NovoCure Limited (NASDAQ:NVCR) Q1 2025 Earnings Call Transcript

NovoCure Limited (NASDAQ:NVCR) Q1 2025 Earnings Call Transcript April 24, 2025

NovoCure Limited beats earnings expectations. Reported EPS is $-0.31, expectations were $-0.47.

Operator: Good day, and thank you for standing by. Welcome to the NovoCure Limited First Quarter 2025 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question and answer session. To ask a question during the session, you’ll need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your host for today’s conference, Ingrid Goldberg. Please go ahead.

Ingrid Goldberg: Good morning. And thank you for joining us to review NovoCure Limited’s first quarter 2025 performance. I’m on the phone this morning with our Executive Chairman, Bill Doyle, CEO, Ashley Cordova, and CFO, Christoph Brackmann. Other members of our leadership team will be available for Q&A. For your reference, slides accompanying this earnings release can be found on our website www.novocure.com, on the Investor Relations page under Quarterly Reports. Before we start, I would like to remind you that our discussions during this conference call will include forward-looking statements and actual results could differ materially from those projected in these statements. These statements involve a number of risks and uncertainties, some of which are beyond our control and are described from time to time in our SEC filings.

We do not intend to update publicly any forward-looking statement except as required by law. Where appropriate, we will refer to non-GAAP financial measures to evaluate our business, specifically adjusted EBITDA, a measure of earnings before interest, taxes, depreciation, amortization, and share-based compensation. We believe adjusted EBITDA is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material noncash items, and best reflects the financial value generated by our business. Reconciliations of non-GAAP to GAAP financial measures are included in our press release earnings slides and our Form 10-Q filed with the SEC today. These materials can also be accessed from the Investor Relations page of our website.

Following our prepared remarks today, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.

Bill Doyle: Thank you, Ingrid, and good morning. For twenty-five years, our mission at NovoCure Limited has been to extend survival for patients with some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields. 2025 is set to be a defining year for NovoCure Limited as we move from a single indication treating patients with GBM to becoming a multi-indication oncology company. With five successful phase three clinical trials in hand, our focus is squarely on execution, particularly on the regulatory and commercial fronts. This morning, we will discuss early feedback from our non-small cell lung cancer launch, provide commercial and clinical pipeline updates, and then turn to our quarterly financial performance.

But before we dive into the quarterly updates, I would like to highlight two items of breaking news. On Tuesday morning, we announced that OptuneLua received European CE Mark approval for the treatment of metastatic non-small cell lung cancer. We were pleased to receive a broad label which includes concomitant treatment with both immune checkpoint inhibitors or docetaxel. Our team in Germany is ready to launch, pending local registration. Also, we were pleased to announce yesterday that the results of our Panova three, our successful phase three clinical trial in unresectable locally advanced pancreatic cancer, were accepted for presentation at the upcoming American Society of Clinical Oncology annual meeting. Data from the Panova three trial will be presented on Saturday, May 31, by lead investigator Dr. Vincent Pacozzi of the Virginia Mason Medical Center as part of the gastrointestinal cancer oral abstracts clinical session.

That evening, at 7 PM central time, we plan to host an investor event with a live webcast to dive into the results with Dr. Pacozzi and members of our management team. Pancreatic cancer is one of the deadliest forms of cancer, with an estimated five-year survival rate of only thirteen percent and a growing global incidence. Panova three is the first and only phase three trial to demonstrate a meaningful survival benefit in locally advanced pancreatic cancer. Presentation of the Panova three data on the main stage at ASCO will bring important visibility to the potential for Tumor Treating Fields to meaningfully bend the survival curve in pancreatic cancer. We look forward to discussing the Panova three results with clinicians and investors next month.

I’ll now turn the call over to Ashley to provide further updates on Q1.

Ashley Cordova: Thank you, Bill. It has been an exciting quarter for our team, and I am proud of the milestones we’ve hit already this year. Our mission has never felt more urgent as we expand our reach to more patients facing some of the most challenging solid tumors with significant unmet needs. Last October, we received PMA approval for OptuneLua in our newest indication, metastatic non-small cell lung cancer, and immediately initiated our US launch. After a strong start, we remain highly encouraged by the early commercial indicators. In the first quarter, we received ninety-two non-small cell lung cancer prescriptions and ended the period with sixty-two patients on therapy. We also had forty-four mesothelioma patients on therapy for a total of one hundred six Optima active patients.

These early results in non-small cell lung cancer reflect our focus and disciplined launch strategy centered on reaching the right physician for the right patients at the right time. Our initial efforts have concentrated on engaging physicians most likely to adopt OptinLua, those open to novel treatment modalities and eager to engage with us in advancing patient care. Many of these physicians operate in community settings where the majority of non-small cell lung cancer patients are treated. We’re seeing encouraging breadth in prescriber interest. As of March 31, we have received prescriptions from 93 unique prescribers, with sixty percent of these prescribers new to Tumor Treating Fields therapy. Many come from institutions that had never prescribed Optune Geo GBM.

General medical oncologists represent the largest share of prescribers, and radiation oncologists are emerging as important users and advocates. Our FDA label enables patients to use Optinlua together with either a checkpoint inhibitor or docetaxel following progression after prior exposure to platinum chemotherapy. This aligns well with real-world treatment patterns. While newer biomarker-specific therapies dominate headlines, only about thirty percent of lung cancer patients qualify for these options. Most patients receive a platinum chemo plus an immune checkpoint inhibitor in the first line, positioning them squarely within our on-label population. We see three primary patient populations driving early adoption. First, there are those patients who responded to first-line ICI and platinum chemo but show early signs of relapse.

This is the smoldering progressor population we have referenced in the past. Second, our patients who received ICI and platinum chemo on the first line but who did not respond have progressed and are motivated to seek second-line treatment for rapidly progressing disease. Finally, there are low or non-PD L1 express that received platinum-based chemo as monotherapy in the first line, have progressed, and are looking for a better alternative to long-term chemo monotherapy. Each of these groups represents sizable patient populations with limited treatment options prior to the launch of OptuneLua. Combined, we believe these groups represent approximately 30,000 eligible patients in The US annually. Encouragingly, our early adoption includes patients from all three populations.

Of the sixty-two non-small cell lung cancer active patients on therapy at quarter end, there was roughly a fifty-fifty split between concomitant ICI and docetaxel use. As of March 31, over ninety percent of the patients who were prescribed Optomua were previously treated with an immune checkpoint inhibitor, a clear indicator that physicians are comfortable with continued ICI treatment in the second line. Beyond reaching the right physicians and the right patients, our third focus for launch success is treating patients at the right time. The right time means three things: reaching physicians and patients that are motivated to move quickly, starting OptinLua at the first sign of progression, and minimizing use as a salvage therapy. Our positioning has been successful thus far.

Through the end of Q1, approximately fifty percent of the prescriptions received were for Optima in second-line use, with another twenty-five percent prescribed for third-line use. As Bill mentioned, earlier this week, we were thrilled to announce CE Mark approval for the treatment in metastatic non-small cell lung cancer in European markets. Our team is launch-ready. As a reminder, we have an Optimala Salesforce in place in Germany that has been detailing Optumlua for mesothelioma over the prior year in preparation for the non-small cell lung cancer launch. We have initiated the local registration process in Germany and are preparing to launch Nauzau’s twelve lung cancer in the coming weeks. This is an important milestone, and we are excited to add a second market to drive Optimala growth.

Looking ahead, regulatory review is ongoing and constructive in Japan. We’ve begun building out our Japanese commercial team in anticipation of a launch in Japan later this year. Around the globe, we anticipate adoption to follow a durable medical device-like curve that is linear and sustainable rather than exponential. We remain confident in our ability to expand access and drive top-line growth in the coming years as momentum builds across clinical, commercial, and payer communities. Turning to our Bedrock GBM Q1 performance was strong, with a record four thousand one hundred sixty-two active patients globally. We saw continued year-over-year patient growth, particularly in France and Japan. Our GBM business serves as an important springboard for product and service enhancements that will be leveraged across future indications.

The most recent example is the rollout of the HFE array, which is now standard for all new GBM patients in all active markets. While the HFE array is designed for head applications, feedback from patients and caregivers on the new materials and design will be invaluable in the design of our next-generation torso and abdominal arrays. We also recently launched a patient app available on both the iTunes App Store and Google Play. Our app is an exciting advance for patients as it allows them to follow their individual daily usage rates, order new supplies at the touch of a button, and troubleshoot any issues with the device. We recently cleared 1,400 app users in The US, representing a significant portion of the 2,100 plus US active patients. Next generations of the app with greater functionality and international access are in the design phase now.

Personal app-based tools not only improve the patient experience, but they also set the stage for scalable, high-touch services as we enter a multi-indication feature. Turning to regulatory catalysts, PMA submissions for both METIS and Panova three remain on track for 2025. Our modular PMA shell for the Metis application has been approved by the FDA. Modules one and two were submitted earlier this month and are now under FDA review. We are also making steady progress towards submission of a PMA for locally advanced pancreatic cancer based on the Panova three data, including active pre-submission engagement with the FDA. These early discussions are helping shape the structure and content of our formal filing and will support a smooth review process.

On the clinical front, we are focused on studying applications of tumor treating fields that could further expand our addressable markets in pancreatic and lung cancer, maximize the duration of therapy, and broaden the data supporting use in GBM. Our pipeline is largely focused on studying the concomitant use of tumor treating fields and immune checkpoint inhibitors, a regimen that continues to show immense promise across indications. We are opening sites and enrolling patients in our phase three KEYNOTE d 58 and LUNAR two trials and our phase two LUNAR four trial. Our phase three TRIDENT trial and our phase two PANOVA IV trial are both fully enrolled and in follow-up, with top-line data readouts expected in the first half of 2026. We believe our clinical pipeline provides us with the potential to deliver Tumor Treating Fields therapy to tens of thousands of additional patients annually.

In summary, this is a moment of meaningful momentum for NovoCure Limited. After years of serving patients in a single commercial indication, our footprint is expanding to new indications, new centers, and new physician specialties. Our lung launch is progressing, our pipeline is advancing, and our commitment to patient-forward innovation is stronger than ever. We look forward to updating you on our progress as the year unfolds. With that, I’ll turn the call to Christophe to discuss our financial performance in the quarter.

Christoph Brackmann: Thank you, Ashley. 2025 is off to a strong start. The first quarter, we generated $155 million of net revenue, an increase of 12% from the first quarter of last year. This was primarily driven by 11% growth in active patients and, to a lesser extent, from reimbursement improvement. We grew active patients compared to the prior year by 40% in France, 17% in Japan, 10% in Germany, and 4% in The US. We collected $1.5 million from Optune lure claims in the quarter, which was split roughly fifty-fifty between MPM and NaClc. It’s encouraging to see the initial results of our NACLC reimbursement efforts in the form of approvals and positive outcomes from appeal. As a reminder, according to US GAAP, we recognize revenue by applying our estimated future collection rate at the time of billing.

Since NACLC is a new indication, we will need to build a collection track record to support a collection rate estimate to enable revenue record upon billing. Until we build a track record, our revenue from non-small cell lung cancer claims will reflect cash collections in the period. Our gross margin for the quarter was 75% compared to 76% in the prior year period. The reduction of gross margin was primarily driven by the rollout of our HFE arrays and the NACOC launch, where we are treating unlabeled patients at risk prior to establishing broad reimbursement. This is consistent with discussions in prior periods, and we expect these headwinds to lessen as we establish reimbursement in non-small cell lung cancer and lower the cost of the new HFE arrays.

Additionally, we anticipate some gross margin headwinds due to the evolving tariff landscape. Our most significant exposure is from the import of arrays into The US from Israel, with lesser potential impacts from imports from Mexico and Europe. If tariffs return to the increased rates announced before the current ninety-day pause, we estimate import duties could impact our 2025 cost of goods by up to $11 million. In a scenario where this pause is extended through year-end, we estimate that annual cost of goods could be impacted by up to $8 million. We are driving several supply chain optimization initiatives to mitigate the incremental headwind from tariffs. Moving down the P&L, research and development costs for the quarter were $54 million, an increase of 4% from the same period in 2024.

We do not expect R&D expenses to take a material step up this year as we ramp down spending on some large Phase III trials and ramp up spending on others. Sales and marketing expenses in the quarter were $56 million, an increase of 1% from Q1 of last year. Our thoracic sales forces in The US and Germany are fully staffed and reflected in our Q1 operating expense. Looking ahead, we expect some incremental expense primarily from marketing and in preparation for launch in additional countries. G&A expenses for the quarter were $45 million, an increase of 13% from the first quarter of 2024. This increase was primarily due to a one-time $2.3 million expense to retire production line related to supply chain optimization efforts and personnel and professional expenses to support the NSCLC launch and potential additional launches.

We believe our current G&A footprint can be leveraged to treat patients across multiple indications so that we would expect only modest increases in spending in the foreseeable future. Net loss for the quarter was $34 million, with a loss per share of $0.31. Adjusted EBITDA in the quarter was negative $5 million, and our current cash and investment balance at the end of Q1 was $929 million. Reaching profitability is a key focus for us. We prepare for multiple potential new product launches in the coming years. While investing for growth, we are determined to keep our expenses measured, and we believe we can leverage many areas of our current infrastructure to meet the needs of multiple launches. With the cash and short-term investments currently on our balance sheet, as well as the capital available through our credit facility, we believe that we have the funds necessary to retire our convertible note due in November and bridge to new revenue streams from future indications.

To close, I’d like to take a step back and reflect on my first quarter in role. This is an incredibly exciting time for NovoCure Limited. As we pivot from a single indication to a multi-indication company, Tumor Treating Field therapy has been clinically derisked in several important cancer indications through large randomized phase three trials. We have built a sustainable business that provides the financial strength to launch in these new indications and pursue an ambitious clinical pipeline to further expand our reach. Our infrastructure and institutional knowledge can be leveraged for growth in the coming years. We are confident in our technology, in our team, and in our ability to reach many more patients in need and drive substantial revenue growth.

We look forward to updating you on our progress as we do so and to see many of you at ASCO. We will now turn to our operator for your questions.

Q&A Session

Operator: Star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Our first question comes from Larry Biegelsen with Wells Fargo.

Larry Biegelsen: Good morning. Thanks for taking the question. Congrats on a nice quarter here. Bill or Ashley, I wanted to ask one on non-small cell lung cancer, one on Panova three. So just starting with non-small cell lung cancer, we’re trying to benchmark the launch to newly diagnosed GBM just to, you know, as a benchmark. The scripts look like they’re about twenty-five percent of newly diagnosed GBM scripts at the same time post-launch. Active patients about two-thirds. How are you viewing the ramp of non-small cell lung cancer after I know only two quarters but versus newly diagnosed GBM? You know, we’re just trying to understand how big non-small cell lung cancer can be relative to GBM. Any color on how you’re seeing the curve so far? And I had one follow-up.

Ashley Cordova: Yeah. Sure, Larry. This is Ashley. Good to hear from you. And I’ll actually add Frank to provide some color on the launch after the answer. The short answer is this is hard to tie it to newly diagnosed GBM, Larry, and I know that’s hard because you want the analog, but it is a different setting. This is general medical oncologist. This is an oncology community that now knows tumor treating fields because we’re not launching in our first indication. And it’s, you know, it’s just a different patient segment. So the better anchor I would say is to look at this population of the 30,000 annual eligible patients, to look at the 93 unique prescribers that we’ve built, and to say that we have the Salesforce in place that we need to be able to detail the high decile physicians that are prescribing a non-small cell lung cancer.

And you, I would, you know, I know that’s not a direct analog to newly diagnosed GBM, but I think our trajectory in prior quarters is the better analog, and we’re very pleased where this has gone post-launch and through Q1. And then maybe I’ll pass it to Frank to add some color.

Frank Leonard: Yeah. Hi, Larry. I’ll just say that, you know, what we said in prior quarters remains true that we see a high unmet need. This is a population that does not have a good treatment option, and Tumor Treating Fields is perceived as bringing clinical value to that patient population. And we’re seeing in the numbers that we do have ninety percent of the patients who have been previously treated with immune checkpoint inhibitors, and that, you know, again, gives us real confidence that there’s a big population out there to go and pursue. And just one kind of story I’ll add to give color to what Ashley said about the fact that the community does at least know tumor treating field, we were able to have OptuneLua added to the, you know, drop-down ordering menu at one of the largest in the electronic medical record of one of the largest private practices in The US.

And that when we did that for GBM, it took us about five years to get to that point, and it took us about five months in the lung cancer launch.

Larry Biegelsen: That’s very helpful. And then switching gears to PINOVA three, Ashley, help set expectations for the presentation at ASCO. In addition to the overall survival curves, what data do you think will be important to physicians such as response rate, percent of patients who become surgically operable, and how are you gonna address pushback from academic physicians that you use gem or Braxane in the control arm and not FOLFIRINOX in the control arm? Thanks.

Ashley Cordova: Great. So I would just remind everybody that we were very pleased to have our labor abstract accepted for oral presentation on Saturday afternoon at ASCO. So this is, you know, really prime podium time for our Panova three dataset presentation. And I’ll just put another plug in that we are planning on hosting an investor event that Saturday evening, so hope to see many of you all in Chicago. I think you could expect what you would always expect from the first presentation of primary data. You’ll get the full data set. You’ll get the full demographic breakdown. You’ll see the Kaplan Meier curves for the first time. We know that this trial was successful. We know that we extended survival by two months, which is a meaningful extension in locally advanced pancreatic cancer.

And you’ll receive the full detail, including key secondary endpoints presented by Dr. Pikosi on stage. You know, I think, Larry, in terms of questions that we’re going to get around this trial, I think there’s always questions that I would say this is a very clean trial in a space with significant unmet need. And our engagement with the scientific committees and with the investigators has so far has been one of real excitement. There is, you know, it is extremely rare for a pancreatic cancer phase III trial to hit its endpoint, and there is a lot of interest in understanding how we can use tumor treating fields both in this locally advanced setting in combination with gemnavraxin and where we can take the research from here. So I would say it’s, you know, we’re confident that this is a community both on the academic and the commercial side that is eager to engage in a discussion on how they can extend survival for pancreatic cancer, and we look forward to sharing the data with everybody at ASCO.

Larry Biegelsen: Alright. Thanks so much.

Operator: Our next question comes from Jonathan Chang with Leerink Partners.

Ewen: This is Ewen on for Jonathan. Thanks for taking our questions, and congrats on the Pneumovia three getting accepted a late breaker at ASCO. So our question is, how should we be thinking about the potential read-through of the positive PONOVA-three results for the phase two PERNOVA four, which is in a metastatic pancreatic cancer setting, and how are you thinking about the local versus systemic control of TGPOs and the potential mechanism? Thank you.

Ashley Cordova: Thanks for the question. I’m actually gonna hand that over as how we think about local versus metastatic to Nicholas in a minute. But it is a good reminder for everybody that we do have another dataset reading out next year, the first half of next year in metastatic pancreatic cancer, which is the combination of tumor treating fields, germobraxane, and atezolizumab, in metastatic pain, which looks at the potential to, again, extend survival when we combine with an immune checkpoint inhibitor. So we’re very excited about this data set. I think the perhaps, you know, it’s always a little dangerous to do read-throughs, but perhaps the more interesting read-through is the combination of the ICI and tumor treating fields in LUNAR where we saw significant immune activation and a really profound overall survival benefit.

So we’re very excited to see this data, and I think the community is as well. But in terms of what it looks like, we’ll have to wait for the trial to read out. Anything you would add?

Nicolas Leupin: Nicole? Yeah. Thank you, Ashley. I think it’s very important to remind everyone that pancreatic cancer, especially locally advanced pancreatic cancer, has been known in clinical research as one of the biggest graveyards. I mean, all the trials so far, mainly phase two trials, have failed. So here, we’re presenting and we will present the first phase three that is positive and shows in the total package, and you’ll see that a real benefit to the patient. Now when we look at the big picture, of course, it’s also about the metastatic status of that disease and you for reminding us that PanOVA four does combine a checkpoint inhibitor in metastatic disease, and we do have some indications that we are out we have some impact outside of the treatment field. So I’m looking, you know, in a very positive way towards those results for next year, and I’m thrilled with the community to start or to open up a new modality for those patients who are really in need.

Ewen: Thank you.

Operator: Our next question comes from Jason Bednar with Piper Sandler.

Jason Bednar: Good morning. Thanks for taking the questions and all the extra color today on non-small cell lung cancer and congrats on the recent developments. Why don’t I focus maybe with the early experience in that lung cancer indication and following on Larry’s question, maybe asking it a bit of a different way. With 93 unique prescribers right now, it’s a good number. Can you talk about how you see the growth of your prescribers going forward? I hear you on the medtech-like ramp being fairly linear. But with that in mind, do you have a total target prescriber base you’re going after? What are doctors waiting to see before having greater confidence? Also in writing prescriptions versus the roughly one per quarter we saw here in the first quarter?

Frank Leonard: Jason. This is Frank. Thank you for the question. And what I’d say is that, you know, we keep going back to our message of right physician, right patient, and right time. And that is important for us because we do know, we do believe in introducing a new device-based treatment to the medical oncology profession that the first experience is really critical. And along those lines, I think the number that I’d highlight in what we released today is to look at the fact that the stage of the or the line of therapy right now has been second and third line majority. And that’s really what, you know, we’ve been focused on so that we’re getting those right patients where we’re going to have enough time to, you know, to deliver quality therapy to them, and then ensure that that physician is then, you know, interested and motivated to put the next patient on therapy.

So that’s a bit of a way of saying that looking at the targeted prescribers list, you know, we do obviously have a targeted prescribers list. We do have sort of a set number that we’re targeting overall. This sort of the pace in which that will play out is really going to be in a way that we do know that, you know, we’re not gonna go wide and have sort of physicians who have maybe put people on for salvage therapy, don’t really know us, don’t understand the therapy. That’s not something that we’ll do this year. We’re really going to be very much focused on do we have the right patients? Do we deliver the right first experience? And, you know, along with that, though, did we drive growth? Like, you know, are we driving up the number of prescribers?

And so you did see that you did see that in the sense that we moved from, you know, we didn’t give the number last quarter, but we have moved up to 60% are now new prescribers to tumor treating field. And I think that number will continue to increase as we move forward.

Jason Bednar: Okay. Thanks, Frank. Maybe I’ll one follow-up to there and then a separate question. I mean, if we think out a year or two from now, I mean, the growth in lung come more from growing the prescriber base or getting those the current prescribers that you have going deeper with those prescribers? Just trying to understand the different levers there. And then separately, what’s the status with getting long added to NCCN guidelines? How important is that? To the commercial efforts?

Frank Leonard: Yeah. Absolutely. So on the first question, you know, it will be a bit of both that we do want to get, you know, call it, better depth inside practices that we are, you know, routinely being prescribed. We will also need to grow the prescriber base. I mean, medical oncology as a profession is significantly larger than the group we deal for neuro-oncology. So there’s going to have to be growth. What I will say to highlight on the depth issue, you know, would one of the, you know, top five largest academic oncology centers in The United States has now put on six patients. The lung cancer launch. So we’re, you know, we are seeing that interest where we can get a practice to, you know, really adopt. Then on the NCCN, NCCN guidelines are absolutely the gold standard in terms of determining clinical practice for non-small cell lung cancer.

We are very focused on making sure we provided the community with enough education that Tumor Treating Fields will be reviewed at the upcoming July meeting for the NCCN.

Jason Bednar: Very helpful. Thank you.

Operator: Please press 11 on your touch-tone phone. Our next question comes from Vijay Kumar with Evercore ISI.

Vijay Kumar: Hey, guys. Thanks for taking my question. Actually, maybe on the first one, high level. The one prescriptions within the metastatic setting looks like it went up 40 since the last update you gave. How is that 40 prescriptions per quarter at this stage of the launch phase? Is that a positive number? Like, what is the right context to think about that prescription ramp?

Ashley Cordova: Yeah. I’ll just read yes. Is the short answer. So 92 prescriptions in the quarter, which is very much in line with our expectations. And I’ll just reiterate some of the points that Frank has brought up that we are focused on the right physician, the right patient at the right time in this launch trajectory to make sure that that first experience that the physician has is one that is well informed with education, which is delivered to a patient that has the best chance to productively engage with this therapy and, you know, at the right time so that we’re able to get paid for it, as we build up the reimbursement support. So, yes, is the short answer. We are pleased with the traction we’ve seen so far. And, again, we’ll look forward to providing further updates.

But everything that we see out in the field so far points to the fact that there is an unmet need here, that physicians are willing to engage in a new therapy to fill that unmet need, and that they’re excited about the potential to extend survival with Optima.

Vijay Kumar: Understood. And then on the CE Mark, in Germany, what’s the reimbursement pathway in that Germany? Is this on a case-by-case basis? Or do you have broader reimbursement? And how would revenue recognition work in Germany?

Ashley Cordova: Yeah. No. It’s a great question. So it is on a case-by-case basis at the beginning. The US and Germany are the two markets where we can launch on a case-by-case basis. I will remind everybody that we know how to do this case-by-case reimbursement, and we’re actually controlling the flow of patients such that we put patients on that we believe that we can win reimbursement for on a case-by-case appeal. That’s the right patient element of that right patient, right physician, right time mantra that we just walked through. But so in Germany, we will be following a similar path in The US. It is, you know, more attuned to the commercial side of The US market than it is the Medicare side of The US market, but we think we’ll be able to get to successful resolution of those appeals in a more standard, predictable rate over the course of the year.

Vijay Kumar: Understood. And, Christophe, maybe a couple of modeling questions for you. France was really strong. I thought France was maybe comment suggested perhaps we’re at peak-ish stage in France. Maybe talk about France opportunity and overall, when you look at the revenue picture in the quarter, any one-offs, any CMS back there? Etcetera, that we should back up.

Christoph Brackmann: Yeah. So first, I’d point to, you know, I mean, we had talked revenue growth in the quarter, and we had active patient growth of 11%. When you look at, you know, what really drives revenue, it’s Optune Geo that where we had 9% revenue growth. So, you know, basically, that gives you what were growth from price. Now France was very strong, but also when you look at the quarterly revenue projection or revenue evolution of the prior year, Q1 was the lowest quarter in the year, and that we had fairly significant growth in Q2. So we would expect that growth in France to slow down as we progress through the year. And from a big picture perspective, what we said in our last call is that for this year, we expect growth in the low mid-single-digit range, and that’s still what we would expect for the full year.

Vijay Kumar: Understood. And then maybe one last one for you on with the updated tariff picture are we looking at gross margins of low 70s? Or are we looking at mid-seventies gross margins?

Christoph Brackmann: Yeah. So as a reminder, what we said in our last call is that for 2025, we were looking at gross margins in the low seventies for 2025. And that at the time, there were two headwinds. One is the launch in lung where we treat unlabeled patients before having reimbursement. So, essentially, we have the cost before we have the revenue. And then the other headwind is the rollout of the HFE array, which is more costly than the old one at this point in the life cycle of the array. Now there’s a third headwind that came to it, which is now the tariffs. And big picture, how we think about it is that our gross margin assumption for this year has not changed. We are actually ahead of plan with our cost reduction journey on the HFE array so that we believe we can offset a large impact from the tariffs, with, you know, being ahead of cost reductions on the edge of the array. So gross margin picture for the year hasn’t changed to what we said before.

Vijay Kumar: That’s helpful. Thank you, guys.

Operator: Our next question comes from Jessica Fye with JPMorgan.

Jessica Fye: Hey, guys. Good morning. Thanks for taking my questions. I have a few. I’ll ask kind of upfront. Just like a math question. Can you walk through why you would still owe an increase of $8 million in tariffs if the pause extends through year-end? But it only goes up to $11 million if it ends after ninety days?

Christoph Brackmann: Yeah. Maybe, to the first one on tariffs. Look. I think what we also said in the call is the primary impact on the array side is from importing arrays from Israel to The US. The tariff during the pause is 10%. After that would be 7%. So it’s a step up, but it’s not a huge step up, and that basically explains why there is some difference, but not a huge difference.

Jessica Fye: Second, I know it’s early. I’m curious if you’re getting any early read in long around long patients are staying on TTF therapy and if you think that’ll track similarly to what you saw on the LUNAR trial. And then lastly, can you just touch on how enrollment is going in LUNAR two and LUNAR four and when we might expect enrollment completion there?

Frank Leonard: Hi. And with respect to the treatment duration for patients, in The US on the non-small cell lung cancer launch, I would just say first that we’re think about the time that we’ve had since launch, it’s still very short, and the first cohort of patients is just sort of crossing into that time period where we would be able to measure. But I can say that so far, it’s in line with our expectations from LUNAR.

Ashley Cordova: Yeah. And just on LUNAR two and LUNAR four, we’re still in the kind of site activation and kind of early enrollment phase of those. So I would say once we have clear line of sight to patients per site per month across our footprint, we’ll provide updated guidance there. But at the moment, I would say early days on track but not yet far enough along in enrollment to indicate having.

Jessica Fye: Great. Thank you.

Operator: Our next question comes from Emily Bodnar with H. C. Wainwright.

Emily Bodnar: Hi, good morning. Thanks for taking the questions. I guess for the first one, for Germany with the long launch, if you can kind of discuss how you think about ramp up there relative to your current ramp up in The US. And also, in terms of the initial $1.5 million that was recognized, I believe $700,000 was for lung. How should we think about revenues in The US for 2025 since it seems like you’re able to get reimbursement already? Thanks.

Frank Leonard: Hi. I’ll start with addressing the launch in Germany. And I’ll just start by saying, first, that we are very pleased with the label that we’ve secured under the CE mark. We once again, we have access to this broad population of patients who have had a platinum failure in the first line. And just as in The United States, these patients in Germany have a high unmet need that we can address with high clinical value. So we’re starting from the fact that we think we have a big population and a good label. We also have a strong team in Germany that has been able to promote to the NPM indication. And I think if as you look at the numbers, they’re relatively small, but you can see that there was a focus on NPM in the fourth quarter and the first quarter.

So the team is in the field, knows the doctors, ready to go, and I think, you know, what I can say is we’re not gonna provide a sort of specific direction of targets for the year or the quarter, but I can say Ashley said, which is Germany generally mirrors our US business in terms of both how medicine is practiced, how the reimbursement system works, and so our launch strategy will, you know, will be largely the same.

Christoph Brackmann: Yeah. And on the other question, revenue for NACLC, I mean, point one is it it’s gonna be reflective of the cash collections in the period. Right? And then quarter over quarter, it will reflect the ramp on the patient side. But this is a good sign that we’ve seen revenue come in the drawer. Think already, I think what we’re seeing is we’re able to get these bills out the door. We’re able to get insurance approvals, and, actually, we’re able to get fully through that cash collection cycle within, you know, a quarter, which is certainly promising.

Emily Bodnar: Alright. Thank you.

Operator: That concludes today’s question and answer session. Like to turn the call back to Bill Doyle for closing remarks.

Bill Doyle: So once again, I’d like to thank everyone on the call for their interest in NovoCure Limited. I’m very pleased that after a very strong 2024, we’ve been able to continue that momentum into Q1 and achieve some very important milestones so far. We’re delighted with the CE Mark for non-small cell lung cancer in Europe. We’re looking forward to progress in Japan and adding that market to our trio of non-small cell lung cancer markets. We couldn’t be more pleased with our positioning at ASCO for the presentation of the Panova dataset. As has been mentioned several times, the so far, the only phase three trial to be successful in the locally advanced pancreatic cancer population. And then on the regulatory front, we’re pleased with the progress that we’ve made with both Metis and Canova.

And we anticipate the completion of those filings and being potentially launch-ready in 2026. So it is exciting at NovoCure Limited. We’re well into the pivot that we’ve described as we take the company from our solid base in GBM into the next chapter, where we’re an international multi-indication oncology company. And, again, thank you for your continued interest in NovoCure Limited.

Operator: This concludes today’s conference call. Thank you for participating. You may now disconnect.