NovoCure Q2 2025 Earnings Report

NovoCure EPS Results

• Actual EPS: -$0.36
• Consensus EPS: -$0.39
• Beat/Miss: Beat by +$0.03
• One Year Ago EPS: -$0.31

NovoCure Revenue Results

• Actual Revenue: $158.80 million
• Expected Revenue: $153.87 million
• Beat/Miss: Beat by +$4.93 million
• YoY Revenue Growth: +5.60%

NovoCure Announcement Details

• Quarter: Q2 2025
• Date: 7/24/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, July 24, 2025
• Conference Call Time: 8:00AM ET

NovoCure (NASDAQ:NVCR), an oncology company, engages in the development, manufacture, and commercialization of tumor treating fields (TTFields) devices for the treatment of solid tumor cancers in the United States, Germany, Japan, Greater China, and internationally. The company's TTFields devices include Optune Gio and Optune Lua. It also has ongoing clinical trials investigating TTFields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer, and ovarian cancer. NovoCure Limited was incorporated in 2000 and is headquartered in Saint Helier, Jersey.

NovoCure Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Novocure’s PANOVA-3 trial in unresectable pancreatic cancer showed a median overall survival of 16.2 months versus 14.2 months in the control arm and extended pain-free survival, with an FDA PMA filing expected in Q3 2025.
• Positive Sentiment: The METIS study in brain metastases from non-small cell lung cancer demonstrated a 28% risk reduction in time to intracranial progression (15.0 vs 7.5 months; p=0.044), with modular FDA PMA submissions underway and approval anticipated in 2026.
• Positive Sentiment: Optune™Lua launched for non-small cell lung cancer in the US and Germany, delivering 121 prescriptions in Q2 and $2.4 million in net revenue as Novocure builds prescriber adoption and pursues reimbursement expansions.
• Positive Sentiment: The GBM franchise reached 4,194 active patients (up 7% year-over-year) and real-world data from Mayo Clinic showed a two-year survival rate of 58% with Tumor Treating Fields versus 41% without.
• Neutral Sentiment: Q2 net revenues rose 6% to $159 million, while a $40 million GAAP loss and negative $10 million adjusted EBITDA reflect continued investment; cash reserves of $912 million support the path to adjusted EBITDA profitability around $750 million in revenue.

Presentation

[Operator]

Good day. Thank you for standing by. Welcome to Novocure's Second Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session.

[Operator]

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 - Finance & IR at NovoCure]

Good morning, and thank you for joining us to review Novocure's second quarter twenty twenty five performance. I'm on the phone this morning with our Executive Chairman, Bill Doyle CEO, Ashley Cordova and CFO, Christophe Brockman. Other members of our executive leadership team will be available for Q and A. For your reference, slides accompanying this earnings release can be found on our website, www.novocare.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.

[Ingrid Goldberg, VP - Finance & IR at NovoCure]

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.

[Ingrid Goldberg, VP - Finance & IR at NovoCure]

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.

[William Doyle, Executive Chairman & Director at NovoCure]

Thank you, Ingrid, and good morning.

[William Doyle, Executive Chairman & Director at NovoCure]

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 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-three data presentations at two key medical conferences, and we will review the next steps for our upcoming regulatory submissions of Panova-three 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 and A.

[William Doyle, Executive Chairman & Director at NovoCure]

While our commercial teams pursue greater penetration in improved indications, we are working intensely to gain approvals in new indications. This quarter, we took important steps towards approval in pancreatic cancer. The five year survival rate for patients diagnosed with pancreatic cancer is only thirteen percent, 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-three trial proved the benefit of PT Fields therapy together with gemcitabine and nab paclitaxel for both of these endpoints.

[William Doyle, Executive Chairman & Director at NovoCure]

In May, we had an exciting presence at the ASCO annual meeting where data from PANOVA-three were presented during the Saturday evening pancreatic cancer plenary session. The PANOVA-three findings were concurrently published in the Journal of Clinical Oncology, or JACO, and earned inclusion in Best of ASCO, which will be highlighted at regional ASCO meetings throughout the year. As a reminder, the PANOVA-three intent to treat population in unresectable locally advanced pancreatic cancer patients treated with TT fields together with gemcitabine and nab paclitaxel saw a median overall survival of sixteen point two 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. PT Fields patients also saw a benefit in pain free survival, with a median time to increased pain in the intent to treat group of fifteen point two months versus nine point one months in the control group.

[William Doyle, Executive Chairman & Director at NovoCure]

Following the presentation, session discussant Doctor. Brian Wilpalm of Dana Farber, who played the role of objective reviewer, said TTFields plus gemcitabine and nampapaclataxil would be an appropriate option for standard of care. Doctor. Eileen O'Reilly of Memorial Sloan Kettering Cancer Center commented in the JACO 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 TT Fields therapy.

[William Doyle, Executive Chairman & Director at NovoCure]

The Panova-three results earned a second late breaking podium presentation at the ESMO GI Annual Congress, where the quality of life data from Panova-three was described in greater detail. Patients treated with TT fields in gemcitabine and nav 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-three showed TTField's 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 TP Fields 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.

[William Doyle, Executive Chairman & Director at NovoCure]

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.

[William Doyle, Executive Chairman & Director at NovoCure]

The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in the time to intracranial progression for patients treated with TT field 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 TT Fields therapy and supportive care exhibited a risk reduction of twenty eight percent, with median time to intracranial progression of fifteen months compared to seven point five 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.

[William Doyle, Executive Chairman & Director at NovoCure]

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 PONOVA-three and METIS PMA filings, we expect a nine- to twelve 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.

[William Doyle, Executive Chairman & Director at NovoCure]

The Phase III TRIDENT trial in newly diagnosed GBM studies the potential benefits of initiating TT Fields therapy several months earlier in the patient's journey concurrent with chemoradiation rather than after chemoradiation. PANOVA-four 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.

[Ashley Cordova, CEO at NovoCure]

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 OptuneLua 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.

[Ashley Cordova, CEO at NovoCure]

S. And 15 in Germany, which launched following receipt of the CE Mark on April 22. We ended the period with one hundred and thirty seven Optune MUA patients globally, ninety four from non small cell lung cancer and forty three from NPM. Importantly, we are beginning to build reimbursement experience and recognized $2,400,000 in net revenues from OptuneLua in the quarter, of which $1,100,000 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.

[Ashley Cordova, CEO at NovoCure]

S. In Q2, we had 75 unique prescribers of OptuneLua. Forty one of those physicians were entirely new to Tumor Treating Fields therapy, while thirty four 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 fifty eight percent of prescriptions written together with immune checkpoint inhibitors and forty two percent with docetaxel.

[Ashley Cordova, CEO at NovoCure]

Importantly, over ninety three percent of the patients prescribed Optomua 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 first hand prescribing Optune G O NGVM or Optune LUA for NPM, or through access to a colleague with tumor treating field 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 Geo experience.

[Ashley Cordova, CEO at NovoCure]

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 Optamua 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 OPTAMOUA 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.

[Ashley Cordova, CEO at NovoCure]

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 US. 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 US. Japan is the next market where we expect to launch Optumlua for non small cell lung cancer.

[Ashley Cordova, CEO at NovoCure]

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.

[Ashley Cordova, CEO at NovoCure]

We have had some early success in case by case reimbursement submissions, with over $1,000,000 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.

[Ashley Cordova, CEO at NovoCure]

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 twelve months. Turning to our GBM business, we continued to march higher and finished the quarter with 4,194 Optune GEO patients on therapy, a 7% increase compared to last year. Each of our key markets, The US, Germany, France, and Japan, increased their patient count year over year, with all our ex US markets experiencing double digit growth.

[Ashley Cordova, CEO at NovoCure]

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 three seventy four GBM patients treated at Mayo Clinic locations between 2014 and 2023.

[Ashley Cordova, CEO at NovoCure]

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 fifty eight percent compared to just forty one percent in patients not treated with Tumor Treating Fields. The Mayo study is another example of confirmatory data and reaffirms why Optune Geo 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 would like to express my gratitude to the Novocure team for their hard work during this important year.

[Ashley Cordova, CEO at NovoCure]

The fundamentals of our business continue to strengthen each quarter. Q2 marks the eleventh consecutive quarter of active patient growth. During that time, we've had three positive phase three 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.

[Ashley Cordova, CEO at NovoCure]

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 at NovoCure]

Thank you, Ashley. We continued our positive momentum this quarter with net revenues of $159,000,000 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 $3,800,000 in the quarter, offset by lower one time benefits of prior period claims. We collected $2,400,000 from OptuneLure claims in the quarter, including $1,100,000 from non small cell lung cancer collections in the period compared to $1,500,000 and 700,000 in Q1.

[Christoph Brackmann, CFO at NovoCure]

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.

[Christoph Brackmann, CFO at NovoCure]

Gross margin for the second quarter was 74% compared to 77% in Q2 of twenty twenty four. This reduction was primarily driven by the rollout of our HIV 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 costs of the HFE arrays and establish reimbursement in non small cell lung cancer. We only had a minor impact from tariffs in the quarter of $1,300,000 driven by a reduction in pre tariff inventory in Q2. While there is still considerable uncertainty around future tariffs for import into The U.

[Christoph Brackmann, CFO at NovoCure]

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 P and L impact is up to approximately 7,000,000 subject to timing, rates, and exemptions from these tariffs.

[Christoph Brackmann, CFO at NovoCure]

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 $56,000,000 an increase of 2% from the second quarter of twenty twenty four. We do not expect R and 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 $57,000,000 an increase of 1% from Q2 of last year.

[Christoph Brackmann, CFO at NovoCure]

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.

[Christoph Brackmann, CFO at NovoCure]

G and A expenses for the quarter were $44,000,000 an increase of 17% from the second quarter of twenty twenty four. 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 $40,000,000 with a loss per share of $0.36 Adjusted EBITDA in the quarter was negative $10,000,000 Our cash and investment balance at the end of Q2 was $912,000,000 We have $560,000,000 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 $100,000,000 each from our credit facility, which will close on 09/26/2025. According to the terms of our credit facility, we have an obligation to draw the first two tranches.

[Christoph Brackmann, CFO at NovoCure]

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 eleventh 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.

[Christoph Brackmann, CFO at NovoCure]

I will now turn the call back to the operator for questions.

[Operator]

Thank you. Our first question coming from the line of Larry Biegelsen with Wells Fargo. Your line is now open.

[Lawrence Biegelsen, Senior Medical Device Equity Research Analyst at Wells Fargo]

Good morning. Thanks for taking the question. So 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.

[Lawrence Biegelsen, Senior Medical Device Equity Research Analyst at Wells Fargo]

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 5,000,000 to $10,000,000 range that's been discussed before for 2025? And I had one follow-up.

[Ashley Cordova, CEO at NovoCure]

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

[Ashley Cordova, CEO at NovoCure]

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.

[Frank Leonard, EVP & President - Novocure Oncology at NovoCure]

Yeah, 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 and 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.

[Lawrence Biegelsen, Senior Medical Device Equity Research Analyst at Wells Fargo]

That's helpful. One follow-up on the MEDIS 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.

[William Doyle, Executive Chairman & Director at NovoCure]

Sure. So let me just remind everybody of what the MEDIS trial was studying. So in non small cell lung cancer, brain metastases are one of the really significant markers of deterioration in the patients. About twenty five percent of patients are actually diagnosed with brain mets when they're diagnosed with cancer and at least another twenty five percent. So this is a significant unmet need in non small cell lung cancer, and in fact, the standard of care is stereotactic radiosurgery followed by supportive care.

[William Doyle, Executive Chairman & Director at NovoCure]

So in METIS, we studied the addition of tumor treating fields to supportive care after stereotactic radius surgery, and the endpoint of this study was progression. All of our other trials, the endpoints are overall survival, where the endpoint is, you know, specific and very binary. In this case, and this is very 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. You know, we're of course delighted that the data considered continued to be very statistically significant and very clinically meaningful.

[Lawrence Biegelsen, Senior Medical Device Equity Research Analyst at Wells Fargo]

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

[Operator]

Thank you. And our next question coming from the line of Jason Bednar with Piper Sandler. Your line is now open.

[Jason Bednar, MD & Senior Research Analyst at Piper Sandler Companies]

Hi, 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 medtech 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 US and Germany as well.

[Frank Leonard, EVP & President - Novocure Oncology at NovoCure]

Yeah 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 four non small cell lung cancer. The physicians are not satisfied 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 ninety percent of our patients had been previously treated with immune checkpoint inhibitors.

[Frank Leonard, EVP & President - Novocure Oncology at NovoCure]

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.

[Frank Leonard, EVP & President - Novocure Oncology at NovoCure]

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. And so we're going to lean into that. And we think we have the opportunity to grow faster.

[Jason Bednar, MD & Senior Research Analyst at Piper Sandler Companies]

All right. Helpful. Thanks, Frank. And then one other one, looking ahead to Trident. This is a bit of a different trial.

[Jason Bednar, MD & Senior Research Analyst at Piper Sandler Companies]

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 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 at NovoCure]

Thanks for the question, Jason. This is Ashley. I'll say, 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 and 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.

[Ashley Cordova, CEO at NovoCure]

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 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 the 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 Bednar, MD & Senior Research Analyst at Piper Sandler Companies]

Okay, all right. We'll wait on that then. And then maybe if I could squeeze in one more just on the NCCN guidelines. I don't 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 at NovoCure]

Yeah, it's probably too soon to handicap other than to say you know, anything is helpful and the higher in the category ranking you could go, the more helpful. So, I would think anything, you know, even being on the guidelines in any calculation is a step up from where we are today. With 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, volume matters here and we're as eager as everybody is to see those updated guidelines published later this fall.

[Jason Bednar, MD & Senior Research Analyst at Piper Sandler Companies]

Perfect, thank you.

[Operator]

Thank you. And our next question coming from the line of Vijay Kumar with Evercore ISI. Your line is now open.

[Vijay Kumar, Senior MD at Evercore ISI]

Hey, guys. Thanks for taking my question. I had two from my side. One maybe on ASCO, Panova. Bill or Ashley, was the reception at ASCO?

[Vijay Kumar, Senior MD at Evercore ISI]

If you could just elaborate on physician feedback and compare contrast this with your prior podium presentations at ASCO.

[William Doyle, Executive Chairman & Director at NovoCure]

Maybe I'll start as the longest serving member of the team here. Vijay, our very first presentation at ASCO, which was the EF11 data, no one came to the presentation. EF14, you know, was very well attended, but there was little understanding about the mechanism of action and, you know, just a lot of questions about, you know, what is this new therapy? This was by far the most exciting ASCO that I've attended in twenty five years. We were front and center on the podium in the plenary session.

[William Doyle, Executive Chairman & Director at NovoCure]

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 and ours was the only presentation for which that conclusion was delivered. The others were more study of this, study of that. The side effects don't seem to justify the benefit. And then 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.

[William Doyle, Executive Chairman & Director at NovoCure]

And that was reflected in, you know, the, what I'll call the, you know, the talk on the floor. And maybe I'll turn it over to Frank and Ashley because we were all there, but to reflect on some of that, I'll call the, you know, the hubbub, but this is highly anticipated at this point.

[Ashley Cordova, CEO at NovoCure]

Yeah, mean the 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 one 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.

[Vijay Kumar, Senior MD at Evercore ISI]

That's helpful. Then maybe one for Christophe. On revenues here, I think your 10 Q had some details on revenues recognized from performance obligations for prior period service rendered. I know, you know, there is a CMS backlog, you know, payments one offs which comes in from time to time. What was CMS back pay?

[Vijay Kumar, Senior MD at Evercore ISI]

Is that included as part of this performance obligation or how should we think about this CMS versus the non CMS? Is is this more of a recurring feature, or should we think of it as a one off? Thank you.

[Christoph Brackmann, CFO at NovoCure]

Yeah. So I would think of it as a recurring feature. You know, as I said also in the script, we recognize 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 three to five 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.

[Vijay Kumar, Senior MD at Evercore ISI]

Understood. And so you're saying CMS. Is CMS backlit part of this, or is that separate?

[Christoph Brackmann, CFO at NovoCure]

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

[Vijay Kumar, Senior MD at Evercore ISI]

Understood. Thank you, guys.

[Operator]

Thank you. Our next question coming from the line of Jonathan Chang with Leerink Partners. Your line is now open.

[Jonathan Chang, Senior MD & Senior Research Analyst at Leerink Partners]

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? And what are the key levers?

[Jonathan Chang, Senior MD & Senior Research Analyst at Leerink Partners]

And is there a timeframe that we should be modeling around? And then second question on the pancreatic cancer opportunity. Are there plans to pursue combinations with other chemo regimens beyond what's being evaluated in Panova three and four? Thank you.

[Christoph Brackmann, CFO at NovoCure]

Yeah. Hi, Jonathan. It's Christophe. So on our path to profitability, I would first say, look, It's very important for us to to get to profitability. And as we alluded to in the past, we have a path to profitability.

[Christoph Brackmann, CFO at NovoCure]

We are obviously very conscious of balancing investments in our launches as well as in future innovation, so basically r and d, with our intent to become profitable. In the past, you know, we gave some color around that, you know, at a revenue level of around $750,000,000 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, you know, we don't really want to give you a clear timeframe, but I think with the revenue growth that you have seen in the past, that will probably give you some indications of when we think that's going to happen. I would say, to your question of where are we relative to our expectations, we are in line with our expectations.

[Christoph Brackmann, CFO at NovoCure]

To the second question, and thank you for that one, allow me first to contextualize that ONOVA3 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 GDFLD to GNP, a standard 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.

[Ashley Cordova, CEO at NovoCure]

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

[Jonathan Chang, Senior MD & Senior Research Analyst at Leerink Partners]

Got it. Thanks for taking the questions.

[Operator]

Thank you. And our next question coming from the line of Jessica Fye with JPMorgan. Your line is now open.

[Jessica Fye, MD & Equity Research Analyst - Biotechnology at JP Morgan]

Hey, guys. Good morning. Thanks for taking the 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 twenty five, could conceivably come after the Panova PMA in the third quarter of twenty five, 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 three to 5% of revenue. Do we apply that to the $94,000,000 of U. S.

[Jessica Fye, MD & Equity Research Analyst - Biotechnology at JP Morgan]

Optune sales this quarter, so, like, 2.8 to 4.7? Or should I apply that three to 5% range to some other revenue number? Thank you.

[Ashley Cordova, CEO at NovoCure]

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 Christophe. But the first is an easy answer. It's actually the form factor of the submission.

[Ashley Cordova, CEO at NovoCure]

So, I'll remind you that with MEDIS, we have a modular submission. So, Modules one and two went in April 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 one and which 50 is our lung cancer frequency. So, two modules need to get through at the FDA through to approval before we're able to submit module three.

[Ashley Cordova, CEO at NovoCure]

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 one and two getting through the review process, and then that final module will just be the clinical module. So, it's a very straightforward and easy answer. To the second, I would just remind everybody that this is not new.

[Ashley Cordova, CEO at NovoCure]

So, this disclosure, you can actually go and look at over the prior years. We've always seen it in the line of this three to 5% and anytime it bubbles up above that, we call it out on the script. So, would say I wouldn't try to model this anymore. This is well baked and in our run rate it has been since the implementation of 06/2006.

[Operator]

Thank you. Thank you. Our next question coming from the line of Kevin Dejeda with Ladenburg Thalmann. Your line is now open.

[Kevin DeGeeter, MD - Equity Research at Ladenburg Thalmann & Co. Inc]

Hey, great. Thanks for taking my questions this morning. I want to follow-up on Optulo, 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? 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? No, Bob.

[Frank Leonard, EVP & President - Novocure Oncology at NovoCure]

Well, I'll start just on the to start at the end with the payer note. 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. So we're not trying to influence the way in which they present their guidelines.

[Frank Leonard, EVP & President - Novocure Oncology at NovoCure]

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 of once you're post platinum and you're thinking about what do I do at the first time the patient's not doing well, go to Optune.

[Kevin DeGeeter, MD - Equity Research at Ladenburg Thalmann & Co. Inc]

Great. Then just as a follow-up, in prior calls, you've discussed the potential opportunity for U. S. Commercial decisions on Optune Blue 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 US payers or perhaps into 2026 a more realistic assessment?

[Ashley Cordova, CEO at NovoCure]

Yeah, Kevin, mean, 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, had 1,100,000 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 an immaterial but not a significant amount of money from Optimum in The US. We think we're on track for that and we would expect really the full driver of top line growth appearing in 2026. So, with strength in 2025 and releasing material top line growth in 2026.

[Kevin DeGeeter, MD - Equity Research at Ladenburg Thalmann & Co. Inc]

Thanks for taking my questions.

[Operator]

Thank you. And our final question comes from the line of Emily Buzznar with H. C. Wainwright. Your line is now open.

[Emily Bodnar, Biotech Equity Research Analyst at H.C. Wainwright & Co.]

Hi, good morning. Thanks for taking the questions. Could you clarify if the $94,000,000 in U. S. Sales includes the $2,400,000 from Optinlua or was that separate?

[Emily Bodnar, Biotech Equity Research Analyst at H.C. Wainwright & Co.]

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 twenty twenty five?

[Ashley Cordova, CEO at NovoCure]

So, Emily, the 94 includes all of the revenue inclusive of the Optune LEO, so that's both Optune GO and Optune LEO. And yes, we do. I mean, The US and Germany are the two markets that we have the opportunity to go and seek case by case reimbursement, so it'll follow a similar trajectory in Germany as we're seeing it follow in The US.

[Emily Bodnar, Biotech Equity Research Analyst at H.C. Wainwright & Co.]

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've had prior immune checkpoint inhibitors?

[Frank Leonard, EVP & President - Novocure Oncology at NovoCure]

Hi, 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 endpoint 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 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.

[Emily Bodnar, Biotech Equity Research Analyst at H.C. Wainwright & Co.]

Okay, great. Thank you.

[Operator]

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

[William Doyle, Executive Chairman & Director at NovoCure]

Well, thank you. As we've underlined, during the last few quarterly calls, this is a very exciting time at Novocure. We are moving from a single indication company treating patients with GBM to a multi indication international cancer therapy company. We've made tremendous progress this year so far, all first on the foundation of a very strong and stable business in GBM, and one where, as Ashley and Christophe noted, we now have hit the eleventh successive quarter of active patient growth. And from there, we're in the early days, but exciting days of our OptuneLua launch in non small cell lung cancer, and we are furiously busy at the FDA with both our METIS and our PANOVA3 filings with the potential for launches next year in pancreatic cancer and in brain mets from non small cell lung cancer.

[William Doyle, Executive Chairman & Director at NovoCure]

We're busy. It's exciting, and we look forward to keeping you up to date in future calls.

[Operator]

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

Participants

Executives

• Ingrid Goldberg, VP - Finance & IR
• William Doyle, Executive Chairman & Director
• Ashley Cordova, CEO
• Christoph Brackmann, CFO
• Frank Leonard, EVP & President - Novocure Oncology

Analysts

• Lawrence Biegelsen, Senior Medical Device Equity Research Analyst at Wells Fargo
• Jason Bednar, MD & Senior Research Analyst at Piper Sandler Companies
• Vijay Kumar, Senior MD at Evercore ISI
• Jonathan Chang, Senior MD & Senior Research Analyst at Leerink Partners
• Jessica Fye, MD & Equity Research Analyst - Biotechnology at JP Morgan
• Kevin DeGeeter, MD - Equity Research at Ladenburg Thalmann & Co. Inc
• Emily Bodnar, Biotech Equity Research Analyst at H.C. Wainwright & Co.