Novocure Ltd

NASDAQ:NVCR

Earnings Call Transcript 2024-Q3

[Operator]

Good day, and thank you for standing by. Welcome to the Novocure Q3 2024 Earnings Conference Call. [Operator Instructions] 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, executive]

Good morning, and thank you for joining us to review Novocure's Third Quarter 2024 performance. I'm 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 noncash 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.

[William Doyle, executive]

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 Fields therapy in non-small cell lung cancer is an important achievement for Novocure. We are eager to bring a new and urgently needed therapeutic option to patients in need.

This morning, we will begin with a discussion of our non-small cell lung cancer approval and launch plans followed by a GBM business review, clinical pipeline update and review of Novocure's third quarter financial performance. 2 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 time lines 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 health care 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 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 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 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 venture of leaders.

When the Board began the process to identify Asaf successor, our goal was to find a candidate with substantial institutional knowledge experience managing and expanding global organization and a deep understanding of our clinical and commercial opportunities. Ashley Cordova embodies all of these characteristics. Ashley has been integral to scaling Novocure's global operations and infrastructure since joining the company in 2014. Her commitment to our patients and strategic vision are exceptional as is her record of accomplishment as our CFO. 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, who's joined Novocure as our next CFO, replacing Ashley in this role. Christophe joins Novocure this week and will assume the CFO position on January 1. 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. is external perspective will be an important addition to our executive team.

Finally, in October, [ Macon Pravas ] took over as our COO, following the retirement of Wilco Greenhouse. 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?

[Ashley Cordova, executive]

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 III PANOVA trial later this year. PANOVA-3 is studying the use of Tumor Treating Fields 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 analysis.

This quarter, we also completed enrollment in our Phase II 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 5 quarters ago and was designed to enroll 76 patients. We are pleased with the excitement and engagement of the pancreatic cancer community around this trial and are eager to better understand the potential of Tumor Treating 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-small 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 METIS 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 Fields 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 inspection. 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-2 and Phase II LUNAR-4 trials. LUNAR-2 is studying Tumor Treating Fields together with platinum chemotherapy and pembrolizumab in the first line. LUNAR-4 is setting treatment with Tumor Treating Fields therapy in 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 Fields therapy and non-small cell loss. We also have 2 ongoing Phase III trials in GBM, TRIDENT and KEYNOTE-B38. 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 2-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 Gio plus temozolomide following chemoradiation. KEYNOTE D58 is an exciting opportunity to build upon the results of the Phase II 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 billings. Looking ahead, we do not expect to see an incremental onetime 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 non-small cell lung cancer indication to the headwinds to gross 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 revenue as well as material benefit 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 retired 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.

I will now turn the call over to him for some parting words.

[Asaf Danziger, executive]

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'm very proud of how far we have come and of the lives we have affected. And I know Novocure is poised for greater things ahead under Ashley's leadership. 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 Instructions] And our first question comes from Larry Biegelsen of Wells Fargo.

[Lei Huang, analyst]

It's Lei a calling in for Larry. Can you hear me okay?

[Unknown Executive]

Yes.

[Lei Huang, analyst]

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 [ Optima ] and as far as treatment duration, should we think about kind of the 4 to 5 months average? And along with that, what are you expecting on timing for Japan approval? And I have a follow-up.

[Ashley Cordova, executive]

Lei, this is Ashley. I'll jump in just quickly with the first question. We would expect the pricing were to be in line with [indiscernible] the pricing. And you are right that the 4 to 5 months is what I would -- that's what we saw in clinical trial. And then until we have more commercial experience that's what we would [indiscernible].

[Unknown Executive]

So we are in basically start our discussion with the FDA and during advanced continue.

[Lei Huang, analyst]

So sorry, was Japan also early '25?

[Ashley Cordova, executive]

We haven't given time lines to what we'll say is that we're in productive discussions, and we'll update as soon as we have line of sight.

[Lei Huang, analyst]

Okay. Got it. And then for my follow-up. Just in Q3, your reported activation numbers came in above our asset across virtually all regions. The prescription or 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, and those are still consistent with what you saw in the [ ES-14 ] if that's changed?

[Frank Leonard, executive]

This is Frank speaking. Thanks for mentioning the occupation growth across all of the active markets. I mean we're incredibly proud to have achieved over 4,000 patients on therapy for the first time. What I'll note is something that Ashley noted in the script, which is that we are focused on the end-to-end patient journey, which includes not just focusing on duration but also helping more patients convert from the time of prescription to a star. And so I think I wouldn't look at it in terms of just pure growth in duration and really think about it as a continuing along that process, and we're committed to improving across the board.

[Operator]

Our next question comes from Jason Bednar of Piper Sandler.

[Jason Bednar, analyst]

A lot of congrats to go around to this half financially and on the recent FDA approval. First question from us is really a kind of a 2-parter, I guess, related to the lung approval, you mentioned some of the next steps here, new launched in the U.S., making sure you're getting prescriptions written for patients that bigger 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 positions 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 -- and I don't want to get too far ahead of ourselves, but Street's modeling $10 million in revenue from lung for 2025. Is that a number that you're comfortable with or you're going to bless today?

[Frank Leonard, executive]

Yes. Jason, this is Frank again. Thank you for the question. I'll talk 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 [indiscernible]. That we think we have a very broad label that fits with how the trial is conducted, and it gives us 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 platinum failure in metastatic platinum failure disease. And so accordingly, what we're really focused on right now is getting our teams in the field to meet with physicians to make sure we have the right highly motivated physicians who are interested in integrating 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 tumors deals having the best potential for a benefit is when you start as early as possible. So we're trying to get process in place with our physicians to capture patients as they move to -- as they see disease progression immediately. And so really, the message for the coming year is right physician, right patient at the right time. And I'll say that we think while we don't give specific guidance, I'd say, I think that translates over to that focus on good execution rather than sort of a maximum revenue effort next year.

[Jason Bednar, analyst]

Okay. 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 time line 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, executive]

Yes, absolutely. So let me answer the question specifically, and then I'll give some color, which is we broadly anticipated it will take 1 to 2 years to achieve broad reimbursement coverage. The way that we'll achieve that will most likely go with better success first with private payers and then moving into the original Medicare fee-for-service program. But our focus in the U.S. is going to be on accepting patients who meet the essential meet the label and meet the profile of patients in the clinical trial and then begin working with the payers over the 2 years to get success. We're not going to specifically target 1 payer segment population on the other.

[Jason Bednar, analyst]

Okay. But right of things that you start commercial then go Medicare, do you need -- sorry, just to maybe a follow-up. Do you need a a certain base or size or scale of commercial before you expect Medicare to provide full coverage? .

[Frank Leonard, executive]

Well, Jason, this is where I anchor back to the 1 to 2 years. So just I think about the total population and the total effort is something that will play out over 1 to 2 years.

[Operator]

Our next question comes from Jonathan Chang of Leerink Partners.

[Jonathan Chang, analyst]

First question on the planned transitions to the management team. Can you talk about how we should be thinking about potential changes in overall company strategy? And second question, can you discuss the latest progress for the Optune's lung cancer regulatory review in Germany? And do you expect to get a similarly broad label as with the U.S.?

[Ashley Cordova, executive]

This is Ashley. Maybe I'll start with the first question, and then we hand it over to Asaf for update on the I mean doing out too much notice has been to begin any focus on bringing tumor treating deals to patients with aggressive part of cancer. That will not change. And when we look at our 2024 objective 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 longer than we need to deliver on our pipeline. So I would say broad stroke, I will very much be focused on making sure that we have pull-through on those strategic pillars. I'll continue to put more into 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.

[Asaf Danziger, executive]

And regarding the CMA, basically, there are no assets since last quarter, and we are waiting and anticipate that we see the same [indiscernible].

[Operator]

Our next question comes from Emily Bodnar of H.C. Wainwright.

[Emily Bodnar, analyst]

I'm curious about what your approach to marketing and long is for particularly patients who have received checkpoint inhibitors in the first-line setting. And what the kind of initial feedback from physicians has been on whether they kind of see benefit in prescribing Optune to patients who are PD-1 experienced? And then if you can provide any timing on potential data for LUNAR-2 and LUNR-4 studies?

[Frank Leonard, executive]

This is Frank Leonard. So to talk about the strategy in terms of the launch and the engagement with physicians, I think, 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 the new checkpoint inhibitor. And what I'll tell you is that we do see in discussions with physicians is a clear recognition of an unmet need because these are patients who are post [indiscernible] failure do not have to drive a mutation and you really have not seen any improvement in survival in the last 8 years. And so there's sort of a clear need to deliver better care to that patient population. .

I saw this personally last week as I was in the field where I had the chance to meet with someone who was an investigator in the LUNAR trial and an investigator now in the 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 -- we would probably feel more comfortable commenting on which patients they're selecting. We're literally 2 weeks into this right now. So again, I just go back to the fact that what we see consistently is a recognition of a high unmet need and then an attempt to figure out the right way to bring it into practice.

[Nicolas Leupin, executive]

Emily, this is Nicolas. I'll take the second part of your question 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.

[Operator]

Our next question comes from Jessica Fye of JPMorgan.

[Jessica Fye, analyst]

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 raise ] could be a headwind to gross margins in the future. Can you just give us a sense of the magnitude there?

[Ashley Cordova, executive]

Yes. Jess, this is Ashley. I'll take those. So I would say anchor to industry norms when we think about time to go from data to approval. What we know is that it takes 1 to 2 quarters to get the page press and then we expect to review time to take another [indiscernible]. So that's what I would be for PANOVA-3 as well as all of our clinical trials. That's PANOVA. When we headwind. Thank you for I would expect gross margin depending on where we land with net revenue per occupation, 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 a is going really well, you're going to have a lower 70 number you're going to be more towards the mid if we have less rate than uptake with long.

So it is actually far more dependent on the net revenue practition that we're able to build and it is on cost itself. We talked about the headwinds from COGS from the launch of our next-generation array, but those will watch 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 6 quarters, 6 to 8 quarters, so we would expect all of that to wash out, and we'll be back in target we're looking at today.

[Operator]

Our next question comes from Vijay Kumar of Evercore ISI.

[Kevin Joaquin, analyst]

This is Kevin on for Vijay. Just a question on the reimbursement pathway for lung cancer. So a 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.?

[Frank Leonard, executive]

Thanks for your question. this is Frank. I would say, again, I'll start with the big picture, which is that we expect the entire process of gaining reimbursement across both private payers and the Medicare program to play out over 1 to 2 years. In terms of the specifics of how we will approach CMS and what steps will happen with CMS, I'm would add the color that we have 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 on how that will play out. And so again, I think I would think about this just in the context that it's reimbursement is always very complex there are multiple pathways to get to the end and really just think about it as a 1- to 2-year program in totality, and we'll give updates as we have specifics.

[Operator]

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

[William Doyle, executive]

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, 3 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 3. 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 LPI, 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 loan 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 taking us off. I must admit for me personally, it's bitter sweet -- it deserves retirement. He spent 2 years planning to position Novocure in the strong position that we're in. But I'm going to miss -- and with that, thank you very much.

[Operator]

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