Good day. Thank you for standing by. Welcome to Novocure's Second Quarter 2025 Earnings Conference Call. Please note that today's conference may be recorded. I will now hand the conference over to your speaker host, Ingrid Goldberg. Please go ahead.

Good morning, and thank you for joining us to review Novocure's second quarter 2025 performance. I'm on the phone this morning with our Executive Chairman, Bill Doyle; CEO, Ashley Cordova; and CFO, Christoph Brackmann. 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 on the 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 statements, 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 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 10-Q 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. At Novocure, our mission is to extend survival for patients diagnosed with some of the most aggressive forms of cancer through the development of Tumor Treating Fields therapy. This quarter, we grew our commercial business and advanced our efforts to bring Tumor Treating Fields therapy to new patient populations. With the first half of 2025 complete, I am pleased to report we are making good progress on our clinical, regulatory and commercial milestones. This morning, we will provide detail concerning recent PANOVA-3 data presentations at two key medical conferences, and we will review the next steps for our upcoming regulatory submissions of PANOVA-3 and METIS. We will also discuss our commercial performance in the quarter. And to close, we will review our quarterly financials and open the line for Q&A. While our commercial teams pursue greater penetration and improved indications, we are working intensely to gain approvals in new indications. This quarter, we took important steps towards approval in pancreatic cancer. The five-year survival rate for patients diagnosed with pancreatic cancer is only 13%, and pancreatic cancer is often associated with debilitating pain for which patients are quickly escalated to high doses of pain medications. Addressing these needs sets a high threshold for success in pancreatic cancer trials. We are pleased the PANOVA-3 trial proved the benefit of TTFields therapy together with gemcitabine and nab-paclitaxel for both of these endpoints. In May, we had an exciting presence at the ASCO Annual Meeting, where data from PANOVA-3 were presented during the Saturday evening pancreatic cancer plenary session. The PANOVA-3 findings were concurrently published in the Journal of Clinical Oncology, or JCO, and earned inclusion in Best of ASCO, which will be highlighted at regional ASCO meetings throughout the year. As a reminder, the PANOVA-3 intent-to-treat population in unresectable locally advanced pancreatic cancer patients treated with TTFields together with gemcitabine and nab-paclitaxel saw a median overall survival of 16.2 months, 2 months greater than the control arm. In the modified intent-to-treat population of patients who received at least one cycle of therapy, patients saw an even greater survival benefit of over 3 months. TTFields patients also saw a benefit in pain-free survival with a median time to increase pain in the intent-to-treat group of 15.2 months versus 9.1 months in the control group. Following the presentation, Dr. Brian Wolpin of Dana-Farber, who played the role of objective reviewer, said TTFields plus gemcitabine and nab-paclitaxel would be an appropriate option for standard of care. Dr. Eileen O'Reilly, of Memorial Sloan Kettering Cancer Center, commented in the JCO editorial that Tumor Treating Fields together with gemcitabine and nab-paclitaxel serves as a new standard paradigm in this patient population. These physicians, from two of the top academic institutions in the United States, are leaders in the treatment of pancreatic cancers and notably, are new to the use of TTFields therapy. The PANOVA-3 results earned a second late-breaking podium presentation at the ESMO GI Annual Congress, where the quality of life data from PANOVA-3 was described in greater detail. Patients treated with TTFields in gemcitabine and nab-paclitaxel saw improved global health status, significantly improved deterioration-free survival for pain and pancreatic pain, and significantly increased time to commencement of opioid use. PANOVA-3 showed TTFields' ability to extend survival, preserve quality of life, and delay many of the worst symptoms associated with pancreatic cancer. These clinical outcomes underscore the importance of TTFields therapy for these patients. And given the extremely limited options for pancreatic cancer patients, the feedback from physicians, KOLs and advocacy groups following these presentations has been overwhelmingly positive. Our teams are working on the FDA PMA submission for pancreatic cancer. Earlier this month, we met with the FDA for a pre-submission discussion in anticipation of submitting our full PMA package for FDA review. We expect to file the PMA with the FDA in the third quarter. Concurrently, we are working on the regulatory packages for Europe and Japan and expect to file these prior to year-end. Brain metastases from non-small cell lung cancer is our next potential indication. The METIS trial met its primary endpoint demonstrating a statistically significant improvement in the time to intracranial progression for patients treated with TTFields therapy in supportive care compared to patients treated with supportive care alone. Following our initial data presentation at ASCO last year, the routine process of cleaning and qualification of the data was completed. The final analysis of the fully cleaned and qualified data set confirmed the statistical significance of the primary endpoint, improvement in time to intracranial progression with updated numerical outcomes. Patients treated with TTFields therapy and supportive care exhibited a risk reduction of 28% with a median time to intracranial progression of 15 months compared to 7.5 months in patients treated with supportive care alone with a p-value of 0.044. We intend to present the updated final clinical results at an upcoming medical conference early this fall and have submitted the manuscript for publication. Our teams are also working on the FDA PMA submission for brain metastases from non-small cell lung cancer. We submitted the first two PMA modules in April. We will be meeting with the FDA this quarter prior to submission of the final clinical module, which is on track for submission later this year. For both PANOVA-3 and METIS PMA filings, we expect the 9- to 12-month review following acceptance by the FDA with potential approvals and launches to follow in 2026. Our next clinical data readouts are anticipated in the first half of next year. The Phase III TRIDENT trial in newly diagnosed GBM studies the potential benefits of initiating TTFields therapy several months earlier in the patient's journey, concurrent with chemo radiation rather than after chemo radiation. PANOVA-4 is a Phase II trial that adds the immunotherapy atezolizumab to TTFields, gemcitabine, and nab-paclitaxel in the metastatic pancreatic cancer setting. Both trials are fully enrolled, and we look forward to sharing updates in the near future. With that, I'll turn the call over to Ashley to review our commercial progress in the quarter.

Thank you, Bill. We are squarely focused on execution, and I am proud of what the team has delivered so far this year. We have reached multiple milestones on our path to bring Tumor Treating Fields to more patients and have additional catalysts on the horizon. One of our key areas of focus is the Optune Lua launch in non-small cell lung cancer. In the second quarter, we received 121 prescriptions for non-small cell lung cancer, 106 in the U.S. and 15 in Germany, which launched following receipt of the CE Mark on April 22 of this year. We ended the period with 137 Optune Lua patients globally, 94 from non-small cell lung cancer and 43 from MPM. Importantly, we are beginning to build reimbursement experience and recognized $2.4 million in net revenues from Optune Lua in the quarter, of which $1.1 million was from non-small cell lung cancer. We are pleased that many of the launch themes we described last quarter have continued in the U.S. In Q2, we had 75 unique prescribers of Optune Lua, 41 of those physicians were entirely new to Tumor Treating Fields therapy, while 34 had previously prescribed. This shows a healthy mix of physicians recognizing the clinical benefit and trying Tumor Treating Fields for the first time and repeat prescribers. Additionally, we continue to see the full label utilized with 58% of prescriptions written together with immune checkpoint inhibitors and 42% with docetaxel. Importantly, over 93% of the patients prescribed Optune Lua with an ICI had previous ICI exposure. Validating the strong demand and physician comfort with continued ICI use post platinum failure. One theme we have observed since launch is that prior physician experience to Tumor Treating Fields matters, whether that's firsthand prescribing Optune Gio and GBM or Optune Lua for MPM or through access to a colleague with Tumor Treating Fields experience. Physicians are excited by the clinical outcomes seen in the LUNAR trial. However, some physicians have questions on how to incorporate Tumor Treating Fields into their daily practices. We answered the same questions when we introduced Tumor Treating Fields to the GBM community. With this in mind, we have been cultivating peer-to-peer connections. So practitioners new to Tumor Treating Fields can access physicians with years of Optune Gio experience. We have seen promising feedback from these peer-to-peer conversations so far and believe continuing to foster these relationships will pay dividends as new indications come to the medical community in the future. We have also learned that many physicians view the best use case of Optune Lua as a replacement for platinum chemo at the first sign of radiological progression rather than explicitly a transition to second-line treatment. This represents the smoldering progression population we have referenced throughout our market research. With this in mind, we are tweaking the physician messaging around Optune Lua to a post-platinum option rather than explicitly second-line therapy to better align with the way doctors view the patient treatment journey. Moving outside of the U.S. In late April, we received the CE Mark for non-small cell lung cancer and launched in Germany with 15 prescriptions in the quarter. We are pleased with the early interactions with prescribers especially pulmonologists, who take an outsized role in non-cell lung cancer treatment in Germany compared to the U.S. Interest from physicians has been high, and our sales teams have been able to get on calendar swiftly. We also see similar dynamics of broad label usage and prior ICI exposure in Germany as we have seen in the U.S. Japan is the next market where we expect to launch Optune Lua for non-small cell lung cancer. We are actively engaged in discussions with Japanese regulators and are hopeful we will have approval in hand in a matter of months. We believe Japan will be a strong market for non-small cell lung cancer, as incidence rates are higher in Japan than in many of our other major markets. Also, single-payer dynamics can expedite the revenue ramp timeline once terms are agreed, similar to what played out in our GBM launch in France over the past two years. We are doing everything in our power to expedite the approval and reimbursement processes in Japan and look forward to providing more updates later this year. The next step in non-small cell lung cancer will be translating demand into topline revenue growth. We have had some early success in case-by-case reimbursement submissions with over $1 million in cash recognized this quarter from non-small cell lung cancer and are actively engaged with both public and private payers in the U.S. to reach reimbursement terms as soon as possible. Private payers are focused on updated guidelines from NCCN. The NCCN lung cancer panel met earlier this month, and we expect updated guidelines to be published this fall. On the public side, we have submitted our package for LCD reconsideration and are now waiting to hear back from the MAX. Once an updated LCD is released and the public comment period is complete, the MAX will issue a coverage decision. There isn't a statutory timeline for review, but we estimate the review will take approximately 9 to 12 months. Turning to our GBM business. We continue to march higher and finished the quarter with 4,194 Optune Gio patients on therapy, a 7% increase compared to last year. Each of our key markets, the U.S., Germany, France, and Japan increased their patient count year-over-year with all our ex-U.S. markets experiencing double-digit growth. We are also starting to see early reimbursement success in Spain. While the Spanish market is fragmented, we are encouraged by the progress. One of the avenues to drive GBM growth is ongoing evidence generation. This quarter, an independent retrospective study from the Mayo Clinic was published in the Journal of Clinical Neuroscience. This study followed 374 GBM patients treated at Mayo Clinic locations between 2014 and 2023. Academic centers have not historically been the highest adopters of Tumor Treating Fields therapy, so it's notable to have a leading research institution like Mayo Clinic conduct this retrospective study. In this real-world study, patients treated with Tumor Treating Fields therapy demonstrated a 2-year survival rate of 58% compared to just 41% in patients not treated with Tumor Treating Fields. The Mayo study is another example of confirmatory data and reaffirms why Optune Gio is a foundational therapy for GBM patients. We believe more real-world use data from leading research centers like Mayo will be an important lever as we seek to increase adoptions in academic centers. Before I turn the call over to Christoph to review financials from the quarter, I'd like to express my gratitude to the Novocure team for their hard work during this important year. The fundamentals of our business continue to strengthen each quarter. Q2 marks the 11th consecutive quarter of active patient growth. During that time, we've had three positive Phase III readouts in new indications, launched our non-small cell lung cancer indication in the U.S. and Germany, and introduced new product enhancements to improve therapy delivery and experience for patients and physicians. Each of these achievements requires the tireless dedication of our team, and I want to applaud your efforts as we look ahead with urgency to extend survival for many more patients with some of the most aggressive forms of cancer. This is a pivotal period for Novocure with an established indication in GBM, the ongoing launch in non-small cell lung cancer, and two additional launches within reach. The steps we take this year set us up for continued growth in both the near and long term. With that, I will turn the call over to Christoph.

Thank you, Ashley. We continued our positive momentum this quarter with net revenues of $159 million, an increase of 6% from the second quarter of last year. This increase was primarily driven by year-over-year active patient growth of 7% in our GBM franchise, including double-digit growth in all our international markets. The favorable year-over-year impact from exchange rates was $3.8 million in the quarter, offset by lower one-time benefits from prior period claims. We collected $2.4 million from Optune Lua claims in the quarter, including $1.1 million from non-small cell lung cancer collections in the period compared to $1.5 million and $0.7 million in Q1. As a reminder, we recognize revenue by applying estimated future collection rates at the time of billing per U.S. GAAP standard. It will take several quarters for us to build a track record of collections to support an estimated rate to recognize revenue at billing. In the meantime, non-small cell lung cancer collections reflect approvals and positive outcomes from appeals in the quarter. Gross margin for the second quarter was 74% compared to 77% in Q2 of 2024. This reduction was primarily driven by the rollout of our HFE array and the continued launch of non-small cell lung cancer prior to the establishment of broad reimbursement. These headwinds are consistent with previous periods, and we expect them to decrease as we lower the production cost of the HFE array and establish reimbursement in non-small cell lung cancer. We only had a minor impact from tariffs in the quarter of $1.3 million driven by a reduction in pre-tariff inventory in Q2. While there is still considerable uncertainty around future tariffs for imports into the U.S., we currently do not foresee major changes from our expectations of last quarter. Our most significant exposure remains the import of arrays into the U.S. from Israel, with lesser potential impact from imports from Mexico and Europe. Our current estimates indicate that the full year P&L impact is up to approximately $7 million, subject to timing, rates, and exemptions from these tariffs. We are continuing to actively explore avenues to minimize our tariff exposure where possible. Moving to operating expenses. Our research and development costs in the quarter were $56 million, an increase of 2% from the second quarter of 2024. We do not expect R&D expenses to take a material step up this year as we ramp down spending on some large Phase III trials and ramp up spending on others. Sales and marketing expenses in the quarter were $57 million, an increase of 1% from Q2 of last year. Incremental launch expenses for our non-small cell lung cancer indication were mostly offset by lower stock-based compensation expenses. Our thoracic sales forces in the U.S. and Germany are fully staffed and reflected in our year-to-date operating expense. Looking ahead, we expect modest incremental expense primarily for marketing and in preparation for launch in additional countries. G&A expenses for the quarter were $44 million, an increase of 17% from the second quarter of 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional service expenses to support the non-small cell lung cancer launch and general company build-out, particularly on the enterprise technology side. Net loss for the quarter was $40 million with a loss per share of $0.36. Adjusted EBITDA in the quarter was negative $10 million. Our cash and investment balance at the end of Q2 was $912 million. We have $560 million in convertible notes that will come due later this year, which we intend to retire with cash on the balance sheet. Additionally, we have given notice of intent to draw the second of four tranches of $100 million each from our credit facility, which will close on September 26, 2025. According to the terms of our credit facility, we have an obligation to draw the first two tranches. With the cash and short-term investments currently on the balance sheet and funds available through our credit facility, we believe that we have the capital necessary to retire the outstanding convertible notes and bridge to our next revenue streams in new indications. As Ashley said earlier on today's call, this is our 11th straight quarter of active patient growth. With one launch ongoing and two more on the horizon, we are continuing to build momentum and deliver on the promise of our innovative therapies. We believe we have the talent, infrastructure, and financial assets in place to bring new indications to market, gain reimbursement, and reach profitability in the years to come. I would like to thank you all for joining us on this journey, and we look forward to updating you on our progress later this year. I will now turn the call back over to the operator for questions.

The first question is coming from Larry Biegelsen with Wells Fargo.

So Ashley, the second quarter non-small cell lung cancer prescriptions and patients grew less quarter-over-quarter in the second quarter than Q1. And the number of prescribers actually went down. The U.S. prescriptions increased by only 14 sequentially. So why was that? And how should we think about the ramp the rest of the year? Should we be thinking about the low end of the $5 million to $10 million range that you discussed before for 2025? And I had one follow-up.

Sure. Thanks for the question, Larry. I'll start off and then I'll ask Frank to add some additional color. So I think the theme you should take away is that the launch is on track. We're pleased with the themes. What we're seeing is kind of a consistent ability to get into market and to educate these positions. And I would say we actually feel like the launch is progressing as we'd expected, and I'm quite comfortable with where expectations are on a full-year basis. And with that, I'll ask Frank to add some additional color.

Yes, Larry, I would echo the note that we're pleased with the overall theme of the launch. And specifically, what I would say is that you're seeing repeat prescribers. And we've seen, in particular, prescribers who came on right at the launch are now really building volume with their own practice. In some instances, we've even seen physicians, and this is common for devices, have moved towards marketing access to the device in their practice in social media. And so I think we're consistent with the device launch, we're getting physicians comfortable with the device, we're getting into their practice, and we're building volume.

That's helpful. One follow-up on the METIS data. Bill, how different were the numbers that you disclosed this morning from what we saw at ASCO last year? And why was it another analysis required?

Sure. Let me remind everyone about the METIS trial. In non-small cell lung cancer, brain metastases are a significant indicator of patient decline. Approximately 25% of patients are diagnosed with brain metastases at the time of their cancer diagnosis, and at least another 25% may develop them later. This creates a substantial unmet need in non-small cell lung cancer. The current standard treatment includes stereotactic radiosurgery followed by supportive care. In the METIS trial, we investigated the impact of adding tumor treating fields to supportive care after stereotactic radiosurgery. The primary endpoint of this study was progression. Unlike our other trials, which focus on overall survival as a very specific and binary endpoint, this trial utilized radiographic reviews for the analysis. Initially, a first read is presented, and then a final dataset is given after standard data cleaning. We are pleased that the data remains statistically significant and clinically meaningful.

And our next question coming from the line of Jason Bednar with Piper Sandler.

I'll double-click first on the response to Larry's question on lung. Anyway, feel free to answer, but do you think there's something that you can do that increases the slope and the adoption curve and helps take those scripts and active patients higher than where we're at today? I mean, we now have a couple of full quarters of data points here to work with. I hear you on the physician experience in med tech-like launch, but maybe just talk about how you're thinking about the progression of uptake and kind of maybe some of your own expectations as we look out balance this year and into future years and feel free to respond to the U.S. and Germany as well.

Yes, this is Frank. Thank you for the question. I'll begin by highlighting that there is a significant unmet clinical need for second-line treatment in Stage IV non-small cell lung cancer. Physicians are not satisfied with the current treatment options, which include docetaxel and docetaxel plus ramucirumab. We believe there is a substantial market opportunity, evidenced by the fact that 90% of our patients have previously received immune checkpoint inhibitors. Physicians are willing to use our treatment for this entire patient population, accessing both aspects of our label. Regarding our strategy to enhance the launch as we gain experience, we are focusing on refining our marketing messages and targeting the right population. A considerable portion of patients begin platinum therapy but are unable to continue due to side effects or adverse events, even if their disease has not fully progressed. Sometimes, it may only be a clinical progression where the patients are not feeling as well as before. We intend to emphasize that once patients discontinue platinum therapy, they become eligible for Tumor Treating Fields. We believe this approach will lead to successful outcomes, as we've observed an increase in patient volume as physicians respond positively to this strategy. We are optimistic about our potential for growth.

All right. Helpful. And then one other one, looking ahead to TRIDENT. This is a bit of a different trial. You're trying to extend the wear for the indication where you already have approval. I don't want to put the cart before the horse here. But can you talk about maybe the regulatory and payer path that we should have in mind when we look ahead, if we make the assumption that this is a successful trial, is this a PMA supplement route you'd be pursuing? What kind of hoops do you think you'd have to jump through with payers? Anything like that would be helpful as we look ahead to early next year?

Thanks for the question, Jason. This is Ashley. I want to remind everyone that TRIDENT is focusing on patients with newly diagnosed GBM, examining the overall survival benefit of initiating Tumor Treating Fields earlier in the treatment process alongside radiation instead of after chemotherapy, which aligns with our current label. We expect trial results in the first half of next year, and we're eager to see the data, as it could significantly enhance survival rates and position the therapy earlier in the treatment pathway, offering potential benefits in treatment duration. It's premature to discuss specifics regarding regulatory and reimbursement implications, as these will depend on the data. However, I believe this will be less complicated than a De Novo PMA since it involves an earlier application of our existing label. This principle would likely extend to payer dynamics as well. The same coverage policies for newly diagnosed patients would need to factor in this data, and I think it presents a more manageable hurdle compared to pursuing a new indication. While it's too soon for details because the data will inform those discussions, we are very hopeful and excited about this trial.

I will wait on that. If I could ask one more question about the NCCN guidelines, how do you believe categories 2A, 2B, and 3 will ultimately affect commercial coverage?

Yes, it's probably too soon to predict outcomes, but anything that can improve our category rating would be beneficial. I believe simply adhering to the guidelines in our calculations is already a step forward. With more publications, we will continue to advance within those guidelines. It's crucial to understand that your starting point does not determine your endpoint. The volume of publications is significant here, and like everyone else, we are looking forward to the updated guidelines being published later this fall.

Next question coming from the line of Vijay Kumar with Evercore ISI.

I had two questions. First, regarding ASCO PANOVA, could you provide insights on the reception at ASCO? Specifically, I would like to hear about the physician feedback and how it compares to your previous podium presentations at ASCO.

Maybe I'll start as the longest-serving member of the team here. Vijay, our very first presentation at ASCO, which was the EF-11 data, no one came to the presentation. EF-14 was very well attended. But there was little understanding about the mechanism of action and just a lot of questions about what is this new therapy. This was by far the most exciting ASCO that I have attended in 25 years. We were front and center on the podium in the plenary session. We were included with all of the latest presentations. Our discussion, we mentioned this in the script, who was unfamiliar previously with Tumor Treating Field therapy, Dana-Farber physician concluded that our therapy should be standard of care. And ours was the only presentation for which that conclusion was delivered. The others were more study of this, more study of that, the side effects don't seem to justify the benefit. And then we follow that with a discussion with our lead investigator, who was a very effective presenter and was a very effective advocate for the standard of care use of the therapy. And that was reflected in the, what I'll call, the talk on the floor. And maybe I'll turn it over to Frank and Ashley because we were all there but to reflect on some of that I'll call the hubbub, but this is highly anticipated at this point.

The only additional point I want to make, Vijay, is that we were featured on the front page of the ASCO daily news on Sunday, which was very exciting and new for us. This momentum carried into the discussions. ASCO is just one event, and while it's wonderful to see that energy and enthusiasm, it’s crucial for that to extend into ongoing conversations with physicians. I attended ESMO GI in Barcelona last month where we presented the quality of life data, and it was really enjoyable to participate in these congresses when physicians approached us already familiar with the data, enthusiastic about it, and discussing next steps and future possibilities.

That's helpful. Then maybe one for Christoph. On the revenues here. I think your 10-Q had some details on revenues recognized from performance obligations for prior period service rendered. I know there is a CMS backlog payments one-offs, which comes in from time to time. What was CMS back there? Is that included as part of this performance obligation? Or how should we think about this CMS versus non-CMS? Is this more of a recurring feature? Or should we think of it as a one-off?

Yes. So I would think of it as a recurring feature. As I said also in the script, we recognized revenue by applying estimated future collection rates. And we do this by portfolio for our commercial portfolio for Medicare, for Medicaid. And we do this as best as we can. And so we would typically expect some revenue from prior periods as disclosed in the Q in the range of somewhere between 3 to 5 percentage points, and that's in line with Q2 of this year. Last year, there was a higher percentage and hence, we called it out.

Understood. And sorry, just on CMS, is CMS back part of this? Or is that separate?

Yes. It's not really a key revenue driver of the prior period claims in this quarter.

Our next question coming from the line Jonathan Chang with Leerink Partners.

First question, how should we be thinking about your path to profitability? How are you tracking relative to your plans? And what are the key levers? And is there a timeframe that we should be modeling around. And then second question on the pancreatic cancer opportunity. Are there plans to pursue combinations with other chemo regimens beyond what's being evaluated in PANOVA-3 and 4?

Yes, Jonathan, it's Christoph. So on our path to profitability, I would first say, look, it's very important for us to get to profitability. And as we alluded to in the past, we have a path to profitability. We are obviously very conscious of balancing investments in our launches as well as in future innovation. So basically R&D with our intent to become profitable. In the past, we gave some color around that at a revenue level of around $750 million, we would expect to break into profitability from an adjusted EBITDA perspective. And I think that's still a good anchor to think about. And I think we don't really want to give you a clear timeframe. But I think with the revenue growth that you have seen in the past that will probably give you some indications of when we think that's going to happen. I would say to your question of where are we relative to our expectations? We are in line with our expectations. To the second question, and thank you for that one. Allow me first to contextualize that PANOVA-3 was the first positive trial with OS. And on top of that, the quality of life was positive as well as we saw it at ESMO. On top of it, the pain-free survival was very positive. And that led to a huge discussion and interest by the investigators. And interestingly, when you combine TTFields to GNP, standard of care, you don't have added adverse events, which means it's highly combinable, if I may say. So we are actively discussing actively looking into new combinations, and there are a few to come with a number of groups out there.

And Jonathan, I'll just remind you that the next data set we'll have public with pancreatic cancer is our PANOVA-4 data, which comes out in the front half of next year, company-sponsored looking at atezolizumab, gem/Abraxane, nab-paclitaxel in metastatic pancreatic cancer, so we'll have that in hand, and I think that will also inform future directions.

Our next question coming from the line of Jessica Fye with JPMorgan.

Two questions for me sort of following up on some of the prior ones. First, can you just take us through why the METIS PMA in the back half of '25 could conceivably come after the PANOVA PMA in the third quarter of '25, given how much longer we've had the METIS data relative to PANOVA? And the second one is just to clarify the comment on revenue from prior period claims. I think you said it was 3% to 5% of revenue. Do we apply that to the $94 million of U.S. Optune Gio sales this quarter, so like 2.8% to 4.7%. Or should I apply that 3% to 5% range to some other revenue number?

Jessica, this is Ashley. I'll address both of your questions, and if there's a need for further clarification, I'll pass it to Christoph. The first question has a straightforward answer related to the submission format. For METIS, we have a modular submission, with modules 1 and 2 submitted to the FDA in April this year. This is significant as it marks the first review of this device by the FDA, specifically for our Torso application at 150 kilohertz, which is the frequency used for lung cancer detection. Modules 1 and 2 need to receive FDA approval before we can submit module 3, which is the main reason for the timeline. We are having positive discussions and have a pre-submission meeting scheduled with the FDA later this quarter for the clinical module; however, the timing will depend on the review process for modules 1 and 2. Once those are approved, we will focus on the clinical module. Next, I'd like to point out that this situation is not new. You can look back over the previous years, and we’ve consistently seen it in the 3% to 5% range. Whenever it exceeds that range, we make sure to highlight it in our statements.

Our next question coming from the line of Kevin DeGeeter with Ladenburg Thalman.

I want to follow up on Optune Lua specifically the positioning as more of a post-platinum progression versus second line. Specifically for the NCCN guidelines, is there anything you're looking for potentially in the language there to help you support your positioning in the market discussions with payers? And I guess on a related point, have you had any feedback from payers as to whether they see the distinction as material when they consider potential coverage decisions?

I'll start with the note on payers. I believe we've made some initial progress with them, which I attribute to the fact that there is a significant clinical unmet need that both doctors and payers recognize. Regarding our positioning and its relation to NCCN guidelines, we don't see a strong connection there. We need to align with the guidelines that NCCN has already established and are not trying to influence how they present their guidelines. However, what we are actively doing is publishing real-world evidence related to the patient population we have treated commercially. We aim to use this information to shape physicians' perceptions about where to use the device and eventually extend its use deeper into the community. The idea is that once a patient is post-platinum and is not responding well, they should consider using Optune.

Great. As a follow-up, in your previous calls, you mentioned the potential opportunity for U.S. commercial decisions on Optune Lua possibly in 2025, depending on the timing of the NCCN guideline release. Is this still the correct way to view the pace of discussions with major U.S. payers, or should we expect a more realistic assessment as we enter 2026?

Yes, Kevin, it's not a simple switch. These things build up over time, and we are already seeing early successes. We generated $1.1 million this quarter, and we expect to add a significant amount each quarter to reach our target, aiming to finish 2025 with a modest but meaningful contribution from Optune Lua in the U.S. We believe we're on track for this, with the main driver of top-line growth expected to materialize in 2026. So, we anticipate exiting 2025 strong, leading to substantial top-line growth in 2026.

Our final question comes from the line of Emily Bodnar with H.C. Wainwright.

Could you clarify if the $94 million in U.S. sales includes the $2.4 million from Optune Lua? Or was that separate? And then in terms of revenues from Germany, would you expect any kind of one-off reimbursement cases similar to what you're now seeing in the U.S. in the second half of fiscal '25?

So Emily, the $94 million encompasses all revenue, including Optune Lua, which consists of both Optune Gio and Optune Lua. We have the opportunity to pursue case-by-case reimbursement in the U.S. and Germany. Thus, we expect a similar trajectory in Germany to what we are experiencing in the U.S.

This is Frank. Thank you for the question. I would say we're not able to track overall survival, so we can't comment on a hard clinical endpoint. However, we do see that the usage of the device is consistent with what we observed in the trial, which is our best indication that these patients are using it in a similar manner. Moreover, as I mentioned, we have physicians who have had patients on from the launch quarter. We're quite far along, and they are showing strong confidence in building their practice with more patients on the therapy.

And there are no further questions in queue. I will now turn the call back over to Mr. Bill Doyle for any closing remarks.

So thank you. As we've underlined during the last few quarterly calls, this is a very exciting time at Novocure. We are moving from a single indication company, treating patients with GBM, to a multi-indication international cancer therapy company. We've made tremendous progress this year so far, all first on the foundation of a very strong and stable business in GBM. And one where, as Ashley and Christophe noted, we now have hit the 11th successive quarter of active patient growth. And from there, we're in the early days, but exciting days of our Optune Lua launch in non-small cell lung cancer, and we are furiously busy at the FDA with both our METIS and our PANOVA-3 filings with the potential for launches next year in pancreatic cancer and in brain mets from non-small cell lung cancer. We're busy. It's exciting and we look forward to keeping you up-to-date in future calls.

Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation, and you may now disconnect.