Good day and thank you for standing by. Welcome to the NovoCure Q3 2022 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 Ingrid Goldberg.

Good morning, everyone and thank you for joining us to review Novocure's third quarter 2022 performance. I'm joined on the phone by our Executive Chairman, Bill Doyle; our CEO, Asaf Danziger; and our CFO, Ashley Cordova. Other members of our executive leadership team are also on the call and available for Q&A. For your reference, slides accompanying this earnings release can be found on our website, www.novocure.com, under quarterly reports on our, Investor Relations page. 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 statements, 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 our Investor Relations page on our website. Following our prepared remarks today, we will open the line for your questions. I will now turn the call over to our Executive Chairman, Bill Doyle.

Thank you, Ingrid. And good morning, everyone. At Novocure, our mission is to extend survival in some of the most aggressive forms of cancer through the development and commercialization of our life-extending therapy Tumor Treating Fields. In the third quarter, we consistently executed across our business in service of our mission. Our team is diligently working to reach additional patients in our current markets, expand into new markets, enhance our Tumor Treating Fields delivery systems and treat patients in new indications throughout the body. We made significant advancements in our clinical and product development programs and we are eagerly awaiting data readouts from multiple pivotal trials starting in the first quarter of 2023. Our GBM business remains the core driver of our financial stability and enables us to invest aggressively in a variety of clinical and product development initiatives as well as commercial programs designed to increase adoption. In the third quarter, we generated $131 million in net revenues and $22 million in cash flow from operations. The U.S. market is our largest revenue contributor, in which currently approximately 40% of newly diagnosed GBM patients receive a prescription for Optune. We believe there is room to drive greater adoption of Optune in newly diagnosed GBM given the best-in-class outcomes demonstrated by our EF-14 randomized clinical study, a growing body of basic and translational science from leading academic research centers and ongoing confirmation from real-world evidence analyses throughout the globe. There are 3 key publications that we would like to highlight this quarter. First, a manuscript by Dr. Chirag Patel of MD Anderson Cancer Center which has been accepted for publication in the Journal of Molecular Cell Biology, reviews the multiple distinct mechanisms of action of TTFields. This paper is a comprehensive review of TTFields in a high-impact journal and highlights…

Thank you. I would like to echo Bill's anticipation for the upcoming pivotal readouts. 2023 will be a very exciting year. As a reminder: We currently have 4 Phase III pivotal studies approaching completion. The first to readout will be the LUNAR study evaluating the use of TTFields together with physicians' choice checkpoint inhibitor for the treatment of Stage 4 non-small cell lung cancer following platinum failure. We completed enrollment in this study in the fourth quarter of 2021 which started a 12-month follow-up period. We plan to announce top line results from both the primary and powered secondary end points early next quarter. The next Phase III data readout will be from the INNOVATE-3 pivotal trial. INNOVATE-3 is studying the efficacy of TTFields together with paclitaxel for the treatment of platinum-resistant ovarian cancer. Ovarian cancer is deadly, especially once a patient has become resistant to platinum-based therapy. Enrollment in INNOVATE-3 was completed in October 2021 which started the 18-month follow-up period. Top line results are expected in the second half of 2023. Our next top line data release will be from our METIS study, evaluating TTFields as a monotherapy for the treatment of brain metastases from non-small cell lung cancer. Treatment of brain metastases is a significant unmet need. Brain metastases often go untreated due to the diminished blood-brain barrier permeability of many cancer drugs. METIS continues to enroll well. And we have to final patient enrollment but we will need an additional quarter to reach this milestone. Given the 12-month follow-up period for METIS, we now expect top line results in Q1 of 2024. The final readout from our current slate of Phase III pivotal trials is the PANOVA-3 study, evaluating the use of TTFields together with nab-paclitaxel and in locally advanced pancreatic cancer. The 5-year survival rate…

Thank you, Asaf. The third quarter of 2022 was another period of consistent commercial execution, as the profits from our GBM business continued to finance ongoing investment in clinical development and commercial expansion. Net revenues in the third quarter were $131 million, with $22 million in cash flow from operations. We ended the period with 3,420 patients on therapy. There were several notable headwinds this quarter that impacted net revenues, including the volume of cash collections from aged claims in the U.S., the ongoing impact of German coverage update and FX pressure from both the weakening Japanese yen and Europe. With respect to aged claims in the U.S., we continue to pursue previously denied claims. However, the accessible collections will largely be exhausted this year and the remaining outstanding aged claims will take more time and effort to collect. As we look ahead to 2023, we expect our net revenues to more closely reflect the core drivers, active patients on therapy times the net revenue earned per active patients, times 12 months. Gross margin for the third quarter was 77%. Impact to our gross margin from inflationary pressures have been minimal to date and we are working with suppliers to optimize our cost of revenue. SG&A expenses for the third quarter totaled $74 million, an increase of 16% year-over-year. We are investing aggressively in our commercial capabilities, with multiple future growth levers in mind. These include investments in pre-commercial groundwork for potential launches across multiple cancer indications and the expansion of our international footprint. We invested $52 million in research and development in the third quarter, an increase of 8% from the third quarter of 2021. One of the hallmarks of our therapy is the broad applicability and combinability with numerous treatment modalities and pharmacological agents. We will continue to…

[Operator Instructions] Our first question comes from Greg Fraser with Truist.

I wanted to ask about Germany. When do you expect reimbursement to return to a more normalized level? And how do we think about normalized in terms of net revenue per patient per month?

Greg, this is Ashley. Thanks for the question and for joining the call today. As a reminder: In the second quarter, we disclosed that we had received DME listing in Germany and contracted pricing with all of the large payers. You asked specifically what we should expect in the long term. I'll say our price in Germany is in line with our global ASP, so that's what you should expect us to ramp back up to but we continue to face headwinds to our German net revenues for patients who started prior to coverage and for whom we are no longer being paid. That's consistent with that last quarter but we expect to continue to see an impact for the next 5 quarters or so through the end of 2023. Separately, we reviewed our AR balance this quarter to reflect the updated coverage criteria and that was an additional headwind onetime in the quarter. If we summarize it all, as we mentioned last quarter, with short-term pain for long-term gain as we now have formal listing and established reimbursement pathway and pricing in Europe in line with our global pricing.

Got it. Can you talk a bit more about what you’re seeing in Japan in terms of demand? Prescription volume there has been trending down over the last few quarters. Is there something driving that trend?

This is Pritesh. I'll take that question. Thank you for asking the question. Our business in Japan is strong and growing and we're very pleased to see the active patient trends over -- quarter-over-quarter grow there. Through better physician education, we have transitioned to a model where we are receiving prescriptions for patients that are actually able to start, so we want to improve our ability to impact patients that can actually receive the therapy. And any variability that you see in the prescription is just noise. And I would continue to look at active patients as a measure of our growth in Japan.

Got it. So the fill rate has gone up essentially versus what it used to be.

Yes.

Got it, okay. And can you also talk about expectations for the ramp in France once you finalize reimbursement? Is it fair to look at the experience in Germany, or do you expect faster adoption given that option is more established now?

Yes. Thank you again for that question. So in France, just as a reminder, we're in the process of securing reimbursement and it's too early for us to determine what the ramp-up will be. We're doing everything we can, applying all of our learnings from Germany and other markets to educate the marketplace; prepare our teams to make sure that, as soon as we get the green light, we can start helping patients in France.

One more quick one and I’ll get back in the queue but do you already have patients on treatment now in France that will become paying patients after secure reimbursement?

Yes. So we have patients today that we're treating in France. Those are through clinical trials. Those are the TRIDENT trial that we have ongoing in France. We don't have any commercial patients outside of that in France today.

[Operator Instructions] Our next question comes from Jason Wittes with Loop Capital.

First off, you’re beefing up your infrastructure for GBM sales in the U.S. [indiscernible]. Should we anticipate that you’re going to see some meaningful move on that 40% penetration number next year with these changes, or is this going to be a more gradual slope?

Yes. Jason, this is Bill. I'll start off here. So as you point out and I'll just level set for everyone, the U.S. is our largest and most important market. We have -- we receive approximately 40% prescriptions, meaning we have approximately 40% penetration, in newly diagnosed GBM. We've got Tier 1 recommendation, per the NCCN guidelines. We've established essentially universal pricing and reimbursement for patients in the U.S. And it really is the core driver of our profitable business that's funding all of the other activities that we've discussed. So that's sort of the big picture. We believe there are significant opportunities to increase that 40%. First and foremost is penetration at the academic centers. This is where the ISTs that we've discussed previously; as well as the TTF, the new Tumor Treating Fields campaign that we discussed in the script; and also the power of the academic papers that are now coming from independent researchers that are validating the EF-14 clinical trial. All those are important for our growth. And then, again, we have now streamlined our organization to really focus on driving this. And with that, I'd like to ask Frank Leonard, who's on the call and is our new franchise President. Frank, maybe you could just give a little bit of background on your thoughts in terms of how we're going to drive growth in the U.S.

Thank you, Bill. Yes, we're excited to launch the new CNS franchise. It's a new organization that combines sales, marketing, medical leadership as well as our patient support functions in a single operating unit in the U.S. I think, first and foremost, the creation of the unit ensures that we do maintain the focus on increasing the number of GBM patients receiving Optune while allowing the rest of the organization to prepare for the future. We're really within this new organization focused on 2 key operational changes. First, we want to streamline the decision-making related to the U.S. GBM business to ensure we can get faster implementation of changes that support our prescribers and our patients. Second, we also want to build an organization that can prioritize the strategic objective for growth while decentralizing the tactics and the execution to the teams that are closest to our customers. And I also mention just lastly that -- I want to highlight that we just returned from the ASTRO conference in San Antonio. And as a reminder: ASTRO is the largest conference focused on radiation oncology. And our radiation oncology prescribers are some of our most engaged and confident customers. With over 75 -- 7,500 attendees at the conference, we had 4 days of significant customer engagements face-to-face which we still believe is the best way to engage our customer. And my main takeaway from ASTRO is that the radiation oncology community understands the long-term potential for Tumor Treating Fields both in GBM and in the other solid tumors we're studying. So we had an excited customer base that was eager to talk to us both about applications in GBM as well as aware of the fact that there's upcoming data releases that will be meaningful. Thank you, Bill.

So again, maybe to summarize. We have a very strong foundation in GBM. It is among our highest priorities, to grow in GBM and hence the reorganization to provide that focus. We have significant evidence that continues to build. And while I wish there were a magic bullet that I could fire and would drive immediate growth, I think this growth will build over time but we're committed to getting the therapy to these patients.

Okay, I appreciate all that color. If I could just ask one other question then, on high-intensity. The 25-patient pilot study was pretty impressive. It looks like you doubled progression-free survival. In terms of – it sounds like it will be out officially in Europe this year, from your comments. Can you make any – give us any guidance in terms of how things play out in the U.S. in terms of what the regulatory pathway might be for that?

So sure. So again our focus has been on building -- first of all, developing the arrays, then building the manufacturing infrastructure to supply the array. We made the decision to launch in Europe first which we expect to occur this year. We'll announce that when we do have the first patients on these arrays. And then we'll start the regulatory process in the U.S. next year.

And Jason, just for the avoidance of doubt but EF-33 data is on our 14 another kind of leapfrog generation of high-intensity array that is lighter and more flexible.

Yes. A great point. So we started the first trial with an early design that delivered the high intensities and it -- and we tested those on some of the sickest patients. Again these were recurrent GBM patients and as you point out, we were delighted to see the improvement in overall survival in these patients. We were also delighted to see that there was no toxicity. And for this initial trial, that was -- those were both important end points. And again I'm just repeating what Ashley said, The flex is another step forward that not only delivers the high intensity but is a much more comfortable, lighter, easier-to-use array; and so we're as excited as can be about this launch.

[Operator Instructions] Our next question comes from Emily Bodnar with H.C. Wainwright.

I'm curious how much of a larger sales force would you need to bring TTFields to market for lung cancer. Are you looking to build like a completely new sales force for that? Or do you think there's some synergy with your ongoing sales force in GBM? And then could you maybe provide some background on the METIS trial and what's kind of driving the slower enrollment there?

Sure. So we'll take this in 2 parts but we alluded to this in the remarks. But we are making very large investments in the organization for the future. And I'd like Pritesh to describe some of those activities.

Yes. Thank you, Bill. I appreciate the question and I'll start off with answering your question first. How large of an investment are we going to be making in the sales organization? So -- and will it be a dedicated sales team? And I think one of the key takeaways from what we shared and Frank just talked about with the CNS infrastructure is that we're excited about the focus on GBM while we work on how to structure and how to resource the opportunity in the future. So it's too early for us to say that we will have a sales force just of lung cancer or just of ovarian cancer. What we're excited about is taking this journey of helping more patients. And what we're doing on this front, number one, is to ensure the broader medical oncology community is aware of Tumor Treating Fields. And this is the work that Bill described in the prepared remarks related to the launch of the Tumor Treating Fields therapy website and the work we're doing on education related to the mechanism of action. The second step we’re taking here is to understand the marketplace as we await the data, working on the patient journey, ensuring we understand how decisions are made, how TTFields will insert into the decision-making framework. And then the last step on this front is to make sure that we’re preparing the organization for these milestones that will come forward, so a lot happening on the planning front as we await the data. Once we see the data and have a chance to digest the data, we’ll have more opportunities to think about what are the right plans and where do we make sure that we can make some decisions off of that.

And Emily, with respect to your question on METIS: METIS has been enrolling consistently. We're right near the end. We have line of sight. It's just going to cross over into the next quarter. So nothing more than that.

[Operator Instructions] Our next question comes from Jason Bednar with Piper Sandler.

Maybe I’ll a few here first on LUNAR with a couple of clarifying questions. First, it looks like the early language was removed from the press release early Q1 but I thought I heard you reference that early point for the top line data during the prepared remarks, so just clarifying that the timing there is unchanged. We’re still thinking about early ‘23, as in like sometime in like maybe mid-January. And then I think you noted we’ll see primary and secondary end points from LUNAR. I’m just wondering if you can discuss whether we’ll see any hazard ratios when you report those items. And then finally, can you discuss what kind of preparations you’re making today just with respect to like submission materials, the FDA and international agencies; as well as your planning with payers to have those conversations start as soon as possible once you do have that data fully in hand and cleaned?

Sure. So first and foremost, let me just underline there's no change with respect to the report timing, so no need to read any tea leaves there. Secondly, as we've said before, our first announcement in January, you should expect to be consistent with other announcements from other companies in oncology. We plan to make sure everyone understands whether or not we've hit the primary and the secondary end points. We do not expect to provide detail that will compromise our ability to either publish or present the data in the first opportunity that we have in a major medical conference. And then with respect to preparation, I would say that our regulatory capacity is one of our tremendous strengths at Novocure. It's among our strongest core capabilities. And we are doing everything that is possible to do to prepare. This is -- will be a PMA supplement. It will go in, in 3 subcategories. There's a manufacturing supplement. There is a preclinical supplement and then there's the data package. All of that is being prepared and worked on so that it can be filed at the first opportunity.

Okay. Just another question and I’ll come back to the – Bill you said PMA supplement. I’ve been operating under the assumption this was going to be a full PMA. Is that – has something shifted or…

And your -- good catch. I'm thinking PMA supplements because we're so busy doing other PMA supplements but this is a full new PMA.

Okay, okay. And then Ashley, are you willing at all to provide some view on pricing or revenue per patient in some of your markets? I guess I know the original discussion was to reference – for us on the Street to reference year-end ‘21 revenue per patient levels but I mean I think we all can see like what FX is doing across your P&L and changes in Germany that just make it – making year-end ‘21 that – just really tough to use. Is there anything you’re willing to reference today as we think about modeling revenue per patient in future quarters and years across your respective markets?

Yes. No, I appreciate it. It's actually a good question. So notwithstanding all of the puts and takes, year-end 2021 still is a pretty good reference. So when we roll up to that kind of ASP that you see there, that's what I would recommend you use. As you noted, there will be puts and takes. And what we've seen throughout 2023 is some tailwind from aged claims in the U.S. that's benefiting that price when you roll it in the model but that's being offset by the transition that we're seeing in Germany. And I would say those are netting to essentially the same place. Japan, of course, also had some FX impacts but that price is stable, so if you look at actually those trends over time, you're seeing the impact of FX. So I would still recommend you look to that Q4 exit ASP as a good number to model looking -- moving forward, with some puts and takes in each region.

So year-end ‘21 global revenue per patient is still how you suggest modeling forward for ‘23 and beyond.

Yes.

[Operator Instructions] Our next question comes from Vijay Kumar with Evercore.

Ashley, maybe my first one is for you. Did you quantify what the CMS contribution was for – within the Q.? And just based on what you’re seeing right now, should we expect revenue growth in fiscal ‘23?

Yes, Vijay, thanks for the question. So I mean we've never broken down at -- a detailed quantification but what we have seen is a benefit throughout 2023 and in 2022 from aged claims in the U.S. That's around $10 million a quarter, if you want a round number that I would look. We did have a headwind in the third quarter where that was down versus Q2. And if you look at consistent, you can see that drop in our net revenue in the U.S. And that is largely the impact of the aged claims decrease in the U.S. It is true that, as we look to next year, we expect those aged claims to become more difficult to get. We've kind of largely captured the low-hanging fruit there and so as you look forward, we would recommend you take our active patient therapy. Multiply it by that ASP that we just discussed with Jason and times that by 12 and that will give you a good estimate.

I guess, isn’t the back payments a headwind for ‘23? So could total revenues be declining in ‘23?

Yes, no but aged claims in the U.S. will be a headwind in 2023. We want you to anchor to that ASP that we just referenced.

Understood. And a couple of questions on LUNAR given this is a PMA. There were some trial design changes. Do you expect that there could be an FDA AdCom on -- for this trial?

So you -- we never know whether or not the FDA will decide that they want an AdCom. I don't think it has anything to do with trial design. I think it will have to do with the data and the results and what the FDA chooses to do. I think the fact that Tumor Treating Fields is now established in GBM and is an established modality -- and of course, the safety is well established. I think this is a therapy that's much better understood at the FDA and in the community. Recall they did have an AdCom for our very first approval in recurrent GBM but they did not require an AdCom for our second submission in newly diagnosed.

That's helpful, Bill. And then maybe my last one on. [Indiscernible] the LUNAR trial specifically. We're looking at 12 months of follow-up, right? Does that mean the median overall survival in this trial is less than 12 months? Or maybe just put the 12 month into context because I know there was data maturity. The trial started enrolling a while ago. What does the 12 months signify?

Again, Vijay, that’s 12 months from the last patient in. It’s not an average 12-month follow-up, so I don’t think there’s any issue with respect to this follow-up time.

At this time, there are no other questions in the queue. I would now like to turn the conference back to Bill Doyle for closing remarks.

So, I'd like to thank everyone for joining the call this morning and your continued interest in Novocure. Q3 was another quarter of consistent execution across Novocure. The fundamentals of our GBM business are strong and the underlying evidence confirming the benefits of Tumor Treating Fields therapy continues to strengthen. January marks the beginning of a year that will feature readouts from multiple pivotal trials, potentially enabling us to treat tens of thousands of new patients in the coming years. 2023 will be transformational and we look forward to updating you on our progress. So, thanks, again.

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