NovoCure Limited

Good day, and thank you for standing by. Welcome to the NovoCure third quarter 2025 earnings call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised, today's conference is being recorded. I would now like to hand the conference over to your speaker today. Ingrid Goldberg, please go ahead.

Good morning. And thank you for joining us to review Novocare's third quarter 2025 performance. I'm on the phone this morning with our executive chairman, Bill Doyle, CEO, Ashley Cordova, and CFO, Christoph Brockman. 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.novacare.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 the non-GAAP financial measures to evaluate our business, specifically adjusted EBITDA, a measure of earnings before interest, taxes, depreciation, amortization, and share-based compensation. We believe adjusted EBITDA is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material non-cash items, and best reflects the financial value generated by our business. Reconciliations of non-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.

Thank you, Ingrid, and good morning. At NovoCure, our mission is to extend survival in some of the most aggressive forms of cancer. Through our early years, our efforts focused mostly on the treatment of patients with glioblastoma. Now, with one launch ongoing and two additional launches planned for next year, the scope of our mission has expanded. to reach more patients who can benefit from tumor treating fields in multiple solid tumor cancers. As we evolve from a single indication company to a true platform therapy company, we are focused on three priorities. First, preparing to treat four cancer indications by year end 2026. Second, reaching profitability. And third, making disciplined investments that strengthen our product portfolio in the near and the long term. We will begin this morning with a review of our Q3 commercial results in glioblastoma and non-small cell lung cancer. We will discuss regulatory updates and preparation for anticipated launches in pancreatic cancer and brain metastases. we will provide updates to our ongoing clinical and product development programs. We will conclude with a review of our quarterly financials and open the line for questions. Our GVM business remains solid, and active patients have grown between 5% and 12% year over year for the last nine consecutive quarters. We ended the third quarter with 4,277 GBM patients on therapy, our largest patient count to date. The largest contributors to active patient growth in this quarter were France, Japan, and Germany, which grew 27%, 8%, and 7% respectively. We also expanded our international footprint. Last month, we received a positive national coverage decision from the Spanish Ministry of Health. At maturity, we expect Spain to deliver annual net revenue that is approximately half that of France. We expect full ramp up to take a few years given the fragmented nature of the Spanish healthcare system. In the US, our GBM active patient count was flat compared to Q3, 2024. While we are proud to be treating approximately 40% of GBM patients in the U.S., we recognize that many more patients could benefit from TT field therapy. Unlike lung cancer and pancreatic cancer, where most patients seek treatment in community centers, virtually all GBM patients undergo brain surgery at high-volume academic centers after diagnosis. Oncologists at academic centers often prioritize enrollment in pharmaceutical clinical trials over new medical device-based therapies. This dynamic limits the number of patients offered Optune Geo in academic centers despite the established clinical benefits of TT Fields therapy. Our commercial team continues to refine its approach within this complex environment, and we remain committed to ensuring that all eligible GBM patients are offered Optune geotherapy. Turning to non-small cell lung cancer. We've acknowledged that our launch is behind expectations. And in Q3, we did not see a continuation of the linear growth we've seen in the prior two quarters. While we anticipated lung cancer would be our most challenging indication to launch, it has been harder than we expected. We finished Q3 with 100 lung cancer patients on therapy, 94 in the U.S., and six in Germany. What makes advanced lung cancer particularly challenging is the poor overall health status of these patients, the high level of competition from new targeted drug therapies, and the limited median duration of therapy, four months versus the 10 months for newly diagnosed GBMs. We experienced similar launch challenges in 2011 with our initial launch in recurrent GBM when we introduced our device-based therapy to the neuro-oncology community in an advanced cancer setting. With GBM, we learned that consistent education and follow-on data generation drives prescriber and patient adoption over time. We are anticipating a similar path in lung. To delve deeper, Lung cancer is a highly competitive space. The survival benefit demonstrated in the lunar phase three trial remains among the best reported in the post-platinum setting. But the number of systemic drug therapies available across settings makes the transition to a novel device-based modality like OptumLua seem like a heavier lift for both physicians and patients. Our sales team is tackling this by highlighting specific patient profiles to help physicians better understand where OptumLua is likely to provide the best benefit. Our primary focus is on patients who have had a durable response to a checkpoint inhibitor plus a platinum doublet and have slow progression with a maintenance checkpoint inhibitor. There is also the challenge of introducing a device-based therapy to a medical oncology community that has limited device experience. As mentioned, we face a similar hurdle when we introduced OptuneGIA to recurrent GBM. And we know it takes time and hands-on experience for physicians to gain comfort with a device-based therapy. Simply put, a wearable device is novel in the oncology space. And as such, we are connecting experienced OptuneGIA and Lewy users who can share expertise and tips based upon real-world use with physicians new to the therapy to simplify the integration of OptumLua into their practices. Looking to the near-term future, an important upcoming milestone for OptumLua is our Japan launch. Last month, we received approval from Japanese regulators for the use of OptumLua and checkpoint inhibitors in advanced or recurrent non-small cell lung cancer. Japan has been a consistently strong region for NovoCure, and we are planning for strong physician adoption of OptumLua. We believe a high prevalence of lung cancer, Japanese physicians' appreciation for device-based therapies, and a local standard of care which frequently utilizes immune checkpoint inhibitors in the first and second lines provides the conditions for a successful launch in Japan. We will be closely monitoring the dynamics of our Japan launch to inform future strategies. Longer term, we are working on two core programs to reach more non-small cell lung cancer patients, Lunar 2 and product development. LUNAR-2 is our Phase III trial studying the use of Optune LUA plus checkpoint inhibitors and platinum-based chemo as a first-line treatment for newly diagnosed non-small cell lung cancer. Assuming success, LUNAR-2 will allow us to treat first-line lung cancer patients with Optune LUA and a checkpoint inhibitor, the drug-device combination demonstrating the best efficacy across indications. Our product development efforts are focused on making the Optune device easier for patients to use through near-term improvements in support services, software, and array design, and longer-term efforts to design a transformative next-generation device. It is critical to underline we believe our efforts in lung are worth it. The investments we are making for the lung cancer indication also paved the way for our anticipated launches in pancreatic cancer and brain metastases in the next 12 months. In summary, our core GBM business continues to grow, reaching more patients in more regions. Our lung cancer launch has been more difficult than anticipated, and we are learning and adapting our tactics. We have two additional launches in cancer indications with extremely high unmet needs anticipated in 2026 where minimal therapeutic options are currently available and that we can access with limited incremental investment as our lung cancer and GBM infrastructures will be leveraged. We are confident in our strategic direction, the strength of the clinical data, supporting the use of TT Fields Therapy and our plans to achieve profitability. With that, I'll turn to Ashley to provide an update on our regulatory and clinical progress.