NovoCure - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 delivered a clean top-line and profitability beat versus consensus: revenue $155.0M vs $147.0M consensus and EPS loss $0.31 vs $0.46 consensus; adjusted EBITDA improved to $(5.0)M vs $(45.1)M consensus. Management highlighted momentum across GBM and early NSCLC adoption, with 4,268 active patients globally.*
• Gross margin of 75% declined YoY on HFE array rollout and treating NSCLC patients ahead of broad reimbursement; 2025 gross margin assumption remains “low 70s” despite new tariff headwinds (potential $8–$11M duties) offset by cost reductions on HFE arrays.
• Guidance cadence maintained: 2025 revenue growth expected low-to-mid-single digits; steady expense discipline with modest G&A increases and NSCLC launch investments (U.S. + Germany case-by-case reimbursement).
• Near-term catalysts: CE Mark for Optune Lua in metastatic NSCLC (Germany launch imminent), July NCCN guideline review, and late-breaking PANOVA-3 presentation at ASCO with an investor event, plus ongoing PMA workstreams (METIS, PANOVA-3).

What Went Well and What Went Wrong

What Went Well

• NSCLC momentum: 92 prescriptions in Q1, 62 active NSCLC patients by quarter-end, with ~50/50 ICI vs docetaxel use and 93 unique prescribers (60% new to TTFields) showing breadth beyond neuro-oncology.
• Regional strength and GBM base: Record 4,162 Optune Gio active patients; double-digit active-patient growth in France (+46%), Japan (+17%), Germany (+10%), U.S. (+4%) YoY.
• Regulatory wins and visibility: CE Mark for Optune Lua in mNSCLC; PANOVA-3 late-breaking oral presentation at ASCO, positioning TTFields with positive Phase 3 data in a high-need indication.

What Went Wrong

• Margin pressure persisted: Gross margin fell to 75% (vs 76% YoY), impacted by HFE array rollout and treating NSCLC patients prior to broad reimbursement.
• Tariff uncertainty introduced incremental COGS risk: U.S. tariff pause at 10% could still drive up to $8M duties in 2025, or up to $11M if prior rates resume; management working to mitigate with supply chain optimization.
• Loss-making profile continues: Net loss of $34.3M and adjusted EBITDA of $(5.0)M, though both improved vs expectations; revenue from NSCLC recognized on cash collections until a billing/collection track record is established.*

Transcript

Operator (participant)

Good day, and thank you for standing by. Welcome to the Novocure Q1 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one 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 (VP of Investor Relations)

Good morning, and thank you for joining us to review Novocure's Q1 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'll 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 non-cash 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 in our Form 10Q 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 (Executive Chairman)

Thank you, Ingrid, and good morning. For 25 years, our mission at Novocure 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 as we move from a single indication treating patients with GBM to becoming a multi-indication oncology company. With five successful phase 3 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. Before we dive into the quarterly updates, I would like to highlight two items of breaking news.

On Tuesday morning, we announced that Optune Lua 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 III, our successful Phase III 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 III trial will be presented on Saturday, May 31st, by lead investigator Dr. Vincent Picozzi of the Virginia Mason Medical Center as part of the gastrointestinal cancer oral abstracts clinical session. That evening at 7:00 P.M.

Central Time, we plan to host an investor event with a live webcast to dive into the results with Dr. Picozzi 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 13% and a growing global incidence. Panova III is the first and only Phase III trial to demonstrate a meaningful survival benefit in locally advanced pancreatic cancer. Presentation of the Panova III 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 III results with clinicians and investors next month. I'll now turn the call over to Ashley to provide further updates on Q1.

Ashley Cordova (CEO)

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 Optune Lua and our newest indication, metastatic non-small cell lung cancer, and immediately initiated our U.S. launch. After a strong start, we remain highly encouraged by the early commercial indicators. In the Q1, we received 92 non-small cell lung cancer prescriptions and ended the period with 62 patients on therapy. We also had 44 mesothelioma patients on therapy for a total of 106 Optune Lua active patients.

These early results in non-small cell lung cancer reflect our focused and disciplined launch strategy centered on reaching the right physicians for the right patients at the right time. Our initial efforts have concentrated on engaging physicians most likely to adopt Optune Lua, 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 60% of these prescribers new to Tumor Treating Fields therapy. Many come from institutions that have never prescribed Optune Gio for 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 Optune Lua 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 30% 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 in 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 expressors 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 Optune Lua. Combined, we believe these groups represent approximately 30,000 eligible patients in the U.S. annually. Encouragingly, our early adoption includes patients from all three populations. Of the 62 non-small cell lung cancer active patients on therapy at quarter end, there was roughly a 50/50 split between concomitant ICI and docetaxel use. As of March 31, over 90% of the patients who were prescribed Optune Lua 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 Optune Lua at first sign of progression, and minimizing use as a salvage therapy. Our positioning has been successful thus far. Through the end of Q1, approximately 50% of the prescriptions received were for Optune Lua in second-line use, with another 25% prescribed for third-line use. As Bill mentioned, earlier this week, we were thrilled to announce CE mark approval for the treatment of metastatic non-small cell lung cancer in European markets. Our team is launch ready.

As a reminder, we have an Optune Lua sales force in place in Germany that has been detailing Optune Lua 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 non-small cell lung cancer in the coming weeks. This is an important milestone, and we are excited to add a second market to drive Optune Lua 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 business, Q1 performance was strong with a record 4,162 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 elements 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 U.S., representing a significant portion of the 2,100-plus U.S. 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, they also set the stage for scalable high-touch services as we enter a multi-indication future. Turning to regulatory catalysts, PMA submissions for both Metis and Panova III 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 III 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 cancers, maximize 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 III Keynote D58 and Lunar II trials and our Phase II Lunar IV trial.

Our Phase III Trident trial and our Phase II 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. After years 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 Christoph to discuss our financial performance in the quarter.

Christoph Brackmann (CFO)

Thank you, Ashley. 2025 is off to a strong start. In the Q1, we generated $155 million of net revenue, an increase of 12% from the Q1 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 prior year by 46% in France, 17% in Japan, 10% in Germany, and 4% in the U.S. We collected $1.5 million from Optune Lua claims in the quarter, which was split roughly 50/50 between MPM and NSCLC. It's encouraging to see the initial results of our NSCLC reimbursement efforts in the form of approvals and positive outcomes from appeals. As a reminder, according to U.S. GAAP, we recognize revenue by applying our estimated future collection rate at time of billing.

Since NSCLC is a new indication, we will need to build a collection track record to support a collection rate estimate to enable revenue recognition 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 NSCLC launch, where we are treating on-label 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 U.S. from Israel, with lesser potential impacts from imports from Mexico and Europe. If tariffs return to the increased rates announced before the current 90-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 ramped down spend on some large Phase III trials and ramped up spend 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 U.S. 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 Q1 of 2024. This increase was primarily due to a one-time $2.3 million expense to retired 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 as we prepare for multiple potential new product launches in the coming years. While investing for growth, we are determined to keep our operating 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 Q1 in role. This is an incredibly exciting time for Novocure as we pivot from a single indication to a multi-indication company. Tumor Treating Fields therapy has been clinically de-risked in several important cancer indications through large randomized phase 3 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 seeing many of you at ASCO.

We will now turn to our operator for your questions.

Operator (participant)

As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from Larry Biegelsen with Wells Fargo.

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

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 III. Just starting with non-small cell lung cancer, we're trying to benchmark the launch to newly diagnosed GBM just as obviously a benchmark. The scripts look like they're about 25% 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? 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? I had one follow-up.

Ashley Cordova (CEO)

Yeah. Sure, Larry, this is Ashley. Good to hear from you. I'll actually add Frank to provide some color on the launch after the answer. The short answer is it's 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 a general medical oncologist. This is an oncology community that now knows Tumor Treating Fields because we're not launching in our first indication. It's just a different patient segment. 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 built, and to say that we have the sales force in place that we need to be able to detail the high decile physicians that are prescribing a non-small cell lung cancer.

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

Frank Leonard (President)

Yeah. Hi, Larry. I'll just say that 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. We're seeing in the numbers that we do have 90% of the patients who have been previously treated with immune checkpoint inhibitors. That, again, gives us real confidence that there's a big population out there to go and pursue. 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 Fields. We were able to have Optune Lua added to the drop-down ordering menu in the electronic medical record of one of the largest private practices in the U.S.

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 (Senior Medical Device Equity Research Analyst)

That's very helpful. Switching gears to Panova III, Ashley, maybe 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, % of patients who become surgically operable? How are you going to address pushback from academic physicians that you used gemcitabine in the control arm and not FOLFIRINOX in the control arm? Thanks.

Ashley Cordova (CEO)

Great. I will just remind everybody that we were very pleased to have our late-breaking abstract accepted for oral presentation on Saturday afternoon at ASCO. This is really prime podium time for our Panova III dataset presentation. 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 dataset. 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. You'll just see the full detail, including key secondary endpoints presented by Dr. Picozzi on stage.

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. Our engagement with the scientific committees and with the investigators so far has been one of real excitement. It is extremely rare for a pancreatic cancer Phase III trial to hit its endpoint. There is a lot of interest in understanding how we can use Tumor Treating Fields both in this locally advanced setting in combination with gemabraxine and where we can take the research from here. I would say 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.

We look forward to sharing the data with everybody at ASCO.

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

All right. Thanks so much.

Operator (participant)

Our next question comes from Jonathan Chang with Leerink Partners.

Jonathan Chang (Senior Managing Director)

This is Ewen Ong for Jonathan. Thanks for taking our questions. Congrats on the Panova III getting accepted as a late-breaker at ASCO. Our question is, how should we be thinking about the potential read-through of the positive Panova III results for the Phase II Panova IV, which is in the metastatic pancreatic cancer setting? How are you thinking about the local versus systemic control of TTFields and the potential mechanism? Thank you.

Ashley Cordova (CEO)

Thanks for the question. I'm actually going to hand that over as how we think about local versus metastatic to Nicolas in a minute. 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, gemcitabine, and atezolizumab in metastatic pancreatic, which looks at the potential to, again, extend survival when we combine with an immune checkpoint inhibitor. We are very excited about this dataset. I think perhaps 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. We are very excited to see this data, and I think the community is as well.

In terms of what it looks like, we'll have to wait for the trial to read out. Anything you would add?

Christoph Brackmann (CFO)

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 II trials, have failed. Here we're presenting, and we will present the first Phase III that is positive and shows in the full packaging, 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. Thank you for reminding us that Panova IV does combine a checkpoint inhibitor in metastatic disease. We do have some indications that we have some impact outside of the treatment field. I'm looking in a very positive way towards those results for next year.

I'm thrilled with the community to start or to open up a new modality for those patients who are really in need.

Jonathan Chang (Senior Managing Director)

Thank you.

Operator (participant)

Our next question comes from Jason Bednar with Piper Sandler.

Jason Bednar (Senior Research Analyst)

Good morning. Thanks for taking the questions and all the extra color today on non-small cell lung cancer. 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 in 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 med tech like ramp being fairly linear. 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 Q1?

Frank Leonard (President)

Hi, Jason. This is Frank. Thank you for the question. What I'd say is that we keep going back to our message of right physician, right patient, and right time. That is important for us because we do believe in introducing a new device-based treatment to the medical oncology profession that the first experience is really critical. 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 or the line of therapy right now has been second and third line majority. That's really what we've been focused on so that we're getting those right patients where we're going to have enough time to deliver quality therapy to them and then ensure that that physician is then interested and motivated to put the next patient on therapy.

That's a bit of a way of saying that looking at the targeted prescribers list, we do obviously have a targeted prescribers list. We do have sort of a set number that we're targeting overall. The pace at which that will play out is really going to be in a way that we do know that we're not going to 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? Did we deliver the right first experience? Along with that, though, did we drive growth? Are we driving up the number of prescribers? You did see that.

You did see that in the sense that we moved from we didn't give the number last quarter, but we have moved up to 60% are now new prescribers to Tumor Treating Fields. I think that number will continue to increase as we move forward.

Jason Bednar (Senior Research Analyst)

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

Frank Leonard (President)

Yeah, absolutely. On the first question, it will be a mix of both that we do want to get, call it better depth inside practices that we are 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 with for neurooncology. There is going to have to be growth. What I will say to highlight on the depth issue, one of the top five largest academic oncology centers in the United States has now put on six patients for the lung cancer launch. We are seeing that interest where we can get a practice to really adopt. 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've provided the community with enough education that Tumor Treating Fields will be reviewed at the upcoming July meeting for the NCCN.

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

Very helpful. Thank you.

Operator (participant)

As a reminder, if you'd like to ask a question at this time, please press star 11 on your touch-tone phone. Our next question comes from Vijay Kumar with Evercore ISI.

Vijay Kumar (Senior Managing Director)

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

Ashley Cordova (CEO)

Yeah. I'll just read. Yes is the short answer. Ninety-two prescriptions in the quarter, which is very much in line with our expectations. 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 at the right time so that we're able to get paid for it as we build up the reimbursement support. Yes is the short answer. We are pleased with the traction we've seen so far. Again, we'll look forward to providing further updates.

Everything that we see out in 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 optimal life.

Vijay Kumar (Senior Managing Director)

Understood. On the CE mark in Germany, what's the reimbursement pathway in Germany? Is this on a case-by-case basis or do you have broader reimbursement? How would revenue recognition work in Germany?

Ashley Cordova (CEO)

Yeah. No, it's a great question. It is on a case-by-case at the beginning. The U.S. 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. In Germany, we will be following a similar path. In the U.S., it is more attuned to the commercial side of the U.S. market than it is the Medicare side of the U.S. market.

We think we'll be able to get to successful resolution of those appeals in a more standard, predictable reimbursement rate over the course of the year.

Vijay Kumar (Senior Managing Director)

Understood. Christoph, maybe a couple of modeling questions for you. France was really strong. I thought France was maybe, common suggested, perhaps we're at peakish 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 paying, etc., that we should back out?

Christoph Brackmann (CFO)

Yeah. First, I'd point to, I mean, we had 12% revenue growth in the quarter, and we had active patient growth of 11%. When you look at what really drives revenue, it's Optune Gio where we had 9% revenue growth. Basically, that gives you what we're growth from price. Now, France was very strong. Also, when you look at the quarterly revenue projection or revenue evolution of prior year, Q1 was the lowest quarter in prior year. We had fairly significant growth in Q2. We would expect the growth in France to slow down as we progress through the year. From a big picture perspective, what we said in our last call is that for this year, we expect growth in the low to mid single-digit range. That's still what we would expect for the full year.

Vijay Kumar (Senior Managing Director)

Understood. Maybe one last one for you, with the updated tariff picture. Are we looking at gross margins of low 70s or are we looking at mid 70s gross margins?

Christoph Brackmann (CFO)

Yeah. As a reminder, what we said in our last call is that for 2025, we were looking at gross margins in the low 70% for 2025. At the time, there were two headwinds. One is the launch in lung where we treat unlabeled patients before having reimbursement. Essentially, we have the cost before we have the revenue. 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 is a third headwind that came to it, which is now the tariffs. 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 being ahead of cost reductions on the HFE array. The gross margin picture for the year has not changed to what we said before.

Vijay Kumar (Senior Managing Director)

That's helpful. Thank you, guys.

Operator (participant)

Our next question comes from Jessica Fye with J.P. Morgan.

Jessica Fye (Managing Director)

Hey, guys. Good morning. Thanks for taking my questions. I have a few I'll just 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 90 days? Second, I know it's early. I'm curious if you're getting any early read in lung around how long patients are staying on TTF therapy and if you think that'll track similarly to what you saw in the Lunar trial. And then lastly, can you just touch on how enrollment is going in Lunar II and Lunar IV and when we might expect enrollment completion there? Thank you.

Larry Biegelsen (Senior Medical Device Equity Research Analyst)

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 U.S. The tariff during the pause is 10%. After that, it would be 7%. It is a step up, but it is not a huge step up. That basically explains why there is some difference, but not a huge difference.

Frank Leonard (President)

Hi. With respect to the treatment duration for patients in the U.S. on the non-small cell lung cancer launch, I would just say first that if you think about the time that we've had since launch, it's still very short. The first cohort of patients is just sort of crossing into that time period where we would be able to measure. I can say that so far, it's in line with our expectations from Lunar.

Ashley Cordova (CEO)

Yeah. Just on Lunar II and Lunar IV, we're still in the kind of site activation and kind of early enrollment phase of those. 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. At the moment, I would say early days, on track, but not yet far enough along in enrollment to indicate timing.

Christoph Brackmann (CFO)

Great. Thank you.

Operator (participant)

Our next question comes from Emily Bodnar with HC Wainwright.

Emily Bodnar (Biotech Equity Research Analyst)

Hi. Good morning. Thanks for taking the questions. I guess for the first one, for Germany with the lung launch, if you can kind of discuss how you think about ramp-up there relative to your current ramp-up in the U.S. Also, in terms of the initial $1.5 million that was recognized, I believe $0.7 million was for lung. How should we think about revenues in the U.S. for 2025 since it seems like you're able to get some reimbursement already? Thanks.

Frank Leonard (President)

Hi. I'll start with addressing the launch in Germany. I'll just start by saying first that we are very pleased with the label that we've secured under the CE mark. Once again, we have access to this broad population of patients who have had a platinum failure in the first line. Just as in the United States, these patients in Germany have a high unmet need that we can address with high clinical value. 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 MPM indication. I think as you look at the numbers, they're relatively small, but you can see that there was a focus on MPM in the Q4 and the Q1.

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

Christoph Brackmann (CFO)

Yeah. On the other question, revenue for NSCLC, I mean, point one is it's going to be reflective of the cash collections in the period, right? Quarter over quarter, it will reflect the ramp on the patient side.

Ashley Cordova (CEO)

It is a good sign that we've seen revenue come in the door, I 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. Actually, we're able to get fully through that cash collection cycle within a quarter, which is certainly promising.

Emily Bodnar (Biotech Equity Research Analyst)

Great. Thank you.

Operator (participant)

That concludes today's question and answer session. I'd like to turn the call back to Bill Doyle for closing remarks.

Bill Doyle (Executive Chairman)

Once again, I'd like to thank everyone on the call for their interest in Novocure. 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, so far the only phase 3 trial to be successful in the locally advanced pancreatic cancer population. On the regulatory front, we're pleased with the progress that we've made with both METIS and PANOVA. We anticipate the completion of those filings and being potentially launch ready in 2026.

It is exciting at Novocure. 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. Again, thank you for your continued interest in Novocure.

Operator (participant)

This concludes today's conference call. Thank you for participating. You may now disconnect.