NovoCure Limited

Good day and thank you for standing by. Welcome to the NovoCure Q3 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker 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. Please go ahead.

Good morning, and thank you for joining us to review Novocare's third quarter 2023 performance. I'm on the phone this morning with our executive chairman, Bill Doyle, our CEO, Asaf Donziger, 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 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'll 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 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 file 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 the development of our novel therapy tumor treating fields. This quarter, we made progress on numerous fronts in pursuit of our mission. Before we review the quarter, I would like to address the evolving situation in Israel. NovoCure was founded in Israel. And as we've grown, our Israeli DNA has remained an important part of our culture and identity. We have 260 colleagues in Israel and hundreds of current and former patients who are affected by the terrorism of October 7th and its horrific aftermath. We are living with grief, shock, fear, anger, and sorrow. We will do everything in our power to buttress members of the Novocare family Our thoughts and prayers are with everyone affected by these devastating events. Shifting back to our quarterly results, Q3 was a period of continued execution at Novacure. We finished the period with 3,639 global active patients on therapy and significantly added to the body of clinical data supporting the use of TT field therapy across multiple cancer indications. We also made meaningful progress on our pipeline, including our next series of clinical trials and product development enhancements. This morning, we will begin with an update of our lung cancer program. We will then discuss our other clinical programs and our commercial business. We will close with a review of third quarter financials. In Q3, We continue to strengthen the foundation of clinical data supporting the use of PP Fields therapy, especially in our thoracic program. In August, the results of the phase three lunar clinical trial in metastatic non-small cell lung cancer were published in the journal Lancet Oncology. As a reminder, the lunar data showed a statistically significant and clinically meaningful extension in overall survival for patients treated with TT Fields therapy and the standard of care, exhibiting 13.2 months median overall survival compared to 9.9 months for patients treated with standard of care alone. The results were more pronounced in patients who received TT Fields therapy and an immune checkpoint inhibitor, demonstrating 18.5 months median overall survival compared to 10.8 months in patients treated with an immune checkpoint inhibitor alone. Lancet Oncology is one of the premier clinical oncology research journals. We are proud to have the lunar data published in this prestigious and impactful platform. In addition to the Lancet publication, several key post-hoc analyses of lunar were presented at major medical congresses during the third quarter, further illustrating the broad and growing interest in the lunar clinical trial. Key among these was an analysis of survival patterns for lunar patients with known tumor progression scores, presented at the ICELAC World Conference on Lung Cancer in September. This analysis showed that patients treated with PT fields and an ICI with TPS scores greater than 1% exhibited a substantially longer median overall survival compared to those patients treated with an immune checkpoint inhibitor alone, 23.6 months compared to 10.5 months. Further, in patients with low TPS scores, between 1 and 49%, median overall survival reached 19 months in the TT Fields Plus ICI arm versus 9.7 months for treated with an ICI alone. While sample sizes are small, these data support the potential of TT fields to materially extend survival in a large subpopulation of non-small cell lung cancer patients who may not be prime candidates for immune checkpoint inhibitor monotherapy and who could benefit from the addition of TT fields therapy to their pharmacological therapies. The robust extension and survival demonstrated in LUNR is key to our ongoing efforts to further explore the capabilities of tt fields and immune checkpoint inhibitors for the treatment of non-small cell lung cancer in october at the european society of medical oncology conference we presented health-related quality of life data from a lunar trial consistent with all our previously conducted trials The use of TT fields in the lunar study did not result in an increase in systemic toxicity and did not impact the health-related quality of life of patients in the study. Also in October, at the American Society for Radiation Oncology annual meeting, we presented a simulation showing the ability to treat cancerous lung tissue with TT fields regardless of a patient's body mass index. These analyses underscore the applicability of PP fields to treating metastatic non-small cell lung cancer and the growing interest in the lunar data set within the oncology community. On the regulatory front, our teams are on track to submit the final module of our PMA application to the FDA later this year. This comes on the heels of our completed European CE mark application last quarter. The lunar trial is an important milestone, as it is our first randomized clinical trial demonstrating extended survival in the treatment of cancers of the torso. We are now advancing our plans for our next lung cancer clinical trials. These next lunar trials will explore the use of PT fields together with immunotherapies, which showed immense promise in our first lunar trial. Success in these trials will allow us to expand the lung cancer patient population, indicated for TT Fields therapy. Beyond our thoracic program, we have two randomized Phase III clinical trials nearing major milestones. Topline data from the METIS trial is expected late in Q1 2024. METIS is evaluating the use of TT Fields therapy to treat brain metastases from non-small cell lung cancer following stereotactic radiosurgery. And in the second half of 2024, we expect top-line data from the PANOVA-3 trial. PANOVA-3 is evaluating the use of PT field therapy together with NAB, paclitaxel, and gemcitamine for the first-line treatment of locally advanced pancreatic cancer. In Q3, we also made progress in our PANOVA-4 study, which is exploring the use of PT field therapy together with atezolizumab. for the treatment of metastatic pancreatic cancer. Penova 4 enrolled its first patient and is now open and actively recruiting patients. Finally, in the third quarter, we announced the top-line results from the Innovate 3 trial in platinum-resistant ovarian cancer. Innovate 3 did not meet its primary endpoint. Platinum-resistant ovarian cancer is a difficult-to-treat condition And while we were disappointed with the top line results of Innovate 3, we obtained key learnings for the design of future trials. Most notably, we saw a promising survival trend in patients who entered the trial after failing a single previous line of platinum therapy compared to those enrolled after failing multiple lines of therapy. The benefit observed for women who enrolled in Innovate 3 earlier in their cancer therapy journey reinforces our understanding that PT fields therapy is at its most effective when used early on and informs our plans for future trials. I'd like to close today by reiterating my enthusiasm for the milestones we have reached this year and for those to come in the near future. With two phase three trial readouts and our launch in non-flaw cell lung cancer on the docket for 2024, The future is bright for NovoCure, and we look forward to the opportunity to treat many more patients suffering from difficult-to-treat cancers in the coming years. I will now turn to Asaf to discuss our GBM business.