NovoCure Limited (NASDAQ:NVCR) Q4 2023 Earnings Call Transcript

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Unidentified Analyst: Got it. Okay, thanks. And then my follow-up is, when you announced the odd plan recently, you talked about keeping expenses kind of in check until you reach a breakeven point. Now, when we did the math, we get to something around $700 million or so in total revenue in order for you to reach that breakeven point. And right now, you’re a little over $500 million in total revenue. Can you just talk about, are we thinking about it the right way as far as that $700 million mark, and any color you can provide on timing of that pathway and the drivers? Obviously, its GBM growth and lung, but any additional color on how you get there? Thanks.

Ashley Cordova: I’ll say Lynn, you summarized it very well. Is that what I would say? So you’re on track with your thinking. I would agree with those. We have done the work to make sure that we’re able to scale through that growth on our existing operating expenses and that includes, if we look at the run rate we were exiting Q3 the hiring of the lung board [ph] the cash that we removed out of the business in the back half of the year last year will be able to fund that growth. And then you are correct that that pass to profitability is driven by scale on a top line growth number. So I would say you’ve summarized it well.

Unidentified Analyst: Thank you.

Operator: Thank you. One moment for our next question. And our next question comes from Emily Bodnar of H.C. Wainwright.

Emily Bodnar: Hi, good morning. Thanks for taking the questions. Could you clarify when you’re expecting the CE Mark for second line lung in Europe and how soon after that you think you would be ready to launch? And assuming that you did receive the Europe approval, does that kind of increase your confidence for FDA approval? Thanks.

Asaf Danziger: Thank you for your question. We submit our materials to the regulatory [ph] body in Europe last July and we’re expecting approval in the first half of this year. And what was the other question?

Ashley Cordova: Read through to the FDA.

Asaf Danziger: FDA, we submitted the package for the PMA last December and we received confirmation that it was filed. And we’re just looking forward for the next step, which will be the 100 day meetings, which we expect it to be in the end of March.

Emily Bodnar: Okay. How soon after approval in Europe would you be ready to launch?

Asaf Danziger: We will be ready to launch with the approval.

Emily Bodnar: Okay. So thank you.

Operator: Thank you. One moment. And our final question comes from Vijay Kumar of Evercore ISI.

Unidentified Analyst: Good morning. This is Kevin on for Vijay. One on OpEx levels, you noted a $60 million initiative in terms of OpEx savings. Inclusive of that for the year should we expect OpEx to grow in line with revenues or should we see a step up, given the number of clinical trials? And just to follow-up, what are you expecting for free cash flow in 2024? Thank you.

Ashley Cordova: Yes. So, again, that $60 million is intentional to enable that, we’re fully able to invest in both near-term growth and our long-term priorities. But it also has the happy coincidence of being sufficient to fund the lung launch and the onboarding of our large Phase 3 trials, which we expect to really ramp up this year, principally LUNAR-2 and KEYNOTE D58. So you should expect OpEx levels for the full year 2024 to be largely in line with the full year 2023, given that restructuring that we did and I would say the same statement about cash burn.

Unidentified Analyst: Got it. Thank you. And on your LUNAR program, you noted a meeting with the FDA in mid-March. Do you expect to put out a press release then to let the Street know about your communications with the FDA or would you provide any update in March?

Ashley Cordova: Yes, I mean, we’ll make sure you have the material, relevant information as we have it. The press release would tie to when the FDA has formal public announcements is what I would say.

Unidentified Analyst: Got it. Thank you.

Operator: Thank you. I would now like to turn it back to Bill Doyle for closing remarks.

Bill Doyle: I’d like to start my closing remarks by reiterating my thanks to the NovoCure team for their hard work in 2023 and for the many milestones that were achieved. Our company is bigger, more complex, but our team’s dedication to our mission to help patients with very difficult diagnoses is something of which I am very proud. As exciting as 2023 was, we are looking forward to an even more exciting 2024. As we’ve discussed, we have three fully enrolled Phase 3 trials that will read out to this year and one to follow. We’re rolling our next generation arrays throughout Europe and are really excited [indiscernible] after we get our PMA supplement approval this year and we’re going to launch a non-small cell lung cancer, our next big indication.

It’s extremely busy time, but extremely exciting. So I want to thank everyone on the call today for their continued interest in NovoCure, and we look forward to reporting the results of all of these activities as the year progresses.

Operator: This concludes today’s conference call. Thank you for participating and you may now disconnect.

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