NovoCure Limited (NVCR) Q1 2020 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by and welcome to the Novocure First Quarter 2020 Earnings Conference Call. [Operator Instructions] I would now like to turn the conference to your speaker today, Ashley Cordova, Senior Vice President of Finance & Investor Relations. Please go ahead, ma'am.

Good morning, everyone and thank you for joining us to review Novocure's first quarter 2020 performance. On behalf of the entire Novocure team, we would like to begin by wishing you well as we collectively face the challenges of the COVID-19 pandemic. We hope that you and your loved ones are staying healthy and safe during this unprecedented time. With safety in mind, we are conducting today’s call virtually. I am joined on the phone by our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; and our CFO, Wilco Groenhuysen. Pritesh Shah, our Chief Commercial Officer; and Ely Benaim, our Chief Medical Officer are also on the call and available for Q&A. This morning first we will focus on our response to COVID-19. And then we will provide our standard updates on our first quarter performance. The slides presented today can be viewed on our website www.novocure.com by clicking on the link for first quarter 2020 financial results located in the Events section on our Investor Relations page. Before we start, I would like to remind you that our discussions during this conference call will include forward-looking statements and actual results could differ materially from those projected in these statements. These statements involve a number of risks and uncertainties some of which are beyond our control including those risks and uncertainties described from time to time in our SEC filings. We do not intend to update publicly any forward-looking statement except as required by law. Following our prepared remarks today we will open the line for questions. Financials for the 3 months ended March 31, 2020 are available on our press release and in our 10-Q, both of which we released earlier this morning. Where appropriate, 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 appendix of the supplemental slides accompanying this presentation and in our Form 8-K filed with the SEC today. These materials can be accessed from the Investor Relations page of our website, www.novocure.com. With that, I will now turn the call over to Bill Doyle.

Thank you, Ashley and good morning everyone. While the last 2 months have been unprecedented as we adapt to the realities of the global COVID-19 pandemic, we believe the fundamental prospects for our business are unchanged. That said, we have had to adjust the way we conduct business to adapt to the evolving COVID-19 situation. We have implemented measures across our organization to continue delivering Tumor Treating Fields therapy to patients while protecting the Novocure community around the world. 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 operation centers remain open, but we have segregated these centers into zones to minimize person-to-person contact. We are monitoring the elements of our global supply chain in an effort to ensure we maintain adequate inventories of all key products. Our field-based patient support teams continue to conduct in-person visits when appropriate and to leverage technology to serve our patients virtually. Our award winning nCompass team continues to provide on-call phone and e-mail support 24 hours a day, 7 days a week. We continue to treat current clinical trial patients and to enroll new patients at existing clinical trial sites in our six ongoing clinical trials. Notwithstanding these efforts, clinical trial enrollment has been adversely impacted by COVID-19, specifically clinical trial site expansion has been and we believe will continue to be materially delayed as sites devote significant resources to COVID-19. We believe the value of the Tumor Treating Fields platform, the resiliency of our direct-to-patient business model, and the long-term potential of our business remain intact. Over the last 20 years, we have built an organization of 850 colleagues dedicated to delivering Tumor Treating Fields, our life-extending therapy to patients with glioblastoma or mesothelioma, and dedicated to performing clinical and product development programs intended 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 passed a number of important milestones in the first quarter with more than $100 million in net revenues, more than 3,000 active patients on therapy, and more than 500 million covered lives globally. Our financial strength allows us to continue investing in innovation, and we believe it positions us well to navigate through the substantial uncertainty affecting our industry. The need to treat patients with aggressive cancers does not lessen with COVID-19, and we are confident in our team, our strategy, and the fundamental value proposition of the Tumor Treating Fields platform. I'll share more details on our clinical pipeline later on in this morning's call. But first, I'll turn the call over to Asaf to share his perspective on the quarter and recent events. Asaf?

Thank you, Bill. In Q1 2020 Novocure delivered another strong quarter of top line growth with a record $102 million in global net revenues, up 39% versus Q1 2019. Our net revenue growth was driven by continued active patient growth and by expanding reimbursement for Optune. We ended the first quarter with 3,095 active patients on therapy, representing an 18% year-over-year increase and 6% sequential quarterly increase. Prescription volume also grew. We received 1,409 total prescriptions in Q1, and the mix of newly-diagnosed GBM prescriptions remained near 80%. We believe our Q1 performance highlights our team's ingenuity and commitment to serving our patients and their families. COVID-19 is changing how we interact with healthcare providers, but our customer engagement teams remain focused and in execution mode. We are respecting all institutional restrictions on external visitors at the cancer centers, hospitals, and research institutions we serve. While this has resulted in decreased in-person connections, in many instances it is creating new opportunities to engage customers. We were quick to develop multiple virtual engagement tools to connect with healthcare professionals and to enable information sharing. To give some examples, we recently launched a 4-part TTFields webcast series on utilizing telemedicine, delivering treatment in an outpatient setting and managing Optune treatment remotely. We just conducted the second part of the series on Tuesday evening to connect with both GBM and MPM physicians, many of whom face competing priorities limiting their availability. We continue to host virtual speaker programs and highlight the benefits of home-based treatments, particularly for vulnerable patient population. Our medical affairs team will lead a roundtable discussion plan to define new clinical guidelines for managing patient care in these challenging times. We have also setup virtual chat capability for our patient ambassadors who are available resource to patients, caregivers, and physicians. Maintaining access to this program is an important way to wave [ph] the Optune patient experience into the dialogue between healthcare provider teams and patients diagnosed with GBM or MPM. Beyond our sales and marketing efforts, we continue to advance our product development program intended to improve efficacy and patient usability. In response to social distancing related to COVID-19, we are currently evaluating accelerated regulatory approval options to launch our MyLink [ph] remote download capabilities sooner than 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 to ensure a coordinated response across our global sites. The situation is challenging for us all, but I can assure you we are as focused as ever on driving the commercialization and development of TTFields. With that, I will turn the call back over to Bill to share some data on our clinical trials.

Thank you, Asaf. We believe the Tumor Treating Fields mechanism of action is broadly applicable to solid tumor cancers. Our scientific research spans two decades and then all of our preclinical and clinical research to date, Tumor Treating Fields has demonstrated a consistent anti cancer effect. Results from EF-19, our latest clinical trial dataset were presented earlier this week at the American Association for Cancer Research 2020 Virtual Annual Meeting One. The EF-19 study was mandated by the FDA to confirm the efficacy of Tumor Treating 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 a 192 patients compared to the 117 recurrent GBM patients who received best standard of care chemotherapy in Novocure's EF-11 registration trial. In EF-19, Optune monotherapy reduce the risk of death with fewer adverse events compared to best standard of care chemotherapy. For patients who received at least one course of therapy, Optune prolong survival by a median 1.7 months. No new safety signals were noted. The EF-19 data confirm the effectiveness and safety of Optune and further strengthen Optune's clinical profile in the GBM indication. Our extensive preclinical and clinical evidence provide the foundation upon which we are executing a strategy to advance Tumor Treating Field through additional clinical research studies across multiple solid tumor types. We are currently conducting six clinical programs evaluating the use of Tumor Treating Fields, including four randomized Phase 3 pivotal trials. And that is trial and 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. Entering the quarter, our patient enrollment projections for LUNAR and PANOVA-3 relied on increases in the number of clinical trial sites to accelerate enrollment. As we engage METIS investigators throughout the quarter, we also initiated plans to expand the study footprint into additional countries to accelerate enrollment. The clinical trials site expansions have been materially delayed as sites devote significant resources to COVID-19. While we continue to evaluate initiation of new clinical trial sites using a risk based framework in accordance with local regulations and site policies, we were able to on-board only two new sites for these trials in March. We continue to work closely with institutions, local authorities and contract research organizations to maintain engagement and to refine our processes in order to advance our clinical research studies. We have implemented virtual site initiation visits and have developed remote monitoring capabilities. Notwithstanding these efforts, we expect challenges with clinical site initiation and patient enrollment to continue at least through the second quarter. As a result of these delays, we now project final data from METIS in 2022. Additionally, we now anticipate final data from both the LUNAR and PANOVA-3 trials will be available in 2023 with planned enrollment driven interim analysis in 2021. These projections are based on our current phase of enrollment as well as the anticipated impact of the COVID-19 pandemic on global health care systems. The European network for gynecological, oncological trial groups, and the GOG Foundation third-party clinical trial networks are collaborating with us on our INNOVATE-3 Phase 3 pivotal trial and facilitating enrollment as leading cancer centers. Notwithstanding delays in clinical trial site expansion related to the COVID-19 global pandemic, INNOVATE-3 patient enrollment trends continue to outpace our expectations in the first quarter, driving an acceleration in our anticipated enrollment timeline. We now expect final data from INNOVATE-3 in 2023 with an enrollment driven interim analysis in 2021. We remain optimistic about the potential to significantly expand the addressable market for Tumor Treating Fields with readouts of key data sets anticipated over the next 3 years. We will continue to provide updates in the future as we gain clarity regarding the duration of COVID-19s impact on the clinical trial environment. With that, I'll turn the call over to Wilco to discuss our financial results.

Thank you, Bill. Novocure ended the first quarter in a strong financial position. We continue to make progress in developing our commercial business, delivering first quarter net revenues of $102 million, representing 39% growth versus the first quarter of 2019. An year-over-year revenue growth was driven both by an 18% increase in active patients and by a 15% improvement in average net revenues booked per active patient. The increase in revenue per patient benefited from improving reimbursement rates, particularly in the United States. Access to our therapy continues to grow in our active markets, which we believe demonstrates an increasing recognition by health insurers of the value of Tumor Treating Fields. In March, the German Federal Joint Committee, or G-BA established national reimbursement for Optune in newly-diagnosed GBM, following a comprehensive benefit assessment. We consider further expansion of reimbursement in our currently active markets, an important lever for continued revenue growth. Specifically, we recognized $7 million in first quarter net revenues for Medicare beneficiaries built under the positive coverage policy. We are working for the typical administrative ramp up with Medicare and expect our net revenues from Medicare beneficiaries to further improve as we gain experience processing claims. At the end of the quarter, half of our Medicare active patients started treatment after September 1, 2019, the effective date of the Medicare coverage policy. Moving down to P&L, gross profit in the first quarter was $77 million, reflecting a 76% gross margin. Our capital allocation priorities are 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, up 48% versus the first quarter of 2019, reflecting our ongoing commitment to investments in clinical and product development intended to extend survival in multiple solid tumor cancers. We anticipate R&D expenses will continue to increase in future quarters as we advance these development programs. Our first quarter SG&A expenses were $55 million, up 30% versus the first quarter of 2019, driven primarily by an increase in marketing expenses related to the launch of Optune Novo and 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 net operating loss carry backs in the U.S. pursuant to changes in the U.S. tax code, enacted in response to the economic impacts of COVID-19. Our net income was $4 million with $0.04 in earnings per share, a third consecutive quarter of positive net income. We also reevaluate our operating performance based on adjusted EBITDA, a non-GAAP measurement of earnings before interest, taxes, depreciation, amortization and share-based compensation. Adjusted EBITDA increased by $10 million, or 176% to $15 million for the 3 months ended March 31, 2020 from $5 million for the 3 months ended March 31, 2019. This improvement in fundamental financial performance was driven by top 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 prior quarter. We remain committed to improving financial, operational and capital efficiency by maintaining a balanced focus across growth, profitability and liquidity. Before I hand the call over to the operator for Q&A, I would like to thank everyone on the phone for their continued interest in Novocure. The aggressive cancers that we treat do not slow because of COVID-19 and we remain as focused as ever on delivering our therapy to the patients who rely on us. Innovation is one of Novocure's [indiscernible] values, and this innovation is tangible as we adapt in real-time to ensure patients have access to the therapy and support, they need. We continue to monitor the potential impacts of COVID-19 and will adept our plans as needed to mitigate potential risks as we gain new knowledge. Our first quarter performance highlights the track record of execution with progress across the commercial business and continued financial strength. We believe that the fundamental prospects of our business are unchanged and our focus is unwavering on strengthening our existing foundation and advancing clinical and product development programs intended to unlock future value. Thank you for your time this morning. With that, I will turn the call over to the operator for questions.

Thank you. [Operator Instructions] Our first question comes from Larry Biegelsen with Wells Fargo. Your line is now open.

Hi, everyone. Thanks for taking the questions. This is Kevin on for Larry this morning. My first one is just looking at the total TRx. It came in better than expected in Q1. And now understanding the fundamental need to treat aggressive cancers does not lessen with COVID-19, as you mentioned, I'm just curious if you could parse out how the growth was trending in January/February versus the last two weeks of March as exit growth rate. If you could provide any color by geography too, it would be helpful. I'm also curious if you could just frame up your thoughts on Rx growth you're seeing in April thus far, if you can share it. Is it roughly the same or is it fair to assume it's worse than the March rate? And then I just have one follow-up. Thank you.

Yes. Good morning, Kevin. This is Bill. As Ashley mentioned at the top of the call, we are all remote literally in different spots around the world. So, I'm going to be a little more directive in the Q&A than typical because we're not all in the same room. Pritesh, maybe it makes sense for you to comment on Kevin's questions related to TRx’s and trends.

Sure. Kevin, thank you for the question. So, in the first quarter, something that was important from a milestone standpoint is that we passed in Q1 more than $100 million in net revenues, over 3,000 activate patients, and more than 500 million lives covered. This further strengthens our core capabilities as a commercial organization to continue to treat more patients with GBM and MPM. With that, we also received more than 1,400 prescriptions in Q1 2020, representing a 2% sequential growth and 8% year-over-year growth. We don't parse out sort of what's happening kind of month-by-month. We shared in aggregate, and one of the things that we shared with you in the opening comments is that we saw no material change in our commercial business in Q1. And based on what we know today, we do not anticipate a material impact on our commercial business moving forward. Now that’s realizing we're -- we just finished the a third of the second quarter. So, that's based on what we're seeing today. This is what we can share with you.

Perfect. That’s helpful. And then just my follow-up is on the clinical update. You have three interim analyses of Phase 3 trials coming in 2021. Do you have a sense of the cadence from a timing standpoint of when each of those may hit next year? Thanks so much.

Yes. So, I think one of the things that's important to understand is that when we initiate a trial, we project a recruitment goal. We have a number of levers that we pull during the trial, including site engagement and site expansion. We don't today project the specific order of those trials. We will provide additional detail as we enter 2021 and the situation with COVID-19 and the situation of the trial sites becomes clear.

Okay. Thank you. That’s helpful. Actually, if I could sneak one more in. I was just curious on this. You're seeing COVID impact new patient starts as you had mentioned. Does it impact active patients as well? In other words, should we expect a death in active patients in Q2, in addition to new patients starts? Any trends and behaviors different in the U.S by geography there? Thanks so much.

Yes. So this -- Kevin, this is a very important point to make, which is when we talked to some of our other colleagues in the MedTech arena, they -- there's clearly been dramatic impacts because even unbelievably heart surgeries are being considered optional surgery and being postponed at this point. Our patients with these extremely aggressive cancers are remaining on therapy. And we remain -- we've made real-time adjustments in the way that we interact with our patients and caregivers. And so, we don't see any interruption in our ability to treat our patients on therapy, and that includes our commercial patients and our clinical trial patients. And we are maintaining patient starts. So, I think that's an important point to mention, too, so just complementing or building on what Pritesh said, we don't expect to see a change in our commercial business as a result of COVID-19.

Perfect. Thanks for taking the questions, guys.

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

Hey, guys. Thanks for taking my question. So, Bill, maybe one on the clinical trial timelines out there. Interestingly, so we had some push outs, but we also had some pull forwards. If we dig into it, I think the press release had LUNAR as number 3 in your bullet points, I don't know if that's an indication of timeline first half versus second half of '21. And on the ovarian side, the pull forward, why do you think the enrollment is going faster? Is this perhaps because it's a more global trial versus LUNAR? So any comments I think would be helpful.

Yes. Good morning, Vijay. So first of all, let me be clear. The order in the press release has no bearing on projected timeline. And as I said previously, when we start these trials, we make certain assumptions, certain projections, and we have certain levers that we pull during the trial. So, you highlight a perfect example of sometimes our projections are overestimates and sometimes they’re underestimates. As the trials progress, we begin to get more clarity onto the details of the timing. We -- in normal times have things that we adjust. And again, we mentioned site engagement and number of sites, and that is what we have been clearly thrown the curveball with COVID-19. But in this case, as you stated, INNOVATE is in fact moving ahead of the initial projection.

Got you. And one on script volumes, if I may. Is it a fair statement to assume that, April -- there is some impact just given your patient's ability to visit their physicians, treating physicians. And if that's the case, once the lockdowns were lifted, is there any lag in [indiscernible] channel kicks in. I would assume just given this is cancer, the comeback should be really, really good. Thank you.

Yes. Vijay, I'll just repeat what Pritesh said earlier just to emphasize this. Unlike many or most MedTech businesses, the need to treat patients with aggressive cancers has not been affected with COVID-19. And based on what we know today, we don't anticipate a material impact to our commercial business going forward.

That's extremely helpful. Thanks, guys.

Thank you. Our next question comes from Difei Yang with Mizuho. Your line is now open.

Hi. Good morning. Thanks for taking my questions. Congrats on the great first quarter. So a couple questions. Would you give us a little bit more information with regards to what are you doing differently post-COVID to get patients started? [Indiscernible] new patient start is phenomenal. It's very impressive. I'm just curious what are the sequence of events you did to keep that? And then secondarily, if you could give us update on what's happening with the GBM approval in China. Are they back to work?

Sure. So good morning, Difei. And thanks for the congratulations and thanks for your questions. I'm going to turn the call to Pritesh to answer the questions about what we're doing differently. But I do want to congratulate our teams for moving extremely quickly to implement changes and Pritesh maybe you can describe some of the specific things that we're doing.

Sure. Thank you, Bill, and thank you for the question. I'm actually extremely proud of how quickly we've adapted. And in our adaptation, a few things were leading us to take the steps that we've taken. First and foremost, we wanted to ensure safety. And second, we wanted to ensure continuity of care as patients were being treated for GBM and MPM. So in the very early days of COVID exposure, we wanted to make sure that we had options for clinicians who wanted to treat patients with Optune. And one of those options included virtual starts. And this required our teams to leverage technology to support patients across our active markets in accordance with local regulations, because we were also up against different regions and different provinces having different sets of regulations. So one way that we were able to achieve this, for example, is using the go to meeting platform with patients. We had our first virtual start in Hawaii, for example, where it's not quite remote, but definitely isolated from mainland in the U.S. So that gave us some experience which allowed us to then adapt to other starts that we've conducted in the virtual setting. So we continue to offer today two opportunities for patients to start treatment. One is to ensure that they can leverage this virtual platform. The second is we are still conducting live starts with full personal protective equipment. So these sort of two options are allowing us to pivot to the needs of the care team, as well as patients. On the health care provider front, we're also making sure that they have the education that they need and the resources and the tools they need to support patients. On this front, we’re also engaging virtually and making sure that we're offering them opportunities to see and feel the support that we're providing. And then finally, our nCompass team remains available for the providers as well as for patients. And this is our team of individuals who are supporting patients and providers over the phone virtually as well as live over the telephone. So these are some ways that we've adapted and ensured that we're ensuring continuity of care for patients who really need our treatment.

Thanks, Pritesh. And, Difei, with respect to Zai, I will say our partnership with Zai is stronger than ever. And in addition to the work in GBM, they are -- I'll remind everyone, they are our clinical partners and we have an open trial in gastric cancer now open in Hong Kong. With respect to the potential GBM approval in Mainland China, Zai sentiment has not changed and they're actively preparing for commercial operations for a launch in China in the near-term.

Thank you, Bill. A question -- just a follow-up with regards to the EF-19 study. So how would you plan to elaborate the outcome of that study, in addition to just in compliance with the regulatory requirements?

So thanks for the question. So, this was a trial when our -- when we received our first PMA approval based on our EF-11 trial results in recurrent GBM. I'll remind everyone, since it was a long time ago, that was a trial that compared up to monotherapy to best standard of care chemotherapy. So it was not -- Optune was not used in combination with chemotherapy, it was used as a monotherapy. When those data were presented and approved, it was the first time that the FDA had dealt with Optune and so they've requested or I shouldn't say requested, they mandated that we do a post approval trial. That post approval trial, as described in the press release earlier this week, read out at AACR annual meeting and we were very pleased because in this case the data showed superiority in the real life setting to the clinical trial controls. In general we think this data confirms the effectiveness and safety of Optune and strengthens our clinical profile overall. Of course, our focus has moved now to newly-diagnosed GBM. We think that's in combination with chemotherapy. We think that's where patients derive the most benefit. But this is just yet another confirmation of the value of Optune therapy for GBM patients.

Yes. Thank you, Bill. And if I may, just the last question. Do you expect to do a similar study for newly-diagnosed GBM?

The FDA did not mandate a follow-up study in newly-diagnosed GBM. The next study that we have planned in newly-diagnosed GBM is the Trident [ph] study, which would describe -- which will evaluate using Optune with radiation compared to using Optune after radiation. And we expect that trial to begin enrollment shortly and we'll press release the first patient in on that study.

Thank you, Bill.

Thank you. Our next question comes from Esther Rajavelu with Oppenheimer. Your line is now open.

Good morning and thank you for taking my questions. Just a couple from me. First, for the U.S market, can you give us some color on the Medicare patients split in your active patients and your -- and in your new scrip numbers?

Sure. 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 U.S.

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 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 that we mentioned it on the script, is that we are making considerable progress in recognizing revenue for the Medicare population, that is directly correlated with the number of active patients [indiscernible] 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.

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 situation. So can you maybe compare the impact in your trial enrollment and generally in your timeline versus some of the other oncology trials that may be ongoing?

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, etcetera. 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.

Okay. So I guess, would it be accurate 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 on boarding new sites that's affecting the timeline?

It's 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.

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 -- are those -- do you view those as temporary or with some of those essentially be permanent changes as you think about maybe views on driving efficiencies?

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 the -- 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 or are 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 there are 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.

Great. Thank you so much. Congrats.

Thank you. Our next question comes from Cory Kasimov with JPMorgan. Your line is now open.

Hey, good morning, guys. Thanks for taking my questions. I guess, first of all, on LUNAR, given how this treatment landscapes 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’ve a follow-up.

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 it's 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 adaptivity or synergism. So we expect that this will be used with whatever emergence 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.

Okay. And then I wanted to follow-up on some of the earlier questions on your patient interactions. I mean, Optune TTFs, 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 nurse doing it in office. So here 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?

Yes. So, Cory, I’m going to turn it over to Pritesh to -- 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, but 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 is 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.

Sure. 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 express back to us from physician advisers at advisory board meetings as we're helping them understand how we have pivoted the patient support model continuing to lie, 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 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.

Okay. And then I guess since people are asking so many questions this morning, I will 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 interests of the [indiscernible] 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 have to work around? Thanks.

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.

Hi. Good morning and thank you, Cory, for your call. I would say that I will -- to answer the 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 continue. But also I think Novo [ph] we also have seen a lot of interest on the -- on all these trials. Remember that, we believe that the acceptance of novel technology requires really 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’ve really invested in significant resources to enroll [indiscernible] 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 countries or even regions, correct. You can see some differences in larger academic centers are very busy. But in the same city, there may be more of a community hospital that also sees this type of patients that have continue putting patients in trials. So I think I will say it depends. But the enthusiasm is there and it depends of how busy these investigators are. We are continue doing virtual SIBs and we're doing -- this been the monitoring of the data. So we have continue pushing our clinical trials. And I think this will, if any, this all will get even better for us once this passes.

Okay, great. Thanks for taking the questions.

Thanks, Cory.

Thank you. Our next question comes from Greg Fraser with SunTrust. Your line is now open.

Thanks. Good morning. Thanks for taking the questions. It is Greg Fraser on for Gregg Gilbert. On Optune in the U.S., 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 of priority?

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 U.S 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 U.S. and Germany and 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.

Got it. And then sort of following up on the last question, I'm curious that 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 has been?

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 U.S. 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 we describe 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 questions specifically, we expect to add about 130 additional sites for this trial.

Great. Thank you.

Pardon me. Not additional sites, I misspoke. Having 130 total sites to meet our timelines.

Thank you.

That’s a 130 total sites. Sorry, Greg.

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

Thanks. 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 mentioned in response to Difei's question earlier. I know we'll see the details when you posted, but is there anything you can talk about today with respect to maybe study size or expected blights? And then is there anything we should be mindful of with respect to the P&L once that trial launches?

Okay. So I think there are two things. So with respect to the EF-19 clinical study, this was one 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 data set. And maybe, Pritesh, I don't know if you want to make a comment about the commercial impact of the study.

Bill, sorry, just -- 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.

Okay. Private study. Yes. So, again, this study has been designed. It is -- sites have had been signed up and we're currently just awaiting the first patient in.

Okay. And then just, I guess one other one for me. Maybe on a couple of your product pipeline items, the [indiscernible] array and the new treatment playing the symmetry software. Is there anything you can discuss there with respect to launch or rollout timing and maybe has COVID impacted your launch plans for either of those items?

Maybe I'll let Asaf comment on the new products and where we stand. I know that our MyLink [ph] product is very much front of mind, but also the work that we're doing with the [indiscernible].

Thank you.

Asaf, I think you may be muted.

Thank you for the questions. And sorry for being mute. So we do believe that it's a significant opportunity to improve Optune efficacy and we are working on it. Our engineer is working on it for many years and we will continue to [indiscernible]. We are not expecting any delay in our new development or the new launch of products, if at all it gather around, we are planning to basically to launch our MyLink [ph] sooner than we expected. So all in all, engineering are not affected by COVID in any way or shape. There are other engineering reported that [indiscernible] around that actually we are going to launch them earlier.

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.

So, first of all, I want to thank everyone for their continued interest in Novocure and our therapy. Our thoughts -- I'll start were Ashley start 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.

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