NovoCure Limited

Good day and welcome to the NovaCare Q1 2022 earnings call. At this time, all participants are in a 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 then 1 on your touchtone telephone. If anyone should require assistance during the call, please press star then 0 to reach an operator. As a reminder, this call may be recorded. I would now like to turn the call over to Ingrid Goldberg. You may begin.

Good morning, everyone. And thank you for joining us to review Novacure's first quarter 2022 performance. I'm joined on the phone by our executive chairman, Bill Doyle, and our CFO, Ashley Cordova. Our CEO, Asaf Donziger, and 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 for first quarter 2022 financial results located in the quarterly report 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. Where appropriate, we will 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 attributed to our capital structure, tax rate, and material non-cash items, and best reflects the financial value generated by our business. Reconciliations of this and any other 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. Following our prepared remarks today, we will open the line for your questions. Financials for the three months ended March 31st, 2022 are available in our press release and in our 10Q, both of which we released earlier this morning. With that, I will now turn our call over to our Executive Chairman, Bill Doyle.

Thank you, Ingrid. At Novacure, we are focused on our mission to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our innovative therapy tumor-treating fields. Since our founding over 20 years ago, we have completed multiple pivotal trials in glioblastoma, established a sustainable commercial business, and built a robust clinical pipeline that we believe will enable our company to serve thousands of future patients. We believe we are just scratching the surface of the ultimate potential for tumor-treating fields to extend the lives of cancer patients. For years, through our commercial and clinical research programs, we have worked to extend the pool of patients who potentially can benefit from tumor-treating fields therapy. With multiple key milestones anticipated in the near term, we are on the verge of realizing that goal. Over the next 24 months, we anticipate data readouts from several pivotal trials across a variety of solid tumor cancers. We also expect exciting product development improvements to reach cancer patients later this year. Finally, in addition to expanding our commercial footprint in glioblastoma, we are laying the pre-commercial foundations for multiple launches in new indications. In today's call, we will begin with a review of our commercial execution in the quarter. We will then discuss the near-term catalysts within our clinical pipeline. Finally, we will close with a discussion of our first quarter financial performance. Our GBM business remains a key driver of our long-term success, providing the critical financial support for our investments in future growth. Our GBM business also provides the commercial blueprint across numerous regions for potential future launches in new indications. Our GBM commercial strategy is focused on broadening our eligible patient population and driving greater penetration in our current markets. Geographic expansion is a key pillar of our strategy to expand the eligible GBM patient population. France is the next major market in which we are pursuing reimbursement. Discussions with French health authorities are ongoing, and we anticipate reaching agreements on the terms of national reimbursement and launching in France by year end. We are actively building up commercial infrastructure in additional markets in North America and EMEA, with the goal of making PT field therapy available to many more GBM patients in need. In-person education is the most fruitful approach to convince healthcare providers of the value to patients of using Optune therapy and to increase adoption in our current markets. Though face-to-face contact has been severely constrained due to the pandemic, we are seeing early signs of some COVID-related restrictions lifting in areas of the U.S. That said, we believe the return to normal prescriber access will be gradual as providers continue to wrestle with staffing shortages and turnover. We are hopeful that the current reopening trends hold and markets continue to normalize as we head into the summer. Academic centers remain an area of under-penetration. These centers treat a significant portion of GBM patients and are key to increasing broader adoption of tumor-treating fields. We work to engage academic oncologists on the clinical frontier through our GBM-focused trials. Our Trident trial in newly diagnosed GBM has proven to be a productive avenue to engage expert academicians. As a reminder, Trident is studying the use of tumor-treating fields concurrently with radiation therapy rather than following radiation in newly diagnosed GBM patients. This study is enrolling well, and we now have 92 clinical sites actively recruiting. Our investigator-sponsored trial program is another tool to engage and collaborate with academic oncologists. We currently support 37 ISTs, with a number focusing on new approaches to treating GBM, including novel therapy combinations and new patient populations. Trident and our IST program are paramount to generating more clinical data and building greater understanding and awareness of our therapies. Turning to our clinical pipeline, in 2022, we expect to release data from both pivotal and pilot studies, complete enrollment of another pivotal trial, and commence a limited release of our next-generation arrays. 2022 is the first of several years in which we expect to reach clinical milestones. As a reminder, we currently have four Phase III pivotal studies ongoing and expect to read out in the near term. The first to read out will be our LUNR study investigating the safety and efficacy of tumor treating fields together with docetaxel or physician's choice PD-1 inhibitor in non-small cell lung cancer. We anticipate LUNR top line data by year end following 12 month follow up from last patient in. LUNR is critical as it has the potential to unlock an entirely new patient population that can benefit from tumor treating field therapy. The LUNAR protocol contemplates multiple global standards of care, enabling tumor treating fields to work concomitantly with a number of treatment regimens in non-small cell lung cancer, which vary by geographic region. Next, we expect to complete the follow-up period of our INNOVATE III study in the first half of 2023. As a reminder, the pivotal INNOVATE III study is investigating the efficacy of TT fields and paclitaxel for the treatment of recurrent ovarian cancer. We completed enrollment of INNOVATE III in the fourth quarter of last year and in March received a recommendation from the DMC to continue the trial to completion. We are now following patients through the 18 months from last patient and follow-up period before releasing data in 2023. The third of our current pivotal studies to read out is our METIS study, which is investigating the use of TT fields following stereotactic radiosurgery for the treatment of brain metastases from non-small cell lung cancer. We expect a complete enrollment of METIS later this year. Final data will be available in 2023 following the completion of a 12-month last patient and follow-up period. Our Panova 3 study is investigating the efficacy of TT fields together with gemcitabine and nabpaclitaxel for the treatment of locally advanced pancreatic cancer. Pancreatic cancer holds one of the most devastating prognoses with a five-year survival rate of only 11%. We expect a complete enrollment of Panova 3 in 2023 with data to follow in 2024. I would also like to mention the EF31 pilot study investigating the safety and efficacy of PT fields together with chemotherapy in gastric cancer, for which we will share data in the coming months. Gastric cancer is one of the most prevalent cancers in Asia, with nearly half a million annual diagnoses in China alone. EF31 is a single-arm Phase II study that is the next clinical step in our abdominal cancer program. We are looking forward to sharing the data from EF31 with you and to reviewing potential next steps in gastric cancer. Each of our clinical trials takes years to design, execute, and read out. I am grateful for the tireless effort and dedication of our Novacure teams, investigators, and patients. We are at the beginning of a transformational period for our company. In the next eight months, we anticipate vital clinical data from pivotal and pilot trials, completion of enrollment of our third pivotal study in less than 12 months, and a meaningful product development milestone with European market release of our next generation arrays. Swiftly following these milestones, we expect to share additional pivotal data sets and potential new indications. Collectively, these trials could increase Novacure's addressable patient population by over 10 times, offering new treatment solutions for tens of thousands of cancer patients. I'd like to conclude my comments today by highlighting one of our remarkable patients. Wade Lewis was diagnosed with GBM in 2019 and will soon celebrate his second anniversary on Optune Therapy. Following his diagnosis, Wade formed a uniquely strong bond with neuro-oncologist Dr. Ekakobi Fonkum of Baylor Scott & White Health, through their mutual belief in serving others. As a visionary thinker, Dr. Fonkum is one of the founders of the Society of Neuro-Oncology, Sub-Saharan Africa, and together with Wade, recently completed filming a documentary to drive greater awareness in GBM. It is an inspiration to see our patients and physicians working together to advance patient care and reach more GBM patients in need. I will now turn the call over to Ashley to discuss our first quarter financial performance.