NASDAQ:NVCR NovoCure Q3 2024 Earnings Report $15.58 -0.25 (-1.58%) Closing price 04/17/2025 04:00 PM EasternExtended Trading$15.57 -0.01 (-0.06%) As of 04/17/2025 04:33 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast NovoCure EPS ResultsActual EPS-$0.28Consensus EPS -$0.34Beat/MissBeat by +$0.06One Year Ago EPS-$0.46NovoCure Revenue ResultsActual Revenue$155.10 millionExpected Revenue$143.95 millionBeat/MissBeat by +$11.15 millionYoY Revenue Growth+21.80%NovoCure Announcement DetailsQuarterQ3 2024Date10/30/2024TimeBefore Market OpensConference Call DateWednesday, October 30, 2024Conference Call Time8:00AM ETUpcoming EarningsNovoCure's Q1 2025 earnings is scheduled for Thursday, April 24, 2025, with a conference call scheduled at 8:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)SEC FilingEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by NovoCure Q3 2024 Earnings Call TranscriptProvided by QuartrOctober 30, 2024 ShareLink copied to clipboard.There are 14 speakers on the call. Operator00:00:00Good day and thank you for standing by. Welcome to the Novicore Q3 2024 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. Operator00:00:33I would now like to hand the conference over to your speaker today, Ingrid Goldberg. Please go ahead. Speaker 100:00:42Good morning, and thank you for joining us to review Novocure's Q3 2024 performance. I'm on the phone this morning with our Executive Chairman, Bill Doyle our CEO, Asaf Dhanbiger and our CFO, Ashley Cordova. Other members of our executive leadership team will be available for Q and A. For your reference, slides accompanying this earnings release can be found on our website, www.novacare.com, on the Investor Relations page under Quarterly Reports. Before we start, I would like to remind you that our discussions during this conference call will include forward looking statements and actual results could differ materially from those projected in these statements. Speaker 100:01:21These 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. Speaker 200:01:28We do Speaker 100:01:28not 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 best reflects the financial value generated by our business. Reconciliations of non GAAP to GAAP financial measures are included in our press release, earnings slides and in our Form 8 ks filed with the SEC today. These materials can also be accessed from the Investor Relations page of our website. Speaker 100:02:10Following 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, and good morning. Speaker 300:02:19At Novocure, our mission is to extend survivals in some of the most aggressive forms of cancer. Our efforts have focused largely on glioblastoma, but with the recent approval of OptuneLA for non small cell lung cancer, we are launching our next large indication. Launching Tumor Treating Fields therapy in non small cell lung cancer is an important achievement for NovoCure. We are eager to bring a new and urgently needed therapeutic option to patients in need. This morning, we will begin with a discussion of our non small cell lung cancer approval and launch plans, followed by a GBM business review, clinical pipeline update and review of Novocure's Q3 financial performance. Speaker 300:03:072 weeks ago, the FDA approved our PMA for OptuneLA to treat post platinum metastatic non small cell lung cancer together with either an immune checkpoint inhibitor or docetaxel. As you know, TT field therapy is already approved to treat glioblastoma and mesothelioma, rare forms of brain and thoracic cancer. Our approval to treat non small cell lung cancer means our innovative therapy will be an option for a large and growing patient population with an urgent and unmet need for effective therapies in the 2nd line. For months, we have been preparing for this launch. The lung team was hired over the summer and has undergone extensive scientific training. Speaker 300:03:54We have had a substantial presence at oncology congresses around the world, including ELCC, ASCO, WCLC and ESMO, providing an opportunity for physicians to learn about TT field therapy. We have had numerous advisory boards to ensure we fully understand the physician and patient needs. Our marketing team is prepared with a suite of resources for providers, care teams, patients and caregivers. Physician and patient focused websites were launched the day after approval and our sales team was fully trained and in the field the following Monday. We are pleased to report that our first round of physicians have completed certification and we received our first lung prescription shortly after approval. Speaker 300:04:45Our launch is well underway. We are also preparing for launch in Germany and Japan in anticipation of regulatory approvals. As noted last quarter, the new MDR process has lengthened regulatory review timelines in Europe. While the review process has taken longer than originally projected, we remain hopeful for a final decision in the coming months. In Japan, we have submitted our application to the PMDA and productive conversations are ongoing. Speaker 300:05:15We will be launch ready upon approval in both of these important markets. I am incredibly proud of the efforts of our team to bring TTFields therapy to non small cell lung cancer patients. So many people across Novocure have contributed to this milestone. Also, we would not have been able to celebrate this moment today without the partnership and commitment of our patients, their families and caregivers and the physicians, researchers and healthcare professionals that have taken part in our clinical trials. Thank you all. Speaker 300:05:48This is an important achievement for patients. As we prepare for a new chapter at Novocure, we are pleased to implement planned changes to our executive team that will position Novocure for long term success. Last month, we announced the retirement at the end of this year of our CEO, Assaf Donsinger. Assaf has been with Novocure for 22 years and has shepherded our company through our successful clinical trials, regulatory approvals, engineering advances and the launch of our successful GBM business. Under Assaf's leadership, we have grown from a small team in Israel to an international company of over 1400 employees. Speaker 300:06:32We knew the day would come when Asaf would choose to retire and to prepare, we have been cultivating a strong bench of leaders. When the Board began the process to identify Asaf successor, our goal was to find a candidate with substantial institutional knowledge, experience managing and expanding global organization and a deep understanding of our clinical and commercial opportunities. Ashley Cordova embodies all of these characteristics. Ashley has been integral to scaling NovoCure's global operations and infrastructure since joining the company in 2014. Her commitment to our patients and strategic vision are exceptional as is her record of accomplishment as our CFO. Speaker 300:07:18We are delighted Ashley has accepted the challenge and confident she is the right choice to drive NovoCure's next stage of growth. This morning, we also announced Christophe Brackmann has joined Novocure as our next CFO, replacing Ashley in this role. Christophe joins Novocure this week and will assume the CFO position on January 1. Christophe was most recently the Senior Vice President of Finance at Moderna and he brings a wealth of experience in the biotechnology and pharmaceutical industries. Christophe was instrumental to Moderna's scale up during the COVID pandemic. Speaker 300:07:56His external perspective will be an important addition to our executive team. Finally, in October, Mukun Paravashu took over as our COO, following the retirement of Wilco Grundhuysen. With these additions to our executive leadership, the Board and I believe we have the team in place that will lead Novocure to the next levels of growth. Before I pass the call over to Ashley, I would like to extend my personal thanks to Asaf for his 22 years of dedication to Novocure. Asaf and I were young men when we embarked on the journey to bring Tumor Treating Fields Therapy to patients, and I know we would not have succeeded and Novocure would not exist today without Asahi. Speaker 300:08:46Ashley? Speaker 400:08:48Thank you, Bill. It is an exciting time to be at Novocure and I am both humbled and energized by the opportunity to lead this company into a bright future. Throughout 2024, we have taken steps to return our GBM business to growth through a focus on prescription conversion, patient persistence and cross functional alignment. This quarter, we saw the fruits of these initiatives across all major markets with global active patient growth of 13% year over year. We ended the quarter with a record 4,113 active patient blood therapy, breaking the 4,000 patient threshold for the first time. Speaker 400:09:32This helped us deliver 22% year over year top line growth. We have also seen substantial progress across our clinical programs. Our next clinical milestone will be top line data from our Phase 3 PANOVA trial later this year. PANOVA 3 is studying the use of tumor treating field therapy with gemcitabine and nab paclitaxel for the treatment of unresectable locally advanced pancreatic cancer. We recently completed patient follow-up and are now finalizing data collection and analyses. Speaker 400:10:09This quarter, we also completed enrollment in our Phase 2 PANOVA 4 trial, which adds Roche's immune check point inhibitor atezolizumab to tumor treating field therapy gemcitabine and nab paclitaxel for the treatment of metastatic pancreatic cancer. As a reminder, PENOVA-four was launched in mid-twenty 23, just 5 quarters ago and was designed to enroll 76 patients. We are pleased with the excitement and engagement of the pancreatic cancer community around this trial and are eager to better understand the potential of tumor treating field therapy in this setting. Our next indication to be submitted to the FDA for PMA review will be the treatment of brain metastases for non small cell lung cancer. As a reminder, we presented data from the Phase 3 METIS trial at ASCO in June. Speaker 400:11:01METIS met its primary endpoint, demonstrating a median time to intracranial progression of 21.9 months for patients using tumor treating field therapy compared to 11.3 months for patients randomized to the control. Importantly, the META status showed patients treated with tumor treating fields maintained quality of life and cognitive function, key challenges in the treatment of brain metastases. We are pleased to announce today that the FDA has granted breakthrough device designation for the use of tumor treating field therapy for brain metastases from non small cell lung cancer. Breakthrough device designation gives us more frequent, faster and interactive access to the FDA review team and senior management during the review process, priority review of our marketing application upon filing, and expedited review of pre PMA manufacturing and quality systems compliance inspection. We expect to file the PMA in early 2025. Speaker 400:12:08Following on the success of the LUNAR trial in metastatic non small cell lung cancer are our Phase 3 LUNAR II and Phase 2 LUNAR IV trials. LUNAR II is studying tumor treating fields together with platinum chemotherapy and pembrolizumab in the first line. LUNAR-four is setting treatment with tumor treating field therapy and pembrolizumab in the second line following first line treatment with a checkpoint inhibitor and platinum based chemotherapy. Both are open and actively enrolling patients and important to our ongoing efforts to establish and increase adoption of tumor treating field therapy in non small cell lung. We also have 2 ongoing Phase 3 trials in GBM, TRIDENT and KEYNOTE-fifty eight. Speaker 400:12:56The TRIDENT trial is studying the benefit of starting Optune GEO earlier in the patient journey concurrent with chemoradiation rather than following chemoradiation. Trident completed enrollment last January and patients are currently in the 2 year follow-up period, with data expected in 2026. We are initiating sites for the KEYNOTE-fifty eight trial, studying the addition of pembrolizumab to the current GBM standard of care, Optune GEO plus temozolomide following chemoradiation. KEYNOTE-fifty eight is an exciting opportunity to build upon the results of the Phase 2 TO THE TOP trial and study the benefits of using tumor treating field therapy with immune checkpoint inhibitors in newly diagnosed GBM. Turning to our financial performance for the Q3, top line growth was strong. Speaker 400:13:54Q3 net revenues were $155,000,000 an increase of 22% from the same period last year. The increase was largely driven by active patient growth in our key markets and improved approval rates in the United States. The improved U. S. Approval rates contributed $5,000,000 in Q3 net revenues from prior period billings. Speaker 400:14:18Looking ahead, we do not expect to see an incremental one time benefit from prior periods as the improved approval rates are now considered in our baseline revenue run rate. Gross margin in the Q3 was 77% compared to 75% in the Q3 of 2023. This improvement was driven by a higher net revenue per patient due to the increase in U. S. Approval rates and our strong performance in France. Speaker 400:14:48Looking ahead, we expect the global launch of our next generation arrays as a non small cell lung cancer indication to be headwinds to gross margin. SG and A expenses were $100,000,000 in the 3rd quarter, in line with Q3 2023. Our sales and marketing expenses increased year over year in support of our lung cancer launch, offset by lower personnel costs and G and A. Research and development expenses in the quarter totaled $52,000,000 a decrease of 3% from the same period in 2023. Our net loss for the quarter was $31,000,000 or $0.28 per share. Speaker 400:15:29Adjusted EBITDA was $2,000,000 an increase of $31,000,000 compared to the same period last year and our 2nd quarter in a row with positive adjusted EBITDA. This was largely driven by the increase in net revenues as well as material benefits from reduced operating expenses resulting from the strategic restructuring we undertook at the end of 2023. As we continue to invest in growth, profitability remains an important goal and something we are actively driving towards. As Bill noted earlier, Asaf will be retiring at the end of the year. So this will be his final earnings call. Speaker 400:16:12I would like to personally thank Asaf for his friendship and leadership over the past 10 years and will now turn the call over to him for some parting words. Speaker 500:16:22Thank you, Ashley. When I joined Professor Palti, NovoCure was a company of a few people in a preclinical lab, working to bring TT Fields therapy to the fight against cancer. Today, NovoCure is a team of more than 1400 and is treating thousands of cancer patients across the globe. I'm very proud of how far we have come and of the lives we have affected. And I know NovoCure is poised for greater things ahead under Ashley's leadership. Speaker 500:16:57We have worked together for more than a decade, so I know Ashley has the passion and tenacity needed to take NovoCube to the next level. Ashley has been integral to NovoCube's evolution from small company to global organization and for ensuring we have had the financial structure and strength to support our growth. There is no one better to lead us into the future. I would like to thank all my colleagues for an incredible journey. Your dedication to our patients is an inspiration, and I know your commitment to our patient centric mission will continue to guide your work at NovoCure. Speaker 500:17:40Finally, I would like to thank our patients, their families and caregivers, physicians and care teams for putting your faith in us. Our mission has always been personal to me and something I take extremely seriously. There is nothing more sacred than giving someone more time with the people they love, and I will always be grateful for the opportunity to contribute to each and every patient's journey. Thank you. I will now hand the call back to the operator. Speaker 400:18:15Thank you. Operator00:18:35And our first question comes from Larry Biegelsen of Wells Fargo. Your line is open. Speaker 600:18:43Hi, good morning. It's Lyric Lei calling in for Larry. Can you hear me okay? Speaker 700:18:49Good. Speaker 600:18:52First, a softest congratulations on your retirement. Well deserved. As far as questions, just on LUNAR, what are you saying about the revenue per patient for OptumLula? And as far as treatment duration, should we think about kind of the 4 to 5 months average? And along with that, what are you expecting on timing for Japan approval? Speaker 600:19:18And I have a follow-up. Speaker 200:19:22This is Ashley. I'll jump in just quickly with the first question. We would expect the pricing to be in line with the afternoon to you pricing. And you are right, that's a 4 to 5 months is what I would model. That's what we saw in the clinical trial. Speaker 200:19:34And until we have more commercial experience, that's what we would incur you to. Speaker 500:19:42So we are in basically the Speaker 800:19:48start of our discussion with the CMDA and during advance there, we do expect Speaker 500:20:00that to continue Speaker 600:20:07So sorry, was Japan also early 2025? Speaker 200:20:11We haven't given like timelines yet. What we'll say is that we're in productive discussions and we'll update as soon as we have line of sight. Speaker 600:20:19Okay, got it. And thanks. And then for my follow-up, just on in Q3, so your reported active patient numbers came in above our estimate across virtually all regions. The prescription numbers weren't too far off our model. So that would imply longer treatment duration in those key markets. Speaker 600:20:41Can you give any color there as far as what you're seeing on treatment duration as those are still consistent with what you saw in ES-fourteen, if that's Speaker 400:20:51changed? Thanks. Speaker 700:20:53Hi, Liz. This is Frank speaking. Thanks for mentioning the active patient growth across all the active markets. I mean, we're incredibly proud to have achieved over 4,000 patients on therapy for the first time. What I'll note is something that Ashley noted in the script, which is that we are focused on the end to end patient journey, which includes not just focusing on duration, but also helping more patients convert from the time of prescription to a start. Speaker 700:21:23And so I think I wouldn't look at it in terms of just pure growth in duration and really think about it as a continuum along that process and we're committed to improving across the board. Speaker 400:21:42Thank you. Operator00:21:47Our next question comes from Jason Bednar of Piper Sandler. Your line is open. Speaker 900:21:54Hey, good morning. A lot of congrats to go around to Saab and Ashley and on the recent FDA approval. First question from us is really kind of a 2 parter, I guess, related to the lung approval. You mentioned some of the next steps here, you launched in the U. S, making sure you're getting prescriptions written for patients that fit your label. Speaker 900:22:16I know this is going to build over time, but maybe can you help us with how you're internally thinking about the ramp of take in terms of treating physicians or the number of physicians you're going to be on boarding, the number of scripts or patients that maybe you might expect in the 1st year of your launch. Is there anything you're willing to share there? And then just yes, and I don't want to get too far out of ourselves, but Street's modeling $10,000,000 in revenue from lung for 2025. Is that a number that you're comfortable with or you're willing to bless today? Speaker 700:22:48Yes. Jason, this is Frank again. Thank you for the question. Just in terms of our approach to launch, I'll reiterate some things that we said before. I think first, actually, I'll start with saying that we're very pleased with the label that we think we have a very broad label that fits with how the trial is conducted and it gives us really good platform to engage physicians. Speaker 700:23:102 is that we're anchoring the launch to the fact that there is a very high unmet medical need for patients who are in platinum failure metastatic platinum failure disease. And so accordingly, what we're really focused on right now is getting our teams in the field to meet with physicians to make sure we have the right highly motivated physicians who are interested in integrating 2 or 3 fields into their practice. We really want to work on then finding the right patients for them, those patients who can succeed on the therapy. And then lastly, I think it comes down to the right time. So it's right physician, right patient and right time. Speaker 700:23:49And where we always see Tumor Treating Fields having the best potential for a benefit is when you start as early as possible. So we're trying to get process in place with our physicians to capture patients as they move to as they see disease progression immediately. And so really the message for the coming year is right physician, right patient, right time. And I'll say that we think while we don't give specific guidance, I'd say I think that translates over to that focus on good execution rather than sort of a maximum revenue effort next year. Speaker 900:24:29Okay. Thanks, Frank. And maybe to dovetail off of that as we think about the reimbursement strategy for lung, can you talk about in what ways this might be similar or different to what you established with GBM several years ago when we work to get payer coverage for a new indication then? Do you start commercial and then go after Medicare, like you did with that process? Does the timeline on getting coverage move faster knowing that you already have a reference rate with GBM and experience with the payers covering the technology? Speaker 700:25:04Yes, absolutely. So let me answer the question specifically and then I'll give some color, which is we broadly anticipate it will take 1 to 2 years to achieve broad reimbursement coverage. The way that we'll achieve that will most likely go with better success first with private payers and then moving into the original Medicare fee for service program. But our focus in the U. S. Speaker 700:25:30Is going to be on accepting patients who meet the essential meet the label and meet the profile of patients in the clinical trials and then begin working with the payers over the 1 to 2 years to get success. We're not going to specifically target 1 payer segment population on the other. Speaker 900:25:52Okay. But right to think that you start commercial then go Medicare, do you need sorry, just to maybe follow-up. Do you need a certain base or size or scale of commercial before you expect Medicare to provide full coverage? Speaker 700:26:10Well, Jason, this is where I'd anchor back to the 1 to 2 years. So just I think about the total population and the total effort as something that will play out over 1 to 2 years. Speaker 900:26:20Okay. Got it. Thank you. Speaker 700:26:23Thank you. Operator00:26:24Thank you. Our next question comes from Jonathan Chang of Leerink Partners. Your line is open. Speaker 1000:26:35Hi, guys. Thanks for taking the questions. First question on the planned transitions to the management team. Can you talk about how we should be thinking about potential changes in overall company strategy? And second question, can you discuss the latest progress for the Optune's lung cancer regulatory view in Germany? Speaker 1000:26:56And do you expect to get a similarly broad label as with the U. S? Thank you. Speaker 200:27:02Hi, Jonathan. This is Ashley. Maybe I'll start Speaker 400:27:04with the first question and Speaker 200:27:05then hand it over for the Speaker 400:27:06operator update on the TAV process. So I mean, Speaker 200:27:09zooming out too much NovoCure has been since the beginning focus on bringing tumor treating field to patients with aggressive forms of cancer. That will not change. And when we look at our 2024 objectives and what we need to do to deliver value looking forward, that also does not change. We need to continue to grow GBM. We need to have a a successful launch along and then we need to deliver on our pipeline. Speaker 200:27:32So it's a broad stroke. I will very much be focused on making sure that we have pull through on those strategic pillars. I'll continue to put more fine tooth details on that both with our internal and external messaging over the next couple of months. But I would say, we know what we need to do and we remain committed to doing. Speaker 500:27:52And regarding the CEMA, basically there are no updates since last Speaker 800:28:00quarter. And we are waiting and anticipate that we'll see the same coming. Speaker 1000:28:11Understood. Thank you. Operator00:28:15Thank you. Our next question comes from Emily Bodnar of H. C. Wainwright. Your line is open. Speaker 1100:28:28Hi, good morning. Thanks for taking the questions and also my congratulations as well. I'm curious about what your approach to marketing and lung is for particularly patients who have received checkpoint inhibitors in the first line setting and what the kind of initial feedback from physicians has been on whether they kind of see benefit in prescribing Optune to patients who are PD-one experienced? And then if you can provide any timing on potential data for LUNAR-two and LUNAR-four studies? Thank you. Speaker 700:29:02Hi, this is Frank again. So to talk about the strategy in terms of the launch and the engagement with physicians, I think number 1, again, I'll go back to the fact that we're very pleased with the label that we've received, which does allow us to have tumor treating field used concurrently with the new checkpoint inhibitor. And what I'll say again is that we do see in discussions with physicians is clear recognition of an unmet need, because these are patients who are post platinum failure, do not have a driver mutation and really have not seen any improvement in survival in the last 8 years. And so there's sort of a clear need to deliver better care to that patient population. I saw this personally last week as I was in the field where I had the chance to meet with someone who was an investigator in the LUNAR trial and an investigator now in our LUNAR-two trial. Speaker 700:30:00And they were really working through now how do we bring tumor treating fields into the tumor board to make sure that as our patients are noted for progression that we can put them through a screening process. So what I'd say is that our initial experience has been really strong engagement with physicians. And as we get a little bit further into the launch, we would probably feel more comfortable commenting on which patients are selecting. We're literally 2 weeks into this right now. So again, I just go back to the fact that what we see consistently is a recognition of a high unmet need and then an attempt to figure out the right way to bring it into practice. Speaker 1200:30:45Emily, this is Nicholas. Good morning. I'll take the second part of your questions about the trials. So first of all, let me tell you that I'm incredibly proud of that FDA approval. And of course, we are excited about that. Speaker 1200:30:58And in terms of trials, we're recruiting in LUNAR-two and LUNAR-four. And you can imagine, I cannot give you clear numbers, but we feel the momentum among the investigators. Speaker 1100:31:14Okay, great. Thanks so much. Operator00:31:18Thank you. Our next question comes from Jessica Fye of JPMorgan. Your line is open. Speaker 200:31:29Hey guys, good morning. Thanks for taking my Speaker 100:31:31questions. If PENOVA III pancreatic trial is successful, can you talk a bit about how we should think about when you would be ready to file for approval in the U. S. And Europe? And then second, you mentioned the next gen arrays could be a headwind to gross margins in the future. Speaker 100:31:48Can you just give us a sense of the magnitude there? Thank you. Speaker 200:31:52Yes. Jeff, this is Ashley. I'll take those. So I would say I would anchor to industry norms when we think about time to go from data to approval. What we know is that it takes 1 to 2 quarters to get the package pressed and then we expect the review time to take another 9 to 12 months. Speaker 200:32:09So that's what I would aim to do for PENOVA-three as well as all of our clinical trials. That's PENOVA. When we headwinds to gross margin. Thank you. I would expect gross margin depending on where we land with net revenue per active patient, which is actually largely driven by the success of our lung cancer launch, remember where we will Speaker 400:32:40be treating patients ahead of reimbursement in Speaker 200:32:43the 1st couple of quarters, to remain in the 70s. And if lung is going really well, you're going to have a lower 70 number, you're going to be more towards the mid, if it's if we have less rapid uptake with lung. So it is actually far more dependent on the net revenue per accretion that we're able to build than it is on COGS itself. We've talked about the headwinds from COGS from the launch of our next generation array, but those will wash through fairly quickly. Within a couple of quarters, we'll be back down to kind of a manufacturing optimized price point there. Speaker 200:33:16Zooming out, I would say over the course of the next 6 quarters, 6 to 8 quarters, we would expect all of that to wash out Speaker 400:33:23and we'll be back in the margins we're looking at today. Thank you. Operator00:33:29Thank you. Our next question comes from Vijay Kumar of Evercore ISI. Your line is open. Speaker 1300:33:43Hi. This is Kevin on for Vijay. Just a question on the reimbursement pathway for lung cancer. So just to follow-up on Jason's point on similarities versus differences in the past. Are you expecting a CMS panel this time around as well? Speaker 1300:34:04And how should we think about some of the barriers towards reimbursement in the U. S? Thank you. Speaker 700:34:13Hi. Thanks for the question. This is Frank. I would say, again, I'd start with the big picture, which is that we expect the entire process of gaining reimbursement across both private payers and the Medicare program to play out over 1 to 2 years. In terms of the specifics of how we will approach CMS and what steps will happen with CMS, I would add the color that we've been in dialogue with CMS and we do have multiple different pathways to approach them to request coverage. Speaker 700:34:46I think it's too early for us to give comments on specifics of how that will play out. And so again, I think I would think about this just in the context that it's reimbursement is always very complex. There are multiple pathways to get to the end and really just think about it as a 1 to 2 year program in totality and we'll give updates as we have more specifics. Speaker 1300:35:09Thank you. Operator00:35:12Thank you. I'm showing no further questions at this time. I'd like to turn it back to Bill Doyle for closing remarks. Speaker 300:35:20So let me thank you all for your continued interest in our progress at Novocure. When we entered this year, 2024, we stated both externally and internally 3 clear goals: grow GBM, deliver on the promise of our pipeline and launch long. Here as we report Q3, I'm very pleased that we've made significant and important progress on all three. We're delighted to report 22% top line growth year over year. We have a long list in terms of delivering on our pipeline, starting with the METIS successful readout, FDA providing breakthrough designation, of course, the FDA approval of LUNAR with the broad label that we had sought. Speaker 300:36:20And then the LPI, the last patients in for both Trident earlier in the year and this quarter PENOVA-four. And then initiating the important trial of KEYNOTE-fifty eight. That's a long list. I could make a longer list if I were to describe all the work that's being done in our preclinical and our clinical teams. And then finally, from a commercial perspective, launch lung. Speaker 300:36:49And as Frank described, we were prepared and we launched the day after receiving FDA approval and have received our first prescriptions. So it's been a great year and a great quarter of achievement. I am going to end by taking Asaf. I must admit for me personally, it's bittersweet. He deserves retirement. Speaker 300:37:17He spent 2 years planning to position Novocure in the strong position that we're in, but I'm going to miss it. And with that, thank you very much. Operator00:37:34This concludes today's conference call. Thank you for participating and you may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallNovoCure Q3 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) NovoCure Earnings HeadlinesStockNews.com Upgrades NovoCure (NASDAQ:NVCR) to HoldApril 19 at 2:31 AM | americanbankingnews.comWedbush Comments on NovoCure's Q1 Earnings (NASDAQ:NVCR)April 19 at 1:34 AM | americanbankingnews.comThe Trump Dump is starting; Get out of stocks now?The first 365 days of the Trump presidency… Will be the best time to get rich in American history.April 20, 2025 | Paradigm Press (Ad)Analysts Set NovoCure Limited (NASDAQ:NVCR) Target Price at $34.50April 18 at 3:31 AM | americanbankingnews.comNovocure price target lowered to $27 from $29 at WedbushApril 18 at 1:40 AM | markets.businessinsider.comNovoCure (NVCR) Expected to Announce Quarterly Earnings on ThursdayApril 17 at 3:49 AM | americanbankingnews.comSee More NovoCure Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like NovoCure? Sign up for Earnings360's daily newsletter to receive timely earnings updates on NovoCure and other key companies, straight to your email. Email Address About NovoCureNovoCure (NASDAQ:NVCR), an oncology company, engages in the development, manufacture, and commercialization of tumor treating fields (TTFields) devices for the treatment of solid tumor cancers in the United States, Germany, Japan, Greater China, and internationally. The company's TTFields devices include Optune Gio and Optune Lua. It also has ongoing clinical trials investigating TTFields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer, and ovarian cancer. NovoCure Limited was incorporated in 2000 and is headquartered in Saint Helier, Jersey.View NovoCure ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Archer Aviation Unveils NYC Network Ahead of Key Earnings Report3 Reasons to Like the Look of Amazon Ahead of EarningsTesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? Why Analysts Boosted United Airlines Stock Ahead of EarningsLamb Weston Stock Rises, Earnings Provide Calm Amidst ChaosIntuitive Machines Gains After Earnings Beat, NASA Missions Ahead Upcoming Earnings Tesla (4/22/2025)Intuitive Surgical (4/22/2025)Verizon Communications (4/22/2025)Canadian National Railway (4/22/2025)Novartis (4/22/2025)RTX (4/22/2025)3M (4/22/2025)Capital One Financial (4/22/2025)General Electric (4/22/2025)Danaher (4/22/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
There are 14 speakers on the call. Operator00:00:00Good day and thank you for standing by. Welcome to the Novicore Q3 2024 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. Operator00:00:33I would now like to hand the conference over to your speaker today, Ingrid Goldberg. Please go ahead. Speaker 100:00:42Good morning, and thank you for joining us to review Novocure's Q3 2024 performance. I'm on the phone this morning with our Executive Chairman, Bill Doyle our CEO, Asaf Dhanbiger and our CFO, Ashley Cordova. Other members of our executive leadership team will be available for Q and A. For your reference, slides accompanying this earnings release can be found on our website, www.novacare.com, on the Investor Relations page under Quarterly Reports. Before we start, I would like to remind you that our discussions during this conference call will include forward looking statements and actual results could differ materially from those projected in these statements. Speaker 100:01:21These 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. Speaker 200:01:28We do Speaker 100:01:28not 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 best reflects the financial value generated by our business. Reconciliations of non GAAP to GAAP financial measures are included in our press release, earnings slides and in our Form 8 ks filed with the SEC today. These materials can also be accessed from the Investor Relations page of our website. Speaker 100:02:10Following 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, and good morning. Speaker 300:02:19At Novocure, our mission is to extend survivals in some of the most aggressive forms of cancer. Our efforts have focused largely on glioblastoma, but with the recent approval of OptuneLA for non small cell lung cancer, we are launching our next large indication. Launching Tumor Treating Fields therapy in non small cell lung cancer is an important achievement for NovoCure. We are eager to bring a new and urgently needed therapeutic option to patients in need. This morning, we will begin with a discussion of our non small cell lung cancer approval and launch plans, followed by a GBM business review, clinical pipeline update and review of Novocure's Q3 financial performance. Speaker 300:03:072 weeks ago, the FDA approved our PMA for OptuneLA to treat post platinum metastatic non small cell lung cancer together with either an immune checkpoint inhibitor or docetaxel. As you know, TT field therapy is already approved to treat glioblastoma and mesothelioma, rare forms of brain and thoracic cancer. Our approval to treat non small cell lung cancer means our innovative therapy will be an option for a large and growing patient population with an urgent and unmet need for effective therapies in the 2nd line. For months, we have been preparing for this launch. The lung team was hired over the summer and has undergone extensive scientific training. Speaker 300:03:54We have had a substantial presence at oncology congresses around the world, including ELCC, ASCO, WCLC and ESMO, providing an opportunity for physicians to learn about TT field therapy. We have had numerous advisory boards to ensure we fully understand the physician and patient needs. Our marketing team is prepared with a suite of resources for providers, care teams, patients and caregivers. Physician and patient focused websites were launched the day after approval and our sales team was fully trained and in the field the following Monday. We are pleased to report that our first round of physicians have completed certification and we received our first lung prescription shortly after approval. Speaker 300:04:45Our launch is well underway. We are also preparing for launch in Germany and Japan in anticipation of regulatory approvals. As noted last quarter, the new MDR process has lengthened regulatory review timelines in Europe. While the review process has taken longer than originally projected, we remain hopeful for a final decision in the coming months. In Japan, we have submitted our application to the PMDA and productive conversations are ongoing. Speaker 300:05:15We will be launch ready upon approval in both of these important markets. I am incredibly proud of the efforts of our team to bring TTFields therapy to non small cell lung cancer patients. So many people across Novocure have contributed to this milestone. Also, we would not have been able to celebrate this moment today without the partnership and commitment of our patients, their families and caregivers and the physicians, researchers and healthcare professionals that have taken part in our clinical trials. Thank you all. Speaker 300:05:48This is an important achievement for patients. As we prepare for a new chapter at Novocure, we are pleased to implement planned changes to our executive team that will position Novocure for long term success. Last month, we announced the retirement at the end of this year of our CEO, Assaf Donsinger. Assaf has been with Novocure for 22 years and has shepherded our company through our successful clinical trials, regulatory approvals, engineering advances and the launch of our successful GBM business. Under Assaf's leadership, we have grown from a small team in Israel to an international company of over 1400 employees. Speaker 300:06:32We knew the day would come when Asaf would choose to retire and to prepare, we have been cultivating a strong bench of leaders. When the Board began the process to identify Asaf successor, our goal was to find a candidate with substantial institutional knowledge, experience managing and expanding global organization and a deep understanding of our clinical and commercial opportunities. Ashley Cordova embodies all of these characteristics. Ashley has been integral to scaling NovoCure's global operations and infrastructure since joining the company in 2014. Her commitment to our patients and strategic vision are exceptional as is her record of accomplishment as our CFO. Speaker 300:07:18We are delighted Ashley has accepted the challenge and confident she is the right choice to drive NovoCure's next stage of growth. This morning, we also announced Christophe Brackmann has joined Novocure as our next CFO, replacing Ashley in this role. Christophe joins Novocure this week and will assume the CFO position on January 1. Christophe was most recently the Senior Vice President of Finance at Moderna and he brings a wealth of experience in the biotechnology and pharmaceutical industries. Christophe was instrumental to Moderna's scale up during the COVID pandemic. Speaker 300:07:56His external perspective will be an important addition to our executive team. Finally, in October, Mukun Paravashu took over as our COO, following the retirement of Wilco Grundhuysen. With these additions to our executive leadership, the Board and I believe we have the team in place that will lead Novocure to the next levels of growth. Before I pass the call over to Ashley, I would like to extend my personal thanks to Asaf for his 22 years of dedication to Novocure. Asaf and I were young men when we embarked on the journey to bring Tumor Treating Fields Therapy to patients, and I know we would not have succeeded and Novocure would not exist today without Asahi. Speaker 300:08:46Ashley? Speaker 400:08:48Thank you, Bill. It is an exciting time to be at Novocure and I am both humbled and energized by the opportunity to lead this company into a bright future. Throughout 2024, we have taken steps to return our GBM business to growth through a focus on prescription conversion, patient persistence and cross functional alignment. This quarter, we saw the fruits of these initiatives across all major markets with global active patient growth of 13% year over year. We ended the quarter with a record 4,113 active patient blood therapy, breaking the 4,000 patient threshold for the first time. Speaker 400:09:32This helped us deliver 22% year over year top line growth. We have also seen substantial progress across our clinical programs. Our next clinical milestone will be top line data from our Phase 3 PANOVA trial later this year. PANOVA 3 is studying the use of tumor treating field therapy with gemcitabine and nab paclitaxel for the treatment of unresectable locally advanced pancreatic cancer. We recently completed patient follow-up and are now finalizing data collection and analyses. Speaker 400:10:09This quarter, we also completed enrollment in our Phase 2 PANOVA 4 trial, which adds Roche's immune check point inhibitor atezolizumab to tumor treating field therapy gemcitabine and nab paclitaxel for the treatment of metastatic pancreatic cancer. As a reminder, PENOVA-four was launched in mid-twenty 23, just 5 quarters ago and was designed to enroll 76 patients. We are pleased with the excitement and engagement of the pancreatic cancer community around this trial and are eager to better understand the potential of tumor treating field therapy in this setting. Our next indication to be submitted to the FDA for PMA review will be the treatment of brain metastases for non small cell lung cancer. As a reminder, we presented data from the Phase 3 METIS trial at ASCO in June. Speaker 400:11:01METIS met its primary endpoint, demonstrating a median time to intracranial progression of 21.9 months for patients using tumor treating field therapy compared to 11.3 months for patients randomized to the control. Importantly, the META status showed patients treated with tumor treating fields maintained quality of life and cognitive function, key challenges in the treatment of brain metastases. We are pleased to announce today that the FDA has granted breakthrough device designation for the use of tumor treating field therapy for brain metastases from non small cell lung cancer. Breakthrough device designation gives us more frequent, faster and interactive access to the FDA review team and senior management during the review process, priority review of our marketing application upon filing, and expedited review of pre PMA manufacturing and quality systems compliance inspection. We expect to file the PMA in early 2025. Speaker 400:12:08Following on the success of the LUNAR trial in metastatic non small cell lung cancer are our Phase 3 LUNAR II and Phase 2 LUNAR IV trials. LUNAR II is studying tumor treating fields together with platinum chemotherapy and pembrolizumab in the first line. LUNAR-four is setting treatment with tumor treating field therapy and pembrolizumab in the second line following first line treatment with a checkpoint inhibitor and platinum based chemotherapy. Both are open and actively enrolling patients and important to our ongoing efforts to establish and increase adoption of tumor treating field therapy in non small cell lung. We also have 2 ongoing Phase 3 trials in GBM, TRIDENT and KEYNOTE-fifty eight. Speaker 400:12:56The TRIDENT trial is studying the benefit of starting Optune GEO earlier in the patient journey concurrent with chemoradiation rather than following chemoradiation. Trident completed enrollment last January and patients are currently in the 2 year follow-up period, with data expected in 2026. We are initiating sites for the KEYNOTE-fifty eight trial, studying the addition of pembrolizumab to the current GBM standard of care, Optune GEO plus temozolomide following chemoradiation. KEYNOTE-fifty eight is an exciting opportunity to build upon the results of the Phase 2 TO THE TOP trial and study the benefits of using tumor treating field therapy with immune checkpoint inhibitors in newly diagnosed GBM. Turning to our financial performance for the Q3, top line growth was strong. Speaker 400:13:54Q3 net revenues were $155,000,000 an increase of 22% from the same period last year. The increase was largely driven by active patient growth in our key markets and improved approval rates in the United States. The improved U. S. Approval rates contributed $5,000,000 in Q3 net revenues from prior period billings. Speaker 400:14:18Looking ahead, we do not expect to see an incremental one time benefit from prior periods as the improved approval rates are now considered in our baseline revenue run rate. Gross margin in the Q3 was 77% compared to 75% in the Q3 of 2023. This improvement was driven by a higher net revenue per patient due to the increase in U. S. Approval rates and our strong performance in France. Speaker 400:14:48Looking ahead, we expect the global launch of our next generation arrays as a non small cell lung cancer indication to be headwinds to gross margin. SG and A expenses were $100,000,000 in the 3rd quarter, in line with Q3 2023. Our sales and marketing expenses increased year over year in support of our lung cancer launch, offset by lower personnel costs and G and A. Research and development expenses in the quarter totaled $52,000,000 a decrease of 3% from the same period in 2023. Our net loss for the quarter was $31,000,000 or $0.28 per share. Speaker 400:15:29Adjusted EBITDA was $2,000,000 an increase of $31,000,000 compared to the same period last year and our 2nd quarter in a row with positive adjusted EBITDA. This was largely driven by the increase in net revenues as well as material benefits from reduced operating expenses resulting from the strategic restructuring we undertook at the end of 2023. As we continue to invest in growth, profitability remains an important goal and something we are actively driving towards. As Bill noted earlier, Asaf will be retiring at the end of the year. So this will be his final earnings call. Speaker 400:16:12I would like to personally thank Asaf for his friendship and leadership over the past 10 years and will now turn the call over to him for some parting words. Speaker 500:16:22Thank you, Ashley. When I joined Professor Palti, NovoCure was a company of a few people in a preclinical lab, working to bring TT Fields therapy to the fight against cancer. Today, NovoCure is a team of more than 1400 and is treating thousands of cancer patients across the globe. I'm very proud of how far we have come and of the lives we have affected. And I know NovoCure is poised for greater things ahead under Ashley's leadership. Speaker 500:16:57We have worked together for more than a decade, so I know Ashley has the passion and tenacity needed to take NovoCube to the next level. Ashley has been integral to NovoCube's evolution from small company to global organization and for ensuring we have had the financial structure and strength to support our growth. There is no one better to lead us into the future. I would like to thank all my colleagues for an incredible journey. Your dedication to our patients is an inspiration, and I know your commitment to our patient centric mission will continue to guide your work at NovoCure. Speaker 500:17:40Finally, I would like to thank our patients, their families and caregivers, physicians and care teams for putting your faith in us. Our mission has always been personal to me and something I take extremely seriously. There is nothing more sacred than giving someone more time with the people they love, and I will always be grateful for the opportunity to contribute to each and every patient's journey. Thank you. I will now hand the call back to the operator. Speaker 400:18:15Thank you. Operator00:18:35And our first question comes from Larry Biegelsen of Wells Fargo. Your line is open. Speaker 600:18:43Hi, good morning. It's Lyric Lei calling in for Larry. Can you hear me okay? Speaker 700:18:49Good. Speaker 600:18:52First, a softest congratulations on your retirement. Well deserved. As far as questions, just on LUNAR, what are you saying about the revenue per patient for OptumLula? And as far as treatment duration, should we think about kind of the 4 to 5 months average? And along with that, what are you expecting on timing for Japan approval? Speaker 600:19:18And I have a follow-up. Speaker 200:19:22This is Ashley. I'll jump in just quickly with the first question. We would expect the pricing to be in line with the afternoon to you pricing. And you are right, that's a 4 to 5 months is what I would model. That's what we saw in the clinical trial. Speaker 200:19:34And until we have more commercial experience, that's what we would incur you to. Speaker 500:19:42So we are in basically the Speaker 800:19:48start of our discussion with the CMDA and during advance there, we do expect Speaker 500:20:00that to continue Speaker 600:20:07So sorry, was Japan also early 2025? Speaker 200:20:11We haven't given like timelines yet. What we'll say is that we're in productive discussions and we'll update as soon as we have line of sight. Speaker 600:20:19Okay, got it. And thanks. And then for my follow-up, just on in Q3, so your reported active patient numbers came in above our estimate across virtually all regions. The prescription numbers weren't too far off our model. So that would imply longer treatment duration in those key markets. Speaker 600:20:41Can you give any color there as far as what you're seeing on treatment duration as those are still consistent with what you saw in ES-fourteen, if that's Speaker 400:20:51changed? Thanks. Speaker 700:20:53Hi, Liz. This is Frank speaking. Thanks for mentioning the active patient growth across all the active markets. I mean, we're incredibly proud to have achieved over 4,000 patients on therapy for the first time. What I'll note is something that Ashley noted in the script, which is that we are focused on the end to end patient journey, which includes not just focusing on duration, but also helping more patients convert from the time of prescription to a start. Speaker 700:21:23And so I think I wouldn't look at it in terms of just pure growth in duration and really think about it as a continuum along that process and we're committed to improving across the board. Speaker 400:21:42Thank you. Operator00:21:47Our next question comes from Jason Bednar of Piper Sandler. Your line is open. Speaker 900:21:54Hey, good morning. A lot of congrats to go around to Saab and Ashley and on the recent FDA approval. First question from us is really kind of a 2 parter, I guess, related to the lung approval. You mentioned some of the next steps here, you launched in the U. S, making sure you're getting prescriptions written for patients that fit your label. Speaker 900:22:16I know this is going to build over time, but maybe can you help us with how you're internally thinking about the ramp of take in terms of treating physicians or the number of physicians you're going to be on boarding, the number of scripts or patients that maybe you might expect in the 1st year of your launch. Is there anything you're willing to share there? And then just yes, and I don't want to get too far out of ourselves, but Street's modeling $10,000,000 in revenue from lung for 2025. Is that a number that you're comfortable with or you're willing to bless today? Speaker 700:22:48Yes. Jason, this is Frank again. Thank you for the question. Just in terms of our approach to launch, I'll reiterate some things that we said before. I think first, actually, I'll start with saying that we're very pleased with the label that we think we have a very broad label that fits with how the trial is conducted and it gives us really good platform to engage physicians. Speaker 700:23:102 is that we're anchoring the launch to the fact that there is a very high unmet medical need for patients who are in platinum failure metastatic platinum failure disease. And so accordingly, what we're really focused on right now is getting our teams in the field to meet with physicians to make sure we have the right highly motivated physicians who are interested in integrating 2 or 3 fields into their practice. We really want to work on then finding the right patients for them, those patients who can succeed on the therapy. And then lastly, I think it comes down to the right time. So it's right physician, right patient and right time. Speaker 700:23:49And where we always see Tumor Treating Fields having the best potential for a benefit is when you start as early as possible. So we're trying to get process in place with our physicians to capture patients as they move to as they see disease progression immediately. And so really the message for the coming year is right physician, right patient, right time. And I'll say that we think while we don't give specific guidance, I'd say I think that translates over to that focus on good execution rather than sort of a maximum revenue effort next year. Speaker 900:24:29Okay. Thanks, Frank. And maybe to dovetail off of that as we think about the reimbursement strategy for lung, can you talk about in what ways this might be similar or different to what you established with GBM several years ago when we work to get payer coverage for a new indication then? Do you start commercial and then go after Medicare, like you did with that process? Does the timeline on getting coverage move faster knowing that you already have a reference rate with GBM and experience with the payers covering the technology? Speaker 700:25:04Yes, absolutely. So let me answer the question specifically and then I'll give some color, which is we broadly anticipate it will take 1 to 2 years to achieve broad reimbursement coverage. The way that we'll achieve that will most likely go with better success first with private payers and then moving into the original Medicare fee for service program. But our focus in the U. S. Speaker 700:25:30Is going to be on accepting patients who meet the essential meet the label and meet the profile of patients in the clinical trials and then begin working with the payers over the 1 to 2 years to get success. We're not going to specifically target 1 payer segment population on the other. Speaker 900:25:52Okay. But right to think that you start commercial then go Medicare, do you need sorry, just to maybe follow-up. Do you need a certain base or size or scale of commercial before you expect Medicare to provide full coverage? Speaker 700:26:10Well, Jason, this is where I'd anchor back to the 1 to 2 years. So just I think about the total population and the total effort as something that will play out over 1 to 2 years. Speaker 900:26:20Okay. Got it. Thank you. Speaker 700:26:23Thank you. Operator00:26:24Thank you. Our next question comes from Jonathan Chang of Leerink Partners. Your line is open. Speaker 1000:26:35Hi, guys. Thanks for taking the questions. First question on the planned transitions to the management team. Can you talk about how we should be thinking about potential changes in overall company strategy? And second question, can you discuss the latest progress for the Optune's lung cancer regulatory view in Germany? Speaker 1000:26:56And do you expect to get a similarly broad label as with the U. S? Thank you. Speaker 200:27:02Hi, Jonathan. This is Ashley. Maybe I'll start Speaker 400:27:04with the first question and Speaker 200:27:05then hand it over for the Speaker 400:27:06operator update on the TAV process. So I mean, Speaker 200:27:09zooming out too much NovoCure has been since the beginning focus on bringing tumor treating field to patients with aggressive forms of cancer. That will not change. And when we look at our 2024 objectives and what we need to do to deliver value looking forward, that also does not change. We need to continue to grow GBM. We need to have a a successful launch along and then we need to deliver on our pipeline. Speaker 200:27:32So it's a broad stroke. I will very much be focused on making sure that we have pull through on those strategic pillars. I'll continue to put more fine tooth details on that both with our internal and external messaging over the next couple of months. But I would say, we know what we need to do and we remain committed to doing. Speaker 500:27:52And regarding the CEMA, basically there are no updates since last Speaker 800:28:00quarter. And we are waiting and anticipate that we'll see the same coming. Speaker 1000:28:11Understood. Thank you. Operator00:28:15Thank you. Our next question comes from Emily Bodnar of H. C. Wainwright. Your line is open. Speaker 1100:28:28Hi, good morning. Thanks for taking the questions and also my congratulations as well. I'm curious about what your approach to marketing and lung is for particularly patients who have received checkpoint inhibitors in the first line setting and what the kind of initial feedback from physicians has been on whether they kind of see benefit in prescribing Optune to patients who are PD-one experienced? And then if you can provide any timing on potential data for LUNAR-two and LUNAR-four studies? Thank you. Speaker 700:29:02Hi, this is Frank again. So to talk about the strategy in terms of the launch and the engagement with physicians, I think number 1, again, I'll go back to the fact that we're very pleased with the label that we've received, which does allow us to have tumor treating field used concurrently with the new checkpoint inhibitor. And what I'll say again is that we do see in discussions with physicians is clear recognition of an unmet need, because these are patients who are post platinum failure, do not have a driver mutation and really have not seen any improvement in survival in the last 8 years. And so there's sort of a clear need to deliver better care to that patient population. I saw this personally last week as I was in the field where I had the chance to meet with someone who was an investigator in the LUNAR trial and an investigator now in our LUNAR-two trial. Speaker 700:30:00And they were really working through now how do we bring tumor treating fields into the tumor board to make sure that as our patients are noted for progression that we can put them through a screening process. So what I'd say is that our initial experience has been really strong engagement with physicians. And as we get a little bit further into the launch, we would probably feel more comfortable commenting on which patients are selecting. We're literally 2 weeks into this right now. So again, I just go back to the fact that what we see consistently is a recognition of a high unmet need and then an attempt to figure out the right way to bring it into practice. Speaker 1200:30:45Emily, this is Nicholas. Good morning. I'll take the second part of your questions about the trials. So first of all, let me tell you that I'm incredibly proud of that FDA approval. And of course, we are excited about that. Speaker 1200:30:58And in terms of trials, we're recruiting in LUNAR-two and LUNAR-four. And you can imagine, I cannot give you clear numbers, but we feel the momentum among the investigators. Speaker 1100:31:14Okay, great. Thanks so much. Operator00:31:18Thank you. Our next question comes from Jessica Fye of JPMorgan. Your line is open. Speaker 200:31:29Hey guys, good morning. Thanks for taking my Speaker 100:31:31questions. If PENOVA III pancreatic trial is successful, can you talk a bit about how we should think about when you would be ready to file for approval in the U. S. And Europe? And then second, you mentioned the next gen arrays could be a headwind to gross margins in the future. Speaker 100:31:48Can you just give us a sense of the magnitude there? Thank you. Speaker 200:31:52Yes. Jeff, this is Ashley. I'll take those. So I would say I would anchor to industry norms when we think about time to go from data to approval. What we know is that it takes 1 to 2 quarters to get the package pressed and then we expect the review time to take another 9 to 12 months. Speaker 200:32:09So that's what I would aim to do for PENOVA-three as well as all of our clinical trials. That's PENOVA. When we headwinds to gross margin. Thank you. I would expect gross margin depending on where we land with net revenue per active patient, which is actually largely driven by the success of our lung cancer launch, remember where we will Speaker 400:32:40be treating patients ahead of reimbursement in Speaker 200:32:43the 1st couple of quarters, to remain in the 70s. And if lung is going really well, you're going to have a lower 70 number, you're going to be more towards the mid, if it's if we have less rapid uptake with lung. So it is actually far more dependent on the net revenue per accretion that we're able to build than it is on COGS itself. We've talked about the headwinds from COGS from the launch of our next generation array, but those will wash through fairly quickly. Within a couple of quarters, we'll be back down to kind of a manufacturing optimized price point there. Speaker 200:33:16Zooming out, I would say over the course of the next 6 quarters, 6 to 8 quarters, we would expect all of that to wash out Speaker 400:33:23and we'll be back in the margins we're looking at today. Thank you. Operator00:33:29Thank you. Our next question comes from Vijay Kumar of Evercore ISI. Your line is open. Speaker 1300:33:43Hi. This is Kevin on for Vijay. Just a question on the reimbursement pathway for lung cancer. So just to follow-up on Jason's point on similarities versus differences in the past. Are you expecting a CMS panel this time around as well? Speaker 1300:34:04And how should we think about some of the barriers towards reimbursement in the U. S? Thank you. Speaker 700:34:13Hi. Thanks for the question. This is Frank. I would say, again, I'd start with the big picture, which is that we expect the entire process of gaining reimbursement across both private payers and the Medicare program to play out over 1 to 2 years. In terms of the specifics of how we will approach CMS and what steps will happen with CMS, I would add the color that we've been in dialogue with CMS and we do have multiple different pathways to approach them to request coverage. Speaker 700:34:46I think it's too early for us to give comments on specifics of how that will play out. And so again, I think I would think about this just in the context that it's reimbursement is always very complex. There are multiple pathways to get to the end and really just think about it as a 1 to 2 year program in totality and we'll give updates as we have more specifics. Speaker 1300:35:09Thank you. Operator00:35:12Thank you. I'm showing no further questions at this time. I'd like to turn it back to Bill Doyle for closing remarks. Speaker 300:35:20So let me thank you all for your continued interest in our progress at Novocure. When we entered this year, 2024, we stated both externally and internally 3 clear goals: grow GBM, deliver on the promise of our pipeline and launch long. Here as we report Q3, I'm very pleased that we've made significant and important progress on all three. We're delighted to report 22% top line growth year over year. We have a long list in terms of delivering on our pipeline, starting with the METIS successful readout, FDA providing breakthrough designation, of course, the FDA approval of LUNAR with the broad label that we had sought. Speaker 300:36:20And then the LPI, the last patients in for both Trident earlier in the year and this quarter PENOVA-four. And then initiating the important trial of KEYNOTE-fifty eight. That's a long list. I could make a longer list if I were to describe all the work that's being done in our preclinical and our clinical teams. And then finally, from a commercial perspective, launch lung. Speaker 300:36:49And as Frank described, we were prepared and we launched the day after receiving FDA approval and have received our first prescriptions. So it's been a great year and a great quarter of achievement. I am going to end by taking Asaf. I must admit for me personally, it's bittersweet. He deserves retirement. Speaker 300:37:17He spent 2 years planning to position Novocure in the strong position that we're in, but I'm going to miss it. And with that, thank you very much. Operator00:37:34This concludes today's conference call. Thank you for participating and you may now disconnect.Read morePowered by