NovoCure Limited

Good day, ladies and gentlemen. Thank you for standing by. Welcome to the NovoCure second quarter 2021 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 this session, you will need to press star 1 on your telephone. Please be advised that today's conference may be recorded. If you require any further assistance, please press star then 0. I would now like to hand the conference over to one of your speakers today, Ingrid Goldberg. Please go ahead.

Good morning, everyone, and thank you for joining us to review Novacure's second quarter 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 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 second quarter 2021 financial results. located in the Events section on our Investor Relations page. Before we start, I would like to remind everyone 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 statements except as required by law. Following our prepared remarks today, we will open the line for your questions. Financials for the three and six months ended June 30th, 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 in our Form 8K filed with the SEC today. These materials can also be accessed from our investor relations page of our website. With that, I will now turn the call over to Bill Doyle.

Thank you, Ingrid, and good morning, everyone. At NovoCure, we are singularly focused on our mission to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our platform therapy tumor treating fields. This quarter serves as another proof point that our commercial GBM business is providing the financial strength to aggressively invest in innovation to fuel the future growth of our company. In the second quarter, we generated $134 million in net revenues, representing 15% growth year over year. We have treated more than 20,000 patients to date. We have four Phase III pivotal trials, multiple ongoing and planned Phase II pilot trials, over 180 oncology patents issued and pending worldwide, and nearly $900 million in cash on hand. Operational and financial strength provides Novacure the flexibility to pursue growth initiatives across the organization. We believe our investments in commercial, clinical, and product development capabilities are instrumental to ensure organizational readiness as we strive to unlock the long-term value of the tumor treating fields platform. In today's call, we will first discuss the established position and multiple levers for expansion of our core GBM business. We will then turn to our recent clinical development progress, specifically within our thoracic and abdominal programs. And finally, we will address the financial power and flexibility afforded by the consistency and sustainability of our business. I will begin with our global phase four Trident trial in newly diagnosed GBMs. Trident is designed to test the benefit of moving tumor-treating fields therapy earlier in the GBM treatment paradigm. Today, GBM patients typically follow the protocol established by our successful EF14 clinical trial. Maximal debulking surgery is followed by chemoradiation. After chemoradiation, tumor-treating fields therapy is initiated concomitant with chemotherapy. Trident builds on preclinical research that showed tumor-treating fields increased sensitivity to radiation therapy and inhibited DNA damage repair. The randomized Trident trial compares initiating tumor-treating fields with chemoradiation versus initiating tumor-treating fields with chemotherapy following chemoradiation. Trident's objective is to extend survival by increasing the impact of chemoradiation and provide evidence of the benefit of initiating tumor-treating fields earlier in the patient's treatment journey. Trident is one of the largest GBM clinical studies initiated in our industry to date and underlines our commitment to the GBM community, our focus on increased engagement with research institutions, and our determination to further explore the optimal application of tumor-treating fields platforms. As of the end of the second quarter, we had 45 actively recruiting sites across the United States and EMEA. This quarter, we are also announcing an update to the Optune label for the treatment of GBM to include our EF-19 post-approval trial data. The EF-19 data confirmed the effectiveness and safety of Optune as monotherapy in recurrent GBM in a real-world setting and the label update strengthens Optune's clinical profile in GBM. Continuing to explore new opportunities within GBM, this quarter we launched a clinical collaboration with GT Medical Technologies to study the combination of tumor-treating fields and GT Medical's gamma-tylbrachytherapy. We plan to conduct a Phase II pilot study in patients with recurrent GBM to test the safety and effectiveness of neoadjuvant tumor-treating fields followed by resection and implantation of GT Medical's gamma-tylbrachytherapy and adjuvant tumor-treating fields. The opportunity here is twofold. First, this trial design will provide an opportunity to further study the radiosensitizing effect of tumor-treating fields in solid tumor cancers. Second, this is an opportunity to further engage with oncologists at leading academic centers regarding the potential efficacy of tumor treating fields together with other cancer therapies. In addition to our efforts to expand the eligible patient population through ongoing clinical research in GBM, we view the opportunity for geographic expansion as a key driver of future growth. We continue to strategically invest to enhance our market access capabilities. We believe these investments will enable us to successfully target optimal markets for opt-in identify the most appropriate access pathways, and successfully garner reimbursement in a timely manner. We have continued to negotiate with French health authorities to obtain national reimbursement there. This month, we received a positive assessment of Optum, earning an ASA3 rating. An ASA3 rating enables our team to move forward in the reimbursement negotiation process with the ultimate goal of achieving national reimbursement in France. Beyond France, we are actively evaluating numerous additional markets across Europe and the Asia-Pacific region where Optum can be made available to more patients. We believe there remains a multitude of opportunities to expand the use of Optum for the treatment of GBM. We will continue to evaluate label expansion, new clinical combination, collaborations, and new geographic expansion opportunities in service of our patient-forward mission to extend survival in some of the most aggressive forms of cancer. I will now turn the call over to Asaf to discuss our recent clinical updates.