NovoCure Limited

Good day, and thank you for standing by. Welcome to the Novocure Q4 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 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, and thank you for joining us to review Novocare's fourth quarter 2023 performance. I'm joined this morning by our Executive Chairman, Bill Doyle, our CEO, Asaf Danviger, and our CFO, Ashley Cordova. Other members of the executive leadership team will be available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.novacure.com, 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. At NovoCure, Our mission is to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our novel therapy tumor treating fields. In 2023, we made notable strides and reached many important milestones in our commercial, clinical research, and product development programs. Our commercial business treating patients with GBM finished the year with 9% year-over-year growth in active patients on therapy. our LUNR Phase III trial in non-small cell lung cancer met its primary endpoint. We completed enrollment of two additional Phase III trials, METIS and Panova III, and we completed enrollment of the Trident trial in January. We launched LUNR II and Panova IV, which are now initiating sites and enrolling patients, and the protocols of two new clinical trials, Keynote D58 and LUNR4 are under regulatory review. We successfully introduced our next generation arrays in several European countries and filed a PMA supplement for approval to bring the new arrays to patients in the U.S. Importantly, we have now treated over 30,000 patients since we first started commercial operations, and we ended the year with a record number of active patients on therapy. I am incredibly proud of our colleagues' achievements and look forward to a data and catalyst-driven 2024. 2024 is an important year for Novarture with more milestones on the horizon. We are laser-focused on achieving three core objectives, growing our GBM business, launching Kiki Fields in non-small cell lung cancer, and delivering our clinical and product development pipelines. Achieving these objectives will position our company for success for years to come. I'll begin this morning with a review of our commercial GBM business and non-small cell lung cancer program. Asaf will then provide clinical trial and product development updates, followed by Ashley's review of our financial performance. Our commercial GBM business is key to our long-term success. Thriving growth in our core country markets is a central objective in 2024. We ended 2023 with a record 3,755 active patients on tumor treating field therapy and generated $509 million in net revenue for the year. To achieve our growth goals, we are focused on building greater awareness and engagement with patients and prescribers, and enhancing the quality of these engagements. We are focused on seamless cross-functional alignment and a synchronized approach to driving the key levers of growth, prescriptions, patient starts, compliance, and therapy duration. Each of these inputs is critical for the best outcomes for patients and to achieving sustainable growth. We have always been a data-driven organization. As healthcare providers move to further integrate TT Field Therapy into their practices, we are determined to provide the clinical data to best inform TT Field Therapy use. A critical part of this effort is the generation of real-world evidence. Last month at J.P. Morgan, we shared a preliminary analysis of a real-world study which included all 974 newly diagnosed GBM patients who began Optune GO treatment in the U.S. in the second half of 2019. The four-year survival rate of these patients was 24%, compared to 8% for patients treated with chemotherapy alone, historically. It is worth noting that the real-world data fully support the results from the landmark EF14 Phase III clinical trials. which demonstrated 20% four-year survival for patients treated with TT fields and temozolomide. These new, real-world data will be added to, peer-reviewed, and published later this year. But the bottom line is, large, real-world data sets confirm that tumor-treating fields therapy can provide a significant survival benefit for patients struggling with this devastating disease. As we continue to generate more real-world data, we will be working to increase physician awareness of outcomes and, importantly, build patient awareness of the data. As our therapy is a unique modality, we know that physicians or patients can drive the choice of TT Fields as a therapy option. To this end, we have adjusted our organization to integrate patient support and physician support earlier in the patient journey. Direct engagement with Physicians will enable our teams to provide more hands-on assistance at the time a prescription is considered and written. We believe early engagement with patients will drive higher conversion of scripts to patient starts and deliver a more seamless therapy experience. Our second key objective in 2024 is the regulatory approval and successful launch of tumor treating fields in non-small cell lung cancer. As a reminder, last year we published the results of the Phase III LUNR trial. LUNR showed a statistically significant and clinically meaningful survival benefit for second-line, non-small-cell lung cancer patients who progressed on platinum-based chemotherapy and who used PT fields and standard therapies compared to patients who only used standard therapies. Since announcing positive top-line LUNR data, we have made steady progress towards our goal of commercial launch in 2024. In December, we filed the necessary regulatory submissions in our three major markets, the US, Europe, and Japan. In January, the FDA formally accepted our PMA submission for filing, and the PMA is now under substantive review. At the 100-day mark, which will occur in mid-March, we anticipate meeting with the FDA to discuss their next steps. Our team is fully prepared to address any questions, and we look forward to engaging with the FDA in the coming months. Outside the U.S., we are awaiting a CE mark decision in Europe and regulatory next steps in Japan. Pending regulatory approvals, our goal is to launch in Germany in the first half of 2024 and in the U.S. in the second half. Once we receive marketing approvals, we will engage payers in Germany and the U.S. to establish reimbursement. We plan to start patients on therapy in Germany and the U.S. immediately following approval using a named patient reimbursement process similar to that we used when we launched GBM. We are eager to open this new chapter at Novacure and look forward to potentially treating many more patients in the coming months. In 2024, our teams will also deliver top-line results of the MEDIS and Panova 3 clinical trials. Both trials are fully enrolled and now in patient follow-up. ASAPH will discuss these trials momentarily, but timing indicates Novacure could announce material data or new indication approvals in every quarter of 2024. It's going to be a very exciting year. Before I pass the call to Asaf to discuss our clinical program, I would like to publicly welcome our new chief medical officer, Dr. Nicholas Lepin, who joined NovoCure in January. Dr. Lepin brings a wealth of valuable experience to NovoCure as a former practicing oncologist and as a leader of clinical operations at some of the most innovative biotechnology companies. Nicholas has a proven track record of achievement, and he is making great contributions already. Nicholas and Michael Puri, our new Chief Human Resources Officer, who joined in Q3 2023, are important additions to our executive team. Welcome, Michael, and welcome, Nicholas. I'll now turn the call over to Asaf to discuss our clinical objectives.