NovoCure Limited

Good day and thank you for standing by. Welcome to the NovaCure Q1 2024 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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Ingrid Goldberg.

Good morning, and thank you for joining us to review Novocare's first quarter 2024 performance. I'm joined this morning by our Executive Chairman, Bill Doyle, our CEO, Asaf Donziger, and our CFO, Ashley Cordova. 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.investorcare.com, and on our 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 for 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 8-K, 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 Novacure, our mission is to extend survival in some of the most aggressive forms of cancer, by developing and commercializing our innovative therapy tumor treating fields. Over the last two decades, we've established TT Field's mechanism of action, developed and improved the TT Field's delivery technology, completed multiple successful phase three clinical trials, treated over 30,000 commercial patients, and built an innovative business model. We entered 2024 ready to build on this foundation and I'm pleased to report our progress today. In March, we announced that our METIS Phase III clinical trial, studying the benefits of treating brain metastases from non-small cell lung cancer with TT field therapy, met its primary endpoint, providing a statistically significant extension in time to intracranial progression. Later this year, we expect FDA, PMA, and EU CE mark approvals for TT Fields therapy in metastatic non-small cell lung cancer post-platinum progression, and an FDA PMA supplement approval for our next generation arrays for GBM. Toward the end of 2024, we will announce top-line data from our Phase III trial in locally advanced pancreatic cancer. 2024 is an exciting year for Novocare with many milestones. I am incredibly grateful for the hard work of our colleagues and for the dedication of our patients and prescribing physicians. On today's call, we will begin with a review of our commercial business in GBM. We will then discuss clinical trial updates from the quarter, and we will close with a discussion of our Q1 financial results before opening the line for questions. In the first quarter at Novacure, we continued our steady pace of execution. We finished Q1 with 1,643 new prescriptions and 3,845 active patients on therapy. Both are global records for our organization. Our global commercial team is focused on all levers of active patient growth, including prescriptions, patient starts, and long-term compliance and persistence. We believe each input is critical to achieving the best outcomes for patients, which in turn we believe will drive sustainable growth. We also believe product development enhancements can drive improved patient outcomes. As a reminder, last year we successfully introduced our next generation arrays in several European countries, and our PMA supplement for the new arrays was filed with the FDA in December. The new arrays are lighter, thinner, more flexible, and leverage new materials to improve the patient experience. New patents have been filed in our key markets to protect the improved design. In the US, our teams are focused on increasing awareness of the benefits of TT Field's therapy among potential patients and prescribing physicians. Last month, we launched a direct-to-consumer campaign, I Power My Life. Our new print and digital assets and our first-ever direct-to-consumer television advertising campaign are key to our efforts to grow our GVM business. Through connected television, which reaches most U.S. households, we are educating potential patients and caregivers about OpTune Geo. We believe direct-to-patient messaging will raise awareness of TT Field's therapy and strengthen the demand from patients following diagnosis.