NovoCure Limited

Good morning, everyone, and thank you for joining us to review Novocure's fourth quarter and full year 2022 performance. I'm joined on the phone by our Executive Chairman, Bill Doyle, our CEO, Asaf Dhanziger, 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, under quarterly reports on our investor relations page. Before we begin, 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 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 before interest, taxes, depreciation, amortization, and share-based compensation. We believe Adjusted EBITDA is an important metric as it removes the impact of earnings of triple-two, our capital structure, tax rate, and material 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 8K file with the SEC today. These materials can also be accessed from our 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, everyone. NovoCure was founded in 2000 to exploit the novel finding that electric fields can be harnessed to kill cancer cells and extend cancer patient survival. Since 2000, we have treated over 27,000 patients, built a resilient commercial business, and invested in extensive clinical and product development programs to enhance and expand the incredible capabilities of tumor treating fields therapy for the treatment of solid tumor cancers. In 2022, Novacure achieved material milestones. In our commercial business, we generated $538 million in net revenue, received approval for and launched Optune in Canada, and finalized contract terms to establish national reimbursement in France pending final publication. We successfully rolled out our next-generation arrays in Austria, which are thinner, lighter, and may deliver more energy to patients. And we made significant progress in our clinical programs, announcing the pivotal lunar study in non-small-cell lung cancer met its primary overall survival endpoint, completing the pivotal Innovate 3 interim analysis with final Innovate 3 data anticipated later this year, and announcing positive data in our pilot gastric cancer study and in Dr. David Tran's to-the-top pilot study, which explored treating GBM patients with TT fields plus temozolomide and the immune checkpoint inhibitor pembrolizumab. Last week, we announced completion of enrollment of our pivotal Panova 3 study in pancreatic cancer. And as of this morning, we are just two patients away from completing enrollment of our pivotal meta study in brain metastases from non-small cell lung cancer. 2022 was a year of solid execution that will shape the future of our company. And our teams are excited and motivated for all that awaits us in 2023. We will begin today's call with a discussion of our GBM business. We will then review our clinical pipeline and near-term milestones. Finally, we will review our financial performance in the fourth quarter of 2022 before opening the line for questions. Our commercial business treating newly diagnosed GBM patients provides a solid foundation for growth. We have gained essential knowledge, built critical infrastructure, and established the financial strength to support future launches and new indications. In 2022, we generated over half a billion dollars in net revenue and ended the year with 3,430 active patients on therapy. The GBM business is strong and sustainable, with penetration rates ranging from 30% to 40% in our key markets. but we know that there are many more GBM patients that can benefit from TT Field Therapy. As such, we remain focused on engagement and education of healthcare providers, patients, and caregivers. Last year, we reorganized our GBM team, bringing sales, marketing, and medical leadership under one umbrella with the intention to streamline decision-making and improve coordination with the goal of renewing growth in our CNS business. We are also focused on driving greater awareness of Optune among patients. Seven years since FDA approval in newly diagnosed GBM, some providers still see TT Fields as a new and experimental therapy. We want to ensure patients are aware of the benefits of Optune and are fully equipped to advocate for TT Fields treatment in appropriate situations. To this end, we have bolstered our patient-focused marketing efforts and are pursuing greater awareness across a variety of traditional and new media channels, including social media. We believe our educational efforts with providers and patients, as well as our streamlined commercial structure, will provide the foundation to return to growth in the coming years and provide a blueprint for commercial launches and other indications. Published data and real-world evidence are paramount when working to change the standard of care and shift physician practice. In 2022, we saw a bevy of real-world evidence publications supporting the use of TT fields. These studies have included large populations, such as Dr. Corey Neff of Duke University's review of central brain tumor registry and IQVIA treatment data from 2015 through 2021, spanning 19,000 patients in the U.S. treated for GBM. Others have analyzed long periods at a single center, such as the study from Nahumulka Hospital in Prague, which tracked GBM patients treated with TT fields over 18 years. We have also seen multiple real-world evidence studies from our key Asian markets. A recent review in Frontiers in Oncology by Dr. Zhu Du of North Sichuan Medical College found that the average growth rate for publications related to TT fields was 29% and stated that studying the therapeutic potential of TT fields has become a research hotspot. The common theme of these publications has been the validation and in many cases improvement over the results of our pivotal EF14 clinical study. The real-world studies contribute to the opus of clinical evidence supporting the use of TT fields and will be crucial to our efforts to drive greater adoption. I would like to close today with a discussion of the positive top-line results from our pivotal lunar study. As a reminder, LUNR was designed to evaluate the use of PT fields together with either immune checkpoint inhibitors or docetaxel for the treatment of stage 4 non-small cell lung cancer following first-line progression with a regimen including platinum-based chemotherapy. In January, we announced LUNR met its primary endpoints. demonstrating a statistically significant and clinically meaningful extension in overall survival for patients treated with TT fields together with standard therapies. Further, we saw a statistically significant and clinically meaningful extension in overall survival for patients treated with TT fields and immune checkpoint inhibitors versus immune checkpoint inhibitors alone. and a positive trend in overall survival for patients treated with TT fields and docetaxel versus docetaxel alone. We believe these data represent a crucial finding for patients diagnosed with stage 4 non-small cell lung cancer. In the U.S., 46,000 non-small cell lung cancer patients seek treatment in the second line each year, as do thousands more around the world. Since pembrolizumab was approved in this setting in 2016, there has been little progress in extending survival for these patients. We believe the lunar data have the potential to transform the treatment paradigm for these patients and more generally point to the future of solid tumor therapy. Our team continues to analyze the data in preparation for a full presentation and publication and we look forward to sharing the data with physicians, patients, and investors later this year. With that, I will now turn to Asaf to discuss other updates in our clinical and product development efforts.

Thank you, Bill. I would like to echo Bill's excitement about the positive top-line readout of the Lunar study. Lunar is a key achievement for NovoQ. Lunar is our first pivotal study completed with immunotherapies and our first pivotal study treating solid tumors outside of the brain. It is also the first of four pivotal studies which we expect to read out in the coming two years, which, if successful, will transform our company. I began my career at NovoQ in 2002, more than 21 years ago, and I can attest that I have never felt more engaged or excited. Our employees have worked so hard And I'm so eager for what awaits us. At an upcoming medical congress, we will present the full lunar data set. In summer and fall, we expect to release the top line and full results of the INNOVA3 pivotal study in ovarian cancer. Early next year, we anticipate top line data from the METI study. Shortly thereafter, we expect to announce the Panova3 top line readout. And at about the same time, we anticipate commercial launches in non-small cell lung cancer and ovarian cancer, with more to come in 2025 and beyond. This is an incredible time to be at NovoQ. I would be remiss to not mention the team's recent achievement launching our next generation array in select European markets. Our new arrays are thinner, lighter, and more flexible than previous versions. They can also optimize the intensity of TT fields delivered to the tumor without a material increase in heat delivered to the scalp. Preclinical research has shown that increased intensity delivered to a patient's tumor bed can potentially increase the efficacy of TT fields therapy without an increase in systemic toxicity. We are utilizing this limited release to study patient use patterns with the new arrays. The data gathered will inform future launch plans in additional markets. After the successful launch in Austria, we are preparing to expand the program to Sweden. Our new arrays are the first of what we expect to be a long line of product enhancements designed to optimize TT fields therapy. Before handing the call to Ashley, I would like to thank my colleagues at NovoQ for a successful 2022. Through your hard work, We have positioned ourselves to take advantage of immense opportunity in the coming years. I know you will all rise to the occasion, as you have many times in the past. I will now turn the call over to Ashley to review our fourth quarter financials.