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 speakers' presentation there will be a question-and-answer session. 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 NovoCure’s fourth quarter 2023 performance. I am joined this morning by our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; and our CFO, Ashley Cordova. 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 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 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 thus 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 8-K filed with the SEC today. These materials can also be accessed in 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 3 trial in non-small cell lung cancer met its primary endpoint. We completed enrollment of two additional Phase 3 trials; METIS and PANOVA-3, and we completed enrollment of the TRIDENT trial in January. We launched LUNAR-2 and PANOVA-4, 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 TTFields 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. Driving growth in our core country markets is a central objective in 2024. We ended 2023 with a record 3755 active patients on Tumor Treating Fields 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 TTFields therapy into their practices, we are determined to provide the clinical data to best inform TTFields therapy use. A critical part of this effort is the generation of real-world evidence. 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 TTFields 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 3 LUNAR trial. LUNAR 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 TTFields and standard therapies compared to patients who only used standard therapies. Since announcing positive top line LUNAR 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 U.S., 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 NovoCure 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 METIS 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 NovoCure could announce material data or new indication approvals in every quarter of 2024. It is going to be a very exciting year.

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. TRIDENT is studying the survival benefit of starting Optune Gio with chemo radiation rather than after chemo radiation, two to three months earlier than today's standard protocol. Clinical studies and preclinical research have shown that the mechanisms of action of radiation and TTFields can work together to create a more pronounced cytotoxic environment for cancer cells and can potentially extend patient survival. At the SNO annual meeting in November, Dr. Tran presented updated data from the trial. The median overall survival of patients in the trial was 24.8 months compared to 14.6 months for a matched control cohort from our EF-14 data set. The top-of-the-top Phase 2 results are very promising and we are eager to launch KEYNOTE 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 ID was approved for LUNAR-2 and we began site initiations. LUNAR-2 will evaluate the use of TTFields 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 the use of TTFields and immunotherapy in the second line following first line immunotherapy. We also continue to enroll patients in the Phase 2 KEYNOTE B36 trial evaluating TTFields therapy and pembrolizumab in the 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 TTFields in non-small cell lung cancer. We are also exploring the use of TTFields for treatment of secondary tumors. Our Phase 3 METIS trial is studying TTFields following stereotactic radiosurgery for brain metastasis for non-small cell lung cancer. We finished enrolling METIS in March 2023 and will complete the minimum twelve months follow-up from the last patient 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 TTFields can provide benefit to these patients. In aggregate, our non-small cell lung cancer program will include five trials, LUNAR, LUNAR-2, LUNAR-4, KEYNOTE B36, and METIS. These trials allow us to study the use of TTFields across multiple stages of non-small cell lung cancer and have the potential to unlock the availability of TTFields therapy for tens of thousands of patients.

Thank you, Asaf. The fourth quarter was another quarter of progress and execution at NovoCure, 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 3755 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. NovoCure'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 Optune Gio 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 the manufacturing of our new arrays. Last year, we implemented portfolio prioritization and strategically 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 Fields 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 would 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 3 trials nears conclusion, we are in the process of launching our next set of trials, including LUNAR-2 and KEYNOTE B58. Following our portfolio prioritization efforts last year, future R&D investments will be focused in areas of highest return; GBM, non-small cell 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 $0.45 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 Optune Gio patients, Janice Arms 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 Optune Gio. 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 Gio on Janice's shoulder, Janice and Jeff continued 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.

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 METIS 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 METIS is using TTFields as a monotherapy as an advantage or a disadvantage in this trial? Is there anything to read into the fact that brain mets aren’t one of the three areas where you consolidated your clinical research activities?

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 anticipate this will be in the fall season. It will 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 implications could be pretty meaningful. You have the TRIDENT trial where you’re starting patients earlier rather than wait until after radiotherapy is complete. I think you’ve 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 can be pretty impactful. TRIDENT is 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 your question. I appreciate you highlighting the various activities we have underway in this area aimed at enhancing how patients and physicians utilize Optune to improve survival. I want to point out the new arrays we’ve launched in our key European markets, where we are monitoring a wide range of key performance indicators to evaluate our performance. So far, both the metrics and anecdotes indicate that the performance is meeting our expectations, reflecting a positive trend in patient experience. We see many opportunities to make progress and will keep you updated as new metrics are available.

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, think about growth for the business? Thank you.

No, 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. So if we look at 2023, it’s a good baseline upon which to model active patient 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 lung 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 lung at that run rate that we were running in 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.

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 3 readouts coming up this year? If those studies are positive, are you well positioned to advance in those opportunities? Thank you.

Thank you for the question, Jonathan. We are concentrating on education and direct engagement with potential prescribers through our advisory board process. A primary focus is to collaborate with physicians to recognize the gap in second-line treatment for non-small cell lung cancer. Physicians have clearly expressed their dissatisfaction with available treatment options after platinum failure. We believe that aligning with physicians on this crucial understanding is the first step. From there, we will educate them about Tumor Treating Fields, which is acknowledged as a new modality in the medical oncology community that requires a thorough education process. We are pleased with our current progress in engaging key opinion leaders and preparing our strategy in the U.S. for implementation. Additionally, in Germany, we are in the pre-launch phase and awaiting the CE Mark. We have successfully engaged key physicians in Germany through pre-launch activities for non-small cell lung cancer and the launch of Optune Lua for mesothelioma, assisting the community with the education process and preparing 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 is building this in, I would look to our GBM launch curve and not the stereotypical biotech curve in particular when it comes to the reimbursement dynamics.

Yes, 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 METIS readout, again, there is overlap between our key prescriber groups there, too. So if you’ll recall, METIS is treating patients after stereotactic radio surgery. So the radiation oncologists that we engage in our GBM business is 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.

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

We can.

Thanks for taking that. The first one is, actually, 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 active 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 that we should look for in 2024? And I have a follow-up.

Yes. Thanks, Lynn. I mean, I will reiterate, what you said, and I said earlier, is that we do think 2023 is a clean baseline upon which we will grow in 2024. And that those 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. Transparently, we're not going to be able to give additional detail on what to expect there other than to say that 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 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?

Yes. 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 dynamics. So we will begin on an aimed patient basis, but there it does take a couple of quarters to get through those first appeal cycles. So your leading indicator of adoption there will be first prescriptions and then active patients, but really, revenue will begin to materially creep in 2025.

Got it. Okay, thanks. And then my follow-up is, when you announced the odd plan recently, you talked about keeping expenses kind of in check until you reach a breakeven 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 breakeven point. And right now, you're a little over $500 million in total revenue. Can you just talk about, are we 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, its GBM growth and lung, but any additional color on how you get there? Thanks.

I'll say Lynn, you summarized it very well. Is that what I would say? So 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, if we look at the run rate we were exiting Q3 the hiring of the lung board the cash that we removed out of the business in the back half of the year last year will 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.

Hi, good morning. Thanks for taking the questions. Could you clarify when you're expecting the CE Mark for second line lung in Europe and 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 your question. We submitted our materials to the regulatory body in Europe last July and we're expecting approval in the first half of this year. And what was the other question?

Read through to the FDA.

FDA, we submitted the package for the PMA 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 meetings, which we expect 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.

Good morning. This is Kevin on 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.

Yes. 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 lung launch and the onboarding of our large Phase 3 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 2024 to be largely in line with the full year 2023, 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?

Yes, 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.

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 2023 was, we are looking forward to an even more exciting 2024. As we've discussed, we have three fully enrolled Phase 3 trials that will read out this year and one to follow. We're rolling our next generation arrays throughout Europe and are really excited about our potential launch of non-small cell lung cancer, our next big indication. It's an 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.