NovoCure - Q1 2024

Transcript

Moderator (participant)

Thank you for standing by. Welcome to the Novocure Q1 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 one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one 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.

Ingrid Goldberg (VP of Investor Relations)

Good morning, and thank you for joining us to review Novocure's first quarter 2024 performance. I'm joined this morning by 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, and on our Investor Relations page under Quarterly Report. 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 for 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 by developing and commercializing our innovative therapy, Tumor Treating Fields. Over the last two decades, we have established TTFields mechanism of action, developed and improved the TTFields delivery technology, completed multiple successful phase III clinical trials, treated over 30,000 commercial patients, and built an innovative business model. We entered 2024 ready to build on this foundation, and I'm pleased to report our progress today. In March, we announced that our METIS phase III clinical trial, studying the benefits of treating brain metastases from non-small cell lung cancer with TTFields therapy, met its primary endpoint, providing a statistically significant extension in time to intracranial progression.

Later this year, we expect FDA, PMA, and EU CE mark approvals for TTFields therapy in metastatic non-small cell lung cancer post-platinum progression, and an FDA PMA supplement approval for our next generation arrays for GBM. Toward the end of 2024, we will announce top-line data from our phase III trial in locally advanced pancreatic cancer. 2024 is an exciting year for Novocure, with many milestones. I am incredibly grateful for the hard work of our colleagues and for the dedication of our patients and prescribing physicians. On today's call, we will begin with a review of our commercial business in GBM. We will then discuss clinical trial updates from the quarter, and we will close with a discussion of our Q1 financial results before opening the line for questions. In the first quarter at Novocure, we continued our steady pace of execution.

We finished Q1 with 1,643 new prescriptions and 3,845 active patients on therapy. Both are global records for our organization. Our global commercial team is focused on all levers of active patient growth, including prescriptions, patient starts, and long-term compliance and persistence. We believe each input is critical to achieving the best outcomes for patients, which in turn, we believe will drive sustainable growth. We also believe product development enhancements can drive improved patient outcomes. As a reminder, last year, we successfully introduced our next generation arrays in several European countries, and our PMA supplement for the new arrays was filed with the FDA in December. The new arrays are lighter, thinner, more flexible, and leverage new materials to improve the patient experience. New patents have been filed in our key markets to protect the improved designs.

In the U.S., our teams are focused on increasing awareness of the benefits of TTFields therapy among potential patients and prescribing physicians. Last month, we launched a direct-to-consumer campaign, I Power My Life. Our new print and digital assets and our first-ever direct-to-consumer television advertising campaign are key to our efforts to grow our GBM business. Through connected television, which reaches most U.S. households, we are educating potential patients and caregivers about Optune Gio. We believe direct-to-patient messaging will raise awareness of TTFields therapy and strengthen the demand from patients following diagnosis. As we look ahead, one of our key objectives in 2024 is to successfully gain approval and launch Optune Lua for patients with non-small cell lung cancer. We have filed regulatory submissions in our major markets. In January, the FDA formally accepted our PMA for filing.

We recently completed our 100-day meeting with the FDA, a critical milestone for any PMA submission. The 100-day meeting was productive, and there was no indication that the LUNAR PMA will be referred to a panel. Outside the U.S., we are awaiting a CE mark decision in Europe and are in substantive discussions with Japanese regulators. Pending regulatory approvals, our teams are focused on launch preparation. In both the U.S. and Germany, we have hired and trained our thoracic sales teams, including territory managers, clinical educators, and patient experience teams. Within the organization, we are preparing for the opportunities ahead. Our teams are developing marketing materials and field team training assets, preparing HCP certification resources, assembling materials for future thoracic speakers bureaus, planning for thoracic congresses, and training internal support teams. We are prepared to hit the ground running.

We plan to treat patients in Germany and the U.S. immediately following approval, using a named patient reimbursement process, similar to the way we launch treatment for GBM in these countries. Our teams are eager to support another large indication and hope to treat many more patients in the coming months. I will now pass the phone to Asaf to share more regarding our clinical pipeline update.

Asaf Danziger (CEO)

Thank you, Bill. In Q1, we made strong progress advancing our clinical pipeline in three main indications. I will start with METIS. In March, we announced our phase III METIS trial. METIS primary endpoint, marking our latest positive phase III clinical trial. As a reminder, METIS studied TTFields therapy with supportive care for the treatment of brain metastases from non-small cell lung cancer, following stereotactic radiosurgery. Patients in the TTFields therapy arm achieved a 21.9-month median time to intracranial progression, compared to 11.3-months in the control arm. The results were statistically significant, with a p-value of 0.016. The hazard ratio was 0.67. Patients treated with TTFields therapy experienced sustained neurocognitive function and quality of life without an increase in systemic toxicity. The METIS results are very meaningful to physicians, patients, and caregivers.

Many thousands of non-small cell lung cancer patients suffer from brain mets each year. Their prognosis is poor and typically involves rapid neurocognitive decline, with devastating effects on quality of life factors such as motor skills, speech, mood, and cognitive ability. Today, there is limited innovation or studies in brain metastases. The only treatment options are stereotactic radiosurgery, which has risk of continuous relapse, and whole brain radiotherapy, which risks major neurocognitive toxicity. For this patient population, TTFields' ability to significantly extend the time to intracranial progression, delay the need for repeat SRS, and sustain neurocognitive function without increasing systemic adverse events offers major benefit. Key opinion leaders have validated our enthusiasm for the METIS results.

Last week, we were pleased to announce that the METIS trial has been accepted as a late breaking session at the 2024 ASCO annual meeting and will be presented in Chicago on Monday, the third of June. The METIS presentation was submitted and accepted by ASCO long after the standard congress deadlines, validating our belief in the clinical relevance and interest in the study. I would like to express my thanks to the investigators and patients involved in METIS, as well as our Novocure team, who supported the planning and execution of the trial. This quarter, we also announced that our INOVATE-3 phase III clinical trial results were selected as the Best Oral Presentation at ESGO 2024. INOVATE-3 studied TTFields therapy together with paclitaxel in platinum-resistant ovarian cancer.

Results from an exploratory subgroup analysis that showed pegylated liposomal doxorubicin or PLD-naive patients treated with TTFields therapy and paclitaxel saw a significant improvement in overall survival compared to PLD-naive patients treated with paclitaxel alone. Of the 558 total patients enrolled in the INOVATE-3 clinical trial, 201 patients were PLD-naive. Overall survival in PLD-naive patients randomized to receive TTFields therapy and paclitaxel was 16 months, compared to 11.7-months in PLD-naive patients randomized to receive paclitaxel alone. In the PLD-naive subgroup, baseline demographics were similar across both cohorts. This analysis may help to explain the potential survival benefit previously reported in INOVATE-3 patients who received only one prior line of therapy. Novocure is exploring the effects of doxorubicin on tumor tissues and the potential consequences on TTFields dose.

We believe these findings will contribute to a deeper understanding of our mechanism of action and inform future trial designs. Finally, within our GBM program, we completed enrollment of the TRIDENT trial, studying overall survival when Optune Gio is started with chemoradiation compared to starting after chemoradiation. The FDA approved our IND for KEYNOTE-D58, a phase III clinical trial studying overall survival of newly diagnosed GBM patients treated with TTFields, temozolomide, and pembrolizumab. The KEYNOTE-D58 trial builds upon promising clinical data from the 2-THE-TOP phase II trial and extensive preclinical research published in JCI. We accomplished a lot this quarter. I would like to reiterate my gratitude to the team. I look forward to our future reports on our milestone-filled 2024. Ashley will now share details of our first quarter financial performance.

Ashley Cordova (CFO)

Thank you, Asaf. The first quarter was a period of consistent execution, with commercial and regulatory progress, launch preparation, and important clinical readouts. We generated $139 million in net revenues in the first quarter, up 13% year-over-year, and ended the quarter with 3,845 active patients on therapy, up 11% year-over-year. Revenue growth was primarily driven by our successful launch in France and improved approval rates in the U.S. for both current and 2023 periods. Gross margin for the first quarter was 76%. SG&A expenses were $95 million this quarter, up 2% year-over-year. The modest increase in sales and marketing expenses was driven by sales force expansion and increased marketing activities in anticipation of a potential launch in non-small cell lung cancer.

These investments were partially offset by lower personnel expenses within G&A. R&D expenses for the quarter were $52 million, down 14% year-over-year. The decrease was driven primarily by lower personnel expenses and the timing of activities within our ongoing clinical trial portfolio. Our net loss for the first quarter was $39 million, or $0.36 per share, and Adjusted EBITDA was -$5 million, an increase of $14 million compared to the first quarter of last year. The increase in Adjusted EBITDA was primarily driven by revenue growth and an associated increase in gross margin. Actions taken during the November 2023 restructuring and a heightened focus on driving operational efficiencies reduced total operating expenses, excluding share-based compensation, by $2 million year-over-year.

We intend to take actions that prioritize growth and maintain financial health and flexibility as we position Novocure for future profitability. Cash and short-term investments totaled $870 million as of March 31st, 2024. This morning, we announced that we have entered into a new 5-year senior secured credit facility with affiliates of Pharmakon Advisors for up to $400 million. The first $100 million tranche was issued at closing, and the second $100 million tranche will be issued by June 30th, 2025. An additional $200 million is available to be drawn across two tranches at Novocure's discretion and subject to certain milestones through March 2026. The proceeds will be used to settle upon maturity Novocure's convertible notes and to fund working capital needs stemming from Novocure's anticipated launch in non-small cell lung cancer.

The full terms of the deal are outlined in today's 10-Q. Importantly, with this transaction, we have strengthened our cash position and further solidified our balance sheet with non-dilutive capital. With a number of exciting milestones on the horizon, this multi-tranche delayed draw debt facility provides us with valuable balance sheet flexibility. At Novocure, we appreciate the importance of balancing both growth and profitability, and we have a watchful eye on achieving both objectives. I'd like to close today by highlighting one of our Optune Gio users, Kelvin "Doc" Sinclair of Sacramento, California. Doc is a man of many passions. He composes music, collects minerals, raises koi, and operates a bodybuilding gym from his home. Most of all, he enjoys spending time with his wife, Tara, and his three children and seven grandchildren.

In February 2022, Doc was diagnosed with glioblastoma, and after discussions with physicians and considerable research, Doc decided Optune Gio was right for him. Optune Gio has helped Doc continue an active lifestyle without having to sacrifice his numerous hobbies. It's people like Doc who remind us why we do what we do and what it means to extend patient survival in aggressive cancers like glioblastoma.

We have an exciting slate of potential catalysts approaching. The METIS data presentation at ASCO, upcoming regulatory decisions for the LUNAR CE mark in Europe, and the PMA submission in the US, the PMA supplement for new arrays, and finally, top-line data from our phase III PANOVA-3 trial in pancreatic cancer. Our teams are heads down and focused on execution, and we look forward to updating you throughout the year. With that, I'll hand it back to the operator for questions.

Moderator (participant)

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for our first question. Our first question comes from Jason Bednar of Piper Sandler. Your line is open.

Jason Bednar (Managing Director and Senior Research Analyst)

Hey, good morning. Congrats on the results here today, team. I wanted to first start on non-small cell. Good to hear that you don't think you'll face an advisory committee panel. That is a good sign. Are there any other items you can share from your 100-day meeting with the FDA? Any feedback or early indication the FDA has given you on the submission? And then kind of related, I know you've been hoping to get CE mark here ahead of PMA approval. So just similar to my question on the FDA interactions, anything you can discuss with respect to your conversations with the regulatory body in Europe?

Asaf Danziger (CEO)

So good morning, and thank you for the question, it's Asaf. So the one-on-one meeting was a very productive meeting. And you know, we review mainly the labeling and making sure that it's put in the right place. And we're expecting to continue interaction with the FDA. And then as you mentioned, you know, we do believe that we will not have a panel meeting. Regarding the European, we continue our discussion with the regulator, and we basically it's all—it's ongoing discussion, which we're expecting by the first half of this year to get to see.

Jason Bednar (Managing Director and Senior Research Analyst)

Okay, so no change in the CE mark timeline. That's still, you know, here within the next couple of months. That's good. Yeah, the launch in France clearly going very well. It seems to be driving a lot of upside here. You know, script and active patient growth is accelerating. That should be another good leading indicator of what's possible as you look to some other international markets. I didn't hear any other updates today, but, you know, will we see a commercial launch this year? Or kind of where do you stand with your plans for some of the other major European markets where you don't currently have a presence?

Frank Leonard (Chief Development Officer)

Jason, thank you for the question. This is Frank. Yeah, we're very first, I just would reiterate that we are very pleased with the progress we've made in France and how we opened the market and conducted the launch. You know, as you can see in the numbers, we're seeing France size up to be around a Germany-sized opportunity in terms of revenues. We continue to work on additional markets. We kind of will give updates on those markets as they become we have line of sight on specific milestones that we can pass along. So, no direct updates right now, but we do continue to look for those additional opportunities.

Jason Bednar (Managing Director and Senior Research Analyst)

All right. Maybe one quick follow-up there, and then one other housekeeping one for Ashley. Just Frank, I guess any timelines you're willing to share or markets that you're prioritizing? Again, just trying to get a sense of this is something that's maybe, you know, coming later this year, next year, and again, which markets to think about. And then, Ashley, you know, apologies, it's a busy morning here with a lot of reports. I haven't really had a chance to go through the full debt terms, but can you help us with the rate you're paying on the debt? And then I wanna confirm that you're planning to settle the convert fully in cash when it comes due next year. Is that the plan?

Frank Leonard (Chief Development Officer)

So, Jason, this is Frank again. I'll answer on the markets question first. So again, we're not going to provide specific timelines today, but I think in terms of markets, you know, we've said before, we're looking at the big markets in Europe, so obviously working multiple different areas, but Italy and Spain are both in that mix, and as we get closer to real milestones, we'll pass those along.

Ashley Cordova (CFO)

Jason, I'll just do clean up on your housekeeping, so thanks for the question there. I'll remind everybody, we did announce this morning that we have signed a new 5-year senior secured credit facility with Pharmakon. These are partners we know well. It is a $400 million facility, 200 of which we are committed to draw, 100 of which we drew this morning, and 100 of which we will draw in June next year, and 200 of which we have to draw at our discretion. The terms are SOFR plus 6.25, so it is a floating rate facility there, and our anticipation is that full use of proceeds will be to settle the convertible notes when they become due in November 2025, and fund our working capital needs in non-small cell lung cancer.

We believe this is sufficient to fully remove any cash overhang related to the settlement of those convertible notes, so we're now kind of eyes ahead, looking at a balance sheet that will carry us through our strategic plan.

Jason Bednar (Managing Director and Senior Research Analyst)

Perfect. Thanks so much. Congrats again.

Moderator (participant)

Thank you. One moment for our next question. And our next question comes from Jonathan Chang of Leerink Partners. Your line is open.

Jonathan Chang (Senior Research Analyst)

Hi, guys. Good morning, and thanks for taking my questions. Two questions. First, on the METIS study, congrats on getting a late breaker at ASCO. Can you help set expectations ahead of that ASCO presentation?

Nicolas Leupin (Chief Medical Officer)

So Jonathan, good morning. This is Nicolas, and thank you for your question. As you know, METIS is a phase III trial in brain metastases, non-small cell lung cancer, and it comes with a huge amount of data. So we will show the top line results, the initial analysis, because we're still working on it. And for the rest, I would kindly invite you to come and see us in five weeks.

Jonathan Chang (Senior Research Analyst)

Got it. Maybe also second question on the METIS study. On the secondary endpoints, while I appreciate you're limited in what you can say today, are you able to at least help us rule out the possibility that any of the endpoints are trending in the wrong direction?

Nicolas Leupin (Chief Medical Officer)

So I think I'll again direct you to ASCO, but so far we are really excited to show and demonstrate the superiority of TTFields in that area.

Jonathan Chang (Senior Research Analyst)

Understood. Thanks for taking the questions.

Moderator (participant)

Thank you. One moment for our next question. Our next question comes from Jessica Fye of J.P. Morgan Chase. Your line is open.

Na Sun (VP and Equity Research Associate)

Good morning, guys. This is Na Sun on for Jessica Fye. Question on the, when you look at the METIS study and, consider the, commercial opportunity for brain mets, like, given what you've seen from the study, where, where's your current expectation for the sort of peak commercial opportunity, in that indication? And then second, you know, I think it's very interesting that you guys have decided to, go ahead with another, uh, pancreatic indication. Is it, is it driven by what you are seeing in the phase III PANOVA study, that you have decided to start another study in the pancreatic, uh, indication? That's it for me. Thank you.

Ashley Cordova (CFO)

So now, this is Ashley. Maybe I'll start with the market sizing update with the data from IQVIA, and then I'll pass it over to Frank to provide some additional clarity on the commercial opportunity in METIS. I do, for the avoidance of doubt, though, within pancreatic, want to say that we have always had the PANOVA-4 trial ongoing, so that is part of our ongoing pipeline and one we're very excited about and committed to as a part of our long-term strategy, but there's no update there. That's just a, you know, a successful, open and enrolling trial. With regards to the market size for METIS, you know, this is a very significant opportunity.

25% of patients have a brain mets diagnosis, a brain mets at diagnosis of non-small cell lung cancer, and approximately 50% of non-small cell lung cancer patients will develop brain mets at some point over the course of their disease journey. So it is a very large population, but admittedly, it is also a very heterogeneous patient population and a patient population who is having to focus on both treatment of the primary tumor and systemic therapies at the same time as managing the mets. So we are recommending that you take a conservative estimate. There's not a lot of precedent for systemic therapy treatment in brain mets. As we noted, there are few companies that go in this space, so we recommend you are conservative.

In the K, we are, we are recommending that you model 16,000 patients annually in the US as an opportunity set. You know, we'll start there, and then I think we'll be able to, to explore how that can grow, but that's what we're anchoring to for, for your expectations.

Frank Leonard (Chief Development Officer)

Yes, and all... This is Frank. I'll add some color just in terms of what we're hearing from our customers in reaction to the data. It's been a very strong reaction. It's positive in sentiment, and I think, you know, highlight that it was accepted as a late breaker at ASCO. So we've seen the PIs who are a part of the study, as well as some of our customers who treat glioblastoma, reach out with engaged interest here and see this as an area of high unmet need.

Moderator (participant)

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

Kevin Joaquin (VP and Equity Research Analyst)

Hi, this is Kevin on for Vijay. Thanks for taking our question. Just a follow-up question on your meeting with the FDA. Does the FDA typically explicitly indicate the need for an ad hoc panel at these meetings? Is there an opportunity for the FDA to come back and ask for an ad hoc? Thanks.

Nicolas Leupin (Chief Medical Officer)

Thank you for the question. So, you know, the FDA, you know, can do many things, but in principle, when there is a panel, you know, we were in the stage that we were supposed to know about it, and during the meeting, the panel was not mentioned as an option. So, you know, we, we, we still believe that we, well, we will not have a panel.

Kevin Joaquin (VP and Equity Research Analyst)

Got it. On PANOVA-3, the timeline, it looks like the data is now expected in the second half of this year. What changed versus the prior expectation of fourth quarter?

Bill Doyle (Executive Chairman)

Yeah, so nothing's changed. We're in the stage we announced when the trial. This is Bill, by the way. We announced when the last patient was in. This is a trial that's designed to read out 18 months following the last patient in. We are still on track to read out after the data are cleaned. So there's been no change in the expectations for PANOVA.

Kevin Joaquin (VP and Equity Research Analyst)

Thank you.

Moderator (participant)

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

Emily Bodnar (VP of Equity Research)

Hi, good morning. Thanks for taking the questions, and congrats on the progress. I'm curious if you could provide any timing for potential PMA submission based on your METIS study. Then separately, any potential new indications that you're kind of looking to advance into later stage studies now that your, your major phase three studies are kind of coming to an end? Thank you.

Ashley Cordova (CFO)

Emily, I think transparently, it's too soon on both of those points. So the METIS data is very fresh. We're doing the analysis now, looking at a range of options given our current indication footprint and where we would like to go with that disease. So it's simply too soon to comment on timing. We will update you all as we have more news. And I would actually offer that same message on our pipeline. We are committed to executing the pipeline commitments that we shared last year and that strategic prioritization that we shared in November. So that is clearly advancing the GBM, you know, opportunities to extend survival in GBM with our TRIDENT trial and our KEYNOTE-D58 trial that is continuing to invest in lung, and it is also focusing on pancreatic cancer. We know we won't be done there.

This is a platform therapy we believe that has significant broad applicability, but that's what we're focused on today, and we'll come back with further updates as we have them.

Emily Bodnar (VP of Equity Research)

That makes sense. Thanks.

Moderator (participant)

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

Bill Doyle (Executive Chairman)

So thank you, everyone, for joining this morning and your continued interest in Novocure. Q1 was a quarter of real executional progress. We're very pleased with the milestones achieved, including, of course, METIS hitting its primary endpoint and our acceptance as a late breaker to present the first analysis at ASCO. We're very pleased, as Asaf described, with our 100-day meeting at the FDA, and where we stand in the regulatory process, both in the U.S. and Europe. Trident is a very important study for us, and we're pleased that enrollment is complete, and we're now in the timing period to releasing those data.

As always, working with the FDA, when we achieve a milestone like the IND approval for D58, that's a very important milestone in terms of getting that exciting trial that, of course, is based on the 2-THE-TOP data with immune checkpoint inhibitors up and off the ground. And then finally, the financing. You know, we know that we've received a bunch of questions about how we were going to retire the convertible debt that we have on the balance sheet on very good terms. I'll underline, but we think with the financing announced this morning, we will have answered those questions and made it very clear how we intend to proceed in our path to profitability. Big thanks, Asaf.

Thanks to everyone on our team, thanks to our patients and prescribers, and there's a lot more to come in 2024. We look forward to updating you on all the progress in future calls. Have a good day.

Moderator (participant)

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