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NovoCure Limited (NASDAQ: NVCR)
2020 first quarter earnings call
May 2, 2020, 10:00 pm. ET
Content:
- Prepared observations
- Questions and answers
- Call participants
Prepared observations:
Operator
Ladies and gentlemen, thanks for waiting. And welcome to the NovoCure First Quarter 2020 Earnings Conference Call. [Operator Instructions)] Please note that today’s conference is being recorded. [Operator Instructions]
Now I would like to address the conference to your speaker today, Ashley Cordova, Senior Vice President of Finance and Investor Relations. Please go ahead, ma’am.
Ashley Cordova – Vice President of Finance and Investor Relations
Good morning to everybody. And thanks for joining us to review NovoCure’s first quarter 2020 performance. On behalf of the entire NovoCure team, we would like to start by wishing you well as we collectively face the challenges of the COVID-19 pandemic. We hope that you and your loved ones stay healthy and safe during this unprecedented time.
With security in mind, we are making today’s call virtually. I am accompanied by our Executive President, Bill Doyle; our CEO Asaf Danziger; and our CFO, Wilco Groenhuysen. Pritesh Shah, our Commercial Director; and Ely Benaim, our Medical Director, are also available and available for questions and answers.
This morning, we will first focus on our response to COVID-19, and then provide our standard updates on first quarter performance. The slides presented today can be viewed on our website, www.novocure.com, by clicking on the link for the first quarter 2020 financial results located in the Events section on our Investor Relations page.
Before we begin, I would like to remind you that our discussions during this conference call will include forward-looking statements, and actual results may 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 the risks and uncertainties described from time to time in our filings with the SEC. We do not intend to publicly update any forward-looking statements, except as required by law.
Following our prepared comments today, we will open the line for questions. Finances for the three months ended March 31, 2020 are available in our press release and in our 10-Q; which we launched early this morning. In your case, we will refer to non-GAAP financial measures to evaluate our business. Reconciliations of non-GAAP financial measures to GAAP financial measures are also included in our press release and the accompanying slide appendix accompanying this filing and on our Form 8-K filed with the SEC today. These materials can be accessed from the Investor Relations page of our website, www.novocure.com.
With that, I will now pass the call on to Bill Doyle.
William F. Doyle – CEO
Thank you Ashely and good morning everyone. While the past two months have been unprecedented as we adjust to the realities of the COVID-19 global pandemic, we believe that the fundamental perspectives for our business have not changed. That said, we have had to adjust the way we do business to adapt to the changing situation of COVID-19. We have implemented measures across our organization to continue to provide Tumor Treatment Camps therapy to patients while protecting the NovoCure community worldwide.
In an effort to minimize the spread of the virus, we have instituted work-at-home policies for employees, who are not directly involved in operations or patient support. Our global operations centers remain open, but we have segregated them into zones to minimize person-to-person contact. We are monitoring the elements of our global supply chain in an effort to ensure that we maintain adequate inventories of all key products. Our patient support teams in the field continue to conduct in-person visits when appropriate and leverage technology to serve our patients virtually. Our award-winning nCompass team continues to provide phone and email support 24 hours a day, seven days a week.
We continue to treat current clinical trial patients and enroll new patients at existing clinical trial sites in our six ongoing clinical trials. Despite these efforts, enrollment in clinical trials has been adversely affected by COVID-19. Specifically, the expansion of the clinical trial site has been, and we believe will continue to be, materially delayed as the sites devote significant resources to COVID-19.
We believe that the value of the Tumor Treating Fields platform, the resilience of our direct patient business model, and the long-term potential of our business remain intact. Over the past 20 years, we have created an organization of 850 colleagues dedicated to administering tumor treatment fields, our life-prolonging therapy, to patients with glioblastoma or mesothelioma, and dedicated to conducting clinical and product development programs aimed at to extend survival in some of the most aggressive forms of cancer. Despite the challenges presented by COVID-19, we continue to advance our programs to achieve these goals.
The company surpassed several major milestones in the first quarter with more than $ 100 million in net revenue, more than 3,000 active therapy patients, and more than 500 million lives covered worldwide. Our financial strength allows us to continue investing in innovation, and we believe it positions us well to navigate through the substantial uncertainty that plagues our industry. The need to treat patients with aggressive cancers does not decrease with COVID-19. And we trust our team, our strategy, and the core value proposition of the Tumor Treating Fields platform.
I will share more details about our clinical portfolio later in the call this morning, but first, I will pass the call on to Asaf to share his perspective on the quarter and recent events. Asaf?
Asaf Danziger – Executive Director
Thanks Bill. In the first quarter of 2020, NovoCure generated another strong frontline growth quarter with a record $ 102 million in global net revenue, an increase of 39% compared to the first quarter of 2019. Our net revenue growth was fueled for continued active patient growth and expansion of Optune reimbursement.
We ended the first quarter with 3,095 active therapy patients, representing an 18% increase year-over-year and a sequential quarterly increase of 6%. The volume of recipes also grew. We received a total of 1,409 prescriptions in the first quarter, and the mix of newly diagnosed GBM prescriptions remained close to 80%.
We believe that our performance in the first quarter highlights the ingenuity and commitment of our team to serve our patients and their families. COVID-19 is changing the way we interact with healthcare providers, but our customer engagement teams remain focused and in execution mode. We respect all institutional restrictions on outside visitors to the cancer centers, hospitals, and research institutions we serve. While this has resulted in a decrease in in-person connection, in many cases, it is creating new opportunities to engage customers. We rapidly develop multiple virtual engagement tools to connect with healthcare professionals and to enable information sharing.
To give an example, we recently launched a four-part TTFields webcast series on the use of telemedicine, delivery of treatment in an outpatient setting, and remote administration of treatment with Optune. We just did the second part of the series on Tuesday night to connect with doctors from GBM and MPM; many of which face competing priorities, limiting their availability.
We continue to host virtual speaker programs and highlight the benefits of home treatments, particularly for vulnerable patient populations. Our medical affairs team will lead a round table, plan to define new clinical guidelines for managing patient care in these difficult times. We have also configured virtual chat capabilities for our patient ambassadors that are resources available to patients, caregivers, and physicians. Maintaining access to this program is an important way to forego the Optune patient experience in the dialogue between teams of healthcare providers and patients diagnosed with GBM or MPM.
Beyond our sales and marketing efforts, we continue to advance our product development programs aimed at improving patient efficacy and usability. In response to the social distancing related to COVID-19, we are currently evaluating the expedited regulatory approval option to launch our MyLink [Phonetic] remote download capabilities ahead of originally planned. This technology will allow us to download data remotely from a patient’s TTFields generator without the need for an in-person visit. We believe that our ongoing product development programs have the potential to significantly improve patient outcomes as we work to extend survival in some of the most aggressive forms of cancer.
Our senior management team continues to monitor the development of COVID-19 and ensure a coordinated response at our global sites. The situation is challenging for all of us, but I can assure you that we are as focused as ever on driving TTFields commercialization and development.
With that, I’ll call Bill back to share some details about our clinical trials.
William F. Doyle – CEO
Thanks Asaf. We believe that the mechanism of action of Tumor Treatment Fields is broadly applicable to solid tumor cancers. Our scientific research spans two decades. And in all of our preclinical and clinical research to date, Tumor Treating Fields has demonstrated a consistent anticancer effect. The results of EF-19, our latest clinical trial data set, were presented earlier this week at the Virtual Annual Meeting I. of the American Association for Cancer Research 2020. Study EF-19 was ordered by the FDA to confirm the efficacy of tumor treatment fields versus best standard of care for recurrent GBM in the post-approval real-life setting.
EF-19 studied Optune as monotherapy for the treatment of recurrent GBM in 192 patients compared to 117 patients with recurrent GBM who received better-care chemotherapy in the NovoCure EF-11 registry trial. In EF-19, monotherapy with Optune reduced the risk of death with fewer adverse events compared to chemotherapy with a better level of care. For patients who received at least one course of therapy, Optune prolonged survival by a median of 1.7 months. No new safety signs were observed. EF-19 data confirmed the effectiveness and safety of Optune and further strengthened Optune’s clinical profile in the GBM indication.
Our extensive preclinical and clinical evidence provides the basis on which we are executing a strategy to advance the Tumor Treatment Fields through additional clinical research studies in multiple types of solid tumors. We are currently running six clinical programs evaluating the use of tumor treatment fields, including four key phase 3 randomized trials: the METIS trial on brain metastases; the LUNAR trial in non-small cell lung cancer; the PANOVA-3 trial in pancreatic cancer; and the INNOVATE-3 trial in ovarian cancer.
As we entered the quarter, our patient enrollment projections for LUNAR and PANOVA-3 were based on increases in the number of clinical trial sites to accelerate enrollment. As we contacted METIS researchers throughout the quarter, we also initiated plans to expand the study’s footprint in additional countries to accelerate enrollment. Our expansions of clinical trial sites have been materially delayed as sites dedicate significant resources to COVID-19. While we continued to evaluate the start of new clinical trial sites using a risk-based framework, in accordance with local regulations and site policies, we were able to incorporate only two new sites for these trials in March.
We continue to work closely with institutions, local authorities and contract research organizations to maintain commitment and refine our processes in order to advance our clinical research studies. We have implemented virtual site startup visits and developed remote monitoring capabilities. Despite these efforts, we expect the challenges with clinical site initiation and patient enrollment to continue at least through the second trimester. As a result of these delays, we are now projecting final data from METIS in 2022. In addition, we now anticipate that final data from the LUNAR and PANOVA-3 trials will be available in 2023 with planned tentative analyzes based on enrollment in 2021. These projections they are based on our current enrollment rate as well as the anticipated impact of the COVID-19 pandemic on global health systems.
The groups of the European Network of Gynecological Oncology Trials and the third-party clinical trial networks of the GOG Foundation collaborate with us in our fundamental trial INNOVATE-3 Phase 3 and facilitate enrollment in the main cancer centers. Despite delays in expanding the clinical trial site related to the global COVID-19 pandemic, INNOVATE-3 patient enrollment trends continued to exceed our expectations in the first quarter, driving an acceleration in our enrollment schedule anticipated. We now await final INNOVATE-3 data in 2023 with an enrollment-driven mid-term analysis in 2021.
We remain optimistic about the potential to significantly expand the addressable market for tumor treatment fields with key dataset readings anticipated for the next three years. We will continue to provide updates in the future as we gain clarity on the duration of COVID-19’s impact in the clinical trial environment.
With that, I will forward the call to Wilco to discuss our financial results.
Wilco Groenhuysen – CFO
Thanks Bill. NovoCure ended the first quarter in a solid financial position. We continue to progress in the development of our commercial business, generating first quarter net income of $ 102 million, representing a growth of 39% compared to the first quarter of 2019.
Our year-over-year revenue growth was driven by both an 18% increase in active patients and a 15% improvement in average net income reserved per active patient. The increase in revenue per patient benefited from improved reimbursement rates, particularly in the United States.
Access to our therapy continues to grow in our active markets, which we believe demonstrate an increase in recognition by health insurers of the value of tumor treatment fields. In March, the German Federal Joint Committee, or G-BA, established the national reimbursement for Optune in newly diagnosed GBM, after a comprehensive assessment of benefits. We believe that further redemption expansion in our currently active markets is an important lever for continued revenue growth.
Specifically, we recognized $ 7 million in first-quarter net income from Medicare beneficiaries, built under the positive coverage policy. We are working on typical administrative acceleration with Medicare and we expect our net income from Medicare beneficiaries to improve further as we have an experienced process. At the end of the quarter, half of our active Medicare patients began treatment after September 1, 2019, the effective date of the Medicare coverage policy.
Moving P&L down, gross profit in the first quarter was $ 77 million, reflecting a 76% gross margin. Our capital allocation priorities remain unchanged and we continue to invest in innovation as part of our long-term value creation strategy.
R&D expenses in the quarter totaled $ 25 million, 48% more than in the first quarter of 2019, reflecting our continued commitment to investments in clinical and product development aimed at extending survival in multiple cancers solid tumor. We anticipate that R&D expenditures will continue to increase in future quarters as we move forward in these development programs.
Our SG&A expenses for the first quarter were $ 55 million, 30% more than in the first quarter of 2019, driven primarily by an increase in marketing expenses related to the launch of Optune Lua and the increased personnel costs to support our growing commercial business.
In the first quarter, we recorded an income tax benefit of $ 11 million as a result of losses net of operating losses in the US. In accordance with changes in the US tax code. USA Enacted in response to the economic impacts of COVID-19.
Our net income was $ 4 million with $ 0.04 in earnings per share, our third consecutive quarter of positive net income. We also evaluate our operating performance based on adjusted EBITDA, a non-GAAP measure of earnings before interest, taxes, depreciation, amortization, and stock-based compensation. Adjusted EBITDA increased by $ 10 million, or 176%, to $ 15 million for the three months ended March 31, 2020 from $ 5.0 million for the three months ended March 31, 2019. This improvement in financial performance Fundamental was fueled by front-line growth and disciplined execution
We ended the quarter with $ 331 million in cash, cash equivalents and short-term investments, an increase of $ 5 million from the previous quarter. We remain committed to improving financial, operational and capital efficiency while maintaining a balanced focus on growth, profitability and liquidity.
Before turning the call over to the operator for questions and answers, I would like to thank everyone on the phone for their continued interest in NovoCure. The aggressive cancers we treat don’t slow down because of COVID-19, and we remain as focused as ever on delivering our therapy to patients who trust us. Innovation is one of the defining values of NovoCure, and this innovation is tangible as we adapt in real time to ensure that patients have access to the therapy and support they need.
We continue to monitor the potential impacts of COVID-19 and will adapt our plans as necessary to mitigate potential risks as we gain new insights. Our first quarter performance highlights a history of execution with progress in the commercial business and continued financial strength. We believe that the fundamental perspectives of our business do not change, and our focus is unwavering in strengthening our existing base and advancing clinical and product development programs aimed at unlocking future value.
Thanks for your time this morning. With that, I will forward the call to the operator for questions.
Questions and answers:
Operator
Thank you. [Operator Instructions] Our first question comes from Larry Biegelsen with Wells Fargo. Your line is now open.
Unidentified participant
Hello everyone. Thanks for answering the question. This is Kevin for Larry this morning. The first is just looking at the total TRx. It came better than expected in the first quarter. And now, understanding the fundamental need to treat aggressive cancers doesn’t diminish with COVID-19, as you mentioned. I am curious to know if you could analyze the growth trend in January, February versus the last two weeks of the March output growth rate. If you could supply any color by geography it would be useful too. I am also curious if you can express your thoughts on the Rx growth that you are seeing in April so far, if you can share it. Is it more or less the same, or is it fair to assume that it is worse than the March rate? And then I just have a follow up. Thank you.
William F. Doyle – CEO
Yes, good morning Kevin. This is Bill. As Ashley mentioned at the top of the call, we are all remote, literally in different parts of the world. So I’m going to be a little more directive in questions and answers than usual because we’re not all in the same room. Pritesh, maybe it makes sense for you to comment on Kevin’s questions regarding TRxs and trends.
Pritesh Shah – Commercial Director
Of course. Kevin, thanks for the question. So in the first quarter, something that was important from a milestone point of view is that we approved in the first quarter more than $ 100 million in net revenue, more than 3,000 active patients, and more than 500 million lives covered. Now this further strengthens our core capacity as a business organization to continue treating more patients with GBM and MPM. With that, we also received over 1,400 prescriptions in the first quarter of 2020, representing sequential growth of 2% and annual growth of 8%. We do not analyze what is happening month by month. We share it together. And one of the things we shared with you in the opening remarks is that we saw no material change in our commercial business in the first quarter. And based on what we know today, we do not anticipate a material impact on our commercial business in the future, now that we realize that we have just finished, a third of the second quarter. That is based on what we are seeing today. This is what we can share with you.
Unidentified participant
Perfect. That’s useful.And then only my follow-up is on the clinical updates. You have three interim analyzes of the Phase 3 trials to be conducted in 2021. Do you have an idea of the cadence from the point of view of when each of them may arrive next year? Thank you.
William F. Doyle – CEO
Yes. So I think one of the things that is important to understand is that when we start a test, we project a recruitment goal. We have a number of levers that we used during the test, including site participation and site expansion. Today we do not project the specific order of those trials. We will provide additional details as we enter 2021 and the situation with COVID and the situation at test sites becomes clear.
Unidentified participant
OK thanks. That’s useful. Actually, if I could sneak one more. I was just curious to know if – you are seeing that COVID has an impact on the start of new patients, as you mentioned. Does it also affect active patients? In other words, should we expect a drop in active patients in the second trimester in addition to new patient starts? Are there different trends and behaviors in the United States by geography there? Thank you.
William F. Doyle – CEO
Yes. So Kevin, this is a very important point, which is when we talk to some of our other colleagues in the medical technology field, clearly there have been dramatic impacts because even, unbelievably, cardiac surgeries are considered optional surgery and are postponed on this moment. point. Our patients with these extremely aggressive cancers remain in therapy. And we continue: we have made real-time adjustments to the way we interact with our patients and caregivers. Therefore, we see no disruption to our ability to treat our patients in therapy, and that includes our commercial patients and our clinical trial patients. And we are maintaining patient beginnings. So I think it’s also an important point to mention. So, just supplementing or building on what Pritesh said, we don’t expect to see a change in our commercial business as a result of COVID-19.
Unidentified participant
Perfect. Thanks for answering the questions, guys.
Operator
Thank you. Our next question comes from Vijay Kumar with Evercore ISI. Your line is now open.
Vijay Kumar – Evercore ISI Equities Institutional – Analyst
Hello guys. Thanks for answering my question. So Bill, maybe one in the clinical trial deadlines. [Phonetic] Oddly So we had some jostling, but we also had some forward jerking. If we go deeper into it, I think the press release had LUNAR as number three in its vignette. I don’t know if that’s an indication of the timeline of the first half versus the second half of ’21. And on the ovarian side, the pull-forward, why do you think enrollment goes faster? Is this upper half because it is a more global test versus LUNAR? Therefore, any comments I think would be helpful.
William F. Doyle – CEO
Yes. Good morning Vijay. So first of all let me be clear; the order in the press release is unrelated to the projected timeline. And as I said earlier, when we start these tests, we make certain assumptions, certain projections, and we have certain levers that we pull during the test. So a perfect example stands out that sometimes our projections are overestimated and others are underestimated. As testing progresses, we begin to gain more clarity on the details of the moment. In normal times we have things that we adjust. And again, we mention site engagement and number of sites. And that’s what we’ve clearly thrown the curve with COVID-19. But in this case, as you said, INNOVATE is getting ahead of the initial projections.
Vijay Kumar – Evercore ISI Equities Institutional – Analyst
I have you. And one about script volumes, if I can. Is it a fair statement to assume that there is some impact in April due to your patients’ ability to visit their doctors and treat doctors? And if that’s the case, once the locks are lifted, is there any delay when starting the reference channel? I guess just since this is cancer, the return should be very, very fast. Thank you.
William F. Doyle – CEO
Yes, Vijay, I will only repeat what Pritesh said earlier just to emphasize this. Unlike many or most medtech companies, the need to treat patients with aggressive cancers has not been affected by COVID-19. And based on what we know today, we do not anticipate a material impact on our commercial business in the future.
Vijay Kumar – Evercore ISI Equities Institutional – Analyst
That is extremely useful. Thanks guys.
Operator
Thank you. Our next question comes from Difei Yang with Mizuho. Your line is now open.
Difei Yang – Mizuho Securities USA LLC – Analyst
Hello good day. Thanks for taking my questions. Congratulations on the great first quarter. So a few questions. Could you give us a little more information regarding what you are doing differently after COVID to get patients started, in such a way, because the start of a new patient is phenomenal? It is very impressive. I’m just curious, what is the sequence of events you did to maintain that?
And then secondly, if you could give us an update on what’s happening with the approval of WBG in China. Have they returned to work?
William F. Doyle – CEO
Of course. So good morning, Difei, and thanks for the congratulations and thanks for your questions. I am going to pass the call on to Pritesh to answer questions about what we are doing differently. But I do want to congratulate our teams for moving extremely fast to implement changes. And Pritesh, maybe you can describe some of the specific things that we’re doing.
Pritesh Shah – Commercial Director
Of course. Thanks, Bill, and thanks for the question. In fact, I am extremely proud of how quickly we have adapted. And in our adaptation, some things led us to take the steps we have taken. En primer lugar, queríamos garantizar la seguridad y, en segundo lugar, asegurar la continuidad de la atención ya que los pacientes estaban siendo tratados por GBM y MPM. Entonces, en los primeros días de exposición a COVID, queríamos asegurarnos de tener opciones para los médicos que querían tratar a los pacientes con Optune, y una de esas opciones incluía inicios virtuales. Y esto requería que nuestros equipos aprovecharan la tecnología para apoyar a los pacientes en nuestros mercados activos de acuerdo con las regulaciones locales, porque también nos enfrentamos a diferentes regiones y diferentes provincias que tienen diferentes conjuntos de regulaciones. Entonces, una forma en que pudimos lograr esto, por ejemplo, es usando la plataforma GoToMeeting con pacientes. Tuvimos nuestro primer inicio virtual en Hawai, por ejemplo, donde no es del todo remoto, pero definitivamente está aislado del continente en los EE. USA Eso nos dio algo de experiencia, lo que nos permitió adaptarnos a otros inicios que hemos realizado en el entorno virtual. Por lo tanto, seguimos ofreciendo hoy dos oportunidades para que los pacientes comiencen el tratamiento. Una es asegurarse de que puedan aprovechar esta plataforma virtual. El segundo es que todavía estamos realizando arranques en vivo con equipo de protección personal completo. Entonces, este tipo de dos opciones nos permiten centrarnos en las necesidades del equipo de atención, así como de los pacientes. En el frente de los proveedores de atención médica, también nos aseguramos de que tengan la educación que necesitan y los recursos y las herramientas que necesitan para apoyar a los pacientes. En este frente, también nos comprometemos virtualmente y nos aseguramos de ofrecerles oportunidades para ver y sentir el apoyo que estamos brindando.
Y finalmente, nuestro equipo nCompass permanece disponible para los proveedores, así como para los pacientes. Y este es nuestro equipo de personas que están apoyando a pacientes y proveedores por teléfono virtualmente, así como también por teléfono. Por lo tanto, estas son algunas de las formas en que nos hemos adaptado y nos hemos asegurado de garantizar la continuidad de la atención a los pacientes que realmente necesitan nuestro tratamiento.
William F. Doyle – Presidente ejecutivo
Gracias Pritesh. Y Difei, con respecto a Zai, diré que nuestra asociación con Zai es más fuerte que nunca. Y además del trabajo en GBM, son … Les recordaré a todos, son nuestros socios clínicos, y tenemos un ensayo abierto sobre cáncer gástrico ahora abierto en Hong Kong. Con respecto a la posible aprobación de GBM en China continental, el sentimiento de Zai no ha cambiado, y se están preparando activamente para las operaciones comerciales para un lanzamiento en China en el corto plazo.
Difei Yang – Mizuho Securities USA LLC – Analista
Gracias Bill. Una pregunta, solo un seguimiento con respecto al estudio EF-19. Entonces, ¿cómo planearía aprovechar el resultado de ese estudio, además de cumplir con el requisito reglamentario?
William F. Doyle – Presidente ejecutivo
Entonces, gracias por la pregunta. Entonces, esta fue una prueba cuando recibimos nuestra primera aprobación de PMA basada en nuestros resultados de la prueba EF-11 en GBM recurrente. Se lo recordaré a todos, ya que fue hace mucho tiempo. Esa fue una prueba que comparó la monoterapia con Optune con la mejor quimioterapia de atención estándar. Entonces no fue así: Optune no se usó en combinación con quimioterapia. Fue utilizado como monoterapia. Cuando se presentaron y aprobaron esos datos, era la primera vez que la FDA había tratado con Optune. Y entonces solicitaron, o no debería decir que solicitaron, exigieron que hagamos un ensayo posterior a la aprobación. Ese ensayo posterior a la aprobación, como se describió en el comunicado de prensa a principios de esta semana, se leyó en la Reunión Anual de la AACR, y quedamos muy satisfechos, porque en este caso los datos mostraron superioridad en el entorno de la vida real respecto a los controles del ensayo clínico.
En general, creemos que estos datos confirman la efectividad y seguridad de Optune y fortalecen nuestro perfil clínico en general. Por supuesto, nuestro enfoque se ha movido ahora a GBM recién diagnosticado. Creemos que eso es: en combinación con la quimioterapia, creemos que ahí es donde los pacientes obtienen el mayor beneficio. Pero esto fue solo otra confirmación del valor de la terapia Optune para pacientes con GBM.
Difei Yang – Mizuho Securities USA LLC – Analista
Yes. Gracias Bill. Y si me permite una última pregunta. ¿Espera hacer un estudio similar para el GBM recién diagnosticado?
William F. Doyle – Presidente ejecutivo
La FDA no ordenó un estudio de seguimiento en GBM recién diagnosticado. El próximo estudio que hemos planeado en GBM recién diagnosticado es el estudio TRIDENT, que hemos descrito, que evaluará el uso de Optune con radiación en comparación con el uso de Optune después de la radiación. Y esperamos que el ensayo comience la inscripción en breve, y publicaremos el primer paciente en ese estudio.
Difei Yang – Mizuho Securities USA LLC – Analista
Gracias Bill.
Operador
Thank you. Our next question comes from Esther Rajavelu with Oppenheimer. Your line is now open.
Esther Rajavelu – Oppenheimer & Co. Inc. — Analyst
Good morning, and thank you for taking my questions. Just a couple from me. First, for the US market, can you give us some color on the Medicare patient split in your active patients and in your new script numbers?
William F. Doyle – Executive Chairman
Of course. So, thanks Esther. I’m going to turn it to Wilco who maybe will comment on the mix of Medicare versus commercial patients in the US.
Wilco Groenhuysen – Chief Financial Officer
Yes. Thanks, Bill. Good morning, Esther. The mix is effectively unchanged, Esther. We talked about 25% of the population in the past, and that’s what we’re seeing today with [Phonetic] newly diagnosed versus recurrent GBM, but it’s the general population. So it’s also somewhat comparable to the overall trend, I would say. I think worth noting, and we mentioned it on the script, is that we are making considerable progress in recognizing revenue for the Medicare population. And it’s directly correlated with the number of active patients that have started therapy after September 1 when the coverage policy became effective. And we’re now at approximately 50% rate, and we of course expect that to go up further in the near future.
Esther Rajavelu – Oppenheimer & Co. Inc. — Analyst
Thank you. And then in terms of the COVID-19 impact, can you maybe share any insights on — these are oncology trials and they’re life and death situations. So, can you maybe compare the impact in your trial enrollment generally and your timelines versus some of the other oncology trials that may be ongoing?
William F. Doyle – Executive Chairman
Again, we don’t comment on others’ trials. I mean we read them and follow them as you do, and we see that some have stopped completely. Others have had difficulty with their follow-ups of patients, etc. As we said, we are continuing to treat our current clinical trial patients, and we continue to enroll new patients at existing clinical trial sites in our six trials. That said, our trial sites are clearly distracted, or many of them are clearly distracted for COVID-19, and that’s why we changed the projections as we did this morning.
Esther Rajavelu – Oppenheimer & Co. Inc. — Analyst
Okay. So, I guess would it be accurate to — or would it be more accurate to assume that the sites that are already open are enrolled — the enrollment rate there is fine. It’s more the delay in onboarding new sites that’s affecting the timelines?
William F. Doyle – Executive Chairman
The delay in onboarding new sites is the principal reason for the delay. But as you can imagine, the centers vary all over the place, depending on where they are in the world and where their regions are with respect to the specifics of the pandemic. So it’s not a question that has a blanket answer.
Esther Rajavelu – Oppenheimer & Co. Inc. — Analyst
Got it. And my last question. In terms of some of the changes that you’re doing to your infrastructure with the sales and marketing and potentially shipping products, are those changes you think — or those — do you view those as temporary, or would some of those potentially be permanent changes as you think about maybe views on driving efficiencies?
William F. Doyle – Executive Chairman
Yes. So first of all, again, I’m going to start by congratulating the organization. And it’s not just the commercial organization. It’s our clinical organization, our operations organization, our financial, our legal. All of our various departments have had to make dramatic changes. Those that are not required to be in the office are all working from home, as I know many of you are as well. Even within our operation centers, we’ve changed the way that we package and ship and receive materials to minimize exposure of employees to one another. And we’re leveraging technology across the organization.
The simple answer to your question is I think that many of the things that we’re doing have improved the efficiency of the organization, have accelerated our ability to scale across very large populations. And these are things that we will maintain and continue to build on as we go forward post-pandemic.
Esther Rajavelu – Oppenheimer & Co. Inc. — Analyst
Excelente. Thank you. Congrats.
Operator
Thank you. Our next question comes from Cory Kasimov with JPMorgan. Your line is now open.
Cory Kasimov – JPMorgan Chase & Co. — Analyst
Hey, good morning guys. Thanks for taking my questions. I guess first of all on LUNAR, given how this treatment landscape continues to evolve, curious to get your take on the possibility of potential breakdown of patients enrolling that are actually in the third line-plus setting versus second line. Are you still expecting predominantly second line or more of a mix now? And I have a follow-up.
William F. Doyle – Executive Chairman
Yes. So LUNAR is studying, as you know, Tumor Treating Fields with PD-1 inhibitors, or docetaxel, for second-line treatment of non-small cell lung cancer. We absolutely understand that the landscape for non-small cell lung cancer is changing and is competitive. That being said, Cory, I’ll remind everyone what you know is that Tumor Treating Fields is designed to be used with the best standard of care pharmacology. We’ve never seen an accumulative toxicity, and we’ve always seen additivity or synergism. So, we expect that this will be used with whatever emerges as the best standard of care. The study was designed to generate data that contemplates multiple outcomes, and we believe all of them are clinically meaningful for patients, regardless of the ultimate line.
Cory Kasimov – JPMorgan Chase & Co. — Analyst
Okay. And then I wanted to follow up on some of the earlier questions on your patient interactions. Optune, TTF’s obviously a different type of product offering in many ways; one of which is how the company trains the patients at home rather than a physician or a nurse doing it in office. So, is that approach resonating in this environment? I guess are you finding this to be an advantage in kind of what we’re all living through now, or adding another layer of complexity you have to work around?
William F. Doyle – Executive Chairman
Yes. So Cory, I’m going to turn it over to Pritesh for further comment. But I do want to underline the point that from the very beginning of our commercial strategy development, we did not want to be in a position where we were selling through hospitals. And so we have a direct-to-patient model where we receive scripts. The hospital or the doctor’s office doesn’t have to maintain inventory. So you can imagine in this pandemic world where inventories have to be shipped, received, disinfected. We bypass all of that with our direct-to-patient business model, which I think clearly at the time we instituted for other reasons, but it’s clearly served us very well. And maybe with that, Pritesh, you can talk a little bit more about what we’re doing in the field.
Pritesh Shah – Chief Commercial Officer
Of course. Cory, thank you for that question. One of the core strengths that Optune has is that it’s a patient-administered therapy. And it fits well into the virtual clinic. And we’re hearing this sentiment resonate back to us or expressed back to us from physician advisors at advisory board meetings, as we’re helping them understand how we have pivoted the patient support model, continuing the live but also adding a virtual option. We’re asking for their feedback. And their feedback has been, hey, what you’re doing is resonating with patients, it’s working for patients. We’re not hearing from patients a disruption in the support that NovoCure provides. So, that gives us more confidence that the plans that we put in place are the right plans. And as Bill mentioned earlier, we’re going to continue to learn from these processes. And already we’ve made some adaptations as we’re learning on what works more effectively versus what our initial thoughts may have been. So we’re making minor tweaks along the way. But I do think that as more and more physicians are practicing telemedicine, their needs are such that they would like products that fit into the way that they’re practicing medicine. And we believe that we fit well into that model. So on that front, we’re learning more, but our early experience suggests that what we’ve done to date allows physicians to continue thinking about Optune in a positive manner for their patients.
Cory Kasimov – JPMorgan Chase & Co. — Analyst
Okay. And then I guess since people are asking so many questions this morning, I’ll ask a third. So back to the clinical trial front, and certainly recognizing the disruption of the pandemic, I’m still — I’m wondering if you can just talk about the level of physician enthusiasm to enroll patients in your ongoing non-GBM trials. Are you finding broad-based interest off the bat as you open a center, or is there a lot of heavy lifting trying to educate as it was in the early days of GBM?
I guess the bottom line here is I’m trying to understand if the delays that we’re still seeing to the clinical trials are purely a function of the disruption of COVID, or if there’s just other elements to the trial that you guys had to work around. Thank you.
William F. Doyle – Executive Chairman
Yes. So thanks, Cory. I’m going to turn it over to Ely, our Chief Medical Officer, and maybe he can talk a little bit about the clinician questions that you asked.
Ely Benaim – Chief Medical Officer
Hola. Buenos días. And thank you, Cory, for your call. I’d say that, to answer your question, this really depends on the trial. As you see, there is a lot of enthusiasm in the ovarian cancer, and I think it came — it was ramping up right before the COVID-19 and it just continues. But also I think PANOVA, we also have seen a lot of interest on all these trials. Remember that we believe that the acceptance of a novel technology requires really a significant physician education and behavioral change. And we have seen this play out very well in both the commercial and clinical setting. So, I would say there’s a lot of moving parts, and we really invested significant resources to enroll in all the ongoing trials.
I do think that the physicians in general, it depends geographically where they are situated, how the COVID-19 has affected. And it’s not even by country. It’s even regions, correct? You can see some difference in large academic centers that are very busy. But in the same city, there may be more of a community hospital that also sees this type of patient that have continued putting patients in trials. So I think I would say it depends, but the enthusiasm is there, and it depends on how busy these investigators are. We are — continue doing virtual SIDs, and we’re doing distant monitoring of the data. So we have continued pushing our clinical trials. And I think this will — if any, this all will get even better for us once this passes.
Cory Kasimov – JPMorgan Chase & Co. — Analyst
Okay. Excelente. Thanks for taking the questions.
Ely Benaim – Chief Medical Officer
Thanks Cory.
Operator
Thank you. Our next question comes from Greg Fraser with SunTrust. Your line is now open.
Gregory Fraser – Deutsche Bank AG — Analyst
Thank you. Buenos días. Thanks for taking the questions. It’s Greg Fraser on for Greg Gilbert. On Optune in the US, can you speak to the number of active prescribers that you have and whether that number is still growing? And is expanding the base of prescribers a priority?
William F. Doyle – Executive Chairman
Yes. So, we don’t give information about specific providers. What we do say and what we do know is that if you want to think of this in terms of market penetration, we think that we’re receiving scripts for about 40%, is the round number of the patients in the US, and that there is a significant continued opportunity for us to help patients. And that’s really our goal is to continue to educate, work with all potential prescribers.
We also believe at this point in the US, in Germany, in our key markets, Japan, that we have complete geographic coverage. So, it’s no longer an issue of greater penetration of clinicians in one part of the country versus another.
Gregory Fraser – Deutsche Bank AG — Analyst
Got it. And then sort of following up on the last question, I’m curious if the clinical trial sites are generally aligned with centers that have adopted TTF for GBM? And then on the LUNAR study, how many sites are you looking to add, and can you comment on where patient enrollment stands?
William F. Doyle – Executive Chairman
Yes. So, just quick answers. These are different clinician groups than — in large part, with the exception of METIS trial, compared to our GBM sites. Again, our GBM sites are virtually every site that sees GBM patients now in the US, so there’s not a big correlation there. I will say that the enthusiasm in the new communities does — is certainly benefited by all the progress that we made in GBM. And Ely described the enthusiasm of the new indications. They clearly don’t know much about TTF, just like when we started in GBM. This is completely new to these clinician groups, so we do have to do all the active education. And in answering your question specifically, we expect to add about 130 additional sites for this trial.
Gregory Fraser – Deutsche Bank AG — Analyst
Excelente. Thank you.
William F. Doyle – Executive Chairman
Pardon me. Not additional sites. I misspoke. Having 130 total sites to meet our timelines.
Operator
Thank you.
William F. Doyle – Executive Chairman
So it’s 130 total sites. Sorry, Greg.
Operator
Our next question comes from Jason Bednar with Piper Sandler. Your line is now open.
Jason Bednar – Piper Sandler & Co. — Analyst
Thank you. Good morning everyone. Thanks for taking the questions and for all the updates this morning. Bill, maybe going back briefly to the post-approval newly diagnosed GBM study you had mentioned in response to Difei’s question earlier, I know we’ll see the details when you post it, but is there anything you can talk about today with respect to maybe study size or expected lives? And then is there anything we should be mindful of with respect to the P&L once that trial launches?
William F. Doyle – Executive Chairman
Okay. So, I think there are two things. So with respect to the EF-19 clinical study, this was 192 patients in the active group compared to 117, who received the best standard of care. So this was not a launch of a study. This was the completion of a study. And this was kind of a low profile study because it was a confirmation study. But it was nonetheless excited about — exciting, once again, for us to see our ability to have yet another dataset. And maybe — Pritesh, I don’t know if you want to make a comment about the commercial impact of this study.
Jason Bednar – Piper Sandler & Co. — Analyst
And Bill, sorry. I don’t mean to interrupt, but the question was more about the newly diagnosed study that’s going to be launching here in combination with radiotherapy.
William F. Doyle – Executive Chairman
Okay. TRIDENT study, yes. So — again, this study has been designed. It is — sites have been signed up, and we’re currently just awaiting the first patient in.
Jason Bednar – Piper Sandler & Co. — Analyst
Okay. And then just I guess one other one for me. Maybe on a couple of your product pipeline items behind intensity [Phonetic] array and the new treatment planning, the Symmetry [Phonetic] software. Is there anything you can discuss there with respect to launch and roll-out timing? And maybe has COVID impacted your launch plans for either of those items?
William F. Doyle – Executive Chairman
Maybe I’ll let Asaf comment on the new products and where we stand. I know that our MyLink product is very much front of mind, but also the work that we’re doing with the novel arrays.
Operator
Thank you.
William F. Doyle – Executive Chairman
Asaf, I think you may be muted.
Asaf Danziger – Chief Executive Officer
Thank you for the questions, and sorry for being mute. So we do believe that there is a significant opportunity to improve Optune efficacy, and we are working on it. Our engineer is working on it for many years and we continue to work on it. We are not expecting any delay in our new development or the new launch of products. If at all, it’s the other way around. We are planning to basically to launch our MyLink sooner than we expected. So all in all, engineers are not affected by COVID in any way or shape. There are other engineering projects that are probably doing the other way around, that actually we’re going to launch them earlier.
Operator
Thank you. I’m not showing any further questions at this time. I would now like to turn the call back over to Bill Doyle for closing remarks.
William F. Doyle – Executive Chairman
So first of all, I want to thank everyone for their continued interest in NovoCure and our therapy. Our thoughts — I’ll start where Ashley started at the beginning. Our thoughts are with all of you. We know that everyone in almost every corner of the world is facing significant disruptions to their lives now, and we are with you during this time. Our focus has been on the continuity of care for our patients and the safety and health of our employees. I’m very proud that our team has made all of the progress that we’ve made and that we were able to announce today that we don’t expect any significant disruption in our business continuity. That’s really a tremendous achievement on the part of the team. And we don’t expect any change in the fundamental value proposition of the company. I think I’m going to leave it there. And again, thank you all for your interest in NovoCure.
Operator
[Operator Closing Remarks]Duration: 56 minutes
Call participants:
Ashley Cordova – Vice President of Finance & Investor Relations
William F. Doyle – Executive Chairman
Asaf Danziger – Chief Executive Officer
Wilco Groenhuysen – Chief Financial Officer
Pritesh Shah – Chief Commercial Officer
Ely Benaim – Chief Medical Officer
Unidentified Participant
Vijay Kumar – Evercore ISI Institutional Equities — Analyst
Difei Yang – Mizuho Securities USA LLC — Analyst
Esther Rajavelu – Oppenheimer & Co. Inc. — Analyst
Cory Kasimov – JPMorgan Chase & Co. — Analyst
Gregory Fraser – Deutsche Bank AG — Analyst
Jason Bednar – Piper Sandler & Co. — Analyst
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