NovoCure Limited

Good day and thank you for standing by. Welcome to the Novacure Q2 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.

Good morning, and thank you for joining us to review Novocare's second quarter 2024 performance. I'm joined this morning by our Executive Chairman, Bill Doyle, our CEO, Asaf Donziger, and our CFO, Ashley Cordova. Other members of the 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 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 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-GAAP to GAAP financial measures are included in our press release, earnings slides, and in our Form 8-K file with the SEC today. These materials can also be accessed from the Investor Relations page of our website. Following our prepared remarks today, we'll 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. Our mission at NovoCure is to extend survival in some of the most aggressive forms of cancer, through the development and commercialization of our innovative therapy tumor treating fields. We have built a strong foundation treating glioblastoma, and with an anticipated approval to treat second line non-small cell lung cancer, we are on the threshold of helping many more patients in need. As we approach this year's milestone, the urgency of our mission is even greater for the entire NovoCure team. Entering 2024, we identified three key objectives which would best position us for success this year and beyond. One, to grow our commercial business in glioblastoma. Two, to launch TT Field therapy in non-small cell lung cancer. And three, to deliver on the promise of our clinical and product development pipeline. These objectives are ingrained in our business unit and have been rallying points for our global teams. I am pleased to share that we are making significant progress on all three. And with the focus and dedication of the entire Novocure team, we believe we can deliver on all three in 2024. This morning, we will review our progress on each objective, review our financial performance, and then open the line for questions. We ended the second quarter with 3,963 active patients on therapy. our highest number of active patients since commencing commercial operations. Our French GBM launch, now in its fifth quarter, continues to be a tailwind. France serves as a blueprint for a successful launch employing our new synchronized commercial structure, a blueprint we will leverage in future expansion across the big five EU markets. Real-world evidence of the benefits of TTP field therapy is a key resource for engaging with prescribers. In June at ASCO, Dr. Olivier Barr of the General Hospital Aschaffenburg-Allenau presented top-line data from the TIGER trial. TIGER examined TTP field therapy in the routine clinical care of newly diagnosed GBM patients in Germany. TIGER is the largest prospective non-interventional TTP fields trial completed to date. Dr. Barr reported a median overall survival of 19.6 months. and median progression-free survival of 10.2 months, corroborating the leading survival outcomes observed in our Phase III EF14 trial. Last month, in the Journal of Neuro-Oncology, Dr. Mergalla of the Mayo Clinic published updated findings from a post-marketing safety analysis of over 25,000 TT Fields patients. Dr. Mergalla's analysis confirmed that TT field therapy was well tolerated, and that no signs of additive systemic toxicity were detected in the patient population, corroborating the safety findings of the EF14 trial. In April, in the journal BMC Cancer, Dr. Kunzecker of Northwestern published a qualitative review of key factors driving patient adoption of Optune Geo for the treatment of GBM. Dr. Kumthakar's team found that the two most influential drivers for adoption are knowledge of Optum's proven survival benefits and the treating physician's opinion. Real-world evidence from trials like TIGER and Dr. Murghala and Kumthakar's analyses are important additions to the ever-growing body of studies supporting OptumGEO for the treatment of GBM. And they underline our commitment to generate and share data with physicians to support and broaden the adoption of Tiki Fields. We are also focused on product development to improve the patient experience. We have rolled out our next generation arrays in our key European markets, and patient feedback continues to be positive. We submitted a PMA supplement to the FDA in December and expect a decision from the FDA later this year. After approval, we will commence U.S. rollout. Our team is working on improvements to the digital experience for prescribers and patients with the goal of providing dashboards to streamline patient starts and optimize usage and persistence. We believe our fully aligned commercial approach supported by real-world evidence and digital innovation will help to drive strong commercial performance in the second half of the year. Our second key objective this year is the approval and launch of OptumLua for the treatment of metastatic non-small cell lung cancer. Regulatory submissions have been filed, and we are engaged with authorities in all of our major markets. As a reminder, prior to our May earnings report, we had recently completed our 100-day meeting with the FDA, with no indication that the PMA will be referred to a panel. To date, a panel has not been requested, and our expectations remain unchanged. We eagerly await the FDA's decision later this year. In Europe, we are waiting for CE mark approval. The new MDR process in Europe has lengthened timelines, and we continue to engage with new reviewers at TUV Rhineland, our EU-notified body. While the review process has taken longer than originally projected, our expected outcome has not changed, and we anticipate a final decision in the second half of 2024. Internally, our German and US lung teams are hired and are preparing to launch immediately following regulatory approval. We plan to treat patients in the US and Germany as soon as possible following approval, using a named patient reimbursement process with additional country launches expected next year. Non-small cell lung cancer represents the next major step forward in the Novacure story, and we are eager to pursue this opportunity. Asaf will now review our clinical progress in the quarter.