NovoCure Limited

Good 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 speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Ingrid Goldberg. Please go ahead.

Ingrid Goldberg Good morning, and thank you for joining us to review Novocare's third quarter 2024 performance. I am on the phone this morning with our Executive Chairman, Bill Doyle, our CEO, Asaf Donziger, and our CFO, Ashley Cordova. Other members of our Executive Leadership Team will be available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.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. These statements involve a number of risks and uncertainties, some of which are beyond our control and are described from time to time in our SEC filings. We do not intend to update publicly any forward-looking statement except as required by law. Where appropriate, we will refer to non-GAAP financial measures to evaluate our business, specifically adjusted EBITDA, a measure of earnings before interest, taxes, depreciation, amortization, and share-based compensation. We believe adjusted EBITDA is an important metric as it removes the impact of earnings attributable to our capital structure, tax rate, and material non-cash items and best reflects the financial value generated by our business. Reconciliations of non-gap-to-gap financial measures are included in our press release, earnings slides, and in our Form 8K filed with the SEC today. These materials can also be accessed from the investor relations page of our website. Following our prepared remarks today, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.

Thank you, Ingrid, and good morning. At 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 OptumLua 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 Novacure. 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 Novacure's third quarter financial performance. 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. 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 second line. For months, we've been preparing for this launch. The lung team was hired over the summer and has undergone extensive scientific training. 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. 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. Our 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. We will be launch ready upon approval in both of these important markets. I am incredibly proud of the efforts of our team to bring TT Fields 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. This is an important achievement for patients. As we prepare for a new chapter at Novacure, we are pleased to implement planned changes to our executive team that will position Novacure for long-term success. Last month, we announced the retirement at the end of this year of our CEO, Asaf Danziger. 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. Under Asaf's leadership, we have grown from a small team in Israel to an international company of over 1,400 employees. We 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 a soft 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 Novacure'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. We 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 Christoph Brackman has joined Novocure as our next CFO, replacing Ashley in this role. Christoph joins Novocure this week and will assume the CFO position on January 1st. 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. Christoph was instrumental to Moderna's scale-up during the COVID pandemic. His external perspective will be an important addition to our executive team. Finally, in October, Mukund Parivashu took over as our COO. following the retirement of Wilco Grunhausen. 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 Novacure would not exist today without Asah. Ashley.

Thank you, Bill. It is an exciting time to be at Novacure, 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 patients on therapy, breaking the 4,000 patient threshold for the first time. This 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 fields therapy with gemcitabine and nabpaclitaxel for the treatment of unresectable locally advanced pancreatic cancer. We recently completed patient follow-up and are now finalizing data collection and analyses. This quarter, we also completed enrollment in our Phase 2 Penova 4 trial, which adds Roche's immune checkpoint inhibitor atezolizumab to tumor treating field therapy, gemcitabine, and nabpaclitaxel for the treatment of metastatic pancreatic cancer. As a reminder, Penova 4 was launched in mid-2023, just five 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 fields 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-cell cell lung cancer. As a reminder, we presented data from the Phase III METIS trial at ASCO in June. METIS 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 MEDIS data 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, an expedited review of pre-PMA manufacturing and quality systems compliance inspections. We expect to file the PMA in early 2025. Following on the success of the LUNAR trial in metastatic non-small cell lung cancer are our Phase III LUNAR II and Phase II LUNAR IV trials. LUNAR II is studying tumor-treating fields together with platinum chemotherapy and primrolizumab in the first line. Lunar 4 is studying treatment with tumor-treating field therapy and pomerolizumab 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 lungs. We also have two ongoing Phase III trials in GBMs. Trident and Keynote D58. The Trident's trial is studying the benefit of starting OptumGeo earlier in the patient journey, concurrent with chemoradiation, rather than following chemoradiation. Trident completed enrollment last January, and patients are currently in the two-year follow-up period, with data expected in 2026. 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. Keynote D58 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 GVMs. Turning to our financial performance for the third quarter, top-line growth was strong. Q3 net revenues were $155 million, 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 million in Q3 net revenues from prior period billings. Looking 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. Growth margin in the third quarter was 77% compared to 75% in the third quarter 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. Looking ahead, we expect the global launch of our next-generation arrays as a non-small-cell lung cancer indication to be headwinds to gross margins. 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 GNA. Research and development expenses in the quarter totaled $52 million, a decrease of 3% from the same period in 2023. Our net loss for the quarter was $31 million, or 28 cents per share. 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. 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. I 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.

Thank you, Ashley. When I joined Professor Paltee, NovoQ was a company of a few people in a preclinical lab, working to bring TT field therapy to the fight against cancer. Today, NovoQ 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. And I know NovoQ is poised for greater things ahead under Ashley's leadership. 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. Ashley has been integral to NovoQ'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 walk at NovoQ. Finally, 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.

Thank you. As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. One moment while we compile the Q&A roster. And our first question comes from Larry Beagleson of Wells Fargo. Your line is open.

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

Good.

First, Asaf, just congratulations on your retirement. Well deserved. As far as questions, just on Lunar, what are you saying about the revenue per patient for Atum Lua? And as far as treatment duration, should we think about, you know, kind of the four to five months average? And along with that, what are you expecting on a timing for Japan approval? And I have a follow-up.

This is Ashley. I'll jump in just quickly with the first question. We would expect the pricing to be in line with the opportunity of pricing, and you are right. That's the four to five months is what I would model. That's what we saw in the clinical trial, and until we have more commercial experience, that's what we would anchor you to.

Japan. So we are in basically start our discussion with the CMDA. And we are in advance review with them to continue .

So sorry, was Japan also early 25? We haven't given .

timelines yet, what we'll say is that we're in productive discussions and we'll update as soon as we have my insight.

Okay, got it. And thanks. And then for my follow up, I'm in Q3. So your report of 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. Can you give any color there as far as what you see on treatment duration as those are still consistent with what you saw in ES14, if that's changed? Thanks.

Hi, Liz. This is Frank speaking. Thanks for mentioning the active patient growth across all the active markets. 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 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. And so I think, you know, 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.

Thank you.

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

Hey, good morning. A lot of congrats to go around to Saf and Ashley and on the recent FDA approval. First question from us is really a two-parter, I guess, related to the lung approval. You mentioned some of the next steps here. You'll launch 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, 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 lungs. for 2025, is that a number that you're comfortable with or you're willing to bless today?

Yes. 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. 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, you know, a really good platform to engage physicians. 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 metastatic platinum failure disease. 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-treating 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. 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 a 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, you know, right physician, right patient, right time. And, you know, I'll say that, you know, we think, you know, while we don't give specific guidance, I'd say, you know, I think that translates over to that focus on good execution rather than sort of a maximal revenue effort.

Okay. 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 worked 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?

Yeah, absolutely. So let me answer the question specifically, and then I'll give some color, which is, you know, we've broadly anticipated it will take one to two years to achieve broad reimbursement coverage. 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, you know, original Medicare fee-for-service program. But our, you know, our focus in the U.S. is going to be on accepting patients who meet the, you know, essential meet the label and meet the profile of patients in the clinical trials and then begin working with the payers over the one to two years to get success we're not going to specifically target one payer segment population on the other 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 um a certain base or um

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

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

Okay. Got it. Thank you.

Thank you.

Thank you. Our next question comes from Jonathan Chang of LeeRink Partners. Your line is open.

Hi, 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 Optum's lung cancer regulatory review in Germany? And do you expect to get a similarly broad label as with the US? Thank you.

Hi, Jonathan. This is Ashley. Maybe I'll start with the first question, then hand it over to a software update on the TUD process. So, I mean, zooming out, no picture has been since the beginning focused on bringing tumor-treating fields 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 TBMs. We need to have a successful launch along, and then we need to deliver on our pipeline. So it's a broad stroke. I will very much be focused on making sure that we have pull-through on those strategic pillars. You know, 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, you know, we know what we need to do, and we remain committed to doing it.

And regarding the CMOP, Basically, there are no updates since last quarter, and we are waiting and anticipate that this is the theme coming.

Understood. Thank you. Thank you.

Our next question comes from Emily Bodnar of HC Wainwright. Your line is open.

Hi, good morning. Thanks for taking the questions and all of my congratulations as well. I'm curious about what your approach to marketing and 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 Optune to patients who are PD-1 experienced. And then if you can provide any timing on potential data for Lunar 2 and Lunar 4 studies. Thank you.

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. which does allow us to have tumor-treating fields used concurrently with a new checkpoint inhibitor. And what I'll say again is that we do see in discussions with physicians this clear recognition of an unmet need, because these are patients who are post-flattening failure, do not have a driver mutation, and 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. 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 LUNAR trial and an investigator now in our LUNAR-2 trial. 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. So what I 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 they're selecting. We're literally two 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.

And Emily, 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. And in terms of trials, We're 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.

Okay, great. Thanks a lot. Thank you. Our next question comes from Jessica Phi of J.P. Morgan. Your line is open.

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? 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.

Yeah, Jeff, this is Ashley. I'll take those. You know, 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 one to two quarters to get the package pressed, and then we expect review time to take another nine to 12 months. So that's what I would anchor you to for Panova 3 as well as all of our clinical trials. That's Panova. When we, headwinds to go to target, thank you. You know, 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 be treating patients ahead of reimbursement in the first couple of quarters, to remain in the 70s and, you know, if lung is 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 have a less rapid uptake with luck. 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. 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, and we'll be back in March as we're looking at today.

Thank you. Thank you.

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

Hi. This is Kevin on for Vijay. 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? And how should we think about some of the barriers towards reimbursement in the U.S.? Thank you.

Hi, thank you 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 one to two 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. 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 reimbursement is always very complex. 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.

Thank you.

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

So 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 three clear goals. Grow GBM, deliver on the promise of our pipeline, and launch law. 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 MEDIS successful readout FDA providing breakthrough designation. Of course, the FDA approval of Lunar with the broad label that we had sought. And then the LPI, the last patients in for both Trident earlier in the year and this quarter, Penova 4. And then initiating the important trial of Keynote D58. 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. And 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 thanking Asaf I must admit, for me personally, it's bittersweet. He deserves retirement. He spent two years planning to position Novacure in the strong position that we're in. But I'm going to miss him. And with that, thank you very much.

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