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spk06: Good morning, everyone, and thank you for joining us to review Novocure's fourth quarter and full year 2022 performance. I'm joined on the phone by our Executive Chairman, Bill Doyle, our CEO, Asaf Dhanziger, and our CFO, Ashley Cordova. Other members of our executive leadership team are also on the call and available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.novacure.com, under quarterly reports on our investor relations page. Before we begin, 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 as required by law. Where appropriate, we'll refer to non-GAAP financial measures to evaluate our business, specifically adjusted EBITDA, a measure of earnings before interest, taxes, depreciation, amortization, and share-based compensation. We believe Adjusted EBITDA is an important metric as it removes the impact of earnings of triple-two, 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 8K file with the SEC today. These materials can also be accessed from our 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.
spk01: Thank you, Ingrid, and good morning, everyone. NovoCure was founded in 2000 to exploit the novel finding that electric fields can be harnessed to kill cancer cells and extend cancer patient survival. Since 2000, we have treated over 27,000 patients, built a resilient commercial business, and invested in extensive clinical and product development programs to enhance and expand the incredible capabilities of tumor treating fields therapy for the treatment of solid tumor cancers. In 2022, Novacure achieved material milestones. In our commercial business, we generated $538 million in net revenue, received approval for and launched Optune in Canada, and finalized contract terms to establish national reimbursement in France pending final publication. We successfully rolled out our next-generation arrays in Austria, which are thinner, lighter, and may deliver more energy to patients. And we made significant progress in our clinical programs, announcing the pivotal lunar study in non-small-cell lung cancer met its primary overall survival endpoint, completing the pivotal Innovate 3 interim analysis with final Innovate 3 data anticipated later this year, and announcing positive data in our pilot gastric cancer study and in Dr. David Tran's to-the-top pilot study, which explored treating GBM patients with TT fields plus temozolomide and the immune checkpoint inhibitor pembrolizumab. Last week, we announced completion of enrollment of our pivotal Panova 3 study in pancreatic cancer. And as of this morning, we are just two patients away from completing enrollment of our pivotal meta study in brain metastases from non-small cell lung cancer. 2022 was a year of solid execution that will shape the future of our company. And our teams are excited and motivated for all that awaits us in 2023. We will begin today's call with a discussion of our GBM business. We will then review our clinical pipeline and near-term milestones. Finally, we will review our financial performance in the fourth quarter of 2022 before opening the line for questions. Our commercial business treating newly diagnosed GBM patients provides a solid foundation for growth. We have gained essential knowledge, built critical infrastructure, and established the financial strength to support future launches and new indications. In 2022, we generated over half a billion dollars in net revenue and ended the year with 3,430 active patients on therapy. The GBM business is strong and sustainable, with penetration rates ranging from 30% to 40% in our key markets. but we know that there are many more GBM patients that can benefit from TT Field Therapy. As such, we remain focused on engagement and education of healthcare providers, patients, and caregivers. Last year, we reorganized our GBM team, bringing sales, marketing, and medical leadership under one umbrella with the intention to streamline decision-making and improve coordination with the goal of renewing growth in our CNS business. We are also focused on driving greater awareness of Optune among patients. Seven years since FDA approval in newly diagnosed GBM, some providers still see TT Fields as a new and experimental therapy. We want to ensure patients are aware of the benefits of Optune and are fully equipped to advocate for TT Fields treatment in appropriate situations. To this end, we have bolstered our patient-focused marketing efforts and are pursuing greater awareness across a variety of traditional and new media channels, including social media. We believe our educational efforts with providers and patients, as well as our streamlined commercial structure, will provide the foundation to return to growth in the coming years and provide a blueprint for commercial launches and other indications. Published data and real-world evidence are paramount when working to change the standard of care and shift physician practice. In 2022, we saw a bevy of real-world evidence publications supporting the use of TT fields. These studies have included large populations, such as Dr. Corey Neff of Duke University's review of central brain tumor registry and IQVIA treatment data from 2015 through 2021, spanning 19,000 patients in the U.S. treated for GBM. Others have analyzed long periods at a single center, such as the study from Nahumulka Hospital in Prague, which tracked GBM patients treated with TT fields over 18 years. We have also seen multiple real-world evidence studies from our key Asian markets. A recent review in Frontiers in Oncology by Dr. Zhu Du of North Sichuan Medical College found that the average growth rate for publications related to TT fields was 29% and stated that studying the therapeutic potential of TT fields has become a research hotspot. The common theme of these publications has been the validation and in many cases improvement over the results of our pivotal EF14 clinical study. The real-world studies contribute to the opus of clinical evidence supporting the use of TT fields and will be crucial to our efforts to drive greater adoption. I would like to close today with a discussion of the positive top-line results from our pivotal lunar study. As a reminder, LUNR was designed to evaluate the use of PT fields together with either immune checkpoint inhibitors or docetaxel for the treatment of stage 4 non-small cell lung cancer following first-line progression with a regimen including platinum-based chemotherapy. In January, we announced LUNR met its primary endpoints. demonstrating a statistically significant and clinically meaningful extension in overall survival for patients treated with TT fields together with standard therapies. Further, we saw a statistically significant and clinically meaningful extension in overall survival for patients treated with TT fields and immune checkpoint inhibitors versus immune checkpoint inhibitors alone. and a positive trend in overall survival for patients treated with TT fields and docetaxel versus docetaxel alone. We believe these data represent a crucial finding for patients diagnosed with stage 4 non-small cell lung cancer. In the U.S., 46,000 non-small cell lung cancer patients seek treatment in the second line each year, as do thousands more around the world. Since pembrolizumab was approved in this setting in 2016, there has been little progress in extending survival for these patients. We believe the lunar data have the potential to transform the treatment paradigm for these patients and more generally point to the future of solid tumor therapy. Our team continues to analyze the data in preparation for a full presentation and publication and we look forward to sharing the data with physicians, patients, and investors later this year. With that, I will now turn to Asaf to discuss other updates in our clinical and product development efforts.
spk11: Thank you, Bill. I would like to echo Bill's excitement about the positive top-line readout of the Lunar study. Lunar is a key achievement for NovoQ. Lunar is our first pivotal study completed with immunotherapies and our first pivotal study treating solid tumors outside of the brain. It is also the first of four pivotal studies which we expect to read out in the coming two years, which, if successful, will transform our company. I began my career at NovoQ in 2002, more than 21 years ago, and I can attest that I have never felt more engaged or excited. Our employees have worked so hard And I'm so eager for what awaits us. At an upcoming medical congress, we will present the full lunar data set. In summer and fall, we expect to release the top line and full results of the INNOVA3 pivotal study in ovarian cancer. Early next year, we anticipate top line data from the METI study. Shortly thereafter, we expect to announce the Panova3 top line readout. And at about the same time, we anticipate commercial launches in non-small cell lung cancer and ovarian cancer, with more to come in 2025 and beyond. This is an incredible time to be at NovoQ. I would be remiss to not mention the team's recent achievement launching our next generation array in select European markets. Our new arrays are thinner, lighter, and more flexible than previous versions. They can also optimize the intensity of TT fields delivered to the tumor without a material increase in heat delivered to the scalp. Preclinical research has shown that increased intensity delivered to a patient's tumor bed can potentially increase the efficacy of TT fields therapy without an increase in systemic toxicity. We are utilizing this limited release to study patient use patterns with the new arrays. The data gathered will inform future launch plans in additional markets. After the successful launch in Austria, we are preparing to expand the program to Sweden. Our new arrays are the first of what we expect to be a long line of product enhancements designed to optimize TT fields therapy. Before handing the call to Ashley, I would like to thank my colleagues at NovoQ for a successful 2022. Through your hard work, We have positioned ourselves to take advantage of immense opportunity in the coming years. I know you will all rise to the occasion, as you have many times in the past. I will now turn the call over to Ashley to review our fourth quarter financials.
spk08: Thank you, Asaf. Novocare finished the year in a strong financial position and primed for growth in the coming years. In 2022, our GBM business generated $538 million in net revenues and $31 million in net cash from operations. Our durable commercial business is fueling research and development and enables us to invest aggressively in preparation for new product launches and new market entries. In the fourth quarter specifically, we generated $128 million in net revenues. We are pleased to report that, as expected, our EMEA revenues are starting to return to prior levels as the average net revenue per active patient month in Germany begins to recover. As a reminder, we expect this to be a gradual process that plays out for multiple quarters to come. Collections from aged claims were lower in the fourth quarter compared to prior periods. For the full year, we reported $32 million in revenue from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries billed prior to established coverage. We will continue to actively appeal and pursue previously denied claims for beneficiaries billed prior to established coverage, but the cadence and amount of these Medicare payments are impossible to predict. We believe collections from those claims which were most accessible were largely exhausted in 2022, and the remaining outstanding claims will take time to collect. To reiterate from last quarter, in 2023, we expect net revenues to closely reflect the core drivers of our GVM business. Active patients on therapy times net revenue per active patient per month times 12 months. Growth margin for the fourth quarter was 78%, in line with our margin from the same period last year. SG&A expenses in the quarter were $88 million, an increase of 25% year-over-year. This increase reflects an investment in pre-commercial activities intended to build a strong foundation ahead of potential future indications. We are also investing aggressively in market access resources to identify and enter new markets in the coming years. Research and development expenses in the quarter totaled $55 million, with $206 million invested for the full year. As the current slate of pivotal clinical studies nears conclusion, we plan to continue investing to explore the use of PP fields in new indications, evaluate opportunities to expand labels in our approved indications, and to study potential additive effects with novel standards of care. Additionally, we continue to invest aggressively in product development efforts designed to optimize our therapies and patient quality of life. Our net loss for the fourth quarter was $0.36 per share, or $37 million, and adjusted EBITDA was a negative $10 million. Cash and short-term investments totaled $969 million as of December 31, 2022. With a multitude of near-term catalysts and many growth opportunities on the horizon, We are focused on investing to realize the full capability and applicability of our therapy. We believe these investments will drive long-term value for Novacure and enable us to treat many more patients in the future. I'd like to close today by highlighting one of our Optune users. Since she was a child, Linda Long dreamed of being a Philadelphia firefighter. She chased that dream and became the city's first female battalion chief in 2017. Linda was diagnosed with GBM in March 2021. After undergoing debulking surgery at Penn Medicine, she began chemotherapy and radiation treatment. Two dozen of her fellow firefighters took turns driving her to and from treatment sessions and paying her home visits. Her neighbors grew accustomed to seeing fire trucks parked outside of her home. Linda also began using options. In the almost two years since her diagnosis, Linda's disease has not progressed. While using TT Fields, she goes on daily walks in the city park and makes jewelry out of stones and other objects she finds and picks up along the way. Last year, she participated in the National Brain Tumor Society's Race for Hope. Linda and her fellow firefighters helped raise $15,000. People like Linda are a daily reminder of why we are here and the impact we can make. as we strive to extend survival in some of the most aggressive forms of cancer. With that, I will turn it back to the operator for questions.
spk10: Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.
spk09: Please stand by while we compile our Q&A roster.
spk10: Our first question comes from the line of Nansan with JPM Chase. Your line is open. Please go ahead.
spk07: Hey, guys. Can you hear me?
spk01: We can hear you. Good morning.
spk07: Good morning. Hi. I'm calling in for Jessica Tsai. So one of the questions we were thinking about, and congratulations on the lunar data, is that how do you think the KOLs, when they actually see the data presentation, will actually apply the data to their patients? Specifically, do you think they will limit the use of Optune in patients who progressed on platinum or expand it to patients who are also treated with checkpoint inhibitors in the first line? And then the second question, more in general, Can we think about, how do we think about the timing for ovarian top line and what the data set will mean for NovoCure? Thank you.
spk01: Okay, so maybe I'll start with the first question and then I'll turn the second question over to Pritesh Shah to talk about ovarian. But first of all, thank you very much for your congratulations for the lunar top line. As Asaf mentioned during the prepared remarks, we couldn't be more excited and energized. And everyone in the company is sort of heads down preparing, whether they're in the regulatory group or whether they're in the commercial group, for the release of the data and then all the steps that are required to bring that therapy to patients. With respect to your specific question, the trial was designed to treat patients after platinum failure, and we expect that to be the label, and I will say the first label. But as you allude to, the data, as we said, are profound when TT fields are combined with checkpoint inhibitors, and we think that does point in the direction of future clinical research to really bring that combination to patients in a variety of cancers in a variety of lines. And we're already planning the next clinical trials in non-small cell lung cancer. So non-small cell lung cancer is not what we call a one trial and done indication. It's a very large indication. And we would expect to continue to explore the combination of TT fields and immunotherapies in other lines and in other combinations so that doctors can prescribe it to all patients. With that, Pritesh, maybe you can talk a little bit about ovarian.
spk03: Yes, thank you, Bill. And I'll remind everybody about the INOVATE-3 study, which is our ovarian cancer study. We were very excited to announce that last patient was enrolled in Q4 of 2021. Again, as a reminder, there's an 18-month follow-up that's ongoing on the study, and we expect top line, as you heard in the prepared remarks, in the summer timeframe. So we remain excited to get to the data. Once we have the data, we will work with the ovarian cancer community to learn from their perspective on clinical implications. So more to come on this front. and we remain very enthusiastic about helping the ovarian cancer community.
spk09: Thank you. We'll move on to our next question.
spk10: Our next question comes from the line of Jason Witts with Loop Capital. Your line is open. Please go ahead.
spk00: Hi, thanks for taking the questions and congratulations on the Lunar top line data. First off, in terms of, is there an ETA or an expectation of when we will see the full Lunar data?
spk01: Yeah, again, just for everyone's, I know most of you are aware of this. When we or any other company conducts a major clinical trial with market moving implications, We announce the success or failure as quickly as we know in a press release, but we don't publish the specific data because that risks the ability to present at a future medical conference and to publish in a top-tier journal. So that's the reason for this gap. We are eager to get the data to all the constituencies, and so we're in the process of both preparing the publication and submitting the abstract for presentation at an upcoming medical conference. As soon as that's accepted, we'll let you know exactly when and where, but you can expect it later this year.
spk00: Okay, thank you for that. And has there been any reaction from the field in terms of enrollment in trials or even GBM users? post-Lunar announcement in terms of just general reaction to be curious to know what you've heard from the field on that.
spk01: Yeah, so it's tremendously exciting. You know, again, there hasn't been any progress in this particular group of non-small cell lung cancer patients since the original immunocheckpoint inhibitor trials six years ago. So notwithstanding everything that we all read about the progress being made in multiple fronts in cancer, this has been another stubborn, difficult-to-treat cohort. So I think it's exciting, and I think the communities understand that this is the same physics that we're applying to a different region of the body, and so it underlines the ability of tumor treating fields to fight difficult to treat solid tumors and is sort of mutually reinforcing of all of our efforts.
spk00: Okay, great. I'll jump back into you. Thank you very much.
spk10: Thank you.
spk09: And one moment for our next question. And our next question comes from the line of Lee Hong with Wells Fargo. Your line is open. Please go ahead. Hi. Can you hear me? You can.
spk01: Good morning.
spk08: Good morning. Thanks for taking my question. It's at . Just a couple on lunar, please. Can you talk about your confidence level that the active and control arms in the study were balanced in terms of patient characteristics and first-line therapy?
spk01: Sure. To remind everyone, this is a randomized study, and we've said that the control groups behaved as expected and that the arms were well-balanced in terms of numbers. And we look forward to sharing all the details with you as I said, later in the summer. But all the indications, as we announced in the press release, show balance. And as I said, I'll just say it again, appropriate and expected results in the control arms.
spk08: Got it. Okay. And then in today's press release, you mentioned that Lunar met a key secondary endpoint on overall survival. So you confirmed that the study hit on in the IOR. It missed on docetaxel, but that was a positive trend. So does that mean the third endpoint on overall survival in terms of TT fields plus docetaxel against IO alone, that endpoint was missed?
spk01: Again, you know, I think there's nothing new. other than what was announced in the press release. And again, let me just say how excited we are about this. So we hit in the primary endpoint, which was all patients treated with tumor treating fields plus standard therapy compared to all patients treated with either docetaxel or immune checkpoint inhibitors combined. And we had a statistically significant and clinically meaningful improvement in that total group. And then as you stated in the second line, the power at secondary endpoints, excuse me, we saw statistically significant and profound improvement in the patients treated with immune checkpoint inhibitors plus TT fields compared to immune checkpoint inhibitors alone. And a positive trend, but not statistical significance in the patients treated with tumor treating fields plus docetaxel compared to docetaxel alone.
spk08: Just to be clear, you're not commenting specifically on the third and secondary endpoint having to do with overall survival. You're not commenting on that?
spk01: No, that will come later this year.
spk08: Fair enough. If I can squeeze in one more for Ashley, please. Your revenue was down slightly in 2022 and that included some of the backlog collection. Directionally, can you just talk about If you expect revenue to grow in 23, if you exclude that backlog collection, I understand that, you know, that was a little hanging fruit last year. That may be tougher this year. But if we just exclude that 32 million from 2022, do you see your revenue growing in 23? Thank you. Yeah, Leigh, thanks for the question and the opportunity to reiterate this message because it is extremely important for everybody to understand in your modeling. So you have the right numbers. We did confirm that we recorded $32 million in Medicare from aged claims. So these are claims that were billed for patients that started prior to established coverage in the US. As you noted, and again, I will just reiterate, we continue to actively appeal and pursue these claims, but the collections that are most accessible were largely exhausted and the remaining outstanding claims will take time to collect. So we would not recommend you consider contribution from age claims in your forward-looking model. So remove that $32 million when you look at the baseline for 2023. And then as we look forward, net revenue should more closely reflect the core drivers of our GBM business, which are active patient growth, times net revenue per active patient per month, times months on therapy. So active patient growth should drive revenue growth as we look forward.
spk09: Thank you, and one moment for our next question.
spk10: Our next question comes from the line of Jason Bender with Piper Sandler, your line is open. Please go ahead.
spk04: Hey, good morning, everyone. Thanks for taking the questions. Great to see all the progress here in closing up enrollment on your Phase III programs. Actually, a little surprised we haven't gotten a question yet on MEDIS. But look, I know some of these are still in process and waiting on sufficient patient follow-up for a few of them. But maybe what's the right way to think about back-selling this pipeline? You know, in short order, we've gone from four phase three studies enrolling to potentially none here in a matter of days. You're just from today. How are you thinking about formally adding to the later stage pipeline? And has the recent experience of, you know, tumor treating fields plus chemo and a few recent studies, you know, Hepanova, the gastric cancer trial, and then Lunar here just recently, has that at all changed how you're planning to approach future trials with tumor treating fields?
spk11: So, thank you very much for this question. We are, you know, our original trial was basically we used a TT field, you know, in comparing to standard of care. And our future trial is to combine TT field with some experimental drugs. So, this is basically put us in totally different regulatory area which was different than what we used to have. So I do want to mention that we are excited and planning to run additional phase three trials in all the indications that you just mentioned and more. And the regulatory challenge is higher, and the fact that we are combining two experimental therapies make it a little bit more challenging. But we are all in and looking forward for the next slide.
spk04: Maybe just a quick follow-up on that before my other question. Should we expect additional Phase 3s to start within this calendar year? Absolutely. Okay. All right. And then maybe coming back to Ashley, and apologies in advance for a lengthy question, but I do want to follow up on Leigh's question there just prior to this one. On 2023 revenue, when I think back to last year, we had that active patient guidance. I don't think we have that here for 23, but that was very helpful in using to accurately forecast revenue. This year, predicting revenue is a little bit different. We had the situation in Germany that's affected modeling around revenue per active patient. You've communicated the whole situation on past Medicare claims. But you also have Medicare revenue per patient that's rising, I think, 9% here to start 2023. You have France that should be kicking in here any day now. And then I think you also have some international expansion with recently opened offices in Canada and Spain. So I guess with all of that in mind, just wondering if you could comment on whether you're comfortable with the street modeling year-over-year revenue growth for this year.
spk08: Yeah, Jason, again, appreciate the opportunity to just reiterate. I want to make sure that the top line message that everyone hears is that they do need to remove the impact of these age claims so that you're starting off with a clean base, right? That is very critical as it is a key contributor of the number in 2022. But then when you point to the growth factors in 2023, you're focusing on the right things. We have continued penetration in our active markets as we continue to believe there's opportunity to access more patients in newly diagnosed GBM in large markets like the U.S., Germany, and Japan. We have geographical expansion in 2023. In terms of revenue, that will primarily be France, because as we look to some of the other markets, we're doing important building efforts there, but it will take time to drive material revenue. So I would focus on France coming online in the beginning of this year and then see it begin to contribute to revenue towards the back half of this year as we gain experience with those payer collection patterns. And then, you know, Germany should recover. We've talked about this, that that was a short-term pain in 2022 for long-term gain. It will take through the end of the year to recover, but you can kind of look at that arc over the course of 2022 and expect it to begin to recover. So I think, you know, those are the puts and takes. And when we look at the core fundamental drivers, it's going to be make an expectation about active patient growth and then expect expect net revenue to be stable, you know, without the impact of DH claims for Medicare.
spk04: Okay. Can Germany grow this year, Ashley?
spk08: Certainly. Yeah, I mean, both, I would say, on a base business activation, but also in a recovery price. Yes. Okay.
spk09: Thank you.
spk10: Thank you. And one moment for our next question. Our next question comes from the line of Greg Frazier with Truist. Your line is open. Please go ahead.
spk12: Good morning, folks. Thanks for taking the questions. I was wondering if you could comment on how the FlexArray launch is going. I know it's early and focused, but maybe you can comment on how that launch is going so far and how to think about the expansion to the rest of Europe. And then on France, investors think about the potential ramp there and appreciate the comments that you just made, Ashley, but would it be fair to look back at the experience in Germany as a precedent for what uptake could look like in France over time? Thanks so much.
spk11: So, thank you. This is a great question that I actually was looking forward to this kind of question. The FlexArray and the new arrays is something that, you know, not happen, you know, every year in OverQ. It's happened I think our new array is something that we're very proud about it, and the launch in Austria, we're treating a few dozen of patients, and so far the results are great. We're still waiting to see long-term results, but so far we're very, very pleased with the launch. And we are going to move to Sweden and other countries after that. I would say that it's according to our plans and we feel very comfortable with that.
spk08: And Greg, I'll just jump in on France. You're not gonna have to look at a proxy market. We can look at the actual active patient development itself. So you'll start to see active patients come online and then I would expect to see revenue recognized for those active patients to lag a couple of quarters as we look to the collection cycle of payers. So my recommendation would be to actually look at the experience and the results of active patient growth in the front half of the year and once you see that trajectory, use that to model the revenue towards the back half of the year.
spk10: Thank you. And our next question comes from the line of Vijay Kumar with Evercore ISI. Your line is open. Please go ahead.
spk02: Hey, guys. Thanks for taking my question. On this lunar trial, Bill, I think you mentioned it's randomized. It's well-balanced. Do we know the PD-1 status of the patients in the treatment and control arm, mutation profile, and Was that known for all patients or only some percentage of patients enrolled in the trial?
spk01: So again, Vijay, the answers to the questions you just asked and the other questions being asked about the specifics of the cohorts will be answered later this year at the medical conference.
spk02: Understood. And then maybe one more on the statistical plan for this study. I think... The original power of the study was 80% power. I guess with the sample size being cut, is this study now a power to detect the secondary endpoints and the overall survival endpoint? I'm curious what's happened in the powering of the study.
spk01: Yeah, so there was no change to the powering of the study. And so the lunar study remains powered to detect overall survival in the primary and in the two powered secondaries.
spk02: Understood. Then maybe, Ashley, one for you here. Revenues, XCMS, if I understood, XCMS, are you guiding to revenues being up year on year? And what is this CMS headwind in fiscal 22?
spk08: Yeah, so again, as a reminder, we recorded $32 million in revenue from aged claims in 2022. So that relates to cash that we collected on Medicare patients that were billed prior to established coverage in 2019. So aged claims from prior to the establishment of this coverage. We continue to appeal and pursue those claims, and we'll continue to recognize and take that cash onto the balance sheet as we collect it, but it does not relate to the core business of today. And so our recommendation as you look forward is to model revenue growth in line with active patient growth. Active patient growth will be the core driver of our revenue growth as we look forward to 2023-2024. and beyond, given the fact that the most accessible age Medicare claims have been captured on the balance sheet.
spk02: And that $32 million, Ashley, how did that flow through? What was the cadence? I think maybe half of that came in 2Q. What was it in 3Q and 4Q?
spk08: Yeah, I mean, if you just look at the top line, BJ, you can see how that cadence has gone through the year. When you look at active patient growth and you see net revenue growth on top of that acceleration, you can attribute that to the aged claims.
spk02: All right. Thanks, guys.
spk10: Thank you. And one moment for our next question. And our next question comes from the line of Emily Bundner with HC Wainwright. Your line is open. Please go ahead.
spk05: Hi, thanks for taking the questions. I'm curious with the Innovate3 study reading out soon, if that was positive, can you maybe discuss launch plans for having to launch in non-small cell lung cancer and ovarian cancers in a fairly close timeframe? Is some of that launch work like overlapping or how do those kind of differ from each other? And then maybe any enrollment updates on the keynote B36 study and first-line lung and when we may see some data on that study. Thanks.
spk01: Yes, so you may recall that during the year, we reorganized at Novacure to really accomplish two things. First, to combine and focus all the efforts on our core GBM business, and then separate and combine and focus all the efforts to launch the new indications. Pritesh is responsible for that second group of activities. So, Tesh, maybe you can comment on the activities required to launch in multiple indications.
spk03: Yes, thank you, Bill, and thank you for the question, Emily. So, first of all, we would welcome that opportunity because it would be very exciting for us to bring TT Fields therapy to multiple patient populations that can benefit from our therapy. I would say because of the platform nature of our therapy, it allows us to generate awareness among the medical oncology community. So we're not having to educate on mechanism of action separately or the way that our therapy works separately. Given that and the fact that it'll be primarily the medical oncology community, the work that we're doing for Luna will parlay into the work that we will have to do for other indications. And this really becomes a benefit for us as we transcend from primarily a GBM business to a pan tumor franchise. And as you would expect, we're doing the same level of preparation that you would do in a launch opportunity, which is first and foremost, once the data set is available, we'll look to understand clinical implications of the data. We will look to see how to position our therapy in the context of what's happening in the clinic And then we will look forward to the commercial planning, which would include build out of our sales organization, training, and finally getting to the FDA approval, which would allow us to then promote and market our therapy. So lots of good things happening on this front. And we're already started on this journey with Lunar. And as the other indications come into focus, we will continue to double down on those opportunities.
spk01: And with respect to your question on Keynote B36, just to remind everybody that Keynote B36 is a trial, it's a pilot trial that we're undertaking in partnership with Merck, combining tumor treating fields plus Keytruda in the first line in non-small cell lung cancer. Enrollment is ongoing, and as has been always the case, we don't report ongoing enrollment numbers, but there's... There's really no news. It's going as planned and we'll report when we have last patient in.
spk10: Thank you. And I'm showing no further questions at this time. And I would like to hand the conference back over to William Doyle for any further remarks.
spk01: So I'd just like to echo what Asaf said in the prepared remarks that This couldn't be more exciting a time to be working at NovoCure. We're on the threshold of bringing our therapy from patients with GBM to many more patients with many other extremely difficult to treat solid tumors. 2022 was a year of consistent and really exceptional execution at NovoCure. and is laying the strong foundation for this exciting period to come. With four pivotal trials set to read out in the next 24 months, we're absolutely in this transformational period, and we look forward to updating you on our progress throughout the year. And I'll end also echoing Asaf and just thanking everybody at NovoCure for their hard work last year, and it's Seems almost strange to be talking about 2022 at this point because we're so firmly into 2023, but also thank you for all your efforts so far and going forward.
spk10: This concludes today's conference call. Thank you for participating. You may now disconnect.
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