NovoCure - Earnings Call - Q4 2024

Executive Summary

• Q4 2024 net revenues were $161.3M (+21% YoY), gross margin 79%, and adjusted EBITDA $2.6M; GAAP net loss was $65.9M ($0.61/share) driven by higher G&A tied to lung approval stock comp.
• GBM remains the core: 1,520 Optune Gio prescriptions and 4,077 active GBM patients; total TTFields active patients reached 4,126 globally.
• NSCLC launch underway: 52 Optune Lua prescriptions and 20 active NSCLC patients since Oct 15 FDA approval; management expects commercial coverage wins in 2025 and “meaningful” lung revenue in 2026.
• Guidance signals: 2025 revenue growth to track Optune Gio active patient growth (low mid-single digit), gross margin to the low-70s near term (HFE arrays cost, at‑risk lung launch), OpEx up in S&M for launch; R&D roughly stable.
• Stock reaction catalysts: regulatory submissions for METIS (brain metastases) and PANOVA‑3 (pancreatic), coverage milestones for NSCLC, and HFE array rollout; all reinforce the evolution to a multi‑indication platform.

What Went Well and What Went Wrong

What Went Well

• Multi‑indication pivot delivered: “2025 is a defining year… propelled by positive Phase 3 data in three indications – one FDA‑approved and two advancing toward regulatory submission” — CEO Ashley Cordova.
• Strong operational execution: Q4 revenue +21% YoY, adjusted EBITDA turned positive, and improved U.S. approval rates increased prior‑period collections ($8.3M in Q4; $22.3M FY) enhancing net revenue per patient.
• Clinical and regulatory momentum: Optune Lua FDA approval for metastatic NSCLC; PANOVA‑3 met OS endpoint (mOS 16.2 vs 14.2 months; HR=0.819, p=0.039); METIS success in brain mets; Breakthrough Device designations accelerate filings.

What Went Wrong

• Profitability headwind: Q4 net loss widened to $65.9M; G&A up 84% YoY on $36.1M one‑time stock‑based comp tied to NSCLC approval; expect near‑term gross margin pressure from HFE arrays and lung launch.
• China softer in Q4: revenue from Zai Lab fell to $2.0M (timing; royalty amortization roll‑off), establishing a lower baseline versus Q3 ($4.6M) and Q2 ($5.8M).
• Estimates context unavailable: S&P Global consensus estimates could not be retrieved; comparison to Street is limited; investors should adjust models for removal of prior‑period claims from baseline and lower near‑term margin outlook [GetEstimates unavailable – Values from S&P Global not available].

Transcript

Operator (participant)

Good day, and thank you for standing by. Welcome to the Novocure Fourth Quarter 2024 earnings conference 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 will 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 speaker today, Ingrid Goldberg. Please go ahead.

Ingrid Goldberg (Head of Investor Relations)

Good morning, and thank you for joining us to review Novocure's fourth quarter and full year 2024 performance. I am on the phone this morning with our Executive Chairman, Bill Doyle, CEO, Ashley Cordova, and our CFO, Christoph Brackmann. Other members of our Executive 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 may 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 10-K 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. Good morning, everyone. For 25 years, our mission at Novocure has been to extend survival for patients with some of the most aggressive forms of cancer by developing and commercializing our novel therapy, Tumor Treating Fields. Prior to 2025, our commercial efforts focused largely on the treatment of glioblastoma. After achieving key milestones in 2024, FDA approval for the treatment of non-small cell lung cancer and successful Phase III readouts in pancreatic cancer and brain mets from non-small cell lung cancer, 2025 is set to be a defining year for Novocure as we move beyond a single indication to become a multi-indication oncology company. Our focus now is on execution and bringing TTFields therapy to many more patients in need.

Entering 2024, we define three clear objectives for our organization: grow our core GBM business, launch our non-small cell lung cancer indication, and deliver on the promise of our clinical pipeline. I am proud to report we achieved all of these objectives. In 2024, we generated $605 million in net revenue, growing our global active patient count to over 4,000. We received FDA PMA approval to treat second-line non-small cell lung cancer with a broad label and immediately began treating patients in the U.S. We had two additional positive readouts from large randomized Phase III clinical trials: METIS and brain mets from non-small cell lung cancer and PANOVA-3 in locally advanced pancreatic cancer. 2024 was a year of strong achievement at Novocure and has set the stage for a pivotal year in 2025.

In the 25 years since our founding, we have grown to a team of nearly 1,500 people, treated over 35,000 GBM patients, and are now poised to reach tens of thousands more with other difficult-to-treat cancers in the years to come. Our organizational evolution has included preparing to scale our operations to effectively reach these patients while continuing to expand our approved indications. Last year, we announced that Ashley Cordova, our CFO, would succeed our founding CEO, Asaf Danziger, after his retirement in December, and that Christoph Brackmann would be joining our team as our new CFO. 2025 marks the beginning of a new chapter for Novocure as we build upon our strong foundation treating patients with GBM to begin to realize the full potential of the tumor-treating fields platform.

I am pleased to turn the call to Ashley to provide more detail on our achievements in 2024 and our plans for 2025. Christoph will then review our fourth quarter and full year financial performance, after which we will take your questions. Ashley?

Ashley Cordova (CEO)

Thank you, Bill. I am honored to step into the role of Chief Executive Officer at this pivotal moment in Novocure's history. Our mission has never felt more urgent as we expand our reach to patients facing some of the most challenging solid tumors with significant unmet need. To provide more detail on Bill's opening remarks, our first objective in 2024 was to grow our GBM business. GBM remains the foundation of our company, providing financial strength to invest in our pipeline and execute multiple launches. In 2024, we grew active patients by 10%, surpassing 4,000 active patients on therapy for the first time. Our growth was driven by strong performance in multiple markets, including France, now our third-largest market, and Germany and Japan. Improved U.S. approval rates contributed to 2024 top-line growth as higher U.S. net pricing complemented the increase in global active patients.

Our second goal in 2024 was to launch our newest indication, Optune Lua, in second-line non-small cell lung cancer. Entering the year, we submitted a PMA application to the FDA based on the LUNAR Phase III clinical trial data and began the process of building a thoracic sales force in anticipation of FDA approval. On October 15, we received FDA approval with a broad label, including both docetaxel and physician's choice of immune checkpoint inhibitor as concomitant therapy options. Our Optune Lua sales team was immediately in the field, and between approval and year-end, we received 52 prescriptions, and we finished the year with 20 active patients on therapy. We are pleased with these initial results, and the early feedback from patients and physicians is promising.

Patients are eager to access a new, unique therapy in non-small cell lung cancer, and we are seeing interest from thoracic oncologists, medical oncologists, and radiation oncologists in both concomitant chemotherapy and immunotherapy options. While early demand is promising, we remind investors that we are currently in the process of securing reimbursement, and these negotiations take time. We expect payer coverage milestones in 2025, with material revenue ramping in 2026 as coverage expands. Our final 2024 objective was to deliver on the promise of our clinical pipeline in indications with extremely high unmet need. In March, we announced successful top-line results from our Phase III METIS trial investigating Tumor Treating Fields therapy for the treatment of brain metastases from non-small cell lung cancer following stereotactic radiosurgery. METIS met its primary endpoint.

Patients treated with Tumor Treating Fields therapy exhibited 21.9 months median time to intracranial progression compared to 11.3 months for patients treated with supportive care. In December, we announced successful top-line results from our Phase III PANOVA-3 trial investigating Tumor Treating Fields therapy together with gemcitabine and nab-paclitaxel for the treatment of unresectable locally advanced pancreatic cancer. PANOVA-3 also met its primary endpoint as patients randomized to receive Tumor Treating Fields therapy demonstrated median overall survival of 16.2 months compared to 14.2 months in the control arm. PANOVA-3 is the first and only Phase III trial to demonstrate a statistically significant survival benefit in this notoriously difficult-to-treat patient population. Early reactions from key pancreatic physicians have been very supportive, and we look forward to presenting the full data set at a medical conference later this year.

METIS and PANOVA-3 represent major opportunities to expand our market reach as each serves patient populations with extremely high unmet need. Brain metastases from non-small cell lung cancer and locally advanced pancreatic cancer, together with our recent lung cancer launch, have the potential to increase our eligible patient population to 7X our GBM opportunity. Beyond these near-term catalysts, we continue to invest in our pipeline in GBM, lung, and pancreatic cancers. With ongoing trials like TRIDENT, LUNAR-2, KEYNOTE-D58, and PANOVA-4, we see additional label expansion potential over the next few years. To touch on these trials quickly, our Phase III TRIDENT trial in GBM is studying the addition of Tumor Treating Fields therapy to chemoradiation rather than starting after chemoradiation, potentially increasing the duration and efficacy benefit of Tumor Treating Fields. TRIDENT is fully enrolled, and we expect data in the first half of 2026.

Our other pipeline trials are studying the concomitant use of tumor-treating fields therapy and immune checkpoint inhibitors, a regimen that showed immense promise in the LUNAR data set. These trials include our Phase III LUNAR-2, our Phase II LUNAR-4, our Phase III KEYNOTE-D58, and our Phase II PANOVA-4 trials. The first three trials are open and enrolling. PANOVA-4 is fully enrolled, and we expect data in the first half of 2026. These trials represent the next wave of innovation in Novocure's clinical pipeline, with the potential to significantly expand the use of tumor-treating fields therapy in the cancers where we have already established clinical benefit. Beyond the progress made advancing our clinical pipeline, we achieved key milestones in our product development program with the approval of our HFE arrays in the U.S. and Japan.

The HFE arrays are thinner, lighter, and more flexible than our legacy arrays. We are rolling out the HFE arrays in all major markets, and feedback has been very encouraging. We believe the rollout of our next-generation HFE array is an important step in improving patient usage, reducing barriers to adoption, and ultimately expanding the market for Tumor Treating Fields therapy. As we reflect on the progress achieved in 2024, the Novocure story has substantially evolved. With the binary clinical events of prior years behind us, we are now focused on execution. 2025 is off to a strong start, and we expect to reach multiple important milestones this year. In lung cancer, we will continue to provide insights into the progress of our Optune Lua launch. We will pursue clinical guidelines and reimbursement in the U.S. and regulatory approvals in Europe and Japan.

In brain mets, we expect to publish the METIS trial results and are engaged with the FDA in pre-submission discussion in anticipation of submitting a PMA application later this year. In pancreatic cancer, we expect to present the PANOVA data at an upcoming medical conference, followed by publication in a peer-reviewed journal, and again, we are engaged with the FDA in pre-submission discussion in anticipation of submitting a PMA application later this year. With FDA breakthrough designation for both brain mets and pancreatic cancer, we have the potential for launches in both indications in 2026. 2025 marks the beginning of a new era in Novocure's journey as we evolve from one indication in GBM to a multi-indication platform therapy company. The vision is clear. We are working to extend survival for as many patients as possible as we build on an incredibly strong foundation.

With that, I would like to turn the call over to our newest executive colleague, Christoph Brackmann.

Christoph Brackmann (CFO)

Thank you, Ashley, and thank you all for joining us this morning. This is an incredibly exciting time for Novocure as we pivot from a single indication to a multi-indication company, and I feel very privileged to be joining Novocure at this unique time. 2024 was a year of successful execution and growth. We generated revenues of $161 million in the fourth quarter of 2024, an increase of 21% compared to the same period in 2023, and $605 million for the full year, an increase of 19% year-over-year. This growth was primarily driven by our continued launch success in France, strong active patient growth in Germany and Japan, and significantly improved approval rates in the U.S., which are now reflected in our revenue baseline. Improved approval rates in the U.S. resulted in $8.3 million of revenue from prior period claims during the quarter and $22.3 million for the full year.

2025 revenue growth is expected to closely reflect growth in Optune Gio active patients. As the GBM business reaches maturity, we expect to continue to grow at a low, mid-single-digit rate this year. On the long side, as Ashley explained earlier, our focus this year is on educating physicians, generating demand, and negotiating payer coverage. We anticipate meaningful revenue contributions starting in 2026 as coverage expands. Looking further ahead, we believe we have a clear path to address a patient population in multiple indications, which taken together is seven times larger than our GBM opportunity, and we are very focused on execution to reach these patients. Our gross margin in the fourth quarter was 79% and 77% for the full year 2024, compared to 75% in 2023.

The improvement in gross margin is due to the increase in net revenue per patient, primarily attributed to our improved approval rates in the U.S. This year, we expect the global launch of the HFE arrays and the non-small cell lung cancer launch to be headwinds to gross margin. Regarding the ongoing global trade discussions, our global manufacturing supply chain networks allow for flexibility and capacity optimization. Based on current estimates, we do not foresee a material impact to margins in the short term, but we will continue to monitor this fluid situation closely. Sales and marketing expenses in the fourth quarter were $67 million and $239 million for the full year, reflecting increases of 14% and 5% respectively compared to prior year periods.

G&A expenses in the fourth quarter were $72 million and $190 million for the full year, reflecting increases of 84% and 16% respectively, primarily driven by stock-based compensation expenses related to the lung approval. Excluding stock-based compensation, G&A expenses for the full year were $10 million lower than 2023, driven by our 2023 restructuring efforts. Looking ahead, as our thoracic sales forces in the U.S. and Germany are now fully staffed, we would expect some incremental expense, primarily for marketing and preparation for launch in additional countries. Research and development costs for the fourth quarter were $51 million, bringing the annual total to $210 million, decreases of 6% from both prior periods. We anticipate our R&D expenses to be roughly stable in 2025. Net loss for the fourth quarter was $66 million, or $0.61 per share. Net loss for the year was $169 million, or $1.56 per share.

Adjusted EBITDA for the fourth quarter was $3 million, an increase of $34 million from Q4 2023, and full-year adjusted EBITDA was $1 million, an increase of $107 million compared to last year. This increase in adjusted EBITDA was driven by growth in net revenue, as well as disciplined management of operating expenses. While we continue to invest in growth opportunities, profitability remains an important goal at Novocure and something we are actively driving towards. We anticipate generating positive adjusted EBITDA on a sustainable basis once we generate more material revenue from new indications. Cash and cash equivalents were $960 million as of December 31, 2024. As a reminder, we have a $561 million convertible note outstanding, which comes due in the fourth quarter.

We believe the combination of cash on hand and funds available via our credit facility provide us with the necessary capital to pay the convertible note in full and fund operations for the foreseeable future. I would like to turn the call now back to Ashley for closing comments.

Ashley Cordova (CEO)

Thank you, Christoph. To close, our vision is clear. We are striving to extend survival in some of the most aggressive forms of cancer. With the binary clinical events of prior years behind us, we are now focused on execution. This year marks the beginning of a new era in Novocure's journey as we evolve from a single GBM indication into a multi-indication platform company. And if we look beyond the next two years, we are only scratching the surface of what Tumor Treating Fields therapy could afford patients. I'll now turn the call back to the operator for questions.

Operator (participant)

Thank you. 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 the line of Jonathan Chang with Leerink Partners. Your line is now open.

Jonathan Chang (Senior Managing Director and Senior Research Analyst)

Hi guys. Thanks for taking my questions. Can you provide any more granularity on when and where we might see the PANOVA full data presentation and can provide any color on what we could learn when we get the full presentation versus the top-line disclosure at the end of last year? Thank you.

Ashley Cordova (CEO)

Jonathan, this is Ashley. I'll start, and then Nicolas can jump in with more granularity. But the short answer is, unfortunately, we can't provide it any sooner than what we've shared. As soon as we can get this PANOVA-3 data out, we will. We're targeting all of the obvious conferences in the spring, but we'll be able to share more once we have confirmed acceptance.

Nicolas Leupin (CMO)

Yeah, thank you, Ashley. This is Nicolas. Thank you, Jonathan, for that question. I don't have much to add to this. I mean, these are really important data, and we are thrilled to present them soon.

Jonathan Chang (Senior Managing Director and Senior Research Analyst)

Got it. Thanks.

Operator (participant)

Thank you. Our next question comes from the line of Jason Bednar with Piper Sandler. Your line is now open.

Jason Bednar (Managing Director and Senior Research Analyst)

Hello. Good morning. I wanted to start on the lung side. A lot of investor questions just around the trajectory of the lung launch after what was a pretty good start. I think a lot of us can agree in the fourth quarter. And I don't expect you to guide scripts or patients, but do you have targets on these metrics you'd consider a success when we look at this year or next? And also, what does the trajectory look like in the U.S. here as we think about the kind of cadence of 2025? And then if at all, and sorry to layer on a few here, but can you talk about just the early experience of patient compliance, doctors being repeat customers, the actual expansion of your doctor customer base and lung? Anything there would be helpful.

Frank Leonard (President)

Hi, Jason. This is Frank. Thank you for the questions. I'll start off in terms of talking about our objectives for the launch and how that maps out to volume growth. First, what we've said before stays true, that we're really focused on getting the right physician with the right patient at the right time as our initial launch objective. And that's to take the learnings from GBM. We want to ensure a really strong positive first experience for the physician and the patient, which then builds confidence for that next prescription and an expansion within that physician's practice. It also ensures that we have, what I would say, are really good cases to argue with the insurance companies as we move towards coverage.

That's really the second prong of our launch strategy, which is that we need to build up enough experience working with the payers that we eventually drive towards positive coverage policies with commercial payers and then turn that over into a positive Medicare coverage policy. All that said, as you know, we don't guide, but we are looking to build on this strong start and to build up a sufficient volume of patients this year that we have those good relationships with practices and good interactions with payers. I think in terms of sort of I'll give just a couple of anecdotes just sort of how is the launch going.

I was at the IASLC Targeted Therapies conference last week, and I was really pleased to see that in the emerging therapies section, they had included Tumor Treating Fields along with all of the other new targeted therapies that are in Phase II and Phase III programs. I think that's an early sign that the lung cancer community has gone from not knowing about Tumor Treating Fields to being skeptical of Tumor Treating Fields, perhaps at the first release, to now saying, "Okay, let's understand this data in the context of the emerging landscape of treatment of lung cancer." We've been really pleased on that front and happy to add additional color if there's different areas you'd like me to go into.

Jason Bednar (Managing Director and Senior Research Analyst)

That's helpful, Frank. I do appreciate it. Maybe one follow-up just since you kind of opened the door a little bit on the payer side. I think Ashley mentioned in her prepared remarks that we should have coverage wins that start to occur this year. Just how are those discussions going? Can you talk about maybe the pacing of when you expect we'll see these? What are these payers actually looking at besides just the data? And then within that context, can you also talk about whether you expect commercial payers and Medicare to establish new codes or utilize existing codes from GBM when adding non-small cell lung? Thank you.

Frank Leonard (President)

Yeah. So I'd say, so first, it's too early to comment on payer interactions just because we're talking about the initial 20-patient cohort. But I would say that, or to comment in detail, but what I can say at a high level is that it's above our expectations so far. So we feel like we're on a good path with the payers. They really are. It's a focus. What are the payers looking at? I think first and foremost, it's the same thing that physicians look at, which is that there's a complete unmet need for treatment in the second line for non-small cell lung cancer in stage four. So that's always a good place to start with payers.

Then in terms of just the general trajectory with payers, what we've said consistently is that we think it will take us about one to two years with the commercial payers to build up coverage policies and that Medicare would lag about a year behind that. And that's still what we're thinking.

Ashley Cordova (CEO)

The only other thing I would add is, this is the beauty of having a multi-indication platform. We get to leverage our experience and the knowledge that we've built up in GBM directly into the lung cancer indication. This is a process we know how to do, and we're doing it with the same teams that have so successfully executed in GBM.

Jason Bednar (Managing Director and Senior Research Analyst)

Thanks, sorry. Anything on the coding?

Frank Leonard (President)

That's right. Sorry, I realized I didn't answer that part. Thanks, Jason. On the codes, we expect to utilize the same code. We are utilizing the same codes and expect to continue to do so.

Jason Bednar (Managing Director and Senior Research Analyst)

Okay. Thank you so much.

Operator (participant)

Thank you. Our next question comes from the line of Larry Biegelsen with Wells Fargo. Your line is now open.

Good morning. It's Leigh calling in for Larry. Thanks for taking my questions. Just first, on this call so far, you mentioned several times about improved U.S. approval rates that contribute to revenue in 2024. Can you give any more color on how much that improvement was as far as revenue or revenue growth and if we could see that improve further in 2025? And related to that, in 2024, you had some benefit from collections in the U.S. revenue. And any thoughts on how we should think about in 2025? I guess really looking at it bigger picture is when you look at consensus, is there anything the street might be missing on either of those points or any other factors? And I have a follow-up.

Christoph Brackmann (CFO)

Yeah. Thank you for the question. This is Christoph. So happy to provide some color on this. Growth in 2024 in total from improved approval rates was $42 million, driven by the U.S. Now, $22 million of that was from prior periods, so sort of a one-off windfall that we had in the prior year. Going forward, we do not comment on the exact level of approval rates, but it is at a level where we believe there is not much room for improvement, and hence we do not expect similar impacts going forward. And that's what we said in the prepared remarks. We expect the growth to be in line with Optune Gio active patients' growth. And I think that probably answers the question.

Ashley Cordova (CEO)

We do think, I think this is fairly well reflected in the consensus model.

Got it. Thank you. And just for my follow-up, you mentioned the PANOVA-3 publication. Should we expect these in 2025 or 2026? Can you share that? And related to that, you mentioned filing for both later this year. That's probably a little later than we expected. Are you just being conservative there? Is there anything we should think about as far as the process? Thank you again for taking the questions.

Yeah. No, I think I'll start there. So the short answer is yes, you should expect publication this year. In process to finalizing these submissions, we're finalizing the manuscript drafts, and they'll go in. And we are in the process of having active pre-submission discussions with the FDA. We have Breakthrough Device Designation on both of these indications, which provides us the opportunity to go back and forth with some interactive review questions prior to the formal filing, and we're in that process right now. So I wouldn't read anything into timing other than the fact that we're in that kind of pre-sub process right now, and we'll move it through to filing as soon as possible, but this is an area of probably go slow to go fast. And we're in the interactive review part of the process right now.

I do think it's important why we talk about these milestones to ground everybody, though, in the data and the TAM, right? These are both indications where we have a significant unmet need, where there is the first advance ever for these specific populations reflected in the breakthrough device designation. And both of these provide a TAM expansion opportunity that is a multiple of what we have in GBM. And as you look at the three in aggregate, you've heard us say many times before, 7X the GBM opportunity. So we are as eager to get these in market as you all are to have us have them in market because it is a real transformative opportunity for the company.

Operator (participant)

Thank you. Our next question comes from the line of Vijay Kumar with Evercore ISI. Your line is now open.

Vijay Kumar (Senior Managing Director)

Hey guys, good morning, and thanks for taking my question. My first one was on the lung side, the 52 prescriptions in Q4. Should we model a sequential step up throughout the year when you look at the 52 starting point and 20 active patients? And any goal posts on what percentage of covered lives should we expect to have some sort of coverage by end of 2025, end of 2026, etc.?

Ashley Cordova (CEO)

Yeah. It's probably too soon for us to give you specific numbers, Vijay. You'll see traction. What we'll say is that certainly you should expect it to grow throughout the course of the year. This is a growth. This is a launch, right? So you would expect these numbers to trend up. In terms of pace, what we will say is we're pleased, and it's in line with expectation, but it is focused on right patient, right time. And the same with the payer. We'll let you know as soon as we have enough track record to give you an anchor number, but we're not there yet. We would expect to exit the year 2025 with substantial experience to drive revenue in 2026. And then maybe, Frank, anything you can add on.

Frank Leonard (President)

Yeah. Vijay, thanks for the question. Just to add, in terms of color on the launch, what we're really looking at right now is the interactions we're having with our physicians and the patient profiles that are coming in. And what we're really pleased with is that we're seeing patients getting Tumor Treating Fields plus Immune Checkpoint Inhibitors, which to us is a good sign because we know that's a robust market.

Vijay Kumar (Senior Managing Director)

Understood, and sorry, just when you make that comment, substantial revenues in 2026, safe to assume at least a quarter of covered lives are under some sort of coverage exiting 2025. Would that be a reasonable assumption?

Ashley Cordova (CEO)

Yeah. Unfortunately, we're not going to be able to give you an anchor number. What we have said in the past, Vijay, is that commercial will come first. We expect that to work through the system in 2025, and commercial is about 25% of the non-small cell lung cancer opportunity. So those are statements you can't anchor to.

Vijay Kumar (Senior Managing Director)

Understood. Then a couple of P&L questions. One on China. Q4 revenues declined sequentially. Was that a timing element? Maybe talk about what's happening in China.

Ashley Cordova (CEO)

I'd say that has more to do with the ending of the amortization of the royalty. Let me remind everybody that that China number includes both their purchases for future product or royalty on sales and the amortization of other royalties in that agreement. And I would say it's largely driven by timing of purchases and the rollout of the amortization.

Vijay Kumar (Senior Managing Director)

Sorry. So when you look forward, actually, is the fiscal 2024 revenue base for China should that grow, or is that flat-ish, or should that be down?

Ashley Cordova (CEO)

What I will say is you should look at Q4 as the baseline that doesn't include in the royalty. So that's a good baseline, and then I would kick to Zai to answer their expectations about growth.

Vijay Kumar (Senior Managing Director)

Understood. And then maybe one on margins for cash flow. I think you mentioned gross margin should be down for fiscal 2025 given the new launches. Can you quantify that? And I think related, you said OpEx do a step up. Is the step up in OpEx, should that be in line with revenues, above revenues, and what are the implications for cash flows if gross margins are down and OpEx is stepping up?

Christoph Brackmann (CFO)

Yeah. Hi, James. Christoph, I can take that. So on maybe gross margin first. The gross margin in the quarter, but also for the year, was quarter was 79%, year was 77%, benefited from the increased approval rates and specifically also from the benefit that we had from prior period claims. So for the full year, that was $22 million. If you adjust that on gross margin, you would be looking at gross margins in the mid-70s. And I think that's a good sort of anchor. Now, what we also said in 2025, we expect headwinds on gross margin from two sides. One is the rollout of the new head array, which is lighter and thinner and more flexible. So a significant benefit to our patients, but it comes at this point at a higher cost.

So as we roll this out in the U.S., there will be headwind on gross margin, and the second headwind on gross margin is on the launch of the lung side. As we go at risk and prepare for or negotiate for payer coverage, that's an impact on gross margin. So long story short, we expect the gross margin to get closer to the lower 70s. It's a temporary effect, and we would then expect it to revert. On the expense side, as we are in launch mode, we would expect some incremental expenses, particularly on the sales and marketing side, and on the G&A side, it's very moderate to flattish.

Ashley Cordova (CEO)

But I would just reiterate that we feel confident that we have the financial strength and the cash balance that we need to kind of get through these growth periods.

Vijay Kumar (Senior Managing Director)

Understood. Thanks, guys.

Operator (participant)

Thank you. Our next question comes from the line of Jessica Fye with J.P. Morgan. Your line is now open.

Hey, good morning, guys. This is Callum on for Jessica. Could you talk about what's the current number of active patients on Optune for lung cancer in the U.S., and how does it compare to 20 active patients you reported at the end of 2024? And also maybe a comment on what factors do you think are driving or hindering that patient adoption here? Thank you.

Frank Leonard (President)

Yeah. So I think, first off, we don't comment on progress in intra-quarters. So I can't comment on additions from the 20 patients at year-end. But what I can in terms of the concept, or in terms of commenting on what we think is driving the adoption rate, I just highlight an anecdote or a story that I was able to interact last week with two different physicians who are now multi-indication physicians for Novocure and Tumor Treating Fields. So they've treated patients with Glioblastoma, had long-term success stories. Both then participated in medical oncology trials for us with PANOVA and LUNAR. And these two physicians now both have patients being treated on prescription order for lung cancer as well as patients in clinical trials for GBM or for other indications.

And so I think we're seeing the early benefits of being a multi-indication company, and that's really exciting for us.

Great. And maybe if I can squeeze in one more, how do you think about the drivers for revenue growth in 2025? Maybe a comment on that would be really helpful. Thank you.

Ashley Cordova (CEO)

Yeah. I would say 2025 is really going to be a kind of demand generation year, which will unlock material revenue contribution in 2026, which will come principally from the lung cancer indication. Again, we've reminded everybody that GBM is a very solid foundation that funds our investments in R&D, but that the real unlock in growth will come from the launch in lung. And then as we look ahead in 2026, we'll layer on PANOVA there with those launches. 2025 is the demand generation year.

Great. Thank you.

Operator (participant)

Thank you. Our next question comes from the line of Emily Bodnar with H.C. Wainwright. Your line is now open.

Emily Bodnar (VP of Equity Research)

Hi. Good morning. Thanks for taking the questions. I guess the first one on the lung launch with the initial patients who received prescriptions, are they mainly PD-1 naive patients, PD-1 experienced patients? And then are you seeing patients who are taking docetaxel and PD-1 inhibitors, or is it mostly one or the other? Thank you.

Frank Leonard (President)

Yeah, so I thank you for the question. This is Frank. We are seeing what I'll comment on is to say that we are seeing patients receive both docetaxel and immune checkpoint inhibitors concurrent with Tumor Treating Fields, so we're seeing both populations. We are also seeing retreatment with ICI or continuation of treatment for patients who have had ICI in the front line, and overall, we're seeing what I would describe as a good demographic mix of patients. I wouldn't go much further than that right now other than to say that those key metrics that we look at all look balanced and in the right direction.

Emily Bodnar (VP of Equity Research)

Okay. Great. Thank you.

Operator (participant)

Thank you. And I'm currently showing no further questions at this time. I'd like to hand the call back over to Bill Doyle for closing remarks.

Bill Doyle (Executive Chairman)

I'd like to conclude this call, as I always do, by first thanking all of our Novocure colleagues for their hard work and their dedication to our patients. And I'd like to thank you for your continued interest in Novocure. This is actually my 36th earnings call since our IPO in 2015. And I believe it marks a true pivot, a true moment in history of this company. As I was reflecting on the script as we were editing it and putting it together, this next chapter, as we move and grow from our foundation in GBM to a global multi-indication cancer company, is something I think that all of us should be proud of and excited for as we continue to pursue our mission to help patients extend their survivals with some of the most aggressive forms of cancer. So thank you.

Operator (participant)

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