Novocure Ltd. Aktie

Good day, and thank you for standing by. Welcome to the NovoCure's Q1 2026 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker today, Adam Daney. Please go ahead.

Good morning, and thank you for joining us to review NovoCure's First Quarter 2026 financial performance. I'm joined on the phone today with our Executive Chairman, Bill Doyle; CEO, Frank Leonard; Chief Innovation and Medical Officer, Uri Weinberg; 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, novacure.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 thus reflects the financial value generated by our business. We do not provide forward-looking guidance for adjusted EBITDA on a GAAP basis due to the inability to predict share-based compensation expenses contained in the reconciled GAAP measure net income without reasonable efforts.

Reconciliations of non-GAAP to GAAP financial measures are included in the press release, earnings slides and our Form 10-Q filed with the SEC today. These materials can all be accessed from the Investor Relations page on our website. Following our prepared remarks, we will open the line for your questions.

I will now turn the call over to our Executive Chairman, Bill Doyle.

Thank you, Adam. This morning, we reported results for the first quarter of 2026, and I am pleased to say we've had a strong start to the year. Both active patients and net revenues grew with double-digit rates year-over-year. Our launch in pancreatic cancer is off to a promising start and we are making progress on our journey to profitability.

With a number of additional catalysts expected this year, we look forward to building on this strong first quarter. On today's call, we will begin with a review of our pancreatic cancer program. Frank will then provide an update on our GBM and lung cancer programs. Christoph will conclude with a review of our first quarter financial performance before we open the line for questions.

The leading news in the quarter was the FDA approval and subsequent U.S. launch of Optune Pax for patients with locally advanced pancreatic cancer. Physician feedback has been positive since the PANOVA 3 data were presented and published at ASCO last year. There is broad recognition of the importance of the outcomes observed, including extensions and overall survival and time to pain progression. We believe Optune Pax can play a significant role in the treatment of pancreatic cancer, and we are pleased to be bringing Optune Pax to pancreatic cancer patients.

The early days of our Optune Pax's commercial launch have been encouraging. We received FDA approval on February 11. In the 7 weeks between the approval and quarter end, we certified 868 health care providers, 27 of whom are prescribers and academic centers, an exciting development as historically we've seen slower adoption of TTFields therapy in academic centers. Through March 31, we've received 169 prescriptions and completed 90 patient starts. We ended the quarter with 83 patients on therapy and a backlog of starts in the funnel.

We are also pleased to report our first major payer coverage policy for Optune Pax with Elevance Health, covering over 30 million lives. We will take a few quarters to fully understand the Optune Pax's adoption curve and reimbursement dynamics. But again, the early signals are very encouraging.

During the quarter, we also announced top line data from the Phase II PANOVA-4 trial, evaluating TTFields therapy together with atezolizumab and gem/Abraxane in metastatic pancreatic cancer. PANOVA-4 met its primary endpoint with a disease control rate of 74% compared to 48% in the historical control. Median duration of therapy was 25.6 weeks, a strong indication that TTFields therapy is feasible for use in the metastatic population.

As the pancreatic cancer treatment landscape evolves, we will evolve with it. After years of limited clinical success in pancreatic cancer, the medical community has seen positive outcomes in the PANOVA-3 and PANOVA-4 trials and positive data from a trial testing the pan-RAS inhibitor Draxton Rasib in second-line metastatic pancreatic cancer. RAS inhibitors are likely to be an important backbone therapy in pancreatic cancer in the future, and we are working to understand the benefits of their concomitant use with Tumor Treating Fields.

Earlier this month, at the American Association of Cancer Research, or AACR Annual Congress, 2 posters were presented, which evaluated in vitro and in vivo use of TTFields with daraxonerasid in pancreatic cancer models. The data presented show that KRAS inhibition, which blocks upstream oncogenic signaling and the down regulation of the CMIC protein caused by TTFields produce greater antitumor activity when used together compared to either therapy used alone. These data are promising, warrant clinical investigation and will be important inputs as we consider the next steps in our pancreatic cancer program.

Finally, a quick update on our product development initiatives. Over the last year, we've launched a number of product enhancements aimed at making TTFields therapy easier for patients and prescribers. This includes an HCP portal, which simplifies the prescription process lighter, more flexible, more comfortable HSV arrays for Optune Gio, a mobile app to help patients and caregivers navigate their TT fields experience. We are starting to see the fruits of these enhancements in our 90-day persistent rate, which covered below 70% as recently as 2024. In 2025, we have seen quarterly persistent rates tick up to 73%.

Our next major product improvement will be a new array for the torso. We are now finalizing the design, which will be compatible with Optune Pax and Optune Lua. The new arrays are designed to make major improvements in comfort and usability. We also expect these arrays to be more cost-effective to manufacture. We have completed usability testing in healthy volunteers and are evaluating performance in non-small cell lung cancer patients. Our next game is to have the new arrays available for use in future pancreatic and lung cancer clinical trials by year-end.

I'll now pass the call over to Frank for an update on our GBM and lung cancer programs.

Thank you, Bill. Our Optune Gio business remains the core driver of our commercial portfolio. We are off to a strong start to the year with 9% year-over-year growth in active patients globally. We saw our strongest growth in Japan, Germany and France, which contributed 20%, 12% and 9% year-over-year active patient growth, respectively.

Our Global Markets segment also had an outstanding quarter with 17% active patient growth, driven by a promising launch in Spain. We believe we can maintain low to mid-single-digit active patient growth in our mature markets and even higher growth in new markets like Spain and Czechia.

The next major catalyst in our GBM program will be top line data from the Phase III TRIDENT trial expected in the second quarter. The TRIDENT results will provide us with a better understanding of how TTFields can work with radiation therapy. TRIDENT moves the start of Optune Gio earlier in the GBM treatment journey, beginning with chemoradiation rather than following chemoradiation.

In TRIDENT, the patient population eligible for inclusion is broader than our EF-14 trial. In the EF-14 trial, patients who progressed in the short time between chemoradiation and screening were not eligible for randomization. In the TRIDENT trial, where randomization occurs prior to the start of chemo radiation, we are able to assess the use of TTFields in this previously ineligible cohort. We expect TRIDENT to give further insight into whether earlier use of TTFields therapy can drive additional survival benefit to a broader population of eligible patients.

Turning now to Optune Lua. In March, we received national reimbursement in Japan and began treating commercial patients. Japan provides a promising market for Optune Lua as our LUNAR clinical trial data more closely reflect the standard of care in Japan. On March 15, we hosted a symposium with approximately 250 Japanese lung cancer physicians in attendance, including a number of leading key opinion leaders. We are in the early stages of our launch, but we're encouraged by the physician interest and engagement thus far.

On the clinical trial front, as I have said from the beginning of my tenure as CEO, we need to update our strategy for the LUNAR-2 trial. We are exploring options now to modify the trial with the goals of compressing the time line to completion and significantly reducing the cost. We look forward to engaging with regulators to discuss the potential changes and providing a full update later this year.

Overall, this was a very strong quarter, and we are pleased with our progress. Our commercial focus is on expanding adoption in GBM, maintaining the momentum of our Optune Pax launch and capturing value in the markets where Optune Lua potential is greatest. We've reached a number of exciting commercial and clinical milestones in the first quarter and look forward to sharing more information on additional catalysts throughout the year. Christoph will now walk through our financial results from Q1.

Thank you, Frank, and thank you all for joining us this morning. We had a strong start to the year, continuing our momentum from 2025. Net revenue in the first quarter was $174 million, an increase of 12% year-over-year. The increase was driven primarily by continued growth in our markets outside the U.S. including increases of $6 million and $5 million from Germany and France, respectively. Germany benefited from increased approval rates, which provided a onetime benefit of $2.5 million and France benefited from contract performance improvement, which provided a onetime benefit of $1 million.

We also had a $5.6 million tailwind from changes in foreign exchange rates compared to Q1 2025. Net revenue from Optune Lua in the first quarter was $3 million compared to $1.5 million in Q1 2025. Based on the strength of our first quarter results in GBM, we are updating our full year revenue guidance to a range of $690 million to $710 million, representing 5% to 8% growth. We are maintaining the range for combined revenue from Optune Lua and Optune Pax at $15 million to $25 million for the year.

Gross margin in the quarter was 78% compared to 75% in Q1 of 2025. This was primarily driven by lower costs for arrays resulting from improved array utilization and lower supplier prices. We continue to expect annual gross margin in the mid-70s for the full year 2026, as we bring more Optune Pax patients on therapy prior to establishing broad reimbursement.

Research and development costs in the quarter were $58 million, an increase of 8% compared to the same period in 2025. This was primarily driven by increased costs associated with the KEYNOTE-D58 trial. As a reminder, this is a 700-plus patient trial, which we expect to fully involve by the end of this year.

Sales and marketing expenses in Q1 were $58 million, up 5% from Q1 2025. This was driven by launch costs for Optune Pax in the U.S. and Optune Lua in Japan. G&A costs in the quarter were $86 million, up 92% from the same period last year. As we mentioned last quarter, we incurred a $43 million share-based compensation charge triggered by the approval of Optune Pax. I do want to note this expense is included for GAAP accounting purposes and the grant associated with this charge did not vest and shares were not distributed.

Our net loss for the quarter was $71 million compared to $34 million in Q1 2025. Excluding the onetime share-based compensation expense, net loss was $28 million. Loss per share in the quarter was negative $0.62.

Adjusted EBITDA in the quarter was negative $0.3 million compared to negative $5 million in the first quarter of 2025. We are updating our full year adjusted EBITDA guidance this morning to a range from negative $15 million to breakeven. This reflects our strong start to the year as well as accelerated expenses from our Optune Pax launch.

Our cash and investment balance as of March 31, 2026, was $432 million.

Thank you all for joining us this morning. We will now open the line for Q&A.

[Operator Instructions] And our first question will come from Jonathan Chang of Leerink Partners.

Can you provide any more color on the early Optune Pax's launch like, the number of prescribers, the types of centers where you're seeing utilization, the early clinician patient feedback? And help us contextualize how does this compare to the early lung cancer launch experience?

Thanks, Jonathan. I appreciate the question. We are seeing -- we're really proud of the Optune Pax's launch, both our preparation and also the response from the market. As Bill mentioned in his opening remarks, we had over 800 certified prescribers in just the opening months essentially of approval. And as Bill mentioned, 27% of the certified prescribers are from academic centers. So -- and while we haven't given specific statistics on the number of prescribers who actually wrote in the first quarter, I will say that we were pleased it was a breadth across both community and academic centers as well as prescribers who even in the first 5 weeks wrote multiple prescriptions.

So I think as we get into the second quarter, we will be able to give a little bit more color on that, quantitative color on the prescribing trends and who's prescribing and where. But in terms of just the aggregate demand experienced in the first month of launch, we're very pleased.

And to your question about how this compares to our lung launch, we would say this is across whatever metric we want to look at, it is multiples of demand and really just a significantly different reception from the prescribing community.

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

Congrats on a really nice quarter here, and let's start with Optune Pax. So I'll start there. The launch here is significantly better than what we were thinking. It's really nice to see. Wondering if you could expand a bit more on those results, where you're at with physician on forwarding versus the prescribing process? And I guess what I mean there is your early metrics are so strong and have been wondering about the steps that's converting certified prescribers and 2 active prescribers, are those prescribers predominantly those that were part of your trial and that's why they were able to move so quickly with prescriptions? Just any color you can add here as we think about the launch curve after physicians are certified and then moving into that prescribing of Pax.

Jason, thank you. I appreciate the question. I -- what I would say is the -- to your question sort of around who are those initial prescribers, I would actually start by just referencing back to the fact that this is the first significant approval for this indication. It's really -- if we look just to the stage of locally advanced pancreatic cancer, this is the first successful trial in that space. And so while we've seen very strong engagement from the PIs who participated in the trial, the interest is much broader. And it was essentially a buildup of demand that we were able to meet at centers we've never worked with before, academic centers where we've previously had very difficult times gaining access, wanted to have us in there in the first week so that they could immediately add to the standard of care.

So I think we'll really go into some more numbers as we move forward into the next quarters. But it's -- again, I would say this is very broad-based. There's not one single cohort that was able to go first. And more on that process to remind everyone, as a device, we do have to train and certify our physicians as a first step. Once that training and certification takes place, they're able to prescribe right away. Those who have worked with us before might be a little bit more sophisticated about how to transfer prescriptions to us.

But what I'm also really pleased to say is we've made significant investments over the last year into our HCP portal, the ways in which we work with physicians to transfer the prescription and the related data that's required, such that I think we've lowered the bar in terms of the burden on the physician. And as a result, we've seen that speed to prescribe.

Yes. And the only thing I'd add is, the enthusiasm really started to build at ASCO last year when the data were first presented. We saw just a great reception from the podium. And so to your specific question, the interest has certainly had an opportunity to build and was far broader than the investigators.

Okay. Excellent. Maybe 1 quick follow-up and then a separate 1 on guidance. But a quick follow-up. Just as we think about that launch curve, you've been in market here for now 3 months or almost 3 months, what does that look like in February to March to April, if you can share any real-time feedback on that launch trajectory?

And then separately on the guidance question, for revenue, you bumped the midpoint by $10 million. You beat consensus by $6 million. So a pretty strong statement out of the gate here. Maybe talk about, if you could, what you're seeing real time over the balance of the year that let be comfortable raising the revenue guide by more than the beat?

Jason, I'll comment on the trajectory and then pass to Christopher-- to Christoph. We can't comment on the trajectory in the current quarter only on the prior quarter. I would just say that when you look at the -- there's FDA approval, then there's a bit of time where we have to refile our labeling with the FDA. And you look at the last quarter really in the context of essentially 4 weeks in market. I'd go back to what I said before that we were very pleased by the results. We see real strength in that initial interaction with our customers, and we are very excited for the rest of the year in terms of continuing the momentum. Yes.

And Jason, Christoph here. So to your guidance question, I would say we came off the back of a very strong 2025 and also Q4. And we have seen in Q1 that we were able to carry that momentum into 2026, which gave us the confidence combined with the strong revenue also in Q1 to increase the guidance to what we have seen $690 million to $710 million.

And our next question will be coming from Kevin DeGeeter of Ladenburg Thalmann.

Congratulations on the great quarter. [indiscernible] specifically, can you comment on kind of what you're seeing in terms of your funnel for contracting and coverage with some of the commercial payers and provide any updated thoughts on engagement and potential for CMS coverage for uses for occupant?

Sorry, Kevin, I think we were getting a little bit of a breakup as you were speaking. But I believe the question was directed towards our pathway to coverage and reimbursement for Optune Pax in the United States. I'll start by highlighting we're very pleased to have our first major payer in the United States covering Optune Pax with the coverage policies from -- and we will continue to work through the reimbursement process with the other major payers, private payers in the U.S.

What we've typically said is that we expect around a year to 2 years to work through a coverage process in the U.S. for private payers and more on that full 2-year window to have a revision to the LCD for the Medicare coverage.

In terms of contracting, we had existing contracts in place with most payers in the United States. So we actually do not have a contracting step on Pax. So once a coverage policy is issued the reimbursement is in place on the private side.

Lastly, I'll just close by noting we do have a -- we do view NCCN guideline inclusion as an important step, and we are continuing to -- we have filed with the NCCN to request that guideline inclusion, and we are monitoring the situation closely.

And our next question will be coming from the line of Vijay Kumar of Evercore ISI.

Congrats on the nice print here. I guess, Bill or Frank, my first one was on this pancreatic noted RAS inhibitors. I'm curious on -- just to be clear, right, I think Revolution Medicine had some good data. Just to be very clear, their approval is not a headwind to your -- to Pax, correct? Because correct me if I'm wrong, the indications for your trial are very different versus Revolution Medicine. Could you just clarify that, please?

Thank you. Vijay, thank you very much. Thank you for the question. We are -- when we think about Optune Pax and TTFields for pancreatic cancer, I always want to highlight back to the fact that pancreatic tumors have a low bioavailability for drugs, which is a big reason for why so many drugs have failed in this indication in clinical trials. It's also a reason why we see that excitement from the treating community because using a physical modality against the tumor is intuitive when the tumor has low bioavailability. And so we see this strength of interest in Optune Pax that you see in the commercial launch numbers. But we also do see that in clinical interest in the number of IST proposals we receive and the interest in helping us to design our next wave of trials in pancreatic cancer.

And so we think our device has a unique biophysical rationale for being used in this tumor type that is definitely recognized by the treating community.

In addition, as you know, we are approved for locally advanced pancreatic cancer, which is a unique indication from where the current RAS inhibitor Phase III data is. And we think we feel very confident that we have a path forward to continue the excitement that we've seen in the first quarter. And I'll ask my colleague, Dr. Uri Weinberg, to comment also on the exciting work that we've been doing to study TTFields with RAS inhibitors.

Thank you. Vijay, nice to hear you. So first, we certainly continue to monitor developments in all of our areas of interest, and we are encouraged to see the new advancements in the field of KRAS inhibition, first and foremost, for the patients, but also with a direct relation to TTFields. TTFields were found to inhibit CIMIC, which is a master regulator of cancer cell proliferation. And therefore, TTFields mediation of downregulation of CIMIC may actually complement the upstream KRAS inhibition and that would support a potentially more effective therapeutic strategy when the 2 treatments are used together.

And in particular, CIMIC can also be activated through bypass pathways. And as Bill mentioned in his opening remarks, this data has been recently presented at AACR and in a very complementary fashion an independent group of researchers from Mayo Clinic looked into the concomitant use of TTFields and KRAS inhibitors and also repeated these same preclinical effects and reported even a synergy when the 2 therapies were used concomitantly. So we are very encouraged by that.

Yes. And if we take a step back, we've always maintained that with Tumor Treating Fields, there's an opportunity to use with whatever the prevailing pharmacological therapy may be. We've never seen anything less than additivity. And in certain circumstances, we see the synergy. And now we've seen synergy with checkpoint inhibitors, and we're pursuing that strategy with our KEYNOTE-D58 trial in newly diagnosed GBM. And we can see a future here where synergy with RAS inhibitors is also a very interesting treatment strategy for these very difficult to cure cancers.

That's helpful. And then maybe one big picture question. Look, when I look at the stock, clearly, you're not getting any benefit or credit for some of the positive data you've had, whether it's lung or pancreatic. I'm curious, maybe The Street wants to see revenue acceleration rate. When I look at your assumptions here for GBM in pancreatic, could NovoCure get back double-digit growth in fiscal '27? Generally talk about big picture, how we should be thinking about the revenue profile for this company going forward?

Thank you, Vijay. I'll comment first on big picture themes around the GBM business and the Pax launch, and I'll turn it to Christophe to talk a little bit more about how we think about the long-term financial forecast. So first, we are very pleased to see growth last year in our GBM business, not just international growth and opening new markets, but also in the core original business in the U.S. growing. And as we've said before, we believe there are many more patients that can benefit from the therapy. As we currently have a penetration rate in our active markets of around 40%.

And so what we've continued to do is invest into our GBM business, both the capabilities on the sales and marketing side to essentially dual-cover doctors. So if we have a call in a community practice for pancreatic cancer, that same rep is now able to reach the community doctors to detail on GBM. We've also improved our sales operations and targeting capabilities. And we really do feel like we've -- in our core businesses and particularly in the U.S., we have the right team and the right skill sets in place right now to continue driving growth.

And so we think that foundation alone is really an exciting way to think about the next few years. And what we've seen in panc right now gives us really an incredible amount of confidence that we can turn this into the second major revenue pillar for the company in the coming years.

Yes. And maybe just to add to this. So to reiterate our strategies very clearly to get to double-digit revenue growth and also to profitable growth and to profitability. Now we gave you a revenue guide for this year that is ranging from 5% to 8% at the midpoint, 7% growth, with what I would classify as very initial contributions from new indication launches. So with more material contributions from new indication launches, we expect to get into the double-digit revenue growth in the future.

And our next question will be coming from the line of Lawrence Biegelsen of Wells Fargo.

I wanted to ask, of course, about pancreatic launch. When we look at newly diagnosed GBM, I mean, we only have one quarter here, but it looks remarkably similar on prescriptions better on active patients. I know it's early, but what can you say when comparing prescription launch in the U.S. and active patient ramp for newly diagnosed GBM to pancreatic? Let me just -- I'll just ask all my questions upfront. Was there any pent-up demand for Q1 for Pan and then just OUS timing, remind us of that, please.

Larry, this is Frank. Thank you for the question. I would say we are -- we haven't really focused on comparing panc to our prior GBM launch for a technical aspect, which is simply that, in GBM, we have been approved in second-line therapy and had existing relationships and then in first-line therapy. The data had been out for over a year before the FDA approval. So it's sort of, on a technical basis, it becomes difficult to take an exact comparison point.

So what I would anchor back to is the almost 900 prescribers who sought certification in the first month of commercial availability, that was -- as we said before, that was multiples of the certification levels that we saw in our LUNAR launch. We did -- we do think that reflects some pent-up demand, but I don't -- I wouldn't -- I would absolutely not describe it as a bolus of patients waiting and that it then normalize to a different level. We do just see really strong interest from the community in using Optune Pax to treat their locally advanced pancreatic cancer patients.

And OUS?

OUS, yes. I'm sorry. Thank you. In terms of OUS, Christoph, can you remind me of the timing?

Yes. So we said second half for both German -- TUV approval as well as for Japan approval.

Yes. And all the applications are in we're now just sort of waiting for those submissions. And if everything proceeds as expected, we would launch in the second half in those regions.

I mean just maybe 1 follow-up up, Frank. I mean do you think pancreatic could ultimately be bigger than GBM overall? I think you've said that in the past.

Well, I certainly -- so I think the pancreatic -- I think in our current indication in locally advanced pancreatic cancer, we believe there's around 16,000 patients, which is already bigger than the eligible patient population for Optune Gio. As we build our evidence base out and when we're able to secure those additional FDA approvals, it just keeps growing from there. So we are absolutely committed to success in this indication and we think it has trended -- as I said before, to have a tremendous potential to be our second major revenue driver. And ultimately, the population is bigger than the population for our current business.

And our next question will be coming from the line of Emily Bodnar of H.C. Wainright.

Congrats on the strong first quarter. Curious if you could comment a bit on your confidence for converting the full 169 prescriptions to access patients and if you can kind of comment on what the average timing has been to converting patients from prescription to active therapy?

Yes, appreciate the question because it was a big difference between prescriptions and active patients, and that simply reflected the timing of having 1 month at the very end of the quarter. So we don't intend to give the number of starts every quarter, but what I will highlight is that we had 90 starts, which led to that active patient number. And we saw typically about 2 weeks -- a little bit less than 2 weeks from a prescription to a start. And so those -- that $163 million reflects a lot of prescriptions right at the very, very end of the quarter that we'll be talking about on the next earnings call.

And maybe on metastatic cancer. Obviously, you have the Pinova 4 data and then you also touched on kind of potential synergy with RAS inhibitors. Maybe just kind of talk about general strategy moving forward for the metastatic setting.

So thank you for the question. Yes, we were very pleased to read out the results of the PANOVA 4 study. As a reminder, our single-arm study in metastatic pancreatic cancer patients using a combination of gemcitabine atezolizumab Ross PD-L1 inhibitor and TT fields. The primary endpoint was met. The primary endpoint was disease control rate, and it was significantly increased as a result of using the therapeutic regimen in Pan from the historical 48% into 74 I think that the most important message and takeaways from the PANOVA 4 study is seeing again, the relevance of PTCL therapy as a therapeutic approach to be developed in the metastatic setting in pancreatic adenocarcinoma, and following our demonstration of the clinical effectiveness in locally advanced pancreatic cancer in the PANOVA 3 study and the approval that paves the way to continue the studies and development in this space.

And the population use TTFields therapy at a very desirable usage rates. They use it for the entire protocol indicated duration of treatment. RECONNECT So again, a great evidence of PDF's role in metaancreatic cancer, and we continue to explore directions may come back to this regimen at a later point in time.

And our next question will be coming from the line of Jessica Fye of JPMorgan.

This is Tammy on for Jess. I wanted to ask for option tax, you mentioned the backlog of staff from the funnel. So I was wondering if the conversion from prescriptions to patients on therapies going on as expect -- and what do you expect the ultimate to be from those getting prescriptions to those patients who tensilinitiate on therapy?

Thank you for the question. We -- again, we wanted to be clear that with 1 month essentially 1 month and a few days of activity where we could take prescriptions and convert to starts. It's hard to give definitive answers around trends about the rate at which prescriptions will convert to starts. But the consistent theme I want to emphasize is that we are very pleased with the results so far. We -- in particular, I'm really proud of our team who helps the patients, our technical support team that's helping our patients. This is a new patient population for them.

And I think the main takeaway in that first month is that we could execute quickly to move from prescription to start -- and as I mentioned, we had a good strong correlation between active patients at the end and the starts that occurred in the quarter, which means we're giving them the right support to make the treatment feasible and practical.

And I'm showing no further questions at this time. I would like to turn the conference back to Bill Doyle for closing remarks.

I'd like to end the call today by noting that NovoCure was able to maintain the momentum of the fourth quarter last year with strong and consistent execution in Q1. We're very pleased to see growth in both double-digit growth in both active patients and net revenue compared to Q1 last year and very promising early signals, both from our LUNAR launch in Japan and, of course, from our Optimum pack launch in the U.S. Our 2026 catalysts remain on track. We look forward to continued reporting on the developments in the commercial business as well as the top line data from Trident up next in next quarter.

We didn't talk about it much in this call, but our company remains focused not only on achieving the double-digit growth that Christoph underlined, but also on bringing the company to profitability. And we were also very pleased with our numbers in that regard. And we are focused as we have updated in our guidance on our path to profitability. So thanks to the team at Novocure, thanks to our patients and clinicians. And it's an exciting time to be at the company, and we look forward to reporting our progress in the next quarters.

And this concludes today's program. Thank you for participating. You may now disconnect.

Good day, and thank you for standing by. Welcome to the NovoCure Fourth Quarter 2025 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I'd now like to hand the conference over to Adam Daney, Head of Investor Relations. Please go ahead.

Good morning, and thank you for joining us to review NovoCure's Fourth Quarter and Full Year 2025 performance. I'm joined on the phone today with our Executive Chairman, Bill Doyle; CEO, Frank Leonard; 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 today 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.

We do not provide forward-looking guidance for adjusted EBITDA on a GAAP basis due to the inability to predict share-based compensation expenses contained in the reconciled GAAP measure of net income without reasonable efforts. Reconciliations of non-GAAP to GAAP financial measures are included in our press release, earnings slides, and in our Form 10-K filed with the SEC today. These materials can also be accessed from the Investor Relations page of our website. Following our prepared remarks this morning, we will open the line for your questions.

I will now turn the call over to our Executive Chairman, Bill Doyle.

Thank you, Adam. I'll begin this morning with a brief review of our 2025 accomplishments and look ahead to 2026. Our CEO, Frank Leonard, will then discuss recent commercial updates. And finally, our CFO, Christoph Brackmann, will walk through our fourth quarter financial performance and 2026 guidance before opening the line for questions.

2025 was a year of progress and change at NovoCure. We generated a record $655 million in net revenues last year, an 8% increase from 2024. We presented final data from 2 large randomized trials in plenary sessions at major medical congresses, followed by publications in leading medical journals. We submitted PMA applications to the FDA for the use of TTFields therapy to treat pancreatic cancer and brain metastases from non-small cell lung cancer. And we rolled out product enhancements designed to improve the TTFields therapy experience for both patients and physicians.

2025 was a strong year of execution, setting the stage for a catalyst-rich 2026. We expect to reach a number of regulatory, clinical, and commercial milestones this year. The first milestone was reached earlier this month with the approval of Optune Pax for the treatment of locally advanced pancreatic cancer, and we have submitted regulatory filings for Optune Pax in Europe and Japan. We expect Optune Pax to be a significant contributor to our long-term growth and are eager to begin treating patients in the coming weeks. We also expect a decision from the FDA on our brain metastases PMA later this year.

On the clinical front, we are on track for top-line readouts from both the PANOVA-4 and TRIDENT trials this year. PANOVA-4 is a Phase II trial exploring the use of TTFields, atezolizumab, a checkpoint inhibitor, and chemotherapy in metastatic pancreatic cancer with top-line data anticipated next month. TRIDENT is a Phase III trial exploring earlier use of TTFields concomitant with radiation and temozolomide in newly diagnosed GBM, which we expect to read out in Q2. We are also on track to complete enrollment of our next Phase III trial, KEYNOTE D58, studying Tumor Treating Fields, temozolomide, and the checkpoint inhibitor pembrolizumab in newly diagnosed GBM by year-end.

Turning to our commercial portfolio. We anticipate a number of national or regional launches of our 3 products this year. This includes Optune Gio launches in Spain, Czechia, and the Canadian province of British Columbia, and Optune Lua launch in Japan and Optune Pax launches in the U.S. and Germany.

Before I hand the call over to Frank, I would like to touch on one update from this morning's press release. Dr. Nicolas Leupin, our Chief Medical Officer, resigned from the company effective February 25. Following Nicolas' departure, we have decided to combine our scientific and clinical organizations to accelerate our R&D execution and shorten the cycle from scientific insight to clinical relevance. Dr. Uri Weinberg, our Chief Innovation Officer, will now also assume the role of Chief Medical Officer. Dr. Weinberg joined NovoCure in 2008 and has been instrumental in establishing and leading a number of our scientific and research and development functions over the years. Uri is well qualified to take over this dual mandate. I would like to personally thank Nicolas for his contributions to NovoCure and to congratulate Uri on his expanded role.

With that, let me hand the call to Frank to walk through recent updates.

Thank you, Bill, and good morning. I'm excited to speak to you in my new role as CEO and at a time when NovoCure is evolving into a multi-indication platform company. 2025 was our most successful commercial year to date, and we expect to carry this positive momentum into 2026. Our business remains core, our GBM business remains core to our commercial operations. In 2025, we saw substantial active patient growth across all our major markets. OUS markets were the biggest driver, including 10% year-over-year growth in Germany, 19% in France, and 29% in Japan. We also saw 4% active patient growth in the U.S., which had been flat in recent years.

In 2026, we expect growth rates to stabilize in the low to mid-single-digit range as these markets continue to mature. We should also see a tailwind from new market launches in Spain, Czechia, and British Columbia, though first-year revenue contributions are likely to be modest.

Turning to Optune Lua. We are preparing to launch in Japan. Japan represents a promising opportunity for Optune Lua, given first and second-line use of immune checkpoint inhibitors is standard of care in Japan. We expect to receive our final reimbursement approval in the coming weeks. We will then be able to launch in Japan with national coverage and pricing. As we've previously stated, the Optune Lua launch has been slower than we originally projected in the U.S. and Germany. We have rightsized our marketing spend based on the current demand and are prioritizing investments in indications with a higher return potential, such as pancreatic cancer.

Finally, I will turn now to our newest FDA approval, Optune Pax for locally advanced pancreatic cancer. We are very pleased to have received FDA approval and appreciate the agency's partnership throughout the review process. The industry standard time for PMA reviews is between 9 to 12 months. In the case of Optune Pax, the FDA review was completed exactly at the 180-day mark, with approval received on February 11. We've commenced our Optune Pax launch and are now certifying prescribers and receiving prescriptions. We have designed the launch plans for Optune Pax to make prescribing and starting patients as easy as possible for physicians, including emphasizing the use of our HCP portal to enable digital prescriptions.

We are also giving the prescriber more discretion in patient selection rather than detailing to a preferred patient profile. We are also able to leverage our established torso sales force for the Optune Pax launch. The existence of a trained team significantly lessens the educational burden of onboarding a new team and enables us to take advantage of the established team's deep knowledge of TTFields therapy. This team has built extensive connections with physicians, which will prove invaluable given that some medical oncologists treat both lung and pancreatic cancer patients.

There are a lot of similarities between GBM and pancreatic cancer that give us confidence in both the market opportunity and our ability to commercialize Optune Pax. Both cancers are typically diagnosed at a late stage and are incredibly difficult to treat. Both cancers have properties that limit the bioavailability of systemic therapies, making these tumors prime targets for a physical treatment approach. And both tumors have limited approved therapeutic options for patients. We are eager to begin treating patients in the coming weeks.

Now is an exciting time to step into the CEO role at NovoCure. Since I joined the company in 2010, we have had numerous clinical, regulatory, and commercial milestones across multiple indications, and we are now primed to enter our next era of substantial growth. I'm thankful for the opportunity to lead at such an exciting time, and I want to thank all of my colleagues for their dedication and support during the transition.

I'll now pass the call over to Christoph to review our Q4 and full-year 2025 financials as well as our guidance for 2026.

Thank you, Frank. We closed 2025 with continued momentum, delivering record net revenue for both the quarter and full year. Fourth quarter net revenue was $174 million, and full year net revenue totaled $655 million, representing 8% year-over-year growth for both periods. Growth was primarily driven by continued expansion in ex-U.S. markets, particularly Germany, France, and Japan, reflecting solid underlying demand and increased active patient count. Foreign exchange provided a tailwind of approximately $5 million in Q4 and $11 million for the full year compared to 2024.

We recognized $3.5 million from Optune Lua claims in the quarter, including $2.4 million from non-small cell lung cancer. For the full year, Optune Lua revenue was $10.4 million, including $5.8 million from non-small cell lung cancer patients. I would also like to briefly address the recent Medicare billing situation. Earlier this month, CMS notified us that our billing privileges were halted due to an administrative issue identified during the DME supplier revalidation process. We engaged with the agency quickly, submitted a corrective action plan the following business day, and completed our required reinspection. Two days ago, we were notified that CMS rescinded the revocation and directed that our Medicare enrollment and billing privileges be reinstated retroactively to December 17, 2025. As a result, we do not expect any negative impact on revenue recognition from this matter. We are pleased that the issue is resolved and are appreciative of the agency's partnership in addressing the issue swiftly.

Looking ahead to 2026. This morning, we issued annual net revenue guidance at constant exchange rates of $675 million to $705 million, representing year-over-year growth between 3% and 8%. This assumes Optune Gio net revenue growth in the low to mid-single digits and net revenue contributions from non-GBM products of $15 million to $25 million compared to $10 million in 2025.

Moving down the P&L. Fourth quarter gross margin was 76% and 75% for the full year compared to 79% and 77% for the fourth quarter and full year 2024. The decrease was primarily driven by a decrease in prior period collections in the U.S. and increased costs associated with the HIV rates and tariffs. For 2026, we expect gross margin in the mid-70s percentage range. Research and development costs in the quarter were $61 million, an increase of 19% from the same period last year, and $225 million for the full year, an increase of 7%. The quarterly increase was driven by increased costs related to the KEYNOTE-58 and LUNAR-2 Phase III trials and regulatory costs.

Sales and marketing expenses in the quarter were $69 million, an increase of 2% from Q4 2024, and full year sales and marketing expenses were $240 million, flat year-over-year. The increase in the quarter was driven by increased marketing activities related to new indications. G&A expenses for the fourth quarter were $43 million, a decrease of 41%, and $178 million for the full year, a decrease of 6% from 2024. The primary driver for the quarter was lower share-based compensation expenses related to 2020 PSUs triggered by the approval of Optune Lua in 2024. As noted in the 10-K today, we will have a similar charge in Q1 triggered by the Optune Pax approval.

Net loss for the quarter was $24 million with a loss per share of $0.22. Full-year net loss was $136 million or $1.22 per share. Adjusted EBITDA in the quarter was negative $16 million and negative $34 million for the full year. Our cash and investment balance at the end of Q4 was $448 million. In the fourth quarter, we repaid $561 million of convertible notes in cash. We believe our current funds available, coupled with diligent expense management, will provide the necessary bridge as we bring new revenue streams online. Therefore, we have decided not to go beyond the $200 million already drawn from our current credit facility.

As we look ahead to 2026, we are determined to make material progress towards our goal of driving profitable growth in the coming years. This morning, we issued adjusted EBITDA guidance of negative $20 million to breakeven for full year 2026. Overall, this reflects an acceleration of our plans to achieve adjusted EBITDA breakeven, driven by both our expectations of revenue growth as well as diligent expense management across the organization.

With that, I'll turn the call back to the operator for Q&A.

[Operator Instructions] Our first question comes from Jason Bednar with Piper Sandler.

Congratulations on the recent approval of Optune Pax. There's probably too many topics to choose from this morning. There's a lot going on here. But why don't I start first with the guidance? This is obviously a first for NovoCure, glad to see it. So can you talk about why it made sense now to give the guidance versus past years? And then can you break out some of the contributions included within the revenue guide around maybe things like you're assuming with new international markets? I think you called out Spain, Czechia, and Canada. And then as well as whether you're assuming anything in the revenue and EBITDA guide from previously denied claims.

Thanks, Jason. This is Frank. I'll start with top line, and then I'll hand it to Christoph to go into some of the assumptions. First, I just want to also say thanks for the recognition of the many positive headlines we had in the last quarter and closing out 2025. It certainly has been an exciting time here at NovoCure. Jason, as I came into the role as CEO, one of the things we did is really try to spend as much time with our investor community as possible. One of the core messages that we've heard is that we need to speak more clearly in terms of setting expectations of what we can accomplish in the coming year. And we're taking that first step today with guidance where we really want to send the signal first at the top line that we are committed to returning the company to steady growth.

And this is the first year where the Optune Pax will build a foundation that we can make even stronger going out to 2027. Two is that we're sending a very clear signal that we want to drive to adjusted EBITDA breakeven as a possibility this year because we've heard the message loudly and clearly that we need to have both growth and profitability. And lastly, I think I just would emphasize that as a company, we're trying to send a signal that we're moving up the maturity curve. We've been a public company for 10 years. We think this is a necessary and important step to take right now. So Christoph?

Yes. Thank you. So yes, on the specifics on guidance or the underlying assumptions, on the revenue side, there's really 3 areas that we are thinking of in terms of growth. There's our GBM business in established markets where we expect growth in the low to mid-single-digit growth -- mid-single-digit range. Then we have GBM in newer markets. So an example of this would be Spain or Czech or also the recent approval in Canada that we announced. Now these will be modest contributions in 2026 as we ramp in 2026 in those markets. And then the third bucket of growth would be new indications. And yes, that's also where -- as you can see, we say we are expecting contributions in the range of $15 million to $25 million. So growth over prior year connected to the launches that we have with Optune Lua in Japan and Optune Pax in the U.S., as well in other markets.

Our next question comes from Vijay Kumar with Evercore ISI.

This is Kevin on for Vijay. Just one on Optune Gio. It looks like the guidance assumes a low to mid-single-digit revenue growth. My understanding is that this market, over the long term, is more of a mid-single-digit growth type of market. Is this just conservatism embedded in the guidance? Or are you seeing a change in the market growth rate?

Thank you for the question, Kevin. No, we are not seeing -- we're not signaling a conservatism or a moderation. We're trying to signal that we believe the -- number one, we believe there are still many patients who will benefit from Optune Gio with glioblastoma. As a reminder, we think in our mature markets, we're on average, about 40% of the patients are getting a prescription for Optune Gio. And we think based on the data that we've already generated, that number should be significantly higher. And so the range is really intended to reiterate our ability that we've shown last year to grow in that mid-single digits range, but at the same time, to provide that guidance of a band that reflects all of the assumptions that could come into revenue, including -- just including the various puts and takes on when revenue comes online.

Our next question comes from Larry Biegelsen with Wells Fargo.

Congrats on the Pax approval as well coming in earlier than expected. So on that product, can you just talk about, based on the approved label, how do you think the device will be prescribed? And specifically, what are the lessons learned from the lung launch that you can apply here to ensure success? And I have a follow-up regarding the guidance.

Yes. Thanks, Larry. This is Frank. I'll start, and I might turn it to Christoph at the end to just comment on the market size itself. So first, we're very pleased with the approval for Optune Pax, both the label that we received as well as the timing. And I think that the quality of the data that we brought to the FDA should really be underlined in that sense that we were able to secure this 180-day review cycle. Optune Pax is being approved for locally advanced pancreatic cancer in a first-line setting in concurrent use with nab-paclitaxel plus gemcitabine. And so I want to emphasize that's a first-line patient with locally advanced disease, so still focal disease. We think this is a highly motivated patient population. It's a population also that has had really very limited treatment options to date. And we think this fits very nicely with our overall value proposition to physicians and to patients, that we can bring this unique physical approach to layer on top of the existing systemic therapies that, quite frankly, have not been successful enough in pancreatic cancer.

So to answer the question directly, we believe within that label, that really is the core population that we can pursue first, and we're very happy that that is because we believe it's a highly motivated patient and a highly motivated physician.

And Christophe, could you comment a bit on the market assumptions?

Yes, sure. So we estimate the TAM for locally advanced pancreatic cancer in the U.S. to be 15,000 patients on an annual basis. This is down from about 60,000 patients being diagnosed with PDAC on an annual basis, and then about 1/3 is in the locally advanced pancreatic setting.

Our next question comes from Jonathan Chang with Leerink Partners.

This is Albert Aginis on for Jonathan Chang. Congrats on the approval of Optune Pax. Regarding that topic, how much sales force are you allocating for Optune Pax? Do you foresee or have you recruited new commercial team members to accommodate for this launch? Or is it more of a reallocation of the current commercial team?

Thanks, Albert, for the question. We are very pleased that we have an established team that we've trained over the last 2 years to detail our Optune Lua product. That team that's already in the field and fully established is being -- repurpose is probably the wrong word, but I should say, tasked now with leading our pancreatic launch. So we're not adding incremental sales headcount at this time. We are simply leveraging the team that we have.

Our next question comes from Emily Bodnar with H.C. Wainwright.

Congrats on the Optune Pax approval. So you guided to the $15 million to $25 million in revenue for Optune Lua and Optune Pax this year. I'm curious if you could kind of give some more detail into how we should be thinking about revenue contribution, specifically for Optune Pax this year, as you're kind of getting reimbursement plans in place? And then maybe a follow-up to the prior question. How much of your sales and marketing force that you already have is kind of in place for HCPs that are going to be covering locally advanced pancreatic patients based on your GBM and non-small cell lung cancer launches?

Excellent. Thanks, Emily. I'll start, and I'll turn it over to Christoph. Just as a reminder for everyone, as we launch in a new indication, we do, as a medical device, need to go through a process of working with the payers to establish coverage policies and in some cases, having updates to our contracts with the payers in the United States to then move towards a position where we have a more direct correlation between active patients and revenue. At the start, we will start all of the patients, and we'll begin working through an appeals process, just as we've done with glioblastoma and lung before, and it's a process that we're quite familiar with, and we're confident we're going to be able to work through it.

But that will mean that in this launch period, you will see revenue not correlate directly with active patients because there will be a lag as we establish the coverage policies and the payment policies with payers in the United States. I'll flag that as always, for us, one of the most critical steps in that process is to secure an inclusion in the NCCN guidelines for the treatment of locally advanced pancreatic cancer. We have submitted that application, and we're hopeful to be included soon. And we think that will be one of the material steps this year towards securing the coverage policies that will drive some revenue this year, but ultimately, it will be revenue that will come next year. Christoph?

Yes. I think the only thing to add to what you said, Frank, maybe would be that similar to what we said for Optune Lua, we expect it will take us about 1 to 2 years to get coverage on a more routine basis for commercial payers. And that's also connected to the launch success, right? The more patients that we have on therapy, the easier we'll get to get coverage policies.

And Christoph, there was also a question about sales and marketing expenses.

Yes. So in terms of sales and marketing expense, as we -- I mean, as Frank alluded to earlier, we are basically reusing this field force. So when we built the field force for NACLC last year and earlier, basically, we thought of it as a Torso-focused field force. And so from a field force perspective, there is no incremental -- very small incremental spend, if any, incremental spend on the pancreatic launch will be on the marketing side. Part of that already we had in Q4 of last year.

That concludes today's question-and-answer session. I'd like to turn the call back to Bill Doyle for closing remarks.

So in closing, I'd like to underline that 2025 was a year of strong execution at NovoCure with record net revenue and record active patients. We're very pleased with our 2 Phase III presentations and publications and the 2 PMAs submitted, which we think really create the foundation for success in the future. We're set to maintain that momentum with a catalyst-rich 2026. We're pleased to have already received the PMA approval for PANOVA for Optune Pax, and to have submitted the regulatory filings in the EU and Japan. And we're looking forward to the top-line results from PANOVA-4 and TRIDENT.

On the commercial side, we expect to maintain our momentum as has been discussed on this call, and we're really excited to bring our products to patients in new markets, particularly Spain, Czechia, and in British Columbia. We've really tried to emphasize to everyone today that we're focused on driving to profitability. As Frank said, 10 years in the public markets, we're ready to guide, and we're ready to make that one of our primary goals. We see a path to profitability and, in fact, the potential to reach adjusted EBITDA breakeven this year. With that, I'd like to end by thanking you all for your continued interest and focus on NovoCure. And in particular, I need to thank my colleagues. 2025 was a year of accomplishment and change as we position the company for the exciting future that we see ahead of us.

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

Great. Good morning, everyone. My name is Jess Fye. I'm a biotech analyst at JPMorgan, and we're continuing our 44th Annual Healthcare Conference today with NovoCure. First, you're going to hear a presentation from the company, and then we're going to have a Q&A session. [Operator Instructions]. But with that out of the way, let me turn it over to the company's CEO, Frank Leonard.

Thank you, Jess. It's my privilege to be here today to present NovoCure's preliminary 2025 results as well as look ahead to a catalyst-rich year in 2026. For those of you who don't know me, I have taken over as CEO just a few months ago. However, I've been with the company now for 15-plus years. And prior to that as a venture capital investor and part of the team that helped to bring the first institutional investments into NovoCure.

And I -- through that time, I've covered multiple areas for the company, including our product development, corporate strategy, reimbursement groups and then more recently, leading us through a reorganization of our commercial organization to drive us back to growth. And I'm excited because as much as we are proud of our past accomplishments, 2026 is a year of multiple catalysts and we'll detail those as I move forward.

But first, let's set the stage on NovoCure, the company itself. What are we today? First, NovoCure has developed, pioneered and commercialized an effective wearable cancer therapy that is currently a standard of care for glioblastoma patients. We built ourselves from there to have successful clinical trials across multiple indications that we'll discuss today. This is a unique way of treating cancer. And in a moment, I'll go back to our core mechanism of action and how it is unique from other therapies pioneer to date.

We're proud that we've built a market-leading position, not only in the United States but across key markets around the world to help patients with glioblastoma, which as a reminder, is the most deadly form of brain cancer.

We are also excited as a company that as we look ahead to 2026 and beyond, we have the ability to continue expanding both within glioblastoma, growing our existing markets as well as entering new markets, and from there, launching in additional indications in pancreatic cancer and brain metastases from non-small cell lung cancer.

We'd also like to be sure that we're communicating these growth opportunities in light of a clear commitment to a path to profitability starting first with our commitment to reaching adjusted EBITDA breakeven.

So let's go to Tumor Treating Fields, our core therapy and what it is. Tumor Treating Fields are alternating electric fields that target the electrical properties of cancer cells. For those of you coming to the story from a biotech or a biology background, I'd encourage you to think about cancer cells in the accumulation of calcium ion. Cancer cells are unique through many different ways, their electrical properties transform, the introduction of a substantial influx of calcium ion inherently changes the capacitance of a cancer cell, making it unique relative to healthy cells.

For those of you coming to the story from a med tech background, I'd ask you to think about the therapy in terms of how electric fields are typically applied in medicine. We've historically built devices at low frequencies and direct current that are stimulatory and have the ability to do things like TENS units and pain relief or bone growth stimulators.

On the other side, with high-frequency devices, we can induce heating and ultimately ablation. We are applying intermediate electric fields that until our founders' research were thought to be inert. Our unique insight is knowing that those fields have a selective and unique effect on cancer cells due to the differentiated electric properties of those cells.

So what have we done with this therapy over the 25 years of our company's existence? We have demonstrated success now across a wide range of solid tumors, where patients are desperately in need of additional options. Our business started first with success in glioblastoma where we were able to show a 5-month improvement in median overall survival for patients with glioblastoma. Most importantly, as you look at the Kaplan-Meier curve, our device, for the first time, moved to the 5-year survival for glioblastoma patients above 13% for the intent-to-treat population.

But I'll highlight that we have additional evidence showing that for patients who use our device at the maximum available usage per day and consistently, they were actually able to outpace that result and show strong durable long-term survival.

From there, we moved on to our successful LUNAR study in non-small cell lung cancer. Our LUNAR trial was in the second-line setting for Stage IV metastatic non-small cell lung cancer. Patients were able to use Tumor Treating Fields with a backbone systemic therapy or a systemic therapy alone and the systemic therapy included a physician's choice of either docetaxel or an immune checkpoint inhibitor.

In the intent-to-treat population in this trial, we demonstrated a significantly significant improvement in overall survival. And specific to the patients who were treated with immune checkpoint inhibitors plus Tumor Treating Fields, we show that the concurrent use of those 2 therapies produced a profound effect on clinical outcomes, specifically survival. And as I'll talk about in a moment, we believe this outcome from this trial shows that when you exert physical stress on a cancer cell, you achieve not only our primary direct cytotoxic effect, which is an antimitotic effect by inhibiting the mitotic spindle formation but also a cascade of downstream stress signaling from the physical effect of Tumor Treating Fields on multiple proteins within the cell and through that stress signaling and upregulation of the immune response to tumors.

More recently, in 2025, we announced annual results from 2 additional significant pivotal studies. First, we announced and published our data from the PANOVA-3 study in locally advanced pancreatic cancer as a first-line setting. We demonstrated again a statistically significant improvement in median overall survival with a 2-month OS benefit in pancreatic cancer.

We're also very excited that this trial showed a 6-month extension in progression -- sorry, in pain-free survival for patients with pancreatic cancer. And we note that pain-free survival is one of the most meaningful clinical endpoints for patients treating this disease.

I'd also highlight that if you look between glioblastoma and pancreatic cancer. These 2 tumors have something unique in common. Both have a low bioavailability for drugs. They are difficult tumors to treat with systemic therapies. In glioblastoma, over the last 25 years, despite hundreds of trials, there has been 1 systemic therapy approved. In pancreatic cancer to date with an even greater number of clinical trials over the last 25 years, there have been 5 drugs approved. These are 2 tumors that I'll highlight through the presentation that are in specific need of a biophysical approach to augment the incredible systemic therapies that are being developed today.

And lastly, I'll note that in the September time frame, we also announced and published the final results from our METIS study for patients with non-small cell lung cancer that had metastasized to the brain. In this study, patients were given SRS, stereotactic radiosurgery, to treat their brain tumors and either left for watchful waiting or added or given Tumor Treating Fields as an additive therapy. In this trial, we showed a doubling of the time to intracranial progression when Tumor Treating Fields was layered on top of the SRS treatment.

Now looking back to 2025 to summarize our results. First, I want to highlight that we are exiting 2025 in a strong financial position due to the growth that we were able to drive in our core GBM business. We saw growth in all of our active markets in glioblastoma, and I'll drill down on that in just a moment. That growth led to us posting $655 million of revenue in our preliminary results that we announced this week, which represents an 8% revenue growth year-over-year.

As I highlighted on the previous slide, our success in pancreatic cancer and in brain mets is enabling us to move forward with new clinical indications, and we have completed filings for both our PANOVA-3 data with FDA and our METIS data with FDA.

Lastly, as a medical device that's worn by patients 24 hours a day often, we have a unique relationship, not just with the physician who is prescribing to treat the patient, but also with the patient who is using our device to extend their survival. As such, we aim to strengthen our relationship with that patient through the introduction of better technology to improve their ability to physically use our device as well as through digital technologies that enable them to interact with us more in real time, to understand their treatment, to ask for troubleshooting and to gain clarity over what needs to come next in their treatment with the device specifically. That, we believe, will enable the physician -- the patients to use the device more consistently through the day. And based on our past results, we believe that increased usage can drive a longer duration of therapy.

So let's drill down and look at our GBM business last year in 2025. Across the globe, we drove a 9% increase in active patient volume. That growth comes from all of our key markets, and I'll highlight that in Japan, we grew our active patients by 29%, by 19% in France and 10% in Germany as well as showing growth in all of our smaller markets around the world.

I'm also particularly excited to note that our U.S. GBM business has grown by 4% year-over-year based on a strong Q4 close. We are currently active in 8 markets around the world, and we believe, this is -- that our results in 2025 represent the strong work of our teams over the last 3 years to reevaluate, reprioritize and then execute upon opportunities that were there for us to take and by extension for patients to gain access to this important therapy.

So looking ahead commercially, we do intend to continue growing in both of our approved indications. In glioblastoma, around the world today, after our 2025 results, we believe in our key markets, our penetration rate is somewhere in the range of 35% to 40% of eligible patients depending on the country. We know that based on our strong pivotal trial results, we can drive that adoption higher. This is a disease where without our device, the 5-year survival rate drops below 5% and with it, it moves above 10%. We want to continue emphasizing the benefit of the therapy as well as introducing new data sets to further confirm the benefit of Tumor Treating Fields, and we'll elaborate on those in a moment.

We also plan to capitalize on selective opportunities to increase our geographic footprint, and I'll note that in 2025, we announced we have achieved national reimbursement in Spain for Tumor Treating Fields for the treatment of glioblastoma. Additionally, we're going to selectively look for new countries where the opportunities may be smaller, but they are substantial and take those opportunities where we think they make sense financially.

Now turning to our existing business in non-small cell lung cancer, which is treating patients in the second line of Stage IV non-small cell lung cancer. We have launched in the U.S. and Germany, and we have acknowledged that our launch is behind plan and has been challenged. We currently have 122 patients on therapy in these 2 markets. What we are stating today is that we recognize this challenge, and we have accordingly addressed the sales and marketing spend within our existing lung business in the existing markets appropriately to recognize the challenges that we're facing.

Looking ahead, though, we do see markets where the treatment paradigm today for the second-line patient in Stage IV non-small cell lung cancer does justify continued investment. And we have consistently highlighted that in Japan, patients are more often continued on an immune checkpoint inhibitor from the first line to the second line. And we note that our discussions with KOLs in Japan have been favorable in terms of the benefit of adding Tumor Treating Fields into the second-line setting for patients in Japan.

So while we have seen challenges in this market, and we are making the necessary financial decisions to recognize those challenges, we will continue to invest selectively where we see the potential to build a sustainable business.

Looking ahead, as I've already highlighted, we have 2 exciting launches on the horizon. Again, our launch in pancreatic cancer will be in locally advanced patients in a first-line setting. We believe the total addressable market includes around 15,000 patients in the United States, and we are anticipating a launch in Q2 following a regulatory approval in the same quarter.

To put this in perspective, this market is slightly larger at 15,000 patients than the addressable market that we have in our GBM patient today -- GBM patients today. And as I've noted, we believe that in pancreatic cancer, where there have been so many failures after so many attempts and billions of dollars spent to address this tumor with a systemic therapy the physicians understand the unique benefit that biophysical approaches will bring to patients in need.

Moving towards the end of the year, we anticipate a Q4 regulatory approval and launch for our indication, treating patients with brain metastases from non-small cell lung cancer on the basis of our METIS study.

This market, again, at 16,000 potential on-label patients in the United States is slightly larger than our existing market for glioblastoma. And so taken together, we believe these 2 markets put us on a path for a multiyear growth trajectory that will enable us to build a bigger and sustainably profitable business, treating patients in these 3 indications.

Now I've spoken before, but I want to tie together some of the themes that we hope to address in the coming years as we think about both our commercial business and our R&D portfolio. Tumor Treating Fields in the petri dish in animal models has shown a broad ability to kill cancer cells across multiple cancer cell lines and in tumor models in multiple different animal models. We really haven't seen a reason for Tumor Treating Fields not to work scientifically when you apply it against the cancer cell.

What we have seen is that this is a device that must be worn 24 hours a day and used by a physician who more often than not is comfortable using drugs over devices. And we need to, as a company, lean into and understand that our device has a specific set of unique benefits that on the flip side, while maybe, I would say, advantages that allow us, in some respects, to target tumors that we cannot otherwise access. We do also, at the same time, have to recognize that wearing a device will also be something that we have to introduce into the paradigm. And accordingly, we want to invest very judiciously where we think the device can be recognized by both the physician and the patient as the most unique opportunity to address the clinical need.

So specifically, as I've mentioned before, 2 areas that we want to highlight today are tumors with low bioavailability for systemic therapies and tumors where our ability to regulate -- to upregulate the immune response through enhanced stress signaling of the cell will produce a better effect for immune checkpoint inhibitors against that target.

With that, I'd like to turn to review our existing R&D portfolio in light of these 2 unique aspects of Tumor Treating Fields. First, we are excited that we will -- we have completed and will announce top line results for our PANOVA-4 study in Q1 of 2026. PANOVA-4 is in the metastatic pancreatic setting, first-line setting for metastatic pancreatic cancer, where the patients will receive Tumor Treating Fields plus atezolizumab plus gemcitabine, nab-paclitaxel doublet, which is building on our PANOVA-3 study where the patients received gemcitabine nab-paclitaxel doublet.

We believe this is an important trial first in that it gives us evidence in the metastatic setting beyond the locally advanced setting studied in our P3 study. And additionally, this allows us to gain insights into whether or not Tumor Treating Fields can provide a stronger benefit for atezolizumab in this setting.

We will also announce in Q2 2026 results from the TRIDENT study. TRIDENT is a Phase III study in newly diagnosed glioblastoma, adding Tumor Treating Fields as a therapy on both arms of the study. I think, I want to emphasize this point again, Tumor Treating Fields in TRIDENT is a backbone therapy and is not -- this study is one moment where the physician community around the world who treated glioblastoma, recognized Tumor Treating Fields is a standard of care and the trial is designed not to answer the question of does Tumor Treating Fields work, but how does it work best.

On the active arm of this study, we have moved Tumor Treating Fields earlier in the treatment paradigm than our existing approval such that Tumor Treating Fields will be used concurrent with radiation and chemotherapy. And in the control arm, patients will then wait to begin Tumor Treating Fields until the completion of their radiation and chemotherapy regimen.

So this is a question for the trial -- the trial is asking the question of how best to use Tumor Treating Fields within the glioblastoma setting, recognizing that Tumor Treating Fields should be backbone therapy for all patients.

Moving ahead, we are also conducting 2 large Phase III studies. First, we have our KEYNOTE D58 study, continuing our research in newly diagnosed glioblastoma. And leaning into our 2 unique benefits.

In this study, again, Tumor Treating Fields is viewed as a backbone therapy and is being used as the standard of care in both arms. In this study, pembrolizumab is being added as the active therapy on the interventional arm, giving us the chance again to study the effect of Tumor Treating Fields on taking a tumor such as glioblastoma, where pembrolizumab has failed as well as other immune checkpoint inhibitors have failed in multiple studies and asking whether we can produce a better response for patients. We are announcing here that we're pulling forward the expected LPI date for this trial to Q4 of 2026.

And lastly, within our R&D portfolio, I'll highlight that we are conducting our LUNAR-2 study in Phase -- our LUNAR-2 trial, a Phase III trial for the first-line treatment of metastatic non-small cell lung cancer. This trial builds on our prior result in the second line and brings the therapy forward to a first line again using concurrent pembrolizumab therapy in the first line.

We are looking at the study, as I've highlighted and brought forward, as we move forward at NovoCure, we will take a look at all R&D investments, including this R&D investment to understand how does it best fit within our understanding of the unique benefits of Tumor Treating Fields relative to what the other systemic therapies can bring to bear for the tumor.

So taking all of this together, let's look at the list of catalysts for 2026. First, in Q1, we have the release of top line data from the PANOVA-4 Phase II study in metastatic pancreatic cancer. Coming in Q2, we then released top line data from the Phase III TRIDENT trial in glioblastoma, and in Q2, we also anticipate the launch of Optune Pax for the treatment of locally advanced pancreatic cancer in the United States.

In Q4, we have 2 important milestones, one being the complete enrollment in LPI for Phase III of KEYNOTE D58, starting the follow-up clock for that trial. And additionally, our commercial launch following an anticipated regulatory approval for Optune Mya for the treatment of brain metastases from non-small cell lung cancer in the U.S.

We are also excited through the year to continue building on our existing business in glioblastoma, expanding our penetration in our existing key markets while also selectively finding those new markets where we can build a sustainable business that is both helping patients and contributing to our bottom line.

As we look at this together, our strategic road map is quite simple. We intend to drive adoption in our existing businesses in a financially responsible way, which will enable us to invest in and scale our portfolio through strong launches in both pancreatic cancer and in brain metastases. By extension, we've made the choices necessary to ensure that further investments into the commercial activities in our lung business will be appropriate given the demand curves that we've anticipated through our launch years.

We're also committing to ensuring that our investors hear us articulate a clear path to profitability as we move forward. Given that we have so many exciting growth opportunities ahead, it would be easy to simply state we're investing everywhere all the time to drive growth. That's simply not feasible as a device company trying to pioneer a new therapy. And so we are announcing here today that at our February earnings call, where we announced our full year result, we will provide guidance on both top line revenue and bottom line guidance on adjusted EBITDA, which we view as the first important milestone in our return to profitability. We want our investors to understand both our vision for growth as well as how we intend to accomplish that through financially prudent investments.

To take that one step further and just to share, as my role -- in my new role as CEO, how I think about the prioritization, we have to start first and foremost with the fact that our business helping GBM patients is what makes everything else possible. And we have to continue investing there, both on the commercial side as well as in our clinical portfolio, where we're going to bring important new evidence to bear through the TRIDENT and D58 studies. From there, we have to get our launches right in pancreatic cancer as well as in brain metastases.

Putting those 2 priorities against this commitment to the path to profitability and our drive towards adjusted EBITDA breakeven. We will review our R&D portfolio to ensure that our R&D allocations fit first and foremost with our top priorities, and we'll make additional announcements and details available as we move forward in the coming quarters on those decisions that we will take.

Taking all of this and taking just one step back, I'll close by highlighting that Tumor Treating Fields is now in its 25th year of development. The technology was -- the insight was developed by our founder, Professor Yoram Palti. And unfortunately, Professor Palti passed away this week. He passed away knowing that tens of thousands of patients have benefited from his technology, having met several of them. And I think that's what's always been unique for those of us who have joined NovoCure is the fact that all of us are here today at JPMorgan because we want to advance the future of medicine. And for those of you in the room who are focused on oncology, we really want to advance survival.

Specific to NovoCure, what I'm proud of is that because our therapy brings these differentiated effects that are not based on a systemic medical effect, we've been able to go after those tumors where we've seen failure after failure after failure. And while I will acknowledge as a device in the oncology world, we do sometimes swim upstream of physicians who want to use drugs first. We think that we have these unique attributes of a therapy that can't be replicated that give us; number one, a clear path to commercialization in our key markets, and number two, as you've seen in our GBM business, strong durable businesses that grow continuously.

GBM, we've been in market in the United States for 10 years, and we're still posting growth. We've defended our profit margin and our pricing in the United States over 10 years. And so I think as you think about NovoCure, while there are challenges of being the device in the oncology world, it also produces the durable moats around the business that we intend to lead into in the coming years and do that as we try to continue the mission that we started on that Professor Palti set us on 25 years ago.

So with that, Jess, I'll turn it over to you for questions, and I'll invite my colleagues Bill Doyle, our Executive Chairman; and Christoph Brackmann, our CFO, to come and join me.

Great. Thanks for that [Operator Instructions] but I'll start. So Frank, as you've taken the helm as CEO, can you talk about what your goals are for NovoCure and kind of what's likely to change and what's going to remain the same under your leadership?

Thank you. Yes, it's I think I'll start with what's going to remain the same. I think that we are a company that thrives on tackling these aggressive tumors and taking shots where we think we can really move the needle in cancer. So we you don't see us trying to pick up the easy indications. I think we will continue to operate where we think there's very high unmet need.

But to reiterate, as I stepped in, I think the challenge we've had in the past is that because our therapy has worked in every cell line, in every animal model, it's really easy to convince yourself that you can tackle every tumor type.

And my mantra to the team today and over the last 2 months is really lean into the fact that we have differentiated benefits that we bring. And that should carry through both to the marketing materials of really explaining the therapy through this biophysical lens through the failure of past drug trials to address tumor types. And then as we undertake our efforts to review our existing R&D portfolio to think through what does that mean going forward about how we invest the next R&D dollar.

So you highlighted the growth in GBM. And at the moment, it's sort of the core revenue driver, what gives you confidence in kind of sustaining this growth in '26?

I would say, I think it's -- I always think of it as 2 things coming together. I think on the one side, right now, through hard work over the last 2 years, we've done the operational effort to bring us to this moment. And what do I mean by that? We have reinvested in our sales and marketing teams in GBM to ensure that they're in the best position to find the physician and the patient at the moment that the treatment decision is being made, not just on the pure operational side.

We've also put ourselves in a really successful position to have the TRIDENT study, which is largely run by radiation oncologists, has just closed out this last year still has patients either on or now off, but in follow-up. And that trial over 2 years gave us direct engagement on the clinical side to all of the rad oncs with CNS experience. We then couple that trial, as it was closing, opened the D58 study setting pembrolizumab for GBM patients, which then put us into the academic sites.

And so if you look at 2025, we were engaging in academic sites that we haven't previously worked with. We were restrengthening our relationships with rad oncs who have previously driven our business. And we were doing that all on the back of really operational excellence in how we approach the position. And those trends we expect to continue. So that's kind of one side of the story.

The second side of the story of why I see our ability to drive growth is that, quite frankly, with every year that goes by, the evidence accumulates that Tumor Treating Fields is producing a stable, durable long-term effect for GBM. I would highlight that the Mayo Clinic across all of its health systems last year published a systemic review of patients over the prior -- I think it was prior decade, showing the Tumor Treating Fields had a statistically significant improvement in OS within their health system and including noting that it was producing durable, sustainable, long-term survival. So then we layer on top of that, we have TRIDENT reading out D58 coming up. I think we put ourselves in a place to build additional evidence over the coming years to keep this growth going.

Question in the audience?

Thank you very much for -- great presentation. Two questions, if I may. One, regarding pipeline beyond GBM and pancreatic tumor. I remember there were mesothelioma in the pipeline before. How are you thinking about what are the priorities besides challenges of the disease and bioavailability of the drug, how you're prioritizing? And the second question, our understanding is the main limitation of adoption has been some side effects regarding skin issues and battery packs, et cetera, any R&D effort in that to solve those problems, too?

Yes. I'll address the first part about R&D, but Bill, I'll actually ask you to talk about the product development side of this. So on the R&D to just continue on, when we think about -- so we do have an approval for mesothelioma in the United States. It's a limited approval under the humanitarian device exemption. We had the CE mark and have launched in Germany for mesothelioma. It's a relatively small indication to begin with and for us, it's a relatively small patient population. So we generally group it as we think strategically with our overall non-small cell lung cancer portfolio, recognizing they are actually different diseases.

What I would say is that we've seen over the last year, we know physicians who are interested in using Tumor Treating Fields for those diseases. We'll continue to support them. We're continuing to look incrementally for growth. We're not intending to open up any new investments either in MPM or as we move forward, we have our big investment in LUNAR-2 for non-small cell lung cancer. We're not at any time in the next couple of months, anticipating bringing forward a new concept in those areas because as I mentioned, in terms of prioritization, to be clear, funding is growth in GBM successfully launching the 2 new indications. And then within the R&D portfolio, figure out how we bridge to a path the profitability.

And thank you for your question about the product. we have the benefit that the therapy that Frank described so well comes with no systemic toxicity, so that's a plus. On the minus side, there is a patient burden and that's true. And the patient burden is associated, as you described, with one, as we attach these patches to the skin. Some patients have a skin sensitivity and exhibit contact dermatitis. And I said to everyone in the audience, if I put a band aid on your forehead for 2 years, chances are a number of you would get skin redness.

The other aspect of the patient burden is that they do have to carry this box. And today, the box weighs about a kilo, which doesn't sound like much, but if it's with you every day all the time, it's something that has to be dealt with and the patient has to overcome that. The good news for us is that we have a lot of opportunities to work on both of those patient burdens.

The first change that we'll make is an introduction of a next array that changes the skin contact material. And all of our testing to date shows that it's much less irritating on the skin. And I think we have an opportunity in the midterm here to really address that issue. We're also very focused on the box now, too, and we benefit from improvements in battery technology.

Quite frankly, we also need to look at product design historically, our box has been designed by electrical engineers, and it kind of looks like it was designed by electrical engineers rather than designed by CPG experts and our next generation will be smaller, will have a different form factor. And where we're also moving is to a combination device that is much more like a garment. So rather than patches that are either stuck to the head or the abdomen or the torso, it's going to be more like a garment that you take off and put on allowing patients to shower whenever they want and make it much easier. So we see a path to short-term real improvements in the arrays, medium-term improvements in the way the box is configured. And at the same time, moving toward a garment like device that just changes the use paradigm completely.

You touched on the TRIDENT study and that data coming up and how Optune is in both arms. So if that trial is successful, kind of encouraging the earlier use of Optune, how should we think about the incremental commercial opportunity that could be associated with that?

That's a fantastic question. I'll contextualize the data, and I'll ask Christoph, as our CFO, to talk a little bit about the downstream revenue opportunities. So the TRIDENT study to reiterate, is looking at moving Tumor Treating Fields earlier in the treatment of glioblastoma. So these would be patients who are newly diagnosed. And in the trial, they're randomized shortly after their diagnosis and then or shortly after finishing surgery before beginning radiation or chemotherapy.

This is a different population than studied in the EF-14 trial, which is our prior clinical study. And it specifically includes the group of GBM patients who typically progress quickly through radiation therapy, which has historically been about 25% of the patient population.

I bring that up to help contextualize the data because it's a different -- I want to emphasize again, it's a different patient population than EF-14 and cross-trial comparisons should not be made in that setting because 1 trial TRIDENT includes patients expected to progress quickly, whereas EF-14 were patients who started at a stable position and use Tumor Treating Fields.

So I say all that to say that, first and foremost, the TRIDENT study introduces Tumor Treating Fields to that additional 25% of patients, we simply don't see today. So if physicians begin Tumor Treating Fields during radiation therapy, they have, on average, 25% more patient population to select from. Now for that population, we do think duration may be slightly muted because obviously, they will progress. However, for those patients for the other 75% of patients who will benefit -- who will be stable, we do expect that we'll produce better duration of therapy overall than in our prior study. So it's a bit of a mix of puts and takes but when you look at all of them, they're all on the positive side.

Yes. And maybe to quantify a little bit more. So as Frank said, we charge for our therapy on a monthly basis, right? So longer duration directly translates into higher revenue for us. So on the one hand, we would expect because patients would start with a treatment journey about 2 months earlier. That's about 20% additional duration just from starting earlier. Then the other question that we don't know is what will be the additional benefit on being maybe longer on therapy because of additional efficacy. And the other area of where there could be a benefit is by starting more patients earlier, albeit with maybe longer -- smaller duration for the total population.

And if maybe I can add one more point around TRIDENT. Today, the GBM patient journey starts with usually a seizure than an MRI, then they go to a surgeon, then they get this 2 months of chemoradiation from a radiation oncologist and then they get their maintenance chemo from a medical oncologist. As Frank's described, our best prescribers are radiation oncologists. They understand physical modalities. If the point of prescription is the point where they're directing therapy. That's also a potential advantage for us in addition to the advantages that Christoph described.

Yes, makes sense. And then heading into the PANOVA-4 data in metastatic pancreatic cancer, what would be the next steps there and assuming or encouraging data? And what are the benchmarks we should look at when we interpret that data set?

Yes. So we -- okay. So to start with the benchmarks. We've pointed investors to the study by Dr. Dan Von Hoff and his colleagues that established approximately a 50% disease control rate for that patient population. And disease control rate is our primary endpoint. So we think we're coming in while the trial is a single-arm Phase II study, it is one that will be well understood within the historical context of results.

And I think what comes next is that we'll have to -- we do have to see the data to look at pathways forward. The landscape for the treatment of metastatic pancreatic cancer is obviously evolving minute by minute. I haven't followed what happened in the last 10 minutes here. We're very aware of that. And we're aware of the evolution of the RAS inhibitors. We'll need to see the benefit from an immune therapy, and we have multiple pathways forward to design our next study in pancreatic cancer, noting that objective response rates with the RAS inhibitors are still at best hitting around 50%, which means there's a strong need to augment the therapy. And noting that we're talking about taking patient survival in the 6- to 8-month range and trying to move the needle. That's a long way to go to getting patients to having 5-year survival.

Yes. Maybe in the last 20 seconds, I'll add to that. We're really excited to see these data with checkpoint inhibitors. But we've always described Tumor Treating Fields as a modality that can be combined with whatever the best pharmacology is so we've already started work of Tumor Treating Fields plus RAS inhibitors as well. And at least preclinically, it's very promising.

Great. so we'll leave it there. Thank you.

Thank you.

Thank you.

Good day, and thank you for standing by. Welcome to the Novocure Third Quarter 2025 Earnings Call. [Operator Instructions] Please be advised, 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 third 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 the 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 in our Form 10-Q filed with the SEC today. These materials can also be accessed on 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 in some of the most aggressive forms of cancer. Through our early years, our efforts focused mostly on the treatment of patients with glioblastoma. Now with one launch ongoing and 2 additional launches planned for next year, the scope of our mission has expanded to reach more patients who can benefit from Tumor Treating Fields in multiple solid tumor cancers. As we evolve from a single indication company to a true platform therapy company, we are focused on 3 priorities: First, preparing to treat 4 cancer indications by year-end 2026. Second, reaching profitability. And third, making disciplined investments that strengthen our product portfolio in the near and the long-term.

We will begin this morning with a review of our Q3 commercial results in glioblastoma and non-small cell lung cancer. We will discuss regulatory updates and preparation for anticipated launches in pancreatic cancer and brain metastases. And we will provide updates to our ongoing clinical and product development programs. We will conclude with a review of our quarterly financials and open the line for questions.

Our GBM business remains solid and active patients have grown between 5% and 12% year-over-year for the last 9 consecutive quarters. We ended the third quarter with 4,277 GBM patients on therapy, our largest patient count to date. The largest contributors to active patient growth in this quarter were France, Japan, and Germany, which grew 27%, 8%, and 7%, respectively.

We also expanded our international footprint. Last month, we received a positive national coverage decision from the Spanish Ministry of Health. At maturity, we expect Spain to deliver annual net revenue that is approximately half that of France. We expect full ramp-up to take a few years given the fragmented nature of the Spanish health care system.

In the U.S., our GBM active patient count was flat compared to Q3 2024. While we are proud to be treating approximately 40% of GBM patients in the U.S., we recognize that many more patients could benefit from TTFields therapy. Unlike lung cancer and pancreatic cancer, where most patients seek treatment in community centers, virtually all GBM patients undergo brain surgery at high-volume academic centers after diagnosis.

Oncologists at academic centers often prioritize enrollment in pharmaceutical clinical trials over new medical device-based therapies. This dynamic limits the number of patients offered Optune Gio in academic centers despite the established clinical benefits of TTFields therapy. Our commercial team continues to refine its approach within this complex environment, and we remain committed to ensuring that all eligible GBM patients are offered Optune Gio therapy.

Turning to non-small cell lung cancer. We've acknowledged that our launch is behind expectations. And in Q3, we did not see a continuation of the linear growth we've seen in the prior 2 quarters. While we anticipated lung cancer would be our most challenging indication to launch, it has been harder than we expected. We finished Q3 with 100 lung cancer patients on therapy, 94 in the U.S. and 6 in Germany. What makes advanced lung cancer particularly challenging is the poor overall health status of these patients, the high level of competition from new targeted drug therapies, and the limited median duration of therapy, 4 months versus the 10 months for newly diagnosed GBM.

We experienced similar launch challenges in 2011 with our initial launch in recurrent GBM when we introduced our device-based therapy to the neuro-oncology community in an advanced cancer setting. With GBM, we learned that consistent education and follow-on data generation drives prescriber and patient adoption over time. We are anticipating a similar path in lung.

To delve deeper, lung cancer is a highly competitive space. The survival benefit demonstrated in the LUNAR Phase III trial remains among the best reported in the post-platinum setting. But the number of systemic drug therapies available across settings makes the transition to a novel device-based modality like Optune Lua seem like a heavier lift for both physicians and patients. Our sales team is tackling this by highlighting specific patient profiles to help physicians better understand where Optune Lua is likely to provide the best benefit. Our primary focus is on patients who have had a durable response to a checkpoint inhibitor plus a platinum doublet and have slow progression with a maintenance checkpoint inhibitor.

There is also the challenge of introducing a device-based therapy to a medical oncology community that has limited device experience. As mentioned, we faced a similar hurdle when we introduced Optune Gio to recurrent GBM. And we know it takes time and hands-on experience for physicians to gain comfort with a device-based therapy. Simply put, a wearable device is novel in the oncology space. And as such, we are connecting experienced Optune Gio and Lua users who can share expertise and tips based upon real-world use with physicians new to the therapy to simplify the integration of Optune Lua into their practices.

Looking to the near-term future, an important upcoming milestone for Optune Lua is our Japan launch. Last month, we received approval from Japanese regulators for the use of Optune Lua and checkpoint inhibitors in advanced or recurrent non-small cell lung cancer. Japan has been a consistently strong region for Novocure, and we are planning for strong physician adoption of Optune Lua. We believe a high prevalence of lung cancer, Japanese physicians' appreciation for device-based therapies, and a local standard of care, which frequently utilizes immune checkpoint inhibitors in the first and second lines, provides the conditions for a successful launch in Japan. We will be closely monitoring the dynamics of our Japan launch to inform future strategies.

Longer term, we are working on 2 core programs to reach more non-small cell lung cancer patients, LUNAR-2 and product development. LUNAR-2 is our Phase III trial studying the use of Optune Lua plus checkpoint inhibitors and platinum-based chemo as a first-line treatment for newly diagnosed non-small cell lung cancer. Assuming success, LUNAR-2 will allow us to treat first-line lung cancer patients with Optune Lua and a checkpoint inhibitor, the drug device combination demonstrating the best efficacy across indications. Our product development efforts are focused on making the Optune device easier for patients to use through near-term improvements in support services, software and array design and longer-term efforts to design a transformative next-generation device.

It is critical to underline, we believe our efforts in lung are worth it. The investments we are making for the lung cancer indication also paved the way for our anticipated launches in pancreatic cancer and brain metastases in the next 12 months.

In summary, our core GBM business continues to grow, reaching more patients in more regions. Our lung cancer launch has been more difficult than anticipated, and we are learning and adapting our tactics. We have 2 additional launches in cancer indications with extremely high unmet needs anticipated in 2026, where minimal therapeutic options are currently available and that we can access with limited incremental investment as our lung cancer and GBM infrastructures will be leveraged. We are confident in our strategic direction, the strength of the clinical data supporting the use of TTFields therapy, and our plans to achieve profitability.

With that, I'll turn to Ashley to provide an update on our regulatory and clinical progress.

Thank you, Bill. Earlier this year, we had an exciting presence at the ASCO Annual Meeting where data from PANOVA-3 were presented during the Saturday evening plenary with concurrent publication in the Journal of Clinical Oncology. In July, the PANOVA-3 results earned a second podium presentation at ESMO GI, where the quality-of-life data was described in greater detail. PANOVA-3 demonstrated Tumor Treating Fields' ability to extend survival and preserve quality of life in pancreatic cancer, yet another aggressive solid tumor where Tumor Treating Fields has shown a benefit.

In August, we submitted our PANOVA-3 data in a PMA package to the FDA for the treatment of unresectable locally advanced pancreatic cancer. The filing was accepted, and we are currently in the substantive review phase with our FDA 100-day meeting scheduled for mid-December. The review is proceeding as anticipated and in line with our previous experience, we expect FDA approval mid next year. In September, we also initiated the PANOVA-3 filing process with European regulators and are currently preparing our filing in Japan. The pancreatic cancer treatment landscape is similar to GBM where effective therapeutic options are extremely limited. Feedback from leading pancreatic cancer physicians and advocacy groups on the PANOVA-3 data has been consistently positive, and we look forward to the opportunity to treat pancreatic cancer patients as soon as possible.

Moving to brain metastases. We presented the final data from our Phase III METIS trial in the plenary session at the 2025 ASTRO Annual Meeting in September, and these data were concurrently published in The Red Journal, the leading publication of the radiation oncology community. ASTRO is an important conference for Novocure as it hosts the largest gathering of radiation oncologists annually, a group of physicians that historically have best appreciated the benefits of Tumor Treating Fields therapy. This year, the METIS presentation was 1 of only 5 plenary selections out of 2,500 submitted abstracts, underlying the community's interest in our METIS data. There is a palpable excitement among radiation oncologists in the potential of Tumor Treating Fields to better control brain metastases given their experience using Optune Gio to treat GBM.

The first 2 modules of the brain metastases PMA have been submitted to the FDA. We received questions from the FDA regarding our second module, and we are working to close these questions out swiftly. We are prepared to file the third and final clinical module as soon as those questions are resolved. Our timeline for the full PMA submission is unchanged, and we continue to expect to complete the filing by year-end 2025. Like the pancreatic cancer filing, we expect a 9- to 12-month review once the clinical module is accepted by the FDA with the final decision anticipated in the second half 2026.

As Bill discussed, the investments in our lung launch have established the infrastructure needed to launch both the pancreatic cancer and brain metastases indications upon regulatory approval. We expect to launch these 2 new indications by leveraging our existing sales forces. The team detailing GBM will detail brain metastases and the lung sales force will detail our pancreatic cancer indication. We also see significant opportunities to leverage our medical education efforts, creating synergies across tumor types that accelerate awareness and deepen engagement within the medical oncology community. We expect our existing infrastructure to provide a strong foundation for these new indication launches without the need for substantial additional investment.

Turning to product development. An enduring reality of virtually all cancer therapies is a trade-off between extending survivals and the burdens and side effects of receiving cancer care. An overarching goal of our product engineering efforts is to minimize any potential burden of the Optune users' experience, either through improved devices or complementary offerings. We are pursuing projects to improve the therapy experience for cancer patients and physicians across all indications and expect to improve the Optune experience…

[Technical Difficulty]

Ladies and gentlemen, please standby, your call will resume momentarily. Once again, ladies and gentlemen, please standby, your conference call will resume momentarily. You're back online, you can resume.

All right. I am going to pick up at the product development conversation. Okay. Welcome back, everyone.

Turning to product development. An enduring reality of virtually all cancer therapies is a trade-off between extending survivals and the burdens and side effects of receiving cancer care. An overarching goal of our product engineering efforts is to minimize any potential burden of the Optune users' experience, either through improved devices or complementary offerings. We are pursuing projects to improve the therapy experience for cancer patients and physicians across all indications and expect to improve the Optune experience in both the near and longer term.

Earlier this year, we launched a new patient app in the U.S., which provides patients and caregivers a central location to track their Optune Gio usage, reorder new supplies, access FAQs and contact Novocure. Over 78% of U.S. GBM patients are users of the new app, and we are now preparing to launch in our international markets.

On the physician front, we launched a new portal for GBM prescribers this year, which streamlines the prescription administration and ongoing care processes. Over 60% of our target sites are active on the portal and physicians and their care teams tell us that they are pleased with the simplified administrative processes. We also recently submitted our updated MAXPOINT GBM treatment planning software for use with the HFE arrays to the FDA and expect approval in upcoming months.

As a reminder, the MAXPOINT algorithm uses patient MRI scans and physician inputs to create individualized optimized array placement maps as a function of the electrical properties of a patient's brain tissue. MAXPOINT received a Category III CPT code in July, and we plan to launch it as a product enhancement subsequent to FDA approval.

On the array front, we have rolled out our HFE arrays in all material markets and expect to fully complete the global rollout by year-end. We are also in the process of bringing many of the HFE array design elements and materials components into our next-generation torso array, which we expect to submit to the FDA for approval next year. As a medtech company, we have the unique opportunity to increase adoption and advance patient outcomes from both product and clinical development.

Of note, we have 2 clinical readouts expected in the first half of next year. The Phase II PANOVA-4 trial in metastatic pancreatic cancer should report out in late Q1 of next year. And the Phase III TRIDENT results in GBM will follow in Q2. PANOVA-4 will add to the existing pool of data exploring Tumor Treating Fields plus an immunotherapy chemo combination regimen, but for the first time in metastatic pancreatic cancer, which continues to be a devastating diagnosis for patients and their families.

TRIDENT studies the benefit of starting Tumor Treating Fields concurrently with chemo radiation in newly diagnosed GBM rather than waiting until after a patient's chemo radiation cycle ends. The goal of TRIDENT is to improve Tumor Treating Fields' ability to enhance the cancer cell DNA damage mechanisms of radiation. If successful, TRIDENT could enable radiation oncologists to prescribe Tumor Treating Fields earlier in a GBM patient's therapy journey than a standard of care today, something we know to be important. Data from these trials will further elucidate how Tumor Treating Fields can best be harnessed to improve the lives of patients diagnosed with these deadly cancers, and we are excited to share these results with you early next year.

As we look ahead to 2026, we are on the verge of becoming a true platform therapy company. With 4 indications expected in market by year-end 2026, our teams are excited about the opportunity to treat many more patients in need and continue our pursuit of profitability in the year to follow.

I'll now turn the call over to Christoph to review our Q3 financial performance.

Thank you, Ashley. We continued our positive momentum this quarter with net revenues of $167 million, an increase of 8% from the third quarter last year. This was primarily driven by year-over-year active patient growth of 5% in our GBM franchise, notably by strong performance in France, Germany, and Japan. We also had a foreign exchange rate tailwind this quarter of $3.3 million compared to the same period in 2024. We collected $3.1 million from Optune Lua claims in the quarter, including $1.6 million from non-small cell lung cancer collections in the period. As a reminder, reported revenues from non-small cell lung cancer reflect cash collections from approvals and positive outcomes from appeals in the quarter.

Gross margin for the third quarter was 73%. The reduction in margin is reflective of the global rollout of HFE arrays, the ongoing launch in non-small cell lung cancer, where we are treating patients prior to establishing reimbursement and increased tariffs. In the quarter, we also recognized a $2.9 million expense related to an inventory obsolescence provision for Optune Lua arrays.

Moving to operating expenses. Our research and development costs in the quarter were $54 million, an increase of 4% from the same period last year. We do not expect R&D expenses to increase materially this year as we ramp down spend on PANOVA-3 and METIS and reallocate those funds to KEYNOTE D58 and LUNAR-2.

Sales and marketing expenses in the quarter were $59 million, a decrease of 2% from Q2 of last year. This decrease was driven by lower share-based compensation expenses. As disclosed in prior quarters, we expect to leverage our current sales force to launch our pancreatic cancer and brain metastases offerings in 2026, pending FDA approval. G&A expenses for the quarter were $46 million, an increase of 15% from Q3 of 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional service expenses to support the greater company build-out, particularly in enterprise technology as we invest in our digital infrastructure to enable scale.

Net loss for the quarter was $37 million with a loss per share of $0.33. Adjusted EBITDA in the quarter was negative $3 million. While still negative for now, adjusted EBITDA is currently ahead of our internal plans for the year, driven both by solid revenues from our GBM franchise as well as constant prioritization of investments. We are committed to breaking even sustainably on an adjusted EBITDA basis in 2027 with the revenue contribution from new indications.

Our cash and investment balance at the end of Q3 was $1.034 billion. As a reminder, we have a $561 million in convertible notes that will come due in the coming days, which we will retire with cash from the balance sheet. We also closed on the second $100 million tranche of our credit facility this quarter. With the cash and short-term investments currently on the balance sheet and funds available through our credit facility, coupled with ongoing expense management, we continue to believe that we have the capital necessary to bridge to our next revenue streams in new indications.

At Novocure, we are on the cusp of expanding the reach of Tumor Treating Fields to patients in multiple solid tumor cancers. The discerning investments we are making today establish an infrastructure capable of treating patients in multiple indications. We look forward to the future treating more commercial patients in established and new geographies, 2 important data releases in the first half of 2026, and pending approvals in additional indications with high unmet need. And importantly, we are confident in our ability to achieve profitability.

We will now open the lines for questions. Operator?

[Operator Instructions] Our first question comes from Jason Bednar with Piper Sandler.

I wanted to start first here on lung. A few questions here. I'm just going to pack in. The launch in Germany and Japan, I know it's super early days, but any comparisons you can make relative to the launch trajectory you have here in the U.S. as we think about how those markets could scale relative to how the U.S. has performed? Anything that you can take with the slower ramp and adjust the go-to-market strategy outside the U.S.? And then I'm wondering if there are other factors outside of just physician education that might be helpful here in the U.S., such as securing reimbursement and/or inclusion in NCCN guidelines? Can you help me with where you stand on those fronts?

Great, Jason, this is Ashley. I'll start and talk a little about the global footprint, and then I'll ask Frank to jump in with the specifics in the U.S. I think really in Germany, what I would say is it's still very early days. We're just now entering into the beginning of our third quarter there and the summer periods in Europe are a thing. So as we look ahead, I would say, there is no new news coming out of Germany that we've seen that kind of differs from the dynamics we've seen in the U.S., both in the opportunities to continue to drive growth and in some of the challenges that may come in this education. But I would not point to anything specific in those early numbers and say it's early days, and our teams are there executing and building those relationships.

When we look ahead to Japan, we do think that this is a very different market for Optune Lua. We have received approval for Optune Lua in Japan, but we have not yet received national reimbursement. That means our field teams are able to begin the physician education process, but the real launch dynamics will come to bear when we do have physician reimbursement, which we anticipate in upcoming quarters. But it is a market we believe will be different for us and an easier market to launch in for a couple of factors that Bill mentioned on the script.

The first of which is that there is just a much higher prevalence of lung cancer in Japan. The second of which is the Japanese physicians are more comfortable using device-based therapies, I would say, across the board. The third of which is that we have a local standard of care, which is extremely comfortable using ICI across all settings, both first and second line. And on the top line growth format, because we have a single national payer, once we get reimbursement, we're able to see that active patient growth translate to bottom -- to top line and bottom line growth quite quickly. So we are preparing for that launch. And again, we're quite hopeful that it will be materially different than the trajectory we've seen in the U.S. and Germany.

Hello, Jason, this is Frank. Thank you for the question. To pivot back to the U.S. and talk about learnings and tactics, I think one thing we would acknowledge is in the launch, we initially pursued large volume academic practices where you do see large populations of Stage IV non-small cell lung cancer being treated because, obviously, you're trying to go after the patient volumes that you can capture. And the challenge that we found in that setting is that, #1, they're just not comfortable with devices as a starting point. And so you're introducing a new workflow, a new modality into the practice.

What we have found more effective as we pivot is in those larger volume practices, you can find the doctor who perhaps is seeing Stage III, but occasionally is consulted on Stage IV and is hyper interested in Tumor Treating Fields. And so we do have an example of one large academic practice where starting with somebody who is seeing 1 or 2 patients a month, they're now consistently prescribing 3 or 4 patients a month because they're pulling them in from the med on practice. And so we're trying to lean into that tactic right now of not necessarily finding the doctor with the highest volume, but finding the highest interest and their willingness to be an advocate within their practice to pull it in. So thank you, and happy to provide more color.

Maybe just as a quick follow-up, anything on commercial reimbursement to get updated on and anything on NCCN guidelines that we should be monitoring? And then as a follow-up, and this has been pivoting hard, but in Spain, I know you referenced that as a market that has a different structure to it. It's going to take maybe a little bit longer than France to ramp up. I think probably maybe a bit more normal or comparable to Japan back in the day. But I guess with the trajectory of that adoption, is that something we should expect to be linear? Or is it more back-end loaded? How to think about that ramp-up when it starts happening?

Yes. So Jason, this is Ashley. On the NCCN guidelines, just as a reminder, we submitted at the end of last year. We know that the package and the application was reviewed in early July, and we would expect the updated guidelines to be published in the upcoming months. We really don't have any more insight on the progress there beyond that. I will note that in the commercial setting, which is where we're now able to submit for reimbursement and approval, we are seeing, honestly, approval rates above our internal expectations. So this is going well. In lung, the payers are responding to the strength of the data. We would expect that to continue to be the case in all scenarios.

I think the real unlock on the reimbursement side for lung will be Medicare, of which the NCCN guidelines is a key input, but it's not the end of that journey. So I think commercial reimbursement going well. Medicare, a much longer journey, which we started and which NCCN guidelines will support.

In Spain, I think it is a good reference to the Japan rollout of Optune Gio 7 years ago because we do have to contract hospital by hospital despite the national reimbursement. So it really is, I would say, in an administrative processing phase. Time will tell. What we said is that we think it won't flip on overnight, but it will ramp up over the course of a couple of years. And I think it will be a continuing driver of top line growth for us, both in the active patient numbers and in revenues over the next 2 years.

Our next question comes from Vijay Kumar with Evercore ISI.

This is Kevin on for Vijay. I have a few more questions on lung. You've talked about the launch being behind expectations. Are you able to share what your initial expectations or targets were for lung? And second, on LUNAR-4, would you say this termination is at all connected to your latest views on the lung cancer market broadly? And lastly, if you can share the year-to-date spend on that program before it was terminated?

Yes, Kevin, this is Ashley. Thanks for the question. Unfortunately, the answer to all of those is, I would say, no, meaning we're not able to share that level of detail, and we're not sharing the internal launch expectations. What I will say, though, what we can say is that we always knew that this would be a slower ramp than it would be if we were a little white pill. We know that across our device. Linear growth was what we anchored people to. And now what we're saying is we knew it would be hard. It's somewhat harder than we would expect it -- than we expected, but we do continue to look ahead to growth. And again, I would point both to ongoing trajectory in the U.S. and Germany and to hopefully a step function increase in that growth from Japan. So that's where we are with LUNAR overall.

With LUNAR-4, the story there really is about actually the disciplined investments and what we were able to save by looking at the ability to gather that data from real-world evidence, which, in the U.S., I will remind you that approximately 90% of our patients on Optune Lua for non-small cell lung cancer have had prior ICI exposure. So we are able to look at the real-world evidence and the experience in the U.S. and publish over time that data to answer a very similar question than LUNAR-4 was asking. So we do know it is still a very relevant scientific question. We are committed to kind of exploring that question, but it is a far more cost-efficient way and for us to do that through real-world evidence.

Yes. Vijay -- Kevin, sorry, this is Christoph. Just to add to what Ashley said, the savings that we expect is in the mid to high single-digit million. So it's actually a quite worth achievement.

Our next question comes from Jessica Fye with JPMorgan.

This is Tanmay on for Jess. My first question is we now know that active patients for non-small cell lung cancer grew to 100 in 3Q. But given the sequential decline in prescription, could you probably just expand on the underlying dynamics there? And second question would be if you could expand on the gross margin trajectory? And over what time horizon can we think about that recovering or maybe even exceeding historical levels?

Sorry, could I just to clarify the first question around prescription and patient volumes? Didn't quite…

Yes. So for the non-small cell lung cancer, we now have 100 patients in 3Q. However, we see a sequential decline in prescription volume. So could you maybe just expand on the underlying dynamics there?

So thank you for the question. So yes, we -- what we do see is that we focus internally, our big focus is on active patients. There's always a bit of noise in prescription volumes because it's a question of some practices write prescriptions before they've really educated the patient. Some practices only write the prescription when they're ready for the patient to start. And I think we need a few more quarters in lung cancer before we really settle into what a fill rate would look like. So for right now, I would ignore the noise around prescriptions.

I can take the question on gross margin. So we had -- maybe just to take a step back, in the quarter, we had a gross margin of 73%. At the beginning of the year, what we said is what we would expect during the year is the gross margin to come closer to lower 70s, driven by a couple of headwinds. One is the rollout of the HFE array. Two is -- basically was the lung cancer indication where we launched before getting reimbursement. And then there was another headwind that came to it, it was tariffs. So if you now look at it all together, we're actually pleased with the cost reduction journey that we have been able to accelerate on the HFE arrays. So as a result, for this year, we see the gross margin get closer to kind of the mid-70s as opposed to the lower 70s.

Now when we look ahead, our gross margin will be impacted by the launches and the launch trajectories. And it really comes back to the fact that in order to get reimbursement, for us, it's a process. It doesn't come with approval. And we will be starting to treat patients in markets where we expect to be reimbursed before we have the actual reimbursement. So there will be a lead time -- there will be a gap between starting off patients and getting reimbursement, and that will impact our gross margin. And quite honestly, the more successful we are, the more it will impact the gross margin during this transition period. Now I think what's important is we are somewhat in control of this because we can accept the patients or not accept the patients if you don't get the reimbursement in the time line that we want. And so our gross margin, there will be a little bit of noise as we go through the launches. We expect it to come back to higher levels when we are through this period, which is in the higher 70s.

And I would just say, in all scenarios, when we look at profitability as defined by adjusted EBITDA, we remain committed to that path and can see getting there throughout those launches.

Our next question comes from Jonathan Chang with Leerink Partners.

This is [ Evelyn ] on for Jonathan. So one more on the Optune Lua launch in lung. So you reported 84 unique prescribers. Can you provide some clarification on whether that's specific to Q3 or that's cumulative since the launch or something else? And then one follow-up, if I may, on profitability. Can you provide more color on what goes into your goal of breaking even in 2027?

So Eva, that stat is specific to Q3. So that's an easy answer. And I will point out the takeaway there that it's been consistent across quarters. And what we're seeing is that we're able to bring both new prescribers into the Optune Lua treatment journey, and we're retaining existing prescribers. So when we think about that mix between new and returning, we see about a 50% split there, which is a nice trend as we look ahead. And I will also remind everybody, when we look at the profile of patients we're getting, we are seeing that patients approaching 90% of them have prior ICI exposure. So we're also seeing it used in a combination that we know is relevant.

Yes. And sorry, on the adjusted EBITDA, your line was a bit same. What exactly was your question?

Just more color on what goes into your goal of reaching the breakeven in 2027? Yes.

Yes. Okay. So first, I'd say this is really no change in messaging. I mean this is very consistent with our commentary in the past. What we said is that we would expect to breakeven on an adjusted EBITDA level at a revenue of around $700 million to $750 million. And the range is really explained by 2 main items. And the one is the level of R&D expenses, which is driven by the pace of enrollment in Phase III trials in essence. And 2, the dynamics that I just talked through in terms of during launch years, we have an impact on gross margin. Both levers are in our control. And so again, we expect to breaking even on an adjusted EBITDA level at a revenue level of $700 million to $750 million, and we expect this to be during 2027, we'll be there on a sustainable basis, meaning up to then, we could be close as this quarter, we were very close, minus $3 million. And we believe we'll be sort of bouncing around this breakeven on adjusted EBITDA level. During 2027, we believe we will be on a sustainable level.

Our next question comes from Emily Bodnar with H.C. Wainwright.

I guess on the lung side, I was curious with how the launch is going currently. Do you have any kind of internal changes to your expectations for what the opportunity could look like at peak and kind of more color on how we should be thinking about ramp maybe for next year? And also what learnings you've had from the launch so far that you can kind of use to make sure the pancreatic launch doesn't kind of fall into a similar pattern?

Emily, that's a great question. I'll start with a little bit of what our expectations are internally and then ask Frank to provide some of the learnings. But zooming out, lung is hard, but we do know it's worth it given the opportunity, both long term, but also across the entire portfolio. And the incremental cost for spinning is actually quite negligible when we look at the investment we would be making today versus the investments we need to be making for pancreatic and brain mets as we look ahead. So we have adjusted our internal expectations. We are making sure that we have motivated field teams that are focused on the right targets driving growth. But I will say when we look at investments, the investments we have made are investments in the platform, and they will establish that infrastructure that will treat the full portfolio over the next year.

So while we're always looking at those discerning investments, I will say we really are now looking at the platform. And again, we're confident that those are the right ones as we look to this path to profitability with top line growth coming from 4 products on the market in the end of the year. But I'm going to ask Frank to provide specifics on pivots in the market.

Yes. So thank you. So first, to go to the question around how do we view the long-term value. We still see the long-term value in helping non-small cell lung cancer patients. There's a tremendous unmet need in the second line. And as we look even further ahead to the LUNAR-2 trial, there's a huge opportunity within first-line treatment. And so for us, given the data set that we have, we believe we have a compelling reason to be in this market, helping the patients. In terms of learnings and pivots, I think Bill in his opening noted on the need for education and additional evidence as you work into a new community of doctors. And so on the education front, I think, one, we have the advantage that we are in market already.

So physicians are hearing about our lung indication, but by extension, when we go into and have approval to actually market to panc, they won't be naive to the messages. #2 is to take a direct learning from lung in terms of the education that we need to do, I'd say we've learned that we need to educate not just the physician, but the practice, the nurses, the physicians' assistants and really everyone in the practice on the therapy because you don't know where the patient will direct their question, the first question about the device. And so I think that's in the real tactical side of things, but it's things that we now know we need to do to be successful in our next medical oncology launch.

And then Bill also mentioned the need for continued evidence generation. I think one thing we've done for panc is ensure that at FDA launch, we're also in the process of closing out the PANOVA-4 data set. So trying to take those learnings and really lead towards an excellent launch in panc.

And I'm not showing any further questions at this time. I'd like to turn the call back to Bill Doyle for any further remarks.

Thank you, Kevin. I'd like to conclude the call where I began. Everyone in Novocure comes to work every day to help patients extend their survivals in these really aggressive cancers. We've been working very hard for years to help patients with GBM, and we are now excited and in the middle of our preparation to become a true platform company, serving, again, patients in 4 indications by the end of next year. Our pipeline is on track. We were very pleased with the clinical recognition we've received for PANOVA-3 and METIS. And on the financial front, again, we expect now 4 diversified revenue streams, and we're committed to marching forward toward profitability. So we have an exciting 15 months ahead, 6 major country-level launches, 2 important data readouts, and meaningful product improvements that we continue to focus on and we'll be rolling out.

So with that, I want to thank the Novocure team for all their hard work and for your attention and support today. Thank you.

Ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.

Good afternoon, everyone, and we appreciate you joining us for a fireside chat with NovoCure. I'm very happy to be joined by CEO, Ashley Cordova. Thanks for coming, Ashley. Hope the conference has been productive for you. I'm Kelly McCarthy. I'm from the Morgan Stanley Healthcare Banking team and really appreciate everyone who's joining us this afternoon. So I just want to kick off, maybe we can start high level, and you can give an overview of what you're focused on at NovoCure today.

Yes. Thank you. So thank you, Kelly, for having me and for the chance to start on. At NovoCure, we have one very clear and simple mission. Together with our patients, we're striving to extend survival in some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields. So we have one platform therapy, and we are heads down focused on bringing that to as many patients as possible.

Now practically, what does that mean? At this particular phase in company building, we are transitioning from a single indication company with a very significant business in GBM, which generates $600 million in revenue and on its own merits, a significant amount of cash flow to a multi-indication platform. And as we look ahead, exiting 2026, we believe we will have 4 products in hand, a diversified revenue stream across those products and a clear path to profitability.

Okay. Great. And you are in a new seat at the company as of the beginning of the year. So in the CEO seat now, how do you think about the vision for the company? How you change that, maybe redefine that a little bit in your new seat?

Yes. So again, what hasn't changed is this mission and commitment to the platform. What we have focused a significant amount of energy on is just the basic organizational building and kind of strengthening of the capabilities to make sure that we have the teams in place, the ways of working in place to scale up and deliver the value of a multiple indication platform with the leverage in the P&L that we have today, right? So we believe we can do that.

We have the field teams in place that we need to detail both indications that are in market today. And those same 2 teams will cover all 4 products as we exit next year. But we're really taking the time this year. It's a bit behind the scenes, but to make sure that we have the organizational strength and the kind of focus on scaling that we need to actually effectively accelerate top line growth and deliver it in a profitable manner. And the second point I will say is that a very clear commitment to profitability. We will make targeted investments, and we will make the trade-offs we need to make so that we do take this path to profitability.

Okay. I want to click into some of the indications that you've already gotten approval in and then some of the pipeline as well. But I guess, as you sit in your seat today, what rises to the top in terms of your priorities, both from a development perspective, commercial perspective, et cetera?

Great. So we have to start with GBM because that is the indication that we have in hand now 10 years post launch and really is a fantastic business. As I said, $600 million in revenues. It's a mid-single-digit growth engine. That's what we've anchored people to, and that's what we see ahead as well. But it's also a very stable foundation upon which we can, with confidence, make the investments we need to in the future.

Before I talk about that future, I want to also spend 1 minute talking about the value of just the experience that we have in the go-to-market model in GBM. We know how to not only develop this product, but actually bring it to patients. We have a DME that we have a device support specialist model that goes into the home of the patient to train them. We can do that at scale. We have a reimbursement engine and a revenue operations team that is able to actually get paid on this product at scale. And all of that process know-how we've learned in GBM will translate through to future indications. So that's the strength and kind of the solid foundation that we've built in GBM. And as we look ahead now, again, by the time we exit next year, we would expect to have 3 additional products in market. One, Optune Lua for non-small cell lung cancer, the second in pancreatic cancer and the third in brain metastases from non-small cell lung cancer.

And I've joked that we used to get asked before we have the clinical data, which indication was our favorite, and we would laugh and say you can't have a favorite child. And now I will tell you that with these indications clinically derisked and with that in hand, I definitely have a favorite child. And my favorite child is pancreatic cancer. And I think lung is my problem child, right? It doesn't mean it's not a loved part of the family, but it is certainly our most challenging indication, and that's the one we're launching in market now. And brain mets, I think, is going to be -- offer material upside and accelerate growth is probably the indication we're talking the least about with investors. But one of the ones we're talking the most about with our investigating community just given the interest and the fact that the radiation oncologist knows us so well. So again, high level, we're exiting next year with these 3 indications. All of them are clinically derisked. All of them offer a significant clinical benefit in an area of high unmet need, but they do have some puts and takes in how we're going to bring them to market.

Okay. Let's go deeper into some of these specific indications. You talk about GBM, is your beachhead in terms of your commercial franchise. You've captured very strong market share in GBM, as you mentioned. The growth has slowed a little bit in recent years. So what is your strategy for driving that next leg of growth?

Yes. The takeaway that we want everyone to have with GBM is that it is a stable and durable engine of mid-single-digit growth, right? So we're now at that phase of launch where it is just the basic blocking and tackling of continued sales force execution and overlaying some geographic expansion as we look to penetrating deeper in Europe. You just heard us announce in August the Spain reimbursement. And I think that's an example as France was a driver of growth for us over the last 2 years. We would expect as France is approaching maturity that Spain will layer on. And in aggregate, we're looking at a mid-single-digit growth engine, which generates a significant amount of cash flow, as I said, if we were to strip out the R&D activities.

So it's not that there is a kind of hockey stick of growth coming up, but there's a lot of confidence that we have in how we think about measuring future investments knowing that we have this stable growth engine there. There is one trial which will read out in the front half of next year that could change that trajectory, and that is the TRIDENT trial. This looks at the potential to extend survival if we start Optune Gio with radiation 2 months earlier in the treatment journey than we started today. And if we are able to demonstrate a significant survival benefit there, we would expect to get 2 months of incremental duration on those patients, which is material as we build per month of therapy. And it also puts Optune Gio more squarely in the hands of the radiation oncologist who is our best customer set.

So we're looking ahead with excitement to that data set. But I would say the takeaway from GBM is it's the steady eddie kind of engine of mid-single-digit growth that gives us strength to invest in other indications.

So mid-single digit on a global basis?

Correct.

Okay. And then you mentioned the trial is going to read out the first half of '26, TRIDENT. Does -- can you talk a little bit about the benefit of moving earlier into newly diagnosed GBM patients? Does that expand the pie? Does that improve the actual benefit to the patient? I assume it does. How are you thinking about -- is it more clinical benefit? Or is it also commercial benefit in terms of size of the opportunity?

Yes. No, this is a clinical benefit. We're looking to see if we can extend survival for newly diagnosed patients. Our indication today is a newly diagnosed. So we're already first line and newly diagnosed. You can't go earlier in the kind of patient pool. But these patients today start their treatment journey post surgery with radiation, right? They get 60 gray radiation. And the question we have is if we start concomitant with that radiation, can we extend survival even further versus what we see in the control arm, which will be ourselves started post radiation with the other standard therapies. So this truly does look to see, can we bring incremental clinical benefit by starting earlier.

Now we have a strong scientific rationale to believe we can, else we wouldn't be running the trial, and this is because we know Tumor Treating Fields inhibits DNA damage repair. And so while radiation is quite effective, we are also quite good at repairing the DNA damage overnight in between those radiation sessions. And that is really the question we're asking is, can we make the impact of radiation better such that we further extend survival. If we don't show a significant benefit here, the label will stay as it is today and people would start postradiation as they do today.

Okay. Got it. And is there another Phase III trial here?

We are enrolling in a trial called KEYNOTE D58, which looks at the potential to significantly extend survival when you add KEYTRUDA or pembrolizumab to the regimen. I will remind everybody that the pembro trial in newly diagnosed GBM did not succeed when it did not have Tumor Treating Fields in that backbone standard. But we know from our preclinical experience to date, and we've seen in several clinical settings that Tumor Treating Fields induces an immune response. We see immunogenic cell death. And because we know we can do that in the brain, we are hopeful that the combination will open up glioblastoma to the effects of IO. We have a Phase II trial that Dr. Tran ran that supports this trial design, and we're very excited for that trial to be open and enrolling.

Okay. Anything else you want to say about the GBM opportunity before we move to NSCLC?

No. I mean I will just remind everybody that this is our beachhead and it is a fantastic business. As I said, $600 million in revenue that generates a significant amount of free cash flow on its own feet and one that we're very pleased with and provides us confidence as we look ahead.

Okay. So going to lung cancer. You launched in second-line non-small cell lung cancer last year. Can you talk about the early quarters of launch? What has the big challenges been?

Yes. So as I noted upfront, of the 3 launch indications, we always knew lung would be the hardest, and it is, in fact, the hardest is how I would summarize it. We are able to get in front of this position with a message of clinically meaningful data in a patient population with high unmet need. The data discussions are going very well, but this is simply a very crowded and competitive space with the rapidly evolving landscape and the ability to capture mind share and relevance in such a competitive space is hard, right?

This is also the first time we are detailing medical oncology community with our device-based message. And we are a device in a drug-based world. And I think that we knew that education would take time, but it's, I would say, taking twice as long as we thought it would. So what does that mean? It means that the launch -- the facts on the ground are that the launch is behind expectations, and we have not seen meaningful growth. But we do know that the investments we're making in this education will bear fruit across the portfolio. And this is the question we ask ourselves all of the time is as I look at the portfolio of opportunities and the education around Tumor Treating Fields in a medical oncology setting, particularly as I look ahead to pancreatic cancer, this call point is valuable and this time spent in office detailing is valuable, but the lung launch itself has been behind expectations.

Okay. So the launch has started in the U.S. and Germany. How are you thinking about further geographic expansion, particularly in bigger markets like Japan or France?

So Japan will be next, and we do believe there will be a material opportunity in Japan. Japan under-indexes in GBM, just in East Asian populations, the incidence is lower in GBM, but over-indexes in non-small cell lung cancer. We believe we will have approval by end of this year and reimbursement to follow a couple of quarters later. That is a national payer. So when you get reimbursement in Japan, it is a switch that turns on. And as we're able to drive demand, we are getting paid for that demand. So as I look ahead, we are focused on Japan. France will come with reimbursement. We will not launch at risk in any additional markets.

Just on that topic, can you give an update on the reimbursement dynamics in the U.S. and Germany where you've already launched?

So the reimbursement will largely be gated to Medicare for lung in the U.S. because Medicare is 75% of the payer population. We have submitted for an LCD reconsideration, but that process takes, we estimate approximately 2 years. In the commercial setting, things are ahead of expectations, actually. What we are seeing is that while demand is behind, actually, the payer dialogue is going very well. And it speaks to, I think, the relevance of the data that when you're sitting in front of somebody and having a conversation about the unmet need in the data, this is a very easy conversation. And so we are confident that we will get there. We are seeing very good progress in the commercial setting, and we're standing by that estimate of approximately 1 year to reimbursement in commercial and 2 years in Medicare. And I would say that applies to future indications as well.

Okay. Very helpful. I want to talk a little bit about LUNAR-4, which is a Phase II trial that was being run in lung cancer that was suspended. What should investors take away from that update?

Yes. Thanks for the question because I think this actually specifically points out our commitment to a path to profitability and our willingness to kind of rechallenge assumptions that we had in the past. We know that there is a very relevant scientific question on what is the overall survival signal when you are looking at an ICI retreatment or rechallenge in a previously ICI-treated patient. This is where the market is, and we know this is a very relevant question. That's why we started the LUNAR -4 trial.

We also know that in the U.S., 90% plus of our patients that are starting Optune Lua have had prior IO. So we have an ICI retreatment population in our commercial patient population today in the U.S. And this was always a signal-seeking trial. It was Phase II. So it was not powered to be registrational. And so the ability to look at real-world evidence in the U.S. and answer that question is a much more cost-effective and transparently quicker answer to that question. So we're pivoting not away from that question, but we're pivoting to the source of that data, and we will answer that question and real-world evidence in the U.S. And I think, again, this is just an example that's making the trade-off so that we can keep that cash on the balance sheet and our path to profitability.

Got it. Okay. Let's talk about some of the new indications and particularly your favorite child in pancreatic. You just filed the PMA in pancreatic cancer in August, and you plan to file in brain mets later this year. So how do we think about approval timing? How do we think about the path forward to commercialization there?

Yes. So the PMA submission for pancreatic cancer went in on August 15. It is a 180-day clock, but that clock stops any time the FDA asks questions, and there will always be some questions back and forth. So our guidance is to assume 9 to 12 months to approval from submission, which would put us at summer of next year. We are prepared preparing to launch, I would say. As I noted, it's the same field team that covers Optune Lua today that will be detailing the pancreatic indication in the U.S. So effectively, they're already in their training sessions, but they're out there in their day jobs detailing Tumor Treating Fields in a different indication. So we'll be ready.

MET is a modular submission. Modules 1 and 2 are with the FDA. We've had our presubmission meeting on Module 3, and we're around the corner from that submission as well. So that would put that launch in the back half of next year. Again, we're doing all the work that we need to prepare campaigns. But similar to Optune Lua, there is an overlap in the field force that covers Optune Gio that will detail the metastatic indication.

Okay. So -- the overlap on the salesforce seems very helpful, but...

It's -- this is how we get the leverage. We have the teams we need in all of our major geographies.

I guess what would you say for that -- those teams, those 2 teams, respectively, what the learnings have been? Or maybe even what could have -- what they could do differently than what was done in lung cancer?

Yes. I love that question because there have definitely been some learnings, right? And I'll start with the statement that we are a device in a drug-based world. We know that, but we're just constantly reminded of that, right? So what it means is that you need to go in with a little bit of a device-based marketing spend. And I think in oncology, we're used to leading with the overall survival benefit, right? That's what sells, right? The data cells. We're realizing and we're learning in lung, and we'll capture this learning as we look ahead that we probably need to start with an explanation of what is the device.

And actually, in our early engagements, things as simple as like having the device in the room so that the prescriber can actually tactically see it and touch it and explore it, that matters, right, which is a very simple shift, but it's not intuitive if you're thinking about the power of your overall survival data out the gate. So we'll take the time to do the device education. And that's certainly a lesson learned, and I think we're learning the best way to do that. I think we're also learning of the power of that peer-to-peer kind of hyperlocal device-based education where in a traditional -- I'll just use an example, speaker bureau, a physician might want to hear from a national KOL explain and contextualize the data. That's always helpful. But in this setting, we're realizing that, that prescriber might benefit more from a conversation with the radiation oncologists down the hall from them that treats GBM that can talk about how they've integrated Tumor Treating Fields and Optune into their practice.

So making those hyper-local connections to make sure that we have peer-to-peer dialogue around the device, that's a lesson we've learned and will carry forward to future indications. I also think there's just a platform effect that comes with when you have multiple indications that are on market, there is a little bit of a halo. We often say it's either the same physician being detailed both indications in the community setting or they share the same water cooler. And they probably share the same waiting room, and they're going to see patients wearing the device across indication. And all of that helps just make it feel like a platform and not so unique to one indication.

And transparently from a durability of growth, the diversification of having 4 products in market, launching and growing at once also provides us the stability to not be so dependent on any one indication in any one quarter. We're going to be looking at how do we accelerate top line growth across the platform.

Absolutely. Yes. And I don't want to miss the PANOVA-4 readout that's coming in Q1, I believe. That's going to be a Phase II readout in pancreatic. Can you talk a little bit about what -- how that could be meaningful?

Yes. It is an exciting data set for us, and it will be out early next year. This is taking the combination of Gem Abraxane and Tumor Treating Fields into the metastatic pancreatic cancer setting and then also adding atezolizumab in IO. So you're looking at 2 interesting questions. First of all, what is the effect in the overall survival signal as the disease control rate signal when we add Tumor Treating Fields in the metastatic setting. Our current label will be locally advanced. n

And then it also looks at the incremental benefit from IO. And similar to the conversations we are having in GBM, pancreas is a tumor, a region of the body that has been privileged from the benefit of IO in the past. It's a cold tumor microenvironment. It has the protection of the stromal tissue and many of the systemic agents that would be used to activate the immune system do not penetrate the region. We believe that Tumor Treating Fields will be able to do this. So this is, again, a Phase II trial, but will be very interesting as a signal-seeking trial and the data will be very informative from where we go next, both in metastatic setting and an ability to combine with IO in pancreatic cancer. And I think this is very exciting to the prescriber community. If you -- for all of the advances that we've made over the last 2 decades, there have not been significant advances in pancreatic cancer, and they're ready and eager to kind of open up that tumor type to IO.

Okay. We'll be watching for that update. Ashley, I'm going to ask you to put your old CFO hat back on briefly. And I know you made a few comments about profitability and your goals in reaching profitability at the beginning. But I would like to just understand your current capital position. Does that enable you to reach that point? How you think about keeping the company well funded? And what does profitability mean for NovoCure?

So we are very committed to this path to profitability. And yes, we believe we can do it with the balance sheet that we have on hand. And I will say very strongly that we are committed to this path. What does that practically mean? Again, the easiest way to get there is through accelerated top line growth, and we can see that around the corner as we look at having 3 launch indications next year and 4 product portfolio as we exit next year. There's a significant amount of leverage, as I noted, pulling that through. The sales and marketing infrastructure that we need to support all 4 indications is already in our P&L.

So there will be some incremental spend as we support launch campaigns and the paid media associated with that. But we're really talking about small incremental spend. The vast majority of the SG&A infrastructure we need is in place today. If we need to, we can also control the lever of how much we put in R&D, right? So we are an oncology company looking to invest in our future. So we're not looking to slow down our investments in R&D. That's where the future growth comes from. But if the top line growth does not paint that clear path, we will make the adjustments that we need to make in order to get there. And I actually think LUNAR-4 is a perfect example of that at a small scale of the types of decisions we're willing to make. So that's how I can say with confidence, I see a path to -- we think of adjusted EBITDA as being that target that we would look to turn positive.

And when we think about capital structure, I mean, we have the balance sheet. We need to do this, right? Cash runway is not an issue as we look at being in control of the levers to control that path to profitability. And we're sitting on more than $900 million in cash today on the balance sheet. We do have a convert, which comes due by the end of this year. We expect that we will pay down that convert with the cash we have on hand. We have an existing credit facility in place. We've pulled $100 million of that. We are obligated to take on the second $100 million that will come on this quarter. So you will see us exiting the year, we believe, with more than $400 million on the balance sheet and the convert paid off, and that is sufficient to get us to where we need to go, we believe. And I could say, at a very personal level, I'm committed to that. This is something I know brings value, and this is probably the instance where my ex-CFO hat should give some investors some reassurance there.

Okay. Great. I just want to talk about where your stock is. Obviously, it's been a volatile year in biotech in general, and you're not alone in facing some bumps in the road. But what do you think investors should be focused on or isn't resonating and that they should be focusing their attention on about the story?

Yes. I think the messages are similar to what I've hit on before, but I think that is -- there are some simple messages. There's a couple of core facts that I just think are not appreciated in the current valuation. The first is we have an existing commercial business today in GBM that on its own 2 feet generates a significant amount of free cash flow. It is a mid-single-digit grower. It's not a double-digit grower, but it is a very kind of reliable engine of growth. That's the fact that we have in hand today.

And again, we're at the cusp of having a portfolio of opportunities to accelerate that top line growth as we look ahead with a clear path to profitability. And I just -- I do think there's a disconnect between those 3 facts and the valuation that we have in hand. I will say, I think it's a confidence issue, not a fundamental issue. And so then it's our job to execute, right? And we understand that. And as I look back through this year, I'm quite proud of the execution of the team. We've advanced the regulatory filings for pancreatic and METIS. We have gotten approval in Spain. We've delivered on the growth targets that we set ourselves in GBM. We have been on podium and concurrent publication at ASCO, and we're getting ready to be on podium at ASTRO with the METIS data. So the team is working very hard. They are focused. And I do think with time, that will bring value back to the story.

And I just want to go back to the point about the platform and Tumor Treating Fields because it is a very unique modality in biotech. So I just want to hear from you what gives you guys the confidence that, that is the right modality and the right technology to be investing in across these different areas? And what gives you confidence to keep pushing that story to investors who may not be giving you value for all these different indications?

I mean we know because we see the data, right? And we think that's -- and it's not just the clinical data we have in hand, but all of the preclinical data and the translational work. And I will also think that we used to have a message of broad applicability on top of whatever standard of care. And it is still true that actually our primary limitation is physical. There's not a certain biomarker or a certain tumor type that is not predisposed to Tumor Treating Fields.

But actually in a world of hypertargeted treatments, what we're realizing is that there's a very special role for a modality like Tumor Treating Fields to play, where you need the ability in some of these challenging microenvironments to have a different tool that is not just like the other systemic agents that you have that might help whether it's activate the immune system or deliver an antimitotic effect or help inhibit the DNA damage retail, where for some reason, all of the advances that we've had to date are not reaching that tumor. And we offer a totally different pathway, a physical pathway to get to that tumor and to, as I said, activate the immune system, which I think is the future, not only of the IOs that we have in hand today, but as we look ahead to the next generation of immune therapies. where a lot of the excitement will be. So I think we're well positioned because we are so uniquely positioned to bring something different that can be used in combination to help further extend the benefits that we see of the evolution and without competing toxicities. We don't have the systemic toxicities that you see in so many of the other combination products. And that brings real value when we think about needing to have a kind of a well-rounded armamentarium of tools to fight cancer.

Okay. Well, congratulations on all the progress across the pipeline. We'll definitely keep track of some of these upcoming readouts and regulatory updates. Before we close, anything you'd like to leave the audience with as a final thought or anything you're personally excited about in the company's future?

First of all, thank you. I know this is the end of a long conference. So thank you guys for being here still and for your ongoing interest in the story. The messages are clear. So I'll just reiterate them that we are really at a unique position in this company as we transition from a single indication to a multi-indication platform. That's not a dream or a potential anymore. These are kind of the execution points that we have in hand and the catalysts that we have in the near term as we look ahead 4 to 6 quarters. We can see accelerating top line growth with the 3 launches built on top of a solid business that we have established today with a go-to-market model that we know well, and we have a path to profitability. So I'm excited to help deliver this promise, and I hope you can hear that in my voice, and I look forward to updating everybody in conferences to come.

Great. Thank you for joining us. Hopefully, it's been a great conference for you to participate in, and we're looking forward to continuing to track. We -- when I met you, you were a single approval, single asset company. So it's been great to see you execute across the pipeline, and we're rooting for your success. So thank you for joining us.

Thank you, Kelly.

Good day. Thank you for standing by. Welcome to NovoCure's Second Quarter 2025 Earnings Conference Call. [Operator Instructions] 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 2 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 5-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 end points. 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 [indiscernible] all 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 1 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, session discussing Dr. Brian Wilpolm of Dana Farber, who played the role of objective reviewer said TTFields plus gemcitabine and nampatletaxel 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 2 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. We're the quality of life data from PANOVA-3 was described in greater detail. Patients treated with TTFields in gemcitabine and nab-paclitaxel to 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 confirm 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 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 2 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 driving trial in newly diagnosed GBM, studies the potential benefits of initiating TTFields therapy several months earlier in the patient's journey, concurrent with chemoradiation rather than after chemo radiation. PANOVA-4 is a Phase II trial that adds the immunotherapy atezolizumab to TT fields, 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 deals 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 time line once terms are agreed, similar to what played out in our GBM launch in France over the past 2 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 top line 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 public -- and the public comment period is complete, the MAX will issue a coverage decision. There isn't a statutory time line 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 the structure prospective 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 adoption and 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 3 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-total lung cancer and 2 additional launches within reach, the steps we will 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 onetime benefits of 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 HF rate and the continued launch of non-small cell lung cancer prior to 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 HF rate 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 import 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 spend on some large Phase III trials and ramp up spend 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 expense. 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 4 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 2 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 1 launch ongoing and 2 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 to the operator for questions.

[Operator Instructions] The first question is coming from the line of 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 -- that we -- that's been discussed before for 2025? And I had 1 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 we should take away is that the long 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. And 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 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. So let me just remind everybody what the METIS trial was studying. So in non-small cell lung cancer, brain metastases are one of these really significant markers of deterioration in the patients. About 25% of patients are actually diagnosed with brain mets when they're diagnosed with cancer, and at least another 25%. So this is a significant unmet need in non-small cell lung cancer. And in fact, the standard of care in stereotactic radio surgery followed by supportive care. So in Metis we studied the addition of tumor treating fields to supportive care after stereotactic radiosurgery. And the endpoint of this study was progression. All of our other trials, the endpoints are overall survival, where the endpoint is very specific and very binary. In this case -- and this is Larry common in other trials where radiographic review is part of the analysis that a first read is presented. And then through the standard cleaning of data, a final data set is provided. We're, of course, delighted that the data considered continued to be very statistically significant and very 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. Jason, this is Frank. So thanks for the question. I would just start again with the baseline for this population, which is that there is a high clinical unmet need for second-line treatment in Stage IV non-small cell lung cancer. The physicians are not satisfied with the with what were the existing treatment options of docetaxel or docetaxel plus ramucirumab. And so we always start with the fact that we still feel very comfortable that we are going into a large market, and we see that in the numbers -- in our numbers where we see that 90% of our patients had been previously treated with immune checkpoint inhibitors. So physicians are comfortable using that full patient population with us, and they're accessing both sides of our label. So that's really where we really see the opportunity.

To the point of steepening the curve and really driving this launch now that we have some experience, I'd point to our refinement of our marketing messages and our refinement of our targeting of the population in that there are a very large percentage of patients who start therapy, go on a platinum therapy and either because of side effects or adverse events, they're unable to continue the platinum therapy. Now their disease may not have gone into a full progression. It may be, in some cases, even just a clinical progression where the patient is not feeling as well as they used to. And we're going to really lean into that message of saying once the patient is off the platinum, they are now eligible for Tumor Treating Fields. And I think that's really going to be an area for success for us, and that's really where we've seen some strong -- that's where we've seen physicians really building up patient volume. And so we're going to lean into that, and we think we have the opportunity to grow faster.

All right. Helpful. And then 1 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'll say -- I'll just remind everybody that tried into the trial in newly diagnosed GBM, which is studying the overall survival benefit of starting tumor treating fields earlier in the treatment journey concurrent with radiation rather than waiting to post chemo radiation, which is the current label. The trial reads out in the first half of next year. And we're excited to see clearly the data here because, first of all, it provides a real benefit to extend survival even further, but also positions the therapy earlier in the treatment journey with a real potential upside in duration. It's too soon to get specifics on actually what that will mean from a regulatory and reimbursement perspective because it depends on the data. What I will say is that this will be easier than a de novo PMA. It is an earlier start of our existing our existing label. And I would say that would extend to payer dynamics as well. The same coverage policies that apply newly diagnosed would need to incorporate this data, but I think it is it's an easier hurdle to cross than it is when you're starting with a new indication. So too soon to get specific because the data will drive those discussions. But we're very hopeful and excited about this trial.

Okay. We'll wait on that. And then maybe if I could squeeze in 1 more, just on the NCCN guidelines. I don't know if there's any way to handicap it, but just how do you think category a versus 2 versus 3 ultimately influences commercial coverage?

Yes. It's probably too soon to handicap other than to say anything is helpful and the higher in the category rating, you could go to more helpful, right? So I think anything -- even being on the guidelines in any calculation is a step-up from where we are today. With additional publications, we'll continue to work our way up those guidelines. So I think that's important that it's not kind of where you start is where you end. Certainly, publication volume matters here. And we're as eager as everybody is to see those updated guidelines published later this fall.

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

I had 2 from my side. One maybe on ASCO PANOVA, [ biller ] actually, what was the reception at ASCO. If you could just elaborate on the physician feedback and compare contrast us with your prior pull-in presentations at ASCO.

Maybe I'll start is 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 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, and 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 it the hub up, but this is highly anticipated at this point.

And then the only other thing I would add, Vijay, is that we were front page of the ASCO daily news on Sunday, which is a lot of fun. And new for us. And I would also say that, that extended into the discussions. ASCO is 1 event. It's great to see that energy and excitement, but we really needed that to continue onto the ongoing physician dialogue, and we've seen that I was at ESMO GI in Barcelona last month when we were presenting the quality of life data. And I will say -- it's a lot of fun to go to these congresses. When physicians are walking up to you already aware of the data, excited about the data and talking about next steps and where we can go from here.

That's helpful. Then maybe 1 for Christoph. On the revenues here. I think your 10-Q had some details on revenues recognized from our performance obligations for prior period service tender. I know there is a CMS backlog payments one-offs, which comes in from time to time. What was GMS 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 the Q2 of this year. Last year, there was a higher percentage and hence, we called it out.

Understood. And sorry, you say CMS, is CMS back part of this? Or is that separate?

Yes. It's not really a key revenue driver of the prior period came 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 time frame 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 probability. 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 time frame. 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 over 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 the 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 DPL to GNP, standard of care, you don't have added adverse event, which means it's highly combination ball, 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, nappaclitaxel in metastatic [indiscernible] 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?

Yes, this is Ashley. I'll try to answer both of those. And then if we follow up, I'll hand it off to Christoph. But the first it's an easy answer, it's actually the form factor of the submission. So I'll remind you that with METIS, we have a modular submission, so modules 1 and 2 went in, in April this year to the FDA. This was an important pathway because it's actually the first time this device is under review at the FDA. It is our Torso application, but at 150 kilohertz -- pardon me, yes, at 150 kilohertz which is our lung cancer frequency.

So those 2 modules need to get through at the FDA to approval before we're able to submit module 3. So that's simply the gating reason. We're in productive discussions. In fact, later this quarter, we will have our pre-submission meeting with the FDA that's scheduled for the clinical module, but the pacing of it will actually be dependent on modules 1 and 2 getting through the review process. And then that final module will just see the clinical module. So that's -- it's a very straightforward and easy answer. To the second, I would just remind everybody that this is not new. So this is disclosure, you can actually go and look at over the prior kind of years. And I would -- we've always seen it in line of this 3% to 5%. And any time it bubbles up above that, we call it out in the script. So I would say I wouldn't try to model this anymore. This is well baked in, in our rerated has been since the implementation of [indiscernible]

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

I want to follow up on [ Optune's ] specifically the positioning as more of a post the 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.

Well, I'll start just on the -- to start at the end with the payer note. I will say, I think we've seen some initial progress with payers that what I'd really attributed to again is back to the point that this is an area of high clinical unmet need. -- and the doctors see it and the payers see it. Looking at in terms of the positioning and the link of the positioning to NCCN that -- we don't necessarily see a key link there. We have to fit into the guidelines as the NCCN has already published them. So we're not trying to influence the way in which they present their guidelines. That said, what we are doing and you'll begin to see soon is that we're publishing real-world evidence around the patient population that we have treated commercially and really using that to shape physician perception of where to use the device and ultimately, over time, to then push that deeper and deeper into the community, this idea once you're post platinum and you're thinking about what do I do at the first time the patient is not doing well, go to Optune.

Great. And then just as a follow-up in prior calls, you discussed the potential opportunity for U.S. commercial decision on Optune Lua potentially in 2025 based on the I guess, potential timing of NCCN guideline release. Is that still the right way to think about the pace of dialogue with major U.S. payers or you'll perhaps enter 2026 a more realistic assessment.

Yes, Kevin, I mean, listen, it's not a binary switch. First of all, these ramp up over time. And what you've seen is that we're seeing early successes. So we had $1.1 million in this quarter, and I think we would expect each quarter to add a few sizable number to that target to get to where we would exit 25% with -- not in immaterial but not a significant amount of money from Optima in the U.S. And we think we're on track for that, and we would expect really the full driver of top line growth appearing in 2026. So exiting with strength in '25 and really seeing material 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 includes all of the revenue inclusive of the Optune. So that's both Optune Gio and Optune Lua. And yes, we do -- I mean the U.S. and Germany are the 2 markets that we have the opportunity to go and see case-by-case reimbursement. So it will follow us similar trajectory in Germany, as we're seeing [indiscernible] in the U.S.

Got it. Okay. Makes sense. And then I know it's probably still pretty early, but are you able to comment at all about efficacy you're seeing in real-world cases for lung cancer and how that's kind of related to the LUNAR trial, particularly in the patients who had prior immune checkpoint inhibitors.

This is Frank. Thank you for the question. I would say we're not able to track to overall survival. So we can't comment on a hard clinical end point. But what we do see is that usage of the device is consistent with what we saw in the trial, which is our best proxy to say these patients are using it the same way. And we're -- and as I said, we're seeing physicians who have now had patients on from the launch quarter. So we're pretty far into it, and they're expressing a strong confidence in building a practice with more and 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 and 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 1 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 kits. We're busy. It's exciting and we look forward to keeping you up-to-date in future calls.

Ladies and gentlemen, that does [indiscernible] conference for today. Thank you for your participation, and you may now disconnect.