NovoCure Limited Ordinary Shares 2026 Q3 Earnings Call

Please go ahead. Morning, and thank you for joining us to review NovoCure's third quarter 2026 performance.

I am joined on the phone today by our Executive Chairman, Bill Doyle, CEO, Frank Leonard, Chief Innovation and Medical Officer, Uri Weinberg, and CFO, Christoph Brackmann. For your reference, slides accompanying this earnings release can be found on our website, www.novocure.com, on the investor relations page under quarterly results. 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 and 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. We do not provide forward-looking guidance for adjusted EBITDA on a GAAP basis due to the inability to predict share-based compensation expenses contained in the reconciled GAAP measure net income without reasonable efforts. Reconciliations of non-GAAP to GAAP financial measures are included in our press release, earnings slides, and in our Form 10-Q filed with the SEC today. These materials can be accessed from the investor relations page of our website. Following our prepared remarks, we will open the line for questions.

I will now turn the call over to our Executive Chairman, Bill Doyle.

Thank you, Adam. This morning, NovoCure reported results for the third quarter of 2026. This quarter was marked by solid execution, with continued momentum in our Optune Gio business and our promising launch of Optune Lua in Japan. We reached a record number of active patients on therapy, generated record high quarterly net revenue, and made strong progress on our path to profitability. We experienced headwinds in our Optune Pax launch this quarter, but remain committed to establishing TTFields therapy in the evolving PDAC standard of care. As we enter the final months of the year, we are on track to achieve our 2026 goals, and we believe we are well positioned to drive this positive momentum into 2027. I will begin this morning with a review of our Optune Gio and Optune Mya programs.

Frank will provide an update on Optune Pax and Optune Lua, and Christoph will conclude our prepared remarks with a review of our third quarter financial results and updated guidance. We will then open the line for questions. Q3 was another strong quarter for our Optune Gio business. We finished the period with 4,729 GBM patients on therapy, an 11% increase year-over-year, and our highest GBM active patient count to date. A notable feature of this growth cycle is the mix of contributions from both new and established markets. We continue to believe many more patients can benefit from Optune Gio, and we are determined to find the avenues to reach them.

Each of our active markets has opportunities to increase adoption in GBM, and our country-level teams are focused on improving outreach and targeting to connect with physicians and patients at the optimal points in their treatment journeys. Optune Gio is a standard of care for newly diagnosed GBM, established on the foundation of the best-in-class clinical data for overall survival. We are working to extend survival further. Our phase III KEYNOTE-D58 clinical trial is evaluating adding the immunotherapy pembrolizumab to Optune Gio and low dose chemotherapy in diagnosed glioblastoma. We have been pleased with the strong interest in D58 since launch, as physicians are eager to see whether concomitant use of TTFields and immunotherapy can improve survival in GBM further. D58 remains on track to complete enrollment by year end, and we look forward to sharing more information from this trial in the periods ahead.

Turning to Optune Mya, our PMA application for the treatment of brain metastases from non-small cell lung cancer is under review with the FDA. As a reminder, this application is based on the data from the phase III METIS trial, which showed a doubling in time to intracranial progression in patients on the TTF arm compared to control. We continue to expect a final decision on our PMA application by year end, with a potential launch in early 2027. As with our other launches, we expect to establish reimbursement within 2 years of launch. NovoCure continues to grow and evolve. We have reignited growth in our core GBM business and launched Optune Lua and Pax in multiple countries, with Mya expected to follow. We have established the infrastructure to service larger patient populations and have initiated structural changes to accelerate our transition to profitability.

I'll now pass the call to Frank to discuss the ongoing launches of Optune Pax and Lua.

Thank you, Bill. We believe that we have multiple drivers of long-term growth, including increasing adoption of Optune Gio, successfully launching new indications like Optune Pax and Mya, and pursuing opportunistic launches such as the Optune Lua launch in Japan. We are 2 and a half quarters into our launch of Optune Pax, and we finished the third quarter with 276 active patients on therapy and generated $3.7 million in net revenue. We have seen momentum slow in the U.S. due to the introduction of daraxonrasib. Our ability to access practices to detail Optune Pax is significantly limited at this time. We acknowledge the challenges in the Optune Pax launch, and we will continue to evolve our tactics to ensure we maintain our share of voice in our approved indication, which is different than the approved indication for daraxonrasib.

We will also continue to monitor the details of the daraxonrasib launch and invest appropriately in relation to the market realities. We look forward to the upcoming annual update of the NCCN guidelines for the treatment of pancreatic cancer, and we'll update our marketing materials accordingly. Most importantly, we will work closely with our physician collaborators to establish the best next set of clinical trials to establish TTFields more firmly as a standard of care for PDAC. We are specifically eager to generate data focused on concomitant use of TTFields and KRAS inhibitors. The initial step in this effort will be through two small safety and feasibility trials. The PANOVA-5 trial will explore the concomitant use of Optune Pax, gemcitabine, nab-paclitaxel, and Verastem's KRAS G12D inhibitor, VS-7375, in our approved locally advanced setting.

We are excited to collaborate with Verastem in this effort and expect to initiate this study in the first half of 2027. The PANOVA-6 trial will explore concomitant use of Optune Pax and daraxonrasib in the metastatic setting, which we also expect to initiate in the first half of 2027. Moving to Optune Lua, we continue to see momentum in our launch in Japan. We finished the quarter with 255 Optune Lua active patients and $8 million net revenue globally, with 110 active patients and $4 million in net revenue contributed by Japan. Second-line use of immune checkpoint inhibitors is standard of care in Japan, which overlaps well with our label and the strongest outcomes from the LUNAR trial data. In addition to the promising commercial landscape, the negotiated monthly price for Optune Lua in Japan is approximately in line with our global price for Optune Gio.

Optune Pax was also approved by Japanese regulators earlier this year, with reimbursement likely in the first half of 2027. Together with our growing Optune Gio business, we expect Japan will eventually be our second-largest market behind the U.S. As Bill said earlier, we focused in recent years on diversifying and expanding our growth drivers. We are beginning to see those drivers contribute, specifically in our continued Optune Gio growth and Optune Lua launch in Japan. We expect Optune Pax to return to growth in the coming quarters, and with these drivers in place, as well as enhanced controls on operating expenses. We believe we are well-positioned to make material strides forward in our path to profitability next year. I will now pass the call over to Christoph to review our third quarter financials.