NovoCure Limited

Ladies and gentlemen, thank you for standing by and welcome to the NovoCure third quarter 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 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Gabrielle Fernandez, Director of Investor Relations. Please go ahead, ma'am.

Good morning, everyone, and thank you for joining us to review NovoCure's third quarter 2020 performance. With the management team largely working remotely, we are again conducting today's call virtually. I am joined on the phone by our executive chairman, Bill Doyle, our CEO, Saf Donziger, and our CFO, Ashley Cordova. Other members of our executive leadership team are also on the call and available for Q&A. The slides presented today can be viewed on our website, www.novacure.com, by clicking on the link for third quarter 2020 financial results located in the events section of 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, including those risks and uncertainties 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. Following our prepared remarks today, we will open the line for questions. Financials for the three and nine months ended September 30, 2020, are available in our press release and in our 10-Q, both of which we released earlier this morning. Where appropriate, we will refer to non-GAAP financial measures to evaluate our business. Reconciliations of non-GAAP financial measures to GAAP financial measures are also included in our press release, in the appendix of the supplemental slides accompanying this presentation, and in our Form 8-K filed with the SEC today. These materials can be accessed from our investor relations page of our website, www.novacure.com. With that, I will now turn the call over to Bill Doyle.

Thank you, Gabby, and good morning, everyone. We remain focused on three overarching priorities at Novacure. First, to further strengthen our established commercial business treating patients diagnosed with glioblastoma or mesothelioma. Second, to advance our clinical pipeline across multiple solid tumor indications, and third, to improve our tumor treating fields delivery system, all with the goal to extend survival in some of the most aggressive forms of cancer. We made important progress across our organization in the third quarter, despite the prolonged industry-wide complexities and uncertainty posed by COVID-19. Driven by our team's solid execution we delivered another record quarter of financial performance with $133 million in net revenue and $0.09 in earnings per share. Our financial strength demonstrates the resilience of our business model and enables increasing investments to accomplish our priorities. We believe our investments in our commercial, clinical, and engineering capabilities are instrumental to unlocking the long-term value of the tumor treating fields platform. With readouts from key clinical trials in multiple indications anticipated over the next few years, we are actively working to ensure organizational readiness for the company's next chapter. Novacure's track record of innovation and financial performance is a testament to the strength of our organization. In August, we further solidified our executive leadership team with the appointment of Wilco Grunhausen to an expanded chief operating officer role, the promotion of Ashley Cordova to Chief Financial Officer, and the promotion of Frank Leonard to the newly created position of Chief Development Officer. Wilco, Ashley, and Frank's extensive experience and many contributions to Novacure's successes to date instill confidence that our expanded leadership team is well-equipped to advance the company's priorities during the period of significant innovation and growth anticipated in the coming years. Our belief that the tumor treating field's mechanism of action is broadly applicable to solid tumor cancers is supported by a scientific rationale grounded in 20 years of preclinical research. Building upon this compelling body of scientific evidence, we continue to invest in translational research to deepen our understanding of tumor treating field's effects on cancer and to fuel development of new treatment strategies. Just this month, we entered into a strategic alliance with the NYU Grossman School of Medicine's Department of Radiation Oncology that provides a framework for preclinical and clinical development projects studying tumor treating fields. The research to be conducted is geared to further the understanding of the interaction between tumor treating fields and radiation therapy, to study tumor treating fields in combination with various pharmacological agents, and to identify new indications for use. We are excited to partner with a leading U.S. academic institution and look forward to working with NYU's top researchers. We believe that collaborations with leading academic research centers signifies growing interest in tumor treating fields across the scientific community and advances our mission to extend survival in the aggressive cancers we treat. Shifting to our clinical pipeline, we continue to progress trials to generate data on the safety and efficacy of tumor-treating fields therapy and new indications. Our teams are diligently enrolling randomized Phase III pivotal trials in brain metastases, lung cancer, pancreatic cancer, and ovarian cancer. We have ongoing Phase II pilot studies in gastric cancer and in recurrent GBM, testing a new high-intensity array system, which we launched last quarter. we made considerable progress towards opening our Trident trial, a randomized post-marketing study in newly diagnosed GBM to study the potential survival benefit of initiating tumor treating fields therapy concurrent with radiation therapy. We have secured all necessary regulatory approvals for Trident and conducted our first site initiation visit in the United States. We anticipate first patient enrollment in Trident prior to year end. We are seeing early signs of stabilization in the clinical trial environment in certain geographies, despite persisting pressure and uncertainty caused by COVID-19. In our ongoing clinical trials, we remain focused on opening additional sites and increasing site engagement. Through our partnership with Xilab, we expect to begin opening new trial sites in China to drive enrollment in some of our phase three trials beginning in 2021. In the third quarter, we added a total of 29 new clinical trial sites in the U.S. and Europe across our Phase III programs. Notwithstanding this progress, we continue to work closely with institutions, local authorities, and contract research organizations to monitor the dynamic COVID-19 environment and to refine our processes as needed to advance our clinical research studies. In July, we completed enrollment at the HEPA-NOVA trial, phase two pilot trial in liver cancer, and we expect final data from this study in the first quarter of 2021. The HEPA-NOVA data will mark the first of multiple data readouts we anticipate during the next few years, creating the potential for significant market expansion into multiple solid tumor indications with high unmet needs. Beyond our clinical development programs, we continue to expand our programs to deliver technology innovations intended to improve our therapy's efficacy and our product's ease of use, guided by scientific evidence of tumor-treating fields' optimal application. In his new role as Chief Development Officer, Frank Leonard is charged with leading the overall strategic and operational development of Novacure's innovation platform, including product development and business development. Under Frank, we have strengthened our innovation capabilities with teams dedicated to tumor treating fields generators, transducer arrays, and software applications. As with radiation therapy, treatment planning is an essential process to optimize the tumor treating fields energy delivered to the region of a patient's tumor. Guided by research that demonstrated improved survival in newly diagnosed GBM patients who received higher doses of tumor treating fields therapy. Last quarter, our software applications team completed initial development of a new treatment planning software package we call MaxPoint. We have commenced beta testing of MaxPoint with a select number of radiation oncology partners. Research and development are central priorities at Novarture, and we are excited to highlight our programs as they progress. We believe we are in the early stages of our therapy's evolution, and our confidence in the potential of tumor-treating fields to make a difference in the lives of cancer patients continues to build. We invite you to join us for a virtual R&D day on November 12th. During the session, we plan to highlight development pipeline progress and review areas of internal and external focus in our translational research. With that, I'll turn the call over to Asas to share his perspective on the third quarter. Asad?