NovoCure Limited

Good morning, everyone, and thank you for joining us to review Novocare's fourth quarter and full year 2020. I am joined on the phone by 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. The slides presented today can be viewed on our website, www.Novocare.com, by clicking on the link for fourth quarter and full year 2020 financial results located in the event 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 filing. 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 12 months ended December 31st, 2020 are available in our press release and in our 10-K, 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.novacare.com. With that, I will now turn the call over to Bill Doyle.

Thank you, Gabby, and good morning, everyone. We started NovoCure with the novel insight that electric fields can be harnessed to disrupt cancer cell division. Two decades later, our mission remains clear. We strive to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our innovative therapy tumor-treating fields. We believe we are in a virtuous cycle of innovation and execution as our commercial business generates the financial strength to invest in innovation that will fuel the future growth of our company. In 2020, our GBM business delivered nearly $500 million in annual net revenues and nearly $100 million in cash flow from operations. Our sustained commercial momentum allows us to continue to make significant investments in our clinical trial programs, product development initiatives, and ongoing research as we work to unlock the full potential of the Tumor Treating Fields platform. We continued our track record of execution throughout 2020 despite the unanticipated prolonged challenges of doing business during the COVID-19 pandemic. Tumor Treating Fields is an emerging cancer treatment modality that requires significant prescriber education to drive awareness and acceptance. For nearly a year, we have relied heavily upon virtual engagement to accomplish our educational objectives. Virtual engagement poses some challenges to effectively communicating and engaging with our healthcare providers and other partners around the world. Notwithstanding these challenges, we believe the fundamental value of the Tumor Treating Fields platform remains unchanged, and our teams are undeterred in their commitment to advance our patient-forward mission. Throughout 2020, we made notable progress to advance our three overarching priorities, to drive commercial adoption in glioblastoma and mesothelioma, to advance our clinical trials in new indications and combinations, and to deliver product innovation to optimize tumor-treating fields therapy. We broadened reimbursement coverage of Optune for GBM across our active markets. China's NMPA approved Optune for newly diagnosed and recurrent GBM, extending the reach of tumor treating fields therapy to the world's largest GBM market. Our clinical teams launched three new clinical trials, which expanded our clinical programs to seven actively enrolling studies involving more than 2,900 patients. We entered into two important clinical collaborations to expand the horizon of tumor treating fields research and development. We advanced multiple product innovations intended to optimize the delivery of tumor treating fields. Notably, we accomplished all of this while we grew net revenues by 41% year over year and added $516 million to our balance sheet. I'll come back to our clinical and product development programs later this morning But first, I want to turn to Asaf to share his perspective on the fourth quarter. Asaf?

Thank you, Bill. I'm grateful to the Novocure team who delivered yet another strong quarter. Global net revenues totaled $144 million, representing 45% growth versus the fourth quarter of 2019. Our net revenue growth was driven primarily by active patient growth and expanded reimbursement for opt-ins. We ended the quarter with more than 3,400 active patients on therapy, an increase of 17% year-over-year. We have now treated more than 18,000 patients globally. Beyond active patient growth, broadening reimbursement coverage also drove revenue growth. With national positive reimbursement decisions to cover Optune in Israel, Germany, and Switzerland last year, we have secured broad reimbursement for GBM in all of our active markets. Most recently, the Swiss Federal Office of Public Health added Optune in combination with hemazolamide for the treatment of newly diagnosed GBM to the list of remedies and equipment, which establishes national reimbursement for Optune effective April 1, 2021. This decision represents an incredible effort by our team to expand access to our therapy, as well as increasing recognition of Optune's benefits among health insurers. Our performance last year underscores the resilience and innovative capacity of the NovoQ team during what was a challenging year across our industry. We believe the prolonged disruption caused by COVID-19 continues to cause increased volatility across global healthcare systems. For example, we have seen fluctuations in the timing of surgeries and radiation therapy in certain regions, which have had some influence on the eligible patient population for Optium. Since last March, we have educated our physicians largely via Zoom and conference calls. Remote interaction has posed some challenges to our ability to engage healthcare providers and partners around the world, despite our efforts to minimize the impact of COVID-19 on our day-to-day operations. Looking forward, we see room for significant growth in our commercial business. Our current penetration rates for GBM range from 30% to 40% globally. We remain focused on driving further penetration through increased engagement with leading academic institutions and continued physician education efforts, particularly among radiation oncologists. We are also working to expand access to our approved indications in new markets. We plan to launch Optium for GBM in France next and recently submitted a full reimbursement package to the French Ministry of Health to establish reimbursement coverage. We are actively evaluating market access pathways to enter additional European markets for our currently marketed indications prior to the expected launch of future indications. We look forward to providing further updates on future calls. As part of our development strategy, we are committed to further extending survivals of patients in our approved indications. In December 2020, we enrolled the first patient in our randomized phase 4 TRIDENT trial in newly diagnosed GBM. TRIDENT tests the potential survival benefit of initiating optionplastimazolamide concurrent with radiation therapy versus following the completion of chemoradiation. TRIDENT is supported by preclinical work that showed TT fields increased sensitivity to radiation therapy and inhibited DNA damage repair. Trident is designed to detect an extension in overall survival of approximately six months. With nearly 100 leading institutions committed to participate in the study, Trident offers the opportunity to engage further with academic centers that conduct GBM research. I want to reiterate how proud I am of the progress made by the NovoQ team throughout the challenging year. To those colleagues listening on the call today, thank you for your commitment to our patient-forward mission. With that, I will turn the call back to Bill to provide more detail about our development pipeline.