Q1 2021 Novocure Ltd Earnings Call

Good day, and thank you for standing back and welcome to the Novocure first of quarter 2021, and these conference at this time all participants are in a listen only mode and I think of speaker's presentation. There will be a question and answer session to ask the question. During the session you will need to press star one on your cash.

Operator: Good day, and thank you for standing by. Welcome to the Novocure First Quarter 2021 in-use conference.

Operator: At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during that session, you will need to press star one on your telephone. If you require any further assistance, please press star zero.

Awesome. If you require any further assistance. Please press star zero and I would now like to hand, the conference over to your speaker today and everything.

And everyone and thank you for joining us to review Novocure has towards the first quarter of 2021 performance.

Adam Dainey: Good morning everyone, and thank you for joining us to review Novocure's first quarter.

Adam Dainey: first quarter 2021 performance.

Adam Dainey: I'm 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.

Im joined on the phone by our executive Chairman Bill Doyle, our CEO of <unk> and our CFO of 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 and Novocure dot com by clicking on the links of the first quarter of 2021 financial results located in the events section of our Investor Relations page.

Adam Dainey: The slides presented today can be viewed on our website, www.novocure.org.

Adam Dainey: by clicking on the link to the first quarter 2021 financial results.

Adam Dainey: Located in the events section of our investor relations page.

Before we start I would like to remind you that our discussion. During this conference call will include forward looking statements and actual results could differ materially from those projected and these statements.

Adam Dainey: Before we start, I would like to remind you that our discussion 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.

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 and our SEC filings, we do not intend to update publicly any forward looking statement, except as required by law.

Adam Dainey: Some of these are beyond our control, including those risks and uncertainties described from time to time in our ICC filings.

Adam Dainey: We do not intend to update publicly any forward-looking statement except as required by law. Following our prepared remarks today.

Following our prepared remarks today, we will open the lines of questions financials for the three months ended March 31, 2021 are available in our press release and in our 10-Q, both of which we released earlier this morning.

Adam Dainey: And with that, we will open the line for questions. Financials for the three months ended March 31, 2021 are available in our press office.

Adam Dainey: www.youtube.com Where appropriate, we will refer to non-GAAP financial measures to evaluate

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

Adam Dainey: Reconciliations of Non-GAAP Financial Measures to GAAP Financial Measures are

The reconciliations of non-GAAP financial measures to GAAP financial measures are also included in our press release and the appendix of the supplemental slides accompanying this presentation and on our form 8-K filed with the SEC. Today. These materials can be accessed from our Investor Relations page of our website www Novocure dot com with that I will now.

Adam Dainey: Also included in our press release in the appendix are the supplemental slides accompanying

Adam Dainey: presentation and on our form 8k filed with the SEC today. These materials can be accessed from our

Adam Dainey: from our investor relations page of our website, www.novacure.com. With that,

William F. Doyle: With that, I will now turn the call over to Bill Doyle. Thank you, Adam, and good morning, everyone. We are pleased to share our first quarter results today. Over the last several months, we have made progress across our clinical development programs to determine the optimal tumor-treating fields. Our established commercial business continues to generate the financial strength needed to invest in our future. As we look ahead, we believe multiple levers remain to unlock the full potential of the tumor treating fields platform. Our commercial business generated $135 million in net revenue in the first quarter of 2021.

And the call over to build the oil.

Thank you Adam and good morning, everyone. We are pleased to share our first quarter results today.

Over the last several months, we've made progress across our clinical development programs. The determined tumor treating fields optimal use of our established commercial business continued to generate the financial strength needed to invest and our future and.

As we look ahead, we believe multiple levers remain to unlock the full potential of the tumor treating fields platform.

Our commercial business generated a $135 million and net revenue and the first quarter of 2021 and.

And we invested $46 million and research and development programs intended to fuel future growth. We recently reached the exciting milestones and several clinical programs and continued to actively enroll patients and seven trials across six solid tumor cancers.

William F. Doyle: And we invested $46 million in research and development programs intended to fuel future growth. We recently reached exciting milestones in several clinical programs and continue to actively enroll patients in seven trials across six solid tumor cancers. Almost 20,000 patients have been treated with tumor treating fields. As we reflect on our progress to date and the road ahead, we believe we are just beginning.

Almost 20000 patients have been treated with tumor treating fields.

As we reflect on our progress to date and the road ahead. We believe we are just beginning.

Earlier this month, we announced that the pre specified interim analysis for our phase III pivotal lunar trial in non small cell lung cancer concluded with a favorable recommendation from the independent data monitoring committee or DMC to continue accrual successfully.

William F. Doyle: Earlier this month, we announced that the pre-specified interim analysis for our Phase 3 Pivotal Lunar Trial in non-small cell lung cancer concluded with a favorable recommendation from the Independent Data Monitoring, or DMC, to continue accrual. "Successfully Clearing the Futility Hurdle," There was no evidence of clinically relevant increased toxicity other than expected generally low-grade skin toxicity in the experimental arm. The DMC went on to say that continued accrual to 534 patients as proposed in the original protocol, given the current rate of accrual and the interim data presented, is likely unnecessary and possibly unethical for patients randomized to control.

Successfully clearing the futility hurdle.

There was no evidence of clinically relevant increase toxicity other than expected generally low grade skin toxicity and the experimental arm.

The DMC went on to say the continued accruals of 534 patients as proposed and the original protocol given the current rate of approval and the interim data presented.

The likely unnecessary and possibly unethical for patients randomized to control.

William F. Doyle: For this reason, the DMC recommended an adjustment of accrual to approximately 276 patients, with a 12-month follow-up following the enrollment of the last patient. The DMC believes this amended protocol would provide adequate data regarding toxicity and efficacy, providing sufficient overall power, as well as potentially providing important information regarding efficacy within the treatment subgroup. LUNAR is a multinational trial with sites in the United States, Western and Eastern Europe, and Israel, testing the safety and effectiveness of immune checkpoint inhibitors or docetaxel together with tumor treating fields versus immune checkpoint inhibitors or docetaxel alone for patients with stage 4 non-small cell lung cancer who progressed during or after platinum-based therapy.

And for this reason the DMC recommended and adjustment of the accrual to approximately 276 patients with a 12 months follow up following the enrollment of the last patient.

The DMC believes this amended protocol would provide adequate data regarding toxicity and efficacy providing sufficient overall power as well as potentially providing important information regarding efficacy within the treatment subgroups.

Lunar is the multinational trial with sites and the United States, Western and Eastern Europe, and Israel testing, the safety and effectiveness of immune checkpoint inhibitors or docetaxel together with tumor treating fields versus immune checkpoint inhibitors or docetaxel alone for patient.

And with stage four non small cell lung cancer, who progressed during or after platinum based therapy.

Advanced or metastatic non small cell lung cancer is commonly treated with platinum based therapy and the first line and the lunar trial was designed to generate data the contemplate multiple clinically meaningful outcomes for non small cell lung cancer patients following platinum failure.

William F. Doyle: Advanced or metastatic non-small cell lung cancer is commonly treated with platinum-based therapy in the first line, and the lunar trial was designed to generate data that contemplated multiple, Clinically Meaningful Outcomes for Non-Small Cell Lung Cancer Patients Following Platinum Failure. Though Novocure is fully blinded to the trial data and expects to remain blinded through completion of the trial, The DMC had full access to the trial data from both arms of the study when making their recommendation.

So novocure has fully blinded to the trial data and expect to remain blinded through completion of the trial the.

The DMC had full access to the trial data from both arms of the study when making the recommendations. We are very excited by the Dmc's recommendations and believe the potential to power all endpoints with the reduced sample size and follow up duration is an indication of the maturity of the trial data and strength.

William F. Doyle: We are very excited by the DMC's recommendation and believe the potential to power all endpoints with the reduced sample size and follow-up duration is an indication of the maturity of the trial data and strength of the single signal generated to date. We have submitted an IDE supplement to the FDA, which incorporates the recommended protocol adjustments, and are awaiting the agency's final determination following a 30-day review period. We are also engaging with our trial investigators to identify opportunities to accelerate enrollment. If approved, the new protocol could accelerate our trial completion by more than a year.

Of the single signal generated to date.

We have submitted and supplement to the FDA, which incorporates the recommended protocol adjustments and are awaiting the agency's final determination. Following a 30 day review period.

We are also engaging with our trial investigators to identify opportunities to accelerate enrollment.

If approved the new protocol could accelerate our trial completion and more than a year.

The DMC recommendation represents an important milestone and our lung cancer development program and and our efforts to better understand the potential benefits of tumor treating fields mechanism of action when used together with immunotherapies.

William F. Doyle: The DMC recommendation represents an important milestone in our lung cancer development program and in our efforts to better understand the potential benefits of tumor treating fields' mechanism of action when used together with immunotherapy. Preclinical research has shown that tumor-treating fields can induce immunogenic cell death. Multiple markers of cellular stress. Specifically, high mobility group B1 secretion and cal reticulant exposure increased significantly in the presence of tumor-treating fields. Cells treated with tumor-treating fields also exhibit autophagy-dependent reductions in adensine triphosphate levels. Our in vitro observations have been reproduced in animal models.

Preclinical research has shown the tumor treating fields can induce immunogenic cell death.

Multiple markers of cellular stress.

Specifically high mobility group of <unk> accretion and Cal ridiculous exposure increased significantly and the presence of tumor treating fields.

Sales treated with tumor treating fields also exhibit autophagy dependent reductions and adenosine triphosphate levels.

Our in vitro observations have been reproduced in animal models tumor treating fields together with anti PD, one therapy enhanced anti tumor immunity and resulted in increased tumor control in vivo.

William F. Doyle: Tumor treating fields together with anti-PD-1 therapy enhanced anti-tumor immunity and resulted in increased tumor control in vivo. We observed a significantly higher frequency of macrophages and dendritic cells in tumors in mice treated with tumor treating fields and anti-PD-1 therapy. Compared to tumors in mice treated with tumor-treating fields alone, anti-PD-1 therapy alone, and an untreated control mite, PD-L1 expression levels increased in tumors treated with tumor-treating fields, suggesting an elevated inflammatory response.

The observed of significantly higher frequency of macrophages, and dendritic cells and tumors in mice treated with tumor treating fields and anti PD, one therapies compared to tumors in mice treated with tumor treating fields of alone and.

The PD one therapy alone.

And an untreated control of mikes.

The PDL, one expression levels increased and tumors treated with tumor treating fields, suggesting and elevated inflammatory response.

We are eager to translate the preclinical experience the clinical data.

William F. Doyle: We are eager to translate this preclinical experience to clinical data. In addition to our Lunar trial, we recently received IDE approval to initiate our Phase 2 pilot Keynote B36 trial, conducted in collaboration with MSD, a trademark of Merck. Keynote B36 is designed to study tumor-treating fields together with Pembrolizumab in first-line, non-small-cell lung cancer. We believe data generated from the Lunar and Keynote B36 trials will provide valuable insight into the potential benefits of treating cancer with tumor-treating fields therapy concomitant with immunotherapy.

In addition to our lunar trial, we've recently received <unk>.

The approval to initiate our phase II pilot.

The 36 trial conducted in collaboration with MST of trademark of Merck.

Keynote <unk> <unk> 36 is designed the study tumor treating fields together with <unk> and first line non small cell lung cancer.

We believe data generated from the lunar and keynote <unk> six trials will provide valuable insight into the potential benefits of treating cancer with tumor treating fields therapy concomitant with immunotherapy.

William F. Doyle: Combination therapy is a cornerstone of cancer care, and we are developing tumor-treating fields as a limited toxicity backbone therapy upon which other standard of care and emerging cancer treatments can be added. In addition to immunotherapy, we continue to explore the potential benefits of using tumor treating fields together with radiation therapy and certain chemotherapies. We recently concluded our HEPA-NOVA trial investigating tumor-treating fields together with serapinib, a kinase inhibitor, in 25 patients with advanced liver cancer.

Combination therapy is the cornerstone of cancer care and we are developing tumor treating fields has a limited toxicity.

Bone therapy, upon which other standard of care and emerging cancer treatments can be added.

In addition to immunotherapy, we continue to explore the potential benefits of using tumor treating fields together with radiation therapy and certain chemotherapies.

We recently concluded our <unk> trial investigating tumor treating fields together with Sorafenib, a kinase inhibitor and 25 patients with advanced liver cancer. We have submitted an abstract for presentation at an upcoming medical conference in late June and look forward to discussing the full dataset with clinicians and best.

William F. Doyle: We have submitted an abstract or presentation at an upcoming medical conference in late June and look forward to discussing the full data set with clinicians, investigators, and investors in the future. I will now turn the call over to Asaf to discuss our commercial results for the quarter.

The Gators and investors in the future.

I will now turn the call over to SaaS to discuss our commercial results for the quarter.

Thank you Bill I will the team delivered another consistent quarter of execution in the first three months of 2021 global net revenues totaled $135 million with an 80% growth margin. This represents an increase of 32% in net revenues versus Q1 2020.

Asaf Danziger: Thank you, Bill. Our team delivered another consistent quarter of execution in the first three months of 2021. Global net revenues totaled $135 million, with an 80% growth margin. This represents an increase of 32% in net revenues versus Q1 2020. We ended the quarter with 3,454 active patients on therapy, an increase of 12% versus Q1 2020 and 1% versus 2020 year-end. This represents our 25th consecutive quarter of active patient growth. We are especially encouraged by the durability of our GBM business as we have seen disruptions in patterns of care due to the COVID-19 pandemic. We believe the challenges posed by the pandemic have caused some patients with increased health risks to delay in-person consultations with their healthcare provider.

We ended the quarter with 3454 active patients on therapy, and increase of 12% versus Q1, 2020 and 1% versus 2020 you and this represents our 25th consecutive quarter of active patient growth.

We are especially and colleagues by the durability of faux GBM business as we have seen disruptions and patterns of care due to the COVID-19 pandemic.

We believe the challenges posed by the pandemic of caused some patients with increased health risks to delay in person consultations glued the heska provide us.

And the aggressive cancers, we tweet this postponement can sometimes allow a patient's disease to progressed past the point of care.

Asaf Danziger: In the aggressive cancers we treat, this postponement can sometimes allow a patient's disease to progress past the point of care. Last month, we supported the launch of a nationwide campaign by S.V. Cancer in Germany, to raise awareness of the dangers of postponing care, together with Bristol-Myers Group. In the US, our ability to engage with healthcare providers in person has increased to begin the year. We are hopeful that the continued distribution of vaccines and subsequent normalization of activity between healthcare providers and patients will alleviate this factor going forward.

Last month, we supported the launch of a nationwide campaign by yes, we canso in Germany to raise awareness of the dangers of responding to together with the Bristol Myers Squibb.

And the U S. Our ability to engage with health care providers in person has increased to begin to you.

We are hopeful that the continued distribution of look scenes and subsequent and normalization of activity between healthcare providers and patients will alleviate this factor going forward.

We believe there are multiple opportunities to drive continued opportune adoption.

Last few we submitted the full reimbursement package to the French Ministry of health to establish reimbursement for <unk> and are awaiting guidance from the Ministry. In addition to France, we are continuing to evaluate opportunities to expand access and our approved indications in new markets.

Asaf Danziger: We believe there are multiple opportunities to drive continued Optune adoption. Last year, we submitted a full reimbursement package to the French Ministry of Health to establish reimbursement for Optune and are awaiting guidance from the Ministry. In addition to France, we are continuing to evaluate opportunities to expand access to our approved indications in new markets. Beyond the opportunity to expand our geographical presence, we are under-penetrated at several key academic centers in the U.S. and Germany, representing a significant opportunity to further increase opt-in adoption.

Beyond the opportunity to expand our geographical presence we are underpenetrated at several key academic centers in the U S and Germany, representing a significant opportunity to further increase opt and adoption as.

And as the lesson trains treatment modality compared to surgery radiation and chemotherapy and even immunotherapy opportune requires significant educational effort to drive awareness and increase confidence and belief in the therapy has the best chance for long term survival and newly diagnosed GBM. We are act.

The engaging with leading constant institutions to broaden the awareness of our therapy and further adoption.

Asaf Danziger: As a less entrenched treatment modality compared to surgery, radiation, chemotherapy, and even immunotherapy, it often requires significant educational effort to drive awareness and increase confidence and belief in the therapy as the best chance for long-term survival in newly diagnosed GBM. We are actively engaging with leading cancer institutions to broaden their awareness of our therapy and further adoption. We are also working to increase our clinical presence at leading academic centers and our engagement with key opinion leaders.

We are also working to increase our clinical presence at leading academic centers and our engagement with key opinion leaders.

In recent months researchers at Stanford University launched a study to determine the efficacy of TT fields. In addition to stereotactic radiosurgery for the treatment of GBM, we continue to onboard sites to our tried and trial evaluating <unk> concurred with what the Asian for the treatment of newly bags.

Asaf Danziger: In recent months, researchers at Stanford University launched a study to determine the efficacy of TT fields in addition to stereotactic radiosurgery for the treatment of GBM. We continue to recruit sites to our Trident trial evaluating TT fields concurred with radiation for the treatment of newly diagnosed GBM. We recently announced the steering committee for our keynote B36 trial, including representatives from MD Anderson, the University of Pennsylvania, the Miami Cancer Institute, and the Mayo Clinic.

And the GBM, we recently announced the steering committee for keynote B 36, Duane, including Representatives from MD Anderson, the University of Pennsylvania, The Miami Cancer Institute and the Mayo Clinic, we believe each of these engagements represent and opportunity to further increase of <unk>.

And with Ensign and believe NTT fields at leading institutions.

In light of the exciting news from our lunar trial I would like to take a moment to discuss our M. P. M business. The launch of M. P. M has provided the opportunity to engage with health care providers focus on cancer of the talks and build awareness of TT fields therapy. Among these specialty.

Asaf Danziger: We believe each of these engagements represents an opportunity to further increase confidence and belief in TT fields at leading institutions. In light of the exciting news from our Lunar Trial, I would like to take a moment to discuss our NPM business. The launch of NPM has provided the opportunity to engage with healthcare providers, focus on cancer of the thorax, and build awareness of TT Field Therapy among this specialty. While we do not expect NPM to materially contribute to net revenues in 2021, we believe the knowledge gained from this launch will prove quite valuable as we look ahead to potential launches in other Torso indications.

While we do not expect M. P M to materially contribute to net revenues in 2020. One we believe the knowledge gained from these loans will prove quite viable as we look ahead to potential launches in other Tulsa indications.

Time, and time again, our team has risen to overcome challenges and seize opportunities to accomplish our mission and the recent news about our lunar trial and moves US one step closer to making go of therapy available to many more patients who may benefit from TT fields.

I want to reiterate my things to the entire Novocure team for their continued dedication to our mission to extend survival and some of the most aggressive forms of cancer.

With that I will turn the call over to Ashley to discuss our financial results for the quarter.

Asaf Danziger: Time and time again, our team has risen to overcome challenges and seize opportunities to accomplish our mission. The recent news about our Lunar Trial moves us one step closer to making our therapy available to many more patients who may benefit from titifil. I want to reiterate my thanks to the entire Novocure team for their continued dedication to our mission to extend survival in some of the most aggressive forms of cancer. With that, I will turn the call over to Ashley to discuss our financial results for the quarter.

Thank you and staff.

And the first quarter of 2021, our GBM business generated a $135 million and net revenue rep.

Presenting a 32% year over year increase.

Our net revenue growth was driven by steady active patient growth and a durable and president and the net revenue per active patient.

Incremental net revenue, resulting from the successful appeal of previously denied Medicare fee for service and interest rates revert to normalized levels from the first half of 2020.

As a result quarter over quarter revenue comparisons must and just for the incremental $8 million and $11 million net revenue recorded in the third and fourth quarter 2020, respectively.

Ashley Cordova: In the first quarter of 2021, our GBM business generated $135 million in net revenues, representing a 32% year-over-year increase. Our net revenue growth was driven by steady active patient growth and a durable improvement in net revenue per active patient. Incremental net revenues resulting from the successful appeal of previously denied Medicare fee-for-service beneficiaries reverted to normalized levels from the first half of 2020. As a result, quarter-over-quarter revenue comparisons must adjust for the incremental $8 million and $11 million net revenues recorded in the third and fourth quarters of 2020, respectively. While we continue to actively appeal and pursue previously denied claims, the cadence and size of Medicare payments on these claims are impossible to predict.

While we continue to actively appeal and pursue previously denied claims the cadence and size of Medicare payments on these claims are impossible to predict.

We had 3454 at the patients at the end of the first quarter and increase of 12% versus the first quarter of 2020, and a 1% increase versus the fourth quarter of 2020.

Over the past several years, we have seen a notable stable both delta between the growth rate of prescriptions received and Peoria and active patients and net revenue as we reap the benefit of patient mix improvement and broadening reimbursement law.

Looking ahead, we expect the favorable difference and growth rates among these metrics to compressed as a commercial organization matures.

Ashley Cordova: We had 3,454 active patients at the end of the first quarter, an increase of 12% versus the first quarter of 2020 and a 1% increase versus the fourth quarter of 2020. Over the past several years, we have seen a notable, favorable delta between the growth rates of prescriptions received in the period, active patients, and net revenues, as we reap the benefit of patient mix improvements and broadening reimbursement. Looking ahead, we expect the favorable difference in growth rates among these metrics to compress as our commercial organizations mature.

Moving down the P&L gross profit and the first quarter of 2021 was the 108 million.

The 80% gross margin.

We continue to see the benefits of the increased efficiencies and scale within our supply chain.

Our SG&A expenses and the corner were $62 million and increase of 13% from the Q1 2020 net.

This reflects our ongoing commitment to maintain a disciplined approach to spending to support the growth of our established commercial businesses as well as the organizational readiness efforts and anticipation of potential future approvals and new indications.

Our capital allocation priorities remain unchanged and we continue to invest strategically to maximize the growth potential of the tumor treating fields platform.

Ashley Cordova: Moving down the P&L, gross profit in the first quarter of 2021 was $108 million, with an 80% gross margin. We continue to see the benefits of increased efficiencies and scale within our supply chain. Our SG&A expenses in the quarter were $62 million, an increase of 13% from Q1 2020. This reflects our ongoing commitment to maintain a disciplined approach to spending to support the growth of our established commercial businesses, as well as organizational readiness efforts in anticipation of potential future approvals and new indications.

We invested $46 million and research and development activities and the quarter and increase of 82% versus Q1 2020.

This was primarily due to an increase and clinical trial and personnel expenses for our phase III pivotal and post marketing trials.

And increase in development and personnel expenses to support our product development programs and increased investments and preclinical research and the expansion of our medical affairs activities.

Moving forward, we remain committed to balancing profitability with and Gregg with aggressive investments and future growth.

Our net loss for the quarter was $4 million equating to a loss of <unk> <unk> per share.

Ashley Cordova: Our capital allocation priorities remain unchanged, and we continue to invest strategically to maximize the growth potential of the tumor treating fields platform. We invested $46 million in research and development activities in the quarter, an increase of 82% versus Q1 2020. This was primarily due to an increase in clinical trial and personnel expenses for our Phase 3 pivotal and post-marketing trials, and increasing development and personnel expenses to support our product development program.

We remain committed to making the investments needed to advance our development programs and solidify our commercial infrastructure prior to teach from potential launches and additional solid tumor indication.

The recent announcement regarding our lunar trial only underscores the size of one potential opportunity present, and our late stage pipeline.

Our focus remains on optimizing investment and future growth of for near term profitability.

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

Ashley Cordova: Increasing investments in preclinical research and the expansion of our medical affairs activities. Moving forward, we remain committed to balancing profitability with aggressive investments and future growth. Our net loss for the quarter was $4 million, equating to a loss of $0.04 per share. However, we remain committed to making the investments needed to advance our development programs and solidify our commercial infrastructure prior to future potential launches and additional solid tumor indications. The recent announcement regarding our lunar trial only underscores the sizable potential opportunity present in our late-stage pipeline.

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 the best reflects the financial value generated by our business.

And the first quarter of 2021 of our adjusted EBITDA was $21 million and increase of 40% from the same period and 2020.

We ended the quarter with the $864 million and cash on hand, we remain confident that our current balance sheet and continued generation of financial strength provide the backstop to continue aggressively investing in the future growth of our company.

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

Ashley Cordova: Our focus remains on optimizing investments and future growth before near-term profitability. Beyond earnings per share, we also evaluate 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.

Thank you Ashley.

We believe multiple levers remain to unlock the full potential of the tumor treating fields platform.

Through our ongoing preclinical and clinical research efforts, we continue to explore and many new therapy combinations applications and downstream effects of tumor treating fields. The.

More we learned about our therapy. The more we believe we are only beginning to understand its full potential.

Our existing late stage pipeline programs create the potential for substantial market expansion into new solid tumor indications over the next few years and.

Ashley Cordova: In the first quarter of 2021, our adjusted EBITDA was $21 million, an increase of 40% from the same period in 2020. We ended the quarter with $864 million in cash on hand. We remain confident that our current balance sheet and continued generation of financial strength provide the backstop to continue aggressively investing in the future growth of our company. With that, I will turn the call back to Bill to provide more detail about our development pipeline.

In addition to our lunar trial discussed earlier, we have ongoing phase III trials in ovarian cancer, one of the deadliest cancers for women and pancreatic cancer, where there has been very little progress in recent years and.

And brain metastases caused by non small cell lung cancer.

Our innovate three trial represents an opportunity to address the large unmet need and continue our exploration of the effect of tumor treating fields and combination with best standard of care.

Almost all patients with recurrent ovarian cancer ultimately develop platinum resistance and the prognosis for these patients remains poor.

William F. Doyle: We believe multiple levers remain to unlock the full potential of the tumor-treating field platform. Through our ongoing preclinical and clinical research efforts, we continue to explore many new therapy combinations, applications, and downstream effects of tumor-treating fields. The more we learn about our therapy, the more we believe we are only beginning to understand its full potential.

Innovate three test the efficacy of tumor treating fields used together with the Taxane chemotherapy paclitaxel.

We currently anticipate the interim analysis for innovate III and the third quarter of 2021 with 18 months follow up.

Our <unk> III trial in pancreatic cancer also addresses of cancer with poor prognosis and significant unmet need.

And five year survival rates and pancreatic cancer remained below 10%.

William F. Doyle: Our existing late-stage pipeline programs create the potential for substantial market expansion into new solid tumor indications over the next few years. In addition to our lunar trial discussed earlier, we have ongoing phase 3 trials in ovarian cancer, one of the deadliest cancers for women, where there has been very little progress in recent years, and Brain Metastases Caused by Non-Small Cell Lung Disease. Our Innovate III trial represents an opportunity to address a large unmet need and continue our exploration of the effective tumor treating fields in combination with the best standard of care. Almost all patients with recurrent ovarian cancer ultimately develop platinum resistance, and the prognosis for these patients remains poor.

Following promising data and our pilot phase II trial and over three test the effectiveness of tumor treating fields used with weekly Nab Paclitaxel and gem side of me.

The interim analysis of <unk> III is expected to occur next year with final data in late 2023.

These two trials represent exciting steps and our efforts to expand the use of tumor treating fields to cancers of the abdomen.

Our late stage pipeline also includes the Metis trial and brain metastases from non small cell lung cancer.

<unk> presents a unique opportunity when compared to our other late stage trials as it expands the scope of our research and non small cell lung cancer and a region of the body where of therapy has already demonstrated the ability to kill dividing cancer cells.

Net is designed to measure and extension to intracranial progression of six months, we expect the final data from our Metis trial and 2022.

William F. Doyle: Innovate 3 tests the efficacy of tumor treating fields used together with the Taxane chemotherapy Paclitax. We currently anticipate the interim analysis for Innovate3 in the third quarter of 2021 with 18-month follow-up. Our PANOVA-3 trial in pancreatic cancer also addresses a cancer with poor prognosis and significant unmet need; five-year survival rates in pancreatic cancer remain below 10 percent. Following promising data in our pilot phase two trial, PANOVA3 tests the effectiveness of tumor treating fields used with weekly NAB-Paclitexel and Gemcitabine. The interim analysis of PANOVA-3 is expected to occur next year, with final data in late 2023.

All of our late stage trials offer unique attributes that will enhance our understanding of the optimal use of tumor treating fields. The.

The address different regions of the body unique combination therapies and distinct cancer indications.

These trials could increase our potential market opportunity by 20 fold.

We also believe we can continue to improve our therapy through investments and product innovation programs intended to extend survival and maintain the quality of life of our patients are.

Our product development teams remain focused on delivering product innovations that prioritize patient and usability and increasing the delivered dose of tumor treating fields.

We are evaluating opportunities to optimize the tumor treating fields electric field generator.

Design next generation of race and create patient centric software, enabling our team to support larger populations across multiple indications.

William F. Doyle: These two trials represent an exciting step in our efforts to expand the use of tumor-treating fields to cancers of the abdomen. Our late-stage pipeline also includes the METIS trial in brain metastases from non-small cell lung cancer. MEDIS presents a unique opportunity when compared to our other late-stage trials as it expands the scope of our research in non-small cell lung cancer in a region of the body where our therapy has already demonstrated the ability to kill dividing cancer cells. Netis is designed to measure an extension, to intracranial progression, of six months. We expect the final data from our METIS trial in 2022.

Beyond our current clinical pipeline exciting research is ongoing to identify new cancer indications combinations and novel applications for tumor treating fields of therapy.

Through in vitro application researchers at Virginia Tech have concluded the tumor treating fields may be effective for treatment of renal cell carcinoma.

Investigators at Beth Israel, Deaconess Medical Center, and Washington University of St. Louis are exploring the effect of tumor treating fields and addition to immunotherapies for the treatment of melanoma brain Mets.

Dr Kerr and now.

And story at southwestern Medical Center in Dallas of identified a novel action of tumor treating fields and DNA damage repair and replication stress pathways. These examples are small sample of the innovative research being conducted to identify the optimal use of tumor treating fields.

William F. Doyle: All of our late stage trials offer unique attributes that will enhance our understanding of the optimal use of tumor treating fields. They address different regions of the body, unique combination therapies, and Distinct Cancer Indications. These trials could increase our potential market by 20 fold.

As we continue to accumulate more knowledge and evidence of the many potential applications of tumor treating fields.

William F. Doyle: We also believe we can continue to improve our therapy through investments in product innovation programs intended to extend survival and maintain the quality of life of our patients. Our product development teams remain focused on delivering product innovations that prioritize patient usability and increase the delivered dose of tumor-treating fields. We are evaluating opportunities to optimize the tumor treating field's electric field generator, design Next Generation Arrays, and create patient-centric software enabling our team to support larger populations across multiple indications.

We have even greater confidence that we are just beginning to understand the true potential of the platform.

Before I hand, the call over to the operator for questions I would like to thank everyone on the phone for their continued interest in Novocure are.

Our team delivered another strong quarter of commercial execution positioning us to continue investing and the advancement of our clinical and product development initiatives and and organizational readiness efforts to sustain long term growth and maximize shareholder value.

We remain confident of our team our strategy, our mission and the long term potential of tumor treating fields.

With that I'll now turn the call back over to the operator for Q&A.

Thank you.

William F. Doyle: Beyond our current clinical trials, exciting research is ongoing to identify new cancer indications, combinations, and novel applications for tumor treating fields therapy. Through in vitro application, researchers at Virginia Tech have concluded that tumor treating fields may be effective for the treatment of renal cell carcinoma. Investigators at Beth Israel Deaconess Medical Center and Washington University of St. Louis are exploring the effect of tumor-treating fields in addition to immunotherapies for the treatment of melanoma brain death.

And gentlemen, API of a question at this time just press Star then one on your telephone keypad.

Your question first of all hash key.

Again that is one star one to getting the Q1 moment, while we compile the Q&A roster.

The first question is from Jason Bednar with Piper Sandler Your question. Please.

Hey, good morning, and thanks for taking the questions Bill I wanted to start with lunar.

Probably not surprised and a lot of questions that have obviously come up here just regarding how to interpret the release and I'm sure those will be discussed here today, but why don't I asking what's the assumed the FDA approves the idea of whats the right way to think about timing and then on hitting that the recommended 276 of enrollment target. It seems like it shouldnt be that long and weaker the enrolment of $2.

William F. Doyle: Dr. Karanam, and Story at Southwestern Medical Center in Dallas have identified a novel action of tumor treating fields in DNA damage repair and replication stress pathways. These examples are a small sample of the innovative research being conducted to identify the optimal use of tumor-treating fields. As we continue to accumulate more knowledge and evidence of the many potential applications of tumor treating fields, we have even greater confidence that we are just beginning to understand the true potential of the platform.

And in February and the original and term that was slated for later this year.

And then building on that whats the right way to think of how the timeline and then could play out for data presentation and submission for approval assuming the data all looks good.

So good morning, Jason and.

Thanks for your question and you are right.

Not surprising.

William F. Doyle: Before I hand the call over to the operator for questions, I would like to thank everyone on the phone for their continued interest in NOMIC. Our team delivered another strong quarter of commercial execution, positioning us to continue investing in the advancement of our clinical and product development initiatives and in organizational readiness efforts to sustain long-term growth and maximize shareholder value. We remain confident in our team, our strategy, our mission, and the long-term potential of tumor-treating fields. With that, I'll now turn the call back over to the operator for Q&A.

So.

Basically where we stand today.

In order to meet the the.

Target recruitment that was recommended by the DMC, we need to recruit approximately 60 more patients.

And so the trial.

And.

We will certainly be the focus of our organization too.

Work with investigators to actively get those patients recruited.

Another important part of the recommendation of the DMC was to reduce the follow up from the last patient in and this is important from the last patient in 12 months from 18 months. So that's another time savings and.

Operator: Thank you. And ladies and gentlemen, if you have a question at this time, just press star and then one on your telephone keypad. To withdraw your question, press the hash key. Again, that is star one to get in the queue. One moment while we compile the Q&A roster. Our first question is from Jason Bednar with Piper Sandler. Your question, please.

And we would expect as we have done previously a modular submission of.

And the PMA application.

With the the.

And the clinical component being the last part so we're already beginning to work on the.

The other modules of the submission.

So in general we.

Jason M. Bednar: Hey, good morning. Thanks for taking the questions. You know, Bill, I wanted to start with Lunar. I probably won't be surprised at a lot of questions that have obviously come up here, just regarding how to interpret the release. And I'm sure those will be discussed here today. But, you know, why don't I ask, you know, let's assume the FDA approves the IDE, you know, what's the right way to think about timing then when it comes to hitting that recommended 276 enrollment target?

If the FDA.

Except the recommendations of the DMC, we think this would excel.

Accelerate our time to market by over a year.

Okay. Okay. That's helpful and you know a lot of other questions and have them that they will say those for later.

And you want to ask a question on the on the commercial business.

And so.

And bill or actually the.

The impact from COVID-19 seems to effect of the business. Most here in the U S, but it's probably safe to assume you're feeling some disruption and your other markets as well.

So for the use of our international whatever however, you want to answer it I mean can you talk about what you saw with prescribing patterns during the quarter and then here into April.

Jason M. Bednar: It seems like it shouldn't be that long when we pair the enrollment of 210 in February and the original interim that was slated for later this year. And then, you know, building on that, what's the right way to think about how the timeline then could play out for data presentation and submission for approval, assuming the data all looks good? It will certainly be the focus of our organization to work with investigators to actively get those patients recruited.

Sure. So we are joined for the Q&A by protest Shaw, our chief commercial officer, and I'm going to just turn the call to protect cash who will give you the.

And the color to answer your question.

Great. Thank you Bill and good morning, Jason. Thank you for the question so.

One of the key things that we've been focused on and the mist or the backdrop of the pandemic is to make sure that no patient is left behind those patients that are eligible for our treatment find a way to accenture and treatment and then on the back end of that we make sure that our teams are prepared to help the patients initiate treatment.

Jason M. Bednar: Another important part of the recommendation of the DMC was to reduce the follow-up from the last patient in, and this is important, from the last patient in at 12 months from 18 months, so that's another time savings. And we would expect, as we have done previously, a modular submission of the PMA application with the clinical component being the last part. So we're already beginning to work on the other modules of the submission.

And provide support.

And we realize that we're not immune to all of the things that are happening in the healthcare sector, particularly in the oncology sector of these patients are immuno compromised and many situations and their ability or their desire to seek treatment maybe a bit Ltd. So we see these the micro fluctuations if you will based on.

Jason M. Bednar: So in general, we... If the FDA accepts the recommendations of the DMC, we think this would accelerate our time to market by over a year. Okay, okay, that's helpful. And there are a lot of other questions I have on that, but I'll save those for later.

And what's happening within.

The pandemic across the globe and we see sometimes markets that are.

Little bit more open access to the health care is a bit better, but then something may happen, where that may shut down. So we are flexible on this front and if you if you really look below the broad.

Jason M. Bednar: I do want to ask a question on the commercial business. So, you know, Bill or Ashley, you know, the impact from COVID, you know, seems to affect the business most here in the US, but it's probably safe to assume you're feeling some disruption in your other markets as well. You know, so for the US or international, whatever, however you want to answer it, I mean, can you talk about what you saw with prescribing patterns during the quarter and then here into April? Sure, so we're joined for the Q&A by Pritesh Shah, our Chief Commercial Officer, and I'm going to just turn the call to Pritesh, who will give you the color to answer your question. Great.

Results of the 3500 over almost 3500 active patients you see that the greatest impact was felt in the U S and this quarter and that was primarily because of the patient traffic that we saw those seeking surgeries and the early part of the year, we saw a bit of a pressure point on that and our therapy is downstream to that.

So we are a bit.

Sort of relying upon patients getting the surgical resection. So we keep on top of this and we are flexible, but we're not seeing sort of the broad aspects because GBM is still an important disease, where patients and providers are looking to make sure that they get patients on treatment.

Alright, Thank you very much.

Our next question comes from the <unk> Kumar with Evercore ISI. Your question. Please.

Pritesh Shah: Great. Thank you, Bill. And good morning, Jason.

Congrats on the.

And the lunar interim update and I had three questions, maybe I'll start with the lunar.

Pritesh Shah: Thank you for the question. So one of the key things that we've been focused on in the midst or the backdrop of the pandemic is to make sure that no patient is left behind. Those patients that are eligible for our treatment find a way to access our treatment. And then on the back end of that, we make sure that our teams are prepared to help those patients initiate treatment and provide support.

I guess.

Bill maybe at the high level could you just simplify.

And what this means for the company the.

The GM and we get the approval what does the FDA label going to look like what does the patient population.

Understanding of the GBM patient pool.

10000, maybe second line of 40 to 50000 and is this a very simplistic way.

Thinking about this as four to five ex Tam.

Pritesh Shah: We realize that we're not immune to all the things that are happening in the health care sector, particularly in the oncology sector. These patients are immunocompromised in many situations, and their ability or their desire to seek treatment may be a bit limited.

Tam expansion and how does that.

And what the perhaps up.

And the standard of care.

Given the given these patients.

And Brazil came out of the first line.

So good morning, Vijay and thanks for your question I'll start with we are extremely ex.

Pritesh Shah: So we see these micro fluctuations, if you will, based on what's happening within the pandemic across the globe. And we see sometimes markets that are a little bit more open to access to health care are a bit better, but then something may happen where that may shut down. So we are flexible on this front.

Excited by the recommendations of the DMC and it really has kicked off a whole.

The.

Set of streams of activities within the company too.

To prepare for expansion of the of the business into new and into this new area.

Pritesh Shah: And if you really look below the broad results of the 3,500, almost 3,500 active patients, you see that the greatest impact was felt in the US in this quarter, and that was primarily because of the patient traffic that we saw. Those seeking surgeries in the early part of the year, we saw a bit of a pressure point on that, and our therapy is downstream from that. So we are a bit sort of relying upon patients getting the surgical resection.

I'll also say.

Again, just before I answer the question, specifically that Luna is one component of a much broader lung cancer program.

And at Novocure.

In the script I mentioned the met its trial to treat brain metastases from non small cell lung cancer. We also mentioned our collaboration with MST and first line non small cell lung cancer in combination with Keytruda.

Pritesh Shah: So we keep on top of this, and we are flexible, but we're not seeing sort of the broad aspects because GBM is still an important disease where patients and providers are looking to make sure that they get patients on treatment. All right, thank you very much.

And there's just a tremendous amount of other work.

And our ISP program and our preclinical program across the board in and.

And non small cell lung cancer and all.

Also mentioned that just as you said at the very top line, our focus and our tumor treating fields development is to provide the background pardon me of a new backbone modality.

Vijay Kumar: Our next question comes from Vijay Kumar with Evercore ISI. Your question, please.

Vijay Kumar: Congratulations on the Lunar interim update, and I had three questions. Maybe I'll start with the Lunar...

Vijay Kumar: I guess, Bill, maybe at a high level, could you just simplify what this means for the company? Does it mean we get the approval?

Two which whatever of the standard of care.

In pharmacology of balls to can be added.

What does that mean.

Vijay Kumar: What is the FDA label going to look like? What is the patient population? My understanding of this GVM patient population.

That means that the standard of care is chemotherapy, we would expect the chemotherapy to be added to tumor treating fields. If it's radiotherapy and we would expect radiation to be added to the tumor treating fields and I have to say.

Vijay Kumar: [inaudible]

William F. Doyle: So, good morning, BJ, and thanks for your question. You know, I'll start with, we are extremely excited by the recommendations of the DMC, and it really has kicked off a whole set of streams of activities within the company to prepare for the expansion of the business into this new area. I'll also say, again, just before I answer the question specifically, that Lunar is one component of a much broader lung cancer program at Novocure. In the script, I mentioned the MEDIS trial to treat brain metastases from non-small cell lung cancer. We also mentioned our collaboration with MSD in first-line non-small cell lung cancer in combination with Katruda.

Very exciting for all of us.

Just on what we're seeing and our and our preclinical work and now and our clinical work.

Adding the new immunotherapies to tumor treating fields. So this really is about a broad based program, but the <unk>.

Specifically.

And it's estimated that there are about 193000, new cases of of non small cell lung cancer diagnosed and the U S. Each year.

About 46000 of those patients receive second line treatment for stage four and the U S. Each year, so within the narrow confines.

And that's the number and as you suggest that's just that number is the is four to five ex where.

William F. Doyle: And there's just a tremendous amount of other work in our IST program, in our preclinical program, across the board in non-small cell lung cancer. I also mentioned that, you know, just as you said, at the very top line, our focus in our tumor treating fields development is to provide a background, pardon me, a new backbone modality to which whatever the standards of care in pharmacology evolve to can be added. What does that mean?

Where we are.

Advanced or metastatic non small cell lung cancer is commonly treated with platinum based therapies and the first line and.

And lunar was designed again with arms.

In combination with chemotherapy and and arm in combination with the.

Immunotherapy to contemplate this this changing.

Standard of care that we see.

Understood and then.

William F. Doyle: That means that the standard of care is chemotherapy. We would expect the chemotherapy to be added to tumor treating fields. If it's radiotherapy, we would expect radiation to be added to tumor treating fields. And I have to say in...

And just one I guess that the later this summer.

I don't think many of us were.

And if I had to go back to the six months ago.

We weren't expecting an interim look at rates I think the messaging was.

The east trials for and design.

William F. Doyle: So very exciting for all of us based on what we're seeing in our preclinical work and now in our clinical work, adding new immunotherapies to tumor treating fields. So this really is about a broad-based program, but specifically, you know, it's estimated that there are about 193,000 new cases of non-small cell lung cancer diagnosed in the U.S. each year. About 46,000 of those patients receive second-line treatment for stage 4 in the U.S. each year.

We need to show efficacy of signal and trim.

I guess in the context of Luna.

How should we think about the Woodbury and interim readout.

And what is the standard of care and ovarian.

Is that.

The first line chemo as the standard of care.

Okay.

So.

Again with respect to each of our.

Late stage phase III trials.

Each one of those trials is designed specifically for that indication.

Each one of those trials has its own data monitoring committee.

So we would continue to recommend and we continue to believe that those trials will.

William F. Doyle: So within the narrow confines, that's the number, and as you suggest, just that number is 4 to 5x where we are. Advanced or metastatic non-small cell lung cancer is commonly treated with platinum-based therapies as the first line. And Lunar was designed, again, with arms in combination with chemotherapy and an arm in combination with immunotherapy to contemplate this changing standard of care that we see. I don't think many of us were, you know, if I had to go back three to six months ago, we weren't expecting an interim update, but I think the messaging was good.

Recruit through there.

Two of their conclusion.

We allow very little alpha spend.

For the for the interim analysis.

And so again notwithstanding the great news for lunar I wouldn't suggest that any one change.

Change their expectations for the for the other trials.

With respect to ovarian cancer, specifically, we mentioned and the.

In the script.

The first line for.

Again may move over time, but.

Vijay Kumar: These trials were designed to show efficacy of the signal at interim. I guess in the context of Lunar, what should we think about Ovarian?

Most women will ultimately fail.

And therapy or first line therapy, and then progress and once they progress into the <unk>.

William F. Doyle: ovarian intermediary, and what is the standard of care in ovarian cancer is that you know first line, and chemo is the standard of care. So, again, with respect to each of our late stage phase three trials, each one of those trials is designed specifically for that indication. Each one of those trials has its own data monitoring committee. So we would continue to recommend, and we continue to believe, that those trials will recruit to their conclusion. We allow very little alpha spend for the interim analyses.

<unk> line the prognosis is very poor.

Our innovate trial.

Our first trial phase III trial in ovarian cancer is focused on that population that sales first line therapy.

Understood and then one last quick one if I may actually.

The CMS.

The backlog payments is that.

I guess.

The based on in the back half of last year.

Last year's trends.

Vijay Kumar: And so, you know, again, notwithstanding the great news for Lunar, I wouldn't suggest that anyone change their expectations for the other trials. With respect to ovarian cancer specifically, we mentioned in the script that the first line for the disease may move over time, but most women will ultimately fail platinum therapy or first-line therapy and then progress. And once they progress into second line, their prognosis is very poor. Our Innovate trial, our first phase three trial in ovarian cancer, is focused on that population that has failed first-line therapy.

What's the zero being recognized in Q1 are.

Is that just a timing element, perhaps of CMS processing and some fees with less or should we model.

Yes.

No further contribution from.

And the catch up payments.

Yes. Thank you Vijay it's an important point for our remaining of realized as we look forward to the models that we continue to aggressively pursue these claims and there was a significant volume of potential there and the backlog from Medicare prior to receiving coverage for operating in newly diagnosed GBM, but the cadence and <unk>.

And collections and it simply impossible to predict and for that reason I would not recommend that to you that you can do that and airport parking Amato right. This is this is out of our control we pursue these again aggressively but.

Vijay Kumar: And then one last quick one, if I may, Ashley, the CMS backlog payments, is that, I guess, you know, based on, you know, the back half of last year, last year's trends, versus zero being recognized in Q1, is that just a number?

And the impossible to predict in terms of the Cana emphasize.

And thanks guys.

Yes.

Our next question is from.

At the say young with Mizuho.

And.

Hi, Good morning. This is Dan Clark on for <unk>, just one from US can you share the frequency of DMC meetings and your ongoing clinical trials and does this vary by indication.

Vijay Kumar: Timing element, perhaps, you know, CMS processing some of these requests.

Vijay Kumar: Some of these requests should be modeled, I guess, without further contribution from catch-up payments. Yeah, thank you, Vijay. It's an important issue.

And we last year.

Al.

Sorry can you hear me now.

Yes, yes, okay.

The fairly.

Ashley Cordova: Yeah, thank you, Vijay. It's an important point for everybody to realize as we look forward to the model. So we continue to aggressively pursue these claims, and there is a significant volume of potential there in the backlog from Medicare prior to receiving coverage for opting for a newly diagnosed QBM.

Simple answer.

<unk>.

The.

For each of these trials.

The DMC meets once a year.

Okay got it thank you.

Our next question comes from Jason <unk> with Northland capital.

And Jason <unk> from Northland Capital Your line is open.

Ashley Cordova: But the cadence and size of collections are simply impossible to predict. And for that reason, I would not recommend that you attempt to do that in your forward-looking model, right? This is out of our control. We pursue these, again, aggressively, but really impossible to predict in terms of cadence and size.

Jason We don't hear you if you're speaking.

Please check your mute button.

Sir with your permission I can most of the next question.

Larry <unk> with Wells Fargo. Please go ahead.

Hey, good morning, guys. Thanks for taking the question Bill can you hear me okay.

I can't Larry Good morning.

Wanted to make sure just two on lunar.

Desai Yang: Our next question is from Desai Yang with Mizuho.

When the results came when the press release came out.

And we thought it was.

Dan Clark: Hi, good morning. This is Dan Clark from DFAY. Just one question from us: can you share the frequency of DMC meetings in your ongoing clinical trials? And does this vary by individual?

Highly positive, but some of the experts we've talked to have said the DNC is communication to you is highly unusual. So I guess my first question is how confident are you that the dmc's recommendation is positive could there be other scenarios that are not positive and is there a precedent and I had one follow.

Sure.

Dan Clark: Dan, we lost you.

Okay.

So there's two parts of that we believe.

Unknown Executive: Yes. Yes. Okay. Yes, simple answer: for each of these trials, the DMC meets once a year.

And we're highly confident that this is a very positive.

Event, and a very positive communication from the DNC, we don't believe Theres another way.

Jason Weitz: Our next question comes from Jason Weitz with Northland Capital. Jason from Northland Capital, your line is open.

Jason Weitz: Jason, we don't hear you if you're a speaker.

To interpret this just as simple as that.

Operator: Please check your mute button. Sir, with your permission, I can move to the next question. Larry Biegelsen with Wells Fargo. Please go ahead.

That said, we are not aware of the precedent.

This type of recommendation and.

It's very specifically stems from the fact that.

Lawrence H. Biegelsen: Hey, good morning guys. Thanks for taking the question. Bill, can you hear me okay? I can. Larry, good morning. Just wanted to make sure.

Because of COVID-19.

The time to recruit.

The trial extended beyond which beyond the time that.

Lawrence H. Biegelsen: Bill, just two on Lunar. When the results came in, when the press release came out, you know, we thought it was, you know, highly positive. But some of the experts we've talked to, you know, said the DNC's communication to you is highly unusual. So I guess my first question is, how confident are you that the DNC's recommendation is positive? Could there be other scenarios?

It was originally anticipated.

And as a result, there were more.

Events.

And they have the they have the full data they were able to do the statistical analysis and they were able to.

Make the recommendations debt that they made.

And then what does it mean, possibly unethical to randomize patients to the control arm whats the rule for determining whether the ethical or not and why didn't they just stop the trial and now and how do you randomize. The final 60 patients if it's possibly unethical thanks for taking the questions.

William F. Doyle: Other scenarios that are not positive, and is there a precedent, and I have one follow-up. So there's two parts to this, and we're highly confident that this is a very positive event and a very positive communication from the DNC. We don't believe there's another way to interpret this, just as simple as that. That said, we are not aware of a precedent for this type of recommendation, and it very specifically stems from the fact that

Yes, so again.

We haven't seen the data.

I think the the words speak for themselves.

The the reason the.

William F. Doyle: Because of COVID, the time to recruit the trial extended beyond the time that was originally anticipated. As a result, there were more events, and they had the full data. They were able to do the statistical analysis, and they were able to make the recommendations that they made.

Again likely cannot stop the trial at this point is because of the very small alpha spend allowed in the.

And the analysis.

And we're going to work with all of our investigators too.

Lawrence H. Biegelsen: And then what does it mean possibly unethical to randomize patients?

To quickly enroll the the.

The remaining 60 patients again patients and the control arm do receive the standard of care.

Unknown Executive: Transcripts provided by Transcription Outsourcing, LLC.

Unknown Executive: Unknown Executive, Asaf Danziger, Ingrid Goldberg, Novocure Ltd Yeah, so again, I, you know, I haven't seen the data. I, I think the words speak for themselves.

Just minus the tumor treating fields.

Just maybe lastly, but what happens if the FDA does not approve the protocol change is there any risk of that thanks again.

Again, we are we are working with the FDA.

William F. Doyle: The reason they, Again, likely cannot stop the trial at this point is because of the very small alpha spend allowed in the analysis. And we are going to work with all of our investigators to quickly enroll the remaining 60 patients. Again, patients in the control arm do receive the standard of care, just minus the tumor treating field. And just maybe lastly, Bill, what happens if the FDA does not approve the protocol change? Is there any risk for that?

Have submitted.

The E pardon me with the.

Too many too many acronyms, which submitted the PMA supplement.

With the DMC.

And the recommendation so.

And so far so good.

And where we're in.

Interacting with the FDA.

And there are a variety of outcomes possible.

And we will.

Lawrence H. Biegelsen: Thanks again. Again, we are working with the FDA, we have submitted the IDE, pardon me, too many acronyms, we've submitted the PMA supplement with the DMC recommendation, so far, so good. You know, we're interacting with the FDA. There are a variety of outcomes possible, and we will, when we have the final determination from the FDA, we'll make that information available to everyone. Thanks so much, Bill.

And when we have the final determination from the FDA, we will make that information available to everyone.

Alright, thanks, so much bill.

Okay.

Our next question comes from Cory <unk> with Jpmorgan.

Question and a couple of them for you. So first bill on this issue of these interim analyses and keeping expectations and check I totally understand your not wanting investors to get out over their skis, so to speak but opportune did hit the interim for GBM, obviously one of the most.

Corey Langer: Our next question comes from Corey Casimov with J.P. Morgan.

Corey Langer: question. I have a couple of them for you. So first, Bill, on this issue of these interim analyses keeping expectations in check. I totally understand you not wanting investors to get excited.

And the worst and most difficult to treat tumors out there and then you believe youre very close on long, which clearly of Super complicated indication at this point, so why shouldn't we have more expectations for ovarian and pancreatic Interims and then I have one follow up.

Corey Langer: their skis, so to speak, but you know Optune did hit the interim for GBM, obviously one of the most

William F. Doyle: which is clearly a super complicated indication at this point. So why shouldn't we have more expectations for ovarian and pancreatic interims? And then I have one following question.

Yes.

Corey.

First of all I want to reiterate.

The statement that we don't want investors to get out over their skis. If we did would tell you.

Corey Langer: Yeah, I think Corey. First of all, I want to reiterate the statement that we don't want investors to get out over their skis. If we did, we'd tell you. The situation with GBM was extraordinary. The situation with non-small cell lung cancer, as I just mentioned, was a function of the duration of the recruiting, clearly, as well as the performance. If I were to use the ovarian cancer trial in A3, that's recruiting very, very quickly, and so we expect that to complete recruitment, as we said, by Q3. And again, the interims have such a small alpha spend that we just don't, I'll use your phrase, we just don't think investors should get out over their skis on these other trials. They're all different. Okay, and then just to follow up this interim, as it relates to the ongoing METIS trial in brain METS, I mean, this has been on track for final analysis in 2022.

The the situation with GBM was extraordinary.

The situation with the non small cell lung cancer.

As I, just mentioned was a function of the duration of the recruiting.

Clearly as well as the the performance.

If I were to use the ovarian cancer trial innovate three that's recruiting very very quickly.

And so we expect that the complete recruitment as we said.

By Q3 and and.

And again, the Interims have such a small alpha spend.

Net debt.

We just don't.

I'll use your phrase we just don't think investors should get out over their skis and these other trials. They are all different okay. And then just a follow up it is the interim as it relates to the ongoing metis trial and brain Mets.

It's been on track for a final analysis and 2022, but was there of prior interim efficacy analysis conducted for this and I think you said you would do this for all of your trials.

Corey Langer: But was there a prior interim efficacy analysis conducted for this? I think you said you do this.

Corey Langer: that you do this for all of your trials. So is there anything you can comment on that? This is the one exception, Corey. So MEDIS is the one trial in the late-stage pipeline that does not have it.

Yes. So is there any of this is the one exception.

And Corey.

So medicines the one trial of the of the late stage pipeline that does not have an interim analysis.

Okay. So the DMC is just doing the annual safety check and that's it.

Correct, Okay, and any particular reason why you wouldn't have put one and on that one.

William F. Doyle: Okay, so the DMC is just doing the annual safety check, and that's it.

Let me or he's on the call and he was very much involved with the trial designs already do you have the.

Corey Langer: Okay, any particular reason why you wouldn't have put one in on that one? Let me know. Uri's on the call, and he was very much involved with the trial designs. Uri, do you have any color on the design for Metis?

Any color on the design of medicine.

And good morning, everybody and.

And so the reason why we don't have an interim analysis on the Matthew studies that the study of smaller basically at the 170 patients and the.

And we did not want to.

Uri Weinberg: Yes, good morning everybody. So the reason why we don't have an interim analysis in the METI study is that the study is smaller, basically, 270 patients, and we did not want to cause any deterioration in terms of the statistical considerations in this study, and so on this one, we do not have an interim analysis. It's for 270 patients with brain metastasis from an osmocell lung cancer with the primary endpoint of intracranial progression, and there was no need to include an interim analysis in this study. Okay.

Cause if you.

Aberration in terms of masterpiece kind of considerations on the study and.

So on this one we do not have in each of them on ICT for 270 patients.

And rain and what that says the SaaS from and non small cell lung cancer and.

And with the primary endpoint of intracranial progression and there was no need to include the interim analyses from the Swan.

Okay. Thank you that's helpful.

Thank you. Our next question is from Jason with the Northland. Please go ahead.

Thank you and hopefully you can hear me apologies, yes, and congrats to you now.

Yes, Scott route and stop by and through my phone and the apparently the <unk> button got stuck with the Ambac for thank you.

Corey Langer: Thank you. Thank you.

So first off you guys seem to be and I wouldn't say doubling down but more direct in terms of.

Operator: Thank you. Hopefully, you can hear me. Apologies. Yes, we can.

Jason Weitz: In terms of the fact that there's an amplification effect with immunotherapies, is that based on new animal data or preclinical data that you've done, or is there some read-through as well from the Lunar announcement that just came out? Yeah, I'm gonna ask Uri to comment on that.

The fact that there is an amplification of effect with immuno therapies.

Is that based on new animal data or preclinical data that you've done or is there some read through as well from.

The lunar.

Announcement.

And so just came out.

Yes.

The comment on this but I would say that just start with the fact that.

William F. Doyle: But I would say that, you know, just start with the fact that we've now been fully engaged in research and development for over 20 years. And with the financial strength that Ashley described, we're able to significantly expand research and development activities, plus our support of external investigators. And this is generating tremendous amounts of data, and we're really just beginning to reap the benefits of these investments now. And I'll let Uri comment specifically on the reason for our increasing enthusiasm about combinations with immunotherapy.

We have now been fully engaged in research and development for over 20 years.

And with the financial strength that Ashley.

The described we're able to significantly expand the.

The research activities and development activities, plus our support of external investigators.

And this is generating tremendous amounts of of of data.

And we're really just beginning to reap the benefits now of these investments and I'll, let <unk> comment specifically on the reason for our increasing.

Enthusiasm of that combinations with Immunotherapies.

Uri Weinberg: Thank you, Bill. What we do already know is that tumor-treating fields lead to immunogenic cell death in multiple models of cancer in vitro and in vivo. And we have demonstrated that specifically in lung cancer, in colon cancer, and in other models. What we basically were able to demonstrate, and this is published data, is that cells that are treated with CT fields express hallmarks of immunogenic cell death, specifically cal-reticuling exposure on the surface of the cells, release of HMGB1, and release of ATP.

Uh huh.

Thank you Bill so what we do already know is net tumor treating fields the lead to immunogenic cell death, and multiple models of cancers.

And in vitro and in vivo and we have demonstrated that specifically.

And the lung cancer and <unk>.

And the colon cancer and and other of modules and what we.

We basically were able to demonstrate mdc's published data is that sales that are treated with DTC. That's expressed hallmarks of immunogenic cell death.

Typically kind of articulating exposure on the surface of the sales and release of <unk>, one and release of the ADP. All of these serve as cigna's for antigen presenting cells like dendritic cells to act as the.

Uri Weinberg: All of these serve as signals for antigen-presenting cells, like dendritic cells, to act as phagocytic cells, meaning they would process antigens that are presented by the cancer cells. Then, they will present them to the effector cells, like T-cells, in order to activate them and increase and augment the immune response against the cancer. And this was demonstrated in vitro and also in vivo, and was accompanied by an augmentation of the overall immune response against the cancer at the tumor sites in animals, with the infiltration of T-cells, cytotoxic T-cells, in the tumor, a decrease in the volume of the tumor, of course, and an increased abundance of antigen-presenting cells also residing at the tumor site.

The site.

Health net meaning that they would.

The process antigens that are presented by that and.

Cost of ourselves of the day, we'll present them to the.

The effect ourselves to T cells, the in order to activate them and the increase and augment the immune response against the cancer.

And this was demonstrated in vitro and also in vivo and was accompanied by and augmentation of the overall immune response against the cancer tumor size and animals, where things will creation of.

T Cells' cytotoxic T cells in the tumor decrease and the volume of the tumor of course aim and.

And increased the abundance of antigen presenting cells also residing in the debt.

Humor site.

Uri Weinberg: When we combined CT fields with anti-PD-1 therapy, we saw an increase in this response and better control of the tumors, and a better response of the tumor. And that, of course, comes together with data that comes from other sites, from other researchers that use TT fields independently outside of NovoCure, such as Dr. David Tran at the University of Florida, who is running research that shows another path of activation of the immune system under TT fields.

When we combined the details with the anti PD one therapy, we saw an increase of the response and.

And the better.

The control of the Humira has met the response of the tumor and.

And that of course.

Together with the data that's come from other sites from other researchers debt that.

Use the TT fields and.

Independently outside of novel cure, such as the Doctor David trend at the University of Florida.

And who is running our research that shows another path of.

Innovation of the immune system and the TT fields and.

Uri Weinberg: And that explains the results that we see in patients. And basically, all of this preclinical data translates very nicely to what we do in the clinic right now. So, Lunar is an excellent example, and I think we covered enough about Lunar during the call, but the integration of immune checkpoint inhibitors concomitant with TT fields now seems to be even more logical and makes more sense than when we started the study several years ago.

And that explains the results net debt.

Debt, we've seen patients and basically all of these preclinical data translates very nicely to what we do in the clinic and right now. So Lunardi is an excellent example, and I think we expanded enough on the lunar one of the call and bought the integration of immune checkpoint inhibitors concomitant with debt.

<unk> and <unk>.

And now seems to be even more and larger kind of makes more sense than when we started the study and several years ago, but in addition to that the keynote <unk> <unk> study that.

Uri Weinberg: But in addition to that, the Keynote B36 study that is running in collaboration with MSD and Merck that will incorporate pembrolizumab, Keytruda, with TT fields as the first-line therapy for osmosis lung cancer is another great example. And we are going to, I believe, see more of these projects and more towards the combination with immunotherapies in the clinic later on.

And Ronnie and collaboration with MSB with Merrick.

And that will and.

Incorporate the <unk> keytruda with the <unk> is the first line therapy and off and non small cell lung cancer is another great example, and we are going to and I.

And I believe a C Moore.

Of these projects and more towards.

And the combination with Immunotherapies in the clinic later on.

Jason Weitz: Okay, thank you. That's very helpful. And actually, related to Keynote 336, you know, given the Lunar announcement, that potentially could be very exciting. Do you have a general timeline in terms of

Okay. Thank you that's very helpful and actually related to keynote and 36.

Given the Luna.

Announcement.

And that potentially could be very exciting.

Our road of general timeline in terms of of how long that trial will take to enroll and and get results.

Jason Weitz: A general timeline in terms of how long that trial will take to enroll and get results.

And so we are currently.

As of.

Uri Weinberg: So we are currently in the phase of working with the sites in order to open the study, and we have assembled a steering committee for the study that includes leading key opinion leaders such as Corey Langer from UPenn and Anne Tsao from MD Anderson, and we will for sure announce the timelines that are anticipated for the completion of the study once we see the first patient.

Working with the sites in order to open the study and.

And then we.

We have assembled the steering committee and.

On the study that includes <unk>.

Leading key opinion leaders such as Corey Langer from you ban are and so from MD Anderson, and we would and for sure and announce the timelines that day.

And our anticipated for the completion of the study one and we.

We see the first patient.

Jason Weitz: Okay, thank you very much. And lastly, you mentioned NPM is, is, you know, a relatively small contribution, if any, at this point. It sounds like we shouldn't be assuming much for this year.

Okay.

Thank you very helpful and lastly.

You mentioned MTM as is.

The relatively small contribution.

If any at this point it sounds like we shouldnt be assuming.

Much for this year.

William F. Doyle: Specifically for MPM, is that the right read-through for those comments? Yeah, so I think so.

And specifically for <unk> is that the right read through for those comments.

Yes, I think that's exactly the right read through we continue to be.

William F. Doyle: Yes, I think that's exactly the right read-through. We continue to be very enthusiastic, very active, engaged with centers and payers, but we don't expect material net revenue contribution in 2021.

The very enthusiastic very active and engaged with.

The centers and payers.

Jason Weitz: Okay, great. Thank you. I'll jump back in the queue. Thank you very much.

But we don't expect material net revenue contribution in 2021.

Great. Thank you I'll jump back in queue. Thank you very much.

Operator: Thank you, and I'm not showing any further questions in the queue, sir.

Thank you and I'm not showing any further questions and Nikki and Sir.

William F. Doyle: Okay, great. So I want to thank everyone for their interest in Novocure. I want to thank the Novocure team for their brilliant work, quite frankly, in very difficult circumstances. And I want to end by reminding everyone of our strategy. We have a new modality that is broadly applicable to solid tumor cancers.

Okay, great. So I wanted to thank everyone for their.

Interest and Novocure I want to thank the Novocure team for their.

Brilliant work quite frankly and the <unk>.

Very difficult circumstances.

And I want to and by reminding everyone of our strategy.

We have a.

A new modality.

That is broadly applicable to solid tumor cancers.

William F. Doyle: The strategy of the company is to develop that platform and serve all the patients who can benefit from our therapy around the world. The strategy specifically has been to develop the first business in GBM. That business still has a long way to go, but it has provided great financial strength so that we're financially independent, and we can make tremendous investments in the platform to drive future growth. I think the fact that we were able to invest $46 million last quarter in R&D really points to what I've described as a virtuous cycle: build the GBM business, generate financial strength, and invest in clinical and product development to further drive patient benefit and

The strategy of the company.

And is to develop that platform and serve all of the patients.

Who can benefit from our therapy around the world.

The strategy specifically has been to develop the first business.

And in GBM.

That business.

<unk> has a long way to go but has provided.

Great financial strength.

So that we're financially independent and we can make tremendous investments in the platform to drive future growth I think the fact that we've been able to.

Invest $46 million last quarter and <unk>.

R&D really points to what I've described as the as a virtuous cycle.

Build the GBM business generate financial strength invest in clinic.

Clinical and product development and further drive patient benefit and long term growth. We are just at the beginning of seeing the benefits of that virtuous cycle. We've tried to highlight some of the things.

William F. Doyle: We are just at the beginning of seeing the benefits of that virtuous cycle. We've tried to highlight some of the things on the clinical side this quarter on this call, but it is a tremendously exciting time at Novocure and we look forward to future reports as we continue our work. Thank you.

In the in the clinical side and this this quarter and this fall.

But it is a tremendously exciting time.

And over cure and we look forward to the future reports as we continue our work. Thank you.

Operator: And this concludes today's conference call. Thank you for your participation, and you may now disconnect.

And this concludes today's conference call. Thank you for your participation and you may now disconnect.

And.

And.

Okay.

Yes.

[music].

And.