All right. I think it's officially good afternoon. I'm Jason Bednar. I cover MedTech here at Piper. Next fireside chat is with Novocure. Very happy to have with us today Executive Chairman Bill Doyle. Thanks a lot for being here, Bill. Really appreciate it, and you've got a little bit to talk about, I guess. You had some big news here earlier this week. Your PANOVA-3 trial hit the primary endpoint. Maybe let's just start there. It's just kind of a natural and obvious place to start. Can you talk about what investors should expect from, say, a timeline perspective? Now that you actually have primary endpoint out there, you've got data in hand, what are the major milestones going forward that we should be focused on in terms of medical conference presentation, regulatory submission in your major markets, and then eventually approval? Sure. So first, thank you very much for having me and having Novocure. And thanks to everyone in the room and online. It has been a really great year for Novocure. And in particular, with the announcement that we made on Monday that the PANOVA-3 trial in first-line pancreatic cancer hit the primary endpoint. This is a population that has really had nothing new in decades. And in fact, PANOVA-3 is the first phase 3 trial ever to hit the primary endpoint in this non-resectable, locally advanced pancreatic cancer population. So we are eager now to get this therapy to the patients who need it. And to your question about timeline, the first step was to get the data together and cleaned up to the point where we could announce the top line confidently. And that's what we did on Monday. The next step is to continue with that data cleansing and assembly and to create the regulatory submissions. This is a lot of work, and this will go into the FDA, to the notified bodies in Europe, as well as the PMDA in Japan, and those are the three filings that we're focused on first. We give generic advice that you should expect about six months for that process. Of course, we do everything we can internally to beat that, but I don't want to underestimate how much work it is to create a PMA file. In parallel with that, we're preparing the full data set for presentation to the scientific community. And of course, that's always, I know, the tension for investors because on the one hand, we do want to get the top line, did it work or did it not work, out to investors as quickly as we can. But we also need to preserve the bulk of the news, if you will, so that we are assured a prominent position in an important medical conference. We would expect that in the first half of 2026. We don't know which one it's going to be yet because we have to assemble and file. But success in an important phase 3 trial, I think we would anticipate a podium presentation at an important conference. In parallel with that, the ideal scenario is to also obtain publication in an important peer-reviewed journal. So in a perfect world, we would synchronize those. But in parallel, we're also preparing then the manuscript for submission. I think in all three of these, so regulatory filing, submission for prominent conference presentation, and prominent peer-reviewed publication, it's the same work, right? It's preparing the data. And in this case, because number one, it's a patient population that's important, two, where there's been little progress, and three, where the clinical trial was straightforward, one-to-one randomization, hit the primary endpoint, which was overall survival, with a strong p-value. All of those factors, I think, argue well for us achieving all of those milestones next year. The last milestone is then, of course, the regulatory approval. Again, the generic answer to the PMA approval process at the FDA is about a year. The statutory clock is 180 days for the first response. We'll do everything we can to work with the agency in order to make that on the shorter side. But I think for those of you who are plugging numbers into a model, I would plug in six months to file and 12 months to approval, which means we can be confident of approval in mid-2026. OK. And I know we're getting way ahead of ourselves, but approval launch second half of 2026. Approval mid, I don't want to change what you said. Approval mid but launch shortly thereafter. I think just as we did with our recent launch in non-small cell lung cancer, we launched the day we received the marketing approval from the FDA. I would expect the same thing, that we'll do all the work necessary to be in a position to launch. We will start the pre-launch activities well before the actual approval. I think you can expect pre-launch activities end of this year, early next year. We'll launch as soon as we receive the PMA. OK. Fair enough. Terrible cancer, which is why I know there's so much excitement about this. We'll get into whether or not how much two months matters because I know it matters a lot. But first, just before we drill down, stay high level, the TAM opportunity here that you have in front of you for the specific indication label you're going after. Sure. So what's important to remember in medtech reimbursement is that we're reimbursed on label and we're not reimbursed off label, general rule. So even though we are already getting interest in lung and interest in pancreatic to go beyond the label, you should think about reimbursement on label. In pancreatic cancer, patients are diagnosed basically in one of three buckets. Only 10% or even less than 10% are diagnosed at a point where the cancer is resectable. From there, about 30% are diagnosed in a stage which is called unresectable, locally advanced. That's where we performed our trial. So that's about 30% of the total. And the remaining 60%, excuse me, are considered metastatic at the time of diagnosis. So if we start with 30% of the total diagnoses and then we work our way back, that equates to a conservative number of about a TAM of about 15,000 for us on day one on label. Right, which is roughly, not specifically, roughly twice the size of your current GBM TAM. Is that correct? Yeah. That's a good round number. OK, so on that metastatic question, that's even a bigger opportunity, twice the size of what we just talked about. You have PANOVA-4, phase 2 trial looking at metastatic pancreatic cancer. How does PANOVA-3 inform your view now on PANOVA-4? One of the things that we've learned over the years in developing Tumor Treating Fields therapy is that when we combine, first of all, the therapy is a so-called loco regional therapy, right? So we put the patches on the region of the body where the tumor exists, and we create an electric field in a region. When we treat with chemotherapies, we can treat regional cancers very well. So that's in the case of GBM, which is a cancer in the brain, we treat very well. That's why we chose this non-metastatic patient population for pancreatic. What's tremendously exciting about the future and what we have learned since in both our research efforts, but we saw in spades in our LUNAR trial, is that when we combine Tumor Treating Fields with immunotherapies, we see a systemic benefit. And that's because we take advantage of another mechanism of action. And that's the fact that when we kill these cancer cells, we do so in what's called an immunogenic fashion. So we're exposing the immune system to the antigens, which allows the immunotherapies to work so well. So again, going back to the LUNAR trial, in patients after they had failed first-line therapy, we treated with Tumor Treating Fields and immunotherapy. Our data in that line were as good as immunotherapy in the first line, immunotherapy alone in the first line. So that leads us to PANOVA-4. So PANOVA-4 is a large, single-arm, phase 2 trial in that metastatic population where we're combining Tumor Treating Fields with Roche's atezolizumab, their IO. We've completed enrollment of that trial earlier this year. And we would expect the top-line data from that trial in early 2026. And so we're very eager to see those data. As I said, it's a large patient population. While it's phase 2, we know if there is ever a cancer where you can create a virtual control, it's in metastatic pancreatic cancer. And ultimately, I think the data will tell, but that would be the paradigm that I would imagine will be useful across the full spread of the diagnoses. OK. We spent a lot of time with PANOVA-3, rightly so. One more question for me on the topic. I kind of alluded to it earlier. Is two months of survival extension enough to really compel adoption or physician usage? That's kind of one part of the question. And then I believe there is, but I don't want to lead you down this path unless it's true. But is there a chance where the median overall survival could actually tick higher as this data continues to be seasoned? Yeah. So let me answer your first question, but it almost doesn't matter what I think. It's what the clinicians with whom we're speaking think. And we're hearing an unequivocal yes. Keep in mind the benefit from the chemotherapies, the highly toxic chemotherapies that are used in this line, is about the same, OK? So if you want to think of it that way, we're doubling the benefit of the chemotherapy. We aspire to maximizing the benefit for all patients. Can't really talk any more about the data again until presentation. But what I can say generally is we always see a correlation with usage with this therapy. So the two and change months is the median. That means some patients did less, or half the patients did less, half the patients did better. And what we see typically is the better the compliance, the better the outcome. So those will be data that we'll be analyzing and exploring. We'll be sharing with the clinical community so that they can maximize the benefit for their patients. OK. I know you want to be delicate about how much you say, but you still have patients from this trial that are wearing the device. That's correct. So it's not like, yeah, OK. That's fine. Yep. Got it, so shifting gears, some other recent news, almost like pales in comparison now just with how impactful PANOVA-3 was, but this was also important with getting the high-intensity arrays for GBM approved here in the U.S. So you've had these available in Germany for a while. Why is this so important? And why was this such an advancement to get this approved in the U.S.? Sure, and again, just to back up, when we started this year, we focused our organization on three core objectives: grow GBM, which had plateaued, launch lung, and deliver the pipeline. We've talked about one aspect of delivering the pipeline. The key benefit of the PMA approval that we received for the new arrays, and again, this is another PMA approval for the company, is that we can use these improved products to drive growth in the GBM business, so to remind everybody, to receive therapy, the patients need to, in the case of GBM, shave their heads and apply four patches to the skin, which attach to a Tumor Treating Fields generator. Our version one arrays work very well, but they have ceramic discs that are the insulators that prevent any electrical contact with the skin. They tend to be a little heavy. They're a little uncomfortable when you sleep with them on. They're not very flexible, and they absorb heat. So the heat dissipation of the array has some limits, and that actually limits the total amount of energy that we can deliver from the field generator. The new arrays are lighter, thinner. They don't have the ceramic discs. They dissipate the heat more effectively. Heat also can generate alarms. These new arrays generate many fewer alarms, and so what we've seen in Europe, where we received CE mark earlier and we've now rolled out in the important markets in Europe, is that the patients find these much more easy to use. And as a result, they can stay on therapy longer, and so I think as we roll these new arrays, so why is it important? I've talked a lot about them, but they create a real tailwind to the GBM business. And the GBM business is driven by, number one, prescriptions. And it's easier for a doctor now to see these and show them and have the patients imagine wearing these. It's also driven by the duration of therapy. And we haven't been long enough in Europe yet to statistically prove this, but certainly anecdotally, I think there's a good chance that we'll improve prescriptions and we'll improve the duration of therapy with these new arrays. And it also underlines something about our business model. And it relates back to IP. We continue to evolve the IP. And every time we create a new invention that's important, we're able to file new patents and extend the patent moat. So that's another differentiator between a device-based therapeutic and, say, a pure drug-based therapeutic. Yeah, and I think the opportunity to extend duration could be huge just because you're to multiply your effect on the entire wearer base. But again, probably a little ways out from fully proving that out. But the other point I'll make, too, is all the data that we just talked about in PANOVA, that was all old arrays. Right. So this technology will also now be incorporated in the lung and the pancreas applications as well. So it is yet to be in those applications. But my hope would be by the time we launch pancreas, it'll be with new array technology there, too. Got it. That's helpful. But to summarize, the real, if there's like a, call it a revenue opportunity here, a business opportunity, yeah, I know this is better for patients, but this is better for patients that removes the ability for them or the reason for them to say no, potentially. And also, theoretically, should keep them on therapy or drop out less than it might otherwise. That's a good summary? That's a good summary. OK. All right. Moving over to non-small cell lung cancer. I can't believe we're like 20 minutes in. It's now taken us this long to get to probably the indication where you're already launching and generating scripts. But a lot of good recent developments. You have U.S. approval that came earlier than expected. You have initial scripts that are written. You have some critics out there that are saying, OK, well, now that doesn't matter. They're still not going to, it won't get used. Doctors won't use it. And even if it does, it's not going to get paid for. I guess, how would you respond to maybe to the first point? We don't have to get down the payer route here. But how would you respond to the first point that's saying that doctors aren't going to use it? Yeah. So I would say the biggest disconnect between what I see on the ground and what we're getting credit for in the market is around lung cancer. To remind everybody, we performed a phase 3 trial in patients who had failed platinum therapy. So these are second- and third-line patients who received either docetaxel chemotherapy or physician's choice immunotherapy. The primary endpoint was to take all the treated patients, chemo or immunotherapy, compared to all the controls. We were statistically significant improvement in overall survival. Now, when you looked at the subgroups, the chemotherapy arm showed trend. But the real benefit was in the combination with immunotherapy. As I said before, these are metastatic patients. That's what we'd expect. The bear thesis, which is certainly the thesis that has dominated the markets last year, was that that's great. But because immunotherapy had moved from second line to first line, you don't have any patients because they're now all getting it in the first line. They're all going to get this old docetaxel in the second line. And you only had trend there. Said that. Then they said, and by the way, you're not going to get FDA approval. So number one, we got FDA approval. And we got FDA approval with the broad label, OK, which is what we said. Now we've done it. What has happened since we presented these data at ASCO, not last year, but the ASCO before, at that time, and these are round numbers, about 5% to 10% of patients were being retreated with immunotherapy in the second line. That number, having nothing to do with Novocure, has grown from 10% to between 40% and 50% now. So when patients go into the second line, they're off platinum. But that leaves just docetaxel. And for most of these patients, not quite most, 40% is not most. For many of these patients, the clinicians are leaving them on or switching the immunotherapy. This is tailor-made for us. These patients are already getting the immunotherapy in this line. And we come in on label on top of this immunotherapy. Plus, for the patients who, for whatever reason, are going to stay on docetaxel, we're still on label. And clinicians are telling us that for the younger ones who are really going to be compliant, we'll treat there, too. So we have to prove it like we have to prove everything. But this is the biggest opportunity. It's bigger than GBM. It's bigger than brain mets. And it's bigger than pancreatic cancer, this second line non-small cell lung cancer. And of course, here, too, we're running the phase 3 clinical trial to move it to the first line, which is, if anybody had lung cancer, that's where you'd want this. But we need to do the work to move it forward. But I see this as a big opportunity. We've just launched. Our focus in the early launch is not on driving numbers. And what do I mean by that? We want to make sure that these new prescribers, these thoracic oncologists, have a good experience. And that means they don't prescribe to the patients who are on death's door and who the family is saying, can we do anything? Can we do anything? They need to prescribe to the patients who have just recurred and who can take the therapy, who can comply, and for whom it will do a lot of good. They have a good experience and the doctor has a good experience. That's how we're going to build the foundation next year. Then we'll drive the numbers forward in 2026. Yeah. And that's where your technology is better anyways, is earlier on in diagnosis. But maybe going over to the reimbursement side, just to cover maybe a couple of last two topics here in the last minute and a half we have. I think you're saying in the last call, give us one to two years for coverage. I think that seems reasonable. Maybe for some historical context, take us through what happened back when you were going after coverage with GBM, the similarities and the differences that might exist because we're also several years removed from when that happened. Sure. So So this is a medical device. It's the DME channel. In the U.S., for commercial payers, we will treat all patients on label at risk. And we will expect to get paid for those patients in time. We go through, typically, the chief medical officer at the plans. We justify the use. And you go through a bit of a process and you get paid. For the larger population in lung cancer, which is the Medicare population, we need to build up. And we will also treat those patients at risk. We will build up a large enough group of those patients who are on therapy. And then we will go to Medicare to CMS to seek coverage. When we did this the first time with GBM, we were like, what is this? Tumor Treating Fields? Voodoo? We heard that word. I think the fact that we've gone down this pathway now with GBM, we're reimbursed in essentially every commercial plan and by Medicare. Now I'm confident in the commercial pathway, and I'm hopeful that the Medicare pathway will be straightforward for the second time. OK. Maybe potentially easier just because you've already been through it once and you've got a little bit of reference to go off of. That's the hope. All right. One quick one, just maybe probably more of a yes or no. We're a month away from a big conference in the West Coast. You have a history of pre-announcing results. Is that something you'd plan to do so again? Yeah. I mean, I think that makes it easier for everyone, and there's no reason for us not to do that. OK. All right. Excellent. Well, with that, we are out of time. Bill, thanks so much as always for joining us. Congrats as well on the PANOVA-3 data. And everyone in the room, thanks for your attention. And appreciate it. Yeah. Thank you. Again, it's been a great year for Novocure. Two PMA approvals, two successful phase 3s. I couldn't be more excited for the future of this company. Yeah. Agreed. Thank you.