Hello everyone. Thanks for joining us. My name's Jonathan Chang. I'm part of the Leerink Partners equity research team. It's my pleasure to host the management team of Novocure. We have with us today CEO Frank Leonard and CFO Christoph Brackmann. Thank you guys for joining us.
Thank you.
Thanks for having us.
Would you like to take a few minutes to briefly introduce the company?
Yeah, absolutely. Again, thank you for having us here. We always really appreciate the research from Leerink and the breadth of coverage that you've had on us for so many years. To introduce Novocure, we are a 25-year-old company that was founded on a unique insight that cancer cells have their own electrical properties different from healthy cells. We've carried that insight forward now into developing a standard of care treatment for glioblastoma, as well as an approved treatment for non-small cell lung cancer and most recently now a treatment for pancreatic cancer. It is a device-based treatment, as we can talk about through the presentation today, it is.
It's a little bit different for both patients and physicians to adopt it into their lives and their practices and, you know, we're excited that we're able to talk about so many approved indications now.
Great. Let's start with what's new, different, the same with you, Frank, as CEO since December?
Yes. Thank you. Yes. I took over as CEO in December, having been with the company since 2010. In some ways certain things haven't changed. Our mission remains the same. We know that Tumor Treating Fields, our therapy has broad applicability against cancer. We know that it's a very unique way of treating cancer using a physical approach as opposed to a biological approach. By, you know, through those, you know, through that fact, we have a really, you know, broad portfolio of data now showing our ability to treat cancer cells in vitro, in vivo, and in humans. In a big picture way, our mission hasn't changed. We still want to help cancer patients extend survival.
I think what will change and what we've already started to change is in how we focus as a company. I think, you know, when you're fortunate enough to have a cancer therapy that has a very minimal toxicity profile, high therapeutic index, you can start to go after a very wide range of tumors. What we've tried to do now is, you know, my background being more on the commercial side, is coming in to every new clinical development that we approach and asking the question of, "How do we actually turn this into a viable business?" Because at the end of the day, that's really what we're here to do, is if we have a great clinical trial outcome that has great scientific merit, we're happy.
If that doesn't translate over into thousands of patients being able to use the device successfully to treat their cancer, it's just not relevant. That's a bit of the shift in mindset that we've tried to bring to the teams over the last two months and I think we'll, you know, we can talk in detail more about that as we go through, but there's just a few things that we have to pivot in terms of how we do both our clinical development and then our commercial operations.
Got it. My next question was gonna be on more of the scientific and clinical arena in terms of where you could apply this device. Maybe just following up then on, you know, the way you just answered that question.
Yeah.
Where should the focus be beyond just this, where could it work? Where should the focus be for this device?
Yeah. Thank you. I mean, this is where I'm so excited. Again, as I mentioned before, our founder's core insight is that cancer cells have unique electrical properties. As one example, cancer cells, because of their leaky membranes, begin to accumulate calcium ions, which then inherently changes the transmembrane voltage potential difference from inside the cell to outside the cell. Cancer cells essentially sit much closer to a neutral charge between the inside and the outside of the cell versus healthy cells, which by extension then creates a very low ability for a cancer cell to absorb charges. That's kind of this unique insight that we started from. As I mentioned before, because that's a trait that's common among most cancer cells, it means we have this incredibly broad applicability.
What we're going to try to do over the next coming years is we think about how to narrow down where we should focus, because we know we can treat so many tumors, so the question is, where should we focus? What we wanna look at really are two core components from the therapy and one from the patient side. First is that we know we've had tremendous success in tumors that have a low bioavailability for drugs. This would be glioblastoma, for example, where the blood-brain barrier prevents most large molecules from getting to the brain, and by extension, prevents most chemotherapies from being effective in brain cancer. We see similar traits in pancreatic cancer, where we've recently launched because pancreatic tumors have stromal tissue that lower the bioavailability of drugs.
We're really excited. You know, we've built a durable business in GBM, and we're now excited to launch in pancreatic cancer because we think it fits squarely into the strength of our technology, where we can use a physical effect to overcome a biological limitation. We think that's important, not just from the ability for our product to be successful in trials, but when you're a physician who's been giving huge volumes of incredibly toxic chemotherapy to your patient for decades because that's the only way you think you can get a therapeutic benefit, there's an open mindset to bringing in a device in that situation.
Something that we've tried to talk a lot more about in recent, you know, months since I took over is where are we being pulled into the treatment paradigm versus where can we push this therapy in? I think when we can find these cancers, these tumors where the physicians are desperate for a non-biological approach, whether it's radiation or Tumor Treating Fields or now focused ultrasound, we see an emerging consensus that the physicians will say, "Okay, I need to get something else besides just what I have in my drug toolkit." A second area where we're really excited and we think we have the ability to bring unique benefits is around the use of immune checkpoint inhibitors in tumors where the response has not been as strong as desired to date.
These can be tumors, again, like glioblastoma or pancreatic cancer, where historically immune checkpoint inhibitors have just failed because the tumor's in a location that's either low bioavailability or even is immuno-protected. You know, we're really excited. We have our phase 3 trial in non-small cell lung cancer that showed a significant survival benefit where Tumor Treating Fields was used with the immune checkpoint inhibitor. We also have our phase 3 program now in glioblastoma, where we're using Tumor Treating Fields plus pembrolizumab. Even though pembrolizumab has historically failed in glioblastoma, you know, we think we have strong, early trial evidence that we may be able to drive that response. That's essentially all built off the fact that when you exert an enormous amount of physical stress on a cancer cell, the cell itself begins to trigger immune.
or trigger, I should say, stress responses, including ER stress, calreticulin upregulation, all of which make the tumor more visible to the immune system than it had been previously. Scientifically and clinically, we really wanna lean into development in tumors where there's, you know, low bioavailability and/or, but really and if it's possible, the ability to play off our upregulation of the immune response. Then lastly, something that's really, you know, increasingly an area of focus for us is that we need to focus on indications where the patient is highly motivated and healthy enough to complete therapy. Because I think historically we probably have not put enough effort into realizing that, you know, this is a device the patient has to wear.
Are we giving them a treatment protocol and regimen, that's something they can integrate into their life? Are they a patient who's still at that stage of being highly motivated to go and try everything?
Great. Trying to piece some of those pieces together, what are the tumor types beyond GBM and pancreatic? What are the tumor types and settings where you feel like, you know, the patient's pulling you in, and that this patient compliance, you know, fits together?
We are looking at certain tumors for our long-term development program, but what I would actually anchor back to is that today in glioblastoma, we are only penetrated in our established markets around the world. We're somewhere around a 40% penetration rate in those markets today. We think we have tremendous growth in GBM, and I think some of it will come from better execution and incremental data coming out. We also think in glioblastoma, we have these stepwise jumps coming from two phase 3 programs that we'll read out. One we'll read out this year, which is our TRIDENT study in using Tumor Treating Fields plus radiation. Then later on, we have our KEYNOTE-D58 study, which is Tumor Treating Fields with pembrolizumab.
I think within GBM alone, we see really strong areas for growth, and Christoph will talk more about these in a moment. Similarly, in pancreatic cancer, you know, there's a total of 60,000 pancreatic cancer cases each year. Our current indication in locally advanced pancreatic cancer is only 16,000 patients. Going back to this concept of trying to introduce more discipline into how we approach development, I think just within our existing indications, we have the ability to drive double-digit top-line growth for years to come, and I think we can be very, you know, targeted in how we do development in those tumors.
Understood. Maybe we'll start with GBM. What does the commercial picture look like today? You mentioned 40%.
Yeah.
Where do you see this going in the future?
Yeah. Maybe first with GBM, we have been commercializing GBM or GBM indication since about a decade, built essentially the standard of care with TT Fields. There hasn't been any meaningful innovation apart from us over the last decades. As per the end of December, we had more than 4,400 active patients on therapy, and revenue in 2025 tied to GBM was approximately $645 million. A very solid base. As Frank mentioned, we have about 40% penetration in our main markets. Now, that's well on the one hand has proven to be somewhat of a sticky plateu over the last couple of years. On the other hand, we also intend to drive further growth.
We intend to grow, drive growth through just commercial focus, but then also innovation on both the clinical side as well as on the product development side. 2025 was a year of particularly strong growth. We had 9% active patient growth. We don't expect that to repeat this year. What we guided to was growth in GBM of low- to mid-single digits.
All right. Tell us about the TRIDENT study that you mentioned. This is a newl diagnosed GBM, and we're expecting top-line data in the second quarter.
Yeah.
How could this help bolster the opportunity in GBM?
Excellent. Yeah. To just set the stage with TRIDENT. TRIDENT is a 950-patient randomized controlled trial for newly diagnosed glioblastoma, where Tumor Treating Fields is featured as the standard of care on both arms, both the active arm and the control arm. In the active arm, Tumor Treating Fields will be introduced at the same time that radiation therapy is started following surgery. For the control arm, Tumor Treating Fields will be implemented after the completion of chemoradiation, which is typically about six weeks of therapy. The trial is really, it's set up to study, to build off of, preclinical insights as well as pilot studies in this same area, where we've shown that Tumor Treating Fields has a noticeable effect on delaying DNA damage repair.
We think that when we add Tumor Treating Fields on top of ionizing radiation, we can have the ability to make the ionizing radiation more effective in addition to delivering our normal cytotoxic effect. You know, I referenced that we've seen this in pilot studies in glioblastoma, but it's also something that we've observed in metastatic non-small cell lung cancer, where we showed that in our METIS trial, the addition of Tumor Treating Fields on top of stereotactic radiosurgery led to a doubling of the disease control rate intracranially, basically keeping the tumors at bay, versus just doing the radiation therapy alone. We have a lot of emerging evidence to say Tumor Treating Fields plus radiation may have a strong benefit for the patients.
Now this trial, what I would highlight is for those who have followed Novocure for years, I do need to highlight that the trial is different from the EF-14 trial that is our current basis for approval in glioblastoma. In EF-14, the patients were not randomized and selected into the trial until they had completed chemoradiation as a stable patient. Again, TRIDENT is all comers with GBM randomized at the time of surgery to either start tumor treating fields with radiation or to wait until the completion of radiation. This trial, I think, you know, why it's really exciting for us, one, is that for the first time, we can access the full patient population within GBM. We're not limited to the patients who have been stable after chemoradiation. That should add about 25% of the patient population.
The second is we're starting the therapy earlier, so if the trial is successful, this would help us to extend the duration of patients on therapy. You know, overall, I think it's for patients with glioblastoma who, as Christoph mentioned, haven't really had any advances over the last, you know, decade plus. This is a really interesting way to not have to layer in another set of toxic treatments and yet potentially just through a, you know, better rationalization of when you get the existing treatments, can you drive better survival?
Got it. Have you guys commented on how much this could expand the opportunity, you think, for Tumor Treating Fields in GBM?
Well, we do think. You know, we've always talked about, and this is true for the EF-14 trial, it's about 25% of the patients who can't make it through the full chemoradiation phase, so obviously they won't be on treatment for extremely long periods of time. We do think it would be a 25% larger patient population that could be eligible.
Understood. How about touching now on pancreatic cancer, that Tumor Treating Fields is now approved as Optune PANOVA for the treatment of locally advanced pancreatic cancer. How should we think about the early launch in this setting, and how should we be thinking about the longer term commercial opportunity in pancreatic cancer?
Yeah. Actually, Christoph, do you wanna take the longer term, and I'll touch on-
Yeah. From a, I mean, longer term perspective, maybe just to talk a little about the TAM. There's about 60,000 patients being diagnosed on a yearly basis with PDAC, and we have approval in the locally advanced setting, which is about a third of that. We conservatively estimate a TAM of around 15,000 patients a year. Which roughly speaking is about 50% larger than what we have in the GBM indication.
Yes. I think, you know, going back to something we were talking about earlier about the patients, patient population here, I would highlight this is—it's a first line therapy in locally advanced, so these are relatively healthy patients. Actually, these patients typically present with or hard to describe GI symptoms, maybe a little bit of fatigue, having trouble sleeping at night, not eating as well. But overall, they're pretty healthy, and they are highly motivated patients. I think, you know, what we've seen so far in the first few weeks of the launch is the patients, the patient advocacy community are aggressively reaching out to doctors, asking for the therapy. Doctors are reaching out to us to become certified and trained on the therapy so that they can start prescribing.
It really does, I think, fit neatly with the picture that I was trying to paint earlier, that the doctors know they haven't had any other advances in the last decade plus in pancreatic cancer. There's a strong rationale for using a physical therapy. In addition to the overall survival benefit that we demonstrated, we showed a six-month improvement in pain-free survival, which, you know, when you talk to a lot of the GI oncologists, they will say that the number one thing they want to do is to knock down the pain for the pancreatic cancer patient. That endpoint has really resonated as being meaningful.
We're very excited, you know, and I think as I alluded to earlier, you know, we really do between GBM and pancreatic cancer, we see those two indications as our ability to drive growth in active patients, but ultimately into double-digit revenue growth.
Understood. Are there learnings from the GBM commercial experience that you can apply to the pancreatic cancer launch?
There are both learnings from GBM as well as from our launch in non-small cell lung cancer.
Okay.
I think, you know, it's two sides of the same coin. I think with glioblastoma, we were accepting all of the patients that the physicians were sending to us, and that reduced the burden on the physician to try to select, you know, exactly is it this, is this the right patient or is that the right patient. Whereas with non-small cell lung cancer, you know, we were a little bit more prescriptive of making recommendations around, you should look for healthy patients, you should look for patients who can really manage this disease, this disease plus this therapy.
Whereas with our launch in pancreatic cancer, given the motivation of the patients and given the fact that the physicians are eager to get started, you know, we're really trying to make this as easy as possible for physicians to prescribe. We're leaning into the use of our HCP portal so that the physicians are able to e-submit digital prescriptions. You know, we're not trying to contain it to a specific subset of patients who we think will do the best. By extension, we're just making sure that we have the full capabilities of our support services available to make the patient successful.
Understood.
Maybe just to add one thing that is not related to the indication of the data itself that we have, but more to the fact of when we launched lung, we built a new field force next to our GBM field force, which was in essence nascent to TT Fields, right? We are now using that field force and are basically promoting pancreatic cancer. We have a field force that's fully trained on the therapy, which is a bit of an advantage as well.
It is. It's actually a fantastic point, and it's one I would love to double down and just say that we, you know, we really are now in this world where we are multi-indication, and while we've been disappointed in how our lung launch has progressed, it does mean we have this fully trained field force that's out in the field. We're starting to see these leverage points where it could be there's the CNS radiation oncologist who's treating brain mets, who's willing to make the referral back to the oncologist, who's treating lung disease, who's also willing to make the introduction to the doctor who's treating pancreatic cancer.
you know, we've certified so many sites for lung cancer where we can walk right in, we can walk back in now and ask for the certification of the GI doctor. Just starting to see that early benefits of being a multi-indication oncology company.
Understood. How are you thinking about the evolution of the pancreatic cancer landscape with the potential introduction of KRAS inhibitors? How does that impact your strategy with your device?
I think first, you know, first we do acknowledge we are happy to see the progress that the KRAS, the class of drugs for KRAS that are developing. We're happy to see that progress. I mean, we know there's more to be done for pancreatic cancer patients. I think number one, in terms of our strategy as the first to market, the first branded product to market, and also the first, you know, we really are unique in our label in locally advanced pancreatic cancer, where most of KRAS development has been metastatic and then jumping to adjuvant. We are very pleased with our label and our ability to really own that space. I think number one in our strategy is to launch as quickly as possible and to really launch, you know, successfully.
I've mentioned this before, but in my first few, you know, weeks as CEO, one of the things we did was we pivoted our resources out of our marketing budget for lung cancer and into supporting the pancreatic launch. I think one is we need to get into as many practices as we can and really establish ourselves as a part of this indication. From there, we're looking creatively at how we can open trials with the KRAS inhibitors, either before they come to market or after they come to market. Those discussions are ongoing with our peers in the industry, and we're hoping, you know, over the coming months that we'll be able to talk more about that.
The good news is, Tumor Treating Fields has to date not heightened adverse events when used with any other product. You know, for anybody who's completely de novo to Tumor Treating Fields, it's always important to note this is our therapy really, the only adverse event that's been consistently shown is a skin irritation. We don't have that sort of cumulative toxicity that you see when you stack drugs on top of each other. We're really excited to work with the KRAS inhibitors to find the right way to stack the treatments, because even in the best case scenario, where KRAS inhibitors are showing these really strong disease control rates, when you peel back the numbers, there's a big portion of the disease control rate that's stable disease.
If you could imagine being a metastatic pancreatic cancer patient, you have stable disease, you're still in an extraordinary amount of pain and you're not happy. I think that population, you know, is really a window where it's either the patients who start a KRAS and then can't continue or they start a KRAS and they don't have a response.
Right.
That's a huge chunk of this very large population. You know, we're excited for patients, but we're also very, you know, very committed to the indication because we do see a clear lane for success.
Got it. Can you talk about the patient experience in pancreatic cancer? Tell us a bit more about the degree and rate of rash and what the compliance pictures look like so far.
Well, for us, in terms of, our therapy and our clinical trials in, the PANOVA-3 trial, which is what led to our approval in locally advanced pancreatic cancer, we did not see any increase in skin irritation. Now, this was with a gemcitabine nab-paclitaxel backbone therapy. And so there wasn't any reason to think that we would have that overlapping, toxicity with, from a skin perspective between the medical therapies and our therapy. So we're really pleased with the adverse event profile that we have in pancreatic cancer right now. I'll just also highlight, you know, we have our PANOVA-4, phase 2 trial that will read out in the coming weeks. This will be another chance for us to look for meaningful data in pancreatic cancer that we can use to build our portfolio going forward.
The PANOVA-4 study is actually now in metastatic pancreatic cancer, and in that indication, we're using tumor treating fields plus nab-paclitaxel, gemcitabine, and then adding atezolizumab, which would then squarely bring, you know, this trial into that sweet spot where we have both a tumor that we're giving a physical treatment to, where the biological treatments have failed, but also potentially showing that we can make a tumor respond to an immune checkpoint inhibitor when it has not historically.
Got it.
Yeah. Quite excited. If you look over the horizon, I think you're also implying with KRAS inhibitors, how will we deal with skin irritation? We have a couple of pathways forward there. You know, one is just simply the fact that as the KRAS inhibitors become more targeted, the skin irritation does seem to be coming down, so we're gonna monitor that avenue. The other avenue that we have that we haven't you know talked a lot about historically is having better treatment protocols for Tumor Treating Fields where you know historically we've said wear it as much as possible for as long as possible.
Well, if you're a patient who's actually getting a fairly effective systemic therapy, we can start looking at taking that down and saying, "Maybe we're doing this 12 hours a day for three months at a time, and then we'll start it again if you have a progression." We're gonna be more creating going forward about making the protocols easier for patients to use.
Understood. Maybe just on PANOVA-4.
with an update expected in the coming weeks, what could investors learn in that update and how might PANOVA-4 expand and change the opportunity for the device?
I think in terms of just the headline, we'll provide the headline data from the trial, not the full data readout in the coming weeks. It's, as always, a top-line data release in the press release with the publication to follow. I think, you know, we won't immediately jump to talking about what comes next in our clinical program because it is this dynamic environment where we're, you know, we're talking to the KRAS companies. We're going to look at our data and see what we think an immune checkpoint inhibitor could bring into pancreatic cancer. We would likely give an upgraded clinical development pipeline for pancreatic cancer sometime later this year. It's not gonna come all at once with the readout from this trial.
Understood. Maybe just in our remaining time, we'll touch on how should we be thinking about lung cancer at this point in time? You mentioned, of course.
Yeah
... the priorities of the company since with you now as CEO. How should investors be thinking about what's next for lung?
Actually, Christoph, if you could just touch on our vision from a, you know, sort of revenue guidance top line, and I'll come back to the strategy.
Yeah. From a higher level perspective, on top line guidance that we gave in our Q4 call was we expect revenue this year of $675 million-$705 million. That is primarily driven by GBM. The other growth driver that we have is coming from new indications, and what we said is we would expect $15 million-$25 million from new indications. That includes Optune Lua as well as Optune Pax, versus we did $10 million last year. $10 million last year, and we expect $15 million-$25 million this year. Now, the primary growth driver on lung, we would expect to be Japan, where we basically just received reimbursement and launched as well, in a commercial setting. Yeah, that's from a big picture perspective.
In the US, we don't expect the, let's say, commercial dynamics to change significantly to what we have seen last year.
If I look out longer term, the way that we're thinking about building Novocure is that we have between GBM and pancreatic cancer, the ability to drive double-digit revenue growth for years to come, including, you know, just including first on our approved indications, but also as we stack new clinical data into the, into the paradigm. From there, we have to look at the lung program as something where we've generated significant and meaningful clinical data to date, but we need to invest in it going forward in a way that really recognizes can we make this commercially viable. There'll be more to come on this front, but we've already talked about the fact that we have a LUNAR-2 trial right now, which is a phase 3 trial in stage 4 non-small cell lung cancer.
It's quite an extensive investment, you know, and we need to look at that in terms of can we, you know, how do we look at that in light of the fact that we have such a strong opportunity in GBM and panc? It could be that in lung cancer we find a slightly different population where they are healthier, highly motivated, and have physicians who are really pulling us in.
Understood. Just in our remaining time, last question from me. How should we be thinking about the road to profitability for Novocure?
Since we have 20 seconds left, I'll be very disciplined in the answer, and it's discipline. It's that we know we have revenue growth ahead of us. We have the ability to grow GBM. As reimbursement comes on for pancreatic cancer, we could really have meaningful revenue growth next year. And then we just need to be more disciplined on the operating side where, you know, our R&D spending in particular has grown every year for the last several years, but the output hasn't been. You know, we think we have that path over the next two to three years to get there.
Maybe just to briefly add to this is, over the last years, we basically put the infrastructure in place to now launch in the multi-indication setting. From an investment perspective, there's really very incremental investments required only to drive, the multi-indication and the growth to come.
Understood. Thank you guys very much for joining us.
Thank you.
Thank you.