NovoCure Limited

Good day, and thank you for standing by. Welcome to the NovoCure Q1 2023 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 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 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. Please go ahead.

Good morning, everyone. Thank you for joining us to review Novocear's first quarter 2023 performance. I'm on the phone this morning with our Executive Chairman, Bill Doyle, our CEO, Asaf Danziger, and our CFO, Ashley Cordova. Other members of our executive leadership team are also on the call and available for Q&A. For your reference, slides accompanying the earnings release can be found on our website, www.novacure.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 attributed 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 our Form 8K filed with the SEC today. These materials can also be accessed in the Investor Relations page of our website. Following our prepared remarks today, we 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 the lives of patients diagnosed with aggressive forms of cancer. Over the last two decades, we have completed multiple successful clinical trials, expanded our international footprint to include 10 global markets, published over 500 manuscripts, built a strong and sustainable business model, and most importantly, treated over 27,000 commercial patients. and the people we have helped. Next month at the American Society of Clinical Oncology annual meeting in Chicago, we will present the results of our phase three pivotal lunar trial in non-small cell lung cancer. Our ASCO presentation will mark the beginning of Novacure's next chapter with the intention to help tens of thousands of additional patients diagnosed with deadly cancers in the coming years. I am grateful for the hard work of Novacure's employees, as well as for the dedication and courage of our patients and prescribing physicians. I cannot wait for all that lies ahead in 2023. On today's call, we will begin with a discussion of our clinical catalyst, followed by a review of our core business in GBM. We will close today's call with a discussion of our first quarter financial results before opening the line for questions. Earlier this year, we announced the top line results of the phase three pivotal LUNR clinical trial, evaluating TT fields together with standard of care therapies in stage four non-small cell lung cancer. LUNR met its primary endpoint, providing the first advance in stage four refractory non-small cell lung cancer in more than seven years. LUNR demonstrated a profound benefit when TT field therapy was combined with immunotherapy, meeting a powered secondary endpoint, evaluating overall survival of patients treated with TT fields and a checkpoint inhibitor versus a checkpoint inhibitor alone. Lunar also demonstrated a positive trend in overall survival for patients treated with TT fields and docetaxel versus docetaxel alone. We are pleased to share that the Lunar data will be presented next month at the ASCO Annual Meeting in Chicago. On Tuesday, June 6th, lead investigator Dr. Titiana Leal of Emory University will present the lunar trial findings during the metastatic non-small cell lung cancer session. Later on Tuesday, NovoCure will host a presentation and question and answer session with Dr. Leal, fellow lunar investigator Dr. Corey Langer of the University of Pennsylvania, and NovoCure leadership. I will remind you the improvements in overall survival demonstrated by LUNR follow a period with no clinical improvement in the treatment of non-small cell lung cancer following platinum failure since 2016. LUNR is the first of multiple phase three pivotal trials set to read out over the next year and a half, each focused on a population with high unmet needs. Later this year, we expect to announce top-line results from the Phase III Pivotal Innovate III trial in platinum-resistant ovarian cancer. In early 2024, we anticipate the top-line results from the Phase III Pivotal METIS trial, evaluating the use of TT fields for the treatment of brain metastases from non-small cell lung cancer. And following the completion of the 18-month follow-up of the last patient enrolled we expect top-line readout of the Phase III pivotal Panova III trial in locally advanced pancreatic cancer in 2024. These pivotal clinical trials will provide the foundation for the next stage of Novacure's growth. In the U.S. alone, the number of diagnoses of the cancers treated in these trials is nearly 14 times the annual diagnoses of glioblastoma. an indication in which we have built a strong and sustainable commercial business. The outcomes of these pivotal trials could enable tens of thousands of patients to benefit from TTC therapy. That promise to extend the lives of patients diagnosed with aggressive forms of cancer continues to drive us every day. With the potential to treat many thousands more patients soon, we believe we are one step closer to achieving our mission. I look forward to seeing many of you in Chicago next month and to updating you throughout this exciting time. With that, I will turn the call over to Assas to discuss our commercial business.