NovoCure Limited

Time all participants on the 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 1-1 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.

Good morning, and thank you for joining us to review Novocare's second quarter 2025 performance. I am 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.novicure.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-gap-to-gap 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 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 MEDIS. 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 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 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 PT field therapy together with gemcitabine and nabpaclitaxel 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 populations In unresectable, locally advanced pancreatic cancer patients treated with TT fields together with gemcitabine and nabpaclitaxel 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. T.T. Fields' 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 Wilpom of Dana-Farber, who played the role of objective reviewer, said T.T. Fields plus gemcitabine and nampaplitaxel would be an appropriate option for standard of care. Dr. Eileen O'Reilly of Memorial Sloan Kettering Cancer Center commented in the Jayco editorial that tumor-treating fields together with gemcitabine and nabpaclitaxel 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. 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 TT Fields and gemcitabine and nabpaclitaxel 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 TT Field'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 TT Field's therapy for these patients. And given the extremely limited options for pancreatic cancer patients, the feedback from physicians KOLs, and advocacy groups following these presentations has been overwhelmingly positive. Our teams are working on the FDA PMA submission for pancreatic cancer. Earlier this month, we met with the FDA for a pre-submission discussion in anticipation of submitting our full PMA package for FDA review. We expect to file the PMA with the FDA in the third quarter. Concurrently, We are working on the regulatory packages for Europe and Japan and expect to file these prior to year-end. Brain metastases from non-small cell lung cancer is our next potential indication. The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in the time to intracranial progression for patients treated with TT fields 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 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 PNOVA III and MEDIS PMA filings, we expect a nine 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 TT Fields therapy several months earlier in the patient's journey, concurrent with chemoradiation rather than after chemoradiation. Penova IV is a Phase II trial that adds the immunotherapy atezolizumab to TT Fields, gemcitabine, and nabpaclitaxel 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.