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NovoCure (NASDAQ:NVCR)
Q3 2021 Earnings Call
Oct 28, 2021, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Good day, ladies and gentlemen, and welcome to NovoCure's third-quarter 2021 earnings conference call. At this time, all participant lines are on a listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will be given at that time. [Operator instructions] As a reminder, this call is being recorded.

[Operator instructions] I would now like to turn the call over to your host today, Ingrid Goldberg, vice president of finance and investor relations. Please go ahead.

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 view on our website, www.novocure.com, by clicking on the link for the third-quarter 2021 financial results located in the Event section of our Investor Relations page.

Before I 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 three and nine 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 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, which see a sizable portion of the GBM population where we are underpenetrated.

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 initiation 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 reduced cancer patient engagement with physicians, delayed surgeries, and stressed 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 till 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 median overall survival rates 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?

Asaf Danziger -- Chief Executive Officer

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 partners, ENGOT and the GOG Foundation, INNOVATE 3 is the largest abdominal trial to complete enrollment in the history of NovoCure and 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 to-the-top investigator-sponsored trial. To-the-top is a single-arm trial studying the impact of TTFields together with immunotherapy for the treatment of newly diagnosed GBM. In to 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. With that, I will pass the call over to Ashley to discuss our financial results.

Ashley Cordova -- Chief Financial Officer

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 share-based compensation. We believe this is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material 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 revenues. 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, which we believe is 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.

Questions & Answers:


Operator

Thank you. [Operator instructions] Our first question comes from the line of Cory Kasimov with J.P. Morgan. Your line is open.

Cory Kasimov -- J.P. Morgan -- Analyst

Good morning, guys. Thanks for taking the questions. 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 like a press release or disclosure of [Inaudible] 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 3 trials are smaller, but this is the first trial that we have undertaken in the very large China market. We mentioned the 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.

Cory Kasimov -- J.P. Morgan -- Analyst

Yes. Thank you. Appreciate it.

Operator

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

Jason Bednar -- Piper Sandler -- Analyst

Hey, thanks for taking the questions. Two from us today. One on the commercial side and 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 in The Street expectations. And that gap versus The Street does seem to be widening. I get the best 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 is the right growth rate for this business once we get past challenges that COVID is creating for you guys?

Bill Doyle -- Executive Chairman

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, we 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 were not reaching can benefit from our therapy. And notwithstanding the last two quarters of flattish performance were 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 -- Chief Financial Officer

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 meeting 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, are those active patient trends.

Jason Bednar -- Piper Sandler -- Analyst

OK. Very helpful. And then on the pipeline, I guess wondering if you can speak to just 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 so much that's in your control, but you have been moving more aggressively to bring on new sites for medicine LUNAR 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 then getting 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 forecast 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 -- Piper Sandler -- Analyst

All right. If I could just squeeze in one more. Maybe could you just help us with exactly when that last patient was enrolled on INNOVATE? I mean, was it -- I'm sorry if I missed this, but was it like within the last week, last couple of weeks? I'm just trying to get a sense of maybe what we can expect that DMC update. Thank you.

Bill Doyle -- Executive Chairman

So, again, I think the last -- we don't, first of all, spend a lot of time in between last patient in and when we announced. So, it was recently that we were able to mark that milestone. But I do want to say with respect to the DMC, I want to underline again, we don't control that timing. So, no doubt they will do their work.

But it's hard to triangulate perfectly from the time of the last patient in. I just want to state that. 

Jason Bednar -- Piper Sandler -- Analyst

Understood. Thank you.

Operator

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

Vijay Kumar -- Evercore ISI -- Analyst

Hey, guys, thanks for taking my question. One, Bill, maybe a big picture. Clearly, the pandemic seems to have had an effect across the space. But can you guys quantify what the pandemic impact was in terms of patient access? Is that improving? Or should we be conservative for Q4 as well?

Bill Doyle -- Executive Chairman

Yeah. So, good morning, Vijay. Thanks for the question. I'm going to turn this one over to Pritesh Shah, our chief commercial officer, who's with us this morning.

Pritesh, maybe you can provide a little bit of color on the ground with respect to COVID in the core business.

Pritesh Shah -- Chief Commercial Officer

Yes, Vijay, thank you for the question. And, of course, COVID certainly is a factor in the 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, just 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, as 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-based 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 -- Evercore ISI -- Analyst

Understood. And my follow-up, one on the clinical side. Actually, a two-parter, if you will. Just a clarification on the ovarian, Bill.

When you said no if you will press release the results, will you have access to the complete analysis? Or is this just a one-line statement saying the trial hit fruition or is expected to enroll to completion? And then on EF-31, do we have some details on the trial design? What kind of treatment efficacy are we expected to see to hit stat significance?

Bill Doyle -- Executive Chairman

Sure. So, with respect to the first question, the answer is straightforward and is consistent with all of our trials. So, we do not receive any data the interim analysis. So, we have nothing to pass on.

We receive the feedback from the Data Safety Monitoring Board with respect to should the trial proceed, should the trial be stopped for success, or should this trial be stopped for failure, either for safety or for futility? And we fully expect the middle case herewith, as I said before, which is to proceed to conclusion, and that's what we're planning. And we'll, as I answered previously, when we receive that feedback, we will, of course, press release it as we have in the past. With respect to EF-31, we look at the totality of the information available from these trials. These are open-label trials.

And we just went through this exercise recall with HEPANOVA with everyone where we look at the patient characteristics that are enrolled. We look at, of course, the safety profile. And then we look at all the standard efficacy measures to determine whether we believe an investment in a phase 3, which, again, I underline is a very large undertaking is worth it. Now, I will say, to date at NovoCure, we've found in every phase 2 that we've performed that the combination of safety, tolerability, and the efficacy signals that we've seen have justified moving forward to a phase 3.

So that's our track record to date. But we'll do the same sort of analysis when we have full access to the EF-31 data in gastric.

Vijay Kumar -- Evercore ISI -- Analyst

Understood. Thanks, guys.

Operator

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

Greg Fraser -- Truist Securities -- Analyst

Good morning, folks, and thanks for taking the questions. 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

Sure. So, good morning, Greg. I'll take the first question with respect to partnerships. So, we are extremely enthusiastic about our partnerships with oncology leaders, who are commercializing complementary or synergistic therapeutic modalities.

The first partnership, of course, we announced was with Merck in non-small cell lung cancer -- first-line non-small cell lung cancer. The trial that we are undertaking with Merck in first-line non-small cell lung cancer is highly complementary to our LUNAR trial in second-line non-small cell lung cancer and our METIS trial in brain mets from non-small cell lung cancer. And of course, it is a trial that is based on the preclinical data that we've seen in combining Tumor Treating Fields with immunotherapies and the real opportunities for those two modalities to work together and to do a better job than either modality alone. The second program that we announced this quarter is quite similar, actually, focused in pancreatic cancer with Roche.

Again, we're combining with an anti-PD-L1 immunotherapy in an area where anti-PD-L1 therapies have not made a significant impact alone, but where all of our preclinical data suggests that the two therapies together could have a great benefit for patients. And again, it's highly complementary to PANOVA 3. PANOVA 3 is recruiting patients with locally advanced pancreatic cancer. So pancreatic cancer that has not spread beyond the peritoneal region.

Our program with Roche is focused on metastatic patients. So, think of Tumor Treating Fields providing the immunogenic cell death and kick-start plus it's antimitotic effect to the pancreas of the primary tumor, but then the immunotherapy that's been energized or kick-started by Tumor Treating Fields doing its job on the metastatic spread. Trials like this or partnerships like this are very interesting to us. And while we don't talk about trials that or work that hasn't been announced or hasn't been finalized, we are certainly interested in pursuing additional programs like this.

I'll also mention another program we have, and we've announced a program with a small company that has a unique brachytherapy. So brachy therapies 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. And 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 offer 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

Yes. Thank you, Bill, and thank you again for the question. So, I'll highlight here the significant unmet clinical need that remains for GBM patients. So not only our mission, but our passion remains to make sure that all of these patients have at least a conversation about Optune and then we provide the support necessary to help the patients make decisions.

So, some of the things highlight a couple of programs that help on this front that allow us to continue taking advantage of those patients that are presenting in the clinic and those patients that we continue to have access to. And one such program in the U.S., we have a program called Considering Optune, which allows our teams to talk about the technical aspects of our therapy with patients. And this, again, helps ensure that those patients that are coming in, having a discussion around Optune are more prepared to consider the therapy and to take advantage of the therapy. In addition to that, what I mentioned are two key congresses that take place in this horizon, one already took.

We had 15 abstracts there. So, it was clinical data that was presented. Our teams had opportunities to engage with physicians that were at that congress. Another one coming up is Society of Neuro-Oncology, as I mentioned.

So, these opportunities, again, help us continue to educate, raise awareness around Optune and the high unmet need that remains in GBM, and this is -- will be one of the drivers for our business in 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 academic centers are focused on research and specifically focused on drug research. Neuro-oncology has been an area where the work that is done is primarily on -- by neuro-oncologists is experimenting with new drugs and new combinations.

Our teams are very focused on engaging these research sites on their own terms. And this engagement comes in a number of ways. We have a very developed program in investigator-sponsored trials. These are trials where the investigator comes with the concept.

And I will say this is not just in the U.S., this is an international program. We mentioned in the prepared remarks an IST that has been opened recently at Stanford, for instance. And we're also opening now the centers for our TRIDENT large, randomized trial, where we are testing the use of Optune with radiation therapy in first-line GBM rather than waiting until after radiation. These ISTs and trials like TRIDENT allow the academic researchers to engage in the research that is of interest to them, but it also gives them that hands-on experience with the therapy that we believe will then bleed into or begin to be used in their non-research or nonclinical trial progress.

So, a lot of efforts going on standard commercial efforts, as well as these research efforts to get to these patients that we know can benefit from the therapy.

Greg Fraser -- Truist Securities -- Analyst

Thank you. That was very helpful.

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, allows 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 signoff]

Duration: 54 minutes

Call participants:

Ingrid Goldberg -- Vice President of Finance and Investor Relations

Bill Doyle -- Executive Chairman

Asaf Danziger -- Chief Executive Officer

Ashley Cordova -- Chief Financial Officer

Cory Kasimov -- J.P. Morgan -- Analyst

Jason Bednar -- Piper Sandler -- Analyst

Vijay Kumar -- Evercore ISI -- Analyst

Pritesh Shah -- Chief Commercial Officer

Greg Fraser -- Truist Securities -- Analyst

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