NovoCure Limited

Good day and thank you for standing by. Welcome to the Nova Cure Q3 2022 earnings conference call. At this time, all participants are in 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 11 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Ingrid Goldberg.

Good morning, everyone, and thank you for joining us to review Novocare's third quarter 2022 performance. I'm joined on the phone by our executive chairman, Bill Doyle, our CEO, Asaf Janziger, 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.Novocare.com, under quarterly reports on our investor relations page. 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 statements except as required by law. Where appropriate, we 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-GAAP to GAAP financial measures are included in our press release, earnings slides, and in our Form 8K file with the SEC today. These materials can also be accessed from our investor relations page on 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, everyone. At NovoCure, our mission is to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our life-extending therapy tumor treating field. In the third quarter, we consistently executed across our business in service of our mission. Our team is diligently working to reach additional patients in our current markets, expand into new markets, enhance our tumor treating fields delivery systems, and treat patients in new indications throughout the body. We made significant advancements in our clinical and product development programs, and we are eagerly awaiting data readouts from multiple pivotal trials starting in the first quarter of 2023. Our GBM business remains the core driver of our financial stability and enables us to invest aggressively in a variety of clinical and product development initiatives, as well as commercial programs designed to increase adoption. In the third quarter, we generated $131 million in net revenues and $22 million in cash flow from operations. The U.S. market is our largest revenue contributor in which currently approximately 40% of newly diagnosed GBM patients receive a prescription for Optune. We believe there is room to drive greater adoption of Optune in newly diagnosed GBM given the best in class outcomes demonstrated by our EF14 randomized clinical study a growing body of basic and translational science from leading academic research centers, and ongoing confirmation from real-world evidence analyses throughout the globe. There are three key publications that we would like to highlight this quarter. First, a manuscript by Dr. Shadi Shams and Chirag Patel of MD Anderson Cancer Center, which has been accepted for publication in the Journal of Molecular Cell Biology reviews the multiple distinct mechanisms of action of TT fields. This paper is a comprehensive review of TT fields in a high-impact journal and highlights the fast-growing body of scientific research converging to demonstrate the effects of TT fields on cancer growth. The paper validates the multiple ways that TT fields can disrupt critical cellular processes supports TT Fields as a potential backbone therapy for other modalities, and adds to our arsenal of independent support to be used for broader education and awareness. Second, Dr. Shunzhu Chen published real-world evidence from one of the most reputable hospitals in Shanghai, Hushan Hospital, in the Journal of Clinical Medicine. Dr. Chen's analysis reproduces results of the pivotal EF14 study and confirms OpTUNE's efficacy in the largest group of patients treated with TT fields in China to date. Dr. Chen reports a statistically significant 45% improvement in median overall survival with a p-value of less than .001 when comparing TT fields plus temozolomide to temozolomide alone. Third, real-world evidence from Dr. Matt Balow at the West Cancer Center was published in Neuro-Oncology Advances, underlining the benefits of TT Field and demonstrating that greater TT Field exposure correlates to improve overall survival regardless of subgroup or treatment factors. Publications like these serve to strengthen the underpinnings of research supporting the use of our therapy and provide additional educational resources for practitioners as they learn more about PT fields. Next, I would like to highlight the leadership changes we announced last month and the creation of a new U.S. central nervous system cancers franchise. Frank Leonard, who most recently served as our chief development officer, will lead this new organization as franchise president. Frank has succeeded in a number of leadership roles during his 12-year tenure at Novacure. and we believe Frank will drive impactful results in this new role. The new US Central Nervous Systems Cancer Franchise combines sales, marketing, and medical leadership under one umbrella and strengthens our focus on driving adoption of TT fields for newly diagnosed GBM in our largest and most important market. It is important to remember that Optune is still a new therapy to many physicians. The onus is on Novacure, to provide the educational resources needed for prescribing physicians to fully understand the many benefits of TT Fields therapy for their patients. With the creation of the USCNS franchise, we have streamlined decision-making and improved coordination across our US teams with the ultimate goal of increased opt-in adoption in GBM. Continuing the theme of greater TT Fields awareness and education, in August, we introduced a new marketing campaign designed to drive awareness and interest in TT fields in the broader oncology community beyond neuro-oncology. The campaign emphasizes the versatility of the TT fields modality, its multi-mechanistic capabilities, and ability to expand the treatment possibilities for patients. The campaign explained the TT fields are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms, including the disruption of mitosis, interference with cell motility and migration, activation of anti-tumor immunity, and downregulation of genes important for DNA damage repair. One facet of this campaign is the creation of a new tumor treating fields website, which serves as a central educational resource to learn more about our therapy. The website is now live, at www.tumortreatingfieldstherapy.com. I would encourage all of you to explore this resource. Before I turn the call over to Asaf, I'd like to reiterate my excitement for the upcoming Pivotal Trial Readouts. For the last 10 years, Novacure's primary focus has been treating patients with glioblastoma. The top-line readouts from both the Pivotal Lunar and Innovate III studies next year should be transformational for our company and potentially enable tens of thousands of patients to utilize our therapy for treatment of non-small cell lung cancer and ovarian cancer. We look forward to sharing data from these studies with you as soon as possible. With that, I'll turn the call over to Asaf to discuss our clinical and product development updates.