NovoCure Limited (NVCR) Earnings Call Transcript & Summary

Great. Good morning, everyone. My name is Jess Fye. I'm a biotech analyst at JPMorgan and we're continuing the 43rd Annual Healthcare Conference with NovoCure. First, we're going to hear a presentation from the company, and then we're going to go into some Q&A. And if you're in the room and you want to ask a question, just raise your hand, someone will bring you a microphone or you can send them to me via the portal, and I'll ask them up here. So with that, let me turn it over to the company's Executive Chair, Bill Doyle.

So good morning, everyone. Thank you, Jess, for inviting us again this year, day 3 of JPMorgan, it's good to see such a full room. So it's my pleasure to start the presentation today. Of course, we will be making forward-looking statements, and you can see the full disclosure on our website. And remind everyone that we are a company that was founded to extend survival in some of the most difficult to treat cancers. And I'm pleased to report this year that we've made tremendous progress with respect to our mission. I want to start, though, however, and remind everyone that we are bringing a completely new mechanism of action to bear against these difficult-to-treat cancers. We were founded by Professor Yoram Palti of the Technion in Haifa, who first made the hypothesis and then proved it that intermediate frequency electric fields could interfere with the machinery of cell division and kill cancer cells. And again, you'll recall that electric fields at low frequencies will stimulate nerves and muscles and have been used for decades in things like pacemakers and electric fields at high frequencies, likewise, long known to generate heat and have been used for decades for various ablative therapies, but this intermediate frequency was thought to have no effect. And what Palti proved was: number one, we could tune these frequencies to target the cells of interest, which of course, in cancer is important; and then secondly, that once these cell -- once these electric fields penetrated the cells of interest, they did tremendous damage. Our initial knowledge showed that we could interfere with the formation of the tubulin spindles and create cancer cell death. In the 20-plus years since, we have learned that these electric fields, in fact, do much more. For instance, they open the blood-brain barrier. They cause increased concentration of chemotherapy in cells. And maybe most importantly, for some of the data that we'll review is that the cell death that is affected is immunogenic cell death. So when we kill these cells with electric fields, we expose the antigens in the cells to the immune system. So one of the interesting, maybe most interesting, things about our company is that while all the data you see, you could look at these data, just like any other drug therapy development company. We run Phase III trials like any biotech, but we deliver our therapy with a portable, wearable medical device. So we're not a drug, we're a device. And in this picture, you can see the current generation of the device has 2 parts. There's a boxed field generator that the patient will carry and wear. And then what you're seeing here is our very next generation of array that is attached to the skin in the region of the tumor and that delivers the therapy. And what we see over and over again is a very pronounced dose response. So when patients use this continuously, they see the maximum benefit from the therapy. So turning to the business. Since Palti founded the company over 20 years ago, we've built a very strong commercial foundation treating glioblastoma. And for those of you who have been touched in one way or another by glioblastoma, you know this is, in fact, one of the most difficult cancer diagnoses. But we've made tremendous progress against this disease. We're approved now and reimbursed in essentially every important major market. In the U.S., we're NCCN Category 1, which of course, is the top category for establishing standard of care. At this minute, we have over 4,000 GBM patients on therapy. And again, important for our -- the establishment of our commercial foundation, we reported just on Monday, $600 million in revenue. And we believe that, that base is what is going to enable us to -- and has, in fact, over the last number of years, enabled us to continue to invest in our pipeline to expand this further. So when I was here last year, beginning of 2024, I reported to all of you that 2024 was a show-me year for NovoCure. And we, in fact, had focused our activities. And this is, of course, one of the big challenges of a company like NovoCure with a platform where we can take this in so many directions, so many difficult-to-treat cancers. But we said, no, we needed to focus and really show our employees, our constituents in the medical community and, of course, our investors that we were going to accomplish 3 very important things: the first was to grow our GBM business. For the last several years, our GBM business had plateaued at $500 million, even though we knew that it had more potential. And we also know, as I just said, that the more revenue that we derived from the GBM business, the more investment we could make in the other areas. And we're very pleased to report that we grew that number from $500 million to $600 million. This was on the back of a very successful launch in France, which is now approaching a market of, we call it German size, because we've been in Germany much longer and improved U.S. approval and collection rates, which is really a result of making sure that we're getting on-label patients on the therapy and through the approval process. So that was objective number one. Objective number 2 was the launch lung. And this is where I will acknowledge, I think, the biggest gap between the investor community and what we believe to be reality. We went into the year with a lot of skepticism that we were going to even get FDA approval. Further, there was skepticism that we were going to get a good broad label based on our Phase III data. Again, I'm happy to say that we were able to achieve our objectives here. We received PMA approval with the label that we were intending to receive, which is a broad label. And the day after we received the PMA, we launched in the U.S. Our focus this year is educating doctors to get the right patients on label as early in their patient journey as the label will provide for and we're extremely happy with the progress that's been made since the launch in Q4. So another check box. And then finally, deliver the pipeline. And what we met here specifically, and as I said before, notwithstanding all the possibilities here is our real focus on METIS and you'll recall, METIS was our Phase III trial in non-small cell lung cancer that had metastasized to the brain. Again, 25% of all patients with non-small cell lung cancer diagnosis have brain mets. Another 25% will be diagnosed with brain mets during their patient journey. Today, the standard of care is watchful waiting. It's often the point where patients will go to hospice when they have brain mets. We have fantastic Phase III data now that prolongs progression in neurocognitive decline for a year in Phase III data. And importantly, the first successful Phase III trial in locally advanced unresectable pancreatic cancer ever. And I'll also add the PMA for the flex arrays, which are important for patient care, comfort. And so this has been -- we set out to have a show me here, and I think we've accomplished it. Now the one other thing that we didn't talk about last year, but we also set to accomplish is preparing the company for this important next phase where we go from a single indication company into a multi-indication company. And critical in that was a repositioning of our management team. And as I said, this, you don't announce ahead of time, but we had a very careful 2-year succession planning process to turn the company over from a team that I'm very pleased to have been part of for over 20 years to a new team that we've been growing within the company. And we were very pleased to announce that Ashley Cordova, on my left, as of January 1 has taken over from Asaf Danziger as our new CEO. I have to give a shout-out to Asaf. Without Asaf, there'd be no NovoCure. But it is with incredible enthusiasm that I welcome Ashley. So Ashley started her career in health care 20 years ago. She started at Pfizer in the finance department. She rose -- was identified as a superstar early on, rose through the company, including running the $2.1 billion primary care West business for Pfizer. She was tapped as part of the Zoetis spinout team and created the treasury function for Zoetis. And as we were building our IPO team, that's when we were able to entice Ashley out of Pfizer with the promise of entrepreneurship and fast growth and actually joined us 10 years ago, has continued to show all those superstar qualities, rose within our organization. Five years ago, we named Ashley CFO. And I would say, Ashley, there are sort of narrow scoped CFO and broad scoped CFO, Ashley has run all -- of course, the finance functions as well as strategic planning and has been a real, I don't want to overuse the word, pillar, but Ashley is a pillar in the company. And with that, I'm going to sit down and hand the clicker to Ashley to talk about the future of NovoCure.

Thank you, Bill. Thank you guys all for being here today. NovoCure really is at an incredible inflection point, and I could not be more excited to be a part of this journey and to take over CEO at this pivotal time. As Bill mentioned, I did join 10 years ago, and I was a part of kind of the corporate narrative from IPO through here, and I was reflecting that we've had a consistent value proposition but real evolution of that over the last 10 years. When we were on the road for the IPO, we were selling the promise and potential of the GBM commercial business with the promise and the potential of our pipeline. Then if we zoom forward 5 years later into the launch in 2020, we were selling really the incredible strength that comes from a strong commercial business in GBM that helps fuel the potential of the pipeline. And it's really fun to be here today, now, 5 years later and get to talk to you, investors, about the incredible strength that continues to come from the GBM business and the very real near-term opportunity we have to launch now in 3 additional indications, which have been clinically derisked. And yet, in fact, we still have the promise of that future pipeline. So we're not done developing, but we are now moving into an execution mode with a lot of real material opportunities in hand. And our vision hasn't changed The mission we're here, striving to extend survival in some of the most aggressive forms cancer that's been core to our being since the beginning and we'll remain core as we look ahead. And I've actually spent a lot of time as I come in onboarding, reflecting on what that means. What does aggressive cancer mean. And it's interesting, I think I was actually poking around in this year database for all of the incredible progress we've made over the last several decades in oncology, thanks to the work of many of you guys in this room, there are still 8 solid tumors for which the 5-year survival rate is less than 50%, meaning you are more likely than not to not be alive 5 years after diagnosis. And I'm proud to say that NovoCure has positive trial data in 6 of those 8 and we're only beginning. So the problem statement is very clear. We know there's a need out here for all the progress that's been made. We need new modalities to treat solid tumors. And I want to run through now a catalog of clinical data that shows how Optune and Tumor Treating Fields in NovoCure can make a difference there. And it does feel like a catalog, and that's kind of the point because what we have here is an extremely consistent platform-based therapy that's been proven to extend time after time, overall survival in multiple solid tumor types. So I'm going to start with newly diagnosed GBM. We built our commercial business on GBM. And what you're looking at right now is the EF-14 clinical trial data. This was the data that backed our successful launch in 2015. And what you'll see in all of these Kaplan-Meier curves is the colored data point is the benefit that you get when you add tumor treating deals on top of the standard of care. So the standard of care prior to Optune Gio, which is what we call the commercial product in newly diagnosed GBM was a chemotherapy called temozolomide. And when we add Tumor Treating Fields to temozolomide, what we see is a 6-month extension in overall survival, significant improvement at the landmark 2-year survival rates and a more than doubling of 5-year survival rates. And importantly, we're able to do that without any additional systemic toxicity across all of our solid tumors. The only side effect we tend to see is skin irritation at the site of the ERA. So on the back of this incredible data, we have now built over the last 10 years, a very successful commercial business, as Bill noted, with more than 4,000 active patients on therapy, established reimbursement in the U.S., Germany, France, Japan as well as 6 other global markets, and we're delivering $600 million in annual net revenue. So that's the foundation, and it's a very strong one. But now let's talk about the future and where we're heading. So the next indication we can talk about with another beautiful Kaplan-Meier curve on the left is metastatic non-small cell lung cancer post platinum progression. And again, this looked at a trial where you're taking what is the benefit that we can derive from adding Tumor Treating Fields on top of the standard of care, which for metastatic non-small cell lung cancer patients, post-platinum is either an ICI or docetaxel, and this was physician's choice. And we looked at could we extend survival when Tumor Treating Fields was added on to the standard of care. And the results are clear, we saw a 3-month extension in median overall survival and again, with no added toxicity. Importantly, this is the first Phase III trial in more than 8 years to show a significant extension in survival in this patient population and forms the backbone of our recent PMA approval in the U.S. on October 15, as Bill mentioned, with that broad label. The team was trained and ready to go, and I'm thrilled to announce that on Monday, we announced that we had 52 active -- we had 52 prescriptions in those first 10 weeks. And at the end of the year, had 20 patients already on Optune Lua therapy in the U.S. We're in the process for filing globally, and we look forward to providing updates throughout the year on this successful launch. Before we move on to our next indication, though, I want to spend a moment on perhaps one of the most interesting data analysis that came out of the LUNAR data set, which is the combination of a powered subgroup when you look just at the benefit of adding Tumor Treating Fields to the ICI versus ICI alone. And what you see here is an incredible and unprecedented 8 months improvement in overall survival from 10.8 months to 18.5 months and an impressive hazard ratio of 0.63. This is incredibly meaningful data. It's important for patients with metastatic non-small cell lung cancer, but it also points to the potential to substantially bend the survival curve when Tumor Treating Fields is used in combination with immunotherapies across multiple solid tumors. We are continuing to explore this mechanism of action where you get not only the antimitotic benefit of Tumor Treating Fields, but the benefit of the immunogenic cell death, as Bill mentioned earlier. We're studying this actively in non-small cell lung cancer today with the LUNAR-2 trial, which moves this protocol first line, but we're also exploring it in GBM with our KEYNOTE D58 trial and in pancreatic cancer with our PANOVA-4 trial. So really exciting science coming out of this field and really impressive survival data that we are excited to continue to explore. Okay. We go on to another, third very pretty Kaplan-Meier curve that we get to look at here, which is our data in brain metastases from non-small cell lung cancer. This was a trial that looked at the benefit of applying Tumor Treating Fields to the head after stereotactic radiosurgery for patients with brain metastases from non-small cell lung cancer while they were still receiving active treatment for their primary tumor versus watchful waiting, which is the standard of care today for patients with brain mets. And again, what we see is a very clear and sustained benefit in the time to intracranial progression for those patients that receive Tumor Treating Fields. This data was presented at ASCO in June with an impressive overall survival benefit where we took the time to intracranial progression from 11.3 months to 21.9 months and importantly, we maintained quality of life and neurocognitive function, which are 2 key treatment challenges for physicians looking to treat brain metastases. This opens up a window of treatment opportunity for the primary tumor, and that has been one of the primary challenges in this space. So we're really excited about this indication. This is the same customer set that treats GBM. So this is a rad oncs that already knows Optune Gio and is excited to get this on the market and we're in the process of preparing those regulatory filings now. We announced in October that we received breakthrough device designation, and we're in the process pre-sub discussions with the FDA and again, look forward to updating everyone as we go through the process this year. Okay. Final data set. It's not quite yet a pretty Kaplan-Meier curve because we've only announced the top line data, but we do expect to announce the full data set at an upcoming medical conference soon. What you do see though is in pancreatic cancer, which is an incredibly challenging tumor to treat. As we all know, we did demonstrate and just announced in December a significant extension of 2 months in overall survival for patients with locally advanced unresectable pancreatic cancer. This is the first and only trial to ever demonstrate a significant extension in survival for this patient population. And I can tell you just the feedback from the patient advocacy groups from the physicians. And honestly, internally, the company is that this is extremely clinically meaningful. The energy is there. People are excited. They're ready to see the full data set. And we're ready to get this package with the FDA. We did announce on Monday that we have also received breakthrough device designation for this indication, and those filings will be with the regulators this year. Okay. So that's a lot of data. And I think that is in one summary, the point of like what we're looking ahead to for the next 2 years. Here, we have an established commercial business in GBM, but we have an incredible opportunity to execute on clinically derisked data in the near term. And what does that all mean? It means we have an opportunity here to -- on the solid foundation of GBM to have a 7x TAM expansion, again, with launches that will happen between now or in the end of 2026, so a very near-term opportunity to 7x our business on the back of the learnings and the success that we've had in newly diagnosed GBM. The binary clinical outcomes, I would say, are now derisked, and now it's just execution, right? So there's -- I'm joyful to take on that pressure, and I want to spend one minute talking about what execution means as we look ahead, right? So we have a long list of commercial milestones that you should expect to see come out of NovoCure over the course of 2025. I do think it's important to run through these quickly now because this is what we'll be here talking to about throughout the year. In LUNAR, we'll continue to provide updates on the success of that launch. As I mentioned, again, 52 scripts already in the first 10 weeks of launch, but you'll see continued progress in the U.S. launch there. You also see us report progress towards reimbursement with material revenue coming online in 2026 and you should also expect to hear regulatory updates as that package proceeds with the TUV in Europe and with the PMDA in Japan. As we look to METIS, we would expect to have that full data set published in 2025. And again, that package with the regulators this year, which would enable a launch in 2026. And for PANOVA, you should expect to see that data presented at an upcoming medical conference published in a peer-reviewed journal and again, submitted to the FDA, both METIS and PANOVA under the breakthrough device designation with launches to come in 2026. But we're not just a commercial company. We have the strength of this commercial business, the near-term commercial opportunity, but we also have the clinical pipeline. And highlighted in blue here on this slide are milestones over the next 2 years that you should expect to come out of our clinical pipeline. I've already talked about PANOVA and METIS, which will have regulatory milestones as we move those through to approval. But I would also highlight 2 additional primary data sets that will come out in 2026: the first is a large randomized trial called TRIDENT, a newly diagnosed GBM, which looks at adding Tumor Treating Fields to radiation therapy two months earlier in the treatment journey, potentially expanding the duration and the efficacy of benefit for those patients with GBM. And also our PANOVA-4 trial, which looks at the combination of atezolizumab with Gem/ABRAXANE protocol in metastatic pancreatic cancer. Both of those data sets will be out in 2026. And then if we take a little bit of a longer-term view, we also have 2 ongoing registrational trials underway that won't have data in the near term but will be key to our TAM expansion beyond that original 7x. The first is the LUNAR-2 trial, which looks at first-line use in non-small cell lung cancer in combination with Pembro. And the second is the KEYNOTE D58, which looks at that same combination in newly diagnosed GBM. So we're really excited about the clinical opportunity here both over the next 2 years, but also for the long term. And what I will say is not on the slide because it's a little bit harder to put on a clean video -- on a crisp video is all the work that we're doing on the product development side. One of the benefits of being a device company in oncology is that you get to innovate not only in the clinic, but you also get to advance and innovate on the product. We took significant steps forward there this year with our new array, which we took and launched globally for the head in 2024. We're looking at taking those advancements and bringing them to the torso next year. And then as we look at beyond, we're looking at the generator, at the form factor of the battery and all that we can do to build a connected ecosystem for the product. So we have opportunities to innovate in both of those spaces. And again, you've heard this message before, but I'll reiterate it because it's a consistent and unique value driver that we get to do all of this development and innovation on the back of an extremely strong commercial business in GBM. You see 4 of our kind of key value drivers highlighted here, which we touched on before, but I will highlight again the strength of $600 million in net revenues from GBM. That is a business that is maturing, and we would expect to continue to grow in kind of a low mid-single-digit rate next year, but it provides us incredible flexibility to invest in the future. And in fact, in and of itself generates about $100 million of free cash flow, which we're able to put back into the pipeline, and you see us continuing to do that with $200 million to $250 million invested in R&D, both clinical and product year on the strength of that existing business. I will also say it provides us the know-how to pull through these launches that we're looking to deliver in '25 and '26. We know how to get this to patients. We know how to train the patients and their caregivers. We know how to get built and reimbursed for it. Okay. So in summary, the vision here is clear. We're striving to extend survival for as many patients with aggressive cancers as we can. We're doing this on an incredibly solid foundation with more than 4,000 active patients today, and we have a near-term opportunity in 2025 to continue to increase GBM penetration to focus on a successful launch lung to launch the new arrays, but a 7x TAM expansion opportunity on the horizon with METIS and PANOVA and further product development and then we're not done. So if we look out beyond the next 2 years and the work that our teams are doing, we are only beginning, and I'm really looking forward to joining you guys next year and throughout the year to share updates and our progress along the way. Thank you.

Great. So thank you for the presentation. Maybe just start at this kind of time of leadership transition, not that you're particularly new, but as you take the home as CEO, Ashley, what are your goals for NovoCure coming up this year? What should we think of as potentially changing? What's likely to stay the same?

Yes. I mean I think a lot about that. And I would say it's more of an evolution than a revolution, right? And that's because we have such a clear vision. We know what we're doing. And I would say, regardless of leadership changes, we know that this is the time when we get to transition from a single indication company to a multiple indication company. Now I just get to be kind of the steward of that inflection point, I would say. We feel like we have the right team in place. I am new enrolled, but I feel very much not new to company. And I think the teams feel that as well. And I would say for many of our other executive team members, they are also multiple years enrolled very intentionally brought on. I'm thrilled to see Christoph sitting in front of us here, joined as CFO. We have a new CMO in place. We have a new CHRO in place. We have the team that we need to really execute a consistent vision, but just focus on doing it across multiple indications. Very few companies get the opportunity to transition from a single commercial business to multiple indications, and we continually remind our teams of kind of the precious state that we're in there and that the need that we have to kind of stay focused and execute.

Okay. And can you talk more about the new arrays? How are they rolling out? And how should we think about them impacting gross margin?

So they are rolling out. That's the first step. So we have been approved now in all of our major markets, and they're on every new patient that would start in our major markets get started on the new array. It provides a much more comfortable user experience, it's lighter. It's more flexible. It generates less alarms. Long term, we hope to see that impact in extended use in duration. It's still a bit too early to see that in the actual numbers, but that is the hope and the promise. But -- so that's the good news. And that's why we do these product innovations, the bad news in the short term is that we have the cost to optimize that product. So as we have a very optimized manufacturing line on our old array and both as we launch the new array and as we launched the torso applications which are lower volumes and larger rates in cells, we would expect some margin pressure. I would expect it to go towards the lower 70s in '25 versus the higher 70s where it's been. That is very temporal and with scale and with volume that will revert back to the kind of high 70s.

Great. Maybe starting with GBM, can you just give us kind of the latest update on commercial dynamics you're seeing in your various regions, whether it's the U.S., Europe or beyond?

Yes. I mean GBM, we know we have the best chance for extended long-term survival for patients with GBM. If we would all want our family members to be on it, and we're -- we have reached approximately 40% of patients today. We know that's not enough. We are continually trying to bend that curve because there is absolutely no reason why every patient should not have the opportunity. But we're also being honest that, that 40% has proven to be kind of a sticky plateau. And so I'd say we're focused on continuing physician education, continuing engagement with the clinician community around clinical trials and further advancing the science, continued engagement with the advocacy community to make sure that patients understand, both on the patient advocacy groups and from their peers how important to this that they have access to Optune. And we're doing the kind of bread and butter execution work, I would say. We are guiding to the fact that there is no magic bullet here. So it is approaching a mature market 10 years post launch and geographic expansion is the easiest lever to kind of unlock that, which we do not expect in 2025. But I will reiterate the point that we're very pleased to have the stability that comes from a sustained $600 million-plus business. Why are -- we are always looking for the unlock of the next phase of growth there.

Okay. Maybe kind of on that point of like the stickiness of this 40% penetration coming off of a year where you -- or maybe a couple of years, you've delivered positive results for LUNAR, METIS, PANOVA, could that create just kind of a Halo effect that gives you some uplift in GBM?

Yes. I mean we feel that, right? I mean just when you go to medical conferences, just the volume of people the booth in the volume of specialties that come and the people like come together and said, "Oh, yes, I've heard about that from somewhere." I've seen somebody in my clinic wearing it. So there is definitely -- Bill always said it's everything is easier the second time around. Now we can say the second, third and fourth time around, right? But I think time will tell how quickly that actually pulls through. We are in lung, for instance, with a completely new customer segment. This is the medical oncologist, it won't be the same with METIS, that is the same customer that treats Optune Gio. But I will say it all helps, right? All of this is validating and you can feel that in the conversations that we have with the clinicians and with the prescribing community.

Okay. So lung, you're in the market now. Can you talk about how you're planning to kind of execute on that launch and just the early feedback you've been getting?

You mean, so far, so good, right? I think we have to be humble enough to understand that we're 10 weeks into the stats that we reported. But what I will say is that early experience has been in line with our expectations, and we expected there to be a material market here, right? There is a significant unmet need for patients who progress on platinum-based therapy who have metastatic non-small cell lung cancer prior to the launch of Optune Lua, docetaxel was really the only option have. And we're getting into the physician's offices. We're getting the appointments to do the education. They're getting certified. They're writing the scripts, the scripts are starting, and you can see that in the early numbers. I think importantly, we're seeing it across both standards of care, so both in combination with docetaxel and ICI. And time will tell, but I will say we're very encouraged. We're not surprised, but we're encouraged to see the uptick, and we look forward to showing progress throughout the year.

And you've kind of talked about this on prior calls, but what's the right way to think about the timelines to securing payer coverage in the U.S.? And how does that tie back to revenue growth.

Yes. No, it's a great question, and it's an important one to understand as you model. So revenue growth is there, but it will materialize in '26. So because we are DME, we do need to negotiate coverage policies directly with the payers before we're able to book the revenue. We will start those payers at risk of that reimbursement in 2025. We're confident we'll get it, but you should not expect material revenue in 2025. You should expect to take about a year to get the commercial payers on and then another year or so to get Medicare on. So you'll see significant revenue from non-small cell lung in 2026. And what you'll see in 2025 is kind of the predictability of that revenue in the future because you'll be able to track the success of the launch and model where that launch curve will go in future years.

And you'll recall, that's exactly how we launched GBM, it was at risk and then we went, received the policies and went back and collected the revenue from the patients that we did treat.

Does that mean that we could see sort of revenue under reflect patients going on. But then once it kicks in, it could almost over reflect patients as you collect on patients in '25 while you're getting paid for patients in '26?