NovoCure - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 net revenues were $158.8M, up 6% year over year; diluted EPS was $(0.36), and gross margin declined to 74% from 77% on HFE array rollout, pre-reimbursement NSCLC launch dynamics, and tariffs.
• Revenue and EPS modestly beat Street: consensus revenue $154.2M vs. actual $158.8M; consensus EPS $(0.389) vs. actual $(0.36). Management highlighted FX tailwind ($3.8M) and continued GBM active-patient growth as drivers, while noting lower prior-period claim benefits vs. last year*.
• Operationally, total active patients reached 4,331; Optune Lua NSCLC ramp progressed with 121 scripts and $1.1M recognized from NSCLC collections, though the slope of U.S. prescriptions moderated sequentially and reimbursement remains case-by-case*.
• Near-term catalysts: PMA filing for PANOVA-3 (pancreatic) in Q3 2025 and METIS (NSCLC brain metastases) later in 2025; NCCN lung guideline review expected this fall—key to commercial coverage trajectory.

What Went Well and What Went Wrong

What Went Well

• GBM franchise growth and patient engagement: active Optune Gio patients rose 7% YoY to 4,194; total active patients reached 4,331. “This is a pivotal period for Novocure” as the company expands indications.
• Clinical validation and KOL support: PANOVA-3 met its primary endpoint; JCO publication and “Best of ASCO” inclusion; discussants from Dana-Farber and MSK signaled movement toward standard-of-care consideration.
• NSCLC early traction and collections: 121 NSCLC scripts in Q2; $2.4M Optune Lua recognized with $1.1M from NSCLC, plus broad label utilization (58% ICI, 42% docetaxel) indicating physician comfort post-platinum.

What Went Wrong

• Margin compression: gross margin fell to 74% from 77% YoY due to higher HFE costs, treating NSCLC prior to broad reimbursement, and tariffs; CFO guided full-year tariff impact up to ~$7M.
• Profitability remained distant: operating loss widened YoY and adjusted EBITDA turned negative as G&A rose 17% with stock-based comp and build-out for NSCLC launch.
• NSCLC launch slope concerns: analysts flagged slower sequential U.S. prescription growth and fewer prescribers; management reiterated launch is “on track,” refining messaging toward “post-platinum progression” rather than strictly second line.

Transcript

Operator (participant)

Today, thank you for standing by. Welcome to Novocure's second quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. 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.

Ingrid Goldberg (VP of Finance and Investor Relations)

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 statement except as required by law.

Where appropriate, we will refer to non-GAAP financial measures to evaluate our business, specifically adjusted EBITDA, a measure of earnings before interest, taxes, depreciation, amortization, and share-based compensation. We believe adjusted EBITDA is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material non-cash items, and 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 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.

Bill Doyle (Executive Chairman)

Thank you, Ingrid, and good morning. At Novocure, our mission is to extend survival for patients diagnosed with some of the most aggressive forms of cancer through the development of Tumor Treating Fields therapy. This quarter, we grew our commercial business and advanced our efforts to bring Tumor Treating Fields therapy to new patient populations. With the first half of 2025 complete, I am pleased to report we are making good progress on our clinical, regulatory, and commercial milestones. This morning, we will provide detail concerning recent PANOVA-3 data presentations at two key medical conferences, and we will review the next steps for our upcoming regulatory submissions of PANOVA-3 and METIS. We will also discuss our commercial performance in the quarter, and to close, we will review our quarterly financials and open the line for Q&A.

While our commercial teams pursue greater penetration in approved indications, we are working intensely to gain approvals in new indications. This quarter, we took important steps towards approval in pancreatic cancer. The five-year survival rate for patients diagnosed with pancreatic cancer is only 13%, and pancreatic cancer is often associated with debilitating pain, for which patients are quickly escalated to high doses of pain medications. Addressing these needs sets a high threshold for success in pancreatic cancer trials. We are pleased the PANOVA-3 trial proved the benefit of TTFields therapy together with gemcitabine and nab-paclitaxel for both of these endpoints. In May, we had an exciting presence at the ASCO annual meeting where data from PANOVA-3 were presented during the Saturday evening pancreatic cancer plenary session.

The PANOVA-3 findings were concurrently published in the Journal of Clinical Oncology, or JCO, and earned inclusion in Best of ASCO, which will be highlighted at regional ASCO meetings throughout the year. As a reminder, the PANOVA-3 intent to treat population in unresectable, locally advanced pancreatic cancer patients treated with TTFields together with gemcitabine and nab-paclitaxel saw a median overall survival of 16.2 months, two months greater than the control arm. In the modified intent to treat population of patients who received at least one cycle of therapy, patients saw an even greater survival benefit of over three months. TTFields patients also saw a benefit in pain-free survival, with a median time to increased pain in the intent-to-treat group of 15.2 months versus 9.1 months in the control group.

Following the presentation, session discussant Dr. Brian Wolpin of Dana-Farber, who played the role of objective reviewer, said TTFields plus gemcitabine and nab-paclitaxel would be an appropriate option for standard of care. Dr. Eileen O'Reilly of Memorial Sloan Kettering Cancer Center commented in the Journal of Clinical Oncology editorial that Tumor Treating Fields together with gemcitabine and nab-paclitaxel serves as a new standard paradigm in this patient population. These physicians from two of the top academic institutions in the United States are leaders in the treatment of pancreatic cancers and notably are new to the use of TTFields therapy. The PANOVA-3 results earned a second late-breaking podium presentation at the ESMO GI annual conference, where the quality of life data from PANOVA-3 was described in greater detail.

Patients treated with TTFields and gemcitabine and nab-paclitaxel saw improved global health status, significantly improved deterioration-free survival for pain and pancreatic pain, and significantly increased time to commencement of opioid use. PANOVA-3 showed TTFields' ability to extend survival, preserve quality of life, and delay many of the worst symptoms associated with pancreatic cancer. These clinical outcomes underscore the importance of TTFields therapy for these patients. 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 and supportive care compared to patients treated with supportive care alone. Following our initial data presentation at ASCO last year, the routine process of cleaning and qualification of the data was completed. The final analysis of the fully cleaned and qualified data set confirmed the statistical significance of the primary endpoint: improvement in time to intracranial progression with updated numerical outcomes.

Patients treated with TTFields therapy and supportive care exhibited a risk reduction of 28%, with median time to intracranial progression of 15 months compared to 7.5 months in patients treated with supportive care alone, with a p-value of 0.044. We intend to present the updated final clinical results at an upcoming medical conference early this fall and have submitted the manuscript for publication. Our teams are also working on the FDA PMA submission for brain metastases from non-small cell lung cancer. We submitted the first two PMA modules in April. We will be meeting with the FDA this quarter prior to submission of the final clinical module, which is on track for submission later this year. For both PANOVA-3 and METIS PMA filings, we expect a 9 to 12-month review following acceptance by the FDA, with potential approvals and launches to follow in 2026.

Our next clinical data readouts are anticipated in the first half of next year. The Phase III TRIDENT trial in newly diagnosed GBM studies the potential benefits of initiating TTFields therapy several months earlier in the patient's journey, concurrent with chemoradiation rather than after chemoradiation. PANOVA-4 is a Phase II trial that adds the immunotherapy atezolizumab to TTFields, gemcitabine, and nab-paclitaxel in the metastatic pancreatic cancer setting. Both trials are fully enrolled, and we look forward to sharing updates in the near future. With that, I'll turn the call over to Ashley to review our commercial progress in the quarter.

Ashley Cordova (CEO)

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 in 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 these same questions when we introduced Tumor Treating Fields to the GBM community. With this in mind, we have been cultivating peer-to-peer connections so practitioners new to Tumor Treating Fields can access physicians with years of Optune Gio experience. We have seen promising feedback from these peer-to-peer conversations so far and believe continuing to foster these relationships will pay dividends as new indications come to the medical community in the future.

We have also learned that many physicians view the best use case of Optune Lua as a replacement for platinum chemo at the first sign of radiological progression, rather than explicitly a transition to second-line treatment. This represents the smoldering progression population we have referenced throughout our market research. With this in mind, we are tweaking the physician messaging around Optune Lua to a post-platinum option rather than explicitly second-line therapy to better align with the way doctors view the patient treatment journey. Moving outside of the U.S., in late April, we received the CE mark for non-small cell lung cancer and launched in Germany with 15 prescriptions in the quarter. We are pleased with the early interactions with prescribers, especially pulmonologists, who take an outsized role in non-small 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 calendars swiftly. We also see similar dynamics of broad label usage and prior ICI exposure in Germany, as we have seen in the U.S. Japan is the next market where we expect to launch Optune Lua for non-small cell lung cancer. We are actively engaged in discussions with Japanese regulators and are hopeful we will have approval in hand in a matter of months. We believe Japan will be a strong market for non-small cell lung cancer, as incidence rates are higher in Japan than in many of our other major markets. Also, single-payer dynamics can expedite the revenue ramp timeline once terms are agreed, similar to what played out in our GBM launch in France over the past two years.

We are doing everything in our power to expedite the approval and reimbursement processes in Japan and look forward to providing more updates later this year. The next step in non-small cell lung cancer will be translating demand into 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 MACs.

Once an updated LCD is released and the public comment period is complete, the MACs will issue a coverage decision. There isn't a statutory timeline for review, but we estimate the review will take approximately nine to 12 months. Turning to our GBM business, we continue to march higher and finished the quarter with 4,194 Optune Lua patients on therapy, a 7% increase compared to last year. Each of our key markets, the U.S., Germany, France, and Japan, increased their patient count year over year, with all our ex-U.S. markets experiencing double-digit growth. We are also starting to see early reimbursement success in Spain. While the Spanish market is fragmented, we are encouraged by the progress. One of the avenues to drive GBM growth is ongoing evidence generation. This quarter, an independent retrospective study from the Mayo Clinic was published in the Journal of Clinical Neuroscience.

This study followed 374 GBM patients treated at Mayo Clinic locations between 2014 and 2023. Academic centers have not historically been the highest adopters of Tumor Treating Fields therapy, so it's notable to have a leading research institution like Mayo Clinic conduct this retrospective study. In this real-world study, patients treated with Tumor Treating Fields therapy demonstrated a two-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 Lua 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 in academic centers.

Before I turn the call over to Christoph to review financials from the quarter, I'd like to express my gratitude to the Novocure team for their hard work during this important year. The fundamentals of our business continue to strengthen each quarter. Q2 marks the 11th consecutive quarter of active patient growth. During that time, we've had three positive phase III readouts and 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 teams, and I want to applaud your efforts as we look ahead with urgency to extend survival for many more patients with some of the most aggressive forms of cancer. This is a pivotal period for Novocure.

With an established indication in GBM, the ongoing launch in non-small cell lung cancer, and two additional launches within reach, the steps we 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.

Christoph Brackmann (CFO)

Thank you, Ashley. We continued our positive momentum this quarter with net revenues of $159 million, an increase of 6% from the second quarter of last year. This increase was primarily driven by year-over-year active patient growth of 7% in our GBM franchise, including double-digit growth in all our international markets. The favorable year-over-year impact from exchange rates was $3.8 million in the quarter, offset by lower one-time benefits 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 HFE 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 HFE 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 impacts from imports from Mexico and Europe. Our current estimates indicate that the full-year PNL 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 expenses. Our thoracic sales forces in the U.S. and Germany are fully staffed and reflected in our year-to-date operating expense. Looking ahead, we expect modest incremental expense, primarily for marketing and in preparation for launch in additional countries. G&A expenses for the quarter were $44 million, an increase of 17% from the second quarter of 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional service expenses to support the non-small cell lung cancer launch and general company build-out, particularly on the enterprise technology side. Net loss for the quarter was $40 million, with a loss per share of $0.36. Adjusted EBITDA in the quarter was negative $10 million. Our cash and investment balance at the end of Q2 was $912 million.

We have $560 million in convertible notes that will come due later this year, which we intend to retire with cash on the balance sheet. Additionally, we have given notice of intent to draw the second of four tranches of $100 million each from our credit facility, which will close on September 26, 2025. According to the terms of our credit facility, we have an obligation to draw the first two tranches. With the cash and short-term investments currently on the balance sheet and funds available through our credit facility, we believe that we have the capital necessary to retire the outstanding convertible notes and bridge to our next revenue streams in new indications. As Ashley said earlier in today's call, this is our 11th straight quarter of active patient growth.

With one launch ongoing and two more on the horizon, we are continuing to build momentum and deliver on the promise of our innovative therapies. We believe we have the talent, infrastructure, and financial assets in place to bring new indications to market, gain reimbursement, and reach profitability in the years to come. I would like to thank you all for joining us on this journey, and we look forward to updating you on our progress later this year. I will now turn the call back to the operator for questions.

Operator (participant)

Thank you. Ladies and gentlemen, to ask a question at this time, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, simply press star one one again. Please stand by while we compile the Q&A roster. Now, first question coming from the lineup, Larry Biegelsen with Wells Fargo. Your line is now open.

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

Good morning. Thanks for taking the question. Ashley, the second quarter non-small cell lung cancer prescriptions in 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. 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 to $10 million range that's been discussed before for 2025? I had one follow-up.

Ashley Cordova (CEO)

Sure. Thanks for the question, Larry. I'll start off, then I'll ask Frank to add some additional color. I think the theme you should take away is that the lung 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 physicians. 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. With that, I'll ask Frank to add some additional color.

Ingrid Goldberg (VP of Finance and Investor Relations)

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

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

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 another analysis required? Thanks for taking the question.

Bill Doyle (Executive Chairman)

Sure. Let me just remind everybody of what the METIS clinical trial was studying. In NSCLC, brain metastases are one of the really significant markers of deterioration in the patients. About 25% of patients are actually diagnosed with brain metastases when they're diagnosed with cancer, and at least another 25%. This is a significant unmet need in NSCLC. In fact, the standard of care is stereotactic radiosurgery followed by supportive care. 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 very common in other trials where radiographic review is part of the analysis, 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 continue to be very statistically significant and very clinically meaningful.

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

All right. Thank you so much for taking the questions.

Operator (participant)

Thank you. Our next question coming from the lineup, Jason Bednar with Piper Sandler. He'll let us know.

Jason Bedner (Managing Director and Senior Research Analyst)

Thanks. Good morning. I'll double-click first on the response to Larry's question on lung. Anyone 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? We now have a couple of full quarters of data points here to work with. I hear you on the physician experiences and that 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, you know, balance this year and into future years, and feel free to respond in the U.S. and Germany as well.

Ingrid Goldberg (VP of Finance and Investor Relations)

Yeah. Jason, this is Frank. Thank you 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 what were the existing treatment options of docetaxel or docetaxel +ramucirumab. 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. Physicians are comfortable using that full patient population with us, and they're accessing both sides of our label. 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 is 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. 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.

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. We're going to lean into that, and we think we have the opportunity to grow faster.

Jason Bedner (Managing Director and Senior Research Analyst)

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

Ashley Cordova (CEO)

Thanks for the question, Jason. This is Ashley. I'll just remind everybody that TRIDENT is a 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 it 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 a 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 label, and I would say that would extend to payer dynamics as well. The same coverage policies that apply in newly diagnosed would need to incorporate this data, but I think it's an easier hurdle to cross than it is when you're starting with a new indication. Too soon to get specifics because the data will drive those discussions, but we're very hopeful and excited about this trial.

Jason Bedner (Managing Director and Senior Research Analyst)

All right. We'll wait on that then. Maybe if I could squeeze in one 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 2A versus 2B versus three ultimately influences commercial coverage?

Ashley Cordova (CEO)

Yeah, it's probably too soon to handicap other than to say anything is helpful, and the higher in the category ranking you could go, the more helpful, right? 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. I think that's important, that it's not kind of where you start is where you end. Certainly, publication volume matters here. We're as eager as everybody is to see those updated guidelines published later this fall.

Jason Bedner (Managing Director and Senior Research Analyst)

Perfect. Thank you.

Operator (participant)

Thank you. Now, next question coming from the line of Vijay Kumar with Evercore ISI. He'll let us know.

Vijay Kumar (Senior Managing Director)

Hey, guys. Thanks for taking my question. I had two from my side. One maybe on ASCO, PANOVA. Bill or Ashley, what was the reception at ASCO? If you could just elaborate on physician feedback and compare and contrast this with your prior podium presentations at ASCO.

Bill Doyle (Executive Chairman)

Maybe I'll start as the longest-serving member of the team here. Vijay, our very first presentation at ASCO, which was the EF-11 data, no one came to the presentation. EF-14 was very well attended, but there was little understanding about the mechanism of action and just a lot of questions about what is this new therapy. This was by far the most exciting ASCO that I've 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 discussant, and we mentioned this in the script, who was unfamiliar previously with Tumor Treating Fields therapy, Dana-Farber physician, concluded that our therapy should be standard of care. 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. We followed 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. That was reflected in what I'll call the talk on the floor. Maybe I'll turn it over to Frank and Ashley because we were all there, to reflect on some of that, I'll call the hubbub. This is highly anticipated at this point.

Ashley Cordova (CEO)

Yeah, I mean, 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. I would also say that that extended into the discussions. ASCO is one event. It's great to see that energy and excitement, but we really needed that to continue onto the ongoing physician dialogue. We've seen that. I was at ESMO GI in Barcelona last month when we were presenting the quality of life data. I will say, you know, 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.

Vijay Kumar (Senior Managing Director)

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

Christoph Brackmann (CFO)

Yeah. I would think of it as a recurring feature. As I said also in the script, we recognize revenue by applying estimated future collection rates. We do this by portfolio for our commercial portfolio, for Medicare, for Medicaid. We do this as best as we can. We would typically expect some revenue from prior periods, as disclosed in the 10-Q, in the range of somewhere between 3% to 5%. That's in line with Q2 of this year. Last year, there was a higher percentage, and hence we called it out.

Vijay Kumar (Senior Managing Director)

Understood. I guess on CMS, is CMS back pay part of this, or is it separate?

Christoph Brackmann (CFO)

Yeah, it's not really a key revenue driver of the prior period claims in this quarter.

Vijay Kumar (Senior Managing Director)

Understood. Thank you, guys.

Operator (participant)

Thank you. Our next question coming from the lineup, Jonathan Chang with Leerink Partners. He'll let us know.

Jonathan Chang (Senior Managing Director of Emerging Oncology)

Hi, guys. Thanks for taking my questions. First question, how should we be thinking about your path to profitability? How are you tracking relative to your plans? What are the key levers, and is there a timeframe that we should be modeling around? 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 four? Thank you.

Christoph Brackmann (CFO)

Yeah. Hi, Jonathan. It's Christoph. On our path to profitability, I would first say, look, it's very important for us to get to profitability. As we alluded to in the past, we have a path to profitability. We are obviously very conscious of balancing investments in our launches as well as in future innovations, 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.

I think that's still a good anchor to think about. I think we don't really want to give you a clear timeframe, but 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.

Jonathan Chang (Senior Managing Director of Emerging Oncology)

To the second question, and thank you for that one, allow me first to contextualize that PANOVA-3 was the first positive trial with OS. On top of that, the quality of life was positive as well as we saw it at ESMO. On top of it, the pain-free survival was very positive. That led to a huge discussion and interest by the investigators. Interestingly, when you combine TTFields to gemcitabine and nab-paclitaxel, your standard of care, you don't have added adverse event, which means it's highly combinationable, if I may say. We're actively discussing, actively looking into new combinations, and there are a few to come with a number of groups out there.

Ashley Cordova (CEO)

Jonathan, I'll just remind you that the next data set we'll have public with pancreatic cancer is our PANOVA-3 data, which comes out in the front half of next year. Company-sponsored, looking at gemcitabine, nab-paclitaxel, and metastatic things. We'll have that in hand, and I think that will also inform future directions.

Jonathan Chang (Senior Managing Director of Emerging Oncology)

Got it. Thanks for taking the questions.

Operator (participant)

Thank you. Next question coming from the lineup, Jessica Fye with J.P. Morgan. He'll let us know.

Jessica Fye (Managing Director of Equity Research Analyst)

Hey, guys. Good morning. Thanks for taking my questions. 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 2025 could conceivably come after the PANOVA PMA in the third quarter of 2025, given how much longer we've had the METIS data relative to PANOVA? The second one, 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 Lua sales this quarter, so like $2.8 million to $4.7 million, or should I apply that 3% to 5% range to some other revenue number? Thank you.

Ashley Cordova (CEO)

Jessica, this is Ashley. I'll try to answer both of those, and then if we have follow-up, I'll hand it off to Christoph. On the first, it's an easy answer. It's actually the form factor of the submission. I'll remind you that with METIS, we have a modular submission. 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, at 150 kilohertz, which is our lung cancer frequency. Those two modules need to get through at the FDA through to approval before we're able to submit module 3. 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.

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 be the clinical module. It's a fairly straightforward and easy answer. To the second, I would just remind everybody that this is not new. This disclosure, you can actually go and look at over the prior years, and I would like, we've always seen it in the line of this 3% to 5%. Anytime it bubbles up above that, we call it out on the script. I would say I wouldn't try to model this anywhere. This is well baked, and in our roadmap, it has been since the implementation of 606.

Operator (participant)

Thank you. Our next question coming from the lineup, Kevin DeGeeter with Ladenburg Thalmann. He'll let us know.

Kevin DeGeeter (Managing Director of Equity Research)

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

Ingrid Goldberg (VP of Finance and Investor Relations)

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 attribute it 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, we don't necessarily see a key link there. We have to fit into the guidelines as the NCCN has already published them. We're not trying to influence the way in which they present their guidelines.

That said, what we are doing and will begin to see, 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 of once you're post-platinum and you're thinking about what do I do at the first sign the patient's not doing well, go to Optune.

Kevin DeGeeter (Managing Director of Equity Research)

Great. Just as a follow-up, in your prior calls, you discussed the potential opportunity for U.S. commercial decisions on Optune Lua potentially in 2025 based on the, I guess, potential timing of NCCN guideline releases. Is that still the right way to think about the pace of dialogue with major U.S. payers, or is perhaps into 2026 a more realistic assessment?

Ashley Cordova (CEO)

Yeah, 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. We had $1.1 million in this quarter, and I think we would expect each quarter to add a few, you know, a sizable number to that target to get to where we would exit 2025 with not an immaterial, but not a significant amount of money from Optune Lua in the U.S. We think we're on track for that, and we would expect really the full driver of top-line growth appearing in 2026. Exiting with strength in 2025 and really seeing material top-line growth in 2026.

Kevin DeGeeter (Managing Director of Equity Research)

Thanks for taking the questions.

Operator (participant)

Thank you. Our final question comes from the line of Emily Bodnar with H.C. Wainwright. He'll let us know.

Emily Bodnar (VP of Equity Research)

Hi. Good morning. Thanks for taking the questions. Could you clarify if the $94 million in U.S. sales includes the $2.4 million from Optune Lua, or was that separate? 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 2025?

Ashley Cordova (CEO)

The 94 includes all of the revenue inclusive of the Optune Lua. That's both Optune Gio and Optune Lua. Yes, we do. The U.S. and Germany are the two markets that we have the opportunity to go and seek case-by-case reimbursement. It'll follow a similar trajectory in Germany as we're seeing it follow in the U.S.

Emily Bodnar (VP of Equity Research)

Got it. Okay. Makes sense. 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've had prior immune checkpoint inhibitors?

Ingrid Goldberg (VP of Finance and Investor Relations)

Hi, this is Frank. Thank you for the question. I would say, you know, we're not able to track to overall survival, so we can't comment on a hard clinical endpoint. 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. As I said, we're seeing physicians who have now had patients on from the launch quarter, so we're pretty far into it. They're expressing a strong confidence in building a practice with more and more patients on the therapy.

Emily Bodnar (VP of Equity Research)

Okay. Great. Thank you.

Operator (participant)

Thank you. There are no further questions. Thank you. I will now turn the call back over to Mr. Bill Doyle for any closing remarks.

Bill Doyle (Executive Chairman)

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

Operator (participant)

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