Q4 2023 Novocure Ltd Earnings Call

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Operator: Good day, and thank you for standing by. Welcome to the Novocure Q4 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode.

Good day and thank you for standing by welcome to the Novocure Q4, 2023 earnings conference call.

At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone you will then hear an automated message advising your hand, just raised to withdraw your question. Please.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised.

Operator: To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Ingrid Goldberg.

Press Star one one again please.

Please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today Ingrid Goldberg. Please go ahead.

Ingrid Goldberg: Good morning, and thank you for joining us to review Novocure's fourth quarter 2023 performance. I'm joined this morning by our Executive Chairman, Bill Doyle, our CEO, Asaf Danziger, and our CFO, Ashley Cordova. Other members of the Executive Leadership Team will be available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.novacure.com, on our Investor Relations page, under Quarterly Reports. Before we start, I would like to remind you that our discussions during this conference call will include forward-looking statements, and actual results could differ materially from those projected in these statements. These statements involve a number of risks and uncertainties, some of which are beyond our control and are described from time to time in our SEC filings. We do not intend to update publicly any forward-looking statement except as required by law. Where appropriate, we refer to non-GAAP financial measures to evaluate our business, specifically adjusted EBITDA, a measure of earnings for interest, taxes, depreciation, amortization, and share-based compensation.

Yeah.

Ingrid Goldberg: Good morning, and thank you for joining us to review <unk> fourth quarter 2023 performance.

Ingrid Goldberg: I'm joined this morning by our executive Chairman Bill Doyle, our CEO soft Donziger CFO Ashley Cordova.

Ingrid Goldberg: Other members of the executive at the district team will be available for Q&A.

Ingrid Goldberg: For your reference slides accompanying this earnings release can be found on our website www dot dot com on our Investor Relations page under quarterly reports.

Ingrid Goldberg: Before we start I would like to remind you that our discussions during this conference call will include forward looking statements and actual results could differ materially from those projected in these statements.

Ingrid Goldberg: These statements involve a number of risks and uncertainties some of which are beyond our control and are described from time to time in our SEC filings, we do not intend to update publicly any forward looking statements except as required by law.

Ingrid Goldberg: 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.

Ingrid Goldberg: We believe, as Justin David does, this is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material non-cash items and best reflects the financial value generated by our business. Reconciliations of non-gap-to-gap financial measures are included in our press release, earnings slides, and in our Form 8K filed with the SEC today. These materials can also be accessed from the Investor Relations page of our website.

Ingrid Goldberg: We believe adjusted EBITDA is an important metric as it removes the impact of earnings attributable to our capital structure tax rate and a material noncash item and best reflects the financial value generated by our business.

Ingrid Goldberg: Reconciliations of non-GAAP to GAAP financial measures are included in our press release earnings slides and in our form 8-K filed with the SEC today.

Ingrid Goldberg: These materials can also be accessed in the Investor relations page of our website.

William F. Doyle: Following our prepared remarks today, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle. Thank you. At Novocure, our mission is to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our novel therapy, tumor targeting. In 2023, we made notable strides and reached many important milestones in our commercial, clinical research, and product development programs. Our commercial business treating patients with GBM finished the year with 9% year-over-year growth in active patients on therapy. Our lunar phase 3 trial in non-small cell lung cancer met its primary end goal.

Ingrid Goldberg: Following our prepared remarks today, we will open the line for your questions I will now turn the call over to our executive Chairman Bill Doyle.

William F. Doyle: Thank you Ingrid.

William F. Doyle: Novocure our mission is to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our novel therapy tumor treating fields. In 2023, we made notable strides and reached many important milestones in our commercial clinical research and.

Product development programs.

William F. Doyle: Our commercial business treating patients with GBM finished the year with 9% year over year growth in active patients on therapy.

William F. Doyle: Our lunar phase III trial in non small cell lung cancer met its primary endpoint.

William F. Doyle: We completed enrollment in two additional phase three trials, MEDIS and PANOVA 3, and we completed enrollment in the TRIU trial in January. We launched Lunar 2 and Panova 4, which are now initiating sites for enrolling patients, and the protocols of two new clinical trials, Keynote, V58, and Lunar 4, are under regulatory review.

William F. Doyle: We completed enrollment of two additional phase III trials.

William F. Doyle: <unk> three and we completed enrollment of the Triton trial in January.

William F. Doyle: We launched lunar two and panel before which we're now initiating sites and enrolling patients.

William F. Doyle: And the protocols up two new clinical trials.

William F. Doyle: Note the 58 and lunar four are under regulatory review.

William F. Doyle: We successfully introduced our Next Generation Arrays in several European countries and filed the PMA supplement for approval to bring the new arrays to patients in the U.S. Importantly, we have now treated over 30,000 patients since we first started commercial operations, and we ended the year with a record number of active patients on therapy. I am incredibly proud of our colleagues and look forward to a data and catalyst-driven 2024. 2024 is an important year for Novocure with more milestones on the horizon. We are laser focused on achieving three core objectives, growing our GPM business. Launching Kiki Fields in non-small cell lung cancer camp and Delivering our Clinical and Product Development Pipeline

William F. Doyle: We successfully introduced our next generation of race in several European countries and filed the PMA supplement for approval to bring the newer rates the patients in the U S.

William F. Doyle: Importantly, we have now treated over 30000 patients since we first started commercial operations.

William F. Doyle: We ended the year with a record number of active patients on therapy.

William F. Doyle: I am incredibly proud of our colleagues achievements and look forward to a data and catalyst driven 2024.

William F. Doyle: 2024 is an important year for novocure with more milestones on the horizon.

William F. Doyle: We are laser focused on achieving three core objectives.

Growing our GBM business.

William F. Doyle: Launching TT fields in non small cell lung cancer, and delivering our clinical and product development pipelines.

William F. Doyle: Achieving these objectives will position our company for success for years to come. I'll begin this morning with a review of our commercial GBN and Non-Small Cell Lung Cancer Program. FOSS will then discuss clinical trial and product development, followed by Ashley's review of our finances. Our commercial GBM business is key to our long-term success. Thriving growth in our core country markets is a central objective in 2024.

William F. Doyle: Achieving these objectives will position our company for success for years to come.

William F. Doyle: I'll begin this morning, with a review of our commercial GBM business and non small cell lung cancer program.

Jeff will then provide clinical trial and product development updates followed by Ashley's review of our financial performance.

William F. Doyle: Our commercial GBM business is key to our long term success.

William F. Doyle: Driving growth in our core country markets as a central objective in 2024.

William F. Doyle: We ended 2023 with a record 3,755 active patients on tumor treating field therapy and generated $509 million in net revenue for the year. To achieve our growth goals, we are focused on building greater awareness and engagement with patients and prescribers, and enhancing the quality of We are focused on seamless cross-functional alignment and a synchronized approach to driving the key levers, such as prescriptions, patient starts, compliance, and therapy duration. Each of these inputs is critical for the best outcomes for patients and for achieving sustainable growth. We have always been a data-driven organization. As health care providers move to further integrate tiki pills therapy into their practice,

William F. Doyle: We ended 2023 with a record 3755 active patients on tumor treating fields therapy and generated $509 million and net revenue for the year.

William F. Doyle: To achieve our growth goals, we are focused on building greater awareness and engagement with patients and prescribers and enhancing the quality of deep engagements.

William F. Doyle: We are focused on seamless cross functional alignment and synchronized approach to driving the key levers of growth.

William F. Doyle: Ascription patient starts compliance and therapy duration.

William F. Doyle: Each of these inputs is critical for the best outcomes for patients and to achieving sustainable growth.

William F. Doyle: We have always been a data driven organization.

William F. Doyle: Care providers move to further integrate <unk> therapy into their practices we.

William F. Doyle: We are determined to provide the clinical data to best inform TT fields therapy, and a critical part of that is the generation of real-world evidence. Last month at J.P. Morgan, we shared a preliminary analysis of a real-world study that included all 974 newly diagnosed GBM patients who began Optune Geo treatment in the U.S. in the second half of 2019. The 4-Year Survival rate for patients was 24%, compared to 8%

William F. Doyle: We are determined to provide the clinical data to best inform TT fields therapy use.

A critical part of this effort is the generation of real world evidence.

William F. Doyle: Month of J P. Morgan, we shared a preliminary analysis of a real World study, which included all 974 newly diagnosed GBM patients who began opportune geo treatment in the U S. In the second half of 2019.

William F. Doyle: The four year survival rate of these patients was 24% compared to 8% for patients treated with chemotherapy alone historically.

William F. Doyle: It is worth noting that the real-world data fully support the results from the landmark EF14 Phase 3 clinical trial, which demonstrated 20% four-year survival for patients treated with TT fields and temozolomide. These new real-world data will be added, peer-reviewed, and published later this year. But the bottom line is, large, real-world data sets confirm that tumor-treating fields therapy can provide significant survival benefits for patients struggling with this devastating disease. As we continue to generate more real-world data, we will be working to increase physician awareness of outcomes and, importantly, build patient awareness. As our therapy is a unique modality, we know that physicians or patients can drive the choice of TP fields as a therapy option. To this end, we have adjusted our organization to integrate patient support and physician support earlier in the patient journey. Direct engagement with physicians will enable our teams to provide more hands-on assistance at the time a prescription is considered and written.

William F. Doyle: It is worth noting that the real world data fully support the results from the landmark Eef <unk> phase III clinical trial, which demonstrated 20% four year survival for patients treated with TT field <unk>.

William F. Doyle: These new real World data will be added to peer reviewed and published later this year, but the Bottomline is large real world data sets confirm that tumor treating fields therapy can provide a significant survival benefit for patients struggling with this devastating disease.

William F. Doyle: As we continue to generate more real world data, we will be working to increase physician awareness of outcomes and importantly build patient awareness of the data.

William F. Doyle: Our therapy has a unique modality, we know that physicians or patients can drive the choice of TT fields as a therapy option.

William F. Doyle: To this end, we've adjusted our organization to integrate patient support and physician support earlier in the patient journey.

William F. Doyle: Direct engagement with physicians will enable our teams to provide more hands on assistance at the time of prescription is considered and red.

William F. Doyle: We believe early engagement with patients will drive higher conversion of scripts to patient starts and deliver a more seamless therapy experience. Our second key objective in 2024 is the regulatory approval and successful launch of tumor treating fields in non-small cell lung cancer. As a reminder, last year we published the results of the Phase III Lunar Trial. Lunar showed a statistically significant and clinically meaningful survival demo for second-line non-small cell lung cancer patients who progressed on platinum-based chemotherapy and who used TT fields and standard therapies compared to patients who only used standard therapy. Since announcing positive top-line lunar data, we have made steady progress towards our goal of commercial launch in 2024. In December, we filed the necessary regulatory submissions in our three major markets, the U.S., Europe, and China.

William F. Doyle: We believe early engagement with patients will drive higher conversion of scripts to patient starts and deliver a more seamless therapy experience.

William F. Doyle: Our second key objective in 2024 is the regulatory approval and successful launch of tumor treating fields in non small cell lung cancer.

William F. Doyle: As a reminder, last year, we published the results of the phase III lunar trial lunar.

Lunar showed a statistically significant and clinically meaningful survival benefit for <unk>.

William F. Doyle: Second line non small cell lung cancer patients, who progressed on platinum based chemotherapy and who use TT fields and standard therapies compared to patients who only use standard therapies.

William F. Doyle: Since announcing positive top line <unk> data, we have made steady progress towards our goal of commercial launch in 2024.

William F. Doyle: In December we filed the necessary regulatory submissions in our three major markets the U S Europe and Japan.

William F. Doyle: In January, the FDA formally accepted our PMA submission for final, and the PMA is now under substantive review. At the 100-day mark, which will occur in mid-March, we anticipate meeting with the FDA to discuss their next steps. Our team is fully prepared to address any questions, and we look forward to engaging with the FDA in the coming months. Outside the U.S., we are awaiting a CE Mark decision in Europe and regulatory next steps in Japan. Pending regulatory approvals, our goal is to launch in Germany in the first half of 2024 and in the U.S. in the second half of 2024.

William F. Doyle: In January the SBA formally accepted our PMA submission for <unk>.

William F. Doyle: And the PMA is now under substantive review.

William F. Doyle: At the 100 day, Mark which will occur in mid March we anticipate meeting with the FDA to discuss their next steps.

Our team is fully prepared to address any questions and we look forward to engaging with the FDA in the coming months.

William F. Doyle: Outside the U S. We are awaiting a CE mark decision in Europe, and regulatory next steps in Japan.

Pending regulatory approvals our goal is to launch in Germany in the first half of 2024, and then the U S. In the second half.

William F. Doyle: Once we receive marketing approvals, we will engage payers in Germany and the U.S. to establish reimbursements. We plan to start patients on therapy in Germany and the U.S. immediately following approval using a named patient reimbursement process, similar to that we used when we launched GBM. We are eager to open this new chapter at Novocure and look forward to potentially treating many more patients in the coming months. In 2024, our teams will also deliver top-line results from the MEDIS and PANOVA 3 trials. Clinical Tribes, Both trials are fully enrolled and now in patient follow-up. Asaf will discuss these trials momentarily. But timing indicates Novocure could announce material data or new indication approvals in every quarter of 2024. It's going to be a very exciting day.

William F. Doyle: Once we receive marketing approvals, we will engage payers in Germany, and the U S to establish reimbursement.

William F. Doyle: We plan to start patients on therapy in Germany, and the U S. Immediately following approval using a named patient reimbursement process similar to that we use when we launched GBM.

William F. Doyle: We are eager to open this new chapter at Novocure and look forward to potentially treating many more patients in the coming months.

William F. Doyle: In 2024, our teams will also deliver top line results of the ladder and canova three clinics.

William F. Doyle: Clinical trials.

William F. Doyle: Both trials are fully enrolled and now in patient follow up.

William F. Doyle: Thoughtful discuss these trials momentarily.

William F. Doyle: But timing indicates novocure could announce material data or new indication approval every quarter of 2024.

William F. Doyle: It's going to be a very exciting year.

William F. Doyle: Before I pass the call to Asaf to discuss our clinical program, I would like to publicly welcome our new Chief Medical Officer, Dr. Nicholas LaPrince, who joined Novocure in January. Dr. Lapin brings a wealth of valuable experience to Novocure as a former practicing oncologist and as a leader of clinical operations at some of the most innovative biotech companies. Nicholas has a proven track record of achievement, and he is making great contributions

Speaker Change: Before I pass the call to across to discuss our clinical programs I would like to publicly welcome our new Chief Medical Officer, Dr. Nicholas <unk>.

Dr. Nicholas: Who joined <unk> in January Dr. <unk> brings a wealth of valuable experience to know Victor as a former practicing oncologists and as the leader of clinical operations at some of the most innovative biotechnology companies.

Dr. Nicholas: Nicolas has a proven track record of achievement and he is making great contributions already.

Asaf Danziger: Nicholas and Michael Puri, our new Chief Human Resources Officer who joined in Q3 2023, are important additions to our executive team. Welcome, Michael, and welcome Nick. I'll now turn the call over to Asaf to discuss our clinical objectives. Thank you. As Bill mentioned, we are focused on three objectives in 2024: to grow our GBM business, launch Lung Cancer, and deliver on our pipeline. We have consolidated our clinical trial initiatives into three indications where we have proven efficacy and can address significant unmet needs. These are GBM, non-small cell lung cancer, and pancreatic cancer. Option Geo, together with Imozolomide, is an NCCN Category 1 Preferred Therapy Regimen for newly diagnosed GBM and considered standard of care.

Dr. Nicholas: Nicholas and Michael <unk>, our new Chief Human Resources Officer, who joined in Q3 2023 are important additions to our executive team welcomed.

Dr. Nicholas: Welcome Michael and welcome Nicolas.

Speaker Change: Now turn the call over to <unk> to discuss our clinical objectives.

Speaker Change: Thank you.

Speaker Change: As Bill mentioned, we are focused on three objectives in 2024 grow our GBM business loans lung cancer and delivering our pipeline.

Speaker Change: We have consolidated our clinical trial initiatives into three indications, where we have proven efficacy and can address significant unmet needs. These GBM non small cell lung cancer and pancreatic cancer.

Speaker Change: <unk> together with the Mozilla mind is in NSE cm category, one preferred therapy regimen in newly diagnosed GBM and considered the standard of care.

Asaf Danziger: But we believe we can extend survival even further. We have two phase three trials focused on this goal. The first is Trident, which completed enrollment last month. Trident is studying the survival benefit of starting Optium Geo with chimera radiation rather than after chimera radiation, two to three months earlier than today's standard protocol. Clinical studies and preclinical research have shown that the mechanisms of action of radiation entity fields can work together to create a more pronounced cytotoxic environment for cancer cells and can potentially extend patient survival.

But we believe we can extend survival even further.

Speaker Change: We have two phase III trials focused on this goal.

Speaker Change: The first is Trident, which completed enrollment last month's Trident is touting the survival benefit of starting <unk> with chemo radiation rather than after chemo radiation to the three months earlier than today's standard protocol cleaning.

Speaker Change: Clinical studies and preclinical research has shown that the mechanisms of action of radiation MTT fields can work together to create a more pronounced cytotoxic environment for cancer cells and can potentially extend patient survival.

Asaf Danziger: Trident has a 24-month follow-up from last patient in, and top-run results will be available in 2026. In addition to Trident, we have submitted the IMD to the FDA and are preparing to launch the phase 3 keynote D50A trial. Kino D58 will study opti-angio, temozolomide, and immunotherapy pembrolizumab for the treatment of newly diagnosed TB.

Speaker Change: Try them has a 24 month follow up from last patient team subprime results will be available in 2026.

Speaker Change: In addition to try it and we have submitted to the FDA and are preparing to loans the phase III keynote <unk> trial.

Speaker Change: The 58 will study <unk>, Gilles tomasulo mined and immunotherapy <unk> for the treatment of newly diagnosed GBM.

Asaf Danziger: Kino D58 was initiated to confirm preclinical research and the exciting clinical data from Dr. David Tranz for the TOP Phase II trial. At the Snow Annual Meeting in November, Dr. Tranz presented updated data from the TOP study. The median overall survival of patients in the trial was 24.8 months, compared to 14.6 months for a match control cohort from our year 14 data. The to-the-top phase two results are very promising, and we are eager to launch Kino D58 and begin enrolling patients this year. Trident, Keynote D58, and technological improvements, like our new arrays, provide possibilities to further improve survival for GBM patients and demonstrate our continued commitment to the neuro-oncology field.

Speaker Change: The 58 was initiated to confirm preclinical research and the exciting clinical data from ductile, David trends to the phase II trial.

Speaker Change: There's no annual meeting in November Dr. <unk> presented updated data from to the top.

Speaker Change: The median overall survival of patients in the trial with 24 eight months compared to $14 six months for our matched control cohort from our EF 14 data set.

Speaker Change: The two the two phase II results are very promising and we are eager to loans cannot be 58 and begin enrolling patients this year.

Speaker Change: Trident Chemo D 58, and technological improvements.

Speaker Change: Your raise provide possibilities to further improve survival for GBM patients and demonstrate our continued commitment to the network quality field.

Asaf Danziger: We look forward to sharing more information on these programs in the future. We are also focused on the treatment of non-small cell lung cancer. The success of the LUNAR trial provides the foundation for a number of additional lung cancer trials. Last year, the IDE was approved for LUNAR2, and we began site initiation.

Speaker Change: We look forward to sharing more information on these programs in the future.

Speaker Change: We are also focused on the treatment of non small cell lung cancer.

Speaker Change: Success of the lunar trial provides the foundation for a number of additional lung cancer trials last year. The idea was approved for lunar two and we began site initiations now.

Asaf Danziger: Lunar 2 will evaluate the use of TT fields together with the immunotherapy pembrolizumab and platinum-based chemotherapy in first-line metastatic non-small-cell lung cancer. The protocol for the Phase 2 Lunar 4 trial is under review by regulatory authorities, and we hope to launch it later this year. Lunar 4 will study the use of TT fields and immunotherapy in the second line, following first-line immunotherapy. We also continue to enroll patients in the Phase 2 Keynote B36 trial, evaluating TT-field therapy and pembrolizumab in first-line treatment of locally advanced or metastatic non-small-cell lung cancer. Given the success of LUNAR, we believe we are just scratching the surface of the potential of TT fields in non-small cell lung cancer. We are also exploring the use of TT fields for the treatment of secondary tumors. Our Phase III METIS trial is studying TT fields following stereotactic radiosurgery for brain metastasis in non-small cell lung cancer.

Speaker Change: Two we will evaluate the use of <unk> together with the immunotherapy <unk> amount and platinum based chemotherapy in first line metastatic non small cell lung cancer.

Speaker Change: The protocol for the Phase two Luna phone trial is under review by regulatory authorities and we hope to launch later this year.

Speaker Change: Lenovo will study use of TT fields and immunotherapy in the second line. Following first line immunotherapy. We are also continuing to enroll patients in the phase II cannot be 36 trial evaluating TT fields therapy and <unk> in first line treatment of locally advanced.

Speaker Change: All metastatic non small cell lung cancer.

Speaker Change: Given the success of flu now we believe we are just scratching the surface of the potential of <unk> in non small cell lung cancer.

Speaker Change: We are also exploring the use of <unk> for treatment of secondary tumors are.

Speaker Change: Our phase III Metis trial is targeting TT field following stereotactic radiosurgery for brain metastases from non small cell lung cancer.

Asaf Danziger: We will finish enrolling METIs in March 2023 and will complete the minimum 12-month follow-up from last patient in the coming weeks. Once follow-up is complete, we expect to announce top-line results at the end of Q1. MEDIS addresses a significant unmet need in a large heterogeneous patient population. We are eager to understand if T-Diffuse can provide benefit to these patients.

We finished enrolling metis in March 2023, and will complete the minimum 12 months follow up from last patient in in the coming weeks.

Speaker Change: One follow up is complete we expect to announce top line results at the end of Q1.

Speaker Change: <unk> addresses a significant unmet need in a large it's a genius patient population.

Speaker Change: We are eager to understand if the diffuse can provide benefit to these patients.

Asaf Danziger: In aggregate, our non-small cell lung cancer program will include five trials, Lunar, Lunar 2, Lunar 4, Keynote B36, and MEDIC. These trials allow us to study the use of tt fills across multiple stages of non-small cell lung cancer and have the potential to unlock the availability of tt fills therapy for tens of thousands of patients. The third clinical program we are focused on in 2024 is pancreatic cancer. We have two ongoing clinical trials in pancreatic cancer, PANOVA3 and PANOVA4. The phase 3 PANOVA3 trial is evaluating the use of TT fields together with Neb Paklitaxel and James Eiderbein for the treatment of first-line locally advanced pancreatic cancer.

Speaker Change: In aggregate, our non small cell lung cancer program will include five trials lunar lunar to Luna for cannot be 36, and <unk>. These trials and allow us to study the use of <unk> across multiple stages of non small cell lung cancer and have the potential to unlock everything.

Speaker Change: The ability of TT fields therapy for tens of thousands of patients.

Speaker Change: The third leg of program. We are focused on in 2024 is pancreatic cancer. We have two ongoing clinical trials in pancreatic cancer panel <unk> III and Panama for the Phase III partner three trial is evaluating the use of TT fields, together with Nab Paclitaxel and James side of it.

Speaker Change: For the treatment of first line locally advanced pancreatic cancer.

Asaf Danziger: We completed enrollment in Panova 3 last year and expect to announce top-line results in Q4 2025. We also launched the Phase 2 PANOVA4 trial last year. PANOVA4 is evaluating the addition of the immunotherapy atizolizumab to the regimen used in PANOVA3 to treat first-line metastatic pancreatic cancer.

Speaker Change: We completed enrollment of panel suite last year and expect to announce topline results in Q4 2024.

Speaker Change: Also launched the phase II part of a full trial last year part of our fall is evaluating. The addition of the immunotherapy is the Liza map to the regimen used in Panama three to treat first line metastatic pancreatic cancer.

Asaf Danziger: Unfortunately, pancreatic cancer is an indication that is growing and for which there is a great unmet need. We look forward to reviewing the data from these trials as soon as possible. As previously mentioned, we are also exploring opportunities to improve our therapy through product development. In 2023, we will launch our next generation arrays in Europe for GBM. Feedback has been positive, and patients have mentioned increased comfort and ease of use.

Speaker Change: Unfortunately, pancreatic cancer is an indication that is growing and for which there is a great unmet need.

Speaker Change: We look forward to reviewing the data from these trials as soon as possible.

Speaker Change: As previously mentioned, we are also exploring opportunities to improve our therapy through product development.

Speaker Change: In 2023, we launched our next generation arrays in Europe for GBM.

Speaker Change: Feedback has been positive patients have mentioned increased comfort and ease of use in.

Asaf Danziger: In December, we filed a PMA supplement for approval to market the new arrays in the U.S. If approved, we look forward to launching them in U.S. patients in the second half of 2025. I am extremely encouraged by our achievements in 2023 and excited for the catalysts on the horizon this year. Our team is focused on our key objectives and energized to reach more patients in need. I look forward to updating you all on our progress throughout the year. Ashley will now run through our fourth quarter and full year performance. Thank you, Asaf.

Speaker Change: In December we filed a PMA supplement for approval to market the new arrays in the U S. If approved we look forward to launching in the U S patients in the second half of 2024.

I am extremely encouraged by our achievements in 2023 and excited for the catalysts on the horizon This year.

Speaker Change: Our team is focused on our key objectives and energized to reach more patients in need.

Speaker Change: Look forward to updating you all on our progress throughout the year.

Speaker Change: Actually will now run through our fourth quarter and full year performance.

Speaker Change: Thank you.

Ashley Cordova: The fourth quarter was another quarter of progress and execution at Novocure, setting the stage for a strong 2024. We generated $134 million in net revenue in the quarter and $509 million for the year.

Speaker Change: The fourth quarter was another quarter of progress and execution at nearby care setting the stage for a strong 2024.

Speaker Change: We generated $134 million of net revenue in the quarter and $509 million for the year.

Ashley Cordova: We ended the year with a record 3,755 active patients on therapy, an increase of 9% from year-end 2022. One of our key objectives this year is to drive growth in our GVM. As we transition into 24, several of the complex situations that have affected our business in recent years have been largely resolved. This includes depletion of the most accessible flow of back-launched Medicare.

Speaker Change: We ended the year with a record 3755 active patients on therapy and increase of 9% from year end 2022.

Speaker Change: One of our key objectives. This year is to drive growth in our GBM business.

Speaker Change: As we transition into 'twenty for several of the complex situations that have affected our business in recent years have been largely resolved.

Speaker Change: This includes the depletion of the most accessible flow of backhaul to Medicare payments.

Ashley Cordova: Achievement of a revenue baseline in our newly launched French market and successful negotiations with German payers. The resolution of these variables serves to strengthen the foundation for net revenue growth, directly tied to active patients on therapy, duration of therapy, and price. Novocure's team in every function is aligned to support and enhance these drivers in 2024 and beyond. One of our victories in the fourth quarter was the continued success of our Optune Geo launch in France.

Speaker Change: Achievement of a revenue baseline and our newly launched French market.

Speaker Change: Successful negotiations with German Payor.

Speaker Change: The resolution of these variable tariff to strengthen the foundation for net revenue growth. This year directly tied to active patients on therapy duration of therapy and correct.

Speaker Change: Nobody cares team in every function is aligned to support and enhance these drivers in 2024 and beyond.

Speaker Change: One of our victories in the fourth quarter was the continued success of our <unk> launch in France.

Ashley Cordova: Our business in France was a tailwind to our EMEA active patient count throughout the year and contributed $8 million in the fourth quarter. This sets a strong baseline as we move into 2024. In the fourth quarter, we also saw strength in Germany, with year-over-year increases of 21% in prescriptions and 12% in activations on their side.

Speaker Change: Our business in France was a tailwind to our EMEA after patient count throughout the year and contributed $8 million in the fourth quarter.

Speaker Change: This sets a strong baseline as we move into 2024.

Speaker Change: In the fourth quarter, we also saw strength in Germany with year over year increases of 21% in prescription and 12% in active patients on therapy.

Ashley Cordova: As a reminder, in mid-2022, we engaged with German payers to negotiate updated contract terms that effectively paused our German business. As expected, it took approximately six quarters to recover. Moving forward, we expect the fourth quarter to serve as the day sign for our German business. Gross margin for the fourth quarter was 76%. For color, growth margin was affected by two near-term facts, investment in increased patient support capacity and the rollout of our next generation array. In time, we expect these factors to be offset by increased active patient counts and improved efficiencies with scale as we optimize manufacturing of our new array. Last year, we implemented portfolio prioritization and strategic restructuring initiatives to realign our business to support near-term growth and long-term value creation. As a result of these initiatives, we streamlined our operations, removing $60 million in residual.

Speaker Change: As a reminder, in mid 2020 to be engaged with German payers to negotiate updated contract terms that effectively caused our chairman.

Speaker Change: As expected it took approximately six quarters to recover.

Speaker Change: Moving forward, we expect the fourth quarter, two third as the baseline for our German market.

Speaker Change: Gross margin for the fourth quarter was 76% for <unk>.

Speaker Change: Color gross margin was affected by two near term factors.

Speaker Change: Investment and increased patient support capacity and the rollout of our next generation array.

Speaker Change: In time, we expect these factors to be offset by increased active patient count and improved efficiencies with scale as we optimize manufacturing of our new array.

Last year, we implemented portfolio prioritization and strategic restructuring initiatives to realign our business to support near term growth and long term value creation.

Speaker Change: As a result of these initiatives, we streamlined our operating expenses, removing $60 million and residual opex.

Ashley Cordova: This streamlining will enable us to invest in future growth initiatives like our non-small cell lung cancer launch without increasing our cash burn. We believe in the immense potential of the tumor treating field platform and are investing accordingly. But we also recognize the need to accelerate our path to profitability. We are confident that recent adjustments will position Novocure to create shareholder value while achieving our mission of extending survival in some of the most aggressive forms. SG&A expenses for the fourth quarter were $99 million.

Speaker Change: This streamlining will enable us to invest in future growth initiatives like our non small cell lung cancer launch without increasing our cash burn.

Speaker Change: We believe in the potential of the tumor treating fields platform and are investing accordingly.

Speaker Change: We also recognize the need to accelerate our path to profitability.

Speaker Change: We are confident that risk adjustments will position novacare to create shareholder value, while achieving our mission of extending survival in some of the most aggressive forms of cancer.

SG&A expenses for the fourth quarter were $99 million.

Ashley Cordova: Looking ahead, SG&A expenditures will be distributed to support areas with the highest growth potential and in alignment with our 2024 goals. This includes global commercial infrastructure and launch preparation ahead of our anticipated non-small cell lung cancer launch. Research, development, and clinical trial costs in the quarter were $54 million.

Speaker Change: Looking ahead SG&A expenditures will be distributed to support areas with the highest growth potential and in alignment with our 2024 our goal.

Speaker Change: This includes global commercial infrastructure and launch preparation ahead of our anticipated non small cell lung cancer launch.

Speaker Change: Research development and clinical trial costs in the quarter were $54 million.

Ashley Cordova: Our R&D spending is largely tied to the number of ongoing clinical trials at a given moment. As the current slate of Phase 3 trials nears completion, we are in the process of launching our next set of trials, including Lunar 2 and Keynote D58. Following our portfolio prioritization efforts last year, future R&D investments will be focused on areas of highest return, GBM, non-sulfoly cancer, and pancreatic cancer. Cash and short-term investments totaled $911 million as of December 31, 2021. Our net loss for the fourth quarter was $47 million, or $0.45 per share, and adjusted EBITDA was negative $32 million.

Speaker Change: Our R&D spending is largely tied to the number of ongoing clinical trials at a given moment.

Speaker Change: That's the current slate of phase III trials near conclusion, we are in the process of launching our next set of trials, including lunar two and keynote <unk> eight.

Speaker Change: Following our portfolio prioritization efforts last year future R&D investments will be focused in areas of highest return GBM non small cell lung cancer and pancreatic cancer.

Speaker Change: Cash and short term investments totaled $911 million as of December 31, 2023.

Speaker Change: Our net loss for the fourth quarter and $47 million or <unk> 45 per share and adjusted EBITDA was negative $32 million.

Ashley Cordova: As we prepare for the potential to treat thousands of additional patients in the years to come, we are committed to ensuring incremental investments are allocated to areas that align with our long-term strategic vision. Our goal is to focus on growth investments in areas of highest potential return, while maintaining balance sheet strength and accelerating our path to profitability. I'd like to close today by highlighting one of our Optum geopatients, Janice Armist, of Los Angeles. In 2019, Janice moved to New York City, where she met Jess, the love of her life. Avid nature enthusiasts, Janice and Jeff were soon scaling mountains across the country together.

Speaker Change: As we prepare for the potential to treat thousands of additional patients in the years to come we are committed to ensuring incremental investments are allocated to areas that align with long term strategic vision.

Speaker Change: Our goal is to focus on growth investments in areas of highest potential return, while maintaining balance sheet strength and accelerating our path to profitability.

Speaker Change: I'd like to close today by highlighting one of our Optum GL patient.

Speaker Change: Janus of Los Angeles.

Speaker Change: In 2019, Janus moved to New York City, where she met Jeff the love of her life.

Speaker Change: Avid nature enthusiasts Jameson, Jeff where students scaling mountains across the country together.

Ashley Cordova: In March 2021, Janice was diagnosed with GBM and began treatment with Octogenome. Amid the fear and uncertainty of a GBM diagnosis, Janice and Jeff decided to pursue their path. They married and moved to California to better enjoy an outdoor life.

Speaker Change: In 2021, Janet with diagnosed with GBM and began treatment with arc <unk>.

Speaker Change: And made the fear and uncertainty of the GBM diagnosis, Jonathan Jeff decided to pursue their passion.

Speaker Change: Married and moved to California to better enjoy an outdoor lifestyle.

Operator: With OptuneGeo on Janice's shoulder, Janice and Jeff continue to scale mountains and have plans to hike and rock climb across the globe. People like Janice are a constant reminder of the impact we can make in patients' lives, helping them reach more birthdays or anniversaries or the Summit of New Mountains. With that, I'll hand the call back to the operator for questions. Thank you. 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.

Speaker Change: With Optum, Gilles and Dana's shoulder, Jonathan Jeff continue to scale and have plans to hype and rock climb across the globe.

Speaker Change: People like Janice or a constant reminder of the impact we can make in patients' lives.

Speaker Change: Helping them reach more birthdays or anniversaries or the summit of new mountain.

Speaker Change: With that I'll hand, the call back to the operator for questions.

Speaker Change: Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced.

Speaker Change: To withdraw your question. Please press star one again.

Operator: Please stand by while we compile the Q&A roster. One moment for our first question, and our first question comes from Jason Bednar of Piper Sandler. Hey, good morning. Thanks for taking the questions. Can you hear me all right?

Speaker Change: Please standby, while we compile the Q&A roster.

Speaker Change: One moment for your first question.

Speaker Change: And our first question comes from Jason <unk> of Piper Sandler.

Jason: Hey, good morning, Thanks for taking my questions can you hear me alright.

Jason M. Bednar: and, Excellent. So, Bill and Ashley, I wanted to first start with your upcoming MED-IS readout. You know, I wanted to confirm that we should see the typical headline from you when you release the data next month. And then at what venue are you planning to present the full results? And then, do you see the fact that MED-IS is using TT fields as monotherapy as an advantage or a disadvantage in this trial? Is there anything to be read into the fact that brain MEDs aren't one of the three areas where you've consolidated your clinical research activity? Sure. So, good morning, Jason.

Jason: We can.

Speaker Change: Excellent.

Jason: Bill and Ashley I wanted to first start with your upcoming readout wanted to confirm that we should see the typical headline from you in your release.

Speaker Change: The data next month.

Speaker Change: And then what venue are you planning to present the full results.

Speaker Change: Do you see the fact that medicines using Tc til therapy, as an advantage or disadvantage in this trial.

Speaker Change: Was there anything to read into the fact that brain Mets are one of the three areas, where you consolidated their clinical research activity.

Speaker Change: Sure so.

William F. Doyle: As you correctly underlined, we're all eagerly awaiting the data, and we'll be announcing the top-line results at the end of the quarter. We have not yet announced the venue for the full data presentation. When we get it cleaned up, you know, we'll be applying for those slots, but I would, of conferences. This will be in the fall season. It'll be too late for the spring season.

Speaker Change: Good morning, Jason.

Speaker Change: As you can.

Speaker Change: Presley underlined.

All eagerly awaiting.

Speaker Change: Yes.

Speaker Change: The data and we'll be announcing.

Speaker Change: Top line results.

Speaker Change: At the end of the quarter.

Speaker Change: We have not yet announced the venue for the full data presentation.

Speaker Change: Can we get it cleaned up.

Speaker Change: We'll be we'll be applying.

Speaker Change: For those slots, but I would.

Speaker Change: Davidson.

Speaker Change: Conferences this will be in the fall season.

Speaker Change: It'll be too late for the spring season.

William F. Doyle: And then, with respect to our core focused areas, we do consider this to be part of our lung program. So MEDIS is studying brain metastases from non-small cell lung cancer. This is the most common form of brain mets, and so it's well within the core that we've staked out of GBM, non-small cell lung cancer, and pancreatic cancer.

And then with respect to our.

Speaker Change: Core focused areas, we do consider this to be part of our lung program.

Speaker Change: So Matt it's a study in <unk>.

Speaker Change: <unk> metastases from non small cell lung cancer. This is the most common.

Speaker Change: Our form of brain Mets.

William F. Doyle: But the only thing I would add there is, yes, you can expect a standard press release from us, similar to how we have handled all of the other top-line data releases for this release. Okay, great. And then sorry for any background noise here, but I'll just try to ask my next question here quick. Just wanted to ask about duration of wear.

Speaker Change: So it's well within.

Speaker Change: The core that we've staked out of GBM.

Speaker Change: Small cell lung cancer and pancreatic cancer.

Speaker Change: But the only thing I would add there is yes, you can expect a standard press release from similar to how we have handled all of the other topline data releases.

Speaker Change: For the truth.

Speaker Change: Okay, Great and then sorry for any background noise here, but I'll just.

Speaker Change: Sorry to ask you a quick just wanted to ask on on duration of where I think you've been looking at a lot of ways to keep patients on therapy longer and the revenue implications could be pretty meaningful.

Jason M. Bednar: I think you've been looking at a lot of ways to keep patients on therapy longer, and the revenue from the patients could be meaningful. You have the Trident trial where you start patients earlier rather than waiting until after radiotherapy is complete. I think you talked about educating doctors and patients about the survival benefits of wearing Optune for longer throughout the day. I know you've got the new arrays. These are supposed to have some clinical benefits.

Speaker Change: Right and trial, where youre starting patients earlier, rather than waiting for lab for radiotherapy is complete I think you've talked about educating doctors and patients about the survival benefit.

Speaker Change: For longer throughout the day I know you've got the new arrays.

Jason M. Bednar: You started looking at potentially keeping patients on longer even after progression. So individually, those are all interesting. I guess collectively, they can be pretty impactful.

Speaker Change: Got some clinical benefits.

Speaker Change: You started looking at potentially keeping patients on longer even after after progression.

Speaker Change: Individually those are all interesting I guess collectively they could be pretty impactful.

Frank Leonard: Trident's not coming for a couple of years, but could we actually see benefits from some of these other items to extend duration of wear and impact revenue? Hi Jason, this is Frank Leonard. Thank you for the question. I think that, you know, and thank you for highlighting all of the activities that we have ongoing in this area that really are focused on improving how patients and physicians use Optune to extend survival. I think I'd point directly to the new arrays that have been released in our key European markets, where we are tracking and looking at a wide array of KPIs to assess performance.

Speaker Change: <unk> does not come in for a couple of years, but could we actually see benefits from some of these other right.

Speaker Change: Extend duration of impact revenue sooner.

Speaker Change: Hi, Jason This is Frank Leonard Thanks for the question I think that.

Frank Leonard: And thank you for highlighting all of the activities that we have ongoing in this area that really are focused at improving how patients and physicians use option to extend survival.

Frank Leonard: I think.

Frank Leonard: <unk> directly to the new arrays that have been released in our key European markets, where we are tracking and looking at a wide array of kpis to assess performance and what we've seen so far both in the in the metrics as well as in the anecdote is that the performance is meeting our expectation.

Frank Leonard: And what we've seen so far, both in the metrics as well as in the anecdotes, is that the performance is meeting our expectations and looking to a positive trend in patient experience. So I think collectively we have lots of opportunities to move the needles, and we'll continue to update you as the metrics come in. Okay, fair enough. Maybe one more.

Frank Leonard: <unk> and <unk>.

Frank Leonard: Looking to two a positive trend in patient experience.

Frank Leonard: So I think collectively we have lots of opportunities to move the needles and we'll continue to update you as the metrics come in.

Speaker Change: Okay Fair enough, maybe one more actually I know at one point, we had a more formal level of financial guidance.

Jason M. Bednar: Ashley, I know at one point we had a more formal level of financial guidance. We stepped away for a couple of different reasons, but it seems like the business is back to being predictable here. Are you willing to comment or offer any kind of forward-looking outlook, whether it's for this year at a high level, or if you're thinking of the next few years, what to think about for growth for the business? Thank you. Yeah, no, thanks, Jason.

Speaker Change: Stepped away for a couple of different reasons, but it seems like the business is back to being predictable here.

Speaker Change: Are you willing to comment or offer any kind of like forward looking out whether it's for this year at a high level.

Speaker Change: Thinking out over the next few years.

Speaker Change: Back to the growth for the business. Thank you.

Speaker Change: No no. Thanks, Jason I appreciate the question I mean, what we've always committed to do is providing the necessary color. So that you guys can can look ahead and I would say, where we feel like we need to provide detailed color we do.

Ashley Cordova: I appreciate the question. I mean, what we've always committed to doing is providing the necessary color so that you guys can look ahead. And I would say where we feel like we need to provide detail color, we do.

Speaker Change: So you heard our message we're focused on.

Speaker Change: A return to growth in the GBM business.

Speaker Change: We do believe we have a clean baseline in 2023 and all of our major markets upon which you can build that growth right. So.

Ashley Cordova: So you've heard our message; we're focused on, you know, a return to growth in the GBM business. We do believe we have a clean baseline in 2023 in all of our major markets upon which you can build that growth, OK. So, in Germany and the U.S., we're largely through that.

Speaker Change: Thank you in Germany, and the U S. We're largely through that as we look at 'twenty three it's a good baseline upon which not all active patient growth.

Speaker Change: In our restructuring announcements in Q4 of last year, you heard us very directly state that we think we can run the business on the residual opex.

Speaker Change: That we have which will fully support the one launch. So if you look at our Opex run rate I wouldn't expect us to be able to invest in the infrastructure, we need to launch launch at that run rate that we were running Q3 Q4.

Ashley Cordova: So if we look at 23, it's a good baseline upon which to model activation growth. And in our restructuring announcements in Q4 of last year, you heard us very directly state that we think we can run the business on the residual OffX, you know, that we have, which will then fully support the long launch. So if you look at our OffX run rate, I would expect us to be able to invest in the infrastructure we need to launch long at that run rate that we were running in Q3, Q4. So I think with those kind of anchor messages, you have what you need to build out the model, and I would say we will continue to flag if we feel there's any additional areas where we need to adjust. Okay, thanks so much.

Speaker Change: So I think with those kind of anchor messages you have what you need to be on ophthalmology and I would say we will continue to flag. If we feel there is any additional areas, where we need to adapt.

Speaker Change: Okay. Thanks, so much.

Speaker Change: Thank you one moment for our next question.

Speaker Change: And our next question comes from Jonathan Chang of Leerink partners.

Jonathan Chang: Hi, guys. Thanks for taking my questions first question ahead of a potential lung cancer approval and launch.

Jonathan Chang: Talk about the prelaunch activities that are planned and ongoing and how should we be thinking about what the initial launch trajectory could look like and then second question. Following the portfolio prioritization and strategic restructuring last year. How are you thinking about your cash position and balance sheet ahead of the two phase III readouts coming up.

Ashley Cordova: Thank you. One moment for the next question. And our next question comes from Jonathan Chang of Leering Partners. Hi guys, thanks for taking my questions.

Jonathan Chang: First question, ahead of a potential lung cancer approval and launch, can you talk about the pre-launch activities that are planned and ongoing, and how should we be thinking about what the initial launch trajectory could look like? And then, second question, following the portfolio prioritization and strategic restructuring last year, how are you thinking about your cash position and balance sheet ahead of the two phase three readouts coming up this year? If those studies are positive, are you well positioned to advance them? Thank you. Thank you for the question, Jonathan. This is Franklin.

Jonathan Chang: This year, if those studies are positive very well positioned to advance those opportunities. Thank you.

Jonathan Chang: Yes.

Speaker Change: Thank you for the question Jonathan This is frankly.

Speaker Change: The United States R. R.

Speaker Change: Our focus has been on education, and really direct engagement with potential prescribers through the advisory board process and.

Speaker Change: One of the main areas of focus is simply too.

Speaker Change: Work with the physicians to understand and acknowledge that there is a gap in the second line treatment.

Frank Leonard: In the United States, our focus has been on education and really direct engagement with potential prescribers through the advisory board process. And one of the main areas of focus is simply to work with physicians to understand and acknowledge that there is a gap in the second-line treatment of non-small cell lung cancer. And we've seen this, or we've heard this very clearly now from physicians that they are not satisfied with their options for treatment after platinum failure.

Speaker Change: In small cell lung cancer, and we've seen that we've heard that's very clearly now from physicians that.

Speaker Change: We are not satisfied with their options for treatment after platinum failure.

Speaker Change: And we think that alignment working with physicians to align on this core mutual understanding as a first step and from there we begin to educate and introduce them to tumor treating fields.

Frank Leonard: And we think that working with physicians to align on this core mutual understanding is the first step. And from there, we begin to educate and introduce them to tumor-treating fields, which we acknowledge in the medical oncology community is a new modality and we do have to go through this education process to help them understand. We're really pleased with where we are today in terms of engaging the key KOLs and preparing the plan in the U.S. to pull through. I'd also note in Germany we are also in the pre-launch phase where we are waiting for the CE mark and we've been able to engage in Germany with our key physicians through both pre-launch activities in non-small cell lung cancer but also through the launch of OptumLua for mesothelioma, really engaged in the community in Germany to to help through that education curve and ultimately to prepare the market for one, I mean, the one other thing, Jonathan, that I would just flag is that this is a medtech launch curve.

Speaker Change: Which we acknowledge and the medical oncology community is a new modality and we do have to go through this education process to help them understand.

Speaker Change: We're really pleased with where we are today in terms of engaging the key kols and preparing the plant in the U S to pull through.

Speaker Change: I'd also note in Germany. We are also in the prelaunch phase, where we are waiting for the CE, Mark and we've been able to engage in Germany with our key physicians through.

Speaker Change: Both prelaunch activities in non small cell lung cancer, but also through the launch of opting for mesothelioma.

Speaker Change: We engaged in the community in Germany, too to help through that education curve and ultimately to prepare the market for the launch.

Speaker Change: I mean, the one other thing Jonathan that I would just flag is that this is a med tech launch curve and as we look to the as we look to the models as everybody is building that then I would like to our GBM launch curve and not the stereotypical biotech curve in particular when it comes to the reimbursement.

Speaker Change: Dynamics, Yes, I think the other question you asked.

Speaker Change: With respect to our cash position for <unk>.

Frank Leonard: And as we look to the models, as everybody's building this in, I would look to our GBM launch curve and not the stereotypical biotech curve, in particular, when it comes to the reimbursement dynamic. I think the other question you asked was with respect to our cash position in preparation for these launches, and we are prepared, and it's part of our strategic plan to fully finance the non-small cell lung cancer launch that's in the budget. And as we anticipate the MEDIS readout, there is overlap between our key prescriber groups there too. So if you'll recall, MEDIS treats patients after stereotactic radiosurgery, so the radiation oncologist that we engage in our GVM business is the radiation oncologist principally who is treating these patients along with the primary medical oncologist who's treating their non-small cell lung cancer.

Speaker Change: Preparation for these launches.

Speaker Change: And we are prepared and it's part of our strategic plan to fully finance the non small cell lung cancer launch.

Speaker Change: In the budget.

Speaker Change: And as we anticipate the Metis readout again.

Speaker Change: There is overlap between our key prescriber groups there too so.

Speaker Change: If youll recall is treating patients after stereotactic radiosurgery, so the radiation oncologist.

Speaker Change: We engage in our GBS business as the radiation oncologist, principally who is treating these patients all along with the primary medical oncologists, who are treating their non small cell lung cancer.

Frank Leonard: So we believe from a cash perspective we're well covered for the non-small cell lung cancer launch and a potential launch pending the outcome of MEDIS. Thanks for taking the time to answer the question. Thank you. One moment for our next question, and our next question comes from Larry Biegelsen of Wells Fargo. Hi, good morning. It's Link calling in on behalf of Larry.

Speaker Change: So we believe from a cash perspective, we are well covered.

Speaker Change: For the non small cell lung cancer launch and a potential launch pending the outcome of notes.

Understood. Thanks for taking my questions.

Speaker Change: Thank you one moment for our next question.

Speaker Change: And our next question comes from Larry <unk> of Wells Fargo.

Speaker Change: Hi, Good morning, it's Mike calling in for Larry can you hear me okay.

Operator: Can you hear me okay? Thank you very much, everyone. Please stand by. Thanks for taking the question. The first one is, actually, you guys don't provide guidance, but you did give some color on how to think about 2024 using 2023 as a base. Can you give some more detail as far as how to think about the pace of active patient growth through 2024? Should we think about relatively balanced growth? Is there some sort of acceleration we should think about?

Mike: We can win.

Mike: Yes.

Mike: Thanks for taking out thanks for taking the question.

Mike: The first one is on.

Speaker Change: After you guys don't provide guidance you could give some color on how to think about 2024 in 2023.

Mike: <unk>.

Speaker Change: Can you give more.

Speaker Change: Some more detail as far as how to think about the pace of active patient growth through 2024 should we think about relatively balanced growth is there some sort of acceleration, we should think about and related to that.

Lea: And related to that, should we expect prescription growth as well in GBM in 2024? And any contribution from the lung we should look for in 2024? And I have a follow-up. Yeah, thanks, Lea.

Speaker Change: Should we expect prescription growth as well in GBM in 2024.

Speaker Change: The contribution from the model that we should look for in 'twenty, four and I have a follow up.

Ashley Cordova: I mean, I will reiterate what you said and I said earlier, that we do think 2023 is a clean baseline upon which we will grow in 2024. And that those levers of growth fundamentally will be active patient growth, which can come from prescription growth, can come from better conversion from scripts to starts, and can come from increasing duration, and we are focused on all of those levers. You know, transparently, we're not going to be able to give additional detail on what to expect there other than to say that, you know, you will, we do expect to see growth there. We are incentivizing our teams to grow there, and we are doing everything we can to grow there in all geographies.

Speaker Change: Yeah. Thanks, Lee I will reiterate what we what you said and I said earlier is that we do think 2023 as a clean baseline upon which we will grow in 2024.

Speaker Change: And that the levers of growth fundamentally we'll be active patient growth, which can come from prescription growth can come from better conversion from scratch two starts.

Speaker Change: And can come from increasing duration and we are focused on all of those levers.

Speaker Change: Transparently, we're not going to be able to give additional detail on what to expect here other than to say that.

Speaker Change: You will we do expect to see growth. There we are incentivizing our teams to grow there and we are doing everything we can to grow there in all geographies. How do you think as we look to France, there is room to.

Speaker Change: <unk> continued to grow off of the strong Q4, I don't take we're done seeing kind of what a mature France markets looks like but I would just say.

Speaker Change: Yes, clean 2023 baseline and yes, we are looking ahead to 2020 for Greg.

Speaker Change: Got it and any anything as far as contribution in 'twenty for his remarks.

Ashley Cordova: I do think as we look to France, there is room to, you know, continue to grow off of the strong Q4. I don't think we're done seeing kind of what a mature French market looks like, but I would just say, yes, clean 2023 baseline, and yes, we are looking ahead to 2024 growth. Got it. And anything on lung as far as contribution in 24?

Speaker Change: Yes.

Speaker Change: Just one where we will guide you being very conservative in your 2024 model, we would expect material revenue contribution in 'twenty five because of the reimbursement dynamics. So we will begin on a named patient basis, but it does take a couple of quarters to get through those first appeal cycles.

Speaker Change: We are a leading indicator of adoption there will be first prescriptions and then active patients, but really revenue will begin to materially create in 2025.

Speaker Change: Got it okay. Thanks, and then my follow up is.

Ashley Cordova: Yeah, no. I said this is one where we would guide you to be very conservative in your 2024 model; we would expect material revenue contribution in 25 because of the reimbursement dynamic. So we will begin on an aimed patient basis, but there it does take a couple of quarters to get through those first appeal cycles. So your leading indication of adoption there will be first prescriptions and then activations, but really revenue will begin to materialize in 2025. Got it.

Speaker Change: When you announced that we plan recently, you talked about keeping expenses.

Speaker Change: I can tell you reached.

Speaker Change: Our breakeven point.

Speaker Change: When we say the math, we get to something around 700 million ourselves and total revenue in order for you to reach that breakeven point and right. Now you are a little over a $500 million in total revenue can you just talk about are we thinking about it the right way as far as that sub 100 million Mark and any color you can provide on timing.

Lea: Okay, thanks. And then my follow-up question is, you know, when you announced the RE-ORG plan recently, you talked about keeping expenses kind of in check until you reach a break-even point. Now, when we did the math, we get to something around $700 million or so in total revenue in order for you to reach that break-even point, and right now, you're a little over $500 million in total revenue. Can you just talk about, are we, you know, thinking about it the right way as far as that $700 million mark, and any color you can provide on timing of that pathway and the drivers? Obviously, it's GBM, growth, and lung, but, you know, any additional color on how you get there.

Speaker Change: <unk> of that pathway and the.

Speaker Change: The drivers obviously, it's GBM growth in lung, but any additional color on how you get there. Thanks.

Speaker Change: I would say the way you summarized it very well I would say is that youre on track with your thinking I would I would agree with us.

Speaker Change: Yes.

Speaker Change: We have done the work to make sure that we're able to scale through that growth on our existing operating expenses and that includes if we look at the run rate. We were exiting Q3, the hiring of the lung for the revision.

Speaker Change: The cash that we removed out on the business in the back half of the year last year, we'll be able to fund that growth and then you are correct that that path to profitability is driven by scale.

Speaker Change: Top line growth number so I would I would say you've summarized it well.

Speaker Change: Thank you Juan.

Speaker Change: One moment for our next question.

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Yeah.

Speaker Change: Okay.

Speaker Change: And our next question comes from Emily Wagner of HC Wainwright.

Lea: Thanks. Okay, well, you summarized it very well. And so I would say, so, you know, you're on track with your thinking. I would agree with that.

Emily Wagner: Hi, good morning, Thanks for taking the questions.

Emily Wagner: Could you clarify when you're expecting the CE Mark for a second line lung in Europe.

Ashley Cordova: We have done the work to make sure that we're able to scale through that growth on our existing operating expenses. And that includes, you know, if we look at the run rate we were exiting Q3, the hiring of the loan for, you know, the cash that we removed out of the business in the back half of the year last year, we'll be able to fund that growth. And then you are correct that that path to profitability is driven by scale on a top line growth number. So I would say you've summarized it well.

Emily Wagner: How soon after that do you think you would be ready to launch and assuming that you did receive the Europe approval does that kind of increase your confidence for FDA approval. Thanks.

Emily Wagner: So.

Speaker Change: Thank you for your question.

Speaker Change: To SaaS.

Speaker Change: With the <unk>.

Speaker Change: Yes today, let's.

Speaker Change: I will say body in Europe, Alaska, Ryan and we expecting.

Ashley Cordova: Thank you. One moment for our next question, and our next question comes from Emily Bodnar of HC Wainwright: Hi, good morning.

Speaker Change: Approval.

Speaker Change: First half of this year.

Speaker Change: And what's with that.

Speaker Change: True to the FDA.

Emily Bodnar: Thanks for taking the question. Could you clarify when you're expecting the CE mark for the second line long in Europe and how soon after that you think you would be ready to launch? And assuming that you did receive European approval, does that kind of increase your confidence for FDA approval? So, thank you for the question. We submitted our materials to the not-for-profit body in Europe last July, and we are expecting approval in the first half of this year. And who was that other person? It's Rudy, yeah.

Speaker Change: Yes.

Speaker Change: So it means that the factors for the PMA.

Speaker Change: Last December and.

Speaker Change: You will see in the formation.

Speaker Change: It was filed and we guess looking therefore.

Speaker Change: Looking forward for the next step which will be the 100 day meeting.

Speaker Change: We expect it to be.

Speaker Change: And then last month.

Speaker Change: Okay.

Speaker Change: Soon after approval in Europe would you be ready to launch.

Frank Leonard: FDA will be submitting the package for the CMA. Last December, we received confirmation that it was filed, and we're just looking forward to the next step, which will be the 100-day meeting. We expect it to be a... at the end of March. Okay, how soon after approval in Europe would you be ready to launch?

Speaker Change: We will be ready to launch with the approval.

Speaker Change: Okay. Thank you.

Amit: Thank you Amit.

Amit: Okay.

Amit: And our final question comes from Vijay Kumar of Evercore ISI.

Frank Leonard: We will be ready to launch with the approval. Okay, so thank you. Thank you, One Moment. And our final question comes from Vijay Kumar of Evercore ISI. Morning. This is Kevin Nance on behalf of Vijay Kumar.

Kevin: Good morning, this is Kevin longe or D J.

One on Opex levels, you've noted.

Vijay Kumar: One on OpEx levels, you noted, a $60 million initiative in terms of OPEX savings. Inclusive of that, for the year, should we expect OPEX to grow in line with revenues, or should we see a step up given the number of clinical trials? And just to follow up, what are you expecting for free cashflow in 2024?

Vijay Kumar: A $60 million initiative.

Vijay Kumar: In terms of Opex savings inclusive of that for the year should we expect opex to grow in line with revenues or should we see a step up given the number of clinical trials and just a follow up.

Speaker Change: What are you expecting for free cash flow in 2024. Thank you.

Kevin Nance: Yeah, so again, that $60 million is intentional to enable us to be fully able to invest in both near-term growth and our long-term priorities, but it also has the happy coincidence of being sufficient to fund the lung launch and the onboarding of our large Phase III trials, which we expect to really ramp up this year, principally Lunar 2 and Keynote D58. So you should expect OPEX levels for the full year 24 to be largely in line with the full year 23, given the restructuring that we did, and I would say the same statement about cash flow.

Speaker Change: Yes, so again that 60 million his intention at all to enable that we're fully able to invest in both near term growth in our long term priorities, but it also has.

Speaker Change: The happy coincidence of being sufficient to fund the <unk> launch and the Onboarding of our large phase III trials, which we expect to really ramp up this year principally lunar two in keynote <unk>. So you should expect opex levels for the full year 2004 to be largely in line with our full year 'twenty three.

Speaker Change: Given that restructuring that we did and I would say the same statement about cash burn.

Speaker Change: Yeah.

Ashley Cordova: Got it. Thank you. And on your Lunar program, you noted a meeting with the FDA in mid-March. Do you expect to put out a press release then to let the street know about your communications with the FDA or... Would you provide any updated marketing? Yeah, I mean, we'll make sure you have...

Speaker Change: Got it thank you and on.

Speaker Change: Lunar program you noted a meeting with the FDA in mid March.

Do you expect to.

Speaker Change: Put out a press release them to lead.

Speaker Change: The Street know about your communications with the FDA or.

Speaker Change: Would you provide any updated mark.

Speaker Change: Yes, I mean, we will make sure you have.

Ashley Cordova: The material relevant information as we have it; the press release would tie to when the FDA makes formal public announcements, is what I would say. Got it. Thank you. Thank you. I would now like to turn it back to Bill Doyle for closing remarks.

Speaker Change: The material relevant information as we have it in the press release.

Speaker Change: We're tied to when the FDA has formal public announcements is what I would say.

Speaker Change: Got it thank you.

Speaker Change: Thank you I would now like to turn it back to Bill Doyle for closing remarks.

William F. Doyle: I'd like to start my closing remarks by reiterating my thanks to the Novocure team for their hard work in 2023 and for the many milestones that were achieved. Our company is bigger and more complex, but our team's dedication to our mission to help patients with very difficult diagnoses is something of which I am very proud. As exciting as 2023 was, we are looking forward to an even more exciting 2024.

William F. Doyle: I'd like to start my closing remarks.

William F. Doyle: Reiterating my thanks to the Novocure team for.

William F. Doyle: With their hard work in 2023.

William F. Doyle: And for the many milestones that were achieved.

William F. Doyle: Our company is bigger more complex.

William F. Doyle: But.

William F. Doyle: Our team's dedication to our mission to help patients with very difficult diagnosis.

William F. Doyle: Is it something of which I am.

William F. Doyle: Very proud.

William F. Doyle: As exciting as 'twenty three once we are looking forward to an even more exciting 2024.

William F. Doyle: As we've discussed, we have three fully enrolled phase 3 trials that will read out this year and one to follow. We're rolling out our next generation arrays throughout Europe and are really excited to see what's going to happen next year after we get our PMA supplement approval this year. We're going to launch it in non-small cell lung cancer, our next big indication. It's an extremely busy time, but extremely exciting. So I want to thank everyone on the call today for their continued interest in Novocure, and we look forward to reporting the results of all of these activities as the year progresses. This concludes today's conference call. Thank you for participating, and you may now disconnect. In the name of the Father, and of the Son, and of the Holy Spirit. Amen.

William F. Doyle: As we've discussed we have three fully enrolled phase III trials that will read out to this year and one to follow.

William F. Doyle: We're rolling our next generation arrays throughout Europe.

William F. Doyle: Really exciting.

William F. Doyle: After we get our PMA supplement approval this year.

And.

William F. Doyle: We're going to launch in non small cell lung cancer, our next big indications.

William F. Doyle: It's extremely busy.

William F. Doyle: Time, but extremely exciting so I want to thank everyone on the call today for their continued interest in Novocure and we look forward to reporting the results of all of these activities as the year progresses.

William F. Doyle: Yes.

Speaker Change: This concludes today's conference call. Thank you for participating and you may now disconnect.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Yes.