NovoCure Limited

Good day and thank you for standing by. Welcome to the NoviCore Q3 2024 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 11 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.

Ingrid Goldberg Good morning, and thank you for joining us to review Novocare's third quarter 2024 performance. I am 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 will be available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.novacare.com, on the 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 8K 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 survivals in some of the most aggressive forms of cancer. Our efforts have focused largely on glioblastoma, but with the recent approval of OptumLua for non-small cell lung cancer, we are launching our next large indication. Launching tumor treating fields therapy in non-small cell lung cancer is an important achievement for Novacure. We are eager to bring a new and urgently needed therapeutic option to patients in need. This morning, We will begin with a discussion of our non-small cell lung cancer approval and launch plans, followed by a GBM business review, clinical pipeline update, and review of Novacure's third quarter financial performance. Two weeks ago, the FDA approved our PMA for OptumLua to treat post-platinum metastatic non-small cell lung cancer together with either an immune checkpoint inhibitor or dosetaxel. As you know, TT Field therapy is already approved to treat glioblastoma and mesothelioma, rare forms of brain and thoracic cancer. Our approval to treat non-small cell lung cancer means our innovative therapy will be an option for a large and growing patient population with an urgent and unmet need for effective therapies in the second line. For months, we've been preparing for this launch. The lung team was hired over the summer and has undergone extensive scientific training. We have had a substantial presence at oncology congresses around the world, including ELCC, ASCO, WCLC, and ESMO, providing an opportunity for physicians to learn about TT Fields therapy. We have had numerous advisory boards to ensure we fully understand the physician and patient needs. Our marketing team is prepared with a suite of resources for providers, care teams, patients, and caregivers. Physician and patient-focused websites were launched the day after approval, and our sales team was fully trained and in the field the following Monday. We are pleased to report that our first round of physicians have completed certification, and we received our first lung prescription shortly after approval. Our launch is well underway. We are also preparing for launch in Germany and Japan in anticipation of regulatory approvals. As noted last quarter, the new MDR process has lengthened regulatory review timelines in Europe. While the review process has taken longer than originally projected, we remain hopeful for a final decision in the coming months. In Japan, we have submitted our application to the PMDA and productive conversations are ongoing. We will be launch ready upon approval in both of these important markets. I am incredibly proud of the efforts of our team to bring TT Fields therapy to non-small cell lung cancer patients. So many people across NovoCure have contributed to this milestone. Also, we would not have been able to celebrate this moment today without the partnership and commitment of our patients, their families and caregivers, and the physicians, researchers, and healthcare professionals that have taken part in our clinical trials. Thank you all. This is an important achievement for patients. As we prepare for a new chapter at Novacure, we are pleased to implement planned changes to our executive team that will position Novacure for long-term success. Last month, we announced the retirement at the end of this year of our CEO, Asaf Danziger. Asaf has been with Novacure for 22 years. and has shepherded our company through our successful clinical trials, regulatory approvals, engineering advances, and the launch of our successful GBM business. Under Asaf's leadership, we have grown from a small team in Israel to an international company of over 1,400 employees. We knew the day would come when Asaf would choose to retire, and to prepare, we have been cultivating a strong bench of leaders. When the board began the process to identify a soft successor, our goal was to find a candidate with substantial institutional knowledge, experience managing and expanding global organization, and a deep understanding of our clinical and commercial opportunities. Ashley Cordova embodies all of these characteristics. Ashley has been integral to scaling Novacure's global operations and infrastructure since joining the company in 2014. Her commitment to our patients and strategic vision are exceptional, as is her record of accomplishment as our CFO. We are delighted Ashley has accepted the challenge and confident she is the right choice to drive Novocure's next stage of growth. This morning, we also announced Christoph Brackman has joined Novocure as our next CFO, replacing Ashley in this role. Christoph joins Novocure this week and will assume the CFO position on January 1st. Christoph was most recently the Senior Vice President of Finance at Moderna, and he brings a wealth of experience in the biotechnology and pharmaceutical industries. Christoph was instrumental to Moderna's scale-up during the COVID pandemic. His external perspective will be an important addition to our executive team. Finally, in October, Mukund Parivashu took over as our COO. following the retirement of Wilco Grunhausen. With these additions to our executive leadership, the board and I believe we have the team in place that will lead NovoCure to the next levels of growth. Before I pass the call over to Ashley, I would like to extend my personal thanks to Asaf for his 22 years of dedication to NovoCure. Asaf and I were young men when we embarked on the journey to bring tumor treating fields therapy to patients And I know we would not have succeeded and Novacure would not exist today without Asah. Ashley.