Good afternoon, everyone. Thanks for joining us at the HC Wainwright 27th Annual Global Investment Conference. My name is Emily Bodner, and I'm an Equity Research Analyst at HC Wainwright. Please introduce our next fireside chat with Novocure. I'm here with Ashley Cordova, Chief Executive Officer of the company. Maybe to start, for those who are newer to Novocure, maybe just talk a bit about Tumor Treating Fields technology, how it works, and also your kind of initial commercial success in glioblastoma.
All right. Thank you, Emily. Glad to be here today and nice to see everybody in the room. Novocure has one clear mission. We are striving to extend survival for patients with some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields. Tumor Treating Fields are electric fields that we apply to the region of solid tumors to disrupt cancer cell death. If I can take everyone back to their high school physics class, they understand that electric fields can exert forces at a distance on charged molecules, just like a magnetic field or a gravitational field can on masses. The core insight that led to the founding of Novocure was that many of the proteins, which are critical to cancer cell division, are highly polar.
If we can get an electric field inside that cancer cell, which we're able to do by frequency tuning the field that we deliver, we are able to disrupt the mitotic process. Increasingly, we're learning in ongoing research that, beyond the initial anti-mitotic effect, for cells that do divide, there are many downstream irregularities that trigger immune stimulation. We do know that we have a downstream effect of immunogenic cell death. We see all the classical signs of stress and immune stimulation. I think as we look ahead to the applications, we're interested in how can we combine Tumor Treating Fields with whatever the best standard is, particularly with immune activating agents as we look ahead. That's the therapy. We are at the cusp of a multi-indication platform.
We have a commercial business today in GBM, but we have clinically de-risked three additional indications that are either launching or pending to be launched by the end of next year. This is all supported by the strength of our commercial business in GBM. To directly answer that question, we are 10 years into that launch. We have a business that generates $600 million in net revenues annually. If it were a standalone business, it would generate a significant amount of free cash flow. Since we hit that first phase of profitability in 2020 with GBM, we have begun investing in R&D. You see us now standing in hand, as I said, with three additional indications, either launching or pending launch over the next year.
Yeah. Obviously, you mentioned you've been commercial almost 10 years in GBM. Are you kind of at the point where you've hit peak penetration, or is there more room to grow in the U.S. particularly? Maybe talk about some of the other trials, like the Trident trial, which you're reading out next year, and how that could potentially contribute to additional growth.
Yeah. GBM is really our solid foundation upon which we have the financial strength to grow ahead. It is a growth engine in and of itself. It is a mid-single-digit growth engine, is what I would classify, but it's consistent and durable. As we look back at active patient growth for the last, I believe, nine quarters, we've seen between 6% and 12% active patient growth. That's how I would frame GBM. We're always looking to grow, but it is a mid-single-digit growth. That growth comes both from increased penetration in our active markets and from geographic expansion. It does provide a foundation upon which we're able to invest. As we look ahead to accelerating top-line growth, it's going to come from the addition of lung cancer, pancreatic cancer, and brain metastases onto that platform. One important point about the platform is that we know how to deliver this therapy.
We have the go-to-market model. We have the device support specialists that are able to bring this therapy to patients. We know how to manage the reimbursement processes and get paid. Importantly, from a sales and marketing leverage, we have the field teams we need in place to launch all of our indications as we look ahead, which provides a clear path to profitability.
Maybe shifting to non-small cell lung cancer, which is your most recent launch, and you're a few quarters into that. Maybe just generally, how has the launch been relative to your expectations? What's been like the initial experience for patients with therapy?
Yeah. Setting the context, we're transitioning now from a GBM business with $600 million mid-single-digit growth to a multi-indication portfolio with diversified growth opportunities as we look at exiting next year. Of our three launch indications, we always knew lung would be the hardest. It is, in fact, the hardest, is how I would describe it as we look to the initial launch. It is a highly competitive space, and it is rapidly evolving. It is also the first time we are introducing a device to the general medical oncology community, which is very much a drug-based world. I can compare and contrast that to mets and pancreatic, where pancreatic is far less competitive. We have the first extension in overall survival that this space has seen in a very long time. The brain metastases indication, which is a customer segment, the radiation oncologist that knows us well.
Those are the challenges. Transparently, we must acknowledge the facts on the ground that the launch is behind expectations. The duration of therapy is such that we need to refill that pipe every quarter to drive meaningful incremental growth. That said, we are making the adjustments we need given the realities of the marketplace. As I look ahead to where the portfolio will sit exiting next year, we are as confident as we've ever been in the opportunity to accelerate top-line growth. The investments we're making today to educate the medical oncology community will bear fruits both for the lung cancer indication, but specifically for the pancreatic cancer indication as well. Acknowledging the fact that we have a lot of work ahead of us to launch, again, a device in a drug-based world. Looking ahead to the portfolio of opportunities we have as we exit next year.
Maybe you can talk a bit about the breakdown between prescription use that you've seen, including combinations with either checkpoint inhibitors or docetaxel based on the LUNAR trial. If you're noticing that the drug is being used kind of as indicated by the label.
Our label for Optune Lua is in metastatic non-small cell lung cancer post-platinum, and that's where we see the primary usage. The question I think of the market was, would the physicians be comfortable using this in an ICI retreatment setting? We are seeing the answer to that is yes. We see more than 90% of our patients have ICI first line in combination with the platinum, and then they're progressing on the platinum and switching out for Optune Lua. That's where we're seeing our prescriptions come from, and that is as expected. That's where the market is.
How are you, I guess, prioritizing growth strategies currently? Obviously, devices tend to be a bit slower to launch in general. How should we be thinking about maybe the next year or so? Do you think by then potentially things might accelerate from where you are now?
Definitely. I mean, we're looking ahead to accelerating top-line growth with a clear path to profitability. If there are two messages I could have everybody take away from that Novocure story, those are the two messages. Part of this is just the benefit of having the commercial go-to-market model that we can pull through all of these additional indications on. It is the same field team that's out doing the medical education to the medical oncologist today for Optune Lua that will be launching our pancreatic indication. It is the same field team today detailing Optune Lua to the radiation oncologist that will be detailing our metastatic indication.
As we look at the ability, not just on the sales and marketing side, but also in the G&A side and reimbursement and patient support, we have a significant amount of leverage in the P&L, and we're committed to pulling that leverage through. The message is, again, as I look ahead, four to six quarters are accelerating top-line growth and in a clear path to profitability.
Maybe you could touch a bit on where you currently are with launching outside the US and lung, and how you kind of expect these different markets to compare to your experience in the US.
Yeah. It's a great question. We've launched in the U.S. and Germany with Optune Lua, and we're looking ahead to Japan. That is the approval that we would expect before the end of the year. We have approval in Europe, but the rest of the markets will be gated on reimbursement. As we look ahead for the near-term opportunity, it's in the U.S., Germany, and Japan. I do want to spend one minute on Japan because I think it will be a material market for Novocure. It is today in GBM, but relative to the opportunity in GBM, we have a significantly greater opportunity in future indications. GBM under-indexes in East Asian populations, so the incidence is lower in Japan than it is in our Western European populations for GBM. It over-indexes on pancreatic cancer and non-small cell lung cancer. It is a single-payer market.
Once you get approved, you can expect about two quarters later that you will get reimbursed. It literally is a switch that turns on. As you drive demand, you're able to pull that top-line growth through. We have a very well-operating team in market. We have a very strong leader in Japan. As I look ahead, I think it will be a story that we're talking more and more about over the next two to three quarters in the near term.
Maybe shifting to pancreatic cancer, which we touched on briefly. You just submitted the PMA for that indication. Maybe walk us through a bit with the PINOVA-4 data that you presented and what some of the KOL physician feedback has been on the trial.
Yeah, it's great. We often say, you know, if of our three children, you know, lung is our problem child, but pancreatic is the child that just consistently is delivering, right? I would say this is an indication that is offering the first extension in overall survival that this specific setting of care has ever seen. It is unusual to have a large randomized phase 3 trial in pancreatic cancer read out with a positive benefit. The overall survival benefit is clinically meaningful. Importantly, beyond the extension in OS, which we saw a two-month extension in OS, we see a significant six-month extension in pain-free survival. Physicians now have the opportunity not only to help their patients live longer, but live better. I will tell you, the community is engaged. We're doing the standard rounds of, you know, ad boards and engagement that we would do.
We were at ESMO GI with the pain-free data in July, and it was just a lot of fun to talk to the community. They had seen the data that we presented at ASCO a month prior, where we were front page of the ASCO Daily News. Physicians are coming to us asking for the education opportunity versus, you know, us having to generate the mind space with them. There's a lot of interest and engagement from this community. There's a lot of partnership as we look at future areas of research. There's a lot of excitement as to how Tumor Treating Fields will change the way that we treat pancreatic cancer moving ahead.
Maybe discuss a bit about what the market opportunity could look like in pancreatic cancer. I guess, what % of pancreatic cancer patients are locally advanced versus metastatic?
Yeah. Again, at a macro level, there's no reason why long-term we should not be able to demonstrate a benefit to Tumor Treating Fields across all settings of care in pancreatic cancer. There's metastatic to locally advanced, and in combination with both the standards today and future innovations, we're looking at all of that. Our indication at launch will be in locally advanced pancreatic cancer in combination with gemabraxi, which is one of the two standards of care in locally advanced. From a market sizing, we estimate that to be about 16,000 patients in the U.S., which for context is double the size of our GBM incidence, and duration of therapy is the same. It's a multiple of the GBM incidence with the indication we have today. That's about a third of the non-surgical candidates, and the other two-thirds are in metastatic.
We do have a phase two trial reading out of metastatic cancer early next year. This is, as I said, an area of ongoing research and an area we will certainly look to extend into. Our launch today will be in locally advanced.
Yeah. As you mentioned, you looked at the combo with gemabraxine. Obviously, the other regimen is Folfirinox. The question often comes up of how often are either of these used, and does it make a difference which one you're combining with?
Yeah. Again, broad strokes, we would look to be combining with both as we generate the data. The data that we have today is in combination with gemabraxine. It's about 50-50. Now, the Folfirinox combination, which is the other standard, is highly toxic. It is typically reserved for your healthier, high-KPS patients, and it also is something that you need to modify the dose down. Patients go in, it is a set of five infusions, and it's actually quite a burdensome kind of treatment, and then it modifies down. From a clinical trial setting, we're exactly where we want to be from a gemabraxine combination. We are hopeful that we'll be able to displace some of the Folfirinox use because transparently, we have a significant extension in overall survival that Folfirinox has not shown in this setting.
We are also going to be looking at the best way to generate ongoing evidence in combination because we do not think there is a scientific rationale for why we shouldn't be exploring the combination with all of the above.
Maybe discuss a bit about timing toward when you would expect FDA approval now that you've got the submission in and also how you're preparing for launch. Obviously, you already have a sales force kind of in place, but any other things you're doing in advance of approval?
Yeah. We are getting ready. The package is in at the FDA. It was submitted on August 15. There is a 180-day clock, but that clock does stop with questions back and forth. There will always be some questions. We guide nine to 12 months post-submission as our best estimate of launch timing, which would put launch in summer of next year. We're preparing, right? We're doing the work to get the marketing campaign up and running. As I said earlier, it is the same field force that is detailing Optune Lua in the U.S. That team is, by effect, training and getting comfortable with the education around Tumor Treating Fields through the work that they're doing in their day jobs detailing Optune Lua.
I really do think that's one of the unique differentiators of this platform therapy, that we are able to leverage the value of the diverse product portfolio platform as we look to have two field teams detailing four products exiting next year with consistent customer sets and messages that do have a halo effect, we believe, across indication.
Yeah. You mentioned the PINOVA-4 trial in the metastatic setting in pancreatic cancer. That study is also including a checkpoint inhibitor in the regimen. Curious to get your thoughts on potential synergy there and how you kind of think about the market opportunity.
Yeah. I mean, we are very interested anytime we can combine with an IO. As I said, we've seen both preclinically and in our clinical data to date that Tumor Treating Fields trigger immunogenic cell death. We see the potential to turn cold tumors hot. We see this in our LUNAR data in the combination with ICI and metastatic non-small cell lung. We're exploring this today in GBM with the KEYNOTE D58 trial and then PINOVA-4. As you noted, we'll look at this in combination with atezolizumab. We need to see the data before we decide where we go from here. It's particularly interesting both in the brain and in the pancreas when we think about these are tumor microenvironments that have been privileged to IO before. IO has not shown an effect, they're cold tumors and there's, you know, challenging microenvironments just because of fibrosis or the blood-brain barrier.
The opportunity to use an electric field to stimulate the immune system where other systemic agents have not been able to do so is, I think, a story we'll be talking more and more about as we look ahead. We're excited to see that data, and we'll see where we take it once we have the data in hand. That is coming around the corner early next year.
Yeah. Curious if you could talk a bit about the next generation arrays, which you've launched in GBM. Maybe just briefly how that's going and also if you have plans to also launch a torso version of those arrays.
Thank you for the question because I think that is another element of being a medtech company in a biotech world. We get to not only advance the clinical pipeline and expand indications, but we get to actually work on the device itself and lower the device burden over time. That both provides durability from an IP perspective, but it also increases the patient experience and has the potential to mean that the survival benefits you see in your clinical trial only get better over time as you're able to actually deliver a better product to that patient. Our most recent innovation was a new array, which is the skin-facing part of our device in the head. It's much lighter, it's more flexible, and we are seeing and hearing just significant positive feedback from the patient that hopefully drives extended duration and usage over time.
We know that this is important in the torso as well. We are working on the next generation of the torso array. We're also working on the form factor of the device itself. I will say, you know, we're working on next generation, and then we also have a team already working on the leapfrog of that next generation if you just think about the development cycle over time. A lot of interesting news we think to come out over time.
Maybe to talk a bit about the last of the four indications. Brain metastases from non-small cell lung cancer. How does brain metastases, I guess, function different or similarly to GBM? Do you think having that kind of base business there will help you with that launch?
Yes. That's the short answer, right? The kind of the beauty of brain metastases is that, that's the wrong description of it, but it is the same customer that we know today. The radiation oncologist that is doing the SRS for the brain metastases for non-small cell lung cancer patients is the radiation oncologist that's treating glioblastoma (GBM). This is a customer that knows us, that knows not only Novocure and Tumor Treating Fields, but is also comfortable using devices to treat cancer. This is a sweet spot from a commercial uptake. Now that's the tailwind. The headwind is that we're treating the secondary tumor, and the current standard of care is watchful waiting. We have to do a little bit of market building now because post-SRS, there is nothing currently on the market that they're able to offer these patients.
What Optune Lua will do is it will open up a window of opportunity to treat that primary tumor because the metastases will be under control. We do think that is a message that will be very clinically meaningful, and we're looking forward to getting it to market.
Maybe just touch on where you are with the PMA submission based on the METIS trial, and I guess timelines for launch.
That's a modular submission. The first two modules are in. We've had our pre-submission meeting on the clinical module, and soon is the answer to where we are. We're in the final miles of preparing that package. As a result, we would expect to be launching back half of next year.
Okay. Great. Maybe to close out as a final question, just kind of sum up for us upcoming catalyst milestones that you're expecting for the next 12 months or so.
Yeah. I was reflecting on this, and it's quite a catalyst-rich story, I will say, as we look ahead. First, we have the continued just focus on execution in our GBM business and the ability to deliver that kind of mid-single-digit revenue growth there. We just announced that we got Spanish approval in August, and we do see an accelerant of top-line growth there with Spain coming on. As we look ahead, we're looking at the approval of the non-small cell lung cancer in Japan. We're looking at the submission of the metas package to the FDA. As we turn the corner into 2026, we'll have the readout of our PINOVA-4 trial early in the first half of next year.
Also, in the second half of next year, more likely the second quarter, we'll have the readout of our Trident trial, which is a randomized pivotal trial in newly diagnosed GBM, looking at an earlier start to Tumor Treating Fields treatment. That will take us through the first half, and we'll be looking at the launches. We'll be in launch mode for PANK and metas. As we look through the end of 2026, where again we'll exit the year, we believe with four indications, a diversified product portfolio, a commercial infrastructure that's already built, a go-to-market model that we know well, and a clear path to profitability. It's going to be an exciting six quarters.
All right. Yeah, looking forward to seeing all the updates. Thank you so much, Ashley. Thanks, everyone, for listening in. Hope you enjoy the rest of the conference.
Thanks, Emily.