Q4 2020 Novocure Ltd Earnings Call

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Operator: Ladies and gentlemen, thank you for standing by, and welcome to the Novocure 4th Quarter and Full Year 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode.

Ladies and gentlemen, thank you for same day bye.

I'll take care of fourth quarter on full year of 2020 earnings conference call.

At this time all participant lines are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask the question. During the session you will need the press star one on your telephone.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero.

Please be advised the today's conference is being recorded.

Kearney further assistance please press star zero.

Operator: I would now like to hand the conference over to your speaker today, Gabrielle Ferdinand, Director of Investor Relations. Thank you. Please go ahead, ma'am.

I'd now like to hand, the consequent what's you're speaking of the day Gabrielle for Dennis.

Direct of Investor Relations. Thank you. Please go ahead ma'am.

Gabrielle Ferdinand: Good morning, everyone, and thank you for joining us to review Novocure's fourth quarter and full year 2020 performance. I am joined on the phone by our Executive Chairman, Bill Doyle, our CEO, Asaf Danziger, and our CFO, Ashley Cordova. Other members of our executive leadership team are also on the call and available for Q&A. The slides presented today can be viewed on our website, www.novocure.com, by clicking on the link for fourth quarter and full year 2020 financial results, located in the event section of our investor relations page.

Good morning, everyone and thank you for joining us to review nobody cares fourth quarter and full year 2020 performance.

I am joined on the phone by our executive Chairman Bill Doyle, our CEO of stocked on vigor and our CFO Ashley Cordova.

Other members of our executive leadership team are also on the call and available for Q&A.

The slides presented today can be viewed on our website www dot novo care dot com by clicking on the link for fourth quarter and full year 2020 financial results located in the events section of our Investor Relations page.

Gabrielle Ferdinand: 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. These statements involve a number of risks and uncertainties, some of which are beyond our control, including those risks and uncertainties described from time to time in our SEC filings.

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, including those risks and uncertainties described from time to time in our SEC filings.

Gabrielle Ferdinand: We do not intend to update publicly any forward-looking statement except as required by law. Following our prepared remarks today, we will open the line for questions. Financials for the three and 12 months ended December 31 2020 are available in our press release and in our 10k, both of which we released earlier this morning. Where appropriate, we will refer to non-GAAP financial measures to evaluate our business.

We do not intend to update publicly any forward looking statement, except as required by law.

Following our prepared remarks today, we will open the line for question.

The financials for the three and 12 months ended December 31, 2020 are available in our press release and in our 10-K, both of which we released earlier this morning.

Where appropriate we will refer to non-GAAP financial measures to evaluate our business.

Gabrielle Ferdinand: Reconciliations of Non-Gap Financial Measures to Gap Financial Measures are also included in our press release, in the appendix of the supplemental slides accompanying this presentation, and in our Form 8K filed with the SEC today. These materials can be accessed from our investor relations page on our website, www.novacare.com. With that, I will now turn the call over to Bill Doyle. Thank you, Gabby, and good morning,

Conciliation of non-GAAP financial measures to GAAP financial measures are also included in our press release in the appendix of the supplemental slides accompanying this presentation and in our form 8-K filed with the SEC today.

These materials can be accessed from our Investor Relations page of our website Www Dot Novacare dotcom.

With that I will now turn the call over to Bill Doyle.

Thank you Kathy and good morning, everyone.

William F. Doyle: We started Novocure with the novel insight that electric fields can be harnessed to disrupt cancer cell division. Two decades later, our mission remains clear. We strive to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our innovative therapy tumor-treating field. We believe we are in a virtuous cycle of innovation and execution as our commercial business generates the financial strength to invest in innovation that will fuel the future growth of our company. In 2020, our GBM business delivered nearly $500 million in annual net revenues and nearly $100 million in cash flow from operations.

We started novocure with the novel insights the electric fields can be harnessed to disrupt the cancer cell division to.

The two decades later, our mission remains clear.

Strive to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our innovative therapy tumor treating fields.

We believe we are in a virtuous cycle of innovation and execution.

As our commercial business generates the financial strength to invest in innovation that will fuel the future growth of our company.

2020, our GBM business delivered nearly $500 million in annual net revenues of nearly $100 million in cash flow from operations.

William F. Doyle: Our sustained commercial momentum allows us to continue to make significant investments in Clinical Trial Programs, Product Development Initiatives, and Ongoing Research as we work to unlock the full potential of the tumor-treating field's platform. We continued our track record of execution throughout 2020, despite the unanticipated prolonged challenges of doing business during the COVID-19 pandemic. Tumor Treating Fields is an emerging cancer treatment modality that requires significant prescriber education to drive awareness and acceptance. For nearly a year, we have relied heavily upon virtual engagement to accomplish our educational objectives.

Our sustained commercial momentum allows us to continue to make significant investments.

Our clinical trial programs.

Development initiatives and ongoing research as we worked one locked the full potential of the tumor treating fields platform.

We continued our track record of execution throughout 2020, despite the unanticipated prolonged challenges of doing business during the COVID-19 pandemic.

Tumor treating fields is an emerging cancer treatment modality that requires significant prescriber education to drive awareness and acceptance.

For nearly a year, we have relied heavily upon virtual engagements to accomplish our educational objectives.

William F. Doyle: Virtual engagement poses some challenges to effectively communicating and engaging with our health care providers and other partners around the world. Notwithstanding these challenges, we believe the fundamental value of the tumor treating fields platform remains unchanged, and our teams are undeterred in their commitment to advance our patient forward mission. Throughout 2020, we made notable progress to advance our three overarching priorities: drive commercial adoption for glioblastoma and mesothelioma, advance our clinical trials in new indications and combinations, and deliver product innovation to optimize tumor-treating field therapy. We broaden reimbursement coverage of Optune for GBM across our active market, including China's NMPA-approved opt-in for newly diagnosed and recurrent GBM.

Virtual engagement poses some challenges to effectively communicating and engaging with our health care providers and other partners around the world.

Notwithstanding these challenges we believe the fundamental value of the tumor treating fields platform remains unchanged.

And our teams are undeterred and their commitment to advance our patient forward mission.

Throughout 2020, we made notable progress to advance our three overarching priorities.

To drive commercial adoption of Glioblastoma and music the liana to.

To advance our clinical trials in new indications and combinations.

And to deliver product innovation to optimize tumor treating fields therapy.

We broadened reimbursement coverage of opportune for GBM across our active markets.

China's and the M. P. A approved opportune for newly diagnosed and recurrent GBM extending the reach of tumor treating fields therapy to the world's largest GBM market.

William F. Doyle: Extending the Reach of Tumor Treating Fields Therapy to the World's Largest GBM Market. Our clinical teams launched three new clinical trials, which expanded our clinical programs to seven actively enrolling studies involving more than 2,900 patients; we entered into two important clinical collaborations to expand the horizons of tumor treating fields research and development; and we advance multiple product innovations. Asaf Danziger, Ingrid Goldberg, Novocure Ltd.

Our clinical teams launched three new clinical trials, which expanded our clinical programs to seven actively enrolling studies involving more than 2900 patients.

We entered into two important clinical collaborations to expand the horizon of tumor treating fields of research and development.

We advanced multiple product innovations intended to optimize the delivery of tumor treating fields, notably we accomplished all of this while we grew net revenues by 41% year over year and added $516 million to our balance sheet.

William F. Doyle: Notably, we accomplished all of this while we grew net revenues by 41% year-over-year and added $516 million to our balance. I'll come back to our clinical and product development programs later this morning, but first, I want to turn to Asaf to share his perspective on the fourth quarter. Thank you, Bill.

I'll come back to our clinical and product development programs. Later this morning, but first I want to turn to our sauce to share his perspective on the fourth quarter Asaf.

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Thank you Bill I'm grateful to the Novocure team, we delivered yet another strong quarter global net revenues totaled $144 million, representing 45% growth versus the fourth quarter of 2019, our on net revenue growth was driven primarily by active patient growth.

Asaf Danziger: I'm grateful to the Novocure team who delivered yet another strong quarter. Global net revenues totaled $144 million, representing 45% growth versus the fourth quarter of 2018. Our net revenue growth was driven primarily by active patient growth and expanded reimbursement for options. We ended the quarter with more than 3,400 active patients on therapy, an increase of 17% year-over-year. We have now treated more than 18,000 patients globally. Beyond active patient growth, broadening reimbursement coverage also drove revenue growth.

And the expanded reimbursement for opportune, we ended the quarter with more than 3400 active patients on therapy and increase of 17% year over year, we have not treated more than 18000 patients globally.

Beyond the active patient growth broadening reimbursement coverage also drove revenue growth with national positive reimbursement decisions to kind of opportunities, while Germany, and Switzerland last year, we have secured broad reimbursement for GBM in all of our active markets. Most recently the Swiss federal office of public health.

Asaf Danziger: With national positive reimbursement decisions to cover Optune in Israel, Germany, and Switzerland last year, we have secured broad reimbursement for GBM in all of our active markets. Most recently, the Swiss Federal Office of Public Health added Optune in combination with hemozolomide for the treatment of newly diagnosed GBM to the list of remedies and equipment, which establishes national reimbursement for Optune effective April 1, 2021.

<unk> added the opportune in combination with the Mozilla mine for the treatment of newly diagnosed GBM to the least the frame of DS and equipment, which establishes national reimbursement for opportune effective April 1st 'twenty 'twenty. One this decision represents an incredible effort by our team to expand access to our therapy.

Asaf Danziger: This decision represents an incredible effort by our team to expand access to our therapy, as well as increased recognition of Optune's benefits among health insurers. Our performance last year underscores the resilience and innovative capacity of the Novocure team during what was a challenging year across our industry. We believe the prolonged disruption caused by COVID-19 continues to cause increased volatility across global healthcare systems. For example, we have seen fluctuations in the timing of surgeries and radiation therapy in certain regions, which have had some influence on the eligible patient population for Optium.

As well as increasing recognition of options benefits among health insurers.

Our performance last year underscores the resilience and innovative capacity of the Novocure team doing the what was a challenging you of course, our industry. We believe the prolonged disruption caused by COVID-19 continues to cause increased volatility across global health care system.

For example, we have seen fluctuations in the timing of surgeries and radiation therapy in certain regions, which have had some influence on the eligible patient population for <unk>. Since last March we of educated our physicians largely via zoom on conference calls.

Asaf Danziger: Since last March, we have educated our physicians largely via Zoom and conference calls. However, remote interaction has posed some challenges to our ability to engage healthcare providers and partners around the world, despite our efforts to minimize the impact of COVID-19 on our day-to-day operations. Looking forward, we see room for significant growth in our commercial business. Our current penetration rates for GBM range from 30 to 40% globally.

Out of interaction has posed some challenges to our ability to engage healthcare providers and partners around the world. Despite our efforts to minimize the impact of COVID-19 on our day to day operations.

Looking forward, we see room for significant growth in our commercial business. Our current penetration rates for G. P. A M range from 30% to 40% globally. We remain focused on driving further penetration through increased engagement with leading academic institutions and continued physician education efforts.

Asaf Danziger: We remain focused on driving further penetration through increased engagement with leading academic institutions and continued physician education efforts, particularly among radiation oncologists. We are also working to expand access to our approved indications in new markets. We plan to launch options for GBM in France next and recently submitted a full reimbursement package to the French Ministry of Health to establish reimbursement coverage. We are actively evaluating market access pathways to enter additional European markets for our currently marketed indications prior to the expected launch of future indications.

Particularly among of the Asian oncologists.

We are also working to expand access to our approved indications in new markets. We plan to loans opportune for G. B M. In France next and recently submitted our full reimbursement package to the French Ministry of health to establish reimbursement coverage. We are actively evaluating the market access pathways.

To enter additional European markets for our currently marketed indications prior to the expected loans of future indications, we look forward to providing further updates on future calls.

Asaf Danziger: We look forward to providing further updates on future calls. As part of our development strategy, we are committed to further extending the survival of patients in our approved indications. In December 2020, we enrolled the first patient in our randomized Phase IV Trident trial in newly diagnosed GBM. Trident tests the potential survival benefit of initiating optium plastimozolemide concurrently with radiation therapy versus following the completion of chemoradiation. Trident is supported by preclinical work that shows TT fields increase sensitivity to radiation therapy and inhibit DNA damage repair.

As part of our development strategy, we are committed to further extending survival of patients in our approved indications.

In December 2020, we enrolled the first patients in a randomized faithful tried in trial in newly diagnosed GBM tried them tests the potential survival benefit of initiating opportune presti Mazola mind concurred with what the Asian therapy versus following the completion of chemo radiation Trident is supported.

The preclinical work that showed the TT fields increased sensitivity throughout the Asian therapy, and the inhibitor DNA damage repair Trident is designed to detect an extension in overall survival of approximately six months with nearly 100, leading institutions committed to participate in the study.

Asaf Danziger: Trident is designed to detect an extension in overall survival of approximately six months. With nearly 100 leading institutions committed to participate in the study, Trident offers the opportunity to engage further with academic centers that conduct GBM research. I want to reiterate how proud I am of the progress made by the Novocure team throughout this challenging year. To those colleagues listening on the call today, thank you for your commitment to our patient-forward mission. With that, I will turn the call back to Bill to provide more detail about our development pipeline. Thank you, Asaf.

<unk> offers the opportunity to engage further with academic centers that the conduct of G. B M research.

I want to reiterate how proud I M of the progress made by the Novocure team throughout the challenging U two those colleagues listening on the call today. Thank you for your commitment to our patients forward mission.

With that I will turn the call back to bill to provide more detail about our development pipeline.

Thank you Asaf.

William F. Doyle: Our belief that the tumor treating field's mechanism of action is broadly applicable to solid tumor cancers is supported by a scientific rationale grounded in 20 years of research. As proud as we are of the scientific progress we have made, we believe we are only beginning to realize our potential to improve outcomes in oncology. In 2020, we invested over $130 million in research and development, and we expect to continue to utilize our financial strength to advance our multi-pronged development strategy.

Our beliefs that the tumor treating fields mechanism of action is broadly applicable to solid tumor cancers is supported by a scientific rationale grounded in 20 years of research.

As proud as we are of the scientific progress. We have made we believe we are only beginning our potential to improve outcomes in oncology.

In 2020, we invested over $130 million and research and development and we expect to continue to utilize our financial strength to advance our multi pronged development strategy.

William F. Doyle: This includes generating clinical data to establish the safety and efficacy of tumor treating fields and new indications, and in combination with other effective therapies, to identify their optimal use and approved indications, and to optimize our therapy through product innovation.

This includes generating clinical data to establish the safety and efficacy of tumor treating fields in new indications and in combination with other effective therapies.

To identify tumor treating fields optimal use in approved indications.

And to optimize our therapy through product innovation.

William F. Doyle: Our teams are enrolling patients in 7 ongoing clinical trials in ovarian cancer, brain metastases, non-small cell lung cancer, pancreatic cancer, gastric cancer, and glioblastoma. In all of our trials, we remain focused on driving enrollment by increasing site engagement at our active clinical trial sites and by expanding our global footprint with new sites. Although we continue to see persisting uncertainty and volatility across health care systems from COVID-19, we are confident in our globally aligned response and continue to monitor the situation closely.

Our teams are enrolling patients in seven ongoing clinical trials in ovarian cancer brain metastases, non small cell lung cancer pancreatic cancer gastric cancer and Glioblastoma.

And all of our trials, we remain focused on driving enrollment by increasing site engagement at our active clinical trial sites and by expanding our global footprint with new sites.

Although we continue to see persisting uncertainty and volatility across health care systems from COVID-19, we are confident in our globally aligned response plans and continue to monitor the situation closely.

William F. Doyle: Advancing the clinical pipeline is among our highest priorities, and we will continue to refine our systems and processes as needed to realize the substantial growth opportunity that our current development programs offer. Our existing pipeline programs create the potential to extend the reach of tumor-treating fields therapy to many more cancer patients, with multiple data readouts anticipated over the next few years. We expect news flow from our thoracic and abdominal cancer programs this year, beginning with final data from HEPA-NOVA, our Phase 2 pilot trial in advanced liver cancer.

Advancing the clinical pipeline is among our highest priorities and we will continue to refine our systems and processes as needed to realize the substantial growth opportunity that our current development programs offer.

Our existing pipeline programs create the potential to extend the reach of tumor treating fields therapy to many more cancer patients with multiple data readouts anticipated over the next few years.

We expect news flow from our surace can abdominal cancer programs. This year, beginning with final data from <unk>, our phase II pilot trial in advanced liver cancer we.

William F. Doyle: We are currently finalizing data collection and plan to present the results of the study at an upcoming medical meeting. Additionally, three of our Phase III Pivotal Trials have enrollment-driven interim analyses, all of which we expect to occur in the next 18 months. Beginning with our Abdominal Cancer Program, our Innovate III trial tests the effectiveness of tumor-treating fields with weekly paclitaxel in 540 patients with platinum-resistant ovarian cancer. Ovarian cancer ranks fifth in cancer deaths among women in the U.S. Almost all patients with recurrent ovarian cancer ultimately develop platinum-resistant disease, and the prognosis for this population remains poor.

We are currently finalizing data collection and plan to present the results of the study at an upcoming medical conference.

Additionally, three of our phase III pivotal trials of enrollment driven interim analyses all of which we expect to occur in the next 18 months.

Beginning with our abdominal cancer program.

Our innovate three trial testing the effectiveness of tumor treating fields with weekly Paclitaxel in 540 patients with platinum resistant ovarian cancer.

Ovarian cancer ranks fifth in cancer deaths among women in the U S. Almost all patients with recurrent ovarian cancer ultimately develop platinum resistance and the prognosis for this population remains poor.

William F. Doyle: Innovate 3 is designed to detect extension and overall survival of approximately four months, equating to a hazard ratio of 0.75. Given current enrollment trends, we now project that ovarian cancer will be the first indication from our current late-stage pipeline to reach interim analysis. We continue to anticipate final data from Innovate3 in 2023, approximately 18 months after the last patient is enrolled in the study. Protocol specified, and Enrollment-Driven Interim Analysis at Last Patient, which we expect will occur in the third quarter of 2021. European Network for Gynecological-Oncological Trials and the GOG Foundation

Innovate three is designed to detect the extension in overall survival of approximately four months equating to a hazard ratio of 0.75.

Given current enrollment trends, we now project that ovarian cancer will be the first indication from our current late stage pipeline to reach interim analysis.

We continue to anticipate final data from innovate three in 2023, approximately 18 months. After the last patient is enrolled in the study.

The protocol specifies an enrollment driven interim analysis at last patient in which we expect will occur in the third quarter of 2021.

The European network for Gynecological Oncological trial groups and the G. O G Foundation third party clinical trial of networks are collaborating with us to facilitate enrollment at.

William F. Doyle: Third Party Clinical Trial Networks are collaborating to facilitate enrollment at Leading Cancer Center. These collaborations highlight the growing support for tumor treating fields across the global clinical community. We continue to enroll patients in our PANOVA 3 trial in locally advanced pancreatic cancer, for which we anticipate final data in 2023. Moving on to our thoracic cancer program. Our lunar trial tests the effectiveness of tumor-treating fields with physician's choice of an immune checkpoint inhibitor or docetaxel for the second-line treatment of patients with stage 4 non-small cell lung cancer who progressed during or after platinum-based therapy. Because of the evolving standard of care for second-line treatments for non-small cell lung cancer. Lunar was designed to generate data that contemplated multiple outcomes.

At leading cancer centers.

These collaborations highlight the growing support for tumor treating fields across the global clinical community.

We continue to enroll patients in our P&L of the three trial in locally advanced pancreatic cancer for which we anticipate final data in 2023.

Moving to our thoracic cancer program, our lunar trial testing the effectiveness of tumor treating fields with physician's choice of immune checkpoint inhibitor or docetaxel. The second line treatment of patients with stage four non small cell lung cancer progressed during or after platinum based therapy.

Because of the evolving standard of care for second line treatment of non small cell lung cancer lunar was designed to generate data that contemplates multiple outcomes all of which we believe will be clinically meaningful for patients the <unk>.

William F. Doyle: All of which we believe will be clinically meaningful for patients. The study is designed to detect an extension in overall survival of approximately four months, equating to a hazard ratio of 0.76. We anticipate final data from Lunar in 2023, approximately 18 months after the last patient is enrolled. The protocol specifies an enrollment-driven interim analysis at 432 patients, which we expect will occur in the fourth quarter of 2021. Tumor treating fields are intended for use principally in combination with other standard of care treatments.

Studies designed to detect an extension of the overall survival of approximately four months equating to a hazard ratio of 0.7 sites.

We anticipate final data from lunar in 2023, approximately 18 months after the last patient is enrolled.

The protocol specifies of enrollment driven interim analysis at 432 patients, which we expect will occur in the fourth quarter of 2021.

Tumor treating fields is intended for use principally in combination with other standard of care treatments and we look forward to expanding our lung cancer program later this year.

William F. Doyle: And we look forward to expanding our lung cancer program later this year. In 2020, we entered into a clinical trial collaboration with MSD, a trade name of Merck, to develop tumor-treating fields together with the anti-PD-1 therapy, Katruda, for the treatment of first-line non-small cell lung diseases. This trial is an important expansion of our clinical development into stage 3 first-line non-small cell lung cancer with a global leader in on

In 2020, we entered into a clinical trial collaboration with MST of trade name of Merck to develop tumor treating fields together with the anti PD one therapy keytruda for the treatment of first line non small cell lung cancer.

This trial is an important expansion of our clinical development into stage III first line non small cell lung cancer with a global leader in oncology.

William F. Doyle: Keynote B36 is designed to enroll 66 patients in the U.S. and is expected to launch in the second quarter of 2021. In addition to our clinical efforts, we've increased our investment in product development initiatives intended to extend survival and maintain quality of life for patients.

<unk> B 36 is designed to enroll 66 patients in the U S and expected to launch in the second quarter of 2021.

In addition to our clinical efforts, we've increased our investment in product development initiatives intended to extend survival and main pain quality of life for patients.

William F. Doyle: Our product development teams made tremendous strides in 2020 and remain focused on delivering product innovations that prioritize initiatives to increase tumor treating fields dose and patient ease of use. Our teams continue to evaluate opportunities to optimize the tumor treating fields generated, design new arrays that are more flexible and can deliver higher tumor treating field intensities, and create new patient-centered software intended to support larger populations in multiple indicators. All of the research and development underway, both at Novocure and within the global scientific community, build upon and enrich the tumor treating fields ecosystem.

Our product development teams made tremendous strides on 2020 and remained focused on delivering product innovations that prioritized initiatives to increase tumor treating fields dose and patient ease of use.

Our teams continue to evaluate opportunities to optimize the tumor treating fields generator does.

The new arrays that are more flexible and can deliver higher tumor treating fields intensities and create new patient centered software intended to support larger populations in multiple indications.

All of the research and development underway, both at Novocure and within the global scientific community.

On the PON and enrich the tumor treating fields ecosystem.

Translational research clinical development and product innovation programs propel our efforts to expand the approved indications for tumor treating fields therapy.

William F. Doyle: Translational research, clinical development, and product innovation programs propel our efforts to expand the approved indications for tumor treating fields therapy. Research grants support in vivo, in vitro, and other preclinical projects conducted by scientists around the globe, and Investigator-sponsored trials expand our understanding of tumor-treating fields' optimal use in the clinic. All of these efforts are in the service of patients as the ecosystem drives to extend survival in some of the most aggressive forms of cancer.

Research grant support in of vivo in of vitro and other preclinical projects conducted by scientists around the globe.

And investigator sponsored trials expand our understanding of tumor treating fields optimal use in the clinic.

All of these efforts are in the service of patients as the ecosystem drives to extend survival in some of the most aggressive forms of cancer.

I will now turn the call over to Ashley to discuss our financial results.

Thank you Bill.

Novocure further strengthened its financial position in 2020, driven by the disciplined execution of our team.

We delivered annual net revenues of $494 million, representing a 41% increase versus 2019.

William F. Doyle: I will now turn the call over to Ashley to discuss our financial results. Thank you, Bill. Novocure further strengthened its financial position in 2020 driven by the disciplined execution of our strategy. We delivered annual net revenues of $494 million, representing a 41% increase versus 2019.

This is the seventh consecutive year, we have reported at least double digit revenue growth.

Our investments in R&D reached $132 million in 2020, increasing 67% year over year.

We remain committed to supporting the continued advancement of tumor treating field science and technology and expect investment to increase as we advance our mission to the extend survival and the cancers that we treat.

Ashley Cordova: This is the seventh consecutive year we have reported at least double-digit revenue growth. Our investments in R&D reached $132 million in 2020, increasing 67% year over year. We remain committed to supporting the continued advancement of tumor treating field science and technology and expect investments to increase as we advance our mission to extend survival and the cancer sites we treat. In the fourth quarter, our financial strength enabled the repayment of an outstanding $150 million long-term loan, which we replaced with a three-year secured revolving credit facility at a significantly lower carrying cost. We also closed a $575 million zero percent convertible senior note due in 2025. We ended the year with $843 million in cash on hand.

In the fourth quarter, our financial strength enabled the repayment of an outstanding 150 million dollar long term loans, which we replaced with a three year secured revolving credit facility at a significantly lower carrying cost.

We also closed a $575 million zero percent convertible senior note due in 2025.

We ended the year with $843 million in cash on hand.

The capital structure, we have put in place and our improved profitability position us well for an anticipated period of significant innovation and growth over the next few years.

We remain committed to making the investments needed to advance our development program intended to increase the acceptance of tumor treating field and in our commercial infrastructure prior to the future potential launches in multiple solid tumor indications.

Specific to the fourth quarter, our GBM business delivered of $144 million and net revenue for the quarter, representing a 45% year over year increase.

Ashley Cordova: The capital structure we have put in place and our improved profitability position us well for an anticipated period of significant innovation and growth over the next few years. We remain committed to making the investments needed to advance our development program intended to increase acceptance of tumor treating fields and in our commercial infrastructure prior to future potential launches in multiple solid tumor indications. Specific to the fourth quarter, our GBM business delivered $144 million in net revenues for the quarter, representing a 45% year-over-year increase.

Our gross and net revenues was driven by an increase in half the patients in our active markets.

And an improvement in the net revenue booked per active patient, particularly in the U S.

Moving down the P&L gross profit in the fourth quarter was $116 million, reflecting in the 80% gross margin.

Gross margin continues to benefit from ongoing efficiency initiatives and increasing scale.

Gross margin is also on <unk> with revenue, resulting from the successful appeal of previously denied claims from Medicare fee per service beneficiary and pinpoint byproduct sales to die.

Ashley Cordova: Our growth in net revenues was driven by an increase in activations in our active markets and an improvement in the net revenues booked per activation, particularly in the U.S. Moving down the P&L, gross profit in the fourth quarter was $116 million, reflecting an 80% gross margin. Growth Margin continues to benefit from ongoing efficiency initiatives and increasing scale. Gross margin is also improved with revenue resulting from the successful appeal of previously denied claims for Medicare Fee-for-Service beneficiaries and tempered by product sales design.

Given the clear organic growth opportunity, we have in hand, we remain committed to investing strategically to maximize the growth potential of the tumor treating fields platform.

Our continued commercial execution and actions to solidify the balance sheet allows us to invest a record $44 million and research and development in the fourth quarter, bringing the total to $132 million for the full year.

For the full year this represents 67% growth versus 2019.

We expect growth in our research and development investment to continue into 2021, as we work to advance our pipeline programs and increased acceptance of tumor treating fields across the global oncology community.

Ashley Cordova: Given the clear organic growth opportunity we have in hand, we remain committed to investing strategically to maximize the growth potential of the tumor treating fields platform. Our continued commercial execution and actions to solidify the balance sheet allowed us to invest a record $44 million in research and development in the fourth quarter, bringing the total to $132 million for the full year. For the full year, this represents 67% growth versus 2019.

Because of the scale and growth of our research and development program, Let me spend a few moments highlighting where we are making investments.

For the full year 2020, we invested $54 million to advance our clinical development program, including the launch of three new clinical trials.

Our 2020 clinical development programs investment represents a 64% year over year increase versus 2019.

Ashley Cordova: We expect growth in our research and development investments to continue into 2021 as we work to advance our pipeline programs and increase acceptance of tumor treating fields across the global oncology community. Because of the scale and growth of our research and development program, let me spend a few moments highlighting where we are making investments. For the full year 2020, we invested $54 million to advance our clinical development program, including the launch of three new clinical trials.

Our medical affairs efforts to educate the clinical community about tumor treating field accounted for $21 million of our total R&D expenses, reflecting a 36 per cent year over year increase.

We also invested $12 million, a 76% annual increase to support preclinical and basic research to further refine our understanding of the tumor treating fields mechanism of action and at the optimal yet.

Lastly, we nearly doubled our investments in product innovation intended to optimize the delivery of tumor treating fields therapy to a total of $10 million for the year.

Ashley Cordova: Our 2020 Clinical Development Program's investment represents a 64% year-over-year increase versus 2019. Additionally, our medical affairs efforts to educate the clinical community about tumor treating fields accounted for $21 million of our total R&D expenses, reflecting a 36% year-over-year increase. We also invested $12 million, a 76% annual increase, to support preclinical and basic research to further refine our understanding of the tumor-treating field's mechanism of action and its optimal use.

We remain committed the balancing our investments in research and development with our organizational capacity to effectively execute our strategic initiatives.

Our net income for the fourth quarter was $5 million with five states and earnings per share with $20 million and net income in 2000 and earnings per share for the full year 2020.

While optimizing R&D investments to drive long term growth is of higher priority than short term EPS generation I M.

I'm extremely proud of the profitable business we are building.

Beyond EPS, we also evaluate our operating performance based on adjusted EBITDA, a non-GAAP measure of earnings before interest taxes, depreciation amortization and share based compensation.

Ashley Cordova: Lastly, we nearly doubled our investments in product innovation intended to optimize the delivery of tumor-treating field therapy to a total of $10 million for the year. We remain committed to balancing our investments in research and development with our organizational capacity to effectively execute our strategic initiative. Our net income for the fourth quarter was $5 million, with $0.05 in earnings per share. We expect $20 million in net income and $0.20 in earnings per share for the full year 2020.

We believe this is an important metric as it removes the impact of earnings attributable to our capital structure tax rate and material noncash items, specifically share based compensation and the best reflects the financial value generated by our business.

In the fourth quarter adjusted EBITDA increased by 101 per cent to $35 million from $17 million for the same period in 2019.

Ashley Cordova: While optimizing R&D investments to drive long-term growth is of higher priority than short-term EPS generation, I am extremely proud of the profitable business we are building. Beyond EPS, we also evaluate our operating performance based on adjusted EBITDA, a non-gap measure of earnings before interest, taxes, depreciation, amortization, and share-based compensation. We believe this is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material non-cash items, specifically share-based compensation, and it best reflects the financial value generated by our business.

This improvement in fundamental financial performance was driven by net revenue growth coupled with the disciplined management of expenses.

Securely within SG&A, where we remain focused on driving operating leverage.

Moving forward, we are committed to balancing profitability with investments in future growth.

Before I hand, the call over to the operator for Q&A I would like to thank everyone on the phone for their continued interest and Novacare.

Our team delivered another strong year of financial performance under difficult circumstances.

We remain well positioned to continue investing in the advancement of our clinical and product development programs.

Ashley Cordova: In the fourth quarter, adjusted EBITDA increased by 101% to $35 million from $17 million for the same period in 2019. This improvement in fundamental financial performance was driven by net revenue growth coupled with the disciplined management of expenses, particularly within SG&A, where we remained focused on driving operating leverage. Moving forward, we are committed to balancing profitability with investments and future growth. Before I hand the call over to the operator for Q&A, I would like to thank everyone on the phone for their continued interest in Novocure. Our team delivered another strong year of financial performance under difficult circumstances.

And an organizational readiness efforts geared to sustained long term growth and maximize shareholder value.

We believe that the fundamental prospects of our business are strong and we remain confident in our team our strategy and the long term potential of the tumor treating fields platform to extend survival in some of the most aggressive forms of cancer.

Thank you for your time. This morning, now I will turn the call back over to the operator for questions.

Thank you as a reminder to ask the question you will need the press star one on your telephone to ensure your question press the pound key.

The standby, while we compile the Q&A roster.

Our first question comes from Jason Bednar with Piper Sandler Your line is open.

Hey, good morning, everyone and thanks for all of the color here on the pipeline this morning.

Ashley Cordova: We remain well positioned to continue investing in the advancement of our clinical and product development programs and in organizational readiness efforts geared to sustain long-term growth and maximize shareholder value. We believe that the fundamental prospects of our business are strong, and we remain confident in our team, our strategy, and the long-term potential of the tumor-treating fields platform to extend survival in some of the most aggressive forms of care. Thank you for your time this morning.

Bill.

Alright, I guess anyone but.

You'd laid out new trial site targets for some of your phase III study of the year ago that would really help accelerate the enrollment process.

Covid.

Truly made it more challenging here, but what's the right way to think about the gating factors in the trial milestone updates you're making today what are the variables, you're considering that could shift that timing further forwards or backwards off of any of these updates today, then I got one follow on.

Good morning, Jason just checking can everyone hear me.

We can't hear you.

Terrific.

As has been the case for the last couple of calls I'm joined by my team from around the World.

Operator: Now, I will turn the call back over to the operator for questions. Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key.

So I will be doing a little bit of.

M seeing.

As we answered the various questions.

But I would say generally and this is consistent with the.

What we have described before whenever we start of trial.

Operator: Please stand by while we compile the Q&A roster. Our first question comes from Jason Bednar with Piper Sandler. Your line is open. Hey, good morning, everyone.

We make of projections, which is essentially an educated guess.

About how that trial.

We'll recruit.

Jason M. Bednar: Thanks for all the color here on the pipeline this morning. Bill, or I guess anyone, but you laid out new trial site targets for some of your Phase 3 studies a year ago that would really help accelerate the enrollment process. You know, COVID clearly made that more challenging here, but what's the right way to think about the gating factors in the trial milestone updates you're making today? You know, what are the variables you're considering that could shift that timing, you know, further forwards or backwards off of any of these updates today? Then I got one follow up. Good morning, Jason. I'm just checking. Can everyone hear me?

We start opening centers.

We constantly gauge and.

And engage with those centers too.

To monitor enrollment in order to hit our targets and inevitably as we progress.

Progress.

For all kinds of reasons the investigators moved from one site to another.

We have some sites that the.

Over perform in terms of recruitment and other sites that underperform and as we proceed we're able to get a sense of exactly.

How many sites we need in order to achieve the targets some.

Times, its more sites, sometimes it's fewer sites.

In the Covid World.

William F. Doyle: Okay, terrific. As has been the case for the last couple of calls, I'm joined by my team from around the world, so I will be doing a little bit of emceeing as we answer the various questions. But I would say generally, and this is consistent with what we have described before, whenever we start a trial, we make a projection, which is essentially an educated guess about how that trial will recruit. We start opening centers.

That has more often been a requirement for more.

More sites, just because of the challenges.

That particular sites have in.

And engaging with their patients and the opening new protocols and some of that's been.

In specific specifically on the ovarian cancer trial.

It's actually.

William F. Doyle: We, the Unknown Executive, Asaf Danziger, Ingrid Goldberg, Novocure Ltd., for all kinds of reasons. Investigators move from one site to another. We have some sites that overperform in terms of recruitment, and other sites that underperform. And as we proceed, we're able to get a sense of exactly how many sites we need in order to achieve the targets. Sometimes it's more sites; sometimes it's fewer sites.

Occurred faster.

Than we projected so we haven't changed in terms of our late.

Late stage pipeline, we haven't changed the targets for the.

For the completion of those trials.

We are opening centers notwithstanding the challenges of the pandemic and we did open.

The trial site.

Last quarter on the quarter before that.

And so.

William F. Doyle: In the COVID world, that has more often been a requirement for more, more sites, just because of the challenges that particular sites have in engaging with their patients and opening new protocols, and some that have been, specifically in the ovarian cancer trial, occurred faster than we projected. So we haven't changed in terms of our late stage pipeline, nor have we changed the targets for the completion of those trials. We are opening centers, notwithstanding the challenges of the pandemic, and we did open trial sites last quarter in the quarter before that.

As I said the business is the highest priority in the company are certainly among the highest priorities on the company.

We're we're determined again notwithstanding any challenges to.

To bring this therapy to the patients in these other cancers.

Okay, that's really helpful Bill maybe.

Maybe just to follow up.

The bigger picture bigger picture question here wondering if you could offer maybe some high level thoughts about how are you on the team are prioritizing advancing the current trial work that's underway vs back filling the pipeline with the kind of the next wave of studies and you obviously saw a lot come during the during 2020 on the <unk>.

William F. Doyle: And so, you know, as I said, this is the highest priority in the company, or certainly among the highest priorities in the company, and we're determined, again, notwithstanding any challenges, to bring this therapy to the patients in these other. Okay, that's really helpful, Bill.

Terms of new phase twos, but.

You do have a quite of preclinical data under your belt I mean is there a preference from the novocure team for extended the new indications versus doubling down on existing indications like we've seen with some of the recent efforts I know breast cancers come up frequently the possible option.

William F. Doyle: Maybe just to follow up, maybe a bigger picture question here, wondering if you could offer maybe some high-level thoughts about how you and the team are prioritizing advancing the current trial work that's underway versus backfilling the pipeline with kind of the next wave of studies. And we obviously saw a lot come during 2020 in terms of new Phase IIs, but you do have a lot of preclinical data under your belt. Is there a preference from the Novocure team for expanding new indications versus doubling down on existing indications like we've seen with some of the recent efforts? I know breast cancer has come up frequently as a possible option where you've seen some good preclinical outcomes.

<unk> seen some good preclinical outcomes.

Just curious how youre thinking about that option and again, it's more of a bigger picture items.

Yes.

We're quite fortunate at Novocure and that are our platform tumor treating fields offers so much opportunity.

It offers the opportunity to treat.

Virtually all solid tumor cancers.

And it offers.

On the opportunity to.

To be combined with all of the emerging pharmacological therapies and we know we can continue to improve it through technological innovation and those are essentially our highest priorities.

William F. Doyle: So I guess I'd just curious how you're thinking about that option again as more of a bigger picture item. Yeah, I mean, we're quite fortunate at Novocure in that our platform, Tumor Treating Fields, offers so much. It offers the opportunity to treat virtually all solid tumor cancers, and it offers the opportunity to be combined with all the emerging pharmacological therapies.

In response to your specific question advancing our late stage pipeline is up.

Among the highest priorities from the company there is no.

<unk> for new indications.

The indications that we have in the late stage are large.

William F. Doyle: And we know we can continue to improve it through technological innovation. And those are essentially our highest priorities. But in response to your specific question, advancing our late-stage pipeline is among our highest priorities. There is no preference for new indications.

On the trials of our base on.

Science.

And phase two data that are extremely promising.

And our goal is to get those trials done evaluate the data.

And get these and get the therapy as I said the patients.

And with different teams were on.

William F. Doyle: The indications that we have in the late stage are large, the trials are based on Science and Phase II data that are extremely promising, and our goal is to get those trials done, evaluate the data, and get the therapies, I said, to patients. That's it, different teams; we're also not going to stop there.

Also not going to stop there.

We're going to backfill.

I may on mature backfill has the right.

Verb share, but we're going to continue.

The two to fill the pipeline.

That is a different set of.

Teams and Thats one of the things our financial strength has allowed.

William F. Doyle: We're going to backfill. I'm not sure backfill is the right verb here, but we're going to continue to fill the pipeline with a different set of teams.

Which is the ability to do both.

But it's not as if.

One group is thinking on Monday about recruiting the late stage trials and then they have to switch on Tuesday to think about what's going to come next.

William F. Doyle: And that's one of the things our financial strength has allowed, which is the ability to do both. But it's not as if one group is thinking on Monday about recruiting for the late stage trial, and then they have to switch on Tuesday to think about what's going to come next. The teams that are focused on the late stage trials are dedicated to recruiting those trials. All right, that's great. Thanks so much, Bill.

The teams that are focused on the late stage trials are dedicated to recruiting those trials.

Alright, that's great. Thanks, so much bill.

Thank you. Our next question comes from Gregg Gilbert with true Securities. Your line is open.

Thank you. Good morning, first maybe Ashley can you help us with any safety tips on how to model R&D on a quarterly basis going forward after that very strong.

Fourth quarter, and then bill or team since the first phase III data point investors will be highly focused on is the ovarian interim can you give us a little backgrounder on the treatment options as they currently exist there.

William F. Doyle: Thank you. Our next question comes from Greg Gilbert with Truist Security. Your line is open.

Gregory Daniel Fraser: Thank you. Good morning. First, maybe, Ashley, can you help us with any safety tips on how to model R&D on a quarterly basis going forward after that? Very strong. And then Bill or team, since the first phase three data point investors will be highly focused on is the ovarian interim, can you give us a little background on the treatment options as they currently exist there, and whether there's sort of any fluidity in those guidelines, like we're seeing.

Or whether there's sort of any fluidity and those guidelines like we're seeing in low maybe just to set the stage on.

Yes.

How patients are being treated in that setting and then lastly, bill I realize you have so many leads to follow up on in the oncology setting but are you on directing any of your basic research efforts outside of oncology or would you plan to leave that academics and others over time. Thanks.

Gregory Daniel Fraser: Maybe just to set the stage, how patients are being treated in that setting. And then lastly, Bill, I realize you have so many leads to follow up on in the oncology setting, but are you directing any of your basic research outside of oncology, or would you plan... I'm going to leave that to academics and others over time. Thanks.

Sure So Ashley why don't you.

Checkup Greg's first question on our R&D investment and then we'll and then the Ali.

We'll discuss ovarian cancer and the standard of care and how we expect to complement it.

Great. Thanks, Greg. Thanks for the question because this is an important one as we look to how the street is modeling of from the out years. As you guys know, we don't guide, but we have been clear in saying that we invested $132 million on R&D in 2020, and we expect an accelerated pace on the best and in 2021. This is on.

William F. Doyle: Sure, so Ashley, why don't you take up Greg's first question on our R&D investment, and then we'll, and then Ellie will discuss ovarian cancer and the standard of care and how we expect to complement it. Great. Thanks, Greg. Thanks for the question. Because this is an important one as we look at how the street is modeling us in the outdoors.

Our cleaners priority of the company to invest as effectively and as aggressively as possible to advance a pipeline of activities and so I would expect that $132 million certainly to grow.

Ashley Cordova: You know, as you guys know, we don't guide, but we have been clear in saying that we invested $132 million in R&D in 2020, and we expect an accelerated pace of investment in 2021. You know, this is CLEAR's priority at the company to invest as effectively and as aggressively as possible to advance these pipeline activities. And so I would expect that $132 million certainly to grow, you know, honestly, as quickly as we can effectively do it. And that is, you know, something that we'll need to do. Ashley, we lost you. Can you hear me?

Honestly as quickly as we can effectively do it and that is something that will need to be.

Ashley we lost you.

Up.

Can you hear me.

Now you are back.

Okay did you hear on the answer to the question.

We heard half of it.

Alright, well said the summary, Greg was that we certainly wanted to that of 132 million should grow. This is our area of greatest focus of the company and we want to be clear to everybody on this call. But this is we're making every investment we can effectively mick on the R&D pipeline.

Okay, Great and <unk>, maybe you can pick up the question about the.

Ashley Cordova: Now you're back. Yep. Okay. Did you hear the answer to the question? We heard half of it.

Ashley Cordova: All right, so the summary, Greg, was that we certainly want that $132 million to grow. This is our area of greatest focus at the company, and we want to be clear to everybody on this call that we're making every investment we can effectively make in the R&D pipeline. Okay, great.

Ovarian cancer.

Certainly thank you.

Thank you Greg for your call.

Quite a difficult disease.

The ovarian cancer in general as the cheap.

Uh huh.

The.

The cancer or.

Cause of cancer in patients on my warm on the U S and sort of run 24000 diagnosed each year. So this is.

Unknown Executive: And Ellie, maybe you can pick up the question about ovarian cancer. Certainly, thank you. Thank you, Greg, for your call. A quite a difficult disease, you know; ovarian cancer, in general, is the chief cause or cancer in patients.

Around double of the GBM.

Patient population.

The majority of these patients are are diagnose in what we call the advanced stages of their already metastatic unusually when their metastatic of the first places around the ovaries into the abdomen. So they have what we call.

Unknown Executive: I'm a woman in the US, and it's around 24,000 or so diagnosed each year. So this is, you know, around double the GBM patient population. The majority of these patients are diagnosed in what we call the advanced stage. So they're already metastatic. And usually, when they're metastatic, the first place is around the ovaries into the abdomen. So they have what we call peritoneal disease.

Pairing tonio.

The fees so our therapy on the on the <unk>.

Of course on the abdomen is sort of like a almost like a targeted therapy for these type of disease in general.

The therapies available for ovarian cancer are all based on platinum based chemotherapy.

Unknown Executive: So our therapy on the torso and the abdomen is sort of like a, almost like a targeted therapy for this type of disease. In general, you know, the therapies available for ovarian cancer are all based on platinum-based chemotherapy. And in general, most of these patients will fail platinum-based chemotherapy. And then there, their prognosis is very poor.

In general most of these patients were failed platinum.

The chemotherapy and then the.

The.

The problem of notes is very poor right. So the treatment options are very limited and the this is why we think that.

Unknown Executive: So, the treatment options are very limited, and this is where we think that Innovate makes a big, big difference. Our previous data was very promising, and that's what we're moving to phase three. Our phase two pilot study showed quite an improvement in our PFS.

It makes a big big difference, we our previous.

Data.

It was very promising and that's where we're moving to into <unk> into a phase III.

As to.

I look study show a quite improvement in Delaware.

Unknown Executive: So, we hope that in this phase three trial, we'll show the same or even better PFS and overall survival. Just to make a point and show how, in spite of the COVID times, we have been able to increase the enrollment. There's a lot of motivation in the field for the investigators. We have involved the two largest oncology or gynecological oncology groups in the world. One is the NCUB in Europe and the GOG Foundation in the U.S. And in spite of not being able to open the U.S. sites last year because of COVID, once we did this, we have been very, we're really encouraged by the enthusiasm of this investigative community.

PFS. So we hope that we are in.

In this phase III.

Trial will show.

The same or even better.

PFS and overall survival.

To make a point and how in spite of the Covid times, who have been able to increase the enrollment. It is a lot of motivation in the field on the page on the.

Investigators we have involved the two largest on.

Ecology or clinical logic on the.

Oncology groups in the World one is the <unk> in Europe, and Doj Foundation in the U S M.

And in spite of having the <unk>.

Being able to open the U S sites because of Covid once we last year when we wanted once once we did this.

The very well.

We're really encouraged by the enthusiasm.

From the investigator community. So I think we're all set up for success.

Unknown Executive: So, I think we're all set up for success. We're just, you know, executing this trial faster than we have planned, and we hope to have the last patient in at some point in the Q3 of this year. Thanks, Billy.

Just.

<unk> executed on this.

Trial faster.

The plan and we hope to have the last patient in.

Some point.

Q3 of this year.

Thanks Kelly.

Unknown Executive: Uri, I'm just going to ask Uri if you have any additional comments on the early science and the preclinical or phase 2 data to add. Absolutely, I think that our earlier preclinical data in ovarian cancer is very compelling, and we have actually tested TT fields in multiple different diseases, in multiple different malignancies, demonstrating the synergistic effect of TT fields when combined with different taxames. Being an agent that targets the mitotic spindle, similar to TT fields, this really has the potential to augment the overall effect in ovarian cancer, in particular, and due to the multiple chemotherapeutic options which are extremely toxic and with similar performance in the disease, the addition of TT fields at different phases of the disease in this patient population has really great potential to improve the outcome overall.

But I'm just going to ask worry if you have any.

Any additional comments on the on the.

Earth Science and.

Okay.

Preclinical or phase II data to add.

Absolutely I think thats our.

The earlier preclinical data in ovarian cancer is very compelling and we.

We have actually tested I think he feels the multiple different diseases and entrepreneur different malignancies, demonstrating the synergistic effect of the defense when combined with them.

Instead of Taxane and being an agent that targets the Adam I don't expand the similar to the TT fields.

And the <unk> has the potential to augment the overall affecting the ovarian cancer in particular due to the multiple.

Chemotherapy otic options, which are extremely tough second half.

We've seen in our performance in the disease and the addition of <unk> of different phases of the disease. In this patient population is really a great potential to improved outcome overall.

Uri Weinberg: Okay, thanks Uri. And Greg, maybe to your third question. We are, as I said in my earlier comment, extremely fortunate in the organic potential of our platform therapy. You know, most medtech companies have hundreds, thousands, even 10,000 small products, and they have to acquire, you know, they have to constantly survey the small company landscape in order to hopefully bring in companies at good prices and add them to this terrific bundle. We don't need to do that.

Okay, Thanks, Lori and Greg maybe to your third question.

We are as I said in my earlier comment extremely fortunate in the organic potential of our platform therapy.

Most.

The med tech companies.

The <unk>.

Hundreds of thousands even 10000 small products.

And then they have to acquire they have to be constantly surveying the the small company landscape in order to hopefully bring in companies at the.

At good prices and add them to the terrific bundle, we don't need to do that we have a huge tam in oncology in front of us and most biotech companies have to go back to the bench you know even the successful ones.

William F. Doyle: We have a huge TAM in oncology in front of us, and most biotech companies have to go back to the bench, have fantastic drugs, but then they have to go back to the same high-risk discovery enterprise in order to get the next. We're taking the same mechanism of action. The same science and the same technology are applied to different cancers, all of which are much larger than our GBM opportunity.

I have.

Fantastic drugs, but then they have to go back to the same high risk discovery enterprise in order to get the next one.

We are taking the same mechanism of action.

The same.

Science, and the same technology and applying it to different cancers.

Cancers, all of which are much larger than our GBM opportunity. So thats, a long way of saying why our priorities are so heavily focused.

William F. Doyle: So that's a long way of saying why our priorities are so heavily focused on oncology. Our scientists, of course, are studying all sorts of different things, but our focus is undoubtedly on oncology simply because the opportunity is so large. Thank you. Thank you. Our next question comes from Larry Biegelsen with Wells Fargo. Your line is open.

In oncology.

Our scientists of course are studying.

All sorts of of different things.

But our focus is.

Undoubtedly on oncology, just simply because of the opportunity is so large.

Thank you.

Thank you. Our next question comes from Larry Nicholson with Wells Fargo. Your line is open.

Good morning, Thanks for taking the question.

Lawrence H. Biegelsen: Good morning. Thanks for taking the question. First, for me, Ashley or Bill, how much do you think COVID will negatively impact your GBM business in 2020? What impact do you expect it to have in early 2021? And Ashley, any reaction to, you know, the consensus of $584 million on the top line?

First for me Ashley or Bill how much do you think on Covid.

Covid how much do you think it negatively impacted your GBM business in 2020, what impact do you expect it to have an early 2021 and actually any reaction to consensus of $5 84 million of on the top line and what are you guys assuming of about the Medicare of backlog revenue in 2021.

Ashley Cordova: And, you know, what are you guys assuming about the Medicare backlog revenue in 2021? We've seen that a couple quarters now. And I had one follow-up question. Ashley, I'll let you start, and then I'll follow up.

<unk> seen that a couple of quarters now.

And I had one follow up.

Actually I'll, let you start and then I'll follow up.

Ashley Cordova: All right, so maybe I'll start with the forward-looking view, and then I'll let Bill and Tash provide some more COVID color. But you know, as you know, everybody knows, we don't provide guidance. But what we have said consistently is that we do see room for incremental growth, both in terms of GVM penetration, particularly with the academic centers, and in the net revenues that we are able to book per active patient.

Alright, so maybe I'll start with the forward looking view and then all of that Dell and the cash provide some more COVID-19 color, but as everybody knows we don't provide guidance, but what we have said consistently is that we do see room for incremental growth. Both in terms of GBM penetration, particularly on the academic centers.

And on the net revenue that we are able to buck per app completion, so that will come from the remaining Medicare.

Ashley Cordova: So that will come from the remaining Medicare upside, you know, at we're currently booking approximately two-thirds of the upside from that LCD coverage in 2019, as well as the full year benefit from Israeli reimbursement after ramping up and the Switzerland reimbursement, which will come on in 2021. So I would point to those factors beyond just ongoing prescription growth and active patient growth coming from extended duration of therapy as contributing to our 2021 top line forecast.

Outside at we're currently booking approximately two turns of the upside from that LCD coverage in 2019 as well as the full year benefit from Israeli reimbursement post ramp up and the Switzerland reimbursement, which will come on line 2021.

Two of those factors beyond just ongoing prescription growth in active patient growth coming from extending the duration of therapy.

Contributing to our 2021 top line forecast.

Ashley Cordova: I'll pause there maybe and ask Tesh if you want to provide any, yeah, I'm seeing here backlog questions specific to the backlog. This is, you know, really impossible to predict, Larry, and so I would not recommend that you try to predict the contribution for these types of claims. You know, we are, of course, committed to receiving fair pay for all of the patients that we treated for Medicare and the backlog, and we will continue to work those claims through appeal.

I'll pause there may be enough cash if you wanted to provide any yeah I'm seeing your backlog question specific to the backlog this is new.

Really impossible to predict Larry and so I would not recommend you.

Try to predict the contribution from these type of claims we are of course committed to receiving therapy for all of the patients that we treated from Medicare in the backlog. When we will continue to work those claims through appeal, but if there is no kind of path that is predictable that I can point to forecasting revenue from it.

Ashley Cordova: But there is no kind of path that is predictable that I can point you to for forecasting revenue. Yeah, and let me start with COVID. And then I'm going to ask Pritesh to give you some specific color.

And let me start on Covid, and then I'm going to ask for cash to.

To give you some specific color.

William F. Doyle: We had, I won't say prescience, but we had early visibility as the pandemic unfolded. We're a global business. We have clinical trial sites in Italy. We have an active partnership in China. We have tentacles in the supply chain in China. And we're very global. So we made the transition to the virtual world, I think, very quickly.

We had.

I won't say impressions, but we had early visibility as the pandemic unfolded, we're a global business we.

We of clinical trial sites in Italy.

We have of active partnership in China.

We have.

The technicals on the supply chain in China.

And we're in we're very global so we.

The.

Transition to the virtual World I think very quickly.

William F. Doyle: And Assaf, from the beginning, as the pandemic unfolded around the world, made it absolutely clear to everyone in the management team that COVID would not be an excuse for any, for any, failure to treat our patients and accomplish our mission. That said, you know, and we delivered a fantastic year and a fantastic Q4. That said, it has not made our lives any easier, but it's made the work in the clinical trials more

And the source from the beginning is endemic unfolded around the world.

Made it absolutely clear.

To everyone on the management team the Covid would not be an excuse for any.

On.

For for any.

Ah.

Failure to treat our patients and accomplish our mission.

That said it.

And we delivered a fantastic year and a fantastic Q.

Q4.

That said it has not made our lives easier it's.

It's made the.

The work in the clinical trials more.

William F. Doyle: It's made commercial work more difficult because much of what we do depends on education, and education, as anybody with kids sitting in the living room in front of an iPad knows, is better done face-to-face than over Zoom, although Zoom is possible.

More difficult it's made the commercial work more difficult.

Cause much of what we do depends on the education and education as anybody with kids sitting in the living room in front of an iPad notes.

Is better performed face to face the.

Then over zoom, although zoom as possible.

William F. Doyle: So, I'm terrifically proud of what we have accomplished. We have not let COVID be an excuse. We've treated our patients, we've expanded our programs. But you know, with that, Pritesh, maybe you could talk a little bit about what you've had to overcome in the field in order to deliver these numbers. Sure, Bill, thank you.

So I'm terrifically.

The.

Proud of what we have accomplished.

We have not let COVID-19 be an excuse.

We've treated our patients we've expanded our programs.

But with that protest maybe you can talk a little bit about what you have had to overcome in the field in order to deliver these numbers.

Sure Bill Thank you and Larry. Thank you for the question. So this this is our bread and butter on the commercial side and what guides US and continues to guide US is our mission to help all eligible patients for GBM and NPM and I will Echo my pride here in how the entire Novocure team.

William F. Doyle: And Larry, thank you for the question. So this is our bread and butter on the commercial side. And what guides us and continues to guide us is our mission to help all eligible patients for GBM and MPM. And I will echo my pride here in how the entire Novocure team has flexed to ensure that what we are dealing with, that we're not immune to COVID, but we can appropriately pivot and make sure that no patient is left behind. And we proved in 2020 that we were able to successfully grow our business. Now, we are at the mercy of what happens at these academic centers.

<unk> has flexed to ensure that what we are dealing with and we're not immune to COVID-19, but we can appropriately pivot and make sure that no patient has left behind and we prove that in 2020 that we were able to successfully grow our business now we are at the mercy of what happens at these academic centers, we have seen over the.

Pritesh Shah: We've seen across the globe that patient flow will tend to fluctuate because of what may be happening within that specific region. So we monitor those regions closely. And what we are focused on in 2021 to continue driving our business is working with these academic centers in the U.S. and in Germany, where our footprint is the largest, to make sure that we continue on with the educational efforts, both with patients when we can with providers, and providing support to patients during these times where we may not be able to be in front of them. And on this front, virtualizing our patient support services, being able to meet with physicians and And now, what we're seeing is a glimmer of hope.

<unk> of 2020 across the globe that patient flow will tend to fluctuate because of what may be happening within that specific region. So we monitor those regions closely and what we're focused on in 2021 to continue drive our business is working with these academic centers in the U S in Germany, where our footprint is the <unk>.

Just to make sure that we continue on with the educational efforts both with patients when we can with providers and providing support to patients. During this times, where we may not be able to be in front of them and pivoting on this front virtualized, our patient support services being able to meet with <unk>.

<unk> and providers over zoom and now what we're seeing is a glimmer of hope in some areas. We're actually now able to meet with certain providers face to face. So we're mobilizing our teams in a safe manner to make sure that we can continue on the pathway and continue to support patient. So we remain optimistic we remain.

Pritesh Shah: In some areas, we're actually now able to meet with certain providers face-to-face. So we're mobilizing our teams in a safe manner to make sure that we can continue on the pathway and continue to support patients. So we remain optimistic. We remain confident. Our work with GBM and MPM does not stop because of COVID. And I'm confident the team will be able to deliver again in 2021.

Confident.

Our work with GBM in MTM does not stop because of Covid and I am confident the team will be able to to deliver again in 2021.

Thank you God I guess, if I could go ahead on Larry the only thing I just wanted to highlight of course here that we mentioned is that.

Pritesh Shah: Larry, the only thing I just wanted to highlight, of course, here that we mentioned is that we have opened Trident in the midst of the pandemic. There's tremendous interest in this trial. We continue to roll it out and expect to open it in 100 academic centers. And this was all done in the virtual world.

We have open trade ins.

In the midst the pandemic there is tremendous interest in this trial, we continue to roll it out.

And if you expect to open at the 100 academic centers and this was all done.

In the in the virtual world.

Pritesh Shah: All right, perfect. All right, I'll let others jump in. Thanks for taking the questions, guys. Thanks, Larry.

Alright perfect.

I'll, let others jump in thanks for taking the questions guys.

Thanks, Larry.

Okay.

Vijay Kumar: Our next question comes from Vijay Kumar with Epicor ISI. Your line is open. Hey guys, thanks for taking my question. I had a few questions back on Larry's question on the CMS backlog. I guess, can you at least quantify or comment on the payments that you've received so far? It looks like it was about $11 million-ish of catch-up payments in Q4.

Our next question comes from Vijay Kumar with Evercore ISI. Your line is open.

Hey, guys. Thanks for taking my question I had a few questions back on the Larry's question on the CMS backlog.

Yes.

Can you at least.

Quantify or.

Comment on on the.

On the payments that you've received so far it looks like it was about $11 million issue of catch up payments in Q4.

Ashley Cordova: When were these patients treated, right? So the payment that we've collected, was this for patients treated in a 17-18 timeframe? Any color would be helpful.

When would these patients treated right. So the payments that we have collected was this with patients treated in 17 18 timeframe any color would be helpful.

Ashley Cordova: Yeah, certainly BJ. So these patients were all treated prior to the LCD in September 2019. So there's a sampling there, but you are correct that they are dated multiple years older, right? So that 11 million all relates to patients treated prior to September 2019. Gotcha. And then, I guess, script volumes at a high level, Ashley. It's been around the mid-singles.

Yes, certainly the J. So these patients were all treated prior to the LCD in September of 2019 centers. The sampling there, but you are correct that they are data in multiple years aged.

So these are all of that $11 million all relates to patients treated prior to September 2019.

Gotcha and then.

And then.

Guess strip volumes sort of high level actually it's been around the mid singles I mean last year was.

Ashley Cordova: I mean, last year was, I guess, with the pandemic, it's really hard, you know, to figure out trends. Any comments on, you know, what should script volume growth be for you guys? I know you had the record versus new GBM dynamic that Chef perhaps hampered. Is there a sense of what underlying script volume growth should be for the business in GBM? Yeah, I'll let Tesh provide the color

With the pandemic, it's really hard.

Configure out trends.

Any comments on.

What should the trip volumes go to the.

Are you guys I know you had.

On the record and versus new GBM dynamic the shift perhaps Stanford is there a sense on what underlying script volume growth should be for the business in GBM.

Yeah, I'll, let cash provide the color here I mean, our message are lumpy of clear is that we do believe there's multiple levers, which remains the drive growth and cash maybe you can provide.

Pritesh Shah: I mean, our message, which I will keep clear, is that we do believe there are multiple levers which remain to drive growth, and Tesh, maybe you can provide some context as to what we're doing there. Yes, absolutely. So again, thank you for the question again, and I will emphasize what we talked about a bit earlier in terms of our educational efforts and engagement with the key academic centers. And on this front, I will take a moment to also talk about how we engage with academic centers on the clinical front, because that's also important to think about how we build additional data in GBM to provide greater support.

Some context as to what we're doing now.

Yes, absolutely. So thank you for the question again, and I will emphasize what we talked about a bit earlier in terms of our educational efforts and engagement with the key academic centers and on this front I will take a moment to also talk about how we engage with the academic centers on the clinical front.

That's also important to think about how we build additional data in DB GBM provide greater support and our investigators sponsored studies are of great opportunity for key academic centers to participate in generating additional signals and making sure that they are thinking about how to incur.

Pritesh Shah: And our investigator-sponsored studies are a great opportunity for key academic centers to participate in generating additional signals and making sure that they are thinking about how to incorporate TT fields, opt-in specifically in GBM moving forward. And one specific example here, if you participated in our R&D day, was the to-the-top IST by one of our key investigators.

Corporate TT fields opportune, specifically in GBM moving forward and one specific example here is if you participated in our R&D day was the two of the top ISP by one of our key investigators and here, we're learning about how another therapy. So immunotherapies are being.

Pritesh Shah: And here we're learning about how another therapy, so immunotherapies, are being explored in GBM. And we have preclinical data here to suggest that TT fields can have an impact here in helping the immune system create a greater response. And adding here Pembrolizumab again shows that this could be a potential benefit through this IST. The reason why I flagged this is that as our product gets further and further entrenched in clinical practice, these types of questions are going to come up.

Explored in GBM and we have preclinical data here to suggest the TT fields can have an impact here and helping the immune system create a greater response here and adding here with timber loser Mab again shows that this could be of potential benefit through this ISP. The reason why I flagged as is.

As our product gets further and further entrenched in clinical practice. These types of questions are going to come up can I combined with the latest therapy does your and here, we're showing that we can do that successfully and we're trying it in a smaller study here of course is not commercially available yet but this.

Pritesh Shah: Can I combine it with the latest therapy du jour? And here we're showing that we can do that successfully. And we're trying it in a smaller study here. This, of course, is not commercially available yet, but this experience gives physicians confidence when they're in the clinic. When they're evaluating a patient who is eligible for opt-in as prescribed today, it gives them greater confidence to continue building on the penetrations that you heard Asaf talk about, anywhere from 30 to 40%.

Experience gives physicians confidence when they are in clinic, when they're evaluating of patient who is eligible for opportune as prescribed today. It gives them greater confidence to continue building on the penetrations that you heard of soft talk about anywhere from 30% to 40%. We believe based on our existing data today based.

Pritesh Shah: We believe, based on our existing data today, based on the guideline recommendation, NCCN Category 1, and some of the other guidelines across the globe, that we have a continued opportunity to provide support to clinicians and to all the patients facing GBM, and also now building up in the NPM space.

On the guideline recommendation the NCC on category one on some of the other guidelines across the globe that we have continued opportunity to provide support to the clinicians and to all of the patient facing GBM and also now building up in the NPM space. So.

Pritesh Shah: So, what we do commercially today in front of education, in terms of working with these key academic centers, will have a significant impact on our path forward, which we've spent a lot of time on this call talking about. So, we're sort of doing the work today to grow our business today, but also to bridge the future whenever we can. Just on that last point, Rakesh, mesothelioma, you know, what's the trend in adoption?

What we do commercially today in front of the education in terms of working with these key academic centers will have a significant impact on our path forward, which we've spent a lot of a lot of time on this call talking about so we're sort of doing the work today to grow our business today, but also to bridge to the future whenever we can.

And just on that last point Rockies method.

Mesothelioma.

What's been the trend in the adoption.

Pritesh Shah: You know, did we see any new prescriptions coming in from mesothelioma in Q4? Yeah, so again, thank you for that question. So mesothelioma, it continues to be an important business for us, because first of all, we're helping patients with another rare disease type, and this very squarely fits into our mission. We received 17 prescriptions for OptumLua.

Did we see any script.

The strip.

New prescriptions coming in from mesothelioma in Q4.

Yes. So again, thank you for that question. So mesothelioma as it continues to be an important business for us because first of all we're helping patients with another rare disease type and in this very squarely fits into our mission. We received 17 prescriptions for opt in lieu of and at the end of quarter. Four we had 16 active patients.

Pritesh Shah: And at the end of quarter four, we had 16 active patients. If you go back to sort of where we started our journey with glioblastoma, recurrent glioblastoma, much of the work we had to do there was to educate the physicians, educate the patients, and insert ourselves into the treatment algorithm. And that's the work that we're doing here. And we'll continue to support the mesothelioma franchise because it helps pave the path for us for what's to come in the future. That's helpful. And maybe Bill, one for your apologies for the numerous questions.

If you go back to sort of where we started our journey with glioblastoma recurrent glioblastoma much of the work we have to do there to educate the physicians educate the patients insert ourselves into the treatment algorithm and thats. The work that we're doing here and we will continue to support the mesothelioma franchise because of it.

It helps pave the path for us and what's to come in the future.

That's helpful and maybe one for you apologies from Rod of the numerous questions, but I saw some language around the ntis.

William F. Doyle: But I saw some language around NCIT in the care. Can that, I guess, is that a positive for your business, Bill? So, with respect to the MCIT impact, we do not expect an imminent material impact on our business. We're going to evaluate all the possibilities to leverage the MCIT rule for any future indications where the necessary criteria are met. You know, in general, we think this is a positive rule and a positive ruling for the med tech industry. But it's too early for us to figure out exactly how.

On the cure.

Can that I guess is that of positive for your business Bill.

So.

With respect to the <unk> impact, we do not expect an imminent material impact to our business.

To evaluate all of the possibilities to leverage the M City rule.

For any future indications where necessary criteria are met.

In General we think this is a positive rule of positive ruling for the for the Med Tech industry.

But it's too early for us to figure out exactly how it will affect us.

William F. Doyle: Okay. Thanks, guys. Thank you. Our next question comes from Desai Yang with Mizuho Security. She agrees with you.

Understood. Thanks, guys.

Thank you. Our next question comes from Duffy Yang with Mizuho Securities. Your line is open.

Dan Clark: Hi, thank you. This is Dan Clark on behalf of DCEI. Could you just provide some more color on what drove the increase in active patients in Europe in the quarter? Sure. Good morning, Dan.

Hi. Thank you this is Dan Clark on for <unk> could.

Could you just provide some more color on what drove the increase in active patients in Europe in the quarter.

Sure. Good morning, Dan protests, maybe you can talk about Europe.

Pritesh Shah: Pritesh, maybe you can talk about Europe? Yes. Thank you for the question and the interest in our European market. So again, what drives our activation is demand and our ability to expand our business in Europe. So we have markets like Sweden, Israel, which are also part of our EMEA operations, and Germany being the sort of greatest footprint that we've built. So Austria, Germany, Sweden, and Israel are key markets.

Yes. Thank you for the question on the interest in our European market. So again, what drives our active patient is demand and our ability to expand our business in Europe. So we have markets like Sweden, the Israel, which also is part of our EMEA operations in Germany being the the.

Sort of greatest footprint that we build so Austria, Germany, Sweden, Israel, our key markets and here all the things that we've been talking about in terms of educating the the.

Pritesh Shah: And here, all the things that we've been talking about in terms of educating prescribers, some of the reimbursement decisions, the expanded reimbursement, which gives providers greater confidence, those are the things that drive our activations. Yeah, that's where I would end my response there.

The prescribers some of the reimbursement decisions the expanded reimbursement, which gives providers greater confidence those are the things that drive our active patients and.

Yes, that's where I would I would end my response there.

William F. Doyle: Yeah, and I just want to underline that 2020 was a big year for reimbursement decisions in EMEA, with Germany, Israel, and Switzerland all making positive reimbursement decisions. That's real momentum, and it's clearly the momentum that we are now leveraging into France as we set the stage for expanding our French program. Thank you, that's helpful.

Yeah, and I would just underline that.

2020 was the big year for.

Reimbursement decisions and in.

EMEA with.

Germany, Israel and Switzerland.

Paul.

Making positive reimbursement decisions, that's real momentum in and it's clearly that's the momentum that we are.

Now leveraging into France.

As we as we set the stage for our.

Expanding our French business.

Okay. Thank you that's helpful. And then just as a follow up how should we think about R&D spend going forward, Mike <unk> as a percentage of revenue and is this sort of on the right way to think about that expense line.

Ashley Cordova: And then, just as a follow-up, how should we think about R&D spend going forward, like as a percentage of revenue, and is this sort of the right way to think about that expense? So I'm going to let Ashley talk about the fence line, but let me just say, and I'm going to go back to a theme, I hate to say harp on a theme, but we have this tremendous opportunity, this tremendous organic opportunity that includes expanding into new indications and with tremendous TAM.

So I'm going to let him talk about the expense line, but let me just say I'm going to go back to a theme I get to say harp on a theme but.

We have this tremendous opportunity the tremendous organic opportunity that includes expanding into new indications.

And with tremendous Tam.

Ashley Cordova: And one thing we haven't talked about much on this call, but we have talked about on previous calls, really improving from what is already the best in category efficacy; we think that we can dramatically improve that through product development. And that product development, of course, fuels what we described in the prepared remarks as a virtuous cycle of innovation, growth, innovation, growth, innovation, growth. And so we really are; we view our R&D investment as a badge of honor here. And Ashley can now describe that badge of honor.

And one thing we haven't talked about much on this call, but we have talked about on previous calls really.

Improving from what already is best in category efficacy.

That we can dramatically improve that.

Through product development and that product development of course fuels. What we described in the in the prepared remarks. This virtuous cycle of innovation growth innovation growth innovation growth.

And and so we really are we view, our R&D investment as a badge of honor.

Here in Ashley can now described the badge of honor.

William F. Doyle: Yeah, I'll try to be efficient here given the time. But I would say, Dan, don't yet think of it as a percentage of net revenue. We are looking to invest everywhere where we can make effective and appropriate investments.

Yeah.

Try to be efficient and sort of given the time, but I would say Dan don't yet think of it as a percentage of net revenue. We are looking to invest everywhere, where we can make it back taken the appropriate investments you heard of some detail on the call that that spans multiple functions within R&D clinical development to advance our phase III pipeline medical affairs to engage the clinical community.

Ashley Cordova: You heard in detail on the call that that spans multiple functions within R&D, clinical development to advance the RK3 pipeline, medical affairs to engage the clinical community, as well as basic research and product innovation. I would say, you know, five, 10 years out, I would think about this as a percentage of net revenue. But in the near term, I would say we are investing as aggressively as we can in every opportunity we have to unlock future value. Okay. Thank you. Bye-bye.

As long as the basically search on the product innovation I would say.

510 years out I would think about this is the first one that you haven't had any of that in the near term I would say we are investing on.

As aggressively as we can and every opportunity we have to unlock future value.

Okay. Thank you I'll pass the line.

Ashley Cordova: Thank you. Our next question comes from court. Corey, are you on the line?

Thank you. Our next question comes from corn.

Okay.

Okay.

Corey when you're on the line.

Corey: Hi, this is Gavin from PCORI. Thanks for taking our questions today and thanks for the update. We just had two on hepanova and liver cancer. Can you just talk about, you know, it seemed like this got pushed out slightly to Q2 versus Q1, and the original PR last summer kind of set the stage for like a January readout. So maybe you can discuss the dynamics going on there.

Hi, This is gavin on for Cory.

Thanks, Thanks for taking our questions today on thanks for the update where you saw two on top of another in liver cancer.

Can you just talk about it seemed like just got pushed out slightly to Q2 versus Q1 on the original.

The last summer.

Set the stage for the January readout. So maybe you can discuss on the dynamics going on there and then secondly, sticking with the Nova.

Uri Weinberg: And then secondly, sticking with hepanova, the study is designed to show 20% ORR type of serotonin. However, the treatment regimen has changed. So just curious your thoughts on the path forward there would be great. Thank you. Uri, do you want to take the question about Hapanova? Absolutely.

The study is designed to show 20% of.

Our top of Sorafenib.

The the treatment regimen. The has has changed so just curious your thoughts on the path forward there.

It would be great. Thank you.

Or do you want to take the question of what happened.

So looking so good morning, again on everybody and thank you for the question. So as everybody recalls that we have enrolled the last patient in.

Uri Weinberg: So, good morning again everybody, and thank you for all the questions. As everybody recalls, we enrolled the last patient in PANOVA, our phase two study in hepatocellular cancer incorporating T-D-FILs into systemic therapy with sorafenib in advanced unreceptable hepatocellular carcinoma patients.

<unk> all of on June <unk>.

But of as our phase two study in the bundle some of our costs are incorporating day defenses to the systemic therapy with Sorafenib in advanced Unresectable <unk> carcinoma patients. Currently we are working on finalizing the data collection on multiple centers in Europe.

Uri Weinberg: Currently, we are working on finalizing data collection at multiple centers in Europe. And anyone who has been involved in the operations of clinical studies knows how meticulous and careful this process is. It takes time to complete this in every trial.

Anyone who has been involved in the operations of clinical studies knows how meticulous on careful on these processes I think.

To complete this on every trial and given the COVID-19 situation in the countries, where we conducted on the <unk>.

Uri Weinberg: And given the COVID-19 situation in the countries where we conducted the study in Europe, it is taking even a bit longer, but our teams are doing an outstanding job completing it. And despite that slight delay, we expect to have visibility into the data in Q2 of 2021. We plan to present the results at an upcoming medical congress once the final results are available. So this is in terms of the HEPA-NOVA study timeline and plans.

That is the study in Europe, it is taking even a bit longer and but our teams are doing an outstanding job completing the basically as we speak.

Despite.

Despite of that slight delay, we expect to have visibility into the data in Q2 of 'twenty 'twenty, one and we plan to present the results have been upcoming medical Congress. Once the final results are available. So this is in terms of the ethanol the study timeline of implants.

Uri Weinberg: Now, regarding the other question concerning changes in standard of care, I believe that we have already demonstrated that TT-Fields is a platform therapy, which on one hand exerts its own antimyotic effects and, on the other hand, has the potential to increase effects in other treatments too.

Regarding the other question concerning them.

Changes in standard of care.

So I believe that we have already demonstrate that the PTC has as the platform therapy shell on one hand.

Exerts its own antimitotic effects and on the other hand as the potential to increase the effects.

Other therapies that too so the platform that we have which allows us to combine TT fields as the low toxicity therapy with other.

Uri Weinberg: So that platform that we have, which allows us to combine TT-Fields as a low toxicity therapy with other existing therapies, is very relevant in the context of hepatocellular cancer as well. And we always take into account changes in the standard of care for malignancies that we are targeting through our clinical program. And specifically in hepatocellular cancer, we have seen changes that involve immunotherapies, such as epizoolizumab, in the treatment of such patients. We are particularly excited about the potential of TT-Fields in this malignancy, given the concomitant effects that we see when TT-Fields is combined with immune checkpoint inhibitors, as demonstrated preclinically.

Existing therapies.

Very relevant in the context of deposits on our cancer M.

And we always take into account changes from the standard of care of malignancies that we are targeting through our clinical program.

And specifically in the photo set.

Of our cancer, we have seen changes.

Involve the immunotherapies that because of the lethal model of being the treatment of such patients. We are particularly excited about the potential of sales DTC has been this malignancy and <unk>.

Given.

The concomitant the fact that we see when DTC is our combined with the immune checkpoint inhibitors as demonstrated pre clinically and as you'll recall. We also go in this direction in non small cell lung cancer and through our collaboration with them as Dean in the.

Uri Weinberg: And as you recall, we also go in this direction in non-small cell lung cancer through our collaboration with MSD in the upcoming keynote study. So I believe that TT-Fields is positioned in a very good place, considering the existing EPINOVA study results, which are coming, but also looking forward to the future and changes, potential changes in the standard of care in the field. Great, thank you.

And the upcoming keynote the study so I believe the STB field of disposing of a very good place considering the existing upon all of the study results, which are upcoming but also looking forward into the future and changes potential changes need to start of carry in the field.

Great. Thank you.

Uri Weinberg: Thank you. Our next question comes from Jason Witts with Northland Securities. Your line is open.

Yes.

Thank you. Our next question comes from Jason Wittes with Northland Securities. Your line is open.

Hi, Thanks, Thanks for the questions.

Jason Witts: Hi, thanks. Thanks for the questions. Just on the timelines, some changes, some slippage, it sounds like most of that is COVID-related. But I think you've also discussed in the past how, I don't know if the policy has changed, but you're looking to start presenting some of this data at scientific meetings as opposed to press releases. Can you clarify some of that in terms of these timelines?

Just on the the timelines some changes some slippage it sounds like most of that is COVID-19 related.

But I think you've also discussed in the past how.

I don't know the policy has changed but you are looking to.

The start presenting some of this data at scientific meetings as opposed to press releases can you.

Clarify some of that in terms of the.

William F. Doyle: Yeah, so I think in this call, you know, we have not changed the timelines for our primary phase three trials. We have seen our gastric cancer phase two, I'll use the word slip, but that trial was open in one center in Hong Kong. And we've just now started opening centers in mainland China that do not have anything to do with COVID. It just took a little bit longer to get regulatory approval in China.

Of these timelines.

Yes, so I think in this call.

We have not changed the.

On the timelines for our <unk>.

Primary phase III trials.

We have seen our gastric cancer.

The phase two.

I'll use the word slipped but that trial was opened in one center in Hong Kong.

We've just now.

The started opening centers in mainland China that did take of that had nothing to do with Covid. It just took a little bit longer day okay.

Jordan.

In the in China.

With respect to.

William F. Doyle: With respect to how we deliver the data, you know, we first have to get the data, and then we have to look at the data. Our goal is always to make sure that we don't do anything to jeopardize the Presentation and Publication of the Data in Appropriate Scientific Fora. At each juncture, we look at the appropriateness of releasing any top-line material results to the press, and that we do sort of one by one.

How we are.

The deliver the data.

First we have to get the data and then we have to.

After the look at the data our goal is always to make sure that.

We don't do anything to jeopardize the.

The presentation and publication of the data in scientific appropriate scientific fora.

And at each juncture, we look at the.

On the appropriateness of press, releasing any top line material results and that we do sort of one by one but again, we don't want of and this is the same of any biotech company. This is not.

William F. Doyle: But again, we don't want to... And this is the same with any biotech company. Specific to Novocure, nobody wants to jeopardize the publication or the presentation of the data on the site. Understandable. And that's a fair point. I think Panova 3 was originally, at least the last release I saw was 2021.

Specific to Novocure nobody wants to jeopardize the.

The publication or the presentation of the data in the scientific community.

Understood.

Fair point.

<unk> three was originally at least the last release I saw was 2021 of note I think it is the interim look is now of 2022.

William F. Doyle: And now the, I think it's the interim look, is now 2022. Is that a change? Or did I misread that? Well, that's the interim look.

Is that of change or did I misread that.

Well, that's the interim look.

Okay on which.

William F. Doyle: In enrollment driven, we do think that's going to have the potential to at least push over, but we're not changing the timing for final data. Understand? Okay.

Enrollment driven we do think thats going on.

William F. Doyle: And also, I believe you mentioned in some of the developed markets, you're kind of for GBM, you're somewhere in the 30 to 40% range. Is that a good way to think about the technology that stands now when you're pulling a reverse, you're kind of in that 30-40% range, or should we assume that? Will continue to increase so, my view, and I think it's shared by everyone on the team, and Pritesh said this, is that we can benefit.

William F. Doyle: So, for instance, in the US, we're about 40% penetrated. The other 60% can absolutely benefit from the therapy. So this is not a case where there are some specific patient characteristics that make it only applicable to 40%. Getting that other 60% really involves this engagement at academic centers and bringing investigators, and prescribers who are not currently confident to prescribe the therapy into the fold. This is what we do in our day-to-day engagement activities. It's also the reason that we do things like the Trident trial.

Of the therapy.

Into the fold.

This is what we're doing in our day to day.

The engagement activities. It's also the reason that we're doing things like the Triton trial.

William F. Doyle: We started our EF31 trial with high-intensity arrays and GBM last year. So everything that we're doing in the short term plus everything that we're doing in the medium term is all geared to driving those penetrations much higher than they are today. Great, thank you very much.

We started.

The F 31 trial with high intensity of raise in GBM.

Last year.

So everything that we're doing in the in the short term plus everything that we're doing in the medium term is all geared to driving the those penetration is much higher than they are today.

Thank you very much.

William F. Doyle: Thank you, and I'm currently showing no further questions. I'd like to turn the call back over to Bill Doyle for closing remarks. All right, so thank you everyone on the call for your interest in Novocure. Since we were founded by Professor Palti 20 years ago, we've been dedicated to advancing the science and technology of tumor treating fields and bringing the platform to treat patients with these very, very difficult cancers. That has led to our three overarching priorities.

Thank you and Im kind of Im showing no further questions I would like to turn the call back over to Bill Doyle for closing remarks.

Alright so.

Thank you everyone on the call for your interest in Novocure.

Since we were founded by Professor Palti 20 years ago, we've been dedicated to.

Advancing the science and technology of tumor treating fields.

And bringing the platform to treat patients with these very very difficult cancers.

That's led to our three overarching priorities one two to drive commercial adoption around the world and our approved indications.

William F. Doyle: One, to drive commercial adoption around the world in our approved indications. Two, to drive our clinical trial program to expand our indications and bring this therapy to patients with additional cancers. And then, as I just mentioned, to engage in product development to further improve the therapy, which is a tremendous opportunity for us to help patients and to build our intellectual property portfolio. 2020 was a great year, notwithstanding COVID.

Two to drive our clinical trial program to expand our indications and bring this therapy to patients with additional cancers and then as I just mentioned.

To engage in product development.

To further improve the therapy, which is of tremendous opportunity for us to help patients and to build our intellectual property portfolio.

2020 was of great year, notwithstanding COVID-19.

William F. Doyle: We grew 41%. We built tremendous financial strength through various balance sheet transactions. And we began the process of positioning our organization for significant expansion over the next few years as we anticipate these, including in our opportunity to help patients grow. So I wanna echo the words of my colleagues to thank everyone within Novocure. It's been a tremendous accomplishment under an unprecedented set of challenges.

We.

Grew 41%.

We built tremendous financial strength.

Through various balance sheet transactions.

And we began the process of positioning our organization for significant expansion over the next few years as we anticipate.

Including in our our opportunity to help patients expanding so I want to echo the words of my colleagues to thank everyone within Novocure.

It's been a tremendous accomplishment under an unprecedented set of challenges.

Operator: And, as I said, I wanna thank everybody on the call. See you next time. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect. Thank you for watching!

And as I said I want to thank everybody on the call for your interest.

<unk>.

Next time.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

[music].