NovoCure Limited

Good day, ladies and gentlemen, and welcome to NovaCorp third quarter 2021 earnings conference call. At this time, all participant lines are in a listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will be given at that time. To ask a question, you will need to press star, then 1 on your telephone. As a reminder, this call is being recorded. If anyone should require operator assistance, please press star, then 0. I would now like to turn the call over to your host today, Ingrid Goldberg, Vice President of Finance and Investor Relations. Please go ahead.

Good morning, everyone, and thank you for joining us to review Novacure's third quarter 2021 performance. I'm joined on the phone by our Executive Chairman, Bill Doyle, our CEO, Asaf Danziger, and our CFO, Ashley Cordova. Other members of the 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 to the third quarter 2021 financial results located in the events section of our investor relations page. Before I 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 your questions. Financials for the three and nine months ended September 30th, 2021 are available in our press release and in our 10Q, both of which we released earlier this morning. Where appropriate, we 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 8K file with the SEC today. These materials can also be accessed from our Investor Relations page of our website. With that, I will now turn the call over to our Executive Chairman, Bill Doyle.

Bill Doyle Thank you, Ingrid, and good morning, everyone. At NovoCure, we are focused on our mission to extend survival in some of the most aggressive forms of cancer. Tumor treating fields is a platform therapy, and the totality of 20-plus years of scientific research supports our belief that we can safely use tumor treating fields with the evolving standards of care in a multitude of cancer indications. We also have numerous opportunities to explore improving our therapy to further enhance efficacy and ease of use for our patients and caregivers. Our clinical trial pipeline is robust. and continues to grow with organic research opportunities yet to be explored. We have an extensive intellectual property portfolio that we are consistently expanding and will rigorously defend. Since our founding over 20 years ago, we have established a cancer therapy business model that is unique, expandable, and repeatable. Our international GBM business is cash generative, and is supporting the significant investments we are making to generate future growth. With multiple late-stage trials set to read out in the next 24 months, we believe Novacure is approaching a key inflection point for patients and our organization. As we close in on these milestones, and with the stability provided by over $900 million in cash on hand, we are aggressively investing in our pipelines, and product development efforts to bring our novel therapy to many more patients in need. In summary, the fundamentals of our business are strong and we are energized by the opportunities before us to help many more cancer patients and to grow our company. Before we discuss our quarterly results, I would like to announce that we have enrolled the last patient in our phase three pivotal Innovate3 trial for the treatment of platinum resistant ovarian cancer. This is a major step forward for our clinical trial program and is an important achievement for all of those involved. Asaf will provide more detail on the next steps momentarily. In today's call, first we will discuss updates from the quarter in our core GBM business. We will then turn to our recent clinical development progress. we will underline the financial power and flexibility afforded by our sustainable business model. Our GBM business continues to fuel our aggressive investment in future growth initiatives. This quarter, we generated $133.6 million in global revenue and ended the quarter with over 3,500 active patients on therapy. We invested $48 million in research and development, bringing our total investment in R&D during the first three quarters of the year to $144 million, nearly 10% more than the total amount invested in all of 2020. Our GBM growth strategy focuses on broadening our eligible patient population through expansion of our geographic footprint and label, as well as increasing penetration in our current markets. We believe further engagement with key academic centers is paramount to our penetration efforts. We have identified academic centers which see a sizable portion of the GBM population where we are under-penetrated. We are pursuing opportunities to increase and expand touchpoints with these centers. Our teams have opened multiple clinical trials at key academic centers with several site initiations scheduled. we have launched multiple investigator-sponsored trials, such as Dr. Solti's study at Stanford University, examining the effects of hypofractionated chemoradiation plus TT fields. Both our clinical trials and investigator-sponsored trials offer unique opportunities for academic practitioners to experience hands-on use of TT fields in their patient populations. I would be remiss if I did not mention the ongoing impacts of the pandemic on our commercial business. Broadly, we have seen COVID-19 reduce cancer patient engagement with physicians, delay surgeries, and stress hospital staffing at all levels, all of which can affect a patient starting Optune at the ideal time. Policies adopted by hospitals to prevent infections and manage COVID-19 caseloads have reduced our ability to interact with some oncologists. These challenges wrought by the pandemic ebb and flow regionally with COVID case volumes. We are monitoring these situations daily and doing everything in our power to be nimble and innovative to provide TT Fields therapy to all the patients who may benefit from it. Outside of GBM, we announced several notable achievements this quarter. In September, we announced a new clinical collaboration with Roche. to co-design a single-arm trial to study the use of tumor-treating fields together with the anti-PD-L1 therapy adizolizumab for the first-line treatment of metastatic pancreatic ductal cancer. Preclinical data suggests TT fields together with immune checkpoint inhibitors can result in increased tumor control. Up till now, The immune-shielded environment of the pancreas has proved to be difficult for immunotherapy agents to penetrate, and multiple clinical trials have failed in this high unmet need indication. We believe the use of tumor-treating fields and atazolizumab may finally make an impact for patients diagnosed with pancreatic cancer. We are extremely excited to begin our work with another global oncology leader. Also this quarter, the FDA granted breakthrough device designation for the NovoTTF-200T system for the treatment of advanced liver cancer. As we look ahead to a future phase three trial in liver cancer, breakthrough device designation offers the opportunity to interact directly with FDA experts through the pre-market review process and allows for prioritized review of regulatory submissions. We also announced the final patient enrollment in our EF31 single-arm trial studying the treatment of gastric cancer together with our partner, XyLab. As a reminder, gastric cancer is the third most common cancer in China and has a poor prognosis with median overall survival rates of approximately one year. Now that EF31 has completed enrollment, We look forward to beginning the data analysis process and are on track to release data in 2022. Finally, we recently celebrated a milestone internally that I'd like to share with you. Daniel Torres was the first patient in the U.S. to enroll in our Phase III EF11 GBM trial 15 years ago. This summer, Daniel celebrated his 66th birthday with his wife and four children in Chicago. Daniel's milestone is a strong reminder to everyone at NovoCure of why our efforts are so important. We are working to extend survival for patients diagnosed with some of the most aggressive forms of cancer, so patients like Daniel can celebrate more milestones with their loved ones. I would personally like to thank Daniel for being a wonderful ambassador for our company and an inspiration to the NovoCure team. With that, I will now pass the call over to Asaf, who will discuss our pipeline updates. Asaf?