NovoCure Limited

Good day, and thank you for standing by. Welcome to the Novocure first quarter 2021 in-news conference. 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 that session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Adam Taney.

Good morning, everyone, and thank you for joining us to review Novacure's first 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 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 the first quarter 2021 financial results. located in the events section of our investor relations page. Before we start, I would like to remind you that our discussion 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. Following our prepared remarks today, we will open the line for questions. Financials for the three months ended March 31, 2021 are available in our press release and in our 10Q, both of which we released earlier this morning. Where appropriate, we will 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 on our Form 8K filed at the SEC today. These materials can be accessed from our investor relations page of our website, www.novacure.com. With that, I will now turn the call over to Bill Doyle.

Thank you, Adam, and good morning, everyone. We are pleased to share our first quarter results today. Over the last several months, we made progress across our clinical development programs to determine tumor treating fields optimal use. Our established commercial business continued to generate the financial strength needed to invest in our future. As we look ahead, we believe multiple levers remain to unlock the full potential of the tumor treating fields platform. Our commercial business generated $135 million in net revenue in the first quarter of 2021. And we invested $46 million in research and development programs intended to fuel future growth. We recently reached exciting milestones in several clinical programs and continue to actively enroll patients in seven trials across six solid tumor cancers. Almost 20,000 patients have been treated with tumor treating fields. As we reflect on our progress to date and the road ahead, we believe we are just beginning. Earlier this month, we announced that the pre-specified interim analysis for our phase three pivotal lunar trial in non-small cell lung cancer concluded with a favorable recommendation from the Independent Data Monitoring Committee, or DMC, to continue accrual, successfully clearing the futility hurdle. There was no evidence of clinically relevant increased toxicity other than expected generally low-grade skin toxicity in the experimental arm. The DMC went on to say that continued accrual to 534 patients as proposed in the original protocol, given the current rate of accrual and the interim data presented, is likely unnecessary and possibly unethical for patients randomized to control. For this reason, the DMC recommended an adjustment of accrual to approximately 276 patients with a 12-month follow-up following the enrollment of the last patient. The DMC believes this amended protocol would provide adequate data regarding toxicity and efficacy, providing sufficient overall power, as well as potentially providing important information regarding efficacy within the treatment subgroups. LUNR is a multinational trial with sites in the United States, Western and Eastern Europe, and Israel, testing the safety and effectiveness of immune checkpoint inhibitors or docetaxel together with tumor treating fields versus immune checkpoint inhibitors or docetaxel alone for patients with stage four non-small cell lung cancer who progressed during or after platinum-based therapy. Advanced or metastatic non-small cell lung cancer is commonly treated with platinum-based therapy in the first line, and the LUNAR trial was designed to generate data that contemplate multiple clinically meaningful outcomes for non-small cell lung cancer patients following platinum failure. Though Novacure is fully blinded to the trial data and expects to remain blinded through completion of the trial, the DMC had full access to the trial data from both arms of the study when making their recommendations. We are very excited by the DMC's recommendations and believe the potential to power all endpoints with the reduced sample size and follow-up duration is an indication of the maturity of the trial data and strength of the signal generated to date. We have submitted an IDE supplement to the FDA which incorporates the recommended protocol adjustments and are awaiting the agency's final determination following a 30-day review period. We are also engaging with our trial investigators to identify opportunities to accelerate enrollment. If approved, the new protocol could accelerate our trial completion by more than a year. The DMC recommendation represents an important milestone in our lung cancer development program and in our efforts to better understand the potential benefits of tumor treating fields mechanism of action when used together with immunotherapies. Greek clinical research has shown that tumor-treating fields can induce immunogenic cell death. Multiple markers of cellular stress, specifically high-mobility group B1 secretion and calreticulin exposure increase significantly in the presence of tumor-treating fields. Cells treated with tumor-treating fields also exhibit autophagy-dependent reductions in adenosine triphosphate levels. Our in vitro observations have been reproduced in animal models. Tumor treating fields together with anti-PD-1 therapy enhanced anti-tumor immunity and resulted in increased tumor control in vivo. We have observed a significantly higher frequency of macrophages and dendritic cells in tumors in mice treated with tumor treating fields and anti-PD-1 therapies. Compared to tumors in mice treated with tumor treating fields alone, anti-PD-1 therapy alone and in untreated control mice. The PD-L1 expression levels increased in tumors treated with tumor-treating fields, suggesting an elevated inflammatory response. We are eager to translate this preclinical experience to clinical data. In addition to our lunar trial, we recently received IDE approval to initiate our Phase 2 pilot Keynote B36 trial conducted in collaboration with MSD, a trademark of Merck. Keynote B36 is designed to study tumor-treating fields together with Pembrolizumab in first-line non-small-cell lung cancer. We believe data generated from the Lunar and Keynote B36 trials will provide valuable insights into the potential benefits of treating cancer with tumor treating fields therapy concomitant with immunotherapy. Combination therapy is a cornerstone of cancer care, and we are developing tumor treating fields as a limited toxicity backbone therapy upon which other standard of care and emerging cancer treatments can be added. In addition to immunotherapy, we continue to explore the potential benefits of using tumor treating fields together with radiation therapy, and certain chemotherapies. We recently concluded our HEPA-NOVA trial investigating tumor-treating fields together with serapinib, a kinase inhibitor, in 25 patients with advanced liver cancer. We have submitted an abstract for presentation at an upcoming medical conference in late June and look forward to discussing the full data set with clinicians, investigators, and investors in the future. I will now turn the call over to Asaf to discuss our commercial results for the quarter.