NovoCure Limited

Good day, and thank you for standing by. Welcome to the Novocure Q4 2023 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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 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.

Good morning, and thank you for joining us to review Novocare's fourth quarter 2023 performance. I'm joined this morning by our Executive Chairman, Bill Doyle, our CEO, Asaf Danviger, and our CFO, Ashley Cordova. Other members of the executive leadership team will be available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.novacure.com, on our 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 for 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-gap-to-gap financial measures are included in our press release, earnings slides, and in our Form 8-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.

Thank you, Ingrid. At NovoCure, Our mission is to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our novel therapy tumor treating fields. In 2023, we made notable strides and reached many important milestones in our commercial, clinical research, and product development programs. Our commercial business treating patients with GBM finished the year with 9% year-over-year growth in active patients on therapy. our LUNR Phase III trial in non-small cell lung cancer met its primary endpoint. We completed enrollment of two additional Phase III trials, METIS and Panova III, and we completed enrollment of the Trident trial in January. We launched LUNR II and Panova IV, which are now initiating sites and enrolling patients, and the protocols of two new clinical trials, Keynote D58 and LUNR4 are under regulatory review. We successfully introduced our next generation arrays in several European countries and filed a PMA supplement for approval to bring the new arrays to patients in the U.S. Importantly, we have now treated over 30,000 patients since we first started commercial operations, and we ended the year with a record number of active patients on therapy. I am incredibly proud of our colleagues' achievements and look forward to a data and catalyst-driven 2024. 2024 is an important year for Novarture with more milestones on the horizon. We are laser-focused on achieving three core objectives, growing our GBM business, launching Kiki Fields in non-small cell lung cancer, and delivering our clinical and product development pipelines. Achieving these objectives will position our company for success for years to come. I'll begin this morning with a review of our commercial GBM business and non-small cell lung cancer program. Asaf will then provide clinical trial and product development updates, followed by Ashley's review of our financial performance. Our commercial GBM business is key to our long-term success. Thriving growth in our core country markets is a central objective in 2024. We ended 2023 with a record 3,755 active patients on tumor treating field therapy and generated $509 million in net revenue for the year. To achieve our growth goals, we are focused on building greater awareness and engagement with patients and prescribers, and enhancing the quality of these engagements. We are focused on seamless cross-functional alignment and a synchronized approach to driving the key levers of growth, prescriptions, patient starts, compliance, and therapy duration. Each of these inputs is critical for the best outcomes for patients and to achieving sustainable growth. We have always been a data-driven organization. As healthcare providers move to further integrate TT Field Therapy into their practices, we are determined to provide the clinical data to best inform TT Field Therapy use. A critical part of this effort is the generation of real-world evidence. Last month at J.P. Morgan, we shared a preliminary analysis of a real-world study which included all 974 newly diagnosed GBM patients who began Optune GO treatment in the U.S. in the second half of 2019. The four-year survival rate of these patients was 24%, compared to 8% for patients treated with chemotherapy alone, historically. It is worth noting that the real-world data fully support the results from the landmark EF14 Phase III clinical trials. which demonstrated 20% four-year survival for patients treated with TT fields and temozolomide. These new, real-world data will be added to, peer-reviewed, and published later this year. But the bottom line is, large, real-world data sets confirm that tumor-treating fields therapy can provide a significant survival benefit for patients struggling with this devastating disease. As we continue to generate more real-world data, we will be working to increase physician awareness of outcomes and, importantly, build patient awareness of the data. As our therapy is a unique modality, we know that physicians or patients can drive the choice of TT Fields as a therapy option. To this end, we have adjusted our organization to integrate patient support and physician support earlier in the patient journey. Direct engagement with Physicians will enable our teams to provide more hands-on assistance at the time a prescription is considered and written. We believe early engagement with patients will drive higher conversion of scripts to patient starts and deliver a more seamless therapy experience. Our second key objective in 2024 is the regulatory approval and successful launch of tumor treating fields in non-small cell lung cancer. As a reminder, last year we published the results of the Phase III LUNR trial. LUNR showed a statistically significant and clinically meaningful survival benefit for second-line, non-small-cell lung cancer patients who progressed on platinum-based chemotherapy and who used PT fields and standard therapies compared to patients who only used standard therapies. Since announcing positive top-line LUNR data, we have made steady progress towards our goal of commercial launch in 2024. In December, we filed the necessary regulatory submissions in our three major markets, the US, Europe, and Japan. In January, the FDA formally accepted our PMA submission for filing, and the PMA is now under substantive review. At the 100-day mark, which will occur in mid-March, we anticipate meeting with the FDA to discuss their next steps. Our team is fully prepared to address any questions, and we look forward to engaging with the FDA in the coming months. Outside the U.S., we are awaiting a CE mark decision in Europe and regulatory next steps in Japan. Pending regulatory approvals, our goal is to launch in Germany in the first half of 2024 and in the U.S. in the second half. Once we receive marketing approvals, we will engage payers in Germany and the U.S. to establish reimbursement. We plan to start patients on therapy in Germany and the U.S. immediately following approval using a named patient reimbursement process similar to that we used when we launched GBM. We are eager to open this new chapter at Novacure and look forward to potentially treating many more patients in the coming months. In 2024, our teams will also deliver top-line results of the MEDIS and Panova 3 clinical trials. Both trials are fully enrolled and now in patient follow-up. ASAPH will discuss these trials momentarily, but timing indicates Novacure could announce material data or new indication approvals in every quarter of 2024. It's going to be a very exciting year. Before I pass the call to Asaf to discuss our clinical program, I would like to publicly welcome our new chief medical officer, Dr. Nicholas Lepin, who joined NovoCure in January. Dr. Lepin brings a wealth of valuable experience to NovoCure as a former practicing oncologist and as a leader of clinical operations at some of the most innovative biotechnology companies. Nicholas has a proven track record of achievement, and he is making great contributions already. Nicholas and Michael Puri, our new Chief Human Resources Officer, who joined in Q3 2023, are important additions to our executive team. Welcome, Michael, and welcome, Nicholas. I'll now turn the call over to Asaf to discuss our clinical objectives.

Thank you. As Bill mentioned, we are focused on three objectives in 2024. Grow our GBM business, launch lung cancer, and deliver our pipeline. We have consolidated our clinical trial initiatives into three indications where we have proven efficacy and can address significant unmet needs. These are GBM, non-small cell lung cancer, and pancreatic cancer. OptinGeo together with imozolomide is an NCCN category one preferred therapy regimen in newly diagnosed GBM and considered standard of care, but we believe we can extend survival even further. We have two phase three trials focused on this goal. The first is Trident, which completed enrollment last month. Trident is studying the survival benefit of starting OptumGeo with chemoradiation rather than after chemoradiation, two to three months earlier than today's standard protocol. Clinical studies and preclinical research have shown that the mechanisms of action of radiation entity fields can work together to create a more pronounced cytotoxic environment for cancer cells and can potentially extend patient survival. Trident has a 24-month follow-up from last patient in. Top-run results will be available in 2026. In addition to Trident, We have submitted the IMD to the FDA and are preparing to launch the Phase III Keynote D58 trial. Keynote D58 will study Optin-Geo, Temozolomide, and the immunotherapy Pembrolizumab for the treatment of newly diagnosed GBM. Keynote D58 was initiated to confirm preclinical research and the exciting clinical data from Dr. David Trans to the top Phase II trial. At the Snow Annual Meeting in November, Dr. Tran presented updated data from To The Top. The median overall survival of patients in the trial was 24.8 months compared to 14.6 months for a match control cohort from our EF14 dataset. The To The Top Phase 2 results are very promising, and we are eager to launch Kino D58 and begin enrolling patients this year. Trident, Keynote D58, and technological improvements like our new arrays provide possibilities to further improve survival for GBM patients and demonstrate our continued commitment to the neuro-oncology field. We look forward to sharing more information on these programs in the future. We are also focused on the treatment of non-small cell lung cancer. The success of the LUNAR trial provides the foundation for a number of additional lung cancer trials. Last year, the IDE was approved for LUNAR2, and we began site initiations. LUNAR2 will evaluate the use of TT fields together with the immunotherapy pembrolizumab and platinum-based chemotherapy in first-line metastatic non-small cell lung cancer. The protocol for the Phase 2 Lunar 4 trial is under review by regulatory authorities, and we hope to launch later this year. Lunar 4 will study use of TT fields and immunotherapy in the second line, following first-line immunotherapy. We also continue to enroll patients in the Phase 2 Keynote B36 trial, evaluating TT fields therapy and pembrolizumab in first-line treatment of locally advanced or metastatic non-small cell lung cancer. Given the success of LUNAR, we believe we are just scratching the surface of the potential of TT fields in non-small cell lung cancer. We are also exploring the use of TT fields for treatment of secondary tumors. Our phase three METIS trial is studying TT fields following stereotactic radiosurgery for brain metastasis for non-small cell lung cancer. We finish enrolling METIS in March 2023 and will complete the minimum 12-month follow-up from last patient in, in the coming weeks. Once follow-up is complete, we expect to announce top-line results at the end of Q1. METIS addresses a significant unmet need in a large heterogeneous patient population. We are eager to understand if TT fields can provide benefit to these patients. In Aggregate, our non-small cell lung cancer program will include five trials, LUNAR, LUNAR2, LUNAR4, Keynote B36, and METIS. These trials allow us to study the use of TT-FILS across multiple stages of non-small cell lung cancer and have the potential to unlock availability of TT-FILS therapy for tens of thousands of patients. The third clinical program we are focused on in 2024 is pancreatic cancer. We have two ongoing clinical trials in pancreatic cancer, PANOVA-3 and PANOVA-4. The phase 3 PANOVA-3 trial is evaluating the use of PT fields together with Neb Paklitaxel and James Idaebin for the treatment of first-line locally advanced pancreatic cancer. We completed enrollment of Panova 3 last year and expect to announce top-line results in Q4 2024. We also launched the Phase 2 Panova 4 trial last year. Panova 4 is evaluating the addition of the immunotherapy atezolizumab to the regimen used in Panova 3 to treat first-line metastatic pancreatic cancer. Unfortunately, pancreatic cancer is an indication that is growing and for which there is a great unmet need. We look forward to reviewing the data from these trials as soon as possible. As previously mentioned, we are also exploring opportunities to improve our therapy through product development. In 2023, we launch our next generation arrays in Europe for GBM. Feedback has been positive. Patients have mentioned increased comfort and ease of use. In December, we filed a PMA supplement for approval to market the new arrays in the U.S. If approved, we look forward to launching in the U.S. patients in the second half of 2024. I am extremely encouraged by our achievements in 2023 and excited for the catalysts on the horizon this year. Our team is focused on our key objectives and energized to reach more patients in need. I look forward to updating you all on our progress throughout the year. Ashley will now run through our fourth quarter and full year performance.

Thank you, Asaf. The fourth quarter was another quarter of progress and execution at Novocare, setting the stage for a strong 2024. We generated $134 million in net revenue in the quarter and 509 million for the year. We ended the year with a record 3,755 active patients on therapy, an increase of 9% from year end 2022. One of our key objectives this year is to drive growth in our GBM business. As we transition into 24, Several of the complex situations that have affected our business in recent years have been largely resolved. This includes depletion of the most accessible flow of backlogged Medicare payments, achievement of a revenue baseline in our newly launched French market, and successful negotiations with German payers. The resolution of these variables serves to strengthen the foundation for net revenue growth this year. directly tied to active patients on therapy, duration of therapy, and price. Novocare's team in every function is aligned to support and enhance these drivers in 2024 and beyond. One of our victories in the fourth quarter was the continued success of our OptumGEO launch in France. Our business in France was a tailwind to our EMEA active patient count throughout the year. and contributed $8 million in the fourth quarter. This sets a strong baseline as we move into 2024. In the fourth quarter, we also saw strength in Germany, with year-over-year increases of 21% in prescriptions and 12% in active patients on therapy. As a reminder, in mid-2022, we engaged with German payers to negotiate updated contract terms that effectively paused our German business. As expected, it took approximately six quarters to recover. Moving forward, we expect the fourth quarter to serve as the baseline for our German market. Gross margin for the fourth quarter was 76%. For color, gross margin was affected by two near-term factors, investment in increased patient support capacity and the rollout of our next generation arrays. In time, we expect these factors to be offset by increased active patient counts and improved efficiencies with scale as we optimize manufacturing of our new array. Last year, we implemented portfolio prioritization and strategic restructuring initiatives to realign our business to support near-term growth and long-term value creation. As a result of these initiatives, we streamlined our operating expenses removing $60 million in residual OPEX. This streamlining will enable us to invest in future growth initiatives, like our non-small cell lung cancer launch, without increasing our cash burn. We believe in the immense potential of the tumor-treating field platform and are investing accordingly, but we also recognize the need to accelerate our path to profitability. We are confident that recent adjustments will position NovoCure to create shareholder value while achieving our mission of extending survival in some of the most aggressive forms of cancer. SG&A expenses for the fourth quarter were $99 million. Looking ahead, SG&A expenditures will be distributed to support areas with the highest growth potential and in alignment with our 2024 goals. This includes global commercial infrastructure and launch preparation ahead of our anticipated non-small cell lung cancer launch. Research development and clinical trial costs in the quarter were $54 million. Our R&D spending is largely tied to the number of ongoing clinical trials at a given moment. As the current slate of phase three trials nears conclusion, we are in the process of launching our next set of trials, including Lunar 2 and Keynote D58. Following our portfolio prioritization efforts last year, future R&D investments will be focused in areas of highest return, GVM, non-sulfur lung cancer, and pancreatic cancer. Cash and short-term investments totaled $911 million as of December 31, 2023. Our net loss for the fourth quarter was $47 million, or 45 cents per share, and adjusted EBITDA was negative $32 million. As we prepare for the potential to treat thousands of additional patients in the years to come, we are committed to ensuring incremental investments are allocated to areas that align with long-term strategic vision. Our goal is to focus on growth investments in areas of highest potential return while maintaining balance sheet strength and accelerating our path to profitability.

I'd like to close today by highlighting one of our OptumGeo patients.

Janice Armas of Los Angeles. In 2019, Janice moved to New York City, where she met Jeff, the love of her life. Avid nature enthusiasts, Janice and Jeff were soon scaling mountains across the country together. In 2021, Janice was diagnosed with GBM and began treatment with OptumGeo. Amid the fear and uncertainty of a GBM diagnosis, Janice and Jeff decided to pursue their passion. They married and moved to California to better enjoy an outdoor lifestyle. With Optune Geo on Janice's shoulder, Janice and Jeff continue to scale mountains and have plans to hike and rock climb across the globe. People like Janice are a constant reminder of the impact we can make in patients' lives, helping them reach more birthdays or anniversaries or the summits of new mountains. With that, I'll hand the call back to the operator for questions.

Thank you. As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster. One moment for our first question. And our first question comes from Jason Bednar of Piper Sandler.

Hey, good morning. Thanks for taking the questions. Can you hear me all right?

We can.

Excellent. So, Bill and Ashley, I wanted to first start with your upcoming MEDIS readout. I wanted to confirm that we should see the typical headline from you when you release the data next month. And then in what venue are you planning to present the full results? And then, do you see the fact that MEDIS is using T2 fields as a monotherapy as an advantage or a disadvantage in this trial? Is there anything to read into the fact that brain MEDs aren't one of the three areas where you consolidated your clinical research activity?

Sure. So, good morning, Jason. As you correctly underlined, we're all eagerly awaiting the data and will be announcing the top line results at the end of the quarter. We have not yet announced the venue for the full data presentation. When we get it cleaned up, we'll be applying for those slots. But I would of conferences, this will be in the fall season. It'll be too late for the spring season. And then With respect to our core focused areas, we do consider this to be part of our lung program. So METIS is studying brain metastases from non-small cell lung cancer. This is the most common form of brain METs, and so it's well within the core that we've staked out of GBM, non-small cell lung cancer, and pancreatic cancer.

But the only thing I would add there is, yes, you can expect a standard press release from us, similar to how we have handled all of the other top-line data releases for this release.

Okay, great. And then, sorry for any background noise here, but I'll try to ask my next one here quick. Just wanted to ask on duration of where. I think you've been looking at a lot of ways to keep patients on therapy longer, and the revenue of the patients could be pretty meaningful here. You have the Trident trial where you're starting patients earlier rather than waiting until after radiotherapy is complete. I think you talked about educating doctors and patients about the survival benefits of wearing Optune for longer throughout the day. I know you've got the new arrays. Those are supposed to have some clinical benefits. You started looking at potentially keeping patients on longer even after progression. So individually, those are all interesting. I guess collectively, they could be pretty impactful. Trident's not coming for a couple of years, but could we actually see benefits from some of these other items

extend duration of wear and impact revenue sooner? Hi, Jason. This is Frank Leonard. Thank you for the question.

I think that, you know, and thank you for highlighting all of the activities that we have ongoing in this area that really are focused at improving how patients and physicians use Optune to extend survival. I think I'd, you know, point directly to the new arrays that have been released in our key European markets. where we are tracking and looking at a wide array of KPIs to assess performance. And what we've seen so far, both in the metrics as well as in the anecdotes, is that the performance is meeting our expectations and looking to a positive trend of patient experience. So I think collectively, we have lots of opportunities to move the needles, and we'll continue to update you as the metrics come in.

Okay, fair enough. Maybe one more. Ashley, I know at one point we had a more formal level of financial guidance. We stepped away for a couple of different reasons, but it seems like the business is back to being predictable here. Are you willing to comment or offer any kind of forward-looking outlook, whether it's for this year or at a high level, if you're thinking out of the next few years, what to think about for growth for the business? Thank you.

Yeah, no, thanks, Jason. I appreciate the question. I mean, what we've always committed to do is providing the necessary color so that you guys can look ahead. And I would say where we feel like we need to provide detailed color, we do. So you've heard our message. We're focused on a return to growth in the GBM business. We do believe we have a clean baseline in 2023 in all of our major markets upon which you can build that growth, right? So In Germany and the U.S., we're largely through that. So if we look at 23, it's a good baseline upon which to model activation growth. And in our restructuring announcements in Q4 of last year, you heard us very directly state that we think we can run the business on the residual OPEX that we have, which will then fully support the long launch. So if you look at our OPEX run rate, I would expect us to be able to invest in the infrastructure we need to launch long at that run rate that we were running Q3, Q4. So I think with those kind of anchor messages, you have what you need to build out the model, and I would say we will continue to flag if we feel there's any additional areas where we need to adjust.

Okay. Thanks so much.

Thank you. One moment for our next question. And our next question comes from Jonathan Chang of Leerink Partners.

Hi, guys. Thanks for taking my questions. First question, ahead of a potential lung cancer approval and launch, can you talk about the pre-launch activities that are planned and ongoing, and how should we be thinking about what the initial launch trajectory could look like? And then second question, following the portfolio prioritization and strategic restructuring last year, how are you thinking about your cash position and balance sheet ahead of the two phase three readouts coming up this year? if those studies are positive, are you well positioned to advance those opportunities? Thank you.

Thank you for the question, Jonathan. This is Franklin.

In the United States, our focus has been on education and really direct engagement with potential prescribers through the advisory board process. And one of the main areas of focus is simply to work with the physicians to understand and acknowledge that there is a gap in the second line treatment of non-small cell lung cancer. And we've seen this or we've heard this very clearly now from physicians that they are not satisfied with their options for treatment after platinum failure. And we think that working with physicians to align on this core mutual understanding is the first step. And from there, we begin to educate and introduce them to tumor treating fields which we acknowledge in the medical oncology community is a new modality, and we do have to go through this education process to help them understand. We're really pleased with where we are today in terms of engaging the key KOLs and preparing the plan in the U.S. to pull through. I'd also note in Germany, we are also in the prelaunch phase where we are waiting for the CE mark And we've been able to engage in Germany with our key physicians through both pre-launch activities in non-small cell lung cancer, but also through the launch of Optum Lua for mesothelioma.

We're actively engaged in the community in Germany to help through that education curve and ultimately to prepare the market for the launch.

I mean, the one other thing, Jonathan, that I would just flag is that this is a MedTech launch curve, and as we look to the models as everybody's building this in, I would look to our GBM launch curve and not the stereotypical biotech curve, and particularly when it comes to the reimbursement dynamics.

Yeah, I think the other question you asked was with respect to our cash position for preparation for these launches, and we are prepared and it's part of our strategic plan to fully finance the non-small cell lung cancer launch that's in the budget. And as we anticipate the MEDIS readout, again, there is overlap between our key prescriber groups there too. So if you'll recall, MEDIS is treating patients after stereotactic radiosurgery. So the radiation oncologist that We engage in our GBM business as the radiation oncologist principally who is treating these patients along with the primary medical oncologist who's treating their non-small cell lung cancer. So we believe from a cash perspective we're well covered for the non-small cell lung cancer launch and a potential launch pending the outcome of medicine.

Understood. Thanks for taking the questions.

Thank you. One moment for our next question. And our next question comes from Larry Beagleson of Wells Fargo.

Hi, good morning. It's Lynn calling in for Larry. Can you hear me okay?

We can, Lynn.

Thanks for taking that.

Thanks for taking the question.

The first one is, Ashley, you guys don't provide guidance, but you did give some color on how to think about 2024 using 2023 as a base. Can you give some more detail as far as how to think about the pace of patient growth through 2024? Should we think about relatively balanced growth? Is there some sort of acceleration we should think about? And related to that, should we expect prescription growth as well in GBM in 2024? and any contribution from the lung we should look for in 24, and I have a follow-up.

Yeah, thanks, Leigh.

I mean, I will reiterate what you said and I said earlier, is that we do think 2023 is a clean baseline upon which, you know, we will grow in 2024, and that the levers of growth fundamentally will be active patient growth, which can come from prescription growth, can come from better conversion from scripts to starts, and can come from increasing duration, and we are focused on all of those levers. You know, transparently, we're not going to be able to give additional detail on what to expect there, other than to say that, you know, we do expect to see growth there. We are incentivizing our teams to grow there, and we are doing everything we can to grow there in all geographies. I do think as we look to France, there is room to, you know, continue to grow off of the strong Q4. I don't think we're done seeing kind of what a mature France market looks like, but I would just say, yes, clean 2023 baseline, and yes, we are looking ahead to 2024 growth.

Got it. And anything on lung as far as contribution in 2024?

Yeah, I know. So this is one where we would guide you to be very conservative in your 2024 model. We would expect material revenue contribution in 2025 because of the reimbursement dynamic. So we will begin on an aimed patient basis, but it does take a couple of quarters to get through those first appeal cycles. So your leading indication of adoption there will be first prescriptions and then active patients, but really revenue will begin to materially create in 2025. Got it.

Okay, thanks. And then my follow-up is, you know, when you announced the reorg plan recently, you talked about keeping expenses kind of in check until you reach a break-even point. Now, when we did the math, we get to something around $700 million or so in total revenue in order for you to reach that break-even point. And right now, you're a little over $500 million in total revenues. Can you just talk about are we, you know, thinking about it the right way as far as that $700 million mark and any color you can provide on timing of that pathway and the drivers? Obviously, it's GBM growth and lung, but, you know, any additional color and how you get there? Thanks.

Okay, well, you summarized it very well. And so I would say, sir, you know, you're on track with your thinking. I would agree with those. We have done the work to make sure that we're able to scale through that growth on our existing operating expenses. And that includes, you know, if we look at the run rate, we were exiting Q3, the hiring of the long course, you know, the cash that we removed out of the business in the back half of the year last year, we'll be able to fund that growth. And then you are correct that that path to profitability is driven by scale on a top line growth number.

So I would say you've summarized it well.

Thank you. One moment for our next question. And our next question comes from Emily Bodnar of HC Wainwright.

Hi. Good morning. Thanks for taking the questions. Could you clarify when you're expecting the CE mark for second line long in Europe? how soon after that you think you would be ready to launch. And assuming that you did receive the Europe approval, does that kind of increase your confidence for FDA approval? Thanks.

Thank you for the question. We submit our materials to the body in Europe last July, and we're expecting approval in the first half of this year. And what was the other question?

Get through to the FDA. FDA, we submitted the package for the CMA last December. And we received confirmation that it was filed. And we're just looking forward for the next step, which will be the 108 meeting which we expect it to be in the end of March.

Okay. How soon after approval in Europe would you be ready to launch?

We will be ready to launch with the approval.

Okay. So, thank you.

Thank you. One moment.

And our final question comes from Vijay Kumar of Evercore ISI.

Morning. This is Kevin Long for Vijay. One on OpEx levels. You noted a $60 million initiative in terms of OpEx savings. Inclusive of that, For the year, should we expect OpEx to grow in line with revenues, or should we see a step up given the number of clinical trials? And just to follow up, what are you expecting for free cash flow in 2024? Thank you.

Yeah, so again, that $60 million is intentional to enable that we're fully able to invest in both near-term growth and our long-term priorities, but it also has the happy coincidence of being sufficient to fund the long launch and the onboarding of our large phase three trials, which we expect to really ramp up this year, principally Lunar 2 and Keynote D58. So you should expect OpEx levels for the full year 24 to be largely in line with the full year 23, given that restructuring that we did, and I would say the same statement about cash burn.

Got it. Thank you. And on your lunar program, you noted a meeting with the FDA in mid-March. Do you expect to put out a press release then to let the street know about your communications with the FDA, or... would you provide any update in March?

Yeah, I mean, we'll make sure you have the material relevant information as we have it. The press release would tie to when the FDA has formal public announcements is what I would say.

Got it.

Thank you.

Thank you. I would now like to turn it back to Bill Doyle for closing remarks.

I'd like to start my closing remarks by reiterating my thanks to the NovoCure team for their hard work in 2023 and for the many milestones that were achieved. Our company is bigger, more complex, but our team's dedication to our mission to help patients with very difficult diagnoses is something of which I am very proud. As exciting as 23 was, we are looking forward to an even more exciting 2024. As we've discussed, we have three fully enrolled phase three trials that will read out to this year and one to follow. We're rolling our next generation arrays throughout Europe and are really excited after we get our PMA supplement approval this year. And we're going to launch a non-small cell lung cancer, our next big indication. It's extremely busy time, but extremely exciting. So I want to thank everyone on the call today for their continued interest in NovoCure, and we look forward to reporting the results of all of these activities as the year progresses.

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

Thank you.

Good day, and thank you for standing by. Welcome to the Novocure Q4 2023 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 1-1 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.

Good morning, and thank you for joining us to review Novocare's fourth quarter 2023 performance. I'm joined this morning by our Executive Chairman, Bill Doyle, our CEO, Asaf Donziger, and our CFO, Ashley Cordova. Other members of the executive leadership team will be available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.novacare.com, on our 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 for 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-gap-to-gap financial measures are included in our press release, earnings slides, and in our Form 8-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.

Thank you, Ingrid. At NovoCure, Our mission is to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our novel therapy tumor treating fields. In 2023, we made notable strides and reached many important milestones in our commercial, clinical research, and product development programs. Our commercial business treating patients with GBM finished the year with 9% year-over-year growth in active patients on therapy. our LUNAR Phase III trial in non-small cell lung cancer met its primary endpoint. We completed enrollment of two additional Phase III trials, METIS and PANOVA III, and we completed enrollment of the TRIDEN trial in January. We launched LUNAR II and PANOVA IV, which are now initiating sites and enrolling patients, and the protocols of two new clinical trials, Keynote D58, and Lunar 4 are under regulatory review. We successfully introduced our next generation arrays in several European countries and filed a PMA supplement for approval to bring the new arrays to patients in the U.S. Importantly, we have now treated over 30,000 patients since we first started commercial operations, and we ended the year with a record number of active patients on therapy. I am incredibly proud of our colleagues' achievements and look forward to a data and catalyst-driven 2024. 2024 is an important year for NovoCure with more milestones on the horizon. We are laser-focused on achieving three core objectives, growing our GBM business, launching TT fields in non-small cell lung cancer, and delivering our clinical and product development pipelines. Achieving these objectives will position our company for success for years to come. I'll begin this morning with a review of our commercial GBM business and non-small cell lung cancer program. Asaf will then provide clinical trial and product development updates, followed by Ashley's review of our financial performance. Our commercial GBM business is key to our long-term success. Thriving growth in our core country markets is a central objective in 2024. We ended 2023 with a record 3,755 active patients on tumor treating field therapy and generated $509 million in net revenue for the year. To achieve our growth goals, we are focused on building greater awareness and engagement with patients and prescribers, and enhancing the quality of these engagements. We are focused on seamless cross-functional alignment and a synchronized approach to driving the key levers of growth, prescriptions, patient starts, compliance, and therapy duration. Each of these inputs is critical for the best outcomes for patients and to achieving sustainable growth. We have always been a data-driven organization. As healthcare providers move to further integrate TT Fields therapy into their practices, we are determined to provide the clinical data to best inform TT Fields therapy use. A critical part of this effort is the generation of real-world evidence. Last month at J.P. Morgan, we shared a preliminary analysis of a real-world study which included all 974 newly diagnosed GBM patients who began Optune GO treatment in the U.S. in the second half of 2019. The four-year survival rate of these patients was 24%, compared to 8% for patients treated with chemotherapy alone, historically. It is worth noting that the real-world data fully support the results from the landmark EF14 Phase III clinical trials. which demonstrated 20% four-year survival for patients treated with TT fields and temozolomide. These new real-world data will be added to, peer-reviewed, and published later this year. But the bottom line is, large, real-world data sets confirm that tumor-treating fields therapy can provide a significant survival benefit for patients struggling with this devastating disease. As we continue to generate more real-world data, we will be working to increase physician awareness of outcomes and, importantly, build patient awareness of the data. As our therapy is a unique modality, we know that physicians or patients can drive the choice of TPfields as a therapy option. To this end, we have adjusted our organization to integrate patient support and physician support earlier in the patient journey. Direct engagement with Physicians will enable our teams to provide more hands-on assistance at the time a prescription is considered and written. We believe early engagement with patients will drive higher conversion of scripts to patient starts and deliver a more seamless therapy experience. Our second key objective in 2024 is the regulatory approval and successful launch of tumor treating fields in non-small cell lung cancer. As a reminder, last year we published the results of the Phase III LUNR trial. LUNR showed a statistically significant and clinically meaningful survival benefit for second-line, non-small-cell lung cancer patients who progressed on platinum-based chemotherapy and who used PT fields and standard therapies compared to patients who only used standard therapies. Since announcing positive top-line LUNR data, we have made steady progress towards our goal of commercial launch in 2024. In December, we filed the necessary regulatory submissions in our three major markets, the US, Europe, and Japan. In January, the FDA formally accepted our PMA submission for filing, and the PMA is now under substantive review. At the 100-day mark, which will occur in mid-March, we anticipate meeting with the FDA to discuss their next steps. Our team is fully prepared to address any questions, and we look forward to engaging with the FDA in the coming months. Outside the U.S., we are awaiting a CE mark decision in Europe and regulatory next steps in Japan. Pending regulatory approvals, our goal is to launch in Germany in the first half of 2024 and in the U.S. in the second half. Once we receive marketing approvals, we will engage payers in Germany and the U.S. to establish reimbursement. We plan to start patients on therapy in Germany and the U.S. immediately following approval using a named patient reimbursement process similar to that we used when we launched GBM. We are eager to open this new chapter at Novacure and look forward to potentially treating many more patients in the coming months. In 2024, our teams will also deliver top-line results of the MEDIS and Panova 3 clinical trials. Both trials are fully enrolled and now in patient follow-up. Asaf will discuss these trials momentarily, but timing indicates Novacure could announce material data or new indication approvals in every quarter of 2024. It's going to be a very exciting year. Before I pass the call to Asaf to discuss our clinical program, I would like to publicly welcome our new chief medical officer, Dr. Nicholas Lepin, who joined NovoCure in January. Dr. Lepin brings a wealth of valuable experience to NovoCure as a former practicing oncologist and as a leader of clinical operations at some of the most innovative biotechnology companies. Nicholas has a proven track record of achievement, and he is making great contributions already. Nicholas and Michael Puri, our new Chief Human Resources Officer, who joined in Q3 2023, are important additions to our executive team. Welcome, Michael, and welcome, Nicholas. I'll now turn the call over to Asaf to discuss our clinical objectives.

Thank you. As Bill mentioned, we are focused on three objectives in 2024. Grow our GBM business, launch lung cancer, and deliver our pipeline. We have consolidated our clinical trial initiatives into three indications where we have proven efficacy and can address significant unmet needs. These are GBM, non-small cell lung cancer, and pancreatic cancer. OptiumGeo, together with imozolomide, is an NCCN Category 1 preferred therapy regimen in newly diagnosed GBM and considered standard of care. But we believe we can extend survival even further. We have two phase three trials focused on this goal. The first is Trident, which completed enrollment last month. Trident is studying the survival benefit of starting OptiumGeo with chemoradiation rather than after chemoradiation, two to three months earlier than today's standard protocol. Clinical studies and preclinical research have shown that the mechanisms of action of radiation entity fields can work together to create a more pronounced cytotoxic environment for cancer cells and can potentially extend patient survival. Trident has a 24-month follow-up from last patient in. Top-run results will be available in 2026. In addition to Trident, We have submitted the IMD to the FDA and are preparing to launch the Phase III Keynote D58 trial. Keynote D58 will study Optin-Geo, Temozolomide, and the immunotherapy Pembrolizumab for the treatment of newly diagnosed GBM. Keynote D58 was initiated to confirm preclinical research and the exciting clinical data from Dr. David Trans to the top Phase II trial. At the Snow Annual Meeting in November, Dr. Tran presented updated data from To the Top. The median overall survival of patients in the trial was 24.8 months compared to 14.6 months for a match control cohort from our EF14 dataset. The To the Top Phase 2 results are very promising, and we are eager to launch Kino D58 and begin enrolling patients this year. Trident, Keynote D58, and technological improvements like our new arrays provide possibilities to further improve survival for GBM patients and demonstrate our continued commitment to the neuro-oncology field. We look forward to sharing more information on these programs in the future. We are also focused on the treatment of non-small cell lung cancer. The success of the LUNAR trial provides the foundation for a number of additional lung cancer trials. Last year, the IDE was approved for LUNAR2, and we began site initiations. LUNAR2 will evaluate the use of TT fields together with the immunotherapy pembrolizumab and platinum-based chemotherapy in first-line metastatic non-small-cell lung cancer. The protocol for the Phase 2 Lunar 4 trial is under review by regulatory authorities, and we hope to launch later this year. Lunar 4 will study use of TT fields and immunotherapy in the second line, following first-line immunotherapy. We also continue to enroll patients in the Phase 2 Keynote B36 trial, evaluating TT fields therapy and pembrolizumab in first-line treatment of locally advanced or metastatic non-small cell lung cancer. Given the success of LUNAR, we believe we are just scratching the surface of the potential of TT fields in non-small cell lung cancer. We are also exploring the use of TT fields for treatment of secondary tumors. Our phase three METIS trial is studying TT fields following stereotactic radiosurgery for brain metastases for non-small cell lung cancer. We finish enrolling METIS in March 2023 and will complete the minimum 12-month follow-up from last patient in, in the coming weeks. Once follow-up is complete, we expect to announce top-line results at the end of Q1. METIS addresses a significant unmet need in a large heterogeneous patient population. We are eager to understand if TT fields can provide benefit to these patients. In aggregate, our non-small cell lung cancer program will include five trials, LUNAR, LUNAR2, LUNAR4, Keynote B36, and METIS. These trials allow us to study the use of TTIFILS across multiple stages of non-small cell lung cancer and have the potential to unlock availability of TTIFILS therapy for tens of thousands of patients. The third clinical program we are focused on in 2024 is pancreatic cancer. We have two ongoing clinical trials in pancreatic cancer, Panova 3 and Panova 4. The phase 3 Panova 3 trial is evaluating the use of PT fields together with Neb Paklitaxel and James Idaven for the treatment of first-line locally advanced pancreatic cancer. We completed enrollment of Panova 3 last year and expect to announce top-line results in Q4 2024. We also launched the Phase 2 Panova 4 trial last year. Panova 4 is evaluating the addition of the immunotherapy atezolizumab to the regimen used in Panova 3 to treat first-line metastatic pancreatic cancer. Unfortunately, pancreatic cancer is an indication that is growing and for which there is a great unmet need. We look forward to reviewing the data from these trials as soon as possible. As previously mentioned, we are also exploring opportunities to improve our therapy through product development. In 2023, we launch our next generation arrays in Europe for GBM. Feedback has been positive. patients have mentioned increased comfort and ease of use. In December, we filed a PMA supplement for approval to market the new arrays in the U.S. If approved, we look forward to launching in the U.S. patients in the second half of 2024. I am extremely encouraged by our achievements in 2023 and excited for the catalysts on the horizon this year. Our team is focused on our key objectives and energized to reach more patients in need. I look forward to updating you all on our progress throughout the year. Ashley will now run through our fourth quarter and full year performance.

Thank you, Asaf. The fourth quarter was another quarter of progress and execution at Novocare, setting the stage for a strong 2024. We generated $134 million in net revenue in the quarter and 509 million for the year. We ended the year with a record 3,755 active patients on therapy, an increase of 9% from year end 2022. One of our key objectives this year is to drive growth in our GVM business. As we transition into 24, Several of the complex situations that have affected our business in recent years have been largely resolved. This includes depletion of the most accessible flow of backlogged Medicare payments, achievement of a revenue baseline in our newly launched French market, and successful negotiations with German payers. The resolution of these variables serves to strengthen the foundation for net revenue growth this year. directly tied to active patients on therapy, duration of therapy, and price. Novocare's team in every function is aligned to support and enhance these drivers in 2024 and beyond. One of our victories in the fourth quarter was the continued success of our OptumGEO launch in France. Our business in France was a tailwind to our EMEA active patient count throughout the year. and contributed $8 million in the fourth quarter. This sets a strong baseline as we move into 2024. In the fourth quarter, we also saw strength in Germany with year over year increases of 21% in prescriptions and 12% in active patients on therapy. As a reminder, in mid-2022, we engaged with German payers to negotiate updated contract terms that effectively paused our German business. As expected, it took approximately six quarters to recover. Moving forward, we expect the fourth quarter to serve as the baseline for our German market.

Gross margin for the fourth quarter was 76%.

For color, gross margin was affected by two near-term factors, investment in increased patient support capacity and the rollout of our next generation arrays. In time, we expect these factors to be offset by increased active patient counts and improved efficiencies with scale as we optimize manufacturing of our new array. Last year, we implemented portfolio prioritization and strategic restructuring initiatives to realign our business to support near-term growth and long-term value creation. As a result of these initiatives, we streamlined our operating expenses removing $60 million in residual OPEX. This streamlining will enable us to invest in future growth initiatives, like our non-small cell lung cancer launch, without increasing our cash burn. We believe in the immense potential of the tumor treating field platform and are investing accordingly, but we also recognize the need to accelerate our path to profitability. We are confident that recent adjustments will position NovoCure to create shareholder value while achieving our mission of extending survival in some of the most aggressive forms of cancer. SG&A expenses for the fourth quarter were $99 million. Looking ahead, SG&A expenditures will be distributed to support areas with the highest growth potential and in alignment with our 2024 goals. This includes global commercial infrastructure and launch preparation ahead of our anticipated non-small cell lung cancer launch. Research development and clinical trial costs in the quarter were $54 million. Our R&D spending is largely tied to the number of ongoing clinical trials at a given moment. As the current slate of phase three trials nears conclusion, we are in the process of launching our next set of trials, including Lunar 2 and Keynote D58. Following our portfolio prioritization efforts last year, future R&D investments will be focused in areas of highest return, GVM, non-sulfur lung cancer, and pancreatic cancer. Cash and short-term investments totaled $911 million as of December 31, 2023. Our net loss for the fourth quarter was $47 million, or 45 cents per share, and adjusted EBITDA was negative $32 million. As we prepare for the potential to treat thousands of additional patients in the years to come, we are committed to ensuring incremental investments are allocated to areas that align with long-term strategic vision. Our goal is to focus on growth investments in areas of highest potential return while maintaining balance sheet strength and accelerating our path to profitability.

I'd like to close today by highlighting one of our OptumGeo patients.

Janice Armstead of Los Angeles. In 2019, Janice moved to New York City, where she met Jeff, the love of her life. Avid nature enthusiasts, Janice and Jeff were soon scaling mountains across the country together. In 2021, Janice was diagnosed with GBM and began treatment with OpcuneGeo. Amid the fear and uncertainty of a GBM diagnosis, Janice and Jeff decided to pursue their passion. They married and moved to California to better enjoy an outdoor lifestyle. With Optune Geo on Janice's shoulder, Janice and Jeff continue to scale mountains and have plans to hike and rock climb across the globe. People like Janice are a constant reminder of the impact we can make in patients' lives, helping them reach more birthdays or anniversaries or the summits of new mountains. With that, I'll hand the call back to the operator for questions.

Thank you. As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Please stand by while we compile the Q&A roster. One moment for our first question. And our first question comes from Jason Bednar of Piper Sandler.

Hey, good morning. Thanks for taking the questions. Can you hear me all right?

We can.

Excellent.

So, Bill and Ashley, I wanted to first start with your upcoming MEDIS readout. I wanted to confirm that we should see the typical headline from you when you release the data next month. And then in what venue are you planning to present the full results? And then, do you see the fact that MEDIS is using T2 fields as a monotherapy as an advantage or a disadvantage in this trial? Is there anything to read into the fact that brain MEDs aren't one of the three areas where you consolidated your clinical research activity?

Sure. So, good morning, Jason. As you correctly underlined, we're all eagerly awaiting the data and will be announcing the the top line results at the end of the quarter. We have not yet announced the venue for the full data presentation. When we get it cleaned up, we'll be applying for those slots. But I would of conferences, this will be in the fall season. It'll be too late for the spring season. And then With respect to our core focused areas, we do consider this to be part of our lung program. So METIS is studying brain metastases from non-small cell lung cancer. This is the most common form of brain METS, and so it's well within the core that we've staked out of GBM, non-small cell lung cancer, and pancreatic cancer.

But the only thing I would add there is, yes, you can expect a standard press release from us, similar to how we have handled all of the other top-line data releases for this release.

Okay, great. And then, sorry for any background noise here, but I'll try to ask my next one here quick. Just wanted to ask on duration of wear. I think you've been looking at a lot of ways to keep patients on therapy longer, and the revenue of the patients could be pretty meaningful here. You have the Trident trial where you're starting patients earlier rather than waiting until after radiotherapy is complete. I think you talked about educating doctors and patients about the survival benefits of wearing Optune for longer throughout the day. I know you've got the new arrays. Those are supposed to have some clinical benefits. You started looking at potentially keeping patients on longer even after progression. So individually, those are all interesting. I guess collectively, they could be pretty impactful. Trident's not coming for a couple of years, but could we actually see benefits from some of these other items

extend duration of wear and impact revenue sooner. Hi, Jason. This is Frank Leonard. Thank you for the question.

I think that, you know, and thank you for highlighting all of the activities that we have ongoing in this area that really are focused at improving how patients and physicians use Optune to extend survival. I think I'd, you know, point directly to the new arrays that have been released in our key European markets. where we are tracking and looking at a wide array of KPIs to assess performance. And what we've seen so far both in the metrics as well as in the anecdotes is that the performance is meeting our expectations and looking to a positive trend of patient experience. So I think collectively we have lots of opportunities to move the needles and we'll continue to update you as the metrics come in.

Okay, fair enough. Maybe one more. Ashley, I know at one point we had a more formal level of financial guidance. We stepped away for a couple of different reasons, but it seems like the business is back to being predictable here. Are you willing to comment or offer any kind of forward-looking outlook, whether it's for this year or at a high level, if you're thinking out of the next few years, what to think about for growth for the business? Thank you.

Yeah, no, thanks, Jason. I appreciate the question. I mean, what we've always committed to do is providing the necessary color so that you guys can look ahead. And I would say where we feel like we need to provide detailed color, we do. So you've heard our message. We're focused on a return to growth in the GBM business. We do believe we have a clean baseline in 2023 in all of our major markets upon which you can build that growth, right? So In Germany and the U.S., we're largely through that. So if we look at 23, it's a good baseline upon which to model activation growth. And in our restructuring announcements in Q4 of last year, you heard us very directly state that we think we can run the business on the residual off-ex that we have, which will then fully support the long launch. So if you look at our off-ex run rate, I would expect us to be able to invest in the infrastructure we need to launch long at that run rate that we were running Q3, Q4. So I think with those kind of anchor messages, you have what you need to build out the model, and I would say we will continue to flag if we feel there's any additional areas where we need to adjust.

Okay. Thanks so much.

Thank you. One moment for our next question. And our next question comes from Jonathan Chang of Leering Partners.

Hi, guys. Thanks for taking my questions. First question, ahead of a potential lung cancer approval and launch, can you talk about the pre-launch activities that are planned and ongoing, and how should we be thinking about what the initial launch trajectory could look like? And then second question, following the portfolio prioritization and strategic restructuring last year, how are you thinking about your cash position and balance sheet ahead of the two phase three readouts coming up this year? if those studies are positive, are you well positioned to advance those opportunities?

Thank you.

Thank you for the question, Jonathan. This is Franklin.

In the United States, our focus has been on education and really direct engagement with potential prescribers through the advisory board process. And one of the main areas of focus is simply to work with the physicians to understand and acknowledge that there is a gap in the second line treatment of non-small cell lung cancer. And we've seen this or we've heard this very clearly now from physicians that they are not satisfied with their options for treatment after platinum failure. And we think that working with physicians to align on this core mutual understanding is the first step. And from there, we begin to educate and introduce them to tumor treating fields which we acknowledge in the medical oncology community is a new modality, and we do have to go through this education process to help them understand. We're really pleased with where we are today in terms of engaging the key KOLs and preparing the plan in the U.S. to pull through. I'd also note in Germany, we are also in the pre-launch phase where we are waiting for the CE mark And we've been able to engage in Germany with our key physicians through both pre-launch activities in non-small cell lung cancer, but also through the launch of Optum Lua for mesothelioma.

We engaged in the community in Germany to help through that education curve and ultimately to prepare the market for the launch.

I mean, the one other thing, Jonathan, that I would just flag is that this is a MedTech launch curve, and as we look to the models as everybody's building this in, I would look to our GVM launch curve and not the stereotypical biotech curve, and particularly when it comes to the reimbursement dynamics.

Yeah, I think the other question you asked was with respect to our cash position for preparation for these launches, and we are prepared and it's part of our strategic plan to fully finance the non-small cell lung cancer launch that's in the budget. And as we anticipate the MEDIS readout, again, there is overlap between our key prescriber groups there too. So if you'll recall, MEDIS is treating patients after stereotactic radiosurgery. So the radiation oncologist that We engage in our GBM business as the radiation oncologist principally who is treating these patients along with the primary medical oncologist who's treating their non-small cell lung cancer. So we believe from a cash perspective we're well covered for the non-small cell lung cancer launch and a potential launch pending the outcome of medicine.

Understood. Thanks for taking the questions.

Thank you. One moment for our next question.

And our next question comes from Larry Beagleson of Wells Fargo.

Hi, good morning. It's Lynn calling in for Larry. Can you hear me okay?

We can, Lynn.

Thanks for taking the question.

The first one is,

Ashley, you guys don't provide guidance, but you did give some color on how to think about 2024 using 2023 as a base. Can you give some more detail as far as how to think about the pace of patient growth through 2024? Should we think about relatively balanced growth? Is there some sort of acceleration we should think about? And related to that, should we expect prescription growth as well in GBM in 2024? and any contribution from the lung we should look for in 24, and I have a follow-up.

Yeah, thanks, Leigh.

I mean, I will reiterate what you said and I said earlier, is that we do think 2023 is a clean baseline upon which, you know, we will grow in 2024, and that the levers of growth fundamentally will be active patient growth, which can come from prescription growth, can come from better conversion from scripts to starts, and can come from increasing duration, and we are focused on all of those levers. You know, transparently, we're not going to be able to give additional detail on what to expect there, other than to say that, you know, we do expect to see growth there. We are incentivizing our teams to grow there, and we are doing everything we can to grow there in all geographies. I do think as we look to France, there is room to, you know, continue to grow off of the strong Q4. I don't think we're done seeing kind of what a mature France market looks like, but I would just say, yes, clean 2023 baseline, and yes, we are looking ahead to 2024 growth.

Got it. And anything on lung as far as contribution in 2024?

Yeah, so this is one where we would guide you to be very conservative in your 2024 model. We would expect material revenue contribution in 2025 because of the reimbursement dynamic. So we will begin on an aimed patient basis, but it does take a couple of quarters to get through those first appeal cycles. So your leading indication of adoption there will be first prescriptions and then active patients, but really revenue will begin to materially create in 2025. Got it.

Okay, thanks. And then my follow-up is, you know, when you announced the reorg plan recently, you talked about keeping expenses kind of in check until you reach a break-even point. Now, when we did the math, we get to something around $700 million or so in total revenue in order for you to reach that break-even point. And right now, you're a little over $500 million in total revenues. Can you just talk about are we, you know, thinking about it the right way as far as that $700 million mark and any color you can provide on timing of that pathway and the drivers? Obviously, it's GBM growth and lung, but, you know, any additional color and how you get there? Thanks.

Okay, well, you summarized it very well. And so I would say, sir, you know, you're on track with your thinking. I would agree with those. We have done the work to make sure that we're able to scale through that growth on our existing operating expenses. And that includes, you know, if we look at the run rate, we were exiting Q3, the hiring of the long course, you know, the cash that we removed out of the business in the back half of the year last year, we'll be able to fund that growth. And then you are correct that that path to profitability is driven by scale on a top line growth number.

So I would say you've summarized it well.

Thank you. One moment for our next question. And our next question comes from Emily Bodnar of HC Wainwright.

Hi. Good morning. Thanks for taking the questions. Could you clarify when you're expecting the CE mark for second line long in Europe? how soon after that you think you would be ready to launch. And assuming that you did receive the Europe approval, does that kind of increase your confidence for FDA approval? Thanks.

Thank you for the question. We submit our materials to the body in Europe last July, and we're expecting approval in the first half of this year. And what was the other question?

Stay true to the FDA. FDA, we submitted the package for the CMA last December, and we received confirmation that it was filed. And we're just looking forward for the next step, which will be the 100-day meeting which we expect it to be in the end of March.

Okay. How soon after approval in Europe would you be ready to launch?

We will be ready to launch with the approval.

Okay. So, thank you. Thank you. One moment. And our final question comes from Vijay Kumar of Evercore ISI.

Morning. This is Kevin Long for Vijay. One on OpEx levels. You noted a $60 million initiative in terms of OpEx savings. Inclusive of that, For the year, should we expect OpEx to grow in line with revenues, or should we see a step up given the number of clinical trials? And just to follow up, what are you expecting for free cash flow in 2024? Thank you.

Yeah, so again, that $60 million is intentional to enable that we're fully able to invest in both near-term growth and our long-term priorities, but it also has the happy coincidence of being sufficient to fund the long launch and the onboarding of our large phase three trials, which we expect to really ramp up this year, principally Lunar 2 and Keynote D58. So you should expect OpEx levels for the full year 24 to be largely in line with the full year 23, given that restructuring that we did, and I would say the same statement about cash burn.

Got it. Thank you. And on your lunar program, you noted a meeting with the FDA in mid-March. Do you expect to put out a press release then to let the street know about your communications with the FDA, or... would you provide any update in March?

Yeah, I mean, we'll make sure you have the material relevant information as we have it. The press release would tie to when the FDA has formal public announcements is what I would say.

Got it.

Thank you.

Thank you. I would now like to turn it back to Bill Doyle for closing remarks.

I'd like to start my closing remarks by reiterating my thanks to the NovoCure team for their hard work in 2023 and for the many milestones that were achieved. Our company is bigger, more complex, but our team's dedication to our mission to help patients with very difficult diagnoses is something of which I am very proud. As exciting as 23 was, we are looking forward to an even more exciting 2024. As we've discussed, we have three fully enrolled phase three trials that will read out to this year and one to follow. We're rolling our next generation arrays throughout Europe and are really excited after we get our PMA supplement approval this year. And we're going to launch a non-small cell lung cancer, our next big indication. It's extremely busy time, but extremely exciting. So I want to thank everyone on the call today for their continued interest in NovoCure, and we look forward to reporting the results of all of these activities as the year progresses.

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