NovoCure Limited (NVCR) Earnings Call Transcript & Summary

Good afternoon, everyone, and we appreciate you joining us for a fireside chat with NovoCure. I'm very happy to be joined by CEO, Ashley Cordova. Thanks for coming, Ashley. Hope the conference has been productive for you. I'm Kelly McCarthy. I'm from the Morgan Stanley Healthcare Banking team and really appreciate everyone who's joining us this afternoon. So I just want to kick off, maybe we can start high level, and you can give an overview of what you're focused on at NovoCure today.

Yes. Thank you. So thank you, Kelly, for having me and for the chance to start on. At NovoCure, we have one very clear and simple mission. Together with our patients, we're striving to extend survival in some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields. So we have one platform therapy, and we are heads down focused on bringing that to as many patients as possible. Now practically, what does that mean? At this particular phase in company building, we are transitioning from a single indication company with a very significant business in GBM, which generates $600 million in revenue and on its own merits, a significant amount of cash flow to a multi-indication platform. And as we look ahead, exiting 2026, we believe we will have 4 products in hand, a diversified revenue stream across those products and a clear path to profitability.

Okay. Great. And you are in a new seat at the company as of the beginning of the year. So in the CEO seat now, how do you think about the vision for the company? How you change that, maybe redefine that a little bit in your new seat?

Yes. So again, what hasn't changed is this mission and commitment to the platform. What we have focused a significant amount of energy on is just the basic organizational building and kind of strengthening of the capabilities to make sure that we have the teams in place, the ways of working in place to scale up and deliver the value of a multiple indication platform with the leverage in the P&L that we have today, right? So we believe we can do that. We have the field teams in place that we need to detail both indications that are in market today. And those same 2 teams will cover all 4 products as we exit next year. But we're really taking the time this year. It's a bit behind the scenes, but to make sure that we have the organizational strength and the kind of focus on scaling that we need to actually effectively accelerate top line growth and deliver it in a profitable manner. And the second point I will say is that a very clear commitment to profitability. We will make targeted investments, and we will make the trade-offs we need to make so that we do take this path to profitability.

Okay. I want to click into some of the indications that you've already gotten approval in and then some of the pipeline as well. But I guess, as you sit in your seat today, what rises to the top in terms of your priorities, both from a development perspective, commercial perspective, et cetera?

Great. So we have to start with GBM because that is the indication that we have in hand now 10 years post-launch and really is a fantastic business. As I said, $600 million in revenues. It's a mid-single-digit growth engine. That's what we've anchored people to, and that's what we see ahead as well. But it's also a very stable foundation upon which we can, with confidence, make the investments we need to in the future. Before I talk about that future, I want to also spend 1-minute talking about the value of just the experience that we have in the go-to-market model in GBM. We know how to not only develop this product, but actually bring it to patients. We have a DME that we have a device support specialist model that goes into the home of the patient to train them. We can do that at scale. We have a reimbursement engine and a revenue operations team that is able to actually get paid on this product at scale. And all of that process know-how we've learned in GBM will translate through to future indications. So that's the strength and kind of the solid foundation that we've built in GBM. And as we look ahead now, again, by the time we exit next year, we would expect to have 3 additional products in market. One, Optune Lua for non-small cell lung cancer, the second in pancreatic cancer and the third in brain metastases from non-small cell lung cancer. And I've joked that -- we used to get asked before we have the clinical data, which indication was our favorite, and we would laugh and say you can't have a favorite child. And now I will tell you that with these indications clinically derisked and with that in hand, I definitely have a favorite child. And my favorite child is pancreatic cancer. And I think lung is my problem child, right? It doesn't mean it's not a loved part of the family, but it is certainly our most challenging indication, and that's the one we're launching in market now. And brain mets, I think, is going to be -- it offer material upside and accelerate growth is probably the indication we're talking the least about with investors. But one of the ones we're talking the most about with our investigating community just given the interest and the fact that the radiation oncologist knows us so well. So again, high level, we're exiting next year with these 3 indications. All of them are clinically derisked. All of them offer a significant clinical benefit in an area of high unmet need, but they do have some puts and takes in how we're going to bring them to market.

Okay. Let's go deeper into some of these specific indications. You talk about GBM, is your beachhead in terms of your commercial franchise. You've captured very strong market share in GBM, as you mentioned. The growth has slowed a little bit in recent years. So what is your strategy for driving that next leg of growth?

Yes. The takeaway that we want everyone to have with GBM is that it is a stable and durable engine of mid-single-digit growth, right? So we're now at that phase of launch where it is just the basic blocking and tackling of continued sales force execution and overlaying some geographic expansion as we look to penetrating deeper in Europe. You just heard us announce in August the Spain reimbursement. And I think that's an example as France was a driver of growth for us over the last 2 years. We would expect as France is approaching maturity that Spain will layer on. And in aggregate, we're looking at a mid-single-digit growth engine, which generates a significant amount of cash flow, as I said, if we were to strip out the R&D activities. So it's not that there is a kind of hockey stick of growth coming up, but there's a lot of confidence that we have in how we think about measuring future investments knowing that we have this stable growth engine there. There is one trial which will read out in the front half of next year that could change that trajectory, and that is the TRIDENT trial. This looks at the potential to extend survival if we start Optune Gio with radiation 2 months earlier in the treatment journey than we started today. And if we are able to demonstrate a significant survival benefit there, we would expect to get 2 months of incremental duration on those patients, which is material as we build per month of therapy. And it also puts Optune Gio more squarely in the hands of the radiation oncologist who is our best customer set. So we're looking ahead with excitement to that data set. But I would say the takeaway from GBM is it's the steady eddie kind of engine of mid-single-digit growth that gives us strength to invest in other indications.

So mid-single digit on a global basis?

Correct.

Okay. And then you mentioned the trial is going to read out in the first half of '26, TRIDENT. Does -- can you talk a little bit about the benefit of moving earlier into newly diagnosed GBM patients? Does that expand the pie? Does that improve the actual benefit to the patient? I assume it does. How are you thinking about -- is it more clinical benefit? Or is it also commercial benefit in terms of size of the opportunity?

Yes. No, this is a clinical benefit. We're looking to see if we can extend survival for newly diagnosed patients. Our indication today is a newly diagnosed. So we're already first line and newly diagnosed. You can't go earlier in the kind of patient pool. But these patients today start their treatment journey post-surgery with radiation, right? They get 60 gray radiation. And the question we have is if we start concomitant with that radiation, can we extend survival even further versus what we see in the control arm, which will be ourselves started post radiation with the other standard therapies. So this truly does look to see, can we bring incremental clinical benefit by starting earlier. Now we have a strong scientific rationale to believe we can, else we wouldn't be running the trial, and this is because we know Tumor Treating Fields inhibits DNA damage repair. And so while radiation is quite effective, we are also quite good at repairing the DNA damage overnight in between those radiation sessions. And that is really the question we're asking is, can we make the impact of radiation better such that we further extend survival. If we don't show a significant benefit here, the label will stay as it is today, and people would start post-radiation as they do today.

Okay. Got it. And is there another Phase III trial here?

We are enrolling in a trial called KEYNOTE D58, which looks at the potential to significantly extend survival when you add KEYTRUDA or pembrolizumab to the regimen. I will remind everybody that the pembro trial in newly diagnosed GBM did not succeed when it did not have Tumor Treating Fields in that backbone standard. But we know from our preclinical experience to date, and we've seen in several clinical settings that Tumor Treating Fields induces an immune response. We see immunogenic cell death. And because we know we can do that in the brain, we are hopeful that the combination will open up glioblastoma to the effects of IO. We have a Phase II trial that Dr. Tran ran that supports this trial design, and we're very excited for that trial to be open and enrolling.

Okay. Anything else you want to say about the GBM opportunity before we move to NSCLC?

No. I mean I will just remind everybody that this is our beachhead, and it is a fantastic business. As I said, $600 million in revenue that generates a significant amount of free cash flow on its own feet and one that we're very pleased with and provides us confidence as we look ahead.

Okay. So going to lung cancer. You launched in second-line non-small cell lung cancer last year. Can you talk about the early quarters of launch? What has the big challenges been?

Yes. So as I noted upfront, of the 3 launch indications, we always knew lung would be the hardest, and it is, in fact, the hardest is how I would summarize it. We are able to get in front of this position with a message of clinically meaningful data in a patient population with high unmet need. The data discussions are going very well, but this is simply a very crowded and competitive space with the rapidly evolving landscape and the ability to capture mind share and relevance in such a competitive space is hard, right? This is also the first time we are detailing medical oncology community with our device-based message. And we are a device in a drug-based world. And I think that we knew that education would take time, but it's, I would say, taking twice as long as we thought it would. So what does that mean? It means that the launch -- the facts on the ground are that the launch is behind expectations, and we have not seen meaningful growth. But we do know that the investments we're making in this education will bear fruit across the portfolio. And this is the question we ask ourselves all of the time is -- as I look at the portfolio of opportunities and the education around Tumor Treating Fields in a medical oncology setting, particularly as I look ahead to pancreatic cancer, this call point is valuable and this time spent in office detailing is valuable, but the lung launch itself has been behind expectations.

Okay. So the launch has started in the U.S. and Germany. How are you thinking about further geographic expansion, particularly in bigger markets like Japan or France?

So Japan will be next, and we do believe there will be a material opportunity in Japan. Japan under-indexes in GBM, just in East Asian populations, the incidence is lower in GBM, but over-indexes in non-small cell lung cancer. We believe we will have approval by end of this year and reimbursement to follow a couple of quarters later. That is a national payer. So when you get reimbursement in Japan, it is a switch that turns on. And as we're able to drive demand, we are getting paid for that demand. So as I look ahead, we are focused on Japan. France will come with reimbursement. We will not launch at risk in any additional markets.

Just on that topic, can you give an update on the reimbursement dynamics in the U.S. and Germany where you've already launched?

So the reimbursement will largely be gated to Medicare for lung in the U.S. because Medicare is 75% of the payer population. We have submitted for an LCD reconsideration, but that process takes, we estimate approximately 2 years. In the commercial setting, things are ahead of expectations, actually. What we are seeing is that while demand is behind, actually, the payer dialogue is going very well. And it speaks to, I think, the relevance of the data that when you're sitting in front of somebody and having a conversation about the unmet need in the data, this is a very easy conversation. And so we are confident that we will get there. We are seeing very good progress in the commercial setting, and we're standing by that estimate of approximately 1 year to reimbursement in commercial and 2 years in Medicare. And I would say that applies to future indications as well.

Okay. Very helpful. I want to talk a little bit about LUNAR-4, which is a Phase II trial that was being run in lung cancer that was suspended. What should investors take away from that update?

Yes. Thanks for the question because I think this actually specifically points out our commitment to a path to profitability and our willingness to kind of rechallenge assumptions that we had in the past. We know that there is a very relevant scientific question on what is the overall survival signal when you are looking at an ICI retreatment or rechallenge in a previously ICI-treated patient. This is where the market is, and we know this is a very relevant question. That's why we started the LUNAR -4 trial. We also know that in the U.S., 90% plus of our patients that are starting Optune Lua have had prior IO. So we have an ICI retreatment population in our commercial patient population today in the U.S. And this was always a signal-seeking trial. It was Phase II. So it was not powered to be registrational. And so the ability to look at real-world evidence in the U.S. and answer that question is a much more cost-effective and transparently quicker answer to that question. So we're pivoting not away from that question, but we're pivoting to the source of that data, and we will answer that question and real-world evidence in the U.S. And I think, again, this is just an example that's making the trade-off so that we can keep that cash on the balance sheet and our path to profitability.

Got it. Okay. Let's talk about some of the new indications and particularly your favorite child in pancreatic. You just filed the PMA in pancreatic cancer in August, and you plan to file in brain mets later this year. So how do we think about approval timing? How do we think about the path forward to commercialization there?

Yes. So the PMA submission for pancreatic cancer went in on August 15. It is a 180-day clock, but that clock stops any time the FDA asks questions, and there will always be some questions back and forth. So our guidance is to assume 9 to 12 months to approval from submission, which would put us at summer of next year. We are prepared -- preparing to launch, I would say. As I noted, it's the same field team that covers Optune Lua today that will be detailing the pancreatic indication in the U.S. So effectively, they're already in their training sessions, but they're out there in their day jobs detailing Tumor Treating Fields in a different indication. So we'll be ready. MET is a modular submission. Modules 1 and 2 are with the FDA. We've had our presubmission meeting on Module 3, and we're around the corner from that submission as well. So that would put that launch in the back half of next year. Again, we're doing all the work that we need to prepare campaigns. But similar to Optune Lua, there is an overlap in the field force that covers Optune Gio that will detail the metastatic indication.

Okay. So -- the overlap on the salesforce seems very helpful, but...

It's -- this is how we get the leverage. We have the teams we need in all of our major geographies.

I guess what would you say for that -- those teams, those 2 teams, respectively, what the learnings have been? Or maybe even what could have -- what they could do differently than what was done in lung cancer?

Yes. I love that question because there have definitely been some learnings, right? And I'll start with the statement that we are a device in a drug-based world. We know that, but we're just constantly reminded of that, right. So what it means is that you need to go in with a little bit of a device-based marketing spend. And I think in oncology, we're used to leading with the overall survival benefit, right? That's what sells, right? The data cells. We're realizing and we're learning in lung, and we'll capture this learning as we look ahead that we probably need to start with an explanation of what is the device. And actually, in our early engagements, things as simple as like having the device in the room, so that the prescriber can actually tactically see it and touch it and explore it, that matters, right, which is a very simple shift, but it's not intuitive if you're thinking about the power of your overall survival data out the gate. So we'll take the time to do the device education. And that's certainly a lesson learned, and I think we're learning the best way to do that. I think we're also learning of the power of that peer-to-peer kind of hyperlocal device-based education where in a traditional -- I'll just use an example, speaker bureau, a physician might want to hear from a national KOL explain and contextualize the data. That's always helpful. But in this setting, we're realizing that, that prescriber might benefit more from a conversation with the radiation oncologists down the hall from them that treats GBM that can talk about how they've integrated Tumor Treating Fields and Optune into their practice. So making those hyper-local connections to make sure that we have peer-to-peer dialogue around the device, that's a lesson we've learned and will carry forward to future indications. I also think there's just a platform effect that comes with -- when you have multiple indications that are on market, there is a little bit of a halo. We often say it's either the same physician being detailed both indications in the community setting or they share the same water cooler. And they probably share the same waiting room, and they're going to see patients wearing the device across indication. And all of that helps just make it feel like a platform and not so unique to one indication. And transparently from a durability of growth, the diversification of having 4 products in market, launching and growing at once also provides us the stability to not be so dependent on any one indication in any one quarter. We're going to be looking at how do we accelerate top line growth across the platform.

Absolutely. Yes. And I don't want to miss the PANOVA-4 readout that's coming in Q1, I believe. That's going to be a Phase II readout in pancreatic. Can you talk a little bit about what -- how that could be meaningful?

Yes. It is an exciting data set for us, and it will be out early next year. This is taking the combination of Gem Abraxane and Tumor Treating Fields into the metastatic pancreatic cancer setting and then also adding atezolizumab in IO. So you're looking at 2 interesting questions. First of all, what is the effect in the overall survival signal as the disease control rate signal when we add Tumor Treating Fields in the metastatic setting. Our current label will be locally advanced. And then it also looks at the incremental benefit from IO. And similar to the conversations we are having in GBM, pancreas is a tumor, a region of the body that has been privileged from the benefit of IO in the past. It's a cold tumor microenvironment. It has the protection of the stromal tissue and many of the systemic agents that would be used to activate the immune system do not penetrate the region. We believe that Tumor Treating Fields will be able to do this. So this is, again, a Phase II trial, but will be very interesting as a signal-seeking trial and the data will be very informative from where we go next, both in metastatic setting and an ability to combine with IO in pancreatic cancer. And I think this is very exciting to the prescriber community. If you -- for all of the advances that we've made over the last 2 decades, there have not been significant advances in pancreatic cancer, and they're ready and eager to kind of open up that tumor type to IO.

Okay. We'll be watching for that update. Ashley, I'm going to ask you to put your old CFO hat back on briefly. And I know you made a few comments about profitability and your goals in reaching profitability at the beginning. But I would like to just understand your current capital position. Does that enable you to reach that point? How you think about keeping the company well-funded? And what does profitability mean for NovoCure?

So we are very committed to this path to profitability. And yes, we believe we can do it with the balance sheet that we have on hand. And I will say very strongly that we are committed to this path. What does that practically mean? Again, the easiest way to get there is through accelerated top line growth, and we can see that around the corner as we look at having 3 launch indications next year and a 4 product portfolio as we exit next year. There's a significant amount of leverage, as I noted, pulling that through. The sales and marketing infrastructure that we need to support all 4 indications is already in our P&L. So there will be some incremental spend as we support launch campaigns and the paid media associated with that. But we're really talking about small incremental spend. The vast majority of the SG&A infrastructure we need is in place today. If we need to, we can also control the lever of how much we put in R&D, right? So we are an oncology company looking to invest in our future. So we're not looking to slow down our investments in R&D. That's where the future growth comes from. But if the top line growth does not paint that clear path, we will make the adjustments that we need to make in order to get there. And I actually think LUNAR-4 is a perfect example of that what -- at a small scale of the types of decisions we're willing to make. So that's how I can say with confidence, I see a path to -- we think of adjusted EBITDA as being that target that we would look to turn positive. And when we think about capital structure, I mean, we have the balance sheet. We need to do this, right? Cash runway is not an issue as we look at being in control of the levers to control that path to profitability. And we're sitting on more than $900 million in cash today on the balance sheet. We do have a convert, which comes due by the end of this year. We expect that we will pay down that convert with the cash we have on hand. We have an existing credit facility in place. We've pulled $100 million of that. We are obligated to take on the second $100 million that will come on this quarter. So you will see us exiting the year, we believe, with more than $400 million on the balance sheet and the convert paid off, and that is sufficient to get us to where we need to go, we believe. And I could say, at a very personal level, I'm committed to that. This is something I know brings value, and this is probably the instance where my ex CFO hat, it should give some investors some reassurance there.

Okay. Great. I just want to talk about where your stock is. Obviously, it's been a volatile year in biotech in general, and you're not alone in facing some bumps in the road. But what do you think investors should be focused on, or isn't resonating and that they should be focusing their attention on about the story?

Yes. I think the messages are similar to what I've hit on before, but I think that is -- there are some simple messages. There's a couple of core facts that I just think are not appreciated in the current valuation. The first is we have an existing commercial business today in GBM that on its own 2 feet generates a significant amount of free cash flow. It is a mid-single-digit grower. It's not a double-digit grower, but it is a very kind of reliable engine of growth. That's the fact that we have in hand today. And again, we're at the cusp of having a portfolio of opportunities to accelerate that top line growth as we look ahead with a clear path to profitability. And I just -- I do think there's a disconnect between those 3 facts and the valuation that we have in hand. I will say, I think it's a confidence issue, not a fundamental issue. And so then it's our job to execute, right? And we understand that. And as I look back through this year, I'm quite proud of the execution of the team. We've advanced the regulatory filings for pancreatic and METIS. We have gotten approval in Spain. We've delivered on the growth targets that we set ourselves in GBM. We have been on podium and concurrent publication at ASCO, and we're getting ready to be on podium at ASCO with the METIS data. So the team is working very hard. They are focused. And I do think with time, that will bring value back to the story.

And I just want to go back to the point about the platform and Tumor Treating Fields because it is a very unique modality in biotech. So I just want to hear from you what gives you guys the confidence that, that is the right modality and the right technology to be investing in across these different areas? And what gives you confidence to keep pushing that story to investors who may not be giving you value for all these different indications?

I mean we know because we see the data, right? And we think that's -- and it's not just the clinical data we have in hand, but all of the preclinical data and the translational work. And I will also think that we used to have a message of broad applicability on top of whatever standard of care. And it is still true that actually our primary limitation is physical. There's not a certain biomarker or a certain tumor type that is not predisposed to Tumor Treating Fields. But actually in a world of hypertargeted treatments, what we're realizing is that there's a very special role for a modality like Tumor Treating Fields to play, where you need the ability in some of these challenging microenvironments to have a different tool that is not just like the other systemic agents that you have that might help whether it's activate the immune system or deliver an antimitotic effect or help inhibit the DNA damage repair, where for some reason, all of the advances that we've had to date are not reaching that tumor. And we offer a totally different pathway, a physical pathway to get to that tumor and to, as I said, activate the immune system, which I think is the future, not only of the IOs that we have in hand today, but as we look ahead to the next generation of immune therapies, where a lot of the excitement will be. So I think we're well positioned because we are so uniquely positioned to bring something different that can be used in combination to help further extend the benefits that we see of the evolution and without competing toxicities. We don't have the systemic toxicities that you see in so many of the other combination products. And that brings real value when we think about needing to have a kind of a well-rounded armamentarium of tools to fight cancer.

Okay. Well, congratulations on all the progress across the pipeline. We'll definitely keep track of some of these upcoming readouts and regulatory updates. Before we close, anything you'd like to leave the audience with as a final thought or anything you're personally excited about in the company's future?

First of all, thank you. I know this is the end of a long conference. So thank you guys for being here still and for your ongoing interest in the story. The messages are clear. So I'll just reiterate them that we are really at a unique position in this company as we transition from a single indication to a multi-indication platform. That's not a dream or a potential anymore. These are kind of the execution points that we have in hand and the catalysts that we have in the near term as we look ahead 4 to 6 quarters. We can see accelerating top line growth with the 3 launches built on top of a solid business that we have established today with a go-to-market model that we know well, and we have a path to profitability. So I'm excited to help deliver this promise, and I hope you can hear that in my voice, and I look forward to updating everybody in conferences to come.

Great. Thank you for joining us. Hopefully, it's been a great conference for you to participate in, and we're looking forward to continuing to track. We -- when I met you, you were a single approval, single asset company. So it's been great to see you execute across the pipeline, and we're rooting for your success. So thank you for joining us.

Thank you, Kelly.