All right. Hello, everyone. Thanks for joining us. My name is Jonathan Chang. I'm part of the Leerink Partners' equity research team. It's my pleasure to host the management team of Novocure. We have with us today CFO Christoph Brackmann and Adam Daney, the Associate Director of Investor Relations. With that, let's get started. Thank you both for joining us.
Thank you very much. It's great to be here.
Would you like to briefly introduce the company and maybe also tell us about why you joined the company?
Yeah, yeah, yeah. Thank you. Novocure is a medical device company founded 25 years ago, based on the core idea to target the electrical properties of cells, and more specifically, cancer cells. The company mission is to strive to extend survival for some of the most aggressive forms of cancer. We do this through our innovative technology called Tumor Treating Fields, or in short, TTFields. What is TTFields?
It is a non-invasive treatment modality whereby an electrical field is generated by a portable medical device. This electric field is delivered to the tumor through arrays. It is always four arrays, two pairs working together. We can tune the electric field specifically to the tumor so that we impact cell division of cancer cells but leave healthy cells unaffected. We do not add systemic toxicity to the treatment.
Now, we, from a commercial perspective, have focused on GBM as the primary indication over the last, essentially, decade. We now have had three positive phase III readouts over the last two years. The first one for non-small cell lung cancer, metastatic non-small cell lung cancer in the second line, the second one in brain metastases from lung cancer, and the third one in pancreatic cancer, locally advanced and unresectable pancreatic cancer.
For lung, we have received approval in Q4 of last year. For the two other indications I mentioned, we expect to submit for approval in the course of this year. Cumulatively, these three additional indications represent a TAM, total addressable market, that's about seven times the size of the GBM market that we had in the past decade. We're very excited about that.
You mentioned I joined the company as CFO in January this year. Really, for me, it was two things. It was, one, the mission of the company to focus on the high unmet medical need cancers was one compelling factor. The other one was to be able to have three clinically de-risked indications to add on kind of an established infrastructure that we built for GBM. I think it's an incredible opportunity to create value for patients, employees, and shareholders.
Great, great. Thank you for the introduction. First, more specific question. Across the different clinical studies to date where you've tested Tumor Treating Fields, how should we think about the potential utility of this device? What would you say have been the key learnings in terms of where the device is more likely to succeed or not, in terms of tumor types, where the device is placed in the body, the stage of disease, whether it's combination treatment, and what?
Yeah, maybe so a couple of things.
There's a lot of layers there where we want to take that.
Let me try to go at it step by step. One, our therapy is unique in the sense that we can impact cancer cells almost anywhere in the body that we can surround with an electric field. That excludes certain types of blood cancer or cancers of the long bone where we cannot penetrate with electric fields. Broadly speaking, any solid tumor that we can surround with electric fields is where we can have an impact on cancer cells with interfering with the cell division and ultimately leading to cancer cell death. The other point is we are doing clinical, we are a medical device company, but we are doing clinical studies, as you would expect from a pharmaceutical company. We have a wealth of clinical data that we can look at.
We have looked or we combine Tumor Treating Fields with multiple systemic agents. We combined it with chemotherapy, radiation therapy, and with immune checkpoint inhibitors. Based on the clinical data we have, I'd emphasize two key learnings. One is the earlier and more consistent use of TTFields in the patient journey generally leads to better outcomes.
The second one is that there is a potential multiplier effect when TTFields are used together with immune checkpoint inhibitors, which, when you look at our clinical studies currently ongoing, three phase III trials, two phase II trials, all of them are centered around these key learnings, either looking at TTFields earlier in the treatment process and/or combined with immune checkpoint inhibitors.
Got it. You mentioned using the device earlier and more consistent. What would you say are the key considerations as it pertains to patient compliance and safety and tolerability profile of the device across the different studies today?
Yeah. I mean, a couple of data points. One, we do not have a half-life with our therapy. If it is on, it is on. If it is off, it is off, right? Generally speaking, the advice is to use it more than 18 hours a day. That is also the recommendation for clinical studies. The other point I would say is what is sort of unique is we do not add systemic toxicity. The adverse event that you have is skin reactions or skin irritations that in most cases can be well managed.
Got it. What is the impact of the different skin adverse reactions that we should be thinking about? Does that change based on where you place it on the body and the tumor type?
It's really driven by, I mean, the skin irritation is driven by the array that needs to be placed on the skin. From that perspective, it doesn't differentiate that much on where it is on the body.
Got it. All right. How about starting with GBM as our first indication? What does the commercial picture look like for GBM today, and how could this grow in the future?
Yeah. So look, GBM is, for us, a fairly established indication. Directionally speaking, we are focused on it from a commercial perspective since a decade. We have treated more than 35,000 patients to date. We have currently more than 4,000 patients on therapy across 10 markets globally. For us, the most important markets are the U.S., Germany, Japan, and France.
In GBM, we have basically, in the markets that we are active, broad reimbursement established. We have best survival data in GBM. A very robust base business. Last year, we generated $600 million of sales in that business. From a penetration perspective, in major markets, we are close to 40% penetration, which on the one hand offers 60% to go after, right? On the other hand, the 40% have proven to be a fairly sticky plateau for us over the last couple of years.
While we are focused on growing that market, we also believe it's in an advanced stage or more mature stage at this point. We are investing in the market also from a clinical study perspective. We have a study; it's our TRIDENT study where we look to add Tumor Treating Fields early in the patient journey, about two months early in the patient journey, to add it to chemo radiation.
That study is fully enrolled, and we expect it to read out from a top-line data perspective first half of 2026. We have a large Phase III trial currently enrolling, D58, which is looking at adding pembrolizumab to our Tumor Treating Fields treatment regimen. It's sort of our base business. We are focused on it. We are focused also on growing it. Having said that, we reached with penetration of 40%. It has proven to be somewhat of a plateau for us.
Got it. How should we be thinking about 2025 revenue in GBM?
Yeah. We do not officially guide, but the forward-looking comments that we gave is that we expect a low, mid-single-digit growth rate. When you look at our growth last year, we had very significant growth last year. There were two drivers last year. One is we had significant growth from France. Total growth last year was $96 million. $44 million came from France.
$42 million came from increased approval rates in the U.S. We believe that the growth in France now, because the size of the market is almost reaching the size of Germany, which we always said would be sort of what we would expect for that market, is going to level off. From an approval rate or net price impact perspective as well, we do not expect approval rates to further grow from the basis that we are currently. Versus the base of last year, we expect a growth of low, mid-single digit.
Understood. Let's switch to some of the expansion or growing opportunities. Can you discuss the early launch in non-small cell lung cancer and what you're seeing on that front?
Yeah. We had approval in the U.S. October 15. Essentially, the next day, we started to promote the product. We have a field force of 50 territory managers promoting. I have to say, with the early data, we are very pleased. We reported that we had, since we had the approval, 52 scripts that we collected in Q4 of last year. We had 20 active patients on therapy at the end of the year. The launch is ongoing. What we said is this is a launch in the med tech area where we expect it to be more of a linear growth curve. That is what we are seeing unfolding. Maybe a couple of points or additional color on the launch. One is we are pleased to see a broader prescriber base.
This is not just a handful or a two-handful of prescribers, but it's much broader than that. Two is we see a broad use of the label, so about 50% with docetaxel, 50% with IOs. One other important point is that we, which was a point of contention because, if you recall, the standard of care changed during the trial to earlier use of IOs. The question was, will we see IO re-challenges in second line where we were approved? We definitely see IO re-challenges in actually a majority of the patients.
Got it. What has the feedback been so far from physicians and patients?
Yeah. Look, it's early days, but the feedback so far has been positive. It's a treatment option that doesn't add systemic toxicity in a world where toxicity is part of the treatment regimen, typically.
Understood. Are there any lessons from the GBM experience that you think are relevant for the lung cancer launch?
Yeah. Maybe from a bigger or larger perspective, zooming out a bit, I think the GBM business is a robust business in itself that we built. We built it not over one or two years, but we built it essentially over the last decade. What I mean with that is we not only build a field force. We also build a field force specific for lung. We have what we call device specialists because we have a direct contact with our patients.
We have a team that is taking care of the patients, onboarding the patients, training the patients with the product. We also have a revenue operations team that is basically talking to payers. To your question, from a, I think, bigger perspective is we know how to work with prescribers. We know how to work with payers. We know how to serve patients. I think that is what we leverage now for the lung launch more broadly.
Understood. How should we be thinking about the potential contribution of lung cancer to the 2025 revenue?
Yeah. So look, the focus this year is on generating demand, educating physicians. From a revenue perspective, because we are DME, we do not get automatic reimbursement. The process is basically that we need to establish reimbursement and contracting with payers and then contracting with CMS.
What we said is this year is really about demand generation and working on initially through an appeals process to get coverage. We are launching or we are starting patients on label at risk and are working on reimbursement in the background. That will come on with a delay. What we said is we expect more material revenue contributions from the lung launch ramping up in the next year.
Got it. How are you thinking about the peak potential for the device in lung, at least in the currently approved setting?
Yeah. Look, in the currently approved setting, the total addressable market we estimate to be 30,000 patients. Now, one important data point is the duration in the trial. In the commercial setting, we have to see how that works out. In the trial was 4.5 months, which is roughly half the duration that we see with our GBM patients. If you put that together, we see the current label to be around twice as much as GBM from a total opportunity perspective.
Understood. Let me check to see if there are any questions from the audience before I move to some of the other treatment settings. All right. Maybe switching to METIS and the brain metastases opportunity. What are the next steps here and the status and timelines of the potential regulatory applications?
Yeah. For METIS, the next step would be two next steps. One is publication of the data in a peer-reviewed journal. Two is submission of METIS for regulatory approval.
Got it.
Let me just add on real quick. I would say on that point, we do have breakthrough device designation for METIS and PANOVA, which we'll get to momentarily. We are involved in pre-submission discussions with the FDA right now. We do expect to file that PMA in 2025.
Got it. Got it. On the planned publication of the METIS results, what could we learn from this versus what we've seen in the ASCO presentation?
I think it will be consistent with the ASCO presentation. Maybe just to remind everyone, what we saw in the study is a clear and sustained benefit in the time to intracranial progression. Also, very importantly, we maintained quality of life and neurocognitive capabilities, essentially. Yeah, we're very excited about the next steps. Particularly, one is obviously publication, but also filing in the course of the year.
Understood. How big could the METIS opportunity be?
From a total addressable market perspective, we estimate METIS to be 16,000 patients, which is about twice as large as GBM.
Got it. Maybe switching over to PANOVA-3 and the pancreatic cancer opportunity. You've guided to presenting the study results at a medical congress this year. Can you provide any more color on when we might see those results and what we could learn from the full presentation versus just what we have to work with now, which is the press release with the top-line disclosure?
Yeah. Look, what we said is we are looking forward to presenting the full data set at an upcoming medical congress. We believe it's important data. A large medical congress would be the right forum to do so. In terms of what to expect, it would be visualization of overall survival curves and more info on secondaries.
Got it. What are the timelines for potential regulatory submissions based on PANOVA-3 ?
It's in the course of the year.
OK. How big could the PANOVA-3 pancreatic cancer opportunity be?
Yeah. From a total addressable market, we estimate that to be 15,000 patients in the locally advanced setting. There are 60,000 patients diagnosed with pancreatic cancer on a yearly basis. I'm just talking the U.S. now. About 80% of those are unresectable at the time of diagnosis. A third of that would be in the locally advanced setting. That is how we get to 15,000 patients.
Got it. Now, you're also evaluating the device in PANOVA-4 . And I believe those data are expected in 2026. How does PANOVA-4 compare to PANOVA-3 ?
Yeah. Two important differences. PANOVA-4 is looking at the metastatic population. This would be, what I said before, about three times larger than the locally advanced. It is also adding an IO to the treatment regimen. Maybe just to mention, this is a phase II study.
Got it. What would you say are the reasons for confidence in the PANOVA-4 study?
One is that we have the results from PANOVA-3 . We know that TTFields together with gemcitabine works. That's one. Two is we have clinical data that shows that the use with IOs potentially has a positive impact. The question is whether we are able to open up the stromal tissue to be able for the IO to have a positive impact.
Got it. Adam, do you agree or disagree with everything he's been saying so far?
I agree. I think, obviously, the greatest indicator is the great success we saw in PANOVA-3 . We have shown the ability to impact pancreatic tissue. I think it's a really strong indicator for PANOVA-4 . We're very excited to have that data out next year.
Got it. Let me check with the audience, see if there are any questions from the audience. All right. The next question, now this will be a CFO question. Maybe my final topic. Can you discuss where you are in terms of cash today and how you're thinking about the road to profitability in the future?
Yeah. So look, last time we reported, we had cash of $960 million. We also have a convertible note outstanding. It is due in November of this year. We have $561 million outstanding. Now, our thought on the convertible note, we get that question often, is we will pay that down as late as we can because we basically have a coupon of 0%. We have a positive spread.
The other important point is we have a credit facility that we put in place last spring, last year, over $400 million. That is in four tranches, each $100 million. We pulled one last year for $100 million. We will have to pull another one this year for $100 million. The two other ones are optional. We believe that with the funds available that I just talked through, we have a path to profitability.
Got it. Then just last question from me. What are the key 2025 catalysts and milestones that investors should be looking for?
Yeah. So look, I think we have a very catalyst-rich year this year. Obviously, the first one would be the lung launch, where you will be able to track us on a quarterly basis. We'll provide color how the lung launch is going. It's something that we are very focused on. It's the first launch for us in a major new indication since essentially a decade.
It's very important for us to execute well on this. Two is the presentation of PANOVA-3 , the full data set, at an upcoming medical congress. Obviously, publication for both METIS and PANOVA. Then regulatory filings for both METIS and PANOVA. Yeah, we believe that we'll have something important to say on a quarter-by-quarter basis.
Excellent. With that, I think we're going to wrap it up. Thank you guys very much for joining us.
Yep.