Earnings Call Transcript - NVCR Q3 2021

Operator, Operator

Good day, everyone, and welcome to Novocure's Third Quarter 2021 Earnings Conference Call. All participant lines are currently in a listen-only mode. We will have a question-and-answer session later, and instructions will be provided at that time. This call is being recorded. I would now like to hand the call over to your host today, Ingrid Goldberg, Vice President of Finance and Investor Relations. Please proceed.

Ingrid Goldberg, Vice President of Finance and Investor Relations

Good morning, everyone, and thank you for joining us to review Novocure’s third quarter 2021 performance. I’m joined on the phone by our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; and our CFO, Ashley Cordova. Other members of the executive leadership team are also on the call and available for Q&A. The slides presented today can be viewed on our website, www.Novocure.com, by clicking on the link for the Third Quarter 2021 Financial Results located in the Events section of 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 your questions. Financials for the 3 and 9 months ended September 30, 2021, are available in our press release and in our 10-Q, both of which we released earlier this morning. Where appropriate, we 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 in the appendix of the supplemental slides accompanying this presentation and in our Form 8-K filed with the SEC today. These materials can also be accessed from our Investor Relations page of our website. With that, I will now turn the call over to our Executive Chairman, Bill Doyle.

Bill Doyle, Executive Chairman

Thank you, Ingrid, and good morning, everyone. At Novocure, we are focused on our mission to extend survival in some of the most aggressive forms of cancer. Tumor Treating Fields as a platform therapy and the totality of 20-plus years of scientific research supports our belief that we can safely use Tumor Treating Fields with the evolving standards of care in a multitude of cancer indications. We also have numerous opportunities to explore improving our therapy to further enhance efficacy and ease-of-use for our patients and caregivers. Our clinical trial pipeline is robust and continues to grow with organic research opportunities yet to be explored. We have an extensive intellectual property portfolio that we are consistently expanding and will rigorously defend. Since our founding over 20 years ago, we have established a cancer therapy business model that is unique, expandable, and repeatable. Our international GBM business is cash generative and is supporting the significant investments we are making to generate future growth. With multiple late-stage trials set to read out in the next 24 months, we believe Novocure is approaching a key inflection point for patients and our organization. As we close in on these milestones and with the stability provided by over $900 million in cash on hand, we are aggressively investing in our pipeline and product development efforts to bring our novel therapy to many more patients in need. In summary, the fundamentals of our business are strong, and we are energized by the opportunities before us to help many more cancer patients and to grow our Company. Before we discuss our quarterly results, I would like to announce that we have enrolled the last patient in our Phase 3 pivotal INNOVATE-3 trial for the treatment of platinum-resistant ovarian cancer. This is a major step forward for our clinical trial program and is an important achievement for all of those involved. Asaf will provide more detail on the next steps, momentarily. In today’s call, first, we will discuss updates from the quarter in our core GBM business. We will then turn to our recent clinical development progress. Finally, we will underline the financial power and flexibility afforded by our sustainable business model. Our GBM business continues to fuel our aggressive investment in future growth initiatives. This quarter, we generated $133.6 million in global revenue and ended the quarter with over 3,500 active patients on therapy. We invested $48 million in research and development, bringing our total investment in R&D during the first three quarters of the year to $144 million, nearly 10% more than the total amount invested in all of 2020. Our GBM growth strategy focuses on broadening our eligible patient population through the expansion of our geographic footprint and label as well as increasing penetration in our current markets. We believe further engagement with key academic centers is paramount to our penetration efforts. We have identified academic centers that see a sizable portion of the GBM population where we are under-penetrated. We are pursuing opportunities to increase and expand touchpoints with these centers. Our teams have opened multiple clinical trials at key academic centers, with several site initiations scheduled. Also, we have launched multiple investigator-sponsored trials such as Dr. Soltys’ study at Stanford University, examining the effects of hypofractionated chemoradiation plus TTFields. Both our clinical trials and investigator-sponsored trials offer unique opportunities for academic practitioners to experience hands-on use of TTFields in their patient population. I would be remiss if I did not mention the ongoing impacts of the pandemic on our commercial business. Broadly, we have seen COVID-19 reduce cancer patient engagement with physicians, delay surgeries, and stress hospital staffing at all levels, all of which can affect the patients starting Optune at the ideal time. Policies adopted by hospitals to prevent infections and manage COVID-19 caseloads have reduced our ability to interact with some oncologists. These challenges wrought by the pandemic ebb and flow regionally with COVID case volumes. We are monitoring these situations daily and doing everything in our power to be nimble and innovative to provide TTFields therapy to all the patients who may benefit from it. Outside of GBM, we announced several notable achievements this quarter. In September, we announced a new clinical collaboration with Roche to co-design a single-arm trial to study the use of Tumor Treating Fields together with the anti-PD-L1 therapy atezolizumab for the first-line treatment of metastatic pancreatic ductal cancer. Preclinical data suggests TTFields together with immune checkpoint inhibitors can result in increased tumor control. Up until now, the immune-shielded environment of the pancreas has proved to be difficult for immunotherapy agents to penetrate, and multiple clinical trials have failed in this high unmet need indication. We believe the use of Tumor Treating Fields in atezolizumab may finally make an impact for patients diagnosed with pancreatic cancer. We are extremely excited to begin our work with another global oncology leader. Also this quarter, the FDA granted breakthrough device designation for the NovoTTF-200T system for the treatment of advanced liver cancer. As we look ahead to a future Phase 3 trial in liver cancer, breakthrough device designation offers the opportunity to interact directly with FDA experts through the premarket review process and allows for prioritized review of regulatory submissions. We also announced the final patient enrollment in our EF-31 single-arm trial, studying the treatment of gastric cancer together with our partner, Zai Lab. As a reminder, gastric cancer is the third most common cancer in China and has a poor prognosis with a median overall survival rate of approximately one year. Now that EF-31 has completed enrollment, we look forward to beginning the data analysis process and are on track to release data in 2022. Finally, we recently celebrated a milestone internally that I’d like to share with you. Daniel Torres was the first patient in the U.S. to enroll in our Phase 3 EF-11 GBM trial 15 years ago. This summer, Daniel celebrated his 66th birthday with his wife and four children in Chicago. Daniel’s milestone is a strong reminder to everyone at Novocure of why our efforts are so important. We are working to extend survival for patients diagnosed with some of the most aggressive forms of cancer. So, patients like Daniel can celebrate more milestones with their loved ones. I would personally like to thank Daniel for being a wonderful ambassador for our company and an inspiration to the Novocure team. With that, I will now pass the call over to Asaf, who will discuss our pipeline updates.

Asaf Danziger, CEO

Thank you, Bill. First, I would like to take a moment to congratulate and thank the Novocure team for another strong performance this quarter. I appreciate your tireless dedication to our mission. As Bill mentioned, we are nearing a potential inflection point with several of our late-stage clinical trials expected to read out in the near term. As a reminder, we currently have five large randomized trials ongoing, INNOVATE-3, LUNAR, METIS, PANOVA-3, and TRIDENT. I will begin with an update on our INNOVATE-3 trial in recurrent ovarian cancer, which has now completed enrollment. Together with our partner, ENGOT and The GOG Foundation, INNOVATE-3 is the largest abdominal trial to complete enrollment in the history of Novocure, an immense achievement for our team. The next step will be the Independent Data Monitoring Committee’s review of the statistical analysis plan and the prespecified interim analysis. Final data will be collected following an 18-month follow-up period. Ovarian cancer is the fifth leading cause of cancer deaths in women, and we are hopeful that the data from this trial will present the next step in addressing this deadly disease. Our LUNAR trial in non-small cell lung cancer is on track to enroll its final patient this year. Nearly 200,000 patients are diagnosed with non-small cell lung cancer in the U.S. alone each year. As a reminder, following FDA approval of an IDE supplement, incorporating the recommendations from the Independent Data Monitoring Committee earlier this year, the LUNAR trial will now enroll 276 patients with a 12-month follow-up period prior to data collection. Enrollment continues in our METIS trial, studying TTFields for the treatment of brain metastases from non-small cell lung cancer. As a secondary tumor shielded by the blood-brain barrier, the standard-of-care for the treatment of brain metastases has not improved significantly beyond stereotactic radiosurgery. We believe this is a unique opportunity to study the effect of our therapy on non-small cell lung cancer in a region of the body we have proven we can impact. We anticipate final data in our METIS trial to be collected in 2023. While our INNOVATE, LUNAR, and METIS trials are enrolling well and remain on track, the PANOVA-3 trial has been impacted by logistical constraints. PANOVA-3 is studying the use of TTFields together with gemcitabine and nab-paclitaxel, also commercially known as ABRAXANE, in patients with unresectable locally advanced pancreatic cancer. As you may know, there is a global supply chain shortage of ABRAXANE. We are working with our clinical sites to understand supply levels, but recognize that some sites have been impacted. Additionally, the Chinese import license required for ABRAXANE was denied by the Chinese governing body. We recognize these constraints will impact the enrollment timeline for the PANOVA-3 trial and now anticipate final data in 2024. To be clear, this does not alter our excitement around the PANOVA-3 clinical trial or the unmet need for those suffering from pancreatic cancer. We continue to believe we can positively impact patients diagnosed with this deadly disease. Moving beyond our late-stage pipeline, I would like to highlight an exciting presentation at next month’s Annual Society for Neuro-Oncology Medical Conference or SNO. Dr. David Tran from the University of Florida will present updated data from the 2-THE-TOP investigator-sponsored trial. 2-THE-TOP is a single-arm trial studying the impact of TTFields together with immunotherapy for the treatment of newly diagnosed GBM. In 2-THE-TOP, following standard chemoradiation, patients concurrently receive TTFields, temozolomide, and pembrolizumab. Dr. Tran’s research is an important continuation of our exploration of synergies between TTFields and immunotherapy agents and is the first such trial in newly diagnosed GBM. Preliminary data shared at our R&D Day last year were very encouraging, and we are eager to share the final data from Dr. Tran’s study. Before passing the call to Ashley, I would like to reiterate my congratulations to the Novocure team. When I look at all we have accomplished as a team over the past 20 years, it gives me confidence that this is only just the beginning for Novocure. I cannot wait to see what we can accomplish together over the next 20 years.

Ashley Cordova, CFO

Thank you, Asaf. Novocure completed the third quarter in a strong financial position. Our core GBM business generated $133.6 million in net revenues in the quarter, bringing our year-to-date revenue to $402 million, an increase of 15% versus the first three quarters of 2020. Additionally, active patients on therapy grew to 3,502, representing a 4% year-over-year increase. We have continued to see increased traction with our partner in China, Zai Lab, now in its sixth quarter of commercializing Optune for the treatment of GBM. Included in our net revenues is $10.6 million in revenues from Medicare fee-for-service beneficiaries in the quarter. We believe we have completed our administrative ramp-up for processing Medicare claims and efficiently pursuing appeals. This is a meaningful milestone in our operational evolution. While we are through the administrative ramp-up for patients who started therapy post coverage, it is important to note that nearly 25% of our current Medicare patients began therapy prior to our effective coverage date in September 2019, and as a result, are not contributing revenue at the time of billing. I would like to take a moment to highlight what this means for our patients clinically. This is an incredible feat in that TTFields has contributed to the continued survival of this patient cohort for more than two years. It also represents additional upside over time as the Medicare patient mix shifts to include a greater percentage of patients who started therapy after September 2019. I would also like to highlight that we did not recognize any revenue from our Medicare backlog in the third quarter of 2021 versus the $8 million we recognized in the third quarter of 2020. We could see the same outcome in Q4 of this year compared to the $11 million received in Q4 2020. As we have stated in the past, we continue to actively appeal and pursue previously denied claims, but the cadence and size of these Medicare payments are impossible to predict. Third quarter gross profit was $103 million, which equates to a gross margin of 77% for the quarter. The moderately lower gross margin in the third quarter was driven by an increase in Zai Lab purchases in the quarter. SG&A expenses for the third quarter were $64 million, an increase of 13% from the third quarter of 2020. As we approach multiple late-stage data readouts, we remain committed to strategically investing in operational readiness measures designed to ensure efficiency at launch and potential new indications. We invested $48 million in research and development activities in the quarter, an increase of 47% versus the same period in 2020. This marks our fourth consecutive quarter of investing more than $40 million in R&D. While we have already reviewed our growing clinical trial pipeline, we are equally excited about the product development opportunities before us. We believe we have substantial organic opportunities to enhance all components of our delivery system. Our development teams are experimenting with a variety of new materials, designs, and processes. We believe there is long-term potential in continued product development, and we’ll continue to invest aggressively in this space. Our net loss for the third quarter was $0.13 per share or $13 million. We are focused on leveraging our cash-generative GBM business to aggressively invest in future growth opportunities before focusing on short-term profitability. This includes both research and development initiatives and continued organizational readiness build-out ahead of potential future launches. In addition to earnings per share, we evaluate performance based on adjusted EBITDA, a non-GAAP measure of earnings before interest, taxes, depreciation, amortization, and shared-based compensation. We believe this is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material noncash items, and best reflects the financial value generated by our business. In the third quarter of 2021, we generated adjusted EBITDA of $20 million. To put this into greater context, our adjusted EBITDA margin this quarter was 15%, due to our research and development investment reaching 36% of our net revenue. We ended the third quarter with $934 million in cash on hand. Our cash position gives us the flexibility to pursue multiple avenues for growth without finance-constrained trade-offs. This is especially important given our extraordinary amount of organic growth opportunities. If you take anything away from the quarter, it should be that the fundamentals of the Novocure business are strong and stable, and we are approaching a key inflection point. We have built a sustainable business in GBM. Several of our late-stage trials are approaching full enrollment with final data expected in the next 24 months. Tumor Treating Fields as a platform therapy is, we believe, only just scratching the surface of its full potential. Our clinical, commercial, and operational expertise, combined with our financial strength, allow us to pursue a multitude of organic growth opportunities. We believe these core strengths will enable us to continue our mission as we strive to extend survival in some of the most aggressive forms of cancer. With that, I will turn it back to the operator for Q&A. Thank you all for your time this morning.

Operator, Operator

Our first question comes from Cory Kasimov with JP Morgan.

Cory Kasimov, Analyst

I’m just curious if you have any incremental color on ovarian and how long it might take the DMC to complete the analysis? And will there be a press release or disclosure upon this analysis if it's just to go to the end? And then, the second question I have for you is regarding your gastric trial and what you’re looking for in that Phase 2 study to give you confidence to advance that indication into a pivotal trial, knowing it’s primarily an Asian market that you’re looking into? Thank you.

Bill Doyle, Executive Chairman

Hi. Good morning, Cory. This is Bill. And as we’ve done in the Q&A sessions during the pandemic, I’m joined by my senior team from various locations around the world. So, I’ll be directing the questions. But, I’ll take your first two. With respect to INNOVATE, we are extremely proud and pleased of the fact that we have completed the enrollment of this trial. Anyone on the call who knows what a huge effort it is to conduct a major international randomized clinical trial in cancer will understand the effort that this has required. And we’re particularly thankful for our partners ENGOT and GOG. With respect to the interim, all of our trials are designed to go to full enrollment and then to complete the full follow-up. The DMC is an independent body. And as an independent body, they determine their timing. We will press release the results of the interim. But again, I want to underline that our expectation is that the trial will proceed to conclusion. With respect to the gastric Phase 2 trial that we’ve conducted with our partner, Zai Lab in China, that is another achievement. Again, the Phase 2 trials are smaller, but this is the first trial that we have undertaken in the very large China market. We mentioned that gastric cancer is highly prevalent in China and throughout Asia. So, it’s not just China, Korea, Japan also have high prevalence of gastric cancer. And it is a cancer that’s also prevalent in the U.S., although to a lesser extent. With these Phase 2 trials, we look at a lot of different things. First and foremost, safety, of course; and then, we look at what we often call hints of efficacy or the efficacy signals. And from there, determine not only if we’ll go forward with a Phase 3 but the exact design of the Phase 3. The other thing, of course, that we take into account is the standard-of-care. In some cases, as has been the case in our liver cancer indication, the standard-of-care may have evolved. And so, the Phase 3 trial will incorporate the current standard-of-care. So, I hope that gives you some clarity.

Operator, Operator

Our next question comes from the line of Jason Bednar with Piper Sandler.

Jason Bednar, Analyst

Hey. Thanks for taking our questions. Two from us today, one on the commercial side, one on the pipeline side. Maybe starting first with the commercial, and I’m sorry, it’s a bit of a two-parter here. This is the third quarter in a row where revenues and the Street expectations, and that gap versus the Street does seem to be widening. I get the message on the business maturing, I think it’s been pretty clear. But I guess, do you think you need to take the next step and provide more formal revenue guidance in order to have expectations be more consistent with what you think is appropriate for the prescription activity in active patients that you’re actively seeing? And then, I guess related to that, if the GBM business is maturing, I mean, what do you see as the right growth rate for this business once we get past challenges that COVID is creating for you guys?

Bill Doyle, Executive Chairman

So, good morning, Jason. Thanks very much for the question. I guess, I’ll start the answer, and then I’ll pass it to my colleagues to be more specific. But, first and foremost, of course, our GBM business is extremely strong and sustainable, and the cash from that GBM business, as we’ve described, is fueling the aggressive investments that we’re making for future growth. With that said, and no one at Novocure is content with the 30% to 40% penetration in our key markets, simply from the human side. We know that the patients that we are not reaching can benefit from our therapy. And notwithstanding the last two quarters of flattish performance, we are determined to get to those patients. Maybe specifically with respect to the delta between performance and Street expectations, Ashley, maybe you would like to give some color on that topic.

Ashley Cordova, CFO

Sure, I’m happy to. And Jason, thank you for the question. This is obviously something we focus a lot on internally as well. And I do want to highlight that we do provide substantial qualitative guidance on multiple facets of the business. And I think you can expect us to continue to do that over time. Specifically with regards to this quarter, you’ve heard us message consistency and stability within our GBM business. We clearly see multiple levers for future growth, but these elements of growth will take some time. Additionally and importantly, we’ve stated that the favorable difference in growth rate between our operating statistics and net revenues would compress as our commercial organization matures. And that delta, Jason, is now closing with the completion of our Medicare ramp. This means that you can look to active patient trends as an indicative indicator, per se, of future revenue trends. And I think in the near term, that’s what we would ask you guys to look at those active patient trends.

Jason Bednar, Analyst

Okay. All right, very helpful. And then, on the pipeline, I guess, wondering if you can speak to just the level of confidence in your updates today, I guess, in the context of what’s still a fluid environment with COVID, and now some supply constraints that seem to be impacting the PANOVA trial. Totally appreciate there’s only so much that’s in your control, but you have been moving more aggressively to bring on new sites for METIS and LUNAR in the last few months to get those over the finish line. So I guess, just, again, sitting here today, just your level of confidence on some of the upcoming items getting those last patients in on LUNAR and METIS, and gain some of the other clinical trials kicked off that you’ve announced here.

Bill Doyle, Executive Chairman

Yes, sure. So, when we start a clinical trial, we make an estimate about the pace of enrollment and the number of centers that we will open and the timing for the opening of those centers and we project a last patient in. Those are obviously affected by lots of different variables as we proceed. Some of them are unexpected, right? COVID, completely unexpected, the duration of COVID unexpected. Others can be the amount of competition in a particular indication, etc. As the trial proceeds, our confidence in those forecasts goes up, meaning that we see the pace, we see the performance of the centers, we know what the footprint looks like. So obviously, INNOVATE, our confidence is 100%. We’re done. We’re getting close to LUNAR, our confidence is high. METIS is next. I’d say our confidence is high. And then, sometimes we’re just affected by things that are very unexpected. We would never have projected a global shortage of ABRAXANE, for instance. That is very specific to PANOVA. And we’re also dealing, as Asaf mentioned, with issues with the Chinese regulators to get ABRAXANE into the centers in China. So those are clearly beyond our control, but we’re working very hard to accommodate our centers for those issues. And we updated the timing of that particular trial as soon as it became clear that it was going to affect the timing of the last patient. And so, I would say, generally, our confidence today is higher than it’s been ever, in large measure because of the passage of time for these trials.

Jason Bednar, Analyst

Could you let us know when the last patient was enrolled in INNOVATE? Was it recently, perhaps in the last week or two? I’m trying to gauge when we might expect the DMC update. Thank you.

Bill Doyle, Executive Chairman

So, again, I think we don’t spend much time between the last patient enrolling and when we announce. It was recently that we reached that milestone. However, I want to emphasize that we do not control the timing regarding the Data Monitoring Committee. They will certainly carry out their work, but it’s difficult to pinpoint the exact timeline from the last patient being enrolled. I just wanted to clarify that.

Operator, Operator

Our next question comes from the line of Vijay Kumar with Evercore ISI.

Vijay Kumar, Analyst

Bill, could you provide a broader perspective? It seems the pandemic has impacted the entire sector. Can you quantify how it has affected patient access? Is the situation improving? Should we be cautious for Q4 as well?

Bill Doyle, Executive Chairman

Yes. Good morning, Vijay. Thank you for the question. I’m going to pass this over to Pritesh Shah, our Chief Commercial Officer, who is here with us this morning. Pritesh, perhaps you can share some insights regarding the impact of COVID on the core business.

Pritesh Shah, Chief Commercial Officer

Yes. Vijay, thank you for the question. And, of course, COVID certainly is a factor and has a backdrop of everything that we’re doing today. One of the key things that we’re seeing in terms of patient flow is that the clinic traffic and just how patients are diagnosed, how the treatment plan is put into effect, all those things are changing. They’re dynamic, and depending on the region, they’re changing and shifting compared to how the COVID cases go up and down in different regions. Something that we can share specifically related to brain surgery, which is a key aspect of how Optune is then incorporated into the treatment plan. We’ve seen that brain surgery is down approximately 20% in the U.S. And another element compared to that that we’re also facing is face-to-face time with physicians. So, the clinics are turning into telehealth, sometimes physicians are in, sometimes they’re not. We’re seeing restrictions in our team’s ability to get to the centers. So, the general interaction that we would have is shifting, and we’re having to find new ways to engage both the physician and also the patient when we’re able to engage the patient. And I would say what drives us on this front is to make sure, Bill mentioned, we’re certainly not happy with the number of patients that have been treated to date because we believe the strength of our product, the clinical profile, as well as the positioning in the guidelines allows all eligible patients to have a discussion around Optune. So, engagement and education really becomes an important aspect. And what drives us now are medical meetings are opening up. We were just at ASTRO where it was a hybrid meeting, but we were able to see and interact with the physician base. Society of Neuro-Oncology is coming up. Again, we’ll have another opportunity there to engage with their core stakeholders. And these things give us further energy and drive to say, hey, we want to make sure that no patient is left behind who is eligible for our treatment.

Vijay Kumar, Analyst

Understood. I have a follow-up question on the clinical side, which is actually two parts. First, can you clarify regarding the ovarian trial? When you mentioned that Novocure will release the results, will you have access to the complete analysis, or will it just be a brief statement indicating whether the trial has met its goals or is expected to be completed? Secondly, regarding EF-31, do we have any details about the trial design? What level of treatment efficacy do we need to achieve to ensure statistically significant results?

Bill Doyle, Executive Chairman

Sure. In response to the first question, we do not receive any data from the interim analysis, so we have no updates to share. We get feedback from the Data Safety Monitoring Board regarding whether the trial should continue, be halted for success, or stopped for failure due to safety or futility. We anticipate the trial proceeding to conclusion, which is our plan. When we do receive that feedback, we will issue a press release as we have done before. Regarding EF-31, we evaluate all available information from these open-label trials. We recently conducted a similar review with HEPANOVA, taking into account patient characteristics, safety profiles, and standard efficacy measures to decide if investing in a Phase 3 trial is warranted. Historically at Novocure, every Phase 2 trial we've conducted has shown enough safety, tolerability, and efficacy signals to justify moving to Phase 3. We will apply the same analysis for EF-31 once we have full access to the data on gastric.

Operator, Operator

Our last question comes from the line of Greg Fraser with Truist Securities.

Greg Fraser, Analyst

I was wondering if you could comment at least high level on the pipeline of potential partnerships with other oncology companies that would study Optune in combination with other oncology agents. And then, I just had a quick follow-up on GBM. I was wondering if you could comment maybe qualitatively on how prescription volumes have looked so far in Q4, and whether you’ve seen some improvement in the pandemic-related headwinds.

Bill Doyle, Executive Chairman

Good morning, Greg. I’ll address the first question regarding partnerships. We are very excited about our collaborations with leaders in oncology who are advancing complementary or synergistic treatment approaches. The first partnership we announced was with Merck, focusing on first-line non-small cell lung cancer. The trial we are conducting with Merck in this area is highly complementary to our LUNAR trial in second-line non-small cell lung cancer and our METIS trial in brain metastases resulting from non-small cell lung cancer. This trial is grounded in preclinical data we've gathered on combining Tumor Treating Fields with immunotherapies, revealing significant potential for these modalities to work together more effectively than either could on its own. The second program we announced this quarter is similarly focused on pancreatic cancer, collaborating with Roche. Here, we are pairing an anti-PD-L1 immunotherapy in a context where such therapies have not had a substantial impact alone, but our preclinical data indicates that the combination could be greatly beneficial for patients. This program is complementary to PANOVA-3, which is enrolling patients with locally advanced pancreatic cancer, while our collaboration with Roche targets those with metastatic disease. We envision Tumor Treating Fields contributing to immunogenic cell death and possibly enhancing the effect on the primary tumor, while the energized immunotherapy can address the metastatic spread. Partnerships like these are very appealing to us. Although we do not discuss trials or projects that are not officially announced or finalized, we are certainly keen on exploring additional programs of this nature. I’ll also mention another program we have, and we’ve announced a program with a small company that has a unique brachytherapy. So brachytherapies are radiation sources that are implanted at the time of surgery to treat a cancer, or they’re introduced and then removed via specialized equipment, again during a surgical procedure. In this case, we’re able to combine Tumor Treating Fields with a brachytherapy source that is implanted at the time of surgery by a neurosurgeon for recurrent GBM. This is a case where the company is small, but where the therapy is extremely promising, and the combination of our therapy and the brachytherapy offers the possibility of tremendous benefit to patients. So, we’re interested in both kinds of partnerships. Clearly, the partnerships with the therapeutic leaders, like Roche and Merck, present great opportunities for patients and great opportunities for expanding our programs. But the programs with the little companies, the small guys that have unique therapies are also important for us and important for patients. So, we’re working on both types of partnerships in the future. And then, with respect to your second question on prescription trends, of course, we don’t guide. We don’t talk about the future. But, Pritesh, maybe back to you for a little more color on what you’re seeing in the marketplace.

Pritesh Shah, Chief Commercial Officer

Thank you, Bill, and I appreciate the questions. I want to emphasize the ongoing significant unmet clinical need for GBM patients. Our mission and passion remain focused on ensuring these patients at least discuss Optune, and we provide the necessary support to help them make informed decisions. I'll highlight a couple of programs designed to assist in this area, allowing us to connect with patients who present in the clinic. One program in the U.S. is called Considering Optune, which lets our teams discuss the technical aspects of our therapy with patients. This ensures that those who arrive for discussions about Optune are better prepared to consider and utilize the therapy. Additionally, I mentioned two key congresses on the horizon; one has already concluded where we presented 15 abstracts featuring clinical data, giving our teams a chance to engage with attending physicians. The upcoming event is the Society of Neuro-Oncology. These opportunities are essential for us to continue educating and raising awareness about Optune and the significant unmet need in GBM, which will drive our business this quarter.

Bill Doyle, Executive Chairman

And maybe, Greg, what I’ll add to that is that throughout our organization, as we’ve mentioned a number of times, we want to reach all these patients. We know that we are underpenetrated in academic centers. These centers focus primarily on research and drug development. Neuro-oncology has been an area where neuro-oncologists are experimenting with new drugs and combinations. Our teams are very focused on engaging these research sites on their own terms, and this engagement occurs in various ways. We have a well-developed program in investigator-sponsored trials, where the investigator presents the concept. This program is not limited to the U.S.; it is international. We mentioned in the prepared remarks an investigator-sponsored trial that recently opened at Stanford, for instance. We are also now opening centers for our TRIDENT trial, which is a large randomized study testing the use of Optune with radiation therapy in first-line GBM, rather than waiting until after radiation. These investigator-sponsored trials and studies like TRIDENT allow academic researchers to engage in research that interests them while providing hands-on experience with the therapy that we believe will influence their non-research or nonclinical trial practice. We have many efforts underway, both standard commercial initiatives and these research efforts, to reach the patients who we know can benefit from the therapy.

Operator, Operator

There are no further questions. I will now turn the call back to Executive Chairman, Bill Doyle, for closing remarks.

Bill Doyle, Executive Chairman

So, first, I’d like to thank everyone for your time this morning. We appreciate your interest in Novocure. I also need to thank all the Novocure team members on the call and who are listening today. We know that working in this extended pandemic environment is extremely difficult, and I want to thank you for your continued focus and dedication to our mission. I’ll end where I began. The fundamentals of our business at Novocure are strong. In fact, they’re stronger than they’ve ever been. Our sustainable business in GBM is generating financial strength that has actually underlined, allowing us to invest in organic growth opportunities without regard to financial constraints or trade-offs. We made great progress in the quarter, notwithstanding the external environment. We couldn’t be happier with the progression of INNOVATE-3, and we look forward to sharing that data in the coming years. And as we discussed, we’re also very pleased with the progress on the other trials, notwithstanding the ABRAXANE issues that we’re working to solve in PANOVA. We believe we’re approaching a major inflection point for our Company as we progress to the conclusion of these trials, and we’re investing to prepare to be a substantially different company in the not-too-distant future. And by substantially different, substantially larger, treating substantially more patients with the progress that we hope to undertake. So, thanks again, and we’ll see you next quarter.

Operator, Operator

Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.