Q1 2026 Novocure Ltd Earnings Call
Operator 2: Good day, and thank you for standing by. Welcome to the Novocure's Q1 2026 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Adam Daney. Please go ahead.
Operator: Good day, and thank you for standing by. Welcome to the Novocure's Q1 2026 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Adam Daney. Please go ahead.
Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone.
Speaker #1: You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded.
Speaker #1: I would now like to hand the conference over to your first speaker today, Adam Danney. Please go ahead.
Adam Daney: Good morning, and thank you for joining us to review Novocure's Q1 of 2026 financial performance. I'm joined on the phone today with our Executive Chairman, William Doyle, CEO Frank Leonard, Chief Innovation and Medical Officer Uri Weinberg, 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, novocure.com, on the Investor Relations page under Quarterly Reports. Before we start, I would like to remind you that our discussions during this conference call will include forward-looking statements. The 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.
Adam Daney: Good morning, and thank you for joining us to review Novocure's Q1 of 2026 financial performance. I'm joined on the phone today with our Executive Chairman, William Doyle, CEO Frank Leonard, Chief Innovation and Medical Officer Uri Weinberg, 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, novocure.com, on the Investor Relations page under Quarterly Reports. Before we start, I would like to remind you that our discussions during this conference call will include forward-looking statements. The 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 #2: Good morning, and thank you for joining us to review Novocure's first quarter 2026 financial performance. I'm joined on the phone today by our Executive Chairman, Bill Doyle; CEO, Frank Leonard; Chief Innovation and Medical Officer, Ori Weinberg; and CFO, Christoph Brackmann.
Speaker #2: 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, novacure.com.
Speaker #2: On the investor relations page, under quarterly reports. Before we start, I would like to remind you that our discussions during this conference call will include forward-looking statements, and the actual results could differ materially from those projected in these statements.
Speaker #2: 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 #2: 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.
Adam Daney: 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 net income without reasonable efforts. Reconciliations of non-GAAP to GAAP financial measures are included in the press release, earnings slides, and our Form 10-Q filed with the SEC today. These materials can all be accessed from the Investor Relations page on our website.
Adam Daney: 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 net income without reasonable efforts. Reconciliations of non-GAAP to GAAP financial measures are included in the press release, earnings slides, and our Form 10-Q filed with the SEC today. These materials can all be accessed from the Investor Relations page on our website.
Speaker #2: 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 #2: 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 #2: Reconciliations of non-GAAP to GAAP financial measures are included in the press release, earnings slides, and our informed 10-Q filed with the SEC today. These materials can our website.
Adam Daney: Following our prepared remarks, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.
Adam Daney: Following our prepared remarks, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.
Speaker #2: Following our prepared remarks, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.
Speaker #3: Thank you, Adam. This morning, we reported results for the first quarter of 2026, and I am pleased to say we've had a strong start to the year.
William Doyle: Thank you, Adam. This morning, we reported results for Q1 2026. I am pleased to say we've had a strong start to the year. Both active patients and net revenues grew at double digits rates year over year. Our launch in pancreatic cancer is off to a promising start. We are making progress on our journey to profitability. With a number of additional catalysts expected this year, we look forward to building on this strong Q1. On today's call, we will begin with a review of our pancreatic cancer program. Frank will then provide an update on our GBM and lung cancer programs. Christoph will conclude with a review of our Q1 financial performance before we open the line for questions.
Bill Doyle: Thank you, Adam. This morning, we reported results for Q1 2026. I am pleased to say we've had a strong start to the year. Both active patients and net revenues grew at double digits rates year over year. Our launch in pancreatic cancer is off to a promising start. We are making progress on our journey to profitability. With a number of additional catalysts expected this year, we look forward to building on this strong Q1. On today's call, we will begin with a review of our pancreatic cancer program. Frank will then provide an update on our GBM and lung cancer programs. Christoph will conclude with a review of our Q1 financial performance before we open the line for questions.
Speaker #3: Both active patients and net revenues grew at double digits rates year over year. Our launch in pancreatic cancer is off to a promising start, and we are making progress on our journey to profitability.
Speaker #3: With a number of additional catalysts expected this year, we look forward to building on this strong first quarter. On today's call, we will begin with a review of our pancreatic cancer program.
Speaker #3: Frank will then provide an update on our GBM and lung cancer programs. Christoph will conclude with a review of our first quarter financial performance before we open the line for questions.
Speaker #3: The leading news in the quarter was the FDA approval and subsequent US launch of Optune PACs for patients with locally advanced pancreatic cancer. Physician feedback has been positive since the Panova 3 data were presented, and published at ASCO last year.
William Doyle: The leading news in the quarter was the FDA approval and subsequent US launch of Optune Pax for patients with locally advanced pancreatic cancer. Physician feedback has been positive since the PANOVA-3 data were presented and published at ASCO last year. There is broad recognition of the importance of the outcomes observed, including extensions in overall survival and time to pain progression. We believe Optune Pax can play a significant role in the treatment of pancreatic cancer, and we are pleased to be bringing Optune Pax to pancreatic cancer patients. The early days of our Optune Pax commercial launch have been encouraging. We received FDA approval on 11 February.
Bill Doyle: The leading news in the quarter was the FDA approval and subsequent US launch of Optune Pax for patients with locally advanced pancreatic cancer. Physician feedback has been positive since the PANOVA-3 data were presented and published at ASCO last year. There is broad recognition of the importance of the outcomes observed, including extensions in overall survival and time to pain progression. We believe Optune Pax can play a significant role in the treatment of pancreatic cancer, and we are pleased to be bringing Optune Pax to pancreatic cancer patients. The early days of our Optune Pax commercial launch have been encouraging. We received FDA approval on 11 February.
Speaker #3: There is broad recognition of the importance of the outcomes observed including extensions and overall survival and time to pain progression. We believe Optune PACs can play a significant role in the treatment of pancreatic cancer and we are pleased to be bringing Optune PACs to pancreatic cancer patients.
Speaker #3: The early days of our Optune PACs commercial launch have been encouraging. We received FDA approval on February 11th, and the seven weeks between the approval and quarter end, we certified 868 healthcare providers, 27 of whom are prescribers in academic centers, and exciting development has historically seen slower adoption of TT Fields therapy in academic centers.
William Doyle: In the 7 weeks between the approval and quarter end, we certified 868 healthcare providers, 27 of whom are prescribers in academic centers, an exciting development as historically we've seen slower adoption of TTFields therapy in academic centers. Through 31 March, we've received 169 prescriptions and completed 90 patient starts. We ended the quarter with 83 patients on therapy and a backlog of starts in the funnel. We are also pleased to report our first major payer coverage policy for Optune Pax with Elevance Health, covering over 30 million lives. It will take a few quarters to fully understand the Optune Pax adoption curve and reimbursement dynamics, but again, the early signals are very encouraging. During the quarter, we also announced top-line data from the phase 2 PANOVA-4 trial evaluating TTFields therapy together with atezolizumab and gemcitabine in metastatic pancreatic cancer.
Bill Doyle: In the 7 weeks between the approval and quarter end, we certified 868 healthcare providers, 27 of whom are prescribers in academic centers, an exciting development as historically we've seen slower adoption of TTFields therapy in academic centers. Through 31 March, we've received 169 prescriptions and completed 90 patient starts. We ended the quarter with 83 patients on therapy and a backlog of starts in the funnel. We are also pleased to report our first major payer coverage policy for Optune Pax with Elevance Health, covering over 30 million lives. It will take a few quarters to fully understand the Optune Pax adoption curve and reimbursement dynamics, but again, the early signals are very encouraging. During the quarter, we also announced top-line data from the phase 2 PANOVA-4 trial evaluating TTFields therapy together with atezolizumab and gemcitabine in metastatic pancreatic cancer.
Speaker #3: Through March 31, we've received 169 prescriptions and completed 90 patient starts. We ended the quarter with 83 patients on therapy and a backlog of starts in the funnel.
Speaker #3: We are also pleased to report our first major payer coverage policy for Optune PACs with Elevance Health, covering over $30 million lives. We will take a few quarters to fully understand the Optune PACs adoption curve and reimbursement dynamics, but again, the early signals are very encouraging.
Speaker #3: During the quarter, we also announced top-line data from the Phase 2 PANOVA-4 trial evaluating TTFields therapy together with atezolizumab and Gemzar/Abraxane in metastatic pancreatic cancer.
Speaker #3: Panova 4 met its primary endpoint with a disease control rate of 74% compared to 48% in the historical control. Median duration of therapy was 25.6 weeks, a strong indication that TT Fields therapy is feasible for use in the metastatic population.
William Doyle: PANOVA-4 met its primary endpoint with a disease control rate of 74% compared to 48% in the historical control. Median duration of therapy was 25.6 weeks, a strong indication that TTFields therapy is feasible for use in the metastatic population. As the pancreatic cancer treatment landscape evolves, we will evolve with it. After years of limited clinical success in pancreatic cancer, the medical community has seen positive outcomes in the PANOVA-3 and PANOVA-4 trials, and positive data from a trial testing the pan-RAS inhibitor, daraxonrasib, in second line metastatic pancreatic cancer. RAS inhibitors are likely to be an important backbone therapy in pancreatic cancer in the future, and we are working to understand the benefits of their concomitant use with Tumor Treating Fields.
Bill Doyle: PANOVA-4 met its primary endpoint with a disease control rate of 74% compared to 48% in the historical control. Median duration of therapy was 25.6 weeks, a strong indication that TTFields therapy is feasible for use in the metastatic population. As the pancreatic cancer treatment landscape evolves, we will evolve with it. After years of limited clinical success in pancreatic cancer, the medical community has seen positive outcomes in the PANOVA-3 and PANOVA-4 trials, and positive data from a trial testing the pan-RAS inhibitor, daraxonrasib, in second line metastatic pancreatic cancer. RAS inhibitors are likely to be an important backbone therapy in pancreatic cancer in the future, and we are working to understand the benefits of their concomitant use with Tumor Treating Fields.
Speaker #3: As the pancreatic cancer treatment landscape evolves, we will evolve with it. After years of limited clinical success in pancreatic cancer, the medical community has seen positive outcomes in the Panova 3 and Panova 4 trials and positive data from a trial testing the PanRAS inhibitor, duraxonaracid, in second-line metastatic pancreatic cancer.
Speaker #3: RAS inhibitors are likely to be an important backbone therapy in pancreatic cancer in the future, and we are working to understand the benefits of their concomitant use with tumor treating fields.
Speaker #3: Earlier this month, at the American Association of Cancer Research, or AACR, annual congress, two posters were presented which evaluated in vitro and in vivo use of TT Fields with duraxonaracid in pancreatic cancer models.
William Doyle: Earlier this month, at the American Association for Cancer Research, or AACR Annual Congress, two posters were presented which evaluated in vitro and in vivo use of TTFields with daraxonrasib in pancreatic cancer models. The data presented show that KRAS inhibition, which blocks upstream oncogenic signaling, and the downregulation of the c-Myc protein caused by TTFields, produced greater antitumor activity when used together compared to either therapy used alone. These data are promising, warrant clinical investigation, and will be important inputs as we consider the next steps in our pancreatic cancer program. Finally, a quick update on our product development initiatives. Over the last year, we've launched a number of product enhancements aimed at making TTFields therapy easier for patients and prescribers.
Bill Doyle: Earlier this month, at the American Association for Cancer Research, or AACR Annual Congress, two posters were presented which evaluated in vitro and in vivo use of TTFields with daraxonrasib in pancreatic cancer models. The data presented show that KRAS inhibition, which blocks upstream oncogenic signaling, and the downregulation of the c-Myc protein caused by TTFields, produced greater antitumor activity when used together compared to either therapy used alone. These data are promising, warrant clinical investigation, and will be important inputs as we consider the next steps in our pancreatic cancer program. Finally, a quick update on our product development initiatives. Over the last year, we've launched a number of product enhancements aimed at making TTFields therapy easier for patients and prescribers.
Speaker #3: The data presented show that KRAS inhibition, which blocks upstream oncogenic signaling, and the downregulation of the CMYK protein caused by TTFields produce greater anti-tumor activity when used together, compared to either therapy used alone.
Speaker #3: These data are promising, warrant clinical investigation, and will be important inputs as we consider the next steps in our pancreatic cancer program. Finally, a quick update on our product development initiatives.
Speaker #3: Over the last year, we've launched a number of product enhancements aimed at making TT Fields therapy easier for patients and prescribers. This includes an HCP portal, which simplifies the prescription process, lighter, more flexible, more comfortable HFEREs arrays, for Optune-Gia, a mobile app to help patients and caregivers navigate their TT Fields experience.
William Doyle: This includes an HCP portal, which simplifies the prescription process, lighter, more flexible, more comfortable HFE arrays for Optune Gio, a mobile app to help patients and caregivers navigate their TTFields experience. We are starting to see the fruits of these enhancements in our 90-day persistent rate, which hovered below 70% as recently as 2024. In 2025, we have seen quarterly persistent rates tick up to 73%. Our next major product improvement will be a new array for the torso. We are now finalizing the design, which will be compatible with Optune Pax and Optune Lua. The new arrays are designed to make major improvements in comfort and usability. We also expect these arrays to be more cost-effective to manufacture. We have completed usability testing in healthy volunteers and are evaluating performance in non-small cell lung cancer patients.
Bill Doyle: This includes an HCP portal, which simplifies the prescription process, lighter, more flexible, more comfortable HFE arrays for Optune Gio, a mobile app to help patients and caregivers navigate their TTFields experience. We are starting to see the fruits of these enhancements in our 90-day persistent rate, which hovered below 70% as recently as 2024. In 2025, we have seen quarterly persistent rates tick up to 73%. Our next major product improvement will be a new array for the torso. We are now finalizing the design, which will be compatible with Optune Pax and Optune Lua. The new arrays are designed to make major improvements in comfort and usability. We also expect these arrays to be more cost-effective to manufacture. We have completed usability testing in healthy volunteers and are evaluating performance in non-small cell lung cancer patients.
Speaker #3: We are starting to see the fruits of these enhancements in our 90-day persistent rate, which hovered below 70% as recently as 2024. In 2025, we have seen quarterly persistent rates tick up to 73%.
Speaker #3: Our next major product improvement will be a new array for the torso. We are now finalizing the design, which will be compatible with Optune PACs and Optune LUA.
Speaker #3: The new arrays are designed to make major improvements in comfort and usability. We also expect these arrays to be more cost-effective to manufacture. We have completed usability testing in healthy volunteers and are evaluating performance in non-small cell lung cancer patients.
Speaker #3: Our next aim is to have the new arrays available for use in future pancreatic and lung cancer clinical trials by year-end. I'll now pass the call over to Frank for an update on our GBM and lung cancer programs.
William Doyle: Our next aim is to have the new arrays available for use in future pancreatic and lung cancer clinical trials by year-end. I'll now pass the call over to Frank for an update on our GBM and lung cancer programs.
Bill Doyle: Our next aim is to have the new arrays available for use in future pancreatic and lung cancer clinical trials by year-end. I'll now pass the call over to Frank for an update on our GBM and lung cancer programs.
Speaker #4: Thank you, Bill. Our Optune Gio business remains the core driver of our commercial portfolio. We are off to a strong start to the year with 9% year-over-year growth in active patients globally.
Frank Leonard: Thank you, Bill. Our Optune Gio business remains the core driver of our commercial portfolio. We are off to a strong start to the year, with 9% year-over-year growth in active patients globally. We saw our strongest growth in Japan, Germany, and France, which contributed 20%, 12%, and 9% year-over-year active patient growth, respectively. Our global market segment also had an outstanding quarter with 17% active patient growth, driven by a promising launch in Spain. We believe we can maintain low to mid-single digit active patient growth in our mature markets and even higher growth in new markets like Spain and Czechia. The next major catalyst in our GBM program will be top-line data from the phase 3 TRIDENT trial expected in Q2. The TRIDENT results will provide us with a better understanding of how TTFields can work with radiation therapy.
Frank Leonard: Thank you, Bill. Our Optune Gio business remains the core driver of our commercial portfolio. We are off to a strong start to the year, with 9% year-over-year growth in active patients globally. We saw our strongest growth in Japan, Germany, and France, which contributed 20%, 12%, and 9% year-over-year active patient growth, respectively. Our global market segment also had an outstanding quarter with 17% active patient growth, driven by a promising launch in Spain. We believe we can maintain low to mid-single digit active patient growth in our mature markets and even higher growth in new markets like Spain and Czechia. The next major catalyst in our GBM program will be top-line data from the phase 3 TRIDENT trial expected in Q2. The TRIDENT results will provide us with a better understanding of how TTFields can work with radiation therapy.
Speaker #4: We saw our strongest growth in Japan, Germany, and France, which contributed 20%, 12%, and 9% year-over-year active patient growth, respectively. Our global market segment also had an outstanding quarter with 17% active patient growth, driven by a promising launch in Spain.
Speaker #4: We believe we can maintain low to mid-single-digit active patient growth in our mature markets, and even higher growth in new markets like Spain and Czechia.
Speaker #4: The next major catalyst in our GBM program will be top-line data from the Phase 3 Trident trial, expected in the second quarter. The Trident results will provide us with a better understanding of how TT Fields can work with radiation therapy.
Speaker #4: Trident moves the start of Optune Gio earlier in the GBM treatment journey, beginning with chemoradiation rather than following chemoradiation. In Trident, the patient population eligible for inclusion is broader than our EF-14 trial.
Frank Leonard: TRIDENT moves the start of Optune Gio earlier in the GBM treatment journey, beginning with chemoradiation rather than following chemoradiation. In TRIDENT, the patient population eligible for inclusion is broader than our EF14 trial. In the EF14 trial, patients who progressed in the short time between chemoradiation and screening were not eligible for randomization. In the TRIDENT trial, where randomization occurs prior to the start of chemoradiation, we are able to assess the use of TTFields in this previously ineligible cohort. We expect TRIDENT to give further insight into whether earlier use of TTFields therapy can drive additional survival benefit to a broader population of eligible patients. Turning now to Optune Lua. In March, we received national reimbursement in Japan and began treating commercial patients.
Frank Leonard: TRIDENT moves the start of Optune Gio earlier in the GBM treatment journey, beginning with chemoradiation rather than following chemoradiation. In TRIDENT, the patient population eligible for inclusion is broader than our EF14 trial. In the EF14 trial, patients who progressed in the short time between chemoradiation and screening were not eligible for randomization. In the TRIDENT trial, where randomization occurs prior to the start of chemoradiation, we are able to assess the use of TTFields in this previously ineligible cohort. We expect TRIDENT to give further insight into whether earlier use of TTFields therapy can drive additional survival benefit to a broader population of eligible patients. Turning now to Optune Lua. In March, we received national reimbursement in Japan and began treating commercial patients.
Speaker #4: In the EF-14 trial, patients who progressed in the short time between chemoradiation and screening were not eligible for randomization. In the TRIDENT trial, where randomization occurs prior to the start of chemoradiation, we are able to assess the use of TTFields in this previously ineligible cohort.
Speaker #4: We expect Trident to give further insight into whether earlier use of TT Fields therapy can drive additional survival benefit to a broader population of eligible patients.
Speaker #4: Turning now to Optune LUA, in March, we received national reimbursement in Japan and began treating commercial patients. Japan provides a promising market for Optune LUA as our lunar clinical trial data more closely reflect the standard of care in Japan.
Frank Leonard: Japan provides a promising market for Optune Lua as our LUNAR clinical trial data more closely reflect the standard of care in Japan. On 15 March, we hosted a symposium with approximately 250 Japanese lung cancer physicians in attendance, including a number of leading key opinion leaders. We are in the early stages of our launch, but we are encouraged by the physician interest and engagement thus far. On the clinical trial front, as I have said from the beginning of my tenure as CEO, we need to update our strategy for the LUNAR-2 trial. We are exploring options now to modify the trial with the goals of compressing the timeline to completion and significantly reducing the cost. We look forward to engaging with regulators to discuss the potential changes and providing a full update later this year.
Frank Leonard: Japan provides a promising market for Optune Lua as our LUNAR clinical trial data more closely reflect the standard of care in Japan. On 15 March, we hosted a symposium with approximately 250 Japanese lung cancer physicians in attendance, including a number of leading key opinion leaders. We are in the early stages of our launch, but we are encouraged by the physician interest and engagement thus far. On the clinical trial front, as I have said from the beginning of my tenure as CEO, we need to update our strategy for the LUNAR-2 trial. We are exploring options now to modify the trial with the goals of compressing the timeline to completion and significantly reducing the cost. We look forward to engaging with regulators to discuss the potential changes and providing a full update later this year.
Speaker #4: On March 15th, we hosted a symposium with approximately 250 Japanese lung cancer physicians in attendance, including a number of leading key opinion leaders. We are in the early stages of our launch, but we're encouraged by the physician interest and engagement thus far.
Speaker #4: On the clinical trial front, as I have said from the beginning of my tenure as CEO, we need to update our strategy for the Lunar 2 trial.
Speaker #4: We are exploring options now to modify the trial with the goals of compressing the timeline to completion and significantly reducing the cost. We look forward to engaging with regulators to discuss the potential changes and providing a full update later this year.
Speaker #4: Overall, this was a very strong quarter, and we are pleased with our progress. Our commercial focus is on expanding adoption in GBM, maintaining the momentum of our Optune PACs launch, and capturing value in the markets where Optune LUA potential is greatest.
Frank Leonard: Overall, this was a very strong quarter, and we are pleased with our progress. Our commercial focus is on expanding adoption in GBM, maintaining the momentum of our Optune Pax launch, and capturing value in the markets where Optune Lua potential is greatest. We've reached a number of exciting commercial and clinical milestones in Q1 and look forward to sharing more information on additional catalysts throughout the year. Christoph will now walk through our financial results from Q1.
Frank Leonard: Overall, this was a very strong quarter, and we are pleased with our progress. Our commercial focus is on expanding adoption in GBM, maintaining the momentum of our Optune Pax launch, and capturing value in the markets where Optune Lua potential is greatest. We've reached a number of exciting commercial and clinical milestones in Q1 and look forward to sharing more information on additional catalysts throughout the year. Christoph will now walk through our financial results from Q1.
Speaker #4: We've reached a number of exciting commercial and clinical milestones in the first quarter and look forward to sharing more information on additional catalysts throughout the year.
Speaker #4: Christoph will now walk through our financial results from Q1.
Speaker #5: Thank you, Frank, and thank you all for joining us this morning. We had a strong start to the year, continuing our momentum from 2025.
Christoph Brackmann: Thank you, Frank. Thank you all for joining us this morning. We had a strong start to the year, continuing our momentum from 2025. Net revenue in Q1 was $174 million, an increase of 12% year over year. The increase was driven primarily by continued growth in our markets outside the US, including increases of $6 million and $5 million from Germany and France, respectively. Germany benefited from increased approval rates, which provided a one-time benefit of $2.5 million, and France benefited from contract performance improvement, which provided a one-time benefit of $1 million. We also had a $5.6 million tailwind from changes in foreign exchange rates compared to Q1 2025.
Christoph Brackmann: Thank you, Frank. Thank you all for joining us this morning. We had a strong start to the year, continuing our momentum from 2025. Net revenue in Q1 was $174 million, an increase of 12% year over year. The increase was driven primarily by continued growth in our markets outside the US, including increases of $6 million and $5 million from Germany and France, respectively. Germany benefited from increased approval rates, which provided a one-time benefit of $2.5 million, and France benefited from contract performance improvement, which provided a one-time benefit of $1 million. We also had a $5.6 million tailwind from changes in foreign exchange rates compared to Q1 2025.
Speaker #5: Net revenue in the first quarter was 174 million dollars, an increase of 12% year-over-year. The increase was driven primarily by continued growth in our markets outside the US, including increases of 6 million and 5 million dollars from Germany and France respectively.
Speaker #5: Germany benefited from increased approval rates, which provided a one-time benefit of 2.5 million dollars, and France benefited from contract performance improvements, which provided a one-time benefit of 1 million dollars.
Speaker #5: We also had a 5.6 million dollar tailwind from changes in foreign exchange rates compared to Q1 2025. Net revenue from Optune LUA in the first quarter was 3 million dollars compared to 1.5 million dollars in Q1 2025.
Christoph Brackmann: Net revenue from Optune Lua in Q1 was $3 million compared to $1.5 million in Q1 2025. Based on the strength of our Q1 results in GBM, we are updating our full year revenue guidance to a range of $690 million to $710 million, representing 5% to 8% growth. We are maintaining the range for combined revenue from Optune Lua and Optune Pax at $15 million to $25 million for the year. Gross margin in the quarter was 78% compared to 75% in Q1 2025. This was primarily driven by lower costs for arrays, resulting from improved array utilization and lower supplier prices.
Christoph Brackmann: Net revenue from Optune Lua in Q1 was $3 million compared to $1.5 million in Q1 2025. Based on the strength of our Q1 results in GBM, we are updating our full year revenue guidance to a range of $690 million to $710 million, representing 5% to 8% growth. We are maintaining the range for combined revenue from Optune Lua and Optune Pax at $15 million to $25 million for the year. Gross margin in the quarter was 78% compared to 75% in Q1 2025. This was primarily driven by lower costs for arrays, resulting from improved array utilization and lower supplier prices.
Speaker #5: Based on the strength of our first quarter results in GBM, we are updating our full-year revenue guidance to a range of 690 million to 710 million dollars, representing 5% to 8% growth.
Speaker #5: We are maintaining the range for combined revenue from Optune LUA and Optune PACs at 15 million to 25 million dollars for the year. Gross margin in the quarter was 78% compared to 75% in Q1 of 2025.
Speaker #5: This was primarily driven by lower costs for arrays resulting from improved array utilization and lower supplier prices. We continue to expect annual gross margin in the mid-70s for the full year 2026 as we bring more Optune PACs patients on therapy prior to establishing broad reimbursement.
Christoph Brackmann: We continue to expect annual gross margin in the mid-70s for the full year 2026 as we bring more Optune Pax patients on therapy prior to establishing broad reimbursement. Research and development costs in the quarter were $58 million, an increase of 8% compared to the same period in 2025. This was primarily driven by increased costs associated with the KEYNOTE-D58 trial. As a reminder, this is a 700 plus patient trial, which we expect to fully enroll by the end of this year. Sales and marketing expenses in Q1 were $58 million, up 5% from Q1 2025. This was driven by launch costs for Optune Pax in the US and Optune Lua in Japan. G&A costs in the quarter were $86 million, up 92% from the same period last year.
Christoph Brackmann: We continue to expect annual gross margin in the mid-70s for the full year 2026 as we bring more Optune Pax patients on therapy prior to establishing broad reimbursement. Research and development costs in the quarter were $58 million, an increase of 8% compared to the same period in 2025. This was primarily driven by increased costs associated with the KEYNOTE-D58 trial. As a reminder, this is a 700 plus patient trial, which we expect to fully enroll by the end of this year. Sales and marketing expenses in Q1 were $58 million, up 5% from Q1 2025. This was driven by launch costs for Optune Pax in the US and Optune Lua in Japan. G&A costs in the quarter were $86 million, up 92% from the same period last year.
Speaker #5: Research and development costs in the quarter were 58 million dollars, an increase of 8% compared to the same period in 2025. This was primarily driven by increased costs associated with the keynote D58 trial, as a reminder, this is a 700-plus patient trial which we expect to fully involve by the end of this year.
Speaker #5: Sales and marketing expenses in Q1 were 58 million dollars, up 5% from Q1 2025. This was driven by launch costs for Optune PACs in the US and Optune LUA in Japan.
Speaker #5: G&A costs in the quarter were $86 million, up 92% from the same period last year. As we mentioned last quarter, we incurred a $43 million share-based compensation charge triggered by the approval of Optune PACs.
Christoph Brackmann: As we mentioned last quarter, we incurred a $43 million share-based compensation charge triggered by the approval of Optune Pax. I do want to note this expense is included for GAAP accounting purposes, and the grant associated with this charge did not vest and shares were not distributed. Our net loss for the quarter was $71 million compared to $34 million in Q1 2025. Excluding the one-time share-based compensation expense, net loss was $28 million. Loss per share in the quarter was -$0.62. Adjusted EBITDA in the quarter was -$0.3 million compared to -$5 million in Q1 2025. We are updating our full-year Adjusted EBITDA guidance this morning to a range from -$15 million to break even.
Christoph Brackmann: As we mentioned last quarter, we incurred a $43 million share-based compensation charge triggered by the approval of Optune Pax. I do want to note this expense is included for GAAP accounting purposes, and the grant associated with this charge did not vest and shares were not distributed. Our net loss for the quarter was $71 million compared to $34 million in Q1 2025. Excluding the one-time share-based compensation expense, net loss was $28 million. Loss per share in the quarter was -$0.62. Adjusted EBITDA in the quarter was -$0.3 million compared to -$5 million in Q1 2025. We are updating our full-year Adjusted EBITDA guidance this morning to a range from -$15 million to break even.
Speaker #5: I do want to note this expense is included for GAAP accounting purposes and the grant associated with this charge did not vest in shares were not distributed.
Speaker #5: Our net loss for the quarter was 71 million compared to 34 million dollars in Q1 2025. Excluding the one-time share-based compensation expense, net loss was 28 million dollars.
Speaker #5: Loss per share in the quarter was negative $0.62. Adjusted EBITDA in the quarter was negative $0.3 million, compared to negative $5 million in the first quarter of 2025.
Speaker #5: We are updating our full-year adjusted EBITDA guidance this morning to a range from negative 15 million dollars to breakeven. This reflects our strong start to the year as well as accelerated expenses from our Optune PACs launch.
Christoph Brackmann: This reflects our strong start to the year, as well as accelerated expenses from our Optune Pax launch. Our cash and investment balance as of 31 March 2026 was $432 million. Thank you all for joining us this morning. We will now open the line for Q&A.
Christoph Brackmann: This reflects our strong start to the year, as well as accelerated expenses from our Optune Pax launch. Our cash and investment balance as of 31 March 2026 was $432 million. Thank you all for joining us this morning. We will now open the line for Q&A.
Speaker #5: Our cash and investment balance as of March 31, 2026, was was 432 million dollars. Thank you all for joining us this morning. We will now open the line for Q&A.
Speaker #1: Certainly. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.
Operator 2: Certainly. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile our Q&A roster. Our first question will be coming from Jonathan Chang of Leerink Partners. Your line is open, Jonathan.
Operator: Certainly. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile our Q&A roster. Our first question will be coming from Jonathan Chang of Leerink Partners. Your line is open, Jonathan.
Speaker #1: Please stand by while we compile our Q&A roster. And our first question will be coming from Jonathan Chang of Lerank Partners. Your line is open, Jonathan.
Speaker #6: Hi guys, good morning, and thanks for taking my questions. Team providing more color on the early Optune PACs launch at the number of prescribers, the types of centers where you're seeing utilization, the early clinician-patient feedback, and help us contextualize how does this compare to the early lung cancer launch experience.
Jonathan Chang: Hi, guys. Good morning, and thanks for taking my questions. Can you provide any more color on the early Optune Pax launch, like the number of prescribers, the types of centers where you're seeing utilization, the early clinician-patient feedback, and help us contextualize how does this compare to the early lung cancer launch experience? Thank you.
Jonathan Chang: Hi, guys. Good morning, and thanks for taking my questions. Can you provide any more color on the early Optune Pax launch, like the number of prescribers, the types of centers where you're seeing utilization, the early clinician-patient feedback, and help us contextualize how does this compare to the early lung cancer launch experience? Thank you.
Speaker #6: Thank
Speaker #4: Thanks, Jonathan. Appreciate the question. We are seeing we're really proud of the Optune PACs launch, both our preparation and also the response from the market.
Frank Leonard: Thanks, Jonathan. Appreciate the question. You know, we are seeing, we're really proud of the Optune Pax launch, both our preparation and also the response from the market. As Bill mentioned in his opening remarks, we had over 800 certified prescribers in just the opening month essentially of approval. As Bill mentioned, 27% of the certified prescribers are from academic centers. While we haven't given specific statistics on the number of prescribers who actually wrote in Q1, I will say that we were pleased it was a breadth across both community and academic centers, as well as prescribers who even in the first five weeks wrote multiple prescriptions.
Frank Leonard: Thanks, Jonathan. Appreciate the question. You know, we are seeing, we're really proud of the Optune Pax launch, both our preparation and also the response from the market. As Bill mentioned in his opening remarks, we had over 800 certified prescribers in just the opening month essentially of approval. As Bill mentioned, 27% of the certified prescribers are from academic centers. While we haven't given specific statistics on the number of prescribers who actually wrote in Q1, I will say that we were pleased it was a breadth across both community and academic centers, as well as prescribers who even in the first five weeks wrote multiple prescriptions.
Speaker #4: As Bill mentioned in his opening remarks, we had over 800 certified prescribers in just the opening month, essentially, of approval. And as Bill mentioned, 27% of the certified prescribers are from academic centers.
Speaker #4: And while we haven't given specific statistics on the number of prescribers who actually wrote in the first quarter, I will say that we were pleased it was a breadth across both community and academic centers, as well as prescribers who, even in the first five weeks, wrote multiple prescriptions.
Speaker #4: So I think as we get into the second quarter, we will be able to give a little bit more color on that quantitative color on the prescribing trends and who's prescribing and where.
Frank Leonard: I think as we get into the Q2, we will be able to give a little bit more color on that, quantitative color on the prescribing trends and who's prescribing and where. In terms of just the aggregate demand experienced in the first month of launch, we're very pleased. To your question about how this compares to our lung launch, we would, you know, say this is, you know, across whatever metric we want to look at it, is multiples of demand and really just a significantly different reception from the prescribing community.
Frank Leonard: I think as we get into the Q2, we will be able to give a little bit more color on that, quantitative color on the prescribing trends and who's prescribing and where. In terms of just the aggregate demand experienced in the first month of launch, we're very pleased. To your question about how this compares to our lung launch, we would, you know, say this is, you know, across whatever metric we want to look at it, is multiples of demand and really just a significantly different reception from the prescribing community.
Speaker #4: But in terms of just the aggregate demand experienced in the first month of launch, we're very pleased and to your question about how this compares to our lung launch, we would say this is across whatever metric we want to look at, it is multiple of demand and really just a significantly different reception from the prescribing community.
Jonathan Chang: Understood. Thanks for taking my questions.
Jonathan Chang: Understood. Thanks for taking my questions.
Speaker #6: Understood. Thanks for taking my questions.
Operator 2: Our next question will be coming from the line of Jason Bednar of Piper Sandler. Your line is open, Jason.
Speaker #1: And our next question will be coming from the line of Jason Bedner, of Piper Sandler. Your line is open, Jason.
Operator: Our next question will be coming from the line of Jason Bednar of Piper Sandler. Your line is open, Jason.
Speaker #4: Thanks. Good morning, everyone. Congrats, and a really nice quarter here and a start with Optune PACs. So I'll start there. The launch here is significantly better than what we were thinking, just really nice to see.
Jason Bednar: Thanks. Good morning, everyone. Congrats on a really nice quarter here, and let's start with Optune Pax. I'll start there. The launch here is significantly better than what we were thinking. Just really nice to see. Wondering if you could expand a bit more on those results, where you're at with physician onboarding versus the prescribing process. I guess what I mean there is your early metrics are so strong, it has me wondering about the steps of converting certified prescribers into active prescribers. Are those prescribers predominantly, you know, those that were part of your trial, and that's why they were able to move so quickly with prescriptions? Just any color you can add here as we think about the launch curve after physicians are certified and then moving into that prescribing of Pax.
Jason Bednar: Thanks. Good morning, everyone. Congrats on a really nice quarter here, and let's start with Optune Pax. I'll start there. The launch here is significantly better than what we were thinking. Just really nice to see. Wondering if you could expand a bit more on those results, where you're at with physician onboarding versus the prescribing process. I guess what I mean there is your early metrics are so strong, it has me wondering about the steps of converting certified prescribers into active prescribers. Are those prescribers predominantly, you know, those that were part of your trial, and that's why they were able to move so quickly with prescriptions? Just any color you can add here as we think about the launch curve after physicians are certified and then moving into that prescribing of Pax.
Speaker #4: Wondering if you could expand a bit more on those results, where you're at with physician onboarding versus the prescribing process. And I guess what I mean there is your early metrics are so strong, it has me wondering about the steps of converting certified prescribers into active prescribers.
Speaker #4: Are those prescribers predominantly those that were part of your trial and that's why they were able to move so quickly with prescriptions? Just any color you can add here as we think about the launch curve after physicians are certified and then moving into that prescribing of PACs.
Frank Leonard: Jason, thank you. Appreciate the question. You know what I would say is the, to your question sort of around who are those initial prescribers, I would actually start by just referencing back to the fact that this is the first significant approval for this indication. It is really, if we look just to the stage of locally advanced pancreatic cancer, this is the first successful trial. In that space. While we've seen very strong engagement from the PIs who participated in the trial, the interest is much broader. It was, you know, essentially a build-up of demand that we were able to meet at centers we've never worked with before.
Frank Leonard: Jason, thank you. Appreciate the question. You know what I would say is the, to your question sort of around who are those initial prescribers, I would actually start by just referencing back to the fact that this is the first significant approval for this indication. It is really, if we look just to the stage of locally advanced pancreatic cancer, this is the first successful trial. In that space. While we've seen very strong engagement from the PIs who participated in the trial, the interest is much broader. It was, you know, essentially a build-up of demand that we were able to meet at centers we've never worked with before.
Speaker #3: Jason, thank you. I appreciate the question. What I would say is, to your question, sort of around who are those initial prescribers, I would actually start by just referencing back to the fact that this is the first significant approval for this indication.
Speaker #3: It's really if we look just to the stage of locally advanced pancreatic cancer, this is the first successful trial. In that space. And so while we've seen very strong engagement from the PIs who participated in the trial, the interest is much broader.
Speaker #3: And it was essentially a build-up of demand that we were able to meet at centers we've never worked with before. Academic centers where we've previously had very difficult times gaining access wanted to have us in there in the first week so that they could immediately add to the standard of care.
Frank Leonard: Academic centers where we've previously had, you know, very difficult times gaining access, wanted to have us in there in the first week so that they could immediately add to the standard of care. You know, I think we'll really go into some more numbers as we move forward into the next quarters, but it's again, I would say this is very broad-based. There's not one single cohort that was able to go first. You know, more on that process to remind everyone, as a device, we do have to train and certify our physicians as a first step. Once that training and certification takes place, they're able to prescribe right away. Those who have worked with us before might be a little bit more sophisticated about how to transfer prescriptions to us.
Frank Leonard: Academic centers where we've previously had, you know, very difficult times gaining access, wanted to have us in there in the first week so that they could immediately add to the standard of care. You know, I think we'll really go into some more numbers as we move forward into the next quarters, but it's again, I would say this is very broad-based. There's not one single cohort that was able to go first. You know, more on that process to remind everyone, as a device, we do have to train and certify our physicians as a first step. Once that training and certification takes place, they're able to prescribe right away. Those who have worked with us before might be a little bit more sophisticated about how to transfer prescriptions to us.
Speaker #3: So I think we'll really go into some more numbers as we move forward in the next quarters, but it's, again, I would say this is very broad-based.
Speaker #3: There's not one single cohort that was able to go first. And more on that process to remind everyone, as a device, we do have to train and certify our physicians as a first step.
Speaker #3: Once that training and certification takes place, they're able to prescribe right away. Those who have worked with us before might be a little bit more sophisticated about how to transfer prescriptions to us.
Frank Leonard: What I'm also really pleased to say is we've made significant investments over the last year into our HCP portal, the ways in which we work with physicians to transfer the prescription and the related data that's required, such that I think we've lowered the bar, in terms of the burden on the physician, and as a result, we've seen that speed to prescribe.
Speaker #3: But what I'm also really pleased to say is we've made significant investments over the last year into our HCP portal, the ways in which we work with physicians to transfer the prescription and the related data that's required, such that I think we've lowered the bar in terms of the burden on the physician.
Frank Leonard: What I'm also really pleased to say is we've made significant investments over the last year into our HCP portal, the ways in which we work with physicians to transfer the prescription and the related data that's required, such that I think we've lowered the bar, in terms of the burden on the physician, and as a result, we've seen that speed to prescribe.
Speaker #3: And as a result, we've seen that speed to prescribe.
Speaker #4: Yeah, and the only thing I'd add is the enthusiasm really started to build at ASCO last year when the data were first presented. We saw just a great reception from the podium.
William Doyle: Yeah. The only thing I'd add is the enthusiasm really started to build at ASCO last year when the data were first presented. We saw, you know, just a great reception from the podium. You know, to your specific question, the interest has certainly had an opportunity to build and was far broader than the investigators.
Bill Doyle: Yeah. The only thing I'd add is the enthusiasm really started to build at ASCO last year when the data were first presented. We saw, you know, just a great reception from the podium. You know, to your specific question, the interest has certainly had an opportunity to build and was far broader than the investigators.
Speaker #4: And so to your specific question, the interest is certainly had an opportunity to build and was far broader than the investigators. Okay, excellent. Maybe one quick follow-up and then a separate one on guidance.
Jason Bednar: Okay. Excellent. Maybe one quick follow-up and then a separate one on guidance. The quick follow-up, just as we think about that launch curve, you've been in market here for now 3 months or, you know, almost 3 months. What does that look like in February to March to April? If you can share any real-time feedback on that launch trajectory. Separately on the guidance question, you know, for revenue, you bumped the midpoint by $10 million. You beat consensus by $6 million. That's a pretty strong statement out of the gate here. Maybe talk about, if you could, what you're seeing real time or over the balance of the year that left you comfortable raising the revenue guide by more than the beat.
Jason Bednar: Okay. Excellent. Maybe one quick follow-up and then a separate one on guidance. The quick follow-up, just as we think about that launch curve, you've been in market here for now 3 months or, you know, almost 3 months. What does that look like in February to March to April? If you can share any real-time feedback on that launch trajectory. Separately on the guidance question, you know, for revenue, you bumped the midpoint by $10 million. You beat consensus by $6 million. That's a pretty strong statement out of the gate here. Maybe talk about, if you could, what you're seeing real time or over the balance of the year that left you comfortable raising the revenue guide by more than the beat.
Speaker #4: But the quick follow-up, just as we think about that launch curve, you've been in market here for now three months or almost three months.
Speaker #4: What does that look like in February to March to April, if you can share any real-time feedback on that launch trajectory? And then separately on the guidance question, for revenue, you bumped the midpoint by 10 million.
Speaker #4: You beat consensus by $6 million, so that's a pretty strong statement out of the gate here. Maybe talk about, if you could, what you're seeing real-time or over the balance of the year that left you comfortable raising the revenue guide by more than the beat.
Frank Leonard: Jason, thank you. I'll comment on the trajectory and then pass to Christoph. Sorry, to Christoph. We, you know, we can't comment on the trajectory in the current quarter, only on the prior quarter. I would just say that when you look at the, there's, you know, FDA approval, then there's a bit of time where we have to refile our labeling with the FDA. You look at the last quarter really in the context of essentially four weeks in market. I'd go back to what I said before, that we were very pleased by the results. We, you know, see real strength in that, you know, that initial interaction with our customers, and we are very excited for the rest of the year in terms of continuing the momentum.
Frank Leonard: Jason, thank you. I'll comment on the trajectory and then pass to Christoph. Sorry, to Christoph. We, you know, we can't comment on the trajectory in the current quarter, only on the prior quarter. I would just say that when you look at the, there's, you know, FDA approval, then there's a bit of time where we have to refile our labeling with the FDA. You look at the last quarter really in the context of essentially four weeks in market. I'd go back to what I said before, that we were very pleased by the results. We, you know, see real strength in that, you know, that initial interaction with our customers, and we are very excited for the rest of the year in terms of continuing the momentum.
Speaker #3: Jason, thank you. I'll comment on the trajectory and then pass to Christoph. We can't comment on the trajectory in the current quarter, only on the prior quarter.
Speaker #3: I would just say that when you look at the there was FDA approval, then there's a bit of time where we have to refile our labeling with the FDA.
Speaker #3: And you look at the last quarter really in the context of essentially four weeks in market, I'd go back to what I said before that we were very pleased by the results.
Speaker #3: We see real strength in that initial interaction with our customers and we are very excited for the rest of the year in terms of continuing the momentum.
Speaker #4: Yeah. And Jason, Christoph here. So, to your guidance question, I would say we came off the back of a very strong 2025 and also Q4.
Christoph Brackmann: Yeah. Jason, Christoph here. To your guidance question, I would say we came off the back of a very strong 2025 and also Q4. We have seen in Q1 that we were able to carry that momentum into 2026, which gave us the confidence, combined with the strong revenue also in Q1, to increase the guidance to what we have seen, $690 to 710 million.
Christoph Brackmann: Yeah. Jason, Christoph here. To your guidance question, I would say we came off the back of a very strong 2025 and also Q4. We have seen in Q1 that we were able to carry that momentum into 2026, which gave us the confidence, combined with the strong revenue also in Q1, to increase the guidance to what we have seen, $690 to 710 million.
Speaker #4: And we have seen in Q1 that we were able to carry that momentum into 2026, which gave us the confidence combined with the strong revenue also in Q1 to increase the guidance.
Speaker #4: To what you've seen, 690 to 710 million.
Jason Bednar: Okay. Thanks again. Congrats.
Jason Bednar: Okay. Thanks again. Congrats.
Speaker #6: Okay. Thanks again. Congrats.
Operator 2: Our next question will be coming from Kevin DeGeeter of Ladenburg Thalmann. Your line is open, Kevin.
Speaker #1: And our next question will be coming from Kevin DeJeter of Leidenburg Baumann. Your line is open, Kevin.
Operator: Our next question will be coming from Kevin DeGeeter of Ladenburg Thalmann. Your line is open, Kevin.
Kevin DeGeeter: Yeah.
Kevin DeGeeter: Yeah.
Speaker #7: Yep. Congratulations on the great quarter. Specifically, can you comment on kind of what you're seeing in terms of your funnel for contracting and coverage with some of the commercial payers and provide any updated thoughts on engagement and potential for CMS coverage for and this is for Ocuflox.
Kevin DeGeeter: Congratulations on the great quarter can reimburse the payer. Specifically, can you comment on kind of what you're seeing in terms of your funnel for contracting and coverage with some of the commercial payers and provide any updated thoughts on engagement and potential or CMS coverage for, and this is for Optune Pax?
Kevin DeGeeter: Congratulations on the great quarter can reimburse the payer. Specifically, can you comment on kind of what you're seeing in terms of your funnel for contracting and coverage with some of the commercial payers and provide any updated thoughts on engagement and potential or CMS coverage for, and this is for Optune Pax?
Frank Leonard: Sorry, Kevin. I think we were getting a little bit of a break up as you were speaking. I believe the question was directed towards our pathway to coverage and reimbursement for Optune Pax in the United States. I'll start by highlighting we're very pleased to have our first major payer in the United States covering Optune Pax with the coverage policy from Cigna. We will continue to work through the reimbursement process with the other major payers, private payers in the US. What we've typically said is that we expect around one year to two years to work through a coverage process in the US for private payers, and more on that full two-year window to have a revision to the LCD for the Medicare coverage.
Frank Leonard: Sorry, Kevin. I think we were getting a little bit of a break up as you were speaking. I believe the question was directed towards our pathway to coverage and reimbursement for Optune Pax in the United States. I'll start by highlighting we're very pleased to have our first major payer in the United States covering Optune Pax with the coverage policy from Cigna. We will continue to work through the reimbursement process with the other major payers, private payers in the US. What we've typically said is that we expect around one year to two years to work through a coverage process in the US for private payers, and more on that full two-year window to have a revision to the LCD for the Medicare coverage.
Speaker #8: Sorry, Kevin. I think we were getting a little bit of a breakup as you were speaking. But I believe the question was directed towards our pathway to coverage and reimbursement for Optune PACs in the United States.
Speaker #8: I'll start by highlighting we're very pleased to have our first major payer in the United States, covering Optum PACs with the coverage policies from Alabama.
Speaker #8: And we will continue to work through the reimbursement process with the other major payers, private payers in the US, what we've typically said is that we expect around a year to two years to work through a coverage process in the US for private payers.
Speaker #8: And more on that full two-year window to have a revision to the LCD for the Medicare coverage. In terms of contracting, we have existing contracts in place with most payers in the United States.
Frank Leonard: In terms of contracting, we have existing contracts in place with most payers in the United States, so we actually do not have a contracting step on PAX. Once a coverage policy is issued, the reimbursement is in place on the private side. Lastly, I'll just close by noting, you know, we do view NCCN guideline inclusion as an important step, and we are continuing. You know, we have filed with the NCCN to request that guideline inclusion, and we are monitoring the situation closely.
Frank Leonard: In terms of contracting, we have existing contracts in place with most payers in the United States, so we actually do not have a contracting step on PAX. Once a coverage policy is issued, the reimbursement is in place on the private side. Lastly, I'll just close by noting, you know, we do view NCCN guideline inclusion as an important step, and we are continuing. You know, we have filed with the NCCN to request that guideline inclusion, and we are monitoring the situation closely.
Speaker #8: So we actually do not have a contracting step on PACs. So once a coverage policy is issued, the reimbursement is in place on the private side.
Speaker #8: Lastly, I'll just close by noting we do have a we do view NCCN guideline inclusion as an important step. And we are continuing to we have filed with the NCCN to request that guideline inclusion.
Speaker #8: And we are monitoring the situation closely.
Speaker #1: And our next question. We'll be coming from the line of Vijay Kumar of Evercore ISI. Your line is open.
Operator 2: Our next question will be coming from the line of Vijay Kumar of Evercore ISI. Your line is open.
Operator: Our next question will be coming from the line of Vijay Kumar of Evercore ISI. Your line is open.
Vijay Kumar: Hi, team. Congrats on a nice print here, and thank you for taking my question. I guess, Bill or Frank, my first one was on, you know, this pancreatic, you know, RAS inhibitors. I'm curious on, just to be clear, right? I think Revolution Medicines had some good data. Just to be very clear, their approval is not a headwind to your Optune Pax, correct? Because, you know, correct me if I'm wrong, the indications for your trial are very different versus Revolution Medicines. Could you just clarify that, please?
Vijay Kumar: Hi, team. Congrats on a nice print here, and thank you for taking my question. I guess, Bill or Frank, my first one was on, you know, this pancreatic, you know, RAS inhibitors. I'm curious on, just to be clear, right? I think Revolution Medicines had some good data. Just to be very clear, their approval is not a headwind to your Optune Pax, correct? Because, you know, correct me if I'm wrong, the indications for your trial are very different versus Revolution Medicines. Could you just clarify that, please?
Speaker #9: Hi, team. Congrats on a nice sprint here and thank you for taking my question. I guess Bill or Frank, my first one was on this pancreatic noted RAS inhibitors.
Speaker #9: I'm curious on just to be clear, right? I think Revolution Medicine had some good data just to be very clear their approval is not a headwind to your to PACs, correct?
Speaker #9: Because correct me if I'm wrong, the indications for your trial are very different versus Revolution Medicine. Could you just clarify that, please?
Speaker #8: Thank you. Vijay, thank you very much. I think and thank you for the question. We are when we think about Optum PACs and TT fields for pancreatic cancer, I always want to highlight back to the fact that pancreatic tumors have a low bioavailability for drugs, which is a big reason for why so many drugs have failed in this indication in clinical trials.
Frank Leonard: Thank you. Vijay, thank you very much. Thank you, and thank you for the question. You know, when we think about Optune Pax and TTFields for pancreatic cancer, I always want to highlight back to the fact that pancreatic tumors have a low bioavailability for drugs, which is a big reason for why so many drugs have failed in this indication in clinical trials. It's also a reason why we see that excitement from the treating community, because using a physical modality against the tumor is intuitive when the tumor has low bioavailability. We see this strength of interest in Optune Pax that you see in the commercial launch numbers.
Frank Leonard: Thank you. Vijay, thank you very much. Thank you, and thank you for the question. You know, when we think about Optune Pax and TTFields for pancreatic cancer, I always want to highlight back to the fact that pancreatic tumors have a low bioavailability for drugs, which is a big reason for why so many drugs have failed in this indication in clinical trials. It's also a reason why we see that excitement from the treating community, because using a physical modality against the tumor is intuitive when the tumor has low bioavailability. We see this strength of interest in Optune Pax that you see in the commercial launch numbers.
Speaker #8: It's also a reason why we see that excitement from the treating community because using a physical modality against the tumor is intuitive when the tumor has low bioavailability.
Speaker #8: And so we see this strength of interest in Optum PACs that you see in the commercial launch numbers but we also do see that in clinical interest in the number of IST proposals we receive in the interest in helping us to design our next wave of trials in pancreatic cancer.
Frank Leonard: We also do see that in clinical interest in the number of IST proposals we receive and the interest in helping us to design our next wave of trials in pancreatic cancer. We think, you know, our device has a unique, a unique biophysical rationale for being used in this tumor type that is definitely recognized by the treating community. In addition, as you know, we are approved for locally advanced pancreatic cancer, which is a unique indication from where the current RAS inhibitor phase 3 data is. We think, you know, we feel very confident that we have and we have a path forward to continue the excitement that we've seen in Q1.
Frank Leonard: We also do see that in clinical interest in the number of IST proposals we receive and the interest in helping us to design our next wave of trials in pancreatic cancer. We think, you know, our device has a unique, a unique biophysical rationale for being used in this tumor type that is definitely recognized by the treating community. In addition, as you know, we are approved for locally advanced pancreatic cancer, which is a unique indication from where the current RAS inhibitor phase 3 data is. We think, you know, we feel very confident that we have and we have a path forward to continue the excitement that we've seen in Q1.
Speaker #8: And so we think our device has a unique biophysical rationale for being used in this tumor type that is definitely recognized by the treating community.
Speaker #8: In addition, as you note, we are approved for locally advanced pancreatic cancer, which is a unique indication from where the current RAS inhibitor phase three data is.
Speaker #8: And we think we feel very confident that we have we have and we have a path forward to continue the excitement that we've seen in the first quarter.
Speaker #8: And I'll ask my colleague, Dr. Uri Weinberg, to comment also on the exciting work that we've been doing to study TTFields with RAS inhibitors.
Frank Leonard: I'll ask my colleague, Dr. Uri Weinberg to comment also on the exciting work that we've been doing to study TTFields with RAS inhibitors.
Frank Leonard: I'll ask my colleague, Dr. Uri Weinberg to comment also on the exciting work that we've been doing to study TTFields with RAS inhibitors.
Speaker #9: Thank you. Hi, Vijay. Nice to hear you. So first, we certainly continue to monitor developments in all of our areas of interest. And we are encouraged to see the new advancements in the field of Caris inhibition.
Uri Weinberg: Thank you. Hi, Vijay. Nice to hear you. First, we certainly continue to monitor developments in all of our areas of interest, and we are encouraged to see the new advancements in the field of KRAS inhibition, first and foremost for the patients, but also with the direct relation to TTFields. TTFields were found to inhibit c-Myc, which is a master regulator of cancer cell proliferation and growth. Therefore, TTFields mediation of downregulation of c-Myc may actually complement the upstream KRAS inhibition, and that would support a potentially more effective therapeutic strategy when the two treatments are used together. In particular, as c-Myc can also be activated through bypass pathways. As Bill mentioned in his opening remarks, this data has been recently presented at AACR.
Uri Weinberg: Thank you. Hi, Vijay. Nice to hear you. First, we certainly continue to monitor developments in all of our areas of interest, and we are encouraged to see the new advancements in the field of KRAS inhibition, first and foremost for the patients, but also with the direct relation to TTFields. TTFields were found to inhibit c-Myc, which is a master regulator of cancer cell proliferation and growth. Therefore, TTFields mediation of downregulation of c-Myc may actually complement the upstream KRAS inhibition, and that would support a potentially more effective therapeutic strategy when the two treatments are used together. In particular, as c-Myc can also be activated through bypass pathways. As Bill mentioned in his opening remarks, this data has been recently presented at AACR.
Speaker #9: First and foremost, for the patients, but also with direct relation to TT fields. TT fields were found to inhibit CMIC, which is master regulator of cancer cell proliferation and growth.
Speaker #9: And therefore, TT fields mediation of downregulation of CMIC may actually complement the upstream Caris inhibition. And that would support a potentially more effective therapeutic strategy when the two treatments are used together.
Speaker #9: And in particular, as CMIC can also be activated through bypass pathways. And as Bill mentioned, it is opening remarks this data has been recently presented at AACR.
Speaker #9: And in a very complementary fashion and independent group of researchers from Mayo Clinic, looked into the concomitant use of TT fields and Caris inhibitors and also repeated these same preclinical effects and reported even a synergy when the two therapies were used concomitantly.
Uri Weinberg: In a very complementary fashion, an independent group of researchers from Mayo Clinic looked into the concomitant use of TTFields and KRAS inhibitors, and also repeated these same preclinical effects and reported even a synergy when the two therapies were used concomitantly. We are very encouraged by that.
Uri Weinberg: In a very complementary fashion, an independent group of researchers from Mayo Clinic looked into the concomitant use of TTFields and KRAS inhibitors, and also repeated these same preclinical effects and reported even a synergy when the two therapies were used concomitantly. We are very encouraged by that.
Speaker #9: So we're very encouraged by that.
Speaker #10: Yeah. And if we if we take a step back, we've always maintained that with tumor treating fields, there's an opportunity to use with whatever the prevailing pharmacological therapy may be.
William Doyle: Yeah. If we, you know, if we take a step back, we've always maintained that with Tumor Treating Fields, there's an opportunity to use with whatever the prevailing pharmacological therapy may be. We've never seen anything less than additivity and in certain circumstances we see the synergy. Now we've seen synergy with checkpoint inhibitors, and we're pursuing that strategy with our KEYNOTE-D58 trial in newly diagnosed GBM. We can see a future here where synergy with RAS inhibitors is also a very interesting treatment strategy for these very difficult to cure cancers.
Bill Doyle: Yeah. If we, you know, if we take a step back, we've always maintained that with Tumor Treating Fields, there's an opportunity to use with whatever the prevailing pharmacological therapy may be. We've never seen anything less than additivity and in certain circumstances we see the synergy. Now we've seen synergy with checkpoint inhibitors, and we're pursuing that strategy with our KEYNOTE-D58 trial in newly diagnosed GBM. We can see a future here where synergy with RAS inhibitors is also a very interesting treatment strategy for these very difficult to cure cancers.
Speaker #10: We've never seen anything less than additivity. And in certain circumstances, we see the synergy. And now we've seen synergy with checkpoint inhibitors and we're pursuing that strategy with our keynote D58 trial in newly diagnosed GBM.
Speaker #10: And we can see a future here where synergy with RAS inhibitors is also a very interesting treatment strategy for these very difficult to cure cancers.
Vijay Kumar: That's helpful. Maybe, one big picture question. Look, when I look at the stock, clearly, you're not getting any benefit or credit for some of the positive data you've had, you know, whether it's lung or pancreatic. I'm curious, maybe the Street wants to see a revenue acceleration rate. When I look at your assumptions here for GBM and pancreatic, could Novocure get back double-digit growth in fiscal 2027? You know, generally talk about big picture, how we should be thinking about the revenue profile for this company going forward.
Vijay Kumar: That's helpful. Maybe, one big picture question. Look, when I look at the stock, clearly, you're not getting any benefit or credit for some of the positive data you've had, you know, whether it's lung or pancreatic. I'm curious, maybe the Street wants to see a revenue acceleration rate. When I look at your assumptions here for GBM and pancreatic, could Novocure get back double-digit growth in fiscal 2027? You know, generally talk about big picture, how we should be thinking about the revenue profile for this company going forward.
Speaker #9: That's helpful. Maybe one big picture question. Look, when I look at the stock, clearly you're not getting any benefit or credit for some of the positive data you've had.
Speaker #9: Whether it's lung or pancreatic, I'm curious. Maybe the street wants to see a revenue acceleration, right? When I look at your assumptions here for GBM and pancreatic, could no cure get back?
Speaker #9: Double-digit growth in fiscal '27. Generally, talk about big picture. How we should be thinking about the revenue profile for this company going forward?
Frank Leonard: Thank you, Vijay. I'll comment first on big picture themes around the GBM business and the panc launch, and I'll turn it to Christoph to talk a little bit more about how we think about the long-term financial forecast. First, you know, we're very pleased to see growth last year in our GBM business, not just international growth in opening new markets, but also in the, you know, core original business in the US growing. You know, as we've said before, we believe there are many more patients that can benefit from the therapy, as we currently have a penetration rate in our active markets of around 40%. What we've continued to do is invest into our GBM business, both the capabilities on the sales and marketing side to, you know, essentially dual cover doctors.
Speaker #8: Thank you, Vijay. I'll comment first on big picture themes around the GBM business and the PANC launch. And I'll turn it to Christoph to talk a little bit more about how we think about the long-term financial forecast.
Frank Leonard: Thank you, Vijay. I'll comment first on big picture themes around the GBM business and the panc launch, and I'll turn it to Christoph to talk a little bit more about how we think about the long-term financial forecast. First, you know, we're very pleased to see growth last year in our GBM business, not just international growth in opening new markets, but also in the, you know, core original business in the US growing. You know, as we've said before, we believe there are many more patients that can benefit from the therapy, as we currently have a penetration rate in our active markets of around 40%. What we've continued to do is invest into our GBM business, both the capabilities on the sales and marketing side to, you know, essentially dual cover doctors.
Speaker #8: So first, we're very pleased to see growth. Last year in our GBM business—not just international growth and opening new markets, but also in the core, original business in the U.S. growing.
Speaker #8: And as we've said before, we believe there are many more patients that can benefit from the therapy. As we currently have a penetration rate in our active markets of around 40%.
Speaker #8: And so what we've continued to do is invest into our GBM business, both the capabilities on the sales and marketing side to essentially dual-cover doctors.
Speaker #8: So if we have call on a community practice for pancreatic cancer, that same rep is now able to reach the community doctors to detail on GBM.
Frank Leonard: If we have a call in a community practice for pancreatic cancer, that same rep is now able to reach the community doctors to detail on GBM. We've also improved our sales operations and targeting capabilities. And we really do feel like we've in our core businesses, and particularly in the US, we have the right team and the right skill sets in place right now to continue driving growth. You know, we think that foundation alone is really an exciting way to think about the next few years. What we've seen in panc right now gives us really an incredible amount of confidence that we can turn this into the second major revenue pillar for the company in the coming years.
Frank Leonard: If we have a call in a community practice for pancreatic cancer, that same rep is now able to reach the community doctors to detail on GBM. We've also improved our sales operations and targeting capabilities. And we really do feel like we've in our core businesses, and particularly in the US, we have the right team and the right skill sets in place right now to continue driving growth. You know, we think that foundation alone is really an exciting way to think about the next few years. What we've seen in panc right now gives us really an incredible amount of confidence that we can turn this into the second major revenue pillar for the company in the coming years.
Speaker #8: We've also improved our sales operations and targeting capabilities. And we really do feel like we've in our core businesses and particularly in the US, we have the right team and the right skill sets in place right now to continue driving growth.
Speaker #8: And so we think that foundation alone is really an exciting way to think about the next few years. And what we've seen in PANC right now gives us really an incredible amount of confidence that we can turn this into the second major revenue pillar for the company in the coming years.
Speaker #10: Yeah. And maybe just to add to this, so to reiterate our strategy is very clearly to get to double-digit revenue growth. And also to profitable growth.
Christoph Brackmann: Yeah. Maybe just to add to this, to reiterate our strategies very clearly, to get to double-digit revenue growth, and also to profitable growth and to profitability. Now, we gave you a revenue guide for this year that is ranging from 5% to 8% at a midpoint, 7% growth, with what I would classify as very initial contributions from new indication launches. With more material contributions from new indication launches, we expect to get into the double-digit revenue growth in the future.
Christoph Brackmann: Yeah. Maybe just to add to this, to reiterate our strategies very clearly, to get to double-digit revenue growth, and also to profitable growth and to profitability. Now, we gave you a revenue guide for this year that is ranging from 5% to 8% at a midpoint, 7% growth, with what I would classify as very initial contributions from new indication launches. With more material contributions from new indication launches, we expect to get into the double-digit revenue growth in the future.
Speaker #10: And to profitability. Now, we gave you a revenue guide for this year. That is ranging from 5% to to 8% at the midpoint, 7% growth.
Speaker #10: With what I would classify as very initial contributions from new indication launches. So with more material contributions from new indication, launches, we expect to get into the double-digit revenue growth in the future.
Vijay Kumar: That's helpful. Thank you.
Vijay Kumar: That's helpful. Thank you.
Speaker #9: That's helpful. Thank you.
Speaker #11: And our next question will be coming from the line of Lawrence Biegelson of Wells Fargo. Lawrence, your line is open.
Operator 2: Our next question will be coming from the line of Larry Biegelsen of Wells Fargo. Lawrence, your line is open.
Operator: Our next question will be coming from the line of Larry Biegelsen of Wells Fargo. Lawrence, your line is open.
Larry Biegelsen: Good morning. Thanks for taking the question. Hey, I wanted to ask, of course, about pancreatic, the pancreatic launch. You know, when we look at newly diagnosed GBM, I mean, we only have Q1 here, but it looks remarkably similar on prescriptions, you know, better on active patients. I know it's early, but what can you say when comparing, you know, prescription launch in the US, you know, an active patient ramp, you know, for newly diagnosed GBM to pancreatic? You know, I'll just ask all my questions up front. Was there any pent-up demand in Q1 for panc? Just OUS timing, remind us of that, please. Thank you.
Lawrence Biegelsen: Good morning. Thanks for taking the question. Hey, I wanted to ask, of course, about pancreatic, the pancreatic launch. You know, when we look at newly diagnosed GBM, I mean, we only have Q1 here, but it looks remarkably similar on prescriptions, you know, better on active patients. I know it's early, but what can you say when comparing, you know, prescription launch in the US, you know, an active patient ramp, you know, for newly diagnosed GBM to pancreatic? You know, I'll just ask all my questions up front. Was there any pent-up demand in Q1 for panc? Just OUS timing, remind us of that, please. Thank you.
Speaker #12: Good morning. Thanks for taking the question. I wanted to ask, of course, about pancreatic. The pancreatic launch. When we look at newly diagnosed GBM, I mean, we only have one quarter here, but it looks remarkably similar on prescriptions.
Speaker #12: Better on active patients. I know it's early, but what can you say when comparing prescription launch in the US and active patient ramp? For newly diagnosed GBM to pancreatic, let me just I'll just ask all my questions up front.
Speaker #12: Was there any pent-up demand in Q1 for PANC? And then just OUS timing remind us of that, please. Thank you.
Frank Leonard: Larry, this is Frank. Thank you for the question. I would say, you know, we haven't really focused on comparing panc to our prior GBM launch, for a technical aspect, which is simply that, in GBM, we had been approved in second-line therapy and had existing relationships. Then in first-line therapy, you know, the data had been out for over a year before the FDA approval. It sort of, on a technical basis, becomes difficult to pick an exact comparison point. What I would anchor back to is the, you know, almost 900 prescribers who sought certification in the first month of commercial, you know, availability.
Frank Leonard: Larry, this is Frank. Thank you for the question. I would say, you know, we haven't really focused on comparing panc to our prior GBM launch, for a technical aspect, which is simply that, in GBM, we had been approved in second-line therapy and had existing relationships. Then in first-line therapy, you know, the data had been out for over a year before the FDA approval. It sort of, on a technical basis, becomes difficult to pick an exact comparison point. What I would anchor back to is the, you know, almost 900 prescribers who sought certification in the first month of commercial, you know, availability.
Speaker #8: Laura, this is Frank. Thank you for the question. I would say we are we haven't really focused on comparing PANC to our prior GBM launch for a technical aspect, which is simply that in GBM, we had been approved in second-line therapy and had existing relationships.
Speaker #8: And then in first-line therapy, the data had been out for over a year before the FDA approval. So it sort of on a technical basis becomes difficult to pick an exact comparison point.
Speaker #8: So what I would anchor back to is the almost 900 prescribers who sought certification in the first month of commercial availability. That was as we said before, that was multiples of the certification levels that we saw in our Lunar launch.
Frank Leonard: That was, you know, as we said before, that was multiples of the certification levels that we saw in our LUNAR launch. We, you know, we do think that reflects some pent-up demand, but I would absolutely not describe it as a bolus of patients waiting and that it then normalized to a different level. We, we do just see really strong interest from the community in using Optune Pax to treat their locally advanced pancreatic cancer patients.
Frank Leonard: That was, you know, as we said before, that was multiples of the certification levels that we saw in our LUNAR launch. We, you know, we do think that reflects some pent-up demand, but I would absolutely not describe it as a bolus of patients waiting and that it then normalized to a different level. We, we do just see really strong interest from the community in using Optune Pax to treat their locally advanced pancreatic cancer patients.
Speaker #8: We did we do think that reflects some pent-up demand, but I don't I would absolutely not describe it as a bolus of patients waiting and that it then normalized to a different level.
Speaker #8: We do just see really strong interest from the community in using Optune packs to treat their locally advanced pancreatic cancer patients. Oh, OUS. I'm sorry.
Larry Biegelsen: OUS?
Lawrence Biegelsen: OUS?
Frank Leonard: Oh, OUS. I'm sorry. Thank you. In terms of OUS, Christoph, can you remind me of the timing?
Frank Leonard: Oh, OUS. I'm sorry. Thank you. In terms of OUS, Christoph, can you remind me of the timing?
Speaker #8: Thank you. In terms of OUS, Christoph, can you remind me of the timing?
Speaker #10: Yeah. So we said second half for both TUV approval as well as for Japan approval.
Christoph Brackmann: Yeah. We said H2 for both German TÜV approval as well as for Japan approval.
Christoph Brackmann: Yeah. We said H2 for both German TÜV approval as well as for Japan approval.
Speaker #9: Yeah. And all the applications are in. We're now just sort of waiting for those submissions. And if everything proceeds as expected, we would launch in the second half in those regions.
William Doyle: Yeah. You know, all the applications are in. We're now, you know, just sort of waiting for those submissions. You know, if everything proceeds as expected, we would launch in H2 in those regions.
Bill Doyle: Yeah. You know, all the applications are in. We're now, you know, just sort of waiting for those submissions. You know, if everything proceeds as expected, we would launch in H2 in those regions.
Speaker #12: I mean, just maybe one follow-up, Frank. I mean, do you think pancreatic could ultimately be bigger than GBM overall? I think you've said that in the past.
Larry Biegelsen: I mean, just maybe one follow-up, Frank. I mean, do you think pancreatic could ultimately be bigger than GBM overall? I think you've said that in the past.
Lawrence Biegelsen: I mean, just maybe one follow-up, Frank. I mean, do you think pancreatic could ultimately be bigger than GBM overall? I think you've said that in the past.
Speaker #8: Well, certainly—so, I think that pancreatic—I think in our current indication, in locally advanced pancreatic cancer, we believe there's around 16,000 patients, which is already bigger than the eligible patient population for Optune Geo.
Frank Leonard: Well, I think in our current indication in locally advanced pancreatic cancer, you know, we believe there's around 16,000 patients, which is already bigger than the eligible patient population for Optune Gio. As we build our evidence base out and, you know, when we're able to secure those additional FDA approvals, it just keeps growing from there. We are absolutely committed to success in this indication. You know, we think it has a tremendous potential to be our second major revenue driver, and ultimately the population is bigger than the population for our current business.
Frank Leonard: Well, I think in our current indication in locally advanced pancreatic cancer, you know, we believe there's around 16,000 patients, which is already bigger than the eligible patient population for Optune Gio. As we build our evidence base out and, you know, when we're able to secure those additional FDA approvals, it just keeps growing from there. We are absolutely committed to success in this indication. You know, we think it has a tremendous potential to be our second major revenue driver, and ultimately the population is bigger than the population for our current business.
Speaker #8: As we build our evidence base out and our when we're able to secure those additional FDA approvals, it just keeps growing from there. So we are absolutely committed to success in this indication.
Speaker #8: And we think it has a tremendous as I said before, to have a tremendous potential to be our second major revenue driver and ultimately the population is bigger than the population for our current business.
Speaker #12: All right. Thank you, guys.
Larry Biegelsen: All right. Thank you, guys.
Lawrence Biegelsen: All right. Thank you, guys.
Speaker #8: Thank you.
Frank Leonard: Thank you.
Frank Leonard: Thank you.
Speaker #11: And our next question. We'll be coming from the line of Emily Bodner of HC Wainwright. Your line is open, Emily.
Operator 2: Our next question will be coming from the line of Emily Bodnar of H.C. Wainwright. Your line is open, Emily.
Operator: Our next question will be coming from the line of Emily Bodnar of H.C. Wainwright. Your line is open, Emily.
Emily Bodnar: Hi. Good morning. Thanks for taking the questions, and congrats on a strong Q1. Curious if you could comment a bit on your confidence for converting the full 169 prescriptions to active patients, and if you can kind of comment on what the average timing has been to converting patients from prescription to active therapy.
Emily Bodnar: Hi. Good morning. Thanks for taking the questions, and congrats on a strong Q1. Curious if you could comment a bit on your confidence for converting the full 169 prescriptions to active patients, and if you can kind of comment on what the average timing has been to converting patients from prescription to active therapy.
Speaker #13: Hi. Good morning. Thanks for taking the questions and congrats on a strong first quarter. Curious if you could comment a bit on your confidence for converting the full 169 prescriptions to active patients and if you can kind of comment on what the average timing has been to converting patients from prescription to active therapy.
Frank Leonard: Yes. Thank you. Yeah, I appreciate the question because, we, you know, it was a big difference between prescriptions and active patients, and that simply reflected the timing of having 1 month at the very end of the quarter. We don't intend to give the number of starts every quarter, but what I will highlight is that we had, you know, we had 90 starts, which led to that active patient number. We saw typically about 2 weeks, a little bit less than 2 weeks from a prescription to a start. You know, that 163 reflects a lot of prescriptions right at the very, very end of the quarter that we'll be talking about on the next earnings calls.
Frank Leonard: Yes. Thank you. Yeah, I appreciate the question because, we, you know, it was a big difference between prescriptions and active patients, and that simply reflected the timing of having 1 month at the very end of the quarter. We don't intend to give the number of starts every quarter, but what I will highlight is that we had, you know, we had 90 starts, which led to that active patient number. We saw typically about 2 weeks, a little bit less than 2 weeks from a prescription to a start. You know, that 163 reflects a lot of prescriptions right at the very, very end of the quarter that we'll be talking about on the next earnings calls.
Speaker #8: Yes. Thank you. Yeah. That's I appreciate the question because it was a big difference between prescriptions and active patients. And that simply reflected the timing of having one month at the very end of the quarter.
Speaker #8: So, we don't intend to give the number of starts every quarter, but what I will highlight is that we had 90 starts, which led to that active patient number.
Speaker #8: And we saw typically about two weeks a little bit less than two weeks from a prescription to a start. And so those that 163 reflects a lot of prescriptions right at the very, very end of the quarter that will be talking about on the next earnings call.
Emily Bodnar: Great. Thanks. Maybe on metastatic pancreatic cancer, obviously you had the PANOVA-4 data, and then you also touched on kind of potential synergy with KRAS inhibitor. Maybe just kind of talk about general strategy moving forward for the metastatic setting.
Emily Bodnar: Great. Thanks. Maybe on metastatic pancreatic cancer, obviously you had the PANOVA-4 data, and then you also touched on kind of potential synergy with KRAS inhibitor. Maybe just kind of talk about general strategy moving forward for the metastatic setting.
Speaker #13: Okay. Thanks. And maybe on metastatic pancreatic cancer, obviously, you had the Panova 4 data and then you also touched on kind of potential synergy with RAS inhibitors.
Speaker #13: So maybe just kind of talk about general strategy moving forward for the metastatic setting.
Uri Weinberg: Thank you for the question. Yeah, we were very pleased to read out the results of the PANOVA 4 study. As a reminder, our single-arm study in metastatic pancreatic cancer patients, using a combination of gemcitabine, Abraxane, atezolizumab, Roche's PD-L1 inhibitor, and the TTFields. The primary endpoint was met. The primary endpoint was disease control rate, and it was significantly increased as a result of using the therapeutic regimen in PANOVA 4 from the historical 48% into 74%. I think that the most important message and takeaways from the PANOVA 4 study is seeing again the relevance of TTFields therapy as a therapeutic approach to be developed in the metastatic setting in pancreatic adenocarcinoma.
Speaker #10: So thank you for the question. Yeah. We were very pleased to read out the results of the Panova 4 study. As a reminder, our single-arm study in metastatic pancreatic cancer patients using a combination of gemcitabine and Abraxane atezolizumab, ROS PD-L1 inhibitor, and TT fields.
Uri Weinberg: Thank you for the question. Yeah, we were very pleased to read out the results of the PANOVA 4 study. As a reminder, our single-arm study in metastatic pancreatic cancer patients, using a combination of gemcitabine, Abraxane, atezolizumab, Roche's PD-L1 inhibitor, and the TTFields. The primary endpoint was met. The primary endpoint was disease control rate, and it was significantly increased as a result of using the therapeutic regimen in PANOVA 4 from the historical 48% into 74%. I think that the most important message and takeaways from the PANOVA 4 study is seeing again the relevance of TTFields therapy as a therapeutic approach to be developed in the metastatic setting in pancreatic adenocarcinoma.
Speaker #10: The primary endpoint was met. The primary endpoint was disease control rate. And it was significantly increased as a result of using the therapeutic regimen in Panova 4 from the historical 48% into 74%.
Speaker #10: I think that's the most important message and takeaways from the Panova 4 study is seeing again the relevance of TT fields therapy as a therapeutic approach to be developed in the metastatic setting in pancreatic adenocarcinoma and following our demonstration of the clinical effectiveness in locally advanced pancreatic cancer in the Panova 3 study and the approval.
Uri Weinberg: Following our demonstration of the clinical effectiveness in locally advanced pancreatic cancer in the PANOVA-3 study and the approval that paves the way to continue the studies and the development in this space. The population used the TTFields therapy at a very desirable usage rate. They use it for the entire protocol-indicated duration of treatment. Again, a great evidence of TTFields' role in metastatic pancreatic cancer, and we continue to explore directions and may come back to this regimen at a later point in time.
Uri Weinberg: Following our demonstration of the clinical effectiveness in locally advanced pancreatic cancer in the PANOVA-3 study and the approval that paves the way to continue the studies and the development in this space. The population used the TTFields therapy at a very desirable usage rate. They use it for the entire protocol-indicated duration of treatment. Again, a great evidence of TTFields' role in metastatic pancreatic cancer, and we continue to explore directions and may come back to this regimen at a later point in time.
Speaker #10: That paves the way to continue the studies and the development in this space. The population used TT fields therapy at a very desirable usage rate.
Speaker #10: They use it for the entire protocol indicated duration of treatment. So again, a great evidence of TT fields' role in metastatic pancreatic cancer. And we continue to explore directions and may come back to this regimen at a later point in time.
Emily Bodnar: Great. Thank you.
Emily Bodnar: Great. Thank you.
Speaker #13: Great. Thank you.
Speaker #11: And our next question will be coming from the line of Jessica Fai of JPMorgan. Jessica, your line is open.
Operator 2: Our next question will be coming from the line of Jessica Fye of J.P. Morgan. Jessica, your line is open.
Operator: Our next question will be coming from the line of Jessica Fye of J.P. Morgan. Jessica, your line is open.
Carly Magee: Hi, guys. Thanks for taking my question. This is Carly Magee for Jess. I wanted to ask for Optune Pax. You mentioned a backlog of stock from the panel. I was wondering if the conversion from prescriptions to patients on therapy is going on as expected. What do you expect the ultimate through to be from these, from those getting prescriptions to those patients who eventually initiate on therapy? Thank you.
Tom Ng: Hi, guys. Thanks for taking my question. This is Carly Magee for Jess. I wanted to ask for Optune Pax. You mentioned a backlog of stock from the panel. I was wondering if the conversion from prescriptions to patients on therapy is going on as expected. What do you expect the ultimate through to be from these, from those getting prescriptions to those patients who eventually initiate on therapy? Thank you.
Speaker #12: Hi, guys. Thanks for taking the question. This is Tan Mayon for Jess. I wanted to ask for Optune packs you mentioned a backlog of stock from the final.
Speaker #12: So I was wondering if the conversion from prescriptions to patients on therapy is going on as expected. And what do you expect the ultimate throughput to be from these from those getting prescriptions to those patients who eventually initiate on therapy?
Speaker #12: Thank you.
Speaker #8: Thank you for the question. We again, we wanted to be clear that with one month of essentially one month and a few days of activity where we could take prescriptions and convert to starts, it's hard to give definitive answers around trends about the rate at which prescriptions will convert to starts.
Frank Leonard: Thank you for the question. You know, again, we wanted to be clear that with essentially one month and a few days of activity where we could take prescriptions and convert to starts, it, you know, it's hard to give definitive answers around trends about the rate at which prescriptions will convert to starts. The consistency I want to emphasize is that we are very pleased with the results so far. We, you know, in particular, I'm really proud of our team who helps the patients, our technical support team that's helping our patients. This is a new patient population for them, and I think the main takeaway in that first month is that we can execute quickly to move from prescription to start.
Frank Leonard: Thank you for the question. You know, again, we wanted to be clear that with essentially one month and a few days of activity where we could take prescriptions and convert to starts, it, you know, it's hard to give definitive answers around trends about the rate at which prescriptions will convert to starts. The consistency I want to emphasize is that we are very pleased with the results so far. We, you know, in particular, I'm really proud of our team who helps the patients, our technical support team that's helping our patients. This is a new patient population for them, and I think the main takeaway in that first month is that we can execute quickly to move from prescription to start.
Speaker #8: But the consistency I want to emphasize is that we are very pleased with the results so far. We in particular, I'm really proud of our team who helps the patients, our technical support team that's helping our patients.
Speaker #8: This is a new patient population for them. And I think the main takeaway in that first month is that we can execute quickly to move from prescription to start.
Frank Leonard: As I mentioned, we had a good strong correlation between active patients at the end and the starts that occurred in the quarter, which means we're giving them the right support to make the treatment feasible and practical.
Speaker #8: And as I mentioned, we had a good strong correlation between active patients at the end and the starts that occurred in the quarter, which means we're giving them the right support to make the treatment feasible and practical.
Frank Leonard: As I mentioned, we had a good strong correlation between active patients at the end and the starts that occurred in the quarter, which means we're giving them the right support to make the treatment feasible and practical.
Carly Magee: Great. Thank you.
Tom Ng: Great. Thank you.
Speaker #12: Great. Thank you.
Operator 2: I'm showing no further questions at this time. I would like to turn the conference back to William Doyle for closing remarks.
Speaker #11: And I'm showing no further questions at this time. I would like to turn the conference back to Bill Doyle for closing remarks.
Operator: I'm showing no further questions at this time. I would like to turn the conference back to William Doyle for closing remarks.
Speaker #8: Thank you. I’d like to end the call today by noting that Novocure was able to maintain the momentum of the fourth quarter last year, with strong and consistent execution in Q1.
William Doyle: Thank you. I'd like to end the call today by noting that Novocure was able to maintain the momentum of Q4 last year with strong and consistent execution in Q1. We're very pleased to see double-digit growth in both active patients and net revenue compared to Q1 last year. Very promising early signals both from our LUNAR launch in Japan and of course from our Optune Pax launch in the US. Our 2026 catalysts remain on track. We look forward to continued reporting on the developments in the commercial business as well as the top-line data from TRIDENT up next in next quarter.
Bill Doyle: Thank you. I'd like to end the call today by noting that Novocure was able to maintain the momentum of Q4 last year with strong and consistent execution in Q1. We're very pleased to see double-digit growth in both active patients and net revenue compared to Q1 last year. Very promising early signals both from our LUNAR launch in Japan and of course from our Optune Pax launch in the US. Our 2026 catalysts remain on track. We look forward to continued reporting on the developments in the commercial business as well as the top-line data from TRIDENT up next in next quarter.
Speaker #8: We're very pleased to see growth in both double-digit growth in both active patients and net revenue compared to Q1 last year. And very promising early signals of both from our Lunar Launch in Japan and, of course, from our Optune packs launch in the US.
Speaker #8: Our 2026 catalysts remain on track. We look forward to continued reporting on the developments in the commercial business as well as the top-line data from Trident up next in next quarter.
William Doyle: We didn't talk about it much in this call, but our company remains focused not only on achieving the double-digit growth that Christoph underlined, but also on bringing the company to profitability. We were also very pleased with our numbers in that regard, and we are focused as we have updated in our guidance on our path to profitability. So thanks to the team at Novocure, thanks to our patients and clinicians. It's an exciting time to be at the company, and we look forward to reporting our progress in the next quarters.
Speaker #8: We didn't talk about it much in this call, but our company remains focused not only on achieving the double-digit growth that Christoph underlined, but also on bringing the company to profitability.
Bill Doyle: We didn't talk about it much in this call, but our company remains focused not only on achieving the double-digit growth that Christoph underlined, but also on bringing the company to profitability. We were also very pleased with our numbers in that regard, and we are focused as we have updated in our guidance on our path to profitability. So thanks to the team at Novocure, thanks to our patients and clinicians. It's an exciting time to be at the company, and we look forward to reporting our progress in the next quarters.
Speaker #8: And we were also very pleased with our numbers in that regard and we are focused as we have updated in our guidance on our path to profitability.
Speaker #8: So thanks to the team. Novacure, thanks to our patients and clinicians. And it's an exciting time to be at the company. And we look forward to reporting our progress in the next quarters.
Operator 2: This concludes today's program. Thank you for participating. You may now disconnect.
Operator: This concludes today's program. Thank you for participating. You may now disconnect.