Ashley Cordova
Analyst · Leerink Partners. Your line is now open
Thank you, Bill. I am honored to step into the role of Chief Executive Officer at this pivotal moment in Novocure's history. Our mission has never felt more urgent as we expand our reach to patients facing some of the most challenging followed tumors with significant unmet need. To provide more detail on Bill's opening remarks, our first objective in 2024 was to grow our GBM business. GBM remains the foundation of our company, providing financial strength to invest in our pipeline and execute multiple launches. In 2024, we grew active patients by 10%, surpassing 4,000 active patients on therapy for the first time. Our growth was driven by strong performance in multiple markets, including France, now our third-largest market, and Germany and Japan. Improved US approval rates contributed to 2024 top line growth as higher US net pricing complemented the increase in global active patients. Our second goal in 2024 was to launch our newest indication, Optune Lua, in second-line non-call lung cancer. Entering the year, we submitted a PMA application to the FDA based on the LUNAR Phase 3 clinical trial data and began the process of building a thoracic sales force in anticipation of FDA approval. On October 15, we received FDA approval with a broad label, including both toplitaxel and physician's choice of immune checkpoint inhibitor as concomitant therapy option. Our Optune Lua sales team was immediately in the field. And between approval and year-end, we received 52 prescriptions, and we finished the year with 20 active patients on therapy. We are pleased with these initial results and the early feedback from patients and physicians is promising. Patients are eager to access a new unique therapy in non-small cell lung cancer. And we are seeing interest from thoracic oncologists, medical oncologists, and radiation oncologists in both concomitant chemotherapy and immunotherapy option. While early demand is promising, we remind investors that we are currently in the process of securing reimbursement and these negotiations take time. We expect payer coverage milestones in 2025 with material revenue ramping in 2026 as coverage expands. Our final 2024 objective was to deliver on the promise of our clinical pipeline in indications with extremely high unmet need. In March, we announced successful top line results from our Phase 3 METIS trial investigating tumor treating fields therapy for the treatment of brain metastases from non-cell lung cancer following stereotactic radiosurgery. METIS met its primary end point. Patients treated with tumor treating fields therapy exhibited 21.9 months median time to intracranial progression compared to 11.3 months for patients treated with supportive care. In December, we announced successful top line results from our Phase 3 PANOVA-3 trial, investigating tumor treating field therapy together with gemcitabine and nabpaclitaxel for the treatment of unresectable locally-advanced pancreatic cancer. PANOVA-3 also met its primary end point as patients randomized to receive tumor treating fields therapy demonstrated a median overall survival of 16.2 months compared to 14.2 months in the control arm. PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant survival benefit in this notoriously difficult-to-treat patient population. Early reactions from key pancreatic physicians have been very supportive, and we look forward to presenting the full data set at a medical conference later this year. METIS and PANOVA-3 represent major opportunities to expand our market reach as each serves patient populations with extremely high unmet need. Brain metastases from non-small cell lung cancer and locally-advanced pancreatic cancer, together with our recent lung cancer launch, have the potential to increase our eligible patient population to 7x our GBM opportunity. Beyond these near-term catalysts, we continue to invest in our pipeline in GBM, lung, and pancreatic cancers. With ongoing trials like TRIDENT, LUNAR-2, KEYNOTE-D58, and PANOVA-4, we see additional label expansion potential over the next few years. To touch on these trials quickly, our Phase 3 TRIDENT trial in GBM is studying the addition of tumor treating field therapy to chemoradiation rather than starting after chemoradiation, potentially increasing the duration and efficacy benefit of tumor treating fields. TRIDENT is fully enrolled and we expect data in the first half of 2026. Our other pipeline trials are studying the concomitant use of tumor treating field therapy and immune checkpoint inhibitors, a regimen that showed a missed promise in the LUNAR data set. These trials include our Phase 3 LUNAR-2, our Phase 2 LUNAR-4, our Phase 3 KEYNOTE-D58, and our Phase 2 PANOVA-4 trial. The first three trials are open and enrolling. PANOVA-4 is fully enrolled and we expect data in the first half of 2026. These trials represent the next wave of innovation in NovoCure’s clinical pipeline with the potential to significantly expand the use of tumor treating fields therapy and the cancers where we have already established clinical benefit. Beyond the progress made advancing our clinical pipeline, we achieved key milestones in our product development program with the approval of our HFE arrays in the US and Japan. The HFE arrays are thinner, lighter and more flexible than our legacy arrays. We are rolling out the HFE arrays in all major markets, and feedback has been very encouraging. We believe the rollout of our next-generation HFE array is an important step in improving patients' usage, reducing barriers to adoption and ultimately expanding the market for tumor treating field therapy. As we reflect on the progress achieved in 2024, the NovoCure story has substantially evolved. With the binary clinical events of prior years behind us, we are now focused on execution. 2025 is off to a strong start, and we expect to reach multiple important milestones this year. In lung cancer, we will continue to provide insights into the progress of our Optune Lua launch. We will pursue clinical guidelines and reimbursement in US and regulatory approvals in Europe and Japan. In brain mets, we expect to publish the METIS trial results and are engaged with the FDA in pre-submission discussions in anticipation of submitting a PMA application later this year. In pancreatic cancer, we expect to present the PANOVA data at an upcoming medical conference, followed by publication in a peer-reviewed journal. And again, we are engaged with the FDA and pre-submission discussion in anticipation of submitting a PMA application later this year. With FDA breakthrough designation for both brain mets and pancreatic cancer, we have the potential for launches in both indications in 2026. 2025 marks the beginning of a new era in NovoCure's journey, as we evolve from one indication in GBM to a multi-indication platform therapy company. The vision is clear. We are working to extend survival for as many patients as possible as we build on an incredibly strong foundation. With that, I would like to turn the call over to our newest executive colleague, Christoph Brackmann.