NovoCure Limited

Good day and thank you for standing by. Welcome to the NovaCure fourth quarter and full year 2021 earnings conference call. At this time, all participants are in listen-only mode. After the presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star then one on your touchtone telephone. Please be advised today's conference may be recorded. If you require operator assistance during the call, please press star then zero. I'd now like to hand the conference over to Ingrid Goldberg. Please go ahead.

Good morning, and thank you for joining us to review NervaCare's fourth quarter and full year 2021 performance. I'm 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.novacure.com, by clicking on the link for fourth quarter and full year 2021 financial results located in the quarterly report section of 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. 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. 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 measure 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 10-K 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 floor for your questions. Financials for the 3 and 12 months ended December 31, 2021 are available in our press release and in our 10-K, both of which were released earlier this morning. With that, I will now turn the call over to our Executive Chairman, Bill Doyle.

Thank you, Ingrid, and good morning, everyone. We founded NovoCure to exploit the novel observation that electric fields can be harnessed to disrupt cancer cell division. Over the subsequent two decades, Our team has worked tirelessly to bring tumor-treating field therapy to patients to extend survival in some of the most aggressive forms of cancer. Over these years, we have completed multiple pivotal clinical trials, built a durable commercial business treating patients with glioblastoma, and gained an immense amount of knowledge and experience, which fuels our confidence in the future. We continue to develop the full potential of the tumor treating fields platform through research, clinical trials, and collaborations with academic centers and industry partners. The fundamentals of our business are strong. 2021 was another year of achievement for the Novocure team. We completed the enrollment of two randomized pivotal trials, the first in recurrent ovarian cancer and the second in non-small cell lung cancer. We also completed enrollment of a pilot clinical study in gastric cancer. Exciting data from the To the Top investigator-sponsored trial studying tiki fields together with immunotherapy were presented at the Society of Neuro-Oncology Annual Congress, which could lead to a paradigm shift in the treatment of patients with GBM. We also released data from our pilot clinical study in advanced liver cancer, which demonstrated an encouraging disease control rate and objective response rate in poor prognosis patients. We expanded our collaboration network, which now includes oncology leaders Merck, Roche, Genentech, and GT Medical. We announced we are building a world-class training and development center where partners from around the world can convene to learn the latest advances in the study and use of tumor treating fields therapy. And we generated over half a billion dollars in net revenues. As impressive as this progress may be, we believe it is just the tip of the iceberg as we approach a key inflection point for our company and patients. In today's call, we will first discuss recent updates in our core GBM business. We will then review developments in our clinical pipeline. Finally, we will close with a discussion of our fourth quarter financial results and the strengths provided by our sustainable business model. Our core GBM business is a critical driver of Novacure's long-term success. Not only is our GBM business the financial engine fueling significant investment and future growth, it is providing the blueprints for successive successful commercial launches and geographic expansion. COVID-19 was a headwind in 2021. With the Omicron surge repeating patterns of restricted physician engagement, stressed hospital staffing, and delayed diagnosis and treatment seen throughout the year. Nevertheless, we generated $535 million in net revenues from our GBM business, an increase of 8% year over year. A point of focus for increasing octoon adoption is broadening our penetration at key academic institutions. In the U.S., whether through primary consultations or second opinions, Academic institutions see a majority of GBM patient flows, and we remain underpenetrated in these settings. We are committed to providing every opportunity for oncologists at academic centers to learn about the science underpinning tumor treating fields therapy and to increase their understanding of the clinical benefits for patients. I would like to highlight two opportunities for academic oncologist engagement. Our IST program, and the Trident trial in newly diagnosed GBN. Currently, NovoCure supports 30 active investigator-sponsored trials, or ISTs. ISTs explore a variety of clinical topics of interest to academicians, including new cancer indications, unique combinations with drugs and other therapies, and use in new patient populations. NovoCure's IST program offers oncologists opportunities to perform research and publish their findings and informs areas for further study, including potential pivotal trials. Our ISTs can also potentially lead to important breakthroughs, such as the To the Top study conducted by Dr. David Tran, Chief of the Division of Neuro-Oncology at the McKnight Brain Institute at the University of Florida. in newly diagnosed GBM. As seen in our press release this morning, we are extremely pleased to announce Dr. Tran's manuscript was published this week in the Journal of Clinical Investigation. As a reminder, To the Top was designed to study tumor-treating fields with temozolomide together with the immunotherapy pembrolizumab. As with our lunar trial, To the Top explores potential benefits of using TT fields together with immunotherapies, and specifically whether TT fields induce cell death leads to an anti-cancer immune response, such that a formerly cold tumor becomes hot for concomitant use with immunotherapy. In November, at the Society for Neuro-Oncology Annual Congress, Dr. Tran presented preliminary data, which we found very encouraging. In 19 patients that had greater than nine months of follow-up, progression-free survival reached 11.2 months. For perspective, this compares to the 6.7 months achieved in Novacure's pivotal EF14 study of TT fields plus temozolomide and is nearly a three-times improvement to the four months of progression-free survival observed from treatment with temozolomide alone. in the EF14 control arm. Dr. Tran's research might prove revolutionary for GBM patients and may potentially position TT fields as a sensitizer for immunotherapy agents to impact cancers in which they have so far proved ineffective. The To the Top study is an example of a clinical researcher performing an IST that is driving the science exploring the most effective uses of TT fields and may change the treatment landscape for GBM patients. Novacure-sponsored clinical trials provide a second avenue to engage key academic centers. Our Trident protocol is testing the use of TT fields concurrently with radiation therapy rather than following radiation therapy in newly diagnosed GBMs. Studying the earlier introduction of Optune in the GBM treatment protocol is critical to NovoCure for two principal reasons. First, shifting the introduction of TT fields to an earlier point in a patient's treatment journey may lead to extended time on therapy and better survival outcomes. Second, it allows NovoCure to engage additional members of a patient's oncology team, specifically the radiation oncologist. We believe greater awareness of the benefits of TT fields among all members of the treatment team is key to increasing adoption. We have opened Trident recruitment sites at several of our focus academic centers, with the goal of opening Trident sites at all remaining centers this year. Geographic expansion is another key component of our long-term growth strategy. In July, we announced Octoon had earned an ASA3 rating from the French Health Authority. An ASA3 rating enables our team to engage in reimbursement negotiations with the ultimate goal of achieving national reimbursement in France. We are in the final stages of price negotiations with French health authorities and expect to treat patients in France by the end of 2022. In addition to France, we are establishing the commercial foundations in a number of other markets across Europe and Canada. These new markets create the opportunity to serve more GBM patients as well as establish commercial infrastructure in anticipation of future launches. I would like to close my comments this morning by highlighting a recently announced product development milestone. Preclinical research shows that increasing tumor treating fields intensity enhances the cancer cell killing effect. The practical factor limiting field intensity in daily use is heat generation. We believe our next-generation arrays have the potential to mitigate the skin heating issue. Our research shows our next-generation arrays can deliver a higher, more consistent tumor-treating field intensity to the region of a patient's tumor. Our next-generation arrays are also designed to be more comfortable and provide greater range of motion. I am incredibly excited about this product development milestone as our next generation arrays have the potential to improve our therapy and the lives of patients and could be another lever for increasing penetration. We are working with regulatory authorities in anticipation of a limited release in select EU markets later this year. NovoCure is in the privileged position to have large organic opportunities to extend the reach of the tumor treating fields cancer therapy platform into new cancer indications and new geographies. We can further improve our therapy platform through product engineering. And our commercial business is fueling our many growth and product improvement initiatives. The durability of our core revenue streams allows our teams to focus on our strategic priorities, all with the ultimate goal to extend survivals in some of the most aggressive cancers. With that, I will now pass the call over to Asas to discuss our clinical updates from the quarter. Asas?