All right, are we live? All right, welcome everybody, and thank you so very much for coming this afternoon to hear an overview of Novocure. My name is Ashley Cordova. I'm the Chief Executive Officer at Novocure, and I'm here today with Christoph Brackmann, our CFO. Excited to share an overview of the company with you and also to take any questions that you may have. I'll start with the standard forward-looking disclosure. We will be making forward-looking statements in here. Let me start with what is Novocure. Since day one, Novocure has been focused singularly on one mission. Together with our patients, we are striving to extend survival in some of the most aggressive forms of cancer. We do that through the development and commercialization of Tumor Treating Fields. Tumor Treating Fields are electric fields that leverage the electrical properties of dividing cells to kill cancer.
We do this through a variety of mechanisms, which I have shown up here f irst and foremost. T he first and foremost of these mechanisms is the antimitotic mechanism. We know that if we can get an electric field inside a cell, we can actually exert a force at a distance and physically dislocate several of the proteins which are critical to cancer cell division. That includes the tubulin spindle. It also includes things like the chromosomal furrow. What we also now know is that the way that that cancer cell death is triggered activates the immune system. We see all the classical signs of immunogenic cell death with calreticulin exposure, with ER stress, with the hallmarks of immune activation.
We now are learning more about the downstream immune activation mechanism, as well as things like the inhibition of DNA damage repair and the effect on the tumor microenvironment. We're able to target specifically cancer cells because the cell membrane acts as a very effective capacitor of electric fields, and it will filter out fields that are not specifically frequency-tuned at the intermediate frequencies we use to treat cancer. That's the mechanism, Tumor Treating Fields, and we deliver this therapy through a medical device. There are two key components to this device, which are shown here on the screen. The first is the field generator that actually generates the field, and it connects to four transducer arrays which are worn. This is the disposable part of the therapy in the region of treatment.
For patients, like you can see on the left here, that are using our Optune Gio device for glioblastoma, they're wearing four transducer arrays on their head. For the Optune Lua patient that you see there on the left, he is wearing transducer arrays under his shirt on the torso. We also can treat in the abdomen with the pancreatic data that we're about to review. We have a solid foundation in glioblastoma where we are NCCN category 1, approved and reimbursed with more than 4,200 patients on therapy now, actually as of the first quarter, and over $600 million in revenue. This is our solid foundation that we leverage to invest in the pipeline and bring this therapy to many, many more solid tumors.
What we are standing on here is a well-established commercial business with an infrastructure that we're able to leverage across indications that has been tried and tested. We have a commercial business that if we were to take away the R&D investment, would be generating about $100 million in cash in its own right, which we are then able to put back into the pipeline, again, to the tune of over $200 million a year. Because we are a medical device, we are uniquely positioned with the intellectual property that we have because we not only have the IP around some of the core mechanisms, but we are also able to patent the evolving medical technology behind the device. Very well positioned on this solid foundation in GBM to bring this cancer to many more solid tumors.
This is why it's such an exciting year and such an exciting time to get to know more about Novocure and Tumor Treating Fields, because we have established this business over the last 25 years, the science and actually the commercial infrastructure in glioblastoma. We now have further de-risked this with three positive randomized phase III trial readouts in non-small cell lung cancer and brain metastases from non-small cell lung cancer, and just this last weekend at ASCO in pancreatic cancer. We are truly entering a new era with a platform therapy. This slide summarizes right here what we're talking about with this platform. As you can see, we have four indications which now have proven to provide efficacy for patients in high unmet needs.
Glioblastoma is our base business where we extend survival, the best chance for extended long-term survival for patients with newly diagnosed GBM. As I noted, more than $600 million in revenue there. We also just launched in the US in non-small cell lung cancer. We got that FDA approval last October for metastatic non-small cell lung cancer post-platinum failure. The launch is going well. We're in the early stages of that ramp, but we're in market today in both the US and Germany, and we're at the regulators in Japan with that indication. We also announced last year positive data in brain mets from non-small cell lung cancer. Again, the first time we've ever seen a therapy that extends the time to intracranial progression, which is the key output you're looking for in the met. That data will be with the FDA later this year.
Pancreatic cancer just this last weekend at ASCO with the first trial ever to extend survival in locally advanced unresectable pancreatic cancer. The data was published this weekend as well and is also preparing for submission to the FDA this year. Both of these we would expect pending approval to be launching next year. We are layering on three additional indications to what is already a well-established business in GBM. That opens up a TAM expansion opportunity of 7X over the next two years with fully de-risked clinical data. GBM business alone, again, established commercial business with more than $600 million in revenue and a TAM expansion opportunity in hand over the next six to eight quarters with de-risked clinical data, along with the pipeline potential of the platform that we continue to invest in.
We think really an incredible opportunity and the right time to pick up your pencils and do research on the company. Because it is the current event and because it is actually such an incredible data set, I want to spend a minute talking about our pancreatic data. This was on podium at ASCO this last Saturday. It was also published Saturday morning in the Journal of Clinical Oncology. What you can see here is the first positive phase III trial results ever in locally advanced pancreatic cancer unresectable. You can see the top line of the Kaplan-Meier curve in purple there. That is the extension of survival, a two-month extension in median overall survival with the addition of Tumor Treating Fields to the current standard of care, which is gemcitabine and paclitaxel.
What you can also see is a one-year survival rate that went from 60% to 68% and a very clean separation of the curve, which lasted throughout the duration of treatment. A lot of positive energy in Buzz. I was in Chicago this week, and I will tell you the energy at the booth, the energy in the presentation room, the energy from the discussant, and also the callout of the publication was all very positive. The physicians understand how unique it is to have positive data in this setting, and we're very excited to see this trial readout. Published in JCO, selected for Best of ASCO, and we are in the final stages of preparing that regulatory filing now to get to the FDA this year. As I noted, we would anticipate pending approval a launch next year.
We also continue to invest in the pancreatic cancer indication, and we have a phase II trial, PANOVA-4 , which we will be reading out early next year, which looks at Tumor Treating Fields in metastatic disease with the addition of atezolizumab to the gemcitabine Abraxane protocol. This highlights the potential to even further improve outcomes with the immune activation and the IO combination. We know that when you activate the immune system, you synergize well with PD-1s, and that is what we are looking to see in PANOVA-4 . Beyond just the overall survival, I think what was also resonating so well with the physicians was the extension in pain-free survival. Pancreatic cancer is a dismal diagnosis just from an overall survival prognosis, but it is also, unfortunately, a very painful disease. The ability to manage the symptoms and the pain is critically important in the treatment journey.
We saw a six-month extension in pain-free survival when you added Tumor Treating Fields onto the standard of care. I will tell you that this particular data point, along with the distant PFS benefit that we also saw, really resonated with physicians and is generating a lot of excitement in the field. We are also excited about this. As I noted, we are packaging this data up for the FDA this year, would expect to get it submitted to regulators around the world and are looking forward to launch in 2026. We are not done with pancreatic cancer. This is truly a platform therapy. What you see here is a snapshot of our pipeline across solid tumors. The first thing I'll point to, these are all very aggressive cancers with high unmet need.
That is where we are uniquely positioned because of the physical modality and the device-based treatment to go where systemic therapies sometimes have a hard time going. For instance, in glioblastoma, where we have the blood-brain barrier, you're often not able to get effective chemotherapeutic agents into the brain. An electric field can penetrate the blood-brain barrier without any problem. We see a similar situation in the pancreas with the stromal tissue, where we are able to enter some of these privileged sites. Hopefully with the combination of IO, be able to bring incremental benefit in some of these tumors that have been cold historically to immuno-oncology. What you can see here in our specific research, we're focused on three clinical harbors. The first is the head, where we have the glioblastoma indication.
We have an ongoing trial that is, we have the approval on our EF-14 data, which is the significant extension, the best chance for extended long-term survival in GBM. We have two trials that are ongoing there, one which is in the patient follow-up stage. This is the TRIDENT trial, which looks at starting Tumor Treating Fields concurrent with radiation instead of waiting to start post-radiation. Can we further extend survival if we begin earlier in the disease state? That trial is fully enrolled. We're in the two-year follow-up window right now, and we would expect to read that data out early next year. We're also running, opening, and enrolling right now our KEYNOTE D58 trial in which pembrolizumab is actually the experimental agent. We're looking at Tumor Treating Fields and temozolomide versus Tumor Treating Fields, temozolomide, and pembro.
Again, looking to leverage the potential to activate the immune system in GBM in a disease state where pembro historically has not shown an extension of overall survival. We are very excited about the continued development in the brain. As I noted, mets, which is lung cancer, but treated in the brain, that data has read out. That was positive phase III data where we extended the time to intracranial progression. We will have that with the FDA later this year. You can see our pipeline in lung cancer and pancreatic cancer below. In lung cancer, on the back of our LUNAR trial, we are now approved in the U.S., approved and launched in Germany, and pending approval in Japan.
We are running another large randomized phase III trial, the LUNAR-2 trial, which looks at the protocol that we took in metastatic disease post-platinum in LUNAR and moves it first line. We are looking at Tumor Treating Fields combined with pembrolizumab for first line metastatic non-small cell lung cancer. I already hinted on the pancreatic trials earlier. The takeaway here is there is a lot going on in this pipeline. This truly is a platform therapy. We believe that we can effectively extend survival outcomes for any solid tumor that we can surround and get a field inside the tumor bed. We are able to fund the research in these indications with the financial strength that is generated from our existing commercial business in GBM and from the top line growth that will come from our future indications. It is a really exciting year.
When we look at where we're going, here are our 2025 objectives. This is a catalyst-rich year. You can see that we are focused on the commercial side, both on sustaining the GBM business, but really driving an effective launch of Optune Lua in non-small cell lung cancer, where we'll be focused on active patient growth both in the U.S. and Germany and pending the approval and patient growth in Japan. We are focused on advancing the pipeline. I've already walked through that here, but we had the successful presentation and publication of the PANOVA-3 data this last weekend. We will have both PANOVA-3 and METIS with the FDA later this year. We are in the patient follow-up period for, again, another large randomized trial in GBM and our PANOVA-4 trial in pancreatic cancer, which will both read out early next year.
Because we are a device, we also have the unique opportunity not only to develop the clinical pipeline, but to invest in product development. You can see three key milestones that we're working on in 2025 on the product side with the launch of the MyNovaCure app and just the evolution of our software ecosystem that supports the device. We are also well through the rollout of a new array for our GBM patients that's lighter, flexible, and more comfortable to wear. We are investing in the final development stages of a lighter, more flexible torso array that will be in market for our torso patients in upcoming years. A lot of exciting catalysts this year.
We are heads down focused on execution, and we could not be more excited about the opportunity that we have with clinical data de-risked in hand to bring this therapy to many more patients with these aggressive tumors that are in desperate need of additional therapeutic options. If I was to summarize the journey on a longer-term scale, we are standing on a solid foundation of 4,200 active patients today in GBM. We are focused on these near-term opportunities of continued support from the GBM business, plus a successful rollout of our Optune Lua launch in lung. When we look ahead just one to two more years, we would expect brain mets and pancreatic cancer to be contributing material top line growth. We look beyond that.
We're looking to a path to profitability and continued investment in the pipeline to bring this to as many solid tumors as we can for these patients with aggressive cancers. With that, I'm going to pause and ask Christoph to come up. We're both going to go over to the table and take any questions you may have. All right, thank you.
Yeah, you mentioned specifically in terms of treatment concurrent, sorry, you mentioned in terms of treatment concurrent with radio or chemotherapy, how much do you see it as a challenge or an opportunity moving up the sort of the treatment path for these patients? Is that an uphill battle for you right now, or is that becoming easier as it's being established commercially?
Mechanistically, first of all, if we zoom out, we know we can be used in combination with any therapy that we've tested so far to date. If you just think about it, this is a physical modality. It can be used on top of whatever the evolving standard of care is, right? We're uniquely positioned to go on top of whatever is commonly used in any disease state. I would say we're always looking to date with either an additive or a potentially synergistic benefit when we go in combination with other therapies. What we know so far in the disease states that we've studied so far is that earlier is better. Because at that kind of first domino, we're an antimitotic that if you can get ahead of the division rate, you're going to have a better effect, right?
A newly diagnosed GBM, for instance, our data is stronger than it was in recurrent. That is the hope with the combination of radiation, that starting three months earlier, you just get the incremental benefit of the earlier start. There are potential synergies that come from the mechanism itself. We do also know that beyond the antimitotic effect and beyond the immune activation, we inhibit DNA damage repair. In our phase II studies today, we see the real potential to have an extended survival simply because you're able to limit the ability for the DNA to self-repair post-radiation when you're wearing the device concurrently with that radiation treatment. That's the promise behind TRIDENT.
At kind of the worst case, we're going to get the additional three months because we start earlier and you just get an extended duration of therapy in those three months. The potential is that we're actually able to make the radiation much better. That's what we'll see when that trial reads out next year.
When you mentioned that trial, that was in pancreatic specifically, or are you now looking at all the solid tumor indications with regards to moving it upstream?
TRIDENT is specifically newly diagnosed GBM that's concurrent with radiation. The pancreatic cancer trial, which is concurrent with atezolizumab, which is Roche's IO, is in metastatic. A later line of therapy in pancreatic cancer.
With different call points, you think you'll be able to leverage your springboard off glioblastoma and the other indications?
Definitely, definitely. We have a sales force built up for medical oncologists with the Optune Lua launch. We think we'll be able to leverage that field force for the pancreatic cancer indication. Similarly, with METIS, our brain mets indication, the field force that's calling on GBM docs should be well positioned there.
Thank you.
Anything? Christoph's here? All right, if no questions, I can talk, I can wax and wane even more about the benefit of our pancreatic cancer indication. I think that's maybe worth spending a moment for those on the webcast because we're getting a lot of questions, I would say, about how we think this will be adopted in pancreatic cancer. Let me actually plant with myself that same question, and then maybe Christoph, I'll plant with you about how we think the path to profitability.
Because I will say those are two of the questions that we are hearing a lot, right? First of all, this pancreatic data is meaningful. As I said, I was at Chicago this last weekend, and it was honestly really fun because the buzz was there. The physicians are reacting very well to this data. They have not seen positive survival in pancreatic cancer in this locally advanced setting. In the unresectable locally advanced setting, they've never seen it, right? They are just not used to these positive clean Kaplan-Meier curves. Again, the extension and pain-free survival is really resonating as well. For the physicians that were coming up, the types of questions we were getting are, how can I get the experience and the awareness of how to incorporate this device into my practice?
Not whether or not the data is strong or whether or not this, it clearly provides a benefit. The questions are now, how do I learn about how to use this device? This is where the established GBM commercial business provides a really good platform upon which we can launch. First of all, we know how to do this. We have a team of device support specialists that actually deliver the device to the patient. They train the patient in their home, and they're actually there to provide technical support, not medical support, but really technical support for any questions that the patient may have along the treatment journey throughout their treatment of care. They're also helping them monitor their usage because there's no half-life to an electric vehicle, we say.
We know that for it to be working, the device has to be on, and the usage is important. We take care of all of that. We also take care of the billing and the revenue operation side for the physician. It is not a burden on the physician's practice, but the physician itself has to learn that, right? They have to go through that first prescription and get the experience with actually how the start happens. They send the script to us, and then they need to get, they need to learn that system. I'll mention again, we know how to do this in those physicians. Once they have that positive first experience, they become kind of a well of support amongst the community to say, I've tried it, and I know how it's working, and it's quite easy, and their support staff is great.
That is really our awareness and an adoption opportunity, I will say. I will not even say challenge because we are able to leverage what we have done in GBM. We are able to leverage the radiation oncologist on the tumor board to help spread that word. That is the work that, pending approval at the FDA in pancreatic cancer, we will be out sharing with all the physicians. Not just the data, but how easy it is for them to get these patients started on the device and for the patients to incorporate it. Actually, the quality of life benefit that the patients see as well. This is counterintuitive because the patients have to integrate a device into their life.
Because we are keeping the disease at bay and we are doing so much to manage the pain, the quality of life of these patients does go up, and we see a benefit in global health status. I think that's really the opportunity and the work of our teams to make sure that physicians are able to understand and that patients are able to talk to other patients about how they incorporate this in the device. We're doing this today in lung cancer, and we'll replicate that same model in pancreatic and mets. I pre-planted a question to you about what about profitability?
I will talk about profitability in a minute, and I will just emphasize a little bit to what you said, Ashley, because I was sort of on the other side and looking externally at the company not too long ago. What I saw is basically a company coming from one indication, being in one indication commercially for 10 years, and now having the opportunity with clinically de-risked data to approach three new indications. What I underestimated is how much value there is in the strength of the base business that we have. We do $600 million in revenue last year, if you look at last year, right? We still have growth in this business. It is a complex business across a couple of countries.
This is a really robust capability underlying. In particular, FieldForce is maybe something that more companies have, but the device specialists that we have that basically work directly with patients, that is a fairly unique capability, as well as the revenue operations team that we have, the reimbursement team that works directly with payers is also a very strong capability. It is very clear it is not being built in one or two years. This is sort of pressure tested and really, I would say, a very well-working machine. Now, to profitability. First, I would say it is something that we are very focused on. We have a path to profitability. We see the value in profitability.
What we need is additional contributions from the new indications. Because we are in the device world and not in the pharma world, there is always a lag in terms of the revenue coming in from launching the new indications. What we said on the lung launch, which will be true for the other launches as well, is because we will have to work on getting the new indication on medical policies from a payer perspective as well as get Medicare coverage. It will take us about a year to work with commercial payers and about another year to work with Medicare to get more standardized approval for our therapies. What that means is that this year, we are in a demand generation year for the lung launch, and we expect more material contributions from a revenue perspective next year.
When we launch, or that's our expectation, obviously, pending approval, when we launch the other indications next year, we will have the revenue contributions coming in with a year lag. From that perspective, this year is really a transition year. Next year, we expect sort of from the new indications, more material revenue contributions to hit our revenue line, and that is basically providing us the power of profitability.
Yeah, I mean, this is the power of layering on the additional indications, right? Demand generation this year in lung, top-line growth next year from the lung indication, and that then fuels the flywheel. We really do think it will become a flywheel of kind of bring on each, the demand generation of each additional new indication will generate that top-line growth, which will flow to the bottom line, which we can then reinvest back into the pipeline and keep the flywheel going. Please, please.
When I asked earlier about sort of springboarding or leveraging glioblastoma, but now with regards to profitability, are there real economies of scope and scale as you expand into other indications? Where are those manufacturing, regulatory, what?
Yeah, I can.
Yeah, definitely.
Yeah. I mean, first of all, the capability we talked about that are established, we have a FieldForce that where we build a separate FieldForce for now our indication in non-small cell lung cancer. That has been built. That will also be the FieldForce that we will use for the pancreatic cancer launch, right? Similar, and you mentioned that before, Ashley, on the GBM side, we have a FieldForce, and they will also then take on brain metastasis. That's one thing. Now, the revenue reimbursement team that we have, the more claims we'll have, I mean, there is some growth to be expected, but there is significant economies of scale as well as on the device service specialist team. On these core capabilities, as well as when we think more broadly on our SG&A spend, we expect significant economies of scale.
The only other thing I would maybe add there is the geographic overlay. We're talking indications right now, but we're also well-established in all of the kind of developed, high-value paying commercial markets. You only have to build that once. There's a lot of economies of scale. We're direct in every market that we are in, with the exception of China, where we partner with Zai Lab. We're direct in Japan, and we are well-established, as I said, in kind of the large markets in Western Europe and Japan that you would expect to be paying for high-value oncologics.
Yeah, I mean, guys, we're biased, but we think there is really such an incredible opportunity here. We know that we have the data in hand, and we're at just the right moment. I think that's our message to everybody listening. Now is the time to pick up your pencils here because these catalysts are going to come fast and furious, and we're committed to be heads down and execute against them. Thank you very much. All right, thank you.