All right, when we get started, thanks everyone for joining here today. I'm Jason Bednar. I cover med tech here at Piper. Our next fireside chat is with NovoCure. Very happy to have with us today Executive Chairman, Bill Doyle. Also have, Head of IR, Adam Daney, in the audience here. Thanks a lot for being here, Bill. You know, always good to catch up with you at our conference. A lot of different topics to cover with the business. We do have some recent news that we can probably just kick things off with. You announced the CEO change yesterday, yesterday morning. What maybe let's start there. What drove the need to change the seat at the top?
First, Jason, thanks for having me again. It's always a pleasure to come here in December. We're looking at one of the most exciting years in the history of NovoCure. And just to remind everybody in the audience, I've been involved in NovoCure, not day one, but day two, and have worked to bring the technology from the basement of a professor in Israel, through all the preclinical development, into our first successful phase three trials in glioblastoma, and then to build an international business that is the foundation of the company and the driver of our cash flow today, and really the foundation that we're building on in the future. We are poised at a moment today where we're doing something that very few companies do.
We're taking the company from a single product, single indication, to really leverage the value of the platform by treating many, many more patients with different kinds of cancer. We're also doing this internationally. Today, our business is in 16 countries. We're confident that we can do this, but I don't want anybody to think that this is easy. At the board of directors, we're continuously evaluating what's the best combination of talent within leadership, particularly, to accomplish our mission. As we will talk about, we're really considering what we wanted to accomplish in 2026. We determined that, you know, first of all, we were fortunate that we had great talent within the company.
One of the things that we were focused on and remain focused on as part of this transition, I will talk about transitioning to a multi-indication company, but also transitioning from a company that was not profitable to a company that will be EBITDA break-even and profitable. In planning for that transition at the board, we thought that Ashley Cordova, who is our longtime CFO, tremendous contributor to the NovoCure that we see today, was the best person to engineer and design that transition. She had an unparalleled grasp of where we were spending money, how we were getting value. As we began to look into 2026, where really the execution now is paramount compared to the planning.
Frank Leonard, who has also been involved in the company for 20+ years, and is the person who built our reimbursement engine, built our commercial engine in the U.S., unlocked our commercial capabilities internationally, and really had the feel of the customers in hand, was the best person to lead the execution. You know, the one thing I want to emphasize is that nothing has changed, nothing has changed about what we intend to accomplish and what we've committed to accomplish. What we're trying to optimize is the how. Frank, with his long experience in the commercial product development and reimbursement, having touched and built most of those teams, we determined was the best person to take us into 2026 to execute the plan.
Okay. That is really helpful. It does not sound like there is a whole lot that we are going to see changing from our seat, at least with respect to how we think about NovoCure, with respect to the regulatory milestones you have out there, the clinical development, clinical milestones, the commercial strategy, profitability. All of that sounds like it is staying the same.
Exactly.
What changes maybe under Frank that we're going to see from our side?
I think you from the outside looking in will see very little because it's just as you described. The regulatory timelines, the commitment to launches, the commitment to driving the GBM business, none of that has changed. What I think changes on the inside are some subtle changes in how capital is allocated, some subtle changes about how the teams are organized. I think from the outside, the way I would think about it, the probability that we'll do everything that we said we were going to do, you should think about that as going up under Frank's leadership.
Okay. Maybe if I can push harder on one of those points, like, what is Frank going to do? I mean, how, if you can talk about it, yeah, maybe it's still in motion, but where is he going to spend dollars differently? Where is he going to spend resources differently?
Yeah, I think it's too early for us to, you know, describe anything specifically, but he obviously has his fingers on the pulse of the launches.
Okay.
He's the one who's in with the KOLs and understands where the good recruiting centers are, where the, you know, the recruiting centers that, you know, may never recruit. He has that knowledge. And, you know, I'll give a couple of specific examples. In 2023, or leading up to 2023, Frank had responsibility for product development and really unlocking product development. I think you're going to see the benefits of that unlock in the near and in midterm. We asked him to take a look at our U.S. organization, which, you know, organizations, you know, with all the management in the world, they tend to evolve to. Our organization was looking top-heavy. I hate to say this. It was looking pharma-like, you know, global this, global that, you know, a lot of management functions.
Frank went into that business, took $60 million out of the spend, and then in 2024, we grew the business by $100 million after having taken $60 million out. We then asked Frank, in addition to that, to take over the international businesses. Leading up to Frank's transition into leadership, we ran the company as a U.S. and rest of the world. Rest of the world, all being sort of top-down driven. Frank unlocked that, drove decision-making and responsibility to Japan, Germany, France, and then rest of the world. That has resulted in the double-digit growth that we've seen in GBM in the international markets that has really driven our performance, our revenue performance in 2025. Frank Leonard having specifically unlocked the potential of the management in those markets. That's what we're looking for.
This is not about, you know, some radical change. In fact, it's not about change in objectives at all. It's about management optimization and execution.
Okay. Great. I do kind of almost led off the session here saying 2026 is going to be a big year. I want to talk about a lot of what could make 2026 a very big year because I agree with you. Maybe we'll first start with pancreatic cancer. You have your PMA submission, you have the package is in play. Have you had any dialogue with the FDA since that submission? Anything that developed during the government shutdown? Is the ball still moving forward? Anything you can respond to there?
Yeah. So what I can say is that that submission is moving as planned and as expected. There's no surprises. We are a fee-paying entity, so the government shutdown did not affect us explicitly. We proceeded to work with the FDA throughout that process. This is an approval that is based on our PANOVA-3 trial. And for those of you who follow the company, this was a very simply designed study, very clear overall survival input, an indication where there's tremendous unmet need. The FDA has been treating us, I would say, consistently with respect to those characteristics. We anticipate approval. We anticipate to be in a position to launch the day of the approval, and we'll be in the market in the U.S., treating patients just as soon as we can.
Remind us of the 100-day marker. When do we pass that point? I know we didn't have an adcom with the lung indication, the non-small cell lung indication, but we should expect something similar here. No adcom is necessary.
Yeah. So we've only had one adcom in our history, and that was with our very first indication, our EF-11 and recurrent GBM. Since that time, we've never had an adcom. You know, the FDA can do anything they want at any time, but if we were going to have an adcom, we would know by now. So, you know, I would not expect that.
Okay. All right. Just real quick, timelines outside the U.S. with respect to pancreatic cancer, you know, the filing and securing approval in Europe or EU and also in Japan.
Yeah. Those are in the works. You know, the U.S. will be first and will launch here, and then it'll be followed by the European Union and Japan. You know, the unmet need is the same in those markets, but we're sequenced to move first in the U.S.
Okay. Staying in pancreatic, but it's a little more clinical. PANOVA-4, this is a, for those in the room, this is a phase II in combination with Tecentriq for patients with metastatic pancreatic cancer. I think we're right now scheduled to get that data first half of next year, or earlier in that first half, at least sequencing relative to TRIDENT, which we'll get to in a second.
Yeah.
Have you seen the PANOVA-4 data yet?
I have not.
Okay. All right.
Just, you know, I'll frame this in for folks. Pancreatic cancer is diagnosed in one of three stages typically. The minority, maybe less than 10%, are diagnosed early when the disease is resectable. The second group is called locally advanced. This is when the disease is diagnosed but has only spread locally, in the peritoneal area. Then the third group is the metastatic group where it's diagnosed later and it has spread more extensively. Our PANOVA-3 trial was treating that middle group where we're surrounding the whole cancer. That's what we expect—excuse me, Jason—that's what we expect approval for in the near term. PANOVA-4 treats that third group. Importantly, we're treating it with a checkpoint inhibitor. This is Roche's checkpoint inhibitor.
The promise here is that by treating the local disease with Tumor Treating Fields where we create immunogenic cell death, we can now expose the immune system and the checkpoint inhibitor can go to work systemically. Checkpoint inhibitors as single agents have not been effective in pancreatic cancer, just like they were not effective in GBM. When we combined Optune with Keytruda in GBM, we saw these fabulous, phase II data, and that's the basis of P58, our phase III trial. You know, best cases, we would see something similar, which would be a much better result compared to historic data in the systemic disease. That, you know, is clearly a tailwind in our efforts in pancreatic cancer.
Okay. If PANOVA-4 is successful, let's fast forward and we get the readout. The data looks good. We have that good or best case scenario. What should investors expect as next steps after PANOVA-4? How are you thinking about that?
Yeah. We have to look at the data, obviously. And, you know, if I were to bracket it, it's a great tailwind for our launch efforts in PANOVA-3. And, could it be registrational? You know, could we expand the label? You know, I don't know the answer to that question, but if it's fabulous data, huge unmet need, we could look at that. The more likely scenario is another randomized trial.
Okay. Phase III.
Of some sort. How big that would have to be, you know, we would look at all those options, whether we can just add the data to the existing label or whether we would need to do a phase three.
Okay. Shifting over to TRIDENT. Really interesting trial. I think real interesting potential for an already established indication that you have. Just to level set everyone, in this trial, you're starting TTFields treatment effectively two months earlier in conjunction with radiotherapy, whereas the current label is starting TTFields treatment after radiotherapy, radiosurgery. I think you have the opportunity to capture more patients, and you also have the opportunity to treat patients longer. With that preamble, what do you see as the bigger maybe revenue opportunity? I know you do not think about this as revenue because this is all about, you know, extending lives for patients, but from a revenue opportunity, is it treating more patients or is it treating the same patients that you already have but for longer?
It is both. Let me, you know, build on what you said here and remind everyone that the patient journey for a patient with glioblastoma starts most frequently with a seizure, an MRI, and then they go to surgery. At this point, you know, and I don't mean this the wrong way, but now there's a baton. The baton starts with the neurosurgeon. He passes the baton to the radiation oncologist who gives 8-12 weeks of chemoradiation and then passes the baton to the medical oncologist or the neurooncologist. Virtually all GBM trials, including our foundational trial, start after the radiation oncology, after that two to three months. We see whether we can improve survival, which of course we have the best data from that point. About 25%, it's a big number of GBM patients, crash during radiation therapy.
They never make it to the point where they can start Optune or other drug therapies that have been prescribed after radiation. As you described, TRIDENT adds Optune right at the beginning of radiation. That gives us the opportunity to treat those patients for another two to three months. Again, because we get paid by the month, bringing it to revenue, that's an extra two to three months for the patients that we would get anyway. Presumably, if it's successful, that means they're better long-term survival, so some number of months on the back end of therapy. That's one. Two is that 25% of patients who would crash through radiation, we now get those. The actual TAM increases by about 25%.
Now, I don't know what the life expectancy of those sickest patients will be, but we can start treating them and hopefully we can make a meaningful improvement in their expectancy. Then the third benefit, I'll go back to my baton analogy. The doctor holding the baton is now the radiation oncologist for the start of treatment. They are our best prescribers. They're the prescribers who understand physics. They're the prescribers who understand device-based therapies. They're the prescribers who understand the synergy between radiation, ionizing radiation, and electric field therapy. Just having that prescribing decision in that group's hands, we believe, is going to expand the patient population. The revenue tailwind comes from those three possibilities.
Sure. Okay. It totally makes sense. A couple other, call it, dovetail questions off this. Have you figured out what the regulatory path is going to look like for TRIDENT? Is this a PMA supplement or?
Yes. This would be a PMA supplement. We would want to get these data on our existing indication.
Okay. And then off of that, do we need that PMA supplement to be secured before payers start paying for it?
You know, so that's always a, you know, a nuanced question. My belief is that for the private pay market, the answer is no.
Okay.
That we would start billing right away. Medicare is always, you know, a different, a different story. Medicare, we do have to show that the patients are on label, to get paid. I would expect Medicare to require the, you know, the label expansion.
Okay. All right. Fair enough. Why don't we shift over to the GBM business, even bringing in some of what you were referencing earlier with some of Frank's efforts. The GBM opportunity in Spain, I think you expect the ramp up there. You're not in Spain yet. You're going to be launching, you're kind of launching real time. I think you said the ramp is going to be more like a Japan where it occurs linearly over maybe, say, a few years versus like the really quick uptake that we saw in France. France was extremely successful. You almost got to like, I don't want to say peak penetration, but comparable penetration.
Yes.
almost in a span of like 18 months.
Yeah.
Why is Spain more like Japan, not like France?
First of all, we're going to do everything we can to make Spain happen as quickly as possible. The specific reason is that while we were delighted to get national reimbursement, and quite frankly, it was unexpected. You know, it was really driven by the clinical community in Spain. You still have to go and contract with each hospital to get paid. That's just a paperwork process, but it does take some time. Japan and France, it's a switch. You know, it's a national switch. In Spain, again, we have to do this administrative process that, you know, I think the way to for the modelers, I think, you know, modeling that over two years. We expect peak there to be, you know, we'd say half France is a good ballpark.
Which international markets? There are several that I know have come up over the past couple of years: Italy, U.K., Canada, Australia. I'm sure I'm missing a few, but those are usually the ones that I have top of mind.
Yeah.
What's next after Spain?
You know, Italy, I think, and Italy is regional. You know, I think northern Italy, where we're already active. I think, you know, coming off of the success in Spain, I think we would want to continue to drive northern Italy. Canada is also a regional market, you know, province by province. I think the far west coast of Canada, so, you know, British Columbia, is promising for us. When we talk about international, and I know, you know, the clock is always ticking in these meetings, I think an area where, you know, if you're thinking about revenue, we're really hoping to move. This is on the back of what we've said has been a harder launch in lung, in the U.S. for a number of specific reasons.
We have some hope that Japan, because it has some very different dynamics than the U.S. in lung cancer, we're expecting reimbursement there in 2026, hopefully earlier rather than later. We would launch lung then in Japan. Why do I say lung is different? First of all, the prevalence of lung cancer in Japan is much greater than the U.S. The Japanese still smoke more. Secondly, the standard of care in Japan is to continue the checkpoint inhibitor into the second line. Here, that's done sometimes, but it's not, I wouldn't call it the standard of care. You'll recall our data, our current data set is in, you know, after platinum failure, and the best data is with the checkpoint inhibitor. It fits better. I would say more like France. It's a very top-down medical community.
When we look at our LUNAR-4 clinical trial, the KOLs that are recruiting that trial and are engaged are the KOLs that drive opinion in Japan. I think the setup there, you know, an international market, a different indication than GBM. GBM continues also to do very well in Japan. We've got a great team, so that's maybe where I would focus international in addition to continuing the momentum in GBM next year.
Okay. Staying on lung real quick, one question here and then I'll follow up more broad. I think we've all heard that, you know, heard you loud and clear, lung's been more challenging than expected. I think the street's somewhere $35 million- $40 million in revenue for next year is for, I think, total total lung for the company. Is that a comfortable place for us to be?
You know, I'm going to leave the details of the revenue targets to Adam.
Okay.
You know, for those of you who want the best company guidance, because I don't know what we've said publicly.
I'm going to track down Adam immediately after this. You know, last question. This has been a very helpful session. Just to, as we look forward, I think you do typically pre-announce at, you know, early in January. Is that, should I say, is that the typical expectation or should we expect that again here, as we look ahead to next month?
Yeah. We'll be at JP Morgan, of course. I wish Frank were in the seat with me here. He's in Switzerland right now leading an internal leadership meeting that we have every year. He'll be front and center at JP Morgan. You'll all get a chance to meet him here. I would expect the pre-announcement that we can talk about there.
Okay. Perfect. We are out of time. Great session as always, Bill. Great to have you here. Thanks everyone for joining us today.
Thank you, Jason.
Thanks.