NovoCure Limited

Thank you for standing by. Welcome to the Novacure Q2 2023 earnings conference 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 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Ingrid Goldberg. Please go ahead.

Good morning, everyone. Thank you for joining us to review NovoCure's second quarter 2023 performance. I'm on the phone this morning with 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. For your reference, slides accompanying this earnings release can be found on our website, www.novacure.com, on our investor relations page under quarterly reports. 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, and are 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 attributable to 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 8-K filed with the SEC today. These materials can also be accessed from the 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. At NovoCure, our mission is to extend survival in some of the most aggressive forms of cancer through the development and commercialization of tumor treating fields. Since our founding, our commercial efforts have focused on treating patients with polioblastoma. The second quarter marked the beginning of a transformational period for NovoCure as we moved beyond the brain with the presentation of data from our first randomized phase three trial in the torso. On today's call, we will begin with a discussion of the LUNAR trial and other upcoming clinical catalysts, followed by a review of our commercial and financial performance in the quarter. In June, we took a meaningful step toward bringing tumor-treating field therapy to patients with high unmet need in lung cancer. At the American Society of Clinical Oncology annual meeting, Dr. Tiziana Leal of Emory University presented the results of the Phase III LUNAR clinical trial. The LUNAR trial studied the use of TT field therapy together with standard of care therapies for the treatment of stage 4 metastatic non-small cell lung cancer following platinum failure. The LUNAR trial met its primary endpoint, exhibiting a statistically significant improvement in overall survival from 9.9 months to 13.2 months for patients treated with TT field and standard of care therapies. compared to treatment with standard of care therapies alone. The clinically meaningful three-month survival improvement was achieved without increased systemic toxicity. In addition to meeting its primary survival endpoint, Lunar also met a key secondary endpoint demonstrating 18.5-month median overall survival for patients treated with tpFields and immune checkpoint inhibitors. This compares to a 10.8-month overall survival for patients treated with immune checkpoint inhibitors alone. I want to highlight and directly address the most frequent questions we've received from investors regarding the lunar trial results. Globally, TPS data was collected for 55% of patients enrolled in lunar and was balanced across the four cohorts. and was consistent with expected wild-type expression. In the U.S., TPS expression was measured for 83% of lunar enrollees and was balanced across the cohorts and was consistent with expected wild-type expression. The Kaplan-Meier curves for patients with measured TPS scores are nearly identical to the Kaplan-Meier curves for patients without measured TPS scores. underlines the potency of the survival data, regardless of PD-L1 status. We've also fielded questions regarding the difference between the effect size in overall survival and progression-free survival. This observed difference is not uncommon in trials studying immune checkpoint inhibitors and is in line with the results from a number of the leading immune checkpoint inhibitor trials in this setting. Overall survival is generally considered the gold standard endpoint in oncology. Finally, I would like to address the clinical applicability of the lunar results. One of the most exciting and rewarding aspects of dedicating one's career to extending the lives of cancer patients is witnessing the improvements and outcomes with evolving standards of care. While we have seen a shift in the first-line treatment for patients with metastatic non-small cell lung cancer, to immune checkpoint inhibitors, there remains an immense unmet need for effective low toxicity treatment options in the second line. There are few differentiated therapeutic options for second line treatment of stage four non-small cell lung cancer. The most recent meaningful survival breakthrough occurred over seven years ago when pembrolizumab was introduced. Since then, There have been several clinical trials evaluating the efficacy of other immune checkpoint inhibitors, but none of these trials have meaningfully moved the needle further. LUNR is the first phase three clinical trial in over seven years to show a clinically meaningful extension in overall survival in second line treatment of stage four non-small cell lung cancer. We are pleased with the clinical outcome of the lunar study and believe TT Fields will provide a much needed new treatment option for patients and thoracic oncologists in need of therapies that materially extend the overall survival without adding systemic toxicity. We are confident TT Fields therapy has a place in the current and future standards of care for second line treatment of stage four non-small cell lung cancer. We are pleased to announce that the lunar study results have been accepted to a high-impact journal, and we are now awaiting publication. Further, our regulatory team recently completed the lunar submission for CE-MARC. Our next step is to finalize our FDA PMA submission later this year. We plan to pursue a label consistent with the primary endpoint of the trial, PT fields together with standard therapies for second-line treatment of stage 4 non-small-cell lung cancer. To supplement the lunar results presented at ASCO, we're conducting additional analyses, which will further elucidate many key aspects of the trial. These analyses will include in- and out-of-field progression patterns, and patient survival as a function of usage and TPS score. Additional trial insights will further arm physicians with key data when evaluating the best opportunities to leverage RTT field therapy once approved. We expect to present these analyses before year end. Insights gained from the LUNAR trial will serve as the foundation for the next large randomized clinical trial studying TT fields in non-small cell lung cancer. As announced at ASCO, our next trials will explore the use of TT fields in earlier lines of therapy and in new therapeutic concomitant regimes. Specifically, I would like to highlight the Phase III LUNAR II trial, which will study the first-line use of TT fields concomitant with pembrolizumab and platinum-based chemotherapy for patients with metastatic non-small cell lung cancer. The FDA approved the IDE for LUNAR2, and we are currently preparing sites for initiation. LUNAR2 will be a randomized global trial designed to enroll 734 patients with a 21-month follow-up period after the last patient enrolled. Primary endpoints will be overall survival and progression-free survival. The LUNAR-2 trial is an important next step in our lung cancer program, and we look forward to providing updates in the coming quarters as we work to bring tumor-treating field therapies to patients in need. With that, I will turn the call over to Asaf to discuss other clinical updates, as well as our commercial performance in the second quarter.