Q3 2024 Novocure Ltd Earnings Call

Speaker Change: Good day and thank you for standing by. Welcome to the Novatoric Q3 2024 earnings conference call.

Speaker Change: At this time, all participants are an elicinolimode after the speaker's presentation. There will be a question and answer session.

Speaker Change: To ask a question during the session, you will need to press star-11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star-11 again.

Speaker Change: Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today. Ingrid Goldberg, please go ahead.

Speaker Change: The

Ingrid Goldberg: Good morning and thank you for joining us to review Novator's third quarter 2024 performance.

Ingrid Goldberg: I'm on the phone this morning with our Executive Chairman, Bill Doyle, our CEO, Asaf Danziger, and our CFO Ashley Cordova.

Ingrid Goldberg: Other members of our Executive Leadership team will be available for Q&A.

Ingrid Goldberg: For your reference, fly the company this earnings release can be found on our website www.novecure.com On the Investor Relations page, under Coralary Report

Ingrid Goldberg: 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.

Ingrid Goldberg: 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 filing. We do not intend to update publicly and he forelooking statements except as required by law.

Ingrid Goldberg: We're appropriate, we refer to non-gapsian-animal measures to evaluate our business, specifically adjusted EBITDAF, a measure of earnings before interest, taxes, depreciation, amortization, and share-based compensation.

Ingrid Goldberg: We believe adjusted to the adapt, is an important metric as a remove the impact of earnings and trebidable to our capital structure, tax rate, and material non-cached items and best reflects the financial value generated by our business.

Ingrid Goldberg: Reconciliation of non-gap-to-gap financial measures are included in our press release, earning slides and in our form 8K filed with the SEC today.

Ingrid Goldberg: These materials can also be accessed from the Investor Relations page of our website.

Ingrid Goldberg: Following our prepared remarks today, we'll open line fair questions.

Speaker Change: I will now turn the call over to our Executive Chairman, Bill Doyle.

Bill Doyle: Thank you, Ingrid, and good morning. At Novacure, our mission is to extend survival in some of the most aggressive forms of cancer.

Bill Doyle: Our efforts have focused largely on glioblastoma, but with the recent approval of OptumLua for non-small cell lung cancer, we are launching our next large indication.

Bill Doyle: Launching tumor treating fields therapy in non-small cell lung cancer is an important achievement for Novacure.

Bill Doyle: We are eager to bring a new and urgently needed therapeutic option to patients in need.

Speaker Change: 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 Novacure's third quarter financial performance.

Speaker Change: Two weeks ago, the FDA approved our PMA for OptumLua to treat post-platinum metastatic non-small cell lung cancer together with either an immune checkpoint inhibitor or dosetaxel.

Speaker Change: 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 second line.

Speaker Change: For months, we have been preparing for this launch.

Speaker Change: The Lung team was hired over the summer and has undergone extensive scientific training.

Speaker Change: We 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-fields therapy.

Speaker Change: 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.

Speaker Change: 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.

Speaker Change: 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 Change: Our launch is well underway.

Speaker Change: We are also preparing for launch in Germany and Japan in anticipation of regulatory approvals.

Speaker Change: As noted last quarter, the new MDR process has lengthened regulatory review timelines in Europe.

Speaker Change: While the review process has taken longer than originally projected, we remain hopeful for a final decision in the coming months.

Speaker Change: In Japan, we have submitted our application to the PMDA and productive conversations are ongoing. We will be launch ready upon approval in both of these important markets.

Speaker Change: I am incredibly proud of the efforts of our team to bring TT Field's therapy to non-small-cell lung cancer patients.

Speaker Change: 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.

Speaker Change: Thank you all. This is an important achievement for patients.

Speaker Change: 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.

Speaker Change: Last month, we announced the retirement at the end of this year of our CEO, Asaf Danziger.

Speaker Change: Asaf has been with Novacure 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.

Speaker Change: Under Asaf's leadership, we have grown from a small team in Israel to an international company of over 1,400 employees.

Speaker Change: We knew the day would come when Asaf would choose to retire, and to prepare, we have been cultivating a strong bench of leaders.

Speaker Change: When the board began the process to identify Asaf's successor, our goal was to find a candidate with substantial institutional knowledge, experience managing an expanding global organization, and a deep understanding of our clinical and commercial opportunities.

Speaker Change: Ashley Cordova embodies all of these characteristics.

Speaker Change: Ashley has been integral to scaling NovaCare's global operations and infrastructure since joining the company in 2014.

Speaker Change: Her commitment to our patients and strategic vision are exceptional, as is her record of accomplishment as our CFO.

Speaker Change: We are delighted Ashley has accepted the challenge and confident she is the right choice to drive NovoCure's next stage of growth.

Speaker Change: This morning, we also announced Christoph Brackman has joined Novocure as our next CFO, replacing Ashley in this role.

Speaker Change: Christoph joins Novicure this week and will assume the CFO position on January 1st.

Speaker Change: Christoph was most recently the Senior Vice President of Finance at Moderna and he brings a wealth of experience in the biotechnology and pharmaceutical industries.

Speaker Change: Christoph was instrumental to Moderna's scale-up during the COVID pandemic.

Speaker Change: His external perspective will be an important addition to our executive team.

Speaker Change: Finally, in October, Mukun Paravasu took over as our COO following the retirement of Wilco Grünhausen.

Speaker Change: With these additions to our executive leadership, the board and I believe we have the team in place that will lead Novature to the next levels of growth.

Speaker Change: 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 Novacure.

Speaker Change: 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 Novacure would not exist today without Asaf.

Speaker Change: Ashley

Ashley Cordova: Thank you, Bill.

Ashley Cordova: 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.

Ashley Cordova: 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.

Ashley Cordova: This quarter, we saw the fruits of these initiatives across all major markets, with global active patient growth of 13% year over year.

Ashley Cordova: We ended the quarter with a record 4,113 active patients on therapy, breaking the 4,000 patient threshold for the first time.

Ashley Cordova: We have also seen substantial progress across our clinical programs.

Ashley Cordova: Our next clinical milestone will be top-line data from our Phase III PANOVA trial later this year.

Ashley Cordova: PANOVA3 is studying the use of tumor treating fields therapy with gemcitabine and nabpaclitaxel for the treatment of unrefectable locally advanced pancreatic cancer.

Ashley Cordova: We recently completed patient follow-up and are now finalizing data collection and analyses.

Ashley Cordova: This quarter, we also completed enrollment in our Phase 2 PANOVA4 trial, which adds Roche's Immune Checkpoint Inhibitor atezolizumab to tumor-treating field therapy, gemcitabine, and nabpaclitaxel for the treatment of metastatic pancreatic cancer.

Ashley Cordova: As a reminder, Panova IV was launched in mid-2023, just five quarters ago, and was designed to enroll 76 patients.

Ashley Cordova: 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.

Ashley Cordova: Our next indication to be submitted to the FDA for PMA review will be the treatment of brain metastases from non-cell cell lung cancer.

Ashley Cordova: As a reminder, we presented data from the Phase III MEDIS trial at ASCO in June.

Ashley Cordova: MEDIS 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.

Ashley Cordova: Importantly, the METIS data showed patients treated with tumor-treating fields maintained quality of life and cognitive function, key challenges in the treatment of brain metastases.

Ashley Cordova: 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-slot cell lung cancer.

Ashley Cordova: 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 inspections.

Ashley Cordova: We expect to file the PMA in early 2025.

Ashley Cordova: Following on the success of the LUNAR trial in metastatic non-spatial lung cancer are our Phase 3 LUNAR2 and Phase 2 LUNAR4 trials.

Ashley Cordova: Lunar 2 is studying tumor treating fields together with platinum chemotherapy and primrolizumab in the first line.

Ashley Cordova: Lunar4 is studying treatment with tumor treating field therapy and primordializumab in the second line following first line treatment with a checkpoint inhibitor and platinum-based chemotherapy.

Ashley Cordova: Both are open and actively enrolling patients and important to our ongoing efforts to establish and increase adoption of tumor-treating field therapy and non-small cell lungs.

Ashley Cordova: We also have two ongoing phase three trials in GBM, Trident and Keynote D58.

Ashley Cordova: The TRIDENTS trial is studying the benefit of starting OptumGeo earlier in the patient journey, concurrent with chemoradiation, rather than following chemoradiation.

Ashley Cordova: Trident completed enrollment last January and patients are currently in the two-year follow-up period with data expected in 2026.

Ashley Cordova: We are initiating sites for the Keynote D58 trial, studying the addition of pembrolizumab to the current GVM standard of care, optune GEO plus temozolomide following chemoradiation.

Ashley Cordova: Keynote D58 is an exciting opportunity to build upon the results of the phase two to the top trial and study the benefits of using tumor treating field therapy with immune checkpoint inhibitors in newly diagnosed GBM.

Speaker Change: Turning to our financial performance for the third quarter, top-line growth was strong.

Speaker Change: Q3 net revenues were $155 million, an increase of 22% from the same period last year.

Speaker Change: The increase was largely driven by active patient growth in our key markets and improved approval rates in the United States.

Speaker Change: The improved U.S. approval rates contributed $5 million in Q3 net revenues from prior period billing.

Speaker Change: Looking ahead, we do not expect to see an increment to one-time benefit from prior periods as the improved approval rates are now considered in our baseline revenue run rate.

Speaker Change: Growth margin in the third quarter was 77% compared to 75% in the third quarter of 2023.

Speaker Change: 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 Change: Looking ahead, we expect the global launch of our Next Generation Arrays as a non-small-cell lung cancer indication to be headwinds to growth margins.

Speaker Change: SG&A expenses were $100 million in the third 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&A.

Speaker Change: Research and development expenses in the quarter totaled $52 million, a decrease of 3% from the same period in 2023.

Speaker Change: Our net loss for the quarter was $31 million, or $0.28 per share.

Speaker Change: Adjusted EBITDA was $2 million, an increase of $31 million compared to the same period last year, and our second quarter in a row with positive adjusted EBITDA.

Speaker Change: 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.

Speaker Change: As Bill noted earlier, Asaf will be retiring at the end of the year, so this will be his final earnings call.

Bill Doyle: I would like to personally thank Asaf for his friendship and leadership over the past 10 years.

Bill Doyle: And we'll now turn the call over to him for some parting words.

Asaf Danziger: Thank 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.

Asaf Danziger: Today, NovoCure is a team of more than 1,400 and is treating thousands of cancer patients across the globe. I am very proud of how far we have come and of the lives we have affected.

Asaf Danziger: And I know Novocruz is poised for greater things ahead under Ashley's leadership.

Asaf Danziger: We have worked together for more than a decade, so I know Ashley has the passion and tenacity needed to take NovoQ to the next level.

Asaf Danziger: Ashley has been integral to Novocure'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.

Ashley Cordova: 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.

Ashley Cordova: Finally, I would like to thank our patients, their families and caregivers, physicians and care teams for putting your faith in us.

Ashley Cordova: 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.

Ashley Cordova: and I will always be grateful for the opportunity to contribute to each and every patient's journey. Thank you.

Ashley Cordova: I will now hand the call back to the operator.

Ashley Cordova: Thank you.

Speaker Change: And our first question comes from Larry Beagleson of Wells Fargo. Your line is open.

Speaker Change: Hi, good morning. It's Leigh calling in for Larry. Can you hear me okay?

Speaker Change: together.

Leigh: First, Asaf, just congratulations on your retirement. Well deserved.

Speaker Change: As far as questions, just on Lunar, what are you saying about the revenue per patient for Atun Lua, and as far as treatment duration, should we think about, you know, kind of the four to five months average?

Speaker Change: And along with that, what are you expecting on timing for Japan approval? And I have a follow-up.

Speaker Change: Ashley Cordova, William Doyle, Asaf Danziger

Speaker Change: Thank you for watching!

Speaker Change: Japan. So we are in basically...

Speaker Change: in giving back to their people.

Speaker Change: to continue as before.

Speaker Change: So sorry, was Japan also early 25s?

Speaker Change: We 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 my insight

Speaker Change: Okay, got it. And thanks. And then for my follow-up, in Q3, your reported active patient numbers came in above our estimate across virtually all regions.

Speaker Change: The prescription numbers weren't too far off our model, so that would imply longer treatment duration.

Speaker Change: in those key markets. Can you give any color there as far as what you're seeing on treatment duration, if those are still consistent with what you saw in ES 14, or if that's changed? Thanks.

Speaker Change: Hi, this is Frank speaking. Thanks for, you know, 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.

Speaker Change: You know 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 Change: and so I think you know I wouldn't look at it in terms of just pure growth and duration and really think about it as a continuum along that process and we're committed to improving across the board.

Speaker Change: Thank you for watching!

Speaker Change: Thank you.

Speaker Change: Our next question comes from Jason Bednar of Piper Sandler. Your line is open.

Jason Bednar: Good morning. A lot of congrats to go around to Asaf and Ashley and on the recent FDA approval. Your first question from us is really a

Jason Bednar: kind of two-parter, I guess, related to the long approval.

Jason Bednar: 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. I know this is going to build over time, but maybe can you help us with how you're internally thinking about

Jason Bednar: you know, the ramp of uptake in terms of treating physicians or the number of physicians you're going to be onboarding, the number of scripts or patients that maybe you might expect in the first year of your launch. Is there anything you're willing to share there? And then just, yeah, and I don't want to get too far ahead of ourselves, but streets modeling 10 million in revenue from lung

Jason Bednar: for 2025. Is that a number that you're comfortable with or you're willing to bless today?

Frank: Jason, this is Frank again. Thank you for the question. You know, just in terms of our approach to the launch, I'll reiterate some things that we said before.

Frank: 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 was conducted and it gives us a really good platform to engage physicians.

Frank: Two 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, in metastatic platinum failure disease.

Frank: 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 tumor treatment fields into their practice.

Frank: We really want to work on then finding the right patients for them, those patients who can succeed on the therapy.

Frank: And then lastly, I think it comes down to the right time. So it's right physician, right patient, and right time. And 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.

Frank: process in place with our physicians to capture patients as they move to, you know, as they see disease progression immediately.

Frank: And so really the message for the coming year is, you know, right physician, right patient, right time. And, you know, I'll say that, you know, we think...

Speaker Change: While we don't give specific guidance, I'd say I think that translates over to that focus on good execution rather than a maximal revenue effort.

Speaker Change: Can you talk about in what ways this might be similar or different to what you established with GBM several years ago when we worked to get payer coverage for a new indication then?

Speaker Change: 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 Change: Yeah absolutely so let me answer the question specifically and then I'll give some color which is you know we we broadly anticipated it will take one to two years to achieve broad reimbursement coverage.

Speaker Change: You know, 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. is going to be on accepting patients who meet the

Speaker Change: The goal is to meet the label and meet the profile of patients in the clinical trials and then begin working with the payers over the 1-2 years to get success. We're not going to specifically target one payers segment population.

Speaker Change: Thank you for watching.

Speaker Change: Okay, right to think that you start commercial, then go Medicare, do you need to, sorry, just to maybe follow up, do you need a certain base or

Speaker Change: size or scale of commercial before you expect Medicare to provide full coverage?

Speaker Change: Well, Jason, this is where I'd anchor back to the one to two years to just, I'd think about the total population and the total effort as something that will play out over one to two years.

Speaker Change: Okay.

Jason Bednar: All right, got it. Thank you.

Speaker Change: Thank you. Thank you.

Speaker Change: Our next question comes from Jonathan Chang of Learink Partners. Your line is open.

Jonathan Chang: Hi guys, thanks for taking the questions

Jonathan Chang: 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 Optum's lung cancer regulatory review in Germany, and do you expect to get a similarly broad label as with the U.S.? Thank you.

Ashley Cordova: Hi Jonathan, this is Ashley. Maybe I'll start with the first question and then hand it over to Asaf for an update on the PEV process. So, I mean, zooming out, no major has been, since the beginning, focused on bringing tumor treating fields to patients with aggressive forms of cancer. That will not change.

Ashley Cordova: 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.

Ashley Cordova: We need to have a successful launch and then we need to deliver on our pipeline. So I would say broad strokes. I will very much be focused on making sure that we have pull-through on those strategic pillars.

Ashley Cordova: I'll continue to put more fine-toothed 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 it.

Ashley Cordova: And regarding the CMR...

Ashley Cordova: Basically, there are no updates since last quarter.

Ashley Cordova: And we are waiting and anticipating that you receive this email.

Ashley Cordova: I'm

Speaker Change: Understood. Thank you.

Speaker Change: Thank you.

Speaker Change: Our next question comes from Emily Bodnar of H.C. Wainwright. Your line is open.

Emily Bodnar: Hi, good morning. Thanks for taking the questions and also my congratulations as well. I'm curious about what your approach to marketing in lung is for particularly patients who've 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 options to patients who are PD-1 experienced.

Emily Bodnar: And then if you can provide any timing on potential data for Lunar 2 and Lunar 4 studies. Thank you.

Emily Bodnar: Hi, this is Frank again. So, to talk about the strategy in terms of the launch and the engagement with physicians, I think, you know, number one, again, I'll go back to the fact that we're very pleased with the label that we've received.

Emily Bodnar: which does allow us to have tumor treating fields used concurrently with a new checkpoint inhibitor.

Emily Bodnar: And, you know, what I'll say again is that we do see in discussions with physicians, there's a clear recognition of an unmet need, because these are patients who are post platinum failure, do not have a driver mutation.

Emily Bodnar: and you really have not seen any improvement in survival in the last eight years. So there's sort of a clear need to deliver better care to that patient population.

Emily Bodnar: You know, 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 LUNR trial and an investigator now in our LUNR2 trial.

Emily Bodnar: and 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.

Emily Bodnar: So, you know, what I'd say is that our initial experience has been really strong engagement with physicians and, you know, as we get a little bit further into the launch, we would probably feel more comfortable commenting on which patients they're selecting. We're literally two weeks into this right now.

Emily Bodnar: You know, 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.

Emily Bodnar: And Emily, this is Nicholas.

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,

Nicholas: We are excited about that, and in terms of trials, we are recruiting in Lunar 2 and Lunar 4, and you can imagine, I cannot give you clear numbers, but we feel, you know, the momentum among the investigators.

Speaker Change: Okay, great. Thanks so much.

Speaker Change: Thank you.

Speaker Change: Thank you. Bye.

Speaker Change: Our next question comes from Jessica Fye of J.P. Morgan. Your line is open.

Jessica Fye: Hey guys, good morning. Thanks for taking my questions. If PANOVA-3 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?

Jessica Fye: And then second, you mentioned the next-gen arrays could be a headwind to gross margins in the future. Can you just give us a sense of the magnitude there? Thank you.

Speaker Change: Ashley Cordova, William Doyle, Asaf Danziger

Speaker Change: So that's what I would include, too, for PNOVA 3 as well as all of our clinical trials.

Speaker Change: that that can ever when we

Speaker Change: And this week with the Headwinds report. Thank you Susan.

Speaker Change: I would expect...

Speaker Change: growth 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.

Speaker Change: Remember, where we will be treating patients ahead of reimbursement in the first couple of quarters to remain in the 70s and, you know, as long as it's going really well, you're going to have a lower 70 number, you're going to be more towards the mid, you know, if we haven't.

Speaker Change: less rapid uptake would look. So it is actually far more dependent on the net revenue participation 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 Change: Zooming out, I would say over the course of the next six quarters, six to eight quarters, we would expect all of that to wash out. We'll be back in March as we're looking at today.

Speaker Change: Thank you.

Speaker Change: Thank you.

Speaker Change: Thank you. Thank you.

Speaker Change: Our next question comes from Vijay Kumar of Evercore ISI. Your line is open.

Speaker Change: Hi, this is Kevin on floor VJ. Just a question on the reimbursement pathway for lung cancer. 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 Change: And how should we think about

Speaker Change: some of the barriers towards reimbursement in the U.S. Thank you.

Speaker Change: Hi, thank you for the question. This is Frank. I would say, you know, 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 one to two years.

Speaker Change: 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...

Speaker Change: have multiple different pathways to approach them to request coverage. I 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.

Speaker Change: There are multiple pathways to get to the end, and really just think about it as a one to two year program in totality, and we'll give updates as we have more specifics.

Speaker Change: Thank you.

Speaker Change: Thank you. I'm showing no further questions at this time. I'd like to turn it back to Bill Doyle for closing remarks.

Bill Doyle: So let me thank you all for your continued interest in our progress at Novicure.

Bill Doyle: When we entered this year, 2024, we stated both externally and internally three clear goals.

Bill Doyle: Grow GVM, Deliver on the Promise of our Pipeline, and Launch Love.

Bill Doyle: Here, as we report Q3, I'm very pleased that we've made

Bill Doyle: Significant and important progress on all three.

Bill Doyle: We're delighted to report 22% top-line growth year-over-year.

Bill Doyle: We have a long list in terms of delivering on our pipeline starting with

Bill Doyle: The MEDIS successful readout, FDA providing breakthrough designation.

Bill Doyle: Of course, the FDA approval of loaner with the broad label that we had sought.

Bill Doyle: and then the LPI, the last patient's in for both trident earlier in the year and this quarter, Pinovo IV, and then initiating the important trial of Keynote C 58.

Bill Doyle: 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,

Bill Doyle: From a commercial perspective, launch low. And as Frank described, we were prepared and we launched the day after receiving FDA approval and have received our first prescriptions.

Bill Doyle: So, it's been a great year and a great quarter of achievement.

Bill Doyle: I am going to end by thanking Asaf.

Speaker Change: I must admit, for me personally, it's bittersweet.

Speaker Change: He deserves retirement.

Speaker Change: He spent two years planning to position Novacure in the strong position that we're in.

Speaker Change: But I'm going to miss it.

Speaker Change: And with that.

Speaker Change: Thank you very much.

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

Speaker Change: Thank you for watching!