Q4 2025 Novocure Ltd Earnings Call
Speaker #2: Good day and thank you for standing by. Welcome to the Novocure fourth-quarter 2025 earnings call. At this time, all participants are on a listen-only mode.
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Speaker #2: I'd now like to hand the conference over to Adam Danney, Head of Investor Relations. Please go ahead.
Speaker #3: Good morning, and thank you for joining us to review NovaCure's fourth quarter and full year 2025 performance. I'm joined on the phone today with our Executive Chairman, Bill Doyle, CEO, Frank Leonard, and CFO, Christoph Brackmann, other members of our Executive Leadership Team will be available for Q&A.
Asaf Danziger: Good morning. Thank you for joining us to review Novocure's Q4 and full year 2025 performance. I'm joined on the phone today with our Executive Chairman, Bill Doyle, CEO, Frank Leonard, and CFO, Christoph Brackmann. 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 at www.novocure.com on the Investor Relations page under Quarterly Reports. Before we start, I would like to remind you that our discussions today during this conference call will include forward-looking statements. 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.
Asaf Danziger: Good morning. Thank you for joining us to review Novocure's Q4 and full year 2025 performance. I'm joined on the phone today with our Executive Chairman, Bill Doyle, CEO, Frank Leonard, and CFO, Christoph Brackmann. 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 at www.novocure.com on the Investor Relations page under Quarterly Reports. Before we start, I would like to remind you that our discussions today during this conference call will include forward-looking statements. 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.
Speaker #3: For your reference, slides accompanying this earnings release can be found on our website at www.novacure.com on the Investor Relations page under Quarterly Reports. Before we start, I would like to remind you that our discussions today during this conference call will include forward-looking statements and actual results could differ materially from those projected in these statements.
Speaker #3: 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.
Speaker #3: 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.
Asaf Danziger: 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. 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 of 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-K filed with the SEC today.
Asaf Danziger: 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. 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 of 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-K filed with the SEC today.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: Reconciliations of non-GAAP to GAAP financial measures are included in our press release, earnings slides, and in our Form 10-K filed with the SEC today.
Speaker #3: These materials can also be accessed from the Investor Relations page of our website. Following our prepared remarks this morning, we will open the line for your questions, and we'll now turn the call over to our Executive Chairman, Bill Doyle.
Asaf Danziger: These materials can also be accessed from the investor relations page of our website. Following our prepared remarks this morning, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.
Asaf Danziger: These materials can also be accessed from the investor relations page of our website. Following our prepared remarks this morning, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.
Speaker #4: Thank you, Adam. I'll begin this morning with a brief review of our 2025 accomplishments, and look ahead to 2026. Our CEO, Frank Leonard, will then discuss recent commercial updates and finally our CFO, Christoph Brackmann, will walk through our fourth-quarter financial performance and 2026 guidance before opening the line for questions.
William F. Doyle: Thank you, Adam. I'll begin this morning with a brief review of our 2025 accomplishments and look ahead to 2026. Our CEO, Frank Leonard, will then discuss recent commercial updates. Finally, our CFO, Christoph Brachmann, will walk through our Q4 financial performance and 2026 guidance before opening the line for questions. 2025 was a year of progress and change at Novocure. We generated a record $655 million in net revenues last year, an 8% increase from 2024. We presented final data from two large randomized trials in plenary sessions at major medical congresses, followed by publications in leading medical journals. We submitted PMA applications to the FDA for the use of TTFields therapy to treat pancreatic cancer and brain metastases from non-small cell lung cancer.
Bill Doyle: Thank you, Adam. I'll begin this morning with a brief review of our 2025 accomplishments and look ahead to 2026. Our CEO, Frank Leonard, will then discuss recent commercial updates. Finally, our CFO, Christoph Brachmann, will walk through our Q4 financial performance and 2026 guidance before opening the line for questions. 2025 was a year of progress and change at Novocure. We generated a record $655 million in net revenues last year, an 8% increase from 2024. We presented final data from two large randomized trials in plenary sessions at major medical congresses, followed by publications in leading medical journals. We submitted PMA applications to the FDA for the use of TTFields therapy to treat pancreatic cancer and brain metastases from non-small cell lung cancer.
Speaker #4: 2025 was a year of progress and change at NovaCure. We generated a record $655 million in net revenues last year, an 8% increase from 2024.
Speaker #4: We presented final data from two large randomized trials in plenary sessions at major medical congresses. Followed by publications in leading medical journals. We submitted PMA applications to the FDA for the use of TT Fields therapy to treat pancreatic cancer and brain metastases from non-small cell lung cancer.
Speaker #4: And we rolled out product enhancements designed to improve the TT Fields therapy experience for both patients and physicians. 2025 was a strong year of execution.
William F. Doyle: We rolled out product enhancements designed to improve the TTFields therapy experience for both patients and physicians. 2025 was a strong year of execution, setting the stage for a catalyst-rich 2026. We expect to reach a number of regulatory, clinical, and commercial milestones this year. The first milestone was reached earlier this month with the approval of Optune Pax for the treatment of locally advanced pancreatic cancer, and we have submitted regulatory filings for Optune Pax in Europe and Japan. We expect Optune Pax to be a significant contributor to our long-term growth and are eager to begin treating patients in the coming weeks. We also expect a decision from the FDA on our brain metastases PMA later this year. On the clinical front, we are on track for top-line readouts from both the PANOVA 4 and TRIDENT trials this year.
Bill Doyle: We rolled out product enhancements designed to improve the TTFields therapy experience for both patients and physicians. 2025 was a strong year of execution, setting the stage for a catalyst-rich 2026. We expect to reach a number of regulatory, clinical, and commercial milestones this year. The first milestone was reached earlier this month with the approval of Optune Pax for the treatment of locally advanced pancreatic cancer, and we have submitted regulatory filings for Optune Pax in Europe and Japan. We expect Optune Pax to be a significant contributor to our long-term growth and are eager to begin treating patients in the coming weeks. We also expect a decision from the FDA on our brain metastases PMA later this year. On the clinical front, we are on track for top-line readouts from both the PANOVA 4 and TRIDENT trials this year.
Speaker #4: Setting the stage for a catalyst-rich 2026. We expect to reach a number of regulatory, clinical, and commercial milestones this year. The first milestone was reached earlier this month with the approval of Optune PACs for the treatment of locally advanced pancreatic cancer.
Speaker #4: And we have submitted regulatory filings for Optune PACs in Europe and Japan. We expect Optune PACs to be a significant contributor to our long-term growth and are eager to begin treating patients in the coming weeks.
Speaker #4: We also expect a decision from the FDA on our brain metastases PMA later this year. On the clinical front, we are on track for top-line readouts from both the PANOVA-4 and TRIDENT trials this year.
Speaker #4: Panova 4 is a Phase II trial exploring the use of TT Fields at tezolizumab, a checkpoint inhibitor, and chemotherapy in metastatic pancreatic cancer. With top-line data anticipated next month.
William F. Doyle: PANOVA-3 is a phase two trial exploring the use of TTFields, atezolizumab, a checkpoint inhibitor, and chemotherapy in metastatic pancreatic cancer, with top-line data anticipated next month. TRIDENT is a phase three trial exploring earlier use of TTFields concomitant with radiation and temozolomide in newly diagnosed GBM, which we expect to read out in Q2. We are also on track to complete enrollment of our next phase three trial, KEYNOTE-D58, studying tumor treating fields, temozolomide, and the checkpoint inhibitor pembrolizumab in newly diagnosed GBM by year-end. Turning to our commercial portfolio, we anticipate a number of national or regional launches of our three products this year. This includes Optune Gio launches in Spain, Czechia, and the Canadian province of British Columbia, an Optune Lua launch in Japan, and Optune Pax launches in the US and Germany.
Bill Doyle: PANOVA-3 is a phase two trial exploring the use of TTFields, atezolizumab, a checkpoint inhibitor, and chemotherapy in metastatic pancreatic cancer, with top-line data anticipated next month. TRIDENT is a phase three trial exploring earlier use of TTFields concomitant with radiation and temozolomide in newly diagnosed GBM, which we expect to read out in Q2. We are also on track to complete enrollment of our next phase three trial, KEYNOTE-D58, studying tumor treating fields, temozolomide, and the checkpoint inhibitor pembrolizumab in newly diagnosed GBM by year-end. Turning to our commercial portfolio, we anticipate a number of national or regional launches of our three products this year. This includes Optune Gio launches in Spain, Czechia, and the Canadian province of British Columbia, an Optune Lua launch in Japan, and Optune Pax launches in the US and Germany.
Speaker #4: Trident is a Phase III trial exploring earlier use of TT Fields concomitant with radiation and temozolomide in newly diagnosed GBM. Which we expect to read out in Q2.
Speaker #4: We are also on track to complete enrollment of our next Phase III trial keynote D58 studying tumor temozolomide and the checkpoint inhibitor pembrolizumab in newly diagnosed GBM by year-end.
Speaker #4: Turning to our commercial portfolio, we anticipate a number of national or regional launches of our three products this year. This includes Optune GO launches in Spain, Czechia, and the Canadian province of British Columbia.
Speaker #4: And Optune LUA launch in Japan and Optune PAC launches in the US and Germany. Before I hand the call over to Frank, I would like to touch on one update from this morning's press release.
William F. Doyle: Before I hand the call over to Frank, I would like to touch on one update from this morning's press release. Dr. Nicolas Leupin, our Chief Medical Officer, resigned from the company effective 25 February. Following Nicolas's departure, we have decided to combine our scientific and clinical organizations to accelerate our R&D execution and shorten the cycle from scientific insight to clinical relevance. Dr. Uri Weinberg, our Chief Innovation Officer, will now also assume the role of Chief Medical Officer. Dr. Weinberg joined Novocure in 2008 and has been instrumental in establishing and leading a number of our scientific and research and development functions over the years. Uri is well qualified to take over this dual mandate. I would like to personally thank Nicolas for his contributions to Novocure and to congratulate Uri on his expanded role.
Bill Doyle: Before I hand the call over to Frank, I would like to touch on one update from this morning's press release. Dr. Nicolas Leupin, our Chief Medical Officer, resigned from the company effective 25 February. Following Nicolas's departure, we have decided to combine our scientific and clinical organizations to accelerate our R&D execution and shorten the cycle from scientific insight to clinical relevance. Dr. Uri Weinberg, our Chief Innovation Officer, will now also assume the role of Chief Medical Officer. Dr. Weinberg joined Novocure in 2008 and has been instrumental in establishing and leading a number of our scientific and research and development functions over the years. Uri is well qualified to take over this dual mandate. I would like to personally thank Nicolas for his contributions to Novocure and to congratulate Uri on his expanded role.
Speaker #4: Dr. Nicholas LePen, our Chief Medical Officer, resigned from the company effective February 25. Following Nicholas's departure, we have decided to combine our scientific and clinical organizations to accelerate our R&D execution and shorten the cycle from scientific insight to clinical relevance.
Speaker #4: Dr. Uri Weinberg, our Chief Innovation Officer, will now also assume the role of Chief Medical Officer. Dr. Weinberg joined Novocure in 2008 and has been instrumental in establishing and leading a number of our scientific and research and development functions over the years.
Speaker #4: Uri is well qualified to take over this dual mandate. I would like to personally thank Nicholas for his contributions to Novocure, and to congratulate Uri on his expanded role.
Speaker #4: With that, let me hand the call to Frank to walk through recent updates.
William F. Doyle: With that, let me hand the call to Frank to walk through recent updates.
Bill Doyle: With that, let me hand the call to Frank to walk through recent updates.
Speaker #5: Thank you, Bill. And good morning. I'm excited to speak to you in my new role as CEO and at a time when NovaCure is evolving into a multi-indication platform company.
Frank Leonard: Thank you, Bill, and good morning. I'm excited to speak to you in my new role as CEO and at a time when Novocure is evolving into a multi-indication platform company. 2025 was our most successful commercial year to date, and we expect to carry this positive momentum into 2026. Our GBM business remains core to our commercial operations. In 2025, we saw substantial active patient growth across all our major markets. OUS markets were the biggest driver, including 10% year-over-year growth in Germany, 19% in France, and 29% in Japan. We also saw 4% active patient growth in the US, which had been flat in recent years. In 2026, we expect growth rates to stabilize in the low to mid-single digit range as these markets continue to mature.
Frank Leonard: Thank you, Bill, and good morning. I'm excited to speak to you in my new role as CEO and at a time when Novocure is evolving into a multi-indication platform company. 2025 was our most successful commercial year to date, and we expect to carry this positive momentum into 2026. Our GBM business remains core to our commercial operations. In 2025, we saw substantial active patient growth across all our major markets. OUS markets were the biggest driver, including 10% year-over-year growth in Germany, 19% in France, and 29% in Japan. We also saw 4% active patient growth in the US, which had been flat in recent years. In 2026, we expect growth rates to stabilize in the low to mid-single digit range as these markets continue to mature.
Speaker #5: 2025 was our most successful commercial year to date, and we expect to carry this positive momentum into 2026. Our business remains core; our GBM business remains core to our commercial operations.
Speaker #5: In 2025, we saw substantial active patient growth across all our major markets. OUS markets were the biggest driver, including 10% year-over-year growth in Germany, 19% in France, and 29% in Japan.
Speaker #5: We also saw 4% active patient growth in the US, which had been flat in recent years. In 2026, we expect growth rates to stabilize in the low to mid single-digit range as these markets continue to mature.
Speaker #5: We should also see a tailwind from new market launches in Spain, Czechia, and British Columbia. Though first-year revenue contributions are likely to be modest.
Frank Leonard: We should also see a tailwind from new market launches in Spain, Czechia, and British Columbia, though first-year revenue contributions are likely to be modest. Turning to Optune Lua, we are preparing to launch in Japan. Japan represents a promising opportunity for Optune Lua, given first and second-line use of immune checkpoint inhibitors is standard of care in Japan. We expect to receive our final reimbursement approval in the coming weeks. We will then be able to launch in Japan with national coverage and pricing. As we've previously stated, the Optune Lua launch has been slower than we originally projected in the US and Germany. We have right-sized our marketing spend based on the current demand and are prioritizing investments in indications with a higher return potential, such as pancreatic cancer. Finally, I will turn now to our newest FDA approval, Optune Pax for locally advanced pancreatic cancer.
Frank Leonard: We should also see a tailwind from new market launches in Spain, Czechia, and British Columbia, though first-year revenue contributions are likely to be modest. Turning to Optune Lua, we are preparing to launch in Japan. Japan represents a promising opportunity for Optune Lua, given first and second-line use of immune checkpoint inhibitors is standard of care in Japan. We expect to receive our final reimbursement approval in the coming weeks. We will then be able to launch in Japan with national coverage and pricing. As we've previously stated, the Optune Lua launch has been slower than we originally projected in the US and Germany. We have right-sized our marketing spend based on the current demand and are prioritizing investments in indications with a higher return potential, such as pancreatic cancer. Finally, I will turn now to our newest FDA approval, Optune Pax for locally advanced pancreatic cancer.
Speaker #5: Turning to Optune LUA, we are preparing to launch in Japan. Japan represents a promising opportunity for Optune LUA given first and second-line use of immune checkpoint inhibitors is standard of care in Japan.
Speaker #5: We expect to receive our final reimbursement approval in the coming weeks. We will then be able to launch in Japan with national coverage and pricing.
Speaker #5: As we've previously stated, the Optune LUA launch has been slower than we originally projected in the US and Germany. We have right-sized our marketing spend based on the current demand and are prioritizing investments in indications with a higher return potential, such as pancreatic cancer.
Speaker #5: Finally, I will turn now to our newest FDA approval, Optune PACs for locally advanced pancreatic cancer. We are very pleased to have received FDA approval and appreciate the agency's partnership throughout the review process.
Frank Leonard: We are very pleased to have received FDA approval and appreciate the agency's partnership throughout the review process. The industry standard time for PMA reviews is between nine to 12 months. In the case of Optune PAX, the FDA review was completed exactly at the 180 day mark, with approval received on 11 February. We have commenced our Optune PAX launch and are now certifying prescribers and receiving prescriptions. We have designed the launch plans for Optune PAX to make prescribing and starting patients as easy as possible for physicians, including emphasizing the use of our HCP portal to enable digital prescriptions. We are also giving the prescriber more discretion in patient selection rather than detailing to a preferred patient profile. We are also able to leverage our established torso sales force for the Optune PAX launch.
Frank Leonard: We are very pleased to have received FDA approval and appreciate the agency's partnership throughout the review process. The industry standard time for PMA reviews is between nine to 12 months. In the case of Optune PAX, the FDA review was completed exactly at the 180 day mark, with approval received on 11 February. We have commenced our Optune PAX launch and are now certifying prescribers and receiving prescriptions. We have designed the launch plans for Optune PAX to make prescribing and starting patients as easy as possible for physicians, including emphasizing the use of our HCP portal to enable digital prescriptions. We are also giving the prescriber more discretion in patient selection rather than detailing to a preferred patient profile. We are also able to leverage our established torso sales force for the Optune PAX launch.
Speaker #5: The industry standard time for PMA reviews is between 9 to 12 months. In the case of Optune PACs, the FDA review was completed exactly at the 180-day mark, with approval received on February 11th.
Speaker #5: We have commenced our Optune PACs launch and are now certifying prescribers and receiving prescriptions. We have designed the launch plans for Optune PACs to make prescribing and starting patients as easy as possible for physicians, including emphasizing the use of our HCP portal to enable digital prescriptions.
Speaker #5: We are also giving the prescriber more discretion in patient selection rather than detailing to a preferred patient profile. We are also able to leverage our established torso sales force for the Optune PACs launch.
Speaker #5: The existence of a trained team significantly lessens the educational burden of onboarding, a new team, and enables us to take advantage of the established team's deep knowledge of TT Fields therapy.
Frank Leonard: The existence of a trained team significantly lessens the educational burden for onboarding a new team, and enables us to take advantage of the established team's deep knowledge of TTFields therapy. This team has built extensive connections with physicians, which will prove invaluable given that some medical oncologists treat both lung and pancreatic cancer patients. There are a lot of similarities between GBM and pancreatic cancer that give us confidence in both the market opportunity and our ability to commercialize Optune Pax. Both cancers are typically diagnosed at a late stage and are incredibly difficult to treat. Both cancers have properties that limit the bioavailability of systemic therapies, making these tumors prime targets for a physical treatment approach. Both tumors have limited approved therapeutic options for patients. We are eager to begin treating patients in the coming weeks.
Frank Leonard: The existence of a trained team significantly lessens the educational burden for onboarding a new team, and enables us to take advantage of the established team's deep knowledge of TTFields therapy. This team has built extensive connections with physicians, which will prove invaluable given that some medical oncologists treat both lung and pancreatic cancer patients. There are a lot of similarities between GBM and pancreatic cancer that give us confidence in both the market opportunity and our ability to commercialize Optune Pax. Both cancers are typically diagnosed at a late stage and are incredibly difficult to treat. Both cancers have properties that limit the bioavailability of systemic therapies, making these tumors prime targets for a physical treatment approach. Both tumors have limited approved therapeutic options for patients. We are eager to begin treating patients in the coming weeks.
Speaker #5: This team has built extensive connections with physicians, which will prove invaluable given that some medical oncologists treat both lung and pancreatic cancer patients. There are a lot of similarities between GBM and pancreatic cancer that give us confidence in both the market opportunity and our ability to commercialize Optune PACs.
Speaker #5: Both cancers are typically diagnosed at a late stage and are incredibly difficult to treat. Both cancers have properties that limit the bioavailability of systemic therapies, making these tumors prime targets for a physical treatment approach.
Speaker #5: And both tumors have limited approved therapeutic options for patients. We are eager to begin treating patients in the coming weeks. Now is an exciting time to step into the CEO role at NovaCure.
Frank Leonard: Now is an exciting time to step into the CEO role at Novocure. Since I joined the company in 2010, we have had numerous clinical, regulatory, and commercial milestones across multiple indications, we are now primed to enter our next era of substantial growth. I'm thankful for the opportunity to lead at such an exciting time. I want to thank all of my colleagues for their dedication and support during the transition. I'll now pass the call over to Christoph to review our Q4 and full year 2025 financials, as well as our guidance for 2026.
Frank Leonard: Now is an exciting time to step into the CEO role at Novocure. Since I joined the company in 2010, we have had numerous clinical, regulatory, and commercial milestones across multiple indications, we are now primed to enter our next era of substantial growth. I'm thankful for the opportunity to lead at such an exciting time. I want to thank all of my colleagues for their dedication and support during the transition. I'll now pass the call over to Christoph to review our Q4 and full year 2025 financials, as well as our guidance for 2026.
Speaker #5: Since I joined the company in 2010, we have had numerous clinical, regulatory, and commercial milestones. Across multiple indications, and we are now primed to enter our next era of substantial growth.
Speaker #5: I'm thankful for the opportunity to lead at such an exciting time, and I want to thank all of my colleagues for their dedication and support during the transition.
Speaker #5: I'll now pass the call over to Christoph to review our Q4 and full-year 2025 financials, as well as our guidance for 2026.
Speaker #1: Thank you, Frank.
Christoph Brackmann: Thank you, Frank. We closed 2025 with continued momentum, delivering record net revenue for both the quarter and full year. Q4 net revenue was $174 million, and full year net revenue totaled $655 million, representing 8% year-over-year growth for both periods. Growth was primarily driven by continued expansion in ex-US markets, particularly Germany, France, and Japan, reflecting solid underlying demand and increased active patient counts. Foreign exchange provided a tailwind of approximately $5 million in Q4, and $11 million for the full year compared to 2024. We recognized $3.5 million from Optune Lua claims in the quarter, including $2.4 million from non-small cell lung cancer. For the full year, Optune Lua revenue was $10.4 million, including $5.8 million from non-small cell lung cancer patients.
Christoph Brackmann: Thank you, Frank. We closed 2025 with continued momentum, delivering record net revenue for both the quarter and full year. Q4 net revenue was $174 million, and full year net revenue totaled $655 million, representing 8% year-over-year growth for both periods. Growth was primarily driven by continued expansion in ex-US markets, particularly Germany, France, and Japan, reflecting solid underlying demand and increased active patient counts. Foreign exchange provided a tailwind of approximately $5 million in Q4, and $11 million for the full year compared to 2024. We recognized $3.5 million from Optune Lua claims in the quarter, including $2.4 million from non-small cell lung cancer. For the full year, Optune Lua revenue was $10.4 million, including $5.8 million from non-small cell lung cancer patients.
Speaker #6: Thank you, Frank.
Speaker #1: We closed 2025 with continued momentum, delivering record net revenue for both the quarter and full year. Fourth quarter net revenue was $174 million, and full-year net revenue totaled $655 million, representing 8% year-over-year growth for both periods.
Speaker #1: Growth was primarily driven by continued expansion in ex-US markets, particularly Germany, France, and Japan, reflecting solid underlying demand and increased active patient counts. Foreign exchange provided a tailwind of approximately $5 million in Q4 and $11 million for the full year compared to 2024.
Speaker #1: We recognized $3.5 million from Optune LUA claims in the quarter, including $2.4 million from non-small cell lung cancer. For the full year, Optune LUA revenue was $10.4 million, including $5.8 million from non-small cell lung cancer patients.
Speaker #1: I would also like to briefly address the recent Medicare billing situation. Earlier this month, CMS notified us that our billing privileges were halted due to an administrative issue identified during the DME supplier revalidation process.
Christoph Brackmann: I would also like to briefly address the recent Medicare billing situation. Earlier this month, CMS notified us that our billing privileges were halted due to an administrative issue identified during the DME supplier revalidation process. We engaged with the agency quickly, submitted a corrective action plan the following business day, and completed our required re-inspection. Two days ago, we were notified that CMS rescinded the revocation and directed that our Medicare enrollment and billing privileges be reinstated retroactively to 17 December 2025. As a result, we do not expect any negative impact on revenue recognition from this matter. We are pleased that the issue is resolved and are appreciative of the agency's partnership in addressing the issue swiftly.
Christoph Brackmann: I would also like to briefly address the recent Medicare billing situation. Earlier this month, CMS notified us that our billing privileges were halted due to an administrative issue identified during the DME supplier revalidation process. We engaged with the agency quickly, submitted a corrective action plan the following business day, and completed our required re-inspection. Two days ago, we were notified that CMS rescinded the revocation and directed that our Medicare enrollment and billing privileges be reinstated retroactively to 17 December 2025. As a result, we do not expect any negative impact on revenue recognition from this matter. We are pleased that the issue is resolved and are appreciative of the agency's partnership in addressing the issue swiftly.
Speaker #1: We engaged with the agency quickly submitted a corrective action plan the following business day and completed our required reinspection. Two days ago, we were notified that CMS rescinded the revocation and directed that our Medicare enrollment and billing privileges be reinstated retroactively to December 17th, 2025.
Speaker #1: As a result, we do not expect any negative impact on revenue recognition from this matter. We are pleased that the issue is resolved and are appreciative of the agency's partnership in addressing the issue swiftly.
Speaker #1: Looking ahead to 2026, this morning we issued annual net revenue guidance that constant exchange rates of $675 million to $705 million. Representing year-over-year growth between 3 and 8%.
Christoph Brackmann: Looking ahead to 2026, this morning, we issued annual net revenue guidance at constant exchange rates of $675 million to $705 million, representing year-over-year growth between 3% and 8%. This assumes Optune Gio net revenue growth in the low to mid-single digits, and net revenue contributions from non-GBM products of $15 million to $25 million, compared to $10 million in 2025. Moving down the P&L. Q4 gross margin was 76% and 75% for the full year, compared to 79% and 77% for Q4 and full year 2024. The decrease was primarily driven by a decrease in prior period collections in the US and increased costs associated with the HFE rates and tariffs. For 2026, we expect gross margin in the mid-70s percentage range.
Christoph Brackmann: Looking ahead to 2026, this morning, we issued annual net revenue guidance at constant exchange rates of $675 million to $705 million, representing year-over-year growth between 3% and 8%. This assumes Optune Gio net revenue growth in the low to mid-single digits, and net revenue contributions from non-GBM products of $15 million to $25 million, compared to $10 million in 2025. Moving down the P&L. Q4 gross margin was 76% and 75% for the full year, compared to 79% and 77% for Q4 and full year 2024. The decrease was primarily driven by a decrease in prior period collections in the US and increased costs associated with the HFE rates and tariffs. For 2026, we expect gross margin in the mid-70s percentage range.
Speaker #1: This assumes Optune GEO net revenue growth in the low to mid-single digits and net revenue contributions from non-GBM products of 15 to 25 million dollars, compared to $10 million in 2025.
Speaker #1: Moving down the P&L, fourth quarter gross margin was 76% and 75% for the full year compared to 79% and 77% for the fourth quarter and full year 2024.
Speaker #1: The decrease was primarily driven by a decrease in prior period collections in the US and increased costs associated with the age-of-year raise and tariffs.
Speaker #1: For 2026, we expect gross margin in the mid-70s percentage range. Research and development costs in the quarter were $61 million, an increase of 19% from the same period last year.
Christoph Brackmann: Research and development costs in the quarter were $61 million, an increase of 19% from the same period last year, and $225 million for the full year, an increase of 7%. The quarterly increase was driven by increased costs related to the KEYNOTE-D58 and LUNAR-2 phase 3 trials and regulatory costs. Sales and marketing expenses in the quarter were $69 million, an increase of 2% from Q4 2024, and full-year sales and marketing expenses were $240 million, flat year-over-year. The increase in the quarter was driven by increased marketing activities related to new indications. G&A expenses for Q4 were $43 million, a decrease of 41% and $178 million for the full year, a decrease of 6% from 2024.
Christoph Brackmann: Research and development costs in the quarter were $61 million, an increase of 19% from the same period last year, and $225 million for the full year, an increase of 7%. The quarterly increase was driven by increased costs related to the KEYNOTE-D58 and LUNAR-2 phase 3 trials and regulatory costs. Sales and marketing expenses in the quarter were $69 million, an increase of 2% from Q4 2024, and full-year sales and marketing expenses were $240 million, flat year-over-year. The increase in the quarter was driven by increased marketing activities related to new indications. G&A expenses for Q4 were $43 million, a decrease of 41% and $178 million for the full year, a decrease of 6% from 2024.
Speaker #1: And $225 million for the full year, an increase of 7%. The quarterly increase was driven by increased costs related to the KEYNOTE D58 and LUNAR 2 Phase 3 trials, and regulatory costs.
Speaker #1: Sales and marketing expenses in the quarter were $69 million, an increase of 2% from Q4 2024. And full-year sales and marketing expenses were $240 million, flat year-over-year.
Speaker #1: The increase in the quarter was driven by increased marketing activities related to new indications. GNA expenses for the fourth quarter were $43 million, a decrease of 41% and $178 million for the full year, a decrease of 6% from 2024.
Speaker #1: The primary driver for the quarter was lower share-based compensation expenses related to 2020 PSUs triggered by the approval of Optune LUA in 2024. As noted in the 10-K today, we will have a similar charge in Q1 triggered by the Optune PACs approval.
Christoph Brackmann: The primary driver for Q4 was lower share-based compensation expenses related to 2020 PSUs, triggered by the approval of Optune Lua in 2024. As noted in the 10-K today, we will have a similar charge in Q1, triggered by the Optune Pax approval. Net loss for Q4 was $24 million, with a loss per share of $0.22. Full year net loss was $136 million, or $1.22 per share. Adjusted EBITDA in Q4 was negative $16 million and negative $34 million for the full year. Our cash and investment balance at the end of Q4 was $448 million. In Q4, we repaid $561 million of convertible notes in cash.
Christoph Brackmann: The primary driver for Q4 was lower share-based compensation expenses related to 2020 PSUs, triggered by the approval of Optune Lua in 2024. As noted in the 10-K today, we will have a similar charge in Q1, triggered by the Optune Pax approval. Net loss for Q4 was $24 million, with a loss per share of $0.22. Full year net loss was $136 million, or $1.22 per share. Adjusted EBITDA in Q4 was negative $16 million and negative $34 million for the full year. Our cash and investment balance at the end of Q4 was $448 million. In Q4, we repaid $561 million of convertible notes in cash.
Speaker #1: Net loss for the quarter was $24 million, with a loss per share of 22 cents. Full-year net loss was $136 million, or $1.22 per share.
Speaker #1: Adjusted EBITDA in the quarter was negative 16 million dollars, a negative 34 million dollars for the full year. Our cash and investment balance at the end of Q4 was $448 million.
Speaker #1: In the fourth quarter, re-repayed $561 million of convertible notes in cash. We believe our current funds available, coupled with diligent expense management, will provide the necessary bridge as we bring new revenue streams online.
Christoph Brackmann: We believe our current funds available, coupled with diligent expense management, will provide the necessary bridge as we bring new revenue streams online. We have decided not to go beyond the $200 million already drawn from our current credit facility. As we look ahead to 2026, we are determined to make material progress towards our goal of driving profitable growth in the coming years. This morning, we issued adjusted EBITDA guidance of negative $20 million to break even for full year 2026. Overall, this reflects an acceleration of our plans to achieve adjusted EBITDA breakeven, driven by both our expectations of revenue growth as well as diligent expense management across the organization. With that, I'll turn the call back to the operator for Q&A.
Christoph Brackmann: We believe our current funds available, coupled with diligent expense management, will provide the necessary bridge as we bring new revenue streams online. We have decided not to go beyond the $200 million already drawn from our current credit facility. As we look ahead to 2026, we are determined to make material progress towards our goal of driving profitable growth in the coming years. This morning, we issued adjusted EBITDA guidance of negative $20 million to break even for full year 2026. Overall, this reflects an acceleration of our plans to achieve adjusted EBITDA breakeven, driven by both our expectations of revenue growth as well as diligent expense management across the organization. With that, I'll turn the call back to the operator for Q&A.
Speaker #1: Therefore, we have decided not to go beyond the $200 million already drawn from our current credit facility. As we look ahead to 2026, we are determined to make material progress towards our goal of driving profitable growth in the coming years.
Speaker #1: This morning, we issued adjusted EBITDA guidance of negative $20 million to break even for full year 2026. Overall, this reflects an acceleration of our plans to achieve adjusted EBITDA break even driven by both our expectations of revenue growth as well as diligent expense management across the organization.
Speaker #1: With that, I'll turn the call back to the operator for Q&A.
Operator: As a reminder, if you'd like to ask a question at this time, please press star one one on your touchtone phone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from Jason Bednar with Piper Sandler.
Operator: As a reminder, if you'd like to ask a question at this time, please press star one one on your touchtone phone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from Jason Bednar with Piper Sandler.
Speaker #2: As a reminder, if you'd like to ask a question at this time, please press star 11 on your touchstone phone. And wait for your name to be announced.
Speaker #2: To withdraw your question, please press star 11 again. Our first question comes from Jason Bedner with Piper Sandler.
Jason Bednar: Hey, good morning. Thanks for taking the questions, and congratulations on the recent approval of Optune Pax. You know, team, there's probably too many topics to choose from this morning. There's a lot going on here, but why don't I start first with the guidance? This is obviously a first for Novocure. Glad to see it. So can you talk about why it made sense now to give the guidance versus past years? Can you break out some of the contributions included within the revenue guide around maybe things like you're assuming with new international markets? I think you called out Spain, Czechia, and Canada. As well as whether you're assuming anything in the revenue and EBITDA guide from previously denied claims.
Jason Bednar: Hey, good morning. Thanks for taking the questions, and congratulations on the recent approval of Optune Pax. You know, team, there's probably too many topics to choose from this morning. There's a lot going on here, but why don't I start first with the guidance? This is obviously a first for Novocure. Glad to see it. So can you talk about why it made sense now to give the guidance versus past years? Can you break out some of the contributions included within the revenue guide around maybe things like you're assuming with new international markets? I think you called out Spain, Czechia, and Canada. As well as whether you're assuming anything in the revenue and EBITDA guide from previously denied claims.
Speaker #3: Hey, good morning. Thanks for taking the questions. And congratulations on the recent approval of Optune PACs. Team, there's probably too many topics to choose from this morning.
Speaker #3: There's a lot going on here. But why don't I start first with the guidance, this obviously a first for NovaCure. Glad to see it.
Speaker #3: So, can you talk about why it made sense now to give the guidance versus past years? And then can you break out some of the contributions included within the revenue guide around maybe things like what you're assuming with new international markets? I think you called out Spain, Czechia, and Canada.
Speaker #3: And then as well as whether you're assuming anything in the revenue and EBITDA guide from previously denied claims.
Frank Leonard: Thanks, Jason. This is Frank. I'll start with the top line, and then I'll hand it to Christoph to go into some of the assumptions. You know, first, I just want to also say thanks for the recognition of the many positive headlines we had in the last quarter in closing out 2025. It certainly has been an exciting time here at Novocure. You know, Jason, as I came into the role as CEO, one of the things we did is really try to spend as much time with our investor community as possible. One of the core messages that we've heard is that, you know, we need to speak more clearly in terms of setting expectations of what we can accomplish in the coming year.
Frank Leonard: Thanks, Jason. This is Frank. I'll start with the top line, and then I'll hand it to Christoph to go into some of the assumptions. You know, first, I just want to also say thanks for the recognition of the many positive headlines we had in the last quarter in closing out 2025. It certainly has been an exciting time here at Novocure. You know, Jason, as I came into the role as CEO, one of the things we did is really try to spend as much time with our investor community as possible. One of the core messages that we've heard is that, you know, we need to speak more clearly in terms of setting expectations of what we can accomplish in the coming year.
Speaker #4: Thanks, Jason. This is Frank. I'll start with top line. And then I'll hand it to Christoph to go into some of the assumptions. First, I just want to also say thanks for the recognition of the many positive headlines we had in the last quarter and closing out 2025.
Speaker #4: It certainly has been an exciting time here at NovaCure. Jason, as I came into the role as CEO, one of the things we did is really try to spend as much time with our investor community as possible.
Speaker #4: One of the core messages that we've heard is that we need to speak more clearly in terms of setting expectations of what we can accomplish in a coming year.
Frank Leonard: We're taking that first step today with guidance where, you know, we really want to send the signal first at the top line that, you know, we are committed to returning the company to steady growth. You know, this is the first year where the Optune Pax will build a foundation that we can make even stronger going out to 2027. You know, two is that we're sending a very clear signal that we want to drive to adjusted EBITDA break even as a possibility this year, because we've heard the message loudly and clearly that we need to have both growth and profitability. You know, lastly, I think I just would emphasize that as a company, we're trying to send the signal that we're moving up the maturity curve.
Speaker #4: And we're taking that first step today with guidance where we really want to send the signal first at the top line that we are committed to returning the company to steady growth.
Frank Leonard: We're taking that first step today with guidance where, you know, we really want to send the signal first at the top line that, you know, we are committed to returning the company to steady growth. You know, this is the first year where the Optune Pax will build a foundation that we can make even stronger going out to 2027. You know, two is that we're sending a very clear signal that we want to drive to adjusted EBITDA break even as a possibility this year, because we've heard the message loudly and clearly that we need to have both growth and profitability. You know, lastly, I think I just would emphasize that as a company, we're trying to send the signal that we're moving up the maturity curve.
Speaker #4: And this is a first year where the Optune PACs will build a foundation that we can make even stronger going out to 2027. Two is that we're sending a very clear signal that we want to drive to adjusted EBITDA break even.
Speaker #4: As a possibility this year, because we've heard the message loudly and clearly that we need to have both growth and profitability. And lastly, I think I would just emphasize that, as a company, we're trying to send the signal that we're moving up the maturity curve.
Frank Leonard: We've been a public company for 10 years. We think this is a necessary and important step to take right now. Christoph?
Speaker #4: We've been a public company for 10 years. We think this is a necessary and important step to take right now. So, Christoph.
Frank Leonard: We've been a public company for 10 years. We think this is a necessary and important step to take right now. Christoph?
Speaker #5: Yeah, thank you. So yeah, on the specifics on guidance or the underlying assumptions, on the revenue side, there's really three areas that we are thinking of in terms of growth.
Christoph Brackmann: Yeah. Thank you. On the specifics, on guidance or the underlying assumptions, on the revenue side, there's really three areas that we are thinking of in terms of growth. There's our GBM business in established markets, where we expect growth in the low to mid single digit growth, mid single digit range. We have GBM in newer markets. An example of this would be Spain or Czechia, or also the recent approval in Canada that we announced. These will be modest contributions in 2026 as we ramp in 2026 in those markets. The third bucket of growth would be new indications. Yeah, that's also where, as you can see, we say we are expecting contributions in the range of $15 to $25 million.
Christoph Brackmann: Yeah. Thank you. On the specifics, on guidance or the underlying assumptions, on the revenue side, there's really three areas that we are thinking of in terms of growth. There's our GBM business in established markets, where we expect growth in the low to mid single digit growth, mid single digit range. We have GBM in newer markets. An example of this would be Spain or Czechia, or also the recent approval in Canada that we announced. These will be modest contributions in 2026 as we ramp in 2026 in those markets. The third bucket of growth would be new indications. Yeah, that's also where, as you can see, we say we are expecting contributions in the range of $15 to $25 million.
Speaker #5: There's our GBM business and established markets. Where we expect growth in the low to mid-single digit growth, mid-single digit range. Then we have GBM in newer markets, so an example of this would be Spain or Czechia or also the recent approval in Canada that we announced.
Speaker #5: Now, these will be modest contributions in 2026 as we ramp in 2026 in those markets. And then the third bucket of growth would be new indications.
Speaker #5: And yeah, that's also where as you can see, we say we are expecting contributions in the range of 15 to 25 million. So growth over prior year connected to the launches that we have with Optune LUA in Japan and Optune PACs in the US.
Christoph Brackmann: Growth over prior year, connected to the launches that we have with Optune Lua in Japan and Optune Pax in the US, as well in other markets.
Christoph Brackmann: Growth over prior year, connected to the launches that we have with Optune Lua in Japan and Optune Pax in the US, as well in other markets.
Speaker #5: As well in other markets.
Jason Bednar: All right. Very helpful.
Jason Bednar: All right. Very helpful.
Speaker #3: All right. Very helpful.
Speaker #2: Our next question comes from Vijay Kumar with Evercore ISI.
Operator: Our next question comes from Vijay Kumar with Evercore ISI.
Operator: Our next question comes from Vijay Kumar with Evercore ISI.
Speaker #6: Hi. This is Kevin on for Vijay. Thanks for taking our question. Just the one on Optune Geo. It looks like the guidance assumes a low to mid-single digit revenue growth.
[Analyst] (Evercore ISI): Hi, this is Kevin on for Vijay. Thanks for taking our question. Just the one on Optune Gio. It looks like the guidance assumes a low to mid-single-digit revenue growth. My understanding is that this market, over the long term, is more of a mid-single-digit growth type of market. Is this just conservatism embedded in the guidance, or are you seeing a change in the market growth rate? Thank you.
[Company Representative] (Evercore ISI): Hi, this is Kevin on for Vijay. Thanks for taking our question. Just the one on Optune Gio. It looks like the guidance assumes a low to mid-single-digit revenue growth. My understanding is that this market, over the long term, is more of a mid-single-digit growth type of market. Is this just conservatism embedded in the guidance, or are you seeing a change in the market growth rate? Thank you.
Speaker #6: My understanding is that this market over the long term is more of a mid-single digit growth. Type of market. Is this just conservative embedded in the guidance, or are you seeing a change in the market growth rate?
Speaker #6: Thank you.
Frank Leonard: Thank you for the question, Kevin. No, no, we are not seeing we're not signaling a conservatism or moderation. We're trying to signal that we believe, number one, we believe there are still many patients who will benefit from Optune Gio with glioblastoma. You know, as a reminder, we think in our mature markets, where on average, about 40% of the patients are getting a prescription for Optune Gio, and we think based on the data that we've already generated, that number should be significantly higher. The range is really intended to reiterate our ability that we've shown last year to grow in that, you know, mid-single digits range.
Speaker #4: Thank you for the question, Kevin. No, we are not seeing a we're not signaling a conservatism or a moderation. We're trying to signal that we believe that number one, we believe there are still many patients who will benefit from Optune Geo with glioblastoma.
Frank Leonard: Thank you for the question, Kevin. No, no, we are not seeing we're not signaling a conservatism or moderation. We're trying to signal that we believe, number one, we believe there are still many patients who will benefit from Optune Gio with glioblastoma. You know, as a reminder, we think in our mature markets, where on average, about 40% of the patients are getting a prescription for Optune Gio, and we think based on the data that we've already generated, that number should be significantly higher. The range is really intended to reiterate our ability that we've shown last year to grow in that, you know, mid-single digits range.
Speaker #4: As a reminder, we think in our mature markets, we're on average about 40% of the patients are getting a prescription for Optune Geo. And we think based on the data that we've already generated, that number should be significantly higher.
Speaker #4: And so the range is really intended to reiterate our ability that we've shown last year to grow in that mid-single digits range. But at the same time, to provide that guidance of a band that reflects all of the assumptions that could come into revenue, including just including the various puts and takes on when revenue comes online.
Frank Leonard: At the same time, you know, to provide that guidance of a band that reflects all of the assumptions that could come into revenue, including, you know, the various puts and takes on when revenue comes online.
Frank Leonard: At the same time, you know, to provide that guidance of a band that reflects all of the assumptions that could come into revenue, including, you know, the various puts and takes on when revenue comes online.
Speaker #2: Our next question comes from Larry Beagleson with Wells Fargo.
Operator: Our next question comes from Larry Biegelsen with Wells Fargo.
Operator: Our next question comes from Larry Biegelsen with Wells Fargo.
[Analyst] (Wells Fargo): Hi, it's Lee calling in for Larry. Thanks for taking the question. I have to, I think, first on adding our congrats on the PAX approval as well, coming in earlier than expected. Just on that product, can you just talk about, you know, based on the approved label, how do you think the device will be prescribed? Specifically, you know, what are the lessons learned from the lung launch that you can apply here to ensure success? I have a follow-up regarding the guidance.
[Company Representative] (Wells Fargo): Hi, it's Lee calling in for Larry. Thanks for taking the question. I have to, I think, first on adding our congrats on the PAX approval as well, coming in earlier than expected. Just on that product, can you just talk about, you know, based on the approved label, how do you think the device will be prescribed? Specifically, you know, what are the lessons learned from the lung launch that you can apply here to ensure success? I have a follow-up regarding the guidance.
Speaker #7: I have two concrete. First, I'm adding a congrats on the PACs approval as well coming in earlier than expected. Just on that product, can you just talk about based on the approved label, how do you think the device will be prescribed and used and specifically what are the lessons learned from the lung launch that you can apply here to ensure success?
Speaker #7: And I have a follow-up regarding the guidance.
Speaker #4: Yes. Thankfully, this is Frank. I'll start. And I might turn it to Christoph at the end to just comment on the market size itself.
Frank Leonard: Yes, thanks, Lee. This is Frank. I'll start, and I might turn it to Christoph at the end to just comment on the market size itself. First, we're very pleased with the approval for Optune Pax, both the label that we received as well as the timing, and I think that, you know, the quality of the data that we brought to the FDA should really be underlined in that sense, that we were able to secure this 180-day review cycle. Optune Pax is being approved for locally advanced pancreatic cancer in a first-line setting in concurrent use with nab-paclitaxel plus gemcitabine. I want to emphasize, that's a first-line patient with locally advanced disease, so still focal disease. We think this is a highly motivated patient population.
Frank Leonard: Yes, thanks, Lee. This is Frank. I'll start, and I might turn it to Christoph at the end to just comment on the market size itself. First, we're very pleased with the approval for Optune Pax, both the label that we received as well as the timing, and I think that, you know, the quality of the data that we brought to the FDA should really be underlined in that sense, that we were able to secure this 180-day review cycle. Optune Pax is being approved for locally advanced pancreatic cancer in a first-line setting in concurrent use with nab-paclitaxel plus gemcitabine. I want to emphasize, that's a first-line patient with locally advanced disease, so still focal disease. We think this is a highly motivated patient population.
Speaker #4: So first, we're very pleased with the approval for Optune PACs. Both the label that we received as well as the timing and I think that the quality of the data that we brought to the FDA should really be underlined in that sense that we were able to secure this 180-day review cycle.
Speaker #4: Optune PACs is being approved for locally advanced pancreatic cancer in a first-line setting in concurrent use with NAB paclitaxel plus gemcitabine. So I want to emphasize that's a first-line patient with locally advanced disease, so still focal disease.
Speaker #4: We think this is a highly motivated patient population. It's a population also that has had really very limited treatment options to date. And we think this fits very nicely with our overall value proposition to physicians and to patients that we can bring this unique physical approach to layer on top of the existing systemic therapies that quite frankly have not been successful enough in pancreatic cancer.
Frank Leonard: It's a, it's a population also that has had really very limited treatment options to date. We think this fits very nicely with our overall value proposition to physicians and to patients, that we can bring this unique physical approach to layer on top of the existing systemic therapies that, quite frankly, have not been successful enough in pancreatic cancer. To answer the question, you know, directly, we believe within that label, that really is the core population that we can pursue first, and we're very happy that that is, because we believe it's a highly motivated patient and a highly motivated physician. Christoph, could you comment a bit on the market assumptions?
Frank Leonard: It's a, it's a population also that has had really very limited treatment options to date. We think this fits very nicely with our overall value proposition to physicians and to patients, that we can bring this unique physical approach to layer on top of the existing systemic therapies that, quite frankly, have not been successful enough in pancreatic cancer. To answer the question, you know, directly, we believe within that label, that really is the core population that we can pursue first, and we're very happy that that is, because we believe it's a highly motivated patient and a highly motivated physician. Christoph, could you comment a bit on the market assumptions?
Speaker #4: So, to answer the question directly, we believe within that label, that really is the core population that we can pursue first. And we're very happy that that is, because we believe it's a highly motivated patient and a highly motivated physician.
Speaker #4: And Christoph, could you comment a bit on the market assumptions?
Speaker #5: Yeah, sure. So we estimate the TAM for locally advanced pancreatic cancer in the US to be 15,000 patients. On an annual basis, this is down from about 60,000 patients being diagnosed with PDAC on an annual basis.
Christoph Brackmann: Yeah, sure. We estimate the TAM for locally advanced pancreatic cancer in the US to be 15,000 patients on an annual basis. This is down from about 60,000 patients being diagnosed with PDAC on an annual basis, and then about a third is in the locally advanced pancreatic setting.
Christoph Brackmann: Yeah, sure. We estimate the TAM for locally advanced pancreatic cancer in the US to be 15,000 patients on an annual basis. This is down from about 60,000 patients being diagnosed with PDAC on an annual basis, and then about a third is in the locally advanced pancreatic setting.
Speaker #5: And then about a third is in the locally advanced pancreatic setting.
Speaker #2: Our next question comes from Jonathan Chang with Hearing Partners.
Operator: Our next question comes from Jonathan Chang with Leerink Partners.
Operator: Our next question comes from Jonathan Chang with Leerink Partners.
Speaker #8: Good morning. This is Albert Augustinus on for Jonathan Chang. Thanks for taking my question and congrats on the approval of Optune PACs. Regarding that topic, how much Salesforce are you allocating for Optune PACs?
[Analyst] (Leerink Partners): Good morning. This is Albert Agustinus on for Jonathan Chang. Thanks for taking my question, congrats on the approval of Optune Pax. Regarding that topic, how much sales force are you allocating for Optune Pax? Do you foresee or have you recruited new commercial team members to accommodate for this launch, or is it more of a reallocation of the current commercial team? Thanks.
Albert Agustinus: Good morning. This is Albert Agustinus on for Jonathan Chang. Thanks for taking my question, congrats on the approval of Optune Pax. Regarding that topic, how much sales force are you allocating for Optune Pax? Do you foresee or have you recruited new commercial team members to accommodate for this launch, or is it more of a reallocation of the current commercial team? Thanks.
Speaker #8: Do you foresee or have you recruited new commercial team members to accommodate for this launch, or is it more of a reallocation of the current commercial team?
Speaker #8: Thanks.
Speaker #4: Thanks, Albert, for the question. We are very pleased that we have an established team that we've trained over the last two years to detail our Optune LUA product.
Frank Leonard: Thanks, Albert, for the question. We are very pleased that, you know, we have an established team that we've trained over the last 2 years to detail our Optune Lua product. That team that's already in the field and fully established is being repurposed is probably the wrong word, but I should say, tasked now with leading our pancreatic launch. We are not, we're not adding incremental sales headcount at this time. We are simply leveraging the team that we have.
Frank Leonard: Thanks, Albert, for the question. We are very pleased that, you know, we have an established team that we've trained over the last 2 years to detail our Optune Lua product. That team that's already in the field and fully established is being repurposed is probably the wrong word, but I should say, tasked now with leading our pancreatic launch. We are not, we're not adding incremental sales headcount at this time. We are simply leveraging the team that we have.
Speaker #4: That team that's already in the field and fully established is—'being repurposed' is probably the wrong word, but I should say—tasked now with leading our pancreatic launch.
Speaker #4: So we are not adding incremental sales headcount at this time. We are simply leveraging the team that we have.
Speaker #8: Thank you.
[Analyst] (Leerink Partners): Thank you.
Albert Agustinus: Thank you.
Operator: Our next question comes from Emily Bodner with H.C. Wainwright.
Operator: Our next question comes from Emily Bodner with H.C. Wainwright.
Speaker #2: Our next question comes from Emily Bodner with HC Wainwright.
[Analyst] (Evercore ISI): Hi, good morning. Thanks for taking the questions, and congrats on the Optune Pax approval. You, you guided to the $15 to $25 million in revenue for Optune Lua and Optune Pax this year. I'm curious if you could kind of give some more detail into how we should be thinking about revenue contributions, specifically for Optune Pax this year, as you're kind of getting reimbursement plans in place. Then maybe a follow-up to the prior question: How much of your sales and marketing force that you already have is kind of in place for HCPs that are going to be covering locally advanced pancreatic patients based on your GBM and non-small cell lung cancer launches? Thanks.
Emily Bodner: Hi, good morning. Thanks for taking the questions, and congrats on the Optune Pax approval. You, you guided to the $15 to $25 million in revenue for Optune Lua and Optune Pax this year. I'm curious if you could kind of give some more detail into how we should be thinking about revenue contributions, specifically for Optune Pax this year, as you're kind of getting reimbursement plans in place. Then maybe a follow-up to the prior question: How much of your sales and marketing force that you already have is kind of in place for HCPs that are going to be covering locally advanced pancreatic patients based on your GBM and non-small cell lung cancer launches? Thanks.
Speaker #9: Hi, good morning. Thanks for taking the questions and congrats on the Optune PACs approval. So you guided to the 15 to 25 million in revenue for Optune LUA and Optune PACs this year.
Speaker #9: I'm curious if you could kind of give some more detail into how we should be thinking about revenue contributions specifically for Optune PACs this year as you're kind of getting reimbursement plans in place.
Speaker #9: And then maybe a follow-up to the prior question. How much of your sales and marketing force that you already have is kind of in place for HCPs that are going to be covering locally advanced pancreatic patients based on your GBM and non-small cell lung cancer launches?
Speaker #9: Thanks.
Speaker #4: Excellent. Thanks, Emily. I'll start and I'll turn it over to Christoph. Just as a reminder for everyone, as we launch in a new indication, we do, as a medical device, need to go through a process of working with the payers to establish coverage policies and in some cases, having updates to our contracts with the payers in the United States to then move towards a position where we have a more direct correlation between active patients and revenue.
Frank Leonard: Excellent. Thanks, Emily. I'll start, and I'll turn it over to Christoph. Just as a reminder for everyone, as we launch in a new indication, we do, as a medical device, need to go through a process of working with the payers to establish coverage policies, and in some cases, having updates to our contracts with the payers in the United States, to then move towards a, you know, position where we have a more direct correlation between active patients and revenue. At the start, you know, we will start all of the patients, and we'll begin working through an appeals process, just as we've done with glioblastoma and lung before. It's a process that we're quite familiar with, and we're confident we're going to be able to work through it.
Frank Leonard: Excellent. Thanks, Emily. I'll start, and I'll turn it over to Christoph. Just as a reminder for everyone, as we launch in a new indication, we do, as a medical device, need to go through a process of working with the payers to establish coverage policies, and in some cases, having updates to our contracts with the payers in the United States, to then move towards a, you know, position where we have a more direct correlation between active patients and revenue. At the start, you know, we will start all of the patients, and we'll begin working through an appeals process, just as we've done with glioblastoma and lung before. It's a process that we're quite familiar with, and we're confident we're going to be able to work through it.
Speaker #4: At the start, we will start all of the patients and we'll begin working through an appeals process. Just as we've done with glioblastoma and lung before, and it's a process that we're quite familiar with and we're confident we're going to be able to work through it, but that will mean that in this launch period, you will see revenue not correlate directly with active patients because there will be a lag as we establish the coverage policies and the payment policies with payers in the United States.
Frank Leonard: That will mean that in this launch period, you will see revenue not correlate directly with active patients because there will be a lag as we establish the coverage policies and the payment policies with payers in the United States. I'll flag that, you know, as always, for us, one of the most critical steps in that process is to secure an inclusion in the NCCN guidelines for the treatment of locally advanced pancreatic cancer. We have submitted that application, and we're hopeful to be included soon, and we think that will be one of the material steps this year towards securing the coverage policies that will drive some revenue this year, but ultimately, it'll be revenue that will come next year. Christoph?
Frank Leonard: That will mean that in this launch period, you will see revenue not correlate directly with active patients because there will be a lag as we establish the coverage policies and the payment policies with payers in the United States. I'll flag that, you know, as always, for us, one of the most critical steps in that process is to secure an inclusion in the NCCN guidelines for the treatment of locally advanced pancreatic cancer. We have submitted that application, and we're hopeful to be included soon, and we think that will be one of the material steps this year towards securing the coverage policies that will drive some revenue this year, but ultimately, it'll be revenue that will come next year. Christoph?
Speaker #4: I'll flag that as always for us, one of the most critical steps in that process is to secure a inclusion in the NCCN guidelines for the treatment of locally advanced pancreatic cancer.
Speaker #4: We have submitted that application. And we're hopeful to be included soon and we think that will be one of the material steps this year towards securing the coverage policies that will drive some revenue this year, but ultimately, it'll be revenue that will come next year.
Speaker #4: Christoph?
Speaker #5: Yeah, I think the only thing to add to what you said, Frank, maybe would be that similar to what we said for Optune LUA, we expected will take us about one to two years to get coverage on a more routine basis for commercial payers.
Christoph Brackmann: Yeah, I think, I mean, the only thing to add to what you said, Frank, maybe would be that, similar to what we said for Optune Lua, we expect it will take us about one to two years to get coverage on a more routine basis for commercial payers. That's also connected to the launch success, right? The more patients that we have on therapy, the easier we'll get to get coverage policies.
Christoph Brackmann: Yeah, I think, I mean, the only thing to add to what you said, Frank, maybe would be that, similar to what we said for Optune Lua, we expect it will take us about one to two years to get coverage on a more routine basis for commercial payers. That's also connected to the launch success, right? The more patients that we have on therapy, the easier we'll get to get coverage policies.
Speaker #5: And that's also connected to the launch success, right? The more patients that we have on therapy, the easier it will get to get coverage policies.
Speaker #4: And Christoph, there was also the question about sales and marketing expense.
Frank Leonard: Christoph, there was also the question about sales and marketing expense.
Frank Leonard: Christoph, there was also the question about sales and marketing expense.
Speaker #5: Yeah. So in terms of sales and marketing expense, as we I mean, as Frank alluded to earlier, we are basically reusing the field force.
Christoph Brackmann: Yeah. In terms of sales and marketing expense, as we, I mean, as Frank alluded to earlier, we are basically reusing this field force. When we built the field force for NSCLC last year and earlier, basically we thought of it as a torso-focused field force. From a field force perspective, there is no incremental, very small incremental spend, if any. Incremental spend on the pancreatic launch will be on the marketing side. Part of that already we had in Q4 of last year.
Christoph Brackmann: Yeah. In terms of sales and marketing expense, as we, I mean, as Frank alluded to earlier, we are basically reusing this field force. When we built the field force for NSCLC last year and earlier, basically we thought of it as a torso-focused field force. From a field force perspective, there is no incremental, very small incremental spend, if any. Incremental spend on the pancreatic launch will be on the marketing side. Part of that already we had in Q4 of last year.
Speaker #5: So when we built the field force for NACLC last year and earlier, basically, we thought of it as a torso-focused field force. And so from a field force perspective, there is no incremental or very small incremental spend, if any, incremental spend on the pancreatic launch will be on the marketing side, part of that already we had in Q4 of last year.
Operator: That concludes today's question and answer session. I'd like to turn the call back to Bill Doyle for closing remarks.
Operator: That concludes today's question and answer session. I'd like to turn the call back to Bill Doyle for closing remarks.
Speaker #2: That concludes today's question and answer session. I'd like to turn the call back to Bill Doyle for closing remarks.
Speaker #4: So in closing, I'd like to underline that 2025 was a year of strong execution at Novacure with record net revenue and record active patients.
William F. Doyle: In closing, I'd like to underline that 2025 was a year of strong execution at Novocure, with record net revenue and record active patients. We're very pleased with our two phase III presentations and publications, and the two PMAs submitted, which we think really create the foundation for success in the future. We're set to maintain that momentum with a catalyst-rich 2026. We're pleased to have already received the PMA approval for PANOVA-3 for Optune Pax, and to have submitted the regulatory filings in the EU and Japan. We're looking forward to the top-line results from PANOVA-3 four and TRIDENT.
Bill Doyle: In closing, I'd like to underline that 2025 was a year of strong execution at Novocure, with record net revenue and record active patients. We're very pleased with our two phase III presentations and publications, and the two PMAs submitted, which we think really create the foundation for success in the future. We're set to maintain that momentum with a catalyst-rich 2026. We're pleased to have already received the PMA approval for PANOVA-3 for Optune Pax, and to have submitted the regulatory filings in the EU and Japan. We're looking forward to the top-line results from PANOVA-3 four and TRIDENT.
Speaker #4: We're very pleased with our two phase three presentations and publications and the 2:00 PMA submitted, which we think really create the foundation for success in the future.
Speaker #4: We're set to maintain that momentum with a catalyst-rich 2026. We're pleased to have already received the PMA approval for Panova for Optune PACs and to have submitted the regulatory filings in the EU and Japan and we're looking forward to the top-line results from Panova 4 and Trident.
Speaker #4: On the commercial side, we expect to maintain our momentum as has been discussed on this call, and we're really excited to bring our products to patients in new markets, particularly Spain, Czechia, and in British Columbia.
William F. Doyle: On the commercial side, we expect to maintain our momentum, as has been discussed on this call, and we're really excited to bring our products to patients in new markets, particularly Spain, Czechia, and in British Columbia. We've really tried to emphasize to everyone today that we're focused on driving to profitability. As Frank said, 10 years in the public markets, we're ready to guide, and we're ready to make that one of our primary goals. We see a path to profitability and in fact, the potential to reach adjusted EBITDA breakeven this year. With that, I'd like to end by thanking you all for your continued interest and focus on Novocure, and in particular, I need to thank my colleagues.
Bill Doyle: On the commercial side, we expect to maintain our momentum, as has been discussed on this call, and we're really excited to bring our products to patients in new markets, particularly Spain, Czechia, and in British Columbia. We've really tried to emphasize to everyone today that we're focused on driving to profitability. As Frank said, 10 years in the public markets, we're ready to guide, and we're ready to make that one of our primary goals. We see a path to profitability and in fact, the potential to reach adjusted EBITDA breakeven this year. With that, I'd like to end by thanking you all for your continued interest and focus on Novocure, and in particular, I need to thank my colleagues.
Speaker #4: We've really tried to emphasize to everyone today that we're focused on driving to profitability. As Frank said, 10 years in the public markets, we're ready to guide and we're ready to make that one of our primary goals.
Speaker #4: We see a path to profitability, and in fact, the potential to reach adjusted EBITDA breakeven this year. With that, I'd like to end by thanking you all for your continued interest and focus on Novacure and in particular, I need to thank my colleagues, 2025 was a year of accomplishment and change.
William F. Doyle: 2025 was a year of accomplishment and change as we position the company for the exciting future that we see ahead of us.
Bill Doyle: 2025 was a year of accomplishment and change as we position the company for the exciting future that we see ahead of us.
Speaker #4: As we position the company for the exciting future that we see ahead of us.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.