Earnings Call Transcript - NVCR Q3 2024

Operator, Operator

Good morning, and thank you for joining us to review NovoCure’s third quarter 2024 performance. I am on the phone this morning with our Executive Chairman, Bill Doyle, our CEO, Asaf Danziger, and our CFO, Ashley Cordova. Other members of our executive leadership team will be available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.novocure.com, on 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 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-K 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.

Bill Doyle, Executive Chairman

Thank you, Ingrid, and good morning. At NovoCure, our mission is to extend survival in some of the most aggressive forms of cancer. Our efforts have focused largely on glioblastoma, but with the recent approval of Optune Lua for non-small cell lung cancer, we are launching our next large indication. Launching tumor treating field 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 third quarter financial performance. Two weeks ago, the FDA approved our PMA for Optune Lua to treat post-platinum metastatic non-small cell lung cancer together with either an immune checkpoint inhibitor or docetaxel. As you know, TTFields 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 have 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 TTFields 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 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. This 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, Asaf Danziger. Asaf 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 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 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. Ashley Cordova embodies all of these characteristics. Ashley has been integral to scaling NovoCure’s global operations and infrastructure since joining the company in 2015. 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 Brackmann 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 Paravasthu took over as our COO, following the retirement of Wilco Groenhuysen. 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 Asaf.

Ashley Cordova, CFO

Thank 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 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 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. This quarter, we also completed enrollment in our Phase 2 PANOVA-4 trial, which adds Roche's immune checkpoint inhibitor atezolizumab to tumor-treating field therapy, gemcitabine, and nab-paclitaxel for the treatment of metastatic pancreatic cancer. As a reminder, PANOVA-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 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. 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 METIS data showed patients treated with tumor-treating field 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 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 3 LUNAR-2 and Phase 2 LUNAR-4 trials. LUNAR-2 is studying tumor-treating fields together with platinum chemotherapy and pembrolizumab in the first line. LUNAR-4 is studying 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 and non-small cell lung. We also have two ongoing Phase 3 trials in GBM, TRIDENT and KEYNOTE D58. The Trident trial is studying the benefit of starting Optune Gio 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 GBM 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 GBM. 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 billing. 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. Gross 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 lung cancer indication to be headwinds to growth margin. 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. 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 $0.28 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.

Asaf Danziger, CEO

Thank you, Ashley. When I joined Professor Palti, NovoCure was a company of a few people in a preclinical lab, working to bring TTFields therapy to the fight against cancer. 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, and I know NovoCure 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 NovoCure to the next level. Ashley has been integral to NovoCure's evolution, from a small company to a 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. 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.

Operator, Operator

Thank you. Our first question comes from Larry Biegelsen of Wells Fargo. Your line is open.

Unidentified Analyst, Analyst

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

Asaf Danziger, CEO

Yes.

Unidentified Analyst, Analyst

First, a thoughtless congratulations on your retirement. Well deserved. As far as questions, just on LUNAR, what are you saying about the revenue per patient for Optune Lua? And as far as treatment duration, should we think about the 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.

Ashley Cordova, CFO

Wait, this is Ashley. I'll jump in just quickly with the first question. We would expect the pricing per patient to be in line with the Optune Lua pricing, and you are right. That's a 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.

Asaf Danziger, CEO

Japan. So we are basically starting our discussion with the NDA. And we're in progress, and we would expect to continue.

Unidentified Analyst, Analyst

So, sorry, was Japan also early ‘25?

Ashley Cordova, CFO

We haven't given the 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.

Unidentified Analyst, Analyst

Okay. 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. 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're seeing on treatment duration, as those are still consistent with what you saw in EF-14, or if that's changed? Thanks.

Frank Leonard, Analyst

Hi Liz, this is Frank. I appreciate your comments on the active patient growth in all our markets. We are extremely proud to have surpassed 4,000 patients on therapy for the first time. I want to highlight something Ashley mentioned, which is our emphasis on the entire patient journey. This involves not only focusing on the duration of treatment but also assisting more patients in transitioning from prescription to starting the therapy. Therefore, I wouldn't frame it merely as growth in duration; rather, it's about viewing it as a continuous process. We are dedicated to making improvements at every step.

Unidentified Analyst, Analyst

Thank you.

Operator, Operator

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

Jason Bednar, Analyst

Hey, good morning. A lot of congrats to go around to Asaf 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 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 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 for lungs for 2025, is that a number that you're comfortable with or you're willing to bless today?

Frank Leonard, Analyst

Thank you for the question, Jason. I'm happy to share our approach to the launch. First, we are very pleased with the broad label we have, which aligns well with our trial and provides a strong platform to engage physicians. We're focusing our launch on the significant unmet medical need in patients who are experiencing platinum failure in metastatic disease. Our priority right now is to have our teams meet with motivated physicians who are interested in incorporating tumor-treating fields into their practice. We aim to help these physicians find the right patients who will benefit from the therapy. Timing is crucial, so we want to ensure we're identifying the right physician, right patient, and right time. The best outcomes for tumor-treating fields occur when treatment begins as early as possible. We are working with our physicians to capture patients as soon as they experience disease progression. Moving forward, our focus is on the right physician, right patient, right time. Although we do not provide specific guidance, this focus will translate into strong execution rather than aiming for maximum revenue next year.

Jason Bednar, Analyst

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?

Frank Leonard, Analyst

Absolutely. To address your question directly, we generally expect it will take one to two years to secure widespread reimbursement coverage. We anticipate that we will likely see more success with private payers first before progressing to the original Medicare fee-for-service program. Our primary focus in the U.S. will be to accept patients who fit the criteria specified in our label and align with the profiles of those in our clinical trials. During the one to two-year period, we'll engage with payers to achieve reimbursement success. We do not plan to concentrate on any specific payer segment over others.

Jason Bednar, Analyst

Okay, but is it correct to assume that you begin with commercial coverage and then proceed to Medicare? Do you need a certain base, size, or scale of commercial coverage before you can expect Medicare to provide full coverage?

Frank Leonard, Analyst

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

Jason Bednar, Analyst

Okay, got it. Thank you.

Operator, Operator

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

Jonathan Chang, Analyst

Hi guys, thanks for taking the questions. First question on the plan 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 review in Germany? And do you expect to get a similarly broad label as with the U.S.? Thank you.

Ashley Cordova, CFO

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 key process. So, I mean, zooming out too much, NovoCure has been 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 GBM. We need to have a successful launch lung 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. I'll continue to put more fine-tuned 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.

Asaf Danziger, CEO

There are no updates regarding the CMO since last quarter, and we are waiting to receive the upcoming updates.

Jonathan Chang, Analyst

Understood, thank you.

Operator, Operator

Thank you. Our next question comes from Emily Bodnar of H.C. Wainwright. Your line is open.

Emily Bodnar, Analyst

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 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.

Frank Leonard, Analyst

Hi, this is Frank again. So to talk about the strategy in terms of the launch and the engagement with physicians, I think number one, again, 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, there's a clear recognition of an unmet need because these are patients who are post-platelet failure, do not have a driver of 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. 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.

Nicolas Leupin, Analyst

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 the momentum among the investigators.

Emily Bodnar, Analyst

Okay, great. Thanks so much.

Operator, Operator

Thank you. Our next question comes from Jessica Fye of JPMorgan. Your line is open.

Jessica Fye, Analyst

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.

Ashley Cordova, CFO

Thanks, Jess. This is Ashley. I'll address those questions. I would reference industry standards regarding the timeline from data collection to approval. Typically, it takes one to two quarters to prepare the necessary package, followed by an expected review period of around 9 to 12 months. This timeline applies to PANOVA-3 and all our clinical trials. Regarding gross margins, I anticipate that they will vary based on our net revenue per active patient, which is significantly impacted by the success of our lung cancer launch. Initially, we will be treating patients before receiving reimbursement in the first few quarters, aiming for gross margins in the 70s. If the lung launch performs well, we may see a lower 70 percentage; otherwise, we could lean towards the mid-70s if uptake is slower. Therefore, our gross margin will be largely influenced by the net revenue per active patient rather than costs. We have discussed the cost pressures from launching our next-gen array, but those effects should subside relatively quickly. In a few quarters, we should return to a more optimized manufacturing price point. Looking ahead, I expect that over the next six to eight quarters, all of these factors will balance out, based on our current perspective.

Jessica Fye, Analyst

Thank you.

Operator, Operator

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

Unidentified Analyst, Analyst

Hi, 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? And how should we think about some of the barriers towards reimbursement in the U.S.? Thank you.

Frank Leonard, Analyst

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 get updates as we have more specific.

Unidentified Analyst, Analyst

Thank you.

Operator, Operator

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, Executive Chairman

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 lung. 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. And then the LPIs, the last patients in for both TRIDENT earlier in the year and this quarter, PANOVA-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 NovoCure in the strong position that we're in. But I'm going to miss him. And with that, thank you very much.

Operator, Operator

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