year-over-year, and that is sustainable. We do believe that the improvements there will endure, but you don't get both the catch-up and the improvement every quarter moving forward.

Got it. Okay. That’s helpful. Thanks, Frank, and thanks Ashley. One clarifying follow-up from the prior question. Bill, did you say that CE mark is now expected later in the second half, so basically implying that it's a fourth quarter target? So, just wanted to check on that, if I heard that right. And then just wanted to see if you have any updated thoughts or perspective on the regulatory path for METIS, just how you're going to proceed there. Thank you.

Sure. So, I did not say late in the second half for CE mark. And then Asaf, maybe you want to comment on the next steps for the METIS submission.

Yes, thank you. So, we are right now evaluating and finalize the all analysis and preparing for submission, and we are planning to do it in the near future. And then we'll come back, and we'll let everyone know exactly which department in the FDA, but we are working on it.

Maybe to follow up quick, I mean, is this something we should expect submission before year-end? Is this a 2025 dynamic? Just trying to understand as we kind of pencil things out from a milestone standpoint where METIS is going to land.

So, our goal is to try to finalize this year.

Okay. Thank you.

Thank you. Our next question comes from Larry Biegelsen of Wells Fargo. Your line is open.

Good morning. Thanks for taking the question. Just a follow up on that last response. Asaf, when you say our goal is to finalize this year, I assume just - maybe this is just a little bit of a language barrier, but when you say finalize, you're saying we plan to submit the METIS application in 2024 in the US and Europe. Is that what you meant by finalize this year?

Yes.

Okay. And maybe just to follow up on METIS, what are you guys hearing from clinicians? How do they see tumor treating fields fitting into the treatment paradigm? And I had a follow up.

Yes, Larry, this is Frank. Thank you for the question. What I can say is that we unveiled the data from METIS at ASCO in in June, and we really saw across the board strong interest in understanding the data. I think I'd also just share the anecdote that at ASCO this year, we saw just broader awareness of tumor treating fields across all of the indications where we've released data. And I think really seeing that strong interest both from the radiation oncology attendees, but also from the medical oncology attendees strong interest, really focused on the fact that the delay in time to progression is a clinically meaningful endpoint in terms of helping patients with brain met. So, really pleased with what we saw at ASCO this year and we're encouraged to move forward with clinicians to help these patients

And the treatment paradigm, what are you hearing, where it will fit in?

Sorry, Larry. I'm not sure I fully understand the question, but I think in terms of sort of details on what drugs may be used concurrently or the exact specific patients, that's - some of the analysis is still ongoing from the trial, and we'll update you as it becomes available.

Okay. And then on B36, can you - you provided a little bit of an update in the prepared remarks there. How many patients have been enrolled? What are the options for the next steps? And how does that impact how you think about enrollment of LUNAR 2? I guess it's taken a long time to enroll B36, so I guess the concern is that it's going to take equally long to enroll LUNAR 2.

This is Nicolas. Thank you very much, Larry, for that great question. And I think something very, very important that B36 is not loaded tool in a lot of different aspects. So, what we said is that we are just evaluating appropriate next steps for B36. Now, let me remind you what B36 is. It’s a Phase 2 study in first-line non-small cell lung cancer with monotherapy of pembro. And just to remind you, monotherapy pembro is 5% of patients in the US, and it's a trial just being run in the US, and again, it's a Phase 2 trial. Now, Phase 2 trials have the characteristic to lead us for Phase 3 trials and inform us how we need to run Phase 3 trials. Now, LUNAR 2 is a Phase 3 pivotal trial that is exploring TTFields in pembro and pattern based chemotherapy, which is one of the main foundation in US patients at least, about 95%. So, we are having a very, very, very different situation here.

I got it. Hey, just one, maybe if I could sneak in for Ashley. With the multi-tranche financing, are you now more likely to meet the 2025 convert using cash now? Can you be more specific on the planned usage of the financing beyond the convert? Thank you.

Yes, no, we're quite confident that we now have the strengths of the balance sheet we need to pay down that convert. So, I don't anticipate any challenges there.

Okay. Great. Thanks for taking the questions.

Thank you. Our next question comes from Jessica Fye of J.P. Morgan. Your line is open.

Hey guys, good morning. Thanks for taking my questions. You talked about France as a nice growth contributor and broke it out for 2Q. Can you tell us what France sales were in the first quarter, and talk about how we should think of its contribution in the back half? And then following up on the earlier comments on US net price, I think I heard sort of a clean 200 basis point year-over-year improvement in US net selling price that's sustainable. Is that it and we'll eventually annualize over that and be done, or is there more room to run on US net selling price? And if so, how much? Thank you.

Yes, Jessica, this is Ashley. I can jump in there with the specific modeling questions, and then let Frank follow up with any color on France. In the first quarter, France was about $10.5 million, and you saw that second quarter $14 million. It's always a nice milestone when you cross into being a material market. So, France will be broken out from here on. And again, congratulations to the entire French team for that. It's really - and also milestone. But so we do continue to see growth there. Now, growth will moderate as that market matures, but it is approaching a German-like size market now, and we expect it continue to perform as we move forward. If we move over to the US price, I'll challenge that team always to get better. And I know I have a team there that's focused in market on doing it, but we're approaching approval on almost all patients in the US now. So, there is not much more room to grow in our commercial payers. This is a very sustainable improvement. We think we can hold it. We're always after kind of incremental bits that we can get, but I want to manage expectations that net price in the US now is a reasonable net price to model moving forward.

This is Frank. I'll add just a bit of color on the business in France and repeat what we said during the prepared remarks, which is, France is really our blueprint for success in launching. we prepared the market with a team of both the business teams, the medical teams. We had clinical trials open in the market in advance of actually getting approval and getting reimbursement. And I think it is - we are very pleased with the results, and we're quite frankly ahead of schedule of where we expect it to be in France in terms of market penetration. It's exciting that we're now crossing over a little bit more, five quarters, a little bit more than a year into the launch and still seeing the excitement from our clinicians and also from the patients who are now coming a year into the therapy. So, it's really our blueprint for success in the future.

Thank you. Our next question comes from Vijay Kumar of Evercore ISI. Your line is open.

Hey guys thanks for taking my question. A couple of modeling-related questions. France annualizing north of $50 million. Is that - how do you size that market opportunity? Is this expected to continue? It's a strong sequential trends in the next year in - for comparison, like what was France revenue base in fiscal 2023?

Yes, I mean, I would anchor you to say, Vijay, France is German-like in its sizing, and we expect those to be our two largest European markets. And then as we look ahead, we do expect to be able to begin to bring on, in upcoming years, additional big pie markets which will add more revenue. So, it is German-like in its opportunity. And yes, we continue to expect growth out of all of our markets, I will say, as it ramps up. It's growing off of a solid base, and of course we have to keep that in mind, but it is a market we expect to be Germany-like in size.

And sorry, on the revenue base in fiscal 2023, which was France in fiscal 2023?

I don't think we broke that out. In 2023, I will tell you - yes, I mean, if you look at the other EMEA markets, which we do break out on our Q, Vijay, the vast majority of it is France.

Understood. And then how does reimbursement work now, France? When I look at that net patient revenue in that other EMEA region, like that's tracking about Germany. And when we look at Germany, I think once you had national payments kick in, rates got cut. So, is France - is there any risk of future updates for reimbursement rates? Or is this all said and done?

Yes, so the short answer is not expected, Vijay. Now, the longer answer in there, this is an important distinction, is that we have two markets where we go at risk of reimbursement on a named patient basis on launch. Those are US and Germany, and you hear us in lung, that's where we will launch. And the other markets, it’s national reimbursement, and we do not launch until we have reimbursement secure. So, that is how we handled France. That is how we handle all other markets outside of the US and Germany, so that revenue is stable and durable.

Understood, that's helpful. Maybe last question on PANOVA pancreatic cancer, can you maybe high level compare, contrast, like you've had several trials, GBM, metastatic brain cancer, NSCLC. When you look at pancreatic cancer, is there anything different about this disease state when you compare with the others, and when you've looked at the early experience - early data on pancreatic side, how does that compare versus other disease states? Anything that sets apart pancreatic opportunity for you guys?

Sure. So, Vijay, it’s Bill. As we've noted in the past, tumor treating fields provides the best opportunity to extend survival when it's used early in the patient journey. In many cancer types, and this was true in non-small cell lung cancer, just because of the way the field has evolved and we need to start our trials in later lines when the patients are sicker, in the case of PANOVA 3, that trial was designed as a first-line trial. So, number one, that is positive with respect to tumor treating fields therapy. Secondly, we know that we are a regional local therapy and that we - and we saw this in the Phase 2 PANOVA data, that when we can treat the full extent of the disease, and that means diagnosing it earlier when it has only spread locally, we have the best outcomes. And again, in this trial, PANOVA 3, this trial was in the about 50% of the patients who receive a pancreatic cancer diagnosis who have locally advanced therapy. So, because it's first-line and because it’s in the locally advanced population, we think the trial was well designed, and if we had designed it today, we would've designed it with the same design. So, we're all really looking forward to reporting out the results later this year.

That's extremely helpful comments, Bill. Maybe one last follow-up on that. When you say given it's a local regional treatment, does that mean tumor needs to be in fifth - early stage, stage one, stage two cancer, as against stage three? And when you say 50% of patients, so at the time of diagnosis, are 50% of pancreatic cancer cases in the stage one, stage two?

Yes. So, let me - our understanding is that in the US, when pancreatic - remember, we're not all being scanned for pancreatic cancer every year, and that about 10% of patients are diagnosed usually by accidental findings when they have pancreatic cancer that is operable, and they will receive surgery. The remaining 90% are diagnosed past the point when it's operable. And of those, some, and there are different numbers, but 35%, 40% are again, diagnosed when it has expanded locally. And the remaining 40%, 45%, it is already systemic and metastatic throughout the body. So, PANOVA 3 is focused on those patients where the - that are not - one, not operable, but two, the pancreatic cancer has not spread into the bones and the brain and the rest of the body.

That's helpful. So, the enrollment criteria, we're looking at those cases, the 10% accidental diagnosis and the 35%, 40% for local, correct? That's the patient enrollment?

No, the 35% to 40%. So, the patients who were not operated on and where the disease is - again, the term of arc here is locally advanced.

Fantastic. Thanks, guys.

Thank you. Our next question comes from Emily Bodnar of H.C. Wainwright. Your line is open.

Hi, good morning. Thanks for taking the questions. I wanted to follow up on the KEYNOTE B36 study. Is there anything that you've seen in that study so far in the patients you've enrolled that kind of gives you more confidence in LUNAR 2? And then just kind of following up on other markets for Optune, are there - what kind of other countries are you looking at which you think could be similar in size to like the France and Germany markets so far? Thanks.

I'll take the first part of the question, and I think we usually do not comment about findings on running trials, as far as I understood your question. Maybe I misunderstood?

I just meant if you have seen anything that gives you confidence in LUNAR 2 based on the KEYNOTE B36 study.

As I said before, B36 and LUNAR 2 are two completely different trials, and that does not in any way change the confidence I have in LUNAR 2.

Excellent. And with respect to new markets, we have commented before that up next on the horizon, we are working in both Italy and Spain, which are - in each country, it's a region-by-region approach to gaining reimbursement with hospitals and payers. And we're making progress in both markets, and we think of Italy and Spain together as being our next potential France in terms of a market.

Got it. Thank you for taking the questions.

Thank you. I'm showing no further questions at this time. I'd like to turn it back to Bill Doyle for closing remarks.

We entered 2024 with three key objectives for the year and also to position us for the future. Those were to grow and return to growth in our GBM business, to launch our indications in the US and Germany in non-small cell lung cancer, and to deliver on the promise of our clinical and product development pipelines. We're very pleased this morning to be able to report progress across all three, and we look forward to the balance of the year where we have significant catalysts ahead. So, thank you for your continued interest at NovoCure. Thanks for all the NovoCure employees who are listening for your dedication. It's an exciting time and we will be here for Q3. Thank you.

This concludes today's conference call. Thank you for participating and you may now disconnect.