Transcript: NovoCure Q2 2026 Earnings Conference Call

NovoCure (NASDAQ:NVCR) released second-quarter financial results and hosted an earnings call on Thursday. Read the complete transcript below.

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The full earnings call is available at https://edge.media-server.com/mmc/p/xxyc7dbi/

Summary

NovoCure reported a strong second quarter 2026, with record net revenues of $184 million, marking a 16% year-over-year increase, driven by growth in Optune Gio, Lua, and Pax.

The company observed significant growth in active patients, with an 11% increase in Optune Gio and successful launches of Optune Lua in Japan and Optune Pax in the U.S. and Germany.

NovoCure updated its full-year revenue guidance to $710-$725 million and aims to achieve profitability by focusing on revenue growth and cost management, including a redesigned LUNAR-2 trial to save $90 million.

Strategic focus is on expanding the use of Tumor Treating Fields (TTFields) in new cancer indications, particularly pancreatic cancer, with plans for additional trials and IDE studies for combining TTFields with RAS inhibitors.

Management expressed confidence in continued growth and profitability, highlighting the positive reception of Optune Pax and Lua, and maintaining an enterprise-wide focus on achieving break-even adjusted EBITDA by year-end 2026.

Full Transcript

OPERATOR

Good day and welcome to NovoCure's second quarter 2026 earnings call. At this time all participants are in listen-only mode. After the speaker's presentation there will be a question-and-answer session. To ask a question you will need to press star 11 on your touchtone telephone. Please note this call is being recorded. I would like to turn the call over to Adam Daney, Head of Investor Relations. Please go ahead.

Adam Daney, Head of Investor Relations

Good morning, and thank you for joining us to review NovoCure's second quarter 2026 performance. I'm joined on the phone today by our Executive Chairman Bill Doyle, CEO Frank Leonard, Chief Innovation and Medical Officer Uri Weinberg, and CFO Christoph Brackmann. For your reference, slides accompanying this earnings release can be found on our website, www.novocure.com, on the Investor Relations page under Quarterly Results. 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 non-cash 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, net income, without reasonable efforts.

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 this morning, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.

Bill Doyle, Executive Chairman

Thank you, Adam. This morning we reported our second quarter 2026 results, and I am pleased to say this was our strongest commercial quarter to date with record net revenues and active patients on therapy. We continue to build on the momentum of the first quarter and have also made meaningful progress on our path to profitability. I will begin this morning with a review of our commercial results. Frank will then provide an update on our clinical strategy.

Christoph will conclude our prepared remarks with a review of our quarterly financial performance before we open the line for questions. All three of our approved products contributed to our commercial performance this quarter. Starting with Optune Gio, we finished the quarter with 4,636 active patients on therapy, an increase of 11% year over year. A key driver this quarter was U.S. growth, where active patients increased 8% year over year. In recent years, we have implemented a number of strategic and structural changes to our U.S. commercial operations that are now bearing fruit. We also saw double-digit year over year growth in Germany, Japan and in our Global Markets group. We are pleased with the Optune Pax launch to date. We received 418 prescriptions in the quarter, and 285 Optune Pax patients were on therapy as of June 30th. We have successfully completed our early launch objectives to engage, train and support prescribers who are familiar with Optune Pax from pre-approval clinical presentations of the PANOVA-3 results.

We were encouraged by the adoption of Optune Pax at both academic and community practices. From here, our teams will focus on generating consistent repeat prescriptions and engaging physicians who may be less familiar with the clinical data supporting use of Optune Pax. To close on the U.S. Optune Pax launch, I note that our interactions at this year's ASCO conference confirmed that the PANOVA-3 survival data is viewed as important and relevant for patients with locally advanced pancreatic cancer.

Earlier this month we received CE Mark for Optune Pax for the treatment of adult patients with locally advanced pancreatic cancer of exocrine origin, concomitant with gemcitabine and nab-paclitaxel, in accordance with local guidelines. We have since finalized labeling and registration in Germany and begun certifying prescribers. The reference to local guidelines in our label reflects the fact that nab-paclitaxel is not approved for locally advanced pancreatic cancer at the EU level, whereas nab-paclitaxel is recommended for use in the country-level clinical guidelines of many European countries.

Turning to Optune Lua, we finished the period with 207 patients on therapy. The early signals from the Japan launch are consistent with our previously stated expectation that clinical practice patterns in Japan align more closely with our label than other Optune Lua markets. As a reminder, we received national reimbursement in March and began certifying physicians soon after. As of June 30, we had 64 Optune Lua patients on therapy in Japan. We are still in the early phase of the launch in Japan.

While the established reimbursement policy covers all Japanese patients, additional contracting is required at each treatment site. As more hospitals and prescribers are contracted in the coming quarters, we expect Japan to be our leading Optune Lua market. Finally, the FDA review of Optune Maya for the treatment of brain metastases from non-small cell lung cancer remains on track for a Q4 decision. Earlier this month, the NCCN updated guidelines for the treatment of brain metastases and included Optune Maya as a category 2N, a recommended treatment option for patients with limited brain metastases from non-small cell lung cancer without targetable mutations. We are pleased that the NCCN opted to include TTFields therapy and believe this will be helpful for a future launch pending FDA approval. With three devices launched and a fourth under FDA review, we are in the favorable position of having multiple products contributing to growth in the coming years. We are focused on achieving the regulatory and market access milestones required to bring tumor treating fields therapy to more cancer patients in more regions as quickly as possible.

Frank will now walk through some of the updates to our clinical programs.

Frank Leonard, Chief Executive Officer

Thank you, Bill. We are entering a new phase of clinical development at NovoCure. Historically, our clinical strategy has focused on areas of significant unmet need and opportunities to establish TTFields in new cancer types. With three products approved and one under FDA review, we are shifting that mandate to focus on strengthening our market position and broadening labels. Our near-term focus is pancreatic cancer. Optune Pax is currently approved for first-line use together with gemcitabine and nab-paclitaxel in locally advanced pancreatic cancer, which is classified as stage 3.

Our primary goals are to solidify our position in the locally advanced setting and explore TTFields therapy use in earlier stages of the disease where the tumor is or may be resectable. We are designing additional sponsored trials to support label indication in both locally advanced disease and earlier stages of pancreatic cancer. We are also in active negotiations with industry partners to explore the concomitant use of TTFields therapy with either RAS inhibitors or other innovative approaches to treat pancreatic cancer in pilot trials focused on feasibility and early efficacy signals.

This approach is grounded in extensive discussions with prescribers, key opinion leaders and the preclinical results showing promising signals from the concurrent use of TTFields and KRAS inhibitors. We believe this focus will best position Optune Pax to remain integral to the evolving standard of care in pancreatic cancer. In addition, we are preparing to open an IDE trial for concurrent use of TTFields therapy and diraxan rasib following its expected FDA approval.

The intent of this trial will be to generate safety and feasibility data quickly and provide physicians with clinical data to evaluate how best to use the two therapies. Moving forward, we do not intend to open a registrational trial in metastatic pancreatic cancer at this time. We are also continuing our efforts to increase the data supporting use of TTFields in our approved indications for GBM and non-small cell lung cancer. The KEYNOTE D58 trial is on track to complete enrollment by year end, with database lock and top-line readout approximately two years later.

KEYNOTE D58 is a phase 3 trial exploring the addition of pembrolizumab to the current standard of care of TTFields therapy and maintenance chemotherapy for GBM. Turning now to non-small cell lung cancer, LUNAR 2 is a phase 3 trial exploring first-line use of TTFields therapy, pembrolizumab and platinum-based chemotherapy for the treatment of metastatic disease. We have initiated several changes to this trial with the goal of lowering total trial costs and accelerating the pace of trial completion.

The first step was the optimization of our clinical footprint. We are in the process of reallocating clinical resources to high-engagement, high-enrolling sites and discontinuing the trial at lower-enrollment sites. The second step is to amend the protocol to streamline the trial's primary endpoints with the goal of reducing the patient sample size. We believe these changes will cut the total spend on LUNAR by approximately $90 million, with the savings allocated to pancreatic cancer programs.

The refreshed focus of our clinical program should be beneficial on several fronts. First, it will enable faster data generation, address potential data gaps and provide flexibility to remain ahead of the evolving standards of care. Second, these changes allow us to balance ongoing R&D investment at our current level with our goal of reaching profitability in the coming years. Finally, I want to express my thanks to all the NovoCure employees for their hard work and dedication to achieving our goals.

We have started the launch of Optune Pax, refocused our R&D efforts, and implemented operating expense discipline to ensure we have a clear path to profitability. We made great strides towards these goals in Q2, and I'm incredibly proud of what the team has achieved overall this year. I'll now pass the call to Christoph to review our financial performance in the quarter.

Christoph Brackmann, Chief Financial Officer

Thank you, Frank, and thank you all for joining us this morning. We continued our strong start to the year in Q2. Net revenue in the second quarter was $184 million, an increase of 16% year over year. The increase was driven by Optune Gio active patient growth of 11% year over year as well as increased contributions from Optune Lua and Optune Pax of $5.4 and $1.6 million, respectively. We benefited from $3 million in one-time items driven by increased approval rates and age claims in Germany, lower annual deductible reset impact in the U.S., and performance improvements in France.

The exchange rate impact versus Q2 of last year was overall immaterial, with some benefits in Europe being offset by the Japanese yen. Based on the strength of our commercial performance in Q2, we are updating our full-year revenue guidance to a range of $710 million to $725 million, representing 8% to 11% growth. We are also updating our guidance range for combined revenue from Optune Lua and Optune Pax to $20 to $30 million for the year. Gross margin in the quarter was 78% compared to 74% in Q2 of 2025.

This was primarily due to a tariff refund of $5 million as well as lower array costs due to improved utilization and manufacturing efficiencies. We expect quarterly gross margins to remain in the mid-70s through year-end 2026 as we bring more Optune Pax patients on therapy prior to establishing broad reimbursement. Research and development costs in the quarter were $51 million, a decrease of 8% compared to the same period in 2025. The change was primarily driven by lower direct trial costs associated with Phase 3 trials that have concluded as well as lower costs associated with the LUNAR-2 trial.

With the redesign of our LUNAR-2 trial, we are confident that we can keep R&D costs at or below current levels in the future while being able to invest in our clinical development aspirations. As outlined by Frank earlier, Sales and Marketing expenses in Q2 were $62 million, up 8% from Q2 2025. The increase was primarily due to costs associated with the ongoing launch of Optune Pax in the U.S. and Optune Lua in Japan. G&A costs in the quarter were $40 million, a decrease of 9% from the same period last year.

This was primarily driven by lower share-based compensation expenses. Our net loss for the quarter was $16 million compared to $40 million in Q2 2025. Loss per share in the quarter was $0.13. Adjusted EBITDA in the quarter was $11 million compared to negative $10 million in the second quarter of 2025. We are updating our full-year adjusted EBITDA guidance this morning to a range from $0 to $15 million. Our cash and investment balance as of June 30, 2026 was $441 million.

We are unambiguous in our enterprise-wide focus on reaching profitability in the coming years. This includes driving strong revenue growth as well as diligent expense management and the pursuit of cost-optimizing projects like the LUNAR-2 trial. In recent years, we have made the infrastructure investments required to support the commercial operations of Optune Gio, Lua, Pax, and MAIA. As these launches continue to gain momentum and net revenue continues to grow, we expect to see significantly greater leverage across the P&L, providing a tailwind to profitability.

The first milestone in our path to profitability is to reach break-even on an adjusted EBITDA level, which we now plan to achieve for the full year of 2026. Thank you all for joining us this morning. We'll now open the line for Q&A.

OPERATOR

Thank you, ladies and gentlemen. As a reminder, to ask a question, please press star one one on your telephone, then wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Ajay Kumar with Evercore. Your line is open.

Ajay Kumar, Analyst at Evercore ISI

Hi guys. Thank you for taking my question. Congrats on the nice print here. Maybe my first one on this pancreatic launch. Strip volumes up sequentially in the triple digits, active patients up north of 200%, I guess. Can you give us a little bit more flavor on where is this growth coming from? How many docs are prescribing currently? Is this coming from existing physicians or new physician adds? And when you think about that sequential trajectory — looks really strong — is this sustainable here for back half?

Like how should we think about pancreatic launch, continued adoption, if you will, for the back half?

Frank Leonard, Chief Executive Officer

Hi Ajay, thank you. This is Frank. Appreciate the question. And we'll start by noting that we are pleased with the launch in pancreatic cancer. As a reminder, for Q1 we really only had one month of activity. So in looking from Q1 to Q2 on pure statistics, it is absolutely a strong quarter in terms of statistical growth. But to give it the color and the context that you asked about, I would say that we have been, first and foremost, very pleased with our ability to interact both at community practices as well as academic practices.

And so in terms of the sites that we're training and certifying, we're seeing that breadth across different types of providers. We are not giving context right now on the total number of certifications, but I would say that from a color perspective, we've been able to get access to the practices and to ensure that we can get certifications done quickly. We are right now looking at about half of our prescriber base has already become a repeat prescriber, with the other half having initiated treatment once.

And we think that at this point in the launch is pretty common. We have a big set of physicians who are interested, and as with any new modality, there's that interest to get it on one patient to try. And then the challenge for us as we move forward, to answer the part of the question about the future as we look ahead, one of our major focuses for Q3 is that we need to push that number of repeat prescribers up and go from "trying Optune" to "Optune is integrated in my practice."

Ajay Kumar, Analyst at Evercore ISI

That's helpful, Frank. And maybe one more on Pax. I think I heard you say you'll start an IDE trial for TTFields plus RAS inhibitors. I'm curious, when you look at these early data that you have, when you compare to early data that you've had in other indications, what gives you the confidence here on TTFields plus RAS — we're seeing a positive signal that gives you the confidence to start this IDE trial. And I think I've heard you mention this is going to be an IDE but not a registrational study, right?

Like, why not? You know, why is this an IDE, not a registrational trial? And at some point in the future, do we need a registrational study for TTFields plus RAS inhibitor?

Frank Leonard, Chief Executive Officer

Yes. Thank you. Yes. So to highlight what we've announced on this call is that we do see interest and, in fact, a need to open a trial where physicians can use TTFields plus a RAS inhibitor. The fastest way to do that is after divarasib has its FDA approval. We can do that through an IDE trial. As you noted, and as I'll re-emphasize, we are opening this trial in order to look at safety and feasibility signals, as these are both two new modalities.

And we are really looking at it from that perspective of safety and feasibility. And we are not, in metastatic disease, looking to move towards a registrational trial or indeed to a larger trial with hard efficacy endpoints. I'll let Uri speak in just a moment to some of the preclinical rationale, but what I will say is that as we spent time at ASCO and, in fact, as we've interacted with our prescribers, we do just see the clinical interest in answering the question of how can you use these two therapies together.

And so we believe we need to work as fast as possible to begin addressing that question.

Uri Weinberg, Chief Innovation Officer & Chief Medical Officer

So from a scientific perspective, we have been able to publish already that TTFields therapy in the preclinical setting led to the downregulation of c-Myc, which is a master regulator of cancer cell proliferation and metastasis. And c-Myc, being downstream of RAS in many cases, has the possibility of influencing the overall silencing of this pathway, leading, when using TTFields therapy concomitantly with KRAS inhibitors, to an overall greater and maybe even synergistic effect.

And this has been reported through our preclinical results and has actually been reproduced also by Mayo Clinic in independent research that was conducted by their research team. These findings were published in the recent AACR conference. Now, on top of the opportunity to get the clinical data as soon as possible by utilizing and using the fact that KRAS inhibitors are primarily going to be approved in metastatic disease first, this also secures and promotes our communication and advancement towards partnerships with other commercial companies in this field.

And we are working in this direction, too.

Ajay Kumar, Analyst at Evercore ISI

Great. Thank you, guys.

OPERATOR

Thank you. Please stand by for our next question. Our next question comes from the line of Jason Bitnar with Piper Sandler. Your line is open.

Jason Bitnar, Analyst at Piper Sandler

Hey, good morning, everyone, and congrats on another nice quarter here. I also wanted to start on the pancreatic indication. Like Ajay, Frank, can you talk a bit more about prescribing patterns, patient acceptance, and conversion from Rx to active patients? And particularly on that Rx conversion to active patients, are we at a point where we can begin to use the experience thus far to inform how we think about the model and future conversion?

Frank Leonard, Chief Executive Officer

Thank you, Jason. In terms of the prescriber patterns, as I mentioned earlier, right now we are seeing about 50/50 of prescribers who have tried it once and those who have used it multiple times. We expect over the coming quarter to continue broadening out the number of prescribers, but we will focus in this quarter on driving up the repeat prescribers because if you think about the effort on our side and the effort on the physician side to use the therapy for the first time, once you've cleared that hurdle, it's really a time to consolidate the engagement with the practice and drive up the volume.

And I say that because, as I looked at our prescribing patterns for this quarter, one thing that does jump out is that we have, in terms of our highest-volume sites, for the first time, it's both a mix of community and academic practices. Whereas I think, as you know, in the past we've sometimes had challenges getting into these large academic practices, we're not seeing that this time around either. So to sum up on prescribing patterns, I think it was a good effort in the first two quarters of the launch to get to the physicians who are interested.

It was a good effort to get as many people prescribing as possible. We're seeing repeat prescribing in 50% of the population, and we're seeing access to academic sites in a way that we haven't seen before. In terms of modeling fill rate or conversion rate from Rx to start, I would say because it's a launch and because it was the first full quarter, I wouldn't begin trying to glean specific statistics from the numbers. I think you'll need a little bit more time from a sample size perspective.

Jason Bitnar, Analyst at Piper Sandler

Okay. All right, thanks for that. Maybe one follow-up, and I've got one for Christoph too here. I'll just pack them both together. But on the fill rate, conversion rate, is there a reason to think Pax is different from Gio longer term — just anything structurally or about that indication that you think we should be using or assuming different fill rates? And then Christoph, the business is definitely establishing a better revenue execution pattern here — another guidance raise, second of the year.

I guess the question though, even with the raise, the high end of the revenue guide implies a growth decel and absolute revenue that's on par with what you just put up in 2Q. So maybe help me. Why is that the right level? It seems like we should be even higher than where you took things.

Frank Leonard, Chief Executive Officer

Jason, on the fill rate question, I don't think I would draw a direct connection to GBM or a reference point yet to the patient population just based on the chemo regimens. We really do—I think even we would say this to ourselves—we need a little bit more time to really see where the fill rate settles. What I would say, though, is that it's a shorter time between prescription and start than what we typically see in GBM, and we do see really motivated patients.

So I don't want to draw a conclusion one way or the other, but I also don't want to raise any alarms that we think it's going to be very low, I guess is what I would say.

Christoph Brackmann, Chief Financial Officer

Okay. And thank you, Jason, for the revenue question. So maybe first as background, we increased the net revenue guidance from 690 to 710 million to today 710 to 725 million, which would be a range of 8 to 11% in growth. And the midpoint is double-digit growth, 10% growth. So we're very happy, based on the strong performance in Q2, to be able to, what I would call, substantially raise our revenue guidance. Now with regards to your point on the high end of the revenue guidance is basically in line with the Q2 results.

Two answers. So one is we called out 3 million in one-time items in Q2, and the other one is, I would say, Q2 was really an exceptional quarter where we had sales of 10 million more than in the prior quarter, or 9 million if you compare to Q4. So really, we would say the stars aligned in Q2, particularly also with having a very strong growth in the U.S.—8% year-over-year active patient growth in the U.S.—and you know that that has a fairly substantial impact on revenue.

So long story short, we are very focused to achieve an outcome that is towards the high end of our guidance range. But we also wanted to respect that we had a fantastic quarter in Q2.

Jason Bitnar, Analyst at Piper Sandler

Okay, thank you both.

Frank Leonard, Chief Executive Officer

Appreciate it.

OPERATOR

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

Larry Biegelsen, Analyst at Wells Fargo

Good morning. Thanks for taking the question. Congrats on a nice quarter. So I wanted to ask about Lua in Japan, which was strong in the second quarter. Was there pent-up demand, and how should we think about that going forward? It does look like, when I—Christoph, when I look at the guidance for Lua and Pax, it almost seems to imply Lua revenues flat in the second half of the year if Pax is growing. And I had one follow-up.

Christoph Brackmann, Chief Financial Officer

Yeah. So maybe first on Lua and Japan in general. We are very pleased with the launch, and we had the hypothesis that our data from Lua overlaps better with the standard of care in Japan than in other markets. And that, I think, has proven to be the case. Now, we do expect sequential increase in patients, I would say, particularly with Lua. The duration in the clinical trial was about four months, so growth will at some point get more difficult. But we do expect sequential growth.

And with the revenue guidance, I would just say for the new products it's very difficult to project. And yeah, maybe the other point for Japan specifically is we have national reimbursement, but we have to work through a contracting process hospital by hospital. And while we do make significant—and have made significant—progress in Q2, that's a gating item, and it's just something that the team will need to continue to work through.

Larry Biegelsen, Analyst at Wells Fargo

That's helpful. And then maybe, Frank, back to Optune Pax. Once the RAS inhibitors are approved, which is expected shortly, do you think they'll be used off label in earlier stages of pancreatic cancer? And what are clinicians telling you about their willingness to prescribe both the RAS inhibitor and TTFields in the same patient before you complete this IDE you talked about today? Thank you.

Frank Leonard, Chief Executive Officer

Thanks, Larry. Yes, I mean I think just as a company that's committed to innovation, I'll start by noting that we're very happy that there's going to be another therapy approved for pancreatic cancer patients. Even with the success of sotorasib and adagrasib, still talking about median overall survival of approximately 13 months in their indication. And so we think there's still more to be done. And as with all of our indications, we think that tumor treating fields is particularly capable of being a backbone therapy as new medical therapies come to market due to our low toxicity profile—non-systemic toxicity specifically.

What we're hearing from our KOLs and our prescribers is that there is an interest in understanding how to use tumor treating fields with RAS inhibitors. I'll note, as you know, Larry, we are approved in locally advanced pancreatic cancer, and they will be coming to market in second-line stage IV, so later stage and in the second line of treatment. And I think it's too early to predict an exact impact of what will happen in the real world because there are payer dynamics that will be at play too, in addition to clinical dynamics of how RAS inhibitors are introduced.

But I think we're very confident based on everything we've heard to date that within locally advanced pancreatic cancer—our indication—that there's strong interest in tumor treating fields. And whether it's RAS inhibitors or new agents, we'll have to continue studying tumor treating fields with them and building that evidence for clinicians.

Larry Biegelsen, Analyst at Wells Fargo

Thanks so much.

OPERATOR

Our next question comes from the line of Jess Fye with J.P. Morgan. Your line is open.

Jess Fye, Analyst at J.P. Morgan

Hey guys, good morning. Thanks for taking the question. Another one on Optune Pax. I was trying to infer from your comments about the mix of one-time prescribers versus repeat prescribers so far, but figured maybe just ask you directly: what's the total number of prescribers who are sourcing those 418 Pax scripts in the quarter? Thank you.

Frank Leonard, Chief Executive Officer

Thanks, Jess. We haven't given the specific number of certified prescribers, and we think—we've talked about whether or not to give that number. There's some nuances there because it's a different, you know, not all prescribers are the same. Some are super high volume. Some are a doc who mostly does lung cancer but occasionally does pancreatic cancer. But what I can say is that the range of prescriptions within a practice right now ranges between one—they've tried it once—and some practices have written more than 10; some doctors have written more than 10 prescriptions. And that's really why, when we look at this 50% of prescribers who have only written one prescription, we see tremendous room for growth if we can drive them to that higher end, that point at which tumor treating fields—Optune Pax—is really integrated into their routine clinical practice.

Jess Fye, Analyst at J.P. Morgan

Helpful. Thank you.

OPERATOR

Thank you. Please stand by for our next question. Our next question comes from the line of Kevin DeGeeter with Ladenburg Thalmann. Your line is open.

Kevin DeGeeter, Analyst at Ladenburg Thalmann

Okay, great. Yeah, thanks for taking our questions. I'll just add another one on Pax. Can you talk a little bit about the go-to-market strategy in Germany and just kind of how we should think about the dynamics there for initial uptake and payment and reimbursement? Thank you.

Frank Leonard, Chief Executive Officer

Thank you, Kevin. I'll comment at a high level about the launch in Germany, and then I'll turn it over to Christoph to talk about our expectations. So Germany, much like the United States, allows for case-by-case reimbursement as new products come to market. And so much as we did in GBM, we are launching the product and then pursuing reimbursement on a case-by-case basis. We are, typically in Germany, going to focus on the large national cancer centers.

We are rolling out right now already our initial marketing and sales campaigns and really working on that effort to educate the largest cancer centers and begin certifying them. And then from there we would expect there will be a build. I think I would highlight that in Germany, we did not have as many of the direct KOLs involved in the trial, and so there is a bit of an education process that we will have to undertake. But much like in the United States, we've seen a belief in the data—that our data from the PANOVA trial was compelling, is clinically relevant.

And so we're excited for the launch, and we just have to now work through those reimbursement hurdles.

Christoph Brackmann, Chief Financial Officer

Yeah, maybe just some words on the total TAM. So incidence rates in Western Europe are quite comparable to the U.S. The TAM in the U.S. on label is 15,000 patients annually, and in Germany it's about a fourth. We expect it to be 4,000 patients on label. And as Frank said, we believe that the build will be at a slightly slower slope than in the U.S., but we're very excited to launch and we have started to do so.

Kevin DeGeeter, Analyst at Ladenburg Thalmann

Great. Thank you.

OPERATOR

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

Emily Bonnard, Analyst at H.C. Wainwright

Hi, good morning. Thanks for taking the questions, and congrats on the positive quarter. Maybe also on Optune Pax, if you can kind of discuss some of the early trends you're seeing, maybe in the initial patients that are getting on therapy, and also any feedback you're getting from prescribers with real-world use of the therapy. And maybe for second, you mentioned the combo of TTFields to RAS inhibitors—sounds like you're looking at mainly the metastatic setting.

I was curious if maybe you could also expand this into the locally advanced setting where you're already marketing. Thanks.

Frank Leonard, Chief Executive Officer

Thank you, Emily. I'll start with the second half of the question to just highlight that in our work to open trials with RAS inhibitors, there's two separate activities underway. One is an IDE trial focused on safety and feasibility, and that would be a trial run after sotorasib and adagrasib have FDA approval to enable us to do a trial with an FDA‑approved drug that would be within their label of second-line metastatic so that we can run that trial as an IDE trial and be the sponsor.

It's just the fastest way for us to gain access to the compound once it's approved. We are also at the same time pursuing business development discussions with industry partners to explore earlier-stage trials with both RAS inhibitors and some of the newer, more innovative compounds that are being tested in pancreatic cancer. So it is a both story. It's getting data with sotorasib and adagrasib as fast as possible and also looking at how we bring these innovative agents along with tumor treating fields to locally advanced pancreatic cancer and earlier stages.

And in terms of your question about some initial stories, feedback, I think there's a couple—kind of two stories I would share. I think one is we've been pleased with our ability to help a wide range of patients in terms of their physical capabilities and the concurrent therapies they may be receiving. What we've learned through this process is that not all pancreatic patients are the same. There's varying levels of disability from the disease, of fatigue from the concurrent therapies.

And I think what I'm particularly proud of is that our team has figured out how to help all those patients, keep them on therapy, and keep them progressing. And the second thing I would say—I'm talking with several of our KOLs, including one of our top prescribers very recently—we know from the PANOVA trial that pain‑free survival extended by six months for our patients. And we are hearing anecdotes from the physicians who are hearing it directly from the patients that there is an experience of pain‑free survival, that there is something happening that's beyond our ability.

From the data, we know we can extend overall survival, but we're, for the first time, starting to hear these stories from patients back to their physicians that they can actually feel the pain differently. And it gives us confidence that we're pulling through—that that six‑month observed pain‑free survival from the trial is, in fact, actually having clinical relevance.

Emily Bonnard, Analyst at H.C. Wainwright

Great. Thank you.

OPERATOR

Thank you, ladies and gentlemen. I'm showing no further questions in the queue. I would now like to turn the call back over to Frank Leonard, Chief Executive Officer, for closing remarks.

Frank Leonard, Chief Executive Officer

Thank you. Q2 was an exciting quarter for NovoCure. We reached new heights in both active patients and net revenues. We saw another strong quarter of growth in Optune Gio, an exciting introduction of Optune Lua in Japan, and continued the promising launch of Optune packs in the U.S. In addition to the positive commercial momentum, we have also made significant progress toward our objective of returning to profitability, posting a positive adjusted EBITDA result for the first time since 2024.

It's truly an exciting time for NovoCure as we bring the promise of Tumor Treating Fields to the more than 5,000 patients on therapy today. To the NovoCure team, thank you for your extraordinary work this year to help so many patients. We look forward to updating everyone on our progress through the remainder of the year. Thank you for joining us this morning.

OPERATOR

Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.

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